MXPA00012606A - Device for reducing the food intake of a patient - Google Patents

Abstract

A food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient, comprises a band (27), and means (41, 43) for forming a loop of the band defining a restriction opening. The band (27) comprises a single elongated closed tubing (29) which is devoid of any longitudinally extending reinforcement means at least along a substantial longitudinal portion of the tubing. Means (35) are provided for inflating and deflating the tubing to adjust the size of said restriction opening. Preferably, the tubing (29) is elastic, whereby the band (27) is extensible.

Description

DEVICE TO REDUCE THE CONSUMPTION OF FOOD OF A PATIENT The present invention relates to a device for restricting the consumption of food to form a stoma opening in the stomach or esophagus of a patient, which comprises a band, and a means for forming a handle of the band defining an opening of the stoma. restriction. 10 In the early years of the 1980s, surgical procedures were frequently carried out to treat overweight patients by placing a band of a food restriction device around the stomach, which formed a restriction, thus preventing the food from passing down, and more correctly reducing the speed and quantity of the food being eaten. After a few years of use of the new surgical method, it became It was evident that it was very difficult to apply the band with an appropriate narrowing, if the band was too tight around the stomach, the patients were affected by vomiting attacks. Alternatively, if the band was too loose, the opening between the parts - "- A« aa- < - "j- - • _--- H - ^ - M-_a upper and lower stomach became too large, resulting in food problems or problems of weight were unaffected. Unfortunately, many of these operations therefore resulted in a failure. The solution to this problem was to provide a band that has an inflatable balloon inside it, equal to a blood pressure meter. This balloon can be connected to an injection hole, making it possible to change the inner diameter of the band after the operation. In this way, if after the operation the band is found to be too tight, it was possible to drain some fluid through the injection hole. This processing increased the opening of the loop or band circuit, resulting in a greater restriction between the upper and lower parts of the stomach. On the other hand, if the patients did not lose weight, it was possible to inject fluid through the injection orifice, thereby narrowing the restriction between the upper and lower parts of the stomach (the "stoma diameter"). This operation was ^ ^ clearly better than the previous method, but unfortunately this operation was not free of problems. Specifically, there were three main difficulties. 5 First, the loop band has a tendency to dislocate toward the lower part of the stomach. This could be prevented by suturing the lower part of the stomach to the upper part of the stomach (the so-called "tunnel formation"). prevent the band from dislocating downward toward the main curvature of the stomach. However, sometimes these sutures broke, thus negatively affecting a desired long-term weight loss. 15 The second difficulty, revealed by a recent investigation, was that the upper part of the stomach rapidly increased in size, up to approximately ten times its original size, resulting in a reduction in the weight loss. The third difficulty was that the previous band tended to migrate through the wall of the stomach. An object of the present invention is provide a restriction device of and t +? d & w "." ..,. . . . . . ,. . ,. . . • , • ".. .. ...,. " ^ .y; ,, -tm ^ food consumption, substantially non-pressurized, reliable, simple to reduce a patient's food intake. Another object of the present invention is to provide a food consumption restriction device in which the web is designed to minimize the risk of the web migrating through the stomach wall. These objects are achieved by a restriction device for food consumption of the kind initially indicated, characterized in that the band comprises an elongated closed pipeline., which is lacking any means of reinforcement, extending longitudinally, at least along a substantial longitudinal portion of the pipe, and wherein means are provided for inflating and deflating the pipe to adjust the size of the pipe. the restriction opening. As a result, at least a substantial portion of the band lacks any hard, reinforcing outer wall that can damage the stomach. This is of particular advantage when the band is surrounding the stomach wall portions due to the sutures of the tunnel formation. To achieve the necessary adjustment of the size of the restriction opening, the pipe is simply designed sufficiently wide to expand sufficiently from a flattened state of a radially inward form of the circuit or handle. In addition, a wide pipeline is beneficial with respect to the large surface area of the pipe that will be in contact with the stomach. The circumferential wall of the pipe may be flexible, and it is preferred that it be elastic, whereby the band is extensible. As a result, the extendable band is capable of longitudinally forming to allow large, accidental pieces of food to pass through the restriction opening. Additionally, the circumferential, elastic wall of the band is capable of flexing radially under the influence of dynamic movements of the stomach, ie, the stomach has a certain freedom to move where it is in. contact with the band, or that significantly reduces the risk of the band flexing or migrating through the wall of the stomach. If the stomach wall is prevented from moving along the region where the band makes contact with the stomach, the stomach wall will reach MÍtflHÍM-MMH -it hÉÉfa * ü to be thinner over time, which dramatically increases the risk of the band penetrating the wall of the stomach. In this way, the elastic characteristics of the band of the food consumption restriction device of the invention results in a more natural cooperation between the band and the stomach, ie, the muscle of the stomach wall is allowed to move appropriately in a physiological sense. The thickness of the circumferential wall of the pipe may suitably vary, in a preferably continuous manner, in the circumferential direction, so that two opposite axially extending portions of the circumferential wall differ in thickness. As a result, a relatively large inward expansion of the pipe is achieved when the band is inflated. The thinner of the two opposite axially extending portions can be suitably designed to form a row of protuberances along the strip, when the pipe is at least partially filled with fluid. This gives the advantage that the formation of bends on the inner side of the pipe is prevented as the band is bent towards a handle or dM ^? i É circuit, which dramatically increases the life time of the band. Additionally, the folds developed in the wall of the stomach along the band are distributed in the cavities formed between the adjacent protuberances which is beneficial in a physiological sense. As an alternative, this row of protuberances can also be designed in a pipe having a uniform wall thickness. Alternatively, or in combination with a variable wall thickness, the same result is achieved by designing two axially extending wall portions with different elasticity, whereby the more elastic portion is located on the inner side of the circuit or band handle. Advantageously, one of the two opposite axially extending portions of the circumferential elastic wall, which is proposed to form the inner side of the band circuit, can be pre-tensioned. The means for forming a handle or circuit of the band may comprise two separate fasteners stronger than the pipe secured to the pipe at opposite ends thereof. Alternatively, the fasteners • - - Y -. ,. -, ». Y .. . , ¡-E. ? - ......, .Vi, i .... ÁA. they can form integrable parts in the pipe itself and be of the same material as the pipe. More specifically, the fastening elements can be designed to be joined to each other by suture, connection with press-fit, or the like. The means for inflating and deflating the tubing can stably comprise the fluid dispensing means for adding fluid and removing fluid from the interior of the tubing. The invention is described in more detail in the following with reference to the accompanying drawings, in which: Figure 1 is a perspective view schematically showing a restriction device for food consumption, reinforced in place in the stomach and esophagus after surgical implantation, Figure 2 presents a perspective view, schematic of the device shown in Figure 2, Figure 3 is a view of a band of a first embodiment of the food consumption restriction device according to the present invention, Figure 4 is a cross-sectional section along the the line VV of Figure 3, Figure 5 is a cross section through a modification of the band shown in Figure 3 and forming a handle or circuit, Figure 6 is a cross section through another modification of the band shown in Figure 3 and forming a handle or circuit, and Figures 7 and 8 are a front view and a side view, respectively, of a band of a second embodiment of the food consumption restriction device according to the invention. present invention. A reinforced food consumption restriction device, which is the subject of U.S. Patent Application Serial No. 532,357 filed in 1995, now U.S. Patent No. 5,771,903, is now described with reference to the Figures 1 and 2. This device comprises a band 11 having an elongated supporting outer wall, spaced 13 from a substantially non-expandable and flexible material. The wall 13 is preferably made of a reinforced plastic and / or silicone material having such flexibility that it can be bent to form a loop or loop defining a restriction opening. The band 11 has a length that allows the loop or loop of the band to form around the esophagus and / or stomach, and which allows an anterior superior part of the stomach wall to pull through the circuit to form a pocket small 5 of the stomach. The ends 15, 17 of the outer wall 13 can be joined together, for example, by suture, by a pressurized safety connection, or by any other suitable joining means. The strip 11 has a bottom wall 19 made of a soft plastic material, and / or of silicone, elastic. This inner wall 19 is glued or heat sealed to the outer wall 13, thereby providing an expandable cavity between the walls 13, 19. The lateral extension of the elongated inner wall 19 in a fully adequate state is more than 20 mm and less than 40 mm, while the lateral extension of the outer wall 13 is approximately 13 mm. Fluid supply means are provided to add fluid and remove fluid from the cavity to extend the flexible inner wall 19 to decrease the size of the restriction opening and deflate the flexible inner wall -_----- h ------- SUriáÉ-a ?? t- 19 to increase the size of the restriction opening. The fluid supply means comprises an injection orifice 23 and a flexible conduit 21 which connects the injection orifice 23 to the cavity. The injection orifice 23 is implanted in a region easily accessible in the patient, it is preferably placed subcutaneously against the lower part of the sternum 8, thereby providing a support for the patient. injection hole 23 during the addition of fluid. The flexible product 21, which is made of a silicone rubber tube, has a length such that when the band 11 is applied to the stomach and the injection hole 23 is implanted against the sternum 8, the duct 21 extends downwards from both the band 11 and the sternum 8 to form an open circuit between them. The inner wall of the band 19 can extend inward from the outer wall 13 adjacent to a degree such that when a circuit or band loop has been formed, the opening of the circuit will be substantially obstructed. Normally, a non-extended circuit has an inner diameter of approximately 35 mm. 25 Band 11 varies in width throughout its S & amp; ??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? esophagus-cardia junction, or on the posterior surface of the cardia. In this way, the surface pressure against the wall of the esophagus 3 (or alternatively, in the posterior part of the esophago-cardia junction, or in the posterior surface of the cardia) will be reduced, thus decreasing the stress per unit area placed on the wall of esophagus 3 (or alternatively, at the posterior part of the esophago-cardia junction, or on the posterior surface of the cardia) through the band 11. The wide range of adjustment of the cavity or the inner wall 19 is a very important characteristic of the band 11 to achieve a satisfactory long-term result. Figure 3 shows a band 27 of one embodiment of the food consumption restriction device of the present invention, to form a stoma opening in the stomach or esophagus of a patient, having similar components to those of the device shown in Figure 2, except that band 27 is designed in a different way. The band 27 includes an elongated pipe 29 having a circumferential wall 31 of a homogenous, elastic material. The line 29 5 defines a closed cavity 33 with an inlet 35 for the supply of a fluid, preferably liquid. The circumferential wall 31 has a relatively thin axially extending portion 37 and a portion 39 that is extends axially, relatively thick positioned opposite to it. The band 27 is provided with two interconnectable fastening elements 41 and 43 to form a circuit of the band 27 defining a restriction opening. The elements of fastening 41, 43 comprise terminal fins formed as integral parts of the pipe 29 itself and are of the same material as the pipe 29. As an alternative, the circumferential wall 31 of the pipe 29 may be of an foldable material and is not necessarily elastic. Figure 5 shows the strip 45 having similar components as those of the strip 27 shown in Figure 3 except that the thin portion 37 of the circumferential wall 31 is designed differently. The two fastening elements The strip 45 is interconnected, so that the strip 45 forms a circuit with the thin portion 37 of the wall 31 extending further inward along the circuit and consequently, with the thick portion 39 extending further outwards along the circuit. The thin portion 37 is designed to form a row of protrusion 47 that includes at least three protuberances 47, here there are five protuberances 47, along the band 45. The protuberances 47 extend completely and the adjacent protuberances 47 separate from each other when the cavity 33 of the band 45 is filled with fluid. Figure 6 shows a band 49 having similar components as that of the band 45 except that the circumferential wall 31 is uniformly thick and is designed to form a number of spherical portions 51 interconnected but separated, here five portions 51, as length of band 49. Figures 7 and 8 show a band 59 of another embodiment of the food consumption restriction device of the present invention having components similar to those of the device described above in conjunction with Figures 3 and 4, .ÍÍ-_AÍÜ. ^^ ^^^ Mf ^^^^ & ^ & * ^ & you > except that the means for forming a circuit of the band 59 (the fasteners 41, 43 of the band 27) are designed differently. In this way, two separate fastening elements 61 and 63 stronger than the pipe 29 are secured, for example by glue, welding or the like, to the pipe 29 at opposite ends thereof, leaving a substantial longitudinal portion of the pipe. free pipe 29 between the terminal fins 61, 63. Each fastener element 61, 63 is secures to the same longitudinal side of the pipe 29, so that the opposite or complete longitudinal side of the pipe 29 has a smooth surface suitable for butting against the stomach and / or esophagus. The fastening element 61 is. You can insert into a hole 65 in the another clamping element 63, so that the edge surrounding the hole 65 of the clamping element 63 snaps into the two lateral indentations 67 formed in the clamping element 61. A sleeve 69 extends through the hole 65. and it sticks with glue on an edge surrounding the opening in the pipe 29. A pipe 71 is sealedly attached to the sleeve 69 to distribute fluid to and from the interior of the pipe 29.

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Claims (14)

1. - CLAIMS 1. A device for restricting feed intake to form a stoma opening in the stomach or esophagus of a patient, comprising a band and means for forming a circuit of the band defining a restriction opening, characterized in that the band comprises a single, elongated, closed pipe that is devoid of any reinforcing means that extends longitudinally at least along a substantial longitudinal portion of the pipe, and that means are provided for inflating and deflating the pipe to adjust the size of the restriction opening.
2. 2. A food consumption restriction device according to claim 1, wherein the pipe has a circumferential, foldable wall.
3. 3. A •. The food consumption restriction device according to claim 2, wherein the circumferential wall of the pipe is elastic, whereby it is extensible to the belt.
4. 4. A food consumption restriction device according to any of claims 1-3, wherein the pipeline has a ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
5. 5. A food consumption restriction device according to any of claims 1-4, wherein the pipe has a circumferential wall and the thickness of which varies in the circumferential direction.
6. 6. A food consumption restriction device according to claim 5, wherein the thickness of the circumferential wall of the 10 pipe continuously varies the circumferential direction.
7. 7. A food consumption restriction device according to claim 5, wherein the two portions that extend in a manner 15, opposite "of the circumferential wall differ in thickness
8. 8. A food consumption restriction device according to claim 7, wherein the thinner of the two opposite portions 20 which extend axially from the circumferential wall is designed to form a row of protuberances along the band, when the cavity is at least partially filled with fluid. 25
9. 9. A device for restricting ^^^? ¡^^^^ í¿ ^^, Jt'j "" a- y. i. i. , A * - A & & amp; food consumption according to claim 8, wherein the protrusion of the circumferential wall is separated from each other.
10. 10. A food consumption restriction device according to claim 3, wherein the two axially extending opposed portions of the circumferential wall have different elasticity.
11. 11. A food restriction device according to claim 3, wherein one or both of the opposing axially extending portions of the circumferential wall is pre-tensioned.
12. 12. A food consumption restriction device according to claim 1, wherein the pipe has a circumferential wall and one of the two opposite axially extending portions of the circumferential wall is designed to form a row of protrusions a along the length of the band, when the pipe is at least partially filled with fluid.
13. 13. A food consumption restriction device according to any of the preceding claims, wherein the means for 25 forming a circuit of the band comprises two ^ "^ Separate fastening elements stronger than the pipe secured to the pipe at opposite ends thereof. A food consumption restriction device according to any of the preceding claims, wherein the means for inflating and deflating the tubing comprises a fluid distribution means for adding fluid and removing fluid from the interior of the tubing. ÍÁ. ... ^^ dgg ^ g