Injection aid, and method of making and using same

Abstract

An injection aid can include a housing and an actuation assembly within the housing. The housing can be configured to receive a cartridge including a medicament chamber. The housing can include a lid assembly and a base assembly. The lid assembly can be pivotable with respect to the base assembly. The injection aid can include a carriage movably attached to an anchor by two springs extending therebetween. The actuation assembly can be configured to move a plunger relative to the medicament chamber to dispense medicament out of the medicament chamber.

Description

INJECTION AID, AND METHOD OF MAKING AND USING SAMEFIELD

[0001] The presently disclosed technology relates generally to medicament delivery. More particularly, in one embodiment, the presently disclosed technology relates to a reusable injection aid with a drive system to delivery or move high viscosity fluids, such as medicament.BACKGROUND

[0002] Parenteral pharmaceutical therapies employing needle or cannula into the patient through the skin may be delivered by several means for a range of dose volumes. Delivery method and dose volume depend on several factors, such as the target location, the volume and concentration of pharmaceutical product required.

[0003] The volume of fluid influences the method of delivery and time to deliver. At the lower end of the volume range, small doses of 5 mL and under may typically be delivered by injection over a period up to 60 seconds. At the upper end of the volume range, infusion therapies may deliver doses in excess of 30 mL over a period of hours. For some pharmaceutical therapies larger than 5 mL but lower than typically suited to infusion, the dose may be administered by manual injection using a larger volume container, for example a 20 mL container over a period up to 5 minutes, or even more.

[0004] The above-described injections can be delivered using a hypodermic or subcutaneous needle, or in an intramuscular injection, for example. Alternatively, the abovedescribed injections can be delivered subcutaneously using a subcutaneous cannula and infusion line connected to the container. Large volumes of medicament must be delivered at a controlled rate over a moderate period. Current best practice requires a health care provider to deliver these using a manual process, applying a steady pressure to slowly deliver the dose over a period of minutes, e.g., 3-5 minutes or ever longer.

[0005] Manual administrations of the above-described type create several problems. For example, manual injections require manual dexterity and control to maintain a constant controlled rate of injection. Manual injections also require that the health care provider pay close attention and can be time-consuming, which can reduce the efficiency of the health care provider and the clinic in which they work. The sustained pressure and manual manipulation can also cause discomfort to the health care provider, such as hand cramps.SUMMARY

[0006] There is a need for a reusable injection aid that can automatically deliver drug formulation to a patient over a set time period and at a constant flowrate. There is also a need for a device that would replace the manual process and deliver a robust and reliable alternative.

[0007] The above and other needs are addressed by the presently disclosed technology.

[0008] In one aspect, the presently disclosed technology is directed to an injection aid including a housing and an actuation assembly within the housing. The housing can be configured to receive a cartridge including a medicament chamber. The housing can include a lid assembly and a base assembly. The lid assembly can be pivotable with respect to the base assembly. The actuation assembly can include a carriage movably attached to an anchor by two springs extending therebetween. The actuation assembly can be configured to move a plunger relative to the medicament chamber to dispense medicament out of the medicament chamber.

[0009] In another aspect, the presently disclosed technology is directed to an injection aid including a housing configured to receive a cartridge including a medicament chamber. The medicament chamber can be configured to attach to a flexible tubing extending from an interior to an exterior of the housing to deliver medicament to a patient. Two spaced-apart cams can be located within the housing. Each cam can be rotatable with respect to the housing and each other to selective stop a flow of medicament within the flexible tubing by compressing the flexible tubing between the two cams.

[0010] In yet another aspect, the presently disclosed technology is directed to an injection aid including a housing configured to receive a cartridge including a medicament chamber. The housing can include a lid, a base, and a plunger therein. The lid can be pivotable with respect to the base. The lid can include a first window having a striped transparent image thereon or therein. The plunger can be configured to move relative to the medicament chamber to dispense medicament out of the medicament changer. At least a portion of the plunger can include an interlaced image or a plurality of spaced-apart and parallel lines thereon. Movement of the plunger with respect to the lid can create a barrier-grid animation effect through the first window.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The following detailed description of the presently disclosed technology, will be better understood when read in conjunction with the appended drawings, wherein like numerals designate like elements throughout. For the purpose of illustrating the presently disclosed technology, there are shown in the drawings various illustrative embodiments. Itshould be understood, however, that the presently disclosed technology is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0012] Fig. 1 is a perspective view of a device according to an optional aspect of the presently disclosed technology, wherein the device is shown in a first or closed position with a handle thereof shown in a first or extended position;

[0013] Fig. 2 is a perspective view of a portion of the device shown in Fig. 1 , wherein the device is shown in a second or open position with the handle thereof shown in a second or folded position;

[0014] Fig. 3 is a partially exploded perspective view of the device shown in Fig. 1 , wherein a lanyard is shown separated from the device;

[0015] Fig. 4 is a perspective view of certain portions of the device shown in Fig. 1, wherein certain components are shown in a first configuration;

[0016] Fig. 5 is a perspective view of certain portions of the device shown in Fig. 1, wherein the certain components are shown in a second configuration;

[0017] Fig. 5A is a magnified, rotated perspective view of certain portions of the device shown in Fig. 5, wherein a cartridge and a lid assembly are omitted for clarity;

[0018] Fig. 6 is a perspective view of certain portions of the device shown in Fig. 1, wherein the certain components are shown in a third configuration;

[0019] Fig. 7 is a perspective view of certain portions of the device shown in Fig. 1, wherein the certain components are shown in a fourth configuration;

[0020] Fig. 8 is a perspective view of certain portions of the device shown in Fig. 1, wherein the certain components are shown in a fifth configuration;

[0021] Fig. 9 is a perspective view of certain portions of the device shown in Fig. 1, wherein the certain components are shown in a sixth configuration;

[0022] Fig. 10 is a magnified, partially exploded, perspective view of certain portions of a pause mechanism of the device shown in Fig. 1 ;

[0023] Fig. 11 A is a magnified perspective view of certain portions of the device shown in Fig. 1 , wherein a passageway is shown closed because both a control cam and a drive cam are shown in a first or closed position;

[0024] Fig. 1 IB is another magnified perspective view of certain portions of the device shown in Fig. 1, wherein a passageway is shown open because the control cam is shown in a second or open position and the drive cam is shown in the first or closed position;

[0025] Fig. 11C is yet another magnified perspective view of certain portions of the device shown in Fig. 1 , wherein the passageway is shown in the open position because thecontrol cam is shown in the first or closed position and the drive cam is shown in the second or open position;

[0026] Fig. 11C is still another magnified perspective view of certain portions of the device shown in Fig. 1 , wherein a passageway is shown in the open position because both the control cam and the drive cam are shown in the second or open position;

[0027] Fig. 12 is a partially exploded perspective view of a portion of the pause mechanism of the device shown in Fig. 1 ;

[0028] Fig. 13 is a partially exploded perspective view of another portion of the pause mechanism of the device shown in Fig. 1 ;

[0029] Fig. 14 is a perspective view of an underside or interior of a cover or lid assembly of the device shown in Fig. 1 ;

[0030] Fig. 15 is a perspective view of certain portions of the device shown in Fig. 1, wherein interaction between a bow of an adapter and the cams is shown;

[0031] Fig. 16 is a perspective view of certain portions of the device shown in Fig. 1, wherein movement of the drive cam is shown;

[0032] Fig. 17 is a perspective view of the certain portions of the device shown in Fig. 1, wherein a cam control cap is shown within a cradle of the device;

[0033] Fig. 18 is a perspective view of the certain portions of the device shown in Fig. 1 ;

[0034] Fig. 19 is a perspective view of the certain portions of the device shown in Fig. 1;

[0035] Fig. 20 is a perspective view of the certain portions of the device shown in Fig. 1 , wherein an audible dose indicator is shown in a base assembly of the device;

[0036] Fig. 21 is a perspective view of the certain portions of the device shown in Fig. 1, wherein a cartridge is shown in a first or retracted position;

[0037] Fig. 22 is a perspective view of the certain portions of the device shown in Fig. 1 , wherein the cartridge is shown in a second or partially forward position;

[0038] Fig. 23 is a perspective view of the certain portions of the device shown in Fig. 1 , wherein the cartridge is shown in a third or fully forward position; and

[0039] Fig. 24 is a perspective view of the certain portions of the device shown in Fig. 1 , wherein the cartridge is shown in a fourth or partially retracted position.DETAILED DESCRIPTION

[0040] While systems, devices and methods are described herein by way of examples and embodiments, those skilled in the art recognize that the presently disclosed technology is not limited to the embodiments or drawings described. Rather, the presently disclosed technology covers all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims. Features of any one embodiment disclosed herein can be omitted or incorporated into another embodiment.

[0041] Any headings used herein are for organizational purposes only and are not meant to limit the scope of the description or the claims. As used herein, the word “may” is used in a permissive sense (i.e., meaning having the potential to) rather than the mandatory sense (i.e., meaning must). Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

[0042] As used herein, “and / or” means that either or both of the items separated by such terminology are involved. For example, the phrase “A and / or B” would mean A alone, B alone, or both A and B.

[0043] As used herein, “generally” means “in a general manner” relevant to the term being modified as would be understood by one of ordinary skill in the art.

[0044] Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, proximate, distal, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.

[0045] Referring now in detail to the various figures, wherein like reference numerals refer to like parts throughout, Figs. 1-24 show an injection aid, generally designed 10, that separates a drive system thereof from the point or location of medicament injection or delivery to the patient. This allows, in one optional embodiment, for a relatively small patch attachment to the patient, while maintaining a powerful drive system to deliver medicaments of relatively high viscosity. The injection aid 10 can provide a constant injection force over a selected time period to consistently deliver medicament to a patient. The injection aid 10 can be portable, wearable, configured for a tabletop, reusable or designed to be discarded after a single use, and / or is able to generate a high force to deliver medicament of high viscosity.

[0046] Referring to Fig. 3, the injection aid 10 includes a housing 12 configured to receive a cartridge 16 having a barrel that includes a medicament chamber 18 therein. The cartridge 16 can be inserted into the housing 12 prior to injection, and removed from thehousing 12 once the medicament is expelled from the medicament chamber 18. When inserted into the housing 12, the cartridge 16 can be aligned with a plunger 68 such as shown in Fig. 2, so that the two extend along the same axis (e.g., a first axis), and a proximal end of the cartridge 16 is at or near a distal end of the plunger 68.

[0047] Optionally, the cartridge 16 can be sufficiently large to deliver a high volume of medicament. For example, the cartridge 16 can be 20 mL in size, which allows for only a single needle stick to the patient to deliver a full dose. This is in contrast to multiple needle sticks from autoinjectors, which are limited to a 2.25 mL fill volume. The injection can be delivered in any of a variety of ways, such as hypodermic, subcutaneous, or intramuscular. The housing 12 can include a lid assembly 20 and a base assembly 22. The lid assembly 20 can be pivotable with respect to the base assembly 22, as shown in Fig. 2.

[0048] As shown in Figs. 2, 4, 5, 6-9, 11A-11C, and 15, the medicament chamber 18 can be configured to be removably attachable to and / or in fluid communication with a tubing 74 extending from an interior to an exterior of the housing 12 to deliver medicament to a patient. Optionally, the tubing 74 can be flexible and / or transparent, and can extend from the cartridge 16 to the patch attached to the patient.

[0049] As shown in Figs. 1-3, the base assembly 22 can include a handle 23 that is movable between a first or extended position (see Fig. 1) to a second or retracted position (see Figs. 2 and 3). The handle 23 can pivot about an axis (e.g., a second axis) that extends generally or exactly perpendicularly to the first axis and / or a longitudinal axis of the housing 12 or the base assembly 22. As shown in Figs. 2 and 3, the handle 23 can store flush with an exterior surface of the base assembly 22 by complementing a depression within the exterior of the base assembly 22. A lanyard 25 (see Fig. 3) can optionally be adjustable in length and / or can be removably attached to the base assembly 22, such as around the pivot points of the handle 23. Each end of the lanyard 25 can include a key -hole style connector to removably attach to the pivot points of the handle 23.

[0050] Between the lid assembly 20 and the base assembly 22, the housing 12 can include a cradle assembly 24 and a drive assembly or actuation assembly, generally designated 26. As explained in detail below, the actuation assembly 26 can function as a power source for automatically delivering medicament to a patient. One or more spacedapart fasteners 28 can extend through the base assembly 22 and into the cradle 26 to attach the base assembly 22 to the cradle 26 and help secure the drive assembly 26 therebetween. The tubing 74 can extend through a slot 75 in the cradle 24 assembly 25.

[0051] Referring to Figs. 2-9, the actuation assembly 26 can be configured to move theplunger 68 relative to the cartridge 16 and / or the medicament chamber 18 to dispense medicament out of the medicament chamber 18. The actuation assembly 60 can include a carriage 62 moveably attached to an anchor 64 by at least one biasing mechanism, as described in further detail below. The actuation assembly 60 can further include a rail 70 fixed to the base assembly 22. A longitudinal axis of the rail 70 (e.g., a third axis) can extend parallel to a longitudinal axis of the base assembly 22 and / or the first axis. The third axis can be spaced vertically below the first axis, such that the two axes can be within the same plane. The anchor 64 can be movable along the rail 70 and along the third axis. The carriage 62 is movable with or at least temporarily fixed to the anchor 64, and movable with respect to the rail 70 and / or the base assembly 22 along the third axis.

[0052] In one embodiment, the biasing mechanism can include two springs 66a, 66b (spring 66b shown in Fig. 5A) extending between and attached to the carriage 62 and the anchor 64. The two springs 66a, 66b are configured to bias the carriage 62 toward the anchor 64 when the lid assembly 20 is in a closed position with respect to the base assembly 22 to gradually pull the carriage 62 toward the anchor 64.

[0053] Optionally, each of the two springs 66a, 66b is a constant force spring that are arranged in a front-to- front orientation on opposing lateral sides of the carriage 62 and the anchor 64. The phrase front-to-front orientation refers to the configuration shown in Fig. 5A, where exposed interior surfaces of the two springs 66a, 66b face each other on opposing sides of an axis that extends parallel to the third axis. The springs 66a, 66b can be spaced-apart in a direction that is perpendicular to the longitudinal axis of the rail 70 (e.g., the third axis) and parallel to the axis about which the handle 23 rotates (e.g., the second axis).

[0054] Each spring 66a, 66b can optionally be a 15 Newton (N), 25 N, or 35 N spring, or between 15-35 N. The use of constant force springs results in a constant output force (and hence flow rate) that does not decay as the plunger 68 moves. Testing has shown that a front- to-front orientation provides an improved efficiency compared to an over / underhand arrangement or a single spring arrangement. An over / underhand arrangement can be where one spring is above another (e.g., above and below a horizontally extending longitudinal axis) and spaced-apart in a direction that is perpendicular to both the first and third axes. It is possible to change out or replace the springs 66a, 66b with springs of different forces. However, in one embodiment, it can be beneficial that both sides have the same force to enable smooth or proper movement of the actuation assembly 26.

[0055] Optionally, at least one link or linkage connects the lid assembly 20 to the anchor 64. More particularly, two laterally spaced-apart linkages 72a, 72b connect the lid assembly20 to the anchor 64. Each linkage 72a, 72b can extend parallel to the first axis. One end of each linkage 72a, 72b can be pivotally attached to an interior of the lid assembly 20, and an opposing end of each linkage 72a, 72b can be pivotally attached to the anchor 64. As shown in Figs. 2 and 3, each linkage 72a, 72b can extend through an elongated slot 73a, 73b in the cradle assembly 24. Moving the lid assembly 20 to a closed position with respect to the base assembly 22 moves the anchor 64 along the rail 70 away from the carriage 62. More particularly, the springs 66a, 66b can be charged or primed by closing the lid assembly 20.

[0056] Operation of one embodiment of the actuation assembly 26 is as follows. When moving the lid assembly 20 to the open position shown in Fig. 4, the linkages 72a, 72b pull the anchor 64 and the carriage 62 to a rear of the rail 70. In this configuration, the springs 66a, 66b are extended slightly. Since the anchor 64 and the carriage 62 are in contact, there is no relative movement between the anchor 64 and the carriage 62. In this position, the plunger 68 is pulled back sufficiently to allow for the cartridge 16 to be loaded into and / or unloaded from the housing 12 and / or the cradle assembly 24.

[0057] When closing the lid assembly 20 as shown in Fig. 5, the linkages 72a, 72b begin to push the anchor 64 to or toward the front of the rail 70. This movement of the anchor 64 pulls the carriage 62 and the plunger 68 by the springs 66a, 66b until contact between the plunger 68 and a stopper 17 of the cartridge 16 is made. The linkages 72a, 72b continue to push the anchor 64 forward, thereby extending the springs 66a, 66b as the gap or spacing between the carriage 62 and the anchor 64 widens.

[0058] Once contact between the plunger 68 and stopper 17 is made, resistive forces of the stopper (e.g., friction) and the medicament inside the cartridge 16 (e.g., pressure) resist forward movement of the carriage 62 so that the anchor 64 separates from the carriage 62. The springs 66a, 66b have a biasing force that overcomes the resistive forces to allow the plunger 68 to move at a desired speed, thereby delivering the medicament at a desired flow rate.

[0059] As shown in Fig. 6, when the lid assembly 20 is in the fully closed position, the linkages 72a, 72b push the anchor 64 to or near the front of the rail 70. This positioning fully extends the springs 66a, 66b, and therefore pulls the carriage 62 and the plunger 68 by the force of the springs 66a, 66b. As the carriage 62 is gradually pulled toward the anchor 64, the plunger 68 pushes the stopper 17 of the cartridge 16 and expels the fluid or medicament therein through the front end of the cartridge 16. The linkages 72a, 72b maintain the anchor 64 at or near the front of the rail 70. In this position, the anchor 64 continues to pull the carriage 62 and the plunger 68 toward the anchor 64 by the force of the springs 66a, 66b.This force continues to push the stopper 17 of the cartridge 16 to expel the medicament. The actuation assembly 26 continues to expel the medicament from the medicament chamber 18 until none is left therein.

[0060] As shown in Fig. 7, in the end or completed position, a gap or spacing exists between the carriage 62 and the anchor 64. As a result, force is still being applied to the stopper 17 of the cartridge 16. However, the carriage 62 and the plunger 68 are no longer moving because the stopper 17 is incompressible.

[0061] When the injection is complete, the lid assembly 20 can be pivoted with respect to the base assembly 22 to an open position, as shown in Fig. 8. Opening the lid assembly 20 begins to retract the anchor 64 until it contacts the carriage 62. Further opening of the lid assembly 20 pulls the anchor 64 and the carriage 62 backwards on the rail 70.

[0062] As shown in Fig. 9, when the lid assembly 20 is in a fully open position with respect to the base assembly 22, the anchor 64 and the carriage 62 are retracted or pulled back to near or at the rear of the rail 70. In this configuration, the spent cartridge 16 can be removed from the housing 12 and / or the cradle assembly 24 and replaced.

[0063] In one optional embodiment, the injection aid 10 can include a pause mechanism, which can allow a user (e.g., a health care provider and / or a patient) to selectively pause or stop the flow of medicament through the tube 74. The pause mechanism can optionally include two spaced-apart cams 76a, 76b can be located within the housing 12. More particularly, as shown in Fig. 10, the cams 76a, 76b can be housed within a sub-assembly 86 attached to an underside to the cradle assembly 24. The cams 76a, 76b can be configured to prevent premature actuation, as described in detail below.

[0064] Referring to Figs. 11 A-l ID, each cam 76a, 76b can be rotatable with respect to the housing 12 and / or the sub-assembly 86, and each other, to selectively pause or stop the flow of medicament within the tubing 74 by compressing the tubing 74 between the two cams 76a, 76b. Each cam 76a, 76b is rotatable about an axis perpendicular to an axis (or axes) about which the lid assembly 20 rotates. A first one of the cams can be referred to herein as control cam 76a, and a second one of the cams can be referred to herein as drive cam 76b.The pause mechanism can be configured such that both cams must be closed to stop or pause fluid flow within the tubing 74. If one or both of the cams 76a, 76b are in an open position, then fluid can flow through the tubing 74.

[0065] For example, Fig. 11 A shows the scenario where both cams 76a, 76b have been rotated inward and / or to a closed position, such that no fluid can flow through the tubing 74. Figs. 1 IB shows the scenario where the control cam 76a has been rotated outward and / or toan open position and the drive cam 76b has been rotated inward and / or to the closed position. In the scenario shown in Fig. 11, the control cam 76a has been rotated inward and / or to the closed position, and the drive cam 76b has been rotated outward and / or to the open position. Fig. 1 ID shows the scenario where both cams 76a, 76b have been rotated outward and / or to the open position. In each of the configurations shown in Figs. 1 IB-1 ID, fluid can flow through the tubing 74.

[0066] Thus, in one embodiment, the system is designed such that both cams 76a, 76b must be in the closed position to stop fluid flow. If one or both cams 76a, 76b are in the open position, then fluid can flow through the tubing 74.

[0067] In one optional embodiment, the user can control the pause mechanism through a mechanism, such as a dial 80. For example, referring to Figs. 1, 3, 13, 14, 18, and 19, the lid assembly 20 can include a dial 80 operatively connected to and configured to rotate the control cam 76a between its open and closed positions. Optionally, the dial 80 can be turned or rotated 90 degrees between an open position (see Fig. 1), wherein fluid is permitted to flow through the tubing 74, and a closed position (see Fig. 3), wherein fluid is prevented from flowing through the tubing 74 when the lid assembly 20 is in the closed position.

[0068] Referring to Figs. 12 and 19, each cam 76a, 76b can optionally be attached to a biasing member 78a, 78b, such as a torsion or coil spring. One of the biasing members 78a can bias the respective cam 76a to a closed position with respect to the flexible tubing 74 and the other of the biasing members 78b can bias the respective cams 76b to an open position with respect to the flexible tubing 74. More specifically, the control cam 76a defaults or is biased to the closed position due to the biasing member 78 a, and the drive cam 76b defaults or is biased to the open position due to the biasing member 78b. This allows the default system state to be open when the lid assembly 20 is open, and closed (e.g., paused or stopped) when the lid assembly 20 is closed, as described in further detail below. The abovedescribed arrangement allows for a direct hydraulic pause of the fluid flow through application of a clamping force on the infusion line or tubing 74, and allows for near instantaneous pause of fluid flow compared to mechanism based pause designs of the prior art.

[0069] As shown in Fig. 13, the dial 80 can be connected to a biasing member 88, such as a torsion spring, configured to bias, return, or rotate the dial 80 to a default state or position (e.g., the closed position). As shown in Figs. 13 and 14, a projection or pin 90 extending through a slot 92 of the lid assembly 20 can be operatively connected to the dial 80 and can extend beyond an interior surface of the lid assembly 18. A distal end of the pin 90 canengage the control cam 76a, or a slot of a cap 77 (see Fig. 2) thereof. Thus, rotation of the dial 80 can rotate the control cam 76a. When the lid assembly 20 is open, the dial 80 and the pin 90 do not engage the control cam 76a or the slot of the cap 77. When the lid assembly 20 is open, the control cam 76a is closed and the drive cam 76b is open (e.g., see Fig. 11C), which allows the system state to be open when the lid is open, and closed (e.g., paused or stopped) when the lid assembly 20 is closed.

[0070] As shown in Fig. 16, the drive cam 76b can be rotated from the open position to the closed position by movement of the lid assembly 20 from the open position to the closed position with respect to the base assembly 22. Thus, closing the lid assembly 20 has the effect of closing the drive cam 76b and putting the injection aid 10 into a paused stated. More particularly, as previously described, closing the lid assembly 20 moves or pushes the anchor 64 toward or to the front of the rail 70. An extension or rib 96 on a front or distal end of the anchor 64 can be sized, shaped, and / or configured to push a protrusion or flag 79 of the drive cam 76b. Contact between the rib 96 and the flag 79 can cause the drive cam 76b to turn or rotate from the open position to the closed position. The drive cam 76b is held in the closed position by the rib 96 as long as the lid assembly 20 is in the closed position.

[0071] To help maintain the lid assembly 20 in the closed position with respect to the base assembly 22, two or more magnets can be included in various portions of the device. For example, the base assembly 22 or the cradle assembly 24 can include one or more magnets 48 that can be configured to be attracted to one or more magnets within the lid assembly 20. Optionally, one or more magnets 48 can be two spaced-apart magnets embedded in the sub-assembly 86 (see Fig. 10).

[0072] Referring to Figs. 4, 8, and 15, an adapter 94 can improve the functionality and usability of the pause mechanism. The adapter 94 can be in the form of or include a bow that ensures that there is always a straight section of tubing 74, free from obstruction onto which the cams 76a, 76b can act. The bow can extend above and parallel to at least a portion of the tubing 74 so as to provide access to the tubing 74 while also holding the second of tubing 74 is a straight configuration. Optionally, the adapter 94 can be keyed so that it can be assembled in only one orientation. One or more arms on a proximal end thereof can flex to receive a portion of the cartridge 16 therein to fluidly connect the cartridge 16 to the tubing 74. At least a portion of the adapter 94 can be sized, shaped, and / or configured to fit within the slot 75 of the cradle assembly 24.

[0073] Fig. 17 shows a top view of the cradle assembly 24 if the closed lid assembly 20 is hidden from view for clarity purposes only. Portions of each the drive cam 76b and thecontrol cam 76a can extend into the slot 75 of the cradle assembly 24 when the lid assembly 20 is in the closed position. These portions of the drive cam 76b and the control cam 76a would compress the tubing 74 if it extended therebetween. In contrast, when the lid assembly 20 is in the open position, the drive cam 76b is in the open position. So even with a portion of the control cam 76a extending into the slot 75 of the cradle assembly 24, there is sufficient room to load the cartridge 16 with the adapter 94 into the cradle assembly 24.

[0074] In order to start the medicament delivery, the user rotates the dial 86 from the closed position shown in Fig. 3 to the open position shown in Fig. 1. Turning the dial 86 turns the pin 90. The pin 90 engages the cap 77 of the control cam 76a, and turns the control cam 76a from the closed position in which it is biased (see, e.g., Fig. 11 A) to the open position (see, e.g., Fig. 1 IB). Moving the dial 86 back to the closed position shown in Fig. 3 moves the control cam 76a back to the closed position and pauses or stops medicament flow through the tubing 74 when the lid assembly 20 is in the closed position.

[0075] Because the default or biased position of the control cam 76a is closed, it can be helpful to include a mechanism or feature to hold the control cam 76a in the open position until the end of the medicament delivery or until the user manually pauses the device (e.g., through rotation of the dial 86). Otherwise, the biasing member 78a connected to the control cam 76a would rotate the control cam 76a to the closed position. As shown in Figs. 18 and 19, a spring plunger or holding mechanism 98 can be fitted to the control cam 76a. Optionally, the holding mechanism 98 can be cylindrical in shape and can include external threads configured to threadably mate with internal threads of a portion of the control cam 76a. The holding mechanism 98 can be removably inserted into and can extend through a portion of the control cam 76a.

[0076] Fig. 18 shows the control cam 76a in the closed position, and Fig. 19 shows the control cam 76a in the open position. A top surface of the anchor 64 can include a depression 100. A bottom surface of the holding mechanism 98 can complementarity engage the depression 100. When the control cam 76a is rotated to the open position, a lower surface of the holding mechanism 98 is caught or held by the depression 100. The connection or friction force between the holding mechanism 98 and the depression 100 can be overcome by rotating the dial from the open position to the closed position.

[0077] Referring to Figs. 20-24, the injection aid 10 can alert the user at or near the end of medicament delivery (e.g., when the plunger 68 has pushed all or most of the medicament out of the medicament cavity 18 of the cartridge 16). In one optional embodiment, an audible indicator or alert can be in the form of a bell 50 located within the housing 12, and optionallybeneath the rail 70. The housing 12 can also include a striker arm 52 operatively connected to a biasing member 54. The biasing member 54 can be in the form of a coil spring. In operation, the striker arm 52 can be released and biased to strike the bell 50 at or near the end of medicament delivery. The contact between the released striker arm 52 and the bell 50 can produce a single audible chime or ring.

[0078] As shown in Figs. 21-24, a catch 55 on an underside of the carriage 62 can be used to charge and / or release the striker arm 52. The catch 55 can be pivotable with respect to the carriage 62, and can engage or pick-up on a raised boss 56 on the striker arm 52. The catch 55 can be operatively connected to a biasing member. The catch 55 can rotate and retract when passing back over the striker arm 52 during reset of the audible indicator.

[0079] Fig. 21 shows that at the start of medicament delivery, the carriage 62 and plunger 68 are located at or near a (proximal) end of the rail 70. The catch 55 is shown in Fig. 21 in a default, biased, or lowered position, and the striker arm 52 is shown in the starting or retracted position. In this configuration, the striker arm 52 is in tension by the biasing member 54.

[0080] Fig. 22 shows the carriage 62 and the plunger 68 moved forward along the rail 70. In this configuration, the catch 55 moves through a space or gap until the catch 55 picks-up or contacts the boss 56 protruding from the striker arm 52. As the carriage 62 and the plunger 68 move further forward along the rail 70, the catch 55 drags the striker arm 52 forward, rotating it around its pivot point, and further extending the biasing member 54.

[0081] Referring to Fig. 23, at the point at which the carriage 62 and the plunger 68 are at or near the end of medicament delivery, the catch 55 fully passes over and releases the boss 56 on the striker arm 52. The stored energy in the biasing member 54 pulls the striker arm 52 back sharply or quickly. This causes a tip or other portion of the striker arm 52 to strike or contact the bell 50, causing a sharp, audible charm or ring.

[0082] When the lid assembly 20 is opened (e.g., following medicament delivery), the carriage 62 and the plunger 68 move back toward the proximal end of the rail 70, as shown in Fig. 24. The catch 55 is able to rotate upward in this direction of travel, so that the catch 55 can pass freely over the boss 56 on the striker arm 52. This allows the injection aid 10 to be in position for another chime to be produced after another medicament delivery.

[0083] In the same or an alternative embodiment, referring to Figs. 1, and 3, the lid assembly 20 can include a visual indicator and / or visual amplifier of plunger 68 movement with respect to the housing 12 and / or the cartridge 16. For example, in one optional embodiment, the top surface of the lid assembly 20 can include a first window 82 spaced-apart from a second window 84. The first window 82 can optionally be smaller or have a shorter length than the second window 84. The second window 84 can be located between the first window 82 and the dial 80 along the longitudinal axis of the housing 12.

[0084] To provide the visual indication, the first window 82 can include a striped and / or at least partially transparent image thereon or therein. The second window 84 can be transparent without a striped image. At least a portion of the plunger 68 can include an interlaced image or a plurality of spaced-apart and parallel lines thereon, such as that shown in Figs. 3-5. Movement of the plunger 68 beneath and / or within respect to the lid assembly 20 creates a barrier-grid animation or picket fence animation effect through the first window 82, as the interlaces image or the plurality of spaced-apart and parallel lines of the plunger 68 pass beneath the striped image of the first window 82. This allows the user to determine at a quick glance if the injection aid 10 is still delivering medicament or if delivery has completed. This allows for the relatively slow moving plunger 68 to appear as if it is moving more quickly because of the optical illusion created.

[0085] In operation, a free end of the tubing 74 (e.g., opposite the patch) can be connected at a distal end of an unused or unspent cartridge 16 full of or containing medicament. This can optionally be accomplished by pressing an end of the adapter 94 against the cartridge 16 such that the arms of the adapter 94 expand slightly around exit end of the cartridge 16 and then clamp onto the cartridge. The lid assembly 20 can be pivoted to an open position with respect to the base assembly 22, and the cartridge 16 can be inserted into a receptacle of, or attached to, the cradle assembly 24. The tubing 74 can be fed through the slot 75 of the cradle assembly 24, with the bow portion of the adapter 94 sitting at least partially in, or above, the slot 75. Once the patch has been attached to the patient, the lid assembly 20 can be moved to the closed position with respect to the base assembly 22. Once the dial 80 has been rotated to the open position (see Fig. 1), medicament will begin to flow from the cartridge 16, where the plunger 68 pushes the stopper 17 toward the exit end of the cartridge 16, through the tubing 74, and to the patch.

[0086] The following exemplary embodiments further describe optional aspects of the presently disclosed technology and are part of this Detailed Description. These exemplary embodiments are set forth in a format substantially akin to claims (each with numerical designations followed by a capital letter), although they are not technically claims of the present application. The following exemplary embodiments refer to each other in dependent relationships as “embodiments” instead of “claims.”

[0087] 1A. A method of stopping medicament flow from an injection aid, themethod comprising: rotating a dial on an exterior surface of a lid assembly of the injection aid, which in turn rotates a control cam beneath the lid assembly to a closed position; and rotating a lid assembly of the injection aid to a closed position with respect to a base assembly of the injection aid, which in turn rotates a drive cam beneath the lid assembly to a closed position.

[0088] 2 A. The method embodiment 1A, wherein a flexible tubing extends between the control cam and the drive cam.

[0089] 3A. The method according to embodiment 2A, each cam rotates about an axis extending perpendicularly to an axis about which the lid assembly rotates.

[0090] IB. A method of permitting medicament flow from an injection aid, the method comprising: rotating a lid assembly of the injection aid to a closed position with respect to a base assembly of the injection aid; and rotating a dial on an exterior surface of a lid assembly of the injection aid, which in turn rotates a control cam beneath the lid assembly to an open position.

[0091] 2B. The method according to embodiment IB, wherein the injection aid includes a drive cam spaced-apart from the control cam.

[0092] While the presently disclosed technology has been described in detail and with reference to specific examples thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof. It is understood, therefore, that the presently disclosed technology is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the presently disclosed technology.

Claims

CLAIMSWhat is claimed is:

1. An injection aid comprising: a housing configured to receive a cartridge including a medicament chamber, the housing including a lid assembly and a base assembly, the lid assembly being pivotable with respect to the base assembly; and an actuation assembly within the housing, the actuation assembly including a carriage movably attached to an anchor by two springs extending therebetween, the actuation assembly being configured to move a plunger relative to the medicament chamber to dispense medicament out of the medicament chamber.

2. The injection aid of claim 1, wherein the two springs bias the carriage toward the anchor to gradually pull the carriage toward the anchor when the lid assembly is in a closed position with respect to the base assembly.

3. The injection aid of any previous claim, wherein the actuation assembly includes a rail fixed to the base assembly, and wherein the anchor and the carriage are each movable along the rail.

4. The injection aid of claim 3, wherein at least one linkage connects the lid assembly to the anchor, and wherein moving the lid assembly to a closed position with respect to the base assembly moves the anchor along the rail away from the carriage.

5. The injection aid of any previous claim, wherein each of the two springs is a constant force spring.

6. The injection aid of any previous claim, the two springs are arranged in a front-to-front orientation on opposing sides of the anchor and the carriage.

7. The injection aid of any previous claim, wherein the cartridge is movable with the carriage.8 An injection aid comprising:a housing configured to receive a cartridge including a medicament chamber, the medicament chamber being configured to attach to a flexible tubing extending from an interior to an exterior of the housing to deliver medicament to a patient, two spaced-apart cams located within the housing, each cam being rotatable with respect to the housing and each other to selective stop a flow of medicament within the flexible tubing by compressing the flexible tubing between the two cams.

9. The injection aid of claim 8, wherein each cam is attached to a coil spring, wherein one of the cams is biased to a closed position by the respective coil spring and the other of the cams is biased to an open position by the respective coil spring.

10. The injection aid of claim 8 or 9, wherein the housing includes a lid assembly pivotable with respect to a base assembly, the lid assembly include a dial on an exterior thereof, the dial being operatively connected to one of the two spaced-apart cams to rotate the cam between the open position and the closed position.

11. The injection aid of claim 10, wherein the dial is operatively connected to a biasing member, and wherein the dial is rotatable between two positions 90 degrees apart.

12. The injection aid of claim 10, wherein the other of the two spaced-apart cams is configured to be rotated from the open position to the closed position by movement of the lid assembly from an open position to a closed position with respect to the base assembly.

13. The injection aid of claim 8, wherein housing includes a lid assembly pivotably attached to a base assembly, wherein fluid is permitted to flow through the flexible tubing when the lid assembly is in an open position, wherein fluid is prevented from flowing through the flexible tubing when the lid assembly is in a closed position.

14. The injection aid of claim 13, wherein each cam is rotatable about an axis perpendicular to an axis about which the lid assembly rotates.

15. An injection aid comprising: a housing configured to receive a cartridge including a medicament chamber, the housing including a lid, a base, and a plunger therein, the lid being pivotable with respect tothe base, the lid including a first window having a striped transparent image thereon or therein, the plunger being configured to move relative to the cartridge to dispense medicament out of the medicament changer, at least a portion of the plunger including an interlaced image or a plurality of spaced-apart and parallel lines thereon, wherein movement of the plunger within respect to the lid creates a barrier-grid animation effect through the first window.

16. The injection aid of claim 15, wherein the lid further includes a second window spaced-apart from the first window, the second window being transparent, the second window being larger than the first window.

17. The injection aid of claim 16, wherein the medicament chamber is visible through the second window when the lid is in a closed position with respect to the base.

18. The injection aid of any one of claims 15-17, wherein a flexible tubing is attached to the cartridge, wherein fluid is permitted to flow through the flexible tubing when the lid is in an open position, wherein fluid is prevented from flowing through the flexible tubing when the lid is in a closed position.

19. The injection aid of any one of claims 16-18, wherein the second window is devoid of a striped transparent image thereon or therein.

20. The injection aid of any one of claims 15-19, wherein the barrier-grid animation effect visually amplifies slow movement of the plunger within the housing.

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