Fluid delivery cassette
The fluid delivery cassette addresses the challenges of conventional injection devices by incorporating a retractable needle and a tapered helix mechanism, enabling a compact, portable, and efficient drug delivery system with precise dosing and reduced waste.
Patent Information
- Application Number
- JP2024574543
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-06-22
- Filing Date
- 2023-06-20
- Publication Date
- 2025-07-03
AI Technical Summary
Conventional injection devices are cumbersome for frequent self-administration of drugs, pose challenges in maintaining needle sterility, and are inconvenient for users due to their elongated design, which hinders portability and ease of use.
A fluid delivery cassette with a retractable needle and a drive assembly featuring a tapered helix mechanism that allows for compact design, precise fluid control, and includes a disposable and reusable components for efficient drug delivery.
The cassette provides a convenient, portable, and sterile drug delivery system that ensures accurate dosing and reduces waste by using a compact design with interchangeable components.
Smart Images

Figure 2025520570000001_ABST
Abstract
Description
Technical Field
[0001] The present disclosure generally relates to fluid delivery devices such as injection devices. More specifically, the present disclosure relates to a fluid delivery cassette that includes a retractable needle and a drive assembly for delivering a controlled amount of fluid through the needle.
Background Art
[0002] Conventional injection devices are often used to inject drugs into patients via a needle. In some cases, it may be advantageous for the drug to be administered without a medical professional, such as when the drug is administered frequently (e.g., daily at different times during the day). However, it can be difficult to ensure that the needle is maintained in a sterile environment prior to injection and to guarantee that the drug is administered safely, efficiently, and in the appropriate amount. Additionally, some patients may have an aversion to seeing or directly handling the needle.
[0003] An injection pen is an example of a conventional injection device. A typical injection pen generally includes a rigid rod that acts on a piston within a cartridge. When the rod advances the piston during the injection process, the drug within the cartridge is administered to the patient through the needle. To accommodate the rod, conventional injection pens are generally elongated, and the length of the injection pen exceeds twice the length of the cartridge barrel in which the drug is contained. Similarly, in the case of a refillable injection device that is not of the conventional pen type, the length of the device generally exceeds twice the length of the cartridge barrel in which the drug is contained.
[0004] When conventional injection devices are used for frequent self-administration of drugs, it may be desirable for the injection device to be convenient to use and easily portable by the user. For example, as described above, diabetic patients often self-administer insulin using an injection device and carry the device with them throughout the day. Conventional injection pens and similar conventional devices are small enough to be portable, but such devices often have a length that makes transporting the device inconvenient.
SUMMARY OF THE INVENTION
MEANS FOR SOLVING THE PROBLEM
[0005] According to an aspect of the present technology, the fluid delivery cassette may include a cartridge assembly and a needle assembly attached to the cartridge assembly. The cartridge assembly may include a cartridge configured to contain a fluid, a partition disposed at a distal opening of the cartridge, and a movable piston that seals a proximal opening of the cartridge, the piston being axially movable within the cartridge, and a drive assembly configured to axially move the piston toward the distal opening. The drive assembly may include an axially extendable portion having a distal end that is controllably extendable along a longitudinal axis from a retracted position to at least one extended position, and a rotatable force transmission portion that receives an applied force and is configured to axially move the distal end of the axially extendable portion in response to the applied force. The axially extendable portion may be a tapered helix and may be manufactured as a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix such that the axially extendable portion is foldable to the retracted position.
[0006] According to another aspect of the present technology, the fluid delivery system may include a disposable dispenser, a reusable cassette housing, and a reusable motor assembly. The dispenser can include a cartridge assembly and a needle assembly attached to the cartridge assembly. The cassette housing may be configured to accommodate at least a portion of the dispenser. The motor assembly may be configured to drive movement within the cartridge assembly, or within the needle assembly, or within both the cartridge assembly and the needle assembly, and may be removably attachable to the cassette housing. The cartridge assembly may include a cartridge configured to contain a fluid, a movable piston that seals a proximal opening of the cartridge and is axially movable within the cartridge, and a drive assembly configured to axially move the piston toward a distal end of the cartridge. The drive assembly may include an axially extendable portion having a distal end that is controllably extendable from a retracted position to at least one extended position, and a rotatable portion driven by the motor assembly to axially move the distal end of the axially extendable portion. The axially extendable portion may be a tapered helix manufactured with a diameter that varies from a first end of the tapered helix to a second end of the tapered helix such that the axially extendable portion is foldable to the retracted position.
[0007] According to a further aspect of the present technology, a method of using a fluid delivery cassette includes actuating the needle assembly of a dispenser by fully inserting the dispenser into a cassette housing; latching a latch mechanism of the cassette housing to the dispenser to prevent movement of the needle assembly relative to the cassette housing; rotating a needle selector of the needle assembly to select a needle of the needle assembly; forming an extension helix to extend an axially extendable portion from a retracted position to an extended position; using the extension helix to apply pressure to a piston within a cartridge and discharging fluid from the cartridge into the needle to cause fluid within the cartridge of the cartridge assembly of the dispenser to be discharged through the needle of the needle assembly. The needle assembly can be prevented from being actuated when the dispenser is not fully inserted into the cassette housing.
[0008] According to another aspect of the present technology, a method of assembling a fluid delivery cassette includes providing a ribbon formed of an elastic material; defining a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix; applying an axial force to an end of the ribbon within the tapered helix to axially crush the ribbon, thereby forming a coil. The axial force can be a force along the axis of the tapered helix. The ribbon within the tapered helix can include edges that are not joined to each other. The method can also include inserting the coil inside a ribbon chamber of a cartridge housing. The cartridge housing can include a cartridge configured to contain fluid, a septum positioned at a distal opening of the cartridge, and a movable piston that seals a proximal opening of the cartridge. Movement of the ribbon along the cartridge housing can cause a cylindrical helix to be formed in an extending portion of the ribbon when the edges of the ribbon are joined to each other. The cylindrical helix can have a consistent diameter sized to fit within the cartridge to engage the piston movably.
[0009] Fluid delivery cassettes having various different features are disclosed herein, and it should be noted that these features may be combined in various different configurations, including configurations not specifically illustrated or discussed. Although some different combinations of such features are described herein, those skilled in the art will understand that additional such combinations, not explicitly described herein, are possible and enabled by this disclosure and are within the scope of this application. Additionally, various techniques for achieving the disclosed features are disclosed herein, and those skilled in the art will understand that some modifications to the disclosed techniques are possible and may be within the scope of the disclosed techniques. Also, it should be understood that the syntax and terminology employed herein are for explanatory purposes and should not be regarded as limiting.
Brief Description of the Drawings
[0010] Various aspects, techniques, and embodiments of the technology disclosed herein are described below with reference to the accompanying drawings. It should be understood that the drawings are not necessarily drawn to scale. Items appearing in multiple figures may be denoted by the same reference numerals. For clarity, not all components may be labeled in all of the figures. By referring to the following detailed description considered in conjunction with the accompanying drawings, the features of the technology will become more apparent and the techniques for how to achieve the features of the technology will be better understood.
Figure 1
Figure 2
Figure 3
Figure 4A
Figure 4B
Figure 4C
Figure 4D
Figure 4E
Figure 5
Figure 6A
Figure 6B
Figure 6C
Figure 6D
Figure 7A
Figure 7B
Figure 7C
Figure 8
Figure 9A
Figure 9B
Figure 9C
Figure 10
Figure 11A
Figure 11B
Figure 12A
Figure 12B
Figure 12C
Figure 13A
Figure 13B
Figure 13C
Figure 13D
Figure 14A
Figure 14B
Figure 14C
Figure 14D
Figure 15A
Figure 15B
Figure 15C
Figure 16A
Figure 16B
Figure 16C
Figure 16D
Figure 17A
Figure 17B
Figure 17C
Figure 18A
Figure 18B
Figure 18C
Figure 19
Figure 20A
Figure 20B
Figure 21
DETAILED DESCRIPTION OF THE INVENTION
[0011] Provided herein are examples of fluid delivery cassettes, as well as examples of components included in fluid delivery cassettes, examples of systems that can use fluid delivery cassettes, and techniques for achieving fluid delivery cassettes. As will be understood, some embodiments of fluid delivery cassettes are described herein in the context of drug administration to a patient, but such cassettes are not limited to use in medical applications and may additionally or alternatively be used in other non-medical applications (e.g., where an accurate amount of fluid is delivered).
[0012] The inventors recognize and understand that various factors can be important for fluid delivery cassettes. In particular, ease of use of the fluid delivery cassette can be important, but minimizing medical waste can also be important. The fluid delivery cassettes provided herein have multiple needles and are individually actuated to deliver multiple doses of a drug from a single vial or fluid chamber, thus reducing waste associated with multiple needle packages and / or multiple single-dose vials of the drug. The multiple doses may be injected at different times using different needles of the set, or the doses may be injected at different times using a single needle of the set. For example, a patient may use one needle for multiple injections in a day and another needle for multiple injections on another day. In some embodiments, a single-needle configuration can also be used in accordance with the techniques described herein.
[0013] Various embodiments of the fluid delivery cassette provided herein may enable an accurate amount of fluid to be injected from a single vial or fluid chamber through controlled movement of a piston. For example, by controlling the exact amount of rotation of a drive gear (e.g., via a computer-controlled motor), the drive gear may expand the length of an extendable ribbon and push the piston by an accurate amount. One of the advantages of the fluid delivery cassette provided herein is that the configuration of the extendable ribbon and the drive assembly for driving the expansion and retraction of the ribbon may enable the cassette to be compact and have a relatively short length. Such a compact cassette can still provide accurate fluid control by using the various techniques described herein.
[0014] Conventionally, a ribbon is manufactured in a tubular shape such that the ribbon forms a cylindrical or tubular helix and the diameter from the first end of the helix to the second end of the helix does not substantially change. The inventors have recognized and understood that such a tubular shape requires a radial force to be applied to wind the helix into a coil, and further requires an axial force to compress or flatten the helix into a coil. Thus, such a tubular shape can be time-consuming and / or difficult to work with when repositioning the helix into a coil for installation within a fluid delivery cassette or within a component of a fluid delivery cassette such as a ribbon chamber. Accordingly, the inventors have developed a technique for providing a tapered helix. When not confined within a ribbon chamber and with no force applied to the ribbon (e.g., in a stress-free state), the ribbon can form a tapered helix having a diameter that varies from the first end of the tapered helix to the second end of the tapered helix (e.g., as shown in FIGS. 6A and 6B). The taper may be formed along the cross-sectional area of the helix and increase along the longitudinal axis (e.g., axis A in FIG. 2) from the first end to the second end. The tapered helix may or may not have a gap between segments or loops of the helix when viewed in a side view. Such a tapered structure can facilitate the manufacture of a cartridge assembly, as discussed herein. For example, in a tapered structure, the ribbon can be easily folded into a coil by applying an axial force (e.g., by the squeezing action between two fingers) to compress the first and second ends towards each other, which can facilitate the insertion of the coil onto a spindle and into a ribbon chamber, as described herein. As a result, the tapered helix does not require a radial force to be applied to wind the helix around itself and can be pushed into a coil.
[0015] The fluid delivery cassette may include a reusable portion and a disposable portion. In various embodiments of the cassette disclosed herein, one or more needles and / or a dispenser with a fluid to be injected by one or more needles may be disposable. In various embodiments of the cassette disclosed herein, a housing configured to receive the dispenser and / or support one or more driver assemblies for driving movement within the dispenser may be reusable. One or more driver assemblies and a controller for controlling the one or more driver assemblies may also be reusable. In some embodiments, the fluid delivery cassette according to the present technology may be part of a drug delivery device. For example, the housing of the drug delivery device may house the fluid delivery cassette, a motor assembly configured to drive movement within the fluid delivery cassette, and a controller (e.g., a computer processor) configured to control the motor assembly.
[0016] The following is a more detailed description of various concepts and embodiments of techniques related to the technology described above. It should be understood that the various aspects described herein can be implemented in any of a number of ways. Examples of specific embodiments are provided herein for illustrative purposes only. Additionally, the various aspects described in the following embodiments may be used alone or in any combination and are not limited to the combinations explicitly described herein.
[0017] Referring now to the drawings, FIG. 1 shows a perspective view of a dispenser 10 comprising a cartridge assembly 100 and a needle assembly 200, according to some embodiments of the present technology. The dispenser 10 can be used within a fluid delivery cassette, as described below. The needle assembly 200 may be disposed at the distal end of the dispenser 10. For clarity, the term "distal" may be used herein to identify a position closer to the exit of the needle of the needle assembly (e.g., closer to the end that contacts the patient being injected with the needle), and the term "proximal" may be used herein to identify a position farther from the exit of the needle. As discussed below, the dispenser 10 can form one aspect of a drug delivery device. Although some aspects of the drug delivery device may be described herein and / or shown in the drawings, it should be understood that some aspects of the drug delivery device may not be shown in the figures and / or may not be described, or may not be shown in detail in the figures and / or may not be described in detail. For example, a housing of the drug delivery device may house the dispenser 10. The housing of the drug delivery device can include other components and electronics for enabling operation of the dispenser. For example, the housing can also include one or more motors for driving movement within or relative to the dispenser 10, and a computer processor for controlling the operation of the one or more motors.
[0018] According to some embodiments of the present technology, FIG. 2 shows a perspective view of the assembled cartridge assembly 100, and FIG. 3 shows a perspective view of the cartridge assembly 100 in a partially disassembled state. The cartridge assembly 100 may include a cartridge 150 configured to hold a fluid (e.g., a liquid drug) therein. The fluid may be defined by a piston 156 configured to seal a proximal opening of the cartridge 150 and may be confined within a fluid chamber 158 defined by a septum 152 configured to seal a distal opening of the cartridge 150. A septum retainer 154 may be coupled to the distal end of the cartridge 150 to hold the septum 152 in a fixed position at the distal opening of the cartridge 150. In some embodiments, the piston 156 may provide a movable seal against the inner surface of the cartridge 150 to prevent fluid within the fluid chamber 158 from leaking out of the proximal end of the fluid chamber 158 even during movement of the piston 156 along the inner surface of the cartridge 150. The septum 152 may be pierced by a piercing object of the needle assembly 200 during an injection process to allow fluid within the fluid chamber 158 to flow out of the fluid chamber 158 and may be resealed to provide a fluid tight seal after the piercing object is withdrawn from the septum 152 and may be formed from a self-sealing material (e.g., an FDA-grade elastomeric material). In some embodiments, the withdrawal of the piercing object from the septum 152 and subsequent resealing of the septum 152 may prevent contamination of the fluid remaining within the fluid chamber 158 such that the remaining fluid can be used in a future injection process. In some embodiments, the fluid within the fluid chamber 158 may be sufficient for multiple injections (e.g., multiple administrations of a drug).
[0019] The device according to the present disclosure, which may also be referred to as an agent or a drug, may convey and dispense one or more liquid agents that may be held within the fluid chamber 158. Such agents include, for example, epinephrine, anesthetics, analgesics, steroids, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, GIP / GLP-1 combination agonists such as tildesatide, basal insulin, oxyntomodulin analogs, oxyntomodulin derivatives, but not limited to, IL-23 antibody analogs or derivatives such as mirikizumab, IL-17 antibody analogs or derivatives such as ixekizumab, therapeutic antibodies, therapeutic agents for pain-related treatments such as galcanezumab or lasmiditan, or lebrikizumab, and any therapeutic agent that can be delivered by the device described herein. The device according to the present disclosure can generally be operated by a user (e.g., a medical professional, a caregiver, or another person) in the manner described herein to deliver one or more agents to a patient (e.g., another person or the user).
[0020] The cartridge 150 can be held within the housing 102 of the cartridge assembly 100. In some embodiments of the present technology, the housing 102 can have a cylindrical shape, as shown in FIG. 3, and a plurality of ribs 114 can extend radially from the inner surface of the housing 102. The ribs 114 can function as spacers to hold the cartridge 150 in a predetermined position within the cartridge chamber 108 of the housing 102. In some embodiments, the ribs 114 may have rib shoulders 114a configured to function as the axial insertion limit of the cartridge 150 within the housing 102. In some embodiments, when the cartridge 150 is fully inserted into the cartridge chamber 108, the edge of the proximal end of the cartridge 150 may abut against the rib shoulder 114a, and the cartridge 150 may be centered radially within the cartridge chamber 108. In some embodiments, when the cartridge 150 is fully inserted into the cartridge chamber 108, the septum 152 may extend outward from the distal end of the housing 102 such that the septum 152 can be positioned within the recess of the needle assembly 200.
[0021] In some embodiments of the present technology, the cartridge assembly 100 may include a drive assembly 300 configured to drive the movement of the piston 156 to discharge the fluid in the fluid chamber 158 from the distal end of the cartridge 150. The drive assembly 300 can be driven to move itself and then convert the received driving force into a force that moves the piston 156 along the axis A of the cartridge assembly 100, so it can be called a "driven" assembly. In some embodiments, the drive assembly 300 may include a driven mechanism 302 which may be a drive gear 302 configured to be driven to rotate about the axis A. The driven mechanism 302 may include a spindle 302a around which an axially extendable member 306 may be wound. In some embodiments, the axially extendable member 306 may be a ribbon having a distal end attached to the foot 304 (element 306 may alternatively refer to either an axially extendable member or a ribbon). The foot 304 may be configured to rotate relative to the distal end of the rotating ribbon 306. The drive assembly 300 may be configured such that when the driven mechanism 302 is rotated in a first direction, the rotation of the driven mechanism 302 causes the ribbon 306 to extend or expand along the axis A. In some embodiments, the driven mechanism 302 may retract the ribbon 306 when the driven mechanism 302 is rotated in a second direction opposite to the first direction. As will be described below, when the ribbon 306 is driven to extend, the axial distance between the distal end and the proximal end of the ribbon 306 expands or increases, moving the foot 304 axially. When the foot is in contact with the piston 156, the expansion of the ribbon 306 moves the piston 156 axially towards the distal opening of the cartridge 150. In some embodiments, precise control of the amount of rotation of the driven mechanism 302 can result in a precise amount of expansion of the ribbon 306 and a precise amount of movement of the piston 156, and thus can result in a precise amount of fluid being discharged.An additional ribbon extension mechanism is described in International Publication No. WO 2017 / 165154 (A1) and International Publication No. WO 2019 / 112866 (A1), both of which are incorporated herein by reference in their entirety.
[0022] Figures 4A and 4B are perspective views of a longitudinal cross-section of a cartridge assembly 100 according to some embodiments of the present technology. Figure 4C is a perspective view of a cross-section of the cartridge assembly 100 cut along plane 4C in the view of the cartridge assembly 100 shown in Figure 4A according to some embodiments of the present technology. In Figures 4A and 4B, the foot 304 of the drive assembly 300 is spaced apart from the piston 156. As will be appreciated, during the injection process, the foot 304 may be in contact with the piston 156. The distal surface of the foot 304 may include a groove 304a configured to engage a protrusion 156a on the proximal surface of the piston 156. For example, the groove 304a may be circular, and the protrusion 156a may be a bump configured to fit into the groove 304a when the foot 304 and the piston 156 are in contact with each other. In some embodiments, the foot 304 may be configured to rotate about axis A, while the protrusion 156a remains fixed in the direction of rotation when the piston 156 is being pushed by the foot 304.
[0023] Figure 4D is a plan view of a slice of the cartridge assembly 100 cut along a parallel plane 4D in the view of the cartridge assembly 100 shown in Figure 4A according to some embodiments of the present technology. In some embodiments, the foot 304 may be connected to the distal end of the ribbon 306 by a bearing 308, which may rotate during extension and retraction of the ribbon 306 and may allow the foot 304 to remain non-rotating during extension and retraction of the ribbon 306. The proximal surface of the foot 304 may have a socket recess configured to receive a ball-shaped protrusion of the bearing 308, and the bearing 308 may rotate within the socket recess during extension and retraction of the ribbon 306.
[0024] According to some embodiments of the present technology, when the ribbon 306 is in a fully retracted state, some or all of the ribbon 306 may be wound in a coiled shape around the spindle 302a such that the loops of the coil have proximal edges that are generally aligned with each other and distal edges that are generally aligned with each other. Thus, when the ribbon 306 is fully retracted, the coil may be compact and may fit within the ribbon chamber 110 of the housing 102 located at the proximal end 104 of the housing 102. In some embodiments, when the driven mechanism 302 rotates to extend the ribbon 306, the axially elongated spindle rib 302b that projects radially from the longitudinal portion of the spindle 302a may abut against the rib latch 306c that projects from the surface of the ribbon 306 and rotate the ribbon 306 to unwind it. In some embodiments, the spindle rib 302b and the rib latch 306c may be structured to have complementary angles for latching or hooking onto each other as depicted in FIG. 4D. In some embodiments, the ribbon 306 may be unwound to form a helix having an axial length that is controlled by the amount of rotation of the driven mechanism 302. Thus, through the controlled rotation of the driven mechanism, a controlled movement of the piston 156 can be achieved, and as a result, a controlled release of fluid within the fluid chamber 158 can be achieved. In some embodiments, the cartridge assembly 100 may be structured such that a predetermined number of rotations of the driven mechanism 302 can result in a movement of the foot 304 of 0.2 mm or 0.3 mm or 0.4 mm or 0.5 mm. In some embodiments, one complete rotation (e.g., a 360° rotation) can result in a known amount of movement of the foot 304 and / or a known amount of movement of the piston 156 pushed by the foot 304.
[0025] According to some embodiments of the present technology, the ribbon 306 may be unwound "from the inside out" such that the innermost loop of the coil in contact with the spindle rib 302b is first unwound and extends or expands to form a growing helix. For example, FIGS. 3, 4A, and 4B depict a retracted portion 306a of the ribbon 306 formed from the outer coil loops of the ribbon 306 and an extending portion 306b of the ribbon 306 extending from the inner coil loops of the ribbon 306 to form a helix.
[0026] The helix formed from the extending portion 306b of the ribbon 306 may be guided by the helical guide 112 from the ribbon chamber 110 of the housing 102 to the cartridge chamber 108 of the housing. The non-extending or retracted portion 306a of the ribbon 306 may remain wound within the ribbon chamber 110. In some embodiments of the present technology, the helical guide 112 may be a tubular section of the housing 102 having a diameter smaller than the diameter of the cartridge chamber 108. The diameter of the helix may correspond to the diameter of the helical guide 112. In some embodiments, the rib 114 of the housing 102 may extend radially from the inner surface of the housing 102 and may contact the outer surface of the helical guide 112 as depicted in FIG. 4D.
[0027] FIG. 4E shows a plan view of the proximal end 104 of the cartridge assembly 100 according to some embodiments of the present technology. The driven mechanism 302 may fit within the ribbon chamber 110 of the housing 102 and may be placed on a lip 110b extending from the inner surface of the ribbon chamber 110 (see FIG. 5). The driven mechanism 302 may be configured to engage with a driver, which will be described later, and be rotated by the driver. In some embodiments, the surface of the driven mechanism 302 may include a recess 302c configured to receive a spline shaft therein. The recess 302c may be formed within the spindle base 302e of the spindle 302a, and a longitudinal portion may extend therefrom. The spindle base 302e may include a disk-shaped body having a spindle base diameter. The recess 302c may have concave teeth 302d configured to engage with corresponding teeth of the spline shaft. As will be appreciated, the driven mechanism 302 may be configured with other structures that allow the driven mechanism 302 to be rotated. For example, instead of the recess 302c, a shaft (e.g., a spline shaft) may be provided on the surface of the driven mechanism 302 and engage with an electric device having a recess (e.g., a spline-shaped recess) that fits with the shaft and be configured to be rotated by this electric device.
[0028] FIG. 5 schematically shows a plan view of a longitudinal cross-section of a portion of the proximal ends of a first variant 5A and a second variant 5B of the cartridge assembly 100 according to some embodiments of the present technology. The first and second variants 5A, 5B may be composed of a housing 102', which is a variant of the housing 102. The first variant 5A may include a ribbon container 116 that may be insertable into the housing 102, which may facilitate manufacturing by allowing a ribbon bobbin composed of the ribbon container 116, the ribbon 306, and the driven mechanism 302 to be separately manufactured and easily installed as a unit within the housing 102'. In some embodiments, the ribbon chamber 110' of the ribbon container 116 may have a distal base that is inclined to facilitate helix formation by providing space for the inner loop of the coil to unwind while the outer loop of the coil remains together within the coil and is relatively restricted. The second variant 5B may include a ribbon container 116' similar to the ribbon container 116, but may have a ribbon chamber 110'' that is smaller in volume than the ribbon chamber 110' of the first variant 5A, and the shorter dimension in the axial direction may result in a more tightly wound ribbon chamber 110'' in the axial direction. The more tightly wound ribbon chamber 110'' in the axial direction may be sized to be closely associated with the width between the edges of the ribbon to facilitate restraint and reduction of slippage when the ribbon 306 is moving into an extended configuration. The second variant 5B may include a driven mechanism 302' having a concave outer surface, and the peripheral edge of the driven mechanism 302' may be coplanar with the proximal edge 102a' of the housing 102', but the remaining portion of the driven mechanism 302' may be recessed with respect to the proximal edge 102a'. Such a recessed configuration can advantageously allow for a more reliable engagement between the driven mechanism 302' and the driver, and thus enable a higher level of confidence that rotation or partial rotation of the driven mechanism 302' will result in a predictable axial movement of the plunger 156. In another variant, the ribbon containers 116, 116' may not be components insertable into the housing 102' and may instead be an integral structure of the housing 102'.For example, the housing 102' may be formed from molded plastic such that the ribbon chamber of the housing 102' has an internal structure corresponding to the ribbon containers 116, 116'. As shown in FIG. 5, the surfaces of the spindles 302a, 302a' can have a tapered profile such that the diameter of the spindles 302a, 302a' gradually decreases from a relatively large diameter at the proximal ends of the spindles 302a, 302a' to a relatively small diameter at the distal ends of the spindles 302a, 302a'. In some embodiments, the spindles 302a, 302a' may have a conical shape. The tapered profile of the spindles 302a, 302a' can allow for smooth movement of the ribbon 306 relative to the spindles 302a, 302a' as the helix extends axially in length. For example, the tapered profile can allow the innermost coil of the ribbon 306 to gradually unwind and become part of the expanding helix. In some embodiments, the spindle ribs 302b, 302b' may extend radially from the tapered surfaces of the spindles 302a, 302a' such that the radial distance d from each radially outer edge of the spindle ribs 302b, 302b' to the axis A may be the same along the respective axial lengths of the spindle ribs 302b, 302b', as shown in FIG. 5. Such a configuration of the spindle ribs 302b, 302b' can cause the helix to have a cylindrical shape.
[0029] FIGS. 6A and 6B show elevation side views of the ribbon 306 in a stress-free state according to some embodiments of the present technology. In FIGS. 6A and 6B, the distal end of the ribbon 306 is on the left side and the proximal end of the ribbon 306 is on the right side. The distal end of the ribbon can be structured as a latch 306f that can directly engage the foot 304 or engage the bearing 308, as described herein.
[0030] According to some embodiments of the present technology, the ribbon 306 is not confined within the ribbon chamber 110 and, in a state where no force is applied to the ribbon 306 (e.g., a state where no stress is applied), the ribbon 306 can form a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix, as shown in FIGS. 6A and 6B. The ribbon 306 can be formed of an elastic material such that the taper may be formed along the cross-sectional area of the helix increasing from the distal end to the proximal end along the axis A. The tapered helix may or may not have a gap between segments or loops of the helix when viewed in a side view (e.g., the views of FIGS. 6A and 6B). FIG. 6C shows a view of the end of the ribbon 306 in a state where no stress is applied, and the outer surface of the latch 306f is visible (e.g., when viewed from the distal end to the proximal end of the ribbon 306). FIG. 6D shows a view of the end of the ribbon 306 in a state where no stress is applied, and the inner surface of the latch 306f is visible (e.g., when viewing the tapered helix from the proximal end to the distal end of the ribbon 306). An advantageous aspect of the ribbon 306 having a tapered structure is that such a structure can facilitate the manufacture of the cartridge assembly 100. In the tapered structure, the ribbon 306 can be easily folded into a coil by applying an axial force (e.g., by the compressing action between two fingers) to compress the distal end and the proximal end towards each other, facilitating the insertion of the coil onto the spindle 302a and into the ribbon chamber 110. For example, the tapered helix can be crushed to form a coil when the first end of the tapered helix is disposed against a flat surface (e.g., a table) and an axial force is exerted on the second end towards the flat surface. The material and forming technique of the ribbon 306 can be applied to obtain a desired tapered profile.
[0031] According to some embodiments of the present technology, the rib latch 306c of the ribbon 306 described above may protrude from one of the two surfaces of the ribbon 306. In some embodiments, the rib latch 306c may protrude from the surface forming the inner surface of the tapered helix, as shown in FIGS. 6A, 6B, and 6C. The rib latch 306c may be configured to engage and slide along the spindle rib 302b when the ribbon 306 is expanded or extended axially. In some embodiments, as described above, the rib latch 306c of the innermost loop of the coil (e.g., the innermost loop of the retracted portion 306a of the ribbon 306) may contact the spindle rib 302b and be rotated by the rotation of the spindle rib 302b to form a growing or elongating helix. The innermost loop of the coil may be a continuously changing portion of the ribbon 306 as the helix elongates. The rib latch 306c sliding along the spindle rib 302b can continuously slide off the spindle rib 302 as the helix elongates. Similarly, the rib latch 306c of the retracted portion 306a of the ribbon 306 may continuously engage the spindle rib 302b as the helix elongates. In some embodiments, computerized control of the amount of rotation of the drive mechanism 302 may expand the ribbon 306 to one or more predetermined positions, each predetermined position corresponding to a known amount (or known incremental amount) of fluid discharged from the fluid chamber 158 relative to a previous predetermined position.
[0032] According to some embodiments of the present technology, the groove 310 may be provided on the surface of the ribbon 306 opposite to the surface on which the rib latch 306c is provided. In some embodiments, the groove 310 may be provided on the outer surface of the ribbon 306, as shown in FIGS. 6A and 6B. The groove 310 may be configured to slide along the protruding raised portion 110a proximate to the proximal end of the helical guide 112. In some embodiments, the movement of the ribbon 306 along the raised portion 110a and along the spindle rib 302b may cause the extended helix to be cylindrical or tubular, which structurally may provide enhanced stiffness to the helix against the piston 156 during pushing against the piston 156. In some other embodiments, the movement of the ribbon 306 along the raised portion 110a and along the spindle rib 302b may cause the extended helix to be tapered or conical. In some embodiments, the raised portion 110a may be the helical ridges 111a, 111a' on the inner surface of the ribbon containers 116, 116'. The helical ridges 111a, 111a' may fit into the groove 310 and engage slidably during the extension of the helix.
[0033] The edges of the ribbon form a helical configuration such that when the ribbon extends axially, adjacent edges of the ribbon engage, and in some embodiments, may include complementary coupling features that allow them to decouple from each other when the ribbon is retracted or when transitioning to a coil configuration. According to some embodiments of the present technology, the ribbon 306 may comprise a plurality of pegs 306d disposed along a first edge of the ribbon 306 and a plurality of holes 306e disposed along a second edge of the ribbon opposite the first edge. In some embodiments, the pegs 306d may project from the surface forming the inner face of the ribbon 306, as depicted in FIGS. 6A, 6B, and 6C. That is, the pegs 306d and the rib latch 306c may project from the same surface of the ribbon 306, and the rib latch 306c extends longitudinally from an edge region near the peg 306c to the second edge of the ribbon 306. The pegs 306d and the holes 306e are configured such that as the ribbon 306 expands or extends, an increasing number of pegs are received in an increasing number of holes to form a helix such that each loop of the helix engages at least one adjacent loop of the helix.
[0034] Figures 6A and 6B show a ribbon 306 of an extending configuration that forms a tapered helix, which is for illustrative purposes to show an aspect of the ribbon 306. This means that as the ribbon 306 extends, the lower edge of the loop of the helix (formed, for example, from the lower edge of the ribbon 306) adheres to the upper edge of the loop of the helix (formed, for example, from the upper edge of the ribbon 306), and the ribbon 306 is unrolled onto itself in a structured manner so that it can be unrolled from the coil in a zipper-like configuration to form a helix. It should be understood that in some embodiments, the ribbon 306 may be manufactured and deployed within the cartridge assembly 100 as shown in FIG. 1 with some, most, or all of the ribbon 306 wound around itself such that it is retracted into a coil having a height corresponding to the edge-to-edge distance of the ribbon 306 (without the need for a force exerted on the ribbon 306 to maintain the ribbon 306 within the coil). As a result, in the initial configuration (e.g., before using the dispenser 10 to administer any of the fluids within the fluid chamber 158), some, most, or all of the ribbon 306 may be retracted and wound around itself in a coiled manner. As discussed herein, as the ribbon 306 extends and joins onto itself to form a helix, a structured tapered shape may result, or a cylindrical shape may result, each of which may provide accurate and effective administration through the precise expansion of the helix, as also discussed herein.
[0035] Figures 7A and 7B show perspective views of a cartridge assembly 100 and a driver gear 402 configured to rotationally drive a driven mechanism 302 of a drive assembly 300, according to some embodiments of the present technology. FIG. 7C shows a perspective view of the driver gear 402. In some embodiments, the driver gear 402 may be included as part of a cassette and may be incorporated within a housing of the cassette, as depicted in FIGS. 10, 20A, and 20B. In some embodiments, the driver gear 402 may include a disc-shaped body having a diameter of the driver gear and gear teeth circumferentially spaced from each other along a circumferential edge surface of the disc-shaped body. In some embodiments, the driver gear 402 may include a spline shaft 404 extending from a surface facing the axial direction of the driver gear 402. The spline shaft 404 may be configured to fit into a recess 302c on a surface of the driven mechanism 302, and the spline shaft 404 may have teeth configured to engage with the concave teeth 302d of the recess 302c. The bodies of the recess 302c and the spindle 302a may have a coaxial relationship along the longitudinal axis A, as shown in FIGS. 7A and 7B. In some embodiments, the driver gear 402 may be a spur gear type gear configured to be driven to rotate via a force applied to the teeth 402a of the driver gear 402. Rotation of the driver gear 402 may drive rotation of the driven mechanism 302 via the spline shaft 404 of the driver gear 402 and the recess 302c and teeth 302d of the driven mechanism 302. In some embodiments, when the cartridge assembly 100 is inserted into the housing of the cassette (e.g., axially inserted as shown in FIG. 10), the spline shaft 404 may be arranged along the longitudinal axis A to facilitate insertion coupling with a recess 302c of the cartridge assembly 100 that may be arranged along the longitudinal axis A. The driver gear 402 and the driven mechanism 302 may be arranged together and may advantageously reduce the amount of thrust received by the ribbon 306 and the cassette.In some embodiments, the driver gear diameter of the body of the driver gear 402 may be at least as large as the spindle base diameter of the spindle base 302e of the spindle 302a.
[0036] FIG. 8 shows a perspective view of the dispenser 10 according to some embodiments of the present technology. In FIG. 8, the housing 202 of the needle assembly 200 is shown as translucent so that the internal components are visible. FIG. 9A shows a perspective view of the needle assembly 200, and FIG. 9C shows a perspective view of the needle assembly 200 in a partially disassembled state. FIG. 9B shows a plan view of a cross-section of the needle assembly 200 cut along the plane 9B of FIG. 9A.
[0037] According to some embodiments of the present technology, the needle assembly 200 may be attached to the distal end of the cartridge assembly 100 such that the partition wall 152 of the cartridge assembly 100 is received within the recess of the needle assembly 200. In some embodiments, during the injection process, the piercer of the needle assembly 200 may be driven to pierce the partition wall 152, enabling the fluid within the fluid chamber 158 to be discharged from the fluid chamber 158. For example, the partition wall 152 may be pierced according to the techniques described in International Application No. PCT / US2021 / 063178 entitled "Fluid Delivery System with Needle Assembly" or International Application No. PCT / US2021 / 063180 entitled "Fluid Delivery System with Needle Assembly", each of which is hereby incorporated by reference in its entirety. Examples of the housing of a drug delivery device that may be coupled to the dispenser 10 can be found in these international applications. In some embodiments where the fluid is a liquid drug, the fluid discharged from the fluid chamber 158 may be injected into a patient through the needle 216 of the needle assembly 200. The needle assembly 200 may carry a single needle or multiple needles (e.g., two needles, three needles, four needles, etc.) as discussed herein.
[0038] According to some embodiments of the present technology, the needle assembly 200 may include a plurality of needles 216 that can be individually actuated for use. The needle assembly 200 may include a needle selection gear 204 that can be driven to move a selected one of the needles 216 to an actuated position. The selected needle 216 may be the next needle among the plurality of needles 216 or a specific needle among the plurality of needles 216. The selected needle 216 can be rotated to the actuated position by the rotation of the needle selection gear 204 through the operation of the driver assembly 600 (FIG. 19) described below. In some embodiments, each needle 216 of the needle assembly 200 may be operably connected to a needle movement gear 208 and a gear assembly 208a, which is configured to axially move the needle 216 from a retracted position within the housing 202 where the needle tip is retracted from the base surface 202c at the distal end of the housing 202 to an injection position where the needle tip extends beyond the base surface 202c (e.g., into the patient). When the needle 216 is not in the actuated position, the needle 216 cannot move from the retracted position to the injection position.
[0039] According to some embodiments of the present technology, when the needle 216 is in the actuated position (the "actuated needle"), the transmission gear 206 of the needle assembly 200 can drive the movement of the needle 216 between the injection position and the retracted position. The transmission gear 206 is also referred to herein as an idler 206. In some embodiments, when in the actuated position, the teeth of the needle movement gear 208 of the actuated needle 216 may be meshed with the teeth of the transmission gear 206 such that the rotation of the transmission gear 206 can drive the rotation of the needle movement gear 208. The transmission gear 206 can be driven to rotate through the operation of the driver assembly 400 (FIG. 19) described below. The rotation of the needle movement gear 208 by the transmission gear 206 can axially move the actuated needle 216 from the retracted position to the injection position.
[0040] The inventors recognize and understand that safety is an important consideration in the use of the dispenser 10, particularly when the dispenser 10 is used by a layperson who has not received training in handling needles and / or injection fluids (e.g., liquid medications). Accordingly, the inventors have provided a gear lock mechanism for the dispenser 10. The gear lock mechanism may prevent the needle selection gear 204 from positioning any of the needles 216 in the operative position and / or prevent the transmission gear 206 from moving any of the needle movement gears 208, as discussed herein, unless certain unlock features are satisfied.
[0041] One such gear locking mechanism is the locking spring 210, which can include a U-shaped spring surface 210a configured to prevent rotation of the needle selection gear 204 and prevent rotation of the transmission gear 206 when the locking spring 210 is in the locked position. FIG. 9B shows the surface of the needle assembly 200 on the left side of the plane 9B (see FIG. 9A) with the locking spring 210 in the locked position according to some embodiments of the present technology. When the locking spring 210 is in the locked position, the protrusion 210b of the spring surface 210a enters the space within the needle assembly 200 and prevents rotation of the needle selection gear 204. For example, the protrusion 210b may span one of the gear assemblies 208a as shown in FIG. 9B, or may be inserted between two of the gear assemblies 208a, whereby the protrusion 210b may prevent rotation of the needle selection gear 204 and prevent movement of the needle 216 to the operating position. Additionally, when the locking spring 210 is in the locked position, the base of the spring surface 201a may abut against the transmission gear 206 to prevent rotation of the transmission gear 206. For example, a protrusion on the stem portion of the transmission gear 206 may seat within a recess within the base of the locking spring 210 so that the transmission gear 206 cannot rotate. In some embodiments, the locking spring 210 and the transmission gear 206 may be mounted on the support frame 212 of the needle assembly 200. The support frame 212 may be attached to a needle sub-assembly 214 consisting of the needle 216, the needle selection gear 204, and the needle movement gear 208, and may be positioned such that when the locking spring 210 is in the unlocked position, the transmission gear 206 can rotate the needle movement gear 208 of the needle 216 in the operating position. In some embodiments, the transmission gear 206 may be movably mounted on the frame post 212a of the support frame 212, and the protrusion 210b of the spring surface 210a may span the transmission gear 206 and the frame post 212a as depicted in FIG. 9B.As described below, when the lock spring 210 moves from the locked position to the unlocked position, the base of the spring surface 210a may be shifted away from the transmission gear 206, and the protrusion 210b of the spring surface may be shifted away from the gear assembly 208a. Thus, the needle selection gear 204 can rotate the selected needle among the needles 216 to an operating position adjacent to the transmission gear 206, and the transmission gear 206 can also rotate and drive the needle movement gear 208 of the actuated needle 216.
[0042] FIG. 10 shows a perspective view of a cassette 20 comprising a dispenser 10 partially inserted within a cassette housing 22, according to some embodiments of the present technology. In some embodiments, the needle assembly 200 and the cartridge assembly 100 are assembled together to form the dispenser 10, but when the dispenser 10 is not installed within the cassette housing 22, the lock spring 210 is in the locked position. This can function as a safety mechanism to prevent accidental movement of the needle 216 to the injection position. In some embodiments, the cassette housing 22 may comprise a compartment 26 configured to receive the needle assembly 200. When the dispenser 10 is fully inserted into the cavity of the cassette housing 22, a portion of the compartment 26 can move the lock spring 210 to the unlocked position.
[0043] FIG. 11A shows a perspective view of a partial longitudinal cross-section of a needle assembly 200 partially inserted into a compartment 26 of a cassette housing 22 according to some embodiments of the present technology. Since the needle assembly 200 is not fully inserted into the compartment 26, the locking spring 210 of the needle assembly 200 may be in the locked position. In some embodiments, when the base 24 of the cassette housing 22 is not aligned with the base 202c of the housing 202 of the needle assembly 200, the needle assembly 200 may not be fully inserted into the compartment 26 such that the inner recess 28b of the compartment 26 does not engage the edge portion of the housing 202 as depicted in FIG. 11A. The arrow in FIG. 11A indicates the direction of movement of the needle assembly 200 relative to the cassette housing 22 during installation of the dispenser 10 into the cassette housing 11. The compartment 26 can include a base 26a that supports a tongue base 28a and a tongue 28 that projects axially from the tongue base 28a. The tongue 28 can be configured to engage the locking spring 210 and move the locking spring 210 from the locked position to the unlocked position when the needle assembly 200 is fully inserted into the compartment 26 of the cassette housing 22. FIG. 11B shows the needle assembly 200 fully inserted into the compartment 26 of the cassette housing 22 such that the base 24 of the cassette housing 22 is in the same plane as the base 202c of the housing 202 of the needle assembly 200. When fully inserted, the tongue 28 extending from the base 26a of the compartment 26 can push a portion of the locking spring 210, compress the locking spring 210, and move the locking spring 210 such that the base of the spring face 210a can be shifted away from the transmission gear 206 and the projection 210b of the spring face 210a can be shifted away from the gear assembly 208a, thus unlocking the locking spring 210. Such a shift enables the needle selection gear 204 to rotate and thus enables the selected needles of the needles 216 to be moved to the actuated position and also enables the transmission gear 206 to rotate and drive the needle movement gear 208 of the actuated needles 216.
[0044] FIG. 12A shows a perspective view of the distal section of the dispenser 40 according to some embodiments of the present technology. The dispenser 40 may be similar to the dispenser 10 described above in many respects. The parts of the dispenser 40 that are the same as those of the dispenser 10 may be represented by the same reference numerals. The parts of the dispenser 40 that are changes to the dispenser 10 may be represented by a modified version of the same reference numeral (e.g., with an apostrophe or double prime added after the reference numeral). In some embodiments, the gear lock mechanism of the dispenser 40 may be different from the gear lock mechanism of the dispenser 10. FIG. 12B is the same view as FIG. 12A, but shows a view in which the housing 202' of the needle assembly 200' of the dispenser 40 appears translucent. FIG. 12C shows a perspective view of the distal section of the dispenser 40 in a partially disassembled state according to some embodiments of the present technology.
[0045] According to some embodiments of the present technology, the gear lock mechanism of the dispenser 40 can include a lock spring 211, and the lock spring 211 can include a lock plate 211a and a coil spring 211b configured to prevent rotation of the needle selection gear 204 and prevent rotation of the transmission gear 206' when the lock spring 211 is in the locked position. According to some embodiments of the present technology, FIG. 13A shows a longitudinal cross-sectional view of the needle assembly 200' in the locked state, and FIG. 13B shows the same view of the needle assembly 200' in the unlocked state. In some embodiments, the lock spring 211 and the transmission gear 206' may be movably mounted on the needle sub-assembly 214 via a support frame 212'. The coil spring 211b, the lock plate 211a, and the transmission gear 206' may be movably mounted to a frame post 212a' of the support frame 212' such that the coil spring 211b biases the lock plate 211 and the transmission gear 206' to the unlocked position. In the unlocked position, an end of the frame post 212a' may be partially disposed within a cavity 206a of the transmission gear 206'. As depicted in FIG. 13A, the coil spring 211b may bias the lock plate 211a against the transmission gear 206a' such that, at rest, the transmission gear 206' is pushed against a rib or lip 203 protruding from the housing 202' to prevent rotation of the transmission gear 206'. In this position, the transmission gear 206' may not fully engage with the needle movement gear 208 of the actuated needle 216 as shown in FIG. 13A. Additionally, when the coil spring 211b is at rest, the lock plate 211a may compress a portion of the needle sub-assembly 214 and prevent rotation of the needle selection gear 204. FIG. 13C shows a plan view of a lateral cross-section of the needle assembly 200' cut through the lock plate 211a when the lock spring 211 is in the locked state, showing a blocking portion 211c of the lock spring 211 that extends into and abuts the surface of a portion of the needle sub-assembly 214 and thus prevents rotation of the needle selection gear 204.FIG. 13D shows a plan view of a cross-section of the needle assembly 200' cut through the transmission gear 206' when the locking spring 211 is in the locked state, showing the lip 203 of the housing 202' that blocks the rotational movement of the transmission gear 206'.
[0046] According to some embodiments of the present technology, when an axial force is applied to the locking spring 211, the locking spring can be moved from the locked position to the unlocked position. The direction of this axial force is indicated by arrow F in FIG. 13B. The axial force can compress the coil spring 211b and enable the axial movement of the lock plate 211a away from preventing the rotation of the needle selection gear 204, and enable the axial movement of the transmission gear 206' away from the lip 203. Thus, it enables the needle selection gear 204 to rotate and also enables the transmission gear 206' to rotate. In some embodiments, the axial force can be applied by a driver gear 602 that can be attached to the cassette housing 22 before or after the dispenser 40 is fully installed within the cassette housing 22. The driver gear 602 can extend through an opening 27b of the cassette housing (see FIGS. 10, 18A, and 18C), apply an axial force to the transmission gear 206', and push the transmission gear 206' in the direction of arrow F away from the lip 203. The transmission gear 206' can then push the lock plate 211a in the direction of arrow F and move the lock plate 211a away from preventing the movement of the needle selection gear 204. In some embodiments, the driver gear 602 can engage with a gear handle 207 (e.g., a slot, a protruding bar, etc.) of the transmission gear 206' to push and / or rotate the transmission gear 206'. The driver gear 602 may include a portion having a shaft configuration, although other gear configurations are contemplated. In some embodiments, the driver gear 602 may be part of a motor assembly, as described below. The cassettes 20, 20' and the motor assembly may be part of a drug delivery device and may be at least partially housed within the housing of the drug delivery device.
[0047] As will be appreciated, by applying a force to the transmission gear 206' in the direction of the arrow F, the needle assembly 200' (and the dispenser 40) can be pushed out of the cassette housing 22. In a related manner, the natural state of the lock spring 210 can prevent the dispenser 10 shown in FIGS. 10, 11A, and 11B from remaining in the fully inserted position (FIG. 11B), and the dispenser 10 can be placed in a partially inserted position (FIG. 11A) within the cassette housing 22 unless a holding force is applied to hold the dispenser 10 in the fully inserted position within the cassette housing 22.
[0048] A latch mechanism can be used to hold the dispensers 10, 40 in a fixed position within the cassette housing 22. According to some embodiments of the present technology, FIGS. 14A-14D and FIGS. 15A-15C show diagrams of a first type of latch mechanism that can be used, and FIGS. 16A-16D and FIGS. 17A-17C show diagrams of a second type of latch mechanism that can be used.
[0049] According to some embodiments of the present technology, the first type of latch mechanism may include a latch 32 configured to engage a latch receiver 220. The latch 32 may be movably attached to a compartment 26' of the cassette housing 22 via a connector 30a. The latch receiver 220 may include a ledge protruding on an outer surface of the housings 202, 202' of the needle assemblies 200, 200'. The latch 32 may include an engaging surface 32a configured to abut against the ledge of the latch receiver 220 to hold the needle assemblies 200, 200' within the compartment 26' when in the latched position, as schematically shown in FIG. 15A. The latch 32 may also include an actuator 30 that can be operated by a user to release the latch 32 from engagement with the latch receiver 220. In some embodiments, the actuator 30 and the latch 32 may be formed as a single structure, and the engaging surface 32a of the latch 32 may be positioned on an inner surface of the structure, while the actuator 30 may be positioned on an outer surface of the structure. In some embodiments, the latch 32 may be disengaged by a user by sliding the actuator 30 in a lateral release direction (or a direction having a lateral component) parallel to the contact surface 34 of the cassette housing 22. For example, FIGS. 14C and 15B show arrows indicating the direction of movement of the actuator 30 for releasing or disengaging the latch 32. In some embodiments, the surface of the actuator 30, the contact surface 34 of the cassette housing 22, and the contact surface 218 of the needle assemblies 200, 200' may be in substantially the same plane such that the actuator 30 cannot be operated in the lateral release direction when the contact surface 218 of the needle assemblies 200, 200' is disposed relative to an injection surface (e.g., the skin surface of a patient into which fluid within the fluid chamber 158 is injected). Such a co-planar structure can advantageously prevent accidental release or disengagement of the latch 32 by a user during the injection process. In some embodiments, the latch 32 and the latch receiver 220 may include complementarily inclined surfaces configured to slide relative to each other during insertion of the instruments of the needle assemblies 200, 200' into the compartment 26' of the cassette housing 22.When the needle assemblies 200, 200' are fully inserted into the compartment 26', the latch 32 can be snap - locked into the latched position as shown in FIG. 15A when the latch receiver 220 drops into the recess of the latch 32 and the engaging surface 32a of the latch 32 abuts against the latch receiver 220. In some embodiments, the connector 30a may be a spring that biases the latch 32, such that when the needle assemblies 200, 200' and the compartment 26' of the cassette housing 22 are in the latched position, the latch 32 remains latched to the latch receiver 220 until the actuator 30 is operated in the lateral release direction as described above. In some embodiments, when the actuator 30 is operated to release or disengage from the latch receiver 220 of the needle assemblies 200, 200', the spring force of the lock springs 210, 211 of the needle assemblies 200, 200' biases the dispensers 10, 40 to eject the dispensers 10, 40 from the cassette housing 22 as shown in FIG. 15C.
[0050] According to some embodiments of the present technology, the second type of latch mechanism may include a latch 32' configured to engage with a latch receiver 220'. The latch 32' may be pivotally attached to a compartment 26'' of the cassette housing 22 via a hinge-type connector (not shown). The latch 32' may include an engagement surface 32a' configured to abut against a ledge of the latch receiver 220' to hold the needle assemblies 200, 200' within the compartment 26'' when in the latched position, as schematically shown in FIG. 17A. The latch 32' may also include an actuator 30' that can be operated by a user to release the latch 32' from engagement with the latch receiver 220. In some embodiments, the actuator 30' may be configured to pivot the latch 32' from the latched position (FIG. 17A) to the released position (FIG. 17B). In some embodiments, the latch 32' may be placed in the released position by a user by sliding the actuator 30' in a lateral direction (or a direction having a lateral component) parallel to the contact surface 34 of the cassette housing 22. For example, FIGS. 16C and 17B show arrows indicating the direction of movement of the actuator 30' to release or disengage the latch 32'. In some embodiments, the surface of the actuator 30', the contact surface 34 of the cassette housing 22, and the contact surface 218 of the needle assemblies 200, 200' may be generally in the same plane such that when the contact surface 218 of the needle assemblies 200, 200' is positioned relative to the injection surface, the actuator 30' cannot be operated to pivot the latch 32' to the released position, preventing accidental release or disengagement of the latch 32' during the injection process. In some embodiments, the actuator 30' may include a spring that biases the actuator 30', such that when the needle assemblies 200, 200' and the compartment 26'' of the cassette housing 22 are in the latched position, the latch 32' remains latched to the latch receiver 220' until the actuator 30' is operated as described above to pivot the engagement surface 32a' of the latch 32' away from the latch receiver 220'.In some embodiments, when the actuator 30' is operated to release or disengage from the latch receiver 220' of the needle assemblies 200, 200', the spring forces of the lock springs 210, 211 bias the dispensers 10, 40 to eject the dispensers 10, 40 from the cassette housing 22, as shown in FIG. 17C.
[0051] According to some embodiments of the present technology, FIG. 18A shows a view of the cassette housing 22 during insertion of the dispenser 10 into the cassette housing 22, and FIG. 18B shows a view after the dispensers 10, 40 are fully inserted into the cassette housing 22. In FIGS. 18A and 18B, a driver gear 502 for rotating the needle selection gear 204 of the needle assembly 200 of the dispenser 10 is disposed in an opening 27a within compartments 26, 26', 26'', through which the driver gear 502 can contact and rotate the needle selection gear 204. In some embodiments, the driver gear 502 may include a portion having a worm gear configuration, although other gear configurations are contemplated. In some embodiments, the driver gear 502 may be part of a driver gear assembly 502A (FIG. 10) comprising at least one other gear, and the driver gear assembly 502A may be incorporated within the housing of the drug delivery device as described herein. FIG. 18C shows an enlarged view of compartments 26, 26', 26'' of the cassette housing 22, showing the teeth of the needle selection gear 204 through the opening 27a. Although not fully visible in FIGS. 18A-18C, an opening 27b is provided in compartments 26, 26', 26'' to allow the above-described driver gear 602 to contact and rotate the transmission gears 206, 206' of the dispensers 10, 40. As described above, in some embodiments, when the dispenser 40 is fully inserted into the cassette housing 22 and the driver gear 602 is attached to the cassette housing 22, the driver gear 602 can apply a force to the transmission gear 206' that can move the lock spring 211 to the unlocked position.
[0052] FIG. 19 shows a block diagram of a motor assembly 50 including a plurality of driver assemblies 400, 500, 600. The motor assembly 50 can be coupled to a controller 700 configured to drive each of the driver assemblies 400, 500, 600. In some embodiments of the present technology, the controller 700 may include at least one computer processor (e.g., a CPU) programmed to control the driver assemblies 400, 500, 600 individually or in cooperation with each other. In some embodiments, the driver assembly 400 may include the above-described driver gear 402 for driving the rotation of the driven mechanism 302 of the drive assembly 300. The driver assembly 400 may include a motor 403 configured to cause the rotation of the driver gear 402. Similarly, in some embodiments, the driver assembly 500 may include the above-described driver gear 502 for driving the rotation of the needle selection gear 204. The driver assembly 500 may include a motor 503 configured to cause the rotation of the driver gear 502. In some embodiments, the driver assembly 600 may include the above-described driver gear 602 for driving the rotation of the transmission gears 206, 206'. The driver assembly 600 may include a motor 603 configured to cause the rotation of the driver gear 602. In some embodiments, the controller 700 may be provided with an actuator (not shown) that enables a user to initiate an injection process.For example, after the user places the cassette at the injection position (e.g., against the user's own skin surface or against the patient's skin surface), the user operates the actuator to cause (1) the needles 216 of the needle assemblies 200, 200' to be positioned in the operative position through the rotation of the needle selection gear 204 via the driver assembly 600, (2) the piston 156 to be moved towards the partition wall 152, e.g., the movement of the drive assembly 300 to discharge a predetermined amount of fluid within the fluid chamber 158 corresponding to the amount of rotation of the driven mechanism 302, and (3) the movement of the transmission gears 206, 206' to move the actuated needle 216 from the retracted position to the injection position and from the injection position to the retracted position, any one or any combination of automated cooperative movements can occur. As described above, the movement of the transmission gears 206, 206' can also enable the partition wall 152 to be perforated and fluid to be discharged into the actuated needle 216.
[0053] As will be appreciated, the cassette housing 22 may have a form different from the form shown in FIG. 10. FIG. 20A shows a view of the cassette 20', where the cassette housing 22' is generally rectangularly shaped and sized to be easily grasped by a user. In some embodiments of the present technology, the cassette housing 22' may have a rounded edge and / or a slightly curved surface as shown. In some embodiments, the cassette housing 22' may have an internal cavity shaped to receive the dispenser 10. For example, the internal cavity of the cassette housing 22' may have a generally cylindrical portion for receiving the cartridge assembly 100 and a compartment 25 shaped to receive the needle assembly 200. FIG. 20B shows a view of the dispenser 10 inserted into the cassette housing 22' to form the cassette 20'. In some embodiments, the cassette housing 22' may be configured with a recess for receiving the driver gear 402. Optionally, a window 22a may be provided in the cassette housing 22' so that the position of the piston 156 and / or the fluid level can be viewed. Although not shown in FIGS. 20A and 20B, the cassette housing 22' may include an opening for the driver gears 502, 602 to contact the needle assembly 200.
[0054] FIG. 21 shows a block diagram of the drug delivery device 1 according to some embodiments of the present technology. In some embodiments, the device 1 may comprise a cassette 20, 20', a motor assembly 50, and a controller 700, some or all of which may be housed within or partially within the housing of the device 1. In some other embodiments, the controller 700 may be external to the housing of the device 1 and may be configured to remotely control the motor assembly 50 through control signals transmitted via a dedicated cable and / or through control signals wirelessly transmitted using known techniques for wireless communication.
[0055] Conclusion It should be understood that various changes, modifications, and improvements can be made to the above-described structure, configuration, and method, and they are intended to be within the spirit and scope of the technology disclosed herein. Further, while the advantages of the technology are shown, it should be understood that not all embodiments of the technology include all of the described advantages. Some embodiments may not implement any of the features described herein as advantageous. Accordingly, the foregoing description and the accompanying drawings are by way of example only.
[0056] It should be understood that some aspects of the technology may be embodied as one or more methods, and the acts performed as part of the method of the technology may be ordered in any suitable manner. Accordingly, even if illustrated and / or described as sequential acts in various embodiments, embodiments can be constructed that include performing some acts simultaneously, or in a different order than that illustrated and / or described.
[0057] The various aspects of the technology can be used alone, in combination, or in various arrangements not specifically described in the foregoing embodiments, and thus, in its application, is not limited to the details and arrangements of the components shown in the foregoing description or illustrated in the drawings. For example, the aspects described in one embodiment can be combined with the aspects described in another embodiment in any manner. Various aspects, including but not limited to the following aspects, are described in the present disclosure.
[0058] In various aspects of the present disclosure, the force transmission portion has a tapered profile and includes at least one drive rib extending radially from the surface of the force transmission portion.
[0059] In various aspects of the present disclosure, at least one drive rib extends a radial distance (d) from the radially outer edge of the drive rib to the longitudinal axis along the axial length of the drive rib.
[0060] In various aspects of the present disclosure, the cartridge housing includes a first section configured to receive at least a portion of an axially extendable portion, a second section configured to receive at least a portion of the cartridge, and a third section configured to align the axially extendable portion and the cartridge.
[0061] In various aspects of the present disclosure, the third section of the cartridge housing includes a housing rib that contacts the proximal end of the cartridge and is configured to position the cartridge relative to the inner wall of the cartridge housing.
[0062] In various aspects of the present disclosure, the housing rib extends radially from the inner wall of the cartridge housing to align the cartridge at a predetermined position within the cartridge housing, and the cartridge abuts against the shoulder portion of the housing rib.
[0063] In various aspects of the present disclosure, the third section of the cartridge housing includes a guide configured to center the axially extendable portion during movement from a retracted position to at least one extended position.
[0064] In various aspects of the present disclosure, the foot is attached to the distal end of the axially extendable portion, the foot is configured to move within the second section of the cartridge housing, the foot includes a foot surface configured to contact the piston surface of the piston to move the piston toward the distal opening of the cartridge, and the foot surface includes a relief structure configured to engage at least one corresponding surface structure on the piston surface.
[0065] In various aspects of the present disclosure, the force transmission portion includes a rotatable spindle engaged with an inner loop of a coil formed in the axially extendable portion and a spline portion configured to receive a spline-shaped force applicator.
[0066] In various aspects of the present disclosure, the spline portion includes a spline-shaped recess configured to receive a spline shaft, and the spline-shaped recess and the rotatable spindle are in a coaxial relationship along the longitudinal axis.
[0067] In various aspects of the present disclosure, the axially extendable portion includes a ribbon, the retracted portion of the ribbon is configured to form a coil, and the ribbon is configured to be controllably unwound and extend in response to an applied force to form a helix having a controllable axial length, and the piston and the helix are coaxial.
[0068] In various aspects of the present disclosure, the force transmission portion includes a plurality of drive ribs extending radially from the surface of the force transmission portion, and the ribbon includes a plurality of rib latches protruding from the first surface of the ribbon, and the rib latches are configured to slidably engage along the drive ribs when the ribbon extends from a retracted position to at least one extended position.
[0069] In various aspects of the present disclosure, the inner surface of the helix includes the first surface of the ribbon, and the second surface of the ribbon includes a groove configured to movably engage and slide along a raised portion of the cartridge housing, and in response to the movement of the ribbon along the raised portion of the cartridge housing and along the drive ribs, the helix is formed into a cylinder having a determined diameter from the ribbon.
[0070] In various aspects of the present disclosure, the ribbon includes meshing elements along its edges, and in some embodiments, includes a plurality of pegs positioned along the first edge of the ribbon and a plurality of holes positioned along the second edge of the ribbon, and as the axially extendable portion extends from a retracted position to at least one extended position, an increasing number of pegs are received in an increasing number of holes so as to interlock to form a cylinder having a determined diameter.
[0071] In various aspects of the present disclosure, the peg is disposed on the first surface of the ribbon, the hole is disposed on the second surface of the ribbon, and the rib latch extends longitudinally between the first and second edges of the ribbon.
[0072] In various aspects of the present disclosure, the ribbon is not confined within the cartridge housing and, when no force is applied to the ribbon, the ribbon is formed of an elastic material such that it forms a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix, and the tapered helix collapses to form a coil when an axial force is applied to the first end, or the second end, or both the first and second ends of the tapered helix, and the axial force is a force along the axis of the tapered helix.
[0073] In various aspects of the present disclosure, the needle assembly is attached to the distal end of the cartridge housing, and the septum is disposed within a recess of the needle assembly.
[0074] In various aspects of the present disclosure, the needle assembly includes a needle assembly housing, a needle movement gear disposed within the needle assembly housing and configured to move the injection needle from a rest position to an injection position, and a gear lock having a non-rotatable lock position for the needle movement gear and an unlock position for rotating the needle movement gear.
[0075] In various aspects of the present disclosure, the needle assembly includes a transmission gear operably coupled to the needle movement gear to cause rotation of the needle movement gear to move the needle, and the gear lock is configured to prevent rotation of the transmission gear when in the lock position.
[0076] In various aspects of the present disclosure, the gear lock includes a spring having a first position corresponding to the lock position of the gear lock and a biasing position corresponding to the unlock position of the gear lock.
[0077] In various aspects of the present disclosure, the cassette housing is configured to accommodate a cartridge assembly and a needle assembly. The cassette housing is composed of tangs. When the needle assembly is not fully inserted into the cassette housing, the spring of the gear lock is in a first position, the gear lock is in a locked position. When the needle assembly is fully inserted into the cassette housing, the tangs of the cassette housing move the spring of the gear lock to a biasing position, enabling the rotation of the transmission gear.
[0078] In various aspects of the present disclosure, the tang is configured to apply a force to the spring to move the spring face of the spring away from a position that restricts the movement of the transmission gear.
[0079] In various aspects of the present disclosure, the needle assembly includes a spring, a lock plate, and a frame post to which the transmission gear is movably attached. When in a first position, the spring and the lock plate are configured to bring the transmission gear into contact with a housing protrusion of the needle assembly housing, and are configured to prevent the transmission gear from being in an engagement position with the needle movement gear. When in a biasing position, the transmission gear is pushed away from contact with the housing protrusion, moving the transmission gear to an engagement position with the needle movement gear, and an axial force is applied to the transmission gear to move the lock plate away from a position that restricts the movement of the transmission gear.
[0080] In various aspects of the present disclosure, the transmission gear includes a handle configured to engage with a rotary driver and be rotated by the rotary driver.
[0081] In various aspects of the present disclosure, the needle movement gear is one of a plurality of needle movement gears disposed within the needle assembly housing, each of the needle movement gears being configured to move a corresponding injection needle between a standby position and an injection position, the needle assembly comprising a selection gear (204) configured to actuate a selected needle movement gear, and in response to the selected needle movement gear moving to an actuation position proximate the transmission gear, the transmission gear being configured to rotate the selected needle movement gear to move the injection needle corresponding to the selected needle movement gear.
[0082] In various aspects of the present disclosure, the gear lock is configured to prevent movement of the selection gear when the gear lock is in the locked position.
[0083] In various aspects of the present disclosure, the cassette housing is configured to house a cartridge assembly and a needle assembly, the cassette housing including a compartment configured to house the needle assembly, a latch configured to engage a latch receiver on the needle assembly to hold the needle assembly within the compartment, and a latch release actuator configured to prevent the latch from disengaging from the latch receiver when the contact surface of the needle assembly is positioned relative to the injection surface.
[0084] In various aspects of the present disclosure, the latch release actuator includes an actuating surface that is configured to be positioned relative to the injection surface when the contact surface of the needle assembly is positioned relative to the injection surface.
[0085] In various aspects of the present disclosure, the latch release actuator is configured to release the latch from engagement with the latch receiver when the force applied to the actuating surface includes a lateral component directed parallel to the contact surface of the needle assembly.
[0086] In various aspects of the present disclosure, the compartment of the cassette housing includes a first opening configured to allow a first driver gear to drive a needle selection gear of the needle assembly, and a second opening configured to allow a second driver gear to drive a movement gear of the needle assembly.
[0087] In various aspects of the present disclosure, the movement gear is a transmission gear configured to cause rotation of the needle movement gear of the needle assembly to move the needle between a retracted position and an injection position.
[0088] In various aspects of the present disclosure, the cassette housing is configured to accommodate a dispenser comprising a cartridge assembly and a needle assembly, the cassette housing including a first opening configured to allow the dispenser to be axially inserted into the cavity of the cassette housing, the cavity comprising a first compartment configured to accommodate the needle assembly and a second compartment configured to accommodate the cartridge assembly, and a second opening configured to allow a motor to rotate a driver assembly.
[0089] In various aspects of the present disclosure, the cassette housing includes a driver gear configured to engage with a driver assembly, the driver gear being configured to transmit a rotational force from a motor to the driver assembly.
[0090] In various aspects of the present disclosure, the dispenser is disposable and removable from the cassette housing, and the cassette housing is reusable with another dispenser.
[0091] In various aspects of the present disclosure, the cassette housing is configured to be attached to a motor assembly comprising at least one motor configured to drive movement in one or both of a drive assembly and a needle assembly.
[0092] In various aspects of the present disclosure, the cassette housing has a generally rectangular shape.
[0093] In various aspects of the present disclosure, the fluid contains a drug, and the cartridge includes a fluid chamber with the drug therein.
[0094] In various aspects of the present disclosure, actuating the needle of the assembly includes changing the gear lock of the needle assembly from a locked state to an unlocked state by the protrusion of the cassette housing exerting a force on the gear lock when the dispenser is fully inserted into the cassette housing.
[0095] In various aspects of the present disclosure, a force is applied to the spring of the gear lock.
[0096] In various aspects of the present disclosure, the force exerted on the gear lock enables the transmission gear to rotate the needle movement gear.
[0097] In various aspects of the present disclosure, the force applied to the gear lock enables the needle selection gear to rotate the needle selector.
[0098] In various aspects of the present disclosure, the cassette housing is reused with a new dispenser by operating the actuator of the latch mechanism of the cassette to unlatch the latch mechanism from the dispenser, removing the dispenser from the cassette housing, fully inserting a new dispenser into the cassette housing, latching the latch mechanism of the cassette housing to the new dispenser to prevent movement of the needle assembly of the new dispenser relative to the cassette housing, and actuating the new dispenser, wherein the operation of the latch mechanism cannot be performed while the contact surface of the cassette housing is in contact with the injection surface, and the contact surface of the cassette housing is coplanar with and surrounds the contact surface of the needle assembly of the dispenser.
[0099] The use of ordinal terms such as "first", "second", "third", etc. in the detailed description and claims to modify an element does not, by itself, imply any priority, precedence, or order of one element with respect to another element, or the temporal order in which acts in a method are performed, but is used only as a label to distinguish one element or act having a particular name from another element or act having the same name (but using a term indicating ordinal number) for the purpose of distinguishing the elements or acts.
[0100] All definitions defined and used herein should be understood to govern the dictionary definition, the definition in the documents incorporated by reference, and / or the ordinary meaning of the defined terms.
[0101] As used herein in the specification and claims, the indefinite articles "a" and "an" should be understood to mean "at least one" unless specifically stated otherwise.
[0102] When used in the specification and claims of this specification, the phrase "at least one" in relation to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, and need not include each and every element specifically listed in the list of elements, nor exclude any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements referred to by the phrase "at least one", whether or not such other elements are related to those specifically identified elements.
[0103] When used in this specification and the claims, the phrases "equal" or "the same" with respect to two values (e.g., distance, width, etc.) mean that the two values are the same within the manufacturing tolerance. Thus, for two values to be equal or the same can mean that the two values differ from each other by up to ±5%.
[0104] In this specification and the claims, the phrase "and / or" as used herein is to be understood to mean "either or both" of the elements so joined, i.e., elements that may be present conjunctively in some cases and disjunctively in other cases. Multiple elements listed using "and / or" are to be construed in the same fashion, i.e., "one or more" of the elements so joined. Other elements other than those specifically identified by the "and / or" clause may optionally be present, whether or not they are related to those specifically identified elements. Thus, by way of non-limiting example, reference to "A and / or B", when used in conjunction with open-ended language such as "comprising", may in one embodiment refer to only A (optionally including elements other than B), in another embodiment refer to only B (optionally including elements other than A), in yet another embodiment refer to both A and B (optionally including other elements), and so on.
[0105] As used in this specification and the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be construed as inclusive. That is, it shall be construed to include not only at least one of a plurality of elements or a list of elements but also a plurality, and optionally, additional items not recited. Terms such as "only one of", "exactly one of", or when used in the claims, "consisting of", etc., are meant to refer to exactly one element of a plurality of elements or a list of elements only when explicitly indicated to the contrary. Generally, as used in this specification, the term "or" shall be construed to indicate an exclusive alternative (i.e., "one or the other but not both") only when followed by exclusive terms such as "either", "one of", "only one of", or "exactly one of". "Consisting essentially of", when used in the claims, shall have the ordinary meaning as used in the field of patent law.
[0106] Also, the syntax and terminology used in this specification are for illustrative purposes and should not be regarded as limiting. The use of "including", "comprising", "comprised of", "having", "containing", "involving", and variations thereof in this specification means to include the items recited thereafter and their equivalents as well as additional items.
[0107] The terms "approximately" and "about", as used herein, may be interpreted to mean within ±20% of a target value in some embodiments, within ±10% of a target value in some embodiments, within ±5% of a target value in some embodiments, and within ±2% of a target value in some embodiments. The terms "approximately" and "about" may be equal to the target value.
[0108] The term "substantially", as used herein, may be interpreted to mean within 95% of a target value in some embodiments, within 98% of a target value in some embodiments, within 99% of a target value in some embodiments, and within 99.5% of a target value in some embodiments. In some embodiments, the term "substantially" may be equal to 100% of the target value.
Claims
**Claim 1** A cartridge assembly (100), comprising a cartridge (150) configured to contain a fluid, a partition wall (152) disposed at a distal opening of the cartridge, a movable piston (156) sealing a proximal opening of the cartridge, the piston being axially movable within the cartridge, and a drive assembly (300) configured to move the piston axially toward the distal opening a cartridge assembly (100); and a needle assembly (200) attached to the cartridge assembly A fluid delivery cassette (20), comprising The drive assembly includes an axially extendable portion (306) having a distal end that is controllably extendable along a longitudinal axis from a retracted position (306a) to at least one extended position (306b), the axially extendable portion being a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix such that the axially extendable portion is foldable to the retracted position, a rotatable force transmission portion (302, 302a) configured to receive an applied force and move the distal end of the axially extendable portion axially in response to the applied force; and A fluid delivery cassette including the above components **Claim 2** The fluid delivery cassette according to claim 1, wherein the force transmission portion has a tapered profile and includes at least one drive rib (302b) extending radially from a surface of the force transmission portion. **Claim 3** The fluid delivery cassette according to claim 1, wherein the at least one drive rib extends a radial distance (d) from a radially outer edge of the drive rib to the longitudinal axis along an axial length of the drive rib. **Claim 4** A cartridge housing (102), comprising a first section (110) configured to receive at least a portion of the axially extendable portion, a second section (108) configured to receive at least a portion of the cartridge, and a third section (112, 114, 114a) configured to align the axially extendable portion and the cartridge. The fluid delivery cassette according to any one of claims 1 to 3, further comprising a cartridge housing (102).
5. Further comprising a foot (304) attached to the distal end of the axially extendable portion, wherein the foot is configured to move within the second section of the cartridge housing, the foot comprising a foot surface configured to contact a piston surface of the piston to move the piston toward the distal opening of the cartridge, The fluid delivery cassette according to claim 4, wherein the foot surface comprises a relief structure (304a) configured to engage at least one corresponding surface structure (156a) on the piston surface.
6. The force transmission portion, a rotatable spindle (302a) engaged with an inner loop of a coil formed in the axially extendable portion, a spline portion (302c) configured to receive a spline-shaped force applicator (404), The fluid delivery cassette according to claim 1, comprising.
7. The fluid delivery cassette according to claim 6, wherein the spline portion comprises a spline-shaped recess configured to receive a spline shaft, and the spline-shaped recess and the rotatable spindle are coaxial along the longitudinal axis.
8. The axially extendable portion includes a ribbon, a retracted portion of the ribbon is configured to form the coil, and the ribbon is controllably unwound and extended in response to the applied force to form a helix having a controllable axial length, the piston and the helix being coaxial, the force transmission portion comprising a plurality of drive ribs (302b) extending radially from the surface of the force transmission portion, the ribbon comprising a plurality of rib latches (306c) protruding from a first surface of the ribbon, The fluid delivery cassette according to claim 6, wherein the rib latch is configured to slidably engage along the drive rib when the ribbon extends from the retracted position to the at least one extended position.
9. The inner surface of the helix includes the first surface of the ribbon, The second surface of the ribbon is provided with a groove (310) configured to movably engage with and slide along the raised portions (111a, 110a, 111a') of the cartridge housing. The fluid delivery cassette according to claim 8, wherein the helix is formed into a cylindrical shape from the ribbon in response to the movement of the ribbon along the raised portion of the cartridge housing and along the drive rib.
10. The ribbon is not confined within the cartridge housing, and when no force is applied to the ribbon, the ribbon is formed of an elastic material so as to form a tapered helix having a diameter that varies from a first end of the tapered helix to a second end of the tapered helix. The fluid delivery cassette according to claim 8, wherein the tapered helix collapses to form a coil when an axial force is applied to the first end, or the second end, or the first and second ends of the tapered helix, and the axial force is a force along the axis of the tapered helix.
11. The needle assembly is attached to the distal end of the cartridge housing. The fluid delivery cassette according to any one of claims 1 to 10, wherein the partition is disposed within a recess of the needle assembly.
12. The needle assembly includes a needle assembly housing (202, 202'), a needle movement gear (208) disposed within the needle assembly housing and configured to move the injection needle (216) from a rest position to an injection position, a gear lock (210, 211) having a lock position where the needle movement gear cannot rotate, and an unlock position where the needle movement gear can be rotated, and the gear lock (210, 211), and the fluid delivery cassette according to claim 11.
13. The needle assembly includes a transmission gear (206, 206') operably coupled to the needle movement gear to cause rotation of the needle movement gear to move the needle. The fluid delivery cassette according to claim 12, wherein the gear lock is configured to prevent rotation of the transmission gear when the gear lock is in the locked position, and the gear lock has a spring bias.
14. A cassette housing (22) configured to accommodate the cartridge assembly and the needle assembly, the cassette housing being composed of a tongue (28), the tongue having a spring bias, further comprising a cassette housing (22), When the needle assembly is not fully inserted into the cassette housing, the spring (210) of the gear lock is in a first position and the gear lock is in the locked position, When the needle assembly is fully inserted into the cassette housing, the tongue of the cassette housing moves the spring of the gear lock to a biasing position, enabling rotation of the transmission gear, according to claim 13 of the fluid delivery cassette.
15. The needle assembly includes a spring (211), a lock plate (211a), and a frame post (212a') to which the transmission gear is movably attached, When in the first position, the spring and the lock plate are configured to contact the transmission gear against a housing protrusion of the needle assembly housing (202'), and the transmission gear is configured to prevent being in an engaged position with the needle movement gear, When in the biasing position, Push the transmission gear away from contact with the housing protrusion, Move the transmission gear to the engaged position with the needle movement gear, and An axial force is applied to the transmission gear to move the lock plate away from a position restricting movement of the transmission gear, according to claim 14 of the fluid delivery cassette.
16. The fluid delivery cassette according to claim 15, wherein the transmission gear includes a handle (207) configured to engage with a rotary driver and be rotated by the rotary driver.
17. The needle movement gear is one of a plurality of needle movement gears disposed within the needle assembly housing, and each of the needle movement gears is configured to move a corresponding injection needle between a standby position and an injection position, The needle assembly includes a selection gear (204) configured to activate a selected needle movement gear, and in response to the selected needle movement gear moving to an operating position proximate to the transmission gear, the transmission gear is configured to rotate the selected needle movement gear to move the injection needle corresponding to the selected needle movement gear. The fluid delivery cassette according to claim 12.
18. The fluid delivery cassette further includes a cassette housing (22) configured to house the cartridge assembly and the needle assembly. The cassette housing has compartments (26, 26', 26'') configured to house the needle assembly, latches (32, 32') configured to engage with latch receivers (220, 220') on the needle assembly to hold the needle assembly within the compartments, and a latch release actuator (30) configured to prevent the latch from disengaging from the latch receiver when the contact surface (218) of the needle assembly is positioned relative to the injection surface. The fluid delivery cassette according to any one of claims 1 to 17.
19. The compartment of the cassette housing has a first opening (27a) configured to enable a first driver gear (502) to drive a needle selection gear (204) of the needle assembly, and a second opening (27b) configured to enable a second driver gear (602) to drive a movement gear (206) of the needle assembly. The fluid delivery cassette according to claim 18.
20. The movement gear is a transmission gear configured to cause rotation of a needle movement gear (208) of the needle assembly to move the needle between a retracted position and an injection position. The fluid delivery cassette according to claim 19.
21. The fluid delivery cassette further includes a cassette housing (22, 22') configured to house a dispenser (10) including the cartridge assembly and the needle assembly. The cassette housing has A first opening configured to allow the dispenser to be axially inserted into the cavity of the cassette housing, the cavity comprising a first compartment configured to accommodate the needle assembly and a second compartment configured to accommodate the cartridge assembly. A second opening configured to allow the motor to rotate the driver assembly. The fluid delivery cassette according to any one of claims 1 to 20, comprising the above. **Claim 22** The fluid delivery cassette according to any one of claims 1 to 21, wherein the fluid contains a drug and the cartridge includes a fluid chamber containing the drug therein. **Claim 23** A fluid delivery cassette according to any one of claims 1 to 22, A reusable cassette housing (22) configured to accommodate at least a portion of the fluid delivery cassette, A reusable motor assembly configured to drive movement within the cartridge assembly, or within the needle assembly, or within both the cartridge assembly and the needle assembly. Comprising: A fluid delivery system (20), wherein the motor assembly is removably attachable to the cassette housing.
Citation Information
Patent Citations
Medical fluid continuous injector
JP1992051966A
Systems and methods for removable syringe micropumps with swirl springs
JP2018536508A
Medical delivery device having an axially expandable drive ribbon
JP2021505246A
Medicament Delivery Device Powered by Volute Spring
US20110184351A1