HK1235651A1 - Medical device and method for producing a medical device - Google Patents

Description

Medical device and method for producing a medical device

Technical Field

A medical device, an insertion kit and a method for manufacturing a medical device are disclosed. The method and device according to the invention can be used, for example, for detecting at least one analyte in one or both of body tissues or body fluids. The invention is preferably applicable in the field of diabetes care in home monitoring and in hospital applications. In addition or alternatively, other uses are possible.

Background

A large number of devices and methods for producing devices for detecting at least one analyte in one or both of body tissues or fluids are known in the art. Generally, such devices comprise a portion which is implantable completely or at least partially in the body tissue and which is adapted to detect and/or monitor body functions, preferably one or more analytes. Without limiting the scope of the invention, in the following, reference is mainly made to the determination of glucose as an exemplary analyte.

In principle, the detection of at least one analyte in one or both of the body tissue or the body fluid may be performed discontinuously, wherein the analyte is detected within a sample of the body fluid of the user and/or continuously, transcutaneously via continuous monitoring, preferably continuous monitoring of the analyte in the interstitium. Both methods may use, for example, electrochemical sensors. In general, an electrochemical sensor may comprise electronic means adapted to generate an analyte-dependent electrical signal, which is detected and displayed, for example, by one or more user interfaces.

In vivo measurements, devices comprising electrochemical sensors implantable in body tissue are used. The active sensing part (e.g. sensing part) of the electrochemical sensor, which comprises the electrodes of the electrochemical sensor, is implanted subcutaneously and converts the analyte into a signal, in particular a ground current, e.g. by using an enzyme, such as glucose oxidase. However, the electronics of the device (e.g. the evaluation unit and/or the control unit) may be located outside the body of the user. The detection (especially amplification) of the current signal is a major challenge, since the amplification electronics of electrochemical sensors generally known in the art are highly sensitive to leakage currents, and thus the measurement results are affected even by very small leakage currents. In order to prevent leakage currents, the connection between the electrochemical sensor and the electronics of the device (in particular via the connector) must be designed to be liquid-tight. Furthermore, the use of connectors results in occupying an undesirably large space. Thus, current devices are designed to use the connector infrequently, thus mounting the electrochemical sensor directly to the circuit board (on which the electronics are located).

For example, in WO 2010/091028 a1, a method and device for monitoring an analyte in a bodily fluid is described. In one embodiment, the data processing unit may be coupled to the sensor such that the two devices are located in or on the body of the user and at least a portion of the analyte sensor is positioned transcutaneously. The data processing unit may comprise a portion of the sensor encapsulated within or on a printed circuit board of the data processing unit with, for example, potting or other protective material. Furthermore, WO 2011/025549 a1 discloses a method and a device for monitoring an analyte in a body fluid. Embodiments include in vivo analyte sensors and on-body electronics that collectively provide a body wearable sensor electronics, wherein the in vivo analyte sensor is fully integrated with the on-body electronics. Furthermore, in WO 2010/091005 a1, a device for inserting a medical device into the skin of a subject is described.

However, the device (in particular the electrochemical sensor) is designed for implantation into the body of a user. Therefore, sterilization of these devices is often required. A number of sterilization methods for sterilizing the devices are known in the art. Known sterilization methods are radiation sterilization (in particular with electron radiation and/or gamma radiation) methods and chemical sterilization methods (for example gas sterilization, in particular with ethylene oxide (EtO) sterilization).

US 8,252,229B 2 discloses an assembly of an analyte sensor with an analyte sensor insertion device, comprising packaging the assembled analyte sensor and sensor insertion device in a substantially airtight seal and irradiating the packaged assembled sensor and sensor insertion device with a predetermined dose using one or more electron beam accelerators.

In EP 1972267 a1, an in vivo system is described for measuring an analyte concentration in a human or animal body with at least one implantable sensor. In one embodiment, the sensor is disposed inside the first housing chamber, which is then sealed. Furthermore, the housing chamber is irradiated by an intensive radiation (e.g. electron radiation) in order to sterilize the sensor and the insertion needle.

US 2008/0234561 a1 discloses a measurement system comprising replaceable sensors for in vivo placement. In one embodiment, the sensor is disposed in the first housing chamber and the chamber is then sealed. Subsequently, the sensor in the housing chamber will be sterilized by irradiation. It is also described that particularly suitable are electron rays having a dose of at least 20 kGy. In particular, an electron beam dose of 28 kGy is particularly suitable.

However, sterilization of the device (particularly the assembly of the electrochemical sensor and the electronics) by means of radiation will lead to damage of the electronics. On the other hand, sterilization methods commonly used to sterilize electronic devices (e.g., sterilization with EtO) will result in damage to the electrochemical sensor, particularly damage to the enzymes of the electrochemical sensor. Therefore, sterilization methods that allow sterilization of both electrochemical sensors and electronics without damage are desirable. Several attempts have been made in the art to overcome this problem.

In US 2008/0255440 a1, a sensor package is described comprising an implantable sensor having an electrode area and an electrical contact area. The electrode area is enclosed in a shielding package impermeable to microorganisms such that the electrical contact area extends outside the shielding package and the portion of the sensor located outside the shielding package is sterilized. The sensor may be sterilized by means of radiation, while the electronics may be sterilized solely by means of some other and low-cost sterilization process. In JP 2003072861 a or US 2003/0050547 a1, similar devices with electrical contacts outside the package or shielding package are also described.

EP 2599505 a1 discloses a method of sterilizing an implantable sensor for detecting at least one analyte in body tissue. The implantable sensor is introduced inside a package that seals the sensor from bacteria and contains a protective screen against radiation. The protective screen protects the electronics from the sterilizing radiation and is arranged so as to sterilize the sensor by the sterilizing radiation.

Despite these improvements, there is a strong need for methods and apparatus that allow for simultaneous sterilization of electrochemical sensors and electronics using different suitable sterilization methods. Therefore, the electronics for reading out the sensor signals of the implantable sensors usually comprise sensitive microelectronic devices (e.g. semiconductor chips) which are often subject to severe damage when exposed to energy radiation (e.g. electron beams). In contrast, electrochemical sensors having test chemicals and/or electrodes capable of sensing the presence and/or concentration of an analyte are typically damaged by chemical sterilization (e.g., sterilization by EtO). Thus, sensor electronics and electrochemical sensors may typically have to be sterilized independently by suitable sterilization means. However, after sterilizing these components separately, assembly would have to be performed in a sterile environment. However, the assembly steps performed in a sterile environment are generally limited with respect to their complexity and nature. Thus, as far as possible, the brazing or bonding steps should not generally be performed in a clean room or sterile environment, due to harmful fumes or particles generated during these process steps. Furthermore, performing the process steps in a sterile environment often significantly increases the cost of these process steps.

Problems to be solved

It is therefore an object of the present invention to provide methods and devices for detecting at least one analyte in one or both of a body tissue or a body fluid, which overcome the above-mentioned disadvantages and challenges of the known methods and devices. In particular, methods and devices are disclosed that can provide a medical device having a sterilized portion implanted within and/or in contact with a user's body.

Disclosure of Invention

This problem is solved by a medical device, an insertion kit and a method for producing a medical device having the features of the independent claims. Preferred embodiments which may be realized in isolation or in any combination are set forth in the dependent claims.

The terms "having," "including," or any grammatical variations thereof, are used hereinafter in a non-exclusive manner. Thus, these terms may refer to the case where no other feature is present in the entity described in the context, other than the one introduced by these terms, as well as the case where one or more additional features are present. As an example, the words "a has B", "a comprises (comprises) B" and "a comprises (includes) B" may refer to the case where no other element is present in a other than B (i.e., the case where a consists only and exclusively of B), and the case where one or more additional elements are present in entity a other than B (e.g., elements C, C and D, or even additional elements).

Furthermore, the terms "preferably," "more preferably," "particularly," "more particularly," "specifically," "more specifically," or similar terms used hereinafter are used in connection with optional features and do not limit the possibilities of substitution. Thus, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As those skilled in the art will appreciate, the invention may be practiced by using alternate features. Similarly, features introduced by "in embodiments of the invention" or similar expressions are intended to be optional features, not to limit in any way the alternative embodiments of the invention, not to limit in any way the scope of the invention, and not to limit in any way the possibility of combining features introduced in this way with other optional or non-optional features of the invention.

In a first aspect of the invention, a medical device is disclosed, the medical device comprising at least one implantable device having at least one implantable portion adapted to be at least partially implanted into a body tissue of a user. The implantable device also has at least one contact portion connected to the implantable portion. Furthermore, the medical device comprises at least one housing. The housing is configured to receive the implantable portion. The housing is configured to provide a sterile package to seal the implantable portion from the surrounding environment. The housing includes at least one first portion and at least one second portion. The first portion and the second portion are removably connected to form a sterile package. The first portion includes at least one first sealing surface and the second portion includes at least one second sealing surface. The first sealing surface interacts with the second sealing surface to form a sealing region. The implantable device has an interconnect connecting the implantable portion with the contact portion. The interconnects are guided through the sealing area.

As used herein, the term "medical device" generally refers to any device configured to one or more of detect, determine, and monitor an analyte and/or a concentration of an analyte in a body tissue of a user. The medical device may be used in the field of home care and professional care, for example in hospitals.

As further used herein, the term "analyte" may refer to any element, component, or compound that may be present in a bodily fluid, and the concentration of that any element, component, or compound may be of interest to a user. Preferably, the analyte may be or may include any chemical substance or compound that may participate in the metabolism of the user, such as at least one metabolite. As an example, the at least one analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, lactate. However, other types of analytes may also or alternatively be used, and/or any combination of analytes may be determined. In general, any type of bodily fluid may be used. Preferably, the body fluid is a body fluid present in a body tissue of the user, e.g. in a interstitial tissue. Thus, by way of example, the body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of bodily fluids may also be used. Body fluids may typically be contained in body tissues.

The term "implantable device" generally refers to any element that includes at least one implantable portion. As will be outlined in more detail below, the implantable device may comprise at least one of the following: an implantable sensor, a cannula, a tube for detecting at least one analyte in a body tissue. As further used herein, the term "implantable portion" generally refers to any element suitable for at least partial implantation into the body tissue of a user. As further used herein, the term "at least partially implantable into a user's body tissue" means that the implantable portion is adapted to have an appropriate size for insertion into the user's body tissue (e.g., into subcutaneous tissue), and further, that the implantable portion is biocompatible so as to remain in the body tissue for an extended period of time, such as days or even weeks or months. Thus, as an example, the implantable portion, or at least the implantable component of the implantable portion, may have a biocompatible coating, such as at least one semi-permeable membrane that prevents migration of the sensor material into the body tissue, and that is still permeable to the at least one analyte. Furthermore, the implantable portion may have an elongated shape, as will be outlined in more detail below, for example an elongated shape having a length of 5 mm to 50 mm. Other dimensions are possible. As an example, the implantable portion may have less than 3 cm²E.g. less than 2 cm²Or even less than 1 cm²Total volume of (c).

The term "implanted" means that the implantable portion can be inserted into body tissue, either fully or partially. Thus, in the following, the terms "implanted" and "inserted" will be used as synonyms. Typically, the implantable portion may penetrate the skin of the user, in whole or in part, during implantation and/or during use of the implantable portion. Thus, the implantable portion may preferably be embodied as a transcutaneous implantable portion.

As generally used in the present invention, the term "user" may refer to a human or an animal, regardless of whether the human or animal, respectively, may be in a healthy state or may have one or more diseases. As an example, the user may be a human or animal suffering from diabetes. However, the invention may also or alternatively be applicable to other types of users.

As used herein, the term "contact connected to an implantable portion" refers to an element adapted to interact with other elements of a medical device, particularly adapted to connect an implantable device to other elements of a medical device. The contact portion is connected to the implantable portion connector. The connection may be a permanent connection or a removable and/or reversible connection. In one embodiment, the implantable portion and the contact portion may be designed as one element. As will be described in detail below, the contact portion may include one or more electrical contacts of the implantable portion.

In general, the housing provides any element of the implantable portion that protects it from the environment, in particular one or more of the following: mechanical influence from the outside; chemical influences, such as protection against moisture and/or gases; from the effects of microorganisms (e.g., germs, bacteria, viruses). The housing may provide a full enclosure from the surrounding environment. The housing may be at least partially made of a rigid material. In particular, the housing can be designed as a rigid housing, i.e. a housing which is not significantly deformed by the forces which usually occur during use of the implantable portion. Rigid materials are understood to be materials which do not deform significantly and/or macroscopically by the forces which occur in general under normal loads, for example loads of less than 1, 2, 3 or 5N. However, embodiments are possible in which the housing can be made at least partially as a deformable housing, i.e. a housing that can be deformed at least partially by the forces that typically occur during use of the implantable portion, without losing its protective effect.

The housing is configured to receive the implantable portion. Generally, the term "configured to receive" as used herein refers to a housing configured to enclose an implantable portion. In particular, the implantable portion may be inserted into the housing and/or may be permanently and/or reversibly mounted inside the housing.

By "sterile packaging" is understood packaging which seals the implantable portion from the surrounding environment, for example, which prevents the ingress of microorganisms. As used herein, the term "ambient environment" refers to any environmental influence, in particular a chemical influence, such as moisture and/or gas; from one or both of the effects of a microorganism (e.g., a pathogen, a bacterium, a virus). As further used herein, the term "sealed" refers to insulation from the surrounding environment, particularly in a microbe-tight manner. In a preferred embodiment, the housing may be at least partially made of a gas impermeable material, preferably an EtO impermeable material.

As used herein, the term "at least one first portion and at least one second portion of the housing" generally refers to two arbitrary portions of the housing. The housing may be configured as a two-part housing. For example, the housing may comprise two identical and/or different large halves. However, embodiments are possible in which the housing may comprise three or more parts. The first portion is removably connected with the second portion to form an aseptic package. As used herein, the term "removably connected" refers to a non-permanent connection of a first portion to a second portion. The first portion and the second portion may be connected using one or both of a form-fit connection, a press-fit connection. In a preferred embodiment, the first and second portions may be connected by a snap-fit connection.

The first portion includes at least one first sealing surface and the second portion includes at least one second sealing surface. As used herein, the term "sealing surface" of a first portion and a second portion generally refers to any portion of the first and second portions that is suitable for connection and configured to seal the first and second portions in a connected state. In general, the sealing surface may be arbitrarily shaped. For example, the sealing surfaces may be designed such that the first and second sealing surfaces cooperate with one another such that one of the first and second sealing surfaces may be configured to slide, move, or insert one or more of the other of the first and second sealing surfaces. In one embodiment, the first and second sealing surfaces may be annular sealing surfaces. In one embodiment, one or both of the first and second portions includes at least one sealing lip.

As described above, the first sealing surface interacts with the second sealing surface to form a sealing region. As used herein, the term "sealing area" refers to the area formed by the first and second sealing surfaces in the connected state of the first and second parts of the housing. As used herein, the term "interact to form a sealing region" refers to one of the first and second sealing surfaces being connected to the other of the first and second sealing surfaces, e.g., by pressing, resting, or the like.

In one embodiment, one or both of the first and second portions may be at least partially made of a deformable material, preferably an elastic material, in the sealing area. The deformable material may be selected from the group consisting of elastic materials, thermoplastic materials (e.g. polypropylene), thermoplastic elastomers.

As described above, the implantable device has an interconnection connecting the implantable portion with the contact portion. The interconnect is understood to mean any element suitable for connecting the implantable portion with the contact portion. In one embodiment, the interconnection portion may be designed in one piece, in particular in one piece, with the implantable portion and the contact portion. For example, an interconnect may be disposed between the implantable portion and the contact portion.

As used herein, the term "leading through the sealing area" means that the interconnection protrudes through the sealing area. In a preferred embodiment, the interconnect may be clamped between the first sealing surface and the second sealing surface. The interconnect may be pressed onto one of the first or second sealing surfaces by the other of the first and second sealing surfaces.

The implantable device may include at least one of: an implantable sensor, a cannula, a tube for detecting at least one analyte in a body tissue. For example, the cannula may be a needle having a central lumen for receiving the implantable sensor during insertion. Preferably, the cannula is a slotted cannula. As further used herein, the term "implantable sensor" refers to any element suitable for quantitative and/or qualitative detection of at least one analyte in a body tissue. The implantable sensor preferably comprises at least one sensor material, wherein the sensor material is adapted to perform at least one detectable reaction in the presence of the analyte. The sensor material may preferably be a sensor material selected from the group consisting of: an optical sensor material, wherein the optical sensor material is adapted to perform at least one optically detectable detection reaction in the presence of an analyte; an electrochemical sensor material, wherein the electrochemical sensor material is adapted to perform at least one electrically detectable detection reaction, such as an electrically detectable redox reaction, in the presence of an analyte.

The implantable sensor may preferably comprise at least one flexible substrate, for example a flexible substrate having an elongated shape, wherein the flexible substrate is extendable into the body tissue of the user. As an example, the flexible substrate may be made in whole or in part of one or more of a paper material, a cardboard material, a plastic material, a metallic material, a ceramic material, or any combination thereof, such as a laminate of two or more of the materials. As an example, the flexible substrate may comprise one or more plastic foils. The flexible substrate may have a thickness of less than 3 mm, for example less than 1 mm, for example as measured in a plane perpendicular to the extension of the flexible substrate. In particular, where the implantable sensor is an electrochemical sensor, the implantable sensor may have two or more electrodes applied to the substrate, such as at least one working electrode and at least one further electrode, such as at least one counter electrode and/or at least one reference electrode. For a potential example of an implantable sensor, reference may be made to the prior art documents listed above. Other types of implantable sensors may also or alternatively be used.

In embodiments, the housing may be at least partially cylindrical, for example cylindrical with a circular cross-section, or cylindrical with a polygonal cross-section. The term "at least partially cylindrical" is understood to mean that the housing has a generally cylindrical shape. However, the housing parts can be designed to be non-cylindrical. In this embodiment, the housing may have a longitudinal axis, wherein the implantable portion received inside the sterile package extends at least partially parallel to, preferably along, the longitudinal axis. The term "extends at least partially parallel" is to be understood that deviations from parallel extension are possible. As an example, the implantable portion may extend at an angle of less than 25 ° from the longitudinal axis, for example at an angle of less than 10 ° or at an angle of less than 5 °. The contact portion may be at least partially curved away from the longitudinal axis. For example, the contact portion may be at least partially bendable away from the longitudinal axis, thereby allowing the contact portion to connect with other elements of the medical device. Additionally or alternatively, other embodiments are possible in which the housing is non-cylindrical.

The contact portion may be adapted to provide at least one of a mechanical contact or an electrical contact to at least one further device interacting with the implantable device.

The contact portion may include at least one electrical contact. Thus, as an example, the electrical contact may comprise at least one electrical contact pad provided on at least one carrier, e.g. on at least one substrate (e.g. a flexible substrate). As an example, at least one contact pad may have a rectangular or polygonal shape and may include one or more metal layers suitable for electrical connection by bonding, soldering, or other electrical contact methods, as examples. The implantable device can be electrically connected to the contact portion via the electrical contact. The further device may comprise at least one electronic device, wherein the electronic device may be connected to the electrical contacts outside the sterile packaging. As an example and as will be outlined in more detail below, the at least one electronic device may comprise at least one device for driving the implantable device and/or for reading out one or more signals generated or provided by the implantable device.

The implantable device may comprise at least one electrochemical sensor for electrochemical detection of at least one analyte in one or both of the body tissue or the body fluid, wherein the at least one electronic device may comprise at least one electronic device for measuring and/or recording a sensor signal generated by the electrochemical sensor. As used herein, the term "sensor signal" refers to any signal generated by an electrochemical sensor that indicates the presence of an analyte. The sensor signal may be generated at a later point in time, for example over a period of hours, days, weeks or even months, for example over a period of seven days. The sensor signals can be processed or preprocessed within the control device, for example by applying at least one evaluation or pre-evaluation algorithm to the sensor signals. Thus, the electronic device may comprise one or more of at least one data recording device, at least one data storage device, at least one data acquisition device and at least one control device.

The electrochemical sensor may be formed at least in part by screen printing. As used herein, the term "at least partially formed" means that the electrochemical sensor is completely formed by screen printing or that only portions of the electrochemical sensor may be formed by screen printing, wherein other portions of the electrochemical sensor may be formed by other production methods. The electronic device may be at least partially covered by at least one cover material. As used herein, the term "at least partially covered" means that the electronic device is completely covered by the covering material or only a portion of the electronic device may be covered by the covering material. The electronic device may be at least partially covered by an elastomer, in particular a two-component silicone and/or a two-component polyurethane and/or a resin. The electronic device may be at least partially covered by the adhesive layer. For example, the electronic device may be overmolded (over-molded) with an adhesive layer after being covered with a covering material, or vice versa. The adhesive layer may be configured to secure the electronic device to the body of the user. Additionally or alternatively, the medical device may include one or more mounting or securement devices for mounting or securing the medical device or a portion thereof (e.g., at least one electronic device) to the body of the user. As an example, the at least one mounting or securing means may be or may comprise at least one adhesive tape (e.g. plaster), and/or at least one strip or band. Thus, as an example, the substrate of the electronic device may be mounted to the skin of the user via at least one plaster and/or at least one strip or band. Other mounting or securing means are also possible and known to the person skilled in the art.

The implantable device may be made at least in part of a deformable material, such as a flexible material. As used herein, the term "made at least partially of a deformable material" refers to embodiments in which the implantable device may be made entirely of a deformable material, and embodiments in which only portions of the implantable device may be made of a deformable material are possible. The implantable device may include at least one deformable substrate, such as a flexible substrate. For potential embodiments of the flexible substrate, reference may be made to the possibilities disclosed above.

The medical device may further comprise at least one transcutaneous insertion element. The transcutaneous insertion member may comprise at least one skin penetrating member adapted to perforate the skin of the user. The transcutaneous insertion member may be adapted to guide the electrochemical sensor into body tissue of a user. The transcutaneous insertion member may be selected from the group consisting of an insertion needle and an insertion cannula. The transcutaneous insertion member may be fixedly mounted to the first portion of the housing. The transcutaneous insert member may be connected to the first portion of the housing by a moulding process, e.g. an insert moulding process (e.g. an injection insert moulding process). In the connected state of the first and second parts, the transcutaneous insertion element may be received inside the sterile packaging and may be sealed from the surroundings by the housing.

The implantable portion within the sterile package may be at least partially received within the lumen of the percutaneous insertion element. The term "lumen" may be understood to mean a cavity, such as an elongate cavity, disposed within a percutaneous insertion member. By way of example, the transcutaneous insertion member may comprise at least one slot, such as a fully or partially open slot, wherein a lumen may be formed within the slot. The implantable portion may be received wholly or partially within the channel. As used herein, the term "at least partially received inside the lumen" refers to at least a portion of the implantable portion insertable into the body tissue of a user, particularly a portion of an electrochemical sensor adapted to detect an analyte, more particularly an electrochemical sensor portion comprising electrodes of the electrochemical sensor, receivable inside the lumen of the transcutaneous insertion member. However, at least the interconnection of the implantable portion may be arranged outside the slot of the transcutaneous insertion member.

For example, the implantable device and/or implantable portion can be pre-bent. Thus, the pre-bent implantable portion may be guided into the groove such that parts of the implantable portion which are insertable into the body tissue of the user are arranged inside the groove and at least one contact portion is arranged outside the groove, e.g. extending at an angle to the longitudinal axis of the transcutaneous insertion member. As an example, the implantable device may be pre-bent such that the implantable portion forms an angle with the contact portion of 5 ° to 120 °, such as 10 ° to 90 ° or 20 ° to 70 °, wherein the angle may be measured with respect to an outer surface of the housing parallel to the longitudinal axis of the transcutaneous insertion member and in a direction towards a further device (e.g. a body patch) interacting with the implantable portion. Other arrangements are also possible. The interconnection portion may include a narrowed portion, wherein the narrowed portion allows the implantable portion within the lumen to connect to the contact portion. Thus, the elongated opening of the slot may be narrower than the wider portion inside the slot receiving the implantable portion, wherein the interconnection of the narrowed portion extends through the narrow slot to the outside of the slot.

The housing, e.g. the first part of the housing, may further comprise at least one mechanical interface through which the medical device may be connected to the insertion device. As used herein, the term "mechanical interface" generally refers to any element or combination of elements of a medical device that is adapted to interact with at least one mechanical interface of a second element to form a mechanical connection between the medical device and a further element, in particular an insertion device. The insertion device may be an inserter, i.e. a device adapted to mechanically insert the implantable portion into the body tissue of the user.

The mechanical interface may comprise at least one of: groove, constriction, hook, shoulder, protrusion, opening. In addition or alternatively, other types of mechanical interfaces may also be employed. The insertion device may comprise at least one drive mechanism for driving the skin penetrating element of the transcutaneous insertion element into the body tissue. As an example, the drive mechanism may comprise at least one actuator adapted to forcefully move the skin penetrating element through the skin into the body tissue. Thus, as an example, the drive mechanism may comprise at least one spring-based drive mechanism adapted to convert mechanical energy stored in the one or more springs into movement of the skin penetrating element. Drive mechanisms of this type are generally known in the art, for example from US 6,360,888B 1. Therefore, for specific details of embodiments of the drive mechanism, reference may be made to this patent document. However, other types of drive mechanisms may also or alternatively be used.

The insertion device may comprise at least one mechanical interface adapted to engage with a mechanical interface of the medical device. Thus, the insertion device may comprise at least one insertion device mechanical interface. The mechanical interface of the insertion device may be adapted to reversibly engage with the mechanical interface of the medical device, thereby forming a fixed spatial relationship between the medical device and the insertion device during insertion of the implantable portion into the body tissue. As used herein, the term "fixed spatial relationship" may generally refer to that in a connected state, the connected components (e.g., the mechanical interface of the medical device with the insertion device) form a connection unit comprising two components at a predetermined orientation and/or distance. These mechanical interfaces may be adapted to form a form-fit connection or a press-fit connection.

In another aspect, an insertion kit comprising at least one medical device according to the above medical device is disclosed. The insertion kit also includes at least one insertion device. The insertion device is adapted to mechanically interface with a medical device into a user's body tissue. As used herein, an "insertion set" is an assembly of components, wherein the components can function individually and can operate independently of each other, wherein the components of the insertion set can interact to perform one common function. Thus, the insertion set may comprise a plurality of components, wherein each component may be operated independently of the other components and independently perform at least one function, wherein furthermore all components or a group of components comprising at least two components may be combined, e.g. by physically connecting the components, so as to perform a common function meaning a function from the connected components. For the description of possible embodiments and the definition of medical device and insertion device, reference is made to the medical device and insertion device described above according to the invention.

In another aspect, a method for manufacturing a medical device is disclosed. The method comprises the method steps disclosed in more detail below. As an example, the method steps may be performed in a given order. However, a different order is also possible. Furthermore, one or more or even all of the method steps may be performed in parallel or in a temporally overlapping manner. Furthermore, one or more, or even all, of the method steps may be performed once or repeatedly.

The method includes providing at least one implantable device having at least one implantable portion adapted to be at least partially implanted in a body tissue of a user. The implantable device also has at least one contact portion connected to the implantable portion.

The method also includes providing at least one housing. The housing is configured to receive the implantable portion. The housing provides a sterile package to seal the implantable portion from the surrounding environment. The housing includes at least one first portion and at least one second portion.

The method further comprises removably connecting the first portion and the second portion to form an aseptic package, particularly (i.e. optionally) in a clean room or under clean room conditions or under other conditions. The first portion includes at least one first sealing surface and the second portion includes at least one second sealing surface. The first sealing surface interacts with the second sealing surface to form a sealing region. The implantable device has an interconnect connecting the implantable portion with the contact portion.

The method includes directing the interconnect through the sealing region.

For the description of possible embodiments and the definition of the device used in the method, reference is made to the above-described device according to the invention. Thus, the method may be suitable for producing a medical device according to one or more embodiments disclosed above and disclosed in more detail below. In addition, other embodiments are possible.

The removable connection of the first portion to the second portion may optionally be performed in a clean room or under clean room conditions. As used herein, the term "clean room" refers to an environment having controlled levels of environmental additives (e.g., environmental contaminants and/or pollutants). Generally, clean rooms or clean room environments can be classified according to the number of particles per volume of air. Several cleanroom standards are available, such as ISO 14644-1 cleanroom standard, BS 5295 cleanroom standard or GMP EU classification. As an example, clean room grades ISO 8 and D or higher may be used, respectively. The clean room may also be a sterile room and/or may provide a sterile environment.

The interconnect may be sandwiched between the first sealing surface and the second sealing surface. In an embodiment, the interconnect may be pressed onto one of the first or second sealing surfaces by the other of the first and second sealing surfaces.

The first portion may be connected to the second portion by one or both of a form-fit connection, a press-fit connection. The first and second portions may be fitted together such that one of the first and second portions may be interlocked in the other of the first and second portions. The first portion may be removed from the second portion in a removal direction along a longitudinal axis of the housing. Furthermore, the connection of the first part to the second part may be configured such that rotation and/or twisting about the longitudinal axis is not possible. The first portion and the second portion may be connected by a snap connection. The second portion of the housing may be removed from the housing prior to use.

The method may comprise at least one radiation sterilization step, wherein the implantable portion may be exposed to sterilizing radiation inside the housing during the radiation sterilization step. In general, the sterilization step may be any process in which microorganisms are killed and/or destroyed. In particular, the microorganisms may be killed and/or destroyed such that the microorganisms are no longer able to proliferate after the sterilization process. Here, the sterilization may be performed by irradiating the implantable portion with sterilizing radiation. In particular, the sterilizing radiation may be particle radiation. The sterilizing radiation may include: electron radiation, preferably beta radiation; electromagnetic radiation, preferably one or more of gamma radiation. For example, the electron radiation may have an energy of 1.0 MeV to 10 MeV, preferably 2 MeV to 3 MeV, and more preferably 2.5 MeV. By way of example, the sterilizing radiation may provide a dose of at least 10 kGy, such as at least 20 kGy or at least 25 kGy.

The contact portion may be adapted to provide at least one of a mechanical contact or an electrical contact to at least one further device interacting with the implantable device. The contact portion may include at least one electrical contact. The further device may comprise at least one electronic device, wherein the electronic device may be connected to the electrical contacts outside the sterile packaging. The implantable device may comprise at least one electrochemical sensor for electrochemical detection of at least one analyte in one or both of the body tissue or the body fluid, wherein the at least one electronic device may comprise at least one electronic device for measuring and/or recording a sensor signal generated by the electrochemical sensor. The electrochemical sensor may be formed at least in part by screen printing.

The method may include at least partially covering the electronic device with at least one cover material. The method may comprise at least partially covering the electronic device by an elastomer, in particular a two-component silicone and/or a two-component polyurethane and/or a resin. The method may include at least partially covering the electronic device with an adhesive layer. The capping process may be performed in a non-clean room environment.

The method can include a testing step in which the implantable device can be tested, such as prior to receiving the implantable portion in the housing. As used herein, a "testing step" may be any process in which various properties of an implantable device may be tested. In particular, electrochemical performance can be tested. In the testing step, the implantable device may be non-sterile. As used herein, the term "non-sterile" refers to the state of the implantable device prior to exposing the implantable device to a sterilization process, particularly prior to a radiation sterilization step.

The construction of the medical device may allow the method for producing the medical device according to the invention to be performed without sterilizing the electronic device. This abandonment of sterilization of electronic devices can lead to reduced production costs and logistical advantages. Alternatively, the electronic device may be wholly or partially sterilized by chemical sterilization, for example by gas sterilization using at least one sterilizing gas, for example by sterilization using ethylene oxide. Chemical sterilization may be performed after receiving the implantable portion in the housing and after sealing the implantable portion from the surrounding environment, such that the implantable portion remains unaffected by the chemical sterilization. The housing may be at least partially made of a gas impermeable material, preferably an ethylene oxide impermeable material.

The method may include at least one attachment step in which the electronic device may be connected to the at least one electrical contact by one or more of welding, soldering or bonding. The attaching step may be performed in a non-clean room environment. As used herein, a "non-clean room environment" may be any environment outside a clean room environment, in particular an environment filled with ambient air. In a preferred embodiment, the attaching step may be performed after a radiation sterilization step of the implantable device.

The medical device may further comprise at least one transcutaneous insertion element. The transcutaneous insertion member may be selected from the group consisting of an insertion needle and an insertion cannula. The transcutaneous insertion member may be fixedly mounted to the first portion of the housing. The transcutaneous insertion member may be connected to the first portion by a moulding process. The transcutaneous insertion member may be connected to the first part by an insert moulding process, e.g. an injection insert moulding process. In the connected state of the first and second parts, the transcutaneous insertion element may be received inside the sterile packaging and sealed from the surroundings by the housing. The implantable portion within the sterile package may be at least partially received within the lumen of the percutaneous insertion element. The transcutaneous insertion member may comprise at least one slot, wherein the implantable portion may be received within the slot. The interconnection portion may include a narrowed portion, wherein the narrowed portion may allow the implantable portion within the lumen to connect to the contact portion. The implantable portion may be pre-bent prior to receiving the implantable portion within the slot. Receiving the implantable portion inside the lumen of the percutaneous insertion element may be performed in a clean room.

The housing may further comprise at least one mechanical interface through which the medical device is connected to the insertion device. The insertion device may be an inserter. Connecting the medical device to the insertion device through the mechanical interface may be performed in a non-clean room environment.

In a preferred embodiment, the medical device may comprise an implantable portion, in particular an electrochemical sensor, which may be fixedly mounted together with the transcutaneous insertion element inside the housing, preferably the first portion of the housing. In the connected state of the first and second parts of the housing, the sealing area may ensure a protrusion of the interconnecting parts and may prevent the entry of microorganisms, in particular during further production steps after mounting of the first and second parts of the method for producing a medical device, and during storage periods. Thus, elements that have to be kept sterile can be arranged inside the housing. Further components, such as electronics and mechanical interfaces, can be arranged outside the housing. The housing, in particular the sterile packaging provided by the housing, allows for individual sterilization of the electrochemical sensor as well as the transcutaneous insertion member and the electronic device and ensures sterility during further production steps after mounting the first and second parts of the method for producing the medical device, and during storage periods. Thus, different sterilization methods can be applied, which are suitable for the components to be sterilized, and the implantable device and the electronic device can be installed in a non-clean room environment. Furthermore, the mechanical interface may ensure easy connection of the medical device with another device. The second portion of the housing may be removed from the housing prior to use.

Furthermore, in another preferred embodiment, the implantable portion may be arranged inside the housing and sterilized by a radiation sterilization step. In this preferred embodiment, electronics can be connected to the implantable device and the electronics can expose the implantable device assembly to a sterilizing gas, particularly EtO. The housing may be made at least in part of a gas impermeable material, in which case it is preferably an ethylene oxide impermeable material. Thus, the housing may ensure that the implantable device is prevented from being exposed to EtO. Thus, a medical device having a sterilized element inside the housing and sterilized electronics outside the housing can be produced.

Summarizing the findings of the present invention, the following examples are preferred:

example 1: a medical device comprising at least one implantable device having at least one implantable portion adapted to be at least partially implanted in a body tissue of a user, the implantable device further having at least one contact portion connected to the implantable portion, the medical device further comprising at least one housing, wherein the housing is configured to receive the implantable portion, wherein the housing is configured to provide a sterile package for sealing the implantable portion from the surrounding environment, wherein the housing comprises at least one first portion and at least one second portion, wherein the first portion is removably connected to the second portion to form the sterile package, wherein the first portion comprises at least one first sealing surface and wherein the second portion comprises at least one second sealing surface, wherein the first sealing surface interacts with the second sealing surface to form a sealed area, wherein the implantable device has an interconnection connecting the implantable portion with the contact portion, wherein the interconnection leads through the sealing region.

Example 2: the medical device according to the previous embodiment, wherein the implantable device comprises at least one of the following: an implantable sensor, a cannula, a tube for detecting at least one analyte in a body tissue.

Example 3: the medical device of any one of the preceding embodiments, wherein the interconnect is sandwiched between the first sealing surface and the second sealing surface.

Example 4: the medical device of any one of the preceding embodiments, wherein the interconnect is pressed onto one of the first sealing surface or the second sealing surface by the other of the first sealing surface and the second sealing surface.

Example 5: the medical device of any one of the preceding embodiments, wherein the first sealing surface and the second sealing surface are annular sealing surfaces.

Example 6: the medical device of any one of the preceding embodiments, wherein the housing is at least partially cylindrical.

Example 7: the medical device of the previous embodiment, wherein the housing has a longitudinal axis, wherein the implantable portion received inside the sterile package extends at least partially parallel to the longitudinal axis.

Example 8: the medical device of the previous embodiment, wherein the contact portion is at least partially curved away from the longitudinal axis.

Example 9: the medical device of any one of the preceding embodiments, wherein the housing is at least partially made of a rigid material.

Example 10: the medical device of any one of the preceding embodiments, wherein one or both of the first and second portions are at least partially made of a deformable material in the sealing region.

Example 11: the medical device according to the previous embodiment, wherein the deformable material is selected from the group consisting of elastic materials, thermoplastic elastomers.

Example 12: the medical device of any one of the preceding embodiments, wherein the housing is at least partially made of a gas impermeable material.

Example 13: the medical device of any one of the preceding embodiments, wherein the first portion and the second portion are connectable by one or both of a form-fit connection, a press-fit connection.

Example 14: the medical device of any one of the preceding embodiments, wherein the first portion and the second portion are connectable by a snap-fit connection.

Example 15: the medical device of any one of the preceding embodiments, wherein one or both of the first and second portions includes at least one sealing lip.

Example 16: the medical device of any one of the preceding embodiments, wherein the contact portion is adapted to provide at least one of a mechanical contact or an electrical contact to at least one further device interacting with the implantable device.

Example 17: the medical device of the previous embodiment, wherein the contact portion comprises at least one electrical contact.

Example 18: the medical device according to the previous embodiment, wherein the further device comprises at least one electronic device, wherein the electronic device is connected to the electrical contacts outside the sterile packaging.

Example 19: the medical device according to the previous embodiment, wherein the implantable device comprises at least one electrochemical sensor for electrochemical detection of at least one analyte in one or both of the body tissue or the body fluid, wherein the at least one electronic device comprises at least one electronic device for measuring and/or recording a sensor signal generated by the electrochemical sensor.

Example 20: the medical device of the previous embodiment, wherein the electrochemical sensor is formed at least in part by screen printing.

Example 21: the medical device of any one of the three preceding embodiments, wherein the electronic device is at least partially covered by at least one covering material.

Example 22: the medical device according to any one of the four preceding embodiments, wherein the electronic device is at least partially covered by an elastomer, in particular a two-component silicone and/or a two-component polyurethane and/or a resin.

Example 23: the medical device of any one of the five previous embodiments, wherein the electronic device is at least partially covered by an adhesive layer.

Example 24: the medical device of any of the preceding embodiments, wherein the implantable device is at least partially made of a deformable material.

Example 25: the medical device according to the previous embodiment, wherein the implantable device comprises at least one deformable substrate.

Example 26: the medical device of any of the preceding embodiments, wherein the medical device further comprises at least one transcutaneous insertion element.

Example 27: the medical device according to the previous embodiment, wherein the transcutaneous insertion member is selected from the group consisting of an insertion needle and an insertion cannula.

Example 28: the medical device according to any one of the two preceding embodiments, wherein the transcutaneous insertion element is fixedly mounted to the first part of the housing.

Example 29: the medical device according to the previous embodiment, wherein the transcutaneous insertion element is connected to the first part by a moulding process.

Example 30: the medical device of any one of the four preceding embodiments, wherein in the connected state of the first and second portions, the transcutaneous insertion element is received inside the sterile packaging and sealed from the surroundings by the housing.

Example 31: the medical device of any one of the five preceding embodiments, wherein the implantable portion within the sterile package is at least partially received within the lumen of the percutaneous insertion element.

Example 32: the medical device of the previous embodiment, wherein the transcutaneous insertion member comprises at least one slot, wherein the implantable portion is received within the slot.

Example 33: the medical device according to any of the two preceding embodiments, wherein the interconnection portion comprises a narrowing, wherein the narrowing allows connecting the implantable portion inside the lumen to the contact portion.

Example 34: the medical device of any of the preceding embodiments, wherein the housing further comprises at least one mechanical interface, wherein the medical device is connectable to the insertion device through the mechanical interface.

Example 35: the medical device according to the previous embodiment, wherein the insertion device is an inserter.

Example 36: the medical device of any one of the two preceding embodiments, wherein the mechanical interface comprises at least one of: groove, constriction, hook, shoulder, protrusion, opening.

Example 37: an insertion kit comprising at least one medical device according to any of the preceding embodiments, further comprising at least one insertion device, wherein the insertion device is adapted to mechanically interface with the medical device and is adapted to at least partially implant an implantable portion of the medical device into a body tissue of a user.

Example 38: a method for producing a medical device, the method comprising providing at least one implantable device having at least one implantable portion adapted to be at least partially implanted into a body tissue of a user, the implantable device further having at least one contact portion connected to the implantable portion, the method further comprising providing at least one housing, wherein the housing is configured to receive the implantable portion, the housing providing sterile packaging for sealing the implantable portion from the surrounding environment, wherein the housing comprises at least one first portion and at least one second portion; the method further includes removably connecting the first portion with the second portion to form an aseptic package, wherein the first portion includes at least one first sealing surface and wherein the second portion includes at least one second sealing surface, wherein the first sealing surface interacts with the second sealing surface to form a sealed area, wherein the implantable device has an interconnecting portion connecting the implantable portion with the contact portion; wherein the method comprises guiding the interconnection through the sealing area.

Example 39: the method according to the preceding embodiment, wherein the removable connection of the first and second sections is performed in a clean room or under clean room conditions.

Example 40: the method according to any of the preceding embodiments directed to methods, wherein the interconnection is sandwiched between the first sealing surface and the second sealing surface.

Example 41: the method according to the preceding embodiment, wherein the interconnection is pressed onto one of the first or second sealing surface by the other of the first and second sealing surface.

Example 42: the method of any of the preceding embodiments directed to methods, wherein the first portion is connected to the second portion by one or both of a form-fit connection, a press-fit connection.

Example 43: the method of any of the preceding embodiments directed to methods, wherein the first portion is connected to the second portion by a snap-fit connection.

Example 44: the method according to any of the preceding embodiments, comprising at least one radiation sterilization step, wherein the implantable portion is exposed to sterilizing radiation inside the housing during the radiation sterilization step.

Example 45: the method of the preceding embodiment, wherein the sterilizing radiation comprises one or more of the following: electron radiation, preferably beta radiation; electromagnetic radiation, preferably gamma radiation.

Example 46: the method according to any of the preceding embodiments directed to methods, wherein the contact portion is adapted to provide at least one of a mechanical contact or an electrical contact to at least one further device interacting with the implantable device.

Example 47: the method of the preceding embodiment, wherein the contact portion comprises at least one electrical contact.

Example 48: the method of the preceding embodiment, wherein the additional device comprises at least one electronic device, wherein the electronic device is connected to the electrical contacts outside the sterile package.

Example 49: the method according to the preceding embodiment, wherein the implantable device comprises at least one electrochemical sensor for electrochemical detection of at least one analyte in one or both of the body tissue or the body fluid, wherein the at least one electronic device comprises at least one electronic device for measuring and/or recording a sensor signal generated by the electrochemical sensor.

Example 50: the method of the preceding embodiment, wherein the electrochemical sensor is formed at least in part by screen printing.

Example 51: the method according to any one of the three preceding embodiments, comprising at least partially covering the electronic device by at least one covering material.

Example 52: the method according to any one of the four preceding embodiments, comprising at least partially covering the electronic device with an elastomer, in particular a two-component silicone and/or a two-component polyurethane and/or a resin.

Example 53: the method of any one of the five preceding embodiments, comprising at least partially covering the electronic device with an adhesive layer.

Example 54: the method according to any of the six preceding embodiments, wherein the method comprises a testing step, wherein the implantable device is preferably tested before the implantable portion is received in the housing.

Example 55: the method of the preceding embodiment, wherein the implantable device is non-sterile during the testing step.

Example 56: the method of any one of the eight preceding embodiments, wherein the electronic device is sterilized by chemical sterilization, preferably by gas sterilization using at least one sterilizing gas, more preferably by sterilization using ethylene oxide.

Example 57: the method of the preceding embodiment, wherein the chemical sterilization is performed after receiving the implantable portion in the housing and after sealing the implantable portion from the surrounding environment such that the implantable portion remains unaffected by the chemical sterilization.

Example 58: the method of any of the ten preceding embodiments, comprising at least one attaching step in which the electronic device is connected to the at least one electrical contact by one or more of welding, soldering, or bonding.

Example 59: the method of any one of eleven preceding embodiments, wherein the attaching step is performed in a non-clean room environment.

Example 60: the method of any of the two preceding embodiments, wherein the attaching step is performed after a radiation sterilization step of the implantable device.

Example 61: the method of any of the preceding embodiments directed to methods, wherein the medical device further comprises at least one transcutaneous insertion member.

Example 62: the method of the preceding embodiment, wherein the transcutaneous insertion member is selected from the group consisting of an insertion needle and an insertion cannula.

Example 63: the method according to any of the two preceding embodiments, wherein the transcutaneous insertion element is fixedly mounted to the first portion of the housing.

Example 64: the method according to the previous embodiment, wherein the transcutaneous insertion element is connected to the first part by a moulding step.

Example 65: the method of any of the four preceding embodiments, wherein in the connected state of the first and second portions, the transcutaneous insertion element is received inside the sterile packaging and sealed from the surroundings by the housing.

Example 66: the method of any of the five preceding embodiments, wherein the implantable portion inside the sterile package is at least partially received inside a lumen of the percutaneous insertion element.

Example 67: the method of the preceding embodiment, wherein the percutaneous insertion element includes at least one slot, wherein the implantable portion is received in the slot.

Example 68: the method according to any of the two preceding embodiments, wherein the interconnection comprises a narrowing, wherein the narrowing allows the implantable portion inside the lumen to connect to the contact portion.

Example 69: the method of any of the two preceding embodiments, wherein the implantable device and/or the implantable portion are pre-bent prior to receiving the implantable portion within the slot.

Example 70: the method of any of the four preceding embodiments, wherein receiving the implantable portion inside the lumen of the percutaneous insertion element is performed in a clean room.

Example 71: the method according to any of the preceding embodiments related to the method, wherein the housing further comprises at least one mechanical interface, wherein the medical device is connected to the insertion device through the mechanical interface.

Example 72: the method according to the preceding embodiment, wherein the insertion device is an inserter.

Example 73: the method according to any of the two preceding embodiments, wherein connecting the medical device to the insertion device through the mechanical interface is performed in a non-clean room environment.

Drawings

Further optional features and embodiments of the invention will be disclosed in more detail in the subsequent description of preferred embodiments, preferably in conjunction with the dependent claims. Wherein the respective optional features may be implemented individually as well as in any feasible combination, as will be appreciated by a person skilled in the art. The scope of the invention is not limited by these preferred embodiments. The embodiments are schematically shown in the drawings. In which like reference numerals refer to identical or functionally comparable elements throughout the separate views.

In the drawings:

fig. 1 shows an embodiment of an insertion set according to the invention comprising at least one medical device;

FIG. 2 shows an embodiment of a removable connection of a first portion and a second portion of a housing according to the present invention;

fig. 3 shows a diagrammatic view of a method for producing a medical device according to the invention.

Detailed Description

In fig. 1, an embodiment of an insertion set 110 comprising at least one medical device 112 according to the present invention is shown. The kit 110 comprises at least one insertion device 114, only symbolically shown in fig. 1. The insertion device 114 may be an inserter (serter). The medical device 112 includes at least one housing 116. The housing may be at least partially made of a rigid material. The housing 116 includes at least one first portion 118 and at least one second portion 120. First portion 118 and second portion 120 are removably connected to form a sterile package. In fig. 1, an embodiment is shown in which the first portion 118 and the second portion 120 may be in a connected state. The first portion 118 and the second portion 120 may be connected by one or both of a positive fit connection, a press fit connection.

Fig. 2 shows an embodiment of a removable connection of the first portion 118 and the second portion 120 of the housing 116 according to the invention. The first portion 118 includes at least one first sealing surface 122 and the second portion 120 includes at least one second sealing surface 124. The first and second sealing surfaces 122, 122 may be annular sealing surfaces. The first sealing surface 122 interacts with the second sealing surface 124 to form a sealing region 126. The medical device 112 includes at least one implantable device 128 having at least one implantable portion 130 adapted to be at least partially implanted in a user's body tissue. The implantable device 128 may include at least one of the following: an implantable sensor, a cannula, a tube for detecting at least one analyte in a body tissue. The housing 116 is configured to receive the implantable portion 130. The housing 116 is configured to provide a sterile package to seal the implantable portion 130 from the surrounding environment. In particular, the housing may ensure that the implantable portion 130 is protected from microorganisms. Implantable device 128 also has at least one contact portion 132 connected to implantable portion 130. Implantable device 128 has an interconnect 134 that connects implantable portion 130 with contact portion 132. The contact portion 132 may be adapted to provide at least one of a mechanical contact or an electrical contact to at least one further device 136 interacting with the implantable device 114, such as outlined in fig. 1. The contact portion may include at least one electrical contact 138.

The interconnect 134 leads through the sealing region 126. The interconnect 134 may be sandwiched between the first and second sealing surfaces 122, 124. The interconnect 130 is pressed onto one of the first and second sealing surfaces 126, 124 with the other of the first and second sealing surfaces 124, 126. The housing 116 may be at least partially made of a rigid material. Preferably, one or both of first portion 118 and second portion 120, in sealing region 126, may be made at least partially of a deformable material, preferably an elastic material. The deformable material may be selected from the group consisting of elastic materials, thermoplastic materials (e.g. polypropylene), thermoplastic elastomers. In a preferred embodiment, the first portion 118 and the second portion 120 may include sealing lips.

In fig. 2, an embodiment is shown wherein the first portion 118 and the second portion 120 may be connected by a snap-fit connection. For example, the first portion 118 and the second portion 120 may be configured according to the principles of a lock and key. The first portion 118 may be partially inserted into one or more cavities inside the second portion; an opening of the second portion; a mounting element of the second section; a receiving element of the second section. The second portion 120 may include at least one of: a groove, a narrowing, a hook, a shoulder, a protrusion, an opening; wherein the first portion 118 may include a counterpart. Further, one of the first portion 118 and the second portion 120 may be configured such that twisting or rotational movement of the first portion 118 may be prevented.

The housing 116 shown in fig. 1 may be at least partially cylindrical. The housing 116 may have a longitudinal axis 140, wherein the implantable portion 130 received inside the sterile package may extend at least partially parallel to the longitudinal axis 140, preferably along the longitudinal axis 140. The contact portion 132 may be at least partially curved away from the longitudinal axis 140. The further device 136 may comprise at least one electronic device 142, wherein the electronic device 142 may be connected to the electrical contacts 138 outside the sterile packaging.

The housing 116 may include at least one mechanical interface 144. The medical device 112 may be connected to the insertion device 114 using a mechanical interface 144. The mechanical interface 144 may include at least one of: groove, constriction, hook, shoulder, protrusion, opening. In the embodiment shown in fig. 1, the mechanical interface 144 may comprise a groove.

With regard to further embodiments of the insertion kit 110 and the medical device 112 according to the invention, reference may be made to the following description (fig. 3) of an overview of a method for manufacturing the medical device 112 according to the invention.

Fig. 3 shows a diagrammatic view of an exemplary method for manufacturing the medical device 112. First, an implantable device 128 may be provided, as shown in partial view a of fig. 3. The implantable device 128 may include at least one electrochemical sensor 146 for electrochemically detecting an analyte in one or both of body tissue or fluid. The electrochemical sensor may be formed at least in part by screen printing. The implantable device 128 may be made of a deformable material, preferably a flexible material. The implantable device 128 may include at least one deformable substrate, preferably a flexible substrate. The method, such as step a, may include a testing step in which the implantable device 128 may be tested. For example, the electrochemical performance of the electrochemical sensor 146 may be tested. In this testing step, the implantable device 128 may be non-sterile.

In addition, the medical device 112 may include at least one transcutaneous insertion member 148, as shown in partial view B of FIG. 3. The transcutaneous insertion member 148 may be selected from the group consisting of an insertion needle and an insertion cannula. The transcutaneous insertion member 148 may be fixedly mounted to the first portion 118 of the housing 116. For example, the transcutaneous insert member 148 may be coupled to the first portion 118 via a molding process, such as an insert molding process (e.g., an injection insert molding process). Implantable portion 130, within the sterile package, may be at least partially received within lumen 150 of percutaneous insertion member 148. The transcutaneous insertion member 148 may include at least one channel 152, with the implantable portion 130 being received within the channel 152. The interconnecting portion 134 may include a narrowed portion that may allow the implantable portion 134 inside the lumen 150 to be connected to the contact portion 132. Implantable portion 130 can be pre-bent before implantable portion 130 can be received in slot 152 and can be inserted into slot 152. Reference numeral 154 denotes an insertion direction of the pre-bent implantable portion 130. Receiving implantable portion 130 inside lumen 150 of percutaneous insertion element 148 may be performed in a clean room.

Next, as shown in partial view C of FIG. 3, first portion 118 may be removably connected with second portion 120. The removable connection of the first portion 118 and the second portion 120 may be performed in a clean room. The first sealing surface 122 interacts with the second sealing surface 124 to form a sealing region 126. The interconnect 134 may be sandwiched between the first and second sealing surfaces 122, 124. The first portion 118 and the second portion 120 may be connected using one or both of a form-fit connection, a press-fit connection. Reference numeral 156 denotes a connecting direction of the first portion 118 and the second portion 120. In the connected state of the first and second portions 118, 120, the transcutaneous insertion element 148 may be received inside the sterile packaging and may be sealed from the surrounding environment by the housing 116. The housing provides a sterile package to seal the implantable portion 130 from the surrounding environment. The method may include at least one radiation sterilization step, wherein the implantable portion 130 may be exposed to sterilizing radiation within the housing 116 during the radiation sterilization step. The sterilizing radiation may comprise electron radiation, preferably beta-radiation; electromagnetic radiation, preferably one or more of gamma radiation.

Further, as shown in partial D of fig. 3, the method may include at least one attachment step in which the electronic device 142 may be connected to the at least one electronic contact 138 using one or more of welding, soldering, or bonding. Additional devices 136 may be connected to the implantable device 128. The contact portion 132 may be adapted to provide at least one of a mechanical contact or an electrical contact to a further device 136 that interacts with the implantable device 128. Accordingly, the contact portion 132 may include at least one electrical contact 138. The further device 136 may comprise at least one electronic device 142. The at least one electronic device 142 may include at least one electronic device for measuring and/or recording sensor signals generated by the electrochemical sensor 146. The electronics 142 may be connected to the electrical contacts 138 outside the sterile package. The attaching step may be performed in a non-clean room environment. This attachment step may be performed after the radiation sterilization step of the implantable device 128.

If an application requires that the electronics 142 be sterile, the electronics 142 may be sterilized by chemical sterilization, preferably by gas sterilization using at least one sterilizing gas, more preferably by sterilization using ethylene oxide. Chemical sterilization is performed after receiving implantable portion 130 in housing 116 and after sealing implantable portion 130 from the surrounding environment, such that implantable portion 130 remains unaffected by the chemical sterilization. The housing 116 may be at least partially made of a gas impermeable material, preferably an ethylene oxide impermeable material.

Further, as shown in partial fig. E of fig. 3, the method may include at least partially covering the electronic device 142 with at least one cover material 158. In a preferred embodiment, the method may include at least partially covering the electronic device 142 with an elastomer (particularly a two-component silicone and/or a two-component polyurethane and/or a resin). Further, the method may include at least partially covering the electronic device 142 with an adhesive layer not shown in the figures. The capping process may be performed in a non-clean room environment.

Further, as shown in partial view F of fig. 3, the medical device 112 may be connected to the insertion device 114 using a mechanical interface 144. The insertion device 144 may be an inserter. For example, the medical device 112 may be at least partially introduced into the insertion device 114. Reference numeral 160 denotes a guide direction. Connecting the medical device 112 to the insertion device 114 through the mechanical interface 144 may be performed in a non-cleanroom environment.

List of reference numerals

110 insertion set

112 medical device

114 insertion device

116 casing

118 first part

120 second part

122 first sealing surface

124 second sealing surface

126 sealing area

128 implantable device

130 implantable portion

132 contact part

134 interconnect

136 further device

138 electrical contact

140 longitudinal axis

142 electronic device

144 mechanical interface

146 electrochemical sensor

148 percutaneous insertion element

150 inner cavity

152 groove

154 direction of insertion

156 direction of connection

158 covering material

160 guide direction

Claims (15)

1. A medical device (112) comprising at least one implantable device (128), the at least one implantable device (128) having at least one implantable portion (130) adapted to be at least partially implanted into a user's body tissue, the implantable device (128) further having at least one contact portion (132) connected to the implantable portion (130), the medical device (112) further comprising at least one housing (116), wherein the housing (116) is configured to receive the implantable portion (130), wherein the housing (116) is configured to provide a sterile package for sealing the implantable portion (130) from the surrounding environment, wherein the housing (116) comprises at least one first portion (118) and at least one second portion (120), wherein the first portion (118) is removably connectable to the second portion (120) to form the sterile package, wherein the first portion (118) comprises at least one first sealing surface (122) and wherein the second portion (120) comprises at least one second sealing surface (124), wherein the first sealing surface (122) interacts with the second sealing surface (124) to form a sealing region (126), wherein the implantable device (128) has an interconnection portion (134) connecting the implantable portion (130) with the contact portion (132), wherein the interconnection portion (134) leads through the sealing region (126).

2. The medical device (112) according to the preceding claim, wherein the implantable device (128) comprises at least one of: an implantable sensor, cannula, tube for detecting at least one analyte in one or both of a body tissue or fluid.

3. The medical device (112) according to any one of the preceding claims, wherein the interconnect (134) is sandwiched between the first and second sealing surfaces (122, 124).

4. The medical device (112) according to any one of the preceding claims, wherein the housing (116) is at least partially cylindrical, wherein the housing (116) has a longitudinal axis (140), wherein the implantable portion (130) received inside the sterile package extends at least partially parallel to the longitudinal axis (140).

5. The medical device (112) according to the preceding claim, wherein the contact portion (132) is at least partially bent away from the longitudinal axis (140).

6. The medical device (112) according to any one of the preceding claims, wherein the first portion (118) and the second portion (120) are connectable by one or two of a form-fit connection, a press-fit connection, a snap-fit connection.

7. The medical device (112) according to any one of the preceding claims, wherein the contact portion (132) is adapted to provide at least one of a mechanical contact or an electrical contact to at least one further device (136) interacting with the implantable device (128), wherein the contact portion (132) comprises at least one electrical contact (138), wherein the further device (136) comprises at least one electronic device (42), wherein the electronic device (142) is connected to the electrical contact (138) outside the sterile packaging.

8. The medical device (112) according to the preceding claim, wherein the implantable device (128) comprises at least one electrochemical sensor (146) for electrochemical detection of at least one analyte in one or both of a body tissue or a body fluid, wherein the at least one electronic device (142) comprises at least one electronic device for measuring and/or recording a sensor signal generated by the electrochemical sensor (146).

9. The medical device (112) according to any one of the preceding claims, wherein the medical device (112) further comprises at least one transcutaneous insertion element (148), wherein the transcutaneous insertion element (148) is fixedly mounted to the first portion (118) of the housing (116).

10. An insertion kit (110) comprising at least one medical device (112) according to any one of the preceding claims, further comprising at least one insertion device (114), wherein the insertion device (114) is adapted to mechanically interface with the medical device (112) and to at least partially implant at least one implantable portion (130) of the medical device (112) into a user's body tissue.

11. A method for manufacturing a medical device (112), the method comprising providing at least one implantable device (128), the at least one implantable device (128) having at least one implantable portion (130) adapted to be at least partially implanted into a body tissue of a user, the implantable device (128) further having at least one contact portion (132) connected to the implantable portion (130); the method further includes providing at least one housing (116), wherein the housing (116) is configured to receive the implantable portion (130), the housing (116) providing sterile packaging to seal the implantable portion (130) from the surrounding environment, wherein the housing (116) includes at least one first portion (118) and at least one second portion (120); the method further comprises removably connecting the first portion (118) with the second portion (120), in particular in a clean room or under clean room conditions, to form the aseptic package, wherein the first portion (118) comprises at least one first sealing surface (122) and wherein the second portion (120) comprises at least one second sealing surface (124), wherein the first sealing surface (122) and the second sealing surface (124) interact to form a sealed area (126), wherein the implantable device (128) has an interconnection (134) connecting the implantable portion (130) with the contact portion (132), wherein the method comprises guiding the interconnection (134) through the sealed area (126).

12. The method according to any one of the preceding method claims, comprising at least one radiation sterilization step, wherein the implantable portion (130) is exposed to sterilizing radiation inside the housing (116) in the radiation sterilization step.

13. The method according to any of the preceding method claims, wherein the contact portion (132) comprises at least one electrical contact (138) to be connected to at least one further device (136), wherein the further device (136) comprises at least one electronic device (142), wherein the electronic device (142) is connected to the electrical contact (138) outside the sterile packaging, wherein the electronic device (142) is sterilized by chemical sterilization, wherein the chemical sterilization is performed after receiving the implantable portion (130) in the housing (116) and after sealing the implantable portion (130) from the surrounding environment, such that the implantable portion (130) remains unaffected by the chemical sterilization.

14. The method of the preceding claim, comprising at least one attaching step, wherein the electronic device (142) is connected to the at least one electrical contact (138) by one or more of welding, soldering or bonding, wherein the attaching step is performed in a non-clean room environment.

15. The method according to the preceding claim, wherein the attaching step is performed after a radiation sterilization step of the implantable device (128).