Source: https://patents.google.com/patent/EP0098718A1/en
Timestamp: 2018-09-24 06:59:03
Document Index: 241456711

Matched Legal Cases: ['art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 32', 'art 20', 'art 32', 'arts 20', 'art 32', 'art 32', 'arts 20', 'art 32', 'art 32', 'arts 20', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 32', 'art 20', 'art 32', 'art 20', 'art 20', 'art 52', 'art 50', 'arts 20', 'art 20', 'arts 20', 'art 32', 'art 32', 'art 20', 'art-32', 'art 92', 'art.\n6', 'art.\n7', 'art.\n9', 'art.\n38', 'art.\n40', 'art.\n42']

EP0098718A1 - Improved ostomy device - Google Patents
Improved ostomy device Download PDF
EP0098718A1
EP0098718A1 EP19830303660 EP83303660A EP0098718A1 EP 0098718 A1 EP0098718 A1 EP 0098718A1 EP 19830303660 EP19830303660 EP 19830303660 EP 83303660 A EP83303660 A EP 83303660A EP 0098718 A1 EP0098718 A1 EP 0098718A1
EP19830303660
EP0098718B1 (en )
First and second annular interengaging parts releasably connect the pouch (10) and adhesive-backed label (26). A member (36) is provided for mounting one of the parts to the label, at a normal position proximate the surface of the label. The member includes a ring-shaped section (40), spaced from the part, which is adapted to be affixed to the surface of the label, and an expandable section, preferably including one or more accordion-like folds (46), interposed between the ring-shaped section and the part, to permit the part to be displaced relative to its normal position. The member (36) will return to its normal position unless a detachable element is inserted beneath the member to retain the part in the displaced position. The other interengaging part (20) may be provided with a flange-like portion (50) situated to cover the expandabie section, when the parts interengage, to protect the expandable section from waste material. Auxiliary interengaging parts may be provided to prevent accidental detachment and aid in supporting the pouch.
The present invention relates to ostomy devices of the type including releaseable interengaging parts adapted to permit detachment of the pouch from the adhesive-backed label and, more particularly, to the structure of the means utilized to mount one of the parts to the label, which comprises expandable means for facilitating displacement of the part relative to the label surface.
Over the years, significant advances have been made in the materials employed to construct the labels, particularly in the composition of the base and adhesive coating, such that the labels have become increasingly flexible and porous, permitting the labels, to be comfortably worn for extended periods of time. Recent improvements have extended the period during which the labels can be comfortably worn to be longer than normally required for the pouch to fill to capacity with waste material. However, it is still necessary, particularly with new users, to frequently remove the label from the skin to provide access to the skin surrounding the stoma. Removal of the label permits the user to observe and check the condition of the skin surrounding the stoma and, if necessary, to treat same. Thus, in spite of the improvements in label material, frequent removal of the one-piece type device, due to cleaning of the pouch and checking or treatment of the skin surrounding the stoma, is still normally required.
On the other hand, frequent removal of the adhesive-backed label from the skin is to be avoided. The skin surrounding the stoma is often extremely sensitive and may comprise a healing incision or scar tissue. Although the adhesives utilized in the label are formulated to reduce, as much as possible, irritation of the skin when the label is removed, it is preferable to limit the number of times the label must be removed from the skin as much as possible. ,
The two-part structure requires a means for releasably connecting the pouch and the label. One particularly successful device takes the form of a pair of annular or ring-like rigid plastic parts--one in the form of a flange, and the other in the form of a groove. The parts are designed to frictionally engage to secure the pouch to the label and, when necessary, to disengage to permit,removal of the pouch from the label. The parts are mounted to the pouch and label, respectively. The pouch and label can be connected by simply aligning the parts and pressing same together to cause frictional engagement.
When the label is mounted to the skin, the parts are engaged by applying a force on the exterior portion of the pouch over the parts in the direction of the label. This force is of a significant magnitude and is absorbed by the skin beneath the label. However, since the skin under the label may be sensitive, particularly in the time period following the surgical procedure creating the stoma, applying sufficient force to the skin to cause engagement of the parts is often painful and may even be destructive. It is therefore desirable to develop a system which would permit engagement of the parts without the application of. significant force on the skin.
Accordingly, the rigid method of mounting the part to the surface of the label, namely bonding the bottom surface of the part directly to the surface of the label, had to - be discarded. Such a structure would not provide the necessary flexibility to permit the fingers to be placed behind the part, when the pouch and label were being connected.
Another drawback of conventional detachable pouches, in general, relates to.the possibility of the pouch accidentally detaching as it is worn. This is a difficult result to avoid since the amount of force necessary to detach the interengaging parts is determined by the structure thereof and is a function of the amount of force necessary to frictionally engage the parts, which, in turn, is limited, as indicated above, by the amount of force which can be acceptably applied to the skin under the label. Consequently, it is not feasible to alter the structure of the interengaging parts to provide additional security against accidental detachment, unless some complex and costly release mechanism is incorporated into the structure.
The label is provided with an aperture therein. The second part mounting means is provided with a central aperture, situated to align with the label aperture. The section of the second part mounting means affixed to the - label preferably su;rounds the aligned aperture.
The second part mounting means preferably comprises a second section extending between and joining the expandable means and the part. The second section is preferably sealed to the part along the edge of the part between the inside surface and bottom surface thereof. In this manner, space between the part and the second section is eliminated and accumulation of waste material between the part and the mounting means is prevented.
The second part mounting means preferably comprises a section adapted to be affixed to the surface of the label. The portion of the second part mounting means prox- . imate to the second part and protected by the cover means preferably comprises the portion of the second part mounting means between the section affixed to the surface of the label and the second part.
In accordance, with another aspect of the present invention, an ostomy device is provided comprising a pouch, an adhesive-backed label, and means for releasably connecting the pouch and the label. The connecting means are affixed to the label by a member including expandable means. Means are provided for retaining the expandable means in the expanded condition.
Fig. 12 is a cross-sectional view of the embodiment illustrated in Fig. 10, in the assembled condition;
Fig. 14 is a cross-sectional view of the.p.resent invention illustrating a first preferred embodiment of the expansion retaining means;
Fig. 15 is a horizontal section taken along line 15-15 of Fig. 14;
- Fig. 1 illustrates a commercially available ostomy device with a detachable pouch. The pouch, generally designated 10, comprises a first or outer wall 12 and a second or inner wall 14, both composed of a thin, moisture- impermeable, odor-proof, thermo-plastic film or laminate. The interior surfaces of walls 12 and 14 are sealed along the periphery 16 thereof, so as to form the contour of the pouch. Wall 14 is provided with a stoma receiving aperture 18.
Surrounding aperture 18 is an annular plastic part 20, preferably in the form of a ring-shaped groove, which forms one of the interconnecting parts. The rear surface of part 20 is affixed to the exterior surface of wall 14 in any appropriate manner, such as welding or by a layer of adhesive or the like. Extending outwardly from the side of part 20, in opposite directions, are a pair of belt- receiving elements 22 which can be utilized to connect part 20 and, thus, pouch 10 to a belt designed to extend around the body. Also extending from the side of part 20, near the top thereof, is a tab 24 designed to facilitate grasping of part 20.
To the front surface 29 of base 28 is mounted the second interengaging part 32, which preferably takes the form of an annular orring-like protrusion 31 and an outwardly extending flange 33. Protrusion 31 is fashioned to frictionally engage groove-like part 20. Part 32 is mounted on label 26 at a point surrounding an aperture 34 in the label. Aperture 34 in label 26 is designated to align with aperture 18 in pouch 10 when parts 20 and 32 are frictionally engaged.
As discussed previously, part 32 could be affixed directly to surface 29 of base 28. However, this does not permit the user to insert his fingers between part 32
and label 26, so as to absorb the force applied to interengage parts 20 and 32.
Consequently, the mounting method illustrated in Fig. 2 has been proposed. Part 32 is mounted to base 28 of label 26 through the use of a circular-shaped thin film member 35. Film 35 is provided with an aperture 38, at the central portion thereof. Aperture 38 aligns with aperture 34 in label 26. Film 36 is affixed to base 28 by means of a ring-shaped weld, laminate, or adhesive section 40 surrounding, but spaced a short distance from, aperture 38. Film 35 extends outwardly from section 40 and is affixed to the exterior edge of the bottom surface of flange 33.
However, as indicated above, the structure disclosed in Fig. 2 has two major drawbacks. When the fingers are inserted behind .part 32, as shown in Fig. 2, substantial stress is concentrated at points 42 near the exterior of section 40, adjacent the position of the fingers. These stress points 42 tend to disrupt the integrity of section 40 and may cause film member 35 to detach from base 28.
Both of these disadvantages associated with the mounting structure, illustrated in Fig. 2, are eliminated by the structure of the present invention. Figs. 3,*4, and 5 illustrate the structure and function of the first preferred embodiment of the present invention, which is designed to overcome the defects noted above. All parts of the device of the present invention illustrated in Figs. 3, 4, and 5 are identical to those illustrated in Figs. 1 and 2, with the exceptions noted below. For this reason, a detailed description of the previously described parts and the function of same is omitted.
Fig. 3 illustrates the structure of the label of the present invention. Figs. 4 and 5 illustrate the manner in which the new label structure facilitates engagement of parts 20 and 32 through the use of the expandable means which forms a portion of member 36. Figs. 4 and 5 also illustrate the cover means associated with. the part mounted on the pouch and the manner in which the cover means protects the expandable means when the parts are engaged. The expandable means preferably comprises one or more accordion-like folds 46 (three are illustrated in Figs. 3, 4, and 5) formed in member 36 at a location between section 40 and the portion of member 36 to which part 32 is affixed. Accordion-like folds 46 facilitate the displacement of part 32 relative to surface 89 by permitting member 36 to expand when the fingers are inserted between the part and the label, and, as a result, eliminate stress on points along section 40 such that the integrity of section 40 is not likely to be disrupted in normal usage.
It should be noted that, in the preferred embodiment of applicant's invention, member 36 is affixed to the bottom surface of flange 33 at a point spaced from accordion-like folds 46, through the use of an adhesive layer or the like. The upper surface of member 36 is adjacent the interior edge of part 32. This manner of affixation eliminates pocket 44 present in the conventional mounting structure -between part 32 and member 36. Thus, with the structure of the present invention, it is not possible for any waste material to collect under part 32.
It should also be appreciated that flange 33, extending outwardly of protrusion 31, can be eliminated, if desired. In that case, member 36 would be affixed to the rear surface of protrusion 31, adjacent to the interior side thereof. This structure also eliminates the possibility of waste build-up under part 32.
Fig. 6 illustrates the second preferred embodiment of mounting means of the present invention. This embodiment is identical in all respects to the embodiment shown in Fig. 4, except that accordion-like folds 46, instead of normally extending in a direction substantially parallel to surface 89, normally extend in a direction substantially perpendicular to surface 89. In this case, the last or uppermost fold 51 is directly affixed to the bottom of protrusion 31 of part 32, such that no waste material can collect under part 32. Here again, flange 33 may be eliminated, if desired.
It will now be appreciated that accordion-like folds 46 may expand in a direction either parallel to or perpendicular to surface 89. The only limitation on the number and structure of the accordion-like folds is that member 36 must have sufficient strength to prevent substantial expansion during normal use of the device. That is, member 36 must have sufficient strength to withstand substantial expansion- caused by the weight of the pouch, and thus maintain part 32 proximate surface 89, even when the pouch is filled to capacity.
In the first embodiment, with part 32 mounted to label 86, it is not possible to injection mold part 32 and mounting member 36 In a single operation. This is because in order to properly form the lip 87, which extends. inwardly from flange 31 and enhances the frictional engagement with the groove or channel of part 20, a mold part must be provided behind the lip as the lip is formed. Accordingly, part 32 and member 36 cannot be formed in a single operation, but must be formed separately and thereafter joined together. However, part 20 and member 36 can be formed integrally, in a single injection molding operation, providing a significant manufacturing advantage.
The second structural difference relates to the addition of a bead 90 of material provided in member 36 at the interior edge of section 40 which surrounds the portion of base 88 where the stoma receiving aperture is situated. Base 88 is normally supplied by the manufacturer with a very small central aperture which is enlarged to the appropriate size before positioning the label portion around the stoma. If the aperture in base 88 is enlarged all the way to the interior edge of section 40 of member 36, the exposed edge of section 40 may be sharp enough to cut the side of the stoma as the device is worn. This problem is eliminated by creating a bead 90 of material, at the interior edge of section 40 of member 36. Because of the rounded structure of bead 90, the possibility of a sharp edge resulting from enlargement of the central,aperture is eliminated. Moreover, bead 90 provides a convenient visual means of determining the maximum size to which the stoma receiving aperture may be enlarged.
As illustrated in Fig. 8, the auxiliary interengaging parts comprise a pair of aligned tabs 50, 52 extending from the top of pouch primary interengaging part 20 and label 86, respectively. Secondary interengaging part 52 is provided with a protrusion 54 extending from one surface thereof. Protrusion 54 is preferably . provided with an enlarged tip 53. The other part 50 is provided with an aperture 56 designed to frictionally receive protrusion 54 therein. Before or after the primary interengaging parts 20 and 32 are frictionally engaged, the user places her fingers on either side of the aligned tab pair 50, 52 and forces the protrusion 54 into the aperture 56, such that enlarged tip 53 is situated adjacent the opposite surface of tab 50, so as to releasably connect the tabs. When the pouch is removed from the label, the process is reversed, with protrusion 54 being pushed out from the aperture 56 to release the tabs.
Whichever version of the secondary interengaging parts is utilized, it is preferable that the tabs extend upwardly from part 20 and label 86 at the tops thereof. In this position, the secondary interengaging parts will retain the pouch on the label, even if parts 20 and 32 become disconnected.
Figs. 10, 11, and 12 illustrate a modification of the present invention wherein the expandable means includes only a single accordion-like fold 46.. This configuration has several advantages over the multi-fold structure illustrated in Figs. 3 through 6, in that the single fold permits a larger stoma receiving aperture 34 and tends to expand more easily during assembly with the pouch. Moreover,.the device is easier to clean with only a single fold 46, as compared to the multi-fold version.
Another advantage of the single fold embodiment is illustrated in Fig. 12. Once the pouch piece is connected to the label piece, and the single fold 46 is in the non-expanded condition, the interior vertical surface of the fold acts as a barrier to prevent waste material from lodging between fold surface facing part 32 and the surface of part 32. Thus, no element 48 on part 20 is required to prevent lodging of waste material between the fold and part-32.
Element 90 can take various forms and may be detachable or simply pivotably connected to the label, by an articulated or flexible joint, in which case, it can be pivoted to a remote position when not in use. Moreover, element 90 may have a solid cross-section and be in the form of a detachable "0"-ring, as illustrated in Figs. 14 and 15, a detachable "0"-ring of hollow cross-section, as illustrated in.Fig. 16 as 90', or be a detachable ring-like member with an upstanding part 92 and an enlarged base 94, as illustrated in Fig. 17.
It will now be appreciated that the present invention relates to an ostomy device with a label and a detachable pouch wherein the structure employed to mount the interengageable part to the label increases the flexibility - of the label and facilitates displacement of the part relative to the surface of the label without creating undue stress on the section of the mounting member affixed to the surface of the label. In addition, the pocket or gap between the mounting member and the interengaging part is eliminated such that the accumulation of waste material beneath the interengaging part is prevented.
Through the use of expansion, retaining means, the expansion of the accordion-like fold can be maintained in order to keep the pouch at a location remote from the stoma. Moreover, for wounds which require an unobstructed elongated area, the interengaging parts may be made oval instead of round.
1. An ostomy device comprising a pouch, an adhesive-backed label and means for releaseably connecting said pouch and label, said connecting means comprising first and second interengaging parts, means for mounting said first part to said pouch and means for mounting said second part to said label, at a normal position relative to the surface of said label, said second part mounting means comprising a section, spaced from said second part, adapted to be affixed to the surface of said label and expandable means, interposed between said section and said second part, for facilitating displacement of said second part relative to said normal position.
2. The device of Claim 1, wherein said second part mounting means comprises a member and wherein said expandable means comprises one or more accordion-like folds in said member.
3. The device of Claim 1, wherein said expandable means extends in a direction substantially parallel to said surface of said label.
4. The device of Claim 1, wherein said expandable means extends in a direction substantially perpendicular to said surface of said label.
5. The device of Claim 1, wherein said second part mounting means further comprises a second section extending between and joining said expandable means and said second part.
6. The device of Claim 4, wherein said second section is affixed to said second part at a point on the under surface of said part adjacent the side of said part.
7. The device of Claim 1, wherein said first part further comprises means adapted to cover said expandable means when said first and second parts are interengaged.
8. The device of Claim 7, wherein said cover means comprises a flange-like element extending from said first part.
9. The device of Claim 8, wherein said element comprises a body portion and an unattached end, said body portion being adapted to be situated in registration with said expandable means and said end being adapted to contact the surface of said second part mounting means, when said parts interengage.
10. The device of Claim 9, wherein said body portion is resilient and biases said end into contact with said surface, when said parts are interengaged.
11. The device of Claim 1, further comprising second means for releasably connecting said pouch and said label, said second connecting means comprising first and second auxiliary interengaging parts, means for mounting one of said auxiliary interengaging parts to said pouch and means for mounting the other said auxiliary interengaging parts to said label.
12. The device of Claim 10, wherein said auxiliary interengaging parts comprise a hook and eye.
13. The device of Claim 10, wherein said auxiliary interengaging parts comprise a protrusion and an aperture.
14. The device of Claim 1, wherein said interengaging parts comprise a protrusion and groove.
15. The device of Claim 1, wherein said interengaging parts are annular.
16. The device of Claim 1, wherein said interengaging parts comprise a ring-shaped protrusion and a ring-shaped groove.
17. The device of Claim 1, wherein said first part comprises a ring-shaped protrusion and said second part comprises a ring-shaped groove.
18. The device of Claim 1, wherein said first part comprises a ring-shaped groove and said second part comprises a ring-shaped protrusion.
19. The device of Claim 1, further comprising a bead situated along the interior edge of said section of said second part mounting means.
20. The device of Claim 1, wherein the interior edge of said section of said second part mounting means is rounded.
21. The device of Claim 1, further comprising means for retaining said expandable means in the expanded condition.
22. The device of Claim 21, wherein said retaining means comprises an element interposable between said second part mounting means and said label.
23. The device of Claim 21, wherein said retaining means is detachable.
24. The device of Claim 21, wherein said retaining means comprises a ring-like element.
25. The device of Claim 21, wherein said retaining means is composed of elastic material.
26. The device of Claim 21, wherein said retaining means is composed of closed cell foam.
27. The device of Claim 21, wherein said retaining means has a substantially circular cross-section.
28. The device of Claim 21, wherein said retaining means comprises an upstanding section and a base section.
29. The device of Claim 1, wherein said interengaging parts have an elongated configuration.
30. The device of Claim 1, wherein said interengaging parts have a substantially oval configuration.
31. An ostomy device comprising a pouch, an adhesive-backed label and means for releasably connecting said pouch and label, said connecting means comprising primary means for connecting said pouch and label and secondary means for connecting said pouch and label.
32. The device of Claim 31, wherein said secondary connecting means comprises a protrusion and an aperture.
33. The device of Claim 31, wherein said secondary connecting means comprises a hook and eye.
34. The device of Claim 31, wherein said primary connecting means comprises a protrusion and groove.
35. The device of Claim 31, wherein said primary connecting means comprises a ring-shaped protrusion and a ring-shaped groove.
36. The device of Claim 31, wherein said secondary connecting means are located proximate the top of said primary connecting means.
37. An ostomy device comprising a pouch, an adhesive-backed label and means for releasably connecting said pouch and said label, said connecting means comprising first and second interengaging parts, means for mounting said first part to said pouch, means for mounting said second part to said label, and means extending from said first part and adapted to cover a portion of said second part mounting means proximate to said second part.
38. The device of Claim 37, wherein said second part mounting means comprises expandable means and wherein said portion comprises said expandable means.
39. The device of Claim 37, wherein said second part mounting means comprises a section affixed to the surface of said label and wherein said portion comprises the surface of said second part mounting means between said section and said second part.
40. The device of Claim 37, wherein said cover means comprises an element having a body portion and an unattached end, said body portion being adapted to be in registration with said portion of said second part mounting means and said end being adapted to contact the surface of said second part mounting means, when said parts interengage.
41. The device of Claim 37, wherein said first part comprises a ring-shaped engaging part and wherein said cover means comprises a flange-like element extending from said engaging part.
42. The device of Claim 41, wherein said element has an unattached end and wherein said end is adapted to contact said portion of said second part mounting means, when said parts interengage.
43. An ostomy device comprising a pouch, an adhesive-backed label and means for releasably connecting said pouch and said label, said connecting means comprising first and second interengaging parts, means for mounting said first part to said pouch, means for mounting said second part to said label, said second part mounting means comprising expandable means, and means for retaining said expandable means in the expanded condition.
44. The device of Claim 43, wherein said retaining means comprises an element interposable between said second part mounting means and said label.
45. The device of Claim 43, wherein said retaining means is detachable.
46. The device of Claim 43, wherein said retaining means comprises a ring-like element.
47. The device of Claim 43, wherein said retaining means is composed of elastic material.
48. The device of Claim 43, wherein said retaining means is composed of closed cell foam.
49. The device of Claim 43, wherein said retaining means has a substantially circular cross-section.
50. The device of Claim 43, wherein said retaining means comprises an upstanding section and a base section.
51. The device of Claim 43, wherein said interengaging parts have an elongated configuration.
52. The device of Claim 43, wherein said interengaging parts have a substantially oval configuration.
53. An ostomy device comprising a pouch, an adhesive-backed label, and means for releasably connecting said pouch and said label, said releasable connecting means comprising first and second interengageable parts, each of said parts having an elongated configuration.
54. The device of Claim 53, wherein said interengaging parts have a substantially oval configuration.
EP19830303660 1982-06-24 1983-06-24 Improved ostomy device Expired EP0098718B1 (en)
US391557 1982-06-24
EP87101088.0 Division-Into 1983-06-24
EP0098718A1 true true EP0098718A1 (en) 1984-01-18
EP0098718B1 EP0098718B1 (en) 1988-09-07
ID=23547079
EP19830303660 Expired EP0098718B1 (en) 1982-06-24 1983-06-24 Improved ostomy device
EP19870101088 Expired - Lifetime EP0235563B1 (en) 1982-06-24 1983-06-24 Improved ostomy device
EP (2) EP0098718B1 (en)
JP (1) JPH0429389B2 (en)
CA (1) CA1208093A (en)
DE (1) DE3377896D1 (en)
EP0145187A2 (en) * 1983-11-01 1985-06-19 E.R. Squibb &amp; Sons, Inc. Ostomy appliance
FR2564312A1 (en) * 1984-05-17 1985-11-22 Hollister Inc A coupling device has rings for ostomy
GB2163959A (en) * 1984-08-08 1986-03-12 Craig Med Prod Ltd Ostomy appliance
EP0197783A2 (en) * 1985-04-10 1986-10-15 E.R. Squibb &amp; Sons, Inc. Ostomy appliance
EP0334489A2 (en) * 1988-03-23 1989-09-27 E.R. Squibb &amp; Sons, Inc. Ostomy coupling
GB2244651A (en) * 1990-06-04 1991-12-11 Tokyo Eizai Lab Ostomy appliance
EP0927549A1 (en) 1997-12-30 1999-07-07 Eurotec Beheer B.V. Adapter with floating flange for use with a two-piece stoma system
WO2005070356A1 (en) * 2004-01-19 2005-08-04 Peter Andrew Priest Fistula connector
JPH0236500Y2 (en) * 1985-05-01 1990-10-04
EP0145187A3 (en) * 1983-11-01 1987-02-04 Craig Medical Products Limited Ostomy appliance
EP0197783A3 (en) * 1985-04-10 1988-06-08 E.R. Squibb &amp; Sons, Inc. Ostomy appliance
EP0334489A3 (en) * 1988-03-23 1991-06-19 E.R. Squibb &amp; Sons, Inc. Ostomy coupling
GB2244651B (en) * 1990-06-04 1994-11-02 Tokyo Eizai Lab Ostomy appliance
EP0098718B1 (en) 1988-09-07 grant
DE3377896D1 (en) 1988-10-13 grant
EP0235563A3 (en) 1987-11-04 application
JPH0429389B2 (en) 1992-05-18 grant
JPS5940852A (en) 1984-03-06 application
CA1208093A1 (en) grant
EP0235563B1 (en) 1990-10-24 grant
EP0235563A2 (en) 1987-09-09 application
CA1208093A (en) 1986-07-22 grant
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