Method for delivering drug

Abstract

To disclose a method and system for driving a plunger in a medicine reservoir.SOLUTION: In one embodiment, a variable friction element interconnects between a pushing shaft and a wall of the reservoir. For example, rotation of a driving element in a first direction relative to the pushing shaft may advance the pushing shaft in the reservoir. The friction element may increase friction resistance to rotation of the pushing shaft in the first direction in comparison with frictional resistance to advancing of the pushing shaft. For example, the increased friction may result from wedging a radial element between the pushing shaft and the wall of the reservoir.SELECTED DRAWING: Figure 4A

Description

[Technical field]

[0001] The present invention relates in one embodiment to an anti-rotation friction coupling, particularly but not exclusively to a coupling for preventing rotation of a plunger driver of a drug delivery device. [Background technology]

[0002] From the disclosure of U.S. Patent No. 7,967,795 by Oz Cabiri, a cartridge interface includes a drive plunger having an outer shaft and a driver including an inner shaft. A face assembly, the inner shaft mating with an intermediate shaft, the intermediate shaft mating with an outer shaft, the shafts being telescopically movable relative to one another such that rotation of the driver advances the drive plunger away from the driver. Summary of the Invention

[0003] According to one aspect of an embodiment of the invention there is provided an assembly for driving a plunger in a drug reservoir, the plunger dividing a drug in a distal portion of the reservoir and a proximal opening of the reservoir, the assembly comprising a telescoping shaft that extends upon rotation of a drive element in a first rotational direction relative to the distal shaft, a distal end of the distal shaft engageable with the plunger, and a radially shaped element extending from the distal shaft to contact an inner wall of the reservoir, the element constructed and arranged to be clamped between the inner wall and the distal shaft when the distal shaft is rotated in the first rotational direction.

[0004] According to one embodiment of the invention, the element comprises a substantial sprag having a longitudinal axis, the longitudinal axis intersecting the inner wall.

[0005] According to one embodiment of the present invention, the major axis intersects the inner wall at an angle ranging from 91 degrees to 120 degrees from the first rotational direction.

[0006] According to one embodiment of the invention, the element comprises a virtual beam with a desired curvature in a direction opposite to the first rotational direction.

[0007] According to one embodiment of the invention, the assembly further comprises a plunger interface engageable with the plunger, the plunger interface non-rotatably interconnecting the distal shaft and the plunger when engaged with the plunger.

[0008] According to one embodiment of the invention, the assembly further comprises a vent for releasing gas from the space between the element and the plunger.

[0009] According to one embodiment of the invention, the radial forming element is disposed proximally relative to the distal end of the distal shaft.

[0010] According to one embodiment of the invention, the fixation is longitudinal such that movement of the distal shaft away from the reservoir reduces normal forces between the radial form element and the inner wall.

[0011] According to one embodiment of the invention, the resistance force caused by friction between the radial shape element and the inner wall to movement of the distal shaft in a first rotational direction is greater than the frictional resistance force between the radial shape element and the inner wall to movement of the distal shaft in a direction opposite to the first rotational direction.

[0012] According to one embodiment of the invention, the assembly defines a second friction element extending from the drug delivery device and contacting an outer wall of the reservoir when the reservoir is inserted into the drug delivery device, the second friction element being constructed and arranged to lock between the outer wall and the reservoir when the reservoir rotates in a second rotational direction.

[0013] According to an embodiment of the invention, the second direction of rotation is opposite to the first direction of rotation.

[0014] According to one aspect of an embodiment of the present invention, there is provided a method for advancing a plunger in a drug reservoir, the method comprising the steps of: providing a telescoping assembly that extends by rotating a driver in a first direction relative to an extruded shaft engaged with a driver, the extruded shaft including a friction element that contacts a wall of the reservoir, rotating the driver in the first direction, fixing the friction element between the extruded shaft and the wall by said rotation, inhibiting rotation in the first direction by said fixing, and further releasing the clamping of the friction element to facilitate advancement of the extruded shaft.

[0015] According to one embodiment of the present invention, the clamping step is essentially a step of only retarding the rotation of the extrusion shaft relative to the reservoir.

[0016] According to one embodiment of the present invention, the tightening step includes increasing the normal force.

[0017] According to one embodiment of the invention, the method further includes reducing a normal force between the friction element and a wall of the reservoir as the extruded shaft moves distally.

[0018] According to one embodiment of the invention, the drug reservoir includes a plunger, and the method further includes reducing a normal force between the friction element and a wall of the reservoir when the pusher shaft pushes the plunger distally.

[0019] According to one embodiment of the present invention, a drug delivery device comprises a housing including a groove, a drug reservoir that fits within the groove, and a friction element extending from the housing toward the groove that contacts an outer wall of the reservoir when the reservoir is inserted into the groove, the element being configured and arranged to be clamped between the outer wall and the reservoir when the reservoir rotates in a first rotational direction.

[0020] According to one embodiment of the invention, the assembly further comprises a telescoping shaft that extends upon rotation of the drive element in a first rotational direction relative to the shaft, and a second friction element that restrains rotation of the shaft relative to the reservoir.

[0021] According to one embodiment of the invention, the groove is cylindrical and includes an opening at one end, the reservoir slides longitudinally through the opening into the groove, and the friction element has an increased frictional resistance to movement in a first rotational direction relative to the frictional resistance to movement in a longitudinal direction.

[0022] According to one aspect of an embodiment of the present invention, a method of delivering a drug comprises providing a reservoir containing the drug and a delivery device including a groove and a friction element, inserting the reservoir longitudinally into a passageway, and fixing the reservoir against the friction element by rotating the reservoir relative to the device.

[0023] According to one aspect of the invention, there is provided an assembly for driving a plunger in a drug reservoir, the plunger dividing a drug in a distal portion of the reservoir and a proximal opening of the reservoir, the assembly comprising: a telescoping shaft extending by rotation of a drive element in a first rotational direction relative to a distal shaft; a distal end of the distal shaft engageable with the plunger; a radial shaped element extending from the distal shaft and contacting an inner wall of the reservoir; and a vent hole allowing the passage of gas from an interior of the reservoir between the plunger and the radial shaped element towards the proximal opening of the reservoir, the vent hole being formed in at least one component selected from the group consisting of the radial shaped element, between the radial shaped element and a side wall of the reservoir, within the distal shaft, and between the distal shaft and the radial shaped element.

[0024] According to one embodiment of the invention, the assembly includes at least two vents in at least two components, the at least two vents being positioned such that gas passing through a first vent in a first one of the components communicates with a second vent in a second one of the components.

[0025] According to one embodiment of the invention, the assembly further comprises a user indicator visible from outside the drug reservoir, said assembly being capable of moving the indicator along a path, the position of said indicator indicating the status of the assembly.

[0026] According to one embodiment of the invention, the indicator is not visible from outside the reservoir on at least a portion of the path.

[0027] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although similar or equivalent methods and materials described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including its provisions, will control. Additionally, the materials, methods, and examples are illustrative only and are not necessarily limiting. [Brief description of the drawings]

[0028] An embodiment of the present invention has been described herein by way of example only with reference to the accompanying drawings. By now referring in detail and directly to the drawings, it will become more apparent that the specific examples shown are illustrative of embodiments of the present invention and are for the purposes of clarity and explanation, such that those skilled in the art will understand that the method of the embodiment of the present invention can be practiced by the accompanying description of the drawings.

[0029] In the figure, [Figure 1] 1 is a flow chart illustrating a method for facilitating movement of a plunger driver according to an embodiment of the present invention. [Diagram 2] FIG. 13 is a flow chart illustrating a method for driving a plunger according to an embodiment of the present invention. [Figure 3A] FIG. 2 is a block diagram of an assembly for driving a plunger according to an embodiment of the present invention. [Figure 3B] 1 is a schematic diagram of a sprag element according to an embodiment of the present invention that resists movement in an obstructing direction and allows movement in a direction other than the obstructing direction. [Figure 3C] 1 is a schematic diagram of a sprag element according to an embodiment of the present invention that resists movement in an obstructing direction and allows movement in a direction other than the obstructing direction. [Figure 4A] FIG. 1 illustrates a plunger drive assembly and a drug reservoir in threaded connection with a plunger interface according to an embodiment of the present invention. [Figure 4B] FIG. 1 illustrates a plunger drive assembly and a drug reservoir in threaded connection with a plunger interface according to an embodiment of the present invention. [Figure 4C] FIG. 1 illustrates a plunger drive assembly and a drug reservoir in threaded connection with a plunger interface according to an embodiment of the present invention. [Figure 4D] FIG. 1 illustrates a plunger drive assembly and a drug reservoir in threaded connection with a plunger interface according to an embodiment of the present invention. [Figure 4E] FIG. 1 illustrates a plunger drive assembly and a drug reservoir in threaded connection with a plunger interface according to an embodiment of the present invention. [Figure 4F] FIG. 1 illustrates a plunger drive assembly and a drug reservoir in threaded connection with a plunger interface according to an embodiment of the present invention. [Diagram 5] FIG. 13 is a perspective view of a pusher rod that drives a plunger and a friction element that facilitates forward linear movement according to an embodiment of the present invention. [Figure 6A] FIG. 1 is a cross-sectional view of a plunger including a flexible beam-like anisotropic friction element for pushing a rod, according to an embodiment of the present invention. [Figure 6B]FIG. 1 is a cross-sectional view of a plunger including a flexible beam-like anisotropic friction element for pushing a rod, according to an embodiment of the present invention. [Figure 7A] FIG. 13 is a side view of a plunger pushing assembly that reduces frictional forces when engaged with the plunger, according to an embodiment of the present invention. [Figure 7B] FIG. 13 is a side view of a plunger pushing assembly that reduces frictional forces when engaged with the plunger, according to an embodiment of the present invention. [Figure 8] FIG. 2 is a perspective view of a rod including a sprag friction element and a ram plunger interface according to an embodiment of the present invention. [Figure 9] FIG. 2 is a perspective view of a rod including a substantial sprag friction element according to an embodiment of the present invention. [Figure 10A] 1 is a perspective view of a cartridge including wheeled friction elements according to an embodiment of the present invention. [Figure 10B] FIG. 1 is a perspective view of a wheeled friction element with a shaft mounting according to an embodiment of the present invention. [Figure 10C] FIG. 2 is a perspective view of a wheeled friction element without a shaft mounting according to an embodiment of the present invention. [Figure 11] FIG. 2 is a perspective view of a cartridge held by an external annular friction element according to an embodiment of the present invention. [Figure 12A] FIG. 2 is a perspective view of a cartridge including an external semi-annular friction element according to an embodiment of the present invention. [Figure 12B] FIG. 1 is a perspective view of a cartridge including an external semi-annular friction element mounted within a drug delivery device according to an embodiment of the present invention. [Figure 13A] 13 is a flow chart illustrating a method for retaining a plunger driver in a reservoir according to an embodiment of the present invention. [Figure 13B] 1A-1D are flow chart diagrams illustrating the assembly and / or use of a drug delivery device and / or drug cartridge according to an embodiment of the present invention. [Figure 14A]1 illustrates a pharmaceutical cartridge according to an embodiment of the present invention. [Figure 14B] 1 illustrates a cartridge coupled to a delivery device, according to an embodiment of the present invention. [Figure 15] 1 illustrates a connection between a friction pad and a plunger driver according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] The present invention, in one embodiment of the present invention, relates to an anti-rotation friction coupling, and more particularly, but not exclusively, to a coupling for preventing rotation of a plunger driver and / or a reservoir of a drug delivery device.

[0031] One aspect of an embodiment of the present invention relates to a variable friction element that facilitates forward movement of the shaft in the drug reservoir. For example, forward movement of the extruded shaft can be driven by rotating a driver element relative to the extruded shaft. The friction element, for example, inhibits the extruded shaft from rotating with the driver element and / or inhibits rotation of the reservoir, facilitating relative rotation. Alternatively or additionally, the friction element may be designed to reduce frictional forces against the forward movement of the extruded shaft and / or the reservoir (facilitating forward movement in a desired direction).

[0032] In one embodiment, the friction element can facilitate and / or accelerate forward movement of the pusher shaft and / or plunger interface prior to contact with the plunger. Optionally, the resistance to forward movement by the friction element can be reduced and / or self-regulating to a minimal and / or negligible value as the pusher shaft pushes the plunger.

[0033] The term plunger as used herein refers to a piston element. For example, the plunger may include a plunger shaft, a plunger head, and / or a plunger seal and / or a coupling element. As used herein, the term / phrase plunger seal refers to a piston element that blocks the flow of a fluid. Optionally, the plunger seal includes and / or is integral with the piston head. For example, the seal may comprise a stopper and / or a gasket. In one embodiment, the term plunger refers to only the plunger seal. For example, the plunger includes a single sealing member that is pushed by a driver. Optionally, the driver may include an ejection shaft.

[0034] In one embodiment, the friction element can be tightened and / or configured to increase the normal force between the outer wall of the shaft and the inner wall of the reservoir when the shaft moves in a constrained direction relative to the reservoir. In one embodiment, the friction element is configured to tighten and / or increase the normal force between the outer wall of the shaft and the inner wall of the drug reservoir when the shaft moves in a constrained direction relative to the reservoir. Alternatively or additionally, the friction element is configured to eliminate and / or reduce the normal force between the outer wall of the shaft and the inner wall of the reservoir when said shaft moves in a desired direction relative to the reservoir. In one embodiment, the desired direction of movement is a direction that moves the rod closer to the plunger and / or allows ejection of the drug, e.g., forward or distal.

[0035] In one embodiment, the friction elements may include sprags and / or beams. For example, the beams may have a desired bending mode that produces anisotropic frictional forces. Optionally, the sprags and / or beams may include segmented elements. Alternatively or additionally, the sprags and / or beams may be integral with another element and / or another element. As used herein, the term substantially element (for example, substantially sprags and / or substantially beams) refers to an element that is unique with respect to another element. For example, the substantially sprags and / or beams may be radial shaped element portions (for example, the radial shaped element may include a disk) that have a reduced compressibility compared to the surrounding area. For example, the substantially sprags and / or beams may include pleats on the radial shaped element.

[0036] In one embodiment, a sprag may be an element supported between two surfaces at an angle such that movement of one of the surfaces in a first direction may compress the sprag and / or pinch the sprag between the two surfaces, resulting in an increased normal force and / or resistance to movement. Alternatively or additionally, movement of the surfaces in a direction different from the first direction may reduce the normal force and / or reduce the resistance to movement and / or reduce the resistance to another movement. A single substantial sprag and / or a single composite sprag may include portions of elements having properties that create a variable friction force between two surfaces such that movement in a first direction may compress the sprag, exerting stress on the sprag by increasing the resistance to movement and / or movement in a direction different from the first direction, reducing the resistance to any movement and / or movement opposite to the movement. For example, the frictional resistance to movement in the suppressed direction may be in the range of 2x to 4x, and / or in the range of 4x to 10x, and / or in the range of 10x to 100x, or greater than 100x, which is comparable to the frictional resistance to movement in another direction (e.g., the direction opposite to the first direction) and / or the frictional resistance to movement in the desired direction. For example, the frictional resistance to movement in the desired direction may be reduced by an amount in the range of 2x to 4x, and / or in the range of 4x to 10x, and / or in the range of 10x to 100x, or greater than 100x. By combining a step of reducing the frictional resistance to movement in the desired direction with a step of increasing the frictional resistance to movement in the undesired direction, it is possible to reduce and / or minimize the frictional resistance to movement in the desired direction while increasing and / or maximizing the resistance to movement in the other direction.

[0037] In one embodiment, the friction joint and / or plunger interface may include an air vent to prevent the accumulation of air pockets between the extrusion shaft and / or plunger interface when the extrusion shaft and / or plunger interface is in close proximity to the plunger seal.

[0038] In one embodiment, the friction element of the present invention can be used with various shapes of drug reservoirs and / or plungers. For example, the present invention may be configured with a standard syringe, cartridge, reservoir, and / or plunger. For example, the reservoir cavity may be cylindrical. For example, the reservoir cavity may have smooth walls.

[0039] In one embodiment, the friction element may include a user indicator. For example, the friction element may be colored and / or easily identifiable and / or illuminated. Optionally, the position of the friction element may be visible to the user, for example through a window in the device and / or a sidewall of the reservoir. The position and / or illumination of the friction element may optionally indicate the status of the device.

[0040] In one embodiment, movement of the friction element can indicate that the device is operational. For example, movement of the friction element can indicate that the device is activated before the anti-friction element reaches the plunger seal.

[0041] In one embodiment, the friction element and / or the base of the friction element (such as the support element and / or the connector) can change appearance depending on the state of the device. For example, the appearance can change when the friction element reaches the plunger seal.

[0042] In one embodiment, the indicator is certainly visible to the user throughout the entire path. Alternatively or additionally, the indicator is only visible over a portion of the path. For example, a window of the drug ejection device may only expose a portion of the path. Alternatively or additionally, the walls of the drug reservoir may be transparent over a portion of the path and / or non-transparent over another portion of the path. For example, the window and / or the reservoir may only expose a portion of the path. For example, the driver, base and / or friction element may be exposed upon contact with the plunger seal. The exposure optionally indicates that ejection has started. Alternatively or additionally, the driver, base and / or friction element may be exposed in an initial position and / or may be covered (for example, by a window and / or an opaque portion of the housing of the device) shortly after said point, for example, exposed or covered shortly after the driver has moved towards the plunger seal. For example, a change in appearance of the friction element may be an indicator that the system has started to operate and / or is operating properly.

[0043] In one embodiment, the plunger, driver, base, friction element, and / or plunger seal may be covered by the end of the passageway. By way of example, disappearance of the element may be an indication of successful completion of dispensing. By way of example, a marked portion of the driver may be covered by the plunger seal when the driver contacts the plunger seal.

[0044] In one embodiment, the window and / or reservoir wall may include a tinted pane over one or more portions of the pathway. For example, tinting may cause the driver, base, friction element, and / or plunger seal to change appearance upon reaching a certain point in the pathway. For example, the color change may indicate a change in state of the ejection device. In one embodiment, the indicator is dependent on components provided by the device manufacturer, for example, the friction element and / or driver element, and / or components of the delivery device (for example, to indicate a device-specific state). Alternatively or additionally, the indicator may be dependent on the drug packaging machine, for example, the plunger seal (for example, if the indicated state is related to a particular drug).

[0045] One aspect of an embodiment of the invention relates to an element that generates high friction as the extruded shaft moves with minimal external resistance and / or generates low friction as the extruded shaft extrudes against the plunger of the reservoir. By way of example, the plunger interface may be configured to allow the friction element to fold and / or bend away from the wall of the reservoir and / or generate low friction as the interface engages the plunger.

[0046] In one embodiment, the plunger interface may include a standard connector. By way of example, the plunger interface may include a thread that is threaded into the plunger. The interface may transmit linear force and / or rotational torque between the extruded shaft and the plunger. Alternatively or additionally, the interface may transmit linear force in one or more directions while transmitting limited and / or negligible torque between the extruded shaft and the plunger. By way of example, the plunger interface may include a screw thread. A friction element may inhibit rotation and / or facilitate linear movement of the extruded shaft until the screw interface reaches the plunger. When the screw element engages between the extruded shaft and the plunger, resistance is optionally added to forward movement of the extruded shaft and / or frictional forces inhibiting rotation of the extruded shaft are optionally reduced. Optionally, the interface or the extruded shaft is rotated to positively engage the screw thread. At one point where the threads engage (e.g., when the threads are fully threaded and / or fully engaged), the resistance to rotation of the plunger can optionally positively stop and / or reduce rotation of the extruder shaft and / or facilitate further linear advancement of the plunger and / or extruder shaft. Alternatively or additionally, the plunger interface may include a locking element, such as a plug and socket, that transfers torque and / or linear force between the extruder shaft and the plunger. Alternatively or additionally, the plunger may include a ram interface that pushes the plunger out without transferring significant rotational torque.

[0047] In one embodiment, the friction element can be adjusted depending on the drive system, injection duration, and / or plunger load. For example, in high viscosity deliveries where the syringe is heavily loaded, the friction element can be designed to provide a lower frictional resistance to forward movement. For example, in high injection speeds (e.g., in high pitch drive screws), the friction element can be designed to provide a lower frictional resistance to forward movement. For example, in a reservoir having a torque of about 100 g·cm generated by the drug extrusion during drug delivery, the friction element can provide a torque resistance of about 90 g·cm in the undesired direction and / or the plunger can provide a torque resistance of about 60 g·cm, such that the combined friction element and plunger resistance in the undesired direction is about 150 g·cm. More generally, the torque resistance of the friction element in the undesired direction may be in the range of 80-95%, and / or 65-80%, and / or 30-65%, and / or 5-30%, and / or 95-110%, and / or 110-175%, and / or 175-300% of the torque generated by the drug ejection when the drug is delivered. The combined torque resistance of the friction element and the plunger in the undesired direction may be in the range of 105-130%, and / or 130-170%, and / or 170-250%, and / or 250-500% of the torque generated by the drug ejection when the drug is delivered. The torque generated by the drug ejection when the drug is delivered depends, for example, on the lumen of the injection needle and / or the cross-sectional area of ​​the reservoir and / or the viscosity of the drug and / or the pitch of the drive screw. For example, for a 27 gram ultra-thin walled delivery needle and an 8.65 mm bore reservoir with a drug having a viscosity between 30-50 centipoise and an axial plunger speed of 1-3 cm / min, the axial force to expel the drug may be in the range of, for example, 0.2-3 kgf, and the delivery torque to deliver the drug may be in the range of, for example, 50-150 g cm on the threads. The combined torque resistance of the frictional elements and the plunger in the undesired direction may be in the range of, for example, 50-300 g cm. For example, increasing the viscosity, thread pitch, cross-sectional area, and / or decreasing the needle bore size allows for an increase in delivery torque.Table 1 provides some approximate example values ​​of delivery torque (for example with an 8.65 inner diameter reservoir with a 27 gram ultra-thin walled delivery needle): By way of example, the delivery torque during drug delivery may range from 30-45 g·cm, and / or 45-70 g·cm, and / or 70-90 g·cm, and / or 90-130 g·cm, and / or 130-200 g·cm, and / or 200-1000 g·cm.

[0048] [Table 1]

[0049] In one embodiment, compromises are possible. For example, for more viscous drugs, a lower pitch drive screw may be used, and / or a higher friction anti-rotation pad may be used with a higher pitch screw, and / or a wider gauge needle may be used. For example, the pitch of the drive screw may be in the range of 3 mm to 1 mm, and / or in the range of 1 mm to 0.8 mm, and / or in the range of 0.8 mm to 0.6 mm, and / or in the range of 0.6 mm to 0.3 mm, and / or in the range of 0.3 mm to 0.2 mm.

[0050] In one embodiment, the friction element is configured to reduce frictional resistance to axial movement of the extruded shaft. By way of example, the normal force between the friction element and the wall of the reservoir can be increased with tangential movement and / or decreased with axial movement. By way of example, the ratio of normal force in tangential movement to normal force in axial movement can be between 1.1 and 4, and / or between 4 and 10, and / or between 10 and 100, and / or greater than 100.

[0051] In one embodiment, the friction elements include directional friction surfaces, such as, for example, micro-nails, and / or embossed surface patterns, and / or biased hairs, and / or nubs, and / or anisotropic molecular structures, and the like.

[0052] In one embodiment, the shaft can advance inwardly and engage the plunger after separation.

[0053] One aspect of an embodiment of the invention relates to a connection of the anti-rotation element. Optionally, a snap connection connects the anti-rotation friction ring to a plunger driver, in one example to a shaft that drives the plunger. By way of example, the snap connection can constrain the movement of the anti-rotation element in one or more directions along one or more of six axes (e.g., linear movement in one or more of three axes and / or rotation about one or more of three axes).

[0054] In one embodiment, the snap connection may include a fastening element. For example, the fastening element may prevent the friction element from moving away from the driver. In one embodiment, the fastening element may be elastic and / or may fit into a complementary elastic element. For example, the fastening element may include an elastic portion of a hard plastic element and / or an elastic element. Optionally, the anti-rotation element component may be an elastomer (such as, for example, rubber and / or a synthetic elastomer). Optionally, the elastic fastening element may be configured inside the elastomer. For example, the friction pad may snap-connect to the mounting portion and / or the plunger driver and / or the shaft. For example, the mounting portion may snap-connect to the plunger driver and / or the shaft.

[0055] In one embodiment, the friction element can be connected to the plunger driver using a threaded connection and / or a frictional connection and / or an internal locking element and / or a fastening element. The friction element can be inhibited from moving relative to the driver in one or more of six linear and / or rotational directions. As an example, the friction element can secure the driver to the reservoir when the assembly is in the syringe device and / or during storage and / or shipping. Optionally, the friction element can include an anti-rotation element. As an example, the anti-rotation element can inhibit rotation of the driver relative to the reservoir and / or allow linear movement relative to the reservoir. In one example, the linear movement can be driven by a threaded driver.

[0056] In one embodiment, the anti-rotation element can be prevented from rotating relative to the reservoir by friction between the element and an inner wall of the reservoir. In one embodiment, the anti-rotation element can be prevented from rotating relative to the plunger seal by friction between the element and the plunger seal. In one embodiment, the plunger seal can be prevented from rotating relative to the reservoir by friction between the plunger seal and an inner wall of the reservoir.

[0057] One aspect of the present invention relates to an interface between the plunger driver and the plunger seal of the drug reservoir. For example, the plunger driver may have a surface that abuts against a surface of the plunger seal. For example, a distal surface of the driver may press against a proximal surface of the plunger seal. Optionally, a friction force, for example between surfaces that contact each other, may inhibit rotation of the driver relative to the plunger seal. For example, an anti-rotation friction element of the driver may abut against the plunger seal and / or the mounting portion. Optionally, the friction element and / or the plunger seal may be made of an elastomer. In one embodiment, a surface and / or a portion of the plunger seal is coated with a friction-enhancing compound, for example (e.g., an elastomer and / or a rough surface) and / or a friction-attenuating compound (such as polytetrafluoroethylene (PTFE)). Alternatively, or in addition, the driver can engage the plunger seal using a threaded connection and / or an internal locking mechanism element and / or a fastening element.

[0058] One aspect of an embodiment of the invention relates to a friction element that holds the plunger driver in the drug reservoir, optionally inhibiting the driver from separating from the reservoir due to frictional forces between the friction element and an interior surface of the reservoir.

[0059] One aspect of an embodiment of the invention relates to a vent in the friction element and / or driver. By way of example, the vent allows fluid to escape and / or enter the reservoir as the driver enters and / or exits the reservoir. The vent is optionally formed in the friction element and / or between the friction element and the wall of the reservoir and / or between the friction element and the mounting and / or inside the mounting. [Detailed embodiment] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited to the details of construction and the arrangement of components and / or methods set forth below and / or illustrated in the drawings, as the invention is capable of other embodiments or of being practiced or carried out in various ways.

[0060] FIG. 1 is a flow chart illustrating a method for facilitating movement of a pusher shaft of a plunger according to an embodiment of the present invention. In one embodiment, a friction element prevents the pusher shaft from rotating, for example, relative to a reservoir, thereby facilitating relative rotation between the pusher shaft and a drive element. Optionally, the pusher shaft always starts to rotate in the constrained direction, so that the friction force between the pusher shaft and the reservoir increases. In one embodiment, the friction force decreases as the pusher shaft advances. For example, the reduced friction force may reduce the load on the drive system when pushing the plunger and / or expelling a drug.

[0061] In one embodiment, a fixed medication reservoir is provided at step 102. By way of example, the reservoir may have a cylindrical cavity with a distal opening and / or a proximal opening. A plunger is optionally inserted into the cylindrical cavity. By way of example, the plunger may divide between a distal portion of the medication-containing cavity and a proximal portion of the cavity.

[0062] In one embodiment, in step 104, a distal portion of the nested plunger pusher assembly can be inserted into the proximal opening of the reservoir. By way of example, the distal portion of the nested plunger pusher assembly can include an extrusion shaft and / or a distal portion of the extrusion shaft, a plunger interface, and / or a friction element. Optionally, the plunger interface of the extrusion assembly positively engages the plunger when the assembly is inserted in step 104. Alternatively, or in addition, the plunger interface can be disengaged from the plunger when the assembly is inserted into the reservoir in step 104. In one embodiment, the distal end of the extrusion assembly can be inserted in step 104 until it contacts the plunger. Alternatively, or in addition, after insertion in step 104, the distal end of the extrusion assembly can be spaced proximally away from the plunger.

[0063] In one embodiment, the friction surface can be held in contact with the inner wall of the reservoir and / or the extrusion shaft in step 106. By way of example, the radial form element can maintain at least a minimum normal force between the friction surface and the inner wall of the reservoir when the system is stationary. By way of example, the radial form element can be flexible and / or resiliently compressible.

[0064] In one embodiment, the drive element is rotatable in a first direction in step 108. Optionally, the drive element is engageable with the extrusion shaft. By way of example, rotation of the drive element in step 108 allows the extrusion shaft to move in step 110. By way of example, the extrusion shaft may tend to rotate along the drive element in the first direction in step 112. In one embodiment, it may be desirable to constrain the rotation of the extrusion shaft in step 112. By way of example, if the nest is driven by relative rotation between the drive element and the extrusion shaft, rotation of the extrusion shaft along the drive element in step 112 may be undesirable. Optionally, the friction element may be configured such that rotation of the extrusion shaft in the first direction in step 112 allows the friction element between the extrusion shaft and the wall of the reservoir and / or the radial shaped element to be tightened in step 114. Tightening of the friction element between the drive shaft and the non-rotating reservoir in step 114 optionally increases the normal force between the friction element and the wall of the reservoir and / or increases the friction force between the drive shaft and the reservoir and / or inhibits rotation of the extrusion shaft in step 112 in step 115.

[0065] In one embodiment, a set of threads allows engagement between the drive element and the extruder shaft. For example, rotation of the drive element in a first direction relative to the extruder shaft in step 108 allows advancement of the extruder shaft distally into the reservoir in step 116. For example, advancement in step 116 allows the extruder shaft to approach the plunger and / or the abutment to engage the plunger and / or advance distally of the plunger. Optionally, advancement of the extruder shaft in step 116 allows the friction element and / or radial shaped element to release a clamped element, such as the friction element and / or radial shaped element, in step 118. Release of the clamped element in step 118 optionally reduces a normal force between the friction element and a wall of the reservoir and / or reduces a frictional force between the drive shaft and the reservoir and / or facilitates advancement of the extruder shaft.

[0066] FIG. 2 is a flow chart illustrating a method of a plunger driver according to an embodiment of the present invention. Optionally, the plunger is driven by advancing the extruded shaft. By way of example, the advancing of the extruded shaft may result from a relative rotation of the drive element with respect to the extruded shaft. A tangential frictional force between the frictional element and the reservoir may provide a counter-rotational torque between the extruded shaft and the reservoir, facilitating the relative rotation between the extruded shaft and the drive element. In one embodiment, the extruded shaft may advance in the reservoir upon separation from the plunger. Optionally, when the extruded shaft and the plunger are separated, the tangential frictional force between the frictional element and the reservoir is sufficient to substantially prevent the extruded shaft from rotating along the rotating element. In one embodiment, the frictional element may be configured to provide increased resistance to undesired movement (by way of example rotating with the drive element) and / or reduced resistance to desired movement (by way of example advancing the plunger).

[0067] In one embodiment, a distal portion of the plunger extrusion assembly can be inserted into a proximal opening of the drug reservoir at step 104. Optionally, the drug reservoir is rotationally immobile. Optionally, the drug reservoir includes a plunger that provides separation between the drug in the distal portion of the reservoir and an opening in the proximal portion of the reservoir. Optionally, after insertion, a plunger interface of the extrusion assembly can be spaced proximally from the plunger. Optionally, the plunger interface is attached to a distal portion of the extrusion shaft.

[0068] In one embodiment, after the distal end of the plunger drive assembly is inserted into the reservoir in step 104, the drive element may be engaged with a power source in step 207. By way of example, the power source may include an electric motor. The power source optionally rotates the drive element in a first direction in step 108.

[0069] In one embodiment, rotation of the extruded shaft can be frictionally constrained by frictional forces between the friction element and an inner wall of the reservoir while the drive element rotates in a first direction in step 108. Optionally, rotation of the drive element in a first direction relative to the extruded shaft in step 108 can cause the extruded shaft to telescope and / or move distally relative to the drive element. By way of example, the extruded shaft and plunger interface can be advanced apart until it reaches the plunger.

[0070] In one embodiment, the plunger interface may be engageable with the plunger. By way of example, the plunger interface may transmit axial forces between the plunger and the extruded shaft. In one embodiment, the plunger interface may limit rotation between the plunger and the extruded shaft. By way of example, after engagement with the plunger, frictional forces between the plunger and the inner wall of the reservoir may prevent rotation of the extruded shaft in addition to and / or instead of the frictional element. Alternatively or additionally, the plunger interface may allow rotation of the extruded shaft relative to the plunger. Optionally, allowing rotation of the extruded shaft relative to the plunger may reduce rotational forces on the plunger.

[0071] According to one embodiment, as the extrusion shaft advances and / or the plunger interface engages the plunger, the frictional force between the friction element and the wall of the reservoir is reduced, step 218. The reduced frictional force facilitates advancement of the plunger driver, step 216, and / or advancement of the plunger, step 234.

[0072] <Anti-rotation system block diagram> 3A is a block diagram of an assembly for driving a drug reservoir and a plunger according to an embodiment of the present invention. By way of example, the plunger drive assembly may include a telescopic assembly including a variable friction force assembly 330, and / or a proximal element 320, and / or a distal shaft 322, and / or a plunger interface 332. The telescopic assembly optionally telescopically extends and retracts via rotation of the proximal element 320 (e.g., a drive element) relative to the distal shaft 322 (e.g., a plunger extrusion shaft). By way of example, the proximal element 320 is rotatable relative to the drug reservoir 324 and / or the distal element 322 is prevented from rotating relative to the drug reservoir 324. Optionally, the distal element 322 is prevented from rotating by friction forces with the walls of the reservoir 324. By way of example, the friction forces with the walls of the drug reservoir 324 are generated by the variable friction assembly 330. By way of example, the variable friction assembly 330 may have high resistance to rotational and tangential movement relative to the drug reservoir, and / or low resistance to axial translational movement relative to the drug reservoir. Optionally, a motor 321 rotates the proximal element 320 relative to the reservoir.

[0073] In one embodiment, the variable friction assembly 330 comprises a radial shape element 352 and / or a friction surface 331. Optionally, the radial shape element 352 couples the friction surface 331 to the distal shaft 332. Optionally, the radial shape element 352 maintains the friction surface 331 in contact with the inner wall 324 of the reservoir.

[0074] In one embodiment, the radial shape element 352 maintains a variable normal force between the friction surface 331 and the inner wall 324 of the reservoir. By way of example, the radial shape element 352 may be clamped between the inner wall 324 of the reservoir and the shaft 322 such that tangential movement of the friction surface 331 in at least one direction can compress the radial shape element (optionally increasing the normal force). Alternatively or additionally, the radial shape element 352 may be clamped between the inner wall 324 of the reservoir and the shaft 322 such that axial movement of the friction surface 331 in a distal direction can release the compression of the radial shape element (optionally increasing the normal force). By way of example, the radial shape element may include one or more of a sprag, a virtual sprag, a beam with a desired curvature orientation, a dog clutch, a wedge, a strut, and / or a virtual beam with a desired curvature orientation.

[0075] In one embodiment, the radial shaped elements 352 can be tightened by movement in any of a number of directions. As an example, the radial shaped elements 352 can include trapezoidal sprags that are tightened on one side by movement in one direction and tightened on the other side by movement in the opposite direction. Alternatively or additionally, the friction force assembly 330 can include multiple anisotropic sprags and / or beams oriented in various directions to increase frictional force in one or more directions. As an example, the friction force assembly 330 can increase rotational frictional resistance force about a rotational direction and / or reduce frictional force of linear movement in one or more directions.

[0076] In one embodiment, the friction surface 331 may have an anisotropic coefficient of friction. By way of example, the coefficient of friction may be high in a single tangential direction, optionally resulting in high frictional resistance to rotation of the extruded shaft at the distal end relative to the reservoir and / or low frictional resistance to distal movement relative to the drug reservoir in at least one direction. Alternatively or additionally, the friction surface may have an anisotropic coefficient of friction.

[0077] In one embodiment, the proximal element 320 may be partially inserted and / or fully inserted adjacent to the proximal opening reservoir 324. In one embodiment, the distal shaft 322 may be partially inserted and / or fully inserted adjacent to the proximal opening reservoir 324.

[0078] In one embodiment, the reservoir 324 may contain a fluid, such as a drug. By way of example, the drug can be disposed in a distal portion of the reservoir 324. Optionally, a plunger seal 326 can seal and / or isolate the drug 328 from a proximal opening of the reservoir and / or the plunger pusher assembly.

[0079] In one embodiment, when the plunger interface 332 engages the plunger seal 326, it can provide a one-way, two-way, or multi-dimensional connection between the extruded shaft 322 and the plunger seal. By way of example, the plunger interface 332 can include a ram that provides a compressive force between the shaft 322 and the plunger seal 326 to push the plunger distally, while providing low and / or negligible tensile force to push the plunger seal 326 proximally. The ram can have a friction surface with the plunger and / or be partially pushable within the plunger. Alternatively, the plunger interface 332 can provide a snap, screw, or compressive force between the shaft 322 and the plunger seal 326 to push the plunger distally, and the interface element can provide a tensile force to push the plunger seal 326 proximally. In one embodiment, the interface 332 transfers torque between the plunger seal 326 and the shaft 322. Alternatively, and additionally, the interface 332 may not transmit large torque forces, for example the interface 332 may include an axis of rotation that allows the shaft 322 to rotate the plunger seal portion 326 independently.

[0080] FIG. 3B is a schematic diagram of a sprag 353 according to an embodiment of the present invention. By way of example, in FIG. 3B and FIG. 3C, the sprag 353 is in contact with a surface 325. As an example, as shown in FIG. 3B, the surface 325 moves in a constrained direction indicated by arrow 388. Optionally, the surface 325 travels opposite to the constrained direction, ensuring that the angle of attack between the sprag 353 and the direction of movement is less than 90 degrees. By way of example, the angle of attack may be in the range of 89-85 degrees, and / or in the range of 85-70 degrees, and / or in the range of 70-45 degrees, and / or in the range of 45-0 degrees. Optionally, in one embodiment, the sprag is anisotropic. By way of example, the angle of attack may be different on the leading and / or trailing ends. Movement of surface 325 can optionally generate a rotational moment 384 on sprag 353 and / or clamp sprag 353 between shaft outer wall 323 and surface 325. If movement is in a constrained direction, rotational moment 384 and / or clamping optionally increases normal force 382 of sprag 353 against surface 325. In one embodiment, if movement is in a constrained direction, rotational moment 384 and / or clamping optionally increases frictional force 383 of sprag 353 against surface 325.

[0081] FIG. 3C is a schematic diagram of a sprag 353 according to an embodiment of the present invention. In one example, the surface 325 moves in a direction opposite to the restrained direction, as indicated by arrow 388′ in FIG. 3C. Optionally, as the surface 325 moves in a direction opposite to the restrained direction, an angle of attack 386′ between the sprag 353 and the direction of movement is ensured to be greater than 90 degrees. By way of example, the angle of attack may be in the range of 91-95 degrees, and / or in the range of 95-120 degrees, and / or in the range of 120-135 degrees, and / or in the range of 135-180 degrees. The movement of the surface 325 optionally generates a rotational moment 384′ on the sprag 353 and / or releases the clamping of the sprag 353 between the outer shaft wall 323 and the surface 325. When moving in a direction opposite to the restrained direction, the rotational moment 384' and / or the release of the clamping force may reduce the frictional force 383' of the sprags 353 against the surface 325.

[0082] 4A, 4B, 4C, 4D, and 4F are diagrams of a drug reservoir having a plunger drive assembly and a threaded plunger interface in accordance with the present invention. In one embodiment, a variable anti-rotation friction element 430 of multiple sprag arms can provide rotational resistance to the extruder shaft (see, for example, extruder shaft 422 in FIG. 4B). The anti-rotation friction facilitates relative rotation and / or telescoping of the extruder shaft with respect to a driver (for example, driver 420). For example, extruder shaft 422 can be threaded with a screw, and driver 420 can include a threaded member, such as a threaded shaft or a nut.

[0083] 4A illustrates a plunger drive assembly according to the present invention initially inserted into a proximal opening of a drug reservoir 424. In one embodiment, a distal portion of the plunger drive assembly illustratively includes a plunger interface 432. Illustratively, interface 432 fits and / or threadably couples into a cavity in plunger seal 426. Additionally or alternatively, the drive assembly may include a variable resistance friction element 430 and / or a distal portion of extruded shaft 422. Optionally, plunger interface 432 is distally disposed and / or separated from plunger seal 426 when the plunger drive assembly is inserted.

[0084] In one embodiment, the transmission device 444, the driver 420, the needle retraction lock 446 and a portion of the proximal shaft 422 are disposed externally and / or proximally relative to the reservoir 424. Optionally, a distal portion of the reservoir 424 includes a distal opening and a needle attachment portion 442. The distal opening is optionally connected to a hypodermic needle 436. Optionally, the distal portion of the reservoir 424 is filled with a medicament 228. A plunger seal 426 separates and / or seals the reservoir 424 between the medicament 228 and the proximal portion of the reservoir 424 and / or the proximal opening.

[0085] In one embodiment, the drug cartridge may include an indicator. Optionally, the indicator may include a portion of the plunger seal 426 or the plunger drive assembly. Optionally, the indicator may be, for example, clear, tinted, and / or translucent so that the user can see through a portion of the reservoir wall. By way of example, the friction element 430 may indicate the position and / or movement of the plunger drive assembly to the user. The plunger interface 432 may indicate when the drive assembly begins to push against the plunger seal 426 (e.g., the start of delivery). By way of example, the interface element 432 may be a different color than the plunger seal 426 and / or the friction pad 430. By way of example, the interface element 432 may be blue or red, as may the plunger seal 426 and / or the friction pad. If the element 432 is not inserted into the cavity 435, the user may see the red, indicating that delivery has not yet begun. Alternatively or additionally, the indicator may include a portion that fits within cavity 432 when the driver contacts the seal but does not engage plunger seal 426.

[0086] 4B is a diagram of a plunger drive assembly with the nested assembly beginning to open advancing the plunger interface 432 towards the plunger seal 426, according to one embodiment of the invention. In one embodiment, after insertion, the nested assembly can extend to advance the interface 432 towards and / or engage the plunger seal 426.

[0087] In one embodiment, the abutment 432 is advanced by rotating the transmission portion 444 and / or the retraction lock portion 446 and / or the driver 420 relative to the reservoir 424. The driver 420 is optionally threadably engaged with the extruded shaft 422. In one embodiment, friction between the friction element 430 and the inner wall of the reservoir 424 inhibits rotation of the extruded shaft 422 and allows the rotation driver 420 to rotate relatively between the driver 420 and the extruded shaft 422. Relative rotation of the driver 420 and the extruded shaft 422 optionally advances the extruded shaft 422 and / or the abutment 432 towards the plunger seal portion 426.

[0088] In one embodiment, the junction 432 advances until it contacts the plunger seal 426. When the junction 432 contacts the plunger seal 426, the junction 432 is linearly coupled to the plunger seal 426 (e.g., such that further linear advancement of the junction 432 can advance the plunger seal 426) and can rotate independently of the plunger seal 426 (e.g., such that rotation of the junction 432 does not rotate the plunger seal 426). In one embodiment, distal advancement is optionally stopped by a normal force between the junction 432 and the plunger seal 426, and / or a frictional force between the plunger seal 426 and the wall of the reservoir 424, and / or a normal force between the drug 228 and the plunger seal 426. Optionally, while the interface 432 is not advanced, the rotational movement of the driver 420 can overcome the frictional forces between the friction element 430 and the wall of the reservoir 424 and / or rotate the interface 432. As an example, the interface 432 can be threaded into the plunger seal 426.

[0089] In one embodiment, the interface 432 is fully threaded into the plunger seal 426, and the interface 432 is rotationally connected to the plunger seal 426 (e.g., such that further rotation of the interface 432 rotates the plunger seal 426). In one embodiment, the rotation of the interface 432 is optionally stopped due to the combined rotational frictional resistance of the interface 432 and the plunger seal 426 against the wall of the reservoir 424. While the interface 432 does not rotate, optionally, the rotation of the driver 420 overcomes the axial movement resistance and / or the plunger seal 426 begins to move axially and / or begins ejecting the drug from the distal opening of the reservoir (e.g., via the needle 436). In one embodiment, the reservoir 424 may include a flange 438. By way of example, the flange 438 may extend out from the rear of the reservoir 424.

[0090] 4C is an enlarged view of a perspective view of a distal end of an extruded shaft including a plunger interface 432 and a friction element 430, according to an embodiment of the present invention. In one embodiment, the anti-rotation assembly may include an air vent 450. By way of example, the air vent 450 may allow air to escape from the area between the plunger seal 426 and the interface 432, such as when the interface 432 approaches the plunger seal 426.

[0091] In one embodiment, the positioning base 440 can limit the proximal movement of the friction element 430 and / or determine the axial relationship of the junction 432 and / or the shaft 422 to the friction element 430 and / or straighten the warping and / or buckling of the radial shape element 452. By way of example, the base 440 can prevent the radial shape element 452 from buckling proximally and / or separating from the wall of the reservoir 424. Optionally, the friction element 431 is at least on the outer end of the radial shape element 452. By way of example, the friction element 431 can be held in contact with the inner wall of the reservoir.

[0092] 4D is a perspective view of a friction element 430 according to an embodiment of the invention. By way of example, element 430 is a disk-shaped element with separate flexible radially shaped elements 452, such as sprags. Optionally, each sprag includes a friction surface 431 that contacts the wall of reservoir 424. By way of example, each sprag is radially inclined in the direction of constrained movement. Optionally, friction surface 431 is on the outer end of each radially shaped element 452. By way of example, the outer end of each radially shaped element 452 may be outwardly radiating and / or the outer end (head 453) of each sprag may be wider than the central end (stem 455).

[0093] In one embodiment, the radial shape element 452 is inclined with respect to the direction of rotation restraint. As an example, the direction of rotation restraint may be the direction of rotation of the driver 420 for expanding the nested assembly. Optionally, when the driver 420 rotates (and / or advances the extrusion shaft 422) in a direction for expanding the nested assembly and the friction element 430 starts to rotate in the direction of the driver 420 rotation, the sprag-type radial shape element 452 is clamped against the wall of the reservoir 424. Optionally, when the driver 420 rotates in a direction for expanding the nested assembly and the friction element 430 starts to rotate in the direction of the driver 420 rotation, the friction force increases between the friction element and the reservoir 424, which restrains the rotation of the shaft 422 and / or facilitates the relative rotation between the driver 420 and the shaft 422 and / or facilitates the advancement of the shaft 422. In one embodiment, the sprag 452 may be anisotropic. As an example, the angle of attack of the leading end 456a may be greater than the angle of attack of the trailing end 456b. As an example, the average angle of attack of the sprags 452 may be between the range of 80-90 degrees and the average difference in angle between the leading end 456a and the trailing end 456b may be between the range of 1-9 degrees. As an example, the average angle of attack of the sprags may be between the range of 60-80 degrees and the difference in angle between the leading end and the trailing end may be between the range of 1-40 degrees. As an example, the average angle of attack of the sprags may be between the range of 20-60 degrees and the difference in angle between the leading end and the trailing end may be between the range of 1-70 degrees.

[0094] In one embodiment, the friction element 430 is rubber, elastomer, and / or has a Shore OO hardness of about 50. By way of example, the hardness is 10-30 Shore OO, and / or 40-60, and / or 60-100 Shore A, and / or 60-100 Shore A. Optionally, the unloaded diameter of the friction element 430 is slightly larger than the inner diameter of the reservoir 424. By way of example, the unloaded outer diameter of the element 430 may be about 9.1 mm, while the inner diameter of the reservoir 424 may be about 8.65 mm. Optionally, the inner diameter of the reservoir may be in the range of 1-4 mm, and / or 4-7 mm, and / or 7-10 mm, and / or 10-15 mm, and / or 15-30 mm. Optionally, the outer diameter of the friction element may be in the range of 100%-103%, and / or 103%-107%, and / or 107%-120%, and / or 120%-150% of the inner diameter of the reservoir. In one embodiment, the friction element 430 may have a closed diameter of the base of the sprags 452 of about 6.3 mm, and / or a length (radial) of the sprags 452 of about 1.4 mm. By way of example, the thickness (along the length of the reservoir 424) of the element 430 and / or the sprags 452 may have a radial length of the head of the sprags 452 of about 1.65 mm, and / or the area of ​​the surface 431 of each sprag 452 abutting the inner wall of the reservoir 452 may be about 2+1.65=3.3 mm2. In one embodiment, the length of the sprag elements may be between 1-10%, and / or between 10-20%, and / or between 20-40%, and / or between 40-70%, and / or between 70-100% of the diameter of the reservoir. In one embodiment, the width of the friction element may be between 5-15%, and / or between 15-25%, and / or between 25-50%, and / or between 50-75%, and / or between 75-150%, and / or between 150-600% of the diameter of the friction element.

[0095] In one embodiment, the friction element 430 may include a mounting portion for connecting to the extruded shaft 422 and / or the junction 432. As an example, the shaft mounting portion 454 of the friction element 430 includes a female threaded opening that threadably mates with the male threads 462 of the plunger junction 432 (see, for example, FIG. 4E ).

[0096] 4E is a close-up perspective view of plunger interface 432, according to an embodiment of the present invention. By way of example, interface 432 is a rigid element with a tapered thread 462 for attachment to optional plunger seal 426 and / or friction element 430. Optionally, interface 432 includes a tapered distal surface 466 and / or proximal base 440 and / or vent 450. Optionally, vent 450 includes a slit in base 440. Optionally, slit 450 is positionable in the space between radial shaped elements 452. Alternatively or additionally, the friction element may include a vent. By way of example, a friction element is attached to interface 432, and the vent in the friction element is positionable together with vent 450.

[0097] In one embodiment, the friction element 430 may include a mounting for connecting to the extruded shaft 422 and / or the junction 432 .

[0098] As an example, the shaft mounting portion 454 of the friction element 430 may include a female-threaded opening that threadably engages with the male threads 462 of the plunger interface 432 (see, for example, FIG. 4E).

[0099] 4F is a cross-sectional view of friction element 430 attached to adapter 432, according to an embodiment of the present invention. Illustratively, male threads 462 are smaller at the insertion point (distal end) and larger moving proximally. The rear (proximal) surface of the tooth is optionally at a more acute angle (e.g., 70-95 degrees from the axis of adapter 432) than the front (distal) surface of the tooth (e.g., ranging between 115-145 degrees from the axis of adapter 432).

[0100] 5 is a perspective view of a plunger pusher rod and friction element to facilitate translational movement, according to an embodiment of the invention. Optionally, friction element 530 is angled backwards (e.g., proximally). By way of example, the angle of attack of element 530 with respect to the advancement of shaft 422 may be 90 degrees or more. Optionally, shaft advancement reduces normal forces and / or frictional forces between friction element 530 and the reservoir wall. Optionally, when the shaft rotates but does not advance, the frictional forces between element 530 and the reservoir are high, inhibiting rotation. Optionally, as shaft 422 advances through reservoir 424, the shape of element 530 reduces frictional forces and facilitates advancement.

[0101] <Friction disc with anti-rotation beam> FIG. 6A is a cross-sectional view of a plunger pusher rod including a flexible beam anisotropic friction element according to an embodiment of the present invention. In one embodiment, the friction element 630 may include an anisotropic curved beam 652. For example, when the beam 652 bends in a constrained direction, it cannot bend out and / or is pinched between the plunger junction 632 and the wall of the reservoir 424. For example, when the beam 652 bends in an unconstrained direction, it can bend out of the way and / or reduce frictional forces. In FIG. 6A, the element 652 is illustrated when it is relatively unstressed.

[0102] In one embodiment, the beams may have anisotropic compressibility and / or elasticity. As an example, beam 652 has a notch 672. The side of the beam with the notch stretches and / or compresses more easily than the opposite side.

[0103] 6B illustrates a stressed state due to rotation of junction 632 in a constrained direction 678, according to one embodiment of the invention. Optionally, when element 652 is loaded, notches 672 tend to expand and / or contract, while the unnotched side of the beam tends to buckle and / or bow. Optionally, rotation in the constrained direction 678 causes notches 672 to open fixed surface 631 to reservoir 424, increasing normal and / or frictional forces between surface 631 and reservoir 424.

[0104] 7A and 7B are side views of a plunger pusher assembly with reduced friction when engaged with a plunger, according to an embodiment of the present invention. By way of example, friction element 730 can be sized to contact a wall of a drug reservoir and / or create a frictional force with the wall that inhibits rotation of plunger pusher shaft 422 and / or plunger junction 732. Optionally, friction between element 730 and the reservoir and / or resistance to forward movement of the plunger can be reduced when junction 732 engages plunger 726.

[0105] 7A illustrates a plunger interface 732 and friction element 730 separated from the plunger, according to one embodiment of the present invention. In one embodiment, rotation of the driver relative to the shaft 422 allows the shaft 422 to advance along the reservoir. As the interface 732 approaches the plunger 726, the friction element contacts the inner wall of the reservoir 424 and / or inhibits rotation of the shaft 422 and / or facilitates rotation of the driver relative to the shaft 422.

[0106] 7B illustrates a plunger interface 732 and a friction element 730 when engaged with a plunger in one embodiment of the present invention. In one embodiment, when the interface 732 engages the plunger 726, the element (e.g., a hard sidewall and / or a dished and / or annular projection of the plunger) deforms the friction element 730. The deformation of the friction element 730 optionally reduces and / or substantially eliminates the contact surface between the friction element and the reservoir 424. By way of example, the deformation of the friction element 730 can reduce and / or substantially eliminate the friction force between the element 730 and the reservoir 424. Optionally, when the plunger interface 732 engages the plunger 726, the friction force between the plunger 726 and the reservoir 424 can inhibit rotation of the shaft 422 and / or facilitate advancement of the shaft 422 and / or the plunger 726. In one embodiment, the load on the plunger extrusion assembly can be reduced due to a reduction in frictional force between element 730 and reservoir 424. By way of example, interface 732 may engage plunger 726 when the device expels a drug. The reduction in frictional force between element 732 and reservoir 424 optionally reduces the load on the plunger extrusion system when expelling a drug.

[0107] In one embodiment, advancement of the plunger pusher assembly may proceed through several friction steps and / or configurations. By way of example, if the interface 732 is spaced proximal to the plunger 726, the rotational resistance created between the element 730 and the reservoir 424 may be sufficient to prevent rotation of the shaft 422. Rotation of the driver may cause relative rotation between the driver and the shaft 422 and / or advancement of the shaft 422 without the shaft 422 rotating.

[0108] In one embodiment, the shaft 422 advances until the junction 732 contacts the proximal side of the plunger 726. Once the junction 732 contacts the proximal side of the plunger 726, the resistance to rotation by the driver and friction element 730 may be sufficient to overcome the resistance to advancement of the plunger 726. As a result, the junction 732 drives forward, driving the plunger 726 forward and expelling the medicinal product. Alternatively, or additionally, when the junction 732 contacts the proximal side of the plunger 726, the resistance to advancement of the plunger 726 may be sufficient to stop the advancement of the shaft 422. The torque optionally exceeds the resistance to rotation of the element 730 as the resistance of the plunger 726 prevents the advancement of the junction 732. By way of example, abutment 732 may rotate and / or threadably engage within the proximal end of plunger 726 by overcoming a resistance to rotation.

[0109] In one embodiment, once the interface 732 engages the interface on the plunger, it can prevent rotation of the interface relative to the plunger 726. Friction between the plunger 726 and the reservoir 424 can prevent further rotation of the shaft 422, facilitating relative rotation of the shaft 422. Preventing rotation of the interface 732 can optionally facilitate rotation of the driver relative to the shaft 422, optionally facilitating further advancement of the plunger seal 426. <Plunger connection point> FIG. 8 is a perspective view of a plunger pusher rod including a sprag friction element and a ram plunger interface, according to an embodiment of the present invention. In one embodiment, the plunger interface can reliably transmit linear forces between the plunger and the pusher shaft 422. Optionally, the interface can reliably transmit limited or little rotational torque between the plunger and the pusher rod. By way of example, the ram 832 can push the plunger along the axis of the drug reservoir (e.g., distally). The ram 832 can transmit little or no torque about the axis. By way of example, in an embodiment, the ram 832 is not rotationally fixed relative to the shaft 422 and / or the plunger. Torque is optionally transmitted between the shaft 422 and the plunger by frictional forces. Alternatively or additionally, there may be a rotational element (e.g., a rotating shaft and / or a drive shaft) that limits the transmission of torque between the shaft 422 and the ram 832. Optionally, the rotational resistance of the friction element 830 is ensured to be large enough to prevent rotation of the shaft 422 by the driver under the linear resistance of the two loads of the friction element 830 and the plunger (resistance to linear movement of the plunger can be, for example, a friction force between the plunger and the reservoir and / or a resistance force to expelling the drug).

[0110] <Friction disc with anti-rotation sprag ribs> FIG. 9 is a perspective view of a friction element 930 including a substantially sprag friction element according to an embodiment of the invention. In one embodiment, the radial shaped element 952 can be composed of sheets 992 made of inclined layers connected to each other. The sheets 992 are optionally inclined toward the constraining direction of rotation 996. If the periphery of the element 930 is in frictional contact with the stationary reservoir wall, rotation of the element 930 in the constraining direction 996 optionally expands the sheets 992 and / or increases the surface area of ​​friction. Alternatively or additionally, rotation in the constraining direction 996 optionally pushes out a joint 994 that is a substantially sprag element that is stiffer than the sheets, for example increasing the normal force between the friction element 930 and the reservoir wall. Alternatively or additionally, the substantially sprag element can include thickened ribs inclined toward the constrained direction and / or ribs made of a stiffer material than the rest of the disk inclined toward the constrained direction of movement. Optionally, the friction element 930 optionally includes a shaft mounting portion 954 .

[0111] Friction element with rollers 10A is a perspective view of a friction element 1030a including a rolling element 1051 according to an embodiment of the present invention. The rolling element 1051 can rotate for movement in a desired direction and move with minimal friction for movement in an undesired direction. By way of example, the friction element 1030a can move axially within the reservoir 424 with a friction force that is 100 times less than the force required to rotate the element 1030a about the axis of the reservoir 1024. By way of example, the rolling element can be round and / or spherical and / or cylindrical and / or tapered. The rolling element can include wheels and / or drive shafts and / or bearings and / or races and / or cages.

[0112] In one embodiment, the rotating element 1051 may include wheels 1052, as illustrated in FIG. 10B for example. For example, while moving in a desired direction, for example, the element 1030b moves linearly along the axis of the reservoir 424, the wheels 1052 may rotate about the drive shaft 1055. Optionally, the rotating element may be inside a recess and / or a retainer 1091. For example, the retainer 1091 may optionally include a recess for connecting with the element 1089b. For example, the connecting element 1089b may include a disk-like and / or cylindrical connection between the drive screw and / or the plunger adapter. Alternatively or additionally, a friction element may be provided inside the drive element and / or the plunger adapter. For example, the wheels and / or the drive shaft and / or the races and / or the retainer may be provided inside the plunger adapter and / or the drive element.

[0113] In one embodiment of the anti-rotation element 1030b, the connecting element 1089b may include a shaft mounting portion 1054, as illustrated, for example, in FIG. 10C. For example, the connecting element fits between the drive shaft and / or the plunger.

[0114] Friction element to prevent rotation of the reservoir 11 is a perspective view of a drug reservoir with an external anti-rotation friction element, according to one embodiment of the present invention. Optionally, the external friction element 1130 inhibits rotation of the reservoir relative to the housing of the drug delivery device. By way of example, the friction element 1130 has anisotropic friction, with a higher frictional resistance to movement in an undesired direction than in a desired direction. By way of example, the sprags 452 have an increased frictional force that resists rotation of the reservoir 1124 in an undesired direction. Optionally, the reservoir can easily slide longitudinally within the element 1130, but once in place, it is difficult to move in an undesired direction (such as by rotating relative to the sprags 452 and / or removing the reservoir 1124).

[0115] In one embodiment, the elements 1130 can form a ring around the reservoir 1124. Optionally, the sprags 452 radiate inwardly from the ring toward the outer wall of the reservoir 1124.

[0116] In one embodiment, the system may include friction elements in two desired directions. As an example, the friction element 430 may prevent rotation of the plunger drive shaft. As an example, the element 430 may facilitate movement of the plunger driver by the shaft driver 1120. In one embodiment, the sprags 452 of the inner friction element 430 face in a direction opposite to that of the sprags 452 of the outer friction element 1130. As an example, the friction element 430 may apply a first torque in a first undesired direction (undesired with respect to the interior of the element 430) to the inner wall of the reservoir 1124 to prevent the plunger driver from rotating. Optionally, the element 1130 may apply an opposing torque to the outer wall of the reservoir 1124 to prevent rotation of the reservoir 1124. A second torque may inhibit rotation of the reservoir 1124 in a second undesired direction. In one embodiment, the first and second undesired directions may be opposite to each other.

[0117] In one embodiment, the external friction element 1130 may include an anchor portion 1157 for holding the external friction element within the drug delivery device. For example, the anchor portion 1157 may be a protrusion molded into the element 1130 that fits into a recess on an inner wall of a case (such as case 1259 shown in FIG. 12B) of the drug delivery device. Optionally, the anchor portion 1157 inhibits movement of the element 1130 relative to the drug delivery device. Optionally, another method, such as adhesives and / or other portions of anchors and / or fittings, may be used to stabilize the element 1130 relative to the delivery device.

[0118] 12A is a perspective view of a drug reservoir with an alternative external anti-rotational friction element 1230, according to an embodiment of the present invention. Optionally, element 1230 only partially covers reservoir 1124. Optionally, element 1230 is molded in one step with other elements of the drug delivery device. By way of example, element 1230 includes an elastomeric button cover 1257 for the delivery device.

[0119] 12B illustrates the interior of a friction element 1230 attached to the top half of the case 1259 of the drug delivery device. Element 1230 optionally functions to inhibit rotation of the reservoir 1124. Optionally, a cover 1257 may enclose and fluid-seal a cavity in the case 1259. The cavity optionally provides access for a user to press an activation button for the device.

[0120] Optionally, the external friction elements may include various anisotropic friction elements as listed herein above, including, by way of example, sprags, and / or anisotropic curved beams, and / or clutch dogs, and / or substantial elements, and / or anisotropic friction surfaces. Friction to inhibit rotation of the reservoir is optionally provided by multiple elements.

[0121] Example of connecting the driver to a chemical cartridge 13A is a flow chart illustrating a method for retaining a plunger driver in a reservoir according to one embodiment of the present invention. In one embodiment, the plunger driver of the drug delivery cartridge is retained in the drug reservoir by a friction element. By way of example, friction between the friction element and an inner wall of the reservoir can inhibit separation of the driver from the reservoir. Optionally, the friction element includes an anti-rotation friction disk. By way of example, the friction element can hold the cartridge in an assembled state prior to insertion of the cartridge into the delivery device.

[0122] In one embodiment, the drug delivery device is delivered to a drug packaging machine in a pre-assembled state in step 1302. By way of example, the packaging machine fills the reservoirs and performs final assembly of the device in step 1305. Optionally, in step 1305, the filling process is performed under high levels of sterility. In one embodiment, the final assembly is performed under more sterile conditions. In one embodiment, the final assembly has the advantage of simplifying the assembly process and / or avoiding damage to sterile components.

[0123] In one embodiment, the filling step 1305 of the reservoir includes filling the reservoir with a drug, plugging the reservoir, and / or sealing the reservoir. Optionally, the filling step 1305 is performed in a packaging machine and / or a machine that performs automated filling with high sterility. For example, the reservoir can be filled with a metered amount of fluid. Optionally, the fluid is secured to occupy a portion of the reservoir. For example, a payload of fluid can be filled to a distal portion of the reservoir. For example, the plugging step can include inserting a plunger seal (sometimes called a stopper and / or plunger) into the reservoir. For example, the plunger seal can be inserted into a proximal opening of the reservoir. Optionally, the plunger seal is secured until it reaches the proximal end or is adjacent to the proximal end of the payload inside the reservoir. The plugging step is optionally performed under vacuum. Optionally, the stoppering step may include protecting the sterile needle. For example, the needle may be covered with a needle cap.

[0124] In one embodiment, the reservoir is assembled to the drug cartridge at step 1304. For example, after the filling step at step 1305, the packaging equipment can assemble the cartridge at step 1304. For example, at step 1304, assembly includes inserting a distal portion of a plunger driver into a proximal end of the reservoir. In one embodiment, the distal end of the driver can include a friction element. Optionally, the plunger driver is inserted until it engages the plunger seal during assembly. Alternatively, or in addition, contact with the plunger seal can be prevented during assembly of the cartridge at step 1304. For example, the distal end of the driver cannot reach and / or contact and / or fully engage the plunger seal during assembly. In one embodiment, by preventing contact between the driver and the plunger seal, the packaging machine can prevent intricate fit and / or damage to the sterile portion of the plunger seal and / or damage to the payload (e.g., pressure from the driver can damage the payload and / or cause payload leakage). For example, contact can be avoided during assembly of the device and / or subsequent operation, storage, and / or transportation of the device. Optionally, in step 1306, a friction element can hold the driver and reservoir together, for example, during operation of the cartridge and / or assembly of the device.

[0125] 13B is a flow chart illustrating the assembly and / or use of a drug delivery device and / or drug cartridge according to an embodiment of the present invention. Optionally, the plunger seal is maintained separate from the plunger driver during one stage of the assembly process. For example, the plunger driver is maintained separate from the plunger seal while coupled to the cartridge. Optionally, after assembly of the cartridge, the cartridge can be coupled to the remainder of the drug delivery device. Optionally, after coupling the cartridge to the remainder of the device, the plunger driver can engage the plunger seal and / or expel the drug. Alternatively or additionally, the plunger driver can engage the plunger seal prior to fully assembling the device.

[0126] In one embodiment, assembly of the drug delivery device may include step 1307 of attaching the cartridge to the remainder of the device. For example, in a pre-assembled device, the cartridge may be attached to the remainder of the device prior to delivery to the user. For example, the assembly and / or pre-assembly steps including attaching the cartridge to the device may be performed by a drug packaging machine. Alternatively or additionally, the cartridge may be attached to a device provided by a vendor (such as, for example, a pharmacist and / or a medical professional). Alternatively or additionally, the device may be delivered in a state where it is not fully assembled by the user. For example, in step 1307, the user may attach the cartridge to the remainder of the device. For example, in step 1307, the attachment of the cartridge may include connecting a plunger driver to an actuator (such as, for example, a reservoir). For example, a motor may be connected to the driver via a transmission. For example, in step 1307, the attachment of the cartridge may include fixing a portion of the cartridge to the remainder of the device.

[0127] In one embodiment, actuation of the device positively engages the plunger driver with the plunger seal and / or drives the plunger seal into the reservoir, thereby causing ejection of the medication. By way of example, actuation of the device causes the plunger driver to drive the plunger seal against the plunger seal. Optionally, after the plunger seal and / or the friction element contact the plunger seal, the driver drives the plunger seal into the reservoir. Optionally, driving the plunger seal into the reservoir causes ejection of the medication.

[0128] In one embodiment, as the plunger driver advances toward the plunger seal, the area between the plunger driver and the plunger seal is ensured to have a vent formed in step 1350. By way of example, gas interposed between the driver and the plunger seal can be vented through a vent in the driver and / or anti-rotation device. By way of example, gas may need to exit through a proximal opening in the reservoir. The formation of a vent in step 1350 facilitates the driver's access to and / or engagement with the plunger seal.

[0129] 14A illustrates a pharmaceutical cartridge according to an embodiment of the present invention. The cartridge is illustrated in an exemplary assembled state. In one embodiment, the cartridge may include a plunger driver assembly, a reservoir 1424, and a plunger seal 1426. Optionally, the cartridge is pre-assembled and / or sterile and / or sealed.

[0130] In one embodiment, the assembled cartridge may include a plunger drive assembly coupled to the cartridge. Optionally, the plunger drive assembly may be partially and / or completely insertable into the reservoir 1424. By way of example, the plunger drive assembly may include a proximal element 1420. Optionally, the proximal element 1420 is disposed on the exterior and / or proximal portion of the reservoir 1424. Optionally, a distal portion of the plunger drive assembly may be inserted into the reservoir 1424, by way of example, through an opening in the proximal portion of the reservoir. By way of example, friction between the element 1430 and the reservoir 1424 may maintain the connection of the driver assembly to the reservoir 1424. By way of example, the element 1430 is in contact with an inner wall of the reservoir 1424.

[0131] In one embodiment, the cartridge is pre-filled. By way of example, the drug 228 may be loaded into the reservoir 1424. Optionally, the reservoir 1424 may be sealed with a plunger seal. Alternatively, or in addition, the cartridge may be loaded with a placebo, and / or a marker, and / or a dye, and / or a biologically active substance.

[0132] In one embodiment, the friction element 1430 is connected to the proximal element 1420 via the base 1440 and / or the extruded shaft 142 and / or the telescoping shaft 1423. By way of example, the telescoping shaft 1423 may be connected and / or rotatably connected to the proximal element 1420 such that rotation of the proximal element 1420 allows rotation of the telescoping shaft 1423. By way of example, the telescoping shaft 1423 may be threadably connected to the extruded shaft 1422 such that rotation of the telescoping shaft 1423 relative to the extruded shaft 1422 allows the driver assembly to be driven telescopically (e.g., extending and / or retracting).

[0133] In one embodiment, the driver is separate and inserted into the cartridge. For example, in Fig. 14A, the driver is separate from the plunger seal 1426. Optionally, the driver assembly can be separate from the plunger seal 1426 and the cartridge can be stored, transported, and / or attached to the remainder of the drug ejection device. Alternatively, or additionally, the driver assembly can be engaged with the plunger seal 1426 prior to storage, transport, and / or attachment to the remainder of the drug ejection device.

[0134] In one embodiment, the cartridge may include a curved needle mount 1442. By way of example, the needle mount 1442 supports a fluid outlet (such as a hypodermic needle as illustrated in FIG. 14B) at an angle to the longitudinal axis of the reservoir 1424. By way of example, a cartridge with a curved mount 1442 may be used with a patch injector (as illustrated in FIG. 14B, for example). Alternatively or additionally, the cartridge (as illustrated in FIGS. 4A, 4B, and / or 10A, for example) may include a straight needle mount. Alternatively or additionally, the cartridge outlet may include an external fluid pathway and / or a hub to which a septum is attached. Alternatively or additionally, the mount 1442 may include a mounting surface for a sterile needle cap 1437.

[0135] In one embodiment, an indicator may be provided to a drug packaging machine with a drug dispensing device. For example, the reservoir 1424 and / or the plunger drive assembly (including, for example, the friction pad 1430 and / or the extrusion shaft 1422 and / or the base 1440) may include an indicator to a user. Alternatively or additionally, a part provided by the drug packaging machine (for example, the plunger seal 1426 and / or a sticker placed on the reservoir 1424) may include an indicator to a user. For example, the indicator may be provided by the device manufacturer if the indicator indicates a function of the device that is not limited to the packaged drug. For example, the indicator may be provided by the device manufacturer if the indicator indicates an aspect of the process that is specific to the packaged drug.

[0136] 14B illustrates a cartridge coupled to a delivery device, according to one embodiment of the present invention. In one embodiment, the plunger driver may include a telescoping screw assembly (TSA). By way of example, the extruded shaft 1422 may be threadably coupled to a telescoping shaft 1423, which is optionally threadably coupled to an intermediate shaft 1427. Optionally, the assembly telescopingly extends and retracts as the shaft 1423 rotates relative to the extruded shaft 1422.

[0137] In one embodiment, when the cartridge is mated to the remainder of the syringe, the reservoir 1424 is fixed relative to the housing 1482. By way of example, the flange 1438 may be retained by the housing 1482. By way of example, the flange 1438 and / or the reservoir 1424 may include a protrusion attached to the housing 1482 and / or a base portion 1488 of the housing. Alternatively, or in addition, the flange 1438 and / or the reservoir 1424 may include an orientation element (such as a flat surface) that fits over an orientation element on the housing to inhibit rotation of the reservoir 1424 relative to the housing 1482.

[0138] In one embodiment, an actuator (such as a motor) is coupled to a transmission element (such as a gear 1444). Optionally, the actuator rotates the gear 1444 and / or the proximal element 1420, which optionally rotates the telescoping shaft 1423 relative to the housing 1482 and / or the reservoir 1424. Optionally, friction between the friction element 1430 and an inner wall of the reservoir 1424 constrains the rotation of the friction element 1430 relative to the reservoir 1424. Optionally, the extruded shaft 1422 is connected to the friction element 1430, illustratively via a base 1440. Illustratively, the connection constrains the shaft 1422 from rotating relative to the reservoir 1424. Illustratively, allowing the telescoping shaft 1423 to rotate in a direction that expands relative to the reservoir 1424, while immobilizing the extruded shaft 1422 from rotation relative to the reservoir, optionally allows the telescoping assembly to expand longitudinally. Optionally, a hub 1485 in the housing 1482 blocks proximal movement of the telescoping shaft 1423. In one embodiment, it is easier to linearly move the friction element 1430 and / or the plunger seal 1426 distally than to rotate the friction element 1430 relative to the reservoir 1424. By way of example, the pitch of the threads on the TSA may be small enough that large rotations are associated with small linear movements that mechanically dominate the linear movement of the friction pad 1430 over rotation. Expanding the TSA optionally allows distal movement of the extruded shaft 1422 and / or the base 1440 and / or the friction element 1430.

[0139] In one embodiment, the drug ejection device can be provided with a cartridge to be coupled and / or a plunger driver separate from the plunger seal 1426. Optionally, the user places the base 1488 against the user's skin and / or inserts the needle 1436 into the user's skin through an opening 1408 in the base 1488. Optionally, the base 1488 includes an adhesive to attach the device to the skin. The user optionally activates the actuator, driving the pusher shaft and / or the base 1440 and / or the friction element 1430 until they engage the plunger seal 1426. Optionally, the engagement includes a distal surface of the friction pad 1430 contacting a proximal surface of the plunger seal 1426. Optionally, further rotation of the actuator after engagement drives the plunger seal 1426 distally within the reservoir and / or forces the drug 228 out of the needle 1436. <Snap connection for friction elements> 15 illustrates a connection between a friction pad and a plunger driver according to one embodiment of the present invention. In one embodiment, the friction element is connected to the plunger driver by a snap connection. Optionally, a vent is provided to allow for the escape of air as the friction element moves along the reservoir.

[0140] In one embodiment, the friction element may include a snap connection and / or an interference element. As an example, the fastener may be connected to any two components selected from the base, the plunger driver, the friction element, and / or the plunger seal. The connection may include a quick connection, a snap, a recess-fitting protrusion, a barb, or a resilient element. The connection may optionally be designed to be removable by the user and / or permanently connectable. Optionally, the connection may be restrained from movement in one direction and / or multiple directions.

[0141] In one embodiment, the friction pad becomes attached to the plunger driver by one or more connections. By way of example, the friction pad 1430 may include grooves 1554 that fit over the barbs 1563. By way of example, when the pad 1430 fits over the base 1440, the barbs 1563 snap into the grooves 1554 such that a force required to pull the pad 1430 away from the base 1440 is, by way of example, 10 times or more, and / or 100 times or more, and / or 1000 times or more than the force required to connect them together. By way of example, pulling the friction pad 1430 away from the base 1440 may require sufficient force to separate the friction pad 1430.

[0142] In one embodiment, the friction pad is securely attached to the plunger driver by one or more snap connections. As an example, the extruded shaft 1442 is snap-attached into an opening 1550 in the base 1563 and includes one or more resilient arm interference elements 1564. Barbs or hooks in the elements 1564 optionally engage the sides 1550 of the opening that inhibit the base 1440 from being pulled away from the shaft 1422. In one embodiment, the force required to pull the base 1440 from the shaft 1422 may be much greater than the force required to connect them together, for example, 10 times or more, and / or 100 times or more, and / or 1000 times or more than the force of the connection. Optionally, the connection may be permanent. As an example, the force required to pull the base 1440 from the shaft 1422 may be the force required to break the interference element 1564.

[0143] In one embodiment, a friction element can be connected to the plunger driver to provide resistance to movement in any or all directions. For example, the friction pad 1430 (via the base 1440) can be snapped onto the shaft 1422 to provide resistance to movement of the shaft 1422 in all directions with a force significantly greater than the force required to connect the parts. In one embodiment, the friction pad can be utilized during assembly of the driver to the reservoir. For example, friction between the pad 1430 and the inner wall of the reservoir 1424 maintains the connection between the pad 1430 and the reservoir 1424. Optionally, resistance to axial separation between the pad 1430 and the plunger driver maintains the connection between the plunger driver and the reservoir 1424 during assembly of the cartridge and / or delivery device, etc.

[0144] In one embodiment, the friction pad, base, and / or driver may be designed to vent air. For example, venting may occur when the pad is inserted into the reservoir. For example, air trapped between the friction pad and the plunger seal may vent out of the proximal end of the reservoir and / or into the space between the friction pad and the proximal end of the reservoir. For example, there may be space between the friction pad and the proximal end of the reservoir to allow air to vent. For example, the arms and / or sprags 1533 may contact the inner wall of the reservoir 1424. Optionally, vent spaces may be provided between the sprags 1533. Optionally, openings 1550 in the base 1440 may be adjusted to accommodate the spaces between the sprags 1533 such that air passing through the spaces between the sprags may also pass through the openings 1550. Alternatively or additionally, the gas vent may include one or more holes positioned in any desired location. As an example, central hole 1567 a in pad 1430 is aligned with central hole 1567 b in base 1440 which is aligned with central hole 1567 c in telescoping screw 1423 .

[0145] In one embodiment, the friction surfaces can be adjusted to achieve a desired friction force. For example, in one embodiment, the contact surfaces between the plunger seal and the reservoir and / or between the friction pad and the reservoir can be treated to increase and / or decrease friction. In one embodiment, the contact surfaces between the friction pad and the plunger seal may be treated to increase and / or decrease friction. For example, the contact surface 1531 between the friction pad 1430 and the reservoir 1424 may be coated with polytetrafluoroethylene (PTFE) or the like to, for example, decrease friction, while the contact surface 1533 between the friction pad 1430 and the plunger seal 1426 may be coated with a coating having a high friction force (e.g., a roughened coating) and / or may be structured (e.g., with ridges) to increase friction. As an example, the cylindrical side and / or distal surface of plunger seal 1426 may be coated with polytetrafluoroethylene (PTFE), while the proximal surface may comprise an untreated high friction elastomer. The coating of the friction surface may be adjusted depending on the reservoir material. As an example, friction surface 1531 may be coated with polytetrafluoroethylene (PTFE) for use with a plastic reservoir and / or coated with another material, and / or may be uncoated for use with a glass reservoir.

[0146] In one embodiment, the contact area of ​​the friction surface can be adjusted to achieve a desired friction force. As an example, the friction pad 1430 includes four sprags that contact the inner wall of the reservoir 1424 over about 12% of the circumference. As an example, the friction pad 430 may include ten sprags that contact the inner wall of the reservoir 424 over about 70% of the circumference. As an example, the friction pad may contact the inner wall over 1-20%, and / or 20-40%, and / or 40-80%, and / or 80-100% of the circumference. Optionally, the contact surface may be modified to increase the friction force in one direction. As an example, the distal surface may include ridges that increase the friction force between the pad 930 and the plunger seal in one direction compared to another direction, as described, for example, in FIG. 9.

[0147] In one embodiment, the anti-rotation friction pads can generate enough friction to prevent rotation while driving the plunger, in one embodiment, the anti-rotation friction of the friction pads may not be enough to inhibit rotation when driving the plunger, but the total anti-rotation friction between the friction pads and the plunger seal may be sufficient.

[0148] In one embodiment, the contact between the driver and / or the friction pad and the plunger seal can be a flat surface, optionally ensuring that alignment time between the driver and the plunger seal and / or ambiguity in determining the contact location is avoided.

[0149] Example Sizes of Drug Delivery Devices In one embodiment, the payload of the reservoir (e.g., a syringe) may contain, for example, between 0.5-2 ml of drug and / or more. In one embodiment, the syringe can dispense the entire payload as a single dose. The drug delivery device may, for example, be a pen-type syringe and / or an internally powered driver that drives the plunger and / or dispenses the payload. For purposes of this application, the driver of an internally powered syringe may be defined as a drive mechanism that is powered by at least temporarily stored energy within the syringe. The power may be stored in the power source and may, for example, be a chemical potential (such as a gas expanding and / or chemicals forming a battery) and / or a mechanical potential (such as stored in an elastic member and / or a spring and / or a torque spring and / or a pressurized gas). For example, the driver may be designed to dispense the payload over a period of 20-120 seconds and / or 120-600 seconds and / or longer. In one embodiment, the ejection can be driven by a driver. The internally powered driver can be powered by a variety of mechanisms, such as motors (including DC motors, actuators, brushless motors, etc.), and / or transmissions (including telescopic assemblies, and / or threaded members, and / or gears, and / or couplers), and / or elastic mechanisms (such as springs and / or rubber bands), and / or expanding gas, and / or hydraulic actuators.

[0150] A drug delivery device according to an embodiment of the invention may include a reservoir. For example, the reservoir may include a medicine storage container and / or a standard syringe. Optionally, the standard syringe may be preloaded with a medicine using standard equipment and / or a sterile room. The preloaded standard syringe may optionally include a proximal opening. A plunger may optionally seal the proximal opening and / or maintain sterility within the syringe container. A sterile needle (such as a hollow needle) may optionally be connected to the syringe barrel. For example, the hollow portion of the needle may be in fluid communication with the interior of the barrel. The needle may optionally be securely attached to the distal end of the barrel. Sterility of the entire needle and / or part of it may be protected, for example, by a sterile cover. When the syringe is delivered and inserted into the injector, the sterile cover may remain on the needle. By way of example, the medicament container optionally includes a cylindrical body securely attached to a needle. Optionally, the longitudinal axis of the needle and the syringe body may be parallel and / or coaxial. Optionally, the needle may be attached to a distal end of the body. Optionally, the needle tip may indicate the distal direction. In one embodiment, a plunger may slide axially along the inside of the body to expel a payload of medicament. By way of example, the medicament may be expelled via a hollow needle.

[0151] In one embodiment, the force to insert the needle into the patient's skin may range, for example, between 0.02-0.2 N and / or between 0.2-0.5 N. Optionally, the force to inject the drug (for example, the force applied to the syringe plunger) may be between 5-60 N. For example, the force required to inject the drug may depend on the injection rate and / or the velocity of the drug and / or the shape of the syringe and / or the dimensions of the beam.

[0152] For example, upon engagement and / or termination of delivery, the linear force generated by the device may increase to a magnitude of 60N. The needle safety mechanism (e.g., the needle withdrawal structure) may be stress sensitive. For example, the mechanism may include a catch that provides a means to pull the needle back to the withdrawn position with a force of 40N. In one embodiment, the needle protection mechanism may be triggered by a linear force greater than, for example, between 10-60N.

[0153] In one embodiment, the force for injecting the medicament and / or triggering the needle safety may include a torque. For example, the injection of the medicament may be actuated by a plunger. The plunger may optionally be actuated by, for example, threads and / or teeth and / or a threaded assembly such as a telescoping assembly. Optionally, the teeth and / or the pitch of the associated thread may, for example, range between 0.5-2 mm. The diameter of the thread may, for example, range between 3-15 mm. The torque for power injection may, for example, be 0.2-1.0 N·cm. The trigger torque (torque that triggers the needle safety) may, for example, range between 0.5-2 N·cm and / or between 2-4 N·cm and / or between 4-10 N·cm.

[0154] During injection, the linear movement of the plunger may range, for example, between 10-50 mm. The length of plunger movement varies, for example, the volume of medicine injected, which may range, for example, between 0.5-3 ml.

[0155] In one embodiment, the ejection can be torque driven. For example, a driver can apply torque to a threaded member that pushes out a plunger. In one embodiment, the ejection time can depend on the fill volume and / or the viscosity of the fill material. For example, the predicted injection rate can be a viscosity dependent injection rate, for example, for a viscosity in the range of 1 cp-15 cp, the predicted injection rate can be 30-40 sec / 1 ml, for example, for a viscosity in the range of 15 cp-60 cp, the predicted injection rate can be 35-60 sec / 1 ml, and for a viscosity above 60 cp, the predicted injection rate can be in the range of 53-67 sec / 1 ml. The maximum and / or minimum predicted injection time can be, for example, a maximum and / or minimum value that can divide the fill volume by the injection rate. For example, the predicted ejection time may range between 24-48 seconds (for example for volumes in the range between 0.8-1.2 ml with a viscosity in the range between 1-15 cp), and / or between 36-68 seconds (for example for volumes in the range between 1.2-1.7 ml with a viscosity in the range between 1-15 cp), and / or between 51-92 seconds (for example for volumes in the range between 1.7-2.3 ml with a viscosity in the range between 1-15 cp), and / or between 70-150 seconds (for example for volumes in the range between 2.0-2.5 ml with a viscosity in the range between 15-40 cp), and may range between 120 seconds and 3 minutes for larger volumes and / or viscosities.

[0156] In one embodiment, the drug delivery device is configured to be independently operable and / or handheld. By way of example, the device may have a weight ranging between 10 grams and 30 grams, and / or between 30 grams and 150 grams, and / or between 150 grams and 500 grams. Optionally, the drug flow path from the reservoir to the needle may be internal to the device. Optionally, the power source may be internal to the device. Optionally, the device is operable with one hand.

[0157] Since much of the relevant technology accumulated from this application is expected to evolve during the life of the patent, the scope of the term is intended to anticipate all such new technology.

[0158] As used herein, the term "about" refers to ±5%.

[0159] The terms "comprises," "having," "including," "including," "having" and their conjugations mean "including but not limited to."

[0160] The term "consisting of" means "including only".

[0161] The term "consisting essentially of" means that a composition, method, or structure may contain additional components, steps, and / or parts, provided that the additional components do not materially alter the basic and novel properties, method, or structure of the claimed composition.

[0162] As used herein, the indefinite articles "a," "an," and "the" include the plural unless the context clearly indicates the singular. By way of example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0163] Throughout this application, various embodiments of the invention may be expressed in any range format. It should be understood that the description in range format is merely for convenience and simplicity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to have expressly disclosed all possible subranges as well as the individual numerical values ​​within the range. For example, the description of a range from 1 to 6 should be considered to have expressly disclosed the subranges 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, as well as the individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0164] Whenever a numerical range is given herein, it is deemed to include any recited numerical value (fractional or integer) within the given range. The expressions "ranging / ranges between (first given number) and (second given number)" and "ranging / ranges between (first given number) and (second given number)" are used interchangeably herein and are meant to include the first and second given numbers and all fractional and integer numbers therebetween.

[0165] Certain features of the invention are described in the context of separate embodiments for clarity, but may also be provided in combination with the individual embodiments. In contrast, various features of the invention are described in the context of a single embodiment for brevity, but may also be provided separately or in any desired subcombination or separate embodiment of the invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiments do not function properly without those elements.

[0166] While the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will become apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0167] It will be appreciated by those skilled in the art that modifications may be made to the embodiments described above without departing from the broad inventive concept of the invention, and it is therefore understood that the invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the invention as defined in the appended claims.

Claims

1. 1. A method of distributing a pharmaceutical product, comprising: providing a reservoir comprising the drug, a delivery device including a friction element having a groove, a drive element, and a ring and a plurality of flexible radially shaped elements extending from the ring, the reservoir being at least partially covered by the ring; inserting the reservoir longitudinally into the groove such that the friction element covers at least a portion of the reservoir and contacts the reservoir; rotating the drive element in a first rotational direction, thereby fixing the plurality of flexible radial shaped elements between the ring and the reservoir and increasing a frictional resistance to movement of the plurality of flexible radial shaped elements in the first rotational direction relative to a frictional resistance to movement in a second rotational direction, thereby preventing rotation of the reservoir in the first rotational direction.

2. The method of claim 1 , further comprising the step of sliding the reservoir longitudinally over the friction element.

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