Insertion device

Abstract

The invention proposes an insertion device (112) for inserting at least an insertable portion of a medical device (110) into a body tissue (114) of a subject, the insertion device comprising:-at least one housing (116) having at least one retaining structure (118) adapted to releasably receive the medical device (110); -at least one insertion tool (120) configured for inserting at least the insertable portion of the medical device; -at least one wheel (132) comprising a guide structure (134) configured for guiding an axial movement of the insertion tool (120) and the retaining structure (118) between a distal position and a proximal position; and-at least one torsional drive (146) configured for rotating the wheel (132) upon activation, in which the guide structure (134) comprises a shape having an eccentricity with respect to the center of the wheel (132) and / or with respect to the point of rotation of the wheel (132), in which the eccentricity is not equal to zero, and in which the guide structure (134) has a shape having an eccentricity with respect to the center of the wheel (132) and / or with respect to the point of rotation of the wheel (132). And wherein the shape is configured to slow linear movement about a point of rotation of the insertion tool (120).

Description

Technical Field

[0001] This invention relates to an insertion device, insertion system, and method for inserting at least an insertable portion of a medical device into the body tissue of a subject. The medical device can be specifically configured to detect at least one analyte in the subject's bodily fluids. The insertion device, insertion system, and method can be applied to the field of continuous monitoring of analytes in a subject's bodily fluids, particularly in home care and professional care fields, such as hospitals. However, other applications are also possible. Background Technology

[0002] Monitoring specific bodily functions, and more particularly monitoring the concentrations of one or more analytes, such as the concentrations of one or more metabolites in a subject's bodily fluids, plays a vital role in the prevention and treatment of a variety of diseases. Such analytes may include, for example, but not limited to, glucose, lactate, cholesterol, or other types of analytes and metabolites. Without limiting other possible applications, the invention will be described below with reference to glucose monitoring. However, additionally or alternatively, the invention may also be applied to other types of analytes.

[0003] In addition to optical measurements, blood glucose monitoring can be specifically performed using electrochemical biosensors. Beyond so-called single-point measurements, which involve selectively extracting bodily fluid samples from a user and checking analyte concentrations, continuous measurements are increasingly being established. Therefore, recently, for example, continuous measurement of glucose in interstitial tissue (also known as continuous monitoring, CM) has been established as another important method for managing, monitoring, and controlling diabetes.

[0004] In this process, the active sensor region is applied directly to the measurement site, which is typically located in the interstitial tissue, and glucose is converted into a charge, for example, by using an enzyme (e.g., glucose oxidase, GOD), which is related to the glucose concentration and can be used as a measurement variable. Examples of such transdermal measurement systems are described in US 6,360,888 B1 or US 2008 / 0242962 A1.

[0005] Therefore, current continuous monitoring systems are typically percutaneous or subcutaneous systems. This means that the actual sensor, or at least the measuring portion of the sensor, is placed under the user's skin. However, the evaluation and control portion of the system (also known as a patch) is usually located outside the user's body, outside the human or animal body. In this process, the sensor is typically applied using an insertion device, also described in illustrative form in US 6,360,888 B1. Other types of insertion devices are also known. Typically, subcutaneous analyte sensors are based on a plastic substrate and therefore cannot be inserted on their own, requiring a metal cannula. The insertion cannula typically has a special cavity for placing the sensor therein. During the insertion process, the cannula containing the sensor penetrates the skin and retracts, allowing the sensor to be inserted. One important function of the insertion device is to move the cannula at a defined initial velocity to successfully penetrate the skin without causing excessive pain. To achieve initial momentum, the insertion mechanism typically has a mechanical assembly that releases the cannula after a certain predefined force threshold is exceeded during the insertion process.

[0006] Insertors for invasive medical devices, configured to insert sensors or cannulas for drug delivery, are known in the prior art. They typically use one or two tension or compression springs to achieve insertion and retraction movement of the cannula.

[0007] US 2015 / 0025338 A1 describes an apparatus for applying a skin-on sensor assembly to the skin of a host, the apparatus comprising: a base configured to hold a housing, wherein the housing is configured to receive an electronic unit, wherein the electronic unit is configured to generate analyte information based on signals from a sensor; a sensor insertion mechanism configured to insert a sensor into a host; and a trigger configured to, in response to being activated, cause the sensor insertion mechanism to insert the sensor into the host to hold the electronic unit to the housing, such that the sensor makes electrical contact with the electronic unit, and to detach the housing from the base.

[0008] US 2013 / 0267811 A1 describes systems and methods for measuring analytes in a host. More specifically, the described embodiments provide a sensor applicator and a method for use with button activation, wherein the sensor is implanted, the insertion pin is withdrawn, the transmitter is engaged with the housing, and the applicator is disengaged from the housing, all in a smooth motion. Some embodiments contemplate engaging the transmitter with the housing after the applicator is released.

[0009] US 11,400,215 B2 describes a drug delivery device for delivering a drug from a container to an infusion site via a cannula. The device includes a chassis, a drive mechanism for driving a piston member along a container axis to expel the drug through the cannula, and a holder for holding the container, the cannula, and the drive mechanism. An insertion mechanism is provided for moving the holder in an insertion direction relative to the chassis, and a cannula bending mechanism is provided for bending the cannula about a bending axis to substantially align at least an end portion of the cannula with the insertion direction before the holder moves in the insertion direction.

[0010] US 2009 / 0198215 A1 describes various embodiments of patches for medical devices. In various embodiments, the adhesive patch of the medical device may have selective regions of adhesive material with varying adhesive strengths. In other embodiments, the adhesive patch of the medical device may include an adhesive material that can be activated by a catalyst to increase or decrease the adhesive strength of the adhesive material. In a further embodiment, the medical device may include a puncture-resistant membrane containing a drug substance, the membrane being positioned to be punctured by a needle and to deliver some of the drug substance to a user-patient.

[0011] EP 1 090 584 B1 describes a lancet unit for collecting blood samples for diagnostic purposes, comprising a drive spring and a rotor having a working surface at the apex of which is at a maximum distance from its axis of rotation and is connected to a lancet holder in such a way that the lancet tip emerges from the lancet opening when the rotor is within an angular thrust zone following each apex relative to the spring roller.

[0012] US 7,273,484 B2 describes a blood aspiration system for drawing blood for diagnostic purposes. The blood aspiration system includes a housing with a lancet movable within it. The housing also includes a lancet actuator with a drive spring and a trigger mechanism including an actuating element. The blood aspiration system of the present invention further includes a lancet ejection mechanism that can move from an active position for removing the lancet to a passive position where removal of the lancet is not possible.

[0013] The devices known to date still present several technical challenges. Specifically, known inserters typically require technically complex designs to achieve safe and well-adjusted insertion and extraction of the insertor cannula (with sensors or flexible cannulas). Therefore, there is a need for improved inserters.

[0014] Problems to be solved Therefore, it is desirable to provide an insertion device, insertion system, and method for inserting at least the insertable portion of a medical device into the body tissue of a subject, which at least partially addresses the aforementioned technical challenges. Specifically, it is desirable to provide an insertion device, insertion system, and method for inserting at least the insertable portion of a medical device into the body tissue of a subject, which a) allows for a reliable insertion process of at least the insertable portion of the medical device, b) is less technically complex in design compared to devices known to date, and / or c) is cheaper to manufacture. Summary of the Invention

[0015] At least some of the problems are addressed by insertion means, insertion systems, and methods having the features of the independent claims for inserting at least the insertable portion of a medical device into the body tissue of a subject. Advantageous embodiments that can be implemented individually or in any combination are set forth in the dependent claims and throughout the specification.

[0016] As used below, the terms “have,” “contain,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer either to a situation where no other features exist in the entity described in this context besides those introduced by these terms, or to a situation where one or more other features exist. For example, the statements “A has B,” “A includes B,” and “A contains B” can refer to a situation where no other elements exist in A besides B (i.e., where A is solely and uniquely composed of B); or to a situation where one or more other elements (such as element C, element D, or even other elements) exist in entity A besides B.

[0017] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist once or more are generally used only once when introducing the corresponding feature or element. In the following text, in most cases, when referring to the corresponding feature or element, the expressions "at least one" or "one or more" will not be used repeatedly, even though the corresponding feature or element may exist only once or more.

[0018] Furthermore, as used hereinafter, the terms “preferredly,” “more preferably,” “particularly,” “more particularly,” “specifically,” “more specifically,” or similar terms are used in combination with optional features without limiting the possibility of substitution. Therefore, features introduced by these terms are optional and are not intended to limit the scope of the claims in any way. As those skilled in the art will recognize, the invention can be practiced by using alternative features. Similarly, features introduced by “in one embodiment of the invention” or similar expressions are intended to be optional features without limiting alternative embodiments of the invention, without limiting the scope of the invention, and without limiting the possibility of combining features introduced in this way with other optional or non-optional features of the invention.

[0019] In a first aspect of the invention, an insertion device is disclosed for inserting at least an insertable portion of a medical device into the body tissue of a subject. The insertion device includes: - At least one housing having at least one retaining structure suitable for releasably receiving a medical device. - At least one insertion tool configured for inserting at least the insertable portion of a medical device. - At least one wheel, comprising a guide structure configured to guide the insertion tool and retaining structure for axial movement between a distal position and a proximal position, and - At least one torsion drive, which is configured to rotate the wheel after startup.

[0020] The guide structure includes a shape with an eccentricity relative to the center of the wheel and / or relative to the rotation point of the wheel. The eccentricity is not zero. This shape is configured to slow down linear movement around the rotation point of the insertion tool.

[0021] This invention can be associated with designs or architectures that are far simpler than those known to date for insertion systems, because it eliminates the need for separate actuators or mechanisms to achieve controlled insertion and retraction movement of the insertion tool. Therefore, manufacturing costs, processes, and expenses can be reduced.

[0022] As used herein, the term "subject" is a broad term and will be given a meaning common and customary to those skilled in the art, and is not limited to a particular or customary meaning. The term specifically refers to a human or animal, whether or not the human or animal is actually in a healthy state or may suffer from one or more diseases. A subject may be a patient. As an example, a subject may be a human or animal suffering from diabetes. A subject may be a user who wants to monitor analyte values ​​(such as glucose levels) in a user's body tissues and / or deliver medication (such as insulin) to a user's body tissues, such as a patient. However, in embodiments, the user who inserts the device may be different from the subject. Additionally or alternatively, the invention may be applied to other types of users or patients.

[0023] As used herein, the term "medical device" is a broad term and will be given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term may refer to (but is not limited to) any element or object configured for use in the field of medical technology, exemplarily for use in the field of medical analysis or medical diagnosis. A medical device may be configured to perform at least one medical function and / or be used in at least one medical procedure, such as a treatment procedure, a diagnostic procedure, or one or more other medical procedures.

[0024] The medical device can be configured to be mounted on a skin site of a subject, such as the limbs. The limbs can be selected from the group consisting of: arms, exemplarily the upper arm; abdomen; shoulders; back; hips; and legs. For example, the limbs can be the upper arms. However, other applications may also be possible.

[0025] The medical device may include at least one component that can be configured to remain outside of body tissue. Further, the medical device may include at least one insertable portion. The insertable portion may be configured for insertion into the body tissue of a subject. Exemplarily, an insertion device may be configured to insert the insertable portion of the medical device into the body tissue of a subject.

[0026] Medical devices may include at least one device selected from the group consisting of: analyte sensor devices, such as analyte sensor devices configured to detect at least one analyte in a subject's bodily fluids; infusion devices, such as drug infusion devices configured to infuse a liquid medication (such as insulin or any other liquid medication) into a subject's tissues; and electrical stimulation devices, such as those configured to stimulate a subject's body tissues. Such infusion devices include an infusion pump, also known as a patch pump or infusion cannula, which is attached to the patient's skin and connected via tubing to the infusion cannula to deliver medication from the pump to the skin. Known patch pumps include insulin pumps, such as Roche's Accu-Chek® Solo Micropump or Terumo's Medisafe patch pump. Known infusion cannulas include, in sequence, Roche's Accu-Chek® Insight Flex or Tandem's Diabetes AutoSoft infusion cannula or infusion cannulas manufactured by Convatec® (such as Neria Guard).

[0027] For example, the medical device may include at least one analyte sensor device. The analyte sensor device may include at least one analyte sensor configured to detect at least one analyte in a subject's bodily fluids. The insertion tool of the insertion device may be configured to insert at least a portion of the analyte sensor into the subject's body tissue, such as at least one insertable portion.

[0028] As used herein, the term "analyte sensor device" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a device configured for detecting at least one analyte in the bodily fluids of a subject.

[0029] As used herein, the term "analyte" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, chemical and / or biological substances involved in the metabolism of a subject's body. Exemplarily, an analyte may be a metabolite or a combination of two or more metabolites. As an example, an analyte may be selected from the group consisting of: glucose, lactate, triglycerides, and cholesterol. Glucose is a preferred analyte. Other analytes or combinations of two or more analytes may still be detected. Body tissue may, exemplary or may include, adipose tissue and / or interstitial tissue. However, other types of body tissue are also feasible.

[0030] An analyte sensor can be configured for the qualitative and / or quantitative detection of at least one analyte. As used herein, the term "analyte sensor" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may 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.

[0031] The analyte sensor may be an electrochemical analyte sensor. The analyte sensor may include at least two electrodes. Specifically, the analyte sensor may include at least one dual-electrode sensor. A dual-electrode sensor may precisely include two electrodes, such as a working electrode and at least one other electrode, such as a relative electrode, for example, a working electrode and a combined relative / reference electrode. The working electrode may include a working electrode pad and optionally at least one test chemical disposed thereon. The relative electrode may include a relative electrode pad. Additionally and optionally, one or more redox materials may be disposed thereon. The analyte sensor may further include one or more leads for electrically contacting the electrodes. The leads may be connected to one or more electronic components during insertion or at a later point in time. For example, the leads may have been connected to electronic components before insertion of the analyte sensor. For example, the analyte sensor may be a needle-shaped or strip-shaped analyte sensor having a flexible substrate and electrodes disposed thereon. As an example, the analyte sensor may have an overall length of 5 mm to 50 mm, specifically 7 mm to 30 mm. The term "total length" in the context of this invention refers to the total length of the analyte sensor, meaning both the portion of the analyte sensor inserted and the portion that may remain outside body tissue. The portion of the analyte sensor inserted is also referred to as the in vivo portion, and the portion that may remain outside body tissue is also referred to as the in vitro portion. For example, the in vivo portion has a length ranging from 3 mm to 12 mm. The analyte sensor may further include a biocompatible covering, such as a biocompatible membrane, which completely or partially covers the analyte sensor and prevents the test chemical from migrating into body tissue while allowing bodily fluids and / or analytes to diffuse to the electrodes. Other embodiments of electrochemical analyte sensors, such as three-electrode sensors, may be feasible. For example, in addition to a working electrode and a counter electrode, a three-electrode sensor may also include a reference electrode. Such analyte sensors are generally known in the art and include continuous glucose sensor systems, such as Dexcom's G6 or G7 glucose sensor systems, Medtronic's Enlite glucose sensor, or Abbott's Freestyle Libre 2 or 3.

[0032] The analyte sensor can be an optical analyte sensor. For example, the analyte sensor may include a flexible light guide with a glucose-sensitive coating at its ends and / or a tubular carrier with functional elements on its inner or outer walls. Other embodiments of the analyte sensor are also possible.

[0033] As used herein, the term "body fluid" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to any fluid that is normally present in the body or body tissues of a user or patient and / or can be generated by the body of a user or patient. As an example of body tissue, interstitial tissue may be named. Thus, as an example, body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids, such as saliva, tears, urine, or other body fluids, may be used. Body fluid may be present in the body or body tissues during the detection of at least one analyte.

[0034] A medical device may include at least one electronic unit. An analyte sensor may be operatively connected to the electronic unit. As used herein, the term "electronic unit" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, any unit, such as a unit that can be held in a monolithic form, configured to perform at least one electronic function. For example, in the case of a medical device for detecting an analyte in a user's bodily fluids, the electronic unit may have at least one interface for connecting to the analyte sensor, wherein the electronic unit can provide at least one electronic function that interacts with the analyte sensor, such as at least one measurement function. The electronic unit may be configured to perform one or more of the following: determining and / or controlling the detection of the analyte and / or transmitting measurement data to another component. Specifically, the electronic unit may be configured to perform one or more of the following: performing measurements using the analyte sensor, performing voltage measurements, performing current measurements, recording sensor signals, storing measurement signals and / or measurement data, and transmitting sensor signals to another component. Therefore, the electronic unit may specifically include at least one of the following: a voltmeter, an ammeter, a potentiometer, a voltage source, a current source, a signal receiver, a signal transmitter, an analog-to-digital converter, an electronic filter, a data storage device, or an energy storage device. For example, the electronic unit may be implemented as a transmitter or may include at least one transmitter configured to transmit data to a remote computer or remote device.

[0035] The medical device may further include at least one electronic remote device configured to communicate with and / or control the medical device. The electronic remote device may be selected from a variety of sources, including: a personal computer, a wearable computer, a smartphone, a proprietary remote control, a tablet computer, or a server.

[0036] For example, a medical device may include at least one infusion device. As used herein, the term "infusion device" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term relates to a device configured for delivering and / or infusing at least one drug into a user's body tissue, such as for delivering and / or infusing insulin into a user's body tissue. The infusion device may be a drug infusion device. The infusion device may include at least one infusion cannula. An insertion tool of the insertion device may be configured to insert at least a portion of the infusion cannula into the subject's body tissue. As used herein, the term "infusion cannula" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may, exemplarily, refer to, but is not limited to, a hollow tube configured for delivering and / or infusing a drug into a subject's body tissue, such as for delivering and / or infusing insulin into a subject's body tissue.

[0037] For example, a medical device may include at least one electrical stimulation device. As used herein, the term "electrical stimulation device" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term relates to a device configured to apply at least one electrical stimulation to body tissue. The electrical stimulation device may include stimulation electrodes. An insertion tool may be configured to insert at least a portion of the stimulation electrodes into the body tissue of a subject.

[0038] As used herein, the term "insertion" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term may refer to, but is not limited to, the act or process of percutaneously or subcutaneously implanting and / or placing one or more medical devices, exemplarily insertable portions of medical devices, into and / or placing into the body tissues of a subject. The medical device may be partially inserted into the body tissue. Insertion of the medical device can be performed using an insertion device. After insertion, at least the insertable portion of the medical device may remain in the body tissues of the subject for a predetermined period of time, such as several hours, exemplarily one day or more days, such as up to one week, or such as up to two weeks or longer.

[0039] As used herein, the term "insertion device" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term relates to a device configured to insert at least an insertable portion of a medical device into body tissue. An insertion device can be configured to insert at least an insertable portion of a medical device percutaneously or subcutaneously into body tissue, such as by making an incision or puncture in the skin of a subject and by partially transferring the medical device into the body tissue. After the medical device has been at least partially inserted into the body tissue of the subject, the insertion device can be completely or partially removed.

[0040] As described above, the insertion device includes at least one housing having at least one retention structure adapted to releasably receive a medical device.

[0041] As used herein, the term "shell" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to an element or assembly having at least one internal space and at least one wall, which completely or partially surrounds and provides protection to the at least one internal space, such as mechanical protection and protection against environmental influences such as moisture, oxygen, and microbial contamination. A shell is generally adapted to completely or partially enclose and / or receive one or more elements to provide one or more of the following: mechanical protection, mechanical stability, environmental protection against moisture and / or ambient atmosphere, shielding against electromagnetic influences, etc. A shell may also provide a basis for attaching and / or securing one or more additional parts or elements.

[0042] As used herein, the term "retaining structure" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term refers to any element configured to at least partially enclose at least one element, such as a medical device and / or an insertion tool, and / or to at least partially retain at least one element in a desired position. A retaining structure may be configured to retain a medical device, i.e., a medical device retainer, and / or a retaining structure may be configured to retain an insertion tool, i.e., an insertion tool retainer. For example, a retaining structure may be configured to retain an insertion tool and may be used as a medical device retainer. Alternatively, the insertion tool retainer and the medical device retainer may be two separate elements.

[0043] As will be outlined in more detail below, the retaining structure may be or may include at least one plunger, or may be connected to at least one plunger to drive the insertion tool to perform puncture or insertion movements into body tissue to insert the medical device and return it.

[0044] Exemplarily, the retaining structure may include at least one receiving portion, and the medical device may be at least partially received in the receiving portion. For example, the retaining structure may include a rotationally symmetric hollow center. The rotationally symmetric hollow center may, exemplarily, open towards a proximal end of the retaining structure. The medical device may be disposed at the proximal end of the retaining structure. The retaining structure may include one or more elements configured to engage with the medical device, exemplarily engaging with a surface of the medical device, for supporting and retaining the medical device in place. The retaining structure may include one or more of at least one finger, at least one gripper, at least one hook, at least one forceps, etc. The elements may be disposed within the internal structure of the retaining structure, exemplarily within the internal structure of the receiving portion of the retaining structure. Other embodiments are also possible. Exemplarily, the retaining structure may include at least one adhesive element. The element may be disposed within the internal structure of the retaining structure, exemplarily within the internal structure of the receiving portion of the retaining structure.

[0045] As used herein, the term "releasably receive medical device" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, this term relates to the fact that the connection between the retaining structure and the medical device is at least one of separable, detachable, and non-permanent. The retaining structure can be configured to directly or indirectly withdraw the insertion tool from the medical device while leaving at least the inserted portion of the medical device in body tissue. As used herein, the term "direct withdrawal" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, this term relates to embodiments in which the retaining structure is configured to apply at least one force to the medical device to release and / or disconnect the retaining structure and the medical device. As used herein, the term "indirect withdrawal" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, this term relates to embodiments in which at least one force is applied to the retaining structure and / or additional components of the insertion device to release and / or disconnect the retaining structure and the medical device.

[0046] The retaining structure can be configured to directly or indirectly advance the retaining structure and at least the insertable portion of the medical device axially toward body tissue and to insert the insertion tool and at least the insertable portion of the medical device into the body tissue. As used herein, the term "advancement" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. This term specifically relates to acceleration, such as from rest to a specified speed. As used herein, the term "direct advancement" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. This term specifically relates to embodiments in which the retaining structure is configured to apply at least one force to the medical device to advance the medical device. As used herein, the term "indirect advancement" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. This term specifically relates to embodiments in which at least one force is applied to the retaining structure and / or additional components of the insertion device to advance the medical device.

[0047] As used herein, the term "axial movement" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to movement in an axial direction. The axial direction may be defined by the extension axis of the insertion device, such as the extension axis of the housing. More specifically, the term means movement toward or away from the skin, and specifically, movement substantially perpendicular to the surface of the skin to which the insertion device may be attached.

[0048] The insertion device may include at least one insertion locking mechanism. The insertion locking mechanism may be configured to lock and release movement of the retaining structure. The insertion locking mechanism may be configured to interact with one or more of the wheels, retaining structure guides, or medical devices. For example, advancing the retaining structure may be triggered by releasing the insertion locking mechanism. As used herein, the term "insertion locking mechanism" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term refers to a means or combination of means suitable for performing at least one locking function. For example, by interacting with one or more of the wheels, retaining structure guides, or medical devices, the insertion locking mechanism may be at least one mechanism configured to lock and / or release movement of the retaining structure, such as a plunger of the retaining structure.

[0049] For example, an insertion locking mechanism can be adapted to prevent unintended actuation of the insertion device, thereby preventing unintended actuation of the retaining structure. As an example, the retaining structure is movably supported within the housing, such as by providing one or more bearings or one or more guides, such as one or more rails or tracks. For example, the retaining structure can be stored or guided within the housing of the insertion device in a linearly movable manner. The retaining structure can have a retracted position or a rest position, in which the retaining structure is stored prior to insertion, and in which the insertion tool does not protrude from the insertion device. The insertion locking mechanism can be adapted to prevent the retaining structure from unintendedly leaving the rest position or stored position and / or can be adapted to generally prevent unintended activation of the insertion device. As used herein, the term "activation" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term specifically relates to the actuation of the insertion device and / or the movement of the device toward a distal position of the retaining structure. The insertion locking mechanism may include at least one locked position and at least one unlocked position, wherein in the locked position, unwanted activation can be blocked, and wherein in the unlocked position, the insertion device is activated, thereby enabling insertion of the insertable portion of the medical device into body tissue. For example, the insertion locking mechanism in the locked position is adapted to at least partially block rotation of the wheel and / or maintain movement of the structure. The insertion locking mechanism may further function as a transport lock or transport safety device, such as for preventing unwanted activation of the insertion device during transport or storage. Additionally, additional transport locking devices or transport safety devices may be implemented.

[0050] The insertion locking mechanism may include one or more blocking elements. The blocking elements may abut one or more elements of the insertion device, such as a wheel and / or retaining structure in the locked position. The one or more blocking elements may be movable and may directly or indirectly abut against the wheel or a portion thereof in the locked position to prevent rotation of the wheel and / or movement of the retaining structure. In the unlocked position, the one or more blocking elements may retract the wheel and / or retaining structure to release the wheel and / or retaining structure and to allow rotation of the wheel and / or movement of the retaining structure. For example, the blocking element may be at least one locking arm configured to prevent the retaining structure from moving from a distal position to a proximal position.

[0051] As used herein, the term "distal position" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to a positional specification indicating the position of an insertion device and / or any part thereof and / or a medical device relative to a subject, wherein the insertion tool, retaining structure, and / or medical device is furthest from the proximal side of the insertion device. Exemplarily, in order to insert at least an insertable portion of the medical device, the insertion device may be brought into contact with a skin site of the subject. A distal position may refer to a position away from the skin site of the subject. A distal position may be the initial position prior to insertion movement of the insertion device and / or any part thereof. Each component of the insertion device may have its own and / or separate distal position. For example, the insertion tool, retaining structure, and / or medical device may each have their own and / or separate distal positions. Prior to insertion, the insertion tool, retaining structure, and / or medical device may be in their distal positions and ready for insertion of at least an insertable portion of the medical device into the subject's body tissue.

[0052] As used herein, the term "proximal position" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to a positional specification indicating the location of an insertion device and / or any part thereof and / or a medical device relative to a subject, wherein the insertion tool, retaining structure, and / or medical device is closest to the proximal side of the insertion device. Exemplarily, for insertion of a medical device, the insertion device may be made to contact a part of the subject's skin. A proximal position can refer to a location very close to the subject's skin. Each component of the insertion device may have its own and / or individual proximal position. For example, the insertion tool, retaining structure, and / or medical device may each have their own and / or individual proximal positions. With the insertion tool, retaining structure, and / or medical device in their proximal positions, the medical device can be inserted into the subject's body tissue. During insertion of the medical device, the medical device may contact the subject's skin and thus may be in its proximal position.

[0053] The insertion locking mechanism can be operated manually. To operate the insertion locking mechanism, such as by triggering its release, the mechanism may include at least one operating element, such as at least one switch, for example, at least one slide switch, push button, pull release device, at least one removable pin, etc. However, other types of operating elements are also feasible.

[0054] For example, the retaining structure may include at least one plunger. The plunger may also be referred to as a piston, piston rod, or push rod. The plunger may be configured to attach directly or indirectly, for example, via at least one additional element, to a medical device and / or an insertion tool. The plunger may be configured to directly or indirectly advance the medical device axially toward the skin and insert an insertion tool (e.g., an insertion cannula) into the skin in a first stage. The plunger may be configured to withdraw the insertion tool from the medical device while leaving the inserted portion of the medical device in the skin in a second stage.

[0055] The retaining structure may include at least one retaining structure guide, such as a guide for a plunger. As used herein, the term "retaining structure guide" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term refers to at least one element configured to guide movement of the retaining structure. Guiding may include directing the movement of the retaining structure. For example, the housing may include at least one guide frame configured to guide axial movement of the retaining structure guide between its distal and proximal positions. An insertion locking mechanism may include at least one locking arm configured to engage with the retaining structure guide to prevent movement of the retaining structure from its distal to its proximal position. At least one retaining structure guide may be specifically present at the interface between the retaining structure guide and the guide frame, wherein at least one retaining structure guide is configured to guide axial movement of the retaining structure in contact with a corresponding guide structure of the guide frame. Examples of guiding elements include rails, channel armatures, grooves, tenons, and slots.

[0056] As described above, the insertion device includes at least one insertion tool configured for inserting at least an insertable portion of a medical device. As used herein, the term "insertion tool" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically refers to any element that can be at least partially inserted into body tissue, particularly for the delivery or transfer of additional elements. The insertion tool can be configured to support the insertion of the insertable portion of the medical device. Exemplarily, the insertion tool can be configured to support the insertion of the insertable portion of the medical device. The insertion tool may include a tip or point for inserting the insertable portion of the medical device, exemplary, into body tissue. In the context of this invention, the insertion tool is considered part of the insertion device. However, particularly during the manufacture of the insertion system, the insertion tool may also be considered an insertable portion of the medical device. Therefore, during insertion, the insertion tool can perform a puncture motion from a distal to a proximal position, thereby creating an incision in the user's or patient's skin, transferring at least the insertable portion of the medical device into the body tissue, and subsequently, a reverse motion is performed, wherein the insertion tool is pulled out of the body tissue, and wherein at least the insertable portion of the medical device remains at least partially within the body tissue. During insertion, at least the insertable portion of the medical device can be completely or partially surrounded by the insertion tool. As described above, the retention structure can be or may include at least one plunger adapted to axially push the insertion tool to perform the puncture motion, and may be further adapted to axially retract the insertion tool after insertion. After insertion, the insertable portion of the medical device may remain in the subject's body tissue. However, after insertion of the medical device, the insertion tool can be retracted from the subject's body tissue back into the insertion device.

[0057] Insertion tools may include at least one insertion cannula or at least one insertion needle. As used herein, the term "insertion cannula" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a hollow needle that may be at least partially slotted, such as being U-shaped, triangular, elliptical, or circular. At least an insertable portion of a medical device may be received within the insertion cannula, such as within the lumen of the insertion cannula. As used herein, the term "insertion needle" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a compact needle, exemplary without slots and without any hollow portion. Medical devices (such as the flexible cannula of an infusion sleeve for a patch pump) may be accommodated on the outer surface of the insertion needle.

[0058] The insertion device may include an insertion tool protection mechanism, such as an insertion cannula or insertion needle protection mechanism, configured to prevent the retaining structure from moving again toward the proximal position. Using an insertion cannula or insertion needle protection mechanism can protect the subject from contact with the exposed insertion tool. For example, an insertion locking mechanism can be used as an insertion cannula or insertion needle protection mechanism. Using the same mechanism allows for design simplification. Alternatively, a different mechanism than the insertion locking mechanism can be used to prevent movement of the retaining structure. For example, the insertion device may be configured to lock the retaining structure after retraction. Many safety measures for securing the retracted insertion tool within the housing may be feasible. For example, a torsion spring, described in more detail below, may be locked and / or disengaged from the wheel, for example, once the retaining structure reaches its distal position. For example, the retaining structure (e.g., a plunger and / or the insertion tool) may be locked, for example, once the retaining structure reaches its distal position.

[0059] As described above, the insertion device includes at least one wheel, which includes a guide structure configured to guide the insertion tool and retain the structure for axial movement between a distal position and a proximal position.

[0060] As used herein, the term "wheel" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term refers to at least one element configured to exert rotational movement about an axis or center. For example, the shape of a wheel can be selected from the group consisting of: circular, elliptical, non-circular, triangular, rectangular, or polygonal. A wheel can be a flywheel. A wheel can be a cam or a face cam.

[0061] As used herein, the term "guide structure" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, at least one or more two-dimensional or three-dimensional structures configured to guide movement, for example, defining the speed and / or acceleration of axial movement of an insertion tool and a retaining structure. The guide structure may be a guide rail and / or a guide channel. As used herein, the term "guide channel" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a groove within the surface plane of a wheel. As used herein, the term "guide rail" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may also specifically refer to, but is not limited to, a protrusion extending from the surface plane of a wheel.

[0062] The guide structure includes a shape that is eccentric relative to the center of the wheel and / or relative to the point of rotation of the wheel. The eccentricity is not equal to zero.

[0063] For example, the shape of the guide structure, for instance, in a plan view, is selected from the group consisting of: non-circular, elliptical, spiral, and triangular. For example, the shape of the guide structure can be circular. Alternatively, the shape can be configured such that, although the angular movement speed of the wheel is substantially constant, the time the structure remains in the extended position (such as the proximal position) is longer than in the case of a strictly circular shape with zero eccentricity. This non-circular shape can allow for an increase in the time the structure remains in the extended position. Compared to inserters known to date that operate at high speeds during insertion and retraction essentially throughout the entire insertion process, this design is associated with the advantage that the insertion according to the invention provides more time for the insertable portion of the medical device to penetrate deeper into the skin before the insertion tool is pulled back: during the insertion of the insertable portion of the medical device into the skin, due to the inertia of the skin, the skin region adjacent to the insertion point, especially when insertion occurs at a high axial movement speed, will move away from the medical device. As the speed of axial movement of the insertion tool around its point closest to the skin slows down, the concave portion of the skin around the insertion point has more time to relax and move upward toward the medical device. This improves the insertion of the insertable portion of the medical device because the insertable portion penetrates the skin more deeply before the axial retraction movement accelerates again to pull the insertable tool out of the skin, while leaving the insertable portion in place.

[0064] In other embodiments, a circular shape is also possible, for example, when using non-circular wheels and / or non-central mounting points.

[0065] As used herein, the term "center of the wheel" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the mounting point of the wheel. The center may be the center of gravity. However, other mounting points are also possible. As used herein, the term "point of rotation of the wheel" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the point around which the wheel rotates. The wheel may have several points of rotation, for example, at different times during movement. The shape is configured to slow linear movement around the point of rotation of the insertion tool. As used herein, the term "point of rotation of the insertion tool" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the point around which the movement of the insertion tool from a distal position to a proximal position is reversed.

[0066] The insertion device (e.g., a wheel) may include at least one follower. The follower may be attached to a retaining structure. A guide structure may be configured to guide the follower. As used herein, the term "follower" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term may specifically refer to, but is not limited to, elements of any shape configured to engage with and move along a guide structure. For example, a follower may be a follower pin. The follower pin may move within a guide channel. The guide structure may guide the follower pin. The follower may be attached to a retaining structure. For example, the follower may be a skid or trailer that moves on a guide rail. The skid or trailer may be attached to the retaining structure. The shape of the guide structure may cause friction with the follower to increase at or partially at the last corner position.

[0067] As described above, the insertion device includes at least one torsion drive configured to rotate the wheel upon startup. As used herein, the term "torsion drive" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically relates to a drive mechanism that operates by torsion. For example, the torsion drive includes at least one torsion spring. For example, when the torsion spring is loaded, the torsion spring is torsioned, and upon startup, a torque can be applied in the opposite direction, thereby applying a rotational force to the wheel. The wheel is configured to rotate in response to the rotational force applied by the torsion drive. The torsion drive (e.g., the torsion spring) may be preloaded, for example, at the factory. The torsion drive (e.g., the torsion spring) may be user-loadable; for example, the torsion drive may be reloadable. As used herein, the term "rotates the wheel upon startup" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term specifically relates to the fact that a torsion force applies a rotational force to the wheel, thereby triggering and / or driving the rotation of the wheel.

[0068] The insertion device may include at least one protective cap. As used herein, the term "protective cap" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a portion of the housing configured to protect the medical device and / or other components of the insertion device prior to use, such as during storage, supply, or sale. One or more of the housing or protective cap may include at least one desiccant. Such protective caps and desiccants in the sense of this invention are further described in EP3727130A1 and EP3202323A1. The protective cap may be configured to cover a skin-facing opening of the housing. The protective cap may be configured to provide an original closure of the insertion device. For example, removal of the protective cap may release and / or disengage an insertion-blocking locking mechanism.

[0069] The protective cover can be removed from the insertion device by at least one twisting movement. As an example, the protective cover can be attached to the housing via at least one of a form-fit connection or a press-fit connection. The protective cover can be attached to the housing via one or more of a friction contact, threads, etc. The edge of the protective cover can be pushed onto the edge of the housing, or vice versa. Thus, as an example, the protective cover can have a circular, elliptical, or polygonal edge that fits snugly onto the edge of the housing with a corresponding shape, or vice versa. In the connected state, there may be an overlapping area where the protective cover overlaps with the housing, or vice versa.

[0070] The protective cover may be made wholly or partially of at least one rigid material, such as at least one plastic material and / or at least one metal. The protective cover may have an opening configured to point toward the housing of the insertion device. The protective cover may be made substantially rotationally symmetrical, for example, by having axial rotational symmetry about an axis, such as a cylindrical axis. As an example, the protective cover may be designed as a cylinder, hemisphere, or dome.

[0071] For example, the torsion actuator can be pre-tensioned at the factory or by the user, preferably by pulling down a protective cover, which in turn tensions the torsion actuator. For example, the protective cover is connected to the rotating axis via a filament that, when removed from the housing, rotates the axis in the direction of tensioning the torsion spring. A ratchet mechanism at the rotating axis can be used to ensure that the rotating axis remains tensioned after the filament is pulled out from the rotating axis.

[0072] Insertion devices may include friction brakes. As used herein, the term "friction brake" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, operation via friction braking. Friction brakes may function in a proximal position to the insertion tool and retaining structure. Additionally or alternatively, the frictional resistance of the friction brake is increased relative to other angular positions or portions of the guide structure. Friction brakes may be configured to interact with the wheel and / or retaining structure. For example, the guide structure may be shaped in a manner capable of altering the frictional resistance between the guide structure and the follower pin. This resistance can then be used to control the speed of movement of the wheel, and thus the speed of movement of the retaining structure during insertion and retraction. Alternatively or in combination with alterations to the shape of the guide structure, the frictional resistance may be controlled by one or more of the materials, surface textures, or coatings used in different portions of the guide structure.

[0073] The insertion device includes at least one braking element. In a position near the retaining structure, such as the maximum extension position of the plunger, at least a portion of the wheel may contact the braking element. As used herein, the term "braking element" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, at least one element configured to reduce rotational speed (e.g., the angular velocity of the wheel). The braking element may be configured to slow the angular velocity of the wheel within a defined angular braking interval. Once the end of the braking interval is reached, the braking element may stop inhibiting wheel movement, and the wheel may accelerate to retract the insertion tool. For example, the insertion device may be configured such that the plunger stops moving or moves at a very low speed to at least one limited angular interval of wheel movement before retraction begins. For example, the wheel diameter may be large during the braking angular interval. In this respect of the wheel, the outer edge may contact the braking element, resulting in slowing the wheel's movement. The braking element may include a rod, such as a surface with high resistance, like rubber. As an addition or alternative to extending the wheel's diameter at angular intervals, the wheel's thickness can be locally increased such that the brake element contacts the wheel only in the region of increased thickness. Additionally or alternatively, the wheel may include a follower pin extending radially outward from the wheel and contacting a brake element, such as a leaf spring. Alternatively, the follower pin may be mounted on the side of the wheel and oriented perpendicular to the wheel's circular plane. Control of the axial movement speed of the insertion tool and retaining structure via the brake element can also be combined with control provided by a friction brake.

[0074] The insertion device may include a medical device locking mechanism. As used herein, the term "medical device locking mechanism" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, at least one and / or more elements configured to prevent the medical device from being pulled back into the housing when the retaining structure withdraws the insertion tool from the medical device. For example, the medical device locking mechanism may include a flexible locking arm configured to prevent the medical device from being pulled back into the housing when the retaining structure withdraws the insertion tool from the medical device.

[0075] The insertion device may include at least one user interface. As used herein, the term "user interface" is a broad term and should be given its common and customary meaning to those skilled in the art, and should not be limited to a particular or customary meaning. The term may refer to, but is not limited to, elements or devices configured to interact with their environment, such as for the purpose of exchanging information in one or both directions, such as for exchanging one or more data or commands. For example, a user interface may be configured to share information with and receive information from a user. The user interface may be a feature that interacts with the user's vision, such as a display, or a feature that interacts with the user's hearing. As an example, the user interface may include a sound generator configured to play at least one sound when insertion has been successfully completed. Specifically, the sound generator may also be configured to play a melody, such as Kool & the Gang's "Celebration".

[0076] In another aspect of the invention, the insertion system includes at least one medical device and at least one insertion means according to the invention (e.g., as described in the first aspect above or as described in more detail below) for inserting the medical device at least partially into the body tissue of a subject. The medical device is held in place by a retaining structure. For possible definitions and options, refer to the disclosure of the insertion means according to the invention.

[0077] As used herein, the term "system" is a broad term and will be given a meaning common and customary to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a group of at least two elements that can interact with each other to achieve at least one common function. The at least two elements may be processed independently or coupled, connected, or integrated to form a common device.

[0078] As used herein, the term "insertion system" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. Specifically, the term may refer to, but is not limited to, a group of at least two elements or components capable of interacting with each other to allow at least one percutaneous or subcutaneous insertion of at least one of the two elements or components into the body tissue of a subject, such as by making an incision or puncture in the subject's skin and by transferring at least one of the two elements or components completely or partially into the body tissue.

[0079] In another aspect of the invention, a method for inserting at least an insertable portion of a medical device into the body tissue of a subject is disclosed. This method includes using an insertion system as described above or which will be further described in more detail below. Therefore, for possible definitions and options, reference can be made to the disclosure of the insertion system and insertion device according to the invention.

[0080] The method includes the following steps, which may be performed in a specific order. The method may also include other method steps not listed.

[0081] The method includes the following steps: a) Apply the insertion system to the subject's skin; b) Inserting at least the insertable portion of the medical device into the body tissue of a subject, wherein the wheel is rotated upon activation by at least one torsional actuator, wherein axial movement of the insertion tool and retaining structure between a distal and proximal position is driven by the wheel, and wherein the guiding structure includes a shape having an eccentricity relative to the center of the wheel and / or relative to the rotation point of the wheel, wherein the eccentricity is not equal to zero, and wherein the shape slows down linear movement about the rotation point of the insertion tool.

[0082] The method may further include: after inserting the medical device, retracting the insertion tool from the subject's body tissue back into the insertion device.

[0083] The method of the present invention can be an in vivo method. Furthermore, the method may include steps other than those explicitly mentioned above. For example, a further step may involve, for instance, disinfecting the skin site prior to insertion. As those skilled in the art will understand, the method does not require specific medical skills and does not pose a significant health risk to the subject, and is therefore typically performed by the subject receiving the medical device themselves. Therefore, the method can be a self-administered method.

[0084] The method and apparatus according to the invention offer numerous advantages over known methods and apparatuses. The disclosed drive mechanism may include a restricted guide, guide structure, such as a guide rail or guide groove, for the insertion and retraction movement of a wheel driven by a torsional actuator. The guide structure may include a non-circular form that reduces the movement speed at the end of the insertion process and delays the retraction process. The travel of the guide rail, together with the force of the torsional actuator, can determine the speed of the insertion and retraction movements, and in particular, can make it possible to decelerate the movement of the insertion tool as it is about to change direction. The delay in retraction movement when the insertion tool is pulled out of body tissue can support the prevention of incomplete insertion of the analyte sensor. Therefore, the insertion apparatus according to the invention can significantly improve the reliability of the insertion process. Incomplete insertion of the analyte sensor can be prevented by reducing the speed of linear movement at the rotation point of the wheel. This construction can be simple and robust in use by using the same torsional actuator for the insertion and retraction movement of the retaining structure.

[0085] In summary, and without excluding other possible implementation schemes, the following implementation schemes can be envisioned: Example 1. An insertion device for inserting at least an insertable portion of a medical device into the body tissue of a subject, the insertion device comprising: - At least one housing having at least one retaining structure suitable for releasably receiving a medical device. - At least one insertion tool configured for inserting at least the insertable portion of a medical device. - At least one wheel, comprising a guide structure configured to guide the insertion tool and retaining structure for axial movement between a distal position and a proximal position, and - At least one torsion drive configured to rotate the wheel upon startup. The guide structure includes a shape with an eccentricity relative to the center of the wheel and / or relative to the rotation point of the wheel, wherein the eccentricity is not equal to zero, and wherein the shape is configured to slow down linear movement around the rotation point of the insertion tool.

[0086] Example 2. An insertion device according to the foregoing embodiments, wherein a retaining structure is configured to withdraw the insertion tool directly or indirectly from the medical device while leaving at least the inserted portion of the medical device in the body tissue.

[0087] Example 3. An insertion device according to any one of the foregoing embodiments, wherein the retaining structure is configured to directly or indirectly advance at least the insertable portion of the retaining structure and the medical device axially toward the body tissue and to insert the insertion tool and at least the insertable portion of the medical device into the body tissue.

[0088] Example 4. The insertion device according to the foregoing embodiments, wherein advancing the retaining structure is triggered by releasing the insertion locking mechanism.

[0089] Example 5. An insertion device according to any one of the foregoing embodiments, wherein the retaining structure includes at least one retaining structure guide, and wherein the housing includes at least one guide frame configured to guide axial movement of the retaining structure guide between its distal position and its proximal position.

[0090] Example 6. An insertion device according to any one of the foregoing two embodiments, wherein the insertion locking mechanism includes at least one locking arm configured to engage with a retaining structure guide to prevent the retaining structure from moving from a distal position to a proximal position.

[0091] Example 7. An insertion device according to any one of the foregoing embodiments, wherein the retaining structure includes at least one plunger.

[0092] Example 8. An insertion device according to any of the foregoing embodiments, wherein the wheel is configured to rotate in response to a rotational force applied by a torsion driver.

[0093] Example 9. An insertion device according to any one of the foregoing embodiments, wherein the torsion driver includes at least one torsion spring.

[0094] Example 10. An insertion device according to any one of the foregoing embodiments, wherein the guiding structure is a guide rail and / or a guide channel.

[0095] Example 11. An insertion device according to any one of the preceding embodiments, wherein the shape of the guide structure is selected from the group consisting of: non-circular, elliptical, spiral, and triangular.

[0096] Example 12. An insertion device according to any one of the preceding embodiments, wherein the shape of the wheel is selected from the group consisting of: circular, elliptical, non-circular, triangular, rectangular or polygonal.

[0097] Example 13. An insertion device according to any one of the foregoing embodiments, wherein the insertion device includes at least one follower, wherein a guide structure is configured to guide the follower.

[0098] Example 14. The insertion device according to the foregoing embodiments, wherein the shape of the guide structure increases the friction with the follower at the last corner position or in part.

[0099] Example 15. An insertion device according to any one of the foregoing two embodiments, wherein the follower is a follower pin, and wherein the guide structure guides the follower pin attached to the retaining structure.

[0100] Example 16. An insertion device according to any one of the foregoing embodiments, wherein the insertion device includes at least one braking element.

[0101] Example 17. An insertion device according to any one of the foregoing embodiments, wherein the insertion device includes a friction brake.

[0102] Example 18. An insertion device according to any of the preceding embodiments, wherein the insertion device includes a medical device locking mechanism configured to prevent the medical device from being pulled back into the housing when the retaining structure retracts the insertion tool from the medical device.

[0103] Example 19. An insertion device according to any of the preceding embodiments, wherein the insertion device includes an insertion locking mechanism configured to lock and release movement of a retaining structure, wherein the insertion locking mechanism is configured to interact with one or more of a wheel, a retaining structure guide, or a medical device.

[0104] Example 20. An insertion device according to any one of the foregoing embodiments, wherein the insertion tool includes at least one insertion cannula or at least one insertion needle.

[0105] Example 21. An insertion device according to the foregoing embodiments, wherein the insertion device includes a movable insertion tool protection mechanism configured to prevent the retaining structure from moving again toward the proximal position, or a movable insertion needle protection mechanism configured to prevent the retaining structure from moving again toward the proximal position.

[0106] Example 22. An insertion device according to any one of the foregoing embodiments, wherein the insertion device includes at least one protective cover, wherein the protective cover is configured to cover a skin-facing opening of the housing.

[0107] Example 23. An insertion device according to the foregoing embodiments, wherein the protective cover is removed and / or the blocking insertion locking mechanism is released.

[0108] Example 24. An insertion device according to any one of the preceding two embodiments, wherein the torsion drive is pre-tensioned at the factory or by the user, preferably by pulling down the protective cover, which then tensions the torsion drive.

[0109] Example 25. An insertion device according to any of the foregoing embodiments, wherein one or more of the housing or protective cover includes at least one desiccant.

[0110] Example 26. An insertion device according to any one of the foregoing embodiments, wherein the insertion device includes at least one user interface, such as a sound generator configured to play at least one sound when insertion has been successfully completed.

[0111] Example 27. An insertion system comprising at least one medical device and at least one insertion means according to any one of the foregoing embodiments for inserting the medical device at least partially into the body tissue of a subject, wherein the medical device is held by a retaining structure.

[0112] Example 28. An insertion system according to the foregoing embodiments, wherein the medical device includes at least one device selected from the group consisting of: an analyte sensor device; an infusion device; and an electrical stimulation device.

[0113] Example 29. An insertion system according to the foregoing embodiments, wherein the medical device further includes at least one electronic remote device configured to communicate with and / or control the medical device.

[0114] Example 30. The insertion system according to the foregoing embodiments, wherein the electronic remote device is selected from a personal computer, wearable computer, smartphone, dedicated remote control, tablet computer or server.

[0115] Example 31. A method for inserting at least an insertable portion of a medical device into the body tissue of a subject, wherein the method includes using an insertion system according to any one of the embodiments of the aforementioned insertion systems, wherein the method includes the following steps: a) Apply the insertion system to the subject's skin; b) Inserting at least the insertable portion of the medical device into the body tissue of a subject, wherein the wheel is rotated upon activation by at least one torsional actuator, wherein axial movement of the insertion tool and retaining structure between a distal and proximal position is driven by the wheel, and wherein the guiding structure includes a shape having an eccentricity relative to the center of the wheel and / or relative to the rotation point of the wheel, wherein the eccentricity is not equal to zero, and wherein the shape slows down linear movement about the rotation point of the insertion tool. Attached Figure Description

[0116] Preferably, in conjunction with the dependent claims, other optional features and embodiments will be disclosed in more detail in the following description of embodiments. These optional features, as will be recognized by those skilled in the art, can be implemented individually and in any feasible combination. The scope of the invention is not limited to the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. In these drawings, the same reference numerals refer to the same or functionally equivalent elements.

[0117] In the attached diagram: Figures 1A to 1C illustrate embodiments of a method for inserting at least an insertable portion of a medical device using an exemplary embodiment of the insertion system according to the present invention; Figures 2A to 2D illustrate embodiments of the wheels and guide structures; and Figures 3A to 3F illustrate further embodiments of the guide structure. Detailed Implementation

[0118] Figures 1A to 1C illustrate a sequence of embodiments of a method for inserting at least an insertable portion of a medical device 110 into body tissue 114 using an exemplary embodiment of the insertion system 111 according to the invention. The insertion system 111 includes at least one insertion device 112 and a medical device 110.

[0119] Medical device 110 can be any element or object configured for use in the field of medical technology, exemplarily in the fields of medical analysis or medical diagnosis. Medical device 110 can be configured to perform at least one medical function and / or be used in at least one medical procedure, such as a treatment procedure, a diagnostic procedure, or one or more other medical procedures. Medical device 114 can be configured to be mounted on a skin site of a subject's limbs. The limbs can be selected from the group consisting of: arms, exemplarily the upper arm; abdomen; shoulder; back; hip; and leg. Exemplarily, a limb can be the upper arm. However, other applications may also be feasible. Medical device 110 can include at least one component that can be configured to remain outside body tissue 114. Further, medical device 110 can include at least one insertable portion 115, such as an analyte sensor or infusion cannula or at least one electrical stimulator electrode. The insertable portion can be configured for insertion into the subject's body tissue 114. Exemplarily, an insertion device can be configured to insert the insertable portion of medical device 110 into the subject's body tissue 114. Medical device 114 may include at least one device selected from the group consisting of: analyte sensor devices, such as analyte sensor devices configured to detect at least one analyte in a subject's bodily fluids; infusion devices, such as drug infusion devices configured to infuse a liquid medication (such as insulin or any other liquid medication) into a subject's tissues; and electrical stimulation devices, such as those configured to stimulate a subject's body tissues. Such infusion devices include an infusion pump, also known as a patch pump or infusion cannula, which is attached to the patient's skin and connected via tubing to the infusion cannula to deliver medication from the pump to the skin. Known patch pumps include insulin pumps, such as Roche's Accu-Chek® Solo Micropump or Terumo's Medisafe patch pump. Known infusion cannulas include, in sequence, Roche's Accu-Chek® InsightFlex or Tandem's Diabetes AutoSoft infusion cannula or infusion cannulas manufactured by Convatec® (such as Neria Guard).

[0120] Insertion device 112 can be configured to insert at least an insertable portion of medical device 112 into body tissue 114. Insertion device 112 can be configured to insert at least an insertable portion of medical device 110 percutaneously or subcutaneously into body tissue 114, such as by making an incision or puncture in the subject's skin, and by partially transferring the medical device into the body tissue. After at least partial insertion of medical device 112 into the subject's body tissue 114, insertion device 112 can be completely or partially removed.

[0121] The insertion device 112 includes at least one housing 116 having at least one retaining structure 118 adapted to releasably receive a medical device 110. The insertion device 112 further includes at least one insertion tool 120 configured for insertion into at least an insertable portion of the medical device 112. The insertion tool 120 may be an insertion cannula. The retaining structure 118 may be configured to retain the medical device 118 and / or the retaining structure 118 may be configured to retain the insertion tool 120.

[0122] The retaining structure 118 can be configured to directly or indirectly advance the retaining structure 118 and at least the insertable portion of the medical device 110 axially toward the body tissue 114 and to insert the insertion tool 120 and at least the insertable portion of the medical device 110 into the body tissue 114. The retaining structure 118 can be configured to directly or indirectly withdraw the insertion tool 120 from the medical device 110 while leaving at least the inserted portion of the medical device 110 in the body tissue 114.

[0123] The retaining structure 118 may be, or may include, at least one plunger 122, or may be connected to at least one plunger 122 to drive the insertion tool 120 to perform a puncture or insertion movement into body tissue 114 to insert the medical device 110 and withdraw it. The plunger 122 may be configured to attach directly or indirectly, for example, via at least one additional element, to the medical device 110 and / or the insertion tool 120. The plunger 122 may be configured to directly or indirectly advance the medical device 110 axially toward the skin and insert the insertion tool (e.g., an insertion cannula) into the skin in a first stage. The plunger 122 may be configured to withdraw the insertion tool 120 from the medical device while leaving the inserted portion of the medical device 110 in the skin in a second stage.

[0124] The retaining structure 118 may include at least one retaining structure guide, such as a guide for a plunger.Figure 1A In the embodiment shown in FIG1C, the retaining structure guide is implemented as at least one guide frame 124 and at least one plunger guide 126. The plunger guide 126 may include at least one rod. A plunger 122 may be connected to the plunger guide 126. The guide frame 124 may be configured to guide axial movement of the plunger 122. Guiding may include guiding movement of the retaining structure 118. For example, the housing 116 may include the guide frame 124 configured to guide axial movement of the retaining structure guide between its distal and proximal positions.

[0125] The insertion device 112 may include at least one insertion locking mechanism 128. The insertion locking mechanism 128 may be configured to lock and release movement of the retaining structure 118. In the embodiments shown in Figures 1A-1C, the insertion locking mechanism 128 may be configured to interact with the plunger guide 126. For example, advancing the retaining structure 118 may be triggered by releasing the insertion locking mechanism 128, for example, when at least one button 130 is actuated. For example, the insertion locking mechanism 128 may be adapted to prevent unintended actuation of the insertion device 112, thereby preventing unintended actuation of the retaining structure 118. The retaining structure 118 may have a retracted position or a rest position, wherein the retaining structure 118 is stored prior to insertion and wherein the insertion tool 120 does not protrude from the insertion device 112. The insertion locking mechanism 128 may be adapted to prevent the retaining structure 118 from unintentionally leaving the rest position or stored position and / or may be adapted to generally prevent unintended actuation of the insertion device 112. The insertion locking mechanism 128 may include at least one locked position (as shown in Figures 1A and 1C) and at least one unlocked position (as shown in Figure 1B), wherein in the locked position, unwanted activation can be blocked, and wherein in the unlocked position, the insertion device 112 is activated, thereby enabling insertion of the insertable portion 115 of the medical device 110 into the body tissue 114. For example, as shown in Figure 1A, the insertion locking mechanism 128 in the locked position is adapted to at least partially block movement of the retaining structure 118 by engaging with the plunger guide 126. The insertion locking mechanism 128 may further function as a transport lock or transport safety device, for example, to prevent unwanted activation of the insertion device 112 during transport or storage. Additionally, additional transport locking devices or transport safety devices may be implemented. The insertion locking mechanism 128 may include one or more blocking elements, such as plunger locking arms as shown in Figures 1A through 1C. The plunger locking arm may include at least one hook configured to engage with the plunger guide 126 in a distal position. When button 130 is pressed, the plunger locking arm releases the plunger guide 126. For example, button 130 can apply force to the plunger locking arm, causing the hook to move outward and release the plunger guide 126. In the locked position of the insertion locking mechanism 128, where the blocked retaining structure 118 is in the retracted position shown in FIG. 1C, the user is also prevented from injuring themselves by contacting the insertion tool 120.

[0126] The insertion locking mechanism 128 can be operated manually. To operate the insertion locking mechanism 128, such as by triggering its release, the insertion locking mechanism 128 may include at least one operating element, such as a button 130. However, other types of operating elements are also possible.

[0127] The insertion tool 120 may include a tip or point for inserting a portion of a medical device, exemplarily an insertable portion 115 of medical device 110, into body tissue 114. The insertion tool 120 may include at least one insertion cannula or at least one insertion needle. During insertion, the insertion tool 120 may perform a puncture movement from a distal to a proximal position, creating an incision in the skin to transfer at least the insertable portion 115 of medical device 110 into body tissue 114, and subsequently, a movement in the opposite direction, wherein the insertion tool 120 is withdrawn from body tissue 114, wherein at least the insertable portion 115 of medical device 110 is at least partially retained within body tissue 114. During insertion, at least the insertable portion 115 of medical device 110 may be completely or partially surrounded by the insertion tool 120. As described above, the retaining structure 118 may be or may include a plunger 122 adapted to axially push the insertion tool 120 for a puncture motion and may be further adapted to axially retract the insertion tool 120 after insertion. After insertion, the insertable portion of the medical device 110, exemplarily the insertable portion 115 of the medical device 110, may remain in the subject's body tissue 114. However, after inserting at least the insertable portion 115 of the medical device 110, the insertion tool 120 may be retracted from the body tissue 114 into the insertion device 112. The insertion device 112 may include an insertion tool protection mechanism configured to prevent the retaining structure 118 from moving again toward the proximal position. In the embodiments of Figures 1A to 1C, the insertion locking mechanism 128 may serve as the insertion tool protection mechanism.

[0128] The insertion device 112 includes at least one wheel 132, which includes a guide structure 134 configured to guide axial movement of the insertion tool 120 and the retaining structure 118 between a distal position and a proximal position. The wheel 132 can be configured to apply rotational movement about an axis 136 or a center. For example, the shape of the wheel 132 can be selected from the group consisting of: circular, elliptical, non-circular, triangular, rectangular, or polygonal. The wheel 132 can be a flywheel. The wheel 132 can be a cam or a face cam.

[0129] The guide structure 134 may be at least one or more two-dimensional or three-dimensional structures configured to guide movement, such as defining the speed and / or acceleration of axial movement of the insertion tool 120 and the holding structure 118. The guide structure 134 may be a guide rail 138 and / or a guide channel 140. The guide channel 140 may include at least one groove within a surface plane of the wheel 132. The guide rail 138 may include at least one protrusion extending from a surface plane of the wheel 132. The guide structure 134 includes a shape having an eccentricity relative to the center of the wheel 132 and / or relative to the point of rotation of the wheel 132. The eccentricity is not equal to zero.

[0130] For example, the shape of the guide structure 134, for instance, in a plan view, is selected from the group consisting of: non-circular, elliptical, spiral, and triangular. For example, the shape of the guide structure 134 can be circular. Alternatively, the shape can be configured such that, although the angular movement speed of the wheel is substantially stable, the structure remains in the extended position (e.g., proximal position) for a longer time than in the case where the guide structure 134 has a strictly circular form with zero eccentricity. Compared to inserters known to date that operate at high speeds during insertion and retraction essentially throughout the entire insertion process, this design is associated with the advantage that the insertion according to the invention provides more time for the insertable portion 115 of the medical device 110 to penetrate the skin more deeply before the insertion tool 120 is pulled back: during the insertion of the insertable portion 115 of the medical device 110 into the skin, due to the inertia of the skin, the skin region adjacent to the insertion point will move away from the medical device 110, particularly when the insertion occurs at a high axial movement speed. As the speed of the insertion tool 120's axial movement around its closest point to the skin slows down, the recessed portion of the skin around the insertion point has more time to relax and move upward toward the medical device 110. This improves the insertion of the insertable portion 115 of the medical device 110, because the insertable portion 115 penetrates the skin more deeply before the axial retraction movement accelerates again to pull the insertion tool 120 out of the skin, while keeping the insertable portion 115 in place.

[0131] The insertion device 112 (e.g., wheel 132) may include at least one follower 142. The follower may be attached to the retaining structure 118. A guide structure 134 may be configured to guide the follower 142. The follower may be configured to engage with and move along the guide structure 134. For example, the follower 142 may be a follower pin, for example, moving within a guide channel 140. The follower 142 (e.g., a follower pin) may be attached to the retaining structure 118. For example, the follower 142 may be a skid or trailer that moves on a guide rail 138. The skid or trailer may be attached to the retaining structure 118. The shape of the guide structure 134 may cause friction with the follower to increase at or partially at the last corner position.

[0132] Insertion device 112 includes at least one brake element 144, as shown in FIG2, for example. At least a portion of wheel 132 can contact brake element 144 in a proximal position to retaining structure 118, such as the maximum extension position of plunger 122. Brake element 144 can be configured to slow the angular movement speed of wheel 132 within a defined angular braking interval. Once the end of the braking interval is reached, brake element 144 can stop inhibiting wheel movement, and the wheel can accelerate to retract insertion tool 120. For example, insertion device 112 can be configured such that plunger 122 stops moving or moves at a very low speed at at least one limited angular interval of wheel movement before reaching the maximum extension position to begin retraction movement. For example, the wheel diameter can be large in the angular interval where braking occurs. In this respect of wheel 132, the outer edge can contact brake element 144, resulting in slowing wheel movement. Brake element 134 can include a rod, such as a surface with high resistance, like rubber. As an addition or alternative to extending the diameter of the wheel at angular intervals, the thickness of the wheel can be locally increased such that the brake element contacts the wheel 132 only in the region of increased thickness. Additionally or alternatively, the wheel 132 may include a follower pin extending radially outward from the wheel 132 and contacting the brake element 144, such as a leaf spring. Alternatively, the follower pin may be mounted on a side of the wheel 132 and oriented perpendicular to the circular plane of the wheel 132. Control of the speed of axial movement of the insertion tool 120 and the retaining structure 118 via the brake element 144 can also be combined with control provided by a friction brake.

[0133] Figures 2A to 2D illustrate different embodiments of the wheel 132 and guide structure 134. In Figures 2A to 2D, the guide structure 134 is at least partially circular; however, it includes at least one element deviating from a circular shape. Figures 2C and 2D illustrate a coil. In principle, any shape with a non-zero eccentricity is possible. Such shapes allow for a slowing of linear movement around the rotation point of the insertion tool. Figures 3A and 3D illustrate two embodiments of the guide channel 140. In Figure 3A, on the left, a cross-sectional view of the guide channel 140 with a circular shape is shown. Figure 3A In the middle, on the right, a guide channel 140 with a rectangular shape is shown in cross-section. The corresponding follower 142 is depicted in Figure 3D. Figures 3B and 3C show embodiments of the guide rail 138, which has a circular shape in cross-section (Figure 3B, left), a rectangular shape in cross-section (Figure 3B, right), a golf tee shape in cross-section (Figure 3D, left), and a triangular shape in cross-section (Figure 3C, right). Figures 3E and 3F show the corresponding follower 142. However, other embodiments and shapes are also possible.

[0134] As further shown in Figures 1A to 1C, the insertion device includes at least one torsion driver 146 configured to rotate wheel 132 upon startup. The torsion driver 146 may include at least one torsion spring. For example, when the torsion spring is loaded, it is torsion-torsed and can apply torque in the opposite direction upon startup, thereby applying a rotational force to wheel 132. Wheel 132 is configured to rotate in response to the rotational force applied by the torsion driver 146. The torsion driver 146 (e.g., the torsion spring) may be preloaded, for example, at the factory. The torsion driver 146 (e.g., the torsion spring) may be user-loadable; for example, the torsion driver may be reloadable.

[0135] The insertion device 112 may include a medical device locking mechanism 148. As shown in Figures 1A to 1C, the medical device locking mechanism 148 may include two flexible locking arms configured to prevent the medical device 110 from being pulled back into the housing 116 when the retaining structure 118 retracts the insertion tool 120 from the medical device 110. Movement of the locking arms... Figure 1A The arrow in the image indicates this.

[0136] Figures 1A to 1C illustrate a sequence of method steps for inserting at least an insertable portion of a medical device 110 into the body tissue 114 of a subject. The method includes applying the insertion system 111 to the subject's skin. Figure 1A shows the insertion system 111 applied to the skin. The method further includes inserting at least an insertable portion of the medical device 110 into the body tissue 114 of the subject, wherein a wheel 132 is rotated upon activation by at least one torsion actuator 146. Axial movement of the insertion tool 120 and the retaining structure 118 between a distal and proximal position is driven by the wheel 132. The guide structure 134 includes a shape with an eccentricity relative to the center of the wheel 132 and / or relative to the point of rotation of the wheel 132, wherein the eccentricity is not zero. This shape slows linear movement about the point of rotation of the insertion tool 120. Figure 1B shows the insertion device 112 after activation of the torsion actuator 146, with the movement of the wheel 132 indicated by arrows. The method may further include: after inserting the medical device 110, retracting the insertion tool 120 from the subject's body tissue 114 back into the insertion device 112. Figure 1C shows the insertion device 112 after the insertion tool 120 has been retracted.

[0137] List of reference numerals

Claims

1. An insertion device (112) for inserting at least an insertable portion of a medical device (110) into body tissue (114) of a subject, said insertion device comprising: - At least one housing (116) having at least one retaining structure (118) adapted to releasably receive the medical device (110); - At least one insertion tool (120) configured for insertion into at least the insertable portion of the medical device; - At least one wheel (132) including a guide structure (134) configured to guide axial movement of the insertion tool (120) and the retaining structure (118) between a distal position and a proximal position; and - At least one torsion actuator (146) configured to rotate the wheel (132) upon startup. The guide structure (134) includes a shape having an eccentricity relative to the center of the wheel (132) and / or relative to the rotation point of the wheel (132), wherein the eccentricity is not equal to zero, and wherein the shape is configured to slow down linear movement around the rotation point of the insertion tool (120).

2. The insertion device (112) according to the preceding claim, wherein the retaining structure (118) is configured to withdraw the insertion tool (120) directly or indirectly from the medical device (110) while leaving at least the inserted portion of the medical device (110) in the body tissue (114).

3. The insertion device (112) according to any one of the preceding claims, wherein the retaining structure (118) is configured to directly or indirectly advance the retaining structure (118) and at least the insertable portion of the medical device (110) axially toward the body tissue (114) and to insert the insertion tool (120) and at least the insertable portion of the medical device (110) into the body tissue (114).

4. The insertion device (112) according to the preceding claim, wherein advancing the retaining structure (118) is triggered by releasing the insertion locking mechanism (128).

5. The insertion device (112) according to any one of the preceding claims, wherein the retaining structure (118) includes at least one retaining structure guide, wherein the housing (116) includes at least one guide frame (124) configured to guide axial movement of the retaining structure guide between its distal position and its proximal position.

6. The insertion device (112) according to any one of the preceding claims, wherein the retaining structure (118) includes at least one plunger (122).

7. The insertion device (112) according to any one of the preceding claims, wherein the wheel (132) is configured to rotate in response to a rotational force applied by the torsion drive (146).

8. The insertion device (112) according to any one of the preceding claims, wherein the torsion driver (146) comprises at least one torsion spring.

9. The insertion device (112) according to any one of the preceding claims, wherein the guide structure (134) is a guide rail (138) and / or a guide channel (140).

10. The insertion device (112) according to any one of the preceding claims, wherein the shape of the guide structure (134) is selected from the group consisting of: non-circular, elliptical, spiral and triangular.

11. The insertion device (112) according to any one of the preceding claims, wherein the insertion device (112) includes at least one follower (142), wherein the guide structure (134) is configured to guide the follower (142).

12. The insertion device (112) according to any one of the preceding claims, wherein the insertion device (112) includes at least one brake element (144) and / or wherein the insertion device (112) includes a friction brake.

13. An insertion system (111) comprising at least one medical device (110) and at least one insertion means (112) for inserting said medical device (110) at least partially into body tissue (114) of a subject, according to any of the preceding claims, wherein said medical device (110) is held by said holding structure (118).

14. The insertion system (111) according to the preceding claim, wherein the medical device (110) comprises at least one means selected from the group consisting of: an analyte sensor means; an infusion means; and an electrical stimulation means.

15. The insertion system (111) according to the preceding claim, wherein the medical device (110) further comprises at least one electronic remote device configured to communicate with and / or control the medical device.

16. The insertion system (111) according to the preceding claim, wherein the electronic remote device is selected from a personal computer, a wearable computer, a smartphone, a dedicated remote control, a tablet computer, or a server.

17. A method for inserting at least an insertable portion of a medical device (110) into body tissue (114) of a subject, wherein the method includes using an insertion system (111) according to any one of the preceding claims, wherein the method includes the steps of: a) Apply the insertion system (111) to the subject's skin; b) Inserting at least an insertable portion of the medical device (110) into the body tissue (114) of the subject, wherein the wheel (132) is rotated upon activation by the at least one torsion actuator (146), wherein axial movement of the insertion tool (120) and the retaining structure (118) between the distal and proximal positions is driven by the wheel (132), and wherein the guide structure (134) includes a shape having an eccentricity relative to the center of the wheel (132) and / or relative to the rotation point of the wheel (132), wherein the eccentricity is not equal to zero, and wherein the shape slows down linear movement about the rotation point of the insertion tool (120).

Images