EP2273954A2

EP2273954A2 - Gastric ring with membranous bridge

Info

Publication number: EP2273954A2
Application number: EP09742317A
Authority: EP
Inventors: Jean-Paul Gilbert Ricol
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: 2008-04-14
Filing date: 2009-04-10
Publication date: 2011-01-19
Also published as: FR2929838B1; WO2009136119A3; RU2010146190A; BRPI0911657A2; FR2929838A1; WO2009136119A2; US20110034761A1

Abstract

The invention relates to an implantable surgical ring (1) intended to close on itself around a mean extension axis in order to enable adjustment of the section through which a biological organ passes, said ring being characterized in that the same comprises at least one first and one second gripping bag (10, 11) that are tiered along the mean extension axis, are designed to be filled with filling fluid, and respectively have a first peak portion (12) and a second peak portion (13), and in that said first and second peak portions (12, 13) are separated by a separation area (14) including a retaining means (20) receding away from said first and second peak portions (12, 13) to limit the depth (P) to which the gripped biological organ can enter between said first and second peak portion.

Description

GASTRIC RING WITH MEMBRANE BRIDGE

TECHNICAL AREA

The present invention relates to the general technical field of surgical implants intended to be implanted in the body of a patient around organ (s) bioiogic (s) constituting a pocket or a conduit, and more particularly to the gastric rings intended to form a closed loop around the stomach to reduce the diameter of the stoma opening.

The present invention more particularly relates to an implantable surgical ring intended to be closed on itself to form a closed loop around a biological organ constituting a pocket or a conduit in order to modify the passage section of said biological organ.

PRIOR ART

It is known to perform surgeries on patients with severe obesity who, because of their overweight, are exposed not only to physical discomfort, but also to a psychological burden and related diseases, such as diabetes, cardiovascular diseases, or severe arthritis.

In particular, a known technique is to perform a gastric constriction to reduce the size of the stomach and therefore the intake of food.

For this purpose, it is frequently used to use gastroplasty rings implanted around the patient's stomach in order to reduce its volume as well as the diameter of its passage (stoma). In a well known manner, such gastroplasty rings generally comprise a flexible band, made of elastomeric material, and intended to be closed at its two ends by appropriate closing means in order to grip the stomach.

In addition, the known rings generally comprise an annular compression chamber located on the inner face of the flexible strip and whose volume is adjustable by adding or removing a filling fluid.

Thus, it is possible, from a ring of fixed overall dimensions, to finely adjust the inner diameter of said ring by a radial expansion or retraction of the chamber.

Such implantable rings generally give satisfaction, but nevertheless suffer from a number of disadvantages, in particular due to certain uncontrolled changes in their position during the treatment period.

Indeed, it turns out that the rings of the prior art are sometimes subject to displacements caused by natural movements of dilation and contraction of the stomach.

In some cases, these movements may even lead to the expulsion of the ring by sliding or even to its turn on itself, so that it becomes inoperative on the therapeutic y and constitutes an inconvenience for the patient

In such a situation, it is then necessary to carry out a new surgical procedure for the replacement or repositioning of accidentally displaced Panel. Of course, the reiteration of such corrective surgical operations unnecessarily mobilizes medical personnel, causes additional inconvenience to the patient, or even exposes the latter to post-operative complications.

Furthermore, the rings of the prior art are sometimes capable of causing changes in the stomach wall, such as abrasion lesions or even necrosis by pinching, in particular when the ring is incorrectly positioned and / or the compression chamber has material beads or folds which locally trap said stomach wall.

SUMMARY OF THE INVENTION

The objects assigned to the present invention therefore aim to remedy the aforementioned drawbacks and to propose a new implantable surgical ring, in particular gastric, which has a high stability while being particularly respectful of the integrity of the living tissues on which it acts.

Another object assigned to the present invention is to provide a new implantable surgical ring which has a simple, compact, lightweight and robust structure.

Another object assigned to the invention is to propose a new surgical ring which is particularly comfortable and which has a good ability to adapt to different conditions of use.

The objects assigned to the invention are achieved by means of an implantable surgical ring intended to be closed on itself to form a closed loop around an average axis of extension (XX ") so as to be able to grip a organ biological composition constituting a pocket or conduit for modifying the passage section of said biological organ, said ring being characterized in thatii comprises at least a first clamping pocket and a second clamping pocket which are stepped relative to each other; at the other along the mean extension axis (X-X ') and adapted to be filled with a filling fluid so as to be able to clamp the biological organ, said first and second clamping pockets respectively having a first ridge portion and a second ridge portion which project inwardly of the loop to abut against said biological member, and in that said first and second ridge portions are separated from one another other by a separation zone which defines an empty clearance zone of sufficiently marked material to ensure a discontinuity of contact between the biological organ and the surgical ring, between the pores and a retaining means disposed away from the first and second ridge portions and adapted to limit the depth to which the constricted biological member is able to penetrate between said first and second ridge portions, so as to avoid alteration of the wall of the biological organ in the separation zone.

SUMMARY DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the invention will appear in more detail on reading the description which follows, as well as with the aid of the accompanying drawings, provided for purely illustrative and non-limiting purposes, among which:

- Figure 1 shows, in a perspective view, a surgical ring according to the invention in its closed configuration.

FIG. 2 illustrates, in a cutaway perspective view of material, a portion of the surgical ring shown in FIG. - Figure 3 illustrates, in a schematic longitudinal sectional view, a surgical ring according to the invention placed in a closed configuration around a biological organ to enclose the latter.

- Figures 4A, 4B and 4C illustrate, in partial schematic longitudinal sectional views, different embodiments of surgical rings according to the invention.

BEST MODE OF REALIZING THE INVENTION

The present invention relates to an impiantable surgical ring 1 which is intended to be closed on itself to form a close loop 2 around a mean axis of extension (X-X ') in order to be able to grip a biological organ 3 which constitutes a pocket or a duct, for modifying the passage section of said biological organ 3.

In other words, the loop 2 is geometrically wound around a mean axis of extension (X-X '), which advantageously coincides, after implantation, with the direction of extension of the duct or pocket formed by the biological organ 3, as shown in FIG.

In the description which follows, reference will be made, by way of example and for convenience of description, to a gastroplasty ring, or gastric ring, designed to be implanted around the stomach in order to reduce the diameter of the opening. stoma, or designed to be implanted around the esophagus.

However, the invention is in no way limited to this application, and also generally covers surgical rings intended to be implanted in the body of a patient around any biological organ constituting a pocket or a conduit for the purpose of modify the passage section of said biological organ 3 when said ring is disposed around the latter.

Thus, the present invention can be adapted for the treatment of urinary or faecal incontinence, or for the regulation of blood flow.

Depending on its purpose, the surgical ring will of course be adapted to the dimensions, the environment and the sensitivity of the biological organ 3 concerned by the constriction, such as bladder, urethra, intestine, arteries, veins, etc.

Preferably, the surgical ring 1 is sufficiently flexible to move from an open configuration (not shown) to a closed configuration illustrated in particular in Figures 1 and 3, wherein said ring is closed substantially to its two ends 4, 5 to by means of appropriate closing means 6, 7 so as to form the above-mentioned dose loop 2.

Thus, by trapping the biological organ 3 inside the loop 2, it is possible to narrow the diameter of its passage section, and, in the particular case of the stomach, the opening of the stoma.

Of course, the geometry adopted by the closed loop 2 is not limited, but the latter will preferably have a substantially rounded contour, and particularly preferably substantially circular.

More generally, the surgical ring 1 according to the invention will preferably have, when in the closed configuration, substantially a geometry of axis revolution (X-X '). Advantageously, the closing means 6, 7 are designed to cooperate with each other to ensure the locking of the ring 1 in its closed configuration.

By way of example, it will be possible to use for this purpose a sleeve 6 fixed on the first end 4 of the ring 1 and intended to receive a rod 7 associated with the second end 5, said rod 7 preferably comprising one or more lugs 7A so as to allow a snap type assembly with the sleeve 6.

According to an important characteristic of the invention, the surgical ring 1 comprises at least a first clamping pocket 10 and a second clamping pocket 11 which are staggered with respect to each other along the mean axis of the invention. extension (X-X ') and which are designed to be filled by a filling fluid so as to ensure the clamping of the biological member 3.

For this purpose, the first clamping pocket 10 has a first crest portion 12 and the second clamping pocket 11 has a second crest portion 13 respectively, said first and second crest portions protruding inwardly of the loop 2 to come in support against the biological organ 3 =

According to another important feature of the invention, said first and second peak portions 12, 13 are separated from one another by a separation zone 14.

Advantageously, this separation zone 14 gives the ring 1 a particularly stable character once it is implanted. Indeed, said separation zone makes it possible to separate, in normal operation, the first contact zone 16 at which the first crest portion 12 comes into contact with the biological organ 3, the second contact zone 17 at the of which the second crest portion 13 bears against said biological organ 3.

Thus, by maintaining two substantially disjointed contact areas 16, 17 at a distance from one another, the separation zone 14 ensures a discontinuity of the anchoring of the ring 1 on the member 3, which improves significantly the stability of said ring to the extent that, even if said ring comes to lose momentarily taken at the first anchor point provided by the first clamping pocket 10, there remains the second anchor point that provides him the second clamping pocket 11 to retain it, and vice versa.

In other words, the separation of the clamping means makes it possible to multiply the retaining points of the ring 1 to the member 3, and thus to considerably reduce the probability that the kinematic conditions of a displacement of said ring with respect to said ring biological organ are united at the same time.

Consequently, the phenomena of displacement or even accidental release of the ring are substantially limited.

Within the meaning of the invention, the first clamping pocket 10 and the second clamping pocket 11 may be partitioned and separated from one another in a sealed manner, or conversely communicate with each other and form the two projecting portions of the same room.

According to such an embodiment variant, the chamber forming a common container for the filling fluid has two protuberances distinct and distant which constitute the first and second crest portions 12, 13 and are intended to come each in contact with the biological organ 3, respectively at the level of the first contact zone 16 and the second contact zone 17.

In addition, particularly preferably, each clamping pocket 10, 11, and more particularly each of the first and second crest portions 12, 13, has a substantially annular shape and extends substantially over the entire perimeter of the loop. 2.

Thus, the surgical ring 1 according to the invention preferably comprises two annular clamping pockets superimposed axially and spaced apart from each other, each being capable of ensuring the constriction of a distinct portion of the organ 3, occurs at a first and a second contact area 16, 17 at different abscissae along said extension axis (X-X ') and having a substantially circular contour centered on said extension axis (X-X '),

Such staging of the ridge portions, and more generally clamping pockets as a whole, advantageously makes it possible to ensure a firm and secure grip of the ring on the biological organ 3, and in particular to maintain said ring in place during of peristaltic movements of said biological organ 3.

In order to mark the transition between the first and second clamping pockets 10, 11, and more particularly between the first crest portion 12 and the second crest portion 13, the separation zone 14 preferably defines an empty clearance zone of a material which forms a depression 18 marked in hollow with respect to said portions of peaks 12, 13 and which opens on the inside of the loop 2. More particularly, the bottom of said depression 18 can substantially follow a circular contour around Taxe (X-X '), whose diameter is greater than that of the contour formed by circular ridges corresponding to the first and second pockets of serragelO, 11.

Thus, once the ring is implanted, the separation zone 14 advantageously faces the wall of the biological organ 3 and forms a mechanical isolation boundary between the first contact zone 16 and the second contact zone 17. that is to say an area in which the contact between the outer surface of the biological organ 3 and the inner surface of the ring 1 is normally interrupted, at least in places, so that said surgical ring 1 has a independent behavior in each of said contact areas 16, 17.

In particular, it is advantageously avoided that a sliding of the ring 1 by breaking the contact in the first contact zone 16 does not cause an overall sliding of the ring, by continuous extension of the conditions of occurrence of said dynamic sliding phenomenon. at the second contact zone 17.

By analogy, the structure of the surgical ring 1 according to the invention is similar to that of a catamaran, whose floats correspond to the clamping pockets 10, 11 which provide mainly simultaneously, and very occasionally individually, the contact with the surface of the biological organ 3.

Of course, the arrangement and the shape of the first and second clamping pockets 10, 11, which substantially define by construction the geometry of the first and second contact areas 16, 17, are not limited to an embodiment variant. special. Due to the presence and conformation of the separation zone 14 according to the invention, the wall of the biological organ 3 is likely, when the ring 1 is implanted, to struggle in the space thus provided. between the crest portions 12, 13, and in particular to creep between the first and second clamping pockets 10, 11. Under certain conditions, for example tors of the passage of food in the case of the stomach, the wall of the organ may temporarily tend to engage with a certain force of penetration in the separation zone 14, and to sink in depth.

Therefore, according to another important feature of the invention, the separation zone 14 comprises a retaining means 20 which is set back from the first and second ridge portions 12, 13 and which is designed to limit the depth P to which the constricted biological organ 3 is capable of penetrating between said first and second crest portions 12, 13, so as to avoid the alteration of the wall of the biological organ 3 in the separation zone 14.

Thus, if the separation zone 14 is sufficiently marked to ensure, in normal operation of the device, a certain discontinuity of contact between the biological organ 3 and the surgical ring 1, between the crest portions 12, 13, it is however provided with a retaining means 20 which prevents said biological organ 3 from penetrating, even temporarily or accidentally, too deeply between the clamping pockets 10, 11, and which advantageously limits for this purpose the free space provided to allow free radial displacement of the wall of the organ.

Indeed, excessive penetration would lead to the formation of a marked fold of the wall of the biological organ and would constitute a risk of progressive deterioration of the tissues of said biological organ 3 by pinching, abrasion, or necrosis. Advantageously, the retaining means 20 thus forms a stop against the progression of the biological organ 3 between the structures of the ring, in the separation zone 14, when said organ tends to locally follow an expansion movement. substantially radial and oriented towards the outside of the loop 2.

In this case, the penetration limit defined by the retaining means 20 is at a depth P with respect to the crest portions 12, 13.

Geometrically, when the loop 2 is substantially circular, the depth P can be considered as the difference between the base radius of a first imaginary cylinder C1 of axis (X-X ') and inscribed in the mud, that is, that is tangent to the first and second crest portions, and the base radius of a second imaginary second cylinder C2 of the same axis (X-X ') and tangential to the face of the retaining means 20 furthest from the axis (X-X '), that is to say, more particularly tangent to the bottom of the depression 18, as shown in FIG.

More particularly, the retaining means 20 is arranged with respect to the clamping pockets 10, 11 such that the radius of curvature of the wall of the biological organ 3, even assuming that said wall comes into contact with the surface of the body. its support, is permanently maintained at a value substantially greater than or equal to a critical value below which there is a risk of abrasion or necrosis of said wall.

In other words, the retaining means 20, and more generally the separation zone 14, are arranged to ensure a certain continuity of the profi! of the wall of the biological organ 3, which prevents the formation of marked folds or settlements, for the sake of preserving said biological wall in and in the vicinity of said separation zone 14, in particular within the depression 18, and more generally throughout the space between the crest portions 12, 13.

Thus, while advantageously maintaining the robustness and stability of an anchor comprising at least two independent support points, the surgical ring 1 according to the invention is particularly atraumatic since it avoids any bruising of the biological organ bound to the implementation of its particular clamping structure.

According to an alternative embodiment, the retaining means 20 can be separated from the first and / or the second clamping bag 10, 11, and in particular be separated from the walls delimiting said clamping pockets, as illustrated on Figure 4B.

In particular, the retaining means 20 may be formed by a crenellated structure or a flange occupying the space between the clamping pockets 10, 11, culminating behind the crest portions 12, 13, and separated from the walls of the pockets. tightening 10, 11 adjacent by residual interstices too narrow to allow the penetration of the wall of the biological organ 3.

However, the retaining means 20 preferably connects the first clamping pocket 10 to the second clamping pocket 11. that this is illustrated in particular in Figures 1 to 3, 4A and 4C.

Thus, the retaining means 20 may form a means of continuous junction between said clamping pockets 10, 11 and create a direct mechanical link between them. In a particularly preferred manner, the retaining element 20 is integral with the first clamping pocket 10 and / or with the second clamping pocket 11.

Advantageously, such a structural unit of the ring 1 gives the latter a particularly robust structure, compact, lightweight, and simple to manufacture, especially in the case of particularly simplified embodiments such as those illustrated in Figures 4A and 4C.

In addition, the surgical ring 1 according to the invention preferably comprises a back belt 21 which supports the first and second clamping pockets 10, 11.

Of course, said backbone 21 will be sufficiently flexible to allow the opening and closing of the ring, and to be able to wind on itself so as to form the loop 2, and at the same time sufficiently resistant to deformation , and in particular traction, to serve as a stable point of support for the clamping pockets 10, 11.

Preferably, once the ring is locked by means of its closure means 6, 7, the backbone 21 is sufficiently inextensible to define a substantially constant perimeter, regardless of the stresses exerted by the biological organ 3 on the clamping pockets 10, 11, so that it provides a radial support to the latter.

As illustrated in FIGS. 2, 3 or 4B, the backbone 21 may be in the form of a substantially rectangular section strip on the inner face of which are fixed said first and second clamping pockets 10, 11 . Advantageously, the surgical ring 1 according to the invention can be arranged in such a way that the first and / or the second clamping pocket 10, 11 have a deformable structure capable of authorizing the collapse of the first crest portion 12 , and / or respectively of the second crest portion 13, towards the outside of the loop 2, under the constraint of expansion of the biological organ 3.

In particular, the first and / or second clamping pocket 10, 11 may for this purpose be made of a flexible material, and in particular a biocompatible polymer such as silicone.

Thus, when the first and second clamping pockets 10, 11 are filled below their nominal volume and / or below their nominal pressure, they have a certain flexibility and can therefore be deformed, and in particular crash, in response to the constraint exerted on them the biological organ 3 when it tends to expand, especially during natural peristaltic movements associated with digestion.

In other words, the first and second clamping pockets 10, 11 preferably have a functional flexibility which can possibly be controlled by the filling conditions of said pockets.

By "nominal inflation volume" is meant the amount of fluid that can hold the first clamping pocket 10, respectively the second clamping pocket 11, without the wall that defines it undergoes elastic expansion or distension under i effect of inflation.

In this respect, it is remarkable that the first and the second clamping pockets 10, 11 may, for the purposes of the invention, have either a "semi-rigid" character, that is to say they may be preformed to adopt at rest, even in the absence of inflation fluid, substantially a shape corresponding to the one they occupy when they contain a nominal volume of said inflation fluid, is a "flaccid" character, that is to say that they do not have their own shape nor occupy a particular deployed volume until they are filled by said filling fluid.

Preferably, the retaining means 20 also has a sufficiently deformable structure to substantially accompany the collapse of said first and second ridge portions 12, 13 towards the outside of the bale 2.

In other words, if said retaining means 20 is designed to impede the penetration of the biological organ 3 between said first and second ridge portions 12, 13, it does not form, on the other hand, a point of contact. protruding residual support capable of constraining the wall of the biological organ 3, and more particularly of exerting a constriction of said biological organ 3 more pronounced than that exerted by the crest portions 12, 13 when the latter recede away from the axis (X-X ') under the pressure exerted by said biological organ 3.

Thus, the surgical ring 1 is likely to move from a "tightened" configuration in which the clamping pockets 10, 11 are substantially inflated to their nominal volume and completely straightened towards the inside of the loop, to a "widened" configuration. Wherein said clamping pockets 10, 11, and in particular the first and second crest portions 12, 13 are substantially collapsed, i.e. farther from the axis (X-X ') than tight configuration.

Of course, the passage from the constricted configuration to the enlarged configuration, which can be obtained by underinflation, in particular by purging the filling fluid when it is incompressible (case of physiological saline) or by simple elastic effect when said fluid is compressible (case of a gas), results in an increase in the constriction diameter of the biological organ 3.

Advantageously, the functional flexibility of the retaining means 20 makes it possible to maintain, even in the enlarged configuration, a residual depth of clearance in the separation zone 14, that is to say to maintain a substantially concave profile of the screw ring. with respect to the biological organ 3 between the first and second crest portions 12, 13.

Although the retaining means may have a fully compressible structure, which partially fills the separation zone 14 in a contiguous or interrupted manner, as is illustrated in FIGS. 4A and 4B, the ring 1 according to the invention presents preferably a recess 22 formed on the outer side of the loop 2 relative to the retaining means 20, between the first and second clamping pocket 10, 11 and in line with said retaining means 20, so as to facilitate the collapse of the latter, as illustrated in particular in Figures 2 and 3.

More particularly, said recess 22 corresponds to a compressible cavity delimited by the retaining means 20, the side walls of the first and second clamping pockets 10, 11 situated facing each other on the other hand. other of said retaining means 20, and the back belt 21, as shown in Figures 2 and 3.

Advantageously, such a recess 22 forms a kind of compression-deformable pad, capable of crashing in a centrifugal radial direction, and acts as a damper with a certain radial "reserve of deformation". In addition, the backing belt 21 preferably comprises one or more orifices (not shown) which put the compressible cavity in communication with the outside of the ring, so as to allow the volume variations of said cavity under the effect of the deformations induced by the radial displacements of the crest portions 12, 13 and the retaining means 20.

According to a preferred embodiment, as shown in Figures 2 and 3, the retaining means 20 comprises a bridge provided with an apron 23 which is intended to form abutment against the biological organ 3, said apron 23 being supported by one or more flexible pillars 24 which bear on the back belt 21 and which are designed to allow the collapse of said apron 23 towards the outside of the loop 2.

According to a preferred embodiment, the pillars 24 are merged with the lateral portions of the walls which delimit the first and second clamping pockets 10, 11 and which are opposite each other on the one hand and on the other side. other of the retaining means 20.

Thus, the retaining means 20 may be formed by a bridge whose apron 23 connects the first clamping pocket 10 to the second clamping pocket 11 so that said bridge spans the recess 22. Advantageously, the attachment points of the apron 23 are set back from the corresponding first and second peak portions 12, 13.

Preferably, the bridge thus operates a junction between the first and second clamping pockets over the entire length of said pockets, that is to say substantially over the entire perimeter of the loop 2. Whatever the embodiment variant considered, the retaining means 20 is preferably made of a biocompatible elastomeric material, such as silicone.

In particular, it will be possible to use a silicone membrane of Shore hardness substantially equal to 30, and having a thickness substantially between 0.5 and 0.6 mm to make the deck 23.

Advantageously, said membrane can be integral with the wall of one and / or the other of the clamping pockets 10, 11, which simplifies the manufacture of the ring and improves the robustness of the assembly.

Moreover, the retaining means 20 is preferably arranged such that, when the first clamping bag 10 is filled with filling fluid, and more particularly contains a quantity of fluid corresponding to its nominal filling volume, the occupied volume by iedit filling fluid within said first filling bag extends, in a direction transverse to Taxe (X-X '), on either side of the retaining means 20, and more precisely on the part and the other of the radial penetration limit that the retaining means 20 defines against the biological organ 3.

In other words, the second dummy cylinder C2 geometrically divides the first cavity 30 delimited by the first clamping pocket 10 in two

"Sub-cavities" 30A, 30B both containing filler fluid, in this case an upper sub-cavity 30A which extends between the first crest portion 12 and the retaining means 20, and a lower sub-cavity 3OB extending between the retaining means 20 and the back belt 21 of the ring. Advantageously, the ring 1 according to the invention therefore has a double radial system of suspension and hydraulic damping, and / or pneumatic, both above and below the bridge, which gives it excellent functional flexibility both at the level of the peak portions 12, 13 and at the level of the retaining means 20.

Within the meaning of the invention, the first cavity 30 intended to contain the filling fluid preferably extends between a bottom wall 30F facing outwardly of the loop 2 and a crest wall 30C oriented towards the inside of the the loop and located at a distance hi from said bottom wall 30F.

Thus, the first cavity 30 has a useful height hi measured between said bottom wall 30F and the crest wall 3OC.

Preferably, the bottom wall 30F is located near the back belt 21, while the crest wall 30C is immediately below the crest portion 12 and forms the surface of the membrane which defines the first clamping pocket 10 in said first ridge portion 12.

Preferably, the retaining means 20 is located at a level between 40% and 60% of said useful height II ₁ relative to the peak wall 30C, in particular when the first cavity 30 is filled to its nominal volume.

Of course, all the construction arrangements relating to the first clamping pocket 10 and the first cavity 30 preferably apply mutatis mutandis to the second cavity 31 delimited by the second clamping pocket 11.

In a particularly preferred manner, the first and the second clamping pocket are sensibly images of each other vis-à-vis a middle yaw of symmetry normal to the axis (X-X ') and cutting the ring, and in particular the retaining means 20 and / or the back belt 21, in the middle.

Furthermore, the retaining means 20, the first clamping pocket 10 and the second clamping pocket 11 are preferably arranged such that they delimit, between the first and second crest portions 12, 13, a depression 18 of which the ratio R1 of the width at mid-depth D1 by the depth P is greater than or equal to 0.5 (ie 50%), and preferably substantially between 0.5 and 1 (ie between 50% and 100%).

In other words, we have:

0.5 <R1 = - <1

where P represents the maximum depth of penetration of the biological organ 3 as it is limited by the retaining means 20, when the clamping pockets are filled to their nominal volume and under normal operating conditions, and where D1 represents the width of the separation zone 14, that is to say the distance between the side walls of said clamping pockets 10, 11 measured at the respective intersections of said clamping pockets with a third imaginary axis cylinder (XX ¹ ) and radius equal to the half-sum of the radii of the first and second dummy cylinders C1, C2, as shown in Figures 3, 4A, 4B and 4C.

According to a preferred embodiment, the width at mid-depth of said depression corresponds substantially to the width of the recess 22 formed under the bridge forming the retaining means 20.

Moreover, the aforementioned depression preferably has a ratio R2 of its width D2 with a maximum penetration depth P said maximum penetration depth P greater than or equal to 0.35, and preferably substantially between 0.35 and 1, that is to say:

0.35 <R2 = - <1

Preferably, the width D2 with a maximum depth of penetration corresponds substantially to the minimum distance separating the first clamping pocket 1 from the second clamping pocket 2 at the bearing surface of the retaining means 20; ie at the bottom (in this case substantially flat) of the depression 18 accessible to the biological organ 3.

In addition, the ratio R1 is preferably greater than the ratio R2, that is to say that the depression 18 of the separation zone 14 is concave and flared with respect to the inside of the loop 2.

Advantageously, the dimensioning of said depression 18 also makes it possible to guarantee the mechanical discontinuity during normal operation of the first and second contact zones 16, 17, and thus to improve the mechanical strength of the ring on the biological organ 3, while avoiding the pinching of the wall of said biological organ 3 in a separation zone which would be too narrow.

Preferably, the aforementioned proportions R1, R2 of the vacuum 18 correspond to the values considered in the nominal operating situation of the ring 1. If need be, they preferably remain within the indicated ranges whatever the functional inflation level. clamping pockets 10, 11. Thus, the implantable ring 1 according to the invention makes it possible to achieve a constriction that is both safe, comfortable and atraumatic for the biological organ 3 to be clamped.

Of course, it is conceivable to adapt a retaining means according to one or the other of the variants described above to a surgical ring whose clamping pockets are not, or not only, staggered along the axis of said ring, but would be located substantially at the same abscissa along the axis (X-X ') so as to each cover a predetermined angular sector about said axis (X-X') thereby forming angular subdivisions of a same crown.

According to such an alternative embodiment, the separation zone 14 could comprise a trench whose walls extend substantially in pans parallel to the axis (X-X ').

The operation of an embodiment of gastric ring 1 according to the invention will now be briefly described with reference to FIG.

The ring is first introduced as unwound (or twisted) preferably by endoscopy.

I! is then passed around the stomach 3 and then closed on itself and locked with the closing means 6, 7 so as to form a closed loop 2.

The practitioner then introduces a predetermined quantity of filling fluid into the first and second clamping pockets 10, 11, so that the first and second crest portions 12, 13 respectively support or reinforce their support against the stomach 3 into two zones of contact 16, 17 disjoint, separated by the intermediate separation zone 14.

Advantageously, the filling of the annular clamping pockets 10, 11 makes it possible to exert against the stomach 3 an adjustable centripetal radial pressure, substantially regular and distributed over the entire circular periphery of each contact zone 16, 17; which allows a fine and personalized adjustment of the constriction of said stomach 3.

Once the implanted ring, and in the absence of movement of the stomach 3, particularly when it is contracted, the intermediate portion of its wall between the first and the second contact area 16, 17 freely floats in the space provided at the separation zone 14.

Advantageously, not only is thus avoided any deterioration of the tissue due to friction of said intermediate portion against the ring 1, but it also provides a particularly stable double anchoring of said ring.

When the stomach 3 tends to expand radially, for example during the absorption of food, its expansion forces its wall to creep between the clamping pockets 10, 11, sinking deeper into the zone. separation 14.

However, this movement of penetration is limited by the retaining means 20 which stops the centrifugal radial progression of the stomach wall when the latter and abuts against it, that is to say when it reaches the maximum depth of penetration P predetermined, as shown in Figure 3.

Thus, even if the stomach wall, under the pressure of the contents of the stomach which has the plate against the inside of the ring, comes temporarily to marry substantially the concave outline of the depression 18, said stomach wall locally retains a radius of curvature large enough not to crash into forming one or more tight folds.

If the ring is preformed, that is to say that the clamping pockets 10, 11 are arranged to maintain themselves substantially in the deployed position when they are at rest, and that the ring is under -gonflated, that is to say that said pockets contain an amount of filling fluid less than their nominal capacity, the radial expansion of the stomach 3 has the effect of pushing the crest portions 12, 13 to the periphery of the ring, and thus tends to crush each clamping pocket on itself, in a substantially radial centripetal movement.

Advantageously, this settlement is distributed upstream of the retaining means 20, that is to say above the apron 23 of the bridge, when the domes constituting the projecting parts of the clamping pockets are deformed elastically, and downstream of the means retaining, that is to say between the apron 23 and the back belt 21, when the pillars 24 flex by crushing the compressible cavity 22.

In other words, the clamping pockets 10, 11 and the retaining means 20 collapse together, so that even if the radial distance between the ridge line and the retaining means 20 is likely to decrease, The latter remains, however, substantially set back from the crest portions 12, 13, that is to say that the profile of the separation zone advantageously retains a certain functional concavity during the collapse.

In addition, this controlled differential deformation provides the ring with a large capacity for adapting and damping variations in the diameter of S'Organ 3 related to the operation of the latter. Advantageously, when the stomach then operates a return to the retracted position, its wall is freely recalled in a centripetal movement towards the axis (X-X ') and does not remain stuck between the clamping pockets 10, 11.

More particularly, the intermediate portion of the stomach wall may detach from the retaining means and move away from it to return to its floating position, without the risk of pinching or settling.

Advantageously, the peak portions 12, 13 and the retaining means 20 effect an elastic return concomitant with the contraction of the stomach, while maintaining both the double independent anchoring and the definition of a penetration depth limit P.

The behavior of the ring is thus particularly flexible, predictable and reproductible, which gives it a great versatility and excellent reliability.

BEST MODE OF REALIZING THE INVENTION

The invention finds its industrial application in the design and manufacture of surgical rings, and in particular gastric rings.

Claims

Implantable surgical ring (1) intended to be closed on itself to form a ciose loop (2) around an average axis of extension (X-X ') so as to be able to grip a biological organ (3) constituting a pocket or conduit for modifying the passage section of said biological organ, said ring being characterized in that it comprises at least a first clamping pocket (10) and a second clamping pocket (11) which are staggered one relative to the other along the mean extension axis (X-X ') and adapted to be filled by a filling fluid so as to be able to clamp the biological organ (3), said first and second clamping pockets (10,11) respectively having a first crest portion (12) and a second crest portion (13) which protrude inwardly of the buckle (2) to abut against said organ (3), and in that said first and second crest portions (12, 13) are separated from each other by a separation zone (14) which defines an empty clearance zone of sufficiently marked material to ensure a discontinuity of contact between the biological organ (3) and the surgical ring (1), between the crest portions (12, 13), and which comprises a retaining means (20) set back from said first and second crest portions (12, 13) and adapted to limit the depth (P) at which the organ biological constraint (3) is capable of penetrating between said first and second crest portions (12, 13), so as to avoid the alteration of the wall of the biological organ in the separation zone (14).

Surgical ring according to claim 1 characterized in that the retaining means (20), the first clamping pocket (10), and the second clamping pocket (11) delimits, between the first and second crest portions (12, 13), a depression (18) whose ratio (R1) of the width at mid-depth (D 1) by the depth (P) is greater than or equal to 0.5, and preferably substantially between 0.5 and 1.

3 - Surgical ring according to one of claims 1 or 2 characterized in that it comprises a back belt (21) supporting the first and second clamping pockets (10, 11).

4 - surgical ring according to claim 3 characterized in that the retaining means (20) comprises a bridge provided with an apron (23) for forming abutment against the biological organ 3, said apron (23) being supported by one or more flexible pillars (24) which rest on the back belt (21) and which are designed to allow the collapse of the apron (23) towards the outside of the buckle (2).

5 - Surgical ring according to claim 4 characterized in that the pillars (24) are merged with the side portions of the walls which define the first and second clamping pockets (10, 11) and which are opposite the one of the other, on both sides of the retaining means (20).

6 - Surgical ring according to one of the preceding claims characterized in that the retaining means (20) connects the first clamping bag (10) to the second clamping bag (11),

7 - surgical ring according to one of the preceding claims characterized in that the first and / or the second clamping pocket (10, 11) have a deformable structure capable of authorizing the slump of the first and / or second portion of crest (12; 13) towards the outside of the loop (2) under the expansion constraint of the biological organ (3), and in that the retaining means (20) also has a sufficiently deformable structure to substantially accompany said collapse.

- Surgical ring according to claim 7 characterized in that it has a recess (22) formed on the outer side of the loop (2) relative to the retaining means (20), between the first and the second clamping pocket (10). 11) and above said holding means (20) so as to facilitate the collapse of the latter. - Surgical ring according to one of the preceding claims characterized in that the retaining means (20) is arranged such that, when the first clamping bag (10) is filled with filling fluid, the volume occupied by said fluid filling within the latter extends on either side of the retaining means (20).

Surgical ring according to claim 9 characterized in that the first clamping pocket (10) comprises a first cavity (30) intended to contain the filling fluid, said first cavity (30) extending between a bottom wall (30F ) facing outwardly of the loop (2) and a crest wall (30C) facing inwardly of said slug (2), and in that the retaining means is located at a level of between 40% and 60% of the height utiie (hi) of said first cavity (30) measured between the bottom wall (30F) and the crest wall (30C).

Surgical ring according to one of the preceding claims, characterized in that the retaining means (20), the first clamping pocket (10) and the second clamping pocket (11) delimit between the first and second crest portions. (12, 13) a depression (18) whose ratio (R2) of the width (D2) at maximum depth of penetration by said maximum depth of penetration (P) is greater than or equal to 0.35 and preferably substantially between 0.35 and 1.

Surgical ring according to one of the preceding claims characterized in that the retaining element (20) is made of a biocompatible elastomeric material, such as silicone.

Surgical ring according to one of the preceding claims, characterized in that the retaining element (20) is integral with the first clamping pocket (10) and / or with the second clamping pocket (11).

Surgical ring according to one of the preceding claims characterized in that it has substantially a geometry of axis revolution (X-X ').