GB2141346A

GB2141346A - Mechanical valve for closing a cutaneous stoma

Info

Publication number: GB2141346A
Application number: GB08415131A
Authority: GB
Inventors: Luciano Luigi Botta; Michele Steinweg
Original assignee: MULAS PIERO GIOVANNI
Current assignee: MULAS PIERO GIOVANNI
Priority date: 1983-06-15
Filing date: 1984-06-14
Publication date: 1984-12-19
Also published as: ES533401A0; FR2548015A1; GB8415131D0; DE3421001A1; SE8403170D0; NL8401910A; ES8600921A1; SE8403170L

Abstract

In order to enable the patient to open a cutaneous stoma at desired time intervals, the stoma is closed by a valve element 40 in a valve body 30 for securing to the outside of the patient's body (63), and there is an internal, flat, annular support element 50 arranged to be positioned within the patient's body with a portion of the gastroenteric duct 61 passing through the support element 50, the support element 50 also being arranged to be sutured to the outer face of the muscular layers 62 of the patient's body. The gastroenteric duct 61, e.g. the colon, is sutured around the edge of a hole in the abdominal wall 60,62,63. <IMAGE>

Description

SPECIFICATION Mechanical valve for closing a cutaneous stoma Background of the invention The word "stoma" is usually meant for the artificial seizing of a segment of the gastroenteric tube with the outer layer ( cutis) so as to allow exit of the material contained therein.

Stoma can be provided by two methods, namely; (A) partial stoma - when the intestinal material is conveyed only in part to the outside, allowing continuity of the concerned segment.

(B) total stoma - when seizing with the overall circumference of the concerned segementtakes place, thus interrupting the transit.

Stomas can pertain to the whole gastroenteric tube. Thus the following stomas are obtainable, viz.: stomas of the stomach ( gastrostomas), of the duodenum ( duodenostoma), of the jejunum ( jejunstoma) of the ileum (iliostoma) of the colon colostoma).

Stomas can furtherly be prepared on a case by case basis with temporary or permanent effect.

However the surgical preparation differs depending on the technical means adopted.

Object of the invention: The object of the present invention is a mechanical valve of a stoma giving to the patient faculty of intestinal transit at required time intervals.

Summary ofthe invention Such a valve includes an internal flat and annular support element of the valve; the valve is placed outside the patient body. Said internal support element is traversed by the colon sutures around the edge of the hole of the abdominal wall and fastened to the outside face of the muscle layers by means of sutures.

Briefdescription of drawings: Figure 1 is a top view of the valve assembled with a cutaway view of the abdominal wall to which it is applied.

Figure 2 is a diametral 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 support flange of the valve; said flange shall be fastened inside the abdominal cavity as hereinafter explained; Figure 5 is a cutaway view of the flange of which at Figure 4 along line V-V; Figure 6 is, in a wider 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 piece to be fastened onto the support flange, although resting in an outside position; said valve piece shall hereinafter referred to as the outside flanged tubular body; Figure 9 is a section along the line IX-IX of Figure 8; Figure 10 is a front view of the valve piece acting as " valve body", name by which it shall hereinafter referred to in the present specification; Figure 11 is a section along line Xl-Xl of Figure 10; Figure 12 is a section along line Xll-Xll of Figure 10; Figure 13 is a perspective view of the valve shutter accomplished in this case as a gate shutter; Figure 14 is a section al#ong line XIV-XIV of Figure 13; Figure 15 is an axial section of a pin that in correspondence with its end is bored and threaded and that shall be henceforward referred to as " vent pin"; Figure 16 is an enlarged detail of the previous Figure and refers to the bored and threaded part of the vent pin;; Figure 17 is an axial section of a connecting pin between the inside support flange and the outside flanged tubular body; Figure 18 is a fastening screw meant to fasten the outside flanged tubular body against the inside support flange through the connecting pin.

Figure 19 is a variant of embodiment of the flanged tubular body already shown in Figure 8; Figure 20 is an enlarged portion of the precedent Figure; Figure 21 is a cutaway view of the first variant in the embodiment of the present invention.

Figure 22 is a partial view, limited to the flanged valve body and to the cover of a second variant of embodiment of the invention.

Figures 23 and 24 show a connecting pin between the internal flange and the valve body and, in the same scale, the sheath of synthetic material to be inserted upon said pin with the aim to favour adhesion of a new cloth to the pin under examination for the variant of embodiments shown at Figures 21 and 22.

Description ofa preferred embodiment: With particular reference to said Figures; the valve placed outwards is constituted by the flanged tubular body 10 which provides for a flange 11 crossed by a suitable number of holes 12, four in the embodiment example which is in addition provided with a tubular body 13 projecting outwards and threaded outside. Tubular body 13, in coincidence with its free edge is equipped with at least one slot 14fitto house a seal 15 (O-ring for instance), as shown in Figure 2.

In addition, tubular flanged body 10, provides for an annular bead 16, the section of which decreases gradually towards its free end and is bent towards the axis of body 10, as shown in detail in Figure 9; said provision being on the inner face of the flange 11, namely on the face opposite to the face projecting from tubular body 13. The duty of annular bead 16 is to provide for a seal between the inside face of flange 11 and the patient's skin against which the flange in question shall rest; the inclination of the above mentioned bead permits to reach a seal which is the more efficient, the stronger the pressure inside the bead with respect to the pressure outside.

The wall of tubular body 13 is radially crossed by a passing threaded hole 17. The said hole is fit to house vent pin 20, or more precisely its threaded end part, As it is evident in Figure 15 and in greater detail in Figure 16 the threaded end of the vent pin 20 is crossed by a first axial passage 21 and by a second diametral passage 22; said second diametral passage 22 is preset at the root of the threaded segment of the vent pin so as to allow communication between the inner part of 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, coaxially and successively-divided by a bore 33 of greater diameter.

Bore 33 only affects a 1800 arc since it prolongs as a loophole through the wall of the valve body 30, by virtue of a case 34 which permits introduction and sliding of a gate shutter 40.

The cylindrical segment of greater diameter 32 of valve body 30 is threaded inside and fit to be screwed over tubular body 13 oftubularflanged body 10.

Outer cylindrical segment 31 oflesserdiameter than valve body 30 is provided on its edge oriented towards slot 33 and fit to house gate shutter 33 with an annular slot 35 fit to house a seal -(O-ring for instance) identified by number 36 in Figure 2.

It follows that when the valve body 30 is screwed on tubular segment 13 of tubular flanged bodyl Oi the gate shutter reaches a tight seal by virtue of two seals 15 and 36. However, it shall be noted that said seals can also be omitted in case the machining degree of shutter 40 and slot 33 housing it, is sufficiently sophisticated.

Finally, the shutter 40 is preferably provided with a short flange 41 fit to permit easy grasping and positioning. The remaining part consists of a flat plate providing for a primary semicircular area and a secondary area substantially rectangular in shape.

Proper sizing of parts 40, 10 and 30 shall allow shutter 40 to rest, by friction, in the prearranged position from time to time by virtue of flange 41, without requiring the application of remarkable forces for shutter extraction and insertion.

The greater diameter tubular or internal part-32 of the valve body 30 is equipped, behind case 34, with a notch (cavity) 37 in order to allow access of vent pipe 20 to the threaded hole 18 of tubular body 11 of flanged tubular body 10. The operation of valve 10-30-40-20 is easy to understand when the vent pipe 20 is screwed and when shutter 40 is pushed against the bottom of notch 33, the valve, so far considered as a simple intercepting element, is closed; by partially unscrewing vent pipe 20 the valve allows gas flow from inside to outside the valve; by consequence and with the aim to permit, through the hole 18 only the flow of gas and not of liquids, it is advisable to assemble body 30 with hole 18 turned upwards.The partial or total opening of shutter 40 will on the contrary allow for the flow of liquids as well as of solids. The parts hereinabove described represent only a preferred form of embodiment of the valve itself, meant as intercepting organ to be used, according to the invention, outside the patient's body. It is clear that pos#sible incidental variations are performable in the embodiment of the system 10-30-40-20, whilst the peculiar characteristics of the invention lies in the means used to allow fastening of the actual on-off valve to the patient's body, by virtue of an internal support flange 50.Saidinternal supportflange 50 consists of a flattened ring due to be fastened to the outside of the abdominal muscle-after having fixed the colon wall 61 by means of sutures to the peritoneum 60 and to the abdominal muscle and before having fixed the colon wall 61 to the skin 63. Proper positioning ofthe internal support disc is carried on by means of suture poi#nts to the abdominal muscle 62, by utilizing proper passages 51 distributed in circle on the wall of the internal support flange 50.

It follows that the mechanical valve claimed is substantially constituted by an internal part in the abdomen of the patient made ofthe support-internal flange 50 and of an external flange constituting the actual valve 10-20-30-40.

In order to provide fastening of thetwo parts, either inside or outside the claimed valve, different solutions can be adopted. According to th#e ambodiment of internal support flange 50 shown in the Figure, a proper number of connecting pins 70 project through layers 63 and 64 fastened steadily to internal support flange 50 and provided on the outer side with connecting means with blocking components, such as screws 71, which screw in threaded axial hole 72, prearranged in the outside part of connecting pins 70.

It is clear that said pins not only cross layers 63 and 64 but also the thickness of flange 11 of tubular flanged body 10 by virtue of corresponding passing holes 12.

The solution shown in the Figure that in addition to screw 71 provides for connecting pins bored and threaded in their outer end, permits to grade the tightening effort that pushing through flanges 11 and 50 presses the adipose layer 64 and the skin 63 of the patient, also in relation to incidental thickness changes which may take place in said layers.

The steady connection of pins 70 to the internal support flange can be accomplished as shown in Figure 4,6 and 7; the flattened ring 50 provides elongate recesses 54 into which the pins elongate heads 73 of complementary shape are inserted, to prevent rotation of the pins 70; in addition, each pin 70 has a groove immediately adjacent its head 73, in which engages a V-section ring formed by the inner wall of the respective hole 55, the pin 70 being of slightly larger diameter than the ring, thereby providing final snap engagement of the pin 70 in the hole 55 in such a way that the pin 70 cannot be removed.

A simpler option,the construction of which is however quite sophisticated, provides f6r#con nect- ing pins 70 to be built-in with flange 50. It is Obvious that pins 70 shall cross the layers 63 and 64. Possible variant of the connecting system between internal support flange 50 and flange 11 offlangedtubular body 10 can be constituted by a couple of magnetic rings cast in the thickness of flanges 11 and 50 and fit to set sufficiently high tightening force.

With particular reference to the variant of embodiment shown in Figure 19 and 20, the tubular flanged body 110 is also in this case provided with a cylindrical part 113, a flange 11 and a seal 116.

Furthermore and according to the variant shown, the tubular wall 113 provides a pad 80 housing a threaded long pitch hole 84, wherein a threaded pin 85 projects in the lower partfrom a small cylinder 86 allowing easy grasping by the patient, as well as for consistent raising (e.g. one millimetre), by effecting a comparatively limited rotation ( e.g. 180'). The lower end of small cylinder 86 is tapered and is housed into a corresponding tapering seat 83; therefore when pin 86 is thoroughly tight, sealing takes place.

A small channel 82 flows into the tapered seat, connected with internal tubular flanged body 110 through an open-cell porous body acting as a filter.

Said filter can be welded on the flanged tubular body 110 and therefore it can be manufactured in a different material.

It is clear that on the outside orifice of the actual valve a removable resistant and thin bag can be properly placed.

With particular reference to Figures 21 to 24, the following numbers 60,61,62,63, and 64 identify respectively the colon, the peritoneum, the abdominal muscle, the outside adipose layer and the cutis.

Internal support flange 50 is inserted between abdominal muscle 62 and adipose layer 64.

Pins 70 previously fastened to internal support flange 50 cross layers 64 and 63 and protrude from the cutis so that they can be used to couple valve body 210 through proper holes 212 prearranged on flange 211 of valve body 210. According to the embodiment shown in Figure, valve body 210 provides for a tubular part 213 threaded outside on which a hollow plug 214 can be screwed.

In order to ease the removal of intestinal residues, a thin, flexible, waterproof multifolded bag is inserted inside tubular body 213 providing for a slot 215 to house a reinforcing ring on the edge of the bag, and placed over the external threading.

According to said embodiment, no gas blowoff is provided for independently of the removal of intestinal residues; however the valve according to the invention is extremely simple, both as far as its construction and its operation are concerned.

According to the embodiment shown in Figure 1, the seal of lip 216 is improved 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 threading.

The above mentioned embodiment shown in the Figure provides for the pins 70 to be threaded outside in order that their end projecting from a flange 210 can house a socket nut 271.

In order to allow adhesion of the tissue around pin 70, as shown in Figure 4, the latter is lined, before operation, with a 70' wire gauze polyethilene terephthalate pipe which had revealed its fitness as a support in the process of cell formation.

In the embodiment shown in Figure 2, the valve body 310 has substantially remained unchanged with the exception of a shorter tub ularthreaded body 311.

In this case no bag tightly fastened on the edge of the tubular body is provided, whilst seal is ensured by O-ring 312 housed inside a corresponding slot prearranged on the internal side of the hollow plug.

The absence of the bag utilized in Figure 1 permits however mounting a relief valve 315 composed of a push button 316 fastened on a pin 317 crossing the hollow plug; at the opposite end a head shutter 318 is mounted.

A spring keeps a head shutter 318 tight with its seat and the gas blowoff takes place only when the push button is purposely pushed.

A seal 320 is inserted between the patient's skin and the flange 311 of the valve body 310; this ensures a fit seal as an alternative to the elastic lip 216 associated to O-ring 217 shown in Figure 1.

Claims

1. A mechanical valve for closing a cutaneous stoma to give the patient the faculty of intestinal transit at required time intervals, characterized in that it comprises an internal support element of the actual valve displaced outside the patient's body; wherein said internal support element is crossed by the e.g. colon which is sutured around the edge of the hole of the abdominal wall and is fastened to the outer face of the muscular layers by means of sutures.

2. A mechanical valve, according to the previous claim characterized in that said internal support element of the actual valve, externally placed, is made of a flatttened ring with rounded edges and provided with holes disposed in a circle to allow the suture points to reach the muscle layers.

3. A mechanical valve, according to the previous claim, characterized in that, a proper number of coupling pins regularly disposed in a circle are provided and project from the patient's body passing through the adipose tissue and the skin of the abdominal wall so that their projecting ends can be used to fix the actual valve itself placed outside.

4. A mechanical valve according to the previous claim, characterized in that the actual valve placed out of the patient's body is provided with a flange, fit to superimpose, with the interposition of the adipose tissue thickness and of the skin of the abdominal wall to the internal support flange and fit to cooperate with the coupling pins that depart from the latter projecting out of the abdominal wall.

5. A mechanical valve according to the previous claim, characterized in that said coupling pins pass over through the corresponding hole to the flange of the actual valve placed outside; corresponding number of screws fit to be screwed in the holes made at the ends of the connecting pins are provided for to attain the required tightening effort between said two flanges.

6. A mechanical valve, according to claim 4, characterized in that the flange of the actual valve itself is provided on its side towards the patient's skin with, at least, one seal.

7. A mechanical valve, according to claim 6, characterized in that said seals are steadily fastened or welded in the internal face of the mentioned flange in which their radial section is tapered from bottom to top and converges towards the valve axis so as to form a seal, the efficiency of which grows when the internal pressure rises.

8. A mechanical valve, according to the previous claims, characterized in that the valve itself placed outside involves a flanged tubular body in which said cylindricalpart can house a valve body crossed out by a transverse slit fit to allow for the traversing of a gate shutter.

9. A mechanical valve, according to claim 8 in which the cylindrical part of the tubular flanged body provides at its root, viz. in proximity of its flange for a hole possibly preceded by a filter fit to house a vent pin.

10. A mechanicalvalve, according to claim 9, characterized in that said filter is constituted by an insert of open-cell porous material preferably in polyurethane or similar plastic materials.

11. A mechanical valve, according to claim 1, characterized in that it provides for an internal support flange with pins projecting outside, to be inserted and fastened into the thickness ofthe tissue, in which a valve body is fastened outside saidpinsto the internal support flange, in which said valve body provides for annular flange and a tubular body threaded outside fit to house a hollow plug.

12. A mechanical valve, according to claim 11, characterized in that an annular slot is provided for on the edge of the tubular body of the valve body fit to house the elastic reinforced rim of a flexible foldable bag to be inserted into the tubular body of the valve body before closing the said plug.

13. A mechanical valve, according to claim 11, characterized in thatthe bottom of the said hollow plug provides for an annular slot fit to house an O-ring fit to be pushed against the annular end of the tubular body of the valve body.

14. A mechanical valve, according to claim 11 characterized in thatthe annular flange of the valve body provides for a seal lip which is kept retracted in the position of maximum efficiency by means of an O-ring.

15. A mechanical valve, according to claim 11 characterized in that the annular flange of the valve body provides for an area equipped with annular teeth resting against a proper seal of same shape interposed between the flange and the epidermis of the patient.

16, A mechanical valve, according to claim 11 characterized in that the pins protruding from the internal support flange are threaded outside and fit to house socket nuts.

17. A mechanical valve, according to claim 16 characte#rized in that said pins are lined with a theraphthalate polyethilene hose, in order to ease fastening of the fresh tissues on the surface of the said pins.

18. A mechanical valve for closing a cutaneous stoma ofthe gastroenteric duct to enable the stoma to be opened when desired, the valve comprising a valve body for securing to the outside of the patent's body and an internal support element arranged to be positioned within the patient's body with a portion of the gastroenteric duct passing through the support element, the support element also being arranged to be sutured to the outer face of the muscular layers of the patient's body.

19. A mechanical valve for closing a cutaneous stoma of the gastroenteric duct to enable the stoma to be opened when desired, substantially as herein described with reference to, and as shown in, Figures 1 to 18 or Figures 19 and 20, or Figure 21 or Figure 22 or Figures 23 and 24 of the accompanying drawings.