WO2025186150A1

WO2025186150A1 - Inserter attachment device

Info

Publication number: WO2025186150A1
Application number: PCT/EP2025/055635
Authority: WO
Inventors: Olaf Roscher
Original assignee: Roche Diabetes Care GmbH
Current assignee: Roche Diabetes Care GmbH
Priority date: 2024-03-05
Filing date: 2025-03-03
Publication date: 2025-09-12
Anticipated expiration: 2026-09-05
Also published as: WO2025186150A8

Abstract

An inserter attachment device (116) for temporarily attaching an insertion system (110) to a skin of a subject for at least the duration of an insertion of at least one insertable part of a medical device into a body tissue of the subject is disclosed. The inserter attachment device (116) comprises a frame element (118) having an attachment side (120) comprising at least one adhesive structure (122) configured for releasably attaching to the skin of the subject, wherein an adhesive strength of the adhesive structure (122) is such that the attachment is released when the insertion system (110) is lifted from the skin of the subject after the insertion is completed. Further disclosed are an insertion system (110) and a method of inserting at least one insertable part of a medical device into a body tissue of a subject.

Description

Inserter Attachment Device

Technical Field

The invention relates to an inserter attachment device for temporarily attaching an insertion system to a skin of a subject for at least the duration of an insertion of at least one insertable part of a medical device into a body tissue of the subject. The invention further relates to an insertion system and a method for inserting at least one insertable part of a medical device into a body tissue of a subject. The medical device may specifically be configured for detecting at least one analyte in a body fluid of the subject. The inserter attachment device, the insertion system and the method may be applied in the field of continuous monitoring of the analyte in the body fluid of the subject, specifically in the field of home care and in the field of professional care, such as in hospitals. Other application, however, are feasible.

Background art

Monitoring certain body functions, more particularly monitoring one or more analyte concentrations such as one or more metabolite concentrations in a body fluid of a subject plays an important role in the prevention and treatment of various diseases. Such analytes can by way of example, but not exclusively, include glucose, lactate, cholesterol or other types of analytes and metabolites. Without restricting further possible application, the invention will be described in the following text with reference to glucose monitoring. However, additionally or alternatively, the invention can also be applied to other types of analytes.

Blood glucose monitoring, besides by using optical measurements, specifically may be performed by using electrochemical biosensors. In addition to so-called spot measurements, in which a sample of a body fluid is taken from a used in a targeted fashion and is examined with respect to the analyte concentration, continuous measurements are increasingly becoming established. Thus, in the recent past, continuous measuring of interstitial tissue (also referred to as continuous monitoring, CM) for example, has been established as another important method for managing, monitoring and controlling a diabetes state.

In the process, an active sensor region is applied directly to a measurement site, which is generally arranged in an interstitial tissue, and, for example, converts glucose into electrical charge by using an enzyme (e.g. glucose oxidase, GOD) the charge of which is related to the glucose concentration and can be used as a measurement variable. Examples of such transcutaneous measurement systems are described in US 6,360,888 Bl or in US 2008/0242962 Al.

Hence, current continuous monitoring systems typically are transcutaneous systems or subcutaneous systems. This means that the sensor or at least a measuring portion of the sensor is arranged under the skin of the user. However, an evaluation and control part of the insertion system (also referred to as a patch) is generally situated outside of the body of the subject, e.g. outside of the human or animal body. In the process, the medical device is generally applied using an insertion instrument. For the insertion process to be successful, it is generally beneficial to limit relative movement between the insertion instrument and the skin of the user during the process. Thus, in order to forego such relative movement, typically, a base, which may later house the evaluation and control part of the insertion system, e.g. as part of the patch, is typically applied at the insertion site before starting the insertion process.

CA 2 828 873 C describes an infusion device that includes one or more of automatic insertion and retraction of an introducer needle and catheter, introducer needle safety arid extension set. The device can further comprise a top-push button activation feature, a side-push button activation feature or a rotary-button activation feature, and one or more of a manual interlock of an outer barrel and base, and a manual interlock for an extension set top and base. Packaging for an integrated and/or removable inserter with activation button protection is also disclosed.

US 10,933,191 B2 describes a single package infusion set, including one or more of the following inserters: pushbutton-type, squeeze-type, contact -type, skin pinching -type, folding retraction-type, or multistage-type inserter having at least one reusable stage. The infusion set further includes adhesion means with user-selectable degrees of adhesion strength, selfsealing tube connection means, a lens feature to view, a site beneath the set, exemplary tube management and connection elements, insulin supply, adhesion concealment means, finger loops on the inserter and site preparation wipes or sprays, optionally provided as part of the inserter. The system further includes a package, which may hold a number of easily released sets, retrievable by an inserter, an exemplary insertion needle handle and shroud, an exemplary squeeze-type latch between an upper portion and a lower portion of the set, and/or a tool removable upper portion of the set.

US 11,197,627 B2 describes a continuous glucose monitoring system and method that has an inserter assembly for inserting a sensor through the skin and into subcutaneous tissue where an inserter housing with the sensor remains on the skin after insertion, a sensor housing cover attachable to the sensor housing after insertion where the sensor housing cover has an electronic module and a battery, and an electronic device equipped with wireless communication for communicating with the electronic module of the sensor housing cover assembly, the electronic device is configured for receiving input signals from the sensor, converting the input signals to analyte date, displaying the analyte data on a user interface of the electronic device, storing the data for recall, and creating and/or sending reports of the data.

US 10,881,340 B2 describes an apparatus for insertion of a medical device in the skin of a subject, as well as methods of inserting medical devices. Further solutions are known from US 2022/225899 Al and WO 2023/013871 Al.

Despite the advantages provided for by known devices and methods, still several technical challenges remain. Specifically, there is a continuing need for improving the handling of insertion systems to increase user convenience without compromising safety and measurement accuracy.

Problem to be solved

It is therefore desirable to provide an inserter attachment device for temporarily attaching an insertion system to a skin of a subject for at least the duration of an insertion of at least one insertable part of a medical device into a body tissue of the subject, as well as an insertion system and a method for inserting at least one insertable part of a medical device into a body tissue of a subject. Specifically, conveniently usable devices, systems and methods are desirable which require a minimum amount of handling steps, while still allowing for a reliable insertion of at least the insertable part of the medical device into the body tissue of the subject.

Summary This problem is addressed by an inserter attachment device, an insertion system and a method with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

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

Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

In a first aspect of the present invention, an inserter attachment device for temporarily attaching an insertion system to a skin of a subject for at least the duration of an insertion of at least one insertable part of a medical device into a body tissue of the subject is disclosed. The inserter attachment device comprises a frame element having an attachment side comprising at least one adhesive structure configured for releasably attaching to the skin of the subject. Specifically, the adhesive structure may be configured for releasably attaching the inserter attachment device to the skin of the subject. An adhesive strength of the adhesive structure is such that the attachment is released when the insertion system is lifted from the skin of the subject after the insertion is completed. For example, the adhesive strength of the adhesive structure is selected to be such that the attachment is released, i.e. the inserter attachment device detaches from the skin of the subject, when the insertion system is lifted from the skin of the subject after the insertion is completed, i.e. after the medical device is inserted into the body tissue of the subject.

The present invention may allow for a convenient and reliable insertion, since the adhesive structure may prevent a relative movement, specifically a sliding movement, between the inserter attachment device and the skin of the subject, particularly during the insertion process, while allowing for an easy and quick detachment of the inserter attachment device from the skin of the subject, when lifted, e.g. pulled upwards, from the skin. In particular, the adhesive strength of the adhesive structure parallel to an adhesive surface may be strong enough to prevent a tilting and/or sliding movement, while at the same time the adhesive strength perpendicular to the adhesive surface and/or a peeling strength may be weak enough to release the attachment between the inserter attachment device and the skin when the user lifts the inserter attachment device from the skin.

The term “subject” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a human being or an animal, independent from the fact that the human being or animal, respectively, may be in a healthy condition or may suffer from one or more diseases. The subject may be a patient. As an example, the subject may be a human being or an animal suffering from diabetes. The subject may be a user, e.g. a patient, intending to monitor an analyte value, such as a glucose value, in the user’s body tissue and/or to deliver medication, such as insulin, into the user’s body tissue. However, in an embodiment, the user of the insertion device may be different from the subject. Additionally or alternatively, the invention may be applied to other types of users or patients.

The term “medical device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element or article being configured for use in the field of medical technology, exemplarily in the field of medical analytics or medical diagnostics. The medical device may be configured for performing at least one medical function and/or for being used in at least one medical process, such as one or more of a therapeutic process, a diagnostic process or another medical process.

The medical device may be configured to be mounted on a skin site, such as a skin site of an extremity of the subject. The extremity may be selected from the group consisting of an arm, exemplarily an upper arm; a stomach; a shoulder; a back; a hip; a leg. Exemplarily, the extremity may be the upper arm. However, also other applications may be feasible. The medical device may comprise at least one component, which may be configured to stay outside of the body tissue. Further, the medical device may comprise at least one insertable portion. The insertable portion may be configured for being inserted into the body tissue of the subject. Exemplarily, the inserter attachment device may be configured for temporarily attaching an insertion system, configured for inserting the insertable portion of the medical device into the body tissue of the subject, to a skin, specifically to at least one skin site, of the subject for at least the duration of the insertion of the at least one insertable part of the medical device into the body tissue of the subject.

The medical device may comprise at least one device selected from the group consisting of an analyte sensor device, e.g. an analyte sensor device configured for detecting at least one analyte in a body fluid of the subject; an infusion device, e.g. a drug infusion device configured for infusing a liquid drug such as insulin or any other liquid drug into a tissue of the subject; and an electrical stimulating device, e.g. configured for stimulating a body tissue of the subject. Such infusion devices include infusion pumps that can be attached to the skin of a patient also known as patch pumps or infusion sets that are connected to an infusion pump often worn in the pocket of a patient and connected to the infusion set by a tubing to deliver the drug from the pump into the skin. Known patch pumps include insulin pumps such as Roche’s Accu-Chek® Solo Micropump or Terumo’s Medisafe patch pump. Known infusion sets, in turn, include Roche’s Accu-Chek® Insight Flex or Tandem’s Diabetes AutoSoft Infusion set or the infusion sets manufactured by Convatec® such as Neria Guard.

For example, the medical device may comprise at least one analyte sensor device. The analyte sensor device may comprise at least one analyte sensor configured for detecting at least one analyte in a body fluid of the subject. The insertion tool of the insertion device may be configured for inserting at least a part of the analyte sensor into the body tissue of the subject, e.g. at least one insertable portion. The term “analyte sensor device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device configured for detecting at least one analyte in a body fluid of the subject.

The term “analyte” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a chemical and/or biological substance which takes part in the metabolism of the body of the subject. Exemplarily, the analyte may be a metabolite or a combination of two or more metabolites. As an example, the analyte may be selected from the group consisting of glucose, lactate, triglycerides, cholesterol. A preferred analyte is glucose. Still, other analytes or combinations of two or more analytes may be detected. The body tissue exemplarily may be or may comprise fatty tissue and/or interstitium. Other types of body tissue, however, are feasible.

The analyte sensor may be configured for being used in qualitatively and/or quantitatively detecting the at least one analyte. The term “analyte sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a sensor which is capable of qualitatively or quantitatively detecting the presence and/or the concentration of the at least one analyte. The analyte sensor may be an electrochemical analyte sensor. Additionally or alternatively, the analyte sensor may be an optical sensor. Other embodiments of the analyte sensor may be possible.

The term “body fluid” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary fluid which typically is present in a body or body tissue of a user or a patient and/or which may be produced by the body of the user or the patient. As an example for body tissue, interstitial tissue may be named. Thus, as an example, the body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids may be used, such as saliva, tear fluid, urine or other body fluids. During detection of at least one analyte, the body fluid may be present within the body or body tissue. The term “inserting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an action or process of one or more of transcutaneously or subcutaneously implanting and/or positioning the medical device, exemplarily the insertable portion of the medical device, into the body tissue of the subject. The medical device may partially be inserted into the body tissue. The insertion of the medical device may be performed by using the insertion system as outlined below. After insertion, at least an insertable part of the medical device may remain in the body tissue of the subject for a predetermined period of time, such as for several hours, exemplarily for one or more days, such as for up to one week, or such as for up to two weeks or even more.

The term “insertion system” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to a system configured for inserting at least the insertable part of the medical device into the body tissue. The insertion system may be configured for transcutaneously or subcutaneously inserting at least the insertable part of the medical device into the body tissue, such as by performing an incision or a puncture in a skin of the subject and by transferring the medical device partially into the body tissue. The insertion system may be removed fully or partially after inserting the medical device at least partially into the body tissue of the subject leaving the medical device in place.

Specifically, the inserter attachment device is fully removed, e.g. together with the rest of the insertion system, after inserting the medical device at least partially into the body tissue of the subject.

The term “inserter attachment device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device configured for temporarily attaching the insertion system to a skin site of the subject for at least the duration of the insertion, specifically during inserting, of the at least one insertable part of the medical device into the body tissue of the subject. The inserter attachment device may specifically be a part of the insertion system as will be outlined in further detail below. As outlined above, the inserter attachment device comprises at least one frame element having an attachment side comprising at least one adhesive structure configured for releasably attaching to the skin of the subject.

The term “frame element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary carrier configured for providing mechanical stability, for example to the at least one adhesive structure comprised by the attachment side of the frame element. The frame element may have an open or a closed form, such as a shape consisting of one or more parts, specifically to fully or partially enclose and/or encircle an insertion area, such as an area of the skin on the subject where the insertable part of the medical device is to be inserted into the body tissue. Thus, as an example, the frame element may be configured to fully surround the insertion area. In particular, the frame element may have a cross section, specifically a cross section parallel to the skin of the subject, completely encircling and/or enclosing the insertion area. Alternatively, the frame element may be configured to only partially surround the insertion area, such as by the cross section of the frame element having regularly or irregularly spaced interceptions. As an example, the intercepted cross section of the frame element may surround at least 50% of the insertion area.

The frame element, specifically depending on its height, such as on its extension in a direction perpendicular to the skin of the subject, may comprise a rigid and/or firm material or may comprise a flexible and/or pliable material. As an example, in case the frame element’s height is below a height threshold th, the frame element may be made of or may comprise a flexible, soft and/or elastic material, such as one or more materials selected from the group consisting of rubber, such as latex; paper; and viscose, such as a viscose fabric. In case the frame element’s height is equal to or above the height threshold th, the frame element may be or may comprise a rigid and/or firm object comprising at least one brittle, unyielding and/or inflexible material, such as one or more materials selected from the group consisting of a thermoset; and a thermoplastic, such as Polyvinyl chloride.

The height threshold th may be in the range of from 0 mm to 3 mm. Specifically, 0.01 mm < th < 2.5 mm. More specifically 0.05 mm < th < 2 mm.

The term “attachment side” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a surface of the frame element of the inserter attachment device facing the skin of the subject, specifically during the insertion. In particular, the attachment side may be the side of the frame element of the inserter attachment device facing the skin site of the subject into which the insertable part of the medical device is to be inserted.

The term “adhesive structure” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary adhesive material comprising element, configured for establish an adhesive connection on contact. In particular, the adhesive structure may be or may comprise at least one glue configured for establishing a releasable adhesive connection with the skin of the subject when physically contacting the skin, optionally assisted by an applied pressure.

In particular, the adhesive structure may comprise at least one adhesive layer, such as a strip and/or patch. The adhesive layer may be limited, e.g. in its outline, to the coupling side of the frame element. Thus, as an example, the surface, specifically the whole surface, of the adhesive layer may be attachable to the skin of the subject, by pressing the frame element, with its attachment side facing the skin, onto the skin of the subject.

Alternatively, the adhesive layer may comprise at least one adhesive layer, such as a strip and/or patch, protruding from at least one edge of the attachment side. As an example, the adhesive layer may protrude from the edge of the attachment side, such as by protruding beyond an outline of the frame element, by at least 0.3. Specifically, the adhesive layer may protrude from the edge of the attachment side by at least 0.5 cm. In particular, the adhesive layer may protrude at least such that a finger can be used to press the at least one protruding part of the adhesive layer to the skin of the subject for attaching the surface of the protruding part of the adhesive layer to the skin. For example, the adhesive layer may protrude beyond the outline of the frame element of the attachment side, such that by at least partially sliding around the outer edge of the inserter attachment device, the finger can press the at least one protruding part of the adhesive layer to the skin of the subject, thereby attaching the surface of the protruding part of the adhesive layer to the skin.

The adhesive structure may specifically be connected to the frame element by an adhesive connection. Additionally or alternatively, the adhesive structure may be connected to the frame element by an ultrasound welding connection, such as by a connection established by performing at least one ultrasound welding process. In particular, a force that is transmittable via the connection, specifically one or both of the adhesive connection and the ultrasound welding connection, may be higher than the adhesive strength developable between the adhesive structure and the skin of the subject. For example, the connection between the adhesive structure and the frame element may be configured for withstanding a higher pull force, such as a force in a direction essentially perpendicular to the skin of the subject, than the adhesive connection establishable between the adhesive structure and the skin of the subject, such as the connection developable by pushing the adhesive structure onto the skin of the subject.

As used herein, the term “essentially perpendicular” is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an angle of about 90°, specifically to an angle within the range of from 50° to 130°, more specifically within the range of from 80° to 100°, more specifically within the range of from 85° to 95°. In particular, an essentially perpendicular direction may refer to a direction that is essentially right-angled to a reference plane and/or surface, such as to a direction along a straight line that is at an angle a to the reference plane and/or surface, wherein 50 < a < 130°, specifically 80 < a < 100°, more specifically 85 < a < 95°.

The inserter attachment device may further comprise at least one coupling side arranged opposite the attachment side. Specifically, the coupling side may be or may refer to a surface of the frame element arranged opposite to the attachment side. The term “coupling side” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a surface of the frame element of the inserter attachment device facing away from the skin of the subject, specifically during the insertion. In particular, the coupling side may be the side of the frame element of the inserter attachment device facing away from the skin site of the subject into which the insertable part of the medical device is to be inserted. In particular, the coupling side may be arranged on a side of the frame element facing a housing of the insertion system.

The coupling side may comprise at least one coupling structure configured for connecting to at least one side of the insertion system, such as to at least one side of the housing of the insertion system. The term “coupling structure” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary connector or connection element, configured for establishing a connection between two objects. In particular, the coupling structure may be or may comprise a form-fit, force-fit and/or material-fit connection. As an example, the coupling structure may be or may comprise at least one mechanical coupling, e.g. establishing a reversible or irreversible mechanical connection. Therein, “reversible connection” may refer to a non- destructively reversible connection, while “irreversible connection” may refer to a connection reversible only by at least partially breaking one or more of the two objects. Additionally or alternatively, the coupling structure may be or may comprise at least one material coupling, such as by using one or more intermediate materials, e.g. an adhesive or glue.

As an example, a force transmittable via the coupling structure, e.g. in a direction essentially perpendicular to the skin of the subject, may be higher than the adhesive strength of the adhesive structure, i.e. of the adhesive strength developable between the adhesive structure and the skin of the subject.

As an example, the coupling structure may be a coupling comprising one or more of a bayonet coupling, a snap-fit coupling, a screw coupling, and an adhesive coupling.

The term “bayonet coupling” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a connector or connection between two bayonet contours in a bayonet fashion. The bayonet coupling may be formed by two bayonet contours. A bayonet contour of the coupling structure and a bayonet contour of a counterpart, such as on the insertion system, e.g. on a housing of the insertion system, in conjunction may form the bayonet coupling. Thus, when referring to the coupling side comprising a bayonet coupling, it may actually mean that the coupling side of the frame element of the inserter attachment device comprising at least one bayonet contour, while the counterpart bayonet contour may be comprised and/or arranged on at least one side of the housing of the insertion system.

The term “bayonet contour” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a component or part of an element, which is configured to interact with a counterpart bayonet contour in order to form a bayonet coupling or bayonet joint. The bayonet coupling may also be referred to as bayonet joint. In particular, one of the bayonet contours, either the coupling structure bayonet contour or the counterpart bayonet contour, may be or may comprise a male bayonet contour, such as a male bayonet plug. The respective other one of the two bayonet contours may be or may comprise female bayonet contour, such as a female bayonet plug. Therein, generally, one or both of the bayonet contours involved may comprise at least one protrusion and, in a complementary fashion, the other one of the bayonet contours may comprise at least one bayonet groove or bayonet slot in which the protrusion may be guided.

The bayonet groove or bayonet slot generally may comprise at least two different sections. In a first section, the protrusion may simply be moved in an axial fashion, with respect to an axis, which interconnects the two bayonet contours. Thus, as an example, while the protrusion is guided in the first section, the two components and/or objects, which will be interconnected by the bayonet coupling, simply may be pushed together along the axis. In a second section, which directly or indirectly may follow the first section, the protrusion may be guided in a spiral or screwlike fashion around the axis. The bayonet groove or bayonet slot may comprise one or more further sections, such as one or more sections before the first section, one or more intermediate sections in between the first section and the second section and/or one or more sections behind the second section. Combinations of the named sections are feasible. Thus, as an example, the connection of the coupling structure to the at least one side of the insertion system, such as to at least one side of the housing of the insertion system, may be formed and/or established by a sequence of movements or relative movements of the two components, such as a first linear movement along an axis and, subsequently, a rotational movement about the axis. Thus, generally, the establishing of a releasable mechanical bayonet connection may imply a combination of an axial movement and a rotational movement, in a subsequent fashion, with preferably the axial movement preceding the rotational movement. The axis, as an example, may be a rotational axis of the bayonet contour, such as an axis of symmetry of the bayonet joint. The rotational movement or tilting, as an example, may take place about a tilting angle, from an initial angle to a final angle, wherein, in the position of the final angle, as an example, the inserter attachment device is connected to the at least one side of the insertion system, i.e. to the at least one side of the housing of the insertion system. The tilting angle, for example, may be an angle in the range of 10° to 130°, such as an angle of 20° to 110°, preferably an angle of 25° to 90°, more preferably an angle of 30°. When releasing the bayonet joint, the movements may be performed in the opposite order.

The term “snap-fit coupling” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a connector or connection between two snap-fit contours in a snap-fit fashion. The snap-fit coupling, similar to the bayonet coupling, may be formed by two snap-fit contours. A snap- fit contour of the coupling structure and a snap -fit contour of a counterpart, such as on the insertion system, e.g. on a housing of the insertion system, in conjunction may form the snap-fit coupling. Thus, when referring to the coupling side comprising a snap-fit coupling, it may actually mean that the coupling side of the frame element of the inserter attachment device comprising at least one snap-fit contour, while the counterpart snap-fit contour may be comprised and/or arranged on at least one side of the housing of the insertion system.

The “snap-fit contour” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a component or part of an element, which is configured to interact with a counterpart snap -fit contour in order to form a snap-fit coupling or snap-fit joint. The snap-fit coupling may also be referred to as snap-fit joint. In particular, one of the snap-fit contours, either the coupling structure snap-fit contour or the counterpart snap-fit contour, may be or may comprise a male snap-fit contour, such as a male snap-fit plug. The respective other one of the two snap-fit contours may be or may comprise female snap-fit contour, such as a female snap-fit plug. Therein, generally, one or both of the snap-fit contours involved may comprise at least one undercut and, in a complementary fashion, the other one of the snap-fit contours may comprise at least one snap-fit recess in which the undercut may be guided and locked. The term “undercut”, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary convexity arranged at a surface of the snap-fit contour Specifically the undercut may be and/or may comprise a protrusion, such as, for example, a protrusion having a pencil shaped form, a tooth shaped form or a jagged form, configured to lock into the recess of the counterpart snap -fit contour. The snap-fit coupling may be established by both of the complementary snap-fit contours being pushed together along an axis. Thus, as an example, the two components and/or objects, which will be interconnected by the snap -fit coupling, simply may be moved in an axial fashion, sliding them together until the undercut is locked in the snap-fit recess, e.g. by one or both of the snap-fit contours performing an elastic deformation. Specifically, the axial movement, as an example, may continue until the undercut, i.e. the protrusion, snaps into the recess, thereby locking the snap-fit coupling.

The term “screw coupling” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a connector or connection between two screw contours in a rotational fashion. In particular, the screw coupling may be formed by both the coupling side of the inserter attachment device and the at least one side of the insertion system, e.g. the at least one side of the housing of the insertion system, comprising a thread, screwed together by performing a helical movement, thereby establishing a screw connection.

The term “adhesive coupling” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a connection established by using an arbitrary adhesive material for establishing an adhesive connection. In particular, the adhesive coupling may be established by one or more of a glue adhesively interconnecting the coupling side of the inserter attachment device and the at least one side of the insertion system, e.g. the at least one side of the housing of the insertion system.

The frame element, and optionally also the adhesive structure, may have a central opening, e.g. a through hole and/or a bore through the center of gravity and/or through the geometric center of the frame element. In particular, the frame element may thus enclose and/or encircle an interior of the hole and/or bore. As an example, the interior of the hole and/or bore may, at least in size, correspond to the insertion area as described above. For example, the frame element may have a ring shape. Specifically, the frame element may have a cross section of a closed ring shape, such as the shape of an area between two concentric circles or ovals, e.g. a circular ring shape or an oval ring shape. Additionally or alternatively, the frame element may have a cross section of an open ring shape, such as the shape of one or more circular or oval ring segments. Additionally or alternatively, the frame element may have a cross section of a closed rectangular ring shape, such as the shape of an area between two concentric rectangles or squares. Additionally or alternatively, the frame element may have a cross section of an open rectangular ring shape, such as the shape of an intercepted area between two concentric rectangles, e.g. at least two L-shapes or at least four I-shapes. Additionally or alternatively, the frame element may have a cross section of a closed triangular ring shape, such as the shape of an area between two concentric triangles. Additionally or alternatively, the frame element may have a cross section of an open triangular ring shape, such as an intercepted area between two concentric triangles, e.g. at least three V-shapes or at least three I-shapes.

In particular, in case the frame element has a central opening, the adhesive structure, specifically the adhesive layer, may also have a central opening. The central opening of the frame element may specifically be large enough to provide room for the component of the medical device configured to stay outside of the body tissue, e.g. for a sensor patch. For this purpose, the central opening may have an opening area having a size in the range of from 0.3 cm² to 30 cm². Specifically, the central opening may have an opening area having a size in the range of from 0.5 cm² to 20 cm². More specifically, the central opening may have an opening area having a size in the range of from 0.9 cm² to 15 cm².

In a further aspect of the present invention, an insertion system configured for inserting at least one insertable part of a medical device into a body tissue of a subject is disclosed. The insertion system comprises: an insertion tool configured for inserting the insertable part of the medical device; at least one housing at least partially enclosing the insertion tool; an inserter attachment device according to present invention as disclosed herein, specifically as disclosed above or as further described below.

For possible definitions and options of the insertion system, reference is made to the disclosure of the inserter attachment device according to the present invention.

The term “housing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an element or component having at least one interior space and at least one wall fully or partially surrounding the at least one interior space and providing protection to the interior space, specifically to the insertion tool at least partially enclosed within the housing, such as one or more of a mechanical protection and a protection against environmental influences such as one or more of moisture, oxygen and microbial contaminations. The housing may generally be adapted to fully or partially surround and/or receive one or more elements, such as but not limited to the insertion tool, in order to provide one or more of a mechanical protection, a mechanical stability, an environmental protection against moisture and/or ambient atmosphere, a shielding against electromagnetic influences or the like. The housing may also provide a basis for attachment and/or holding one or more further components or elements.

As outlined above, the insertion system comprises the at least one insertion tool configured for inserting at least an insertable part of the medical device. The term “insertion tool” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically relates to an arbitrary element which may be insertable at least partially into the body tissue, particularly in order to deliver or to transfer a further element. The insertion tool may be configured for supporting the insertion of the insertable part of the medical device. Exemplarily, the insertion tool may be configured for supporting the insertion of the insertable portion of the medical device. The insertion tool may comprise a tip or a sharp end for inserting the insertable part of the medical device, exemplarily the insertable portion of the medical device, into the body tissue. In the context of the present invention, the insertion tool is considered as part of the insertion system. However, in particular during manufacturing of an insertion system the insertion tool may also be considered as an insertable part of the medical device. Thus, during insertion, the insertion tool may perform a puncture motion creating an incision in a skin of a user or patient, transferring at least the insertable part of the medical device into the body tissue, and, subsequently may be pulled out from the body tissue, wherein at least the insertable part of the medical device at least partially remains within the body tissue. During insertion, at least the insertable part of the medical device may fully or partially be surrounded by the insertion tool. After insertion, the insertable part of the medical device may remain in the body tissue of the subject. The insertion tool, however, may be retracted from the body tissue of the subject back into the insertion system after inserting the medical device.

The insertion tool may comprise at least one insertion cannula or at least one insertion needle. The term “insertion cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow needle which may be at least partially slotted such as in U shape, triangular shape, ellipsoid shape or round shape. At least the insertable part of the medical device may be received within the insertion cannula, such as within a lumen of the insertion cannula. The term “insertion needle” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a compact needle, exemplarily without a slot and without any hollow parts. The medical device such as a soft cannula of an infusion set of a patch pump may be received on an outer surface of the insertion needle.

The inserter attachment device and the housing may for example be integrally formed, such that the inserter attachment device and the housing are one integrally formed part. Alternatively, the inserter attachment device and the housing may be coupled to each other. Specifically, the inserter attachment device and the housing may be coupled to each other by the coupling structure of the inserter attachment device for at least the duration of the insertion of the at least one insertable part of the medical device into the body tissue of the subject.

As an example, in case the coupling structure is one or more of the bayonet coupling, the snap-fit coupling, and the screw coupling, the housing may comprise the at least one counterpart to the coupling for connecting to the inserter attachment device. Thus, in case the coupling structure is the bayonet coupling, the housing may comprise the counterpart bayonet contour to the bayonet contour of the coupling structure of the inserter attachment device. Further, in case the coupling structure is the snap-fit coupling, the housing may comprise the counterpart snap-fit contour to the snap-fit contour of the coupling structure of the inserter attachment device. Furthermore, in case the coupling structure is the screw coupling, the housing may comprise a thread configured to be threaded with, e.g. screwed into or onto, the thread of the coupling structure of the inserter attachment device.

In a further aspect of the present invention, a method of inserting at least one insertable part of a medical device into a body tissue of a subject is disclosed. The method comprises using the insertion system as described above or as will further be described below. Thus, for possible definitions and options, reference may be made to the disclosure of the insertion system and the inserter attachment device according to the present invention.

The method comprises the following steps, which specifically me be performed in the given order. The method may comprise further method steps that are not listed.

The method comprises the following steps: a) providing an insertion system according to the present invention as disclosed herein, specifically as disclosed above or as further described below; b) attaching the inserter attachment device of the insertion system to a skin of the subject by placing the attachment side on the skin, and specifically by applying pressure; c) inserting, by the insertion tool, the insertable part of the medical device into the body tissue of the subject; d) lifting the insertion system from the skin of the subject, thereby detaching the inserter attachment device from the skin of the subject.

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

In case the inserter attachment device comprises a coupling structure, e.g. as specifically outlined above with regard to the inserter attachment device, step a) of the method may further comprise connecting the inserter attachment device to the housing. Specifically, in case step a) comprises connecting the inserter attachment device to the housing, step b) may be performed after the inserter attachment device is connected to the housing. In particular, step b) may be performed after step a). Alternatively, specifically in case step a) comprises connecting the inserter attachment device to the housing, step b) may be performed before the inserter attachment device is connected to the housing. In particular, step b) may be performed before step a) or at least partially overlapping with step a).

Further, specifically after performing step d), the method may comprise the following step: e) separating the inserter attachment device from the housing.

As an example, and depending on the coupling structure, step e) may comprise decoupling the attachment device from the housing by at least partially breaking the inserter attachment device, e.g. the coupling structure of the inserter attachment device.

In case the adhesive structure comprises at least one protruding adhesive layer, e.g. as specifically outlined above with regard to the inserter attachment device, step b) of the method may further comprise, e.g. by using a finger, pressing the at least one protruding part of the adhesive layer to the skin of the subject, thereby attaching the surface of the protruding part of the adhesive layer to the skin.

The method and devices according to the present invention provide a large number of advantages over known methods and devices. The disclosed inserter attachment device, specifically by the adhesive structure attaching to the skin of the subject, may allow for an easy positioning of the inserter system at an arbitrary part of the subject’s body, e.g. on an arbitrary site of the human or animal body. Specifically, the adhesive structure may allow the subject and/or user to position the inserter system with only one hand and by requiring less handling steps than known inserter systems and methods.

Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged: Embodiment 1 : An inserter attachment device for temporarily attaching an insertion system to a skin of a subject for at least the duration of an insertion of at least one insertable part of a medical device into a body tissue of the subject, the inserter attachment device comprising a frame element having an attachment side comprising at least one adhesive structure configured for releasably attaching, specifically the inserter attachment device, to the skin of the subject, wherein an adhesive strength of the adhesive structure is such that the attachment is released, e.g. the inserter attachment device detaches from the skin of the subject, when the insertion system is lifted from the skin of the subject after the insertion is completed, i.e. after the medical device is inserted into the body tissue of the subject while the insertable part of the medical device remains in the body tissue of the subject.

Embodiment 2: The inserter attachment device according to the preceding embodiment, wherein the adhesive structure comprises at least one adhesive layer, such as a strip and/or patch.

Embodiment 3 : The inserter attachment device according to the preceding embodiment, wherein the adhesive layer is either limited, e.g. in its outline, to the coupling side of the frame element or protrudes from at least one edge of the attachment side.

Embodiment 4: The inserter attachment device according to the preceding embodiment, wherein the adhesive layer protrudes from the edge of the attachment side by at least 0.3 cm, specifically at least 0.5 cm, such that a finger, e.g. by sliding around at least one outer edge of the inserter attachment device, can be used to press the at least one protruding part of the adhesive layer to the skin of the subject for attaching a surface of the protruding part of the adhesive layer to the skin.

Embodiment 5 : The inserter attachment device according to any one of the preceding embodiments, wherein the adhesive structure is connected to the frame element by an adhesive connection or by an ultrasound welding connection, such as a connection established by ultrasound welding, wherein a force transmittable via the connection is higher than the adhesive strength developable between the adhesive structure and the skin of the subject.

Embodiment 6: The inserter attachment device according to any one of the preceding embodiments, further comprising at least one coupling side arranged opposite the attachment side, comprising at least one coupling structure configured for connecting to at least one side of the insertion system, wherein a force transmittable via the coupling structure, e.g. in a direction essentially perpendicular to the skin of the subject, is higher than the adhesive strength of the adhesive structure, i.e. of the adhesive strength developable between the adhesive structure and the skin of the subject.

Embodiment 7 : The inserter attachment device according to the preceding embodiment, wherein the coupling structure is a coupling comprising one or more of a bayonet coupling, a snap-fit coupling, a screw coupling, and an adhesive coupling.

Embodiment 8: The inserter attachment device according to any one of the preceding embodiments, wherein the frame element, and optionally the adhesive structure, has a central opening, e.g. a through hole and/or a bore through the center of gravity and/or through the geometric center of the frame element.

Embodiment 9: The inserter attachment device according to the preceding embodiment, wherein the frame element has a cross section of one or more of a closed ring shape, such as the shape of an area between two concentric circles or ovals, specifically a circular ring shape or an oval ring shape; an open ring shape, such as the shape of one or more circular or oval ring segments; a closed rectangular ring shape, such as the shape of an area between two concentric rectangles or squares; an open rectangular ring shape, such as the shape of an intercepted area between two concentric rectangles, e.g. at least two L-shapes or at least four I-shapes; a closed triangular ring shape, such as the shape of an area between two concentric triangles; an open triangular ring shape, such as an intercepted area between two concentric triangles, e.g. at least three V-shapes or at least three I-shapes.

Embodiment 10: The inserter attachment device according to any one of the two preceding embodiments, wherein the central opening has an opening area having a size in the range of from 0.3 cm² to 30 cm², specifically in the range of from 0.5 cm² to 20 cm², more specifically in the range of from 0.9 cm² to 15 cm².

Embodiment 11 : An insertion system configured for inserting at least one insertable part of a medical device into a body tissue of a subject, comprising an insertion tool configured for inserting the insertable part of the medical device; at least one housing at least partially enclosing the insertion tool; an inserter attachment device according to any one of the preceding embodiments. Embodiment 12: The insertion system according to the preceding embodiment, wherein the inserter attachment device and the housing are integrally formed, such that the inserter attachment device and the housing are one integrally formed part; or coupled to each other, specifically by the coupling structure of the inserter attachment device according to any one of embodiments 6 and 7, for at least the duration of the insertion of the at least one insertable part of the medical device into the body tissue of the subject.

Embodiment 13: The insertion system according to the preceding embodiment, wherein in case the coupling structure is one or more of the bayonet coupling, the snap-fit coupling, and the screw coupling, the housing comprises at least one counterpart to the coupling for connecting to the inserter attachment device.

Embodiment 14: A method of inserting at least one insertable part of a medical device into a body tissue of a subject, the method comprising: a) providing an insertion system according to any one of the preceding embodiments referring to an insertion system; b) attaching the inserter attachment device of the insertion system to a skin of the subject by placing the attachment side on the skin, and specifically by applying pressure; c) inserting, by the insertion tool, the insertable part of the medical device into the body tissue of the subject; d) lifting the insertion system from the skin of the subject, thereby detaching the inserter attachment device from the skin of the subject.

Embodiment 15 : The method according to the preceding embodiment, wherein in case the inserter attachment device comprises a coupling structure, specifically according to any one of embodiments 6 and 7, step a) further comprises connecting the inserter attachment device to the housing, wherein step b) is performed after the inserter attachment device is connected to the housing, i.e. step b) is performed after step a), or step b) is performed before the inserter attachment device is connected to the housing, i.e. step b) is performed before step a) or at least partially overlapping with step a).

Embodiment 16: The method according to the preceding embodiment, further comprising: e) separating the inserter attachment device from the housing. Embodiment 17: The method according to any one of the preceding method embodiments, wherein in case the adhesive structure comprises at least one protruding adhesive layer, specifically according to any one of embodiments 3 and 4, step b) further comprises, e.g. by using a finger, pressing the at least one protruding part of the adhesive layer to the skin of the subject, thereby attaching the surface of the protruding part of the adhesive layer to the skin.

Short description of the Figures

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

In the Figures:

Figures 1 to 3 show an embodiment of an insertion system in a perspective view (Figure 1), in a sectional sectional view (Figure 2) and in a bottom view (Figure 3);

Figure 4 shows an embodiment of an insertion system in a perspective view;

Figures 5 and 6 show an embodiment of an inserter attachment device in a perspective view (Figure 5) and in a top view (Figure 6);

Figures 7 and 8 show an embodiment of an inserter attachment device in a perspective view (Figure 7) and in a top view (Figure 8); and

Figures 9 and 10 show flow charts of a method of inserting at least one insertable part of a medical device into a body tissue of a subject.

Detailed description of the embodiments Figures 1 to 3 show an embodiment of an insertion system 110 configured for inserting at least one insertable part of a medical device into a body tissue of a subject. The insertion system 110 comprises an insertion tool 112 configured for inserting the insertable part of the medical device and at least one housing 114 at least partially enclosing the insertion tool 112. Further, the insertion system 110 comprises an inserter attachment device 116 for temporarily attaching the insertion system to a skin of the subject for at least the duration of the insertion of the at least one insertable part of the medical device into the body tissue of the subject.

The housing 114 and the inserter attachment device 116 may be integrally formed, such that the inserter attachment device 116 and the housing 114 are one integrally formed part. Such an embodiment may exemplarily be illustrated in Figures 1 to 3. Alternatively, the inserter attachment device 116 and the housing 114 may be coupled to each other. Such an embodiment may exemplarily be illustrated in Figure 4.

The inserter attachment device 116 comprises a frame element 118 having an attachment side 120 comprising at least one adhesive structure 122 configured for releasably attaching to the skin of the subject. An adhesive strength of the adhesive structure 122 is such that the attachment is released when the insertion system 110 is lifted, e.g. in an essentially perpendicular direction, from the skin of the subject, specifically after the insertion is completed. The adhesive structure 122 may specifically comprise at least one adhesive layer protruding from at least one edge 124 of the attachment side 120. In particular, the adhesive layer may protrude from the at least one edge 124 enough such that the protruding part of the adhesive layer can be pressed to the skin of the subject by sliding around at least one outer edge of the inserter attachment device, e.g. by sliding around the edge 124 of the attachment side 120. In particular, by pressing the adhesive layer to the skin, a surface of the protruding part of the adhesive layer touching the skin of the subject may be attached to the skin of the subject.

The inserter attachment device 116 may comprise a coupling side 126 arranged opposite the attachment side 120. The coupling side 126 may specifically comprising at least one coupling structure 128 configured for connecting to at least one side of the insertion system 110. Specifically, the coupling structure 128 may be configured to connect to at least one side of the housing 114, such as a skin-facing side 130 of the housing 114 configured to face the skin of the subject. In particular, a force transmittable via the coupling structure 128, e.g. in a direction essentially perpendicular to the skin of the subject, may be higher than the adhesive strength of the adhesive structure 122, i.e. of the adhesive strength developable between the adhesive structure 122 and the skin of the subject.

Specifically, the at least one coupling structure 128 may comprise at least one snap-fit coupling 132. Such an embodiment of the inserter attachment device 116 may exemplarily be illustrated in Figures 4 to 6. The snap-fit coupling 132 may specifically be configured to establish a connection between the housing 114 and the inserter attachment device 116 by pushing a snap-fit contour 134 of the inserter attachment device 116 and a snap-fit contour 134 of the housing 114, specifically arranged on the skin-facing side 130, together until an undercut and a snap-fit recess of the snap-fit contours 134 interlock. In particular, the inserter attachment device 116 may be pushed towards the housing 114 of the insertion system 110 in a direction of the arrow exemplarily illustrated in Figure 4.

Additionally or alternatively, the at least one coupling structure 128 may comprise at least one bayonet coupling 136. Such an embodiment of the inserter attachment device 116 may exemplarily be illustrated in Figures 7 and 8. The bayonet coupling 136 may for example be configured for establishing a connection between the housing 114 and the inserter attachment device 116 by a sequencial relative movement of the housing 114 and the inserter attachment device 116. In particular, a first linear movement along an axis 138 of the inserter attachment device 116 may be followed by a rotational movement about the axis 138 to establish the connection between the inserter attachment device 116 and the rest of the insertion system 110 via the bayonet coupling 136. In particular, similar to the function of the snap-fit coupling 132, the bayonet coupling 136 may be established by interacting contours, such as by two interaction bayonet contours 140. Additionally or alternatively, further coupling structures 128, such as a screw coupling and/or an adhesive coupling are also feasible.

In particular, the frame element 118 may have a central opening 142, such as a cut out large enough for a component of the medical device configured to stay outside of the body tissue, e.g. for a sensor patch, to fit through. The central opening 142 may have a round and/or circular shape, as exemplarily illustrated in Figures 1 to 8. However, other shapes are feasible, such as an arbitrary shape, for example in the form of a triangle, a rectangle, a square or a combination thereof.

Figures 9 and 10 illustrate flow charts of a method of inserting at least one insertable part of a medical device into a body tissue of a subject. The method comprises the following steps: a) (denoted by reference number 144) providing an insertion system 110 according to the present invention; b) (denoted by reference number 146) attaching the inserter attachment device 116 of the insertion system 110 to a skin of the subject by placing the attachment side 120 on the skin, and specifically by applying pressure; c) (denoted by reference number 148) inserting, by the insertion tool 112, the insertable part of the medical device into the body tissue of the subject; d) (denoted by reference number 150) lifting the insertion system 110 from the skin of the subject, thereby detaching the inserter attachment device 116 from the skin of the subject.

As an example, in case the inserter attachment device 116 comprises a coupling structure 128, step a) of the method may further comprise connecting the inserter attachment device 116 to the housing 114, e.g. by the coupling structure 128.

Further, the method may comprise the following step: e) (denoted by reference number 152) separating the inserter attachment device (116) from the housing (114).

As a further example, in case the adhesive structure 122 comprises at least one protruding adhesive layer, step b) of the method may further comprise, e.g. by using a finger, pressing the at least one protruding part of the adhesive layer to the skin of the subject, thereby attaching the surface of the protruding part of the adhesive layer to the skin.

Specifically, the adhesive structure 122 may comprise the protruding adhesive layer only on an outer side of the frame element 118, e.g. protruding from the attachment side 120 only towards an outer sider of the frame element 118. Such an embodiment of the inserter attachment device 116 may exemplarily be illustrated in Figure 6. Alternatively, the adhesive structure 122 may comprise the protruding adhesive layer on both an inner side and on an outer side of the frame element 118, e.g. protruding from the attachment side 120 both inwards and outwards an outer sider of the frame element 118. Such an embodiment of the inserter attachment device 116 may exemplarily be illustrated in Figures 3 and 8. List of reference numbers

110 insertion system

112 insertion tool

114 housing

116 inserter attachment device

118 frame element

120 attachment side

122 adhesive structure

124 edge

126 coupling side

128 coupling structure

130 skin-facing side

132 snap-fit coupling

134 snap-fit contour

136 bayonet coupling

138 axis

140 bayonet contour

142 central opening

144 step a)

146 step b)

148 step c)

150 step d)

152 step e)

Claims

1. An inserter attachment device (116) for temporarily attaching an insertion system (110) to a skin of a subject for the duration of an insertion of at least one insertable part of a medical device into a body tissue of the subject, the inserter attachment device (116) comprising a frame element (118) having an attachment side (120) comprising at least one adhesive structure (122) configured for releasably attaching to the skin of the subject, wherein an adhesive strength of the adhesive structure (122) is such that the attachment is released when the insertion system (110) is lifted from the skin of the subject after the medical device is inserted into the body tissue of the subject and the insertion is completed, wherein the insertable part of the medical device remains in the body tissue of the subject for a predetermined period of time.

2. The inserter attachment device (116) according to the preceding claim, wherein the adhesive structure (122) comprises at least one adhesive layer protruding from at least one edge (124) of the attachment side (120).

3. The inserter attachment device (116) according to the preceding claim, wherein the adhesive layer protrudes from the edge (124) of the attachment side (120) by at least 0.3 cm, such that a finger can be used to press the at least one protruding part of the adhesive layer to the skin of the subject for attaching a surface of the protruding part of the adhesive layer to the skin.

4. The inserter attachment device (116) according to any one of the preceding claims, wherein the adhesive structure (122) is connected to the frame element (118) by an adhesive connection or by an ultrasound welding connection, wherein a force transmittable via the connection is higher than the adhesive strength developable between the adhesive structure (122) and the skin of the subject.

5. The inserter attachment device (116) according to any one of the preceding claims, further comprising at least one coupling side (126) arranged opposite the attachment side (120), comprising at least one coupling structure (128) configured for connecting to at least one side of the insertion system, wherein a force transmittable via the coupling structure (128) is higher than the adhesive strength of the adhesive structure (122).

6. The inserter attachment device (116) according to the preceding claim, wherein the coupling structure (128) is a coupling comprising one or more of a bayonet coupling (136), a snap-fit coupling (132), a screw coupling, and an adhesive coupling.

7. The inserter attachment device (116) according to any one of the preceding claims, wherein the frame element (118) has a central opening (142).

8. The inserter attachment device (116) according to the preceding claim, wherein the frame element (118) has a cross section of one or more of a closed ring shape; an open ring shape; a closed rectangular ring shape; an open rectangular ring shape; a closed triangular ring shape; and an open triangular ring shape.

9. An insertion system (110) configured for inserting at least one insertable part of a medical device into a body tissue of a subject, comprising an insertion tool (112) configured for inserting the insertable part of the medical device; at least one housing (114) at least partially enclosing the insertion tool (112); an inserter attachment (116) device according to any one of the preceding claims.

10. The insertion system (110) according to the preceding claim, wherein the inserter attachment device (116) and the housing (114) are integrally formed, such that the inserter attachment device (116) and the housing (114) are one integrally formed part; or coupled to each other for at least the duration of the insertion of the at least one insertable part of the medical device into the body tissue of the subject.

11. The insertion system (110) according to the preceding claim, wherein in case the coupling structure (128) is one or more of the bayonet coupling (136), the snap-fit coupling (132), and the screw coupling, the housing (114) comprises at least one counterpart to the coupling for connecting to the inserter attachment device (116).

12. A method of inserting at least one insertable part of a medical device into a body tissue of a subject, the method comprising: a) providing an insertion system (110) according to any one of the preceding claims referring to an insertion system (110); b) attaching the inserter attachment device (116) of the insertion system (110) to a skin of the subject by placing the attachment side (120) on the skin; c) inserting, by the insertion tool (112), the insertable part of the medical device into the body tissue of the subject; d) lifting the insertion system (110) from the skin of the subject, thereby detaching the inserter attachment device (116) from the skin of the subject, wherein the insertable part of the medical device remains in the body tissue of the subject for a predetermined period of time.

13. The method according to the preceding claim, wherein in case the inserter attachment device (116) comprises a coupling structure (128), step a) further comprises connecting the inserter attachment device (116) to the housing (114), wherein step b) is performed after the inserter attachment device (116) is connected to the housing (114), or step b) is performed before the inserter attachment device (116) is connected to the housing (114).

14. The method according to the preceding claim, further comprising: e) separating the inserter attachment device (116) from the housing (114).

15. The method according to any one of the preceding method claims, wherein in case the adhesive structure (122) comprises at least one protruding adhesive layer, step b) further comprises pressing the at least one protruding part of the adhesive layer to the skin of the subject, thereby attaching the surface of the protruding part of the adhesive layer to the skin.