Medical delivery device with axially expandable drive ribbon

Abstract

To provide an injection device which is easily carried by a user.SOLUTION: In a drug delivery device 303 usable with a drug container 248, advancement of a piston within the container releases a drug. The device includes a housing 287 and a drive assembly. The drive assembly includes a drive ribbon R having a distal edge portion and a proximal edge portion. The drive ribbon has a retracted configuration defining a spiral and an extended configuration defining a helix. The drive ribbon is movable from the retracted configuration to the extended configuration, such movement defining a drive axis and advancing the piston. In some embodiments, the drive ribbon may not rotate as it is advanced, while in other embodiments, the ribbon rotates. The disclosed drive assembly includes a manual drive assembly, a spring drive assembly, and a motor drive assembly.SELECTED DRAWING: Figure 115

Description

[Background technology]

[0001] The present disclosure relates to medical delivery devices, such as injection devices.

[0002] Conventional injection devices are often used to inject medication into patients. For example, Injection pens, which use disposable cartridges containing insulin, are used by diabetics to Such pens are generally made of an elongated pen that acts on a piston in the cartridge. It contains a rod that advances a piston, which in turn delivers medication through the needle to the patient.

[0003] Throughout the injection process, including when the rod reaches its limit of advance into the cartridge. Therefore, the rod must project outward from the cartridge to engage a drive mechanism in the pen. The rod is then inserted into a new cartridge filled with drug. It also needs to be fully retracted and stored within the pen so that Conventional injection pens are generally elongated and the length of the injection pen is determined by the length of the cartridge in which the medication is contained. More than twice the length of the barrel. Similarly, in the case of refillable injection devices that are not pen-type, In this case, the length of the device is generally more than twice the length of the cartridge barrel in which the drug is contained. can.

[0004] When such an injection device is used to self-administer medication at different times throughout the day, In such cases, it is desirable for the injection device to be easily carried by the user. Patients self-administer insulin using the injection device and synchronize the device with them. Traditional injection pens and similar devices are designed to be portable. Although small enough to accommodate such devices, the length of such devices often makes transporting the devices inconvenient. do. Summary of the Invention

[0005] According to an embodiment of the present disclosure, the medication delivery device includes a container for holding a medication and defining an exit port. The present invention is provided for use with a container having a container body, the container being disposed within the container body. and a piston disposed within the container body, the advancement of the piston within the container body enabling release of the drug through the outlet. The delivery device includes a housing adapted to be coupled to the container and a and a drive assembly adapted to advance the piston within the container. The drive assembly includes a drive ribbon having a distal edge portion and a proximal edge portion. , which is progressively movable about a drive axis between a stored configuration and an extended configuration. The retracted portion of the ribbon defines a spiral, and the expanded portion of the drive ribbon in the expanded configuration The thrust member engages the drive ribbon and the drive ribbon. In response to rotation of the thrust member, the drive ribbon is It can be moved between the stowed and extended configurations without any rotation relative to the housing or container. Another embodiment of the exemplary device is provided.

[0006] In another embodiment, the drug delivery device comprises a housing adapted to couple to the container. a drive assembly coupled to the housing and adapted to advance the piston within the container. The delivery device includes a drive assembly having a distal edge portion and a proximal edge portion. The drive ribbon has a retracted configuration and an extended configuration. The retracted portion of the drive ribbon defines a spiral, and the extended portion of the drive ribbon in the extended configuration The portions define a helix. The drive ribbons are progressively movable from a retracted configuration to an extended configuration. The movement of the drive ribbon from the retracted configuration to the extended configuration defines a drive axis. is operatively coupled to the drive ribbon and defines a secondary axis parallel to the drive axis. Generate a force transmitted to the drive ribbon to move the drive ribbon from the retracted configuration to the extended configuration .

[0007] In yet another embodiment, the drug delivery device includes a housing adapted to couple with the container. a drive member coupled to the housing and adapted to advance the piston within the container. and a drive assembly. The drive assembly includes a distal edge portion and a proximal edge portion. The drive ribbon has a retracted configuration and an extended configuration, the retracted configuration including a drive ribbon having a retracted portion. The retracted portion of the drive ribbon in the extended configuration defines a spiral, and the extended portion of the drive ribbon in the extended configuration defines a spiral. The extended portions define a helix. The drive ribbons are progressively moved from the retracted configuration to the extended configuration. The piston is movable to advance the piston within the container body. The motion of the moving ribbon defines a drive axis. a protrusion, the other of the distal edge portion and the proximal edge portion being in contact with the proximal edge portion when the drive ribbon is in the expanded configuration; The recess defines a plurality of openings configured to interlockingly receive corresponding edge projections.

[0008] In yet another embodiment, the medication delivery device includes a drive module and a cassette. The drive module includes a module housing, a motor disposed within the module housing, and a The cassette includes a motor and a drive gear operably coupled to the shaft of the motor. The cassette includes a cassette housing configured to couple to a module housing. a container body for holding the medicament and defining an outlet; and a piston disposed within the container body. The drive ribbon is progressively axially expandable to advance the piston within the vessel body. , and expels the medicament through the outlet. The thrust member is a drive gear operatively coupled to the drive gear. The thrust member engages the drive ribbon and causes the drive ribbon to extend or retract. It can be moved so that it can be moved around.

[0009] The above and other features of the present disclosure, and the manner in which they are achieved, are described in detail in the following embodiments of the present disclosure. The present invention will become more apparent from the following detailed description of the embodiments taken in conjunction with the accompanying drawings, in which: , will be better understood. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic perspective view of an exemplary drive ribbon that is axially expandable without rotating the drive ribbon.

[0011] [Diagram 2] FIG. 2 is a schematic perspective view of another exemplary drive ribbon that rotates as it is axially expanded.

[0012] [Diagram 3] FIG. 3 is a schematic perspective view of another drive ribbon that rotates as it is axially expanded.

[0013] [Figure 4] FIG. 4 is a partial exploded view of an exemplary drive ribbon.

[0014] [Diagram 5]FIG. 5 is a detailed view of the drive ribbon of FIG.

[0015] [Figure 6] FIG. 6 is another detailed view of the drive ribbon of FIG.

[0016] [Figure 7] FIG. 7 is an illustration of another drive ribbon with the ribbon unfolded.

[0017] [Figure 8] FIG. 8 is a detailed view of the drive ribbon of FIG.

[0018] [Figure 9] 9 is an end view of the drive ribbon of FIG.

[0019] [Figure 10] FIG. 10 is a schematic end view of an exemplary drive assembly having drive ribbons that do not rotate when expanded.

[0020] [Figure 11] FIG. 11 is another schematic diagram of the drive assembly of FIG.

[0021] [Figure 12] FIG. 12 is a schematic end view of an exemplary drive ribbon that does not rotate as it expands.

[0022] [Figure 13] 13 is a schematic side view of a drive assembly having the drive ribbon of FIG. 12. FIG.

[0023] [Figure 14] FIG. 14 is a schematic end view of another drive assembly having a non-rotating drive ribbon.

[0024] [Figure 15] FIG. 15 is a schematic side view of an exemplary drive assembly having the drive ribbon of FIG.

[0025] [Figure 16] FIG. 16 is a schematic end view of another drive assembly having a non-rotating drive ribbon.

[0026] [Figure 17] FIG. 17 is a schematic side view of the drive assembly of FIG.

[0027] [Figure 18] FIG. 18 is a schematic end view of a drive ribbon having elongated ribs.

[0028] [Figure 19] FIG. 19 is a schematic end view of a drive ribbon having separated posts.

[0029] [Figure 20] FIG. 20 is a schematic side view of an exemplary drive assembly having a non-rotating drive ribbon.

[0030] [Figure 21] FIG. 21 is a schematic side view of another drive assembly having a non-rotating drive ribbon.

[0031] [Figure 22] FIG. 22 is a schematic end view of an exemplary drive assembly including a drive ribbon that rotates as it expands axially.

[0032] [Diagram 23] FIG. 23 is a schematic end view of another drive assembly including a drive ribbon that rotates as it expands axially.

[0033] [Figure 24] 24 is a schematic side view of the drive assembly of FIG. 23. FIG.

[0034] [Diagram 25] FIG. 25 is a schematic end view of a drive assembly having an internal gear drive for rotating the drive ribbon.

[0035] [Figure 26] FIG. 26 is a schematic end view of another drive assembly having an internal gear drive for rotating the drive ribbon.

[0036] [Figure 27] FIG. 27 is a schematic end view of a drive assembly having an external gear drive for rotating the drive ribbon.

[0037] [Figure 28] FIG. 28 is a schematic end view of another drive assembly having an external gear drive for rotating the drive ribbon.

[0038] [Figure 29] 29 is a schematic side view of the drive assembly of FIG. 28. FIG.

[0039] [Diagram 30] FIG. 30 is a schematic end view of a drive assembly having an external belt drive.

[0040] [Diagram 31] FIG. 31 is a schematic end view of a drive assembly having multiple external gears for rotating the drive ribbon.

[0041] [Diagram 32] FIG. 32 is a schematic end view of another drive assembly having multiple external gears for rotating the drive ribbon.

[0042] [Diagram 33] 33 is a schematic side view of the drive assembly of FIG. 32. FIG.

[0043] [Diagram 34] FIG. 34 is a schematic end view of an external worm gear drive.

[0044] [Diagram 35]FIG. 35 is a schematic end view of another external worm gear drive.

[0045] [Diagram 36] FIG. 36 is a schematic end view of a drive ribbon having external ribs.

[0046] [Figure 37] FIG. 37 is a schematic end view of a drive ribbon having an external slot.

[0047] [Figure 38] FIG. 38 is a schematic end view of a drive assembly having a drive ribbon with an external slot and keyed drive.

[0048] [Figure 39] 39 is a schematic side view of the drive assembly of FIG. 38. FIG.

[0049] [Diagram 40] FIG. 40 is a schematic end view of another drive assembly having a drive ribbon with an external slot and keyed drive.

[0050] [Diagram 41] FIG. 41 is a schematic side view of the drive assembly of FIG.

[0051] [Diagram 42] FIG. 42 is a schematic side view of a drive assembly in which a stored portion of the drive ribbon is driven by a bobbin.

[0052] [Diagram 43] FIG. 43 is a schematic end view of a drive assembly having a reciprocating drive member.

[0053] [Diagram 44] FIG. 44 is a schematic perspective view of a drive assembly having a worm gear.

[0054] [Diagram 45]FIG. 45 is a schematic end view of a drive assembly having a reciprocating drive member having a plurality of ratchet members.

[0055] [Figure 46] FIG. 46 is a schematic diagram of an exemplary device having an in-line drive assembly.

[0056] [Figure 47] FIG. 47 is a side view of the device of FIG.

[0057] [Figure 48] FIG. 48 is an end view of the device of FIG.

[0058] [Figure 49] FIG. 49 is a schematic diagram of an exemplary device having a secondary axis.

[0059] [Figure 50] FIG. 50 is a side view of the device of FIG.

[0060] [Figure 51] FIG. 51 is an end view of the device of FIG.

[0061] [Figure 52] FIG. 52 is a schematic diagram of another device having a secondary axis.

[0062] [Diagram 53] FIG. 53 is a side view of the device of FIG.

[0063] [Figure 54] FIG. 54 is an end view of the device of FIG.

[0064] [Figure 55] FIG. 55 is a schematic diagram of an exemplary device having a secondary axis.

[0065] [Figure 56] FIG. 56 is a side view of the device of FIG.

[0066] [Figure 57] FIG. 57 is an end view of the device of FIG.

[0067] [Figure 58] FIG. 58 is an end view of the device of FIG.

[0068] [Figure 59] FIG. 59 is a schematic diagram of the drive member mechanism of the device of FIG. 55 in a dial dose setting configuration.

[0069] [Figure 60] FIG. 60 is a schematic diagram of the drive member mechanism of the device of FIG. 55 in an infusion dose delivery configuration.

[0070] [Figure 61] FIG. 61 is a schematic diagram of an exemplary device having a secondary axis.

[0071] [Figure 62] FIG. 62 is a side view of the device of FIG.

[0072] [Figure 63] FIG. 63 is an end view of the device of FIG.

[0073] [Figure 64] FIG. 64 is an end view of the device of FIG.

[0074] [Figure 65] FIG. 65 is a schematic diagram of the drive member mechanism of the device of FIG. 61 in a dial dose setting configuration.

[0075] [Figure 66] FIG. 66 is a schematic diagram of the drive member mechanism of the device of FIG. 61 in an infusion dose delivery configuration.

[0076] [Figure 67] FIG. 67 is a schematic diagram of an exemplary device having a secondary axis.

[0077] [Figure 68] FIG. 68 is a side view of the device of FIG.

[0078] [Figure 69] FIG. 69 is an end view of the device of FIG.

[0079] [Figure 70] FIG. 70 is an end view of the device of FIG.

[0080] [Figure 71] FIG. 71 is a schematic diagram of the drive member mechanism of the device of FIG. 67 in a dial dose setting configuration.

[0081] [Figure 72] FIG. 72 is a schematic diagram of the drive member mechanism of the device of FIG. 67 in an infusion dose delivery configuration.

[0082] [Figure 73] FIG. 73 is a schematic diagram of an exemplary device having a secondary axis.

[0083] [Figure 74] FIG. 74 is a side view of the device of FIG.

[0084] [Figure 75] FIG. 75 is an end view of the device of FIG.

[0085] [Figure 76] FIG. 76 is an end view of the device of FIG.

[0086] [Figure 77]FIG. 77 is a schematic diagram of the drive member mechanism of the device of FIG. 73 in a dial dose setting configuration.

[0087] [Figure 78] FIG. 78 is a schematic diagram of the drive member mechanism of the device of FIG. 73 in an infusion dose delivery configuration.

[0088] [Figure 79] FIG. 79 is a schematic diagram of an exemplary device having a secondary axis.

[0089] [Figure 80] FIG. 80 is a side view of the device of FIG.

[0090] [Figure 81] FIG. 81 is an end view of the device of FIG.

[0091] [Figure 82] FIG. 82 is an end view of the device of FIG.

[0092] [Figure 83] FIG. 83 is a schematic diagram of the drive member mechanism of the device of FIG. 79 in a dial dose setting configuration.

[0093] [Figure 84] FIG. 84 is a schematic diagram of the drive member mechanism of the device of FIG. 79 in an infusion dose delivery configuration.

[0094] [Figure 85] FIG. 85 is a schematic diagram of an exemplary device having a secondary axis.

[0095] [Figure 86] FIG. 86 is a side view of the device of FIG.

[0096] [Figure 87] FIG. 87 is an end view of the device of FIG.

[0097] [Figure 88] FIG. 88 is an end view of the device of FIG.

[0098] [Figure 89] FIG. 89 is a schematic diagram of the drive member mechanism of the device of FIG. 85 in a dial dose setting configuration.

[0099] [Figure 90] FIG. 90 is a schematic diagram of the drive member mechanism of the device of FIG. 85 in an infusion dose delivery configuration.

[0100] [Figure 91] FIG. 91 is a schematic diagram of an exemplary device having a secondary axis.

[0101] [Figure 92] FIG. 92 is a side view of the device of FIG.

[0102] [Figure 93] FIG. 93 is an end view of the device of FIG.

[0103] [Figure 94] FIG. 94 is an end view of the device of FIG.

[0104] [Figure 95] FIG. 95 is a schematic diagram of the drive member mechanism of the device of FIG.

[0105] [Figure 96] FIG. 96 is a schematic diagram of the drive member mechanism of the device of FIG.

[0106] [Figure 97] FIG. 97 is a schematic diagram of an exemplary device having a secondary axis.

[0107] [Figure 98] FIG. 98 is a side view of the device of FIG.

[0108] [Figure 99] FIG. 99 is an end view of the device of FIG.

[0109] [Figure 100] FIG. 100 is an end view of the device of FIG.

[0110] [Figure 101] FIG. 101 is a schematic diagram of the drive member mechanism of the device of FIG.

[0111] [Figure 102] FIG. 102 is a schematic diagram of the drive member mechanism of the device of FIG.

[0112] [Figure 103] FIG. 103 is a schematic diagram of a device having a separable cassette and drive module.

[0113] [Figure 104] FIG. 104 is a side view of the device of FIG.

[0114] [Figure 105] FIG. 105 is an end view of the device of FIG.

[0115] [Figure 106] FIG. 106 is an end view of the device of FIG.

[0116] [Figure 107] FIG. 107 is a side view of the cassette of FIG.

[0117] [Figure 108] 108 is a side view of the drive member mechanism module of FIG.

[0118] [Fig. 109]FIG. 109 is a schematic diagram of an exemplary device having a separable cassette and drive module.

[0119] [Figure 110] FIG. 110 is a side view of the device of FIG.

[0120] [Figure 111] FIG. 111 is an end view of the device of FIG.

[0121] [Figure 112] FIG. 112 is an end view of the device of FIG.

[0122] [Figure 113] FIG. 113 is a side view of the cassette of FIG.

[0123] [Fig. 114] 114 is a side view of the drive member mechanism module of FIG.

[0124] [Figure 115] FIG. 115 is a schematic diagram of an exemplary device having a separable cassette and drive module.

[0125] [Fig. 116] FIG. 116 is a side view of the device of FIG.

[0126] [Figure 117] FIG. 117 is an end view of the device of FIG.

[0127] [Fig. 118] FIG. 118 is an end view of the device of FIG.

[0128] [Figure 119] FIG. 119 is a side view of the cassette of FIG.

[0129] [Figure 120] 120 is a side view of the drive member mechanism module of FIG.

[0130] [Figure 121] FIG. 121 is a schematic diagram of an exemplary device having a separable cassette and drive module.

[0131] [Figure 122] FIG. 122 is a side view of the device of FIG.

[0132] [Figure 123] FIG. 123 is an end view of the device of FIG.

[0133] [Figure 124] FIG. 124 is an end view of the device of FIG.

[0134] [Fig. 125] FIG. 125 is a side view of the cassette of FIG.

[0135] [Fig. 126] 126 is a side view of the drive member mechanism module of FIG.

[0136] [Figure 127] FIG. 127 is a schematic diagram of an exemplary device having a separable cassette and drive module.

[0137] [Figure 128] FIG. 128 is a side view of the device of FIG.

[0138] [Figure 129] FIG. 129 is an end view of the device of FIG.

[0139] [Fig. 130] FIG. 130 is an end view of the device of FIG.

[0140] [Fig. 131] FIG. 131 is a side view of the cassette of FIG.

[0141] [Fig. 132] 132 is a side view of the drive member mechanism module of FIG.

[0142] [Fig. 133] FIG. 133 is a schematic diagram of an exemplary drive member mechanism module having an attached cassette and an additional cassette.

[0143] [Fig. 134] FIG. 134 is a schematic diagram of the drive member mechanism module and multiple cassettes of FIG.

[0144] [Fig. 135] FIG. 135 is a schematic diagram of an exemplary drive member mechanism module having an attached cassette and an additional cassette.

[0145] [Fig. 136] FIG. 136 is a schematic diagram of the drive member mechanism module and multiple cassettes of FIG.

[0146] [Fig. 137] FIG. 137 is a side view of an exemplary device having a cassette and a modular drive member mechanism.

[0147] [Figure 138] FIG. 138 is another side view of the device of FIG.

[0148] [Figure 139] FIG. 139 is an end view of the device of FIG.

[0149] [Fig. 140] FIG. 140 is a cross-sectional view taken along line AA in FIG.

[0150] [Fig. 141] FIG. 141 is a cross-sectional view taken along line BB in FIG.

[0151] [Fig. 142] FIG. 142 is a cross-sectional view taken along line CC in FIG.

[0152] [Fig. 143] FIG. 143 is an exploded view of the device of FIG. 137 showing the drive member mechanism and cassette separated.

[0153] [Fig. 144] FIG. 144 is an exploded view of the device of FIG. 137 showing the drive member mechanism and cassette separated.

[0154] [Fig. 145] FIG. 145 is an exploded view of the device of FIG. 137 showing the drive member mechanism and cassette separated.

[0155] [Fig. 146] FIG. 146 is a side view of an exemplary device having a cassette and a modular drive member mechanism.

[0156] [Fig. 147] FIG. 147 is another side view of the device of FIG.

[0157] [Fig. 148] FIG. 148 is an end view of the device of FIG.

[0158] [Figure 149] FIG. 149 is a cross-sectional view taken along line AA in FIG.

[0159] [Fig. 150] FIG. 150 is a cross-sectional view taken along line BB in FIG.

[0160] [Fig. 151] FIG. 151 is a cross-sectional view taken along line CC in FIG.

[0161] [Fig. 152] FIG. 152 is an exploded view of the device of FIG. 146 showing the drive member mechanism and cassette separated.

[0162] [Fig. 153] FIG. 153 is an exploded view of the device of FIG. 146 showing the drive member mechanism and cassette separated.

[0163] [Fig. 154] FIG. 154 is an exploded view of the device of FIG. 146 showing the drive member mechanism and cassette separated.

[0164] [Fig. 155] FIG. 155 is a perspective view of the cassette.

[0165] [Fig. 156] FIG. 156 is a side view of the cassette of FIG.

[0166] [Fig. 157] 157 is another side view of the cassette of FIG.

[0167] [Fig. 158] 158 is an end view of the cassette of FIG.

[0168] [Fig. 159] FIG. 159 is a cross-sectional view taken along line DD in FIG.

[0169] [Fig. 160] FIG. 160 is a cross-sectional view taken along line EE in FIG.

[0170] [Fig. 161]FIG. 161 is a cross-sectional view taken along line FF in FIG.

[0171] [Fig. 162] FIG. 162 is a cross-sectional view taken along line GG in FIG.

[0172] [Fig. 163] FIG. 163 is a cross-sectional view taken along line HH in FIG.

[0173] [Fig. 164] FIG. 164 is an exploded perspective view of the cassette.

[0174] [Fig. 165] FIG. 165 is a perspective view of the cassette base of FIG.

[0175] [Fig. 166] FIG. 166 is a perspective view of the cassette base of FIG.

[0176] [Fig. 167] FIG. 167 is an end view of the cassette base of FIG.

[0177] [Fig. 168] FIG. 168 is a side view of the cassette base of FIG.

[0178] [Fig. 169] FIG. 169 is an end view of the cassette base of FIG.

[0179] [Fig. 170] FIG. 170 is a side view of the cassette base of FIG.

[0180] [Fig. 171] FIG. 171 is a perspective view of the cassette collar of FIG.

[0181] [Fig. 172]FIG. 172 is a perspective view of the cassette collar of FIG.

[0182] [Fig. 173] FIG. 173 is an end view of the cassette collar of FIG.

[0183] [Fig. 174] FIG. 174 is a side view of the cassette collar of FIG.

[0184] [Fig. 175] FIG. 175 is an end view of the cassette collar of FIG.

[0185] [Fig. 176] 176 is a side view of the cassette collar of FIG. 164. FIG.

[0186] [Fig. 177] FIG. 177 is a perspective view of the cassette ring of FIG.

[0187] [Fig. 178] FIG. 178 is a perspective view of the cassette ring of FIG.

[0188] [Fig. 179] FIG. 179 is an end view of the cassette ring of FIG.

[0189] [Fig. 180] FIG. 180 is a side view of the cassette ring of FIG.

[0190] [Fig. 181] FIG. 181 is an end view of the cassette ring of FIG.

[0191] [Fig. 182] FIG. 182 is a perspective view of the cassette foot of FIG.

[0192] [Fig. 183]FIG. 183 is a perspective view of the cassette foot of FIG.

[0193] [Fig. 184] 184 is an end view of the cassette foot of FIG. 164. FIG.

[0194] [Fig. 185] FIG. 185 is a side view of the cassette foot of FIG.

[0195] [Fig. 186] 186 is an end view of the cassette foot of FIG. 164. FIG.

[0196] [Fig. 187] FIG. 187 is a perspective view of the cassette nut of FIG.

[0197] [Fig. 188] FIG. 188 is a perspective view of the cassette nut of FIG.

[0198] [Fig. 189] FIG. 189 is an end view of the cassette nut of FIG.

[0199] [Fig. 190] FIG. 190 is a side view of the cassette nut of FIG.

[0200] [Fig. 191] FIG. 191 is an end view of the cassette nut of FIG.

[0201] [Fig. 192] FIG. 192 is a cross-sectional view taken along line JJ in FIG.

[0202] [Fig. 193] FIG. 193 is a perspective view of the cassette holder of FIG.

[0203] [Fig. 194]FIG. 194 is a perspective view of the cassette holder of FIG.

[0204] [Fig. 195] FIG. 195 is an end view of the cassette holder of FIG.

[0205] [Fig. 196] FIG. 196 is a side view of the cassette holder of FIG.

[0206] [Figure 197] FIG. 197 is an end view of the cassette holder of FIG.

[0207] [Figure 198] FIG. 198 is a perspective view of the cassette holder of FIG.

[0208] [Figure 199] FIG. 199 is a perspective view of the drive ribbon of FIG.

[0209] [Figure 200] FIG. 200 is a perspective view of the drive ribbon of FIG.

[0210] [Figure 201] FIG. 201 is a side view of the drive ribbon of FIG.

[0211] [Fig. 202] FIG. 202 is an end view of the drive ribbon of FIG.

[0212] [Fig. 203] FIG. 203 is a view of the exterior of the drive ribbon of FIG. 164 when laid down.

[0213] [Fig. 204] FIG. 204 is an edge view of the drive ribbon of FIG. 164 when laid down.

[0214] [Fig. 205] FIG. 205 is a view of the inside of the drive ribbon of FIG. 164 when laid down.

[0215] [Fig. 206] FIG. 206 is an enlarged view of a portion of the drive ribbon shown in detail J of FIG.

[0216] [Fig. 207] FIG. 207 is an enlarged view of a portion of the drive ribbon shown in detail K of FIG.

[0217] [Fig. 208] FIG. 208 is an exterior view of two drive ribbons of FIG. 164 joined together and laid down for illustrative purposes.

[0218] [Fig. 209] FIG. 209 is a view of the inside of two drive ribbons of FIG. 164 joined together and laid down for illustrative purposes.

[0219] [Fig. 210] FIG. 210 is an enlarged view of a portion of the drive ribbon shown in detail L of FIG.

[0220] [Fig. 211] FIG. 211 is an enlarged view of a portion of the drive ribbon shown in detail M of FIG.

[0221] [Fig. 212] FIG. 212 is a schematic diagram of a control system for controlling the dosage delivered by the device.

[0222] [Fig. 213] FIG. 213 is a schematic diagram of another control system for controlling the dosage delivered by the device.

[0223] [Fig. 214] FIG. 214 is a schematic plan view of the control system of FIG.

[0224] [Fig. 215] FIG. 215 is a schematic diagram of another control system for controlling the dosage delivered by the device.

[0225] [Fig. 216] FIG. 216 is a schematic diagram of an alternative physical layout of the control system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0226] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrative examples are illustrative of embodiments of the present disclosure, which in some forms may be implemented as disclosed below. The embodiments described are not intended to be exhaustive or to limit the scope of the invention to the precise forms disclosed. It is not intended to be interpreted as construing or interpreting the principles set forth herein.

[0227] Examples of drug delivery devices are provided. One advantage is that such delivery devices are It may be possible to provide a configuration having a relatively short length and a compact configuration. In some embodiments, the device can be used to deliver insulin or other drugs, for example for the treatment of diabetes. or other types of drugs, such as auto-injectors having a syringe pre-filled with the drug. In some embodiments, the device is a disposable device. The cartridge can be replaced with another cartridge containing new and / or different medication. a disposable syringe cartridge removably coupled to the drive housing so that the syringe cartridge can be The drive housing is adapted for on-board and / or off-board stages in drug delivery. The device may include electronics for sensing, indicating, displaying, and / or communicating with the device.

[0228] The illustrated device is an axially expanding device as part of a drive assembly for dispensing a drug. As can be seen with reference to FIGS. 1-3, an exemplary embodiment The drive ribbon of the drive ribbon 22 has a stored configuration in which a stored portion of the drive ribbon 22 defines a spiral; The expanded portion of the drive ribbon 24 has an expanded configuration that defines a helix.

[0229] As used herein, the stored portion 22 of the drive ribbon defines the proximal end and is the drive The opposite end of the expanded portion 24 of the drive ribbon defines a distal end. and the expanded configuration to vary the length of the expanded portion 24. When the drive ribbons are shifted to the extended configuration, the ribbons form into a helix, When the proximal edge region of the ribbon engages the distal edge region of the ribbon, the ribbon is secured to itself. do.

[0230] Figures 1-3 show several different ways the drive ribbons can function. FIG. 1 illustrates the extended portion 24 of the drive ribbon moving forward without rotation of the extended portion 24. 2 is a schematic representation of the drive ribbon 26. In such an embodiment, the extended drive ribbon As the retracted portion advances axially, the distal edge of the retracted ribbon meets the expanded portion of the ribbon. The proximal retracted portion of the ribbon is adapted to engage the proximal edge of the ribbon at the bottom of the , is drawn radially inward and upward. The ribbon is drawn radially inward and upward. The cam ramps engaging the proximal edge of the retracted ribbon are used to guide the guide in this motion. It can be id.

[0231] One advantage of such a non-rotating drive ribbon is that the bearings attached to the distal end of the ribbon The bearing member does not rotate, and therefore there is no relative rotational movement between the bearing member and the piston. This means that the piston can be supported directly on the agent container piston.

[0232] 2 and 3 show the drive ribbons 28, 30 which rotate as they are axially expanded. 2 and 3. The difference between the ribbon shown in FIG. 2 and the ribbon shown in FIG. 3 is the manner in which the distal and proximal edges of the ribbon engage. 28 has edges that project inwardly and outwardly to form a protruding lip. is shown in Figures 7-9 and 33 described below.

[0233] Drive ribbon 30, similar to ribbon 26, forms a more cylindrical shape with the proximal edge and The distal and proximal edges may not protrude or may be significantly larger than the inner and outer surfaces of the expanded portion 24 of the ribbon. The drive ribbons shown in Figures 4-6 and 11 are designed to have this type of engagement. These are further described below.

[0234] Rotating drive ribbons allow for a greater variety of drive ribbon configurations than non-rotating drive ribbons. However, rotation of the drive ribbon is generally achieved by the bearing members being mounted on the drive ribbon. A bearing member is attached to the secondary component and engages the piston of the drug container relative to the drive ribbon. This requires that the piston be able to rotate with the bearing member. This allows the bearing member to engage the piston of the medication container without any relative movement. This configuration also allows for an increase in the overall length of the drive ribbon assembly.

[0235] Due to the short axial length of the retracted portion of the drive ribbon, the use of such a drive ribbon The present invention relates to an injection device or similar drug delivery device having a relatively short and compact size. Various options for moving the drive ribbons and device architectures Various different drive assemblies are disclosed herein and described below.

[0236] Exemplary Drive Ribbon A driven ribbon that forms a generally cylindrical extended portion (similar to the ribbons of FIGS. 1 and 3). An example of a ribbon 32 is shown in Figures 4-6. During use, the ribbon 32 assumes the shape shown in Figure 4. The ribbon 32 is not shown in this configuration, but is merely illustrated to aid in understanding the structure of the ribbon 32. Material 34 is secured to the distal end of ribbon 32. When ribbon 32 is used in a non-rotating application, In this case, the legs 34 can be supported directly against the piston of the drug container. , including a central bore that can function as a rotatable bearing. For example, the central bore of leg 34 The bearing member having a protrusion that fits into the leg 34 is rotatably attached to the leg 34 and replaces the leg 34. This configuration allows the piston to be supported directly on the drive ribbon as it advances axially. This facilitates the use of ribbon 32 in applications where the ribbon 32 rotates.

[0237] The ribbons 32 are engageable with one another and are shown in more detail in Figs. The distal edge portion 36 faces inward and has a proximal edge portion 38. The distal edge portion 36 faces inward and has a The recess 40 is disposed between a protruding lip 42 and an inner protruding shelf 44. The lip 42 also includes , a series of notches 46. The inwardly facing surface of ribbon 32 also includes a series of raised ribs 48. The ribs 48 may be coupled to gears or similar drive members to rotatably drive the movement of the ribbon 32. The locking mechanism can be engaged by a material mechanism.

[0238] The proximal edge portion 38 can be seen in FIG. 6, and the outwardly facing surface of the ribbon 32 is Along the proximal edge is a lip 50 and a recess 52. An axially extending rib 54 is disposed within the recess 52. When the proximal and distal portions of ribbon 32 engage with one another, lip 50 The lip 42 and shelf 44 restrain the axial movement of the recess 40 to fit within the recess 40. Similarly, lip 42 fits within recess 52 and is consequently axially restrained. Engagement occurs when the expanded portion of ribbon 32 urges the piston forward to expel the drug. The ribbon is expanded by exerting an axial compressive force on the This makes it possible to prevent the attached part from coming off of itself due to being pulled apart in the axial direction. The ribs 54 provide shear resistance and support when the expanded portion of the ribbon is rotated. The bolt fits within notch 46 to enable it to withstand the torque that may be applied.

[0239] Proximal and distal edges that form a protruding lip when engaged (similar to the ribbon in FIG. 2) An example of a drive ribbon having a sidewall that is slightly conical when in the extended position is shown in FIG. 7-9. Ribbon 56 is shown lying on a flat surface in FIG. 8 and 9 provide a more detailed view of ribbon 56.

[0240] The drive ribbon 56 is configured to extend along the length of the ribbon 56 as the ribbon 56 expands to form a helix. It includes a recessed area 58 along the proximal edge portion of the ribbon 56 which receives an adjacent portion of the distal edge portion. However, the recessed portion 58 does not receive the entire thickness of the distal edge portion. and a portion of both the proximal edge portion protrude in radially opposite directions.

[0241] A plurality of pegs 60 are disposed within the recesses 58 and engage a corresponding plurality of holes 62. In an embodiment, the pegs 60 are located at the proximal edge portion and the holes 62 are located at the distal edge portion. However, in other examples, these positions can be reversed. When tensioned and formed into a helix, the engagement of the proximal edge portion with adjacent portions of the distal edge portion forms a In the illustrated embodiment, the peg 60 is engaged with the hole 62. It has a chamfered tip surface which facilitates entry and removal of the 0.

[0242] The engagement of the pegs 60 with the holes 62 axially secures adjacent portions of the drive ribbons 56 together. The engagement of the pegs 60 with the holes 62 also provides for the transfer of torque between adjacent portions of the expanded ribbon. and maintains the stability of the column formed by the expanded ribbon.

[0243] In the illustrated embodiment, the drive ribbon 56 has a number of recesses 64 that provide a geared surface. The recess 64 is engaged by a gear member or other suitable drive member, thereby The drive assembly rotates the drive ribbon 56 by transmitting a rotational force to the drive ribbon 56. As can be seen in FIG. 7, the drive ribbon 56 is formed into a helix. When the drive ribbon is engaged, a bearing member such as leg 34 that defines the distal end of the drive ribbon and is attached thereto is engaged. The tapered portion 66 has a

[0244] The drive ribbon shown has flexible ribbons machined to define the various features of the ribbon. Uses polymer ribbons. Nylon, polypropylene, acetal (polyoxymethylene) Polyethylene (POM or POM), and high density polyethylene are used to form the drive ribbons. are examples of suitable polymeric materials that may be used. An alternative embodiment uses a molding process to produce a polymer ribbon having all of the characteristics. After the ribbon is formed in a flat configuration, the ribbon can be rolled into a spiral configuration. It is anticipated that rolling the ribbons into a single piece will be the most efficient manufacturing method for forming the ribbons.

[0245] Other materials may also be used to form the drive ribbon. For example, thin metal strips. Lips can be used to form ribbons. Photo-etching, laser etching Micromachining, or other suitable micromachining methods are used to shape the individual features of the ribbon. Alternatively, metal ribbons can be used instead of using a single metal strip. Alternatively, it may be formed by diffusion bonding two half-thickness layers.

[0246] Yet another ribbon embodiment takes the form of an overmolded metal strip. The metal strip may include distal edge features and may be overmolded onto the ribbon. The plastic parts that are bonded to the ribbon will form various features of the ribbon. Desirable stiffness, elasticity, and creep resistance of the alloy combined with low friction and molded plastics The ribbon is flexible and easy to manufacture, with small features that can be easily formed without permanent deformation. The lever is adapted to be able to be extended and retracted and to undergo the associated elastic strains. It is generally desirable for the bone to be flexible.

[0247] In this regard, various embodiments disclosed herein may be used with disposable devices or multiple It can be either a single-use device, some of the devices are one-use or the other. Note that optimally, multi-use devices require a new drug container after the drug container is depleted. It can be expanded and stored multiple times so that it can be reused with new drug containers. The disposable drive ribbon is used by only a single drug container. Such disposable drive ribbons are used in the suction tube and are discarded once expanded. It is not necessary that the drive ribbons have the ability to resist axial tension and therefore The ability of the extended portion of the ribbon to resist axial separation is determined by the following: And it is most important when the drive ribbon is exposed when it is extended. These concerns are being reduced, if not eliminated, at least in some applications, by disposable drive ribbons. There is little need for the extended portion of the drive ribbon to have the ability to resist axial separation forces. This is also fine.

[0248] Non-rotating driven ribbon 10-21 are diagrams illustrating a device having a drive ribbon that does not rotate as it advances axially. Such a drug delivery device has a container body that holds the drug and defines an outlet. The container is suitable for use with a container that includes a piston disposed within a container body, Advancement of the piston within the vessel body expels the drug through an outlet (e.g., a hollow needle). The vice includes a housing adapted to be coupled to the container and a pressure sensor coupled to the housing and adapted to detect the container. and a drive assembly adapted to advance the piston within the vessel. The drive ribbon includes a distal edge portion and a proximal edge portion. The drive ribbon has a stored configuration and and an extended configuration, wherein a retracted portion of the drive ribbon in the retracted configuration defines a spiral; The expanded portions of the drive ribbons in the expanded configuration define a helix. The drive ribbons are progressively movable from the retracted configuration to the extended configuration. The drive ribbon defines a drive shaft and advances the piston within the vessel body. or moving from the retracted configuration to the extended configuration without rotating relative to the container. The drive ribbon is engaged with the housing. The thrust member is connected to both the drive ribbon and the housing. Rotation of the thrust member moves the drive ribbon from the retracted configuration to the extended configuration. Move.

[0249] Non-rotating drive ribbon with stationary thrust member In some embodiments having such a non-rotating drive ribbon, the thrust member Such axially stationary thrust members are engageable with the drive ribbons. The device may further include a rotational restraining member, The rotational constraint member is rotationally fixed relative to the housing and engages the drive ribbon. The engagement of the ribbon and the rotational constraint member is achieved by the expansion of the drive ribbon and the rotational constraint member. Prevents counter rotation.

[0250] In such devices having rotational constraint members, one of the rotational constraint members and the drive ribbon are expanded. The tensioned portion defines an axially extending key, and the other of the rotation restraining member and the extended drive ribbon are The recessed portion defines an axially extending keyway.

[0251] The rotational constraint member is in an engaged position where the rotational constraint member engages the drive ribbon to prevent rotation. For example, the drive ribbons 10 and 11 may be arranged radially outward of the drive ribbons 10 and 11. 12 and 13, and the embodiment of FIG. 16 and FIG. 17. I want to be illuminated.

[0252] Alternatively, the rotational constraint member may be in a position where the rotational constraint member engages the drive ribbon to prevent rotation. For example, the drive ribbons may be disposed radially inward of the drive ribbons in FIG. Please refer to the embodiments.

[0253] For embodiments having an axially stationary thrust member with a helical thread, the helical thread may be , disposed radially outward of the drive ribbon at a location where the helical thread engages the drive ribbon. For example, the embodiments of Figs. 10 and 11, 12 and 13, and See the embodiment of Figures 14 and 15. Alternatively, the helical screw may be driven by It may be disposed radially inward of the drive ribbon at a location that engages the ribbon. For example, See the embodiments of FIGS.

[0254] Referring now to the embodiment of Figures 10 and 11, this embodiment includes a drive ribbon 7 The rotational constraint member 68 includes a tab 72 disposed radially outward of the rotational constraint member 68. , engages with an axially extending slot 73 defined within the expanded portion of the drive ribbon 70. The restraining member 68 is fixed relative to the housing and defines an engagement position 75. The gasket is also capable of supporting the drug container without relative movement between the housing and the container. Thus, the tabs 72 regulate the expansion of the drive ribbon 70 relative to the housing and drug container. As a result, the bearing members or legs 74 are secured to the drive ribbon 70 to prevent rotation of the tensioned portion. It can be fixed.

[0255] The thrust member 76 includes a groove 80 that forms a helical shape in the expanded portion of the drive ribbon 70. The thrust member 76 and the screw 78 rotate. They then pull the drive ribbon 70 from its stored configuration 69 to its extended configuration 71. The screw 78 also exerts an axial force on the ribbon 70, thereby The piston 70 can exert a biasing force on the drug container piston via the legs 74 to dispense the drug. Cut.

[0256] The thrust member 76 is axially stationary and rotatably attached to the restraining member 68. More specifically, the thrust member 76 is rotatable relative to the rotation constraint member 68. and is axially captured by rotational restraint member 68 and cannot move axially relative thereto. This is best understood with reference to FIG. 11. The thrust member 76 is a helical screw. The bearing includes an axially extending cylindrical portion 77 in which a screw 78 is disposed. A radially extending flange 79 The rotation restraining member 68 is disposed at one end of the portion 77. When the rotation restraining member 68 is inserted into the groove 67, the thrust 7. Receiver flange 79 prevents member 76 from axial movement relative to restraining member 68. The engagement between the thrust member 76 and the rotation restriction member 68 is caused by the inclination of the flange 79. It is a snap-fit ​​type engagement facilitated by the beveled outer radial surface 79A. Surface 79 cams radially inwardly while thrust member 76 is engaged with rotational constraint member 68. It functions as an inclined biasing flange 79 .

[0257] A drive gear or other suitable drive member is provided on the outer radial surface 76A of the thrust member 76. For example, the thrust member 76 is engaged with the thrust member 76 at a position such as the center of the shaft 71, and the thrust member 76 is driven to rotate. The outer radial surface 76A engages the motor drive gear, thereby driving the thrust member 76. It may be a geared surface that causes it to rotate.

[0258] The embodiment of Figures 12 and 13 has the same general structure as the embodiment of Figures 10 and 11. However, the embodiment of Figures 12 and 13 has a drive ribbon 82. 82. An external cam 86 is engaged with an axially extending slot in the rotation restraining member 86 to prevent rotation of the external cam 82. The difference is that the roll has a tab or post 84 extending therethrough. The use of tab 84 allows for a roll shape Axially aligned stripes on the drive ribbons can be difficult to form using a fabrication process. Avoid using lots.

[0259] The embodiment of Figures 14 and 15 has a helical shape in the expanded portion of the drive ribbon 88. The ribbon 88 also has a groove on its outer surface. The enlarged portion of the shaft has an axially extending groove.

[0260] The rotational restraining member 90 is disposed radially inward of the drive ribbon 88 and is attached to the inner surface of the ribbon 88. Engages with groove to define engagement location 93 to prevent rotation of expanded portion of drive ribbon 88 It includes an axially extending rib 92 .

[0261] An axially stationary thrust member 94 is disposed radially outward of the drive ribbon 88 and supports the The helix engages with a groove on the outer surface of ribbon 88, which takes on a helical shape in the expanded portion of ribbon 88. As the thrust member 94 rotates, it drives the ribbon 88 out of its stored configuration. It can be pulled into its expanded configuration, exerting an axial force on the drive ribbon 88 .

[0262] The embodiment of Figures 16 and 17 defines a helical shape in the expanded portion of the drive ribbon. A drive ribbon having an internal groove 99 and an external groove extending axially through the expanded portion of the drive ribbon. It has 98.

[0263] The rotation restraining member 100 is disposed radially outward of the ribbon 98 and in the axial direction of the ribbon 98. Engage with an extending external slot to define an engagement position to prevent rotation of the ribbon 98. The thrust member 104 includes a rib 102. The thrust member 104 is rotatably mounted on the shaft. The thrust member 104 and the screw 106 rotate. , as they rotate, pulling ribbons 98 into an expanded configuration. Screws 106 also rotate ribbons 9 An axial force is exerted on 8.

[0264] 18 and 19 show a rotational constraint member that engages with a slot to prevent rotation of the ribbon. 1 shows two drive ribbons 108, 82 including radially outwardly extending projections extending from each other. As can be seen from FIGS. 12 and 13, the drive ribbons 82 are arranged in the axial and circumferential directions. The drive ribbon 108 of FIG. circumferentially separated but substantially axially connected due to the extended portion of the drive ribbon. The plate has an elongated rib 110 connected thereto.

[0265] Non-rotating drive ribbon having axially movable thrust member In some embodiments having a non-rotating drive ribbon, the thrust member may be When the thrust member rotates, the distal end of the drive ribbon moves axially in the proximal direction P. The piston remains stationary axially when the piston is in the container body. The expanded portion of the member and drive ribbon is axially displaced in a distal direction D opposite the proximal direction. An example of such a device is shown in Figures 20 and 21. The orientation of distal use is consistent throughout this disclosure.

[0266] The device further includes a thrust member that exerts tension as the thrust member rotates to extend the drive ribbon. When the ribbon expands, the thrust member can include a drive spring that is adapted to move the ribbon in a proximal direction. The distal end of the drive ribbon moves axially at 100° C. while the distal end of the drive ribbon remains stationary. To do this, the thrust member and the drive spring are released, and the drive spring drives the thrust member. The drive ribbon is then advanced axially with the expanded portion of the ribbon. A piston is advanced within the drug container to dispense the drug.

[0267] The embodiment of FIG. 20 has an axially movable thrust member 112. 12 includes a helical thread 114 engageable with a drive ribbon 124, the helical thread 114 being a helical The screw is disposed radially inward of the drive ribbon 124 at a location where the screw engages the drive ribbon. The rotational constraint member 122 is configured such that engagement between the drive ribbon and the rotational constraint member inhibits the expansion of the drive ribbon 124. relative to the housing to prevent relative rotation between the tensioned portion and the rotation restriction member 122. It is rotationally fixed and engaged with the drive ribbon 124 .

[0268] The threads 114 of the thrust member 112 engage helical grooves on the inwardly facing surface of the drive ribbon 124. The thrust member 112 has a central bore defining a central shaft 118 therein. The thrust member 112 has a hollow center. The thrust member 112 has a central bore that engages with a helical groove in the shaft 118. The thrust member 112 rotates on a shaft 118. As it moves proximally, it compresses the drive spring 120. FIG. 1 shows a thrust member.

[0269] Shaft 118 extends further proximally of the drive assembly than is shown in FIG. A locking mechanism can be engaged to prevent axial movement of the shaft 118. The member 112 is rotated and moved proximally to compress the spring 120, and then the shaft 118 is 120. The thrust member 112 and the spring 120 can then be released. The spring 120 then biases the thrust member 112 in the distal direction. The threads 114 of the member 112 advance the drive spring 120 distally with the thrust member 112. To make.

[0270] The embodiment of FIG. 21 includes an axially movable thrust member 126, which , a helical thread 128 engageable with a drive ribbon 130, the helical thread 128 being The drive ribbon 130 is disposed radially outward of the drive ribbon 130 at a position where the drive ribbon 130 engages the drive ribbon. The engagement between the drive ribbon 130 and the rotational constraint member 132 is 0 and the rotation restriction member 132. 1 and 2. The drive ribbon 130 is rotationally fixed relative to the drive ribbon 130 .

[0271] The thrust member 126 is shown in FIG. 1 so that it threadably engages the housing in a releasable manner. The thrust member 1 may extend radially outwardly much further than shown at 21. As 26 rotates relative to the housing, it moves proximally, compressing drive spring 134. In FIG. 21, the thrust member is shown after it has been rotated to retract proximally. Reference numeral 127 is used to identify the location of thrust member 126. After retracting 126, it can be released, which also releases drive spring 134. , thereby urging spring 134 to axially advance thrust member 126 in the distal direction. The screw 128 of the thrust member 126 drives the drive ribbon 130 distally with the thrust member 126. The piston is then advanced axially in a direction that advances the drug reservoir piston to dispense the drug.

[0272] Rotatable drive ribbon 22-45 relate to drive ribbons that rotate as they advance axially. Such ribbons are used with containers having a container body that holds a medicament and defines an outlet. The container may be disposed in the container body. The container body includes a piston, the advancement of the piston within the container body expels the medicament through the outlet. The delivery device includes a housing adapted to be coupled to the container and a and a drive assembly adapted to advance the piston within the container. The assembly includes a drive ribbon having a distal edge portion and a proximal edge portion. a retracted portion of the drive ribbon in the retracted configuration defining a spiral; The expanded portions of the drive ribbons in the expanded configuration define a helix. The actuator is movable from the stored configuration to the extended configuration, and the actuator is movable from the stored configuration to the extended configuration. The movement of the drive ribbon defines a drive axis. The drive ribbon rotates as it moves from the retracted configuration to the extended configuration. To rotate.

[0273] 22-24 show the radius of the drive ribbon so that the drive member engages and rotates with the drive ribbon. a fixed component having a helical thread disposed radially outward of the drive ribbon; The helical threads of the stationary component engage the drive ribbon and are in a retracted configuration. It controls the movement of the drive ribbons to and from the extended configuration.

[0274] FIG. 22 illustrates how the drive member 136 engages a groove on the inward facing surface of the drive ribbon 140 to drive the ribbon. The assembly has a pair of keys 138 which drive rotation of the collar 140. 2 is fixed relative to the housing and engages with a spiral groove on the outwardly facing surface of the drive ribbon 140. The axially extending portion includes a mating helical thread 144 .

[0275] Figures 23 and 24 show an assembly very similar to that shown in Figure 22. However, the drive members 146 engage corresponding surfaces on the inner surface of the drive ribbon 150 to define the engagement position. The recess 144 has a number of keys 148 which engage with a number of grooves in the recess 144 .

[0276] As the drive ribbon 150 advances axially, it rotates, causing the drive ribbon 150 to A first member 154 that is fixed and that is rotatable relative to the first member 154 and the ribbon 150. A rotatable bearing assembly 152 having a second member 156 that can rotate around the second member 156 is used. The member 156 is directly connected to the piston of the drug container without rotating relative to the piston. While being capable of supporting the first member 154 and the ribbon 150, both As the piston advances, it rotates relative to the member 156 and the piston, and the member rotates relative to the piston. 156 is energized to move the piston forward.

[0277] 25 and 26 show a radial groove in the drive ribbon for engaging and rotating the drive ribbon. FIG. 25 shows an alternative drive arrangement using a single gear member 158. 26 illustrates the use of multiple gears 160. Gears 158, 160 engages an axially extending groove or raised rib (not shown) on the inner surface of the drive ribbon. Such grooves / ribs correspond to the distance between the gear teeth of the gear used by the ribbon. The electrodes are spaced apart by a distance that determines the distance between the electrodes.

[0278] 27-41 relate to embodiments having rotatable drive ribbons, and the radius of the drive ribbons A drive member disposed in the outer direction engages with the drive member to drive it to rotate.

[0279] FIG. 27 illustrates diagrammatically the use of a single ring gear 162 with a drive ribbon 164. The ring gear 162 completely surrounds the drive ribbon 164 and is aligned with a portion of the outer surface of the drive ribbon 164. The central opening of the ring gear 162 is larger than the outer diameter of the drive ribbon 164. , therefore, a portion of the circumference of the drive ribbon is not engaged by the ring gear 162. 28 and 29 show diagrammatically the use of multiple ring gears. In this state, the two ring gears 166 engage the drive ribbon 164. 6, the entire circumference of the drive ribbon 164 is engaged by the ring gear. As can be seen in FIG. 29, the ring gear 166 is axially offset. The device of FIG. 29 also includes a helical screw 164 that engages with a groove on the inner surface of the drive ribbon 164. The ring gear 166 advantageously includes a spindle member 168 having a thread 170. A ring gear 166 engages the outer surface of the drive ribbon near where the ring gear 166 engages the inner surface of the drive ribbon. The plates are arranged axially so that the plates are aligned in the axial direction.

[0280] Alternatively, various other types of drive members may be used to drive the drive ribbon in rotation. FIG. 30 shows the belt 172 engaging the outer surface of the drive ribbon 174 to rotate the drive ribbon. 1 shows the use of a belt drive arrangement to rotate the drive shaft 176 or other suitable A suitable mechanism drives the belt 172.

[0281] Multiple planetary gears may also be used to rotate the drive ribbon. 32 and 33 show the use of a planetary gear 178 which is also a speed gear, whereas FIG. 32 and FIG. 33 show the use of a planetary gear 178 which is also a speed gear, whereas FIG. 33 shows a slightly different embodiment having planetary gears 180. As can be seen in FIG. The planetary gears 180 engage the outer surface of the drive ribbon 184 while the helical threads 182 rotate the drive ribbon. 7-9, the drive ribbon 184 engages the inwardly projecting proximal end of the drive ribbon 184. The moving ribbon 184 has an outwardly projecting edge with which the drive ribbon engages.

[0282] Figures 34 and 35 show an alternative drive arrangement that uses a worm gear to rotate the drive ribbon. In FIG. 34, a pair of worm gears 186 engage the outer surface of a drive ribbon 188. 35 shows a single drive ribbon 188 rotating. FIG. 1 shows a drive configuration in which a single worm gear 190 is used. This reduces the complexity and number of parts compared to using two worm gears, but the drive A pair of worm gears on opposite sides of the ribbon allows for more uniformity on the drive ribbon. Provide a balanced distribution of forces.

[0283] 36-41 relate to the use of a keyed drive to drive rotation of the drive ribbon. FIG. 36 illustrates a plurality of axially extending keys or links when the drive ribbon 192 is in an expanded configuration. 1 shows a drive ribbon 192 having ribs 194. The ribs 194 are aligned with keyways on the drive member. 37 shows a driven ribbon 192. The bone 196 has a number of keyways or slots 198 extending axially therethrough when in an expanded configuration. 1 shows a drive ribbon 196 having a slot 198 that fits over a key or similar on the drive member. The projections can be engaged to drive and rotate the ribbon 196.

[0284] Figures 38 and 39 show examples of key drive configurations. The moving member 200 includes a plurality of axially extending slots that engage with the outer surface of the drive ribbon 204. The drive member 200 has a rib or key 202. As the drive member 200 rotates, the drive ribbon 204 also rotates. The fixed spindle member 206 has a helical thread 204 which engages with a groove on the inner surface of the drive ribbon 204. It has 08.

[0285] Figures 40 and 41 show another example of a key drive arrangement. In this arrangement, the drive member 210 engages with an axially extending slot on the outer surface of the drive ribbon 214 to rotate the ribbon 214 The stationary collar member 216 includes a plurality of ribs or keys 212 that drive the drive ring 214 to rotate. The bone 214 includes a helical thread 218 that engages with a groove on the outer surface of the bone 214 .

[0286] The non-engaged portion of the drive ribbon is used by the drive member 42-45 show a container for use with a container having a container body that holds a medicament and defines an outlet. The present invention relates to a drug delivery device for use in a patient, the container comprising a piston disposed within a container body. Advancement of the piston within the container body expels the medicament through the outlet. A housing adapted to be coupled to the container; and a piston coupled to the housing and disposed within the container. and a drive assembly adapted to advance the distal end of the drive assembly. The drive ribbon includes a retracted configuration and an extended configuration having a proximal edge portion and a distal edge portion. a retracted portion of the drive ribbon in the retracted configuration defining a spiral, and The extended portions of the drive ribbons in the containment structure define a helix. Movement of the drive ribbon from the retracted configuration to the extended configuration. defines a drive shaft and advances the piston within the vessel body. The drive ribbon is adapted to be adapted to move from a stored configuration to a When moving to the extended configuration, the drive ribbon also rotates. and a distal edge portion and a proximal edge portion of the drive ribbon define a transition portion disposed between the distal edge portion and the proximal edge portion of the drive ribbon. The drive member engages the drive ribbon to drive the drive ribbon. Upon rotation, the drive member engages the stored or transition portion of the drive ribbon.

[0287] Storage bobbin drive member FIG. 42 illustrates a device that includes a storage bobbin 220 that holds a stored portion of a drive ribbon 222. The portion of the drive ribbon 222 disposed within the storage bobbin 220 is The storage bobbin 220 is then expanded radially outward to engage with the storage bobbin 220. As the drive ribbon 222 rotates, the drive ribbon 222 also rotates. 4. The collar member 224 can be used to engage the drive ribbon 222. 222 engages with a groove on the outer surface of the ribbon 222 to control and guide the ribbon 222 into engagement with itself, The ribbon 222 includes a helical thread 226 that axially expands the ribbon 222 by rotating the bobbin in the opposite direction. Note that rotation of 220 can be used to cause ribbon 222 to retract. Similarly, for nearly all drive member mechanisms disclosed herein, unless otherwise specified: The drive member mechanism is operated in reverse to extend the drive ribbon as well as retract it. It is possible.

[0288] Reciprocating Drive Member FIG. 43 shows the transition 231 of the drive ribbon between the retracted and extended portions. 43 shows the reciprocating drive member 228 engaging the drive ribbon 230. Thus, the reciprocating drive members 228 engage the radially inwardly facing surfaces of the drive ribbons 230. In some embodiments of member 228, the cyclical movement of member 228 and the nature of its engagement can drive ribbon 230 to its extended position, but cannot drive ribbon 230 to its retracted position. This results in the member 228 being unable to be driven into position.

[0289] Worm Gear FIG. 44 shows how the worm gear 232 rotates the drive ribbon 23 at the retracted portion of the drive ribbon. 4 is shown.

[0290] Reciprocating ratchet drive Referring now to FIG. 45, for embodiments having a reciprocating drive member, the reciprocating drive member 23 6 in a first direction and an opposite second direction as indicated by double arrow 242. The drive member 236 can take the form of a drive member that moves in a first direction 243. 23 and 24. The drive member 236 and the drive ribbon 238 are arranged to move relative to each other in the first direction 24. does not allow relative motion between the drive member 236 and the drive ribbon 238 at 1 (or at least one drive ribbon 238 engageable with the drive ribbon 238 configured to It is shown including one flexible ratchet member 244. It moves in a second direction 241. When the drive member 236 is pressed against the drive ribbon 238, the drive member 236 moves the drive ribbon 238. When moved in the first direction 243, the ratchet member 236 moves onto the drive ribbon 238. repositioned, thereby pushing the ribbon forward as it moves in the second direction 241 again. The illustrated embodiment also provides a drive ribbon that does not move relative to the housing. A fixed ratchet including a plurality of ratchet members 244 that engage the radially outwardly facing surfaces of the When the reciprocating drive member 236 is moving in a first direction 243, the reciprocating drive member 236 is The ratchet member 240 is pulled rearward by the drive ribbon 238 reciprocating ratchet member 236. The ratchet drive shown in Figure 45 ensures that the ribbon is not stretched. Such devices are well suited for use in disposable devices that are inserted but not subsequently stored. If it is desired to use a ratchet drive in a multi-use device, the ratchet portion The members 236 and 240 must be movable out of engagement with the drive ribbons. A second drive mechanism is used to rotate the drive ribbon in the opposite direction. 236, as well as an oscillating escapement drive for generating the reciprocating motion of the drive member 228 as described above. can be used.

[0291] Device Architecture The various ribbon and drive member mechanisms disclosed herein can be used to provide a drug delivery device. These devices can be combined in many ways to achieve the two most common The categories are those with inline architecture and those with dual-axis architecture. These two basic architectures are shown in Figures 46-54.

[0292] Inline Architecture A device with an in-line architecture is shown in Figures 46-48. The configuration includes a drive ribbon R and a drive member mechanism used to drive the extension of the drive ribbon. Both of the structures share a common axis 246. As shown in FIG. Dial knob DK used to set the dose and injection that initiates the extension of the drive ribbon and button B. The device also holds a medication container 248. The illustrated container 248 includes: A glass barrel for holding the drug, a piston 250 disposed within the barrel, and a hollow injection needle 252 is a conventional syringe cartridge having an outlet defined by a drive ribbon. As R expands, a bearing member 254 disposed at the distal end of ribbon R bears against piston 250. 248. The catheter supports the catheter 248 and advances a piston 250 within the reservoir 248, thereby forcing the drug through a needle 252. Release the agent.

[0293] Dual Axis Architecture Figures 49-54 provide simplified diagrams of dual-axis devices. Figures 55-132 show The figures following Figure 132 provide a more detailed schematic of the dual-axis device. A needle 252, a container 248, a dial knob DK, a drive ribbon R and an injection button are provided. References to common components such as Tan B are used throughout the figures for different device configurations. As will become apparent from the following description, the dual-axis device is driven by a drive ribbon. A secondary axis is defined that is parallel to and offset from the primary drive axis. One advantage of the two-axis device is that a portion of the drive member mechanism is The offset from the axis causes the drive member mechanism to extend distally parallel to the primary axis. This means that such a two-axis device can be arranged The mechanism can have an overall shorter length than if the entire mechanism were aligned with the main axis. To perform.

[0294] As can be seen from Figures 49-54, the dual-axis architecture allows for Beyond that, we can increase the majority of the devices, called here 253, Patients with dexterity or difficulty coping due to a debilitating disease or condition The device 253 shown in Figures 49-51 can be advantageous for It is used to dispense medication from a 3 ml syringe cartridge and defines a first axis 254. and a drive member mechanism defining a secondary parallel axis 256. 52-The device shown in FIG. 54, referred to herein as 253', also incorporates a conventional 3 ml A drive ribbon for dispensing a drug from a syringe cartridge and defining a first axis 254; and a drive member mechanism defining a primary parallel axis 256. The housings for the moving ribbon portion and the drive member mechanism component portion are different housing configurations. may have the following structure:

[0295] Both of these devices, as well as the devices shown in Figures 55-132, contain a drug. DELIVERY DEVICE FOR USE WITH A CONTAINER HAVING A CONTAINER BODY CURED WITH A LOW TEMPERATURE AND DEFINING AN OUTLET - Patent application The container includes a piston disposed within the container body, and a piston in front of the container body. The delivery device is adapted to couple to the container and releases the drug through the outlet. a housing; a piston coupled to the housing and adapted to advance the piston within the container; and a drive assembly having a distal edge portion and a proximal edge portion. The drive ribbon has a stored configuration and an extended configuration, and the drive ribbon in the stored configuration The retracted portion of the ribbon defines a spiral, and the extended portion of the drive ribbon in the extended configuration The interdigitated portions define a helix. The drive ribbons are progressively movable from a retracted configuration to an extended configuration. The movement of the drive ribbon from the retracted configuration to the extended configuration defines a drive axis and is coupled to the container body. The drive member mechanism is operatively coupled to the drive ribbon and has a drive shaft and The drive member mechanism generates a force that is transmitted to the drive ribbon to drive the drive member. Move the ribbon from a retracted configuration to an expanded configuration.

[0296] Several embodiments of such a two-axis device are now described. The form is shown in several figures, such as those shown in Figures 55-78 and 97-114. The example shown has a drive member mechanism including a spring S aligned with a secondary shaft. The dosage is set by tensioning and releasing the tension from the spring S. , generating a force transmitted to the drive ribbon R to move the drive ribbon from the retracted configuration to the extended configuration. This includes:

[0297] Some of the illustrated dual axis embodiments, such as those shown in Figures 79-96, The drive member mechanism includes a plunger disposed along a primary axis, and the linear movement of the plunger is , a force is transmitted to the drive ribbon R to move the drive ribbon from the retracted configuration to the extended configuration Generate.

[0298] Still other illustrated dual axis embodiments, such as those shown in Figs. 115-132, a drive member mechanism including an electric motor M drivingly connected to an element arranged along a secondary axis The electric motor M generates a force that is transmitted to the drive ribbon R to move the drive ribbon through the storage structure. In such an embodiment, the element disposed along the secondary axis is moved from the extended configuration to the expanded configuration. may be the drive shaft of an electric motor.

[0299] In some of the illustrated embodiments, such as those of FIGS. 55-102, the drive ribbon R and the drive member mechanism is disposed within the housing, and the container 248 is removable from the housing. Therefore, these devices are either single-use or disposable pre-filled. However, modifications of such devices may be made to accommodate multiple use applications. Alternatively, the device may be any of the devices shown in Figures 103-136. It may have any more modular architecture.

[0300] Now referring to the device designated as device 253'' shown in Figures 55-60. The device then includes a primary axis 254 and a secondary axis 256. The dial knob of the secondary axis DK is a ratchet mechanism (dial ratchet) that rotates the sleeve SL and the torsion spring S. Used by the DR to set the dosage and tension of the torsion spring S The sleeve SL is coupled with the injection button B, and when the injection button is pressed, the sleeve , shift and release the spring. When the spring S is released, it shifts the output ratchet O into position. The output ratchet O then rotates the drive ribbon R. The output ratchet O engages the drive member, which in turn drives the ribbon, or non-rotating ribbon. If a bonnet is used, it engages and rotates a thrust member such as those previously described. Rotation of the ribbon or thrust member causes the ribbon to expand axially, thereby moving the piston. The threaded member IRD is used to measure the residual dose of the drug from the cartridge. It acts as an indicator and controls the rotation of the sleeve SL and thus the drug in the 3 ml cartridge. The diameter of the part IRD, which is the dimension corresponding to the amount of the thread of the sleeve SL, is moved along the length of the thread of the sleeve SL. The "Revolution Count IRD" prevents the rotation of the rotary knob DK. Figure 59 shows the dial configuration and A dial knob DK is used to set the dosage by tensioning the torsion spring S, also called The device 253'' is shown as it is being rotated. Rotation of the dial knob DK results in the following: Additionally, a dosage indicator is visible through a window W defined by the housing. Rotating the dial 259 provides an indication of the dialed amount. The injection hand after the button is pressed by the user to release the spring S which rotates the 258 Illustrated is device 253'' in sequence.

[0301] The device 253A'' shown in FIGS. 61-66 is similar to that shown in FIGS. 55-60. Similarly, the dial knob DK of the embodiment of FIGS. 61-66 has an injector instead of a distal end. A button B is located at the proximal end of the device. Rotation of the dial knob DK causes the dial The ratchet 261 rotates the inner sleeve SL. FIG. 65 shows how to set the dose. FIG. 66 shows the device 253A'' arranged in a dial configuration for 2 shows the device 253A'' during an injection procedure after the has been pressed by a user.

[0302] The device 253''' shown in FIGS. 67-72 includes a drive ribbon defining a main axis 254. R and a drive mechanism about a secondary axis 256. The drive member mechanism is The dial knob DK is rotated by the user to The dial ratchet 261 rotates the inner sleeve SL. When rotated, it tensions the torsion spring S. When the injection button B is pressed, the three 3. This moves the shift member 260 which shifts the spring, thereby releasing the torsion spring. When the torsion spring is released, it rotates the output sleeve 262. 262 drives the ribbon assembly when the output sleeve 262 is rotated, and The input sleeve has an output ratchet O disposed on the input sleeve. The catheter includes a threaded portion in which the catheter (dose) is placed.

[0303] The device 253'''' shown in FIGS. 73-78 may also be used to distribute the drug during the injection procedure. 67-72. The embodiment of Figures 73-78 is configured differently to set the dose. The dial knob DK is used to rotate the dial ratchet. The sleeve SL is rotated by the torsion bar 261. When the sleeve SL is rotated, it The shift member 264 also defines an injection button B. The material 264 is moved from the dial dose set position shown in FIG. 77 to the injection dose delivery position shown in FIG. When it is moved to the reaching position, it releases the torsion spring S. The spring S rotates the output sleeve 266. Then, the output latch on the output sleeve 266 The jet member O drives the ribbon assembly to expand the drive ribbon R and advance the piston. The threaded component IRD (Insufficient Dose) is rotated by a dial knob. The threaded portion of the sleeve is placed on the threaded portion of the sleeve.

[0304] The embodiment shown in Figures 55-78 has an injection button located at one of the ends of the device. And with the limited exception of when a button is pressed to activate the injection sequence, the setting of the dose No change in length occurs during timing or drive ribbon expansion, and the movement of the injection button is slight in length In contrast, the devices shown in Figures 79-96 and described further below The device extends when the dose is set, and the plunger is then manually depressed. When the drive ribbon is released back into its original position, it expands and advances the piston through the drug reservoir, dispensing the drug. It includes a plunger that increases the length of the device, providing the driving force for dispensing.

[0305] The device 263 shown in Figs. 79-84 includes a dial knob D for setting the dose. When the dial knob DK is rotated, a dial in the form of a one-way ratchet mechanism 261 is rotated. The yoke clicker rotates the sleeve SL. When the sleeve SL rotates, the plunger PL extends proximally from the housing due to the threaded engagement of the sleeve and plunger. This places the device in a dial dose setting configuration as shown in FIG. The device is retracted when the jar PL is manually depressed to push it distally back into the housing. The sleeve SL is rotated in the opposite direction to the injection dose delivery configuration shown in FIG. The plunger PL is extended and rotates the output sleeve 268. Or it will not rotate even if it is pressed down. To prevent the plunger PL from rotating, The stem of the plunger has a non-circular cross section that passes through a corresponding opening in the housing. Then, the output ratchet O on the output sleeve transmits the rotational force to the drive member. Rotating either the drive ribbon R or the thrust member advances the piston axially. The drug is released.

[0306] The device 263' shown in Figures 85-90 is generally similar to that shown in Figures 79-84. The dial knob DK is similar to that of the casing, but is relocated to the proximal end of the housing. Each of these embodiments also includes a threaded member IR disposed in the threaded portion of the sleeve. D (residual dose) may be included.

[0307] The device 263'' shown in FIGS. 91-96 has an expandable plunger and a secondary Several components of the drive assembly around the axis 256 are dosed It expands with the plunger when it is being pressed down and moves with the plunger when it is being pressed down. The dial knob is used to set the dosage. Rotating the dial knob DK This rotates the dial sleeve 270 and the plunger rod 274. The head 274 is threaded and engages with a threaded opening 276 located on the interior of the housing. Rotation of the plunger rod 274 relative to the opening 276 is as shown in FIG. Then, when setting a dosage, the plunger rod 274 is extended proximally from the housing. At the same time, the sleeve 270 is rotatably separated from the plunger rod 274. The sleeve 278 and plunger rod 278 are dialed in to move axially. Pressing button B causes the plunger rod 274 to rotatably engage the output sleeve 272. The dial assembly is rotatably engaged with the sleeve 270. The dial assembly is pushed distally into the housing. When it is rotated back, it rotates, causing the output sleeve 272 to also rotate, as shown in FIG. When the output sleeve 272 rotates, the output ratchet O on the output sleeve 272 The output shaft then rotates a drive or thrust member. This expands the drive ribbon R, moving the piston forward and expelling the drug.

[0308] Modular Architecture The device 283 shown in Figures 97-102 includes a drug container, a drive ribbon and a drive assembly. The cartridge unit has an injection button that can be attached to the cartridge unit. It has a modular architecture with removable electronic modules. The module can be reused multiple times with different cartridge units having the same basic structure. Such a cartridge unit may also be a disposable unit. good.

[0309] The device shown in Figures 97-102 is removable from the cartridge unit 282. The cartridge unit has a reusable electronic module 280 that can be connected to The unit 282 includes a drug container 248 that holds a drug and has a piston. Advancement dispenses the medication through the injection needle 252. The drive ribbon R advances the piston and defines the main drive shaft 254. The illustrated cartridge unit 282 also , including a drive member mechanism about a secondary axis 256. 2 is a disposable cartridge that is disposed of after depletion of the drug.

[0310] A dial knob DK is used to set the dosage. Rotation of the dial knob DK The sleeve SL is rotated by the dial ratchet 261. The rotation of the sleeve SL is Apply tension to the torsion spring S. Move the injection button B from the position shown in Figure 101 to the position shown in Figure 102. When moved to the position shown in FIG. 1, arm 285 of button B engages sleeve SL, Allows sleeve SL to shift axially, thereby releasing torsion spring S If the display is removed, injection cannot be started. The torsion spring S rotates the output sleeve 284. The rotation of the output sleeve 284 is , is transmitted to the ribbon assembly, expanding the drive ribbon R, thereby advancing the piston. When the injection button B is in the position shown in FIG. prevents the transmission of torque from the torsion spring S to the output sleeve 284, thereby The spring S is in an axial position that prevents the drive ribbon R from advancing. When the cartridge unit 280 is removed from the cartridge unit 282, the sleeve S is The torsion spring S therefore remains in the position where it is when the electronic module 280 is removed. When this occurs, the drive ribbon R is not advanced.

[0311] The embodiment of Figures 103-136 also has a modular architecture. However, the reusable modules of these embodiments are not limited to the secondary axis drive member mechanism. This includes a structure that allows a larger percentage of the overall assembly to be reused. The drive member mechanism is disposed within the housing, and the device further comprises a cart. a cartridge housing including a drive ribbon disposed within the cartridge housing, the container including a The cartridge housing is attached to the housing. It can be releasably fixed.

[0312] In the embodiment shown in Figures 103-108 and 109-114, the device A drive member mechanism including a spring aligned with the secondary axis, and setting the dose is achieved by tensioning the spring. and releasing tension from the springs to move the drive ribbons from the retracted configuration to the extended configuration. and generating a force that is transmitted to the drive ribbon.

[0313] More specifically, the device 293 shown in Figs. 103-108 includes a cartridge a housing 286A and a reusable module 288 having a main housing 288A; As can be seen in FIG. 103, the drive ribbon R is A cartridge 148 for holding the drug is disposed within the cartridge housing 286A. As can be seen in FIG. 103, the drive ribbon R A drive member mechanism 290 for driving the axial advancement of the secondary Centered on axis 256.

[0314] The illustrated device 293 includes a dial knob DK that is used to set the dose. The rotation of the dial knob DK rotates the sleeve SL by the dial ratchet 261. When the sleeve SL rotates, tension is applied to the torsion spring S. Injection button B When pressed, the sleeve SL is shifted and the torsion spring S is released. The torsion spring S rotates the output member 292, which in turn engages the drive ribbon R. The dial 29 rotates the connected drive member 294, thereby expanding the drive ribbon. 7 is provided between the sleeve SL and the spring S and is an interlock for tracking the dosage. Used in conjunction with Q295.

[0315] The reusable module 288 is an electronics module (not shown) coupled to a display. The interlock 295 is configured to lock the reusable module 288 into the cassette 286. Provides an electrical signal that the electronic module uses to determine whether The sensor detects the rotational movement of the sleeve SL and detects the rotation of the dial knob DK. The electronic module then transmits data regarding the amount of drug dispensed based on the degree to which the sleeve has rotated. The interlock is provided to the controller by resetting the position of dial 297. The device can be configured to return to zero when the cassette is removed. Set 286 includes an RFID (radio frequency identification) chip for identifying the contents of the drug container. Advantageously, the RFID chip is readable and writable, thereby The electronics module on the reusable module 288 reprograms the cassette 286 after each injection procedure. The module can record data relating to the amount of medication dispensed from the The cassette 286 may be configured to determine the amount of medication remaining in the cassette. Read-only RF with other forms of digital memory for recording such data The cassette may have an ID tag. Data regarding the type and remaining amount of the drug may be recorded on the cassette. Therefore, the cassette 286 can be removed from the reusable module 288 before it is completely depleted. The cassette can then be reinserted and the drug and remaining amount can be recorded. the electronic module that can read data relating to the identity of the This is because the electronic module accurately tracks the amount of medication remaining and ensures that the cassette is partially If the IRD (insufficient residual value) is removed empty and then reinstalled, dosage) message.

[0316] The device 293'' shown in Figs. 109-114 may be the same as that shown in Figs. 103-108. 298, which is similar to, but different from, the reusable module 298, The dial knob DK is disposed at the distal end of the control 298 instead of at the proximal end. The DK is used to set the dose, and the rotation of the knob dials the ratchet 261 The rotation of the sleeve SL applies tension to the torsion spring S. Depressing the injection button B releases the spring S, which in turn rotates the output member 296. Rotation of the output member 296 drives the extension of the drive ribbon R. Similar to module 288. Additionally, a module 298 is coupled to the display and communicates with the cassette to display the contents of the cassette. The battery includes an electronic module capable of identifying the battery capacity and remaining capacity.

[0317] Instead of having a spring driven member mechanism, the reusable module may instead use an electric motor. For example, Figures 115-120; Figures 121-126; and Figures 127- The embodiment shown in FIG. 132 is each drivingly connected to an element disposed along a secondary axis. The electric motor has a drive member mechanism that transmits power to the drive ribbon. For example, the motor shaft is , may be elements disposed along and defining the secondary axis.

[0318] The device 303 shown in FIGS. 115-120 can be coupled to the cassette 286. The reusable module 300 includes an electric motor M that can be used to drive the The motor shaft 304 rotates the element 302, which in turn drives the drive member 294 of the cassette. Rotate to expand the drive ribbon R. In Figures 115-120, the drive ribbon R is rotated. Cassette housing member 287 functions as a rotational restraining member. axially extending tabs (not shown) serve to prevent rotation of the drive ribbon R. The drive member 294 functions as a thrust member and engages the drive ribbon R. The drive member 294 includes a helical screw that drives the drive member 294 in an axial direction. 294 in an annular groove that allows for axial movement of the drive member 294 but prevents axial movement of the drive member 294. 7. The outer radial surface of the drive member 294 is axially captured by the The drive element projects outwardly from the cassette and defines a geared surface such that the drive element can 302 has a cooperating geared surface for engaging and rotatably driving the drive member 294. To define.

[0319] An electronic module is used to control the operation of the motor. Dial Knob DK is used to generate a signal to the electronic module to define the dose, and the injection button The motor B communicates with the electronic module to start the motor operation. As can be seen in Figure 116. , the dial knob DK is located at the distal end of the module 300, while the injection button B is , the module furthest from the cartridge 248 of the cassette 286 and close to the dial knob DK The electronic module is also located on the side of the cassette 286 as described above. to identify the contents of the cartridge 248 and determine the amount of medication remaining in the cassette. It can be determined.

[0320] The device 303' shown in Figures 121-126 has a cassette 286 attached thereto. The module 306 includes an electric motor. M and has the same general functionality as module 300. The motor shaft 308 Extending from the rotor M is a drive element 310 attached to the shaft 308. The element 310 engages and rotates with the drive member 294 on the cassette 286 when the motor M is energized. Module 306 differs from module 300 in that it includes a proximal leg 312. The legs 312 are disposed adjacent the proximal end of the cassette 286 and are attached thereon. The cassette 286 has an injection button B. The legs 312 help prevent accidental removal of the cassette 286. It also provides a more secure attachment to the cassette 286. The ribbon may be positioned on a drive shaft 254. This arrangement is more convenient because it resembles a syringe with an in-line manual plunger. It feels intuitive and comfortable.

[0321] The device 303 ″ shown in FIG. 127-FIG. 132 is similar to the module 306 . The reusable module 314 has the only difference being that the module 314 is a dial knob. The advantage of this is that you can set the dose using the input button 316 instead of the As shown, one of the input buttons 316 is for increasing the dose, and the other is for The other of the buttons 316 is for decreasing the dosage. It can be used to indicate a change in dosage as a result of use of the force button.

[0322] The reusable motors described herein having electric motors M and / or electronic modules In both modules, the reusable modules consist of an electric motor and an electronic module. A single rechargeable disposable battery for powering the board and / or cassette 286' or may include a rechargeable battery (shown in FIG. 127 as battery 313). The electronic module (s) described herein in electrical communication with the module and cassette. The electronic module 315 shown in FIG. 127 is a module and a cassette. and configured to control the operation of the and a transceiver or alternative communications hardware.

[0323] Instead of rechargeable batteries, the reusable modules described herein use disposable It can be battery powered or requires electrical power to empty the contents of the cassette. Instead of mounting it on a module of a size that provides enough energy for the motor M, A disposable battery may also be included in each cassette. In this regard, FIG. Cassette 2 has a battery 317 for powering the reusable module. Note that the battery or other power source is shown diagrammatically in cassette 286'. When placed in the cassette, electrical contacts 319 and module electrical contacts 321 (FIG. 132) , when the cassette and module are connected, they engage, thereby removing the module from the cassette Any of the cassettes and reusable modules described herein may be used. Such cooperating electrical contacts in the reusable module may also be connected to the electronic circuitry on the cassette. The NI PXIe-4110 may be used to provide communication or power conduits between the NI PXIe-4110 and the module.

[0324] As best understood with reference to Figures 133-136, reusable modules and and a cassette having a cartridge housing, the device further comprises: The cartridge may include a plurality of cartridges, each cartridge being provided with a cartridge housing. a cartridge housing having a drive ribbon disposed therein; and a receptacle mounted on the cartridge, each cartridge being a reusable modular housing. The housing is replaceably and removably securable to the housing.

[0325] Additionally, as discussed above with respect to a single cassette, those having multiple cartridges may In one embodiment, the electronic module is disposed on the housing of the reusable module. Each of the multiple cartridges can also be read / write RFID or other forms of digital memory (e.g., internal flash memory or on-board EE It can contain digital memory devices such as PROMs. The electronic module includes a digital memory device and a cartridge coupled to the housing. After establishing communication with the electronic module and completing the injection procedure, the electronic module stores data related to the injection procedure. In such an embodiment, the digital memory device The data recorded on the device may include data relating to the volume of medication remaining in the container. In such an embodiment, the multiple cartridges may all contain the same medication. , or they may contain a number of different drugs.

[0326] FIG. 133 shows a cassette 286, a second cassette 318, and a removable cassette 318 for the cassette 286. FIG. 3 shows a drug delivery system 317 including a reusable module 319 that can be removably secured. , whereby the module 319 drives the extension of the drive ribbon in the cassette 286 The second cassette 318 can dispense the drug. It may be identical to cassette 286, except that it does not further include a needle assembly. Ability to replace cassettes 286 and 318 with a single reusable module 316 This has several advantages, for example, it reduces the need for patients to inject two different drugs during the same day. Cassettes 286 and 318 may be configured to hold two different drugs, The patient can be fitted with two different cassettes providing a compact system. In addition, the cassette 2 is only required to carry a single module 316. The 86 and 318 are Read / Write RFID or Read-Only RFID and Decode The cassette may be equipped with a digital memory so that the patient can easily replace the cassette as needed. The module can be used to administer the drug contained in the attached cassette as described above. Alternatively, the patient may be able to identify a single medication and the amount remaining in the cassette. Even if only one cassette is needed, they will be used in module 316 and when the first cassette is exhausted. The second cassette provides a backup if one is damaged or needs to be replaced for other reasons. The patient is then provided with two cassettes 286 and 318, each of which holds the same drug and serves as a supply of It may be useful to

[0327] FIG. 134 also illustrates that the module 316 may be configured to receive multiple copies of different drugs within the drug delivery system 331. FIG. 134 shows how the embodiment of FIG. 134 can be used with the cassette of FIG. In configuration, cassettes 320 and 322 all have the same structure as cassette 318. The only difference between sets 320 and 322 is that cassette 322 contains a different drug than cassette 320. The RFID on the cassette identifies the medication contained within the cassette. Such information may be displayed on the display of module 319 where the user can reuse it. The cassettes holding different drugs can also be displayed as shown. Also, they are advantageously identifiable by visual inspection. For example, cassettes all holding the same type of medication may be The set 320 can advantageously have cartridge housings of the same color while having different The cassettes 322 holding different medications have cartridge housings of different colors. A printed label may also be affixed to the cassette identifying the contents of the set.

[0328] In the embodiment of Figures 133-134, the cassettes 286, 318, 320, 322 are Each contains data on the type of medication contained in the cartridge and the amount of medication remaining. The device may have a digital memory device 323 that includes a serial number, date of manufacture, and other information. Additionally, other data may be stored in the digital memory device 323. The 319 is an electronic module that utilizes a controller to control the operation of the modules and cassettes. The electronic module 329 also includes a cassette 329 engaged with the module 316. The digital memory device 323 communicates with the device to record the type of drug in the cassette and the remaining amount of drug. Get information about the quantity.

[0329] Also shown in Figs. 133-134 are cassettes 286, 318, 320, 3 22 and cooperating electrical contacts 327 on module 316. When the set is attached to the module 316, the cooperating contacts 325, 327 are engaged to provide electrical communication therebetween for signal transmission and / or power. By using contacts 325, 327, the electronic module 316 29 to communicate with the digital memory device 323 in a hardwired manner. Alternatively, the electronic module 329 may communicate wirelessly with the digital memory device 323. The contacts 325, 327 indicate that the cassette has been successfully docked into the module 316. For example, contacts 325 and 327 may be used to verify that the When disengaged, the circuit on the module 316 with the contacts 325 may be open. Then, when the cassette is installed in the module 316, the contact 327 contacts the contact 325. 325 and closes the circuit in which the contact 325 is located. 25 is monitored for open or closed status, thereby determining whether the cassette is in a modulated state. It can be determined whether the sensor is attached to module 316.

[0330] 135 and 136 are diagrams showing the systems 317 and 318 of FIG. 133 and FIG. 134, respectively. 31, except that module 324 includes legs 312 of similar module 306. System 33 has a reusable module 324 that differs from module 316 in that 3, 335. Otherwise, the reusable module 324 is It functions the same as module 316 and is connected to the cassette in the same manner as described above for module 316. can be used with ports 286, 318 and 320 and 322.

[0331] Reusable modules and cassettes allow you to track the amount of medication remaining in the cassette in a variety of ways. As mentioned above, the remaining amount can be tracked based on the set dose and and / or monitor the mechanical output delivered to the cassette to determine the amount of drug dispensed during each infusion procedure. This can be tracked by having a reusable module that determines the amount of The original amount of drug held in the drug container is known and therefore the amount dispensed cannot be subtracted. By pulling, the remaining amount can be tracked and monitored.

[0332] Alternatively, the degree to which the drive ribbons are axially expanded can be monitored to determine the remaining amount. For example, the drive ribbon can have markings that can be read by an optical sensor. The optical sensor detects markings on the extended portion of the drive ribbon. In the case of devices with modular architecture, the optical sensors are driven by A cassette or a cassette housing having a window through which an extended portion of the moving ribbon can be viewed. The sensors can be placed in a reusable module. It can count overruns or recognize separate markings to tell you when the drive ribbon is on the shaft. The extent to which the drive ribbons are expanded in the axial direction can be determined. By tracking the size of the drug container, the amount of drug remaining can be determined. In this regard, the drive ribbon may be adapted to initially engage the piston without administering the drug. It may be necessary to first determine the length to which the first contact point is reached. The expansion of the drive ribbon after the drive ribbon is driven is similar to that of a conventional drug container having known dimensions. can be easily converted to a quantity of

[0333] FIG. 137-FIG. 145 show a reusable drive member mechanism module and a cartridge housing. FIG. 146- shows an example of a cassette having a drive ribbon and a drive ring disposed therein. FIG. 211 also illustrates an example of a reusable drive member mechanism module and cassette. One difference between the embodiment of Figures 137-145 and the embodiment of Figures 146-211 is 137-145, the size of the electric motor and the motor shaft are The size of the installed gear is larger than that of the embodiment of Figures 137-145. Where parts of the two embodiments are the same and function in the same way, the same reference numbers are used. The numbers are used in each embodiment.

[0334] The device 326 shown in Figs. 137-145 includes a reusable module 328 and The needle assembly 332 includes a threaded retaining member for a drug container 334. The module 328 has an electric motor 338 mounted therein. The motor 338 includes a housing 336 that receives the rotation of the motor 338. The gear 340 is coupled to the output shaft of the motor 338. A portion of the gear 340 protrudes outward from the housing 336. , so that when cassette 330 is attached to module 328, cassette 3 30. The gear member 342 in the gear unit 340 may be engaged with the gear member 342 in the gear unit 30.

[0335] Cassette 330 includes a housing 344 that defines a projection 346 having a T-shaped cross-section. The module housing 336 has corresponding T-shaped slots 348 that receive the protrusions 346. The cassette 330 also defines a second T-slot 352 on the housing 336. The second T-shaped projection 350 is received by the second T-shaped projection 350. The T-shaped projection is received in the T-shaped slot. When the module 328 slides into the cassette, a spring biases the latch member 354 on the module 328 to pivot. The button 356 engages a protruding lip on the cassette to prevent the cassette from slipping out of engagement. is depressed to disengage the latch member 354.

[0336] The device 360 ​​is shown in Figs. 146-211 and includes a reusable module 36 2 and a cassette 330. The cassette 330 is secured to the module 328. In the same manner, the module 362 is removably secured to the module 362. A thinner electric motor 364 and a thinner It has a smaller output gear 367 but is otherwise of the same construction.

[0337] FIG. 164 provides an exploded view of the cassette 330. The cassette 330 is an integral cartridge. The drive ribbon 3 includes a base member 366 and a retaining member 368 that define a housing. 70 is disposed within the cartridge housing and includes a thrust member 372, a ring 374 and The drive ribbon 370 is supported by a bearing member 378. The movable ribbon 370 is secured to a distal end thereof and engages a piston 380 within the drug reservoir 334. The ribbon 370 expands without rotating, and the bearing members 378 are fixed directly to the ribbon 370. The original 3 ml drug container 334 is held within a holding member 368. The holding member 368 has a The material 368 has a bayonet type engagement for attaching the material 368 to the cassette, but is not limited to a permanent adhesive. Other suitable means, such as, may alternatively be used.

[0338] The cassette base 366 is shown in Figures 165-170. The gear member 367 is a gear formed on the thrust member 372. The base 366 also includes a window 382 that allows the base 366 to mate with the T-shaped projection 342. 46 and a pair of smaller protrusions 384, 386. Protrusions 384 are 30 is engaged by latch 354 when engaging with the reusable module, and protrusion 3 86 prevents inadvertent external disengagement of latch 354 .

[0339] A cassette collar 376 is shown in Figures 171-176. Collar 376 has a central circle The central opening 388 defines a barrel opening 388. Within the central opening 388 are a plurality of axially extending ribs 390. As will be described further below, the ribs 390 act as a guide for the expansion of the drive ribbon 370. 370. The tensioned portion of the drive ribbon 370 is engaged with an axially extending groove 371 to prevent rotation of the tensioned portion. The collar 376 fits within the base member 366 so that the collar 376 is The first portion 392 has a non-circular cross-section that prevents the first portion 392 from rotating relative to the base 366. The ribs 390 thereby support the extended portion of the drive ribbon 370 against the base 366. The second portion 394 is disposed distally of the end of the base 366. , which receives the bayonet protrusion of the holder 368, thereby connecting the holder 368 to the cassette 330. Part 394 has two bayonet fittings that fit between the bayonet fittings of holder 368. The collar 376 also extends proximally and has a central cylindrical opening with a protrusion 395. The cylindrical portion 396 also includes a cylindrical projection 396 that defines a portion of the central bore 388. An annular recess 397 is defined in the outer surface.

[0340] The cassette ring 374 is shown in Figures 177-181. The ring 374 has a cylindrical portion 396 and properly positions the collar 376 relative to the thrust member 372 . The ring 374 also includes a rotatable thrust member 372 and a rotationally fixed collar 373. 76. The annular projection 373 of the ring 374 is in contact with the annular projection 396. The threaded portion 375 of the ring 374 fits within the recess 397 and thrusts the ring 374. The ring 374 is secured to the member 372 such that the ring 374 is in thrust relative to the collar 376. 372 and the attached ring 374 while still allowing rotation. Axial separation of collar 376 from member 372 is prevented.

[0341] Distal support member 378 is shown in FIGS. 182-186. Member 378 supports piston 3 80 and a distal bearing flange 398 that is radially inwardly spaced from the distal most portion of the drive ribbon 370. and a mounting stem 400 disposed on the inner side of the mounting post 400. 02 engages with holes on the drive ribbon 370 to attach the bearing members 378 to the drive ribbon 370. wear.

[0342] The thrust member 372 is shown in Figures 187-192. In another embodiment, the gear component is a thrust member. Gear 342 engages gear 367, which drives motor 364. When the gear 367 is energized to rotate, the thrust member 372 rotates. 372 has a generally cylindrical shape and rotates within and relative to base 366. The proximal end of the thrust member 372 provides a storage space for the retracted portion of the drive ribbon 370. The distal end of the thrust member 372 is formed with a cylindrical skirt 404 which acts as a bobbin. The screw 406 engages the ring 374 with the screw 375 to urge the ring 374 toward the thrust member 37. 2. As mentioned above, this also secures the thrust member 372 to the collar 376. and the collar 376 is moved toward the thrust member 37 while still allowing the ring 374 to rotate. Fix axially to 2.

[0343] An 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 helical threads 412 that act as cam ramps. The screw 412 is threaded through the drive ribbon 370 which extends helically through the expanded portion of the drive ribbon 370. 70. When cassette 330 is first assembled, drive ribbon 370 A portion of the thrust member 372 is placed in an expanded configuration, with the threads 412 engaging the grooves 369. Upon subsequent rotation, the screw 412 urges the ribbon 470 from the retracted configuration to the extended configuration, This either extends the axial length of the expanded configuration or, depending on the direction of rotation, rotates the ribbon from the extended configuration to the retracted configuration, thereby reducing the axial displacement of the extended portion of the drive ribbon. Reduced length. Module 328 designed to work only with disposable cassettes 330 If so, the drive ribbon 370 must be retracted after the contents of the container 334 have been emptied. Instead, the module 328 rotates the shaft of the drive ribbon 370 when the motor 364 is energized. It can be configured to rotate in only one direction, which is the direction corresponding to the directional expansion. When screw 412 engages spiral groove 369 to move drive ribbon 370 axially, collar 376 Ribs 390 disposed on the ribbon 370 engage axially extending grooves 371 on the ribbon 370, Note that this prevents rotation of the ribbon 370. As the ribbon moves to the collar 372, Adjacent edges of ribbon 370 also become engaged with one another.

[0344] The retaining member 368 is shown in Figures 193-198. The retaining member 368 is reusable. The retaining member 368 also defines a T-shaped projection 350 for engaging a corresponding module. 395. The nozzle 376 is inserted into a bore defined by a portion 394 of the nozzle 376 and fits snugly between the projections 395. A pair of bayonet attachments which mate together, thereby attaching the retaining member 368 to the cassette 330. The retaining member 36 may include an adhesive 414. Alternative attachment means, such as a permanent adhesive, may be used to attach the retaining member 36. 8 can be attached to the cassette 330. The drug container 334 can be attached to the cassette 330 by attaching the retaining member 368 to the cassette. Before being attached to the set 330, the retaining member 368 is placed in the holder 368. The proximal end 416 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 is inserted into the drug container 3 The septum on 34 is punctured, thereby allowing the drug to be dispensed through the needle. The cutout at 368 forms a window 418 through which the user can see the medication container 334. This allows the amount of drug remaining in the container to be determined by visual inspection.

[0345] The drive ribbon 370 is shown in Figs. 199-211. Moving ribbon 370 is shown in the configuration it assumes within cassette 330. In this configuration, The expanded portion 420 of the ribbon 370 defines a helix, while the lattice of the ribbon 370 The recessed portion 422 defines a spiral. As can be seen in Figs. The distal portion of ribbon 370 defines a pair of holes 401 that receive posts 402 therein. The outer surface of the ribbon 370 is formed with a rib 372 therebetween. The protrusions 424 and 424 define grooves 369, 371. The grooves 369, 371 are formed in the retracted portion of the ribbon 370 as well as in the expanded portion 420. 422, but Figs. 199-201 are for graphic simplification and clarity. Note that for purposes of illustration, the protrusions 424 or grooves 369, 371 are not shown.

[0346] The individual features of the drive ribbon 370 are shown in FIG. This can be seen best in Figs. 203-207, which show the 70. Fig. 203 and detailed view Fig. 2 06 shows the outward facing surface of the drive ribbon 370, while FIG. 205 and detailed view FIG. 207 FIG. 203 shows the inward facing surface of the drive ribbon 370. FIG. 204 shows the edge of the ribbon 370. is.

[0347] As best seen in FIG. 206, protrusions on the radially outward surface of ribbon 370 The protrusions 424 define two sets of parallel grooves 369, 371 between the protrusions 424. The grooves 369 are The groove 369 extends in a spiral shape on the expanded portion 420 of the ribbon 370. 372, forming the drive ribbon 370 into a helical shape. The engagement of 412 with groove 369 also prevents axially directed forces from moving between ribbon 370 and thrust member 370. The groove 371 allows the ribbon 370 to communicate with the expanded portion 372. 420 and engages with rib 390 on collar 376 as described above. , preventing rotation of the expanded portion 420.

[0348] As best seen in FIG. 207, an edge of ribbon 370 (shown as distal edge 426) One of the edges (shown as proximal edge 428) defines a plurality of projections 432. 207.) The other edge defines a corresponding number of openings 430. As can be seen in FIG. 432 and protrusion 424 overlap along distal edge 426. When the distal end 426 and the proximal edge 428 are engaged, the proximal edge 428 extends radially outwardly from the distal end 426. When the distal edge 426 moves radially inward to engage the proximal edge 428, The opening 430 and the protrusion 432 interlock to connect the two edges, and the overlapping protrusion 424 The protrusion 432 prevents the protrusion 432 from being pushed completely through the opening 430. 0 provides shear resistance along the edge and the shape of the protrusion 432 with the opening 430. However, the projection 432 has an enlarged head with a narrow neck, which resists axial separation of the two connecting edges. I also do that.

[0349] When using a drive ribbon 370, only a single ribbon 370 is used with each cassette 330. is used, and the distal and proximal edges of each ribbon are aligned in the expanded portion of the ribbon. In Figs. 208-211, two ribbons 370 are connected to the body at their distal and The endothelial ligament is shown lying flat with the proximal and distal edges connected, clearly showing the connection of the two edges and the diagram. In use, the two separate drive ribbons 370 are shown in FIG. As shown in Figure 211, they are not joined together (to form a single large ribbon). (It is possible to exclude this.)

[0350] Figures 212-216 show the control and precision of individual doses delivered by the device. Several additional embodiments are shown that use different types of control to improve performance.

[0351] FIG. 212 illustrates a method for using an encoder to record a signal by a device such as the device of FIG. 1 illustrates, in schematic form, an embodiment that provides improved control and precision of the delivered dose. In an embodiment, the rotational drive ribbon 440 includes a set of gear teeth 442 along its proximal edge. The electric motor 444 drives a gear 446, which in turn engages the gear teeth 442, thereby 4, which drives the rotation of the drive ribbon 440. The drive ribbon 440 is also detected by the optical sensor 450. 4, a series of encoder targets 452, such as dark rectangles, that can be distinguished from the drive ribbon 440. The optical sensor 450 generates a signal that is received by the processor 448. Processor 4 counts the number of encoder targets that pass through the 48 indicates drive ribbon parameters such as the axially extended length of the drive ribbon 440 ( (e.g., angular position, length or extension position, speed of extension and / or retraction, stopping) The processor 448 can use this information to control the operation of the motor 444. The device controls the amount of the drug delivered, thereby controlling the dosage delivered by the device.

[0352] Figures 213 and 214 show the use of mechanical controls to improve dose control and accuracy. The device used is shown diagrammatically in Fig. 213-214. The embodiment of Fig. 213-214 shows a pretension spring. The drive ribbon 454 is driven by a spring 458. The spring 458 is attached to the drive ribbon 454 during manufacture. The drive ribbon 454 has enough pretension to fully extend and rotate. 54 also includes a series of projections 456 that project radially outward from ribbon 454. The distance between each of the 456 is a given amount of the drug, such as an individual dose or a percentage of the whole. Corresponds to dosage.

[0353] The actuator 460 is mounted in a housing 462 and includes a cam surface 464. As the actuator 460 is depressed radially inward, the cam surface 464 engages the control member 46 6. The control member 466 is disposed adjacent to the expanded portion of the drive ribbon 454. 213 and 214 by a spring (not shown) or other biasing member. In this position, it blocks the passage of the projection 456. 6 also defines a cam surface 468 that is engageable with cam surface 464 on actuator 460. This includes teeth that

[0354] When actuator 460 is depressed, cam surfaces 464 and 468 interact to , biasing the control member 466 upward so that the opening 470 is This allows the protrusion 456 to pass through the opening 470. 458, allowing the drive ribbon 454 to expand under the influence of the pretension spring 458. The actuator 460 also includes a spring biasing it out of engagement with the control member 466. (not shown). Thus, when actuator 460 is depressed and released , moving the control member 466 to a position where the protrusion 456 can pass through the opening 470; The control member 466 is then returned to a position that blocks the passage of the projection 456. This is done by the user The dispenser 460 can be easily used to dispense a predetermined dose by depressing and releasing the dispenser 460. To perform.

[0355] FIG. 215 illustrates an image sensor for reading a code 474 on a rotating drive ribbon 472. The device shown utilizes a code 474 that is attached to a drive ribbon 472. spaced apart and imaged by an image sensor 476 to facilitate control of individual dose delivery. The signals generated by the image sensor 476 are communicated to a processor 478. The image sensor 478 then reads the image data from the image sensor 476 and stores the image data in a digital memory. 476 to rotate the drive ribbon 472 based on the signal generated by the The code 474 may take a variety of forms, including: For example, they can be QR codes, bar codes, encoder strip codes. The code 474 may also include a particular color change corresponding to a given distance along the ribbon 472. Code 474 can take the form of a graphic on the drive ribbon. The drug type, drug amount and drug quantity can be determined by screen printing. , and other information readable by the image sensor 476, such as other forms of information. It is also possible.

[0356] In the embodiment of Figures 212 and 215, the sensor can be part of the cassette. Alternatively, it can be used with a cassette and reel that allows the sensor to see the drive ribbon. Being part of a reusable module with cooperating windows on the available modules FIG. 216 facilitates the use of sensors on reusable modules, If not, a control system similar to that of the embodiment of Figures 212-215 can be used. 1 shows a device having alternative configurations that can be used.

[0357] In the embodiment of FIG. 216, the cassette 480 is disposed on the inward facing surface of the drive ribbon 482. The reusable module holds a rotatable drive ribbon 482 having a cord 484 attached thereto. Module 486 is shown in Figs. 121-126, 127-132, 135 and 136. Extending from the proximal leg 492 is a drive ribbon 4 A sensor attached to its free end to read code 484 on the inward facing surface of 82. 488 and stem 490.

[0358] Any of the devices described herein may include a controller (herein referred to as an electronic module). The display may include a display, such as a 2D display, a 3D display, or a 4D display. One or more light-emitting diodes, electronic ink technology, or liquid crystal technology The display may include an electronic controller mounted within the housing. The controller is connected to and controlled by a controller or computing assembly. For example, it includes conventional components such as a processor, a power supply, and memory. any one of the devices described herein, including causing an indication of a dose received. The electronic characteristics of the device are programmed to achieve the set The dose is electrically connected to a dose setting and / or dose delivery drive mechanism and a controller. The presence or absence of a signal is determined by interaction with any one or more of the sensing systems connected via wires or wirelessly. The controller may be configured to detect the position of the drive ribbon member relative to the actuator. and detecting a dose delivered by a drug delivery device based on the rotation or linear extension of the detected dose. The control logic operates to perform the operations described herein, including The controller uses the sensors and the RPMs to create a database, lookup table, or is the electrical location of a precise and / or absolute position from other data stored in memory. The circuitry of each component is determined by correlating its electrical characteristics (such as voltage or resistance) Dose setting based on drive ribbon parameters such as rotational position and / or linear position The controller is operable to determine data from each sensor band and the number of revolutions. A precise location from a database, lookup table, or other data stored in memory. Relating electrical properties (such as voltage or resistance) to location and / or absolute position and determining the rotational and / or linear position of each component based on the rotational and / or linear position of the component. The device is operable to determine the dosage delivery by determining the position of the moving ribbon. The controller stores the detected dose in a local memory (e.g., internal flash memory or The controller is operable to store the The device transmits a signal representing the detected dose via Bluetooth Low Energy (BLE) or other via a suitable short-range or long-range wireless communication protocol, Illustratively, the BLE control The control logic and the controller are integrated on the same circuit.

[0359] Although the present invention has been described as having an exemplary design, the present disclosure is not intended to be limiting. and may be further modified within the scope of the present invention. It is intended to cover any variations, uses, or adaptations of the invention using its general principles. .

[0360] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0361] 1. Drug delivery for use with a container having a container body that holds a drug and defines an exit port. A device, comprising: a container including a piston disposed within a container body, the piston within the container body The advancement of the ton couples with the reservoir in the drug delivery device, releasing the drug through the outlet. a housing adapted to move a piston in the container; and a piston coupled to the housing and adapted to move a piston in the container. and a drive assembly adapted to drive the distal edge portion and the proximal edge portion. a drive shaft having a pivot portion and being progressively movable between a retracted configuration and an extended configuration about the drive shaft; a drive ribbon having a retracted portion that defines a spiral; wherein an expanded portion of the drive ribbon in the expanded configuration defines a helix. a slide engaging the drive ribbon and rotatable relative to the drive ribbon and the housing. a thrust member, the drive ribbon being adapted to move in response to rotation of the thrust member toward the housing or housing. The storage device is movable between a stored configuration and an extended configuration without any rotation relative to the device. and a last member.

[0362] 2. The device of embodiment 1, wherein the thrust member is axially stationary.

[0363] 3. The thrust member includes a helical thread engageable with the drive ribbon, the device further comprising: A drive ribbon is fixed relative to the housing for rotation and is engaged with the drive ribbon for extending the drive ribbon. A rotation constraint member that prevents relative rotation between the inserted portion and the rotation constraint member is provided in the embodiment 1-2. 2. A device according to claim 1 ,

[0364] 4. One of the rotational restraining member and the extended portion of the drive ribbon has an axially extending key. the other of the rotational constraint member and the extended portion of the drive ribbon is adapted to receive the key. 4. The device of embodiment 3, wherein the keyway defines an axially extending keyway for receiving the key.

[0365] 5. The rotational constraint member is in an engaged position where the rotational constraint member is engaged with the drive ribbon to prevent rotation. 5. The device of any one of aspects 3-4, wherein the drive ribbon is disposed radially outward of the drive ribbon at vinegar.

[0366] 6. The rotational constraint member is in an engaged position where the rotational constraint member is engaged with the drive ribbon to prevent rotation. 5. The device of any one of aspects 3-4, wherein the drive ribbon is disposed radially inward of the drive ribbon at vinegar.

[0367] 7. The helical thread is attached to the half of the drive ribbon at the engagement position where the helical thread is engaged with the drive ribbon. The device of any of aspects 3-6, wherein the device is positioned radially outward.

[0368] 8. The method of any one of aspects 3-7, wherein the thrust member is axially captured by a rotational restraining member. device.

[0369] 9. The helical thread is connected to the half of the drive ribbon at the engagement position where the helical thread is engaged with the drive ribbon. The device of any of aspects 3-8, wherein the device is disposed radially inward.

[0370] 10. In response to rotation of the thrust member, the thrust member moves axially in the proximal direction. a distal end of the drive ribbon that remains axially stationary and a piston that moves within the vessel body; To advance the device, the thrust member and the extended portion of the drive ribbon are moved distally. 10. The device of any of embodiments 1-9, wherein the device is moved axially by a force.

[0371] 11. The thrust member includes a helical thread engageable with the drive ribbon, the helical thread The drive ribbon is disposed radially outward of the drive ribbon at an engagement position where the drive ribbon is engaged with the drive ribbon. A vice is further rotationally fixed relative to the housing and engaged with the drive ribbon. A rotational constraint member is provided to prevent relative rotation between the extended portion of the drive ribbon and the rotational constraint member. The device of embodiment 10, comprising:

[0372] 12. The thrust member includes a helical thread engageable with the drive ribbon, the helical thread The drive ribbon is disposed radially inward of the drive ribbon at an engagement position where the drive ribbon is engaged with the drive ribbon. A vice is further rotationally fixed relative to the housing and engaged with the drive ribbon. A rotational constraint member is provided to prevent relative rotation between the extended portion of the drive ribbon and the rotational constraint member. The device of embodiment 10, comprising:

[0373] 13. The drive spring is further provided, and the drive spring extends the drive ribbon when the thrust member is rotated. When tensioned, the drive spring is tensioned and in response to the release of tension in the drive spring, the drive spring moves against the thrust member. and configured to axially advance an extended portion of the drive ribbon. A device according to any of 0-12.

[0374] 14. A drug delivery device for use with a container having a container body that holds a drug and defines an outlet. A delivery device, comprising: a container including a piston disposed within a container body, the piston being disposed within the container body. In a drug delivery device, the advancement of the stone releases the drug through an outlet, and the drug delivery device is coupled to a reservoir. a housing adapted to move a piston in the container; and a piston coupled to the housing and adapted to move a piston in the container. and a drive assembly adapted to drive the distal edge portion and A drive ribbon having a proximal edge portion and having a retracted configuration and an extended configuration, The retracted portion of the drive ribbon defines a spiral, and the retracted portion of the drive ribbon in the extended configuration defines a spiral. The expanded portion defines a helix, and the drive ribbon expands from a retracted configuration about the drive shaft. a drive ribbon that is movable incrementally from the retracted configuration to the extended configuration, the drive ribbon rotating during the movement from the retracted configuration to the extended configuration. and a drive ribbon, the drive assembly and the drive ribbon being in a coaxial relationship. Reach device.

[0375] 15.Furthermore, a drive ribbon is disposed radially inside the drive ribbon to drive the drive ribbon to rotate. and a drive member configured to control movement of the drive ribbon between the retracted configuration and the extended configuration. and a collar including a helical thread engaged radially outwardly of the drive ribbon. The device described in.

[0376] 16. Further, a drive member is disposed radially inward of the drive ribbon and configured to drive the drive member to rotate. and a drive member configured to control movement of the drive ribbon between the retracted configuration and the extended configuration. and a helical screw engaged with the drive ribbon.

[0377] 17.Furthermore, a drive ribbon is disposed radially outward of the drive ribbon to drive the drive ribbon to rotate. 15. The device of embodiment 14, comprising a drive member configured as follows:

[0378] 18. The driving member may be a ring gear, multiple ring gears, a belt, multiple planetary gears, a warp gear, etc. 18. The device of embodiment 17, which is a mechanical gear or a key actuation device.

[0379] 19. In one embodiment, the drive ribbon defines a plurality of slots engageable by the drive member. 8. The device according to claim 8.

[0380] 20. The method of claim 18, wherein the drive ribbon defines a plurality of ribs engageable by the drive member. The device described.

[0381] 21. A drug delivery device for use with a container having a container body that holds a drug and defines an outlet. A delivery device, comprising: a container including a piston disposed within a container body, the piston being disposed within the container body. In a drug delivery device, the advancement of the stone releases the drug through an outlet, and the drug delivery device is coupled to a reservoir. a housing adapted to move a piston in the container; and a piston coupled to the housing and adapted to move a piston in the container. and a drive assembly adapted to drive the distal edge portion and A drive ribbon having a proximal edge portion and having a retracted configuration and an extended configuration, The retracted portion of the drive ribbon defines a spiral, and the retracted portion of the drive ribbon in the extended configuration defines a spiral. The expanded portion defines a helix, and the drive ribbon expands from a retracted configuration about the drive shaft. responsive to movement of the drive ribbon from the retracted configuration to the extended configuration. The drive ribbon defines a transition portion disposed between the retracted portion and the extended portion. , along the transition portion, the distal and proximal edge portions of the drive ribbon are not engaged together; a drive ribbon; and a drive member engaged with the drive ribbon to drive rotation of the drive ribbon, a drive member engaged with a stored or transition portion of the drive ribbon. device.

[0382] 22. The device of embodiment 21, wherein the drive member is a reciprocating drive member.

[0383] 23. The method of claim 22, wherein the reciprocating drive member engages a radially inwardly facing surface of the drive ribbon. Devices listed.

[0384] 24. The reciprocating drive member is movable in a first direction and an opposite second direction, A moving member allows relative motion between the drive member and the drive ribbon in a first direction and The drive ribbon and the drive member are connected to each other so as to prevent relative motion between the drive member and the drive ribbon in two directions. 23. The device of claim 22, further comprising at least one flexible ratchet member that is engageable. vinegar.

[0385] 25. Further comprising a plurality of ratchet members engaging the radially outwardly facing surfaces of the drive ribbons. The method of claim 24, further comprising at least one stationary ratchet member secured to the housing. Devices listed.

[0386] 26. The device of embodiment 21, wherein the drive member includes a worm gear engageable with the drive ribbon. Vice.

[0387] 27. A storage bobbin for a stored portion of the drive ribbon includes a drive member, embodiment 21 The device described in.

[0388] 28. A drive ribbon includes a plurality of sensor targets arranged at predetermined intervals along the drive ribbon. the device further comprising a sensor adapted to detect a sensor target. a detected sensor target passing the sensor during movement of the drive ribbon toward the extended configuration; Any of the embodiments 1-27, wherein the movement of the get is used to control the movement of the drive ribbon. or the device described herein.

[0389] 29. A sensor target is disposed on the radially outward surface of the extended portion of the drive ribbon. 29. The device of embodiment 28,

[0390] 30. A sensor target is disposed on the radially inward surface of the extended portion of the drive ribbon. 29. The device of embodiment 28,

[0391] 31. The drive ribbon includes a plurality of protrusions spaced at predetermined intervals along the drive ribbon; The device further comprises a control member disposed adjacent the expanded portion, the control member , selectively movable between a position that allows rotational passage of the projection through the control member and another position and a control member prevents passage of the projections, thereby preventing rotation and expansion of the drive ribbon. The device of any of embodiments 1-27, wherein the device stops expansion.

[0392] 32. A drug delivery device for use with a container having a container body for holding a drug and defining an outlet. A delivery device, comprising: a container including a piston disposed within a container body, the piston being disposed within the container body. In a drug delivery device, the advancement of the stone releases the drug through an outlet, and the drug delivery device is coupled to a reservoir. a housing adapted to move a piston in the container; and a piston coupled to the housing and adapted to move a piston in the container. and a drive assembly adapted to drive the distal edge portion and A drive ribbon having a proximal edge portion and having a retracted configuration and an extended configuration, The retracted portion of the drive ribbon defines a spiral, and the retracted portion of the drive ribbon in the extended configuration defines a spiral. The expanded portion defines a helix, and the drive ribbon is adapted to move progressively from the retracted configuration to the extended configuration. a drive ribbon that is movable and whose movement from a retracted configuration to an extended configuration defines a drive axis; a ribbon; and a drive mechanism operatively coupled to the drive ribbon and defining a secondary axis parallel to the drive axis. a drive ribbon for moving the drive ribbon from the retracted configuration to the extended configuration, and a drive mechanism for generating a force to deliver the drug to the drug delivery device.

[0393] 33. The drive mechanism includes a spring aligned with the secondary shaft and, in response to setting the dose, The spring is in a tensioned configuration, and in response to the spring being released from the tensioned configuration, the spring Operable to generate a transmittable force to move the bong from a retracted configuration to an extended configuration. 33. The device of embodiment 32, wherein

[0394] 34. The drive mechanism includes a plunger disposed along a secondary axis, and the linear alignment of the plunger The actuator generates a force that is transmitted to the drive ribbon to move the drive ribbon from the retracted configuration to the extended configuration. 33. The device of embodiment 32, configured to

[0395] 35. The drive mechanism comprises an electric motor drivingly coupled to an element disposed along a secondary axis. an electric motor generating a force transmitted to the drive ribbon to move the drive ribbon from the stored configuration; 33. The device of embodiment 32, wherein the device is configured to move the movable member from a fixed position to an extended position.

[0396] 36. Aspect 35, in which the element disposed along the secondary axis is a drive shaft of an electric motor. The device described in.

[0397] 37. The drive ribbon and drive mechanism are disposed within a housing, and the container is disposed within the housing. The device of any of aspects 32-36, which is removably attachable.

[0398] 38. The drive mechanism is disposed within the housing, and the device further comprises a cartridge housing. Comprising a bell, a drive ribbon is disposed within the cartridge housing, a container is attached to the cartridge housing, and the cartridge housing is removably fixable to the housing, the device according to any one of aspects 32-37.

[0399] 39. The drive mechanism includes a spring aligned with the secondary axis and, in response to setting of a dosage, the spring is under tension and, when the tension is released, the spring generates a force transmitted to the drive ribbon to move the drive ribbon from a retracted configuration to an extended configuration, the device according to aspect 3 8.

[0400] 40. The drive mechanism includes an electric motor drivingly coupled to an element disposed along the secondary axis and the electric motor is configured to generate a force transmitted to the drive ribbon to move the drive ribbon from a retracted configuration to an extended configuration, the device according to aspect 38.

[0401] 41. 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 fixed to the housing and thereby supplying power to the electric motor, the device according to aspect 40.

[0402] 42. The housing is adapted to receive one of a plurality of cartridges, each of the cartridges including a cartridge housing having a drive ribbon disposed therein and a container attached to the cartridge housing, and each of the cartridges being interchangeably and removably fixable to the housing, the device according to any one of aspects 32-41.

[0403] ​​​ 43. The electronic module is disposed on the housing, and the cartridge is disposed on the cartridge housing. a housing and a drive ribbon, the cartridge further comprising a digital memory device When the electronic module is coupled to the housing, the digital memory data of the cartridge is After communicating with the device and completing the injection procedure, the electronic module stores data related to the injection procedure. 39. The device of claim 38, configured to record in a digital memory device .

[0404] 44. The data recorded on the digital memory device indicates the amount of medication remaining in the container. A device as described in embodiment 43, comprising associated data.

[0405] 45. A device according to any of aspects 1-44, wherein the cartridge is disposable.

[0406] 46. ​​The drive mechanism comprises an electric motor drivingly coupled to an element disposed along a secondary axis. an electric motor generating a force transmitted to the drive ribbon to move the drive ribbon from the stored configuration; 43. The device of embodiment 42, wherein the device is configured to move the movable member from a fixed position to an extended position.

[0407] 47. An electronic module is disposed on the housing, and each of the plurality of cartridges and an electronic module coupled to the housing, the electronic module further comprising a digital memory device. The electronic module communicates with the cartridge's digital memory device and, after completing the injection procedure, The module is configured to record data relating to the injection procedure in a digital memory device. The device of embodiment 46,

[0408] 48. A drive ribbon includes a plurality of sensor targets arranged at predetermined intervals along the drive ribbon. the device further comprising a sensor adapted to detect a sensor target. whereby the sensor target passes the sensor when the drive ribbon is extended. 47. The sensing of the movement of the drive ribbons to the extended configuration. The device described in.

[0409] 49. The sensor is supported by the housing, and the sensor target is a stretched portion of the drive ribbon. The device of embodiment 48, wherein the device is disposed on a radially inward surface of the tensioned portion.

[0410] 50. A drug delivery device for use with a container having a container body that holds a drug and defines an outlet. A delivery device, comprising: a container including a piston disposed within a container body, the piston being disposed within the container body. In a drug delivery device, the advancement of the stone releases the drug through an outlet, and the drug delivery device is coupled to a reservoir. a housing adapted to move a piston in the container; and a piston coupled to the housing and adapted to move a piston in the container. and a drive assembly adapted to drive the distal edge portion and A drive ribbon having a proximal edge portion and having a retracted configuration and an extended configuration, The retracted portion of the drive ribbon defines a spiral, and the retracted portion of the drive ribbon in the extended configuration defines a spiral. The expanded portion defines a helix, and the drive ribbon is adapted to move progressively from the retracted configuration to the extended configuration. a piston movable within the container body to advance the piston from the retracted configuration to the extended configuration; The movement of the ribbon defines a drive axis, and one of the distal and proximal edge portions has a plurality of edge projections. and the other of the distal edge portion and the proximal edge portion is opposed when the drive ribbon is in an expanded configuration. a drive ribbon defining a plurality of openings configured to interlockingly receive corresponding edge projections; A drug delivery device comprising:

[0411] 51. The radially outwardly facing surface of the drive ribbon is provided with a plurality of equally spaced surface protrusions, 51. The method of claim 50, wherein each of the first and second grooves is bounded by an intersection. Devices listed.

[0412] 52. When the drive ribbon is in an expanded configuration, a portion of the surface protrusion is overlapping one of the distal and proximal edge portions in a manner that extends over the other of the portions; A device as described in embodiment 51.

[0413] 53. In a drug delivery device, a module housing, a drive including a motor disposed thereon and a drive gear operably connected to a shaft of the motor; a module and a cassette housing configured to couple to the module housing. a container body for holding the medicament and defining an outlet, and advancing the piston within the vessel body to eject the liquid through the outlet. a drive ribbon that is axially expandable in a progressive manner to release the drug; and a drive gear that is operable to a thrust member including a drive gear element coupled to said drive ribbon, said thrust member engaging said drive ribbon; and a thrust member movable to expand or retract the drug delivery device. Vice.

[0414] 54. The cassette housing according to embodiment 53, wherein the cassette housing houses the drive ribbon and the thrust member. The device described.

[0415] 55. The cassette housing is connected to the electric motor of the drive module, and an electronic module located in the At least one for powering a memory containing data relating to a serial number The cassette housing is attached to the module housing. When the electronic module of the module housing is in communication with the electronic module of the module housing, The device described.

[0416] 56. The cassette housing is fixed to the module housing. The device of any of embodiments 53-55, comprising attachment features for coupling.

[0417] 57. The mounting feature allows the cassette housing to be selectively removed from the module housing. 57. The device of embodiment 56, wherein the device is configured to allow the device to be removed.

[0418] 58. The module housing is now fully assembled. The cassette housing is now fully assembled. 58. The device of embodiment 57, comprising a release latch to enable it to be removed.

[0419] 59. The cassette is further disposed axially from the thrust member along the cassette housing. a collar positioned on the drive ribbon such that the collar is aligned with a corresponding axial groove defined by the drive ribbon; The device of any of embodiments 53-58, comprising one or more axial ribs received by vinegar.

[0420] 60. A thrust member is disposed radially outward of the drive ribbon, the thrust member being As described in embodiment 59, the ribbon includes a corresponding lateral groove. device.

[0421] 61. In addition, the type of drug, the original amount of drug, the angular position of the drive ribbon, the axial direction of the drive ribbon, the orientation of the drive ribbon, the speed of extension and / or retraction of the drive ribbon, and the stopping of the drive ribbon. At least one of the driving ribbons is connected to the driving ribbon for determining the driving ribbon movement. and an encoder sensor configured to detect a coding pattern defined by the 61. The device of any of embodiments 53-60, comprising an electronic module for receiving the

Claims

1. for removably mounting to the drive module to define a medication delivery device. A medication cassette comprising: The drive module has a module housing and is disposed within the module housing. and a drive mechanism for The drug cassette comprises: to be attached to and detached from the drive module A cassette housing configured as follows: a container body holding the medicament and defining an outlet; A piston disposed within the container body; A drive ribbon disposed within the cassette housing to advance the piston. wherein the drive ribbon includes a distal edge portion and a proximal edge portion, the drive ribbon being a drive The actuator is progressively movable about an axis between a stored configuration and an extended configuration, The retracted portion of the drive ribbon defines a spiral, and the drive ribbon in the expanded configuration a drive ribbon, the expanded portion of the ribbon defining a helix; A drive member operatively engaged with the drive ribbon, the drive module comprising: a drive member configured to rotate, the drive ribbon being adapted to rotate in response to the rotation of the drive member; The piston is then axially expanded to advance within the container body and deliver the drug via the outlet. the drive member discharging The drug cassette.

2. The cassette of claim 1 , wherein the drive member comprises a geared element.

3. a rotational constraint member engaged with the drive ribbon; One of the rotational restraining member and the extended portion of the drive ribbon extends axially. a key for engaging said rotational constraint member and said extended portion of said drive ribbon; a keyway extending axially therethrough for receiving said key, and said rotational constraint member defining said A rotation restraining member is engaged with the drive ribbon to prevent rotation of the drive ribbon in an engaged position.

10. The cassette of claim 1, disposed radially outward of the bone.

4. a rotational constraint member engaged with the drive ribbon; One of the rotational restraining member and the extended portion of the drive ribbon is provided with an axially extending the other of the rotational restraining member and the extended portion of the drive ribbon defines a The rotational restraining member defines an axially extending keyway for receiving the rotational restraining member. A member is provided at the half of the drive ribbon in an engaged position where the member is engaged with the drive ribbon to prevent rotation. The cassette of claim 1 , wherein the first and second electrodes are disposed radially inward.

5. 3. The cartridge of claim 2, wherein the drive member includes an internal helical thread that engages the drive ribbon. set.

6. Further, the cassette housing is attached to the drive module and the drive module a latch engagement element configured to enable the latch engagement element to be removed from the module; 2. The cassette of claim 1.

7. Further, a mounting for fixedly coupling the cassette housing to the drive module. The cassette of claim 1 further comprising a mounting feature.

8. a bearing member fixed directly to a distal end of the drive ribbon; 2. The cassette of claim 1, wherein said bearing member is in engagement with said piston.

9. a radially outwardly facing surface of the drive ribbon comprising a plurality of regularly spaced surface protrusions; Each of the surface protrusions is bounded by intersecting first and second grooves, and the drive When the moving ribbon expands in the axial direction, the first groove expands helically and the second groove expands axially. The cassette of claim 1 , wherein the cassette is extended in a direction perpendicular to the axis of the axis.

10. The drive member includes a helical thread that engages one of the first grooves of the drive ribbon, The cassette housing has a plurality of axial ribs that engage the second grooves of the drive ribbon.

10. The cassette of claim 9 comprising:

11. One of the distal edge portion and the proximal edge portion defines a plurality of edge projections, and the other of the proximal edge portions is interlocked when the drive ribbon is in the expanded configuration. The present invention relates to a method for manufacturing a semiconductor laser, the method comprising:

2. The cassette described in 1.

12. 4. The drive ribbon of claim 3, wherein the drive ribbon comprises a series of raised ribs on an inward facing surface of the drive ribbon.

2. The cassette described in 1.

13. In response to rotation of the drive member, the drive ribbon rotates in any direction relative to the container body.

13. The method of claim 1, wherein the storage device is movable between the stored configuration and the extended configuration without any movement. The cassette described in

14. In a drug delivery device, A cassette according to claim 13; a module housing and a drive member disposed therein for rotating the drive member of the cassette; and a drive module having a drive mechanism configured to drive the drug delivery device. 。

15. the drive mechanism includes a drive gear and an electric motor drivingly coupled to the drive gear; The drive gear is arranged to rotate forward when the cassette is installed in the module housing. a drive member configured to drive the drive ribbon from the storage configuration; to the extended configuration via the drive gear and the drive member.

15. The device of claim 14 configured to generate a force that is transmitted to the bone.

16. the modular housing adapted to receive any of a plurality of cassettes; Each of the cassettes is replaceably and removably mounted in the module housing. The device of claim 15 which is fixable.

17. the module housing includes an electronic module; The cassette further comprises a digital memory device, and the electronic module further comprises When coupled with the module housing, the digital memory device of the cassette After communicating and completing the injection procedure, the electronic module stores data related to the injection procedure.

17. The digital memory device of claim 16, further comprising: Vice.

18. The electronic module determines the type of drug, the original amount of drug, the angular position of the drive ribbon, the axial position of the drive ribbon, the rate of extension and / or retraction of said drive ribbon, and to determine at least one of a stop of the drive ribbon or a movement of the drive ribbon. A coding pattern defined by the drive ribbon of the cassette to control the 20. The device of claim 17, in communication with an encoder sensor configured to detect Chair.

19. The drive ribbon includes a plurality of sensor arrays spaced at predetermined intervals along the drive ribbon. said module housing or said cassette further comprising: a sensor adapted to communicate with the module and to detect the sensor target; This allows the sensor target to pass the sensor when the drive ribbon is extended. Sensing the movement of the injection device is used to detect data related to the injection procedure.

20. The device of claim 17.

20. The drive mechanism includes a spring, and in response to setting a dose, the spring is in a tensioned configuration and In response to the release of the spring from the tensioning configuration, the spring urges the drive ribbon toward the storage structure. and operable to generate a transmittable force to move the flexible member from the extended configuration to the expanded configuration. The device of claim 14.

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