RU2798901C2 - Medical device for percutaneous cannula insert in body tissue - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to devices for percutaneous cannula insertion into body tissue. The device contains at least one cannula (145), the cannula (145) has a lumen which is completely or partially limited by the wall (211) of the cannula (145), and at least one pad (138) configured to be installed on the skin of the user, the pad (138) contains at least one pad base (140), besides the pad (138) additionally contains at least one integrated insert mechanism (144) for moving the cannula (145) from the storage position (204) inside the patch (138) to the inserted position (218) inside the body tissue. The pad (138) additionally contains at least one container (146) made for storing at least one therapeutic medical fluid, and the integrated insertion mechanism (144) is a spring-driven insertion mechanism (148), moreover, the integrated mechanism (144) for insertion contains at least one drive unit (166) made for forced shifting of the cannula (145) in the direction of insertion, and at least one interlocking element (192) made for fixing the drive unit (166) in a fixed position, while the interlocking element (192) is fixedly connected to the drive unit (166) and contains a snap-on locking element (198).

EFFECT: obtaining a medical device for percutaneous cannula insert in body tissue.

13 cl, 4 dwg

Description

Technical field

The present invention relates to a medical device for inserting a cannula into body tissue percutaneously, a device for delivering at least one drug to a user, and a method for inserting a cannula into body tissue percutaneously. Said method and devices in accordance with the present invention can generally be used to deliver insulin to a user. This invention can be applied both in the field of home care and in the field of professional care, for example, in hospitals. In general, other applications are possible.

State of the art

Drug delivery to the user, and more specifically insulin delivery, plays an important role in the prevention and treatment of diseases, in particular in the treatment of diabetes mellitus. In addition to the use of pens or syringes, delivery of insulin can be carried out, in particular, through the use of insulin pumps.

In particular, the user is typically required to wear the insulin pump on his or her body at all times, resulting in the desirable small and compact design of the insulin pump and its components. Conventional drug delivery pumps, such as for example insulin, comprise a plurality of drug containers. As an example, liquid delivery devices are disclosed in WO 2011/046950 A1. Said liquid delivery device comprises a housing containing a liquid container. The needle is in hydraulic communication with the fluid reservoir in the on position and is not in hydraulic communication with the fluid reservoir in the standby and storage positions. The proximal end of the biasing element is connected to said body, and the distal end of the biasing element is configured to apply force to the liquid container. The piston element passes through the bias element and is connected to the distal end of the bias element. The piston element is fixed relative to the housing in a locked position so that the biasing element does not transmit force to the liquid reservoir, and the piston element is movable relative to the housing in the released position so that the biasing element transmits force to the liquid reservoir. Moving the needle from the stored position to the ready-to-use position moves the plunger from the locked position to the released position.

WO 2005/002649 A1 describes medical devices that are designed to be applied to a user's skin surface and contain a transdermal device that is supplied in a sterile state. Thus, a medical device is provided, comprising a mounting surface configured to be applied to the skin of a subject, a first part containing a first end capable of penetrating the subject's skin, and a second part in fluid communication with the first part and containing a second end. The device further comprises a barrier that can be transformed from an initial configuration, comprising the first and second parts in the initial aseptic state, to a second configuration, in which the ends of the first and second parts can communicate with the outer part through the barrier, while the barrier does not closes the mounting surface.

WO 2017/220681 A1 describes a medical device for transdermal insertion of an insertable element into body tissue. Said medical device comprises: at least one insertion element, wherein the insertion element comprises at least one in vivo distal end for subcutaneous insertion and at least one ex vivo proximal end; at least one insertion cannula for subcutaneous insertion of the insertion element, wherein the insertion cannula contains a lumen, which is completely or partially limited by the wall of the insertion cannula, while the insertion element is received in the lumen, while the insertion cannula is a pre-bent insertion cannula. Said medical device further comprises at least one patch, which is configured to be placed on the user's skin. The specified overlay contains the base of the overlay. Said patch includes an integrated insertion mechanism for moving said insertion cannula from a storage position within the patch to an inserted position within body tissue along a curved insertion path.

Despite the advantages of modern insulin delivery pumps, a number of technical challenges remain. Typically, the cannula is inserted using a separate insertion unit or electromechanically, which is located inside the patch. However, because of the external host, there is an external interface for insertion and additional manipulation steps are required. In the case of electromechanics, production efforts increase, which lead to an increase in costs.

Problem to be solved

Thus, it is an object of the present invention to provide a medical device for inserting a cannula into body tissue percutaneously, a device for delivering at least one drug to a user, and a method for inserting a cannula into body tissue percutaneously, which at least partially avoids the disadvantages of known devices and methods of this kind. and which at least partially solve the aforementioned problems. In particular, devices and methods should be disclosed to allow for easy manufacture and simple handling by the user.

The essence of the invention

This problem is solved by using a medical device for inserting a cannula into body tissue percutaneously, a device for delivering at least one drug to a user, and a method for inserting a cannula into body tissue percutaneously with features of independent claims. Preferred embodiments, which may be implemented in isolation or in any arbitrary combination, are listed in the dependent claims.

As used hereinafter, the terms "have", "comprise" or "include" or any arbitrary grammatical variations thereof are used non-exclusively. Thus, these terms can refer both to a situation in which, apart from the feature introduced by these terms, there are no other features present in the entity described in this context, or to a situation in which one or more additional features are present. For example, the expressions "A has B", "A contains B" and "A includes B" can refer to a situation in which, apart from B, there is no other element in A (i.e., a situation in which A only consists exclusively from B), and to a situation in which, in addition to B, in essence A there are one or more additional elements, such as element C, elements C and D, or even additional elements.

In addition, 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 one or more times, will generally only apply once when presenting the corresponding feature or element. In the following, in most cases, when talking about the corresponding feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that the corresponding feature or element may be present once or more once.

In addition, as used hereinafter, the terms "preferably", "more preferably", "in particular", "more specifically", "more specifically", "more specifically" or similar terms are used in conjunction with optional features, without limiting alternative possibilities. . Thus, the features represented by these terms are optional features and are in no way intended to limit the scope of the claims. The present invention, as will be clear to a person skilled in the art, can be performed using alternative features. Likewise, features represented by "in an embodiment of the present invention" or similar expressions are intended to be used as optional features without any limitation to alternative embodiments of the present invention, without any limitation as to the scope of the present invention, and without no restrictions on the possibility of combining the features thus introduced with other optional or mandatory features of the present invention.

The terms "patient" and "user" as used herein are broad terms and their common and traditional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. These terms, in particular, may refer, without limitation, to a human or animal, regardless of the fact that the human or animal, respectively, may be in a healthy state or may suffer from one or more diseases. By way of example, the patient or user may be a diabetic human or animal. However, additionally or alternatively, the present invention may be applied to other types of users or patients or diseases.

The term "body tissue" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. This term, in particular, may refer, without limitation, to the cellular organizational level, intermediate between cells and full lineage. Body tissue may, in particular, be a collection of similar cells of the same origin, which together perform a specific function. Thus, organs can be formed by the functional grouping together of several tissues. As an example for body tissue, interstitial tissue, that is, the connective tissue between cellular elements, if there is a structure, can be mentioned.

In a first aspect of the present invention, a medical device is disclosed for inserting a cannula into body tissue percutaneously. Said medical device contains at least one cannula. The specified cannula contains a lumen, which is completely or partially limited by the wall of the cannula. Additionally, the specified medical device contains at least one pad, made with the possibility of being installed on the skin of the user. Said overlay contains at least one overlay base. The patch further comprises at least one integrated insertion mechanism for moving the cannula from a stored position within the patch to an inserted position within body tissue. The overlay additionally contains at least one container made for storing at least one therapeutic medical fluid. Additionally, the integrated insertion mechanism is a spring-driven insertion mechanism.

The term "medical device" as used herein is a broad term, and its conventional and conventional understanding should be understood by a person skilled in the art and should not be limited to a special or individual understanding. The specified term, in particular, may refer, without limitation, to an arbitrary device made to carry out at least one medical procedure. Therefore, the medical device, in general, can be an arbitrary device, made for the implementation of at least one therapeutic purpose. A medical device, in particular, may contain one component or an assembly of two or more components capable of interacting with each other, for example, to perform one or more therapeutic purposes, for example, to perform a medical procedure. The medical device, as a rule, may also be or may contain at least one of the medical system or medical kit. The medical device as a whole can be used to deliver at least one drug, such as a drug and/or therapeutic agent, to a user. Thus, the medical device may be used as part of one or more medical treatments.

The medical device may in particular be a disposable medical device. The term "one-time" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. The specified term, in particular, may refer, without limitation, to the property of a component or element that must be disposed of after use. Thus, a disposable item or component can be configured to be irreversibly altered or even destroyed during use, for example by mechanical deformation or by irreversibly separating the components of the disposable item. Thus, the disposable item can be configured to be disposed of after use. Thus, this component can be made from at least one material that can be inexpensive and/or easily recyclable. However, other embodiments are also possible.

The medical device may be provided in sterile packaging prior to use. The term "package" may refer to an arbitrary object that is designed to wholly or partially enclose or contain at least one other component, while at least one other component, by way of example, may be a component that requires protection, such as mechanical protection and/or protection against moisture and/or microbial contamination. The term "sterile" can generally refer to the property of an arbitrary object to be at least substantially free of all life forms and/or other biological agents such as prions, viruses, fungi, bacteria, or spore forms. Thus, a sterile object may be treated with at least one sterilization method, one or more of which reduces, eliminates, or deactivates said life forms and/or said other biological agents.

The term "transdermal" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. Said term, in particular, may refer, without limitation, to the property of an arbitrary element to be configured to be completely or at least partially located through the tissue of the patient's or user's body. To do this, the specified element may contain an insertable part. To further make the element suitable for use as a transdermal element, the element may fully or partially provide a biocompatible surface, i.e. a surface that, at least during use, does not cause any harmful effects to the wearer, patient, or body tissue. In addition, the transdermal element as a whole may be sized so that transdermal insertion of the element into body tissue is possible, for example, providing a width in the direction perpendicular to the direction of insertion of not more than 5 mm, preferably not more than 2 mm, more preferably not more than 1, 5 mm. Thus, the term "subcutaneous" may generally refer to the property of an arbitrary element located or lying under the skin and within the tissue of the body of the user or patient. In particular, the object can be made with the possibility of introduction under the skin, for example, in the form of an injection.

The term "cannula" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, may refer, without limitation, to an arbitrary element that can be inserted at least partially into arbitrary tissue of the body, in particular, for the delivery or transfer of an additional element. Therefore, the cannula may in particular be or may comprise a hollow tube or a hollow needle.

As described above, the cannula contains a lumen which is wholly or partly delimited by the wall of the cannula. The term "clearance" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. The specified term, in particular, may refer, without limitation, to the internal volume of an arbitrary element. In particular, the inner volume may be an open inner volume. Thus, the internal volume may not be completely closed or surrounded by the wall of the element. Instead, it may be feasible to flow a liquid medium or insert another object from one end of the element to the other end through the lumen.

The term "wall" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, may refer, without limitation, to an arbitrary structure, in particular, to a structural material that is configured to at least partially surround another object or volume, thereby defining the physical limits of the object. In addition, the wall may be configured to protect the specified volume or other object, at least partially limited by this wall.

In particular, the cannula may be selected from the group consisting of: a closed cannula with a wall circumferentially delimiting the lumen; wherein the term "bounding circumferentially" may generally refer to the property of an arbitrary object or volume to be completely surrounded by another object in at least two dimensions. In particular, the lumen of the cannula may be completely limited by the cannula in directions perpendicular to the direction of passage of the cannula.

The cannula may be selected from the group consisting of: an insertion cannula for inserting an infusion cannula; infusion cannula. The term "infusion cannula" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. Said term may particularly refer, without limitation, to an arbitrary cannula capable of delivering an infusion, i.e. a liquid substance, in particular a liquid substance containing a drug, into body tissue, for example directly into a patient's vein. Therefore, the infusion cannula can be attached to the container containing the liquid substance, in particular, through the ex vivo proximal end of the infusion cannula. The infusion cannula may be part of an infusion set. The term "infusion set" may refer to the collection of components that are required to perform an arbitrary infusion. Thus, in addition to the infusion cannula, the infusion set may further comprise at least one fluid connection for connecting the infusion set to at least one drug delivery device, preferably at least one drug pump.

Alternatively, the cannula may be an insertion cannula for inserting an infusion cannula. The insertion cannula may in particular be an injection needle, wherein the injection needle may be positioned within the lumen of the soft cannula and the injection needle may be removed after insertion of the soft cannula, such as a soft cannula that is configured to remain at least partially in body tissue and remain in body tissue for the useful life of the medical device. The term "soft cannula" may refer to an arbitrary cannula that is at least partially made of at least one soft, for example, elastic material. Said elastic material may in particular comprise at least one elastic material. Thus, the soft cannula may or may comprise a flexible tube. Meanwhile, the injection needle may remain outside the body tissue, but may be embedded in the medical device. In particular, the injection needle may be protected by the medical device so that the injection needle cannot be a source of risk to the user or patient. Thus, a user or patient may have an injection needle that is securely delimited by a medical device, in particular a body of a medical device, attached to body tissue by a medical device. Thus, the injection needle and the soft cannula can be withdrawn from the patient's body at the same time after the useful life of the medical device has expired.

The cannula may at least partially be made from at least one biocompatible material, ie a surface that, at least during use, does not have any harmful effect on the user, patient, or body tissue. The cannula, in particular the infusion cannula, may be at least partially made of steel, in particular stainless steel. Steel, in particular stainless steel, may be biocompatible. In addition, by using steel, in particular stainless steel, a rigid infusion cannula can be provided. However, other materials are possible, such as plastic material.

The cannula may be a pre-bent cannula. The term "pre-bent" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. Said term may in particular refer, without limitation, to a geometric property of an element which, at least in the absence of external forces, has at least a partially indirect shape. Thus, the insertion cannula, at least in the absence of external forces, can be at least partially indirect. Thus, the cannula, in particular, can be completely or partially made indirect, in particular, completely or partially made as having a curved shape. In particular, the cannula may be wholly or partially shaped as a segment of a circle. Thus, in particular, the cannula may be pre-bent so that it is fully or partially shaped like a segment of a circle. More specifically, by way of example, the pre-bent cannula may be a steel cannula, in particular a stainless steel cannula, pre-bent such that it is fully or partially curved, in particular in the form of a segment of a circle.

The cannula may include at least one bend. Thus, parts of the cannula, such as one end of the cannula, can be angled to the main axis. In particular, the cannula may have an angle to the main axis of 30° to 60°, preferably 40° to 45°, more preferably 45°. In particular, the second shape configuration may correspond to the arched shape of the cannula. The arched shape may in particular refer to the state of the cannula, in which the cannula can be bent in such a way that one part of the cannula, in particular one end of the cannula, more specifically one end of the cannula, containing in vivo the distal end of the insertion element, protrudes from the main axes. Thus said bending can preferably be at least substantially free of kinks.

The infusion cannula may be configured to be removed from body tissue after the useful life of the medical device has expired. The term "useful life" may refer to the period of time during which an arbitrary device can be used properly. In particular, the medical device may be configured to remain attached to the skin of a patient or user for several days, such as two to four days. The medical device may be configured to deliver the infusion to body tissue during this period of time, as will be further described below. In addition, during this period of time, the cannula may remain inside the tissue of the body.

The term "overlay" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to the special or individual understanding. This term may specifically refer, without limitation, to a device that is capable of being attached to the skin or skin area of a user or patient. Thus, the patch may comprise at least one attachment component that is configured to connect the body placement member to the skin, such as at least one adhesive surface and/or at least one adhesive strip or patch.

Thus, the term "installation", in particular, may refer, without limitation, to an arbitrary process of fixing or attaching an element to an object. The attachment may be a permanent attachment, for example, the element and object may have a permanent connection to each other that cannot be released when the element block and object are bent or when mechanical stress is applied to the element and/or object.

As stated above, the pad contains the base of the pad. As used hereinafter, the term "base" refers to an arbitrary support of an object on which other components of the object rest. Thus, the base may have a support surface that serves as a bearing surface for other components. In particular, the base of the patch may be a planar element. The patch base may include a bottom surface facing the tissue of the user's or patient's body. The bottom surface may be an adhesive surface as described above. In addition, the patch base may comprise a top surface. The top surface may be configured as a carrier surface and may be configured to serve as a recipient for additional components of the medical device. Therefore, the patch can also be referred to as a body mounting member. The base of the pad may contain at least one through hole. The cannula can be made with the possibility of moving from the lining into the body tissue through the specified passage hole. The shape of the passage opening may correspond to the shape of the cannula.

The term "capacity" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. The term may specifically refer to, without limitation, a hollow element or container that can be wholly or partially filled with a liquid such as a drug and/or therapeutic agent. In particular, the container may be configured to be filled with insulin. The container may be retractably placed in a medical device. In particular, the insertion cannula may be an infusion cannula as described above, and said container may be configured to dispense a therapeutic medical fluid through the cannula. The container may contain at least one cartridge or vial. The bottle may be cylindrical. The container may be a vial, in particular a rigid vial.

The medical device may further comprise at least one additional container configured to store and release at least one additional therapeutic medical fluid. The container and the additional container can be located next to each other. Thus, the container and the additional container can be arranged in a space-saving manner. The medical device may further comprise at least one mixing device. Said medical device may comprise at least one static mixer. The mixing device may be configured to mix the therapeutic medical fluid from the container and the additional therapeutic medical fluid from the additional container in such a way that a mixture is formed before said mixture is delivered to the user through the cannula.

The medical device may further comprise at least one piston, in particular at least one piston rod. The piston may be configured to displace the therapeutic medical fluid of the specified capacity. The term "piston" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. Said term may in particular refer, without limitation, to an arbitrary moving component which is contained in a cylinder and made at least substantially gas-tight and/or water-tight by means of piston rings. In a pump, the piston may be configured to transmit force from the crankshaft to the cylinder to compress or inject fluid into the cylinder. The term "bias" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. This term, in particular, may refer, without limitation, to the process of reducing the free volume of a certain internal space. Thus, by reducing the free volume, a part of the liquid that is received into a certain internal space can leave the internal space, for example, said liquid can be discharged from the internal volume.

The medical device may further comprise at least one drive spindle. Said drive spindle may be operably connected to at least one drug pump. The term "drive spindle" as used herein is a broad term and its conventional and conventional understanding should be understood by those skilled in the art and should not be limited to the special or individual understanding. Said term may in particular refer, without limitation, to an arbitrary rotary axis which is capable of forcing another element in the desired direction, preferably by pushing or pulling the other element. In particular, the drive spindle may be configured to linearly push or retract another element. As described above, the medical device may include at least one piston. Said drug pump may be configured to move the piston by means of a drive spindle. Thus, by rotating the drive spindle, the piston can displace the therapeutic fluid of the reservoir.

The term "insert mechanism" can generally refer to a collection of components that are configured to interact with each other to at least partially insert an element into another object. Therefore, the insertion mechanism can be configured to move the element in the direction of insertion, that is, towards the surface of another object. The inserter may be an integrated inserter. The term "integrated insertion mechanism" may refer to a collection of components that are configured to interact with one another to insert an element at least partially into another object, said collection of components being provided as one, as a whole, and/or as all-in-one system. Thus, the user can find a medical device containing a fully assembled insertion mechanism without having to add other components to the medical device or having to use an additional device in addition to the medical device to insert the cannula into the body tissue. Additionally, optionally, an integrated insertion mechanism may also be provided to subsequently move the cannula back from the inserted position to the storage position. However, the medical device may also be configured to withdraw the medical device from body tissue when the cannula is in the inserted position, as further described below in greater detail.

The term "storage position" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. The term may refer in particular to, without limitation, the position of the cannula within the patch in which the cannula does not protrude into body tissue. In particular, the cannula may be completely or partially surrounded by a patch. The term "inserted position" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term may particularly refer, without limitation, to a position of the cannula in which the cannula fully or partially protrudes from the patch, for example, fully or partially protrudes into body tissue, and preferably the proximal end of the cannula is wholly or partially retained by the patch or connected to the patch . In the storage position and in the inserted position, the cannula may have the same shape or may have a different shape. For example, the cannula may have the same bend radius or the same shape in the storage position.

An integrated insertion mechanism may be configured to move the cannula into the tissue of the user's or patient's body along a curved path. The term "on a curved path" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to a special or individual understanding. Said term may particularly refer, without limitation, to the fact that the tip of the cannula, during movement from the storage position to the inserted position, follows a path that is at least partially indirect. In particular, said path may at least partially be in the form of a segment of a circle.

The term "spring-actuated insertion mechanism" as used herein is a broad term, and its conventional and conventional understanding should be understood by one of skill in the art and should not be limited to special or individual understanding. The term may specifically refer, without limitation, to an arbitrary insertion mechanism in which the interaction of a plurality of components to insert an element at least partially into another object is actuated or triggered by a spring element. Thus, a force can be generated by the spring, in particular the force that is released when the tensioned spring is released from the tensioned position. As a consequence, by releasing the spring from its tensioned position, the cannula can be forcibly moved in the insertion direction, preferably by pushing or pulling the cannula.

The integrated insertion mechanism, in particular the spring-operated insertion mechanism, may be a manual insertion mechanism. The term "manual insertion mechanism" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to a special or individual understanding. Said term may specifically refer, without limitation, to an arbitrary insertion mechanism in which the insertion mechanism is only triggered or controlled by the application of mechanical forces. Mechanical forces, such as the tension of a spring element, as described above or as will be further described in more detail below, may be generated by a manual procedure by the user or patient, as will be described in more detail below. Thus, the integrated insertion mechanism can be started without the need for an electrical power source. The medical device, in particular the patch base, may be configured to be connected to at least one external element interacting with the cannula. The integrated insertion mechanism may be configured to be driven by a force generated when the external element is connected to the medical device.

According to the invention, the integrated insertion mechanism comprises at least one drive unit configured to force the cannula in the direction of insertion, preferably by pushing the cannula. The term "drive unit" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. Said term, in particular, may refer, without limitation, to an element or a combination of elements that are configured to interact with each other to create a force leading to movement, in particular a predetermined movement, of another element. In particular, the drive unit may be configured to force the cannula in the direction of insertion, preferably by pushing or pulling the cannula. In particular, the drive unit can be configured to move in the direction of passage of said container. Thus, the drive unit may at least partially surround said container and be movable along said container.

The integrated insertion mechanism may be a sliding mechanism, preferably a linear sliding mechanism. The term "sliding mechanism" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, may refer, without limitation, to an arbitrary mechanism, which is based on the linear sliding movement of two or more components relative to each other. Thus, the term "sliding motion" may refer to movement along a continuous connection with another element, in particular with the surface, and more precisely the smooth surface, of the other element. In particular, the linear sliding mechanism may include one or more cooperating sliding elements such as one or more guide rails and the like. In addition, the term "linear sliding motion" can generally refer to motion along a straight line, for example in two dimensions.

The integrated insertion mechanism may further comprise at least one spring element. The term "spring element" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, may refer, without limitation, to an arbitrary elastic object that is used to store mechanical energy. In case the object can be connected to the spring element, the spring element can be configured to be tensioned when the object is moved. Thus, the spring element can be configured to move the object back to its original position when the spring element is released. In particular, the spring element may be tensile prior to insertion of the cannula into body tissue. Moreover, the spring member may be configured to support insertion of the cannula into body tissue. The spring element may, for example, be a helical spring element and/or a compression spring element.

In particular, the spring element may be extensible parallel to the insertion direction. The drive unit may be configured to compress the spring element, as will be further described in more detail below. Thus, the spring member can be configured to loosen in the direction of insertion, thereby pushing the cannula in the direction of insertion. In particular, said container can be at least partly received within the spring element. In addition, the cannula may be at least partially received within the spring element. Thus, said components of the medical device can be space-savingly arranged, and the size of the medical device structure can be reduced. The spring element may be configured to prevent, at least to a significant extent, the removal of the cannula from body tissue after insertion. Thus, in the inserted position, the cannula can be at least partially inserted into body tissue. The spring element may be in a relaxed state, thereby applying a force to the cannula in the direction of insertion, in particular, to the ex vivo end of the cannula.

In addition, the medical device may include separation of the movement of the cannula. The spring element may be configured to extend parallel to the insertion direction. Thus, the cannula can be flexible in the direction of insertion.

In addition, according to the invention, the integrated insertion mechanism also comprises at least one interlocking element configured to fix the drive unit in a fixed position. The term "interlocking element" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. Said term may specifically refer, without limitation, to holding or fixing an object in position to prevent unwanted movement or separation from another element, in particular by applying internal pressure. The interlocking element may be fixedly connected to the drive unit.

The interlocking element also contains a snap-on locking element. The term "snap closure" may refer to any closure that engages by a latching or clamping mechanism. Said latching mechanism may be a one-way clamping mechanism.

The intermeshing element may comprise at least one first intermeshing element component and at least one second intermeshing element component, wherein the first intermeshing element component and the second intermeshing element component are at least partially made of an elastic material, wherein the first intermeshing element component and the second the component of the interlocking element is configured to form a mechanical connection, in particular a form-fitting connection. Said form-fitting connection may be a pluggable form-fitting connection.

The medical device may further comprise at least one elongated element. Said elongated element can extend in the transverse direction, in particular perpendicular to the direction of passage of the cannula. The cannula, in particular at least one end of the cannula, can be fixedly received inside the receiving part of the elongated element. The patch base may comprise a sliding guiding receptacle, preferably a linear sliding guiding receptacle. The linear sliding guide receiving portion may be configured to at least partially receive the protrusion of the elongated element. The receiving part may in particular be part of said protrusion. The protrusion may be slidable within the linear sliding guide of the receiving portion. The linear sliding guide of the receiving part can extend in the transverse direction, in particular perpendicular to the direction of passage of the cannula. Said container may be configured to be connected to the cannula through at least one fluid channel. Said liquid channel may, for example, be a flexible tube. One end of the fluid channel may be received within the protrusion of the elongated member. In addition, ex vivo, the proximal end of the cannula can also be at least partially received inside the protrusion of the elongated element. Thus, said protrusion can be configured to create a fluid connection between said fluid passage, such as said container, and the cannula.

The interlocking element may be configured to receive an elongated element. Thus, prior to insertion, when the cannula is in the storage position, the interlocking member can be moved in a direction opposite to the insertion direction. Thus, the interlocking member can be opened, thereby accommodating the elongate member and creating a fixed connection to the elongate member.

The integrated insertion mechanism may further comprise at least one release button. Said release button may be an elongated element with a first end and a second end. Said first end may have a receiving portion. The specified receiving part may have a shape that corresponds to the shape of the elongated element. For example, the elongate member may be a cylinder having a circular cross section and the receiving portion may be circular in shape, respectively. The second end of the release button may be located outside the lining. Thus, the second end may be accessible to the user or patient. The release button may be configured to hold the elongated element in a predetermined position and to subsequently release the elongated element. The release button may be configured to be depressed thereby triggering said integrated insertion mechanism. Thus, the integrated insertion mechanism can be manually triggered. However, other embodiments may be possible. For example, an integrated insertion mechanism can be started as soon as the medical device and external element are assembled. Thus, the medical device can be positioned and fixedly applied to the user's skin area prior to the assembly of the medical device and the outer member. However, other embodiments may also be possible. The integrated inserter may also be a buttonless integrated inserter. For example, an integrated insertion mechanism may be triggered as soon as the external element is connected to the medical device.

In a further aspect of the present invention, a device for delivering a drug in the form of at least one therapeutic medical fluid to a user is disclosed. Said drug delivery device comprises at least one first part. Said first part contains at least one medical device as described above or will be described in more detail below. In addition, said device for drug delivery contains at least one second part. Said second part comprises at least one drug pump configured to be hydraulically connected to the cannula. In addition, the second part contains at least one electronic unit. The drug delivery device comprises at least one medical device as described above or will be further described below.

The term "drug delivery device" as used herein is a broad term and its conventional and conventional understanding should be understood by those skilled in the art and should not be limited to special or individual understanding. The specified term, in particular, may refer, without limitation, to an arbitrary device that is configured to administer or deliver a drug and/or therapeutic agent through a specific route of administration. Such devices are typically used as part of one or more medical treatments. In particular, the term "drug delivery device" may refer to a device for administering insulin using at least one pump.

The terms "first" and "second", commonly used in this document to refer to components or elements, can be considered only as a nomenclature, without numbering or ranking the named elements, without indicating the order, and without excluding the possibility that several kinds of first parts and second parts. In addition, additional parts may be present, such as one or more third parts or elements. Said term "part" may refer to an arbitrary component of an object. Said component may be configured to interact with an additional component of said object. In particular, the first part and the second part of the drug delivery device may be able to interact with each other, for example, to perform one or more therapeutic purposes, for example, to perform a medical procedure, as described 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 waterproof component. In particular, the drug delivery device may be a waterproof drug delivery device. To do this, the second part may have one or more sealing elements, which can be made with the possibility of pressing against at least one surface of the first component. Thus, the inner space formed by the first part and the second part can be sealed in a sealed manner.

The term "drug pump" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to special or individual understanding. Said term, in particular, may refer, without limitation, to an arbitrary pump that is configured to move a drug and/or therapeutic agent by mechanical action. In particular, the drug pump may be an infusion pump that is configured to introduce an arbitrary drug into the patient's circulatory system. In general, the infusion pump may be configured for intravenous or subcutaneous administration. However, other applications are possible. Said drug pump may be a positive displacement piston pump. Said positive displacement piston pump may be configured to move at least one piston of the medical device in the direction of passage of the reservoir, in particular by means of at least one driving spindle of the medical device.

The terms "fluidically connected" or "fluidically connected" can generally refer to a property of two or more elements such that an arbitrary fluid can be transferred between two or more elements. Said drug pump may in particular be an insulin pump. The term "insulin pump" as used herein is a broad term and its conventional and conventional understanding should be understood by one of ordinary skill in the art and should not be limited to a special or individual understanding. This term may particularly refer, without limitation, to a device for administering insulin using at least one pump. The term "fluidically connectable" can thus also be referred to as "operably connected" when referring to hydraulic operation.

The term "electronic unit" as used herein is a broad term, and its conventional and conventional understanding should be clear to a person skilled in the art and should not be limited to a special or individual understanding. This term, in particular, may refer, without limitation, to an arbitrary device containing at least one electronic component. In particular, the electronic unit may comprise at least one electronic component for one or more of performing a measurement with a sensor, performing a voltage measurement, performing a current measurement, recording sensor signals, storing measurement signals or measurement data, transmitting sensor signals or measurement data to another device. The electronic unit may in particular be embodied as a transmitter or may comprise a transmitter for transmitting data. Other embodiments of the electronic components are also possible. The electronic unit may comprise at least one connector, preferably a printed circuit board, more preferably a flexible printed circuit board. The electronic unit may in particular be configured to control and operate the drug pump. In addition, the second part may contain at least one energy storage device. Said energy storage device may be part of an electronic unit. The power storage device may be selected from the group consisting of: battery, rechargeable battery, accumulator. Other embodiments are also possible.

The specified first part and the second part can be configured to create at least one mechanical connection selected from the group consisting of: positive connection, press fit connection. Used in this document, the term "mechanical connection" generally refers to the connection of two or more components through mechanical holding forces. By way of example, the mechanical connection may be or may comprise at least one of a geometric fit or force fit. As used hereinafter, the term "releasable" in the context of a mechanical connection generally refers to the fact that the mechanical connection can be transferred from a disconnected state, also referred to as a non-mated state, to a connected state, also referred to as a mated state, and back to a disconnected state. Thus, the mechanical connection can be closed and released as desired. In particular, the mechanical connection can be detachable without the use of any tools, simply by manual action. By way of example, forces of no more than 50 N, such as no more than 20 N, such as no more than 10 N, may be required to open the connection between the first part and the second part, which can be applied with one hand or even with the user's fingers or fingertips.

In particular, the first part and the second part can be connected via at least one linear sliding mechanism. The first part may comprise at least one linear sliding receiving portion and the second part may comprise at least one linear sliding guide rail, or vice versa. The linear sliding receiving portion and the linear sliding guide rails together may form a linear sliding connector configured to create a releasable mechanical connection between the first part and the second part. As used hereinafter, the terms "linear sliding receptacle" and "linear sliding guide rail" can refer to elements that complement each other and that are cooperating with each other to realize a linear sliding mechanism. For example, the linear sliding guide rail may be formed as a protrusion of the first part, and the linear sliding receiving part may be the second part, or vice versa. However, other embodiments may be possible. The linear sliding guide rail and the linear sliding receiving portion may be shaped to complement each other. For example, the linear sliding receiving portion and the linear guide rail may be elongated and may extend along the longitudinal axis of the first part and/or the second part. The linear sliding receiving part and the linear sliding guide rail together can form a linear sliding connector configured to create a releasable mechanical connection between the electronic unit and the patch. The term "linear sliding connector", also referred to as a linear sliding connection, can generally refer to an arbitrary connector or connection between two linear sliding contours. In this case, as a rule, one or both of the involved linear sliding contours may contain at least one protrusion, and, as an addition, the other of the linear sliding contours may contain at least one linear sliding groove or linear sliding slot, in which the specified protrusion may be directed to form a linear sliding joint or a linear sliding joint.

By connecting the first part and the second part, the interlocking element can be moved in a direction opposite to the insertion direction. Thus, the interlocking member can be opened, thereby accommodating the elongate member and creating a fixed connection to the elongate member.

In a further aspect of the present invention, a method for inserting a cannula into body tissue percutaneously is disclosed. This method includes the steps of the method specified in the independent claims and listed below. The steps of the method may be performed in a given order. However, other orders of the steps of the method are possible. In addition, one or more method steps may be performed in parallel and/or in time with overlap. In addition, one or more steps of the method may be repeated. In addition, there may be additional method steps that are not listed.

This method includes the following steps:

a) providing at least one medical device as described above or will be described in further detail below;

b) placing the first part on the user's skin;

c) assembling the first part and the second part so that the first part and the second part create at least one connection selected from the group consisting of: a positive connection, a press fit connection;

d) triggering the integrated insertion mechanism, thereby moving the cannula from a storage position inside the patch to an inserted position inside the body tissue.

Step b) can be done before step c). Alternatively, step b) can be performed after step c).

The proposed medical device, the device for measuring the analyte, the device for delivering a drug and the proposed method of percutaneous insertion of the inserted element into the body tissue provide many advantages over known devices and methods.

Typically, the infusion cannula can be inserted using a separate insertion assembly or by electromechanics that is located inside the patch. However, because of the external host, there is an external interface for insertion and additional manipulation steps are required. In the case of electromechanics, production efforts increase, which lead to an increase in costs.

In contrast, the medical device, drug delivery device, and method of the present invention enable easy manufacturing and simple manipulation processes by the user. In addition, you can avoid the need to use a separate node for insertion. Thus, additional installation elements as well as an additional manufacturing process can be eliminated.

The energy for inserting the cannula can be provided through an insertion mechanism that is integrated within said patch. An electric drive may not be needed. The cannula may be arched and may be positioned within the patch in a space-saving manner. In addition, the cannula may be a guided cannula and may require only a small opening within the base of the patch. Thus, insertion of the cannula may only be possible with slight deformation of the tissue of the user or patient.

In addition, the spring elements can be positioned within the lining in a space-saving manner. In particular, said container may be located inside the inside of the spring element, or the cannula can be located inside the inside of the spring element.

In addition, after insertion, the cannula can be positioned centrally under the patch. Thus, the cannula may be able to resiliently move during use of the medical device. As a result, the wearing comfort is improved.

Manipulation effort of the user or patient can be reduced because the second part containing the drug pump and the electronic unit can serve as a slider to tension the spring element.

Due to the waterproof design of the drug delivery device, the drug device does not need to be removed from the user's or patient's skin area for showering, bathing, or swimming. The second part can be reusable and said battery can be self-replaced by the user or patient. Alternatively, the second part may have a battery and the second part may have a coating for the charging contact. In addition, inductive charging can be provided.

By using a plurality of containers, for example by using two containers, the medical device can be formed into a flat shape. In addition, using a plurality of containers, you can use more than one kind of liquid.

Summarizing and not excluding additional possible embodiments, the following embodiments may be envisaged:

Embodiment 1: A medical device for inserting a cannula into body tissue percutaneously, the medical device comprising:

- at least one cannula, while the cannula contains a lumen, which is completely or partially limited by the wall of the cannula;

- at least one patch configured to be placed on the user's skin, wherein the patch comprises at least one patch base, the patch further comprising at least one integrated insertion mechanism for moving the insertable cannula from a storage position within the patch to an inserted position within body tissue;

wherein the patch further comprises at least one container configured to store at least one therapeutic medical fluid, and wherein the integrated insertion mechanism is a spring-driven insertion mechanism.

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

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

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

Embodiment 5: The medical device according to the previous embodiment, wherein the driving unit is configured to move in the direction of passage of the container.

Embodiment 6: The medical device according to any of the two preceding embodiments, wherein the drive unit at least partially surrounds the container and is movable along the container.

Embodiment 7: A medical device according to any one of the preceding three embodiments, wherein the medical device, in particular the patch base, is operable to be connected to at least one external element, the integrated insertion mechanism being operable by means of force created when an external element is connected to a medical device.

Embodiment 8: The medical device of any one of the preceding four embodiments, wherein the integrated insertion mechanism further comprises at least one spring element.

Embodiment 9: The medical device of the previous embodiment, wherein the spring is extensible parallel to the insertion direction.

Embodiment 10: The medical device of the previous embodiment, wherein the driving unit is configured to compress the spring member.

Embodiment 11: The medical device of either of the two preceding embodiments, wherein the container is at least partially received within the spring element.

Embodiment 12: A medical device according to any of the preceding three embodiments, wherein the cannula is at least partially received within the spring element.

Embodiment 13: The medical device according to any one of the preceding four embodiments, wherein the spring member is configured to push the cannula in the insertion direction.

Embodiment 14: A medical device according to any one of the preceding five embodiments, wherein the spring member is configured to prevent at least a substantial degree of removal of the cannula from body tissue after insertion.

Embodiment 15: The medical device according to any one of the ten preceding embodiments, wherein the integrated insertion mechanism further comprises at least one interlocking member configured to fix the drive unit in a fixed position.

Embodiment 16: The medical device of the previous embodiment, wherein the interlocking member is fixedly connected to the driving unit.

Embodiment 17: The medical device according to either of the preceding two embodiments, wherein the interlocking member comprises a snap-on closure member.

Embodiment 18: The medical device of the preceding embodiment, wherein the intermeshing element comprises at least one first intermeshing element component and at least one second intermeshing element component, wherein the first intermeshing element component and the second intermeshing element component are at least partially made of an elastic material, wherein the first component of the interlocking element and the second component of the interlocking element are configured to form a mechanical connection, in particular a form-fitting connection.

Embodiment 19: The medical device of the previous embodiment, wherein the positive-fit connection is a releasable positive-fit connection.

Embodiment 20: The medical device according to any one of the five preceding embodiments, wherein the medical device further comprises at least one elongate element containing at least one protrusion, wherein the cannula, in particular at least one end of the cannula, is fixedly received inside the receiving part of the protrusion, while the interlocking element is configured to accommodate the elongated element.

Embodiment 21: The medical device of the preceding embodiment, wherein the integrated insertion mechanism further comprises at least one release button, the release button being configured to hold the elongate element in a predetermined position and to subsequently release the elongate element.

Embodiment 22: A medical device according to any one of the preceding two embodiments, wherein the patch base comprises at least one sliding guide rail, preferably a linear sliding guide rail, wherein the linear sliding guide rail is configured to at least partially receive a protrusion, wherein the protrusion made with the possibility of sliding inside the linear sliding guide rail.

Embodiment 23: A medical device according to any one of the preceding three embodiments, wherein the release button is configured to be depressed, thereby triggering said integrated insertion mechanism.

Embodiment 24: A medical device according to any one of the nine preceding embodiments, wherein the interlocking member comprises a clamping mechanism, in particular a one-sided clamping mechanism.

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

Embodiment 26: A medical device according to any of the preceding embodiments, wherein the medical device further comprises at least one piston, in particular at least one piston rod, the piston being configured to displace a therapeutic medical fluid of said container.

Embodiment 27: The medical device of the preceding embodiment, wherein the medical device further comprises at least one drive spindle, the drive spindle being operably coupled to at least one drug pump; wherein said medicinal product is configured to move the piston by means of the drive spindle.

Embodiment 28: A medical device according to any of the preceding embodiments, wherein the container is configured to be connected to a cannula through at least one fluid channel.

Embodiment 29: The medical device of the previous embodiment, wherein the fluid passage is a flexible tube.

Embodiment 30: A medical device according to any of the preceding embodiments, wherein the container is a vial, in particular a rigid vial.

Embodiment 31: The medical device of the previous embodiment, wherein the vial has a cylindrical shape.

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

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

Embodiment 34: A medical device according to any of the preceding embodiments, wherein the cannula is an infusion cannula, wherein the container is configured to dispense a therapeutic medical fluid through the cannula.

Embodiment 35: The medical device of the preceding embodiment, wherein the cannula is pre-bent such that the cannula is at least partially shaped like a segment of a circle.

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

Embodiment 37: A medical device according to any of the preceding embodiments, wherein the integrated insertion mechanism comprises at least one element configured to prevent, at least to a large extent, the removal of the cannula from body tissue after insertion.

Embodiment 38: A medical device according to any of the preceding embodiments, wherein the integrated insertion mechanism is configured to move the cannula from a stored position within the patch to an inserted position within body tissue along a curved insertion path.

Embodiment 39: The medical device of the preceding embodiment, wherein the insertion path is at least partially shaped like a circle segment.

Embodiment 40: A medical device according to any of the preceding embodiments, wherein the patch base comprises at least one passage port, wherein the cannula is movable from the patch into body tissue through said passage port.

Embodiment 41: The medical device of the previous embodiment, wherein the shape of the passage hole corresponds to the shape of a cannula.

Embodiment 42: A medical device according to any of the preceding embodiments, wherein the medical device further comprises at least one additional container configured to store and dispense at least one additional therapeutic medical fluid.

Embodiment 43: The medical device of the previous embodiment, wherein the container and the additional container are located next to each other.

Embodiment 44: The medical device according to any one of the preceding two embodiments, wherein the medical device further comprises at least one mixing device, the mixing device being configured to mix the therapeutic medical fluid from the container and the additional therapeutic medical fluid from the additional container such that a mixture is formed before said mixture is delivered to the user via the cannula.

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

Embodiment 46: A medical device according to any of the preceding embodiments, wherein the cannula is at least partially connected to and/or placed within the patch base.

Embodiment 47: A device for delivering a drug in the form of at least one therapeutic medical fluid to a user, the drug delivery device comprising:

- at least one first part, while the first part contains at least one medical device according to any of the previous embodiments related to a medical device;

- at least one second part, while the second part contains at least one pump for the drug, made with the possibility of hydraulic connection with the cannula, while the second part additionally contains at least one electronic unit.

Embodiment 48: The drug delivery device of the preceding embodiment, wherein the second part, in particular the electronic unit, comprises at least one power supply component, in particular a battery and/or accumulator.

Embodiment 49: The drug delivery device of the preceding embodiment, wherein the first part is a disposable component and the second part is a reusable component.

Embodiment 50: A drug delivery device according to any of the preceding embodiments relating to a medical device, the second part further comprising at least one energy storage device.

Embodiment 51: The drug delivery device of the preceding embodiment, wherein the power storage device is selected from the group consisting of: battery, rechargeable battery.

Embodiment 52: A drug delivery device according to any of the preceding embodiments relating to a medical device, wherein the first part and/or the second part is a waterproof component.

Embodiment 53: The drug delivery device according to any of the preceding embodiments relating to a medical device, wherein the drug delivery pump is a positive displacement piston pump.

Embodiment 54: The drug delivery device of the previous embodiment, wherein the positive displacement piston pump is configured to move at least one piston of the medical device in the direction of passage of the reservoir, in particular by means of at least one driving spindle of the medical device.

Embodiment 55: A drug delivery device according to any of the preceding embodiments relating to a medical device, wherein the first part and the second part are configured to form at least one connection selected from the group consisting of: positive connection, connection with a press fit.

Embodiment 56: The drug delivery device of the preceding embodiment, wherein the first part and the second part are operable to be connected via at least one linear sliding mechanism, wherein the first part comprises at least one linear sliding receiving part and the second part contains at least one linear sliding guide rail, or vice versa, while the linear sliding receiving part and the linear sliding guide rails together form a linear sliding connector designed to create a detachable mechanical connection between the first part and the second part.

Embodiment 57: The drug delivery device of the preceding embodiment, wherein the linear sliding guide rail and the linear sliding receiving portion are shaped to complement each other.

Embodiment 58: A drug delivery device according to any of the preceding embodiments relating to a medical device, the second part being aligned with the first part.

Embodiment 59: A method for inserting a cannula into body tissue percutaneously, the method comprising:

a) providing a drug delivery device according to any of the preceding embodiments relating to a drug delivery device;

b) placing the first part on the user's skin;

c) assembling the first part and the second part so that the first part and the second part create at least one connection selected from the group consisting of: a positive connection, a press fit connection;

d) triggering the integrated insertion mechanism, thereby moving the cannula from a storage position inside the patch to an inserted position within the body tissue.

Embodiment 60: The method of the preceding embodiment, wherein step b) is performed before step c).

Embodiment 61: The method according to any of the two preceding embodiments, wherein step b) is carried out after step c).

Brief description of graphic materials

Additional optional features and embodiments will be disclosed in more detail in the following description of the embodiments, preferably in conjunction with dependent claims. In this case, the corresponding additional features can be implemented in isolation, as well as in any arbitrary possible combination, as will be clear to the specialist. The scope of the present invention is not limited to the preferred embodiments. Embodiments are schematically depicted in the figures. In them, identical reference numbers in these figures refer to identical or functionally comparable elements.

On the figures:

fig. 1A-1C show an example of a drug delivery device disassembled (FIGS. 1A-1B) and assembled (FIG. 1C);

fig. 2 shows an exemplary embodiment of a medical device according to the present invention in perspective view;

fig. 3A-3G show exemplary embodiments of a drug delivery device in various assembled states in various cross-sectional views (FIGS. 3B, 3D, and 3E) and various detailed views (FIGS. 3A, 2C, 3E, 3G); And

fig. 4A and 4B show an exemplary embodiment of a medical device in various cross-sectional views.

Detailed Description of the Invention

1 A-1 B show an example of a device 110 for delivering a drug in the form of at least one therapeutic medical fluid to a user. In FIG. 1A-1B, drug delivery device 100 is shown in an exploded state. Thus, a perspective view is shown in Fig. 1A, while in FIG. 1B shows a sectional view. In FIG. 1B shows a drug delivery device 100 in an assembled state. Thus, the drug delivery device 100 is shown in sectional view.

The drug delivery device 100 includes at least one first part 112 and at least one second part 114. The first part 112 includes at least one medical device 116, which will be further described in more detail below. The second part 114, as shown in particular in FIG. 1B includes at least one drug pump 118. In addition, the second part 114 contains at least one electronic unit 120 and may contain one or more energy storage devices (not shown), such as a battery.

The second part 114 may include a housing 122 configured to at least partially receive the first part 112. Thus, a housing 122 such as shown in FIG. 1B may have a void volume 124. The void volume 124 may be configured to receive the first portion 112 such that the first portion 112 is in direct contact with the walls 126 of the second portion 114.

Said first part 112 and second part 114 may be configured to create at least one mechanical connection, such as a form-fitting connection. In particular, the first part 112 and the second part 114 may be connected via at least one linear sliding mechanism 128. The first part 112 may include at least one linear sliding receiving part 130, and the second part 114 may include at least one linear sliding guide rail 132 as shown in FIG. 1A. The linear sliding receiving portion 130 and the linear sliding guide rail 132 may be configured to create a releasable mechanical connection between the first part 112 and the second part 114. Said linear sliding guide rail 132 may be formed as a protrusion 134 of the second part 114. The linear sliding guide rail 132 and the linear sliding receiving portion 130 may be shaped to complement each other. For example, the linear sliding receiving portion 130 and the linear guide rail 132 may be elongated and may extend along the longitudinal axis 136 of the first portion 112 and/or the second portion 114.

2 shows an exemplary embodiment of a medical device 116 in accordance with the present invention in perspective view. The medical device 116 may be a component of the first part 112 as shown in FIG. 1A-1B. Thus, reference can be made to the description above.

The medical device 116 includes at least one patch 138 configured to be placed on the user's skin. The patch 138 includes at least one patch base 140 . Therefore, the patch 138, in particular the patch base 140, may comprise one adhesive surface 142. For example, the patch base 140 comprises a patch 143 and the adhesive surface 142 may be part of the patch 143. The patch 138 further comprises at least one integrated insertion mechanism 144 to move the cannula 145 from a storage position within the patch 138 to an inserted position within the body tissue. The integrated insertion mechanism 144 is a spring-actuated insertion mechanism 148. The second part 114 as described above may be an external member 191 that is configured to connect to the medical device 116. The integrated insertion mechanism 144 may be configured to be driven by a force generated by connecting the outer member 191 to the medical device 116.

The patch 138 further comprises at least one container 146 configured to store at least one therapeutic medical fluid. In particular, the container 146 may be configured to be filled with insulin. The container 146 may contain at least one cylindrical vial 150. The cylindrical vial 150 may in particular be rigid. Medical device 116 may further comprise at least one additional container 152. Additional container 152 and container 146 may be located adjacent to each other. In this way, container 146 and additional container 152 can be space-savingly arranged. The container 146 and the additional container 152 can respectively be configured to store the same therapeutic medical fluid. Thus, the supply of said therapeutic medical fluid can be increased and the number of changes of the containers 146, 152 and thus the medical device 116 can be reduced. However, as an alternative, the additional container 152 may be configured to store at least one additional therapeutic medical fluid. Thus, the medical device 116 may further comprise at least one mixing device 154. The mixing device 154 may include at least one static mixer 156 and may be configured to mix the therapeutic medical fluid from the container 146 and the additional therapeutic medical fluid from the additional container 152 so that a mixture is formed before said liquids are supplied. The container 146 and the additional container 148 may respectively be configured to be hydraulically connected to the mixing device 154 through the tubes 158. The medical device 116 may further comprise at least one piston 160, in particular at least one piston rod 162. The piston 162 may be configured to displace the therapeutic medical fluid containers 146, 152. The medical device 116 may further comprise at least one drive spindle 164. The drive spindle 164 may be operatively coupled to a drug pump 118 as depicted in FIG. 1A-1B.

The integrated insertion mechanism 144 may further comprise at least one spring element 168. In particular, the spring element 168 may be tensile prior to insertion of the cannula 145 into body tissue. The container 146 can be at least partially received within the interior space 170 of the spring element 168. Thus, the container 146 and the spring element 168 can be space-savingly arranged.

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

Moreover, the medical device 116 may further comprise at least one elongate member 172. The elongate member 172 may extend transversely, in particular perpendicular to the direction of passage of the spring member 168, as illustrated by arrow 174. The patch base 140 may comprise a sliding guide. receiving portion 176, preferably a linear sliding guide rail 178. The linear sliding guide rail 178 may run parallel to the direction of passage of the cannula. The linear sliding guide rail 178 may be configured to at least partially receive and guide the protrusion 180 of the elongate member 172. The protrusion 180 may be configured to slide within the linear sliding guide rail 178. The protrusion 180 may include a receiving portion (not shown) for a stationary receiving one end of the cannula 145. In addition, said container 146 and additional container 152 may be configured to be connected to the cannula 145 through at least one fluid channel 182. In this embodiment, one end of the fluid channel 182 can be received inside the ledge 180 elongated member 172. The other end of the fluid channel 182 may be fluidly connected to the mixing device 154. Thus, the specified protrusion 180 may be configured to create a fluid connection between the specified fluid channel 182, for example, the container 146 and the additional container 152, and the cannula 145 .

The functionality of the elongated member 172 may be further described in more detail below.

The integrated insertion mechanism 144 may further comprise at least one release button 184. Said release button 184 may be an elongated member with a first end 186 and a second end 188. Said first end 186 may have a receptacle 190. Said receptacle 190 may be shaped , which corresponds to the shape of the elongate member 172. For example, the elongate member 172 may be a cylinder having a circular cross section and the receptacle 190 may be circular in shape, respectively. The second end 188 of the release button 184 may be located outside the patch 138. Thus, the second end 188 may be accessible to the user or patient. The functionality of the release button 184 may be further described in more detail below.

Fig. 3A-3G show exemplary embodiments of a drug delivery device 100 in various assembled states in various cross-sectional views (FIGS. 3B, 3D, and 3E) and various detailed views (FIGS. 3A, 2C, 3E, 3G). The drug delivery device 100 may correspond at least in part to the drug delivery device 100 of FIG. 1A and 1B. The medical device 116 of the drug delivery device 100 may correspond to the medical device 116 of FIG. 2. Thus, reference may be made to the description of FIG. 1A-2 above.

In FIG. 3A shows a detailed view of the integrated insertion mechanism 144 prior to assembly of the first part 112 and the second part 114. The medical device 116 may include an elongate member 172. The elongated member 172 is held in position by a release button 184 comprising a first end 186 and a second end 188 (not shown in Fig. 3A). Said first end 186 may include a receptacle 190. Thus, the elongated member 172 may be cylindrical in shape and the receptacle 190 may have a correspondingly circular cross-sectional shape.

The integrated insertion mechanism 144 may further comprise at least one interlocking member 192 configured to lock the drive unit 166 in a fixed position. Interlocking element 192 may be fixedly connected to the drive unit 166. Interlocking element 192 may include at least one first component 194 of the interlocking element and at least one second component 196 of the interlocking element. The first component 194 of the interlocking element and the second component 196 of the interlocking element may be at least partially made of an elastic material. The first intermeshing element component 194 and the second intermeshing element component 196 may be configured to form a mechanical connection, in particular a form-fitting connection, as will be further described in more detail below. The interlocking element may include a snap lock 198 with a clamping mechanism. Said latching mechanism may be a one-way clamping mechanism.

In FIG. 3B shows a cross-sectional view of the drug delivery device 110. The drug delivery device 110 includes a first portion 112 containing a medical device 116. FIG. 3B, the first part 112 and the second part 114 are partially assembled. At this stage, the first part 112 may already be placed and attached to the site of the skin of the user or patient, for example through the adhesive surface 142. Alternatively, the assembly of the first part 112 and the second part 114 may be carried out while the first part 112 is not yet attached to the site. skin. As described above with respect to FIG. 1A and 1B, the first part 112 and the second part 114 may be connected via at least one linear sliding mechanism 128.

Said elongate member 172 may comprise a receiving portion 180. Said container 146 may be configured to be connected to a cannula 145 via a fluid channel 182. One end 200 of fluid channel 182 may be received within projection 180 of elongate member 172. One ex vivo end 202 of cannula 145 may also be received in protrusion 180. Thus, said protrusion 180 may be configured to create a fluid connection between said fluid passage 182, such as container 146 and additional container 152, and cannula 145.

In FIG. 3B, cannula 145 is shown in storage position 204. Thus, the cannula 145, in particular the in vivo end 206 of the cannula 145, can be received within the patch 138. The patch 138 includes a passageway 208 so that the cannula 145 can be received into body tissue, as will be further described in more detail below. . The patch 138 may further comprise at least one cannula receptacle 210 configured to receive at least a portion of the cannula 145. In addition, the patch base 140 may include a sliding guiding receptacle 176, preferably a linear sliding guide rail 178, which may be configured for receiving and guiding the protrusion 180 of the elongated member 172. Thus, the protrusion 180 may be slidable within the linear sliding guide rail 178.

The cannula 145 comprises a lumen that is completely or partially defined by the wall 211 of the cannula 145. In particular, the cannula 145 may be a closed cannula with a wall 211. Additionally, said cannula 145 may be an infusion cannula 212. In particular, the infusion cannula 212 may be at least least partly made of steel, in particular stainless steel. Said steel, in particular said stainless steel, may be biocompatible. In addition, by using steel, in particular stainless steel, a rigid infusion cannula can be provided. The cannula 145 may be a pre-bent cannula 214. Thus, the cannula 145, at least in the absence of external forces, may be at least partially indirect. In particular, the cannula 145 may be completely or partially formed as having the shape of a segment of a circle.

In a partially assembled state, such as shown in FIG. 3B, the intermeshing member 192 may be in contact with the elongate member 172. Thus, the connection between the first intermeshing member component 194 and the at least one second intermeshing member component 196 may be opened. The second interlocking member component 196 can accommodate the elongated member 196. Meanwhile, the receiving portion 190 of the release button 184 still locks the elongated member 172. This state is also depicted in FIG. 2B in detail.

In FIG. 3D shows a cross-sectional view of the drug delivery device 100. The drug delivery device 110 includes a first portion 112 containing a medical device 116. FIG. 3D, the first part 112 and the second part 114 are assembled. Thus, the body 122 may be aligned with the pad 138. Said receptacle 184 of the release button 184 may still retain the elongated element 172. Thus, the receptacle 190 of the release button 184 may receive the elongated element 172. The elongated element 172 may be positioned between the first component 194 interlocking element and at least one second component 196 interlocking element. Thus, the first intermeshing element component 194 and at least one second intermeshing element component 196 may receive an elongated element 172. The first intermeshing element component 194 and the second intermeshing element component 196 may be configured to form a mechanical connection 216. This state is also depicted in fig. 3D in detail.

In FIG. 3E shows a cross-sectional view of the drug delivery device 110. The drug delivery device 110 includes a first portion 112 containing a medical device 116. FIG. 3D, the first part 112 and the second part 114 are assembled, and the integrated insertion mechanism 144 is started. Thus, the cannula 145 is in the inserted position 218.

The integrated insertion mechanism 144 can be configured to be triggered by a release button 184. Thus, by pushing the second end 188 in a direction transverse to the skin (not shown), as indicated by arrow 220, the first end 186, such as the receiving portion 190 may lower the elongated member 172. As a consequence, the spring member 168 may loosen in the insertion direction, as indicated by arrow 174. As a consequence, the drive unit 166 may move in the insertion direction. Since the interlocking member 194 can be fixedly connected to the drive unit 166, the elongate member 172 with the ex vivo end 202 of the cannula 145 is received into the protrusion 180 of the elongated member 172 also moving in the direction of insertion. The cannula 145, in particular, in vivo, the end 202 of the cannula 145 may pass through the port 208 and may be inserted into body tissue (not shown). As a consequence, fluid passage 182, which may be flexible, may transition from a bent configuration to an extended configuration. Thus, a hydraulic connection can be maintained between the container 146 and the cannula 145 through the fluid channel 182. This state is also depicted in FIG. 3G in detail view.

4A and 4B show an exemplary embodiment of the medical device 116 in various cross-sectional views. Medical device 116 partially corresponds to medical device 116 as shown in FIG. 1A-3G. Thus, reference can be made to the description above. The medical device 116 includes an overlay 138 and a cannula 145. In addition, the overlay 138 includes a container 146. More information about these components can be found in the above description.

The patch 138 also includes an integrated insertion mechanism 144. Additionally, the medical device 116 may include a drive unit 166. In the medical device 116 of FIG. 4A and 4B, the drive unit 166 can be movable in a direction parallel to the insertion direction, as indicated by arrow 222. Thus, the spring member 168 can be compressible in the insertion direction by the drive unit 166. Said ex vivo end 202 the cannula 145 may be fixedly attached to the element 224. The element 224 may be in direct contact with the bearing surface 226 of the drive unit 166.

In FIG. 4A, cannula 145 is in storage position 204. Thus, the cannula 145, in particular the in vivo end 206 of the cannula 145 is received in the patch 138. By moving the drive unit 166 in the direction of insertion, the element 224 can slide along the sliding guide of the receiving portion 176 of the patch 138. Thus, the cannula 145 can be driven into motion from the patch 138 to the inserted position 218 within the body tissue as shown in FIG. 4B. Element 224 may be received with a receptacle 228 that is located in close proximity to the bore 208. In particular, the element 224 may be configured to seal the receptacle 228.

In addition, by moving the drive unit 166 in the insertion direction, the spring member 168 can be tensioned. Thus, in the inserted position 218, the drive unit 166 can be pulled back by the tension force of the spring element 168 while the element 224 remains inside the receiving portion 228.

Reference Number List

110 drug delivery device

112 first part

114 second part

116 medical device

118 drug pump

120 electronic unit

122 building

124 free volume

126 wall

128 linear sliding mechanism

130 linear sliding receiving part

132 linear sliding guide rail

134 ledge

136 longitudinal axis

138 overlay

140 lining base

142 adhesive surface

143 plaster

144 integrated insertion mechanism

145 cannula

146 capacity

148 spring loaded insertion mechanism

150 cylindrical bottle

152 additional capacity

154 mixing device

156 static mixer

158 tube

160 piston

162 piston rod

164 drive spindle

166 drive unit

168 spring element

170 interior space

172 elongated element

174 arrow

176 sliding guide receiving part

178 linear sliding guide rail

180 ledge

182 fluid channel

184 release button

186 first end

188 second end

190 receiving part

191 external elements

192 interlocking element

194 first receiving part of the interlocking element

196 second receiving part of the interlocking element

198 snap lock

200 end

202 ex vivo end

204 storage position

206 in vivo end

208 through hole

210 cannula receptacle

211 wall

212 infusion cannula

214 pre-bent cannula

216 mechanical connection

218 inserted position

220 arrow

222 arrow

224 element

226 bearing surface

228 receiving part

Claims (22)

1. Medical device (116) for percutaneous insertion of a cannula (145) into body tissue, containing: - at least one cannula (145), while the cannula (145) contains a lumen, which is completely or partially limited by the wall (211) of the cannula (145); - at least one pad (138) made with the possibility of installation on the skin of the user, while the pad (138) contains at least one pad base (140), while the pad (138) additionally contains at least one integrated mechanism ( 144) for inserting to move the cannula (145) from the storage position (204) inside the pad (138) to the inserted position (218) inside the body tissue; wherein the patch (138) additionally comprises at least one container (146) configured to store at least one therapeutic medical fluid, and the integrated insertion mechanism (144) is a spring-driven insertion mechanism (148), moreover, the integrated mechanism (144) for insertion contains at least one drive unit (166) made for forced shifting of the cannula (145) in the direction of insertion, and at least one interlocking element (192) made for fixing the drive unit (166) in a fixed position, while the interlocking element (192) is fixedly connected to the drive unit (166) and contains a snap-on locking element (198). 2. The medical device (116) according to claim 1, wherein the cannula (145) is selected from the group consisting of: an insertion cannula for inserting the infusion cannula into body tissue; infusion cannula (212). 3. Medical device (116) according to claim 1 or 2, wherein the integrated insertion mechanism (144) is a sliding mechanism. 4. Medical device (116) according to any one of paragraphs. 1-3, wherein the medical device (116) is configured to be connected to at least one external element (191), wherein the integrated insertion mechanism (144) is configured to be driven by a force created by connecting the external element ( 191) with a medical device (116). 5. Medical device (116) according to any one of paragraphs. 1-4, wherein the integrated insertion mechanism (144) further comprises at least one spring element (168), wherein the spring element (168) is tensileable parallel to the insertion direction, wherein the drive unit (166) is configured to compression spring element (168). 6. Medical device (116) according to any one of paragraphs. 1-5, wherein the interlocking element (192) comprises at least one first component (194) of the interlocking element and at least one second component (196) of the interlocking element, wherein the first component (194) of the interlocking element and the second component (196) of the interlocking element are at least partially made of an elastic material, wherein the first component (194) of the interlocking element and the second component (196) of the interlocking element are configured to form a mechanical connection (216). 7. Medical device (116) according to any one of paragraphs. 1-6, moreover, the medical device (116) further comprises at least one elongated element (172) containing at least one protrusion (180), while the cannula (145) is fixedly received inside the receiving part of the protrusion (180), while the interlocking element (192) is configured to receive the elongated element (172). 8. Medical device (116) according to claim 7, wherein the integrated insertion mechanism (144) further comprises at least one release button (184), wherein the release button (184) is configured to hold the elongated element (172) in a predetermined position and for the subsequent descent of the elongated element (172). 9. Medical device (116) according to claim 7 or 8, wherein the base (140) of the pad contains at least one sliding guide receiving part (176), while the sliding guide receiving part (176) is made to at least partially receive the protrusion (180), while the protrusion (180) is slidable inside the sliding guide of the receiving part (176). 10. A device (110) for delivering a drug in the form of at least one therapeutic medical liquid to a user, comprising: - at least one first part (112), while the first part (112) contains at least one medical device (116) according to any one of paragraphs. 1-9; - at least one second part (114), while the second part (114) contains at least one drug pump (118), made with the possibility of hydraulic connection with the cannula (145), while the second part (114) additionally contains at least one electronic unit (120). 11. Device (110) according to claim 10, wherein the first part (112) is a disposable component and the second part (114) is a reusable component. 12. The device (110) according to claim 10 or 11, wherein the first part (112) and the second part (114) are configured to create at least one connection selected from the group consisting of: landing. 13. A method for percutaneous insertion of a cannula (145) into body tissue, comprising: a) providing a device (software) according to any one of paragraphs. 10-12; b) placing the first part (112) on the user's skin; c) assembly of the first part (112) and the second part (114) so that the first part (112) and the second part (114) create at least one connection selected from the group consisting of: press fit; d) triggering the integrated insertion mechanism (144), thereby moving the cannula (145) from the storage position (204) inside the patch (138) to the inserted position (218) inside the body tissue.

Images