WO2017039786A1 - Syringe assembly adapter for a syringe - Google Patents
Syringe assembly adapter for a syringe Download PDFInfo
- Publication number
- WO2017039786A1 WO2017039786A1 PCT/US2016/038337 US2016038337W WO2017039786A1 WO 2017039786 A1 WO2017039786 A1 WO 2017039786A1 US 2016038337 W US2016038337 W US 2016038337W WO 2017039786 A1 WO2017039786 A1 WO 2017039786A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- barrel
- adapter
- flange
- syringe
- aperture
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
- A61M2005/3139—Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
Definitions
- the present disclosure generally relates to an adapter for a syringe, and more particularly, to an adapter that aids a user in handling and operating a syringe.
- Syringes are devices for subcutaneous delivery of a medicament to a patient.
- Syringes typically include a barrel containing a medicament and a plunger movable through the barrel to discharge the medicament.
- a medically trained professional operates the syringe to administer the medicament to a patient.
- Handling a syringe can be challenging for inexperienced patients as well as elderly and infirm patients whose gripping strength and/or dexterity may be compromised.
- patients may have difficulty gripping the syringe barrel while simultaneously pushing down on the plunger to administer the medicament. Additionally, patients may inadvertently withdraw the plunger from barrel, thereby compromising the sterility of the medicament and potentially causing it to leak from the barrel.
- conventional adapters usually include a c-shaped gripping member having an aperture for receiving a barrel of the syringe.
- the aperture usually has an inner diameter that is less than or equal to an outer diameter of the barrel so that the gripping member securely grasps the barrel. Due to this difference in diameters, however, the gripping member may strongly resist insertion of the barrel into the aperture.
- the present disclosure sets forth a syringe adapter that embodies advantageous alternatives to existing syringe adapters, and that may address one or more of the challenges or needs mentioned above, as well as provides other benefits and advantages.
- an adapter for a syringe including a gripping member and a finger flange attached to the gripping member.
- the gripping member may have a proximal end and a distal end.
- a first aperture may extend between the proximal and distal ends along a longitudinal axis of the adapter.
- the first aperture may be configured to at least partially surround and engage at least a portion of a barrel of the syringe.
- the finger flange may be spaced apart from the proximal end of the gripping member along the longitudinal axis such that a cavity is defined between the finger flange and the proximal end of the gripping member.
- the cavity may be configured to receive a barrel flange extending outwardly from the barrel of the syringe.
- the proximal end of the gripping member may have a mounting surface for engaging the barrel flange when the barrel flange is positioned in the cavity. Additionally, the proximal end of the gripping member may have an inclined lead-in surface extending downwardly from the mounting surface. The inclined lead-in surface may be configured to guide the barrel flange into the cavity during assembly.
- the syringe may include a barrel configured to contain a medicament, a stopper, a plunger attached to the stopper and at least partially disposed outside the barrel, and a barrel flange protruding radially outwardly from the barrel.
- the stopper may slidably engage an inner wall of the barrel and form a fluid-tight seal with the inner wall of the barrel.
- the plunger arm may be configured to move the stopper in a distal direction to discharge medicament from the barrel and a proximal direction to draw medicament into the barrel.
- the adapter may include a gripping member and a finger flange attached to the gripping member.
- the gripping member may have a proximal end, a distal end, and a first aperture extending between the proximal and distal ends.
- the first aperture may be configured to at least partially surround and engage at least a portion of the barrel.
- the finger flange may be spaced apart from a proximal end of the gripping member such that a cavity for receiving the barrel flange is defined between the finger flange and the proximal end of the gripping member.
- the proximal end of the gripping member may have a mounting surface for engaging the barrel flange when the barrel flange is positioned in the cavity. Additionally, the proximal end of the gripping member may have an inclined lead-in surface extending
- the inclined lead-in surface may be configured to guide the barrel flange into the cavity during assembly.
- an adapter for a syringe including a gripping member, a finger flange attached to the gripping member, and a snap fit locking mechanism at least partially disposed on the finger flange.
- the gripping member may have a proximal end and a distal end.
- a first aperture may extend between the proximal and distal ends along a longitudinal axis of the adapter. The first aperture may be configured to at least partially surround and engage at least a portion of a barrel of the syringe.
- the finger flange may be attached to the gripping member and spaced apart from the proximal end of the gripping member along the longitudinal axis such that a cavity is defined between the finger flange and the proximal end of the gripping member.
- the cavity may be configured to receive a barrel flange extending outwardly from the barrel of the syringe.
- the snap fit locking may be configured to engage the barrel flange. Additionally, the snap fit locking mechanism may allow the barrel flange to be inserted into the cavity in a first direction toward the longitudinal axis and resist removal of the barrel flange from the cavity in a second direction opposite the first direction.
- FIG. 1 is top front perspective view of one embodiment of a syringe assembly constructed in accordance with principles of the present disclosure
- FIG. 2 is top front perspective view of one embodiment of a syringe constructed in accordance with principles of the present disclosure
- FIG. 3 is bottom front perspective view of one embodiment of an adapter constructed in accordance with principles of the present disclosure
- the present disclosure generally concerns an adapter for improving the usability of a syringe. More particularly, an adapter is provided that can be attached to the syringe with relative ease and which reduces the likelihood of the syringe being inadvertently detached.
- the adapter may have one or more inclined lead-in surfaces which guide the syringe into the adapter and thereby reduce the force necessary to connect the adapter to the syringe.
- the adapter may include one or more locking tabs which securely retain the syringe once the syringe has been inserted into the adapter.
- the inclined lead-in surfaces and/or locking tabs may provide a snap fit locking mechanism which is intuitive to use and relatively easy to manufacture.
- the syringe assembly 10 includes a syringe 12 and an adapter 14 attached to an exterior of the syringe 12.
- the adapter 14 may initially be an accessory or separate component from the syringe 12.
- An end user e.g., a patient, a doctor, a nurse, a pharmacist, etc.
- the adapter 14 may improve the ergonomics and/or usability of the syringe 12 as compared to use of the syringe 12 without the adapter 14.
- the syringe 12 may include a barrel 20 (depicted here as being transparent) having an open proximal end 22 and an opposing distal end 24.
- the barrel 20 may have an inner wall 26 surrounding an internal bore 28, and an outer wall 30.
- the barrel 20 have a generally circular cross-sectional shape have an outer diameter Dl.
- the internal bore 28 may be contain a medicament (not illustrated) provided in a liquid or gelatin form, for example.
- a cannula 32 e.g., a needle
- the cannula 32 may extend from the distal end 24 of the barrel 20 and possess an internal bore (not illustrated) that is in fluid communication with the internal bore 28 of the barrel 20. Additionally, the cannula 32 may have pointed distal end 33 for piercing the epidermis and/or other soft tissue of the patient.
- the syringe 12 may further include a plunger 34 comprised of a plunger arm 36, a stopper 38 removably attached to a distal end of the plunger arm 36, and a thumb rest 40 fixed to a proximal end of the plunger arm 36.
- the plunger arm 36 may extend through the open proximal end 22 of the barrel 20 so that the stopper 38 and the thumb rest 40 are positioned, respectively, inside and outside the barrel 20.
- the stopper 38 may slidably engage, and form a fluid-tight seal with, the inner wall 26 of the barrel 20.
- a user may push down on the thumb rest 40 to move the stopper 38 in a distal direction through the internal bore 28.
- medicament may be forced out of the distal end 24 of the barrel 20, through the internal bore of the cannula 32, and subsequently into the patient, if the pointed end 33 of the cannula 32 has been inserted subcutaneously.
- a user may pull up on the thumb rest 40, thereby moving the stopper 38 in a proximal direction through the internal bore 28. This action may create a vacuum capable of suctioning material through the internal bore of the cannula 32 and into the barrel 20.
- a barrel flange 42 (depicted here as being transparent) may be disposed about and protrude radially outwardly from the proximal end 22 of the barrel 20. As described below in more detail, the barrel flange 42 may be received in a cavity of the adapter 14 when the adapter 14 is attached to the syringe 12.
- the barrel flange 42 may include a proximal end surface 44, a distal end surface 46, and an outer peripheral 48 surface extending between the proximal end surface 44 and the distal end surface 46.
- the outer peripheral surface 48 may define the outer circumference of the barrel flange 42.
- the barrel flange 42 may have a thickness T defined by the distance between the proximal end surface 44 and the distal end surface 46.
- the adapter 14 will now be described in greater detail with reference to Figs. 3-9.
- the adapter 14 includes a finger flange 50 and a gripping member 52.
- the finger flange 50 may have a proximal end 54 and a distal end 56
- the gripping member 52 may have a proximal end 58 and a distal end 59.
- the distal end 59 of the gripping member 52 may be connected to the distal end 56 of the finger flange 50.
- distal end 59 of the gripping member 52 and the distal end 56 of the finger flange 50 may be integrally formed as a single unitary body, whereas in other embodiments, they may be separate members joined together with an additional intermediate member (not illustrated).
- the proximal end 58 of the gripping member 52 may be spaced apart from the proximal end 54 of the finger flange 50 along a longitudinal axis A of the adapter 14 such that a cavity 60 is defined between the proximal end 58 of the gripping member 52 and the proximal end 54 of the finger flange 50.
- the cavity 60 may receive the barrel flange 42 of the syringe 12 during assembly.
- the cavity 60 may have a height H defined by the distance separating the proximal end 58 of the gripping member 52 and the proximal end 54 of the finger flange 50.
- the height H may vary depending on the location where the height H is measured between the proximal end 58 of the gripping member 52 and the proximal end 54 of the finger flange 50. Nevertheless, the height H at any location may be greater than or equal to the thickness T of the barrel flange 42.
- the distal end surface 46 of the barrel flange 42 may engage an upwardly facing mounting surface 61 of the proximal end 58 of the gripping member 52.
- the mounting surface 61 may be substantially planar and coincident with an imaginary horizontal plane P (see Fig. 9) that is orthogonal to the longitudinal axis A.
- the mounting surface 61 and a distal end surface 63 of the proximal end 54 of the finger flange 50 may face each other.
- the distal end 56 of the finger flange 50 may include first and second finger plates 62 and 64 positioned on opposite sides of the gripping member 52 and which each extend outwardly away from the longitudinal axis A.
- the first and second finger plates 62 and 64 may possess, respectively, a first concave distal end surface 66 and a second concave distal end surface 68 which may help the user grip the finger flange 50 with his or her fingers when pushing down on the plunger 34 with his or her thumb to discharge the medicament from the barrel 20.
- a first aperture 70 may extend through a central portion of the gripping member 52 along the longitudinal axis A between the proximal and distal ends 58 and 60 of the gripping member 52.
- the first aperture 70 may have a generally circular cross- sectional shape and may be configured to at least partially surround and engage at least a portion of the barrel 20 when the adapter 14 is attached to the syringe 12 (see Fig. 1).
- the first aperture 70 may have a width Wl, which in some embodiments may correspond to an inner diameter of the first aperture 70, that is equal to or less than an outer diameter Dl of the barrel 20 so that a tight fit is formed between the gripping member 52 and the outer wall 30 of the barrel 20 when the barrel 20 is received in the first aperture 70. Accordingly, the gripping member 52 may squeeze and frictionally inhibit removal of the barrel 20 from the adapter 20 in a direction orthogonal to and away from the longitudinal axis A.
- a second aperture 72 may extend through the proximal end 54 of the finger flange 50 along the longitudinal axis A, and may be at least partially aligned with the first aperture 70.
- the second aperture 72 may have a generally U-shaped cross- sectional shape which opens at its side through a front end 74 of the finger flange 50.
- a width W2 of the second aperture 72 which in some embodiments may correspond to an inner diameter of the second aperture 72, may be greater than that of the plunger arm 36, thereby allowing the plunger arm 36 to reciprocate freely in the proximal and distal directions through the second aperture 72.
- the width W2 of the second aperture 72 may be less than a maximum width of the plunger 34, which in the present embodiment corresponds to an outer diameter D2 of the stopper 38. Accordingly, the stopper 38 may abut the proximal end 54 of the finger flange 50 if the plunger 34 is withdrawn past a certain point in the proximal direction. Therefore, the proximal end 54 of the finger flange 50 may function as a backstop that prevents, or at least inhibits, a user from inadvertently withdrawing the entire plunger 34 from the barrel 20. Thus, it is less likely that the sterility of the medicament will be comprised and/or that the medicament will leak from the open proximal end 22 of the barrel 20 as a result of the user accidentally removing the entire plunger 34 from the barrel 20.
- Fig. 5 illustrates that, in addition to the first aperture 70, the gripping member 52 may include a third aperture 76 and a fourth aperture 78. Each of these apertures may extend through the gripping member 52 between the proximal and distal ends 58 and 60 of the gripping member 52.
- the third and fourth apertures 76 and 78 may be positioned on opposite sides of the first aperture 70 such that the third aperture 76 is positioned between the first aperture 70 and a rear end 82 of the gripping member 52, and the fourth aperture 78 is positioned between the first aperture 70 and a front end 84 of the gripping member 52.
- the third aperture 76 may have a generally U-shaped cross-sectional shape which opens at its side into the first aperture 70, as shown in Fig. 5.
- a width W3 of the third aperture 76 may be less than the width Wl of the first aperture 70.
- the third aperture 76 may enable the gripping member 52 to expand radially outwardly, away from the longitudinal axis A, to accommodate the barrel 20 is the first aperture 70.
- the gripping member 52, as well as the remainder of the adapter 14 may be made of a flexible and elastically deformable material such as an injection-molded polymer (e.g., polyethylene, polypropylene, polyurethane, etc.).
- the gripping member 52 may slightly deform when the adapter 14 is attached to the syringe 12 and regain its original shape if the syringe 12 is detached from the adapter 14.
- Fig. 5 shows that the fourth aperture 78 may open, at opposite ends, into the first aperture 70 and the front end 84 of the gripping member 52.
- the fourth aperture 78 may have a width W4 which tapers (i.e., becomes increasingly smaller) as one moves from the front end 84 of the gripping member 52 toward the first aperture 70.
- the fourth aperture 78 may provide a corridor for guiding the barrel 20 into the first aperture 70 when the barrel 20 is inserted in a direction toward the longitudinal axis A through the front end 84 of the gripping member 52.
- the adapter 14 may be provided with a snap fit locking mechanism 90 for retaining the barrel flange 42 in the cavity 60 when the adapter 14 is attached to the syringe 12. Accordingly, the snap fit locking mechanism 90 may assist the gripping member 52 in keeping the adapter 14 attached to the syringe 12. In embodiments where the gripping member 52 does not necessarily squeeze the barrel 20, the snap fit locking mechanism 90 may be the sole or primary means for securing the adapter 14 to the syringe 12.
- the snap fit locking mechanism 90 may allow the barrel flange 42 to be inserted into the cavity 60 in a first direction toward the longitudinal axis A, and may resist removal of the barrel flange 42 from the cavity 60 in a second direction away from the longitudinal axis A which is opposite to the first direction.
- the snap fit locking mechanism 90 may be configured so that the force needed to insert the barrel flange 42 into the cavity 60 in the first direction may be significantly less than the force needed to remove the barrel flange 42 from the cavity 60 in the second direction.
- the snap fit locking mechanism 90 may include a first locking tab 92 and a second locking tab 94 each disposed on the proximal end 54 of the finger flange 50.
- the first and second locking tabs 92 and 94 may each extend from the distal end surface 63 of the proximal end 54 of the finger flange 50 in a generally downward vertical direction toward the gripping member 52.
- the snap fit locking mechanism 90 may additionally include a first inclined lead-in surface 98 and a second inclined lead-in surface 100 disposed on the proximal end 58 of the gripping member 52. In alternative embodiments, the inclined lead-in surfaces 98 and 100 may be omitted.
- the first and second inclined lead-in surfaces 98 and 100 may each extend downwardly from the mounting surface 61 at an angle a relative to the horizontal plane P and terminate at the front end 84 of the gripping member 52.
- the horizontal plane P may be orthogonal to the longitudinal axis A.
- the angle a may be any angle less than 90 degrees, and in some embodiments, may be in a range between approximately (e.g., +10%) 0 - 60 degrees, or 5 - 45 degrees, or 5 - 35 degrees, or 5 - 30 degrees, or 5 - 25 degrees, or 10 - 25 degrees, or 10 - 20 degrees.
- first and second inclined lead-in surfaces 98 and 100 of the present embodiment are substantially planar, in other embodiments, they may be curved and/or possess a convex shape. Also, as illustrated in Fig. 7, the first and second inclined lead-in surfaces 98 and 100 may be positioned on opposite sides of the longitudinal axis A.
- the first and second inclined lead-in surfaces 98 and 100 each may function as a ramp that guides the barrel flange 42 up and into the cavity 60 during assembly of the adapter 14 and the syringe 12. More particularly, when a user pushes the barrel flange 42 in a horizontal direction that is orthogonal to the longitudinal axis A and toward the rear end 82 of the gripping member 52, the leading edge of the barrel flange 42 may contact the first and/or second inclined lead-in surfaces 98 and 100, which in turn may cause the barrel flange 42 to begin moving upwards in a vertical direction in addition to also moving in the horizontal direction.
- first and second inclined lead-in surfaces 98 and 100 may direct the barrel flange 42 up and into the cavity 60.
- the first locking tab 92 may include an outwardly facing surface 110, a downwardly facing surface 112, and an inwardly facing surface 114.
- the outwardly facing surface 110 may extend downwardly from the distal end surface 63 of the proximal end 54 of the finger flange 50 at an angle ⁇ relative to the horizontal plane P and terminate at the downwardly facing surface 112.
- the angle ⁇ may be any angle less than 90 degrees, and in some embodiments, may be in a range between approximately (e.g., +10%) 0 - 60 degrees, or 5 - 45 degrees, or 5 - 35 degrees, or 5 - 30 degrees, or 5 - 25 degrees, or 10 - 25 degrees, or 10 - 20 degrees.
- the outwardly facing surface 110 may be planar as illustrated in the figures, or it may possess a curvature and/or be convex.
- the outwardly facing surface 110 may function as a ramp the guides the barrel flange 42 downwards and into contact with the first and/or second inclined lead-in surfaces 98 and 100.
- the inwardly facing surface 114 which may be positioned on an opposite side of the locking tab 92 as the outwardly facing surface 110, may define a portion of a perimeter of the cavity 60 and may be configured to engage the outer peripheral surface 48 of the barrel flange 42 when the entire barrel flange 42 is positioned in the cavity 60.
- the inwardly facing surface 114 may have a contour that is substantially the same as a contour of the outer peripheral surface 48 of the barrel flange 42 so that the inwardly facing surface 114 is configured to flushly engage the outer peripheral surface 48 of the barrel flange 42.
- the inwardly facing surface 114 may possess a radius of curvature of that is substantially the same as that of the outer peripheral surface 48 of the barrel flange 42.
- a depth X (Fig 9) of the cavity 60 may be slightly less than a width W (Fig. 2) of the barrel flange 42 so that the inwardly facing surface 114 of the first locking tab 92 is configured to firmly press the barrel flange 42 against the rear interior wall 130 of the finger flange 50.
- the barrel flange 42 may be squeezed between the inwardly facing surface 114 of the first locking tab 92 and the rear interior wall 130 of the finger flange 50. This may help retain the barrel flange 42 in the cavity 60.
- the barrel flange 42 and/or the first locking tab 92 may elastically deform so that the barrel flange 42 can be accommodated in the cavity 60.
- a minimum clearance C (Fig. 9) between the downwardly facing surface 112 of the first locking tab 92 and the first inclined lead-in surface 98 may be less than or equal to the thickness T of the barrel flange 42. Accordingly, as the barrel flange 42 moves up the first inclined lead-in surface 98 during assembly, at least a portion of the downwardly facing surface 112 may contact the barrel flange 42 and squeeze it against the first inclined lead-in surface 98.
- the first locking tab 92, the barrel flange 42, and/or the gripping member 52 may elastically deform, thereby allowing the barrel flange 42 slip past the first locking tab 92 and continue moving up the first inclined lead-in surface 98 and into the cavity 60. If it is the first locking tab 92 or the gripping member 52 that elastically deforms during this process, the minimum clearance C may temporarily increase to allow the barrel flange 42 to pass between the downwardly facing surface 112 and the first inclined lead-in surface 98.
- the first locking tab 92, the barrel flange 42, and/or the gripping member 52 may expand and/or regain its original shape (i.e., snap back its original shape) and thereby inhibit the barrel flange 42 from moving back down the first inclined lead-in surface 98.
- removing the barrel flange 42 from the cavity 60 may require more force than inserting the barrel flange 42 into the cavity 60.
- the second locking tab 94 may possess an outwardly facing surface 120, a
- the present disclosure advantageously provides an adapter that securely engages a barrel flange of a syringe by utilizing a snap fit locking mechanism.
- the snap fit locking mechanism may supplement the means for gripping the outer wall of the barrel to retain the syringe. Accordingly, the snap fit locking mechanism may reduce the likelihood of the syringe being inadvertently detached from the adapter.
- the snap fit locking mechanism may be used as the sole or primary means for retaining the syringe in the adapter, which may provide more freedom in the design and manufacture of other components of the adapter such as its gripping member.
- the adapter may incorporate one or more inclined lead-in surface which may assist with inserting the barrel flange into the adapter.
- the syringe can further comprise use of a medicament listed below with the caveat that the following list should neither be considered to be all inclusive nor limiting.
- the medicament will be contained in a reservoir (e.g., the barrel of the syringe).
- the reservoir is a primary container that is either filled or pre-filled for treatment with the medicament.
- the syringe or more specifically the reservoir of the syringe may be filled with colony stimulating factors, such as granulocyte colony- stimulating factor (G-CSF).
- G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta®
- the syringe may be used with various pharmaceutical products, such as an erythropoiesis stimulating agent (ESA), which may be in a liquid or a lyophilized form.
- ESA erythropoiesis stimulating agent
- An ESA is any molecule that stimulates erythropoiesis, such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa
- An ESA can be an erythropoiesis stimulating protein.
- erythropoiesis stimulating protein means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor.
- Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor.
- Erythropoiesis stimulating proteins include, but are not limited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta, and analogs thereof, pegylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1 /hematide), and mimetic antibodies.
- Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind and activate erythropoietin receptor (and include compounds reported in U.S. Publication Nos. 2003/0215444 and 2006/0040858, the disclosures of each of which is incorporated herein by reference in its entirety) as well as erythropoietin molecules or variants or analogs thereof as disclosed in the following patents or patent applications, which are each herein incorporated by reference in its entirety: U.S. Patent Nos.
- Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies such as Vectibix® (panitumumab), XgevaTM (denosumab) and ProliaTM (denosamab); other biological agents such as Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim , G-CSF, hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such as Sensipar® (cinacalcet).
- antibodies such as Vectibix® (panitumumab), XgevaTM (denosumab) and ProliaTM (denosamab); other biological agents such as Enbrel® (e
- the device may also be used with a therapeutic antibody, a polypeptide, a protein or other chemical, such as an iron, for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose.
- a therapeutic antibody for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose.
- the pharmaceutical product may be in liquid form, or reconstituted from lyophilized form.
- proteins include the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof:
- OPGL specific antibodies, peptibodies, and related proteins, and the like also referred to as RANKL specific antibodies, peptibodies and the like
- fully humanized and human OPGL specific antibodies particularly fully humanized monoclonal antibodies, including but not limited to the antibodies described in PCT Publication No.
- WO 03/002713 which is incorporated herein in its entirety as to OPGL specific antibodies and antibody related proteins, particularly those having the sequences set forth therein, particularly, but not limited to, those denoted therein: 9H7; 18B2; 2D8; 2E11; 16E1; and 22B3, including the OPGL specific antibodies having either the light chain of SEQ ID NO:2 as set forth therein in Figure 2 and/or the heavy chain of SEQ ID NO:4, as set forth therein in Figure 4, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
- peptibodies of the mTN8-19 family including those of SEQ ID NOS:305-351, including TN8-19-1 through TN8-19-40, TN8-19 conl and TN8-19 con2; peptibodies of the mL2 family of SEQ ID NOS:357-383; the mL15 family of SEQ ID NOS:384-409; the mL17 family of SEQ ID NOS:410-438; the mL20 family of SEQ ID NOS:439-446; the mL21 family of SEQ ID NOS:447-452; the mL24 family of SEQ ID NOS:453-454; and those of SEQ ID
- IL-4 receptor specific antibodies include those described in PCT Publication No. WO 2005/047331 or PCT Application No. PCT/US2004/37242 and in U.S. Publication No.
- Interleukin 1-receptor 1 (“IL1-R1") specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in U.S. Publication No.
- Ang2 specific antibodies, peptibodies, and related proteins, and the like including but not limited to those described in PCT Publication No. WO 03/057134 and U.S. Publication No. 2003/0229023, each of which is incorporated herein by reference in its entirety particularly in parts pertinent to Ang2 specific antibodies and peptibodies and the like, especially those of sequences described therein and including but not limited to: L1(N); L1(N) WT; L1(N) IK WT; 2xLl(N); 2xLl(N) WT; Con4 (N), Con4 (N) IK WT, 2xCon4 (N) IK; L1C; L1C IK; 2xLlC; Con4C; Con4C IK; 2xCon4C IK; Con4-Ll (N); Con4-LlC; TN-12-9 (N); C17 (N); TN8-8(N); TN8-14 (N); Con 1 (N),
- WO 2003/030833 which is incorporated herein by reference in its entirety as to the same, particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558; Ab559; Ab565;
- NGF specific antibodies, peptibodies, and related proteins, and the like including, in particular, but not limited to those described in U.S. Publication No. 2005/0074821 and U.S. Patent No. 6,919,426, which are incorporated herein by reference in their entirety particularly as to NGF-specific antibodies and related proteins in this regard, including in particular, but not limited to, the NGF-specific antibodies therein designated 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
- CD22 specific antibodies, peptibodies, and related proteins, and the like such as those described in U.S. Patent No. 5,789,554, which is incorporated herein by reference in its entirety as to CD22 specific antibodies and related proteins, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, for instance, a dimer of a human-mouse monoclonal hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa- chain, including, but limited to, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0;
- IGF-1 receptor specific antibodies such as those described in PCT Publication No. WO 06/069202, which is incorporated herein by reference in its entirety as to IGF-1 receptor specific antibodies and related proteins, including but not limited to the IGF-1 specific antibodies therein designated L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36, L
- anti-IGF-lR antibodies for use in the methods and compositions of the present invention are each and all of those described in:
- 2004/0202655 (published October 14, 2004), including but not limited to antibodies PINT-6A1, PINT-7A2, PINT-7A4, PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3, PINT-11A4, PINT-11A5, PINT-11A7, PINT- 11A12, PINT-12A1, PINT-12A2, PINT-12A3, PINT-12A4, and PINT-12A5, as described therein; each and all of which are herein incorporated by reference in their entireties, particularly as to the aforementioned antibodies, peptibodies, and related proteins and the like that target IGF-1 receptors;
- B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1,” also is referred to in the literature as B7H2, ICOSL, B7h, and CD275), particularly B7RP-specific fully human monoclonal IgG2 antibodies, particularly fully human IgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, especially those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells in particular, especially, in all of the foregoing regards, those disclosed in U.S. Publication No. 2008/0166352 and PCT Publication No.
- WO 07/011941 which are incorporated herein by reference in their entireties as to such antibodies and related proteins, including but not limited to antibodies designated therein as follow: 16H (having light chain variable and heavy chain variable sequences SEQ ID NO: l and SEQ ID NO:7 respectively therein); 5D (having light chain variable and heavy chain variable sequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H (having light chain variable and heavy chain variable sequences SEQ ID NO:3 and SEQ ID NO: 10 respectively therein); 43H (having light chain variable and heavy chain variable sequences SEQ ID NO:6 and SEQ ID NO: 14 respectively therein); 41H (having light chain variable and heavy chain variable sequences SEQ ID NO:5 and SEQ ID NO: 13 respectively therein); and 15H (having light chain variable and heavy chain variable sequences SEQ ID NO:4 and SEQ ID NO: 12 respectively therein), each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
- IL-15 specific antibodies, peptibodies, and related proteins, and the like such as, in particular, humanized monoclonal antibodies, particularly antibodies such as those disclosed in U.S. Publication Nos. 2003/0138421; 2003/023586; and 2004/0071702; and U.S. Patent No. 7,153,507, each of which is incorporated herein by reference in its entirety as to IL-15 specific antibodies and related proteins, including peptibodies, including particularly, for instance, but not limited to, HuMax IL-15 antibodies and related proteins, such as, for instance, 146B7;
- IFN gamma specific antibodies peptibodies, and related proteins and the like, especially human IFN gamma specific antibodies, particularly fully human anti-IFN gamma antibodies, such as, for instance, those described in U.S. Publication No. 2005/0004353, which is incorporated herein by reference in its entirety as to IFN gamma specific antibodies, particularly, for example, the antibodies therein designated 1118; 1118*; 1119; 1121; and 1121*.
- Specific antibodies include those having the heavy chain of SEQ ID NO: 17 and the light chain of SEQ ID NO: 18; those having the heavy chain variable region of SEQ ID NO:6 and the light chain variable region of SEQ ID NO:8; those having the heavy chain of SEQ ID NO: 19 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO: 10 and the light chain variable region of SEQ ID NO: 12; those having the heavy chain of SEQ ID NO:32 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO:30 and the light chain variable region of SEQ ID NO: 12; those having the heavy chain sequence of SEQ ID NO:21 and the light chain sequence of SEQ ID NO:22; those having the heavy chain variable region of SEQ ID NO: 14 and the light chain variable region of SEQ ID NO: 16; those having the heavy chain of SEQ ID NO:21 and the light chain of SEQ ID NO:33; and those having the heavy chain variable region of SEQ ID NO: 14 and the
- TALL-1 specific antibodies include peptibodies, and the related proteins, and the like, and other TALL specific binding proteins, such as those described in U.S. Publication Nos.
- PTH Parathyroid hormone
- TPO-R Thrombopoietin receptor
- Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, and related proteins, and the like, including those that target the HGF/SF:cMet axis (HGF/SF:c-Met), such as the fully human monoclonal antibodies that neutralize hepatocyte growth factor/scatter
- HGF/SF HGF/SF
- WO 2005/017107 huL2G7 described in U.S. Patent No. 7,220,410 and OA-5d5 described in U.S. Patent Nos. 5,686,292 and 6,468,529 and in PCT Publication No. WO 96/38557, each of which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind HGF;
- TRAIL-R2 specific antibodies, peptibodies, related proteins and the like such as those described in U.S. Patent No. 7,521,048, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TRAIL-R2;
- TGF-beta specific antibodies, peptibodies, related proteins, and the like including but not limited to those described in U.S. Patent No. 6,803,453 and U.S. Publication No.
- Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like including but not limited to those described in PCT Publication No. WO 2006/081171, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind amyloid-beta proteins.
- One antibody contemplated is an antibody having a heavy chain variable region comprising SEQ ID NO:8 and a light chain variable region having SEQ ID NO:6 as disclosed in the foregoing publication;
- c-Kit specific antibodies including but not limited to those described in U.S. Publication No. 2007/0253951, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind c-Kit and/or other stem cell factor receptors;
- OX40L specific antibodies, peptibodies, related proteins, and the like including but not limited to those described in U.S. Publication No. 2006/0002929, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind OX40L and/or other ligands of the OX40 receptor; and
- Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HERl / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb); Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (
- LymphoCide® epratuzumab, anti-CD22 mAb
- BenlystaTM lymphostat B, belimumab, anti- BlyS mAb
- Metalyse® tenecteplase, t-PA analog
- Mircera® methoxy polyethylene glycol- epoetin beta
- Mylotarg® gemtuzumab ozogamicin
- Raptiva® efalizumab
- certolizumab pegol, CDP 870 SolirisTM (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM- 1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DMl);
- NeoRecormon® epoetin beta
- Neumega® oprelvekin, human interleukin-11
- Neulasta® pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF
- Neupogen® filgrastim , G- CSF, hu-MetG-CSF
- Orthoclone OKT3® muromonab-CD3, anti-CD3 monoclonal antibody
- Procrit® epoetin alfa
- Remicade® infliximab, anti-TNFa monoclonal antibody
- Reopro® abciximab, anti-GP lib/Ilia receptor monoclonal antibody
- Actemra® anti-IL6 Receptor mAb
- Avastin® bevacizumab
- HuMax-CD4 zanolimumab
- Rituxan® rituximab,
- Patent No. 7,153,507 Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthraxTM; Vectibix® (panitumumab); Xolair®
- IL-1 trap the Fc portion of human IgGl and the extracellular domains of both IL- 1 receptor components (the Type I receptor and receptor accessory protein)
- VEGF trap Ig domains of VEGFR1 fused to IgGl Fc
- diaclizumab Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody
- sclerostin antibody such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis).
- therapeutics such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA.
- a monoclonal antibody that binds human Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), e.g. U.S. Patent No. 8,030,547, U.S. Publication No. 2013/0064825, WO2008/057457, WO2008/057458, WO2008/057459,
- WO2008/063382 WO2008/133647, WO2009/ 100297, WO2009/100318, WO2011/037791, WO2011/053759, WO2011/053783, WO2008/125623, WO2011/072263, WO2009/055783, WO2012/0544438, WO2010/029513, WO2011/111007, WO2010/077854, WO2012/088313, WO2012/101251, WO2012/101252, WO2012/101253, WO2012/109530, and WO2001/031007.
- talimogene laherparepvec or another oncolytic HSV for the treatment of melanoma or other cancers.
- oncolytic HSV include, but are not limited to talimogene laherparepvec (U.S. Patent Nos. 7,223,593 and 7,537,924); OncoVEXGALV/CD (U.S. Pat. No. 7,981,669); OrienXOlO (Lei et al. (2013), World J. Gastroenterol., 19:5138-5143); G207, 1716; NV1020; NV12023; NV1034 and NV1042 (Vargehes et al. (2002), Cancer Gene Ther., 9(12):967-978).
- TIMPs are endogenous tissue inhibitors of
- TIMP-3 is expressed by various cells or and is present in the extracellular matrix; it inhibits all the major cartilage- degrading metalloproteases, and may play a role in role in many degradative diseases of connective tissue, including rheumatoid arthritis and osteoarthritis, as well as in cancer and cardiovascular conditions.
- the amino acid sequence of TIMP-3, and the nucleic acid sequence of a DNA that encodes TIMP-3, are disclosed in U.S. Patent No. 6,562,596, issued May 13, 2003, the disclosure of which is incorporated by reference herein. Description of TIMP mutations can be found in U.S. Publication No. 2014/0274874 and PCT Publication No. WO 2014/152012.
- CGRP human calcitonin gene-related peptide
- a bispecific T cell engager antibody e.g. Blinotumomab
- Blinotumomab can be used in the device.
- included can be an APJ large molecule agonist e.g., apelin or analogues thereof in the device. Information relating to such molecules can be found in PCT Publication No. WO 2014/099984.
- the medicament comprises a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody.
- TSLP anti-thymic stromal lymphopoietin
- anti- TSLP antibodies include, but are not limited to, those described in U.S. Patent Nos. 7,982,016, and 8,232,372, and U.S. Publication No.
- anti-TSLP receptor antibodies include, but are not limited to, those described in U.S. Patent No. 8,101,182.
- the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated as A5 within U.S. Patent No. 7,982,016.
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- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
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Abstract
An adapter for improving the usability of a syringe is disclosed. The adapter may include a gripping member and a finger flange. The gripping member may be configured to at least partially surround and engage at least a portion of a barrel of the syringe. The finger flange may be spaced apart from the gripping member such that a cavity is defined between the finger flange and the gripping member for receiving a barrel flange that extends outwardly from the barrel of the syringe. The adapter may additionally include a snap fit locking mechanism which allows the barrel flange to be inserted into the cavity in a first direction and resists removal of the barrel flange in a second direction opposite the first direction.
Description
SYRINGE ASSEMBLY AND ADAPTER FOR A SYRINGE
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Serial No. 62/213,511 filed September 2, 2015, is hereby claimed, and the disclosure thereof is hereby incorporated herein by reference.
FffiLD OF DISCLOSURE
[0002] The present disclosure generally relates to an adapter for a syringe, and more particularly, to an adapter that aids a user in handling and operating a syringe.
BACKGROUND
[0003] Syringes are devices for subcutaneous delivery of a medicament to a patient. Syringes typically include a barrel containing a medicament and a plunger movable through the barrel to discharge the medicament. Generally, a medically trained professional operates the syringe to administer the medicament to a patient. However, it has become increasingly common for patients to use syringes to self-administer their medicaments, particularly syringes pre-filled with a set dosage of medicament.
[0004] Handling a syringe can be challenging for inexperienced patients as well as elderly and infirm patients whose gripping strength and/or dexterity may be compromised. For example, patients may have difficulty gripping the syringe barrel while simultaneously pushing down on the plunger to administer the medicament. Additionally, patients may inadvertently withdraw the plunger from barrel, thereby compromising the sterility of the medicament and potentially causing it to leak from the barrel.
[0005] To address one or more of these challenges, it is possible to outfit a syringe with an adapter that assists the patient in handling the syringe. Typically such an adapter is provided as an add-on component which is attached to the syringe post-production. Therefore, the design of the syringe and/or its production line may not require modification.
[0006] To facilitate attachment of the adapter to the syringe, conventional adapters usually include a c-shaped gripping member having an aperture for receiving a barrel of the syringe. The aperture usually has an inner diameter that is less than or equal to an outer diameter of the
barrel so that the gripping member securely grasps the barrel. Due to this difference in diameters, however, the gripping member may strongly resist insertion of the barrel into the aperture.
[0007] Consequently, patients may find it difficult to push the barrel into the gripping member during assembly. Furthermore, it may be necessary to manufacture the aperture within relatively precise tolerances so that the gripping member securely grasp the barrel but without making it overly difficult to initially connect the gripping member to the barrel. Furthermore, in some situations, the grasping force provided by the gripping member may be insufficient to prevent the barrel from being inadvertently dislodged.
[0008] Accordingly, the present disclosure sets forth a syringe adapter that embodies advantageous alternatives to existing syringe adapters, and that may address one or more of the challenges or needs mentioned above, as well as provides other benefits and advantages.
SUMMARY
[0009] One aspect of the present disclosure provides an adapter for a syringe including a gripping member and a finger flange attached to the gripping member. The gripping member may have a proximal end and a distal end. A first aperture may extend between the proximal and distal ends along a longitudinal axis of the adapter. The first aperture may be configured to at least partially surround and engage at least a portion of a barrel of the syringe. The finger flange may be spaced apart from the proximal end of the gripping member along the longitudinal axis such that a cavity is defined between the finger flange and the proximal end of the gripping member. The cavity may be configured to receive a barrel flange extending outwardly from the barrel of the syringe. The proximal end of the gripping member may have a mounting surface for engaging the barrel flange when the barrel flange is positioned in the cavity. Additionally, the proximal end of the gripping member may have an inclined lead-in surface extending downwardly from the mounting surface. The inclined lead-in surface may be configured to guide the barrel flange into the cavity during assembly.
[0010] Another aspect of the present disclosure provides a syringe assembly including a syringe and an adapter for attachment to the syringe. The syringe may include a barrel configured to contain a medicament, a stopper, a plunger attached to the stopper and at least partially disposed outside the barrel, and a barrel flange protruding radially outwardly from the
barrel. The stopper may slidably engage an inner wall of the barrel and form a fluid-tight seal with the inner wall of the barrel. The plunger arm may be configured to move the stopper in a distal direction to discharge medicament from the barrel and a proximal direction to draw medicament into the barrel. The adapter may include a gripping member and a finger flange attached to the gripping member. The gripping member may have a proximal end, a distal end, and a first aperture extending between the proximal and distal ends. The first aperture may be configured to at least partially surround and engage at least a portion of the barrel. The finger flange may be spaced apart from a proximal end of the gripping member such that a cavity for receiving the barrel flange is defined between the finger flange and the proximal end of the gripping member. The proximal end of the gripping member may have a mounting surface for engaging the barrel flange when the barrel flange is positioned in the cavity. Additionally, the proximal end of the gripping member may have an inclined lead-in surface extending
downwardly from the mounting surface. The inclined lead-in surface may be configured to guide the barrel flange into the cavity during assembly.
[0011] Yet another aspect of the present disclosure provides an adapter for a syringe including a gripping member, a finger flange attached to the gripping member, and a snap fit locking mechanism at least partially disposed on the finger flange. The gripping member may have a proximal end and a distal end. A first aperture may extend between the proximal and distal ends along a longitudinal axis of the adapter. The first aperture may be configured to at least partially surround and engage at least a portion of a barrel of the syringe. The finger flange may be attached to the gripping member and spaced apart from the proximal end of the gripping member along the longitudinal axis such that a cavity is defined between the finger flange and the proximal end of the gripping member. The cavity may be configured to receive a barrel flange extending outwardly from the barrel of the syringe. The snap fit locking may be configured to engage the barrel flange. Additionally, the snap fit locking mechanism may allow the barrel flange to be inserted into the cavity in a first direction toward the longitudinal axis and resist removal of the barrel flange from the cavity in a second direction opposite the first direction.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the figures may
have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some figures are not necessarily indicative of the presence or absence of particular elements in any of the exemplary
embodiments, except as may be explicitly delineated in the corresponding written description. None of the drawings are necessarily to scale.
[0013] Fig. 1 is top front perspective view of one embodiment of a syringe assembly constructed in accordance with principles of the present disclosure;
[0014] Fig. 2 is top front perspective view of one embodiment of a syringe constructed in accordance with principles of the present disclosure;
[0015] Fig. 3 is bottom front perspective view of one embodiment of an adapter constructed in accordance with principles of the present disclosure;
[0016] Fig
[0017] Fig
[0018] Fig
[0019] Fig
[0020] Fig
[0021] Fig
DETAILED DESCRIPTION
[0022] The present disclosure generally concerns an adapter for improving the usability of a syringe. More particularly, an adapter is provided that can be attached to the syringe with relative ease and which reduces the likelihood of the syringe being inadvertently detached. The adapter may have one or more inclined lead-in surfaces which guide the syringe into the adapter and thereby reduce the force necessary to connect the adapter to the syringe. Furthermore, the adapter may include one or more locking tabs which securely retain the syringe once the syringe has been inserted into the adapter. Moreover, the inclined lead-in surfaces and/or locking tabs may provide a snap fit locking mechanism which is intuitive to use and relatively easy to manufacture.
[0023] Each of the foregoing components and advantages, and other components and advantages, of the adapter will be now be described in detail with reference to the accompanying figures.
[0024] Referring to Fig. 1, illustrated is one embodiment of a syringe assembly 10 constructed in accordance with principles of the present disclosure. The syringe assembly 10 includes a syringe 12 and an adapter 14 attached to an exterior of the syringe 12. The adapter 14 may initially be an accessory or separate component from the syringe 12. An end user (e.g., a patient, a doctor, a nurse, a pharmacist, etc.) or manufacturer may install the adapter 14 on the syringe 12. In general, the adapter 14 may improve the ergonomics and/or usability of the syringe 12 as compared to use of the syringe 12 without the adapter 14.
[0025] Turning to Fig. 2, the syringe 12 may include a barrel 20 (depicted here as being transparent) having an open proximal end 22 and an opposing distal end 24. The barrel 20 may have an inner wall 26 surrounding an internal bore 28, and an outer wall 30. The barrel 20 have a generally circular cross-sectional shape have an outer diameter Dl. The internal bore 28 may be contain a medicament (not illustrated) provided in a liquid or gelatin form, for example. A cannula 32 (e.g., a needle) may extend from the distal end 24 of the barrel 20 and possess an internal bore (not illustrated) that is in fluid communication with the internal bore 28 of the barrel 20. Additionally, the cannula 32 may have pointed distal end 33 for piercing the epidermis and/or other soft tissue of the patient.
[0026] The syringe 12 may further include a plunger 34 comprised of a plunger arm 36, a stopper 38 removably attached to a distal end of the plunger arm 36, and a thumb rest 40 fixed to a proximal end of the plunger arm 36. The plunger arm 36 may extend through the open proximal end 22 of the barrel 20 so that the stopper 38 and the thumb rest 40 are positioned, respectively, inside and outside the barrel 20. The stopper 38 may slidably engage, and form a fluid-tight seal with, the inner wall 26 of the barrel 20.
[0027] To discharge medicament from the barrel 20, a user may push down on the thumb rest 40 to move the stopper 38 in a distal direction through the internal bore 28. As the stopper 38 travels distally, medicament may be forced out of the distal end 24 of the barrel 20, through the internal bore of the cannula 32, and subsequently into the patient, if the pointed end 33 of the cannula 32 has been inserted subcutaneously. To draw medicament from a vial (not shown) or
another external container into the cannula 32, a user may pull up on the thumb rest 40, thereby moving the stopper 38 in a proximal direction through the internal bore 28. This action may create a vacuum capable of suctioning material through the internal bore of the cannula 32 and into the barrel 20.
[0028] Still referring to Fig. 2, a barrel flange 42 (depicted here as being transparent) may be disposed about and protrude radially outwardly from the proximal end 22 of the barrel 20. As described below in more detail, the barrel flange 42 may be received in a cavity of the adapter 14 when the adapter 14 is attached to the syringe 12. The barrel flange 42 may include a proximal end surface 44, a distal end surface 46, and an outer peripheral 48 surface extending between the proximal end surface 44 and the distal end surface 46. In an embodiment where the barrel flange 42 has a circular cross-sectional shape, the outer peripheral surface 48 may define the outer circumference of the barrel flange 42. Additionally, the barrel flange 42 may have a thickness T defined by the distance between the proximal end surface 44 and the distal end surface 46.
[0029] The adapter 14 will now be described in greater detail with reference to Figs. 3-9. As shown in Figs. 3 and 4, the adapter 14 includes a finger flange 50 and a gripping member 52. The finger flange 50 may have a proximal end 54 and a distal end 56, and the gripping member 52 may have a proximal end 58 and a distal end 59. The distal end 59 of the gripping member 52 may be connected to the distal end 56 of the finger flange 50. In some embodiments, the distal end 59 of the gripping member 52 and the distal end 56 of the finger flange 50 may be integrally formed as a single unitary body, whereas in other embodiments, they may be separate members joined together with an additional intermediate member (not illustrated).
[0030] The proximal end 58 of the gripping member 52 may be spaced apart from the proximal end 54 of the finger flange 50 along a longitudinal axis A of the adapter 14 such that a cavity 60 is defined between the proximal end 58 of the gripping member 52 and the proximal end 54 of the finger flange 50. As discussed below in more detail, the cavity 60 may receive the barrel flange 42 of the syringe 12 during assembly. The cavity 60 may have a height H defined by the distance separating the proximal end 58 of the gripping member 52 and the proximal end 54 of the finger flange 50. The height H may vary depending on the location where the height H is measured between the proximal end 58 of the gripping member 52 and the proximal end 54 of
the finger flange 50. Nevertheless, the height H at any location may be greater than or equal to the thickness T of the barrel flange 42.
[0031] When the barrel flange 42 is positioned in the cavity 60, at least a portion of the distal end surface 46 of the barrel flange 42 may engage an upwardly facing mounting surface 61 of the proximal end 58 of the gripping member 52. The mounting surface 61 may be substantially planar and coincident with an imaginary horizontal plane P (see Fig. 9) that is orthogonal to the longitudinal axis A. In some embodiments, the mounting surface 61 and a distal end surface 63 of the proximal end 54 of the finger flange 50 may face each other.
[0032] The distal end 56 of the finger flange 50 may include first and second finger plates 62 and 64 positioned on opposite sides of the gripping member 52 and which each extend outwardly away from the longitudinal axis A. The first and second finger plates 62 and 64 may possess, respectively, a first concave distal end surface 66 and a second concave distal end surface 68 which may help the user grip the finger flange 50 with his or her fingers when pushing down on the plunger 34 with his or her thumb to discharge the medicament from the barrel 20.
[0033] Referring to Figs. 5 and 6, a first aperture 70 may extend through a central portion of the gripping member 52 along the longitudinal axis A between the proximal and distal ends 58 and 60 of the gripping member 52. The first aperture 70 may have a generally circular cross- sectional shape and may be configured to at least partially surround and engage at least a portion of the barrel 20 when the adapter 14 is attached to the syringe 12 (see Fig. 1). The first aperture 70 may have a width Wl, which in some embodiments may correspond to an inner diameter of the first aperture 70, that is equal to or less than an outer diameter Dl of the barrel 20 so that a tight fit is formed between the gripping member 52 and the outer wall 30 of the barrel 20 when the barrel 20 is received in the first aperture 70. Accordingly, the gripping member 52 may squeeze and frictionally inhibit removal of the barrel 20 from the adapter 20 in a direction orthogonal to and away from the longitudinal axis A.
[0034] Still referring to Figs. 5 and 6, a second aperture 72 may extend through the proximal end 54 of the finger flange 50 along the longitudinal axis A, and may be at least partially aligned with the first aperture 70. The second aperture 72 may have a generally U-shaped cross- sectional shape which opens at its side through a front end 74 of the finger flange 50. When the gripping member 52 is attached to the barrel 20, the second aperture 72 may receive the plunger
arm 36. A width W2 of the second aperture 72, which in some embodiments may correspond to an inner diameter of the second aperture 72, may be greater than that of the plunger arm 36, thereby allowing the plunger arm 36 to reciprocate freely in the proximal and distal directions through the second aperture 72. However, the width W2 of the second aperture 72 may be less than a maximum width of the plunger 34, which in the present embodiment corresponds to an outer diameter D2 of the stopper 38. Accordingly, the stopper 38 may abut the proximal end 54 of the finger flange 50 if the plunger 34 is withdrawn past a certain point in the proximal direction. Therefore, the proximal end 54 of the finger flange 50 may function as a backstop that prevents, or at least inhibits, a user from inadvertently withdrawing the entire plunger 34 from the barrel 20. Thus, it is less likely that the sterility of the medicament will be comprised and/or that the medicament will leak from the open proximal end 22 of the barrel 20 as a result of the user accidentally removing the entire plunger 34 from the barrel 20.
[0035] Fig. 5 illustrates that, in addition to the first aperture 70, the gripping member 52 may include a third aperture 76 and a fourth aperture 78. Each of these apertures may extend through the gripping member 52 between the proximal and distal ends 58 and 60 of the gripping member 52. The third and fourth apertures 76 and 78 may be positioned on opposite sides of the first aperture 70 such that the third aperture 76 is positioned between the first aperture 70 and a rear end 82 of the gripping member 52, and the fourth aperture 78 is positioned between the first aperture 70 and a front end 84 of the gripping member 52.
[0036] The third aperture 76 may have a generally U-shaped cross-sectional shape which opens at its side into the first aperture 70, as shown in Fig. 5. A width W3 of the third aperture 76 may be less than the width Wl of the first aperture 70. The third aperture 76 may enable the gripping member 52 to expand radially outwardly, away from the longitudinal axis A, to accommodate the barrel 20 is the first aperture 70. In some embodiment, the gripping member 52, as well as the remainder of the adapter 14, may be made of a flexible and elastically deformable material such as an injection-molded polymer (e.g., polyethylene, polypropylene, polyurethane, etc.). Accordingly, the gripping member 52 may slightly deform when the adapter 14 is attached to the syringe 12 and regain its original shape if the syringe 12 is detached from the adapter 14.
[0037] Fig. 5 shows that the fourth aperture 78 may open, at opposite ends, into the first aperture 70 and the front end 84 of the gripping member 52. Furthermore, the fourth aperture 78 may have a width W4 which tapers (i.e., becomes increasingly smaller) as one moves from the front end 84 of the gripping member 52 toward the first aperture 70. Accordingly, the fourth aperture 78 may provide a corridor for guiding the barrel 20 into the first aperture 70 when the barrel 20 is inserted in a direction toward the longitudinal axis A through the front end 84 of the gripping member 52.
[0038] While the gripping member 52 squeezes the outer wall 30 of the barrel 20 to frictionally retain the barrel 20 in the first aperture 70, it is possible to detach the barrel 20 from the gripping member 52 by overcoming its frictional retaining force. While a user may intentionally detach the barrel 20 and gripping member 52, a risk exists that the barrel 20 and gripping member 52 may be accidentally detached. To lessen this risk, the adapter 14 may be provided with a snap fit locking mechanism 90 for retaining the barrel flange 42 in the cavity 60 when the adapter 14 is attached to the syringe 12. Accordingly, the snap fit locking mechanism 90 may assist the gripping member 52 in keeping the adapter 14 attached to the syringe 12. In embodiments where the gripping member 52 does not necessarily squeeze the barrel 20, the snap fit locking mechanism 90 may be the sole or primary means for securing the adapter 14 to the syringe 12.
[0039] With reference to Figs. 1, 3, 4, 5, 7, and 9, a more detailed explanation of one embodiment of the snap fit locking mechanism 90 will now be described. In general, the snap fit locking mechanism 90 may allow the barrel flange 42 to be inserted into the cavity 60 in a first direction toward the longitudinal axis A, and may resist removal of the barrel flange 42 from the cavity 60 in a second direction away from the longitudinal axis A which is opposite to the first direction. The snap fit locking mechanism 90 may be configured so that the force needed to insert the barrel flange 42 into the cavity 60 in the first direction may be significantly less than the force needed to remove the barrel flange 42 from the cavity 60 in the second direction.
[0040] In at least one embodiment, the snap fit locking mechanism 90 may include a first locking tab 92 and a second locking tab 94 each disposed on the proximal end 54 of the finger flange 50. The first and second locking tabs 92 and 94 may each extend from the distal end surface 63 of the proximal end 54 of the finger flange 50 in a generally downward vertical
direction toward the gripping member 52. In some embodiments, the snap fit locking mechanism 90 may additionally include a first inclined lead-in surface 98 and a second inclined lead-in surface 100 disposed on the proximal end 58 of the gripping member 52. In alternative embodiments, the inclined lead-in surfaces 98 and 100 may be omitted.
[0041] Referring to Figs. 4, 7, and 9, the first and second inclined lead-in surfaces 98 and 100 may each extend downwardly from the mounting surface 61 at an angle a relative to the horizontal plane P and terminate at the front end 84 of the gripping member 52. As noted above, the horizontal plane P may be orthogonal to the longitudinal axis A. The angle a may be any angle less than 90 degrees, and in some embodiments, may be in a range between approximately (e.g., +10%) 0 - 60 degrees, or 5 - 45 degrees, or 5 - 35 degrees, or 5 - 30 degrees, or 5 - 25 degrees, or 10 - 25 degrees, or 10 - 20 degrees. While the first and second inclined lead-in surfaces 98 and 100 of the present embodiment are substantially planar, in other embodiments, they may be curved and/or possess a convex shape. Also, as illustrated in Fig. 7, the first and second inclined lead-in surfaces 98 and 100 may be positioned on opposite sides of the longitudinal axis A.
[0042] The first and second inclined lead-in surfaces 98 and 100 each may function as a ramp that guides the barrel flange 42 up and into the cavity 60 during assembly of the adapter 14 and the syringe 12. More particularly, when a user pushes the barrel flange 42 in a horizontal direction that is orthogonal to the longitudinal axis A and toward the rear end 82 of the gripping member 52, the leading edge of the barrel flange 42 may contact the first and/or second inclined lead-in surfaces 98 and 100, which in turn may cause the barrel flange 42 to begin moving upwards in a vertical direction in addition to also moving in the horizontal direction.
Accordingly, the first and second inclined lead-in surfaces 98 and 100 may direct the barrel flange 42 up and into the cavity 60.
[0043] Still referring to Figs. 4, 7, and 9, the first locking tab 92 may include an outwardly facing surface 110, a downwardly facing surface 112, and an inwardly facing surface 114. The outwardly facing surface 110 may extend downwardly from the distal end surface 63 of the proximal end 54 of the finger flange 50 at an angle β relative to the horizontal plane P and terminate at the downwardly facing surface 112. The angle β may be any angle less than 90 degrees, and in some embodiments, may be in a range between approximately (e.g., +10%) 0 -
60 degrees, or 5 - 45 degrees, or 5 - 35 degrees, or 5 - 30 degrees, or 5 - 25 degrees, or 10 - 25 degrees, or 10 - 20 degrees. The outwardly facing surface 110 may be planar as illustrated in the figures, or it may possess a curvature and/or be convex. The outwardly facing surface 110 may function as a ramp the guides the barrel flange 42 downwards and into contact with the first and/or second inclined lead-in surfaces 98 and 100.
[0044] The inwardly facing surface 114, which may be positioned on an opposite side of the locking tab 92 as the outwardly facing surface 110, may define a portion of a perimeter of the cavity 60 and may be configured to engage the outer peripheral surface 48 of the barrel flange 42 when the entire barrel flange 42 is positioned in the cavity 60. In some embodiments, the inwardly facing surface 114 may have a contour that is substantially the same as a contour of the outer peripheral surface 48 of the barrel flange 42 so that the inwardly facing surface 114 is configured to flushly engage the outer peripheral surface 48 of the barrel flange 42. For example, the inwardly facing surface 114 may possess a radius of curvature of that is substantially the same as that of the outer peripheral surface 48 of the barrel flange 42.
[0045] In some embodiments, a depth X (Fig 9) of the cavity 60 (i.e., the horizontal distance between the inwardly facing surface 114 and a rear interior wall 130 of the finger flange 50) may be slightly less than a width W (Fig. 2) of the barrel flange 42 so that the inwardly facing surface 114 of the first locking tab 92 is configured to firmly press the barrel flange 42 against the rear interior wall 130 of the finger flange 50. Thus, following assembly, the barrel flange 42 may be squeezed between the inwardly facing surface 114 of the first locking tab 92 and the rear interior wall 130 of the finger flange 50. This may help retain the barrel flange 42 in the cavity 60. During assembly, the barrel flange 42 and/or the first locking tab 92 may elastically deform so that the barrel flange 42 can be accommodated in the cavity 60.
[0046] In some embodiments, a minimum clearance C (Fig. 9) between the downwardly facing surface 112 of the first locking tab 92 and the first inclined lead-in surface 98 may be less than or equal to the thickness T of the barrel flange 42. Accordingly, as the barrel flange 42 moves up the first inclined lead-in surface 98 during assembly, at least a portion of the downwardly facing surface 112 may contact the barrel flange 42 and squeeze it against the first inclined lead-in surface 98. As a result of this contact, the first locking tab 92, the barrel flange 42, and/or the gripping member 52 may elastically deform, thereby allowing the barrel flange 42
slip past the first locking tab 92 and continue moving up the first inclined lead-in surface 98 and into the cavity 60. If it is the first locking tab 92 or the gripping member 52 that elastically deforms during this process, the minimum clearance C may temporarily increase to allow the barrel flange 42 to pass between the downwardly facing surface 112 and the first inclined lead-in surface 98. When the entire barrel flange 42 is positioned in the cavity 60, the first locking tab 92, the barrel flange 42, and/or the gripping member 52 may expand and/or regain its original shape (i.e., snap back its original shape) and thereby inhibit the barrel flange 42 from moving back down the first inclined lead-in surface 98. Thus, removing the barrel flange 42 from the cavity 60 may require more force than inserting the barrel flange 42 into the cavity 60.
[0047] The second locking tab 94 may possess an outwardly facing surface 120, a
downwardly facing surface 122, and an inwardly facing surface 124 configured in the same manner as the outwardly facing surface 110, the downwardly facing surface 112, and the inwardly facing surface 114, respectively. Accordingly, the foregoing description about the structure and operation of the first locking tab 92 applies equally to the second locking tab 94.
[0048] From the foregoing, it can be seen that the present disclosure advantageously provides an adapter that securely engages a barrel flange of a syringe by utilizing a snap fit locking mechanism. The snap fit locking mechanism may supplement the means for gripping the outer wall of the barrel to retain the syringe. Accordingly, the snap fit locking mechanism may reduce the likelihood of the syringe being inadvertently detached from the adapter. In some
embodiments, the snap fit locking mechanism may be used as the sole or primary means for retaining the syringe in the adapter, which may provide more freedom in the design and manufacture of other components of the adapter such as its gripping member. Furthermore, the adapter may incorporate one or more inclined lead-in surface which may assist with inserting the barrel flange into the adapter.
[0049] The above description describes various systems, adapters, and methods for use with a syringe. It should be clear that the syringe can further comprise use of a medicament listed below with the caveat that the following list should neither be considered to be all inclusive nor limiting. The medicament will be contained in a reservoir (e.g., the barrel of the syringe). In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the medicament.
[0050] For example, the syringe or more specifically the reservoir of the syringe may be filled with colony stimulating factors, such as granulocyte colony- stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta®
(pegfilgrastim). In various other embodiments, the syringe may be used with various pharmaceutical products, such as an erythropoiesis stimulating agent (ESA), which may be in a liquid or a lyophilized form. An ESA is any molecule that stimulates erythropoiesis, such as Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta, and epoetin delta, as well as the molecules or variants or analogs thereof as disclosed in the following patents or patent applications, each of which is herein incorporated by reference in its entirety: U.S. Patent Nos. 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,986,047; 6,583,272; 7,084,245; and 7,271,689; and PCT Publication Nos. WO 91/05867; WO 95/05465; WO 96/40772; WO 00/24893; WO 01/81405; and WO 2007/136752.
[0051] An ESA can be an erythropoiesis stimulating protein. As used herein, "erythropoiesis stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta, and analogs thereof, pegylated erythropoietin, carbamylated erythropoietin, mimetic peptides (including EMP1 /hematide), and mimetic antibodies. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind and activate erythropoietin receptor (and include compounds reported in U.S. Publication Nos. 2003/0215444 and 2006/0040858, the disclosures of each of which is incorporated herein by reference in its entirety) as well as erythropoietin molecules or variants or analogs thereof as disclosed in the
following patents or patent applications, which are each herein incorporated by reference in its entirety: U.S. Patent Nos. 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086; 6,310,078;
6,391,633; 6,583,272; 6,586,398; 6,900,292; 6,750,369; 7,030,226; 7,084,245; and 7,217,689; U.S. Publication Nos. 2002/0155998; 2003/0077753; 2003/0082749; 2003/0143202;
2004/0009902; 2004/0071694; 2004/0091961; 2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824; 2004/0229318; 2004/0248815; 2004/0266690; 2005/0019914; 2005/0026834; 2005/0096461; 2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564; 2005/0137329; 2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822; 2005/0158832; 2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211; 2005/0202538; 2005/0227289; 2005/0244409; 2006/0088906; and 2006/0111279; and PCT Publication Nos. WO 91/05867; WO 95/05465; WO 99/66054; WO 00/24893; WO 01/81405; WO 00/61637; WO 01/36489; WO 02/014356; WO 02/19963; WO 02/20034; WO 02/49673; WO 02/085940; WO 03/029291; WO
2003/055526; WO 2003/084477; WO 2003/094858; WO 2004/002417; WO 2004/002424; WO 2004/009627; WO 2004/024761; WO 2004/033651; WO 2004/035603; WO 2004/043382; WO 2004/101600; WO 2004/101606; WO 2004/101611; WO 2004/106373; WO 2004/018667; WO 2005/001025; WO 2005/001136; WO 2005/021579; WO 2005/025606; WO 2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO 2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO 2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; and WO 2006/29094.
[0052] Examples of other pharmaceutical products for use with the device may include, but are not limited to, antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); other biological agents such as Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF), Neupogen® (filgrastim , G-CSF, hu-MetG-CSF), and Nplate® (romiplostim); small molecule drugs such as Sensipar® (cinacalcet). The device may also be used with a therapeutic antibody, a polypeptide, a protein or other chemical, such as an iron, for example, ferumoxytol, iron dextrans, ferric glyconate, and iron sucrose. The pharmaceutical product may be in liquid form, or reconstituted from lyophilized form.
[0053] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof:
[0054] OPGL specific antibodies, peptibodies, and related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies, including but not limited to the antibodies described in PCT Publication No. WO 03/002713, which is incorporated herein in its entirety as to OPGL specific antibodies and antibody related proteins, particularly those having the sequences set forth therein, particularly, but not limited to, those denoted therein: 9H7; 18B2; 2D8; 2E11; 16E1; and 22B3, including the OPGL specific antibodies having either the light chain of SEQ ID NO:2 as set forth therein in Figure 2 and/or the heavy chain of SEQ ID NO:4, as set forth therein in Figure 4, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
[0055] Myostatin binding proteins, peptibodies, and related proteins, and the like, including myostatin specific peptibodies, particularly those described in U.S. Publication No.
2004/0181033 and PCT Publication No. WO 2004/058988, which are incorporated by reference herein in their entirety particularly in parts pertinent to myostatin specific peptibodies, including but not limited to peptibodies of the mTN8-19 family, including those of SEQ ID NOS:305-351, including TN8-19-1 through TN8-19-40, TN8-19 conl and TN8-19 con2; peptibodies of the mL2 family of SEQ ID NOS:357-383; the mL15 family of SEQ ID NOS:384-409; the mL17 family of SEQ ID NOS:410-438; the mL20 family of SEQ ID NOS:439-446; the mL21 family of SEQ ID NOS:447-452; the mL24 family of SEQ ID NOS:453-454; and those of SEQ ID
NOS:615-631, each of which is individually and specifically incorporated by reference herein in their entirety fully as disclosed in the foregoing publication;
[0056] IL-4 receptor specific antibodies, peptibodies, and related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and/or IL-13 to the receptor, including those described in PCT Publication No. WO 2005/047331 or PCT Application No. PCT/US2004/37242 and in U.S. Publication No. 2005/112694, which are incorporated herein by reference in their entirety particularly in parts pertinent to IL-4 receptor specific antibodies, particularly such antibodies as are described therein, particularly, and without limitation, those designated therein: L1H1; L1H2; L1H3; L1H4; L1H5; L1H6; L1H7; L1H8; L1H9; L1H10; LlHl l; L2H1; L2H2; L2H3; L2H4; L2H5; L2H6; L2H7; L2H8; L2H9; L2H10; L2H11; L2H12;
L2H13; L2H14; L3H1; L4H1; L5H1; L6H1, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
[0057] Interleukin 1-receptor 1 ("IL1-R1") specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in U.S. Publication No.
2004/097712, which is incorporated herein by reference in its entirety in parts pertinent to IL1- Rl specific binding proteins, monoclonal antibodies in particular, especially, without limitation, those designated therein: 15CA, 26F5, 27F2, 24E12, and 10H7, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the aforementioned publication;
[0058] Ang2 specific antibodies, peptibodies, and related proteins, and the like, including but not limited to those described in PCT Publication No. WO 03/057134 and U.S. Publication No. 2003/0229023, each of which is incorporated herein by reference in its entirety particularly in parts pertinent to Ang2 specific antibodies and peptibodies and the like, especially those of sequences described therein and including but not limited to: L1(N); L1(N) WT; L1(N) IK WT; 2xLl(N); 2xLl(N) WT; Con4 (N), Con4 (N) IK WT, 2xCon4 (N) IK; L1C; L1C IK; 2xLlC; Con4C; Con4C IK; 2xCon4C IK; Con4-Ll (N); Con4-LlC; TN-12-9 (N); C17 (N); TN8-8(N); TN8-14 (N); Con 1 (N), also including anti-Ang 2 antibodies and formulations such as those described in PCT Publication No. WO 2003/030833 which is incorporated herein by reference in its entirety as to the same, particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558; Ab559; Ab565;
AbFlAbFD; AbFE; AbFJ; AbFK; AbGlD4; AbGClE8; AbHlC12; AblAl; AblF; AblK, AblP; and AblP, in their various permutations as described therein, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
[0059] NGF specific antibodies, peptibodies, and related proteins, and the like including, in particular, but not limited to those described in U.S. Publication No. 2005/0074821 and U.S. Patent No. 6,919,426, which are incorporated herein by reference in their entirety particularly as to NGF-specific antibodies and related proteins in this regard, including in particular, but not limited to, the NGF-specific antibodies therein designated 4D4, 4G6, 6H9, 7H2, 14D10 and
14D11, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
[0060] CD22 specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Patent No. 5,789,554, which is incorporated herein by reference in its entirety as to CD22 specific antibodies and related proteins, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human antibodies, including but not limited to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, for instance, a dimer of a human-mouse monoclonal hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa- chain, including, but limited to, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0;
[0061] IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like, such as those described in PCT Publication No. WO 06/069202, which is incorporated herein by reference in its entirety as to IGF-1 receptor specific antibodies and related proteins, including but not limited to the IGF-1 specific antibodies therein designated L1H1, L2H2, L3H3, L4H4, L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21H21, L22H22, L23H23, L24H24, L25H25, L26H26, L27H27, L28H28, L29H29, L30H30, L31H31, L32H32, L33H33, L34H34, L35H35, L36H36, L37H37, L38H38, L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45, L46H46, L47H47, L48H48, L49H49, L50H50, L51H51, L52H52, and IGF-lR-binding fragments and derivatives thereof, each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
[0062] Also among non-limiting examples of anti-IGF-lR antibodies for use in the methods and compositions of the present invention are each and all of those described in:
(i) U.S. Publication No. 2006/0040358 (published February 23, 2006), 2005/0008642 (published January 13, 2005), 2004/0228859 (published November 18, 2004), including but not limited to, for instance, antibody 1A (DSMZ Deposit No. DSM ACC 2586), antibody 8 (DSMZ Deposit No. DSM ACC 2589), antibody 23 (DSMZ Deposit No. DSM ACC 2588) and antibody 18 as described therein;
(ii) PCT Publication No. WO 06/138729 (published December 28, 2006) and WO 05/016970 (published February 24, 2005), and Lu et al. (2004), J. Biol. Chem. 279:2856-2865, including but not limited to antibodies 2F8, A12, and JJVIC-A12 as described therein;
(iii) PCT Publication No. WO 07/012614 (published February 1, 2007), WO 07/000328 (published January 4, 2007), WO 06/013472 (published February 9, 2006), WO 05/058967 (published June 30, 2005), and WO 03/059951 (published July 24, 2003);
(iv) U.S. Publication No. 2005/0084906 (published April 21, 2005), including but not limited to antibody 7C10, chimaeric antibody C7C10, antibody h7C10, antibody 7H2M, chimaeric antibody *7C10, antibody GM 607, humanized antibody 7C10 version 1, humanized antibody 7C10 version 2, humanized antibody 7C10 version 3, and antibody 7H2HM, as described therein;
(v) U.S. Publication Nos. 2005/0249728 (published November 10, 2005), 2005/0186203 (published August 25, 2005), 2004/0265307 (published December 30, 2004), and 2003/0235582 (published December 25, 2003) and Maloney et al. (2003), Cancer Res. 63:5073-5083, including but not limited to antibody EM 164, resurfaced EM 164, humanized EM 164, huEM164 vl.O, huEM164 vl. l, huEM164 vl.2, and huEM164 v 1.3 as described therein;
(vi) U.S. Patent No. 7,037,498 (issued May 2, 2006), U.S. Publication Nos.
2005/0244408 (published November 30, 2005) and 2004/0086503 (published May 6, 2004), and Cohen, et al. (2005), Clinical Cancer Res. 11:2063-2073, e.g., antibody CP-751,871, including but not limited to each of the antibodies produced by the hybridomas having the ATCC accession numbers PTA-2792, PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793, and antibodies 2.12.1, 2.13.2, 2.14.3, 3.1.1, 4.9.2, and 4.17.3, as described therein;
(vii) U.S. Publication Nos. 2005/0136063 (published June 23, 2005) and 2004/0018191 (published January 29, 2004), including but not limited to antibody 19D12 and an antibody comprising a heavy chain encoded by a polynucleotide in plasmid 15H12/19D12 HCA (γ4), deposited at the ATCC under number PTA-5214, and a light chain encoded by a polynucleotide in plasmid 15H12/19D12 LCF (κ), deposited at the ATCC under number PTA-5220, as described therein; and
(viii) U.S. Publication No. 2004/0202655 (published October 14, 2004), including but not limited to antibodies PINT-6A1, PINT-7A2, PINT-7A4, PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1, PINT-11A2, PINT-11A3, PINT-11A4, PINT-11A5, PINT-11A7, PINT- 11A12, PINT-12A1, PINT-12A2, PINT-12A3, PINT-12A4, and PINT-12A5, as described therein; each and all of which are herein incorporated by reference in their entireties, particularly as to the aforementioned antibodies, peptibodies, and related proteins and the like that target IGF-1 receptors;
[0063] B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like ("B7RP-1," also is referred to in the literature as B7H2, ICOSL, B7h, and CD275), particularly B7RP-specific fully human monoclonal IgG2 antibodies, particularly fully human IgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, especially those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells in particular, especially, in all of the foregoing regards, those disclosed in U.S. Publication No. 2008/0166352 and PCT Publication No. WO 07/011941, which are incorporated herein by reference in their entireties as to such antibodies and related proteins, including but not limited to antibodies designated therein as follow: 16H (having light chain variable and heavy chain variable sequences SEQ ID NO: l and SEQ ID NO:7 respectively therein); 5D (having light chain variable and heavy chain variable sequences SEQ ID NO:2 and SEQ ID NO:9 respectively therein); 2H (having light chain variable and heavy chain variable sequences SEQ ID NO:3 and SEQ ID NO: 10 respectively therein); 43H (having light chain variable and heavy chain variable sequences SEQ ID NO:6 and SEQ ID NO: 14 respectively therein); 41H (having light chain variable and heavy chain variable sequences SEQ ID NO:5 and SEQ ID NO: 13 respectively therein); and 15H (having light chain variable and heavy chain variable sequences SEQ ID NO:4 and SEQ ID NO: 12 respectively therein), each of which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication;
[0064] IL-15 specific antibodies, peptibodies, and related proteins, and the like, such as, in particular, humanized monoclonal antibodies, particularly antibodies such as those disclosed in U.S. Publication Nos. 2003/0138421; 2003/023586; and 2004/0071702; and U.S. Patent No. 7,153,507, each of which is incorporated herein by reference in its entirety as to IL-15 specific
antibodies and related proteins, including peptibodies, including particularly, for instance, but not limited to, HuMax IL-15 antibodies and related proteins, such as, for instance, 146B7;
[0065] IFN gamma specific antibodies, peptibodies, and related proteins and the like, especially human IFN gamma specific antibodies, particularly fully human anti-IFN gamma antibodies, such as, for instance, those described in U.S. Publication No. 2005/0004353, which is incorporated herein by reference in its entirety as to IFN gamma specific antibodies, particularly, for example, the antibodies therein designated 1118; 1118*; 1119; 1121; and 1121*. The entire sequences of the heavy and light chains of each of these antibodies, as well as the sequences of their heavy and light chain variable regions and complementarity determining regions, are each individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publication and in Thakur et al. (1999), Mol. Immunol. 36: 1107-1115. In addition, description of the properties of these antibodies provided in the foregoing publication is also incorporated by reference herein in its entirety. Specific antibodies include those having the heavy chain of SEQ ID NO: 17 and the light chain of SEQ ID NO: 18; those having the heavy chain variable region of SEQ ID NO:6 and the light chain variable region of SEQ ID NO:8; those having the heavy chain of SEQ ID NO: 19 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO: 10 and the light chain variable region of SEQ ID NO: 12; those having the heavy chain of SEQ ID NO:32 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO:30 and the light chain variable region of SEQ ID NO: 12; those having the heavy chain sequence of SEQ ID NO:21 and the light chain sequence of SEQ ID NO:22; those having the heavy chain variable region of SEQ ID NO: 14 and the light chain variable region of SEQ ID NO: 16; those having the heavy chain of SEQ ID NO:21 and the light chain of SEQ ID NO:33; and those having the heavy chain variable region of SEQ ID NO: 14 and the light chain variable region of SEQ ID NO:31, as disclosed in the foregoing publication. A specific antibody contemplated is antibody 1119 as disclosed in the foregoing U.S. publication and having a complete heavy chain of SEQ ID NO: 17 as disclosed therein and having a complete light chain of SEQ ID NO: 18 as disclosed therein;
[0066] TALL-1 specific antibodies, peptibodies, and the related proteins, and the like, and other TALL specific binding proteins, such as those described in U.S. Publication Nos.
2003/0195156 and 2006/0135431, each of which is incorporated herein by reference in its entirety as to TALL-1 binding proteins, particularly the molecules of Tables 4 and 5B, each of
which is individually and specifically incorporated by reference herein in its entirety fully as disclosed in the foregoing publications;
[0067] Parathyroid hormone ("PTH") specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Patent No. 6,756,480, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind PTH;
[0068] Thrombopoietin receptor ("TPO-R") specific antibodies, peptibodies, and related proteins, and the like, such as those described in U.S. Patent No. 6,835,809, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TPO-
R;
[0069] Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, and related proteins, and the like, including those that target the HGF/SF:cMet axis (HGF/SF:c-Met), such as the fully human monoclonal antibodies that neutralize hepatocyte growth factor/scatter
(HGF/SF) described in U.S. Publication No. 2005/0118643 and PCT Publication No. WO 2005/017107, huL2G7 described in U.S. Patent No. 7,220,410 and OA-5d5 described in U.S. Patent Nos. 5,686,292 and 6,468,529 and in PCT Publication No. WO 96/38557, each of which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind HGF;
[0070] TRAIL-R2 specific antibodies, peptibodies, related proteins and the like, such as those described in U.S. Patent No. 7,521,048, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TRAIL-R2;
[0071] Activin A specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2009/0234106, which is herein
incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind Activin A;
[0072] TGF-beta specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Patent No. 6,803,453 and U.S. Publication No.
2007/0110747, each of which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind TGF-beta;
[0073] Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in PCT Publication No. WO 2006/081171, which is herein incorporated by reference in its entirety, particularly in parts pertinent to proteins that bind amyloid-beta proteins. One antibody contemplated is an antibody having a heavy chain variable region comprising SEQ ID NO:8 and a light chain variable region having SEQ ID NO:6 as disclosed in the foregoing publication;
[0074] c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2007/0253951, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind c-Kit and/or other stem cell factor receptors;
[0075] OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in U.S. Publication No. 2006/0002929, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind OX40L and/or other ligands of the OX40 receptor; and
[0076] Other exemplary proteins, including Activase® (alteplase, tPA); Aranesp®
(darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta- la); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta);
Velcade® (bortezomib); MLN0002 (anti- a4B7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, TNF-receptor /Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HERl / c-ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb); Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF);
LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti- BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol- epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia®
(certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio®
(lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM- 1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DMl);
NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Neulasta® (pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF); Neupogen® (filgrastim , G- CSF, hu-MetG-CSF); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP lib/Ilia receptor monoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 146B7-CHO (anti-IL15 antibody, see U.S. Patent No. 7,153,507); Tysabri® (natalizumab, anti-a4integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Vectibix® (panitumumab); Xolair®
(omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgGl and the extracellular domains of both IL- 1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgGl Fc); Zenapax®
(daclizumab); Zenapax® (daclizumab, anti-IL-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody
(galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor- 1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5pi integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; anti-C. difficile Toxin A and Toxin B C mAbs MDX-066 (CDA-1) and MDX-1388); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI- 0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF Idiopathic Pulmonary Fibrosis Phase I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxinl mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; anti-ganglioside GM2 mAb; anti-GDF-8 human mAb (MYO- 029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-IFNa mAb (MEDI-545, MDX-1103); anti-IGFIR mAb; anti-IGF-lR mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra
mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptors mAb (MDX-018, CNTO 95); anti-IPIO Ulcerative Colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513; anti- Mannose Receptor/hCGP mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT- 5001); anti-PDlmAb (MDX-1106 (ONO-4538)); anti-PDGFRa antibody (IMC-3G3); anti-TGFB mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti- VEGFR/Flt-1 mAb; anti-ZP3 mAb (HuMax-ZP3); NVS Antibody #1; and NVS Antibody #2.
[0077] Also included can be a sclerostin antibody, such as but not limited to romosozumab, blosozumab, or BPS 804 (Novartis). Further included can be therapeutics such as rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant, panitumumab, denosumab, NPLATE, PROLIA, VECTIBIX or XGEVA.
Additionally, included in the device can be a monoclonal antibody (IgG) that binds human Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9), e.g. U.S. Patent No. 8,030,547, U.S. Publication No. 2013/0064825, WO2008/057457, WO2008/057458, WO2008/057459,
WO2008/063382, WO2008/133647, WO2009/ 100297, WO2009/100318, WO2011/037791, WO2011/053759, WO2011/053783, WO2008/125623, WO2011/072263, WO2009/055783, WO2012/0544438, WO2010/029513, WO2011/111007, WO2010/077854, WO2012/088313, WO2012/101251, WO2012/101252, WO2012/101253, WO2012/109530, and WO2001/031007.
[0078] Also included can be talimogene laherparepvec or another oncolytic HSV for the treatment of melanoma or other cancers. Examples of oncolytic HSV include, but are not limited to talimogene laherparepvec (U.S. Patent Nos. 7,223,593 and 7,537,924); OncoVEXGALV/CD (U.S. Pat. No. 7,981,669); OrienXOlO (Lei et al. (2013), World J. Gastroenterol., 19:5138-5143); G207, 1716; NV1020; NV12023; NV1034 and NV1042 (Vargehes et al. (2002), Cancer Gene Ther., 9(12):967-978).
[0079] Also included are TIMPs. TIMPs are endogenous tissue inhibitors of
metalloproteinases (TIMPs) and are important in many natural processes. TIMP-3 is expressed by various cells or and is present in the extracellular matrix; it inhibits all the major cartilage- degrading metalloproteases, and may play a role in role in many degradative diseases of connective tissue, including rheumatoid arthritis and osteoarthritis, as well as in cancer and cardiovascular conditions. The amino acid sequence of TIMP-3, and the nucleic acid sequence of a DNA that encodes TIMP-3, are disclosed in U.S. Patent No. 6,562,596, issued May 13,
2003, the disclosure of which is incorporated by reference herein. Description of TIMP mutations can be found in U.S. Publication No. 2014/0274874 and PCT Publication No. WO 2014/152012.
[0080] Also included are antagonistic antibodies for human calcitonin gene-related peptide (CGRP) receptor and bispecific antibody molecule that target the CGRP receptor and other headache targets. Further information concerning these molecules can be found in PCT
Application No. WO 2010/075238.
[0081] Additionally, a bispecific T cell engager antibody (BiTe), e.g. Blinotumomab can be used in the device. Alternatively, included can be an APJ large molecule agonist e.g., apelin or analogues thereof in the device. Information relating to such molecules can be found in PCT Publication No. WO 2014/099984.
[0082] In certain embodiments, the medicament comprises a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or TSLP receptor antibody. Examples of anti- TSLP antibodies that may be used in such embodiments include, but are not limited to, those described in U.S. Patent Nos. 7,982,016, and 8,232,372, and U.S. Publication No.
2009/0186022. Examples of anti-TSLP receptor antibodies include, but are not limited to, those described in U.S. Patent No. 8,101,182. In particularly preferred embodiments, the medicament comprises a therapeutically effective amount of the anti-TSLP antibody designated as A5 within U.S. Patent No. 7,982,016.
[0083] It should be noted that the configurations of the various embodiments of the syringe assembly, syringe, and adapter described herein are illustrative only. Although only a few embodiments of the of the syringe assembly, syringe, and adapter have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter of this disclosure. Also, the order or sequence of any process or method steps described herein may be varied or re-sequenced, in any combination, according to alternative embodiments. Furthermore, any combination of one or more of the elements of one or more of the claims set forth at the end of this disclosure is possible.
Although the preceding text sets forth a detailed description of different embodiments of the invention, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the invention because describing every possible embodiment would be impractical, if not impossible. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, that would still fall within the scope of the claims defining the invention.
Claims
1. An adapter for a syringe, the adapter comprising:
a gripping member having a proximal end, a distal end, and a first aperture extending between the proximal and distal ends along a longitudinal axis of the adapter;
the first aperture being configured to at least partially surround and engage at least a portion of a barrel of the syringe; and
a finger flange attached to the gripping member and spaced apart from the proximal end of the gripping member along the longitudinal axis such that a cavity is defined between the finger flange and the proximal end of the gripping member,
the cavity being configured to receive a barrel flange extending outwardly from the barrel of the syringe,
the proximal end of the gripping member having at least one mounting surface for engaging the barrel flange when the barrel flange is positioned in the cavity and at least one inclined lead-in surface extending downwardly from the mounting surface, each inclined lead-in surface being configured to guide the barrel flange into the cavity during assembly.
2. The adapter of claim 1, at least a portion of the inclined lead-in surface forming an angle of less than 90 degrees with a horizontal plane orthogonal to the longitudinal axis.
3. The adapter of any one of claims 1 to 2, comprising a locking tab disposed on the finger flange and having an inwardly facing surface configured to engage and secure the barrel flange when the barrel flange is positioned in the cavity.
4. The adapter of claim 3, each locking tab extending downwardly from the finger flange and terminating above at least a portion of the inclined lead-in surface.
5. The adapter of any one of claims 3 to 4, each locking tab having an outwardly facing surface extending downwardly from the finger flange at an angle.
6. The adapter of claim 5, at least a portion of the outwardly facing surface of each locking tab forming an angle of less than 90 degrees with a horizontal plane orthogonal to the longitudinal axis.
7. The adapter of any one of claims 1 to 6, the first aperture having a width equal to or less than an outer diameter of the barrel of the syringe.
8. The adapter of any one of claims 1 to 7, comprising a second aperture extending through the finger flange along the longitudinal axis such that the second aperture is at least partially aligned with the first aperture.
9. The adapter of claim 8, the second aperture having a width less than the width of the first aperture and less than a maximum width of a plunger of the syringe.
10. The adapter of any one of claims 1 to 9, the finger flange including a first and a second finger plate arranged on opposite sides of the finger flange and each extending outwardly away from the longitudinal axis.
11. The adapter of any one of claims 1 to 10, comprising a third and a fourth aperture arranged on opposite sides of the first aperture and each extending between the proximal and distal ends of the gripping member, the first aperture being wider than the third aperture.
12. A syringe assembly comprising:
a syringe including:
a barrel configured to contain a medicament;
a stopper slidably engaging an inner wall of the barrel and forming a fluid-tight seal with the inner wall of the barrel;
a plunger arm attached to the stopper and at least partially disposed outside the barrel, the plunger arm being configured to move the stopper in a distal direction to discharge medicament from the barrel and a proximal direction to draw medicament into the barrel; and a barrel flange protruding outwardly from the barrel; and
an adapter for attachment to the syringe, the adapter including:
a gripping member having a proximal end, a distal end, and a first aperture extending between the proximal and distal ends, the first aperture being configured to at least partially surround and engage at least a portion of the barrel; and
a finger flange attached to the gripping member and spaced apart from a proximal end of the gripping member such that a cavity for receiving the barrel flange is defined between the finger flange and the proximal end of the gripping member,
the proximal end of the gripping member including at least one mounting surface for engaging a distal end surface of the barrel flange when the barrel flange is positioned in the cavity and at least one inclined lead-in surface extending downwardly from the mounting surface, each inclined lead-in surface being configured to guide the barrel flange into the cavity during assembly.
13. The syringe assembly of claim 12, at least a portion of the inclined lead-in surface forming an angle of less than 90 degrees with a horizontal plane orthogonal to the longitudinal axis.
14. The syringe assembly of any one of claims 12 to 13, a first and a second locking tab each extending downwardly from the finger flange and each including an inwardly facing surface configured to engage an outer peripheral surface of the barrel flange when the barrel flange is positioned in the cavity.
15. The syringe assembly of claim 14, each locking tab comprising an outwardly facing surface extending downwardly from the finger flange at an angle, at least a portion of each outwardly facing surface forming an angle of less than 90 degrees with a horizontal plane orthogonal to the longitudinal axis.
16. The syringe assembly of any one of claims 12 to 15, the first aperture having a width equal to or less than an outer diameter of the barrel.
17. The syringe assembly of claim 16, comprising:
a second aperture extending through the finger flange;
the plunger arm being movable through the first and second apertures when the adapter is attached to the syringe; and
the second aperture having a width less than a maximum width of the stopper so that the finger flange engages and resists removal of the stopper from the barrel in the proximal direction.
18. An adapter for a syringe, the adapter comprising:
a gripping member having a proximal end, a distal end, and a first aperture extending between the proximal and distal ends along a longitudinal axis of the adapter,
the first aperture being configured to at least partially surround and engage at least a portion of a barrel of the syringe; and
a finger flange attached to the gripping member and spaced apart from the proximal end of the gripping member along the longitudinal axis such that a cavity is defined between the finger flange and the proximal end of the gripping member,
the cavity being configured to receive a barrel flange extending outwardly from the barrel of the syringe, and
the snap fit locking mechanism at least partially disposed on the finger flange and configured to engage the barrel flange, the snap fit locking mechanism allowing the barrel flange to be inserted into the cavity in a first direction toward the longitudinal axis and resisting removal of the barrel flange from the cavity in a second direction opposite the first direction.
19. The adapter of claim 18, the snap fit locking mechanism including an inclined lead- in surface disposed on the proximal end of the gripping member, the inclined lead-in surface being arranged below the first and second locking tabs.
20. The adapter of claim 19, at least a portion of the inclined lead-in surface forming an angle of less than 90 degrees with a horizontal plane orthogonal to the longitudinal axis.
21. The adapter of any one of claims 18 to 20, the snap fit locking mechanism including a first and a second locking tab each extending downwardly from the finger flange and each
including an inwardly facing surface configured to engage the barrel flange when the barrel flange is positioned in the cavity.
22. The adapter of claim 21, each locking tab comprising an outwardly facing surface extending downwardly from the finger flange at an angle, at least a portion of each outwardly facing surface forming an angle of less than 90 degrees with a horizontal plane orthogonal to the longitudinal axis.
23. The adapter of any one of claims 21 to 22, the inwardly facing surface of each of the first and second locking tabs being configured to engage an outer peripheral surface of the barrel flange and each having a contour corresponding to that of the outer peripheral surface of the barrel flange.
24. The adapter of any one of claims 18 to 23, the first aperture having a width equal to or less than an outer diameter of the barrel of the syringe.
25. The adapter of any one of claims 18 to 24, a second aperture extending through the finger flange along the longitudinal axis, the second aperture having a width less than the width of the first aperture and less than a maximum width of a plunger of the syringe.
Applications Claiming Priority (2)
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US201562213511P | 2015-09-02 | 2015-09-02 | |
US62/213,511 | 2015-09-02 |
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PCT/US2016/038337 WO2017039786A1 (en) | 2015-09-02 | 2016-06-20 | Syringe assembly adapter for a syringe |
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WO2022178140A1 (en) * | 2021-02-18 | 2022-08-25 | Bobby Nourani | Ergonomic syringe adaptor |
WO2022260925A1 (en) | 2021-06-08 | 2022-12-15 | Amgen Inc. | Drug delivery devices, finger-grip elements, and related methods |
US20230147715A1 (en) * | 2019-02-22 | 2023-05-11 | Credence Medsystems, Inc. | System and method for safety syringe |
USD987819S1 (en) | 2021-02-18 | 2023-05-30 | Bobby Nourani | Syringe holder |
USD987818S1 (en) | 2019-12-04 | 2023-05-30 | Bobby Nourani | Syringe adaptor |
EP4098298A4 (en) * | 2020-03-24 | 2023-07-19 | TERUMO Kabushiki Kaisha | Syringe-barrel grip, barrel assembly, and syringe |
WO2023163816A1 (en) * | 2022-02-28 | 2023-08-31 | Minhong Yu | Threadless plunger rod and backstop for syringe assembly |
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