Trochoidal drug pump device

Abstract

A trochoidal drug pump device and a supply set containing a trochoidal drug pump device having specific geometric shapes and material selectivity. The trochoidal drug pump device and the supply set containing a trochoidal drug pump device provide trochoidal drug pump devices and a supply set containing a trochoidal drug pump device having improved delivery characteristics, accuracy, reliability, and lifespan.

Description

[Technical Field]

[0001] The present invention relates to a trochoidal medicament pump device having a specific geometric shape and material selectivity, and further to a giving set including the trochoidal medicament pump device. The trochoidal medicament pump device and the giving set including the trochoidal medicament pump device according to the present invention provide a trochoidal medicament pump device and a giving set including the trochoidal medicament pump device with improved delivery characteristics, accuracy, reliability, and lifespan. [Background technology]

[0002] Trochoidal pump devices are known for pumping applications, for example, from U.S. Patent No. 4,137,024 describing rotary piston mechanisms such as compressors and expansion engines, and from Japanese Patent Publication No. 62-17322 describing rotary piston type compressors. Trochoidal pump devices are also known for pumping applications in refrigerators, for example, as described in U.S. Patent No. 6,520,754 describing compressors for household refrigerators. U.S. Patent No. 6,168,405 B1 describes a vacuum cleaner with a Wankel type pump for pumping air, the chamber having an epitrochoidal plan view satisfying a specific equation.

[0003] Trochoid pump devices for medical use are also known, for example, from International Publication No. 2019 / 057570, which describes rotary pumps for use in drug delivery devices.

[0004] Furthermore, International Publication 2021 / 109759 A1 describes a triangular rotor pump, but it has no relation to drug delivery. Furthermore, International Publication 2019 / 057570 A2 describes a rotary pump and medical device for administering one or more liquid drugs to a patient, but it has no modularity or interchangeability of the pump and its drive unit. U.S. Patent No. 9,511,186 B1 describes an elliptical rotor drug infusion system with a pump, but it does not have a trochoid shape. U.S. Patent No. 2021 / 353854 A1 describes an infusion pump with a pump engine, but it does not have a receptacle for a trochoid pump. U.S. Patent Application Publication 2018 / 010612 A1 describes a flexible impeller pump, but it does not have a trochoid pump. U.S. Patent Application Publication 2019 / 143039 A1 describes an infusion device having different helical or curved needle shapes. International Publication 01 / 39816 A2 describes an infusion pump, but it does not have a trochoid pump.

[0005] According to known prior art, the objective can be considered to be to provide a trochoidal drug delivery device having improved delivery characteristics, higher accuracy, higher reliability, and a longer lifespan. [Overview of the Initiative]

[0006] The present invention provides a trochoidal drug pump device and a supply set including the trochoidal drug delivery device according to independent claims, while further embodiments are incorporated into dependent claims.

[0007] According to one embodiment, the pump includes a pump body having an inlet port for the drug to be administered to enter and an outlet port for administering the drug, and a pump rotor having a triangular convex shape and having an eccentric trajectory after rotation within the pump body, i.e., after rotation around an axis, wherein the pump rotor has three equidistant vertices, each pair of vertices being connected by a convex curve, the pump body has a pump chamber, the pump chamber has a first lobe forming a first inner wall portion of the pump volume of the pump chamber, the first inlet being in fluid communication with the inlet port, the first outlet being in fluid communication with the outlet port, and the pump rotor having the first inner wall portion so that after rotation the rotor forms a first suction volume in fluid communication with the first inlet and a first discharge volume in fluid communication with the first outlet. A trochoidal drug pump device is provided, which rotates eccentrically, i.e., around an axis, and the pump rotor has a rigid rotor core and an elastic or elastomeric overmolding covering a sealing line at least along the apex and a sealing line along a convex curve, the overmolding being made of an elastic or elastomeric material of a first material class, the first inner wall portion being made of a material of a second material class, and the external dimensions of the pump body, including the overmolding with the apex and bottom, are equal to or greater than the corresponding internal dimensions of the pump chamber, and the apex of the eccentrically rotating pump rotor follows a trochoidal line corresponding to a trochoidal shape that is equal to or greater than the corresponding internal dimensions of the pump chamber.

[0008] Therefore, trochoidal drug pump devices can provide reliable drug delivery. In the context of rotary pumps, a trochoid is defined as a planar curve produced by tracing the trajectory of a fixed point relative to one circle, which rotates along another fixed circle. In the literature, this may also be called an epitrochoid or hypotrochoid, depending on whether the rotating circles are in external or internal contact with the respective fixed circles. Thus, trochoidal shapes are generated using this geometric method. Larger dimensions of the rotor, combined with an overmolded stretchable or elastic material, provide reliable sealing over the pump chamber. The intention is to make the pump chamber airtight so that the pressure can be low enough to pull the fluid through the tube, for example, to move a syringe / cartridge plunger, and to reduce any variation in dosage over time despite external influences. A rigid rotor core maintains the general geometric shape of the rotor and allows for secure coupling of the rotor to the drive component that drives the rotor on the pump body. Rigidity means that the material is inelastic or at least less elastic than an elastic overmolding. An elastic overmolding provides reliable sealing regardless of the rotor's rotational position on the pump body. After eccentric rotation of the rotor, the rotor forms a suction chamber that communicates with the inlet, allowing fluid to enter the suction chamber. The eccentric rotation expands the suction volume after further rotations so that fluid is drawn into the suction volume. The suction volume rotates with the rotor until one of its vertices passes the inlet, thus closing the suction volume. As soon as the fluid-filled volume communicates with the outlet, the volume becomes the discharge volume, and after further rotations, the volume decreases, thus discharging the fluid. Simultaneously, the subsequent portion of the rotor's triangular geometric shape is already acting as the suction volume, and the above procedure is repeated. Thus, the suction volume is a volume as long as it is connected to the inlet port. As soon as the volume is connected to the outlet, the volume becomes the discharge volume.The geometric shape of the trochoid lobe, in combination with a convex curve, results in a very small volume after discharge and before the next vertex passes the outlet, so that almost all, or ideally all, of the fluid is discharged. In some phases of rotor rotation, three parts of the rotor are in permanent contact with the inner wall of the first lobe, so the fluid drawn into the suction volume is transported until the volume becomes the discharge volume and the fluid is discharged, but the subsequent geometric shape has just formed the subsequent suction volume, and in this iterative procedure, the rotor, together with its inner wall, always forms both a suction volume and a discharge volume simultaneously. This principle is analogous to the so-called Wankel piston.

[0009] It should be noted that the terms apex and convex curved line should be understood in terms of a plan view, i.e., without a third dimension. In the third dimension, an apex is a line, and a convex curved line is a convex surface. This surface is confined by two adjacent apex lines and two curved convex lines connecting the endpoints of both apex lines.

[0010] According to one embodiment, the overmolding is made of a biocompatible elastic material of a first material class, and the first inner wall portion is made of a biocompatible material of a second material class.

[0011] Therefore, the pump and all its components that come into contact with the chemical liquid or fluid are resistant to deterioration or decomposition, so that no material from the rotor, especially the overmolding, or the pump body, especially the inner walls, enters the chemical liquid.

[0012] According to one embodiment, the rigid rotor core has an undercut geometric shape, and the undercut geometric shape has undercuts perpendicular to the rotation axis of the rotor along each convex curve.

[0013] Therefore, a core with an undercut geometric shape provides a maximized surface for chemical bonding, such as adhesive bonding, as well as a maximized undercut with a narrow opening, so that the overmolded stretchable material cannot slip back through the slots, even under high pressure and high tensile force applied to the overmolded material and / or under pressure in an active pumping chamber, which would allow the overmolded material to slip back if bonding is insufficient. Thus, the undercut serves as an additional safety measure in addition to surface bonding of the overmolded to the core. The resulting forces, regardless of their origin, may be received partly by surface bonding and partly by undercuts. If either surface bonding or undercuts fails, the other may take over.

[0014] According to one embodiment, the rigid rotor core has a plurality of recesses along each convex curve that are adapted to provide access for overmolding into an undercut geometric shape.

[0015] Therefore, the adhesion of the overmolding to the rotor core can be improved, and detachment of the overmolding from the core can be avoided. This can maintain the geometric shape, enable reliable feeding and delivery of the drug liquid or fluid, contribute to more reliable sealing between chambers, and avoid the possibility of air entering the active pumping chamber. Furthermore, better manufacturing of the overmolding is achieved, and improved bonding of the overmolding above and below the undercut geometric shape in the radial direction is achieved. According to one embodiment, smaller and wider recesses may be provided to provide secure mechanical fixation of an expandable material, e.g., an LSR. The dimensions of the slots, i.e., the gap width, depend on the expandability and shear force of the expandable overmolding material. Cylindrical holes parallel to the axis of rotation may be provided to fix the top and bottom portions of the overmolding below the undercut geometric shape. The dimensions of these holes may depend on the flow index and shear force of the unspecified overmolding material.

[0016] According to one embodiment, the first material class is comprised of liquid silicone rubber (LSR), ethylene propylene diene monomer rubber (EPDM), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), liquid crystal polymer (LCP), butyl rubber, and nitrile rubber.

[0017] Thus, a flexible material having sufficient sealing characteristics, low friction on the pump body material, and durability may be provided. Liquid silicone rubber LSR has been found to be particularly suitable for 2k molding, especially in medical devices, which have requirements for multiple sterilization processes that do not compromise physical properties. Ethylene propylene diene monomer rubber EPDM has been found to be particularly suitable for polar liquids. TPE has been found to be particularly suitable for short-term use, having a larger compression set, lower friction, and, for example, bonding compatibility with glass-filled materials. TPU has been found to be particularly suitable for the normal use of tubes, bags, and membranes. Butyl rubber has been found to be particularly suitable for cartridge plungers, and nitrile rubber has been found to be suitable for sealing elements.

[0018] According to one embodiment, the first material class is self-lubricating liquid silicone rubber LSR.

[0019] Thus, friction can be permanently reduced after rotation. According to one embodiment, the self-lubricant LSR is biocompatible.

[0020] According to one embodiment, the first material is liquid silicone rubber treated with a medical-grade biocompatible lubricant, particularly medical-grade biocompatible silicone oil.

[0021] Thus, friction can be permanently reduced after rotation.

[0022] According to one embodiment, the overmold is made of liquid silicone rubber LSR having a hardness of 10 to 100 Shore (ShA), particularly 20 to 80 Shore (ShA), particularly 40 to 60 Shore (ShA), particularly 50 + / - 5 Shore (ShA).

[0023] Therefore, it may be possible to achieve a good balance between acceptable friction and reliable sealing that is useful for reliably operating the pump with reasonable power effort. To use LSR having a hardness between 50 and 100 Shore (ShA), especially between 60 and 70 Shore (ShA), for overmolding, this LSR configuration has been found to be suitable for meeting the requirements for low torque, minimum energy consumption, best fit in wear, friction, noise, sterilization, biocompatibility, life use, and use in a large temperature and humidity range.

[0024] According to one embodiment, the rotor has an internal sealing lip provided on at least one side of the rotor orthogonal to the rotation axis of the rotor, and the internal sealing lip is provided on each side in the radial direction between the gear section and the convex curve of the rotor.

[0025] Therefore, in addition to the main sealing line along the convex curve, a further backup seal may be provided that is recessed (set back) compared to the main seal so as to have lower friction than the main seal. The internal seal lip may function as a safety seal to prevent air intrusion through the eccentric position opening. This lip may be recessed compared to the main seal to which less pressure is applied to the housing and arranged cylindrically around the eccentric bearing.

[0026] According to one embodiment, the second material class is the group consisting of polyethylene terephthalate PET, polycarbonate PC, Tritan, cycloolefin copolymer COC, PBT, PPS, and PEI.

[0027] Therefore, a rigid material with sufficient sealing properties on the rotor material, low friction and durability on the pump rotor material may be provided. Tritan is a copolymer made from three monomers, namely dimethyl terephthalate (DMT), cyclohexanedimethanol (CHDM), and 2,2,4,4-tetramethyl-1,3-cyclobutanediol (CBDO). Polyethylene terephthalate (PET) has been shown to be particularly suitable for long-term use and durability. Polycarbonate (PC) has been shown to be particularly suitable for short storage times. Tritan has been shown to be particularly suitable for all types of drugs and liquids with a long shelf life without quality loss. Cycloolefin copolymers (COC) have been shown to be particularly suitable for most liquids and drugs. PBT has been shown to be comparable to PET in terms of being particularly suitable for long-term use and durability. PPS has been shown to be particularly suitable for a high-precision extreme temperature range, and PEI has been shown to be particularly suitable for its high-temperature resistance. Generally, these materials are also suitable for essential requirements such as sterilization, biocompatibility, long-term applications, and use in wide temperature and humidity ranges.

[0028] According to one embodiment, the biocompatible material of the second material class is thoritan mixed with a medical-grade absorbent.

[0029] Therefore, it is possible to absorb the light from the welding laser in order to convert the light radiation into heat and melt the material for welding. The absorber may be positioned in specific areas where welding is intended to take place, while no absorber is provided in areas where welding should be avoided.

[0030] According to one embodiment, the absorbent is adapted to absorb light radiation from a welding laser, particularly wavelengths between 960 nm and 1000 nm, especially wavelengths of 980 + / - 10 nm.

[0031] Therefore, light absorption can be performed at the wavelength of an infrared laser.

[0032] According to one embodiment, the rotor core is made of a material from a second class of materials that is filled with reinforcing fibers.

[0033] Therefore, the core may have higher stability.

[0034] According to one embodiment, the rotor core is made of a material containing PTB and 30+ / -10% by weight of glass fibers.

[0035] Therefore, a strong core can be provided. It should be noted that carbon fiber may be used instead of glass fiber.

[0036] According to one embodiment, the outer dimensions of the pump rotor having an overmolded section are greater than the corresponding inner dimensions of the contact portion of the pump chamber by a factor, where the factor is between 1.01 and 1.1, particularly between 1.01 and 1.05, and particularly between 1.02 and 1.03.

[0037] Therefore, a reliable seal can be established with reasonable friction, which enables operation under reasonable power demands. It was found that coefficients between 1.01 and 1.1, especially between 1.01 and 1.05, and especially between 1.02 and 1.03, are suitable for liquid viscosities up to 50 cP (centipoise).

[0038] According to one embodiment, the coefficient in the radial direction is between 1.01 and 1.1, particularly between 1.01 and 1.05, and particularly between 1.02 and 1.03.

[0039] Therefore, reliable sealing in the radial direction can be achieved. The radial direction is perpendicular to the axis of rotation, which corresponds to the direction perpendicular to the vertex line that contacts the wall portion of the pump chamber. It has been found that coefficients between 1.01 and 1.1, especially between 1.01 and 1.05, and especially between 1.02 and 1.03, are suitable for drugs with viscosities between 1 cP and 50 cP and chamber pressures up to 10 bar (1 MPa).

[0040] According to one embodiment, the coefficient in the axial direction is between 1.01 and 1.1, particularly between 1.01 and 1.05, and especially between 1.02 and 1.03.

[0041] Therefore, reliable sealing in the axial direction can be achieved. The axial direction is the direction parallel to the axis of rotation, which corresponds to the direction parallel to the vertex line that abuts against the wall portion of the pump chamber, and which corresponds to the direction perpendicular to the bend line that abuts against the bottom of the pump chamber and the inner wall of the cover.

[0042] According to one embodiment, the outer dimensions of the pump rotor having an overmolded portion in the radial direction are at least 0.01 mm larger than the corresponding inner dimensions of the contact portion of the pump chamber.

[0043] Therefore, a reliable seal can be achieved radially under applied pressure.

[0044] According to one embodiment, the external dimensions of the pump rotor having an axial overmolding are at least 0.07 mm larger than the corresponding internal dimensions of the contact portion of the pump chamber.

[0045] Therefore, a reliable seal can be achieved in the axial direction under applied pressure.

[0046] According to one embodiment, the overmolding at each convex curve has a closed gas reservoir, and the gas reservoir is under pressures higher than atmospheric pressure, particularly 1.2 x 10⁻¹⁰ 5 Pa~2.0x10 5 The pressure is between Pa, especially 1.3 x 10⁻⁶. 5 Pa+ / -0.2x10 5 It is filled with gas at a pressure of Pa.

[0047] Therefore, it is possible to compensate for the volume change of the pump chamber after rotation. Since the liquid is usually not compressible, even a slight change in volume after rotation may have an undesirable impact such as leakage, air bubbles, and loss of the liquid to be delivered. The gas in the gas volume is compressible and may change its volume after positive and negative pressures, so this volume change may compensate for the volume change of the pump volume. The gas volume after expansion may move the overmold covering the gas reservoir towards the pump volume, and vice versa. Since the overmold is elastic, the volume in the gas reservoir may change.

[0048] According to one embodiment, the gas reservoir has a volume between 1 mm 3 and 20 mm 3 , particularly between 1 mm 3 and 10 mm 3 , particularly between 2 mm 3 ±0.5 mm 3 .

[0049] Therefore, a good balance can be achieved between volume compensation on the one hand and morphological stability of the pump volume on the other hand, which is required for pumping the pharmaceutical liquid.

[0050] According to one embodiment, the first inlet and the first outlet end at the first inner wall portion of the pump volume of the pump chamber such that at least one of the vertices is located between the first inlet and the first outlet in the rotational direction after the eccentric rotation of the pump rotor, and the rotational difference α between the rotational position of the pump rotor when the vertex has just passed through the first inlet and the rotational position of the pump rotor when another vertex has just started passing through the first outlet is 14° or less, particularly 10° or less, particularly between 6° and 10°.

[0051] Therefore, even in the worst case of tolerance matching, it can be ensured that if the inlet is already closed, the outlet will only open.

[0052] According to one embodiment, the pump chamber has a trochoidal shape in which a first lobe and a second lobe form a second inner wall portion of the pump volume of the pump chamber, and the pump rotor rotates eccentrically with a vertex that moves along a trochoidal line corresponding to the trochoidal shape of the pump chamber, thereby forming a second suction volume and a second discharge volume after rotation.

[0053] Therefore, to avoid impurities, it is possible to provide a symmetrical build-up that avoids imbalances when operating the pump device and allows for proper sealing of the environment.

[0054] According to one embodiment, the second inner wall portion has a circumferential notch formed in the second inner wall portion that forms a pressure compensation bypass between the second discharge volume and the second suction volume after the rotation of the pump rotor, with notch in the cross-sectional direction being at least.

[0055] According to one embodiment, the pump body has a cover that covers and seals the pump chamber on at least one axial side, and the cover has a recess that is axially recessed in the region covering the second lobe compared to the region covering the first lobe, so that the outer dimensions of the pump rotor having the overmolded are larger by a coefficient than the corresponding inner dimensions of the contact portion of the pump chamber, and the coefficient in the region of the second lobe is smaller than the coefficient in the region of the first lobe.

[0056] Therefore, friction on the side of the second lobe can be reduced. Since the second side may not be used for pumping, the sealing characteristics on the side of the second lobe may be lower, and as a result, oversize can be reduced by providing a recess.

[0057] According to one embodiment, the recess that is axially recessed in the region covering the second lobe is between 0.01 mm and 0.2 mm, particularly between 0.05 mm and 0.1 mm, and particularly between 0.1 mm + / - 0.03 mm. Alternatively, the recess may have dimensions corresponding to a 50% pressure overlap.

[0058] Therefore, a definite reduction in friction can be achieved.

[0059] According to one embodiment, the interface between the pump chamber and the cover provides a unique mounting position for the cover on the pump chamber.

[0060] Therefore, manufacturing and assembly can be made more reliable because unintended mixing of orientations during assembly can be avoided.

[0061] According to one embodiment, the interface is formed by a keyhole projection on the cover and the other pump body housing that engages with a keyhole on one of the pump body housings and the other pump body housing, so that the cover can be positioned on the pump chamber in only one position.

[0062] Therefore, it is possible to achieve the ability to position the cover over the pump chamber in only one correct position or orientation.

[0063] According to one embodiment, the cover includes an axially projecting rim that protrudes from the side of the cover facing the pump chamber.

[0064] Therefore, a secure connection and bond can be achieved between the pump body housing and the pump body cover.

[0065] According to one embodiment, the second inner wall portion has a notch in the circumferential direction, at least in the cross-sectional direction, which forms a pressure compensation bypass between the second discharge volume and the second suction volume after the rotation of the pump rotor.

[0066] Therefore, pressure build-up and underpressure may be compensated after using only one lobe for pumping. The purpose of the bypass in the second chamber region is to reduce the driving torque and reduce sealing defects driven by the pneumatic pressure generated in the second chamber. Since the post-rotation pressure in the second suction chamber and second discharge chamber is compensated, there is no need to provide a second inlet and second outlet for pressure compensation. Thus, the pump chamber may be sealed across the environment, which reduces impurities from the outside.

[0067] According to one embodiment, the pump chamber within the pump volume of the second lobe has a second inlet that is in fluid communication with an inlet port and a second outlet that is in fluid communication with an outlet port, and the pump rotor rotates eccentrically such that at least three distinct parts of the rotor are in permanent sealing contact with the first inner wall portion of the first lobe and the second inner wall portion of the second lobe, thereby forming, after rotation, a second suction volume that is in fluid communication with the second inlet and a second discharge volume that is in fluid communication with the second outlet, in particular the second inlet being in fluid communication with the inlet port and the second outlet being in fluid communication with the outlet port.

[0068] Therefore, a symmetrical pump geometric shape can be provided that offers two parallel operating pump sequences, one on the first lobe and the other on the second lobe. Since the rotor is triangular and the pump chamber provides two lobes, the phase shift between the suction and discharge characteristics of the first lobe is 180° above the suction and discharge characteristics of the second lobe. When both pump sequences are coupled together, one has maximum discharge when the outlet is midway between two vertices, and the other has minimum discharge when the third vertex passes the outlet. A check valve at the outlet of each discharge chamber may prevent fluid reflow into the discharge chamber. The same applies to the inlets, where a check valve at the inlet of each suction chamber may prevent fluid flow from the suction chamber. It should be noted that the junction between the first lobe and the second lobe, i.e., the location where the first inner wall portion and the second inner wall portion transition to each other, should be considered to belong to both the first and second lobes, as well as both the first and second inner wall portions. It should also be noted that, at a particular phase of rotor rotation, at least three distinct parts of the rotor are in permanent sealing contact with respect to the first lobe, and at least three distinct parts of the rotor are in permanent sealing contact with respect to the second lobe, and they may share a portion, which may be a convex surface contact involving the transition from the first lobe to the second lobe.

[0069] According to one embodiment, the second inlet is in fluid communication with the inlet port, and the second outlet is in fluid communication with the outlet port.

[0070] Therefore, not only the first inlet but also the second inlet can be connected to a common inlet port, and both the first and second outlets can be in fluid communication with the outlet port, and a trochoidal drug pump device having both lobes in parallel while having a single inlet port and a single outlet port can be operated, and the parallel operating lobes and the coupling of their inlets and outlets are established internally.

[0071] According to one embodiment, a dispensing set is provided for dispensing a drug from a reservoir to a patient, the dispensing set including a trochoidal drug pump as described above, and a first fluid conductor having one end fixedly connected to an outlet port and the other end fixedly connected to a Luer lock.

[0072] Therefore, the dispensing set can be equipped with a drug pump device without requiring additional joints between the pump device and the conduit. This can help avoid impurities and keep the number of possible connection joints to a minimum. Furthermore, it can prevent the medical pump device from being unintentionally reused, because the dispensing set is not clearly intended for reuse and disposal, and therefore the medical pump device is not either. This makes the overall operation of the dispensing set safer.

[0073] According to one embodiment, the first fluid conduit has an upstream section and a flexible downstream section, the flexible downstream section being more flexible than the upstream section.

[0074] Therefore, the delivery set may remain more securely connected to the patient. Being more flexible means having a lower bending moment, in other words, being more stable with respect to bending, requiring less force to bend it to a certain degree along a given length. The flexible downstream compartment closer to the patient allows for compensation of movement of the drug pump device and unintentional separation of the delivery set from the patient.

[0075] According to one embodiment, the first fluid conduit is made of a flexible tube of substantially constant diameter and wall thickness, and the flexible downstream section is formed by a pre-formed helical winding of the flexible tube, the geometric shape of which results in greater flexibility than the non-helical section.

[0076] Therefore, it is possible to compensate not only for the movement of the medical pump device over the patient in the lateral direction, i.e., perpendicular to the extension of the conduit, but also for the movement of the medical pump device over the patient in the longitudinal direction, i.e., along the extension of the conduit. It should be noted that this may include embodiments in which the upstream section has a low-diameter winding, i.e., a helical winding with lower flexibility, and the downstream section has a high-diameter winding, i.e., a helical winding with higher flexibility.

[0077] According to one embodiment, the supply set further includes a second fluid conduit having one end fixedly connected to an inlet port and the other end fixedly connected to a connector adapted to be releasably connected to a fluid reservoir.

[0078] Therefore, the dispensing set can be equipped with a drug pump device without requiring an additional joint between the pump device and the conduit to the reservoir. This can help avoid impurities and maintain a low number of possible connection joints. Furthermore, it can prevent the medical pump device from being reused unintentionally, because the dispensing set is clearly not meant to be reused and discarded, nor is the medical pump device. This makes the overall operation of the dispensing set safer. It should be noted that the dispensing set may also be a fixedly connected drip volume between the reservoir and the drug pump device.

[0079] According to one embodiment, the supply set further includes a second fluid conduit having one end fixedly connected to an inlet port and the other end fixedly connected to a pre-filled fluid reservoir.

[0080] Therefore, a safe dispensing set with a minimum number of connections and points where impurities may enter may be provided. The drug pump device may be adapted to the fluid in a pre-filled reservoir, so the viscosity of the fluid matches the design of the drug pump device. Any reuse can be avoided, which is particularly relevant for highly susceptible drugs and serious illnesses. The pre-filled reservoir may contain a predefined composition of the drug. Misalignment of the drug, especially the fluid and the pump can be avoided.

[0081] According to one embodiment, the pre-filled reservoir is a gas-free volume filled with liquid.

[0082] Therefore, gas aspiration can be avoided, and it can be ensured that fluid is always delivered after rotation, regardless of the reservoir's fill level. Because the trochoidal drug pump device can also aspiration from a specific height due to its structure, the reservoir can also be positioned lower than the trochoidal drug pump device. This makes patient handling easier, especially when the drug pump device and reservoir are used as a mobile delivery system that allows the patient to carry and move around.

[0083] According to one embodiment, the dispensing set further includes a tag that represents a liquid in a pre-filled reservoir and is adapted to be read by a tag reader of a drug pump drive device.

[0084] Therefore, the operation of a trochoidal drug pump device may be adapted to the type of fluid or liquid in the reservoir. Some liquids may have specific properties that enable a defined driving dynamic that can be set based on a reading tag, so the drug pump may be adapted not only to the liquid but also to the operation of the drug pump device, such as the rotational speed or the rate of change of the rotational speed. This may be particularly relevant when the liquid is a non-Newtonian fluid or contains a non-Newtonian fluid.

[0085] It should be noted that the above embodiments may be combined, and in the combined form, they may provide synergistic technical effects and synergistic benefits that exceed the sum of the individual technical effects and benefits. [Brief explanation of the drawing]

[0086] The present invention will be explained with reference to the following drawings.

[0087] [Figure 1] A schematic build-up in a top view of a trochoidal drug pump device according to an exemplary embodiment is shown. [Figure 2] A rotor core for a pump rotor used in a trochoidal drug pump device according to an exemplary embodiment is shown. [Figure 3] This shows a pump rotor having an overmolded core used in a trochoidal drug pump device according to an exemplary embodiment. [Figure 4] A top view of a trochoidal drug pump device with the cover removed, according to an exemplary embodiment, is shown. [Figure 4A] The rotor and pump body are shown in specific relative positions according to an exemplary embodiment. [Figure 5] An exploded view of a coverless trochoidal drug pump device according to another exemplary embodiment is shown. [Figure 5A] An exemplary embodiment shows a cover / lid that encloses the pump chamber. [Figure 6] A schematic build-up in a top view of a trochoidal drug pump device according to another exemplary embodiment is shown. [Figure 7] An exemplary embodiment shows a dispensing set comprising a connected liquid / fluid reservoir and a trochoidal drug pump device. [Figure 8] An exemplary embodiment shows a dispensing set comprising a connected liquid / fluid reservoir and a trochoidal drug pump device connected to a drive unit. [Figure 9] An exemplary embodiment shows a supply set comprising a fluid conduit to be connected to a patient and a fluid conduit to be connected to a liquid reservoir.

[0088] It should be noted that identical or similar reference numerals indicate identical or similar components. Exemplary embodiments of the present invention are described below with reference to these figures. [Modes for carrying out the invention]

[0089] The present invention will be described in accordance with exemplary embodiments, which are shown in the above reference figures and will be described in detail below.

[0090] Figure 1 shows a schematic build-up in a top view of a trochoidal medicament pump device according to an exemplary embodiment. The trochoidal medicament pump device 200 has an in-port 201 and an out-port 202. The in-port receives the fluid or liquid to be pumped, and the out-port delivers the fluid or liquid to be delivered. The in-port and out-port may have a release coupling or may be fixedly connected to a conduit or the like. The trochoidal medicament pump device 200 has a pump body 220, which may have a housing 220a and a cover 220b. The housing 220a and cover 220b shown in Figure 9 define a pump chamber 225 within the pump body 220. The pump chamber 225 rotates a pump rotor 230 inside it. The pump rotor 230 is triangular when viewed from above. Viewed from above, the triangular shape has three vertices 231 and a convex curve 232 between each pair of vertices. When viewed as a three-dimensional object, the vertices 231 are vertex lines 231a extending parallel to the axis of rotation of the pump rotor 230, and the convex curve 232 is a convex surface 232a extending between the vertex lines 231a. The vertex lines 231a and the convex curve 232a are in contact with the wall portions 227a and 227b of the pump chamber 225. The vertex line 231a is always in contact with one of the wall portions 227a and 227b. The pump chamber 225 has two lobes 226a and 226b. As the pump rotor 230 rotates within the pump chamber 225, the contact between the pump rotor 230, particularly its vertex line 231a and convex curved surface 232a, and the wall portions 227a and 227b of the lobes 226a and 226b rotates with the eccentrically rotating pump rotor 230 and continues to communicate with the inlet 221a and outlet 222a, forming a chamber. The vertex 231 of the eccentrically rotating pump rotor 230 traces a trochoidal line corresponding to a trochoidal shape that is equal to or larger than the corresponding internal dimensions of the pump chamber 225.When connected to inlet 221a or one of the inlets 221a, the chamber operates as a suction chamber 228a. As the chamber rotates, its volume continuously expands, and the chamber draws fluid or liquid from the inlet port 201. After rotation, the suction chamber rotates until it exits inlet 221a. The chamber then communicates with outlet 222a and becomes a discharge chamber 229a. After further rotation, the discharge chamber 229a continuously decreases its volume, thus discharging fluid through outlet 222a until it reaches a minimum value where the volume may be close to zero. Simultaneously, the following geometric shapes of the rotor 230 proceed similarly, so the next chamber becomes a discharge chamber 229a and discharges the next amount of fluid after rotation of the pump rotor 230. After the eccentric rotation of the rotor 230 and after the volume has been filled with the liquid to be pumped, the first inlet 221a is closed by one of the vertices 231 so that the liquid can be supplied to the first outlet 222a. Between closing the volume, i.e., closing the first inlet 221a, and reopening the volume, i.e., opening the first outlet 222a, there exists a rotational difference α between the rotational position of the pump rotor 230 when one vertex has just intersected the first inlet 221a and the rotational position of the pump rotor 230 when another vertex 231 has just begun to intersect the first outlet 222a. This is a kind of overlap while the volume is being closed. Since the volume changes due to the trochoidal shape of the lobes, this overlap may be kept low, but still ensure that the volume remains closed. This overlap may be 4° or less, in particular 10° or less, and in particular between 6° and 10°.

[0091] Figure 2 shows a rotor core 236 for a pump rotor 230 for use in a trochoidal drug pump device 200 according to an exemplary embodiment. The rotor core forms a stable structure and provides a rigid geometric shape for driving the pump rotor 230 and for holding it in the correct position and trajectory after eccentric rotation. For this purpose, the pump rotor 230, in particular its rigid core 236, has a sliding surface or guide surface 234a on the pump rotor 230, in particular on the rigid rotor core 236 of the pump rotor 230, which receives the eccentric movement disk 235a of the drive pinion 235, and the eccentric rotation disk 235a presses the pump rotor 230 into an eccentric trajectory. The pump rotor 230, in particular its rigid core 236, also has a gear section 234b, which meshes with the gear section 224b of the gear wheel 224 on the pump body 220, in particular the housing 220a, and rotates the pump rotor 230 after eccentric movement. The meshing can be seen in Figure 4, where the pinion 235 and its eccentric rotating disk 235a are removed. The design of the drive pinion 235 can be seen in Figure 5. The rigid core 236 may have an undercut geometric shape 236a, which allows the overmolded 237 to be securely connected to the rigid core. According to one embodiment, the rigid rotor core has an undercut geometric shape 236a, and the undercut geometric shape 236a along each convex curve 232 has an undercut geometric shape 236a perpendicular to the rotor's axis of rotation. Each along rigid rotor core 236 may have a plurality of recesses 236b adapted to provide access for the overmolded to the undercut geometric shape 236a. The core 236 having an undercut geometric shape provides a maximized undercut with a maximized surface for chemical bonding, such as adhesive, as well as a narrow opening, so that the overmolded elastic material 237 cannot slip back through the slots, even under high pressure and high tensile force applied to the overmolded material. Smaller recesses 236b and wider recesses 236b may be provided to offer secure mechanical fastening of an elastic material, such as an LSR.The dimensions of the slots, i.e., the gap width, depend on the elastic and shear forces of the elastic overmolding material. Cylindrical holes parallel to the axis of rotation may be provided. The upper and lower portions of the overmolding may be fixed under an undercut geometric shape. The dimensions of these holes may depend on the flow index and shear force of the unspecified overmolding material.

[0092] Figure 3 shows a pump rotor with an overmolded core for use in a trochoidal drug pump device according to an exemplary embodiment. The core 236 contributes to a stable, defined geometric shape for driving the pump rotor 230. The elastic or elastomeric overmolding 237 helps seal the pump rotor 230 to the pump chamber 225, and is particularly useful for sealing the wall sections 227a, 227b of the housing 220a, the bottom of the housing 220a, and the cover 220b of the housing. As shown in Figure 5, the vertex line 231a seals the wall sections 227a, 227b, while the convex curve 232 seals the cover 220b and the bottom of the housing 220a. The pump rotor 230 having the core 236 and overmolding 237 may be manufactured in a 2K manufacturing process. The core may be made of, for example, reinforced polyetherketone PEEK or reinforced polyethylene terephthalate PET. The core may be made from other materials that are sufficiently rigid, such as PBT. The rotor core may be made from a material filled with reinforcing fibers for greater stability. The rotor core may be made from a material containing PBT and 30+ / -10 wt% glass fibers. Carbon fibers may be used instead of glass fibers. The aforementioned materials for the core have shown good compatibility with the overmolding material. The overmolding 237 may be made from liquid silicone rubber LSR, ethylene propylene diene monomer rubber EPDM, thermoplastic elastomer TPE, thermoplastic polyurethane TPU, butyl rubber, and nitrile rubber. The aforementioned materials have good compatibility with the selected material for the core 236, but also with the materials for the pump body 220, particularly the housing 220a and cover 220b. Compatibility with the pump body 220 includes compatibility with respect to the resistivity of the chemicals, compatibility with the viscosity of the chemicals, and friction between the materials of the overmolding 237 and the pump body 225.It should be noted that this applies to the pump body 225, which has two or more material compositions comprising a specific material for the pump body 225 and other materials for wall compartments 227a, 227b, their bottom and cover 220b, i.e., the part of the body that comes into contact with the pump rotor 230, in particular its overmolded 237. The overmolded 237 may be made of a biocompatible material that does not denature or release substances when in contact with biological materials or pharmaceuticals. The pump body 225 or at least the part facing the pump volume may also be made of a biocompatible material that does not denature or release substances when in contact with biological materials or pharmaceuticals. The overmolded 237 may include a gas reservoir or blister 237a for volume compensation of the volume covered by the rotor 230 and the pump chamber 225. After the rotor 230 rotates, the covered volume may change due to the trochoidal internal shape of the pump chamber. Since pumped liquids or fluids typically have low compressibility, it may be desirable to compensate for volume changes to avoid greater overpressure or underpressure in the pumped liquid or fluid. A gas reservoir may compensate for volume changes without adding greater overpressure or underpressure to the pumped liquid or fluid, as it may expand or compress after volume changes when covered or surrounded by an LSR, allowing the LSR surface between the vertices to expand or compress. The gas reservoir 237a may be completely covered by an LSR as a blister. The gas reservoir 237a may be sealed between the surface of the core 236 and the surface of the overmolded 237. The larger the gas volume relative to the volume change, the lower the overpressure or underpressure added to the liquid or fluid. It should be noted that each compartment between two vertices may have its own sealed gas reservoir 237a.It should be noted that since the tree gas reservoirs 237a may be connected to each other by conduits or tubes, the entire resulting gas reservoir may be shared.

[0093] Figure 4 shows a top view of the trochoidal drug pump device 200 with the cover removed according to an exemplary embodiment. Figure 4 shows the trochoidal drug pump device with the removed cover 220b and the removed drive pinion 235. After rotation in a planetary gear manner around a gear wheel 224 fixed to the pump body 220, the apex 231 of the pump rotor 230 follows the trochoidal shape of the pump chamber 225, particularly its wall portion 227a on the right side in Figure 4. The apex line 231a seals the pump rotor 230 over the inner wall portion, which forms the suction chamber 228a and the discharge chamber 229a, respectively. The fluid to be pumped and delivered enters the pump chamber 225 above the inlet 221a and leaves the pump chamber 225 above the outlet 222a. The situation illustrated in Figure 4 is the transition from the suction chamber 228a to the discharge chamber 229a. It can be seen that one of the vertices 231 has just passed the inlet 221a, thus closing the chamber and ending the suction phase, before the advancing vertex 231 has passed the outlet 222a and thus the chamber for discharging the fluid is opened. It should be noted that the vertices 231 also follow the other side, i.e., the wall compartment 227b on the left side in Figure 4. However, in the embodiment shown in Figure 4, which corresponds to the embodiment shown in Figure 1, only one inlet 221a and only one outlet 222a are provided in the right lobe 226a. The other lobe 226b on the left side has no inlet and outlet, so a vacuum is created in each of the suction chambers 228b on the left side after rotation. At the same time, a pressure is created in the discharge chamber 229b on the left side after rotation. The vacuum in chamber 228b and the excessive pressure in chamber 229b cause increased load and friction on the rotor 230, so these vacuums and pressures should be avoided, respectively. If further inlets and outlets are not used for pumping and delivery, then further inlets and outlets should be avoided, and the pressure difference is compensated through a notch 227c that runs along a specific section of the left-hand wall section 227b in Figure 4. The notch bypasses the sealing of the apex 231 in the inner wall section 227b, allowing the overpressure from the discharge chamber to be compensated by passing through the vacuum in the suction chamber 228b.Therefore, the pressure difference can be compensated, and friction and load can be reduced. The notch may be formed by a chamfer, as shown in Figure 4. The chamfer may have a rounded edge, at least on the side where the vertex line contacts the edge of the chamfer. The notch may be realized by a groove along the inner wall portion 227b, or even by a bypass channel having one opening in the region of the suction chamber 228b and another opening in the region of the discharge chamber 229b.

[0094] Figure 4A shows the rotor 230 and pump body 220 in specific positions relative to each other. From Figure 4A, it can be seen that after rotation, at least one vertex 231 is located between the ends of the first inlet 221a and the first outlet 222a in the first inner wall portion 227a of the pump volume of the pump chamber 225. The rotational difference α between the rotational position of the pump rotor 230 just after one vertex has passed the first inlet 221a and the rotational position of the pump rotor 230 just after the other vertex 231 has begun to pass the first outlet 222a is 12° or less, particularly 10° or less, and particularly between 6° and 10°. This overlap ensures that the inlet is always closed before the outlet opens to avoid backflow of the liquid to be pumped. Since manufacturing results in specific tolerances, the overlap has dimensions and can ensure that the inlet is always closed before the outlet opens, even in the worst-case match of the manufacturing means.

[0095] Figure 5 shows an exploded view of a trochoidal drug pump device without cover 220b according to another exemplary embodiment. The position of cover 220b is shown in Figure 9. It should be noted that the trajectory of the pump rotor 230 is defined by an eccentric disk 235a, which is shown in Figure 5 and omitted in Figure 4 for illustrative purposes. The eccentric rotating disk 235a presses the pump rotor 230 onto the eccentric path after the central rotation of the pinion 235 and its drive coupling 235b. The eccentric disk 235a is rotatably mounted on the rotor 230, in particular on the corresponding bearing surface 234a on its core 236. During eccentric rotation, the gear section 234b of the pump rotor 230 remains engaged with the gear section 224b of the gear wheel 224 of the pump body, and as the pump rotor 230 rotates as well as eccentrically moves along the eccentric path, the apex follows the trochoidal path of the first and second lobes 226a, 226b and the corresponding wall sections 227a, 227b. As can be seen in Figure 5, the gear wheel 224 is provided as a separate element, but it has projections 224c that engage with fasteners 220c in the pump body so that the gear wheel 224 is fixed onto the pump body. Fixation can also be achieved by other means such as adhesive, positive mating connections, or by providing the gear wheel 224 integrally with the pump body 225. For the remaining elements in Figure 5, please refer to the figures above.

[0096] The pump rotor 230 has an overmolded 237 which is larger in dimensions than the pump chamber with respect to the portion that contacts the wall portions 227a, 227b of the pump chamber 225, so that the stretchable or elastic overmolded 237 is compressed to provide a reliable seal. These contact portions are the apex line 231a of the rotor 230 and also the portion of the convex curved surface 232a that contacts the inner wall portions 227a, 227b, in particular the transition from the first wall portion 227a of the first lobe 226a to the second wall portion 227b of the second lobe 226b. The stretchable or elastic material of the overmolded 237 may be selected from a first class of materials, which may consist of liquid silicone rubber (LSR), ethylene propylene diene monomer rubber (EPDM), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), butyl rubber, and nitrile rubber. In particular, when the overmold 237 is made of liquid silicone rubber (LSR), the LSR is designed to have a hardness between 10 and 100 Shore (ShA), especially between 50 and 100 Shore (ShA), and especially between 60 and 70 Shore (ShA). The hardness in some examples depends on the expected pressure of the fluid and the viscosity of the fluid to be pumped. Alternatively, the overmold may be made of medical-grade TPE (thermoplastic elastomer), and the TPE overmold 237 is designed to have a hardness between 29 and 90 Shore (ShA), especially between 40 and 80 Shore (ShA), and especially between 50 and 70 Shore (ShA). As a further alternative, the overmolding may be made of TPU (thermoplastic polyurethane), and the TPU overmolding 237 is designed to have a hardness between 29 and 90 Shore (ShA), particularly between 40 and 80 Shore (ShA), and especially between 50 and 70 Shore (ShA). The hardness in some examples depends on the expected pressure of the fluid and the viscosity of the fluid to be pumped.

[0097] LSR has a hardness of 50-60 Shore A and a hardness of 1.1 g / cm³. 3 ~1.2g / cm 3It may have a density of . The LSR may be a self-lubricating LSR that releases lubricant in a controllable manner. The self-lubricating LSR may be a biocompatible LSR.

[0098] LSR is a hardness of 55 according to DIN 53 505 Shore A, and 1.13 g / cm³ according to DIN 53 479 A. 3 The density is 8 N / mm² according to DIN 53 504 S2. 2 This may be Momentive's Silopren® LSR 4655 SL, as specified on April 7, 2016, having a tensile strength of 450% elongation at break according to DIN 53 504 S2 and a tensile strength of 45 N / mm according to ASTM D 624 B.

[0099] LSR is Shore A, hardness 60 according to DIN ISO 48-4, and 1.12 g / cm³ according to DIN EN ISO 1183-1A. 3 Density, 9.0 N / mm² according to ISO 37 Type 1. 2 Wacker's SILPURAN® 6600 / 60 A / B, as specified November 11, 2022, may have a tensile strength of 310% elongation at break according to ISO 37 Type 1 and a tensile strength of 26 N / mm according to ASTM D 624 B.

[0100] LSR is Shore A, hardness 50 according to DIN ISO 48-4, and 1.10 g / cm³ according to DIN EN ISO 1183-1 A. 3 The density is 8.4 N / mm² according to ISO 37 Type 1. 2 Wacker's SILPURAN® 6760 / 50 A / B, as specified November 11, 2022, may have a tensile strength of 600% elongation at break according to ISO 37 Type 1 and a tensile strength of 27 N / mm according to ASTM D 624 B.

[0101] The self-lubricating LSR may be adapted to allow the rotor 230 to rotate at least 6000 revolutions per minute within the pump body 220. Depending on the application, the self-lubricating LSR may be adapted to allow the rotor 230 to rotate between 1500 and 6000 revolutions per minute within the pump body 220, particularly between 3000 and 4000 revolutions per minute.

[0102] It has become clear that a significant number of infusions are based on liquids / liquids with a viscosity close to that of water, which is approximately 1 cP for water at 20°C at a flow rate of 500 ml / h. For example, when using a small cannula such as a 31G needle cannula with an inner diameter of 0.11 mm, the exemplary internal pressure in an exemplary pump chamber is between 6 and 7 bar.

[0103] The hardness may also depend on the material used for the pump body 225, particularly the material used for the inner wall compartments 227a, 227b, bottom and cover 220b of the pump body 220. These compartments may be manufactured from a second class of materials, which consists of polyethylene terephthalate (PET), polycarbonate (PC), tritan, high-density polyethylene (HDPE), cycloolefin copolymer (COC), PBT, PPS, and PEI. When tritan is used, the biocompatible material may be tritan mixed with a medical-grade absorbent. The absorbent is a light absorber that absorbs light radiation at a specific wavelength or wavelength spectrum. The absorbent may absorb wavelengths between 960 nm and 1000 nm, particularly wavelengths between 980 nm and 10 nm. The absorbent is adapted in particular to absorb the light radiation of a welding laser, so that the laser light is absorbed and efficiently converted into heat and melting of the material for welding purposes. The internal dimensions of the pump chamber 225, particularly the inner wall portions 227a and 227b, and the external dimensions of the pump rotor 230, particularly its overmolded 237, may also depend on the predicted fluid pressure and viscosity. The external dimensions of the pump rotor 230 with the overmolded 237 may be larger by a factor than the corresponding internal dimensions of the contact portion of the pump chamber 225, the factor being between 1.01 and 1.1, particularly between 1.01 and 1.05, and particularly between 1.01 and 1.03. This means that the oversize due to this factor must be compensated for by the elastic or resilient material of the overmolded 237. Since the overmolded has smaller dimensions than the entire rotor 230, and the core 236 is not elastic or resilient, or has only less elastic or resilient material, the elastic or resilient material of the overmolded needs to be more elastic or resilient than the factor mentioned above alone would allow. Elasticity can occur in different directions, namely radial and axial. This is because the acting frictional forces have different directions, and the seal along the vertex line 231a is shorter than the convex curved seal line 232.Furthermore, the movement of the rotor 230 generates transverse forces along the vertex line 231a, while the forces along the convex curve 232 are at least partially aligned with the extension of the convex curve seal line. Thus, the coefficient in the radial direction may be between 1.01 and 1.1 (i.e., an increase of 1 to 10%), particularly between 1.01 and 1.05 (i.e., an increase of 1 to 5%), and particularly between 1.02 and 1.03 (i.e., an increase of 2 to 3%), while the coefficient in the axial direction may be between 1.01 and 1.1 (i.e., an increase of 1 to 10%), particularly between 1.01 and 1.05 (i.e., an increase of 1 to 5%), and particularly between 1.01 and 1.03 (i.e., an increase of 1 to 3%). The relationship between the rate of increase of the radial coefficient and the rate of increase of the axial coefficient (the rate of increase of the axial coefficient divided by the rate of increase of the radial coefficient) can be between 1 and 10 (i.e., between 1% / 1% and 10% / 1%), especially between 1 and 5 (i.e., between 1% / 1% and 5% / 1%), and especially between 2 and 3 (i.e., between 2% / 1% and 3% / 1%).

[0104] Figure 5A shows a cover / lid 220b covering the pump chamber according to an exemplary embodiment. The cover 220b covers and seals the pump chamber 225. If the first lobe is used as the pumping volume and the second lobe is not used as the pumping volume, the cover 220b in the region over the second lobe 226b may have a recessed area 220d or recessed area that is axially recessed compared to the region over the first lobe 226a. The outer dimensions of the pump rotor 230 with the overmolding in this region may remain larger than the corresponding inner dimensions of the contact portion of the pump chamber 225 so that sealing remains. However, the coefficient by which the outer dimensions of the pump rotor 230 with the overmolding in this region are larger than the corresponding inner dimensions of the contact portion of the pump chamber 225 is smaller than the coefficient in the region of the first lobe 226a. Thus, the friction in the region of the second lobe may be lower than the friction in the region of the first lobe. Since pumping occurs only in the first lobe, the oversize factor that results in sealing is necessary in the region of the first lobe but not in the second lobe. It should be noted that the dimensions of the cover 220b and its recess 220d bay are designed so that there is no oversize factor that would lead to further reduction of friction in the region of the second lobe. If friction is reduced in the second lobe, the overall friction is also reduced, resulting in reduced driving force and more precise delivery of the fluid by the pump. The axially recessed recess 220d in the region on the second lobe 226b may be between 0.01mm and 0.2mm, particularly between 0.05mm and 0.15mm, particularly 0.1mm+ / 0.04mm. Interfaces 220e and 220f between the pump chamber 225 and the cover 220b may result in a specific mounting position of the cover 220b on the pump chamber 225. The interface may be formed by the unique external shape of the cover 220b and / or by a keyhole projection 220f on the cover 220b or a corresponding part on the side of the cover or pump chamber 225 that engages with the keyhole 220e, respectively, so that the cover 220b can be positioned on the pump chamber 225 in only one position.The cover 220b may have an axially projecting rim 220g that protrudes from the side of the cover facing the pump chamber 225, for easier and more reliable assembly of the cover.

[0105] Figure 6 shows a schematic build-up in a top view of a trochoidal drug pump device according to another exemplary embodiment. The trochoidal drug pump device 200 shown in Figure 6 is similar to the device shown in Figure 1. In addition to what has been described with respect to Figure 1, the trochoidal drug pump device 200 of Figure 6 has not only an inlet 221a and an outlet 222a on the first lobe 226a, but also an additional inlet 221b and an outlet 222b on the second lobe 226b. This allows the second lobe to also be used as a pump that may operate in parallel with the pump formed on the first lobe 226a. Both the first inlet 221a and the second inlet 221b may be in fluid communication with the inlet port 201. At the same time, the first outlet 222a and the second outlet 222b may be in fluid communication with the outlet port 202. Thus, both pump paths can be coupled via a common inlet port 201 and a common outlet port 202. The inlet port 201 receives the fluid or liquid to be pumped, and the outlet port 202 delivers the fluid or liquid to be delivered. The inlet and outlet ports may have a releaseable coupling, or they may be fixedly connected to a conduit or the like. The triangular pump rotor 230 moves as described above. The vertex line 231a and the convex curve 232a are in contact with the wall portions 227a and 227b of the pump chamber 225. The vertex line 231a is always in contact with one of the wall portions 227a and 227b. The pump chamber 225 has two lobes 226a and 226b. As the pump rotor 230 rotates within the pump chamber 225, contact between the pump rotor 230, particularly its vertex line 231a and convex curved surface 232a, and the wall sections 227a and 227b of the lobes 226a and 226b forms a chamber, which rotates with the eccentrically rotating pump rotor 230 and is then connected to the first inlet 221a, the first outlet 222a, the second inlet 221b, and the second outlet 222b. Upon connection to the respective inlets 221a and 221b, the chambers operate as suction chambers 228a and 228b. As the chambers continuously expand their volume after rotation, they draw fluid or liquid from the inlet port 201.After rotation, the suction chamber rotates until it exits its respective inlets 221a and 221b. The chamber then connects with its respective outlets 222a and 222b, becoming the discharge chambers 229a and 229b. After further rotation, the discharge chambers 229a and 229b continuously decrease in volume, thus discharging fluid through outputs 222a and 222b until they reach their minimum value, which may be close to zero. Simultaneously, the following geometric shapes of the rotor 230 proceed in a similar manner, so that the next chambers become the discharge chambers 229a and 229b, discharging the next amount of fluid after rotation of the pump rotor 230. The in-flow follows the dashed lines and arrows in Figure 6, and the outflow follows the dashed lines in Figure 6.

[0106] Figure 6 further shows that the rotor 236 may have an internal sealing seal lip 238 located on at least one bottom or top side of the rotor 236, oriented toward the cover, and the internal sealing lip 238 may cover and seal the top or bottom cover. The internal sealing lip 238 is located radially on each side between the gear section 234b of the rotor 236 and the convex curve 232, forming an additional backup seal in addition to the main sealing line along the convex curve. The internal sealing lip 238 may be set rearward relative to the main seal so that it has lower friction along the convex curve than the main seal. The internal sealing lip 238 may function as a safety seal to prevent the ingress of air or contaminants that may pass through the eccentric opening. This lip may be cylindrically positioned around the eccentric bearing and set rearward relative to the main seal, where there is less pressure on the housing. The internal sealing lip may be made from the same material as the rest of the overmolding, may be manufactured in the same injection molding process, and may be connected through channels through which the material flows during injection molding.

[0107] As can be seen from Figure 6, the first suction chamber 228a is at the minimum volume to initiate the suction process, and the second suction chamber 228b is at the maximum volume to nearly complete the suction process. Similarly, the first discharge chamber 229a is at the maximum volume to initiate the discharge process, and the second discharge chamber 229b is at the minimum volume to nearly complete the discharge process. Since the discharge process is not linear and has a break between peaks as it passes through each output, a single pump has discontinuous feeding after continuous rotation of the pump rotor 230. However, since the pump's discharge process in the first lobe 226a is phase-shifted over the discharge process in the second lobe 226b, the interruption can be compensated for. Therefore, no interruption occurs at the outlet port 202. To avoid unintended backflow of fluid into the chambers, check valves or flow resistors (not shown in Figure 6) that prevent or reduce unintended backflow may be provided.

[0108] Figure 7 shows a dispensing set having a connected liquid / fluid reservoir and a trochoidal drug pump device according to an exemplary embodiment. The trochoidal drug pump device is as described above with respect to Figures 1 to 6. A dispensing set is a device used to apply medication to a patient. Conventional dispensing sets are known and may include a connection to a reservoir, a connection to a patient, and a dispensing facility for setting the flow rate. Dispensing set 300 includes a trochoidal drug pump device 200, and further has a first fluid conduit 310 for connecting the trochoidal drug pump device 200, in particular its outlet port 202, to a patient 400. Similarly, dispensing set 300 has a second fluid conduit 340 for connecting the trochoidal drug pump device 200, in particular its inlet port 201, to a reservoir 370. The dispensing set 300 shown in Figure 7 has a reservoir 370 fixedly connected to the second fluid conduit 340. The first end 341 of the second conduit 340 is fixedly connected to the inlet port 201 of the trochoidal drug pump device 200, and the second end 342 of the second conduit 340 is fixedly connected to the reservoir 370. This reduces joining connections and impurities in the system. The reservoir 370 may be a pre-filled reservoir 375 so that the dispensing set is ready for use in combination with the trochoidal drug pump device 200. The first conduit 310 can be connected to the patient 400 at its first end and fixedly connected to the outlet port 202 of the trochoidal drug pump device 200 at its second end 312. The trochoidal drug pump device 200 may be fitted with the fluid in the pre-filled reservoir 375. The reservoir is not typically refilled and placed so that the trochoidal drug pump device 200 is also placed and unintended reuse can be avoided. The reservoir may be a flexible volume such as a bag, and the fluid inside may not contain gas, so the fluid can be removed from the reservoir regardless of the position of the reservoir and its outlet.Since the trochoidal drug pump device 200 is aspirable, the reservoir may even be positioned lower than the trochoidal drug pump device 200, i.e., the trochoidal drug pump device 200 may even be located above reservoirs 370, 375. The supply set 300 may have a readable tag 380 that carries information representing the supply set, for example, with respect to the fluid tape, reservoir volume, type of trochoidal drug pump device 200, etc. This tag can be read by a tag reader 180 on a drive device 100 for the trochoidal drug pump device 200, as described with respect to Figure 8, for example. The tag 380 may be an RFID device, a machine-readable optical tag, or an actively transmitted tag. The tag may contain certain intelligence and may be connected to sensors that sense parameters on or of the supply set, so this information can be provided after the tag is read. The trochoidal drug pump device 200 has a coupling that is driven by the drive device 100. The coupling may be realized by the coupling portion n235 of the drive pinion as described above, and may be coupled to the drive device 100 by the coupling portion 235.

[0109] Figure 8 shows a supply set according to an exemplary embodiment, comprising a connected liquid / fluid reservoir and a trochoidal drug pump device connected to a drive unit. The supply set 300 is coupled to the drive unit 100 via the drive coupling 235 described above. The drive unit may have a tag reading facility 180 for reading or communicating with the tag 380. In this embodiment, the trochoidal drug pump device 200 is received directly in front of the drive unit to protect the trochoidal drug pump device 200, its ports 201, 202, and conduits 310, 340. The supply set 300 may be locked to the drive unit 100 to prevent unintended separation of the reservoirs 370, 375 and the trochoidal drug pump device 200 from the drive unit.

[0110] Figure 9 shows a donation set according to an exemplary embodiment, having a fluid conduit connected to a patient and a fluid conduit connected to a liquid reservoir. Figure 9 shows an implementation of the trochoidal drug pump device as described above with respect to Figures 1 to 6. The donation set 300 includes a trochoidal drug pump device 200 and further has a first fluid conduit 310 for connecting the trochoidal drug pump device 200, in particular its outlet port 202, to the patient 400. Similarly, the donation set 300 has a second fluid conduit 340 for connecting the trochoidal drug pump device 200. For this purpose, the second conduit 340 has a first end 341 connected to the trochoidal drug pump device 200, in particular its inlet port 201. The second end 342 of the second conduit 340 may be connected to reservoirs 370, 375. This can be done via a connector 360. The reservoirs 370, 375 may be fixedly connected as described above with respect to Figure 7. The supply set shown in Figure 9 for the first conduit 310 has an upstream section 320 and a downstream section 330. In the upstream section 320, the second end 312 of the first conduit 310 is fixedly connected to the outlet port 202 of the trochoidal drug pump device 200. In the downstream section 330, the first end 311 of the first conduit 310 is connectable to the patient 400, for example, via a Luer lock device 350. The downstream section 330 in this embodiment has higher flexibility than the upstream section, meaning it can be bent more easily. This is achieved in the illustrated embodiment by providing a helical winding 335, which extends the length of the conduit flow and thus allows for higher flexibility without using the stretched dimensions, because the helical winding 335 is not longer than any other comparable section and does not increase the physical distance from the reservoir to the patient. A spiral winding not only compensates for lateral bending forces with respect to longitudinal extension, but can also compensate for forces along the longitudinal extension of the first conduit. This is because the spiral winding can act like a spring. [Explanation of symbols]

[0111] 100 Drive unit for driving drug pump devices for trochoids 180 Tag reader on drive unit 200 Trochoidal drug pump devices 201 Inlet port of trochoidal drug pump device 202 Outlet port of trochoidal drug pump device 220 Pump body 220a Pump body housing 220b Pump body cover 220c Pump housing / pump body locking notch / fastener 220d Recess inside the cover 220e Keyholes that accept key protrusions for unique positioning of the cover 220f Key projection for engagement keyhole for unique positioning of cover 220g Cover protrusion (circumferential) rim for assembly 221a First inlet of the pump chamber 221b Second inlet of the pump chamber 222a First outlet of the pump chamber 222b Second outlet of the pump chamber 224 Gear Wheel 224b Gear section of the gear wheel 224c gear wheel locking protrusion 225 Pump Chamber 226a First lobe of the pump chamber 226b Second lobe of the pump chamber 227a First inner wall portion 227b Second inner wall section 227c Notch 228a First suction volume 228b Second suction volume 229a First discharge volume 229b Second discharge volume 230 Pump Rotor 231 vertices 231a Pump rotor apex line / midpoint sealing line 232 Convex curve / convex curved sealing wire of pump rotor 232a Convex curved surface 234a Rigid rotor core of pump rotor / Sliding surface / Guide surface on pump rotor 234b Rigid rotor core of the pump rotor / Gear compartment on the pump rotor 235 Drive Pinion 235a Drive pinion eccentric slide disk 235b Drive pinion drive coupling 236 Pump rotor (rigid) rotor core 236a Undercut Geometric Shape of Rotor Core 236b Recess as access for overmolding to undercut geometric shape 237 Pump rotor (stretchable or elastic) overmolding 237a (Pressurized) gas reservoir / blister located within or covered by an overmolding. 238 Inner sealing lip 300 Donation Sets 310 First fluid conduit 311 First end of the first fluid conduit 312 The second end of the first fluid conduit 320 Upstream section of the first fluid conduit 330 The (flexible) downstream portion of the first fluid conduit 335 (Flexible) spiral winding of the first fluid conduit 340 Second fluid conduit 341 First end of the second fluid conduit 342 The second end of the second fluid conduit 350 Luer lock (first end of first fluid conduit) 360 Connector at the (second) end of the second fluid conduit 370 Fluid Reservoir 375 Pre-filled fluid reservoir 380 Tags on (pre-filled) fluid reservoir 400 patients α is the (α) rotational difference between the case where the first entrance is already closed and the case where the first exit is not yet open.

Claims

1. The pump body and An entry port for the administered drug, An exit port for administering medication, The pump rotor has a triangular convex shape and has an eccentric trajectory after rotation within the pump body, The pump rotor has three equidistant vertices, and each pair of these vertices is connected by a convex curve. The pump body has a pump chamber, The pump chamber has a first lobe that forms a first inner wall portion of the pump volume of the pump chamber, a first inlet that is in fluid communication with the inlet port, a first outlet that is in fluid communication with the outlet port, and the pump rotor rotates eccentrically such that the rotor having the first wall portion forms a first suction volume that is in fluid communication with the first inlet and a first discharge volume that is in fluid communication with the first outlet after rotation. The pump rotor comprises a rigid rotor core and an elastic overmolding that covers at least the sealing line along the vertex and the sealing line along the convex curve. The overmold is made of a biocompatible elastic material of the first material class. The first inner wall portion is made of a biocompatible material of the second material class. The outer dimensions of the pump body having the overmolding are greater than the corresponding inner dimensions of the contact portion of the pump chamber. The vertex of the eccentrically rotating pump rotor follows a trochoidal curve corresponding to a trochoidal shape equal to or larger than the corresponding inner dimension of the pump chamber. Trochoidal drug pump device.

2. The trochoidal drug pump device according to claim 1, wherein the rigid rotor core has an undercut geometric shape, and the undercut geometric shape has undercuts perpendicular to the rotation axis of the rotor along each convex curve.

3. The trochoidal drug pump device according to claim 2, wherein the rigid rotor core has a plurality of recesses adapted along each convex curve to provide access for overmolding to the undercut geometric shape.

4. The trochoidal drug pump device according to any one of claims 1 to 3, wherein the first material class is comprised of liquid silicone rubber LSR, ethylene propylene diene monomer rubber EPDM, thermoplastic elastomer TPE, thermoplastic polyurethane TPU, butyl rubber, and nitrile rubber.

5. The trochoidal drug pump device according to any one of claims 1 to 4, wherein the first material class is self-lubricating liquid silicone rubber LSR.

6. The trochoidal drug pump device according to any one of claims 1 to 5, wherein the first material is a liquid silicone rubber LSR treated with a medical-grade biocompatible lubricant, particularly a medical-grade biocompatible silicone oil.

7. The trochoidal drug pump device according to any one of claims 1 to 6, wherein the overmolding is made of liquid silicone rubber LSR having a hardness of 10 to 100 Shore (ShA), particularly 20 to 80 Shore (ShA), particularly 40 to 60 Shore (ShA), and particularly 50+ / -5 Shore (ShA).

8. The trochoidal drug pump device according to any one of claims 1 to 7, wherein the rotor has an internal sealing lip provided on at least one side of the rotor perpendicular to the rotation axis of the rotor, and the internal sealing lip is provided radially on each side between the gear section of the rotor and the convex curve.

9. The trochoidal drug pump device according to any one of claims 1 to 8, wherein the second material class is comprised of polyethylene terephthalate (PET), polycarbonate (PC), thoritan, high-density polyethylene (HDPE), cycloolefin copolymer (COC), PBT, PPS, and PEI.

10. The trochoidal drug pump device according to any one of claims 1 to 9, wherein the biocompatible material of the second material class is thritane mixed with a medical-grade absorbent.

11. The trochoidal drug pump device according to claim 10, wherein the absorbent is adapted to absorb light radiation from a welding laser, particularly light radiation with wavelengths between 960 nm and 1000 nm, especially light radiation with wavelengths of 980 ± 10 nm.

12. The trochoidal drug pump device according to any one of claims 1 to 11, wherein the rotor core is made of a material from the second group of materials filled with reinforcing fibers.

13. The trochoidal drug pump device according to claim 12, wherein the rotor core is made of a material comprising PTB and 30% by weight of glass fiber.

14. The trochoidal drug pump device according to any one of claims 1 to 13, wherein the outer dimensions of the pump rotor having the overmolded are greater than the corresponding inner dimensions of the contact portion of the pump chamber by a coefficient, the coefficient being between 1.01 and 1.1, particularly between 1.01 and 1.05, and particularly between 1.02 and 1.

03.

15. The trochoidal drug pump device according to claim 14, wherein the coefficient in the radial direction is between 1.01 and 1.1, particularly between 1.01 and 1.05, and particularly between 1.02 and 1.

03.

16. The trochoidal drug pump device according to claim 14 or 15, wherein the coefficient in the axial direction is between 1.01 and 1.1, particularly between 1.01 and 1.05, and particularly between 1.02 and 1.

03.

17. Each of the convex curves has an overmolded section with a closed gas reservoir, which is under a pressure higher than atmospheric pressure, particularly 1.2 x 10⁻⁶. ５ Pa ~ 2.0 x 10 ５ The pressure is between Pa, especially 1.3 x 10 ５ Pa+ / -0.2x10 ５ A trochoidal drug pump device according to any one of claims 1 to 16, which is filled with a gas at a pressure of Pa.

18. The gas reservoir is 1 mm ３ to 20 mm ３ in between, particularly 1 mm ３ to 10 mm ３ in between, particularly 2 mm ３ ± 0.5 mm ３ and has a volume of the trochoid drug pump device according to claim 17.

19. The trochoidal drug pump device according to any one of claims 1 to 18, wherein the first inlet and the first outlet terminate at the first inner wall portion of the pump volume of the pump chamber such that, after eccentric rotation of the pump rotor, at least one of the vertices is located between the first inlet and the first outlet in the direction of rotation, and the rotational difference between the rotational position of the pump rotor just after one vertex has passed the first inlet and the rotational position of the pump rotor just after another vertex has begun to pass the first outlet is 14° or less, in particular 10° or less, in particular between 6° and 10°.

20. The trochoidal drug pump device according to any one of claims 1 to 19, wherein the pump chamber has a trochoidal shape in which the first lobe and the second lobe form a second inner wall portion of the pump volume of the pump chamber, and the pump rotor rotates eccentrically with the vertex moving along a trochoidal line corresponding to the trochoidal shape, thereby forming a second suction volume and a second discharge volume after rotation.

21. The trochoidal drug pump device according to claim 20, wherein the pump body has a cover that covers and seals the pump chamber on at least one axial side, and the cover has a recess in the region covering the second lobe that is recessed in the axial direction compared to the region covering the first lobe, so that the outer dimension of the pump rotor having the overmolded is larger by a coefficient than the corresponding inner dimension of the contact portion of the pump chamber, and the coefficient in the region of the second lobe is smaller than the coefficient in the region of the first lobe.

22. The trochoidal drug pump device according to claim 21, wherein the recess in the axial direction in the region covering the second lobe is between 0.01 mm and 0.2 mm, particularly between 0.05 mm and 0.1 mm, and particularly between 0.1 mm + / - 0.03 mm.

23. The trochoidal drug pump device according to claim 21 or 22, wherein the interface between the pump chamber and the cover provides a unique mounting position for the cover on the pump chamber.

24. The trochoidal drug pump device according to claim 23, wherein the interface is formed by a keyhole projection on the cover that engages with a keyhole on the side of the pump chamber, so that the cover can be positioned on the pump chamber in only one position.

25. The trochoidal drug pump device according to any one of claims 21 to 24, wherein the cover comprises an axially projecting rim that protrudes from the side surface of the cover facing the pump chamber.

26. The trochoidal drug pump device according to any one of claims 20 to 25, wherein the second inner wall portion has at least a notch in the cross-sectional direction formed in the second inner wall portion in the circumferential direction, and after rotation of the pump rotor, a pressure compensation bypass is formed between the second discharge volume and the second suction volume.

27. The trochoidal drug pump device according to any one of claims 20 to 26, wherein the pump chamber within the pump volume of the second lobe has a second inlet that is in fluid communication with the inlet port and a second outlet that is in fluid communication with the outlet port, and the pump rotor rotates eccentrically such that at least three distinct portions of the rotor are in permanent sealing contact with the first inner wall portion of the first lobe and the second inner wall portion of the second lobe, thereby forming, after rotation, a second suction volume in fluid communication with the second inlet and a second discharge volume in fluid communication with the second outlet, in particular the second inlet being in fluid communication with the inlet port and the second outlet being in fluid communication with the outlet port.

28. A dispensing set for providing medication from a reservoir to a patient, A trochoidal drug pump according to any one of claims 1 to 27, A first fluid conductor having one end fixedly connected to the outlet port and the other end fixedly connected to at least one of a connector, particularly a Luer lock and an ENFIT, is included. Provision set.

29. The first fluid conduit has an upstream section and a flexible downstream section, the flexible downstream section being more flexible than the upstream section, and in particular the first fluid conduit is made of a flexible tube of substantially constant diameter and wall thickness, the flexible downstream section is formed by a preformed helical winding of the flexible tube, the geometric shape of the helical winding provides greater flexibility than the unwinding section, the supply set according to claim 28.

30. The supply set according to claim 28 or 29, further comprising a second fluid conduit having one end fixedly connected to the inlet port and the other end fixedly connected to a connector adapted to be releasably connected to a fluid reservoir.

31. The supply set further includes a second fluid conduit having one end fixedly connected to the inlet port and the other end fixedly connected to a pre-filled fluid reservoir, wherein the pre-filled reservoir is a gas-free volume pre-filled with liquid, according to any one of claims 28 to 30.

32. The dispensing set according to any one of claims 28 to 31, further comprising a tag that represents the liquid in the pre-filled reservoir and is adapted to be read by a tag reader of a drug pump drive device.

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