Patent Grant
11612508
The present disclosure relates to an ostomy system, devices thereof, method of manufacturing and method for monitoring an ostomy appliance. The ostomy appliance system comprises an ostomy appliance and an ostomy monitor device. In particular, the present disclosure relates to leakage classification and/or detection and monitoring of the operation of an ostomy appliance.
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.
Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.
Throughout this disclosure, the words “stoma” and “ostomy” are used to denote a surgically created opening bypassing the intestines or urinary tract system of a person. The words are used interchangeably, and no differentiated meaning is intended. The same applies for any words or phrases derived from these, e.g. “stomal”, “ostomies” etc. Also, the solid and liquid wastes emanating from the stoma may be referred to as both stomal “output,” “waste(s),” and “fluids” interchangeably. A subject having undergone ostomy surgery may be referred to as “ostomist” or “ostomate”—moreover, also as “patient” or “user”. However, in some cases “user” may also relate or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse or others. In those cases, it will either be explicitly stated, or be implicit from the context that the “user” is not the “patient” him- or herself.
In the following, whenever referring to proximal side or surface of a layer, an element, a device or part of a device, the referral is to the skin-facing side or surface, when a user wears the ostomy appliance. Likewise, whenever referring to the distal side or surface of a layer, an element, a device or part of a device, the referral is to the side or surface facing away from the skin, when a user wears the ostomy appliance. In other words, the proximal side or surface is the side or surface closest to the user, when the appliance is fitted on a user and the distal side is the opposite side or surface—the side or surface furthest away from the user in use.
The axial direction is defined as the direction of the stoma, when a user wears the appliance. Thus, the axial direction is generally perpendicular to the skin or abdominal surface of the user.
The radial direction is defined as perpendicular to the axial direction. In some sentences, the words “inner” and “outer” may be used. These qualifiers should generally be perceived with respect to the radial direction, such that a reference to an “outer” element means that the element is farther away from a centre portion of the ostomy appliance than an element referenced as “inner”. In addition, “innermost” should be interpreted as the portion of a component forming a centre of the component and/or being adjacent to the centre of the component. In analogy, “outermost” should be interpreted as a portion of a component forming an outer edge or outer contour of a component and/or being adjacent to that outer edge or outer contour.
The use of the word “substantially” as a qualifier to certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.
The use of the word “generally” as a qualifier to certain features or effects in this disclosure is intended to simply mean—for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and—for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect, but that exceptionally outcomes do no provide the effect.
The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices. Further, methods related to the ostomy system and devices thereof are disclosed. An accessory device (also referred to as an external device) may be a mobile phone or other handheld device. An accessory device may be a personal electronic device, e.g. a wearable, such as a watch or other wrist-worn electronic device. An accessory device may be a docking station. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station. The docking station may be configured for charging the monitor device and/or configured for transferring data between the monitor device and the docking station. The ostomy system may comprise a server device. The server device may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre.
The present disclosure provides an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices which either alone or together facilitate reliable determination of the nature, severity and rapidness of moisture propagation in the adhesive material provided for attaching the base plate to the skin surface of a user. Depending on the nature of the pattern of moisture propagation in the adhesive, the ostomy system and devices thereof enable providing information to the user about the type of failure, and in turn enable providing an indication to the user of the severity and thus the remaining time frame for replacing the ostomy appliance without experiencing severe leakage and/or skin damage.
The ostomy appliance comprises a base plate and an ostomy pouch (also referred to as an ostomy bag). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urostomy appliance. The ostomy appliance may be a two-part ostomy appliance, i.e. the base plate and the ostomy pouch may be releasably coupled e.g. with a mechanical and/or an adhesive coupling, e.g. to allow that a plurality of ostomy pouches can be utilized (exchanged) with one base plate. Further, a two-part ostomy appliance may facilitate correct application of the base plate to skin, e.g. to an improved user sight of the stomal region. The ostomy appliance may be a one-part ostomy appliance, i.e. the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured for coupling to a user's stoma and/or skin surrounding the stoma, such as a peristomal skin area.
The ostomy appliance includes a base plate, such as a monolithic, one-piece base plate, e.g. integrated with a sensor assembly part, or a base plate and a separate sensor assembly part, such as a sensor assembly part to be subsequently applied to a base plate. For example, to allow an arbitrary base plate, such as a conventional base plate, to achieve the features as described herein. Features as described with respect to the base plate herein may be provided by a sensor assembly part to be applied to a base plate, e.g. by the user. A sensor assembly part may be adapted to adhere to an ostomy plate.
A disclosed method of attaching a base plate to a user's stoma and/or skin surrounding the stoma, such as the peristomal skin area, may comprise attaching a sensor assembly part to a base plate and attaching the base plate, e.g. together with the attached sensor assembly part, to the user's stoma and/or skin surrounding the stoma, such as the peristomal skin area. Alternatively, the method of attaching the base plate to the user's stoma and/or skin surrounding the stoma may comprise attaching the sensor assembly part to the user's stoma and/or skin surrounding the stoma and attaching the base plate to the user's stoma and/or skin surrounding the stoma above the attached sensor assembly part.
The base plate and/or the sensor assembly part may comprise a first adhesive layer, also denoted center adhesive layer. During use, the first adhesive layer adheres to the user's skin (peristomal area) and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. Thus, the first adhesive layer may be configured for attachment of the base plate and/or the sensor assembly part to the skin surface of a user. The first adhesive layer may have a stomal opening, such as a first adhesive stomal opening, with a center point.
The first adhesive layer may be made of a first composition. The first composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The first composition may comprise one or more hydrocolloids. The first composition may comprise one or more water soluble or water swellable hydrocolloids.
The first composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base and one or more water soluble or water swellable hydrocolloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutenes and the absorbing properties of the hydrocolloids renders the first composition suitable for use in ostomy appliances. The styrene copolymer may for example be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block-copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutenes are preferably present in an amount of from 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation in the first composition are selected from naturally occurring hydrocolloids, semisynthetic hydrocolloids and synthetic hydrocolloids.
The first composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC). The first composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.
The first adhesive layer may have a plurality of sensor point openings. A sensor point opening of the first adhesive layer is optionally configured to overlap a part of an electrode, e.g. to form a sensor point.
The sensor point openings of the first adhesive layer may comprise primary sensor point openings. The primary sensor point openings may comprise one or more primary first sensor point openings and one or more primary second sensor point openings, the primary first sensor point openings configured to overlap parts of an electrode and the primary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the primary first sensor point openings.
The sensor point openings of the first adhesive layer may comprise secondary sensor point openings. The secondary sensor point openings may comprise one or more secondary first sensor point openings and one or more secondary second sensor point openings, the secondary first sensor point openings configured to overlap parts of an electrode and the secondary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the secondary first sensor point openings.
The sensor point openings of the first adhesive layer may comprise tertiary sensor point openings. The tertiary sensor point openings may comprise one or more tertiary first sensor point openings and one or more tertiary second sensor point openings, the tertiary first sensor point openings configured to overlap parts of an electrode and the tertiary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the tertiary first sensor point openings.
The first adhesive layer may have a substantially uniform thickness. The first adhesive layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.
The first adhesive layer may have a primary thickness in a primary part of the first adhesive layer, e.g. in a primary region within a primary radial distance or in a primary radial distance range from the center point of the stomal opening. The primary thickness may be in the range from 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.
The first adhesive layer may have a secondary thickness in a secondary part of the first adhesive layer, e.g. in a secondary region outside a secondary radial distance or in a secondary radial distance range from the center point of the stomal opening. The secondary thickness may be in the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.
The base plate and/or the sensor assembly part may comprise a second layer. The second layer may be a second adhesive layer, also denoted rim adhesive layer. The second layer may have a second radial extension that is larger than a first radial extension of the first adhesive layer at least in a first angular range of the base plate and/or the sensor assembly part. Accordingly, a part of a proximal surface of the second layer may be configured for attachment to the skin surface of a user. The part of a proximal surface of the second layer configured for attachment to the skin surface of a user is also denoted the skin attachment surface of the second adhesive layer. The second layer may have a stomal opening, such as a second layer stomal opening and/or a second adhesive stomal opening, with a center point.
The second adhesive layer may be made of a second composition. The second composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The second composition may comprise one or more hydrocolloids. The second composition may comprise one or more water soluble or water swellable hydrocolloids.
The second composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base and one or more water soluble or water swellable hydrocolloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutenes and the absorbing properties of the hydrocolloids renders the second composition suitable for use in ostomy appliances. The styrene copolymer may for example be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block-copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutenes are preferably present in an amount of from 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PI B). Suitable hydrocolloids for incorporation in the second composition are selected from naturally occurring hydrocolloids, semisynthetic hydrocolloids and synthetic hydrocolloids. The second composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC). The second composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.
Different ratio of contents may change properties of the first and/or second adhesive layers. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutenes, styrene-isoprene-styrene, and/or hydrocolloids. For example, the second adhesive layer may provide a stronger attachment to the skin compared to attachment to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less water and/or sweat absorbing than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less mouldable than the first adhesive layer. The second adhesive layer may provide a second barrier against leakage.
The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.
The base plate and/or the sensor assembly part may comprise one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven or more electrodes. The sensor assembly part may be applied to the base plate, such as to provide the base plate with the one or more electrodes.
The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the second adhesive layer. The electrodes may be arranged in an electrode assembly, e.g. an electrode layer. An electrode comprises a connection part for connecting the electrodes to other components and/or interface terminals. An electrode may comprise one or more conductor parts and/or one or more sensing parts. The electrode assembly may be arranged between the first adhesive layer and the second adhesive layer. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a first electrode, a second electrode and optionally a third electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a fourth electrode and/or a fifth electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, optionally comprises a sixth electrode. The base plate and/or the sensor assembly part, e.g. the electrode assembly, may comprise a ground electrode. The ground electrode may comprise a first electrode part. The first electrode part of the ground electrode may form a ground for the first electrode. The ground electrode may comprise a second electrode part. The second electrode part of the ground electrode may form a ground for the second electrode. The ground electrode may comprise a third electrode part. The third electrode part of the ground electrode may form a ground for the third electrode. The ground electrode may comprise a fourth electrode part. The fourth electrode part of the ground electrode may form a ground for the fourth electrode and/or the fifth electrode.
The ground electrode or electrode parts of the ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes of the electrode assembly. The ground electrode may also be denoted reference electrode.
The electrodes are electrically conductive and may comprise one or more of metallic (e.g. silver, copper, gold, titanium, aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbon fibre, graphene, graphite) materials.
Two electrodes of the electrode assembly may form a sensor. The first electrode and the ground electrode (e.g. first electrode part of the ground electrode) may form a first sensor or first electrode pair. The second electrode and the ground electrode (e.g. second electrode part of the ground electrode) may form a second sensor or second electrode pair. The third electrode and the ground electrode (e.g. third electrode part of the ground electrode) may form a third sensor or third electrode pair. The fourth electrode and the ground electrode (e.g. fourth electrode part of the ground electrode) may form a fourth sensor or fourth electrode pair. The fifth electrode and the ground electrode (e.g. fifth electrode part of the ground electrode) may form a fifth sensor or fifth electrode pair.
The first electrode may form an open loop. The second electrode may form an open loop and/or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open loop electrode(s) enables electrode arrangement in few or a single electrode layer.
The electrode assembly may comprise a support layer, also denoted a support film. One or more electrodes may be formed, e.g. printed, on the proximal side of the support layer. One or more electrodes may be formed, e.g. printed, on the distal side of the support layer. The electrode assembly, such as the support layer of the electrode assembly, may have a stomal opening, such as an electrode assembly stomal opening and/or a support layer stomal opening, with a center point.
The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates and/or sensor assembly parts, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.
Exemplary thermoplastic elastomers of the support layer are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).
The base plate and/or the sensor assembly part, such as the electrode assembly may comprise a masking element configured to insulate at least parts of the electrodes from the first adhesive layer of the base plate and/or of the sensor assembly part. The masking element may comprise one or more, such as a plurality of, sensor point openings. The sensor point openings may comprise primary sensor point openings and/or secondary sensor point openings. The sensor point openings may comprise tertiary sensor point opening(s). The sensor point openings may comprise quaternary sensor point opening(s) A sensor point opening of the masking element overlaps at least one electrode of the electrode assembly when seen in the axial direction, e.g. to form a sensor point. For example, a primary sensor point opening may overlap a part of the ground electrode and/or a part of the fourth electrode. A secondary sensor point opening may overlap a part of the fourth electrode and/or a part of the fifth electrode. A tertiary sensor point opening may overlap a part of the fifth electrode and/or a part of the ground electrode.
The masking element may comprise one or more, such as a plurality of, terminal openings. The masking element may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates and/or sensor assembly parts, the masking element is made of or comprises thermoplastic polyurethane (TPU). In one or more exemplary base plates and/or sensor assembly parts, the masking element is made of or comprises polyester. The masking element material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.
Exemplary thermoplastic elastomers of the masking element are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).
The base plate and/or the sensor assembly part may comprise a first intermediate element. The first intermediate element may be arranged between the electrodes/electrode layer and the first adhesive layer and/or between the second layer and the first adhesive layer. The first intermediate layer may be made of an insulating material.
The base plate and/or the sensor assembly part may comprise a release liner. The release liner is a protective layer that protects adhesive layer(s) during transport and storage and is peeled off by the user prior to applying the base plate on the skin. The release liner may have a stomal opening, such as a release liner stomal opening, with a center point.
The base plate and/or the sensor assembly part may comprise a top layer. The top layer is a protective layer protecting the adhesive layer(s) from external strains and stress when the user wears the ostomy appliance. The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the top layer. The top layer may have a stomal opening, such as a top layer stomal opening, with a center point. The top layer may have a thickness in the range from 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm.
The base plate and/or the sensor assembly part may comprise a monitor interface. The monitor interface may be configured for electrically and/or mechanically connecting the ostomy appliance (base plate and/or sensor assembly part) to the monitor device. The monitor interface may be configured for wirelessly connecting the ostomy appliance (base plate and/or sensor assembly part) to the monitor device. Thus, the monitor interface of the base plate and/or the sensor assembly part may be configured to electrically and/or mechanically couple the ostomy appliance and the monitor device.
The monitor interface of the base plate and/or of the sensor assembly part may comprise, e.g. as part of a first connector of the monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate and/or the sensor assembly part. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate and/or the sensor assembly part.
The monitor interface of the base plate and/or of the sensor assembly part may comprise, e.g. as part of a first connector of the monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The monitor interface may comprise a ground terminal element forming a ground terminal. The monitor interface may comprise a first terminal element forming a first terminal, a second terminal element forming a second terminal and optionally a third terminal element forming a third terminal. The monitor interface may comprise a fourth terminal element forming a fourth terminal and/or a fifth terminal element forming a fifth terminal. The monitor interface optionally comprises a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact respective electrodes of the base plate and/or of the sensor assembly part, such as of the electrode assembly. The first intermediate element may be arranged between the terminal elements and the first adhesive layer. The first intermediate element may cover or overlap terminal element(s) of the base plate and/or of the sensor assembly part when seen in the axial direction. Thus, the first adhesive layer may be protected or experience more evenly distributed mechanical stress from the terminal elements of the base plate and/or of the sensor assembly part, in turn reducing the risk of terminal elements penetrating or otherwise damaging the first adhesive layer. The first intermediate element may protect or mechanically and/or electrically shield the first adhesive layer from the terminal elements of the base plate and/or of the sensor assembly part.
A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may comprise a distal end and a proximal end. A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may comprise a distal part, a centre part, and/or a proximal part. The distal part may be between the distal end and the centre part. The proximal part may be between the proximal end and the centre part. A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may be gold plated copper.
The base plate may comprise a coupling ring or other coupling member for coupling an ostomy pouch to the base plate (two-part ostomy appliance). The center point may be defined as a center of the coupling ring.
The base plate and/or the sensor assembly part may have a stomal opening, e.g. with a center point. The stomal opening of the base plate and/or the sensor assembly part may be formed collectively of stomal opening(s) of the layers of the base plate and/or the sensor assembly part, such as of the top layer, the first adhesive layer, the second layer and/or the sensor assembly part. The stomal opening(s) of the layers of the base plate and/or the sensor assembly part, such as of the top layer, the first adhesive layer, the second layer and/or the sensor assembly part may be aligned to form the stomal opening of the base plate and/or the sensor assembly part. The stomal opening may be a through-going passage of the base plate and/or the sensor assembly part. The stomal opening may be arranged substantially in the center of the base plate and/or the sensor assembly part. The stomal opening(s) of the layers of the base plate and/or the sensor assembly part may be arranged substantially in the center of the respective layer. The stomal opening may be configured to receive a stoma of the user and/or the stomal opening may be configured to allow output from the stoma to pass through the stomal opening an into an ostomy pouch attached to the base plate. For example, the stomal opening may be configured to allow passage of output from a proximal side of the base plate and/or sensor assembly part to a distal side of the base plate and/or sensor assembly part. The size and/or shape of the stomal opening may typically be adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma. In one or more exemplary base plates and/or sensor assembly parts, the user forms the stomal opening during preparation of the base plate and/or the sensor assembly part for application.
The monitor device comprises a processor and one or more interfaces, such as a first interface and/or a second interface. The monitor device may comprise a memory for storing ostomy data.
In one or more exemplary monitor devices, the processor is configured to apply a processing scheme, the first interface is connected to the processor and the memory, and the first interface is configured for collecting ostomy data from the base plate and/or the sensor assembly part coupled to the first interface. The ostomy data may comprise one or more, such as all, of first ostomy data from a first electrode pair of the base plate and/or the sensor assembly part, second ostomy data from a second electrode pair of the base plate and/or the sensor assembly part, and third ostomy data from a third electrode pair of the base plate and/or the sensor assembly part. A second interface is connected to the processor. To apply a processing scheme may comprise one or more of obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; and obtain third parameter data based on the third ostomy data. To apply a processing scheme may comprise determine an operating state of the base plate of the ostomy appliance based on one or more, such as all, of the first parameter data, the second parameter data and the third parameter data. The operating state may be indicative of a degree of radial erosion of the base plate, such as of the first adhesive layer, and/or an acute leakage risk for the ostomy appliance. The monitor device is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and/or in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.
In one or more exemplary monitor devices, the first operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate and/or of the sensor assembly part has experienced a first degree of radial erosion, e.g. the first adhesive layer is eroded to a first radial distance of the first electrode pair but not to a second radial distance of the second electrode pair.
In one or more exemplary monitor devices, the second operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate and/or of the sensor assembly part has experienced a second degree of radial erosion, e.g. the first adhesive layer is eroded to the second radial distance of the second electrode pair but not to a third radial distance of the third electrode pair.
To obtain first parameter data based on the first ostomy data may comprise determining one or more first parameters based on the first ostomy data. To obtain second parameter data based on the second ostomy data may comprise determining one or more second parameters based on the second ostomy data. To obtain third parameter data based on the third ostomy data may comprise determining one or more third parameters based on the third ostomy data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more first parameters, such as first primary parameter and/or first secondary parameter of first parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more second parameters, such as second primary parameter and/or second secondary parameter of the second parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more third parameters, such as third primary parameter and/or third secondary parameter of the third parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more fourth parameters, such as fourth primary parameter and/or fourth secondary parameter of the fourth parameter data.
The first parameter data, the second parameter data, and the third parameter data may be indicative of resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.
The first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.
In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a first criteria set based on the first parameter data and/or the second parameter data, wherein the operating state is determined to be the first operating state if the first criteria set is satisfied. The first criteria set may comprise one or more first criteria based on one or more of first parameter data, second parameter data and third parameter data. The first criteria set may comprise a first primary criterion based on the first parameter data. The first criteria set may comprise a first secondary criterion based on the second parameter data. The first criteria set may comprise a first tertiary criterion based on the third parameter data.
In one or more exemplary monitor devices, to determine an operating state of the base plate may be based on a first threshold set comprising one or a plurality of first threshold values. The first threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the first criteria set. The first threshold set may comprise a first primary threshold value. The first threshold set may comprise a first secondary threshold value. The first threshold set may comprise a first tertiary threshold value.
The first criteria set may be given by
The first primary parameter P_1_1 may be indicative of the resistance between the first electrode pair (first electrode and first electrode part of the ground electrode) of the base plate and/or the sensor assembly part.
The second primary parameter may be indicative of the resistance between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate and/or the sensor assembly part.
The third primary parameter may be indicative of resistance between the third electrode pair (third electrode and third electrode part of the ground electrode) of the base plate and/or the sensor assembly part.
In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second criteria set based on the second parameter data and/or the third parameter data, wherein the operating state is determined to be the second operating state if the second criteria set is satisfied. The second criteria set may be based on the first parameter data.
The second criteria set may comprise one or more second criteria based on one or more of first parameter data, second parameter data and third parameter data. The second criteria set may comprise a second primary criterion based on the first parameter data. The second criteria set may comprise a second secondary criterion based on the second parameter data. The second criteria set may comprise a second tertiary criterion based on the third parameter data.
In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second threshold set comprising one or a plurality of second threshold values. The second threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the second criteria set. The second threshold set may comprise a second primary threshold value. The second threshold set may comprise a second secondary threshold value. The second threshold set may comprise a second tertiary threshold value.
The second criteria set may be given by
In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a default criteria set based on the first parameter data, wherein the operating state is determined to be the default operating state if the default criteria set is satisfied, and in accordance with a determination that the operating state is the default operating state, transmit a default monitor signal comprising monitor data indicative of the default operating state of the ostomy appliance.
The default criteria set may be given by
In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a third criteria set based on the third parameter data, wherein the operating state is determined to be the third operating state if the third criteria set is satisfied, and in accordance with a determination that the operating state is the third operating state, transmit a third monitor signal comprising monitor data indicative of the third operating state of the ostomy appliance.
In one or more exemplary monitor devices, the third operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate and/or of the sensor assembly part has experienced a third degree of radial erosion, e.g. the first adhesive layer is eroded to the third radial distance of the third electrode pair.
The third criteria set may be given by
In one or more exemplary monitor devices, the ostomy data comprises fourth ostomy data from a fourth electrode pair of the base plate and/or of the sensor assembly part. To apply a processing scheme may comprise to obtain fourth parameter data based on the fourth ostomy data, and determine an operating state of the base plate of the ostomy appliance based on the fourth parameter data. The monitor device may be configured to, in accordance with a determination that the operating state is a fourth operating state, transmit a fourth monitor signal comprising monitor data indicative of the fourth operating state of the ostomy appliance.
In one or more exemplary monitor devices, the fourth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as output, between the distal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a high risk of leakage from the ostomy appliance in the fourth operating state.
The fourth criteria set may be given by
The monitor device comprises a monitor device housing optionally made of a plastic material. The monitor device housing may be an elongate housing having a first end and a second end. The monitor device housing may have a length or maximum extension along a longitudinal axis in the range from 1 cm to 15 cm. The monitor device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.
The monitor device comprises a first interface. The first interface may be configured as an appliance interface for electrically and/or mechanically connecting the monitor device to the ostomy appliance. Thus, the appliance interface is configured to electrically and/or mechanically couple the monitor device and the ostomy appliance. The first interface may be configured as an accessory device interface for electrically and//or mechanically connecting the monitor device to an accessory device, such as a docking station. The first interface may be configured for coupling to a docking station of the ostomy system, e.g. for charging the monitor device and/or for data transfer between the monitor device and the docking station.
The first interface of the monitor device may comprise a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals and/or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured for forming electrical connections with an accessory device, e.g. with respective terminals of a docking station. The first interface may comprise a ground terminal. The first interface may comprise a first terminal, a second terminal and optionally a third terminal. The first interface may comprise a fourth terminal and/or a fifth terminal. The first interface optionally comprises a sixth terminal. In one or more exemplary monitor devices, the first interface has M terminals, wherein M is an integer in the range from 4 to 8.
The first interface of the monitor device may comprise a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate and/or the sensor assembly part. The coupling part and the terminals of the first interface form (at least part of) a first connector of the monitor device.
The monitor device comprises a power unit for powering the monitor device. The power unit may comprise a battery. The power unit may comprise charging circuitry connected to the battery and terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery.
The monitor device may comprise a sensor unit with one or more sensor. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise an accelerometer for sensing acceleration and provision of acceleration data to the processor. The sensor unit may comprise a temperature sensor for provision of temperature data to the processor.
The monitor device comprises a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting, e.g. wirelessly connecting, the monitor device to one or more accessory devices. The second interface may comprise an antenna and a wireless transceiver, e.g. configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e. the wireless transceiver may be configured for wireless communication according to Bluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The second interface optionally comprises a loudspeaker and/or a haptic feedback element for provision of an audio signal and/or haptic feedback to the user, respectively.
In one or more exemplary ostomy systems, the monitor device forms an integrated part of the ostomy appliance, e.g. the monitor device may form an integrated part of a base plate and/or a sensor assembly part of the ostomy appliance.
The ostomy system may comprise a docking station forming an accessory device of the ostomy system. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station.
The docking station may comprise a docking monitor interface. The docking monitor interface may be configured for electrically and/or mechanically connecting the monitor device to the docking station. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking monitor interface of the docking station may be configured to electrically and/or mechanically couple the docking station and the monitor device.
The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the docking station. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the docking station.
The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The docking monitor interface may comprise a ground terminal. The docking monitor interface may comprise a first terminal and/or a second terminal. The docking station may comprise a third terminal. The docking monitor interface may comprise a fourth terminal and/or a fifth terminal. The docking monitor interface optionally comprises a sixth terminal.
Disclosed is a method for manufacturing a base plate or a sensor assembly part, such as a base plate or a sensor assembly part for an ostomy appliance, such as a base plate or a sensor assembly part as disclosed above.
The method comprises positioning a coupling part, such as base plate coupling part or a sensor assembly coupling part, e.g. a coupling part of the monitor interface of the base plate or the sensor assembly part. The coupling part defines a terminal interface region, such as a region wherein terminals, e.g. of the base plate and/or sensor assembly part, may connect, such as mechanically and/or electrically connect, with respective terminals of a monitor device.
The method further comprises positioning an electrode assembly, such as the electrode assembly as disclosed above. The electrode assembly has a distal side and a proximal side. The electrode assembly and/or the coupling part is positioned such that the distal side of the electrode assembly is facing the coupling part. The electrode assembly comprises a support layer and one or more electrodes provided, such as formed, on a proximal side of the support layer. Each of the one or more electrodes comprises a connection part.
The method comprises inserting one or more terminal elements, such as the terminal elements as disclosed above, through the electrode assembly such that a distal part of each of the one or more terminal elements extends into the terminal interface region and a proximal part of each of the one or more terminal elements extends to the proximal side of the electrode assembly, and such that the proximal part of each of the one or more terminal elements are electrically connected with respective connection parts of the one or more electrodes, e.g. a first terminal element may be electrically connected with a connection part of a first electrode, a second terminal element may be electrically connected with a connection part of a second electrode, and so forth. For example, the one or more terminal elements, such as a proximal end or a distal end of each of the one or more terminal elements, may be used to penetrate the electrode assembly. Alternatively or additionally, holes may be provided in the electrode assembly, and/or other layers, prior to inserting the terminal elements. The terminal elements may be provided with pointed ends, e.g. to facilitate easier insertion and/or penetration.
Using the terminal elements to penetrate layers may provide the advantage that specific tools are not needed to provide holes in the respective layers. This may, in particular, be an advantage if the layers to be penetrated comprise adhesive, because adhesive will have a tendency to stick to the tools, and thereby extensive cleaning or frequent exchange of the tools may be required. Using the terminal elements to penetrate the respective layers may prevent physical contact between production tools and layers, such as adhesive layers.
The terminal elements extending through the electrode assembly and optionally other layers may provide for a connection on the distal side of the base plate and/or sensor assembly part allowing electrical connection to the one or more electrodes being provided on the proximal side of the electrode assembly.
The method may comprise positioning a first adhesive layer, such as the first adhesive layer as disclosed above, with a distal side facing the proximal side of the electrode assembly. The first adhesive layer may be positioned after inserting the one or more terminal elements. For example, such that the proximal part of each of the one or more terminal elements is located between the first adhesive layer and the electrode assembly.
A release liner may be provided on the proximal side of the first adhesive layer. The first adhesive layer may be formed on the release liner, e.g. by scraping a thin layer of a first composition, such as a first adhesive composition, onto the release liner to form the first adhesive layer. The first adhesive layer may be formed on the release liner prior to positioning the first adhesive layer, e.g. with the release liner.
The method may comprise positioning a second adhesive layer, such as the second adhesive layer as disclosed above, with a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly. The second adhesive layer may be positioned prior to inserting the one or more terminal elements. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements through the second adhesive layer. For example, the one or more terminal elements may be used to penetrate the second adhesive layer.
The method may comprise positioning a top layer, such as the top layer as disclosed above, with a distal side facing the coupling part and a proximal side facing the distal side of the second adhesive layer and/or the electrode assembly. The top layer may be positioned prior to inserting the one or more terminal elements. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements through the top layer. For example, the one or more terminal elements may be used to penetrate the top layer.
The second adhesive layer may be formed on the top layer, such as on the proximal side of the top layer, e.g. after the top layer is positioned. The second adhesive layer may be provided on the top layer by scraping a thin layer of a second composition, such as second adhesive composition, onto the top layer, such as on the proximal side of the top layer, to form the second adhesive layer.
The coupling part may be attached to the top layer. For example, the coupling part may be positioned on the distal side of the top layer and optionally the coupling part may be fixed, such as glued, soldered, or welded, to the top layer.
The positioning of the coupling part, the top layer, the second adhesive and/or the electrode assembly, may be done prior to inserting the one or more terminal elements, such that inserting the one or more terminal elements comprises inserting the one or more terminal elements through the electrode assembly, the second adhesive and/or the top layer, and into the terminal interface region. By using the terminal elements for penetrating through the layers of the base plate and/or the sensor assembly part, physical contact between manufacturing tools and layers of the base plate and/or the sensor assembly part, e.g. sticky layers, such as adhesive layers, may be omitted.
The one or more terminal elements may be inserted through the support layer of the electrode assembly. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements through the support layer of the electrode assembly, such as inserting the one or more terminal elements through the support layer while not penetrating the one or more electrodes. The terminal elements may be provided with a bend, such as a proximal terminal element bend, e.g. provided such that the proximal part of the terminal elements electrically connect with the respective connection parts of the one or more electrodes. The method may comprise providing each of the one or more terminal elements with a proximal terminal element bend, e.g. such that the proximal part of each of the one or more terminal element electrically connect with the respective connection parts of the one or more electrodes. For example, the method may comprise bending each of the one or more terminal elements and electrically connecting the proximal part of each of the one or more terminal elements with the respective connection part of the one or more electrodes. The method may comprise forming a proximal terminal element bend on each of the one or more terminal elements, e.g. after inserting the one or more terminal elements through the electrode assembly. Alternatively or additionally, the one or more terminal elements may be provided with the proximal terminal element bend prior to inserting the one or more terminal elements through the electrode assembly.
Alternatively, or additionally the one or more terminal elements may be inserted through the connection parts of the one or more electrodes. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements through the respective connection parts of the one or more electrodes.
Inserting the one or more terminal elements may comprise securing the distal part of each of the one or more terminal elements to the coupling part. For example, the one or more terminal elements may be inserted through the electrode assembly, the second adhesive and/or the top layer, and into the terminal interface region, and hereafter being secured to the coupling part. Securing the distal part of each of the one or more terminal elements to the coupling part may comprise positioning the distal part of each of the one or more terminal elements to contact a surface, such as a distal surface, of the coupling part. For example, each of the one or more terminal elements may be provided with a distal terminal element bend, e.g. to position the distal part of each of the one or more terminal elements to contact the surface of the coupling part. Positioning the distal part of each of the one or more terminal elements to contact a distal surface of the coupling part may facilitate a fastening of the coupling part towards the layers of the base plate and/or the sensor assembly part and/or facilitate that the proximal part of each of the one or more terminal elements may be pulled towards their respective connection parts by pulling the coupling part in a distal direction. The method may comprise providing each of the one or more terminal elements with a distal terminal element bend. For example, the method may comprise bending each of the one or more terminal elements, e.g. to achieve the distal terminal element bend. For example, the method may comprise forming a distal terminal element bend on each of the one or more terminal elements, e.g. after inserting the one or more terminal elements through the electrode assembly. Alternatively or additionally, the one or more terminal elements may be provided with the distal terminal element bend prior to inserting the one or more terminal elements through the electrode assembly.
The one or more terminal elements may be inserted from either side. Inserting the one or more terminal elements may comprise inserting the one or more terminal elements from the proximal side of the electrode assembly. Inserting the one or more terminals elements may comprises inserting the one or more terminal elements from the distal side of the electrode assembly.
A terminal element may be provided with a proximal terminal element bend and/or a distal terminal element bend. A terminal element bend, such as a proximal terminal element bend and/or a distal terminal element bend may be provided to a terminal element by applying a force to an end, such as a proximal end or distal end, of the terminal element, e.g. after insertion of the terminal element, in a direction non-parallel with a longitudinal direction of the terminal element.
Alternatively or additionally, a distal terminal element bend of a terminal element may be provided by applying a force to the terminal element, e.g. in a distal axial direction, such as towards a distal end of the terminal element and parallel to a longitudinal direction of the terminal element, and guiding the distal end of the terminal element, e.g. by a guide groove of a distal staple element, in a direction non-parallel with the longitudinal direction. Providing the distal terminal element bend by this method may be particularly advantageous if the terminal elements are inserted from the proximal side of the electrode assembly, e.g. because the force applied in the distal axial direction may be used also for insertion of the terminal element.
Similarly, a proximal terminal element bend of a terminal element may be provided by applying a force to the terminal element, e.g. in a proximal axial direction, such as towards a proximal end of the terminal element and parallel to the longitudinal direction of the terminal element, and guiding the proximal end of the terminal element, e.g. by a guide groove of a proximal staple element, in a direction non-parallel with the longitudinal direction. Providing the proximal terminal element bend by this method may be particularly advantageous if the terminal elements are inserted from the distal side of the electrode assembly, e.g. because the force applied in the proximal axial direction may be used also for insertion of the terminal element.
A terminal element bend, such as the proximal terminal element bend and/or the distal terminal element bend may form an angle, e.g. between 60-130 degrees, such as between 70-115 degrees, such as between 80-100 degrees. The angle of a terminal element bend, such as a proximal terminal element bend and/or a distal terminal element bend, may be defined relative to a straight terminal element, e.g. no bend has a 0 degrees angle and a U-shaped bend has a 180 degrees angle.
A terminal element bend, such as the proximal terminal element bend and/or the distal terminal element bend may be formed prior to inserting the one or more terminal elements through the electrode assembly. Alternatively or additionally, a terminal element bend, such as the proximal terminal element bend and/or the distal terminal element bend may be formed after inserting the one or more terminal elements through the electrode assembly.
A base plate for an ostomy appliance is also disclosed, such as a base plate manufactured by a method, such as the previously disclosed method. Also, a sensor assembly part for an ostomy appliance is disclosed, such as a sensor assembly part for being applied to a base plate, such as a sensor assembly part manufactured by a method, such as the previously disclosed method. The base plate and/or the sensor assembly part comprises: a coupling part defining a terminal interface region; an electrode assembly having a distal side and a proximal side; and one or more terminal elements extending through the electrode assembly.
The distal side of the electrode assembly is facing the coupling part. The electrode assembly comprises a support layer and one or more electrodes provided on a proximal side of the support layer. Each of the one or more electrodes comprising a connection part.
Each of the one or more terminal elements have a distal part extending into the terminal interface region and a proximal part extending to the proximal side of the electrode assembly. The proximal part of each of the one or more terminal elements are electrically connected to respective connection parts of the one or more electrodes.
The coupling part defines a terminal interface region, such as a region wherein terminals, e.g. of the base plate and/or sensor assembly part, may connect, such as mechanically and/or electrically connect, with respective terminals of a monitor device. The terminal interface region need not be a structurally delimited and/or visible region. The terminal interface region may be a region adjacent to the coupling part. Alternatively or additionally, The terminal interface region may be surrounded by the coupling part, such as a region surrounded by the coupling part. The terminal interface region may be within a 20 mm radius of the coupling part, such as within a 10 mm radius of the coupling part, such as within a 5 mm radius of the coupling part, such as within a 1 mm radius of the coupling part. The coupling part may surround the terminal interface region. The coupling part may have one or more outer sides including a first outer side. The terminal interface region may be adjacent an outer side of the coupling part, such as the first outer side.
The base plate and/or the sensor assembly part may comprise a first adhesive layer, such as the first adhesive layer as previously disclosed. The first adhesive layer may have a distal side facing the proximal side of the electrode assembly. The proximal part of each of the one or more terminal elements may be located between the first adhesive layer and the electrode assembly.
The base plate and/or the sensor assembly part may comprise a second adhesive layer, such as the second adhesive layer as previously disclosed. The second adhesive layer may have a distal side facing the coupling part and a proximal side facing the distal side of the electrode assembly. The one or more terminal elements may extend through the second adhesive layer.
The base plate and/or the sensor assembly part may comprise a top layer, such as the top layer as previously disclosed. The top layer may have a distal side facing the coupling part. The top layer may have a proximal side facing the distal side of the second adhesive layer and/or the distal side of the electrode assembly. The one or more terminal elements may extend through the top layer. The coupling part may be attached to the top layer. For example, the coupling part may be fixed, such as glued, soldered, or welded, to the distal side of the top layer.
The one or more terminal elements may have a proximal terminal element bend. The proximal part of each of the one or more terminal elements may electrically connect with the respective connection parts of the one or more electrodes. The one or more terminal elements may extend through the respective connection parts of the one or more electrodes.
The one or more terminal elements may have a distal terminal element bend. The distal part of each of the one or more terminal elements may be secured to a surface, such as a distal surface, of the coupling part.
The ostomy system 1 optionally comprises a docking station 20 forming an accessory device of the ostomy system 1. The docking station 20 comprises a docking monitor interface including a first connector 22 configured for electrically and/or mechanically connecting the monitor device 6 to the docking station 20. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking station 20 comprises a user interface 24 for receiving user input and/or providing feedback to the user on the operational state of the docking station 20. The user interface 24 may comprise a touch-screen. The user interface 24 may comprise one or more physical buttons and/or one or more visual indicators, such as light emitting diodes.
The first interface 102 is configured as an appliance interface for electrically and/or mechanically connecting the monitor device 6 to the ostomy appliance, e.g. ostomy appliance 2. The first interface 102 comprises a plurality of terminals for forming electrical connections with respective terminals of the ostomy appliance 2 (base plate 4). The first interface 102 comprises a ground terminal 108, a first terminal 110, a second terminal 112 and a third terminal 114. The first interface 102 optionally comprises a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 comprises a coupling part 120 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least part of) a first connector of the monitor device 6.
The monitor device 6 comprises a power unit 121 for powering the monitor device and active components thereof, i.e. the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and memory 106. The power unit comprises a battery and charging circuitry. The charging circuitry is connected to the battery and terminals of the first interface 102 for charging the battery via terminals of the first interface, e.g. terminals of the first connector.
The second interface 104 of monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices such as accessory device 8. The second interface 104 comprises an antenna 122 and a wireless transceiver 124 configured for wireless communication with accessory device(s). Optionally, the second interface 104 comprises a loudspeaker 126 and/or a haptic feedback element 128 for provision of respective audio signal and/or haptic feedback to the user.
The monitor device 6 comprises a sensor unit 140 connected to the processor 101. The sensor unit 140 comprises a temperature sensor for feeding temperature data to the processor and a G-sensor or accelerometer for feeding acceleration data to the processor 101.
The processor 101 is configured to apply a processing scheme, and the first interface 102 is configured for collecting ostomy data from the base plate coupled to the first interface, the ostomy data comprising first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. The ostomy data may be stored in the memory 106 and/or processed in the processor 101 in order to obtain parameter data. The parameter data may be stored in the memory 106. The processor 101 is configured to apply a processing scheme, wherein to apply a processing scheme comprises obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; obtain third parameter data based on the third ostomy data. In other words, the processor 101 is configured to obtain first, second and third parameter data based on respective first, second and third ostomy data. To apply a processing scheme comprises to determine an operating state of the base plate of the ostomy appliance based on one or more, e.g. all, of the first parameter data, the second parameter data and the third parameter data, wherein the operating state is indicative of a degree of radial erosion of the base plate and/or acute leakage risk for the ostomy appliance. The monitor device 6 is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.
The base plate 4 comprises a monitor interface. The monitor interface is configured for electrically and/or mechanically connecting the ostomy appliance (base plate 4) to the monitor device. The monitor interface of the base plate comprises a coupling part 210 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 210 is configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate 4. Further, the monitor interface of the base plate 4 comprises a plurality of terminal elements respectively forming a plurality of terminals 212 for forming electrical connections with respective terminals of the monitor device. The coupling part 210 and the terminals 212 form a first connector 211 of the base plate 4. The base plate 4 comprises a first intermediate element 213 on the proximal side of the electrode assembly. The first intermediate element 213 is arranged between the terminal elements forming terminals 212 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements forming terminals 212 of the base plate 4 when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.
As previously described, some parts of the illustrated base plate 4, may be provided as a separate assembly to be applied to an existing base plate, e.g. comprising one or more of the components as described, such as to provide a base plate like the base plate 4 as described. For example, a sensor assembly part 700 may be provided, e.g. comprising the electrode assembly 204, the first connector 211, the first intermediate element 213, the first adhesive layer 200 and the release liner 206. Additionally, the sensor assembly part 700 may also comprise the second adhesive layer 202 and/or the top layer 208. It may be envisioned that the user may provide a hole in layers of the base plate whereto the sensor assembly part 700 is to be applied, to allow for the first connector 211 of the sensor assembly part 700 to protrude through layers of the base plate whereto the sensor assembly part 700 is applied. Alternatively, the sensor assembly part 700 may be applied to the base plate such that the first connector 211 is positioned outside the periphery of the base plate.
The fourth electrode 230 comprises fourth sensing parts 230B. The fifth electrode 232 comprises fifth sensing parts 232B.
The ground electrode 222 comprises a first electrode part 234 for forming a ground for the first electrode 224. The ground electrode 222 comprises a second electrode part 236 for forming a ground for the second electrode 226. The ground electrode 222 comprises a third electrode part 238 for forming a ground for the third electrode 228. The ground electrode 222 comprises a fourth electrode part 240 for forming a ground for the fourth electrode 230 and the fifth electrode 232. The fourth electrode part 240 of the ground electrode 222 comprises ground sensing parts 222B
The masking element 218 has a plurality of sensor point openings. The sensor point openings comprise primary sensor point openings shown within dotted line 254, each primary sensor point opening configured to overlap a part of the ground electrode 222 and/or a part of the fourth electrode 230. The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, five primary first sensor point openings 254A each configured to overlap a part of the ground electrode 222. The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, four primary second sensor point openings 254B each configured to overlap a part of the fourth electrode 230. The sensor point openings comprise secondary sensor point openings shown within dotted line 256, each second sensor point opening configured to overlap a part of the fourth electrode 230 and/or a part of the fifth electrode 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, five secondary first sensor point openings 256A each configured to overlap a part of the fifth electrode 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, four secondary second sensor point openings 256B each configured to overlap a part of the fourth electrode 230. The sensor point openings comprise tertiary sensor point openings shown within dotted line 258, each tertiary sensor opening configured to overlap a part of the fifth electrode 232 and/or a part of the ground electrode 222. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, five tertiary first sensor point openings 258A each configured to overlap a part of the fifth electrode 232. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, four tertiary second sensor point openings 258B each configured to overlap a part of the ground electrode 222.
The plurality of terminals of the first connector 211 of the monitor interface comprises a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and a third terminal element 288 forming a third terminal 288A. The monitor interface optionally comprises a fourth terminal element 290 forming a fourth terminal 290A and/or a fifth terminal element 292 forming a fifth terminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contact respective connection parts 222A, 224A, 226A, 228A, 230a, 232A of electrodes 222, 224, 226, 228, 230, 232.
The method 1000 comprises positioning 1002 a coupling part 210. The coupling part 210 defines a terminal interface region 270. For example, the terminal interface region 270 may be a region surrounded by the coupling part 210, and/or the terminal interface region 270 may be a region adjacent to the coupling part 210.
The method 1000 comprises positioning 1004 an electrode assembly 204 having a distal side 204A and a proximal side 204B. The electrode assembly 204 and/or the coupling part 210 is positioned such that the distal side 204A of the electrode assembly 204 is facing the coupling part 210. The electrode assembly 204 comprises a support layer 214 and one or more electrodes 216 provided on a proximal side 214B of the support layer 214. Each of the one or more electrodes 216 comprising a connection part 217.
The method 1000 comprises inserting 1006 one or more terminal elements 272, e.g. such as the terminal elements 282, 284, 286, 288, 290, 292 of
The one or more terminal elements may be inserted 1006 from the proximal side 204B of the electrode assembly 204. Alternatively, the one or more terminal elements 272 may be inserted 1006 from the distal side 204A of the electrode assembly 204.
The one or more terminal elements 272, such as a distal end or a proximal end of each of the one or more terminal elements 272, may be used in inserting 1006 the one or more terminal elements 272 to penetrate the electrode assembly 202.
The one or more terminal elements 272 may be inserted 1006 through the support layer 214 of the electrode assembly, such as without penetrating the electrodes 216 of the electrode assembly 204. Alternatively, the one or more terminal elements 272 may be inserted 1006 through the respective connection parts 217.
In inserting 1006 the one or more terminal elements 272, the distal part 274A of each of the one or more terminal elements may be secured to the coupling part 210. Securing the distal part 274A of each of the one or more terminal elements 272 to the coupling part 210 may comprise positioning the distal part 274A of each of the one or more terminal elements 272 to contact a surface, such as a distal surface, of the coupling part 210. Alternatively or additionally, the distal part 274A may be secured to the coupling part 210 by engaging with a clamping element of the coupling part 210.
The method 1000 further comprises an optional step of positioning 1008 a first adhesive layer 200. The first adhesive layer 200 comprises a distal side and a proximal side. The first adhesive layer 200 is positioned 1008 such that the distal side of the first adhesive layer 200 is facing the proximal side of the electrode assembly 204. The first adhesive layer 200 may be positioned 1008 after inserting 1006 the one or more terminal elements such that the proximal part 274B of each of the one or more terminal elements 272 is located between the first adhesive layer 200 and the electrode assembly 204.
The first adhesive layer 200 may be positioned 1008 together with a release liner 206 provided on the proximal side of the first adhesive layer 200. The first adhesive layer 200 may be formed on the release liner 206 by scraping a thin layer of a first adhesive composition onto the release liner 206 to form the first adhesive layer 200. The first adhesive layer 200 may be formed on the release liner prior to positioning 1008 the first adhesive layer 200, e.g. with the release liner 206.
The method 1000 provides that an electrical connection is provided from the distal side of the base plate 4 and/or the sensor assembly part 700 to the electrodes 216 of the electrode assembly 204 being positioned on a proximal facing side of the electrode assembly 204. The proximal position of the electrodes 216 may provide for better measuring of leakage and/or wear of the base plate.
The method 1000′ comprises the same steps as the method 1000 as explained in relation to
The method 1000′ comprises positioning 1010 a top layer 208. The top layer 208 has a distal side and a proximal side. The top layer 208 is positioned 1010 such that the distal side of the top layer 208 is facing the coupling part and the proximal side of the top layer 208 is facing the distal side of the electrode assembly 204.
The method 1000′ comprises positioning 1012 a second adhesive layer 202. The second adhesive layer 202 has a distal side and a proximal side. The second adhesive layer is positioned 1012 such that the distal side of the second adhesive layer 202 is facing the coupling part and the proximal side of the second adhesive layer 202 is facing the distal side of the electrode assembly 204. The second adhesive layer 202 may be positioned 1012 on the top layer 208, e.g. after the top layer 208 is positioned 1010. The second adhesive layer 202 may be positioned 1012 on the top layer 208 by scraping a thin layer of a second adhesive composition onto the top layer 208 to form the second adhesive layer 202. Positioning 1010 the top layer 208 and positioning 1012 the second adhesive layer may be performed simultaneously.
The second adhesive layer 202 may be positioned 1012 prior to inserting 1006 the one or more terminal elements 272 and/or the top layer 208 may be positioned 1010 prior to inserting the 1006 the one or more terminal elements 272. Inserting 1006 the one or more terminal elements 272 may comprise inserting the one or more terminal elements 272 through the second adhesive layer 202 and/or the top layer 208.
The one or more terminal elements 272, such as a distal end or proximal end of each of the one or more terminal elements 272, may be used in inserting 1006 the one or more terminal elements 272 to penetrate the electrode assembly 202, the second adhesive layer 202 and/or the top layer 208.
The method 1000′ comprises providing 1014 each of the one or more terminal elements 272 with a proximal terminal element bend 276B. For example, providing 1014 proximal terminal element bend(s) may comprise forming a proximal terminal element bend to each of the one or more terminal elements 272. A proximal terminal element bend 276B may provide that the proximal part 274B of each of the one or more terminal element 272 electrically connect with the respective connection parts 217 of the one or more electrodes 216. Providing 1014 each of the one or more terminal elements 272 with a proximal terminal element bend 276B may in particular be advantageous to provide an electrical connection between the terminal elements 272 and the respective connection parts 217, if the terminal elements 272 are penetrating the support layer 214 and not penetrating the electrodes 216. Providing 1014 each of the one or more terminal elements 272 with a proximal terminal element bend 276B may be performed after inserting 1006 the one or more terminal elements 272. Alternatively, providing 1014 the proximal terminal element bend(s) 276B may be performed prior to inserting 1006 the one or more terminal elements 272.
The method 1000′ comprises providing 1016 each of the one or more terminal elements 272 with a distal terminal element bend 276A. For example, providing 1016 distal terminal element bend(s) may comprise forming a distal terminal element bend to each of the one or more terminal elements 272. Providing 1016 each of the one or more terminal elements 272 with a distal terminal element bend 276A may be provided to position the distal part 274A of each of the one or more terminal elements 272 to contact the distal surface of the coupling part 210, e.g. to secure the distal part 274A of each of the one or more terminal elements 272 to the coupling part 210.
A coupling part 210, a top layer 208 and an electrode assembly 204 are positioned such that a distal side of the electrode assembly 204 is facing the coupling part 210, and such that the top layer 208 is between the coupling part 210 and the electrode assembly 204. A second adhesive layer (not shown) may be positioned between the top layer 208 and the electrode assembly 204.
In
The coupling part 210 comprises guide holes 278 for receiving terminal elements 272 being inserted through the coupling part 210 from the proximal side. The guide holes 278 may facilitate positioning of the terminal elements 272.
After inserting the terminal elements 272 through the electrode assembly 204 and the top layer 208, the terminal elements 272 are provided with distal terminal element bends 276A, as shown in
After providing the terminal elements 272 with distal terminal element bends 276A, the terminal elements 272 are provided with proximal terminal element bends 276B, as shown in
The base plate 4 and/or the sensor assembly part 700 comprises a top layer 208. The top layer 208 has a distal side facing the coupling part 210 and a proximal side facing the distal side of the electrode assembly 204. The terminal elements 272 are extending through the top layer 208. If the base plate 4 and/or the sensor assembly part 700 had a second adhesive layer, as described in relation to other figures, the proximal side of the top layer 208 could be facing the second adhesive layer.
The base plate 4 and/or the sensor assembly part 700 as illustrated in
The position of the first connector on the base plate and/or the sensor assembly part, the number of terminals and the position of the terminals in the coupling part may be adapted to the electrode configuration used in the electrode assembly of the base plate and/or the sensor assembly part.
The use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order, but are included to identify individual elements. Moreover, the use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not denote any order or importance, but rather the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used to distinguish one element from another. Note that the words “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used here and elsewhere for labelling purposes only and are not intended to denote any specific spatial or temporal ordering. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa.
Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications and equivalents.
Embodiments of the present disclosure is set out in the following items:
1. Method for manufacturing a base plate or a sensor assembly part for an ostomy appliance, the method comprising:
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2017 70982 | Dec 2017 | DK | national |
| PA 2017 70998 | Dec 2017 | DK | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/DK2018/050383 | 12/20/2018 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2019/120427 | 6/27/2019 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 2327514 | Fenwick | Aug 1943 | A |
| 2542233 | Carroll | Feb 1951 | A |
| 2544579 | Ardner | Mar 1951 | A |
| 3214502 | Schaar | Oct 1965 | A |
| 3832510 | Pfau et al. | Aug 1974 | A |
| 3915171 | Shermeta | Oct 1975 | A |
| 3941133 | Chen | Mar 1976 | A |
| 4372308 | Steer | Feb 1983 | A |
| 4449970 | Bevan et al. | May 1984 | A |
| 4668227 | Kay | May 1987 | A |
| 4754264 | Okada et al. | Jun 1988 | A |
| 4775374 | Cilento et al. | Oct 1988 | A |
| 4982742 | Claude | Jan 1991 | A |
| 5016645 | Williams et al. | May 1991 | A |
| 5051259 | Olsen | Sep 1991 | A |
| 5074851 | Plass et al. | Dec 1991 | A |
| 5111812 | Swanson et al. | May 1992 | A |
| 5167650 | Johnsen et al. | Dec 1992 | A |
| 5237995 | Cano | Aug 1993 | A |
| 5318543 | Ross et al. | Jun 1994 | A |
| 5358488 | Suriyapa | Oct 1994 | A |
| 5486158 | Samuelsen | Jan 1996 | A |
| 5570082 | Mahgerefteh et al. | Oct 1996 | A |
| 5593397 | La Gro | Jan 1997 | A |
| 5672163 | Ferreira et al. | Sep 1997 | A |
| 5677221 | Tseng | Oct 1997 | A |
| 5704905 | Jensen et al. | Jan 1998 | A |
| 5790036 | Fisher et al. | Aug 1998 | A |
| 5800415 | Olsen | Sep 1998 | A |
| 5816252 | Faries, Jr. et al. | Oct 1998 | A |
| 5834009 | Sawers et al. | Nov 1998 | A |
| 5879292 | Sternberg et al. | Mar 1999 | A |
| 5942186 | Sanada et al. | Aug 1999 | A |
| 6015399 | Mracna et al. | Jan 2000 | A |
| 6025725 | Gershenfeld et al. | Feb 2000 | A |
| 6057689 | Saadat | May 2000 | A |
| 6103033 | Say et al. | Aug 2000 | A |
| 6135986 | Leisner et al. | Oct 2000 | A |
| 6171289 | Millot | Jan 2001 | B1 |
| 6206864 | Kavanagh et al. | Mar 2001 | B1 |
| 6407308 | Roe et al. | Jun 2002 | B1 |
| 6433244 | Roe et al. | Aug 2002 | B1 |
| 6482491 | Samuelsen et al. | Nov 2002 | B1 |
| 6485476 | von Dyck et al. | Nov 2002 | B1 |
| 6659989 | Otto | Dec 2003 | B1 |
| 6764474 | Nielsen et al. | Jul 2004 | B2 |
| 7066919 | Sauerland et al. | Jun 2006 | B1 |
| 7150728 | Hansen et al. | Dec 2006 | B2 |
| 7166091 | Zeltner | Jan 2007 | B1 |
| 7199501 | Pei et al. | Apr 2007 | B2 |
| 7214217 | Pedersen et al. | May 2007 | B2 |
| 7326190 | Botten | Feb 2008 | B2 |
| 7341578 | Bulow et al. | Mar 2008 | B2 |
| 7367965 | Poulsen et al. | May 2008 | B2 |
| 7559922 | Botten | Jul 2009 | B2 |
| 7625362 | Boehringer et al. | Dec 2009 | B2 |
| 7641612 | McCall | Jan 2010 | B1 |
| 7670289 | McCall | Mar 2010 | B1 |
| 7943812 | Stroebeck et al. | May 2011 | B2 |
| 7981098 | Boehringer et al. | Jul 2011 | B2 |
| 8061360 | Locke et al. | Nov 2011 | B2 |
| 8277427 | Edvardsen et al. | Oct 2012 | B2 |
| 8319003 | Olsen et al. | Nov 2012 | B2 |
| 8398575 | McCall | Mar 2013 | B1 |
| 8398603 | Thirstrup | Mar 2013 | B2 |
| 8399732 | Oelund et al. | Mar 2013 | B2 |
| 8409158 | Edvardsen et al. | Apr 2013 | B2 |
| 8449471 | Tran | May 2013 | B2 |
| 8500718 | Locke et al. | Aug 2013 | B2 |
| 8632492 | DeLegge | Jan 2014 | B2 |
| 8680991 | Tran | Mar 2014 | B2 |
| 8684982 | Nguyen-Demary et al. | Apr 2014 | B2 |
| 8740865 | Krystek et al. | Jun 2014 | B2 |
| 8795257 | Coulthard et al. | Aug 2014 | B2 |
| 8821464 | Hanuka et al. | Sep 2014 | B2 |
| 8975465 | Hong et al. | Mar 2015 | B2 |
| 9046085 | Schoess et al. | Jun 2015 | B2 |
| 9066812 | Edvardsen et al. | Jun 2015 | B2 |
| 9216104 | Thirstrup | Dec 2015 | B2 |
| 9308332 | Heppe | Apr 2016 | B2 |
| 9322797 | Lastinger et al. | Apr 2016 | B1 |
| 9629964 | Wuepper | Apr 2017 | B2 |
| 9693908 | Eriksson et al. | Jul 2017 | B2 |
| 9770359 | Edvardsen et al. | Sep 2017 | B2 |
| 9788991 | Bird | Oct 2017 | B2 |
| 9867934 | Heppe | Jan 2018 | B2 |
| 9928341 | Angelides | Mar 2018 | B2 |
| 10016298 | Thirstrup | Jul 2018 | B2 |
| D826740 | Stevens et al. | Aug 2018 | S |
| 10500084 | Hansen | Dec 2019 | B2 |
| 10531977 | Schoess | Jan 2020 | B2 |
| 10646370 | Keleny et al. | May 2020 | B2 |
| 10792184 | Hvid et al. | Oct 2020 | B2 |
| 10799385 | Hansen | Oct 2020 | B2 |
| 10849781 | Hansen | Dec 2020 | B2 |
| 10874541 | Seres | Dec 2020 | B2 |
| 10987243 | Thirstrup | Apr 2021 | B2 |
| 11096818 | Thirstrup | Aug 2021 | B2 |
| 11135084 | Seres | Oct 2021 | B2 |
| 11406525 | Seres | Aug 2022 | B2 |
| 11471318 | Hansen et al. | Oct 2022 | B2 |
| 20020019615 | Roe et al. | Feb 2002 | A1 |
| 20030132763 | Ellenz | Jul 2003 | A1 |
| 20030169032 | Minchole et al. | Sep 2003 | A1 |
| 20040030305 | Sakamoto | Feb 2004 | A1 |
| 20040036484 | Tamai | Feb 2004 | A1 |
| 20040049145 | Flick | Mar 2004 | A1 |
| 20040078219 | Kaylor et al. | Apr 2004 | A1 |
| 20040100376 | Lye et al. | May 2004 | A1 |
| 20040111072 | McKissick | Jun 2004 | A1 |
| 20040133175 | Hagedorn-Olsen | Jul 2004 | A1 |
| 20040171999 | Andersen et al. | Sep 2004 | A1 |
| 20040216833 | Fleming et al. | Nov 2004 | A1 |
| 20050054997 | Buglino et al. | Mar 2005 | A1 |
| 20050065488 | Elliott | Mar 2005 | A1 |
| 20050070863 | Bulow et al. | Mar 2005 | A1 |
| 20050085779 | Poulsen et al. | Apr 2005 | A1 |
| 20050101841 | Kaylor et al. | May 2005 | A9 |
| 20050240163 | Andersen | Oct 2005 | A1 |
| 20050261645 | Conrad et al. | Nov 2005 | A1 |
| 20060015081 | Suzuki et al. | Jan 2006 | A1 |
| 20060025727 | Boehringer et al. | Feb 2006 | A1 |
| 20060052752 | McMichael | Mar 2006 | A1 |
| 20060194324 | Faries, Jr. et al. | Aug 2006 | A1 |
| 20060271002 | Botten | Nov 2006 | A1 |
| 20070035405 | Wada et al. | Feb 2007 | A1 |
| 20070135782 | Bager et al. | Jun 2007 | A1 |
| 20070185464 | Fattman et al. | Aug 2007 | A1 |
| 20080071214 | Locke et al. | Mar 2008 | A1 |
| 20080075934 | Barlow, Jr. et al. | Mar 2008 | A1 |
| 20080091154 | Botten | Apr 2008 | A1 |
| 20080140057 | Wood et al. | Jun 2008 | A1 |
| 20080234641 | Locke et al. | Sep 2008 | A1 |
| 20080275327 | Faarbaek | Nov 2008 | A1 |
| 20080278337 | Huang et al. | Nov 2008 | A1 |
| 20080300559 | Gustafson et al. | Dec 2008 | A1 |
| 20080306459 | Albrectsen | Dec 2008 | A1 |
| 20090012501 | Boehringer et al. | Jan 2009 | A1 |
| 20090118600 | Ortiz et al. | May 2009 | A1 |
| 20090118687 | Kristensen et al. | May 2009 | A1 |
| 20090167286 | Naylor et al. | Jul 2009 | A1 |
| 20090173935 | Cho et al. | Jul 2009 | A1 |
| 20090227969 | Jaeb et al. | Sep 2009 | A1 |
| 20090247970 | Keleny et al. | Oct 2009 | A1 |
| 20100010460 | Butler | Jan 2010 | A1 |
| 20100030167 | Thirstrup | Feb 2010 | A1 |
| 20100036206 | Lorio | Feb 2010 | A1 |
| 20100072271 | Thorstensson | Mar 2010 | A1 |
| 20110034890 | Stroebech et al. | Feb 2011 | A1 |
| 20110077497 | Oster et al. | Mar 2011 | A1 |
| 20110130642 | Jaeb et al. | Jun 2011 | A1 |
| 20120013130 | Jung | Jan 2012 | A1 |
| 20120143154 | Edvardsen | Jun 2012 | A1 |
| 20120143155 | Edvardsen | Jun 2012 | A1 |
| 20120253224 | Mir et al. | Oct 2012 | A1 |
| 20120258302 | Hunt et al. | Oct 2012 | A1 |
| 20120259230 | Riley | Oct 2012 | A1 |
| 20120283678 | Nguyen-Demary et al. | Nov 2012 | A1 |
| 20130018231 | Hong et al. | Jan 2013 | A1 |
| 20130030167 | Wang et al. | Jan 2013 | A1 |
| 20130030397 | Sabeti | Jan 2013 | A1 |
| 20130060213 | Hanuka et al. | Mar 2013 | A1 |
| 20130066285 | Locke et al. | Mar 2013 | A1 |
| 20130072886 | Schertiger et al. | Mar 2013 | A1 |
| 20130102979 | Coulthard et al. | Apr 2013 | A1 |
| 20130138065 | Buus | May 2013 | A1 |
| 20130150769 | Heppe | Jun 2013 | A1 |
| 20130165862 | Griffith et al. | Jun 2013 | A1 |
| 20130192604 | Persson et al. | Aug 2013 | A1 |
| 20130226116 | Edvardsen et al. | Aug 2013 | A1 |
| 20130231620 | Thirstrup | Sep 2013 | A1 |
| 20130261575 | Kiyoshi | Oct 2013 | A1 |
| 20130303867 | Elfstrom et al. | Nov 2013 | A1 |
| 20130324952 | Krystek et al. | Dec 2013 | A1 |
| 20140051946 | Arne et al. | Feb 2014 | A1 |
| 20140200538 | Euliano et al. | Jul 2014 | A1 |
| 20140236111 | Casado et al. | Aug 2014 | A1 |
| 20140236335 | Lewis et al. | Aug 2014 | A1 |
| 20140275854 | Venkatraman et al. | Sep 2014 | A1 |
| 20140276501 | Cisko | Sep 2014 | A1 |
| 20140288381 | Faarbaek | Sep 2014 | A1 |
| 20140323909 | Kim | Oct 2014 | A1 |
| 20140327433 | Anway et al. | Nov 2014 | A1 |
| 20140336493 | Kulach et al. | Nov 2014 | A1 |
| 20150231802 | Quan et al. | Aug 2015 | A1 |
| 20150250639 | Thirstrup | Sep 2015 | A1 |
| 20150257923 | Thirstrup | Sep 2015 | A1 |
| 20150342777 | Seres et al. | Dec 2015 | A1 |
| 20150374896 | Du et al. | Dec 2015 | A1 |
| 20160084869 | Yuen et al. | Mar 2016 | A1 |
| 20160158056 | Davis | Jun 2016 | A1 |
| 20160158969 | McLane et al. | Jun 2016 | A1 |
| 20160166438 | Rovaniemi | Jun 2016 | A1 |
| 20160218555 | Slaby et al. | Jul 2016 | A1 |
| 20160235581 | Keleny et al. | Aug 2016 | A1 |
| 20160278990 | Chen | Sep 2016 | A1 |
| 20160284084 | Gurcan et al. | Sep 2016 | A1 |
| 20160305776 | Mårtensson et al. | Oct 2016 | A1 |
| 20160310140 | Belson et al. | Oct 2016 | A1 |
| 20160310329 | Patel et al. | Oct 2016 | A1 |
| 20160361015 | Wang et al. | Dec 2016 | A1 |
| 20170042614 | Salahieh et al. | Feb 2017 | A1 |
| 20170050004 | Tilson et al. | Feb 2017 | A1 |
| 20170055896 | Al-Ali et al. | Mar 2017 | A1 |
| 20170079576 | Stroebech et al. | Mar 2017 | A1 |
| 20170112658 | Hosono | Apr 2017 | A1 |
| 20170140103 | Angelides | May 2017 | A1 |
| 20170156920 | Hunt et al. | Jun 2017 | A1 |
| 20170262986 | Xiong et al. | Sep 2017 | A1 |
| 20170340474 | Thirstrup | Nov 2017 | A1 |
| 20170348137 | Hvid et al. | Dec 2017 | A1 |
| 20170360592 | Carrubba | Dec 2017 | A1 |
| 20180049667 | Heppe | Feb 2018 | A1 |
| 20180055359 | Shamim et al. | Mar 2018 | A1 |
| 20180171183 | Sakurai et al. | Jun 2018 | A1 |
| 20190133810 | Seres et al. | May 2019 | A1 |
| 20190133811 | Seres | May 2019 | A1 |
| 20190133812 | Seres | May 2019 | A1 |
| 20190142623 | Schoess | May 2019 | A1 |
| 20190175386 | Monty | Jun 2019 | A1 |
| 20190192066 | Schoess et al. | Jun 2019 | A1 |
| 20190192332 | Hansen | Jun 2019 | A1 |
| 20190192333 | Hansen | Jun 2019 | A1 |
| 20190192334 | Hansen | Jun 2019 | A1 |
| 20190240059 | Seres et al. | Aug 2019 | A1 |
| 20190247050 | Goldsmith | Aug 2019 | A1 |
| 20190374163 | Faarbaek | Dec 2019 | A1 |
| 20190374372 | Seres et al. | Dec 2019 | A1 |
| 20200100931 | Schoess et al. | Apr 2020 | A1 |
| 20200188161 | Seres et al. | Jun 2020 | A1 |
| 20200246174 | Hansen | Aug 2020 | A1 |
| 20200246175 | Hansen | Aug 2020 | A1 |
| 20200246176 | Hansen | Aug 2020 | A1 |
| 20200246177 | Hansen | Aug 2020 | A1 |
| 20200276063 | Muñoz Herencia | Sep 2020 | A1 |
| 20200306074 | Speiermann | Oct 2020 | A1 |
| 20200330258 | Hansen | Oct 2020 | A1 |
| 20200330260 | Hansen | Oct 2020 | A1 |
| 20200337880 | Hansen | Oct 2020 | A1 |
| 20200337881 | Hansen | Oct 2020 | A1 |
| 20200337882 | Hansen | Oct 2020 | A1 |
| 20200337883 | Hansen | Oct 2020 | A1 |
| 20200375499 | Hansen | Dec 2020 | A1 |
| 20200375782 | Hansen | Dec 2020 | A1 |
| 20200375783 | Hansen | Dec 2020 | A1 |
| 20200375784 | Hansen | Dec 2020 | A1 |
| 20200375785 | Hansen | Dec 2020 | A1 |
| 20200375786 | Hansen | Dec 2020 | A1 |
| 20200383637 | Hansen | Dec 2020 | A1 |
| 20200383818 | Hansen | Dec 2020 | A1 |
| 20200383819 | Sletten | Dec 2020 | A1 |
| 20200383820 | Hansen | Dec 2020 | A1 |
| 20200383821 | Hansen | Dec 2020 | A1 |
| 20200390587 | Svanegaard et al. | Dec 2020 | A1 |
| 20200390588 | Hansen et al. | Dec 2020 | A1 |
| 20200390589 | Hansen et al. | Dec 2020 | A1 |
| 20200395120 | Svanegaard et al. | Dec 2020 | A1 |
| 20200395610 | Ono et al. | Dec 2020 | A1 |
| 20200405228 | Svanegaard et al. | Dec 2020 | A1 |
| 20200405229 | Svanegaard et al. | Dec 2020 | A1 |
| 20200405230 | Svanegaard et al. | Dec 2020 | A1 |
| 20210000414 | Svanegaard et al. | Jan 2021 | A1 |
| 20210000633 | Hansen et al. | Jan 2021 | A1 |
| 20210000634 | Svanegaard et al. | Jan 2021 | A1 |
| 20210000635 | Hansen | Jan 2021 | A1 |
| 20210000636 | Hansen | Jan 2021 | A1 |
| 20210007663 | Svanegaard et al. | Jan 2021 | A1 |
| 20210007881 | Svanegaard et al. | Jan 2021 | A1 |
| 20210015653 | Hansen | Jan 2021 | A1 |
| 20210015654 | Hansen et al. | Jan 2021 | A1 |
| 20210022683 | Faarbaek et al. | Jan 2021 | A1 |
| 20210038424 | Svanegaard et al. | Feb 2021 | A1 |
| 20210059603 | Svanegaard et al. | Mar 2021 | A1 |
| 20210085511 | Hansen et al. | Mar 2021 | A1 |
| 20210085512 | Hansen et al. | Mar 2021 | A1 |
| 20210177642 | Andersen et al. | Jun 2021 | A1 |
| 20210212855 | Hansen et al. | Jul 2021 | A1 |
| 20210338471 | Nolan et al. | Nov 2021 | A1 |
| 20210361464 | Larsen et al. | Nov 2021 | A1 |
| 20210361465 | Hansen et al. | Nov 2021 | A1 |
| 20210361466 | Hansen | Nov 2021 | A1 |
| 20210361467 | Hansen et al. | Nov 2021 | A1 |
| 20210369197 | Hansen et al. | Dec 2021 | A1 |
| 20210369488 | Hansen et al. | Dec 2021 | A1 |
| 20210369489 | Hansen et al. | Dec 2021 | A1 |
| 20210369490 | Hansen et al. | Dec 2021 | A1 |
| 20210386368 | Carlsson et al. | Dec 2021 | A1 |
| 20220000652 | Thirstrup | Jan 2022 | A1 |
| 20220031495 | Seres et al. | Feb 2022 | A1 |
| 20220079802 | Hansen | Mar 2022 | A1 |
| 20220079803 | Windeballe et al. | Mar 2022 | A1 |
| 20220087851 | Stroebech | Mar 2022 | A1 |
| 20220117771 | Fearn et al. | Apr 2022 | A1 |
| 20220142807 | Tofte | May 2022 | A1 |
| 20220192860 | Hansen et al. | Jun 2022 | A1 |
| 20220241104 | Knoedler | Aug 2022 | A1 |
| 20220241105 | Hansen et al. | Aug 2022 | A1 |
| 20220265458 | Carlsson et al. | Aug 2022 | A1 |
| Number | Date | Country |
|---|---|---|
| 203786580 | Aug 2014 | CN |
| 104902399 | Sep 2015 | CN |
| 104980878 | Oct 2015 | CN |
| 105588856 | May 2016 | CN |
| 206271160 | Jun 2017 | CN |
| 206450708 | Aug 2017 | CN |
| 3437950 | Apr 1985 | DE |
| 3836590 | May 1990 | DE |
| 19953062 | May 2000 | DE |
| 19900611 | Jul 2000 | DE |
| 102011014321 | Sep 2012 | DE |
| 102011076219 | Nov 2012 | DE |
| 0168967 | Jan 1986 | EP |
| 0373782 | Oct 1994 | EP |
| 0416397 | May 1995 | EP |
| 0800804 | Jun 2003 | EP |
| 1188157 | Dec 2005 | EP |
| 2108345 | Oct 2009 | EP |
| 1275357 | Mar 2011 | EP |
| 2601915 | Jun 2013 | EP |
| 2489561 | Aug 2014 | EP |
| 2654646 | Jul 2016 | EP |
| 3213727 | Dec 2019 | EP |
| 3064179 | Sep 2021 | EP |
| 2219679 | Dec 1989 | GB |
| 2343628 | Oct 2000 | GB |
| 2465742 | Jul 2012 | GB |
| 2542093 | Mar 2017 | GB |
| 2001087299 | Apr 2001 | JP |
| 2002055074 | Feb 2002 | JP |
| 2002224093 | Aug 2002 | JP |
| 2005323981 | Nov 2005 | JP |
| 2014033745 | Feb 2014 | JP |
| 2014054368 | Mar 2014 | JP |
| 20120003987 | Jan 2012 | KR |
| 2527155 | Aug 2014 | RU |
| 201201783 | Jan 2012 | TW |
| 1994015562 | Jul 1994 | WO |
| 1997010012 | Mar 1997 | WO |
| 1999033037 | Jul 1999 | WO |
| 1999036017 | Jul 1999 | WO |
| 2000079497 | Dec 2000 | WO |
| 2001013830 | Mar 2001 | WO |
| 2001050996 | Jul 2001 | WO |
| 2002052302 | Jul 2002 | WO |
| 2002099765 | Dec 2002 | WO |
| 2005082271 | Sep 2005 | WO |
| 2006008866 | Jan 2006 | WO |
| 2006094513 | Sep 2006 | WO |
| 2007000168 | Jan 2007 | WO |
| 2007059774 | May 2007 | WO |
| 2007098762 | Sep 2007 | WO |
| WO-2007098762 | Sep 2007 | WO |
| 2007133555 | Nov 2007 | WO |
| 2008057884 | May 2008 | WO |
| 2009006900 | Jan 2009 | WO |
| 2009052496 | Apr 2009 | WO |
| 2009112912 | Sep 2009 | WO |
| 2011003421 | Jan 2011 | WO |
| 2011004165 | Jan 2011 | WO |
| 2011061540 | May 2011 | WO |
| 2011105701 | Sep 2011 | WO |
| 2011123018 | Oct 2011 | WO |
| 2011139499 | Nov 2011 | WO |
| 2011161254 | Dec 2011 | WO |
| 2012068386 | May 2012 | WO |
| 2012076022 | Jun 2012 | WO |
| 2013013197 | Jan 2013 | WO |
| 2014004207 | Jan 2014 | WO |
| 2014086369 | Jun 2014 | WO |
| 2015007284 | Jan 2015 | WO |
| 2015014774 | Feb 2015 | WO |
| 2015084462 | Jun 2015 | WO |
| 2015094064 | Jun 2015 | WO |
| 2016166731 | Oct 2016 | WO |
| 2017023794 | Feb 2017 | WO |
| 2017062042 | Apr 2017 | WO |
| 2017067558 | Apr 2017 | WO |
| 2017067560 | Apr 2017 | WO |
| 2017088153 | Jun 2017 | WO |
| 2017136696 | Aug 2017 | WO |
| 2017190752 | Nov 2017 | WO |
| 2018028756 | Feb 2018 | WO |
| 2019094635 | May 2019 | WO |
| 2019161863 | Aug 2019 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 20200337880 A1 | Oct 2020 | US |
