System for collecting body waste from an anus of a user

Abstract

A system for collecting body waste from an anus of a user, said system comprising: an attachment member arranged to be attached to the perianal skin of a user, said attachment member comprising an attachment flange which is arranged to be attached to the perianal skin surrounding the anus of the user and an opening which is in fluid communication with the anus of the user when the attachment member is attached to the user, and an applicator, having a handle portion and a pressure applying surface arranged at one end of the handle portion, said pressure applying surface being in contact with at least a portion of the attachment flange, said pressure applying surface having an opening which is aligned with the opening in the attachment flange and said handle portion having a through going recess which is aligned with the opening in the pressure applying surface such that a user of the applicator can look through the handle portion and through the opening in the pressure applying surface to the opening in the attachment flange when the pressure applying surface of the applicator is in contact with the attachment flange. In this way, the user of the applicator can more easily and more precisely place the attachment member on a user.

Description

[0001] System for collecting body waste from an anus of a user

[0002] The current invention relates to a system for collecting body waste from an anus of a user, said system comprising: an attachment member arranged to be attached to perianal skin surrounding the anus, said attachment member comprising an attachment flange which is arranged to be attached to said skin such that a fluid tight seal is established between the attachment flange and said skin entirely around the anus when the attachment member is attached to the user, said attachment flange comprising a skin friendly adhesive layer with a skin facing surface and an opening in the attachment flange which is in fluid communication with the anus when the attachment member is attached to the user.

[0003] For the sake of this specification, the term “body waste” should be interpreted as both hard / solid and soft / liquid faecal waste unless otherwise indicated.

[0004] It should be noted that the present specification discloses at least two inventions. A first invention, related to an inventive type of system for collecting body waste from a user is defined in the claim set. A second invention related to another inventive type of hybrid system for collecting body waste from a user is defined by examples in the description. A divisional application directed to the second invention could be filed in the future. Other inventions disclosed in the specification could also be the subject of potential divisional applications in the future.

[0005] It should also be noted that comments with regards to understanding of this specification made in respect to one invention, could also read on the other inventions unless otherwise specifically mentioned. Likewise, examples or features of embodiments provided with regards to one specific invention, could also be applicable to the other inventions, if the person skilled in the art would consider the features to be relevant for the other inventions based on the teachings of this specification.

[0006] Description of related art

[0007] Prior art systems for collecting body waste from a user are well known in the art. Some relevant examples are disclosed in applicant’s own pending applications, see especially WO2018 / 050856, WO2019 / 179586 and W02020 / 182923 which are incorporated by reference in this application.

[0008] The above-mentioned examples are mainly related to systems for collecting liquid or very soft or fluid faecal matter from a user. Applicant’s co-pending application WO2024252013 which is incorporated by reference in this application discloses a type of system which is suitable for collecting hard or solid faecal matter from a user.

[0009] Summary of the invention

[0010] A first aspect of the first invention is to provide a system with an easier attachment process for attaching the body waste collecting system to the user.

[0011] A second aspect of the first invention is to provide a system which allows for a more secure attachment to the user.

[0012] A third aspect of the first invention is to provide a system which is easy to use for the caretaker.

[0013] The above mentioned aspects are provided via a system for collecting body waste from an anus of a user, said system comprising: a. an attachment member arranged to be attached to the perianal skin of a user, said attachment member comprising an attachment flange which is arranged to be attached to the perianal skin surrounding the anus of the user such that a fluid tight seal is established between the attachment flange and the perianal skin of the user entirely around the anus, said attachment flange comprising i. an outer periphery defining a first enclosed area, ii. a skin facing surface, iii. a backing surface facing away from the skin, iv. an opening with an outer periphery, said opening being arranged in the first enclosed area and passing through the attachment flange such that the opening is in fluid communication with the anus of the user when the attachment member is attached to the user, v. a central portion extending from an outer periphery of the opening to an outer periphery of the central portion which is larger than and which encloses the outer periphery of the opening, vi. an outer portion extending from an outer periphery of the central portion to the outer periphery of the attachment flange, and vii. a skin friendly adhesive layer arranged on the skin facing surface of the central portion and the outer portion, and b. an applicator, said applicator having a handle portion and a pressure applying surface arranged at one end of the handle portion, said pressure applying surface being in contact with at least a portion of the backing surface of the central portion of the attachment flange, said pressure applying surface having an opening which is aligned with the opening in the attachment flange and said handle portion having a through going recess which is aligned with the opening in the pressure applying surface such that a user of the applicator can look through the handle portion and through the opening in the pressure applying surface to the opening in the attachment flange when the pressure applying surface of the applicator is in contact with the backing surface of the central portion of the attachment flange.

[0014] In this way, when applying the attachment member to the user via the applicator, the opening in the attachment flange can be directly and easily aligned with the anus of the user. This ensures a much better fit and a faster procedure. In some embodiments, the through going recess is arranged along a longitudinal axis of the handle portion. It should however be noted that the through going recess does not have to be aligned with the longitudinal axis of the handle portion. In the embodiments shown in the figures, there is an opening in the rear of the handle portion through which the person using the applicator can look to see through the hollow handle to the opening in the pressure applying surface. However, there are also openings in the side of the handle portion, whereby a person / user using the applicator can look through the openings in the side of the handle portion and see through the hollow handle and through to the opening in the pressure applying surface, see for example figure 26. If the opening in the end portion of the applicator were closed, a person using the applicator could still guide the attachment member into position by looking through the openings in the side of the applicator.

[0015] Likewise, the term “aligned” should be understood broadly. For example, in the claim the opening in the pressure applying surface is “aligned” with the opening in the attachment flange. However, this just means that at least a portion of the opening in the pressure applying surface overlaps with the opening in the attachment flange so that a person using the applicator can look through both the opening in the pressure applying surface and the opening in the attachment flange to guide the attachment flange properly into place around the anus of a user.

[0016] In some embodiments, the distance X from the outer periphery of the opening to the outer periphery of the central portion is less than the distance Y from the outer periphery of the central portion to the outer periphery of the attachment flange. In some embodiments, the distance X is less than 50%, less than 40% or less than 30% of the distance Y. In some embodiments, the central portion has an elongation per unit force applied along the attachment flange which is higher than the elongation per unit force of the first portion. In some embodiments, the elongation per unit force of the central portion is at least 150% I Newton for a 15mm wide strip of material of the central portion. For more details of the test for elongation per unit force, the reader is referred to applicant’s co-pending application WO2024252013. In some embodiments, the central portion is arranged such that a dimension D4 of an “opening” vector connecting the outermost points of the outer periphery of the central portion in a sagittal plane of a user when connected to a user, is greater than 20mm and less than 80mm.

[0017] In some embodiments, the attachment member further comprises a fluid communication portion which is arranged to provide fluid communication between the opening in the attachment flange and other components of the system, said fluid communication portion being connected to the attachment flange via a ring shaped connection, the outer periphery of the central portion of the attachment flange being arranged at an innermost edge of the ring shaped connection. In some embodiments, a portion of the applicator is arranged inside the fluid communication portion.

[0018] In some embodiments, the fluid communication portion comprises a tubular portion having a first end and a second end, the first end of the tubular portion being connected to the attachment flange via the first ring formed connection and the second end being arranged at an offset from the first end in a direction away from the attachment flange and away from the peri-anal skin of the user when the attachment member is attached to a user, said tubular portion providing a fluid connection between the opening in the attachment flange and the second end of the tubular portion and in that a portion of the applicator which comprises the pressure applying surface of the applicator is arranged inside the tubular portion.

[0019] In some embodiments, the tubular portion and the attachment flange are arranged such that a dimension D6a, in the sagittal plane of a user when the attachment member is connected to a user, from an innermost point of the first ring formed connection to an innermost point of the second end of the tubular portion arranged furthest from the first ring formed connection along a direction which is perpendicular to an “opening” vector connecting the innermost points of the first ring formed connection in a sagittal plane of a user when the attachment member is connected to a user is greater than a dimension D6b in a plane which is perpendicular to said “opening” vector, from an innermost point of the first ring formed connection to an innermost point of the second end of the tubular portion along a direction which is perpendicular to the “opening” vector.

[0020] In some embodiments, the pressure applying surface is formed complementary to the attachment member, such that the distance from a base portion of the applicator to a portion of the applicator which will be in contact with dorsal and ventral portions of the attachment flange when the applicator is used to apply an attachment member to a user is greater than a distance from the base portion of the applicator to a portion of the applicator which will be in contact with side portions of the attachment flange, said distances being parallel to a vector which is on the sagittal plane when the attachment member is connected to the user and perpendicular to the “opening” vector.

[0021] In some embodiments, the attachment member further comprises a collection system engaging portion comprising a flexible flange and an opening in said flexible flange, said opening in said flexible flange being in fluid communication with the opening in the attachment flange. In some embodiments, the flexible flange of said collection system engaging portion is arranged to be folded in half due to the press of the buttocks of the user.

[0022] In some embodiments, the second end of the tubular portion is attached to the flexible flange of the collection system engaging portion via a second ring shaped connection surrounding the opening in the flexible flange.

[0023] In some embodiments, the system further comprises a collection bag, said collection bag comprising i. a reservoir for collecting and storing faecal matter from the user, ii. an opening which is in fluid communication with the reservoir, and iii. a flexible surface surrounding the opening for detachably attaching the flexible surface of the collection bag to the flexible flange of the collection system engaging portion of the attachment member via an adhesive.

[0024] In some embodiments, the flexible surface of the collection bag and the flexible flange of the bag engaging portion of the attachment member are both roughly folded in half when the collection bag is attached to the attachment member. In some embodiments, the applicator comprises flange holding elements arranged on either side of the applicator to detachably hold side edges of the attachment flange along sides of the applicator. In some embodiments, where the attachment member comprises a collection system engaging portion, the flange holding elements also hold the side edges of the flexible flange of the collection system engaging portion along the sides of the applicator.

[0025] In some embodiments, the flange holding elements each have two positions, a first position in which they are spaced apart from the sides of the applicator and a second position where they are held closer to the sides of the applicator and in which they hold the side edges of the attachment flange. In some embodiments where the attachment member comprises a bag engaging portion, the flange holding elements also hold the side edges of the flexible flange of the bag engaging portion in the second position. In some embodiments, the flange holding elements are held in place via a snap mechanism in the second position. In some embodiments, the flange holding elements are pivotably attached to the sides of the applicator. In some embodiments, the flange holding elements comprise a clamping element having a first edge which is proximal to the pressure applying surface and a second edge which is arranged distal to the pressure applying surface, said second edge being pivotably attached to the sides of the applicator about a pivot axis.

[0026] In some embodiments, an angle A between a “skin facing surface" vector in the sagittal plane when the attachment member is attached to a user which is parallel with the skin facing surface of the adhesive layer of the attachment flange and a “tubular portion” vector in the sagittal plane when the attachment member is attached to a user which is parallel to an inner surface of the tubular portion is greater than 70 degrees. In some embodiments, the inner diameter of the opening in the flexible flange of the collection system engaging portion is greater than or equal to the inner diameter of the first ring formed connection. In some embodiments, the angle A is greater than 90 degrees. In some embodiments, a forward portion of the applicator has a side surface which tapers with an angle of more than 90 degrees to the horizontal.

[0027] In some embodiments, the opening of the collection system engaging portion is essentially aligned with the opening in the attachment flange. In some embodiments, the first ring formed connection has a minimum internal diameter which is greater than 30mm. In some embodiments, the outermost 5mm of the attachment flange and the outermost 5mm of the flexible flange of the collection system engaging portion are arranged such that the outermost portions of the two flanges can displace relative to each other. In some embodiments, the attachment flange has an outer diameter which is larger than an outer diameter of the first ring formed connection. In some embodiments, the flexible flange of the collection system engaging portion is displaced from the outer circumference of the attachment flange. In some embodiments, the attachment flange is made of a stretchable elastic material while the flexible flange of the collection bag is made of an essentially plastic material. In some embodiments, the opening in the attachment flange is oval in shape.

[0028] In some embodiments, the handle portion of the applicator has a hollow portion connected to the opening in the pressure applying surface and an opening in one or more sides of the handle portion, to allow a person using the applicator to look through the opening in the one or more sides of the handle portion, through the hollow portion and through the opening in the pressure applying surface.

[0029] In some embodiments, the applicator comprises engagement means to hold the attachment member attached to the applicator during application of the attachment member to a user. In some embodiments, the engagement means comprise an adhesive arranged on the applicator which is in contact with the attachment member. In some embodiments, the adhesive is chosen such that the bond between the attachment member and the applicator is weaker than the bond between the attachment member and the perianal skin of a user when the attachment member is applied to a user. In this way, once the attachment member has been attached to a user, the applicator can be removed without pulling the attachment member away from the skin of the user.

[0030] In some embodiments, the engagement means are friction means which increase the friction between the attachment member and the applicator. In some embodiments, the engagement means are protrusions on the applicator which stretch a portion of the attachment member over the protrusions when the attachment member is mounted on the applicator. In some embodiments, the protrusions stretch the tubular portion of the attachment member.

[0031] In some embodiments, the engagement means are arranged together with the pressure applying surface of the applicator.

[0032] The current specification also discloses a second invention. The second invention relates to a hybrid system. In the prior art many systems for collecting faecal matter from an anus of a user are disclosed. The prior art systems are typically designed to be used either with hard faecal matter or with fluid faecal matter. While some systems can be used for both types, they will typically be more optimized for one type of faecal matter than the other. In some cases it can therefore be desired to switch quickly between one type of system and the other on a single user. Prior art systems would require the one type of system to be detached from the user, and another system attached. This causes extra work for the people working with the system and extra inconvenience and in some cases pain and / or potential for injury to the user.

[0033] It is therefore a first aspect of the second invention to provide a hybrid system which allows for easy exchange between a collection system for hard faecal matter and a collection system for fluid faecal matter.

[0034] The second invention is described with regards to the examples below. A potential divisional application could be filed using the examples below as claims. Note that Ex. 1 refers to Example 1 , Ex. 2 refers to Example 2, etc.

[0035] Ex. 1.A system for collecting body waste from an anus of a user, said system comprising: a. an attachment member arranged to be attached to the perianal skin of a user, said attachment member comprising: i. an attachment flange which is arranged to be attached to the perianal skin surrounding the anus of the user such that a fluid tight seal is established between the attachment flange and the perianal skin of the user entirely around the anus, said attachment flange comprising a skin friendly adhesive layer with a skin facing surface, ii. an opening in the attachment flange which is in fluid communication with the anus of the user when the attachment member is attached to the user, iii. a collection system engaging portion comprising a flexible flange and an opening in said flexible flange, and iv. a fluid communication portion arranged between the attachment flange and the collection system engaging portion, said fluid communication portion providing a fluid connection between the opening in the attachment flange and the opening of the flexible flange of the collection system engaging portion, a first portion of the fluid communication portion being connected to the attachment flange via a first ring formed connection and a second portion of the fluid communication portion being connected to the flexible flange of the collection system engaging portion via a second ring formed connection, b. an elongated collection system comprising an elongated conduit having an internal cross sectional area and an attachment flange arranged at one end of the conduit, said attachment flange having an opening and an outer periphery, said outer periphery being larger than the opening and said opening being in fluid communication with the elongated conduit, said attachment flange having a skin facing surface with a skin friendly adhesive which is suitable for being attached to the perianal skin of a user surrounding the anus of the user to providing a fluid tight seal between the perianal skin of the user and the attachment flange, and c. a flexible sheet element having an outer periphery and an opening passing through the flexible sheet element, said flexible sheet element having a first surface and an opposing second surface, said first surface being arranged to be attached to the flexible flange of the collection system engaging portion of the attachment member via an adhesive, said second surface being arranged to be attached to the attachment flange of the elongated collection system, said opening in the flexible sheet element having a smaller area than the opening in the flexible flange of the collection system attachment portion of the attachment member. Ex. 2. A system according to claim 1 , characterized in that the elongated conduit is longer than 30cm.

[0036] Ex. 3. A system according to example 1 or 2, characterized in that the opening in the flexible flange of the collection system engaging portion is circular or oval and in that the opening in the flexible sheet element is more oval than the opening in the flexible flange of the collection system engaging portion of the attachment member.

[0037] Ex. 4. A system according to any one of examples 1 to 3, characterized in that the outer periphery of the flexible sheet element is essentially the same as an outer periphery of the flexible flange of the collection system engaging portion.

[0038] Ex. 5. A system according to any one of examples 1 to 4, characterized in that the outer periphery of the flexible sheet element is essentially the same as or greater than the outer periphery of the attachment flange of the elongated collection system.

[0039] Ex. 6. A system according to any one of examples 1 to 5, characterized in that the opening in the flexible sheet element is smaller than the opening in the attachment flange of the elongated collection system.

[0040] Ex. 7. A system according to any one of example 1 to 6 characterized in that the system further comprises a bag collection system, said bag collection system comprising: a. a reservoir for collecting and storing faecal matter from the user, b. an opening which is in fluid communication with the reservoir, and c. a flexible surface surrounding the opening for detachably attaching the flexible surface of the bag collection system to the flexible flange of the collection system engaging portion of the attachment member via an adhesive.

[0041] Ex. 8. A system according to any one of claims 1 to 7, characterized in that the fluid communication portion is a tubular portion where the first portion is a first end of the tubular portion and the second portion is a second end of the tubular portion.

[0042] It should be emphasized that the term "comprises / comprising / comprised of" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0043] Brief description of the drawings

[0044] In the following, the invention will be described in greater detail with reference to embodiments shown by the enclosed figures. It should be emphasized that the embodiments shown are used for example purposes only and should not be used to limit the scope of the invention.

[0045] Figure 1 schematically shows a side cross section view of some of the components of an embodiment of a body waste collecting system according to the first invention attached to a user.

[0046] Figure 2 shows a second view of the attachment member of the system of figure 1 showing some descriptive dimensions. Figure 3 schematically shows a cross section through an embodiment of an attachment member of a system according to the first invention, said cross section taken on a sagittal plane of a user when the attachment member is attached to the user.

[0047] Figure 4 schematically shows a cross section through the attachment member of figure 3, said cross section taken on a plane which is perpendicular to the sagittal plane when the attachment member is attached to the user and parallel to a central axis passing through the tubular portion of the attachment member.

[0048] Figure 5 schematically shows a cross section through an embodiment of an attachment member and an applicator of a system according to the first invention, said cross section taken on a sagittal plane of a user when the attachment member is attached to the user.

[0049] Figure 6 schematically shows a cross section through the attachment member of figure 5, said cross section taken on a plane which is perpendicular to the sagittal plane when the attachment member is attached to the user and parallel to a central axis passing through the tubular portion of the attachment member.

[0050] Figure 7 schematically shows a cross section through another embodiment of an attachment member and an applicator of a system according to the first invention, said cross section taken on a sagittal plane of a user when the attachment member is attached to the user.

[0051] Figure 8 schematically shows a cross section through the attachment member of figure 7, said cross section taken on a plane which is perpendicular to the sagittal plane when the attachment member is attached to the user and parallel to a central axis passing through the tubular portion of the attachment member.

[0052] Figure 9 shows a perspective view of an applicator of a system according to the first invention in an open configuration.

[0053] Figure 10 shows a perspective view of the applicator of figure 9 in a closed configuration.

[0054] Figure 11 shows a perspective view of the applicator of figure 9 in a closed configuration and with a partial attachment member mounted on the applicator.

[0055] Figure 12 shows a side view of the applicator of figure 9 in an open configuration.

[0056] Figure 13 shows a side view of the applicator of figure 9 in a closed configuration.

[0057] Figure 14 shows a side view of the applicator of figure 9 in a closed configuration and with a partial attachment member mounted on the applicator.

[0058] Figure 15 shows a bottom perspective view of the applicator of figure 9 in an open configuration.

[0059] Figure 16 shows a bottom perspective view of the applicator of figure 9 in a closed configuration. Figure 17 shows a bottom perspective view of the applicator of figure 9 in a closed configuration and with a partial attachment member mounted on the applicator.

[0060] Figure 18 shows a cross sectional view of the applicator of figure 9 as defined according to the line XVI I l-XVI 11 in figure 9.

[0061] Figure 19 shows a cross sectional view of the applicator of figure 9 as defined according to the line XIX-XIX in figure 9.

[0062] Figure 20 schematically shows a side cross section view of some of the components of an embodiment of a body waste collecting system according to the second invention attached to a user with a bag collection system attached directly to the attachment member for collecting hard stool.

[0063] Figure 21 schematically shows a side cross section view of the system according to the second invention with an elongated collection system attached to the attachment member for collecting liquid or very soft stool.

[0064] Figure 22 shows an exploded perspective view of an embodiment of an applicator and an attachment member in a folded state.

[0065] Figure 23 shows a perspective view of the attachment member of figure 22 in an unfolded state.

[0066] Figure 24 shows a perspective view of the folded attachment member of figure 22 mounted on the applicator of figure 22.

[0067] Figure 25 shows a perspective view of the unfolded attachment member of figure 22 and 23 mounted on the applicator of figure 22. Figure 26 shows a perspective view of the unfolded attachment member on the applicator from the side and below.

[0068] Detailed description of the embodiments

[0069] Figure 1 shows a schematic illustration of a portion of a system 100 for collecting body waste from a user according to the first invention. The system comprises an attachment member 102 and a collection bag 104 detachably connected to the attachment member. The attachment member comprises an attachment flange 106 which is attached to the perianal skin 108 surrounding the anus 110 of the user 112.

[0070] The attachment flange comprises a flange member 114 and an adhesive layer 116 arranged on a skin facing side of the flange member. The attachment member comprises a fluid communication portion 118, which in this embodiment is a tubular portion 118 having a first end 120 and a second end 122. The first end is attached to the attachment flange via a first ring formed or annular connection 124. In this embodiment, the tubular portion and the flange member are integral parts of a moulded silicon component.

[0071] The second end of the tubular portion is provided with a collection system engaging portion 126. In this embodiment, the collection system engaging portion is arranged as a bag engaging portion and is suitable to allow a collection bag to be attached to the attachment member. The bag engaging portion is formed as a flexible flange element 126 which is connected to the second end 122 of the tubular portion via a second ring formed connection 123 and extends outwardly from the second end 122 of the tubular portion. The flexible flange element is made from a flexible film like material which can bend and adjust its shape. However, the stretchability of the flexible flange can be less than the stretchability of the attachment flange. In this embodiment, one could consider the tubular portion 118 together with the flexible flange element 126 as a bag engaging portion connected to the attachment flange.

[0072] The collection bag is likewise provided with an attachment member engaging portion 128. In this embodiment, the attachment member engaging portion 128 of the collection bag is also provided as a flexible flange element, which in this embodiment is welded to the collection bag. A layer of adhesive 129 is applied on the flexible flange element of the attachment member engaging portion 128 on the user facing surface of the flange. The flexible flange of the attachment member engaging portion 128 of the collection bag and the flexible flange 126 of the bag engaging portion of the attachment member 102 are arranged to engage with each other in a detachable, but fluid tight manner. In addition, since both engaging portions 126, 128 are flexible, when the two portions are connected together, the combined / connected element is also flexible.

[0073] In this embodiment, the distance D4 between the innermost points of the first ring formed connection in the sagittal plane of the user, when the attachment member is connected to a user, is approximately 40mm. Depending on the size of the user, different products could be provided. In general, the minimum inner diameter D5 of the opening in the attachment flange should be chosen to be large enough to accommodate the largest expected faecal matter, while the outer distance of the first ring formed connection should be chosen small enough to not extend too far into the perineum or Crena Ani. As such the inner diameter (D5) of the opening in the attachment flange should be less than or equal to D4, and the distance D4 should be chosen such that it is large enough to allow a good connection between the attachment flange and the tubular portion, but in general be as small as possible. The outer distance will typically be between 25mm and 80mm. For children an outer distance of 30 / 35mm would be appropriate and for larger adults, an outer distance of 50 / 55mm could be provided. Note that if the distance D5 is less than the distance D4, then the attachment flange will have a central portion 130 which is arranged on the inside of the first ring formed connection. The portion of the attachment flange arranged outside the first ring formed connection could be called the outer portion 132.

[0074] The distance (D6), essentially “perpendicular” to the plane of the attachment flange, between the innermost portion of the first ring formed connection and the innermost portion of the second ring formed connection in the current embodiment is approximately 1cm in the embodiment of figure 1. If the tubular portion is very long, then faecal matter can be “stored” in the tubular portion and it can be difficult to remove when changing the bag. Hence, for the sake of cleaning and convenience, the tubular portion could be less than 3cm in length. In certain embodiments (not shown) the distance can be zero where the flange of the bag engaging portion is attached directly to the attachment flange via an annular connection. However, the distance can be adjusted to fit the specific application. The distance D6 can also be varied around the circumference of the tubular portion, as will be described in more detail later on.

[0075] The inner diameter (D7) of the opening in the flexible flange of the bag engaging portion should be greater than 20mm.

[0076] The outer diameter D8 of the attachment flange should be greater than the inner diameter of the first ring formed connection.

[0077] The flexible flange of the bag engaging portion should extend outwardly from the tubular portion, such that the outer diameter D9 of the flexible flange of the bag engaging portion is greater than D7. The dimensions mentioned herein are illustrated in more detail in figure 2. From figure 1 , it can be seen that the outer periphery 125 of the attachment flange and the outer periphery 127 of the flexible flange of the bag engaging portion are not directly connected. As such, the outer periphery of the attachment flange and the outer periphery of the flexible flange of the bag engaging portion can move individually. In this way, as the attachment member is applied to the user, the dorsal and ventral portions of the attachment flange can easily bend upwardly and attach securely to the perineum and Crena Ani of the user while the dorsal and ventral portions of the flexible flange of the bag engaging portion can remain relatively straight. In this way, a flange of the collection bag does not have to deform very much to connect to the flexible flange of the bag engaging portion of the attachment member.

[0078] It can be imagined that the attachment member is folded in half and then applied to the user between the buttocks around the anus. Before applying to the user, the user’s buttocks can be spread apart to provide more room for applying the attachment member to the user. The dorsal and ventral portions of the attachment flange are bent towards the user to securely connect to the perineum and Crena ani of the user. The flexible flange of the bag engaging portion will also be folded in half due to the press of the buttocks of the user. Then a flange of the collection bag is folded in half, as is known in the art, and the flange applied to the flexible flange of the bag engaging portion of the attachment member. Since the flange of the bag and the flexible flange of the bag engaging portion of the attachment member are both roughly folded in half, they match in shape and an effective seal is provided. Furthermore, as the user moves, the attachment flange will absorb the motions without the motions being transferred to the flexible flange of the bag engaging portion. In this way, the attachment between the user and the attachment member is much more secure and effective when compared to prior art solutions with collection bags attached directly to the perianal skin of a user. It can also be noted that by arranging the flexible flange of the bag engaging portion and the flexible flange of the collection bag to be bendable and arranged between the buttocks of the user during use, the buttocks of the user will squeeze the components together during motion of the user, and thereby increase the effectiveness of the seal between the bag and the attachment member. Furthermore, it has been found that the adhesives used are more effective when warm, and when the components are squeezed together between the buttocks of the user, the adhesive is kept warm and therefore effective. When a bowel movement occurs, the buttocks will part and the flexible flange of the bag engaging portion and the flange of the bag will open and the stool will pass into the collection bag. Once the bowel movement is finished, the buttocks will close, again sandwiching the flexible flange of the bag engaging portion and the flange of the bag between the buttocks.

[0079] The embodiment 200 of figures 3-4 is similar in principle to the embodiment of figure 1 , however there are some differences which will be described below. The collection bag is not described with respect to these figures, but it can be imagined that a similar collection bag could be used as well.

[0080] It can also been seen in this embodiment, that the length of the ventral / dorsal portion 202 of the tubular portion 204 on the sagittal plane is given by D6a and the length of the side portion 206 of the tubular portion on a plane which is perpendicular to the sagittal plane and parallel to a central vector passing through the tubular portion is given by D6b. It can be seen from the figure, that the dimension D6b is less than the dimension D6a. In this way, the side portion of the tubular portion is “shorter” than the dorsal / ventral portions of the tubular portion. Due to this geometry, the attachment flange will fit better to the user and a more secure seal will be provided. Simultaneously, this arrangement also allows the flexible flange of the bag engaging portion to be more “flat” or 2D in the dorsal and ventral portions. In this way, a more secure connection can be provided between the collection bag and the bag engaging portion.

[0081] For the sake of understanding the claims, the connection between the tubular portion and the attachment flange is a first ring formed connection 208. One could imagine a cross section taken through the tubular portion, at the exact location where the tubular portion extends out from the attachment flange. This first ring formed connection has an innermost point 210 and an outermost point 212 on both sides of a central axis of the tubular portion. Likewise, the connection between the tubular portion and the bag engaging portion is a second ring formed connection 214. Again, the second ring formed connection 214 has an innermost point 216 and an outermost point 218. The “length” of the tubular portion can be defined by the distance between the innermost points (210,216) of the first and second ring formed connection, or by the distance between the outermost points (212, 218) of the first and second ring formed connection. In this embodiment, due to the thin wall thickness of the tubular portion, the distance between innermost points and the distance between outermost points is essentially the same.

[0082] It is to be noted that the flexible flange 220 of the bag engaging portion is shown arranged between the buttocks 222 of the user. The flexible flange has been “folded” roughly in half, as can be seen by comparing the position of the flexible flange in the sagittal plane with the position of the flexible flange in the perpendicular plane. Another difference is that the tubular portion 204 is connected to the attachment flange 224 via a thin flange 226 integrally attached to the first end 228 of the tubular portion. The thin flange extends from the tubular portion in towards the opening 230 in the attachment flange. This embodiment, is also easy to clean, since the tubular portion tapers outwardly due to the angle A and the inner portion of the flexible flange is roughly the same diameter as the inner diameter of the second end 232 of the tubular portion. Hence, there are no “trapped” areas which are hard to clean.

[0083] Figures 5 and 6 show views of the same attachment member 200 as shown in figures 3 and 4, however, in this case, an applicator 300 as defined by one element of the system according to the current invention is shown. The figures have been simplified, so that the function of the applicator can be better explained. The buttocks 222 of the user are also shown spread out a bit more to illustrate the orientation of the attachment member during the attachment process.

[0084] The attachment flange 224 of the attachment member is shown in a bit more detail, with a distinction of three separate zones. A first zone, identified by the dimension D1 is the first ring shaped connection 214 and extends between the innermost point 210 of the first ring shaped connection and the outermost point 212 of the first ring shaped connection. Depending on the material thickness of the tubular portion 204, the first zone will be quite narrow, as it only goes from a first side edge of the tubular portion to the second side edge of the tubular portion at the connection between the tubular portion and the attachment flange. A second zone, indicated by the dimension D2, is a portion of the attachment flange which extends from an inner periphery defined by the outermost point 212 of the first ring shaped connection to an outer periphery 250 of the attachment flange 224. A third zone, identified by the dimension D3, extends from the innermost point 210 of the first ring shaped connection to the edge of the opening 230 in the attachment flange. It should be noted that in the terms of the claims, the outer portion in the claims is a combination of the first zone and the second zone while the central portion is the third zone.

[0085] The applicator 300 has a handle portion 302 and a pressure applying surface 304. The pressure applying surface is a surface which is pressed up against a surface of the central zone of the attachment flange which faces away from the skin of the user. The surface which faces away from the skin could be called a “backing surface” using the terms in the claims. The pressure applying surface is arranged at a forward end 306 of the handle portion and inside the tubular portion 204 of the attachment member. As such, the applicator can be inserted into the tubular portion prior to mounting the attachment member on the user. As shown in figures 5 and 6, when the attachment member is attached to the user, the applicator can be used to press the central portion D3 of the attachment flange against the peri-anal skin of the user. In this way, a simple procedure is provided which is easy to use for the person applying the attachment member to the user and ensures a good skin / flange connection.

[0086] As can be seen from the figures, the pressure applying surface of the applicator is provided with an opening 308. Furthermore, the handle portion 302 of the applicator is hollow and the end portion 310 of the applicator is not covered. As such, a through going recess 312 is provided which passes through the applicator. In this way, when the applicator is used to apply the attachment member to the user, the person applying the attachment member to a user is able to look through the handle portion and see the anus of the user and thereby ensure that the attachment flange is perfectly aligned on the user with respect to the anus of the user. This is different from prior art applicators used in similar applicators where it was not possible to see the anus of the user while applying the attachment flange to the user.

[0087] It should be noted that in figures 5 and 6, the forward portion 306 of the applicator is shown to be rectangular such that only the pressure applying surface of the applicator is in contact with the attachment member. However, as will be seen with regards to figures 9 to 19, the forward portion of the applicator could also be formed complementary to the tubular portion of the attachment member. In this way, there can be a slight frictional fit between the tubular portion of the attachment member and the forward portion of the applicator. Due to this, during mounting of the attachment member to the user, the attachment member will be held by the applicator such that it does not fall off the applicator. In certain embodiments, the friction between the tubular portion of the attachment member and the forward portion of the applicator can be increased by extra engaging elements (not shown), for example small protrusions on the surface of the forward portion of the applicator.

[0088] Figures 5 and 6 also schematically show holding elements 314 arranged on either side of the applicator. The holding elements can hold the sides (on either side of the sagittal plane when connected to the user) of the attachment flange and the bag attachment flange against the sides of the applicator such that they are arranged in a compact manner during the application. Once the central portion of the attachment flange has been pressed against the user, then the forward and rearward portions of the attachment flange can be pressed against the perineum and Crena ani of the user. The applicator can then be removed and the sides of the attachment flanges will be released and they can then be pressed against the buttocks of the user.

[0089] Figures 7 and 8 show an alternate form 400 of the applicator. In this case, the details of the applicator are essentially identical to the details of the applicator 300 shown in figures 5 and 6, hence the same reference numerals are used for the same features. However, the main difference is that there is a dorsal and ventral holding element which is pivotably attached to the dorsal and ventral portions of the applicator. The dorsal and ventral holding elements are narrow elements which just hold a narrow portion of the dorsal and ventral portions of the flexible flange of the bag engaging portions against the sides of the applicator. An upper portion of the dorsal and ventral holding elements is arranged to apply pressure to the first zone of the attachment flange, to thereby press the dorsal and ventral portions of the attachment flange against the Crena ani and perineum of the user.

[0090] Figures 9 to 19 show additional detailed views of an applicator 600. The applicator comprises a handle portion 602 which in this embodiment is a rectangular plastic injection moulded housing with a length L which is greater than the width W and thickness T of the housing. A forward portion 604 of the applicator is formed as a tubular element with a forward surface 606 which is arranged as a pressure applying surface. The pressure applying surface is formed with a three-dimensional shape such that end portions 608 are higher than the middle portions 610. This matches the shape of a user’s peri-anal geometry where the end portions engage with the perineum and Crena Ani of the user and the middle portions 610 engage with the perianal skin on either side of the anus and between the Crena Ani and the Perineum.

[0091] In the illustrated embodiment, the forward portion 604 of the applicator is arranged to be complementary to the tubular portion of the attachment member. The tubular portion engages with the forward portion of the applicator in a frictional fit and the attachment member is therefore more securely connected to the applicator.

[0092] The application in the illustrated embodiments also comprises flange holding elements 612 arranged on either side of the applicator. The flange holding elements have an upper edge 614 and a lower edge 616 spaced apart from each other in the vertical direction (in the orientation shown in figure 9). The lower edge 616 is pivotably connected to the handle portion 602 via a flexible foil hinge 618. A hook 620 on each flange holding element is arranged to snap onto a flange 622 on the holding portion of the applicator. The flange holding elements therefore have at least two positions, a first “closed position” as shown in figures 10 and 11 for example and an “open position” as shown in figure 9. In the open position, the attachment flange 224 (hidden in figures 9-19) and the flexible flange of the bag engaging portion 220 can be folded down along the sides of the handle portion. Since the flange holding elements are folded away from the handle portion, they do not interfere with the folding down of the flanges of the attachment member. The flange holding elements can then be folded up and inwards to hold the flanges of the attachment member 200 in place. The flange holding elements are then locked in position by snapping the hook in and over the flange on the handle portion.

[0093] The pressure applying surface 606 comprises an opening 624 and the handle portion also comprises an opening 626 in the rear portion of the handle portion. The handle portion is furthermore formed as a hollow element with a through going opening / recess 628 which connects the opening 624 in the pressure applying surface and the opening 626 in the rear portion of the handle portion. In this way, when a person is applying the attachment member to a user, the person can look through the opening 626 in the rear portion of the handle portion, through the through going opening / recess in the handle portion and through the opening 624 in the pressure applying surface. The person will then be able to see the anus of the user through the opening in the attachment member and will therefore be able to place the attachment flange precisely on the user with respect to the anus of the user. The user is also able to view the anus of the user via the openings 627 in the sides of the handle portion.

[0094] Figures 20 and 21 show two different examples of a flexible or hybrid system which allows the use of a collection bag attached direct to the bag attachment portion of the attachment member (figure 20) and the use of a system with an elongated conduit with a smaller attachment member which is more suitable for liquid or very soft stool. The attachment member is attached to the bag attachment portion via a flexible sheet element which is glued or adhered to the flexible flange of the bag engaging portion. The opening in the flexible sheet element is smaller than the opening in the bag engaging portion. Hence, the smaller opening in the attachment member of the elongated conduit solution fits better with the smaller opening in the attachment member of the conduit setup.

[0095] Additional notes with regards to invention 2 - The hole in the sheet can be made larger if one wants to switch back to a bag, for example, the hole can be cut to a larger size with scissors. One could apply a new flexible sheet element later on if needed again. A more permanent adhesive can therefore be used between the flexible flange of the bag engaging portion of the attachment member and the flexible sheet element. The opening in the flexible sheet element is less than or equal to the opening in the attachment member of the elongated collection system. The flexible sheet element could also be detachably attached to the bag attachment portion.

[0096] Figures 22-26 show some additional views of another embodiment 800 of an applicator and an attachment member 802 according to the invention. In this case, the applicator is very similar in function to the applicator of previous embodiments, hence, this embodiment is not described in great detail. It is to be noted that in this embodiment, the applicator has a handle portion 804 with a more circular cross section instead of the more rectangular cross section of the previous embodiments.

[0097] Furthermore, in this embodiment, the pressure applying surface 806 is provided with two small tabs 808 which extend outwardly from the pressure applying surface. These small tabs function as engaging elements which engage with the tubular portion 810 of the attachment member causing the tubular portion to stretch slightly, thereby increasing the friction between the tubular portion of the attachment member and the forward portion 812 of the applicator. This more securely engages the attachment member with the applicator during application of the attachment member to a user, without making it difficult to remove the applicator from the attachment member once the attachment member is applied to a user since the adhesive bond between the attachment member and the user is much greater than the friction fit between the applicator and the attachment member.

[0098] In this embodiment, the outer diameter of the handle portion of the applicator is less than the outer diameter of the pressure applying surface. In this way, the handle portion of the applicator is less bulky and easier to manipulate with regards to the attachment member and the user. Likewise, as with the previous embodiment, the handle portion has openings 820 in the sides and an opening 822 in the rear of the housing. The body of the handle portion is hollow 824. In this way, the user of the applicator can look through the opening 822 in the rear of the housing through the hollow 824 body of the handle portion and through the opening 826 in the pressure applying surface 806. Likewise, the user of the applicator could alternatively look through one of the side openings 820, through the hollow 824 body and through the opening 826 in the pressure applying surface to guide the attachment flange into the correct position relative to the anus of the user.

[0099] It should be noted that, similar to figure 11 , only a portion 814 of the attachment flange of the attachment member 200 is shown. The main part 224 of the attachment flange (from figures 3-8) is not shown. In a real embodiment, an attachment flange with adhesive like the one 224 from figures 3-8 would be attached to an inwardly extending flange 814 of tubular portion of the attachment member 802. In the embodiment of figures 22-26, an additional outwardly extending flange 816 is provided at the dorsal and ventral portions of the tubular portion of the attachment member to ensure a strong bond of the adhesive attachment flange to the tubular portion of the attachment member. It is to be noted that the figures and the above description have shown the example embodiments in a simple and schematic manner. Many of the specific mechanical details have not been shown since the person skilled in the art should be familiar with these details and they would just unnecessarily complicate this description. For example, the specific materials used and the specific manufacturing procedures have not been described in detail since it is maintained that the person skilled in the art would be able to find suitable materials and suitable processes to manufacture the system according to the current invention.

Claims

32Claims1. A system for collecting body waste from an anus of a user, said system comprising: a. an attachment member arranged to be attached to the perianal skin of a user, said attachment member comprising an attachment flange which is arranged to be attached to the perianal skin surrounding the anus of the user such that a fluid tight seal is established between the attachment flange and the perianal skin of the user entirely around the anus, said attachment flange comprising i. an outer periphery defining a first enclosed area, ii. a skin facing surface, iii. a backing surface facing away from the skin, iv. an opening with an outer periphery, said opening being arranged in the first enclosed area and passing through the attachment flange such that the opening is in fluid communication with the anus of the user when the attachment member is attached to the user, v. a central portion extending from an outer periphery of the opening to an outer periphery of the central portion which is larger than and which encloses the outer periphery of the opening, vi. an outer portion extending from an outer periphery of the central portion to the outer periphery of the attachment flange, and vii. a skin friendly adhesive layer arranged on the skin facing surface of the central portion and the outer portion, and b. an applicator, said applicator having a handle portion and a pressure applying surface arranged at one end of the handle portion, said pressure applying surface being in contact with at33 least a portion of the backing surface of the central portion of the attachment flange, said pressure applying surface having an opening which is aligned with the opening in the attachment flange and said handle portion having a through going recess which is aligned with the opening in the pressure applying surface such that a user of the applicator can look through the handle portion and through the opening in the pressure applying surface to the opening in the attachment flange when the pressure applying surface of the applicator is in contact with the backing surface of the central portion of the attachment flange.

2. A system according to claim 1 , characterized in that the attachment member further comprises a fluid communication portion which is arranged to provide fluid communication between the opening in the attachment flange and other components of the system, said fluid communication portion being connected to the attachment flange via a ring shaped connection, the outer periphery of the central portion of the attachment flange being arranged at an innermost edge of the ring shaped connection.

3. A system according to claim 2, characterized in that the fluid communication portion comprises a tubular portion having a first end and a second end, the first end of the tubular portion being connected to the attachment flange via the first ring formed connection and the second end being arranged at an offset from the first end in a direction away from the attachment flange and away from the peri-anal skin of the user when the attachment member is attached to a user, said tubular portion providing a fluid connection between the opening in the attachment flange and the second end of the tubular portion and in that a portion of the applicator whichcomprises the pressure applying surface of the applicator is arranged inside the tubular portion.

4. A system according to claim 3, characterized in that the tubular portion and the attachment flange are arranged such that a dimension D6a, in the sagittal plane of a user when the attachment member is connected to a user, from an innermost point of the first ring formed connection to an innermost point of the second end of the tubular portion arranged furthest from the first ring formed connection along a direction which is perpendicular to an “opening” vector connecting the innermost points of the first ring formed connection in a sagittal plane of a user when the attachment member is connected to a user is greater than a dimension D6b in a plane which is perpendicular to said “opening” vector, from an innermost point of the first ring formed connection to an innermost point of the second end of the tubular portion along a direction which is perpendicular to the “opening” vector.

5. A system according to claim 4, characterized in that said pressure applying surface is formed complementary to the attachment member, such that the distance from a base portion of the applicator to a portion of the applicator which will be in contact with dorsal and ventral portions of the attachment flange when the applicator is used to apply an attachment member to a user is greater than a distance from the base portion of the applicator to a portion of the applicator which will be in contact with side portions of the attachment flange, said distances being parallel to a vector which is on the sagittal plane when the attachment member is connected to the user and perpendicular to the “opening” vector.

6. A system according to any one of claims 1 to 5, characterized in that the attachment member further comprises a collection system engaging portion comprising a flexible flange and an opening in said flexible flange, said opening in said flexible flange being in fluid communication with the opening in the attachment flange.

7. A system according to claims 3 and 6 characterized in that the second end of the tubular portion is attached to the flexible flange of the collection system engaging portion via a second ring shaped connection surrounding the opening in the flexible flange.

8. A system according to claim 6 or 7 characterized in that the system further comprises a collection bag, said collection bag comprising i. a reservoir for collecting and storing faecal matter from the user, ii. an opening which is in fluid communication with the reservoir, and iii. a flexible surface surrounding the opening for detachably attaching the flexible surface of the collection bag to the flexible flange of the collection system engaging portion of the attachment member via an adhesive.

9. A system according to any one of claims 1 to 8, characterized in that the applicator comprises flange holding elements arranged on either side of the applicator to detachably hold side edges of the attachment flange along sides of the applicator.

10. A system according to claim 9, characterized in that the flange holding elements each have two positions, a first position in which they are spaced apart from the sides of the applicator and a second36 position where they are held closer to the sides of the applicator and in which they hold the side edges of the attachment flange.

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