Source: https://patents.google.com/patent/JP2012528628A/en
Timestamp: 2020-02-26 20:36:40
Document Index: 306859548

Matched Legal Cases: ['art 2', 'art 4', 'art 2', 'art 2', 'art 244', 'art 246', 'art 407']

JP2012528628A - Spindle for drug delivery device - Google Patents
Spindle for drug delivery device Download PDF
JP2012528628A
JP2012528628A JP2012513569A JP2012513569A JP2012528628A JP 2012528628 A JP2012528628 A JP 2012528628A JP 2012513569 A JP2012513569 A JP 2012513569A JP 2012513569 A JP2012513569 A JP 2012513569A JP 2012528628 A JP2012528628 A JP 2012528628A
JP2012513569A
JP5903042B2 (en
2009-06-01 Priority to US61/182,856 priority
2010-05-28 Priority to PCT/EP2010/057486 priority patent/WO2010139640A1/en
2012-11-15 Publication of JP2012528628A publication Critical patent/JP2012528628A/en
2016-04-13 Publication of JP5903042B2 publication Critical patent/JP5903042B2/en
A spindle (242; 414; 542; 642) is provided for driving the cartridge plug. The spindle includes a generally circular shaft having an outer surface (560). A generally circular shaft extends from the distal end to the proximal end of the circular shaft. A first spiral groove (219; 519; 619) is provided along the first portion of the outer surface. The first spiral groove has a first pitch. The second helical groove (221; 521; 621) is provided along a second portion of the outer surface of the generally circular axis. The second spiral groove overlaps the first spiral groove. The second spiral groove has a second pitch.
This patent application relates generally to a spindle for use with a dose setting mechanism of a drug delivery device. More particularly, this patent application generally relates to a spindle for use with a drug delivery device, such as a pen-type drug delivery device. Such a device provides self-administration of medication from a multi-dose cartridge and allows the user to set the delivery dose. The application may find use in both disposable and reusable types of drug delivery devices. However, aspects of the invention are equally applicable to other situations.
Pen-type drug delivery devices have applications when regular injections are made by people who do not have formal medical training. This may become increasingly common among patients with diabetes, where such patients can perform effective management of their illness through self-care.
One such prior art pen-type drug delivery device is described in US Pat. U.S. Pat. No. 6,057,089 is incorporated in full by reference to this specification and by directing the reader to any further information.
As illustrated in FIGS. 1-5, drug delivery devices in multiple operating positions are shown: positions for dose setting and dose administration or injection. The drug delivery device includes a housing having a first cartridge holding part 2 and a second main (external) housing part 4. A cartridge 8 from which a number of pharmaceutical doses can be administered is provided in the cartridge holder part 2. The piston 10 is held in the first end of the cartridge. The removable cap 12 is held releasably over the second end of the cartridge holding part 2.
An insert 16 is provided at the first end of the main housing 4 and is secured against rotational or longitudinal movement. The insert 16 is provided with a threaded circular opening 18. The first spiral groove 19 extends from the first end of the spindle 20. The spindle 20 is generally circular in cross section. The first end (distal end) of the spindle 20 extends through the insert 16 through a threaded opening 18. The second spiral groove 24 extends from the second end (proximal end) of the spindle 20. In the illustrated arrangement, the second spiral groove 24 includes a series of partial spiral grooves rather than a full spiral groove.
The first spiral groove 19 and the second spiral groove 24 are arranged in opposite directions, that is, the grooves are in opposite directions. A receiving recess is provided at the second end (ie, proximal end) of the spindle 20. The driver 30 is provided with a flange 32 extending around the spindle 20 and extending at a first end in a first radial direction. A second radially extending flange 34 is provided at a distance along the driver 30 from the first radially extending flange 32. An intermediate spiral groove 36 is provided on the outer portion of the driver 30 that extends between the first flange 32 and the second flange 34. Furthermore, the partial nut 40 is provided in engagement with the intermediate helical groove 36 so that the partial nut 40 does not rotate with respect to the housing but can move axially with respect to the housing 4. Splined to The spiral groove extends along the entire internal surface of the driver 30. The second spiral groove 24 (male spiral groove) of the spindle 20 is adapted to work in the spiral groove in the driver.
The shoulder 37 is formed between the second end of the driver 30 (proximal end of the driver 30) and an extension 38 provided to the second end of the driver 30. The extension 38 has a smaller inner diameter and profile compared to the rest of the driver 30. The second end of the extension 38 is provided with a flange 39 directed radially outward. FIG. 13 illustrates an enlarged view of the driver 30 and spindle 20 illustrated in FIGS.
A clutch 60 is placed adjacent to the second end of the driver 30. The clutch 60 is generally cylindrical and is provided with a series of circumferentially oriented saw teeth 66 (see, eg, FIG. 7) at a first end (distal end). Each of the saw teeth includes a longitudinally oriented surface and an inclined surface. A flange 62 is placed toward the second end 64 (proximal end) of the clutch 60. The flange 62 of the clutch 60 is arranged between the shoulder 37 of the driver 30 and the flange 39 facing radially outward of the extension 38.
The second end of the clutch 60 is provided with a plurality of dog teeth 65 (see, for example, FIG. 8). The clutch 60 is keyed to the driver 30 via a spline (not shown) to prevent relative rotation between the clutch 60 and the driver 30. In one preferred arrangement, the clicker 50 is provided with the clicker and clutch 60 each extending to approximately half the length of the driver 30. For example, as shown in FIGS. 6 and 7, clicker 50 and clutch 60 are engaged.
The dose dial sleeve 70 is provided outside the clicker 50 and the clutch 60 and radially inside the main housing 4. The dose dial sleeve 70 includes a distal end and a proximal end. A helical groove 74 is provided around the outer surface of the dose dial sleeve 70. The main housing 4 is provided with a window 44 through which a portion of the outer surface of the dose dial sleeve 70 can be seen.
The main housing 4 is further provided with a helical rib 46 adapted to sit in a helical groove 74 on the outer surface of the dose dial sleeve 70. In one preferred arrangement, the spiral ribs 46 extend against a single sweep of the inner surface of the main housing 4. The first stop is provided between the spline 42 and the spiral rib. The second stop portion arranged at an angle of 180 degrees with respect to the first stop portion is formed by a frame surrounding the window 44 in the main housing 4.
Returning to FIGS. 1-5, the dose dial grip 76 is arranged around the outer surface of the second end of the dose dial sleeve 70. The outer diameter of the dose dial grip 76 preferably corresponds to the outer shape of the main housing 4. A dose dial grip 76 is secured to the dose dial sleeve 70 to prevent relative movement between these two parts. The dose dial grip 76 is provided with a central opening 78. An annular recess 80 located at the second end of the dose dial grip 76 extends around the opening 78. Generally, a “T” cross section button 82 is provided at the second end of the device. The button stem 84 extends through the opening 78 in the dose dial grip 76, through the inner diameter of the extension 38 of the driver 30, and into the receiving recess 26 at the proximal end of the spindle 20. The stem 84 is held for limited axial movement in the driver 30 and against rotation relative thereto. The head 85 of the button 82 is generally circular. The skirt 86 extends from the periphery of the head 85. The skirt 86 is adapted to sit in the annular 10 recess 80 of the dose dial grip 76.
The operation of the drug delivery device will be described with reference to FIGS. 9, 10 and 11, arrows A, B, C, D, E, F and G indicate that button 82, dose dial grip 76, dose dial sleeve 70, driver 30, clutch 60, clicker in one arrangement. 50 and the movement of the partial nut 40 are shown.
To dial a dose in the arrangement illustrated in FIG. 9, the user rotates the dose dial grip 76 (arrow B). With the clicker 50 and clutch 60 engaged, the driver 30, clicker 50, clutch 60, and dose dial sleeve 70 rotate using the dose dial grip 76. Torque is transmitted through saw teeth 55, 66 between clicker 50 and clutch 60. The flexible arm 52 deforms and drags the toothed member 54 across the spline 42 to produce a click. Preferably, the splines 42 are arranged so that each click corresponds to a conventional unit dose or the like.
The spiral groove 74 on the dose dial sleeve 70 and the spiral groove in the driver 30 have the same lead. This allows the dose dial sleeve 70 (arrow C) to extend away from the main housing 4 (see also FIG. 15). In this way, the driver 30 (arrow D) climbs the spindle 20 at the same speed. At the limit of travel, a radial stop 104 (see, eg, FIG. 12) on the dose dial sleeve 70 is used as a first stop or second stop provided on the main housing 4 to prevent further movement. Engage with one of the two stops. Due to the overhauled and driven screw on the spindle 20 being in the opposite direction, rotation of the spindle 20 is prevented. The partial nut 40 locked to the main housing 4 is advanced along the intermediate spiral groove 36 by the rotation of the driver 30 (arrow D).
As described above, the first spiral groove form 19 extends from the first end or distal end of the spindle 20 toward the proximal end. This first spiral groove form 19 extends approximately half the length of the spindle 20. The spindle 20 is generally circular in cross section, but other arrangements can be used. The distal end of the spindle 20 is threaded through the insert 16 through the threaded opening 18. The pressure plate 22 is placed at the first or distal end of the spindle 20 and is arranged to be adjacent to the second end of the cartridge piston 10.
The second helical groove form 24 extends from the proximal end of the spindle 20. As shown, the second helical groove form 24 includes a series of partial male helical grooves rather than a full helical groove form. The driver 30 includes an internal spiral groove that extends along the internal surface of the driver 30. As shown, this internal spiral groove extends along the entire internal surface of the driver from the distal end to the proximal end of the driver 30. The second male spiral groove configuration 24 of the spindle 20 is adapted to work in this spiral groove.
Although the arrangement of spindle 20 and driver 30 illustrated in FIGS. 1-13 has certain advantages as described and discussed in US Pat. Has certain limitations. For example, machining spindles and drivers presents certain manufacturing challenges. As described above, this prior art design includes a spindle 20 having two opposing groove configurations 19,24. The first groove form 19 is a female groove form, and this female groove form mates with a cylindrical outer threaded insert 16 of the main outer diameter. The second groove form 24 includes a plurality of male protrusions that engage a continuous groove in the driver 30.
This continuous groove is formed along the entire length of the inner surface of the driver 30.
In this prior art drug delivery device, during dose setting, when the driver 30 is rotated relative to the spindle 20, the driver is coupled with a number sleeve threaded into the housing, so that the driver 30 Moves axially. The axial distance moved by the driver 30 will depend on the pitch of the number sleeve 74, which is generally similar to the pitch of the continuous internal grooves on the driver 30. Therefore, the arrangement of the conventional surgical spindle 20 and the driver 30 requires that the inner spiral groove be provided to the driver 30 over substantially the entire inner surface of the driver 30. In this arrangement, the driver 30 is not disengaged from the spindle helical groove 24 either during the dose setting process or during the dose administration process.
This arrangement thus provides certain design and fabrication challenges. For example, during the molding of the driver 30, and in particular during the molding process of the internal spiral groove of the driver 30, during the process of removing the molded product from the injection molding machine, this process involves the threaded core pin being removed from the driver. Request to spin out. This processing step has disadvantages. For example, the rotation of a threaded core pin is a complex gear in a molding jig with a flexible water cooling tube or a sealed rotating joint that is required so that the rotating core pin can be cooled. Request mechanism. Rotating the core increases jig cycle time, and generally adds jig complexity and increased maintenance costs.
Thus, these issues are considered in the design and development of spindles for certain drug delivery devices, such as reusable (ie resettable) or disposable (ie non-resetable) drug delivery devices. There is a general need to do.
WO 2004/078293
It is an object of the present invention to provide an improved dose setting mechanism suitable for reusable (ie resettable) or disposable (ie non-resettable) drug delivery devices.
This object is solved by a spindle as defined in claim 1. The spindle according to the invention has two overlapping spiral grooves. One of the grooves may be connected to or engaged with a driver so that when the user sets the dose by rotating a rotating sleeve (such as a dose dial sleeve), the driver also rotates. . The other of the grooves can be coupled to or engaged with a portion (such as an inner or outer housing) of the drug delivery device body. Preferably, the spindle is manufactured using a simple opening / closing (molding) jig that does not have a threaded core pin.
According to an exemplary embodiment, the spindle for driving the cartridge plug includes a generally circular shaft having an outer surface. In general, a circular shaft extends from the distal end to the proximal end of the circular shaft. The first spiral groove is provided along a first portion of the outer surface. The first spiral groove has a first pitch. The second spiral groove is provided along a second portion of the outer surface of the generally circular shaft. The second spiral groove overlaps the first spiral groove. The second spiral groove has a second pitch.
The first spiral groove of the spindle may be a spiral female groove. Furthermore, the second spiral groove may be a spiral female groove. Also, the first spiral groove and / or the second spiral groove extends from approximately the distal end of the spindle to approximately the proximal end of the spindle along the outer surface of the shaft.
To interact with the spindle, the dose setting mechanism is provided with a driver for driving the spindle and / or a drug delivery body (such as a housing). The driver can include a helical groove configuration that engages the first helical groove of the spindle, and the drug delivery body can include a helical groove configuration that engages the second helical groove of the spindle. Preferably, the helical groove on the driver and / or on the drug delivery body comprises a partial groove form, such as less than a single helical groove. The spiral groove on the driver and / or the spiral groove on the drug delivery body can be designed as a male spiral groove.
In another arrangement, a dose setting mechanism is provided for use with the drug delivery device. The mechanism includes a housing and a rotating sleeve that is in rotatable engagement with the housing. The driver is releasably connected to the rotating sleeve. A spindle with two overlapping helical grooves is connected to the driver in an effective manner so that when the user sets the dose by rotating the rotating sleeve, the driver also rotates.
The dose setting mechanism having a spindle according to the present invention may be a resettable dose setting mechanism, wherein the driver includes a first part and a second part, where the user sets the dose. When doing so, they are connected together in an effective manner so that the first and second parts rotate together. Further, when the user resets the dose setting mechanism and the first part rotates back to its original position, the dose limiting device can return to the initial position.
It is further preferred to provide a cartridge holder releasably connected to the dose setting mechanism. This can be achieved via a bayonet connection. The cartridge holder typically includes a removable cartridge.
These as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings.
Exemplary embodiments will now be described with reference to the drawings:
1 illustrates a cross-sectional view of a first embodiment of a known drug delivery device in a first, cartridge full position. FIG. FIG. 2 illustrates a cross-sectional view of the drug delivery device of FIG. 1 in a second, maximum first dose dialed position. FIG. 3 illustrates a cross-sectional view of the drug delivery device of FIG. 1 in a third, maximum first dose administered position. FIG. 4 illustrates a cross-sectional view of the drug delivery device of FIG. 1 in a fourth, final dose dialed position. FIG. 6 illustrates a cross-sectional view of the drug delivery device of FIG. 1 in a fifth, final dose administered position. FIG. 2 illustrates a cross-sectional view of a first detail of the drug delivery device of FIG. FIG. 2 illustrates a partial cross-sectional view of a second detail of the drug delivery device of FIG. FIG. 4 illustrates a partial cross-sectional view of a third detail of the drug delivery device of FIG. FIG. 2 illustrates the first relative movement of the portion of the drug delivery device shown in FIG. 1 during a dose escalation. 2 illustrates the relative movement of the portion of the drug delivery device shown in FIG. 1 during dose reduction. 2 illustrates the relative movement of the portion of the drug delivery device shown in FIG. 1 during administration of a dose. FIG. 4 illustrates a partial cross-sectional view of the drug delivery device of FIG. 1 in a second, maximum first dose dialed position. FIG. 3 illustrates a cross-sectional view of the spindle and driver illustrated in FIGS. Figure 3 illustrates the placement of a drug delivery device. FIG. 15 illustrates the drug delivery device of FIG. 14 with the cap removed. FIG. 16 illustrates a cross-sectional view of a first arrangement of the drug delivery device of FIG. 15 in a first position. FIG. 16 illustrates a cross-sectional view of a first arrangement of the drug delivery device of FIG. 15 in a second position. FIG. 16 illustrates a cross-sectional view of a first arrangement of the drug delivery device of FIG. 15 in a third position. FIG. 19 illustrates a first arrangement of the drivers illustrated in FIGS. 16-18, including a first driver portion and a second driver portion. FIG. 19 illustrates the distal end of the spindle of the dose setting mechanism illustrated in FIGS. FIG. 15 illustrates a cross-sectional view of a second arrangement of the dose setting mechanism of the drug delivery device illustrated in FIG. 14. FIG. 22 illustrates a partial cross-sectional view of a second arrangement of the dose setting mechanism illustrated in FIG. FIG. 22 illustrates an enlarged view of Gap “a” illustrated in FIG. 21. Fig. 3 illustrates a second arrangement of drivers including a first driver portion and a second driver portion. 9 illustrates the dose setting mechanism illustrated in either FIGS. 2-5 or FIGS. FIG. 26 illustrates the dose setting mechanism illustrated in FIG. 25 where the user has already set the dose. FIG. 16 illustrates a driver that may be used with the dose setting mechanism of the drug delivery device illustrated in FIGS. Fig. 28 illustrates a spindle connected to the driver illustrated in Fig. 27; Fig. 4 illustrates an enlarged view of a spindle according to the present invention that can be used with a dose setting mechanism of a drug delivery device.
As used herein, the term “drug” or “medicament” or “medicament” means a pharmaceutical formulation comprising at least one pharmaceutically active compound,
Here, in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and / or a peptide, protein, polysaccharide, vaccine, DNA, RNA, antibody, enzyme, antibody, hormone or An oligonucleotide or a mixture of the above-mentioned pharmaceutically active compounds,
Here, in a further embodiment, the pharmaceutically active compound comprises at least one human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), or an analog or derivative thereof, or exedin- 3 or exedin-4, or an analog or derivative of exedin-3 or exedin-4.
Exendin-4 is, for example, exendin-4 (1-39), 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-NH 2 Means peptide.
H- (Lys) 4-desPro36, desPro37 exendin -4 (1-39) -NH 2,
H- (Lys) 5-desPro36, desPro37 exendin -4 (1-39) -NH 2,
desPro36 [Met (O) 14, IsoAsp28] Exendin-4 (1-39),
desPro36 [Met (O) 14Trp (O2) 25, Asp28] exendin-4 (1-39),
Or an exendin-4 derivative of the following sequence;
H- (Lys) 6-desPro36 [ Asp28] Exendin -4 (1-39) -Lys6-NH 2 ,
desAsp28, Pro36, Pro37, Pro38 exendin -4 (1-39) -NH 2,
H- (Lys) 6-desPro36, Pro38 [Asp28] Exendin -4 (1-39) -NH 2,
H-Asn- (Glu) 5desPro36, Pro37, Pro38 [Asp28] exendin-4 (1-39) -NH 2 ,
desPro36, Pro37, Pro38 [Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H- (Lys) 6-desPro36 [ Trp (O2) 25, Asp28] Exendin -4 (1-39) -Lys6-NH 2 ,
H-desAsp28 Pro36, Pro37, Pro38 [Trp (O2) 25] Exendin -4 (1-39) -NH 2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) -NH 2,
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Trp ( O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H- (Lys) 6-des Pro36 , Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H- (Lys) 6-desPro36 [Met (O) 14, Asp28] exendin-4 (1-39) -Lys6-NH 2 ,
desMet (O) 14, Asp28, Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH 2 ,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) -NH 2,
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Met (O) 14, Asp28] exendin-4 (1-39)-(Lys) 6-NH 2 ,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H-Asn- (Glu) 5, desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H-Lys6-desPro36 [Met ( O) 14, Trp (O2) 25, Asp28] Exendin -4 (1-39) -Lys6-NH 2 ,
H-desAsp28, Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] Exendin -4 (1-39) -NH 2,
H- (Lys) 6-des Pro36 , Pro37, Pro38 [Met (O) 14, Asp28] Exendin -4 (1-39) -NH 2,
H-Asn- (Glu) 5- desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin -4 (1-39) -NH 2,
desPro36, Pro37, Pro38 [Met ( O) 14, Trp (O2) 25, Asp28] Exendin -4 (1-39) - (Lys) 6-NH 2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin -4 (S1-39) - (Lys) 6-NH 2,
Hormones include, for example, gonadotropin (holitropin, lutropin, corion gonadotropin, menotropin), somatropin (somatropin), desmopressin, telluripressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin, etc., Rote Liste, 2008 Pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists as indicated in the chapter.
Polysaccharides include, for example, glucoaminoglycans such as hyaluronic acid, heparin, low molecular weight heparin, or ultra low molecular weight heparin, or derivatives thereof, or sulfonated, for example, polysulfonated forms of the aforementioned polysaccharides, Or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of polysulfonated low molecular weight heparin is enoxaparin sodium salt.
Pharmaceutically acceptable salts include, for example, acid addition salts and base salts. Examples of acid addition salts include HCl or HBr salts. The base salt is, for example, a cation selected from an alkali or alkaline earth metal, such as Na + , K + , or Ca 2+ , or an ammonium ion N + (R1) (R2) (R3) ( R4), wherein R1 to R4 are, independently of one another, hydrogen; an optionally substituted C1-C6 alkyl group; an optionally substituted C2-C6 alkenyl group; an optionally substituted C6- A C10 aryl group or an optionally substituted C6-C10 heteroaryl group. Additional examples of pharmaceutically acceptable salts can be found in “Remington's Pharmaceutical Sciences”, 17th edition, Alfonso R. Gennaro (Editor), Mark.
Referring to FIG. 14, there is shown a drug delivery device 201 according to the first arrangement of the present invention in an inventor's double helix spindle and driver configuration. In this arrangement, the drug delivery device 201 may include either a resettable or non-resetable drug delivery device.
The drug delivery device 201 includes a housing having a first cartridge holder 202 and a dose setting mechanism 204. The first end of the cartridge holding means 202 and the second end of the dose setting mechanism 204 are fixed together by a holding mechanism. In this illustrated arrangement, the cartridge holding means 202 is secured within the second end of the dose setting mechanism 204. A removable cap 203 is releasably held over the second or distal end of the cartridge holder. As will be described in more detail below, the dose setting mechanism 204 includes a dose dial grip 212 and a window or lens 214. To set the dose of the drug contained within the drug delivery device 201, the user rotates the dose dial grip 212 and the window allows the user to view the dialed dose via the dose scale arrangement 216. Is possible.
FIG. 15 illustrates the drug delivery device 201 of FIG. 14 with the cover 203 removed from the distal end of the drug delivery device. As shown, a cartridge 220 from which multiple doses of medication can be dispensed is provided in a dose setting mechanism housing 206. Preferably, cartridge 220 contains the type of drug that must be administered often, such as once or more times a day. One such drug is insulin. A stopper or stopper (not illustrated in FIG. 14) is retained at the first or proximal end of the cartridge 220.
As described above, the dose setting mechanism 204 of the drug delivery device illustrated in FIG. 14 can be utilized as a reusable (and hence resettable) drug delivery device. Alternatively, the dose setting mechanism 204 of the drug delivery device illustrated in FIG. 14 can be utilized as a non-reusable (and therefore non-resetable) drug delivery device.
The cartridge is removable from the cartridge housing 206 when the drug delivery device 201 includes a reusable drug delivery device. The cartridge 220 can be removed from the device by simply detaching the dose setting mechanism 4 from the cartridge holder 220 by the user without destroying the device.
In use, once the removable cap 203 is removed, the user can attach a suitable needle assembly to the distal end of the cartridge holder. Such a needle unit can be screwed onto the distal end of the housing or alternatively can be snapped onto this distal end. A replaceable cap 203 is used to cover the cartridge holder 206 extending from the dose setting mechanism 204. Preferably, the external dimensions of the replaceable cap 203 are the same as the external dimensions of the dose setting mechanism 4 so as to provide an overall impression of the monolith when the replaceable cap 203 is in a position covering the cartridge holder 202. Similar or equal.
FIG. 16 illustrates a cross-sectional view of the dose setting mechanism 204 removably coupled to the cartridge holder 206. The dose setting mechanism 204 includes an outer housing 240 that houses a spindle 242, a number sleeve 210, a clutch 226, and a driver 230. As will be described in more detail below, the spindle preferably includes a first groove 219 and a second groove 221 that overlaps the first groove 219. The first spiral groove 219 extends from the first end of the spindle 242. In one arrangement, the spindle 242 has a generally circular cross section, although other arrangements can be used. The first end (distal end 243) of the spindle 242 extends through the pressure plate 264. The spindle bearing 250 is placed at the distal end 243 of the spindle 242. The spindle bearing 250 is arranged adjacent to the second end of the cartridge piston 218. The driver 230 extends near the spindle 242.
The clutch 226 is arranged near the driver 230 and between the driver 230 and the number sleeve 224. The clutch 226 is placed adjacent to the second end of the driver 230. The number sleeve 224 is provided outside the clutch 226 and radially inward of the outer housing 240. The main housing 204 is provided with a window 214 through which a portion of the outer surface 211 of the number sleeve 224/210 can be viewed.
Returning to FIGS. 14-15, the dose dial grip 212 is arranged near the outer surface of the second end of the number sleeve 10. The outer diameter of the dose dial grip 212 preferably corresponds to the outer diameter of the housing 240. A dose dial grip 212 is secured to the number sleeve 210 to prevent relative movement between the two parts. In one preferred arrangement, the dose dial grip 212 and button 205 include a unitary piece with a clutch and drive sleeve rotationally connected and axially connected to the number sleeve 210. However, alternative coupling arrangements can also be used.
As shown in FIGS. 16-18, in this arrangement, the driver 230 includes a first driver portion 244 and a second driver portion 246 and these portions extend around the spindle 242. Both the first and second driver portions 244, 246 are generally cylindrical. As seen from FIG. 19, the first driver portion 244 is provided at a first end having a first flange 256 extending radially. A radially extending second flange 258 is provided at a distance from the first flange 256 along the first driver portion 244. An intermediate spiral groove 262 is provided on the outer portion of the first driver portion 244 that extends between the first flange 256 and the second flange 258. A partial or partial helical groove 268 extends along the inner surface of the first driver portion 244. One of the overlapping grooves 219, 221 of the spindle 242 is adapted to work in this partial helical groove 268.
A dose limiter 238 (shown in FIG. 16) is placed between the driver 230 and the housing 4 and is arranged between the first flange 256 and the second second flange 258. In the illustrated arrangement, the dose limiter 238 has a nut. The dose limiter 238 has an internal spiral groove that matches the spiral groove 262 of the driver 230. In one preferred arrangement, the outer surface of dose limiter 238 and the inner surface of housing 240 are keyed together via a spline. This prevents relative rotation between the dose limiter 238 and the housing 240, while allowing for relative longitudinal movement between the two parts.
Referring back to FIGS. 15-18, in essentially normal use, operation of the dose setting mechanism 204 occurs as follows. To dial a dose in the arrangement illustrated in FIGS. 14-18, the user rotates the dose dial grip 12. The driver 230, the clutch 226 and the number sleeve 210 rotate with the dose dial grip 212.
The number sleeve 210/224 extends proximally away from the housing 240. In this way, the driver 230 essentially climbs one of the grooves 219, 221 provided along the surface of the spindle 242. At the travel limit, the radial stop of the number sleeve 210 engages either the first stop or the second stop provided on the housing 240 to prevent further movement. To do. The rotation of the spindle 242 is prevented because the overhauled and driven threads on the spindle 242 are in the opposite direction. In this arrangement, the dose limiter 238 locked to the housing 240 is advanced along the thread 262 by rotation of the driver 230.
FIG. 15 illustrates a preferred arrangement of Applicant's drug delivery device after the desired dose has been dialed. In this description, the desired dose of 79 international units (“IU”) was dialed. When this desired dose has been dialed, the user can then administer the desired dose of 79 IU by depressing the dial grip 212. As the user depresses the dial grip 212, this causes the clutch 226 to move axially relative to the number sleeve 210 and disengage the clutch 226 from the number sleeve 210. However, the clutch 226 remains locked in rotation with respect to the driver 230. The number sleeve 210 rotates freely here.
In this illustrated arrangement, the driver 230 is prevented from rotating relative to the main housing 204. However, the driver 230 is free to move axially with respect to the main housing 204. The longitudinal movement of the driver 230 causes the spindle 242 to rotate and thereby advance the piston 218 distally through the cartridge 220.
In normal use, when the dose dial sleeve 210 is rotated, the first and second portions 244, 246 of the driver 230 are coupled together. That is, in normal use, the first and second portions 244, 246 of the driver 230 are coupled together with the dose dial sleeve 210 when the user sets the dose by turning the dose dial grip 212. . After each dose administration, the spindle 242 is moved in the distal direction to continue discharging the dialed dose of drug from the needle assembly releasably connected to the distal end 208 of the cartridge holder 206. It is pushed and acts on the plug 218 of the cartridge 220.
After the user has used the drug delivery device 201 to administer all of the medication contained in the cartridge 220, the user may wish to replace the empty cartridge in the cartridge holder 206 with a new cartridge. The user must then also reset the dose setting mechanism 4: for example, the user must then retract or push the spindle 242 back into the dose setting mechanism 204.
If the user decides to replace the empty cartridge and reset the device 201, the first and second driver portions 244, 246 must be disconnected from each other. After the first driver portion 244 is disconnected from the second driver portion 246, the first driver portion 244 will rotate freely while the second driver portion 246 is free to rotate. Will not rotate.
During the device reset process, rotation of the first driver portion 244 achieves at least two results. First, since the spindle 242 is rotated by the rotation of the first driver portion 244, the rotation of the first driver portion 244 resets the axial position of the spindle 242 with respect to the dose setting mechanism 204. Will be done. The rotation of the spindle 242 (because the spindle is threadedly engaged with the snut 266) moves the spindle proximally back into the dose setting mechanism. FIG. 20 also illustrates one arrangement for connecting the spindle 242 to the spindle guide 248. In FIG. 20, the spindle 242 includes a first spline 251 and a second spline 252 defining first and second grooves 219 and 212, respectively. The spindle guide 248 includes an essentially circular member having an opening. The openings protruded into two interiors that engage the first and second splines 251, 252 respectively so that the spindle guide 248 locks onto the spindle and rotates with the spindle during rotation of the spindle. Members 255 and 257 are included.
By rotating the first driver portion 244, the dose limiter 238 will also be axially moved or reset to the initial or starting position. That is, because the dose limiter 238 is threadedly engaged with the outer groove and splined to the inner surface of the housing portion, such as the outer housing 240, the first driver portion 244 is rotated back to the initial starting position. It is. In this configuration, the dose limiter 238 will move along the external groove 262 of the first driver portion 244, while this portion is rotated during the reset process, while preventing rotation.
Referring to the first driver arrangement illustrated in FIG. 16, the two parts of the driver 230 are connected when the first driver part 244 is pulled axially away from the second drive part 246. Canceled. This initially locks the relative rotation between the spindle 242 and the spindle guide 248 through which the spindle passes, and then this spindle guide 248 and nut 266 also push a fixed distance in the axial direction. Thus, it can be achieved by the use of biasing means (such as at least one spring) that interact together when the cartridge holder 206 is removed from the front or distal end of the device. Since the spindle 242 is rotationally locked to this spindle guide 248 and threadedly engaged with the spindle nut 66, the spindle 242 will move axially.
Spindle 242 may be coupled via a groove engaged with first driver portion 44. The first driver portion 244 is prevented from rotating by a clutch connection to the second driver portion 246. In one preferred arrangement, the second driver portion 246 is prevented from rotating by a clicker detent 75 (see FIG. 1). A clicker detent 75 may be present between the clutch and the flange 280 on the second driver portion 246. Thus, the axial movement of the spindle 242 causes the two driver portions 244, 246 to be disengaged so that the clutch is disengaged.
This sequence of operations when the cartridge holder 206 is removed or disconnected from the dose setting mechanism 204 is illustrated in FIGS. In FIG. 16, the various parts of the drug delivery device include: dose setting housing 240, cartridge 220, spindle 204, first driver portion 244; second driver portion 246, spindle bearing 250, spindle guide. 248, spindle plate 254; main spring 260, pressure plate 264, cartridge holder 206; spindle nut 266; and second spring 270. In this preferred arrangement, the spindle guide 248 is rotationally fixed relative to the spindle 242. The spring plate 254, the pressure plate 264, and the spindle nut 266 are rotationally fixed with respect to the outer housing.
In FIG. 16, the cartridge holder 206 fits through an opening in the pressure plate 264 and applies a load to the spring plate 254. As a result, the first biasing means, that is, the main spring 260 is compressed. These openings in the pressure plate 264 (not shown) cause the pressure plate 264 (in the distal direction toward the cartridge holder 206) to spring plate under the action of the second biasing means or second spring 270. It is possible to move away from 254. This will open Gap “a” as shown in FIG. Gap “a” is a gap created between the pressure plate 264 and the spring plate 54. This will also open the gap Gap “b” between the spindle nut 266 and the spring plate 54. This Gap “b” is illustrated in FIG. Gap “b” integrates with the light force from the second spring or biasing means 270 to move the spindle nut 266 toward the distal end of the drug delivery device 201. As a result, a light pressure is applied to the spindle guide 248.
The spindle guide 248 is compressed under the action of the second spring 270 between the spindle nut 266 and the pressure plate 264. This weak force, through which this force is coupled with the coefficient of friction on either side of the flange of the spindle guide 248 on which this force acts, provides resistance to rotation of the spindle guide 248 and thus resistance to rotation of the spindle 242. . One advantage of this configuration is that it is advantageous to prevent the spindle 242 from rolling back into the dose setting mechanism 204 under a light residual load that may remain from the cartridge stopper 218 at the end of the dose. By preventing the spindle 242 from rolling back in the proximal direction, the distal end 243 of the spindle 242 (and thus the spindle bearing 250) remains on the plug 218. Holding the distal end 243 of the spindle 42 on the piston 218 helps prevent the user from administering potentially small doses.
As the user delivers the dose, the dosing force increases so that a backward load on the spindle nut 266 travels back in the proximal direction and compresses the second spring 270. Increase. As a result, the axial force acting on the spindle guide 248 is released. This removes the resistance to rotation of the spindle guide 248 and thus the spindle 242. Thus, this arrangement prevents the spindle 242 from rolling back under the low load created by the cartridge plug 218, but once this dosage is increased above a certain threshold level, there is no addition to this dosage. Not.
FIG. 17 illustrates the dose setting mechanism 4 of FIG. 16 with the cartridge holder 206 rotated to release the connection type between the housing 240 of the dose setting mechanism 204 and the cartridge holder 206. In one arrangement, the connection type 222 is a bayonet connection. However, those skilled in the art will recognize that other connection types 22 such as screws, snap locks, snap fits, luer locks and other similar connection types may be used as well. 16-18, in the pressure plate 264 by rotating the cartridge holder 206 relative to the housing 240 so that they now release this force created by the main biasing means 260. In order to compress the main biasing means 260 through the opening, the mechanism initially acting on the spring plate 254 rotates. This allows the spring plate 54 to move distally until the spring plate 254 contacts the spindle nut 266 on the inner surface of the spindle nut 266.
In this second state, the previously discussed Gap “a” (from FIG. 16) is now reduced to Gap “c” (as seen in FIG. 17). In this way, a relatively large axial force from the main biasing means 260 acts on the spindle nut 266 through the spring plate 254 and acts on the pressure plate 264 from the spindle nut 266 through the spindle guide 248. This relatively large axial force from the main biasing means 260 is sufficient to prevent the spindle guide 248 and thus the spindle 42 from rotating.
After full rotation of the cartridge holder 206, the cartridge holder 206 disengages from the connection type 222 with the housing 240. The cartridge holder 206 is then driven axially (ie, distally) away from the housing 240 by the main biasing means 260. However, during this movement, the main biasing means 260 continues to load the cartridge holder 206 through the spindle guide 248 so that the spindle 242 is prevented from rotating. Since the spindle 242 is also threaded into the first driver portion 244, the first driver portion 244 is also pulled axially distally and thus from the second driver portion 246. The engagement is released. The second driver portion 246 is axially fixed and prevented from rotating. In one arrangement, the second driver portion 246 is prevented from rotating by the clicker element and is prevented from moving axially by its axial connection to the number sleeve.
FIG. 18 illustrates the dose setting mechanism illustrated in FIG. 16 in a third position, ie, with the cartridge holder 206 removed. Since the cartridge holder 206 is removed from the housing 240, the bayonet mechanism shown in FIG. 18 (shown as a round pile extending radially inward on the inside of the inner housing) causes the pressure plate 64 to travel. Although limited, Gap “c” (as shown in FIG. 17) can become larger (as shown in FIG. 18) to a wider Gap “d”. As a result, Gap “e” is generated. Gap “e” causes the large spring force created by the main biasing means 260 to be removed from the spindle guide 248. The dose setting mechanism 204 in FIG. 17 is now ready to be reset.
To reset the dose setting mechanism 204, the user pushes the distal end 243 of the spindle 242 back to retract the spindle 242 proximally into the housing 240. Thus, during this resetting process of the dose setting mechanism 204, the spindle 242 is pushed back into the dose setting mechanism 204 so that the movement of the spindle 242 resists the light spring force created by the second biasing means 270. The nut 266 will be moved back. This movement releases the axial load and thus the rotational resistance from the spindle guide 248. Accordingly, since the dose setting mechanism 204 is reset by the spindle 242 rotating back into the dose setting mechanism 204, the spindle guide 248 also rotates.
As the spindle 242 is further pushed back into the dose setting mechanism 204, the spindle 242 rotates through the spindle nut 266 through one of the helical grooves provided along the surface of the spindle 242. Since the first driver portion 244 is decoupled from the second driver portion 246, the first driver portion 244 is (the first annular ring on the second half of the second driver portion 246). The flexible elements 302, 303 run on the conical surface groove 290 formed by 291; see FIGS. 16 and 17). This accommodates the axial and rotational movement of the spindle 242.
As the first driver portion 244 rotates during reset, the first driver portion 244 also resets the dose nut. More specifically, as the first driver portion 244 rotates, a dose nut that cannot rotate because it is splined to the inner surface of the housing 240 is provided along the outer surface of the first driver portion 244. Traverses along the spiral groove 262 and back across to the initial or starting position. In one preferred arrangement, this starting position of the dose nut is along the first radial flange 256 of the first driver portion 244.
After the dose setting mechanism 204 is reset, the dose setting mechanism 204 must be reconnected to the cartridge holder 206. When reconnecting these two parts, the method generally works in reverse. This time, however, the axial compression of the main spring 260 causes the first driver portion 244 to re-engage with the second driver portion 246. In this way, the flexible element re-engages with the second annular ring 294 on the second driver portion 246.
FIG. 19 illustrates a first arrangement of the second driver portion 246 and the first driver portion 244 illustrated in FIG. As shown in FIG. 19, the second driver portion 246 has a generally tubular shape and includes a first annular ring 290 at the distal end of the second driver portion 246. . The first annular ring 290 includes a conical surface 291. The second driver portion further includes a second annular ring 294 and at least one spline 296 positioned along the surface of the second driver portion.
The first driver portion 244 is also generally tubular in shape and includes first and second flexible elements 302, 303 and a plurality of number sleeves 300. The plurality of recesses 300 are configured so that when both the first and second driver portions 244, 246 are pushed together axially so that they are releasably engaged with each other, the first driver portion 244 longitudinal splines 296 are releasably coupled to the second driver portion 46. When pushed together, the flexible elements 302, 303 of the first driver portion 244 are pushed across the first annular ring 290 of the second driver portion 246 and then the second driver It stops when the flange 280 of the portion is adjacent to the first shaft flange 256 of the first driver portion 244.
The first driver portion 244 also includes a plurality of ratchet mechanisms 304. These ratchet mechanisms 304 are provided at the distal end 306 of the first driver portion 244. These ratchet mechanisms 304 engage a similar ratchet mechanism on a spring plate 254 that is splined into the housing 240 (see FIGS. 16-18). At the end of the reset process, these ratchet mechanisms engage each other to prevent the first driver portion 244 from rotating. This causes the first driver portion to move axially to re-engage with the second driver portion 246 rather than rotating on the conical surface 290 when the spindle 242 is further reset. Is secured. These mechanisms also orient the spring plate 254 against the second driver portion 244 so that the two driver portions 244, 246 are easily engaged during assembly or after reset. Therefore, these ratchet mechanisms also prevent the coupling mechanisms 300, 296 from colliding with each other.
As described above, the first driver portion 244 also includes a helical groove 268. This helical member, preferably a partial helical member, contains less than one turn of the helix and engages helical grooves 219, 221 provided along the spindle 242. Through this engagement, the driver portion 244 can rotate during the dose setting process, while the spindle does not rotate during this process.
A second arrangement of resettable dose setting mechanism is illustrated in FIGS. FIG. 21 illustrates a cross-sectional view of a second arrangement of the dose setting mechanism 400. One skilled in the art will recognize that the dose setting mechanism 400 may include a coupling mechanism for releasably coupling to a cartridge holder, such as the cartridge holder 206 illustrated in FIG. FIG. 22 illustrates the portion of the dose setting mechanism illustrating the operation of the driver. FIG. 23 illustrates an enlarged view of the connection between the first driver portion and the second driver portion illustrated in FIG. The second arrangement of dose setting mechanism 400 operates in a manner generally similar to the first arrangement of dose setting mechanism 204 illustrated in FIGS.
With reference to FIGS. 21-23, the dose setting mechanism 400 includes a dose dial grip 402, a spring 401, a housing 404, a clutch 405, a number sleeve 406, and an inner housing 408. Similar to the driver 230 illustrated in FIGS. 15-18, the dose setting mechanism driver 409 includes a first driver portion 407 and a second driver portion 412. In one arrangement, the first driver portion 407 includes a first component portion 410 and a second driver portion 412. Alternatively, the first driver part 407 is an integrated part part.
As illustrated in FIGS. 21 and 22, the driver 409 is when the first driver portion 407 is pushed axially toward the second driver portion 412 (ie, when pushed proximally). The connection is released from the dose setting mechanism 400. In one arrangement, this is accomplished by pushing axially on the distal end of the spindle 414. This does not require any mechanism associated with removal of the cartridge holder. This mechanism is also designed so that the first and second driver portions 407, 412 and spindle 414 remain rotationally locked together during dose setting and during dose administration.
The axial force on the spindle 414 causes the spindle 414 to rotate due to its threaded connection to the inner housing 408. This rotation and axial movement of the spindle 414 in turn causes the first driver portion 407 to move axially toward the second driver portion 412. This will eventually disconnect the connecting element 450 between the first driver portion 407 and the second driver portion 412. This can be seen from FIGS.
This axial movement of the first driver portion 407 towards the second driver portion 412 provides certain advantages. For example, one advantage is that the metal spring 401 will compress and thus close the Gap “a” illustrated in FIGS. This in turn prevents the clutch 405 from disengaging from the clicker 420 or from the number sleeve 406. The second driver 412 is prevented from rotating because it is splined into the clutch 405. Clicker 420 is splined relative to inner housing 404 or inner housing 408. Accordingly, the second driver portion 412 cannot rotate relative to the housing 404 or number sleeve 406 when the gap “a” is reduced or enlarged. As a result, the number sleeve 406 cannot rotate with respect to the housing 404. If the number sleeve 406 is prevented from rotating, then the spindle 414 is retracted back into the dose setting mechanism 400 and reset by doing so, resulting in the force being put on the spindle 414 resulting in a number sleeve. There would be no risk that 406 would be pushed from the proximal side of the dose setting mechanism 400.
Similarly, when the drug delivery device is administered, the user applies an axial load to the dose button 416. The dose button 416 is axially coupled to the clutch 405 and thereby prevents relative axial movement. Accordingly, the clutch 405 moves axially toward the cartridge end or the distal end of the dose setting mechanism 400. This movement disengages the clutch 405 from the number sleeve 406 and allows relative rotation while enlarging the gap “a”.
As described above, this prevents the clutch 405 from rotating relative to the clicker 420 and thus relative to the housing 404. However, in this aspect, it also prevents the connection between the first driver portion 407 and the second driver portion 412 from being disengaged. Thus, any axial load on the spindle 414 will disengage the first and second driver portions 407, 412 only when the dose button 416 is not loaded axially. This therefore does not occur during administration.
Using the dose setting mechanism 400, when a user dials a dose with the dose dial grip 402, the metal spring 401 is selected to be strong enough to maintain the engagement of both clutch connections: Clutch connection between 40 and 5 number sleeve 406 and clutch connection between first driver portion 407 and second driver portion 412.
FIG. 24 shows details of the first arrangement of the first driver portion 407 and the second driver portion 412 illustrated in FIG. As illustrated in FIG. 24, the second driver portion 412 has a generally tubular shape and at least one drive dog 450 positioned at the distal end of the second driver portion 412. including. The first driver portion 407 is also generally tubular in shape and includes a plurality of recesses 452 sized to engage the drive dog 450 on the second driver portion 412. The construction of the drive dog and recess allows disengagement with the drive dog 450 when the first and second driver portions are pushed together in the axial direction. This construction also creates a rotational connection when these parts are flipped away. A dose limiter 418 is provided on the first driver portion 407 and operates similarly to the dose limiter 128 illustrated in FIG.
In this arrangement, the first driver portion 407 includes a first portion (first component portion) 411 that is permanently clipped to a second portion (second component portion) 410. In this arrangement, the first portion 411 includes a drive dog 452 and the second portion 410 includes an outer groove for the last dose nut 418, as well as the inner groove 454. This internal groove 454 is used to join the spindle 414 and drives the spindle 414 during dose administration.
In the illustrated arrangement, the inner groove 454 includes a partial spiral groove rather than a full spiral groove. One advantage of this arrangement is that it is generally easier to manufacture.
As can be seen from the arrangement illustrated in FIGS. 21-22, in addition, there are certain mechanism enhancements that span the dose setting mechanism 204 illustrated in FIGS. These can be added independent of the ability to reset the device to replace an empty cartridge with a new cartridge. These enhancements are therefore relevant to both dose setting mechanisms that can and cannot be reset.
One advantage of both the illustrated arrangements, and in particular the arrangements illustrated in FIGS. 21-22, is that the dose setting mechanism 400 has fewer parts than other known dose setting mechanisms. Also, apart from the metal coil spring 401, all of these components that make up the dose setting mechanism 400 can be injection molded using an inexpensive and uncomplicated jig. By way of example only, these parts that make up the dose setting mechanism 400 may be injection molded without the use of expensive and complex rotating cores.
Another advantage of the dose setting mechanism 400 including the inner housing 408 is that the dose setting mechanism 400 can be designed as a drug delivery device platform that can support both resettable and non-resettable dose setting mechanisms with minor modifications. That is. By way of example only, first driver portions 411 and 410 and second driver portion 412 may be modified to modify a non-resetable drug delivery device of the resettable dose setting mechanism 400 variation illustrated in FIGS. Can be molded as an integral part. This reduces the total number of drug delivery device components by two. Alternatively, the drug delivery device illustrated in FIGS. 21-22 could be left unchanged. In such a disposable device, the cartridge holder may be fixed to the housing or may be made as a unitary body and cartridge holder.
The illustrations in FIGS. 21-22 show an inner housing 408 having a length “L” 430 that is generally similar in overall length to the dose setting mechanism 400. As will be described later, providing an inner housing 408 having a length “L” 430 provides other well-known methods that do not utilize an inner body or an inner body having a length generally equal to the length of the dose setting mechanism. There are many advantages over dose setting mechanisms.
Inner housing 408 includes a groove 432 provided along an outer surface 434 of the inner housing. A groove guide 436 provided on the inner surface 438 of the number sleeve 406 is rotatably engaged in this groove 432.
One advantage of this dose setting mechanism 400 utilizing the inner housing 408 is that the inner housing 408 can be made of engineering plastic that minimizes friction against the number sleeve 406, groove guide 436 and groove 432. For example, one such engineering plastic would include acetal. However, those skilled in the art will recognize that other equivalent engineering plastics having a low coefficient of friction could also be used. By using such engineering plastics, the material for the outer housing 404 is selected for aesthetic or tactile reasons rather than friction requirements, because the outer housing 404 does not engage any moving parts during normal operation. Can be done.
Rather than providing such a spiral groove on the outer surface 440 of the number sleeve 406, the inner housing 408 can also be provided with a number sleeve 406 having a spiral groove on the inner surface 438 of the number sleeve 406. To do. Providing such an internal groove provides many advantages. For example, this provides the advantage that a larger surface area is provided along the outer surface 440 of the number sleeve 406 to provide a scale arrangement 442. The larger surface area of the number sleeve can be used for drug or device identification purposes. Another advantage of providing a spiral groove 436 on the inner surface 438 of the number sleeve 406 is that the inner groove 436 is now protected from dust ingress. In other words, it is more difficult for the dust to log at the interface of the inner groove than if the groove was provided along the outer surface 440 of the number sleeve 406. This feature is particularly important for resettable drug delivery devices that will have to function over a longer period of time compared to non-resettable devices.
The effective drive diameter (represented by “D”) of the grooved interface between the number sleeve 406 and the inner housing 408 is reduced compared to certain known drug delivery devices for the same outer body diameter. . This improves efficiency and allows the drug delivery device to function with a lower pitch (represented by “P”) for this groove and groove-guided connection. In other words, the helix angle of the screw is here proportional to the ratio of P / D because it determines whether the number sleeve rotates or locks to the inner body when pushed axially. .
The number sleeve 406 does not have to divide this length into the space required for the number sleeve 406 and the space required for clickers and dose limiters, but rather the length of the mechanism is "L ”430. One advantage of this configuration is that it ensures good axial engagement between the number sleeve 406 and the outer housing 404. This improves the functionality (and recognizable quality) of the dose setting mechanism when using the drug delivery device to dial and drain the maximum user settable dose. FIG. 26 illustrates a dose setting mechanism 400 in which a maximum configurable dose of 80 international units (“IU”) is dialed out.
Another advantage is that it allows the scale arrangement 442 to be hidden within the outer housing 404 even when the number sleeve 406 is fully dialed and ejected, as can be seen from FIG. It is. However, the design does not limit the position of the window 444, which can be positioned near the dose dial grip 402 of the device. In the arrangement illustrated in FIGS. 25 and 26, the scale arrangement 442 could only be seen through the window 444.
The driver 209 also has a flat internal through-hole (even if made of two parts or a single integral part) and in addition has a screw configuration that can be molded with an axially moving core pin. Can be made. This avoids the disadvantages of a driver that has an internal thread with more than one turn and thus requires a core pin that is rotated several times during the molding removal process.
One potential disadvantage of utilizing a dose setting mechanism that includes an inner housing 408 is that the use of the inner housing 408 adds part parts to the overall dose setting mechanism 400. Thus, the inner housing 408 will tend to increase the overall wall thickness that should be designed to fit between the clutch 405 and the number sleeve 406. One way to avoid this design problem is to reduce the diameter of the clutch 405. This time, the thread form between the driver 409 and the spindle 414 overlaps the spindle groove form (having a similar diameter) that interfaces with a groove along the inner surface of the inner housing 408 or body portion 516. This can be accomplished by including a male internal mechanism 454 on the driver 409 and a female external groove configuration on the spindle 414.
Overlapping groove configurations on the spindle 414 reduce the effective diameter of the screw interface with the driver 409. This also reduces the possible outer diameter of the driver 409 that allows the addition of the inner housing 408 without increasing the overall outer diameter of the dose setting mechanism 400. Another additional benefit by reducing the effective diameter of the screw interface with the driver 409 is that it improves the efficiency of the drug delivery device during administration, as previously described.
The window 444 through which the scale arrangement 442 can be viewed is simply an opening in the outer housing 404 or a scale arrangement along a portion of the outer surface 440 on the number sleeve 406 (ie, printed or A colorless lens or window designed to enlarge the number of laser-marked doses) can be included.
Connection of the cartridge holder into the outer housing 404 can be accomplished using a screw or bayonet type connection. Alternatively, any similar rugged design used in drug delivery devices that require a large cylindrical portion that can be removed and then reinstalled could be used.
As described above, the first arrangement of the drug delivery device illustrated in FIGS. 16-20 and the second arrangement of the drug delivery device illustrated in FIGS. 21-24 include a spindle having two helical grooves. Specifically, the spindle preferably has two oppositely overlapping groove configurations that extend for at least the majority of the length of the spindle. Each groove configuration is effectively continuous over many turns. In one preferred arrangement, each groove of the spindle engages either a non-continuous helical groove configuration on the body portion or the driver. Preferably, either or both of the body and driver non-continuous thread forms comprise a complete screw of less than one turn.
These preferred arrangements of spindle and driver configurations can be used in drug delivery devices such as injection pen type devices. For some injection pen type devices, a rugged tool design is one important challenge to reduce overall manufacturing costs and also provide good dose accuracy. Thus, Applicant's application spindle and driver design can also be used in various types of drug delivery devices, such as reusable or disposable pen injection devices.
Both groove-shaped leads on the spindle help control the accuracy of the dose administered. This is in contrast to certain prior art devices where dose accuracy depends on both the groove configuration on the spindle and the groove configuration on the driver.
One exemplary arrangement of Applicants' spindle and driver arrangement is illustrated in FIGS. FIG. 27 illustrates a driver 530 and body portion 516 that may be used in a drug delivery device, such as the drug delivery device illustrated in FIGS. In FIG. 27, the driver 530 is illustrated as a single component. However, like the driver 230 illustrated in FIGS. 15-18, the driver 530 alternatively includes a first driver portion and a second driver portion.
As illustrated in FIGS. 27-28, the driver 530 includes a generally tubular member extending between the distal end 531 and the proximal end 532. The driver 530 has a first groove configuration 568 at the distal end. Preferably, the first groove form 568 includes a partial male groove form that engages one of the helical grooves along the surface 560 of the spindle 542.
The housing insert 516 is also illustrated in FIG. The housing insert 516 includes a groove portion 520 that engages a helical groove provided on the spindle 542.
In one exemplary arrangement of spindle and driver designs, as illustrated in FIGS. 27-28, the driver 530 includes a male groove configuration 568 placed at the distal end 531 of the driver. This male groove form 568 is present on the inner surface 571 of the driver 530 and preferably includes less than a single groove form. This groove configuration engages a first groove 519 provided along the surface of the spindle 542. In the preferred arrangement, this first spindle groove 519 is effectively continuous not only to the portion of the spindle surface 560 but also to the length of the majority of the spindle as shown. In this case, if the driver 530 is rotated relative to the spindle 542 during dose setting (as discussed above), then the axial movement of the spindle 542 relative to the housing during dose administration will cause the spindle 542 to move. It will depend on the pitch of the upper spiral grooves 519 and 521 and will not depend on the pitch of the male groove form 568 on the driver. This is in contrast to what occurs in the prior art drug delivery devices illustrated in FIGS. 1-13 and discussed above.
FIG. 28 illustrates the spindle 542 engaged with the driver 530 and the insert 516. In one arrangement, the two pitches of the spindle are in some separate ratio to each other, such as the same pitch 1: 1, or a ratio such as 2: 1, 1.66: 1. However, if the grooves do not overlap as in the case of using the prior art, there is no limit to the ratio of the two pitches, and the spindle can be similarly molded in the open / close jig structure. In contrast to the spindle of the prior art drug delivery device illustrated in FIGS. 1-13 where the molding of the driver 30 requires a core pin that must be rotated and removed from the mold, it is illustrated in FIG. The driver 530 (since it has less than one turn of the groove) can be advantageously molded with two cores that neither rotate when leaving the mold. For example, during the molding process of this driver 530, these two cores can simply be moved axially during the part removal process. Thus, the use of two such molds can significantly reduce the cost, maintenance and cycle time of the molding tool used to mold this preferred driver configuration.
The preferred design of this spindle 542 with two overlapping grooves can be implemented in several ways. As mentioned above, one key advantage of such a spindle structure is that the arrangement of spindle 542 and driver 530 can be molded through a less complex method. Further, when the driver 530 is advanced during dose administration, the advancement of the spindle 542 in the distal direction depends on the pitch magnitude of the first and second groove configurations 519, 521 of the spindle 542. Thus, the dose to be administered is linked only to the dimensions of the spindle and not to any other parts. Thus, this spindle could be made of a material with very low or consistent shrinkage to improve dose accuracy.
In addition, however, as illustrated in FIG. 27, the helical groove configuration 568 of the driver 530 is radially outward within the tubular body of the driver, as in the prior art driver illustrated in FIGS. Rather than a female form that cuts into a male form, it projects radially inward. Using such a male configuration as illustrated in FIG. 27, the outer diameter D1570 of the driver 530 can be reduced over other prior art types of devices. One advantage of reducing the outer diameter D1570 of the driver 530 is that this reduced diameter can make the overall diameter of the drug delivery device smaller. One advantage of a more compact drug delivery device is that it makes the visual appearance of the drug delivery device closer to that of a typical writing pen. By way of example only, the outer diameter D2 of the drug delivery device 201 illustrated in FIG. 14 can be made smaller than the outer diameter D3 of the drug delivery device 201 illustrated in FIG.
In addition, if the driver 30 engages the spindle helix over a larger portion of the spindle as illustrated in the spindle and driver arrangement of FIGS. However, if the spindle groove 519 engages only at the distal end of the distal end 531 of the driver, the spindle 542 can extend proximally beyond the end of the driver 530. One advantage of such a driver and spindle arrangement is that it can reduce the overall length of the drug delivery device. As just one example of this advantage, the total length L211 of the prior art drug delivery device illustrated in FIGS. 1-13 can be reduced to the shorter total length L3120 of the drug delivery device 201 illustrated in FIG. .
In the driver and spindle arrangement illustrated in FIGS. 27-28, this arrangement can be utilized in a disposable or non-resetable drug delivery device. In an alternative arrangement, the driver can be divided into multiple (eg, two or more) portions that are axially separated. In such an arrangement, the first driver portion (closest to the cartridge) will engage the spindle helix and be engaged with a dose limiting mechanism similar to the dose mechanism 238 illustrated in FIG. There will be. The short non-continuous thread form 568 on the first driver part and the continuous groove form 519 on the spindle push the spindle back into the second driver part so that the first driver part just rotates. Designs for drug delivery devices are possible. There is no need for the two driver parts to be arranged concentrically. Such a configuration would be added to the overall outer diameter of the drug delivery device.
Another advantage of using a spindle 542 having two overlapping groove configurations 519, 521 is that such an arrangement creates a radial space within the drug delivery device. In one arrangement, this radial space can be used to introduce an internal body component within a drug delivery device, such as the internal body 208 illustrated in FIG. 21 and described in detail above.
However, as can be seen from the spindle 542 illustrated in FIG. 28, it is advantageous for the driver 530 to have a thread interface pitch, which is a specific multiple pitch of the groove configuration 520 with the spindle 542. . One reason for this is that it can be ensured that both groove configurations 519, 521 intersect each other in a defined angular plane that is rotated about the axis of the spindle 542.
By way of example only in the case of the spindle illustrated in FIG. 28, the pitch of the driver 530 relative to the spindle groove configuration 519 is equal to that of the spindle groove 521 relative to the groove configuration of the housing portion 516. One advantage of this configuration is that it ensures that the groove shapes intersect each other every 90 degrees using two equally spaced starts for each groove shape. is there. Using this typical groove pitch, this allows the spindle 542 to be molded using two sliding open / close jig structures. Of course, other ratios may be used. However, as those skilled in the art will appreciate, there is a limited number of range ratios that the spindle could be easily molded using an injection molding method. Alternatively, if the ratio is 2: 1, the grooves intersect every 60 degrees and this ratio can still be molded with an open and closed mold fixture structure using carefully designed screw configurations. .
In one of Applicant's preferred drug delivery device spindle and drive arrangements, the ratio of the pitch of these two spindle groove configurations defines certain mechanical advantages of the drug delivery device. In one arrangement, this mechanical advantage can be defined by the formula (A + B) / A. In this equation, A can define the groove pitch between the spindle 519 and the housing portion 516, and B can define the groove pitch between the spindle helical groove 521 and the driver groove portion 568. This mechanical advantage then defines the maximum dial out distance for a given maximum dose value. By way of example only, the mechanical advantage of a maximum dose of 3: 1 (“3: 1”) and 80 international units (“IU”) is 33.12 millimeters for a nominal spindle inner diameter of 9.6 millimeters. Dial-out distance will be provided.
This dial-out distance can affect the overall length of the drug delivery device. In particular, if the number on the number sleeve must be kept hidden inside the housing when the maximum dose is dialed as illustrated in FIGS. 25-26, it is the total length of the drug delivery device. Significantly affected.
FIG. 29 shows an enlarged view of a spindle 642 according to the present invention that can be used with a dose setting mechanism as described above. The spindle 642 has a first spiral groove 619 and a second spiral groove 621 provided along the outer surface of the shaft. The first spiral groove 619 is a drive sleeve-shaped groove, and the second spiral groove 621 is a body (housing) -shaped groove. As indicated by reference numeral 622, a cut is provided in the external shape of the spindle to provide an open / close (molding) jig for manufacturing the spindle 642.
Exemplary embodiments of the present invention have been described. However, one of ordinary skill in the art appreciates that changes and modifications can be made to these embodiments without departing from the true scope and spirit of the invention as defined by the claims.
A spindle (242; 414; 542; 642) for driving the plug (218) of the cartridge (220), which spindle:
A generally circular axis having an outer surface (560), wherein the generally circular axis extends from a distal end to a proximal end of the circular axis;
A first spiral groove (219; 519; 619) provided along a first portion of the outer surface (560) of the generally circular axis, wherein the first spiral groove is a first A second spiral groove (221; 521; 621) provided along a second portion of the outer surface (560) of the generally circular axis, wherein the second spiral A spindle comprising a groove (221; 521; 621) overlying the first helical groove (219; 519; 619), wherein the second helical groove has a second pitch.
The first spiral groove (219; 519; 619) includes the first pitch on the first side; and the second spiral groove (221; 521; 621) is the first spiral groove ( 219; 519; 619), the spindle of claim 1, including the second two pitches opposite the first side.
The first pitch of the first spiral groove (219; 519; 619) is equivalent to the second pitch of the second spiral groove (221; 521; 621) according to claim 1 or 2. The spindle described.
The second spiral groove (221; 521; 621) provided along the second two portions of the outer surface (560) of the generally circular shaft is the first spiral groove (219; 519; 619), the spindle according to any one of claims 1-3.
5. The spindle according to claim 1, wherein the first spiral groove (219; 519; 619) and / or the second spiral groove (221; 521; 621) comprises a spiral female groove. .
The first spiral groove (219; 519; 619) and / or the second spiral groove (221; 521; 621) along the outer surface (560) of the generally circular axis, 6. A spindle according to any one of the preceding claims, extending from about the distal end of the spindle (242; 414; 542; 642) to about the proximal end of the spindle.
The first pitch of the first helical grooves (219; 519; 619) provided along the first portion of the outer surface (560) has a first diameter and the outer The second pitch of the second helical groove (221; 521; 621) provided along the second portion of the surface (560) has a second diameter, wherein the first pitch The spindle according to any one of the preceding claims, wherein the diameter is generally equal to the second diameter.
A spindle (242; 414; 542; 642) according to any one of claims 1 to 7, and further comprising a driver (230; 409; 530) for driving the spindle. A dose setting mechanism for use with a drug delivery device, wherein the driver comprises a helical groove configuration that engages the first helical groove (219; 519; 619) of the spindle. , Dose setting mechanism.
Helix comprising a spindle (242; 414; 542; 642) according to any one of the preceding claims and engaging with said second helical groove (221; 521; 621) of said spindle A dose setting mechanism for use with a drug delivery device, further comprising a drug delivery body (240; 404, 408; 516) having a groove configuration.
10. A dose setting mechanism according to claim 8 or 9, wherein the spiral groove on the driver and / or on the drug delivery body comprises a partial groove configuration, preferably less than a single spiral groove.
11. A dose setting mechanism according to any one of claims 8 to 10, wherein the helical groove on the driver and / or on the drug delivery body comprises a male helical groove.
12. A dose setting mechanism according to any one of claims 9 to 11, wherein the helical groove on the drug delivery device body comprises an inner body (408) and / or an outer body (240; 404; 516).
Preferably, a dose setting mechanism for use with a drug delivery device according to any one of claims 8-12, wherein the mechanism is:
Housing (240; 404, 408; 516);
A rotating sleeve (210; 406) in rotatable engagement with the housing;
A spindle (242; 414; 542) having a driver (230; 409; 530) releasably connected to the rotating sleeve; and two overlapping spiral grooves (219, 221; 519, 521; 619, 621) 642) where the spindle is coupled to the driver in an effective manner so that when the user sets the dose by rotating the rotating sleeve, the driver also rotates. Including a dose setting mechanism.
14. A dose setting mechanism according to claim 13, comprising a resettable dose setting mechanism, wherein the driver (230; 409) is a first part (244; 412) and a second part (246; 407). Wherein the dose setting mechanism is coupled together in an effective manner such that when the user sets the dose, the first and second parts rotate together .
14. A dose setting mechanism according to claim 13, comprising a non-resetable dose setting mechanism.
JP2012513569A 2009-06-01 2010-05-28 Spindle for drug delivery device Active JP5903042B2 (en)
US61/182,856 2009-06-01
PCT/EP2010/057486 WO2010139640A1 (en) 2009-06-01 2010-05-28 Spindle for a drug delivery device
JP2012528628A true JP2012528628A (en) 2012-11-15
JP5903042B2 JP5903042B2 (en) 2016-04-13
JP2012513569A Active JP5903042B2 (en) 2009-06-01 2010-05-28 Spindle for drug delivery device
BR (1) BRPI1011428B1 (en)
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2010-05-28 BR BRPI1011428-9A patent/BRPI1011428B1/en active IP Right Grant
2010-05-28 CN CN201080024059.4A patent/CN102448524B/en active IP Right Grant
US10034982B2 (en) 2018-07-31
BRPI1011428B1 (en) 2019-11-19
JP5752693B2 (en) 2015-07-22 Assembly and piston rod for a drug delivery device
2015-12-14 A911 Transfer of reconsideration by examiner before appeal (zenchi)
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