Prosthesis For Enterostomy Patients

Abstract

The prosthesis (1) for enterostomy patients comprises: a tubular element (2) of elongated shape and insertable substantially to size inside of a stoma (3) made on the abdominal wall (4) of a patient; a first obstruction means (8) to obstruct at least one area of the stoma (3), associated with a first end (6) of the tubular element (2) and movable between a restricted configuration (9) and an enlarged configuration (10) to allow the insertion/extraction into/from the stoma (3) respectively, and to prevent leakage of feces from the stoma itself; a first through duct (13) made on the tubular element (2), communicating with the first obstruction means (8) and having valve means (14) connectable to forced introduction/extraction means (15) of a fluid into/from the first obstruction means (8); a second through duct (19) made on the tubular element (2), communicating with the inside of the stoma (3) and having filtering means (20) for the outflow of gases from the stoma itself; and an external retaining element (11) associated with a second end (7) of the tubular element (2) opposite to the first end (6) and able to cooperate with at least one portion of the abdominal wall (4) and having at least two through holes (16, 21) arranged at the first duct (13) and the second duct (19); in which at least one of the tubular element (2) and the retaining element (11) is made at least partially of a flexible material.

Claims

1. Prosthesis for enterostomy patients, comprising: at least a tubular element of elongated shape and insertable substantially to size inside of a stoma made on the abdominal wall of a patient; at least first obstruction means to obstruct at least one area of the stoma, associated with a first end of said tubular element and movable between a restricted configuration and an enlarged configuration to allow the insertion/extraction into/from said stoma respectively, and to prevent leakage of feces from the stoma itself; at least a first through duct made on said tubular element, communicating with said first obstruction means and having valve means connectable to forced introduction/extraction means of a fluid into/from said first obstruction means; at least a second through duct made on said tubular element, communicating with the inside of the stoma and having filtering means for the outflow of gases from the stoma itself; and at least an external retaining element associated with a second end of said tubular element opposite to said first end and able to cooperate with at least one portion of the abdominal wall and having at least two through holes arranged at said first duct and said second duct; wherein at least one of said tubular element and said retaining element is made at least partially of a flexible material.

2. Prosthesis according to claim 1, wherein in that it comprises second obstruction means arranged along said tubular element and movable between a respective restricted configuration and a respective enlarged configuration to allow the insertion/extraction into/from said stoma respectively, and to prevent feces from coming out of the stoma itself.

3. Prosthesis according to claim 1, wherein said first through duct comprises a first communication hole with said first obstruction means, and a second communication hole with said second obstruction means for the introduction/extraction of said fluid into/from said first obstruction means and said second obstruction means themselves, respectively.

4. Prosthesis according to claim 2, wherein it comprises at least a third through duct made on said tubular element, communicating with said second obstruction means and connectable to said forced introduction/extraction means of said fluid into/from said second obstruction means themselves.

5. Prosthesis according to claim 2, wherein said first obstruction means and/or said second obstruction means are of the type of an inflatable balloon.

6. Prosthesis according to claim 1, wherein said retaining element is of the type of a flange element in abutment against said portion of the abdominal wall.

7. Prosthesis according to claim 6, wherein it comprises at least one yielding element arranged along said tubular element in the proximity of said flange element, said yielding element interposing between said portion of the abdominal wall and said flange element itself.

8. Prosthesis according to claim 6, wherein said tubular element and said flange element are made of a flexible material.

9. Prosthesis according to claim 6, wherein said tubular element and said flange element are made in a single monolithic body.

10. Prosthesis according to claim 1, wherein it comprises stiffening means associated with at least one of said ducts.

11. Prosthesis according to claim 10, wherein said stiffening means are wound in a helix and extend at least partially inside of said through ducts.

12. Prosthesis according to claim 10, wherein said stiffening means are made of an elastomeric material of predefined hardness.

13. Prosthesis according to claim 10, wherein said stiffening means are made of a metallic material.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Other characteristics and advantages of the present invention will become better evident from the description of a preferred, but not exclusive, embodiment of a prosthesis for enterostomy patients, illustrated by way of an indicative, but non-limiting, example in the accompanying drawings, wherein:

[0043] FIG. 1 is a front view of the prosthesis according to the invention in a first embodiment;

[0044] FIG. 2 is a sectional view of the prosthesis of FIG. 1;

[0045] FIG. 3 is a front view of the prosthesis according to the invention in a second embodiment;

[0046] FIG. 4 is a sectional view of the prosthesis of FIG. 3;

[0047] FIG. 5 is a schematic representation of the prosthesis of FIG. 3 in a first operating mode;

[0048] FIG. 6 is a schematic representation of the prosthesis of FIG. 3 in a second operating mode.

EMBODIMENTS OF THE INVENTION

[0049] With particular reference to such figures, globally indicated with reference number 1 is a prosthesis for enterostomy patients.

[0050] The prosthesis 1 comprises a tubular element 2 of elongated shape and insertable substantially to size inside of a stoma 3 made on the abdominal wall 4 of a patient.

[0051] With reference to the particular embodiment shown in the figures, the tubular element 2 is coaxial to a longitudinal axis 5 and has a first end 6 insertable inside of the stoma 3, and a second end 7 intended to stay outside of the stoma itself.

[0052] The tubular element 2 has a diameter substantially mating to the diameter of the stoma 3 so as to be inserted to size or with a slight play inside of the same, and a greater length than the thickness of the abdominal wall 4 so that once inserted it remains inside of the stoma 3.

[0053] In detail, the tubular element 2 has a circular section. Alternative embodiments cannot however be ruled out in which the tubular element 2 has a square or polygonal cross section.

[0054] In a first embodiment shown in FIGS. 1 and 2, the prosthesis 1 comprises first obstruction means 8 to obstruct at least one area of the stoma 3.

[0055] The first obstruction means 8 are associated with the first end 6 of the tubular element 2 and are movable between a restricted configuration 9 (in FIG. 5), and an enlarged configuration (in FIG. 6), to allow the insertion/extraction respectively of the tubular element into/from the stoma 3 and to prevent leakage of feces from the stoma itself.

[0056] The prosthesis 1 comprises an external retaining element 11 associated with the second end 7 of the tubular element 2 opposite to the first end 6 and adapted to cooperate with a portion of the abdominal wall 4 of the patient.

[0057] The retaining element 11 is of the type of a flange element abutting against the abdominal wall 4.

[0058] Advantageously, the retaining element 11 is coaxial to the tubular element 2. According to the invention, at least one of the tubular element 2 and the retaining element 11 is made at least partially of a flexible material.

[0059] Preferably, at least one of the tubular element 2 and the retaining element 11 is made of a flexible polymeric material of the type of rubber or the like.

[0060] It is useful to point out that in the present discussion by the term flexible material is meant a material able to deform elastically as a result of external stresses, such as e.g. abdomen flexions or particular positions taken by the patient.

[0061] With reference to a preferred embodiment, the tubular element 2 and the flange element 11 are made of a flexible material.

[0062] Preferably, the tubular element 2 and the flange element 11 are made of silicone-based polymeric mixtures.

[0063] Advantageously, the tubular element 2 and the flange element 11 are made in a single monolithic body.

[0064] Specifically, the tubular element 2 and the flange element 11, in practice, are made integral in a single body by means of, e.g., a manufacturing process by injection molding.

[0065] With reference to the particular embodiment shown in the figures, the prosthesis 1 comprises a yielding element 12 arranged along the tubular element 2 in the proximity of the flange element 11.

[0066] In the present case, the yielding element 12 is between the portion of the abdominal wall 4 of the patient and the flange element 11.

[0067] The prosthesis 1 comprises a first through duct 13 made on the tubular element 2 communicating with the first obstruction means 8.

[0068] The tubular element 2 has valve means 14 connectable to forced introduction/extraction means 15 of a fluid into/from the first obstruction means 8.

[0069] Furthermore, the valve means 14 comprise at least one two-way valve adapted to ensure the maintenance of pressurized air inside of the first obstruction means 8.

[0070] The first through duct 13 comprises a first communication hole 18 with the first obstruction means 8.

[0071] The first communication hole 18 is adapted to allow the entry/extraction of air from the first obstruction means 8, causing the passage from the restricted configuration 9 to the enlarged configuration 10.

[0072] The first duct 13 is connectable to the introduction/extraction means 15 by means of a first hole 16 made on the retaining element 11, i.e. on the flange.

[0073] The introduction/extraction means 15 may be of the type of a disposable syringe, having a spout 17 insertable inside of the first hole 16 for the introduction of the fluid inside of the first through duct 13.

[0074] In this regard it should be noticed that by the term fluid is meant any substance or mixture of substances which deforms indefinitely when subjected to a shear stress and, irrespective of the amount of the latter, with reference to a state of matter including substances in either gaseous or liquid state.

[0075] Specifically, in a preferred embodiment, the fluid used for the passage between the restricted configuration 9 (in FIG. 5) and the enlarged configuration 10 (in FIG. 6), is air.

[0076] The prosthesis 1 comprises a second duct 19 made on the tubular element 2, communicating with the inside of the stoma 3 and having filtering means 20 for the outflow of gases from the stoma itself.

[0077] As is visible in the figures, the second duct 19 extends longitudinally from the second end 7 to the first end 6.

[0078] The second duct 19 has a second hole 21 made on the retaining element 11, i.e. on the flange element, and an evacuation hole 22 made on the first end 6. Advantageously, the retaining element 11, that is the flange element, has the two through holes 16, 21 arranged at the first duct 13 and the second duct 19. Preferably, the filtering means 20 are of the type of an active carbon filter placed inside of a non-toxic rubber cartridge.

[0079] The prosthesis 1 comprises second obstruction means 23 arranged along the tubular element 2 and movable between a respective restricted configuration 9 (in FIG. 5), and a respective enlarged configuration 10 (in FIG. 6), to allow the insertion/extraction into/from the stoma 3 respectively, and to prevent feces from coming out of the stoma itself.

[0080] In detail, the second obstruction means 23 are adapted to vary the diameter of the tubular element 2 based on the diameter of the stoma 3, thus ensuring the substantially sealing obstruction of the stoma itself.

[0081] Preferably, the second obstruction means 23 are arranged in the proximity of the flange element 11.

[0082] Specifically, the second obstruction means 23 are in the proximity of the yielding element 12.

[0083] Preferably, the first obstruction means 8 and the second obstruction means 23 are coaxial to one another.

[0084] Advantageously, the first obstruction means 8 and/or the second obstruction means 23 are of the type of an inflatable balloon.

[0085] In the particular embodiment shown in FIGS. 3, 4, 5 and 6, both the first obstruction means 8 and the second obstruction means 23 are of the type of an inflatable balloon.

[0086] These inflatable balloons 8, 23 are arranged externally to the tubular element 2 and are substantially deflated in the restricted configuration 9 (in FIG. 5), and inflated in the enlarged configuration 10 (in FIG. 6).

[0087] Furthermore, the first through duct 13 comprises a second communication hole 24 with the second obstruction means 23 for the introduction/extraction of the fluid into/from the second obstruction means themselves.

[0088] In an alternative embodiment, not shown in the figures, the second obstruction means 23 are in communication with a third through duct made on the tubular element 2 and associable with the introduction/extraction means 15 of the fluid into/from the second obstruction means themselves.

[0089] In detail, the flange element 11 comprises a third through hole arranged at the third through duct and used for the passage of the fluid.

[0090] Similarly to the second duct 19, also the third through duct may have valve means 14, the type of a two-way valve, adapted to ensure the maintenance of pressurized air inside of the second obstruction means 23.

[0091] The prosthesis 1 comprises stiffening means 25 associated with at least one of the ducts 13, 19.

[0092] Advantageously, the stiffening means 25 are wound in a helix and extend at least partially inside of the ducts 13, 19.

[0093] In a preferred embodiment, the stiffening means 25 extend internally to the ducts 13, 19.

[0094] In detail, the stiffening means 25 are made of an elastomeric material of predefined hardness. Preferably, the aforesaid stiffening means 25 are made of a metallic material.

[0095] The presence of the stiffening means 25 is intended to prevent crushing of the ducts 13, 19 as a result of the movements of the tubular element 2.

[0096] For example, in case of particular positions taken by the patient such as twisting and/or bending of the abdominal wall 4, the tubular element 2, in turn, is subject to twisting and/or bending due to its peculiar properties of flexibility and adaptability. In such a situation, the action of the stiffening means 25 allows to maintain unchanged the section of the ducts 13, 19 also as a result of the above twisting and/or bending, without affecting the flexibility and overall adaptability of the tubular element 2.

[0097] The operation of the present invention is as follows.

[0098] An enterostomy patient inserts the prosthesis 1 inside of the stoma 3.

[0099] The first obstruction means 8 and the second obstruction means 23 are in the restricted configuration 9 (in FIG. 5), that is, they have their respective balloons deflated.

[0100] The prosthesis 1 is positioned by placing the yielding element 12 in contact with the abdominal wall 4.

[0101] After positioning the prosthesis 1, the patient provides for the inflation of the balloons 8, 23 by positioning the spout 17 of the disposable syringe 15 inside of the first hole 16.

[0102] More particularly, the balloons 8, 23 are brought to their respective enlarged configurations 10 (in FIG. 6) by blowing air through the first duct 13. This way the balloons 8, 23 inflate and, by widening, they occupy the whole section of the stoma 3.

[0103] As described above, the inflation of the balloons 8, 23 can be simultaneous or independent to one another depending on the fact that they have only the first inflation/deflation duct 13 for both balloons 8, 23 or two separate inflation/deflation ducts, respectively, namely the tubular element 2 has a third duct.

[0104] The balloons 8, 23 are deformable and when they are in the enlarged configurations they conform therefore to the inner walls of the stoma 3.

[0105] In fact, the first obstruction means 8 ensure the locking of the prosthesis 1 inside of the stoma 3, and the second obstruction means 23 allow to vary the diameter of the tubular element 2 according to the specific size of the stoma 3, i.e. substantially sealing it.

[0106] Taking into consideration the need to empty the intestinal contents outside, the patient deflates the obstruction means 8, 23, by inserting the spout 17 inside of the first hole 16 and by extracting the air out of the obstruction means themselves.

[0107] The obstruction means 8, 23 are in the restricted configuration 9 (in FIG. 5), and, therefore, the prosthesis 1 is extracted from the stoma 3 to allow the discharge of intestinal contents to the outside.

[0108] It has in practice been found that the described invention achieves the intended objects.

[0109] In particular, it is underlined that the particular expedient to provide for the presence of flexible materials allows for the realization of a prosthesis adaptable to any position taken by the patient.

[0110] To this is added that the fact of using elastomeric materials allows obtaining a prosthesis the shape of which is adaptable to the needs of patients and is made through constructive techniques such as injection molding which allow for a considerable reduction of the production costs of the prosthesis.