US-12616603-B2 - Sensor patch for attachment to a base plate

US12616603B2US 12616603 B2US12616603 B2US 12616603B2US-12616603-B2

Abstract

A sensor patch ( 10 ) for attachment to a base plate for an ostomy appliance, where the sensor patch comprises a distal side and a proximal side comprising at least one adhesive layer ( 15 ), a part of the distal side being adapted for attachment to the base plate and the proximal adhesive side being adapted to adhere to the skin surface of a user, where the sensor patch comprises two or more electrodes ( 12 ) and a monitor interface ( 13 ) for forming a connection to a monitor device, and where the sensor patch comprises a central portion and a neck portion, the electrodes extending from the central portion to the neck portion, the neck portion comprising a flexible element being adapted to allow the central portion and the neck portion to be flexibly movable relative to each other.

Inventors

Jais Ask Hansen
Lars Molzen
Lars Stendevad Windeballe
Esben Stroebech
Kamilla Grove Sund

Assignees

COLOPLAST A/S

Dates

Publication Date: 20260505
Application Date: 20200424
Priority Date: 20190426

Claims (12)

1 . A sensor patch adapted for attachment to a base plate for an ostomy appliance, the sensor comprising: a distal side; a proximal side comprising at least one adhesive layer, a part of the distal side is adapted for attachment to the base plate and the at least one adhesive layer of the proximal side is adapted to adhere the senor patch to skin of a user; a central portion provided with an opening adapted for placement around a stoma; a neck portion extending from the central portion, wherein the neck portion is symmetrically shaped relative to a center longitudinal axis of the neck portion; a monitor interface disposed on the neck portion, the monitor interface including a part adapted for releasably and mechanically coupling with a monitor device; a flexible element located between the central portion and the neck portion and comprising a first pair of indents including a first indent formed as a first slit cut laterally into a periphery on a first side of the flexible element and extending toward the longitudinal axis of the neck portion and a second indent formed as a second slit cut laterally into a periphery on a second side of the flexible element and extending toward the longitudinal axis of the neck portion, with the first indent parallel to the second indent; a first aperture formed through the flexible element, with the first aperture located within the periphery of the flexible element, where the first pair of indents and the first aperture of the flexible element allow the central portion and neck portion to flex and move relative to each other; and a plurality of electrodes secured to the sensor patch around the opening in the central portion and secured to the sensor patch on the flexible element and secured to the sensor patch on the neck portion.
2 . The sensor patch according to claim 1 , wherein the first aperture formed through the flexible element is an elongated non-circular through-going aperture.
3 . The sensor patch according to claim 1 , wherein each of the first pair of indents is an elongated slit formed through a thickness of the neck portion.
4 . The sensor patch according to claim 1 , further comprising a separate second pair of indents, with the second pair of indents comprising a third indent and a fourth indent, with the third indent parallel to the fourth indent and parallel to the first indent.
5 . The sensor patch according to claim 1 , wherein the first pair of indents and the first aperture are perpendicular relative to the centre longitudinal axis of the neck portion.
6 . The sensor patch according to claim 1 , further comprising a second aperture formed between the first aperture and the monitor interface, with the second aperture located within the periphery of the flexible element.
7 . The sensor patch according to claim 1 , wherein the first indent and the first aperture comprise rounded edges.
8 . The sensor patch according to claim 1 , wherein the at least one adhesive layer comprises a first adhesive layer and a second adhesive layer that is different from the first adhesive layer.
9 . The sensor patch according to claim 8 , wherein the first adhesive layer covers at least part of the central portion and the second adhesive layer covers at least part of the neck portion.
10 . The sensor patch according to claim 9 , wherein the second adhesive layer extends in radial direction towards the central portion of the sensor patch and overlaps the first adhesive layer of the central portion and an outer rim of the base plate when the sensor patch and the base plate are adhered together.
11 . The sensor patch according to claim 1 , wherein an outer contour of the sensor patch comprises a pear-shape with the neck portion being narrower than the central portion.
12 . The sensor patch according to claim 1 , wherein the plurality of electrodes is disposed on the neck portion in a z-shaped layout pattern to form flexible electrodes.

Description

BACKGROUND Stomal output often contains body fluids and visceral contents that are aggressive to both the skin of a user and to ostomy devices, these have a detrimental effect on the efficiency and integrity of the adhesive materials that are applied to attach the ostomy device to the user's skin surface. For users in general, safe, reliable and efficient ostomy devices are evidently highly desirable. However, a particularly major and persistent concern of a large population of ostomists continues to be failure of the base plate adhesive attaching the ostomy appliance to the user's skin surface, because such failure almost inevitably leads to embarrassing and stigmatising leakage incidents. Such incidents in turn are known from several user interviews to lead to a reduced quality-of-life feeling. Adhesive failure of the base plate adhesive can result from various reasons. Most often, a leakage incident is caused by stomal output entering between the proximal surface of the base plate and the user's skin, e.g. due to less-than-optimal attachment of the base plate to the skin arising from e.g. uneven skin surface or skin folds. This undesirable progression of stomal output “underneath” the adhesive leads to deterioration and/or weakening of the adhesive material carrying the weight and providing the seal of the ostomy appliance. Often such failure happens surprisingly fast and is only detectable for the user once the failure has already become so severe that leakage occurs, requiring immediate change of the ostomy appliance and possibly also of the user's clothes. In other instances, the primary factor of adhesive failure is simply a question of how much time has elapsed since the base plate of the ostomy appliance was first applied to the user's skin surface. In addition to the output from the stoma itself, the peristomal skin surface continuously secretes some moisture (e.g. sweat). To mitigate this, most often adhesives of base plates for ostomy devices include hydrocolloid materials which are capable of absorbing high levels of moisture, thereby stabilizing the polymer matrix of the adhesive material and prolonging the lifetime (“wear time”) of the base plate. However, eventually the adhesion capability of the base plate no longer can support the force exerted on the base plate from the load of the output collecting bag, and the appliance must be replaced. As there can be considerable differences in the severity and/or speed by which adhesive failure and potentially leakage occur, which differences at least to some extent are correlated to various factors including those presented above, a mere indication that failure or leakage is imminent, or that it has already occurred, fails to represent a reliable and satisfactory solution to the problem of avoiding sudden embarrassing and stigmatising leakage incidents in ostomy appliances. In other words, the users of ostomy appliances could greatly benefit from an appliance solution which provides them with better guidance and options regarding how and—not least—how quickly to react to beginning failure or leakage of the adhesive of the base plate of the appliance. More generally, ostomists and health care professionals alike would welcome improvements in ostomy devices to reduce or eliminate the occurrence of sudden leakage incidents. SUMMARY OF THE INVENTION Disclosed is a sensor patch for attachment to a base plate for an ostomy appliance. The sensor patch comprises a distal side and a proximal side comprising at least one adhesive layer, a part of the distal side being adapted for attachment to the base plate and the proximal adhesive side adapted to adhere to the skin surface of a user. BRIEF DESCRIPTION OF THE DRAWING The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. FIG. 1 illustrates a top view of an embodiment of a sensor patch, FIG. 2 illustrates an embodiment of a sensor patch, FIG. 3 is an exploded view of a sensor plate, FIG. 4 illustrates embodiments (A to I) of a sensor patch, FIG. 5 illustrates embodiments (J to O) of a sensor patch, FIG. 6 illustrates a distal view of a sensor patch, FIG. 7 illustrates a distal view of a sensor patch. DETAILED DESCRIPTION In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such