This application claims priority to European Patent Application No. 21204488.7 filed Oct. 25, 2021, entitled “IMPROVED DELIVERY DEVICE”, which is incorporated herein by reference in its entirety and for all purposes.
The present disclosure relates to the field of delivery devices and delivery devices for delivering fluid drugs, such as infusion or injection devices, and provides delivery devices with movable piston rods.
A variety of delivery devices for administering fluid, especially liquid drugs, are known. These range from simple disposable syringes to injection pens and infusion devices with sophisticated functions. In the case of reusable delivery devices, to maintain the longevity of these devices it is important to protect key device components such as the drive or electronics from exposure to moisture, e.g., from penetrating liquid.
The problem is explained herein, using insulin pumps as an example. However, the problem also occurs with reusable injection pens and other delivery devices, which is why the following explanations should not be interpreted as restrictive.
For example, the applicant's YpsoPump® is known from the prior art. The YpsoPump® is a conventional insulin pump with which insulin can be administered from a standard cartridge.
The infusion set adapter p30 holds the cartridge p2 in the infusion pump p1 and is fixed in the YpsoPump® p1 via a bayonet catch. However, the infusion set adapter does not provide a watertight seal to the cartridge compartment p9.
In order to protect sensitive areas of the YpsoPump® p1, such as the electronics p80 or motor p40, from the ingress of liquids, various sealing elements, in particular O-rings p54 and p60, are arranged in the YpsoPump® p1, which protect the drive side/cartridge compartment. O-rings p92a and p93 also provide protection on the battery compartment side. The sliding engagement between piston rod p52 and anti-rotation device p50a is also not liquid-tight, for instance at the closed end p50b, so that the area between piston rod p52 and drive sleeve p51 could become contaminated—a potential for further improvement.
As shown in
Alternatively, piston rods with an angular cross-section (square, rectangle) are known to achieve an anti-rotation of the piston rod. But even with these classic shapes, a sealing problem arises because the contact pressure of a seal arranged around the cross-section reaches a maximum in the corners and is weaker along the edges, so that the risk of leaks is considerable.
Disclosed are delivery devices operated with conventional piston rods, which provide improved protection of device components from exposure to liquids.
Implementations relate to fluid drug delivery devices as defined herein for delivery of drugs or products. The delivery devices may be injection devices, for example injection pens, or infusion devices. In the case of infusion devices, these may include insulin pumps and patch pumps; and in the case of injection devices, these may include auto-injectors, pens for the automatic and repeated delivery of individually adjustable doses (so-called autopens) and patch injectors. The delivery devices may be of monolithic or modular configurations. Common to all devices, according to the present disclosure, is that there are areas of the delivery device that are to be protected from liquids. These may be mechanical, electrical, electronic, magnetic, or electromagnetic components, assemblies or combinations thereof.
A delivery device, according to the present disclosure, may include a housing, which in turn may, but need not, include several modules. The modules may be smaller housings in themselves.
In the housing of the delivery device, a reservoir may be located at least partially inside the housing. For example, a distal end of the reservoir through which the drug is delivered may be located outside the housing. The reservoir may include an internal volume, which is able to be reduced for dispensing the drug.
The reservoir may be a so-called cartridge in the broader sense, including a dispensing or shot end with a septum, the septum being pierceable by means of a cannula. For example, the cannula may be a hypodermic needle, or the cannula of an infusion set adapter. At its opposite end, the cartridge may be configured to be open, with a movable stopper or plug closing the open end. Thus, an internal volume is formed in the cartridge, and this volume may be increased or decreased by moving the stopper. Various cartridge materials are known to the skilled person, and may be constructed of glass or plastic, with a round or oval cross-section, or with a linear axis or a curved axis (e.g., toroidal).
Alternatively, the reservoir may be a bag that is squeezed when the drug is delivered.
The delivery device, according to the present disclosure, may further include a drive device. The drive device may be at least partially arranged in the housing or a module of the housing. The drive device may serve to expel the drug from the reservoir when the reservoir is present. The drive device may include a drive. The drive may serve as a source of mechanical energy. The drive may be a motor, such as an electric motor. Alternatively, and for instance when the delivery device is an injection device, the drive may be an arrangement of one or more springs. The function of the drive is to move a piston rod, which is also at least partially movably mounted in the housing or partially movably mounted in one or more modules. According to the present disclosure, the piston rod may be displaceably but non-rotatably mounted directly or indirectly in the housing or a module thereof. The drive may be directly or indirectly coupled to the piston rod. For instance, if the drive is a motor, a gear may be arranged between the drive and the piston rod, which may convert the motor movement (usually a rotating, driven axis) into a sliding movement of the piston rod. The coupling between the drive (direct or indirect) and the piston rod may, for example, occur via a threaded coupling between the drive and the piston rod. For example, the piston rod may have an internal thread in a threaded engagement with a threaded rod or spindle of the drive. Rotation of the threaded rod or spindle may cause or evoke displacement of the piston rod due to the non-rotating nature of the piston rod. The threaded rod or spindle may thus be the output element of a gear between a motor and the piston rod.
The piston rod may, for example, move a cartridge stopper or compress a bag during its displacement movement.
As described, the piston rod may be mounted movably, but rotation about its own axis relative to the housing or the module (e.g., housing module) in which the piston rod is mounted may not be permitted or even possible. According to the present disclosure, an aperture may be provided in an inner wall of the housing or a wall of a module of the housing, on or in which one or more anti-rotation elements are present. The piston rod may be guided through this aperture and mounted therein so that it is movable or slidably mounted. The aperture may be a polygonal aperture or passage through which the piston rod is guided, and the polygonal shape may approximately correspond to the cross-section of the piston rod. In this way, an anti-rotation feature may be provided in a manner similar to that described previously. In addition or alternatively, rotation of the piston rod may be prevented by providing additional elements or structures fixed to the aperture. The wall may also be mechanically reinforced in the area of the aperture to absorb additional forces acting on the wall. For instance increasing the wall thickness, providing rib-like reinforcements, or other means known to the skilled person may be used to provide anti-rotation features and/or structural reinforcement.
The aperture may further be provided with a seal according to the present disclosure, which may function to seal the area between the aperture and the piston rod, such that when the piston rod is passed through the aperture, no liquid can pass from one side of the wall to the other through the aperture. For instance, a bearing surface between the piston rod and the aperture may include the seal configured to prevent liquid from passing through the aperture, while permitting displacement of the piston rod. The seal may be formed with a material that is at least elastically deformable, and may function to seal the periphery of the piston rod at least via direct contact or by conforming to the piston rod, e.g., by forming a circumferential seal. For instance, the contact between the seal and the piston rod may not only be linear, but may also extend along the axis of the piston rod so that a circumferential seal is formed. The displaceability of the piston rod may be maintained and may for instance be movable bi-directionally or in multiple directions based on the operation of the delivery device.
According to the present disclosure, the piston rod may have a cross-sectional shape, at least over the axial area that is displaced through the aperture, adapted to facilitate providing an improved seal. The shape of the cross-section may correspond to a non-trivial “orbiform curve”. To illustrate what a curve of constant width is (also referred to as a curve of uniform thickness or equal thickness), the comprehensible definition from Wikipedia is reproduced here:
“In geometry, a curve of constant width is a simple closed curve in the plane whose width (the distance between parallel supporting lines) is the same in all directions. The shape bounded by a curve of constant width is a body of constant width or an orbiform . . . . These curves can also be constructed using circular arcs centered at crossings of an arrangement of lines, as the involutes of certain curves, or by intersecting circles centered on a partial curve.
Every body of constant width is a convex set, its boundary crossed at most twice: by any line, and if the line crosses perpendicularly it does so at both crossings, separated by the width. By Barbier's theorem, the body's perimeter is exactly π times its width, but its area depends on its shape, with the Reuleaux triangle having the smallest possible area for its width and the circle the largest. Every superset of a body of constant width includes pairs of points that are farther apart than the width, and every curve of constant width includes at least six points of extreme curvature. Although the Reuleaux triangle is not smooth, curves of constant width can always be approximated arbitrarily closely by smooth curves of the same constant width.
Cylinders with constant-width cross-section can be used as rollers to support a level surface. Another application of curves of constant width is for coinage shapes, where regular Reuleaux polygons are a common choice. The possibility that curves other than circles can have constant width makes it more complicated to check the roundness of an object.
Curves of constant width have been generalized in several ways to higher dimensions and to non-Euclidean geometry.”
The simplest, nota bene trivial curve of constant width is the circle. The simplest non-trivial curve of constant width, which represents a cross-sectional shape according to the present disclosure, is the so-called Reuleaux triangle or arc triangle r1, as shown in
Between the Reuleaux triangle and the circle, there are an infinite number of other curves of constant width; what they have in common with the Reuleaux triangle is the odd number of corners and the convex shape between the corners. For instance, the curve of constant width may include three or more corners such as five corners or seven corners. As a further example, the pentagonal curve of constant width and its construction are shown in
Curves of constant width are not required to be equilateral like the Reuleaux triangle. The construction simply follows certain mathematical rules. The convex curved sides are central in the sealing of the aperture, whereby more regular pressure distributions in the seal (or surface pressure acting on the piston rod) can be accomplished. Nevertheless, such cross-sectional shapes make it possible to achieve anti-rotation.
In aspects of the present disclosure, the area of the wall that includes the aperture may be configured as a two-component injection-molded part, where the supporting component, e.g., the actual wall, may be injection molded from a first material (e.g., a first component, which may be referred to as a pre-molded part such as plastic, for instance a rigid thermoplastic polymer) and the seal component may be injection molded from a second material, which may be at least elastically deformable (e.g., a second component) for instance relative to the first material. On the one hand, this approach makes it possible to provide an area of the wall in one operation with a suitable seal. On the other hand, the area of the wall may contain further apertures, which may also be sealed in the same operation. These can for instance be seals for operating elements (buttons) or seals for electrical feed-throughs.
In some aspects, the material for the second component may be injection-moldable, such as a thermoplastic polymer, such as thermoplastic polyurethane or thermoplastic polyamide. The thermoplastic polymer may also be a thermoplastic elastomer. In a further alternative, the second component may include silicone, for example a two-part silicone, which cures in the injection molding device.
In aspects of the present disclosure, the delivery device may be an infusion pump in the style of the YpsoPump® as described herein. Alternatively, the infusion pump may be a modular pump including, for example, a reusable module with electronics and drive as well as a disposable module. The disposable module may then contain, for example, the drug reservoir and, for instance, an energy source. The infusion pump may be a so-called patch pump, which may be adhered to the skin of the person using it, and may be configured as a modular patch pump.
In aspects, the delivery device may be an injection device. For instance, the injection device may be pen- or pencil-shaped. Alternatively, the injection device may be a so-called patch injector, which may be adhered to the skin of the user for a single injection of a drug. In a further alternative, the injection device may be a pen-shaped auto-injector, such as that marketed by the applicant as Ypsomate™. In yet another alternative, the injection device may be an injection pen configured to automatically dispense multiple doses, such as the applicant's well-known ServoPen®. The injection devices may, for example, contain electronics that require protection.
Implementations are described in connection with the appended figures, which are exemplary and are in no way to be interpreted as limiting.
More specifically, in the drawings:
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.
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.
The terms “delivery device” and “delivery equipment” are used synonymously in this document.
Details of the basic technology of the patch pump 1 can be taken directly and unambiguously from the aforementioned published application.
Patch pump 1 may be of modular configuration, as shown in
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.
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
The piston rod 30 may be guided in the aperture 21, see, e.g.,
As shown in
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.
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.
Number | Date | Country | Kind |
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21204488.7 | Oct 2021 | EP | regional |