The present invention relates to a prosthetic implant of the type comprising: a tubular support of axis X, which can be deformed between a compressed state with a small diameter and a dilated rest state with a larger diameter, the tubular support comprising a lattice comprising substantially rhombus-shaped meshes, each mesh having a first diagonal substantially parallel to the axis X and a second diagonal substantially perpendicular to the axis X; and at least one resilient membrane arranged inside the tubular support.
This type of implant is for example a prosthetic valve designed to replace a defective native valve. In a variant, the implant is a tubular endoprosthesis (referred to in English as a stent) designed to reinforce the wall of a blood vessel or to bridge an aneurism.
In prosthetic valves of the above-mentioned type, a portion of a lateral fixing edge of a membrane is fixed to a fixing mesh of the lattice at two opposite vertices along the first diagonal of the mesh.
However, when passing from the compressed state to the dilated rest state, or the other way round, the distance separating the two opposite vertices varies. Because of this, the portion of the lateral edge of the membrane fixed between these two vertices is subject to a variation in tension.
In particular, after manufacturing of the valve and when it is compressed in order to insert it into an implantation catheter, the increase in the distance between the vertices of the mesh causes longitudinal stretching of the portion of the lateral edge of the membrane which therefore has in increased risk of tearing.
This variation in tension may be taken into account when manufacturing the valve. Thus, the portion of the lateral edge of the membrane is initially fixed under excess tension, so that it is fixed at a suitable tension once the support is deployed after implantation of the valve.
However, it is impossible to predict accurately the diameter of the tubular support in the dilated state as this diameter depends on the elasticity of the tissues surrounding the valve, the morphological characteristics of the patient etc. Consequently, the diameter of the tubular support in the dilated state exhibits significant statistical dispersion and the effective tension of the portion of the lateral edge of a membrane also has a large dispersion.
The object of the invention is to propose an improved implant in which the lateral edges are fixed to the tubular support to provide reliable, long-term functioning of said implant.
Accordingly, the invention relates to a prosthetic implant of the above-mentioned type, which is notable in that the membrane comprises a fixing portion, this fixing portion being fixed to a fixing section delimited by a strand of the tubular support, said fixing section being oriented substantially parallel to the axis X.
According to particular embodiments, the prosthetic implant comprises one or more of the following features:
The invention will be better understood on reading the description below, given solely as an example and with reference to the accompanying drawings, in which:
A prosthetic valve according to a first embodiment of the implant according to the invention is illustrated in
The tubular support 12 comprises a lattice 16. The lattice 16 consists of intertwined, for example braided or woven, threads. In the embodiment in
A thread, such as the thread 20A, is shaped to describe a helix winding in a first, positive direction about the axis X, as indicated by the arrow F1 in
A thread 20 is inserted along a helix successively over and under the threads that it intersects. Other types of intertwining may be envisaged.
Helixes with the same twisting direction are parallel to one another; in other words, they have an identical pitch. This results in the lattice 16 having substantially rhombus-shaped meshes 26. More specifically, each mesh 26 has a downstream vertex 27, an upstream vertex 29, a left vertex 31 and a right vertex 33. The downstream 27 and upstream 29 vertices are opposite one another along a first diagonal 28 of the mesh 26, arranged substantially parallel to the axis X, whereas the left 31 and right 33 vertices are opposite one another along a second diagonal 32 arranged in a plane substantially perpendicular to the axis X. It will be seen in the figures that the meshes 16 are substantially the shape of a square, which is a particular type of rhombus.
The lattice 16 has resilient properties and can be deformed spontaneously from a compressed state, in which it has a small diameter, to a dilated state, known as the rest state, in which it has a larger diameter. Because of this resilience, the tubular support 12 rests against the neighbouring tissues and the pressure applied by the support holds the valve 10 in place. When the state changes, a mesh 26 changes shape.
In the embodiment in
As illustrated in
Each leaf 14 is arranged inside the tubular support 12 and is connected to the lattice 16 by its two lateral edges 44 and 46. The downstream edge 42 remains free. The free downstream edge of a first leaf is suitable for resting against the two halves of the free downstream edges of the two adjacent leaves to prevent the blood from flowing from downstream to upstream along the axis X, and for separating from these other free downstream edges to allow the blood to flow from upstream to downstream along the axis X.
More precisely, the left edge 44 of the leaf 14 comprises a fixing portion 48 which is contiguous with the free downstream edge 42 and is of height e. The left edge 44 comprises a portion 49 which is complementary to the fixing portion 48, and upstream therefrom. The left edge 44 has a left tab 50 extending from the fixing portion 48, perpendicular to the height H originating from the downstream edge 42, in other words in the extension of the downstream edge 42. The height of the tab 50 is equal to e.
The right edge 46 of the leaf 14 comprises a fixing portion 52, contiguous with the downstream edge 42, having a right tab 54 of height e. The right edge 46 comprises a portion 53 complementary to the fixing portion 52, and upstream therefrom.
A leaf 14 is fixed to the lattice 16 so that each downstream portion 48, 52 is fixed in the region of a deformed mesh 26′ of the lattice 16. The lattice 16 comprises as many deformed meshes 26′ as leaves 14. Thus, in the embodiment illustrated in the figures, the lattice 16 comprises three deformed meshes, 26′A, 26′B and 26′C respectively.
An enlarged view of the deformed mesh 26′A is shown in
Similarly, the thread segment 62 is curved at two points, upstream C and downstream D respectively. The thread segment between points C and D forms a right fixing section 66. The curvatures produced on the thread segment 62 in the region of points C and D are such that the thread segment 62 departs from the helix shape in the second twisting direction, towards the inside of the deformed mesh 26′A and such that the right fixing section 66 coincides with the first diagonal of the deformed mesh 26′A.
The length of the fixing sections 65 and 66 is equal to or slightly greater than the height e of the tabs 50 and 54 of a leaf 14.
The fixing of the leaves 14, for example the leaf 14A and the leaf 14B to the deformed mesh 26′A of the lattice 16 will now be described in detail.
On the right side of the leaf 14A, the right edge 46A thereof is fixed along the thread 20A comprising the segment 61 of the fixing mesh 26′A. More specifically, the downstream right portion 52A is fixed to the left fixing section 65 of the segment 61. The portion 53A complementary to the right edge 46A is fixed along the thread 20A, upstream from point B, the thread 20A thus describing a helix in the first twisting direction.
On the left side of the leaf 14B, the left edge 44B is fixed along the thread 20D comprising the segment 62 of the fixing mesh 26′A. More specifically, the downstream left portion 48B is fixed to the right fixing section 66 of the segment 62. The portion 49B complementary to the lateral edge 44B of the leaf 14B is fixed along the thread 20D, upstream from point D, the thread 20D thus describing a helix in the second twisting direction.
A similar description may be given for fixing the left edge of the leaf 14A and the right edge of the leaf 14C in the region of the deformed mesh 26′C, and for fixing the left edge of the leaf 14C and the right edge of the leaf 14B in the region of the deformed mesh 26′B.
It will be noted that the point 45A of the leaf 14A is fixed to the downstream vertex 29 of the mesh 26″A where the thread 20A coming from the deformed mesh 26′A and carrying the right lateral edge 46A of the leaf 14A intersects the thread 20D coming from the deformed mesh 26′C and carrying the left lateral edge 44A of the leaf 14A.
A fixing portion of a lateral edge of a leaf is fixed to the fixing section of a deformed mesh in the following manner. In the region of the deformed mesh 26′A, as illustrated in a front view in
For the adjacent leaf 14B, the left tab 50B of the membrane 14B is inserted between the left 65 and right 66 fixing sections in such a way that the left downstream portion 48B is placed in the region of the right fixing section 66. The tab 50B is then folded in the opposite direction from the tab 54A, so as to surround the fixing section 66. It is applied to the outer surface of the leaf 14B, which is the surface oriented towards the tubular support 12. A fixing staple 70B or a thread holds the tab 50B against the leaf 14B. The fixing section 66 is then received between the tab 50B and the fixing portion 48A.
Advantageously, the two adjacent leaves 14A and 14B are fixed together by an additional staple 72 or a suture point produced by means of a thread.
When the assembly is complete, the fixing portions of two adjacent leaves are edge to edge. These fixing portions are applied to one another and oriented along a generatrix of the tubular support 12, in other words parallel to the axis X.
When the support 12 is deformed to change from the dilated rest state to the compressed state, a fixing section of a deformed mesh substantially retains its length and remains oriented substantially parallel to the axis X, as illustrated in
Moreover, being made integral with a fixing section by the folding of a tab, the fixing portion of a leaf is not really put under tension along the fixing section. It is the tabs which provide some rigidity to the fixing portion. The fixing section may slide slightly inside the loop formed by the folded tab.
In this way, the problems of variation in tension along the downstream portion of the lateral edge of a leaf during deformation of the support are overcome.
In this way, the complementary portion of a leaf is sewn from the downstream direction, near the fixing portion, to the upstream direction, near the point of the leaf. A method used to fasten off the suture thread 75 is illustrated in detail in
A variant embodiment of a leaf has been illustrated in dashed lines in
A second embodiment of a prosthetic valve has been illustrated in
An additional thread 80 has characteristics identical to those of a thread 20. In the embodiment of
An additional thread 80, for example the thread 80A, is shaped to form a U-shaped hairpin 82. The hairpin 82 comprises two left and right fixing sections 85 and 86 respectively arranged parallel to the axis X. The hairpin 82 is positioned so that its upstream end, corresponding to the rounded portion of the hairpin, is situated in the region of the downstream vertex 27 of a fixing mesh 126′A.
The right and left downstream portions 52A and 48B respectively of two adjacent leaves 14A and 14B are fixed to each of the fixing sections 85 and 86 respectively of the additional thread 80A. The right and left complementary portions 53A and 49B respectively are fixed upstream from the vertex 27 of the fixing mesh 126′A along the threads 20A and 20D of the lattice passing through said vertex 27.
In the second embodiment, the lateral edge of a leaf is fixed to a fixing section by folding the tab carried by the lateral edge, as described above.
A variant of the second embodiment is illustrated in
The threads 90 and 91 are mounted on the lattice 216 opposite one another in such a way that a longitudinal segment 90B of the first thread 90 and a longitudinal segment 91B of a second thread 91 coincide with the first diagonal 28 of a fixing mesh 226′ of the lattice 216, for example the mesh 226′A.
The fixing portion of the lateral edge of a leaf is fixed to a longitudinal section 90B of an additional thread 90 or 91 in the vicinity of the downstream vertex 27 of the fixing mesh 126′A. The complementary portion of the lateral edge is fixed to a thread 20 of the lattice 116 coming from said vertex 27.
In this second embodiment, the configuration of the additional threads is such that they have a fixing section which is slightly influenced by the deformation of the lattice when the valve is deformed.
The lattice 316 of the tubular support 312 comprises deformed meshes 326′,
The downstream edge 42 of the membrane 314 is free. The upstream edge 345 of the membrane 314 is fixed, in the region of fixing portions, to the fixing segments of the lattice 316 by stitches 319.
A stitch 319 of this type has been shown in detail in
The membrane may be fixed at as many points as necessary. The number of deformed meshes is therefore unlimited.
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09 54826 | Jul 2009 | FR | national |
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