Application of stoma sensor patch

Abstract

A method for evaluating the attachment of a sensor patch to a base plate of an ostomy appliance is disclosed, wherein the base plate (4) comprises: at least a first layer of adhesive material (200), the first layer of adhesive material being adapted to attach the base plate to a skin surface of a user; a backing layer (208), the backing layer comprising a membrane material and having a distal surface and a proximal surface; and a central portion, the central portion surrounding a stoma receiving opening (18) extending through the base plate, the sensor patch being adapted to be attached to the first layer of the base plate, and wherein the sensor patch comprises: a sensor assembly comprising a plurality of electrodes, the plurality of electrodes comprising a first electrode and a second electrode for forming a first sensor, the method comprising: measuring one or more characteristic quantities; and determining whether the one or more characteristic quantities meet one or more attachment criteria.

Description

[0001] The present disclosure relates to applying a sensor patch to an adhesive backing of an ostomy appliance. In particular, the present disclosure relates to the manner of sensing application and / or failure of such sensing application. Background Art

[0002] Stoma discharge often contains body fluids and visceral contents that are aggressive to both the user's skin and the ostomy appliance, which can have a detrimental effect on the efficiency and integrity of the adhesive material used to attach the ostomy appliance to the user's skin surface. For the average user, there is clearly a great need for safe, reliable, and efficient ostomy appliances.

[0003] However, the main and lasting concern of a large number of ostomists is still the failure of the base plate adhesive that attaches the ostomy appliance to the skin surface of the user, because such failure almost inevitably leads to embarrassing and shameful leakage events. It is known from several user interviews that such events then lead to a decline in the quality of life. The adhesive failure of the base plate adhesive may be caused by different reasons. The most common is, for example, due to the poor attachment of the base plate to the skin caused by, for example, uneven skin surface or skin wrinkles, and the leakage event caused by the stoma discharge entering the proximal surface of the base plate and the skin of the user. This undesirable progress of the stoma discharge "below" the adhesive causes the deterioration and / or weakening of the adhesive material that bears the weight and provides the seal of the ostomy appliance. Usually, such failure can occur unexpectedly quickly, and can only be detected by the user when the failure has become so serious that leakage occurs, thereby requiring immediate replacement of the ostomy appliance and possibly the user's clothes.

[0004] In other instances, the primary factor in adhesive failure is simply a matter of how much time has passed since the base plate of the ostomy appliance was first applied to the skin surface of the user. In addition to the discharge from the stoma itself, the peristomal skin surface also constantly secretes some moisture (e.g., sweat). To mitigate this, the base plate adhesive of the ostomy device most commonly includes a hydrocolloid material that is capable of absorbing high levels of moisture, thereby stabilizing the polymer matrix of the adhesive material and extending the useful life ("wear time") of the base plate. However, eventually the adhesive properties of the base plate are no longer able to support the forces exerted on the base plate by the load of the discharge collection bag, and the appliance must be replaced.

[0005] Because there can be considerable variability in the severity and / or speed with which adhesive failures and potential leaks occur, which variability is at least in part related to a variety of factors, including those described above, a mere indication that a failure or leak is about to occur, or that a failure or leak has already occurred, does not provide a reliable and satisfactory solution to the problem of avoiding unexpected embarrassing and shameful ostomy appliance leaking events. In other words, users of ostomy appliances could greatly benefit from appliance solutions that provide users with better guidance and options about how, and especially how quickly, to respond to the onset of adhesive failure or leaking of the base plate of an appliance. More generally, ostomates and healthcare professionals would appreciate improvements in ostomy devices that reduce or eliminate the occurrence of unexpected leaking events. Summary of the invention

[0006] The object of the present disclosure is to provide a sensor patch for facilitating reliable and / or improved detection of failure risk of ostomy appliances and / or improved detection of leakage risk. The sensor patch may be provided to facilitate detection of failure risk and / or leakage risk with respect to an adhesive base plate of an ostomy appliance.

[0007] The base plate may include: at least a first adhesive material layer, such as a first adhesive layer, which is adapted to attach the base plate to the skin surface of the user; a backing layer, which includes a film material and has a distal surface and a proximal surface; and a central portion, which surrounds a stoma receiving opening extending through the base plate.

[0008] The other purpose of the present disclosure is to provide a method for facilitating the correct attachment of a sensor patch to an ostomy appliance, such as a base plate of an ostomy appliance, such as to improve the reliability of the measurement performed by using the sensor patch. The measurement / monitoring can be performed by an ostomy system, which includes a base plate, a sensor patch, and a monitoring device that can be connected to the sensor patch. Specifically, the purpose is to provide a method for detecting whether a sensor patch for attachment to a base plate has been fully attached to the base plate. According to an embodiment of the present invention, the sensor patch will be attached to the adhesive surface of a base plate, such as a general base plate in the field of ostomy appliances, by a user. However, in order to provide reliable monitoring of the presence of liquid in the interface between the adhesive performance and / or the skin surface and the sensor patch and / or the base plate, it is important for the ostomy system to understand whether the sensor patch has been attached to the base plate with an accuracy that makes the sensor reading reliable. In other words, the purpose of the present invention is to evaluate the attachment of the sensor patch to the base plate, specifically before evaluating the presence of liquid in the interface between the adhesive performance and / or the skin surface and the sensor patch and / or the base plate.

[0009] Thus, a sensor patch for attachment to a base plate of an ostomy appliance is disclosed. The sensor patch is adapted to be attached to the base plate, such as a first layer of the base plate, such as a proximal side of a first adhesive layer of the base plate. The sensor patch comprises a sensor assembly comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor.

[0010] A method for evaluating the attachment of a sensor patch, such as the disclosed sensor patch, to a base plate of an ostomy appliance is also disclosed. The method includes: measuring one or more characteristic quantities; and determining whether the one or more characteristic quantities meet one or more attachment criteria.

[0011] Also disclosed is a monitoring device for evaluating the attachment of a sensor patch, such as the disclosed sensor patch, to a base plate of an ostomy appliance. The monitoring device may be configured to perform the disclosed method and / or at least a portion of the disclosed method. The monitoring device may be configured to: measure one or more characteristic quantities; and determine whether the one or more characteristic quantities meet one or more attachment criteria. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Embodiments of the present disclosure will be described in more detail below with respect to the accompanying drawings. The drawings illustrate one way of implementing the invention and should not be interpreted as limiting other possible embodiments that fall within the scope of the appended claims.

[0013] Figure 1 schematically illustrates an exploded view of an exemplary base plate,

[0014] Figure 2 schematically illustrates an exploded view of an exemplary sensor patch,

[0015] Figure 3 An exemplary electrode configuration is schematically shown,

[0016] Figure 4a and Figure 4b Schematic showing the base plate, sensor patch and the user's skin surface.

[0017] Figure 5 schematically illustrates an exploded view of an exemplary sensor patch,

[0018] Figure 6 schematically illustrates an exploded view of an exemplary sensor patch,

[0019] Figure 7 is a schematic block diagram of an exemplary method, and

[0020] Figure 8 is a schematic block diagram of an exemplary monitoring device. DETAILED DESCRIPTION

[0021] In the following specific embodiments, reference is made to the accompanying drawings, which form a part of the specific embodiments, and wherein the specific embodiments of the present invention can be put into practice by way of illustration. In this regard, with respect to the orientation of the (multiple) accompanying drawings described, directional terms are used, such as "top", "bottom", "front", "back", "leading", "back" etc. Because the parts of the embodiments can be positioned in a plurality of different orientations, directional terms are used for illustrative purposes and are by no means restrictive. It should be understood that other embodiments can be utilized without departing from the scope of the present invention, and structural or logical changes can be made. Therefore the following specific embodiments should not be considered as restrictive, and the scope of the present invention is limited by the appended claims.

[0022] It should be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically stated otherwise.

[0023] Throughout this disclosure, the words "stoma" and "ostomy" are used to represent an opening formed by surgery to bypass the intestinal or urinary tract system of a person. These words are used interchangeably and do not have distinct meanings. The same applies to any words or phrases derived from these words, such as "stoma", "ostomy", etc. In addition, solid and liquid waste coming out of the stoma can be interchangeably referred to as stoma "discharge", "waste" and "fluid". The subject undergoing ostomy surgery can be referred to as a "stoma person" or "ostomy person", in addition, also referred to as a "patient" or "user". However, in some cases, a "user" may also relate to or refer to a health care professional (HCP), such as a surgeon or ostomy care nurse or other person. In these cases, it will be explicitly stated or implied from the context that the "user" is not the "patient" himself or herself.

[0024] In the following, whenever the proximal side of a device or a part of a device is mentioned, reference is made to the side that faces the skin when the ostomy appliance is worn by a user. Likewise, whenever the distal side of a device or a part of a device is mentioned, reference is made to the side that faces away from the skin when the ostomy appliance is worn by a user. In other words, the proximal side is the side that is closest to the user when the appliance is fitted to the user, and the distal side is the opposite side, i.e. the side that is farthest from the user during use.

[0025] The axial direction is defined as the direction of the stoma when the user wears the appliance. Thus, the axial direction is generally perpendicular to the user's skin or abdominal surface.

[0026] The radial direction is defined as being transverse to the axial direction which is transverse to the stoma direction, i.e. "across" the distal / proximal surface of the base plate. In some statements, the words "inner" and "outer" may be used. These qualifiers should generally be understood with reference to the radial direction, so that a reference to an "outer" element means that the element is further away from the central part of the ostomy appliance than the element referred to as "inner". Furthermore, "innermost" should be interpreted as that part of a component forming the center of the component and / or adjacent to the center of the component. Similarly, "outermost" should be interpreted as that part of a component forming the outer edge or outer contour of the component and / or adjacent to the outer edge or outer contour.

[0027] The present disclosure uses the word “substantially” as a modifier of certain features or effects and is intended to simply mean that any deviation is within the tolerance normally expected by those skilled in the relevant art.

[0028] The use of the word "substantially" as a modifier of certain features or effects in this disclosure is intended to simply mean that: for a structural feature, a majority or predominant portion of that feature exhibits the property in question, and for a functional feature or effect: most results involving that property provide that effect, but anomalous results do not provide that effect.

[0029] The word "substantially" is used in this disclosure as a modifier of certain structural and functional features or effects to emphasize what is the most important focus of something or a fact about something (i.e., a feature may have or satisfy multiple effects, but when this disclosure discusses one effect as "substantially" provided, that is the focal and most important effect relevant to this disclosure).

[0030] Throughout this disclosure, the use of the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. does not imply any particular order or importance, but is included merely to identify independent elements. Furthermore, labeling a first element does not imply the existence of a second element, and vice versa.

[0031] The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a base plate of an ostomy appliance, a monitoring device, and optionally one or more accessory devices. In addition, methods related to an ostomy system and devices thereof are disclosed. The accessory device (also referred to as an external device) can be a mobile phone or other handheld device. The accessory device can be a personal electronic device, such as a wearable device, such as a watch or other wrist-worn electronic device. The accessory device can be a docking station. The docking station can be configured to electrically and / or mechanically connect the monitoring device to the docking station. The docking station can be configured to charge the monitoring device and / or be configured to transfer data between the monitoring device and the docking station. The ostomy system can include a server device. The server device can be operated and / or controlled by an ostomy appliance manufacturer and / or a service center.

[0032] The ostomy appliance comprises a base plate and an ostomy bag (also referred to as an ostomy pocket). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urethrostomy appliance. The ostomy appliance may be a two-piece ostomy appliance, i.e., the base plate and the ostomy bag may be releasably connected, e.g., by mechanical and / or adhesive connection, e.g., to allow one base plate to be used (exchanged) with multiple ostomy bags. Further, the two-piece ostomy appliance may facilitate the correct application of the base plate to the skin, e.g., to obtain an improved observation of the stoma area by the user. Alternatively, the ostomy appliance may be a one-piece ostomy appliance, i.e., the base plate and the ostomy bag may be securely attached to each other. The base plate is configured to be connected to the user's stoma and / or the skin around the stoma, such as the peristomal skin area.

[0033] Figure 1 Schematically illustrates an exploded view of an exemplary base plate 4 of an ostomy appliance. Base plate 4 includes a first adhesive layer 200, i.e., a first adhesive material layer. During use, the proximal surface of the first adhesive layer 200 adheres to the peri-stomal region of the user's skin and / or adheres to an additional seal, such as a sealing paste, a sealing tape and / or a sealing ring. Base plate 4 optionally includes a second adhesive layer 202, i.e., a second adhesive material layer, also referred to as an edge adhesive layer. The second adhesive layer 202 can have an adhesive material different from the first adhesive layer 200. Base plate 4 can include a release liner 206, which the user peels off before base plate 4 is applied to the skin. Base plate 4 includes a backing layer 208. The backing layer 208 is a protective layer that protects adhesive layers, such as the first adhesive layer 200 and / or the second adhesive layer 202 from external strains and stresses during use. Furthermore, the backing layer 208 also covers adhesive layers, such as the first adhesive layer 200 and / or the second adhesive layer 202 , so that the adhesive layers 200 , 202 do not adhere to clothing worn over the base plate 4 .

[0034] As illustrated, the base plate 4 is a two-piece ostomy appliance and therefore includes a coupling ring 209 for coupling an ostomy bag to the base plate 4 .

[0035] The first adhesive layer 200 can be made of a first composition. The first composition can include one or more polyisobutylenes and / or styrene-isoprene-styrene. The first composition can include one or more hydrocolloids. The first composition can include one or more water-soluble or water-swellable hydrocolloids. The first composition can be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids.

[0036] The second adhesive layer 202 can be made of a second composition. The second composition can include one or more polyisobutylenes and / or styrene-isoprene-styrene. The second composition can include one or more hydrocolloids. The second composition can include one or more water-soluble or water-swellable hydrocolloids. The second composition can be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids.

[0037] Different ratios of inclusions can change the properties of first adhesive layer 200 and / or second adhesive layer 202. Second adhesive layer 202 and first adhesive layer 200 can have different properties. Second adhesive layer 202 (second composition) and first adhesive layer 200 (first composition) can have different ratios of polyisobutylene, styrene-isoprene-styrene, and / or hydrocolloid. For example, second adhesive layer 202 can provide stronger attachment to skin compared to the attachment to skin provided by first adhesive layer 200. Alternatively or additionally, second adhesive layer 202 can be thinner than first adhesive layer 200. Alternatively or additionally, second adhesive layer 202 can be less absorbent and / or sweat-absorbent than first adhesive layer 200. Alternatively or additionally, second adhesive layer 202 can be less moldable than first adhesive layer 200. Second adhesive layer 202 can provide a second anti-leakage barrier.

[0038] The first adhesive layer 200 includes a distal surface 200A and a proximal surface (not shown). The proximal surface of the first adhesive layer 200 is configured to adhere to the skin of the user, and the distal surface 200A of the first adhesive layer 200 is configured to face away from the skin of the user. The second adhesive layer 202 includes a distal surface 202A and a proximal surface (not shown). The proximal surface of the second adhesive layer 202 is configured to adhere to the skin of the user at least at the edge portion of the second adhesive layer 202, and the distal surface 202A of the second adhesive layer 202 is configured to face away from the skin of the user. The second adhesive layer 202 covers an area larger than the first adhesive layer 200, so that the proximal surface of the second adhesive layer 202 forms a bonding edge around the first adhesive layer 200.

[0039] Release liner 206 includes a distal surface 206A and a proximal surface (not shown). Distal surface 206A of release liner 206 covers the proximal surface of first adhesive layer 200 and covers the proximal surface of second adhesive layer 202 not covered by first adhesive layer 200.

[0040] The backing layer 208 includes a distal surface 208A and a proximal surface (not shown). The distal surface 208A of the backing layer 208 is configured to face away from the user's skin. The proximal surface of the backing layer 208 covers the second adhesive layer 202.

[0041] The base plate 4 comprises a stoma opening 18. Each layer of the base plate 4 may comprise a stoma opening for jointly forming the stoma opening 18 of the base plate. The stoma opening 18 is provided in a central portion of the base plate 4 surrounding the stoma opening 18.

[0042] The stoma opening 18 may be configured to receive a stoma of a user, and / or the stoma opening 18 may be configured to allow discharge from the stoma to pass through the stoma opening into an ostomy bag attached to the base plate 4. For example, the stoma opening may be configured to allow discharge to flow from the proximal side of the base plate 4 to the distal side of the base plate 4. The size and / or shape of the stoma opening may typically be adjusted by the user or a nurse to accommodate the user's stoma before the base plate 4 is applied.

[0043] Figure 2 Schematically illustrates a base plate adapted to be attached to an ostomy appliance, such as Figure 1 Exploded view of an exemplary sensor patch 50 of the base plate shown in FIG. The sensor patch 50 is configured to be positioned between the user's skin and the proximal side of the base plate 4. For example, the sensor patch can be adapted to be attached to the first adhesive layer 200 of the base plate 4.

[0044] The sensor patch 50 is configured to facilitate detection of moisture propagation in an adhesive material that is provided to attach the base plate to the user's skin surface and to detect increased risk of leakage. The sensor patch 50 includes a sensor assembly 204, which includes a plurality of electrodes 216. The plurality of electrodes 216 include a first electrode and a second electrode for forming a first sensor. The electrode 216 includes a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode. Each electrode has a corresponding connection 217 for connecting the electrode 216 to a corresponding terminal element of a monitoring device. The sensor assembly 204 can form a sensor assembly layer.

[0045] The sensor assembly 204 has a distal side 204A and a proximal side 204B. The sensor assembly 204 includes a support layer 214 having a proximal surface 214B. The electrode 216 is disposed, such as formed, on the proximal surface 214B of the support layer 214. For example, the electrode 216 can be positioned on the proximal surface 214B of the support layer 214.

[0046] Electrode assembly 204 may include a masking element 218 having a proximal surface 218B as illustrated and configured to electrically insulate at least a portion of electrode 216 from adjacent layers, such as adhesive sensor layer 52. Masking element 218 covers or overlaps a portion of electrode 216 when viewed in the axial direction.

[0047] The sensor patch 50 is configured to be positioned on the base plate so that the distal side of the sensor patch 50, such as the distal surface 204A of the sensor assembly 204, is coupled to the adhesive proximal surface of the base plate. The sensor patch 50 further includes an optional adhesive sensor layer 52 having a proximal side 52B and a distal side (not visible). The adhesive sensor layer 52 is arranged on the proximal side of the sensor assembly 204. The proximal side 52B of the adhesive sensor layer 52 is configured to adhere to the skin of the user. Therefore, after being applied to the base plate, the combined base plate and sensor patch 50 can form an adhesive proximal surface configured to be applied to the skin surface of the user.

[0048] The adhesive sensor layer 52 can be made of a third composition. The third composition can include one or more polyisobutylenes and / or styrene-isoprene-styrene. The third composition can include one or more hydrocolloids. The third composition can include one or more water-soluble or water-swellable hydrocolloids. The third composition can be a pressure-sensitive adhesive composition suitable for medical purposes, including a rubbery elastomeric substrate and one or more water-soluble or water-swellable hydrocolloids. The third composition can be the same as the first composition. The adhesive sensor layer 50 can be made of the first composition.

[0049] The sensor patch 50 includes a stoma opening 18. Each layer of the sensor patch 50 may include a stoma opening that together forms the stoma opening 18 of the sensor patch 50. The stoma opening 18 of the sensor patch is configured to align with the stoma opening of the base plate, such as to together form the stoma opening of the combined base plate and sensor patch 50. The size and / or shape of the stoma opening of the sensor patch 50 can be adjusted by the user or a nurse to accommodate the user's stoma before applying the sensor patch 50. The size and / or shape of the stoma opening of the sensor patch 50 can be adjusted together with the adjustment of the stoma opening of the base plate, for example, after attaching the sensor patch 50 to the base plate.

[0050] The sensor patch 50 may include a monitor interface (not shown). The monitor interface may be configured to electrically and / or mechanically connect the sensor patch 50, such as the electrodes 216 of the sensor patch 50, to a monitoring device. The monitor interface may be configured to wirelessly connect the sensor patch 50, such as the electrodes 216 of the sensor patch, to a monitoring device. The monitor interface of the sensor patch 50 may be configured to electrically and / or mechanically connect the sensor patch 50 and the monitoring device.

[0051] Figure 3 Schematically illustrates an exemplary sensor assembly, such as Figure 2 An exemplary electrode configuration 220 of the electrodes 216 of the sensor assembly 204 is described. The sensor assembly 204 can include one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven, or more electrodes. In the example shown, the electrode configuration 220 includes a ground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230, and a fifth electrode 232.

[0052] The ground electrode 222 includes a ground connection portion 222A, and the first electrode 224 includes a first connection portion 224A. The second electrode 226 includes a second connection portion 226A, and the third electrode 228 includes a third connection portion 228A. The fourth electrode 230 includes a fourth connection portion 230A, and the fifth electrode 232 includes a fifth connection portion 232A.

[0053] The fourth electrode 230 includes a plurality of fourth sensing portions 230B. The fifth electrode 232 includes a plurality of fifth sensing portions 232B.

[0054] The ground electrode 222 includes a first electrode portion 234 for forming a ground for the first electrode 224. The ground electrode 222 includes a second electrode portion 236 for forming a ground for the second electrode 226. The ground electrode 222 includes a third electrode portion 238 for forming a ground for the third electrode 228. The ground electrode 222 includes a fourth electrode portion 240 for forming a ground for the fourth electrode 230 and the fifth electrode 232. The fourth electrode portion 240 of the ground electrode 222 includes a plurality of ground sensing portions 222B.

[0055] Electrode 216 is conductive and may include one or more of the following: metallic materials (e.g., silver, copper, gold, titanium, aluminum, stainless steel), ceramic materials (e.g., ITO), polymer materials (e.g., PEDOT, PANI, PPy), and carbonaceous materials (e.g., carbon black, carbon nanotubes, carbon fibers, graphene, graphite).

[0056] Two electrodes of the plurality of electrodes 216 may form a sensor. The first electrode and the second electrode form a first sensor. For example, the first electrode 224 and the ground electrode 222 (e.g., the first electrode portion of the ground electrode) may form a first sensor or a first electrode pair. The second electrode 226 and the ground electrode 222 (e.g., the second electrode portion of the ground electrode) may form a second sensor or a second electrode pair. The third electrode 228 and the ground electrode 222 (e.g., the third electrode portion of the ground electrode) may form a third sensor or a third electrode pair. The fourth electrode 230 and the ground electrode 222 (e.g., the fourth electrode portion of the ground electrode) may form a fourth sensor or a fourth electrode pair. The fifth electrode 232 and the ground electrode 222 (e.g., the fifth electrode portion of the ground electrode) may form a fifth sensor or a fifth electrode pair.

[0057] The electrodes may form a ring and / or an open ring. The first electrode 224 may form an open ring. The second electrode 226 may form an open ring and / or the third electrode 228 may form an open ring. The fourth electrode 230 may form an open ring. The fifth electrode 232 may form an open ring. (Multiple) open ring electrodes enable the arrangement of electrodes in few or single electrode layers.

[0058] Figure 4a and Figure 4b The base plate 4, the sensor patch 50 and the user's skin surface 60 are schematically shown. Figure 1 As further described, the bottom plate 4 includes a first adhesive layer 200, a backing layer 208 and a coupling ring 209. Figure 2 As further described, the sensor patch 50 includes a plurality of electrodes 216 , a support layer 214 , a masking element 218 , and an adhesive sensor layer 52 .

[0059] Figure 4aThe schematic diagram shows that the sensor patch 50 is oriented between the base plate 4 and the user's skin surface 60 so that the adhesive sensor layer 52 faces the user's skin surface 60. Therefore, the adhesive sensor layer 52 is adhered to the user's skin surface 60 over the entire area of ​​the first adhesive layer 200 covered by the sensor patch 50.

[0060] like Figure 4a The orientation of the sensor patch 50 relative to the base plate 4 shown is a preferred orientation of the sensor patch that facilitates proper measurement by the electrodes 216 .

[0061] Figure 4b The schematic diagram shows the sensor patch 50 oriented between the base plate 4 and the user's skin surface 60 so that the adhesive sensor layer 52 faces away from the user's skin surface 60 and toward the first adhesive layer 200 of the base plate 4. Thus, the adhesive sensor layer 52 will adhere to the first adhesive layer 200 and no adhesive is provided in the entire area covered by the sensor patch 50.

[0062] like Figure 4b As shown, the orientation of the sensor patch 50 relative to the base plate 4 is a non-preferred orientation of the sensor patch because the orientation may compromise the measurements made by the electrodes 216 because the support layer 214, which may be electrically insulating, is positioned between the electrodes 216 and the user's skin surface 60. In addition, the portion of the adhesive layer that is being measured by the electrodes 216 is shielded from the user's skin surface 60 by the support layer 214. Therefore, the measurement may not reliably detect moisture content in the adhesive and leakage.

[0063] By using electrical measurements of electrodes 216, the orientation of sensor patch 50 relative to base plate 4 can be determined. For example, measurements of resistance and / or capacitance between two or more electrodes 216 can indicate the orientation of sensor patch 50 relative to base plate 4. Figure 4b If the user has incorrectly attached the sensor patch 50, he / she may be notified, and / or if the user Figure 4a He / she may be informed if the sensor patch 50 is correctly attached as shown. Such measurements may be performed after the sensor patch 50 is attached to the base plate 4 and / or after the sensor patch 50 and base plate 4 have been attached to the user's skin.

[0064] Figure 5 An exemplary sensor patch 50 is schematically shown, such as Figure 2 1 is an exploded view of the sensor patch 50. However, Figure 5As shown, the sensor patch 50 includes an additional optional layer, namely a shielding layer 54. The shielding layer 54 has a conductive material, and the shielding layer 54 is arranged on the distal side of the sensor assembly 204. Therefore, when the sensor patch 50 is arranged relative to the base plate as intended, the shielding layer 54 is positioned between the sensor assembly 204 and the first adhesive layer of the base plate. This can further enhance the determination of the orientation of the sensor patch 50 relative to the base plate.

[0065] Figure 6 An exemplary sensor patch 50 is schematically shown, such as Figure 2 and Figure 5 1 is an exploded view of the sensor patch 50. However, Figure 6 As shown, the support layer 214 of the sensor patch 50 includes detection openings 60, such as first detection openings and second detection openings. The detection openings 60 can provide a contact surface between the adhesive surface of the base plate and two or more electrodes of the plurality of electrodes 216 of the sensor patch 50. Thus, the conductivity between two or more electrodes of the plurality of electrodes 216 can be changed by the conductivity of the adhesive of the base plate, thereby providing another or additional option for determining which side of the sensor patch faces the adhesive of the base plate. This can further enhance the determination of the orientation of the sensor patch 50 relative to the base plate.

[0066] like Figure 6 As shown, the exemplary support layer 214 may be Figure 5 The shielding layer 54 is provided in combination with the shielding layer 54 , and the shielding layer 54 may also be provided with a detection opening to allow the adhesive of the bottom plate to contact two or more of the plurality of electrodes 216 .

[0067] The plurality of electrodes 216 may include a designated attachment detection electrode, such as a first attachment detection electrode and / or a second attachment detection electrode. The first attachment detection electrode and / or the second attachment detection electrode may be exposed through the detection opening 60. Alternatively, electrodes forming a sensor, such as a first sensor, such as a first electrode and / or a second electrode may be exposed through the detection opening 60.

[0068] Figure 7 is a schematic block diagram of an exemplary method 1000 for evaluating attachment of a sensor patch to a baseplate, such as the sensor patch and baseplate described with respect to the previous figures.

[0069] The method includes measuring 1002 one or more characteristic quantities and determining 1004 whether the one or more characteristic quantities meet one or more attachment criteria. In an embodiment, the method includes the additional step of attaching the sensor patch to an adhesive surface or backing layer of a base plate. In an embodiment, the sensor patch is attached to the adhesive surface or backing layer of the base plate before measuring the one or more characteristic quantities. Measuring 1002 the one or more characteristic quantities and / or determining 1004 whether the one or more characteristic quantities meet the one or more attachment criteria can be performed before attaching the base plate to the user's skin. Alternatively, measuring 1002 the one or more characteristic quantities and / or determining 1004 whether the one or more characteristic quantities meet the one or more attachment criteria can be performed after attaching the base plate to the user's skin. In an embodiment, measuring 1002 the one or more characteristic quantities and / or determining 1004 whether the one or more characteristic quantities meet the one or more attachment criteria is performed after attaching the base plate to the user's skin, but before measuring characteristics related to the adhesive properties of the sensor patch and / or evaluating whether there is liquid in the interface between the user's skin surface and the sensor patch and / or the base plate. In other words, the assessment of attachment may be performed after the base plate with the sensor patch is attached to the user's skin surface, but before the assessment of adhesive properties and / or the presence of liquid in the interface.

[0070] Thus, in the event that the attachment of the sensor patch to the base plate is inadequate, the risk of leakage is reduced because no determination / conclusion based on the sensor of the sensor patch is made until such attachment is evaluated according to the disclosed method. Conversely, if an inadequate attachment has been determined, the user may be required to replace / remove his / her base plate and sensor patch. In other words, in an embodiment, the sensors for monitoring adhesion properties and / or detecting the presence of liquid (exudate) are not active until the disclosed method for evaluating the attachment of the sensor patch to the base plate has been performed.

[0071] The one or more characteristic quantities measured 1002 may include a first characteristic quantity indicating a capacitance between electrodes, such as between a first electrode and a second electrode. Measuring 1002 the one or more characteristic quantities may include measuring a capacitance and / or a resonant frequency between electrodes, such as between two electrodes, such as between a first electrode and a second electrode. The first electrode and / or the second electrode may be a designated attachment detection electrode, such as Figure 6 The described first attached detection electrode and / or the second attached detection electrode. Alternatively, the first electrode and / or the second electrode may be a first electrode and a second electrode for forming a sensor, such as a first sensor.

[0072] Determining 1004 whether the one or more feature quantities satisfy the one or more attachment criteria may include comparing the first feature quantity to a first feature threshold. In order for the one or more feature quantities to satisfy the one or more attachment criteria, the first feature quantity may be required to be above the first feature threshold. Alternatively or additionally, in order for the one or more feature quantities to satisfy the one or more attachment criteria, the first feature quantity may be required to be below a first secondary feature threshold. Alternatively or additionally, in order for the one or more feature quantities to satisfy the one or more attachment criteria, the first feature quantity may be required to be below the first feature threshold.

[0073] The one or more characteristic quantities measured 1002 may include a second characteristic quantity indicating the resistance between electrodes, such as between a first electrode and a second electrode. Measuring 1002 the one or more characteristic quantities may include measuring the resistance between electrodes, such as between two electrodes, such as between a first electrode and a second electrode. The first electrode and / or the second electrode may be a designated attachment detection electrode, such as Figure 6 The described first attached detection electrode and / or the second attached detection electrode. Alternatively, the first electrode and / or the second electrode may be a first electrode and a second electrode for forming a sensor, such as a first sensor.

[0074] Determining 1004 whether the one or more feature quantities satisfy the one or more attachment criteria may include comparing the second feature quantity to a second feature threshold. In order for the one or more feature quantities to satisfy the one or more attachment criteria, the second feature quantity may be required to be above the second feature threshold. Alternatively or additionally, in order for the one or more feature quantities to satisfy the one or more attachment criteria, the second feature quantity may be required to be below a second secondary feature threshold. Alternatively or additionally, in order for the one or more feature quantities to satisfy the one or more attachment criteria, the second feature quantity may be required to be below the second feature threshold.

[0075] Determining 1004 whether the one or more feature quantities satisfy the one or more attachment criteria may include comparing a third feature quantity to a third feature threshold. The third feature quantity may be based on the first feature quantity and the second feature quantity. For example, the third feature quantity may be an algebraic expression including the first feature quantity and the second feature quantity.

[0076] Determining 1004 whether the one or more feature quantities satisfy the one or more attachment criteria may include comparing the third feature quantity to a third feature threshold. In order for the one or more feature quantities to satisfy the one or more attachment criteria, the third feature quantity may be required to be above the third feature threshold. Alternatively or additionally, in order for the one or more feature quantities to satisfy the one or more attachment criteria, the third feature quantity may be required to be below a third secondary feature threshold. Alternatively or additionally, in order for the one or more feature quantities to satisfy the one or more attachment criteria, the third feature quantity may be required to be below the third feature threshold.

[0077] Method 1000 optionally includes issuing 1006 a fault signal indicating that the sensor patch is not adequately attached based on the one or more characteristic quantities not satisfying the one or more attachment criteria.

[0078] Method 1000 optionally includes issuing 1008 a success signal indicating that the sensor patch is sufficiently attached based on the one or more characteristic quantities satisfying the one or more attachment criteria.

[0079] The sensor patch may include a monitor interface configured to connect the sensor assembly to a monitoring device. Method 1000 may include, for example, connecting 1010 a monitoring device to the sensor assembly before measuring 1002 one or more characteristic quantities. Measuring 1002 the one or more characteristic quantities and / or determining 1004 whether the one or more characteristic quantities meet the one or more attachment criteria may be performed by the monitoring device. Sending 1006 a fault signal may be performed by the monitoring device and / or an auxiliary device coupled to the monitoring device. Sending 1008 a success signal may be performed by the monitoring device and / or an auxiliary device coupled to the monitoring device. The auxiliary device may be wirelessly coupled to the monitoring device. The auxiliary device may be a mobile phone (such as a smart phone), a smart watch, a tablet computer, a computer, etc. that is capable of issuing and / or displaying notifications.

[0080] Figure 8 is a schematic block diagram of an exemplary monitoring device 6. The monitoring device 6 may include a monitoring device housing 100, a processor 101, and one or more interfaces. The one or more interfaces may include a first interface 102 and / or a second interface 104. The monitoring device 6 may include a memory 106 for storing ostomy data and / or parameter data based on the ostomy data. The memory 106 may be connected to the processor 101 and / or the first interface 102.

[0081] The first interface 102 can be configured as an appliance interface for electrically and / or mechanically connecting the monitoring device 6 to a sensor patch as described with respect to the previous figures. The first interface 102 can include a plurality of terminals to form an electrical connection with corresponding terminals of the sensor patch. The first interface 102 can include a ground terminal 108, a first terminal 110, a second terminal 112, and a third terminal 114. The first interface 102 optionally includes a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitoring device 6 can include a coupling portion 120 for forming a mechanical connection, such as a releasable connection, between the monitoring device and the sensor patch.

[0082] The monitoring device 6 may include a power supply unit 121 for powering the monitoring device and its active components, ie the power supply unit 121 may be connected to the processor 101, the first interface 102, the second interface 104 and / or the memory 106. The power supply unit may include a battery and a charging circuit.

[0083] The second interface 104 of the monitoring device can be configured as an accessory interface for connecting the monitoring device 6 to one or more accessory devices, such as a mobile phone or another suitable accessory device. The second interface 104 can include, for example, an antenna 122 and a wireless transceiver 124 configured for wireless communication with the accessory device(s). Optionally, the second interface 104 includes a speaker 126 and / or a tactile feedback element 128 for providing corresponding audio signals and / or tactile feedback to the user.

[0084] The monitoring device 6 may comprise a sensor unit 140 connected to the processor 101. The sensor unit 140 may comprise a temperature sensor for feeding temperature data to the processor and a G-sensor or accelerometer for feeding acceleration data to the processor 101.

[0085] The monitoring device 6, such as the processor 101 of the monitoring device, may be configured to evaluate the attachment of the sensor patch to the base plate. For example, the monitoring device 6, such as the processor 101 of the monitoring device, may be configured to perform the following steps: Figure 7 A method and / or a part of a method is described.

[0086] Although specific embodiments have been shown and described herein, it will be appreciated by those skilled in the art that a variety of alternative and / or equivalent embodiments may be substituted for the specific embodiments shown and described without departing from the scope of the invention. This application is intended to cover any changes or variations of the body side members of ostomy appliances as discussed herein. Therefore, the present invention is intended to be limited only by the claims and their equivalents.

Claims

1. A method for evaluating the attachment of a sensor patch to a base plate of an ostomy appliance, wherein: The bottom plate comprises: - at least a first layer of adhesive material adapted to attach the base plate to a skin surface of a user; - a backing layer comprising a film material and having a distal surface and a proximal surface; and - a central portion surrounding a stoma receiving opening extending through the base plate, The sensor patch is adapted to be attached to the first adhesive material layer of the base plate, and wherein the sensor patch comprises: - a sensor assembly comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor, wherein the sensor patch is configured to monitor the presence of liquid between the skin surface and the base plate, The method comprises: - measuring one or more characteristic quantities of a sensor patch, the one or more characteristic quantities comprising a first characteristic quantity indicative of a capacitance between the first electrode and the second electrode of the sensor patch; and - determining whether the one or more characteristic quantities satisfy one or more attachment criteria in order to assess the attachment of the sensor patch to the base plate.

2. The method according to claim 1, wherein: Determining whether the one or more feature quantities satisfy the one or more attachment criteria includes comparing the first feature quantity to a first feature threshold.

3. The method according to claim 2, wherein: The one or more feature quantities satisfying the one or more attachment criteria requires that the first feature quantity be above the first feature threshold.

4. The method according to claim 2, wherein: The one or more feature quantities satisfying the one or more attachment criteria requires that the first feature quantity be below the first feature threshold.

5. The method according to any one of claims 1 to 4, wherein: The one or more feature quantities include a second feature quantity indicating resistance between the first electrode and the second electrode.

6. The method according to claim 5, wherein: Determining whether the one or more feature quantities satisfy the one or more attachment criteria includes comparing the second feature quantity to a second feature threshold.

7. The method according to claim 6, wherein: If the second feature quantity is above the second feature threshold, the one or more feature quantities satisfy the one or more attachment criteria.

8. The method according to claim 6, wherein: If the second feature quantity is below the second feature threshold, the one or more feature quantities satisfy the one or more attachment criteria.

9. The method according to claim 5, wherein: Determining whether the one or more feature quantities satisfy the one or more attachment criteria includes comparing a third feature quantity to a third feature threshold, wherein the third feature quantity is based on the first feature quantity and the second feature quantity.

10. The method according to claim 9, wherein: If the third feature quantity is above the third feature threshold, the one or more feature quantities satisfy the one or more attachment criteria.

11. The method according to claim 9, wherein: If the third feature quantity is below the third feature threshold, the one or more feature quantities satisfy the one or more attachment criteria.

12. The method of any one of claims 1-4, comprising issuing a fault signal indicating that the sensor patch is not adequately attached based on the one or more characteristic quantities not satisfying the one or more attachment criteria.

13. The method of any one of claims 1-4, comprising issuing a success signal indicating that the sensor patch is sufficiently attached based on the one or more characteristic quantities satisfying the one or more attachment criteria.

14. The method according to any one of claims 1 to 4, wherein: Measuring the one or more characteristic quantities and determining whether the one or more characteristic quantities meet the one or more attachment criteria are performed prior to attaching the base plate to the user's skin.

15. The method according to any one of claims 1 to 4, wherein: The sensor patch comprises a monitor interface configured for connecting the sensor assembly to a monitoring device, and wherein the method comprises connecting the monitoring device to the sensor assembly prior to measuring the one or more characteristic quantities.

16. The method according to claim 15, wherein: Measuring the one or more characteristic quantities and determining whether the one or more characteristic quantities meet the one or more attachment criteria are performed by the monitoring device.

17. The method according to claim 12, wherein: The fault signaling is performed by a monitoring device connected to the sensor assembly.

18. The method according to claim 12, wherein: The fault signaling is performed by an auxiliary device coupled to a monitoring device connected to the sensor assembly.

19. The method according to claim 13, wherein: The sending of the success signal is performed by a monitoring device connected to the sensor assembly.

20. The method according to claim 13, wherein: The issuing of the success signal is performed by an auxiliary device coupled to a monitoring device connected to the sensor assembly.

21. The method according to any one of claims 1 to 4, wherein: The sensor patch includes an adhesive sensor layer disposed on a proximal side of the sensor assembly.

22. The method according to any one of claims 1 to 4, wherein: The sensor patch includes a shielding layer of conductive material disposed on a distal side of the sensor assembly.

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