Gastric calibration band

Abstract

The invention relates to a non-inflatable gastric band (1) including two end areas (2, 3) and an intermediate portion (4). The inner surface (I) of the band (1) is intended to contact the stomach. The end areas (2, 3) are provided with complementary closing means (5, 6) selected from notches (5) and locking loops (6) that are mutually engageable so as to ensure that the band (1) is locked in a closed position. The end area (2) has at least one notch (5) and is intended to be inserted through at least one locking loop (6) placed on the outer surface of the end area (3) up to a locked closed position, wherein at least one notch (5) is moved beyond a locking loop (6). The end area (3) also includes a guide loop (7).

Claims

1. Non-inflatable gastric band made in one piece of molded elastomer, the gastric band comprising an end area with notch(es), an end area with loop(s), and an intermediate portion with a solid cross section situated between the two end areas, the gastric band having an inner surface-linked to an outer surface of the gastric band by two edges and wherein the inner surface is intended to come into contact with a part of a stomach encircled by the gastric band, the two end areas being equipped respectively with complementary closing means capable of cooperating with each other in order to ensure a locking in a closed position of the gastric band, the closing means of the gastric band including at least one notch on the end area with notch(es) and at least one locking loop on an outer surface of the end area with loop(s), the at least one locking loop being integral with the end area with loop(s), wherein the end area with notch(es) is intended to be inserted through the at least one locking loop arranged on the end area with loop(s) up to the locked closed position in which the at least one notch is moved beyond the at least one locking loop, the end area with notch(es) including a terminal tongue arranged substantially in a plane of the gastric band between parallel longitudinal edges, and at least two adjacent enlarged portions projecting with respect to the longitudinal edges of the terminal tongue, each of the adjacent enlarged portions having a width measured in a plane of the gastric band, the at least one notch being formed between the at least two adjacent enlarged portions, wherein the end area with the loop(s) also comprises at least one guide loop arranged on the outer surface of the end area with loops(s) and integral with the end area with loop(s), the at least one guide loop defining a passage for the at least one notch, the at least one guide loop forming of an arch having dimensions that are too large to allow an anti-reverse locking of the at least one notch, and greater than dimensions of a passage defined by the at least one locking loop, the at least one guide loop having a width equal to the width of the at least two adjacent enlarged portions, the at least one guide loop being closer to a free end of the end area with loop(s) than the at least one locking loop, so that during closing and locking of the gastric band, the at least one notch passes through the at least one guide loop before passing through the at least one locking loop.

2. Gastric band according to claim 1 in which, in the closed position of the gastric band, the end area with notch(es) and the end area with loop(s) overlap at least partially, and in which the end area with loop(s) is bevelled in thickness.

3. Gastric band according to claim 2, in which the free end of the end area with loop(s) is thinner than a remainder of the end area with loop(s).

4. Gastric band according to claim 2, in which the end area with notch(es) is bevelled in thickness.

5. Gastric band according to claim 4, in which the end area with notch(es) and the end area with loop(s) are bevelled in a complementary manner in the closed position of the gastric band.

6. Gastric band according to claim 4, in which the end area with notch(es) has a free end thinner than a remainder of the end area with notch(es).

7. Gastric band according to claim 4, in which a thickness of the end area with notch(es) is bevelled in a longitudinal direction of the band.

8. Gastric band according to claim 2 in which, in the closed position of the gastric band, the end area with notch(es) at least partially overlaps the end area with loop(s), an inner surface of the end area with loop(s) forming a part of the inner surface of the band intended to be in contact with the stomach.

9. Gastric band according to claim 2, in which an angle of a bevel between an inner surface and an outer surface of the bevelled end area is comprised between 0.1 and 10.

10. Gastric band according to claim 2, in which a thickness of the end area with loop(s) is bevelled in a longitudinal direction of the gastric band.

11. Gastric band according to claim 2, in which an angle of the bevel between an inner surface and an outer surface of the bevelled end area is comprised between 0.5 and 8.

12. Gastric band according to claim 2, in which an angle of the bevel between an inner surface and an outer surface of the bevelled end area is comprised between 1 and 5.

13. Gastric band according to claim 1, in which the end area with notch(es) comprises a terminal part interposed between a part comprising the at least one notch and the intermediate portion, the terminal part having a width equal to the width of the at least one notch.

14. Gastric band according to claim 1, comprising at least one radio-opaque part.

15. Gastric band according to claim 14, wherein the at least one radio-opaque part is borne by the outer surface of the gastric band.

16. Gastric band according to claim 1, comprising at least one projection for endoscopic handling.

17. Gastric band according to claim 16, wherein the at least one projection for endoscopic handling comprises at least two projections for endoscopic handling.

18. Gastric band according to claim 17, wherein each of the two projections extends from one of the edges of the gastric band.

19. Gastric band according to claim 16, wherein the at least one projection for endoscopic handling is located at the end area with loop(s).

Description

DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

(1) Other notable features will become apparent from the following description of a preferred embodiment of the band according to the invention.

(2) This detailed description is given with reference to the attached figures in which:

(3) FIG. 1 represents a perspective view of the band according to the invention, not closed.

(4) FIGS. 2 and 3 represent side views of the band according to the invention, in the open and closed/locked positions respectively at the level of the first notch.

(5) FIG. 3A is a detailed view of the band of FIG. 3.

(6) FIG. 3B is a variant of FIG. 3 closed/locked at the maximum level of the third notch.

(7) FIG. 4 is a detail of FIG. 2 (circle V of FIG. 2) showing in side view the bevelled end area with notches.

(8) FIG. 5 is a detail of FIG. 3 (circle IV of FIG. 3) showing in side view the bevelled bearing end area with loop(s).

(9) FIG. 6 is a top view of a variant of FIG. 2.

(10) As shown in the attached figures, the band (1) according to the invention is a gastric band intended to encircle and calibrate a part of the stomach with which it comes into contact via its inner surface (I).

(11) This flexible, non-inflatable band (1), e.g. produced by moulding an elastomer such as a silicone elastomer, has an inner surface (I) intended to come into contact with the stomach and linked by two edges (B1,B2) to an outer surface (E). It comprises: a so-called end area with notches (2), the free end (9) of which has an extension formed by a tongue (10) having three notches (5), respectively (5.3-5.2-5.1) from the base towards the end of the tongue (10); an end area (3) provided with a locking loop (6) and a guide loop (7) which extend in a direction substantially perpendicular to the outer surface of this so-called end area with loops (3); an intermediate portion (4) situated between the two end areas (2) and (3) which are two extensions of this intermediate portion (4); the outer surface (E) of this intermediate portion (4) being covered with a radio-opaque insert (14).

(12) The two end areas (2) and (3), the tongue (10) and the intermediate portion (4) have a solid cross section. The three notches (5) and the loops (6, 7) of this band (1) of substantially rectangular, straight cross section, are complementary closing means (5, 6) capable of cooperating with each other to ensure the closing and locking in the closed position of the band (1) formed by bringing the two end areas (2) and (3) towards each other.

(13) The three notches (5.1-5.2-5.3) are triangular extensions of the edges of the tongue (10) in the plane of the latter, parallel to or in the plane (x.sub.B;y.sub.B) defined by the three-dimensional frame of reference (x.sub.B;y.sub.B;z.sub.B) of FIG. 1. These three notches (5.1-5.2-5.3) are, in this embodiment example, of identical shapes and dimensions. But it could be otherwise.

(14) The end area (2) with notches (5) is divided into two parts: a terminal part (20) delimited by the free end (9) and by a shoulder (11) and a linking part (21) extending between the shoulder (11) and the join between the end area (2) with notches and the intermediate portion (4).

(15) An extra thickness (12) for reinforcement extends from the terminal part (20) of the end area (2) with notches, over the outer surface of the tongue (10).

(16) On the outer surface of the end area (3) with loops, the guide loop (7) is closer to the free end (8) of the end area (3), than the locking loop (6). The locking loop (6) is situated in the vicinity of the top of the slope of the bevel of the end area (3) with loops, this top being itself substantially at the join between the end area (3) with loops and the intermediate portion (4).

(17) Moreover, the cross-sectional area of the guide loop (7) of the band (1) is greater than that of the locking loop (6). The same applies to the widths of these loops along the axis (y.sub.A) defined by the three-dimensional frame of reference (x.sub.A;y.sub.A;z.sub.A) of FIG. 1.

(18) As shown by FIGS. 1 and 6, the band (1) has two projections (13)or lobesfor endoscopic handling, each extending from an edge (B1, B2) of the end area (3) with loops. These lobes 13 are situated in the plane (x.sub.A,y.sub.A) of the width of the band (1).

(19) In this preferred embodiment of the band (1) according to the invention, the two end areas (2) and (3) of the band are bevelled in their thickness, along the longitudinal direction given by the axis (x.sub.B),(x.sub.A), so that this thickness gradually decreases from the join between the end area (2),(3) and the intermediate portion (4) towards the free end (8),(9).

(20) The bevel of the end area (2) with notches can be defined by the angle .sub.B between its inner surface and its outer surface which is only an extension of the outer surface (E) of the band (1) in the closed and locked position of the latter. The angle .sub.B which appears in FIG. 4 is comprised between 1 and 5, for example 4 in this case.

(21) The bevel of the end area (3) with loops can be defined by the angle .sub.A between its outer surface bearing the loops (6, 7) and its inner surface which is an integral part of the inner surface (I) of the band (1) in the closed and locked position of the latter. The angle .sub.A which appears in FIG. 5 is comprised between 1 and 5, for example 4 in this case.

(22) Preferably, .sub.B=.sub.A for the overlapping to be complementary. These bevels serve to improve and facilitate the closing of the band around the stomach.

(23) In FIG. 1, the radio-opaque insert (14) is formed by two parallel borders (15, 16), proud of the surface (E) and linked by 3 c (17). It is constituted for example by a elastomer of the same type or not of the same type as the band (1).

(24) As shown in FIGS. 1 and 2, the band is pre-formed so that when disengaged, i.e. not closed/locked, it is essentially curved in its intermediate portion (4)for example over an angular sector comprised between 150 and 270-225 in this casewhereas the end area (3) with loops, the end area (2) with notches and its notched tongue extending the latter, are substantially straight.

(25) This curved pre-form makes it possible to facilitate the closing of the band around the stomach, in particular by limiting the surgeon's movements. Furthermore, the end area (3) bearing at least one loop (6) is straight and the cross-sectional areas of the guide loop (7) and of the locking loop (6) are aligned along the same axis, the longitudinal axis x.sub.A of the band. The tongue or extension bearing at least one notch is passed through the guide loop and the locking loop in a single movement by the surgeon, thus limiting the latter's movements and the operating time.

(26) FIGS. 3A and 3B show respectively a locking with the notch (5.1)closest to the end of the tongue (10)and with the third notch (5.3)closest to the free end (9) of the area (2) with notches.

(27) In the position of FIG. 3B, the third notch (5.3) is passed through the locking loop (6) and its base is supported on the surface of the loop (6) turned towards the intermediate portion (4) and the free end (9) butts up against the face of the loop (6) turned towards the guide loop (7).

(28) Moreover, the shoulder (11) between the parts (20) and (21) of the area (2) with notches, butts up against the face of the guide loop (7) turned towards the free end (8) of the area (3) with loops.

(29) Thus, the band can be closed/locked in a simple, safe, stable and atraumatic manner, around the stomach. In fact, angular displacements of the end area bearing at least one notch relative to the end area bearing at least one loop are then impossible. These two end areas remain correctly overlapping and their respective edges remain perfectly parallel.

(30) As shown in FIG. 3, the band in the closed and locked position is substantially circular in side view.

(31) FIGS. 3, 3A and 3B show that the bevels of the respective end areas (2) and (3) have inverse slopes. The end area (2) with notches therefore overlaps the end area (3) with loops in a complementary manner.

(32) The overlapping is greater in the locking with the notch 5.3 of FIG. 3B. This overlapping of the bevels tends to minimize the thickness (axes z.sub.A;z.sub.B in FIG. 1) in this area and limits, or even eliminates, the roughness that can be formed by the free end (8) on the inner surface (I) of the band intended to be in contact with the stomach.

(33) The edges of the band (1) according to the invention are advantageously blunt so as not to injure the patient.

(34) It is provided according to a notable feature of the invention, that the band is in a single piece and is produced from at least one silicone elastomer with a hardness comprised for example between 30 and 80 Shore A, preferably 50-70 Shore A, for example of the order of 60 Shore A.

(35) The band (1) according to the invention can be put in position by conventional surgery or by laparoscopy, around the stomach and more precisely around the portion of the stomach receiving the food bolus, within the context of a by-pass operation, around the proximal stomach pouch. The C-shaped preform and the straight shape of the end areas and of the tongue with notches, as well as the lobes for endoscopic handling (13) are all assets facilitating manipulation of this band (1) by the surgeon.

(36) This band (1) does not require fixing to the stomach, which is another decisive advantage, so as not to add work to the surgery.