Insertion device and method for inserting a medical device - Patent Application 20070122997

Abstract

An insertion device (110) for inserting a medical device (112) into a body tissue of a user is disclosed. The insertion device (110) includes: i) the medical device (112); ii) an insertion piece (118) configured to insert the medical device (112) into the body tissue; iii) an insertion piece retractor (120); iv) a cap (122); v) a guide sleeve (124) having at least one ramp (126); vi) an insertion sleeve (128); and vii) an elastic member (130), wherein the cap (122), the insertion piece retractor (120), and the insertion sleeve (128) are positioned distally relative to the guide sleeve (124) to insert the medical device (112). The cap (122) is movable from its distal position (164) to its proximal position (166), and the ramp (126) of the guide sleeve (124) is configured to twist the insert-retractor (120) relative to the guide sleeve (124) and the insert-retractor sleeve (128) when the cap (122) is moved from its distal position (164) to its proximal position (166), and the cap (122) is movable from its proximal position (166) to its distal position (164), thereby moving the insert-retractor (120) from its proximal position (166) to its distal position (164). Further disclosed is a method for inserting a medical device (112) into body tissue of a user.

Description

[Technical Field]

[0001] The present invention relates to an insertion device and method for inserting a medical device into a user's body tissue. The medical device can be specifically configured to detect at least one analyte in a user's body fluid. The insertion device and method can be applied in the field of continuous monitoring of analytes in a user's body fluid, particularly in the field of home medical care and in the field of specialized medical care such as in hospitals. However, other applications are also feasible. [Background technology]

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

[0003] Generally, systems and corresponding insertion devices for long-term monitoring of analytes in a user's body tissue are known. For example, U.S. Patent No. 7,310,544 discloses a system and method for measuring analytes in a host. More particularly, the invention relates to a system and method for transcutaneous measurement of glucose in a host.

[0004] EP 1624914 discloses a device comprising a housing having a mounting surface adapted for application to the skin of a subject, and a needle having a pointed end adapted to penetrate the skin of the subject, the needle having a first position in which the distal end is retracted within the housing and a second position in which the distal end protrudes relative to the mounting surface. The device further comprises a drive means operable to cause activation and release of the drive means, thereby moving the needle from the first position to the second position. With this configuration, the needle device can be supplied to a user in a non-energized state, with energization occurring when the device is activated by the user, meaning that energy is stored for a period of time ranging from a few seconds to several hours or days.

[0005] Another example of an apparatus for inserting a medical device such as an analyte sensor is known from EP 3 542 712 A1.

[0006] Other insertion devices for drug delivery systems are known. For example, U.S. Patent Application Publication No. 2013 / 245604 describes a system that includes two main components: an automatic injection device containing two medications and a medication module containing at least one medication. The medication module interfaces with the automatic injection device so that a combined dose containing all medications can be delivered through a single dispensing interface of the medication module.

[0007] A sensor may be contacted with a bodily fluid to monitor an analyte in the bodily fluid. Typically, this requires subcutaneous insertion of the sensor. Examples include systems in which the sensor can be connected to an electronics unit upon insertion. These systems may include a sensor base plate into which the sensor is inserted. After insertion of the sensor, the electronics unit may be connected to the base plate and the sensor. The base plate may expose an exposed spot within the covered area, and the sensor may be inserted into the user's skin at the exposed spot. In systems in which the sensor is fixedly connected to the electronics unit, insertion of the sensor may occur simultaneously with attachment of the electronics unit to the user's skin.

[0008] Typically, sensors can be inserted using an inserter, such as a needle. Often, such systems include a mechanism for retracting the inserter after the electronics unit is attached to the user's skin and the sensor is inserted into the user's skin. To minimize the risk of infection, the inserter can be retracted deep within the system's housing. Retraction of the inserter may be mechanically initiated after the inserter's movement into the skin.

[0009] Despite the advantages achieved by the above-described devices, several technical challenges remain. The insertion piece must be retracted near but before the deepest point of the insertion movement. This can cause the insertion piece to retract before the sensor fully penetrates the skin or not at all. The needle can exert a force on the skin where the sensor is to be inserted. The skin can bulge inward under the action of this force. In commonly known devices, the insertion needle is retracted near the end of the insertion movement. Due to the inward bulging of the skin, the sensor may not be fully inserted when the needle begins to rapidly disappear. As a result, the sensor may not be inserted or may be partially inserted. In this case, the sensor must penetrate the user's skin by itself when the insertion piece is retracted. However, sensors can generally be soft and flexible to minimize irritation to the user's skin, and as a result, the sensor may not be able to pierce and advance through the user's skin when the insertion piece is retracted without achieving full insertion. This can result in the sensor not being fully inserted under the user's skin and potentially being bent during insertion. Therefore, the sensor may not be able to perform its function. Summary of the Invention

[0010] It is therefore desirable to provide a method and insertion device that at least partially addresses the above-mentioned technical challenges, particularly an insertion device that allows for safe and user-friendly handling of the insertion device while ensuring reliable insertion of the medical device into the body tissue of a user.

[0011] This problem is addressed by a method and an insertion device for inserting a medical device into a user's body tissue having the features of the independent claims. Advantageous embodiments, which can be realized alone or in any combination, are listed in the dependent claims as well as in the entire specification.

[0012] When used below, the terms "have", "comprise" or "include" or any grammatical variations thereof are used in a non-exclusive manner. These terms may therefore refer both to the situation in which, in addition to the features introduced by these terms, no further features are present in the entity described in this context, and to the situation in which one or more additional features are present. For example, the expressions "A has B", "A comprises B" and "A includes B" may both refer to the situation in which, apart from B, no other elements are present in A (i.e., the situation in which A consists solely and exclusively of B), and to the situation in which, apart from B, one or more further elements are present in entity A, such as element C, elements C and D, and further elements.

[0013] Furthermore, 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 one or more times are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may be present one or more than one time.

[0014] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "particularly," "more particularly," or similar terms are used in conjunction with any feature without limiting the possibility of substitution. Therefore, features introduced by these terms are optional features and are not intended to constrain the scope of the claims in any way. The present invention may also be implemented by using alternative features, as recognized by those skilled in the art. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features without any limitation regarding alternative embodiments of the invention, without any limitation regarding the scope of the invention, and without any limitation regarding the possibility of combining the feature introduced in such a way with other optional or non-optional features of the invention.

[0015] In a first aspect of the present invention, an insertion device for inserting a medical device into a body tissue of a user is disclosed.

[0016] The term "medical device," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term may specifically, but not exclusively, refer to any element or article configured for use in the field of medical technology, particularly in the field of medical analysis or medical diagnosis. A medical device may be configured to perform at least one medical function and / or to be used in at least one medical process, such as one or more of a therapeutic process, a diagnostic process, or another medical process.

[0017] For example, the medical device can be or include at least one analyte sensor for detecting at least one analyte in a user's bodily fluid, such as a bodily fluid contained in a user's bodily tissue. The analyte sensor can be configured for use in qualitatively and / or quantitatively detecting at least one analyte. As used herein, the term "analyte" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically refer to, but is not limited to, chemical and / or biological substances involved in the metabolism of a user's body. Specifically, the analyte can be a metabolite or a combination of two or more metabolites. By way of example, the analyte can be selected from the group consisting of glucose, lactate, triglycerides, and cholesterol. Additionally, other analytes or combinations of two or more analytes can be detected. The bodily tissue can specifically be or include adipose tissue and / or stroma. However, other types of bodily tissue are also feasible.

[0018] The term "analyte sensor," as used herein, is a broad term and should be given its ordinary and customary meaning to those of skill in the art and should not be limited to any special or customized meaning. The term can 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.

[0019] 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 two-electrode sensor. A two-electrode sensor may include exactly two electrodes, such as a working electrode, and at least one additional electrode, such as a counter electrode, particularly a combined working electrode and counter / reference electrode. The working electrode may include a working electrode pad and, optionally, at least one test chemical disposed thereon. The counter electrode may include a conductive electrode pad. Additionally, 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 during or at a later time to an electronics unit, such as one or more measuring devices adapted to measure current and / or voltage, such as one or more potentiostats. Preferably, the leads are already connected to the electronics unit before insertion of the analyte sensor.

[0020] Specifically, the analyte sensor can be a strip-shaped analyte sensor having a flexible substrate and electrodes disposed thereon. By way of example, the analyte sensor can have an overall 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 overall length of the analyte sensor, meaning the portion of the analyte sensor that is inserted and the portion of the analyte sensor that is connected to the electronics unit. The inserted portion of the analyte sensor is also referred to as the in vivo portion, and the portion of the analyte sensor that is connected to the electronics unit is also referred to as the ex vivo portion. Preferably, the in vivo portion has a length in the range of 3 mm to 12 mm.

[0021] The analyte sensor may further comprise a biocompatible cover, such as a biocompatible membrane, that completely or partially covers the analyte sensor and prevents migration of test chemicals into body tissues while allowing diffusion of body fluids and / or analyte to the electrode.

[0022] Other embodiments of the electrochemical analyte sensor may be possible, such as a three-electrode sensor, for example, a three-electrode sensor may include a reference electrode in addition to the working and counter electrodes.

[0023] In another embodiment, the analyte sensor may be an optical analyte sensor. For example, the analyte sensor may include a flexible light guide with a glucose-sensitive coating on its end and / or a tubular carrier with functional elements on its inner or outer wall. Other embodiments of the analyte sensor may also be possible. Reference may be made to the prior art documents mentioned above for potential embodiments of the analyte sensor.

[0024] For example, the medical device can be or include at least one infusion cannula. As used herein, the term "infusion cannula" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically refer to, but is not limited to, a hollow tube configured to deliver and / or infuse medication into a user's body tissue, particularly to deliver and / or infuse insulin into a user's body tissue.

[0025] The term "user," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. This term specifically relates to a person who intends to monitor analyte levels, such as glucose levels, in the person's bodily tissue and / or deliver medication, such as insulin, into the person's bodily tissue. In embodiments, this term may specifically refer to, but is not limited to, a person using an insertion device. However, in embodiments, a person using an insertion device is different from a user. For example, a medical device may be inserted into the user's bodily tissue by a person different from the user. For example, the user may be a patient suffering from a disease, such as diabetes.

[0026] The term "inserting" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. Specifically, the term can refer to, but is not limited to, one or more actions or processes of percutaneously or subcutaneously implanting and / or positioning a medical device within a user's bodily tissue. A medical device, such as an analyte sensor, can be fully or partially inserted into the bodily tissue. Insertion of the medical device can be performed by using an insertion device. After insertion, the medical device, or at least a portion of the medical device, can remain within the user's bodily tissue for a predetermined period of time, such as several hours, specifically one or more days, more specifically up to one week, and even more specifically up to two weeks or more. The medical device can be configured to continuously monitor and / or detect an analyte in the user's bodily fluid.

[0027] The term "insertion device," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term may refer particularly, but not exclusively, to a device configured to insert a medical device into body tissue. The insertion device may be configured to insert the medical device percutaneously or subcutaneously into body tissue, for example, by making an incision or puncture in a user's skin and transferring the medical device completely or partially into the body tissue.

[0028] The insertion device i) a medical device; ii) an insertion piece configured to insert the medical device into body tissue; iii) an insert retractor; and iv) a cap; and v) a guide sleeve with at least one ramp; vi) an insertion sleeve; vii) Elastic members and Equipped with.

[0029] To insert the medical device, the cap, insert retractor, and insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position. A ramp on the guide sleeve is configured to twist the insert retractor relative to the guide sleeve and insertion sleeve when the cap moves from its distal position to its proximal position. The cap is movable from its proximal position to its distal position, which moves the insert retractor from its proximal position to its distal position.

[0030] The term "insertion element" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term may specifically, but not limited to, refer to any element that can be at least partially insertable into bodily tissue, particularly for delivering or transporting additional elements. The insertion element may be configured to support the insertion of a medical device. The insertion element may include a tip or sharp end for inserting the medical device into bodily tissue. The insertion element may be or include an insertion cannula or an insertion needle. The term "insertion cannula" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term may specifically, but not limited to, refer to a hollow needle that may be at least partially slotted. A medical device can be received within the insertion cannula, such as within the lumen of the insertion cannula. The term "insertion needle" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, compact needles, specifically needles that do not include a slot or hollow portion. The medical device can be received on the exterior surface of the insertion needle.

[0031] After insertion, the medical device can remain in the user's body tissue. However, the insert can be retracted from the user's body tissue into the insertion device after inserting the medical device. To retract the insert, the insertion device can include an insert retractor.

[0032] The term "insertion piece retractor" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically refer to, but is not limited to, at least one element of an insertion device configured to retract an insertion piece. The insertion piece retractor can be configured to suspend the insertion piece during an insertion movement and to withdraw it from the user's skin during a retraction movement.

[0033] The engagement between the insert retractor and the insert may be loose. The engagement between the insert retractor and the insert may be established during the manufacturing process. The insert retractor may include at least one finger, gripper, hook, pliers, etc. configured to retract the insert. The finger, gripper, hook, pliers, etc. may be disposed on a proximal end of the insert retractor, and when the insertion device is being used, the proximal end of the insert retractor may face toward the user's body tissue. For example, the insert retractor may include two or more fingers, grippers, hooks, or pliers symmetrically arranged around the insert. For example, the insertion device may include at least one plunger or pull rod connected to the insert. The insert retractor may be connected to the plunger or push rod and / or configured to grip the plunger or pull rod to drive the insert to perform insertion and / or retraction movements.

[0034] The insert retractor may include at least one latch. As used herein, the term "latch" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term may refer to at least one element that protrudes outward from the insert retractor, particularly perpendicular to the insertion direction, but is not limited thereto. The latch may be configured to guide twisting of the insert retractor. The latch may function as a guide wing that interacts with the insertion sleeve, guide sleeve, and / or cap. Torsional guiding may be distinguished from longitudinal guiding, which may be performed by using the cylindrical shape of the insert retractor and its cylindrical counterpart within the insertion sleeve. Specifically, the latch may be configured to slide within a groove in the insertion sleeve to guide twisting of the insert retractor. The latch may be configured to interact with other components of the insertion device, such as a ramp on the guide sleeve. The latch may protrude outward from the exterior of the insert retractor. For example, the insert retractor may form a cylindrical body. The latches can protrude from the sides of the insert retractor, particularly from the cylindrical body. In one embodiment, the insert retractor can include at least two latches. The two latches can be positioned opposite each other on the outside of the insert retractor. The interaction of the latches with other components of the insertion device, specifically with the grooves of the insertion sleeve and / or the ramps of the guide sleeve, is outlined in more detail below.

[0035] The term "cap" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to, but is not limited to, any shaped element configured to completely or partially surround one or more components of an insertion device and / or protect these one or more components from mechanical influences, humidity, and the like. The cap can completely or partially surround and / or enclose one or more additional components, such as an inserter retractor, a guide sleeve, and / or an insertion sleeve. The term "at least partially enclosing," also referred to as "at least partially enclosing," as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to, but is not limited to, embodiments in which the cap completely surrounds one or more additional components of an insertion device and embodiments in which the cap can enclose at least a portion of one or more additional components. For example, the cap of an insertion device can completely surround the insertion sleeve and the inserter retractor. The cap may also at least partially surround the guide sleeve, thus completely covering the guide sleeve except for the proximal end of the guide sleeve. The cap may be positioned to surround and / or encase additional components of the insertion device, and the proximal side of the insertion device may not be at least partially covered by the cap, allowing the user's skin to contact the guide sleeve and move the insertion part from the insertion device. When the cap is in the proximal position, it may be aligned with the proximal end of the guide sleeve. The proximal side may be the side of the insertion device that provides the contact area or region with the user's skin. The distal side may be the side of the insertion device opposite the proximal side.

[0036] The cap may be or may include a rigid cap, such as a rigid cap made from one or more of a plastic material, a metal material, or a cardboard material.

[0037] The cap can be essentially rotationally symmetric, specifically by having axial rotational symmetry about an axis, such as a cylindrical axis or an extension axis. The term "essentially rotationally symmetric" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. This term can specifically refer, but is not limited to, the fact that the cap can be completely rotationally symmetric or can include at least one portion that is rotationally symmetric, while other portions of the cap may exhibit a form that deviates from rotational symmetry. The cap can be designed as a cylinder, a hemisphere, or a dome. The cap can have an internal structure that does not need to be rotationally symmetric. The outer shape of the cap can also be asymmetric, e.g., ergonomically shaped to be held by a user's hand. The internal structure of the cap can be cylindrical or prismatic, corresponding to the structure of the insertion sleeve.

[0038] The cap can further include at least one latch element, particularly on an internal structure of the cap. The latch element can be configured to hold components of the insertion device together. Specifically, the latch element can interlock the cap with at least one of other components, such as the guide sleeve, the insertion sleeve, and the insertion piece retractor, particularly the insertion sleeve.

[0039] The term "guide sleeve," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically refer to, but is not limited to, an enclosure of one or more components configured to guide movement of at least one of the enclosed components. The guide sleeve can completely or partially surround the insert retractor and / or the insert sleeve. The guide sleeve may also be partially surrounded by a cap.

[0040] The guide sleeve may be rotationally symmetrical in nature, particularly according to the symmetry of the cap of the insertion device, particularly the internal structure of the cap of the insertion device. For example, if the cap can have axial rotational symmetry about an axis such as a cylindrical axis or an elongated axis, the guide sleeve can have a similar axial rotational symmetry.

[0041] The guide sleeve may be movable relative to the cap of the insertion device. For example, the guide sleeve may be configured to slide into the cap of the insertion device when the insertion device is in use. The guide sleeve, particularly the proximal end of the guide sleeve, may contact the user's skin when the insertion device is in use.

[0042] The term "ramp" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to, but is not limited to, an element of a guide sleeve having at least one inclined surface. The ramp can be disposed inside the guide sleeve. Specifically, the ramp can be disposed to face a component enclosed by the guide sleeve. The ramp may protrude from the guide sleeve into its interior. The ramp can be or include at least one wedge-shaped ramp. For example, the ramp can include two inclined surfaces that contact each other, with the first inclined surface inclined at an angle relative to the second inclined surface. The ramp can be configured to interact with another component of the insertion device, specifically at least one latch of the insertion piece retractor. The ramp can be received by a component enclosed by the guide sleeve, specifically a groove in the insertion sleeve. In a preferred embodiment, the guide sleeve can include two ramps that protrude from the guide sleeve into its interior. The two ramps of the guide sleeve may in particular be arranged opposite each other inside the guide sleeve.

[0043] The term "insertion sleeve," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term can specifically refer to, but is not limited to, an element configured to at least partially surround an insertion piece retractor. The insertion sleeve itself may be completely or partially surrounded by the guide sleeve and cap of the insertion device.

[0044] The insertion sleeve may be prismatic. The insertion sleeve may be rotationally symmetrical in nature, particularly according to the symmetry of the cap and guide sleeve. For example, the cap and guide sleeve may have axial rotational symmetry about an axis, such as a cylindrical axis or an extension axis, and the insertion sleeve may have similar axial rotational symmetry. The insertion sleeve may be configured to guide an insert-retractor. For example, to guide a cylindrically shaped insert-retractor, the insertion sleeve may have a rotationally symmetric hollow center. The remainder of the insertion sleeve may have an irregular cross-section.

[0045] The insertion sleeve can include at least one receptacle. The receptacle can be located at a distal end of the insertion sleeve. The distal end of the insertion sleeve can refer to a portion of the insertion sleeve that is distal to the user's skin. The receptacle can have at least one opening. The insert and / or insert retractor can extend at least partially through the opening. As used herein, the term "at least partially extending" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to, but is not limited to, the fact that the insert retractor and / or insert can extend completely through the opening of the receptacle, or alternatively, a portion of the insert retractor and / or insert can extend through the opening of the receptacle. Specifically, the insert, particularly a plunger fixedly connected to the insert, can extend at least partially through the opening so that at least a portion of the insert can be positioned below the opening and at least one other portion can be positioned above the opening. "Below the opening" in this context means a proximal position, and "above the opening" in this context means a distal position, with the proximal and distal positions being defined relative to the user's skin when the insertion device is in use. This is defined in more detail below. For example, a plunger fixedly connected to the insertion part may extend through the opening in the insertion sleeve, and other parts of the insertion part, specifically the insertion cannula or needle, may be located below the opening and may be surrounded by the insertion sleeve. The insertion sleeve may include two receptacles, such as one receptacle for an insertion part retractor that may open at the distal end of the insertion sleeve and one additional receptacle for a medical device that may open at the proximal end of the insertion sleeve. The proximal end may be opposite the distal end of the insertion sleeve. In particular, the receptacle for the insertion part retractor may be connected to the additional receptacle for the medical device by an opening.

[0046] The insertion sleeve may include at least one groove. The groove may be configured to guide the latch of the insert retractor in a rotational manner, specifically for twisting the insert retractor. The groove may also be configured to guide the movement of the insert retractor by restricting the direction of movement of the latch. As used herein, the term "groove" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, one or more of a slot, a trench cut, and / or an opening in the insertion sleeve. The groove may be a trench cut into the insertion sleeve such that the groove can only partially cut into the insertion sleeve. Alternatively and / or additionally, the groove may be an opening in the insertion sleeve such that the groove can completely cut through the insertion sleeve. The groove in the insertion sleeve may extend essentially parallel to the extension axis of the insertion sleeve. As used herein, the term "essentially parallel" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term can specifically, but is not limited to, refer to the fact that the groove may extend parallel to the extension axis of the insertion sleeve or may extend in a direction diverging from the extension axis. Specifically, the groove may extend parallel to the extension axis or may change direction from parallel to the extension axis at one or more locations. For example, the groove may include at least one edge and thus diverge from the extension axis at the edge. The edge may be a zigzag edge. Additionally and / or alternatively, the groove may be inclined at an angle relative to the extension axis of the insertion sleeve.

[0047] To insert the medical device, the cap, insert retractor, and insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position. Because the guide sleeve is positioned on the user's skin, the guide sleeve can be considered a fixed or non-moving component of the insertion device. Other components, such as the medical device, insert, insert retractor, insertion sleeve, and cap, can move proximally relative to the user's skin relative to the guide sleeve.

[0048] The term "distal position" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term may specifically, but is not limited to, refer to a position specification indicating a position of an insertion device and / or any portion thereof relative to a user where the insertion piece and / or cap are furthest from the proximal side of the insertion device. Specifically, to insert a medical device, the insertion device can be contacted with a user's skin site. The distal position may refer to a position at a distance relative to a user's skin site. The distal position may be the initial position of the insertion device and / or any portion thereof prior to an insertion movement. Each component of the insertion device may have its own and / or individual distal position. For example, the cap, insertion piece retractor, and insertion sleeve may each have its own and / or individual distal position. Prior to insertion, the cap, insertion piece retractor, and insertion sleeve may be in their distal positions, ready to insert the medical device into a user's body tissue. After insertion, the cap and insert retractor may be returned to their respective distal positions, and the insert may be retracted from the body tissue as the insert retractor may be returned to its distal position.

[0049] The term "proximal position" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. This term may specifically refer to, but is not limited to, a position specification indicating a position of an insertion device and / or any portion thereof relative to a user where the insertion piece and / or cap are closest to the proximal side of the insertion device. Specifically, to insert a medical device, the insertion device can be contacted with a user's skin site. The proximal position may refer to a position that is close to the user's skin site. Each component of the insertion device may have its own and / or individual proximal position. For example, the cap, insertion piece retractor, and insertion sleeve may each have its own and / or individual proximal position. When the cap, insertion piece retractor, and insertion sleeve are in their proximal positions, the medical device can be inserted into the user's body tissue. During insertion of the medical device, the guide sleeve may be in contact with the user's skin site and thus in its proximal position during insertion.

[0050] The movement of the cap together with the insertion piece retractor and insertion sleeve from its distal position to its proximal position may be initiated by a user action. Specifically, the user action may be or include the user applying a force to the cap, such as by manually pressing and / or pushing the cap downward to the proximal position, particularly against the user's skin. The insertion device may be a mechanical insertion device that can preferably be operated by hand, preferably without the need for an electrical or electromechanical actuator. However, other embodiments are possible as well.

[0051] The ramps of the guide sleeve are configured to twist the insert retractor relative to the guide sleeve and insert sleeve when the cap moves from its distal position to its proximal position. The term "twist" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. Specifically, the term can refer to, but is not limited to, rotational movement of the insert retractor about an axis of rotation. The twist can be rotational movement of the insert retractor itself, for example, rotational movement about an axis of rotation coinciding with the axis of extension of the cylindrical body of the insert retractor. Specifically, the insert retractor can be rotationally symmetrical in nature, and the twist can be rotational movement about an axis of symmetry of the insert retractor. The twist can be an angle of less than 90°, specifically less than 45°, and more specifically less than 15°. Other embodiments are possible in which the twist can be greater than about 90°, or even greater than 180°.

[0052] During insertion, movement of the insert retractor from its proximal position to its distal position can be prevented by an internal structure of the cap and a force applied to the cap by the user. The internal structure can be or include a stop and / or blocking element configured to receive the latch of the insert retractor and prevent movement of the insert retractor from its proximal position to its distal position during insertion, particularly by blocking movement of the latch. During insertion, the components of the insertion device move toward each other. When closed before the insert retractor reaches its proximal position, the ramp of the guide sleeve can contact the latch of the insert retractor. In this situation, the ramp is configured to twist the latch, thereby twisting the insert retractor. Specifically, the ramp of the guide sleeve can be configured to apply a force that twists the insert retractor by guiding the latch to move within the groove of the insertion sleeve.

[0053] The insertion movement can be completed when the cap is in its proximal position, where the cap can be aligned with the proximal end of the guide sleeve.

[0054] Movement of the cap, together with the insert retractor, from its proximal position to its distal position may be initiated by a user's easing of the action. Specifically, the user can reduce or stop applying force to the cap, thereby initiating movement of the cap, together with the insert retractor, from its proximal position to its distal position. The term "easing" as used herein is a broad term and should be given its ordinary and accustomed meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to, but is not limited to, the process of completely ceasing the application of an action and the process of partially ceasing the application of an action, such as by reducing or decreasing a force.

[0055] The elastic member can be configured to drive the insert retractor to move from its proximal position to its distal position. Specifically, the elastic member can be configured to retract the insert retractor after insertion of the medical device. The term “elastic member” as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to, but is not limited to, an element that, when compressed or extended from its rest position, can exert a force that counteracts the compression or extension. The elastic member can be configured to exert a force on one or more additional elements of the insertion device. Specifically, the elastic member can be compressed or extended when the medical device is inserted into body tissue, or the elastic member can be already in a compressed or extended state, such as a pretensioned state, prior to use of the insertion device. The elastic member can be or include at least one spring. The spring can be connected to the insert retractor. The spring can be pretensioned, particularly between the insertion sleeve and the insert retractor. In particular, a resilient member, preferably a spring, is disposed within the distal receptacle of the insertion sleeve. The spring prevents the insertion piece retractor and the cap from moving from their proximal positions to their distal positions as long as the user applies force to the cap. The spring may be actuated by releasing the force applied to the cap. Specifically, the spring may be configured to drive the insertion piece retractor and the cap from their proximal positions to their distal positions when the force applied to the insertion device is reduced and the latch of the insertion piece retractor moves beyond at least one edge of the at least one groove, i.e., to the proximal position of the insertion piece retractor. In the distal position, the latch may be released from the groove of the insertion sleeve, and the insertion piece retractor may be further twisted to be received by the internal structure of the cap. The insertion piece may be completely retracted from the body tissue.

[0056] As described above, the insertion device may include at least one plunger fixedly connected to the insertion piece. The plunger may also be referred to as a needle head. An insertion piece retractor may be connected to the plunger. The insertion piece retractor may be configured to engage with the plunger when moved from its proximal position to its distal position. Specifically, the insertion piece retractor may engage with the plunger using fingers, grippers, hooks, pliers, or the like. During retraction, the insertion piece retractor may move from its proximal position to its distal position, thereby engaging the plunger, which may move from the proximal position to the distal position together with the insertion piece fixedly engaged with the plunger. Thus, the insertion piece may be retracted by moving the insertion piece retractor from its proximal position to its distal position.

[0057] A short time delay of at least 100 ms may occur after insertion of the insertion part and before retraction of the insertion part begins. In particular, when the insertion device is applied to a user's skin site, the skin typically bulges toward the interior of the insertion device. The short time delay between when the insertion device, particularly the insertion part, is in the proximal position and when the insertion device, particularly the insertion part, is returned to the distal position allows pressure to be applied to the bulging skin. This facilitates sliding the insertion part, along with the medical device, into the skin and allows the user's skin to slide over the entire length of the insertion part and medical device.

[0058] The insertion device according to the present invention allows for greater skin tension compared to insertion devices known from the prior art, which has the effect that the insertion of the medical device into the user's body tissue may be more secure, and therefore the insertion device according to the present invention can ensure a safe and easy insertion of the medical device.

[0059] The insertion device may further include at least one safety lock. As used herein, the term "safety lock" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The term may specifically refer to, but is not limited to, a device or combination of devices configured to perform at least one safety function. The safety lock may be configured to prevent reuse of the insertion device, particularly after insertion of a medical device and retraction of an insertion component. The safety lock may be configured to prevent undesired reactivation of the insertion device. The safety lock may be configured to lock the insertion device, and a locked insertion device may be prevented from undesired reuse.

[0060] The safety lock can include one or more components attached to different components of the insertion device. For example, at least one safety notch can be disposed on the insertion sleeve and configured to receive the latch of the insert retractor. The safety notch can be disposed adjacent to a groove on the insertion sleeve such that the latch can be received within the safety notch when the groove guides the latch and insert retractor from their proximal position to their distal position. The latch can be received by the safety notch so that re-movement of the latch can be prevented. Specifically, the safety notch can prevent re-movement of the latch and insert retractor when the user applies a second force to the cap of the insertion device. Preventing re-movement of the insert retractor simultaneously prevents re-movement of the insert. Therefore, the risk of unintentional injury can be minimized.

[0061] The insertion device may be further configured to accept a sensor patch and attach the sensor patch to a user's skin site. The insertion device may be configured to attach and / or position the sensor patch at a user's skin site, particularly simultaneously with insertion of the insertion part into the user's body tissue. In particular, the sensor patch may be included in a receptacle of the insertion sleeve, particularly a receptacle located proximal to the insertion sleeve. Thus, the sensor patch may be configured to move with the insertion sleeve and be released from the insertion sleeve when the insertion sleeve is in its proximal position. The term "sensor patch" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not exclusively, refer to an element configured to be attached to a user's skin site. In particular, the sensor patch may have a flat base configured to be attached to a user's skin site. The sensor patch may include an electronics unit that may be configured to be connected to a medical device, particularly an analyte sensor. The electronics unit may have large dimensions compared to the analyte sensor and the insertion part. The diameter of the insert may be as large as 1 mm, and the sensor patch may extend up to 2 to 4 cm. The sensor patch may include at least one adhesive means for attachment to a user's skin site, such as a plaster. The sensor patch may remain attached to the user's skin site after the medical device is inserted into the user's body tissue. The insert may protrude through the sensor patch received by the insertion device. An insert retractor may be configured to grasp the insert within the sensor patch prior to insertion of the medical device.

[0062] In particular, when the insertion device includes a sensor patch, the insertion of the medical device becomes easier and more reliable. When the insertion device is applied to the skin, the skin typically bulges toward the inside of the insertion device. A short time delay between when the insertion device, particularly the insertion part, is in the proximal position and when the insertion device, particularly the insertion part, is returned to the distal position allows the sensor patch to apply pressure to the bulged skin. This compensates for the inward bulging of the skin as well as the inward bulging of the insertion part. Therefore, it becomes easier to slide the insertion part into the skin together with the medical device.

[0063] In a further aspect of the present invention, a method for inserting a medical device into a user's body tissue by using at least one insertion device according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below is disclosed. Therefore, for possible definitions and options, reference can be made to the disclosure of the insertion device according to the present invention. The method specifically includes the following steps, which can be performed in a given order. The method may include additional method steps not listed.

[0064] The method comprises: a) inserting the medical device into the user's body tissue by applying force to the cap of the insertion device, thereby moving the insertion piece, the cap, the insertion piece retractor, and the insertion sleeve from a distal position to a proximal position relative to the guide sleeve; b) retracting the insert by releasing the force applied to the cap, thereby moving the cap from its proximal position to its distal position, thereby moving the insert retractor from its proximal position to its distal position; Includes.

[0065] The movement of the cap together with the insertion piece retractor and insertion sleeve from its distal position to its proximal position can be initiated by a user action, in particular by applying a force to the cap of the insertion device. The force can be applied by a user of the insertion device before and during insertion of the medical device. The insertion of the medical device can be initiated by contacting the guide sleeve, in particular the proximal end of the guide sleeve, with the user's skin, in particular the insertion site. Thus, step a) of the method can include applying the insertion device to the user's skin site, in particular applying the guide sleeve of the insertion device to the user's skin site.

[0066] Prior to insertion, the insertion sleeve may be in its distal position and at least partially surrounded by the guide sleeve at its distal position. The cap may contact the insertion sleeve, particularly the distal end of the insertion sleeve. Prior to insertion, the insertion piece retractor may be in its starting position and at least partially surrounded by the insertion sleeve. The starting position of the insertion piece retractor is in a proximal position relative to the insertion sleeve. An elastic member may be between the insertion piece retractor and the insertion sleeve and may be at maximum tension. The insertion piece retractor may be locked in this position by at least one latch that can be received by an edge in a groove of the insertion sleeve.

[0067] When a user applies a force to the cap, the user's arm applying the force to the cap can accelerate in a proximal direction, particularly toward the user's skin. In embodiments, accelerating to a proximal position may require overcoming an initial force. After overcoming the initial force, the force required to move the insertion piece, cap, insertion piece retractor, and insertion sleeve relative to the guide sleeve may be lower than the initial force. Just before the insertion sleeve reaches its proximal position, the latch of the insertion piece retractor can contact at least one ramp of the guide sleeve, which ramp can particularly protrude inside the guide sleeve. The insertion piece retractor can be twisted by interaction between the ramp and the latch. The latch can loosen from an edge within the groove of the insertion sleeve and contact an internal structure of the cap. The user's arm can be stopped by contact between the insertion sleeve, particularly a sensor patch included in the insertion device in embodiments, and the user's skin. Due to the kinetic energy of the arm's mass, this stop can cause pressure of the insertion sleeve, particularly a sensor patch included in the insertion device in embodiments, against the user's skin.

[0068] Step b) may include reducing the force applied to the cap. Triggered by releasing the force applied to the cap, the insertion piece can be retracted from the user's skin site. When the user releases the force, an elastic element, particularly a spring, can move the insertion piece retractor, and thus the cap, to a distal position. The latch can slide along the groove of the insertion sleeve until the insertion piece is fully retracted from the user's body tissue. The latch may be biased by an internal structure of the cap, and the spring may apply force to further twist the insertion piece retractor to a position where the latch cannot move any further, specifically, where the insertion piece retractor cannot move any further proximally. Because the latch can be received by a safety lock, more specifically, a safety notch on the insertion sleeve, the insertion piece retractor cannot move any further proximally. Therefore, after insertion of the medical device, the insertion piece can be safely locked by the safety lock of the insertion device.

[0069] The insertion device according to the present invention can change the order of movements compared to known insertion devices. In known insertion devices, the insertion element can apply a force to the skin where the medical device is inserted. The skin bulges inward under this force. In known insertion devices, near the end of the insertion movement, the insertion element is retracted. However, due to the inward bulging and indentation of the skin under the impact of the insertion element, the medical device may not be fully inserted if the insertion element begins to rapidly disappear. Thus, the result may be a non-inserted or only partially inserted medical device. The insertion device according to the present invention compensates for this indentation of the skin by applying pressure to the skin, particularly by the sensor patch, while the insertion element still protrudes from the insertion device over its entire length into the skin. This can ensure reliable insertion of the medical device into the user's body tissue. The insertion element can then be retracted.

[0070] In an embodiment, a method for inserting a medical device into a user's body tissue by using an insertion device of the present invention comprising a sensor patch comprises the following steps: a1) contacting the proximal end of the insertion device, in particular the guide sleeve, with a skin site of a user; a) inserting the medical device into the user's body tissue by applying a force to the cap of the insertion device, thereby moving the insertion piece, cap, insertion piece retractor, and insertion sleeve from a distal position to a proximal position relative to the guide sleeve; b1) applying pressure to a skin site of a user with a sensor patch; b) Retracting the insert by releasing the force applied to the cap, thereby moving the cap from its proximal position to its distal position, thereby moving the insert retractor from its proximal position to its distal position.

[0071] The methods and devices of the present invention provide numerous advantages over known methods and devices, in particular, the insertion device of the present invention can allow a user to activate the retraction of the insertion part from the user's body tissue, thus increasing the reliability of the insertion of the medical device into the user's body tissue.

[0072] In summary, without excluding further possible embodiments, the following embodiments can be envisaged:

[0073] Embodiment 1 An insertion device for inserting a medical device into a body tissue of a user, comprising: i) a medical device; ii) an insertion piece configured to insert the medical device into body tissue; iii) an insert retractor; and iv) a cap; and v) a guide sleeve with at least one ramp; vi) an insertion sleeve; vii) Elastic members and Equipped with An insertion device in which the cap, the insert retractor, and the insertion sleeve are movable from a distal position to a proximal position relative to the guide sleeve to insert the medical device, a ramp on the guide sleeve is configured to twist the insert retractor relative to the guide sleeve and the insertion sleeve when the cap moves from its distal position to its proximal position, and the cap is movable from its proximal position to its distal position, thereby moving the insert retractor from its proximal position to its distal position.

[0074] Embodiment 2 The insertion device of embodiment 1, wherein movement of the cap together with the insertion piece retractor and insertion sleeve from its distal position to its proximal position is initiable by a user action.

[0075] Embodiment 3 An insertion device according to any one of embodiments 1 or 2, wherein movement of the cap together with the insertion piece retractor from its proximal position to its distal position can be initiated by easing the user's movement.

[0076] Embodiment 4 An insertion device described in any one of embodiments 1 to 3, wherein a ramp on the guide sleeve contacts a latch on the insertion component retractor before the insertion component retractor reaches a proximal position, and the ramp is configured to twist the latch, thereby twisting the insertion component retractor.

[0077] Embodiment 5 An insertion device as described in embodiment 4, wherein the insertion sleeve comprises at least one groove, the groove configured to guide the latch of the insertion part retractor, and the groove comprises at least one edge.

[0078] Embodiment 6 The insertion device of embodiment 5, wherein the ramp of the guide sleeve is configured to guide at least one latch to move within the groove of the insertion sleeve, thereby forcing the insertion piece retractor to twist.

[0079] Embodiment 7 An insertion device described in any one of embodiments 1 to 6, wherein the elastic member is configured to drive the insertion part retractor to move from its proximal position to its distal position, the elastic member having at least one spring, the spring connected to the insertion part retractor, the spring being pretensioned, and the spring being actuable by releasing the force applied to the cap.

[0080] Embodiment 8 An insertion device as described in embodiment 7, wherein at least one spring is configured to drive the movement of the insertion part retractor from its proximal position to its distal position, thereby driving the movement of the cap from its proximal position to its distal position.

[0081] Embodiment 9 An insertion device according to any one of embodiments 1 to 8, wherein the cap aligns with the proximal end of the guide sleeve when in the proximal position.

[0082] Embodiment 10 An insertion device described in any one of embodiments 1 to 9, wherein the insertion device further comprises at least one safety lock, the safety lock being configured to prevent re-movement of the insertion piece retractor after it has been moved to its distal position.

[0083] Embodiment 11 An insertion device according to any one of embodiments 1 to 10, wherein the medical device comprises at least one analyte sensor for detecting at least one analyte in a bodily fluid of a user.

[0084] Embodiment 12. The insertion device of embodiment 11, wherein the at least one analyte sensor comprises at least one two-electrode sensor.

[0085] Embodiment 13. An insertion device according to any one of embodiments 1 to 12, wherein the insertion device comprises a sensor patch.

[0086]

[0033] Embodiment 14. An insertion device as described in embodiment 13, wherein the sensor patch comprises a flat base configured to be attached to a skin site of a user.

[0087] Embodiment 15. An insertion device as described in embodiment 13 or 14, wherein the insertion device is configured to apply pressure to a skin site of a user with a sensor patch.

[0088] Embodiment 16: A method for inserting a medical device into a body tissue of a user by using at least one insertion device according to any one of embodiments 1 to 15, comprising: a) inserting the medical device into the user's body tissue by applying a force to the cap of the insertion device, thereby moving the insertion piece, the cap, the insertion piece retractor, and the insertion sleeve from a distal position to a proximal position relative to the guide sleeve; b) retracting the insert by releasing the force applied to the cap, thereby moving the cap from its proximal position to its distal position, thereby moving the insert retractor from its proximal position to its distal position; A method comprising:

[0089] Embodiment 17 A method for inserting a medical device into a body tissue of a user by using at least one insertion device according to any one of embodiments 1 to 12, wherein the insertion device comprises a sensor patch, and the method comprises the following steps: a1) contacting the proximal end of the insertion device, in particular the guide sleeve, with a skin site of a user; a) inserting the medical device into the user's body tissue by applying a force to the cap of the insertion device, thereby moving the insertion piece, cap, insertion piece retractor, and insertion sleeve from a distal position to a proximal position relative to the guide sleeve; b1) applying pressure to a user's skin site with a sensor patch; b) retracting the insert by releasing the force applied to the cap, thereby moving the cap from its proximal position to its distal position, thereby moving the insert retractor from its proximal position to its distal position; A method comprising:

[0090] Embodiment 18 The method of embodiment 16 or 17, wherein moving the cap together with the insertion part retractor and insertion sleeve from its distal position to its proximal position is initiated by a user action.

[0091] Embodiment 19. The method of any one of embodiments 16 to 18, wherein the movement of the cap, together with the insert retractor, from the proximal position of the cap to the distal position is initiated by easing the user's movement. [Brief explanation of the drawings]

[0092] Further optional features and embodiments are disclosed in more detail in the subsequent description of the embodiments, preferably in conjunction with the dependent claims. Here, each optional feature may be realized independently as well as in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated schematically in the figures. Here, the same reference numerals in these figures refer to the same or functionally equivalent elements. The diagram is as follows:

[0093] [Figure 1A] 1 shows a longitudinal cross-section of an embodiment of an insertion device according to the present invention. [Figure 1B] 1 shows a cross-sectional view of an embodiment of an insertion device according to the present invention. [Figure 1C] 1 shows a longitudinal cross-section of an embodiment of an insertion device according to the present invention. [Figure 2] 1 illustrates an exemplary embodiment of an insert retractor in a perspective view. [Figure 3] 1 illustrates an exemplary embodiment of a cap in a perspective view. [Figure 4] 1 illustrates an exemplary embodiment of a guide sleeve in a perspective view. [Figure 5] 1 illustrates an exemplary embodiment of an insertion sleeve in a perspective view. [Figure 6A]10 shows a longitudinal cross-sectional view of the anterior median plane of the insertion device during insertion of the medical device. [Figure 6B] 10 shows a longitudinal cross-sectional view of the anterior median plane of the insertion device during insertion of the medical device. [Figure 6C] 10 shows a longitudinal cross-sectional view of the anterior median plane of the insertion device during insertion of the medical device. [Figure 7A] 13 shows a longitudinal cross-sectional view of the anterior median plane of the insertion device after retraction of the insertion part. [Figure 7B] 13 shows a longitudinal cross-sectional view of the anterior median plane of the insertion device after retraction of the insertion part. [Figure 7C] 13 shows a longitudinal cross-sectional view of the anterior median plane of the insertion device after retraction of the insertion part. [Figure 8] 1 shows a flowchart of an embodiment of a method for inserting a medical device into a body tissue of a user. [Figure 9A] 1 shows a longitudinal cross-section in the median plane of the insertion device during insertion of the medical device. [Figure 9B] 1 shows a longitudinal cross-section in the median plane of the insertion device during insertion of the medical device. DETAILED DESCRIPTION OF THE INVENTION

[0094] 1A-1C show an exemplary embodiment of an insertion device 110 according to the present invention for inserting a medical device 112 into a user's body tissue. In FIG. 1A, the insertion device 110 is shown in a longitudinal cross-section, where the longitudinal cross-section is through the median plane of the insertion device 110. In FIG. 1B, a cross-sectional view is shown. In FIG. 1C, a longitudinal cross-section of the anterior median plane of the insertion device 110 is shown. FIGS. 1A-1C show the insertion device 110 prior to insertion of the medical device 112.

[0095] The medical device 112 may be any element or article configured for use in the field of medical technology, particularly in the field of medical analysis or medical diagnosis. The medical device 112 may be configured to perform at least one medical function and / or to be used in at least one medical process, such as one or more of a therapeutic process, a diagnostic process, or another medical process.

[0096] For example, the medical device 112 may be or include at least one analyte sensor 114 for detecting at least one analyte in a user's bodily fluid, such as a bodily fluid contained in the user's bodily tissue. The analyte sensor 114 may be configured for use in qualitatively and / or quantitatively detecting at least one analyte. The analyte may be a chemical and / or biological substance involved in the metabolism of the user's body. Specifically, the analyte may be a metabolite or a combination of two or more metabolites. By way of example, the analyte may be selected from the group consisting of glucose, lactate, triglycerides, and cholesterol. Additionally, other analytes or combinations of two or more analytes may be detected. The bodily tissue may be or include, specifically, adipose tissue and / or interstitium. However, other types of bodily tissue are also feasible.

[0097] The analyte sensor 114 may be a sensor capable of qualitatively or quantitatively detecting the presence and / or concentration of at least one analyte. For example, the analyte sensor 114 may be an electrochemical analyte sensor. The analyte sensor 114 may include at least two electrodes. Specifically, the analyte sensor 114 may include at least one two-electrode sensor. A two-electrode sensor can include exactly two electrodes, such as a working electrode, and at least one additional electrode, such as a counter electrode, particularly a combined working electrode and counter / reference electrode. The working electrode can include a working electrode pad and, optionally, at least one test chemical disposed thereon. The counter electrode can include a conductive electrode pad. Additionally, optionally, one or more redox materials can be disposed thereon. The analyte sensor 114 can further include one or more leads for electrically contacting the electrodes. The leads can be connected, during insertion or at a later point, to an electronics unit 116, such as one or more measuring devices adapted to measure current and / or voltage, such as one or more potentiostats. Preferably, the leads are already connected to the electronics unit 116 before insertion of the analyte sensor 114 .

[0098] Specifically, the analyte sensor 114 can be a strip-shaped analyte sensor having a flexible substrate and electrodes disposed thereon. By way of example, the analyte sensor 114 can have a total length of 5 mm to 50 mm, specifically, a total length of 7 mm to 30 mm.

[0099] The analyte sensor 114 may further comprise a biocompatible cover, such as a biocompatible membrane, that completely or partially covers the analyte sensor 114, prevents migration of test chemicals into body tissue, and allows diffusion of body fluids and / or analytes to the electrode.

[0100] Other embodiments of the electrochemical analyte sensor 114 may be possible, such as a three-electrode sensor. For example, a three-electrode sensor may include a reference electrode in addition to a working electrode and a counter electrode.

[0101] In another embodiment, the analyte sensor 114 may be an optical analyte sensor. For example, the analyte sensor 114 may include a flexible light guide with a glucose-sensitive coating on its end and / or a tubular carrier with functional elements on its inner or outer wall. Other embodiments of the analyte sensor 114 may also be possible. Reference may be made to the prior art documents mentioned above for potential embodiments of the analyte sensor 114.

[0102] In another embodiment not shown here, for example, medical device 112 can be or include at least one infusion cannula. The infusion cannula can be or include a hollow tube configured to deliver and / or inject a medication, particularly insulin, into a user's body tissue, particularly insulin, into a user's body tissue.

[0103] The user may be a person using the insertion device 110. The user may be a person intending to monitor analyte levels, such as glucose levels, in the person's body tissue and / or deliver medication, such as insulin, to the person's body tissue. For example, the user may be a patient suffering from a disease, such as diabetes.

[0104] Insertion of the medical device 112 may include one or more of percutaneously or subcutaneously implanting and / or positioning the medical device 112 within the user's body tissue. The medical device 112, such as the analyte sensor 114, may be fully or partially inserted into the body tissue. Insertion of the medical device 112 may be performed by using an insertion device 110. The insertion device 110 may be configured to insert the medical device 112 into the body tissue. The insertion device 110 may be configured to percutaneously or subcutaneously insert the medical device 112 into the body tissue, for example, by making an incision or puncture in the user's skin and moving the medical device 112 fully or partially into the body tissue. After insertion, the medical device 112, or at least a portion of the medical device 112, may remain within the user's body tissue for a predetermined period of time, such as several hours, specifically one day or more, more specifically up to one week, and even more specifically up to two weeks or more. The medical device 112 can be configured to continuously monitor and / or detect an analyte in a user's bodily fluid.

[0105] The insertion device 110 includes an insertion piece 118 , an insertion piece retractor 120 , a cap 122 , a guide sleeve 124 with at least one ramp 126 , an insertion sleeve 128 , and a resilient member 130 .

[0106] The insertion part 118 is configured to insert the medical device 112 into body tissue. The insertion part 118 may be at least partially insertable into body tissue, particularly for delivering or transporting additional elements. The insertion part 118 may be configured to support the insertion of the medical device 112. The insertion part 118 may include a tip or sharp end for inserting the medical device 112 into body tissue. The insertion part 118 may be or include an insertion cannula or an insertion needle.

[0107] As outlined above, after insertion, the medical device 112 can remain within the user's body tissue. However, the insert 118 can be retracted from the user's body tissue into the insert device 110 after inserting the medical device 112. To retract the insert 118, the insert device 110 can include an insert retractor 120. The insert retractor 120 can be configured to suspend the insert 118 during the insertion movement and to pull it out of the user's skin during the retraction movement. The engagement between the insert retractor 120 and the insert 118 can be loose. The engagement between the insert retractor 120 and the insert 118 can be established during the manufacturing process.

[0108] FIG. 2 illustrates an exemplary embodiment of an insert retractor 120 in a perspective view.

[0109] The insert retractor 120 can include at least one finger, gripper, hook, pliers, or the like configured to retract the insert 118. For example, the insert retractor 120 can include two or more fingers, grippers, hooks, or pliers arranged symmetrically around the insert 118. The fingers, grippers, hooks, pliers, or the like can be located at a proximal end of the insert retractor 120, and when the insertion device 110 is being used, the proximal end of the insert retractor 120 can face toward the user's body tissue. For example, in the exemplary embodiment shown in FIG. 2 , the insert retractor 120 can include three grippers 132. The grippers 132 can be located at a proximal end 134 of the insert retractor 120. The grippers 132 can be arranged symmetrically around the insert 118. For example, the insertion device 110 can include at least one plunger 119 connected to the insert 118. The insert retractor 120 may be connected to the plunger 119 and / or configured to grip the plunger 119 to drive the insert 118 to perform insertion and / or retraction movements. Specifically, the gripper 132 may be configured to retract the insert 118, particularly by being connected to and / or gripping the plunger 119, as outlined in more detail below.

[0110] The insert retractor 120 may further include at least one latch 136. The latch 136 may be at least one element that protrudes outward from the insert retractor 120, particularly perpendicular to the insertion direction 138. The insert retractor 120 may form a cylindrical body. The cylindrical body may be arranged concentrically with respect to the extension axis 160. The latch 116 may protrude outward from a side of the cylindrical body. Specifically, the latch 116 may protrude perpendicular to the insertion direction 138, which may be essentially parallel to the extension axis 160.

[0111] The latch 136 can be configured to guide the twisting of the insert retractor 120. The latch 136 can function as a guide wing that interacts with the insertion sleeve 128, the guide sleeve 124, and / or the cap 122. Torsional guiding can be distinguished from longitudinal guiding, which can be performed by using the cylindrical shape of the insert retractor 120 and its cylindrical counterpart within the insertion sleeve 128. Specifically, the latch 138 can be configured to slide within a groove 140 in the insertion sleeve 128 to guide the twisting of the insert retractor 120. The latch 138 can be configured to interact with other components of the insertion device 110, such as the ramp 126 of the guide sleeve 124. In the embodiment of FIG. 2, the insert retractor 120 can include at least two latches 136. The two latches 136 can be positioned opposite each other on the outside of the insert retractor 120. The interaction of the latch 136 with other components of the insertion device 110, specifically the interaction of the latch 136 with the groove 140 of the insertion sleeve 128 and / or the ramp 126 of the guide sleeve 124, is outlined in further detail below.

[0112] As shown in FIGS. 1A-1C , the cap 122 can be an element of any shape configured to fully or partially surround one or more components of the insertion device 110 and / or protect these components from mechanical influences, humidity, etc. FIG. 3 illustrates an exemplary embodiment of the cap 122 in a perspective view. The cap 122 can fully or partially surround and / or enclose one or more additional components, such as the insertion piece-retractor 120, the guide sleeve 124, and / or the insertion sleeve 128. For example, the cap 122 can completely surround the insertion sleeve 128 and the insertion piece-retractor 120. The cap 122 can also at least partially surround the guide sleeve 124, and thus completely cover the guide sleeve 124 except for the proximal end 142 of the guide sleeve 124. The cap 122 may be positioned to surround and / or enclose additional components of the insertion device 110, and a proximal side 144 of the insertion device 110 may be at least partially uncovered by the cap 122, allowing a user's skin to contact the guide sleeve 124 and move the insertion piece 118 outside the insertion device 110. When the cap 122 is in its proximal position 146, it may be aligned with the proximal end 142 of the guide sleeve 124. The proximal side 144 may be the side of the insertion device 110 that provides a contact area or region with the user's skin. The distal side 148 may be the side of the insertion device 110 opposite the proximal side 144.

[0113] The cap 122 can be or can include a rigid cap, such as a rigid cap made from one or more of a plastic material, a metal material, or a cardboard material.

[0114] The cap 122 can be rotationally symmetrical in nature, specifically by having axial rotational symmetry about an axis, such as the cylindrical axis or extension axis 160. The cap 122 can be designed as a cylinder, a hemisphere, or a dome. The cap 122 can have an internal structure 150 that does not have to be rotationally symmetrical. The outer shape of the cap 122 can also be asymmetrical, for example, ergonomically shaped to be held by a user's hand. The internal structure 150 of the cap 122 can be cylindrical or prismatic, corresponding to the structure of the insertion sleeve 128.

[0115] The cap 122 can further include at least one latch element 152, particularly on the internal structure 150 of the cap 122. The latch element 152 can be configured to hold the components of the insertion device 110 together. Specifically, the latch element 152 can interface the cap 122 with at least one of the guide sleeve 124, the insertion sleeve 128, and other components of the insertion piece retractor 120, particularly the insertion sleeve 128.

[0116] 1A-1C, the guide sleeve 124 can be an enclosure for one or more components configured to guide the movement of at least one of the enclosed components. The guide sleeve 124 can completely or partially surround the insert retractor 120 and / or the insert sleeve 128. The guide sleeve 124 can also be partially surrounded by the cap 122.

[0117] 4 illustrates, in perspective view, an exemplary embodiment of guide sleeve 124. Guide sleeve 124 may be rotationally symmetric in nature, specifically according to the symmetry of cap 122, and particularly the internal structure of cap 122. For example, if cap 122 can have axial rotational symmetry about an axis, such as cylindrical axis or extension axis 160, guide sleeve 124 can have similar axial rotational symmetry.

[0118] The guide sleeve 124 may be movable relative to the cap 122. For example, when the insertion device 110 is in use, the guide sleeve 124 may be configured to slide within the cap 122. The guide sleeve 124, and particularly the proximal end 142 of the guide sleeve 124, may contact the user's skin when the insertion device 110 is in use.

[0119] The ramp 126 of the guide sleeve 124 may include at least one inclined surface. The ramp 126 may be disposed inside the guide sleeve 124. Specifically, the ramp 126 may be disposed so as to face a component surrounded by the guide sleeve 124. The ramp 126 may protrude from the guide sleeve 124 into the interior of the guide sleeve 124. The ramp 126 may be or may include at least one wedge-shaped ramp. For example, the ramp 126 may include two inclined surfaces that contact each other, with the first inclined surface being inclined at an angle relative to the second inclined surface. The ramp 126 may be configured to interact with other components of the insertion device 110, specifically, at least one latch 136 of the insertion piece retractor 120. The ramp 126 may be received by a component surrounded by the guide sleeve 124, specifically, a groove 140 of the insertion sleeve 128. In FIG. 4 , the guide sleeve 124 may include two ramps 126. The number of ramps 126 may correspond to the number of latches 136. The ramps 126 may be disposed opposite each other inside the guide sleeve .

[0120] 1A-1C, the insertion sleeve 128 may be configured to at least partially surround the insertion piece retractor 120. The insertion sleeve 128 itself may be completely or partially surrounded by the guide sleeve 124 and cap 122 of the insertion device 110.

[0121] FIG. 5 illustrates an exemplary embodiment of the insertion sleeve 128 in a perspective view. The insertion sleeve 128 may be prismatic. The insertion sleeve 128 may be rotationally symmetric in nature, particularly according to the symmetry of the cap 122 and the guide sleeve 124. For example, the cap 122 and the guide sleeve 124 may have axial rotational symmetry about an axis, such as the cylindrical axis or extension axis 160, and the insertion sleeve 128 may have similar axial rotational symmetry. The insertion sleeve 128 may be configured to guide the insert-retractor 120. For example, to guide a cylindrically shaped insert-retractor 120, the insertion sleeve 128 may include a rotationally symmetric hollow center. The remainder of the insertion sleeve 128 may have an irregular cross-section.

[0122] The insertion sleeve 128 can include at least one receptacle 154. The receptacle 154 can be disposed at a distal end 156 of the insertion sleeve 128. The distal end 156 of the insertion sleeve 128 can refer to a portion of the insertion sleeve 128 that is distal to the user's skin. The receptacle 154 can have at least one opening 182. The insertion part 118 and / or the insertion part retractor 120 can extend at least partially through the opening 182. Specifically, the insertion part 118 can extend at least partially through the opening 182 such that at least a portion of the insertion part 118 can be disposed below the opening 182, and at least one other portion can be disposed above the opening 182. For example, the plunger 119 fixedly connected to the insertion piece 118 may extend through an opening 182 in the insertion sleeve 128, and other portions of the insertion piece 118, specifically the insertion cannula or needle, may be disposed below the opening 182 and may be surrounded by the insertion sleeve 128. As shown in FIG. 5 , the insertion sleeve 128 may include two receptacles 154, such as one receptacle 154 for the insertion piece retractor 120 that may open at a distal end 156 of the insertion sleeve 128, and one further receptacle 155 for the medical device 112 that may open at a proximal end 158 of the insertion sleeve 128. The proximal end 158 may be opposite the distal end 156 of the insertion sleeve 128.

[0123] The insertion sleeve 128 may include at least one groove 140. The groove 140 may be configured to guide the latch 136 of the insert retractor 120, particularly in a rotational manner for twisting the insert retractor 120. The groove 140 may be configured to guide the movement of the insert retractor 120 by restricting the direction of movement of the latch 136. The groove 140 may include or be one or more of a slot, a trench cut, and / or an opening in the insertion sleeve 128. The groove 140 may be a trench cut into the insertion sleeve 128 such that the groove 140 can only partially cut into the insertion sleeve 128. Alternatively and / or additionally, the groove 140 may be an opening in the insertion sleeve 128 such that the groove 140 can completely cut through the insertion sleeve 128. The groove 140 may extend essentially parallel to the extension axis 160 of the insertion sleeve 128. Specifically, the grooves 140 may extend parallel to the extension axis 160 or may vary at one or more locations from a direction parallel to the extension axis 160. For example, the grooves 140 may include at least one edge 162 and thus diverge from the extension axis 160 at the location of the edge 162. The edge 162 may be a z-shaped edge. Additionally and / or alternatively, the grooves 140 may be inclined at an angle relative to the extension axis 160.

[0124] The cross-sectional view of Figure 1B shows how the components of the insertion device 110 fit together or interlock with one another. Located at the center of the insertion device 110 is an insert retractor 120. The insert retractor 120 is guided by an insertion sleeve 128, which is surrounded by an internal structure 150 of the cap 122. Operating within the cap 122 and around the internal structure 150 is a guide sleeve 124. The guide sleeve 124 has two inward-facing ramps 126.

[0125] The longitudinal cross-sectional view of Figure 1C visualizes how the latch 136 of the insertion piece retractor 120 operates and functions in conjunction with the internal structure 150 of the insertion sleeve 128 and cap 122. As outlined above, Figures 1A-1C show the insertion device 110 prior to insertion of the medical device 112. In this position, the latch 136 may be captured by the z-shaped edge 162 of the insertion sleeve 128. The elastic member 130 pushes from below, but the latch 136 cannot move upward.

[0126] 6A-6C show various longitudinal cross-sectional views of the anterior medial plane of the insertion device 110 during insertion of the medical device 112. Specifically, FIGS. 6A-6C show the insertion and retraction movements of the insertion device 110.

[0127] To insert the medical device 112, the cap 122, the insert retractor 120, and the insertion sleeve 128 are movable relative to the guide sleeve 124 from a distal position 164 to a proximal position 166. Because the guide sleeve 124 is positioned on the user's skin, the guide sleeve 124 can be considered a fixed or non-moving component of the insertion device 110. Other components, such as the medical device 112, the insert 118, the insert retractor 120, the insertion sleeve 128, and the cap 122, can move proximally relative to the guide sleeve 124 and relative to the user's skin.

[0128] The distal position 164 may refer to a position spaced apart relative to a user's skin site. The distal position 164 may be an initial position of the insertion device 110 and / or any portion thereof prior to an insertion movement. Each component of the insertion device 110 may have its own and / or individual distal position 164. For example, the cap 122, the insert retractor 120, and the insertion sleeve 128 may each have their own and / or individual distal position 164. Prior to insertion, as shown in FIG. 1 , the cap 122, the insert retractor 120, and the insertion sleeve 128 may be in their distal positions 164, ready to insert the medical device 112 into the user's body tissue. After insertion, the cap 122 and the insert retractor 120 may return to their respective distal positions 164, and the insertion device 118 may be retracted from the body tissue, at which time the insert retractor 120 may return to its distal position 164.

[0129] The proximal position 166 may be a position of the insertion device 110 and / or any portion thereof relative to a user where the insertion piece 118 and / or cap 122 are closest to the proximal side 144 of the insertion device 110. Specifically, the insertion device 110 can be contacted with a user's skin site to insert the medical device 112. The proximal position 166 may refer to a position that is close to the user's skin site. Each component of the insertion device 110 can have its own and / or individual proximal position 166. For example, the cap 122, the insertion piece retractor 120, and the insertion sleeve 128 can each have its own and / or individual proximal position 166. When the cap 122, the insertion piece retractor 120, and the insertion sleeve 128 are in their proximal positions 166, the medical device 112 can be inserted into the user's body tissue. During insertion of the medical device 112, the guide sleeve 124 may contact the user's skin site and therefore may be in its proximal position 166 during insertion.

[0130] The movement of the cap 122, along with the insertion piece retractor 120 and insertion sleeve 128, from its distal position 164 to its proximal position 166 may be initiated by a user action. Specifically, the user action can be or include the user applying a force to the cap 122, such as by manually pressing and / or pushing the cap 122 downward to the proximal position, particularly to the user's skin.

[0131] 6A shows the start of insertion into the user's skin. The guide sleeve 124 is placed on the user's skin at its proximal end 142. The user pushes on the cap 122, which preferably overcomes the initial force so that the components of the insertion device 110 move together. The ramp 126 approaches the latch 126. At the same time, the insertion piece 118 emerges from the guide sleeve 124 and begins to penetrate the skin.

[0132] 6B, the cap 122, insert retractor 120, and insertion sleeve 128 are shown closed prior to reaching their proximal position 166. The ramp 126 can contact the latch 136. In this situation, the ramp 126 of the guide sleeve 124 is configured to twist the insert retractor 120 relative to the guide sleeve 124 and insertion sleeve 128.

[0133] The twisting can be or include rotational movement of the insert-retractor 120 about the axis of rotation 168. The twisting can be rotational movement of the insert-retractor 120 itself, for example, about the axis of rotation 168, which coincides with the axis of extension of the cylindrical body of the insert-retractor 120. Specifically, the insert-retractor 120 can be rotationally symmetric in nature, and the twisting can be rotational movement about the axis of symmetry of the insert-retractor 120. The twisting can be an angle of less than 90°, specifically less than 45°, and more specifically less than 15°. Other embodiments are possible in which the twisting can be greater than about 90°, or even greater than 180°.

[0134] During insertion, movement of the insert retractor 120 from its proximal position 166 to its distal position 164 can be prevented by the internal structure 150 of the cap 122 and the force applied to the cap 122 by the user. The internal structure 150 can be or include a stop and / or blocking element 170 configured to receive the latch 136 of the insert retractor 120 and specifically block movement of the latch 136 to prevent movement of the insert retractor 120 from its proximal position 166 to its distal position 164 during insertion. In the situation of FIG. 6B , the ramp 126 of the guide sleeve 124 can be configured to guide the latch 136 to move within the groove 140 of the insertion sleeve 128, thereby forcing a twisting of the insert retractor 120.

[0135] FIG. 6C shows the cap 122, insert retractor 120, and insertion sleeve 128 in their proximal position 166. The insertion movement can be completed when the cap 122 is in the proximal position 166. When the cap 122 is in the proximal position 166, it can be aligned with the proximal end 142 of the guide sleeve 124. In this situation, the ramp 126 can be configured to move the latch 136 past the edge 162 of the groove 140. The elastic member 130 can further twist the latch 136 and the insert retractor 120 so that the latch 136 can be received by the internal structure 150 of the cap 122. In this situation, the user can still apply force to the cap 122 such that the elastic member 130 cannot drive the movement of the insert retractor 120 from the proximal position 166 to the distal position 164. The insertion piece 118 is capable of completely penetrating the user's skin, thereby allowing the medical device 112 to be inserted into the user's body tissue.

[0136] The movement of the cap 122, together with the insert retractor 120, from its proximal position 166 to its distal position 164 may be initiated by a user's reduction in motion. Specifically, the user may reduce or stop applying force to the cap 122, thereby initiating movement from its proximal position 166 to its distal position 164. The elastic member 130 may be configured to drive the insert retractor 120 to move from its proximal position 166 to its distal position 164. Specifically, the elastic member 130 may be configured to retract the insert retractor 120 after insertion of the medical device 112. The elastic member 130 may be or include at least one spring 171. The spring 171 may be connected to the insert retractor 120. The spring 171 may be pretensioned, particularly between the insertion sleeve 128 and the insert retractor 120. As long as the user applies force to the cap 122, the spring 171 cannot move the insert retractor 120 and the cap 122, respectively, from their proximal position 166 to their distal position 164. The spring 171 may be actuable by releasing the force applied to the cap 122.

[0137] As described above, the insertion device 110 may include at least one plunger 119 fixedly connected to the insert 118. The insert retractor 120 may be connected to the plunger 119. The insert retractor 120 may be configured to engage with the plunger 119 when moved from its proximal position 166 to its distal position 164. Specifically, the insert retractor 120 may engage with the plunger 119 using the gripper 132. During retraction, the insert retractor 120 may move from its proximal position 166 to its distal position 164, thereby engaging the plunger 119, which may move from the proximal position 166 to the distal position 164 with the insert 120 fixedly engaged with the plunger 119. Thus, the insert 118 may be retracted by moving the insert retractor 120 from its proximal position 166 to its distal position 164.

[0138] A short time delay of at least 100 ms may occur after insertion of the insertion part 118 and before retraction of the insertion part 118 begins. In particular, when the insertion device 110 is applied to a user's skin site, the skin typically bulges toward the interior of the insertion device 110. The short time delay between when the insertion device, particularly the insertion part, is in a proximal position and when the insertion device, particularly the insertion part, is returned to a distal position allows pressure to be applied to the bulging skin. This facilitates sliding the insertion part 118, along with the medical device 112, into the skin, allowing the user's skin to slide over the entire length of the insertion part 118 and medical device 112.

[0139] 7A to 7C show longitudinal cross-sectional views of the anterior medial plane of the insertion device 110 after retraction of the insertion piece 118, i.e., after it has returned to the distal position 164. FIG.

[0140] 7A, in the distal position 164, the latch 136 may be released from the groove 140, and the insert retractor 120 may be twisted to be received in the internal structure 150 of the cap 122. The insert 118 may be fully retracted from the body tissue. FIG. 7B illustrates the function of the latch element 152 in interlocking the cap 122 with other components of the insertion device 110.

[0141] The insertion device 110 may further include at least one safety lock 172, as shown in FIG. 7C. The safety lock 172 may be configured to prevent re-movement, and in particular reuse, of the insertion device 110, particularly after insertion of the medical device 112 and retraction of the insertion piece 118. The safety lock 172 may be configured to prevent undesired re-actuation of the insertion device 110. The safety lock 172 may be configured to lock the insertion device 110, and a locked insertion device 110 may be prevented from undesired reuse.

[0142] The safety lock 172 can comprise one or more components attached to different components of the insertion device 110. For example, at least one safety notch 174 can be disposed on the insertion sleeve 128 and configured to receive the latch 136 of the insert retractor 120. The safety notch 174 can be disposed adjacent to the groove 140 of the insertion sleeve 128 such that the latch 136 can be received within the safety notch 174 when the groove 140 guides the latch 136 and the insert retractor 120 from their proximal position 166 to their distal position 164. The latch 136 can be received by the safety notch 174 so that re-movement of the latch 136 can be prevented. Specifically, the safety notch 174 can prevent re-movement of the latch 136 and the insert retractor 120 when the user applies force to the cap 122 again. Thus, the risk of unintentional injury can be minimized.

[0143] For example, as seen in FIG. 1A , the insertion device 110 may be further configured to receive a sensor patch 176 and attach the sensor patch 176 to a user's skin site. The insertion device 110 may be configured to attach and / or position the sensor patch 176 to a user's skin site, particularly upon insertion of the insert 118 into the user's body tissue. The sensor patch 176 may include an electronics unit 116 that may be configured to connect to the medical device 112, particularly the analyte sensor 114. The sensor patch 176 may include at least one adhesive means, such as a plaster, for attachment to the user's skin site. The sensor patch 176 may remain attached to the user's skin site after the medical device 112 is inserted into the user's body tissue. The insert 118 may protrude through the sensor patch 176 received by the insertion device 110. The insert retractor 120 may be configured to grip the insert 118 within the sensor patch 176 prior to insertion of the medical device 112.

[0144] 8 shows a flowchart of an exemplary embodiment of a method for inserting a medical device 112 into a user's body tissue. The method includes using an insertion device 110 according to the present invention, for example, according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below. Accordingly, reference may be made to the descriptions of FIGS. 1 through 7C. The method specifically includes the following steps, which may be performed in a given order. The method may include additional steps not listed.

[0145] The method comprises: a) inserting the medical device 112 into the user's body tissue by applying a force to the cap 122 of the insertion tool 110 (indicated by reference numeral 178), thereby moving the insertion piece 118, the cap 122, the insertion piece retractor 120, and the insertion sleeve 128 from a distal position 164 to a proximal position 166 relative to the guide sleeve 124; b) retracting the insert 118 by releasing the force applied to the cap 122 (indicated by reference numeral 180), thereby moving the cap 122 from its proximal position 166 to its distal position 164, thereby moving the insert retractor 120 from its proximal position 166 to its distal position 164; Includes.

[0146] Moving the cap 122 together with the insertion piece retractor 120 and insertion sleeve 128 from its distal position 164 to its proximal position 166 can be initiated by a user action, specifically by applying a force to the cap 122 of the insertion device 110. The force can be applied by a user of the insertion device 110 before and during insertion of the medical device 112. Insertion of the medical device 112 can be initiated by contacting the guide sleeve 124, specifically the proximal end 142 of the guide sleeve 124, with the user's skin, specifically the insertion site. Thus, step a) of the method can include applying the insertion device 110 to the user's skin site, specifically applying the guide sleeve 124 of the insertion device 110 to the user's skin site.

[0147] Prior to insertion, the insertion sleeve 128 may be in its distal position 164 and at least partially surrounded by the guide sleeve 124 at its distal position 164. The cap 122 may be in contact with the insertion sleeve 128, specifically the distal end 156 of the insertion sleeve 128. Prior to insertion, the insertion piece retractor 120 may be in its starting position and at least partially surrounded by the insertion sleeve 128. The elastic member 130 may be between the insertion piece retractor 120 and the insertion sleeve 128 and may be at maximum tension. The insertion piece retractor 120 may be locked in this position by at least one latch 136 that can be received by a lip 162 in a groove 140 of the insertion sleeve 128.

[0148] When a user applies force to the cap 122, the user's arm applying the force to the cap 122 can accelerate in a proximal direction, particularly toward the user's skin. Just before the insertion sleeve 128 reaches its proximal position 166, the latch 136 of the insertion piece retractor 120 can contact at least one ramp 126 of the guide sleeve 124, which ramp 126 can protrude inward of the guide sleeve 124. The insertion piece retractor 120 can be twisted by the interaction of the ramp 126 and the latch 136. The latch 136 can loosen from an edge 162 within the groove 140 of the insertion sleeve 128 and contact an internal structure 150 of the cap 122. The user's arm can be stopped by contact between the insertion sleeve 128, particularly a sensor patch 176 included in one embodiment of the insertion device, and the user's skin. Due to the kinetic energy of the arm's mass, this stop can cause the insertion sleeve 128, and in particular the sensor patch 176 included in the insertion device in embodiments, to press against the user's skin.

[0149] Step b) may include reducing the force applied to the cap 122. Triggered by releasing the force applied to the cap 122, the insert 118 can be removed from the user's skin site. When the user releases the force, the spring 171 can move the insert retractor 120, and thus the cap 122, to the distal position 164. The latch 136 can slide along the groove 140 of the insertion sleeve 128 until the insert 118 is fully retracted from the user's body tissue. The latch 136 may be biased by the internal structure 150 of the cap 122, and the spring 171 may apply force to further twist the insert retractor 120 to a position where the latch 136 cannot move any further, specifically, where the insert retractor 120 cannot move any further proximally. Because the latch 136 can be received by the safety lock 172, more specifically, the safety notch 174 of the insertion sleeve 128, the insert retractor 120 cannot move any further proximally. Thus, after insertion of the medical device 112 , the insertion piece 118 can be safely locked by the safety lock 172 of the insertion device 110 .

[0150] The insertion device 110 of the present invention can change the order of movement compared to known insertion devices. In known insertion devices, the insertion element can apply a force to the skin where the medical device is inserted. The skin bulges inward under this force. In known insertion devices, near the end of the insertion movement, the insertion element is retracted. However, due to the inward bulging and indentation of the skin under the impact of the insertion element 118, the medical device may not be fully inserted if the insertion element begins to rapidly disappear. Thus, the result may be a non-inserted or only partially inserted medical device. The insertion device 110 of the present invention compensates for the indentation of the skin by applying pressure to the skin, particularly with the sensor patch 176, while the insertion element 118 still protrudes from the insertion device 110 into the skin over its entire length. This can ensure reliable insertion of the medical device 112 into the user's body tissue. The insertion element 118 can then be retracted.

[0151] 9A and 9B visualize the effect of applying pressure to the raised skin by the sensor patch 176, specifically allowing for compensation for the inward bulging of the skin. 9A and 9B show longitudinal cross-sectional views in the medial plane of the insertion device 110 during insertion of the medical device 112. For a description of the insertion device 110 shown in FIGS. 9A and 9B, reference is made to the descriptions of FIGS. 1 to 7C. In the exemplary embodiment shown in FIGS. 9A and 9B, the insertion device 110 includes a sensor patch 176.

[0152] FIG. 9A shows the insertion device 110 during insertion of the medical device 112 as the insertion piece 118 begins to penetrate the user's skin. When the insertion device 110, specifically the proximal end 142 of the guide sleeve 124, is applied to the user's skin, the skin typically bulges toward the interior of the insertion device 110. The skin bulge is indicated by reference numeral 184 in FIG. 9A. Penetration of the insertion piece 118 through the user's skin can cause a skin indentation, as indicated by reference numeral 186 in FIG. 9A. During insertion of the medical device 112, the sensor patch 176 can be pressed against the user's skin (see FIG. 9B) before the cap 122, insertion piece retractor 120, and insertion sleeve 128 reach their proximal positions 166. The short time delay between when the insertion device, particularly the insert, is in the proximal position and when the insertion device, particularly the insert, is returned to the distal position allows pressure to be applied by the sensor patch 176 to the bulging skin, as indicated by arrow 188. This pressure allows compensation for the inward bulging of the skin as well as the inward bulging caused by the insert 118. This therefore facilitates sliding the insert 118, along with the medical device 112, into the skin, as described above. [Explanation of symbols]

[0153] 110 Insertion device 112 Medical Devices 114 Analyte Sensors 116 Electronics Unit 118 Insertion Parts 119 Plunger 120 Insertion Part Retractor 122 Cap 124 Guide sleeve 126 Lamp 128 Insertion Sleeve 130 Elastic member 132 Gripper 134 Proximal end of insert retractor 136 Latch 138 Insertion Direction 140 Groove 142 Proximal end of guide sleeve 144 Proximal side of insertion device 146 Proximal position of cap 148 Distal side of insertion device 150 Internal structure 152 Latching Elements 154 Receptacle 155 Medical device receptacle 156 Distal end of insertion sleeve 158 Proximal end of insertion sleeve 160 Extension shaft 162 Edge 164 Distal position 166 Proximal position 168 Rotational Axis 170 Blocking Elements 171 Spring 172 Safety Lock 174 Safety Notch 176 Sensor Patch 178 Insertion of Medical Devices 180 Insertion part retraction 182 Opening 184 Skin bumps 186 Skin depressions 188 Pressure

Claims

1. An insertion device (110) for inserting a medical device (112) into a body tissue of a user, comprising: i) the medical device (112); ii) an insertion piece (118) configured to insert the medical device (112) into the body tissue; iii) an insert retractor (120); iv) a cap (122); v) a guide sleeve (124) with at least one ramp (126); vi) an insertion sleeve (128); vii) an elastic member (130); viii) a sensor patch (176); Equipped with To insert the medical device (112), the cap (122), the insert retractor (120), and the insertion sleeve (128) are movable relative to the guide sleeve (124) from a distal position (164) to a proximal position (166), and the ramp (126) of the guide sleeve (124) is configured to twist the insert retractor (120) relative to the guide sleeve (124) and the insertion sleeve (128) when the cap (122) moves from its distal position (164) to its proximal position (166), thereby moving the insert retractor (120) from its proximal position (166) to its distal position (164); The insertion device (110) is configured to press the sensor patch (176) against the user's skin during insertion of the medical device (112) before the cap (122), the insertion piece retractor (120), and the insertion sleeve (128) reach the proximal position (166).

2. 2. The insertion device (110) of claim 1, wherein movement of the cap (122), together with the insertion piece retractor (120) and the insertion sleeve (128), from its distal position (164) to its proximal position (166) can be initiated by an action of the user.

3. 3. The insertion device (110) of claim 1 or 2, wherein movement of the cap (122) together with the insertion piece retractor (120) from its proximal position (166) to its distal position (164) can be initiated by easing the user's movement.

4. 4. The insertion device (110) of claim 1, wherein the ramp (126) of the guide sleeve (124) contacts a latch (136) of the insert retractor (120) before the insert retractor (120) reaches the proximal position (166), and the ramp (126) is configured to twist the latch (136) and thereby twist the insert retractor (120).

5. 5. The insertion device (110) of claim 4, wherein the insertion sleeve (128) comprises at least one groove (140), the groove (140) configured to guide the latch (136) of the insertion piece retractor (120), and the groove (140) comprises at least one edge (162).

6. 6. The insertion device of claim 5, wherein the ramp of the guide sleeve is configured to guide the at least one latch to move within the groove of the insertion sleeve, thereby forcing a twist of the insertion piece retractor.

7. 7. The insertion device (110) according to any one of claims 1 to 6, wherein the elastic member (130) is configured to drive the insertion piece retractor (120) to move from its proximal position (166) to its distal position (164), the elastic member (130) comprising at least one spring (171), the spring (171) connected to the insertion piece retractor (120), the spring (171) being pretensioned and actuatable by releasing a force applied to the cap (122).

8. 8. The insertion device (110) of claim 7, wherein the at least one spring (171) is configured to drive the movement of the insertion piece retractor (120) from its proximal position (166) to its distal position (164), thereby driving the movement of the cap (122) from its proximal position (166) to its distal position (164).

9. The insertion device (110) of any one of claims 1 to 8, wherein the cap (122) aligns with the proximal end (142) of the guide sleeve (124) when in the proximal position (166).

10. 10. The insertion device (110) of any one of claims 1 to 9, further comprising at least one safety lock (172), the safety lock (172) configured to prevent re-movement of the insertion piece retractor (120) after it has been moved to its distal position (164).

11. 11. The insertion device (110) of claim 1, wherein the medical device (112) comprises at least one analyte sensor (114) for detecting at least one analyte in a bodily fluid of a user.

12. The insertion device (110) of claim 11, wherein the at least one analyte sensor (114) comprises at least one two-electrode sensor.

Images