Patent Grant
9463284
The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2010/068591 filed Dec. 1, 2010, which claims priority to European Patent Application No. 09177682.3 filed on Dec. 2, 2009. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
This invention relates to a dose display mechanism for a drug delivery device that allows a user to select multiple doses of an injectable medicinal product and for the dispensing of a set dose and applying said medicinal product to a patient, preferably by injection. In particular, the invention relates to such devices, which are handled by the patients themselves and which are therefore adapted for self-administration.
Drug delivery devices allowing for multiple dosing of a required dosage of a liquid medicinal product, such as liquid drugs, and further providing administration of the liquid to a patient, are as such well-known in the art. Generally, such devices have substantially the same purpose as that of an ordinary syringe.
Pen-type injectors of this kind have to meet a number of user specific requirements. For instance in case of those with diabetes, many users will be physically infirm and may also have impaired vision. Therefore, these devices need to be robust in construction, yet easy to use, both in terms of the manipulation of the parts and understanding by a user of its operation. Further, the dose setting must be easy and unambiguous and where the device is to be disposable rather than reusable, the device should be inexpensive to manufacture and easy to dispose. In order to meet these requirements, the number of parts and steps required to assemble the device and an overall number of material types the device is made from have to be kept to a minimum.
Document EP 1 642 607 A1 for instance discloses a dose display mechanism consisting of a dose setting dial and a counter ring each displaying indices on their outer circumference arranged such that a two-indices representation of the selected dose can be displayed. The dose setting dial and the counter ring comprise single digits that are visible through a display window of a housing.
The digits are displayed in a readable orientation when the drug delivery device is oriented substantially horizontally. Since most drug delivery devices are designed for right-handed users, the digits are displayed in a correct and upright orientation when from a user's point of view, the distal end section of the device points to the left and when the proximal end section of the device points to the right hand side.
Such a display orientation is particularly applicable, where the user or patient holds the housing of the drug delivery device with his left hand while manipulating the device with his right hand, e.g. for setting and/or dispensing of a dose.
A left-handed user typically utilizes such pen-type injectors in a different way. Left-handed users typically hold the device with their right hand while making use of their left hand for dose setting and dose dispensing. With respect to the fixed display orientation of the dose setting dial, a left-handed user is thus compelled to turn over the device for reading the information illustrated in the display window. Hence, utilization of a standard drug delivery device turns out to be quite cumbersome for a left-handed user. As a consequence, left-handed might be exposed to reading errors or misinterpretation of the displayed information. Finally, the patient might be in danger of dispensing an incorrect dose.
A simple solution to this problem could be achieved by manufacturing of different drug delivery devices that are particularly designed for right- and left-handed users. However, production of drug delivery devices of different type and their configuration implies an increase in manufacturing complexity.
It is therefore an object of the present invention to provide an improved dose display mechanism and a respective drug delivery device that overcome the above-mentioned drawbacks of conventional dose display mechanisms in particular for left-handed users. The present invention therefore aims to provide a dose display mechanism providing unambiguous illustration of dose setting information for both, right-handed and left-handed users. Additionally, the invention focuses on a dose display mechanism that is selectively configurable either for a right-handed or left-handed design of a drug delivery device. Furthermore, the invention aims to simplify construction and assembly of a drug delivery device, in particular of its dose display mechanism.
In a first aspect the present invention provides a dose display mechanism for a drug delivery device that comprises a housing of substantially tubular shape. The housing has at least a first dose displaying window through which dose related information is to be visually displayed. The dose display mechanism further comprises a dose setting dial, preferably of tubular shape, which is rotatably arranged in the housing. The dose setting dial comprises a first and a second dose indicating scale on its peripheral surface. Said dose indicating scales are preferably of helical shape. During a typical dose setting procedure, the dose setting dial is subject to a combined axial and rotational displacement, such that the helically arranged dose-related information is successively illustrated by the fixed displaying window.
The first and the second helical dose indicating scales are particularly adapted to provide an optimized handling of the drug delivery device with respect to right-handed or left-handed usage, respectively. Therefore, the information contents of the first dose indicating scale and the second dose indicating scale are arranged in different orientation, preferably in orientations that are optimized for right-handed use or left-handed use of the dose display mechanism or the drug delivery device.
By providing two dose indicating scales, each of which providing dose-related information in different orientation relative to each other, the dose display mechanism can provide a correct and upright presentation of dose-related information, irrespective on whether the user holds the drug delivery device in a left-handed or right-handed way. Hence, the two dose indicating scales provide a substantially identical information content in a redundant way but in different orientations, each of which being optimized for a right-handed or left-handed user's demands, respectively.
Moreover, by way of providing a first and a second dose indicating scale on a common dose setting dial, the dose display mechanism might become easily configurable or reconfigurable for left-handed or right-handed optimized information content illustration.
Furthermore, the size of the at least first dose displaying window directly matches with the size of the information contents to be displayed by said window. Hence, the dose displaying window provides direct and unaltered visual access to the information contents. The size of the information content and the window size mutually match in order to display the required information in an unequivocal manner. This way, magnifying or other optical display means are generally not required and the housing can be designed in a simple and cost-efficient way. In a preferred approach, the window may comprise a through opening in a side wall section of the housing. Alternatively or additionally, said window may comprise a protective and transparent member covering the information content, wherein the protective member preferably flushes with the outer surface of the housing's side wall section.
In another preferred embodiment, first and second dose indicating scales are axially offset relative to each other. In such configurations, first and second dose indicating scales may be co-aligned in axial direction. Hence, first and second dose indicating scales may be exclusively shifted in axial direction with respect to each other. The first and the second dose indicating scale may present identical information as seen in an axial projection, wherein merely the orientation of digits, numbers or letters of the respective scales differ with respects to each other.
Furthermore, an imaginary line connecting identical information contents of first and second dose indicating scale extends substantially in axial direction as defined by the tubular shape of the housing or the dose setting dial, respectively.
According to a further embodiment of the invention, first and second dose indicating scales are circumferentially offset relative to each other. Hence, an imaginary line connecting identical dose-related information of first and second dose indicating scales extends substantially perpendicular to the axial direction as defined by the tubular shape of the housing or the dose setting dial.
Furthermore and according to another preferred embodiment, it is beneficial, when first and second dose indicating scales are axially and circumferentially offset relative to each other. In such configuration, an imaginary line connecting identical information contents of first and second dose indicating scales extends at an inclination with respect to the axial direction.
In a further preferred embodiment, first and second dose indicating scales present substantially equal information contents. Preferably, each of first and second dose indicating scales comprises a complete set of dose-related information, each of which being entirely informative on the size of a selected dose. This way, first and second dose indicating scales can be regarded as being redundant with respect to each other.
In another beneficial arrangement, the information content of the first dose indicating scale is flipped by approximately 180° relative to the orientation of the information content of the second dose indicating scale. Hence, the first dose indicating scale can be regarded as an upside-down representation of the second dose indicating scale and vice versa. In this way, the first dose indicating scale presents its information content in an upright position when the device is oriented in a typical right-handed fashion. Accordingly, the second dose indicating scale may display its information content in an appropriate and unambiguous way when the drug delivery device is held in a typical left-handed way, e.g. when the drug delivery device is flipped over by 180° compared to its right-handed orientation.
In another preferred aspect, first and second dose indicating scales extent along parallel helices on the common dose setting dial. Hence, first and second dose indication scales comprise the same sense of rotation.
Accordingly, first and second dose indicating scales feature the same graduation of display units, wherein merely the orientation of the respective information representation preferably varies by 180°.
According to a further preferred embodiment of the invention, the display window of the housing comprises first and second adjacently arranged display sections. Hence, the display window is divided into different display sections, which may be located axially next to one another. Here, the first display section overlaps with the first dose indicating scale and the second display section preferably overlaps with the second dose indicating scale. By further providing a cover element adapted to selectively cover the first or the second display section, the dose display mechanism and the entire drug delivery device can be selectively switched to a left-handed or right-handed configuration, simply by arranging the cover element over the first or second display section, respectively.
In another preferred embodiment, the housing comprises an additional, second display window, which is axially and/or circumferentially offset from the first display window. Also here, first and second display windows substantially overlap with first and second dose indicating scales of the dose setting dial, respectively. Having two display windows, the dose display mechanism is generally adapted to simultaneously provide redundant dose-related information, which is correctly illustrated in a right-handed as well as in a left-handed orientation of the drug delivery device, respectively.
Depending on axial and circumferential offset of first and second dose indicating scales, also the respective display windows are arranged with a respective axial and/or circumferential offset relative to each other. It is further conceivable, that first and second display windows substantially overlap in an axial or circumferential projection, wherein an imaginary line connecting first and second display windows extents substantially in axial direction or perpendicular thereto.
However, if first and second dose indicating scales are axially and circumferentially offset relative to each other, this will also apply to the respective first and second display windows.
In a further preferable embodiment, first and second display windows are offset in circumferential direction relative to each other by substantially 180°. Hence, first and second display windows are diametrically opposed to each other in the tubular shaped housing's sidewall.
According to another independent aspect, the invention also relates to a drive mechanism for a drug delivery device that comprises a dose display mechanism according to the present invention.
Also, the present invention refers to a respective drug delivery device for dispensing of a pre-defined dose of a medicinal product and which further comprises the present dose display mechanism.
Furthermore, and according to another preferred embodiment, the drug delivery device comprises a cartridge filled with the medicinal product. The device may be of reusable and/or disposable type. Preferably, the device is to be commercially distributed with a filled cartridge readily disposed therein.
The term “medicament” or “medicinal product”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound,
wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a protein, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound,
wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis,
wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy,
wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4.
Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.
Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
Exendin-4 derivatives are for example selected from the following list of compounds:
Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in “Remington's Pharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology.
Pharmaceutically acceptable solvates are for example hydrates.
It will be apparent to those skilled in the pertinent art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Further, it is to be noted, that any reference signs used in the appended claims are not to be construed as limiting the scope of the present invention.
Without limitation, the present invention will be explained in greater detail below in connection with preferred embodiments and with reference to the drawings in which:
The displaying windows 12, 14 may comprise any suitable opening in the housing. In a rather simple embodiment, the windows 12, 14 merely comprise a hole or a through opening in the housing. In other embodiments, the displaying windows 12, 14 may comprise a transparent cover that allows to visualize and to display the actual device configuration. Typically, the displaying windows 12, 14 are adapted to provide dose-related information by displaying numerical and/or graphical symbols, such as digits, numbers or other suitable characters.
Inside the housing 10, there is arranged a tubular shaped dose setting dial 16, which is exemplary illustrated in
As can be seen from
The two dose indicating scales 18, 19 are readable from different device orientations, respectively. For reading the first dose indicating scale 18, the dose setting dial 16 or the respective drug delivery device should be kept in an upright orientation. For reading of the second dose indicating scale 19, the dose setting dial has to be rotated by 180°. Hence, the device has to be held upside-down, which for the given type of device is typical for a left-handed user.
Orientation of the information content, hence the presentation of the respective numbers or symbols of each dose indicating scale differs by substantially 180°. The axial and circumferential offset of first and second dose indicating scales 18, 19 corresponds to the respective axial and circumferential offset of first and second displaying windows 12, 14 of the housing 10. In this way, the illustrated dose display mechanism 10 is adapted to show identical dose-related information in both windows 12, 14 simultaneously in different, typically flipped orientations. In this way, the display mechanism and a respectively equipped drug delivery device is universally applicable for both, right-handed and left-handed users.
As further illustrated in
As further illustrated, an imaginary connection line 28 connecting identical digits 24, 26 of first and second dose indicating scales 18, 19 extends at an inclination with respect to the longitudinal axes 20 as well as with respect to the circumferential direction 22.
In the embodiment according to
The cover element 37 may either permanently or re-configurably attached to the respective display sections 33, 34. In this way, a respective dose display mechanism can be configured or even re-configured for the purpose of right-handed or left-handed usage.
Since first and second display sections 33, 34 of the display window 32 substantially overlap in circumferential projection but are located axially next to one another, the dose setting dial 36 as shown in
In contrast to the dose setting dial 16 of
Also here, the dose setting dial 36 comprises a helical thread 35 optionally providing a threaded engagement of housing 30 and dose setting dial 36. By means of such a screw structure, the dose setting dial is allowed to rotatably move towards a proximal end of the drug delivery device during dose setting.
In a third embodiment according to
Comparable to the dose setting dials 16, 36 also the dose setting dial 56 comprises a helical thread 55 indicating the helical-like motion of the dial 56 relative to the housing 50 during a dose setting procedure. Since the first and second displaying windows 52, 54 are merely circumferentially offset with respect to each other, the same applies to the corresponding dose indicating scales 58, 59. In the illustration of
Generally, the dose setting dial may be releasably connected to a not further illustrated drive mechanism of a drug delivery device, typically by some clutch means. For setting of the dose, the dose setting dial may be rotated together with an inner cylinder or a comparable component of the drive mechanism. Typically, during dose dispensing, the clutch means may disengage the dose setting dial from the drive mechanism. Further, the dose setting dial may comprise one or more stops to limit the maximum amount of a single dose.
| Number | Date | Country | Kind |
|---|---|---|---|
| 09177682 | Dec 2009 | EP | regional |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2010/068591 | 12/1/2010 | WO | 00 | 9/24/2012 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2011/067267 | 6/9/2011 | WO | A |
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