Stand for infusion pump unit

Abstract

A holder (1) for an infusion pump unit is disclosed, wherein the holder (1) has a proximal side (23) and a distal side (21), wherein the distal side (21) has an infusion pump unit attachment structure (22) for attaching an initially separate infusion pump unit. The holder (1) comprises a holder base (2), a flow channel (3) for a liquid drug, and a pierceable septum (4), wherein the pierceable septum (4) covers an opening of the flow channel (3) and seals the flow channel (3), and wherein at least one internal piercing core of the pierceable septum (4) is movably mounted relative to the holder base (2).

Description

Technical Field

[0001] This invention relates to the field of supports for infusion pump units and infusion systems including supports. Background Technology

[0002] Continuous subcutaneous insulin infusion (CSII) is an established and therapeutically beneficial approach to treating diabetes. Under CSII, diabetic patients essentially carry a miniature infusion device in the form of an insulin pump, essentially continuously throughout the day and night. The insulin pump delivers a minimum amount of insulin in a substantially continuous manner according to a person-specific, typically time-varying, infusion schedule or protocol, providing the diabetic patient with the so-called basal amount of insulin needed to maintain normal or near-normal metabolism (particularly blood glucose levels). Typically, the basal dosing schedule follows a roughly circadian rhythm and is preset by a healthcare professional. Additionally, the insulin pump is designed to deliver larger doses of insulin on demand within short periods of time, known as boluses.

[0003] For years, insulin pumps have essentially been designed as battery-powered, standalone devices, roughly the size of a credit card. This size allowed them to fit in a trouser pocket, complete with a corresponding sleeve and strap (like a collar). These devices are connected to a subcutaneous infusion cannula via an infusion tubing typically 0.5m to 1.5m long. The syringe-like medication container, received by the device's compartment and the infusion tubing and cannula, is designed for single use and is replaced by the patient after a relatively short lifespan (usually a few days). In recent years, more sophisticated devices have emerged that can wirelessly connect to remote controls, standard computers (such as PCs and smartphones), or glucose measurement devices or continuous glucose monitors (CGMs). A typical commercially available, state-of-the-art system includes the ACCU-CHEK from Roche Diabetes Care. ® Combo Spirit infusion device and ACCU-CHEK ® Combo Aviva remote control and blood glucose meter.

[0004] Primarily to improve comfort and discretion in application, alternative devices and systems have been developed and put into use in recent years. While these devices operate on the same technical principles, they are designed as patch devices that adhere directly to the infusion site. Furthermore, to avoid requiring additional tubing between the infusion device and the infusion cannula, the infusion site (usually the abdominal area) is typically covered with cloth, thus allowing the device to be carried in a particularly separate manner in most daily life situations.

[0005] These devices are fully integrated, single-use devices that need to be discarded and replaced once the application time (which is primarily determined by the container volume and the permissible indwelling time of the infusion cannula) has elapsed. They also need to be replaced if the device is removed from the infusion site for other reasons, such as numerous sporting activities or showering requirements.

[0006] To improve cost efficiency, systems based on modular patches have been designed, allowing for selective replacement of components. Examples of such systems are disclosed in WO 2009 / 016635 A2, which relates to a system having a patch unit or liquid drug infusion device removably attached to a stent, wherein the stent is removably attached to the patient's skin. A subcutaneous infusion cannula is attached to the stent and fluid pair, and in operation to the patch unit. The patch unit itself may be two parts and includes a disposable drug container and a reusable dispensing mechanism and control circuitry. In addition to the general advantages associated with modular design, this architecture allows for temporary removal of the relatively sensitive patch unit, including the drug container, for example, during sports activities, while the less critical and robust stent remains attached to the skin. Summary of the Invention

[0007] In modular liquid drug infusion systems, a releasable fluid connection is typically established by puncturing a puncturable diaphragm using a cannula (such as a transfer cannula). The advantage of such diaphragms is that they avoid complex and expensive connection components. The diaphragm is typically made of an elastic material such as rubber or silicone, which tightly seals the flow path of the liquid drug. To connect the flow path to another device (e.g., an infusion pump unit), the diaphragm is punctured via a transfer cannula, creating a puncture path within the diaphragm on the transfer cannula. Due to the radial force applied by the cannula, the elastic diaphragm material is pushed against the outer wall of the transfer cannula, thus creating a tight seal between the cannula and the diaphragm. After the cannula is disconnected from the infusion pump unit, the puncture path typically reseals completely due to the elastic properties of the diaphragm. However, upon reconnection, i.e., during an additional puncture event, a second puncture path is created because the user often cannot accurately identify and / or follow the previous puncture path. Typically, the diaphragm's sealing performance deteriorates significantly with each additional puncture event, and the occurrence of leakage represents a serious problem.

[0008] Furthermore, the septum is typically not pierced in a straight line and is usually not perpendicular to the puncture surface of the septum. Sometimes, perpendicular puncture is simply impossible because the transfer cannula is manually introduced, and the user cannot provide the necessary precision for septal puncture. Additionally, several devices with relatively flat designs have been developed to increase wearing comfort and reduce their visibility when attached to the patient's skin. In these devices, the septum is pierced along a puncture path that is inclined relative to the puncture surface of the septum. Piercing the septum in this manner can have detrimental effects on its sealing behavior. For example, in these cases, no radially symmetrical force is applied to the cannula, which reduces the seal between the cannula and the septum. Therefore, some areas of the septum exhibit different forces than others, potentially leading to areas subjected to tensile effects and areas subjected to compressive effects. Additionally, the lateral force applied to the septum by the cannula during penetration may superimpose with the radially symmetrical force, resulting in asymmetrical pressure acting on the cannula. Furthermore, after cannula removal, optimal sealing of the perforation path can only be achieved by piercing the septum in a strictly perpendicular manner and along a straight perforation path.

[0009] Furthermore, due to design constraints of latching devices, such as those used in infusion pump units and supports, and / or due to inaccuracies associated with manual, unguided diaphragm puncture, a puncture event can be performed as a pivoting movement of the cannula. Consequently, some areas within the diaphragm are stretched, while others are compressed by the pivoting puncture movement of the cannula. These stretching and compression effects reduce the sealing behavior of the diaphragm and thus represent an additional source of leakage.

[0010] Therefore, the overall objective of this invention is to improve the technical level of the design of stents for infusion pumps in the case of infusion and / or injection of liquid drugs, thereby preferably completely or partially avoiding the disadvantages of the prior art.

[0011] In an advantageous embodiment, a support is provided that ensures the diaphragm is punctured perpendicular to its puncture surface and / or ensures the diaphragm is punctured along a straight perforation path.

[0012] In a further advantageous embodiment, the bracket for the infusion pump unit has enhanced sealing performance.

[0013] The overall objective is generally achieved through the subject matter of the independent claims. Further advantageous and exemplary embodiments are derived from the dependent claims, the specification, and the drawings.

[0014] According to a first aspect of the invention, the overall problem is solved by a stent for an infusion pump unit, wherein the stent has a proximal side and a distal side. The distal side has an infusion pump unit attachment structure for attaching an initially separated infusion pump unit. The stent includes a stent base, a flow channel for a liquid drug, and a puncturable diaphragm. The puncturable diaphragm covers the opening of the flow channel and seals the flow channel in the separated state of the stent and the infusion pump unit. At least one internal puncture core of the puncturable diaphragm is movably mounted relative to the stent base.

[0015] As used herein, the term "diaphragm" is readily understood by those skilled in the art and is generally an engineered element, such as in the form of a membrane or plunger, used to sealably separate a first side and a second side in a fluid (i.e., a tight seal of gas and / or liquid), which can be punctured by a cannula. Typically, the diaphragm does not include an opening or puncture through it from the first side to the second side until the cannula has punctured it. Therefore, the diaphragm cannot be easily punctured by residual cannula without applying considerable force. Thus, the diaphragm seals the flow passage, yet allows penetration by the cannula to establish a fluid connection.

[0016] Typically, the stent base is rigid or substantially rigid and may be made of plastic material. The stent base is usually flat, disc-shaped, or elongated. Furthermore, the stent base may be defined by a horizontal plane that includes the disc-shaped or elongated stent base and is in an operating position parallel to the patient's skin.

[0017] In a typical embodiment, the flow channel of the stent can be fluidly connected to a fluid connector, tubing equipped with an infusion cannula, or tubing equipped with a fluid connector. For example, such a connection can be established using a Luer connector or a suitable proprietary fluid connector. In a further embodiment, the infusion tubing is directly and permanently connected to the stent base in a manner that fluidly connects it to the flow channel. In such embodiments, the tubing is an integral and inseparable part of the stent.

[0018] A puncturable diaphragm typically includes an internal puncture core. While in some embodiments the diaphragm is substantially composed of the internal puncture core, in other embodiments the diaphragm may include the internal puncture core and other portions, such as a sealing ring surrounding the internal puncture core. However, in all embodiments, the internal puncture core of the diaphragm is movably mounted relative to the stent base. It should be understood that the term "movably mounted" refers to a movement in which the internal puncture core is moved as a whole. Therefore, partial movement of only a portion of the internal puncture core of the diaphragm core in this case does not represent movement. Thus, at least the internal puncture core or the puncturable diaphragm itself is also movably mounted as a whole relative to the stent base. This avoids any asymmetrical forces that might be applied to the cannula during puncture. Furthermore, the movable internal puncture core ensures that the diaphragm is punctured along a straight puncture path, thereby providing enhanced sealing performance for the diaphragm. Additionally, such a stent allows for an increased number of engagement and disengagement events between the stent and the infusion pump unit.

[0019] In a further embodiment, the proximal side has a skin attachment member for releasably attaching the stent to the patient's skin. The skin attachment member may be, for example, an adhesive tape, an adhesive layer, an adhesive patch, etc.

[0020] In some embodiments, the diaphragm can be punctured and sealed to the support base by clamping or crimping. For example, while maintaining the crimping force, the periphery of the diaphragm can be heated, deformed, and subsequently cooled. Thus, a prestress, preferably radial prestress, can be applied to the diaphragm using a force acting on its central axis.

[0021] In some embodiments, at least the internal puncture core or the entire puncture-prone septum may also be movable in the lateral direction of the stent base and / or tiltable relative to the horizontal plane of the stent base. The horizontal plane of the stent base is in an operational state substantially parallel to the patient's skin. Thus, in a typical embodiment where the stent is flat and elongated or flat and disc-shaped, the stent is primarily arranged within the horizontal plane. The lateral direction is any direction within the horizontal plane. Typically, the lateral direction is parallel to the puncture surface of the septum, i.e., the septum surface punctured during the establishment of a fluid connection. Such embodiments are advantageous because even when the cannula approaches the septum at an angle not strictly perpendicular to the puncture surface, the septum is tilted relative to the horizontal plane of the stent base when the transfer cannula of the infusion pump unit contacts the puncture surface of the septum before the cannula penetrates the septum. For example, if the transfer cannula of the pump unit approaches the puncture surface of the septum at an angle of 60°, the septum tilts upon contact with the needle, such that the puncture angle is substantially 90°, thus forming a straight puncture path. This ultimately improves the sealing behavior of the diaphragm because the force applied to the cannula during puncture is radially symmetrical.

[0022] In some embodiments, the puncturable diaphragm includes a circumferential sealing ring, an internal puncture core, and a deformable strip. The internal puncture core and the circumferential sealing ring are typically circumferentially connected by a deformable strip arranged radially between them. The strip is configured such that the internal puncture core of the diaphragm is movable relative to the stent base and / or relative to the sealing ring of the diaphragm. Preferably, the deformable strip is configured such that the internal puncture core of the diaphragm is movable in the transverse direction of the stent base and / or tiltable relative to the horizontal plane of the stent base. On the one hand, the strip thus allows the internal puncture core of the puncturable diaphragm to move, and on the other hand, allows the airtight and / or liquid-tight diaphragm to seal the flow channels of the stent. The strip is typically thin, i.e., 0.1 mm to 5 mm, preferably 0.1 mm to 2.5 mm. Furthermore, the strip may be made of an elastomer or a thermoplastic elastomer.

[0023] In a typical embodiment, the circumferential sealing ring, the deformable strip, and the internal puncture core of the puncture-resistant diaphragm are integrally formed. Typically, they are made of the same elastic material.

[0024] In such embodiments, preferably, a sealing ring surrounding the internal puncture core of the puncture-resistant diaphragm is connected to the support base by crimping or clamping. The area occupied by the sealing ring, and thus the entire area occupied by the diaphragm, can be circular, but can also have different shapes, such as rectangular, cubic, triangular, pentagonal, or hexagonal. However, in all embodiments, the sealing ring is circumferentially closed.

[0025] In some embodiments, the stent includes a stop configured to limit movement of the internal puncture core within the diaphragm. Typically, the stop is positioned below the diaphragm. Thus, the stop is arranged such that vertical movement of the internal puncture core is only permitted to reach a predefined deflection relative to a stress-free rest position. The stop is typically designed to provide a reaction force against the puncture force. Therefore, the internal puncture core remains movable or tiltable, but the accuracy of the puncture is improved due to the applied reaction force. Furthermore, breakage of the typically thin band, which could be caused by excessive vertical deflection of the internal puncture core during the puncture event, is prevented.

[0026] The stopper may be, for example, a widened or stepped portion within the flow channel, or a circular or rod-shaped support, a support lip within the flow channel, or a toothed object extending into the flow channel.

[0027] In some embodiments, the stent includes a pivotable arm that at least partially includes a flow channel. A puncturable diaphragm is disposed on the pivotable arm. Preferably, the pivotable arm has at least a cylindrical shape. The puncture surface of the diaphragm is substantially parallel to at least a portion of the pivotable arm. Thus, the pivotable arm may preferably be L-shaped. The arm is generally pivotable in the lateral direction of the stent base, i.e., pivotable within the horizontal plane of the stent base. The advantage provided by these embodiments is that any local stretching or compression of at least the internal puncture core of the diaphragm or the entire diaphragm (which can be achieved along an inclined puncture path) can be compensated for by the lateral movement of the pivotable arm. Furthermore, the pivotable arm may be pivotable to a certain extent relative to the horizontal plane of the stent base, i.e., the arm may pivot out of the horizontal plane of the stent base, which can further improve the sealing behavior of the diaphragm.

[0028] In some embodiments with a rotatable arm, the rotatable arm is pivotable in the lateral direction of the support base and / or pivotable out of the horizontal plane of the support base.

[0029] According to another aspect of the invention, the overall problem is solved by a stent for an infusion pump unit, wherein the stent has a proximal side and a distal side, the distal side having an infusion pump unit attachment structure for attaching an initially separated infusion pump unit. Furthermore, the stent includes a stent base, a flow channel for a liquid drug, and a puncturable septum covering and sealing the opening of the flow channel. The stent also includes a guide device for providing a linear guiding path. The guide device is disposed on the distal side of the stent and surrounds the flow channel and the puncturable septum. The guide device is movable along the puncture axis of the puncturable septum between an initial position and an operating position.

[0030] The puncture axis is usually transverse to, or more specifically perpendicular to, the puncture surface of the diaphragm. However, the puncture axis can also have different angles.

[0031] Typically, the flow channel can be formed by a tubular portion of the support base. Furthermore, the guide device is at least partially movable along the flow channel. The guide device is typically configured to provide a linear guide path for connecting the support to the infusion pump unit via a transfer cannula.

[0032] Therefore, the guide device ensures that the diaphragm is punctured along a linear guide path, thus providing enhanced sealing performance. Furthermore, the diaphragm can always be precisely punctured at the same location because the guide device provides a linear guide path and avoids any deflection relative to the guide path, particularly any deflection in the lateral direction of the support base. Thus, the diaphragm is always punctured at the same location and multiple puncture sites are avoided, which ultimately increases the tightness of the diaphragm seal and allows for a greater number of connection and disconnection events between the support and the infusion pump unit.

[0033] In a further embodiment, the proximal side has a skin attachment member for releasably attaching the stent to the patient's skin, as further explained above and below in the context of the exemplary embodiments.

[0034] In some embodiments, in the initial position, the guide extends from the flow channel and the punctureable septum. Such embodiments are advantageous because the guide prevents an approaching cannula from puncturing the septum in the initial position. Before the guide moves to the operating position, it provides a linear perforation path, preferably transverse to, and particularly perpendicular to, the puncture surface of the septum.

[0035] Typically, the guide device can extend 0.5 mm to 20 mm from the puncture surface of the diaphragm in its initial position.

[0036] In some embodiments, the guide device is tubular. Furthermore, the internal design of the guide device allows it to surround and be tightly fitted around the flow channel and the puncture-resistant diaphragm.

[0037] In some embodiments, the guide device is slidably movable between an initial position and an operating position. Therefore, during the connection event between the stent and the infusion pump unit, the guide device first contacts the infusion pump unit, allowing the transfer cannula to penetrate and / or contact the diaphragm. The guide device then provides a linear guide path along which the transfer cannula moves to penetrate the diaphragm. When the user pushes the stent and the infusion pump unit toward each other, the guide device slides between the initial and operating positions, thereby allowing the transfer cannula to penetrate the diaphragm.

[0038] In a preferred embodiment, the guide device includes a cutout to allow movement along at least a portion of a curved or tortuous flow channel, particularly an L-shaped flow channel.

[0039] According to another aspect of the invention, the overall problem is solved by an infusion system comprising a support according to the invention as described in any of the above embodiments and an infusion pump unit with a transfer cannula. The support and the infusion pump unit are releasably connected, particularly via a pump unit attachment structure of the support and corresponding, respectively complementary support attachment structures of the infusion pump unit.

[0040] It should be understood that in the initial state, the support and the infusion pump unit are not connected, while in the operating state, the support and the infusion pump unit are connected. That is, a fluid connection is established between the flow channels of the infusion pump unit and the support.

[0041] In some embodiments, the infusion system includes a support with a guide as described in any of the above embodiments, wherein, in the initial position, the guide prevents the transfer cannula of the infusion pump unit from puncturing the diaphragm before the diaphragm and the transfer cannula are aligned in a predefined state. In the operating position, the transfer cannula can penetrate the diaphragm substantially perpendicular to the puncture surface of the diaphragm.

[0042] In some embodiments, the infusion system includes a support with a guiding device as described in any of the above embodiments, wherein, in the initial position, the puncture surface of the diaphragm and the transfer cannula of the infusion pump unit are arranged substantially perpendicular to each other and / or the transfer cannula is arranged above the central region of the puncture surface of the diaphragm. This ensures that the diaphragm is always punctured at the same location, thereby avoiding multiple perforation sites in cases where the infusion pump unit and support are connected and disconnected more than once. Consequently, the number of connection and disconnection events may increase significantly before leakage occurs or becomes a serious problem.

[0043] In a preferred embodiment, the infusion system includes a support with a guide as described in any of the above embodiments, and the guide is configured to prevent any lateral relative movement between the cannula and the diaphragm in the operating position.

[0044] In a typical embodiment, the transfer cannula of the infusion pump unit is arranged within a recess, which preferably has a shape corresponding to the guide device. In some embodiments, the recess may also be tubular. Therefore, the guide device can be arranged within the recess in the operating position. Such embodiments are particularly advantageous because the guide path provided by the guide device is linear and perpendicular to the puncture surface of the diaphragm.

[0045] According to another aspect of the invention, the overall problem is solved by a puncturable diaphragm comprising a circumferential sealing ring, an internal puncture core, and a deformable strip. The sealing ring and the internal puncture core are connected by the deformable strip. The strip is configured such that the internal puncture core of the diaphragm is movable relative to the sealing ring of the diaphragm. Preferably, the deformable strip is configured such that the internal puncture core of the diaphragm is movable in the lateral direction, i.e., toward a portion of the sealing ring of the diaphragm, and / or is tiltable relative to the horizontal plane of the diaphragm. It should be understood that the horizontal plane of the diaphragm is arranged perpendicular to the outer wall of the sealing ring and perpendicular to the puncture axis of the diaphragm. On the one hand, the strip thus allows the internal puncture core of the puncturable diaphragm to be movable, and on the other hand, allows the airtight and / or liquid-tight diaphragm to seal the flow channels of the stent. The diaphragm according to this aspect may in particular be the diaphragm of the embodiments discussed above in the context of the stent and / or the diaphragm of the embodiments further discussed in the context of the exemplary embodiments below, and the corresponding disclosure should also be understood to refer to such a diaphragm. Attached Figure Description

[0046] Figure 1 shows a plan view of a support for an infusion pump unit according to a first embodiment of the present invention.

[0047] Figure 2 shows a partial view of a support for an infusion pump unit according to another embodiment of the present invention.

[0048] Figure 3 shows a cross-sectional view of a support for an infusion pump unit according to another embodiment of the present invention.

[0049] Figure 4 shows a plan view of a support for an infusion pump unit according to another embodiment of the present invention.

[0050] Figure 5 shows a plan view of a support for an infusion pump unit according to another embodiment of the present invention.

[0051] Figure 6 shows a guide device for a support for an infusion pump unit according to another embodiment of the present invention.

[0052] Figure 7 shows a cross-sectional view of a support for an infusion pump unit according to another embodiment of the present invention.

[0053] Figures 8a to 8c show cross-sectional views of a support for an infusion pump unit according to another embodiment of the present invention at different stages of establishing a connection with the infusion pump unit. Detailed Implementation

[0054] Figure 1 illustrates an advantageous embodiment of a stent for an infusion pump according to the invention. A top view of the stent 1, seen from the distal side 21, is shown, wherein the distal side 21 has an infusion pump unit attachment structure 22 for attaching an initially separated infusion pump unit. The stent 1 includes a stent base 2 and a puncturable diaphragm 4 that covers an opening for a flow channel for a liquid drug. A pivotable arm 6 at least partially includes the flow channel for the liquid drug (see Figure 2). The puncturable diaphragm 4 is movably mounted relative to the stent base 2 via the pivotable arm 6. The puncture surface of the diaphragm 4 is arranged substantially parallel to the horizontal plane H of the stent base 2. Therefore, at least a portion of the flow channel is transverse to the diaphragm 4. As can be seen in Figure 1, the diaphragm 4 is arranged on the pivotable arm 6 and thus seals the flow channel, which is at least partially arranged within the pivotable arm 6. The pivotable arm 6 allows the diaphragm or at least its inner core to be movable in the lateral direction of the support base 2 and / or tiltable relative to the horizontal plane H of the support base 2. Furthermore, the pivotable arm 6 is pivotable in the lateral direction of the support base 2. It is readily understood that any lateral direction lies within the horizontal plane H of the support base.

[0055] Figure 2 shows a partial view of a stent 1 according to another embodiment of the present invention. As shown in Figure 1, the stent includes a stent base 2, a diaphragm 4, and a pivotable arm 6. Additionally, the diaphragm 4 includes an internal puncture core 41 movably mounted to the stent base. Figure 2 further depicts a flow channel 3, which is at least partially arranged within the pivotable arm 6. The internal puncture core 41 of the diaphragm 4 is independently movable relative to the pivotable arm 6 and the stent base 2.

[0056] Figure 3 illustrates, for example, according to Figure 2 A detailed view of the diaphragm 4 used in the stent, the diaphragm comprising an internal puncture core 41 and a circumferential sealing ring 42 connected by a deformable band 43. It can be seen that the band 43 allows the internal puncture core 41 to move independently when the circumferential sealing ring 42 is fixedly attached to the stent base or pivotable arm. The diaphragm 4 further comprises a substantially flat puncture surface punctured by a cannula when a fluid connection is established. The diaphragm 4 covers the opening of the flow channel 3 for liquid medication and thus seals the flow channel. The diaphragm shown in FIG. 3 is sealed to the stent base or pivotable arm by crimping the circumferential sealing ring 42. This embodiment is particularly advantageous because the internal puncture core is movable both by tilting relative to the horizontal plane of the stent base and by lateral movement (i.e., by changing the distance from the circumferential sealing ring 42). Therefore, if the cannula approaches the internal puncture core 41 in a non-perpendicular manner, the internal puncture core is tilted relative to the horizontal plane of the stent base upon contact with the cannula prior to the puncture event itself. Thus, the internal puncture core 41 is always punctured laterally, preferably vertically, relative to the puncture surface. Furthermore, any pivotal movement of the cannula during the puncture event can be compensated for by the lateral movement of the internal puncture core. Therefore, any harmful tensile or compressive effects within at least the internal puncture core of the septum are prevented or at least reduced. Additionally, the stent includes a stop 5 configured to limit the vertical movement of the internal puncture core 41 of the septum. Therefore, when the cannula punctures the septum 4, the vertical force exerted by the cannula on the septum pushes the internal puncture core 41 against the stop 5 and may abut against it. Thus, the stop provides a reaction force against the puncture force of the cannula. As can be seen, the stop is positioned at a predetermined distance below the lower surface of the inner puncture core 41 to allow for a predefined vertical deflection of the diaphragm. In this case, the stop is simply designed to widen at the opening of the flow channel 3.

[0057] Figure 4 illustrates a stent 1 for an infusion pump unit according to another embodiment of the invention. The stent 1 has a distal side 21 with an infusion pump attachment 22 for attaching an initially separated infusion pump unit. The stent 1 further includes: a stent base 2; a flow channel for a liquid medication (not shown, see Figure 6); and a puncturable septum (not shown, see Figure 6) that covers and seals the flow channel. Furthermore, the stent 1 includes a guide device 7 for providing a linear guiding path. As can be seen in Figure 4, the guide device 7 is arranged on the distal side 21 of the stent base 2. The guide device 7 has a tubular shape and surrounds the flow channel and the puncturable septum. In the initial position shown in Figure 4, the guide device 7 extends from the flow channel and the puncturable septum. Therefore, when the stent 1 is connected to the infusion pump unit via a transfer cannula configured to extend into the puncturable septum of the stent 1, the guide device 7 contacts the infusion pump unit before a puncture event. In this position, guide device 7 prevents puncture because the protruding portion of the guide device is longer than the puncture portion of the transfer cannula. When the puncture surface of the diaphragm is substantially perpendicular to the transfer cannula of the infusion pump unit, guide device 7 can be moved to the operating position, in which the cannula can puncture the diaphragm.

[0058] Figure 5 shows a plan view of a stent according to an advantageous embodiment of the invention. The stent 1 is shown in a plan view on the proximal side 23. For releasable attachment to the patient's skin, the proximal side 34 has a skin attachment member 24, which is illustratively implemented as an adhesive sheet.

[0059] Figure 6 shows a detailed view of the guide device 7 used in some embodiments of the invention. It can be readily seen that the guide device 7 has a tubular shape and includes a cutout 71 that allows the guide device to slide along at least a portion of a curved, tortuous, particularly L-shaped flow channel (see below).

[0060] Figure 7 shows the stent 1 for the infusion pump unit 8 before the stent 1 and the infusion pump unit 8 are connected to form a connected infusion system. The stent 1 includes a proximal side 23 and an L-shaped flow channel 3 for liquid medication. The opening of the flow channel 3 is covered and sealed by a puncturable septum 4. The stent 1 further includes a guide 7 with a notch 71. The guide surrounds the flow channel 3 and the puncturable septum 4. In the initial state shown, the guide 7 extends from the flow channel 3 and the septum 4. The infusion pump unit includes a transfer cannula 81 configured to establish a fluid connection with the flow channel 3 of the stent 1 upon puncture of the septum 4. The guide is configured to provide a linear guide path along the puncture axis A.

[0061] Figures 8a and 8c illustrate the connection of the support 1 and the infusion pump unit 8 according to the invention to form a connected infusion system 9. Figure 8a shows the initial position of the support 1, with the guide 7 extending from the flow channel 3 and the puncturable diaphragm 4 around the L-shaped flow channel 3. It can be readily seen that the transfer cannula 81 of the infusion pump unit 8 is arranged in a recess whose shape corresponds to the shape of the guide 7. It should be understood that the guide 7 shown in Figure 8a ensures that the diaphragm is punctured laterally, and particularly vertically, relative to its puncture surface.

[0062] When the support 1 and the infusion pump unit 8 are pushed toward each other, the guide device 7 is inserted into the recess of the infusion pump unit. In the intermediate state shown in Figure 8b, the guide device has not yet moved along the flow channel, but it is in contact with the infusion pump unit 8. Due to the fact that the guide device 7 extends from the puncturable diaphragm 4 and the flow channel 3, the guide device prevents the diaphragm 4 from being punctured before a straight, transverse, and especially vertical guide path relative to the puncture surface of the diaphragm is established along the puncture axis A.

[0063] As the support 1 and the infusion pump unit 8 are further pushed together, the guide device 7 moves to the operating position shown in FIG. 8c. Therefore, the guide device 7 moves relative to the diaphragm 4 and the flow channel 3, causing the protrusion to gradually decrease, thereby allowing the transfer cannula 81 to penetrate the diaphragm 4 and establish a fluid connection between the infusion pump unit and the flow channel 3 of the support 1. The cut 71 of the guide device 7 ensures that the L-shaped shape of the flow channel 3 does not impede the movement of the guide device along the flow channel 3. Therefore, the infusion system can be designed in a relatively flat and discreet manner. It should be understood that, in the illustrated embodiment, the guide device further ensures that the diaphragm is always punctured at the same location, thereby avoiding multiple perforation sites.

[0064] Name List

[0065] 1. Bracket

[0066] 2. Support base

[0067] 21. Distal lateral aspect

[0068] 22. Attachment structure of the infusion pump unit

[0069] 23 Proximal lateral aspect

[0070] 24 Skin attachment components

[0071] 3. Flow channel

[0072] 4. Diaphragm

[0073] 41 Internal puncture core

[0074] 42 Sealing ring

[0075] 43. Strip-shaped material

[0076] 5. Stopper

[0077] 6. Pivotable arm

[0078] 7. Guiding device

[0079] 8 Infusion Pump Unit

[0080] 81 Transfer cannulation

[0081] 9. Infusion System

Claims

1. A bracket (1) for an infusion pump unit, wherein the bracket (1) has a proximal side (23) and a distal side (21), wherein the distal side (21) has an infusion pump unit attachment structure (22) for attaching an initially separated infusion pump unit; wherein the bracket (1) comprises: Support base (2); Flow channel (3), the flow channel being used for liquid drugs; as well as A puncturable diaphragm (4), wherein the puncturable diaphragm (4) covers and seals the opening of the flow channel (3), and wherein at least one internal puncture core of the puncturable diaphragm (4) is movably mounted relative to the support base (2); The internal puncture core of the puncturable septum (4) is movable in the lateral direction of the stent base (2) and tiltable relative to the horizontal plane (H) of the stent base (2).

2. The stent (1) according to claim 1, wherein the puncturable diaphragm (4) is sealed to the stent base (2) by clamping or pressing.

3. The stent (1) according to claim 1 or 2, wherein the puncturable diaphragm (4) comprises a circumferential sealing ring (42), the internal puncture core (41) and a deformable strip (43), wherein the sealing ring (42) and the internal puncture core (41) are circumferentially connected by the deformable strip (43).

4. The stent (1) according to claim 3, wherein the stent (1) includes a stop (5) wherein the stop (5) is configured to define the range of motion of the internal puncture core (41) of the diaphragm (4).

5. The stent (1) according to claim 1 or 2, wherein the stent (1) includes a pivotable arm (6), wherein the pivotable arm (6) at least partially includes the flow channel (3), and wherein the diaphragm (4) is disposed on the pivotable arm (6), and wherein the puncture surface of the diaphragm (4) is substantially parallel to at least a portion of the pivotable arm (6).

6. The bracket (1) according to claim 5, wherein the pivotable arm (6) is pivotable in the transverse direction of the bracket base (2) and / or pivotable out of the horizontal plane of the bracket base (2).

7. A support (1) for an infusion pump unit having a transfer cannula (81), wherein the support (1) and the infusion pump unit (8) are releasably connectable, wherein the support (1) has a proximal side (23) and a distal side (21), the distal side (21) having an infusion pump unit attachment structure (22) for attaching an initially separated infusion pump unit; wherein the support (1) comprises: Support base (2); Flow channel (3), the flow channel being used for liquid drugs; as well as The support (1) further includes a puncturable diaphragm (4) that covers and seals the opening of the flow channel (3), the support (1) further including a guide (7) for providing a linear guide path, wherein the guide (7) is disposed on the distal side (21) of the support (1), and wherein the guide (7) surrounds the flow channel (3) and the puncturable diaphragm (4); and wherein the guide (7) is movable between an initial position and an operating position along the puncture axis (A) of the puncturable diaphragm; In the initial position, before the diaphragm (4) and the transfer cannula (81) are aligned in a predefined state, the guide device (7) prevents the transfer cannula (81) of the infusion pump unit (8) from piercing the diaphragm (4), and in the operating position, the transfer cannula (81) can penetrate the diaphragm substantially perpendicular to the puncture surface of the diaphragm (4).

8. The support (1) according to claim 7, wherein in the initial position, the guide (7) extends from the flow channel (3) and the puncturable diaphragm (4).

9. The bracket (1) according to claim 7 or 8, wherein the guide device (7) is tubular.

10. The bracket (1) according to claim 7 or 8, wherein the guide device (7) is slidably movable between the initial position and the operating position.

11. An infusion system (9) comprising a support (1) according to any one of claims 1 to 10 and an infusion pump unit (8) having a transfer cannula (81), wherein the support (1) and the infusion pump unit (8) are releasably connected.

12. An infusion system (9) comprising a stent (1) according to any one of claims 7 to 10 and an infusion pump unit (8) having a transfer cannula (81), wherein in the initial position, the puncture surface of the diaphragm (4) and the transfer cannula (81) of the infusion pump unit (8) are arranged substantially perpendicular to each other and / or the transfer cannula (81) is arranged above the central region of the puncture surface of the diaphragm (4).

13. An infusion system (9) comprising a support (1) according to any one of claims 7 to 10 and an infusion pump unit (8) having a transfer cannula (81), wherein the guide device (7) is configured to prevent any lateral relative movement between the transfer cannula (81) and the diaphragm (4) in the operating position.

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