Medical device for percutaneously inserting a cannula into body tissue - Patents.com

Abstract

To provide a medial device for percutaneously inserting a cannula in body tissues, a medicine device for delivering at least one medicine to a user, and a method for percutaneously inserting the cannula in body tissues.SOLUTION: A medical device 116 includes at least one cannula 145 provided with a lumen completely or partially surrounded by a wall 211 of the cannula and at least one patch 138 which is configured to be attached to the user's skin, the patch being provided with at least one patch base 140 and at least one insertion mechanism 144 integrated to drive the cannula from a storage position in the patch to an insertion position 218 in a body tissue. The patch is further provided with at least one reservoir 146 configured to store at least one medical fluid for treatment. The integrated insertion mechanism is a spring driven insertion mechanism 148.SELECTED DRAWING: Figure 3F

Description

[Technical field]

[0001] The present invention relates to a medical device for percutaneously inserting a cannula into body tissue, a drug device for delivering at least one drug to a user, and a method for percutaneously inserting a cannula into body tissue. The method and device according to the present invention can be mainly used for delivering insulin to a user. The present invention can be applied in the field of home care, but also in the field of professional care, such as in hospitals. Other applications are generally possible. [Background technology]

[0002] The delivery of medications, and in particular the delivery of insulin, to a user plays an important role in the prevention and treatment of diseases, and in particular the treatment of diabetes mellitus. In addition to using injection pens or syringes, insulin delivery can be performed, among others, by using insulin pumps.

[0003] In particular, a user generally needs to wear the insulin pump on his / her body at all times, thus leading to a preferably small and compact structure of the insulin pump and its components. A typical pump for delivering a drug, such as insulin, comprises multiple drug reservoirs. As an example, a fluid delivery device is disclosed in WO 2011 / 046950. The fluid delivery device comprises a housing having a fluid reservoir. A needle is in fluid communication with the fluid reservoir in an engaged position and is not in fluid communication with the fluid reservoir in a supply and storage position. A proximal end of a biasing member is coupled to the housing, and a distal end of the biasing member is configured to deliver a force to the fluid reservoir. A piston member extends through the biasing member and is coupled to the distal end of the biasing member. The piston member is fixed relative to the housing in a locked position such that the biasing member does not deliver a force to the fluid reservoir, and the piston member is movable relative to the housing in a released position such that the biasing member delivers a force to the fluid reservoir. Transitioning the needle from the stored position to the dispensing position transitions the piston from the locked position to the released position.

[0004] WO 2005 / 002649 describes a medical device comprising a transdermal device adapted for application to a skin surface of a user and supplied in a sterile state. Thus, a medical device is provided comprising an attachment surface adapted for application to the skin of a subject, a first portion having a first end adapted to penetrate the skin of the subject, and a second portion in fluid communication with the first portion and having a second end. The device further comprises enclosure means convertible from an initial configuration encapsulating the first and second portions in an initial sterile state to a second configuration allowing the ends of the first and second portions to communicate with the outside via the enclosure means, the enclosure means not enclosing the attachment surface.

[0005] WO 2017 / 220681 (Patent Document 3) discloses a medical device for percutaneously inserting an insertable element into body tissue. The medical device comprises at least one insertable element, the insertable element having at least one internal distal end for subcutaneous insertion and at least one external proximal end, and at least one insertion cannula for subcutaneously inserting the insertable element, the insertion cannula having a lumen completely or partially surrounded by a wall of the insertion cannula, the insertable element being received within the lumen, the insertion cannula being a pre-bent insertion cannula. The medical device further comprises at least one patch configured to be attached to the skin of a user. The patch comprises a patch base. The patch comprises an integrated insertion mechanism for driving the insertion cannula from a storage position within the patch to an insertion position within the body tissue on a curved insertion path.

[0006] Despite the advantages of state-of-the-art pumps for delivering insulin, some technical challenges remain. Generally, the cannula is inserted through a separate insertion unit or through an electric machine located in the patch. However, due to the external insertion unit, there is an external interface and additional processing steps are required. If an electric machine is applied, the manufacturing effort increases, leading to increased costs. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] International Publication No. 2011 / 046950 [Patent Document 2] International Publication No. 2005 / 002649 [Patent Document 3] International Publication No. 2017 / 220681 Summary of the Invention [Problem to be solved by the invention]

[0008] It is therefore an object of the present invention to provide a medical device for percutaneously inserting a cannula into body tissue, a drug device for delivering at least one drug to a user, and a method for percutaneously inserting a cannula into body tissue, which at least partially avoid the drawbacks of known devices and methods of this type and at least partially address the above-mentioned problems. In particular, a device and a method should be disclosed that allow an easy manufacturing and a simple handling process by the user. [Means for solving the problem]

[0009] This problem is addressed by a medical device for percutaneously inserting a cannula into body tissue, a drug device for delivering at least one drug to a user and a method for percutaneously inserting a cannula into body tissue, comprising the features of the independent claims. Advantageous embodiments, which can be realised alone or in any combination, are set out in the dependent claims.

[0010] As used below, the terms "having", "comprises" or "including" or any grammatical variants thereof are used in a non-exclusive manner. Thus, these terms may refer both to the situation where, in addition to the features introduced by these terms, no further features are present in the entity described in this context, and to the situation where one or more additional features are present. As an example, the expressions "A has B", "A comprises B" and "A includes B" may both refer to the situation where, apart from B, no other elements are present in A (i.e., A consists solely and exclusively of B), and to the situation where, apart from B, one or more further elements are present in entity A, such as element C, elements C and D, and even further elements.

[0011] Furthermore, it should be noted that the terms "at least one," "one or more," or similar expressions indicating that a feature or element may be present more than once are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may be present one or more than once.

[0012] Furthermore, as used below, the terms "preferably", "more preferably", "particularly", "more particularly", "particularly", "more particularly" or similar terms are used in conjunction with any feature without limiting the possibility of alternatives. Thus, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The present invention can be practiced by using alternative features, as those skilled in the art will recognize. Similarly, the terms "in an embodiment of the present invention" or similar terms may be used in conjunction with any feature without limiting the possibility of alternatives. Features introduced by expression are intended to be optional features without any limitations regarding alternative embodiments of the invention, without any limitations regarding the scope of the invention, and without any limitations regarding the possibility of combining the features introduced in such a way with other optional or non-optional features of the invention.

[0013] The terms "patient" and "user" as used herein are broad terms and should be given their ordinary and customary meaning to those skilled in the art and should not be limited to any special or customized meaning. The terms can specifically refer to, but are not limited to, a human or animal, regardless of the fact that the human or animal, respectively, may be in a healthy state or may be suffering from one or more diseases. As an example, a patient or user can be a human or animal suffering from diabetes. However, additionally or alternatively, the present invention can be applied to other types of users or patients or diseases.

[0014] The term "body tissue" as used herein is a broad term and should be given its normal and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, an intermediate cellular organization level between cellular and complete origin. A body tissue can specifically be a collection of similar cells from the same origin that together perform a specific function. An organ can then be formed by the combined functional grouping of multiple tissues. An example of a body tissue can be interstitial tissue, i.e., connective tissue between cellular elements in the case of a structure.

[0015] In a first aspect of the present invention, a medical device for percutaneously inserting a cannula into body tissue is disclosed. The medical device comprises at least one cannula. The cannula comprises a lumen that is completely or partially surrounded by a wall of the cannula. Furthermore, the medical device comprises at least one patch configured to be attached to the skin of a user. The patch comprises at least one patch base. The patch further comprises at least one integrated insertion mechanism for driving the cannula from a storage position in the patch to an insertion position in the body tissue. The patch further comprises at least one reservoir configured to store at least one therapeutic medical fluid. Furthermore, the integrated insertion mechanism is a spring-driven insertion mechanism.

[0016] The term "medical device" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, any device configured to perform at least one medical procedure. Thus, a medical device can generally be any device configured to perform at least one therapeutic purpose. A medical device can specifically comprise one component or an assembly of two or more components that can interact with each other, such as to perform a medical procedure, such as to perform one or more therapeutic purposes. A medical device can also generally be or comprise at least one of a medical system or a medical kit. A medical device can generally be used to deliver at least one agent, such as a drug and / or a therapeutic agent, to a user. Thus, a medical device can be used as part of one or more medical procedures.

[0017] The medical device may specifically be a disposable medical device. The term "disposable" as used herein is a broad term and should be given its ordinary and accustomed meaning to those skilled in the art and should not be limited to a special or customized meaning. The term specifically refers to, but is not limited to, components or elements that are discarded after use. Disposable elements or components can refer to properties of the material. Thus, the disposable elements or components can be designed to be irreversibly altered or even destroyed during use, such as by mechanical deformation or irreversible separation of components of the disposable element. Thus, the disposable elements can be configured to be discarded after use. Thus, the components can be made of at least one material that can be particularly low-cost and / or easily recyclable. Additionally, other embodiments are possible.

[0018] The medical device may be provided in a sterile package prior to use. The term "packaging" may refer to any object configured to fully or partially enclose or encase at least one other component, which may be a component requiring protection, such as mechanical protection and / or protection against moisture and / or microbial contamination, by way of example. The term "sterile" may generally refer to the property of any object being at least largely free of all forms of life and / or other biological agents, such as prions, viruses, fungi, bacteria or spore forms. Thus, a sterile object may be processed by at least one aseptic process that reduces, eliminates or inactivates forms of life and / or other biological agents.

[0019] The term "percutaneous" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically, but not limited to, refer to the property of any element adapted to be placed completely or at least partially through the body tissue of a patient or user. To this end, the element can be provided with an insertable portion. To further render the element usable as a percutaneous element, the element can be provided completely or partially with a biocompatible surface, i.e., a surface that does not have a detrimental effect on the user, patient or body tissue, at least during the period of use. Furthermore, the percutaneous element can be dimensioned such that percutaneous insertion of the element into the body tissue is feasible, such as by providing a width in a direction perpendicular to the insertion direction of generally 5 mm or less, preferably 2 mm or less, more preferably 1.5 mm or less. Thus, the term "subcutaneous" can generally refer to the property of any element located or lying below the skin and within the body tissue of a user or patient. Specifically, the subject can be configured to be introduced below the skin, for example as an injection.

[0020] The term "cannula" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, any element that can be at least partially insertable into any body tissue, especially for delivering or transporting further elements. Thus, a cannula can specifically be or comprise a hollow tube or a hollow needle.

[0021] As mentioned above, a cannula has a lumen that is completely or partially surrounded by the walls of the cannula. The term "lumen" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, the interior volume of any element. The interior volume can specifically be an open interior volume. Thus, the interior volume can be completely or unenclosed by the walls of the element. Instead, it can allow the flow of a fluid medium or the insertion of another object from one end of the element to another end through the lumen.

[0022] The term "wall" as used herein is a broad term and will be understood by those skilled in the art according to their ordinary usage. The term should be given its conventional meaning and should not be limited to a special or customized meaning. The term can specifically, but not limited to, refer to any structure, specifically a structural material configured to at least partially enclose another object or volume, thereby defining the physical limits of the object. Additionally, a wall can be configured to protect the volume or other object at least partially enclosed by the wall.

[0023] Specifically, the cannula may be selected from the group consisting of: a closed cannula whose wall circumferentially surrounds the lumen. The term "circumferentially surround" may generally refer to a property of any object or volume that is completely surrounded by another object in at least two dimensions. Specifically, the lumen of the cannula may be completely surrounded by the cannula in a direction perpendicular to the direction of elongation of the cannula.

[0024] The cannula may be selected from the group consisting of: an insertion cannula for inserting an infusion cannula; an infusion cannula. The term "infusion cannula" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any cannula configured for infusion, i.e., for introducing a liquid substance, specifically a liquid substance including a drug, directly into a body tissue, typically into a patient's vein. Thus, the infusion cannula may be attached to a reservoir containing a liquid substance, particularly via the extracorporeal proximal end of the infusion cannula. The infusion cannula may be part of an infusion kit. The term "infusion kit" may refer to an assembly of components necessary for the performance of any infusion. Thus, in addition to the infusion cannula, the infusion kit may further comprise at least one fluid coupling for coupling the infusion kit to at least one drug device, preferably at least one drug pump.

[0025] Alternatively, the cannula may be an insertion cannula for inserting an intravenous cannula. The insertion cannula may specifically be an injection needle. The injection needle may be disposed within the lumen of the soft cannula, and the injection needle may be removed after insertion of the soft cannula, e.g., the soft cannula is configured to remain at least partially within the body tissue and remain within the body tissue for the useful life of the medical device. The term "soft cannula" may refer to any cannula that is at least partially made from at least one soft material, e.g., an elastic material. The elastic material may specifically comprise at least one elastic material. Thus, the soft cannula may be or may comprise a flexible tube. Meanwhile, the injection needle may remain outside the body tissue, but may be incorporated within the medical device. Specifically, the injection needle may be protectively surrounded by the medical device such that the injection needle does not cause a risk to the user or patient. Thus, the user or patient may have an injection needle attached to the body tissue via the medical device and protectively surrounded by the medical device, specifically by the housing of the medical device. Thus, the injection needle and the soft cannula can be configured to be removed from the patient's body simultaneously after the effective life of the medical device has expired.

[0026] The cannula can be made at least in part from at least one biocompatible material, i.e. a surface that does not have a detrimental effect on the user, the patient, or the body tissues, at least during the period of use. The cannula, in particular the infusion cannula, can be made at least in part from steel, in particular stainless steel. Steel, in particular stainless steel, can be biocompatible. Furthermore, the application of steel, in particular stainless steel, can provide a rigid infusion cannula. However, other materials, such as plastic materials, can also be possible.

[0027] The cannula may be a pre-bent cannula. The term "pre-bent" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but not limited to, refer to a geometric characteristic of an element that is at least partially non-linear in shape, at least in the absence of external forces. Thus, the insertion cannula may be at least partially non-linear in shape, at least in the absence of external forces. Thus, the cannula may specifically, be embodied as having a fully or partially non-linear phrase, specifically, having a fully or partially curved shape. Specifically, the cannula may be embodied as having a fully or partially circle segment shape. Thus, specifically, the cannula may be pre-bent such that it has a fully or partially circle segment shape. More specifically, as an example, the pre-bent cannula may be a steel cannula, specifically a stainless steel cannula, that is pre-bent to be fully or partially curved, specifically, to have a circle segment shape.

[0028] The cannula may include at least one curvature, whereby a portion of the cannula, such as an end of the cannula, may be disposed at an angle relative to the main axis. In particular, the cannula may have an angle of 30° to 60°, preferably 40° to 45°, more preferably 45°, relative to the main axis. In particular, the second configuration may correspond to an arched shape of the cannula. The arched shape may in particular refer to the state of the cannula, whereby the cannula may be curved such that a portion of the cannula, in particular an end of the cannula, more particularly the end of the cannula including the intracorporeal distal end of the insertable element, protrudes from the main axis. The curvature may in particular be, at least in the main axis, unbent.

[0029] The infusion cannula can be configured to be removed from the body tissue after expiration of the useful life of the medical device. The term "useful life" can refer to the period during which any device can be applied in the intended manner. Specifically, the medical device can be configured to remain attached to the patient's or user's skin for several days, for example, 2 to 4 days. During this period, the medical device can be configured to transfer the infusion to the body tissue, as further described below. Additionally, during this period, the cannula can remain within the body tissue.

[0030] The term "patch" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically, but is not limited to, refer to a device that can be attached to the skin or skin site of a user or patient. Thus, a patch can include at least one adhesive surface and / or at least one attachment component that can connect a body mount to the skin, such as at least one adhesive strip or bandage. Thus, the term "attachment" can specifically, but is not limited to, refer to any process of fastening or attaching an element to an object. The attachment can be a permanent attachment, e.g., the element and the object can have a permanent connection to each other that can not be broken when the unit of the element and the object is bent or when mechanical stress is applied to the element and / or the object.

[0031] As outlined above, the patch comprises a patch base. As further used herein, the term "base" refers to any support of an object on which further components of the object are placed. The term "body mount" refers to a patch base that includes a base that is configured to support the body tissue of the patient or user. The base may include a support surface providing a bearing area for the further component. In particular, the patch base may be a flat element. The patch base may include a bottom surface that faces the body tissue of the user or patient. The bottom surface may be an adhesive surface as described above. Furthermore, the patch base may include a top surface. The top surface may be configured as a bearing surface and may be configured to host the further component of the medical device. Thus, the patch may also be referred to as a body mount. The patch base may include at least one passage opening. The cannula may be movable from the patch through the passage opening to the body tissue. The shape of the passage opening may correspond to the shape of the cannula.

[0032] The term "reservoir" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to a hollow element or container that can be filled completely or partially with a fluid, such as, but not limited to, a drug and / or therapeutic agent. Specifically, the reservoir can be filled with insulin. The reservoir can be removably positionable within the medical device. Specifically, the insertion cannula can be an infusion cannula as described above, and the reservoir can be configured to release a therapeutic medical fluid through the cannula. The reservoir can comprise at least one cartridge or vial. The vial can have a cylindrical shape. The reservoir can be a vial, specifically a rigid vial.

[0033] The medical device may further comprise at least one further reservoir configured to store and release at least one further therapeutic medical fluid. The reservoir and the further reservoir may be arranged adjacent to each other. Thus, the reservoir and the further reservoir may be arranged in a space-saving manner. The medical device may further comprise at least one mixing device. The mixing device may comprise at least one static mixer. The mixing device may be configured to mix the therapeutic medical fluid of the reservoir with the further therapeutic medical fluid of the further reservoir such that a mixture is formed before the mixture is applied to the user via the cannula.

[0034] The medical device may further comprise at least one piston, specifically at least one piston rod. The piston may be configured to displace the therapeutic medical fluid of the reservoir. The term "piston" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but is not limited to, refer to any moving component contained in a cylinder and made at least in large part air-tight and / or water-tight by piston rings. In a pump, the piston may be configured to transmit force from a crankshaft to a cylinder for the purpose of compressing or expelling a fluid in the cylinder. The term "displacement" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically, but is not limited to, refer to a process of reducing the free volume of a defined interior space. Thus, by reducing the free volume, a portion of the fluid received within the defined interior space may leave the interior space, e.g., the fluid may be expelled from the interior volume.

[0035] The medical device may further include at least one drive spindle. The drive spindle may be operably connectable to at least one drug pump. As used herein, the term "drive spindle" is a broad term and is readily understood by those skilled in the art. The term should be given its ordinary and customary meaning and should not be limited to a special or customized meaning. The term can specifically, but not limited to, refer to any rotatable shaft configured to urge another element in a desired direction, preferably by pushing or pulling the other element. Specifically, the drive spindle can be configured to linearly push or pull the other element. As mentioned above, the medical device can include at least one piston. The drug pump can be configured to move the piston via the drive spindle. Thus, by rotating the drive spindle, the piston can displace the therapeutic fluid in the reservoir.

[0036] The term "insertion mechanism" may generally refer to an assembly of components configured to interact with each other for the purpose of inserting the element at least partially into another object. The insertion mechanism may thus be configured to introduce a movement of the element in the insertion direction, i.e., toward the surface of the other object. The insertion mechanism may be an integrated insertion mechanism. The term "integrated insertion mechanism" may refer to an assembly of components configured to interact with each other for the purpose of inserting the element at least partially into another object, the assembly of components being provided as one unit, as a whole and / or as an "all-in-one" system. Thus, a user may find a medical device with a fully assembled insertion mechanism without the need to add other components to the medical device or to apply further devices in addition to the medical device for the purpose of inserting the cannula into the body tissue. Furthermore, if necessary, the integrated insertion mechanism may also be configured to subsequently return the cannula from the insertion position to the storage position. However, the medical device may also be configured to remove the medical device from the body tissue while the cannula is in the insertion position, as will be explained in more detail below.

[0037] The term "storage position" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically, but is not limited to, a position of the cannula in the patch where the cannula does not protrude into body tissue. Specifically, the cannula can be fully or partially surrounded by the patch. The term "insertion position" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically, but is not limited to, a position of the cannula where the cannula protrudes fully or partially from the patch, such as by protruding fully or partially into body tissue, such that preferably the proximal end of the cannula is fully or partially held by or connected to the patch. In the storage position and the insertion position, the cannula may have the same shape or different shapes. Illustratively, the cannula can have the same bend radius or the same shape in the storage position.

[0038] The integrated insertion mechanism can be configured to drive the cannula into the body tissue of the user or patient on a curved path. The term "on a curved path" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, the fact that the tip of the cannula follows a path that is at least partially non-linear during movement from the storage position to the insertion position. Specifically, the path can have the shape of at least partially a segment of a circle.

[0039] The term "spring actuated insertion mechanism" as used herein is a broad term and should be given its ordinary and accustomed meaning to those of ordinary skill in the art and should not be limited to any special or customized meaning. The term specifically refers to, but is not limited to, the elements It can refer to any insertion mechanism in which the interaction of an assembly of components for at least partial insertion into another object is driven or triggered by a spring element. Thus, the force can be generated by a spring, in particular by a force that is released when a tensioned spring is released from a tensioned position. As a result, by releasing the spring from a tensioned position, the cannula can be biased in the insertion direction, preferably by pushing or pulling the cannula.

[0040] The integrated insertion mechanism, particularly the spring-driven insertion mechanism, can be a manual insertion mechanism. The term "manual insertion mechanism" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, any insertion mechanism in which the insertion mechanism is triggered or executed simply by applying a mechanical force. The mechanical force, e.g., tension of a spring element as described above or in more detail below, can be generated by a manual procedure of a user or patient, as described in more detail below. Thus, the integrated insertion mechanism can be triggerable without the need for an electrical energy source. The medical device, particularly the patch base, can be connectable to at least one external element that interacts with the cannula. The integrated insertion mechanism can be configured to be driven by a force established when connecting the external element to the medical device.

[0041] The integrated insertion mechanism may comprise at least one drive unit configured to bias the cannula in the insertion direction, preferably by pushing the cannula. The term "drive unit" as used herein is a broad term and should be given its ordinary and customary meaning to the skilled artisan and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, an element or an assembly of elements configured to interact with each other to generate a force that directs the movement of another element, specifically a predetermined movement. Specifically, the drive unit may be configured to bias the cannula in the insertion direction, preferably by pushing or pulling the cannula. Specifically, the drive unit may be configured to move in the extension direction of the reservoir. Thus, the drive unit may at least partially surround the reservoir and may be configured to move along the reservoir.

[0042] The integrated insertion mechanism can be a sliding mechanism, preferably a linear sliding mechanism. The term "sliding mechanism" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically, but not exclusively, refer to any mechanism based on a linear sliding movement of two or more components relative to each other. Thereby, the term "sliding movement" can refer to a movement along a continuous connection with another element, in particular a surface of the other element, more specifically a smooth surface. In particular, the linear sliding mechanism can comprise one or more interacting sliding elements, such as one or more guide rails. Furthermore, the term "linear sliding movement" can generally refer to a movement along a straight line, for example in two dimensions.

[0043] The integrated insertion mechanism may further comprise at least one spring element. The term "spring element" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any elastic object used to store mechanical energy. If the object may be coupled to a spring element, the spring element may be configured to be tensioned when the object is moved. The spring element can be configured to tension the cannula prior to insertion into the body tissue. The spring element can be configured to tension the cannula prior to insertion into the body tissue. The spring element can be configured to tension the cannula prior to insertion into the body tissue. The spring element can be configured to tension the cannula prior to insertion into the body tissue. The spring element can be configured to tension the cannula prior to insertion into the body tissue. The spring element can be configured to tension the cannula prior to insertion into the body tissue. The spring element can be configured to tension the cannula prior to insertion into the body tissue.

[0044] In particular, the spring element can be tensionable parallel to the insertion direction. The drive unit can be configured to compress the spring element, as described in more detail below. The spring element can thus be configured to relax in the insertion direction and thereby push the cannula in the insertion direction. In particular, the reservoir can be at least partially received in the spring element. Furthermore, the cannula can be at least partially received in the spring element. Thus, the components of the medical device can be arranged in a space-saving manner and the structural size of the medical device can be reduced. The spring element can be configured to at least largely prevent withdrawal of the cannula from the body tissue after insertion. Thus, in the insertion position, the cannula can be at least partially inserted into the body tissue. The spring element can be present in a relaxed state and thereby exert a force on the cannula in the insertion direction, in particular on the extracorporeal end of the cannula.

[0045] Additionally, the medical device can include decoupling of the cannula movement. The spring element can be configured to be tensioned parallel to the insertion direction. Thus, the cannula can be flexible in the insertion direction.

[0046] The integrated insertion mechanism may further comprise at least one interlocking element configured to secure the drive unit in a fixed position. The term "interlocking element" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, holding or fixing an object in a particular position to prevent undesired movement or separation from another element, especially by applying inward pressure. The interlocking element may be fixedly connected to the drive unit.

[0047] The interlocking element may comprise at least one first interlocking element component and at least one second interlocking element component, the first interlocking element component and the second interlocking element component being at least partially made from an elastic material, and the first interlocking element component and the second interlocking element component being configured to form a mechanical connection, specifically a form-fit connection. The form-fit connection may be a releasable form-fit connection. The interlocking element may have a snap closure. The term "snap closure" may refer to any closure that engages via a snap or clip mechanism. The click mechanism may be a one-way clip mechanism.

[0048] The medical device may further comprise at least one elongate element. The elongate element may extend in a lateral direction, in particular perpendicular to the elongation direction of the cannula. The cannula, in particular at least one end of the cannula, may be fixedly received in a receptacle of the elongate element. The patch base may comprise a sliding guide receptacle, preferably a linear sliding guide receptacle. The linear sliding guide receptacle may be configured to at least partially receive a protrusion of the elongate element. The receptacle may in particular be a part of the protrusion. The protrusion may be configured to slide in the linear sliding guide receptacle. The linear sliding guide receptacle may extend in a lateral direction, in particular perpendicular to the elongation direction of the cannula. The reservoir may , can be connectable to the cannula via at least one flow channel. The flow channel can illustratively be a flexible tube. One end of the flow channel can be received in a protrusion of the elongate element. Further, the extracorporeal proximal end of the cannula can also be at least partially received within the protrusion of the elongate element. Thus, the protrusion can be configured to establish a fluid connection between the flow channel, e.g., a reservoir, and the cannula.

[0049] The interlocking element can be configured to surround the elongated element such that, prior to insertion, when the cannula is in the storage position, the interlocking element can be moved in a direction opposite to the insertion direction such that the interlocking element can be opened, thereby surrounding the elongated element and establishing a fixed connection therewith.

[0050] The integrated insertion mechanism may further comprise at least one release button. The release button may be an elongated element having a first end and a second end. The first end may have a receptacle. The receptacle may have a shape corresponding to the shape of the elongated element. Exemplarily, the elongated element may be a cylinder with a round cross section and the receptacle may have a correspondingly round shape. The second end of the release button may be located on the outside of the patch. Thus, the second end may be accessible to the user or patient. The release button may be configured to hold the elongated element in place and subsequently release the elongated element. The release button may be configured to be pressed, thereby triggering the integrated insertion mechanism. Thus, the integrated insertion mechanism may be manually triggerable. However, other embodiments may also be possible. Exemplarily, the integrated insertion mechanism may be triggered as soon as the medical device and the external element are assembled. Thereby, the medical device can be placed and fixedly applied to the skin site of the user prior to assembly of the medical device and the external element. However, other embodiments may be possible. The integrated insertion mechanism may also be a button-less integrated insertion mechanism. Exemplarily, the integrated insertion mechanism may be triggered as soon as the external element is connected to the medical device.

[0051] In a further aspect of the present invention, a drug device for delivering at least one therapeutic medical fluid to a user is disclosed. The drug device comprises at least one first part. The first part comprises at least one medical device, as described above or in further detail below. Furthermore, the drug device comprises at least one second part. The second part comprises at least one drug pump fluidly connectable to the cannula. Furthermore, the second part comprises at least one electronics unit. The drug device comprises at least one medical device, as described above or in further detail below.

[0052] The term "pharmaceutical device" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, any device configured to administer or deliver a drug and / or therapeutic agent via a particular route of administration. Such devices are typically used as part of one or more medical treatments. Specifically, the term "pharmaceutical device" can refer to a device for administering insulin by using at least one pump.

[0053] The terms "first" and "second" as generally used herein to denote a component or element may be considered only as a nomenclature, without numbering or ranking the named elements, without specifying an order, and without excluding the possibility that there may be several types of first and second parts. Furthermore, there may be additional parts, such as one or more third parts or elements. The term "part" may refer to any component of the object. A component may be configured to interact with another component of the object. In particular, the first and second parts of the drug device may interact with each other to perform one or more therapeutic purposes, such as to perform a medical procedure as outlined above. The first part may be a disposable component and the second part may be a reusable component. The second part and / or the first part may be a watertight component. In particular, the drug device may be a watertight drug device. To this end, the second part may have one or more sealing elements that may be configured to be pressed against at least one surface of the first component. Thus, the interior formed by the first and second parts may be surrounded watertight.

[0054] The term "drug pump" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to, but is not limited to, any pump configured to move a drug and / or therapeutic agent by mechanical action. Specifically, the drug pump can be an infusion pump configured to infuse any drug into the circulatory system of a patient. In general, the infusion pump can be configured to be applied intravenously or subcutaneously. However, other applications are possible. The drug pump can be a positive displacement pump. The positive displacement pump can be configured to move at least one piston of the medical device in the extension direction of the reservoir, particularly via at least one drive spindle of the medical device.

[0055] The term "fluidly coupled" or "fluidly connectable" may generally refer to a characteristic of two or more elements such that any fluid may be transferred between the two or more elements. The drug pump may specifically be an insulin pump. The term "insulin pump" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, an apparatus for administering insulin by using at least one pump. Thus, the term "fluidly connectable" may also be referred to as "operably connectable" as far as fluid operations are concerned.

[0056] The term "electronics unit" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. The term can specifically refer to any device having at least one electronic component, including but not limited to. Specifically, the electronics unit can include at least one electronic component for one or more of performing measurements with a sensor, performing voltage measurements, performing current measurements, recording a sensor signal, storing a measurement signal or measurement data, and transmitting a sensor signal or measurement data to another device. The electronics unit can specifically be embodied as or include a transmitter to transmit data. Other embodiments of the electronic components are also possible. The electronics unit can include at least one interconnect device, preferably a printed circuit board, more preferably a flexible printed circuit board. The electronics unit can be specifically configured to control and operate the drug pump. Furthermore, the second part can include at least one energy storage device. The energy storage device can be part of the electronics unit. The energy storage device can be selected from the group consisting of a battery, a rechargeable battery, and a storage battery. Other embodiments are also possible.

[0057] The first and second portions can be configured to establish at least one mechanical connection selected from the group consisting of a form-fit connection, a press-fit connection. When used herein, the term "mechanical connection" generally refers to a connection of two or more components by a mechanical holding force. As an example, the mechanical connection can be or include at least one of a form-fit or a force-fit connection. As further used herein, the term "releasable" in the context of a mechanical connection generally refers to the fact that the mechanical connection can be brought from a disconnected state, also referred to as a non-mated state, to a connected state, also referred to as a coupled state, and back to the disconnected state. Thus, the mechanical connection can be freely closed or released. Specifically, the mechanical connection can be releasable without the use of any tools, just by manual manipulation. As an example, a force of 50 N or less, e.g. 20 N or less, e.g. 10 N or less, that can be applied by one hand of a user or even by a finger or fingertip, can be required to open the connection between the first part and the second part.

[0058] Specifically, the first and second parts can be connectable via at least one linear slide mechanism. The first part can include at least one linear slide receptacle, and the second part can include at least one linear slide guide rail, or vice versa. The linear slide receptacle and the linear slide guide rail can together form a linear slide connector configured to establish a releasable mechanical connection between the first and second parts. As further used herein, the terms "linear slide receptacle" and "linear slide guide rail" can refer to elements that are complementary to each other and configured to interact with each other to realize a linear slide mechanism. Exemplarily, the linear slide guide rail can be formed as a protrusion of the first part, and the linear slide receptacle can be the second part, or vice versa. However, other embodiments can also be possible. The linear slide guide rail and the linear slide receptacle can be shaped complementary to each other. Exemplarily, the linear slide receptacle and the linear guide rail can have an elongated shape and can extend along the longitudinal axis of the first part and / or the second part. The linear slide receptacle and the linear slide guide rail can together form a linear slide connector configured to establish a releasable mechanical connection between the electronics unit and the patch. The term "linear slide connector", also referred to as linear slide connection, can generally refer to any connector or connection between two linear slide profiles. Therein, generally, one or both of the involved linear slide profiles can be provided with at least one protrusion, and in a complementary manner, the other of the linear slide profiles can be provided with at least one linear slide groove or linear slide slot in which the protrusion can be guided to form a linear slide connection or linear slide connector.

[0059] By connecting the first and second parts, the interlocking element can be moved in a direction opposite to the insertion direction such that the interlocking element can be opened, thereby surrounding the elongated element and establishing a fixed connection therewith.

[0060] In a further aspect of the invention, a method for percutaneously inserting a cannula into body tissue is disclosed. The method is as set forth in the independent claims and includes the method steps as described below. The method steps may be performed in the specified order. However, other orders of the method steps are possible. Furthermore, one or more of the method steps may be performed in parallel and / or overlapping in time. Furthermore, one or more of the method steps may be performed repeatedly. Furthermore, there may be additional method steps not listed.

[0061] The method includes the following steps: a) providing a pharmaceutical device as described above or in further detail below; And, b) placing the first portion on the user's skin; c) assembling the first part and the second part such that the first part and the second part establish at least one connection selected from the group consisting of a form-fit connection, a press-fit connection; d) Triggering an integrated insertion mechanism, thereby driving the cannula from a stored position within the patch to an insertion position within the body tissue.

[0062] Step b) can be performed before performing step c), or alternatively, step b) may be performed after performing step c).

[0063] The proposed medical devices, analyte measuring devices, pharmaceutical devices, and proposed methods for percutaneously inserting insertable elements into body tissue offer many advantages over known devices and methods.

[0064] Generally, the infusion cannula can be inserted through a separate insertion unit or through an electric machine disposed in the patch. However, due to the external insertion unit, there is an external interface and additional processing steps are required. If an electric machine is applied, the manufacturing labor is increased, leading to increased costs.

[0065] On the contrary, the medical device, pharmaceutical device and method according to the present invention allow for an easy manufacturing and simple handling process by the user, and furthermore, the need to utilize a separate insertion unit can be avoided, thus saving additional attachment elements and additional manufacturing processes.

[0066] The energy for inserting the cannula can be provided via an insertion mechanism integrated in the patch. An electric driver may not be necessary. The cannula can have an arch shape and can be placed in the patch in a space-saving manner. Furthermore, the cannula can be a guided cannula and require only a small opening in the patch base. Thus, the insertion of the cannula can be performed with little deformation of the user's or patient's tissue.

[0067] Furthermore, the spring element can be arranged within the patch in a space-saving manner: in particular, the reservoir can be arranged within the interior of the spring element or the cannula can be arranged within the interior of the spring element.

[0068] Furthermore, after insertion, the cannula can be centrally located under the patch, so that the cannula can move elastically during application of the medical device, which can result in improved wearing comfort.

[0069] The second part comprising the drug pump and electronics unit can act as a slider for tensioning the spring element, thereby reducing the handling effort for the user or patient.

[0070] The watertight design of the drug device eliminates the need to remove the drug device from the user's or patient's skin site for showering, bathing, swimming, etc. The second part can be reusable and the battery can be replaced by the user or patient himself. Alternatively, the second part can have a storage battery and the second part can have a cover for charging contacts. Additionally, inductive charging can be provided.

[0071] By applying multiple reservoirs, such as by applying two reservoirs, the medical device can be designed in a flat manner. Furthermore, by applying multiple reservoirs, multiple types of fluids can be applied.

[0072] In summary, without excluding further possible embodiments, the following embodiments can be envisaged:

[0073] Embodiment 1: A medical device for percutaneously inserting a cannula into body tissue, comprising: at least one cannula having a lumen completely or partially surrounded by a wall of the cannula; at least one patch configured to be attached to a user's skin, the patch comprising at least one patch base, the patch further comprising at least one integrated insertion mechanism for driving an insertion cannula from a stored position within the patch to an insertion position within body tissue; The medical device, wherein the patch further comprises at least one reservoir configured to store at least one therapeutic medical fluid, and the integrated insertion mechanism is a spring-driven insertion mechanism.

[0074] Embodiment 2: The medical device of the preceding embodiment, wherein the medical device is a disposable medical device.

[0075] Embodiment 3: A medical device according to any one of the preceding embodiments, wherein the integrated insertion mechanism is a sliding mechanism, preferably a linear sliding mechanism.

[0076] Embodiment 4: A medical device according to any one of the preceding embodiments, wherein the integrated insertion mechanism comprises at least one drive unit configured to urge the cannula in the insertion direction, preferably by pushing the cannula.

[0077] Embodiment 5: The medical device of the preceding embodiment, wherein the drive unit is configured to move in the extension direction of the reservoir.

[0078] Embodiment 6: A medical device described in any one of the previous two embodiments, wherein the drive unit at least partially surrounds the reservoir and is configured to move along the reservoir.

[0079] Embodiment 7: A medical device described in any one of the preceding three embodiments, wherein the medical device, specifically the patch base, is connectable to at least one external element and the integrated insertion mechanism is configured to be driven by a force established when connecting the external element to the medical device.

[0080] Embodiment 8: A medical device according to any one of the preceding four embodiments, wherein the integrated insertion mechanism further comprises at least one spring element.

[0081] Embodiment 9: The medical device of the preceding embodiment, wherein the spring is tensionable parallel to the insertion direction.

[0082] Embodiment 10: The medical device of the preceding embodiment, wherein the drive unit is configured to compress the spring element.

[0083] Embodiment 11: A method according to any of the preceding embodiments, in which the reservoir is at least partially received within the spring element. A medical device according to any one of the two embodiments.

[0084] Embodiment 12: A medical device described in any one of the preceding three embodiments, wherein the cannula is at least partially received within the spring element.

[0085] Embodiment 13: A medical device described in any one of the preceding four embodiments, wherein the spring element is configured to push the cannula in the insertion direction.

[0086] Embodiment 14: A medical device described in any one of the preceding five embodiments, wherein the spring element is configured to at least largely prevent withdrawal of the cannula from the body tissue after insertion.

[0087] Embodiment 15: A medical device described in any one of the preceding ten embodiments, wherein the integrated insertion mechanism further comprises at least one interlocking element configured to lock the drive unit in a fixed position.

[0088] Embodiment 16: The medical device of the preceding embodiment, wherein the interlock element is fixedly connected to the drive unit.

[0089] Embodiment 17: A medical device described in any one of the previous two embodiments, wherein the interlocking element has a snap closure.

[0090] Embodiment 18: The medical device of the preceding embodiment, wherein the interlocking element comprises at least one first interlocking element component and at least one second interlocking element component, the first interlocking element component and the second interlocking element component being at least partially made from an elastic material, and the first interlocking element component and the second interlocking element component being configured to form a mechanical connection, specifically a form-fit connection.

[0091] Embodiment 19: A medical device as described in the preceding embodiment, wherein the form-fit connection is a releasable form-fit connection.

[0092] Embodiment 20: A medical device described in any one of the preceding five embodiments, wherein the medical device further comprises at least one elongated element having at least one protrusion, the cannula, specifically at least one end of the cannula, being fixedly received within a receptacle of the protrusion, and the interlocking element is configured to surround the elongated element.

[0093] Embodiment 21: A medical device as described in the preceding embodiment, wherein the integrated insertion mechanism further comprises at least one release button, the release button configured to hold the elongated element in place and subsequently release the elongated element.

[0094] Embodiment 22: A medical device described in any one of the preceding two embodiments, wherein the patch base comprises a sliding guide rail, preferably a linear sliding guide rail, the linear sliding guide rail being configured to at least partially receive the protrusion, and the protrusion being configured to slide within the linear sliding guide rail.

[0095] Embodiment 23: A medical device according to any one of the preceding three embodiments, wherein a release button is configured to be pressed, thereby triggering an integrated insertion mechanism.

[0096] Embodiment 24: The interlocking element is a clip mechanism, specifically a one-way clip mechanism. 10. The medical device of any one of the preceding nine embodiments, comprising:

[0097] Embodiment 25: A medical device according to any one of the preceding embodiments, wherein the integrated insertion mechanism is manually triggerable.

[0098] Embodiment 26: A medical device described in any one of the preceding embodiments, wherein the medical device further comprises at least one piston, specifically at least one piston rod, the piston configured to displace the therapeutic medical fluid in the reservoir.

[0099] Embodiment 27: The medical device of the preceding embodiment, further comprising at least one drive spindle, the drive spindle being operably connectable to at least one drug pump, and the drug being configured to move the piston via the drive spindle.

[0100] Embodiment 28: A medical device according to any one of the preceding embodiments, wherein the reservoir is connectable to the cannula via at least one flow path.

[0101] Embodiment 29: The medical device of the preceding embodiment, wherein the flow path is a flexible tube.

[0102] Embodiment 30: A medical device according to any one of the preceding embodiments, wherein the reservoir is a vial, particularly a rigid vial.

[0103] Embodiment 31: The medical device of the preceding embodiment, wherein the vial has a cylindrical shape.

[0104] Embodiment 32: The medical device according to any one of the preceding embodiments, wherein the cannula is at least partially made of at least one material selected from the group consisting of steel, in particular stainless steel, and plastic materials.

[0105] Embodiment 33: A medical device according to any one of the preceding embodiments, wherein the cannula is a pre-bent cannula.

[0106] Embodiment 34: A medical device according to any one of the preceding embodiments, wherein the cannula is an infusion cannula and the reservoir is configured to release a therapeutic medical fluid through the cannula.

[0107] Embodiment 35: A medical device as described in the preceding embodiment, wherein the cannula is pre-bent such that the cannula has the shape of at least partially a segment of a circle.

[0108] Embodiment 36: A medical device according to any one of the preceding embodiments, wherein the cannula is made from at least one biocompatible material.

[0109] Embodiment 37: A medical device according to any one of the preceding embodiments, wherein the integrated insertion mechanism comprises at least one element configured to at least largely prevent withdrawal of the cannula from the body tissue after insertion.

[0110] Embodiment 38: A medical device described in any one of the preceding embodiments, wherein the integrated insertion mechanism is configured to drive the cannula from a storage position in the patch to an insertion position in the body tissue on a curved insertion path.

[0111] Embodiment 39: The insertion path is at least partially shaped as a segment of a circle. , The medical device of the preceding embodiment.

[0112] Embodiment 40: A medical device described in any one of the preceding embodiments, wherein the patch base has at least one passage opening, and the cannula is movable from the patch through the passage opening into the body tissue.

[0113] Embodiment 41: A medical device as described in the preceding embodiment, wherein the shape of the passage opening corresponds to the shape of the cannula.

[0114] Embodiment 42: A medical device according to any one of the preceding embodiments, wherein the medical device further comprises at least one additional reservoir configured to store and release at least one additional therapeutic medical fluid.

[0115] Embodiment 43: A medical device as described in the preceding embodiment, wherein the reservoir and the further reservoir are arranged adjacent to each other.

[0116] Embodiment 44: A medical device described in any one of the preceding two embodiments, further comprising at least one mixing device, the mixing device configured to mix the therapeutic medical fluid of the reservoir with a further therapeutic medical fluid of the further reservoir so that a mixture is formed before the mixture is applied to a user via the cannula.

[0117] Embodiment 45: A medical device according to any one of the preceding three embodiments, wherein the mixing device comprises at least one static mixer.

[0118] Embodiment 46: A medical device described in any one of the preceding embodiments, wherein the cannula is at least partially connected to the patch base and / or disposed inside the patch base.

[0119] Embodiment 47: A pharmaceutical device for delivering at least one therapeutic medical fluid to a user, comprising: At least one first part, the first part comprising at least one medical device according to any one of the preceding embodiments referring to a medical device; and at least one second portion, the second portion comprising at least one drug pump fluidly connectable to the cannula, the second portion further comprising at least one electronics unit.

[0120] Embodiment 48: A pharmaceutical device according to the preceding embodiment, wherein the second part, in particular the electronic device unit, has at least one energy supply component, in particular a battery and / or an accumulator.

[0121] Embodiment 49: A pharmaceutical device as described in the preceding embodiment, wherein the first part is a disposable component and the second part is a reusable component.

[0122] Embodiment 50: A pharmaceutical device as described in any one of the preceding embodiments referring to a pharmaceutical device, wherein the second part further comprises at least one energy storage device.

[0123] Embodiment 51: The pharmaceutical device of the preceding embodiment, wherein the energy storage device is selected from the group consisting of a battery and a rechargeable battery.

[0124] Embodiment 52: A pharmaceutical device, wherein the first part and / or the second part are watertight components. 2. The pharmaceutical device of any one of the preceding embodiments.

[0125] Embodiment 53: A drug device according to any one of the preceding embodiments referring to a drug device, wherein the drug pump is a positive displacement pump.

[0126] Embodiment 54: A pharmaceutical device as described in the preceding embodiment, wherein the positive displacement pump is configured to move at least one piston of the medical device in the extension direction of the reservoir, specifically via at least one drive spindle of the medical device.

[0127] Embodiment 55: A pharmaceutical device described in any one of the preceding embodiments referring to a pharmaceutical device, wherein the first part and the second part are configured to establish at least one connection selected from the group consisting of a form-fit connection, a press-fit connection.

[0128] Embodiment 56: The medication device of the preceding embodiment, wherein the first part and the second part are connectable via at least one linear slide mechanism, the first part having at least one linear slide receptacle and the second part having at least one linear slide guide rail or vice versa, and the linear slide receptacle and the linear slide guide rail together form a linear slide connector configured to establish a releasable mechanical connection between the first part and the second part.

[0129] Embodiment 57: A medication device as described in the preceding embodiment, wherein the linear slide guide rail and the linear slide receptacle are complementary in shape to each other.

[0130] Embodiment 58: A pharmaceutical device according to any one of the preceding embodiments referring to a pharmaceutical device, wherein the second part is coplanar with the first part.

[0131] Embodiment 59: A method for percutaneously inserting a cannula into body tissue, comprising: a) providing a pharmaceutical device according to any one of the preceding embodiments referring to a pharmaceutical device; b) placing the first portion on the user's skin; c) assembling the first part and the second part such that the first part and the second part establish at least one connection selected from the group consisting of a form-fit connection, a press-fit connection; d) Triggering an integrated insertion mechanism, thereby driving the cannula from a stored position within the patch to an insertion position within the body tissue.

[0132] Embodiment 60: The method according to the preceding embodiment, wherein step b) is performed before carrying out step c).

[0133] Embodiment 61: A method according to any one of the preceding two embodiments, wherein step b) is performed after carrying out step c). [Brief description of the drawings]

[0134] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims. In it, each optional feature can be realized in an independent manner as well as in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated diagrammatically in the figures, in which the same reference signs in these figures refer to the same or functionally comparable elements. The diagram is as follows: [Figure 1A] FIG. 1A shows an exploded view of an exemplary drug device. [Figure 1B] FIG. 1B is an exploded view of an exemplary drug device. [Figure 1C] FIG. 1C is an assembly diagram showing an exemplary drug device. [Diagram 2] 1 is a perspective view of an exemplary embodiment of a medical device according to the present invention. [Figure 3A] 3A-3D are detailed views showing an exemplary embodiment of a drug device in different assembled states. [Figure 3B] 3A-3B are cross-sectional views showing an exemplary embodiment of a drug device in different assembled states. [Figure 3C] 3C are detailed views showing an exemplary embodiment of a drug device in different assembled states. [Figure 3D] 3A-3D are cross-sectional views showing an exemplary embodiment of a drug device in different assembled states. [Figure 3E] 3E-3F are detailed views showing an exemplary embodiment of a drug device in different assembled states. [Figure 3F] 3A-3F are cross-sectional views showing an exemplary embodiment of a drug device in different assembled states. [Figure 3G] Detail views (FIG. 3G) showing an exemplary embodiment of a drug device in different assembled states. [Figure 4A] 1 is a cross-sectional view illustrating an exemplary embodiment of a medical device. [Figure 4B] 1 is a cross-sectional view illustrating an exemplary embodiment of a medical device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0135] Figures 1A-1C show an exemplary drug device 110 for delivering at least one therapeutic medical fluid to a user. In Figures 1A-1B, the drug device 110 is shown in an exploded state, whereby a perspective view is shown in Figure 1A, while a cross-sectional view is shown in Figure 1B. In Figure 1C, the drug device 110 is shown in an assembled state, whereby the drug device 110 is shown in a cross-sectional view.

[0136] The drug device 110 comprises at least one first portion 112 and at least one second portion 114. The first portion 112 comprises at least one medical device 116, which will be described in further detail below. As specifically shown in FIG. 1B, the second portion 114 comprises at least one drug pump 118. Additionally, the second portion 114 comprises at least one electronics unit 120 and may comprise one or more energy storage devices (not shown), such as batteries.

[0137] The second portion 114 can have a housing 122 configured to at least partially receive the first portion 112. Thus, the housing 122 as shown in FIG. 1B can have a free volume 124. The free volume 124 can be configured to receive the first portion 112 such that the first portion 112 is in direct contact with a wall 126 of the second portion 114.

[0138] The first portion 112 and the second portion 114 can be configured to establish at least one mechanical connection, such as a form-fit connection. Specifically, the first portion 112 and the second portion 114 can be connectable via at least one linear slide mechanism 128. As shown in FIG. 1A, the first portion 112 can include at least one linear slide receptacle 130, and the second portion 114 can include at least one linear slide guide rail 132. The linear slide receptacle 130 and the linear slide guide rail 132 can be configured to establish a releasable mechanical connection between the first portion 112 and the second portion 114. The linear slide guide rail 132 can be formed as a protrusion 134 of the second portion 114. The linear slide guide rail 132 and the linear slide receptacle 130 can be complementary in shape to each other. Illustratively, the linear slide receptacle 130 and the linear slide guide rail 132 can have an elongated shape and can extend along a longitudinal axis 136 of the first portion 112 and / or the second portion 114 .

[0139] Figure 2 shows an exemplary embodiment of a medical device 116 according to the present invention in a perspective view. The medical device 116 may be a component of the first part 112 as shown in Figures 1A to 1C. Accordingly, reference may be made to the above description.

[0140] The medical device 116 comprises at least one patch 138 configured to be attached to the skin of a user. The patch 138 comprises at least one patch base 140. Thus, the patch 138, specifically the patch base 140, can comprise at least one adhesive surface 142. Exemplarily, the patch base 140 has a bandage 143, and the adhesive surface 142 can be a part of the bandage 143. The patch 138 further comprises at least one integrated insertion mechanism 144 for driving the cannula 145 from a storage position in the patch 138 to an insertion position in the body tissue. The integrated insertion mechanism 144 is a spring-driven insertion mechanism 148. The second part 114 mentioned above can be an external element 191 connectable to the medical device 116. The integrated insertion mechanism 144 can be configured to be driven by a force established when connecting the external element 191 to the medical device 116.

[0141] The patch 138 further comprises at least one reservoir 146 configured to store at least one therapeutic medical fluid. In particular, the reservoir 146 can be filled with insulin. The reservoir 146 can comprise at least one cylindrical vial 150. The cylindrical vial 150 can be in particular rigid. The medical device 116 can further comprise at least one further reservoir 152. The further reservoir 152 and the reservoir 146 can be arranged adjacent to each other. Thus, the reservoir 146 and the further reservoir 152 can be arranged in a space-saving manner. The reservoir 146 and the further reservoir 152 can each be configured to store the same therapeutic medical fluid. Thus, the supply of the therapeutic medical fluid can be increased and the number of replacements of the reservoirs 146, 152 and thus the medical device 116 can be reduced. However, instead, the further reservoir 152 can be configured to store at least one further therapeutic medical fluid. Thereby, the medical device 116 may further comprise at least one mixing device 154. The mixing device 154 may comprise at least one static mixer 156 and may be configured to mix the therapeutic medical fluid of the reservoir 146 and the further therapeutic medical fluid of the further reservoir 152 such that a mixture is formed before the fluid is applied. The reservoir 146 and the further reservoir 148 may each be fluidly connected to the mixing device 154 via a tube 158. The medical device 116 may further comprise at least one piston 160, specifically at least one piston rod 162. The piston 162 may be configured to displace the therapeutic medical fluid of the reservoirs 146, 152. The medical device 116 may further comprise at least one drive spindle 164. The drive spindle 164 may be operably connectable to the drug pump 118, as shown in FIG. 1A-1B.

[0142] The integrated insertion mechanism 144 may further comprise at least one spring element 168. Specifically, the spring element 168 may be configured to tension the cannula 145 prior to insertion into the body tissue. The reservoir 146 may be at least partially received within an interior space 170 of the spring element 168. Thus, the reservoir 146 and the spring element 168 may be arranged in a space-saving manner.

[0143] The integrated insertion mechanism 144 may further comprise at least one drive unit 166 configured to urge the cannula 145 in the insertion direction, preferably by pushing the cannula 145. The function of the drive unit 166 may be described in more detail below.

[0144] Moreover, the medical device 116 may further comprise at least one elongated element 172. The elongated element 172 may extend laterally, as indicated by an arrow 174, in particular perpendicular to the extension direction of the spring element 168. The patch base 140 may comprise a sliding guide receptacle 176, preferably a linear sliding guide rail 178. The linear sliding guide rail 178 may extend parallel to the extension direction of the cannula. The linear sliding guide rail 178 may be configured to at least partially receive and guide a protrusion 180 of the elongated element 172. The protrusion 180 may be configured to slide within the linear sliding guide rail 178. The protrusion 180 may have a receptacle (not shown) for fixedly receiving one end of the cannula 145. Furthermore, the reservoir 146 and the further reservoir 152 may be connectable to the cannula 145 via at least one flow channel 182. In this embodiment, one end of the flow channel 182 can be received in the protrusion 180 of the elongated element 172. The other end of the flow channel 182 can be fluidly connected to the mixing device 154. The protrusion 180 can thus be configured to establish a fluid connection between the flow channel 182, e.g., the reservoir 146 and the further reservoir 152, and the cannula 145. The function of the elongated element 172 can be explained in more detail below.

[0145] The integrated insertion mechanism 144 may further comprise at least one release button 184. The release button 184 may be an elongated element having a first end 186 and a second end 188. The first end 186 may have a receptacle 190. The receptacle 190 may have a shape corresponding to the shape of the elongated element 172. Illustratively, the elongated element 172 may be a cylinder having a round cross section, and the receptacle 190 may have a correspondingly round shape. The second end 188 of the release button 184 may be disposed outside the patch 138. Thus, the second end 188 may be accessible to the user or patient. The function of the release button 184 may be described in more detail below.

[0146] Figures 3A to 3G show an exemplary embodiment of a drug device 110 in different assembled states in various cross-sectional views (Figures 3B, 3D and 3F) and in various detailed views (Figures 3A, 3C, 3E, 3G). The drug device 110 may at least partially correspond to the medical device 116 according to Figures 1A and 1B. The medical device 116 of the drug device 110 may at least partially correspond to the medical device 116 according to Figure 2. Accordingly, reference may be made to the description of Figures 1A to 2 above.

[0147] 3A shows a detailed view of the integrated insertion mechanism 144 before the first and second portions 112, 114 are assembled. The medical device 116 can include an elongated element 172. The elongated element 172 is held in place by a release button 184 having a first end 186 and a second end 188 (not shown in FIG. 3A). The first end 186 can include a receptacle 190. Thus, the elongated element 172 can have a cylindrical shape and the receptacle 190 can have a corresponding round cross-section.

[0148] The integrated insertion mechanism 144 may further include at least one interlocking element 192 configured to lock the drive unit 166 in a fixed position. The interlocking element 192 can be fixedly connected to the drive unit 166. The interlocking element 192 can include at least one first interlocking element component 194 and at least one second interlocking element component 196. The first interlocking element component 194 and the second interlocking element component 196 can be made at least in part from an elastic material. The first interlocking element component 194 and the second interlocking element component 196 can be configured to form a mechanical connection, specifically a form-fit connection as described in more detail below. The interlocking element can have a snap closure 198 with a clip mechanism. The click mechanism can be a one-way clip mechanism.

[0149] In FIG. 3B, a cross-sectional view of the drug device 110 is shown. The drug device 10 comprises a first portion 112 having a medical device 116. In FIG. 3B, the first portion 112 and the second portion 114 are partially assembled. At this stage, the first portion 112 can already be positioned and attached to a skin site of a user or patient, such as via an adhesive surface 142. Alternatively, the assembly of the first portion 112 and the second portion 114 can be performed while the first portion 112 is not yet attached to the skin site. As described above with respect to FIG. 1A and FIG. 1B, the first portion 112 and the second portion 114 can be connectable via at least one linear slide mechanism 128.

[0150] The elongated element 172 may comprise a protrusion 180. The reservoir 146 may be connectable to the cannula 145 via a flow channel 182. One end 200 of the flow channel 182 may be received in the protrusion 180 of the elongated element 172. One extracorporeal end 202 of the cannula 145 may likewise be received in the protrusion 180. Thus, the protrusion 180 may be configured to establish a fluid connection between the flow channel 182, e.g. the reservoir 146 and the further reservoir 152, and the cannula 145.

[0151] In FIG. 3B, the cannula 145 is shown in a storage position 204. Thus, the cannula 145, specifically the internal body end 206 of the cannula 145, can be received within the patch 138. The patch 138 can have a passage opening 208 so that the cannula 145 can be inserted into body tissue, as described in more detail below. The patch 138 can further comprise at least one cannula receptacle 210 configured to receive at least a portion of the cannula 145. Furthermore, the patch base 140 can comprise a sliding guide receptacle 176, preferably a linear sliding guide rail 178, which can be configured to receive and guide the protrusion 180 of the elongated element 172. Thus, the protrusion 180 can be configured to slide within the linear sliding guide rail 178.

[0152] The cannula 145 has a lumen that is completely or partially surrounded by a wall 211 of the cannula 145. In particular, the cannula 145 can be a closed cannula with the wall 211. Furthermore, the cannula 145 can be an intravenous cannula 212. In particular, the intravenous cannula 212 can be at least partially made of steel, in particular stainless steel. The steel, in particular stainless steel, can be biocompatible. Furthermore, the application of steel, in particular stainless steel, can provide a rigid intravenous cannula. The cannula 145 can be a pre-bent cannula 214. The cannula 145 can thus be at least partially non-straight, at least in the absence of external forces. In particular, the cannula 145 can be embodied as having the shape of a segment of a circle, in part or in part.

[0153] In the partially assembled state as shown in FIG. 3B, the interlocking element 192 can contact the elongated element 172. Thus, the first interlocking element configuration 3C. The connection between the elongated element 172 and the at least one second interlocking element component 196 can be released. The second interlocking element component 196 can surround the elongated element 172. Meanwhile, the receptacle 190 of the release button 184 further secures the elongated element 172. This state is also shown in detail in FIG. 3C.

[0154] In FIG. 3D, a cross-sectional view of the drug device 110 is shown. The drug device 10 comprises a first part 112 having a medical device 116. In FIG. 3D, the first part 112 and the second part 114 are assembled. Thus, the housing 122 can be flush with the patch 138. The receptacle 184 of the release button 184 can further secure the elongated element 172. Thus, the receptacle 190 of the release button 184 can receive the elongated element 172. The elongated element 172 can be disposed between the first interlock element component 194 and at least one second interlock element component 196. Thus, the first interlock element component 194 and the at least one second interlock element component 196 can surround the elongated element 172. The first interlock element component 194 and the second interlock element component 196 can be configured to form a mechanical connection 216. This condition is also shown in detail in FIG. 3E.

[0155] 3F shows a cross-sectional view of the drug device 110. The drug device 10 comprises a first portion 112 having a medical device 116. In FIG. 3F, the first portion 112 and the second portion 114 are assembled and the integrated insertion mechanism 144 is triggered. The cannula 145 is thus in the insertion position 218.

[0156] The integrated insertion mechanism 144 can be triggerable via a release button 184. Thus, by pushing the second end 188 in a direction across the skin site (not shown), as indicated by arrow 220, the first end 186, e.g., receptacle 190, can release the elongated element 172. The spring element 168 can thereby relax in an insertion direction, as indicated by arrow 174. As a result, the drive unit 166 can move in the insertion direction. The interlock element 194 can be fixedly connected to the drive unit 166, so that the elongated element 172, having the extracorporeal end 202 of the cannula 145 received in the protrusion 180 of the elongated element 172, also moves in the insertion direction. The cannula 145, specifically the intracorporeal end 202 of the cannula 145, can extend through the passage opening 208 and can be inserted into body tissue (not shown). Thereby, the flow channel 182, which may be flexible, may pass from a bent configuration to a stretched configuration, and thus, fluid communication between the reservoir 146 and the cannula 145 via the flow channel 182 may be maintained. This condition is also shown in detail in FIG. 3G.

[0157] 4A and 4B show an exemplary embodiment of the medical device 116 in different cross-sectional views. The medical device 116 corresponds in part to the medical device 116 as shown in FIGS. 1A to 3G. The above description may be referred to accordingly. The medical device 116 comprises a patch 138 and a cannula 145. Furthermore, the patch 138 comprises a reservoir 146. For details of these components, the above description may be referred to.

[0158] The patch 138 also includes an integrated insertion mechanism 144. Furthermore, the medical device 116 may have a drive unit 166. In the medical device 116 according to Figs. 4A and 4B, the drive unit 166 may be movable in a direction parallel to the insertion direction, as indicated by the arrow 222. Thus, the spring element 168 may be compressible in the insertion direction by the drive unit 166. The extracorporeal end 202 of the cannula 145 may be fixedly attached to the element 224. The element 224 may be fixedly attached to the drive unit 166. 166 may be in direct contact with the support surface 226 .

[0159] In Fig. 4A, the cannula 145 is in the storage position 204. Thus, the cannula 145, specifically the internal body end 206 of the cannula 145, is received in the patch 138. By moving the drive unit 166 in the insertion direction, the element 224 can slide along the sliding guide receptacle 176 of the passage 138. Thus, the cannula 145 can be driven from the patch 138 to the insertion position 218 in the body tissue as shown in Fig. 4B. The element 224 can be received by a receptacle 228 arranged near the passage opening 208. Specifically, the element 224 can be configured to seal the receptacle 228.

[0160] Additionally, moving the drive unit 166 in the insertion direction can tension the spring element 168. Thus, in the insertion position 218, the drive unit 166 can return to its original position due to the tension of the spring element 168 while the element 224 remains within the receptacle 228. [Explanation of symbols]

[0161] 110 Pharmaceutical Devices 112 First Part 114 Second Part 116 Medical Devices 118 Drug Pump 120 Electronics Unit 122 Housing 124 Free volume 126 Wall 128 Linear Slide Mechanism 130 Linear Slide Receptacle 132 Linear Slide Guide Rail 134 Protrusion 136 Longitudinal axis 138 Patch 140 Patch Base 142 Adhesive surface 143 Bandage 144 Integrated Insertion Mechanism 145 Cannula 146 Reservoir 148 Spring-driven insertion mechanism 150 Cylindrical Vials 152 More Reservoirs 154 Mixing equipment 156 Static Mixer 158 tube 160 Piston 162 Piston rod 164 Drive spindle 166 Drive Unit 168 Spring Elements 170 Interior Space 172 Elongated element 174 Arrow 176 Slide guide receptacle 178 Linear Slide Guide Rail 180 protrusion 182 Channel 184 Release button 186 First End 188 Second End 190 Receptacle 191 External Elements 192 Interlocking Elements 194 First interlocking element receptacle 196 Second Interlocking Element Receptacle 198 Snap Closure 200 End 202 External end 204 Storage Location 206 End of the body 208 Passage opening 210 Cannula receptacle 211 Wall 212 Infusion Cannula 214 Pre-bent Cannula 216 Mechanical Connection 218 Insertion position 220 Arrow 222 Arrow 224 elements 226 Support surface 228 Receptacle

Claims

1. A medical device (116) for percutaneously inserting a cannula (145) into body tissue, comprising: At least one cannula (145) having a lumen completely or partially surrounded by a wall (211) of said cannula (145); at least one patch (138) configured to be attached to a user's skin, said patch (138) comprising at least one patch base (140), said patch (138) further comprising at least one integrated insertion mechanism (144) for actuating said cannula (145) from a storage position (204) within said patch (138) to an insertion position (218) within body tissue; the patch (138) further comprises at least one reservoir (146) configured to store at least one therapeutic medical fluid, and the integrated insertion mechanism (144) is a spring-driven insertion mechanism (148); the integrated insertion mechanism (144) comprises at least one drive unit (166) configured to bias the cannula (145) in an insertion direction; the integrated insertion mechanism (144) further comprises at least one interlocking element (192) configured to secure the drive unit (166) against movement, the interlocking element (192) being fixedly connected to the drive unit (166); The medical device (116), wherein the interlock element (192) comprises at least one first interlock element component (194) and at least one second interlock element component (196), the first interlock element component (194) and the second interlock element component (196) being at least partially made from a resilient material, and the first interlock element component (194) and the second interlock element component (196) being configured to form a mechanical connection (216) with the drive unit (166) to secure the drive unit (166).

2. 2. The medical device (116) of claim 1, wherein the cannula (145) is selected from the group consisting of an insertion cannula for inserting an intravenous cannula into body tissue and an intravenous cannula (212).

3. The medical device (116) of claim 1 or 2, wherein the integrated insertion mechanism (144) is a slide mechanism.

4. The medical device (116) of any one of claims 1 to 3, wherein the medical device (116) is connectable to at least one external element (191), and the integrated insertion mechanism (144) is configured to be driven by a force established when connecting the external element (191) to the medical device (116).

5. 2. The medical device (116) of claim 1, wherein the integrated insertion mechanism (144) further comprises at least one spring element (168), the spring element (168) being tensionable parallel to an insertion direction, and the drive unit (166) configured to compress the spring element (168).

6. The medical device (116) of claim 1, further comprising at least one elongated element (172) having at least one protrusion (180), the cannula (145) being fixedly received within a receptacle of the protrusion (180), and the interlocking element (192) configured to surround the elongated element (172).

7. The medical device (116) of claim 6, wherein the integrated insertion mechanism (144) further comprises at least one release button (184), the release button (184) configured to hold the elongated element (172) in a predetermined position and subsequently release the elongated element (172).

8. A medical device (116) as described in claim 6 or 7, wherein the patch base (140) has at least one sliding guide receptacle (176), the sliding guide receptacle (176) configured to at least partially receive the protrusion (180), and the protrusion (180) configured to slide within the sliding guide receptacle (176).

9. A pharmaceutical device (110) for delivering at least one therapeutic medical fluid to a user, comprising: At least one first portion (112), comprising at least one medical device (116) according to any one of claims 1 to 8, which refers to a medical device (116); and at least one second portion (114), said second portion (114) comprising at least one drug pump (118) fluidly connectable to said cannula (145), said second portion (114) further comprising at least one electronics unit (120).

10. The pharmaceutical device (110) of claim 9, wherein the first portion (112) is a disposable component and the second portion (114) is a reusable component.

11. A drug device (110) as described in claim 9 or 10, wherein the first part (112) and the second part (114) are configured to establish at least one connection selected from the group consisting of a form-fit connection and a press-fit connection.

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