Body-worn medical devices containing superabsorbent materials

Abstract

The present invention relates to a body-wearable medical device comprising a medical device housing including a transcutaneous element configured to be at least partially inserted into a patient's body at an insertion site during use of the body-wearable medical device, and a base configured to removably attach the body-wearable medical device to the patient's skin during use, the base comprising a first surface that faces the patient's body during use of the body-wearable medical device and that includes an adhesive for adhering the body-wearable medical device to the patient's skin. To reduce the possibility of contamination by bodily fluids leaking from an injury during insertion, the base further comprises a superabsorbent material and at least one fluid channel on the first surface, the at least one fluid channel configured to direct bodily fluids from the insertion site to the superabsorbent material.

Description

[Technical field]

[0001] The present invention relates to a body wearable medical device comprising: a medical device housing including a transcutaneous element configured to be at least partially inserted into a patient's body at an insertion site during use of the body wearable medical device; and a base portion configured to removably attach the body wearable medical device to the patient's skin during use, the base portion having a first surface that faces the patient's body during use of the body wearable medical device and that includes an adhesive for adhering the body wearable medical device to the patient's skin. [Background technology]

[0002] During use, the conventionally known body-worn medical device is releasably attached to the patient's skin at an insertion site by an adhesive, and the transcutaneous element is inserted at least partially into the patient's body. During the insertion of the transcutaneous element at least partially into the patient's body or during use of the body-worn medical device, bodily fluids, such as blood, wound exudate or interstitial fluid, may flow out from an insertion injury caused by the transcutaneous element. The flow of bodily fluids may not only soil the patient's clothing, but also the body-worn medical device itself. If the body fluids soil the body-worn medical device, especially if they cover the sensor element or electronics, or if they enter the body-worn medical device, they may cause malfunction of the body-worn medical device and may also pose a hygiene risk. Furthermore, the body fluids flowing out from an insertion injury may reduce the adhesive of the first surface of the base part of the body-worn medical device. Thus, there is an opportunity for the body-worn medical device to be unintentionally detached from the patient's body. Summary of the Invention [Problem to be solved by the invention]

[0003] It is therefore an object of the present invention to provide a body-wearable medical device which avoids at least one of the problems associated with medical devices known from the prior art, in particular to provide a body-wearable medical device which is less prone to malfunctions caused by contamination with body fluids escaping from damage during insertion and / or which is less prone to unintentional detachment from the patient's body.

[0004] At least one of the above objectives is achieved by providing subject matter disclosed in the claims and throughout the specification. [Means for solving the problem]

[0005] According to a first aspect, a body-wearable medical device is provided. The body-wearable medical device includes a medical device housing including a transcutaneous element configured to be at least partially inserted into a patient's body at an insertion site during use of the body-wearable medical device, and a base portion configured to removably attach the body-wearable medical device to the patient's skin during use. The base portion includes a first surface that faces the patient's body during use of the body-wearable medical device and includes an adhesive for adhering the body-wearable medical device to the patient's skin. The base portion further includes a superabsorbent material and at least one fluid channel on its first surface, the at least one fluid channel configured to direct bodily fluid from the insertion site to the superabsorbent material.

[0006] The first surface of the base faces the patient's body when removably attached to the patient's skin by the adhesive on the first surface of the base. A non-exhaustive list of example adhesives includes, but is not limited to, acrylic, dextrin, urethane, rubber, polyvinyl ether adhesives, and other adhesives based on natural and synthetic elastomers.

[0007] The second side of the base portion is disposed opposite the first side, i.e., forms the side of the base portion that faces away from the patient's skin during use of the body-wearable medical device. The second side is attached to the medical device housing such that the medical device housing is removably attached to the patient's skin via the base portion during use of the body-wearable medical device. For example, the medical device housing is attached to the second side by adhesive or ultrasonic welding.

[0008] By being included in the first surface of the base portion, the superabsorbent material and at least one fluid channel are therefore also oriented towards the patient's body so that bodily fluids that may escape from the insertion damage caused by the percutaneous element are directed to the superabsorbent material by the at least one fluid channel. By directing bodily fluids from the insertion site to the superabsorbent material, the fluid channel helps to promote the superabsorbent material to absorb the bodily fluids and prevents the bodily fluids from bypassing the superabsorbent material. According to an embodiment, the fluid channel is formed by silicone, directionally aligned fibers, directionally aligned capillaries, cellulose, or foam, or a combination of the above. Without being bound to a particular theory, in an embodiment of the present invention, capillary forces direct the bodily fluids from the insertion site to the superabsorbent material. By way of example, the at least one fluid channel may be formed by a silicone structure configured to direct the bodily fluids from the insertion site to the superabsorbent material. The silicone structure can at least partially protrude from and / or be at least partially integrated into the first surface of the base such that the silicone structure contacts the user's skin and the base during use of the body-worn medical device. The silicone structure, together with the base and the skin, forms a tunnel-shaped flow path that directs the flow of bodily fluids from the insertion site to the superabsorbent material.

[0009] After being guided to the superabsorbent material, the body fluid is at least partially absorbed by the superabsorbent material. The superabsorbent material is thus configured to absorb the body fluid that flows out from the insertion damage caused by the percutaneous element. This is associated with the advantage that the body fluid absorbed by the superabsorbent material is retained therein and therefore can no longer soil the body-worn medical device and / or the patient's clothing. Furthermore, the absorbed and retained body fluid does not adversely affect the adhesion of the adhesive, thus preventing the body-worn medical device from being unintentionally removed from the patient's body.

[0010] In the sense of the present invention, a superabsorbent material is capable of absorbing and retaining large amounts of water in an aqueous solution. Superabsorbents in the sense of the present invention are, for example, modified starch, polymerized polyvinyl alcohol (PVA) and polyethylene oxide (PEO), which are hydrophilic and have a high affinity for water. These superabsorbents become water-swellable but not water-soluble when crosslinked chemically or physically. In an embodiment, the superabsorbent material is a superabsorbent polymer in the form of granular particles, fibers, or mixtures thereof. In a further variant, the superabsorbent polymer is made by polymerization of acrylic acid blended with sodium hydroxide in the presence of initiated polyacrylic acid sodium salt. Alternatively, the superabsorbent polymer can be ethylene maleic anhydride copolymer, crosslinked carboxymethylcellulose, polyvinyl alcohol copolymer, crosslinked polyethylene oxide, and dendritic graft copolymer of polyacrylonitrile. The superabsorbent polymer can be made by standard methods such as gel polymerization, suspension polymerization, or solution polymerization.

[0011] According to an embodiment of the present invention, the body-worn medical device is one of a drug delivery device, such as an insulin pump, or a medical device configured to analyze a patient's bodily fluids, in particular a medical device for measuring an analyte, such as a continuous glucose monitoring device.

[0012] In an embodiment of the invention, the transcutaneous element is a cannula, e.g. a soft or steel cannula, a probe configured to collect bodily fluids, or a sensor configured to analyze bodily fluids. The presence of a transcutaneous element does not exclude the presence of additional elements. For example, if the transcutaneous element is a cannula of a drug delivery device or an insulin pump, respectively, the drug delivery device or the insulin pump may further include additional transcutaneous elements, e.g. a probe or sensor of the type outlined above. Similarly, in the case of a continuous glucose monitoring device, the transcutaneous element is a probe or sensor of the type outlined above, and the continuous glucose monitoring device may further include an additional probe or sensor or cannula of the type outlined above.

[0013] According to an embodiment, the body-worn medical device is a drug delivery device or an insulin pump and the transcutaneous element is a cannula, for example a soft cannula or a steel cannula. In another embodiment, the body-worn medical device is a continuous glucose monitoring device and the transcutaneous element is a probe or sensor of the type outlined above, i.e. a probe configured to collect bodily fluids or a sensor configured to analyze bodily fluids.

[0014] Apart from including the adhesive, in an embodiment, the base further includes a pad that is adhered to the patient's body by the adhesive during use of the body-worn medical device. To improve handling of the body-worn medical device and to prevent the adhesive from unintentionally coming off, the adhesive can be covered by one or more backing layers that must be peeled off from the adhesive before use of the body-worn medical device. The pad can include one or more of a sterile nonwoven fabric, cellulose, tissue or paper.

[0015] Additionally or alternatively, in an embodiment, the base portion is vapor permeable and / or includes a vapor permeable membrane configured to allow vapor to flow through the base portion and / or the vapor permeable membrane. Moisture that may tend to accumulate in or under the base portion during use of the body-worn medical device can at least partially evaporate through the base portion and / or the vapor permeable membrane. Evaporation of vapor through the base portion and / or the vapor permeable membrane contributes to providing a wound healing environment and / or a skin-friendly environment around the insertion site and under the body-worn medical device. Furthermore, evaporation of moisture helps to reduce the accumulation of moisture under the body-worn medical device, and thus helps to prevent the body-worn medical device from being unintentionally removed.

[0016] In an embodiment, the superabsorbent material at least partially surrounds the transcutaneous element. At least partially surrounds in the sense of the present invention means that the superabsorbent material comprises segments arranged on the first side of the base part at at least two different angular positions relative to the transcutaneous element. The superabsorbent material may form a continuous or discontinuous structure. A continuous structure in the sense of the present invention is a structure that surrounds the transcutaneous element without having any gaps therein that allow the body fluids flowing out of the insertion site along the first side of the base part to pass through the superabsorbent structure without wetting the superabsorbent material.

[0017] In an embodiment, the superabsorbent material forms an enclosure on the first surface of the base, the superabsorbent material surrounding the transdermal element. The enclosure surrounding the transdermal element is a continuous structure surrounding the transdermal element. The superabsorbent material is configured to absorb and retain bodily fluids and may form a barrier that prevents bodily fluids from flowing beyond the area surrounded by the superabsorbent material. According to an embodiment, the enclosure forms a ring that surrounds the transdermal element.

[0018] According to an embodiment of the body-worn medical device, the superabsorbent material on the first surface of the base portion forms a discontinuous enclosure by having a plurality of enclosure segments displaced from one another along a first imaginary enclosure around the medical device housing. The enclosure is discontinuously formed on the first surface of the base portion by a plurality of enclosure segments displaced from one another along the first imaginary enclosure. The first imaginary enclosure surrounds the transdermal element along a geometric shape. A non-exhaustive group of geometric shapes includes, by way of example, rings, ellipses, rectangles, and polygons. By displacing from one another along the first imaginary enclosure, there are gaps between adjacent enclosure segments. The spacing between adjacent enclosure segments contributes to allowing the structure formed by the superabsorbent material to more flexibly adapt to the body shape of the insertion site. In an embodiment, the plurality of enclosure segments are ring segments displaced from one another along the first imaginary ring. In an embodiment, each segment is connected to at least one of the at least one fluid channel, and in another embodiment, each segment is connected to 1 to 4 fluid channels, or 1 to 3 fluid channels, or 1 to 2 fluid channels, or 1 fluid channel.

[0019] In an embodiment, the superabsorbent material on the first side of the base portion forms a continuous or discontinuous inner enclosure and a continuous or discontinuous outer enclosure. Both the inner and outer enclosures form a barrier for absorbing and retaining bodily fluids that escape from an insertion injury during use of the body-worn medical device. Since the inner and outer enclosures at least partially surround the transcutaneous element, the terms "inner" and "outer" refer to the radial distance of the inner and outer enclosures, respectively, from the transcutaneous element along the first side of the barrier. According to an embodiment, the inner enclosure is formed continuously along a first imaginary enclosure, and the outer enclosure is formed discontinuously along a second imaginary enclosure. In an embodiment, the distance between the insertion site and the furthest part of the inner enclosure is less than the distance between the insertion side and the nearest part of the outer enclosure. In an embodiment, the inner and outer enclosures are arranged concentrically with the transcutaneous element in the center. The inner and outer enclosures can form two concentric rings. In one embodiment, the inner enclosure is discontinuously formed along the first imaginary enclosure, and the outer enclosure is continuous along the second imaginary enclosure. In yet another embodiment, the inner enclosure is continuous along the first imaginary enclosure, and the outer enclosure is continuous along the second imaginary enclosure. In another embodiment, the inner enclosure is discontinuously formed along the first imaginary enclosure, and the outer enclosure is continuous along the second imaginary enclosure.

[0020] In an embodiment, the superabsorbent material on the first surface of the base portion forms a discontinuous inner enclosure having a plurality of inner enclosure segments and a discontinuous outer enclosure having a plurality of outer enclosure segments, the plurality of inner enclosure segments and the plurality of outer enclosure segments being arranged in alternating angular positions relative to the transcutaneous element along a first imaginary enclosure and along a second imaginary enclosure. Together, the inner enclosure and the outer enclosure form a barrier for absorbing and retaining bodily fluids resulting from an insertion injury caused by the transcutaneous element. The plurality of inner enclosure segments and the plurality of outer enclosure segments are arranged on the first surface of the base portion along a first imaginary enclosure and a second imaginary enclosure, respectively, the inner enclosure segments and the outer enclosure segments being arranged in alternating angular positions relative to the transcutaneous element. In an embodiment, the inner enclosure segments and the outer enclosure segments are formed by ring segments.

[0021] According to an embodiment, the base portion further includes a septum configured to be punctured by a percutaneous element during use of the body-worn medical device. During use of the body-worn medical device, the septum of the base portion is traversed by the percutaneous element. According to an embodiment, the septum is a self-sealing septum, i.e., when a percutaneous element (e.g., a cannula, a sensor, etc.) is inserted through the septum and then removed, the septum closes and forms a microbial and bodily fluid barrier. The self-sealing septum may be made of, for example, silicone, plastic, polyurethane foam, or a combination thereof.

[0022] In an embodiment, the first face of the base part further comprises an outer sealing element surrounding the superabsorbent material on the side of the superabsorbent material facing away from the transcutaneous element. The outer sealing element serves to keep body fluids inside the area surrounded by the outer sealing element. The outer sealing element forms a barrier in addition to the superabsorbent material forming a first barrier for body fluids. In contrast to the superabsorbent material, the outer sealing element in the sense of the present invention does not significantly absorb body fluids compared to the superabsorbent material. In an embodiment, the outer sealing element is formed by a hydrophobic material. The sealing element is arranged on the outside of the superabsorbent material, i.e. on the side of the superabsorbent material facing away from the transcutaneous element, thereby forming an outer boundary when viewed from the perspective of the transcutaneous element.

[0023] According to an embodiment, the first surface of the base part further comprises an inner seal element on the side of the superabsorbent material facing the transcutaneous element. The seal element forms an inner barrier that helps to retain bodily fluids inside the area enclosed by the inner seal element. The inner seal element is arranged on the side of the superabsorbent material facing the transcutaneous element and forms an inner barrier. The inner seal element surrounds the area of ​​the first surface of the base part that houses the transcutaneous element. The superabsorbent material is arranged outside the area enclosed by the seal arranged on the side of the superabsorbent material facing the transcutaneous element.

[0024] In an embodiment, the inner seal element and / or the outer seal element, if present, are formed by or include a silicone structure that protrudes at least partially from the discontinuous first side of the discontinuous base portion and / or is integrated into the discontinuous first side of the discontinuous base portion, such that the discontinuous silicone structure contacts the discontinuous base portion and the discontinuous skin of the discontinuous user during use of the discontinuous body-worn medical device. By way of example, the inner seal element and / or the outer seal element can be made of or include a lip or structure that protrudes at least partially from the first side of the base portion toward or in contact with the skin of the user during use of the body-worn medical device. The lip or structure can be, by way of example, a silicone lip or silicone structure that forms a physical barrier that prevents bodily fluids from passing through the barrier.

[0025] In an embodiment, the first surface of the base portion includes a plaster carrying an adhesive for attaching the body wearable medical device to the patient's body. The plaster can help adhere the body wearable medical device to the body shape at the insertion surface.

[0026] Further advantages, features and technical effects of the present invention will be apparent from the following description of the embodiments and the accompanying drawings. [Brief description of the drawings]

[0027] [Figure 1] 1 shows a cross section of a body wearable medical device according to an embodiment of the present invention. [Diagram 2] 2 shows a top view of the body wearable medical device according to the embodiment of FIG. 1. [Diagram 3] FIG. 1 shows a top view of a body wearable medical device according to an embodiment of the present invention. [Figure 4] 1 shows a cross section of a body wearable medical device according to an embodiment of the present invention. [Diagram 5] 1 shows a cross section of a body wearable medical device according to an embodiment of the present invention. [Figure 6]1 shows a cross-section of a body wearable medical device according to yet another embodiment of the present invention. [Figure 7] 1 shows a top view of a body wearable medical device according to a further embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] 1 and 2 show an embodiment according to a first embodiment of the present invention, where FIG. 1 shows a cross section of a body-wearable medical device 1 and FIG. 2 shows a top view of the body-wearable medical device 1. The body-wearable medical device 1 comprises a medical device housing 18 and a transcutaneous element 2. The transcutaneous element 2 is configured to be at least partially inserted into the skin of a patient's body 3 at an insertion site 4 during use of the body-wearable medical device 1. Here, the transcutaneous element 2 is, by way of example, a cannula. Alternatively, the transcutaneous element 2 can be a probe configured to collect a body fluid or a sensor configured to analyze the body fluid.

[0029] In FIG. 1, a patient's body 3 and an insertion site 4 are shown to illustrate the intended use of a body-worn medical device 1 by way of example.

[0030] The body wearable medical device 1 further comprises a base portion 5. The base portion 5 has a first surface 6a that faces towards the patient's body 3 during use of the body wearable medical device 1. The first surface 6a of the base portion 5 further comprises an adhesive 7 for adhering the body wearable medical device 1 to the patient's skin during use. The base portion 5 further comprises a second surface 6b opposite the first surface 6a and facing away from the patient's body during use. The second surface 6b is coupled to the medical device housing 18.

[0031] When the transcutaneous element 2 is at least partially inserted into the patient's body 3, it forms an opening in the patient's skin. Body fluids escaping from this opening may soil or adversely affect the functionality of the body-wearable medical device 1 or may soil the patient's clothing. However, to absorb and retain body fluids that may escape from the opening caused by the transcutaneous element 2 during use of the body-wearable medical device 1, a superabsorbent material 8 and fluid channels 9 are provided on the first surface 6a of the base portion 5 of the body-wearable medical device 1. The fluid channels 9 direct body fluids from the insertion site 4 to the superabsorbent material 8.

[0032] 2, the superabsorbent material exemplarily forms a continuous structure surrounding the transcutaneous element 2 of the body wearable medical device 1. The adhesive 7 for adhering the body wearable medical device 1 to the patient's skin is carried by a plaster 17 provided on the first side 6a of the body wearable medical device 1. In the top view, the plaster 17 extends beyond the protruding portion of the base portion 5 of the body wearable medical device 1.

[0033] Figure 3 shows a top view of a body-worn medical device 1 according to a further embodiment of the invention. The embodiment of Figure 3 differs from the embodiment of the body-worn medical device 1 as shown in Figures 1 and 2 by further comprising a fluid channel 9. The fluid channel 9 is configured to direct body fluid from the insertion site 4 to the superabsorbent material 8. Here, the fluid channel 9 comprises four arms forming a cross and directing body fluid from the insertion site 4 of the transcutaneous element 2 to the superabsorbent material 8.

[0034] Figure 4 shows a cross-section of a body wearable medical device 1, which differs from the embodiment according to figures 1 and 2 in that it has a different shape of superabsorbent material 8. Here, the superabsorbent material 8 forms a continuous inner and outer surround, which together surround the transcutaneous element 2 along the first face 6a of the base part 5. The continuous inner and outer surrounds form two concentric circles, the common centre of the two circles being formed by the transcutaneous element 2.

[0035] 5 shows a cross-section of a further embodiment of a body-worn medical device 1 according to the invention. The body-worn medical device 1 according to the embodiment of FIG. 5 differs from the embodiment according to FIG. 1 by having an outer sealing element 16. The outer sealing element 16 surrounds the superabsorbent material 8 on the side of the superabsorbent material 8 facing outwardly of the transcutaneous element 2. The superabsorbent material 8 as well as the transcutaneous element 2 are thus surrounded by the outer sealing element 16 and are thus arranged inside the area of ​​the first face 6a of the base part 5 surrounded by the outer sealing element 16.

[0036] Figure 6 shows a cross section of yet another embodiment of a body-worn medical device 1 according to the invention. The body-worn medical device 1 of Figure 6 differs from the body-worn medical device 1 of Figure 5 by further having an inner sealing element 15. The inner sealing element 15 surrounds the transcutaneous element 2 with the side of the superabsorbent material 8 facing the transcutaneous element 2 and is therefore arranged at a shorter radial distance from the transcutaneous element 2 than the superabsorbent material 8. The first side 1 of the base part 5 of the body-worn medical device 1 according to Figure 6 further additionally comprises a partition 14. The partition 14 is configured to be punctured by the transcutaneous element 2 during use of the body-worn medical device 1.

[0037] 7 shows a top view of a body-worn medical device 1 according to a further embodiment of the invention. The body-worn medical device 1 of FIG. 7 differs from the body-worn medical device 1 according to FIG. 1 by having a superabsorbent material 8 forming a discontinuous inner enclosure and a discontinuous outer enclosure. The discontinuous inner enclosure is formed by a plurality of inner enclosure segments 10, and the discontinuous outer enclosure 12 is formed by a plurality of outer enclosure segments 11. The plurality of inner enclosure segments 10 are arranged on the first face 6a of the base part 5 along a first imaginary enclosure 12, and the plurality of outer enclosure segments 11 are arranged on the first face 6a of the base part 5 along a second imaginary enclosure 13. The inner enclosure segments 10 and the outer enclosure segments 11 are alternately arranged at different angular positions relative to the transcutaneous element 2. Each inner surround segment 10 and each outer surround segment 11 is connected to a fluid channel 9, and each fluid channel 9 is configured to direct bodily fluids exiting the insertion site to the superabsorbent material 8 of the respective segment 10, 11. [Explanation of symbols]

[0038] 1. Body-worn medical devices 2. Transcutaneous elements 3. Patient's body 4 Insertion site 5 Base 6a First surface of the base 6b Second surface of the base 7. Glue 8. Superabsorbent Materials 9 Fluid Channels 10 Inner Enclosure Segment 11 Outer Enclosure Segment 12 First virtual enclosure 13 Second Virtual Enclosure 14 Bulkhead 15 Inner sealing element 16 Outer sealing element 17 Plaster 18 Medical Equipment Housing

Claims

1. A body-wearable medical device (1), comprising: a medical device housing (18) including a percutaneous element (2) configured to be at least partially inserted into a patient's body (3) at an insertion site (4) during use of the body-worn medical device (1); a base portion (5) configured to removably attach the body-worn medical device housing (18) to the skin of a patient during use; the base portion (5) comprises a first surface (6a) facing the patient's body (3) during use of the body wearable medical device (1) and comprising an adhesive (7) for adhering the body wearable medical device housing (18) to the patient's skin; The body-wearable medical device, characterized in that the base portion (5) further comprises a superabsorbent material (8) and at least one fluid channel (9) on a first surface (6a), the at least one fluid channel (9) being configured to direct bodily fluid from the insertion site (4) to the superabsorbent material (8).

2. 2. The body-worn medical device (1) according to claim 1, characterized in that the superabsorbent material (8) at least partially surrounds the transdermal element (2).

3. 3. The body-worn medical device (1) according to claim 1 or 2, characterized in that the superabsorbent material (8) forms a surrounding portion on the first surface (6a) of the base portion (5), the superabsorbent material (8) surrounding the transdermal element (2).

4. 4. The body-wearable medical device (1) according to any one of claims 1 to 3, characterized in that the superabsorbent material (8) of the first surface (6a) of the base portion (5) has a plurality of enclosure segments (10) which are displaced from one another along a first imaginary enclosure (12), thereby forming a discontinuous enclosure.

5. 5. The body-wearable medical device (1) according to any one of claims 1 to 4, characterized in that the superabsorbent material (8) of the first surface (6a) of the base portion (5) forms a continuous or discontinuous inner surround and a continuous or discontinuous outer surround.

6. 6. The body-worn medical device (1) according to claim 1, characterized in that the superabsorbent material (8) of the first surface (6a) of the base portion (5) forms a discontinuous inner enclosure having a plurality of inner enclosure segments (10) and a discontinuous outer enclosure having a plurality of outer enclosure segments (11), the plurality of inner enclosure segments (10) and the plurality of outer enclosure segments (11) being arranged alternately with respect to their angular position relative to the transcutaneous element (2) along a first imaginary enclosure (12) and along a second imaginary enclosure (13).

7. The body-wearable medical device (1) according to any one of claims 1 to 6, characterized in that the base portion (5) further comprises a partition (13) configured to be punctured by the percutaneous element (2) during use of the body-wearable medical device (1).

8. 8. The body-worn medical device (1) according to any one of claims 1 to 7, characterized in that the first surface (6a) of the base portion (5) further comprises an outer sealing element (14) surrounding the superabsorbent material (8) on the surface of the superabsorbent material (8) facing away from the transcutaneous element (2).

9. 9. The body wearable medical device (1) of claim 8, characterized in that the outer sealing element (14) is formed by or comprises a silicone structure protruding at least partially from and / or integrated into the first surface (6a) of the base part (5), whereby during use of the body wearable medical device (1), the silicone structure comes into contact with the base part (5) and the skin of the user.

10. The body-worn medical device (1) according to any one of claims 1 to 9, characterized in that the first surface (6a) of the base portion (5) further comprises an inner sealing element (15) on the side of the superabsorbent material (8) facing the transdermal element (2).

11. The body wearable medical device (1) of claim 10, characterized in that the inner sealing element (15) is formed by or comprises a silicone structure protruding at least partially from and / or integrated into the first surface (6a) of the base part (5), whereby during use of the body wearable medical device (1), the silicone structure comes into contact with the base part (5) and the skin of the user.

12. A body-wearable medical device (1) according to any one of claims 1 to 11, characterized in that the first surface (6a) of the base portion (5) is provided with a plaster (17) carrying the adhesive (7) for attaching the body-wearable medical device (1) to a patient's body (3).

13. 13. The body-wearable medical device (1) according to any one of claims 1 to 12, characterized in that each of the inner enclosure segment (10) and the outer enclosure segment (11) is connected to at least one of the at least one fluid channel (9).

Images