FR2922435A1 - Surgical ring e.g. beveled gastric ring, for use around e.g. stomach to treat fecal incontinence, has end portions inclined with respect to surface of band so as to overlap portions on contour portion that defines band around organ - Google Patents

Abstract

The ring (1) has a flexible band (2) including an annular locking chamber(10) that contains filling fluid and is provided with partially bent end portions (10A, 10B) at its ends. The end portions are arranged for being in contact with one another when the flexible band is closed on itself to form a circular close loop. The end portions are inclined with respect to a longitudinal mean extending surface (SIGMA) of the band so as to overlap the end portions on a contour portion (C) that defines the flexible band around a biological organ e.g. stomach or oesophagus, of a patient.

Description

GASTRIC RING BISAUTE

The present invention relates to the general technical field of surgical implants intended to be implanted in the body of a patient around biological organ (s) constituting a pocket or a duct, 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 relates more particularly to a surgical ring intended to be implanted in the body of a patient around a biological organ constituting a pocket or a duct for modifying the passage section of said organ when it is enclosed by the ring, said ring being formed by a flexible band intended to be closed on itself to form a closed loop, said flexible band comprising at least one annular clamping chamber adapted to contain a filling fluid and provided at its ends with a first portion extremal and a second extremal portion which are arranged to come into contact with each other when the flexible band is closed on itself.

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 the diabetes, cardiovascular diseases, or severe arthritis.

In particular, a known technique is to achieve a gastric constriction reducing the size of the stomach and therefore the intake of food. B70450 / EN 2 For this purpose, the use of gastroplasty rings implanted around the patient's stomach is frequently used to reduce its volume as well as the diameter of its passage (stoma). In a well known manner, such gastroplasty rings comprise a flexible band, made of elastomeric material, which is 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 clamping chamber located on the inner face of the flexible band 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 internal diameter of the ring by a radial expansion or retraction of the chamber, as well as the degree of compression exerted by said chamber. , depending on the amount of fluid injected.

Such implantable rings are generally satisfactory but suffer, however, from a certain number of disadvantages, in particular due to a certain functional sensitivity with respect to the level of inflation of the compression chamber. Indeed, the annular compression chamber is generally arranged so that its ends abut against each other when the ring is closed around the stomach, so that the constriction is normally performed on all around it.

However, in case of insufficient inflation of said pocket, the wall that defines the latter may have excessive flexibility, so that when the stomach exerts a centrifugal pressure against the ring, the wall B70450 / FR of said chamber tends to be driven, causing a spacing of its ends in a corner opening.

This generally results in the appearance of a crevice-like gap, the edges of which are formed by the ends of the chamber, which is sufficiently deep and extensive that the stomach wall tends to penetrate into it forcefully.

The stomach wall can thus be exposed to excessive local compression pinch type, causing pain for the patient, or tissue necrosis.

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 ensures atraumatic constriction of the organ irrespective of its level of filling.

Another object assigned to the invention is to propose a new surgical ring whose implementation is particularly simple and fast.

Another object assigned to the invention is to provide a new surgical ring which is particularly robust and durable.

Another object assigned to the present invention is to provide a new surgical ring which is particularly simple and inexpensive design.

Another object assigned to the present invention is to provide a new surgical ring which exhibits increased stability once implanted. B70450 / FR Finally, another object assigned to the invention is to propose a new surgical ring which has a long life and whose operation is particularly reliable.

The objects assigned to the invention are achieved by means of a surgical ring intended to be implanted in the body of a patient around a biological organ constituting a pocket or a duct for modifying the passage section of said organ when it is enclosed by the ring, said ring being formed by a flexible band intended to be closed on itself to form a closed loop, said flexible band comprising at least one annular clamping chamber designed to contain a filling fluid and provided at its ends with a first end portion and a second end portion which are arranged to come into contact with each other when the flexible band is closed on itself, said ring being characterized in that the first and second end portions are inclined relative to the average longitudinal extension surface of the flexible strip so as to overlap on at least a portion of the outline that delimits ite said flexible band around the organ.

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 shows, in a perspective view, an embodiment of surgical ring according to the invention in closed configuration.

FIG. 2 illustrates, in a view from above, the ring represented in FIG. 1. B70450 / FR - FIG. 3 illustrates, in a perspective view, the variant embodiment of the ring corresponding to FIGS. 2 but in open configuration.

FIG. 4 illustrates, in a view from above, the implantable ring illustrated in FIG. 3; FIGS. 5A and 5B illustrate, in partial diagrammatic views from above, the operation of certain implantable rings of the prior art. .

- Figures 6A, 6B and 6C illustrate, in partial schematic views from above, modes of operation of a ring variant according to the invention.

- Figure 7 illustrates, in a schematic longitudinal sectional view, the implantable ring corresponding to Figures 1 to 4 when it is implanted around the body to be clamped.

In the description which follows, reference will be made, by way of example only 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 of the 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 a biological organ constituting a pocket or a conduit in order to modify the passage section of said member when the latter is enclosed by the ring. B70450 / FR 6 Thus, the ring 1 according to the present invention can be adapted for the treatment of urinary or faecal incontinence, or for the regulation of blood flow.

Depending on the application, the surgical ring 1 will of course be adapted to the dimensions, the environment, and the sensitivity of the organ concerned by the constriction, such as bladder, urethra, intestine, artery, vein, etc.

The implantable surgical ring 1 according to the invention is formed by a flexible band 2, preferably made of a silicone-type elastomeric material, said flexible band being intended to be closed on itself to form a closed loop of axis. means of extension (XX ') in which is enclosed the biological organ 3 which seeks to change the passage section.

For convenience of description, it will be considered that when the surgical ring 1 is in the closed position, as is illustrated in FIGS. 1 and 2, the flexible band 2 forms a substantially circular closed loop, i.e. say that the contour C delimited by said flexible band 2 around the member 3 is preferably a circle. However, said contour C may also be a closed curved line of any shape.

The mean axis of extension (XX ') in the sense of the invention corresponds to the generating line of the cylindrical sleeve that forms the surgical ring 1 when it is in closed configuration. According to an alternative embodiment in which the surgical ring 1 substantially forms, in the closed position, a circular base cylinder, said mean extension axis (XX ') corresponds to the straight line forming the axis of revolution of said ring and passing by the center of the contour C. In normal operation on the stomach, the mean axis of extension (XX ') extends substantially vertically. B70450 / FR 7 To move from the open configuration illustrated in FIGS. 3 and 4 to the closed configuration illustrated in FIGS. 1 and 2, the loop is formed by bringing the ends 4, 5 of the strip closer to one another. flexible 2, then locking the ring 1 with the appropriate closure means 6, 7.

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

The closing means 6, 7 are designed to cooperate with one another so as to lock the ring 1 in its closed configuration. By way of example, it is possible to use for this purpose a sleeve 6 fixed on the first end 4 and intended to receive a tongue 7 associated with the second end 5, said tongue 7 preferably comprising one or more lugs 7A so as to allow a snap type assembly with the sleeve 6.

According to the invention, the flexible band 2 comprises at least one annular clamping chamber 10 which is designed to contain a filling fluid and which is provided at its ends with a first end portion 10A and a second end portion 10B which are arranged to come into contact with each other when the flexible band is closed on itself, as is illustrated in Figures 1 and 2.

Thus, the first end portion 10A substantially corresponds to the first end 4 of the flexible band 2, while the second end portion 10B substantially forms the second end 5 of said flexible band 2, so that said first and second end portions 10A 10B can be brought together in the closed configuration at a common contact interface 11. In addition, the clamping chamber 10 is delimited by at least one inner wall 15 which is intended to come into contact with the body 3 to be clamped.

In closed configuration, said inner wall delimits inside the ring a lumen through which the member 3 passes. In a plane P of projection normal to the mean axis of extension (XX '), the border of said light is drawn by the contour Ç.

The inner wall 15 is preferably formed by a sufficiently flexible membrane to deform elastically and absorb slight radial centrifugal expansion movements of the stomach.

Of course, the invention is not limited to a particular shape, size, arrangement or number of clamping chambers.

In particular, according to a preferred embodiment, the surgical ring 1 comprises at least two clamping chambers 10, 12 which are axially staggered, that is to say substantially superimposed and preferably spaced apart at a distance from one another. along the middle axis of extension (XX ').

In such an embodiment comprising a plurality of clamping chambers, the latter are preferably fed by a common common feed collector 17 (forming for example a Y-fork in the case of two chambers).

Preferably, the first end portion 10A of the first clamping chamber 10 has a substantially similar profile to that of the first end portion 12A of the second clamping chamber 12. B70450 / FR 9 Similarly, the second end portion 10B of the first clamping chamber 10 preferably has a profile substantially similar to that of the second end portion 12B of the second clamping chamber 12.

Thus, the first end portions 10A, 12A (respectively the second end portions 10B, 12B) of the clamping chambers 10, 12 preferably have substantially similar profiles, located substantially plumb with each other, so that to form a common contact interface 11, that is to say to present a single surface, optionally cut or perforated, opposite their counterparts of the opposite end of the flexible strip. Advantageously, this similarity in the arrangement, and more particularly in the cutting of the end portions of a clamping chamber to another simplifies the manufacture of the ring as the handling of said ring during its implementation.

According to an important characteristic of the invention, the first end portion 10A and the second end portion 10B are inclined relative to the average longitudinal extension surface E of the flexible band 2 so as to overlap on at least a portion of the outline C delimits said flexible band 2 around the member 3.

Within the meaning of the invention, the average longitudinal extension surface E corresponds to a dummy surface which has the same width (measured along the mean axis of extension (XX ')) as that of the flexible strip 2, c' that is to say which has substantially the overall thickness of the ring 1, which is substantially tangential to the inner wall 15 of the clamping chamber 10, which extends substantially parallel to the mean axis of extension (XX '), and whose length corresponds substantially to the perimeter of said contour C. B70450 / FR 10 More particularly, in the case where the ring forms a circular base loop, the average longitudinal extension surface corresponds to a kind of ribbon wound on itself to form a circular base cylinder, whose radius is equal to that of the light 16, and generatrix (XX ').

Within the meaning of the invention, the inclination of the first and second end portions 10A, 10B means that the surfaces of said end portions, considered in projection in a plane P normal to the mean axis of extension (XX '), are not do not extend parallel to the normal direction N to the inner wall 15 of the clamping chamber 10 considered at the internal junction point D1 where the first and second end portions and the stomach wall meet.

In other words, the director vector of the first extremal portion 10A and that of the second extremalel0B portion, considered in particular at the internal junction point D1, are not borne by a radius coming from the mean axis of extension (XX ') but are the resultant of both a normal component with an average longitudinal extension area 1 (thus radial) and a non-zero tangential component carried by the tangent direction T to the mean longitudinal extension area 1 at internal junction point D1.

Thus, as illustrated in FIG. 1, the first end portion 10A can advantageously cover, substantially in its entirety, the second end portion 10B, so as to be interposed between the latter and the wall of the body grip.

Said covering is advantageously substantially over the entire width of the flexible strip 2, and more particularly of the B70450 / FR 11 clamping chamber 1, that is to say substantially over the entire thickness of the ring 1 considered according to the average axis of extension () (X ').

In addition, the first end portion 10A and the second end portion 10B preferably have substantially conjugate shapes. Advantageously, the contact interface 11 will thus be of the surface type. It is remarkable that such a surface support, preferably continuous and extended over the entire surface of one or the other of the first and second end portions 10A, 10B, advantageously has the best possible distribution of the radial stresses and consequently gives ring 1 a behavior that is both more resistant and more homogeneous.

Furthermore, the shape matching between the first and second ends 4, 5 of the flexible band 2 facilitates the placement of the ring by providing easily identifiable and manipulable marker stops in vivo.

Of course, it is nevertheless conceivable without departing from the scope of the invention to make a discontinuous contact between the first end portion 10A and the second end portion 10B.

Particularly advantageously, the transverse superposition due to the inclination of the ends 4, 5 of the flexible strip, and more particularly of the end portions 10A, 10B of the clamping chamber 10 according to the invention, makes it possible to avoid The appearance of a crevice-type discontinuity at the inner wall 15 which comes into contact with the organ 3. This prevents pinching or localized frowning of the stomach tissues 25 which may lead to necrosis of the latter. Indeed, the inventors have found that on certain gastric rings of the prior art, the substantially radial arrangement of the contact interface 11 'between the ends of the chamber 4', 5 'could expose the ring, as shown in Figures 5A and 5B, the appearance of a kind of crack by separation and spacing of the end surfaces under the combined effect of centrifugal normal thrust FN and tangential tractions FT1, Opposite FT2 exerted by the stomach on the ring when the stomach wall seeks to expand, for example during ingestion of food.

This detachment of the extremal portions has the effect of creating a cavity in which the stomach wall tends to interfere, which can cause its damage.

On the contrary, on the ring 1 according to the invention, the expansion forces which result in a combination of FN centrifugal normal stresses and FT1 and FT2 antagonistic tensile stresses do not have the effect of separating the first and second extremal portions 10A, 10B away from one another by tearing or peeling, but rather to keep them pressed against each other.

This is advantageously obtained by the oblique disposition of the contact interface 11 between said first and second end portions.

Indeed, thanks to this arrangement, the centrifugal normal stress FN tends on the one hand to crush the tip of the first end portion 10A against the second end portion 10B, including in case of collapse of the inner wall 15 of the chamber when this is made flaccid due to a lack of inflation fluid, as shown in FIG. 6B, whereas, on the other hand, the inclined contact interface 11 can advantageously be used locally as a sliding surface. allowing B70450 / FR a certain extension of the perimeter of the contour C, in particular during the removal of the inner wall 15 by deflation, without causing a marked discontinuity between the first and second end portions, as shown in Figure 6C.

Thus, even if said contour C can then reveal a slight recess, the latter permanently has an opening sufficient to not imprison any portion of the stomach wall.

More particularly, the transition between the two ends 4, 5 of the flexible band 2 will be soft enough so that the stomach wall can at any time marry substantially without collapsing or penetrate into a narrow gap. Of course, the abovementioned slumping and sliding behaviors can be combined according to the circumstances of stressing of the ring 1, the filling level of the chamber 10, the flexibility and the initial disposition of the inner wall 15, etc.

According to a preferred embodiment, the inner wall 15 joins the first end portion 10A inside the loop at an edge 20 at a beak angle substantially between 5 ° and 85 °.

Beak angle is the angle formed by the intersecting mean planes which substantially extend the surface portions of the first end portion 10A and the inner wall 15 at their junction. More particularly, the beak angle is measured, as is particularly illustrated in FIG. 4, in a plane P normal to the extension axis (XX '), between the tangent T and the internal wall 15. and more particularly to the contour C, and B70450 / FR 14 the director vector of the separation line L which corresponds to the projection in the plane P of the outer surface of the first end portion 10A, said director vector being considered at the point internal junction QI.

Advantageously, the beak angle α is an acute angle, and particularly preferably, is substantially less than or equal to 45 °, so that the first end portion 10A forms a kind of beveled tip. Of course, the edge 20 is preferably blunt or rounded so as to maintain its atraumatic character, but it does not form any significant recess capable of locally breaking the continuity of the contour C and cause the pinch effect or frowning of the aforementioned stomach wall.

Preferably, the first and / or second end portions 10A, 10B are at least partly, and preferably all, curved.

For convenience of description, it is considered that the separation line L which substantially delimits the projected contour of the first and / or second end portion 10A, 10B, and which corresponds more particularly to the projection of the contact interface 11 in the plane P extends between an internal junction point QI located at the inner wall 15, and up to an external junction point 522 located at the periphery of the ring, substantially at its free backside. . Said separation line thus marks the physical cut that fixes the boundary between the first and the second end 4, 5 of the flexible strip 2. B70450 / FR 15 Thus, according to a preferred embodiment, said separation line L is thus curved , and more precisely tends to deviate from the normal N to the inner wall 15 considered at the internal junction point Q1.

Such an arrangement confers on the flexible band 2, especially when it is unwound and introduced into the body of the patient during implantation, a substantially atraumatic character.

Preferably, the first and / or the second end portion 10A, 10B have a generally concave shape with respect to the inside of the ring, ie vis-à-vis the interior of the loop formed by the flexible strip 2. In other words, the first and / or the second end portion 10A, 10B are curved toward the outside of the ring.

Such an arrangement advantageously confers an excellent seating of the first end 4 on the second end 5 when the ring is in closed configuration and allows the ring 1, and more particularly the clamping chamber 10 to absorb the movements of the expansion or at least the centrifugal radial compressive forces exerted by the stomach 3 without undergoing deformation or fatigue of its structure.

Although the profile of the first and second end portions 10A, 10B may be arbitrary, and have for example several consecutive curved segments of distinct curvatures or a continuously variable curvature between the internal junction point 01 and the external junction point 02, the radius the curvature of the first and / or second end portion 10A, 10B is preferably substantially constant. B70450 / FR 16 In other words, the profile of the line of separation between the ends 4, 5 of the flexible strip 2 is preferably an arc of a circle.

Advantageously, the contact interface 11 may thus be of the support-plane type if the separation line is rectilinear, or of the cradle type if said separation line is curved.

In either case, it is advantageous to obtain a substantially continuous surface contact sliding support type.

Moreover, although it is conceivable for the inclination of the first and second end portions 10A, 10B to be located substantially in the internal region of the ring, at the internal wall 15 of the clamping chamber 10 and in the immediate vicinity of the internal junction point f1, said inclination of the first and / or the second end portion 10A, 10B is preferably maintained right through the transverse section of said clamping chamber 10.

In other words, although it is conceivable for the dividing line L to have a first inclined inner portion followed by a second substantially radial and rectilinear section, the said dividing line is preferably inclined relative to the normal to the point internal junction fi over its entire length, and devoid of any straight portion forming a purely radial recess.

Furthermore, the angular coverage of the contact interface 11 between the first and the second end portion 10A, 10B, measured in the projection plane P and corresponding to the angle formed between two secant lines passing respectively through the mean axis the extension (XX ') and each of the inner and outer junction points 01 and 02 is substantially between 5 ° and 120 °. B70450 / FR 17 Thus, the area of overlap between the first and the second end portion 10A, 10B preferably extends substantially over 1.5% to 35 of the total length of the clamping chamber 10, that is, say the perimeter of the loop.

Advantageously, the quantitative importance of the superposition length between the first and second ends 4, 5 improves the stability of the ring and coincides with low values of angle beak a which are most conducive to the proper performance of the functions of Atraumatic adaptation of the contour C by crushing and / or sliding as described above.

Furthermore, according to a preferred embodiment, the clamping chamber or chambers 10, 12 are preformed by construction to occupy at rest a state corresponding to the smallest internal diameter of the loop.

In other words, such preformed clamping chambers are intended to be filled with filling fluid at an equilibrium pressure which allows them to regain their nominal shape, and not overpressure inducing an elastic deformation, or plastic, of the membrane that delimits them. Of course, such an alternative embodiment is particularly reliable and durable since it minimizes the stresses exerted inside the clamping chambers 10, 12 and limits the appearance of leaks.

In addition, the inclined arrangement of the first and second end portions 10A, 10B advantageously guarantees the practitioner that, even if the chambers are underfilled, the contour C delimited by the flexible band 2 remains substantially continuous, and more particularly B70450 / FR 18 devoid of radial detachments that may pinch or alter the stomach membrane.

Thus, the surgical ring 1 in accordance with the invention advantageously guarantees, thanks to a specific cut of its ends 4, 5 not forming a separation primer capable of offering separation, the quasi-continuity of the contour C that delimits around the organ, thus preserving its atraumatic character regardless of the filling level of his or her clamping chambers.

In addition, such a ring has a particularly simple structure, relatively easy to handle and set up within the patient, the particular shape of the ends intended to abut against each other providing as such points of effective and stable markers and also acting detractor to prevent any mis-positioning of the ring within the patient.

Furthermore, in these preferred embodiments, the ring 1 according to the invention also has excellent stability once implanted and a particularly high durability. B70450 / EN

Claims (4)

1 - Surgical ring (1) intended to be implanted in the body of a patient around a biological organ (3) constituting a pocket or a duct for modifying the passage section of said organ when it is enclosed by the ring , said ring (1) being formed by a flexible band (2) intended to be closed on itself to form a closed loop, said flexible band (2) having at least one annular clamping chamber (10) designed to contain a filling fluid and provided at its ends with a first end portion (10A) and a second end portion (10B) which are arranged to come into contact with each other when the flexible band (2) is closed on itself, said ring (1) being characterized in that the first and second end portions (10A, 10B) are inclined with respect to the mean longitudinal extension surface (E) of the flexible band (2) so that to overlap on at least a portion of the contour (C) that delimits said flexible band (2) around the member (3). 2 - Surgical ring according to claim 1 characterized in that the clamping chamber (10) is delimited by an inner wall (15) which is intended to come into contact with the member (3) to be clamped and which joins the first portion extremal (10A) within the loop at an edge (20) at a beak angle (a) substantially between 5 ° and 85 °, and preferably substantially less than or equal to 45 °. 3 - Surgical ring according to claim 1 or 2 characterized in that the first and / or the second end portion (10A, 10B) are at least partly curved. B70450 / FR 20 4 - Surgical ring according to claim 3 characterized in that the first and / or the second end portion (10A, 10B) have a generally concave shape vis-à-vis the inside of the ring. Surgical ring according to claim 3 or 4, characterized in that the radius of curvature of the first and / or second end portion (10A, 10B) is substantially constant. 6 - Surgical ring according to one of the preceding claims characterized in that the first end portion (10A) and the second end portion (10B) have conjugate forms. 7 - Surgical ring according to one of the preceding claims characterized in that the inclination of the first and / or the second end portion (10A, 10B) is maintained right through the transverse section of the clamping chamber ( 10). 8 - Surgical ring according to one of the preceding claims characterized in that it comprises at least two clamping chambers (10, 12) staggered axially and in that the first respective end portions (10A, 12A) of the clamping chambers ( 10, 12) have substantially similar profiles. 9 - Surgical ring according to one of the preceding claims characterized in that the angular coverage (f3) of the contact interface (11) between the first and the second end portion (10A, 10B) is substantially between 5 ° and 120 °. 10-surgical ring according to one of the preceding claims characterized in that the or the clamping chambers (10, 12) are preformed by construction to occupy at rest a state corresponding to the smallest inner diameter of the loop. B70450 / EN