INSERTION SYSTEM AND METHOD FOR INSERTING A MEDICAL DEVICE

Abstract

An insertion system comprises a medical device and an insertion device for inserting the medical device into a body tissue of a user, the insertion device comprising: an insertion component-configured for inserting the medical device into the body tissue; an insertion component retractor; a cap; a guide sleeve and an insertion sleeve guided therein; a locking sleeve in the insertion sleeve; and an elastic member positioned between the locking sleeve and the insertion component retractor; wherein, for inserting the medical device, the cap, the insertion component retractor, the locking sleeve and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position, wherein the insertion device is separable from the medical device, wherein the insertion system is separation of the insertion device from the medical device releasing a movement of the locking sleeve from its proximal position to a further proximal position.

Claims

1. An insertion system, the insertion system comprising a medical device and an insertion device for inserting the medical device into a body tissue of a user, the insertion device comprising: i) an insertion component configured for inserting the medical device into the body tissue; ii) an insertion component retractor; iii) a cap; iv) a guide sleeve and an insertion sleeve guided therein; v) a locking sleeve positioned in the insertion sleeve; and vi) an elastic member positioned between the locking sleeve and the insertion component retractor; wherein, for inserting the medical device, the cap, the insertion component retractor, the locking sleeve and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position, wherein the insertion device is separable from the medical device, wherein the insertion system is configured such that a separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position to a further proximal position, and wherein the movement of the locking sleeve from its proximal position to the further proximal position releases a movement of the insertion component retractor from its proximal position to a retracted position.

2. The insertion system according to claim 1, wherein the movement of the locking sleeve from its proximal position to the further proximal position is a helical movement of the locking sleeve.

3. The insertion system according to claim 1, wherein the locking sleeve comprises at least one first locking sleeve slot, wherein the insertion component retractor comprises at least one wing and wherein the insertion sleeve comprises at least one insertion sleeve slot.

4. The insertion system according to claim 3, wherein for inserting the medical device the wing is configured for protruding through the first locking sleeve slot and for engaging the insertion sleeve slot, thereby blocking a movement of the insertion component retractor.

5. The insertion system according to claim 3, wherein the first locking sleeve slot is z-shaped.

6. The insertion system according to claim 3, wherein the first locking sleeve slot has at least one inclined surface configured for blocking movement of the insertion component retractor.

7. The insertion system according to claim 3, wherein a rotational movement of the locking sleeve within the insertion sleeve causes at least partial alignment of the first locking sleeve slot and the insertion sleeve slot such that the wing of the insertion component retractor is movable, wherein the elastic member is configured for moving the insertion component retractor to its retracted position, thereby the insertion component is retracted into the insertion device.

8. The insertion system according to claim 7, wherein the locking sleeve comprises at least one second locking sleeve slot, wherein the insertion sleeve comprises at least one inward protrusion, wherein the second locking sleeve slot is configured for interacting with the inward protrusion, wherein a rotational movement of the locking sleeve within the insertion sleeve is blocked as long as a linear movement of the locking sleeve is blocked.

9. The insertion system according to claim 1, wherein the elastic member comprises at least one spring.

10. The insertion system according to claim 9, wherein the spring is pretensioned.

11. The insertion system according to claim 1, wherein the medical device comprises a housing and the insertion sleeve comprises holding elements, wherein the housing is held by the holding elements, wherein the housing is configured for blocking movement of the locking sleeve in direction of the housing while the housing is held by the holding elements.

12. The insertion system according to claim 1, wherein the medical device comprises at least one device selected from the group consisting of an analyte sensor for detecting at least one analyte in a body fluid of a user and an infusion cannula.

13. A method for inserting a medical device using the insertion system according to claim 1, the method comprising the steps: a) applying the insertion device to a user's skin, b) applying a force to the cap of the insertion device so that the cap moves from a distal position to a proximal position, c) removing the insertion device from the user's skin, thereby separating the insertion device from the medical device, wherein the separation releases a movement of the locking sleeve from its proximal position to a further proximal position.

Description

SHORT DESCRIPTION OF THE FIGURES

[0135] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0136] In the Figures:

[0137] FIG. 1 shows an exemplary embodiment of an insertion system according to the present invention in a longitudinal-sectional view;

[0138] FIG. 2 shows an exemplary embodiment of an insertion component retractor in a perspective view;

[0139] FIG. 3 shows an exemplary embodiment of a cap in a perspective view;

[0140] FIG. 4 shows an exemplary embodiment of a guide sleeve in a perspective view;

[0141] FIG. 5 shows an exemplary embodiment of an insertion sleeve in a perspective view;

[0142] FIG. 6 shows an exemplary embodiment of a locking sleeve in a perspective view; and

[0143] FIGS. 7A to 7E show an exemplary embodiment of an insertion system according to the present invention in different longitudinal-sectional views.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0144] FIG. 1 shows an exemplary embodiment of an insertion system 110. The insertion system 110 comprises a medical device 112 and an insertion device 113 for inserting the medical device 112 into a body tissue of a user according to the present invention. In FIG. 1, the insertion system 110 is shown in a longitudinal-sectional view, wherein the longitudinal-sectional view passes through a median plane of the insertion system 110. Further, FIG. 1 shows the insertion system 110 prior to insertion of the medical device 112.

[0145] The medical device 112 may be an arbitrary element or article being configured for use in the field of medical technology, specifically in the field of medical analytics or medical diagnostics. The medical device 112 may be configured for performing at least one medical function and/or for being used in at least one medical process, such as one or more of a therapeutic process, a diagnostic process or another medical process.

[0146] For example, the medical device 112 may be or may comprise at least one analyte sensor 114 for detecting at least one analyte in a body fluid of a user, such as in a body fluid contained in a body tissue of the user. The analyte sensor 114 may be configured for being used in qualitatively and/or quantitatively detecting the at least one analyte. The analyte may be a chemical and/or biological substance which takes part in the metabolism of the body of the user. Specifically, the analyte may be a metabolite or a combination of two or more metabolites. As an example, the analyte may be selected from the group consisting of: glucose, lactate, triglycerides, cholesterol. Still, other analytes or combinations of two or more analytes may be detected. The body tissue specifically may be or may comprise fatty tissue and/or interstitium. Other types of body tissue, however, are feasible.

[0147] The analyte sensor 114 may be a sensor which is capable of qualitatively or quantitatively detecting the presence and/or the concentration of the at least one analyte. For example, the analyte sensor 114 may be an electrochemical analyte sensor. The analyte sensor 114 may comprise at least two electrodes. Specifically, the analyte sensor 114 may comprise at least one two-electrode sensor.

[0148] The two-electrode sensor may comprise precisely two electrodes, such as a working electrode and at least one further electrode such as a counter electrode, in particular a working electrode and a combined counter/reference electrode. The working electrode may comprise a working electrode pad and, optionally, at least one test chemical disposed thereon. The counter electrode may comprise a counter electrode pad. Additionally and optionally, one or more redox materials may be disposed thereon. The analyte sensor 114 may further comprise one or more leads for electrically contacting the electrodes. The leads may, during insertion or at a later point in time, be connected to an electronic component 116. Preferably, the leads are already connected to the electronics component 116 before insertion of the analyte sensor 114.

[0149] Specifically, the analyte sensor 114 may be a needle-shaped or a strip-shaped analyte sensor having a flexible substrate and the electrodes disposed thereon. As an example, the analyte sensor 114 may have a total length of 5 mm to 50 mm, specifically a total length of 7 mm to 30 mm. The analyte sensor 114 may further comprise a biocompatible cover, such as a biocompatible membrane which fully or partially covers the analyte sensor 114 and which prevents the test chemical from migrating into the body tissue and which allows for a diffusion of the body fluid and/or the analyte to the electrodes. Other embodiments of electrochemical analyte sensors 114, such as three-electrode sensors, may be feasible. For example, the three-electrode sensor may comprise, in addition to the working electrode and the counter electrode, a reference electrode.

[0150] In another embodiment, the analyte sensor 114 may be an optical analyte sensor. For example, the analyte sensor 114 may comprise a flexible light guide with glucose sensitive coating at its end and/or a tube like carrier with functional elements at inner or outer walls. Other embodiments of the analyte sensor 114 may be possible too. For potential embodiments of analyte sensors 114, reference may be made to the above-mentioned prior art documents.

[0151] In another embodiment not depicted here, for example, the medical device 112 may be or may comprise at least one infusion cannula. The infusion cannula may be or may comprise a hollow tube configured for delivering and/or infusing a medication, in particular insulin, into the body tissue of the user, in particular for delivering and/or infusing insulin into the body tissue of the user.

[0152] The user may be a person using the insertion system 110. The user may be a person intending to monitor an analyte value, such as a glucose value in the person's body tissue and/or to deliver medication, such as insulin into the person's body tissue. For example, the user may be a patient suffering from a disease, such as diabetes.

[0153] The inserting of the medical device 112 may comprise one or more of transcutaneously or subcutaneously implanting and/or positioning the medical device 112 into the body tissue of the user. The medical device 112, such as the analyte sensor 114, may fully or partially be inserted into the body tissue. The insertion of the medical device 112 may be performed by using the insertion device 113. The insertion device 113 may be configured for inserting the medical device 112 into the body tissue. The insertion device 113 may be configured for transcutaneously or subcutaneously inserting the medical device 112 into the body tissue, such as by performing an incision or a puncture in a skin of the user and by transferring the medical device 112 fully or partially into the body tissue. After insertion, the medical device 112 or at least a part of the medical device 112 may remain in the body tissue of the user for a predetermined period of time, such as for several hours, specifically for one or more days, more specifically for up to one week, even more specifically for up to two weeks or even more. The medical device 112 may be configured for continuously monitoring and/or detecting the analyte in the body fluid of the user.

[0154] The insertion device 113 comprises an insertion component 118, an insertion component retractor 120, a cap 122, a guide sleeve 124, a locking sleeve 126, an insertion sleeve 128 and an elastic member 130.

[0155] The insertion component 118 is configured for inserting the medical device 112 into the body tissue. The insertion component 118 may be insertable at least partially into the body tissue, particularly in order to deliver or to transfer a further element. The insertion component 118 may be configured for supporting the insertion of the medical device 112. The insertion component 118 may comprise a tip or a sharp end for inserting the medical device 112 into the body tissue. The insertion component 118 may be or may comprise an insertion cannula or an insertion needle.

[0156] As outlined above, after insertion, the medical device 112 may remain in the body tissue of the user. The insertion component 118, however, may be retracted from the body tissue of the user into the insertion device 113 after inserting the medical device 112. For retracting the insertion component 118, the insertion device 113 may comprise the insertion component retractor 120. An engagement between the insertion component retractor 120 and the insertion component 118 may be loose, specifically not fastened. The engagement between the insertion component retractor 120 and the insertion component 118 may be established during a production process.

[0157] FIG. 2 shows an exemplary embodiment of an insertion component retractor 120 in a perspective view.

[0158] The insertion component retractor 120 may comprise at least one finger, gripper, hook, pincer or the like configured for retracting the insertion component 118. For example, the insertion component retractor 120 may comprise two or more fingers, grippers, hooks or pincers arranged symmetrically around the insertion component 118 which is exemplarily depicted in FIG. 1. The finger, gripper, hook, pincer or the like may be arranged at a proximal end 134 of the insertion component retractor 120, wherein, when the insertion system 110 is in use, the proximal end 134 of the insertion component retractor 120 may point towards the body tissue of the user (not shown). For example, in the exemplary embodiment shown in FIG. 2, the insertion component retractor 120 may comprise three grippers 132. The grippers 132 may be arranged at the proximal end 134 of the insertion component retractor 120. The grippers 132 may be arranged symmetrically around the insertion component 118. For example, the insertion system 110 may comprise at least one plunger 119 connected to the insertion component 118. The plunger 119 is illustrated in FIG. 1. The insertion component retractor 120 may be connected to the plunger 119 and/or may be configured for grabbing the plunger 119 to drive the insertion component 118 to perform the insertion movement and/or the retraction movement. Specifically, the grippers 132 may be configured for retracting the insertion component 118, specifically by being connected and/or by grabbing the plunger 119 as will be outlined in further detail below.

[0159] The insertion component retractor 120 may further comprise at least one wing 136. The wing 136 may be at least one element protruding outwards the insertion component retractor 120, in particular perpendicular to an insertion direction 138. The insertion component retractor 120 may form a cylindrical body. The cylindrical body may be disposed concentrically with respect to an axis of extension 139. The wing 136 may protrude outwards from a lateral surface of the cylindrical body. Specifically, the wing 136 may protrude perpendicular to the insertion direction 138, which may be essentially parallel with the axis of extension 139. In the embodiment of FIG. 2, the insertion component retractor 120 may comprise at least two wings 136. The two wings 136 may be arranged opposite to each other at an outside of the insertion component retractor 120. The wing 136 may be configured for interacting with other components of the insertion device 113 which will be described in further detail below.

[0160] FIG. 3 shows an exemplary embodiment of the cap 122 in a perspective view. The cap 122 may surround and/or may enclose fully or partially one or more further components, such as the insertion component retractor 120, the guide sleeve 124, the insertion sleeve 128, the locking sleeve 126, the elastic member 130 and/or the insertion component 118 such as illustrated in FIG. 1. For example, as illustrated in FIG. 1, the cap 122 may fully surround the insertion component retractor 120 and may partially surround the locking sleeve 126, the insertion sleeve 128 and the elastic member 130. The cap 122 may also at least partially surround the guide sleeve 124 and, thus, may fully cover the guide sleeve 124 except for a proximal end 142 of the guide sleeve 124. As shown in FIG. 1, a proximal side 144 of the insertion device 113 may be at least partially uncovered by the cap 122 allowing contacting the user's skin with the guide sleeve 124 and movement of the insertion component 118 outside of the insertion device 113. The proximal side 144 may be the side of the insertion device 113 providing a contact area or region with the user's skin. A distal side 148 may be a side of the insertion device 113 opposite of the proximal side 144. The cap 122 may be or may comprise a rigid cap, such as a rigid cap made of one or more of a plastic material, a metallic material or a cardboard material.

[0161] The cap 122 specifically may be essentially rotationally symmetric, e.g. by having an axial rotational symmetry about an axis such as a cylinder axis or the axis of extension 139. The cap 122 may be designed as a cylinder, a hemisphere or as a dome. However, also other embodiments may be feasible. The cap 122 may have a shape which is adapted to a shape of the medical device 112. The cap 122 may comprise an inner structure 150 which may not be rotationally symmetric. An outer shape of the cap 122 may also be asymmetrical, e.g. may be shaped ergonomically to be held by a user's hand. The inner structure 150 of the cap 122 may be cylindrical or prismatic corresponding a structure of the insertion sleeve 128. The cap 122 may further comprise at least one latching element 152, specifically at the inner structure 150 of the cap 122. The latching element 152 may be configured for holding components of the insertion device 113 together. Specifically, the latching element 152 may interlock the cap 122 with at least one of the other components, such as the insertion sleeve 128.

[0162] FIG. 4 shows an exemplary embodiment of the guide sleeve 124 in a perspective view. The guide sleeve 124 may be essentially rotationally symmetric, specifically in accordance with the symmetry of the cap 122, in particular of the inner structure of the cap 122. For example, in case the cap 122 may have an axial rotational symmetry about an axis such as a cylinder axis or the axis of extension 139, the guide sleeve 124 may have a similar axial rotational symmetry. However, also other embodiments may be feasible. Specifically, the guide sleeve 124 may have a shape which is adapted to a shape of the medical device 112.

[0163] The guide sleeve 124 may be movable with respect to the cap 122. For example, when using the insertion device 113, the guide sleeve 124 may be configured for sliding into the cap 122. The guide sleeve 124, in particular the proximal end 142 of the guide sleeve 124, may be in contact with the user's skin when the insertion device 113 is used.

[0164] The guide sleeve 124 may comprise at least one inner guide sleeve latching element 154. The inner guide sleeve latching element 154 of the guide sleeve 124 may be arranged on an inner side 156 of the guide sleeve 124. Specifically, the inner guide sleeve latching element 154 may be arranged such that it faces the components enclosed by the guide sleeve 124, specifically the insertion sleeve 128. The inner guide sleeve latching element 154 may be configured for holding the insertion sleeve 128. The inner guide sleeve latching element 154 may interlock the guide sleeve 124 with the insertion sleeve 128. Specifically, the guide sleeve 124 may comprise at least two first inner guide sleeve latching elements 157, specifically at least two grippers 158. The grippers 158 may be arranged opposite to each other. Further, the grippers 158 may be inclined inwards. Further, the guide sleeve 124 may comprise at least two second inner guide sleeve latching elements 160. The second inner guide sleeve latching elements 160 may be arranged opposite to each other. The second inner guide sleeve latching elements 160 may respectively comprise one or more guide rails 162, specifically two guide rails 162. The guide rails 162 may extend essentially parallel to the axis of extension 139 of the guide sleeve 124. Further, the second inner guide sleeve latching elements 160 may respectively comprise at least one protrusion 164 which extends transverse, specifically perpendicular, to the guide rails 162. The protrusion 164 may be arranged between the two guide rails 162. Further, the protrusion 164 may be arranged in a distance to a first end 166 of the guide rails 162 and in a distance to a second end 168 of the guide rails 162. The interaction of the inner guide sleeve latching elements 154 with the insertion sleeve 128 may be described in further detail below.

[0165] As shown in FIG. 1, the insertion sleeve 128 itself may be enclosed fully or partially by the guide sleeve 124 and the cap 122 of the insertion device 113.

[0166] FIG. 5 shows an exemplary embodiment of the insertion sleeve 128 in a perspective view. The insertion sleeve 128 may be essentially rotationally symmetric, specifically in accordance with the symmetry of the cap 122 and the guide sleeve 124. For example, the cap 122 and the guide sleeve 124 may have an axial rotational symmetry about an axis such as a cylinder axis or the axis of extension 139, the insertion sleeve 128 may have a similar axial rotational symmetry.

[0167] The insertion sleeve 128 may be configured for receiving the locking sleeve 126, as illustrated in FIG. 1. For example, the insertion sleeve 128 may comprise a rotational symmetric hollow center 176. The locking sleeve 126 may be received at least partially within the rotational symmetric hollow center 176. The rotational symmetric hollow center 176 may specifically be open to a distal end 178 of the insertion sleeve 128 and to a proximal end 180 of the insertion sleeve 128. The rotational symmetric hollow center 176 may further be configured for receiving the medical device 112 at least partially. The medical device 112 may be arranged at the proximal end 180 of the insertion sleeve 128, as illustrated in FIG. 1.

[0168] Specifically, the insertion sleeve 128 may comprise at least one first cylindrically shaped component 182 and at least one second cylindrically shaped component 184. The first cylindrically shaped component 182 may have a first diameter d.sub.1 and the second cylindrically shaped component 184 may have a second diameter d.sub.2. The first diameter d.sub.1 may be larger than the second diameter d.sub.2. The second cylindrically shaped component 184 may be received at least partially in the first cylindrically shaped component 182. Specifically, the second cylindrically shaped component 184 and the first cylindrically shaped component 182 may be arranged essentially concentrically. The second cylindrically shaped component 184 may be configured for interacting with the locking sleeve 126. The first cylindrically shaped component 182 may be configured for attachment to the guide sleeve 124. The first cylindrically shaped component 182 may specifically be configured for stabilizing guide receptacles 220 which will further be described below in more detail.

[0169] Further, the insertion sleeve 128 may comprise at least one insertion sleeve slot 186. The insertion sleeve slot 186 may exemplarily be a trench cut 188 in the insertion sleeve 128 such that the insertion sleeve slot 186 may only partially cut into the insertion sleeve 128. Specifically, the insertion sleeve slot 186 may be part of the second cylindrically shaped component 184. Thus, exemplarily, the insertion sleeve slot 186 may be a trench cut 188 in the second cylindrically shaped component 184.

[0170] The insertion sleeve slot 186 of the insertion sleeve 128 may extend essentially parallel to the axis of extension 139 of the insertion sleeve 128. The insertion sleeve slot 186 may specifically be a straight slot 200. In the embodiment of FIG. 5, the insertion sleeve 128 may comprise at least two insertion sleeve slots 186. The two insertion sleeve slots 186 may be arranged opposite to each other. The insertion sleeve slot 186 may be configured for interacting with the wings 136 of the insertion component retractor 120 which will be described in further detail below.

[0171] Further, the insertion sleeve 128 may comprise at least one inward protrusion 202. The inward protrusion 202 may protrude from the insertion sleeve 128 into an interior of the insertion sleeve 128. Specifically, the inward protrusion 202 may be arranged such that it faces the components enclosed by the insertion sleeve 128, specifically the locking sleeve 126. The inward protrusion 202 may be configured for interacting with components of the locking sleeve 126 which will further be discussed below in more detail. Specifically, the insertion sleeve 128 may comprise two inward protrusions 202 which may be arranged opposite to each other in the interior of the insertion sleeve 128. Specifically, the inward protrusion 202 may be part of the second cylindrically shaped component 184.

[0172] Further, the insertion sleeve 128 may comprise at least one support surface 204. Specifically, the insertion sleeve 128 may comprise a dead stop 206. The dead stop 206 may specifically be ring-shaped. The dead stop 206 may specifically be formed as a protrusion protruding from the insertion sleeve 128 into an interior of the insertion sleeve 128. The dead stop 206 may have the support surface 204. The dead stop 206 may specifically be configured for preventing the locking sleeve 126 from dropping out of the insertion sleeve 128. Further, the dead stop 206 may form a bottom of the second cylindrically shaped component 184 and may provide a cutout for a proximal end of the locking sleeve 126. When the locking sleeve 126 is in the distal position, the locking sleeve 126 may be arranged in a distance to the support surface 204. This is illustrated in FIG. 1. When the locking sleeve 126 is in the proximal position, the locking sleeve 126 may be in direct contact with the support surface 204. The support surface 204 may be configured for blocking the locking sleeve 126. Specifically, the support surface 204 may be configured for preventing a further movement of the locking sleeve 126 in the insertion direction 138. Thus, in the further proximal position, the locking sleeve 126 may rest on the dead stop 206. The inward protrusion 202 may be arranged on the resting element 206. Specifically, the inward protrusion 202 and the dead stop 206 may be formed as one piece. Specifically, the dead stop 206 may be part of the second cylindrically shaped component 184. The dead stop 206 may be arranged at a lower end 208 of the second cylindrically shaped component 184 as illustrated in FIG. 1.

[0173] Further, the insertion sleeve 128 may comprise at least one insertion sleeve latching element 210. The insertion sleeve latching element 210 may be arranged on an outer side 212 of the insertion sleeve 128. Specifically, the insertion sleeve latching element 210 may be arranged such that it faces the guide sleeve 124. The insertion sleeve latching element 210 may be configured for interacting with the inner guide sleeve latching element 154 of the guide sleeve as described above. Specifically, the insertion sleeve 128 may comprise at least one insertion sleeve latching element 214. The insertion sleeve latching element 214 may be configured for interacting with the first inner guide sleeve latching element 157, specifically with the gripper 158 which is as described above. Specifically, the insertion sleeve 128 may comprise at least two insertion sleeve latching elements 214. The at least two insertion sleeve latching elements 214 may be arranged opposite to each other. The insertion sleeve latching element 214 may specifically comprise at least one resting surface 218 on which the first inner guide sleeve latching element 157, specifically the gripper 158, may rest.

[0174] Further, the insertion sleeve 128 may comprise at least two insertion sleeve guide rails 216. The second insertion sleeve guide rails 216 may be configured for guiding a linear movement of the insertion sleeve 128 in the guide sleeve 124. The insertion sleeve guide rails 216 may be arranged opposite to each other. The insertion sleeve guide rails 216 may respectively comprise one or more guide receptacles 220. The guide receptacles 220 may extend essentially parallel to the axis of extension 139 of the insertion sleeve 128. Further, the insertion sleeve guide rails 216 may respectively comprise at least one receptacle 222 which extends transverse, specifically perpendicular, to the guide receptacles 220. The receptacle 222 may be arranged between the guide receptacles 220. Further, the receptacle 222 may be arranged in a distance to a first end 224 of the guide receptacles 220 and in a distance to a second end 226 of the guide receptacles 220.

[0175] When the insertion sleeve 128 moves relative to the guide sleeve 124 from the distal position to the proximal position, the insertion sleeve 128 may be slid at least partially into the guide sleeve 124. Thereby, the guide rails 162 of the second inner guide sleeve latching elements 160 of the guide sleeve 124 may slide in the guide receptacles 220 of the insertion sleeve guide rails 216. A sliding movement may be stopped when the protrusion 164 of the second inner guide sleeve latching elements 160 of the guide sleeve 124 is received in the receptacle 222 of the insertion sleeve guide rails 216 of the insertion sleeve 128. Further, in an assembled state of the guide sleeve 124 and the insertion sleeve 128 the grippers 158 may rest on the resting surface 218 of the insertion sleeve latching element 214 of the insertion sleeve 128.

[0176] Further, the insertion sleeve 128 may comprise one or more holding elements 228. As illustrated in FIG. 1, an inner surface 230 of the insertion sleeve 128 may be formed as holding element 228. The inner surface 230 may be configured for engaging with a housing 232 of the medical device 112, specifically of a surface 234 of the housing 232 of the medical device 112.

[0177] FIG. 6 shows an exemplary embodiment of a locking sleeve 126 in a perspective view. The locking sleeve 126 may fully or partially enclose the insertion component retractor 120 as illustrated in FIG. 1. The locking sleeve 126 may be partially enclosed by the insertion sleeve 128 and/or the cap 122 as illustrated in FIG. 1. The locking sleeve 126 may be essentially rotationally symmetric, specifically in accordance with the symmetry of the insertion sleeve 128.

[0178] The locking sleeve 126 may comprise at least one receptacle 234. The receptacle 234 may be arranged at a distal end 238 of the locking sleeve. The receptacle 234 may have at least one opening 236. The insertion component 118 and/or the insertion component retractor 120 may extend at least partially through the opening 236.

[0179] The locking sleeve 126 may comprise the at least one first locking sleeve slot 240. Further, the locking sleeve 126 may comprise at least one second locking sleeve slot 242. The first locking sleeve slot 240 and/or the second locking sleeve slot 242 of the locking sleeve 126 may extend essentially parallel to the axis of extension 139 of the locking sleeve 126. The first locking sleeve slot 240 and/or the second locking sleeve slot 242 may comprise at least one edge 244 and, thus, may diverge from the axis of extension 139 at the location of the edge 244. The edge 244 may be a z-shaped edge. Further, the first locking sleeve 240 slot and/or the second locking sleeve slot 242 may comprise at least one straight section 246.

[0180] FIGS. 7A to 7E show an exemplary embodiment of an insertion system according to the present invention in different longitudinal-sectional views and during different stages of the insertion method. The embodiments according to FIGS. 7A to 7E correspond at least in large parts to the embodiment according to FIG. 1. Further, the components of the insertion system 110 according to FIGS. 7A to 7E may correspond at least in large parts to the components as illustrated in FIGS. 2 to 6. Thus, reference to FIGS. 1 to 6 above is made.

[0181] As illustrated in FIG. 7A, the locking sleeve 126 may be arranged in the insertion sleeve 128. Further, the insertion component retractor 120 may be arranged in the locking sleeve 126. The wings 136 of the insertion component retractor 120 may protrude through the first locking sleeve slot 240 of the locking sleeve 126. The first locking sleeve slot 240 may be z-shaped. Specifically, the first locking sleeve slot 240 may have the edge 244. The edge 244 may have an inclined surface 250. Specifically, the wing 136 may have an inclined wing surface 248. The inclined wing surface 248 of the wing 136 may rest on the inclined surface 250 of the edge 244 of the first locking sleeve slot 240.

[0182] Further, as illustrated in FIG. 7B, the wing 136 may engage with the insertion sleeve slot 186 of the insertion sleeve 128. Thus, a rotation of the insertion component retractor 120 may be blocked. Since the elastic member 130, which may specifically be embodied as a spring 252, rests with its lower end 254 on a bottom 258 of the locking sleeve 128 (see FIG. 1) and stems its upper end 256 under the insertion element retractor 120, the insertion element retractor 120 and the locking sleeve 126 may be loaded and intend to rotate relative to each other. However, the wing 136 may be configured to block the movement of the insertion component retractor 120.

[0183] Further, as illustrated in FIG. 7C, the locking sleeve 126 may comprise the at least one second locking sleeve slot 242. Further, as also outlined above, the insertion sleeve 128 may comprise the at least one inward protrusion 202. The second locking sleeve slot 242 may be configured for interacting with the inward protrusion 202. A rotational movement of the locking sleeve 126 within the insertion sleeve 128 may be blocked as long as a linear movement of the locking sleeve 126 is blocked.

[0184] The movement of the locking sleeve 126 may be blocked by the housing 232 of the medical device 112. The elastic member 130 may be pre-tensioned and the insertion system 110 as illustrated in FIG. 7C may be in a cocked mode.

[0185] In FIG. 7D, the insertion system 110 is shown in an inserted state. Thus, the medical device 112, the cap 122, the insertion component retractor 120, the locking sleeve 126 and the insertion sleeve 128 are moved relative to the guide sleeve 124 from the distal position, as illustrated in FIG. 1 as well as in FIGS. 7A to 7C, to a proximal position as illustrated in FIG. 7D. Even when the insertion sleeve 128 is released from the medical device 112, specifically from the housing 232 of the medical device 112, the elastic member 130 may be pre-tensioned. Further, the insertion system 110 may stay in the cocked mode. Thus, the wing 136 may be configured to block the movement of the insertion component retractor 120 within the locking sleeve 126.

[0186] In FIG. 7E, the insertion system 110 is separated from the medical device 112. A separation of the insertion device from the medical device releases a movement of the locking sleeve from its proximal position, as shown in FIG. 7D, to a further proximal position. The further proximal position is illustrated in FIG. 7E.

[0187] The movement of the locking sleeve 126 from its proximal position to the further proximal position may be a helical movement of the locking sleeve 126. Specifically, the helical movement of the locking sleeve 126 may be a helical movement of the locking sleeve 126 within the insertion sleeve 128. The movement of the locking sleeve 126 from its proximal position to the further proximal position may release a movement of the insertion component retractor 120 from its proximal position to a retracted position. Thus, the movement of the locking sleeve 126 from its proximal position to the further proximal position may release a movement of the insertion component retractor 120 away from the skin site of the user into an interior of the insertion device 113. A direction 260 of the movement of the insertion component retractor 120 from its proximal position to the retracted position may be an opposite direction 262 of the movement of the locking sleeve 126 from its proximal position to the further proximal position.

[0188] A rotational movement of the locking sleeve 126 within the insertion sleeve 128 may cause at least partial alignment of the first locking sleeve slot 240 and the insertion sleeve slot 186 such that the wing 136 of the insertion component retractor 120 is movable. Thus, the rotational movement of the locking sleeve 126 within the insertion sleeve 128 may cause the wing 136 of the insertion component retractor 120 being received in the straight section 246 of the first locking sleeve slot 240 and the wing 136 may be moveable in the straight section 246 of the first locking sleeve slot 240. The elastic member 130 may be actuable by separating the insertion component 118 from the medical device 112. The elastic member 130 may be configured for moving the insertion component retractor 120 to its retracted position. Thereby the insertion component 118 may be retracted into the insertion device 113.

[0189] After the movement of the insertion component retractor 120 from its proximal position to the retracted position, the insertion component 118 may be fully encircled by at least one of the locking sleeve 126, the insertion sleeve 128 and/or the guide sleeve 124. Further, the insertion component 118 may be fully received in the receptacle 234 of the locking sleeve 126 as descripted above.

LIST OF REFERENCE NUMBERS

[0190] 110 insertion system [0191] 112 medical device [0192] 113 insertion device [0193] 114 analyte sensor [0194] 116 electronic component [0195] 118 insertion component [0196] 119 plunger [0197] 120 insertion component retractor [0198] 122 cap [0199] 124 guide sleeve [0200] 126 locking sleeve [0201] 128 insertion sleeve [0202] 130 elastic member [0203] 132 gripper [0204] 134 proximal end [0205] 136 wing [0206] 138 insertion direction [0207] 139 axis of extension [0208] 142 proximal end [0209] 144 proximal side [0210] 148 distal side [0211] 150 inner structure [0212] 152 cap latching element [0213] 154 inner guide sleeve latching element [0214] 156 inner side [0215] 157 first inner guide sleeve latching element [0216] 158 gripper [0217] 160 second inner guide sleeve latching element [0218] 162 guide rail [0219] 164 protrusion [0220] 166 first end of the guide rail [0221] 168 second end of the guide rail [0222] 176 rotational symmetric hollow center [0223] 178 distal end of insertion sleeve [0224] 180 proximal end of insertion sleeve [0225] 182 first cylindrically shaped component [0226] 184 second cylindrically shaped component [0227] 186 insertion sleeve slot [0228] 188 trench cut [0229] 200 straight slot [0230] 202 inward protrusion [0231] 204 support surface [0232] 206 dead stop [0233] 208 lower end of the second cylindrically shaped component [0234] 210 insertion sleeve latching element [0235] 212 outer side [0236] 214 insertion sleeve latching element [0237] 216 insertion sleeve guide rail [0238] 218 resting surface [0239] 220 guide receptacle [0240] 222 receptacle of the insertion sleeve guide rail [0241] 224 first end of the guide receptacle [0242] 226 second end of the guide receptacle [0243] 228 holding element [0244] 230 inner surface [0245] 232 housing [0246] 234 receptacle of the locking sleeve [0247] 236 opening [0248] 238 distal end [0249] 240 first locking sleeve slot [0250] 242 second locking sleeve slot [0251] 244 edge [0252] 246 straight section [0253] 248 inclined wing surface [0254] 250 inclined surface [0255] 252 spring [0256] 254 lower end of the elastic member [0257] 256 upper end of the elastic member [0258] 258 bottom [0259] 260 direction of the movement of the insertion component retractor [0260] 262 direction of the movement of the locking sleeve