BODY WEARABLE MEDICAL DEVICE WITH SEALING ELEMENT - Patent application

Abstract

The present invention relates to a body wearable medical device comprising a first housing portion and a second housing portion, the first housing portion having a female portion and the second housing portion having a male portion, the male portion being at least partially inserted into the female portion thereby defining a circumferential gap, and a circumferential sealing element being disposed in the circumferential gap between the female and male portions. To provide a body wearable medical device with improved sealing that is less susceptible to failure due to stresses and forces exerted on the body wearable medical device, the female and male portions are secured to one another by a circumferential securing adhesive disposed in the circumferential gap between the female and male portions adjacent the circumferential sealing element.

Description

[Technical field]

[0001] The present invention relates to a body wearable medical device comprising a first housing portion and a second housing portion, the first housing portion having a female portion and the second housing portion having a male portion, the male portion being at least partially inserted into the female portion thereby defining a circumferential gap, and a circumferential sealing element being disposed in the circumferential gap between the female portion and the male portion. [Background technology]

[0002] A body wearable medical device is a small, relatively lightweight device that is carried by a patient during its use. Thus, the body wearable medical device is exposed to the same various environmental conditions and stresses as the patient. The body wearable medical device may or may not be concealed by clothing. To prevent malfunction caused by the ingress of dust, water, and / or moisture, a circumferential seal is provided within the circumferential gap between the female and male parts.

[0003] However, when the body-wearable medical device is carried by a user, it may be exposed to dust, water and humidity, as well as forces and stresses caused by the patient's movements and activities. For example, during sports or user movements, forces and stresses are exerted on the body-wearable medical device that may cause temporary deformation of the first housing part and / or the second housing part. The temporary deformation of the first housing part and / or the second housing part may change the width of the circumferential gap between the female part and the male part. The change in the width of the gap may adversely affect the sealing between the female part and the male part as provided by the sealing element. Summary of the Invention [Problem to be solved by the invention]

[0004] It is therefore an object of the present invention to provide a body wearable medical device with improved sealing that is less likely to be damaged by the stresses and forces exerted on the body wearable medical device. [Means for solving the problem]

[0005] At least one of the above objectives is solved by a body wearable medical device as outlined above, wherein the female and male parts are secured to one another by a circumferential securing adhesive disposed in a circumferential gap between the female and male parts, next to the circumferential sealing element.

[0006] The circumferential fixation adhesive serves to hold the position of the first housing part relative to the second housing part. The circumferential fixation adhesive at least partially fills the gap between the female part and the male part. Furthermore, the circumferential fixation adhesive serves to prevent a portion of the female part and a portion of the male part from being displaced relative to each other due to stresses or forces exerted on the body wearable medical device. This makes the gap less susceptible to deformation and the sealing element maintains its sealing function.

[0007] According to an embodiment, the sealing element is a sealing adhesive having a smaller elastic modulus than the fixing adhesive. The purpose of the fixing adhesive is to hold the female part and the male part in their relative positions, and the sealing adhesive prevents the ingress of at least one of water, dust, splash water and moisture. When providing the sealing element formed by the sealing adhesive, the sealing adhesive itself helps to hold the female part and the male part in their relative positions. Furthermore, the flexibility of the sealing adhesive helps to balance some deformation of the gap that may be caused by stress and / or force acting on the body-wearable medical device.

[0008] In an embodiment, the sealing adhesive is a polyurethane adhesive. In an embodiment, the polyurethane adhesive has a hardness of shore A40 or more and shore A50 or less. For example, the polyurethane adhesive has a hardness of shore A42. According to an embodiment, the polyurethane adhesive has a viscosity of 30.000 millipascal seconds or more, preferably 40.000 mPas or more, but 90.000 mPas or less, preferably 80.000 mPas or less.

[0009] In an embodiment, the fixing adhesive is a low odor acrylic adhesive. In an embodiment, at room temperature, the complete curing time is 8 to 24 hours, and the shear strength is 20.000 MPa or more and 30.000 MPa or less. For example, the acrylic adhesive can have a shear strength of 28.959 MPa.

[0010] In an embodiment, the sealing element comprises an O-ring disposed in the circumferential gap between the female and male parts and surrounding the male part. The O-ring is an elastic plastic ring that surrounds the male part within the circumferential gap between the female and male parts. The O-ring can form the sealing element as an independent element, but can also form the sealing element together with the sealing adhesive. When used together with the sealing adhesive, the O-ring is a reinforcement for the sealing element, and the sealing adhesive helps to keep the sealing element in intimate sealing contact with the male and female parts. The O-ring can additionally or alternatively be disposed next to the fastening adhesive and form a barrier that helps to prevent the sealing adhesive from penetrating further into the housing.

[0011] In an embodiment, the fixing adhesive discontinuously surrounds the male part in the circumferential gap between the female part and the male part. The fixing adhesive can at least partially fill the gap between the male part and the female part to continuously or discontinuously surround the male part. In the sense of the present invention, a discontinuously surrounding fixing adhesive comprises a plurality of separate fixing adhesive elements separated from each other along the periphery of the male part in the gap. Each of the separate fixing adhesive elements contacts the male part and the female part, thereby fixing the male part and the female part together. According to an embodiment, the sum of the lengths of each of the separate fixing adhesive elements is greater than 40% of the periphery of the male part along the line of the separate fixing adhesive elements. In an embodiment, the sum of the lengths of each of the separate fixing adhesive elements is greater than 50% of the periphery of the male part along the line of the separate fixing adhesive elements. The sum of the lengths of each of the separate fixing adhesive elements can be less than 80% or 70% of the periphery of the male part along the line of the separate fixing adhesive elements.

[0012] In an embodiment, the discontinuous surrounding fastening adhesive is uniformly distributed along the periphery of the male part, thus the separate fastening adhesive elements are uniformly distributed along the perimeter of the male part within the gap.

[0013] In an embodiment, the circumferential gap is formed by a circumferential recess in the male part and / or a circumferential recess in the female part. Thus, the gap may be formed by a recess in the male part extending along the periphery of the male part. Alternatively, the gap may be formed by a recess in the female part extending along the inner periphery of the female part. Still alternatively, the gap may be formed by both a recess in the female part extending along the inner periphery of the female part facing the male part, and a recess in the male part extending along the outer periphery of the male part facing the female part.

[0014] According to an embodiment, the male part comprises a free end facing away from the first housing part, and the sealing element is located closer to the free end than the fixing adhesive. From the free end towards the insertion direction of the male part, the sealing element is arranged closer to the free end than the fixing adhesive. The sealing element forms the outer boundary and the fixing adhesive is arranged internally with respect to the sealing element. When the male part is at least partially inserted into the female part, the free end of the male part can protrude from the female part or be flush with the female part. As mentioned above, the sealing element can include or be formed by the sealing adhesive.

[0015] In an embodiment, the first housing part and the second housing part form a watertight compartment. By forming a watertight compartment, the sealing element forms a watertight seal that prevents the ingress of water through a gap between the male part and the female part.

[0016] In an embodiment, in cross-sectional view, the circumferential gap forms a circular, rectangular, quadratic or elliptical shape surrounding the male part. Each circular, rectangular, quadratic or elliptical shape surrounding the male part is formed by an inner wall of the female part facing the male part. When viewed in cross-sectional view, the inner wall of the female part forms the outer boundary of the circumferential gap.

[0017] In an embodiment, in a cross-sectional view of the body wearable medical device, the rectangular or elliptical shape formed by the circumferential gap includes a first stretch in one direction and a second stretch in a second direction, the first stretch being at least 1.5 times greater than the second stretch in the second direction. In an embodiment, the first stretch is at least 2 times greater than the second stretch in the second direction. In an embodiment, the first stretch is at least 3 times greater than the second stretch in the second direction. The first and second directions are perpendicular to each other.

[0018] According to an embodiment, the body wearable medical device is a drug delivery device, in particular an insulin delivery device, such as an insulin pen or an insulin infusion pump. The body wearable medical device may be a continuous glucose monitor or a body wearable medical device configured to analyze a body fluid. The body wearable medical device may comprise a plaster and / or an adhesive layer configured to temporarily adhere the body wearable medical device to the patient's body. The body wearable medical device may comprise a transcutaneous element, such as a cannula, a probe or a sensor. The probe is configured to collect the body fluid and the sensor is configured to analyze the body fluid.

[0019] 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]

[0020] [Figure 1] 1 is a schematic longitudinal cross-sectional view of a body wearable medical device according to an embodiment of the present invention. [Diagram 2] 2 is a schematic cross-sectional view of the body wearable medical device according to FIG. 1. [Diagram 3] 1 is a schematic longitudinal cross-sectional view of a body wearable medical device according to a further embodiment of the present invention. [Figure 4] 4 is a schematic cross-sectional view of the body wearable medical device according to FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Figures 1 and 2 show a body wearable medical device 1 according to a first embodiment of the present invention. Figure 1 shows a schematic longitudinal cross-sectional view of the body wearable medical device 1, and Figure 2 shows a schematic cross-sectional view of the body wearable medical device 1 along line AA.

[0022] The body wearable medical device 1 comprises a first housing part 2 and a second housing part 3. The first housing part 2 comprises a female part 2a and the second housing part 3 comprises a male part 3a. The male part 3a is at least partially inserted into the female part 2a, i.e. the female part 2a forms a receiving part for receiving the male part 3a of the second housing part 3.

[0023] The gap 4 is provided between the male part 3a and the female part 2a, and the gap 4 surrounds the male part 3a. Here, in this embodiment, the gap 4 is at least partially formed by the circumferential recess 3b of the male part 3a and the circumferential recess 2b of the female part 2a. The circumferential recess 3b of the male part 3a and the circumferential recess 2b of the female part 2a face each other.

[0024] The female part 2a and the male part 3a are fixed to one another by a fixing adhesive 6, which is uniformly distributed in the gap 4 along the periphery of the male part 3a. Next to the fixing adhesive a sealing element 5, here a sealing adhesive, is provided in the gap 4. The sealing element 5 is distributed continuously along the periphery of the male part 3a and is in sealing contact with the female part 2a and the male part 3a.

[0025] The second housing part 3, i.e. the housing part with the male part 3a, has a free end 3c facing away from the first housing part 2, i.e. the housing part with the female part 2a. The sealing element 5 is arranged closer to the free end 3c than the fixing adhesive 6. In the insertion direction of the male part 3a into the female part 2b, the sealing element 5 forms the outer boundary and the fixing adhesive 6 forms the inner fixing means for holding the male part 3a in a fixed position relative to the female part 2a.

[0026] The first housing part 2 and the second housing part 3 together form a watertight compartment 8 .

[0027] A second embodiment of the body wearable medical device 1 is shown by Figures 3 and 4. Figure 3 shows a longitudinal section of the body wearable medical device 1 and Figure 4 shows a section of the body wearable medical device 1 along line BB.

[0028] The body wearable medical device 1 according to FIGS. 3 and 4 differs from the body wearable medical device 1 according to the embodiment of FIGS. 1 and 2 by having a different configuration of the fixing adhesive 6.

[0029] The fixing adhesive 6 discontinuously surrounds the male part 3a within the circumferential gap 4 between the female part 2a and the male part 3a. The fixing adhesive 6 is formed by a plurality of fixing adhesive elements that are uniformly distributed along the circumference of the male part 3a. The plurality of fixing adhesive elements forming the fixing adhesive 6 are shown by dashed lines in the cross-sectional view of Figure 4 for illustrative purposes only, as the fixing adhesive elements are located under the sealing element 5 and are not visible in the cross-section along line BB.

[0030] The circumferential gap 4 forms a rectangle-like shape with a first stretch 9 in a first direction and a second stretch 10 in a second direction. The first stretch is at least 1.5 times, here 2 times, larger than the second stretch 10 in the second direction. The first and second directions are parallel to each other. [Explanation of symbols]

[0031] 1. Wearable medical devices 2 First housing part 2a female part 2b Circumferential recess of female part 3 Second housing part 3a male part 3b Circumferential recess of male part 3c Free end of male part 4 Circumferential clearance 5 Circumferential sealing elements 6 Circumferential Fixing Adhesive 7 O-ring 8 Plots 9. First stretching in a first direction 10 Second stretching in a second direction

Claims

1. A body-wearable medical device (1) comprising a first housing portion (2) and a second housing portion (3), wherein the first housing portion (2) has a female portion (2a) and the second housing portion (3) has a male portion (3a), the male portion (3a) being at least partially inserted into the female portion (2a) thereby defining a circumferential gap (4), and a circumferential sealing element (5) being disposed in the circumferential gap (4) between the female portion (2a) and the male portion (3a), The body-wearable medical device (1) is characterized in that the female part (2a) and the male part (3a) are fixed to each other by a circumferential fixing adhesive (6) disposed in the circumferential gap (4) between the female part (2a) and the male part (3a) next to the circumferential sealing element (5).

2. 2. The body wearable medical device (1) according to claim 1, characterized in that the sealing element (5) is a sealing adhesive having a lower modulus of elasticity than the fixing adhesive (6).

3. 3. The body-wearable medical device (1) according to claim 1 or 2, characterized in that the sealing element (5) comprises an O-ring (7) arranged in the circumferential gap (4) between the female part (2a) and the male part (3a) and surrounding the male part (3).

4. 3. The body-wearable medical device (1) according to claim 1 or 2, characterized in that the fixing adhesive (6) discontinuously surrounds the male part (3a) within the circumferential gap (4) between the female part (2a) and the male part (3a).

5. 5. The body wearable medical device (1) according to claim 4, characterized in that the discontinuous surrounding fixing adhesive (6) is uniformly distributed along the periphery of the male part (2a).

6. 3. The body-wearable medical device (1) according to claim 1 or 2, characterized in that the circumferential gap (4) is formed by a circumferential recess (3b) in the male part (3a) and / or a circumferential recess (2b) in the female part (2a).

7. 3. The body-wearable medical device (1) according to claim 1 or 2, characterized in that the second housing part (3) has a free end (3c) facing away from the first housing part (2), and the sealing element (5) is located closer to the free end (3c) than the fixing adhesive (6).

8. 3. The body wearable medical device (1) according to claim 1 or 2, characterized in that the first housing part (2) and the second housing part (3) form a watertight compartment (8).

9. 3. The body wearable medical device (1) according to claim 1 or 2, characterized in that in cross section, the circumferential gap (4) forms a rectangular or oval shape surrounding the male part (3a).

10. 10. The body wearable medical device (1) of claim 9, characterized in that the rectangular or oval shape comprises a first extension (9) in one direction and a second extension (10) in a second direction, the first extension (9) being at least 1.5 times greater than the second extension (10) in the second direction.

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