US20200338257A1 - Medical vial and injector assemblies and methods of use - Google Patents
Medical vial and injector assemblies and methods of use Download PDFInfo
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- US20200338257A1 US20200338257A1 US16/923,612 US202016923612A US2020338257A1 US 20200338257 A1 US20200338257 A1 US 20200338257A1 US 202016923612 A US202016923612 A US 202016923612A US 2020338257 A1 US2020338257 A1 US 2020338257A1
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- vial
- needle
- injection
- skin
- bladder
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Images
Classifications
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- 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
-
- 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
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
- A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
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- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
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- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
-
- 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
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
- A61M5/152—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags pressurised by contraction of elastic reservoirs
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- 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
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
Definitions
- FIG. 1 is a cross-sectional view of a preferred embodiment of the present invention. In this view, the vial assembly is shown in the unfilled state.
- FIG. 2 is a cross-sectional view of a preferred embodiment of the present invention. In this view, the vial assembly is shown in the filled state.
- FIGS. 3-4 are cross-sectional views of the vial assembly being filled with a syringe and vial adapter.
- the vial assembly is shown in the unfilled state in FIG. 3 and shown in the filled state in FIG. 4 .
- FIGS. 7-14 are cross-sectional views of the preferred embodiment of the present invention of the injector assembly with vial assembly in place showing different sequences during the injection.
- FIG. 15 is a perspective view of the preferred embodiment of the present invention of the injector assembly being removed from the injection surface after delivery of the liquid.
- FIG. 16 is a perspective view of an alternative embodiment. In this view the filled vial assembly is being inserted into the injector assembly.
- FIG. 17 is cross-sectional view of FIG. 16 .
- FIGS. 18-22 are cross-sectional views of an alternative embodiment of the injector assembly with vial assembly in place showing different sequences during the injection.
- FIG. 24 is a perspective view of an alternative embodiment of an injector assembly. In this view the filled vial assembly is being inserted into the injector assembly.
- FIG. 25 is cross-sectional view of FIG. 24 .
- FIGS. 26-29 are cross-sectional views of an alternative embodiment of the injector assembly with vial assembly in place showing different sequences during the injection.
- FIG. 30 is a perspective view of an alternative embodiment of the injector assembly being removed from the injection surface (e.g. patient's skin) after delivery of the liquid.
- FIG. 31 is a perspective view of a vial such as in FIG. 1 and a filling apparatus or spike for introducing medical liquid into the vial.
- FIG. 32 is a cross-sectional perspective view of the vial of FIG. 31 with filling apparatus fully inserted.
- FIG. 33 is a cross-sectional perspective view of the vial of FIG. 32 , with the filling apparatus partially withdrawn or partially inserted.
- FIG. 34 is a cross-sectional perspective view of the vial of FIG. 33 , with the filling apparatus further withdrawn or less inserted.
- the vial assembly 5 may include a vial 1 , outer stopper/bladder 2 , inner plug 3 and crimp cap 4 .
- the vial 1 may be constructed from glass or plastic and range in volume from 1 mL to 10 mL.
- the crimp cap 4 can be constructed from plastic, aluminum or steel and may include an optional pop-off safety tab. The crimp cap 4 could fit a range of vial neck sizes from 13 to 32 mm in diameter.
- the outer stopper/bladder 2 (also known as the outer expanding element or balloon) and inner plug 3 can be made from blended synthetic rubber. They may also be independently different materials.
- the outer stopper/bladder 2 and inner plug 3 may be made from a thermoplastic elastomer.
- the outer stopper/bladder 2 may have irregular wall thickness both in the axial and circumferential direction including ribs or grooves to provide intended variations in stress as a function of strain. This would allow for control over the pressure profile to control the delivery flow rate as a function of diameter extension.
- the assembly of the vial 1 may include a sub-assembly of the inner plug 3 and outer stopper/bladder 2 prior to insertion into the vial 1 .
- the outer stopper/bladder 2 can be assembled into the vial 1 and then the inner plug 3 assembled into the outer stopper/bladder 2 .
- the crimp cap 4 is placed onto the vial 1 .
- the crimp force applied by the crimp cap 4 can be varied to achieve different compression forces on the outer stopper/bladder 2 and inner plug 3 assembly. This may allow for control of the seal performance or venting function.
- the inner plug 3 is configured or sized to provide a pre-stress on the outer stopper/bladder 2 to control the pressure profile as well as to aid in delivery of all or substantially all of the liquid contained within the outer stopper/bladder 2 , preferably at about a constant flow rate for most of the injection.
- a pre-stress between the inner plug 3 and outer stopper/bladder 2 can be created by making the outer diameter of the inner plug 3 larger than inner diameter of the outer stopper/bladder 2 .
- the inner plug 3 could be a solid piece of material or could be expandable element to control the amount of pre-stress. Gas or liquid could be introduced into a void formed within the inner plug 3 to change its outer diameter or length thus causing varying amounts of pre-stress. Alternatively or additionally, pre-stress can be created by making the inner plug 3 longer than the outer stopper/bladder 2 .
- liquid 18 is contained within a space formed between the inner plug 3 and outer stopper/bladder 2 .
- the outer stopper/bladder 2 expands like a balloon and applies a uniform pressure on the liquid 18 within this space 2 .
- the shape of the outer stopper/bladder 2 when filled can be spherical or cylindrical. Cylindrical shapes allow for the same stresses as presented in a spherical shape but with more volume.
- the outer stopper/bladder 2 is configured with a ring 6 to provide a seal against the inside of the vial 1 .
- the inner plug 3 and outer stopper/bladder 2 are configured to fit together to provide multiple seals between the inner plug 3 and outer stopper/bladder 2 .
- Seals 17 may be configured in a tongue-and-groove or other interlocking system to provide a sealing function. Alternatively or additionally, a seal 17 is provided by the compression of the crimp cap 4 on the inner plug 3 and outer stopper/bladder 2 against the vial 1 . Alternatively or additionally, a seal may be formed by the interference between the inner plug 3 and outer stopper/bladder 2 .
- the syringe 26 and vial adapter 28 are removed. This would be considered filling under liquid pressure.
- a vacuum could be formed in the space between the outer stopper/bladder 2 and inside of the vial 1 causing the expansion of the outer stopper/bladder 2 to prepare it for receiving liquid. This would be considered filling under no liquid pressure.
- the injector assembly 6 for injecting the contents of the vial assembly 5 described earlier preferably, but not exclusively, includes a vial holder 7 , needle hub 8 , needle 25 , adhesive 9 , outer housing 10 , safety pin 11 , double-sided tape 12 , bandage 13 and outer bandage cover 14 . Additionally, the injector assembly 6 could have the vent needle 15 .
- the vial holder 7 allows for containment of the vial assembly 5 and interfaces with the needle hub 8 , outer housing 10 and safety pin 11 . There are cutouts 19 in the side of the vial holder 7 to allow for viewing of the vial assembly 5 . Alternatively, the vial holder 7 may have transparent viewing windows.
- the needle 25 pierces the bandage 13 during activation of the injector assembly 6 prior to dispense of the liquid.
- the needle 25 inner diameter and length combined with the performance characteristics of the vial assembly 5 allow for control of the flow rate of the liquid during dispense.
- the adhesive 9 is used to bond the needle 25 to the needle hub 8 .
- This adhesive 9 could be for example, epoxy or cyanoacrylate and be air, moisture or UV cured.
- the outer housing 10 interfaces with the vial holder 7 , needle hub 8 , safety pin 11 and double-sided tape 12 . It provides the means to locate the injector assembly 6 onto the skin surface.
- the safety pin 11 prevents inadvertent advancement of the vial holder 7 relative to the outer housing 10 prior to intended use of the injector assembly 6 .
- the safety pin 11 interfaces with the outer housing 10 and vial holder 7 .
- the safety pin 11 can be configured to allow for radial and rotational movement relative to the outer housing 10 .
- the double-sided tape 12 allows for attachment of the outer housing 10 to the skin surface. It also holds the bandage 13 to the outer housing 10 until the outer housing 10 is removed from the skin surface. The bandage 13 allows for wound protection after the injector assembly 6 is removed from the skin surface.
- the bandage 13 interfaces with the outer housing 10 , double-sided tape 12 and the outer bandage cover 14 .
- the adhesion force between the bandage 13 and the skin surface is greater than the adhesion force between the bandage 13 and the double-sided tape 12 . This allows for removal of the injector assembly 6 from the skin surface without removal of the bandage 13 .
- the double-sided tape 12 interfaces with the outer housing 10 , bandage 13 and outer bandage cover 14 .
- the outer bandage cover 14 provides for protection of the bandage 13 and double-sided tape 12 prior to use of the injector assembly 6 .
- the outer bandage cover 14 is removed prior to use of the injector assembly 6 and interfaces with the double-sided tape 12 and bandage 13 .
- the vial assembly 5 is inserted into the injector assembly 6 until snaps 24 in the vial holder 7 interface with the crimp cap 4 on the vial assembly 5 to prevent it from being removed.
- the top of the vial assembly 5 may be flush with the top of the vial holder 7 allowing for one method of verification that the vial assembly 5 is sufficiently inserted into the injector assembly 6 .
- the vial holder 7 or vial assembly 5 cannot advance relative to the outer housing 10 as the safety pin 11 keeps them from advancing. Cutouts 19 in the vial holder 7 allow the user to view the inside of the vial assembly 5 .
- the outer bandage cover 14 is removed from the bottom of the injector assembly G. It is ready to be attached to the skin surface 16 .
- the injector assembly 6 can be attached to the skin surface 16 .
- the double-sided tape 12 will provide the adhesion force between the outer housing 10 and the skin surface 16 .
- the safety pin 11 is removed from the injector assembly 6 and it is ready for actuation.
- Detent features 21 in the vial holder 7 and outer housing 10 prevent the vial holder 7 from moving relative to the outer housing 10 without user intervention.
- the user pushes down on the vial holder 7 to begin inserting the needle 25 into the skin surface 16 .
- Ramp features (over-center mechanism) 22 in the vial holder 7 and outer housing 10 allow for relatively small applied force by the user to produce a relatively large axial movement of the vial holder 7 into the outer housing 10 .
- the needle 25 enters the liquid space within a cutout 19 in the inner plug 3 . This small amount of motion also allows the vent needle 15 to pierce the wall of the outer stopper/bladder 2 to allow for venting of the space between the outer stopper/bladder 2 and the inside of the vial 1 .
- substantially all of the liquid (preferably more than 95% and more preferably 99%) within the outer stopper/bladder 2 is dispensed into the user. Cutouts 19 in the vial holder 7 allow the user to visually confirm the entire amount of liquid was dispensed.
- the dispense is completed and the user begins to remove the injector assembly 6 by pulling up on the vial holder 7 .
- the adhesion force between the double-sided tape 12 and the skin surface 16 holds the outer housing 10 to the skin surface 16 .
- Axial movement of the vial holder 7 , vial assembly 5 , needle hub 8 and needle 25 continues relative to the outer housing 10 until the needle 25 is completely retracted into the outer housing 10 , shielding it from the user.
- the needle 25 may be deflected to a stored position that prevents reuse and protects against accidental needle stick by the user.
- snaps 20 in the outer housing 10 interface with the needle 25 and needle hub 8 to move it off center, slightly bending it and locking it out from being actuated again while also providing for additional needle shielding from the user.
- the injector assembly 6 is pulled away from the skin surface 16 .
- the bandage 13 peels away from the outer housing 10 and is left behind on the skin surface 16 .
- the vial holder and outer housing are preferably one piece, with an upper vial holder and lower base for contacting the skin of the patient. These upper and lower housing portions are hinged along an annular junction along the outer perimeter of the outer housing.
- the needle hub 8 can be separate or configured as part of the vial holder/outer housing 17 .
- the vial assembly 5 is inserted into the injector assembly 6 until snaps 17 in the vial holder/outer housing 7 interface with the crimp cap 4 on the vial assembly 5 to prevent it from being removed.
- the vial access end of the needle 3 is in communication with the liquid (drug, antibiotic or other medicament) 18 when the vial assembly 5 is inserted into the injector assembly 6 .
- the injection end of the needle 3 is embedded in an elastomeric needle shield 10 which prevents liquid 9 from coming out of the needle 3 .
- the vial assembly 5 cannot advance relative to the vial holder/outer housing 7 as the safety pin 11 keeps them from advancing.
- the injector assembly 6 is also covered with an outer bandage cover 14 .
- the outer bandage cover 14 and safety pin 11 is removed from the injector assembly 6 and it is ready for actuation.
- the injector assembly 6 can be attached to the skin surface 16 .
- the double-sided tape 12 will provide the adhesion force between the contact surface 15 of the vial holder/outer housing 7 and the skin surface 16 .
- the skin-facing surface of the housing includes a skin-facing protrusion 41 .
- the contact surface 15 of vial holder/outer housing 7 is designed to flex into the injector assembly 6 , providing for an over-center action to produce a relatively large axial movement of the contact surface 15 into the holder/outer housing 7 .
- Axial movement of the contact surface 15 of vial holder/outer housing 7 relative to the vial assembly 5 , needle hub 8 and needle 3 continues until the needle hub 8 bottoms out on the vial holder/outer housing 7 .
- the needle 3 passes through the needle shield 10 allowing for flow of the liquid 9 out of the needle 3 into the skin surface 16 . Additionally, this axial movement allows for complete needle travel into the skin surface 16 .
- substantially all of the liquid 9 (preferably more than 95% and more preferably 99%) within the outer stopper/bladder 2 is dispensed into the user.
- the dispense is completed and the user begins to remove the injector assembly 6 by pulling up on the vial holder/outer housing 7 .
- the adhesion force between the double-sided tape 12 attached to the contact surface 15 of the vial holder/outer housing 7 and the skin surface 16 causes the contact surface 15 to flex back to its original starting position. This provides for an over-center action to produce a relatively large axial movement of the contact surface 15 out of the vial holder/outer housing 7 .
- Axial movement of the contact surface 15 allows for axial movement of the vial holder/outer housing 7 , vial assembly 5 , needle hub 8 and needle 3 until the needle 3 is completely retracted into the vial holder/outer housing 7 , embedding the needle 3 back into the needle shield 10 , shielding it from the user.
- the bandage 13 peels away from the vial holder/outer housing 7 and is left behind on the skin surface 16 .
- the vial holder 7 and the outer housing 10 are joined by a flexible hinge 17 .
- the injector assembly 6 as seen in FIG. 25 , has three relatively movable that can pivot relative to one another including a vial holder 7 , a needle hub 8 , needle 21 and the outer housing 10 .
- the vial assembly 5 is inserted into the injector assembly 6 until snaps 20 in the vial holder 7 interface with the crimp cap 4 on the vial assembly 5 to prevent it from being removed.
- the vial holder 7 cannot advance relative to the outer housing 10 as the safety pin 11 keeps it from advancing.
- the bottom of the outer housing 10 is covered with an outer bandage cover 14 .
- the outer bandage cover 14 is removed from the bottom or base of the injector assembly 6 . It is ready to be attached to the skin surface 16 .
- the double-sided tape 12 will provide the adhesion force between the outer housing 10 and the skin surface 16 .
- the safety pin 11 is removed from the injector assembly 6 and it is ready for actuation.
- the user pushes down on the vial holder 7 to begin inserting the needle 21 into the skin surface 16 . Slight rotational movement of the vial holder 7 , vial assembly 5 , needle hub 8 and needle 21 (in unison) about the flexible hinge 17 continues until the needle hub 8 bottoms out on the outer housing 10 .
- An additional small movement allows the needle 21 to pierce the solid section of the inner plug 3 allowing communication of the needle 21 with the liquid 9 in the outer stopper/bladder 2 .
- the needle 21 enters the liquid space within a cutout 19 in the inner plug 3 .
- This small amount of motion also allows the vent needle 15 to pierce the wall of the outer stopper/bladder 2 to allow for venting of the space between the outer stopper/bladder 2 and the inside of the vial 1 .
- substantially all of the liquid (preferably more than 95% and more preferably 99%) within the outer stopper/bladder 2 is dispensed into the user.
- the dispense is completed and the user begins to remove the injector assembly 6 by pulling up on the vial holder 7 .
- the adhesion force between the double-sided tape 12 and the skin surface 16 holds the outer housing 10 to the skin surface 16 .
- Rotational movement about the flexible hinge 17 of the vial holder 7 , vial assembly 5 , needle hub 8 and needle 21 continues relative to the outer housing 10 until the needle 21 is completely retracted into the outer housing 10 , shielding it from the user.
- the injector assembly 6 is pulled away from the skin surface 16 .
- the bandage 13 peels away from the outer housing 10 and is left behind on the skin surface 16 .
- a filling apparatus 29 such as a filling needle, vial adapter spike or other means of filling may be used to introduce liquid 18 into the outer stopper/bladder 2 of the vial assembly 5 .
- a filling apparatus 29 may have one or more slots 30 integral to its body 32 , and communicating with an internal fill path that extends to a fill inlet that may be a luer port or other inlet.
- one and preferably two or more inner seals 31 may be configured into the inner stopper or plug 3 to interface with the body or shaft 32 of the filling apparatus 29 during filling and subsequent removal of the body 32 of the filling apparatus 29 .
- multiple inner seals 31 may be configured with an axial spacing to cover the slot 30 of the body 32 of the filling apparatus 29 to prevent loss of internal pressure or liquid 18 within the outer stopper/bladder 2 during the filling process.
- multiple inner seals 31 may be configured with an axial spacing to prevent communication between the internal space of the outer stopper/bladder 2 and the ambient environment resulting in loss of pressure or liquid 18 through the slot 30 of the body 32 of the filling apparatus 29 during retraction after filling.
- the tip 33 of the filling apparatus 29 is shown fully inserted into the inner plug 3 .
- the filling apparatus 29 is in communication with the outer stopper/bladder 2 and the inner seals 31 prevent loss of internal pressure or liquid 18 within the outer stopper/bladder 2 for sealing the pressure in the bladder as the fill apparatus or spike is retracted out of the filled pressurized bladder volume while maintaining a seal between the spike and ambient pressure.
- the distance or zone between two inner seals is greater than the length of slots 30 , whereby the fill apparatus or spike is sealed at at least one location, such as proximal to the slots or distal to the slots, as the spike is inserted or retracted.
- the filling apparatus 29 is partially withdrawn from the inner plug 3 of the vial assembly 5 .
- the filling apparatus 29 is in communication with the outer stopper/bladder 2 .
- the top of the slot 30 of the body 32 of the filling apparatus 29 is covered by the upper inner seal 31 to prevent loss of internal pressure or liquid 18 within the outer stopper/bladder 2 during withdraw of the filling apparatus.
- the filling apparatus 29 is further withdrawn from the inner plug 3 of the vial assembly 5 .
- the top of the slot 30 of the body 32 of the filling apparatus 29 is exposed to the ambient environment but the tip 33 of the filling apparatus 29 is sealed by the lower inner seal 31 . This prevents communication between the filling apparatus 29 and outer stopper/bladder 2 and thus prevents loss of internal pressure or liquid 18 within the outer stopper/bladder 2 during withdraw of the filling apparatus 29 .
- a vial with resilient inner bladder for containing a drug, antibiotic or other medical liquid injectable and a pre-stress member within the bladder;
- a vial subassembly comprising a resilient bladder and a pre-stress member within the bladder
- a slotted fill apparatus or spike in combination with plural internal vial seals that define a seal zone between the seals longer than the spike slots(s) to seal the bladder during insertion and withdrawal of the spike.
- (A) provide for injection of substantially all the vial contents, preferably at least 95% and more preferably at least 99%;
- (C) provide for sequential steps or stages in the injection assembly for advancing a vial from a loading configuration to an injection configuration
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Abstract
Description
- This application is a continuation of U.S. application Ser. No. 15/481,753, filed Apr. 7, 2017, which is a continuation of U.S. application Ser. No. 14/423,938, filed Feb. 25, 2015, which is the National Stage of International Application No. PCT/US2013/059359, filed Sep. 12, 2013, which claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/704,922, filed Sep. 24, 2012, the contents of each of which are hereby incorporated by reference herein.
- This disclosure relates generally to vials for medical liquids, such as drugs, antibiotics, or other liquids for medical therapeutic or diagnostic purposes, and to injection apparatus for injecting the vial contents. More specifically, this subject matter relates to such vials, which can be pre-filled with medical liquid and that can expel substantially all the contents, preferably at a generally constant flow rate, and to injection apparatus or assemblies for use with such vials and to methods of filling and using such vials and apparatus.
- The description below is directed to specific exemplary embodiments for the purposes of illustration and not limitation. The features described herein may be employed in other configurations or designs without departing from the scope of this disclosure. PCT International Publication No. WO 2011/123569 A1 is hereby incorporated by reference herein.
-
FIG. 1 is a cross-sectional view of a preferred embodiment of the present invention. In this view, the vial assembly is shown in the unfilled state. -
FIG. 2 is a cross-sectional view of a preferred embodiment of the present invention. In this view, the vial assembly is shown in the filled state. -
FIGS. 3-4 are cross-sectional views of the vial assembly being filled with a syringe and vial adapter. The vial assembly is shown in the unfilled state inFIG. 3 and shown in the filled state inFIG. 4 . -
FIG. 5 is a perspective view of the preferred embodiment of the present invention. In this view the filled vial assembly is being inserted into the injector assembly. -
FIG. 6 is cross-sectional view ofFIG. 5 . -
FIGS. 7-14 are cross-sectional views of the preferred embodiment of the present invention of the injector assembly with vial assembly in place showing different sequences during the injection. -
FIG. 15 is a perspective view of the preferred embodiment of the present invention of the injector assembly being removed from the injection surface after delivery of the liquid. -
FIG. 16 is a perspective view of an alternative embodiment. In this view the filled vial assembly is being inserted into the injector assembly. -
FIG. 17 is cross-sectional view ofFIG. 16 . -
FIGS. 18-22 are cross-sectional views of an alternative embodiment of the injector assembly with vial assembly in place showing different sequences during the injection. -
FIG. 23 is a perspective view of an alternative embodiment of the injector assembly being removed from the injection surface after delivery of the liquid. -
FIG. 24 is a perspective view of an alternative embodiment of an injector assembly. In this view the filled vial assembly is being inserted into the injector assembly. -
FIG. 25 is cross-sectional view ofFIG. 24 . -
FIGS. 26-29 are cross-sectional views of an alternative embodiment of the injector assembly with vial assembly in place showing different sequences during the injection. -
FIG. 30 is a perspective view of an alternative embodiment of the injector assembly being removed from the injection surface (e.g. patient's skin) after delivery of the liquid. -
FIG. 31 is a perspective view of a vial such as inFIG. 1 and a filling apparatus or spike for introducing medical liquid into the vial. -
FIG. 32 is a cross-sectional perspective view of the vial ofFIG. 31 with filling apparatus fully inserted. -
FIG. 33 is a cross-sectional perspective view of the vial ofFIG. 32 , with the filling apparatus partially withdrawn or partially inserted. -
FIG. 34 is a cross-sectional perspective view of the vial ofFIG. 33 , with the filling apparatus further withdrawn or less inserted. - Referring to
FIG. 1 , thevial assembly 5 may include a vial 1, outer stopper/bladder 2,inner plug 3 andcrimp cap 4. The vial 1 may be constructed from glass or plastic and range in volume from 1 mL to 10 mL. Thecrimp cap 4 can be constructed from plastic, aluminum or steel and may include an optional pop-off safety tab. Thecrimp cap 4 could fit a range of vial neck sizes from 13 to 32 mm in diameter. The outer stopper/bladder 2 (also known as the outer expanding element or balloon) andinner plug 3 can be made from blended synthetic rubber. They may also be independently different materials. This could include one or more of the following in different concentrations: bromobutyl, chlorobutyl, isoprene, polyisoprene, SBR, polybudtadiene, EPDM, natural rubber and silicone. In addition, these rubber components can be coated to improve their surface properties. Coatings may include parylene, silicone, teflon and flourine gas treatments. Alternatively, the outer stopper/bladder 2 andinner plug 3 may be made from a thermoplastic elastomer. The outer stopper/bladder 2 may have irregular wall thickness both in the axial and circumferential direction including ribs or grooves to provide intended variations in stress as a function of strain. This would allow for control over the pressure profile to control the delivery flow rate as a function of diameter extension. - The assembly of the vial 1 may include a sub-assembly of the
inner plug 3 and outer stopper/bladder 2 prior to insertion into the vial 1. Alternatively, the outer stopper/bladder 2 can be assembled into the vial 1 and then theinner plug 3 assembled into the outer stopper/bladder 2. Once the outer stopper/bladder 2 andinner plug 3 assembly are placed into the vial 1, thecrimp cap 4 is placed onto the vial 1. The crimp force applied by thecrimp cap 4 can be varied to achieve different compression forces on the outer stopper/bladder 2 andinner plug 3 assembly. This may allow for control of the seal performance or venting function. Theinner plug 3 is configured or sized to provide a pre-stress on the outer stopper/bladder 2 to control the pressure profile as well as to aid in delivery of all or substantially all of the liquid contained within the outer stopper/bladder 2, preferably at about a constant flow rate for most of the injection. A pre-stress between theinner plug 3 and outer stopper/bladder 2 can be created by making the outer diameter of theinner plug 3 larger than inner diameter of the outer stopper/bladder 2. Theinner plug 3 could be a solid piece of material or could be expandable element to control the amount of pre-stress. Gas or liquid could be introduced into a void formed within theinner plug 3 to change its outer diameter or length thus causing varying amounts of pre-stress. Alternatively or additionally, pre-stress can be created by making theinner plug 3 longer than the outer stopper/bladder 2. - Referring to
FIG. 2 ,liquid 18 is contained within a space formed between theinner plug 3 and outer stopper/bladder 2. The outer stopper/bladder 2 expands like a balloon and applies a uniform pressure on theliquid 18 within thisspace 2. The shape of the outer stopper/bladder 2 when filled can be spherical or cylindrical. Cylindrical shapes allow for the same stresses as presented in a spherical shape but with more volume. When thevial assembly 5 is coupled with an injector assembly, the pressure exerted by the outer stopper/bladder 2 on the liquid 18 allows for flow of the liquid 18 out of thevial assembly 5 through the needle of the injector assembly into the patient. The outer stopper/bladder 2 is configured with aring 6 to provide a seal against the inside of the vial 1. Theinner plug 3 and outer stopper/bladder 2 are configured to fit together to provide multiple seals between theinner plug 3 and outer stopper/bladder 2.Seals 17 may be configured in a tongue-and-groove or other interlocking system to provide a sealing function. Alternatively or additionally, aseal 17 is provided by the compression of thecrimp cap 4 on theinner plug 3 and outer stopper/bladder 2 against the vial 1. Alternatively or additionally, a seal may be formed by the interference between theinner plug 3 and outer stopper/bladder 2. - Referring to
FIGS. 3 and 4 , filling of thevial assembly 5 withliquid 18 can be performed by the user or by filling equipment. A user filled system may include thevial assembly 5 connected to avial adapter 28 andsyringe 26. Thesyringe 26 andvial adapter 28 is assembled to anempty vial assembly 5. The spike on thevial adapter 28 pierces the solid rubber section of theinner plug 3. The liquid 18 is manually transferred to thevial assembly 5 between the outer stopper/bladder 2 and theinner plug 3 by the user depressing the plunger 27 of thesyringe 26 causing the outer stopper/bladder 2 to inflate like a balloon. Once the liquid 18 is transferred to the outer stopper/bladder 2, thesyringe 26 andvial adapter 28 are removed. This would be considered filling under liquid pressure. Alternatively, a vacuum could be formed in the space between the outer stopper/bladder 2 and inside of the vial 1 causing the expansion of the outer stopper/bladder 2 to prepare it for receiving liquid. This would be considered filling under no liquid pressure. - Referring to
FIGS. 5 and 6 , theinjector assembly 6 for injecting the contents of thevial assembly 5 described earlier preferably, but not exclusively, includes avial holder 7,needle hub 8,needle 25,adhesive 9,outer housing 10,safety pin 11, double-sided tape 12,bandage 13 andouter bandage cover 14. Additionally, theinjector assembly 6 could have thevent needle 15. Thevial holder 7 allows for containment of thevial assembly 5 and interfaces with theneedle hub 8,outer housing 10 andsafety pin 11. There arecutouts 19 in the side of thevial holder 7 to allow for viewing of thevial assembly 5. Alternatively, thevial holder 7 may have transparent viewing windows. This allows for viewing thevial assembly 5 to confirm the proper dose has been delivered. Theneedle hub 8 allows for containment of theneedle 25 and interfaces with thevial holder 7,adhesive 9 andinner plug 3. Theneedle hub 8 can move relative thevial holder 7 andinner plug 3 and allows for communication of theneedle 25 with the liquid 18 in the outer stopper/bladder 2 during dispense. Theneedle hub 8 may also have the ability for rotational movement to dislocate theneedle 25 during removal of theinjector assembly 6 for needle stick safety. Theneedle 25 interfaces with the adhesive 9,needle hub 8,bandage 13 andinner plug 3. Theneedle 25 pierces the solid rubber portion of theinner plug 3 to allow for communication of the liquid 18 contained within the outer stopper/bladder 2 during dispense. Theneedle 25 pierces thebandage 13 during activation of theinjector assembly 6 prior to dispense of the liquid. Theneedle 25 inner diameter and length combined with the performance characteristics of thevial assembly 5 allow for control of the flow rate of the liquid during dispense. The adhesive 9 is used to bond theneedle 25 to theneedle hub 8. This adhesive 9 could be for example, epoxy or cyanoacrylate and be air, moisture or UV cured. - The
outer housing 10 interfaces with thevial holder 7,needle hub 8,safety pin 11 and double-sided tape 12. It provides the means to locate theinjector assembly 6 onto the skin surface. Thesafety pin 11 prevents inadvertent advancement of thevial holder 7 relative to theouter housing 10 prior to intended use of theinjector assembly 6. Thesafety pin 11 interfaces with theouter housing 10 andvial holder 7. Thesafety pin 11 can be configured to allow for radial and rotational movement relative to theouter housing 10. The double-sided tape 12 allows for attachment of theouter housing 10 to the skin surface. It also holds thebandage 13 to theouter housing 10 until theouter housing 10 is removed from the skin surface. Thebandage 13 allows for wound protection after theinjector assembly 6 is removed from the skin surface. Thebandage 13 interfaces with theouter housing 10, double-sided tape 12 and theouter bandage cover 14. The adhesion force between thebandage 13 and the skin surface is greater than the adhesion force between thebandage 13 and the double-sided tape 12. This allows for removal of theinjector assembly 6 from the skin surface without removal of thebandage 13. The double-sided tape 12 interfaces with theouter housing 10,bandage 13 andouter bandage cover 14. Theouter bandage cover 14 provides for protection of thebandage 13 and double-sided tape 12 prior to use of theinjector assembly 6. Theouter bandage cover 14 is removed prior to use of theinjector assembly 6 and interfaces with the double-sided tape 12 andbandage 13. - Referring to
FIGS. 7-9 , thevial assembly 5 is inserted into theinjector assembly 6 untilsnaps 24 in thevial holder 7 interface with thecrimp cap 4 on thevial assembly 5 to prevent it from being removed. The top of thevial assembly 5 may be flush with the top of thevial holder 7 allowing for one method of verification that thevial assembly 5 is sufficiently inserted into theinjector assembly 6. Thevial holder 7 orvial assembly 5 cannot advance relative to theouter housing 10 as thesafety pin 11 keeps them from advancing.Cutouts 19 in thevial holder 7 allow the user to view the inside of thevial assembly 5. InFIG. 8 , theouter bandage cover 14 is removed from the bottom of the injector assembly G. It is ready to be attached to theskin surface 16. InFIG. 9 , theinjector assembly 6 can be attached to theskin surface 16. The double-sided tape 12 will provide the adhesion force between theouter housing 10 and theskin surface 16. - Referring to
FIGS. 10-12 , once theinjector assembly 6 is place on theskin surface 16, thesafety pin 11 is removed from theinjector assembly 6 and it is ready for actuation. Detent features 21 in thevial holder 7 andouter housing 10 prevent thevial holder 7 from moving relative to theouter housing 10 without user intervention. InFIG. 11 , the user pushes down on thevial holder 7 to begin inserting theneedle 25 into theskin surface 16. Ramp features (over-center mechanism) 22 in thevial holder 7 andouter housing 10 allow for relatively small applied force by the user to produce a relatively large axial movement of thevial holder 7 into theouter housing 10. Axial movement of thevial holder 7,vial assembly 5,needle hub 8 and needle 25 (in unison) continues until theneedle hub 8 bottoms out on theouter housing 10. InFIG. 12 , theneedle 25 andneedle hub 8 motion stop relative to theouter housing 10 just before theneedle 25 is in communication with the fluid in the outer stopper/bladder 2. While a latch/lockout 23 releases thevial holder 7 for an additional small movement to allow theneedle 25 to pierce the solid section of theinner plug 3 and allowing communication of theneedle 25 with the liquid in the outer stopper/bladder 2. The latch/lockout 23 allows forcomplete needle 25 travel into theskin surface 16 before the start of dispense. Theneedle 25 enters the liquid space within acutout 19 in theinner plug 3. This small amount of motion also allows thevent needle 15 to pierce the wall of the outer stopper/bladder 2 to allow for venting of the space between the outer stopper/bladder 2 and the inside of the vial 1. - Referring to
FIGS. 13-15 , once theneedle 25 is in communication with the liquid, substantially all of the liquid (preferably more than 95% and more preferably 99%) within the outer stopper/bladder 2 is dispensed into the user.Cutouts 19 in thevial holder 7 allow the user to visually confirm the entire amount of liquid was dispensed. InFIG. 14 , the dispense is completed and the user begins to remove theinjector assembly 6 by pulling up on thevial holder 7. The adhesion force between the double-sided tape 12 and theskin surface 16 holds theouter housing 10 to theskin surface 16. Axial movement of thevial holder 7,vial assembly 5,needle hub 8 and needle 25 (in unison) continues relative to theouter housing 10 until theneedle 25 is completely retracted into theouter housing 10, shielding it from the user. Once inside theouter housing 10, theneedle 25 may be deflected to a stored position that prevents reuse and protects against accidental needle stick by the user. For example, snaps 20 in theouter housing 10 interface with theneedle 25 andneedle hub 8 to move it off center, slightly bending it and locking it out from being actuated again while also providing for additional needle shielding from the user. At the end of thevial holder 7 travel within theouter housing 10, theinjector assembly 6 is pulled away from theskin surface 16. Thebandage 13 peels away from theouter housing 10 and is left behind on theskin surface 16. - Referring to
FIGS. 16-17 , in this embodiment, the vial holder and outer housing are preferably one piece, with an upper vial holder and lower base for contacting the skin of the patient. These upper and lower housing portions are hinged along an annular junction along the outer perimeter of the outer housing. Theneedle hub 8 can be separate or configured as part of the vial holder/outer housing 17. Thevial assembly 5 is inserted into theinjector assembly 6 untilsnaps 17 in the vial holder/outer housing 7 interface with thecrimp cap 4 on thevial assembly 5 to prevent it from being removed. In this embodiment, the vial access end of theneedle 3 is in communication with the liquid (drug, antibiotic or other medicament) 18 when thevial assembly 5 is inserted into theinjector assembly 6, The injection end of theneedle 3 is embedded in anelastomeric needle shield 10 which prevents liquid 9 from coming out of theneedle 3. Thevial assembly 5 cannot advance relative to the vial holder/outer housing 7 as thesafety pin 11 keeps them from advancing. Theinjector assembly 6 is also covered with anouter bandage cover 14. - Referring to
FIGS. 18-19 , theouter bandage cover 14 andsafety pin 11 is removed from theinjector assembly 6 and it is ready for actuation. InFIG. 19 , theinjector assembly 6 can be attached to theskin surface 16. The double-sided tape 12 will provide the adhesion force between thecontact surface 15 of the vial holder/outer housing 7 and theskin surface 16. As illustrated inFIG. 19 , the skin-facing surface of the housing includes a skin-facingprotrusion 41. - Referring to
FIGS. 20-21 , when the user attaches theinjector assembly 6 to theskin surface 16, thecontact surface 15 of vial holder/outer housing 7 is designed to flex into theinjector assembly 6, providing for an over-center action to produce a relatively large axial movement of thecontact surface 15 into the holder/outer housing 7. Axial movement of thecontact surface 15 of vial holder/outer housing 7 relative to thevial assembly 5,needle hub 8 andneedle 3 continues until theneedle hub 8 bottoms out on the vial holder/outer housing 7. Additionally, theneedle 3 passes through theneedle shield 10 allowing for flow of the liquid 9 out of theneedle 3 into theskin surface 16. Additionally, this axial movement allows for complete needle travel into theskin surface 16. InFIG. 21 , substantially all of the liquid 9 (preferably more than 95% and more preferably 99%) within the outer stopper/bladder 2 is dispensed into the user. - Referring to
FIGS. 22-23 , the dispense is completed and the user begins to remove theinjector assembly 6 by pulling up on the vial holder/outer housing 7. The adhesion force between the double-sided tape 12 attached to thecontact surface 15 of the vial holder/outer housing 7 and theskin surface 16 causes thecontact surface 15 to flex back to its original starting position. This provides for an over-center action to produce a relatively large axial movement of thecontact surface 15 out of the vial holder/outer housing 7. Axial movement of thecontact surface 15 allows for axial movement of the vial holder/outer housing 7,vial assembly 5,needle hub 8 andneedle 3 until theneedle 3 is completely retracted into the vial holder/outer housing 7, embedding theneedle 3 back into theneedle shield 10, shielding it from the user. When theinjector assembly 6 is pulled away from theskin surface 16, thebandage 13 peels away from the vial holder/outer housing 7 and is left behind on theskin surface 16. - Referring to
FIGS. 24-25 , in this embodiment, thevial holder 7 and theouter housing 10 are joined by aflexible hinge 17. Theinjector assembly 6, as seen inFIG. 25 , has three relatively movable that can pivot relative to one another including avial holder 7, aneedle hub 8,needle 21 and theouter housing 10. Thevial assembly 5 is inserted into theinjector assembly 6 untilsnaps 20 in thevial holder 7 interface with thecrimp cap 4 on thevial assembly 5 to prevent it from being removed. Thevial holder 7 cannot advance relative to theouter housing 10 as thesafety pin 11 keeps it from advancing. The bottom of theouter housing 10 is covered with anouter bandage cover 14. - Referring to
FIGS. 26-27 , theouter bandage cover 14 is removed from the bottom or base of theinjector assembly 6. It is ready to be attached to theskin surface 16. The double-sided tape 12 will provide the adhesion force between theouter housing 10 and theskin surface 16. Once theinjector assembly 6 is placed on theskin surface 16, thesafety pin 11 is removed from theinjector assembly 6 and it is ready for actuation. InFIG. 26 , the user pushes down on thevial holder 7 to begin inserting theneedle 21 into theskin surface 16. Slight rotational movement of thevial holder 7,vial assembly 5,needle hub 8 and needle 21 (in unison) about theflexible hinge 17 continues until theneedle hub 8 bottoms out on theouter housing 10. InFIG. 27 , theneedle 21 andneedle hub 8 motion stop relative to theouter housing 10 just before theneedle 21 is in communication with the fluid in the outer stopper/bladder 2. An additional small movement allows theneedle 21 to pierce the solid section of theinner plug 3 allowing communication of theneedle 21 with the liquid 9 in the outer stopper/bladder 2. This allows forcomplete needle 21 travel into theskin surface 16 before the start of dispense. Theneedle 21 enters the liquid space within acutout 19 in theinner plug 3. This small amount of motion also allows thevent needle 15 to pierce the wall of the outer stopper/bladder 2 to allow for venting of the space between the outer stopper/bladder 2 and the inside of the vial 1. - Referring to
FIGS. 28-29 , once theneedle 21 is in communication with the liquid, substantially all of the liquid (preferably more than 95% and more preferably 99%) within the outer stopper/bladder 2 is dispensed into the user. InFIG. 29 , the dispense is completed and the user begins to remove theinjector assembly 6 by pulling up on thevial holder 7. The adhesion force between the double-sided tape 12 and theskin surface 16 holds theouter housing 10 to theskin surface 16. Rotational movement about theflexible hinge 17 of thevial holder 7,vial assembly 5,needle hub 8 and needle 21 (in unison) continues relative to theouter housing 10 until theneedle 21 is completely retracted into theouter housing 10, shielding it from the user. - Referring to
FIG. 30 , at the end of thevial holder 7 travel relative theouter housing 10, theinjector assembly 6 is pulled away from theskin surface 16. Thebandage 13 peels away from theouter housing 10 and is left behind on theskin surface 16. - Referring to
FIGS. 31-32 , a fillingapparatus 29 such as a filling needle, vial adapter spike or other means of filling may be used to introduce liquid 18 into the outer stopper/bladder 2 of thevial assembly 5. A fillingapparatus 29 may have one ormore slots 30 integral to itsbody 32, and communicating with an internal fill path that extends to a fill inlet that may be a luer port or other inlet. To allow for filling of the outer stopper/bladder 2 of thevial assembly 5 using a fillingapparatus 29, one and preferably two or moreinner seals 31 may be configured into the inner stopper or plug 3 to interface with the body orshaft 32 of the fillingapparatus 29 during filling and subsequent removal of thebody 32 of the fillingapparatus 29. Alternatively or additionally, multipleinner seals 31 may be configured with an axial spacing to cover theslot 30 of thebody 32 of the fillingapparatus 29 to prevent loss of internal pressure or liquid 18 within the outer stopper/bladder 2 during the filling process. Alternatively or additionally, multipleinner seals 31 may be configured with an axial spacing to prevent communication between the internal space of the outer stopper/bladder 2 and the ambient environment resulting in loss of pressure or liquid 18 through theslot 30 of thebody 32 of the fillingapparatus 29 during retraction after filling. InFIG. 32 , thetip 33 of the fillingapparatus 29 is shown fully inserted into theinner plug 3. The fillingapparatus 29 is in communication with the outer stopper/bladder 2 and theinner seals 31 prevent loss of internal pressure or liquid 18 within the outer stopper/bladder 2 for sealing the pressure in the bladder as the fill apparatus or spike is retracted out of the filled pressurized bladder volume while maintaining a seal between the spike and ambient pressure. Specifically, the distance or zone between two inner seals is greater than the length ofslots 30, whereby the fill apparatus or spike is sealed at at least one location, such as proximal to the slots or distal to the slots, as the spike is inserted or retracted. - Referring to
FIGS. 33-34 , the fillingapparatus 29 is partially withdrawn from theinner plug 3 of thevial assembly 5. The fillingapparatus 29 is in communication with the outer stopper/bladder 2. The top of theslot 30 of thebody 32 of the fillingapparatus 29 is covered by the upperinner seal 31 to prevent loss of internal pressure or liquid 18 within the outer stopper/bladder 2 during withdraw of the filling apparatus. InFIG. 34 , the fillingapparatus 29 is further withdrawn from theinner plug 3 of thevial assembly 5. The top of theslot 30 of thebody 32 of the fillingapparatus 29 is exposed to the ambient environment but thetip 33 of the fillingapparatus 29 is sealed by the lowerinner seal 31. This prevents communication between the fillingapparatus 29 and outer stopper/bladder 2 and thus prevents loss of internal pressure or liquid 18 within the outer stopper/bladder 2 during withdraw of the fillingapparatus 29. - The foregoing description contains numerous independent concepts, features and functions that have utility and may be claimed separately and in combination with other concepts, features or functions, including, without limitation:
- (1) a vial with resilient inner bladder for containing a drug, antibiotic or other medical liquid injectable and a pre-stress member within the bladder;
- (2) a method of making, filling and using such a vial;
- (3) a vial injection assembly for injecting the contents of such a pre-filled vial into a patient;
- (4) the combination of such a vial injection assembly and pre-filled vial; and
- (5) a method of injecting the contents of a pre-filled vial through the skin of a patient;
- (6) a vial subassembly comprising a resilient bladder and a pre-stress member within the bladder; and
- (7) a slotted fill apparatus or spike in combination with plural internal vial seals that define a seal zone between the seals longer than the spike slots(s) to seal the bladder during insertion and withdrawal of the spike.
- The foregoing concepts are useful and may be claimed alone or with one or more of the other above concepts and/or with other features or functions described herein, including, without limitation, features and/or functions that:
- (A) provide for injection of substantially all the vial contents, preferably at least 95% and more preferably at least 99%;
- (B) provide for injection of most of the vial contents at substantially constant flow rates;
- (C) provide for sequential steps or stages in the injection assembly for advancing a vial from a loading configuration to an injection configuration;
- (D) protect an injection needle against inadvertent needle sticks;
- (E) prevent reuse of the injection assembly;
- (F) automatically provide a bandage at the site of the injection;
- (G) provide an injection without substantial user discomfort;
- (H) vent displacement air into a vial between a pre-filled bladder and vial housing during injection;
- (I) retain the injection assembly on the skin of a patient until removed by the user;
- (J) permit filling of an internal vial bladder either manually or by large scale filling equipment;
- (K) allow pre-stress of the vial bladder to be changed by changing the size or configuration of a pre-stress member located within the bladder; and/or
- (L) provide any combination of the above concepts and/or features or functions.
Claims (5)
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US16/923,612 US20200338257A1 (en) | 2012-09-24 | 2020-07-08 | Medical vial and injector assemblies and methods of use |
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US201261704922P | 2012-09-24 | 2012-09-24 | |
PCT/US2013/059359 WO2014046950A1 (en) | 2012-09-24 | 2013-09-12 | Medication vial and injector assemblies and methods of use |
US201514423938A | 2015-02-25 | 2015-02-25 | |
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US16/923,612 US20200338257A1 (en) | 2012-09-24 | 2020-07-08 | Medical vial and injector assemblies and methods of use |
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US14/423,938 Abandoned US20150217058A1 (en) | 2012-09-24 | 2013-09-12 | Medical vial and injector assemblies and methods of use |
US15/481,753 Active 2033-12-23 US10729842B2 (en) | 2012-09-24 | 2017-04-07 | Medical vial and injector assemblies and methods of use |
US16/923,612 Pending US20200338257A1 (en) | 2012-09-24 | 2020-07-08 | Medical vial and injector assemblies and methods of use |
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US15/481,753 Active 2033-12-23 US10729842B2 (en) | 2012-09-24 | 2017-04-07 | Medical vial and injector assemblies and methods of use |
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---|---|---|---|---|
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US11317944B2 (en) | 2011-03-14 | 2022-05-03 | Unomedical A/S | Inserter system with transport protection |
US11357912B2 (en) | 2016-01-19 | 2022-06-14 | Unomedical A/S | Cannula and infusion devices |
US11458292B2 (en) | 2019-05-20 | 2022-10-04 | Unomedical A/S | Rotatable infusion device and methods thereof |
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US11771841B2 (en) | 2020-12-23 | 2023-10-03 | Tolmar International Limited | Systems and methods for mixing syringe valve assemblies |
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Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2016235054B2 (en) | 2015-03-24 | 2020-07-16 | Kaleo, Inc. | Devices and methods for delivering a lyophilized medicament |
JP6830067B2 (en) | 2015-06-30 | 2021-02-17 | カレオ,インコーポレイテッド | Automatic syringe that administers medication in a prefilled syringe |
WO2018119218A1 (en) | 2016-12-23 | 2018-06-28 | Kaleo, Inc. | Medicament delivery device and methods for delivering drugs to infants and children |
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US11964121B2 (en) * | 2021-10-13 | 2024-04-23 | Satio, Inc. | Mono dose dermal patch for pharmaceutical delivery |
US12048543B2 (en) | 2021-11-08 | 2024-07-30 | Satio, Inc. | Dermal patch for collecting a physiological sample with removable vial |
US12023156B2 (en) | 2021-10-13 | 2024-07-02 | Satio, Inc. | Dermal patch for collecting a physiological sample |
US12053284B2 (en) | 2021-11-08 | 2024-08-06 | Satio, Inc. | Dermal patch for collecting a physiological sample |
WO2023034826A1 (en) * | 2021-08-31 | 2023-03-09 | Aktivax, Inc. | Packaging arrangement for a beneficial agent |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3094988A (en) * | 1961-09-18 | 1963-06-25 | Dunmire Hannah | Hypodermic ampoules |
US3797490A (en) * | 1971-02-11 | 1974-03-19 | Ampoules Inc | Hypodermic ampoule with skin tensioning clip |
US5527288A (en) * | 1990-12-13 | 1996-06-18 | Elan Medical Technologies Limited | Intradermal drug delivery device and method for intradermal delivery of drugs |
US20040116847A1 (en) * | 2002-09-12 | 2004-06-17 | Children's Hospital Medical Center | Method and device for painless injection of medication |
US20090054866A1 (en) * | 2005-01-24 | 2009-02-26 | Novo Nordisk A/S | Transcutaneous Device Assembly |
US20110092883A1 (en) * | 2009-10-16 | 2011-04-21 | Kenichi Uchiyama | Transdermal drug administration apparatus and transdermal drug administration unit |
US20130060233A1 (en) * | 2011-09-02 | 2013-03-07 | Unitract Syringe Pty Ltd | Insertion mechanism for a drug delivery pump |
US20130324884A1 (en) * | 2010-10-11 | 2013-12-05 | Paul Hadváry | Syringe type pump |
US20140236089A1 (en) * | 2011-09-23 | 2014-08-21 | Ambro B.V. | System for transporting fluid across or into a biological barrier, device and capsule as part of the system |
Family Cites Families (162)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2584397A (en) | 1945-10-03 | 1952-02-05 | Louis K Pitman | Apparatus for transferring liquid from one container to another |
US2737948A (en) | 1954-08-23 | 1956-03-13 | Pfizer & Co C | Disposable cartridge for hypodermic syringe |
US3016895A (en) | 1958-08-01 | 1962-01-16 | Pan American Lab Inc | Injector for subcutaneous implantation of solids |
US2941531A (en) | 1958-08-26 | 1960-06-21 | Roehr Products Company Inc | Hypodermic needle assembly |
US3089491A (en) | 1961-08-24 | 1963-05-14 | Mirow Nathan | Cartridge seal and needle holder with air-lock device |
NL296017A (en) | 1962-08-03 | 1900-01-01 | ||
US3608550A (en) | 1969-05-07 | 1971-09-28 | Becton Dickinson Co | Transfer needle assembly |
US3993069A (en) | 1973-03-26 | 1976-11-23 | Alza Corporation | Liquid delivery device bladder |
US4201207A (en) | 1973-03-26 | 1980-05-06 | Alza Corporation | Bladder for liquid dispenser |
US3941171A (en) | 1973-07-05 | 1976-03-02 | Ims Limited | Fluid transfer device |
US3938520A (en) | 1974-06-10 | 1976-02-17 | Abbott Laboratories | Transfer unit having a dual channel transfer member |
US4031889A (en) | 1975-03-25 | 1977-06-28 | William Floyd Pike | Power operated aspirating hypodermic syringe |
US4386929A (en) | 1980-01-18 | 1983-06-07 | Alza Corporation | Elastomeric bladder assembly |
US4337769A (en) | 1980-08-01 | 1982-07-06 | Baxter Travenol Laboratories, Inc. | Pressure infusion module |
US4387833A (en) | 1980-12-16 | 1983-06-14 | Container Industries, Inc. | Apparatus for containing and dispensing fluids under pressure and method of producing same |
US4525164A (en) | 1981-04-24 | 1985-06-25 | Biotek, Inc. | Wearable medication infusion system with arcuated reservoir |
US4419096A (en) | 1982-02-22 | 1983-12-06 | Alza Corporation | Elastomeric bladder assembly |
EP0126718A3 (en) | 1983-05-20 | 1985-10-23 | Bengt Gustavsson | A device for transferring a substance from one vessel to another and further to the intended application |
US4537593A (en) | 1983-06-06 | 1985-08-27 | Becton, Dickinson And Co. | Self-venting, non-coring needle assembly |
US4743243A (en) | 1984-01-03 | 1988-05-10 | Vaillancourt Vincent L | Needle with vent filter assembly |
US4583971A (en) | 1984-02-10 | 1986-04-22 | Travenol European Research And Development Centre (Teradec) | Closed drug delivery system |
US4543101A (en) | 1984-03-28 | 1985-09-24 | Adria Laboratories, Inc. | Valve device to aid in reconstituting injectable powders |
US4619651A (en) | 1984-04-16 | 1986-10-28 | Kopfer Rudolph J | Anti-aerosoling drug reconstitution device |
US4702397A (en) | 1984-09-18 | 1987-10-27 | Infusion Systems Corporation | Pressurized fluid dispenser |
DE3510166A1 (en) | 1985-03-21 | 1987-01-22 | Tecnotrans Ag | REFILL CAP FOR CHEMICAL-PHARMACEUTICAL SUBSTANCES AND METHOD FOR THE PRODUCTION THEREOF |
US5263935A (en) * | 1986-11-26 | 1993-11-23 | Baxter International Inc. | Pressurized fluid dispenser |
CA1283827C (en) | 1986-12-18 | 1991-05-07 | Giorgio Cirelli | Appliance for injection of liquid formulations |
US4734092A (en) | 1987-02-18 | 1988-03-29 | Ivac Corporation | Ambulatory drug delivery device |
US4886495A (en) | 1987-07-08 | 1989-12-12 | Duoject Medical Systems Inc. | Vial-based prefilled syringe system for one or two component medicaments |
US5411499A (en) | 1988-01-25 | 1995-05-02 | Baxter International Inc. | Needleless vial access device |
US4823623A (en) | 1988-04-06 | 1989-04-25 | Norton Company | Device for transfer of fluid into sealable vials |
US5011477A (en) | 1989-04-21 | 1991-04-30 | Baxter International Inc. | Continuous/bolus infusor |
US5205820A (en) | 1989-06-16 | 1993-04-27 | Science, Incorporated | Fluid delivery apparatus |
US5122116A (en) | 1990-04-24 | 1992-06-16 | Science Incorporated | Closed drug delivery system |
US5045064A (en) | 1990-06-01 | 1991-09-03 | Infusaid, Inc. | Constant pressure implantable pump reservoir |
US5360410A (en) | 1991-01-16 | 1994-11-01 | Senetek Plc | Safety syringe for mixing two-component medicaments |
US5709668A (en) | 1991-01-16 | 1998-01-20 | Senetek Plc | Automatic medicament injector employing non-coring needle |
US5298023A (en) | 1991-03-08 | 1994-03-29 | Habley Medical Technology Corporation | Multiple pharmaceutical dispenser with accumulator |
US5167641A (en) | 1991-05-29 | 1992-12-01 | Arnis, Inc. | Auto-retracting needle injector system |
US5298025A (en) | 1991-07-08 | 1994-03-29 | Baxter International Inc. | Sequential flow rate infusion rate |
US5329976A (en) | 1991-12-09 | 1994-07-19 | Habley Medical Technology Corporation | Syringe-filling and medication mixing dispenser |
US5354278A (en) | 1992-04-17 | 1994-10-11 | Science Incorporated | Fluid dispenser |
US5226900A (en) | 1992-08-03 | 1993-07-13 | Baxter International Inc. | Cannula for use in drug delivery systems and systems including same |
US5429607A (en) | 1994-03-09 | 1995-07-04 | I-Flow Corporation | Elastomeric syringe actuation device |
US5466220A (en) | 1994-03-08 | 1995-11-14 | Bioject, Inc. | Drug vial mixing and transfer device |
DE4414697C2 (en) | 1994-04-27 | 1998-06-18 | Caremed Vertriebsgesellschaft | Device for transferring and removing liquids from bottles, bags or similar containers for medical purposes |
DE4436350C1 (en) | 1994-10-12 | 1996-02-29 | Fresenius Ag | Implantable medical device |
CA2159052C (en) | 1994-10-28 | 2007-03-06 | Rainer Alex | Injection device |
US5993421A (en) | 1994-12-02 | 1999-11-30 | Science Incorporated | Medicament dispenser |
US5503628A (en) | 1995-03-15 | 1996-04-02 | Jettek, Inc. | Patient-fillable hypodermic jet injector |
US5962794A (en) | 1995-05-01 | 1999-10-05 | Science Incorporated | Fluid delivery apparatus with reservior fill assembly |
US6293159B1 (en) | 1995-05-01 | 2001-09-25 | Science Incorporated | Fluid delivery apparatus with reservoir fill assembly |
CA2151407A1 (en) | 1995-06-09 | 1996-12-10 | Duncan Newman | Injection device |
US5722956A (en) | 1995-08-24 | 1998-03-03 | The General Hospital Corporation | Multi-dose syringe driver |
AU7617296A (en) | 1995-12-06 | 1997-06-27 | Gabriel Meyer | Device for preparing a medicinal solution reconstituted from two components |
US5858001A (en) | 1995-12-11 | 1999-01-12 | Elan Medical Technologies Limited | Cartridge-based drug delivery device |
JP3142770B2 (en) * | 1996-01-26 | 2001-03-07 | 川澄化学工業株式会社 | Drug dissolution kit and drug dissolution / injection system |
US5785688A (en) | 1996-05-07 | 1998-07-28 | Ceramatec, Inc. | Fluid delivery apparatus and method |
US6045534A (en) | 1997-10-27 | 2000-04-04 | Sarcos, Inc. | Disposable fluid injection module |
IT236231Y1 (en) | 1997-11-24 | 2000-08-08 | Eurospital S P A | CONNECTION DEVICE FOR TWO PHARMACEUTICAL PRODUCT CONTAINERS TO MIX THE PRODUCTS IN THE SYSTEM |
US6071270A (en) | 1997-12-04 | 2000-06-06 | Baxter International Inc. | Sliding reconstitution device with seal |
JP2002508225A (en) | 1997-12-16 | 2002-03-19 | メリディアン メディカル テクノロジーズ,インコーポレイテッド | Automatic syringe |
US5957895A (en) | 1998-02-20 | 1999-09-28 | Becton Dickinson And Company | Low-profile automatic injection device with self-emptying reservoir |
US6209738B1 (en) | 1998-04-20 | 2001-04-03 | Becton, Dickinson And Company | Transfer set for vials and medical containers |
JP2000046360A (en) | 1998-07-29 | 2000-02-18 | Hitachi Ltd | Ceiling recessed indoor machine |
US6113583A (en) | 1998-09-15 | 2000-09-05 | Baxter International Inc. | Vial connecting device for a sliding reconstitution device for a diluent container |
FR2783430B1 (en) | 1998-09-23 | 2000-12-29 | Yves Jean Soulas | TORIC DEVICE FOR SECURED INJECTION BY A FLIP-DOWN NEEDLE |
AU1719800A (en) | 1998-11-13 | 2000-06-05 | Elan Pharma International Limited | Drug delivery systems and methods |
US6719719B2 (en) | 1998-11-13 | 2004-04-13 | Elan Pharma International Limited | Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same |
US20040069044A1 (en) | 1999-04-29 | 2004-04-15 | Gilad Lavi | Device for measuring a volume of drug |
DE10009814B4 (en) | 2000-03-01 | 2008-03-06 | Tecpharma Licensing Ag | Disposable injector |
US6485461B1 (en) | 2000-04-04 | 2002-11-26 | Insulet, Inc. | Disposable infusion device |
US6547764B2 (en) | 2000-05-31 | 2003-04-15 | Novo Nordisk A/S | Double pointed injection needle |
US6986760B2 (en) * | 2000-08-02 | 2006-01-17 | Becton, Dickinson And Company | Pen needle and safety shield system |
US6790199B1 (en) | 2000-09-28 | 2004-09-14 | North American Medical Products, Inc. | Needle protective assembly for multi-draw needle |
EP1767525A1 (en) | 2001-04-09 | 2007-03-28 | Novartis Vaccines and Diagnostics, Inc. | Guanidino compounds as melanocortin-4 receptor (MC4-R) agonists |
US20060122577A1 (en) | 2001-09-26 | 2006-06-08 | Poulsen Jens U | Modular drug delivery system |
ES2314182T3 (en) | 2002-02-11 | 2009-03-16 | Antares Pharma, Inc. | INTRADERMIC INJECTOR. |
BR0308694A (en) | 2002-03-26 | 2007-01-09 | Becton Dickinson Co | multistage fluid delivery device and method |
GB0208627D0 (en) | 2002-04-16 | 2002-05-22 | Imprint Pharm Ltd | Needle |
US6960192B1 (en) | 2002-04-23 | 2005-11-01 | Insulet Corporation | Transcutaneous fluid delivery system |
CN100479875C (en) | 2002-07-22 | 2009-04-22 | 贝克顿·迪金森公司 | Patch-like infusion device |
EP2526996B1 (en) | 2002-12-20 | 2019-09-11 | Xeris Pharmaceuticals, Inc. | Formulation for intracutaneous injection |
EP1454650B1 (en) | 2003-03-06 | 2007-10-10 | CSL Behring GmbH | Transfer device, in particular for medical fluids |
US7524308B2 (en) | 2003-04-16 | 2009-04-28 | Becton, Dickinson And Company | Safety shielding needle assembly with passive shielding |
EP1502613A1 (en) | 2003-08-01 | 2005-02-02 | Novo Nordisk A/S | Needle device with retraction means |
DK3395396T3 (en) | 2003-08-12 | 2020-09-28 | Becton Dickinson Co | Plaster-like infusion device |
US20050070874A1 (en) | 2003-09-30 | 2005-03-31 | Hikaru Matsuda | System and method for injecting liquid drug containing biological material |
EP1532996A1 (en) | 2003-11-20 | 2005-05-25 | Novo Nordisk A/S | Non grinded needle tip-geometry for an injection needle |
US7896841B2 (en) | 2004-02-17 | 2011-03-01 | Children's Hospital Medical Center | Injection device for administering a vaccine |
US7398802B2 (en) | 2004-09-02 | 2008-07-15 | Baker James W | System for dispensing biological fluids |
WO2006031500A2 (en) | 2004-09-10 | 2006-03-23 | Becton, Dickinson And Company | Reconstituting infusion device |
EP1838366B1 (en) | 2004-11-24 | 2013-03-13 | Becton, Dickinson and Company | Automatic reconstitution injector device |
US7959600B2 (en) | 2004-12-30 | 2011-06-14 | Byeong S. Chang | Container closure delivery system |
BRPI0614025A2 (en) | 2005-01-24 | 2012-12-25 | Antares Pharma Inc | jet injectors |
ATE529088T1 (en) * | 2005-08-11 | 2011-11-15 | Medimop Medical Projects Ltd | TRANSFER DEVICES FOR LIQUID MEDICINAL PRODUCTS FOR FAIL-SAFE CORRECT LATCH CONNECTION ON MEDICAL AMPOULES |
US7534226B2 (en) | 2005-09-26 | 2009-05-19 | M2 Group Holdings, Inc. | Dispensing fluid from an infusion pump system |
US7882863B2 (en) | 2005-10-19 | 2011-02-08 | Cd Solutions, Llc | Apparatus and method for mixing and transferring medications |
CA2631882C (en) | 2005-12-08 | 2015-02-10 | Nanopass Technologies Ltd. | Microneedle adapter for dosed drug delivery devices |
GB0605763D0 (en) | 2006-03-22 | 2006-05-03 | The Technology Partnership Plc | Ambulatory pump |
US7547300B2 (en) * | 2006-04-12 | 2009-06-16 | Icu Medical, Inc. | Vial adaptor for regulating pressure |
EP2012735A1 (en) | 2006-04-24 | 2009-01-14 | Novo Nordisk A/S | Transfer system for forming a drug solution from a lyophilized drug |
US8221354B2 (en) | 2006-04-27 | 2012-07-17 | Medtronic, Inc. | Infusion device with positive pressure elastic bladder reservoir |
US20070282269A1 (en) | 2006-05-31 | 2007-12-06 | Seattle Medical Technologies | Cannula delivery apparatus and method for a disposable infusion device |
US7806265B2 (en) | 2006-07-12 | 2010-10-05 | Mobius Therapeutics, Llc | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
US20100185177A1 (en) | 2006-09-05 | 2010-07-22 | Gillum Christoph L | Hands-free intramuscular injection device |
US8162923B2 (en) | 2006-09-06 | 2012-04-24 | Calibra Medical, Inc. | Disposable infusion device with automatic unlocking mechanism |
WO2008047372A2 (en) | 2006-10-19 | 2008-04-24 | Elcam Medical Agricultural Cooperative Association Ltd. | Automatic injection device |
US7637889B2 (en) | 2006-11-15 | 2009-12-29 | Glynntech, Inc. | Drug delivery device with sliding valve and methodology |
US7938801B2 (en) | 2006-11-22 | 2011-05-10 | Calibra Medical, Inc. | Disposable infusion device filling apparatus and method |
WO2008067506A1 (en) | 2006-11-30 | 2008-06-05 | Medi-Physics, Inc. | Dual-lumen needle |
US8684968B2 (en) | 2006-12-29 | 2014-04-01 | Aktivpak, Inc. | Hypodermic drug delivery reservoir and apparatus |
US7540858B2 (en) | 2007-01-23 | 2009-06-02 | Becton, Dickinson And Company | Retracting safety pen needle |
US8147477B2 (en) | 2007-04-27 | 2012-04-03 | Amylin Pharmaceuticals, Inc. | Mixing tool |
US7963954B2 (en) | 2007-04-30 | 2011-06-21 | Medtronic Minimed, Inc. | Automated filling systems and methods |
IL182922A0 (en) | 2007-05-02 | 2007-09-20 | Medimop Medical Projects Ltd | Automatic liquid drug reconstitution apparatus |
US20080312582A1 (en) | 2007-06-15 | 2008-12-18 | Peter Krulevitch | Method for inserting a flexible medical device conduit |
CN101918074B (en) | 2007-09-18 | 2013-02-27 | 麦迪麦珀医疗工程有限公司 | Medicament mixing and injection apparatus |
DE102007055635A1 (en) | 2007-11-21 | 2009-05-28 | Robert Bosch Gmbh | System for administering a liquid medicament |
EP2214757A1 (en) | 2007-11-22 | 2010-08-11 | Novo Nordisk Health Care AG | Medical mixing device |
DE102007061346A1 (en) | 2007-12-17 | 2009-06-18 | Bayer Schering Pharma Aktiengesellschaft | Spike with two thorns |
US7815609B2 (en) | 2007-12-19 | 2010-10-19 | Calibra Medical, Inc. | Disposable infusion device positive pressure filling apparatus and method |
US7976505B2 (en) | 2007-12-19 | 2011-07-12 | Calibra Medical, Inc. | Disposable infusion device negative pressure filling apparatus and method |
US8545440B2 (en) | 2007-12-21 | 2013-10-01 | Carticept Medical, Inc. | Injection system for delivering multiple fluids within the anatomy |
EP2231230A4 (en) | 2007-12-21 | 2013-01-23 | Carticept Medical Inc | Articular injection system |
WO2009088956A2 (en) | 2007-12-31 | 2009-07-16 | Deka Products Limited Partnership | Infusion pump assembly |
USD631153S1 (en) | 2008-01-07 | 2011-01-18 | I-Flow Corporation | Elastic housing for infusion device |
FR2928539B1 (en) | 2008-03-12 | 2012-02-24 | Vygon | INTERFACING DEVICE FOR PERFORATING BOTTLES FOR THE PREPARATION OF PERFUME FLUIDS |
GB2461086B (en) | 2008-06-19 | 2012-12-05 | Cilag Gmbh Int | Injection device |
US8128597B2 (en) | 2008-06-26 | 2012-03-06 | Calibra Medical, Inc. | Disposable infusion device with cannula port cover |
MX2009007170A (en) | 2008-06-30 | 2010-02-17 | Animas Corp | Volumetric micropump. |
EP2303362B1 (en) | 2008-07-18 | 2019-06-05 | Becton, Dickinson and Company | Dual chamber and gear pump assembly for a high pressure delivery system |
ES2809275T3 (en) | 2008-09-18 | 2021-03-03 | Becton Dickinson Co | Push Button Activation Medical Injector |
EP2328640B1 (en) | 2008-09-18 | 2016-12-21 | Becton, Dickinson and Company | Medical injector with post-autoreconstitution dose setting and autoplunger drive |
CN102159267B (en) | 2008-09-18 | 2013-08-07 | 贝克顿·迪金森公司 | Container for injection device with injection needle |
CN102186447B (en) | 2008-10-15 | 2013-06-19 | 诺沃—诺迪斯克保健股份有限公司 | System for reconstitution of powdered drug |
US20100130958A1 (en) | 2008-11-26 | 2010-05-27 | David Kang | Device and Methods for Subcutaneous Delivery of High Viscosity Fluids |
EP2196231B1 (en) | 2008-12-12 | 2013-02-27 | F. Hoffmann-La Roche AG | System for ambulatory drug infusion comprising a filling apparatus for flexible containers |
GB0900930D0 (en) | 2009-01-20 | 2009-03-04 | Future Injection Technologies Ltd | Injection device |
GB2467904B (en) | 2009-02-17 | 2013-06-12 | Oval Medical Technologies Ltd | Drug container and delivery mechanism |
US8579865B2 (en) | 2009-03-20 | 2013-11-12 | Antares Pharma, Inc. | Hazardous agent injection system |
JP5685579B2 (en) | 2009-04-14 | 2015-03-18 | ユーコン・メディカル,リミテッド・ライアビリティ・カンパニー | Fluid transfer device |
EP2437715B1 (en) | 2009-06-02 | 2018-01-17 | Yukon Medical, LLC | Multi-container transfer and delivery device |
BR122012017389B8 (en) | 2009-07-01 | 2021-06-22 | Fresenius Medical Care Holdings Inc | drug delivery device |
DK2319477T3 (en) | 2009-11-06 | 2012-04-23 | Hoffmann La Roche | Device for filling a flexible storage container in a vacuum chamber |
US8348898B2 (en) | 2010-01-19 | 2013-01-08 | Medimop Medical Projects Ltd. | Automatic needle for drug pump |
EP2552518A4 (en) * | 2010-04-01 | 2014-08-13 | Enable Injections Llc | Medical fluid injection device and system |
EP2397169A1 (en) | 2010-06-15 | 2011-12-21 | CSL Behring GmbH | Bracket for an injection needle |
KR101802548B1 (en) | 2010-06-09 | 2017-11-28 | 발레리타스 인코포레이티드 | Fluid delivery device needle retraciton mechanisms, cartridges and expandable hydraulic fluid seals |
WO2011159714A2 (en) | 2010-06-14 | 2011-12-22 | Duncan David R | Medication infusion kit |
KR20130098996A (en) | 2010-08-10 | 2013-09-05 | 에프. 호프만-라 로슈 아게 | Drug reconstitution and delivery device |
US8523814B2 (en) | 2010-09-28 | 2013-09-03 | Covidien Lp | Self-venting cannula assembly |
EP2468333A1 (en) | 2010-12-21 | 2012-06-27 | Sanofi-Aventis Deutschland GmbH | Auto-injector |
WO2012099898A2 (en) | 2011-01-17 | 2012-07-26 | Aktivpak, Inc. | Aseptic cartridge and dispenser arrangement |
US8968242B2 (en) | 2012-02-10 | 2015-03-03 | Avent, Inc. | Inflatable elastomeric pump for an infusion assembly |
FR2990136B1 (en) | 2012-05-02 | 2015-06-19 | Pharmadyne | KIT FOR RECHARGING AN INFUSION PUMP, METHOD OF PREPARING AND USING THE SAME |
EP2803348A1 (en) | 2013-05-15 | 2014-11-19 | hameln rds gmbh | Process for filling of syringes for dosing pumps |
JP6691041B2 (en) | 2013-06-18 | 2020-04-28 | イネイブル インジェクションズ、インコーポレイテッド | Vial transfer and injection devices and methods |
EP2832390A1 (en) | 2013-07-30 | 2015-02-04 | Sensile Pat AG | Drug delivery device with needle actuation mechanism |
EP2842586A1 (en) | 2013-08-27 | 2015-03-04 | PharmaSens AG | Device with a lavet-type motor |
CN110141719B (en) | 2013-12-19 | 2022-05-27 | 美敦力迷你迈德公司 | On-body injector and method of use |
US10265466B2 (en) | 2014-04-24 | 2019-04-23 | Becton, Dickinson And Company | Fluid infusion device |
-
2013
- 2013-09-12 WO PCT/US2013/059359 patent/WO2014046950A1/en active Application Filing
- 2013-09-12 US US14/423,938 patent/US20150217058A1/en not_active Abandoned
-
2017
- 2017-04-07 US US15/481,753 patent/US10729842B2/en active Active
-
2020
- 2020-07-08 US US16/923,612 patent/US20200338257A1/en active Pending
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3094988A (en) * | 1961-09-18 | 1963-06-25 | Dunmire Hannah | Hypodermic ampoules |
US3797490A (en) * | 1971-02-11 | 1974-03-19 | Ampoules Inc | Hypodermic ampoule with skin tensioning clip |
US5527288A (en) * | 1990-12-13 | 1996-06-18 | Elan Medical Technologies Limited | Intradermal drug delivery device and method for intradermal delivery of drugs |
US20040116847A1 (en) * | 2002-09-12 | 2004-06-17 | Children's Hospital Medical Center | Method and device for painless injection of medication |
US20090054866A1 (en) * | 2005-01-24 | 2009-02-26 | Novo Nordisk A/S | Transcutaneous Device Assembly |
US20110092883A1 (en) * | 2009-10-16 | 2011-04-21 | Kenichi Uchiyama | Transdermal drug administration apparatus and transdermal drug administration unit |
US20130324884A1 (en) * | 2010-10-11 | 2013-12-05 | Paul Hadváry | Syringe type pump |
US20130060233A1 (en) * | 2011-09-02 | 2013-03-07 | Unitract Syringe Pty Ltd | Insertion mechanism for a drug delivery pump |
US20140236089A1 (en) * | 2011-09-23 | 2014-08-21 | Ambro B.V. | System for transporting fluid across or into a biological barrier, device and capsule as part of the system |
Cited By (12)
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US11617827B2 (en) | 2005-09-12 | 2023-04-04 | Unomedical A/S | Invisible needle |
US11786653B2 (en) | 2010-03-30 | 2023-10-17 | Unomedical A/S | Insertion device |
US11317944B2 (en) | 2011-03-14 | 2022-05-03 | Unomedical A/S | Inserter system with transport protection |
US11197689B2 (en) | 2011-10-05 | 2021-12-14 | Unomedical A/S | Inserter for simultaneous insertion of multiple transcutaneous parts |
US11110261B2 (en) | 2011-10-19 | 2021-09-07 | Unomedical A/S | Infusion tube system and method for manufacture |
US11684767B2 (en) | 2011-10-19 | 2023-06-27 | Unomedical A/S | Infusion tube system and method for manufacture |
US11357912B2 (en) | 2016-01-19 | 2022-06-14 | Unomedical A/S | Cannula and infusion devices |
US11458292B2 (en) | 2019-05-20 | 2022-10-04 | Unomedical A/S | Rotatable infusion device and methods thereof |
US11944775B2 (en) | 2019-05-20 | 2024-04-02 | Unomedical A/S | Rotatable infusion device and methods thereof |
US11771841B2 (en) | 2020-12-23 | 2023-10-03 | Tolmar International Limited | Systems and methods for mixing syringe valve assemblies |
US11931559B2 (en) | 2020-12-23 | 2024-03-19 | Tolmar International Limited | Systems and methods for mixing syringe valve assemblies |
USD1029245S1 (en) | 2022-06-22 | 2024-05-28 | Tolmar International Limited | Syringe connector |
Also Published As
Publication number | Publication date |
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US20170209642A1 (en) | 2017-07-27 |
WO2014046950A1 (en) | 2014-03-27 |
US10729842B2 (en) | 2020-08-04 |
US20150217058A1 (en) | 2015-08-06 |
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