EP4676413A1

EP4676413A1 - Device for cutting out a circular opening in an ostomy bag

Info

Publication number: EP4676413A1
Application number: EP24712337.5A
Authority: EP
Inventors: Serge Martinus Wilhelmus BATEN; Marijn Andreas Antonius BOERBOOM; Adrianus Johannes Maria TORREMANS
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-03-15
Filing date: 2024-03-13
Publication date: 2026-01-14
Also published as: WO2024191300A1; NL1044566B1

Abstract

Described is a device (1) for circularly enlarging an existing opening in a one-piece ostomy bag, which device (1) comprises a base plate (2) having first coupling means (3) and a cutting module (5) having second coupling means (4), which can be brought into a coupled state by cooperation between the first and second coupling means and can be brought into a decoupled state by cancellation of the cooperation, wherein the base plate (2) and the cutting module (5) in the coupled state have a common axis L, wherein the cutting module (5) is rotatable about the common axis L and includes at least one blade (7) extending coaxially distanced from the common axis L and facing the base plate (2) in a coupled state, and the base plate (2) in the coupled state extends to below and cooperates with the at least one blade (7), wherein the base plate (2) is elongated and in the uncoupled state can be inserted through the existing opening in the ostomy bag with a linear movement, and the base plate (2) and the cutting module (5) are rigidly connected to each other in a coupled state, wherein the cutting module (5) and the base plate (2) are jointly rotatable about the common axis L and the base plate (2) extends from the common axis L in a stationary manner below the at least one blade (7).

Description

Device for cutting out a circular opening in an ostomy bag

The invention relates to a device for circularly enlarging an existing opening in a one-piece ostomy bag, which device comprises a base plate with first coupling means and a cutting module with second coupling means, which can be brought into a coupled state by cooperation between the first and second coupling means and can be brought into a decoupled state by cancellation of the cooperation wherein the base plate and the cutting module share a common axis in the coupled state, wherein the cutting module is rotatable about the common axis and includes, at least one blade extending coaxially distanced from the common axis and facing the base plate in the coupled state, and wherein the base plate in the coupled state extends to below the at least one blade and cooperates therewith.

Such a device is known from WO96/38105. This device includes a disc-shaped base plate having an upwardly extending centred tube, over which can be slid a cutting module, which can rotate around the tube. The base plate has a radial slot through which the base plate can be turned into the ostomy bag with a twisting motion. Once in position, the base plate extends inside the bag radially from the opening as the tube extends upward through the opening. Then the cutting module is slid around the tube with the blade facing downward, and by rotating the module, the blade cuts a larger opening in the ostomy bag, while the blade cooperates with the base plate by rotating over it. The blade is in contact with the base plate during the rotating cutting motion with or without intervention of the ostomy bag material to be cut. The base plate prevents the blade from cutting through the closed side of the ostomy bag as well.

Inserting the base plate of the known device is problematic. To place the base plate, the edge of the ostomy bag must be pushed through the slot, and then the base plate must be pushed into the interior of the ostomy bag with a twisting motion. Apart from the fact that this must be performed with two hands, great precision is also required. In addition, the twisting motion is considered troublesome by many patients and nurses.

The invention provides an improved device of the aforementioned kind, wherein the insertion of the base plate is much easier and faster and can also be carried out by motorically less able patients with only one hand. To this end, the device according to the invention is characterized in that the base plate is elongated and can be inserted through the existing opening in the ostomy bag with a linear movement when uncoupled, and the base plate and the cutting module are firmly connected to each other when in coupled state, the cutting module and the base plate being jointly rotatable about the common axis and the base plate extending from the common axis to below the at least one blade.

The design of the device includes an elongated base plate, which can be inserted into the opening of the ostomy bag with a very simple linear movement. The base plate includes first coupling means, which, when the base plate is correctly positioned in the ostomy bag, are located below the opening of the ostomy bag and are thus exposed for cooperation with the cutting module at the opening of the ostomy bag. Whereas in the device from the prior art the coupling between the base plate and the cutting module is achieved by sliding the cutting module around the tube of the base plate where rotation of the cutting module relative to the base plate is envisaged, in the device according to the invention a fixed, in other words stationary, coupling between the base plate and the cutting module is provided. By "stationary" is meant here that the cutting module and the base plate are not rotatable relative to each other when in coupled state. When the cutting module is rotated, the base plate rotates with it. Therefore, the coupling is also called "rotationally fixed," as opposed to that, known from the prior art.

Because the base plate extends from the common axis stationary to below the at least one blade, the base plate is below the blade in the coupled state, preventing the blade from cutting through the other, closed side of the ostomy bag. Stationary here means that the blade and base plate are not rotatable relative to each other. The base plate rotates with the cutting module, so that the blade of the cutting module is constantly received by the rotating base plate during this rotation.

The base plate is preferably dimensioned such that it can be easily slid through the opening of the ostomy bag. Therefore, the width of the base plate is preferably at most the diameter of the existing opening of the ostomy bag. Since ostomy bags usually have a diameter of 10 or 13 mm at production, the width of the base plate is preferably 1 cm or less. The width of the base plate may be narrower locally, as long as the base plate in the coupled state accommodates the blade sufficiently to prevent puncturing/cutting of the closed side of the ostomy bag.

Once the base plate is correctly positioned, with the first coupling means accessible through the existing opening of the ostomy bag to cooperate with the second coupling means of the cutting module, the cutting module is placed on the base plate establishing a stationary coupling between the cutting module and the base plate. In the coupled state, the assembly of base plate and cutting module can then be rotated about the common axis, with the axis running perpendicularly near or through the existing opening of the ostomy bag. By then rotating the assembly about the common axis, the blade of the cutting module cuts around the existing opening of the ostomy bag, forming a circular new opening with a larger diameter. The diameter of the new opening is determined by the distance of the blade from the common axis.

In particular, the device is intended to enlarge the existing opening of the ostomy bag from above, wherein the existing opening of the ostomy bag is facing upward. During the operation of the device, the bag is preferably supported by a flat surface.

In the coupled state, the at least one blade cooperates with the base plate, meaning that in operation of the device, the blade cuts the ostomy bag while the ostomy bag is resting against the base plate. To enlarge the existing opening with as precise a cut as possible, the at least one blade extends from the base plate and the cutting module against or into the base plate when in coupled state. Thus, the ostomy bag is punctured by the blade when the base plate and the cutting module are coupled, after which, by rotating the coupled assembly of cutting module and base plate, the existing opening is enlarged circularly. Preferably, the blade is tapered, the taper then touching the base plate. In an attractive embodiment, in the coupled state, the blade extends into the base plate. The blade thus pierces into the base plate, thus fixing the base plate during the rotary movement not only via the coupling means but also the blade. In addition, this fixes the blade at a fixed distance from the common axis, thus enlarging the opening of the ostomy bag circularly with great accuracy. To this end, the blade preferably extends 0.5 - 1 mm into the base plate. For this purpose, the base plate is made of a material that is softer than the blade.

In an advantageous embodiment of the device according to the invention, the cutting module comprises adjustment means for adjusting the distance between the at least one blade and the common axis, allowing new openings of different diameters in the ostomy bag with the same device. Thus, the device can be used by, for example, a nurse for different patients. However, it is also possible to provide different cutting modules with a fixed distance from the blade, or multiple blades to the common axis. With a cutting module that is appropriate for the opening of his or her stoma, the patient does not run the risk of an unexpected change in the settings that would require re-setting the distance of the blade to the axis. For nurses, it can also be convenient to have a number of cutting modules with a fixed distance of the blade or blades from the common axis. Then there is no need to adjust the distance each time the nurse prepares an ostomy bag for another patient. With such a collection of cutting modules, a single base plate may suffice as long as the base plate extends from the common axis beyond the greatest distance from the blade to the common axis. One might also consider colour-coding for certain sizes of openings, in which case the ostomy bags could have coloured rings on the face around the existing opening corresponding to those of the respective cutting module. Or the stoma may be color-coded with a corresponding colour code, this will make it easier for a nurse caring for multiple ostomy patients to apply the correct opening to the ostomy bags.

In an advantageous embodiment of the invention, the cutting module includes two blades extending opposite each other at equal distances from the axis extending coaxially toward the base plate when in coupled state, and the base plate extending from the common axis stationary to below both blades. In this embodiment, the cutting module includes two blades equidistant from the common axis, which is also the axis of rotation when the coupled assembly is rotated. With two blades positioned opposite each other, the cutting module is more balanced on the base plate which facilitates the cutting motion, and also shortens it to only half a turn. In this case, the base plate extends from the axis to under both blades. The base plate is then pushed further into the ostomy bag to be contained therein, after which it is retracted into the bag in the opposite direction until the common axis is below the existing opening of the ostomy bag.

To further facilitate the insertion of a larger circular opening in an ostomy bag, the device further includes a separate support plate with a circular opening, into which the cutting module can be rotatably inserted. This support plate is then placed above the ostomy bag, into which the base plate is already slid, the position of the opening of the base plate being concentric with the existing opening of the ostomy bag. Next, the cutting module is inserted into the opening of the support plate and coupled with the base plate, whereafter the user can rotate the cutting module around with the cutting module being guided by the support plate during the rotational movement. Thus, unwanted shifting of the cutting module and base plate assembly is prevented during cutting.

To be guided through the opening of the support plate, the cutting module may be circular in shape with an outer circumference corresponding to the inner circumference of the circular opening in the support plate. Thus, the cutting module can be precisely inserted through the circular opening and rotate therein. In an attractive embodiment, the cutting module includes a circular shoulder that allows the cutting module to rest on the support plate around the circular opening of the support plate. As the cutting module rotates, the shoulder of the cutting module slides over the support plate and prevents excessive pressure from being applied to the ostomy bag during cutting.

The cutting module is advantageously rotatably beared in the circular opening of the support plate. Having the cutting module supported in conjunction with the support plate prevents wear that occurs when the shoulder of the cutting module slides across the support plate during the cutting motion, and reduces resistance during the motion, which increases comfort. To this end, the edge of the support plate may include an annular bearing, with the opening of the annular bearing forming the circular opening of the support plate.

In a further embodiment, the cutting module is spring-loaded into the circular opening of the support plate. Accordingly, the user has the option to press the cutting module more or less forcefully against the ostomy bag. To achieve the same effect, it is also possible to spring the support plate as a whole in relation to the surface on which the support plate rests for this purpose.

With advantage, the device includes a centring element, which when coupled can be positioned between the base plate and the cutting module and includes at least one guide element having an outer circumference corresponding to the inner circumference of the circular opening. When such a centring element is used, correct positioning of the cutting module is facilitated. First, the base plate is inserted into the ostomy bag, then the centring element is placed on the base plate, and then the base plate is placed over the ostomy bag, whereby the circular opening of the support plate is placed around the guide element of the centring element, thereby positioning the support plate at the correct position relative to the base plate.

Advantageously, the centring element is designed planar and extends transversely relatively to the common axis between the base plate and the cutting module when in coupled state. The centring element thus lies parallel to the direction of rotation of the cutting module.

The guide element can be designed as a raised edge of the centring element, having an outer circumference corresponding to the inner circumference of the circular opening of the support plate. Alternatively, the centring element may comprise a number of guide elements that are concentric about the common axis in the coupled state of the cutting module and the base plate, for example, which guide elements cooperate with the circular opening of the support plate about the inner circumference thereof. For example, the guide elements may be implemented as raised pins or lugs, which when positioned against the circular edge of the support plate, determine the location of the support plate relative to the base plate.

In an attractive embodiment, the at least one guiding element extends in the coupled state of the base plate and the cutting module coaxially in the direction toward the cutting module, and the cutting module includes at the location of the at least one guiding element a recess for including therein the at least one guiding element. Once the support plate, guided by the guide elements of the support plate is correctly positioned over the ostomy bag, the cutting module is inserted into the circular opening of the support plate and coupled with the base plate. Because the support elements extend along the inner circumference of the circular opening of the support plate, the cutting module includes corresponding recesses to accommodate the guide elements. Thus, the outer circumference of the cutting module may be locally interrupted or truncated to accommodate a guide element. When the guide element of the centring plate is implemented as a circular raised wall, the outer circumference of the cutting module may be at least locally adapted to the inner circumference of this raised wall.

In an attractive embodiment, the centring element comprises two opposing guide elements. Two guide elements with a spacing corresponding to that of the diameter of the circular opening of the support plate are sufficient to accurately determine the positioning of the support plate.

Advantageously, the first and second coupling means are in the coupled state at the location of the common axis. Since the common axis is also the axis of rotation during the cutting movement, and the common axis preferably passes perpendicularly through the existing opening of the ostomy case, and free space is provided at the location of this existing opening without being covered by the ostomy case, the coupling means can then easily cooperate with each other and firmly connect the cutting module to the base plate without damaging the ostomy case. For example, the first coupling means may comprise a button-shaped protrusion, and the second coupling means may comprise a fitting recess, whereby, for example, a snap connection may be established. The coupling means may be asymmetrically designed to couple the cutting module to the base plate in only a limited number of positions, such as one or two positions. This may be necessary to ensure that the single blade or blades of the cutting module are positioned correctly above the base plate. The coupling means may also include additional coupling means under intervention by which the first and second coupling means are coupled together. For example, both the cutting module and the base plate may be provided with holes around the common axis, wherein as additional coupling means comprise a flat ring, provided with rods extending coaxially around the ring opening, which may or may not cooperate with the holes of the cutting module and the base plate, respectively. In an attractive embodiment, the base plate includes grip means to facilitate manual placement thereof in the ostomy bag, preferably extending perpendicularly from the base plate toward the cutting module. These grip means may be part of the coupling means, for example.

The cutting module advantageously includes means for lifting the cooperation between the first and second coupling means to release the cutting module from the base plate. For example, when the coupling is achieved via a snap connection, the base plate is attached to the cutting module, and releasing it may be difficult. T o this end, the cutting module may include, for example, an axially movable component that can be moved from the side of the cutting module facing away from the base plate toward the base plate in order to press against the coupling means and effect release. The means for cancelling cooperation between the first and second coupling means thus advantageously comprise an axially movable release member.

The invention will now be explained in more detail on the basis of the following non-limiting figures. The figures show the same features in the various embodiments with the same reference numbers.

Figuur 1 shows an embodiment of the device according to the invention with two blades. Figuur 2 shows another embodiment of the device according to the invention with two blades. Figuur 3 shows an embodiment of the device according to the invention with a single blade. Figuur 4 shows an embodiment of a support plate for placing a device.

In Figure 1 , device 1 includes a narrow, substantially flat, elongated base plate 2 arranged to be inserted through the existing opening of an ostomy bag. The base plate 2 is provided at the top with first coupling means 3 that can be coupled in a rotationally fixed manner with second coupling means 4 of cutting module 5. L represents the common axis around which the device is rotatably rotatable in the coupled state as shown in Figures 1A-C.

In the illustrated case, the cutting module 5 comprises a frame 6 with, at its bottom, the second coupling means 4 and two blades 7 coaxially extending opposite each other at equal distances from the axis L, e.g. fixed with socket head screws. Frame 6 is covered by a housing 8 which also functions as a turning handle. The base plate 2 extends from the common axis L to below and beyond both blades.

The foregoing is arranged and implemented such that the base plate 2 can be inserted through said existing opening inside the ostomy bag, whereby the first coupling means then extend through the existing opening of the ostomy bag, whereby the cutting module 5 can be positioned on the base plate 2, whereby the first and second coupling means cooperate with each other, engage with each other and form a rotationally fixed coupling between cutting module 5 and base plate 2. Blades 7 of the cutting module 5 can thereby be pushed through the material of the ostomy bag and thereby be received against the surface of the base plate 2, whereby by rotation of the cutting module 5 and the base plate 2 rotationally coupled therewith, the blades 7 can cut out a circular opening from the material of the ostomy bag, the base plate rotating with the cutting module. Figure 2 shows an embodiment of a device according to the invention, modified with respect to the embodiment of figure 1 , wherein the frame and housing of the cutting module of the embodiment according to figure 1 are formed of a single piece, for example of plastic or metal. The cutting module includes a circular shoulder 13 to be inserted in a circular opening of a support plate shown in Figure 3.

Figure 3 shows an embodiment of a device according to the invention, modified with respect to the embodiment of Figure 2, wherein the cutting module comprises only a single blade 7, and the circular shoulder is truncated at two opposite locations therewith forming two opposing recesses 14. Centering element 10 includes on its outer circumference two opposing guide elements 15, which when in coupled state extend from the base plate 2 and the cutting module 5 toward the cutting module and can then be included in the space provided by the recesses 14. In the coupled state of the cutting module and the base plate, blade or blades 7 extend through openings 20 provided for that purpose. The single-blade device may have a base plate as shown in Figure 1 D and in the cross-sectional view of the assembly of Figure 3C, or a base plate as shown in Figure 3D, in the latter case it is to be ensured that the knife 7 is located above the base plate when the cutting module 5 and the base plate 2 are in coupled state. This can be easily achieved by designing the first and second coupling such that the base plate can only be coupled with the cutting module in a single orientation, where in that orientation the blade is located above the base plate 2.

Figure 4 shows an embodiment of a support plate 9 for positioning a device 1 according to the invention. The support plate 9 includes an annular bearing 19 that defines a circular opening 12. The support plate 9 can be simply placed over the guide elements 15 of centring element 10 to center the ostomy bag in the circular opening 12. To do this, base plate 2 is first inserted through the existing opening in the ostomy bag, with the first coupling means 3 protruding out through the existing opening. Next, centring element 10 is placed on the base plate with the guide elements facing away from the base plate. As shown herein, the base plate and the centring device may be provided with positioning means, such as a centred opening 16 in the centring device 10, and a matching raised round edge 17 on the base plate 2. Next, the cutting module is placed on the base plate and rotationally coupled to the base plate.

The circular opening 12 of the support plate 9 may be stepped in order to allow the cutting module 1 to be inserted into the circular opening 12 without pushing it therethrough. However, a free passage of the cutting module through the circular opening is also a possible embodiment.

The ostomy bag can thus be placed on a table, with the plate of the auxiliary device 9 over it, after which very stably and even using one hand the desired larger opening can be cut into the ostomy bag.

Claims

1. Device (1) for circularly enlarging an existing opening in a one-piece ostomy bag, which device (1) comprises a base plate (2) with first coupling means (3) and a cutting module (5) with second coupling means (4), which can be brought into a coupled state by cooperation between the first and second coupling means and can be brought into a decoupled state by cancellation of the cooperation, wherein the base plate (2) and the cutting module (5) in the coupled state have a common axis L, where the cutting module (5)

- Rotatable about the common axis L and

- includes at least one blade (7) extending coaxially distanced from the common axis L and facing the base plate (2) in the coupled state, and the base plate (2)

- when in coupled state extends to below the at least one blade (7) and cooperates therewith, characterized in that

- the base plate (2) is elongated and can, in uncoupled state, be inserted through the existing opening in the ostomy bag with a linear movement, and

- the base plate (2) and the cutting module (5) are fixedly connected to each other in the coupled state, wherein the cutting module (5) and the base plate (2) are jointly rotatable about the common axis L and the base plate (2) extends in a stationary manner from the common axis L to below the at least one blade (7).

2. Device according to claim 1 , characterized in that the at least one blade (7) extends against or into the base plate (2) and the cutting module (5) in the coupled state.

3. Device according to claim 1 or 2, characterized in that the cutting module comprises adjustment means for adjusting the distance between the at least one blade and the common axis L.

4. Device according to any of the preceding claims, characterized in that that the cutting module comprises two blades (7) extending opposite each other at equal distances from the axis L coaxially, facing the base plate (2) when coupled, and the base plate (2) extending from the common axis L stationary to below both blades (7),

5. Device according to any of the preceding claims, characterized in that the device further comprises a separate support plate (9) with a circular opening (12) in which the cutting module (5) can be rotatably inserted.

6. Device according to claim 5, characterized in that the cutting module (2) includes a circular shoulder (13) that allows the cutting module (5) to rest around the circular opening (12) of the support plate (9) on the support plate (9).

7. Device according to claim 5 or 6, characterized in that the cutting module is rotatably supported in the circular opening (12) of the support plate (9).

8. Device according to any one of conclusions 5 - 7, characterized in that the cutting module is spring-loaded into the circular opening (12) of the support plate (9).

9. Device according to any one of claims 5 - 8, characterized in that the device includes a centring element (10), which when coupled can be placed between the base plate (2) and the cutting module (5) and includes at least one guide element (15) with an outer circumference corresponding to the inner circumference of the circular opening (12) of the support plate (9).

10. Device according to claim 9, characterized in that the centring element is planar and extends transversely relative to axis L between the base plate (2) and the cutting module (5) when coupled.

11. Device according to claim 9 or 10, characterized in that the at least one guide element (15) extends in the coupled state from the base plate (2) and the cutting module (5) coaxially in the direction toward the cutting module, and the cutting module (2) includes at the location of the at least one guide element a recess (15) for including therein the at least one guide element.

12. Device according to claim 11 , characterized in that the centring element (10) comprises two opposing guide elements (14).

13. Device according to any of the preceding claims, characterized in that the first and second coupling means are located at the location of the common axis L when in coupled state.

14. Device according to any of the preceding claims, characterized in that the base plate includes grip means extending perpendicularly from the base plate toward the cutting module.

15. Device according to any of the preceding claims, characterized in that the cutting module includes means for cancelling the cooperation between the first and second coupling means to release the cutting module from the base plate.

16. Device according to claim 15, characterized in that the means for lifting cooperation between the first and second coupling means comprises an axially movable releasing element.