MEDICAL SYSTEM AND METHOD OF STERILITY TESTING THE MEDICAL SYSTEM

Abstract

A medical system is disclosed. The medical system has a housing and a module received in the housing. The module includes an analyte sensor configured for detecting an analyte in a body fluid of a user, an electronics unit electrically connected to the analyte sensor, an insertion component configured for inserting the analyte sensor into body tissue of the user, and a sterility cap at least partially surrounding the insertion component. A removable protective cap is connected to the housing and covers the module. The protective cap at least partially surrounds the sterility cap. The sterility cap has a sterility testing access that has at least one of a septum and a multiple-step sealing. A method of sterility testing the medical system is also disclosed in which a rinsing liquid is inserted into an interior space of the sterility cap and microbial testing of the rinsing liquid is then completed.

Claims

1. A medical system, comprising: a housing; a module received in the housing and comprising: an analyte sensor configured for detecting an analyte in a body fluid of a user, an electronics unit electrically connected to the analyte sensor, an insertion component configured for inserting the analyte sensor into body tissue of the user, and a sterility cap at least partially surrounding the insertion component; a removable protective cap connected to the housing and covering the module, wherein the protective cap at least partially surrounds the sterility cap; and wherein the sterility cap comprises a sterility testing access that has at least one of a septum and a multiple-step sealing.

2. The medical system according to claim 1, wherein the sterility cap comprises the multiple-step sealing and the multiple-step sealing further comprises a plurality of circumferential sealing elements having differing equivalent diameters, the circumferential sealing elements being disposed within an interior space of the sterility cap.

3. The medical system according to claim 1, wherein the sterility cap comprises a tubular sidewall surrounding a sterility testing access opening that is closed by at least one of the septum and a removable stopper.

4. The medical system according to claim 1, wherein the sterility cap is accessible from an outer side of the medical system and wherein the sterility cap is sealed by a removable seal.

5. The medical system according to claim 1, wherein the sterility cap is engaged with the removable protective cap such that when the protective cap is removed from the housing, the sterility cap is removed from the module.

6. The medical system according to claim 1, wherein the sterility cap has at least one side in common with the protective cap.

7. The medical system according to claim 1, wherein the module further comprises a base plate, wherein the sterility cap is connected to the base plate.

8. The medical system according to claim 1, wherein the module further comprises a cover that covers the electronics unit and at least part of the analyte sensor.

9. The medical system according to claim 1, wherein the sterility cap provides a sealed interior space, wherein the analyte sensor and the insertion component are at least partially located within the sealed interior space.

10. The medical system according to claim 1, further comprising a driving actuator configured for driving the insertion component into the body tissue of the user.

11. The medical system according to claim 1, wherein the module further comprises an electrical energy storage device.

12. A method of sterility testing a medical system having a module that has an electronics unit electrically connected to an analyte sensor, an insertion component for inserting the analyte sensor into body tissue of the user, and a sterility cap that at least partially surrounds the insertion component, the method comprising: A) inserting a rinsing liquid into an interior space of the sterility cap; and B) microbial testing of the rinsing liquid.

13. The method according to claim 12, wherein the sterility cap has a sterility testing access, wherein step A) comprises attaching a fluidic adapter to the sterility testing access, wherein the sterility testing access comprises at least one multiple-step sealing, wherein step A) comprises removing at least one stopper from the sterility testing access, the stopper being in contact with a first-step sealing of the multiple-step sealing, step A) further comprising attaching the fluidic adapter to the sterility testing access, wherein the fluidic adapter is in contact with a second-step sealing of the multiple-step sealing, wherein the first-step sealing has a larger equivalent diameter than the second-step sealing.

14. A method of providing the medical system according to claim 1, the method comprising: I. assembling a part of the module that includes the analyte sensor, the insertion component and the sterility cap at least partially surrounding the insertion component; II. sterilizing the part of the module; III. assembling the module, the assembling comprising electrically connecting the electronics unit to the analyte sensor; and IV. assembling the medical system by receiving the module in the housing and connecting the removable protective cap to the housing.

15. The method according to claim 14, the method further comprising storing the medical system.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0176] 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:

[0177] FIGS. 1a-b show an embodiment of a preassembled functional module in a cross-sectional view (FIG. 1a) and in a perspective view (FIG. 1b);

[0178] FIG. 2 shows a first embodiment of a medical system in a cross-sectional view;

[0179] FIGS. 3a-d show a second embodiment of a medical system in cross-sectional views (FIGS. 3a and 3c) and in perspective views (FIGS. 3b and 3d), with a removable stopper (FIGS. 3a and 3b) and with a fluidic adapter (FIGS. 3c and 3d);

[0180] FIG. 4 shows an enlarged view of a sterility cap of the medical system of FIGS. 3a and 3b in a cross-sectional view;

[0181] FIG. 5 shows an enlarged view of the sterility cap of the medical system of FIGS. 3c and 3d in a cross-sectional view;

[0182] FIG. 6 shows a flow chart of an embodiment of a method of sterility testing of a medical system;

[0183] FIG. 7 shows a flow chart of an embodiment of a method of providing a medical system; and

[0184] FIGS. 8a-b show a cross-sectional view (FIG. 8a) and a perspective view (FIG. 8b) of a subgroup forming a part of the preassembled functional module of FIGS. 1a and 1b, ready for sterilization and before assembly with the remaining parts of the functional module.

DESCRIPTION

[0185] 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.

[0186] In FIGS. 1a-b, an exemplary embodiment of a preassembled functional module 110 is shown in a cross-sectional view (FIG. 1a) and in a perspective view (FIG. 1b). The preassembled functional module 110 comprises at least one analyte sensor 112 for detecting at least one analyte in a body fluid of a user. The analyte sensor 112 may be or may comprise an electrochemical sensor and may be configured for continuous monitoring of the analyte in the body fluid of the user. The analyte sensor 112 may be inserted into a body tissue of the user by using an insertion component 114 of the preassembled functional module 110, for example, an insertion cannula or an insertion needle.

[0187] The insertion component 114 is at least partially surrounded by at least one sterility cap 116. The sterility cap 116 surrounds the insertion component 114 and at least a part of the analyte sensor 112, such as a distal part or implantable part thereof. The sterility cap 116 may provide an interior space 118 which specifically may be sterilized and sealed from the outside. The insertion component 114 and at least part of the analyte sensor 112 may be located within the interior space 118.

[0188] The analyte sensor 112 is electrically connected to an electronics unit 120 of the preassembled functional module 110. The electronics unit 120 may be configured for performing at least one electronic function, specifically for performing an analyte measurement, such as by measuring at least one of an electrical current and/or a voltage provided by the analyte sensor 112. Thus, the electronics unit 120 may be configured for receiving an electronic signal, such as an electrical current and/or a voltage, from the analyte sensor 112 and further, optionally, for determining the analyte concentration in the body fluid of the user by using the electrical current and/or the voltage. The preassembled functional module 110 may further comprise at least one electrical energy storage device, for example, a battery, which specifically may be configured for supplying electrical energy to the electronics unit 120.

[0189] Further, the preassembled functional module 110 may comprise at least one base plate 122. The base plate 122, as an example, may be designed as a body mount and may comprise an adhesive surface, such as an adhesive plaster 123, for mounting the base plate 122 to a skin site of the user.

[0190] The sterility cap 116 may be connected to the base plate 122. For example, the base plate 122 and the sterility cap 116 may be manufactured as one single piece, such as by a common molding process. Alternatively, the sterility cap 116 may be connected to the base plate 122 by means of at least one of: a welding technique; a bonding technique; a soldering technique; an adhesive method. The connection between the sterility cap 116 and the base plate 122 may form a predetermined breaking point 124, such as a circumferential breaking line, as will be outlined in further detail below.

[0191] The base plate 122 may be configured for receiving the electronics unit 120 and at least part of the analyte sensor 112, such as a part configured for being inserted into the body tissue of the user. The analyte sensor 112 and the insertion component 114 may penetrate the base plate 122 via at least one through hole 126 from an upper side 128 to a lower side 130 of the base plate 122. On the lower side 130, the sterility cap 116 may surround the through hole 126. On the upper side 128, the analyte sensor 112 may be mounted to the base plate 122, such as by at least one sensor fixation element 132, whereby the sensor fixation element 132 may seal the through hole 126.

[0192] The preassembled functional module 110 may further comprise at least one cover element or cover 134. The cover 134 may cover the electronics unit 120 and at least part of the analyte sensor 112. The cover 134 may be disposed on the base plate 122 on the upper side 128.

[0193] Further, the preassembled functional module 110 may comprise at least one plunger 136 which may be part of the insertion component 114 and/or which may be connected to the insertion component 114. The plunger 136 may be movable with respect to the base plate 122 and/or with respect to a housing 146 of the medical system 144 which will be described in further detail below. The base plate 122 may be applied to the skin site of the user when the analyte sensor 112 is inserted into the body tissue of the user, such as by the adhesive plaster 123. Thus, the base plate 122 may comprise the adhesive plaster 123 for fixing the preassembled functional module 110 to the skin site of the user.

[0194] The preassembled functional module 110 may have a rotational symmetry, for example, an axial rotational symmetry about an axis 137 such as a cylinder axis, as can be seen in FIG. 1b showing the preassembled functional module 110 in a perspective view. Even though the symmetry may simplify assembly, other geometries are possible as well.

[0195] In another embodiment, the preassembled functional module 110 does not have a rotational symmetry. This may allow easier manufacturing of the medical system 144 as the exact assembling of the preassembled functional module 110 with the housing 146 is easier.

[0196] The sterility cap 116 of the preassembled functional module 110 further comprises at least one sterility testing access 140, as will be described in further detail below. The sterility testing access 140 comprises at least one of a septum 142 and a multiple-step sealing 162. In the embodiment shown in FIGS. 1a-b, the sterility testing access 140 comprises the at least one septum 142. In other embodiments, such as shown in FIGS. 3a-d, the sterility testing access 140 may comprise the at least one multiple-step sealing 162, as will be explained in further detail below.

[0197] In FIG. 2, a first exemplary embodiment of a medical system 144 is shown in a cross-sectional view. The medical system 144 comprises a housing 146 which, for example, may be made of a plastic material and/or a metallic material. The housing 146 may be configured for providing protection for the enclosed parts, such as against mechanical and/or environmental influences, e.g., humidity.

[0198] The medical system 144 comprises the preassembled functional module 110, wherein the preassembled functional module 110 is received in the housing 146. The medical system 144 may comprise the embodiment of the preassembled functional module 110 shown in FIGS. 1a-b. For the description of the preassembled functional module 110, reference is therefore made to the description of FIGS. 1a-b.

[0199] The medical system 144 further comprises at least one removable protective cap 148. The removable protective cap 148 may fully or partially be made of a plastic material and/or a metallic material. The removable protective cap 148 may be connected to the housing 146 by a form-fit or a force-fit connection.

[0200] For example, a rim 147 of the removable protective cap 148 may be pushed over a rim 149 of the housing 146 or vice a versa. As another example, the removable protective cap 148 may be connected to the housing 146 via a threaded joint. The rims 147, 149 may form a tight connection or sealing. The removable protective cap 148 may be removed by the user by at least one of: pulling the removable protective cap 148 off the housing 146; turning the removable protective cap 148 off the housing 146.

[0201] Further, the removable protective cap 148 may comprise a funnel-shaped depression 150. Thus, the sterility cap 116, specifically the sterility testing access 140 of the sterility cap 116, may be accessible from an outer side 152 of the medical system 144. The sterility testing access 140 may specifically be accessible through the removable protective cap 148, more specifically through the removable protective cap 148 when the removable protective cap 148 is connected to the housing 146. In FIG. 2, the sterility testing access 140 exemplarily comprises the septum 142.

[0202] An access to the sterility cap 116 may be sealed by a removable seal 154, for example, by a removable liner 156. The removable liner 156 specifically may cover an opening 158 in the removable protective cap 148 through which the sterility cap 116 may be accessible after removing the removable seal 154. The opening 158 specifically may be an opening of the funnel-shaped depression 150.

[0203] Further, as can be seen in FIG. 2, the removable protective cap 148 may surround the sterility cap 116 within the opening 158. The opening 158 may be located within a distal surface of the removable protective cap 148 facing the skin of the user. The removable protective cap 148 may further be mechanically interlocked with the sterility cap 116 within the opening 158.

[0204] Further, the sterility cap 116 may be engaged with the removable protective cap 148, such that, when the removable protective cap 148 may be removed from the housing 146, the sterility cap 116 may be removed from preassembled functional module 110. For example, the sterility cap 116 may be mechanically interlocked with the removable protective cap 148. Thus, the mechanical interlock between the sterility cap 116 and the removable protective cap 148 may be accomplished by corresponding interlocking elements 159 of the sterility cap 116 and the removable protective cap 148, respectively, such as by one or more notches, hooks, protrusions, dents or the like, as the skilled person will recognize.

[0205] In order to prepare the medical system 144 for use, the user may remove the removable protective cap 148 from the housing 146, thereby removing the sterility cap 116 from the insertion component 114. The insertion component 114 may, thus, be revealed and the medical system 144 may be ready for use. Thereafter, the user may place a base part 138 of the housing 146 onto the skin site and actuate the insertion, as will be outlined in further detail below. As an example, the base part 138 may be or may comprise a distal edge or front rim 139, such as a circular front rim, for placement onto the skin site during insertion.

[0206] The sterility cap 116 may be arranged such that the sterility cap 116 may have at least one side in common with the removable protective cap 148. For example, the sterility testing access 140 may be located at the side which is in common with the removable protective cap 148. The side in common with the removable protective cap 148 specifically may be a distal side, facing the skin of the user.

[0207] The medical system 144 may further comprise at least one driving actuator 160. The driving actuator 160 may be configured for driving the insertion component 114 into a body tissue of the user. For example, the driving actuator 160 may engage with the plunger 136. The driving actuator 160 may be movable with respect to the base part 138 of the preassembled functional module 110. The driving actuator 160 may be movable in a forward direction, specifically in a direction towards the skin of a user. Thus, the driving actuator 160 may be configured for driving the insertion component 114 into the body tissue of the user. Further, the driving actuator 160 may be movable in a backward direction, specifically in a direction opposite to the forward direction, specifically after insertion. Thus, the driving actuator 160 may retract the insertion component 114 after the analyte sensor 112 has been inserted into the body tissue of the user, whereas the analyte sensor 112, at least with its inserted part, remains within the body tissue. The movement of the driving actuator 160, as an example, may be driven manually, such as by the user exerting a force onto the driving actuator 160. The movement into the backward direction specifically may be driven by a return spring 167.

[0208] In FIGS. 3a-d, a second exemplary embodiment of the medical system 144 is shown various views and states. The medical system 144 may, apart from the design of the sterility testing access 140, be widely identical to the first embodiment shown in FIG. 2 above, so reference may be made to the description of FIG. 2 above. FIGS. 3a and 3c show cross-sectional views of the second embodiment of the medical system 144, and FIGS. 3b and 3d show perspective views. Further, FIGS. 3a and 3b show the medical system 144 in a state in which a removable stopper 170 is attached to the sterility cap 116, which may be the normal state in which the medical system 144 may be stored, sold or used for insertion. FIGS. 3c and 3d show a second state of the medical system 144 in which the removable stopper 170 is removed and replaced by a fluidic adapter 172, for the purpose of sterility testing.

[0209] As outlined above, the medical system 144 in FIGS. 3a-d may widely correspond to the medical system 144 shown in FIG. 2, apart from the design of the sterility testing access 140. Thus, the sterility testing access 140 in the second embodiment shown in FIGS. 3a-d comprises a multiple-step sealing 162 which will be explained in further detail below.

[0210] Thus, in FIG. 4, an enlarged partial view of the medical system 144 of FIGS. 3a and 3b is shown in a cross-sectional view. In FIG. 5, an enlarged view of the medical system 144 of FIGS. 3c and 3d is shown in a cross-sectional view. In the following, the multiple-step sealing 162 will be explained with respect to these FIGS. 3a-d, 4 and 5 in conjunction.

[0211] The multiple-step sealing 162, as visible, e.g., in FIGS. 4 and 5, may comprise a plurality of circumferential sealing elements 164, such as two circumferential sealing elements 164. The circumferential sealing elements 164 may be disposed concentrically, specifically with respect to an axis of extension 141 of the sterility cap 116. The axis of extension 141 of the sterility cap 116 may be identical to the axis of rotational symmetry 137, such as the cylindrical axis. The cylindrical symmetry of the medical system 144 is shown in FIG. 3b, wherein the medical system 144 is shown in a perspective view.

[0212] Further, the sterility cap 116 may comprise a tubular sidewall 166. The tubular sidewall 166 may surround a sterility testing access opening 168 located at a distal end of the sterility cap 116. The sterility testing access opening 168 may be closed by the removable stopper 170. In FIGS. 3a-b and 4, the removable stopper 170 may seal the sterility testing access opening 168. The removable stopper 170 may be removed prior to sterility testing of the medical system 144. Thus, for sterility testing, the removable stopper 170 may be replaced by a fluidic adapter 172 which may be connected to the multiple-step sealing 162. This situation is shown in FIGS. 3c-d and 5. The fluidic adapter 172 may be attached to the sterility testing access 140. The fluidic adapter 172 may be configured for inserting and removing a rinsing liquid to the interior space 118 of the sterility cap 116, such as for flushing the interior space 118 with the rinsing liquid. A detailed view of the multiple-step sealing 162 is shown in FIGS. 4 and 5.

[0213] The multiple-step sealing 162 may be configured for sealing the sterility testing access 140 of the medical system 144. As outlined above, the multiple-step sealing 162 may comprise a plurality of circumferential sealing elements 164, specifically disposed within the sterility testing access opening 168. For example, the multiple-step sealing 162 may be a two-step sealing 174. The two-step sealing 174 may comprise a first-step sealing 176 and a second-step sealing 178. The two-step sealing 174 may also comprise circumferential sealing elements 164 which may be disposed concentrically, specifically with respect to an axis of extension 141 of the sterility cap 116.

[0214] Further, the two circumferential sealing elements 164 may comprise the tubular sidewall 166 surrounding the sterility testing access opening 168. The sterility testing access 140 of the sterility cap 116 may be disposed within the sterility testing access opening 168. The sterility testing access opening 168 may be closed by the removable stopper 170. Thus, the two-step sealing 174 may be configured for receiving the removable stopper 170 at a first-step sealing 176 of the multiple-step sealing 162. The removable stopper 170 may seal the sterility testing access 140 specifically at the first-step sealing 176.

[0215] In case the sterility of the medical system 144 shall be tested, the sterility testing access 140 may be accessible from the outer side 152 of the medical system 144 through the removable protective cap 148. For this purpose, the removable protective cap 148 may remain connected to the housing 146 of the medical system 144 during sterility testing. A removal of the removable seal 154 comprised by the removable protective cap 148 may reveal the sterility testing access 140. Thus, the removable stopper 170 sealing the sterility testing access 140 may be removed from the outer side 152 of the medical system 144.

[0216] In FIG. 5, an exemplary embodiment of the fluidic adapter 172 attached to the multiple-step sealing 162 of the medical system 144 is shown. Therein, the removable stopper 170 is removed from the sterility testing access 140. The stopper 170 may be removed prior to sterility testing. After the removal of the removable stopper 170, the fluidic adapter 172 may be attached to the sterility testing access 140. The fluidic adapter 172 may be configured for inserting the rinsing liquid into the interior space 118 of the sterility cap 116. The fluidic adapter 172 may be in contact with the second-step sealing 178 of the multiple-step sealing 162. Specifically, the second-step sealing 178 may have a smaller equivalent diameter than the first-step sealing 176. Thus, the fluidic adapter 172 may not contact the first-step sealing 176. The risk of a carryover of a contamination present on the first-step sealing 176 into the interior space 118 may be minimized.

[0217] In FIG. 6, an exemplary embodiment of a method of sterility testing of the medical system 144 is shown in a flowchart. The method of sterility testing 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 of sterility testing may comprise additional method steps that are not listed.

[0218] The medical system 144 specifically may be embodied according to any one of the embodiments disclosed above. At least, however, the medical system 144 comprises the preassembled functional module 110, wherein the preassembled functional module 110 comprises an analyte sensor 112 for detecting at least one analyte in a body fluid of a user. Further, the preassembled functional module 110 comprises at least one electronics unit 120 electrically connected to the analyte sensor 112 and an insertion component 114 for inserting the analyte sensor 112 into a body tissue of the user. The preassembled functional module 110 further comprises at least one sterility cap 116 at least partially surrounding the insertion component 114 and optionally at least a part of the analyte sensor 112.

[0219] The method of sterility testing 180 of the medical system 144 comprise the following steps: [0220] (denoted with reference number 182) inserting the rinsing liquid into an interior space 118 of the sterility cap 116 (step A); [0221] optionally: (denoted with reference number 184) removing the rinsing liquid from the interior space 118 of the sterility cap 116; and [0222] (denoted with reference number 186) microbial testing of the rinsing liquid (step B).

[0223] As outlined above, step 184 is an optional step. Thus, the microbial testing in step 186 may also be performed while at least part of the rinsing liquid still is in the interior space 118, e.g., while a reservoir of the rinsing liquid is still attached to the sterility cap 116.

[0224] In step A), the rinsing liquid may be applied to the interior space 118 through the sterility testing access 140 of the sterility cap 116. Thus, step A) may further comprise attaching the fluidic adapter 172 to the sterility testing access 140. For example, the fluidic adapter 172 may be a sterile cannula which is configured for piercing the septum 142 comprised by the sterility testing access 140. The rinsing liquid may be inserted into and removed from the interior space 118 through the cannula. As another example, the fluidic adapter 172 may be embodied by the fluidic adapter 172 shown in FIG. 5. Thus, the fluidic adapter 172 may be connected to the multiple-step sealing 162 of the sterility testing access 140. The fluidic adapter 172 may provide a fluidic connection from the outer side 152 of the medical system 144 to the interior space 118 of the sterility cap 116.

[0225] Alternatively, however, the embodiment of the medical system 144 of FIG. 2 may be used. In this embodiment, step A) may be performed by inserting and removing the rinsing liquid trough the septum 142. As an example, the septum 142 may be pierced by a needle or cannula of a syringe by which the rinsing liquid is inserted into the interior space 118 and by which the rinsing liquid may also be removed from the interior space 118.

[0226] The rinsing liquid may specifically be applied to the interior space 118 without contacting the housing 146 of the medical system 144. The rinsing liquid may further be inserted to the interior space 118 in such a way that a possible contamination of the sterile parts, such as the insertion component 114 and part of the analyte sensor 112, may be incorporated into the rinsing liquid.

[0227] Step B) of the method of sterility testing may comprise incubating the rinsing liquid. Thus, a possible contamination incorporated into the rinsing liquid may be determined. After incubating the rinsing liquid, the sterility testing 180 may comprise the result, whether the insertion component 114 and the analyte sensor 112 were sterile or not.

[0228] As outlined above, step A) of the method of sterility testing may comprise attaching the fluidic adapter 172 to the sterility testing access 140 and inserting at least a part of the rinsing liquid into the interior space 118 of the sterility cap 116. In particular, at least a part of the rinsing liquid may remain outside the interior space 118 of the sterility cap 116, e.g., in a reservoir, but may fluidically be in contact with the rinsing liquid inside the interior space 118. In this state, step B) of the method may be performed. Thus, the rinsing liquid may be incubated with the fluidic adapter 172 attached to the sterility testing access 140, wherein the rinsing liquid outside the interior space 118 may be in fluidic contact with the sterile parts inside the interior space 118 of the sterility cap 116.

[0229] FIG. 7 shows a flowchart of an exemplary embodiment of a method of providing the medical system 144. The medical system 144 specifically may be embodied according to any one of the embodiments disclosed above. Thus, for optional details, reference may be made to the description of these embodiments. The method of providing the medical system 144 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 of providing the medical system 144 may comprise additional method steps that are not listed.

[0230] The method of providing the medical system 144 comprises the following steps: [0231] I. (denoted with reference number 188) assembling a part 195 of the preassembled functional module 110, the part 195 of the preassembled functional module 110 comprising the analyte sensor 112 and the insertion component 114 as well as the sterility cap 116 at least partially surrounding the insertion component 114; [0232] II. (denoted with reference number 190) sterilizing the part 195 of the preassembled functional module 110, specifically by using one or more of e-beam or gamma sterilization; [0233] III. (denoted with reference number 192) assembling the preassembled functional module 110, the assembling comprising electrically connecting the electronics unit 120 to the analyte sensor 112; and [0234] IV. (denoted with reference number 194) assembling the medical system 144, the assembling comprising receiving the preassembled functional module 110 in the housing 146 and connecting the removable protective cap 148 to the housing 146.

[0235] Step I. of the method of providing the medical system 144 may refer to an assembly of a part of the medical system 144 which comprises at least some of the components to be sterilized. The part 195 assembled in step I. may form a subgroup of the preassembled functional module 110. In FIGS. 8a and 8b, an exemplary embodiment of this part 195 or subgroup of the preassembled functional module 110 is shown in a cross-sectional view (FIG. 8a) and in a perspective view (FIG. 8b). Therein, the preassembled functional module 110 corresponds to the embodiment of FIGS. 1a-b and 2. As the skilled person will recognize, however, the subgroup may also be embodied, within the scope of this disclosure, in other ways, such as according to the embodiment shown in FIGS. 3a-d, 4 and 5.

[0236] The part 195 or subgroup, as shown in FIGS. 8a-b, comprises at least some of the sterile parts of the medical system 144. The sterile parts may comprise at least the analyte sensor 112, the insertion component 114 and/or the sterility cap 116. Further, the subgroup may comprise the sensor fixation element 132 and/or the base plate 122. As can be seen in FIG. 8b, the base plate 122, as an example, may comprise one or more structural elements 198, such as for mounting the electronic unit 120, for electrically contacting the analyte sensor 112, for receiving an electrical energy storage device or the like. The subgroup may be assembled under clean conditions, such as in a clean room facility or the like.

[0237] After performing step I., i.e., after assembling part 195, part 195 may be subjected to the sterilization in step II. For this purpose, as an example, the subgroup may be transferred to a sterilization unit, such as an X-ray sterilizer, a gamma sterilizer, an e-beam sterilizer or the like. At this stage, preferably, no components which are prone to electronic damages by the sterilization process are present in the subgroup, such as the electronics unit 120.

[0238] After performing step II., the part 195, also referred to as the subgroup, is a sterilized part or sterilized subgroup. Thus, specifically, the interior space 118 is in a sterilized condition, including the parts received therein, such as the insertion component 114 and the part of the analyte sensor 112 received therein.

[0239] The sterilized part 195 may then undergo further processing, wherein, however, the sterilized state of at least the interior space 118 and the parts received therein remains unchanged.

[0240] Thus, in step III., the electronics unit 120 may be attached to the part 195. Further, the cover 134 may be mounted, thereby closing the preassembled functional module 110. Further, the adhesive plaster 123 may be applied to the base plate 122.

[0241] In step IV., the preassembled functional module 110 may be combined with other components of the medical system 144. Thus, the preassembled functional module 110 may be inserted into the housing 146. Further, the removable protective cap 148 may be attached to the housing 146, and the removable seal 154 may be applied.

[0242] Thus, the method of providing the medical system 144 may comprise an assembly process wherein sterile and non-sterile part may be processed.

[0243] The method of providing the medical system 144 may further comprise: [0244] V. (denoted by reference number 196) storing the medical system 144.

[0245] After storing the medical system 144, the method of providing the medical system 144 may further comprise: [0246] VI. (denoted by reference number 180) sterility testing of the medical system 144 by using the method of sterility testing of a medical system 144.

[0247] The sterility of the medical system 144 may be tested by performing step VI. Step VI. may be performed on few selected medical systems 144. The medical systems 144 subjected to sterility testing 180 may be selected on a random basis, specifically in such a way that the sterility testing 180 of the few selected medical systems 144 may allow for verifying the sterility of all assembled medical systems 144. For example, a percentage of sterility tested medical systems 144 to assembled medical systems 144 may be less than 1%, e.g., 0.1% or even less.

[0248] 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.

LIST OF REFERENCE NUMBERS

[0249] 110 preassembled functional module [0250] 112 analyte sensor [0251] 114 insertion component [0252] 116 sterility cap [0253] 118 interior space [0254] 120 electronics unit [0255] 122 base plate [0256] 123 adhesive plaster [0257] 124 predetermined breaking point [0258] 126 through hole [0259] 128 upper side [0260] 130 lower side [0261] 132 sensor fixation element [0262] 134 cover [0263] 136 plunger [0264] 137 symmetry axis [0265] 138 base part [0266] 139 front rim [0267] 140 sterility testing access [0268] 141 axis of extension [0269] 142 septum [0270] 144 medical system [0271] 146 housing [0272] 147 rim of the removable protective cap [0273] 148 removable protective cap [0274] 149 rim of the housing [0275] 150 funnel-shaped depression [0276] 152 outer side [0277] 154 removable seal [0278] 156 removable liner [0279] 158 opening [0280] 159 interlocking element [0281] 160 driving actuator [0282] 162 multiple-step sealing [0283] 164 circumferential sealing elements [0284] 166 tubular sidewall [0285] 167 return spring [0286] 168 sterility testing access opening [0287] 170 removable stopper [0288] 172 fluidic adapter [0289] 174 two-step sealing [0290] 176 first-step sealing [0291] 178 second-step sealing [0292] 180 sterility testing [0293] 182 inserting a rinsing liquid [0294] 184 removing a rinsing liquid [0295] 186 microbial testing of a rinsing liquid [0296] 188 assembling a part of a preassembled functional module [0297] 190 sterilizing a part of a preassembled functional module [0298] 192 assembling a preassembled functional module [0299] 194 assembling a medical system [0300] 195 part of the preassembled functional module [0301] 196 storing a medical system [0302] 198 structural elements