INFUSION SYSTEM WITH INFUSION PUMP AND CONNECTABLE PUMP MODULE

Description

[0001] The present invention relates to an infusion system with an infusion pump and an interchangeable, separate pump module, wherein the pump module can be arranged or is arranged in a receptacle of the infusion pump and comprises / has a piston-cylinder unit that can be operatively connected to a drive mechanism of the infusion pump, with a piston that is translationally movable in a cylinder, wherein the piston can be coupled to the drive mechanism by means of a coupling or dome structure operatively connected to the piston and a counter-coupling or counter-coupling structure designed for connecting engagement with the dome structure and operatively connected to the drive mechanism. General technical background

[0002] In infusion technology, peristaltic pumps and syringe pumps are commonly used to administer fluids to patients. Syringe pumps are generally used for applications requiring high dosing accuracy, as they allow for precise and well-defined fluid delivery. Peristaltic pumps are well-suited for applications requiring larger fluid volumes because their pumping technology allows for largely continuous delivery without discrete volume control. State of the art

[0003] In the prior art, there are known applications for infusion pumps where relatively high flow rates must be combined with high flow accuracy, which leads to significant problems. Syringe pumps have the disadvantage that the fluid volume they can pump is limited by the volume of the syringe used (cylinder volume). Peristaltic pumps, on the other hand, can achieve relatively large flow rates, but have the disadvantage of lower flow accuracy compared to syringe pumps. Particularly at low flow rates, their flow accuracy is not guaranteed due to the peristaltic movement of the tubing. Furthermore, the drive mechanism of a peristaltic pump is usually relatively large and heavy, and the flexing of the pump tubing caused by the peristaltic drive consumes a relatively large amount of energy.

[0004] The applicant's infusion system addresses the aforementioned problem. It includes a pump module with a piston-cylinder unit adapted for actuation by a drive mechanism of the infusion pump, and a valve device to interrupt, in the case of a pump delivery stroke, a connection between the piston-cylinder unit (acting as a fluid intermediate storage reservoir) and a supply port to a separate large fluid volume, and to release a connection between the piston-cylinder unit and a patient port. In the case of a pump suction stroke, the valve device also releases the connection between the piston-cylinder unit and the supply port to the separate large fluid volume, and to close the connection between the piston-cylinder unit and the patient port.The pump module, designed as a single-use item and separate from the infusion pump, is interchangeably installed in the multi-use infusion pump. This offers a significant advantage, particularly for home infusion systems, as it simplifies sterility during infusion. However, other important aspects must be considered when administering an infusion and using the infusion system, such as minimizing malfunctions and operating errors and ensuring the proper course of treatment.

[0005] US 2011 / 150680 A1 discloses an infusion system with an infusion pump and a separate, disposable, and therefore replaceable pump module, which is to be arranged in a receptacle of the infusion pump, wherein the pump module has a pump piston which can be coupled to a thrust drive rod of the infusion pump by means of hook elements.

[0006] US 2002 / 176788 A1 discloses an infusion system comprising an infusion pump and an interchangeable pump module, which is coupled to a counter-coupling structure of the infusion pump via a coupling structure and locked by a locking element.

[0007] Relevant prior art is also disclosed in WO 2016 / 176198 A1 and EP 0 110 276 A2. Brief description of the invention

[0008] Based on the problem explained above, the invention aims to eliminate the aforementioned disadvantages, in particular to provide an infusion system that enables particularly simple, user-friendly and safe coupling of the pump module to the infusion pump and ensures that the system can only be put into operation when the pump module is coupled to the infusion pump in the intended manner (i.e. correctly inserted into the receptacle on the side of the infusion pump), and preferably that the system cannot be easily taken out of service during an ongoing treatment.

[0009] This problem is solved according to the invention by an infusion system with the features of claim 1. Advantageous embodiments of the invention are the subject of the dependent claims.

[0010] A first aspect relates to an infusion system with an infusion pump and a separate, interchangeable pump module, wherein the pump module can be arranged / is arranged in a receptacle of the infusion pump and comprises a piston-cylinder unit, operatively connectable to a drive mechanism of the infusion pump, with a piston that is translationally movable in a cylinder, wherein the piston can be coupled to the drive mechanism by means of a coupling / coupling structure operatively connected to the piston and a counter-coupling / counter-coupling structure designed for connecting engagement with the coupling structure and operatively connected to the drive mechanism, wherein the infusion system has a locking element that, in a locking position, interlocks the coupling structure and the counter-coupling structure in the coupled state. The first aspect alone is not covered by the claimed invention.

[0011] In a second aspect (which may be combined with the first aspect), the invention relates to an infusion system with an infusion pump and an interchangeable pump module, wherein the pump module can be arranged in a receptacle of the infusion pump and comprises a piston-cylinder unit, operatively connectable to a drive mechanism of the infusion pump, with a piston that is translationally movable in a cylinder, wherein the piston can be coupled to the drive mechanism by means of a dome structure operatively connected to the piston and a counter-coupling structure designed for connecting engagement with the dome structure and operatively connected to the drive mechanism, wherein the infusion pump has a control cam which is operatively connected to the pump module in such a way that, when the pump module is arranged in the receptacle as intended, it is forcibly positioned in a release position, pump position, or infusion position in which a pumping action of the piston is possible.and that, if the pump module is not arranged in the housing as intended, it is forcibly positioned in a locked or decoupling position in which a pumping action of the piston is not possible.

[0012] In a third aspect (which may be combined with the first and / or second aspect), the invention relates to an infusion system with an infusion pump and an interchangeable pump module, wherein the pump module can be arranged in a receptacle of the infusion pump and comprises a piston-cylinder unit, operatively connectable to a drive mechanism of the infusion pump, with a piston that is translationally movable in a cylinder, wherein the piston can be coupled to the drive mechanism by means of a dome structure operatively connected to the piston and a counter-coupling structure designed for connecting engagement with the dome structure and operatively connected to the drive mechanism, wherein the infusion system has a locking element which, in a locking position, interlocks the dome structure and the counter-coupling structure in the coupled state, and wherein the infusion pump has a control cam which is operatively connected to the pump module in such a way thatthat it is forcibly positioned in a release position when the pump module is arranged in the receiver as intended, wherein the infusion system has a locking element which, in a locking position, interlocks the dome structure and the counter-dome structure in the coupled state.

[0013] Advantageous embodiments of the invention are claimed in the dependent claims and are explained in more detail below.

[0014] A preferred embodiment of the infusion system is characterized in that the infusion pump has a cover element. This cover element can be positioned, in particular, in a closed position that seals the receptacle for the pump module (and in an open position that releases the receptacle). The cover element, the receptacle, and the pump module are preferably coordinated and designed such that the cover element cannot be positioned in the closed position if the pump element is not correctly arranged in the receptacle. In this way, the user receives feedback before starting the pump as to whether the pump module is correctly arranged in and connected to the infusion pump.

[0015] In a further preferred embodiment, the cover element is operatively connected to the control cam. The operative connection is preferably designed such that, when the cover element is in the closed position, it is forcibly positioned in the release position, and when the cover element is not in the closed position, it is forcibly positioned in the locking position. The operative connection can be implemented, in particular, via a mechanism, especially a toggle lever mechanism. It can, in particular, have a first lever arm and a second lever arm connected to each other via a free joint. One of the lever arms can be substantially L-shaped. Furthermore, one of the lever arms can be pivotably arranged on the infusion pump, in particular by means of a fixed pivot joint arranged on its housing. The toggle lever mechanism can also be equipped with an actuating rod (cam or similar) that interacts with the cover element.The remaining of the two lever arms is preferably rotatably coupled to the control cam at its end opposite the other lever arm.

[0016] According to a further preferred embodiment, the locking element, which may be in particular in the form of a preferably substantially hollow cylindrical clamping sleeve, is operatively connected to the control cam. This operative connection is preferably designed such that the locking element secures the coupling structure and the counter-coupling structure when the control cam is in the release position and releases the coupling structure and the counter-coupling structure when the control cam is in the locked position. For example, the control cam may have a control groove. Preferably, this groove comprises a release section extending in the longitudinal direction L and a locking section that is initially inclined and then extends transversely to the longitudinal direction L.In this case, the locking element has at least one, preferably two diametrically opposed control cams that engage in the control groove of the control cam, so that the locking element can be positioned between a locking position or clamping position and a release position by a relative positioning of the control cam as a result of the engagement described above.

[0017] A preferred embodiment of the invention is characterized in that the infusion system, in particular the infusion pump, has a toggle lever mechanism. This is operatively connected to the pump module, in particular via a coupling to the cover element. It is also operatively connected to the control cam, for example by being pivoted to the control cam.

[0018] The control mechanism can be pre-tensioned, particularly in the locking / disengaging position, for example by means of a spring element such as a bending spring, compression spring, or tension spring. This ensures that pumping is impossible if the pump module is not connected as intended.

[0019] According to a preferred embodiment of the invention, the locking element is designed as a sleeve-shaped hollow body. The longitudinal axis of the locking element / hollow body is preferably aligned parallel to, and in particular congruent with, the piston axis. Furthermore, the locking element is preferably positionable relative to the coupling structure and counter-coupling structure in the direction of the piston axis between the locking position and a release position.

[0020] The locking element is preferably pre-tensioned into the locking position, for example by means of a spring element such as a bending spring, compression spring or tension spring. This ensures that, when properly installed in the infusion pump housing, the pump module is always securely coupled to its drive and that accidental disconnection can be reliably prevented.

[0021] The infusion pump drive can, in particular, comprise a drive rod and a coupling rod, and be mechanically coupled to the piston of the piston-cylinder unit via these. Preferably, all these elements are arranged along the longitudinal axis of the piston-cylinder unit. The drive rod and / or the coupling rod can be permanently coupled to each other and to the drive. They are therefore not intended to be disconnected from it by the user. The drive rod is preferably driven translationally and can consequently perform a back-and-forth movement along the longitudinal axis L. The coupling rod can have a counter-coupling structure at its distal end, which is designed to match the dome structure of the piston. The counter-coupling structure can, in particular, have a circumferential recess or groove that is suitable and designed for coupling engagement with the piston's coupling hook.The locking element is preferably positioned relative to the coupling rod in the direction of the longitudinal axis L between a distal clamping position and a proximal release position. In the clamping position, it engages the mating dome and counter-dome structures, preventing them from separating and thus securing the connection between the piston / pump module and the drive / infusion pump. In the release position, the locking element releases the dome and counter-dome structures, allowing the user to easily remove the pump module from its housing.

[0022] A particularly user-friendly and safe embodiment of the infusion system is preferably characterized by an emergency release mechanism with an actuating element coupled to the locking element. The actuating element allows the locking element to be manually actuated and moved from the locked position to a release position. It is particularly advantageous if the actuating element is coupled to the control cam in such a way that it is blocked when the control cam is in the release position and cannot be actuated to move the locking element from the locked position to a release position. In this way, decoupling of the pump module and infusion pump during use due to accidental actuation of the emergency release can be reliably prevented.

[0023] The infusion pump's receptacle for the pump module can, for example, be designed as a recess in a pump housing and can be closed, in particular, by means of a cover element or closure (for example, a hinged closure flap mounted on the pump, especially on its housing). The cover element can be locked to the housing part via a locking mechanism, particularly in a position that closes the receptacle. The closure, the receptacle, and the pump module can be coordinated in such a way that closing (and, if applicable, locking) the receptacle is only possible if the pump module is correctly and properly positioned and connected. This provides the user with feedback regarding the correct setup and use of the pump, thus advantageously increasing patient safety.

[0024] Furthermore, closing the cover element can automatically couple the piston-cylinder unit to the drive, resulting in particularly simple and safe operation. The infusion pump housing can consist of a lower housing section, which houses and supports all the mechanical and electronic components, and an upper housing section, which may include a display and various control elements. A locking mechanism for the closure flap may be located inside the housing.

[0025] The piston can be arranged, in particular, on a connecting rod, especially preferably at one end of the connecting rod facing the two hose sections. The other end of the connecting rod can protrude from the cylinder. The piston can, in particular, be longer than the maximum fill level of the cylinder. This prevents ambient air, which is naturally located outside the cylinder, from mixing with the medium inside the cylinder. The combination of two sealing lips and the piston / cylinder length creates an effective barrier against penetrating germs. Preferably, the piston of the piston-cylinder unit is sealed on both sides by means of a proximal and a distal seal. This seals both negative and positive pressure movements of the piston to ensure the sterility of a fluid chamber / metering chamber, i.e., the space in which the fluid to be pumped is located within the cylinder.The pump thus meets the stringent cleanliness requirements of medical environments. The proximal and distal seals are advantageously parallel to each other. Since the piston has a largely circular cross-section, this results in approximately annular seals. The distance between the proximal and distal seals is specifically designed to be greater than the stroke of the piston-cylinder unit. This ensures that the metering area is in contact only with the piston and its sterile sealing lip, thereby preventing contamination of the fluid chamber / metering chamber due to excessive stroke movements.

[0026] In a preferred embodiment, the piston-cylinder unit has a coupling element for detachable coupling with a corresponding counterpart of an infusion pump drive. This coupling element can be arranged or formed directly on the piston. For example, the coupling element can be designed as a plug-in coupling to match the counterpart coupling structure and be automatically or necessarily coupled to the drive when the pump module is properly installed in the infusion pump. Preferably, the coupling has locking mechanisms that hold both coupling elements together and, in particular, enable the two coupling elements to lock into place in a way that is audible and / or tactile for the user.

[0027] The piston-cylinder unit is preferably a low-friction unit to minimize actuation forces and achieve high conveying accuracy. This can be achieved, for example, by providing the piston with seals on both sides in the axial direction, thus sealing it against the cylinder. In particular, the piston-cylinder unit can be designed in the form of a syringe with a low-friction piston that has sealing contours in both the tension and compression directions. This allows the piston to be used in both directions of movement while maintaining a seal.

[0028] The drive mechanism of the infusion pump can consist, in particular, of an electric drive motor and a transmission to transform the rotational movement of the drive motor into a translational movement (back-and-forth movement) of the piston, which is slidably mounted in the cylinder. Furthermore, the drive mechanism can be controlled / regulated, for example, by a control unit of the infusion pump.

[0029] In one embodiment, the infusion pump may include a valve device which, for example, is connected to and configured to the control unit to (possibly in a regulated / controlled manner) in the case of a pump delivery stroke, interrupt a connection between the piston-cylinder unit as an intermediate fluid reservoir and a supply port to a separate large fluid volume, and release a connection between the piston-cylinder unit and a patient port, and in the case of a pump suction stroke, release the connection between the piston-cylinder unit and the supply port to the separate large fluid volume, and block the connection between the piston-cylinder unit and the patient port.In the simplest case, the valve assembly can have passively actuated valve elements, for example, one or two check valves, housed in connecting lines, particularly separate, disposable connecting lines, to the patient connection and to the large fluid volume, which can be inserted into the infusion pump. This has the advantage that the valve assembly is particularly inexpensive to manufacture and can therefore be disposed of as a disposable item along with the entire fluid supply system.

[0030] Alternatively, the valve assembly can have actively actuated valve elements, for example, two hose clamps / pressors, which can act on flexibly deformable sections of the two connecting lines to seal them. These valve elements can be housed, in particular, in the infusion pump (or the pump module). In particular, the [possibly]A liquid supply system designed as a disposable item has a first, preferably elastically deformable hose section for fluid supply (from the large liquid reservoir to the intermediate reservoir) and a second, preferably elastically deformable hose section for fluid discharge (from the intermediate reservoir towards the patient), wherein the two hose sections are designed for insertion into the infusion pump and for connection to the piston-cylinder unit (intermediate liquid reservoir) for drawing fluid from the first hose section into the intermediate liquid reservoir and for dispensing fluid from the intermediate liquid reservoir to the patient.The hose clamps / pressors can preferably be designed as plungers / pistons or as scissor clamps or similar mechanical clamping devices, which are movably mounted in the infusion pump (and are thus part of the infusion pump) and can each be actuated by a drive connected to the control unit. The two hose clamps / pressors located at the inlet and outlet are preferably mechanically coupled to each other in such a way that at least one side securely clamps the hose. To prevent leaks when switching between the inlet and outlet, the hose clamps / pressors can be pre-tensioned so that they bridge the otherwise leaking positions. Alternatively, the valve timing can also be controlled by, for example, cam discs or by separate motor drives.

[0031] The control unit, which can be implemented, for example, as a motor-driven valve control, can block, preferably pinch off, the hose in the outlet (i.e., the second hose section) when the piston-cylinder unit is wound up. Furthermore, the hose in the inlet (i.e., the first hose section) can be blocked, preferably pinch off, when the piston-cylinder unit is pushed out. It is noteworthy that the piston-cylinder unit can be controlled like a piston pump. The control unit can, in particular, include a motor-driven rocker arm unit. This rocker arm can be designed and operate such that, in a first rocker position, it compresses the first hose section and releases the second hose section, and in a second rocker position, it compresses the second hose section and releases the first hose section.The control unit can also include a pressure piston pivotably mounted on the rocker arm unit. It can, in particular, comprise an inlet piston interacting with the first hose section and / or an outlet piston interacting with the second hose section. At least one pressure piston can be pre-tensioned by means of a pre-tensioning unit, in particular by means of a compression spring, into a position that releases the respective hose section, and in particular does not make contact. In this way, it can be ensured that the pressure pistons are not located in the area of ​​the corresponding hose section when the pump is not in operation. This enables particularly user-friendly changing, insertion, and removal of the pump module according to the invention.

[0032] A preferred embodiment of the pump module provides that the first hose section is equipped with a Luer-lock coupling at the end opposite the piston-cylinder unit. This coupling can, in particular, be designed as an inner Luer-lock cone. Alternatively or additionally, the second hose section can be equipped with a Luer-lock coupling at the end opposite the piston-cylinder unit. This coupling can, in particular, be designed as an outer Luer-lock cone. This allows for a particularly easy-to-operate method of connecting the pump module or the fluid supply system it contains to an extracorporeal line or piping system. The invention can therefore be readily and in a known manner used with existing and widely available medical devices.As an alternative to a Luer-lock connection, a drip chamber connected to the patient can be provided, or the second tubing section can be designed as a blind tube with a closed end and connected with a insertion spike. Additionally or alternatively, the use of a spike / penetrating pin is also an option to increase flexibility in application or the compactness of the pump.

[0033] The control unit and the drive can be arranged, in particular, on or in a housing part of the infusion pump.

[0034] The pump module can be arranged on the housing part in a user-replaceable manner. It is preferably installed in and / or removed from the pump without the use of special tools or devices. The pump module according to the invention can, in particular, be designed as a disposable item and intended for single use in the pump. This is especially advantageous and user-friendly with regard to sterile conditions. It can, for example, be implemented in the form of a disposable syringe, with the two hose sections fluidically connected to the delivery opening. This can be achieved such that the two hose sections form a continuous fluid line, which is provided with a branch in a region between the deformation points for connecting the piston-cylinder unit, in particular a disposable syringe.Alternatively, the piston-cylinder unit / disposable syringe can have two flow openings, an outlet and an inlet, each of which is connected to the corresponding hose section in terms of flow characteristics.

[0035] It is particularly advantageous if the drive for the piston-cylinder unit is a linear actuator / motor arranged along the piston's axis of movement. It is especially preferred if the drive is arranged and designed such that the forces acting on the piston are introduced centrally and axially. This is particularly advantageous because the forces acting on the piston can be minimized (compared to decentralized force application), thus requiring only minimal energy to actuate the piston-cylinder unit. Consequently, the drive, and therefore the pump, can be designed to be smaller, resulting in savings in weight, cost, and installation space. Furthermore, the central application of actuating forces to the piston allows for high precision.Using a small syringe as a piston-cylinder unit allows a linear drive to be positioned directly on the axis of the syringe piston, thus eliminating any lateral forces that could affect accuracy. Furthermore, the small cross-section of the syringe generates only minimal forces, enabling the use of a simple, cost-effective drive, such as a linear stepper motor. This allows the pump to be significantly smaller than conventional infusion pumps.

[0036] The infusion pump can also have a second drive, in particular a linear drive / motor, for the control unit. The two drives for the piston-cylinder unit and the control unit are preferably coupled to each other in such a way that the control function described above is achieved by squeezing the two tubing sections.

[0037] Since the pump drive(s) can be small, it is advantageous for the pump to include an energy storage unit, particularly a battery, and operate without a direct mains connection. The energy storage unit could, for example, be a standard lithium battery that can be charged via a USB interface. This can also be used to read data into and / or from a pump controller.

[0038] The pump module can have a sliding clamp that is adjustable to selectively allow or block fluid flow in the first and / or second tubing section. This ensures that no air bubbles form after the pump module is put into operation. The sliding clamp is preferably clippable onto a handle section of the pump module, making it easy to manufacture from a different material than the rest of the module. A sleeve or ring can be arranged at the end of the pump module or handle section opposite the sliding clamp. This sleeve secures the first and / or second tubing section, thus enabling a reliable connection of an infusion line to the pump module. It therefore serves as a retaining ring through which the infusion line can be threaded.

[0039] In summary, the invention enables an infusion system with the accuracy of a syringe pump and the delivery volume or volume reservoir of a peristaltic pump, while requiring significantly less energy, reducing size, and lowering manufacturing costs, while also offering high user-friendliness and safety. The invention offers, in particular, the following advantages: Easier operation for the user: The system ensures that the pump only operates when used correctly.

[0040] Further features and advantages of the invention will become apparent from the following exemplary and non-limiting description of the figures. These are merely schematic and serve only to illustrate the invention. They show: Fig. 1 a perspective view of the back of an infusion system with an infusion pump and a pump module inserted therein, Fig. 2 the infusion system of the Figure 1 in a sectional view with the pump housing partially exposed in a coupling position or infusion position, Fig. 3 a cross-sectional view of the infusion pump of the Figures 1 and 2 with the pump module inserted therein in a decoupling position, Fig. 4 a sectional view perpendicular to the cutting plane of the Figures 2 and 3 the infusion pump with the pump module inserted therein, Fig. 5 another sectional view perpendicular to the cutting plane of the Figures 2 and 3 the infusion pump with the pump module inserted therein during activation of an emergency release, Fig. 6 an embodiment of a pump module with an attached sliding clamp for disconnecting one of the fluid lines and Fig. 7 A perspective view of the front of an infusion system with an infusion pump and a pump module inserted therein.

[0041] The Figure 1 and 7show an embodiment of an infusion system according to the invention with an infusion pump 1 and with a pump module 2 inserted therein ( Figure 1 Back, Figure 7 Front side). The pump 1 has a housing 3, which preferably consists essentially of a lower housing part 4 with a housing cover 5 and a cover element 6, here in the form of a closure flap 6. The lower housing part 4 and the housing cover 5 are connectable / connected to each other, for example via snap-fit ​​connections or screw connections (not shown in the figures), and form the housing 3 when assembled. The lower housing part 4 has a housing base 7. Indicator elements 8, operating elements 9, and a display 10 of the pump 1 are arranged in or on the housing cover 5. An actuating element 16, here in the form of a sliding latch 16, is arranged in the lower housing part 4. A receptacle 30 for the pump module 2 is formed in the housing 3 (see in particular in Figure 2 ), which can be closed by means of the cover element 6. The receptacle 30 is open in the distal direction, closed in the proximal direction by means of a bottom wall 32 and enclosed by a side wall 33 (side walls 33) corresponding to the outer shape of the piston-cylinder unit. Overall, the receptacle 30 is compatible with the piston-cylinder unit 11 (shown in Figure 6 ) designed so that it can be positioned within it. In the bottom wall 32 of the receptacle 30, a central through-opening is formed, through which, as described later, a coupling rod 38 and a clamping sleeve 39 as a locking element 39 for coupling the piston 15 with the drive 26 are passed.

[0042] Pump module 2 is shown schematically in Figure 6 shown. A more detailed description of pump module 2 can be found in the Figures 3, 4 and 5It comprises a piston-cylinder unit 11, a first elastically deformable hose section 12, and a second elastically deformable hose section 13. The pump module 2 is designed as a single-use item (disposable item). The hose sections 12 and 13 can, in particular, be made of PVC hose.

[0043] The piston-cylinder unit 11 has a cylinder 14, which may be made of plastic and / or be manufactured as an injection-molded part, and a piston 15, which is reciprocally movable back and forth within it and may also be made of plastic and / or be manufactured as an injection-molded part. The cylinder 14 has a bottom wall 17, a circumferential wall 18, and a top wall 19. The piston 15 is sealed against the circumferential wall 18 by means of seals 20a, 20b arranged on both sides of it, so that the piston-cylinder unit 11 has a fluid chamber / metering chamber 21. The piston 15 has a dome structure 34 on its proximal side, i.e., on the side opposite the fluid chamber 21. This is formed by a central blind hole 35 in the piston 15, at the proximal edge of which dome hooks 36 with detent contours are arranged. A fluid channel 31 is formed in the bottom wall 17.At its distal end, the piston-cylinder unit 11 has a cylinder head 24, on which a handle element 25 is arranged distally for user handling of the pump module 2, particularly when inserting it into or removing it from the receptacle 30 of the infusion pump 1. An annular bead 52 located in the side wall 18 provides an axial stop for the piston 15, thus defining the maximum stroke of the piston-cylinder unit 11 and preventing the piston 15 from falling out of the cylinder 14 by means of a positive locking mechanism.

[0044] The piston 15 is preferably arranged / designed / fixed as a low-friction piston and has a seal 20a, 20b designed as a movable sealing lip at its distal and proximal ends, respectively. In the illustrated embodiment, the distance along the longitudinal direction L between the distal seal 20a and the proximal seal 20b of the piston 15 exceeds the piston stroke of the piston-cylinder unit 11. This ensures that the cylinder wall of the fluid chamber / metering chamber 21 is in contact exclusively with the single, distal seal 20a, thereby guaranteeing its sterility. Preferably, the excess between the distance along the longitudinal direction L between the distal seal 20a and the proximal seal 20b of the piston 15 and the piston stroke is at least 2 mm.

[0045] The cylinder head 24 has an inlet bore 22 and an outlet bore 23 (see Figure 6), which are fluidically connected on the one hand to the fluid channel 31 and on the other hand to the first hose section 12 and the second hose section 13. In this way, the fluid chamber 21 is fluidically connected to the first hose section 12 via the fluid channel 31 and the inlet bore 22, and to the second hose section 13 via the fluid channel 31 and the outlet bore 23. The hose sections 12, 13 can, in particular, be integrally formed with the cylinder 14 or the cylinder head 24. They can, in particular, be designed like conventional infusion tubing. In this embodiment, the first hose section 12 is made of Figure 3The first tube section 13 is equipped with an inlet Luer-lock connector (not shown) at the end furthest from the piston-cylinder unit 11. The second tube section 13 is equipped with an outlet Luer-lock connector (not shown) at the end furthest from the piston-cylinder unit 11. This allows the pump module 2 to be easily connected to standard infusion sets.

[0046] The Figures 2 to 5 The figures show that the pump 1 has a (pump-integrated) drive 26 for the piston-cylinder unit 11, here in the form of a linear motor 26. The motor 26 is arranged congruently with the longitudinal axis L of the piston-cylinder unit 11, so that forces for reciprocally driving the piston 15 can be transmitted centrally and without twisting / lateral forces. The drive 26 is fixed in position on the lower housing part 4 by means of a mounting in an intermediate wall 27.

[0047] The drive 26 can be coupled to the piston 15 via a drive rod 37 and a coupling rod 38. Both the drive rod 37 and the coupling rod 38 are integral parts of the infusion pump 1 and are permanently coupled to each other and to the drive motor 26, meaning they are not intended to be disconnected by the user. The drive rod 37 is driven by the drive motor 26 and can therefore move back and forth along its longitudinal axis L. At its distal end, the coupling rod 38 has a counter-coupling structure 40, which is designed to match the coupling structure 34 of the piston 15. The counter-coupling structure 40 consists of a reduced-diameter area with a circumferential recess 41 or groove 41, which is suitable and designed for coupling engagement with the coupling hooks 36 of the piston 15.

[0048] A locking element 39, here in the form of a clamping sleeve 39, is arranged on the coupling rod 38 and can be positioned relative to the coupling rod 38 in the direction of the longitudinal axis L between a distal clamping position and a proximal release position. In the clamping position (see Figure 4 The clamping sleeve 39, with its distal end section, overlaps the dome hooks 36 engaging in the recess 41, so that these cannot detach from the recess by deformation radially outwards and the connection between the dome structure 34 and the counter-dome structure 40 is secured. In the release position ( Figure 5The distal end section of the clamping sleeve 39 releases the dome hooks 36, allowing them to deform radially outwards and release from the recess 41 when a user grasps the pump module 2 by the handle element 25 and pulls it distally out of the receptacle 30. The clamping sleeve 39 is pre-tensioned in the distal direction, i.e., into its clamping position, by means of a compression spring 42.

[0049] The infusion pump 2 also has a control cam 43. This is located in a frame 46 of the lower housing part 4 in a direction transverse to the longitudinal direction L between a decoupling position / locking position ( Figure 2 ) and a release position / pump position ( Figure 3The control cam 43 is mounted in a positionable manner. It is coupled to a toggle lever mechanism 47, which essentially consists of a first lever arm 48 and a second lever arm 50 connected to it via a free joint 49. The first lever arm 48 is essentially L-shaped and pivotably mounted on the lower housing part 4 by means of a pivot joint 51 fixed to the lower housing part 4. Its end opposite the free joint 49 is coupled to an actuating rod 53 that interacts with the cover element 6. The second lever arm 50 is rotatably coupled to the control cam 43 at its end opposite the free joint 49.

[0050] The control cam 43 has a lower wall 54 on the lower housing side, an upper wall 55 opposite this on the upper housing side, and two side walls 56 connecting the upper wall 55 and the lower wall 54. The second lever arm 50 is coupled to one side wall 56, while the other side wall 56 is coupled to a compression spring 57 supported on the frame 46, which moves the control cam 43 in the direction of the second lever arm 50 (in the Figures 1, 2 and 3 to the right, into the Figures 4 and 5 (from the plane of the drawing) pre-tensioned. A control groove 58 is formed in the lower wall 54 (and identically in the upper wall 55). This has a release section 59 extending in the longitudinal direction L (see in Figure 2 ) and a barrier section 60 that initially slopes and then runs transversely to the longitudinal direction L (see in Figure 3 ) on.

[0051] The clamping sleeve 39 has two diametrically opposed control cams 61 which engage in the control grooves 58 of the upper wall 55 and the lower wall 54.

[0052] From the Figures 2 to 5 It follows that the cover element 6 in the form of the closure flap 6 is located between an open position ( Figure 3 ) and a closed position ( Figures 2 , 4 and 5 ) is pivotably arranged on the lower part of the housing 4 by means of a hinge joint 62. It is provided with a positioning pin 63, which interacts with the second hose section 13 and ensures that, when the closing flap 6 is closed, it is positioned as intended on an air sensor 44.

[0053] To use pump 1, the user first opens the locking flap 6 of pump 1, for example by inserting a special key laterally into a designated bore and unlocking the flap 6. When the front flap 6 is open, the control cam 43 is in the decoupling or locking position and the coupling rod 38 is extended. This pushes the actuating rod 53 outwards (distally) by means of the two lever arms 48, 50. After the infusion line, including the two tubing sections 12, 13, has been filled without air bubbles, the second tubing section 13 is sealed fluid-tight using a sliding clamp 45. The user then slides the pump module 2 into the designated receptacle 30 of pump 1, which is located in the Figure 2 shown state with control cam 43 in the decoupling or locking position (in Figure 2to the right) and the clamping sleeve 39 in the release position (shifted in the proximal direction) is, until the dome structure 34 engages with the counter-dome structure 40, i.e. the dome hooks 36, preferably audibly and / or tangibly, in the recess 41 and the piston-cylinder unit 11 is connected to the drive 26.

[0054] The locking flap 6 is then closed. In doing so, the locking flap 6 interacts with the actuating rod 53 and moves it proximally. As a result, the first lever arm 48 performs a pivoting movement (in the Figures 2 and 3 counterclockwise) around the fixed pivot joint 51, whereby the control cam 43 is moved in the frame 46 by means of the second lever arm 50 against the preload of the compression spring 57 (from the in Figure 2 shown locking position to the left into the Figure 3(shown release or pump position). The clamping sleeve 39 is moved distally into its clamping position by means of the control cams 61 engaging in the control groove 58, in which the dome structure 34 and the counter-dome structure 40 are secured to each other. The compression spring 42 located on the clamping sleeve 39 ensures a secure connection during operation.

[0055] A locking mechanism located in the upper housing part 5 ensures that the flap 6 is securely locked in the closed position. Simultaneously, the second tubing section 13 is positioned as intended for the air sensor, for example, by being pressed against it. This ensures the detection and corresponding communication of any air bubbles that may be present or introduced during an infusion.

[0056] The user now enters the desired flow rate via the display elements 8 and the control elements 9. These are displayed on the screen 10, which, according to one embodiment, can be a touchscreen, allowing input via the screen 10 (operation via an app on a mobile phone or tablet is also possible and within the scope of the invention). Immediately after activation, the pump 1 starts. As soon as the user has started the infusion, the drive rod 37 of the linear motor 46, with the coupled coupling rod 38 including clamping sleeve 39 and piston 15, moves back and forth in the release section 59 of the control groove 58 of the control cam 43, thereby pumping infusion solution towards the patient.

[0057] After the infusion is complete, pump 1 is switched off. The drive rod 37 of the linear motor 46 moves the coupling rod 38 with the piston 15 back to its starting position. As soon as the user opens the cover element 6, the compression spring 57 pushes the control cam 43 towards the locking position (into the Figures 2 and 3 (to the right). The actuating rod 53 is moved outwards (distally) again via the toggle lever mechanism 47. As the control cam 43 moves back into the locked position, the clamping sleeve 39, due to the engagement of the control cam 61 in the control groove 58, is positioned proximally relative to the coupling structure 34 and counter-coupling structure 40, releasing them. This allows the piston 15 to be released from the coupling rod 38 by the coupling hooks 36 springing back. The user can now remove the pump module 2 from the receptacle 30 of the infusion pump 1.

[0058] In case of an emergency or if the infusion pump 1 has a technical defect, the piston 15 can be unlocked via an emergency release using the actuating element 16. (See...) Figures 4 and 5 The actuating element 16 is manually pushed proximally (see also arrow on the actuating element 16 in Figure 1 A drive cam 64, which engages with the control cam 61 of the clamping sleeve 39, pushes the clamping sleeve 39 backwards (proximally), so that the coupling structure 34 and the counter-coupling structure 40 are released and the piston 15 can be separated from the coupling rod 38. To prevent the emergency release from being in the release or pumping position (shown in Figure 3 ), but only in the decoupling or locking position (shown in Figure 2 ) works, is located (see especially in Figure 5On the control cam 43, a bridge 65 or cam 65 is located, which, when the control cam 43 is in the release or pump position, interacts with the drive cam 64 and prevents a user from accidentally triggering the emergency release during infusion. Alternatively, the control cam 43 can be controlled by another linear motor. Reference symbol list

[0059] 1 Infusion pump 2 Pump module 3 Housing 4 Housing base 5 Housing cover 6 Cover element, locking flap 7 Housing base 8 Display elements 9 Operating elements 10 Display 11 Piston-cylinder unit 12 First tubing section 13 Second tubing section 14 Cylinder 15 Piston 16 Actuating element, sliding latch 17 Base wall 18 Circumferential wall 19 Cover wall 20 Seal 21 Fluid chamber / Dosing chamber 22 Inlet bore 23 Outlet bore 24 Cylinder head 25 Handle element 26 Actuator, linear motor 27 Partition wall 28 Control unit 29 Partition wall 30 Mounting 31 Fluid channel 32 Base wall 33 Side wall 34 Dome structure 35 Blind hole 36 Dome hook 37 Drive rod 38 Coupling rod 39 Locking element, clamping sleeve 40 Counter-coupling structure 41 Recess42 Groove 43 Compression spring 44 Control cam 45 Air sensor 46 Sliding clamp 47 Frame 48 Toggle mechanism 48 First lever arm 49 Free joint 50 Second lever arm 51 Swivel joint 52 Ring bead 53 Actuating rod 54 Lower wall 55 Upper wall 56 Side walls 57 Compression spring 58 Control groove 59 Release section 60 Locking section 61 Control cam 62 Hinge joint 63 Positioning pin 64 Drive cam 65 Web, cam Longitudinal direction, axial direction

Claims

1. An infusion system comprising an infusion pump (1) and a pump module (2) being separate therefrom and provided as a disposable product and thus being replaceable and which can be or is arranged in a mount (30) of the infusion pump (1) and includes a plunger-barrel unit (11) operatively connectable to a drive mechanism (26) of the infusion pump (1) comprising a plunger (15) translationally movable within a barrel (14), the plunger being adapted to be coupled to the drive mechanism (26) by means of a coupling structure (34) operatively connected to the plunger and by means of a counter-coupling structure (40) configured for connecting engagement in the coupling structure (34) and being operatively connected to the drive mechanism (26), characterized in that the infusion pump (1) has a control link (43), wherein the control link (43) is operatively connected or operatively connectable to the pump module (2) so that, when the pump module (2) is arranged in the mount (30) as intended, the control link is positioned by force in a release position in which pumping action of the plunger (15) gets released by the control link (43), and that, when the pump module (2) is not arranged in the mount (30) as intended, the control link is positioned by force in a blocking position in which pumping action of the plunger (15) gets locked by the control link (43).

2. The infusion system according to claim 1, characterized in that the infusion system further includes a securing member (39) which is designed for locking the coupling structure (34) and the counter-coupling structure (40) in the coupled state to each other in a securing position.

3. The infusion system according to claim 1 or 2, characterized in that the infusion pump (1) includes a cover member (6), especially in the form of a cover flap (6), which can be positioned in a closing position closing the mount (30) for the pump module (2), wherein the cover member (6), the mount (30) and the pump module (2) are adapted to each other and designed so that, when the pump module (2) is not arranged in the mount (30) as intended, the cover member (6) cannot be positioned in the closing position closing the mount (30).

4. The infusion system according to claim 3, characterized in that the cover member (6) is operatively connected to the control link (43) in such a way that the control link (43) is positioned by force into the release position when the cover member (6) is provided in the closing position and is positioned by force into the blocking position when the cover member (6) is not provided in the closing position.

5. The infusion system according to one of the claims 2 to 4, characterized in that the securing member (39) is operatively connected to the control link (43) in such a way that the securing member (39) fixes the coupling structure (34) and the counter-coupling structure (40) when the control link (43) is provided in the release position, and the securing member (39) releases the coupling structure (34) and the counter-coupling structure (40) when the control link (43) is provided in the blocking position.

6. The infusion system according to one of the claims 3 to 5, characterized in that the infusion system, especially the infusion pump (1), includes a toggle lever mechanism (47) which, on the one hand, is operatively connected to the pump module (2), especially by coupling to the cover member (6), and, on the other hand, is operatively connected to the control link (43), especially articulated to the control link (43).

7. The infusion system according to one of the preceding claims, characterized in that the control link (43) is prestressed to the blocking position, especially by means of a spring element (57) such as a flexural spring, compression spring or tension spring.

8. The infusion system according to one of the claims 2 to 7, characterized in that the securing member (39) is a sleeve-shaped hollow body, the longitudinal axis of which is oriented in parallel to, especially congruent to the plunger axis, and in that the securing member (39) can be positioned relative to the coupling structure (34) and the counter-coupling structure (40) in the direction of the plunger axis between the securing position and a release position.

9. The infusion system according to one of the claims 2 to 8, characterized in that the securing member (39) is biased to the securing position, especially by means of a spring element (42) such as a flexural spring, compression spring or tension spring.

10. The infusion system according to one of the claims 2 to 9, characterized in that the infusion system includes an emergency release comprising an actuating element (16) coupled to the securing member (39) so as to manually actuate the securing member (39) and to move the same from the securing position to a release position.

11. The infusion system according to claim 10, characterized in that the actuating element (16) is coupled to the control link (43) so that, when the control link (43) is provided in the release position, it will block and cannot be actuated for moving the securing member (39) from the securing position to a release position.