Insertion device and method for inserting a medical device

Abstract

An insertion device (111), an insertion system (110) and a method for inserting a medical device (112) into a skin of a user are disclosed. The insertion device (111) comprises: - an insertion component (114) configured for inserting an insertable part (116) of the medical device (112) into the skin of the user; - an insertion component retractor (118) configured for engaging with the insertion component (114); - at least one elastic member (120) configured for driving a retraction movement of the insertion component retractor (118); and - at least one guiding structure (122) configured for guiding the retraction movement of the insertion component retractor (118); wherein the guiding structure (122) is configured for continuously slowing down a final part of the retraction movement of the insertion component retractor (118).

Description

[0001] December 19, 2025

[0002] Insertion device and method for inserting a medical device

[0003] Technical Field

[0004] The invention relates to an insertion device for inserting a medical device into a skin of a user, an insertion system, and a method for inserting a medical device into a skin of a user. The medical device may specifically be configured for detecting at least one analyte in a body fluid of the user. The insertion device, the insertion system and the method may be applied in the field of continuous monitoring of the analyte in the body fluid of the user, specifically in the field of home care and / or in the field of professional care, such as in hospitals. Other applications, however, are also feasible.

[0005] Background art

[0006] Monitoring certain body functions, more particularly monitoring one or more analyte concentrations such as one or more metabolite concentration in a body fluid of a user plays an important role in the prevention and treatment of various diseases. Such analytes can include by way of example, but not exclusively, glucose, lactate, cholesterol or other types of analytes and metabolites. Without restricting further possible applications, the invention will be described in the following text with reference to glucose monitoring. However, additionally or alternatively, the invention can also be applied to other types of analytes, such as the analytes mentioned above. The invention may also be applied to other medical devices which are to be inserted into the skin of the user.

[0007] Generally, systems for long-term monitoring of an analyte in a body tissue of a user as well as corresponding insertion devices are known.US 11,529,099 B2 discloses a sensor applicator assembly for a continuous glucose monitoring system and provides a sensor applicator assembly for a continuous glucose monitoring system, which is manufactured with a sensor module assembled inside an applicator. A battery is built in the sensor module and a separate transmitter is connected to the sensor module so as to receive power supply from the sensor module and be continuously used semi -permanently. The sensor module and the applicator are used as disposables.

[0008] US 2024 / 0173472 Al discloses devices, systems, and methods for assisting with transcuta-neously implanting a cannula used for delivering medication (e.g., insulin). The implanted cannula may be used with a patch pump adhered to a wearer's body. An enhanced applicator needle is provided to cause the cannula transition from a straight configuration to a curved configuration during deployment within the skin. The applicator needle has a structural modification to cause the needle, and thereby cause the cannula having the needle positioned therein, to curve within the skin, for example, a special cut pattern at the needle tip and / or a bend at the distal region of the needle. Once transcutaneously implanted in the curved manner, the needle is fully withdrawn from the cannula so that a patch pump can be fluidly coupled to the curved cannula for transcutaneously delivering medication to a target infusion area beneath the wearer's outer skin layer.

[0009] US 12,005,240 B2 discloses an auto-injector for administering a dose of a liquid medicament having a tubular chassis telescopable in a tubular case, a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, where the carrier is adapted to contain a syringe with a hollow injection needle. The injector also has a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier. A control spring is arranged around the carrier for translating the carrier in a proximal direction for insertion of the needle through the chassis into an injection site.

[0010] Despite the advantage achieved by the known methods and devices, several technical challenges remain. Generally, a medical device may be inserted using an insertion component, such as a needle. Such systems may comprise a mechanism which retracts the insertion component after the insertion of the medical device into the skin of the user . The insertion component may be retracted into the housing of the system to minimize the infection risk. The retraction of the insertion component may be initiated mechanically after insertion movement of the insertion component into the skin. This retraction of the insertion component may result in a hard impact of the inserter parts at the end of the retraction movement. Thismay result in an uncomfortable impact on a users’ palm and may potentially cause unwanted noise.

[0011] Problem to be solved

[0012] It is therefore desirable to provide an insertion device, an insertion system, and a method which at least partially address the above-mentioned technical challenges. Specifically, an insertion device shall be proposed which allows a safe and user-friendly handling of the insertion device while ensuring a reliable retraction of a medical device after insertion into a body tissue of a user.

[0013] Summary

[0014] This problem is addressed by an insertion device for inserting a medical device into a skin of a user, an insertion system, and a method for inserting a medical device into a skin of a user with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

[0015] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0016] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0017] In a first aspect, an insertion device for inserting a medical device into a skin of a user is disclosed. The insertion device comprises:

[0018] an insertion component configured for inserting an insertable part of the medical device into the skin of the user;

[0019] an insertion component retractor configured for engaging with the insertion component;

[0020] at least one elastic member configured for driving a retraction movement of the insertion component retractor from a start position to a stop position; and

[0021] at least one guiding structure configured for guiding the retraction movement from the start position to the stop position of the insertion component retractor.

[0022] The guiding structure is configured for continuously slowing down a final part of the retraction movement of the insertion component retractor before reaching the stop position.

[0023] The term “inserting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an action or process of one or more of transcutaneously or subcutaneously implanting and / or positioning the medical device into the skin of the user. The insertion of the medical device may be performed by using the insertion device, specifically by the user using the insertion device. The medical device may fully or partially be inserted into the body tissue. For example, the medical device may be an analyte sensor and the inserting of the medical device may comprise an insertion of the insertable part of the analyte sensor into the skin of the user, wherein a remaining part of the analyte sensor remains outside of the skin of the user, e.g. connected to a sensor unit. After insertion, the medical device, specifically the insertable part of the medical device, may remain in the skin of the user for a predetermined period of time, suchas 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.

[0024] The term “insertion device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device configured for inserting the medical device into the skin of the user. The insertion device may be configured for transcutaneously or subcutaneously inserting the medical device, such as by performing an incision or a puncture in the skin of the user and by transferring the medical device fully or partially into the body tissue underneath the skin.

[0025] The term “medical device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to 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 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. The medical device may be configured for continuously monitoring and / or detecting the analyte in a body fluid present in the skin of the user.

[0026] For example, the medical device may comprise, specifically may be, at least one element selected from the group consisting of: an analyte sensor configured for detecting at least one analyte in a body fluid of the user; an infusion cannula for delivering liquid medication to the user.

[0027] The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to 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.

[0028] The term “analyte sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a specialor customized meaning. The term specifically may refer, without limitation, to a sensor which is capable of qualitatively or quantitatively detecting the presence and / or the concentration of the at least one analyte. As used herein, the term "detecting" refers to a quantitative and / or qualitative determination of an analyte concentration, i.e. a determination of the amount and / or concentration of the analyte in a body fluid and / or the response to the question of whether the analyte is present in a body fluid. As used herein, the term "body fluid" relates to all bodily fluids of a user known to comprise or suspected to comprise the analyte of the present invention, including interstitial fluid, blood, plasma, lymph, and the like. Generally, an arbitrary type of body fluid may be used. Preferably, the body fluid is a body fluid which is present in the skin of the user, such as in the interstitial tissue. Thus, as an example, the body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids may be used. The body fluid generally may be contained in a body tissue, specifically in the skin of the user. Thus, generally, the detection of the at least one analyte in the body fluid may preferably be determined in vivo.

[0029] The term “user” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to person intending to monitor an analyte value, such as a glucose value, under the skin of the person and / or to deliver medication, such as insulin, under the person’s skin. In an embodiment, the term specifically may refer, without limitation, to a person using the insertion device. However, in an embodiment, the person using the insertion device is different from the user. For example, the medical device may be inserted by a person different from the user under the user’s skin. For example, the user may be a patient suffering from a disease, such as diabetes.

[0030] The term “skin” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to at least one or all skin layers, specifically an upper skin layer such as the epidermis and the dermis or a lower skin layer such as the subscutis or sub layers of these layers such as the cornea. The term “into the skin” may refer, without limitation, to a location in and / or underneath a specific skin layer and / or between specific skin layers.

[0031] The term “infusion cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to aspecial or customized meaning. The term specifically may refer, without limitation, to a hollow tube configured for delivering and / or infusing a medication to the user. For example, the infusion cannula may be configured for delivering and / or infusing insulin to the user.

[0032] As outlined above, the insertion device comprises the insertion component configured for inserting the insertable part of the medical device into the skin of the user. The term “insertion component” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element which may be insertable at least partially into the body tissue, particularly in order to deliver or to transfer a further element. The insertion component may be configured for supporting the insertion of the medical device. The insertion component may comprise a tip or a sharp end for inserting the medical device into the skin of the user. The insertion component may comprise at least one element selected from the group consisting of an insertion needle; an insertion cannula. The term “insertion cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow needle which may be at least partially slotted. The medical device may be received within the insertion cannula, such as within a lumen of the insertion cannula. The term “insertion needle” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a compact needle, specifically without a slot and without any hollow parts. The medical device may be received on an outer surface of the insertion needle.

[0033] The term “insertable part” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an in vivo portion of the medical device. The medical device may specifically comprise an in vivo portion, such as a portion of the medical device which is inserted into the skin of the user, and an ex vivo portion, such as a portion which stays outside the skin of the user. The in vivo portion of the medical device may correspond to the insertable part of the medical device.

[0034] As further outlined above, the insertion device comprises the insertion component retractor configured for engaging with the insertion component. The term “insertion component retractor” as used herein is a broad term and is to be given its ordinary and customary meaningto a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one element of the insertion device configured for retracting the insertion component. The insertion component retractor may be configured for suspending the insertion component during insertion movement and pull it out from the skin of the user during the retraction movement. Specifically, the insertion component retractor may be in a resting position during the insertion movement relative to the insertion component and may be configured for engaging with the insertion component to pull it out from the skin of the user during the retraction movement.

[0035] The term “engaging” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation to an ability of an element to mechanically interact with another element. For example, the insertion component retractor may be able to mechanically interact with the insertion component. Specifically, the insertion component may comprise at least one holding element, such as one or more clamps or grips, which, when the retraction movement is initiated by the elastic member, engages directly or indirectly with the insertion component in order to retract the insertion component from the skin of the user.

[0036] As further outlined above, the insertion device comprises the at least one elastic member configured for driving the retraction movement of the insertion component retractor. The term “elastic member” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element which, when being compressed or stretched from its resting position, may exert a force opposing to the compression or stretch. The elastic member may be configured for applying the force to one or more further elements of the insertion device. Specifically, the elastic member may be compressed or stretched when the medical device is inserted into the body tissue or, alternatively, the elastic member may already be in a compressed or stretched state, such as in a pre-tensioned state, prior to use of the insertion device.

[0037] For example, the elastic member may comprise, specifically may be, a retraction spring connected to the insertion component retractor. The retraction spring may be preloaded. The preloaded retraction spring may be configured for being released when the insertion component retractor and the insertion component are in a proximal position of an insertion movement.The term “driving” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of enabling at least one movement of a first element by interaction with at least one second element providing a force to move the first element. For example, the elastic member may be configured for interacting with the insertion component retractor to provide a force enabling the retraction movement of the insertion component retractor with the insertion component.

[0038] The term “retraction movement” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a single step or a sequence of steps of withdrawing the insertion component. Specifically, the retraction movement may comprise a single step or a sequence of steps of moving the insertion component retractor, specifically from a proximal position, the start position, to a distal position, the stop position, thereby withdrawing the insertion component from the skin of the user. The retraction movement may specifically result in a complete withdrawal of the insertion component from the skin of the user, in particular such that the insertion component is fully removed from the skin of the user and, more particular, is safely received within the insertion device.

[0039] As further outlined above, the insertion device comprises the at least one guiding structure configured for guiding the retraction movement of the insertion component retractor. The term “guiding” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of providing control or influence on a movement of an element along a specific and predetermined path and / or direction. The term “guiding structure” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element involved in at least one movement, specifically in the retraction movement. Specifically, the guiding structure may be configured for guiding the retraction movement, i.e. for controlling a path and / or a direction of retraction movement of the insertion component retractor. The guiding structure may specifically be configured for physically guiding the retraction movement of the insertion component retractor from the start position to the stop position.The guiding structure may be configured for plastically deforming during the retraction movement of the insertion component retractor. For example, the guiding structure may be made from at least one plastic material, specifically from at least one thermoplastic material, such as polycarbonat-Acrylnitril-Butadien-Styrol-Blends and polypropylene.

[0040] As further outlined above, the guiding structure is configured for continuously slowing down the final part of the retraction movement of the insertion component retractor. The term “slowing down” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a decrease of a velocity of an arbitrary element in a certain period of time. For example, the velocity of the insertion component retractor may be decreased in a certain period of time, e.g a time period of passing a certain portion of the guided structure, during the retraction movement, specifically at the end of the retraction movement.

[0041] The term “continuously” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process, such as a slowing down movement, lasting steadily over a certain period of time. For example, the velocity of the insertion component retractor may be slowed down steadily over a certain amount of time until the velocity is zero, in opposite to the arbitrary element stopping abruptly.

[0042] The term “final part” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a last fraction of the retraction movement of the insertion component retractor before reaching the stop position, i.e. a portion of the retraction movement right before the stop position.

[0043] The final part of the retraction movement of the insertion component retractor may, for example, begin after the insertion component is fully retracted from the skin of the user. For example, the guiding structure may be configured for continuously slowing down the final part of the retraction movement where the insertion component is fully retracted at least from the skin of the user, specifically fully retracted in the insertion device. Thus, specifically, the slow down of the insertion component retractor with the insertion component takes place during a part of the retraction movement when the insertion component is fully removed from the skin of the user.As an example, the guiding structure may comprise at least one guiding channel for guiding at least one guiding wing of the insertion component retractor. The term “guiding channel” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to one or more of a slot, a trench cut and / or an opening in at least one element of the insertion device. The guiding channel may specifically be one or more of a slot, a trench cut and / or an opening in one or more of a guide sleeve of the insertion device, an insertion sleeve of the insertion device and an inner structure of a cap of the insertion device. The guiding channel may be a trench cut such that the guiding channel may only be partially cut into the at least one element of the insertion device. Alternatively and / or additionally, the guiding channel may be an opening such that the guiding channel may fully cut the at least one element of the insertion device. The guiding channel may extend essentially parallel to an axis of extension of the insertion device.

[0044] The term “guiding wing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one element protruding outwards the insertion component retractor, in particular perpendicular to an insertion direction. The guiding wing may be configured for interacting with the guiding structure, specifically with the guiding channel. Specifically, the guiding wing may be configured for sliding in the guiding channel for guiding the retraction movement of the insertion component retractor. The guiding wing may protrude outwards from an outside of the insertion component retractor. For example, the insertion component retractor may at least partially form a cylindrical body. The guiding wing may protrude from a lateral surface of the cylindrical body of the insertion component retractor. The insertion component retractor may comprise at least two guiding wings, e.g. one guiding wing arranged on opposing sides of the insertion component retractor.

[0045] The guiding structure may further comprise the at least one ramp narrowing, specifically continuously narrowing, a distal end of the guiding channel. The term “ramp” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element of the guiding structure comprising at least one inclined surface. The ramp may be arranged in the guiding channel such as to continuously minimize a width of the guiding channel towards its distal end. The term “distal end” as used herein is a broad term and is to be given its ordinary and customary meaning to aperson of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a position specification indicating a position of the insertion device and / or any parts thereof in relation to the user in which the insertion device and / or any parts thereof are furthermost distanced from an insertion side. Specifically, the distal end of the guiding channel may refer to a part of the guiding channel which is furthermost distanced from the insertion side. Thus, during the retraction movement, the insertion component retraction being guided by the guiding structure, specifically with the guiding wing in the guiding channel, may move from a proximal position to a distal position, specifically towards the distal position of the guiding channel. The insertion component may be fully retracted from the skin of the user, specifically fully withdrawn within the insertion device, when the insertion component retractor reaches the distal end of the guiding channel. The guiding structure may be configured for continuously slowing down the final part of the retraction movement by narrowing the guiding channel using the at least one ramp.

[0046] The ramp may be a straight ramp having an inclination angle a in the range of 0°<a<45°. The term “straight” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary shape extending uniformly in one direction only, without a bend. The term “inclination angle” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an angle that indicates the slope of a straight line or plane. The inclination angle may specifically indicate a slope of the ramp in the guiding channel.

[0047] Alternatively or additionally, the ramp may be a curved ramp. The term “curved” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary shape representing a continuous and smooth function. Specifically, a curved shape can be described by a mathematical function where the dependent variable exhibits a non-linear dependence on the independent variable. This includes, but is not limited to, curves defined by polynomial, exponential, logarithmic, and other functions that result in a non-linear trajectory.

[0048] Alternatively or additionally, the guiding structure may further comprise at least one mount configured for fixedly attaching the elastic member to the insertion component retractor. Theterm “mount” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element configured such as to secure another element. For example, the mount may be configured for securing the elastic member to the insertion component retractor. The elastic member may be connected to the insertion component retractor via the at least one mount. The elastic member may be configured for providing a restoring force on the insertion component retractor in the final part of the retraction movement of the insertion component retractor. The term “restoring force” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a force opposite to a retraction movement direction. Specifically, the restoring force of the elastic member may point in a direction opposite to a direction of the retraction movement. The restoring force may slow down the retraction movement of the insertion component retractor in the final part of the retraction movement.

[0049] Alternatively or additionally, the insertion device may further comprise a cap at least partially enclosing the insertion component retractor and the guiding structure. The term “cap” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary shaped element configured for fully or partially enclosing one or more components of the insertion device and / or for providing protection for these one or more components, such as against mechanical influence and / or humidity. The cap may surround and / or may enclose fully or partially one or more further components, such as the insertion component retractor and / or the guiding structure. The cap may be arranged such that it surrounds and / or encloses the further components of the insertion device, wherein a proximal side of the insertion device may be at least partially uncovered by the cap allowing contacting the user’s skin and movement of the insertion component out of the insertion device.

[0050] The guiding structure may comprise at least one triangular-shaped stop element, specifically three symmetrically arranged triangular-shaped stop elements, at an inner top surface of the cap pointing towards the insertion component retractor, wherein the triangular-shaped stop element may be configured for clamping the insertion component retractor at the final part of the retraction movement. The term “stop element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and isnot to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element braking the movement of a further arbitrary element by blocking a further movement path of the further arbitrary element. Specifically, the stop element may be configured to continuously blocking the retraction movement of the insertion component retractor such that the retraction movement is continuously slow downed. The stop element may be configured for blocking the insertion component retractor by clamping it. Specifically, the stop element may be configured for blocking the retraction movement of the insertion component retractor by clamping the insertion component retractor in the final part of the retraction movement. The guiding structure may be configured for stopping the retraction movement of the insertion component retractor at a distal position in which the insertion component retractor is not in contact with an inner top surface of the cap.

[0051] The insertion device may further comprise at least one insertion mechanism configured for driving an insertion movement of the insertion component retractor and the insertion component holding the insertable part of the medical device, specifically into the skin of the user. The term “insertion mechanism” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary mechanism configured to enable an insertion movement of the insertion component. Specifically, the insertion mechanism may be configured for enabling, specifically for driving, an insertion movement of the insertion component such that the insertable part of the medical device is inserted into the skin of the user.

[0052] In a further aspect, an insertion system is disclosed. The insertion system comprises the insertion device according to the present invention, 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. Thus, for definitions of terms and / or for possible embodiments, reference is made to the description of the insertion device above. The insertion system further comprises the medical device. The medical device may comprise at least one adhesive patch configured for being attached onto the skin of the user. For example, the insertion system may comprise, specifically may be, a continuous glucose monitoring (CGM) system. However, other examples, such as insulin pumps are also feasible.

[0053] In a further aspect, a method for inserting a medical device into a skin of a user is disclosed. The method comprises using at least one insertion device according to the present invention, 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. Thus, for definitions of termsand / or for possible embodiments, reference is made to the description of the insertion device above.

[0054] The method comprise the following method steps. The method steps may be performed in the given order. However, other orders of the method steps are feasible. Further, one or more of the method steps may be performed in parallel and / or on a timely overlapping fashion. Further, one or more of the method steps may be performed repeatedly. Further, additional method steps may be present which are not listed.

[0055] The method comprises the following steps:

[0056] a) inserting the insertable part of the medical device into the skin of the user;

[0057] b) retracting the insertion component from the skin of the user via a retraction movement of the insertion component retractor driven by the elastic member; and

[0058] c) continuously slowing down at least a part of the retraction movement of the insertion component retractor.

[0059] The insertable part of the medical device may be inserted into an upper skin layer of the user comprising at least one of an epidermis skin layer and a dermis skin layer.

[0060] The method may specifically be an in vivo method. Further, the method may comprise steps in addition to those explicitly mentioned above. For example, further steps may relate, e.g., to disinfecting the skin site before insertion. As is understood by the skilled person, the method does not require specific medical skills and does not impose a significant health risk on the user and, thus, is usually performed by the user receiving said medical device itself. Thus, the method may be a method of self-administration.

[0061] The methods and devices according to the present invention provide a large number of advantages over known methods and devices. Specifically, the insertion device according to the present invention may a safe and user-friendly handling of the insertion device while ensuring a reliable retraction of a medical device after insertion into a body tissue of a user.

[0062] When applying the CGM device, the palm of the hand usually rests on the cap. When retracting the insertion component, specifically the needle, an insertion component retractor may be accelerated by a pre-tensioned spring. Thereby, the insertion component is retracted from the skin the user. At the end of the retraction movement, the insertion component retractor may hit the cap and, thereby resulting in an impact on the palm of the user due to atransfer of momentum. The impact may be clearly noticeable and uncomfortable. Specifically, a spring force of 10 Newton may required to pull the insertion component out from the skin of the user. The present invention may ensure a cautious deceleration of the insertion component retractor to reduce the force of the impact. This may have an effect on the sound level as well as the transfer of momentum. The deceleration may be achieved using a ramp and, thereby, narrowing the guiding channel such that due to the minimal plastic deformation, the kinetic energy is successively absorbed. Due to the ramp, the guiding channel may be successively narrowed such that the insertion component is clamped at the end of the channel. The insertion component retractor may stop completely before reaching the inner surface of the cap. Thereby, the transfer of momentum is at least reduced, specifically is non-existent.

[0063] The present invention may relate to an improved application device, e.g. for a subcutaneously insertable analyte sensor. An advantage of the invention may be to avoid a hard impact of the insertion component retractor retracting the insertion component at the end of the retraction movement to reduce noise and impact on a user’s palm. This may be achieved by including a guiding structure configured for slowing down the final part of the retraction movement of the insertion component retractor. To do so, the guiding structure may comprise a ramp narrowing the guiding channel towards the end of the guiding channel guiding at least one retracting part of the application aid.

[0064] The present invention may be implemented by a small adaption of the guiding structure. No further components or parts may be necessary. Therewith, an advantage of the invention may be the price efficiency and the rather easy implementation.

[0065] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0066] Embodiment 1. An insertion device for inserting a medical device into a skin of a user, the insertion device comprising:

[0067] an insertion component configured for inserting an insertable part of the medical device into the skin of the user;

[0068] an insertion component retractor configured for engaging with the insertion component;

[0069] at least one elastic member configured for driving a retraction movement of the insertion component retractor; andat least one guiding structure configured for guiding the retraction movement of the insertion component retractor;

[0070] wherein the guiding structure is configured for continuously slowing down a final part of the retraction movement of the insertion component retractor.

[0071] Embodiment 2. The insertion device according to the preceding embodiment, wherein the guiding structure comprises at least one guiding channel for guiding at least one guiding wing of the insertion component retractor.

[0072] Embodiment 3. The insertion device according to the preceding embodiment, wherein the guiding structure further comprises at least one ramp narrowing, specifically continuously narrowing, a distal end of the guiding channel.

[0073] Embodiment 4. The insertion device according to the preceding embodiment, wherein the ramp is a straight ramp having an inclination angle a in the range of 0°<a<45°.

[0074] Embodiment 5. The insertion device according to any one of the two preceding embodiments, wherein the ramp is a curved ramp.

[0075] Embodiment 6. The insertion device according to any one of the four preceding embodiments, wherein the guiding structure further comprises at least one mount configured for fixedly attaching the elastic member to the insertion component retractor.

[0076] Embodiment 7. The insertion device according to the preceding embodiment, wherein the elastic member is configured for providing a restoring force on the insertion component retractor in the final part of the retraction movement of the insertion component retractor.

[0077] Embodiment 8. The insertion device according to any one of the preceding embodiments, wherein the insertion device further comprises a cap at least partially enclosing the insertion component retractor and the guiding structure.

[0078] Embodiment 9. The insertion device according to the preceding embodiment, wherein the guiding structure comprises at least one triangular-shaped stop element, specifically three symmetrically arranged triangular-shaped stop elements, at an inner top surface of the cap pointing towards the insertion component retractor, wherein the triangular-shaped stop element is configured for clamping the insertion component retractor at the final part of the retraction movement.Embodiment 10. The insertion device according to any one of the two preceding embodiments, wherein the guiding structure is configured for stopping the retraction movement of the insertion component retractor at a distal position in which the insertion component retractor is not in contact with an inner top surface of the cap.

[0079] Embodiment 11. The insertion device according to any one of the preceding embodiments, wherein the guiding structure is configured for plastically deforming during the retraction movement of the insertion component retractor.

[0080] Embodiment 12. The insertion device according to the preceding embodiment, wherein the guiding structure is made from at least one plastic material, specifically from at least one thermoplastic material, such as polycarbonat-Acrylnitril-Butadien-Styrol-Blends and polypropylene.

[0081] Embodiment 13. The insertion device according any one of the preceding embodiments, wherein the guiding structure is configured for continuously slowing down the final part of the retraction movement where the insertion component is fully retracted at least from the skin of the user, specifically fully retracted in the insertion device.

[0082] Embodiment 14. The insertion device according to any one of the preceding embodiments, wherein the medical device comprises, specifically is, at least one element selected from the group consisting of: an analyte sensor configured for detecting at least one analyte in a body fluid of the user; an infusion cannula for delivering liquid medication to the user.

[0083] Embodiment 15. The insertion device according to any one of the preceding embodiments, wherein the insertion component comprises at least one element selected from the group consisting of: an insertion needle; an insertion cannula.

[0084] Embodiment 16. The insertion device according to any one of the preceding embodiments, wherein the elastic member comprises, specifically is, a retraction spring connected to the insertion component retractor.

[0085] Embodiment 17. The insertion device according to the preceding embodiment, wherein the retraction spring is preloaded, wherein the preloaded retraction spring is configured for being released when the insertion component retractor and the insertion component are in a proximal position of an insertion movement.Embodiment 18. The insertion device according to any one of the preceding embodiments, wherein the insertion device further comprises at least one insertion mechanism configured for driving an insertion movement of the insertion component retractor and the insertion component holding the insertable part of the medical device.

[0086] Embodiment 19. An insertion system comprising the insertion device according to any one of the preceding embodiments and the medical device.

[0087] Embodiment 20. The insertion system according to the preceding embodiment, wherein the medical device comprises at least one adhesive patch configured for being attached onto the skin of the user.

[0088] Embodiment 21. The insertion system according to any one of the two preceding embodiments, wherein the insertion system comprises, specifically is, a continuous glucose monitoring (CGM) system.

[0089] Embodiment 22. A method for inserting a medical device into a skin of a user, the method comprising using at least one insertion device according to any one of the preceding embodiments referring to an insertion device, the method further comprising:

[0090] a) inserting the insertable part of the medical device into the skin of the user;

[0091] b) retracting the insertion component from the skin of the user via a retraction movement of the insertion component retractor driven by the elastic member; and

[0092] c) continuously slowing down at least a part of the retraction movement of the insertion component retractor.

[0093] Embodiment 23. The method according to the preceding embodiment, wherein the insertable part of the medical device is inserted into an upper skin layer of the user comprising at least one of an epidermis skin layer and a dermis skin layer.

[0094] Short description of the Figures

[0095] 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 isnot 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.

[0096] In the Figures:

[0097] Figure 1 shows an embodiment of an insertion system in a sectional view;

[0098] Figures 2 and 3 show a detailed view of the insertion device from the embodiment of Figure 1; and

[0099] Figure 4 shows a method for inserting a medical device into the skin of the user.

[0100] Detailed description of the embodiments

[0101] In Figures 1 to 3, an exemplary embodiment of an insertion system 110 is shown. Specifically, Figure 1 shows the insertion system 110 in a sectional view along a median, whereas Figures 2 and 3 show detailed views of an insertion device 111 of the insertion system 110. Thus, in the following, Figures 1 to 3 are described in conjunction.

[0102] The insertion system 110 comprises the insertion device 111 according to the present invention, such as according to the exemplary embodiment described in Figures 1 to 3 and / or according to any other embodiment disclosed herein. The insertion system 110 further comprises a medical device 112. As an example, the medical device 112 may comprise, specifically may be, an analyte sensor configured for detecting at least one analyte in a body fluid of the user. The medical device 112 may further comprise at least one adhesive patch 113 configured for being attached onto the skin of the user. Thus, in this example, the insertion system 110 may be a continuous glucose monitoring (CGM) system. However, other examples for the medical device 112, such as insulin pumps are also feasible.

[0103] The insertion device 111 is an insertion device 111 for inserting the medical device 112 into the skin of the user. As can be seen in Figure 1, the insertion device 111 comprises an insertion component 114 configured for inserting an insertable part 116 of the medical device 112 into the skin of the user. Further, the insertion device 111 comprises an insertion componentretractor 118 configured for engaging with the insertion component 114. The insertion component 114 may comprise at least one element selected from the group consisting of an insertion needle; an insertion cannula.

[0104] The insertion device 111 may comprise at least one insertion mechanism (not shown in the Figures) configured for driving an insertion movement of the insertion component retractor 118 and the insertion component 114 holding the insertable part 116 of the medical device 112. Specifically, the insertion mechanism may be configured for enabling, specifically for driving, an insertion movement of the insertion component 114 such that the insertable part 116 of the medical device 112 is inserted into the skin of the user.

[0105] The insertion device 111 comprises at least one elastic member 120 configured for driving a retraction movement 121 of the insertion component retractor 118. The elastic member 120 may comprise, specifically may be, a retraction spring connected to the insertion component retractor 118. The retraction spring may be preloaded, wherein the preloaded retraction spring may be configured for being released when the insertion component retractor 118 and the insertion component 114 are in a proximal position of an insertion movement.

[0106] Further, the insertion device 111 comprises at least one guiding structure 122 configured for guiding the retraction movement 121 of the insertion component retractor 118, as can be seen best in Figures 2 and 3. The guiding structure 122 is configured for continuously slowing down a final part of the retraction movement 121 of the insertion component retractor 118. The guiding structure 122 may be configured for plastically deforming during the retraction movement 121 of the insertion component retractor 118. The guiding structure 122 may be made from at least one plastic material, specifically from at least one thermoplastic material, such as polycarbonat-Acrylnitril-Butadien-Styrol-Blends and polypropylene. The guiding structure 122 may specifically be configured for continuously slowing down the final part of the retraction movement 121 where the insertion component 114 is fully retracted at least from the skin of the user, specifically fully retracted in the insertion device 111.

[0107] As shown in Figures 2 and 3, the guiding structure 122, in this exemplary embodiment, may comprise at least one guiding channel 126 for guiding at least one guiding wing 128 of the insertion component retractor 118. The guiding structure 122 may further comprise at least one ramp 132 narrowing, specifically continuously narrowing, a distal end 130 of the guiding channel 126. As shown in Figures 2 and 3, the ramp 132 may be a straight ramp. Thestraight ramp may have an inclination angle 134 a in the range of 0°<a<45°. Alternatively or additionally, the ramp 132 may be a curved ramp.

[0108] However, other means for continuously slowing down the final part of the retraction movement 121 of the insertion component retractor 118 are also feasible. For example, the guiding structure 122 may additionally or alternatively comprise at least one mount (not shown in the Figures) configured for fixedly attaching the elastic member 120 to the insertion component retractor 118. The elastic member 120 may be configured for providing a restoring force on the insertion component retractor 118 in the final part of the retraction movement 121 of the insertion component retractor 118.

[0109] Alternatively or additionally, the insertion device 111 may further comprise a cap 136 at least partially enclosing the insertion component retractor 118 and the guiding structure 122, as can be seen in Figures 1 and 2. The guiding structure 122 may alternatively or additionally comprise at least one tri angular- shaped stop element (not shown), specifically three symmetrically arranged triangular-shaped stop elements, at an inner top surface of the cap 138 pointing towards the insertion component retractor 118, wherein the triangular-shaped stop element may be configured for clamping the insertion component retractor 118 at the final part of the retraction movement 121. The guiding structure 122 may be configured for stopping the retraction movement 121 of the insertion component retractor 118 at a distal position in which the insertion component retractor 118 is not in contact with an inner top surface of the cap 138.

[0110] Further, as can be seen in Figure 3, the guiding structure 122 may be configured for stopping the retraction movement 121 of the insertion component retractor 118 at a distal position in which the insertion component retractor 118 is not in contact with the inner top surface of the cap 138. Thus, the insertion device 111 according to the embodiment shown in Figures 1 to 3 may ensure a cautious deceleration of the insertion component retractor 118 to reduce the force of the impact when the insertion component retractor 118 is stopped at the distal end 130 of the guiding channel 126. Specifically, the ramp 132 in the guiding channel 126 may continuously narrow the guiding channel 126 such that the kinetic energy of the retraction movement can be successively absorbed due to plastic deformation. The insertion component retractor 118 can be stopped completely before reaching the inner top surface of the cap 138. Thereby, the transfer of momentum during the retraction movement 121 from the insertion component retraction 118 to the cap 136 is at least reduced, specifically is nonexistent.Figure 4 shows a flow chart of an exemplary embodiment of a method for inserting the medical device 112 into the skin of the user. The method comprises using the insertion device 111 according to the present invention, such as according to the embodiment shown in Figures 1 to 3 and / or according to any other embodiment disclosed herein. Thus, for a detailed description of the insertion device 111, reference may be made to the description of Figures 1 to 3.

[0111] The method comprise the following method steps. The method steps may be performed in the given order. However, other orders of the method steps are feasible. Further, one or more of the method steps may be performed in parallel and / or on a timely overlapping fashion. Further, one or more of the method steps may be performed repeatedly. Further, additional method steps may be present which are not listed.

[0112] The method comprises:

[0113] a) (denoted by reference number 140) inserting the insertable part 116 of the medical device 112 into the skin of the user;

[0114] b) (denoted by reference number 142) retracting the insertion component 114 from the skin of the user via a retraction movement 121 of the insertion component retractor 118 driven by the elastic member 120; and

[0115] c) (denoted by reference number 144) continuously slowing down at least a part of the retraction movement 121 of the insertion component retractor 118.

[0116] Specifically, the insertable part 116 of the medical device 112 may be inserted into an upper skin layer of the user comprising at least one of an epidermis skin layer and a dermis skin layer.List of reference numbers

[0117] insertion system

[0118] insertion device

[0119] medical device

[0120] sensor patch

[0121] insertion component

[0122] insertable part

[0123] insertion component retractor

[0124] elastic member

[0125] retraction movement

[0126] guiding structure

[0127] guiding channel

[0128] guiding wing

[0129] distal end

[0130] ramp

[0131] inclination angle a

[0132] cap

[0133] inner top surface of the cap

[0134] inserting the insertable part

[0135] retracting the insertion component

[0136] continuously slowing down at least a part of the retraction movement

Claims

December 19, 2025Claims1. An insertion device (111) for inserting a medical device (112) into a skin of a user, the insertion device (111) comprising:an insertion component (114) configured for inserting an insertable part (116) of the medical device (112) into the skin of the user;an insertion component retractor (118) configured for engaging with the insertion component (114);at least one elastic member (120) configured for driving a retraction movement (121) of the insertion component retractor (118) from a start position to a stop position; andat least one guiding structure (122) configured for guiding the retraction movement (121) from the start position to the stop position of the insertion component retractor (118);wherein the guiding structure (122) is configured for continuously slowing down a final part of the retraction movement (121) of the insertion component retractor (118) before reaching the stop position.

2. The insertion device (111) according to the preceding claim, wherein the guiding structure (122) comprises at least one guiding channel (126) for guiding at least one guiding wing (128) of the insertion component retractor (118).

3. The insertion device (111) according to the preceding claim, wherein the guiding structure (122) further comprises at least one ramp (132) narrowing, specifically continuously narrowing, a distal end (130) of the guiding channel (126).

4. The insertion device (111) according to any one of the two preceding claims, wherein the guiding structure (122) further comprises at least one mount configured for fixedly attaching the elastic member (120) to the insertion component retractor (118), wherein the elastic member (120) is configured for providing a restoring force on the insertion component retractor (118) in the final part of the retraction movement (121) of the insertion component retractor (118).

5. The insertion device (111) according to any one of the preceding claims, wherein the insertion device (111) further comprises a cap (136) at least partially enclosing the insertion component retractor (118) and the guiding structure (122).

6. The insertion device (111) according to the preceding claim, wherein the guiding structure (122) comprises at least one tri angular- shaped stop element, specifically three symmetrically arranged triangular-shaped stop elements, at an inner top surface of the cap (138) pointing towards the insertion component retractor (118), wherein the triangular-shaped stop element is configured for clamping the insertion component retractor (118) at the final part of the retraction movement (121).

7. The insertion device (111) according to any one of the two preceding claims, wherein the guiding structure (122) is configured for stopping the retraction movement (121) of the insertion component retractor (118) at a distal position in which the insertion component retractor (118) is not in contact with an inner top surface of the cap (138).

8. The insertion device (111) according to any one of the preceding claims, wherein the guiding structure (122) is configured for plastically deforming during the retraction movement (121) of the insertion component retractor (118).

9. The insertion device (111) according any one of the preceding claims, wherein the guiding structure (122) is configured for continuously slowing down the final part of the retraction movement (121) where the insertion component (114) is fully retracted at least from the skin of the user, specifically fully retracted in the insertion device (Hl).

10. The insertion device (111) according to any one of the preceding claims, wherein the elastic member (120) comprises, specifically is, a retraction spring connected to the insertion component retractor (118), wherein the retraction spring is preloaded, wherein the preloaded retraction spring is configured for being released when the insertion component retractor (118) and the insertion component (114) are in a proximal position of an insertion movement.

11. An insertion system (110) comprising the insertion device (111) according to any one of the preceding embodiments and the medical device (112).

12. The insertion system (110) according to the preceding claim, wherein the medical device (112) comprises at least one adhesive patch (113) configured for being attached onto the skin of the user.

13. The insertion system (110) according to any one of the two preceding claims, wherein the insertion system (110) comprises, specifically is, a continuous glucose monitoring (CGM) system.

14. A method for inserting a medical device (112) into a skin of a user, the method comprising using at least one insertion device (111) according to any one of the preceding claims referring to an insertion device (111), the method further comprising:a) inserting the insertable part (116) of the medical device (112) into the skin of the user;b) retracting the insertion component (114) from the skin of the user via a retraction movement (121) of the insertion component retractor (118) driven by the elastic member (120); andc) continuously slowing down at least a part of the retraction movement (121) of the insertion component retractor (118).

15. The method according to the preceding claim, wherein the insertable part (116) of the medical device (112) is inserted into an upper skin layer of the user comprising at least one of an epidermis skin layer and a dermis skin layer.

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