Medical device and method for monitoring integrity of housing of medical device

Abstract

A medical device (112) having at least one invasive portion (124) is disclosed. The medical device (112) includes at least one housing (114) at least partially surrounding at least one closed chamber (116). The closed chamber (116) is configured to maintain a pressure difference between at least one interior (118) of the closed chamber (116) and an ambient environment (120). The housing (114) includes at least one deformable member (122). The housing (114) is configured such that a deformed state of the deformable member (122) provides a measurable indication of the pressure difference between the inner cavity (118) of the enclosed chamber (116) and the ambient environment (120).

Description

Technical Field

[0001] This invention relates to medical devices, kits, and methods for monitoring the integrity of the housing of the medical device. The medical device can be applied to the field of continuous monitoring of analytes in a user's bodily fluids, particularly in home care and professional care settings, such as in hospitals. However, other applications are also possible. Background Technology

[0002] Sterile medical devices intended for patients typically require sterility testing during manufacturing. Direct sterility testing is generally destructive. Therefore, the medical device is usually removed from its sterile packaging and its sterility is checked. This method is generally not suitable for quality control during production because the tested product cannot be resold.

[0003] Alternatively, validated manufacturing processes and application materials of known quality can be used. With this approach, all manufacturing parameters that may affect sterility are typically assessed and monitored. Products manufactured using tested parameters are expected to have the same sterility properties as samples from a single destructive test. However, if the product is transported after manufacturing or subjected to other stressful events, the integrity of the packaging can no longer be assumed to be 100%.

[0004] As a further approach, an indirect method can be applied. Therefore, instead of directly examining sterility, the protective mechanisms that maintain sterility are examined. Sterile products that arrive in intact packaging can still be considered sterile.

[0005] An established method for determining the integrity of sterile containers operates on the principle of volume determination based on pressure testing according to Boyle-Mariotte's law. Thus, an unknown volume V2 can be determined using a known volume V1 and a known initial pressure. If the volume V2 in the testing apparatus is designed with a test chamber of known constant volume, the additional volume of the inserted test sample can be determined. The known volume V2 of the test chamber is subtracted from the volume of the test sample. If the volume of the test sample is also known (e.g., determined from the sample itself), a closed test sample can be distinguished from a leaking test sample. In a leaking sample, the internal volume of its sterile chamber can withstand pressure and does not reduce volume V2. A closed test sample reduces volume V2 not only by its solids content but also by the sealed volume within its sterile chamber. This type of test is described in standards such as DIN EN 1779.

[0006] According to existing technology, test methods for testing watch leaks are also known. For this purpose, the watch to be tested is placed in a pressure chamber, and the case thickness corresponding to the distance between the crystal and the case back is measured. If the distance remains constant during pressurization, the watch case is leaking. The watch is like a pressure vessel, and its thickness can be measured.

[0007] WO2022147329A1 describes a sensor control device for analyte monitoring, comprising an electronics housing having a shell defining a top surface and a mounting member defining a bottom surface of the housing. An adhesive patch attached to the bottom surface defines a central opening and includes a first layer facing the mounting member and a second layer facing the user's skin. The first layer has a first hole, and the second layer has a second hole, and the first and second holes are aligned with the central opening along the vertical axis of the sensor control device. The first or second layer includes laser-cut grooves or laser-cut holes configured for fluid drainage or skin permeability.

[0008] US20220080678A1 describes a method comprising assembling a sensor subassembly including a sensor, a sensor mount, a collar, a tip, and a sensor cap. The method includes loading the sensor into the sensor mount; dispensing adhesive into mounting channels of the sensor mount; clamping the collar to the sensor mount; and curing the adhesive to secure the collar to the sensor mount. The method may also include inserting the tip into the sensor mount above the sensor and attaching the sensor cap to the sensor and the sensor tip to provide a sealing of the sensor subassembly. Methods for assembling sensor disk assemblies and applicator assemblies on an assembly are also disclosed, as well as a sensor including a tail, a flag, and an interconnecting neck of the tail and flag, and a method for configuring the sensor.

[0009] EP2982383B1 describes assembling an analyte sensor with an analyte sensor insert, packaging the assembled analyte sensor and sensor insert in a substantially hermetically sealed enclosure, and irradiating the packaged assembled analyte sensor and sensor insert with a predetermined dose using one or more electron beam accelerators.

[0010] Despite the advantages of the aforementioned devices, several technical challenges remain. According to existing technologies, the sterility of a product is verified through destructive or indirect methods. Destructive testing is generally unsuitable for manufacturing processes if 100% control is desired. Furthermore, medical devices in the field of continuously monitoring analytes in a user's bodily fluids typically include a sterile chamber housing the analyte sensor, and additionally, an additional enclosed volume, i.e., the volume surrounded by an electronics housing. The electronics housing typically does not need to meet sterile airtightness requirements, but it must generally be waterproof and dustproof. A drawback of the aforementioned integrity testing methods is the influence of this additional enclosed volume (i.e., the volume enclosed by the electronics housing) on ​​the measurement results. A leaking electronics housing can produce the same measurement effect on the analyte sensor as a leaking sterile chamber. Therefore, such test results are generally not selective for either the sterile chamber with the analyte sensor or the chamber enclosed by the electronics housing.

[0011] Test methods based on the "pressure vessel" principle with length measurement as described above are generally not suitable for testing the integrity of sterile chambers with analyte sensors, because the high strength of the sterile chamber combined with its small surface area usually results in very small deflections.

[0012] Problems to be solved

[0013] Therefore, it is desirable to provide a medical device, kit, and method for monitoring the integrity of the housing of the medical device, which at least partially addresses the aforementioned technical challenges. Specifically, it is desirable to provide a medical device, kit, and method for monitoring the integrity of the housing of the medical device, which allows for reliable and non-destructive monitoring of the integrity of the housing of the medical device. Summary of the Invention

[0014] This problem is addressed by medical devices, kits, and methods for monitoring the integrity of the housing of the medical device, having the features of the independent claims. Advantageous embodiments that can be implemented individually or in any combination are set forth in the dependent claims and throughout the specification.

[0015] As used below, the terms “have,” “contain,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer either to a situation where no other features exist in the entity described in this context besides those introduced by these terms, or to a situation where one or more other features exist. For example, the statements “A has B,” “A includes B,” and “A contains B” can refer to a situation where no other elements exist in A besides B (i.e., where A is solely and uniquely composed of B); or to a situation where one or more other elements (such as element C, element D, or even other elements) exist in entity A besides B.

[0016] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist once or more are generally used only once when the corresponding feature or element is introduced. In the following text, in most cases, when referring to a corresponding feature or element, the expressions "at least one" or "one or more" will not be used repeatedly, even though the corresponding feature or element may exist only once or more.

[0017] Furthermore, as used below, the terms “preferredly,” “more preferably,” “particularly,” “more particularly,” “specifically,” “more specifically,” or similar terms are used in combination with optional features without limiting the possibility of alternatives. Therefore, 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 recognize, the invention can be implemented by using alternative features. Similarly, features introduced by “in one embodiment of the invention” or similar expressions are intended to be optional features without limiting alternative embodiments of the invention, without limiting the scope of the invention, and without limiting the possibility of combining features introduced in this way with other optional or non-optional features of the invention.

[0018] As used herein, the term "user" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to a person who wants to monitor analyte values ​​(such as glucose levels) in a person's body tissues and / or deliver medications (such as insulin) into a person's body tissues. In one embodiment, the term may specifically refer to, but is not limited to, a person using a medical device. However, in one embodiment, the person using the medical device is different from the user. For example, the medical device or a portion thereof may be inserted into the user's body tissue by a person different from the user. For example, the user may be a patient suffering from a condition such as diabetes.

[0019] As used herein, the term "body fluid" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term refers to any fluid that is generally present in the body or body tissues of a user or patient and / or can be produced by the body of a user or patient. An example of body tissue may be named interstitial tissue. Thus, as an example, body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of body fluids, such as saliva, tears, urine, or other body fluids, may be used. Body fluid may be present in the body or body tissues during the detection of at least one analyte.

[0020] In a first aspect of the invention, a medical device having at least one invasive portion is disclosed. The medical device includes at least one housing at least partially surrounding at least one sealed chamber. The sealed chamber is configured to maintain a pressure difference between at least one interior cavity of the sealed chamber and the surrounding environment. The housing includes at least one deformable member. The housing is configured such that the deformation state of the deformable member provides a measurable indication of the pressure difference between the interior cavity of the sealed chamber and the surrounding environment.

[0021] As used herein, the term "medical device" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or custom-defined meaning. Specifically, the term may refer to, but is not limited to, any element or object constructed for use in the field of medical technology, specifically in the fields of medical analysis or medical diagnosis. A medical device may be constructed to perform at least one medical function and / or to be used in at least one medical procedure, such as a treatment procedure, a diagnostic procedure, or one or more other medical procedures.

[0022] The medical device can be configured to be installed on a skin portion of a user's limb. The limb can be selected from the following groups: arm, specifically the upper arm; abdomen; shoulder; back; hip; leg. Specifically, the limb can be the upper arm. However, other applications are also possible.

[0023] The medical device may further include at least one component that can be configured to remain outside of body tissue. Further, as described above, the medical device includes at least one invasive portion. The invasive portion may be configured for insertion into the user's body tissue.

[0024] The medical device may be selected from the group consisting of: a pharmaceutical device for delivering at least one therapeutic medical fluid to a user, specifically a device for delivering insulin to a user; and a device for detecting at least one analyte in a user's bodily fluids, specifically a device for detecting glucose in a user's bodily fluids. Specifically, the device for detecting glucose in a user's bodily fluids may be a continuous glucose monitoring system. Other embodiments of the medical device are also possible.

[0025] As described above, the medical device has at least one invasive portion. As used herein, the term "invasive portion" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any part or component of an element constructed for at least partial percutaneous or subcutaneous implantation, insertion, and / or positioning in a user's body tissue. Insertion of the invasive portion of a medical device can be performed exemplarily by using an insertion device. Following insertion, the invasive portion of the medical device, or at least one component of the invasive portion, may remain in the user's body tissue for a predetermined period of time, such as several hours, specifically one day or more days, more specifically up to one week, or even more specifically up to two weeks or longer.

[0026] The invasive portion may be selected from the group consisting of: at least one analyte sensor for detecting at least one analyte in the user's bodily fluids; at least one insertion part; at least one infusion cannula; at least one stimulation electrode. Other embodiments may be feasible.

[0027] An analyte sensor may be configured for the qualitative and / or quantitative detection of at least one analyte. As used herein, the term "analyte" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, chemical and / or biological substances involved in the metabolism of a user's body. Specifically, an analyte may be a metabolite or a combination of two or more metabolites. As an example, an analyte may be selected from the group consisting of: glucose, lactate, triglycerides, and cholesterol. Other analytes or combinations of two or more analytes may still be detected. As used herein, the term "analyte sensor" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a sensor capable of qualitatively or quantitatively detecting the presence and / or concentration of at least one analyte. An analyte sensor may be an electrochemical analyte sensor. An analyte sensor may include at least two electrodes. Specifically, an analyte sensor may include at least one dual-electrode sensor. A dual-electrode sensor may precisely comprise two electrodes, such as a working electrode and at least one additional electrode, such as a relative electrode, particularly a working electrode and a combined relative / reference electrode. The working electrode may include a working electrode pad and optionally at least one test chemical disposed thereon. The relative electrode may include a relative electrode pad. Additionally and optionally, one or more redox materials may be disposed thereon. The analyte sensor may further include one or more leads for electrical contact electrodes. The leads may be connected to one or more electronic components during insertion or at a later point in time. Preferably, the leads may have already been connected to the electronic components before insertion of the analyte sensor. Further details regarding the electronic components are given below.

[0028] Specifically, the analyte sensor can be a needle-shaped or strip-shaped analyte sensor having a flexible substrate and electrodes disposed thereon. As an example, the analyte sensor may have an overall length of 5 mm to 50 mm, specifically 7 mm to 30 mm. The term "overall length" in the context of this invention refers to the overall length of the analyte sensor, meaning both the portion inserted into the analyte sensor and the portion that may remain outside the body tissue. The analyte sensor may be partially inserted into the user's body tissue. The portion inserted into the analyte sensor is generally referred to as the in vivo portion, and the portion that may remain outside the body tissue is generally referred to as the in vitro portion. Preferably, the in vivo portion has a length in the range of 3 mm to 12 mm. The analyte sensor may further include a biocompatible covering, such as a biocompatible membrane, which completely or partially covers the analyte sensor and prevents the test chemical from migrating into the body tissue and allows bodily fluids and / or analytes to diffuse to the electrodes. Other embodiments of the electrochemical analyte sensor, such as a three-electrode sensor, may be feasible. For example, in addition to a working electrode and a counter electrode, a three-electrode sensor may also include a reference electrode.

[0029] As used herein, the term "insertion component" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, any element that can be at least partially inserted into body tissue, particularly for the delivery or transfer of additional elements. The insertion component can specifically be configured to support the insertion of an analyte sensor. In the case of a medical device for detecting at least one analyte in a user's bodily fluids, the medical device may include an analyte sensor and an insertion component. The analyte sensor may remain in the user's body tissue for a predetermined period of time, and the insertion component may optionally be removed from the body tissue after insertion of the analyte sensor. However, alternatively, other embodiments are also possible, wherein the analyte sensor and the insertion component may remain in the user's body tissue for a predetermined period of time. The insertion component may include a tip or point for inserting the analyte sensor into the body tissue.

[0030] Insertion components for inserting analyte sensors into a user's body tissue may be or may include insertion cannulas or insertion needles. As used herein, the term "insertion cannulas" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a hollow needle that may be at least partially slotted. The analyte sensor may be received within the insertion cannulas, such as within the lumen of the insertion cannulas. As used herein, the term "insertion needle" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, a compact needle, particularly one without slots and without any hollow portion. The analyte sensor may be received on the outer surface of the insertion needle.

[0031] As used herein, the term "infusion cannula" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a hollow tube configured for the delivery and / or infusion of drugs into a user's body tissues, particularly the delivery and / or infusion of insulin into a user's body tissues.

[0032] As outlined above, a medical device includes at least one housing. As used herein, the term "housing" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any element constructed to completely or partially enclose and protect at least one internal space, such as mechanical protection and protection against one or more environmental influences, such as moisture, oxygen, and microbial contamination. Other types of protection may also be feasible. The housing may specifically be or may include a rigid housing, such as a rigid housing made of one or more plastic materials. The housing may specifically include at least one wall for completely or partially surrounding the internal space. The housing may also provide a base for attaching and / or securing one or more additional components or elements. The housing may be formed by two or more components of the medical device. The two or more components may at least partially, preferably completely, surround the enclosed chamber.

[0033] As described above, the housing at least partially surrounds at least one enclosed chamber. As used herein, the term "chamber" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, any portion or completely enclosed space that can be used to contain and / or store objects. The housing may include one or more chambers, such as at least two chambers. The at least two chambers may be separate chambers. One, more, or all of the at least two chambers may be enclosed chambers. The chamber may be formed by compartments within the housing. As used herein, the term "compartment" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, any sub-section of a higher-level element that creates a partially or completely enclosed space that can be used to contain and / or store objects. Specifically, the sub-section may be completely or at least substantially enclosed, such that the interior of the compartment is isolated from the surrounding environment. Exemplarily, the compartment may be separated from other portions of the higher-level element by one or more walls. Therefore, the housing may include two or more compartments, which may be completely or partially separated from each other by one or more walls of the housing. Each compartment may include a continuous space or cavity configured to accommodate one or more objects.

[0034] As used herein, the term "sealed chamber" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term can refer to, but is not limited to, a chamber that is isolated from its surrounding environment, thereby completely or at least substantially reducing the transfer of gaseous, fluid, and / or solid elements. A sealed chamber may also be called a sealed chamber. Specifically, a sealed chamber can be an airtight sealed chamber. As used herein, the term "airtight sealed chamber" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term can refer to, but is not limited to, any chamber that is sealed or enclosed in a manner that completely prevents the transfer of gas or fluid between the chamber's interior and its surrounding environment.

[0035] Specifically, a sealed room can be a sterile room. The term "sterile" generally refers to the property of any object or space being at least substantially free of all forms of life and / or other biological agents (such as prions, viruses, fungi, bacteria, or spores). Therefore, a sterile object or space can be treated by eliminating various forms of life and / or other biological agents and / or inactivating them through at least one sterile process. A sterile process may include one or more of the following techniques: heating, chemical treatment, irradiation, and autoclaving. However, other techniques may also be feasible.

[0036] As used herein, the term "at least partially enclosed" (also known as "at least partially closed") is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term may specifically refer to, but is not limited to, embodiments in which an object completely surrounds one or more additional components, and embodiments in which an object surrounds at least a portion of one or more additional components. As described above, the housing of a medical device at least partially surrounds a sealed chamber. In the case where the housing of the medical device completely surrounds the sealed chamber, the sealed chamber may be completely surrounded by at least one wall of the housing. However, in the case where the housing of the medical device partially surrounds the sealed chamber, the airtightness of the sealed chamber may be further accommodated by other components of the medical device.

[0037] As described above, the sealed chamber is constructed to maintain a pressure difference between at least one cavity of the sealed chamber and the surrounding environment. Due to the airtightness of the sealed chamber, gas transfer between the cavity of the sealed chamber and the surrounding environment can be prevented at least to a large extent, and a pressure difference between at least one cavity of the sealed chamber and the surrounding environment can be maintained. Conversely, in the case of a leaking chamber, gas transfer may occur between the cavity of the chamber and the surrounding environment, and the pressure difference between at least one cavity of the sealed chamber and the surrounding environment may not be maintained.

[0038] The invasive portion can be at least partially received within a sealed chamber. Specifically, the sealed chamber can be an airtight, sterile chamber. Therefore, the housing can be a housing for receiving the invasive portion of the medical device. The housing can be at least partially formed of at least one sterile cap. More details regarding the sterile cap are given below.

[0039] The medical device may include at least one invasive portion compartment. The invasive portion of the medical device may be at least partially received within the invasive portion compartment. The medical device may include at least one sterile cap, specifically at least one removable sterile cap, which at least partially surrounds at least a portion of the invasive portion of the medical device. The sterile cap may at least partially surround the invasive portion compartment. Specifically, the sterile cap may at least partially surround a sealed compartment. The sealed compartment may be surrounded by the invasive portion compartment.

[0040] As used herein, the term "lid" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, elements of any shape constructed to completely or partially enclose one or more objects and to provide protection to those objects, such as against mechanical influences and / or humidity. As used herein, the term "sterile lid" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, elements such as lids constructed to maintain a sterile atmosphere within a space completely or partially enclosed by the element. Furthermore, by way of example, a sterile lid may be a rigid sterile lid, for example, made of rigid plastic materials and / or metal.

[0041] Sterile lids can be substantially rotationally symmetric, for example, by having axial rotational symmetry about an axis, such as a cylindrical axis or an extended axis. As used herein, the term "substantially rotationally symmetric" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term may specifically refer to, but is not limited to, the fact that a sterile lid can be perfectly rotationally symmetric or may include at least one rotationally symmetric portion, while other portions of the sterile lid may exhibit a form deviating from rotational symmetry. Sterile lids can be designed as cylinders, hemispheres, or domes. The lid may have a shape adapted to the shape of the invasive portion of a medical device.

[0042] As an example, the sterile cap may have an elongated shape, with its length exceeding its diameter or equivalent diameter by at least two times, more preferably at least five times. As an example, the sterile cap may have a length of 5 to 20 mm, for example, 10 to 15 mm. Further, as an example, the sterile cap may have a diameter of 2 mm to 8 mm, preferably 4 mm to 7 mm, and most preferably 5 mm to 6 mm. Exemplarily, the sterile cap may have a length of 13 mm and a diameter of 5.5 mm. However, other sizes may also be feasible.

[0043] The term "removable" can refer to the property of a component that can be removed from any object. Thus, the tight connection or contact between the component and the object can be broken. Generally, the component can be removed in a reversible manner, where it can be attached to and detached from the object, or irreversibly, where it cannot be attached to the object after detachment. By removing the sterile cap, the invasive portion of the medical device can be exposed, and the medical device can be applied by the user or patient.

[0044] As described above, the insertion component may specifically include at least one insertion cannula. The insertion cannula may be fully or partially received within a sterile cap. As an example, the sterile cap may have an elongated shape with a closed end and an open end, the insertion cannula projecting from the open end into the sterile cap with its tip facing the closed end. The analyte sensor may be partially received within the insertion cannula, such as within a groove of the insertion cannula. The insertion component may further include at least one retainer for the insertion cannula, wherein the retainer, the insertion cannula, and the sterile cap form components of a sterile container for the analyte sensor. As an example, the retainer may include a rigid component connected to the proximal end of the insertion cannula, i.e., to the end of the insertion cannula opposite the tip of the insertion cannula. As an example, the insertion cannula may be attached to the retainer by gluing and / or by injection molding and / or, for example, by other material bonding means. As an example, the retainer may have a cylindrical shape.

[0045] Specifically, in the case where the medical device is a device for detecting at least one analyte in a user's bodily fluids, the invasive portion may include an analyte sensor and an insertion member. The medical device may further include at least one retainer for the insertion member. The retainer and sterile cap for the insertion member may at least partially surround the sealed chamber. The housing of the medical device may be formed from the retainer and sterile cap for the insertion member. Thus, the retainer and sterile cap for the insertion member can form a sterile container for the analyte sensor and for the insertion member. However, other components of the housing may also contribute to surrounding and / or forming the sealed chamber.

[0046] Specifically, in the case where the medical device is a pharmaceutical device for delivering at least one therapeutic medical fluid to a user, the invasive portion may include an infusion cannula. The medical device may further include at least one retainer for the infusion cannula. The sealed chamber may be at least partially surrounded by a sterile cap and the retainer for the infusion cannula. The housing of the medical device may be formed from the retainer for the infusion cannula and the sterile cap. Thus, the retainer for the infusion cannula and the sterile cap can form a sterile container for the infusion cannula. However, other components of the housing may also contribute to surrounding and / or forming the sealed chamber.

[0047] The medical device may further include at least one patch configured for attachment to a user's skin. Specifically, the patch may include a plate that can serve as a support for other components of the medical device, such as electronic components. Further, the patch may be configured to attach components of the medical device to a user's skin site. For this purpose, the patch may include at least one adhesive surface and / or at least one adhesive strip or strap. The patch may include at least one patch base. The retainer, sterile cap, and patch base of the insertion component or infusion cannula may at least partially surround a sealed chamber. The housing of the medical device may be formed from the retainer, sterile cap, and patch base for the infusion cannula or insertion component. Other embodiments are also possible.

[0048] The medical device may further include at least one electronic unit. The electronic unit may include at least one electronic component. The electronic unit may further include at least one electronic unit housing. The electronic component may be housed within the electronic unit housing. The medical device may include at least one electronic component compartment. The electronic component of the medical device may be at least partially housed within the electronic component compartment. The sealed compartment may be surrounded by the electronic unit housing. The housing may be an electronic unit housing.

[0049] As used herein, the term "electronic unit" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to any particular or customary meaning. Specifically, the term may refer to, but is not limited to, any unit, such as a unit that can be held in a monolithic form, configured to perform at least one electronic function. Specifically, in the case of a medical device for detecting analytes in a user's bodily fluids, the electronic unit may have at least one interface for connecting to an analyte sensor, wherein the electronic unit provides at least one electronic function that interacts with the analyte sensor, such as at least one measurement function.

[0050] As an alternative to embodiments with an electronic component compartment, the electronic unit may include or may be a plug-in connector or electrical connection. Therefore, the electronic unit may include electrical and / or mechanical interfaces. Consequently, there may not be any additional compartments besides the intrusive partial compartment.

[0051] Specifically, if the medical device is for detecting analytes in a user's bodily fluids, the electronic unit can be configured to: determine and / or control the detection of the analyte, and / or transmit measurement data to another component. Specifically, the electronic component can be configured to: perform measurements using an analyte sensor, perform voltage measurements, perform current measurements, record sensor signals, store measurement signals and / or measurement data, and transmit sensor signals to another component. Therefore, the electronic unit can specifically include at least one of the following: a voltmeter, an ammeter, a potentiostat, a voltage source, a current source, a signal receiver, a signal transmitter, an analog-to-digital converter, an electronic filter, a data storage device, and an energy storage device.

[0052] The analyte sensor may be partially enclosed by an electronics housing. Specifically, the electronics housing may include at least one analyte sensor, such as having a proximal end, which may protrude into the analyte housing and be electrically connected to at least one electronic component within the analyte housing. As an example, the proximal end and / or at least one contact portion of the analyte sensor may protrude into the analyte housing and be electrically connected thereto to at least one electronic component, such as to at least one printed circuit board and / or at least one contact portion of the analyte housing, for example, via one or more of soldering, pressure bonding, plugging, clamping, etc. Specifically, the electronics housing may function as a transmitter for wirelessly transmitting measurement data, for example, to at least one external device, such as to at least one receiver.

[0053] The electronic unit housing can be a sealed housing. The electronic unit housing does not usually need to meet the requirements of sterility and airtightness, but it must usually be waterproof and dustproof.

[0054] Specifically, when the medical device is a pharmaceutical device for delivering at least one therapeutic medical fluid to a user, the medical device may include the following components:

[0055] At least one drug reservoir configured to store at least one therapeutic medical fluid;

[0056] At least one infusion cannula, such as those described above or described in further detail below; and

[0057] At least one drug pump configured to deliver therapeutic medical fluid from a drug reservoir to an infusion cannula.

[0058] Specifically, when the medical device is a device for detecting at least one analyte in a user's bodily fluids, the medical device may include the following components:

[0059] At least one analyte sensor, such as those described above or described in further detail below;

[0060] At least one electronic unit, such as those described above or described in further detail below, wherein the electronic unit is electrically connected to the analyte sensor; and

[0061] At least one insertable component, such as those described above or described in further detail below, wherein the insertable component is configured to insert an analyte sensor into a user’s body tissue.

[0062] Specifically, the medical device may include at least two housings. Specifically, the medical device may have at least one first housing having at least one first sealed chamber. Specifically, a sterile lid may at least partially surround the first sealed chamber. Therefore, the first housing may include a sterile lid. Further, the medical device may specifically have at least one second housing having at least one second sealed chamber. The second housing may be an electronic unit housing, and electronic components may be received within the second sealed chamber. The medical device may include at least one first deformable member and at least one second deformable member. The wall of the sterile lid may include the first deformable member. The wall of the electronic unit housing may include the second deformable member.

[0063] As described above, the medical device may include an invasive portion compartment and an electronic component compartment. The invasive portion compartment and the electronic component compartment may be two separate compartments. The interior of the invasive portion compartment may be isolated from the interior of the electronic component compartment. The invasive portion compartment and the electronic component compartment may be separated from each other by one or more walls of the medical device. However, optionally, the invasive portion compartment and the electronic component compartment may share at least one common wall. The invasive portion may be at least partially received in the invasive portion compartment. However, a portion of the invasive portion may be received in the electronic component compartment. The invasive portion compartment may include at least one sealed opening, such as for leading a portion of the invasive portion (e.g., an analyte sensor) out of the invasive portion compartment for operative connection to at least one electronic component received in the invasive portion compartment.

[0064] As used herein, the term "deformable component" is a broad term and should be given its common and conventional meaning by those skilled in the art, not limited to a specific or customized meaning. Specifically, the term can refer to, but is not limited to, any component whose shape can be changed by external forces or mechanical stress. Deformation can specifically be described as a change in length, i.e., elongation. Deformation can refer to reversible elastic deformation or irreversible plastic deformation. Reversibly elastic deformable materials can change their shape when a force is applied and can return to their original shape when the applied force is removed. Irreversible plastic deformation may occur when the elastic limit of the material is reached. A prerequisite for such materials is that they are formable and can absorb deformation energy. The related property of such materials is also called ductility. Specifically, deformable components can be deformed under pressure.

[0065] The integrity of the casing can be monitored by applying negative or positive pressure. Negative pressure can naturally be limited to a pressure difference of up to approximately 100,000 Pa. For example, the integrity of the casing can be monitored under a pressure difference greater than 80,000 Pa (i.e., 20,000 Pa absolute pressure).

[0066] Monitoring the integrity of the housing can be performed by applying positive pressure. Therefore, in principle, any pressure can be applied. However, the applied pressure can be based on the operating pressure of the medical device and its mechanical properties. For example, monitoring the integrity of the housing can be performed under a pressure difference of 100,000 Pa to 400,000 Pa (i.e., 500,000 Pa absolute pressure). At a relative test pressure of 400,000 Pa, deformation of a medical device without deformable parts can be expected to be in the range of 10 nm to 100 nm. Such deformation may be too small to be tested in a production environment using conventional measurement methods.

[0067] The deformable component may have a flat shape. The deformable component may have a large area range relative to its thickness. Exemplarily, the length and / or width of the deformable component may exceed its thickness by at least 2 times, preferably at least 10 times, and most preferably at least 20 times. However, other dimensions may also be feasible.

[0068] The deformable component may, by way of example, have a thickness of 0.05 mm to 2.0 mm, preferably 0.1 mm to 1.0 mm, and most preferably 0.3 mm. Further, the deformable component may have a length of 1 mm to 5 mm, preferably 2 mm to 4 mm, and more preferably 3 mm. Further, the deformable component may have a width of 1 mm to 5 mm, preferably 2 mm to 4 mm, and more preferably 3 mm. By way of example, the deformable component may have a thickness of 0.3 mm, a length of 3 mm, and a width of 3 mm. However, other dimensions may also be feasible.

[0069] The sterile cap, specifically the wall of the sterile cap, may exemplary have a thickness of 0.2 mm to 5 mm, preferably 0.5 mm to 3 mm. Specifically, the wall of the sterile cap may have a thickness of 0.5 mm to 3 mm, and the deformable component may have a thickness of 0.1 mm to 1.0 mm. However, other dimensions may also be feasible.

[0070] The electronic unit housing, specifically the walls of the electronic unit housing, can exemplary have a thickness of 0.08 mm to 5 mm, preferably 0.1 mm to 3 mm. Specifically, the walls of the sterile cap can have a thickness of 0.1 mm to 3 mm, and the deformable components can have a thickness of 0.1 mm to 1.0 mm. However, other dimensions may also be feasible.

[0071] The deformable component can have any shape. Exemplarily, the deformable component can have a basic circular shape, such as a circular basic shape, an elliptical basic shape, an oval shape, or a rectangular basic shape, specifically a rectangular basic shape with rounded corners. However, other embodiments may also be possible.

[0072] Deformable components can be made, by way of example, of at least one material selected from the group consisting of: acrylonitrile butadiene styrene (ABS), polypropylene, polystyrene, polyamide, polycarbonate, polyethylene, polymethyl methacrylate (PMMA), polyoxymethylene (POM), thermoplastic elastomer (TPE), and polysiloxane. However, other materials are also feasible.

[0073] For example, the deformable component may include at least one material having a tensile strength of 40 MPa to 180 MPa.

[0074] The housing, specifically the electronic unit housing and / or sterile cap, can be exemplary, at least in part, made of polycarbonate. However, other materials may also be feasible.

[0075] Deformable components may have predefined material strength and / or predefined thickness. The term "predefined" specifically refers to the situation where the material strength and / or thickness are defined prior to monitoring the integrity of the medical device's housing. Therefore, the material strength and / or thickness are predetermined and known prior to monitoring the integrity of the medical device's housing. Exemplarily, the material strength can be adjusted, for example, by selecting the material, and / or the thickness can be adjusted, for example, by selecting the design of the deformable component. The term "material strength" can generally refer to a material property describing the mechanical resistance provided by the material to plastic deformation or separation. Material strength can be determined from a stress-strain diagram. Different strengths can be achieved depending on the selection of the material, material condition, temperature, load, and loading rate.

[0076] At least one wall of the housing, specifically the outer wall of the housing, may include a deformable member. The housing, specifically the wall of the housing, specifically the outer wall of the housing, may include at least one recess, such as at least one cutout. The deformable member may be located in or received within the recess or cutout. The recess may also be referred to as a window of the housing, specifically a window of the wall of the housing. The deformable member may form part of the wall of the housing. The remaining portion of the wall of the housing may at least partially, preferably completely, surround the deformable member.

[0077] The housing and deformable components can be designed integrally. The term "integrally" can refer to a state in which two or more components are arranged in a space-saving or compact manner. At least one of the two or more components can be permanently constructed into at least one of the two or more components. Furthermore, the two or more components can be designed in a complementary manner, such that the components may be able to interact with each other. Exemplarily, the walls of the housing and the deformable components can be formed as a single piece.

[0078] Specifically, the housing and the deformable component can be manufactured as a single piece. In this case, the deformable element can be distinguished solely by its offset, functionally oriented profile. Specifically, the housing and the deformable component can be manufactured via injection molding. The housing and the deformable component can be characterized by their specific geometries. For example, the housing may have walls thicker than the walls of the deformable component.

[0079] A shell and a deformable part are manufactured as a single piece but made of different materials using two-component injection molding. Thus, each of the shell and the deformable part can be made of a material suitable for its specific function. For example, the shell can be made of at least one solid material, and the deformable part can be made of at least one elastic material. A seal between the shell and the deformable part can be achieved by melting these two materials during injection molding.

[0080] The deformable component can be sealed against the remaining wall of the housing. Thus, a sealed chamber can be formed. Exemplarily, an adhesive bond, such as via a cured adhesive, can exist between the housing and the deformable component. Furthermore, ultrasonic or laser welding of the joint can also be used. Other methods may also be feasible.

[0081] Specifically, as described above, the intrusion portion can be at least partially received within a sealed chamber, and the shell can be at least partially formed of at least one sterile cap. The sterile cap may include a deformable component. The deformable component may form part of the wall of the sterile cap, specifically part of the outer wall. Specifically, the deformable component may form part of the wall of the sterile cap, specifically part of the outer wall, about an axis of rotation of the sterile cap.

[0082] Furthermore, additionally or alternatively, the housing can be an electronic unit housing and the electronic components can be housed within a sealed chamber. Deformable components can form part of the wall of the electronic unit housing, specifically part of the outer wall.

[0083] As described above, the housing is constructed such that the deformation state of the deformable component provides a measurable indication of the pressure difference between the interior of the sealed chamber and the surrounding environment. When the medical device is placed in the test chamber and a test pressure is applied to the test chamber, the deformable component can change its shape due to the applied test pressure. The test pressure can be greater than or less than the ambient pressure. Depending on the test pressure and in the case of a sealed chamber, the deformable component can rotate inwards or outwards, i.e., toward the surrounding environment. The rotation of the deformable component inwards or outwards is referred to as the deformation of the deformable component. The deformation state can change over time. Therefore, to assess the integrity of the medical device housing, the deformation state can be detected over time. Therefore, the deformation of the deformable component can depend on the pressure difference between the interior of the sealed chamber and the surrounding environment. Therefore, when the deformation state of the deformable component is detected, the pressure difference between the interior of the sealed chamber and the surrounding environment can be determined. Depending on the test pressure and in the event of chamber leakage, the deformable component may not deform due to pressure compensation between the interior and the surrounding environment.

[0084] The medical device may further include at least one integrated deformation sensor configured to measure the deformation state of a deformable component. As used herein, the term "sensor" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any element or device configured to detect at least one state or to measure at least one measurement variable. As used herein, the term "deformation sensor" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any element or device configured to detect at least one deformation or displacement of any object. Specifically, a deformation sensor may be configured to detect a protrusion of an object. As used herein, the term "integrated sensor" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any sensor configured to be preferably fixedly attached to or mounted on any test sample. Therefore, an integrated deformation sensor may also be referred to as an airborne deformation sensor. Specifically, the integrated deformable sensor can be attached to the surface of the deformable component sensor and / or the surface of the housing, specifically to the surface of the sterile cap or the surface of the electronic unit housing. Specifically, the integrated deformable sensor can completely or partially cover the surface of the deformable component. The surface of the deformable component can specifically be the outer surface facing the external environment.

[0085] The integrated deformation sensor may include at least one extended sensitive color layer. The extended sensitive color layer may be configured to change color according to the deformation of the deformable component. A first color may indicate that the airtightness of the sealed chamber is intact. A second color, which may be different from the first color, may indicate that the airtightness of the sealed chamber is defective. The color change of the extended sensitive color layer can be seen visually by a user or inspector. Therefore, applying at least one extended sensitive color layer can be an embodiment that eliminates the need for electronic assessment of the airtightness of the sealed chamber.

[0086] Furthermore, additionally or alternatively, the integrated deformation sensor may be selected from the group consisting of: strain gauges; switch contacts; optical distance measurement sensors, such as reflection measurement sensors or angle measurement sensors; and capacitive sensors. However, other methods may also be feasible, such as triangulation methods or thin-film resistance measurements.

[0087] As a particular embodiment, the deformable component can be or may include a foil with special optical properties. Using a suitable foil, a low-cost optical sensor can detect the curvature of the foil by means of the reflection angle.

[0088] An integrated deformation sensor may include at least one transmitter for transmitting measured values ​​to at least one external receiver.

[0089] Specifically, the medical device may have at least one movable part. The movable part may be a lid for a sealed chamber within a closed housing. The medical device, specifically the movable part itself, may include at least one sealing element. The sealing element may be made of at least one elastomeric material. The sealing element may be configured to seal the movable part against the sealed chamber. The movable part may be detachably connected to the housing. The movable part and the housing may form a multi-part design. The movable part may be detachably inserted into and engaged with the housing by means of the sealing element. The elastic properties of the sealing element may allow the movable part to move relative to the housing. Due to an applied relative pressure difference, the movable part may withstand a force corresponding to the pressure difference and may move within the elastic displacement of the sealing element.

[0090] Exemplarily, the movable component may be a lid that closes the intrusion compartment. Exemplarily, a sterile lid may form a removable lower lid for the intrusion compartment, and the movable component may form a removable upper lid for the intrusion compartment. An electronic unit housing may form an intermediate component of the medical device, disposed between the sterile lid and the movable component. The sterile lid and the movable component may be located on opposite sides of the electronic unit housing. A sealing element may be disposed within the electronic unit housing. Alternatively, the sealing element may be part of the movable component. The sealing element may be configured to seal the movable component against the electronic unit housing. The movable component may be detachably connected to the electronic unit housing. The movable component and the electronic unit housing may form a multi-component design. The movable component may be detachably inserted into and engaged with the electronic unit housing by means of the sealing element. The elastic properties of the sealing element may allow the movable component to move relative to the electronic unit housing. Due to the applied relative pressure difference, the movable component may withstand a force corresponding to the pressure difference and may move within the elastic displacement of the sealing element.

[0091] In a further aspect of the invention, a kit is disclosed.

[0092] As used herein, the term "kit" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, a group of at least two components that can interact with each other to achieve at least one common function. The at least two components may be processed independently or combined, connected, or integrated to form a common device.

[0093] The kit includes medical devices as described above or as further described in more detail below. Therefore, for possible definitions and options, reference can be made to this disclosure of medical devices according to the invention.

[0094] Furthermore, the kit includes at least one external deformation sensor configured to measure the deformation state of the deformable component. As used herein, the term "external sensor" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, any sensor configured to be provided separately from the test sample. Specifically, the external sensor may be positioned at a distance from the test sample. The external deformation sensor may specifically be a displacement sensor. The displacement sensor may be configured to measure changes in distance or length between the object and a reference point. The displacement sensor may be exemplary selected from the group consisting of: inductive sensors; incremental encoders; and laser rangefinders. However, other embodiments may also be feasible.

[0095] The medical kit may further include at least one integrity assessment unit configured to export at least one piece of integrity information from a deformed state. As used herein, the term "assessment unit" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any functional element configured for analyzing and / or processing data. The assessment unit may specifically analyze and / or process measurement data, such as measurement results generated by a measurement unit. The assessment unit may particularly include at least one processor. The processor may be specifically configured, such as through software programming, to perform one or more assessment operations on the measurement results.

[0096] As used herein, the term "integrity" is a broad term and is given its common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, the properties of an object that satisfy one or more integrity criteria. Specifically, integrity criteria may refer to predefined properties of an object. More specifically, integrity criteria may refer to the leak-proofness of an object. Specifically, an object may have at least one internal cavity surrounded by one or more walls.

[0097] The kit may further include at least one test chamber. As used herein, the term "test chamber" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a particular or customary meaning. The term may specifically refer to, but is not limited to, any portion or completely enclosed space that can be pressurized with a defined pressure. The defined pressure may also be referred to as the test pressure. The test pressure may be greater than or less than the ambient pressure. The test chamber may be a sealed chamber. The test chamber and the sealed chamber surrounded by the housing of the medical device may be separate chambers. The medical device may be completely housed within the test chamber. The test chamber may not be part of the medical device.

[0098] In another aspect of the invention, a method for monitoring the integrity of the housing of a medical device is disclosed.

[0099] As used herein, the term "monitoring" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, detecting at least one property of an object and detecting changes in that at least one property of the object over time. As an example, the at least one property may be a physical property. As used herein, the term "method for monitoring the integrity of a housing" is a broad term and is given its common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any process in which at least one property of a housing that meets one or more integrity criteria is monitored. Thus, the term may specifically refer to monitoring at least one predefined property of a housing, and more specifically, monitoring the leak-proofness of the housing. The structural stability and performance of the housing may be monitored. Integrity monitoring may specifically be performed at the manufacturer's end. Integrity monitoring may specifically be performed by the manufacturer as part of product development and / or manufacturing quality control. It can ensure that the housing functions according to the manufacturer's sterility statement and that there are no leaks or defects in the housing.

[0100] The method includes the following disclosed steps. These steps may be performed in a given order. However, a different order is also possible. The method may include additional steps not mentioned. Furthermore, one or more method steps may be performed repeatedly. Further, two or more method steps may be performed in a time-overlapping or parallel manner.

[0101] The method includes the following steps:

[0102] a) Provide a medical device as described above or as further described in more detail below;

[0103] b) Place the medical device in the test chamber and apply test pressure to the test chamber;

[0104] c) Detect the deformation state of the deformable component, preferably over time; and

[0105] d) Assess the integrity of the medical device housing based on the deformation state of deformable components.

[0106] Therefore, for possible definitions and options of medical devices, reference can be made to the disclosure of medical devices as described in this invention.

[0107] The test pressure can be greater than or less than the ambient pressure.

[0108] The test chamber may include at least one external deformation sensor configured to measure the deformation state of the deformable component. For further details regarding the external deformation sensor, please refer to the description above. The tare weight of the external deformation sensor may be determined under normal pressure before proceeding to step c).

[0109] Alternatively or concurrently, the medical device may further include at least one integrated deformation sensor. For more details regarding the integrated deformation sensor, please refer to the description above. In step c), the integrated deformation sensor can detect the deformation state of the deformable component.

[0110] In a sealed chamber, deformable components may undergo deformation. In a defective sealed chamber, and thus a leaking chamber, the same pressure is generated within the chamber due to leakage. Due to pressure compensation, the deformable component does not deform. If the deflection of the deformable component is recorded over time—that is, a dynamic measurement—conclusions about the size of the leak can be drawn from the shape of the resulting curve showing the deflection over time.

[0111] Furthermore, when the test pressure is released, the deformable component can return to its initial position. The extent to which the deformable component returns to its original position allows conclusions to be drawn regarding the airtightness of the deformable component. This can be used as a further evaluation criterion. Undesirable measurements and artifacts generated by the deformable component can be easily mathematically compensated for by forming a ratio of displacement motion to the remaining reset position, compared to purely considering displacement. This means that relative methods can be used to evaluate absolute measurements.

[0112] Furthermore, the medical device may have at least one movable part. For further details, please refer to the description above. The method may further include detecting the movement of the movable element relative to its reset position and assessing the integrity of the housing.

[0113] This document further discloses and proposes a computer program comprising computer-executable instructions that, when executed on a computer or computer network, perform one or more of the methods according to the invention in the appended embodiments, specifically one or both of steps c) and d). Specifically, the computer program may be stored on a computer-readable data carrier and / or a computer-readable storage medium.

[0114] As used herein, the terms "computer-readable data carrier" and "computer-readable storage medium" can specifically refer to non-transitory data storage devices, such as hardware storage media having computer-executable instructions stored thereon. Computer-readable data carriers or storage media can specifically be or can include storage media such as random access memory (RAM) and / or read-only memory (ROM).

[0115] Therefore, specifically, one, more, or even all of the method steps c) and d) as indicated above can be performed by using a computer or computer network, preferably by using a computer program.

[0116] This document further discloses and proposes a computer program product having program code components so that, when executed on a computer or computer network, it performs one or more of the methods according to the invention in the appended embodiments, specifically one or all of method steps c) and d). Specifically, the program code tools may be stored on a computer-readable data carrier and / or a computer-readable storage medium.

[0117] This document further discloses and proposes a data carrier having a data structure stored thereon, which, after being loaded into a computer or computer network, such as into the working memory or main memory of the computer or computer network, can perform one or more of the methods according to the invention in the appended embodiments, specifically one or all of method steps c) and d).

[0118] This document further discloses and proposes a non-transitory computer-readable medium comprising instructions that, when executed by one or more processors, cause the one or more processors to perform one or more methods according to the embodiments disclosed herein, specifically one or more of method steps c) and d).

[0119] This document further discloses and proposes a computer program product having program code components stored on a machine-readable medium so that, when the program is executed on a computer or computer network, it performs one or more methods according to the embodiments disclosed herein, specifically one or all of method steps c) and d). As used herein, a computer program product refers to a program that is a tradable product. The product can generally exist in any format (such as in paper format) or reside on a computer-readable data carrier and / or a computer-readable storage medium. Specifically, the computer program product can be distributed on a data network.

[0120] Finally, this document discloses and proposes a modulated data signal containing instructions readable by a computer system or computer network for performing one or more methods according to the embodiments disclosed herein, specifically one or all of method steps c) and d).

[0121] Referring to the computer execution aspect of the present invention, one or more method steps in one or more of the methods disclosed in the embodiments herein, specifically one or even all of method steps c) and d), can be performed using a computer or computer network. Therefore, in general, any method step including providing and / or manipulating data can be performed using a computer or computer network. Generally, these method steps can include any method steps other than those typically requiring manual operation (such as providing samples and / or performing certain aspects of actual measurement).

[0122] Specifically, this article further discloses the following:

[0123] - A computer or computer network including at least one processor, wherein the processor is adapted to perform a method of an embodiment of the embodiments described in this specification, specifically one or more of method steps c) and d).

[0124] - A computer-loadable data structure adapted to perform a method of an embodiment of the embodiments described in this specification when the data structure is executed on a computer, specifically one or more of method steps c) and d).

[0125] - A computer program adapted to perform, when executed on a computer, a method of an embodiment described in this specification, specifically one or all of method steps c) and d).

[0126] - A computer program including program components for performing a method of an embodiment described in this specification when the computer program is executed on a computer or computer network, specifically one or all of method steps c) and d).

[0127] - A computer program, comprising program means according to the foregoing embodiments, wherein the program means are stored on a computer-readable storage medium.

[0128] - A storage medium wherein a data structure is stored on the storage medium and wherein the data structure is adapted to perform a method of an embodiment described herein after being loaded onto a computer or computer network, primarily and / or operating on the storage medium, specifically one or more of method steps c) and d), and

[0129] - A computer program product having program code components, wherein the program code components may be stored or stored on a storage medium to perform a method of an embodiment of the embodiments described in this specification when the program code components are executed on a computer or computer network, specifically one or even all of method steps c) and d).

[0130] Compared to known methods and apparatuses, the methods and apparatus according to the present invention offer numerous advantages. Typically, device airtightness measurements are used as indirect measurements to test device integrity. However, for complex devices comprising different chambers, such as continuous glucose monitoring devices, performing specific measurements via such methods is difficult. The present invention provides a method and medical apparatus for measuring device-specific integrity via wall deformation under pressure.

[0131] Currently, the device of the present invention, with its specific wall structure (such as a membrane-like functional area), enables integrity testing over time via a pressure chamber. This results in the selective measurement of the integrity of medical devices, such as sterility / sealing. This method can be applied, for example, to continuous glucose monitoring systems (CGM devices) or insulin delivery systems (IDS, insulin pumps).

[0132] Selective measurement of the integrity of medical devices, such as sterility / sealing, may also be feasible. Furthermore, 100% control over the device (such as process control or release control) can be achieved. Since indicators can be mounted on the medical device, release and process control testing can be simplified.

[0133] The integrity of the housing can provide indirect evidence. The analyte sensor can be placed within a sterile lid, which can be part of the product, such as a medical device. This means that part of the medical device's housing can form a hermetically sealed sterile chamber in which the analyte sensor is located. Adaptive designs for the medical device can be provided that enable site-selective leak testing. For this purpose, the hermetically sealed chamber can be designed to have a deformable outer wall at at least one point. Each additional volume of the medical device to be tested for leak tightness can also be equipped with a deformable outer wall. To test the chamber's tightness, the medical device can be placed in a closed test chamber under test pressure. This test pressure can be selected to be greater than or less than ambient pressure. A displacement measurement sensor can be used to scan the deformable outer wall of the medical device. In the case of a hermetically sealed chamber, the deformable outer wall may undergo deformation. In the case of a leaking medical device, due to leakage, the same pressure appears in the chamber to be tested (in this case, the chamber formed by the sterile lid or the chamber formed by the electronic unit housing) as in the volume of the test chamber. Due to pressure compensation, the deformable wall does not deform. If the wall deflection is recorded over time—that is, a dynamic measurement—conclusions about the leak size can be drawn from the shape of the "deflection over time" result curve. With this type of design for medical devices, the device itself can be used as a sensor for its own leaks. The "normal" body surface can be raised to a menu-faced state for testing. Therefore, specific material strengths, wall thicknesses, etc., can be specified by design, resulting in specific measurement effects. This test can be completed in a very short measurement time, which is beneficial for process control.

[0134] The deflection can also be measured using the medical device itself. For example, a strain gauge or other suitable sensor technology (switch contacts) can be inserted into the medical device itself. During testing, the medical device can use its own electronics to determine the deflection of the functional area and can wirelessly transmit the results to the testing system or user. In this way, for example, a statement regarding the sterility status of the medical device can be received.

[0135] Methods without electronic devices can also be thought of as "airborne" sensor systems. If the menu surface is coated with a strain-sensitive, irreversible layer of paint, the color of that layer can indicate to the inspector whether the menu surface has deflected. The indicator color, "red" or "green," can indicate whether aseptic protection is intact or defective.

[0136] In summary, and without excluding other possible embodiments, the following embodiments are conceivable:

[0137] Example 1: A medical device having at least one invasive portion, the medical device comprising at least one housing at least partially surrounding at least one sealed chamber configured to maintain a pressure difference between at least one interior cavity of the sealed chamber and the surrounding environment, wherein the housing includes at least one deformable member, wherein the housing is configured such that the deformation state of the deformable member provides a measurable indication of the pressure difference between the interior cavity of the sealed chamber and the surrounding environment.

[0138] Example 2: The medical device according to the foregoing embodiments, wherein the medical device further includes at least one integrated deformation sensor configured to measure the deformation state of a deformable component.

[0139] Example 3: The medical device according to the foregoing embodiments, wherein the integrated deformation sensor includes at least one extended sensitive color layer, wherein the extended sensitive color layer is configured to change color according to the deformation of the deformable component.

[0140] Example 4: A medical device according to any one of the preceding two examples, wherein the integrated deformation sensor is selected from the group consisting of: strain gauges; switch contacts; optical distance measurement sensors, such as reflection measurement sensors or angle measurement sensors; capacitive sensors.

[0141] Example 5: A medical device according to any one of the preceding three examples, wherein the integrated deformable sensor includes at least one transmitter for transmitting a measurement value to at least one external receiver.

[0142] Example 6: A medical device according to any one of the preceding four examples, wherein an integrated deformable sensor is attached to the surface of the deformable component sensor and / or to the surface of the housing.

[0143] Example 7: The medical device according to the foregoing embodiments, wherein an integrated deformation sensor completely or partially covers the surface of the deformable component.

[0144] Example 8: A medical device according to any one of the foregoing embodiments, wherein the wall of the housing includes a deformable component.

[0145] Example 9: The medical device according to this embodiment, wherein the wall of the housing includes at least one recess, wherein a deformable component is received in the recess.

[0146] Example 10: A medical device according to any of the preceding embodiments, wherein the deformable component forms at least partially around a portion of the housing of the sealed chamber.

[0147] Example 11: A medical device according to any of the preceding embodiments, wherein the deformable component has a predefined material strength and / or a predefined thickness.

[0148] Example 12: A medical device according to any one of the foregoing embodiments, wherein the deformable component comprises at least one material having a tensile strength of 40 MPa to 180 MPa.

[0149] Example 13: A medical device according to any one of the foregoing embodiments, wherein the deformable component has a thickness of 0.1 mm to 1.0 mm.

[0150] Example 14: A medical device according to any one of the preceding embodiments, wherein the deformable component is made of at least one material selected from the group consisting of: acrylonitrile butadiene styrene (ABS), polypropylene, polystyrene, polyamide, polycarbonate, polyethylene, polymethyl methacrylate (PMMA), polyoxymethylene (POM), thermoplastic elastomer (TPE), and polysiloxane.

[0151] Example 15: A medical device according to any one of the preceding examples, wherein the housing is at least partially made of polycarbonate.

[0152] Example 16: A medical device according to any one of the preceding embodiments, wherein the housing and deformable components are designed integrally.

[0153] Example 17: A medical device according to any one of the preceding embodiments, wherein the invasive portion is selected from the group consisting of: at least one analyte sensor for detecting at least one analyte in a user's bodily fluids; at least one insertion part; at least one infusion cannula; at least one stimulation electrode.

[0154] Example 18: The medical device according to the foregoing embodiments, wherein the insertion component is selected from the group consisting of: an insertion needle; an insertion cannula.

[0155] Example 19: A medical device according to any one of the preceding embodiments, wherein the invasive portion is at least partially received in a sealed chamber.

[0156] Example 20: A medical device according to any of the preceding embodiments, wherein the medical device includes at least one sterile cap that at least partially surrounds the invasive portion.

[0157] Example 21: A medical device according to the foregoing embodiments, wherein the medical device further includes at least one retainer for inserting a component, wherein the retainer and a sterile cap at least partially surround a sealed chamber.

[0158] Example 22: A medical device according to the foregoing embodiments, wherein the medical device further includes at least one patch configured to be applied to a user's skin, wherein the patch includes at least one patch base, wherein the retainer, sterile cap and patch base at least partially surround a sealed chamber.

[0159] Example 23: A medical device according to any one of the preceding three embodiments, wherein the deformable component forms part of the wall of a sterile cap.

[0160] Example 24: A medical device according to any one of the foregoing embodiments, wherein the medical device further includes at least one electronic unit, wherein the electronic unit includes at least one electronic component, wherein the electronic unit further includes at least one electronic unit housing, wherein the electronic component is received in the electronic unit housing.

[0161] Example 25: The medical device according to the foregoing embodiments, wherein the electronic unit housing is a sealed housing.

[0162] Example 26: A medical device according to any one of the preceding two examples, wherein the housing is an electronic unit housing, and the electronic components are housed in a sealed chamber.

[0163] Example 27: A medical device according to any one of the preceding three embodiments, wherein the deformable component forms part of the wall of the electronic unit housing.

[0164] Example 28: A medical device according to any one of the foregoing embodiments, wherein the medical device is selected from the group consisting of: a pharmaceutical device for delivering at least one therapeutic medical fluid to a user, specifically a device for delivering insulin to a user; and a device for detecting at least one analyte in the user's bodily fluids, specifically a device for detecting glucose in the user's bodily fluids.

[0165] Example 29: A kit comprising a medical device according to any one of the foregoing embodiments and at least one external deformation sensor configured to measure the deformation state of a deformable component.

[0166] Example 30: The kit according to the foregoing embodiments, wherein the kit further includes at least one integrity assessment unit configured to export at least one piece of integrity information from the deformed state.

[0167] Example 31: The kit according to any one of the preceding two examples, wherein the external deformation sensor is a displacement sensor, wherein the displacement sensor is selected from the group consisting of: inductive sensor; incremental encoder; laser rangefinder.

[0168] Example 32: A method for monitoring the integrity of a medical device housing, the method comprising:

[0169] a) Provide a medical device according to any one of the foregoing embodiments relating to a medical device;

[0170] b) Place the medical device in the test chamber and apply test pressure to the test chamber;

[0171] c) Detect the deformation state of the deformable component, preferably over time; and

[0172] d) Assess the integrity of the medical device housing based on the deformation state of deformable components.

[0173] Example 33: The method described in the foregoing examples, wherein the test pressure is greater than or less than the ambient pressure.

[0174] Example 34: The method according to any one of the preceding two examples, wherein the test chamber includes at least one external deformation sensor configured to measure the deformation state of the deformable component.

[0175] Example 35: According to the method described in the foregoing examples, the tare weight of the external deformation sensor is measured under normal pressure before step c).

[0176] Example 36: According to any one of the preceding four examples, the medical device further includes at least one integrated deformation sensor, wherein in step c), the integrated deformation sensor detects the deformation state of the deformable component. Attached Figure Description

[0177] Preferably, in conjunction with the dependent claims, other optional features and embodiments will be disclosed in more detail in the following description of embodiments. These optional features, as will be recognized by those skilled in the art, can be implemented individually and in any feasible combination. The scope of the invention is not limited to the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. In these drawings, the same reference numerals refer to the same or functionally equivalent elements.

[0178] In the attached diagram:

[0179] Figures 1A and 1B illustrate exemplary embodiments of the kit according to the invention in cross-sectional view (Figure 1A) and exemplary measurement results (Figure 1B). Detailed Implementation

[0180] Figure 1A shows an exemplary embodiment of the kit 110 according to the present invention in cross-section.

[0181] Kit 110 includes at least one medical device 112. Medical device 112 includes at least one housing 114 that at least partially surrounds at least one sealed chamber 116. The sealed chamber 116 is configured to maintain a pressure difference between at least one interior cavity 118 of the sealed chamber and the surrounding environment 120. Housing 114 includes at least one deformable member 122. Housing 14 is configured such that the deformation state of the deformable member 122 provides a measurable indication of the pressure difference between the interior cavity 118 of the sealed chamber 116 and the surrounding environment 120. Further, the medical device includes at least one invasive portion 124.

[0182] In the embodiment according to FIG1A, the medical device 112 is a device for detecting at least one analyte in a user's bodily fluids, specifically a device for detecting glucose in the user's bodily fluids. The invasive portion 124 can be an analyte sensor 126 for detecting at least one analyte in the user's bodily fluids. Further, the invasive portion 124 can include at least one insertion member 128 for inserting the analyte sensor 126 into the user's body tissue.

[0183] The medical device 112 may include at least one sterile cap 130, specifically at least one removable sterile cap 132, which at least partially surrounds at least a portion of the invasive portion 124 of the medical device 112. As an example, the sterile cap 130 may have an elongated shape. The sterile cap 130 may be substantially rotationally symmetric, for example by having axial rotational symmetry about an axis 134, such as a cylindrical axis or an extended axis.

[0184] The insertion component 128 may specifically include at least one insertion cannula 136. The insertion cannula 136 may be fully or partially received within a sterile cap 130. As an example, the sterile cap 130 may have a closed end 138 and an open end 140, with the insertion cannula 136 protruding from the open end 140 into the sterile cap 130, and the tip 142 of the insertion cannula 136 facing the closed end 138. The analyte sensor 126 may be partially received within the insertion cannula, such as within a groove of the insertion cannula 136. The insertion component 128 may further include at least one retainer 143 for the insertion cannula 136, wherein the retainer 143, the insertion cannula 136, and the sterile cap 130 form components of a sterile container for the analyte sensor 126.

[0185] The medical device 112 may further include at least one electronic unit 144. The electronic unit 144 may include at least one electronic component 146. The electronic unit 144 may further include at least one electronic unit housing 148. The electronic component 146 may be received within the electronic unit housing 148. The analyte sensor 126 may be partially enclosed by the electronic unit housing 148. Specifically, the electronic unit 144 may include at least one electronic unit housing 148, wherein the analyte sensor 126, for example having a proximal end, may protrude into the electronic unit housing 148 and may be electrically connected to at least one electronic component 146 within the electronic unit housing 148.

[0186] In the embodiment according to FIG1A, the medical device 112 may specifically include at least two of housings 114, each having at least one sealed chamber 116. The medical device 112 may specifically have at least one first housing 150 having at least one first sealed chamber 152. Specifically, a sterile cap 130 may at least partially surround the first sealed chamber 152. Further, the medical device 112 may specifically have at least one second housing 150 having at least one second sealed chamber 152. The second housing 154 may be an electronics housing 148, and electronic components 146 may be received within the second sealed chamber 156.

[0187] The medical device 112 may include at least one first deformable member 158 and at least one second deformable member 160. The wall 162 of the sterile cap 130 may include the first deformable member 158. The wall 164 of the electronic unit housing 148 may include the second deformable member 160.

[0188] Furthermore, kit 110 includes at least one external deformation sensor 166 configured to measure the deformation state of deformable member 122. In the embodiment according to FIG1A, kit 110 may include at least one first external deformation sensor 168 configured to measure the deformation state of first deformable member 158 and at least one second external deformation sensor 170 configured to measure the deformation state of second deformable member 160.

[0189] Further, the medical device 112 may have at least one movable component 176. Exemplarily, the movable component 176 may be a cover 180 that closes the invasive portion compartment 180. The cover 180 may correspond to a retainer 143 for inserting the cannula 136. Exemplarily, a sterile cover 130 may form a removable lower cover 182 of the invasive portion compartment 180, and the movable component 176 may form a removable upper cover 184 of the invasive portion compartment 180. An electronics housing 148 may form an intermediate component 186 of the medical device 112, disposed between the sterile cover 130 and the movable component 176. The sterile cover 130 and the movable component 176 may be located on opposite sides of the electronics housing 148. A sealing element 188 may be disposed on the movable component 176 and configured to seal the movable component 176 against the electronics housing 148. A sealing element 188 may be disposed between the movable component 176 and the electronic unit housing 148. The movable component 176 may be detachably connected to the electronic unit housing 148. The movable component 176 and the electronic unit housing 148 may form a multi-component design. The movable component 176 may be detachably inserted into and engaged with the electronic unit housing 148 by means of the sealing element 188. The elastic properties of the sealing element 188 may allow the movable component 176 to move relative to the electronic unit housing 148. Due to the applied relative pressure difference, the movable component 176 may withstand a force corresponding to the pressure difference and may move within the elastic displacement of the sealing element 188, as shown by arrow 200 in FIG. 1A. The movement of the movable component 176 relative to its reset position may be detected by sensor 202, as shown in FIG. 1A, and the integrity of the housing may be assessed.

[0190] Medical device 112 can be inserted into test chamber 172. Pressure can be applied to test chamber 172, for example, via port 173. When subjected to external pressure or vacuum, the first deformable component 158 ​​and the second deformable component 160 can protrude or retract, respectively. For testing, medical device 112 can be placed in test chamber 172, where pressure or vacuum can be applied. Test chamber 172 can contain a first external deformation sensor 168 and a second external deformation sensor 170, which can be displacement sensors 174, respectively. Displacement sensors 174 can be configured to scan the surfaces of the first deformable component 158 ​​and the second deformable component 160. Displacement can be measured using tactile (inductive, incremental, etc.) or non-contact (laser triangulation, confocal, etc.) distance sensors. At the start of the test, the tare weight of displacement sensor 174 can be determined at atmospheric pressure. Test chamber 172 can then be brought to the desired positive or negative pressure. The measurements from displacement sensor 174 can provide positional selectivity information regarding the airtightness of the probed sealed chamber 116. For calibration, both sealed and leaking medical devices 112 can be measured, and the detected deflections can be used as a reference. Attribution results (sealed / unsealed) can be obtained after a fixed measurement time. If deflection of the deformable component 122 is detected during a pressure change, displacement information over that time is obtained. The slope of such a curve can provide information about the size of the leak.

[0191] Figure 1B shows exemplary measurement results. It thus shows the displacement d of the deformable component 122 depending on the measurement time t. Solid lines represent measurement results corresponding to the sealed chamber. Dashed lines represent measurement results corresponding to the slightly leaking chamber. Dotted lines represent measurement results corresponding to the heavily leaking chamber.

[0192] List of reference numerals

[0193] 110 kit

[0194] 112 Medical Device

[0195] 114 housing

[0196] 116 Enclosed Room

[0197] 118 inner cavity

[0198] 120 surrounding environment

[0199] 122 deformable parts

[0200] 124 Intrusion Part

[0201] 126 Analyte Sensors

[0202] 128 Insertion Parts

[0203] 130 Sterile Cap

[0204] 132 Removable Aseptic Cap

[0205] 134 axis

[0206] 136 Insert cannula

[0207] 138 closed end

[0208] 140 open end

[0209] 142 tip

[0210] 143 Holder

[0211] 144 electronic units

[0212] 146 Electronic Components

[0213] 148 Electronic Unit Housing

[0214] 150 First Casing

[0215] 152 First Enclosed Chamber

[0216] 154 Second Shell

[0217] 156 Second Enclosed Chamber

[0218] 158 First Deformable Component

[0219] 160 Second Deformable Component

[0220] 162 wall

[0221] 164 wall

[0222] 166 External Deformation Sensor

[0223] 168 First External Deformation Sensor

[0224] 170 Second External Deformation Sensor

[0225] Test Room 172

[0226] Port 173

[0227] 174 displacement sensors

[0228] 176 movable parts

[0229] 178 covers

[0230] 180 intruded into part of the compartment

[0231] 182 Removable Lower Cover

[0232] 184 Removable Top Cover

[0233] 186 intermediate components

[0234] 188 sealing element

[0235] 200 arrows

[0236] 202 sensor

Claims

1. A medical device (112) having at least one invasive portion (124), the medical device (112) comprising at least one housing (114) at least partially surrounding at least one sealed chamber (116), the sealed chamber (116) being configured to maintain a pressure difference between at least one cavity (118) of the sealed chamber (116) and an ambient environment (120), wherein the housing (114) comprises at least one deformable member (122), wherein the housing (114) is configured such that a deformable state of the deformable member (122) provides a measurable indication of the pressure difference between the cavity (118) of the sealed chamber (116) and the ambient environment (120).

2. The medical device (112) according to the preceding claim, wherein the medical device (112) further comprises at least one integrated deformation sensor configured to measure the deformation state of the deformable component (122).

3. The medical device (112) according to any one of the preceding claims, wherein the wall of the housing (114) includes the deformable component (122).

4. The medical device (112) according to any of the preceding claims, wherein the deformable component (122) forms at least partially a portion of the housing (114) surrounding the sealed chamber (116).

5. The medical device (112) according to any one of the preceding claims, wherein the deformable component (122) has a predefined material strength.

6. The medical device (112) according to any one of the preceding claims, wherein the deformable component (122) comprises at least one material having a tensile strength of 40 MPa to 180 MPa.

7. The medical device (112) according to any one of the preceding claims, wherein the deformable component (122) has a thickness of 0.1 mm to 1.0 mm.

8. The medical device (112) according to any one of the preceding claims, wherein the deformable component (122) is made of at least one material selected from the group consisting of: acrylonitrile butadiene styrene (ABS), polypropylene, polystyrene, polyamide, polycarbonate, polyethylene, polymethyl methacrylate (PMMA), polyoxymethylene (POM), thermoplastic elastomer (TPE), and polysiloxane.

9. The medical device (112) according to any one of the preceding claims, wherein the invasive portion (124) is selected from the group consisting of: at least one analyte sensor (126) for detecting at least one analyte in the body fluids of a user; at least one insertion part (128); at least one infusion cannula; at least one stimulation electrode.

10. The medical device (112) according to the preceding claim, wherein the invasive portion (124) is at least partially received in the sealed chamber (116).

11. The medical device (112) according to the preceding claim, wherein the medical device (112) includes at least one sterile cap (130) at least partially surrounding the invasive portion (124), wherein the deformable component (122) forms part of the wall (162) of the sterile cap (130).

12. The medical device (112) according to any one of the preceding claims, wherein the medical device (112) further comprises at least one electronic unit (144), wherein the electronic unit (144) comprises at least one electronic component (146), wherein the electronic unit (144) further comprises at least one electronic unit housing (148), wherein the electronic component (146) is received in the electronic unit housing (148), wherein the housing (114) is the electronic unit housing (148), wherein the electronic component (144) is received in the sealed chamber (116), and wherein the deformable component (122) forms part of the wall (164) of the electronic unit housing (148).

13. The medical device (112) according to any one of the preceding claims, wherein the medical device (112) is selected from the group consisting of: a pharmaceutical device for delivering at least one therapeutic medical fluid to a user; and a device for detecting at least one analyte in the user's bodily fluids.

14. A kit (110) comprising a medical device (112) according to any of the preceding claims and at least one external deformation sensor (166) configured to measure the deformation state of the deformable component (122).

15. A method for monitoring the integrity of the housing (114) of a medical device (112), the method comprising: a) Provide a medical device (112) according to any one of the preceding claims relating to a medical device (112); b) Place the medical device (112) into the test chamber (172) and apply test pressure to the test chamber (172); c) Detect the deformation state of the deformable component (122), preferably over time; as well as d) Evaluate the integrity of the housing (114) of the medical device (112) based on the deformation state of the deformable component (122).

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