Insertion system

Abstract

An insertion system (114) is disclosed that includes at least one screw coupling (118) configured for coupling at least one first element (110) and at least one second element (112) of the insertion system (114). The screw coupling (118) is configured such that the first element (110) and the second element (112) are assembled without rotational movement. The screw coupling (118) comprises-at least one radially flexible part (120) configured for radial movement and / or deformation when the first element (110) and the second element (112) are assembled, where the radially flexible part (120) is part of the first element (110) or the second element (112); -a resilient member (122) configured for applying a force to the screw coupling (118) in an axial direction (124), where the resilient member (122) is preloadable in the axial direction (124) during assembly of the insertion system (114).

Description

Technical Field

[0001] The present invention relates to an insertion system, a kit and a method for assembling a first element and a second element of the insertion system. The device and the method can be applied in the field of continuous monitoring of analytes in a user's body fluid, in particular in the field of home care and professional care, such as in a hospital. However, other applications are also possible. Background Art

[0002] Monitoring certain body functions, more particularly monitoring one or more analyte concentrations, such as one or more metabolite concentrations in a user's body fluids, plays an important role in the prevention and treatment of a variety of diseases. Such analytes may include, for example, but are limited to, glucose, lactate, cholesterol, or other types of analytes and metabolites by way of example. Without limiting other possible applications, the present invention will be described below with reference to glucose monitoring. However, additionally or alternatively, the present invention may also be applied to other types of analytes, such as the above-mentioned analytes.

[0003] Generally, systems for long-term monitoring of analytes in a user's body tissue and corresponding insertion devices are known. For example, US9615779B2 describes a system and method for measuring analytes in a host. A sensor applicator and a method using a button activation are described, which implants the sensor, withdraws the insertion needle, engages the transmitter with the housing, and disconnects the applicator from the housing, all in one smooth motion.

[0004] In order to connect the elements of the insertion system, a screw coupling is usually used. Generally, two options are known to the technician to install the screw coupling without clearance. First, the screw coupling can be screwed on the thread until it reaches the stop, which prevents the axial clearance caused by the tensioning of the two elements involved. The manufacturing tolerance of the thread can be compensated by the inaccuracy in the rotational orientation of the two elements. In addition, the thread can be designed to extend, taper or change the slope at one of the two elements so that the mating element remains clamped. Even in this case, the gap in the axial direction may also cause inaccuracy in the rotational orientation of the two elements. The second option can be used to press on the thread. Even in this case, a certain axial gap may be required to snap into the final position. The gap must be designed according to the slope and / or depth of the thread, but it is always greater than zero. Therefore, however, the two specified options may have the disadvantage that there is an axial gap in the defined orientation, or if no gap is allowed, there is an inaccuracy in the rotational orientation. In terms of connection, for example, due to technical limitations, there may be a problem of gap in the axial direction in the case where the orientation of the predefined rotation must be maintained. Said play can only be reduced by using additional elements which reduce the play once the rotational orientation is achieved.

[0005] In other technical fields, screw couplings are used, as described, for example, in US 1,0371,870 B2 or DE 10 2016208367 A1.

[0006] Despite the advantages achieved by the above-described devices, several technical challenges remain. For example, improving the accuracy of the screw coupling of the elements of the insertion system to avoid thread play and inaccuracies in the relative rotational orientation of the two screw coupling components remains an unsolved problem.

[0007] Issues to be resolved

[0008] Therefore, it is desirable to provide insertion systems, kits and methods that at least partially address the above technical challenges. In particular, it is desirable to have a helical coupling for an insertion system that allows for a defined rotational and axial position of the helical coupling to be achieved simultaneously. Summary of the invention

[0009] This problem is solved by an insertion system, a kit and a method having the features of the independent claims. In the dependent claims and throughout the description, advantageous embodiments are listed which can be realized individually or in any combination.

[0010] As used hereinafter, the terms "have", "comprise" or "include" or any grammatical variations thereof are used in a non-exclusive manner. Thus, these terms may refer to the absence of other features in the entity described in this context in addition to the features introduced by these terms, or the presence of one or more other features. As an example, the expressions "A has B", "A includes B" and "A includes B" may refer to the absence of other elements in A in addition to B (i.e., the presence of A solely and exclusively consisting of B); or to the presence of one or more other elements in entity A in addition to B (such as element C, element C and element D, or even other elements).

[0011] Further, it should 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 are usually used only once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, the expression "at least one" or "one or more" is not repeated despite the fact that the corresponding feature or element may be present only once or more times.

[0012] Further, as used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features without limiting the possibility of alternatives. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will recognize, the present invention can be carried out 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 limitation on alternative embodiments of the invention, without any limitation on the scope of the invention, and without any limitation on the possibility of combining the features introduced in this manner with other optional or non-optional features of the invention.

[0013] In a first aspect of the present invention, an insertion system is disclosed.

[0014] As used herein, the term "system" is a broad term, and will be given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a group of elements that can interact with each other to achieve at least one common function. At least two elements may be processed independently or may be connected, connectable or integrated to form a common device. As used herein, the term "insertion system" is a broad term, and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a group of elements that can interact with each other so that at least one of the elements is inserted into the user's body tissue at least once percutaneously or subcutaneously, such as by incising or puncturing in the user's skin and by transferring at least one of the elements completely or partially into the body tissue. The insertion system may be constructed to insert a medical device percutaneously or subcutaneously into the body tissue, such as by incising or puncturing in the user's skin and by transferring the medical device completely or partially into the body tissue.

[0015] As used herein, the term "medical device" is a broad term and is to be given its ordinary and customary meaning to those of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any element or object constructed for use in the field of medical technology, specifically in the field of medical analysis or medical diagnosis. A medical device may be constructed to perform at least one medical function and / or be used in at least one medical procedure, such as one or more of a therapeutic procedure, a diagnostic procedure, or another medical procedure.

[0016] For example, the medical device may be or may include at least one analyte sensor for detecting at least one analyte in a body fluid contained in a user's body fluid (such as a user's body tissue). The analyte sensor may be constructed for qualitative and / or quantitative detection of at least one analyte. The term "analyte" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a chemical and / or biological substance that participates in the metabolism of the user's body. Specifically, the analyte may be a metabolite or a combination of two or more metabolites. As an example, the analyte may be selected from a group consisting of the following items: glucose, lactic acid, triglycerides, cholesterol. Other analytes or a combination of two or more analytes may still be detected. Body tissue may specifically be or may include adipose tissue and / or interstitium. However, other types of body tissue are also feasible.

[0017] As used herein, the term "analyte sensor" is a broad term and is given the ordinary and customary meaning to those of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a sensor capable of qualitatively or quantitatively detecting the presence and / or concentration of at least one analyte.

[0018] The analyte sensor may be an electrochemical analyte sensor. The analyte sensor may include at least two electrodes. Specifically, the analyte sensor may include at least one dual-electrode sensor. The dual-electrode sensor may precisely include two electrodes, such as a working electrode and at least one other electrode such as a relative electrode, for example a working electrode and a combined relative / reference electrode. The working electrode may include a working electrode pad and at least one test chemical optionally disposed thereon. The relative electrode may include a relative electrode pad. Additionally and optionally, one or more redox materials may be disposed thereon. The analyte sensor may further include one or more leads for electrically contacting the electrodes. The leads may be connected to one or more electronic components during insertion or at a later point in time. For example, the leads may have been connected to the electronic components before the analyte sensor is inserted. For example, the analyte sensor may be a needle-shaped or strip-shaped analyte sensor having a flexible substrate and an electrode disposed thereon. As an example, the analyte sensor may have a total length of 5 mm to 50 mm, specifically 7 mm to 30 mm. The term "total length" within the context of the present invention relates to the total length of the analyte sensor, which means the portion of the analyte sensor inserted and the portion of the analyte sensor that may remain outside the body tissue. The portion of the analyte sensor that is inserted is also referred to as the in vivo portion, and the portion of the analyte sensor that can remain outside the body tissue is also referred to as the in vitro portion. For example, the in vivo portion has a length in the range of 3 mm to 12 mm. The analyte sensor may further include a biocompatible cover, such as a biocompatible film, which completely or partially covers the analyte sensor and prevents the test chemicals from migrating into the body tissue and allows body fluids and / or analytes to diffuse to the electrodes. Other embodiments of the electrochemical analyte sensor, such as a three-electrode sensor, may be feasible. For example, in addition to the working electrode and the relative electrode, the three-electrode sensor may include a reference electrode.

[0019] The analyte sensor may be an optical analyte sensor. For example, the analyte sensor may include a flexible light guide having a glucose sensitive coating at its end and / or a tubular carrier having a functional element at the inner or outer wall. Other embodiments of the analyte sensor are also possible.

[0020] For example, the medical device may be or may include at least one infusion cannula. As used herein, the term "infusion cannula" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, a hollow tube that is configured to deliver and / or infuse a drug into a user's body tissue, such as for delivering and / or infusing insulin into a user's body tissue.

[0021] The medical device may include at least one component that can be configured to remain outside of body tissue. Further, the medical device may include at least one insertable portion. The insertable portion may be configured to be inserted into the body tissue of a user. Specifically, the insertion system may be configured to insert the insertable portion of the medical device into the body tissue of the user. The medical device, specifically the insertable portion of the medical device, may include at least one device selected from the group consisting of: an analyte sensor for detecting at least one analyte in a body fluid of the user, an infusion cannula, and a stimulation electrode. Other embodiments may be feasible.

[0022] The medical device can be constructed to be installed on the skin part of the user's limb. The limb can be selected from the group consisting of the following items: arm, specifically upper arm; abdomen; shoulder; back; buttocks; leg. Specifically, the limb can be an upper arm. However, other applications may also be feasible. The term "user" as used herein is a broad term and is given its common and customary meaning for ordinary technicians in the field, and is not limited to a special or customized meaning. The term specifically relates to a person who wants to monitor the analyte value (such as glucose value) in the body tissue of the person and / or deliver a drug (such as insulin) to the body tissue of the person. In an embodiment, the term specifically can refer to but is not limited to a person using an 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 into the body tissue of the user by a person different from the user. For example, the user can be a patient with a disease (such as diabetes).

[0023] The term "insertion" as used herein is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, one or more actions or processes of percutaneously or subcutaneously implanting and / or inserting a medical device into a user's body tissue. A medical device, such as an analyte sensor, may be inserted completely or partially into body tissue. The insertion of the medical device may be performed by using an insertion system. After insertion, the medical device or at least a portion of the medical device may stay in the user's body tissue for a predetermined period of time, such as several hours, specifically one or more days, more specifically up to a week, and even more specifically up to two weeks or more. The medical device may be constructed for continuous monitoring and / or detection of analytes in the user's body fluids.

[0024] The insertion system may include at least one insertion component, which is configured to insert a medical device into the user's body tissue. The term "insertion component" as used herein is a broad term and is given its common and customary meaning for those of ordinary skill in the art, and is not limited to a special or custom meaning. The term specifically may refer to, but is not limited to, any element that can be at least partially inserted into body tissue, particularly for the purpose of delivering or transferring other elements. The insertion component may be configured to support the insertion of a medical device. Specifically, the insertion component may be configured to support the insertion of an insertable portion of a medical device. The insertion component may include a tip or a pointed tip for inserting a medical device, particularly an insertable portion of a medical device, into body tissue. The insertion component may be or may include an insertion cannula or an insertion needle. In the context of the present invention, the insertion component is considered to be a part of the insertion device. However, particularly during the manufacture of the insertion system, the insertion component may also be considered to be a part of the medical device. The term "insertion cannula" as used herein is a broad term and is given its common and customary meaning for those of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a hollow needle that may be at least partially slotted. The medical device may be received within an insertion cannula, such as within the lumen of the insertion cannula. The term "insertion needle" as used herein is a broad term and is given its ordinary and customary meaning to one of ordinary skill in the art and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, a compact needle, specifically one without a slot and without any hollow portion. The medical device may be received on the outer surface of the insertion needle.

[0025] After insertion, the medical device, in particular the insertable portion of the medical device, may at least partially remain in the user's body tissue. However, after the medical device is inserted, the insertion component may be retracted from the user's body tissue into the insertion device. In order to retract the insertion component, the insertion system may include at least one insertion component retractor. The term "insertion component retractor" as used herein is a broad term and is given its ordinary and customary meaning to a person of ordinary skill in the art and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, at least one element of the insertion system that is configured to retract the insertion component. The insertion component retractor may be configured to suspend the insertion component during the insertion movement and to pull it out of the user's skin during the retraction movement. The engagement between the insertion component retractor and the insertion component may be loose, in particular not fixed. The engagement between the insertion component retractor and the insertion component may be established during the production process. The insertion component retractor may include at least one finger, a clamp, a hook, a forceps, etc., which is configured to retract the insertion component. Fingers, grippers, hooks, pliers, etc. can be arranged at the proximal end of the insertion member retractor, wherein the proximal end of the insertion member retractor can be directed toward the user's body tissue when the insertion device is in use. For example, the insertion member retractor can include two or more fingers, grippers, hooks or pliers symmetrically arranged around the insertion member. For example, the insertion device can include at least one plunger or pull rod connected to the insertion member. The insertion member retractor can be connected to the plunger or push rod and / or can be configured to grasp the plunger or pull rod to drive the insertion member to perform a retracting movement.

[0026] The insertion system may further include at least one guide sleeve and at least one insertion sleeve guided therein. The term "guide sleeve" as used herein is a broad term and will be given a common and customary meaning for ordinary technicians in the field, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a housing of one or more components, which is constructed to guide the components surrounded by the guide sleeve, specifically at least one movement of the insertion sleeve and the insertion component retractor. The guide sleeve may completely or partially surround the insertion component retractor, the insertion component, and the insertion sleeve. The guide sleeve may be partially surrounded by the housing of the insertion system. The guide sleeve may be substantially rotationally symmetrical, specifically according to the symmetry of the housing of the insertion system. For example, in the case where the housing may have an axial rotational symmetry about an axis such as a cylindrical axis or an extended axis, the guide sleeve may have a similar axial rotational symmetry. The guide sleeve may be movable relative to the housing of the insertion system. For example, when the insertion system is used, the guide sleeve may be constructed to slide into the cover of the insertion system. When the insertion system is used, the guide sleeve, in particular the proximal end of the guide sleeve, can contact the skin of the user. As used herein, the term "insertion sleeve" is a broad term and is given its common and customary meaning to those of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, an element constructed to at least partially surround the insertion component retractor. The insertion sleeve itself may be completely or partially surrounded by the guide sleeve and / or by the housing of the insertion system. The insertion sleeve may be substantially rotationally symmetrical, specifically according to the symmetry of the housing and the guide sleeve. For example, the housing and the guide sleeve may have axial rotational symmetry about an axis such as a cylindrical axis or an extended axis, and the insertion sleeve may have similar axial rotational symmetry. The interlocking and / or connection of one or more of the elements of the insertion system, such as the guide sleeve, the insertion sleeve, the insertion component retractor, and the insertion component, may be performed by using one or more of hooks, rods, plungers, wings, grooves, clamps, fingers, etc.

[0027] As mentioned above, the insertion system may include a housing. As used herein, the term "housing" is a broad term, and is given its common and customary meaning for those of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, an element or component having at least one interior space and at least one wall, the at least one wall completely or partially surrounding the at least one interior space and providing protection for the interior space, such as one or more of mechanical protection and protection for environmental impacts (such as one or more of moisture, oxygen and microbial contamination). The housing may generally be suitable for completely or partially surrounding and / or receiving one or more elements, so as to provide one or more of the following items: mechanical protection, mechanical stability, environmental protection for moisture and / or ambient atmosphere, shielding for electromagnetic impacts, etc. The housing may also provide a basis for attaching and / or maintaining one or more other components or elements. The housing may include an internal structure, which is constructed to hold together the components of the insertion system, such as at least one latch element. The latch element may interlock the housing with at least one of the other components, such as a guide sleeve and / or an insertion sleeve. The housing may be attached to the insertion sleeve during production. In particular, the housing may be attached to the insertion sleeve by a snap connection. However, additionally or alternatively, the housing may be attached to the insertion sleeve by bonding, welding, screwing, thermal stacking or any other method known to those skilled in the art.

[0028] The housing may include at least two parts. The housing may include an insertion cover. The term "insertion cap" as used herein is a broad term and is given its common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a portion of a housing that is constructed to trigger, start, and perform one or more of the insertion movements. The insertion cover may be arranged at the upper portion of the housing, wherein the "upper" may refer to the situation in which the insertion system is directed toward use. The insertion movement may include movement of the insertion cover from its initial position to its insertion position together with the insertion component retractor and the insertion sleeve. The insertion movement may be initialized by the action of the user. Specifically, the action of the user may be or may include applying force to the insertion cover by the user, such as by manually pressing down and / or pushing the insertion cover, specifically in the direction toward the user's skin. The insertion system may be a mechanical insertion device that may be operated by hand, preferably without the need for an electrical or electromechanical actuator. However, other embodiments are also feasible.

[0029] The housing may further include a protective cap. The protective cap may be arranged at the lower portion of the housing, wherein the "lower" may refer to the situation in which the insertion system is directed toward the direction of use. The term "protective cap" as used herein is a broad term and is given its common and customary meaning for those of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a portion of a housing that is constructed to protect a medical device and / or an insertion component before use, such as during storage, supply, sale, etc. The protective cap may be constructed to provide an ingenious closure of the insertion system. The protective cap may be detachable from the insertion system by at least one twisting movement. The removal of the protective cap may include at least partially exposing the guide sleeve and the insertion component for use in the insertion system.

[0030] The insertion system includes at least one screw coupling configured to couple at least one first element and at least one second element of the insertion system. The screw coupling is configured such that the first element and the second element are assembled without rotational movement. The screw coupling includes

[0031] - at least one radially flexible part configured to move and / or deform radially when assembling the first element and the second element, wherein the radially flexible part is part of the first element or the second element;

[0032] - an elastic member configured for applying a force to the screw coupling in an axial direction, wherein the elastic member is preloadable in the axial direction during assembly of the insertion system.

[0033] As used herein, the terms "first element" and "second element" are broad terms and are to be given the ordinary and customary meanings to those of ordinary skill in the art and are not limited to special or customized meanings. The terms may specifically refer to, but are not limited to, two components of an insertion system. The terms "first" and "second" elements are used only as names and in particular do not provide any information about the order and / or about whether, for example, other elements are present.

[0034] As used herein, the term "coupling" is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the mechanical connection of two or more elements. As used herein, the term "screw coupling" is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the mechanical connection of two or more elements using at least one thread. As used herein, the term "mechanical connection" is a broad term and will be given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, connecting two or more components by a mechanical retaining force. As an example, a mechanical connection may be or may include at least one of a form fit and / or a force fit connection.

[0035] The term "thread" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, at least one structure that includes at least a dent that runs continuously, such as spirally, at least in one or more sections in a cylindrical inner wall or outer wall. Each of the first element and the second element may include a thread. The first element and the second element may form a pair of matching threads, such as an external thread and an internal thread. The pair of threads of the first element and the second element may be marked as mating threads. One of the threads of the first element and the second element may be an external thread, and the other may be an internal thread. The term "male" thread as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, a thread on an outer surface. The term "female" thread as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, threads on an interior surface.

[0036] A spiral coupling, for example, one of the threads of the first element and the second element may include at least one stopper, which is configured to at least partially block the relative axial movement of the first element and the second element. The term "stopper" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, the defined endpoints of the path of motion of the relative movement of the first element and the second element. The stopper may be formed by an element of any shape, such as a physical obstacle. The stopper may be a component of one or both of the first element and the second element or other elements of the insertion system. At the stopper, the first element may collide with the second element, and / or one of the first element and the second element may collide with other elements of the insertion system. The term "at least partially blocking" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or customary meaning. The term may specifically refer to, but is not limited to, blocking the relative axial movement of the first element and the second element, so that there is still an axial gap.

[0037] The spiral coupling is constructed so that the first element and the second element are assembled without rotational movement. The term "assembled" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a connection state, also referred to as a fit. The term "rotational movement" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, movement along at least one axis of rotation. The first element and the second element may have at least two degrees of freedom relative to each other, such as axial movement and rotational movement. The axial direction may be defined by an axis extending (e.g., of the first element and the second element) of the insertion system. Movement in the axial direction may be indicated as axial movement, and may also be indicated as translation. Movement that changes radial orientation around the axis of rotation may be indicated as rotational movement or torsion. The axis of rotation may, for example, be an axis extension. As used herein, the term "without rotational movement" is a broad term and is given the ordinary and customary meaning to one of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, the fact that the first element and the second element are assembled only by axial movement, such as the first element and the second element are not twisted relative to each other. The first element and the second element may be assembled by strictly axial movement.

[0038] The spiral connector can be configured to connect the first element and the second element by pressing one of the first element and the second element over the other of the first element and the second element. The term "pressing over" as used herein is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term specifically may refer to, but is not limited to, applying a force in an axial direction so that one of the first element and the second element slides over the other. After pressing one of the first element and the second element over the other, during assembly, there may be an axial gap so that the first element and the second element can move relative to each other in the axial direction. The axial gap can be, for example, a few tenths of a millimeter.

[0039] As described above, the spiral coupling includes at least one radially flexible part, which is configured to move and / or deform radially when assembling the first element and the second element. The term "flexible" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, elastic properties. The term "radially flexible" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the fact that a radially flexible part is configured to move and / or deform at right angles to the axis of rotation. The radially flexible part is a part of the first element or the second element. The radially flexible part may be configured to retreat, such as by moving and / or deforming in the direction of a radial force applied by one of the first element and the second element that does not include the radially flexible part. The retreat may be at least partially based on Hooke's law. For example, a radially flexible part may be configured to move radially inward when pressed inward. For example, a radially flexible part may be configured to move radially outward when pressed outward. A flexible feature may include a lower stiffness than surrounding components, for example due to its geometry and / or material properties.

[0040] The first element and the second element can be interlocked via grooves and protrusions of the mating threads of the first element and the second element. For example, one of the first element and the second element can include a radially flexible part. The other of the first element and the second element can include at least one groove for interlocking with at least one element of the radially flexible part, and at least one protrusion element configured to apply radial force on the radially flexible part when the first element and the second element are connected. The groove and protrusion elements can be elements of mating threads. The groove and protrusion elements can be formed by indentations that run continuously, such as spirally, at least in one or more sections in a cylindrical inner wall or outer wall. The radially flexible part can be configured to move and / or deform radially when pressed on the threads of the first element and the second element. The radially flexible part can include at least one inclined surface that is configured to slide on the protrusion element. The inclined surface can support sliding and minimize the force required for pressing on. For example, the spiral connector can include a snap closure. As used herein, the term "snap closure" is a broad term and is given the ordinary and customary meaning to those of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any closure that is configured for engagement via a snap or clip mechanism.

[0041] The spiral coupling can be configured to detachably couple the first element and the second element. As used herein, the term "detachably coupled (detachably coupling)" is a broad term, and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term specifically may refer to, but is not limited to, the fact that the first element and the second element can return to a disconnected state from a mating state. The spiral coupling can be closed and released at will. For example, the spiral coupling can be released by manual action without the use of any tools. For example, the first element and the second element can be disconnected by twisting one of the first element and the second element. The spiral coupling can be detachable only when at least one of the first element and the second element is deformed and / or damaged. The spiral coupling can be configured to provide an ingenious closure of the insertion system.

[0042] As described above, the spiral coupling further includes an elastic member, which is configured to apply force to the spiral coupling in an axial direction. As used herein, the term "elastic means" is a broad term, and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term specifically may refer to, but is not limited to, a combination of one or more elements with elastic properties and / or one or more elements configured to provide an elastic function. According to Hooke's law, the elastic member may have linear elastic properties. For example, the elastic member may include at least one spring element, such as a coil spring or a leaf spring, and / or at least one elastic arm, such as an elastic plastic arm.

[0043] As used herein, the term "applying a force in an axial direction" is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, at least one process of clamping and / or tensioning a first element and a second element relative to each other. The force in the axial direction may act on the first element and the second element so that the two parts are clamped and / or tensioned to each other. For example, as will be outlined in more detail below, the elastic member may be preloadable in the axial direction during the assembly of the insertion system. For example, the elastic member may include at least one spring element and / or at least one elastic arm, and the spring element and / or at least one elastic arm may be preloaded by compression or extension to a distance from their respective equilibrium lengths. By releasing the load on the elastic member, the elastic member may apply (opposite) force on the first element and the second element in the axial direction. For example, the elastic member may be pushed back to its equilibrium length, such as according to Hooke's law in the case of linear elastic properties. In this case, the force applied by the elastic member in the axial direction may be linearly proportional to the distance from its equilibrium length. The spiral coupling may include at least one stopper configured to block further movement in the axial direction. The spring tension of the elastic member may be configured to prevent (re)movement in the opposite axial direction. However, other embodiments are also possible. For example, the elastic member may have elastic properties that are different from linear elastic properties. For example, the release of the load may include incomplete release of the load, for example reaching a defined threshold.

[0044] During the assembly of the insertion system, the elastic member is preloadable in the axial direction. As used herein, the term "preloadable" is a broad term and is given a common and customary meaning for those of ordinary skill in the art, and is not limited to a special or custom meaning. The term specifically may refer to, but is not limited to, the fact that at least one load is applied to the elastic member due to assembly, such as the connection of the first element and the second element. The load can be applied directly and / or indirectly to the elastic member. For example, in the case of applying a load directly to the elastic member, a member for preloading (means to preload) can contact the elastic member. For example, in the case of indirectly applying a load, the load can be applied to other elements, which in turn act on the elastic member. For example, during the assembly of the insertion system, the elastic member can be deformed in the axial direction, such as by compression, so as to preload the elastic member. The load for preloading the elastic member can be applied by an external force on the elastic member, such as by applying a member for preloading. As used herein, the term "external force" is a broad term and is given a common and customary meaning for those of ordinary skill in the art, and is not limited to a special or custom meaning. The term specifically refers to, but is not limited to, a force applied at least partially from outside the insertion system. During assembly, deformation can be generated by applying an external force, and the coupling of the first element and the second element can be allowed. The elastic member can be configured to drive at least one axial and relative movement of the first element and the second element when the external force on the elastic member is withdrawn, so that the first element and the second element are axially positioned and rotated relative to each other. Therefore, after the assembly of the first element and the second element, the force acting on the elastic member is reduced, and the deformation is reduced thereby, thereby removing the axial and radial clearances between the first element and the second element. The withdrawal of the external force can include at least partially reducing the force. For example, the external force can be reduced so that it is still greater than zero. The spiral coupling can allow the inaccuracy of the relative rotational orientation of the first element and the second element to be avoided in the thread clearance and the first element and the second element. The spiral coupling can realize the assembly of two sleeves, for example, without generating rotational movement due to the radial flexibility of at least a part of the spiral coupling, thereby obtaining a high precision of the relative rotational orientation. After assembly, by applying a force in the axial direction applied by the elastic member, the clearance in the axial direction is removed, and the axial movement in the spiral coupling can be avoided. The screw coupling allows a defined rotational and axial position of the screw coupling to be achieved simultaneously.

[0045] The housing may include at least one opening. For example, the opening may be included by the insertion cover. The term "opening" as used herein is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, an element of a housing configured to provide a passage from the outside of the insertion system to the elastic member. The elastic member may be preloadable via an opening of the housing. The opening may be configured so that an external force may be applied to the elastic member in an axial direction via a member for preloading. For example, the member for preloading includes at least one pin. For example, the opening may be a hole. The hole may have a shape that matches the shape of the pin, such as a circular hole.

[0046] For example, the first element is a guide sleeve and the second element is a protective cover of the housing. The elastic member can be coupled to the guide sleeve. The elastic member can be positioned on the inner surface of the insertion cover. The opening can be included by the insertion cover. Additionally or alternatively, the elastic member can be embodied as part of the protective cover. The opening can be included by the protective cover.

[0047] In another aspect of the present invention, a kit is disclosed, comprising at least one insertion system according to any of the embodiments disclosed above and / or according to any of the embodiments disclosed in further detail below. For possible definitions and options, reference may be made to the present disclosure of the insertion system according to the present invention. The term "kit" as used herein is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term specifically may refer to, but is not limited to, a combination of at least two items, which, as an example, may be provided in combination in a package, which may interact to achieve at least one common purpose.

[0048] The kit further comprises means for preloading the elastic member during assembly. For example, the means for preloading comprises at least one pin.

[0049] In another aspect of the invention, a method is disclosed for assembling a first element and a second element of an insertion system using a kit according to any of the embodiments disclosed above and / or according to any of the embodiments disclosed in further detail below. Therefore, for possible definitions and options, reference may be made to the present disclosure of the insertion system and the kit according to the invention. The method comprises the following steps, which steps may specifically be performed in a given order. The method may include other method steps that are not listed.

[0050] The method comprises the following steps:

[0051] a) applying an external force on the elastic member using a member for preloading, wherein the external force acts in an axial direction;

[0052] b) assembling the first element and the second element by strictly axial movement, wherein the assembling comprises interlocking the first element and the second element by using at least one radially flexible part;

[0053] c) Remove the external force on the elastic member.

[0054] To summarize and without excluding other possible embodiments, the following embodiments may be envisaged:

[0055] Embodiment 1. An insertion system comprising at least one spiral connector, the at least one spiral connector

[0056] The coupling is configured to couple at least one first element and at least one second element of the insertion system, wherein the spiral coupling is configured such that the first element and the second element are assembled without rotational movement, wherein the spiral coupling comprises

[0057] - at least one radially flexible part configured to move and / or deform radially when assembling the first element and the second element, wherein the radially flexible part is part of the first element or the second element;

[0058] - an elastic member configured for applying a force to the screw coupling in an axial direction, wherein the elastic member is preloadable in the axial direction during assembly of the insertion system.

[0059] Embodiment 2. An insertion system according to the preceding embodiment, wherein the elastic member comprises at least one

[0060] A spring element and / or at least one resilient arm.

[0061] Embodiment 3. An insertion system according to any one of the preceding embodiments, wherein the insertion system comprises

[0062] A housing, wherein the housing includes at least one opening, wherein the resilient member is preloadable via the opening of the housing.

[0063] Embodiment 4. An insertion system according to the preceding embodiment, wherein the opening is constructed so that

[0064] An external force is applied to the elastic member in the axial direction by the member for preloading.

[0065] Embodiment 5. An insertion system according to any one of the preceding embodiments, wherein the spiral connector is

[0066] The device is configured to prevent axial movement of the first element and the second element.

[0067] Embodiment 6. An insertion system according to any one of the preceding embodiments, wherein the elastic member is constructed

[0068] The invention is configured to drive at least one axial and relative movement of the first element and the second element when the external force on the elastic member is withdrawn, so that the first element and the second element are axially positioned and rotated relative to each other.

[0069] Embodiment 7. An insertion system according to any one of the preceding embodiments, wherein the insertion system comprises

[0070] A housing, wherein the first element is a guide sleeve and the second element is a protective cover of the housing, wherein the housing comprises an insertion cover.

[0071] Embodiment 8. An insertion system according to the preceding embodiment, wherein the housing comprises at least one opening

[0072] an opening, wherein the resilient member is preloadable via the opening, wherein the housing includes an insertion cover and the opening is included by the insertion cover, wherein the resilient member is coupled to the guide sleeve, wherein

[0073] The elastic member is positioned on the inner surface of the insertion cover.

[0074] Embodiment 9. An insertion system according to any one of the two preceding embodiments, wherein the elastic member

[0075] The embodiment is a part of a protective cover, wherein the opening is comprised by the protective cover.

[0076] Embodiment 10. An insertion system according to any one of the preceding embodiments, wherein the insertion system is constructed

[0077] The invention is configured for inserting at least one medical device into a body tissue of a user, 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 the user, and an infusion cannula.

[0078] Embodiment 11. An insertion system according to any of the preceding embodiments, wherein the first element and the second element

[0079] Each of the two elements includes a thread, wherein the spiral connector is configured to connect the first element and the second element by pressing one of the first element and the second element over the other of the first element and the second element, and wherein the radially flexible part is configured to radially move and / or deform when pressed over the threads of the first element and the second element.

[0080] Embodiment 12. An insertion system according to any one of the preceding embodiments, wherein the first element and the second element

[0081] One of the two elements includes a radially flexible part, wherein the other of the first element and the second element includes: at least one groove, which is used to interlock with at least one element of the radially flexible part; and at least one protrusion element, which is constructed to exert a radial force on the radially flexible part when the first element and the second element are connected.

[0082] Embodiment 13. An insertion system according to the preceding embodiment, wherein the radially flexible part comprises at least

[0083] An inclined surface is configured to slide over the protruding element.

[0084] Embodiment 14. The insertion system of any of the preceding embodiments, wherein the spiral connector comprises at least one stop configured to at least partially block relative axial movement of the first element and the second element.

[0085] Embodiment 15. An insertion system according to any of the preceding embodiments, wherein the spiral connector is

[0086] The first element and the second element are configured to be detachably coupled.

[0087] Embodiment 16. A kit comprising at least one plug according to any one of the preceding embodiments.

[0088] An insertion system and means for preloading the elastic member during assembly.

[0089] Embodiment 17. A kit according to the preceding embodiment, wherein the means for preloading comprises at least

[0090] A pin.

[0091] Embodiment 18. A method for assembling an insert using a kit according to any one of the preceding embodiments.

[0092] A method for a first element and a second element of a system, wherein the method comprises the following steps:

[0093] a) applying an external force on the elastic member using a member for preloading, wherein the external force acts in an axial direction;

[0094] b) assembling the first element and the second element by strictly axial movement, wherein the assembling comprises interlocking the first element and the second element by using at least one radially flexible part;

[0095] c) Remove the external force on the elastic member. BRIEF DESCRIPTION OF THE DRAWINGS

[0096] Other optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Wherein, as will be appreciated by those skilled in the art, each optional feature can be implemented in a separate manner and in any arbitrarily feasible combination. The scope of the present invention is not limited by the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. Wherein, the same reference numerals in these drawings refer to the same or functionally equivalent elements.

[0097] In the attached picture:

[0098] Figures 1A to 1E A method for assembling a first component and a second component of an insertion system is shown;

[0099] Figure 2 An embodiment of an insertion system having a coupled first and second element is shown;

[0100] Figures 3A to 3D Shown without protective cover Figure 2 Cross-sectional view of the assembled insertion system

[0101] ( Figure 3A ); A top view of an insertion cannula with an insertion component retractor and an insertion cover ( Figure 3B ); perspective view of an insertion cannula with an insertion component retractor and an insertion cover ( Figure 3C ); perspective view of the protective cover ( Figure 3D );and Figure 4 Shows Figure 2 A cross-sectional view of a detail of the assembled insertion system. DETAILED DESCRIPTION

[0102] Figures 1A to 1E An illustrative embodiment of a method for assembling a first component 110 and a second component 112 of an insertion system 114 using a kit 116 is shown in accordance with the present invention.

[0103] Figure 1A The insertion system 114 is shown prior to assembly. The insertion system 114 includes at least one screw coupling 118 configured to couple the first element 110 and the second element 112.

[0104] The spiral coupling 118 includes at least one radially flexible part 120 configured to move and / or deform radially when the first element 110 and the second element 112 are assembled. The radially flexible part is a part of the first element 110 or the second element 112. The spiral coupling 118 includes an elastic member 122 configured to apply a force in an axial direction 124 to the spiral coupling 118. During assembly of the insertion system 114, the elastic member 122 is preloadable in the axial direction 124.

[0105] Each of the first element 110 and the second element 112 may include a thread 126. The first element 110 and the second element 112 may form a pair of matching threads 126, such as an external thread and an internal thread. In this embodiment, the first element 110 may be an external thread and the second element 112 may be an internal thread.

[0106] The elastic member 122 may include one or more elements having elastic properties and / or a combination of one or more elements configured to provide an elastic function. According to Hooke's law, the elastic member 122 may have linear elastic properties. For example, the elastic member 122 may include at least one spring element, such as Figures 1A to 1E The coil spring shown. Before the assembly of the first element 110 and the second element 112, the elastic member 122 can be released and have a minimum preload. The elastic member can be arranged between the stopper 128 and the inner portion of the thread 126 of the first element 110.

[0107] During assembly of the insertion system 114 , the resilient member 122 may be preloadable in the axial direction 124 . Figure 1B The elastic member is shown to be preloaded during assembly. Specifically, Figure 1B Step a) of the method is shown, which includes applying an external force on the elastic member 122 using the member for preloading 134, wherein the external force acts in the axial direction 124. For example, during assembly of the insertion system 114, the elastic member 122 can be deformed in the axial direction 124, for example, compressed, thereby preloading the elastic member 122. The load for preloading the elastic member 122 can be applied by an external force acting on the elastic member 122, for example, by using the member for preloading 134. Figure 1B As shown, the insertion system 114 may include a housing 130. The housing 130 may include at least one opening 132. The opening 132 may be configured to provide access to the elastic member 122 from the outside of the insertion system 114. The elastic member 122 may be preloadable via the opening 132 of the housing 130. The opening 132 may be configured so that an external force may be applied to the elastic member 122 in the axial direction 124 via a member 134 for preloading. For example, the member 134 for preloading includes at least one pin. For example, the opening 132 may be a hole. The hole may have a shape that matches the shape of the pin, such as a circular hole. In this position, the tension on the elastic member 122 is at its highest position. In this state, the first element 110 and the second element 112 may be coupled.

[0108] The spiral coupling 118 is configured so that the first element 110 and the second element 112 are assembled without rotational movement. The first element 110 and the second element 112 can be assembled only by axial movement, such as without twisting of the first element 110 and the second element 112 relative to each other. The first element 110 and the second element 112 can be assembled by strictly axial movement.

[0109] Figure 1C The assembly of the first element 110 and the second element 112 by strictly axial movement is shown, step b). During the preloading of the elastic member 122, the second element 112 can be pressed above the first element 110. Pressing above includes applying a force in the axial direction 124 so that one of the first element 110 and the second element 114 slides over the other. As described above, the spiral coupling 118 includes at least one radially flexible part 120, which is configured to move and / or deform radially when the first element 110 and the second element 112 are assembled. The radially flexible part 120 can be configured to move and / or deform at right angles to the axis of rotation. In this embodiment, the radially flexible part 120 is part of the first element 110. The radially flexible part 120 can be configured to retreat, such as by movement and / or deformation in the direction of the radial force applied by the second element 112. The retreat can be at least partially based on Hooke's law. For example, the radially flexible part 120 can be configured to move radially inward when pressed inward.

[0110] like Figure 1D As shown, after being pressed on, during assembly, there may be an axial gap 136 so that the first element 110 and the second element 112 can move relative to each other in the axial direction 124. The axial gap 136 may be, for example, a few tenths of a millimeter. The stop 128 may be configured to at least partially block the relative axial movement of the first element 110 and the second element 122. The stop 128 may be formed by an element of any shape, such as a physical barrier. The stop 128 may be a component of one or both of the first element 110 and the second element 112.

[0111] Figure 1EThe assembled insertion system 114 is shown. The elastic member 122 can be configured to drive at least one axial and relative movement of the first element 110 and the second element 112 when the external force on the elastic member 122 is withdrawn (step c), so that the first element 110 and the second element 112 are axially positioned and rotated relative to each other. Therefore, after the assembly of the first element 110 and the second element 112, the force acting on the elastic member 122 is reduced, and the deformation is reduced thereby, thereby removing the axial and radial clearance between the first element 110 and the second element 112. The withdrawal of the external force can include at least partially reducing the force. For example, the external force can be reduced so that it is still greater than zero. The spiral coupling 118 can allow the avoidance of thread clearance and the inaccuracy of the relative rotational orientation of the first element 110 and the second element 112. The spiral coupling 118 can realize, for example, the assembly of two sleeves without generating a rotational movement due to the radial flexibility of at least a portion of the spiral coupling 118, thereby obtaining a high accuracy of the relative rotational orientation. After assembly, the axial clearance is removed by applying the axial force applied by the elastic member 122, and the axial movement in the spiral coupling 118 can be avoided. The spiral coupling 118 can achieve the defined rotation and axial position of the spiral coupling 118 at the same time.

[0112] The spiral coupling 118 can be configured to detachably couple the first element and the second element. The spiral coupling 118 can be closed and released at will. For example, the spiral coupling 118 can be released by manual action without using any tools. For example, the first element 110 and the second element 112 can be disconnected by twisting one of the first element 110 and the second element 112. The spiral coupling 118 can be detachable only when at least one of the first element 110 and the second element 112 is deformed and / or damaged. The spiral coupling 118 can be configured to provide an ingenious closure of the insertion system 114.

[0113] Figure 2 An embodiment of an insertion system 114 is shown having a coupled first element 110 (not visible here) and a second element 112. The second element 112 may be a protective cover 140 of the housing 130. Figure 3D 140. The housing 130 further includes an insert cover 142. The insert cover 142 may include openings 132, such as two circular openings, such as Figure 2 shown.

[0114] Figure 3A The protective cover 140 is shown. Figure 21. A cross-sectional view of an assembled insertion system 114. In this embodiment, the first component 110 is a guide sleeve 138. The insertion system 114 may include at least one insertion component retractor 144. The insertion system 114 may further include at least one insertion sleeve 146 guided in the guide sleeve 138. Figure 3C As shown in FIG. 1 , without the protective cover 140, downward movement of the insertion sleeve 146 may be limited by the wings 152 of the guide sleeve 138, which extend inwardly from the guide sleeve 138 into the groove of the insertion sleeve 146. The insertion system 114 further includes a resilient member 122, such as Figure 3B 146. The resilient member 122 may be coupled to the guide sleeve 138. At least a portion of the resilient member 122 may rest on a portion of the insertion sleeve 146, as highlighted by the circle surrounding the arm of the resilient member 122. The resilient member 122 may include at least one connecting rod 150. The connecting rod 150 may couple the guide sleeve 138 and the resilient member 122. The arm portion of the resilient member 122 may be configured to block upward movement of the insertion sleeve 146 relative to the guide sleeve 138.

[0115] The elastic member 122 may be preloadable by using a member 134 for preloading, such as at least one pin, via the opening 132 of the housing 130. The member 134 for preloading may be pushed via the opening 132 in the housing 130 until they reach the connecting rod 150. During assembly, the elastic member 122 may be preloaded by an external force. The external force may be applied to the connecting rod 150 via the member 134 for preloading. As a result, the guide sleeve 138 and the connecting rod 150 move downward. Due to the downward movement of the guide sleeve 138, the arm of the elastic member 122 may be pushed upward by the insertion sleeve 146. In this state, the tension of the arm may be at the highest point.

[0116] The insertion system 114 can be prepared in this state so that the second element 112 can be assembled, for example by pressing one of the guide sleeve 138 and the protective cover 140 onto the other of the guide sleeve 138 and the protective cover 140. When the guide sleeve 138 and the protective cover 140 are assembled to their final position, there may be a gap 136 relative to each other. In the assembled state, i.e. with the protective cover 140, such as Figure 4 As shown, the downward movement of the insertion cover 142 and the upward movement of the protection cover 140 can be prevented by the stopper 154 (at Figure 4 The insert cover 142 and the protective cover 140 collide with each other at the stopper. Figure 4 As can be seen in FIG. 1 , the thread is formed by a protrusion from the outer wall of the guide sleeve 138 and a corresponding groove in the inner wall of the protective cover 140. The thread 126 is formed by a protrusion from the outer wall of the guide sleeve 138 and a corresponding groove in the inner wall of the protective cover 140. Figure 4 Highlighted with a circle.

[0117] The external force can then be reduced, for example by removing the member 134 for preloading. Due to the tension of the arms of the elastic member 122 and the guide sleeve 138, the reduction of the external force can trigger the insertion sleeve 146 to push downward and the connecting rod 150 to move upward. Thereby, the guide sleeve 138 and the protective cover 140 can move relative to each other so that the axial gap 136 is compensated. In this position, the first element 110 and the second element 112 are axially positioned and are rotational relative to each other.

[0118] Reference numerals list

[0119] 110 First Element

[0120] 112 Second Element

[0121] 114 Insertion system

[0122] 116 Kit

[0123] 118 Screw connector

[0124] 120 Radial flexible parts

[0125] 122 elastic member

[0126] 124 Axial direction

[0127] 126 Thread

[0128] 128 Stopper

[0129] 130 Housing

[0130] 132 Opening

[0131] 134 Components for preloading

[0132] 136 Axial clearance

[0133] 138 Guide cannula

[0134] 140 Protective cover

[0135] 142 Insert cover

[0136] 144 Insertion Parts Retractor

[0137] 146 Insertion cannula

[0138] 150 Connecting rod

[0139] 152 Wing

[0140] 154 Stopper

Claims

1. An insertion system (114), comprising at least one spiral coupling (118), the at least one spiral coupling being configured to couple at least one first element (110) and at least one second element (112) of the insertion system (114), wherein the spiral coupling (118) is configured such that the first element (110) and the second element (112) are assembled without rotational movement, wherein the spiral coupling (118) comprises - at least one radially flexible part (120) configured to move and / or deform radially when assembling the first element (110) and the second element (112), wherein the radially flexible part (120) is part of the first element (110) or the second element (112); - an elastic member (122) configured to apply a force to the spiral coupling (118) in an axial direction (124), wherein the elastic member (122) is preloadable in the axial direction (124) during assembly of the insertion system (114).

2. The insertion system (114) according to the preceding claim, wherein the elastic member (122) comprises at least one spring element and / or at least one elastic arm.

3. An insertion system (114) according to any of the preceding claims, wherein the insertion system (114) includes a shell (130), wherein the shell (130) includes at least one opening (132), and wherein the elastic member (122) is preloadable via the opening (132) of the shell (130).

4. The insertion system (114) according to the preceding claim, wherein the opening (132) is constructed so that an external force can be applied to the elastic member (122) in an axial direction via a member (134) for preloading.

5. The insertion system (114) according to any one of the preceding claims, wherein the spiral coupling (118) is configured to prevent axial movement of the first element (110) and the second element (112).

6. An insertion system (114) according to any of the preceding claims, wherein the elastic member (122) is constructed to drive at least one axial and relative movement of the first element (110) and the second element (112) when the external force on the elastic member (122) is withdrawn, so that the first element (110) and the second element (112) are axially positioned and rotated relative to each other.

7. An insertion system (114) according to any of the preceding claims, wherein the insertion system (114) comprises a shell (130), wherein the first element (110) is a guide sleeve (138) and the second element (112) is a protective cover (140) of the shell (130), wherein the shell (130) further comprises an insertion cover (142).

8. An insertion system (114) according to the preceding claim, wherein the housing (130) includes at least one opening (132), wherein the elastic member (122) is preloadable via the opening (132), wherein the opening (132) is included by the insertion cover (142), wherein the elastic member (122) is connected to the guide sleeve (138), and wherein the elastic member (122) is positioned on an inner surface of the insertion cover (142).

9. An insertion system (114) according to any of the preceding claims, wherein the insertion system (114) is constructed for inserting at least one medical device into a user's body tissue, 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 the user's body fluid and an infusion cannula.

10. An insertion system (114) according to any of the preceding claims, wherein each of the first element (110) and the second element (112) includes a thread (126), wherein the spiral connector (118) is constructed to connect the first element (110) and the second element (112) by pressing one of the first element (110) and the second element (112) above the other of the first element (110) and the second element (112), and wherein the radially flexible part (120) is constructed to move and / or deform radially when pressed above the thread (126) of the first element (110) and the second element (112).

11. The insertion system (114) according to any one of the preceding claims, wherein one of the first element (110) and the second element (112) comprises the radially flexible part (120), wherein the other of the first element (110) and the second element (112) include: at least one groove for interlocking with at least one element of the radially flexible part (120); and at least one protruding element configured to exert a radial force on the radially flexible part when the first element (110) and the second element (112) are coupled.

12. The insertion system (114) according to any one of the preceding claims, wherein the spiral coupling (118) include: At least one stopper (128) is configured to at least partially block relative axial movement of the first element (110) and the second element (112).

13. The insertion system (114) according to any one of the preceding claims, wherein the spiral connector (118) is configured to detachably couple the first element (110) and the second element (112).

14. A kit (116) comprising at least one insertion system (114) according to any one of the preceding claims and means (134) for preloading the elastic member (122) during assembly.

15. A method for assembling a first element (110) and a second element (112) of an insertion system (114) using a kit (116) according to the preceding claim, wherein the method The following steps are involved: a) applying an external force on the elastic member (122) using a member (134) for preloading, wherein the external force acts in an axial direction; b) assembling the first element (110) and the second element (112) by strictly axial movement, wherein the assembling comprises interlocking the first element (110) and the second element (112) by using at least one radially flexible part (120); c) withdrawing the external force on the elastic member (122).

Images