CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Danish Application No. PA 2017 00325, filed May 31, 2017 and titled Ostomy Device, the entire contents of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to an ostomy device for use in connection with a stoma. More specifically, the invention relates to a device which is suitable for use with a base plate in such a manner, whereby the stoma can be pinched off or blocked for an extended period of time. Subsequently, discharge from the stoma can be collected and emptied without inducing a risk of leakage. Thereby, the risk for skin irritation due to skin contact with faeces or urine is markedly lowered.

BACKGROUND OF THE INVENTION

In connection with certain diseases such as carcinomas of the colon or rectum, the surgical removal of the bowel (colostomy) or small intestine (ileostomy) or parts thereof is often necessary. After surgery, an artificial opening is created on the body allowing faeces or urine, either from the intestine or the urinary tract, to pass through this opening. The discharge from the ileostomy or colostomy is collected in a stoma pouch or bag.

Ostomy can be performed in different ways. The most common ostomies include colostomy, ileostomy and urostomy, respectively. In a colostomy operation, part of the colon is brought to the surface of the abdomen to form the stoma. There are two types of colostomy, namely end colostomy and loop colostomy. End colostomy is typically performed if parts of the colon and rectum have been removed. Loop colostomy is typically performed as a temporary measure in acute situations, and by this operation, part of the colon is lifted above skin level and held in place with a stoma rod. In an ileostomy operation, a part of the small intestine (the ileum) is brought to the surface of the abdomen to form the stoma. An ileostomy is typically created in cases where the end part of the small intestine is diseased and may be performed as either an end ileostomy or a loop ileostomy. End ileostomy is made in cases where part of the colon is removed (or need to rest), and the end of the small intestine is brought to the surface of the abdomen to form the stoma. In a loop ileostomy, a loop of the small intestine is lifted above skin level and held in place with a stoma rod. A loop ileostomy may be temporary and performed to protect a surgical join in the bowel. By urostomy, an isolated part of the intestine is brought onto the surface of the abdomen and the other end is sewn up, and the ureters are detached from the bladder and reattached to the isolated section of the intestine. Because this section of the intestine is too small to function as a reservoir, and there is no muscle or valve to control urination, a urostomy pouch to collect the urine is needed.

It is known in the art to apply base plates (so-called skin plates) in connection with stomas. The base plates are usually fastened or adhered to the skin around the stoma by use of an adhesive. The plates have an orifice/opening (or it may be possible to provide and orifice/opening) through which the stoma can be transferred. Several types of pouches to fit and to be fastened to the base plates are known in the art.

E.g. from EP 1 795 157 A2 an ostomy appliance for fastening to a base plate is known. The ostomy appliance comprises a m attachment ring, the flange of which is permanently attached to the base plate. The ostomy device further comprises means which are suited for detachably attached to the attachment ring, and a cap having a sealing for the stoma, thereby blocking the stoma. In spite of the sealing cap there is still a risk of leakage from the stoma, if not combined with the use of a stoma pouch.

A number of disadvantages are involved with the use of stoma pouches, including the wearer's reduced mobility and possibility of participating in certain activities (e.g. swimming and bathing as well as other activities where clothing closely fitting the body is required). The wearer may understandably prefer the stoma pouch is not visible beneath the clothing.

Therefore, an alternative to the known stoma pouches is desired.

Furthermore, it is desired to provide a ostomy device which eliminates the wearer's need to discharge the stoma pouch for an extended period of time (e.g. for as long as six hours), while at the same time make possible the release of gas from the stoma.

Object of the Invention

It is an object of the present invention to provide an ostomy device that minimises or even eliminates the above disadvantages.

It is also an object of the present invention to provide an ostomy device that enhances the wearer's mobility, and further makes it possible to participate in various activities without revealing the stoma pouch (e.g. swimming and other activities involving closely fitting clothes).

It is further an object of the present invention to provide an ostomy device which enables pinching off or blocking the stoma for an extended period of time (e.g. for as long as six hours), while at the same time enables release of gas from the stoma.

The object of the present invention is achieved by the ostomy device as defined in claim1. Preferred embodiments are comprised by the dependent claims and further described herein as well as illustrated in the accompanying drawings.

The ostomy device according to the invention is an ostomy device for attachment to (coupling to) a base plate, wherein the ostomy device comprises an attachment ring configured to detachable attachment to the base plate, wherein the ostomy device further comprises elements with means for detachable attachment to the attachment ring, wherein the ostomy device comprises a shield comprising a blocking element, whereby the stoma may be pinched off/blocked, wherein the blocking element is formed and configured to engage with a collecting element and a herein placed distal part of the stoma.

Thereby, the stoma may be pinched off, thus, enabling the wearer's use of the ostomy device for periods of e.g. 2-6 hours without the need for the simultaneous use of a stoma pouch. The blocking element is configured to engage with a collecting element and thereby provide a pressure against the stoma which is thereby pinched off/blocked.

The ostomy device according to the invention may be detachably attached to the base plate through an attachment ring. The ostomy device further comprises elements having means configured for detachable attachment to the attachment ring. These elements may have any suitable shape and geometry.

The shield may have any suitable shape and geometry. However, it may be an advantage that the shield comprises a spherical part (e.g. formed as the surface of a globular structure/dome or an oval structure). The blocking element may suitably have a geometry providing a predefined pressure distribution against the distal part of the stoma, when the blocking element is brought into engagement with a collecting element and the herein placed distal part of the stoma, thereby resulting in the blocking or pinching off of the stoma.

In may be advantageous that the blocking element is displaceably attached to the base plate.

Thereby, the level of blocking or pinching off can be adapted by displacing the blocking element relative to the base plate, since the force and, thus, the pressure by the blocking element acting on the free end of the stoma are defined e.g. by the distance between the blocking element and the base plate. Thus, it is possible to provide a shield having a distance-adjustable blocking element enabling selective adjustment of the blocking of the stoma.

It may be an advantage that the shield is symmetrical, and that the blocking element is centrally placed.

The shield has preferably a convex outer side and a concave part, the latter configured to be placed against the base plate.

It may be an advantage that the ostomy device comprises a closing disc provided with a threaded area, and further that the blocking element is provided with a corresponding threaded area configured to engage with the threaded area of the closing disc. Thereby, the blocking element may be displaced upwards and downwards so as to vary the pressure by the blocking element on the distal end of the stoma in a simple and continuous manner.

It may be an advantage that the closing disc is provided with an internal threaded area extending along an internal cylinder-shaped surface and that the ostomy device comprises a blocking element comprising a cylindrical portion provided with an outer (externally provided) threaded area extending along the outer cylindrical surface of the cylindrical portion.

It may be an advantage that the blocking element is centrally placed on the inner portion of the shield. Thereby, it is possible to provide a shield having a blocking element that can easily be provided with an outer (external) threaded area configured to attachment to a structure (e.g. a closing disc) having a corresponding inner threaded area.

It may be an advantage that the shield covers an area extending along the area of the base plate to which the ostomy device is attached.

Thereby, the shield protects the base plate and ensures that the shield sufficiently covers the area needed.

It may be an advantage that a cavity is present in the central part of the blocking element, wherein the cavity is configured to receive the distal part of a stoma. Thereby, the height of the blocking element (and, thus, the size of the shield may be reduced) may be reduced, since the blocking element may thus receive the part of the stoma to be blocked or pinched off. Thereby, it is possible to place, in the cavity, the stoma as well the free end of the stoma in the collecting element (e.g. a pouch or a condom).

It may be an advantage that the ostomy device comprises a connection member detachably attached to the attachment ring. The application of a detachably mounted/attached connecting element makes it possible to attach and detach the connecting element e.g. when changing collecting elements (e.g. a pouch or a condom). The collecting element may e.g. be attached in a fastening recess provided in the connecting element.

In a preferred embodiment of the invention, the ostomy device comprises a closing disc suited for attachment to the attachment ring or the connecting element. Thereby, it is possible to attach the shield to the closing disc and ensure mechanical attachment to the base plate. It may be preferred that the closing disc is provided with attachment elements for detachable attachment of the shield to the closing disc. It may be an advantage that these attachment elements are configured to enable adjustment of the distance between the closing disc and the base plate.

It may be an advantage that the closing disc comprises a flange having an internal threaded area and comprises an adjacent portion, wherein the flange extends perpendicular to the adjacent portion. Thereby, the stoma can be lead through the opening in the flange, and a flexible collecting element e.g. formed as a pouch (alternatively a condom) may suitably be attached to a ring-shaped attachment recess provided in a connecting element. The collecting element thereby encloses the distal end of the stoma and enables collection of the discharge from the stoma.

It may be an advantage that the shield is provided with one or more grips, e.g. fitting the fingers of the hand. Thereby, the handling of the shield is eased. In a preferred embodiment of the invention, the shield comprises two such finger grips opposed to each other at the periphery of the shield.

It may be an advantage that the lower portion of the closing disc is provided with a number of engagement elements configured to be brought into locking engagement with corresponding openings of an underlying connecting element or an underlying attachment ring. Thereby, it is possible to provide an easy attachment of the closing disc to the underlying connecting element or the underlying attachment ring.

It may be an advantage that the engagement elements are L-shaped. In one embodiment of the invention, the engagement elements are rotatably attached to the closing disc.

In a preferred embodiment of the invention, the L-shaped engagement elements comprise a central portion extending along the longitudinal axis of the closing disc and comprise an engagement structure extending perpendicular to the longitudinal axis of the closing disc.

The closing disc may suitably comprise one, two, three, four, five, six or more engagement elements. In some embodiments of the invention, the engagement elements may be evenly distributed along the lower portion of the adjacent portion of the closing disc. If e.g. three engagement elements are present, the distance between adjacent engagement elements is approximately 120°.

It may be an advantage that the connecting element or the closing disc or both is provided with a number of T-shaped engagement elements configured to be brought in to engagement with corresponding openings of an adjacent attachment ring or an adjacent connecting element. Thereby, it is possible to provide an effective and easy attachment of the closing disc to the attachment ring or the connecting element.

It may be an advantage that the T-shaped engagement elements comprise a central portion extending along the longitudinal axis of the connecting element and comprise two engagement structures extending perpendicular to the longitudinal axis of connecting element. This type of engagement elements makes it possible to rotate the closing disc and, thus, place the closing disc in a number of configurations, whereby the closing disc becomes locked or unlocked relative to the attachment ring or the connecting element.

It may be an advantage that the engagement elements are evenly distributed along the ring-shaped structure of the connecting element.

It may be an advantage that the lower portion of the closing disc is provided with a number of recesses configured to receive protrusions provided on the connecting element.

The number of recesses should preferably at least equal the number of protruding protrusions on the connecting element. The number of recesses may, however, equal the number of protruding protrusions on the connecting elements. Suitably, the number of recesses on the closing disc may be one, two, three, four, five, six or more, depending on the number of protruding protrusions on the connecting element.

The recesses should be provided and distributed such as to angularly correspond to the protruding protrusions on the connecting element, thus, enabling engagement of the protruding protrusions with the recesses.

In one embodiment of the invention, the central portion is rotatably attached to the connecting element, whereby the recesses enable rotation of the engagement elements about the longitudinal axis of the central portion. Thereby, a safe and secure locking is provided by applying simple mechanical means.

It may be an advantage that the attachment ring is provided with openings, each opening being provided with a radial adjacent resilient structure.

The use of a resilient structure for each opening ensures that variations in the different portions are acceptable, while providing easy attachment of the engagement elements to the attachment ring. Furthermore, the resilient structures ensure locking engagement between the openings and the engagement elements.

In one embodiment of the invention, the resilient structure is a wavy/corrugated profile next to the opening and further next to a slit, thus, enabling displacement of the resilient structure, whereby the receipt of a corresponding engagement element of a connecting element is achieved.

In a preferred embodiment, the attachment ring is provided with a centrally placed disc having three openings, each opening provided with a radial adjacent resilient structure.

The openings may advantageously comprise a tangentially extending center structure surrounded by adjacent locking elements configured to provide locking engagement with a connecting element of corresponding engagement elements at the upper portion of the attachment ring.

It may be an advantage that the closing disc comprises an attachment recess configured for receipt and attachment of a collecting element. Thereby, it is possible to attach a collecting element surrounding the distal portion of the stoma, whereby discharge from the stoma may be collected.

It may be an advantage that the attachment recess is annular and has a circular cross-section.

It may be an advantage that the closing disc comprises a peripheral edge extending from the adjacent portion of the closing disc along the longitudinal axis. Thereby, an area is provided enabling the use of an annularly shaped filter.

It may be an advantage that the ostomy device comprises an integrated or built-in filter. Thereby, it is possible to clean/reduce the odour of the gas escaping from the stoma. It may be advantageous to use a carbon filter as this type of filter effectively cleans the gas, thereby markedly reducing the odours from the ostomy device.

It may be an advantage that the connecting element comprises a sealing portion extending along the longitudinal axis of the ostomy device. The sealing portion further ensures retention of discharge gathered by the collecting element attached to the connecting element attached to the attachment recess of the connecting element, which is practical in connection with the removal of the collecting element from the connecting element.

It may be an advantageous to provide one or more engagement profiles for engaging with the shield. The engagement provides may comprise a protruding profile configured to enable rotation of the shield using the engagement profiles.

