Medical delivery device with axially expandable drive belt

Abstract

A drug delivery device usable with a drug container in which advancement of a piston within the container expels the drug. The device comprises a shell and a driving assembly. The drive assembly includes a drive belt having a distal edge section and a proximal edge section. The drive belt has a retracted configuration defining a two-dimensional helix and an extended configuration defining a three-dimensional helix. The drive belt is movable from a retracted configuration to an extended configuration, wherein this movement defines a drive axis and advances the piston. In some embodiments, the drive belt may not rotate as it advances, while in other embodiments, the belt is indeed rotating. The disclosed drive assembly includes a manually driven assembly, a spring driven assembly, and a motor driven assembly. The container may be replaceable to allow reuse of the device. In some embodiments, a replaceable cartridge may be employed that includes both a medicament container and a drive belt.

Description

Technical Field

[0001] This application is a divisional application of Chinese patent application 202210299640.1. The present disclosure relates to medical delivery devices such as injection devices. Background Art

[0002] Conventional injection devices are often used to inject medication into a patient. For example, diabetics often use an injection pen that utilizes a disposable cartridge containing insulin. Such a pen generally includes an elongated rod that acts on a piston within the cartridge. When the rod advances the piston, the medication is dispensed into the patient through a needle.

[0003] Throughout the injection process, including when the rod has reached the limit of forward advancement into the cartridge, the rod must protrude outward from the cartridge to engage a drive mechanism within the pen. When the rod has been fully retracted, it must also be contained within the pen so that the rod can be inserted into a new cartridge filled with medication. As a result, conventional injection pens are generally slender and thin, with the length of the injection pen being greater than twice the length of the cartridge tube containing the medication therein. Similarly, for non-pen-shaped refillable injection devices, the length of the device is generally greater than twice the length of the cartridge tube containing the medication therein.

[0004] When such injection devices are used to self-administer medications at various times throughout the day, it is desirable that the injection device be easily portable to the user. For example, diabetics often use injection devices to self-administer insulin and carry the device with them throughout the day. Although conventional injection pens and similar devices are small enough to be portable, the length of such devices often makes the transportation of the device inconvenient. Summary of the invention

[0005] According to an embodiment of the present disclosure, a drug delivery device for use with a container is provided, the container having a container body containing a drug and defining an outlet. The container includes a piston disposed in the container body, and the advancement of the piston in the container body permits the drug to be discharged through the outlet. The delivery device includes: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston in the container. The drive assembly includes a drive belt having a distal edge segment and a proximal edge segment. The drive belt is incrementally movable around a drive axis between a retracted configuration and an extended configuration. In the retracted configuration, the retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration, the extended portion of the drive belt defines a three-dimensional spiral. A thrust member is engaged with the drive belt and is rotatable relative to the drive belt and the housing. In response to the rotation of the thrust member, the drive belt is movable between the retracted configuration and the extended configuration without any rotation relative to the housing or the container. Other embodiments of exemplary devices are provided.

[0006] In another embodiment, a drug delivery device includes a delivery device, the delivery device including: a housing adapted to be coupled to a container; and a drive assembly coupled to the housing and adapted to advance a piston within the container. The drive assembly includes a drive belt having a distal edge segment and a proximal edge segment. The drive belt has a retracted configuration and an extended configuration. The retracted portion of the drive belt defines a two-dimensional spiral in the retracted configuration, and the extended portion of the drive belt defines a three-dimensional spiral in the extended configuration. The drive belt is incrementally movable from the retracted configuration to the extended configuration. The movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis. A drive mechanism is operably coupled to the drive belt and defines a secondary axis parallel to the drive axis. The drive mechanism generates a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0007] In yet another embodiment, a drug delivery device includes a delivery device, the delivery device including: a housing adapted to be coupled to a container; and a drive assembly coupled to the housing and adapted to advance a piston within the container. The drive assembly includes a drive belt having a distal edge segment and a proximal edge segment. The drive belt has a retracted configuration and an extended configuration, wherein the retracted portion of the drive belt defines a two-dimensional spiral in the retracted configuration, and the extended portion of the drive belt defines a three-dimensional spiral in the extended configuration. The drive belt can be incrementally moved from the retracted configuration to the extended configuration to advance the piston within the container body. The movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis. One of the distal edge segment and the proximal edge segment defines a plurality of edge protrusions, and the other of the distal edge segment and the proximal edge segment defines a plurality of openings, the openings being configured to receive corresponding edge protrusions in an interlocking manner when the drive belt is in the extended configuration.

[0008] In yet another embodiment, a drug delivery device includes a drive module and a cassette. The drive module includes a module housing, a motor disposed in the module housing, and a drive gear operably coupled to a shaft of the motor. The cassette includes a cassette housing configured to be coupled to the module housing. The cassette includes: a container body that holds the drug and defines an outlet; and a piston that is disposed in the container body. The drive belt can be incrementally extended axially to advance the piston in the container body to discharge the drug through the outlet. The thrust member includes a driven gear element operably coupled to the drive gear. The thrust member engages with the drive belt and is movable to extend or retract the drive belt. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The above-mentioned features and other features of the present disclosure and the manner of achieving them will become more apparent, and the invention will be better understood, by referring to the following description of the embodiments of the present disclosure considered in conjunction with the accompanying drawings, in which: Figure 1is a schematic perspective view of an exemplary drive belt that can be axially extended without rotating the drive belt.

[0010] Figure 2 is a schematic perspective view of another exemplary drive belt that rotates as it extends axially.

[0011] Figure 3 is a schematic perspective view of another drive belt that rotates as it extends axially.

[0012] Figure 4 is a partially exploded view of an exemplary drive belt.

[0013] Figure 5 yes Figure 4 Detailed view of the drive belt.

[0014] Figure 6 yes Figure 4 Another detailed view of the drive belt.

[0015] Figure 7 is another view of the drive belt, with the belt unrolled.

[0016] Figure 8 yes Figure 7 Detailed view of the drive belt.

[0017] Fig. 9 yes Figure 7 Edge view of the drive belt.

[0018] Fig.10 is a schematic end view of an exemplary drive assembly having a drive belt that does not rotate when the drive belt is extended.

[0019] Fig.11 yes Fig.10 Another schematic diagram of the drive assembly of FIG.

[0020] Fig.12 is a schematic end view of an exemplary drive belt that does not rotate as it extends.

[0021] Fig.13 is a schematic side view of a drive assembly having Fig.12 drive belt.

[0022] Fig.14 is a schematic end view of another drive assembly having a non-rotating drive belt.

[0023] Fig.15 is a schematic side view of an exemplary drive assembly having Fig.14 drive belt.

[0024] Fig.16 is a schematic end view of another drive assembly having a non-rotating drive belt.

[0025] Fig.17 yes Fig.16 Schematic side view of a drive assembly.

[0026] Fig.18 is a schematic end view of a drive belt having elongated ribs.

[0027] Fig.19 is a schematic end view of a drive belt having isolated posts.

[0028] Fig. 20 is a schematic side view of an exemplary drive assembly having a non-rotating drive belt.

[0029] Fig.21 is a schematic side view of another drive assembly having a non-rotating drive belt.

[0030] Fig. 22 is a schematic end view of an exemplary drive assembly including a drive belt that rotates as it extends axially.

[0031] Fig.23 is a schematic end view of another drive assembly including a drive belt that rotates as it extends axially.

[0032] Fig.24 yes Fig.23 Schematic side view of a drive assembly.

[0033] Fig.25 is a schematic end view of a drive assembly having an internal gear drive for rotating a drive belt.

[0034] Fig.26 is a schematic end view of another drive assembly having an internal gear drive for rotating a drive belt.

[0035] Fig. 27 is a schematic end view of a drive assembly having an external gear drive for rotating a drive belt.

[0036] Fig.28 is a schematic end view of another drive assembly having an external gear drive for rotating a drive belt.

[0037] Fig.29 yes Fig.28 Schematic side view of a drive assembly.

[0038] Fig.30 is a schematic end view of a drive assembly having an external belt drive.

[0039] Fig.31 is a schematic end view of a drive assembly having a plurality of external gears for rotating a drive belt.

[0040] Fig.32 is a schematic end view of another drive assembly having a plurality of external gears for rotating a drive belt.

[0041] Fig.33 yes Fig.32 Schematic side view of a drive assembly.

[0042] Fig.34 is a schematic end view of an external worm gear drive.

[0043] Fig.35 is a schematic end view of another external worm gear drive.

[0044] Fig.36 is a schematic end view of a drive belt having external ribs.

[0045] Fig.37 is a schematic end view of a drive belt having an external groove.

[0046] Fig.38 is a schematic end view of a drive assembly having a drive belt with an external groove and a key drive.

[0047] Fig.39 yes Fig.38 Schematic side view of a drive assembly.

[0048] Fig.40 is a schematic end view of another drive assembly having a drive belt with an external groove and a key drive.

[0049] Fig.41 yes Fig.40 Schematic side view of a drive assembly.

[0050] Fig.42 is a schematic side view of a drive assembly in which the retracting portion of the drive belt is driven by the bobbin.

[0051] Fig.43 is a schematic end view of a drive assembly having a reciprocating drive member.

[0052] Fig.44 is a schematic perspective view of a drive assembly having a worm gear.

[0053] Fig.45 is a schematic end view of a drive assembly having a reciprocating drive member with a plurality of ratchet members.

[0054] Fig.46 is a schematic diagram of an exemplary device having an inline drive assembly.

[0055] Fig.47 yes Fig.46 Side view of the device.

[0056] Fig.48 yes Fig.47 End view of the device.

[0057] Fig.49 is a schematic diagram of an exemplary device having a secondary axis.

[0058] Fig.50 yes Fig.49 Side view of the device.

[0059] Fig.51 yes Fig.50 End view of the device.

[0060] Fig.52 is a schematic diagram of another device having a secondary axis.

[0061] Fig.53 yes Fig.52 Side view of the device.

[0062] Fig.54 yes Fig.53 End view of the device.

[0063] Fig.55 is a schematic diagram of an exemplary device having a secondary axis.

[0064] Fig.56 yes Fig.55 Side view of the device.

[0065] Fig.57 yes Fig.56 End view of the device.

[0066] Fig.58 yes Fig.56 End view of the device.

[0067] Fig.59 In the dial dose setting configuration Fig.55 Schematic diagram of the driving component mechanism of the device.

[0068] Fig.60 In the injectable dose delivery configuration Fig.55Schematic diagram of the driving component mechanism of the device.

[0069] Fig.61 is a schematic diagram of an exemplary device having a secondary axis.

[0070] Fig.62 yes Fig.61 Side view of the device.

[0071] Fig.63 yes Fig.62 End view of the device.

[0072] Fig.64 yes Fig.62 End view of the device.

[0073] Fig.65 In the dial dose setting configuration Fig.61 Schematic diagram of the driving component mechanism of the device.

[0074] Fig.66 In the injectable dose delivery configuration Fig.61 Schematic diagram of the driving component mechanism of the device.

[0075] Fig.67 is a schematic diagram of an exemplary device having a secondary axis.

[0076] Fig.68 yes Fig.67 Side view of the device.

[0077] Fig.69 yes Fig.68 End view of the device.

[0078] Fig.70 yes Fig.68 End view of the device.

[0079] Fig.71 In the dial dose setting configuration Fig.67 Schematic diagram of the driving component mechanism of the device.

[0080] Fig.72 In the injectable dose delivery configuration Fig.67 Schematic diagram of the driving component mechanism of the device.

[0081] Fig.73 is a schematic diagram of an exemplary device having a secondary axis.

[0082] Fig.74 yes Fig.73 Side view of the device.

[0083] Fig.75 yes Fig.74 End view of the device.

[0084] Fig.76 yes Fig.74 End view of the device.

[0085] Fig.77 In the dial dose setting configuration Fig.73 Schematic diagram of the driving component mechanism of the device.

[0086] Fig.78 In the injectable dose delivery configuration Fig.73 Schematic diagram of the driving component mechanism of the device.

[0087] Fig.79 is a schematic diagram of an exemplary device having a secondary axis.

[0088] Fig.80 yes Fig.79 Side view of the device.

[0089] Fig.81 yes Fig.80 End view of the device.

[0090] Fig.82 yes Fig.80 End view of the device.

[0091] Fig.83 In the dial dose setting configuration Fig.79 Schematic diagram of the driving component mechanism of the device.

[0092] Fig.84 In the injectable dose delivery configuration Fig.79 Schematic diagram of the driving component mechanism of the device.

[0093] Fig.85 is a schematic diagram of an exemplary device having a secondary axis.

[0094] Fig.86 yes Fig.85 Side view of the device.

[0095] Fig.87 yes Fig.86 End view of the device.

[0096] Fig.88 yes Fig.86 End view of the device.

[0097] Fig.89 In the dial dose setting configuration Fig.85 Schematic diagram of the driving component mechanism of the device.

[0098] Fig.90 In the injectable dose delivery configuration Fig.85 Schematic diagram of the driving component mechanism of the device.

[0099] Fig.91 is a schematic diagram of an exemplary device having a secondary axis.

[0100] Fig.92 yes Fig.91 Side view of the device.

[0101] Fig.93 yes Fig.92 End view of the device.

[0102] Fig.94 yes Fig.92 End view of the device.

[0103] Fig.95 yes Fig.91 Schematic diagram of the driving component mechanism of the device.

[0104] Fig.96 yes Fig.91 Schematic diagram of the driving component mechanism of the device.

[0105] Fig.97 is a schematic diagram of an exemplary device having a secondary axis.

[0106] Fig.98 yes Fig.97 Side view of the device.

[0107] Fig.99 yes Fig.98 End view of the device.

[0108] Fig.100 yes Fig.98 End view of the device.

[0109] Fig.101 yes Fig.97 Schematic diagram of the driving component mechanism of the device.

[0110] Fig.102 yes Fig.97 Schematic diagram of the driving component mechanism of the device.

[0111] Fig.103 is a schematic diagram of a device having a detachable cartridge and a drive module.

[0112] Fig.104 yes Fig.103 Side view of the device.

[0113] Fig.105 yes Fig.104 End view of the device.

[0114] Fig.106 yes Fig.104 End view of the device.

[0115] Fig.107 yes Fig.104 Side view of the box.

[0116] Fig.108 yes Fig.104 Side view of the drive component mechanism module.

[0117] Fig.109 is a schematic diagram of an exemplary device having a detachable cartridge and a drive module.

[0118] Fig.110 yes Fig.109 Side view of the device.

[0119] Fig.111 yes Fig.110 End view of the device.

[0120] Fig.112 yes Fig.110 End view of the device.

[0121] Fig.113 yes Fig.110 Side view of the box.

[0122] Fig.114 yes Fig.110 Side view of the drive component mechanism module.

[0123] Fig.115 is a schematic diagram of an exemplary device having a detachable cartridge and a drive module.

[0124] Fig.116 yes Fig.115 Side view of the device.

[0125] Fig.117 yes Fig.116 End view of the device.

[0126] Fig.118 yes Fig.116 End view of the device.

[0127] Fig.119 yes Fig.116 Side view of the box.

[0128] Fig.120 yes Fig.116 Side view of the drive component mechanism module.

[0129] Fig.121 is a schematic diagram of an exemplary device having a detachable cartridge and a drive module.

[0130] Fig.122 yes Fig.121 Side view of the device.

[0131] Fig.123 yes Fig.122 End view of the device.

[0132] Fig.124 yes Fig.122 End view of the device.

[0133] Fig.125 yes Fig.122 Side view of the box.

[0134] Fig.126 yes Fig.122 Side view of the drive component mechanism module.

[0135] Fig.127 is a schematic diagram of an exemplary device having a detachable cartridge and a drive module.

[0136] Fig.128 yes Fig.127 Side view of the device.

[0137] Fig.129 yes Fig.128 End view of the device.

[0138] Fig.130 yes Fig.128 End view of the device.

[0139] Fig.131 yes Fig.128 Side view of the box.

[0140] Fig.132 yes Fig.128 Side view of the drive component mechanism module.

[0141] Fig.133 is a schematic diagram of an exemplary drive member mechanism module with an attached cartridge and additional cartridges.

[0142] Fig.134 yes Fig.133 Schematic diagram of the drive component mechanism module and multiple boxes.

[0143] Fig.135 is a schematic diagram of an exemplary drive member mechanism module with an attached cartridge and additional cartridges.

[0144] Fig.136 yes Fig.135 Schematic diagram of the drive component mechanism module and multiple boxes.

[0145] Fig.137 is a side view of an exemplary device having a cartridge and a modular drive member mechanism.

[0146] Fig.138 yes Fig.137 Another side view of the device.

[0147] Fig.139 yes Fig.138 End view of the device.

[0148] Fig.140 It is along Fig.137 A cross section taken along line AA.

[0149] Fig.141 It is along Fig.140 A cross section taken along line BB.

[0150] Fig.142 It is along Fig.140 A cross section taken along line CC.

[0151] Fig.143 yes Fig.137 An exploded view of the device showing the separated drive member mechanism and box.

[0152] Fig.144 yes Fig.137 An exploded view of the device showing the separated drive member mechanism and box.

[0153] Fig.145 yes Fig.137 An exploded view of the device showing the separated drive member mechanism and box.

[0154] Fig.146 is a side view of an exemplary device having a cartridge and a modular drive member mechanism.

[0155] Fig.147 yes Fig.146 Another side view of the device.

[0156] Fig.148 yes Fig.147 End view of the device.

[0157] Fig.149 It is along Fig.146 A cross section taken along line AA.

[0158] Fig.150 It is along Fig.149 A cross section taken along line BB.

[0159] Fig.151 It is along Fig.149 A cross section taken along line CC.

[0160] Fig.152 yes Fig.146An exploded view of the device showing the separated drive member mechanism and box.

[0161] Fig.153 yes Fig.146 An exploded view of the device showing the separated drive member mechanism and box.

[0162] Fig.154 yes Fig.146 An exploded view of the device showing the separated drive member mechanism and box.

[0163] Fig.155 is a perspective view of the box.

[0164] Fig.156 yes Fig.155 Side view of the box.

[0165] Fig.157 yes Fig.155 Another side view of the box.

[0166] Fig.158 yes Fig.155 End view of the box.

[0167] Fig.159 It is along Fig.156 A cross section taken along line DD.

[0168] Fig.160 It is along Fig.156 A cross section taken along line EE.

[0169] Fig.161 It is along Fig.157 A cross section taken along line FF.

[0170] Fig.162 It is along Fig.159 A cross section taken along line GG.

[0171] Fig.163 It is along Fig.159 A cross section taken along line HH.

[0172] Fig.164 is an exploded perspective view of the box.

[0173] Fig.165 yes Fig.164 A perspective view of the box base.

[0174] Fig.166 yes Fig.164 A perspective view of the box base.

[0175] Fig.167 yes Fig.164 End view of the box base.

[0176] Fig.168 yes Fig.164 Side view of the box base.

[0177] Fig.169 yes Fig.164 End view of the box base.

[0178] Fig.170 yes Fig.164 Side view of the box base.

[0179] Fig.171 yes Fig.164 A perspective view of a box ring.

[0180] Fig.172 yes Fig.164 A perspective view of a box ring.

[0181] Fig.173 yes Fig.164 End view of the box collar.

[0182] Fig.174 yes Fig.164 Side view of the box collar.

[0183] Fig.175 yes Fig.164 End view of the box collar.

[0184] Fig.176 yes Fig.164 Side view of the box collar.

[0185] Fig.177 yes Fig.164 Perspective view of a box ring.

[0186] Fig.178 yes Fig.164 Perspective view of a box ring.

[0187] Fig.179 yes Fig.164 End view of the box ring.

[0188] Fig.180 yes Fig.164 Side view of the box ring.

[0189] Fig.181 yes Fig.164 End view of the box ring.

[0190] Fig.182 yes Fig.164 A perspective view of the box feet.

[0191] Fig.183 yes Fig.164 A perspective view of the box feet.

[0192] Fig.184 yes Fig.164 End view of the box foot.

[0193] Fig.185 yes Fig.164 Side view of the box foot.

[0194] Fig.186 yes Fig.164 End view of the box foot.

[0195] Fig.187 yes Fig.164 Perspective view of a box nut.

[0196] Fig.188 yes Fig.164 Perspective view of a box nut.

[0197] Fig.189 yes Fig.164 End view of a box nut.

[0198] Fig.190 yes Fig.164 Side view of a box nut.

[0199] Fig.191 yes Fig.164 End view of a box nut.

[0200] Fig.192 It is along Fig.190 The cross section is taken along line JJ.

[0201] Fig.193 yes Fig.164 A perspective view of a cartridge holder.

[0202] Fig.194 yes Fig.164 A perspective view of a cartridge holder.

[0203] Fig.195 yes Fig.164 End view of the cartridge holder.

[0204] Fig.196 yes Fig.164 Side view of the cartridge holder.

[0205] Fig.197 yes Fig.164 End view of the cartridge holder.

[0206] Fig.198 yes Fig.164 A perspective view of a cartridge holder.

[0207] Fig.199 yes Fig.164 A perspective view of the drive belt.

[0208] Fig.200 yes Fig.164 A perspective view of the drive belt.

[0209] Fig.201 yes Fig.164 Side view of the drive belt.

[0210] Fig.202 yes Fig.164 End view of the drive belt.

[0211] Fig.203 yes Fig.164 A view of the outer surface of the drive belt when laid flat.

[0212] Fig.204 yes Fig.164 A view of the edge of the drive belt when laid flat.

[0213] Fig.205 yes Fig.164 A view of the inner surface of the drive belt when laid flat.

[0214] Fig.206 The drive belt Fig.203 Detail of the enlarged view of the segment shown in J.

[0215] Fig.207 The drive belt Fig.205 Detail of the enlarged view of the section shown in K.

[0216] Fig.208 are linked together and laid out for the purpose of explanation Fig.164 View of the outer surfaces of the two drive belts.

[0217] Fig.209 are linked together and laid out for the purpose of explanation Fig.164 View of the inner surface of the two drive belts.

[0218] Fig.210 The drive belt Fig.208 Detail of the enlarged view of the section shown in L.

[0219] Fig.211 The drive belt Fig.209 Detail of the enlarged view of the segment shown in M.

[0220] Fig.212 is a schematic diagram of a control system for controlling the amount of dose delivered by the device.

[0221] Fig.213 is a schematic diagram of another control system for controlling the amount of dose delivered by the device.

[0222] Fig.214 yes Fig.213 Schematic top view of the control system.

[0223] Fig.215 is a schematic diagram of another control system for controlling the amount of dose delivered by the device.

[0224] Fig.216 is a schematic diagram of an alternative physical layout of a control system.

[0225] Corresponding reference numerals indicate corresponding parts throughout the several views. Although the exemplification set out herein illustrates embodiments of the disclosure, in several forms, the embodiments disclosed below are not intended to be exhaustive or to be construed as limiting the scope of the invention to the precise forms disclosed. DETAILED DESCRIPTION

[0226] An example of a drug delivery device is provided. One of the advantages may be that such a delivery device may provide a configuration having a relatively short length and a compact configuration. In some embodiments, the device is a disposable device (such as an auto-injector) having a syringe pre-filled with a drug, such as, for example, insulin or other types of medicaments for treating diabetes. In some embodiments, the device includes a disposable syringe cartridge that is removably coupled to a drive housing so that a patient can replace a used cartridge with another cartridge having a new and / or different drug. The drive housing may include electronics for sensing, indicating, displaying, and / or communicating on-board and / or off-board steps in drug delivery.

[0227] The illustrated device utilizes an axially expandable drive belt as part of a drive assembly for dispensing medication. Figures 1 to 3 It can be seen that the drive belt of the exemplary embodiment has a retracted configuration in which the retracted portion of the drive belt 22 defines a two-dimensional spiral and an extended configuration in which the extended portion of the drive belt 24 defines a three-dimensional spiral.

[0228] As used herein, the retracted portion 22 of the drive band defines a proximal end, and the opposite end of the extended portion 24 of the drive band defines a distal end. The drive band can be incrementally shifted between the retracted configuration and the extended configuration to modify the length of the extended portion 24. When the drive band is shifted to the extended configuration, the band forms a three-dimensional spiral, and when the proximal edge region of the band engages the distal edge region of the band, the band is secured to itself.

[0229] Figures 1 to 3 Several different ways in which the drive belt can function are illustrated. Figure 1A drive belt 26 is schematically depicted with an extension 24 of the drive belt advancing without rotation of the extension 24. In such an embodiment, as the extension of the drive belt advances axially, the most recently retracted portion of the belt is stretched radially inward and upward so that the distal edge of the belt being pulled in engages the proximal edge of the belt at the bottom of the extension of the belt. The belt can be guided in this motion by using a cam ramp that engages the proximal edge of the belt being stretched radially inward and upward.

[0230] One advantage of such a non-rotating drive belt is that the support member attached to the distal end of the belt will not rotate and can therefore bear directly on the piston of the drug container without any relative rotational movement between the support member and the piston.

[0231] Figure 2 and Figure 3 The drive belts 28 , 30 are schematically depicted, rotating as they extend axially. Figure 2 The drive belt 28 and Figure 3 The difference between the drive belts 30 shown in FIG. 1 is the manner in which the distal and proximal edges of the belts are joined. Figure 2 The edges of the band 28 shown in the figure protrude inwardly and outwardly to form a protruding lip. Figures 7 to 9 and Fig.33 A similar band is shown in .

[0232] Similar to belt 26, drive belt 30 is formed in a more cylindrical shape, and the proximal and distal edges of the belt do not protrude or form significant discontinuities in the inner and outer surfaces of the extended portion 24 of the belt. Figures 4 to 6 and Fig.11 The drive belt shown in has this type of engagement and is discussed further below.

[0233] The use of a rotating drive belt allows for a wider variety of drive belt configurations than a non-rotating drive belt. However, the rotation of the drive belt will generally require a secondary component that mounts the support member to the drive belt to allow the support member that engages the piston of the medicament container to rotate relative to the drive belt. This will allow the support member to engage the piston of the medicament container without any relative movement between the support member and the piston. This arrangement may also increase the overall length of the drive belt assembly.

[0234] The use of such a drive belt allows an injection device or similar drug delivery device to have a relatively short and compact size due to the short axial length of the retracted portion of the drive belt. Various different drive assemblies for moving the drive belt and device architectures are disclosed herein and discussed below.

[0235] Exemplary Drive Belt Figures 4 to 6An example of a drive belt 32 is shown in FIG. 1 , which forms a generally cylindrical extension (with Figure 1 and Figure 3 The belt 32 will not take any Figure 4 , and is shown in this configuration only to aid understanding of the structure of the belt 32. A foot member 34 is fixed to the distal end of the belt 32. If the belt 32 is used in a non-rotating application, the foot 34 can directly bear against the piston of the drug container. The foot 34 also includes a central hole that can act as a rotatable support. For example, a support member having a protrusion that fits into the central hole of the foot 34 can be rotatably mounted on the foot 34 and directly bear on the piston instead of the foot 34. This arrangement will facilitate the use of the belt 32 in applications in which the drive belt rotates as it advances axially.

[0236] The band 32 has a distal edge section 36 and a proximal edge section 38 which are engageable with each other and are disposed at the distal edge of the band 32. Figure 5 and 6 . The distal edge section 36 faces inwardly and includes a recess 40 disposed between an inwardly protruding lip 42 and an inwardly protruding boss 44. The lip 42 also includes a series of notches 46. The inwardly facing surface of the band 32 also includes a series of raised ribs 48. The ribs 48 may be engaged by a gear or similar drive member mechanism to rotatably drive the movement of the band 32.

[0237] Figure 6 4 and 5. The proximal edge segment 38 can be seen in the figure, and the outwardly facing surface of the band 32 includes a lip 50 and a recess 52 along the proximal edge of the band 32. An axially extending rib 54 is located within the recess 52. When the proximal and distal segments of the band 32 are joined together, the lip 50 fits within the recess 40, wherein the lip 42 and the boss 44 constrain the axial movement of the lip 50. Similarly, the lip 42 fits within the recess 52 and is therefore axially constrained. This axial engagement allows the extended portion of the band 32 to apply axial compressive forces (such as when the piston is biased forward to expel the drug), and resists axial tensile forces to thereby prevent the extended portion of the band from becoming detached from itself due to being axially pulled apart. The rib 54 fits within the notch 46 to provide shear resistance and allow the extended portion of the band to withstand torque that the band may experience when rotating.

[0238] Figures 7 to 9 An example of a drive belt having a proximal edge and a distal edge (with a protruding lip) that form a protruding lip when engaged is shown in FIG. Figure 2 and having side walls that take a slightly conical shape when in the extended position. Figure 7 , the belt 56 is shown laid on a flat surface. Figure 8 and Fig. 9 A more detailed view of belt 56 is provided.

[0239] The drive band 56 includes a recessed area 58 along the proximal edge segment of the band 56 that receives an adjacent portion of the distal edge segment of the band 56 as the band 56 extends and forms a three-dimensional spiral. However, the recessed portion 58 does not receive the full thickness of the distal edge segment, and thus portions of both the distal edge segment and the proximal edge segment protrude radially in opposite directions.

[0240] A plurality of posts 60 are located in the recess 58 and engage a corresponding plurality of holes 62. In the illustrated embodiment, the posts 60 are located on the proximal edge segment, with the holes 62 located on the distal edge segment. However, in other examples, these locations may be reversed. When the drive belt 56 is extended and formed into a three-dimensional spiral, the engagement of the proximal edge segment with the adjacent portion of the distal edge segment includes the engagement of the posts 60 with the holes 62. In the illustrated embodiment, the posts 60 have chamfered tip surfaces that facilitate entry and removal of the posts 60 from the holes 62.

[0241] The engagement of the posts 60 with the holes 62 axially secures together adjacent portions of the drive belt 56. The engagement of the posts 60 with the holes 62 also provides for the transfer of torque between adjacent portions of the extended belt and maintains the stability of the column formed by the extended belt.

[0242] In the illustrated embodiment, the drive belt 56 has a plurality of recesses 64 that provide a geared surface. The recesses 64 are engaged by a gear member or other suitable drive member, whereby the drive assembly can rotate the drive belt 56 by transmitting a rotational force to the drive belt 56. Figure 7 As can be seen in FIG. 5 , the drive belt 56 includes a tapered section 66 which, when formed into a three-dimensional spiral, defines a distal end of the drive belt and has a support member (such as foot 34) mounted thereto.

[0243] The illustrated drive belt utilizes a flexible polymer belt that has been machined to define the various features of the belt. Nylon, polypropylene, acetal (polyoxymethylene or POM), and high density polyethylene are examples of suitable polymeric materials that may be used to form the drive belt. Although the illustrated embodiment is machined, alternative embodiments may use a molding process to form a polymer belt having all of its features. It is envisioned that molding the belt in a flat arrangement and then rolling the belt into a two-dimensional spiral configuration will be the most efficient manufacturing method to form the belt.

[0244] Other materials may also be used to form the drive straps. For example, a thin metal strip may be used to form the straps. Photolithography, laser etching, or other suitable micromachining methods may be used to form the individual features of the straps. Alternatively, the metal straps may be formed by diffusion bonding two half-thickness layers rather than using a single metal strip.

[0245] Still other belt embodiments may take the form of an overmolded metal strip. The metal strip would be provided with distal edge features, and the overmolded plastic portion of the belt would form the various features of the belt. This approach combines the desirable hardness, elasticity, and creep resistance of metal with the low friction and ease of manufacturing of forming small features in molded plastic. It would generally be desirable for the belt to be flexible so that it can extend and retract, and withstand the attendant elastic stresses without permanent deformation.

[0246] In this regard, it should be noted that the various embodiments disclosed herein can be either single-use devices or multiple-use devices, some of which are best suited for one usage or another. Multiple-use devices will have a drive belt that can be extended and retracted multiple times so that the device can be reused with a new drug container after the drug container is exhausted. A single-use drive belt will be used with only a single drug container and, once extended, will be discarded. Such a single-use drive belt does not need to have the ability to retract after extension. The ability of the drive belt to resist axial tension and therefore axial separation in the extended portion of the drive belt during the retraction of the drive belt and when the drive belt is exposed when extended is of utmost importance. For a single-use drive belt, this concern is reduced, if not eliminated, and for at least some applications, the extended portion of the drive belt does not need to have the ability to resist axial separation forces.

[0247] Non-rotating drive belt Figures 10 to 21 The invention relates to a device with a drive belt, which does not rotate when it advances axially. This drug delivery device is suitable for use with a container, wherein the container has a container body for accommodating drugs and defining an outlet, wherein the container includes a piston arranged in the container body, and the advancement of the piston in the container body discharges the drug through an outlet (e.g., a hollow needle). The delivery device includes: a housing, which is suitable for coupling with the container; and a drive assembly, which is coupled to the housing and is suitable for advancing the piston in the container. The drive assembly includes a drive belt, which has a distal edge section and a proximal edge section. The drive belt has a retracted configuration and an extended configuration, wherein the retracted portion of the drive belt in the retracted configuration defines a two-dimensional spiral, and in the extended configuration, the extended portion of the drive belt defines a three-dimensional spiral. The drive belt can be incrementally moved from the retracted configuration to the extended configuration. The movement of the drive belt from the retracted configuration to the extended configuration defines the drive axis and advances the piston in the container body. The drive belt moves from the retracted configuration to the extended configuration without rotating relative to the housing or the container. The thrust member engages with the drive belt. The thrust member is rotatable relative to both the drive belt and the housing. Rotation of the thrust member moves the drive belt from the retracted configuration to the extended configuration.

[0248] Non-rotating drive belt with stationary thrust member In some embodiments having such a non-rotating drive belt, the thrust member is axially stationary. Such an axially stationary thrust member may include a three-dimensional helical thread engageable with the drive belt, and the device may further include a rotation restraining member, wherein the rotation restraining member is rotationally fixed relative to the housing and engages with the drive belt, and the engagement of the drive belt and the rotation restraining member prevents relative rotation of an extended portion of the drive belt and the rotation restraining member.

[0249] In such an arrangement having a rotation constraining member, one of the rotation constraining member and the extended portion of the drive belt may define an axially extending key, wherein the other of the rotation constraining member and the extended portion of the drive belt defines an axially extending keyway.

[0250] The rotation restraining member may be disposed radially outwardly of the drive belt at an engagement position where the rotation restraining member engages the drive belt to prevent rotation. Fig.10 and Fig.11 Embodiments of Fig.12 and Fig.13 Embodiments of Fig.16 and Fig.17 Embodiment of the invention.

[0251] Alternatively, the rotation restraining member may be disposed radially inwardly of the drive belt at a location where the rotation restraining member engages the drive belt to prevent rotation. See e.g. Fig.14 and Fig.15 Embodiment of the invention.

[0252] For embodiments having an axially stationary thrust member with a three-dimensional helical thread, the three-dimensional helical thread may be disposed radially outwardly of the drive band at the location where the three-dimensional helical thread engages the drive band. See e.g. Fig.10 and Fig.11 Embodiments of Fig.12 and Fig.13 Embodiments of Fig.14 and Fig.15 Alternatively, the three-dimensional helical thread may be disposed radially inwardly of the drive belt at a location where the three-dimensional helical thread engages the drive belt. See, e.g. Fig.16 and Fig.17 Embodiment of the invention.

[0253] Now turn to Fig.10 and Fig.11The embodiment of the present invention includes a rotation restraining member 68 disposed radially outward of the drive belt 70. The protrusion 72 on the rotation restraining member 68 engages an axially extending groove 73 defined in the extended portion of the drive belt 70 to define an engagement position 75. The restraining member 68 is fixed relative to the housing and the housing can also support the drug container without relative movement between the housing and the container. Therefore, the protrusion 72 prevents the extended portion of the drive belt 70 from rotating relative to the housing and the drug container. As a result, the support member or foot 74 can be fixed to the drive belt 70.

[0254] The thrust member 76 includes at least one three-dimensional helical thread 78 that engages a groove 80 forming a three-dimensional helical shape on an extended portion of the drive belt 70. When the thrust member 76 and the threads 78 rotate, they pull and guide the drive belt 70 from its retracted configuration 69 into its extended configuration 71. The threads 78 also exert an axial force on the belt 70, whereby the belt 70 can exert a biasing force on the drug container piston via the feet 74 to dispense the drug.

[0255] The thrust member 76 is axially stationary and is rotatably mounted to the restraining member 68. More specifically, the thrust member 76 is rotatable relative to the rotation restraining member 68 and is axially captured by the rotation restraining member 68 and cannot move axially relative to the rotation restraining member 68. This point is referred to as Fig.11 is best understood. The thrust member 76 includes an axially extending cylindrical section 77 on which a three-dimensional helical thread 78 is located. A radially extending flange 79 is located at one end of the section 77. The rotation restraining member 68 includes an annular groove 67 that receives the flange 79, which, once inserted into the groove 67, prevents the thrust member 76 from axially moving relative to the restraining member 68. The engagement of the thrust member 76 with the rotation restraining member 68 is a snap-fit ​​engagement, and the inclined outer radial surface 79A of the flange 79 facilitates this snap-fit ​​engagement. During the engagement of the thrust member 76 with the rotation restraining member 68, the surface 79 acts as a cam ramp that radially biases the cam 79 inward.

[0256] A drive gear or other suitable drive member engages thrust member 76, such as on outer radial surface 76A of thrust member 76, to drivingly rotate thrust member 76. For example, outer radial surface 76A may be a geared surface that engages a motor-driven gear to thereby rotate thrust member 76.

[0257] Fig.12 and Fig.13 The embodiment has Fig.10 and Fig.11 The same general structure as the embodiments. However, Fig.12 and Fig.13The embodiment of FIG. 8 differs in that the drive belt 82 has an outwardly extending projection or post 84 that engages an axially extending slot in the rotation restraining member 86 to prevent rotation of the drive belt 82. The use of the projection 84 avoids the use of axially aligned slots on the drive belt, which may be difficult to form using a roll forming process.

[0258] Fig.14 and Fig.15 The embodiment of has a drive belt 88 having grooves on its outer surface which take the shape of a three-dimensional spiral over the extended portion of the drive belt 88. The belt 88 also has grooves on its inner surface which extend axially in the extended portion of the belt.

[0259] The rotation restraining member 90 is disposed radially inwardly of the drive belt 88 and includes axially extending ribs 92 that engage grooves on the inner surface of the belt 88 to define engagement locations 93 to prevent rotation of the extended portion of the drive belt 88 .

[0260] An axially stationary thrust member 94 is disposed radially outwardly of the drive belt 88 and includes a three-dimensional helical thread 96 that engages a groove on the outer surface of the belt 88 that takes a three-dimensional helical shape on the extension of the rib 88. When the thrust member 94 rotates, it pulls the belt 88 from its retracted configuration into its extended configuration and can exert an axial force on the drive belt 88.

[0261] Fig.16 and Fig.17 The embodiment of has a drive belt 98 having an inner groove 99 defining a three-dimensional spiral shape in the extension of the drive belt and an outer groove extending axially in the extension of the drive belt.

[0262] A rotation restraining member 100 is disposed radially outwardly of the band 98 and includes ribs 102 that engage axially extending outer grooves on the band 98 to define an engagement position, thereby preventing rotation of the band 98. An axially stationary thrust member 104 is rotatably mounted on the shaft and includes a three-dimensional helical thread 106. The thrust member 104 and the thread 106 rotate and pull the band 98 into an extended configuration as they rotate. The thread 106 also exerts an axial force on the band 98.

[0263] Fig.18 and Fig.19 Two drive belts 108, 82 are schematically depicted, including radially outwardly extending protrusions that engage slots in the rotation restraining member to prevent rotation of the belts. The drive belt 82 includes a plurality of outwardly extending lugs 84 that are separated both axially and circumferentially, as shown in FIG. Fig.12 and Fig.13 It can also be seen in. Fig.18 The drive belt 108 has elongated ribs 110 which are circumferentially separated but which are substantially continuous in the axial direction for the extended portion of the drive belt.

[0264] Non-rotating drive belt with axially movable thrust member In some embodiments with a non-rotating drive belt, the thrust member moves axially in a proximal direction P as it rotates, and the distal end of the drive belt remains axially stationary as the thrust member rotates. To advance the piston within the container body, the thrust member and an extension of the drive belt move axially in a distal direction D opposite the proximal direction. Fig. 20 and Fig.21 An example of such a device is shown in . Throughout this disclosure, the use of proximal and distal orientations is consistent.

[0265] The device may also include a drive spring that is tensioned when the thrust member rotates to extend the drive belt. When the belt is extended, the thrust member moves axially in the proximal direction and the distal end of the drive belt remains stationary. To initiate dispensing of the drug, the thrust member and the drive spring are released, and the drive spring advances the thrust member axially together with the extended portion of the drive belt. The drive belt thereby advances the piston in the drug container to dispense the drug.

[0266] Fig. 20 The embodiment has an axially movable thrust member 112 including a three-dimensional helical thread 114 engageable with a drive band 124, wherein the three-dimensional helical thread 114 is disposed radially inward of the drive band 124 at a location where the three-dimensional helical thread engages the drive band. The rotation restraining member 122 is rotationally fixed relative to the housing and engages with the drive band 124, such that engagement of the drive band and the rotation restraining member prevents relative rotation of an extended portion of the drive band 124 and the rotation restraining member 122.

[0267] The threads 114 of the thrust member 112 engage the three-dimensional helical grooves on the inwardly facing surface of the drive band 124. The thrust member 112 has a hollow center that defines a central hole for receiving the central shaft 118. The thrust member 112 has a three-dimensional helical thread 116 facing its central hole that engages the three-dimensional helical grooves on the shaft 118. When the thrust member 112 rotates to move proximally on the shaft 118, it compresses the drive spring 120. Fig. 20 The thrust member is shown in its most proximal position.

[0268] The shaft 118 may extend proximally of the drive assembly more than Fig. 20, and engages a locking mechanism that prevents axial movement of shaft 118. After rotating thrust member 112 to move it in the proximal direction and compress spring 120, shaft 118 can be released, thereby also releasing thrust member 112 and spring 120. Spring 120 will then bias thrust member 112 distally, and threads 114 on thrust member 112 will cause drive spring 120 to advance distally with thrust member 112.

[0269] Fig.21 The embodiment includes an axially movable thrust member 126 including a three-dimensional helical thread 128 engageable with a drive belt 130, wherein the three-dimensional helical thread 128 is disposed radially outward of the drive belt 130 at a location where the three-dimensional helical thread engages the drive belt. A rotation restraining member 132 is rotationally fixed relative to the housing and engaged with the drive belt 130, such that engagement of the drive belt 130 and the rotation restraining member 132 prevents relative rotation of an extended portion of the drive belt 130 and the rotation restraining member 132.

[0270] and Fig.21 Compared to that shown in FIG, the thrust member 126 may extend radially outward to a greater extent so that it threadably engages the housing in a releasable manner. When the thrust member 126 is rotated relative to the housing, it will move in the proximal direction and compress the drive spring 134. Fig.21 126 is used to identify the position of the thrust member 126 after it has been rotated to retract the thrust member proximally. After retracting the thrust member 126, the thrust member can be released, which will also release the drive spring 134, whereby the spring 134 will cause the thrust member 126 to advance axially in the distal direction. The threads 128 on the thrust member 126 will cause the drive band 130 to advance axially in the distal direction with the thrust member 126, and thereby advance the drug container piston to dispense the drug.

[0271] Rotatable drive belt Figures 22 to 45A drive belt that rotates as it is advanced axially. Such a belt may be employed in a drug delivery device for use with a container having a container body containing a drug and defining an outlet, wherein the container includes a piston disposed within the container body, and advancement of the piston within the container body discharges the drug through the outlet. The delivery device includes: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container. The drive assembly includes a drive belt having a distal edge segment and a proximal edge segment. The drive belt has a retracted configuration and an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral. The drive belt may be incrementally movable from the retracted configuration to the extended configuration, and the movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis. The drive belt rotates as it moves from the retracted configuration to the extended configuration.

[0272] Figure 22 to Figure 24 A device is provided in which a drive member is arranged radially inside a drive belt to engage and rotate the drive belt, and a fixing component having a three-dimensional helical thread is arranged radially outside the drive belt. The three-dimensional helical thread of the fixing component engages the drive belt and controls the movement of the drive belt between a retracted configuration and an extended configuration.

[0273] Fig. 22 An assembly is illustrated in which the drive member 136 has a pair of keys 138 that engage grooves on the inwardly facing surface of the drive band 140 to drivingly rotate the band 140. The collar 142 is fixed relative to the housing and includes a three-dimensional helical thread 144 that engages the three-dimensional helical grooves on the outwardly facing surface of the drive band 140.

[0274] Fig.23 and Fig.24 The diagram shows Fig. 22 1 is a very similar assembly to that shown in , but wherein the drive member 146 has a greater number of keys 148 to engage a correspondingly greater number of grooves on the inner surface of the drive band 150 to define the engagement position.

[0275] Because the drive belt 150 rotates as it is advanced axially, a rotatable bearing assembly 152 is employed having a first member 154 fixed to the drive belt 150 and a second member 156 that can rotate relative to the member 154 and the belt 150. The second member 156 can directly bear against the piston of the drug container without rotating relative to the piston, while the first member 154 and the belt 150 both rotate relative to the member 156 and the piston when the belt is advanced and biases the member 156 against the piston to advance the piston.

[0276] Fig.25 and Fig.26Alternative drive arrangements are illustrated which are disposed radially within the drive belt to engage and rotate the drive belt. Fig.25 The use of a single gear member 158 is shown, while Fig.26 The use of multiple gears 160 is shown. The gears 158, 160 will engage axially extending grooves or raised ribs (not shown) on the inner surface of the drive belt. Such grooves / ribs will be spaced apart a distance corresponding to the distance between gear teeth on the gears used with the belt.

[0277] Figures 27 to 41 Embodiments are directed to having a rotatable drive belt wherein a drive member disposed radially outwardly of the drive belt engages and drivingly rotates the drive belt.

[0278] Fig. 27 A single ring gear 162 is schematically depicted for use with a drive belt 164. The ring gear 162 completely surrounds the drive belt 164 and engages a portion of the outer surface of the drive belt 164. The central opening of the ring gear 162 is larger than the outer diameter of the drive belt 164, and therefore, a portion of the outer circumference of the drive belt is not engaged by the ring gear 162. Fig.28 and Fig.29 The use of multiple ring gears is schematically depicted. In the illustrated embodiment, two ring gears 166 engage the drive belt 164. The use of two ring gears 166 allows the entire outer circumference of the drive belt 164 to be engaged by the ring gears. Fig.29 As can be seen in FIG. 1 , the ring gear 166 is axially offset. Fig.29 The device also includes a spindle member 168 having three-dimensional helical threads 170 that engage grooves on the inner surface of the drive belt 164. The ring gear 166 is advantageously axially positioned so that the ring gear 166 engages the outer surface of the drive belt proximate to where the threads 170 engage the inner surface of the drive belt.

[0279] Various other types of drive members may alternatively be employed to drivingly rotate the drive belt. Fig.30 The use of a belt drive arrangement is schematically depicted, wherein a belt 172 engages the outer surface of a drive belt 174 to rotate the drive belt. A driven shaft 176 or other suitable mechanism drives the belt 172.

[0280] Multiple planetary gears may also be used to rotate the drive belt. Fig.31 Depicted is the use of planetary gears 178, which are also reduction gears, and Fig.32 and Fig.33 A slightly different embodiment is depicted in which the planetary gears 180 are not reduction gears. Fig.33As can be seen in FIG. 1 , the three-dimensional helical thread 182 engages the inwardly protruding proximal edge of the drive belt 184, while the planetary gear 180 engages the outer surface of the drive belt 184. Figures 7 to 9 Similar to the drive belt of , drive belt 184 has outwardly projecting edges where the drive belt engages itself.

[0281] Fig.34 and Fig.35 An alternative drive arrangement is depicted which employs a worm gear to rotate the drive belt. Fig.34 In the embodiment of the present invention, a pair of worm gears 186 engage the outer surface of a drive belt 188 to rotate the belt 188. Fig.35 A drive arrangement is depicted in which a single worm gear 190 is used to rotate the drive belt 188. While using a single worm gear will reduce the complexity and number of parts compared to using two worm gears, using a pair of worm gears disposed on opposite sides of the drive belt provides a more balanced force distribution on the drive belt.

[0282] Figure 36 to Figure 41 Involves the use of a key drive to drive a rotating drive belt. Fig.36 A drive belt 192 is depicted having a plurality of splines or ribs 194 that extend axially when the drive belt 192 is in an extended configuration. The ribs 194 may be engaged by splines or slots on a drive member to drivingly rotate the belt 192. Fig.37 A drive band 196 is depicted having a plurality of keyways or slots 198 that extend axially when the drive band 196 is in an extended configuration. The slots 198 may be engaged by a key or similar protrusion on a drive member to drivingly rotate the band 196.

[0283] Fig.38 and 39 An example of a key drive arrangement is depicted. Fig.38 and Fig.39 In the embodiment of the present invention, the drive member 200 has a plurality of ribs or keys 202 that engage axially extending grooves on the outer surface of the drive belt 204. When the drive member 200 rotates, the drive belt 204 also rotates. The stationary spindle member 206 has a three-dimensional helical thread 208 that engages the grooves on the inner surface of the drive belt 204.

[0284] Fig.40 and Fig.41 Another example of a key drive arrangement is depicted. In this arrangement, a drive member 210 includes a plurality of ribs or keys 212 that engage axially extending grooves on the outer surface of a drive band 214 to drivingly rotate the band 214. A stationary collar member 216 includes a three-dimensional helical thread 218 that engages grooves on the outer surface of the drive band 214.

[0285] The non-engaged portion of the drive belt is engaged by the drive member Figure 42 to Figure 45 A drug delivery device for use with a container having a container body containing a drug and defining an outlet. The container includes a piston disposed in the container body, wherein the advancement of the piston in the container body discharges the drug through the outlet. The delivery device includes: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston in the container. The drive assembly includes a drive belt having a distal edge segment and a proximal edge segment. The drive belt has a retracted configuration and an extended configuration, wherein in the retracted configuration, the retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration, the extended portion of the drive belt defines a three-dimensional spiral. The drive belt is incrementally movable from the retracted configuration to the extended configuration. The movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis and advances the piston in the container body. The drive belt rotates when it moves from the retracted configuration to the extended configuration. The drive belt also defines a transition portion disposed between the retracted portion and the extended portion, wherein the distal edge segment and the proximal edge segment of the drive belt are not joined together in the transition portion. The drive member engages the drive belt and drivingly rotates the drive belt, and the drive member engages a retracted or transition portion of the drive belt.

[0286] Storage tube drive component Fig.42 A device is depicted that includes a storage barrel 220 that accommodates a retracted portion of a drive belt 222. The portion of the drive belt 222 disposed within the storage barrel 220 expands radially outward to engage the storage barrel 220. Thus, when the storage barrel 220 rotates, the drive belt 222 also rotates. This can be used to force the drive belt 222 to engage with the collar member 224. The collar member 224 includes a three-dimensional helical thread 226 that engages a groove on the outer surface of the drive belt 222 to control and guide the belt 222 to engage with itself, thereby extending the belt 222 axially. It should be noted that rotation of the barrel 220 in the opposite direction can be used to retract the belt 222. Similarly, for almost all of the drive member mechanisms disclosed herein, unless otherwise specifically stated, the drive member mechanism can be operated in reverse to retract the drive belt and extend it.

[0287] Reciprocating drive components Fig.43 A reciprocating drive member 228 is shown engaging the drive belt 230 in a transition portion 231 of the drive belt (between the retracted portion and the extended portion). Fig.43As can be seen in the figure, the reciprocating drive member 228 engages the radially inwardly facing surface of the drive belt 230. For some embodiments of the drive member 228, the cyclical motion of the member 228 and the nature of its engagement will result in the member 228 being able to drive the belt 230 into its extended position, but not being able to drive the belt 230 into its retracted position.

[0288] Worm gear Fig.44 An embodiment is depicted in which the worm gear 232 engages the drive belt 234 in the retracted portion of the drive belt.

[0289] Reciprocating ratchet drive Reference now Fig.45 For embodiments having a reciprocating drive member, the reciprocating drive member 236 may take the form of a drive member that moves in a first direction and an opposite second direction (as depicted by double arrow 242). The drive member 236 is shown to include at least one flexible ratchet member 244 engageable with the drive belt 238, the flexible ratchet member being configured to allow relative movement between the drive member 236 and the drive belt 238 in a first direction 243 and not allow relative movement between the drive member 236 and the drive belt 238 in a second direction 241 (or to allow one-way movement). When moving in the second direction 241, the drive member 236 will push the drive belt and thereby cause the drive belt 238 to move. When moving in the first direction 243, the ratchet member 236 will be repositioned on the drive belt 238, whereby when moving again in the second direction 241, the ratchet member can push the belt forward. The illustrated embodiment also includes a stationary ratchet member 240 that does not move relative to the housing and includes a plurality of ratchet members 244 that engage a radially outwardly facing surface of the drive belt 238. The ratchet members 240 will ensure that the drive belt 238 is not pulled rearwardly by the reciprocating ratchet members 236 when the reciprocating drive member 236 moves in the first direction 243. Fig.45 The ratchet drive depicted in is well suited for use in a single-use device, where the belt is extended but not subsequently retracted. If it is desired to use such a ratchet drive in a multiple-use device, the ratchet members 236 and 240 would have to be movable away from the drive belt and a second drive mechanism would be employed to rotate the drive belt in the opposite direction. To generate the reciprocating motion of the drive member 236, as well as the drive member 228 discussed above, an oscillating escapement drive may be employed.

[0290] Device Architecture The various belt and drive member mechanisms disclosed herein can be combined in many ways to provide a drug delivery device.Two general categories of such devices include devices having an in-line architecture and devices having a dual-axis architecture. Figures 46 to 54The two basic architectures are depicted in .

[0291] Inline architecture Figure 46 to Figure 48 24 shows an arrangement having an in-line architecture. In this arrangement, both the drive belt R and the extended drive member mechanism for driving the drive belt share a common axis 246. Fig.46 As shown in , the device includes: a dial knob DK, which is used to set the dose; and an injection button B, which activates the extension of the drive belt. The device also contains a drug container 248. The illustrated container 248 is a conventional syringe cartridge having a glass tube containing the drug, a piston 250 disposed in the tube, and an outlet defined by a hollow injection needle 252. When the drive belt R is extended, a support member 254 disposed on the distal end of the belt R supports against the piston 250 to advance the piston 250 in the container 248 and thereby discharge the drug through the needle 252.

[0292] Dual-axis architecture Figure 49 to Figure 54 A simplified depiction of a dual axis device is provided. Figure 55 to Figure 132 A more detailed schematic image of the dual axis device is provided, and Fig.132 The following figures provide even further representations of the dual axis device. Throughout the accompanying drawings, references to common components (such as, needle 252, container 248, dial knob DK, drive belt R and injection button B) will be used for different device configurations. As will become apparent from the following discussion, the dual axis device includes a main drive axis defined by the drive belt, and also includes a drive member mechanism that defines a secondary axis parallel to the main drive axis and offset therefrom. An advantage of the dual axis device is that the drive member mechanism can be positioned to extend parallel to the main axis in the distal direction by offsetting a portion of the drive member mechanism from the main axis. This allows such a dual axis device to have an overall shorter length relative to the situation where the entire drive member mechanism is positioned to align with the main axis.

[0293] As in Figure 49 to Figure 54 As can be seen in FIG, the dual-axis architecture can increase the volume of the device (referred to herein as 253) over a relatively short portion of the length of the device, which can be beneficial to patient users who have dexterity or handling challenges due to debilitating diseases or conditions. Figures 49 to 51 The device 253 depicted in is for dispensing medication from a conventional 3 ml syringe cartridge and has a drive belt defining a first primary axis 254 and a drive member mechanism defining a secondary parallel axis 256. Similarly, Figure 52 to Figure 54The device depicted in (referred to herein as 253') also dispenses medication from a conventional 3 ml syringe cartridge and has a drive belt defining a first primary axis 254 and a drive member mechanism defining a secondary parallel axis 256. The housings of the two components (cartridge / drive belt portion and drive member mechanism component portion) may have different housing configurations.

[0294] These devices and Figure 55 to Figure 132 Both of the devices depicted in are drug delivery devices for use with a container having a container body containing a drug and defining an outlet. The container includes a piston disposed in the container body, wherein the advancement of the piston in the container body discharges the drug through the outlet. The delivery device includes: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston in the container. The drive assembly includes a drive belt having a distal edge segment and a proximal edge segment. The drive belt has a retracted configuration and an extended configuration, wherein the retracted portion of the drive belt defines a two-dimensional spiral in the retracted configuration, and the extended portion of the drive belt defines a three-dimensional spiral in the extended configuration. The drive belt is incrementally movable from the retracted configuration to the extended configuration. The movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis and advances the piston in the container body. A drive member mechanism is operably coupled to the drive belt and defines a secondary axis parallel to the drive axis. The drive member mechanism generates a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0295] Several embodiments of such a dual axis device will now be discussed. Various embodiments include several illustrated examples such as Figures 55 to 78 as well as Figures 97 to 114 Examples such as those depicted in , which have a drive member mechanism comprising a spring S aligned with the secondary axis, wherein setting a dose comprises tensioning the spring S and releasing the tension from the spring S to generate a force that is transmitted to the drive belt R to move the drive belt from a retracted configuration to an extended configuration.

[0296] Several of the illustrated dual axis embodiments (such as, Figure 79 to Figure 96 Dual-axis embodiments such as those depicted in ) have a drive member mechanism including a plunger disposed along a secondary axis, wherein linear translation of the plunger generates a force that is transmitted to the drive belt R to move the drive belt from a retracted configuration to an extended configuration.

[0297] There are others among the illustrated dual axis embodiments (such as Figures 115 to 132) have a drive member mechanism including an electric motor M drivingly coupled to an element disposed along the secondary axis, the electric motor M generating a force that is transmitted to the drive belt R to move the drive belt from a retracted configuration to an extended configuration. In such an embodiment, the element disposed along the secondary axis may be a drive shaft of the electric motor.

[0298] In some of the illustrated embodiments, such as Figure 55 to Figure 102 In the embodiment of the invention, the drive belt R and the drive member mechanism are disposed within the housing and the container 248 is not removable from the housing, whereby these devices form a single-use or disposable pre-filled device. However, modifications to such a device may make it suitable for multiple-use applications. Alternatively, the device may have a more modular architecture, such as Figures 103 to 136 The architectures depicted in .

[0299] Now go to Figures 55 to 60 , which comprises a primary axis 254 and a secondary axis 256. A dial knob DK on the secondary axis is used to set a dose, and a torsion spring S is tensioned by means of a ratchet mechanism (dial ratchet) DR which rotates a sleeve SL and a torsion spring S. The sleeve SL is coupled to an injection button B, and when the injection button is pressed, the sleeve is displaced, thereby releasing the spring. When the spring S is released, it rotates an output sleeve 258, which has an output ratchet O disposed thereon. The output ratchet O in turn rotates a drive belt R. The output ratchet O engages a drive member which in turn engages and rotates either the belt or (if a non-rotating belt is used) a thrust member (such as that previously described). Rotation of the drive belt or thrust member causes the belt to extend axially and thereby advance the piston and dispense drug from the cartridge. The threaded member IRD is a "counter IRD" which acts as a low dose remaining indicator and prevents further rotation of the sleeve SL and therefore the dial knob DK after the member IRD has travelled the thread length of the sleeve SL which is sized to correspond to the amount of drug in a 3 ml cartridge. Fig.59 The device 253 is illustrated when the dial knob DK is rotated to tension the torsion spring S (also referred to as the dial configuration) and set a dose. Rotation of the dial knob DK in turn rotates a dose indicator dial 259 which may be visible through a window W defined by the housing to provide an indication of the dialed amount. Fig.60 The device 253" is illustrated during an injection procedure after a button is pressed by a user to release the spring S which rotates the sleeve 258.

[0300] Figure 61 to Figure 66 The device 253A" depicted in Figures 55 to 60 is similar to the device depicted in Figure 61 to Figure 66The dial knob DK of the embodiment of is located on the proximal end of the device with the injection button B rather than the distal end. Rotation of the dial knob DK rotates the inner sleeve SL by means of the dial ratchet 261. Fig.65 The device 253A" is shown placed in a dial configuration to set a dose. Fig.66 The device 253A" is illustrated during an injection procedure after a button is pressed by a user.

[0301] Figures 67 to 72 The device 253'' depicted in the figure has a drive belt R defining a primary axis 254 and a drive mechanism centered on a secondary axis 256. The drive member mechanism includes a dial knob DK that is rotated by the user to set the dose. Rotation of the dial knob DK rotates the internal sleeve SL by means of a dial ratchet 261. When the sleeve SL rotates, it tensions the torsion spring S. Pressing the injection button B moves the shifting member 260, which shifts the sleeve and thereby releases the torsion spring. When the torsion spring is released, it rotates the output sleeve 262. The output sleeve 262 has an output ratchet O arranged thereon, which drives the belt assembly when the output sleeve 262 rotates. The input sleeve includes a threaded section, on which the threaded member IRD (remaining dose insufficient) is located.

[0302] Figure 73 to Figure 78 The device 253"" depicted in FIG. 1 also includes a displacement member 264 to initiate dispensing of the drug during an injection procedure, but it is in the same manner as Figures 67 to 72 The embodiments are constructed in different ways. Figure 73 to Figure 78 The embodiment includes a dial knob DK for setting a dose. Rotation of the dial knob DK rotates the sleeve SL by means of the dial ratchet 261. When the sleeve SL rotates, it tensions the torsion spring S. The displacement member 264 also defines the injection button B, and when the displacement member 264 is moved from Fig.77 The dial dose setting position shown in Fig.78 , it releases the torsion spring S. When released, the torsion spring S rotates the output sleeve 266. The output ratchet member O on the output sleeve 266 then drives the belt assembly to extend the drive belt R, advance the piston and dispense the drug. The threaded member IRD (remaining dose insufficient) is provided on the threaded section of the sleeve that is rotated by the dial knob.

[0303] Figures 55 to 78 The embodiment depicted in does not experience a change in length when setting a dose or when extending the drive belt, with the limited exception that when an injection button is provided on one end of the device and the button is pressed to actuate an injection procedure, the movement of the injection button causes the length to change by an insignificant amount. In contrast, Figure 79 to Figure 96The device depicted in and described further below includes plungers that extend from the device and increase the length of the device when setting a dose, and are subsequently manually depressed to return them to their original position providing a driving force to extend the drive belt, advance the piston within the drug container, and dispense the drug.

[0304] Figure 79 to Figure 84 The device 263 depicted in FIG. 2 has a dial knob DK for setting a dose. When the dial knob DK is rotated, a dial clicker in the form of a one-way ratchet mechanism 261 rotates the sleeve SL. When the sleeve SL rotates, the plunger PL extends out of the housing in a proximal direction due to the threaded engagement of the sleeve and the plunger to place the device in a position such as Fig.83 When the plunger PL is manually depressed to force it back into the housing in the distal direction to place the device in the dial dose setting configuration shown in FIG. Fig.84 In the injection dose delivery configuration shown in , the sleeve SL rotates in the opposite direction and causes the output sleeve 268 to rotate with it. The plunger PL does not rotate when extended or pressed. In order to prevent the plunger PL from rotating, the rod of the plunger can have a non-circular cross-section that passes through the corresponding opening in the housing. The output ratchet O on the output sleeve then transmits the rotational force to the drive member, which rotates the drive belt R or the thrust member to advance the piston axially and discharge the medicine.

[0305] Figures 85 to 90 The device 263' depicted in Figure 79 to Figure 84 The device depicted in is similar, but the dial knob DK has been relocated to the proximal end of the housing. Each of these embodiments may also include a threaded member IRD (remaining dose insufficient) provided on the threaded section of the sleeve.

[0306] Figure 91 to Figure 96 The device 263" depicted in FIG. 2 has an extendable plunger, wherein several components of a drive assembly centered about a secondary axis 256 extend with the plunger when a dose is set and move with the plunger when the plunger is depressed. A dial knob is used to set a dose. When the dial knob DK is rotated, it rotates a dial sleeve 270 and a plunger rod 274. The plunger rod 274 is threaded and engages with a threaded opening 276 provided on an inner portion of the housing. When a dose is set, rotation of the plunger rod 274 relative to the opening 276 causes the plunger rod 274 to extend out of the housing in a proximal direction, as shown in FIG. Fig.95 , while the sleeve 270 is rotationally decoupled from the plunger rod 274, but travels axially with the dial sleeve 278 and the plunger rod 278. Depressing the injection button B causes the plunger rod 274 to rotationally engage the sleeve 270, which is rotationally engaged with the output sleeve 272. When the dial assembly is pressed distally back into the housing, it rotates, causing the output sleeve 272 to also rotate, as shown in FIG. Fig.96 As shown in . When the output sleeve 272 rotates, the output ratchet O on the output sleeve 272 rotates the output shaft. The output shaft in turn rotates the drive member or thrust member to extend the drive belt R, advance the piston, and discharge the drug.

[0307] Modular architecture Figures 97 to 102 The device 283 depicted in has a modular architecture in which a detachable electronic module has an injection button that can be attached to a cartridge unit having a drug container, a drive belt, and a drive assembly. The electronic module can be reused multiple times with different cartridge units having the same basic structure. Such cartridge units can also be disposable units.

[0308] Figures 97 to 102 The device depicted in has a reusable electronic module 280 that can be detachably connected to a cartridge unit 282. The cartridge unit 282 includes a drug container 248 containing a drug and having a piston, wherein advancement of the piston in the drug container dispenses the drug through an injection needle 252. A drive belt R is used to advance the piston and defines a primary drive axis 254. The illustrated cartridge unit 282 also includes a drive member mechanism centered around a secondary axis 256. The illustrated cartridge unit 282 is a single-use cartridge that is disposed of after the drug is exhausted.

[0309] The dial knob DK is used to set the dose. The rotation of the dial knob DK rotates the sleeve SL with the aid of the dial ratchet 261. The rotation of the sleeve SL tensions the torsion spring S. Fig.101 Move to the position shown in Fig.102 In the position shown in FIG. 1 , the arm 285 of the button B engages the sleeve SL and allows the sleeve SL to be displaced axially and thereby release the torsion spring S. When the display is removed, an injection cannot be initiated. When released, the torsion spring S causes the output sleeve 284 to rotate. The rotation of the output sleeve 284 is transmitted to the belt assembly and extends the drive belt R to thereby advance the piston and expel the drug. When the injection button B is in Fig.101 , the sleeve SL is in an axial position that prevents the torque from being transmitted from the torsion spring S to the output sleeve 284 and thereby prevents the torsion spring S from advancing the drive belt R. When the electronic module 280 is removed from the cartridge unit 282, the sleeve S remains in the Fig.101 , and therefore when the electronic module 280 is removed, the torsion spring S will not advance the drive belt R.

[0310] Figures 103 to 136Embodiments of the invention also have a modular architecture. However, the reusable module of these embodiments includes a drive member mechanism centered on the secondary axis, thereby allowing a greater percentage of the total assembly to be reused. The drive member mechanism is disposed within the housing, and the device also includes a cartridge housing, wherein the drive belt is disposed within the cartridge housing and the container is mounted on the cartridge housing, wherein the cartridge housing is removably securable to the housing.

[0311] exist Figures 103 to 108 as well as Figures 109 to 114 In the embodiment depicted in , the device has a drive member mechanism comprising a spring aligned with the secondary axis, wherein setting a dose comprises tensioning the spring and releasing the tension from the spring to generate a force that is transmitted to the drive belt to move the drive belt from a retracted configuration to an extended configuration.

[0312] More specifically, Figures 103 to 108 The device 293 depicted in FIG. 1 includes a cassette 286 having a cartridge housing 286A and a reusable module 288 having a main housing 288A. Fig.103 As can be seen in FIG. 2 , the drive belt R is disposed in the cartridge housing 286A, and the cartridge 148 containing the drug is mounted on the cartridge housing 286A. Fig.103 It can also be seen that the drive member mechanism 290 that drives the axial advancement of the drive belt R is arranged in the main housing 288A and is centered on the secondary axis 256.

[0313] The depicted device 293 includes a dial knob DK for setting a dose. Rotation of the dial knob DK rotates the sleeve SL by means of the dial ratchet 261. As the sleeve SL rotates, the torsion spring S is tensioned. When the injection button B is pressed, the sleeve SL is displaced and the torsion spring S is released. When released, the torsion spring S rotates the output member 292, which in turn rotates the drive member 294 engaged with the drive belt R to thereby extend the drive belt. A dial 297 is provided between the sleeve SL and the spring S and is used for dose tracking together with the interlock 295.

[0314] Reusable module 288 includes an electronic module (not shown) coupled to a display. Interlock 295 provides an electrical signal, which is used by the electronic module to determine whether reusable module 288 is attached to box 286. The sensor senses the rotational movement of sleeve SL, and provides data on the amount of medicine to be dispensed to the electronic module based on the extent to which the sleeve has been rotated due to the rotation of the dial knob DK. Interlocks may be configured to zero the device by resetting the position of dial 297 when removing the box. Box 286 may include an RFID (radio frequency identification) chip to identify the contents of the drug container. Advantageously, the RFID chip is read / written, so that the electronic module on the reusable module 288 can record data related to the amount of medicine dispensed from box 286 after each injection procedure, so that the module will be able to determine the remaining amount of the medicine in the box. Alternatively, box 286 may have a read-only RFID tag and another form of digital memory to record such data. By recording data about the type and amount of medication on the cartridge, the cartridge 286 can be removed from the reusable module 288 before it is completely exhausted, and then subsequently reattached with the electronic module, which is able to read the data about the medication identification and amount remaining when the cartridge is reattached. This will allow the electronic module to accurately track the amount of medication remaining and generate an IRD (Insufficient Remaining Dose) message, even when the cartridge has been detached when partially emptied and then subsequently reattached.

[0315] Figures 109 to 114 The device 293" depicted in Figures 103 to 108 The device shown in is similar to that shown in , but has a different reusable module 298, wherein the dial knob DK is located on the distal end of the reusable module 298 rather than the proximal end. The dial knob DK is used to set the dose, and the rotation of the knob rotates the sleeve SL by means of the dial ratchet 261. The rotation of the sleeve SL tensions the torsion spring S. Pressing the injection button B releases the spring S, which then rotates the output member 296. The rotation of the output member 296 drives the extension of the drive belt R. Similar to the module 288, the module 298 includes an electronic module that is coupled to the display and can communicate with the box to identify the contents and remaining amount of the box.

[0316] The reusable module may alternatively have an electric motor instead of a spring driven member mechanism. For example, Figures 115 to 120 ; Figures 121 to 126 ;as well as Figures 127 to 132 The embodiments depicted in each have a drive member mechanism including an electric motor drivingly coupled to an element disposed along the secondary axis, the electric motor generating a force that is transmitted to the drive belt to move the drive belt from a retracted configuration to an extended configuration. For example, the motor shaft can be an element disposed along the secondary axis and defining the secondary axis.

[0317] Figures 115 to 120 The device 303 depicted in FIG. 2 includes a reusable module 300 having an electric motor M that can be coupled to the cartridge 286. The motor M includes a motor shaft 304 that rotates a drive element 302 that in turn rotates the drive member 294 of the cartridge to extend the drive belt R. Figures 115 to 120 , the drive belt R extends axially without rotating. The cartridge housing member 287 serves as a rotation restraining member and includes an axially extending projection (not shown here but previously described) to prevent the drive belt R from rotating. The drive member 294 serves as a thrust member and includes a three-dimensional helical thread that engages and axially drives the drive belt R. The drive member 294 is axially captured by the housing member 287 within an annular groove that allows the drive member 294 to rotate but prevents axial movement of the drive member 294. The outer radial surface of the drive member 294 protrudes outward from the cartridge (as in Fig.119 The drive element 302 defines a cooperating geared surface for engaging the drive member 294 and rotatably driving the drive member 294.

[0318] The electronic module may be used to control the operation of the motor. The dial knob DK may be used to generate a signal to the electronic module to define the dose, and the injection button B communicates with the electronic module to start the operation of the motor. Fig.116 As can be seen in FIG, the dial knob DK is located on the distal end of the module 300, while the injection button B is located on the side of the module 300 that is farthest from the cartridge 248 of the box 286 and is close to the dial knob DK. The electronic module can also communicate with the box 286 as described above to identify the contents of the cartridge 248 and determine the amount of drug remaining in the box.

[0319] Figures 121 to 126 The device 303' depicted in has a reusable module 306 that can have a box 286 attached thereto. Module 306 has an electric motor M and has the same general functions as module 300. A motor shaft 308 extends from motor M, and a drive element 310 is mounted on shaft 308. When motor M is energized, drive element 310 engages and rotates drive member 294 on box 286. Module 306 differs from module 300 in that it includes a proximal foot 312. Foot 312 is positioned adjacent to the proximal end of box 286 and has an injection button B mounted thereon. Foot 312 helps prevent accidental displacement of box 286 and provides a more secure attachment to box 286. It also allows injection button B to be placed on the drive axis 254 defined by the drive belt. Due to its similarity to a syringe with an in-line manual plunger, some users may find this placement more intuitive and comfortable.

[0320] Figures 127 to 132 The device 303" depicted in FIG. 3 has a reusable module 314 similar to module 306, with the only difference being that module 314 uses input buttons 316 to set the dose instead of a dial knob. As shown, one of the input buttons 316 is used to increase the dose, and another of the input buttons 316 is used to decrease the dose. A display may be used to indicate a change in dose as a result of using the input buttons.

[0321] In any of the reusable modules having an electric motor M and / or an electronic module described herein, the reusable module may include a single-charged disposable battery or a rechargeable battery (in Fig.127 313) for powering the electric motor and the electronic module and / or box 286'. The electronic module described herein (shown as battery 313) in electrical communication with the module and the box Fig.127 The electronic module 315 (representatively shown in FIG. 1 ) is configured to control the operation of the module and the box and may include a processor or similar microcontroller and a transceiver or alternative communication hardware.

[0322] Instead of rechargeable batteries, the reusable modules described herein may employ disposable batteries, or alternatively, may include a small disposable battery in each cartridge, rather than an onboard battery on the module, that is sized to provide sufficient energy to the electric motor M to empty the contents of the cartridge. In this regard, it should be noted that Fig.131 A box 286' is schematically depicted having a battery 317 for powering a reusable module. When the battery or other power source is positioned in the box 286', electrical contacts 319 on the box and electrical contacts 321 on the module ( Fig.132 ) will engage when the box and module are connected to thereby transfer power from the box to the module. Such cooperative electrical contacts on either the box and the reusable module described herein can also be used to provide communication or power conduits between the electronic circuits on the box and the reusable module.

[0323] As reference Figures 133 to 136 As best understood, for an embodiment having a reusable module and a box having a cartridge housing, the device may also include a plurality of cartridges, each cartridge including a cartridge housing having a drive belt disposed within the cartridge housing and a container mounted on the cartridge housing, each of the cartridges being capable of being interchangeably and removably secured to the housing of the reusable module.

[0324] In addition, as discussed above with respect to a single box, in those embodiments with multiple cartridges, an electronic module may be disposed on the housing of a reusable module, and each of the multiple cartridges may also include a digital memory device, such as a read / write RFID or other form of digital memory (e.g., internal flash memory or onboard EEPROM). The electronic module of the reusable module will establish communication with the digital memory device of the cartridge (the cartridge is coupled to the housing), and after the injection procedure is completed, the electronic module records data related to the injection procedure on the digital memory device. In such embodiments, the data recorded on the digital memory device may include data related to the amount of the drug remaining in the container. In such embodiments, the multiple cartridges may all contain the same drug, or they may contain a variety of different drugs.

[0325] Fig.133 Drug delivery system 3170 is illustrated, it comprises box 286, second box 318 and reusable module 3190, this reusable module can be detachably fixed to box 286, thus module 3190 can drive the extension of drive belt in box 286 to distribute medicine.Second box 318 can be identical with box 286, except that it is not yet fixed to the needle assembly of the far end of medicine container.The ability of box 286 and 318 being exchanged with single reusable module 3190 has several advantages.For example, if patient potentially needs to inject two different medicines in the process of one day, then box 286 and 318 can hold two different medicines, and patient only needs to carry single module 3190 just can be used with two different boxes, thereby compact system is provided.In addition, box 286 and 318 can be provided with read / write RFID or read-only RFID and digital memory, thus patient can exchange box as needed, and this module will still be able to identify the medicine contained in the attached box and the amount remaining in the box, as discussed above. Alternatively, if the patient only requires a single medication, they may still find it convenient to carry module 3190 and two cartridges 286 and 318 containing the same medication, with the second cartridge serving as a backup supply in case the first cartridge becomes depleted or needs to be replaced for some other reason.

[0326] Fig.134 Also illustrated is how module 3190 can be used with multiple cartridges of different drugs in drug delivery system 331. Fig.134In the embodiment of the present invention, box 320 and 322 all have the same structure as box 318. The only difference between box 320 and 322 is that box 322 contains different medicines from box 320. Although the RFID of these boxes will identify the medicine contained in the box and this information can be displayed for the user to see on the display of reusable module 3190, the box that holds different medicines can also be advantageously identified by visual inspection. For example, the box 320 that all holds the same type of medicine can advantageously have the cartridge housing of the same color, while the box 322 that holds different medicines has the cartridge housing of different colors. The printed label of the content of the identification box can also be adhered to the box.

[0327] exist Figure 133 to Figure 134 In an embodiment of the present invention, each of the boxes 286, 318, 320, 322 may have a digital memory device 323, which includes data on the type of drug contained in the cartridge and the remaining amount of the drug. Other data (such as manufacturing date, serial number) may also be recorded on the digital memory device 323. Module 3190 includes an electronic module 329, which utilizes a controller that controls the operation of the module and the box. The electronic module 329 also communicates with the digital memory device 323 of the box engaged with the module 3190 to obtain information on the type of drug and the remaining amount of the drug in the box.

[0328] Figure 133 to Figure 134 Also shown in the figure are electrical contacts 325 on boxes 286, 318, 320, 322 and cooperating electrical contacts 327 on module 3190. When the box is installed on module 3190, the cooperating contacts 325, 327 are engaged to provide electrical communication therebetween for data signal transmission and / or power supply. The use of contacts 325, 327 allows the electronic module 329 of module 3190 to communicate with the digital memory device 323 in a hardwired manner. Alternatively, the electronic module 329 can communicate with the digital memory device 323 wirelessly, and contacts 325, 327 can be used to confirm that the box has been successfully docked on module 3190. For example, when contacts 325, 327 are not engaged, the circuit with contacts 325 on module 3190 can be disconnected. Then, when the box is installed on module 3190, contacts 327 will engage with contacts 325 and close the circuit where contacts 325 are located. The electronic module 329 can monitor whether the circuit having contacts 325 is open or closed to thereby determine whether the box has been installed to the module 3190.

[0329] Fig.135 and Fig.136 Depicted are systems 333 and 335, respectively, which are Fig.133 and Fig.134317, 331 in the system, but with a reusable module 324, which is different from the module 3190 in that the module 324 includes a foot 312 similar to the module 306. Otherwise, the reusable module 324 functions the same as the module 3190 and can be used with the boxes 286, 318, 320 and 322 in the same manner as discussed above with respect to the module 3190.

[0330] It should be noted that the reusable module and the cartridge can track the remaining amount of the drug in the cartridge in various ways. As mentioned above, the remaining amount can be tracked by having the reusable module monitor the set dose and / or the mechanical output delivered to the cartridge to determine the amount of drug dispensed during each injection procedure. The original amount of drug contained in the drug container is known, and therefore by subtracting the dispensed amount, the remaining amount can be tracked and monitored.

[0331] Alternatively, the extent to which the drive belt has been extended axially can be monitored to determine the remaining amount. For example, the drive belt may be provided with a mark that can be read by an optical sensor. The optical sensor is positioned to sense the mark on the extended portion of the drive belt, and for a device with a modular architecture, it may be positioned on a box or a reusable module, wherein a window in the housing allows the optical sensor to observe the extended portion of the drive belt. The sensor may count the number of passes of the same mark or may be able to discern different marks to determine the extent to which the drive belt has been extended axially. By tracking the length of the drive belt that has been extended axially and knowing the size of the drug container, the amount of remaining drug can be determined. In this regard, it may be necessary to initially determine the length reached by the drive belt extension to initially engage the piston without dispensing the drug. The extension of the drive belt after reaching its initial contact point can be easily converted into the amount of drug dispensed for a conventional drug container with a known size.

[0332] Figures 137 to 145 An example of a reusable drive member mechanism module and a cartridge having a cartridge housing and a drive belt disposed in the cartridge housing is illustrated. Figures 146 to 211 Examples of reusable drive member mechanism modules and cartridges are also illustrated. Figures 137 to 145 Examples and Figures 146 to 211 One difference between the embodiments is that Figures 137 to 145 The size of the electric motor and the size of the gear attached to the motor shaft are greater than Figures 137 to 145 Where parts of the two embodiments are identical and function in the same manner, the same reference numerals will be used in each embodiment.

[0333] Figures 137 to 145The device 326 shown in the figure includes a reusable module 328 and a box 330. A needle assembly 332 can be fixed to the threaded distal end of a retaining member for a drug container 334. The module 328 includes a housing 336 in which an electric motor 338 is mounted. A gear 340 is coupled to and driven by the output shaft of the motor 338. A portion of the gear 340 protrudes outwardly from the housing 336 so that it can engage a gear member 342 in the box 330 when the box 330 is attached to the module 328.

[0334] The cassette 330 includes a housing 344 that defines a protrusion 346 having a T-shaped cross-section. The module housing 336 defines a corresponding T-shaped slot 348 that receives the protrusion 346. The cassette 330 also defines a second T-shaped protrusion 350 that is received by a second T-shaped slot 352 on the housing 336. When the T-shaped protrusion slides into the T-shaped slot, a spring-biased, pivoting latch member 354 on the module 328 engages a protruding lip on the cassette to prevent the cassette from sliding out of engagement. Press the button 356 to disengage the latch member 354.

[0335] Device 360 Figures 146 to 211 , and includes a reusable module 362 and a cartridge 330. The cartridge 330 is removably secured to the module 362 in the same manner as it is secured to the module 328. The module 362 has a more slender electric motor 364 and a smaller output gear 367 coupled to the motor shaft than the module 328, but otherwise has the same construction.

[0336] Fig.164 An exploded view of a box 330 is provided. The box 330 includes a base member 366 and a retaining member 368, which together define a cartridge housing. A drive belt 370 is disposed within the cartridge housing, and a thrust member 372, a ring 374, and a collar 376 control the axial extension of the drive belt 370. A support member 378 is fixed to the distal end of the drive belt 370 and engages a piston 380 within the drug container 334. The belt 370 extends without rotating, and the support member 378 is directly fixed to the belt 370. A conventional 3 ml drug container 334 is retained within the retaining member 368. The retaining member 368 has a bayonet engagement for attaching the member 368 to the box, although other suitable means such as permanent adhesives may be used alternatively.

[0337] Figures 165 to 170366. The base 366 houses the proximal components of the cartridge and includes a window 382 that allows the gear member 367 to engage with the gear 342 formed on the thrust member 372. The base 366 also defines a T-shaped protrusion 346 and a pair of smaller protrusions 384, 386. When the cartridge 330 is engaged with the reusable module, the protrusion 384 is engaged by the latch 354, and the protrusion 386 prevents the latch 354 from accidentally disengaging externally.

[0338] Figures 171 to 176 366. The cassette collar 376 is shown in FIG. The collar 376 defines a central cylindrical opening 388. A plurality of axially extending ribs 390 are disposed within the central opening 388. As discussed further below, the ribs 390 engage axially extending grooves 371 in the drive belt 370 to prevent rotation of the extended portion of the drive belt 370. The collar 376 has a first section 392 having a non-circular cross-section that fits within the base member 366 and thereby prevents the collar 376 from rotating relative to the base 366. The ribs 390 thereby prevent the extended portion of the drive belt 370 from rotating relative to the base 366. A second section 394 is disposed distally of the end of the base 366 and receives the bayonet protrusions of the retainer 368 to thereby attach the retainer 368 to the cassette 330. The section 394 has a central opening that is cylindrical in shape with two protrusions 395 that fit between the bayonet fittings of the retainer 368. The collar 376 also includes a cylindrical protrusion 396 that extends proximally and defines a portion of the central bore 388. The cylindrical section 396 also defines an annular recess 397 on its outer surface.

[0339] Figures 177 to 181 376. The ring 374 surrounds the cylindrical section 396 and properly positions the collar 376 relative to the thrust member 372. The ring 374 also serves as a bearing between the rotatable thrust member 372 and the rotationally fixed collar 376. The annular protrusion 373 on the ring 374 fits within the annular recess 397 on the protrusion 396, and the threaded section 375 on the ring 374 secures the ring 374 to the thrust member 372. Thus, the ring 374 prevents the collar 376 from axially separating from the thrust member 372, while still permitting rotation of the thrust member 372 and the attached ring 374 relative to the collar 376.

[0340] Figures 182 to 186 370. The distal support member 378 is shown in FIG. The member 378 includes a distal support flange 398 that engages the piston 380 and a mounting rod 400 that is disposed radially inward of the distal-most portion of the drive band 370. The mounting posts 402 on the rod 400 engage with holes on the drive band 370 to mount the support member 378 to the drive band 370.

[0341] Figures 187 to 192372 is shown in FIG. 372. The thrust member 372 has a gear 342 formed on its outer periphery. In another embodiment, the gear member may be fixedly coupled to the thrust member. The gear 342 engages the gear 367, and when the motor 364 is energized and the gear 367 is rotated, the thrust member 372 rotates. The thrust member 372 has a generally cylindrical shape and rotates within and relative to the base 366. The proximal end of the thrust member 372 forms a cylindrical skirt 404, which serves as a storage bobbin for the retracted portion of the drive belt 370. The threads 406 at the distal end of the thrust member 372 engage the threads 375 on the ring 374 to secure the ring 374 to the thrust member 372. As discussed above, this also axially secures the collar 376 to the thrust member 372 while still permitting rotation of the thrust member 372 and the ring 374 relative to the collar 376.

[0342] The inner partition 408 extends inwardly and defines a central opening 410 in the thrust member 372. The partition 408 also defines a pair of generally three-dimensional helical threads 412 that act as cam ramps. The threads 412 engage the grooves 369 in the drive belt 370, which extend three-dimensionally helically on the extended portion of the drive belt 370. When the box 330 is initially assembled, a portion of the drive belt 370 is placed in an extended configuration and the threads 412 engage the grooves 369. When the thrust member 372 is subsequently rotated, the threads 412 will force the belt 470 from the retracted configuration to the extended configuration, thereby extending the axial length of the extended configuration, or, depending on the direction of rotation, force the belt from the extended configuration to the retracted configuration, thereby reducing the axial length of the extended portion of the drive belt. If the module 328 is designed to work only with the disposable cartridge 330, it would not be necessary to retract the drive belt 370 after emptying the contents of the container 334, and the module 328 could be configured so that the motor 364 would only rotate in one direction when powered, where that direction corresponds to the axial extension of the drive belt 370. It should be noted that as the threads 412 engage the three-dimensional helical grooves 369 and cause the drive belt 370 to move axially, the ribs 390 located on the collar 376 will engage the axially extending grooves 371 on the drive belt 370 and prevent rotation of the belt 370. As the belt moves into the collar 372, the adjacent edges of the belt 370 will also become engaged with each other.

[0343] Figures 193 to 198368 is shown in the figure. The holding member 368 defines a T-shaped protrusion 350 for engaging a reusable module. The holding member 368 also includes a pair of bayonet fittings 414, which are inserted into the holes defined by the sections 394 of the collar 376 and fit tightly between the protrusions 395, so that the holding member 368 is mounted to the box 330. Alternative attachment means such as permanent adhesives can be used to attach the holding member 368 to the box 330. Before the holding member 368 is mounted to the box 330, the drug container 334 is placed in the retainer 368. The threaded distal end 416 on the holding member 368 is used to attach the needle assembly 332. When the needle assembly 332 is attached to the threaded distal end 416, the needle of the assembly 332 will pierce the septum on the drug container 334, thereby dispensing the drug through the needle. The cutouts in member 368 form windows 418 that allow a user to view medication container 334, thereby determining the amount of medication remaining in the container by visual inspection.

[0344] Figures 199 to 211 The drive belt 370 is shown in FIG. Figures 199 to 202 , the drive belt 370 is shown in a configuration in which it will be received within the box 330. In this arrangement, the extended portion 420 of the belt 370 defines a three-dimensional spiral, while the retracted portion 422 of the belt 370 defines a two-dimensional spiral. Fig.199 and Fig.201 370, the distal section of the band 370 defines a pair of holes 401 that receive posts 402 to thereby mount the support member 378 to the band 370. The outer surface of the band 370 includes a plurality of regularly spaced protrusions 424 that define grooves 369, 371 therebetween. It should be noted that the protrusions 424 and grooves 369, 371 will face outward on the retracted portion 422 of the band 370, just as they do on the extended portion 420, however, for reasons of graphic simplicity and clarity, Figure 199 to Figure 201 The protrusions 424 or the grooves 369 , 371 are not shown.

[0345] Figure 203 to Figure 207 The various features of the drive belt 370 are best shown in the Figures, which show the drive belt 370 unrolled and laid on a flat surface. Fig.203 and detailed view Fig.206 The outwardly facing surface of the drive belt 370 is shown, and Fig.205 and detailed view Fig.207 The inwardly facing surface of the drive belt 370 is shown. Fig.204 The edge of the strip 370 is shown.

[0346] like Fig.206As best shown, the protrusions 424 on the radially outward facing surface of the band 370 define two sets of parallel grooves 369, 371 between the protrusions 424. The grooves 369 extend in a three-dimensional spiral shape on the extended portion 420 of the band 370. The grooves 369 are engaged by the threads 412 on the thrust member 372 to form the drive band 370 into a three-dimensional spiral shape. The engagement of the threads 412 with the grooves 369 also allows for the transfer of axially directed forces between the band 370 and the thrust member 372. The grooves 371 extend in an axial direction on the extended portion 420 of the band 370 and, as explained above, engage the ribs 390 on the collar 376 to prevent rotation of the extended portion 420.

[0347] like Fig.207 As best shown, one of the edges of the band 370 (shown as the distal edge 426) defines a plurality of protrusions 432, while the other edge (shown as the proximal edge 428) defines a corresponding plurality of openings 430. Fig.207 424, the projection 432 and the projection 424 overlap along the distal edge 426. When the distal edge 426 and the proximal edge 428 of the band 370 are engaged, the proximal edge 428 will be positioned radially inward of the distal edge 426. When the distal edge 426 moves radially inward to engage the proximal edge 428, the opening 430 and projection 432 will engage to interlock the two edges, and the overlapping projection 424 will prevent the projection 432 from being pushed completely through the opening 430. The engagement of the projection 432 and the opening 430 provides shear resistance along the edges, and the shape of the projection 432 and the opening 430 (where the projection 432 has an enlarged head on a narrow neck) also resists axial separation of the two interlocked edges.

[0348] When drive belts 370 are used, only a single belt 370 will be employed per cassette 330, and the distal and proximal edges of the individual belts will interlock together in the extended portion of the belt. Figures 208 to 211 In the embodiment of the present invention, the two belts 370 are shown as being laid flat with their distal and proximal edges interlocked to provide a better understanding and graphic clarity of the interlocking of the two edges. In use, the two separate drive belts 370 will not be interlocked. Figures 208 to 211 ) (with the possible exception of doing so to form a single larger band).

[0349] Figures 212 to 216 Several additional embodiments are illustrated that use various types of controls to enhance control over and precision of the individual doses delivered by the device.

[0350] Fig.212 An embodiment is schematically illustrated that uses an encoder to enhance the Fig.42The drive belt 440 is a device that is used to control the amount of dose delivered by the device (e.g., the amount of the dose delivered by the device). In the illustrated embodiment, the rotating drive belt 440 includes a set of gear teeth 442 along its proximal edge. The electric motor 444 drives the gear 446, which in turn engages the gear teeth 442 and thereby drives the rotation of the drive belt 440. The drive belt 440 also includes a series of encoder targets 452, such as dark rectangles, which can be distinguished from the drive belt 440 by the optical sensor 450. The optical sensor 450 generates a signal received by the processor 448. By counting the number of encoder targets passed by the sensor 450, the processor 448 can determine the drive belt parameters (e.g., angular position, length or extension position, speed of extension and / or retraction, stop conditions), such as the length of the drive belt 440 that has been axially extended. The processor 448 uses this information to control the operation of the motor 444, and thereby also controls the amount of the dose delivered by the device.

[0351] Fig.213 and Fig.214 An apparatus using mechanical control to enhance control over the amount of a dose and its accuracy is schematically illustrated. Figure 213 to Figure 214 The embodiment includes a rotating drive belt 454 driven by a pre-tensioned spring 458. The spring 458 is provided with sufficient pre-tension during manufacture to rotate the drive belt 454 through its full extension. The drive belt 454 also includes a series of protrusions 456 protruding radially outward from the belt 454. The distance between each of the protrusions 456 corresponds to the amount of a predetermined dose of the drug, such as a single dose or a whole fraction thereof.

[0352] The actuator 460 is mounted on the housing 462 and includes a cam surface 464. When the actuator 460 is pressed radially inward, the cam surface 464 interacts with a control member 466. The control member 466 is disposed adjacent to an extension of the drive belt 454 and is biased to the position by a spring (not shown) or other biasing member. Fig.213 and Fig.214 In the position shown in . In this position, it blocks the passage of the protrusion 456. The control member 466 also includes a tooth defining a cam surface 468 that can engage with the cam surface 464 on the actuator 460.

[0353] When the actuator 460 is depressed, the cam surfaces 464 and 468 interact to bias the control member 466 upward, whereby the opening 470 is aligned with the protrusion 456, which engages the side of the control member 466. This allows the protrusion 456 to pass through the opening 470 and extend the drive belt 454 under the influence of the preload spring 458. The actuator 460 also includes a spring (not shown) that biases the actuator 460 out of engagement with the control member 466. Therefore, when the actuator 460 is depressed and then released, it will move the control member 466 into a position where the protrusion 456 can pass through the opening 470, and then return the control member 466 to a position where it blocks the passage of the protrusion 456. This allows the user to easily dispense a predetermined dose amount by depressing and releasing the actuator 460.

[0354] Fig.215 The device that utilizes image sensor 476 to read code 474 on rotating drive belt 472 is illustrated. Code 474 is located on drive belt 472 at predetermined intervals and is read by image sensor 476 to facilitate control of each dose delivery. The signal generated by image sensor 476 is communicated to processor 478 and can be stored in digital memory. Processor 478 controls electric motor or other suitable mechanism to rotate drive belt 472 based on the signal generated by image sensor 476. Code 474 can take various forms, for example, they can be QR code, bar code, encoder bar code. Code 474 can also take the form of different colors, whereby a specific color change corresponds to a predetermined distance along belt 472. Code 474 can be formed by screen printing graphics on drive belt, and can also include other information that can be read by image sensor 476, such as the type of medicament, the original amount of medicament and other forms of information.

[0355] for Fig.212 and Fig.215 For example, the sensor can be part of the cartridge. Alternatively, it can be part of the reusable module, wherein cooperating windows on the cartridge and the reusable module allow the sensor to observe the drive belt. Fig.216 An apparatus having an alternative configuration is illustrated that facilitates use of the sensor on a reusable module and can be used in other ways with Fig.212 and Fig.215 The control system of the embodiment is similar to the control system.

[0356] exist Fig.216 In the embodiment of the present invention, the box 480 contains a rotatable drive belt 482 having a code 484 located on the inwardly facing surface of the drive belt 482. The reusable module 486 includes Figures 121 to 126 , Figures 127 to 132 , Fig.135 and Fig.136 A proximal foot 492 is similar to the embodiment of FIG. A rod 490 extends from the proximal foot 492 and has a sensor 488 mounted on its free end to read the code 484 on the inwardly facing surface of the drive belt 482.

[0357] Any of the devices described herein may include a controller (also referred to herein as an electronic module) and / or an electronic display. The display may include any one or any combination of two or more light emitting diodes, electronic ink technology, or liquid crystal technology. The display is connected to and controlled by an electronic controller or computing component mounted in a housing by a circuit. The controller includes conventional components, such as, for example, a processor, a power supply, a memory, etc. The controller is programmed to implement the electronic features of any of the devices described herein, including causing the display of the set dose. The set dose displayed in the display may be determined by the interaction of any one or more of the dose setting and / or dose delivery drive mechanism and the sensing system, which is connected to the controller by a circuit or communicates wirelessly with the controller. The controller includes control logic that operates to perform the operations described herein, including detecting the dose delivered by the drug delivery device based on the detected rotation or linear extension of the drive belt member relative to the actuator. The controller is operable to determine the dose setting by (one or more) drive belt parameters, such as positions based on the rotational and / or linear positions of the corresponding components, which are determined by correlating the electrical characteristics (such as voltage or resistance) and the number of revolutions from the corresponding sensors to the exact and / or absolute positions from the database, the lookup table, or other data stored in the memory. The controller is operable to determine the dose delivery by determining the drive belt position based on the rotational and / or linear positions of the corresponding components, which are determined by correlating the electrical characteristics (such as voltage or resistance) and the number of revolutions from the corresponding sensor belt to the exact and / or absolute positions from the database, the lookup table, or other data stored in the memory. The controller operates to store the detected dose in a local memory (e.g., an internal flash memory or an onboard EEPROM). The controller further operates to wirelessly transmit a signal representing the detected dose to a paired remote electronic device, such as a user's smartphone, via Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocols. Illustratively, the BLE control logic and the controller are integrated on the same circuit.

[0358] While this invention has been described as having an exemplary design, the present disclosure can be further modified within the spirit and scope of the present disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles.

[0359] Various aspects are described in this disclosure, including but not limited to the following: 1. A drug delivery device for use with a container, the container having a container body containing a drug and defining an outlet, the container including a piston disposed within the container body, wherein advancement of the piston within the container body discharges the drug through the outlet, the delivery device comprising: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container, wherein the drive assembly comprises: a drive belt having a distal edge segment and a proximal edge segment, the drive belt being incrementally movable about a drive axis between a retracted configuration and an extended configuration, wherein in the retracted configuration a retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration an extended portion of the drive belt defines a three-dimensional spiral; and a thrust member engaged with the drive belt and rotatable relative to the drive belt and the housing, wherein in response to rotation of the thrust member, the drive belt is movable between the retracted configuration and the extended configuration without any rotation relative to the housing or the container.

[0360] 2. A device according to aspect 1, wherein the thrust member is axially stationary.

[0361] 3. A device according to any one of aspects 1 to 2, wherein the thrust member includes a three-dimensional helical thread capable of engaging with the drive belt, and the device also includes a rotation restraining member, which is rotationally fixed relative to the shell and engages with the drive belt to prevent relative rotation between the extended portion of the drive belt and the rotation restraining member.

[0362] 4. The device according to aspect 3, wherein one of the rotation restraining member and the extended portion of the drive belt defines an axially extending key, and the other of the rotation restraining member and the extended portion of the drive belt defines an axially extending keyway to accommodate the key.

[0363] 5. The device according to any one of aspects 3 to 4, wherein the rotation restricting member is provided radially outside the drive belt at an engagement position where the rotation restricting member engages with the drive belt to prevent rotation.

[0364] 6. The device according to any one of aspects 3 to 4, wherein the rotation restricting member is provided radially inwardly of the drive belt at an engagement position where the rotation restricting member engages with the drive belt to prevent rotation.

[0365] 7. The device according to any one of aspects 3 to 6, wherein the three-dimensional helical thread is arranged radially outside the drive belt at an engagement position where the three-dimensional helical thread engages with the drive belt.

[0366] 8. The device according to any one of aspects 3 to 7, wherein the thrust member is axially captured by the rotation constraining member.

[0367] 9. The device according to any one of aspects 3 to 8, wherein the three-dimensional helical thread is arranged radially inside the drive belt at an engagement position where the three-dimensional helical thread engages with the drive belt.

[0368] 10. A device according to any one of Aspects 1 to 9, wherein, in response to the rotation of the thrust member, the thrust member is capable of moving axially in the proximal direction and the distal end of the drive belt remains axially stationary, and wherein, in order to advance the piston within the container body, the thrust member and the extended portion of the drive belt move axially in the distal direction.

[0369] 11. A device according to aspect 10, wherein the thrust member includes a three-dimensional helical thread capable of engaging with the drive belt, and the three-dimensional helical thread is arranged radially outside the drive belt at an engagement position where the three-dimensional helical thread engages with the drive belt, and the device also includes a rotation restraining member, which is rotationally fixed relative to the shell and engaged with the drive belt to prevent relative rotation between the extended portion of the drive belt and the rotation restraining member.

[0370] 12. A device according to aspect 10, wherein the thrust member includes a three-dimensional helical thread capable of engaging with the drive belt, and the three-dimensional helical thread is arranged radially inside the drive belt at an engagement position where the three-dimensional helical thread engages with the drive belt, and the device also includes a rotation restraining member, which is rotationally fixed relative to the shell and engaged with the drive belt to prevent relative rotation between the extended portion of the drive belt and the rotation restraining member.

[0371] 13. A device according to any one of Aspects 10 to 12, further comprising a drive spring which is tensioned when the thrust member rotates to extend the drive belt, wherein, in response to releasing the tension of the drive spring, the drive spring is configured to cause the thrust member and the extended portion of the drive belt to move axially forward.

[0372] 14. A drug delivery device for use with a container, the container having a container body containing a drug and defining an outlet, the container including a piston disposed within the container body, wherein advancement of the piston within the container body discharges the drug through the outlet, the delivery device comprising: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container, wherein the drive assembly comprises: a drive belt having a distal edge segment and a proximal edge segment, the drive belt having a retracted configuration and an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral, the drive belt being capable of incrementally moving about a drive axis from the retracted configuration to the extended configuration, wherein the drive belt rotates during movement from the retracted configuration to the extended configuration, and wherein the drive assembly and the drive belt are in a coaxial relationship.

[0373] 15. The device according to aspect 14 further includes: a drive member, which is arranged radially inside the drive belt, and the drive member is configured to drive and rotate the drive belt; and a ring, which includes a three-dimensional helical thread, which is engaged radially outside the drive belt to control the movement of the drive belt between the retracted configuration and the extended configuration.

[0374] 16. The device according to aspect 14 further includes: a drive member, which is arranged radially inside the drive belt, and the drive member is configured to drive and rotate the drive belt; and a three-dimensional helical thread, which engages with the drive belt to control the movement of the drive belt between the retracted configuration and the extended configuration.

[0375] 17. The device of aspect 14, further comprising a drive member disposed radially outward of the drive belt, the drive member being configured to drivingly rotate the drive belt.

[0376] 18. The device according to aspect 17, wherein the drive member is a ring gear, multiple ring gears, a belt, multiple planetary gears, a worm gear or a key drive.

[0377] 19. Apparatus according to aspect 18, wherein the drive belt defines a plurality of slots engageable by the drive member.

[0378] 20. The device of aspect 18, wherein the drive belt defines a plurality of ribs engageable by the drive member.

[0379] 21. A drug delivery device for use with a container, the container having a container body containing a drug and defining an outlet, the container including a piston disposed in the container body, wherein advancement of the piston in the container body discharges the drug through the outlet, the delivery device comprising: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston in the container, wherein the drive assembly comprises: a drive belt having a distal edge segment and a proximal edge segment, the drive belt having a retracted configuration and an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines two dimensional spiral, and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral, the drive belt is capable of incrementally moving about a drive axis from the retracted configuration to the extended configuration, wherein, in response to the movement of the drive belt from the retracted configuration to the extended configuration, the drive belt defines a transition portion arranged between the retracted portion and the extended portion, wherein along the transition portion, the distal edge segment and the proximal edge segment of the drive belt are not engaged together; and a drive member, the drive member being engaged with the drive belt to drivingly rotate the drive belt, the drive member being engaged with the retracted portion or the transition portion of the drive belt.

[0380] 22. The device according to aspect 21, wherein the drive member is a reciprocating drive member.

[0381] 23. The device of aspect 22, wherein the reciprocating drive member engages a radially inwardly facing surface of the drive belt.

[0382] 24. A device according to aspect 22, wherein the reciprocating drive member is capable of moving in a first direction and an opposite second direction, and the reciprocating drive member includes at least one flexible ratchet member capable of engaging with the drive belt to allow relative movement between the drive member and the drive belt in the first direction and prohibit relative movement between the drive member and the drive belt in the second direction.

[0383] 25. The device of aspect 24, further comprising at least one stationary ratchet member fixed to the housing, the stationary ratchet member comprising a plurality of ratchet members engaging a radially outwardly facing surface of the drive belt.

[0384] 26. The device of aspect 21, wherein the drive member comprises a worm gear engageable with the drive belt.

[0385] 27. The device of aspect 21, wherein a storage bobbin for the retracted portion of the drive belt comprises the drive member.

[0386] 28. An apparatus according to any one of aspects 1 to 27, wherein the drive belt includes a plurality of sensor targets arranged at predetermined intervals along the drive belt, and the apparatus further includes a sensor suitable for sensing the sensor targets, wherein the sensed movement of the sensor targets passing through the sensor during operation of the drive belt toward the extended configuration is used to control the movement of the drive belt.

[0387] 29. Apparatus according to aspect 28, wherein the sensor target is disposed on the radially outwardly facing surface of the extended portion of the drive belt.

[0388] 30. The apparatus of aspect 28, wherein the sensor target is disposed on the radially inwardly facing surface of the extended portion of the drive belt.

[0389] 31. A device according to any one of aspects 1 to 27, wherein the drive belt includes a plurality of protrusions arranged at predetermined intervals along the drive belt, and the device also includes a control member positioned adjacent to the extension portion, the control member being capable of selectively moving between a position allowing the protrusion to rotate through the control member and another position wherein the control member blocks the protrusion from passing and thereby stops the rotation and extension of the drive belt.

[0390] 32. A drug delivery device for use with a container, the container having a container body containing a drug and defining an outlet, the container including a piston disposed within the container body, wherein advancement of the piston within the container body discharges the drug through the outlet, the delivery device comprising: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container, wherein the drive assembly comprises: a drive belt having a distal edge section and a proximal edge section, the drive belt having a retracted configuration and an extended configuration, wherein in The drive belt is capable of being incrementally moved from the retracted configuration to the extended configuration, wherein the movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis; and a drive mechanism operably coupled to the drive belt, the drive mechanism defining a secondary axis parallel to the drive axis, the drive mechanism generating a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0391] 33. A device according to aspect 32, wherein the drive mechanism includes a spring aligned with the secondary axis, wherein, in response to setting a dose, the spring is in a tensioned configuration, and wherein, in response to releasing the spring from the tensioned configuration, the spring is operable to generate a force that can be transmitted to move the drive belt from the retracted configuration to the extended configuration.

[0392] 34. A device according to aspect 32, wherein the drive mechanism includes a plunger arranged along the secondary axis, wherein linear translation of the plunger is configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0393] 35. A device according to aspect 32, wherein the drive mechanism includes an electric motor that is drivingly connected to an element arranged along the secondary axis, and the electric motor is configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0394] 36. Apparatus according to aspect 35, wherein the element arranged along the secondary axis is a drive shaft of the electric motor.

[0395] 37. The device of any one of aspects 32 to 36, wherein the drive belt and the drive mechanism are disposed within the housing and the container is removably attachable to the housing.

[0396] 38. A device according to any one of aspects 32 to 37, wherein the drive mechanism is arranged in the shell, and the device also includes a cartridge housing, wherein the drive belt is arranged in the cartridge housing, and the container is mounted on the cartridge housing, and the cartridge housing can be detachably fixed to the shell.

[0397] 39. A device according to aspect 38, wherein the drive mechanism includes a spring aligned with the secondary axis, wherein, in response to setting a dose, the spring is in a tensioned state, wherein the spring is configured to generate a force when the tension is released, and the force is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0398] 40. A device according to aspect 38, wherein the drive mechanism includes an electric motor that is drivingly connected to an element arranged along the secondary axis, and the electric motor is configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0399] 41. The device of aspect 40, further comprising a power source disposed within the cartridge housing, the power source being operably coupled to the electric motor when the cartridge housing is secured to the housing to thereby power the electric motor.

[0400] 42. A device according to any one of aspects 32 to 41, wherein the shell is suitable for accommodating one of a plurality of cartridges, each of the cartridges comprising a cartridge housing having a drive belt arranged inside the cartridge housing and a container mounted on the cartridge housing, and each of the cartridges can be interchangeably and detachably fixed to the shell.

[0401] 43. A device according to aspect 38, wherein the electronic module is disposed on the shell, and the cartridge includes the cartridge shell and the drive belt, the cartridge also including a digital memory device, when the cartridge is connected to the shell, the electronic module communicates with the digital memory device of the cartridge, wherein after completing the injection procedure, the electronic module is configured to record data related to the injection procedure on the digital memory device.

[0402] 44. The device of aspect 43, wherein the data recorded on the digital memory device includes data relating to an amount of medication remaining in the container.

[0403] 45. The device of any one of aspects 1 to 44, wherein the cartridge is disposable.

[0404] 46. ​​A device according to aspect 42, wherein the drive mechanism includes an electric motor that is drivingly connected to an element arranged along the secondary axis, and the electric motor is configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

[0405] 47. A device according to aspect 46, wherein an electronic module is disposed on the shell and each of the plurality of cartridges further comprises a digital memory device, wherein the electronic module communicates with the digital memory device of the cartridge when the cartridge is connected to the shell, wherein after completion of an injection procedure, the electronic module is configured to record data related to the injection procedure on the digital memory device.

[0406] 48. An apparatus according to aspect 47, wherein the drive belt includes a plurality of sensor targets arranged at predetermined intervals along the drive belt, and the apparatus further includes a sensor suitable for sensing the sensor targets, whereby movement of the sensor targets past the sensor when the drive belt is extended is used to control movement of the drive belt to the extended configuration.

[0407] 49. The apparatus of aspect 48, wherein the sensor is supported by the housing and the sensor target is disposed on the radially inwardly facing surface of the extended portion of the drive belt.

[0408] 50. A drug delivery device for use with a container, the container having a container body containing a drug and defining an outlet, the container including a piston disposed in the container body, wherein advancement of the piston in the container body discharges the drug through the outlet, the delivery device comprising: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston in the container, wherein the drive assembly comprises: a drive belt having a distal edge section and a proximal edge section, the drive belt having a retracted configuration and an extended configuration, wherein in the retracted configuration the drive belt is The retracted portion of the belt defines a two-dimensional spiral, and the extended portion of the drive belt in the extended configuration defines a three-dimensional spiral, the drive belt being capable of incrementally moving from the retracted configuration to the extended configuration to advance the piston within the container body, wherein movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis, wherein one of the distal edge segment and the proximal edge segment defines a plurality of edge protrusions, and the other of the distal edge segment and the proximal edge segment defines a plurality of openings, the openings being configured to receive corresponding edge protrusions in an interlocking manner when the drive belt is in the extended configuration.

[0409] 51. The apparatus of aspect 50, wherein the radially outwardly facing surface of the drive belt comprises a plurality of regularly spaced surface protrusions, each of the surface protrusions being defined by intersecting first and second grooves.

[0410] 52. A device according to aspect 51, wherein, when the drive belt is in the extended configuration, a portion of the surface protrusion overlaps with the other of the distal edge segment and the proximal edge segment in a manner extending over one of the distal edge segment and the proximal edge segment.

[0411] 53. A drug delivery device, comprising: a drive module, which includes a module housing, a motor disposed in the module housing, and a drive gear operably connected to the shaft of the motor; a box, which includes a box housing, and the box housing is configured to be connected to the module housing; the box includes a container body that contains the drug and defines an outlet, and the box includes a piston disposed in the container body; a drive belt, which can be incrementally extended axially to advance the piston in the container body, thereby expelling the drug through the outlet; and a thrust member, which includes a driven gear element operably connected to the drive gear, the thrust member engaging with the drive belt and capable of moving to extend or retract the drive belt.

[0412] 54. The device of aspect 53, wherein the cartridge housing houses the drive belt and the thrust member.

[0413] 55. An apparatus according to any one of Aspects 53 to 54, wherein the box housing includes at least one power source to power the electric motor of the drive module, an electronic module disposed within the module housing, and a memory containing data regarding the type of drug, the remaining amount of the drug, a manufacturing date and / or a serial number, wherein the memory communicates with the electronic module of the module housing when the box housing is attached to the module housing.

[0414] 56. The device of any one of aspects 53 to 55, wherein the cartridge housing comprises attachment features for securely coupling the cartridge housing to the module housing.

[0415] 57. The device of aspect 56, wherein the attachment feature is configured to allow the cartridge housing to be selectively detached from the module housing.

[0416] 58. The device of aspect 57, wherein the module housing includes a releasable latch to allow the cartridge housing to be removed from the module housing.

[0417] 59. An apparatus according to any one of aspects 53 to 58, wherein the box also includes a ring arranged axially from the thrust member along the box housing, the ring including one or more axial ribs received by corresponding axial grooves, and the axial grooves are defined by the drive belt.

[0418] 60. The device of aspect 59, wherein the thrust member is disposed radially outwardly of the drive band, the thrust member comprising internal threads engageable with corresponding lateral grooves defined by the drive band.

[0419] 61. An apparatus according to any one of Aspects 53 to 60, further comprising an electronic module in communication with an encoder sensor, wherein the encoder sensor is configured to detect a coding pattern defined by the drive belt to determine at least one of the type of drug, the original amount of drug, the angular position of the drive belt, the axial position of the drive belt, the extension and / or retraction speed of the drive belt, and the stopping condition of the drive belt, or to control the movement of the drive belt.

Claims

1. A drug delivery device, comprising: A housing including a drive module; and A drug cartridge for removably attaching to the drive module, comprising: a cartridge housing configured to be attached to and detached from the drive module; a container body for containing a drug and defining an outlet; a piston disposed within the container body; a drive belt disposed within the container body to advance the piston, wherein the drive belt includes a distal edge segment and a proximal edge segment, the drive belt being incrementally movable about a drive axis from a retracted configuration to an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral; a drive member engaged with an interior of the drive belt and operably coupled to the drive module; and a rotatable bearing assembly having a first member fixed to the drive belt and a second member rotatable relative to the first member, the second member configured to directly bear against the piston, wherein in response to rotation of the drive member, the drive belt rotates and extends axially, and the piston advances within the container body to expel the drug through the outlet.

2. The device according to claim 1, further comprising: A collar includes a three-dimensional helical thread engaged radially outwardly of the drive band to control movement of the drive band between the retracted configuration and the extended configuration.

3. The device according to claim 1, further comprising: A three-dimensional helical thread engages the drive band to control movement of the drive band between the retracted configuration and the extended configuration.

4. The device according to claim 1, further comprising: The drive module includes an electric motor configured to generate a force that is transmitted to the drive belt via the drive member to move the drive belt from the retracted configuration to the extended configuration.

5. The device according to claim 4, wherein: The electric motor is coupled to a drive element having cooperating surfaces for engaging and rotationally driving the drive member.

6. The device according to claim 5, wherein: The drive belt defines a plurality of slots engageable by the drive member.

7. The device according to claim 5, wherein: The drive belt defines a plurality of ribs engageable by the drive member.

8. A drug delivery device for use with a container having a container body containing a drug and defining an outlet, the container including a piston disposed within the container body, wherein: The advancement of the piston within the container body discharges the drug through the outlet, and the delivery device comprises: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container, wherein the drive assembly comprises: a drive belt having a distal edge segment and a proximal edge segment, the drive belt having a retracted configuration and an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines a two-dimensional spiral and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral, the drive belt being incrementally movable about a drive axis from the retracted configuration to the extended configuration, wherein in response to movement of the drive belt from the retracted configuration to the extended configuration the drive belt defines a transition portion disposed between the retracted portion and the extended portion, wherein along the transition portion the distal edge segment and the proximal edge segment of the drive belt are not joined together; and A drive member is engaged with the drive belt to drivingly rotate the drive belt, the drive member being engaged with the retracted portion or the transition portion of the drive belt.

9. The device according to claim 8, wherein: The drive member is a reciprocating drive member.

10. The device according to claim 9, wherein: The reciprocating drive member engages a radially inwardly facing surface of the drive belt.

11. The device according to claim 9, wherein: The reciprocating drive member is movable in a first direction and an opposite second direction, the reciprocating drive member including at least one flexible ratchet member engageable with the drive belt to allow relative movement between the drive member and the drive belt in the first direction and inhibit relative movement between the drive member and the drive belt in the second direction.

12. The device of claim 11 further comprising at least one stationary ratchet member secured to the housing, the stationary ratchet member comprising a plurality of ratchet members engaging a radially outwardly facing surface of the drive band.

13. The device according to claim 8, wherein: The drive member includes a worm gear engageable with the drive belt.

14. The device according to claim 8, wherein: A storage bobbin for the retracted portion of the drive belt comprises the drive member.

15. The device according to claim 8, wherein: The drive belt comprises a plurality of sensor targets arranged at predetermined intervals along the drive belt, and the device further comprises a sensor adapted to sense the sensor targets, wherein sensed movement of the sensor targets past the sensor during operation of the drive belt towards the extended configuration is used to control the movement of the drive belt.

16. The device according to claim 15, wherein: The sensor target is disposed on the radially outwardly facing surface of the extended portion of the drive belt.

17. The device according to claim 15, wherein: The sensor target is disposed on the radially inwardly facing surface of the extended portion of the drive belt.

18. The device according to claim 8, wherein: The drive belt includes a plurality of protrusions arranged at predetermined intervals along the drive belt, and the device also includes a control member positioned adjacent to the extension portion, the control member being selectively movable between a position allowing the protrusions to rotationally pass through the control member and another position in which the control member blocks the protrusions from passing and thereby stops the rotation and extension of the drive belt.

19. A drug delivery device for use with a container having a container body containing a drug and defining an outlet, the container comprising a piston disposed within the container body, wherein: The advancement of the piston within the container body discharges the drug through the outlet, and the delivery device comprises: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container, wherein the drive assembly comprises: a drive belt having a distal edge segment and a proximal edge segment, the drive belt having a retracted configuration and an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines a two-dimensional spiral and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral, the drive belt being incrementally movable from the retracted configuration to the extended configuration, wherein movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis; and A drive mechanism is operably coupled to the drive belt, the drive mechanism defining a secondary axis parallel to the drive axis, the drive mechanism generating a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

20. The device according to claim 19, wherein The drive mechanism comprises a spring aligned with the secondary axis, wherein, in response to setting a dose, the spring is in a tensioned configuration, wherein, in response to releasing the spring from the tensioned configuration, the spring is operable to generate a force transmittable to move the drive band from the retracted configuration to the extended configuration.

21. The device according to claim 19, wherein The drive mechanism includes a plunger disposed along the secondary axis, wherein linear translation of the plunger is configured to generate a force that is transmitted to the drive band to move the drive band from the retracted configuration to the extended configuration.

22. The device according to claim 19, wherein The drive mechanism includes an electric motor drivingly coupled to an element disposed along the secondary axis, the electric motor configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

23. The device according to claim 22, wherein: The element arranged along the secondary axis is the drive shaft of the electric motor.

24. The device according to claim 19, wherein The drive belt and the drive mechanism are disposed within the housing, and the container is removably attachable to the housing.

25. The device according to claim 19, wherein The drive mechanism is arranged in the housing, the device further comprising a cartridge housing, wherein the drive belt is arranged in the cartridge housing and the container is mounted on the cartridge housing, the cartridge housing being detachably securable to the housing.

26. The device according to claim 25, wherein The drive mechanism comprises a spring aligned with the secondary axis, wherein the spring is in tension in response to setting a dose, wherein the spring is configured to generate a force upon release of tension that is transmitted to the drive band to move the drive band from the retracted configuration to the extended configuration.

27. The device according to claim 25, wherein: The drive mechanism includes an electric motor drivingly coupled to an element disposed along the secondary axis, the electric motor configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

28. The device of claim 27, further comprising a power source disposed within the cartridge housing, the power source operably coupled to the electric motor to thereby power the electric motor when the cartridge housing is secured to the housing.

29. The device according to claim 25, wherein: The housing is suitable for accommodating one of a plurality of cartridges, each of which includes a cartridge housing having a drive belt disposed within the cartridge housing and a container mounted on the cartridge housing, and each of the cartridges can be interchangeably and detachably fixed to the housing.

30. The device according to claim 25, wherein: The electronic module is arranged on the shell, and the cartridge includes the cartridge shell and the drive belt, the cartridge also includes a digital memory device, when the cartridge is connected to the shell, the electronic module communicates with the digital memory device of the cartridge, wherein, after completing the injection procedure, the electronic module is configured to record data related to the injection procedure on the digital memory device.

31. The device according to claim 30, wherein The data recorded on the digital memory device includes data relating to the amount of medication remaining in the container.

32. The device according to claim 31, wherein The cartridge is disposable.

33. The device according to claim 29, wherein: The drive mechanism includes an electric motor drivingly coupled to an element disposed along the secondary axis, the electric motor configured to generate a force that is transmitted to the drive belt to move the drive belt from the retracted configuration to the extended configuration.

34. The device according to claim 33, wherein An electronic module is disposed on the shell, and each of the multiple cartridges also includes a digital memory device. When the cartridge is connected to the shell, the electronic module communicates with the digital memory device of the cartridge, wherein, after the injection procedure is completed, the electronic module is configured to record data related to the injection procedure on the digital memory device.

35. The device according to claim 34, wherein The drive belt includes a plurality of sensor targets arranged at predetermined intervals along the drive belt, and the device also includes a sensor adapted to sense the sensor targets, whereby sensing movement of the sensor targets past the sensor as the drive belt extends is used to control movement of the drive belt to the extended configuration.

36. The device according to claim 35, wherein The sensor is supported by the housing, and the sensor target is disposed on the radially inwardly facing surface of the extended portion of the drive belt.

37. A drug delivery device for use with a container having a container body containing a drug and defining an outlet, the container including a piston disposed within the container body, wherein: The advancement of the piston within the container body discharges the drug through the outlet, and the delivery device comprises: a housing adapted to be coupled to the container; and a drive assembly coupled to the housing and adapted to advance the piston within the container, wherein the drive assembly comprises: A drive belt having a distal edge segment and a proximal edge segment, the drive belt having a retracted configuration and an extended configuration, wherein in the retracted configuration the retracted portion of the drive belt defines a two-dimensional spiral, and in the extended configuration the extended portion of the drive belt defines a three-dimensional spiral, the drive belt being incrementally movable from the retracted configuration to the extended configuration to advance the piston within the container body, wherein movement of the drive belt from the retracted configuration to the extended configuration defines a drive axis, wherein one of the distal edge segment and the proximal edge segment defines a plurality of edge protrusions, and the other of the distal edge segment and the proximal edge segment defines a plurality of openings, the openings being configured to receive corresponding edge protrusions in an interlocking manner when the drive belt is in the extended configuration.

38. The device according to claim 37, wherein The radially outward facing surface of the drive belt includes a plurality of regularly spaced surface protrusions, each of the surface protrusions being defined by intersecting first and second grooves.

39. The device according to claim 38, wherein When the drive belt is in the extended configuration, a portion of the surface protrusion overlaps one of the distal edge segment and the proximal edge segment in a manner extending over the other of the distal edge segment and the proximal edge segment.

40. A drug delivery device comprising: a drive module comprising a module housing, a motor disposed within the module housing, and a drive gear operably coupled to a shaft of the motor; a cartridge comprising a cartridge housing configured to be coupled to the module housing; The cartridge includes a container body containing a drug and defining an outlet, the cartridge including a piston disposed within the container body; a drive belt incrementally extendable axially to advance the piston within the container body to expel the medicament through the outlet; as well as A thrust member includes a driven gear element operably coupled to the drive gear, the thrust member engaging the drive belt and being movable to extend or retract the drive belt.

41. The device according to claim 40, wherein The cassette housing accommodates the drive belt and the thrust member.

42. The device according to claim 40, wherein: The box housing includes at least one power source to power the electric motor of the drive module, an electronic module arranged in the module housing, and a memory, wherein the memory contains data about the type of drug, the remaining amount of the drug, the manufacturing date and / or the serial number, wherein when the box housing is attached to the module housing, the memory communicates with the electronic module of the module housing.

43. The device according to claim 40, wherein: The cartridge housing includes attachment features for securely coupling the cartridge housing to the module housing.

44. The device according to claim 43, wherein The attachment features are configured to allow the cartridge housing to be selectively detached from the module housing.

45. The device according to claim 44, wherein The module housing includes a releasable latch to allow the cartridge housing to be removed from the module housing.

46. ​​The apparatus of claim 40, wherein: The cassette also includes a collar disposed axially from the thrust member along the cassette housing, the collar including one or more axial ribs received by corresponding axial grooves defined by the drive band.

47. The device according to claim 46, wherein The thrust member is disposed radially outwardly of the drive band, the thrust member including internal threads engageable with corresponding lateral grooves defined by the drive band.

48. The device of claim 40, further comprising an electronic module in communication with an encoder sensor configured to detect a coding pattern defined by the drive belt to determine at least one of the type of drug, the original amount of drug, the angular position of the drive belt, the axial position of the drive belt, the extension and / or retraction speed of the drive belt, and the stopping condition of the drive belt, or to control the movement of the drive belt.

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