FR2929840A1 - UNDERGROUND LOCK RING - Google Patents

Abstract

The invention relates to 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 ring comprising: a flexible band provided with means junction means (3, 4) adapted to close said flexible band on itself, - at least a first support member (10) and a second support member (11) which protrude towards the biological organ, said ring being characterized in that said first and second support members (10, 11) are separated from one another and delimit between them a clearance zone (20) in which are housed at least part of the means junction (3, 4). Gastroplasty rings.

Description

UNDERGROUND LOCK RING

The present invention relates to the general technical field of surgical implants intended to be arranged in the body of a patient around a biological organ constituting a pocket or a duct, and in particular to the gastric rings to achieve a constriction of the stomach as part 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 provided with connecting means designed for closing said strip on itself so that it forms a closed loop around the biological organ, as well as at least a first support member and a second support member projecting towards the inside the loop to come to bear against the biological organ.

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, as well as related diseases, such as diabetes, cardiovascular diseases, or severe arthritis.

In particular, a known technique is to achieve a gastric constriction to reduce the size of the stomach and therefore the intake of food. B80473 / FR For this purpose, the use of gastroplasty rings implanted around the patient's stomach is frequently used to reduce the volume as well as the stoma diameter of the patient.

Generally, such gastroplasty rings comprise a flexible band made of elastomeric material and intended to be closed at both ends by appropriate closing means to enclose the stomach.

In addition, the known rings usually comprise an annular compression chamber located on the internal face of the flexible band and the volume of which is adjustable by adding or removing a filling fluid.

In general, the known implantable rings are satisfactory, but suffer from certain disadvantages.

In particular, because of their structural and functional complexity, the means for closing the ring and / or the filling means of the compression chamber frequently occupy a relatively large space, and must be arranged outside the chamber. ring, protruding from its periphery.

Of course, such projecting portions may be relatively bulky, and sometimes aggressive to the tissues of the biological organ itself but also tissues that surround it. This may result in some discomfort or risk for the patient.

In addition, the overall size of the rings of the prior art can complicate their introduction into the body of the patient and their handling during implantation. B80473 / FR The objects assigned to the present invention therefore aim to remedy the aforementioned drawbacks and to propose a new implantable surgical ring, particularly gastric, which, while having a good therapeutic efficacy, has a particularly small footprint and atraumatic character. .

Another object assigned to the invention is to propose a new implantable ring that is easily adjustable depending on the anatomy of the patient and the desired therapeutic effect.

Another object assigned to the invention is to propose a new implantable ring 10 which has a particularly simple and compact structure.

Finally, another object assigned to the invention is to provide a new implantable ring which has good stability and whose implementation is both safe and comfortable for the patient.

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 provided with joining means adapted to close said strip on itself so that it forms a closed loop around the biological organ, at least a first support member and a second bearing member which protrude inwardly of the buckle to bear against the biological organ, said ring being characterized in that said first and second bearing members are separated from each other and delimit between them a clearance zone in which are housed at least a portion of the connecting means, so as to reduce the overall size of the ring.

Other objects, features and advantages of the 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:

- Figure 1 illustrates, in a perspective view, a variant of surgical ring according to the invention in closed configuration.

- Figure 2 illustrates, in a perspective view, the ring shown in Figure 1 when in open configuration. - Figure 3 illustrates, in a partial perspective view, the female portion of the junction means implemented in the embodiment of the ring shown in Figures 1 and 2.

FIG. 4 is a sagittal sectional view of the ring shown in FIG. 1. FIG. 5 is a sagittal sectional view of the ring shown in FIG.

- Figure 6 illustrates, in a perspective view, another alternative embodiment of the ring according to the invention.

FIG. 7 illustrates, in a partial perspective view, with tearing of material according to a transverse sectional plane, the female part of the joining means implemented within the ring variant shown in FIG. 6. B80473 The present invention relates to an implantable surgical ring 1 which is 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.

For this purpose, the ring 1 comprises a flexible band 2 provided with joining means 3, 4 which are designed to close said flexible band 2 on itself so that it forms a closed loop around the biological organ.

More particularly, the flexible strip 2 is designed to wind geometrically around an average axis of extension (XX '), as shown in FIGS. 1 and 4, said extension axis () X') advantageously coinciding, after implantation, with the main direction of extension of the conduit or the pocket formed by the biological organ.

Preferably, the ring according to the invention constitutes a gastroplasty ring for the treatment of obesity and designed to be implanted around the stomach in order to reduce the diameter of the opening of the stoma, or to be implanted around the esophagus. Of course, the invention is not limited to this application and also relates to surgical rings forrnant artificial sphincters adapted for the treatment of urinary or faecal incontinence, or rings used for the regulation of blood flow.

Depending on its purpose, the surgical ring 1 will of course be adapted to the size, the environment and the sensitivity of the biological organ concerned by the constriction, such as bladder, urethra, intestine, artery, vein, etc. B80473 / FR Particularly preferably, the flexible strip 2, and more generally the ring 1, is able to pass from an open configuration corresponding to FIGS. 2, 5 and 6, to a closed configuration illustrated in FIGS. 1 and 4. .

Preferably, the connecting means 3, 4 are arranged substantially at the ends 5, 6 of the flexible band 2, so that the latter can be closed substantially towards its two ends 5, 6 to form a closed loop around the mean axis of extension (XX ').

In addition, said ends 5, 6 preferably come into contact with each other when the ring 1 is in a closed configuration, joining at a contact interface 30, so that the closed loop may have a substantially continuous inner contour, as shown in Figures 1 and 4.

Thus, by trapping the biological organ within said loop, it is possible to narrow the diameter of its passage section by throttling.

As illustrated by the two embodiments shown in FIGS. 1 and 6, the contact interface 30 may be indifferently straight or curved, radial or oblique with respect to the axis (XX ').

Of course, the geometry adopted by the closed loop thus formed by the flexible strip 2, in particular after implantation, is in no way limited.

However, the latter will preferably have a substantially rounded contour, and particularly preferably substantially circular and axis () O '). B804f 73 / FR More generally, the surgical ring 1 according to the invention will preferably have, when in the closed configuration, substantially a geometry of revolution axis (XX ').

Within the meaning of the invention, the joining means 3, 4 are designed to create a mechanical connection between two distinct portions of the flexible strip 2, and more particularly to cooperate with each other so as to join the two ends 5, 6 of said band 2, so that it delimits a closed contour in which the biological organ is contained.

In this respect, it is remarkable that the joining means 3, 4 according to the invention can be arranged in such a way that, when they cooperate, the flexible band 2 forms a loop that is certainly closed and sweat itself. that is to say delimiting a contour covering the entire perimeter of the biological organ without presenting an opening, but a loose loop, that is to say likely to undergo variations in its perimeter, in a manner substantially similar to a noose.

Moreover, the ring 1, and more particularly the joining means 3, 4, preferably comprise locking members 7, 8 able to hold the flexible band 2 in a closed configuration of substantially invariant perimeter, that is to say to say to achieve a firm closure of said flexible band 2 on itself. As such, it is remarkable that the flexible strip 2 preferably has a certain tensile strength, in order to limit the extension of the perimeter of the closed loop when it is subjected to radial expansion constraints exerted by the biological organ. B80.473 / FR Moreover, the ring 1 according to the invention comprises at least a first support member 10 and a second support member 11 which protrude inwardly of the loop so as to bear against the biological organ.

According to an alternative embodiment not shown, the first support member 10 and / or the second support member 11 may be formed by solid material beads, or by sealed bags containing a fixed and invariable amount of a filling fluid, such as air or physiological saline. However, particularly preferably, the first support member 10 and / or the second support member 11 are formed respectively pair a first inflatable pocket and a second inflatable pocket, and will both be assimilated in the following, for convenience description, to inflatable pockets. Inflatable bag means a bag intended to be filled by means of a filling fluid and comprising supply means for injecting or puncturing filling fluid into said bag, in particular from a device remote from said bag pocket, such as a syringe or implanted reservoir. Thus, one can advantageously obtain a flexible constriction of the pneumatic or hydraulic type of the biological organ when said inflatable pockets 10, 11 come into contact with the wall of this clernier.

Preferably, the inflatable bags 10, 11 are made of a biocompatible elastomeric material, of the silicone type.

Of course, the number, shape and dimensions of the inflatable bags 25 fitted to the ring are not limited. B8047.3 / FR In particular, according to an alternative embodiment not shown, the first and second inflatable pockets 10, 11 may be located substantially at the same abscissa along the axis (XX ') and form angular subdivisions of the flexible band 2, in the manner of a crenellated crown, about said extension axis (XX ').

However, particularly preferably, as illustrated in the figures, the closed loop wrapping around the mean axis of extension (XX '), the first support means 10 e1: the second means of support 11 are staggered relative to each other along said axis (XX ').

In other words, the inflatable bags 10, 11 are advantageously longitudinally offset, so that they come into contact with the biological organ each in a separate contact zone.

Advantageously, such an arrangement confers on the ring a particularly stable double anchorage, because it is not very sensitive to local losses of contact between one of the inflatable pockets and the biological organ, and moreover atraumatic insofar as, for a range of given support, it limits the total area of the contact areas between the inflatable pockets 10, 11 and said biological organ.

Preferably, said inflatable pockets, and more particularly their respective ridge portions projecting inwardly from the ring 1, are physically separated by a depression 12 which opens towards the inside of the ring 1. Particularly preferably, the inflatable pockets 10, 11, and more particularly their respective peak portions, are totally disjoint, the depression 12 forming a separation gap which extends sweat all the common extension length of said pockets. B80473 / FR Preferably, as shown in the figures, the first and the second support members 10, 11 are formed by annular structures which extend substantially parallel to each other.

More particularly, the inflatable pockets may advantageously extend substantially the entire length of the flexible band 2.

Advantageously, the inflatable bags 10, 11 are thus able to exert a radial centripetal clamping force against the biological organ, and thus to achieve each a constriction of the latter.

In addition, the first and second inflatable pouches are preferably 10 images of one another with respect to a sagittal plane of symmetry normal to the axis (XX ') and intersecting the ring 1, and more particularly the flexible band 2, in the middle.

Furthermore, according to an alternative embodiment, the first inflatable pocket 10 and the second inflatable pocket 11 can communicate with one another, and in particular form the two protruding projections of a same chamber.

According to an important characteristic of the invention, the first support member 10 and the second support member 11 are separated from one another and delimit between them a clearance zone 20 in which at least 20 a part of the connecting means 3, 4, so as to reduce the overall size of the ring 1.

In other words, the first and the second support members are at least partially disjoint and distant from one another, so as to provide a vacant space between them which is usefully exploited to house all or part of junction means 3, 4 and / or locking members 7, 8. B80473 / FR Thus, the junction means 3, 4 are advantageously nested in the internal structure of the ring, in an underground housing, and do not, or little, protrude at the periphery of the ring towards the outside thereof.

As such, it is remarkable that any residual overflow of said connecting means 3, 4 beyond the dorsal portion of the flexible strip 2 is advantageously limited, which greatly simplifies the introduction and implementation of the ring 1, while reducing the discomfort caused by it after implantation.

Preferably, the first and / or second inflatable bag 10, 11 are connected to a supply duct 22 which allows the transfer of filling fluid to or from said first and second inflatable bags 10, 11, the clearance 20 then being able to accommodate said supply conduit 22. In other words, according to a feature which can constitute an entire invention, regardless of the arrangement of the joining means 3, 4, the surgical ring 1 has a clearance zone 20 dug in the flexible strip 2, and more particularly between the first and the second inflatable bag 10, 11, in which can be at least partly inserted, and particularly preferably completely buried, a section of the duct supply 22 which connects the first and / or second inflatable bag 10, 11 to a remote inflation device.

Thus, the supply duct 22 preferably runs along said inflatable pockets over at least a certain angular portion of the ring.

Of course, said supply duct 22 may comprise one or more channels, and for example to separate the power supplies of each of the different inflatable pockets. B80473 / FR However, preferably, the first and the second inflatable bag 10, 11 are fed by a common and single supply conduit 22 which distributes the fluid in said pockets 10, 11 via a manifold 23 which communicates with said pockets at the level of gills 24 provided for this purpose.

Thus, the clearance zone 20 is preferably large enough to accommodate at least a portion of the supply duct 22, and thus mask part of the latter within the structure of the ring 1.

More particularly, the clearance zone 20 advantageously makes it possible to eliminate between the inflatable pockets 10, 11 a portion of the duct 22 over part or all of its height measured in a direction transverse to the axis (XX ').

Preferably, as illustrated in FIGS. 1, 2, 4, 5 and 6, the supply duct 22 is integrated with the joining means 3, 4 and forms a male member 3 of the latter.

In addition, the clearance zone 20 preferably forms a trench which is open towards the outside of the loop and which is at least partly covered by a cover plate 25 so as to form a sleeve 26 which constitutes a female body 4 junction means 3, 4.

The clearance zone 20 may therefore advantageously be in the form of a tunnel opening which is adjacent to the inflatable pockets 10, 11, and more precisely pierced between them and parallel thereto.

Advantageously, the cover plate may be curved and form a hemicylindrical cap overhanging the clearance zone 20. Preferably, as shown in FIGS. 1 and 4, the supply duct 22 is arranged to be able to to be threaded into the sleeve 26 in order to operate the junction of the flexible band on itself, that is to say that the male junction member 3 can be passed through the tunnel island so as to form the closed loop by a cord / buttonhole connection.

Advantageously, as illustrated in particular in Figures 3 and 7, it is the walls of the inflatable pockets 10, 11 which form at least in part the lateral limits of said tunnel.

Furthermore, it is remarkable that the outlet orifice 27 of the sleeve 26, which opens outwardly from the ring, is preferably at least partly, and preferably mostly, flush with the surface of the flexible strip 2 , that is to say, advantageously has no or little elements protruding from the outer contour of the closed loop.

More particularly, when the flexible band 2 is closed on itself and the closed loop has externally, in projection in a plane normal to the axis of extension (XX '), a first substantially circular periphery contour C1 of axis (XX ') and of nominal radius RI, the connecting means 3, 4, considered at the junction of the flexible strip 2 on itself are advantageously contained in a fictional circle C2 of axis () X') of which the radius R2 is substantially between 0.9 times and 1.1 times the nominal radius RI of the first contour C1, as illustrated in FIG.

In other words, when the ring 1 is in ferrne configuration, the junction means 3, 4, and in particular the supply duct 22, located vertically above the contact interface 30 are advantageously mounted re-entrant, flush, or at the very most slightly salient with respect to the regular nominal contour Cl of the dorsal portion of the ring 1, i.e.

B80473 / FR advantageously fit into the minimum intrinsic bulk of the flexible band 2 and the inflatable pockets 10, 11.

Thus, the ring 1 has at most a very small radial overhang at the level where the joining means 3, 4 operate the junction of the flexible strip 2 on itself, which advantageously limits the bulk of the ring in its implantation area and allows it to confer a substantially rounded and atraumatic contour.

By the expression located vertically above the contact interface 30, the elements located in the extension of the angular sector coming from the extension axis (XX ') and covering the interface 30 at which the ends 5, 6 of the flexible band 2 meet.

In a particularly preferred manner, as illustrated in particular in FIGS. 1 and 4, the sleeve 26 is disposed in an overlapping manner between the annular structures formed by the first and second bearing members 10, 11 and follows a generator axis ( YY ') substantially tangent to the latter. In other words, the female joining means 4 advantageously corresponds to a cylindrical gallery, preferably of circular section, which is hollowed out in the thickness of the ring 1 at least partially between the first and the second inflatable bag 10, 11 and in a direction substantially tangent to the contour of the closed loop at the contact interface 30.

Furthermore, the feed duct 22 preferably comprises at least one lug 7 arranged to cooperate by snapping with: the sleeve 26, and 25 more particularly with a bearing flange 8 of said sleeve 26. 880473 / FR Thus, the lug 7 and the support flange 8 may advantageously form the locking members adapted to maintain the ring in its closed configuration.

Preferably, the lug 7 is integral with the supply duct 2: 2 and protrudes in a radial direction centrifugal relative to the axis (XX ').

Advantageously, the locking of the ring, and more particularly the mechanical snapping of the lug 7 against the flange 8, is reversible, so that the surgeon can, after implantation, be temporarily loosen the loop without completely undoing this one. ci to operate a repositioning of the ring, or completely open said loop so as to extract the ring.

Of course, the support flange 8 may be formed by a housing disposed inside the sleeve 26, or, particularly simply, be formed by the dorsal portion of the ring, around the periphery of the orifice 27 of the sleeve 26, and more particularly by a edge of the cover plate 25. Finally, the ring 1 may advantageously be provided with tongues 31, 32, 33,. 34 designed to allow the gripping and manipulation of said ring, and more particularly to allow the surgeon to proceed to the opening of the flexible band 2, by maneuvering the locking members 7, 8 reversible.

Advantageously, the ring 1 according to the invention has a particularly compact structure, insofar as it optimizes the spatial distribution of its various functional structures, and in particular its connection means with respect to its support members, such that B80473 / FR concentrates in a minimum of space all of said functional structures while retaining the intrinsic functions and advantages of said structures.

Thus, the ring 1 according to the invention has an optimized size, and, in particular, considerably reduces the amount of elements protruding outwardly of the ring relative to the rounded ridge thereof, this which contributes to simplify the establishment of said ring and to limit the discomfort that it is likely to cause the neighboring tissues of the biological organ treated.

This results in both a better tolerance of the ring by the patient and better ergonomics of the same ring vis-à-vis the surgeon.

In addition, the arrangement of the ring 1 according to the invention advantageously makes it possible to manufacture said ring in a particularly simple manner, by fastening to one another two monobloc subassemblies, which can for example be obtained by injection plastic, namely a first subassembly comprising the inflatable pockets 10, 11 and a second subassembly comprising the dorsal portion of the flexible band 2 integrally formed with the cover plate 25 and the tongues 31, 32, 33, 34.

Therefore, the compact and multi-functional structure of the ring also has the effect of reducing the manufacturing cost thereof. B80473 / EN

Claims (4)

CLAIMS1 - 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) provided with means joining means (3, 4) adapted to close said flexible band (2) on itself so that it forms a closed loop around the biological organ, at least a first support member (10) and a second support member (11) projecting inwardly of the loop to abut against the biological organ, said ring being characterized in that said first and second support members (10, 11 ) are separated from one another and delimit between them a clearance zone (20) in which are housed at least a portion of the connecting means (3, 4), so as to reduce the overall size of the ring. 2 - Ring according to claim 1 characterized in that the first and / or the second support member (10, 11) are formed respectively by a first and a second inflatable bag. 3 - ring according to claim 2 characterized in that the first and / or second inflatable bag (10, 11) are connected to a supply duct (22) for the transfer of filling fluid to or from said first and second inflatable pockets, and in that the clearance zone (20) is adapted to accommodate said supply duct (22). B80473 / EN 4 - ring according to claim 3 characterized in that the supply duct (22) is integrated with the connecting means (3, 4) and forms a male member (3) thereof. Ring according to one of the preceding claims, characterized in that the clearance zone (20) forms a trench which is open towards the outside of the loop and which is covered at least in part by a cover plate (25). so as to form a sleeve (26) constituting a female member (4) connecting means (3, 4). 6 - ring according to claims 4 and 5 characterized in that the supply duct (22) is arranged to be threaded into the sleeve (26) to effect the junction of the flexible band (2) on itself. 7 - Ring according to claim 6 characterized in that the supply duct (22) comprises at least one lug (7) arranged to cooperate by snapping with the sleeve (26). 8 - Ring according to one of the preceding claims characterized in that, when the flexible strip (2) is closed on itself, the closed loop has externally a first contour (Cl) substantially circular axis (XX ') and in that, at the junction of the flexible band (2) on itself, the connecting means (3, 4) are contained in a fictitious circle (C2) of axis (XX ') whose radius ( R2) is substantially between 0.9 times and 1.1 times the nominal radius (RI) of the first contour (Cl). 9 - Ring according to one of the preceding claims characterized in that the closed loop wraps around a mean axis of extension (XX ') and in that the first support means (10) and the second means of support (11) are staggered with respect to each other along said axis (XX '). A ring according to claims 5 and 9 characterized in that the first and second bearing members (10, 11) are formed by annular structures which extend substantially parallel to each other and the sleeve (26) is disposed in an overlapping manner between said annular structures and follows a generator axis (YY ') substantially tangential thereto. 11 - Ring according to one of the preceding claims characterized in that it constitutes a gastroplasty ring for the treatment of obesity. B80473 / EN