MEDICATION INJECTION DEVICE AND METHOD
TECHNICAL FIELD
[0001] The present disclosure generally relates to injection devices for dispensing medicament to a patient and more particularly to injection devices including components for setting and delivering one or more selected doses from a medication cartridge.
BACKGROUND
[0002] Injectable drugs and biologic agents are employed to treat various diseases, disorders, trauma and/or conditions. For example, in patients with a diabetic condition, injectable drugs and biologies are used in an attempt to treat and avoid complications associated with diabetes such as high blood pressure, kidney disease, nerve damage, heart disease and/or blindness. These injectable drugs and biologies can be administered to a patient with caregiver assistance or self-administration with drug delivery devices.
[0003] Drug delivery devices can provide single or set doses of a drug, biologic and/or agent from a cartridge containing an amount of the drug, biologic and/or agent for preparation of therapeutic doses. Drug delivery devices may be variously configured including disposable pre-filled syringe devices, which may be user actuated, gear driven, spring actuated, electronic and/or automatic. In some cases, drug delivery devices include a disposable and/or reusable pen device that allow a diabetic patient to inject successive measured doses of insulin solution. These types of pen devices can be configured to administer one or more set doses, and enable a patient or caregiver to set a measured dose, correct the dose amount if necessary, and inject the dose. These pen devices can also provide feedback to a user during dose set, correction and/or dose dispensing. This disclosure describes an improvement over these prior technologies. SUMMARY
[0004] In one example, a medication delivery device is provided. The medication delivery device includes a housing and a first drive member including at least one arm having a tooth. A nut includes at least one tooth, and the at least one tooth of the nut includes a first face and a second face. The tooth of the first drive member is engageable with the first face during dose dispensing to allow rotation of the first drive member relative to the housing and the second face during dose setting to prevent rotation of the first drive member relative to the housing. Systems and methods of use are also disclosed.
[0005] In one example, the medication delivery device includes a housing and a first single arm ratchet having a tooth including an arcuate face. A dose member includes inner teeth engageable with the tooth to provide audible and/or tactile feedback during dose setting.
[0006] In one example, the medication delivery device includes a housing and a first single arm ratchet having a tooth including an arcuate face. A first drive member includes inner teeth engageable with the at least one tooth to provide audible and/or tactile feedback during dose correction.
[0007] In one example, the medication delivery device includes a housing and a dose button. A double ratchet has an upper ring including a first single arm ratchet having a tooth including an arcuate face and a lower ring including a second single arm ratchet having a tooth including an arcuate face. A dose sleeve includes inner teeth engageable with the tooth of the upper ring to provide audible and/or tactile feedback during dose setting. A drive sleeve includes inner teeth engageable with the tooth of the lower ring to provide audible and/or tactile feedback during dose correction. A non-return drive sleeve is keyed with the drive sleeve and includes at least one arm having a tooth. A nut includes at least one tooth having a first face defining an arc and a second face. In some non-limiting emboidments the arc may have a uniform radius. The tooth of the non-return drive sleeve is engageable with the first face during dose dispensing to allow rotation of the drive sleeve relative to the housing and the second face during dose setting to prevent rotation of the drive sleeve relative to the housing. The medication delivery device includes a leadscrew and a medication cartridge including a piston.
[0008] In one example, the medication delivery device includes a housing, a non-return drive sleeve including at least one arm having a tooth; and a nut including at least one tooth. The at least one tooth of the nut includes a first face and a second face. During dose dispensing, the tooth of the first drive member is engageable with the first face to define a torque gradient that decreases linearly such that the first drive member is allowed to rotate relative to the housing. During dose setting, the tooth of the first drive member is engageable with the second face to prevent rotation of the first drive member relative to the housing and prevent back driving of one or more components of the medication delivery device.
[0009] In one example, the medication delivery device includes a housing defining a longitudinal axis. A non-return drive sleeve includes a first circumferential arm having a tooth, a second circumferential arm having a tooth and a third circumferential arm having a tooth. The arms are approximately equidistantly spaced about the non-return drive sleeve. A nut includes at least one tooth. The arms are configured for disposal with the nut such that the non-return drive sleeve is coaxially aligned with the housing. During dose dispensing, the teeth of the non-retum drive sleeve are engageable with the at least one tooth of the nut such that the first drive member is allowed to rotate relative to the housing. During dose setting, the teeth of the non-retum drive sleeve are engageable with the at least one tooth of the nut to prevent rotation of the first drive member relative to the housing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:
[0011] FIG. 1 is a perspective view of components of one example of a medication delivery device in accordance with the principles of the present disclosure;
[0012] FIG. 2 is a cross section view of the components shown in FIG. 1 ;
[0013] FIG. 3 is a cross section view of the components shown in FIG. 1 ; [0014] FIG. 4 is a perspective view of the components shown in FIG. 1 with parts separated;
[0015] FIG. 5 is a break away view of the components shown in FIG. 3;
[0016] FIG. 6 is a break away view of the components shown in FIG. 3;
[0017] FIG. 7 is a perspective view of components of the device shown in
FIG. 1 ;
[0018] FIG. 8 is a break away view of the components shown in FIG. 3;
[0019] FIG. 9 is a perspective view of components of the device shown in
FIG. 1 ;
[0020] FIG. 10 is a perspective view of components of the device shown in FIG. 1 ;
[0021] FIG. 11 is a cutaway view of components of the device shown in FIG. 1 ;
[0022] FIG. 12 is an enlarged view of detail A shown in FIG. 11 ;
[0023] FIG. 13 is an enlarged break away view of components of the device shown in FIG. 1 ;
[0024] FIG. 14 is a perspective view of components of the device shown in
FIG. 1 ;
[0025] FIG. 15 is a perspective view of components of the device shown in
FIG. 1 ;
[0026] FIG. 16 is a perspective view of components of the device shown in
FIG. 1 ;
[0027] FIG. 17 is an enlarged break away view of components of the device shown in FIG. 1 ;
[0028] FIG. 18 is an enlarged break away view of components of the device shown in FIG. 1 ;
[0029] FIG. 19 is an enlarged break away view of components of the device shown in FIG. 1 ;
[0030] FIG. 20 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIG. 1 ; [0031] FIG. 21 is an enlarged break away view of components of one example of a medication delivery device in accordance with the principles of the present disclosure;
[0032] FIG. 22 is an enlarged break away view of components of one example of a medication delivery device in accordance with the principles of the present disclosure;
[0033] FIG. 23 is an enlarged break away view of components of one example of a medication delivery device in accordance with the principles of the present disclosure;
[0034] FIG. 24 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIG. 21 ;
[0035] FIG. 25 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIG. 22;
[0036] FIG. 26 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIG. 23;
[0037] FIG. 27 is a plan view of components of one example of a medication delivery device in accordance with the principles of the present disclosure;
[0038] FIG. 28 is a plan view of components of one example of a medication delivery device in accordance with the principles of the present disclosure;
[0039] FIG. 29 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIGS. 27 and 28;
[0040] FIG. 30 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIG. 28;
[0041] FIG. 31 is a graphical representation of performance characteristics of components of the medication delivery device shown in FIG. 29;
[0042] FIG. 32 is a perspective view of components of the medication delivery device shown in FIG. 1 ;
[0043] FIG. 33 is a perspective view of components of the medication delivery device shown in FIG. 1 ;
[0044] FIG. 34 is a perspective view of components of the medication delivery device shown in FIG. 1 ; [0045] FIG. 35 is a cross section view of components of the medication delivery device shown in FIG. 1 ;
[0046] FIG. 36 is a cross section view of components of the medication delivery device shown in FIG. 1 ;
[0047] FIG. 37 is a schematic cross section view of components of the medication delivery device shown in FIG. 1 ;
[0048] FIG. 38 is a schematic cross section view of components of the medication delivery device shown in FIG. 1 ;
[0049] FIG. 39 is a schematic cross section view of components of the medication delivery device shown in FIG. 1 ;
[0050] FIG. 40 is a schematic cross section view of components of the medication delivery device shown in FIG. 1 ;
[0051] FIG. 41 is a schematic view of components of the medication delivery device shown in FIG. 1 ; and
[0052] FIG. 42 is a schematic view of components of the medication delivery device shown in FIG. 1 .
DETAILED DESCRIPTION
[0053] The examples of a delivery system for dispensing a biologically- active substance to a patient and related methods of use disclosed are discussed in terms of a medication delivery pen for dispensing a biologically-active substance to a patient and more particularly, in terms of injection devices including components for setting and delivering one or more selected doses from a medication cartridge. In some examples, the present delivery system and method are employed for the administration of one or more medications, for example, insulin. In some examples, the present delivery system includes a medication delivery pen having components configured to provide audible and/or tactile feedback associated with dose setting, dose correction and/or dose delivery. In some examples, the medication delivery pen has components configured to provide audible and/or tactile feedback including indicia, for example, clicks generated by at least one component having one or more teeth. In some examples, the medication delivery pen includes one or more ratchet components that generate torque for drive movement corresponding to a force directly associated with audible and/or tactile feedback. In some examples, the ratchet components include one or more arm configurations that provide uniform audible and/or tactile feedback. In some examples, one or more components of the present delivery system may be reusable or disposable.
[0054] In some examples, the present delivery system includes a medication delivery pen having a first ratchet, a second ratchet and a drive ratchet, for example, a non return ratchet. In some examples, the non return ratchet is disposed between a drive component and a nut component. In some examples, the first ratchet defines a smaller circumference relative to the second ratchet. In some examples, one or more of the ratchets have one or more arms located on a component having a first ratchet section and a second ratchet section, for example, a stepped ratchet and/or a double ratchet. In some examples, the first ratchet interacts with a drive component, for example, a threaded sleeve and the second ratchet interacts with a dose setting and/or dial component, for example, a dose sleeve. In some examples, the second ratchet provides tactile feedback while increasing a selected dose setting. In some examples, the first ratchet provides tactile feedback while decreasing a selected dose setting.
[0055] In some examples, the present delivery system includes a medication delivery pen having a non return ratchet that prevents back driving of one or more components due to back pressure from a medication cartridge and/or prevents the user from winding a piston rod, for example, a leadscrew back into a housing of the medication delivery pen to avoid moving the leadscrew and/or a bearing connected to the leadscrew away from a plunger and/or cartridge stopper. In some examples, the non return ratchet controls incremental rotational step movement of the leadscrew when the leadscrew is rotated to control rotational accuracy of the medication delivery pen. In some examples, the non return ratchet resists the torque applied from the first ratchet when a user reduces dose setting to avoid pressurizing the cartridge when the user tries to reduce a selected dose.
[0056] In some examples, the present delivery system includes a medication delivery pen having one or more ratchets, as described herein, including a ratchet profile that provides a selected torque profile. In some examples, the ratchet profile includes a selected tooth profile. In some examples, the ratchet includes a tooth profile having an initial position and/or start of the ratchet. In some examples, the ratchet includes a tooth profile that provides torque to initiate rotation of the ratchet and resistance of the ratchet to back driving. In some examples, the ratchet includes a tooth profile having a continuous curve that provides a steep torque at the start of the movement and a rate of increasing torque that decreases as movement of the ratchet increases. In some examples, the ratchet includes a tooth profile having a torque gradient that decreases linearly through movement of the ratchet. In some examples, the ratchet includes a tooth profile having a continuous radius that prevents sharp changes in torque. In some examples, the ratchet has a tooth profile including an apex having a flat or even surface, and/or a plateau. In some examples, the apex is disposed adjacent a mid portion of the tooth profile. In some examples, the tooth profile transitions from the apex along a drop into an adjacent tooth profile. In some examples, the tooth profile includes a continuous curve that matches a selected torque at an initiation of ratchet movement such that the rate of increasing torque decreases as the movement of the ratchet increases. In some examples, the tooth profile includes a gradient that decreases linearly through ratchet movement.
[0057] In some examples, the present delivery system includes a medication delivery pen having one or more ratchets including a one arm arrangement. In some examples, the one arm arrangement provides audible feedback, for example, a click without excessive force application. In some examples, the one arm arrangement includes a bearing face on an opposite side of the tooth profile to maintain ratchet position and/or orientation, for example, central. In some examples, the medication delivery pen has one or more ratchets including a two arm arrangement. In some examples, the two arm arrangement provides increased rigidity and/or stiffness to medication delivery pen operation. In some examples, the medication delivery pen has one or more ratchets including a three arm arrangement that includes an even number of positions and an odd number of arms/teeth, which are self locating.
[0058] In some examples, the present delivery system includes a medication delivery pen having a drive including a single tooth ratchet. In some examples, the drive includes a three tooth ratchet that provides uniform audible and/or tactile feedback and/or balance to medication delivery pen operation to resist and/or prevent, for example, out of sync audible and/or tactile feedback.
[0059] In some examples, the present delivery system includes a medication delivery pen having a drive including a non-return drive sleeve including a single arm or leg toothed ratchet. In some examples, the drive includes a non-return drive sleeve having a three arm or leg toothed ratchet. In some examples, the drive includes a double ratchet having a first side with a toothed single arm or leg and a second side with a toothed single arm or leg. In some examples, the arms or legs are disposed in a circumferential configuration. In some examples, the first arm or leg has a greater circumference than the second arm or leg. In some examples, the double ratchet includes a bearing face configured to react to forces applied to the double ratchet, for example, a force on an opposite face of a tooth profile. In some examples, the ratchet includes first ratchet arm teeth that resist dialing up rotation that would cause second ratchet arm teeth to click over ratchet features such that dialing down does not cause rotation of the non-return drive sleeve. In some examples, the ratchet includes large diameter ratchet teeth that prevent rotation of a double ratchet during dialing down that would cause small diameter ratchet arms to click/deflect over ratchet features as the dose sleeve is rotated to select a lower dose.
[0060] In some examples, the present delivery system includes a medication delivery pen having one or more drive components with a low torque configuration. In some examples, the present delivery system includes a medication delivery pen having a leadscrew and a non-return drive sleeve that provide a range of about 80-90% of a total torque employed to move the leadscrew. In some examples, the present delivery system includes a medication delivery pen having a nut and a nonreturn drive sleeve including a tooth form and nut profile that maintains a ratchet resistance to movement and reduces peak torque by about 90% of the total torque employed to move the leadscrew. In some examples, the nut and the non-return drive sleeve include a smooth transition between different torques.
[0061] In some examples, the present delivery system includes a medication delivery pen having dose setting components including a housing thread form and dose sleeve thread form having an axial clearance in a range of about 0.10 millimeter (mm) to 0.50 mm. In some examples, the present delivery system includes a medication delivery pen having dose setting components including a housing thread form and dose sleeve thread form having a radial clearance in a range of about 0.05 mm to 0.25 mm. In some examples, the present delivery system includes a medication delivery pen having dose setting components including a housing thread form and dose sleeve thread form having clearances of about 0.30 mm axial clearance and/or 0.15 mm radial clearance. In some examples, the dose setting components include a housing thread form and a dose sleeve thread form having an axial clearance of 0.2 mm.
[0062] In some examples, the present delivery system includes a medication delivery pen having a zero dose stop with about a +Z-7 degree overshoot tolerance on a zero dose stop position.
[0063] In some examples, the present delivery system includes a medication delivery pen having a cap providing one or more of the following features: UV blocker, pocket clip, needle protector for storage, cartridge protector that absorbs impact during drop, attachable to a cartridge holder in any orientation, cap rotation limit or stop up to a torque limit, provide visual indicia of drug container and/or cartridge content, provide visual indicia of a plunger, pen needle attachment and removal, access to needle cannula and/or cartridge septum, drive and/or housing support, axial force transfer of piston rod to cartridge plunger, torque transfer limit to cartridge plunger, point load spread from piston rod to cartridge plunger surface, aids assembly, provide visual indicia of dose selected, zero dose stop, and/or non-locking threaded engagement with housing.
[0064] In some examples, the present delivery system includes a medication delivery pen having a piston rod providing one or more of the following features: large diameter ratchet teeth that prevent rotation of double ratchet during dialing down causing the small diameter ratchet arms to click/deflect over the ratchet, and/or visual indicia of proper use. In some examples, the present delivery system includes a medication delivery pen having a housing providing one or more of the following features: visual indicia of label and dial component, non-locking threaded engagement with dial component, axial constraint of nut, threaded engagement with piston rod, and/or ratchet engagement with drive, for example, a non-return drive sleeve.
[0065] In some examples, the present delivery system includes a medication delivery pen having a drive, for example, threaded sleeve providing one or more of the following features: placement of last dose nut in a correct orientation during assembly, threaded engagement with last dose nut, axial ratchet features that allow rotation with respect to dial component, for example, dose sleeve during dialing and dose delivery, and/or small diameter ratchet teeth that resist dialing up rotation causing upper ratchet arms to click over large diameter ratchet in dose sleeve.
[0066] In some examples, the present delivery system includes a medication delivery pen having a last dose nut providing one or more of the following features: prevents dialing a dose greater than the quantity of insulin that can be delivered from the cartridge, rotationally keyed to dial component, for example, dose sleeve and axially free to move along the pen axis, and/or facilitates assembly.
[0067] In some examples, the present delivery system includes a medication delivery pen having a double ratchet providing one or more of the following features: small diameter ratchet arm teeth that resist dialing up rotation causing upper ratchet arms to click over ratchet features, large diameter ratchet teeth that prevent rotation of the double ratchet during dialing down causing small diameter ratchet arms to click/deflect over ratchet features as dial component, for example, dose sleeve is rotated to select a lower dose, allows small axial movement of drive, for example, threaded sleeve during dialing, transmits axial force from the dose button to the dose sleeve, and/or limits axial travel of the threaded sleeve.
[0068] In some examples, the present delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including the step of dialing and/or cancelling a dose. In some examples, the step of dialing and/or cancelling a dose includes rotating a dose sleeve clockwise such that the dose sleeve extends out of a housing. In some examples, the step of dialing and/or cancelling a dose includes generating dose increment clicks with a top most pawl of a double ratchet clicker that clicks over teeth in the dose sleeve. In some examples, the step of dialing and/or cancelling a dose includes preventing a leadscrew and a non- return drive sleeve from rotating, as prevented by a ratchet between the non-return drive sleeve and a threaded nut. In some examples, the step of dialing and/or cancelling a dose includes selecting a largest dose as dictated by a maximum extension of the non-return drive sleeve out of the threaded sleeve. In some examples, the step of dialing and/or cancelling a dose includes rotating the dose sleeve counter clockwise and canceling a selected dose. In some examples, the step of dialing and/or cancelling a dose includes rotating a double ratchet clicker with the dose sleeve such that the lower pawl clicks over teeth of the threaded sleeve. In some examples, the step of dialing and/or cancelling a dose includes preventing rotation of the leadscrew as the pawl at an end of the non-return drive sleeve is more rigid and/or stiffer than the pawl on the double ratchet clicker so the ratchet between the double ratchet clicker and the threaded sleeve can relatively rotate. In some examples, the step of dialing and/or cancelling a dose includes a last dose nut that advances up and down the threaded sleeve as doses are dialed and/or cancelled.
[0069] In some examples, the present delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including the step of delivering a dose. In some examples, the step of delivering a dose includes engaging teeth of the dose sleeve with teeth of the threaded sleeve to lock the sleeves together. In some examples, the step of delivering a dose includes driving the dose sleeve into the body such that the dose sleeve rotates to rotate the threaded sleeve, the non-return drive sleeve and the leadscrew. In some examples, the step of delivering a dose includes rotating the non-return drive sleeve without linear movement relative to a pen housing. In some examples, the step of delivering a dose includes advancing the leadscrew via a thread of a threaded nut by an amount equal to an angle of rotation multiplied by a pitch of a thread of the leadscrew. In some examples, the step of delivering a dose includes discontinuing applying force to a dose button prior to completion of an injection, for example, halfway through the injection such that the dose sleeve can be rotated to zero and the dose cancelled and/or continuing to apply force to the dose button to continue the injection. In some examples, the step of delivering a dose includes the last dose nut that changes position, for example, moves up the threaded sleeve during dose dialing. In some examples, when the last dose nut advances to a top of the threaded sleeve, the last dose nut abuts and/or engages in a fixed orientation with the threaded sleeve and prevents further clockwise movement of a dose selector, which limits the size of a final dose that can be dialed.
[0070] In some examples, the present delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including the step of resisting and/or preventing a pawl or ratchet arm of an end of the non-return drive sleeve to resist torque transferred from the dose sleeve to overcome a smaller pawl or ratchet arm of the double ratchet and the torque that drives the threaded sleeve over an axial toothed engagement with the dose sleeve. In some examples, the present medicament delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including an axial ratchet engagement between the threaded sleeve and the double ratchet such that during dose setting or dose correction, the axial teeth of the threaded sleeve and the double ratchet move over each other, and during dose delivery the axial teeth of the threaded sleeve and the double ratchet are axially engaged by a user resulting in the dose sleeve and the threaded sleeve rotating such that the non-return drive sleeve rotates and drives the leadscrew for delivering a dose.
[0071] In some examples, the present delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including the step of preventing rotation of the double ratchet during dose correction via large ratchet teeth that cause small diameter ratchet arms to click/deflect over the ratchet features as the dose sleeve is rotated to select a lower dose. In some examples, the medication delivery pen allows a small axial movement of the threaded sleeve during dose dialing. In some examples, the present medicament delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including the step of preventing rotation of the non-return drive sleeve backwards. In some examples, the present medicament delivery system includes a medication delivery pen employed with a method for dispensing medicament to a patient including the step of preventing dialing a dose greater than the quantity of insulin that can be delivered from the cartridge, for example, via a last dose nut. In some examples, the last dose nut is rotationally keyed to the dose sleeve and axially free to move along a device axis.
[0072] The present disclosure may be understood more readily by reference to the following detailed description of the examples taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular examples by way of example only and is not intended to be limiting. In some examples, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another example includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another example. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior.”
[0073] As used in the specification and including the appended claims, “treating” or “treatment” of a disease or condition may include administering one or more medications to a patient (human or other mammal). Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment includes, but is not limited to, reducing acute or chronic inflammation, inducing an anti-platelet effect, reducing hypertension, and lowering cholesterol.
[0074] In some examples, a medication dose includes each individual release of a substance into body tissue. In some examples, a biologically-active substance includes any substance or substances comprising a medicament, medication or drug including an active therapeutic substance, metabolite, hormone, steroid, vitamin, fatty acid, amino acid, sugar, carbohydrate, polypeptide or mineral. In some examples, a biologically-active substance includes any substance used for treatment, prevention, diagnosis, cure or mitigation of disease or illness. In some examples, a biologically- active substance includes any substance that affects anatomical structure or physiological function. In some examples, a biologically-active substance includes any substance that alters the impact of external influences on an animal, or metabolite thereof.
[0075] In some examples, a biologically-active substance includes a drugcontaining flowable medicine released into body tissue in a controlled manner, such as a liquid, solution, gel or fine suspension. In some examples, a drug includes one or more pharmaceuticals, for example, peptides, proteins such as insulin, insulin analogues and C-peptide, hormones, biologically derived or active agents, hormonal and gene based agents, and/or nutritional formulas. In some examples, a biologically- active substance, as described herein, may be employed for treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome, angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.
[0076] The following discussion includes a description of a dispensing system including a medication injection device, related components and methods of employing the dispensing system. Alternate examples are also disclosed. Reference is made in detail to the examples of the present disclosure, which are illustrated in the accompanying figures. Turning to FIGS. 1-4, there are illustrated components of a dispensing system including a medication injection pen 10.
[0077] The components of medication injection pen 10, individually or collectively, can be fabricated from materials suitable for storage and dispensing of medication. In some examples, such materials include metals, ceramics, synthetic polymers such as thermoplastics, semi-rigid and rigid materials, elastomers, fabric and/or their composites. Various components of medication injection pen 10 may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, and durability. The components of medication injection pen 10, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of medication injection pen 10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.
[0078] Medication injection pen 10 includes a housing 12 that defines a longitudinal axis A, and supports dose setting and drive components, as described herein. Housing 12 is connected to a cartridge housing 14 that supports a medication cartridge 16. Medication injection pen 10 includes a pen cap 18 to selectively cover medication cartridge 16 and cartridge housing 14. In some examples, as shown in FIGS. 5-9, cartridge housing 14 is attached with housing 12 via one or more projections 20 and/or pen cap 18 is removably attached with cartridge housing 14 via a flange 22. In some examples, cartridge housing 14 is disposed in an interference orientation with a nut 24, as described herein.
[0079] In some examples, pen cap 18 blocks ultraviolet light and provides a pocket clip. In some examples, pen cap 18 protects a pen needle during storage. In some examples, pen cap 18 protects medication cartridge 16 and can absorb impact during a drop. In some examples, pen cap 18 holds on medication cartridge 16 in any orientation, for example, an orientation to stop, up to a torque limit, pen cap 18 from rotating cartridge housing 14, an orientation to supports the weight of medication cartridge 16, an orientation to provide visual indicia of medication cartridge 16, an orientation to provide visual indicia of medication cartridge 16 content, an orientation to provide visual indicia of the plunger, and/or an orientation to provide visual indicia of medication cartridge 16 scale to inform users of approximate content remaining. In some examples, pen cap 18 allows needle attachment, removal and access to a needle canula to a cartridge septum. In some examples, pen cap 18 rotation is limited when mounted in a specific orientation.
[0080] A dose member, for example, a dose sleeve 26 has a dose set knob 28 that is rotatable to set a desired dose. Dose set knob 28 is disposed with a proximal end of dose sleeve 26. Dose sleeve 26 includes a plurality of numerals corresponding to dosage units visible through a window 31 provided on housing 12. Dose set knob 28 is rotatable to set a desired dose, which is visible through window 31 . Housing 12 includes an indicator 32 that provides tactile and/or visual indicia of a set dose. In some examples, dose set knob 28 includes a grip surface. In some examples, as shown in FIGS. 10-12, dose sleeve 26 includes a stop 34 and housing 12 includes a stop 36, which are engageable to define a zero dose stop angular position during dose setting that corresponds to the end of a dose position.
[0081] An outer surface of dose sleeve 26 threadably engages an inner surface of housing 12. Dose sleeve 26 includes a wall having an outer helical track engageable with a helical rib along a wall of housing 12. In some examples, as shown in FIG. 13, the thread form of the dose sleeve 26 and/or housing 12 includes an axial clearance of about 0.2-0.3 mm and a radial clearance of 0.15 mm.
[0082] A drive member, for example, a drive sleeve 38 has an enlarged proximal end 30 and a wall that defines longitudinal slots 47. Drive sleeve 38 fits into dose sleeve 26 and over a drive member, for example, a non return drive sleeve 42. In some examples, drive sleeve 38 has a toothed dog clutch engagement with dose sleeve 26, as described herein. Drive sleeve 38 is keyed to non return drive sleeve 42 and nut 24, as described herein, is fixed with housing 12. Sleeve 42 has a wall including splines 45 that slide within slots 47 such that sleeves 38, 42 are fixed in rotation and relatively axially translatable.
[0083] Nut 24 has an internal thread and is fixed with housing 12. Nut 24 includes an outer surface having one or more locking elements 46 that matingly engage one or more locking elements of an inner surface of housing 12 to lock nut 24 against rotation relative to housing 12, as shown in FIG . 14. A piston rod 48 has an external thread that is engageable with and rotates through the internal thread of nut 24. Piston rod 48 has a distal end connected with and providing a bearing 50 for a pressure foot, which is rotatable relative to piston rod 48, and engageable with a plunger of medication cartridge 16.
[0084] Non return drive sleeve 42 is supported with nut 24 to prevent relative axial movement of non return drive sleeve 42 and allow uni directional rotation of non return drive sleeve 42 relative to nut 24 via a non return ratchet 52, as shown in FIG. 15. Non return ratchet 52 functions between non return drive sleeve 42 and nut 24. In some examples, non return ratchet 52 prevents back driving of medication injection pen 10 due to backpressure from medication cartridge 16 as well as preventing a user from winding piston rod 48 back into housing 12 that would move piston rod 48 away from the plunger of medication cartridge 16. In some examples, non return ratchet 52 controls the incremental rotational step of piston rod 48 when piston rod 48 is rotated.
[0085] Non return ratchet 52 includes one or more ratchet arms, as described herein, which engage a ratchet profile, as described herein, of nut 24 to prevent rotation of non return drive sleeve 42 in a direction, for example, a dose setting direction and allow rotation of non return drive sleeve 42 in an opposite direction, for example, a dose dispensing direction. For example, as shown in FIGS. 15 and 17, non return drive sleeve 42 includes ratchet arms 80 having a tooth 84 and nut 24 includes inner teeth 82. Teeth 82 each include a face 83 and a back drive face 85 that increases the back drive resistance during engagement with tooth 84, for example, during dose setting to prevent rotation of drive sleeve 38 and/or non return drive sleeve 42 relative to housing 12 during dose setting. In some examples, nut 24 includes a circumferential wall 25 such that face 83 extends from wall 25 to define radius R. In some examples, face 83 defines an arc, which in some examples may have a uniform radius. In some examples, face 83 may define alternate configurations, for example, a variable radius, linear, arcuate, planar, undulating, offset, increasing or decreasing incline, tapered or helical. In some examples, teeth 82 each include an apex, for example, snap over radius 87 described herein, disposed between face 83 and face 85 adjacent a mid portion of the tooth profile of teeth 82. In some examples, the tooth profile of teeth 82 transitions from an apex along a drop into an adjacent tooth profile. In some examples, the tooth profile of teeth 82 transitions from an apex along a steep or sharp angle drop to define a greater back drive resistance force to prevent rotation of drive sleeve 38 and/or non return drive sleeve 42 relative to housing 12 during dose setting.
[0086] Tooth 84 is engageable with face 83 during dose dispensing to allow rotation of drive sleeve 38 and/or non return drive sleeve 42 relative to housing 12. Ratchet arms 80 of non return drive sleeve 42 follow inner teeth 82 such that a ratchet profile including tooth 84 engage inner teeth 82 to rotate the respective faces of tooth 84 and teeth 82 through flat surface contact and the surfaces slide across each other. Tooth 84 is engageable with back drive face 85 during dose setting to prevent rotation of drive sleeve 38 and/or non return drive sleeve 42 relative to housing 12. Engagement of tooth 84 and teeth 82, due to their respective configurations as described herein, prevents non return drive sleeve 42, and drive sleeve 38 by its keyed connection to non return drive sleeve 42, from rotating in a dose setting direction and allowing rotation of non return drive sleeve 42 in a dose dispensing direction.
[0087] In some examples, as shown in FIG. 16, housing 12 includes a bulkhead 113 including a continuous circular configuration that supports, guides and/or aligns the components of non return ratchet 52, as described herein, with housing 12. In some examples, engagement of tooth 84 and teeth 82, due to their respective configurations as described herein, defines a torque gradient that decreases linearly as the respective faces slide across each other. In some examples, as used herein, “a torque gradient that decreases linearly” is understood to mean that the rate of change of torque progressively decreases in a continuous fashion (as opposed to step-wise) and is in no way limited to a strictly linear relationship in the mathematical sense. In some examples, teeth 82 include a snap over radius 87, disposed between face 83 and face 85, which guides and/or regulates movement of tooth 84 as it slides from face 83 to face 85.
[0088] In some examples, non return ratchet 52 has one or more ratchet arms of non return drive sleeve 42, each including a ratchet profile having a tooth 184 that follow inner teeth 182 of nut 24, as shown in FIGS. 17-19. In some examples, tooth 184 has a uniform and/or continuous radius such that non return ratchet 52 provides performance characteristics including a torque profile as depicted in the graphical representation shown in FIG. 20. In some examples, non return ratchet 52 maintains resistance to movement at the initiation of rotation while reducing peak torque required. In some examples, non return ratchet 52 includes a ratchet profile having a tooth form including a tooth shape with a uniform and/or continuous radius that prevents sharp changes in torque. In some examples, dimensions of the ratchet profile of non return ratchet 52 were selectively varied, as shown in FIGS. 21 -23 to provides performance characteristics, as depicted in the graphical representations shown in FIGS. 24-26, respectively. In some examples, engagement of tooth 84 with face 83 generates a peak torque in a range of about 2.00 to 3.00 Nmm. In some examples, engagement of tooth 84 with face 85 generates a maximum back drive resistance torque in a range of about 3.00 to 6.00 Nmm.
[0089] In some examples, non return ratchet 52 has a 2-arm configuration of non return drive sleeve 42, each arm 242 including a ratchet profile having a tooth 252 that follows inner teeth 290 of nut 24, as shown in FIG. 27 and similar to that described herein. In some examples, engagement of tooth 252 with teeth 290 during dose dispensing generates a peak torque in a range of about 1.00 to 2.00 Newton millimeters (Nmm). In some examples, non return ratchet 52 has a 3-arm configuration of non return drive sleeve 42, as shown in FIG. 28 and similar to that described herein, which includes a first circumferential arm 334 having a tooth 352, a second circumferential arm 334 having a tooth 352 and a third circumferential arm 334 having a tooth 352, arms 334 being approximately equidistantly spaced about non-return drive sleeve 42. In some examples, as used herein with reference to the arms, “approximately equidistantly” refers to the arms being spaced as close to equidistantly as practicable in view of the tooth number and geometry of the nut. For example, in the non-limiting example shown in Fig. 28, the arms are considered “approximately equidistant” even though one of the spaces between teeth 352 of circumferential arms 334 is slightly smaller than the other two (in this non-limiting example, one fewer tooth 52 of nut 24 shorter) due to the total number of teeth 52 of nut 24 not being divisible by 3. Each arm 334 has a ratchet profile including a tooth 352 that follows inner teeth 390 of nut 24. Arms 334 are configured for disposal with nut 24 such that non-return drive sleeve 42 is coaxially aligned with axis A of housing 12. In some examples, arms 334 are disposed with nut 24 such that non-return drive sleeve 42 is configured for self centering and/or self locating with nut 24 for coaxial orientation with axis A. In some examples, engagement of tooth 352 with teeth 390 generates a peak torque in a range of about 2.00 to 3.00 Nmm. A comparison of the performance characteristics of the 2- arm configuration and 3-arm configuration of non return ratchet 52 including a torque profile is depicted in the graphical representation shown in FIGS. 29-31. In some examples, non return ratchet 52 includes a 3 arm configuration having an even number of positions and an odd number of arms and teeth such that teeth 352 and teeth 390 are configured to provide audible and tactile feedback including a single click per tooth.
[0090] A click member, for example, a double ratchet 84 having a ratchet, for example, a small ratchet 90 and a ratchet, for example, a large ratchet 92, as shown in FIGS. 32-36. Double ratchet 84 is attached to a dose button 54 via a snap ring or similar and is positioned on a top surface of drive sleeve 38. Small ratchet 90 includes a single arm configuration and has an arm 94. Arm 94 includes a bearing 96 and a tooth 98 that form a ratchet profile with inner teeth 100 of drive sleeve 38 such that tooth 98 follows inner teeth 100. Tooth 98 engages inner teeth 100 to rotate the respective faces of tooth 98 and teeth 100 through the flat surface contact and the two surfaces slide across each other. Engagement of tooth 98 and teeth 100, due to their respective configurations as described herein, allows relative rotation between double ratchet 84 and drive sleeve 38 in a first direction to provide tactile and/or audible indicia/feedback, for example, clicking, and prevents relative rotation between double ratchet 84 and drive sleeve 38 in a second opposite direction. Large ratchet 92 includes a single arm configuration and has an arm 102. Arm 102 includes a bearing 104 and a tooth 106 that form a ratchet profile with inner teeth 108 of dose sleeve 26 such that tooth 106 follows inner teeth 108. Tooth 106 engages inner teeth 108 to rotate the respective faces of tooth 106 and teeth 108 through the flat surface contact and the two surfaces slide across each other. Engagement of tooth 106 and teeth 108, due to their respective configurations as described herein, allows relative rotation between double ratchet 84 and dose sleeve 26 in a first direction to provide tactile and/or audible indicia/feedback, for example, clicking, and prevents relative rotation between double ratchet 84 and dose sleeve 26 in a second opposite direction.
[0091] Small ratchet 90 interacts with drive sleeve 38 and large ratchet 92 interacts with dose sleeve 26. In some examples, non return ratchet 52 resists the torque from small ratchet 90 when a user reduces a dose to avoid back pressurizing of medication cartridge 16. In some examples, tooth 98 of small ratchet 90 resists rotation as a dose is set with dose sleeve 26 such that large ratchet 92 deflects and clicks over tooth 108 of dose sleeve 26, and tooth 108 of large ratchet 92 prevents rotation of double ratchet 84 during reduction of a set dose, which causes the tooth 98 of small ratchet 90 to deflect and click over teeth 100 of drive sleeve 38 as dose sleeve 26 is rotated to select a lower dose. In some examples, a pawl of a ratchet arm of non return drive sleeve 42 can resist the torque transferred from dose sleeve 26 to overcome small ratchet 90 and the torque to lift drive sleeve 38 over the axial toothed engagement with dose sleeve 26.
[0092] Large ratchet 92 provides tactile feedback during dose setting. Small ratchet 90 provides tactile feedback during reduction of a set dose. In some examples, small ratchet 90 is more flexible and/or less rigid relative to non return ratchet 52 to avoid back pressurizing of medication cartridge 16 when a user reduces a dose. In some examples, non return ratchet 52 includes a one arm ratchet having opposing bearing faces to maintain double ratchet 84 centrally positioned relative to housing 12. In some examples, large ratchet 92 includes a bearing face and a tooth form rounded and/or arcuate to produce a continuous running face. In some examples, small ratchet 90 includes a tooth form rounded and/or arcuate to produce a continuous running face. In some examples, during dialing up or down of a selected dose with dose sleeve 26, tooth 98 of small ratchet 90 move and/or slide over teeth 100 of drive sleeve 38. In some examples, during dose delivery of a selected dose with user actuated pressure applied to dose button 54, tooth 98 of small ratchet 90 translates axially and engages teeth 100 of drive sleeve 38 such that dose sleeve 26 and drive sleeve 38 are fixed in rotation causing non return drive sleeve 42 to rotate, being rotationally fixed with drive sleeve 38, such that piston rod 48 rotates and is translated axially to deliver a set dose. In some examples, tooth 106 of large ratchet 92 engages teeth 108 of dose sleeve 26 and prevents rotation of double ratchet 84 during dialing down, which causes tooth 98 of small ratchet 90 to deflect and click over teeth 100 of drive sleeve 38 as dose sleeve 26 is rotated to select a lower dose. In some examples, drive sleeve 38 includes axial movement and/or play during dose set.
[0093] Dose sleeve 26 is threaded with housing 12 and drive sleeve 38 is supported by and fixable with dose sleeve 26. Drive sleeve 38 is in keyed engagement with non return drive sleeve 42 and non return drive sleeve 42 is engageable and rotationally fixed with piston rod 48, as described herein. Piston rod 48 extends through non return drive sleeve 42. Non return drive sleeve 42 includes an inner surface having a non circular cross section that is engageable with an outer surface of piston rod 48. The outer surface of piston rod 48 has a non circular cross section. Rotation of non return drive sleeve 42 is transmitted to piston rod 48 such that rotation of piston rod 48 relative to non return drive sleeve 42 is prevented. Piston rod 48 is threaded with the inner threads of nut 24 such that piston rod 48 translates through nut 24 in a distal direction and the relative rotational movement therebetween converts the rotation to linear movement of piston rod 48. Piston rod 48 engages plunger bearing 50 and bearing 50 transmits the axial force to the plunger. As such, axial movement of piston rod 48 relative to non return drive sleeve 42 in a distal direction is allowed as the external thread of piston rod 48 engages the internal thread of nut 24 such that piston rod 48 rotates through nut 24 to dispense a selected dose of medication.
[0094] To set a dose of medication with medication injection pen 10, as shown in FIG. 37, a user rotates dose sleeve 26 with dose set knob 38. In some examples, dose sleeve 26 can be rotated for dialing, reducing and cancelling a set dose. For example, as shown in FIG. 38, to set a selected dose of medication, dose set knob 28 is rotated to rotate dose sleeve 26 in a clockwise direction, as viewed from dose button 54 end of medication injection pen 10, which translates dose sleeve 26 in a proximal direction and out of housing 12. Dose increment clicks are provided by teeth 106 of large ratchet 92 of double ratchet 84 clicking over teeth 108 of dose sleeve 26, as described herein. Piston rod 48 and non return drive sleeve 42 do not rotate, as prevented by non return ratchet 52 and the components of non return drive sleeve 42 and nut 24, as described herein.
[0095] The largest selectable dose is dictated by the maximum extension of non return drive sleeve 42 out of and extending in a proximal direction from threaded sleeve 38, as limited by a last dose nut 110, as shown in FIGS. 39 and 40. Upon reaching a medication amount remaining in medication cartridge 16, last dose nut 110 prevents rotation of dose sleeve 26 to prevent selecting a dose greater than a maximum dose and/or medication amount remaining in medication cartridge 16. Drive sleeve 38 is threadably engaged with last dose nut 110. Last dose nut 110 is keyed to, via a spline and slot configuration, and rotatably fixed with dose sleeve 26 and rotatable relative to drive sleeve 38 as last dose nut 110 is rotatable with the threads of drive sleeve 38. In some examples, this configuration causes large ratchet 92 to deflect and click over teeth 108 of dose sleeve 26.
[0096] Last dose nut 110 is keyed to dose sleeve 26, and drive sleeve 38 has an outer surface including a thread such that last dose nut 110 follows the thread path of drive sleeve 38. Last dose nut 110 rotates relative to and translates axially along drive sleeve 38 by an amount corresponding to the rotation during dose dialing. When last dose nut 110 reaches the top of drive sleeve 38, as shown in FIGS. 40 and 41 , last dose nut 110 is fixed with drive sleeve 38 and prevents further clockwise movement of dose sleeve 26. This configuration of last dose nut 110 limits the size of a final dose that can be dialed. In some examples, a distal end of dose sleeve 26 engages nut 38 to prevent setting a dose below a selected zero amount of medication in medication cartridge 16.
[0097] To reduce or cancel a set dose, dose sleeve 26 with dose set knob 28 is rotated, for example, in a counter clockwise direction. Double ratchet 84 rotates with dose sleeve 26 and tooth 98 of small ratchet 90 of double ratchet 84 clicks over teeth 100 of drive sleeve 38. Piston rod 48 and non return drive sleeve 42 do not rotate as tooth 84 of non return drive sleeve 42 is stiffer and/or more rigid than teeth 98 of drive sleeve 38. As one or more doses are dialed, reduced or cancelled, last dose nut 110 translates in a proximal direction or a distal direction to advance up and down drive sleeve 38. [0098] To deliver a dose, as shown in FIG. 42, dose button 54 is user actuated and drives teeth 112 of drive sleeve 38 into engagement with teeth 114 of dose sleeve 26 for rotational fixation therebetween. Such engagement rotates dose sleeve 26, for example, in a counter clockwise direction and translates dose sleeve 26 in a distal direction into housing 12. As dose sleeve 26 rotates, drive sleeve 38, non return drive sleeve 42 and piston rod 48 rotate in a counter clockwise direction due to their component connection, as described herein. Non return drive sleeve 42 rotates but does not translate axially relative to housing 12. In some examples, piston rod 48 translates axially in a distal direction via the internal thread of nut 38 by an amount equal to the angle of rotation times the pitch of piston rod 48 such that bearing 50 engages with the plunger of medication cartridge 16 to dispense a set dose of medication.
[0099] In some examples, if a user stops pressing dose button 54 during an injection, the user can rotate dose sleeve 26 to a zero position and cancel the set dose, or continue injecting by pressing dose button 54. As the dose is delivered, last dose nut 110 does not change its position on drive sleeve 38.
[00100] In some examples, bearing 50 transfers an axial force of piston rod 48 to medication cartridge 16 such that the plunger limits the torque transfer and spreads a point load from piston rod 48 to the plunger surface. In some examples, dose sleeve 26 supports double ratchet 48 and displays a selected dose.
[00101] In some examples, medication injection pen 10 includes child resistance features, while being easily accessible by an adult. For example, medication injection pen 10 includes components that are movable between a child resistant, locked and/or medication non-accessible configuration and an unlocked and/or medication accessible configuration. In some examples, instructive indicia are positioned with housing 12.
[00102] It will be understood that various modifications may be made to the examples disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.