BE899910A - MECHANICAL VALVE FOR CLOSING A SKIN STOMA. - Google Patents

Abstract

Mechanical stomach valve, giving the patient the possibility of intestinal transit at desired time intervals. Such a valve comprises a support element inside the valve, flat and annular. The valve is placed outside the patient's body. This flat and annular inner support element is crossed by the saturated colon around the edge of the hole in the abdominal wall and fixed by sutures to the outer face of the muscle layers.

Description

       

  Mechanical valve to close a stoma

  
The invention relates to a mechanical valve of a stoma giving a patient the possibility of intestinal transit

  
at desired time intervals. Such a valve comprises an inner, flat and annular valve support element.

  
The valve is placed outside the patient's body. The flat and annular inner support element is crossed by

  
the colon sutured around the edge of the hole in the abdominal wall and fixed by sutures to the outside of the muscle layers.

  
The word nstoma "is commonly used to signify an artificial grip of a segment of the gastroenteric tube by its outer layer (cutis) so as to allow the materials it contains to leave it.

  
A stoma can be obtained by two methods, namely:

  
A. A partial stoma - when the material of the intestine is

  
only partially transported to the outside, allowing continuity of the segment concerned.

  
B. A total stoma - when we take the whole circumference

  
whole segment concerned thereby interrupting transit.

  
Stomas can belong to the entire gastroenteric tube. Thus, one can obtain the following stomas:

  
stomach stoma (gastrostoma), duodenum (duodenostoma), jejunum (jejunstoma), ileum (iliostoma), colon
(colostoma).

  
We can also prepare stomas at the request of one case or the other with a temporary or permanent effect. However, the surgical preparation differs according to the technical means adopted.

  
The present invention relates to a mechanical valve of a stoma, giving the patient the possibility of intestinal transit at desired time intervals.

  
such a valve comprises a support element inside the valve, flat and annular; the valve is placed outside the patient's body. This flat and annular interior support element is crossed by the colon sutured around the edge of the hole of the abdominal wall and fixed by sutures to the external face of the muscular layers.

  
In the drawings:

  
- Figure 1 is a top view of the assembled valve, with a sectional view of the abdominal wall to which it is applied;
- Figure 2 is a diametrical section of the claimed valve, still in the assembled position, as shown in Figure 1;
- Figure 3 is a front view of the valve;
- Figure 4 is a front view of the valve support flange; this strap will be fixed inside the abdominal cavity, as explained below;
- Figure 5 is a sectional view of the flange along the line V-V of Figure 4;
- Figure 6 is, on a larger scale, a partial view along line VI-VI of Figure 4;
- Figure 7 is a view along line VII-VII of Figure 6;
- Figure 8 is a front view of the valve part to be fixed on the support flange, although resting in an external position;

   this valve part will hereinafter be called "tubular body with external flange";
- Figure 9 is a section taken along the line IX-IX of Figure 8; - Figure 9A is a section showing and completing detail IX of Figure.9;
- Figure 10 is a front view of the valve part playing the role of "valve body", name which will be given in the following of this description;
- Figure 11 is a section along the line XI-XI of Figure 10;
- Figure 12 is a section along line XII-XII of Figure 10;
- Figure 13 is a perspective view of the valve shutter, produced in this case as a curtain shutter;
- Figure 14 is a section along the line XIV-XIV of Figure 13;
- Figure 15 is an axial section of a spindle which, in correspondence with its end, is drilled and tapped;

   it will be called in the following the vent pin;
- Figure 16 is an enlarged detail of the previous figure and refers to the drilled and tapped part of the vent pin;
- Figure 17 is an axial section of a connecting pin between the lower support flange and the tubular body with outer flange;
- Figure 18 shows a fixing screw intended to immobilize the outer tubular body with flange relative to the inner support flange, via the connecting pin;
- Figure 19 is an alternative embodiment of the flanged tubular body already shown in Figure 8;
- Figure 20 is an enlarged view of the previous figure;
- Figure 21 is a sectional view of the first variant in the embodiment of the present invention;

   - Figure 22 is a partial view, limited to the flange valve body and to the cover of a second alternative embodiment of the invention;
- Figures 23 and 24 show a connecting pin between the inner flange and the valve body and, on the same scale, the plastic sheath to be threaded on the pin, in order to promote the adhesion of a new fabric on the spit, examining the alternative embodiments of Figures 21 and 22.

  
Referring more particularly to the figures, it can be seen that the valve placed outside is constituted by the tubular flange body 10 which has a flange 11 through which a number of holes 12 pass, -four in the embodiment given to as an example, and which is provided in addition with a tubular body 13 advancing towards the outside and threaded on the outside. The tubular body 13 is equipped on its free edge with at least one slot 14 intended to accommodate a seal 15 (an O-ring for example), as shown in FIG. 2.

   In addition, the flanged tubular body 10 has an annular bead 16 whose section gradually decreases towards its free edge and which is curved towards the axis of the body 10, as can be seen in detail in FIG. 9, this provision being provided on the inner face of the flange 11, namely on the face opposite to that which projects relative to the tubular body 13. The role of the annular bead 16 is to ensure a seal between the inner face of the flange 11 and the skin of the patient against whom the strap in question must bear. The inclination of the aforementioned bead makes it possible to obtain a seal which is all the more effective the higher the pressure inside the bead compared to the pressure outside.

  
Referring more particularly to FIG. 9A, it can be seen that the wall of the tubular body 13 is traversed radially by a tapped hole 17 passing right through.

  
This hole is intended to accommodate the vent pin 20, or more precisely its threaded end part. As is evident from Figure 15 and as shown in more detail in Figure 16, the threaded end of the vent pin 20 is traversed by a first axial passage 21 and by a second diametrical passage 22; this second diametrical passage 22 is provided at the base of the threaded segment of the vent pin so as to allow communication between the inner part of the tubular body 13 and the outside only when the vent pin is partially unscrewed.

  
The valve body 30 is constituted by two cylindrical segments 31 and 32 arranged coaxially and successively crossed by a hole 33 of large diameter. Hole 33 only has a 180 degree arc as it extends like a loop hole through the wall of the valve body
30 due to a box 34 which allows the insertion and sliding of a curtain shutter 40.

  
The larger diameter cylindrical segment 32 of

  
valve body 30 is tapped and is suitable for being screwed onto the tubular body 13 of the flanged tubular body 10.

  
The outer cylindrical segment 31 whose diameter is less than that of the valve body 30 is provided, on its edge oriented towards the slot 33 and to receive the curtain 40, an annular slot 35 suitable for receiving a seal
(an O-ring for example) designated by 36 in Figure 2.

  
It follows that when the valve body 30 is screwed onto the tubular segment 13 of the flanged tubular body 10, the curtain or register of the valve achieves a sealed closure due to the presence of the two seals
15 and 36. However, it will be observed that these seals can be omitted in the case where the machining of the curtain 40 and of the slot 33 which houses it is sufficiently advanced.

  
Finally, the curtain 40 is preferably provided with a short flange 41 which allows it to be grasped and put in place more easily. The remaining part is a flat plate representing a main semi-circular region and a secondary region of substantially rectangular shape.

  
Proper sizing of parts 40, 10

  
and 30 allows the curtain 40 to remain, by friction, in the pre-arranged position which it is given from time to time by means of the flange 41, without it being necessary to apply considerable forces to the curtain for the 'extract and replace it.

  
The larger diameter tubular part or inner part 32 of the valve body 30 is provided, behind the box 34, with a notch 37 to allow access from

  
the vent pin 20 to the threaded hole 18 of the flange 11 of the flanged tubular body 10. The operation of the valve
10-30-40-20 is easy to understand: when the vent pin 20 is screwed and when the curtain 40 is pushed against the bottom of the slot 33, the valve, which is to be considered as a simple interception element , is closed. When the vent pin 20 is unscrewed, the valve allows gas to flow from the inside to the outside. Consequently, to allow that through the hole 18 born to flow

  
as gases and not liquids, it is advisable to assemble the body 30 with the hole 18 facing upwards. The partial or total opening of the curtain 40 will on the contrary allow the flow of liquids as well as solids. The parts described above represent only a preferred embodiment of the valve itself representing an interception member to be used, according to the invention, outside the patient's body. It is clear that possible variations can be provided in the embodiment of the system 10-30-40-20, while the particular characteristic of the invention lies in the means used to fix the effective valve with movement of opening and closing, to the patient's body, thanks to an internal support flange 50.

   This internal support flange 50 consists of a flat ring to be fixed to the external face of the abdominal muscle after having fixed the wall of the colon 61, by sutures, to the peritoneum 60 and to the abdominal muscle, and before having fixed the wall 61 of the settler at

  
the skin 63. Proper placement of the internal support disc is carried out using stitches to the abdominal muscle 62, using the suitable passages 51 distributed along a circumference on the wall of the internal support flange 50. It ensues that the mechanical valve claimed is substantially constituted by an interior part in the abdomen of the patient, formed by the interior support flange 50, and by an exterior flange producing the valve proper 10-20-30-40.

  
To secure the two parts inside or outside the claimed valve, different solutions can be adopted. According to the embodiment of the internal support flange 50 shown in FIG. 17, a suitable number of connecting pins 70 extend through the layers 63, 64 and 62, continuously fixed to the internal support flange 50 and provided,

  
on the outside, connecting means with blocking elements such as screws 71 to be screwed into the tapped axial hole 72 provided in advance in the outside of the connecting pins 70.

  
It is obvious that these pins pass through not only the layers 62 and 64 but also the thickness of

  
the flange 11 of the flanged tubular body 10 thanks to the corresponding passage holes 12.

  
The solution shown in the figures, which, in addition to the screws 71, provides pins drilled and tapped at their outer end, makes it possible to adjust the clamping force which, by pushing through the flanges 11 and 50, presses

  
the muscle and the adipose layers 62, 64 and the skin 63 of the patient, also taking into account any thickness changes that may occur in these layers.

  
 <EMI ID = 1.1>

  
inner support can be produced as shown in FIGS. 4, 6 and 7. The flat ring 50 has notches
54 into which an extended foot 73, of complementary shape, can be introduced. In addition, the axial section of the holes 55, through which each pin 70 must pass, can have a variable dimension to facilitate the final insertion of the pin 70 through the holes 55.

  
A simpler choice, the construction of which is however very complicated, ensures the incorporation of the connecting pins 70 into the flange 50. It is obvious that the pins 70 must pass through the layers 62, 63 and 64. A possible variant of the system connection between the inner support flange 50 and the flange 11 of the tubular flange body 10 can be achieved by a pair of magnetic rings cast in the thickness of the flanges 11 and 50 and capable of creating a high clamping force.

  
With particular reference to the variant

  
of form. shown in Figures 19 and 20, the tubular flange body 110 is also provided in this case with a cylindrical part 113, a flange 111 and a seal
116. In addition, and according to the variant shown, the tubular wall 113 has a cushion 80 housing a tapped hole with large pitch 84 in which a threaded pin 85 advances in the lower part from a small cylinder 86

  
lends itself to be easily grasped by the patient and to be notably lifted (for example 1 mm) by carrying out a relatively limited rotation (for example 180 degrees). The lower end of the small cylinder 86 is conical and is housed in a seat of corresponding conicity 83. Consequently, when the spindle 86 is screwed in fully, the seal is established.

  
A small channel 82 enters the conical seat by being connected to the tubular body with an inner flange 110 by a porous body with open cells acting as a filter.

  
This filter can be welded to the flanged tubular body
110 and it can therefore be made of a different material.

  
It is obvious that at the outer orifice of the valve itself, one can place a removable, resistant and thin bag.

  
With particular reference to the figures

  
21 to 24, the following numbers 60, 61, 62, 63 and 64 respectively identify the colon, the peritoneum, the abdominal muscle, the outer fat layer and the cutis.

  
The internal support flange 50 is inserted between the abdominal muscle 62 and the adipose layer 64.

  
Pins 70 fixed beforehand to the inner support flange 50 pass through the inner layers 64 and 63 and project relative to the cutis so that they can be used for coupling the valve body 210 through suitable holes 212 provided in the advance on the flange 211 of the valve body 210.

  
According to the embodiment shown in the figure
21, the valve body 210 has a tubular part 213 with external threads, onto which a hollow plug 214 can be screwed.

  
To facilitate the removal of intestinal residues, a thin, flexible, multi-ply waterproof bag is introduced into the tubular body 213, a slot 215 being provided to accommodate a reinforcement ring at the edge of the bag, placed above the nets. exteriors. According to this embodiment, no gas escape is provided for the evacuation of these separately from the intestinal residues.

  
However, the valve according to the invention is extremely simple both in terms of its construction and its operation.

  
According to the embodiment shown in the figure
21, the seal of the lip 216 is perfected by an O-ring 217 and, in addition to this, another O-ring 218 is provided between the seal of the plug 214 and the tubular part 213, at the end of the thread.

  
The embodiment mentioned above, shown in FIG. 21, shows that the pins 70 can be externally threaded so that their end which projects out from the flange 210 can receive a cap nut 271.

  
To allow the adhesion of the fabric around the pin 70, as shown in Figure 4, the latter is coated, before the operations, with a polyethylene terephthalate pipe in the form of gauze, 70 ', which has been found to be constitute a good support in the process of cell formation.

  
In the embodiment shown in Figure 22, the valve body 310 is similarly unchanged, except that the tubular threaded body 311 is shorter.

  
In this case, there is no bag fixed in sealed manner to the edge of the tubular body and the seal is provided by an O-ring 312 housed inside a slot corresponding to the inner face of the hollow plug. The absence of the bag used in FIG. 21 however allows the mounting of a relief valve 315, composed of a push button 316 fixed to a pin 317 which passes through the hollow plug. At the opposite end is mounted a shutter head
318.

  
A spring keeps the shutter head 318 tight on its seat and the evacuation of the gases takes place only when the push button has been pushed for this purpose. A seal 320 is introduced between the patient's skin and the flange 311 of the valve body 310. This provides sealing in a variant of

  
the elastic lip 216 associated with the O-ring 217, as shown in FIG. 21.

CLAIMS

  
1.- Mechanical valve to close a cutaneous stoma to give the patient the possibility of allowing the intestinal transit to operate at desired time intervals, characterized in that it comprises an internal support element of the valve proper, placed at the exterior of the patient's body, the interior support element being traversed by the colon which is sutured around the edge of the hole in the abdominal wall and which is fixed to the exterior face of the muscular layers by means of sutures.


    

Claims (1)

2. Mechanical valve according to claim 1, characterized in that the internal support element of the valve proper, placed outside, is made of a flattened ring, with rounded edges, and provided with holes arranged in a circumference to allow the stitches to reach the muscle layers. 3. Mechanical valve according to claim 2, characterized in that there are provided in suitable number of coupling pins regularly arranged along a circumference and advancing from the patient's body by crossing the adipose tissue and the skin of the abdominal wall, so that their projecting ends can be used to fix the valve itself which is placed outside. 4.- mechanical valve according to claims 1 and 2, characterized in that the valve itself, placed outside the patient's body, is provided with a clean flange to be superimposed, by interposing the thickness of the tissue adipose and from the skin of the abdominal wall, to the internal support flange, and suitable for cooperating with the coupling pins which start from the latter by projecting from the abdominal wall. 5. Mechanical valve according to claims 1, 2 and 3, characterized in that the coupling pins pass through the corresponding hole each time of the valve itself, placed outside, a corresponding number of screws being suitable for being screwed into the connecting pins to achieve the necessary clamping force between the two flanges. 6. Mechanical valve according to claim 4, characterized in that the flange of the valve itself is provided, on the side facing the patient's skin, with at least one seal. 7. Mechanical valve according to claim 6, characterized in that the seals are permanently fixed or welded to the inner face of the mentioned flange, their radial section being thinned from bottom to top and converging towards the axis of the valve. so as to form a joint whose efficiency increases with increasing internal pressure. 8. Mechanical valve according to any one of the preceding claims, characterized in that the valve proper, placed outside, comprises a tubular flanged body in which the cylindrical part can receive a valve body through which a slot passes. transverse allowing the movement of coming and going of a curtain shutter. 9. A mechanical valve according to claim 8, in which the cylindrical part of the flanged tubular body has at its base, that is to say near its flange, a hole possibly leading to a filter, to receive a pin. Wind. 10.- Mechanical valve according to claim 9, characterized in that the filter consists of an insert of a porous material with open cells, preferably polyurethane or a similar plastic material. 11. A mechanical valve according to claim 1, characterized in that an internal support flange is provided provided with pins advancing towards the outside to be introduced and fixed in the thickness of the fabric, a valve body being externally fixed by pins to the internal support flange, and the valve body having an annular flange and a tubular body with external threads to receive a hollow plug. 12.- Mechanical valve according to claim 11, characterized in that an annular slot is provided on the tubular edge of the valve body, adapted to receive the elastic edge reinforced with a flexible bag which can be folded to be introduced into the tubular body of the valve body before closing the cap. 13. A mechanical valve according to claim 11, characterized in that the bottom of the body of the hollow plug has an annular slot for accommodating an O-ring capable of being pushed against the annular end of the tubular body of the valve body. 14.- Mechanical valve according to claim 11, characterized in that the annular flange of the valve body comprises a sealing lip which is held retracted in the position of maximum efficiency by an O-ring. 15.- Mechanical valve according to claim 11, characterized in that the annular flange of the valve body has a region equipped with annular teeth, bearing against a suitable seal of the same shape, interposed between the patient's bridle and epidermis. 16.- Mechanical valve according to claim 11, characterized in that the pins protruding from the inner support flange are externally threaded and clean to receive cap nuts. 17. A mechanical valve according to claim 16, characterized in that the pins are coated with a polyethylene terephthalate sheath to facilitate the attachment of fresh tissue to the surface of said pins.