Insertion device and method for inserting a medical device
Patent Information
- Application Number
- CA3324636
- Authority / Receiving Office
- CA · CA
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-05-14
- Filing Date
- 2025-05-12
- Publication Date
- 2025-11-20
AI Technical Summary
Existing insertion systems for medical devices, such as analyte sensors, require significant handling force and pose a risk of accidental triggering, compromising user convenience and safety during insertion into body tissue.
An insertion device with a resistance pairing mechanism, comprising a latch arm and resisting member, provides controlled insertion by requiring a manageable actuation force while preventing unintentional actuation, allowing for safe and convenient one-handed operation.
The device ensures safe and controlled insertion of medical devices with minimal handling force, reducing the risk of accidental triggering and enhancing user convenience.
Abstract
Description
[0001] Insertion device and method for inserting a medical device
[0002] Technical Field
[0003] The invention relates to an insertion device, and 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 insertion device 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 applications, however, are also feasible.
[0004] Background art
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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. Typically, for arranging the sensor under the skin, an insertion instrument is used. Such insertion instruments are generally known.
[0009] US 11,510,625 B2 describes applicators of on-skin sensor assemblies for measuring an analyte in a host, as well as their method of use and manufacture. In some aspects, an applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes an applicator housing, a needle carrier assembly comprising an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly, and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position, and from the distal insertion position to a proximal retraction position.
[0010] US 8,801,611 B2 describes systems and methods for measuring an analyte in a host. More particularly, to systems and methods for transcutaneous measurement of glucose in a host.
[0011] EP 4248 860 Al describes an insertion device for at least partially inserting a medical device such as an analyte sensor through the skin of a subject. The insertion device has a proximal end to be put in contact with the skin and a distal end opposite to the proximal end. The insertion device comprises: a guide sleeve being provided at the proximal end and to be placed in contact with the skin for an insertion process; a cap being provided at distal end, which can be pressed on to carry out at least part of the insertion process while moving in the direction of the proximal end; an inserter sleeve provided at least partially within the guide sleeve and / or the cap and being provided with a holder for the medical device and the inserter sleeve being moveable with respect to the guide sleeve; a retractor configured to retract a portion provided with the medical device, the retractor being moveable along a movement path, an elastic element such as a spring, which can bias the retractor towards the distal end along the movement path; a retractor control element which controls the movement of the retractor by blocking or freeing the movement of the retractor along the movement path and which is itself moveable such as rotatable with respect to the retractor. The invention further refers to an insertion system and an insertion method. 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.
[0012] Problem to be solved
[0013] It is therefore desirable to provide an insertion device and an insertion system for inserting at least one insertable part of a medical device into a body tissue of a subject along an insertion axis as well as 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 force, while at the same time minimizing the risk of accidental triggering, thus still allowing for a safe and controlled insertion of at least the insertable part of the medical device into the body tissue of the subject.
[0014] Summary
[0015] This problem is addressed by an insertion device, an insertion system and a method for inserting at least one insertable part of a medical device into a body tissue of a subject 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] In a first aspect of the present invention, an insertion device for inserting at least one insertable part of a medical device into a body tissue of a subject along an insertion axis is disclosed.
[0020] 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. As an example, when a person, such as medical staff, applies, e.g. uses, the insertion device, for inserting at least one insertable part of the medical device into a patient, then the person, e.g. medical staff, is referred to as “user”, while the patient is referred to as “subject”. Nevertheless, herein, the terms “user” and ’’subject” may be used interchangeably.
[0021] 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.
[0022] For example, the medical device may be or may comprise at least one analyte sensor for detecting at least one analyte in a bodily fluid of the subject, such as in a bodily fluid contained in a body tissue of the subject.
[0023] The analyte sensor may be configured for being used in qualitatively and / or quantitatively detecting the at least one analyte. 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. Specifically, the analyte may be a metabolite or a combination of two or more metabolites. As an example, the analyte may be selected from the group consisting of glucose, lactate, triglycerides, cholesterol. Still, other analytes or combinations of two or more analytes may be detected. The body tissue specifically may be or may comprise fatty tissue and / or interstitium. Other types of body tissue, however, are feasible.
[0024] 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.
[0025] The analyte sensor may be an electrochemical analyte sensor. The analyte sensor may comprise at least two electrodes. Specifically, the analyte sensor may comprise at least one two- electrode sensor. The two-electrode sensor may comprise precisely two electrodes, such as a working electrode and at least one further electrode such as a counter electrode, in particular a working electrode and a combined counter / reference electrode. The working electrode may comprise a working electrode pad and, optionally, at least one test chemical disposed thereon. The counter electrode may comprise a conductive electrode pad. Additionally and optionally, one or more redox materials may be disposed thereon. The analyte sensor may further comprise one or more leads for electrically contacting the electrodes. The leads may, during insertion or at a later point in time, be connected to an electronics unit, such as one or more measurement devices adapted for measuring electrical currents and / or electrical voltages, such as to one or more potentiostats. Preferably, the leads already connected to the electronics unit before insertion of the analyte sensor.
[0026] Specifically, the analyte sensor may be a strip-shaped analyte sensor having a flexible substrate and the electrodes disposed thereon. As an example, the analyte sensor may have a total length of 5 mm to 50 mm, specifically a total length of 7 mm to 30 mm. The term “total length” within the context of the present invention relates to the overall length of the analyte sensor which means the portion of the analyte sensor which is inserted and the portion of the analyte sensor which is connected to the electronics unit. The portion of the analyte sensor which is inserted is also called the in-vivo portion, the portion of the analyte sensor which is connected to the electronics unit is also called the ex vivo portion. Preferably, the in vivo portion has a length in the range from 3 mm to 12 mm.
[0027] The analyte sensor may further comprise a biocompatible cover, such as a biocompatible membrane which fully or partially covers the analyte sensor, and which prevents the test chemical from migrating into the body tissue and which allows for a diffusion of the bodily fluid and / or the analyte to the electrodes.
[0028] Other embodiments of electrochemical analyte sensors, such as three-electrode sensors, may be feasible. For example, the three-electrode sensor may comprise, in addition to the working electrode and the counter electrode, a reference electrode.
[0029] In another embodiment, the analyte sensor may be an optical analyte sensor. For example, the analyte sensor may comprise a flexible light guide with glucose sensitive coating at its end and / or a tube like carrier with functional elements at inner or outer walls. Other embodiments of the analyte sensor may be possible too. For potential embodiments of analyte sensors, reference may be made to the above-mentioned prior art documents.
[0030] 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 at least the insertable part of the medical device into the body tissue of the user. The medical device, such as the analyte sensor, may fully or partially be inserted into the body tissue. The insertion of the medical device may be performed by using the insertion device. After insertion, the medical device or at least a 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, specifically for one or more days, more specifically for up to one week, even more specifically for up to two weeks or even more. The medical device may be configured for continuously monitoring and / or detecting the analyte in the body fluid of the subject.
[0031] The term “insertion device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device configured for inserting at least the insertable part of the medical device into the body tissue. The insertion device may be configured for transcutaneously or subcutaneously inserting 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 fully or partially into the body tissue. The insertion device may be removed fully or partially after inserting the medical device at least partially into the body tissue of the subject.
[0032] The insertion device comprises an insertion tool. Further, the insertion device comprises a cap. Furthermore, the insertion device comprises at least one insertion sleeve and at least one guide sleeve configured for guiding the insertion sleeve therein. The insertion sleeve and / or the cap in conjunction with the guide sleeve form at least one resistance pairing comprising at least one latch arm and at least one resisting member, wherein at least one of the insertion sleeve and the cap comprises at least one of the at least one latch arm and the at least one resisting member of the resistance pairing and wherein the guide sleeve comprises at least one other of the at least one latch arm and the at least one resisting member of the resistance pairing. For inserting the at least one insertable part of the medical device, the cap, the insertion tool and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position. The cap is movable from its distal position to its proximal position by an actuation force parallel to the insertion axis, wherein the actuation force is greater than a resistance force provided by the resistance pairing in response to the actuation force.
[0033] Thus, as an example, the at least one resistance pairing may be formed, in conjunction, by the insertion sleeve and the guide sleeve. Additionally or alternatively, the at least one resistance pairing may be formed, in conjunction, by the cap and the guide sleeve.
[0034] The present invention may allow for a convenient and safe insertion, since the at least one resistance pairing, by providing the resistance force, may prevent accidental and / or unintentional actuation of the insertion device, thereby reducing the risk of an unintentional insertion of the at least one insertable part of the medical device. Furthermore, the resistance pairing may allow for an intentional actuating of the insertion device, e.g. for a purposeful insertion of the at least one insertable part of the medical device, by the subject, for example a one- handed handling of the insertion device, by allowing the insertion device to be actuated and / or used by applying a conveniently low and manageable actuation force, such as an inserter release force. Specifically, the insertion sleeve and / or the cap in conjunction with the guide sleeve, in particular the at least one latch arm and the at least one resisting member of the insertion sleeve and / or the cap and the guide sleeve respectively, forming the at least one resistance pairing, may allow for a high enough resistance to prevent unintentional insertion, while still allowing easy, e.g. one-handed, actuating of the insertion device for intended insertion.
[0035] 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 may refer, without limitation, to an arbitrary object or 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 at least the insertable part of the medical device, specifically when driven from its distal position to its proximal position. The insertion tool may comprise a tip or a sharp end for inserting the medical device into the body tissue. The insertion tool may be or may comprise an insertion cannula or an 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. The medical device may be received within the insertion cannula, such as within a lumen of the insertion cannula. The term “insertion needle” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a compact needle, specifically without a slot and without any hollow parts. The medical device may be received on an outer surface of the insertion needle.
[0036] After insertion, 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 into the insertion device after inserting the medical device, specifically the at least one insertable part of the medical device. For retracting the insertion tool the insertion device may comprise an insertion tool retractor.
[0037] The term “insertion tool retractor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one element of the insertion device configured for retracting the insertion tool. The insertion tool retractor may be configured for suspending the insertion tool during insertion movement and pull it out from the skin of the subject, specifically after the insertion, in a retraction movement. As an example, the insertion tool retractor may be configured for retracting the insertion tool from the body tissue of the subject when driven from its proximal position to its distal position, specifically to its distal retraction position.
[0038] The term “cap” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary shaped element configured for fully or partially enclosing one or more components of the insertion device and / or for providing protection for these one or more components, such as against mechanical influence and / or humidity. The cap may surround and / or may enclose fully or partially one or more further components, such as the insertion tool, e.g. the insertion tool retractor, the insertion sleeve and the guide sleeve, specifically the insertion sleeve and / or the cap and the guide sleeve forming, in conjunction, the at least one resistance pairing. The term “at least partially surround”, also referred to as “at least partially enclose”, 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 embodiments wherein the cap fully surrounds the one or more further components of the insertion device and to embodiments wherein the cap may surround at least a part of the one or more further components. For example, the cap of the insertion device may fully surround the insertion sleeve, the insertion tool and optionally the insertion tool retractor. The cap may also at least partially surround the guide sleeve and, thus, may fully cover the guide sleeve except for a proximal end of the guide sleeve. The cap may be arranged such that it surrounds and / or encloses the further components of the insertion device, wherein a proximal side of the insertion device may be at least partially uncovered by the cap allowing contacting the subject’s skin with the guide sleeve and movement of the insertion tool out of the insertion device, i.e. through the subject’s skin and into the subject’s body tissue. The cap when being in the proximal position may align with the proximal end of the guide sleeve. The proximal side may be the side of the insertion device providing a contact area or region with the subject’s skin. A distal side may be a side of the insertion device opposite to the proximal side.
[0039] The cap may be or may comprise a rigid cap, such as a rigid cap made of one or more of a plastic material, a metallic material or a cardboard material.
[0040] The cap specifically may be essentially rotationally symmetric, e.g. by having an axial rotational symmetry about an axis such as a cylinder axis or axis of extension, specifically around the insertion axis. The term “essentially rotationally symmetric” 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 the fact that the cap may be fully rotationally symmetric or may comprise at least one part being rotationally symmetric, whereas other parts of the cap may exhibit a form diverging from the rotational symmetry. The cap may be designed as a cylinder, a hemisphere or as a dome. The cap may comprise an inner structure, which may not be rotationally symmetric. An outer shape of the cap may also be asymmetrical, e.g. may be shaped ergonomically to be held by a user’s hand. The inner structure of the cap may correspond to an outer shape and / or structure of the insertion sleeve. For example, the inner structure of the cap may be cylindrical or prismatic.
[0041] Further, the cap may be configured for interacting with and / or holding at least one other component of the insertion device together. Specifically, the cap may be configured to transfer movement onto at least one other component of the insertion device, such as onto one or more of the insertion tool and the insertion sleeve and optionally the insertion tool retractor. Thus, as an example, by the movement of the cap from its distal position to its proximal position also the insertion tool and the insertion sleeve and optionally the insertion tool retractor may be moved from their respective distal positions to their respective proximal positions.
[0042] The term “insertion sleeve” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element configured for at least partially enclosing the insertion tool. The insertion sleeve itself may be enclosed fully or partially by the guide sleeve and the cap of the insertion device.
[0043] The insertion sleeve may be prismatic. The insertion sleeve may be essentially rotationally symmetric, specifically in accordance with the symmetry of the cap and the guide sleeve. For example, the cap and the guide sleeve may have an axial rotational symmetry about an axis such as a cylinder axis or axis of extension, the insertion sleeve may have a similar axial rotational symmetry. The insertion sleeve may be configured for guiding the insertion tool and / or the insertion tool retractor. For example, for guiding a cylindrical-shaped insertion tool retractor, the insertion sleeve may comprise a rotational symmetric hollow center. The rest of the insertion sleeve may have an irregular cross section.
[0044] The term “guide sleeve” 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 enclosure of one or more components configured for guiding at least one movement of the enclosed components. The guide sleeve may fully or partially enclose the insertion tool retractor and / or the insertion sleeve. The guide sleeve may be partially enclosed by the cap.
[0045] The guide sleeve may be essentially rotationally symmetric, specifically in accordance with the symmetry of the cap of the insertion device, in particular of the inner structure of the cap of the insertion device. For example, in case the cap may have an axial rotational symmetry about an axis such as a cylinder axis or axis of extension, the guide sleeve may have a similar axial rotational symmetry.
[0046] The guide sleeve may be movable with respect to the cap of the insertion device. For example, when using the insertion device, the guide sleeve may be configured for sliding into the cap of the insertion device. The guide sleeve, in particular the proximal end of the guide sleeve, may be in contact with the user’s skin when the insertion device is used.
[0047] Further, the guide sleeve may be movable with respect to the insertion sleeve and may be configured for guiding the insertion sleeve within its inner space. For example, when using the insertion device, the movement of the cap may drive a movement of the insertion sleeve, wherein the direction of the movement of the insertion sleeve may be guided by the guide sleeve, e.g. by an inner surface of the guide sleeve, for example along the insertion axis. Specifically, the guide sleeve may prevent the insertion sleeve from performing a tilting movement in response to the movement of the cap.
[0048] In conjunction, the guide sleeve and one or more of the insertion sleeve and the cap form at least one resistance pairing. The resistance pairing comprises at least one latch arm and at least one resisting member. The term “latch arm” 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 lever angularly protruding from at least one surface of an element. The latch arm may be deformable, specifically elastically deformable. The latch arm may comprise at least one fixed end, where the lever is fixed to the surface of the element, for example to the guiding sleeve or one of the insertion sleeve and the cap. Further, the latch arm may comprise at least one free end, directed towards the other one of the guiding sleeve and one of the insertion sleeve and the cap, respectively. In particular, the latch arm, specifically the free end of the latch arm may engage the resisting member once in at least one position during the insertion device’s transition from the distal position to the proximal position. The term “resisting member” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a physical obstacle arranged at a surface of an element, such as a cavity and / or indentation in at least one surface of an element or to a protrusion from a surface of an element. The resisting member may specifically be configured to temporarily block and / or deflect a movement of another object and / or element gliding on the surface of the element on which the resisting member is located and / or from which the resisting member protrudes. In particular, the resisting member, specifically the cavity or protrusion, may be configured to engage with the free end of the latch arm.
[0049] The term “engage” and / or “engaging” as used herein with regard to the resistance pairing, specifically with regard to the latch and the resisting member, 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 locking process in which two elements physically contact each other in a form fit connection in at least two directions. In particular, the free end of the latch arm and the resisting member may be or may comprise complementary shapes and may thus engage by a form fit connection. For example, in case the resisting member comprises an indentation or concavity, the free end of the latch arm may protrude into the indentation or cavity and may thus engage the resisting member by a form fit connection. Alternatively, in case the resisting member comprises a protrusion, the free end of the latch arm, specifically at a side of the free end facing away from the latch arm’s fixed end, may rest against the protrusion, specifically at a transition from the surface of the element from which the resisting member protrudes and the protrusion itself, thereby engaging the resisting member by a form fit connection.
[0050] In particular, the latch arm, wherein engaging the resisting member, may be in a relaxed state. Thus, when the latch arm and the resisting member are engaged, the latch arm may specifically be in a non-deflected state. As an example, in the relaxed state, specifically in the non-deflected state, no tensions may occur within the latch arm due to deformation. Thus, in the relaxed state, no deformation of the latch arm may occur. In particular, the latch arm may be free of inner stress or strain.
[0051] The term “resistance pairing” 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 at least two-piece interaction mechanism configured to provide detectable resistance to a user when actuating and / or using the insertion device. In particular, the resistance pairing may be configured for providing a resistance force in reaction to the two pieces, specifically the latch arm and the resisting member, being forcefully moved against each other. Specifically, the resistance pairing may provide the resistance force in a direction along the insertion axis, when the insertion sleeve is moved from its distal position to its proximal position within the guide sleeve or when the cap is moved from its distal position to its proximal position with respect to the guide sleeve, in particular along the insertion axis. The resistance force may for example be overcome by applying a force greater than the resistance force, e.g. the actuation force, in a direction parallel to the insertion axis, thereby disengaging the latch arm from the resisting member. In particular, the latch arm may disengage from the resisting member by performing a deformation, such as by transitioning into a deflected state. As an example, by deforming, the latch arm may “overcome” the obstacle that is the resisting member.
[0052] The resistance force of the resistance pairing may for example be defined by an elasticity of the latch arm and at least one angle of the resisting member. In particular, the form or shape as well as the material properties of the latch arm and of the resisting member may dictate or define the resistance force of the resistance pairing and thus also a minimum required actuation force.
[0053] For inserting the at least one insertable part of the medical device, the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor are movable relative to the guide sleeve from the distal position to the proximal position, by applying the actuation force onto the cap. From the distal position to the proximal position, the resistance force, provided by the resistance pairing formed by the guide sleeve and one of the insertion sleeve and the cap in a direction parallel to the insertion axis, has to be overcome by the actuation force. During the actuation, the guide sleeve may be regarded as a fix or non-moving component of the insertion device since the guide sleeve is positioned on the subject’s skin. The other components, such as the insertion tool, the insertion sleeve, the cap and optionally the insertion tool retractor may move in a proximal direction, e.g. along the insertion axis, relative to the skin of the subject and relative to the guide sleeve.
[0054] The term “distal position” 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 position specification indicating a position of the insertion device and / or any parts thereof in relation to the subject in which the insertion tool and / or the cap are furthermost from the proximal side of the insertion device. Specifically, for inserting the medical device, the insertion device may be brought into contact with a skin site of the subject. The distal position may refer to a position being distanced to the skin site of the subject. Specifically, the distal position may refer to a most distanced position with regard to the skin site of the subject. The distal position may be an initial position prior to the insertion movement of the insertion device and / or any parts thereof. Each component of the insertion device may have its own and / or individual distal position. For example, the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor may each have their own and / or individual distal positions, respectively. Prior to insertion, the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor may be in their distal position(s) and may be ready for inserting the medical device into the body tissue of the subject. After insertion, the cap and optionally the insertion tool retractor may be moved back to their distal positions, respectively, and the insertion tool may specifically be retracted from the body tissue when the insertion tool retractor may be back in its distal position and thus the insertion tool may also be moved to its distal position. The distal position of the insertion device and / or any parts after the insertion of the medical device, specifically of at least the insertable part of the medical device, such as the distal position after retraction of the insertion tool, may also be referred to as “distal retraction position”. The distal retraction position of one or more of the components of the insertion device may be the same as the distal position, for example as an initial distal position. For example, the initial distal position may be the same as the distal retraction position. In particular, as an example, the distal position of the cap prior to the insertion may be the same as after the insertion. However, alternatively, the distal retraction position of at least one of the components of the insertion device may differ from the initial distal position of the same component. Thus, as an example, the distal position if the insertion tool prior to the insertion may differ from the distal position of the insertion tool after its retraction.
[0055] The term “proximal position” 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 position specification indicating a position of the insertion device and / or any parts thereof in relation to the subject in which the cap, the insertion tool, the insertion sleeve and / or optionally the insertion tool retractor are closest to the proximal side of the insertion device. Specifically, for inserting at least the insertable part of the medical device, the insertion device may be brought into contact with the skin site of the subject. The proximal position may refer to a position being in close proximity to the skin site of the subject. Each component of the insertion device may have its own and / or individual proximal position. For example, the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor may each have their own and / or individual proximal positions, respectively. In case the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor are in their proximal position, at least the insertable part of the medical device may be inserted into the body tissue of the subject. During insertion of the medical device, the guide sleeve may be in contact with the skin site of the subject and, thus, may be, during insertion, in its proximal position.
[0056] The movement of the cap together with the insertion tool, the insertion sleeve and optionally the insertion tool retractor from its distal position to its proximal position may be initiable by an action of the user and / or subject. Specifically, the action of the user and / or subject may be or may comprise application of a force, also referred to as the actuation force, to the cap by the user such as by manually pressing and / or pushing the cap downward towards the proximal position, in particular towards the subject’s skin. In particular, the user and / or subject when pressing and / or pushing the cap may be required to apply at least the actuation force for overcoming the resistance force provided by the resistance pairing in response to the actuation force in order to move the cap together with at least the insertion tool and the insertion sleeve from its distal position to its proximal position. The insertion device may be a mechanical insertion device, which preferably may be operated by hand, preferably without the need of electrical or electromechanical actuators. However, other embodiments are feasible.
[0057] The insertion movement may be completed when the cap is in its proximal position. The cap when being in the proximal position may align with the proximal end of the guide sleeve. Thus, in its proximal position, a proximal end of the cap may contact the subject’s skin in a similar way as the guide sleeve may contact the subject’s skin.
[0058] The movement of the cap, optionally together with the insertion tool retractor, from its proximal position to its distal position may be initiable by relieving the action of the user and / or subject. Specifically, the user and / or subject may reduce or may stop applying the force, i.e. the actuation force, to the cap thereby initiating movement of the cap, optionally together with the insertion tool retractor, from its proximal position to its distal position. The term “relieving” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of completely stopping applying the action and to a process of partially stopping applying the action such as by reducing or diminishing the force onto the cap. The elastic member may be configured for driving the insertion tool retractor to move from its proximal position to its distal position, specifically to its distal retraction position. Specifically, the elastic member may be configured for retracting the insertion tool retractor after insertion of the at least one insertable part of the medical device. The term “elastic member” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element which, when being compressed or stretched from its resting position, may exert a force opposing to the compression or stretch. The elastic member may be configured for applying the force to one or more further elements of the insertion device. Specifically, the elastic member may be compressed or stretched when the at least one insertable part of the medical device is inserted into the body tissue or, alternatively, the elastic member may already be in a compressed or stretched state, such as in a pre-tensioned state, prior to use of the insertion device. The elastic member may be or may comprise at least one spring. The spring may be connected to the insertion tool retractor. The spring may be pre-tensioned, specifically in between the insertion sleeve and the insertion tool retractor. In particular, the elastic member, preferably the spring, is located in a distal receptacle of the insertion sleeve. Provided that the user and / or subject applies the actuation force to the cap, the spring may not be able to move the insertion tool retractor and the cap from their proximal position to their distal position, respectively. The spring may be actuable by the user and / or subject releasing the actuation force applied to the cap. Specifically, the spring may be configured to drive the movement of the insertion tool retractor and of the cap from their proximal positions to their distal positions, specifically to their distal retraction positions. However, the spring may only be able to move from its compressed position towards its resting position, thereby applying the spring force, after the cap and / or insertion tool retractor have reached their proximal positions, respectively, and when the force applied to the cap is reduced.
[0059] The latch arm may engage the resisting member in the distal position. For example in the distal position, in particular in the initial distal position, of the insertion device and / or its components, the latch arm and the resisting member may engage. Specifically, the latch arm may engage the resisting member, when one or more of the insertion sleeve, the cap and the guide sleeve are in their distal positions. Thus, in its initial distal position, the insertion sleeve may be positioned relative to the guide sleeve such that the latch arm engages the resisting member. Additionally or alternatively, in its initial position, the cap may be positioned relative to the guide sleeve such that the latch arm engages the resisting member.
[0060] The latch arm may extend from its fixed end towards its free end at an angle a with respect to the insertion axis. In particular, a direct line between the latch arm’s fixed end and the latch arm’s free end may be positioned at the angle a from the insertion axis. In particular, a may be in the range of from 0° to 30°, such as 0° < a < 30°. Specifically, a may be in the range of from 0° to 20°, such as 0° < a < 20°. More specifically, a may be in the range of from 7° to 20°, such as 7° < a < 20°. More specifically, a may be in the range of from 10° to 17°, such as 10° < a < 17°. More specifically, a may be approximately 15°, such as a = 15°±1°.
[0061] The latch arm at its free end may comprise at least one rounded surface. As an example, the rounded surface may have at least one radius r. In particular, r may be 0.5mm < r < 2mm. Specifically, r may be 0.6 < r < 1.8mm. More specifically, r may be 0.7mm < r < 1.5mm. More specifically, r may be 1mm.
[0062] The latch arm from its free end to its fixed end may have a length L parallel to the insertion axis. Specifically, though the direct line between the latch arm’s fixed end and the latch arm’s free end may be positioned at the angle a from the insertion axis, a distance between the fixed end and the free end in a direction parallel to the insertion axis may be referred to as “length L”. In particular, L may be 8mm < L < 20mm. Specifically, L may be 10mm < L < 15mm. More specifically, L may be approximately 12.75mm, such as L = 12.75±0.5mm.
[0063] The resisting member comprise at least one sloped surface. As an example, the sloped surface may be configured for guiding a movement direction of the latch arm, e.g. by providing a sliding surface along which the latch arm’s free end may be guided when the user and / or subject applies the actuation force onto the cap, thereby e.g. deforming the latch arm.
[0064] The sloped surface has an angle P with respect to the insertion axis. In particular, p may be 45° < p < 60°. Specifically, P may be 50° < p < 59°. More specifically, P may be approximately 57°, such as P = 57±1°. The angle of the sloped surface allows to precisely tune the amount of pressure needed for the latch arm to overcome the resisting member.
[0065] As an example, the sloped surface may have a length 1 in a direction perpendicular to the insertion axis. Specifically, a distance from one end of the sloped surface to the other end of the sloped surface, such as a distance between the two edges of the sloped surface, in a direction perpendicular to the insertion axis, may be referred to as “length 1”. In particular, 1 may be 0.1mm < 1 < 2mm. Specifically, 1 may be 1.1 < 1 < 1.8mm. More specifically, 1 may be 1.2mm < 1 < 1.6mm. More specifically, 1 may be approximately 1.4mm, such as 1 = 1.4±0.1mm. At least one of the insertion sleeve and the cap in conjunction with the guide sleeve may form more than one resistance pairing. Thus, as an example, the insertion sleeve and the guide sleeve, in conjunction, may form more than one resistance pairing. Additionally or alternatively, the cap and the guide sleeve, in conjunction, may form more than one resistance pairing. Further additionally or alternatively, the insertion sleeve and the guide sleeve, in conjunction, as well as the cap and the guide sleeve, in conjunction, may each form one or more resistance pairings. Specifically, at least one of the insertion sleeve and the cap in conjunction with the guide sleeve may form at least two resistance pairings. More specifically, at least one of the insertion sleeve and the cap in conjunction with the guide sleeve may form at least three resistance pairings. Thus, as an example, the insertion device may have at least two latch arms, specifically at least three latch arms, configured for engaging at least one resisting member, specifically at least two resisting members, more specifically at least three resisting members.
[0066] The at least two resistance pairings, specifically the at least three resistance pairings, may be equally arranged and spaced around the insertion axis. Thus, the at least two latch arms, specifically the at least three latch arms, may be equally arranged and spaced around the insertion axis.
[0067] As an example, two resistance pairings may be formed by two latch arms engaging at least one resisting member. In particular, the resisting member may be or may comprise one resisting member configured for engaging both latch arms. Alternatively, two individual resisting members may be present to engage the two latch arms, e.g. separately.
[0068] Similarly, three resistance pairings may be formed by three latch arms engaging at least one resisting member. In particular, the resisting member may be or may comprise one resisting member configured for engaging three latch arms. Alternatively, three individual resisting members may be present to engage the three latch arms, e.g. separately.
[0069] For example, the resisting member may be or may comprise one continuous resisting member surrounding the insertion axis. Thus, the resisting member may specifically be encircling the insertion axis. As an example, independent from the number of latch arms, the insertion device may comprise one continuous resisting member surrounding the insertion axis. Thus, as an example, the number of latch arms may equal the number of resistance pairings formed by one of the insertion sleeve and the cap in conjunction with the guide sleeve of the insertion device. The insertion sleeve may comprise the at least one resisting member and the guide sleeve may comprise the at least one latch arm. Thus, the at least one resisting member may be connected to an outer surface of the insertion sleeve and the at least one latch arm at its fixed end may be connected to an inner surface of the guide sleeve. Specifically, in this setup, the outer surface of the insertion sleeve may be a surface of the insertion sleeve facing the guide sleeve and the inner surface of the guide sleeve may be a surface of the guide sleeve facing the insertion sleeve.
[0070] The resisting member and the insertion sleeve may be formed in one piece, e.g. as a monolithic element. For example, the insertion sleeve and the resisting member may be one injection molded piece.
[0071] Specifically, the latch arm and the guide sleeve may be formed in one piece, e.g. as a monolithic element. For example the guide sleeve and the latch arm may be one injection molded piece.
[0072] As an example, in case the latch arm is comprised by the guide sleeve, its free end may be arranged closer to the guide sleeve’s distal end than its fixed end. Further, in the distal position, the insertion sleeve and the guide sleeve may be arranged such that the resisting member of the insertion sleeve is positioned at a greater distance from the guide sleeves distal end than the free end of the latch arm.
[0073] Alternatively, e.g. as another example, in case the latch arm is comprised by the insertion sleeve, its free end may be arranged closer to the insertion sleeve’s proximal end than its fixed end. Further, in the distal position, the insertion sleeve and the guide sleeve may be arranged such that the resisting member of the guide sleeve is positioned closer to the guide sleeves proximal end than the free end of the latch arm.
[0074] One or both of the latch arm and the resisting member may be or may comprise at least one material having a friction coefficient p below or equal to 0.5. In particular, p may be 0.04 < p < 0.12. Specifically, p may be 0.06 < p < 0.08.
[0075] In particular, the at least one latch arm may comprise at least one polycarbonate, such as Makrolon®, specifically Makrolon® M204 LF. Other sliding-modified materials may also be feasible.
[0076] Specifically, the at least one resisting member may comprise at least one polycarbonate, such as Makrolon®, specifically Makrolon® M204 LF. Other sliding modified materials may also be feasible. Specifically the latch arm and the resisting member may be or may comprise one or more sliding modified material pairing.
[0077] As outlined above, the elastic member may be configured for driving the insertion tool retractor to move from its proximal position to its distal position, specifically to its distal retraction position. As an example, the elastic member may comprise at least one spring, wherein the spring may be connected to the insertion tool retractor. In particular, the spring may be pre-tensioned and may be actuatable by releasing the actuation force applied to the cap. As an example, the at least one spring may be configured to drive the movement of the insertion tool retractor from its proximal position to its distal position, specifically to its distal retraction position, and thereby also driving the movement of the cap from its proximal position to its distal position. As outlined above, the cap, when being in its proximal position, may align with a proximal end of the guide sleeve.
[0078] As described above, the medical device may comprise at least one analyte sensor for detecting at least one analyte in a bodily fluid of the subject. Further, the medical device may comprise at least one sensor patch. As an example, the medical device may comprise the analyte sensor received in the sensor patch, e.g. as described in further detail below. Thus, the insertion device may be configured for receiving the sensor patch and for attaching the sensor patch to the skin site of the user. The insertion device may be configured for attaching and / or arranging the sensor patch to the skin site of the user, in particular simultaneously with the insertion of the insertion tool into the body tissue of the user. In particular, the insertion sleeve may comprise at least one receptacle for the sensor patch, e.g. located on the proximal end of the insertion sleeve, in which the sensor patch may be deposited before insertion.
[0079] In a further aspect of the present invention, an insertion system for inserting at least one insertable part of a medical device into a body tissue of a subject is disclosed. The insertion system comprises the insertion device as disclosed herein, specifically as described above or as further described below, and a medical device. For possible definitions and options of the insertion system, reference is made to the disclosure of the insertion device according to the present invention.
[0080] In particular, the medical device may comprise at least one analyte sensor for detecting at least one analyte in a bodily fluid of the subject. Specifically, the medical device may be or may comprise one or more of the medical devices as described herein, specifically as described above, e.g. with regard to the insertion device, or as further described below. The medical device may further comprise at least one sensor patch. In particular, the sensor patch may be held in a receptacle of the insertion sleeve, in particular in a proximally positioned receptacle of the insertion sleeve. Thus, during insertion, the sensor patch may be configured to move together with the insertion sleeve and to be released from the insertion sleeve when the insertion sleeve is in its proximal position. The term “sensor patch” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an element configured for being attached to the skin site of the subject. In particular, the sensor patch may have a flat base, which is configured for being attached to the skin site of the subject. The sensor patch may comprise an electronics unit, which may be configured for being connected to the medical device, specifically to the analyte sensor. The electronics unit may have large dimensions compared to the analyte sensor and to the insertion tool. The diameter of the insertion tool may be as large as 1 mm while the sensor patch may extend for up to 2 to 4 cm. The sensor patch may comprise at least one adhesive means for being attached to the skin site of the subject. The sensor patch may remain attached to the skin site of the subject after the insertable part of the medical device, e.g. of the analyte sensor, has been inserted into the body tissue of the subject. The insertion tool may protrude through the sensor patch received in the insertion device, specifically in the insertion sleeve of the insertion device.
[0081] In particular, if the medical device comprises a sensor patch, the insertion of the insertable part of the medical device into the body tissue of the subject may be facilitated and more reliable. When the insertion system is applied to the skin, the skin typically bulges toward the interior of the insertion device. The short time delay between the insertion device, in particular the insertion tool, being in the proximal position and the insertion device, in particular the insertion tool, being moved back in its distal position may allow the application of pressure onto the bulged skin by the sensor patch. This may compensate the inward bulging of the skin as well as the indenting of the inward bulged skin by the insertion tool. Thus, the sliding of the insertion tool together with the insertable part of the medical device into the skin may be facilitated.
[0082] 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 at least one insertion system as disclosed herein, specifically as described above or as further described below. Thus, for possible definitions and options, reference may be made to the disclosure of the insertion system and / or the insertion 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.
[0083] The method comprises the following steps: a) inserting the medical device into the body tissue of the subject by applying the actuation force on the cap of the insertion device thereby moving the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor relative to the guide sleeve from a distal position to a proximal position; and b) retracting the insertion tool by relieving the actuation force applied to the cap, thereby moving the cap from its proximal position to its distal position and the insertion tool, optionally via the insertion tool retractor, from its proximal position to its distal position, specifically to its distal retraction position.
[0084] The movement of the cap together with the insertion tool, the insertion sleeve and optionally the insertion tool retractor from its distal position to its proximal position may be initiated by action of the subject, specifically by applying a force, such as the actuation force, to the cap of the insertion device. The force, specifically the actuation force, may be applied by the user and / or subject of the insertion device before and during the insertion of the at least one insertable part of the medical device into the body tissue of the subject. The insertion of the at least one insertable part of the medical device may be started by setting the guide sleeve, in particular the proximal end of the guide sleeve, in contact with the skin of the subject, specifically at an insertion site. Thus, step a) of the method may comprise applying the insertion device to the skin site of the subject, in particular applying the guide sleeve of the insertion device to the skin site of the subject.
[0085] Prior to insertion, the insertion sleeve may be in its distal position and may be at least partially enclosed by the guide sleeve in its distal position. The cap may be in contact to the insertion sleeve, specifically at the distal end of the insertion sleeve. Prior to insertion, the insertion tool, and optionally the insertion tool retractor, may be in its starting position and may be at least partially enclosed by the insertion sleeve. The starting position of the insertion tool, and optionally of the insertion tool retractor, may be at a proximal position relative to the insertion sleeve. The elastic member may be in between the insertion tool retractor and the insertion sleeve and the elastic member may be at full tension. The insertion sleeve and / or the cap may be arranged relative to the guide sleeve, such that the at least one latch arm engages the resisting member.
[0086] When the user and / or subject exerts the force to the cap, the arm of the user and / or subject, for example one or more fingers or a palm of the hand, which applies the force to the cap, may accelerate in proximal direction, specifically towards the skin of the subject. In particular, such an acceleration may be guided and / or provoked by the force, e.g. the actuation force, such as the inserter release force, having to be higher than the resistance force with which the at least resistance pairing acts against the force exerted by the user and / or subject onto the cap. Specifically, the resistance force may be or may exert an initial force, specifically in the proximal position, which may be necessary to be overcome by the user and / or subject. After the resistance force is overcome, the force exerted by the user and / or subject, which is required to move the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor relative to the guide sleeve, may still be higher than the resistance force, thereby for example resulting in an acceleration of the movement. The movement may be stopped when the insertion device reaches its proximal position, e.g. when the proximal end of the cap and / or the insertion sleeve aligns with the proximal end of the guide sleeve. Because of the kinetic energy of the mass of the arm, this stopping may cause pressure of the insertion sleeve against the skin of the subject.
[0087] Step b) may comprise relieving the actuation force applied to the cap. In particular, the movement of the cap together with the insertion tool, the insertion sleeve and optionally the insertion tool retractor from its proximal position to its distal position, specifically to its distal retraction position, may be initiated by a relieving action of the subject, e.g. by the subject removing the actuation force from the cap. As an example, triggered by relieving the actuation force applied to the cap, the insertion tool may be moved back from the skin site of the subject. When the user releases the force, the elastic element, in particular the spring, may force the insertion tool, optionally via the insertion tool retractor, and in consequence the cap into movement towards the distal position.
[0088] The devices, systems and methods according to the present invention provide a large number of advantages over known methods and devices. Specifically, the devices, systems and methods according to the present invention may allow for a specified, low scattering and reproducible actuation force, specifically within predefined limits, in particular due to the resistance pairing formed by the insertion sleeve and the guide sleeve. Furthermore, the devices, systems and methods according to the present invention may allow for a safe insertion of the medical device, due to the at least one resistance pairing providing the resistance force allowing to prevent accidental and / or unintentional insertion. In addition, the devices, systems and methods according to the present invention may allow for a safe insertion of the medical device, due to the at least one resistance pairing providing the resistance force allowing to accelerate the movement of the user’s and / or subject’s hand when moving the insertion device from its distal position to it proximal position, thereby allowing for a successful insertion of at least the insertable part of the medical device, e.g. of the sensor, into the body tissue of the subject. Furthermore, the devices, systems and methods according to the present invention, specifically due to the construction of the resistance pairing, may prevent plastic deformation of the insertion device and / or its components during the insertion and may allow for a constant actuation force when the insertion device is used, specifically sequentially, for multiple insertions.
[0089] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:
[0090] Embodiment 1 : An insertion device for inserting at least one insertable part of a medical device into a body tissue of a subject along an insertion axis, the insertion device comprising: an insertion tool; optionally an insertion tool retractor; optionally an elastic member; a cap; an insertion sleeve and a guide sleeve configured for guiding the insertion sleeve therein, wherein the insertion sleeve and / or the cap in conjunction with the guide sleeve form at least one resistance pairing comprising at least one latch arm and at least one resisting member, wherein at least one of the insertion sleeve and the cap comprises one of the at least one latch arm and the at least one resisting member of the resistance pairing and wherein the guide sleeve comprises the at least one other of the at least one latch arm and the at least one resisting member of the resistance pairing; wherein, for inserting the at least one insertable part of the medical device, the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor are movable relative to the guide sleeve from a distal position to a proximal position, specifically to a proximal insertion position, wherein the cap is movable from its distal position to its proximal position by an actuation force parallel to the insertion axis, wherein the actuation force is greater than a resistance force provided by the resistance pairing in response to the actuation force.
[0091] Embodiment 2: The insertion device according to the preceding embodiment, wherein in the distal position, specifically in an initial distal position, the latch arm engages the resisting member.
[0092] Embodiment 3 : The insertion device according to any one of the preceding embodiments, wherein the latch arm extends from its fixed end towards its free end at an angle a with respect to the insertion axis, wherein 5° < a < 30°, specifically 0° < a < 20°, more specifically 7° < a < 20°, more specifically 10° < a < 17°, more specifically a = 15°±1°. Embodiment 4: The insertion device according to any one of the preceding embodiments, wherein the latch arm at its free end comprises at least one rounded surface.
[0093] Embodiment 5: The insertion device according to the preceding embodiment, wherein the rounded surface has at least one radius r, wherein 0.5 < r < 2mm, specifically 0.6 < r < 1.8mm, more specifically 0.7mm < r < 1.5mm, more specifically r may be 1mm.
[0094] Embodiment 6: The insertion device according to any one of the preceding embodiments, wherein the latch arm from its free end to its fixed end has a length L parallel to the insertion axis, wherein 8mm < L < 20mm, specifically 10mm < L < 15mm, more specifically L = 12.75±0.5mm.
[0095] Embodiment 7: The insertion device according to any one of the preceding embodiments, wherein the resisting member comprises at least one sloped surface.
[0096] Embodiment 8: The insertion device according to the preceding embodiment, wherein the sloped surface has an angle P with respect to the insertion axis, wherein 45° < p < 60°, specifically 50° < P < 59°, more specifically P = 57±1°.
[0097] Embodiment 9: The insertion device according to any one of the two preceding embodiments, wherein the sloped surface has a length 1 in a direction perpendicular to the insertion axis, wherein 1mm < 1 < 2mm, specifically 1.1 < 1 < 1.8mm, more specifically 1.2mm < 1 < 1.6mm, more specifically 1 = 1.4±0.1mm.
[0098] Embodiment 10: The insertion device according to any one of the preceding embodiments, wherein at least one of the insertion sleeve and the cap in conjunction with the guide sleeve form more than one resistance pairing, specifically at least two resistance pairings, more specifically at least three resistance pairings.
[0099] Embodiment 11 : The insertion device according to the preceding embodiment, wherein the at least two resistance pairings, specifically the at least three resistance pairings, are equally arranged and spaced around the insertion axis.
[0100] Embodiment 12: The insertion device according to any one of the preceding embodiments, wherein the resisting member is one continuous resisting member surrounding the insertion axis. Embodiment 13: The insertion device according to any one of the preceding embodiments, wherein the insertion sleeve comprises the at least one resisting member and wherein the guide sleeve comprises the at least one latch arm, such that the resisting member is connected to an outer surface of the insertion sleeve and the latch arm at its fixed end is connected to an inner surface of the guide sleeve, specifically wherein the outer surface of the insertion sleeve is a surface of the insertion sleeve facing the guide sleeve and wherein the inner surface of the guide sleeve is a surface of the guide sleeve facing the insertion sleeve.
[0101] Embodiment 14: The insertion device according to the preceding embodiment, wherein the resisting member and the insertion sleeve are formed in one piece, e.g. as a monolithic element, for example the insertion sleeve and the resisting member are one injection molded piece.
[0102] Embodiment 15 : The insertion device according to any one of the two preceding embodiments, wherein the latch arm and the guide sleeve are formed in one piece, e.g. as a monolithic element, for example the guide sleeve and the latch arm are one injection molded piece.
[0103] Embodiment 16: The insertion device according to any one of the preceding embodiments, wherein one or both of the latch arm and the resisting member comprises at least one material having a friction coefficient p of 0.04 < p < 0.12, specifically 0.06 < p < 0.08.
[0104] Embodiment 17: The insertion device according to any one of the preceding embodiments, wherein the at least one latch arm comprises at least one polycarbonate, such as Mak- rolon®, specifically Makrolon® M204 LF.
[0105] Embodiment 18: The insertion device according to any one of the preceding embodiments, wherein the at least one resisting member comprises at least one polycarbonate, such as Makrolon®, specifically Makrolon® M204 LF.
[0106] Embodiment 19: The insertion device according to any one of the preceding embodiments, wherein the elastic member is configured for driving the insertion tool retractor to move from its proximal position to its distal position, specifically to its distal retraction position. Embodiment 20: The insertion device according to the preceding embodiment, wherein the elastic member comprises at least one spring, wherein the spring is connected to the insertion tool retractor.
[0107] Embodiment 21 : The insertion device according to the preceding embodiment, wherein the spring is pretensioned and is actuatable by releasing the actuation force applied to the cap.
[0108] Embodiment 22: The insertion device according to any one of the two preceding embodiments, wherein the at least one spring is configured to drive the movement of the insertion tool retractor from its proximal position to its distal position, specifically to its distal retraction position, and thereby also driving the movement of the cap from its proximal position to its distal position.
[0109] Embodiment 23 : The insertion device according to any one of the preceding embodiments, wherein the cap, when being in its proximal position, aligns with a proximal end of the guide sleeve.
[0110] Embodiment 24: The insertion device according to any one of the preceding embodiments, wherein the medical device comprises at least one analyte sensor for detecting at least one analyte in a bodily fluid of the subject.
[0111] Embodiment 25 : An insertion system for inserting at least one insertable part of a medical device into a body tissue of a subject comprising the insertion device according to any one of the preceding embodiments and the medical device.
[0112] Embodiment 26: The insertion system according to the preceding embodiment, wherein the medical device comprises at least one analyte sensor for detecting at least one analyte in a bodily fluid of the subject.
[0113] Embodiment 27 : The insertion system according to any one of the two preceding embodiments, wherein the medical device comprises a sensor patch.
[0114] Embodiment 28: The insertion system according to the preceding embodiment, wherein the sensor patch comprises a flat base, which is configured for being attached to a skin site of the subject. Embodiment 29: A method of inserting at least one insertable part of a medical device into a body tissue of a subject by using at least one insertion system according to any one of the preceding embodiments referring to an insertion system, wherein the method comprises: a) inserting the medical device into the body tissue of the subject by applying the actuation force on the cap of the insertion device thereby moving the cap, the insertion tool, the insertion sleeve and optionally the insertion tool retractor relative to the guide sleeve from a distal position to a proximal position; and b) retracting the insertion tool by relieving the actuation force applied to the cap, thereby moving the cap from its proximal position to its distal position and the insertion tool, optionally via the insertion tool retractor, from its proximal position to its distal position, specifically to its distal retraction position.
[0115] Embodiment 30: The method according to the preceding embodiment, wherein the movement of the cap together with the insertion tool, the insertion sleeve and optionally the insertion tool retractor from its distal position to its proximal position is initiated by an action of the subject, e.g. by the subject applying the actuation force on the cap.
[0116] Embodiment 31 : The method according to the preceding embodiment, wherein the movement of the cap together with the insertion tool, t the insertion sleeve and optionally the insertion tool retractor from its proximal position to its distal position, specifically to its distal retraction position, is initiated by a relieving action of the subject, e.g. by the subject removing the actuation force from the cap.
[0117] Short description of the Figures
[0118] 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.
[0119] In the Figures:
[0120] Figure 1 shows an embodiment of an insertion device in a sectional view;
[0121] Figure 2 shows an enlarged part of the insertion device of Figure 1; and Figure 3 shows a method of inserting at least one insertable part of a medical device into a body tissue of a subj ect by using at least one embodiment of an insertion system comprising an embodiment of an insertion device.
[0122] Detailed description of the embodiments
[0123] Figures 1 and 2 illustrate an embodiment of an insertion device 110 in sectional views, while Figure 3 illustrates a method of inserting at least one insertable part of a medical device 112 into a body tissue 114 of a subject by using at least one embodiment of an insertion system 111 comprising an embodiment of the insertion device 110. The insertion system 111 comprises the insertion device 110 and the medical device 112. The figures are described together.
[0124] The insertion device 110 is configured for inserting the at least one insertable part of the medical device 112 into the body tissue 114 of the subject along an insertion axis 116. The insertion device 110 comprises an insertion tool 117. Optionally the insertion device 110 comprises one or more of an insertion tool retractor 118 and an elastic member, for example a spring 120. The insertion device 110 further comprises a cap 122, an insertion sleeve 124 and a guide sleeve 126 configured for guiding the insertion sleeve 124 therein. The insertion sleeve 124 or the cap 122 in conjunction with the guide sleeve 126 form at least one resistance pairing 128 comprising at least one latch arm 130 and at least one resisting member 132. In particular, the resistance pairing 128 may be formed, in conjunction, by the insertion sleeve 124 and the guide sleeve 126. As an example, the insertion sleeve 124 and the guide sleeve, in conjunction, may form more than one resistance pairing 128, specifically at least two resistance pairings 128, as exemplarily illustrated in Figure 1.
[0125] The insertion sleeve 124 may comprise one of the at least one latch arm 130 and the at least one resisting member 132 of the resistance pairing 128 and the guide sleeve 126 may comprise the at least one other of the at least one latch arm 130 and the at least one resisting member 132 of the resistance pairing 128.
[0126] In the illustrated examples, the resisting member 132 is comprised by the insertion sleeve 124 and the at least one latch arm 130 is comprised by the guide sleeve 126. However, an embodiment in which the resisting member 132 is comprised by the guide sleeve 126 and the latch arm 130 is comprised by the insertion sleeve 124 is also feasible. Additionally or alternatively, an embodiment in which the cap 122 comprises one of the at least one latch arm 130 and the at least one resisting member 132 of the resistance pairing 128 and the guide sleeve 126 comprises the at least one other of the at least one latch arm 130 and the at least one resisting member 132 of the resistance pairing 128 is also feasible.
[0127] For inserting the at least one insertable part of the medical device 112, the cap 122, the insertion tool, the insertion tool retractor 118 and the insertion sleeve 124 are movable relative to the guide sleeve 126 from a distal position 134 to a proximal position 136. Exemplarily, the setups on the left and on the right of Figure 3 illustrate the insertion system 110 comprising the insertion device 110 in its distal position 134, wherein the setup of the insertion system 111 in the middle of Figure 3 exemplarily illustrates the insertion device 110 in its proximal position 136.
[0128] The cap 122 is movable from its distal position 134 to its proximal position 136 by an actuation force, exemplarily illustrated by arrow 138, parallel to the insertion axis 116. The actuation force is greater than a resistance force, exemplarily illustrated by arrow 140, provided by the resistance pairing 128 in response to the actuation force.
[0129] In the distal position 134, the at least one latch arm 130 may engage the resisting member 132. Such an engagement is exemplarily illustrated in detail in Figure 2. As an example, the latch arm 130 may extend from its fixed end 142 towards its free end 144 at an angle a 146 with respect to the insertion axis 116, wherein a 146 may for example be 15°. The latch arm 130 may at its free end 144 comprise at least one rounded surface having a radius r 148, wherein r 148 may for example be in the range of from 1.5mm to 2.5mm. Further, the latch arm 130 from its free end 144 to its fixed end 142 may have a length L 150 parallel to the insertion axis 116, wherein L 150 may for example be 12.75mm.
[0130] The resisting member 132 may, as an example, comprise at least one sloped surface 152. The sloped surface 152 may have an angle P 154 with respect to the insertion axis 116, wherein P may for example be 57°. The sloped surface 152 may further have a length 1 156 in a direction perpendicular to the insertion axis 116, wherein 1 156 may for example be 1.4mm. As an example, the resisting member 132 may be or may comprise one continuous resisting member 132 surrounding the insertion axis 116.
[0131] When the latch arm 130 engages the resisting member 132, the resistance force may be provided as a reaction force to the force applied by the user onto the cap 122. As soon as the applied force reaches the actuation force, which is higher than the resistance force, the latch arm 130 may elastically deform such that it may slide off of the resisting member 132, thereby allowing the insertion sleeve 124 to be pushed further in the direction towards its proximal position relative to the guide sleeve 126. As an example, when the user and / or subject applies the actuation force, the latch arm 130 at its free end 144 may slide off the resisting member 132 along the sloped surface 144 and then on an outside of the resisting member 132. This act of elastic deformation of the latch arm 130 may also be referred to as disengaging of the latch arm 130 from the resisting member 132, thereby overcoming the resistance force. Thus, resistance force may be overcome by applying a force greater than the resistance force, e.g. by applying the actuation force, specifically in a direction parallel to the insertion axis 116. In particular, the latch arm may disengage from the resisting member by performing the deformation, such as by transitioning into a deflected state (not shown).
[0132] The medical device 112 may comprise at least one analyte sensor 158 for detecting at least one analyte in a bodily fluid of the subject and at least one sensor patch 160 comprising a flat base 162 configured for being attached to a skin site 164 of the subject.
[0133] The transition from the setup on the left to the setup in the middle of Figure 3 and the transition of the setup of the middle to the setup on the right of Figure 3 exemplarily illustrates the method. The method of inserting the at least one insertable part of the medical device 112 into the body tissue 114 of the subject by using the at least one insertion system 111 comprises the following steps: a) (denoted by reference number 166) inserting the medical device 112 into the body tissue 114 of the subject by applying the actuation force on the cap 122 of the insertion device 110 thereby moving the cap 122, the insertion tool 117, the insertion sleeve 124 and optionally the insertion tool retractor 118 relative to the guide sleeve 126 from a distal position 134 to a proximal position 136; and b) (denoted by reference number 166) retracting the insertion tool 117 by relieving the actuation force applied to the cap 122, thereby moving the cap 122 from its proximal position 136 to its distal position 134 and the insertion tool 118, optionally via the insertion tool retractor 118, from its proximal position 136 to its distal position 134, specifically to its distal retraction position.
[0134] In particular, in the setup on the right of Figure 3, the insertion tool 117 may be in its distal position 134, specifically in its distal retraction position. List of reference numbers insertion device insertion system medical device body tissue insertion axis insertion tool insertion tool retractor spring cap insertion sleeve guide sleeve resistance pairing latch arm resisting member distal position proximal position arrow arrow fixed end free end angle a radius r length L sloped surface angle P length 1 analyte sensor sensor patch flat base subject’s skin site step a) step b)
Claims
Claims1. An insertion device (110) for inserting at least one insertable part of a medical device (112) into a body tissue (114) of a subject along an insertion axis (116), the insertion device (110)comprising: an insertion tool (117); a cap (122); an insertion sleeve (124) and a guide sleeve (126) configured for guiding the insertion sleeve (124) therein, wherein the insertion sleeve (124) and / or the cap (124) in conjunction with the guide sleeve (126) form at least one resistance pairing (128) comprising at least one latch arm (130) and at least one resisting member (132), wherein at least one of the insertion sleeve (124) and the cap (122) comprises one of the at least one latch arm (130) and the at least one resisting member (132) of the resistance pairing (128) and wherein the guide sleeve (126) comprises the at least one other of the at least one latch arm (130) and the at least one resisting member (132) of the resistance pairing (128); wherein, for inserting the at least one insertable part of the medical device (112), the cap (122), the insertion tool (117) and the insertion sleeve (124) are movable relative to the guide sleeve (126) from a distal position (134) to a proximal position (136), wherein the cap (122) is movable from its distal position (134) to its proximal position (136) by an actuation force parallel to the insertion axis (116), wherein the actuation force is greater than a resistance force provided by the resistance pairing (128) in response to the actuation force, and wherein the resisting member (132) comprises at least one sloped surface (152), wherein the sloped surface (152) has an angle P (154) with respect to the insertion axis (H6).
2. The insertion device (110) according to the preceding claim, wherein the insertion device further comprises one or more of an insertion tool retractor (118) and an elastic member (120).
3. The insertion device (110) according to any one of the preceding claims, wherein in the distal position (134) the latch arm (130) engages the resisting member (132).
4. The insertion device (110) according to any one of the preceding claims, wherein the latch arm (130) extends from its fixed end (142) towards its free end (144) at an anglea (146) with respect to the insertion axis (116), wherein the latch arm (130) at its free end (144) comprises at least one rounded surface.
5. The insertion device (110) according to any one of the preceding claims, wherein at least one of the insertion sleeve (124) and the cap (122) in conjunction with the guide sleeve (126) form at least two resistance pairings (128), wherein the at least two resistance pairings (128) are equally arranged and spaced around the insertion axis (116) 06. The insertion device (110) according to any one of the preceding claims, wherein the resisting member (132) is one continuous resisting member surrounding the insertion axis (116).
7. The insertion device (110) according to any one of the preceding claims, wherein the insertion sleeve (124) comprises the at least one resisting member (132) and wherein the guide sleeve (126) comprises the at least one latch arm (130), such that the resisting member (132) is connected to an outer surface of the insertion sleeve (124) and the latch arm (130) at its fixed end (142) is connected to an inner surface of the guide sleeve (126).
8. The insertion device (110) according to the preceding claim, wherein the resisting member (132) and the insertion sleeve (124) are formed in one piece.
9. The insertion device (110) according to any one of the two preceding claims, wherein the latch arm (130) and the guide sleeve (126) are formed in one piece.
10. The insertion device (110) according to any one of the preceding claims, wherein one or both of the latch arm (130) and the resisting member (132) comprises at least one material having a friction coefficient p of 0.04 < p < 0.1.
11. The insertion device (110) according to any one of the preceding claims, wherein the at least one latch arm (130) and / or the at least one resisting member (132) comprises at least one polycarbonate.
12. An insertion system (111) for inserting at least one insertable part of a medical device (112) into a body tissue (114) of a subject comprising the insertion device (110) according to any one of the preceding claims and the medical device (112).
13. The insertion system (111) according to the preceding claim, wherein the medical device (112) comprises at least one analyte sensor (158) for detecting at least one analyte in a bodily fluid of the subject.
14. A method of inserting at least one insertable part of a medical device (112) into a body tissue (114) of a subject by using at least one insertion system (111) according to any one of the preceding claims referring to an insertion system (111), wherein the method comprises: a) inserting the medical device (112) into the body tissue (114) of the subject by applying the actuation force on the cap (122) of the insertion device (110) thereby moving the cap (122), the insertion tool (117) and the insertion sleeve (124) relative to the guide sleeve (126) from a distal position (134) to a proximal position (136); and b) retracting the insertion tool (117) by relieving the actuation force applied to the cap (122), thereby moving the cap (122) from its proximal position (136) to its distal position (134) and the insertion tool from its proximal position (136) to its distal position (134).