Field of Application

The present invention is generally applicable to the technical field of the surgical devices, and particularly relates to a prosthetic device intended for use in colostomy operations.

The invention also relates to a feces collection container usable with the aforesaid device and a colostomy assembly comprising the prosthetic device and the collection container. State of the Art

As is known, the colostomy surgical technique allows deviating a portion of the intestinal tube outside the body of the patient, both in a definitive and temporary manner.

One frequently used technique, known as cutaneous colostomy, provides for the passage of a colonic loop through the thickness of the abdominal wall of the patent. The stable fixing of the colonic loop to the body of the patient occurs by suturing the externally-directed end of the loop itself with the skin of the abdomen.

Subsequently, a collection container can be removably connected to the end of the colonic loop in order to allow the collection and subsequent evacuation of the feces coming from the intestinal tube. One drawback of such solution is represented by the fact that such technique produces a high percentage of cases (about 60%) in which medical complications arise after colostomy, which make patient tolerability difficult. First of all, there is a high possibility that the skin of the abdomen placed close to the end of the colonic loop can come into contact with the fecal material expelled during the evacuation phase.

The contact with the feces can cause the onset of dermatitides, which require special care for their treatment; in the most serious cases, patients can be subjected to ongoing treatments lasting several months.

Further complications can be caused by the rise of serious diseases such as stenosis, retractions with cavity formation, prolapses and parastomal hernias.

In order to at least partly overcome these drawbacks, prosthetic devices for colostomy have been made which provide for the isolation of the patient's skin from the colonic loop. A device for colostomy is known from US4265244, illustrated in Fig. 1 , having an adaptor A of substantially tubular form with a first end portion P-i intended to come into contact with the skin D of the patient in order to be connected to a feces collection bag. The adaptor A also comprises a second end portion P ₂ that is substantially tubular and intended to be inserted inside the abdominal incision B.

The termination of the colonic loop C to be colostomized is made to slide outside the external surface S of the adaptor A in a manner such that the same comes into contact with the fecal material during evacuation. In order to protect the patient from possible irritation, the adaptor A is configured for fixing the colonic loop C to the abdominal skin D in a manner such that its external end surface S is interposed between the loop C itself and the skin D, preventing their contact during the evacuation of the fecal material.

One drawback of such solution is represented by the fact that also in such configuration, the colonic loop is in contact with the skin of the abdomen, even if in a partial manner; hence there is the risk of onset of the complications and/or diseases described above.

Another drawback of such solution is represented by the fact that the fixing and the removal of the collection device must be carried out with particular care in order to avoid affecting the seal of the adaptor and to avoid compromising the suture of the colonic loop with the abdominal skin.

In addition, the cleaning of the collection devices and of the external end of the adaptor must be frequently carried out, since there is a significant risk that a portion of the feces can penetrate between the adaptor and the colonic loop, and thus come into contact with the portion of the abdominal skin sutured to the loop itself.

Presentation of the Invention

The object of the present invention is to remedy the abovementioned drawbacks, by providing a prosthetic device for colostomy which is characterized by high efficiency and relatively reduced cost.

One particular object is to obtain a prosthetic device for colostomy which does not require the fixing to the abdominal skin of the patient, avoiding the risk of skin diseases such as dermatitis or the like. One particular object is to obtain a prosthetic device for colostomy that allows preventing the feces material from coming into contact with the abdominal skin during the intestinal expulsion step. A further object is to obtain a prosthetic device for colostomy which allows a high bacterial isolation between the device portion intended to be in contact with the feces and the device portion in contact with the abdominal wall, preventing the onset of medical complications or diseases such as dermatitis, stenosis, prolapses and parastomal hernias.

Yet another object is to obtain a feces collection container that can be easily coupled to the prosthetic device.

Not the least object is to provide a prosthetic assembly for colostomies which is easy to apply to the body of a patient and which allows the simple and quick removal of the collected feces.

Such objects, as well as others which will appear more clearly below, are achieved by a prosthetic device for colostomy, in accordance with claim 1 , comprising a tubular connector suitable for being connected to a feces collection container, said connector having an annular end edge intended to be placed in contact with the patient's abdomen close to an abdominal incision.

The prosthetic device is characterized in that it comprises a tubular connection member coaxially anchored to said connector close to said annular end edge, said connection member having a substantially cylindrical wall insertable in the abdominal incision with a first support zone for a first suture of connection to a section of the intestinal tube and a second support zone for a second suture of connection to the abdominal incision. Thanks to this particular configuration, it will be possible to secure the device to the body of the patient without it being necessary to suture it to the skin, thus obtaining a colostomy of prosthetic, non-cutaneous type which will allow considerably reducing the onset of medical complications such as dermatitis or the like.

According to a further aspect of the finding, a feces collection container is provided, in accordance with claim 12, connectable to the aforesaid prosthetic device.

According to yet another aspect of the finding, an assembly for colostomy is provided, in accordance with claim 15, comprising at least one feces collection container and at least one prosthetic device according to the finding. Advantageous embodiments of the finding are obtained in accordance with the dependent claims.

Brief Description of the Drawings Further features and advantages of the invention will appear more clearly from the detailed description of preferred but non-exclusive embodiments of a prosthetic device for colostomy and of a container for the feces collection applicable to the prosthetic device according to the finding, illustrated as a non- limiting example with the aid of the attached drawings, in which:

FIG. 1 is a side view in section of a device for colostomy according to the prior art;

FIG. 2 is a partially sectioned perspective view of a prosthetic device for colostomy according to the finding in a first preferred configuration;

FIG. 3 is a perspective view in section of the device of FIG. 2;

FIG. 4 is a view in section of the device of Fig. 2 applied to a patient; FIG. 5 is a view in section of a prosthetic device for colostomy in a second preferred configuration;

FIG. 6 is a view in section of a prosthetic device for colostomy in a third preferred configuration;

FIG. 7 represents an application sequence of the device of Fig. 6;

FIG. 8 is a partially sectioned side view of a container according to the finding.

Detailed Description of a Preferred Embodiment

With reference to the mentioned figures, the prosthetic device for colostomy, generically indicated with 1 , will be intended for use in both temporary and permanent colostomy surgery operations. In such operations, an abdominal incision B is made in the abdomen H of a patient in order to deviate a section C of the intestinal tube outside the body, in a manner so as to allow the evacuation of the feces.

The prosthetic device 1 for colostomy operations according to the finding comprises a tubular connector 2 suitable for being connected to a feces collection container 3, illustrated in Fig. 8, and having an annular end edge 4 designed to be placed in contact with the abdomen H of the patient close to an abdominal incision B.

In addition, according to a distinctive feature of the invention, the connector 2 is coaxially anchored to a tubular connection member 5 in proximity to its annular end edge 4.

The connection member 5 has a substantially cylindrical wall 6 insertable in the abdominal incision B, having a first support zone 7 of a first suture W-i for connection to a section C of the intestinal tube and a second support zone 8 of a second suture W ₂ for connection to the abdominal incision B.

The tubular connector 2 will preferably be made of any polymer material, even rubber or silicon material, suitable for coming into contact with the human body, and possibly but not necessarily suitable for being sterilized in autoclaves and/or under cold conditions.

Preferably, its annular end edge 4 will be substantially flat, in order to come into contact with the skin D by means of simple abutment.

Suitably, the connector 2 will be substantially rigid or semi-rigid in order to be easily handled by an operator, with an internal peripheral surface 9 that is substantially cylindrical and delimiting a central passage 10. The tubular connection member 5 will preferably be flexible, so that it can be easily inserted inside the abdominal incision B and in order to be fixed by means of the sutures W-i and W ₂ to the anatomical parts of the patient.

In particular, the connection member 5 can have a net, mesh or even porous structure in order to enhance the contact between the abdominal wall H and the derived intestinal tube section C, in a manner so as to promote the growth of biological tissues when the device 1 must be used in a permanent or in any case prolonged form. Suitably, the tubular connection member 5 will have axial length l-i greater than that l ₂ of the connector 2, in a manner so as to project below the same.

In addition, its upper end edge 11 will be contained inside the central tubular passage 10 of the connector 2. In a first embodiment, illustrated in Fig. 2, the anchoring between the connector 2 and the connection member 5 will be obtained at an annular intermediate portion 12 of the latter, close to its upper edge 11. In this manner, the upper edge 11 will be radially free with respect to the internal peripheral surface 9 of the connector 2 in order to be handled by the operator and allow the application of the first suture W-i for connection to the intestinal tube section C. In particular, as is more clearly shown in Fig. 4, in this manner the free end of the intestinal tube section C can be bent on the upper edge 11 of the connection member 5, which will define the first support zone 7, and fixed to the same by means of the suture W-i . Thus, the intestinal tube section C will always remain contained inside the connector 2, preventing its contact with the outside.

The second suture zone 8 can instead be defined by a second annular portion arranged below the anchorage portion 12; such second annular portion can also be suitably shaped, e.g. convex, in order to facilitate the application of the second suture W ₂ .

The cylindrical wall 6 of the connection member 5 can have substantially constant thickness along its entire axial extension with possible localized increases, particularly at the annular intermediate portion 12, so as to compensate for possible thickness reductions due to the anchorage and to provide the correct amount of material for promoting the new growth of intestinal tube biological tissue. In an alternative embodiment, illustrated in Fig. 3, the anchoring between the connection member 5 and the connector 2 can be carried out above the annular portion 12 with increased thickness.

This latter portion will possibly project downward with respect to the end edge 4 of the connector 2 and will have a substantially radial upper surface 13 projecting inward in order to define the first support zone 7 for the first suture W,.

The anchoring between the connection member 5 and the connector 2 will be obtained at the upper tubular portion 14 of the former, possibly but not necessarily with its upper end edge 11 also in this case not bound to the internal peripheral surface 9 of the connector 2, so as to be free.

In another embodiment, illustrated in Fig. 5, the upper tubular portion 14 of the connection member 5 will instead be embedded in the material of the connector 2.

Advantageously, both in the case of Fig. 3 and Fig. 5, the upper tubular portion 14 of the connection member 5 will be made of a first base material that is biologically non-absorbable, but in any case suitable for coming in contact with the human body, in order to mutually isolate the first suture zone 7 from the connector 2.

In this manner, growth of intestinal tube biological tissues also on this portion of connection member 5 will be avoided, preventing the fecal bacteria from moving to the connector 2, from here to the abdomen H and subsequently inside the patient's body.

The remaining part 15 of the connection member 5 will instead be made of a third biologically absorbable material in order to allow the contact between the abdominal wall H and the derived intestinal tube section C and to enhance biological tissue growth.

In merely exemplifying manner, the second material can be selected from among polymer materials, such as polypropylene or the like.

In an alternative embodiment, illustrated in Fig. 6, an annular isolation sleeve 16 can be provided that is made of a second biologically non-absorbable material, possibly equivalent to the first material; such sleeve is fixed inside the connector 2, coaxially superimposed on the upper portion 14 of the connection member s.

Fig. 7 illustrates an operative sequence of coupling via suture of the derived intestinal tube section C with the connection member 5. Such sequence, even if referred to the configuration of Fig. 6, can also be applied to the device 1 of Figs. 4 and 5.

It is observed in the figure that the operator, after having inserted the terminal portion of the derived intestinal tube section C inside the device 1 , will bend the end edge thereof outward and will carry out the fixing via the application of a plurality of suture stitches W-i .

The latter will be configured so as to cross through both the annular intermediate portion 12 with increased thickness of the connection member 5 and the intestinal section C, before being closed on the radial surface 13 of the former.

In this manner, a stable and bacterially isolated coupling will be obtained, also due to the presence of the annular upper portion 14 or of the sleeve 16 in a suitable first material. According to a further aspect, the connection member 5, on an internal or preferably external peripheral surface thereof, can have a graduated scale (not shown in the futures) in order to allow the possible reduction of its axial length l-i, so as to adapt it to the thickness of the abdominal incision B of the patient subjected to colostomy.

In addition, the tubular connector 2 will have a threaded surface 17, e.g. the external peripheral surface thereof, for its removable coupling via screwing with a counter-threaded portion 18 of a collection container 3.

Fig. 8 illustrates a container 3 for the feces collection that can be coupled to the prosthetic device 1.

The container 3 comprises a containment chamber 20 for the feces having an opening 21 for the passage of the feces and means 22 for the removable anchoring of the chamber 20 to the tubular connector 2 of the prosthetic device 1.

In particular, in the illustrated configuration, the anchorage means 22 will comprise the aforesaid counter-threaded portion 18 of the internal surface 23 of the chamber 20 arranged near its opening 21 in order to allow the coupling by means of screwing to the threaded surface 17 of the tubular connector 2.

Nevertheless, the anchorage means 22 could be configured differently, e.g. as a snap-on bayonet or as a simple male and female coupling, also as a function of the connector configuration 2.

The collection chamber 20 can also have suitable valve means (not shown) which are adapted to allow the controlled outflow of intestinal gases present therein. In a merely exemplifying manner, the valve means can comprise a crescent- shaped valve applied to the opening 21.

The device, the container and the assembly according to the invention are susceptible to numerous modifications and variants, all falling within the inventive concept expressed in the enclosed claims. All the details can be substituted by technically equivalent elements, and the materials can be different as required, without departing from the scope of the invention. Even if the device, the container and the assembly were described with particular reference to the enclosed figures, the reference numbers used in the description and in the claims are used for improving the intelligence of the invention and do not constitute any limitation of the claimed scope of protection.