EP2421485A1

EP2421485A1 - Gastric ring with facets

Info

Publication number: EP2421485A1
Application number: EP10713944A
Authority: EP
Inventors: Pascal Paganon
Original assignee: Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Current assignee: Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Priority date: 2009-04-21
Filing date: 2010-04-15
Publication date: 2012-02-29
Also published as: US20120041458A1; BRPI1015029A2; WO2010121936A1; FR2944430A1

Abstract

The invention relates to an implantable surgical ring (1) intended for being placed around a biological organ forming a bag in order to modify the flow area thereof, said ring comprising a flexible strip (2) capable of winding around an axis (X-X') to form a loop around the organ and which has one ventral surface (10). Said flexible strip (2) is preformed such that the ventral surface is curved around said axis (X-X') and divided into a plurality of contiguous and intersecting facets (20, 120, 220, 320) which are connected to one another by transition areas (21, 121, 221) forming predefined hinging creases with angle coverage with respect to the axis (X-X') of no more than 5°, each facet (20, 120, 220, 320) covering an angle sector substantially between 15° and 35°.

Description

GASTRIC RING WITH FACETS

The present invention relates to the general field of implantable medical devices, and more particularly to surgical rings, such as sphincters or gastric rings which are intended to be implanted around the stomach or the esophagus in the context of a treatment for obesity.

The present invention more particularly relates to an implantable surgical ring intended to be placed around a biological organ constituting a pocket or a conduit in order to modify the passage section of said biological organ, said ring comprising a flexible band which is suitable for wrap around an axis (X-X ') to form a loop around the member and which has a ventral surface adapted to come into contact with said member.

It is known to treat patients with severe obesity by implanting the latter with a gastric band that surrounds and squeezes the stomach to limit food intake.

Such rings can be placed either around the intact stomach, to directly perform a gastroplasty, or after a "by-pass" operation during which the surgeon has previously surgically remodeled the stomach to create a pocket of reduced dimensions.

In the latter case, the purpose of the ring is to oppose the dilatation of the surgically formed gastric pouch, to prevent the human body from adapting by creating a kind of new stomach upstream of the previous one, and thus lessen the therapeutic efficacy of the intervention. Although they generally provide satisfaction, the rings of the prior art sometimes suffer from certain disadvantages.

In particular, the use of such rings generally has the effect of creating, by bending, one or more pleats at the ventral surface of the ring which comes into contact with the organ. However, the random appearance of sometimes very pronounced folds may in particular have the effect of excessively constraining the constituent material of the ring, and therefore to make it work fatigue, the risk of causing its damage or local rupture.

Of course, such a failure of the ring can have significant repercussions on its therapeutic effect, particularly if said ring is provided with an inflatable pocket for adjusting the clamping force that said ring exerts on the biological organ.

In addition, the formation of folds can lead to an unequal distribution of the clamping force exerted by the ring on the organ, or even to the pinching of the wall of said organ, which can cause discomfort or pain to the patient, and even, in some cases, cause tissue necrosis. WO2004 / 019671 discloses a gastric ring provided with an inflatable balloon having a plurality of chambers. At the level of its contact surface with the stomach, the balloon has several facets arranged substantially in a circle. These facets are separated by notches. US2007 / 0249893 discloses a stirrup against urinary incontinence. The ether forms a controlled sphincter to achieve a more or less significant tightening of the biological conduit therethrough. The stirrup comprises a balloon formed of several balloons separated by deep notches having non-inflatable elements. FR2921822 discloses a gastric ring. This ring includes flexible tabs to prevent slipping relative to the stomach. The ring has an inflatable structure forming several chambers with facets of contact with the stomach. The rooms are separated by bellows. The objects assigned to the present invention therefore seek to overcome the drawbacks listed above and to propose a new implantable surgical ring capable of providing effective and atraumatic tightening of a biological organ, while having a good longevity.

Another object assigned to the invention is to provide a new implantable surgical ring which has a particularly simple structure, lightweight, and inexpensive to manufacture.

Another object assigned to the invention is to propose a new adjustable and versatile implantable surgical ring.

Another object assigned to the invention is to propose a new implantable surgical ring that exhibits a predictable, controllable and reproducible behavior.

Another object assigned to the invention is to provide an implantable surgical ring whose installation is facilitated.

Yet another object assigned to the invention is to provide a new implantable surgical ring that provides a homogeneous clamping of the biological organ.

Finally, another object assigned to the invention is to propose a novel method of manufacturing an implantable surgical ring that makes it possible to obtain, using simple and inexpensive tools, a surgical ring meeting the aforementioned requirements. .

The objects assigned to the invention are achieved by means of an implantable surgical ring intended to be placed around a biological organ constituting a pocket or a conduit in order to modify the passage section of said biological organ, said ring comprising a flexible band which is able to wrap around an axis (X-X ') to form a loop around the body and which has a ventral surface adapted to come into contact with said body, said ring being characterized in that said flexible band is preformed so that the ventral surface is curved about said axis (X-X ') and divided into a plurality of contiguous and intersecting facets which are connected to each other by transition zones forming predefined articulation folds whose angular coverage vis-à-vis the axis (X-X ') is less than or equal to 5 °, preferably less than or equal to 3 °, and so particularly preferably less than or equal to 1 °. Each facet covers an angular sector substantially between 15 ° and 35 °.

The objects assigned to the invention are also achieved by means of a method of manufacturing an implantable surgical ring intended to be placed around a biological organ constituting a pocket or a conduit in order to modify the passage section. of said biological organ, said method comprising a step (a) of producing a flexible band which is able to wind around an axis (X-X ') to form a loop around the organ and which has a ventral surface adapted to come into contact with said body, said method being characterized in that it comprises a step (b) of forming the ventral surface, which comprises a sub-step (b1) of bending preforming during which one confers on the ventral surface a curved shape about said axis (X-X '), and a substep (b2) of division during which a plurality of contiguous and secant facets are formed on said ventral surface which are connected to the one to another by zones transitions forming predefined articulation folds whose angular coverage vis-à-vis the axis (X-X ') is less than or equal to 5 °, preferably less than or equal to 3 °, and particularly preferential less than or equal to 1 °. Each facet covers an angular sector substantially between 15 ° and 35 °.

Other characteristic objects and advantages of the present invention will appear in more detail on reading the description which follows, and with the aid of the accompanying drawings, provided for purely illustrative and non-limiting purposes, among which: FIG. 1 represents, in a perspective view, an implantable surgical ring according to the invention in open configuration.

FIG. 2 illustrates, in a side view, the surgical ring of FIG. 1.

FIG. 3 illustrates, in a cutaway perspective view of material at the sagittal plane, an alternative embodiment of a ring such as that shown in FIGS. 1 and 2.

FIG. 4 illustrates, in a view similar to that of FIG. 3, another variant embodiment of a surgical ring according to the invention.

FIG. 5 illustrates, in a view in transverse section, a portion of a ring conforming to that shown in FIG. 3. FIG. 6 illustrates, in a view similar to that of FIGS. 3 and 4, a third variant embodiment of a surgical ring according to the invention.

7 illustrates, in a perspective view, a fourth embodiment of surgical ring according to the invention, in closed configuration.

The present invention generally relates to an implantable surgical ring 1 intended to be placed around a biological organ (not shown) constituting a pocket or a conduit, in order to modify the passage section of said biological organ.

According to an alternative embodiment, said ring 1 can be arranged to form a sphincter for the regulation of blood flow or the treatment of urinary or faecal incontinence.

However, preferably, the ring 1 is a gastric ring for the treatment of obesity, which is designed to be positioned on the esophagus or on the stomach.

In a particularly preferred manner, the ring 1 is specifically adapted to be placed on the stomach pouch which results from a by-pass surgical operation, in order to oppose the post-operative dilation of said stomach pocket, and thus constitutes a gastric bypass ring.

According to the invention, the ring 1 comprises a flexible band 2 which is able to wrap around an axis (X-X ') to form a loop around the body.

Although it is conceivable, without departing from the scope of the invention, that the flexible band 2 forms a kind of open saddle intended to partially surround the member concerned, for example in the shape of a "U", said flexible band 2 will be preferably sufficiently long to contain substantially the entire perimeter of the biological organ, and in particular to be closed on itself, preferably substantially at its ends 3, 4, so as to form a closed loop surrounding the organ . For this purpose, the flexible strip is preferably provided with locking means 5, 6 designed to maintain it in closed configuration, said locking means comprising for example one or more male elements 5, such as a pin, intended to cooperate, by example snap, with a female element 6 conjugate, such as a sleeve. Advantageously, the locking means 5, 6 are reversible, so that the ring 1 can pass alternately, under the control of the practitioner, an open configuration in which its ends 3, 4 are separated and distant, as this is illustrated for example in Figures 1 and 2, a closed configuration in which its ends 3, 4 are joined and maintained in contact with one another, as shown in Figure 7. Of course, the outline delimited by the ring 1 according to the invention around the biological organ is not limited to a particular form.

However, the ring 1 will preferably be designed to adopt, when in a closed configuration, the shape of a circular loop axis (X-X '). Furthermore, the ring 1 can comprise one or more gripping tabs 7, 8, intended to facilitate the handling of said ring 1, in particular during its implantation and / or to allow the actuation of the locking means 5, 6.

As illustrated in the figures, the flexible band 2 has a ventral surface 10 which is designed to come into contact with said member, so as to grip the latter.

Preferably, the flexible strip 2 is thus delimited by said ventral face 10 inwardly, that is to say closer to the axis (X-X '), and by a dorsal portion 11 externally, as opposed to said ventral surface 10 and in the area furthest from the axis (X-X ').

Preferably, as illustrated in particular in FIG. 5, the dorsal portion 11 is formed by a peripheral belt 12 which is preferably substantially inextensible so as to form a support member whose perimeter is substantially invariant. In addition, the flexible strip 2 preferably has a first lateral wall 14 and a second lateral wall 15 disposed on either side of the ventral surface 10 along the axis (X-X ') and joining said ventral surface 10 to the back portion 11.

Advantageously, the flange marking the transition between the ventral surface 10 and the lateral faces 14, 15 has a rounded and atraumatic contour.

According to a preferred feature of the invention, the flexible strip 2 is preformed so that the ventral surface 10 is curved around the axis (X-X ').

Advantageously, by conferring on the flexible strip 2 a form at rest which has a certain curvature which "primes" the flexion of said flexible band on itself around the axis (X-X '), it is easier to set up of the ring 1 around said member, and in particular its closure by approaching its end 3, 4.

Of course, the initial curvature at rest of said flexible band 2 may be freely chosen by the skilled person during manufacture, and more or less pronounced.

According to an important characteristic of the invention, the ventral surface 10 is divided into a plurality of facets 20, 120, 220, 320 (...) joined and secant which are connected to one another by transition zones 21, 121, 221 (...) which form predefined articulation folds whose angular coverage vis-à-vis the axis (X-X ') is less than or equal to 5 °, preferably less than or equal to at 3 °, and particularly preferably less than or equal to 1 °. Each facet covers an angular sector substantially between 15 ° and 35 °.

"Angular coverage" means the angle e corresponding to the arc formed by a transition zone 21 in a plane P normal to the axis (X-X '), and whose apex is on said axis ( X-X '), as illustrated in FIG.

Advantageously, the arrangement according to the invention makes it possible to discretize the internal contour of the ring 1, at the level of the ventral surface 10, into a longitudinal chain of facets 20, 120, 220, 320 which are successive, preferably located substantially at the same abscissa with respect to the axis (X-X '), and defining at the level of the flexible strip 2 sections which are articulated with respect to each other, at particularly narrow transition zones 21, 121 , that is to say each having, along the perimeter of the flexible strip 2, a particularly narrow or even substantially zero angular coverage e. In a particularly advantageous manner, the arrangement according to the invention thus makes it possible to pre-create preferential folding zones, at the level of the transition zones 21, 121, 221 situated at the interface between the facets 20, 120, 220, 320, and therefore control the location and amplitude of formation of the folds when the ring 1 is set up around the stomach.

As such, the combination of a curved pre-form and a faceted division as claimed makes it possible to optimize the control of the folding zones and to limit the fatigue experienced by the constituent material of the flexible strip 2, and more particularly the ventral side 10. For convenience of description reference will be made to the facets as a whole as well as transition areas as a whole. However, it is perfectly conceivable, without departing from the scope of the invention, that one or the other of the characteristics described can be applied to a facet or a junction zone in particular, or to the majority or the whole of facets and / or transition zones. Of course, some facets and transition areas may have unique characteristics that distinguish them from other facets or transition zones.

Preferably, the transition zones 21, 121, 221 are formed by edges that correspond to the intersection of the contiguous facets, as illustrated in FIGS. 1 to 7.

Preferably, the transition zones 21, 121, 221 are particularly narrow and shallow. Preferably, they will be linear and substantially parallel to the axis (X-X '), resulting directly from the edge-to-edge joining of the two facets which are adjacent to them and which preferably form a sharp angle. In other words, the transition zones are preferably confined to straight-off fillet, straight lines joining the first lateral face 14 to the second lateral face 15 and marking the boundary of separation between the successive facets.

Of course, the number, the shape and the dimensions of the facets 20, 120, 220, 320, as well as transition zones that are interposed between them can be subject to variations without departing from the scope of the invention.

However, the ring 1 according to the invention will preferably comprise at least 4 facets, or at least 6 facets or even 12 facets, as shown in Figures 1 and 2.

Each facet 20, 120, 220, 320 may have a relatively large extent, so as to provide a substantially atraumatic bearing surface and to limit the risk of pinching the wall of the biological organ.

More particularly, each facet will preferably cover an angular sector, measured around the axis (X-X ') and in the plane P, substantially between 15 ° and 35 °.

In addition, the ventral surface 10 will preferably have along its entire length, that is to say between the first end 3 of the flexible strip 2 and the second end 4 of the latter, an uninterrupted succession of facets and zones. transition alternately. Preferably, the distribution of the facets will be regular along the ventral surface 10. More particularly, said facets may be equidistributed and oriented so that their respective mediators converge towards the axis (X-X ') and intersect substantially at the level of said axis.

According to a preferred embodiment, the facets 20, 120, 220, 320 are substantially identical to each other, and in particular can have substantially the same angular coverage, the same longitudinal and transverse dimensions.

Thus, the ventral surface 10 can advantageously form, when the ring is in closed configuration, a regular polyhedron whose faces are preferably substantially parallel to the axis (X-X ').

Such an arrangement advantageously makes it possible to obtain a homogeneous clamping of the biological organ.

Preferably, the facets 20, 120, 220, 320 are mounted radially movable relative to the back portion 1 1 of the flexible band 2. In other words, the ring 1 is advantageously designed to allow the practitioner to adjust the diameter of its light, within which the biological organ passes, by noting the distance to the axis (X-X ') of said facets.

Thus, the surgical ring 1 is advantageously provided with adjustment means which make it possible to adjust the constriction of the biological organ by the flexible band 2, and more particularly the apparent perimeter delimited by the ventral surface 10.

For this purpose, the facets 20, 120, 220, 320 preferably delimit one or more inflatable bag (s) 30, so that they can be driven in radial displacement by elastic deformation and / or by folding / unfolding pneumatically or hydraulically by supplying or removing fluid to or from the ring 1.

In a particularly preferred manner, as illustrated in particular in FIGS. 3, 4 and 6, the facets belong to one and the same inflatable pocket 30, in this case substantially annular, which extends substantially over the entire length of the flexible strip 2, from its first end 3 to its second end 4, and which is segmented transversely by the folds marked by the transition zones.

More particularly, the inflatable bag 30 may be formed by a substantially tubular membrane 31 made of a biocompatible elastomeric material of the silicone type. Advantageously, the inflatable bag 30 is provided with only one wall thickness throughout its section and its entire length.

Preferably, said membrane 31 forms in one piece the ventral surface 10, and in particular the facets as well as the first and the second lateral wall 14, 15, as illustrated in FIG. 5, which contributes to improving its mechanical strength and tightness.

Advantageously, the inflatable bag 30 delimits a cavity 32 which communicates with a tip 33 for supplying or withdrawing fluid into said cavity, for example by means of a catheter connected to a remote fluid reservoir (not shown).

In this respect, it is remarkable that the membrane 31 may advantageously give the succession of facets and transition zones a monobloc and continuous structure, distinct from the back belt 12 and located at a distance from the latter.

The inventors have found that it is possible to obtain an ordered, predictable and reproducible folding of the ring by means of a simple facet discretization of the ventral surface 10, for example by means of a ring such as that shown in FIG. 6. Thus, the marking formed by the folds, and more particularly by the preformed edges on the surface of the ventral surface 10, of the simple fact of the fold construction marking at the level of the membrane 31, is just necessary and sufficient to create a well-localized bending primer that achieves a controlled and reproducible behavior of the ring. However, according to a preferred feature which may constitute an invention as such, the surgical ring 1 is provided with means of 40 which act on the transition zones 21, 121, 221 to oppose their radial displacement when the facets 20, 120, 220, 320 which are adjacent to them are driven in radial displacement.

Indeed, the inventors have been able to establish that the control of the position and uniformity of the folding was improved when elements capable of substantially retaining the transition zones, and more particularly the edges, at a substantially constant distance were provided. of the dorsal portion 11.

More particularly, it is advantageous to provide a member capable of exerting a substantially radial tensile force capable of preventing or at least limiting the centripetal radial displacement of said transition zones with respect to that of the free facets such that this is the case for the variants illustrated in FIGS. 3, 4, 5 and 7 in particular

Preferably, the retaining means 40 comprise for this purpose one or more tie rods 41 which mechanically join the transition zones, and more particularly the edges, to the dorsal portion 11 of the flexible band 2.

Advantageously, these tie rods can be internal or external, that is to say arranged inside the inflatable bag 30, as shown in Figures 3, 4, and 5, or outside of said pocket 30, as shown in Figure 7. In either case, they are preferably arranged to allow the free circulation of fluid inside the inflatable bag 30, on both sides. other edges, that is to say in the different sections delimited between said edges and corresponding to the facets.

The tie rods 41 may be formed by elements having a higher intrinsic rigidity than that of the membrane 31, and in particular by tongues integrally formed with the back belt 12, as illustrated in FIG. 7, or by thicknesses of material, ribs type, preferably integral with the membrane 31.

According to a preferred embodiment, each edge comprises at least two paired tie rods 41 which each extend on a lateral face 14, 15 of the flexible strip 2, on either side of the edge, as illustrated. in Figures 5 and 7.

The tie rods 41 may in particular be in the form of plates forming ribs which may be arranged either radially, ie substantially perpendicularly to the dorsal portion 11 and to the ventral surface

10, as shown in Figure 4, or obliquely, as shown in Figure 3.

As such, according to a preferred embodiment illustrated in said Figure 3, the tie rods 41 can be arranged in pairs so as to form triangular structures, each edge being "guyed" by means of two pairs of tie rods 41 forming a triangle whose base is fixed to the dorsal portion 11 and whose apex coincides with the edge.

Furthermore, according to a preferred characteristic which may constitute an invention as such, the facets 20, 120, 220, 320 are substantially planar when the surgical ring is at rest, that is to say in particular when the pocket 30 is not deformed under the constraint of a fluid under pressure.

Thus, the resting contour of the ventral surface 10, considered in the plane P will preferably be substantially in the form of a broken polygonal line, and more particularly of a regular polygon when the ring is in closed configuration. In other words, the ventral surface 10 preferably draws, in projection in the plane P, a regular polygon writable in a circle centered on the axis (X-X '), the vertices of which are formed by the projections of the ridges and whose sides, corresponding to the strings which connect the vertices located on said circle between them, are formed by the projections of the facets.

Advantageously, this particularly compact arrangement, in which each facet is substantially in line with the previous one, facilitates the introduction of the ring around the organ, in particular when it is necessary to engage it in space. retro-gastric.

In addition, such a geometry, particularly simple, is favorable to the realization of the ring 1 by molding.

Of course, the facets may also adopt a curved geometry, and in particular deform during inflation to form domes, as shown in dashed lines in Figure 2.

As such, it is remarkable that the geometric and dimensional characteristics, in particular the angular covers, as well as the proportions specified in the foregoing are preferably measured when the ring is closed and at rest, but that they can advantageously be substantially preserved, or at least evolve within specified ranges, during configuration changes caused by inflation or deflation of the ring.

Furthermore, it is remarkable that the contour formed by the ventral surface 10, although concave with respect to the axis (X-X '), is advantageously devoid of recesses or recesses, especially at the level of transition zones.

Preferably, the thickness of the membrane 31 is substantially constant over the entire extent of the ventral surface 10, and in particular over the entire length of the flexible strip, in particular at the passage of the transition zones between two successive facets.

This contributes in particular to simplify the molding of said membrane. Of course, the present invention is not limited to a particular embodiment variant.

In particular, it is perfectly conceivable that the ring 1 according to the invention comprises a plurality of inflatable pockets, in particular annular, staggered along the axis (X-X '), or that the inflatable pocket or pockets have a structure bidirectional facets, that is to say a matrix structure divided into facets both in the direction of its length, that is to say its perimeter about the axis (X-X '), that in the sense its height measured in a direction parallel to said axis (X-X '). The present invention also relates to a method of manufacturing a surgical ring 1 having one or other of the features described above.

Thus said method preferably comprises a step (a) of producing a flexible band 2 which is able to wind around an axis (X-X ') to form a loop around the body and which has a ventral side 10 adapted to come into contact with said member, said method also comprising a step (b) of forming the ventral surface 10, said step (b) of forming the ventral side comprising a substep (b1) preforming bending, during which the ventral surface is given a curved shape about said axis (X-X '), and a divisional sub-step (b2) during which a plurality of facets 20 are formed on said ventral surface 20 , 120, 220, 320 joined and secant which are connected to one another by transition zones 21, 121, 221 forming predefined articulation folds whose angular coverage vis-à-vis the axis ( X-X ') is less than or equal to 5 °, preferably less than or equal to 3 ° and of is particularly preferably less than or equal to 10.

Preferably, the sub-step (b1) of preforming makes it possible to impart to the flexible strip 2 a pronounced curvature, so that the ring 1 has at rest a profile substantially in "C", which covers spontaneously at least 180 ° at least 225 ° around the axis (XX ').

Preferably, the substep (b2) of division is made by molding in contact with a polyhedral core which has a succession of flat faces corresponding to the negative impressions of the facets.

More particularly, said polyhedral core may be in the form of a polyhedron axis (X-X ') whose side faces will be substantially regular, flat and parallel to said axis (X-X'), and are advantageously inscribed in a circular cylinder with axis (XX ').

Advantageously, the ring 1 according to the invention can therefore be produced by means of a particularly simple tool to machine, and therefore inexpensive, and poses no problem of demolding, which simplifies its manufacture and limits the scrap rate. . The operation of a surgical ring 1 according to the invention will now be described in more detail.

The practitioner first introduces a surgical ring under the skin after making an incision. To do this he can proceed by laparoscopy and introduce the ring 1 through a cannula.

For this purpose, the practitioner may advantageously straighten the flexible band 2 by using its intrinsic elasticity, to temporarily give it a substantially rectilinear shape. When the ring 1 is in the body, it tends to find spontaneously, by shape memory, its curved shape.

The practitioner can then engage around the organ, then bring the ends 3, 4 closer to each other until they touch each other, so as to form a closed loop around said organ. The engagement of the locking means 5, 6 keeps the ring in closed configuration.

When it brings the ends 3, 4 of the flexible band 2 closer to one another, the practitioner forces the bending of said flexible band 2, which has the effect of further marking the folds formed by the edges and consequently to gradually close the angle formed between the consecutive facets. Advantageously, the folds thus formed are spontaneously localized, in a substantially uniform angular distribution, at the level of the transition zones which form bending deformation primers.

Once the ring is in place, the facets come into contact with the wall of the biological organ. The practitioner can then introduce a fluid under pressure into the inflatable bag 30, and thus cause the deformation of the facets 20, 120, 220, 320.

More particularly, it bombs said facets, that is to say the free intermediate zones that are between the edges so that said facets form domes that swell in a centripetal radial direction by gradually tightening the biological organ.

Advantageously, during this inflation operation, the tie rods 41 hold the recessed edges of the facets, thereby accentuating the folds formed between two adjacent facets, and limiting the centripetal elastic deformation substantially only to the facets, and more particularly to the central zone of each facet located equidistant from the two edges which delimit the latter.

Thus, one precisely controls the deformation zones of the ring 1, as well as the overall diameter of the light of said ring through which the biological organ passes. If the practitioner wishes to release the embrace exerted by the ring on the biological organ, or even extract the ring, it can proceed to a puncture of fluid in the pocket 30 so as to deflate it.

The domes formed at the level of the facets then tend to collapse by elastic return, so that the ventral surface 10 gradually regains its structure at rest, with substantially flat facets.

If necessary, the practitioner can unlock the ring to open the loop, for example with the help of the gripping tabs 7, 8.

Thus, the ring 1 according to the invention provides a clamping adaptable, atraumatic, and respectful of the physical integrity of the ring, since it limits the fatigue work of the membrane 31, distributing in a manner balanced, predictable and controlled folds along the ventral side 10.

In particular, the use of facets 20, 120, 220, 320 and advantageously retaining means 40 makes it possible to maintain a uniform and circular shape of clamping capable of preventing the appearance of pinching zones and / or pressure points. traumatic for biological tissues.

In addition, such a ring has a particularly simple structure whose manufacturing cost is relatively modest. Finally, it is remarkable that, whatever the number of opening or closing cycles of said ring 1, or inflation / deflation thereof, its behavior is controlled and reproducible, both at the position, the orientation, or the intensity of the folds formed, than the dilation or contraction of the facets.

Claims

1. Implantable surgical ring (1) intended to be placed around a biological organ constituting a pocket or a conduit in order to modify the passage section of said biological organ, said ring comprising a flexible band (2) which is able to be wound around an axis (X-X ') to form a loop around the member and having a ventral surface (10) adapted to engage said member, said ring being characterized when said flexible band (2) is preformed such that the ventral surface is curved about said axis (X-X ') and divided into a plurality of contiguous and intersecting facets (20, 120, 220, 320) which are connected to each other by zones transition (21, 121, 221) forming predefined articulation folds whose angular coverage vis-à-vis the axis (X-X ') is less than or equal to 5 °, preferably less than or equal to 3 ° and particularly preferably less than or equal to 1 °, each e facet (20, 120, 220, 320) covering an angular sector substantially between 15 ° and 35 °.

2. Surgical ring according to claim 1 characterized in that the transition zones (21, 121, 221) are formed by edges corresponding to the intersection of the contiguous facets.

3. Surgical ring according to claim 1 or 2 characterized in that the facets (20, 120, 220 320) define one or more inflatable pockets (30).

4. Surgical ring according to one of the preceding claims characterized in that the facets (20, 120, 220, 320) are mounted radially movable relative to the dorsal portion (1 1) of the flexible band (2).

5. Surgical ring according to claim 4 characterized in that it is provided with retaining means (40) acting on the transition zones (21, 121, 221) in order to oppose their radial displacement when the facets which their are adjacent are driven in radial displacement.

6. Surgical ring according to claims 2 and 5 characterized in that the retaining means (40) comprise one or more tie rods (41) which join the edges to the dorsal portion (1 1) of the flexible band (2).

7. surgical ring according to claim 6 characterized in that each edge comprises at least two tie rods (41) which each extend on a side face of the flexible strip, on either side of the edge.

8. Surgical ring according to one of the preceding claims characterized in that, when at rest, the facets are substantially planar.

9. Surgical ring according to one of the preceding claims characterized in that the facets (20, 120, 220, 320) are substantially identical to each other.

10. Surgical ring according to one of the preceding claims characterized in that it constitutes a gastric bypass ring.

1 1. A method of manufacturing an implantable surgical ring (1) intended to be placed around a biological organ constituting a pocket or a conduit in order to modify the passage section of said biological organ, said method comprising a step (a) of realization a flexible band (2) which is able to wind around an axis (XX ') to form a loop around the body and which has a ventral surface (10) designed to come into contact with said body, said method being characterized in that it comprises a step (b) of forming the ventral surface, which comprises a flexural preform sub-step (b1) during which the ventral side is given a curved shape around said axis (XX '), and a division sub-step (b2) during which a plurality of contiguous and intersecting facets are formed on said ventral surface which are connected to one another by transition zones forming predefined articulation folds do nt the angular coverage with respect to the axis (XX) is less than or equal to 5 °, preferably less than or equal to 3 °, and particularly preferably less than or equal to 1 °, each facet (20, 120, 220, 320) covering a substantially angular sector between 15 ° and 35 °.

12. The method of claim 11 characterized in that the sub-step (b2) of division is made by molding in contact with a polyhedral core having a succession of flat faces corresponding to the fingerprints of the facets.