DE102013225399A1 - Bicuspid aortic sinus prosthesis - Google Patents

Abstract

The invention relates to an aortic sinus prosthesis with a bulbusförmigen portion, wherein the prosthesis in the longitudinal direction of the portion extending orientation means which are spaced apart from each other in the circumferential direction of the portion, and / or the prosthesis in the circumferential direction of the portion unevenly formed Einzelbweitungen (Einzelbulbi).

Description

Field of application and state of the art

The invention relates to an aortic sinus prosthesis with a bulbusförmigen section.

The replacement of near-heart areas of the aorta, in particular the so-called aorta ascendens, is one of the most important tasks of modern cardiac surgery. For this purpose, a variety of vascular prostheses is now available. The vascular prostheses are usually implanted after removal of aneurysmal parts of the ascending aorta, and especially after removal of the aortic bulb (bulb aortae) to obtain the aortic valve (Valva aortae) and parts of the aortic wall.

The aortic valve is one of the four heart valves. It is located at the end of the outflow tract of the left heart and usually consists of three crescent-shaped, approximately equal sized aortic sails, the valvular semilunares or semilunar valves, which are located at the junction of the ventricular exit and the aorta. With regard to the three aortic sails, one also speaks of a tricuspid aortic valve. The connection between two adjacent aortic sails in the area of the aortic wall is called commissure. A tricuspid aortic valve thus has three commissures. If the circumference of the aorta is described approximately by a circle and the three commissures as a circle point, then the position of each of these points can be characterized by its neighbors through a midpoint angle of about 120 °. Accordingly, an aortic leaflet can be approximately described as a third circle.

Above the aortic valve, the wall of the aorta aligns with the three sinus valsalvae, each of which accommodates one of the three aortic leaflets with the heart valve open and together form the aortic bulb. In a normal heart valve, the three sinus valsalvae are about the same size according to the aortic sails and delimited from each other by constrictions. The constrictions are roughly in line with the commissures. Each of these two sinus valsalvae originates from one of the two coronary arteries (Arteriae coronariae), which are also responsible for the naming of the aortic sails (cf. 1a . 1b ):

From the associated sinus valsalvae of the right coronary aortic sail (Valvula semilunaris dextra) arises from the right coronary artery (Arteria coronaria dextra).

From the associated sinus valsalvae of the left coronary aortic sail (Valvula semilunaris sinistra) arises the left coronary artery (Arteria coronaria sinistra).

The non-coronary sinus valsalvae is associated with the noncoronary aortic sac (Valvula semilunaris posterior).

The natural anatomical conditions of the aortic bulb are generally depicted satisfactorily in today's aortic sinus prostheses. For example, is from the EP 1 935 375 A1 a woven aortic sinus prosthesis with a bulbusförmigen section, wherein the bulbusförmige section may have three Einzelbulbi. In this Einzelbulbi there are three arranged in the circumferential direction of the bulbusförmigen section individual widening, which simulate the natural sinus valsalvae.

However, replacement of the ascending aorta is problematic in patients who have an aortic valve anomaly in the form of a bicuspid aortic valve with three associated sinus valsalvae. Bicuspid aortic valves have two sails, with one sail usually larger than the second. In contrast to the true bicuspid aortic valves, bicuspid aortic valves show a different degree of central tissue thickening, the so-called raphe. The raphe is due to a pre- or post-natal fusion of two aortic leaflets of a primary tricuspid valve, i. with three applied sine, back. The raphe of a bicuspid aortic valve with unequal sails is found in different orientations, depending on which parts of the sail have merged. Fusion of left and right coronary aortic sails is most common.

Since generic aortic sinus prostheses map this valve anomaly only inadequately, their use leads to an increased susceptibility to wear of the aortic valve.

From a surgical perspective, there is an actual need for aortic sinus prostheses that allow successful treatment of bicuspid aortic valves.

Task and solution

Against this background, the object of the present invention was to provide an aortic sinus prosthesis which avoids the disadvantages known from the prior art and, in particular, makes it possible to successfully treat patients who suffer from a bicuspidised aortic valve.

This object is achieved by an aortic sinus prosthesis with the features of independent claim 1. Preferred embodiments of the aortic sinus prosthesis are defined in the dependent claims 2 to 18. The wording of all claims is hereby incorporated by express reference into the content of the present specification.

The invention proposes an aortic sinus prosthesis with a bulbus-shaped section.

Compared to generic prostheses, the aortic sinus prosthesis according to the invention is characterized in particular in that it has in the longitudinal direction of the bulbusförmigen section extending orientation means which are spaced apart from each other in the circumferential direction of the bulbusförmigen portion.

Alternatively or additionally, the prosthesis in the circumferential direction of the bulbusförmigen portion unevenly formed individual widening, so-called Einzelbulbi on.

For the purposes of the present invention, the term "orientation means" should be understood as meaning means which are designed to act as orientation aids for the treating surgeon during the implantation of the aortic sinus prosthesis according to the invention.

For the purposes of the present invention, the expression "bulbus-shaped section" should be understood to mean a prosthesis section whose inner surface is at least partially provided as a contact surface for the sinus valsalvae of a bicuspid aortic valve.

The bulbusförmige section has over other, in particular the remaining, prosthesis sections preferably a circumferentially expanded inner diameter, wherein the expanded inner diameter may be caused in particular by the above-mentioned Einzelbulbi or Einzelbulbi.

For the purposes of the present invention, the term "unevenly formed individual widenings" is to be understood as meaning individual widenings which differ from one another in particular with regard to their share of the lateral surface of the bulbus-shaped section and / or with regard to their degree of curvature or curvature.

The individual widenings or Einzelbulbi may be formed belly, drop and / or onion-shaped.

• • Die Anwesenheit der Orientierungsmittel und/oder der Einzelaufweitungen im bulbusförmigen Prothesenabschnitt erlauben eine einfachere, schnellere und vor allem präzisere Implantation der Aortensinusprothese. Da die chirurgische Behandlung einer Aortenklappenanomalie generell einen komplizierten Eingriff darstellt, stellt die verbesserte Handhabung einer in diesem Kontext bereitgestellten Prothese einen wesentlichen Vorteil dar, und zwar nicht nur für den behandelnden Chirurgen, sondern auch für den betroffenen Patienten.
• • Die Orientierungsmittel und/oder die Einzelaufweitungen können zudem derart angeordnet bzw. ausgebildet sein, das eine in Bezug auf die anatomischen Gegebenheiten einer bikuspidalisierten Aortenklappe optimale Implantation möglich ist. Auf diese Weise kann insbesondere der Orientierung sowie den Freiheitsgraden der Aortensegel einer bikuspidalisierten Aortenklappe ausreichend Rechnung getragen werden.
• • Die Einzelaufweitungen sind mit besonderem Vorteil derart ausgebildet, dass ein Anlegen der Aortensegel während der Herzauswurfphase an die Innenwand der Aortensinusprothese nicht möglich ist. Hierdurch lassen sich vorzeitige Verschleißerscheinungen der Aortenklappe infolge erhöhten Stresses verhindern, wenigstens jedoch signifikant reduzieren.
• • Schließlich besteht ein weiterer Vorteil darin, dass sich sowohl die Orientierungsmittel als auch die Einzelaufweitungen bei der Herstellung der Aortensinusprothese, insbesondere bei Herstellung eines schlauchförmigen Prothesenrohlings, ohne größeren Aufwand realisieren lassen. Nennenswerte Mehrkosten fallen somit bei der kommerziellen Herstellung der Aortensinusprothese nicht an.

By means of the aortic sinus prosthesis according to the invention, in particular the following advantages can be realized:

• • The presence of the orientation means and / or the individual widenings in the bulbus-shaped prosthesis section allow a simpler, faster and, above all, more precise implantation of the aortic sinus prosthesis. Since surgical treatment of aortic valve anomaly is generally a complicated procedure, the improved handling of a prosthesis provided in this context represents a significant advantage, not only for the treating surgeon but also for the patient concerned.
• The orientation means and / or the individual widenings can also be arranged or designed in such a way that an optimal implantation with respect to the anatomical conditions of a bicuspid aortic valve is possible. In this way, in particular the orientation and the degrees of freedom of the aortic sails of a bicuspid aortic valve can be sufficiently taken into account.
• • The individual expansions are designed with particular advantage such that it is not possible to apply the aortic sails during the cardiac output phase to the inner wall of the aortic sinus prosthesis. This can prevent premature wear of the aortic valve due to increased stress, but at least significantly reduce.
• Finally, there is a further advantage in that both the orientation means and the individual widenings in the production of the aortic sinus prosthesis, in particular in the production of a tubular prosthesis blank, can be realized without much effort. Significant additional costs are thus not incurred in the commercial production of the aortic sinus prosthesis.

In principle, the orientation means can also extend over other prosthesis sections in their longitudinal direction.

According to the invention, it may be preferable for the orientation means to extend continuously in the longitudinal direction of the aortic sinus prosthesis.

In an alternative embodiment, the orientation means extend exclusively over the bulbusförmigen portion of the aortic sinus prosthesis.

The bulbusförmige section preferably has a total of three orientation means.

In a further embodiment, the bulbus-shaped section has two orientation means, which in each case extend to their two adjacent orientation means in the circumferential direction of the Bulbusförmigen section have different distances.

In a further embodiment, the bulbusförmige section on an orientation means, which in each case has the same distance to its two adjacent orientation means in the circumferential direction of the bulbusförmigen portion.

The orientation means can furthermore be designed in particular in three dimensions or have a three-dimensional structure. Suitable embodiments will be described in more detail below.

The orienting means may in further embodiments on the inner surface, on the outer surface and / or in the wall, i. be formed between the inner and the outer surface, the aortic sinus prosthesis.

According to the invention, it is preferred if the orientation means are respectively integrated into the wall of the aortic sinus prosthesis or are part of the prosthesis wall.

Alternatively, it may be preferred if the orientation means are each formed on the outer surface of the aortic sinus prosthesis. For example, the orientation means may each be fastened to the outer surface of the aortic sinus prosthesis, in particular sewn, glued, printed, welded, knitted or woven.

In a further embodiment, the orientation means are formed linear. In other words, the orientation means can be orientation or guidance guidelines.

The orientation means may in particular have a straight-line design. Alternatively, the orientation means may not be formed in a straight line, for example arc, spiral, meander, zigzag, serpentine and / or sinusoidal.

In a further embodiment, the orientation means have interruptions. In particular, the orientation means may each be multi-row and interrupted. For example, the orientation means may be designed in the form of a plurality of yarn nodes, in particular arranged in series.

In a further embodiment, the orientation means are flat, in particular strip-shaped, formed.

In a further embodiment, the orientation means are visual and / or haptic perceptible orientation means.

For example, the orientation agents may be colored. In particular, the orientation means may have a coloration based on a different color from red (vivid color). Suitable colored colors may be selected from the group comprising violet, blue, green and yellow. Corresponding dyeings can be achieved, for example, by means of dyes which are soluble in organic solvents, in particular ketones. Exemplary at this point are the dyes D & C (Drug & Cosmetic) no. 2 and / or D & C (Drug & Cosmetic) no. 6 called.

In an alternative embodiment, the orientation agents have a coloration which is based on an achromatic color, preferably on the color black. A black coloration can be produced, for example, with pyrolytic carbon, in particular in the form of a coating on the outer surface of the aortic sinus prosthesis.

The orientation means comprise in a further embodiment a radioopaque material or are formed from such a material.

For example, the orientation agents may comprise barium sulfate, in particular in the form of particles or a superficial coating.

Alternatively, the orientation means may be formed from a radio-opaque metal or a radio-opaque metal alloy. Suitable metals may be selected from the group consisting of gold, iridium, platinum, tantalum, nickel, titanium, and combinations thereof. Suitable radiopaque metal alloys may be selected from the group comprising cobalt-based alloy, in particular cobalt-chromium alloy, and nickel-titanium alloy, in particular nitinol.

The orienting agents in a preferred embodiment have a textile structure.

Particularly preferably, the orientation means each comprise at least one thread or are each formed from at least one thread. In particular, the orientation means can each be designed as at least one monofilament, at least one pseudomonofilament or at least one multifilament, in particular a plied multifilament.

According to a further embodiment, the orientation means are incorporated into a textile structure of the aortic sinus prosthesis, preferably woven or knitted. In the case of a woven Aortic sinus prosthesis may be each a warp thread in the orientation means.

In particular, the orientation means can additionally be incorporated into a textile structure of the aortic sinus prosthesis or introduced, in particular woven or acted on. For example, the orientation means may each be at least one additional thread incorporated into a textile structure of the aortic sinus prosthesis.

The orientation means can each additionally or alternatively be drawn or introduced into a pile thread or velor thread into a textile, usually woven, structure of the aortic sinus prosthesis. In particular, the orientation means can each be designed in the form of a pile thread or a velor thread.

According to a further embodiment, the orientation means are each configured in the form of at least one thread, wherein the at least one thread, for example, in terms of titer or yarn thickness, thickness or diameter, thread material, fiber or filament number, type of bond, in particular textile weave, and / or Texturing may differ from other sutures of the aortic sinus prosthesis.

For example, the at least one thread may have a higher titer or a higher yarn count, a thicker diameter and / or a higher fiber or filament number than other threads of the aortic sinus prosthesis.

Thus, in a further embodiment, the at least one thread can have a titre or a yarn thickness of 5 dtex to 250 dtex, in particular 20 dtex to 150 dtex, preferably 60 dtex to 100 dtex.

In a further embodiment, the at least one thread may have a diameter or a thickness of 1 μm to 500 μm.

Furthermore, the at least one thread can have a fiber number of 20 to 200, in particular 40 to 150, preferably 50 to 110. By contrast, other sutures of the aortic sinus prosthesis may, for example, have a smaller number of fibers.

Furthermore, it can be provided according to the invention that the at least one thread has a texturing, whereas other threads of the aortic sinus prosthesis are free from texturing, i. not textured.

The orientation means comprise in another embodiment a thermoplastic material or are formed from such a material. Suitable thermoplastic materials are generally polymers which may be selected from the group comprising polyethylene, polypropylene, polytetrafluoroethylene (PTFE), in particular expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, polyamides, copolymers thereof and mixtures, in particular blends, from that.

Furthermore, the orientation means, in particular in each case in the form of at least one thread, be encased by a hot melt adhesive. The hot melt adhesive may only partially or completely orient the orienting agents, i. full surface or continuous, sheathing. For example, each of the orienting agents may be encased in a hot melt adhesive selected from the group consisting of poly-1-butene, 1-butene copolymers, polyamides, polyethylene, amorphous poly-α-olefins, ethylene-vinyl acetate copolymers, polyester elastomers, polyurethane Elastomers, polyamide elastomers, vinylpyrrolidone-vinyl acetate copolymers, and blends, especially blends, thereof.

In a further embodiment, the orientation means are each formed as a textile fabric. The sheet may basically be a woven or knitted fabric. Preferably, the sheet is strip-shaped and in particular net-shaped.

In a further embodiment, the orientation means are each raised or formed in the form of at least one elevation.

The orientation means may in each case in particular have a plurality of threads arranged one above the other and / or several juxtaposed ones. The threads arranged one above the other can not be connected to one another in a textile manner, for example glued or welded together. The juxtaposed threads may, for example, be linked to one another by way of another type of weave, in particular other weave or weave, than other threads of the aortic sinus prosthesis.

According to a further embodiment, the orientation means are each formed in the form of at least one recess or depression on the outer surface of the aortic sinus prosthesis. The at least one recess or recess may be formed during the manufacture of the aortic sinus prosthesis by omitting at least one thread in the longitudinal direction of the bulbusförmigen portion formed during the manufacturing process. To form the at least one recess or recess, for example, one or more pile threads or velor threads during the preparation of the aortic sinus prosthesis be omitted.

According to a further embodiment, the orientation means each have or represent a surface pattern. The surface pattern may be selected from the group comprising polygonal surface patterns, line surface patterns, graphical symbols, slogans, motifs, and combinations thereof.

Suitable polygonal surface patterns may be selected from the group consisting of triangular surface pattern, rectangular surface pattern, square surface pattern, checkered surface pattern, diamond-shaped surface pattern, pentagonal surface pattern, hexagonal surface pattern, star-shaped surface pattern, and combinations thereof.

In particular, the surface pattern may be an embossed pattern. The surface pattern in a further embodiment is not a pleating pattern.

In another embodiment, the orientation means each have a different surface pattern, preferably a different embossing pattern, than the remaining outer surface of the aortic sinus prosthesis. Corresponding aortic sinus prostheses can be produced, for example, by means of special embossing plates which have two different embossing patterns.

According to the invention, it can further be provided that, in the case of orientation means formed on the outer surface of the aortic sinus prosthesis, the remaining outer surface of the aortic sinus prosthesis, if appropriate apart from a pleating, is free of a surface pattern, preferably embossing pattern.

In an alternative embodiment, in the case of orientation means formed on the outer surface of the aortic sinus prosthesis, these, in contrast to the remaining outer surface of the aortic sinus prosthesis, are free of a surface pattern, in particular devoid of an embossing pattern and / or pleating pattern.

In a further embodiment, the orientation means are formed differently. For example, the orientation means may differ from one another with respect to one or more of the previously described orientation means variants. In order to avoid unnecessary repetition, reference is therefore expressly made to the previous description.

As already mentioned, the aortic sinus prosthesis according to the invention, in addition to or as an alternative to the orientation means extending in the longitudinal direction of the bulbus-shaped section, which are spaced differently from one another in the circumferential direction of the bulbus-shaped section, may have unevenly formed individual expansions (single bulbs) in the circumferential direction of the bulbus-shaped section.

The individual widenings are preferably designed such that they simulate the sinus valsalvae of a bicuspid aortic valve.

The bulbusförmige section has in a preferred embodiment a total of three individual widenings.

The individual widenings are preferably enclosed by non-expanded, extending in the longitudinal direction of the bulbusförmigen section intermediate areas. In the area of these intermediate areas, the aortic sinus prosthesis has a smaller inner diameter than in the region of the individual widenings. The intermediate areas themselves may be formed linear. Preferably, the intermediate areas are arranged so that they are after implantation of the aortic sinus prosthesis in line with the commissures of a bicuspid aortic valve.

In a further embodiment, the individual widenings are bordered by the orientation means along the longitudinal direction of the bulbusförmigen portion. The orientation means may in particular extend along the intermediate regions mentioned in the previous paragraph in the longitudinal direction of the bulbus-shaped section. With particular advantage, the orientation means extending in the intermediate regions characterize the extent of the individual widenings. In this way, the surgeon is enabled to position the aortic sinus prosthesis during implantation such that the commissures of a bicuspid aortic valve are each in line with one of the orienting means.

This ensures that the aortic sails can easily fit into the single dilatations of the aortic sinus prosthesis when the aortic valve is open.

• • Typ 1, L/R: Verschmelzung von links- und rechtskoronarem Aortensegel
• • Typ 1, R/N: Verschmelzung von rechts- und nichtkoronarem Aortensegel
• • Typ 1, N/L: Verschmelzung von nicht- und linkskoronarem Aortensegel
• • Typ 2, L/R-R/N: Verschmelzung von links- und rechtskoronarem Aortensegel und von rechts- und nichtkoronarem Aortensegel
• • Typ 2, R/N-N/L Verschmelzung von rechts- und nichtkoronarem Aortensegel und von nicht- und linkskoronarem Aortensegel
• • Typ 2 N/L-L/R Verschmelzung von nicht- und linkskoronarem Aortensegel und von links- und rechtskoronarem Aortensegel

An exact position determination of the aortic sinus prosthesis during implantation is also important in view of the above-mentioned, different embodiments of a bicuspid aortic valve. These aortic valve designs can be classified as follows:
The bicuspid aortic valve can vary depending on the number of raphe, the arrangement of the Sails and the raphen as well as the functional status of the flap in the "type 1" (a raphe) and the "type" 2 (two raphe) are classified. As mentioned in the introduction, although three aortic sails (left, right and non-coronal sails) are created with their corresponding sinus valsalvae, two of the aortic sails are fused together or fused together. Since the merger (s) or raphe (s) can be observed at three different positions, subgrouping is based on the position of the raphe (n):

• • Type 1, L / R: Merging of left and right coronary aortic sails
• • Type 1, R / N: Merging of right and noncoronary aortic sails
• • Type 1, N / L: Fusion of non-coronary and left coronary aortic sails
• • Type 2, L / RR / N: Merging of left and right coronary aortic sails and right and noncoronary aortic sails
• • Type 2, R / NN / L Fusion of right and noncoronary aortic leaflets and non-and left coronary aortic leaflets
• • Type 2 N / LL / R Fusion of non-and left coronary aortic leaflets and left and right coronary aortic leaflets

For further details on this classification system of bicuspid aortic valves, see the thesis of Anja Kumme's "Classification of bicuspid aortic valves" (Lübeck 2007) and the publication "A classification system for the bicuspid aortic valve from surgical specimens" (The Journal of Thoracic and Cardiovascular Surgery, May 2007, Sievers et al.) Referenced.

The bicuspid aortic valves type 1 are in the 2a to 2c illustrated.

By means of the aortic sinus prosthesis according to the invention, bicuspid aortic valves of both type 1 and type 2 can be successfully treated.

In a further embodiment, the bulbusförmige section may have two unevenly formed individual widenings.

Alternatively or in addition, the bulbusförmige section may have two uniformly formed individual widenings.

In preferred embodiments, the bulbusförmige section has two uniformly formed individual widenings and a further single expansion, which is different from the two uniformly formed individual widenings.

In a further embodiment, a single expansion has a greater proportion of the lateral surface of the bulbusförmigen portion of the aortic sinus prosthesis as two further, preferably uniformly formed, individual widenings.

An individual expansion of the aortic sinus prosthesis preferably has an area fraction of 30% to 50%, in particular 34% to 46%, based on the lateral surface of the bulbus-shaped section.

In a further embodiment, two individual widenings have the same proportion on the lateral surface of the bulbus-shaped section.

In particular, two individual widenings of the aortic sinus prosthesis can each have an area fraction of 25% to 35%, preferably 27% to 33%, based on the lateral surface of the bulbus-shaped section.

In a further embodiment, the aortic sinus prosthesis according to the invention additionally has a heart-shaped and preferably tubular section (so-called annulus section), which adjoins below the bulbus-shaped section.

Alternatively or additionally, the aortic sinus prosthesis according to the invention may have a heart-distal and preferably tubular section, which adjoins above the bulbus-shaped section and optionally passes into an aortic arch.

Furthermore, it may be preferred that the optionally provided near-the-heart and / or the optionally provided area remote from the heart have pleats, in particular pleats extending in the circumferential direction.

By contrast, the bulbus-shaped section can be free of pleats or, in order to improve the function of the atrial sinus, function in the longitudinal direction of pleating folds.

Furthermore, if appropriate, the near-the-heart and / or the possibly remote-from-the-heart section (and / or the possibly provided aortic arch) may have a Inner diameter of 10 mm to 50 mm, in particular 24 mm to 36 mm.

The aortic sinus prosthesis can basically be a non-textile prosthesis. For example, the aortic sinus prosthesis can be configured as a nonwoven prosthesis, in particular a spray nonwoven prosthesis.

Preferably, however, the aortic sinus prosthesis is a textile prosthesis, i. a prosthesis with textile structure.

The aortic sinus prosthesis is particularly preferably a woven or knitted prosthesis.

According to a further embodiment, the aortic sinus prosthesis or threads thereof may comprise a polymer or be formed from a polymer which is preferably selected from the group comprising polyolefins, polyesters, polyurethanes, polyamides, copolymers thereof and mixtures, in particular blends, thereof.

The polymer may be selected, for example, from the group comprising polyethylene, polypropylene, polytetrafluoroethylene (PTFE), in particular expanded polytetrafluoroethylene (ePTFE), polyethylene terephthalate, polypropylene terephthalate, polybutylene terephthalate, polyvinylidene difluoride, polytetrafluoropropylene, polyhexafluoropropylene, nylon 6, nylon 6-6, nylon 6- 12, polyester urethane, copolymers thereof, and blends, especially blends, thereof.

In another embodiment, the aortic sinus prosthesis can be provided with active ingredients, preferably selected from the group comprising antimicrobial, in particular antibiotic, active ingredients, disinfectant active ingredients, anti-inflammatory agents, antithrombogenic active ingredients and combinations thereof.

In an expedient embodiment, the aortic sinus prosthesis is in a sterilized and in particular preformed form.

Further features and advantages of the invention will become apparent from the following description of preferred embodiments in the form of figures, description of figures and an embodiment and the dependent claims. In this case, individual features can be realized individually or in combination with each other. The preferred embodiments are merely for further explanation and understanding of the invention without limiting it thereto.

figure description

The figures show schematically:

1a a natural human aortic valve,

1b : A simplified representation of a natural human aortic valve to illustrate the classification system of bicuspid aortic valves,

2a : a simplified representation of a bicuspid aortic valve type I, L / R,

2 B : A simplified representation of a bicuspid aortic valve type I, R / N,

2c : a simplified representation of a bicuspid aortic valve type IN / L and

3 : An embodiment of the aortic sinus prosthesis according to the invention.

The 1a shows the cross section of a normal human aortic valve 10 , This is tricuspid, ie it consists of three aortic sails (Valvulae semilunares) 11 . 11 ' . 11 '' and three sinus valsalvae 12 . 12 ' . 12 '' , The three sinus valsalvae 12 . 12 ' . 12 '' together form the bulbous dilated aortic bulb (bulbus aortae) 13 , From the left sinus valsalvae 12 ' arises from the left coronary artery (Arteria coronaria sinistra) 14 while from the right sinus valsalvae 12 '' the right coronary artery (Arteria coronaria dextra) 15 arises. Accordingly, the left and right sinuses become valsalvae 12 ' respectively. 12 '' associated aortic leaflet as left coronal sedge (Valvula semilunares sinistra) 11 ' or right-coronal sail (Valvula semilunares dextra) 11 '' designated. The rest of the sinus valsalvae 12 associated aortic leaflet becomes a non-coronary sail (Valvula semilunares posterior) 11 designated. The area where two adjacent aortic sails touch becomes commissure 16 designated. If the heart valve opens, it will strike the three aortic sails 11 . 11 ' . 11 '' due to in the areas of sinus valsalvae 12 . 12 ' . 12 '' widened aortic wall prevented (not shown).

The 1b shows a simplified representation of a natural aortic valve according to 1a , This type of presentation, which is limited to the orientation of the aortic sails, is used in particular to classify bicuspid aortic valves (cf. 2a and 2 B ). The three aortic sails 11 . 11 ' . 11 '' are each represented as one third of a circular area, with the circumference line symbolizing the aortic wall. The point of contact 16 two adjacent sails on the circumference line corresponds to a commissure.

The 2a to 2c show the three major morphological forms of the bicuspid aortic valve type 1 using the 1b chosen representation. The bicuspid aortic valve is classified as type 1, as it is a raphe 18 having. The raphe 18 can occur in three positions between two other aortic sails. In the bicuspid aortic valve are primarily three aortic sails 17 (non-coronary sail), 17 ' (left coronal sail) and 17 '' (right coronal sail) created, where pre- or postnatal two of the sails are merged, from which the raphe 18 results.

The 2a shows the type 1, L / R, ie the left coronal sail 17 ' and the right coronary sail 17 '' are merged together. For Type 2, L / RR / N are additionally the right coronary sail 17 '' and the non-coronary sail 17 fused together (not shown).

2 B shows the type 1, R / N, ie the right coronal sail 17 '' and the non-coronary sail 17 are merged together. In type 2, R / NN / L are also the non-coronary sail 17 and the left coronary sail 17 ' fused together (not shown).

2c shows the type 1, N / L, ie the non-coronary sail 17 and the left coronary sail 17 ' are merged together. For Type 2, N / LL / R are additionally the left coronal sail 17 ' and the right coronary sail 17 '' fused together (not shown).

3 shows an aortic sinus prosthesis according to the invention 100 with a heartfelt section 102 a bulbus shaped section 104 and a heartfelt section 106 , The bulbus shaped section 104 is compared to the near-heart section 102 and the heartfelt section 106 expanded in the circumferential direction. The bulbus shaped section 104 has three circumferentially formed individual widenings 105 . 105 ' . 105 '' on. The two individual widenings 105 . 105 ' are formed uniformly and in particular each have approximately the same proportion of the lateral surface of the bulbusförmigen section 104 on. The single expansion 105 '' is formed in comparison to these uneven and has in particular a larger proportion of the lateral surface. The individual widenings 105 . 105 ' . 105 '' are of three in the longitudinal direction of the bulbusförmigen section 104 extending intermediate areas 103 . 103 ' . 103 '' edged. In the intermediate areas 103 . 103 ' . 103 '' has the aortic sinus prosthesis 100 a smaller inner diameter than in the region of the individual widenings 105 . 105 ' . 105 '' ,

In the longitudinal direction of the aortic sinus prosthesis 100 can also (or alternatively to the individual widenings 105 . 105 ' . 105 '' ) three orientation means 107 . 107 ' . 107 '' extend, wherein the rear-side orientation means 107 '' through a broken line in the upper open area of the aortic sinus prosthesis 100 is indicated. The orientation means 107 . 107 ' . 107 '' can in the longitudinal direction of the aortic sinus prosthesis 100 through the intermediate areas 103 . 103 ' . 103 '' run.

The orientation means 107 . 107 ' . 107 '' are preferably linear, ie designed as so-called orientation or guidelines (Guidelines).

By means of the orientation means 107 . 107 ' . 107 '' a surgeon is capable of the aortic sinus prosthesis 100 To position the commissures of a patient with a bicuspid aortic valve, each in line with one of the orientation means 107 . 107 ' . 107 '' lie. In other words, the aortic sinus prosthesis 100 be positioned so that the endpoints 101 . 101 ' . 101 '' the orientation agent 107 . 107 ' . 107 '' on the edge of the heart-shaped section 102 lie directly above the commissure of a bicuspid aortic valve. This can prevent the aortic leaflets from striking the inner wall of the prosthesis during the cardiac discharge phase, resulting in a reduced susceptibility to wear of the heart valve.

Alternatively, it may be preferred according to the invention that the orientation agents 107 . 107 ' . 107 '' exclusively over the bulbus section 104 extend (not shown).

The orientation means 107 . 107 ' . 107 '' For example, each may be configured as a black-colored thread, which is additionally integrated into the prosthesis structure. With regard to alternative embodiments for the orientation means 107 . 107 ' . 107 '' is fully incorporated by reference to the entire disclosure of the present application.

The heart-shaped section 102 and / or the bulbusförmige section 104 may be unpleated, whereas it may be preferred if the non-cardiac section 106 circumferentially extending pleats 108 having. An unpleated heart-shaped section 102 has the advantage of making it easy to suture this section to the aortic root.

In order to emulate the function of the atmospheric function of the natural aorta better, it may be provided that the bulbusförmige section 104 longitudinally extending Plissierfalten (not shown).

example part

Production of an aortic sinus prosthesis according to the invention

On a loom, a prosthesis blank is prepared for a biscuspidized aortic sinus prosthesis with an inner diameter of 32 mm by temporarily increasing the inner diameter of the hitherto continuously tubular prosthesis tube by 4 mm (total inner diameter: 36 mm in bulbusförmigen section) by weaving lowering on a distance of 3 cm , In addition, in the manufacture of prostheses, three mean pyrolytic carbon black-colored thread-like guidelines are woven directly into the prosthesis structure such that the guidelines are arranged at 2 × 110 ° and 1 × 140 ° offset in the bulbus-shaped section. This is followed by a pleating step of a 20 cm long, heart-removed prosthesis section above the bulbus-shaped section, which is finally cut to 10 cm. On the other hand, a cardiac prosthetic section (annulus section) arranged below the bulbus-shaped section remains unaffected by pleating and is merely cut to a length of 3 cm. In this course, the individual widenings are increased again by means of a thorn and fixed in their shape. Subsequently, the vascular prosthesis is packaged and gamma sterilized. Optionally, the vascular prosthesis may be coated prior to its packaging and sterilization and the coating crosslinked.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 1935375 A1 [0008]

Cited non-patent literature

• Anja Kumme's "Classification of bicuspid aortic valves" (Lübeck 2007) and the publication "A classification system for the bicuspid aortic valve of surgical specimens" (The Journal of Thoracic and Cardiovascular Surgery, May 2007, Sievers et al.) [0074]

Claims (18)

An aortic sinus prosthesis having a bulbus-shaped portion, characterized in that the prosthesis has in the longitudinal direction of the portion extending orientation means which are spaced apart from each other in the circumferential direction of the portion, and / or the prosthesis in the circumferential direction of the portion unevenly formed individual widenings (Einzelbulbi). The aortic sinus prosthesis according to claim 1, characterized in that the orientation means extend exclusively in the longitudinal direction of the bulbusförmigen portion. Aten adenine prosthesis according to claim 1 or 2, characterized in that the bulbusförmige section has a total of three orienting agents. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the bulbusförmige section has two orientation means, each having different distances to its two adjacent orientation means in the circumferential direction of the bulbusförmigen portion. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the bulbusförmige portion having an orientation means which has in each case the same distance to its two adjacent orientation means in the circumferential direction of the bulbusförmigen portion. Aten sinus prosthesis according to one of the preceding claims, characterized in that the orientation means are linear, in particular straight, formed. Aten adenine prosthesis according to one of claims 1 to 5, characterized in that the orientation means are flat, in particular strip-shaped, are formed. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the orientation means are colored. Aten adenine prosthesis according to one of the preceding claims, characterized in that the orientation means comprise a radioopaque material or are formed from such a material. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the orientation means have a textile structure. Aten adenine prosthesis according to one of the preceding claims, characterized in that the bulbusförmige section has a total of three individual widenings. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the individual widenings are bordered by orientation means extending in the longitudinal direction of the bulbus-shaped section along the longitudinal direction of the bulbus-shaped section. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the individual widenings are bordered by non-expanded, extending in the longitudinal direction of the bulbusförmigen portion intermediate portions along the longitudinal direction of the bulbusförmigen portion. Aten adenine prosthesis according to one of the preceding claims, characterized in that the bulbusförmige section has two unevenly formed individual widenings. Aten adenine prosthesis according to one of the preceding claims, characterized in that the bulbusförmige section has two uniformly formed individual widenings. Aten adenine prosthesis according to one of the preceding claims, characterized in that a single widening has a larger proportion of the lateral surface of the bulbusförmigen portion than two further, preferably uniformly formed, individual widenings. Aten adenine prosthesis according to one of the preceding claims, characterized in that two individual widenings have the same proportion of the lateral surface of the bulbusförmigen section. The aortic sinus prosthesis according to one of the preceding claims, characterized in that the prosthesis is a woven aortic sinus prosthesis.

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