Device for explorable stomach gastric bypass

Abstract

The present invention relates to a device for implementing an explorable stomach gastric bypass apt to be implanted in a patient who needs it. In particular, such device comprises a main body having at least one elastic portion made of silicone material and a covering element of the main body itself that in turn comprises an extensible portion. The extensible portion is positioned at the elastic portion and characterizes in that it comprises an excess of material compared to the size of the elastic portion itself.

Claims

1. A device for carrying out explorable stomach gastric bypass, wherein said device is adapted to be implanted in a patient, comprising: a main body having a first end and a second end and comprising at least one elastic portion made of silicone material, and a covering element comprising an extensible portion along a direction of longitudinal development of the device and positioned at said at least one elastic portion, said extensible portion comprising an excess of material compared to that needed to coat the entire elastic portion, the excess of material having an accordion-like configuration; wherein said device is reversibly extendible.

2. The device of claim 1, wherein said silicone material has a modulus of elasticity between 130 GPa and 170 GPa.

3. The device of claim 1, wherein said covering element comprises polytetrafluoroethylene.

4. The device of claim 1, wherein said extensible portion comprises folds.

5. The device of claim 1, wherein said first end and said second end comprise positioning means.

6. The device of claim 1, wherein the device is adapted to be positionable: in a first non-operative position in which said first end and said second end are not in contact with each other, and in a second operative position in which said first end and said second end are placed in contact with each other such that said device has a substantially circular closed conformation.

7. The device of claim 6, wherein said device has a length of 120 mm when in the first non-operative position.

8. The device of claim 6, wherein said circular closed conformation has a minimum diameter between 15 mm and 18 mm when the device is in the second operative position.

9. The device of claim 6, wherein said circular closed conformation has a maximum diameter between 22 mm and 25 mm when the device is in the second operative position.

10. The device of claim 1 further comprising reference elements that indicate contact between the first end and the second end.

11. The device of claim 10, wherein said reference elements are spaced apart by 5 mm along the direction of longitudinal development.

12. A surgical method for gastric bypass, with explorable stomach remaining excluded, the method comprising: positioning a device below a gastro jejunal anastomosis; and closing the device in an operative conformation; wherein the device comprises: a main body having a first end and a second end, said main body comprising at least one elastic portion made of silicone material, and a covering element of said main body comprising an extensible portion along a direction of longitudinal development of the device and positioned at said at least one elastic portion, said extensible portion comprising an excess of material compared to that needed to coat the entire elastic portion; and wherein said device is reversibly extendible.

13. A device for carrying out explorable stomach gastric bypass, wherein said device is adapted to be implanted in a patient, comprising: a main body having a first end and a second end comprising at least one elastic portion comprising silicone material, and a non-elastic covering element comprising an extensible portion along a direction of longitudinal development of the device configured to surround the entire main body, said extensible portion comprising an excess of material compared to that needed to coat the entire elastic portion; wherein said device is reversibly extendible.

14. The device of claim 13, wherein said silicone material has a modulus of elasticity between 130 GPa and 170 GPa.

15. The device of claim 13, wherein said covering element comprises polytetrafluoroethylene.

16. The device of claim 13, wherein said extensible portion comprises folds.

17. The device of claim 13, wherein said first end and said second end comprise positioning means.

18. The device of claim 13, wherein the device is adapted to be positionable: in a first non-operative position in which said first end and said second end are not in contact with each other, and in a second operative position in which said first end and said second end are placed in contact with each other such that said device has a substantially circular closed conformation.

19. The device of claim 13, further comprising reference elements that indicate contact between the first end and the second end.

Description

DESCRIPTION OF THE FIGURES

(1) FIG. 1 shows a scheme of an embodiment of the device of the invention;

(2) FIGS. 2A and 2B show an embodiment of the device of the invention in a not operative position;

(3) FIGS. 3A and 3B show in schematic form an embodiment of the device of the invention in an operative position, in presence and absence of an endoscopic probe respectively;

(4) FIG. 4 shows an embodiment of the herein described device wherein the point of positioning the Dual Component Bandage (D.C.B) of the invention is represented.

DETAILED DESCRIPTION OF THE INVENTION

(5) The present description relates to a device 1 for carrying out an explorable gastric bypass with excluded stomach apt to be implanted in a patient who needs it (FIG. 1).

(6) In particular, under the term gastric bypass in the present description a technique of bariatric surgery is meant, substantially consisting in creating a gastric pocket which is connected to a jejunal loop in order to avoid the passage of the bolus and the alimentary liquids in the stomach and the duodenum.

(7) The device 1 of the invention actually is a medical device suitable to create a gastric pocket in a method of gastric bypass with explorable stomach. In particular, as shown in FIG. 1, the device comprises a main body 2 an a covering element 5 of the main body itself 2.

(8) The main body 2, as shown in FIGS. 1-4, has a mainly longitudinal development wherein a first end 3 and a second end 4 can be distinguished. The length of the main body 2, and therefore of the device 1, could vary depending upon the operating needs of the surgeon performing the gastric bypass with explorable stomach such as, for example, the width of the stomach walls and the quantity and thickness of the adjacent fat. Preferably, the main body 2 has a longitudinal development of 120 mm.

(9) The main body 2 comprises at least an elastic portion made of silicone material. Preferably, the elastic portion mainly constitutes the central portion of the device 1. In a preferred embodiment of the invention, the main body 2 is entirely made of silicone material. By way of example and not with limitative purpose, the silicone material thereof the elastic portion is partially or entirely made, can be implantable USP Class VI and/or ISO 10993 the features of physiologically inert material thereof allow the biocompatibility with biological tissues.

(10) In an embodiment of the invention the silicone material has a coefficient of elasticity between 130-170 GPa. In other words, the device 1 could comprise at least an elastic portion with a coefficient of elasticity of 130, 135, 140, 145, 150, 155, 160, 170 GPa. In particular, the silicone material with such range of elasticity demonstrated to be particularly suitable to guarantee the passage of an endoscopic probe by exerting a minimum pressure by the operator and, on the other side, the re-activation of the orifice closing after extracting the probe itself.

(11) The main body 2 is coated with a covering element 5, preferably made of biocompatible material, which is integral thereto at least at two ends 3 and 4. In particular, the covering element 5 comprises an extensible portion 6 along the direction of longitudinal development of the device 1 and positioned at the elastic portion of the main body 2, as shown by way of example in FIG. 1. Such extensible portion is made of biocompatible and not elastic material. In the specific case, the portion 6 is made extensible due to the fact that it comprises excess material compared to that needed to coat the entire elastic portion of the main body 2. In other words, then, the extensible portion 6 comprises a greater quantity of material than that needed to coat the elastic portion. By way of example and not with limitative purpose, the extensible portion 6 could have folds, be pre-formed, for example, like an accordion as schematically represented in FIG. 1.

(12) In a preferred embodiment of the present invention the covering element 5 comprises or is made of polytetrafluoroethylene.

(13) As shown in FIGS. 2A and 2B, the device 1 can be present in a first not operative conformation/position in which the first end 3 and the second end 4 are not in contact with each other. As it is clear from the figures, in said first position the device 1 actually is an open system in which the two ends 3, 4 are in continuity only on one side thereof. In an embodiment of the invention, the length of the device 1 in said first position is about 120 mm.

(14) Alternatively, the device 1 can be positioned according to an operative conformation in which the first end 3 and the second end 4 are in contact. In other words, in such second position the device forms a closed system as sketched in FIGS. 3 and 4.

(15) In particular, during the surgical operation of gastric bypass with explorable stomach, the positioning of the device 1 below the gastro-jejunual anastomosis and the passage from the first not operative position to the second operative position will allow creating the gastric pocket, by delimiting the same.

(16) In order to allow the positioning of the device 1 according to the operative conformation, the first end 3 and the second end 4 can comprise positioning means. Under positioning means in the present invention means are meant suitable to allow a preferably stable and long lasting contact between the two ends 3, 4. By purely way of example and not with limitative purpose, such positioning means can comprise tongue-and-groove systems.

(17) In the embodiment in which the device 1 has no positioning means, the second operative position can be however obtained by stitching the two ends 3, 4, for example, by using a surgical linear stitching machine or a not re-absorbable metallic clip.

(18) Furthermore, in order to favour the surgeon in closing the device 1, the first end 3 and the second end 4, as shown in FIGS. 2A and 2B, can be equipped with holes 9 for the passage of threads or surgical instruments facilitating the traction of the device 1.

(19) Preferably, when the device 1 is in the operative position, it forms a closed system with a substantially circular conformation, whose minimum diameter is comprised between 15-18 mm. Operatively, such minimum diameter characterizes the device 1 in the operative conformation in absence of endoscopic probes or other surgical/diagnostic instruments inside the gastric lumen, as shown in FIG. 4.

(20) As already mentioned above, the device 1 of the invention, allows being able to perform successfully an operation of gastric bypass with stomach remaining excluded with diagnostic and/or operative possibilities. Therefore, when the device is in said operative position, it allows the passage of an endoscopic probe thanks to the fact that the main body 2 comprises an elastic portion the extension thereof can be followed by the covering element 5 which comprises an extensible portion 6. In this regard, for example, after the insertion of an endoscopic probe, a lengthening of the device 1 can be provided and, in particular, a lengthening of the elastic portion of the main body by 25% with respect to the length of the device 1 in the operative conformation established by the surgeon as suitable, for a given patient, to prevent the passage of the alimentary bolus in the stomach remaining excluded.

(21) In an embodiment, in presence of an endoscopic probe or however any other instrument considered suitable to perform a scanning for diagnostic and/or operative purposes of the stomach remaining excluded, the closed conformation substantially with circular shape of the device 1 can reach a maximum diameter between 22-25 mm.

(22) Furthermore, the device 1 can even comprise reference elements 8 apt to signal to the surgeon the points of potential contact between said first and second end 3, 4. In other words, the presence of said reference elements 8 allows varying the diameter of the circular closed conformation (device in the operative position) during implant. In particular, such reference points 8 favour the positioning of the device 1 in the operative position. In an embodiment of the invention said reference elements 8 are spaced by 5 mm. By way of example, as shown in FIGS. 1-4, such reference elements 8 can be shaped like notches or lines perpendicular to the longitudinal axis of the device 1, in case with different colours. By way of example and not with limitative purpose, the reference elements 8 can be provided under the form of two outer notches, each one on each end 3 or 4, at a distance of about 100 mm, two inner notches spaced apart by about 40 mm, and pairs of intermediate notches spaced apart each one by 50, 60, 70, 80, 90 mm.

(23) The device of the invention can be implemented with any technique considered suitable by the person skilled in the art. By way of example and not with limitative purpose, the device 1 can be implemented by RTV (Room Temperature Vulcanisation) or HTV (High Temperature Vulcanisation) printing and vulcanisation in a single body and a single size.

(24) Herein even a surgical method for carrying out a gastric bypass with explorable stomach remaining excluded using the device 1 of the invention is also described. In particular, such surgical method of gastric bypass with explorable stomach remaining excluded characterizes for a series of operative passages thereamong a passage of positioning the device 1 below the gastro-jejeunal anastomosis and closing the same in an operative conformation in a way analogous to what already described above.

(25) Preferably the device 1 will be positioned at about 1-2 cm below the gastro-jejeunal anastomosis which has its cranial apex at about 2-3 cm from the cardia. In particular, then in an embodiment of the here described surgical method a gastric pocket with the sizes of about 53 cm and a capacity of about 30 ml is created.

(26) The method could further comprise a passage of removing the gastric bottom portion. Advantageously, the removal of the gastric bottom portion is associated to a not secretion of the orectic ghrelin hormone with consequent appetite decrease of the patient.

(27) In an embodiment, the above method is implemented by means of laparoscopy.

(28) Mode of Implanting an Embodiment of the Device 1

(29) The device 1 with its coating made of PTFE (polytetrafluoroethylene) is passed under the gastric tubule, containing inside a gastric probe with a diameter of 12 mm, and grasped at the two ends, preferably shaped like a semi-ellipse for an easy grasp, and then pulled upwards with a thread passing forceps inserted in the suitable small holes 9 with diameter of about 3 mm existing at the ends. At this point a Johan forceps grasps the device, following the reference elements 8 and closes it around the gastric tubule without exerting any pressure. This is then the co-called outer opening circumference of the neo-gastric tubule with the inserted probe (C.A) (FIG. 3A). At this point, depending upon the C.A. size obtained by the corresponding reference elements 8, the surgeon, once the gastric probe is made to be withdrawn by the anaesthetist, will pull the device 1 so that in the definite closing it scales down by four reference elements 8 inwards, by obtaining in this way an outer closing circumference (C.C.) smaller by 40 mm than the opening one. The 40 mm of shortening the circumference are determined by 30 mm corresponding to the gauge of the gastric probe and by 10 mm needed to the silicone lengthening to exert an adequate closing of the gastric tubule). The final length of the device 1n in its closed operative conformation (C.C) usually varied from 50 to 70 mm with a minimum diameter of 15-18 mm and a maximum diameter of 22-25 mm.
The silicone compression elastic force, after shortening by 10 mm, is related to a lengthening of about 25% in the extensible area needed to occlude the gastric lumen below the anastomosis in the point of applying the device 1 so as to prevent the passage of the liquids and/or the alimentary bolus from the gastric pocket to the gastric cavity.
The device, during implant, can be closed with a metallic clip or even better with a stroke of linear stitching machine.

(30) The present invention has been so far described by referring to the preferred embodiments thereof. It is to be means that other embodiments belonging to the same inventive core may exist, all belonging to the protection scope of the here-below reported claims.