DELIVERY DEVICE

Abstract

A delivery device for administering a drug includes a housing, a reservoir and a drive device with a movable piston rod. The piston rod is guided through an aperture in an inner or outer wall of the housing. The aperture is sealed but allows the piston rod to move. The shape of the circumference of the cross-section of the piston rod is approximately a non-trivial curve of constant width.

Claims

1. A delivery device for delivering a fluid drug, comprising: a housing comprising a reservoir module and a drive module configured to be detachably connected; a reservoir configured with a variable internal volume for storing the fluid drug, wherein the reservoir is at least partially arranged in the reservoir module of the housing; a drive device at least partially arranged in the drive module of the housing, the drive module comprising: a drive, the drive comprising a motor or a spring; and a movable piston rod mounted in the housing and configured to be movable by the drive to change the variable internal volume of reservoir, wherein the piston rod is configured to be guided via an aperture through at least one of an inner wall of the housing, an outer wall of the reservoir module, or an outer wall of the drive module, wherein the piston rod is displaceably and non-rotationally mounted in the aperture, wherein a bearing surface between the piston rod and the aperture comprises an elastically deformable seal configured to prevent liquid from passing through the aperture while permitting displacement of the piston rod, and wherein a shape of a circumference of a cross-section of the piston rod is approximately a non-trivial curve of constant width.

2. The delivery device according to claim 1, wherein the curve of constant width is a curve of constant width with three or more corners.

3. The delivery device according to claim 2, wherein the curve of constant width comprises five corners or seven corners.

4. The delivery device according to claim 1, wherein the curve of constant width is a curve of constant width with rounded corners.

5. The delivery device according to claim 1, wherein a housing of the reservoir module and a housing of the drive module are configured to be detachably connectable to each other, wherein at least a portion of the housing of the drive module is constructed of a two-component injection molded material in an area of the outer wall comprising the aperture, wherein a material of a first component defining the outer wall differs from a material of a second component defining the seal.

6. The delivery device according to claim 5, wherein the material of the second component is a thermoplastic elastomer.

7. The delivery device according to claim 6, wherein the thermoplastic elastomer comprises at least one of a thermoplastic polyurethane or a thermoplastic polyamide.

8. The delivery device according to claim 5, wherein the material of the second component is a silicone.

9. The delivery device according to claim 5, wherein a region of the outer wall comprising the aperture comprises at least one additional aperture comprising at least one additional seal, and wherein the at least one additional seal is constructed of the material of the second component of the two-component injection molded material.

10. The delivery device according to claim 9, wherein a seal component defines the seal and the at least one additional seal, wherein the seal and the at least one additional seal are coupled by at least one arm of the seal component.

11. The delivery device according to claim 9, wherein the at least one additional aperture is configured as an aperture for at least one of an operating element or for one or more electrical contacts.

12. The delivery device according to claim 1, wherein the delivery device is an infusion pump.

13. The delivery device according to claim 12, wherein the infusion pump is a patch pump.

14. The delivery device according to claim 1, wherein the delivery device is an injection device.

15. The delivery device according to claim 14, wherein the injection device is a pen-shaped injection device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Implementations are described in connection with the appended figures, which are exemplary and are in no way to be interpreted as limiting.

[0033] FIGS. 1 to 3 show the prior art according to the preceding explanations provided in the Background.

[0034] FIGS. 4 and 5 show details of the various forms of the curve of constant width, according to the present disclosure provided in the Summary.

[0035] FIGS. 6a to 10e show an embodiment according to the present disclosure.

[0036] FIG. 11 shows an alternative embodiment.

[0037] More specifically, in the drawings:

[0038] FIG. 1 Prior art: YpsoPump®;

[0039] FIG. 2 Prior art: Longitudinal cross-section through YpsoPump® with seals;

[0040] FIG. 3 Prior art: Drive unit with a piston rod and a seal;

[0041] FIGS. 4a, 4b, 4c, and 4d Reuleaux triangles and rounded Reuleaux triangles;

[0042] FIGS. 5a, 5b, 5c, and 5d Pentagonal curves of constant width and construction thereof;

[0043] FIG. 6a Isometric view of an infusion pump according, to the present disclosure configured as a modular infusion pump;

[0044] FIG. 6b Pump module of the infusion pump of FIG. 6a, according to the present disclosure;

[0045] FIG. 6c Reservoir module of the infusion pump of FIG. 6a, according to the present disclosure, where the patch is not shown;

[0046] FIG. 7a Pump module of the infusion pump of FIG. 6a, according to the present disclosure, with an extended piston rod, where the cross-section of the piston rod corresponds to a curve of constant width with rounded corners;

[0047] FIG. 7b Front element of the pump module of FIG. 7a, showing an exterior of the front element;

[0048] FIG. 7c Front element of the pump module of FIG. 7a, showing an interior of the front element;

[0049] FIG. 8a Front element of the pump module of FIG. 7a showing an inserted piston rod in a retracted position;

[0050] FIG. 8b Cross-section through the front element and the inserted piston rod in the state of FIG. 8a;

[0051] FIG. 9a Front element of the pump module of FIG. 7a showing the inserted piston rod in an extended position;

[0052] FIG. 9b Cross-section through the front element and the inserted piston rod in the state of FIG. 9a;

[0053] FIG. 10a Front element of the pump module of FIG. 7a with an inserted piston rod with a two-component injection-molded part;

[0054] FIG. 10b showing a hard, pre-molded component of the two-component injection molded part;

[0055] FIG. 10c showing a sealing component of the two-component injection molded part;

[0056] FIG. 10d Cross-section through the front element of FIG. 10a in the area of a reset button;

[0057] FIG. 10e Cross-section through front element of FIG. 10a in the area of the electrical plug connection; and

[0058] FIG. 11 Alternative embodiment of the front element.

DETAILED DESCRIPTION

[0059] The term “product”, “drug” or “medicinal substance” in the present disclosure includes any flowable medicinal formulation suitable for controlled administration by means of a cannula or hollow needle into subcutaneous or intramuscular tissue, for example a liquid, solution, gel or fine suspension containing one or more medicinal active ingredients. A drug may thus be a composition containing a single active ingredient or a premixed or co-formulated composition containing multiple active ingredients from a single container. In particular, the term includes medicaments such as peptides (e.g. insulins, drugs containing insulin, preparations containing and derived from GLP 1 or analogous preparations), proteins and hormones, biologically derived or active ingredients, active ingredients based on hormones or genes, nutritional formulations, enzymes and other substances both in solid (suspended) or liquid form. The term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies, and appropriate base, auxiliary and carrier substances.

[0060] The term “distal” means a side or direction towards the front, insertion end of the delivery device or towards the tip of the injection needle. In contrast, the term “proximal” means a side or direction towards the rear end of the delivery device opposite to the insertion end.

[0061] The terms “delivery device” and “delivery equipment” are used synonymously in this document.

[0062] FIG. 6a shows a delivery device according to the present disclosure in the form of a patch pump 1. The patch pump 1 is similarly constructed as described in the European patent application EP20181599.0, published as EP 3928811 A1, which is hereby incorporated by reference in its entirety.

[0063] Details of the basic technology of the patch pump 1 can be taken directly and unambiguously from the aforementioned published application.

[0064] Patch pump 1 may be of modular configuration, as shown in FIGS. 6b and 6c, and may include a drive module or pump module 2 and a reservoir module 3, which may be detachably connected to each other via a bayonet fitting including a bayonet catch 10 on the reservoir module 3, and a bayonet catch 11 on the pump module 2. When the reservoir module 3 and the pump module 2 are connected to each other via the bayonet fitting, the latching spring 11a of the pump module 2 engages behind the latching lug 10a of the reservoir module 3 so that the modules 2, 3 cannot detach from each other unintentionally. The pump module 2 may be reusable and may include electronics, a drive (e.g., with a motor, a gear, and transmission elements) as well as a piston rod 30 movably mounted therein. Due to its inclusion of the drive, the pump module 2 may also be referred to herein as a drive module. Furthermore, the pump module 2 may include an energy source such as a rechargeable battery.

[0065] The reservoir module 3 may include the reservoir, a power source in the form of, for example, a battery, and an infusion line that may be configured to deliver the drug to be administered from the reservoir to the tissue. When the reservoir module 3 and the pump module 2 are connected, the power source may be used to charge the energy source of the patch pump 2 (e.g., the rechargeable battery or an analogous energy storage device such as a capacitor). The reservoir may generally have the shape of a cartridge with a movable plug supported in the reservoir. By moving the plug in the reservoir, the volume in the reservoir may be increased or decreased. When the pump module 2 and reservoir module 3 are connected, the plug in the reservoir of the reservoir module 3 may be moved by an axial movement of the piston rod 30 of the drive module. For instance, a movement of the piston rod 30 into the reservoir module 3 may cause a reduction of the volume in the reservoir and finally a release of the drug through the infusion line into the tissue of the person using it.

[0066] The piston rod 30 may be movable or slidable, such as partially moved or slid out of the pump module 2. The pump module 2 may include a housing 12 and a face element or front element 20. Various components may be arranged on the front element 20, as shown for example in FIGS. 6b and 7a. These may include but are not limited to a bayonet catch 11 (e.g., a component of the pump module 2, which may be arranged around the aperture 21, which may be nozzle-shaped), an aperture 21 for the piston rod 30, a plug for the electrical connector 23 and a reset button 24. The front element 20 includes a front side 20a and a rear side 20b, see FIGS. 7b and 7c, respectively.

[0067] The piston rod 30 may be guided in the aperture 21, see, e.g., FIGS. 7a to 7c. According to the present disclosure, the piston rod 30 may include a cross-section, which may correspond to the shape of a triangular curve of constant width with rounded corners. The aperture 21 may include a shape, e.g., a complementary shape, which corresponds approximately to the negative of the curve of constant width of the piston rod 30, so that the piston rod 30 can be moved through the aperture 21, but cannot be rotated around the axis of the piston rod 30. The piston rod 30 may therefore be slidably mounted in the aperture 21 so that it can move but is secured against rotation. The aperture 21 may be reinforced by ribs 21a, where the ribs 21a with their end faces 21b may also guide the piston rod 30 (see, e.g., FIGS. 8a to 9b). In order to protect the interior of the pump module 2 from liquids, a seal 22 may be arranged on the front side 20a of the front element 20. A sealing surface 22a of the seal 22 may follow the shape of the curve of constant width of the cross-section of the piston rod 30 (see e.g., FIGS. 8b and 9b) and form a circumferential seal. In the undeformed state, the aperture of the seal 22 may be smaller than the cross-section of the piston rod 30. If the piston rod 30 is pushed through the aperture of the seal 22, the aperture is expanded. Therefore, the seal 22 may be constructed of a deformable material, such as an elastomer. The seal 22 may thus prevent liquid from penetrating the interface between the piston rod 30 and the seal 22 and thus the aperture 21. The seal 22 may be bonded to the bayonet catch 11 of the bayonet fitting portion, for instance at or to the front face 20c of the front element 20. According to the present disclosure, the housing 12 may be constructed of plastic, and the front element 20 may be configured as a two-component injection molded part (e.g., a two-shot injection molded part), which may allow the wall of the front element 20 and the seal 22 to be manufactured as one part with a tight bond, e.g., an adhesive bond. As shown in FIGS. 10b and 10c, the front element 20 may include a component 26, referred to as a face plate 26, and a seal component 25. To facilitate understanding of the front element 20, the front element 20 has been divided into its individual components in FIGS. 10b and 10c. The seal component 25 may be constructed of a softer material (e.g., an elastomeric material) relative to the face plate 26 responsible for guiding the piston rod 30, among other things. For this purpose, the face plate 26 may require a certain rigidity and strength (e.g., a plastic material). During production, the face plate 26 may be injection molded first and then the seal component 25 may be injection molded in the same mold.

[0068] As shown in FIGS. 10c and 10d, the seal component 25 may include not only the seal 22, but also a seal 24 for the reset button. For instance, a reset switch may also be provided in the seal component 25, which may be provided to reset settings in the pump electronics of the pump module 2, for instance, to delete the corresponding memory and/or to restart the electronics of the pump module 2 (e.g., by a short power interruption). FIG. 10d shows a vertical cross-section through the front element 20 in the area of the reset button including the seal 24. The seal 24 may be a structured membrane, for instance where the operating element 24a of the seal 24 does not protrude from the surrounding wall of the front element 20 in the direction of the front 20a, but rather may lie flat or recessed to prevent unintentional actuation of the reset button. In order to hold the seal 24 firmly in the front element 20 (or to improve the adhesion), retaining elements 20d (see FIGS. 10b and 10d) may be arranged on the front element 20 at the transition between the seal 24 and the front element 20 (for instance, a chemical adhesive bond may exist). When the seal 24 is cast onto the face plate 26, this may establish an interlock between the face element 20 and the seal 24.

[0069] Furthermore, the seal component may additionally include a seal 28 for the electrical contacts of the electrical connector 23. In the embodiment shown, the seal 28 may be configured to be undersized compared to the electrical contacts of the electrical connector 23, for instance configured as pins, which may establish a radial contact pressure to seal against such pins or other electrical contacts. This may prevent liquid from penetrating into the interior of the pump module 2 along the electrical contacts. FIG. 10e shows a vertical cross-section through the face element 20 in the region of the electrical connector 23, the right of the figure being the front of the face element 20.

[0070] In implementations, the disclosed seals may be produced separately or together, and when produced together, the seals may be connected to each other via arms 25a, 25b and 25c. Corresponding channels may be provided on a back side of the face plate 26 for producing the adjoined seals. In such implementations, all seals may be molded on via a lug 25d. In this way, the end plate 20 with seals may be elegantly produced in one injection molding process such as a two-shot injection molding process.

[0071] FIG. 11 shows an alternative configuration of the front element 20 of the present disclosure in which a modified front element 20′ may include a modified seal 22′. In the modified seal 22′, the aperture may be configured to be circular and may not be based on the curve of constant width of the piston rod 30. Functional sealing by the seal 22 may nevertheless be possible, precisely due to the shape of the curve of constant width permitting a more homogeneous stress distribution in the seal 22′ so that, for example, in the area of the corners relative to the edges, no excessive stress difference arises, as it may otherwise arise with for example an equilateral triangle as a cross-section for the piston rod. Nevertheless, the shape of the curve of constant width, as described, may provide a non-rotatable piston rod secured against rotation due to the configuration of the delivery devices as provided herein.

REFERENCE LIST

Prior Art:

[0072] p1 YpsoPump® [0073] p2 Cartridges [0074] p3 Septum [0075] p4 Plugs [0076] p5 Housing [0077] p6 Viewing window [0078] p7 Battery cover [0079] p9 Cartridge compartment [0080] p10 (Control) button [0081] p20 Touch display [0082] p30 Infusion set adapter [0083] p30a Cannula [0084] p31 Infusion tube [0085] p40 Motor [0086] p45 Gear [0087] p50 Drive housing [0088] p50a Anti-rotation device [0089] p51 Drive sleeve [0090] p52 Piston rod [0091] p52a Guide groove [0092] p53 Flange [0093] p54 Seal (O-ring) [0094] p60 Bearing plate [0095] p60a Seal [0096] p90 Battery [0097] p91 Battery compartment [0098] p92 Positive battery terminal/connection [0099] p92a Seal [0100] p93 Negative battery terminal/connection [0101] p93a Seal

Curve of Constant Width Figures:

[0102] r1 Reuleaux triangle (simplest non-trivial curve of constant width) [0103] R Width [0104] r2 Equilateral triangle, as a basis for the construction of the Reuleaux triangle [0105] r3 Extended arch for construction curve of constant width with rounded corners [0106] r4 Corner radius (|r4| corresponds to the size of the radius) [0107] R′ Width (R′=R+2*|r4|) [0108] r5 Curve of constant width with rounded corners [0109] r10 Curve of constant width with five corners [0110] r11 Construction pentagon [0111] r12 Circular arc of the pentagonal curve of constant width [0112] R2 Width

Delivery Devices:

[0113] 1 Delivery device in the form of a modular patch pump [0114] 2 (reusable) pump module or drive module [0115] 3 Reservoir module [0116] 10 Bayonet catch (part of reservoir module 3) [0117] 10a Latching lug [0118] 11 Bayonet catch (part of reservoir module 2) [0119] 11a Latching spring [0120] 12 Pump module housing [0121] 20 Front element of the pump module 2, configured as a two-component injection molded part [0122] 20′ Alternative face element [0123] 20a Front side of face element 20 [0124] 20b Rear side of face element 20 [0125] 20c Front face [0126] 20d Retaining elements [0127] 21 Aperture [0128] 21a Ribs [0129] 21b Front faces [0130] 22 Piston rod seal [0131] 22′ Alternative piston rod seal [0132] 22a Sealing surface [0133] 23 Electrical connector element with electrical contacts [0134] 24 Seal reset button (actual reset button not shown) [0135] 24a Operating element [0136] 25 Seal ensemble (sealing component of the face element 20) [0137] 25a Sealing connection to seal 28 for the electrical contacts [0138] 25b Sealing connection to seal 22 for piston rod 30 [0139] 25c Sealing connection to seal 24 for the reset button [0140] 25d Lug [0141] 26 Face plate (load-bearing component of the face element) 20 [0142] 28 Seal for electrical contacts 23 [0143] 30 Piston rod with the cross-sectional shape of a curve of constant width