WO2009136123A2

WO2009136123A2 - Ring having subsurface bolt

Info

Publication number: WO2009136123A2
Application number: PCT/FR2009/050673
Authority: WO
Inventors: Pascal Paganon
Original assignee: Compagnie Europeenne D'etude Et De Recherche De Dispositifs Pour L'implantation Par Laparoscopie
Priority date: 2008-04-14
Filing date: 2009-04-10
Publication date: 2009-11-12
Also published as: FR2929840A1; FR2929840B1; WO2009136123A3

Abstract

The invention relates to an implantable surgical ring (1) to be placed around a biological organ and constituting a pocket or duct designed for adjustment of the section through which said biological organ passes, said ring comprising: -a flexible band provided with a linking means (3, 4) designed to close said flexible band on itself, -at least one first bearing part (10) and a second bearing part (11) projecting towards the biological organ, said ring being characterized in that said first and second bearing parts (10, 11) are separated from each other and define therebetween a releasing area (20) wherein at least part of the linking means (3, 4) fits. The invention can be used in gastroplastic rings.

Description

UNDERGROUND LOCK RING

TECHNICAL AREA

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.

PRIOR ART

It is known to perform surgical procedures 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.

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 inner face of the flexible band and whose volume 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 closure means of 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 protruding parts can be relatively bulky, and sometimes aggressive vis-à-vis the tissues of the biological organ itself but also tissues that surround it. This can result in some discomfort, even 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.

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, 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 which has a particularly simple and compact structure.

Finally, another object assigned to the invention aims 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 designed to close said strip on itself so that it forms a closed loop around the biological organ, at least one first support member and a second support member which project towards the inside of the loop so as to bear against the biological organ, said ring being characterized in that said first and second members the support 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.

SUMMARY DESCRIPTION OF THE DRAWINGS

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 connecting means implemented within the ring embodiment shown in Figures 1 and 2.

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

- Figure 7 illustrates, in a partial perspective view, with tearing material in a transverse sectional plane, the female part of the connecting means implemented within the ring variant shown in Figure 6.

BEST MODE OF REALIZING THE INVENTION

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 a mean axis of extension (X-X '), as shown in FIGS. 1 and 4, said extension axis (X- 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 forming 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.

In a particularly preferred manner, the flexible band 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 (X-X ').

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 (X-X ').

Of course, the geometry adopted by the closed loop thus formed by the flexible band 2, especially after implantation, is not limited.

However, the latter will preferably have a substantially rounded contour, and particularly preferably substantially circular and axis (X-X ').

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 ').

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.

As such, it is remarkable that the joining means 3, 4 according to the invention can be arranged such that, when they cooperate, the flexible band 2 forms a loop certainly "closed" on itself, c 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 say likely to undergo variations in its perimeter, 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.

Furthermore, the ring 1 according to the invention comprises at least a first support member 10 and a second support member 11 which project towards the inside 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 respectively formed by a first inflatable pocket and a second inflatable pocket, and will both be assimilated in the following, for convenience description, to inflatable pockets. By "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 remote device of said pocket, such as a syringe or an 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 the latter.

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 equipping the ring are not limited.

In particular, according to an alternative embodiment not shown, the first and second inflatable pockets 10, 11 can be located substantially at the same abscissa along the axis (X-X ') and form angular subdivisions of the flexible strip 2, to the manner of a crenellated crown, about said axis of extension (X-X ').

However, particularly preferably, as is illustrated in the figures, the closed loop wrapping around the mean axis of extension (X-X '), the first support means 10 and the second means of support 11 are stages relative to each other along said axis (X-X ').

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 that extends over the entire common extension length of said pockets.

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 over 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 each to produce a constriction of the latter.

In addition, the first and second inflatable pouches are preferably images of each other with respect to a sagittal plane of symmetry normal to the axis (X-X ') and cutting the ring 1, and more particularly the flexible strip 2, in the middle.

Moreover, according to an alternative embodiment, the first inflatable pocket 10 and the second inflatable pocket 11 can communicate with each other, 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 are housed at least one part of the joining 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.

Thus, the junction means 3, 4 are advantageously imbricated in the internal structure of the ring, in an "underground" housing, and do not make, or little, protrusion at the periphery of the ring towards the outside of that -this.

The clearance zone 20 is therefore advantageously dug between the support members 10, 11, at least partly under the dorsal portion of the flexible band, and more particularly under the dorsal wall which delimits said support members 10, 11 by relative to the outside of the ring 1, in order to accommodate at least part or even a majority or all of the joining means 3, 4 in a "landfill" zone between the face internal of the ring, that is to say the face that comes into contact with the biological organ, and said back wall of the support members.

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 band 2, and more particularly between the first and the second inflatable bag 10, 11, in which can be at least partially inserted, and particularly preferably completely buried, a portion of the supply duct 22 which connects the first and / or second pocket inflatable 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 conduit 22 may comprise one or more channels, and for example to separate the power supplies of each of the different inflatable bags. 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 "hide" part of the latter within the structure of the ring 1.

More particularly, the clearance zone 20 advantageously makes it possible to "disappear" 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 (X- X ').

Preferably, as shown in Figures 1, 2, 4, 5 and 6, the supply conduit 22 is integrated with the connecting means 3, 4 and forms a male member 3 thereof.

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 an opening tunnel which is adjacent to the inflatable pockets 10, 11, and more precisely "pierced" between them and parallel thereto. Advantageously, the cover plate can 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 be threaded into the sleeve 26 in order to effect the joining of the flexible band to itself, that is, that is, the male junction member 3 can be passed through the tunnel so as to form the closed loop by a cord / buttonhole type 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 (X-X '), a first substantially circular peripheral contour C1 d Axis (X-X ') and nominal radius R1, the junction means 3, 4, considered at the junction of the flexible band 2 on itself are advantageously contained in a fictional circle C2 axis (X -X ') whose radius R2 is substantially between 0.9 times and 1, 1 times the nominal radius R1 of the first contour C1, as shown in Figure 4. In other words, when the ring 1 is in closed configuration, the junction means 3, 4, and in particular the supply duct 22, located vertically above the contact interface 30 are advantageously mounted reentrant, flush, or at most slightly slightly protruding from the regular nominal contour C1 of the dorsal portion of the ring 1, that is to say, advantageously fit into the minimum intrinsic bulk of the flexible strip 2 and inflatable pockets 10, 11, substantially within the perimeter defined by the back wall of said pockets.

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" is meant the elements situated in the extension of the angular sector coming from the extension axis (X-X ') and covering the interface 30. at which the ends 5, 6 of the flexible strip 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 supply duct 22 preferably comprises at least one lug 7 arranged to cooperate by snapping with the sleeve 26, and more particularly with a bearing flange 8 of said sleeve 26.

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 22 and protrudes in a radial direction centrifugal relative to the axis (X-X ').

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 can advantageously be provided with tongues 31, 32, 33, 34 designed to allow 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 it 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 strip 2 integral 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 cost of manufacturing thereof.

POSSIBILITY OF INDUSTRIAL APPLICATION

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 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 connecting means (3, 4) designed 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) which project inwardly of the loop in order to bear 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 at least part 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). 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.

5 - 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 (C1) substantially circular axis (X-X ' ) and in that, at the junction of the flexible band (2) on itself, the junction means (3, 4) are contained in a fictitious circle (C2) of axis (X-X ') whose radius (R2) is substantially between 0.9 times and 1, 1 times the nominal radius (R1) of the first contour (C1).

9 - Ring according to one of the preceding claims characterized in that the closed loop wraps around a mean axis of extension (X-X ') and in that the first support means (10) and the second way of support (11) are stacked with respect to each other along said axis (X-X ').

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 one another and in that the sleeve (26) is disposed in an overlapping manner between said annular structures and follows a generator axis (YY ') substantially tangential thereto.

-Annle according to one of the preceding claims characterized in that it constitutes a gastroplasty ring for the treatment of obesity.