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    • 专利摘要:
    set of encoded cartridges. the present invention relates to cartridge assemblies (300) which include coding elements (318) which help to dedicate a reservoir of medication to specific injection devices. a set of exemplary cartridges (300) comprises an inner cylindrical surface for containing the medicament and an outer cylindrical surface comprising at its proximal end one or more retainers configured as coding elements (318) projecting from the outer cylindrical surface. each coding element (318) is configured to couple only one corresponding coding component (330) to a dose setting and application mechanism (302), allowing only the correct cartridge set (300) to connect to the dose adjustment and application (302).
    公开号:BR112012027109B1
    申请号:R112012027109-1
    申请日:2011-04-21
    公开日:2020-06-02
    发明作者:Richard James Vincent Avery
    申请人:Sanofi-Aventis Deutschland Gmbh；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for CODED CARTRIDGE SET.
    PATENT APPLICATION FIELD [001] The present invention relates generally to medical application devices which comprise a set of cartridges and a dose adjustment member, in particular to the sets of cartridges that have coding elements, for example , retaining elements, which couple with complementary coding elements, for example, the retaining elements, on the dose adjustment member to ensure that the appropriate cartridge set is connected to the appropriate dose adjustment member.
    BACKGROUND [002] Medicine reservoirs such as ampoules, cartridges or vials are generally known. Such reservoirs are especially used for medications that can be self-administered by a patient. For example, with regard to insulin, a patient suffering from diabetes may require that a certain amount of insulin be injected through a pen-type injection syringe or infused through a pump. With respect to certain reusable pen-type drug delivery devices, a patient carries a cartridge containing insulin in a cartridge holder. The cartridge plus the holder are a type of cartridge set. After the cartridge has been loaded correctly, the user may then have to select a dose of the drug. Multiple doses can be dosed from the cartridge. Once the cartridge is empty, the cartridge must be removed and replaced with a new one. Most suppliers of such cartridges recommend that the user dispose of empty cartridges correctly.
    [003] Such well-known self-management systems that require
    Petition 870190097706, of 09/30/2019, p. 8/51
    2/36 removing and refilling empty cartridges has certain limitations. For example, in certain generally known systems, a user simply loads a new cartridge into the delivery system without the drug delivery device or the cartridge that has any mechanism for preventing the incorrect use of an incorrect cartridge. That is, the drug delivery device has no mechanism for determining whether the drug contained in the cartridge is certainly the correct type of drug to be administered by the patient. Alternatively, the drug delivery device does not have a mechanism for determining whether the correct type of drug in the cartridge is used with that particular drug delivery system. This potential problem can be exacerbated due to the fact that certain older patients, such as those suffering from diabetes, may have limited manual dexterity. The identification of an incorrect medication is very important, since administering a potentially incorrect dose of a medication such as a short-acting insulin in place of a long-acting insulin can result in injury or even death.
    [004] Some drug delivery devices or systems may use a color coding scheme to assist a user or nurse in selecting the correct cartridge to be used with a correct drug delivery device. However, such color coding schemes pose challenges for certain users, especially users who suffer from poor vision or color blindness: a situation that may be completely prevalent in patients suffering from diabetes.
    [005] Another issue that may arise with replaceable disposable cartridges is that these cartridges are manufactured in essentially standard sizes and must satisfy certain
    Petition 870190097706, of 09/30/2019, p. 9/51
    3/36 recognized local and international standards. Therefore, such cartridges are typically supplied in standard size cartridges (for example, 3 ml cartridges). Therefore, there may be a variety of cartridges that are supplied by a number of different suppliers and contain different drugs but that can fit a single drug delivery device. As an example only, a first cartridge containing a first drug from a first supplier may fit a medical application device provided by a second supplier. In this way, a user may be able to load and then apply an incorrect medication (such as a type of fast or basal insulin) to a drug delivery device without being aware that the medical delivery device may not have been designed or intended for use with such a cartridge and therefore the medicine contained within that cartridge.
    [006] In this way, there is a growing desire for users, healthcare providers, nurses, regulators, and medical equipment providers to reduce the potential risk for a user to load an incorrect type of drug on a device. drug application. Therefore, there is also a desire to reduce the risk of applying an incorrect drug (or the wrong drug concentration) to such a drug delivery device.
    [007] There is, therefore, a general need to physically dedicate or mechanically code the fasteners that allow cartridge assemblies, whether they be a cartridge holder or a molded cartridge without a separate holder, to be attached to the adjustment portion of dose of an injection device. In this way, a particular type or types of drugs are linked to the appropriate injection device (for example, dose adjustment member). Similarly, there is also a general need for a dedicated cartridge
    Petition 870190097706, of 09/30/2019, p. 10/51
    4/36 that allows the medical application device to be used with only an authorized cartridge that contains a specific medication and prevents unwanted cross-use of the cartridge. There is also a general need for the provision of a dedicated fixing element in the cartridge assembly that is difficult to tamper with so that the cartridge assembly cannot be compromised, since the drug can be used with a drug or a device. unauthorized drug application. Due to the fact that such sets of cartridges can be difficult to tamper with, they can also reduce the risk of counterfeiting, that is, making it more difficult for counterfeiters to supply unregulated forged products.
    [008] An objective is to provide an improved coded cartridge set to be attached to a dose adjustment member of an injection device.
    SUMMARY [009] This objective can be achieved by a set of cartridges that is configured to be connected to a dose adjustment and application mechanism, in which the set of cartridges comprises a cylindrical body to contain a medication reservoir, in which the cylindrical body has a proximal end that has an outer surface and an inner surface. A retainer is provided on the outer surface or on the inner surface of the proximal end portion, the retainer being suitable for securing the cartridge assembly to the drug delivery adjustment mechanism. The cartridge assembly also comprises at least one coding element that is separate from the retainer. In one embodiment, the coding element is encoded so as to couple with a corresponding coding element in the dose adjustment and application mechanism, thereby allowing the set of cartridges to be operatively connected to the dose adjustment and application mechanism. . The he
    Petition 870190097706, of 09/30/2019, p. 11/51
    5/36 encoding ensures that the set of cartridges can be attached to the corresponding dose adjustment and application mechanism so that the device is operable.
    [0010] If a user attempts to attach the cartridge set to another dose adjustment device, the code elements must prevent the attachment.
    [0011] Here are presented sets of cartridges that include coding elements that help to dedicate a reservoir of medicine to specific injection devices. A set of exemplary cartridges comprises a cylindrical inner surface for containing the medication and a cylindrical outer surface comprising its proximal end in one or more retainers configured as coding elements that protrude from the cylindrical outer surface. Each coding element is configured to couple only with a corresponding coding element in a dose adjustment and application mechanism, thus allowing only the correct cartridge set to connect to the dose adjustment and application mechanism.
    [0012] An injection device can be a drug delivery device designed to deliver a selected dose of a drug, for example, insulin, insulin analogs, growth hormones, heparins and their derivatives, etc., optionally suitable for self-administration. The dose can be fixed or variable. The device may be of the mechanical type or may comprise electronic elements. The device may be a mobile, manual device, for example, a pen-type drug delivery device. The device can be disposable or reusable. The device comprises a dose adjustment and application mechanism, shortened by a dose adjustment member, which allows to adjust and apply a dose.
    [0013] A set of cartridges can be formed as a su
    Petition 870190097706, of 09/30/2019, p. 12/51
    6/36 cartridge size suitable for containing a cartridge or as a molded cartridge without a separate holder. The retainer is suitable for connecting the cartridge assembly to the dose adjustment and delivery mechanism. The retainer can be selected from the group consisting of threads, pins and grooves, pins and ribs, bayonet, pressure fitting, and retainers. A cylindrical body can be a tubular body that can have an essentially circular cross section. The shape of the cross section is not limited to a circle.
    [0014] The coding elements can be located on the outer surface, on the inner surface, or at an axial end of the cylindrical body. The coding element can be any indentation or protuberance, in any direction, of any size and / or of any shape, of a cartridge holder or dose adjustment member. The coding element and the corresponding coding element are combined in such a way that the set of cartridges can be operatively connected to the dose adjustment and application mechanism, when the coding element and the corresponding coding element are coupled, which it can mean locking the coding element and the corresponding coding element. In other words, if the dose adjustment and application mechanism does not comprise corresponding coding elements, the cartridge assembly cannot be attached to the dose adjustment and application mechanism so that they fit together precisely and so that the injection device operates. The coding element can be formed as a retaining element and the corresponding coding element can be formed as a counter-retaining element. The retaining element and the counter-retaining element are suitable for locking or making contact in this way, blocking the stroke in the connection process and allowing the cartridge assembly to connect operatively to the adjustment mechanism.
    Petition 870190097706, of 09/30/2019, p. 13/51
    7/36 te and dose application. The movement of the cartridge assembly during fixing can be stopped when the retainer element touches the counter-retaining element. This allows the set of cartridges to be fixed to the dose adjustment and application mechanism so that the injection device is operable. The retaining element can be configured to contact the counter-retaining element in an axial, helical or circumferential direction. In one embodiment, the retaining element is configured to contact the counter-retaining element in the direction that is normal to the direction of travel of the cartridge assembly at the time of contact.
    [0015] The cartridge set can be coded to a dose adjustment member by using retaining elements located at the proximal end of the cartridge set to ensure that an injection device user does not misuse the medication incorrect. In one aspect, a set of cartridges is presented, described as a cartridge in a holder or a molded cartridge without a separate holder, to contain a medicine reservoir, which has a retainer at the proximal end (that is, the end that is fixed to a dose adjustment device), which includes one or more coding elements combined with a retainer located at the distal end of a dose adjustment device. The retention / coding elements operatively connect the set of cartridges to the retention / coding elements on the dose adjustment device, thereby allowing the user to administer an injection of the desired medication.
    [0016] The integral coding / retaining elements may comprise combinations, such as a pin and a rib, a pin and a pin, a rib and a pair of pins, a pin and a groove, and a screw thread. The use of plugs to lock the cartouche assembly
    Petition 870190097706, of 09/30/2019, p. 14/51
    8/36 chos in the dose adjustment member is also advantageous. The cartridge assembly comprises a tubular member that has a cylindrical inner surface and a cylindrical outer surface that has a retainer on either surface that comprises a first coding element that is coded to couple a second coding element to a complementary retainer in a dose adjustment member, thereby allowing the cartridge assembly to operatively connect to the dose adjustment member. The coding elements integral with the cartridge assembly, the retainer and the complementary retainer in the dose adjustment assembly can be any combination of pins, ribs, rib, grooves, notches, protuberances, valleys and similar structures, as long as the elements of coding to be combined and allow two sets to be connected operatively, that is, as a key in a lock or pieces in a puzzle.
    [0017] In a possible exemplary embodiment, the set of cartridges to contain a medicine reservoir, the set comprises a cylindrical body to contain the medicine reservoir, where the cylindrical body has a proximal external surface positioned between a shoulder and an axial end proximal which also has a retainer on the proximal outer surface. There is at least one retainer on the proximal outer surface that is coded to mate with a corresponding coding retaining element on a dose adjustment member, thereby allowing the assembly to operatively connect to the dose adjustment member. In a preferred configuration, the retainer is a pin that abuts a proximal surface of the shoulder that can be positioned on the outer surface of the proximal end. This retainer can be a radial pin or an axial pin. Likewise, there may be a plurality of detents displaced from each other and / or different in size in the ex
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    9/36 axial, circumferential or radial tension with each other. More preferably, the retainer is separated from the retainer.
    [0018] In yet another configuration, the retainer is a cutout and the corresponding coding retaining element located on the dose adjustment member is a pin.
    [0019] In one embodiment, the set of cartridges is configured to be rotated until the pin contacts a counter-retaining face of a groove element that is an axial cutout in a circular rib of the dose adjustment mechanism.
    [0020] A medication delivery device may comprise a dose adjusting member and a set of cartridges to contain a medication reservoir, wherein the set comprises a cylindrical body to contain the medicament reservoir, wherein the cylindrical body has a proximal outer surface positioned between a shoulder and a proximal axial end. There is a retainer on the proximal outer surface that has a connection direction and at least one retainer on the proximal outer surface that is coded to mate with a corresponding coding element on the dose adjustment member, where the dose member allows the assembly connect operatively to the dose adjustment member.
    [0021] The corresponding coding element in the dose adjustment member is a counter-retainer and the coupling is on a face that is in the radial plane of the counter-retainer. Alternatively, the corresponding coding element in the dose adjustment member is a counter-retainer and the coupling with the retainer is on a face that is in the longitudinal plane. The direction of contact between the corresponding retaining elements should preferably be normal to the connection direction of the retainer. In addition, the corresponding coding element can be a cutout configured to receive the retainer
    Petition 870190097706, of 09/30/2019, p. 16/51
    10/36 when the dose adjustment member and cartridge assembly are operatively connected.
    [0022] Coding can be done by varying the coding elements in a number of ways including, but not limited to, the following:
    i. Number of elements.
    ii. Position of the elements - axial / circumferential / radial, especially in relation to a standard element, for example, the axial length of an end or of a fixing means.
    iii. Size of the elements, for example, the axial / circumferential / radial extension. The size of each element can be different from at least one of the others, for example a number of coding pins with different radial extensions.
    iv. Cross-sectional shape of the elements in any plane, for example, longitudinal, transversal or normal to a propeller, but preferably in a plane normal to the fastening action.
    [0023] The angle of the coding faces on the cartridge set and on the complementary coding element on the dose adjustment member and the way in which they come into contact can be in any direction. For example, the contact can be in the axial / helical / circumferential direction, although it is preferably in the direction of the fastening action. The coding elements can be pins or can cover a significant proportion of the outside of the cartridge assembly.
    [0024] If the cartridge set fits in only one orientation, the number of coding combinations is increased. This can be achieved if one or more coding elements (or an additional element) have an asymmetric position or size around the axis, or if one of the elements is singular, for example, a cutout that is smaller than all the others . Alternatively, the
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    11/36 coding can be included more than once, offering redundancy in the event that a coding set is damaged, and also allowing the user to insert the cartridge set in more than one orientation.
    [0025] Coding may depend on more than one coding element. A coding system can consist of a number of elements, one of which blocks the course in the clamping action much earlier than all of the remaining elements, and one of which blocks the course later than all of the remaining elements. With only one element, a coding element that blocks the course in the action of fixing well before will fit into a device where the course must be blocked later. By combining two elements, all drugs can be prevented from fitting into the wrong devices.
    [0026] In one embodiment, a first and a second set of cartridges are provided in which the first set of cartridges contains a first drug and the second set of cartridges contains a second drug different from the first drug. The coding element of the first set of cartridges is unique to the first drug and is specifically coded to couple only with a corresponding coding element in a dose adjustment and delivery mechanism that is configured to deliver the first drug and in which the second set of cartridges does not connect operatively with the first dose adjustment and application mechanism.
    [0027] The coding element of the second set of cartridges can be unique for the second medicine and is specifically coded to couple only with a corresponding coding element in a dose adjustment and application mechanism that is configured to apply the second medicine.
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    12/36 [0028] A third set of cartridges that contains a third drug other than the first and second drugs can be provided, where the coding element of the third set of cartridges is unique to the third drug and where the third set of cartridges connects operatively only with a third dose adjustment and application mechanism that is different from other dose adjustment and application mechanisms. The first and second cartridge sets are a collection of cartridge devices, where the coding elements prevent the cartridge sets from being attached to the incorrect dose adjustment and application mechanisms.
    [0029] In one embodiment, the cartridge sets have the same type of retainers, and in which the coding element of the first set is different from the coding element of the second set. In this way, cartridge assembly manipulations are similar, but none of the cartridge sets in the system can be attached to incorrect devices.
    [0030] A collection of cartridge sets in which each has encoded retaining elements to allow connection of different drug reservoirs to specific combined dose adjustment members to make up a family of injection devices. For example, the collection may have two or more sets of cartridges, wherein a first set of cartridges comprises (a) a tubular member that has a cylindrical inner surface and a cylindrical outer surface at a proximal end, (b) a first drug within the tubular member, (c) a retainer on the cylindrical outer or inner surface of the tubular member, and (d) an encoded retainer separate from the retainer located at the proximal end of the tubular member comprising a first coding element that is unique to the first medicine and is coded specifies
    Petition 870190097706, of 09/30/2019, p. 19/51
    13/36 for coupling only with a corresponding coding retaining element on a dose adjustment member on a first dose adjustment member that is configured to apply the first drug. The first coding element is different from a second coding element in a retainer encoded in a second set of cartridges in the collection containing a second drug, in which the first and second drugs are different and in which the second set of cartridges is not it will operatively connect to the first dose adjustment member, thereby preventing the first dose adjustment member from administering the second drug.
    [0031] In addition, the collection may also comprise a third set of cartridges that have an encoded retainer that comprises a third unique encoding element for a third drug contained in the third set of cartridges that is different from the first and second drugs and in which the third set of cartridges operatively connects only with a third dose adjustment member that is different from the other dose adjustment members in the injection device family. All encoded retainers of the cartridge sets in the collection can also have the same type of fastener selected from the group consisting of threads, pins and grooves, pins and ribs, bayonet, pressure fitting, and plugs, and in which each element coding associated with each coded retainer is different from all the remaining encoding elements in the other encoded retainers in the cartridge sets in the collection.
    [0032] In a system in which the helical course is followed by the rotational course, the coding elements can prevent the course for the rotational phase if the drug is incorrect. This will make it obvious to the user that the drug is incorrect. The fixing action may stop due to
    Petition 870190097706, of 09/30/2019, p. 20/51
    14/36 to the elements within the fastening means, for example, when the pin reaches the end of the groove. Alternatively, the coding elements can provide the unique retain. If the coding elements come from the retainer, the set of cartridges may override if the wrong drug is inserted. It can then be ejected along a groove, which can have a one-way element to prevent entry into the groove during normal fixation. Although the preferred embodiments are illustrated with the fixing means as a pin in the device that follows a groove in the cartridge assembly, and the stroke is then axial, then helical and then rotational, the coding can be used with any fixing means and any combination of directions in the stroke, including the purely axial stroke.
    [0033] Coding can block all wrong or only the most dangerous drugs, for example, a short-acting drug can be fitted into a device for long-acting drugs, or a low-concentration drug in a device for high concentration , but not vice versa. The coding elements can be detected by electromechanical means, for example, micro switches, or optical / magnetic switches. A programmable pen can then respond to the type of drug, for example, by limiting the maximum dose.
    [0034] These, as well as other advantages of various aspects, will become apparent to the elements versed in the technique by reading the detailed description below, with appropriate reference to the attached drawings.
    [0035] The terms drug or medicine, as used herein, preferably mean a pharmaceutical formulation containing at least one pharmaceutically active compound, [0036] in which in one embodiment the pharmaceutically active compound has a molecular weight of up to 1,500 Da and / or is a peptide,
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    15/36 a protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody, hormone or oligonucleotide, or a mixture of the aforementioned pharmaceutically active compound, [0037] in which in an additional embodiment 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 (CHA) , angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis, [0038] in which in an additional 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, [0039] in which in an additional embodiment the compound fa pharmaceutically active 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. [0040] 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, where proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and where at position B29 Lys can be replaced by Pro; Ala (B26) human insulin; Des (B28-B30) human insulin Des (B27) human insulin and Des (B30) human insulin.
    [0041] Insulin derivatives are, for example, B29-N-myristoildes (B30) human insulin; B29-N-palmitoyl-des (B30) human insulin; Human B29-N-myristoyl insulin; Human B29-N-palmitoyl insulin;
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    16/36
    B28-N-myristoil LysB28ProB29 human insulin; B28-N-palmitoilysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N- (Npalmitoyl-Y-glutamyl) -des (B30) human insulin; B29-N- (N-litocolyl-Yglutamil) -des (B30) human insulin; B29-N- (w-carboxy-heptadecanoyl) des (B30) human insulin and B29-N- (w-carboxy-heptadecanoyl) human insulin.
    [0042] 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-SerLys-Gln- Met-Glu-GIu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-LysAsn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser- NH2.
    [0043] Exendin-4 derivatives are, for example, selected from the following list of compounds:
    [0044] H- (Lys) 4-des Pro36, des Pro37 Exendin-4 (1-39) -NH2, H (Lys) 5-des Pro36, des Pro37 Exendin-4 (1-39) -NH2, des Pro36 [Asp28] Exendin-4 (1-39), des Pro36 [lsoAsp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, IsoAsp28] Exendin-4 (1-39), des Pro36 [Trp (02) 25, Asp28] Exendin-4 (1-39), des Pro36 [Trp (02) 25, IsoAsp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (02) 25, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (02) 25, IsoAsp28] Exendin-4 (1-39); or [0045] des Pro36 [Asp28] Exendin-4 (1-39), des Pro36 [lsoAsp28]
    Exendin-4 (1-39), des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, IsoAsp28] Exendin-4 (1-39), des Pro36 [Trp (02) 25, Asp28] Exendin-4 (1-39), des Pro36 [Trp (02) 25, IsoAsp28] Exendin4 (1-39), des Pro36 [Met (O) 14 Trp (02) 25 , Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (02) 25, IsoAsp28] Exendin-4 (1-39), where the -Lys6-NH2 group can be connected to the terminal C of the Exendin-4 derivative; [0046] or an Exendin-4 derivative of the H- (Lys) 6-des sequence
    Pro36 [Asp28] Exendin-4 (1-39) -Lys6-NH2, des Asp28 Pro36, Pro37,
    Petition 870190097706, of 09/30/2019, p. 23/51
    17/36
    Pro38Exendin-4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro38 [Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5des Pro36, Pro37, Pro38 [ Asp28] Exendin-4 (1-39) -NH2, des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (139) - (Lys) 6-NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6-NH2 , H- (Lys) 6-des Pro36 [Trp (02) 25, Asp28] Exendin-4 (1-39) -Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Trp (02) 25] Exendin- 4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (02) 25, Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5 -des Pro36, Pro37, Pro38 [Trp (02) 25, Asp28] Exendin-4 (1-39) -NH2, des Pro36, Pro37, Pro38 [Trp (02) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (02) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H-Asn ( Glu) 5-des Pro36, Pro37, Pro38 [Trp (02) 25, Asp28] Exendin-4 (1-39) (Lys) 6- NH2, H- (Lys) 6-des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39) Lys6-NH2, des Met (O) 14 Asp28 Pro36, Pro37, Pro38 Exendin-4 (1-39) NH2, H- (Lys) 6-desPro36, P ro37, Pro38 [Met (O) 14, Asp28] Exendin4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1 -39) -NH2, des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H-Asn- (Glu) 5 des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin- 4 (1-39) - (Lys) 6NH2, H-Lys6-des Pro36 [Met (O) 14, Trp (02) 25, Asp28] Exendin-4 (139) -Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met (O) 14, Trp (02) 25] Exendin-4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (02) 25, Asp28] Exendin-4 (1-39) -NH2 , des Pro36, Pro37, Pro38 [Met (O) 14, Trp (02) 25, Asp28] Exendin-4 (1-39) (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (02) 25, Asp28] Exendin-4 (S1-39) - (Lys) 6-NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O ) 14, Trp (02) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2;
    Petition 870190097706, of 09/30/2019, p. 24/51
    18/36 [0047] or a pharmaceutically acceptable salt or solvate of any of the aforementioned Exedin-4 derivatives.
    [0048] Hormones are, for example, pituitary hormones or hypothalamic hormones, or regulatory active peptides and their antagonists as listed in Liste rote, ed. 2008, chapter 50, such as Gonadotropin (Folitropine, Lutropin, Choriongonadotropin, Menotropin), Somatropin (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
    [0049] A polysaccharide is, for example, a glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin, or a derivative thereof, or a sulphated form polysulphate of the polysaccharides mentioned above, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a low molecular weight polysulfated heparin is enoxaparin sodium.
    [0050] Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. The acid addition salts are, for example, the HCl or HBr salts. Basic salts are, for example, salts that have a cation selected from alkali or alkali, for example, Na +, or K +, or Ca2 +, or an N + (R1) (R2) (R3) (R4) ammonium ion, wherein R1 to R4 independently of one another means: 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. Other 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 Encyclopedia of Pharmaceutical
    Petition 870190097706, of 09/30/2019, p. 25/51
    19/36
    Technology.
    [0051] Pharmaceutically acceptable solvates are, for example, hydrates.
    [0052] The scope of the invention is described by the content of the claims. The invention is not limited to specific modalities, but comprises any combination of elements of different modalities. In addition, the invention comprises any combination of claims and any combination of characteristics indicated by the claims.
    BRIEF DESCRIPTION OF THE DRAWINGS [0053] The exemplary modalities are described here with reference to the drawings, in which:
    [0054] figure 1 illustrates a pen-type drug delivery device;
    [0055] figure 2 illustrates a cartridge that can be loaded in a cartridge holder of the pen type drug application device illustrated in figure 1;
    [0056] figure 3 illustrates an arrangement of a cartridge holder that includes coding elements that help to dedicate the cartridge holder to a particular dose adjustment member;
    [0057] figure 4A shows the interaction of exemplifying coding elements in a cartridge holder with the exemplifying coding elements in a dose adjustment member;
    [0058] figure 4B also shows the interaction of exemplifying coding elements in a cartridge holder with the exemplifying coding elements in a dose adjustment member;
    [0059] figure 5A shows a coding passage associated with an exemplary arrangement of coding elements;
    [0060] Figure 5B shows another coding pass asPetition 870190097706, of 30/09/2019, pg. 26/51
    20/36 associated with an exemplary arrangement of coding elements; [0061] figure 5C shows another coding pass associated with an exemplary arrangement of coding elements;
    [0062] figure 6A shows an exemplary arrangement of pin elements in a cartridge holder;
    [0063] figure 6B shows another exemplary arrangement of pin elements in a cartridge holder;
    [0064] figure 6C shows another exemplary arrangement of pin elements in a cartridge holder;
    [0065] figure 7 shows an exemplary cartridge holder that has an ejection element;
    [0066] figure 8 shows an exemplary cartridge holder that has a pin element pin that extends proximally to the shoulder of the cartridge holder;
    [0067] figure 9 shows an exemplary cartridge holder that has a pin element that extends proximally to the proximal end of the cartridge holder;
    [0068] figure 10A shows exemplary cross sections of the coding elements; and [0069] figure 10B shows exemplary cross sections of the coding elements from a perspective different from that shown in figure 10A.
    DETAILED DESCRIPTION [0070] Referring to figure 1, a drug delivery device 10 in the form of a pen-type syringe is shown. That drug delivery device 10 comprises a dose adjustment member 12 that serves as a drug delivery and adjustment mechanism, a cartridge holder 14, and a removable cap 16. A proximal end 15 of the cartridge holder 14 and an end distal 13 of the dose adjusting member 12 are attached to each other
    Petition 870190097706, of 09/30/2019, p. 27/51
    21/36 removably. The pen-type syringe may comprise a reusable or disposable pen-type syringe. Where the syringe comprises a reusable device, the cartridge holder 14 and the dose adjustment mechanism are removably coupled to each other. In a disposable device, they can be permanently attached to each other. When the drug delivery device is not in use, the removable cap 16 can be held removably on the cartridge holder 14.
    [0071] The cartridge holder contains a removable cartridge 20 containing a medicament 25. With reference to figure 1, the cartridge holder 14 houses a removable cartridge 20. Figure 2 illustrates a perspective view of the cartridge 20 that can be used with the drug delivery device shown in figure 1.
    An internal cartridge cavity 11 defined by the cartridge holder 14 is sized and configured to receive and firmly hold the cartridge 20. The cartridge 20 includes a generally tubular drum 22 extending from a distal end 31 to a proximal end 32. The distal end 31 is defined by a converging internal shoulder 70.
    [0073] At the distal end 31, the cartridge 20 includes a throat of smaller diameter 26, and that throat 26 projects distally from the shoulder 70 of the drum 22. Preferably, this throat of smaller diameter 26 is provided with an annular bead in diameter large (not shown) and this granule extends circumferentially around the extreme distal end of the throat 26. A perforable seal or septum 21 is firmly mounted through the open distal end defined by the throat. The seal 21 can be held in place by a metal glove 24. This glove 24 can be crimped around the circumferential granule at the distal end of the throat 26. The medicine is pre-loaded in the cartridge 20 and is kept inside the cartridge, in
    Petition 870190097706, of 09/30/2019, p. 28/51
    22/36 part, through the piercable seal 21, the metallic sleeve 24, and the plug 28. The plug 28 is in a fluid-impermeable sliding coupling with the inner tubular wall of the drum 22. The forces directed axially in the distal direction to the plug 28 during dose administration, force the medication from the cartridge 20 through a double-ended needle mounted on the distal end of the cartridge holder 14.
    [0074] A series of doses of a drug can be applied from cartridge 20. Preferably, cartridge 20 contains a type of drug that should be administered frequently, such as once or more times a day. Such a drug is insulin. A movable piston that also serves as plug 28 is retained at a first or proximal end of the cartridge 20.
    [0075] A part of the cartridge holder 14 that defines the cartridge holder cavity, which is formed by the inner cylindrical wall of the cartridge holder 14, is of a substantially uniform diameter and is smaller than the cartridge diameter of the cartridge 20 represented in figure 2 by D1. The interior of the cartridge holder 14 includes an inwardly extended ring portion or retainer 18 which is sized to prevent the cartridge 20 from moving inside the cartridge holder 14. In this way, when the cartridge 20 is loaded into the cavity 11 of the cartridge holder cartridge 14 and the cartridge holder 14 is then connected to the dose adjusting member 12, the cartridge 20 is securely fastened within the cartridge cavity 11.
    [0076] The dose adjustment member 12 comprises a dose adjuster 17 at the proximal end of the dose adjustment member 12. In a preferred arrangement, dose adjuster 17 is rotated to adjust a dose. To administer this adjusted dose, the user attaches the needle assembly (not shown) comprising a double-ended needle to the distal end of the cartridge holder 14. In this way, the needle assembly pierces the seal 21 of the cartridge 20 and,
    Petition 870190097706, of 09/30/2019, p. 29/51
    Therefore, it is in liquid communication with the medication. The user pushes the dose adjuster 17 to inject the adjusted dose. The same dose adjustment and dose administration procedure is followed until the medicine in cartridge 20 runs out and then a new cartridge must be loaded in device 10. To change an empty cartridge 20, the user must then remove the cartridge 14 of dose adjustment member 12.
    [0077] In general, the dedication of the cartridge (for example, the coding of a particular cartridge holder to a compatible dose adjustment member) can be achieved by arranging coding elements on the cartridge holder 14 to align with elements of coding on the corresponding dose adjustment member 12 so as to require an identifiable connection passage (for example, a distinct sequence of axial, helical, and / or rotational movements) and / or prevent cartridge holders 14 and limbs from dose adjustment 12 that do not match are connected. Typically, the coding elements align so that rotation in one direction (i.e., clockwise or counterclockwise) causes the shoulder of the cartridge holder 14 and the distal end 13 of the adjustment member dose switches move towards each other, or, in other words, connect the cartridge holder 14 and the dose adjustment member 12. Rotation in the opposite direction can therefore disconnect the cartridge holder 14 and the adjustment member dose 12 (for example, causes the shoulder of the cartridge holder 14 and the distal end 13 of the dose adjusting member 12 to move when they are moved away from each other).
    [0078] Figure 3 illustrates a first arrangement of a cartridge holder 300 that includes coding elements that help to dedicate the cartridge holder 300 to a particular dose adjustment member 302. The cartridge holder 300 has a tubular body that has a
    Petition 870190097706, of 09/30/2019, p. 30/51
    24/36 cylindrical internal surface that defines the cavity for containing a medicine cartridge. The cartridge holder 300 and the connector portion 309 define a cylindrical inner wall and a cylindrical outer wall 314. The tubular body extends from the retainer (not shown) to a shoulder 306.
    [0079] The shoulder 306 is arranged in such a way that, when the cartridge holder 300 is connected to the dose adjustment member 302, the proximal side of the shoulder 306 rests flush against the distal end 308 of the dose adjustment member 302. A portion 309 of the cartridge holder connector 300 extends from the shoulder 306 to a proximal end 310 of the cartridge holder 300. The fixing groove 316 on the 309 portion of the connector engages in the retaining pin 328 on the inner surface of the member dose adjustment 302 to form the fixing means for connecting the cartridge assembly to the dose adjusting member 302. The fixing pin 328 can move longitudinally into the groove 316 for its end portion 317. Likewise, it must be understood that modalities with a single groove element or more than two groove elements, as well as modalities with groove elements of different shapes, are also possible. Alternatively, the fixing groove 316 could be located on the dose adjusting member 302 and the fixing pin 328 could be positioned on the cartridge assembly. Certainly, in general, any fastening element known in the injection device art can be used.
    [0080] Also included in the connector portion 309 is a coding element, illustrated as a retainer 318. That coding element has a complementary coding element in the dose setting member 302, shown as a counter-retainer 330. More generally , a coding element can be any indentation or protrusion, in any direction of any size, and / or from which
    Petition 870190097706, of 09/30/2019, p. 31/51
    25/36 either format, of a cartridge holder 300 or dose adjustment member 302. As illustrated, the coding element 318 is a square-shaped protrusion, however, such retaining elements may vary in size, shape , and location. For example, a coding element can be described by helical, rotational, and / or axial surfaces of varying number and length. Preferably, these coding elements on the cartridge holder 300 and on the dose setting member 302 are coded in such a way that, if the particular cartridge holder is not intended for the particular dose setting member, the coding elements will prevent proper connection, or else they will indicate that cartridge holder 300 and dose adjusting member 302 are not matching.
    [0081] Figures 4 to 6 show in more detail the interaction between the coding elements in the cartridge holder 300 and in the dose adjustment member 302, illustrated as projections around the circumference. The shaded elements are in one part and the smooth elements are in the other part, for example, if the shaded elements are in the dose adjustment member 302, then the smooth elements must be in the cartridge holder 300. In particular, figure 4A shows the interaction of the coding elements 316 and 318, and the seals 328, 328a, 330 and 330a. It should be noted that a second set of coding elements 316a and 318a, which may be identical to coding elements 316 and 318, are also illustrated. The various coding elements in the dose setting member 302 can work together to help dedicate a particular cartridge holder 300 to the particular dose setting member 302. For example, figures 4A and 4B show how the coding elements of the cartridge holder 300 preferably align with the coding elements of the
    Petition 870190097706, of 09/30/2019, p. 32/51
    26/36 if 302 when connected correctly. In particular, when the correctly connected retaining element 318 couples firmly to the counter-retainer 330.
    [0082] More specifically, the clamping groove element 316 and the clamping pin element 328 are configured in such a way that the cartridge holder 300 and the dose adjustment member 302 can be connected by guiding the pressure adjustment member dose axially, helically, and then rotationally, until the axial surface 348 of the cartridge holder 300 contacts the axial surface 358 of the dose setting member 302. A proximal surface 346 of the cartridge holder 300 comes into contact with a distal surface 356 of the dose adjustment member 302. This arrangement thus helps to code the cartridge holder 300 to the dose adjustment member 302. And, if the fixing pin element 328 is not coded to match the fixing groove 316, then the pin element will be blocked (for example, the pin element has an axial extension greater than the axial extension of the groove element between the proximal and distal helical surfaces 340, 342), u then does not fit tightly (for example, the pin element has an axial extension less than the axial extension of the groove element between the proximal and distal helical surfaces 340, 342). Although the main coding is between 330 and 318, the coding can also be from the fixing pin to the groove. In addition, if the coding element 330 is not coded to match the coding element 318, then the coding element 318 can come in contact with the coding element 330 too soon and thereby prevent the mounting of the fixing pin completely. 328 in the groove fixing element 342.
    [0083] Figure 4B shows an alternative modality that also comprises the fixing groove elements 416, 416a and the elements
    Petition 870190097706, of 09/30/2019, p. 33/51
    27/36 fixing pin contacts 428, 428a where the coding elements 418, 418a are counterspindles located on the dose adjustment member and coded to couple with the retainers 430, 430a when making contact along at least the axial face. However, the contact between the retaining elements can be in any direction, such as axial, helical or circumferential, although the contact direction is preferably normal to the direction of travel at the time of contact. For example, in other embodiments, such as those shown in figures 5A, 5B and 5C, the coding elements that have a longitudinal portion 510a-c and radial portions 512a-c, block both rotational and axial movement.
    [0084] In preferred embodiments, the fixation means must follow the same course for all drugs in the coding system, but the coded blocking or retaining elements must be displaced from the fixation means by a different amount for each drug. In this way, coding can be carried out, at least in part, by varying the axial, radial and / or circumferential position of the coding elements so as to vary the axial, radial and / or circumferential position of the coding stroke. The pin and groove of the fixing assembly are not shown, but the pin assembly in the groove guides the coding elements along the coding passages illustrated as dotted lines. The shape of the coding stroke is therefore defined by the clamping action, for example, the clamping pin 328 following the clamping groove element 316, but its position passes through the coding elements. For example, figures 5A-C show three different possible coding strokes 502, 504 and 506, which can be obtained by using various configurations of coding elements. In this way, each coding course can be used to dedicate a cartridge holder for a particular medication to its corresponding dose adjustment member. Petition 870190097706, of 30/09/2019, p. 34/51
    28/36 te.
    [0085] If there is only one coded retaining element, then a cartridge holder where the stroke of the retaining element is blocked in the fastening action will fit into a device where the stroke is blocked later. The same problem exists with more than one retaining element, if all the retaining elements for a certain drug are displaced by the same distance in relation to another drug. Figures 5A-C show a coding system that depends on more than one blocking or retention surface, so that all drugs can be prevented from being fitted to an incorrect device. Figure 5B shows both elements in their central position. For the other drugs, that is, in figures 5A and 5C, a coding element is moved to the beginning of the fixation course, and a coding element is moved later in the fixation course. In this way, none of the cartridge assemblies in the system can be fitted to incorrect devices.
    [0086] Figures 6A-C also illustrate exemplary cartridge holders having multiple locking or retaining faces, which combine with corresponding coding elements on the corresponding dose adjustment members. In particular, when a user moves the coding elements 610a and 620a that encode through the course 602, the coding elements 610a and 620a of the dose adjusting member engage with the elements 612a and 622a of the cartridge holder, indicating to the user that the appropriate connection has been obtained. Similarly, elements 610b and 620b can be moved through coding stroke 604 to mate with elements 612b and 622b, and elements 610c and 620c can be moved through coding stroke 606 to engage with elements 612c and 622c.
    Petition 870190097706, of 09/30/2019, p. 35/51
    29/36 [0087] Since the elements of each of the pairs of elements 610a / 620a, 610b / 620b and 610c / 620c (and their elements
    612a / 622a, 612b / 622b and 612c / 622c (corresponding or complementary in the dose adjustment members), are oriented differently with respect to each other, a couple may block the course sooner or later in the connection process than another pair, thereby helping to dedicate a particular cartridge to its corresponding dose adjustment member. Figure 6A shows both elements in their central position. For the other drugs, that is, in figures 6B and 6C, a coding element is moved to the beginning of the fixation course, and a coding element is moved later in the fixation course. In this way, none of the cartridge assemblies in the system can be fitted to incorrect devices.
    [0088] In another aspect, a cartridge holder may include an ejection element, which ejects the cartridge holder if it is inserted into the incorrect dose adjustment member. Figure 7 shows an exemplary cartridge holder 700 that has an ejection element. In particular, the groove fixing element on the cartridge holder 700 can include an ejection channel 710. As shown, the coding elements are arranged to provide the coded retaining elements 718 and 730 which are arranged to couple and lock the rotational movement when properly connected. These retainers prevent the rotational movement of the fixing pin element 728 of the dose adjustment member 702 in the ejection channel 710. However, if the cartridge holder 700 is inserted into a mismatched dose adjustment member 702, this that is, the retainers 718 and 730 do not engage, so the fixing pin element 728 on the dose setting member 702 may override in the ejection channel 710. Once in that channel, the pin 728 becomes loose and it will be obvious to the user that the fixing operation failed. As an additional security measure, the
    Petition 870190097706, of 09/30/2019, p. 36/51
    30/36 cartridge assembly 700 or dose adjusting member 702 can be designed in such a way that an additional rotation in the clamping direction will force the pin through or into a one-way element. In particular, once in this one-way element, the fixation pin comes into contact with a ramp, and the support (or device) flexes to allow the pin to pass to the beginning of one of the fixation grooves. The side of the single-track element adjacent to the groove has a more acute angle, so that the pin cannot return, or penetrate the ejection channel during normal fixation. In addition, a spring mechanism can be added to the device to force the cartridge holder in a distal direction, thereby ejecting the dose adjustment member helping to ensure that only the correct cartridge holder is connected.
    [0089] Figure 8 shows an alternative embodiment, which includes a retaining element 818 that extends proximally to the shoulder 809 of the cartridge holder 800. The retaining element 818 is coded to match a coded groove element 830 on the member dose adjustment 802. Specifically, to correctly connect cartridge holder 800 to dose adjustment member 802, retainer 818 is helically moved along helical surface 820 until the proximal edge of retainer 818 comes into contact. contact with the surface 822 of the groove element 830. The cartridge holder 800 is then rotated until the retaining element contacts the axial surface or counter face 824 of the groove element 830, thereby interrupting the rotational movement. This arrangement can be more compact than other modalities, and the shoulder can help protect the 818, 830 encoding elements from damage.
    [0090] Figure 9 shows another alternative modality, which includes a retaining element 918 that extends proximally to the
    Petition 870190097706, of 09/30/2019, p. 37/51
    31/36 proximal end 910 of the cartridge holder 900. Unlike the other retaining elements discussed here, this coding element 918 does not protrude radially from the outer wall of the cartridge holder, but protrudes proximally from the proximal end 910 of the cartridge holder. The coding element corresponding to the retaining element 918 in the dose adjustment mechanism 902 is the coded groove element 928 a with a counter-retaining face 931. The groove element 928 is an axial cutout in a circular rib 930 of the adjustment mechanism. dose 902. Circular rib 930 is preferably arranged in such a way that, when properly connected, the rib comes into contact (or almost comes in contact) with the proximal end 910 of cartridge holder 900. In this way, if the element retainer 918 comes into contact with the rib (and is not inserted into the groove element 930), a spacing will remain between the distal end 914 of the dose adjustment mechanism 902 and the shoulder 909 of the cartridge holder 900. This spacing can therefore, serve to indicate an incorrect connection to the user.
    [0091] In an additional aspect, any coding element of the cartridge holder and / or the dose adjustment member may vary in size and shape in one or more planes (for example, in the transverse, longitudinal and / or radial planes ). For example, figure 10A shows an exemplary collection of retaining elements that have cross sections 102-112 across a cross plane, each of which can be used for a different drug. The cross section for each drug is larger in one area and smaller in another than for all other drugs, which can be seen when overlapping all cross sections in sketch 100. In this way, if the wrong cartridge holder is inserted into the device , the retainer will block the course before the support is completely assembled
    Petition 870190097706, of 09/30/2019, p. 38/51
    32/36 te. Figure 10B shows another collection of possible coding elements that have cross sections 1102-1112, but across the longitudinal plane (i.e., the normalized plane for the curvature of the coding element). The cross section for each drug is larger in one area and smaller in another than for all other drugs, which can be seen by overlapping all cross sections in outline 1100. A particular coding element can be coded in such a cross plane as in 10A, or can be encoded in a longitudinal plane such as in 10B, or both.
    [0092] Each retainer may vary in shape and size. For example, as shown in figure 10A, the retainers may vary in radial extent and / or circumferential extent (for example, retainers 102-106 are radially narrower and circumferentially longer than retainers 108-112). The coding elements may also vary in axial extent and the edges may vary angularly. For example, as shown, both edges of retainer 102 and both edges of retainer 108 are normal to the circumference of the coding element (and thus to the circumference of the outer cylindrical wall of the cartridge holder), while each of the retainers 104, 106, 110, and 112 include an edge that is normal to the circumference, and an edge that is angular to the circumference.
    [0093] In another aspect, the coding elements may include electromechanical verification elements; for example, electrical or optical sensors, micro-switches, optical switches, magnetic switches, etc. For example, when a cartridge holder is connected to the correct dose setting member, a switch on one edge of a coding element (on the cartridge holder and / or the dose setting member) can be activated. As another example, a sensor in the coding element of a cartridge holder can be configured to detect a compatible sensor in the
    Petition 870190097706, of 09/30/2019, p. 39/51
    33/36 coding element of the compatible dose adjustment member. The cartridge holder sensor can be located so that it aligns only with (and thereby detects) the compatible sensor on the dose adjustment member when properly connected. In this way, a programmable drug delivery device can be disabled until the switch is activated or the sensors are placed in alignment, helping to prevent incorrect drug delivery.
    [0094] Applicant's cartridge holders and dose adjustment members help provide a large number of different encoding configurations. Therefore, with the proposed coding elements, medicines from a large number of medicines can be distinguished from each other. In addition, with the proposed coding elements, if a user tries to load an incorrect reservoir in a cartridge holder for a different cartridge, the user will be alerted at an early stage in the assembly process.
    [0095] The exemplary modalities have been described. It should be understood that, in general, the functionality and structural aspects described herein with reference to pin or groove elements in a cartridge holder can apply equally with respect to the pin or groove elements in a dose adjustment member . Those skilled in the art will understand, however, that changes and modifications can be made to these arrangements without departing from the true scope and character of the present invention, which is described by the claims.
    Reference List drug application device cartridge cavity dose adjustment member
    Petition 870190097706, of 09/30/2019, p. 40/51
    34/36 distal end cartridge holder proximal end cap dose adjuster retains seal cartridge drum glove medicine throat plug distal end proximal end boss cartridge holder dose adjustment member boss distal end portion proximal end wall 316a groove end portion
    318a retains
    328a pin element
    330a retains
    342 distal helical surface 356 surface
    Petition 870190097706, of 09/30/2019, p. 41/51
    35/36
    348, 358 surface
    416 416a groove
    418, 418a retains
    428 pin
    430, 430a retains
    502, 504, 506 coding courses
    510a-c longitudinal portion
    512a-y radial portions
    602, 604, 606 coding blocks
    610a, 610a, 620a, 622a holds
    610b, 612b, 620b, 622b retain
    610c, 612c, 620c, 622c retain
    700 cartridge holder
    702 dose adjustment member
    710 ejection channel
    718, 730 retains
    728 pin
    800 cartridge holder
    802 dose adjustment member
    809 bounce
    818 retains
    820 helical surface
    822 surface
    824 retains
    830 groove
    900 cartridge holder
    902 dose adjustment member
    909 bounce
    910 proximal end
    914 distal end
    Petition 870190097706, of 09/30/2019, p. 42/51
    36/36
    918 withhold 928 groove 930 circular rib 931 retaining face 100 outline 102, 108 edges 102-112 transversal section 1100 outline
    1102-1112 cross section
    102-106, 108-112 holds
    权利要求:
    Claims (13)
    [1]
    1. Cartridge set (14, 300, 700, 800, 900) configured to be connected to a dose adjustment and application mechanism (12, 302, 702, 802, 902), in which the cartridge set (14, 300, 700, 800, 900) comprises:
    a cylindrical body for containing a medicament reservoir, wherein the cylindrical body has a proximal end portion (309) that has an outer surface (314) and an inner surface; a retainer (316, 316a, 416, 416a) on the outer surface (314) or on the inner surface of the proximal end portion (309), where the retainer (316, 316a, 416, 416a) is configured to secure the assembly from cartridges (14, 300, 700, 800, 900) to the drug adjustment and application mechanism (12, 302, 702, 802); and at least one coding element (318, 318a, 418, 418a, 610a-c, 620a-c, 718, 918) which is separate from the retainer (316, 316a, 416, 416a), wherein the coding element ( 318, 318a, 418, 418a, 610a-c, 620a-c, 718, 918) is coded to couple with a corresponding coding element (330, 330a, 430, 430a, 510a-c, 512a-c, 612a-c , 622a-c, 730, 931) in the drug application and adjustment mechanism (12, 302, 702, 802, 902), thereby allowing the cartridge set (14, 300, 700, 800, 900) to connect operation mode to the dose adjustment and application mechanism (12, 302, 702, 802, 902), in which the coding element (318, 318a, 418, 418a, 718, 918) is formed as a retaining element and in which the corresponding coding element (330, 330a, 430, 430a, 510 ac, 512a-c, 612a-c, 622a-c, 730, 931) is formed as a counter-retaining element, wherein the retaining element and the counter-retention are appropriate for making contact, thereby blocking the course in the proces connection method and allowing the set of cartridges (14, 300, 700, 800, 900) to connect operatively to the
    Petition 870190097706, of 09/30/2019, p. 44/51
    [2]
    2. Set of cartridges (14, 300, 700, 800, 900), according to claim 1, characterized by the fact that the retaining element is located on the outer surface (314), or on the inner surface, or in a axial end of the cylindrical body.
    2/4 dose adjustment and application (12, 302, 702, 802, 902), characterized by the fact that the proximal outer surface (314) of the cylindrical body is positioned between a shoulder (306, 809) and a proximal axial end (310) and the retainer (316, 316a, 416, 416a) is positioned on the proximal outer surface (314) and where the coding element (818) of the cartridge assembly (14, 300, 700, 800, 900) is a pin on the proximal outer surface (314), where the pin abuts a proximal facing surface of the shoulder (306, 809).
    [3]
    3/4 cation 6, characterized by the fact that the set of cartridges (900) is configured to be rotated until the pin contacts a counter-retaining face (931) of a groove element (928) which is a cutout axial in a circular rib (930) of the dose adjustment and application mechanism (902).
    3. Set of cartridges (14, 300, 700, 800, 900) according to claim 1 or 2, characterized by the fact that the retaining element is configured to contact the counter-retaining element in an axial direction , helical or circumferential.
    [4]
    4/4 operating mode with the first dose adjustment and application mechanism (14, 300, 700, 800, 900).
    4. Set of cartridges (14, 300, 700, 800, 900), according to claim 3, characterized by the fact that the retaining element is configured to contact the counter-retaining element in the direction that is normal to the direction of travel of the cartridge assembly (14, 300, 700, 800, 900) at the time of contact.
    [5]
    Cartridge assembly (14, 300, 700, 800) according to any one of claims 1 to 4, characterized in that the coding element (318, 318a, 418, 418a, 718) comprises a radial pin .
    [6]
    Cartridge assembly (900) according to any one of claims 1 to 4, characterized in that the coding element (918) comprises an axial pin.
    [7]
    7. Set of cartridges (900) according to claim
    Petition 870190097706, of 09/30/2019, p. 45/51
    [8]
    8. Set of cartridges (14, 300, 700, 800, 900) according to any one of claims 1 to 7, characterized by the fact that the retainer (316, 316a, 416, 416a) is selected from the group consisting of in threads, pins and grooves, pins and ribs, bayonet, pressure adjustment, and struts.
    [9]
    9. Cartridge set (14, 300, 700, 800, 900) according to any one of claims 1 to 8, characterized by the fact that it has an ejection channel (710) where, if the retaining element (718 ) and the locking element (730) do not engage, so a locking pin element (728) on the dose adjustment member (702) may override in the ejection channel 710.
    [10]
    10. First and second set of cartridges (14, 300, 700, 800, 900), as defined in any of claims 1 to 9, characterized by the fact that the first set of cartridges (14, 300, 700, 800, 900) contains a first drug and the second set of cartridges (14, 300, 700, 800, 900) contains a second drug different from the first drug and where the coding element (318, 318a, 418, 418a, 610a-c, 620a-c, 718, 918) of the first set of cartridges (14, 300, 700, 800, 900) is unique to the first drug and is specifically coded to couple with only one coding element (330, 330a, 430, 430a , 510a-c, 512a-c, 612a-c, 622a-c, 730, 931) corresponding to a dose adjustment and application mechanism (12, 302, 702, 802, 902) that is configured to apply the first drug and the second set of cartridges (14, 300, 700, 800, 900) will not connect
    Petition 870190097706, of 09/30/2019, p. 46/51
    [11]
    11. First and second sets of cartridges (14, 300, 700, 800, 900), according to claim 10, characterized by the fact that the coding element (318, 318a, 418, 418a, 610a-c, 620a -c, 718, 918) of the second set of cartridges (14, 300, 700, 800, 900) is unique to the second drug and is specifically coded to couple with only one coding element (330, 330a, 430, 430a, 510a-c, 512a-c, 612a-c, 622a-c, 730, 931) corresponding to a dose adjustment and application mechanism (12, 302, 702, 802, 902) that is configured to apply the second drug.
    [12]
    12. First and second cartridge sets (300, 700, 800, 900) according to claim 10 or 11, characterized by the fact that a third set of cartridges (14, 300, 700, 800, 900) contains a third drug other than the first and second drugs, wherein the coding element (318, 318a, 418, 418a, 610a-c, 620a-c, 718, 918) of the third set of cartridges (14, 300, 700, 800, 900) is unique for the third drug and in which the third set of cartridges (14, 300, 700, 800, 900) operatively connects only to a third dose adjustment and application mechanism (12, 302, 702, 802 , 902) which is different from other dose adjustment and application mechanisms (12, 302, 702, 802, 902).
    [13]
    13. First and second cartridge sets (300, 700, 800, 900) according to claim 10, 11 or 12, characterized by the fact that the cartridge sets (300, 700, 800, 900) have the same type of retainers (316, 316a, 416, 416a), and where the coding element (318, 318a, 418, 418a, 610a-c, 620a-c, 718, 918) of the first set (14, 300, 700 , 800, 900) is different from the coding element (318, 318a, 418, 418a, 610a-c, 620a-c, 718, 918) of the second set (12, 300, 700, 800, 900).
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    同族专利:
    公开号 | 公开日
    DK2560708T3|2018-01-22|
    AU2011244237B2|2015-01-22|
    SG184502A1|2012-11-29|
    PL2560708T3|2018-03-30|
    DE202011110696U1|2015-09-02|
    NO2560708T3|2018-03-17|
    WO2011131783A2|2011-10-27|
    US20130131604A1|2013-05-23|
    CN102946927A|2013-02-27|
    ES2654154T3|2018-02-12|
    MY163102A|2017-08-15|
    RU2012149866A|2014-05-27|
    CA2796792A1|2011-10-27|
    US9242046B2|2016-01-26|
    IL222527D0|2012-12-31|
    HUE036135T2|2018-06-28|
    CN102946927B|2015-01-21|
    US20150202371A1|2015-07-23|
    US9180251B2|2015-11-10|
    ZA201207362B|2013-06-26|
    MX2012012325A|2013-01-29|
    EP2560708A2|2013-02-27|
    EP2560708B1|2017-10-18|
    KR20130092422A|2013-08-20|
    JP5815672B2|2015-11-17|
    JP2013524909A|2013-06-20|
    AU2011244237A1|2012-11-08|
    WO2011131783A3|2011-12-22|
    BR112012027109A2|2016-07-26|
    RU2573942C2|2016-01-27|
    NZ603118A|2014-09-26|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    DE3715258C2|1987-05-08|1996-10-31|Haselmeier Wilhelm Fa|Injection device|
    IL160044D0|2001-08-27|2004-06-20|Novo Nordisk As|A cartridge and a medical delivery system accommodating such cartridge|
    CN101479004B|2006-06-30|2012-06-20|诺沃-诺迪斯克有限公司|A medical delivery system comprising a coding mechanism|
    EP2043710B1|2006-07-15|2011-07-06|Novo Nordisk A/S|A medical delivery system with flexible blocking element|
    CN101489608B|2006-07-15|2012-10-10|诺沃-诺迪斯克有限公司|Medical delivery system with asymmetrical coding means|
    US8613731B2|2006-07-15|2013-12-24|Novo Nordisk A/S|Medical delivery system with asymmetrical coding means|
    WO2008059063A1|2006-11-17|2008-05-22|Novo Nordisk A/S|A medical delivery system comprising a coding mechanism between dosing assembly and medicament container|
    US8740857B2|2006-12-21|2014-06-03|Novo Nordisk A/S|Syringe device|EP1476210B1|2002-02-11|2008-09-24|Antares Pharma, Inc.|Intradermal injector|
    KR20070117543A|2005-01-24|2007-12-12|앤태어스 파머, 인코퍼레이티드|Prefilled needle assisted jet injector|
    WO2007131025A1|2006-05-03|2007-11-15|Antares Pharma, Inc.|Injector with adjustable dosing|
    WO2007131013A1|2006-05-03|2007-11-15|Antares Pharma, Inc.|Two-stage reconstituting injector|
    US8814834B2|2008-03-10|2014-08-26|Antares Pharma, Inc.|Injector safety device|
    ES2738539T3|2008-08-05|2020-01-23|Antares Pharma Inc|Multi dose injector|
    WO2010108116A1|2009-03-20|2010-09-23|Antares Pharma, Inc.|Hazardous agent injection system|
    TWI464002B|2010-11-08|2014-12-11|Shl Group Ab|Container holder assembly and medicament delivery device assembly|
    EP2460552A1|2010-12-06|2012-06-06|Sanofi-Aventis Deutschland GmbH|Drug delivery device with locking arrangement for dose button|
    DK2460551T3|2010-12-06|2016-08-15|Sanofi Aventis Deutschland|Drug delivery device with dose knob lock arrangement|
    US8496619B2|2011-07-15|2013-07-30|Antares Pharma, Inc.|Injection device with cammed ram assembly|
    US9220660B2|2011-07-15|2015-12-29|Antares Pharma, Inc.|Liquid-transfer adapter beveled spike|
    JP5823814B2|2011-10-25|2015-11-25|株式会社モリタ製作所|Medical system|
    US9486583B2|2012-03-06|2016-11-08|Antares Pharma, Inc.|Prefilled syringe with breakaway force feature|
    AU2013203784A1|2012-04-06|2013-10-24|Kaushik J. Dave|Needle assisted jet injection administration of testosterone compositions|
    IN2014DN08681A|2012-04-13|2015-05-22|Becton Dickinson Co|
    WO2013169800A1|2012-05-07|2013-11-14|Antares Pharma, Inc.|Injection device with cammed ram assembly|
    CA2900672C|2013-02-11|2018-03-27|Antares Pharma, Inc.|Needle assisted jet injection device having reduced trigger force|
    ES2742046T3|2013-03-11|2020-02-12|Antares Pharma Inc|Dose injector with pinion system|
    WO2014165136A1|2013-03-12|2014-10-09|Antares Pharma, Inc.|Constant volume prefilled syringes and kits thereof|
    US20140360894A1|2013-06-05|2014-12-11|Ethel Marlene Miles|Carpule to Store Lower Dosage Amount of Dental Anesthetic|
    DE102013018639A1|2013-11-06|2014-07-24|Fresenius Medical Care Deutschland Gmbh|Connector for connecting bag and hose system for providing e.g. medical solution during extraporal blood treatment for patient, has cone only opening sealing element when projection of one part is inserted in retainer of other part|
    USD773038S1|2014-05-27|2016-11-29|Wockhardt Limited|Self injection pen device|
    AU2015339382A1|2014-10-28|2017-05-11|Bayer Healthcare Llc|Self-orienting pressure jacket and pressure jacket-to-injector interface|
    US9199033B1|2014-10-28|2015-12-01|Bayer Healthcare Llc|Self-orienting syringe and syringe interface|
    NO2689315T3|2014-10-28|2018-04-14|
    CN107106761B|2014-10-28|2020-11-03|拜耳医药保健有限公司|Self-orienting pressure jacket and interface of pressure jacket to syringe|
    CN108472433B|2015-11-13|2021-12-14|拜耳医药保健有限公司|Nested syringe assembly|
    US11191893B2|2018-01-31|2021-12-07|Bayer Healthcare Llc|System and method for syringe engagement with injector|
    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-08-06| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-03-31| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-06-02| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/04/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US32728410P| true| 2010-04-23|2010-04-23|
    US61/327,284|2010-04-23|
    EP10171170|2010-07-29|
    EP10171170.3|2010-07-29|
    PCT/EP2011/056482|WO2011131783A2|2010-04-23|2011-04-21|Coded cartridge assembly|
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