IT201900008550A1 - PROSTHESES FOR ENTEROSTOMIZED - Google Patents

Description

Description of Patent for Industrial Invention entitled:

"PROSTHESES FOR ENTEROSTOMIZED".

DESCRIPTION

The present invention refers to a prosthesis for enterostomies.

In medical practice, following serious intestinal pathologies or as a completion of surgical interventions, it may be necessary to amputate the terminal part of the bowel, which must thus be connected with the outside in order to be able to download its contents.

For this purpose it is practice to practice an enterostomy, that is a practice aimed at constituting a "stoma", that is a preternatural opening made in the abdominal wall and aimed at connecting any point of the intestine with the outside, in such a way as to allow the discharge of intestinal contents, that is, of feces and gases. Following the amputation of the terminal tract of the bowel, the voluntary control of continence is lacking, making it necessary to discharge the intestinal contents outside.

To solve these problems, bags that can be applied directly to the stoma and suitable for the collection of feces freely discharged outside are currently in use among enterostomized patients.

However, these bags have various drawbacks which hinder the patient's normal social reintegration, considerably affecting the patient's quality of life.

In fact, in addition to creating aesthetic problems, the use of these bags, not providing for the restoration of the voluntary control of the evacuation, involves complex and frequent maintenance, to be repeated at short intervals of time and even several times within a day. , forcing the patient to be close to places of decency.

Furthermore, the use of these bags is not free from possible complications related to the presence of adhesives that allow them to adhere to the patient's skin.

Added to this is the fact that these bags require frequent replacement, resulting in a high waste of time in changing used bags and difficulties in disposing of the same by the patient.

Furthermore, it is easy to understand how the need for frequent and short-term replacements leads to substantial costs for replacing the used bags.

However, to obviate at least in part the aforementioned drawbacks, occluding artificial prostheses have been developed. This type of prosthesis is useful for ensuring the voluntary control of continence through the reversible occlusion of the stoma.

In detail, this occlusion must be partial in such a way as to prevent the escape of faeces and, at the same time, allow the escape of gas. The use of the aforementioned artificial prostheses, which does not exclude the alternation with the containment bags, is undertaken during the terminal stage of the stoma healing which up to that moment involves the use of known bags.

A first type of the aforementioned artificial prostheses consists of two or more parts separated and interacting with each other by simple electromagnetic attraction.

In detail, these artificial prostheses comprise a support element with a substantially annular and magnetized conformation, which is surgically implanted in the subcutaneous tissue of the patient's abdomen, in correspondence with the loop affected by the stoma, and a closure element provided with a perimeter band metal which provides for the occlusion of the stoma by associating itself to the annular element by electromagnetic attraction.

However, the implantation of the aforementioned artificial prostheses requires a complex surgery with numerous possible complications including infections of the peristomal tissues, to which is added the need for periodic irrigation aimed at maintaining bowel cleanliness over time. A second type of artificial prosthesis, based on the same principle of electromagnetic attraction between the constituent parts of the prosthesis itself, involves gluing an interchangeable ring to the skin surrounding the stoma on which a magnetized closure element is made to adhere.

However, even this second type of artificial prosthesis has some drawbacks linked to the presence of adhesive substances, which, following prolonged contact with the skin, often cause irritation. Added to this is the need to provide for frequent bowel irrigation, so that the latter remains empty; it is easy to understand how the aforementioned types of prostheses are not very attractive for patients, considerably increasing the discomfort associated with a clinical condition which is already complex in itself.

In addition to these types of prostheses, there are others that involve gluing the ring to the skin and joining the closure element by interlocking; however, even in this case repeated and frequent bowel irrigations are necessary, increasing the discomfort of patients involved in such contingencies.

Due to the aforementioned inconveniences and inconveniences caused to patients, these prostheses are nowadays very little widespread.

Faced with these problems, starting from about 1980, artificial prostheses were developed consisting of a single monolithic body and made of rigid and non-deformable material. These prostheses comprise a tubular element that can be inserted inside the stoma and associated at one end with external holding means adapted to cooperate with the patient's body.

In detail, these holding means are made in the form of a flange element designed to abut the patient's skin.

The tubular element is provided with locking means including a balloon which, by inflating, allows the locking of the tubular element inside the stoma and, deflating, allows its insertion and extraction.

However, these prostheses being made of rigid material are rather annoying during the flexion movements of the trunk, or for example in the face of a prolonged time in a sitting position.

To at least partially obviate the aforementioned drawbacks, prostheses have been developed comprising a tubular element provided with a deformable body at the end inserted inside the stoma, i.e. opposite to the external holding means.

To date, another type of prosthesis has entered production comprising a tubular element associated for one end with a flange element designed to cooperate with a patient's body. The tubular element also has an expandable locking element capable of retaining the tubular element itself inside the stoma and substantially shaped like a catheter; in other words, the tubular element has thin walls and a large internal lumen that is used for irrigation to empty the intestinal contents while the tubular element itself is positioned in place, connected to a collection bag. The realization of this type of prosthesis was foreseen both in rigid and soft material.

The solution made of soft material is used in severe cases of bedridden patients, the use has been tested by keeping the prosthesis in place inside the stoma for long periods in order to facilitate maintenance of the stoma by the staff, and also to avoid and possibly treat serious lesions of the peristomal or perianal tissues in patients who are not self-sufficient or in a coma.

This type of prosthesis has not found widespread diffusion, and a more advanced model has been created, similar to a catheter aimed at diversion of the intestinal contents away from the skin surface intended to avoid contact with the intestinal contents in the course of serious pathologies such as burns, ulcerations , infections in the area around the stoma.

These prosthetic models are also used in non self-sufficient and bedridden patients to facilitate ostomy care by the staff in charge. To overcome these drawbacks, another type of prosthesis has been developed equipped with a cylinder made of hydrophilic dehydrated material and surrounded by a water-soluble and impermeable film that dissolves in contact with intestinal fluids, causing the balloon to inflate which assumes a substantially truncated cone conformation.

This conformation does not ensure the sealing and locking of the prosthesis inside the stoma, so the adhesion of the external flange to the skin must be ensured by means of an adhesive very similar to that of the collection bags, in order to avoid the leakage of the prosthesis itself.

A last type of known prosthesis consists of a single monolithic body provided with a hollow tubular element made of rigid material having a first end associated with a flange element and a second end associated with a balloon which, once filled with a fluid, it dilates beyond the abdominal wall, blocking the prosthesis itself inside the stoma.

The continence of stool and gas is obtained by inflating the balloon, while the escape of the stool is carried out, without deflating the balloon at the end of the device, by means of the total deflation of the balloon inside the hollow stem; in detail, the collection of feces takes place by associating a containment bag with the flange element, or by irrigation by means of a special integrated system.

At the same time, the gases are released by means of the partial deflation of the balloon inside the stem.

This type of prosthesis is also described in patent documents DE2431888, US6485476, US2011 / 306823 and US2013 / 197458.

This prosthesis can be anchored inside the stoma for a time not exceeding 28 days, after which the prosthesis must be replaced. It is easy to understand how the use of this known type prosthesis is complex and cumbersome, to which is added the fact that it requires a complex kit of integrated parts.

Description of the Invention

The main task of the present invention is to devise a prosthesis for enterostomies that can be adapted to the positions assumed by the patient without causing discomfort and discomfort, allowing maximum freedom of movement, increasing comfort and ease of use compared to known devices.

Another object of the present invention is to devise a prosthesis for enterostomies which considerably increases the quality of life of enterostomized patients.

Another object of the present invention is to devise a prosthesis for enterostomies which allows to control the emission of the intestinal contents allowing patients to use commonly used places of decency, including the toilets of means of transport without the need to dispose of with own means the collection bags filled with intestinal contents.

A further object of the present invention is to devise a prosthesis for enterostomies that eliminates the discomforts related to the need to perform periodic procedures for cleaning the intestinal contents by means of the complex and expensive practice of irrigation.

Another object of the present invention is to devise a prosthesis that allows to overcome the aforementioned drawbacks of the prior art within the context of a simple, rational, easy and effective use and low cost solution.

The above objects are achieved by the present prosthesis for enterostomies having the characteristics of claim 1.

Other characteristics and advantages of the present invention will become more evident from the description of a preferred but not exclusive embodiment of a prosthesis for enterostomies, illustrated by way of indication, but not of limitation, in the accompanying drawings in which: Figure 1 is a front view of the prosthesis according to the invention;

Figure 2 is a sectional view of the prosthesis of Figure 1;

Figure 3 is a schematic representation of the prosthesis of Figure 3 in a first operating mode;

Figure 4 is a schematic representation of the prosthesis of Figure 3 in a second operating mode.

With particular reference to these figures, 1 generally indicates a prosthesis for enterostomies.

The prosthesis 1 comprises a tubular element 2 with an elongated conformation and which can be inserted substantially to size inside a stoma 3 made on the abdominal wall 4 of a patient.

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 that can be inserted inside the stoma 3, and a second end 7 aimed at remaining outside the stoma itself. .

The tubular element 2 has a diameter substantially matching the diameter of the stoma 3 in such a way as to be inserted to measure or with slight interference inside it, and a length greater than the thickness of the abdominal wall 4 so that once inserted it remains inside the same. inside the stoma 3 and is accessible from the outside.

In detail, the tubular element 2 has a circular section. However, alternative construction solutions are not excluded in which the tubular element 2 has a square or polygonal section.

The prosthesis 1 comprises first obstruction means 8 for obstructing at least one area of the stoma 3.

The first obstruction means 8 are associated with the first end 6 of the tubular element 2 and can be moved between a narrow configuration 9 (in figure 3) and an enlarged configuration (in figure 4), respectively to allow their insertion and / or the extraction of the tubular element in / from the stoma 3 and to prevent the escape of faeces from the stoma itself.

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

The retaining element 11 is of the type of a flange element abutting the abdominal wall 4.

Advantageously, the holding element 11 is coaxial with the tubular element 2.

At least one of the tubular element 2 and the retaining element 11 is made at least in part in flexible material.

Preferably, at least one of the tubular element 2 and the retaining element 11 is made of flexible polymeric material such as rubber or the like.

It is useful to point out that in the context of this discussion the expression "flexible material" means a material capable of elastically deforming as a result of external stresses, such as bending of the abdomen or particular positions assumed by the patient. With reference to a preferred embodiment solution, the tubular element 2 and the flange element 11 are made of flexible material.

Preferably, the tubular element 2 and the flange element 11 are made with silicone-based polymer blends.

Advantageously, the tubular element 2 and the flange element 11 are made in a single monolithic piece.

Specifically, the tubular element 2 and the flange element 11, in practice, are made integral in a single body through, for example, a manufacturing process for injection molding.

With reference to the particular embodiment represented in the figures, the prosthesis 1 comprises a yielding element 12 arranged along the tubular element 2 near the flange element 11.

In this case, the yielding element 12 is interposed between the portion of the abdominal wall 4 of the patient and the flange element 11.

The prosthesis 1 comprises a first through duct 13 made on the tubular element 2 and communicating with the first obstruction means 8. The tubular element 2 is provided with valve means 14 which can be connected to means 15 for the forced introduction / extraction of a fluid in / from the first means of obstruction 8.

In detail, the valve means 14 comprise at least one bidirectional valve designed to ensure the maintenance of air pressure inside the first obstruction means 8.

The first duct 13 comprises a first hole 18 for communication with the first obstruction means 8.

The first communication hole 18 is adapted to allow the entry and / or extraction of the air from the first obstruction means 8, causing the passage from the restricted configuration 9 to the enlarged configuration 10. The first duct 13 can be connected to the means of introduction / extraction 15 by means of a first hole 16 made on the retaining element 11, that is, on the flange.

In detail, the bidirectional valve 14 is located near the first hole 16.

The introduction / extraction means 15 can be of the type of a disposable syringe, having a spout 17 that can be inserted inside the first hole 16 for the entry of fluid into the first duct 13.

In this regard, it should be emphasized that the term "fluid" means any substance or mixture of substances that deforms indefinitely when subjected to a shear stress and, regardless of the extent of the latter, with reference to a state of the matter that includes both gaseous and liquid substances.

Specifically, in a preferred embodiment, the fluid used for the passage between the restricted configuration 9 (in Figure 3), and the enlarged configuration 10 (in Figure 4), is air.

The prosthesis 1 comprises a second duct 19 made on the tubular element 2, communicating with the interior of the stoma 3 and provided with filtering means 20 for the escape of gas from the stoma itself.

As can be seen in the figures, the second duct 19 extends longitudinally from the second end 7 to the first end 6.

The second duct 19 is provided with a second hole 21 made on the retaining element 11, ie on the flange element, and with an evacuation hole 22 made on the first end 6.

Advantageously, the retaining element 11, ie the flange element, is provided with the two through holes 16, 21 arranged in correspondence with the first duct 13 and the second duct 19.

Preferably, the filter media 20 are of the type of an activated carbon filter inserted inside a non-toxic rubber cartridge.

According to the invention, the prosthesis 1 comprises second obstruction means 23 and third obstruction means 26 arranged along the tubular element 2 and movable between a relative narrow configuration 9 (in figure 3), and a relative enlarged configuration 10 (in figure 4) ), respectively to allow its insertion and / or extraction in / from the stoma 3 and to prevent the escape of faeces from the latter.

In detail, the second obstruction means 23 are adapted to vary the diameter of the tubular element 2 as a function of the diameter of the stoma 3, ensuring the obstruction of the stoma is substantially sealed.

At the same time, the third obstruction means 26 are designed to meet the abdominal wall internally, sealing the stoma 3.

Preferably, the third obstruction means 26 are arranged in proximity to the flange element 11.

Specifically, the third obstruction means 26 are arranged in proximity to the yielding element 12.

In other words, the third obstruction means 26, with reference to a configuration of normal use, are arranged below the yielding element 12.

Furthermore, preferably, the second obstruction means 23 are interposed between the first obstruction means 8 and the third obstruction means 26.

Preferably, the first obstruction means 8, the second obstruction means 23 and the third obstruction means 26 are coaxial to each other.

Advantageously, the first obstruction means 8, the second obstruction means 23 and the third obstruction means 26 comprise an inflatable balloon element.

In the particular embodiment shown in the figures, both the first obstruction means 8 and the second obstruction means 23 and the third obstruction means 26 consist of an inflatable balloon element. These inflatable balloon elements 8, 23, 26 are arranged externally to the tubular element 2 and are substantially deflated in the restricted configuration 9 (in figure 3), and inflated in the enlarged configuration 10 (in figure 4).

Advantageously, in the enlarged configuration, the first obstruction means 8 have a larger diameter than the second obstruction means 23.

Preferably, in the enlarged configuration, the third obstruction means 26 have a larger diameter than the second obstruction means 23.

Conveniently, the third obstruction means 26 have a larger diameter than the first obstruction means 8.

Preferably, the first obstruction means 8, the second obstruction means 23 and the third obstruction means 26 can be moved from the enlarged configuration 10 to the restricted configuration 9 simultaneously with each other.

For this purpose, as shown in Figures 1 and 2, the first duct 13 comprises a second hole 24 for communicating with the second obstruction means 23 for the introduction and / or extraction of the fluid into / from the second obstruction means. themselves.

Similarly, the first duct 13 also comprises a third hole for communication with the third obstruction means 26.

However, it is not excluded from the scope of the present discussion that the first obstruction means 8, the second obstruction means 23 and the third obstruction means 26 can be moved from the enlarged configuration 10 to the restricted configuration 9 and vice versa independently from each other.

In this regard, in an alternative embodiment, not shown in the figures, the second obstruction means 23 are also in communication with a third through duct made on the tubular element 2 and associable with the means 15 for introducing / extracting the fluid in / gives the second means of obstruction themselves.

In detail, the flange element 11 comprises a third through hole arranged in correspondence with the third through duct and used for the passage of fluid.

In an alternative embodiment, not shown in the figures, the third obstruction means 26 are in communication with a fourth through duct made on the tubular element 2 and associable with the means 15 for introducing / extracting the fluid into / from the fourth means of obstruction themselves.

This means that, in the aforementioned embodiment, i.e. in the case in which the first duct 13, the second duct 19 and the fourth duct are present, the prosthesis 1 is configured to allow the inflation and / or deflation of the first means respectively. obstruction 8, of the second obstruction means 23 and of the third obstruction means 26 independently of each other.

Similarly to the second duct 19, the third and fourth through ducts can also be provided with valve means 14, of the type of a bidirectional valve, designed to ensure the maintenance of air pressure inside the second obstruction means 23.

Again, similarly to the first duct 13, also the second duct 19 can be connected to the introduction / extraction means 15 by means of the third through hole.

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

Advantageously, the stiffening means 25 are helically wound and extend at least in part inside the ducts 13, 19.

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

Specifically, in the alternative embodiment described above, the stiffening means 25 are present in at least one of the third duct and the fourth duct.

In other words, it is not excluded from the scope of this discussion that both the third duct and the fourth duct are provided with stiffening means 25.

In detail, the stiffening means 25 are made of elastomeric material with a predefined hardness. Preferably, said stiffening means 25 are made of metallic material.

The presence of the stiffening means 25 is aimed at avoiding the crushing of the ducts 13, 19 following movements of the tubular element 2.

For example, in the case of particular positions assumed 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 thanks to its peculiar properties of flexibility and adaptability. Faced with these contingencies, the action of the stiffening means 25 allows the section of the ducts 13, 19 to be kept unchanged even following the aforementioned twisting and / or bending, without affecting the flexibility and overall adaptability of the tubular element 2 The operation of the present invention is as follows.

An enterostomized patient inserts the prosthesis 1 inside the stoma 3.

The first obstruction means 8, the second obstruction means 23 and the third obstruction means 26 are in a restricted configuration 9 (in Figure 3), ie they have their respective deflated balloon elements.

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

Once the prosthesis 1 has been positioned, the patient inflates the balloon elements 8, 23, 26 by positioning the spout 17 of the disposable syringe 15 inside the first hole 16.

More particularly, the balloon elements 8, 23, 26 are brought into their respective enlarged configurations 10 (in figure 4) by blowing air through the first duct 13. In this way the balloon elements 8, 23, 26 swell and, expanding, they occupy the entire section of the stoma 3.

As described above, the inflation and / or deflation of the balloon elements 8, 23, 26 can be simultaneous or independent of each other depending on whether they are provided, respectively, with only the first inflation / deflation duct 13 for all the balloon elements 8 , 23, 26 or of three distinct ducts, i.e. of the first duct 13, of the third duct and of the fourth inflation / deflation duct.

Furthermore, it is not excluded from the present discussion that the inflation and / or deflation of the balloon elements 8, 23, 26 is simultaneous for the first balloon element 8, for the second balloon element 23 and, in parallel, the inflation and / or the deflation of the third balloon element 26 is independent of the latter.

In other words, it is not excluded from the scope of this discussion that, for example, that:

- the first balloon element 8 and the third balloon element 23 are inflatable and / or deflatable simultaneously with each other, while the second balloon element 23 is inflatable and / or deflatable independently of the latter; or

- the second balloon element 23 is inflatable and / or deflatable simultaneously with the third balloon element 26, while the first balloon element 8 is inflatable and / or deflatable independently of the latter.

The balloon elements 8, 23, 26 are deformable and when they are in the enlarged configurations they therefore conform to the internal walls of the stoma 3.

In fact, the first obstruction means 8 provide for the locking of the prosthesis 1 inside the stoma 3, and the second obstruction means 23 allow the diameter of the tubular element 2 to be varied according to the specific size of the stoma 3, ie substantially sealing it.

Faced with the need to empty the intestinal contents externally, the patient deflates the obstruction means 8, 23, 26 by inserting the spout 17 inside the first hole 16 and extracting the air from the obstruction means themselves.

The obstruction means 8, 23, 26 are in a restricted configuration 9 (in figure 3), and, therefore, the prosthesis 1 is extracted from the stoma 3 to allow the intestinal contents to be discharged outside.

In practice it has been found that the described invention achieves the proposed purposes.

In particular, it is emphasized that the particular expedient of providing for the presence of flexible materials allows the creation of a prosthesis that can be adapted to any position assumed by the patient.

In addition, the fact of using elastomeric materials allows the obtaining of a prosthesis whose shape is adaptable to the needs of patients and is made using construction techniques such as injection molding which allow a significant reduction in the production costs of the prosthesis.

Claims (13)

CLAIMS 1) Prosthesis (1) for enterostomies, comprising: - at least one tubular element (2) of elongated conformation and substantially insertable to size inside a stoma (3) made on the abdominal wall (4) of a patient; - at least first obstruction means (8) for obstructing at least one area of the stoma (3), associated with a first end (6) of said tubular element (2) and movable between a narrow configuration (9) and an enlarged configuration (10 ), respectively to allow its insertion / extraction in / from said stoma (3) and to prevent the leakage of faeces from the stoma itself; - at least a first passing duct (13) made on said tubular element (2), communicating with said first obstruction means (8) and provided with valve means (14) connectable to forced introduction / extraction means (15) of a fluid in / from said first obstruction means (8); - at least a second passing duct (19) made on said tubular element (2), communicating with the inside of the stoma (3) and equipped with filtering means (20) for the escape of gas from the stoma itself; And - at least one external retaining element (11) associated with a second end (7) of said tubular element (2) opposite said first end (6) and able to cooperate with at least a portion of the abdominal wall (4) and provided with at least two through holes (16, 21) arranged in correspondence with said first conduit (13) and said second conduit (19); characterized in that it comprises second obstruction means (23) and third obstruction means (26) arranged along said tubular element (2) and movable between a relative narrow configuration (9) and a relative enlarged configuration (10), respectively to allow insertion and removal into / from said stoma (3) and to prevent the escape of faeces from the latter. 2) Prosthesis (1) according to claim 1, characterized in that at least one of said first obstruction means (8), said second obstruction means (23) and said third obstruction means (26) comprise at least one balloon element inflatable designed to lock said prosthesis inside said stoma (3). 3) Prosthesis (1) according to one or more of the preceding claims, characterized in that said first obstruction means (8), said second obstruction means (23) and said third obstruction means (26) can be moved by said enlarged configuration (10) to said restricted configuration (9) and vice versa independently from each other. 4) Prosthesis (1) according to one or more of the preceding claims, characterized in that said first obstruction means (8), said second obstruction means (23) and said third obstruction means (8) can be moved by said enlarged configuration (10) to said restricted configuration (9) simultaneously with each other. 5) Prosthesis (1) according to one or more of the preceding claims, characterized in that, in said enlarged configuration, said first obstruction means (8) have a larger diameter than said second obstruction means (23). 6) Prosthesis (1) according to one or more of the preceding claims, characterized in that, in said enlarged configuration, said third obstruction means (26) have a diameter greater than said second obstruction means (23). 7) Prosthesis (1) according to one or more of the preceding claims, characterized in that, in said enlarged configuration, said third obstruction means (26) have a diameter greater than said first obstruction means (8). 8) Prosthesis (1) according to one or more of the preceding claims, characterized in that said first duct (13) comprises a first communication hole (18) with said first obstruction means (8), and a second communication hole ( 24) with said second obstruction means (23) for the introduction and / or extraction of said fluid respectively into / from said first obstruction means (8) and said second obstruction means themselves. 9) Prosthesis (1) according to one or more of the preceding claims, characterized in that said first duct (13) comprises a third hole for communication (27) with said third obstruction means (26). 10) Prosthesis (1) according to one or more of the preceding claims, characterized in that it comprises at least a third through duct made on said tubular element (2), communicating with said second obstruction means (23) and / or with said third means obstruction (26) and connectable to said forced introduction / extraction means (15) of said fluid into / from said second obstruction means. 11) Prosthesis (1) according to one or more of the preceding claims, characterized in that it comprises at least a fourth through duct made on said tubular element (2) and connectable to said forced introduction / extraction means (15) of said fluid into / by said third obstruction means themselves. 12) Prosthesis (1) according to one or more of the preceding claims, characterized in that said third obstruction means (26), in said enlarged configuration, have a diameter substantially equal to said retaining element (11). 13) Prosthesis (1) according to one or more of the preceding claims, characterized in that said third obstruction means (26) are designed to meet internally said abdominal wall, sealing said stoma (3).