A PROCESS AND A DEVICE FOR MAKING A HOLE

Abstract: A process and a device for making a hole in a sticking plaster body plate (1) made of plastic material, which can be or is connected to a receptacle at a surgically-formed stoma and which has a layer of adhesive (2) covered with a removable protective layer (3). The invention enables a hole to be made quickly and effectively with simple means. The hole-making process involves a hole-making tool (8), which has a punch element part (14, 15) of the required width projecting out from an abutment surface (13) on the tool and having a cutting edge surface (14) which slopes inwardly away from the said abutment surface (13) being used to press the punch element (12; 12') against the plate (1) so that the cutting edge (14) cuts through the plate (1) in the direction of the protective layer (3), the punching depth being determined by the co-action between the abutment surface (13) and the upper surface (1B) of the plate it is resting upon, whereby a hole (25) adapted to the stoma patient and having a hole edge (22A) sloping towards the side (1A) with the adhesive on it, is made through the plate (1).

Description: A Process and a Device for Making a. Hole The present invention relates to a process formaking a hole in a body plate made of plastic material which can be or is connected to a receptacle at a surgically-formed stoma and which has a layer of adhesive covered by a re- 5 movable protective layer. The invention also relates to a device for carrying out the said process. The known method of making a hole through a body plate of the above-mentioned kind is to try to cut through the material of the plate with scissors, for example, or some other suitable tool, to form a hole of the required size to . fit the stoma aperture in the person concerned. However, it is impossible to produce with scissors an exactly similar hole every time through the stoma skin- 15 protecting plate used, which is changed several times a week, and as a result complications can arise such as irritation of the skin and stoma, chafing with the risk of bleeding, and also an increased risk of leakage. It would therefore be ideal if a hole with.the exact hole 0 dimensions could be produced every time, to eliminate the said disadvantages. When making a hole with the aid of scissors, which are a means which patients are not allowed to take with them when travelling by air, a hole is produced with its 5 inner surfaces substantially at 90° to the plate, which means there is a risk of producing a chafing effect round the edges of the hole, as described above. It would there ¬ fore be desirable to produce a hole through the plate whereof the edges of the inner surface do not entail the 0 risk of the said damage. The upper surface of stoma plates has a protective plastic film and contact between this film and the skin should be avoided so as not to cause the patient problems, and it is therefore also an object to try to avoid the said plastic film co ing into OMPI contact with the skin from the start when applying the plate to the body. It is also important to produce a hole in such plates with edges which do not form a breed¬ ing ground for bacteria after the said hole has beenmade, and that the protective covering is not broken through when making the hole, with a view to protecting the edges from dirt, etc. and retaining a good level of adhesion over the whole plate. The main object of the present invention is primarily to provide a process-of the above-mentioned kind which solves the problems described above and which enables a hole with the desired dimensions to be made quickly and simply through the plate, and to produce hole edgeswhich do not entail the risk of a chafing effect on the stoma, etc. in the patient. The said objects are accomplished by means of apro¬ cess according to the present invention which is essent¬ ially characterised in that a hole-making tool, whichhas a punch element part of the required width projecting out from a tool abutment surface and having a cutting edge surface which slopes inwardly away from the said abut¬ ment surface, is used to press the punch element against the plate so that the cutting edge cuts through theplate in the direction of the protective layer, the punching depth being determined by the co-action between the abut¬ ment surface and the upper surface of the plate it is resting upon, whereby a hole adapted to the stoma patient and having a hole edge sloping towards the side with the adhesive is made through the plate. A. further object of the present invention is to pro ¬ vide a device which enables the said process to be carried out without the necessity of resorting to the whole tool set-up for a- hole-making tool which requires grinding and maintenance and which is susceptible to cutting-edge dam- age, β *c- The said further object is achieved with a device which is essentially characterised in that a hole-making tool has a punch element part which projects from a tool abutment surface, and that the punch element part has a cutting edge surface which slopes inwardly away from the said abutment surface and the penetration depth into the plate of which is limited by the co-action between the abutment surface and the upper surface of the plate. The invention is described below by way of a pre¬ ferred embodiment example, with reference to the accom- panying drawings, on which -Figure 1 is an exploded perspective view of a.hole- making tool constructed according to the invention, with a stoma receptacle plate, Figure 2.is a partially sectioned view of the tool and the plate, Figure 3 shows the tool viewed obliquely looking onto its face, Figure is a schematic cross-section through part of the punching tool and the plate during the hole-making process, Figure 5 is a schematic cross-section through the punching tool and the plate with the hole-punching com¬ pleted, Figure 6 shows the holder viewed obliquely from the front, Figure shows an interchangeable punch element, viewed obliquely from above, and Figure 8 again shows an interchangeable punch element provided with a central pin, viewed from below. -A plate made of plastic material and already known per se, which is designated with the numeral 1 on the drawings and which is coated on its rear face 1A with an adhesive substance 2 of a suitable kind which.is normally covered by a protective layer 3 made of paper, for example, is designed to be attached to the body of the person whom it is intended should carry a stoma receptacle of a suit- able kind. The receptacle is preferably attached to the plate 1 by being snapped via a connecting part into a projection on an annular flange 5 rigidly connected to the upper face of the plate. The said protective layer3 and the plate 1 expediently have a hole 6 through them at the centre line 7 of the flange, but the invention is also suitable for use with stoma receptacle fixingplates which do not have such holes 6 and flanges 5. A device 8 which is suitable for use when making a hole through a fixing plate 1 as described above consists of a hand-held punch holder 9 which is provided at its upper end 9A with a handle part 10 which can be held com¬ fortably and which is formed in the preferred embodiment example of a rod which can be detached by twisting in the direction of the arrow 11, and the ends 10A and 10B of which have rounded sections with a view to enabling them to be used as applicators for spreading ointments, etc. on the plate 1, and also to serve as additional appli¬ cation and fixing means by using them to press the plate on inside the annular flange 5. Since the space here is rather confined and is often surrounded by sticky fixing substances it is very important to be able to fix the plate in place on the body to prevent leakage. Thehandle part 10 should also be made of a material which is suit- able for being sterilised by boiling in water, or heated in some other way to facilitate the attaching of the plate 1 by massaging over the upper face of the platewith the end 10A, 10B of the handle, especially round the outer edges. A punch element 12 which is preferably detachable from the said punch holder 9 has located at its front end 12A a cutting edge surface 14- which, slopes inwardly away from an annular abutment surface 13, the function ofwhich will be described later. The inside of the said punch- ing surface 4- preferably has a smooth surface 15, which preferably extends at right-angles to the said abutment surface 13- The width of the said cutting edge surface 14 corres¬ ponds to the width of the stoma patient's intestinal con¬ nection aperture, etc., and in order to make it possible to produce holes in the plate 1 which corresponds to in¬ testinal apertures of varying widths the punch element 12 will preferably belong to a punch set made up of a plur¬ ality of punches, for example three, the width at the cutting edge surface of which varies from punch to punch between a smallest and a largest value. The punch ele¬ ments 12 which appertain to the said set can be markedin an appropriate way, for example with colour markings, so that the user will be able to recognise the width of the punch easily, the various colour markings indicating the flange with which the punch matches, and the width ofthe cutting edge may also be marked on the punch element 12 by impressing it clearly on it, for example. As shown on the drawings in Figure 7*» £ example, the rear end 12B of the said punch element 12 has a con- necting part 16 expediently in the form of a projecting shaft 16 which in the embodiment example shown has a non- circular cross-section profile similar to a rectangle with rounded corners 1 . A smooth transition 18 with curved shaping in the form of a concave moulding is provided at the transition between the shaft 16 and the punch element 12. The front end 9B of the punch holder 9 has a cut-out 19 adapted to receive a punch connecting part 16. The circumferential edge 20 of the said cut-out 19 is rounded off, and is substantially congruent with the transition 18 between the shaft 16 and the punch element with a view to achieving effective fixing of the punch element 12 in the punch holder 9. It is also possible to provide a projecting connect- i π S part on the punch holder 9 an a complementary cut-out for receiving the said connecting part on the punch OMPI WIPO , element 12, or a combination thereof, with a projecting connecting part as well as a cut-out on both the punch element 12 and the punch holder 9. The punching tool described above for making a hole through a stoma receptacle fixing plate 1 of the type which is shown on the drawings and which is provided with an annular connecting flange 5 functions as follows : A punch element 12 with the required punching width is connected to the punch holder 9 " by bringing them towards each other as shown by the arrows 21 in Figure 1. After this, the punch element 12 is moved, centred by co-action between its outer circumferential part 12C and the inner part of the annular flange 5 on the plate 1, towards the upper surface 1B of the plate which consists of a pro - tective covering 22 such as a plastic film which protects the soft plastic material 23 lying beneath it which has the properties both of being kind to the skin and also of preventing bacteria cultures and the like from being developed readily on it. When the tool 8 is rotated in "fclie direction of the arrows 24 the cutting edge surface 4 which slopes inwardly away from the annular abutment surface 13 of the punch element towards the central axis 7 of the hole which it is desired to make through the plate 1, cuts through the outer covering 22 and the plate 1 as shown on the drawing in Figure 4, so that in the vic¬ inity of the said cutting edge surface 14 the former is bent round in a curve towards the hole 25 made throughthe plate 1. The said bent round outer covering part 22A acts as a protection for the plastic plate material 23 lying beneath it at the upper surface of the plate round the hole 25, and prevents soiling of the circumferential edge of the hole. The depth of the hole punched is limitedby the penetration capacity into the plate 1 of the cutting edge 14, 15, and by adapting the height of.the effective cutting edge to the thickness of the plate, with contact between the abutment surface 13 and the upper surface 1B O PI y, WIPO of the plate the punching depth can be set so that the punch cuts through the plate 1 up to the vicinity of the lower removable protective layer 3 , as shown in Figure 5. If the plate 1 does not have a hole 6 through it initially, a punch element 12' such as that shown in Fig¬ ure 8 can be used; this has a central pin 26 with a point. For centring the punch in the desired hole-making position on a plate which has no flange, a separate tem¬ plate with a hole outline may be placed on top of the plate to guide the circumferential part 12C of the punch by co-action therewith. When attaching a fixing plate 1 with a hole made in it, the protective layer 3 which protects the layer of adhesive 2 beneath it is removed, after which the plate is attached to the body so that the hole 25 which hasbeen made comes into position directly over the intestinal aperture, etc. A suitable material for the tool is cellulose plastic, or some other appropriate material which is suitable for the measures described above and which allows a cutting edge 14, 15 to be produced which retains its sharpness without needing to be ground, etc. The invention is not limited to the embodiment ex¬ ample described above, but may be modified within the framework of the following Patent Claims without exceed ¬ ing the basic concept of the invention.

Claims: P a t e n t C l a i m s 1. A process for making a hole in a body plate (1) made of plastic material which can be or is connectedto a receptacle at a surgically-formed stoma, and whichhas a layer of adhesive (2) covered by a removable protective layer (3), characterised in that a hole-making tool (8), which has a punch element part (14, 15) of the required width projecting out from a tool abutment surface (13) and having a cutting edge surface (14) which slopes in¬ wardly away from the said abutment surface (13), isused to press the punch element (12; 12 1 ) against the plate (1) so that the cutting edge (14) cuts through the plate (1) in the direction of the protective layer (3), the punching depth being determined by the co-action between the abutment surface (13) and the upper surface (1B) of the plate it is resting upon, whereby a hole (25) adapted to the stoma patient and having a hole edge (22A) sloping towards the side (1A) with the adhesive, is made through the plate (1). 2. A process according to Patent Claim 1, character- ised in that a hand-held punch holder (9) with a prefer- ably interchangeable punch element (12; 12*) is used. 3. A process according to either of the preceding Patent Claims, characterised in that the circumferential part (12C) of the punch is guided into position on the plate (1) by means of a centring element (5) before the hole is punched. 4. A process according to Patent Claim 3, character¬ ised in that an annular flange (5) which is rigidly con¬ nected to the plate (1), or a separate hole-centring tem- plate which can be placed on the upper surface (1B) of the plate, is used. _O PI 5. A device according to any of the above-mentioned Patent Claims for making a hole in a body plate (1) made of plastic material which can be or is connected to a stoma receptacle and which has a layer of adhesive (2) covered by a removable protective layer (3), character¬ ised in that a hole-making tool (8) has a punch element part (14, 15) which projects out from a tool abutment surface (13), and that the punch element (12; 12') has a cutting edge surface (14) which slopes away from the said abutment surface (13), and the penetration depth into the plate (1) of which is limited by the co-action between the abutment surface and the upper surface (1B) of the plate. 6. A device according to Patent Claim 5, character- ised in that the tool (8) consists of a hand-held rotat- able punch holder (9) with a punch element (12; 12*) which is preferably interchangeably connected to it. 7. A device according to either of Patent Claims 5-6, characterised in that the punch element (12; 12') consists of an annular cutting edge (14, 1 ) projecting out from a flat external annular abutment surface (13). 8. A device according to any of the above Patent Claims 5-7, characterised in that the circumferential part of the front end (12A) of the tool is circular. 9. A device according to any of the preceding Patent Claims, characterised in that the punch (12; 12') has a connecting part (16) disposed at its rear end (12B) and designed.to be connected to the hand-held holder (9) of the tool, the said punch element (12; 12') preferably appertaining to a set of punches with different punch hole widths for punching holes (25) of a required width through a plate (1). 10. A device according to any of the above Patent Claims 5-9, characterised in that the punch element (12') has a central pin (26) with a point provided on its front face. OMPI

Inventors: SAMUELSSON BENGT, WALLSTROEM HAOKAN, SAMUELSSON, BENGT, WALLSTROEM, HAOKAN
Applicants: SAMUELSSON & WALLSTROEM PROD, SAMUELSSON & WALLSTROEM PRODUCTION AB
Application year: 1984
Main classification: A61F5
IPC codes: A61F5, B26F1