APPARATUS FOR INSERTING A MEDICAL DEVICE INTO A BODY TISSUE

Abstract

An apparatus for medical purposes is disclosed. The apparatus includes a medical device configured to be at least partially insertable into body tissue of a user. It also includes an inserter configured for at least partially inserting the medical device into the body tissue. A housing has a removable cap connected thereto, and the removable cap is removed from the housing before insertion of the medical device. A flexible connector connects the removable cap to the housing, the flexible connector being reversibly displaceable from a locking position in which the removable cap is secured to the housing and a releasing position in which the removable cap is released from the housing. A frangible securing element secures the flexible connector into the locking position prior to use. Further, methods for preparing the apparatus and inserting the medical device into the body tissue of the user are disclosed.

Claims

1. An apparatus, comprising: a medical device configured to be at least partially insertable into a body tissue of a user; an inserter configured for at least partially inserting the medical device into the body tissue; a housing; a removable cap connected to the housing and configured for being removed from the housing before insertion of the medical device; a flexible connector connecting the removable cap to the housing, the flexible connector being reversibly displaceable from a locking position in which the removable cap is secured to the housing and a releasing position in which the removable cap is released from the housing; and a frangible securing element that secures the flexible connector into the locking position prior to use.

2. The apparatus according to claim 1, wherein: the flexible connector is movable from the locking position into the releasing position by applying a manual force; the frangible securing element is configured for being destroyed by the manual force; and the manual force is applied in a direction that is different from the direction of the force required for removing the removable cap from the housing.

3. The apparatus according to claim 1, wherein the flexible connector is at least partially integrated into one of the removable cap and the housing and is further configured for remaining with the removable cap or the housing, respectively, after removing the removable cap from the housing.

4. The apparatus according to claim 1, wherein the flexible connector is flexibly displaceable by at least one of manually pressing, twisting or pulling the flexible connector.

5. The apparatus according to claim 1, wherein the flexible connector comprises at least one of a flexible tongue, a hook, a catch or a pin.

6. The apparatus according to claim 1, wherein the flexible connector comprises a flexible tongue having a free end and a fixed end, the fixed end being connected to one of the housing and the removable cap, wherein the frangible securing element secures the flexible tongue in the locking position.

7. The apparatus according to claim 1, wherein: the flexible connector is movable from the locking position into the releasing position in a releasing direction; the removable cap is, during removal from the housing, movable in a removing direction; and the releasing direction is different from the removing direction.

8. The apparatus according to claim 1, wherein (i) moving the flexible connector from the locking position into the releasing position and (ii) removing the removable cap from the housing require separate mechanical actions by the user.

9. The apparatus according to claim 1, wherein removing the removable cap from the housing requires a twisting motion of the removable cap.

10. The apparatus according to claim 1, wherein the medical device comprises at least one of an infusion set for delivery of at least one therapeutic fluid into a body tissue of a user, and an analyte sensor for detecting at least one analyte in a body fluid.

11. The apparatus according to claim 1, wherein the inserter comprises at least one actuator for driving the medical device into the body tissue, wherein the inserter comprises at least one part of the housing, wherein the housing comprises at least one stationary portion configured for resting on the skin of the user and at least one actuation portion configured for being manually actuated by the user for actuating the actuator, wherein the stationary portion and the actuation portion are movable with respect to each other.

12. The apparatus according to claim 1, further comprising a preassembled functional module having the medical device and at least one of the following components: a penetrating member for inserting the medical device into the body tissue, an infusion cannula for delivery of a therapeutic fluid into a body tissue of a user, an analyte sensor, and an electronics unit electrically connected to the medical device.

13. The apparatus according to claim 12, wherein the preassembled functional module comprises a protective cap, wherein removing the removable cap removes the protective cap from the preassembled functional module.

14. The apparatus of claim 13, wherein, prior to use, the protective cap provides a sterile enclosure for at least part of the penetrating member.

15. The apparatus of claim 13, wherein removing the removable cap exposes the penetrating member for insertion into the body tissue.

16. The apparatus of claim 12, wherein, prior to use, the protective cap provides a sterile enclosure for at least a portion of an analyte sensor.

17. A method for preparing the apparatus according to claim 1 for insertion of at least a part of the medical device into a body tissue of a user, the method comprising displacing the flexible connector from the locking position into the releasing position and thereby at least partially destroying the frangible securing element, the method further comprising removing the removable cap from the housing.

18. The method of claim 17, wherein removing the removable cap removes a protective cap from a preassembled functional module.

19. The method of claim 17, further comprising placing a distal end of the housing onto the skin of the user and actuating the inserter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0143] The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:

[0144] FIG. 1 shows a schematic embodiment of an apparatus in a cross-sectional view;

[0145] FIG. 2 shows the embodiment of the apparatus with a removable cap connected to the housing in a perspective view;

[0146] FIG. 3 shows the embodiment of the apparatus without the removable cap in a perspective view;

[0147] FIG. 4 shows the removable cap of the embodiment of the apparatus in a perspective view;

[0148] FIG. 5 shows a first embodiment of a flexible connection element in a cross-sectional view;

[0149] FIG. 6 shows a second embodiment of the flexible connection element in a cross-sectional view;

[0150] FIG. 7 shows a third embodiment of the flexible connection element in a cross-sectional view;

[0151] FIG. 8 shows a flow chart of an embodiment of a method for preparing the apparatus for insertion of at least a part of a medical device into a body tissue of a user; and

[0152] FIG. 9 shows a flow chart of an embodiment of a method for at least partially inserting at least a part of the medical device of the apparatus into the body tissue of the user.

DESCRIPTION

[0153] The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.

[0154] In FIG. 1, an exemplary embodiment of an apparatus 110 is shown in a cross-sectional view. The apparatus 110 may specifically be a medical system 112. The apparatus 110, specifically the medical system 112, comprises: [0155] a. a medical device 114 which is at least partially insertable into a body tissue of a user; [0156] b. an insertion device 116 for at least partially inserting the medical device 114 into the body tissue; [0157] c. a housing 118; and [0158] d. a removable cap 120 connected to the housing 118, the removable cap 120 being configured for being removed from the housing 118 before insertion of the medical device 114.

[0159] The housing 118 and the removable cap 120, prior to removal of the removable cap 120, are connected via at least one flexible connection element 122 (also referred to as a “flexible connector”). The flexible connection element 122 is reversibly displaceable from a locking position in which the removable cap 120 is secured to the housing 118 by the flexible connection element 122 into a releasing position in which the removable cap 120 is released. An example of the locking position and the releasing position will be given with respect to FIG. 5 below. The flexible connection element 122, prior to use, is secured in the locking position by at least one frangible securing element 124. The frangible securing element 124 is not visible in FIG. 1. An exemplary embodiment of the frangible securing element 124 is shown, for example, in FIGS. 5 to 7.

[0160] The apparatus 110 may comprise at least one element configured for performing at least one medical function and/or for being used in at least one medical process. For example, the apparatus 110 comprises the medical device 114 which may be configured for performing the at least one medical function and/or for being used in the medical process. Further, the apparatus 110 may comprise components which may provide an insertion mechanism, such as components configured for inserting the medical device 114 into the body tissue of the user. For example, the apparatus 110 comprises the at least one insertion device 116 for at least partially inserting the medical device 114 into the body tissue. The apparatus 110 specifically may be configured for performing at least one of the following actions: the action of inserting the medical device 114 into the body tissue; the action of detecting at least one analyte in the body fluid by using an analyte sensor 128; the action of delivering of at least one therapeutic fluid into the body tissue.

[0161] The medical device 114 may comprise at least one of a device 126 for delivery of the at least one therapeutic fluid and an analyte sensor 128 for detecting the at least one analyte. Specifically, the device 126 for delivery of the therapeutic fluid may be or may comprise at least one infusion set 130 comprising at least one infusion cannula 132. The analyte sensor 128 may be an analyte sensor 128 for detecting at least one bodily analyte in at least one bodily fluid present in the body tissue of the user. More specifically, the analyte sensor 128 may be at least one electrochemical analyte sensor comprising at least one sensor electrode for detecting the at least one analyte.

[0162] The medical device 114 may be at least partially accommodated within the housing 118. The medical device 114 may be comprised by at least one preassembled functional module 134 of the apparatus 110, specifically by at least one penetrating cartridge. The preassembled functional module 134 may comprise, besides the medical device 114, specifically besides the analyte sensor 128, at least one of the following components: at least one penetrating member 136 for inserting the medical device 114 into the body tissue, more specifically at least one insertion needle; the at least one infusion cannula 132 for delivery of at least one therapeutic fluid into a body tissue of a user; at least one electronics unit 138 electrically connected to the medical device 114, specifically at least one electronics unit 138 for sensing the at least one analyte in conjunction with the at least one analyte sensor 128. The medical device 114 may comprise at least one portion which is at least one of transcutaneously or subcutaneously insertable into the body tissue.

[0163] The insertion device 116 may be configured for moving the preassembled functional module 134 towards the skin of the user, specifically resulting in the at least partial insertion of the medical device 114 into the body tissue. The preassembled functional module 134 may further comprise at least one protective cap 140, specifically at least one sterility cap. The protective cap 140 may provide a sterile surround for the medical device 114 and/or the penetrating member 136. The apparatus 110 may be configured such that removing the removable cap 120 removes the protective cap 140 from the preassembled functional module 134, specifically by twist-off.

[0164] The insertion device 116 may comprise at least one actuator 142 for driving the medical device 114 into the body tissue of the user. Specifically, the insertion device 116 may comprise at least one actuable displacement mechanism 144 which upon actuation is capable of driving and/or protracting the medical device 114 towards the body tissue of the user. The driving and/or protraction may result in the at least partial insertion of the medical device 114 into the body tissue of the user. The actuator 142 may be a manual actuator 142 which is manually actuable by the user.

[0165] Further, the actuator 142 may comprise at least one of the following: an insertion spring for driving the medical device 114 into the body tissue of the user; a return spring 146 for retracting the penetrating member 136 from the body tissue after insertion, specifically by leaving the medical device 114 in place. The insertion spring is not visible in the apparatus 110 shown in FIG. 1. The return spring 146 may be configured for retracting the penetrating member 136 from the body tissue of the user, specifically after insertion of the medical device 114.

[0166] The penetrating member 136 may be part of the apparatus 110, specifically of the insertion device 116. The penetrating member 136 may be configured for inserting the medical device 114 into the body tissue. When retracting the penetrating member 136, for example, by using the return spring 146, the penetrating member 136 may be configured for leaving the medical device 114 in the body tissue.

[0167] The insertion device 116, specifically the actuator 142, may comprise at least one part of the housing 118. The housing 118 may comprise at least one stationary portion 148 configured for resting on the skin of the user. The housing 118 may further comprise at least one actuation portion 150 configured for being manually actuated by the user for actuating the actuator 142. The stationary portion 148 and the actuation portion 150 may be movable with respect to each other. The stationary portion 148 and the actuation portion 150 each may comprise cylindrical parts which are concentrically disposed with respect to a longitudinal axis 152 of the apparatus 110. The housing 118 may be at least partially cylindrical with respect to the longitudinal axis 152 of the apparatus 110.

[0168] The removable cap 120 may be connected to the housing 118 by a twistable connection 154, specifically by at least one screw coupling 156. At least one of the removable cap 120 and the housing 118 may comprise at least one screw thread 158. Specifically, both of the housing 118 and the removable cap 120 may comprise screw threads 158 corresponding to each other, such that the screw threads 158 may form the twistable connection 154 between the housing 118 and the removable cap 120. The removable cap 120 may be at least partially cylindrical. Specifically, the removable cap 120 may be located concentrically with respect to the longitudinal axis 152 of the apparatus 110.

[0169] The flexible connection element 122 may be at least partially integrated into one of the removable cap 120 and the housing 118. The flexible connection element 122 will be described in further detail below, with reference to FIGS. 2 and 5 to 7.

[0170] In FIGS. 2 to 4, several perspective views of the apparatus 110 are shown which will be explained in further detail and in conjunction below. Therein, the interior of the apparatus 110 may be embodied as explained above in the context of FIG. 1. It shall be noted, however, that other embodiments of the apparatus 110 are also feasible in conjunction with FIGS. 2 to 4, such as other embodiments of the medical device 114 and/or of the insertion device 116.

[0171] Therein, FIG. 2 shows an exemplary embodiment of the apparatus 110 with the removable cap 120 connected to the housing 118 in a perspective view. The housing 118 and the removable cap 120 are connected via the at least one flexible connection element 122. Specifically, the housing 118 and the removable cap 120, prior to removal of the removable cap 120, may be locked to each other by at least one of a force-fit or a form-fit connection. As in FIG. 1, the removable cap 120 may be connected to the housing 118 by a twistable connection 154, which is not visible in FIG. 2.

[0172] As outlined above, the flexible connection element 122 is reversibly displaceable from the locking position in which the removable cap 120 is secured to the housing 118 by the flexible connection element 122 into the releasing position in which the removable cap 120 is released. The flexible connection element 122, prior to use, is secured in the locking position by the at least one frangible securing element 124. In FIG. 2, the flexible connection element 122 is in the locking position and, thus, the removable cap 120 is secured to the housing 118.

[0173] The frangible securing element 124 may comprise at least one frangible ligament 160 securing at least part of the flexible connection element 122 in the locking position. Specifically, the frangible securing element 124 may secure the flexible connection element 122 in the locking position to the removable cap 120. The flexible connection element 122 may be movable form the locking position into the releasing position The frangible securing element 124 may be configured for being destroyed when the flexible connection element 122 is moved from the locking position into the releasing position. A direction of motion of the flexible connection element 122 from the locking position into the releasing position may be different from a direction of a force required for removing the removable cap 120 from the housing 118. As can be seen in FIG. 2, the apparatus 110, specifically the housing 118 and the removable cap 120, may have a cylindrical shape and, thus, may extend along the longitudinal axis 152. The direction of motion of the flexible connection element 122 from the locking position into the releasing position may be a radial direction with respect to the longitudinal axis 152 of the apparatus 110. The direction of force required for removing the cap may comprise a direction perpendicular to the radial direction, such as a longitudinal direction with respect to the longitudinal axis 152 or a rotational direction about the longitudinal axis 152. The flexible connection element 122 may be configured, due to its elastic properties, for returning from the releasing position into the locking position by an elastic force.

[0174] The flexible connection element 122 may comprise at least one force application surface 162 accessible to the user. A manual force may be applicable via the force application surface 162. Specifically, the force application surface 162 may comprise an indentation 164 in an outer surface 166 of the apparatus 110. The indentation 164 may be configured for receiving a finger tip of the user. The flexible connection element 122 may be flexibly displaceable by at least one of manually pressing, twisting or pulling the flexible connection element 122.

[0175] Further, the flexible connection element 122 may be at least partially integrated into one of the removable cap 120 and the housing 118. In the exemplary embodiment shown in FIG. 2, the flexible connection element 122 may be integrated into the removable cap 120. The flexible connection element 122 may further be configured for remaining with the removable cap 120 or the housing 118, respectively, after removing the removable cap 120 from the housing 118.

[0176] In the exemplary embodiment of FIG. 2, the flexible connection element 122 may comprise at least one flexible tongue 168. The flexible tongue 168 may comprise at least one free end 170 and at least one fixed end 172. The fixed end 172 may be connected to one of the housing 118 and the removable cap 120. The free end 170 may be configured for engaging with at least one of the housing 118 and the removable cap 120. The frangible securing element 124 may secure the flexible tongue 168 in the locking position.

[0177] The flexible tongue 168 may be at least partially received within a slot 174 of one of the housing 118 and the removable cap 120. The frangible securing element 124 may secure the flexible tongue 168 to at least one edge 176 of the slot 174. As can be seen in FIG. 2, the flexible tongue 168 may, as an example, be received within the slot 174 of the removable cap 120.

[0178] Specifically, the flexible connection element 122 may be part of the removable cap 120 and may be configured to engage with housing 118 in the locking position. The flexible connection element 122 may be flexibly displaceable into the releasing position by disengaging with the housing 118.

[0179] The apparatus 110 may be configured such that bringing the flexible connection element 122 from the locking position into the releasing position and removing of the removable cap 120 from the housing 118 may require separate mechanical actions by the user. Specifically, the removable cap 120 may be configured such that removing the removable cap 120 from the housing 118 may require a twisting motion of the removable cap 120, specifically a twisting motion of the removable cap 120 about the longitudinal axis 152 of the apparatus 110. Additionally, bringing the flexible connection element 122 from the locking position into the releasing position may require a mechanical action of applying the manual force to the flexible connection element 122, such as by manually pressing, twisting or pulling the flexible connection element 122.

[0180] FIG. 3 shows an exemplary embodiment of the apparatus 110 without the removable cap 120 in a perspective view. As can be seen in FIG. 3, the removable cap 120 has been removed from the housing 118 of the apparatus 110. The housing 118 of the apparatus 110 may comprise the actuation portion 150 at least partially surrounding the stationary portion 148 of the housing 118. The medical device 114 may be comprised by the preassembled functional module 134. The preassembled functional module 134 may be received within the stationary portion 148 of the housing 118. The preassembled functional module 134 may further comprise the penetrating member 136. The penetrating member 136 may be part of the apparatus 110, specifically of the insertion device 116. The penetrating member 136 may protrude from the preassembled functional module 134, specifically pointing towards the skin of the user.

[0181] As outlined above, the flexible connection element 122 may be connected to, specifically integrated into, one of the housing 118 and the removable cap 120. In the exemplary embodiment shown in FIG. 2, the flexible connection element 122 may be connected to the removable cap 120 and may remain with the removable cap 120 after removing the removable cap 120 from the housing 118. Further, the other one of the housing 118 and the removable cap 120 may comprise at least one depression 178. In the exemplary embodiment shown in FIG. 3, the housing 118 may comprise the depression 178. The depression 178 may be configured for engaging with the flexible connection element 122 in the locking position.

[0182] The housing 118 may further comprise at least one sheath 180 with a distal side 182 facing the skin of the user and a proximal side 184 facing away from the user. The removable cap 120 may cover at least the distal side 182 of the housing 118 prior to placement of the apparatus 110 onto the skin of the user, specifically prior to removal of the removable cap 120. The insertion device 116 may be configured for placement onto the skin of the user, specifically by a circumferential rim 186 of the housing 118.

[0183] In FIG. 4, an exemplary embodiment of the removable cap 120 is shown in a perspective view. The removable cap 120 may be configured such that removing the removable cap 120 from the housing 118 may require the twisting motion. For example, the removable cap 120 may comprise the at least one screw thread 158. The removable cap 120 may be connected to the housing 118 by the twistable connection 154, specifically by at least one screw coupling 156.

[0184] In the exemplary embodiment shown in FIG. 4, the flexible connection element 122 may be at least partially integrated into the removable cap 120. The flexible connection element 122 may comprise the at least one flexible tongue 168. The removable cap 120 may comprise the at least one slot 174, wherein the slot 174 may be configured for at least partially receiving the flexible tongue 168. The frangible securing element 124 may secure the flexible tongue 168 to the at least one edge 176 of the slot 174.

[0185] As outlined above in the context of FIG. 1, the preassembled functional module 134 may comprise the at least one protective cap 140. The preassembled functional module 134 with the protective cap 140 may be received within the housing 118 and, thus, is not visible in FIG. 4. The removable cap 120 may comprise at least one inner contour 188. The inner contour 188 of the removable cap 120 may be configured for engaging with an outer contour of the protective cap 140.

[0186] The removable cap 120 may be configured for being removed from the housing 118 by a rotational movement. The removable cap 120 may further be configured for transferring a torque onto the protective cap 140 during removal. The protective cap 140 may be removed from the preassembled functional module 134 by the torque transferred from the inner contour 188 of the removable cap 120 to the outer contour of the protective cap 140.

[0187] The apparatus 110 may further comprise at least one removable protective cap, specifically at least one removable protective cap connected to the preassembled functional module 134. The cylindrical removable cap may be configured for removing the removable protective cap when being removed from the housing 118. The cylindrical removable cap may comprise at least one engaging contour for engaging with a corresponding contour of the removable protective cap.

[0188] FIGS. 5 to 7 show various embodiments of the flexible connection element 122 in a cross-sectional view. These embodiments may be implemented, as an example, in the embodiments of the apparatus 110 as shown above. It shall be noted, however, that other embodiments of the apparatus 110 are also feasible.

[0189] Therein, FIG. 5 shows a first exemplary embodiment of the flexible connection element 122 in a cross-sectional view. As outlined above, the apparatus 110 comprises the housing 118 and the removable cap 120, wherein the housing 118 and the removable cap 120, prior to removal of the removable cap 120, are connected via the flexible connection element 122. In the exemplary embodiment shown in FIG. 5, the flexible connection element 122 may be integrated into the removable cap 120, which is not visible in FIG. 5. The frangible securing element 124 may secure the flexible connection element 122 to the removable cap 120.

[0190] The flexible connection element 122 shown in solid lines in FIG. 5 is in the locking position, as denoted symbolically by reference number 216. Generally, the locking position 216 may also be referred to as a “locking configuration.” The flexible connection element 122 may be received within the at least one depression 178 of one of the removable cap 120 and the housing 118. In the exemplary embodiment shown in FIG. 5, in the locking position 216, the flexible connection element 122 may be received in the depression 178 of the housing 118. The frangible securing element 124 may secure the flexible connection element 122 in the locking position 216. Specifically, the frangible securing element 124 may prevent movement of the flexible connection element 122.

[0191] As outlined above, the flexible connection element 122 may be movable from the locking position 216 into the releasing position by applying the manual force. In FIG. 5, the manual force is symbolically denoted by arrow 190. The releasing position of the flexible connection element 122, which generally also may be referred to as a “releasing configuration,” is indicated by dashed lines and by symbolic reference number 218. It shall be noted that, in the following embodiments of FIGS. 6 and 7, the releasing configuration is not depicted. The skilled person, however, will recognize that the releasing configuration may be embodied analogously to the embodiment of FIG. 5.

[0192] The flexible connection element 122 may be movable, upon application of the manual force 190, back and forth in a direction perpendicular to the longitudinal axis 152, as depicted in FIGS. 1 and 2, of the apparatus 110, specifically into the releasing position 218. The manual force 190 may be applied by the user of the apparatus 110. The frangible securing element 124 may be configured for being destroyed by the manual force 190. A direction of the manual force 190 may be different from a direction of a force required for removing the removable cap 120 from the housing 118.

[0193] The flexible connection element 122 may be movable from the locking position 216 into the releasing position 218 in a releasing direction 192. The releasing direction 192 is indicated in FIG. 5 by a bent arrow pointing in the direction of releasing, wherein the curvature of the arrow may follow the trajectory of an arbitrary point or element of the flexible connection element 122 during movement. For example, the releasing direction 192 may essentially be a radial direction with respect to the longitudinal axis 152 of the apparatus 110. The removable cap 120 may be, during removing from the housing 118, movable into at least one removing direction 193. The releasing direction 192 may be different from the removing direction 193. For example, the removing direction 193 may comprise a direction perpendicular to the releasing direction 192, such as a direction parallel to the longitudinal axis 152 of the apparatus 110 or a rotational direction about the longitudinal axis 152.

[0194] In case the user applies the manual force 190 to the flexible connection element 122, the frangible securing element 124 may be destroyed. The manual force 190 required to destroy the frangible securing element 124 may be adjustable by a structure and/or a material selection of the frangible securing element 124. When the frangible securing element 124 is destroyed, it may be possible to displace the flexible connection element 122 from the locking position 216 into the releasing position 218, for example, by moving the flexible connection element 122 from the locking position 216 into the releasing position 218 and/or by deforming the flexible connection element 122.

[0195] In the releasing position 218, the flexible connection element 122 may release the twisting motion of the removable cap 120. In the exemplary embodiment shown in FIG. 5, the flexible connection element 122 may disengage with the depression 178 of the housing 118 and, thus, may release a relative motion of the housing 118 and the removable cap 120. In the releasing position 218 of the flexible securing element 122, a rotational motion and/or a translational movement of the removable cap 120 relative to the housing 118 may be possible.

[0196] A second exemplary embodiment of the flexible connection element 122 shown in a cross-sectional view in FIG. 6 may correspond widely to the first embodiment of the flexible connection element 122 shown in FIG. 5. Thus, reference may be made to the description of FIG. 5. In the exemplary embodiment shown in FIG. 6, the flexible connection element 122 may comprise at least one of a hook 194 or a catch 196. In the locking position 216, additionally or alternatively, the flexible connection element 122 may engage with the depression 178 and prevent a translational motion of the housing 118 and/or the removable cap 120. However, other embodiments, structures or forms may be possible, such as a trapezium-shaped flexible connection element 122 or other geometries of the flexible connection element 122 restricting the translational motion of the housing 118 and/or the removable cap 120.

[0197] In the releasing position 218, which is not depicted in FIG. 6, the flexible connection element 122 may disengage with the depression 178 in the housing 118. Thus, the flexible connection element 122 may release the translational motion of the housing 118 and/or the removable cap 120 in the releasing position 218. In the exemplary embodiment shown in FIG. 6, the flexible connection element 122 may disengage with the depression 178 of the housing 118 and, thus, may release a relative motion of the housing 118 and the removable cap 120.

[0198] In FIG. 7, a third exemplary embodiment of the flexible connection element 122 is shown in a cross-sectional view. Therein, the flexible connection element 122 may comprise at least one pin 198. Additionally, the apparatus 110 may comprise at least one additional structure 200 configured for indirectly displacing the flexible connection element 122. The additional structure 200 may be configured for inverting the releasing direction 192. The additional structure 200 may further be configured for spatially separating the functionalities of the flexible connection element 122.

[0199] In the exemplary embodiment shown in FIG. 7, the manual force 190 may comprise pulling the pin 198 of the flexible connection element 122. The frangible securing element 124 may be destroyed by moving the flexible connection element 122 from the locking position 216 into the releasing position 218. In the releasing position 218, a relative movement of the housing 118 and the removable cap 120 may be released. The additional element 200 may be in contact with a pivotal point 202. By the interaction of the additional element 200 and the pivotal point 202, the releasing direction 192 may be inverted. The interlocking of the removable cap 120 and the housing 118 may be released in the releasing position 218.

[0200] FIG. 8 shows a flow chart of an exemplary embodiment of a method for preparing the apparatus 110 for insertion of at least a part of the medical device 114 into the body tissue of the user. The method comprises the following steps, which may specifically be performed in the given order. Still, a different order may also be possible. It may be possible to perform two or more of the method steps fully or partially simultaneously. It may further be possible to perform one, more than one or even all of the method steps once or repeatedly. The method may comprise additional method steps that are not listed.

[0201] The method comprises preparing the apparatus 110 (denoted by reference number 204) according to this disclosure, such as according to any one of the embodiments disclosed above and/or any one of the embodiments disclosed in further detail below, for insertion. In a first optional step, the method may comprise providing the apparatus 110 (denoted by reference number 206). The method further comprises displacing the flexible connection element 122 from the locking position 216 into the releasing position 218 (denoted by reference number 208), thereby at least partially destroying the frangible securing element 124. The method further comprises removing the removable cap 120 from the housing 118 (denoted by reference number 210).

[0202] In FIG. 9, a flow chart of an exemplary embodiment of a method for at least partially inserting at least a part of the medical device 114 of the apparatus 110 into the body tissue of the user is shown. The method comprises the following steps, which may specifically be performed in the given order. Still, a different order may also be possible. It may be possible to perform two or more of the method steps fully or partially simultaneously. It may further be possible to perform one, more than one or even all of the method steps once or repeatedly. The method may comprise additional method steps that are not listed.

[0203] The method comprises at least partially inserting at least part of the medical device 114 of the apparatus 110 according to this disclosure, such as according to any one of the embodiments disclosed above and/or according to any one of the embodiments disclosed in further detail below. The method comprises preparing the apparatus 110 for insertion (denoted by reference number 204) by using the method according to this disclosure, such as according to any one of the embodiments disclosed above and/or according to any one of the embodiments disclosed in further detail below. The method further comprises placing a distal end of the housing 118 onto the skin of the user (denoted by reference number 212) and actuating the insertion device 116 (denoted by reference number 214).

[0204] While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

TABLE-US-00001 LIST OF REFERENCE NUMBERS 110 apparatus 112 medical system 114 medical device 116 insertion device 118 housing 120 removable cap 122 flexible connection element 124 frangible securing element 126 device for delivery of a therapeutic fluid 128 analyte sensor 130 infusion set 132 infusion cannula 134 preassembled functional module 136 penetrating member 138 electronics unit 140 protective cap 142 actuator 144 actuable displacement mechanism 146 return spring 148 stationary portion 150 actuation portion 152 longitudinal axis 154 twistable connection 156 screw coupling 158 screw thread 160 frangible ligament 162 force application surface 164 indentation 166 outer surface 168 flexible tongue 170 free end 172 fixed end 174 slot 176 edge of the slot 178 depression 180 sheath 182 distal side 184 proximal side 186 circumferential rim 188 inner contour 190 manual force 192 releasing direction 193 removing direction 194 hook 196 catch 198 pin 200 additional element 202 pivotal point 204 preparing the apparatus for insertion 206 providing the apparatus 208 displacing the flexible connection element 210 removing the removable cap 212 placing a distal end of the housing onto the skin of the user 214 actuating the insertion device 216 locking position 218 releasing position