FR2548015A1 - MECHANICAL VALVE FOR CLOSING A SKIN FISTULA GIVING THE PATIENT THE INTESTINAL TRANSIT FACILITY AT TIME INTERVALS - Google Patents

Abstract

THE OBJECT OF THE INVENTION IS A MECHANICAL VALVE FOR FISTULA GIVING THE PATIENT THE FACULTY OF INTESTINAL TRANSIT AT THE DESIRED TIME INTERVALS. SUCH A VALVE INCLUDES AN INTERNAL, FLAT AND ANNULAR ELEMENT 50 OF SUPPORT FOR THE VALVE 10, 30, 40 AND THE VALVE IS LOCATED OUTSIDE THE PATIENT'S BODY. THROUGH THE FLAT RING INTERNAL SUPPORT ELEMENT 50 IS CROSSED BY THE COLON SUTURE AROUND THE EDGE OF THE HOLE OF THE ABDOMINAL WALL AND FACING THE OUTSIDE OF THE MUSCLE LAYERS BY MEANS OF SUTURES.

Description

The object of the present invention is to provide a mechanical valve for

  fistula giving the patient the faculty of intestinal transit at desired time intervals. Such a valve has a flat, annular internal element for supporting the valve. The valve is placed outside the patient's body. Said flat and annular internal support element. is crossed by the colon sutured around the edge of the hole

  from the abdominal wall and attached to the outside of the muscle layers with sutures.

  The word fistula usually designates the artificial delivery of a segment of the gastroenteric tube with the layer

  outer (dermis) operated to allow the exit of the materials present in said tube.

  Fistulas can be produced by two methods, namely: (A) partial fistula when only the intestinal material is transported outward, respecting the continuity of the segment concerned; (B) total fistula when the delivery covers the entire periphery of the segment concerned, which interrupts transit. Fistulas can be formed over the entire gastroenteric tube. The following fistulas can thus be produced: stomach (gastrostomy), duodenum (duodenostomy), jejunum (jejunostomy), ileum (ileostomy), colon (colostomy). Fistulas with a temporary or permanent effect can still be used, depending on the case. However, the preparation

  differs according to the technical means adopted.

  The present invention relates to a mechanical valve

  for fistula giving the patient the capacity of intestinal transit at desired time intervals.

  Such a valve comprises a flat and annular internal element for supporting the valve; the valve is placed outside the patient's body The said internal support element is crossed by the colon sutured around the edge of the hole in the abdominal wall and fixed to the outside of the layers

muscles using sutures.

  In the accompanying drawings: FIG. 1 is a top view of the assembled valve and of a fragment of the abdominal wall on which the valve is placed; Figure 2 is a diametrical section of the re5 valve sold, also in the assembly position shown in Figure 1; Figure 3 is a front view of the valve; FIG. 4 is a front view of the valve support flange, which flange is to be fixed inside the abdominal cavity as will be explained below; 5 shows the flange in section along the line V-V of Figure IV; Figure 6 is, on a larger scale, a partial view along the line VI-VI of Figure 4; Figure 7 is a view along the line VII-VII of Figure 6; FIG. 8 is a front view of the valve part to be fixed on the support flange, although it rests in the external position, valve part which will be called hereinafter tubular body with external flange; Figure 9 is a section along the line IX-IX of Figure 8; FIG. 9A represents the detail indicated in 9 / in FIG. 9; FIG. 10 is a front view of the valve part acting as a "valve body", the name by which it will be designated hereinafter in this specification; FIG. 11 is a section along line XI-XI of the Figure 10; Figure 12 is a section along line XII-XII of Figure 10; Figure 13 is a perspective view of the valve shutter, in this case made as a sliding shutter; Figure 14 is a section along the line XIV-XIV of FIG. 13; FIG. 15 is an axial section of a finger with a reamed and tapped end which will be referred to hereinafter as "vent finger"; FIG. 16 is enlarged detail of the previous figure and relates to the bored and tapped part of the vent finger; Figure 17 is an axial section of a connecting finger between the internal support flange and the tubular body with external flange; Figure 18 represents a fixing screw intended to fix the tubular body with external flange against the support flange i ntérieur via the connecting finger; FIG. 19 shows a variant of a flanged tubular body already shown in FIG. 8; FIG. 20 reproduces with magnification part of the previous figure; Figure 21 is a cutaway view of the valve according to the first embodiment of the present invention; FIG. 22 is a partial view, limited to the flange valve body and to the cap of a second variant of the invention; Figures 23 and 24 show a connecting finger between the internal flange and the valve body and, on the same scale, the plastic sheath to be inserted on this finger to promote adhesion of new tissue to

  finger according to the variants illustrated in FIGS. 21 and 22.

  We will now describe a preferred embodiment with reference to the drawings; the valve placed on the outside is constituted by a tubular flange body 10 which has a flange 11 crossed by a certain number of suitable holes 12, four in number in the embodiment, as well as a tubular body 13 projecting outwardly and externally threaded The tubular body 13 has in its free edge at least one groove 14 intended to receive a seal 15 (for example O-ring), as shown in FIG. 2 In addition, the body with tubular flange 10 has an annular lip 16, the section of which gradually decreases towards its free end and which is bent towards the axis of the body 10, as shown in detail in FIG. 9, this lip being provided on the inner face of the flange 11, that is to say on the opposite face of the tubular body 13 The role of the annular lip 16 is to ensure the seal between the inner face of the flange 11 and the skin of the patient against which the flange in question; the inclination of the aforementioned lip makes it possible to obtain a seal which is all the more effective as the pressure prevailing internally at the

  lip is strong compared to external pressure.

  The wall of the tubular body 13 is traversed radially right through by a tapping l 8 This tapping is suitable for receiving a vent finger 20, or more precisely its threaded end portion As can be clearly seen in the figure and in more detail in FIG. 16, the threaded end of the vent finger 20 is crossed by a first axial passage 10 21 and by a second diametral passage 22; this second diametrical passage 22 is placed at the foot of the threaded segment of the vent finger so as to allow communication between the inner part of the tubular body 13 and the outside, only when the vent finger is partially unscrewed The valve body 30 consists of two cylindrical segments 31 and 32, coaxial and consecutive, separated by a bore 33 of larger diameter The bore 33 covers only one

  arc of 180 since it extends an opening made through the wall of the valve body 30, thanks to a casing 34 which allows the insertion and the sliding of a sliding shutter 40.

  The larger diameter cylindrical segment 32 of the valve body 30 is tapped and suitable for screwing onto the

  tubular body 13 of tubular flange body 10.

  An outer cylindrical segment 31 of smaller diameter than the valve body 30 is provided on its edge oriented towards

  the groove 33 and suitable for receiving the sliding shutter 40 and has an annular groove 35 suitable for receiving a seal (for example an O-ring) designated by the reference 36 30 in FIG. 2.

  It follows that when the valve body 30 is screwed onto the tubular segment 13 of the tubular flange body 10, 1 '

  sealing of the sliding shutter is rigorously ensured by the two seals 15 and 36 However, it will be noted that 35 it is also possible to remove these seals in the event that the machining of the shutter 40 and of the groove 33 which receives it is sufficiently specific.

  Finally, the shutter 40 preferably has a short flange 41 allowing it to be easily grasped and put in place. The rest of the shutter is constituted by a flat plate having a semicircular primary zone.

  and a secondary zone of substantially rectangular shape.

  Proper positioning of parts 40, 10 and 30 must allow the shutter 40 to remain temporarily, for

  friction, in the predetermined position thanks to the rim 41, without great efforts being necessary for its extraction and its insertion.

  The larger diameter tubular or internal part 32 of the valve body 30 has, behind the casing 34, a notch 37 intended to offer the vent tube 20 access to the thread 18 of the tubular body 11 of the flange tubular body 10 Le operation of the valve 10-30-40-20 is easy to understand; when the vent tube 20 is screwed and the shutter 40 is pushed against the bottom of the notch 33, the valve, hitherto considered as a simple interception element, is closed; during a partial unscrewing of the vent tube 20, the valve allows the flow of gas from the inside to the outside of the valve; consequently, in order to allow only the flow through the hole 18 of gas and not of liquids, it is advisable to assemble the body by turning the hole 18 upwards The partial or total opening of the shutter 40 allows against the flow of both liquid and solids The parts described above 25 represent only a preferred embodiment of the valve itself, intended to constitute an interception member to be used, according to the invention , outside the patient's body It is clear that modifications may be made, if necessary, to the construction of the system 10-3030 40-20; in fact, the particular characteristic of the invention resides in the means used to allow the fixing of the opening-closing valve on the patient's body, thanks to an internal support flange 50 This internal support flange 50 is constituted by a flat ring to be fixed to the outer face of the abdominal muscle after having fixed by wall sutures the wall 61 of the colon to the peritoneum 60 and to the abdominal muscle and before having fixed the wall 61 of the colon to the skin 63 adequate placement of the internal support disc on the abdominal muscle 62 by means of stitches, using appropriate passages 51 distributed in a circle on the wall of the internal support flange 50 It follows that the mechanical valve claimed is substantially consisting of an internal part, situated in the patient's abdomen and made of the internal support flange 50, and of an external flange constituting the valve properly

called 10-20-30-40.

  In order to ensure the attachment of the two parts, either inside or outside the claimed valve, different solutions can be adopted. According to the embodiment of the internal support flange 50 illustrated in FIG. 2, a number suitable of connecting fingers 70 protruding through the layers 63, 64 and 62 firmly fixed to the internal support flange 50 and having external connection means for locking parts, such as screws 71, which are screwed into the axial thread 72, formed in advance in the outer part of the connecting fingers It is clear that these fingers not only pass through the layers 62 and 64 but also through the thickness of the flange 11 of the tubular flange body 10 thanks to the holes corresponding passage 12 The solution presented in the figure which provides, in addition to the screw 71, bored and tapped connecting fingers at their outer end, allows the clamping force to be graduated which, by thrust transmitted p ar flanges 25 11 and 50, press the muscle as well as the adipose layers

  62, 64 and the patient's skin 63 to an extent which takes account of accidental thickness variations which may appear in these layers.

  The firm connection of the fingers 70 to the flange of the internal port 30 can be operated as shown in FIGS. 4, 6 and 7; the flattened ring 50 has elongated notches 54 into which an elongated foot of complementary shape 73 can be inserted; in addition, the axial section of the holes which each finger 70 must pass through may have a pitch

  variable to facilitate the final insertion of the finger 70 through the holes 55.

  A simpler option, the structure of which is however

  very refined, plans to incorporate the connecting fingers 70 to the flange 50 It is obvious that the fingers 70 must

  wind cross layers 62, 63 and 64 A possible variant of the connection system between the internal support flange 50 and the flange 11 of the flanged tubular body 10 can be constituted by two magnetic rings incorporated in the thickness of the flanges 11 and 50 and capable of generating a sufficiently large clamping force. Referring in particular to the variant illustrated in FIGS. 19 and 20, the tubular flange body 110 also has in this case a cylindrical part 113, a flange 111 and a joint 116. 10 In addition and according to the illustrated variant, the tubular wall 113 has a boss 80 in which is formed a tapping with large pitch 84, in the lower part of which penetrates a threaded finger 85 starting from a small cylinder 86 that the patient can easily grasp and raise over a fixed distance 15 (for example of a millimeter) by imparting to him a relatively limited rotational movement (for example of 180) The lower end of the small cylinder 86 is frustoconical and is housed in a seat with corresponding conicity 83; by

  Therefore, when the finger 86 is fully clamped, the tightness is established.

  In the frustoconical seat opens a small channel 82, connected to the body with internal tubular flange 110 through a

  porous body with open cells acting as a filter.

  Said filter can be welded to the tubular flange body 110 and can therefore be made of a different material.

  It is clear that a removable, thin and resistant pocket can be suitably placed on the external orifice of the valve.

  Reference is made to FIGS. 21 to 24, in which the references 60, 61, 62, 63 and 64 respectively denote

  the colon, the peritoneum, the abdominal muscle, the outer fat layer and the dermis.

  The internal support flange 50 is inserted between the abdominal muscle 35 and the adipose layer 64.

  Fingers 70 previously fixed to the internal support flange 50 pass through the layers 64 and 63 and emerge from the dermis so as to be able to be used to couple the valve body 210 by passing through suitable holes 212 made in advance.

  in the flange 211 of the valve body 210.

  According to the embodiment illustrated in the figure, the valve body 210 has a threaded tubular part 213

  onto which a hollow pad 214 can be screwed.

  To facilitate the removal of intestinal residues, a pleated, waterproof, thin and flexible pocket is inserted inside the tubular body 213 which has a groove 215 intended to receive a reinforcement ring provided on the

  pocket edge and placed above the thread.

  According to this embodiment, there is no provision for purging the gases independently of the removal of intestinal residues; however, the valve according to the invention is extremely simple, as regards both its structure and

its operation.

  According to the embodiment illustrated in FIG. 21, the sealing of the lip 216 is improved by an O-ring 217 and, in addition to this, another O-ring 218 is provided between the closure of the pad 214 and the tubular part.

213, at the end of the thread.

  According to the aforementioned embodiment illustrated by the figure, it is provided that the fingers 70 are threaded on the outside so that their ends protruding from a flange 210

  can receive a cap nut 271.

  In order to allow adhesion of the tissue around the finger 25 70, the latter is coated before the operation, as illustrated in FIG. 24, with a tube 70 ′ made of polyethylene terephthalate fabric which has been found indicated as support in the

cell formation process.

  In the embodiment illustrated by FIG. 22, the valve body 30 remains substantially unchanged except for one

  shorter tapped tubular body 311.

  In this case, there is no hermetically sealed pocket

  fixed to the edge of the tubular body and sealing is ensured by an O-ring 312 housed in a corresponding corres35 groove made in advance on the internal side of the hollow pad.

  The absence of the pocket used in FIG. 21 nevertheless makes it possible to mount a decompression valve 315 composed of a push button 316 fixed on a finger 317 passing through the hollow pad; at the opposite end is mounted a shutter

with head 318.

  A spring keeps the head shutter 318 hermetically applied against its seat and the gas purge does not take place

  only when the push button is deliberately pressed.

  A seal 320 is inserted between the patient's skin and the flange 311 of the valve body 310; it seals in place of the elastic lip 216 associated with the O-ring

217 shown in Figure 21.

Claims (14)

  1 Mechanical valve for closing a skin fistula intended to give the patient the faculty of intestinal transit at the desired time intervals, characterized in that it comprises an internal element (50) for supporting the valve itself (10 20 30 40) placed outside the patient's body, said internal support element (50) being traversed by the colon (61) which is sutured around the   edge of the hole in the abdominal wall (63) and is fixed to the external facet of the muscle layers by means of sutures.   2 Mechanical valve according to the preceding claim, characterized in that said internal element (50) for supporting the valve proper (30), placed ext 6 laughingly, is made of a flattened ring with rounded edges and has holes 15 arranged in a circle (51) intended to allow the points of   suture to reach the muscle layers.   3 mechanical valve according to the preceding claim, characterized in that there is provided a suitable number of coupling fingers (70) arranged in a circle and which protrudes from the patient's body through the adipose tissue and the skin of the abdominal wall so that their protruding ends can be used to fix the valve itself placed outside.   4 Mechanical valve according to the preceding claim, characterized in that the valve proper placed outside the patient's body has a flange (11, 111, 211, 311) capable of being superimposed, with the thickness of the adipose tissue and skin from the abdominal wall, to the internal support flange (50) and to cooperate with the coupling fingers (70) which protrude from   this outside the abdominal wall.   Mechanical valve according to the preceding claim, characterized in that the coupling fingers (70) pass through corresponding holes drilled in the flange (10,110, 35 210, 310) of the valve itself placed outside and in that screws (71) are provided in corresponding number, intended to be screwed into threads (72) formed in the ends of the coupling fingers to allow   exert the desired clamping force between the two flanges.   6 Mechanical valve according to claim 4, characterized in that the flange (11, 111, 211, 311) of the valve itself is present on its side looking towards the skin of the   patient at least one seal (16, 116, 216).   7 mechanical valve according to claim 6, characterized in that said seals (16, 116, 216) are firmly fixed or welded to the inner face of the aforementioned flange (50) and in that their radial section decreases from the base to the top and converges towards the valve axis, so as to form a seal whose efficiency increases when the pressure internal rises.   8 Mechanical valve according to the preceding claims,   characterized in that the valve proper, placed on the outside, comprises a tubular flange body (10, 110, 210, 15 310) of which said cylindrical part (13, 113, 213) can receive a valve body (30 ) crossed by a transverse groove (33) intended to allow transverse displacement of a sliding shutter (40).   9 Mechanical valve according to claim 8, caractéri20 sée in that the cylindrical part of the tubular flange body (10, 110, 210, 310) has at its foot, that is to say near its flange, a hole possibly preceded by   filter (81) and suitable for receiving a vent finger (85).   Mechanical valve according to claim 9, characterized in that said filter (81) consists of a part   reported in porous material with open cells preferably in polyurethane or similar plastics.   11 Mechanical valve according to claim 1, characterized in that it has an internal support flange (11, 30 111, 211, 311), provided with fingers (70) projecting outwards, to be inserted and fixed in the fabric thickness, in that a valve body (30) is fixed externally on said fingers of the internal support flange, in that said valve body has an annular flange (11, 111, 211, 311) and 35 a tubular body (13, 113, 213) threaded to receive a hollow pad (214).   12 Mechanical valve according to claim 11, characterized in that an annular groove (215) is formed on the edge of the tubular body to receive the elastic rim reinforced with a flexible foldable pocket (219) to be inserted in the tubular body of the body valve before closing said stamp (214).   13 Mechanical valve according to claim 11, characterized in that the base of said pad (214) has an annular groove capable of receiving an O-ring capable of being pushed against the annular end of the annular body. valve body.   14 Mechanical valve according to claim 11, characterized in that the annular flange of the valve body has a sealing lip (216) which is kept retracted in the position of maximum efficiency by means of an O-ring. (217)   Mechanical valve according to claim 11, characterized in that the annular flange (311) of the valve body has an area having annular teeth which rest   against a suitable watertight seal (320) of the same shape interposed between the rim and the patient's epidermis.   16 Mechanical valve according to claim 11, characterized in that the fingers (70) projecting from the internal support flange are externally threaded and clean   to receive cap nuts (271).   17 Mechanical valve according to claim 16, characterized in that said fingers are coated with a flexible tube 25 of polyethylene terephthalate, in order to facilitate the anchoring of new tissue on the surface of said fingers.