Anti-gastroesophageal reflux valvular prosthesis

[0001] The present invention relates to an anti-gastroesophageal reflux valvular prosthesis.

[0002] As is known, the term “hiatal hernia” is used to define a dislocation of an abdominal viscus of the thorax through an aperture in the diaphragm called the hiatoesophageal orifice, normally traversed by the esophagus.

[0003] Through this aperture in the diaphragm the esophagus can abnormally reascend the thorax, determining a sliding (rotational) hernia along with a portion (generally the most proximal portion) of the stomach (cardia).

[0004] The sliding hernia is generally associated with a reflux pathology, that is esophagitis.

[0005] When the border between esophagus and stomach shifts within the territory of the thorax, where the pressures are opposite the abdominal pressures (during inspiration, in the thorax there are negative values and positive ones in the abdomen), the acid content of the stomach lingers a little too long in the last tract of the esophagus and tries to digest the mucosa.

[0006] Eleven percent of the population experiences symptomatic gastroesophageal reflux on a daily basis.

[0007] When gastroesophageal reflux is symptomatic, a pathological entity is always present as a consequence of the reflux, for example esophagitis.

[0008] Recent studies suggest that the increase of esophageal cancer in industrial society may be linked precisely to the columnar transformation of the distal esophageal mucosa as a consequence of chronic reflux.

[0009] To avoid at least somewhat the drawbacks complained of above, medical reflux therapy based on pro-kinetic and antacid agents is applied.

[0010] However, when the aforesaid therapy also fails, surgical intervention is provided, resulting in such anatomical changes as to allow the possible hiatal hernia to be corrected and the anti-reflux mechanism to be improved.

[0011] Nevertheless, the great disadvantage of surgical intervention is that it frequently leads to complications and disorders that are sometimes difficult for the patient to tolerate.

[0012] The object of the present invention is to eliminate the drawbacks of the known technique described above.

[0013] An important object of the invention is to provide an anti-reflux gastroesophageal valvular prosthesis that helps avoid surgical intervention that could make anatomical changes and, consequently, surgical overcorrection that would lead to complications and disorders that the patient cannot tolerate.

[0014] Another object of the invention is to provide a valvular prosthesis that makes it possible to keep the last tract of esophagus in the abdomen by closing the diaphragmatic passage at the same time, surpassing medical reflux therapy and surgical interventions liable to bringing about anatomical changes that the patient cannot tolerate.

[0015] It is also an object of the invention is to provide a prosthesis that acts in a substantially natural manner, so that the more the stomach dilates proximally due to the presence of food and the more the angulation is automatically accentuated, the more the cardiac esophagus and the stomach closes.

[0016] A further object of the invention is to provide a prosthesis that allows coupling with a gastric pacemaker to stimulate the gastric portion of the sphincteral smooth musculature, for example during nightly rest.

[0017] It is also an object of the invention to provide a prosthesis that can be inserted into the abdomen with a laparoscopic or micro invasive technique and that can be removed without a new surgical intervention.

[0018] These objects are achieved with an anti-reflux gastroesophageal valvular prosthesis which comprises a body presenting a seat of substantially semicircular shape, engageable with the gastric wall of the stomach by connectors, and means for inflating at least the body for the variation of its volume to accentuate the angle of His and improve the natural anti-reflux valvular system.

[0023] The anti-reflux gastroesophageal valvular prosthesis 1 comprises a body 2 having a seat 3 of a substantially semicircular shape.

[0024] Body 2 is of a substantially “half-moon” shape, defining a kind of collar that can be positioned inside the abdomen, in the zone of passage between esophagus and stomach, that is, in the gastroesophageal joint around the esophagus.

[0025] In particular, the prosthesis in inserted into the abdomen with a microinvasive laparoscopic technique.

[0026] The prosthesis further comprises means for engagement with the gastric wall of the stomach in the form of small tubes 5 which are connected to the body 2.

[0027] The prosthesis further comprises means of inflation capable of inflating at least body 2 to allow its volume to vary so as to accentuate the angle of His, that is, to accentuate the angulation between the esophagus and the stomach supported by the diaphragmatic cruses and simultaneously to improve the natural anti-reflux valvular system.

[0028] More precisely, the tubes 5 end in at least two distal inflatable elements, 6.

[0029] Small tubes 5 fluid-dynamically connect inflatable distal elements 6 to body 2 and are made of material that is elastically pliable axially, so as to vary their length elastically.

[0030] The means for inflation 7 can comprise a container 8 of a fluid for simultaneous inflation of both body 2 and distal elements 6.

[0031] Advantageously, inflatable elements 6 are anchored in the distal antrum, substantially side by side, (FIG. 7) and at a distance from body 2 substantially equal to the length of the small tubes 5.

[0032] Thus, as body 2 and, consequently, distal elements 6 inflate, there is, also thanks to the axial elasticity of small tubes 5, a restriction of the gastroesophageal tract and an improvement of continence with the simultaneous impediment of reflux.

[0033] In other words, the inflation of body 2 pulls the stomach partially herniated into the thorax downward, that is, toward the abdomen.

[0034] Thus the angle of His is accentuated and the natural anti-reflux valvular system is improved.

[0035] Furthermore, when the stomach distends due to the effect of the food accumulated inside it during the gastric phase of digestion, this angling is accentuated as the download stretching of the entire esophageal-gastric joint.

[0036] The body 2 and also the small tubes 5 and distal elements 6, may present a reinforcement core capable of resisting tractive forces to allow their removal without a new surgical intervention.

[0037] Moreover, the prosthesis described above may be easily coupled to the positioning of a gastric pacemaker and may be useful to stimulate the gastric portion of the sphincteral smooth musculature (inferior esophageal sphincter) perhaps during the patient's reflux timing.

[0038] Moreover, advantageously, body 2 present a median zone 10 of greater breadth suitable in shape and size for exerting pressure on the stomach only in the functional sense, mainly when the stomach is full of food, so that the distal elements and body 2 are automatically activated according to the natural functions during the patient's digestive phase.

[0039] Thus problems of decubitus are avoided, since the prosthesis always remains mobile, constricting the esophagus and lowering the stomach only in the functional sense and only when it is useful, that is, when the stomach is full of food that should not reascend into the esophagus.

[0040] The functioning of the prosthesis according to the invention appears evident from what has just been described and illustrated.

[0041] In practice it has been confirmed that the prosthesis of the invention is particularly advantageous for compensating remarkably both for the defects and inadequacies of medical reflux therapy based on pro-kinetic and antacid agents, and for the problems and drawbacks determined by surgical intervention that, in most cases, lead to anatomical changes with consequent complications and disturbances that the patient cannot tolerate.

[0042] Substantially, after suitable inflation, the prosthesis adjusts automatically and present an automatic reaction to the difficulties caused by esophagitis, in that the more the stomach dilates proximally due to the presence of food and the more the angulation is accentuated, the more the cardiac esophagus, that is, passageway between the esophagus and stomach closes.

[0043] The invention thus conceived is susceptible to numerous modifications and variations, all falling within the scope of the inventive concept, and furthermore, all details can be substituted by technically equivalent elements.

[0044] In practice any materials and dimensions may be used, depending on the demands and on the state of the art.