Body-wearable device and method for manufacturing a body-wearable device

Abstract

The present invention refers to a body-wearable medical device (110) comprising a base (112) configured for supporting at least one component of the body-wearable medical device (110), a plaster (114) includes a first surface (116) and a second surface (118), where the first surface (116) is arranged opposite to the second surface (118), where the first surface (116) includes an adhesive configured for adhering the plaster (114) to a user's skin, where the second surface (118) of the plaster (114) is, at least in part, laser-welded to the base (112). (Figure 1)

Description

[0001] P39271 -EP

[0002] Roche Diabetes Care GmbH September 26, 2024

[0003] RD39271EP ST / PH

[0004] Body-wearable device and method for manufacturing a body-wearable device

[0005] Technical Field

[0006] The invention relates to a body-wearable medical device and to a method for securely joining a plaster to a base of a body-wearable medical device. Embodiments of the devices and methods as described herein are mainly be used for long-term managing of an analyte concertation in a body fluid, such as for long-term managing of a blood glucose level or of the analyte concentration of one or more other types of analytes in a body fluid. The invention may both be applied in the field of home care as well as in the field of professional care, such as in hospitals. Other applications are feasible.

[0007] Background art

[0008] For body -wearable medical devices, such as a continuous glucose monitoring device and patch pumps, specifically insulin patch pumps, a plaster is affixed to a housing of the bodywearable medical device. The plaster is used for adhering the body-wearable medical device to a patient’s skin. According to the prior art, ultra-sound welding or an adhesive is used for affixing the plaster to the medical device.

[0009] When using ultra-sonic welding, the adhesive surface on the underside of the plaster is typically reduced due to the welding points, which results in a reduction in the holding force on the skin. Sensitive areas on the baseplate, such as the electronics or the predetermined breaking point of the sterile capsule, are also at risk from ultrasonic welding.

[0010] When using an adhesive for adhering the plaster to the medical device, mechanical influences, such as a curvature of an upper arm of the user, or environmental influences, may lead to failure of the adhesive and thus to the body-wearable medical device falling off. P39271 -EP

[0011] Furthermore, when being evenly glued to the medical device, the plaster is less breathable due to the additional layer of adhesive.

[0012] DE 2020 19 005 660 U1 discloses a system for measuring a glucose level comprising: a sensor control device including: an electronics housing comprising: an enclosure having an upper surface with a first opening and a recess defined therein configured to facilitate placement of the electronics housing in at least one degree of freedom, a fixture joined to the enclosure and having a bottom surface with a second opening defined therein aligned with the first opening; a circuit board disposed within the electronics housing and comprising a plurality of electronics modules; a glucose sensor coupled to the circuit board and configured to measure a glucose level; and an adhesive patch attached to the underside of the attachment and configured to attach the sensor control device to a user's skin.

[0013] Problem to be solved

[0014] It is therefore desirable to provide a body-wearable medical device and a method for securely joining a plaster to a base of a body-wearable medical device, which solve at least one of the problems mentioned above.

[0015] In particular, it is desirable to provide a body-wearable medical device and a method for securely joining a plaster to a base of a body- wearable medical device, which offer a reliable fixation of the plaster to the medical device housing without negatively affecting the adherence of the plaster to the body-wearable medical device.

[0016] In particular, it is desirable to provide a body-wearable medical device and a method for securely joining a plaster to a base of a body-wearable medical device, which offer a better heat control during the manufacturing process.

[0017] In particular, it is desirable to provide a body-wearable medical device and a method for securely joining a plaster to a base of a body-wearable medical device, which offer that no or less vibrations may be induced in a housing during a manufacturing process as it would be the case when, exemplarily, using ultra-sound welding.

[0018] Summary

[0019] At least one of the above-mentioned problems is addressed by the body-wearable medical device and by the method for securely joining a plaster to a base of a body-wearable medical P39271 -EP device with the features of the independent claims. Embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

[0020] In a first aspect, a body- wearable medical device is disclosed. For this aspect, reference may be made to any disclosure herein, particularly to any definition, Embodiment and / or further aspect as disclosed elsewhere herein. The body- wearable medical device comprises:

[0021] - a base, preferably configured for supporting at least one component of the bodywearable medical device,

[0022] - a plaster comprising a first surface and a second surface, wherein the first surface is arranged opposite to the second surface, wherein the first surface comprises an adhesive configured for adhering the plaster to a user’s skin, wherein the second surface of the plaster is, at least in part, laser-welded to the base.

[0023] The term "body-wearable" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refer, without limitation, to a device configured for being in contact with the body of the user, particularly during an active wear time of the device. During the active wear time, the device provides a medical or health functionality. The device is configured to be mounted on a skin site of a body part. For example, the skin site of the body part can be selected from the group consisting of: an arm, exemplarily an upper arm; a stomach; a shoulder; a back; hip; a leg. Specifically, the device comprises a plaster that comprises an adhesive surface for attachment to the user’s skin.

[0024] The term "medical device" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to an arbitrary element or article being configured for use in the field of health care and medical technology, exemplarily in the field of medical analytics or medical diagnostics. The medical device may be configured for performing a medical function and / or for being used in a medical process, such as in one or more of a therapeutic process, a diagnostic process or another medical process. The medical device can be configured to provide or manage health parameters of a user of the medical device.

[0025] The term "base" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a P39271 -EP special or customized meaning. The term refers, without limitation, to a component of a device upon which at least one further component is securely fixed to a user’s body. The base may be configured for providing stability and support to the device. The base may be a component of the housing of the device, which is enclosing the further components of the device. The base may be a base portion of the device. The base may be a base plate.

[0026] The term "component" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term refers, without limitation, to an individual part and / or element that contributes to the functionality of the device. A specific component may offer a specific functionality for the device. A specific component may be physically separable from at least one further component of the device.

[0027] The term "plaster" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term refers, without limitation, to an strip or portion configured for adhering to the user's skin. Adhering to the user's skin may be in order to bind the medical device to the user's skin to resist separation.

[0028] The term "user" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term refers, without limitation, to a person wearing the body-wearable medical device. For example, the user may be a patient suffering from a disease, such as diabetes. The user may also be referred to as subject or as patient. The term may also refer, without limitation, to a person intended to monitor and / or control at least one analyte value, such as a glucose value, in a person’s body tissue.

[0029] The term "first surface" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term refers, without limitation, to an external and / or an outermost layer of a component that forms an interface of the component to a surrounding. The surrounding may be a further component or device and / or the environment. The first surface may be opposite to the second surface in relation to the plaster. The first surface may be an adhesive surface, particularly because it comprises an adhesive or is formed from an adhesive. The term “adhesive surface” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of P39271 -EP ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a surface being capable to bind to an object and to resist separation. Exemplarily, the adhesive surface may be comprised be a plaster. The first surface may be configured to abut the user during the active wear time.

[0030] The term "second surface" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an external and / or an outermost layer of a component that forms an interface of the component to a surrounding. The surrounding may be a further component or device and / or the environment. The second surface is at least in part laser-welded to the base. The second surface may abut the base. The second surface is opposite to the first surface in relation to the plaster.

[0031] The term "adhesive" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a substance configured for bonding and / or joining at least two surfaces together in order to form a strong and durable connection in order to resist separation of the surfaces. For adhering the at least two surfaces a molecular bond and / or an electrostatic bond and / or a mechanical bond between the adhesive and each surface of the at least two surfaces is generated.

[0032] The term "laser-welding" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a welding technique that uses at least one laser beam to fuse and join at least two materials together, such as metals and / or thermoplastics. The laser may be used as a heat source in order to melt the at least two materials at the joint and, thereby, allowing them to fuse together while they cool and solidify.

[0033] The term "laser" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a device configured to emit a coherent beam of light through the process of optical amplification. P39271 -EP

[0034] The laser may emit light having a wavelength range between 0,75 gm and 11 gm. The laser may emit light having an intensity between 0.1 Watt and 1000 Watt.

[0035] After being laser welded, the adhesive of the first surface of the plaster is free of defects having a reduced adhesive force, preferably wherein the adhesive of the first surface is free of the defects having the reduced adhesive force that are caused by a process of securely joining the base to the plaster. “Free of defects” refers to less or significantly less defects when compared to a method for securing a plaster to a medical device that uses ultra-sound welding.

[0036] The term "defect" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to an imperfection, flaw and / or abnormality in an object that deviates from its intended design or function. A defect may be caused in the manufacturing process of the device.

[0037] In the process of laser-welding the second surface of the plaster, at least in part, to the base the first surface of the plaster may stay intact in a manner that it is free of defects that may cause a reduction of the adhesive force. The first surface of the plaster may, consequently, provide a consistent adhesive strength over the entire first surface, preferably when it is adhered to the user's skin. The adhesive strength across the entire first surface may be uniform, preferably when it is adhered to the user's skin.

[0038] In one or more joint areas at which the second surface of the plaster and the base are laser-welded together, the material of the second surface of the plaster and the material of the base are thermally welded.

[0039] The term "joint area" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a region at which the base is laser- welded to the plaster. Each joint area of the one or more joint areas may be, at least in part, preferably fully, encompassed by a distinct absorption area.

[0040] The term "thermally welded" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be P39271 -EP limited to a special or customized meaning. The term specifically refers, without limitation, to a process in which two or more materials are fused together using heat.

[0041] The plaster may comprise a plaster body and one or more distinct absorption areas, wherein, preferably each of, the one or more distinct absorption areas of the plaster comprise at least one additive having an absorption coefficient larger than the plaster body for light irradiated by a laser, which is used for laser-welding the second surface of the plaster to the base, preferably and wherein the one or more distinct absorption areas of the plaster abut against the base.

[0042] The term “plaster body" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a primary structure of the plaster upon which additional components are attached or integrated. The plaster body is configured for supporting at least one further structure of the plaster, such as the one or more distinct absorption areas. The one or more distinct absorption areas may be arranged on or integrated into the plaster body. The one or more distinct absorption areas may be, preferably at least in part or fully, enclosed by the plaster body.

[0043] The term "distinct absorption area" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a closed region having a specific absorption coefficient. The absorption coefficient may be selected in a manner that the absorption of the light emitted by the laser in the laser-welding process is enhanced. As a result, the absorption coefficient may be increased when compared to the remaining plaster and / or the remaining base. Preferably, the absorption coefficient may be increased when compared to plaster body and / or the base body, respectively. In case the absorption coefficient is increased, the absorption coefficient may be at least in the range between 0.1 and 10 times larger compared to the remaining plaster and / or the remaining base, respectively. In case the absorption coefficient is increased, the absorption coefficient may be at least in the range between 0.1 and 10 times larger compared to the plaster body and / or the base body, respectively. In case the plaster and the base each comprise one or more distinct absorption areas, distinct absorption areas of the base and distinct absorption areas of the plaster may abut each other, particularly during and after the laser-welding process. P39271 -EP

[0044] The term "additive" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to one or more substances that are added to a material in order to adjust a at least one specific characteristic of the material. The additive may be introduced onto the plaster and / or the base in order to adjust the absorption coefficient of at the area at which the material is introduced.

[0045] The term "absorption coefficient" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term refers, without limitation, to a measure of how effectively a material absorbs light passing through the material. The absorption coefficient quantifies how much light is absorbed per unit distance as the light travels through the material.

[0046] The one or more distinct absorption areas of the plaster comprise at least one additive having an absorption coefficient larger than the plaster body for light irradiated by a laser, which is used for laser-welding the second surface of the plaster to the base. Alternatively or in addition, the one or more distinct absorption areas of the base comprise at least one additive having an absorption coefficient larger than the base body for the light irradiated by the laser, which is used for laser-welding the second surface of the plaster to the base. In this context, the light irradiated by the laser may have a wavelength between 0,75 pm and 11 pm. The absorption coefficient may be defined for these wavelength.

[0047] The adhesive of the first surface is free of defects having a reduced adhesive force in the one or more joint areas at which the second surface of the plaster and the base are laser-welded together, preferably wherein the adhesive of the plaster is free of the defect having the reduced adhesive force in the one or more joint areas at which the second surface of the plaster and the base are laser-welded together that are caused by a process of securely joining the base to the plaster.

[0048] The term "adhesive force" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to an attraction between the particles or molecules of different substances that act to hold P39271 -EP them together. The adhesive force may be the attractive force that causes the bonded and / or joined at least two surfaces together.

[0049] The term "securely joining" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to the act of connecting or fastening two or more components in a manner that ensures stability, strength and / or reliability. When two components are securely joined, they are firmly attached to each other, minimizing the risk of separation or failure even under stress or external forces. For securely joining the base and the plaster, the plaster and the base are laser- welded together. The secure joint may then be the result of the laserwelding process.

[0050] An amount of the at least one additive of the one or more distinct absorption areas of the plaster may be further selected in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is in accordance with a melting point of at least one of: the plaster, the base.

[0051] The term "target temperature" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a specific temperature that is achieved in the laser-welding process in order to trigger that the material melts. The target temperature may be selected in accordance with the melting point. For the target temperature being selected in accordance with the melting point, the target temperature may equal or may be above the melting point.

[0052] The term "melting point" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a temperature at which a material melts, such as by changing from a solid to a liquid state. The melting temperature may depend on the material. In the laser-welding process, the laser is used to heat at least one material to reach its melting point in order to trigger that the material melts. Preferably the at least two materials at the joint are heated above their respective temperature such that the materials can fuse together. Consequently, the base or the plaster, preferably the base and the plaster, may be heated by the laser in the laser-welding process in a manner that the base or the plaster, preferably the base and the plaster, reach the melting point. P39271 -EP

[0053] The at least one additive of the one or more distinct absorption areas of the plaster, is selected from at least one of:

[0054] - a color pigment, such as red, green, blue;

[0055] - a filler material, such as glass fiber, particularly woven glass fiber;

[0056] - a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

[0057] The term "color pigment" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a chemical substance configured to set a color of a material into which the color pigment is introduced by selectively absorbing and reflecting specific wavelengths of light. A color pigment may be or may comprise one or more particles and / or one or more chemical compounds. A color pigment may be an organic color pigment and / or an inorganic color pigment.

[0058] The term "filler material" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to an material having an increased absorption coefficient for the light emitted by the laser in the laser-welding process when compared to the remaining element into which the filler material is introduced, such as the remaining plaster or the remaining base.

[0059] The term "woven glass fiber" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a lightweight and durable synthetic material composed of extremely fine fibers of glass that are woven. Preferably the woven glass fiber may be incorporated into the plaster.

[0060] The term "semi-crystalline structure" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a specific atomic and / or molecular arrangement of a materials in which crystalline and amorphous regions coexist. In a semi-crystalline material, at least one portion of the material exhibits an ordered atomic and / or molecular arrangement that is P39271 -EP characteristic of crystals, while at least one further portion of the material exhibits random atomic and / or molecular arrangement that is characteristic of amorphous materials.

[0061] The one or more distinct absorption areas of the plaster may be on / in the second surface of the plaster and / or the plaster body. The one or more distinct absorption areas of the plaster may be arranged in at least one pattern, particularly in a manner that the one or more distinct absorption areas lie on a circle.

[0062] The term "pattern" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a specific arrangement elements that repeat in a systematic or organized manner.

[0063] The base may comprise a base body and one or more distinct absorption areas, wherein, specifically each of, the one or more distinct absorption areas of the base comprise at least one additive having an absorption coefficient larger than the base body for the light irradiated by the laser, which is used for laser-welding the second surface of the plaster to the base, particularly and wherein the one or more distinct absorption areas of the base abut against the second surface of the plaster.

[0064] The term "base body" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a primary structure of the base upon which additional components are attached or integrated. The base body is configured for supporting at least one further structure of the base such as the one or more distinct absorption areas. The one or more distinct absorption areas may be arranged on or integrated into the base body. The one or more distinct absorption areas may be, preferably at least in part or fully, enclosed by the base body.

[0065] A material of the base body may be or may comprise at least one or more of:

[0066] - Polycarbonat (PC); and

[0067] - Polypropylen (PP).

[0068] An amount of the at least one additive of the one or more distinct absorption areas of the base is further selected in accordance with a target temperature to be achieved when P39271 -EP performing the laser-welding, wherein the target temperature is selected in accordance with a melting point of at least one of: the plaster, the base.

[0069] The at least one additive of the one or more distinct absorption areas of the base may be selected from at least one of:

[0070] - a color pigment, such as red, green, blue;

[0071] - a filler material, such as glass fiber, particularly woven glass fiber;

[0072] - a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

[0073] The one or more distinct absorption areas of the base may be arranged in at least one pattern, particularly in a manner that the one or more distinct absorption areas of the base lie on a circle.

[0074] The plaster may comprise a passage opening, preferably for a protruding element comprised by the body-wearable medical device that is protruding from the base through the passage opening.

[0075] The term "passage opening" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to an opening within a component that is configured in a manner that a further component can protrude through the opening in order to allow passage of the further component from a first side of the component to a second side of the component. The passage opening may be or may form a tunnel. Consequently, the passage opening may be a tunnel opening.

[0076] The term "protruding element" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a component of the body-wearable medical device that is protruding from the base through the passage opening. The protruding element may be attached to or integrated in the base. Consequently, the protruding element may be fixed to base. Thereby, the base may support the protruding element.

[0077] The protruding element is selected from at least one of:

[0078] - an analyte sensor assembly;

[0079] - a cannula, preferably a soft cannula or steel cannula, P39271 -EP a tubing.

[0080] The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to an arbitrary element, component or compound which may be present in a body fluid. A presence and / or a concentration of the analyte may be of interest for a user, a patient or medical staff such as for a medical doctor. Particularly, the analyte may be or may comprise an arbitrary chemical substance or chemical compound which may take part in a metabolism of the user or the patient, such as a metabolite. As an example, the analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, lactate. Additionally or alternatively, however, other types of analytes may be used and / or any combination of analytes may be determined. However, preferably, the analyte may be glucose.

[0081] The term “analyte sensor assembly” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a sensor which is capable of qualitatively or quantitatively detecting a presence and / or a concentration of an analyte.

[0082] The term “detecting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a process of determining a presence and / or a quantity and / or a concentration of an analyte. Thus, the detection may be or may comprise a qualitative detection, simply determining the presence of the analyte or the absence of the analyte, and / or may be or may comprise a quantitative detection, which determines the quantity and / or the concentration of the analyte. As a result of the detection, a signal may be produced which characterizes an outcome of the detection, such as at least one measurement signal. The measurement signal specifically may be or may comprise an electronic signal such as a voltage and / or a current. The measurement signal may be or may comprise an analogue signal and / or may be or may comprise a digital signal.

[0083] The analyte sensor assembly, preferably, may be or comprise a transcutaneous sensor. The transcutaneous sensor may be an electrochemical analyte sensor. The term “transcutaneous sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited P39271 -EP to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary sensor which is adapted to be fully or at least partly arranged within a body tissue of a patient or a user. For this purpose, the analyte sensor comprises the insertable portion. The transcutaneous sensor may be protruding through the plaster. The term “insertable portion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a part or component of an element configured to be insertable into an arbitrary body tissue. The transcutaneous sensor may fully or partially provide a biocompatible surface, i.e. a surface which, at least during durations of use, do not have any detrimental effects on the user, the patient or the body tissue. Preferably, the insertable portion of the transcutaneous sensor may have a biocompatible surface. As an example, the transcutaneous sensor, specifically the insertable portion, may fully or partially be covered with a biocompatible membrane, such as a polymer membrane or gel membrane which is permeable for the analyte and / or the body fluid and which, on the other hand, retains sensor substances such as one or more analyte detection agents within the sensor and prevents a migration of these substances into the body tissue. Other parts or components of the transcutaneous sensor may stay outside of the body tissue. The other parts may be connectable to an evaluation device such as to the electronics units of the body-wearable medical device.

[0084] The analyte sensor assembly, preferably, may be or comprise the electrochemical analyte sensor. The electrochemical analyte sensor may be the transcutaneous sensor. The term “electrochemical sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a sensor which is configured to conduct an electrochemical measurement, specifically in order to detect an analyte in a body fluid of a user. The term “electrochemical measurement” may refer to a detection of an electrochemically detectable property of the analyte, such as to an electrochemical detection reaction. Thus, for example, the electrochemical detection reaction may be detected by comparing one or more electrode potentials. The electrochemical sensor specifically may be adapted to and / or may be usable to generate an electrical sensor signal which directly or indirectly indicates the presence and / or the extent of the electrochemical detection reaction, such as a current and / or a voltage. The detection may be analyte-specific. The measurement may be a qualitative and / or a quantitative measurement. Still, further embodiments are feasible. P39271 -EP

[0085] The term "cannula" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow needle which may be at least partially or completely slotted. The analyte sensor assembly may, at least in part, be received within the cannula, such as within a lumen of the cannula. The cannula may comprise a tip or a sharp end for inserting the analyte sensor assembly at least partially into the body tissue. The cannula e.g. may comprise at least one cross-section selected from the group consisting of: round, elliptical, U shaped, V shaped. Still, other embodiments are feasible. Preferably, the insertion cannula may be a slotted cannula. Alternatively, the insertion cannula may be a nonslotted cannula. The insertion cannula may be configured to be inserted vertically or at an angle of 90° to 30° relative to the body tissue of the user. The cannula may be insertable at least partially into the body tissue, particularly in order to deliver or to transfer a further element, such as the analyte sensor assembly. The analyte sensor assembly, preferably the transcutaneous sensor and / or the electrochemical analyte sensor, may be, at least partially, arranged inside the cannula.

[0086] The term "tubing" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow cylindrical structure or pipe.

[0087] The at least one pattern related to the one or more distinct absorption areas of the plaster may be surrounding the passage opening. Alternatively or in addition, the at least one pattern related to the one or more distinct absorption areas of the base may be surrounding the passage opening.

[0088] The base may be at least partially transparent for the light emitted by the laser, which is used for laser-welding the second surface of the plaster to the base, preferably wherein the base has a transmission coefficient of at least in the range between 0.1 and 0.9 for the light emitted by the laser.

[0089] The term "transmission coefficient" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a measure of how effectively a material transmits light passing through P39271 -EP the material. The transmission coefficient may quantify how much light is transmitted per unit distance as the light travels through the material.

[0090] The base may comprise the base body and at least one laser window, wherein the at least one laser window has a higher transmission coefficient than the base body for the light emitted by the laser, which is used for laser-welding the second surface of the plaster to the base.

[0091] The term "laser window" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to a closed region having a specific absorption coefficient. The absorption coefficient may be selected in a manner that the absorption of the light emitted by the laser in the laserwelding process is decreased. As a result, the absorption coefficient may be decreased when compared to the further components of the base. The absorption coefficient of the laser window may be in the range between 0.1 and 10 times smaller compared to the remaining base. The absorption coefficient of the laser window may be in the range between 0.1 and 10 times smaller compared to the base body. Each laser window of the at least one laser window may abut the distinct absorption areas of the base and / or the distinct absorption areas of the plaster.

[0092] The adhesive may be configured for adhering the body-wearable medical device to the user’s skin may be a biocompatible adhesive. The adhesive configured for adhering the body-wearable medical device to the user’s skin is a heat-resistant adhesive.

[0093] The body- wearable medical device may be selected from at least one of:

[0094] - a continuous analyte monitoring device, specifically a glucose monitoring device;

[0095] - a fluid delivery device, in particular an insulin infusion pump.

[0096] The continuous analyte monitoring device may comprise a housing comprising an electronics unit received therein. The housing comprising the electronics unit may be configured to stay outside of the body tissue. The term “housing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which is adapted to fully or partially surround and / or receive one or more elements in order to provide one or more of a mechanical P39271 -EP protection, a mechanical stability, an environmental protection against moisture and / or ambient atmosphere, a shielding against electromagnetic influences or the like. Thus, the housing may simply provide a basis for attachment and / or holding one or more further components or elements. Additionally or alternatively, the housing may provide one or more interior spaces for receiving one or more further components or elements. The housing may specifically be manufactured by injection molding. However, other embodiments are feasible. Exemplarily, the electronics unit may be sealed or potted as will further be described below.

[0097] The term “electronics unit” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary device, which is configured for performing at least one electronic function. Specifically, the electronics unit may have an electronic component. Specifically, the electronics unit may comprise the electronic component for one or more of performing a measurement with the analyte sensor, performing a voltage measurement, performing a current measurement, recording sensor signals, storing measurement signals or measurement data, transmitting sensor signals or measurement data to another device. The electronics unit may specifically be embodied as a transmitter or may comprise a transmitter, for transmitting data. Other embodiments of the electronic components are feasible. These electronic components generally are known in the art of long-term monitoring one or more analytes, such as in from one or more of the above-mentioned prior art documents.

[0098] The continuous analyte monitoring device may comprise the protruding element, preferably, the analyte sensor assembly; the cannula, preferably the soft cannula or the steel cannula, and / or the tubing.

[0099] The term "fluid delivery device" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to an arbitrary device configured for administering the user a fluid, such as insulin, preferably by using at least one pump.

[0100] The fluid delivery device may comprise the protruding element, preferably, the analyte sensor assembly, the cannula, preferably the soft cannula or the steel cannula, and / or the tubing. P39271 -EP

[0101] In a further aspect, a method for securely joining a plaster to a base of a body- wearable medical device, preferably wherein the base is configured for supporting at least one component of the body-wearable medical device, wherein the plaster comprises a first surface and a second surface, wherein the first surface is arranged opposite to the second surface, wherein the first surface comprises an adhesive configured for adhering the to a user’s skin, is disclosed. For this aspect, reference is made to any disclosure herein, particularly to any definition, Embodiment and / or further aspect as disclosed elsewhere herein.

[0102] The method for securely joining a plaster to a base of a body- wearable medical device may comprise the following steps, which may be performed in the given order. A different order, however, may also be feasible. Further, two or more of the method steps may be performed simultaneously. Thereby, the method steps may at least partly overlap in time. Further, the method steps may be performed once or repeatedly. Thus, one or more or even all of the method steps may be performed once or repeatedly. The method may comprise additional method steps, which are not listed herein.

[0103] The method comprises:

[0104] - laser-welding the second surface of the plaster to the base by using a laser.

[0105] The plaster may comprise a plaster body and one or more distinct absorption areas, wherein, preferably each of, the one or more distinct absorption areas of the plaster comprise at least one additive having an absorption coefficient for light irradiated by the laser larger than the plaster body, preferably and wherein the one or more distinct absorption areas of the plaster abut against the base, the method comprising:

[0106] - selecting an amount of the at least one additive of the distinct absorption areas of the plaster in accordance with a target temperature to be achieved when performing the laser welding, wherein the target temperature is in accordance with a melting point of at least one of: the plaster, the base.

[0107] The term "selecting" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to the process of choosing a specific item from a set comprising a plurality of items. For selecting the amount of the at least one additive of the distinct absorption areas of the plaster in accordance with a target temperature to be achieved when performing the laser welding, the selection may be based on at least one characteristic of the laser, such as P39271 -EP the intensity and / or the wavelength, and / or the absorption coefficient of the distinct absorption areas.

[0108] The base may comprises a base body and one or more distinct absorption areas, wherein, specifically each of, the one or more distinct absorption areas of the base comprise at least one additive having an absorption coefficient for the light irradiated by the laser larger than the base body, particularly and wherein the one or more distinct absorption areas of the base abut against the second surface of the plaster, the method comprising:

[0109] - selecting an amount of the at least one additive of the distinct absorption areas of the base in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is selected in accordance with a melting point of at least one of: the plaster, the base.

[0110] For selecting the amount of the at least one additive of the distinct absorption areas of the base in accordance with a target temperature to be achieved when performing the laser welding, the selection may be based on at least one characteristic of the laser, such as the intensity and / or the wavelength, and / or the absorption coefficient of the distinct absorption areas.

[0111] Laser-welding the second surface of the plaster to the base by using a laser may comprise

[0112] - pressing the plaster and the base against each other while the plaster and the base are joined by laser-welding, particularly by using at least one of: a clamp; a fixture; a press.

[0113] The term "pressing" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to the process of applying a force onto at least two objects, such as the plaster and the base, in order to bring them into contact and maintain that contact. Pressing may involve increasing the force between the two objects.

[0114] Laser-welding the second surface of the plaster to the base by using a laser may comprise

[0115] - irradiating, particularly exclusively, at least one of: the one or more distinct absorption areas on the plaster; the one or more distinct absorption areas on the base by using the laser in a manner that the plaster and the base are joined by laser-welding. P39271 -EP

[0116] The term "irradiating" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers, without limitation, to the process of using a light source, preferably a laser, to apply electromagnetic radiation onto a material or target.

[0117] Laser-welding the second surface of the plaster to the base by using a laser may be performed in a manner that the light emitted by the laser traverses through the base before impinging on the second surface of the plaster.

[0118] The base may comprise at least one laser window, wherein the at least one laser window has a higher transmission coefficient than the base body for the light emitted by the laser, wherein laser-welding the second surface of the plaster to the base by using a laser is performed in a manner that the light emitted by the laser traverses through the at least one laser window.

[0119] Laser-welding the second surface of the plaster to the base by using a laser may comprise

[0120] - cooling at least one of: the plaster; the base, when the plaster and the base are joined by laser- welding, particularly by using at least one of: a cooling device, a cooling as part of a clamping and / or fixture, a contact cooling, an air cooling.

[0121] According to an embodiment, laser-welding the second surface of the plaster to the base by using a laser is performed by using ultra short-light pulses, such as femtosecond light pulses or attosecond light pulses.

[0122] The body-wearable medical device may be a body-wearable medical device as elsewhere disclosed herein.

[0123] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides P39271 -EP

[0124] B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0125] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

[0126] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0127] The proposed body-wearable medical device and the proposed method for securely joining a plaster to the base of the body-wearable medical device provide many advantages over known devices and methods.

[0128] The proposed body-wearable medical device and the proposed method for securely joining a plaster to a base of a body- wearable medical device provide may offer a reliable fixation of the plaster to the medical device housing without negatively affecting the adherence of the plaster to the body-wearable medical device.

[0129] Further advantages of the proposed body-wearable medical device and of the proposed method for securely joining a plaster to a base of a body- wearable medical device may be a better heat control during the manufacturing process. P39271 -EP

[0130] Further advantages of the proposed body-wearable medical device and of the proposed method for securely joining a plaster to a base of a body- wearable medical device may be that no vibrations may be induced to the housing during the manufacturing process as it would be the case when using ultra-sound welding.

[0131] The body- wearable medical device may be described by using the following words:

[0132] Body-wearable medical device comprising:

[0133] - a medical device base portion,

[0134] - a plaster comprising a first surface and a second surface, wherein the first surface is arranged on a side of the plaster opposite to the second surface, the first surface comprises an adhesive configured for adhering the bodywearable medical device to a user’s skin, wherein the second surface of the plaster is, at least in part, laser-welded to the medical device base portion.

[0135] The laser-light may have an optimized absorption rate in respect to the material of base plate. A welding pattern may be used. Additives may be incorporated into the base and / or the plaster being optimized for the laser-welding process.

[0136] Instead of using an adhesive or common welding techniques, such as ultra-sound welding, the plaster may be securely joined to the base of the medical device by laserwelding. Laser welding is intended to create a strong bond that is less susceptible to environmental influences than the known chemical bonds. The laser- welding process enables plastics to be joined with a minimal influence on the plastic components. By selecting a suitable material and applying the right amount of energy, the plaster and base can be joined without damaging the bonded surface of the plaster due to overheating. It may be also possible to use cooling mechanisms on the patch to reduce temperature effects of the laser on the adhesive surface.

[0137] The base may have or may comprise a transparent material, which benefits the laserwelding process. Further, additives may be introduced in the plaster and / or the baser in order to increase the absorption of the laser light. These may be or may comprise additives color pigment, such as red, green, blue; a filler material, such as glass fiber, particularly woven glass fiber; and / or a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT). The add These are placed on the plaster in a targeted manner, e.g. in the form of colored dots, to create specific welding points. The plaster may only be welded to the plastic sheet at these specific welding points. P39271 -EP

[0138] A further laser welding process may be "localized welding with ultrashort laser pulses". Here, many laser pulses are emitted very precisely at a local point in a few fractions of a second. The ultrashort pulses offer the advantage of minimizing the thermal stresses in the material and thus leaving the baseplate and the adhesive surface on the underside unchanged

[0139] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0140] Embodiment 1 : A body-wearable medical device comprising:

[0141] - a base, preferably configured for supporting at least one component of the body-wearable medical device,

[0142] - a plaster comprising a first surface and a second surface, wherein the first surface is arranged opposite to the second surface, wherein the first surface comprises an adhesive configured for adhering the plaster to a user’s skin, wherein the second surface of the plaster is, at least in part, laser-welded to the base.

[0143] Embodiment 2: The body-wearable medical device according to the Embodiment 1, wherein the adhesive of the first surface is free of defects having a reduced adhesive force, preferably wherein the adhesive of the first surface is free of the defect having the reduced adhesive force that are caused by a process of securely joining the base to the plaster.

[0144] Embodiment 3: The body-wearable medical device according to any one of Embodiment 1 or 2, wherein in one or more joint areas at which the second surface of the plaster and the base are laser-welded together, the material of the second surface of the plaster and the material of the base are thermally welded.

[0145] Embodiment 4: The body-wearable medical device of any one of Embodiments 1 to 3, wherein the plaster comprises a plaster body and one or more distinct absorption areas, wherein, preferably each of, the one or more distinct absorption areas of the plaster comprise at least one additive having an absorption coefficient larger than the plaster body for light irradiated by a laser, which is used for laser-welding the P39271 -EP second surface of the plaster to the base, preferably and wherein the one or more distinct absorption areas of the plaster abut against the base.

[0146] Embodiment 5: The body-wearable medical device according to the Embodiment 4, wherein the adhesive of the first surface is free of defects having a reduced adhesive force in the one or more joint areas at which the second surface of the plaster and the base are laser-welded together, preferably wherein the adhesive of the plaster is free of the defect having the reduced adhesive force in the one or more joint areas at which the second surface of the plaster and the base are laser- welded together that are caused by a process of securely joining the base to the plaster.

[0147] Embodiment 6: The body-wearable medical device according to the Embodiment 4 or 5, wherein a material of the plaster body is or comprises at least one or both of:

[0148] - Polycarbonat (PC); and

[0149] - Polypropylen (PP).

[0150] Embodiment 7: The body- wearable medical device according to the any one of Embodiments 4 to 6, wherein an amount of the at least one additive of the one or more distinct absorption areas of the plaster is further selected in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is in accordance with a melting point of at least one of: the plaster, the base.

[0151] Embodiment 8: The body-wearable medical device according to the Embodiment 7, wherein the at least one additive of the one or more distinct absorption areas of the plaster, is selected from at least one of:

[0152] - a color pigment, such as red, green, blue;

[0153] - a filler material, such as glass fiber, particularly woven glass fiber;

[0154] - a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

[0155] Embodiment 9: The body- wearable medical device according to the any one of Embodiments 4 to 8, wherein the one or more distinct absorption areas of the plaster are on the second surface of the plaster. P39271 -EP

[0156] Embodiment 10: The body-wearable medical device according to the any one of Embodiments 4 to 9, wherein the one or more distinct absorption areas of the plaster are arranged in at least one pattern, particularly in a manner that the one or more distinct absorption areas lie on a circle.

[0157] Embodiment 11 : The body-wearable medical device according to the any one of Embodiments 1 to 10, wherein the base comprises a base body and one or more distinct absorption areas, wherein, specifically each of, the one or more distinct absorption areas of the base comprise at least one additive having an absorption coefficient larger than the base body for the light irradiated by the laser, which is used for laser-welding the second surface of the plaster to the base, particularly and wherein the one or more distinct absorption areas of the base abut against the second surface of the plaster.

[0158] Embodiment 12: The body- wearable medical device according to the Embodiment 11, wherein a material of the base body is or comprises at least one or both of:

[0159] - Polycarbonat (PC); and

[0160] - Polypropylen (PP).

[0161] Embodiment 13: The body-wearable medical device according to the Embodiment 11 or 12, wherein an amount of the at least one additive of the one or more distinct absorption areas of the base is further selected in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is selected in accordance with a melting point of at least one of: the plaster, the base.

[0162] Embodiment 14: The body-wearable medical device according to the any one of Embodiments 11 to 13 , wherein the at least one additive of the one or more distinct absorption areas of the base is selected from at least one of:

[0163] - a color pigment, such as red, green, blue;

[0164] - a filler material, such as glass fiber, particularly woven glass fiber;

[0165] - a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

[0166] Embodiment 15: The body-wearable medical device according to the any one of

[0167] Embodiments 11 to 14, wherein the one or more distinct absorption areas of the P39271 -EP base are arranged in at least one pattern, particularly in a manner that the one or more distinct absorption areas of the base lie on a circle.

[0168] Embodiment 16: The body-wearable medical device according to the any one of Embodiments 1 to 15, wherein the plaster comprises a passage opening, preferably for an protruding element comprised by the body-wearable medical device that is protruding from the base through the passage opening.

[0169] Embodiment 17: The body- wearable medical device according to the Embodiment 16, wherein the protruding element is selected from at least one of:

[0170] - an analyte sensor assembly;

[0171] - a cannula, preferably a soft cannula or steel cannula,

[0172] - a tubing.

[0173] Embodiment 18: The body-wearable medical device according to Embodiment 16 or 17, wherein the at least one pattern related to the one or more distinct absorption areas of the plaster are surrounding the passage opening.

[0174] Embodiment 19: The body-wearable medical device according to the any one of Embodiments 16 to 18, wherein the at least one pattern related to the one or more distinct absorption areas of the base are surrounding the passage opening.

[0175] Embodiment 20: The body-wearable medical device according to the any one of Embodiments 1 to 19, wherein the base is at least partially transparent for the light emitted by the laser, which is used for laser-welding the second surface of the plaster to the base, preferably wherein the base has a transmission coefficient of at least 0.1 to 0.9 for the light emitted by the laser.

[0176] Embodiment 21 : The body-wearable medical device according to the any one of Embodiments 1 to 20, wherein the base comprises the base body and at least one laser window, wherein the at least one laser window has a higher transmission coefficient than the base body for the light emitted by the laser, which is used for laser-welding the second surface of the plaster to the base. P39271 -EP

[0177] Embodiment 22: The body-wearable medical device according to any one of Embodiments 1 to 21, wherein the adhesive configured for adhering the bodywearable medical device to the user’s skin is a biocompatible adhesive.

[0178] Embodiment 23: The body-wearable medical device according to any one of Embodiments 1 to 22, wherein the adhesive configured for adhering the bodywearable medical device to the user’s skin is a heat-resistant adhesive.

[0179] Embodiment 24: The body-wearable medical device according to the any one of Embodiments 1 to 23, wherein the body- wearable medical device is selected from at least one of:

[0180] - a continuous analyte monitoring device, specifically a glucose monitoring device;

[0181] - a fluid delivery device, in particular an insulin infusion pump.

[0182] Embodiment 25: A method for securely joining a plaster to a base of a body-wearable medical device, preferably wherein the base is configured for supporting at least one component of the body-wearable medical device, wherein the plaster comprises a first surface and a second surface, wherein the first surface is arranged opposite to the second surface, wherein the first surface comprises an adhesive configured for adhering the to a user’s skin, the method comprising:

[0183] - laser-welding the second surface of the plaster to the base by using a laser.

[0184] Embodiment 26: The method according to Embodiment 25, wherein the plaster comprises a plaster body and one or more distinct absorption areas, wherein, preferably each of, the one or more distinct absorption areas of the plaster comprise at least one additive having an absorption coefficient for light irradiated by the laser larger than the plaster body, preferably and wherein the one or more distinct absorption areas of the plaster abut against the base, the method comprising:

[0185] - selecting an amount of the at least one additive of the distinct absorption areas of the plaster in accordance with a target temperature to be achieved when performing the laser welding, wherein the target temperature is in accordance with a melting point of at least one of: the plaster, the base.

[0186] Embodiment 27: The method according to Embodiment 25 or 26, wherein the base comprises a base body and one or more distinct absorption areas, wherein, P39271 -EP specifically each of, the one or more distinct absorption areas of the base comprise at least one additive having an absorption coefficient for the light irradiated by the laser larger than the base body, particularly and wherein the one or more distinct absorption areas of the base abut against the second surface of the plaster, the method comprising:

[0187] - selecting an amount of the at least one additive of the distinct absorption areas of the base in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is selected in accordance with a melting point of at least one of: the plaster, the base.

[0188] Embodiment 28: The method according to any one of the any one of any one of Embodiments 25 to 27, wherein laser-welding the second surface of the plaster to the base by using a laser comprises

[0189] - pressing the plaster and the base against each other while the plaster and the base are joined by laser-welding, particularly by using at least one of: a clamp; a fixture; a press;

[0190] Embodiment 29: The method according to any one of Embodiments 25 to 28, wherein laser-welding the second surface of the plaster to the base by using a laser comprises

[0191] - irradiating, particularly exclusively, at least one of: the one or more distinct absorption areas on the plaster; the one or more distinct absorption areas on the base by using the laser in a manner that the plaster and the base are joined by laser-welding.

[0192] Embodiment 30: The method according to any one of Embodiments 25 to 29, wherein laser-welding the second surface of the plaster to the base by using a laser is performed in a manner that the light emitted by the laser traverses through the base before impinging on the second surface of the plaster.

[0193] Embodiment 31 : The method according to any one of Embodiments 25 to 30, wherein the base comprises at least one laser window, wherein the at least one laser window has a higher transmission coefficient than the base body for the light emitted by the laser, wherein laser-welding the second surface of the plaster to the base by using a laser is performed in a manner that the light emitted by the laser traverses through the at least one laser window. P39271 -EP

[0194] Embodiment 32: The method according to any one of Embodiments 25 to 31, wherein laser-welding the second surface of the plaster to the base by using a laser comprises

[0195] - cooling at least one of: the plaster; the base, when the plaster and the base are joined by laser-welding, particularly by using at least one of: a cooling device, a cooling as part of a clamping and / or fixture, a contact cooling, an air cooling.

[0196] Embodiment 33 : The method according to any one of Embodiments 25 to 32, wherein laser-welding the second surface of the plaster to the base by using a laser is performed by using ultra short-light pulses, such as femtosecond light pulses or attosecond light pulses.

[0197] Embodiment 34: The method according to any one of Embodiments 25 to 33, wherein the body-wearable medical device is a body-wearable medical device according to any one of Embodiments 1 to 25.

[0198] Short description of the Figures

[0199] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0200] In the Figures:

[0201] Figure 1 shows an exemplary body -wearable medical device;

[0202] Figure 2 shows an exemplary method for securely joining a plaster to a base of a bodywearable medical device; and

[0203] Figure 3 shows a detail of the exemplary body -wearable medical device. P39271 -EP

[0204] Detailed description of the embodiments

[0205] Figures 1 shows an exemplary body-wearable medical device 110. The exemplary bodywearable medical device 110 comprises: a base 112, preferably configured for supporting at least one component of the body- wearable medical device 110, a plaster 114 comprising a first surface 116 and a second surface 118, wherein the first surface 116 is arranged opposite to the second surface 118, wherein the first surface 116 comprises an adhesive configured for adhering the plaster 114 to a user’s skin, wherein the second surface 118 of the plaster 114 is, at least in part, laser- welded to the base 112.

[0206] Particularly due to laser- welding, the adhesive of the first surface 116 may be free of defects having a reduced adhesive force, preferably wherein the adhesive of the first surface 116 is free of the defect having the reduced adhesive force that are caused by a process of securely joining the base 112 to the plaster 114.

[0207] Particularly due to laser- welding, in one or more joint areas 120, at which the second surface 118 of the plaster 114 and the base 112 are laser- welded together, the material of the second surface 118 of the plaster 114 and the material of the base 112 may be thermally welded.

[0208] The plaster 114 may comprise a plaster body 122 and one or more distinct absorption areas 124, wherein, preferably each of, the one or more distinct absorption areas 124 of the plaster 114 comprise at least one additive 126 having an absorption coefficient larger than the plaster body 122 for light 134 irradiated by a laser, which is used for laser-welding the second surface 118 of the plaster 114 to the base 112, preferably and wherein the one or more distinct absorption areas 124 of the plaster 114 abut against the base 112.

[0209] The adhesive of the first surface 116 may be free of defects having a reduced adhesive force in the one or more joint areas at which the second surface 118 of the plaster 114 and the base 112 are laser- welded together, preferably wherein the adhesive of the plaster 114 is free of the defect having the reduced adhesive force in the one or more joint areas at which the second surface 118 of the plaster 114 and the base 112 are laser- welded together that are caused by a process of securely joining the base 112 to the plaster 114.

[0210] A material of the plaster body 122 may be or may comprise at least one or both of:

[0211] - Polycarbonat (PC); and P39271 -EP

[0212] Polypropylen (PP).

[0213] An amount of the at least one additive 126 of the one or more distinct absorption areas 124 of the plaster 114 may be further selected in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is in accordance with a melting point of at least one of: the plaster 114, the base 112.

[0214] The at least one additive 126 of the one or more distinct absorption areas 124 of the plaster 114, may be selected from at least one of: a color pigment, such as red, green, blue; a filler material, such as glass fiber, particularly woven glass fiber; a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

[0215] The one or more distinct absorption areas 124 of the plaster 114 may be on the second surface 118 of the plaster 114.

[0216] The one or more distinct absorption areas 124 of the plaster 114 may be arranged in at least one pattern, particularly in a manner that the one or more distinct absorption areas 124 lie on a circle. The at least one pattern related to the one or more distinct absorption areas 130 of the plaster 114 may be surrounding the passage opening 154. The at least one pattern related to the one or more distinct absorption areas 130 of the base 112 may be surrounding the passage opening 154. Further patterns may be possible. For example, the at least one pattern can form a random pattern or a rectangle.

[0217] The base 112 may comprise a base body 128 and one or more distinct absorption areas 130, wherein, specifically each of, the one or more distinct absorption areas 130 of the base 112 comprise at least one additive 126 having an absorption coefficient larger than the base body 128 for the light 134 irradiated by the laser, which is used for laser-welding the second surface 118 of the plaster 114 to the base 112, particularly and wherein the one or more distinct absorption areas 130 of the base 112 abut against the second surface 118 of the plaster 114.

[0218] A material of the base body 128 may be or may comprise at least one or both of:

[0219] - Polycarbonat (PC); and

[0220] - Polypropylen (PP). P39271 -EP

[0221] An amount of the at least one additive 126 of the one or more distinct absorption areas 130 of the base 112 may be further selected in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature may be selected in accordance with a melting point of at least one of: the plaster 114, the base 112.

[0222] Thee at least one additive 126 of the one or more distinct absorption areas 130 of the base 112 may be selected from at least one of: a color pigment, such as red, green, blue; a filler material, such as glass fiber, particularly woven glass fiber; a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

[0223] The one or more distinct absorption areas 130 of the base 112 may be arranged in at least one pattern, particularly in a manner that the one or more distinct absorption areas 130 of the base 112 lie on a circle.

[0224] The plaster 114 may comprise a passage opening 154, preferably for an protruding element 156 comprised by the body -wearable medical device 110 that is protruding from the base 112 through the passage opening 154.

[0225] The protruding element 156 may be selected from at least one of: an analyte sensor assembly; a cannula, preferably a soft cannula or steel cannula, a tubing.

[0226] The base 112 may be at least partially transparent for the light 134 emitted by the laser, which is used for laser-welding the second surface 118 of the plaster 114 to the base 112.

[0227] The base 112 may comprise the base body 128 and at least one laser 132 window 136, wherein the at least one laser 132 window 136 may have a higher transmission coefficient than the base body 128 for the light 134 emitted by the laser, which is used for laser-welding the second surface 118 of the plaster 114 to the base 112.

[0228] The adhesive configured for adhering the body- wearable medical device 110 to the user’s skin may be a biocompatible adhesive. The adhesive configured for adhering the bodywearable medical device 110 to the user’s skin may be a heat-resistant adhesive.

[0229] The body -wearable medical device 110 is selected from at least one of: P39271 -EP a continuous analyte monitoring device, specifically a glucose monitoring device; a fluid delivery device, in particular an insulin infusion pump.

[0230] In Figure 2, an exemplary method 140 for securely joining a plaster 114 to a base 112 of a body- wearable medical device 110 is depicted, preferably wherein the base 112 is configured for supporting at least one component of the body- wearable medical device 110, wherein the plaster 114 comprises a first surface 116 and a second surface 118, wherein the first surface 116 is arranged opposite to the second surface 118, wherein the first surface 116 comprises an adhesive configured for adhering the to a user’s skin, the method comprising:

[0231] (denoted by reference number 142) laser- welding the second surface 118 of the plaster 114 to the base 112 by using a laser.

[0232] The plaster 114 may comprise a plaster body 122 and one or more distinct absorption areas, wherein, preferably each of, the one or more distinct absorption areas of the plaster 114 comprise at least one additive 126 having an absorption coefficient for light 134 irradiated by the laser 132 larger than the plaster body 122, preferably and wherein the one or more distinct absorption areas of the plaster 114 abut against the base 112, the method comprising: (denoted by reference number 144) selecting an amount of the at least one additive 126 of the distinct absorption areas of the plaster 114 in accordance with a target temperature to be achieved when performing the laser 132 welding, wherein the target temperature is in accordance with a melting point of at least one of: the plaster 114, the base 112.

[0233] The base 112 may comprise a base body 128 and one or more distinct absorption areas, wherein, specifically each of, the one or more distinct absorption areas of the base 112 comprise at least one additive 126 having an absorption coefficient for the light 134 irradiated by the laser 132 larger than the base body 128, particularly and wherein the one or more distinct absorption areas of the base 112 abut against the second surface 118 of the plaster 114, the method comprising:

[0234] (denoted by reference number 146) selecting an amount of the at least one additive 126 of the distinct absorption areas of the base 112 in accordance with a target temperature to be achieved when performing the laser-welding, wherein the target temperature is selected in accordance with a melting point of at least one of: the plaster 114, the base 112. P39271 -EP

[0235] Laser-welding the second surface 118 of the plaster 114 to the base 112 by using a laser 132 may comprise

[0236] (denoted by reference number 148) pressing the plaster 114 and the base 112 against each other while the plaster 114 and the base 112 are joined by laser-welding, particularly by using at least one of: a clamp; a fixture; a press.

[0237] Laser-welding the second surface 118 of the plaster 114 to the base 112 by using a laser 132 may comprise

[0238] (denoted by reference number 150) irradiating, particularly exclusively, at least one of: the one or more distinct absorption areas on the plaster 114; the one or more distinct absorption areas on the base 112 by using the laser 132 in a manner that the plaster 114 and the base 112 are joined by laser- welding.

[0239] As may be derived from Ligure 3, laser-welding the second surface 118 of the plaster 114 to the base 112 by using a laser 132 may be performed in a manner that the light 134 emitted by the laser 132 traverses through the base 112 before impinging on the second surface 118 of the plaster 114. In Ligure 3 the distinct absorption area 130 is exemplarily comprised by the base 114.

[0240] The base 112 comprises at least one laser 132 window 136, wherein the at least one laser 132 window 136 has a higher transmission coefficient than the base body 128 for the light 134 emitted by the laser, wherein laser-welding the second surface 118 of the plaster 114 to the base 112 by using a laser 132 is performed in a manner that the light 134 emitted by the laser 132 traverses through the at least one laser 132 window 136.

[0241] Laser-welding the second surface 118 of the plaster 114 to the base 112 by using a laser 132 may comprise

[0242] (denoted by reference number 152) cooling at least one of: the plaster 114; the base 112, while the plaster 114 and the base 112 are joined by laser-welding, particularly by using at least one of: a cooling device, a cooling as part of a clamping and / or fixture, a contact cooling, an air cooling.

[0243] Laser-welding the second surface 118 of the plaster 114 to the base 112 by using a laser 132 may be performed by using ultra short-light 134 pulses, such as femtosecond light 134 pulses or attosecond light 134 pulses. P39271 -EP

[0244] The body- wearable medical device 110 may be a body-wearable medical device 110 as elsewhere disclosed herein.

[0245] List of reference numbers

[0246] 110 exemplary body-wearable medical device

[0247] 112 base

[0248] 114 plaster

[0249] 116 first surface of the plaster

[0250] 118 second surface of the plaster

[0251] 120 joint area

[0252] 122 plaster body

[0253] 124 distinct absorption areas of the plaster

[0254] 126 additive

[0255] 128 base body

[0256] 130 distinct absorption areas of the base

[0257] 132 laser

[0258] 134 laser light

[0259] 136 laser window

[0260] 138 additive

[0261] 140 exemplary method for securely joining a plaster to a base of a body- wearable medical device

[0262] 142 laser-welding the second surface of the plaster to the base

[0263] 144 selecting an amount of the at least one additive of the distinct absorption areas of the plaster

[0264] 146 selecting an amount of the at least one additive of the distinct absorption areas of the base

[0265] 148 pressing the plaster and the base against each other

[0266] 150 irradiating the one or more distinct absorption areas

[0267] 152 cooling the plaster and / or the base

[0268] 154 passage opening

[0269] 156 protruding element

Claims

1. P39271 -EPRoche Diabetes Care GmbH September 26, 2024RD39271EP ST7PHClaims1. A body-wearable medical device (110) comprising: a base (112), a plaster (114) comprising a first surface (116) and a second surface (118), wherein the first surface (116) is arranged opposite to the second surface (118), wherein the first surface (116) comprises an adhesive configured for adhering the plaster (114) to a user’s skin, wherein the second surface (118) of the plaster (114) is, at least in part, laser-welded to the base (112).

2. The body- wearable medical device (110) according to the claim 1, wherein the adhesive of the first surface (116) is free of the defect having the reduced adhesive force that are caused by a process of securely joining the base (112) to the plaster (114).

3. The body- wearable medical device (110) according to any one of claim 1 or 2, wherein in one or more joint areas at which the second surface (118) of the plaster (114) and the base (112) are laser-welded together, the material of the second surface (118) of the plaster (114) and the material of the base (112) are thermally welded.

4. The body- wearable medical device (110) of any one of claims 1 to 3, wherein the plaster (114) comprises a plaster body (122) and one or more distinct absorption areas (124), wherein the one or more distinct absorption areas (124) of the plaster (114) comprise at least one additive (126) having an absorption coefficient larger than the plaster body (122) for light (134) irradiated by a laser, which is used for laser-welding the second surface (118) of the plaster (114) to the base (112).

5. The body-wearable medical device (110) according to any one of the claims 3 or 4, wherein the at least one additive (126) of the one or more distinct absorption areas of the plaster (114), is selected from at least one of: a color pigment, such as red, green, blue; a filler material, such as glass fiber, particularly woven glass fiber;36P39271 -EP a material having a semi-crystalline structure, such as a thermoplastic polymer (PBT).

6. The body- wearable medical device (110) according to the any one of claims 1 to 5, wherein the base (112) comprises a base body (128) and one or more distinct absorption areas, wherein, the one or more distinct absorption areas of the base (112) comprise at least one additive (126) having an absorption coefficient larger than the base body (128) for the light (134) irradiated by the laser, which is used for laserwelding the second surface (118) of the plaster (114) to the base (112).

7. The body- wearable medical device (110) according to the any one of claims 1 to 6, wherein the plaster (114) comprises a passage opening (154) for an protruding element (156) comprised by the body-wearable medical device (110) that is protruding from the base (112) through the passage opening (154).

8. The body- wearable medical device (110) according to the any one of claims 1 to 7, wherein the protruding element (156) is selected from at least one of:- an analyte sensor assembly;- a cannula,- a tubing.

9. The body-wearable medical device (110) according to the any one of claims 1 to 8, wherein the base (112) comprises the base body (128) and at least one laser window (136), wherein the at least one laser window (136) has a higher transmission coefficient than the base body (128) for the light (134) emitted by the laser, which is used for laser- welding the second surface (118) of the plaster (114) to the base (112).

10. The body-wearable medical device (110) according to the any one of claims 1 to 9, wherein the body-wearable medical device (110) is selected from at least one of: a continuous analyte monitoring device, specifically a glucose monitoring device; a fluid delivery device, in particular an insulin infusion pump.

11. A method for securely joining a plaster (114) to a base (112) of a body-wearable medical device (110), wherein the plaster (114) comprises a first surface (116) and a second surface (118), wherein the first surface (116) is arranged opposite to the second37P39271 -EP surface (118), wherein the first surface (116) comprises an adhesive configured for adhering the to a user’s skin, the method comprising: laser- welding the second surface (118) of the plaster (114) to the base (112) by using a laser.

12. The method according to claim 11, wherein laser-welding the second surface (118) of the plaster (114) to the base (112) by using a laser (132) comprises pressing the plaster (114) and the base (112) against each other while the plaster (114) and the base (112) are joined by laser-welding, particularly by using at least one of: a clamp; a fixture; a press.

13. The method according to any one of claims 11 or 12, wherein laser- welding the second surface (118) of the plaster (114) to the base (112) by using a laser (132) comprises irradiating, particularly exclusively, at least one of: the one or more distinct absorption areas on the plaster (114); the one or more distinct absorption areas on the base (112) by using the laser (132) in a manner that the plaster (114) and the base (112) are joined by laser-welding.

14. The method according to any one of claims 11 to 13 , wherein laser- welding the second surface (118) of the plaster (114) to the base (112) by using a laser (132) comprises cooling at least one of: the plaster (114); the base (112), while the plaster (114) and the base (112) are joined by laser-welding.

15. The method according to any one of claims 11 to 14, wherein laser- welding the second surface (118) of the plaster (114) to the base (112) by using a laser (132) is performed in a manner that the light (134) emitted by the laser (132) traverses through the base (112) before impinging on the second surface (118) of the plaster (114).

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