Percutaneous medical device and kit comprising the device

Abstract

A percutaneous medical device (110) specifically for sampling capillary blood is proposed, the percutaneous medical device comprising at least one fixed part (118) and at least one movable part (120). The movable part (120) is movably mounted to the fixed part (118). The movable part (120) is movable from a distal position (154) to a proximal position (156). The movable part (120) includes at least one penetrating element (140) configured to penetrate the user's skin. The penetrating element (140) is received within the fixed part (118) at the distal position (154) of the movable part (120). At the proximal position (156) of the movable part (120), the penetrating element (140) protrudes from the application side (168) of the fixed part (118). The movable component (120) further includes at least one magnetic actuation element (138) configured such that movement of the movable component (120) can be driven by at least one external magnetic force. Furthermore, a body mount (112) for attaching the percutaneous medical device (110) to a user's body surface, a percutaneous medical kit (114) including the percutaneous medical device (110) and the body mount (112), and a method for driving a penetrating element (140) are proposed.

Description

Technical Field

[0001] This invention relates to percutaneous medical devices, body mounts, percutaneous medical kits including percutaneous medical devices and body mounts, and methods for driving penetration elements. The devices and methods according to the invention are specifically applicable to the field of diagnostic sampling in home care and professional medical settings. Specifically, the devices and methods can be used for sampling capillary blood. However, the devices and methods can also be used for other purposes requiring penetration of the user's skin, such as for injection purposes, for example, for injecting one or more liquid medications into body tissues and / or blood vessels. Other applications of the invention are also possible. Background Technology

[0002] Methods and approaches for penetrating a user's skin are widely used, both in home care and in specialized medical settings such as hospitals or nursing homes. The invention will be specifically described below in the context of capillary blood sampling. However, it should be noted that other applications, such as those for injecting medically active ingredients into a user's body tissues and / or blood vessels, are also feasible.

[0003] In order to penetrate a user's skin, in addition to the traditional manual method using manually handled lancets or needles, automated devices are known and becoming increasingly popular. Specifically, methods and approaches for diagnostic sampling of capillary blood are applied in fields such as self-sampling or home sampling. These methods and approaches require skin penetration, specifically at the puncture site of capillary blood vessels. Blood samples (such as droplets of capillary blood) are then collected using appropriate collection methods (such as paper, plasma separation cards, or sample tubes). These samples can then be analyzed at home or by transporting them to an analytical facility. Meanwhile, home sampling is widely used, specifically to avoid frequent visits to doctors or hospitals.

[0004] Self-sampling through the skin typically requires some effort from the user. Automated devices eliminate the need for manual pricking of the fingertip, such as with a needle or lancet, which greatly helps overcome these strenuous operations. Devices for puncturing the skin are commercially available, such as those from Tasso, Inc., Seattle, WA 98119, USA, or YourBio Health, Inc., Medford, MA 02155, USA. These sampling devices are triggered by a button pressed by the user or by pressing the device onto the skin, thereby actuating the device and causing a spring-driven needle or lancet to penetrate the skin.

[0005] US 2008 / 228212 A1 relates to a lancet device by which a lancet can be moved along a puncture path to create a puncture wound on the skin surface, particularly for obtaining bodily fluids for diagnostic purposes. To achieve low-noise and low-impact puncture movement, the lancet actuator may include a control unit for adjusting the puncture depth of the lancet, and the lancet may be configured to extend freely in the puncture direction without being limited by a mechanical puncture depth stop.

[0006] US 2005 / 0125017 A1 describes a lancet device (10) having an internal magnet (20) and a drive collar (30) and a lancet (60) emanating from it, and a force that retracts the collar and the lancet. The device has a steady-state condition (SS) in which it is at rest and in equilibrium. The device can be prepared and activated for puncture. Once puncture occurs, the device returns to the steady-state condition.

[0007] WO 2019 / 226754A1 discloses an apparatus (1) for obtaining biological samples, comprising a blood collection device (10) and a vibration device (80) removably attached to the blood collection device to provide pain relief. The vibration device of this disclosure provides pain relief to the patient by vibrating the blood collection device. The vibration device can be attached to the blood collection device before being placed on the finger to provide pain relief during finger puncture and to facilitate blood flow from the finger into the collection container during the collection process.

[0008] US 6,925,317 B1 describes an alignment device and related systems and methods for aligning at least one device relative to a surface of tissue. The alignment device includes tissue interface members adapted to be positioned on the surface of the tissue and to cooperate with the device to maintain alignment of the device during operation. The alignment device can be used to align various devices as part of a continuous analyte monitoring system.

[0009] However, a common technical challenge with these blood sampling devices lies in controlling the puncture depth. If the puncture depth is too shallow, insufficient blood volume is produced. Conversely, a deep puncture depth increases user discomfort and may lead to excessive blood and contamination of personal items. These challenges are compounded by the fact that the penetration depth is typically increased by the device itself, as the body tissue is compressed by pressing the device against the body surface. Worse still, the penetration depth can vary depending on the characteristics of the body tissue and / or the pressure applied to the body surface by the device.

[0010] Therefore, specifically in the fields of self-sampling or home sampling, and in other areas where percutaneous devices are used, there is a need for devices that produce reliable and repeatable penetration depths, specifically, devices that are largely independent of user behavior and device handling. The penetration produced by the device should be specifically sufficient for sampling (but not excessive) to avoid contamination of the user's personal items by excessive blood. Furthermore, the penetration process (specifically, the process of collecting the sample) should be convenient and straightforward.

[0011] Problems to be solved Therefore, it is desirable to provide a percutaneous medical device, body mount, percutaneous medical kit, and method for driving the penetration element, which at least partially addresses the aforementioned technical challenges of known devices and methods. Specifically, the device and method should be applicable to the fields of blood sampling and / or injection of medically active ingredients. Specifically, the device and method should provide high reliability regarding penetration depth, the amount of body fluid should be reproducible, and the use of the device should be convenient and straightforward. Summary of the Invention

[0012] This problem is addressed by percutaneous medical devices, body mounts, percutaneous medical kits, and methods for driving the penetration element, as described in 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.

[0013] 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 either 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.

[0014] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may exist once or more are generally used only once when introducing the corresponding feature or element. In the following text, in most cases, when referring to the corresponding feature or element, the expressions "at least one" or "one or more" will not be used repeatedly, even though the corresponding feature or element may exist once or more.

[0015] Furthermore, as used below, the terms “preferredly,” “more preferably,” “particularly,” “even more particularly,” “specifically,” “more 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 carried out 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.

[0016] In a first aspect of the invention, a percutaneous medical device is provided. The percutaneous medical device includes at least one fixed component and at least one movable component. The movable component is movably mounted to the fixed component. The movable component is movable from a distal position to a proximal position. The movable component includes at least one penetrating element configured to penetrate the user's skin. The penetrating element at the distal position of the movable component is received within the fixed component. At the proximal position of the movable component, the penetrating element protrudes from the application side of the fixed component. The movable component further includes at least one magnetic actuating element configured such that movement of the movable component can be driven by at least one external magnetic force.

[0017] As used herein, the term "percutaneous" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, the characteristics of a process occurring through a user's skin. Therefore, a process described as "percutaneous" generally involves penetrating the skin by directly creating a penetration or by using an existing penetration. In the following, the term will specifically be used to indicate a device configured for penetrating the skin or to imply a process of skin penetration.

[0018] As used herein, the term "medical device" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. Specifically, the term may refer to, but is not limited to, any device having one or more components configured to perform or facilitate one or more medical actions, such as diagnostic and therapeutic actions.

[0019] As used herein, the term "fixed component" is a broad term and is given a 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 component of a device having one or more elements that is broadly fixed relative to a chosen frame of inertia or coordinate system for its intended use, such as at least one of the following: the coordinate system of a user's hand holding the percutaneous medical device, the coordinate system of the percutaneous medical device itself, or the coordinate system of the user's body surface. Specifically, the term "fixed component" may also be used to distinguish said component from one or more movable parts, such as movable components described in further detail below.

[0020] Similarly, the term "movable part" as used herein is a broad term and is given a 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 component of a device having one or more elements that is movable in a selected inertial frame or coordinate system for its intended use, such as at least one of the following: the coordinate system of a user's hand holding the percutaneous medical device, the coordinate system of the percutaneous medical device itself, or the coordinate system of the user's body surface. Specifically, the term "movable part" can also be used to distinguish said component from one or more fixed parts, such as the fixed parts described above. Therefore, the terms "fixed part" and "movable part" may specifically be used only as terms indicating that a fixed part may define a coordinate system in which the movable part is movable in one or more linear movements and / or one or more nonlinear movements and / or one or more rotational movements.

[0021] As described above, the movable component is movably mounted to the fixed component, allowing the movable component to move from a distal position to a proximal position. Specifically, the movement can be linear. However, other movements are also possible. The fixed component may also provide one or more guiding elements (such as one or more guiding surfaces) configured to guide the movement of the movable component from the distal position to the proximal position. Specifically, as will be described in further detail below, the movement can also be reversible, allowing the movable component to move from the proximal position back to the distal position. In this context, the direction of movement from the distal position to the proximal position can define a penetration direction, while the opposite direction of movement (i.e., movement from the proximal position to the distal position) can define a retraction direction of the movable component.

[0022] As used herein, the terms “distal position” and “proximal position” are broad terms and are given their common and customary meanings to those skilled in the art, and are not limited to specific or customary meanings. Specifically, these terms may be used simply to distinguish the location of a movable part. However, these terms may be specifically used in the context of the intended use of the percutaneous medical device. Thus, in the intended use, a distal position may be the location of the movable part, where the movable part is located furthest from the user's skin, while a proximal position may be the location of the movable part, where the movable part is located closest to the user's skin. Specifically, a proximal position may be the location where, when the percutaneous medical device is applied to a body mount and the body mount is applied to the user's skin, the penetrating element may penetrate the user's skin, as will be described in further detail below. On the other hand, a distal position may be the location where, when the percutaneous medical device is applied to a body mount and the body mount is applied to the user's skin, the penetrating element may be located entirely outside the user's skin.

[0023] As used herein, the term "application side" is a broad term and is given a 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, one side of a fixation component facing the user's body surface in its intended use. Specifically, the application side may include at least one application surface that can be applied directly or indirectly to the user's body surface. Thus, the application surface may rest directly on the body surface, or it may rest on at least one intermediate component between the body surface and the fixation component, such as a body mount described further in detail below. The application surface on the application side may specifically be or may include annular surfaces, such as the annular surface of a sleeve forming a part of the fixation component or thereof. Specifically, the application side (specifically, the application surface of the application side) may be part of the fixation component from which a penetrating element protrudes during penetration.

[0024] On the application side, the percutaneous medical device may further include at least one sealing element and / or a protective element. Thus, as an example, a sterile seal may be provided. As an example, the application side may be completely or partially covered with at least one protective liner that can be removed by the user before using the percutaneous medical device, specifically before applying the percutaneous medical device to the body mount.

[0025] As used herein, the term "penetrating element," also commonly referred to as "needle," is a broad term and is given a 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 configured to penetrate a user's skin and optionally also penetrate the user's body tissue. Specifically, a penetrating element may include at least one of a sharp point and a pointed tip. More specifically, a penetrating element may include at least one of a needle and a conduit. The penetrating element may have an elongated shape, with the sharp point or tip located at the proximal end of the penetrating element. The penetrating element may be made wholly or partially of a solid material or element, or it may be made as a hollow or slotted element. As an example, a penetrating element may be made of at least one of a metallic material and a plastic material. However, other materials are also feasible.

[0026] The movable component may include a movable body, such as a movable body formed as a solid cylinder or block, or a hollow movable body (such as a movable shell), the hollow movable body having one or more movable internal spaces in which a penetrating element is mounted, such as the penetrating element protruding from the movable body on the side facing the application side. The movable body may include one or more components (such as a movable upper portion and a movable lower portion), which may be engaged during assembly by one or more connecting elements. The at least one movable internal space may be located between the movable upper portion and the movable lower portion, and one or more additional components may be received therein, such as a magnetic drive element and / or a needle holder for retaining the penetrating element. As an example, the movable body may be made of a plastic material, while the penetrating element as described above may be made of, for example, a metallic material. Specifically, the movable body of the movable component may be made by molding techniques (such as injection molding), and the penetrating element may be integrated therein or mounted thereto, for example, by material bonding (such as by insert molding). However, other techniques are also feasible.

[0027] As further described above, in the distal position of the movable member, the penetrating element is received within the fixed member, and in the proximal position of the movable member, it protrudes from the application side of the fixed member. Thus, in the distal position, the fixed member can act as a housing that completely or partially surrounds the penetrating element and may surround other portions of the movable member, such as at least a portion of the aforementioned movable body of the movable member. However, in the proximal position of the movable member, the penetrating element can specifically protrude from the application side of the fixed member. Specifically, the fixed member can provide a housing (such as a sleeve) from which the movable member can move (specifically slide) from the distal position to the proximal position, wherein, in the distal position, the penetrating element is completely circumferentially surrounded by the sleeve formed by the fixed member, and wherein, in the proximal position, the penetrating element protrudes from the application side, specifically from the sleeve, and more specifically from an opening surrounded by the edge of the sleeve.

[0028] As used herein, the term "magnetic drive element" is a broad term and is given a 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 magnetic element as part of at least one drive mechanism of at least one component for driving a system or device. A magnetic drive element may specifically include at least one magnetic material, such as at least one permanent magnet. The magnetic material may be formed or may be formed into a permanent magnet, or alternatively may be integrated into one or more other components, such as through a magnetic drive element comprising magnetic particles as filler material in a plastic material. Various alternatives are possible. The magnetic drive element is integrated or attached to a movable part such that movement of the movable part can be controlled by at least one external magnetic force. As used herein, the term "external magnetic force" is also a broad term and is given a common and customary meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically, but is not limited to, refer to the fact that the magnetic force applied to the movable part originates at least in part from the magnetic attraction and / or magnetic repulsion between the magnetic drive element and another magnetic element that is not part of the percutaneous medical device, such as the magnetic trigger element of a body mount as described further in detail below. Therefore, the external magnetic force consists at least in part of the force between the magnetic drive element of the percutaneous medical device and at least one other magnetic element. More specifically, in a resting or unused position, the percutaneous medical device can be configured such that the movable part is in a distal position. The magnetic drive element can then be configured such that the external magnetic force can be an attractive or repulsive force that drives the magnetic drive element and the movable part into a proximal position. As an example, and as will be described further in detail below, a body mount can be provided on the user's skin, wherein the body mount includes a magnetic trigger element, wherein, when the percutaneous medical device is attached to the body mount, the magnetic trigger element drives the magnetic drive element and the movable part from a distal position to a proximal position, specifically by magnetically attracting the magnetic drive element.

[0029] As described above, the fixing component may specifically include a sleeve. As an example, the sleeve may be made wholly or partially of a plastic material. Specifically, the sleeve may be a cylindrical sleeve, such as a cylindrical sleeve with a circular cross-section. The sleeve may be closed on one side, for example, on the side facing the user's skin or on the application side. The closure may contain an opening for penetrating the element to protrude from the application side through the opening. At least one guide surface may be provided on the inner side of the sleeve, along which the movable component can slide. Therefore, the movable component can be received within the sleeve. Specifically, the movable component can be slidably received within the sleeve.

[0030] As further described above, the magnetic drive element can be implemented in various ways, such as by providing a solid permanent magnet or by integrating magnetic particles into a plastic material, such as the plastic material of the movable part. However, specifically, the magnetic drive element may include at least one permanent magnet. The permanent magnet may specifically include a cylindrical permanent magnet, such as a permanent magnet having a disk-shaped or ring-shaped form. Specifically, the permanent magnet may be one or more integrated into and attached to the movable part. More specifically, the permanent magnet may be attached to the movable part on the side facing the application side. Additionally or alternatively, the permanent magnet may also be received within the movable part, such as within at least one movable internal space within the movable part.

[0031] As described above, the direction of movement of the movable part from a distal position to a proximal position can be defined as the penetration direction. The percutaneous medical device may further include at least one retraction spring configured to apply a spring force to the movable part, the spring force being configured to move the movable part from the proximal position to the distal position, specifically against an external magnetic force, i.e., to the aforementioned retraction direction opposite to the penetration direction. The external magnetic force is sized such that when the percutaneous medical device is closest to the user's skin, the external magnetic force overcomes the spring force applied by the retraction spring, and when the percutaneous medical device is removed from the body surface, the retraction spring applies a spring force overcoming the external magnetic force, causing the movable part to move from the proximal position back to the distal position. For example, the position and size of the magnetic trigger element of the body mount, as further defined in detail below, can satisfy the above conditions: when the percutaneous medical device is positioned away from the body mount, the retraction spring can hold the movable part in the distal position, while when the percutaneous medical device is attached to the body mount, the external magnetic force applied to the magnetic drive element by the magnetic trigger element exceeds the spring force applied by the retraction spring, so the movable part moves from the distal position to the proximal position, thereby driving the penetrating element into the user's skin.

[0032] As described above, the fixing member may provide at least one receiving portion or space, also referred to as a fixed internal space, in which the movable member can move, specifically slide. More specifically, the fixing member may provide at least one sliding surface, such as the inner circumferential surface of the sleeve of the fixing member. The fixing member may include one or more additional elements that guide and / or restrict the movement of the movable member. Specifically, the fixing member may include at least one stop that defines at least one of a distal position and a proximal position. Specifically, the fixing member may include at least two stops that define a distal position and a proximal position. As an example, these at least two stops may be defined by one or more adjacent surfaces that restrict the movement of the movable member.

[0033] As described above, a percutaneous medical device can be specifically configured for sampling bodily fluids, specifically capillary blood. For this purpose, the penetrating element can simply create an opening in the user's skin and / or body tissue, specifically in at least one capillary. From at least one opening, capillary blood or other bodily fluids can simply leak out and be collected manually by the user or through a separate sampling element (such as one or more sampling papers or tubes). However, the percutaneous medical device may also include at least one integrated element for sampling, such as at least one sampling element configured to receive at least one sample of bodily fluid from an incision created by the penetrating element in the user's skin. As an example, the sampling device may include at least one sampling tube, specifically a sampling tube received within a movable part. Bodily fluids can be drawn into the sampling device (specifically the sampling tube) by capillary forces or other forces (such as negative pressure applied to the bodily fluid). Specifically, the percutaneous medical device may further include at least one aspiration element for aspirating at least one sample of bodily fluid, specifically, the at least one aspiration element applying negative pressure to the sampling element. As an example, the aspiration element may include a reservoir in which a pressure lower than that of ambient air may be present. The reservoir is fluidly connected to the sampling element such that the low pressure in the reservoir draws bodily fluid into the sampling element. Additionally or alternatively, the percutaneous medical device may further include an aspiration element with an actuator for generating a low or negative pressure to draw bodily fluid into the sampling device, such as a user-operated actuator and / or an automated actuator that can be coupled to one or more other actions, such as attaching the percutaneous medical device to a body mount, removing the percutaneous medical device from a body mount, or magnetic actuation. Other options are also possible.

[0034] In addition to or as an alternative to sampling, percutaneous medical devices are at least partially configured as sampling devices as discussed above, and can also be wholly or partially implemented as injection devices. Thus, percutaneous medical devices can be configured to inject at least one medically active ingredient into a user's body tissue, specifically through a penetrating element. Therefore, as an example, the penetrating element can be wholly or partially configured as an injection needle or injection catheter. The percutaneous medical device may further include at least one reservoir for holding the medically active ingredient. As an example, the reservoir may be, or may contain, a liquid reservoir for holding one or more liquid medically active ingredients.

[0035] As described above and will be discussed in further detail below, a percutaneous medical device can be configured for attachment to a body mount. Specifically, the body mount may contain a magnetic triggering element for applying an external magnetic force to the percutaneous medical device. For attachment purposes, the percutaneous medical device may specifically include at least one device engagement element on the application side for engaging with a body mount engagement element of the body mount attached to the user's body surface. Specifically, the device engagement element may be configured to mechanically engage with a mechanical body mount engagement element. More specifically, the engagement may be one or more of a form-fit and force-fit connection. The engagement may be adapted or configured to hold the percutaneous medical device in a suitable position on the user's skin in one or more dimensions, such as in a plane (such as a tangential plane) partially defined by the body mount or the body surface; however, optionally, movement in a direction perpendicular to this plane is possible to remove the percutaneous medical device from the body mount. As an example, the device engagement element may include at least one edge of a retaining member, and the body mount engagement element may be received within the edge. As an example and as discussed above, the fixation component may include a sleeve having a circular or polygonal edge surrounding an opening into which a corresponding cylindrical body mount engagement element may be inserted. As an example and as will be discussed in further detail below, the cylindrical body mount engagement element may specifically include a magnetic trigger element, such that the edge of the fixation component may specifically surround the magnetic trigger element completely or partially when engaged with a percutaneous medical device attached to the body mount.

[0036] In a further aspect of the invention and as already mentioned above, a body mount is provided, configured to attach a percutaneous medical device according to the invention to a user's body surface, such as a percutaneous medical device according to any of the embodiments described above and / or any of the embodiments described in further detail below. The body mount includes at least one application surface for application to the body surface. As already mentioned above, the body mount further includes at least one body mount engagement element on a side opposite the application surface for engagement with the percutaneous medical device, specifically with at least one device engagement element of the percutaneous medical device. Further, as already mentioned above, the body mount further includes at least one magnetic trigger element configured to apply an external magnetic force to the percutaneous medical device to magnetically attract a magnetic drive element of the percutaneous medical device when attached to the body mount.

[0037] For most definitions and selections of body mounts, refer to the description of percutaneous medical devices above. As used herein, the term "body mount" is a broad term and is given a 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 device configured to mount at least one additional device or component to a user's body surface. As an example, a body mount may include one or more fixing elements for securing the body mount to a body surface, such as one or more adhesives. Thus, as an example, a body mount may be implemented wholly or partially as an adhesive patch. For mounting one or more additional devices or components to a user's body surface, a body mount includes body mount engagement elements.

[0038] In the specific embodiments described herein, the body mount is configured to attach a percutaneous medical device to a body surface. Therefore, the body mount can specifically act as an intermediate component between the percutaneous medical device and the user's body surface, wherein the body mount is attached to the body surface via an application surface, and wherein the body mount is further connectable to or attachable to the percutaneous medical device on a side opposite to the body surface.

[0039] As used herein, the term "application surface" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term may specifically refer to, but is not limited to, the surface of an element to which our element can be applied. In this example, the application surface specifically refers to a surface that comes into direct or indirect contact with a user's body surface (e.g., via one or more adhesive layers). Specifically, the application surface may contain one or more adhesives.

[0040] As used herein, the terms “device engaging element” and “body mount engaging element” are broad terms and are given common and customary meanings to those skilled in the art, and are not limited to specific or customary meanings. These terms may specifically refer to, but are not limited to, elements of a percutaneous medical device or body mount configured to engage with each other to attach the percutaneous medical device (specifically, reversibly) to the body mount. Thus, engaging elements typically include corresponding mechanical structures configured to mechanically interact with each other to provide a connection between the percutaneous medical device and the body mount, specifically adapted to hold the percutaneous medical device in a dedicated position on the body mount in one or more dimensions (e.g., as mentioned above, in a plane defined by a body surface or by the body mount). More specifically, the connection may be a reversible mechanical connection. Therefore, as an example, engaging elements may include complementary mechanical structures configured to engage with each other, for example, according to a lock-and-key principle. As discussed above, as an example, the device engagement element may include the circumferential edge of the fixation component of the percutaneous medical device, while the body mount engagement element may include a corresponding protrusion on the body mount that (specifically with low mechanical tolerances) mates into an opening defined by the edge to provide precise positioning of the percutaneous medical device on the body mount. As further discussed above, the protrusion on the body mount may specifically be formed by or at least contain a magnetic triggering element.

[0041] As discussed above, the body mount further includes at least one magnetic triggering element configured to apply an external magnetic force to the percutaneous medical device so as to magnetically attract the magnetic drive element of the percutaneous medical device when it is attached to the body mount. As used herein, the term "magnetic triggering element" is a broad term and is given a 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 magnetic element configured to apply an external magnetic force to the percutaneous medical device, specifically to the magnetic drive element of a movable part, for the purpose of moving the movable part from a distal position to a proximal position.

[0042] The magnetic triggering element may specifically include at least one magnetic material, such as at least one permanent magnet. The magnetic material may be formed or may be formed into a permanent magnet, or alternatively may be integrated into one or more other components, such as by means of a magnetic drive element comprising magnetic particles as filler material in a plastic material. Specifically, the magnetic triggering element may also be implemented as a toroidal magnet. The toroidal magnet may be configured to rest on a user's body surface, wherein a body mount engagement element may be wholly or partially formed by the toroidal magnet, and wherein a penetrating element of a percutaneous medical device attached to the body mount may protrude into the user's body tissue at a proximal position through a central opening of the toroidal magnet. Therefore, specifically, the application surface of the body mount may also be wholly or partially formed by the magnetic triggering element, for example, by the annular anterior surface of the magnetic triggering element resting on the user's skin. Various alternatives are possible.

[0043] Magnetic triggering elements can be integrated into or attached to a body mount, such as into a base or frame of the body mount, for example, a base or frame forming an application surface. Thus, as an example, a body mount can contain at least one base element, which, for example, forms or has an application surface, wherein the magnetic triggering element is one or both mounted to and integrated into the base element, wherein, specifically, the magnetic triggering element may form a protrusion projecting from the base element on a side opposite to the body surface. However, the base element may also be at least partially and specifically entirely formed of a magnetic triggering element.

[0044] As described above, the body mount can specifically be configured for attachment to a user's body surface. More specifically, the body mount may further include at least one adhesive element for attaching the application surface to the user's body surface, specifically at least one adhesive patch. As described above, the magnetic triggering element may specifically include at least one permanent magnet, such as a cylindrical toroidal magnet or a ring magnet, specifically a permanent magnet attached to the adhesive patch. During penetration, the penetration element can move through a central opening in the toroidal magnet and optionally through an opening in the patch, through the user's skin, and into the body tissue.

[0045] As further described above, the body mounting engagement element can be fully or partially integrated with the magnetic triggering element, specifically with a permanent magnet. Thus, the permanent magnet itself can protrude from the body surface and engage with, for example, a fixing component and device engagement element (such as an opening surrounded by the edge of the fixing component). Therefore, specifically, the magnetic triggering element can be a toroidal magnetic triggering element, and the size of the opening defined by the edge of the fixing component allows the toroidal magnetic triggering element to fit within the opening.

[0046] In a further aspect of the invention, a percutaneous medical kit is proposed. This percutaneous medical kit includes at least one percutaneous medical device according to the invention, such as any of the embodiments described above, or according to any of the embodiments further described in detail below. Further, the percutaneous medical kit includes at least one body mount according to the invention, such as any of the embodiments described above, or according to any of the embodiments further described in detail below.

[0047] As used herein, the term "kit" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, a plurality of components configured to interact to achieve at least one purpose. Similarly, as used herein, the term "medical kit" is a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, a kit configured to achieve at least one medical purpose (such as diagnostic and / or therapeutic purposes). Furthermore, and even further, as used herein, the term "percutaneous medical kit" is also a broad term and is given a common and conventional meaning to those skilled in the art, and is not limited to a specific or customary meaning. The term can specifically refer to, but is not limited to, a medical kit configured to perform at least one percutaneous action as defined above.

[0048] In a percutaneous medical kit, the percutaneous medical device may specifically include at least one device engagement element as defined above. The device engagement element and the body mount engagement element may be configured to interact such that when the percutaneous medical device is attached to the body mount, the percutaneous medical device is aligned, specifically self-aligned, and more specifically self-centering aligned. This alignment (specifically self-aligned or even self-positioning) may be specifically achieved by the options described above, wherein the magnetic trigger element is formed as a cylindrical magnet (specifically a cylindrical toroidal magnet) which may be directly or indirectly mounted to the body surface, and wherein the magnetic trigger element forms or is part of the body mount engagement element. Further, also as discussed above, the device engagement element may be wholly or partially formed from the edge of the percutaneous medical device (specifically the edge of the fixing component of the percutaneous medical device), wherein the size of the opening surrounded by the edge allows the magnetic trigger element to be inserted into the opening.

[0049] As described above, the magnetic triggering element and the magnetic driving element can be specifically configured such that when the body mount engagement element is fully engaged with the percutaneous medical device (specifically with the device engagement element of the percutaneous medical device), the penetrating movement of the movable part is triggered by the magnetic triggering element.

[0050] As described above, a percutaneous medical kit may include one or more additional components. Therefore, as an example, a percutaneous medical kit and / or percutaneous medical device may include one or more housings or packages that may completely or partially enclose the percutaneous medical device and body mount. Further, the percutaneous medical kit and / or percutaneous medical device may include one or more protective devices, for example, for holding movable parts in a safe position (e.g., in a distal position) for transport before use (such as during storage). As an example, the protective device may be configured to prevent movement of the movable parts from a distal position to a proximal position. The user can remove the protective device before use. As an example, the protective device may include clamps, pins, etc., to secure the percutaneous medical device.

[0051] In a further aspect of the invention, a method for driving at least one penetrating element is proposed. The method includes the following steps, which may be performed in a specific order. However, different orders are also possible. Further, two or more, or even all, of the method steps may be performed consecutively, overlapping in time, or even simultaneously. Further, one or more, or even all, of the method steps may be performed once or multiple times. The method may contain additional method steps not listed.

[0052] The method includes the following steps: a. A percutaneous medical device comprising at least one fixed member and at least one movable member, wherein the movable member is mounted to the fixed member in a manner movable relative to the fixed member, wherein the movable member is movable from a distal position to a proximal position, wherein the fixed member includes an application side, wherein the movable member includes at least one penetrating element configured to penetrate a user's skin, wherein the penetrating element is received within the fixed member at a distal position of the movable member, and wherein the penetrating element protrudes from the application side of the fixed member at a proximal position of the movable member, wherein the movable member further includes at least one magnetic actuating element, wherein the magnetic actuating element is configured such that movement of the movable member can be driven by at least one external magnetic force; b. Providing a body mount configured to attach a percutaneous medical device to a user's body surface, wherein the body mount includes at least one application surface for application to the body surface, wherein the body mount further includes at least one body mount engagement element on a side opposite the application surface, the at least one body mount engagement element for engagement with the percutaneous medical device, specifically engagement with at least one device engagement element of the percutaneous medical device, and wherein the body mount further includes at least one magnetic triggering element; c. Attaching the body assembly to the user's skin; and d. Attaching a percutaneous medical device to a body mount, wherein the percutaneous medical device engages with a coupling element of the body mount, wherein a magnetic triggering element of the body mount applies an external magnetic force to the percutaneous medical device, thereby magnetically attracting a magnetic drive element of the percutaneous medical device.

[0053] Specifically, the method can utilize one or more of the percutaneous medical devices, body mounts, and percutaneous medical kits according to the present invention, such as any of the embodiments described above and / or any of the embodiments described in further detail below. Therefore, possible embodiments and definitions of the method can be found in the description of the percutaneous medical devices, body mounts, or percutaneous medical kits.

[0054] The methods for percutaneous medical devices, body mounts, percutaneous medical kits, and driven penetration elements presented in this paper offer numerous advantages compared to known similar devices, systems, and methods.

[0055] Therefore, specifically, the technical challenges of the aforementioned known methods and approaches are effectively solved. The apparatus and method according to the invention specifically provide reproducible and precise depths of puncture penetration into the user's body tissue. Thus, inconvenience to the user can be effectively reduced. Nevertheless, by providing reliable puncture depth, a sufficient quantity of high-quality blood can be produced. Furthermore, given the simple processing and the reproducible amount of blood produced, contamination of the user's personal belongings can be avoided.

[0056] Furthermore, this invention effectively addresses the psychological issues involved in home care, self-testing, or self-monitoring. Therefore, since the puncture process can occur largely automatically when the user attaches the percutaneous medical device to the body mount, skin penetration requires less effort from the user. The process remains simple and convenient, allowing for the generation and preparation of bodily fluid samples for further processing and analysis in a rapid, reliable, clean, convenient, and efficient manner. Samples can then be processed according to the specific requirements of the situation, such as analysis by the user themselves, or transported to an appropriate analytical facility.

[0057] From a technical perspective, this invention also offers numerous advantages over known devices and methods of the same kind. Specifically, the percutaneous device can be designed such that triggering does not require applying pressure to the user's skin or body surface. Triggering is simply performed by attaching the percutaneous device to the body mount, which can be done without any pressure. Therefore, compression or squeezing of body tissue can be avoided, which, as mentioned above, can adversely affect the repeatability of puncture depth. This is essentially because the compression of body tissue generally depends on its composition, such as softness, water content, body fat content, etc. Therefore, in conventional systems, applying pressure to body tissue leads to compression, and thus, puncture depth, which can vary even if the pressure applied to the body tissue can be the same. This problem can be overcome at least in part by using the present invention's magnetic triggering mechanism, which avoids applying pressure.

[0058] Furthermore, this invention simplifies the positioning of puncture sites. The body mount can be precisely placed by the user on the desired puncture site, for example, by using a ring magnet on the body mount as a positioning aid. Alternatively, other positioning aids can be used and may also be present in the body mount, such as reference markers. Since the application of the percutaneous medical device to the body mount is supported by magnetic attraction, this invention implies self-centering or self-positioning of the percutaneous medical device on the body mount.

[0059] In summary, and without excluding other possible embodiments, the following embodiments are conceivable: Example 1: A percutaneous medical device comprising at least one fixed member and at least one movable member, wherein the movable member is mounted to the fixed member in a manner movable relative to the fixed member, wherein the movable member is movable from a distal position to a proximal position, wherein the fixed member includes an application side, wherein the movable member includes at least one penetrating element configured to penetrate the user's skin, wherein the penetrating element is received within the fixed member at a distal position of the movable member, and wherein the penetrating element protrudes from the application side of the fixed member at a proximal position of the movable member, wherein the movable member further includes at least one magnetic actuating element configured such that movement of the movable member can be driven by at least one external magnetic force.

[0060] Example 2: The percutaneous medical device according to the foregoing examples, wherein the fixing component includes a sleeve, specifically a cylindrical sleeve.

[0061] Example 3: The percutaneous medical device according to the foregoing embodiments, wherein the movable component is slidably received within a cannula.

[0062] Example 4: A transdermal medical device according to any one of the foregoing embodiments, wherein the magnetic drive element comprises a permanent magnet.

[0063] Example 5: The percutaneous medical device according to the foregoing examples, wherein the permanent magnet includes a cylindrical permanent magnet.

[0064] Example 6: A percutaneous medical device according to any one of the preceding two embodiments, wherein a permanent magnet is attached to a movable part on the side facing the application side.

[0065] Example 7: The percutaneous medical device according to any one of the foregoing embodiments further includes at least one retraction spring configured to apply a spring force to a movable member, the spring force being configured to move the movable member from a proximal position to a distal position, specifically resisting an external magnetic force.

[0066] Example 8: According to the percutaneous medical device described in the foregoing embodiments, when the percutaneous medical device is removed from the body surface, specifically when the percutaneous medical device is removed from the body mounting, the spring force of the retraction spring is configured to overcome the external magnetic force, causing the movable part to move from the proximal position back to the distal position.

[0067] Example 9: A percutaneous medical device according to any one of the foregoing embodiments, wherein the fixation component includes at least one stop defining at least one of a distal position and a proximal position, specifically, a stop defining a distal position and a stop defining a proximal position.

[0068] Example 10: A percutaneous medical device according to any one of the foregoing embodiments, wherein the percutaneous medical device is configured for sampling bodily fluids (specifically capillary blood), wherein the percutaneous medical device further includes at least one sampling element, wherein the sampling element is configured to receive at least one sample of bodily fluid from an incision created by a penetrating element in the user's skin.

[0069] Example 11: The percutaneous medical device according to the foregoing embodiments, wherein the sampling device includes at least one sampling tube, specifically, the sampling tube is received within a movable part.

[0070] Example 12: A percutaneous medical device according to any one of the foregoing two embodiments, wherein the percutaneous medical device further includes at least one aspiration element for aspirating at least one sample of body fluid, specifically, at least one aspiration element applies negative pressure to a sampling element.

[0071] Example 13: A percutaneous medical device according to any one of the foregoing embodiments, wherein the percutaneous medical device is configured to inject at least one medically active ingredient into a user’s body tissue, specifically through a penetrating element.

[0072] Example 14: A transdermal medical device according to the foregoing embodiments, wherein the transdermal medical device further includes at least one reservoir for holding a medically active ingredient.

[0073] Example 15: A percutaneous medical device according to any one of the foregoing embodiments, wherein the percutaneous medical device includes at least one device engagement element on the application side for engaging with a body mount engagement element attached to a body mount attached to the user's body surface.

[0074] Example 16: A percutaneous medical device according to the foregoing embodiments, wherein the device engagement element includes at least one edge of the fixation member, wherein the body mount engagement element may be received within the edge.

[0075] Example 17: A body mount for attaching a percutaneous medical device according to any one of the foregoing embodiments to a user's body surface, wherein the body mount includes at least one application surface for application to the body surface, wherein the body mount further includes at least one body mount engagement element on a side opposite to the application surface for engagement with the percutaneous medical device, specifically engagement with at least one device engagement element of the percutaneous medical device, and wherein the body mount further includes at least one magnetic trigger element configured to apply an external magnetic force to the percutaneous medical device to magnetically attract a magnetic drive element of the percutaneous medical device when the percutaneous medical device is attached to the body mount.

[0076] Example 18: The body mount according to the foregoing embodiments further includes at least one adhesive element (specifically at least one adhesive patch) for attaching the application surface to the user's body surface.

[0077] Example 19: A body mount according to any of the foregoing embodiments relating to a body mount, wherein the magnetic triggering element includes at least one permanent magnet, specifically attached to an adhesive patch.

[0078] Example 20: The body mounting component according to the foregoing embodiment, wherein the permanent magnet includes a cylindrical annular magnet.

[0079] Example 21: A body mount according to any of the foregoing embodiments relating to a body mount, wherein the body mount engagement element is at least partially integrated with a magnetic triggering element, specifically with a permanent magnet.

[0080] Example 22: A percutaneous medical kit comprising at least one percutaneous medical device according to any of the foregoing embodiments relating to percutaneous medical devices, and further comprising at least one body mount according to any of the foregoing embodiments relating to body mounts.

[0081] Example 23: The percutaneous medical kit according to the foregoing embodiments, wherein the device engagement element and the body mount engagement element are configured to interact such that when the percutaneous medical device is attached to the body mount, the percutaneous medical device is aligned, specifically self-aligned, and more specifically self-centering.

[0082] Example 24: A percutaneous medical kit according to any of the foregoing embodiments relating to a percutaneous medical kit, wherein the magnetic triggering element and the magnetic driving element are configured such that when the body mount engagement element is fully engaged with the percutaneous medical device, specifically with the device engagement element of the percutaneous medical device, the penetrating movement of the movable part is triggered by the magnetic triggering element.

[0083] Example 25: A method for driving at least one penetrating element, the method comprising: a. A percutaneous medical device comprising at least one fixed member and at least one movable member, wherein the movable member is mounted to the fixed member in a manner movable relative to the fixed member, wherein the movable member is movable from a distal position to a proximal position, wherein the fixed member includes an application side, wherein the movable member includes at least one penetrating element configured to penetrate a user's skin, wherein the penetrating element is received within the fixed member at a distal position of the movable member, and wherein the penetrating element protrudes from the application side of the fixed member at a proximal position of the movable member, wherein the movable member further includes at least one magnetic actuating element, wherein the magnetic actuating element is configured such that movement of the movable member can be driven by at least one external magnetic force; b. Providing a body mount configured to attach a percutaneous medical device to a user's body surface, wherein the body mount includes at least one application surface for application to the body surface, wherein the body mount further includes at least one body mount engagement element on a side opposite the application surface, the at least one body mount engagement element for engagement with the percutaneous medical device, specifically engagement with at least one device engagement element of the percutaneous medical device, and wherein the body mount further includes at least one magnetic triggering element; c. Attaching the body assembly to the user's skin; and d. Attaching a percutaneous medical device to a body mount, wherein the percutaneous medical device engages with a coupling element of the body mount, wherein a magnetic triggering element of the body mount applies an external magnetic force to the percutaneous medical device, thereby magnetically attracting a magnetic drive element of the percutaneous medical device. Attached Figure Description

[0084] Other optional features and embodiments will be disclosed in more detail in the following description of embodiments, in conjunction with the dependent claims. As those skilled in the art will recognize, each optional feature 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.

[0085] In the attached diagram: Figure 1 shows an exploded view of an embodiment of the percutaneous medical kit; Figure 2 shows a cross-sectional view of the percutaneous medical device of the percutaneous medical kit of Figure 1 in its initial state; Figure 3 shows the triggered state after being attached to the body mount of the percutaneous medical kit of Figure 1. Figure 2 A cross-sectional view of a percutaneous medical device; Figure 4 shows a perspective view of the percutaneous medical device of Figures 1 to 3 with additional protective devices; and Figure 5 shows a flowchart of an embodiment of a method for driving at least one penetrating element. Detailed Implementation

[0086] In Figures 1 through 4, exemplary embodiments of the percutaneous medical device 110, body mount 112, and percutaneous medical kit 114 are shown in various views. Figure 1 is an exploded view of the percutaneous medical kit 114. Figure 2 shows the percutaneous medical device 110 in its initial state in a cross-sectional view. Figure 3, also a cross-sectional view, shows the percutaneous medical device 110 in its triggered state after being attached to the body mount 112. Figure 4 shows the percutaneous medical device 110 with an additional protective device 116 serving as a safety device in a perspective view. The following description will be based on these figures.

[0087] As shown in the exploded view of Figure 1, the percutaneous medical kit 114 includes a percutaneous medical device and a body mount 112 attached to the user's body surface. The percutaneous medical device 110 includes a fixed component 118 and a movable component 120. In this embodiment, the movable component 120 specifically includes two elements: a movable lower portion 122 and a movable upper portion 124. The movable lower portion 122 and the movable upper portion 124 are formed as hollow portions (specifically, hollow sleeves) and are nested together and joined by connectors (such as snap-fit ​​connectors 126), as shown in Figures 2 or 3, for example. As an example, the snap-fit ​​connector 126 may be formed by a corrugated edge 128 of the movable lower portion 122 and a circumferential flange 130 of the movable upper portion 124.

[0088] A movable lower portion 122 and a movable upper portion 124 surround a movable internal space 132, as can be seen in Figures 2 and 3. In this embodiment, within this movable internal space 132, a needle holder 134 can be implemented by the movable upper portion 124, for example, being clamped and held in place. As an example, the needle holder 134 can surround a needle holder space 136, and as an example, can be formed as a housing and / or can have a cup shape, as shown in Figures 1 through 3. In this embodiment, a magnetic drive element 138 is received and mounted within the needle holder space 136; as an example, the magnetic drive element can be in the form of a toroidal permanent magnet.

[0089] The needle holder 134 holds the penetrating element 140 on its underside. As an example, the penetrating element 140 may have the shape of a hollow needle or a conduit. As an example, the penetrating element 140 may have a pointed end, a tip 142, or a sharp point on its proximal end.

[0090] The percutaneous medical device 110 may further include at least one sampling element 144. (See Figures 1 to...) Figure 4 In the illustrated embodiment, the sampling element 144 may specifically have a tubular shape. The sampling element 144 may be fluidly connected to a channel within the penetrating element 140, such as the lumen of a conduit or hollow needle. The sampling element 144 may specifically be received within a movable member 120.

[0091] The percutaneous medical device 110 may further include at least one return spring 146. As an example, the return spring 146 may be located within a fixed internal space 148 formed by the fixing member 118. Therefore, as an example, the fixing member 118 may have the shape of a cylindrical sleeve or housing, in which the movable member 120 is received. The return spring 146 may be inserted within the fixed internal space 148 between the front plate 150 of the fixing member 118 and the front plate 152 of the movable member 120.

[0092] The movable component 120 (e.g., by being received within a fixed internal space 148) is mounted to the fixed component 118 in a manner movable relative to the fixed component 118. Thus, by comparing Figures 2 and 3, it can be seen that the movable component 120 can be moved from a distal position 154 (as shown in the configuration of Figure 2) to a proximal position 156 (as depicted in Figure 3). Specifically, the movement can occur in a sliding manner, wherein the circumferential outer surface 158 of the movable component 120 slides on the circumferential inner surface 160 of the sleeve of the fixed component 118. The movement of the movable component 120 can be limited by at least one stop. In the exemplary embodiment shown, the fixed component 118 may be provided with an upper stop 162, and may further optionally be provided with a lower stop 164. As an example, the upper stop 162 can be formed by the corrugated edge of the sleeve of the fixed member 118, wherein a portion of the movable member 120 (e.g., the upper side of the corrugated edge 128) abuts the edge, thereby defining a distal position of the movable member 120. As an example, the lower stop 164 can be formed by a protrusion of the front plate 150 of the fixed member 118 that protrudes into the fixed internal space 148. As an example, the proximal position 156 can be defined by the protruding lower edge 166 of the movable member 120 adjacent to the protruding lower edge 166. As an example, the protruding edge 166 can be an injection-molded protrusion for retaining the movable member 120 of the penetrating element 142. However, it should be noted that many other technical implementations of the upper and lower stops 162, 164 are feasible. Thus, as an example, the lower stop 164 can also be simply implemented by fully compressing the return spring 146.

[0093] The fixation member 118 has an application side 168. On this application side 168, the percutaneous medical device 110 can face the user's skin during penetration. As shown in Figures 2 and 3, the fixation member 118 may (specifically within the front panel 150) have an opening 170. Specifically, the opening 170 (along with the penetrating element 140) may be located on a penetrating axis 172, which may also form an axis of symmetry of the percutaneous medical device 110 and define the direction of movement of the movable member 120. As described above, the movable member 120 can move from a distal position 154 to a proximal position 156 and optionally return to the distal position 154. When in the distal position 154, the penetrating element 140 can be fully received within the fixed internal space 148 of the fixation member 118. When in the proximal position 156, the penetrating element 140 protrudes from the application side 168 of the percutaneous medical device 110. Therefore, specifically in the embodiments shown in Figures 2 and 3, the penetrating element 140 may protrude through the opening 170 on the application side 168.

[0094] In addition to the percutaneous medical device 110, as described above, the percutaneous medical kit 114 further includes a body mount 112. The body mount 112 is configured to attach the percutaneous medical device 110 to a user's body surface. For this purpose, the body mount 112 may include an application surface 174. Specifically, the application surface 174 may include at least one adhesive 176 for attaching the body mount 112 to the body surface. Thus, as an example, the body mount 112 (specifically, the application surface 174 of the body mount 112) may include an adhesive patch, optionally having a removable liner, which can be adhesively attached to the body surface before assembling the entire percutaneous medical kit 114 by attaching the percutaneous medical device 110 to the body mount 112.

[0095] The body mount 112 further includes at least one magnetic trigger element 178. As an example, the magnetic trigger element may include a toroidal permanent magnet. When the percutaneous medical device 110 is attached to the body mount 112, the magnetic trigger element 178 is configured and oriented such that an external magnetic force is applied to the percutaneous medical device 110, specifically to the magnetic drive element 138. Specifically, the external magnetic force is oriented such that the magnetic trigger element 178 attracts the magnetic drive element 138 of the percutaneous medical device 110, thereby moving the movable part 120 from the distal position 154 shown in FIG. 2 against the force of the return spring 146 to the proximal position 156, as shown in FIG. 3. Thus, generally, the magnetic fields generated by the magnetic drive element 138 and the magnetic trigger element 178 can be oriented in the same direction, at least as far as the part is parallel to the penetrating axis 172.

[0096] The percutaneous medical device 110 is configured to attach to a body mount 112. For this purpose, the body mount 112 may include at least one body mount engagement element 180, specifically configured to mechanically engage with a device engagement element 182 of the percutaneous medical device 110. In the embodiment shown in Figures 1 and 3, where the body mount 112 is illustrated, the body mount may simply have an upper circumferential edge (e.g., a circular edge) that can engage with a corresponding edge 184 of the fixation member 118. Thus, edge 184 may project onto the front plate 150 to form a reception portion sized to receive the outer edge of the annular magnet of the magnetic triggering element 178. Engagement elements 180, 182 may be configured to enable self-positioning or self-centering. Thus, as shown in Figures 2 and 3, the reception portion of the fixation member 118 may have a conical shape by providing an inclined circumferential inner wall.

[0097] As shown in Figures 2 and 3, in the unused state of the percutaneous medical device 110 (where the movable part 120 is in the distal position 154), the movable part 120 can protrude from the retaining member 118 on the distal side 186 opposite the application side 168. The protective device 116 may include a clamp 188 engaging with the movable part 120, such that the movable part 120 is held in place in the distal position 154 and cannot move to the proximal position. Therefore, unintended triggering of the percutaneous medical device 110 can be prevented, for example, during transport or storage.

[0098] For the assembly of the percutaneous medical device 110, in the embodiments of Figures 1 to 3, firstly, the return spring 146 can be placed in the fixed internal space 148 of the fixed member 118. Subsequently, the movable member 120 is placed into the fixed internal space 148. The movable member 120 itself can be assembled by receiving a magnetic drive element 138 in the movable member 120, for example by inserting the magnetic drive element 138 (e.g., a toroidal magnet) into the needle holder space 136 of the needle holder 134. The needle holder 134, in which the magnetic drive element 138 is inserted, can be inserted into a movable space 132, specifically by inserting the needle holder 134 (in which the magnetic drive element 138 is inserted) into the cup-shaped movable lower portion 122 of the movable member 120. Subsequently, the movable upper portion 124 of the movable component 120 can be coupled to the movable lower portion 122 of the movable component 120, for example, via a snap-fit ​​connector 126.

[0099] The application side 168 of the percutaneous medical device 110 can be closed and / or sealed before use. Thus, by way of example, the application side 168 may be wholly or partially covered with a removable liner or removable seal, which is not depicted in the figures, and may be removed before use.

[0100] In use, for example, the body mount 112 of the percutaneous medical kit 114 is placed on the desired portion of the user's body surface using adhesive 176. For this purpose, as an example, the removable liner can be removed from the body mount 112, specifically from the adhesive 176 on the application surface 174.

[0101] Subsequently, the percutaneous medical device 110 can be moved to the body mount 112. Specifically, during this approach, self-centering of the percutaneous medical device 110 relative to the body mount 112 can occur, such that (by way of example) the axis of rotation of the percutaneous medical device 110 (e.g., the penetrating axis 172) and the axis of rotation of the body mount 112 (e.g., the axis of rotation of the toroidal magnet) are aligned, specifically automatically.

[0102] Furthermore, during approach and attachment of the percutaneous medical device 110 to the body mount 112, the percutaneous medical device 110 is magnetically triggered. This is due to the fact that the magnetic triggering element 178 of the body mount 112 applies an attractive external magnetic force to the magnetic drive element 138 of the percutaneous medical device 110. Consequently, the movable part 120 of the percutaneous medical device is pulled from the distal position 154 into the proximal position 156, resisting the force of the return spring 146 compressed during this triggering process. Thus, the penetrating element 140 is exposed from the opening 170, penetrating the user's skin and entering the user's body tissue at a well-defined puncture depth, which is primarily defined by the geometric protrusions of the penetrating element 140 on the application surface 174 in FIG. 3. Ideally, this process does not require the application of any pressure to the user's skin, thus avoiding compression of the skin and body tissue.

[0103] After penetration, bodily fluids (such as capillary blood) can enter the hollow lumen of the penetration element 140 (such as a hollow needle or capillary). From there, a sample of the bodily fluid can enter the sampling element 144, such as the lumen of a tube.

[0104] After successful sampling, the percutaneous medical device 110 can be detached from the body mount 112. This detachment can be easily achieved by removing the medical device 110 from the body surface in the axial direction. During this removal, the external magnetic force applied to the magnetic drive element 138 by the magnetic trigger element 178 is continuously reduced, and the spring force of the return spring 146 pushes the movable part 120 back to the distal position 154, thereby further removing the penetrating element 140 from the body tissue back into the fixed internal space 148 of the percutaneous medical device 110.

[0105] As illustrated in the exemplary embodiment, the percutaneous medical kit 114 provides automatic triggering during attachment of the percutaneous medical device 110 to the body mount 112. Furthermore, as discussed above, precise positioning of the incision side is possible, primarily due to self-positioning or self-centering. Furthermore, precise control of the penetration depth or puncture depth is feasible. The size and weight of the percutaneous medical kit 114 can be adapted to practical needs.

[0106] The percutaneous medical kit 114 shown in Figures 1 to 4 can be varied and modified in various ways. Thus, as an example, the internal structure and components of the fixing member 118 and the movable member 120 can be varied. Furthermore, the attachment and / or integration of the magnetic drive element 138 can also deviate from the illustrated embodiment. Furthermore, the sampling element 144 can also deviate from the illustrated embodiment, as can the purpose of the percutaneous medical kit 114 and the percutaneous medical device 110. As an example, the percutaneous medical kit 114 can also be used for injection purposes, as discussed above, in addition to or as an alternative to sampling bodily fluids. Finally, embodiments of the retraction spring 146 and the engagement elements 180, 182 can also be varied. These are merely some examples of possible modifications to the body mount 112 at the percutaneous medical device 110 and the percutaneous medical kit 114, all of which are feasible within the scope of the invention.

[0107] Figure 5 presents a general flowchart of a method for driving at least one penetrating element 140. As an example, this method can be applied to the embodiments shown in Figures 1 through 4. However, other embodiments are also possible. The method includes the steps shown in Figure 5, which can specifically be performed in a given order. However, different orders are also possible. Further, two or more, or even all, of the method steps can be performed consecutively, overlapping in time, or even simultaneously. Further, one or more, or even all, of the method steps can be performed once or multiple times. The method may contain additional method steps not listed.

[0108] The method includes the following steps: a. (Indicated by reference numeral 190) A percutaneous medical device 110 is provided, the percutaneous medical device 110 including at least one fixation member 118 and at least one movable member 120, wherein the movable member 120 is mounted to the fixation member 118 in a movable manner relative to the fixation member 118, wherein the movable member 120 is movable from a distal position 154 to a proximal position 156, wherein the fixation member 118 includes an application side 168, wherein the movable member 120 includes at least one penetrating element 140 configured to penetrate the user's skin, wherein the penetrating element 140 is received within the fixation member 118 at the distal position 154 of the movable member 120, and wherein the penetrating element 140 protrudes from the application side 168 of the fixation member 120 at the proximal position 156 of the movable member 120, wherein the movable member 120 further includes at least one magnetic actuating element 138, wherein the magnetic actuating element 138 is configured such that the movable member 120 The movement can be driven by at least one external magnetic force; b. (Indicated by reference numeral 192) A body mount 112 is provided, the body mount being configured to attach a percutaneous medical device 110 to a user's body surface, wherein the body mount 112 includes at least one application surface 174 for application to the body surface, wherein the body mount 112 further includes, on the side opposite to the application surface, at least one body mount engagement element 180 for engagement with the percutaneous medical device 110, specifically engaging with at least one device engagement element 182 of the percutaneous medical device 110, and wherein the body mount 112 further includes at least one magnetic triggering element 178; c. (Indicated by reference numeral 194) Attach the body mount 112 to the user's skin; and d. (Indicated by reference numeral 196) The percutaneous medical device 110 is attached to the body mount 112, wherein the percutaneous medical device 110 is engaged with the body mount engagement element 180, wherein the magnetic trigger element 178 of the body mount 112 applies an external magnetic force to the percutaneous medical device 110, specifically applying an external magnetic force to the magnetic drive element 138 of the percutaneous medical device 110, thereby magnetically attracting the magnetic drive element 138 of the percutaneous medical device 110.

[0109] List of reference numerals

Claims

1. A percutaneous medical device (110) comprising at least one fixed member (118) and at least one movable member (120), wherein the movable member (120) is mounted to the fixed member (118) in a movable manner relative to the fixed member (118), wherein the movable member (120) is movable from a distal position (154) to a proximal position (156), wherein the fixed member (118) includes an application side (168), wherein the movable member (120) includes at least one penetrating element (140) configured to penetrate a user's skin, wherein the penetrating element (140) is received within the fixed member (118) at the distal position (154) of the movable member (120), and wherein the penetrating element (140) is located at the proximal position (156) of the movable member (120) from the application side (168) of the fixed member (118). Highlighting this, the movable component (120) further includes at least one magnetic drive element (138), wherein the magnetic drive element (138) is configured such that movement of the movable component (120) can be driven by at least one external magnetic force.

2. The percutaneous medical device (110) according to the preceding claim, wherein the fixing member (118) includes a cannula, and wherein the movable member (120) is slidably received within the cannula.

3. The percutaneous medical device (110) according to any one of the preceding claims, wherein the magnetic drive element (138) comprises a permanent magnet.

4. The percutaneous medical device (110) according to any one of the preceding claims, further comprising at least one retraction spring (146) configured to apply a spring force to the movable member (120), the spring force being configured to move the movable member (120) from the proximal position (156) to the distal position (154).

5. The percutaneous medical device (110) according to any one of the preceding claims, wherein the fixation member (118) includes at least one stop (162, 164) defining at least one of the distal position (154) and the proximal position (156).

6. The percutaneous medical device (110) according to any one of the preceding claims, wherein the percutaneous medical device (110) is configured for sampling bodily fluids, wherein the percutaneous medical device (110) further comprises at least one sampling element (144), wherein the sampling element (144) is configured to receive at least one sample of the bodily fluids from an incision created by the penetrating element (140) in the user's skin.

7. The percutaneous medical device (110) according to any one of the preceding claims, wherein the percutaneous medical device (110) is configured to inject at least one medically active ingredient into the user's body tissue.

8. The percutaneous medical device (110) according to any one of the preceding claims, wherein the percutaneous medical device (110) includes at least one device engagement element (182) on the application side (168) for engaging with a body mount engagement element (180) of a body mount (112) attached to the body surface of the user.

9. A body mount (112) for attaching a percutaneous medical device (110) according to any one of the preceding claims to a user's body surface, wherein the body mount (112) includes at least one application surface (174) for application to the body surface, wherein the body mount (112) further includes at least one body mount engagement element (180) for engaging with the percutaneous medical device (110) on a side opposite to the application surface (174), and wherein the body mount (112) further includes at least one magnetic trigger element (178) configured to apply an external magnetic force to the percutaneous medical device (110) to magnetically attract the magnetic drive element (138) of the percutaneous medical device (110) when the percutaneous medical device (110) is attached to the body mount (112).

10. The body mount (112) according to the preceding claim, further comprising at least one adhesive element (176) for attaching the application surface (174) to the user's body surface.

11. The body mount (112) according to any of the preceding claims relating to the body mount (112), wherein the magnetic triggering element (178) comprises at least one permanent magnet.

12. A percutaneous medical kit (114) comprising at least one percutaneous medical device (110) according to any of the preceding claims relating to a percutaneous medical device (110), and further comprising at least one body mount (112) according to any of the preceding claims relating to a body mount (112).

13. The percutaneous medical device (114) according to the preceding claims, wherein the device engagement element (182) and the body mount engagement element (180) are configured to interact such that the percutaneous medical device (110) is aligned when attached to the body mount.

14. The percutaneous medical kit (114) according to any of the preceding claims relating to the percutaneous medical kit (114), wherein the magnetic trigger element (178) and the magnetic drive element (138) are configured such that when the body mount engagement element (180) is fully engaged with the percutaneous medical device (110), the penetrating movement of the movable part (120) is triggered by the magnetic trigger element (178).

15. A method of driving at least one penetrating element (140), the method comprising: a. A percutaneous medical device (110) is provided, the percutaneous medical device (110) comprising at least one fixed member (118) and at least one movable member (120), wherein the movable member (120) is mounted to the fixed member (118) in a movable manner relative to the fixed member (118), wherein the movable member (120) is movable from a distal position (154) to a proximal position (156), wherein the fixed member (118) includes an application side (168), wherein the movable member (120) includes the at least one penetrating element (140) configured to penetrate a user's skin, wherein the penetrating element (140) is received within the fixed member (118) at the distal position (154) of the movable member (120), and wherein the penetrating element (140) is displaced from the fixed member (118) at the proximal position (156) of the movable member (120). The application side (168) protrudes, wherein the movable part (120) further includes at least one magnetic drive element (138), wherein the magnetic drive element (138) is configured such that the movement of the movable part (120) can be driven by at least one external magnetic force. b. A body mount (112) is provided, the body mount being configured to attach the percutaneous medical device (110) to a user's body surface, wherein the body mount (112) includes at least one application surface (174) for application to the body surface, wherein the body mount (112) further includes at least one body mount engagement element (180) for engagement with the percutaneous medical device (110) on a side opposite to the application surface (174), and wherein the body mount (112) further includes at least one magnetic triggering element (178); c. Attach the body mount (112) to the user's skin; and d. Attach the percutaneous medical device (110) to the body mount (112), wherein the percutaneous medical device (110) engages with the body mount engagement element (180), wherein the magnetic trigger element (178) of the body mount (112) applies an external magnetic force to the percutaneous medical device (110), thereby magnetically attracting the magnetic drive element (138) of the percutaneous medical device (110).

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