US20190328960A1 - Medicine Delivery Device with Restricted Access Filling Port - Google Patents
Medicine Delivery Device with Restricted Access Filling Port Download PDFInfo
- Publication number
- US20190328960A1 US20190328960A1 US16/425,181 US201916425181A US2019328960A1 US 20190328960 A1 US20190328960 A1 US 20190328960A1 US 201916425181 A US201916425181 A US 201916425181A US 2019328960 A1 US2019328960 A1 US 2019328960A1
- Authority
- US
- United States
- Prior art keywords
- patch pump
- filling
- shutter
- adapter
- medicament
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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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
- A61M5/14—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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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
- F16L29/00—Joints with fluid cut-off means
- F16L29/02—Joints with fluid cut-off means with a cut-off device in one of the two pipe ends, the cut-off device being automatically opened when the coupling is applied
-
- 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
- A61M2005/1426—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with means for preventing access to the needle after use
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M2039/0036—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
- A61M2039/009—Means for limiting access to the septum, e.g. shields, grids
-
- 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
- A61M2209/00—Ancillary equipment
- A61M2209/04—Tools for specific apparatus
- A61M2209/045—Tools for specific apparatus for filling, e.g. for filling reservoirs
Definitions
- the invention relates generally to wearable infusion pump devices (e.g., patch pumps) and other medical delivery devices having a filling port for filling the device with medicament and, more particularly, to systems and methods for preventing unauthorized filling of the device.
- wearable infusion pump devices e.g., patch pumps
- other medical delivery devices having a filling port for filling the device with medicament and, more particularly, to systems and methods for preventing unauthorized filling of the device.
- Infusion devices are often used to deliver medicament (e.g., insulin) to a user.
- medicament e.g., insulin
- an exposed septum on the device can be pierced by a hollow needle, allowing for the transfer of any substance that can move through the hollow needle into the device. This can lead to unintended uses and pose a risk to the user.
- An objective of the invention is to provide a lock and key type filling interface, in which the pump body includes one or more components forming a portion of the lock and an adapter forms corresponding mating key components. In this manner, access to fill the pump is limited to individuals possessing the adapter key, the manufacture and distribution of which may be suitably controlled.
- a shutter and/or a valve may only be opened with the key, which key may have a specific mechanical shape, a specific distance between a needle and a coupling feature, and/or a specific length of the coupling feature.
- One or more components of the lock and key may be made sterile as necessary, and single use features may be incorporated in the pump and/or adapter components to preclude unauthorized reuse of single-use components.
- Another objective of the invention to prevent user error.
- One type of user error occurs when an incorrect type of medicament is used. By limiting delivery of the adapter with a specific type(s) of insulin, it is unlikely the adapter would be used with another, unauthorized medicament container.
- Another form of user error can occur through needle injury, such as “sticking”
- Certain features e.g., the key
- needle injury can be designed to protect against needle injury, such as by recessing the needle relative to another surface or covering the needle.
- User error may also occur when a user injects medicament into any other soft element (e.g., soft control buttons) on the patch pump device and not the filling port septum.
- Protecting the septum may make it difficult, if not impossible, to fill the device through any access other than the filling port, which filling port may only be accessed with the key.
- This configuration is especially useful in patch pumps and other medical delivery devices with a single port, although this configuration can also be used with multiple port pumps.
- Embodiments of insulin and other medicament infusion devices such as disposable patch pumps that adhere to a patients skin include a restricted insulin filling port.
- the filling port includes a movable cover mechanism (e.g., a shutter) that obstructs access to the filling port or a portion of the port, such as a needle piercing septum.
- the shutter can be automatically retracted to expose the septum when a unique adapter is mated with the filling port.
- Some embodiments have a sliding, rotating, or cantilevered shutter that is retracted, moved, or displaced with an adapter to provide access to the septum for filling the device with insulin.
- the adapter may uniquely interface with a housing of the device, so that the shutter may only be opened with a specific matching adapter, e.g., through a unique mating configuration or design.
- the adapter is inserted into the patch pump base and rotated to shift or retract the shutter.
- a medicament container e.g., a syringe, a pen, a cartridge, or a vial containing insulin or other medicament
- Embodiments of the system advantageously prevent filling of the patch pump directly with a conventional syringe.
- the adapter is disposed at the end of an insulin delivery apparatus (or a medicament container) and provided with a standard 3 mL cartridge of insulin.
- the adapter is pushed into the pump base and rotated to open the shutter and expose the septum. The delivery apparatus is pushed further and then the cartridge is emptied into the pump reservoir.
- the vehicle is preloaded with insulin instead of using a removable cartridge.
- the adapter may be used to secure a vial for withdrawing fluid into the delivery apparatus syringe, and the same adapter may be used to couple the device to the pump and fill the pump with insulin.
- a vial may be coupled directly to the adapter which couples directly to the device.
- Various combinations of elements and kits can be delivered together, including pump(s), adapters, syringes, and medicament containers (e.g., vials, cartridges, pens, etc.).
- the invention in one aspect, relates to a patch pump system.
- the patch pump system has a patch pump device with a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position.
- the patch pump system also has a filling adapter adapted to be coupled to the filling port and move the shutter from the closed position to the open position.
- the filling port has a septum.
- the filling port may be accessible from a user contact side of the patch pump device.
- the shutter is accessible from a user contact side of the patch pump device.
- the shutter may be disposed within the patch pump device, and the shutter may be disposed within the filling port.
- the shutter can define a shutter opening, such that the shutter is in the open position when the shutter opening is aligned with a septum of the filling port.
- the shutter is a valve or further includes a valve.
- the patch pump device defines a device opening for coupling the filling adapter to the filling port and enabling controlled movement of the shutter.
- the filling adapter may have a mating surface adapted to fit in the device opening.
- the mating surface may have a protrusion and/or the mating surface may be adapted to contact the shutter.
- the filling adapter has a hollow needle. The needle may be exposed on two sides and be adapted to pierce two septa simultaneously.
- a first end of the filling adapter may be adapted to mate with a medicament container, which may be medicament container may be a syringe, a pen, a cartridge, and/or a vial.
- the patch pump system also has a socket adapted to receive the filling adapter, which socket may be adapted to support rotation of the filling adapter.
- the invention in another aspect, relates to a filling adapter for use with a patch pump device.
- the filling adapter has a first end adapted to mate with a medicament container and a second end adapted to couple to a filling port of a patch pump device and to move a shutter of the patch pump device from a closed position to an open position.
- the first end defines a recess for receiving the medicament container.
- the first end may have a needle for piercing the medicament container.
- the medicament container may be a syringe, a pen, a cartridge, and/or a vial.
- the second end may have a needle.
- the second end has a protrusion adapted to extend into the patch pump device, such as a resilient tab. At least one of the first end and the second end may have a frangible component adapted to break after a single use.
- the invention in another aspect, relates to a method of filling a patch pump device.
- the method includes coupling a first end of a filling adapter to a medicament container, coupling a second end of the filling adapter to a filling port on a patch pump device to move a shutter proximate the filling port from a closed position preventing access to the filing port to an open position allowing access to the filling port, and filling a reservoir of the patch pump device with medicament from the medicament container via the filling port.
- coupling the first end of the filling adapter to the medicament container includes receiving at least a portion of the medicament container in a recess of the filling adapter.
- Coupling the first end of the filling adapter to the medicament container may include piercing the medicament container with a needle.
- Coupling the second end of the filling adapter to the filling port on the patch pump device may include inserting a mating surface of the second end into the patch pump device, and may include rotating the filling adapter to move the shutter.
- the inserting step moves the shutter to the open position.
- the medicament container may be a syringe, a pen, a cartridge, and/or a vial. Filling the reservoir can include transferring medicament from the medicament container under pressure.
- the method may also include, after coupling the first end of the filling adapter to the medicament container, drawing medicament into the medicament container. The medicament may be drawn from a vial coupled to the second end.
- the invention in another aspect, relates to a patch pump device.
- the patch pump device has a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port when in the closed position, wherein the shutter comprises at least one mating surface adapted to couple to a filling adapter to move the shutter to the open position.
- the invention in another aspect, relates to a filling system adapted for use with a patch pump device.
- the filling system includes a filling adapter having a first end adapted to receive a medicament container and a second end adapted to mate with a filling port of a patch pump device and move a shutter of the patch pump device from a closed position to an open position.
- the filling system also includes a medicament container.
- the invention in another aspect, relates to a patch pump kit.
- the patch pump kit includes a patch pump device with a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port when in the closed position.
- the patch pump kit also includes a filling adapter with a first end adapted to receive a medicament container and a second end adapted to mate with the filling port and move from the closed position to the open position.
- the patch pump kit also includes a medicament container.
- the invention in another aspect, relates to a filling adapter kit.
- the filling adapter kit includes a medicament container adapter, a syringe adapter, and a pump device filling port adapter.
- At least a portion of the syringe adapter is adapted to actuate a shutter disposed in a pump device to move the shutter from a closed position to an open position.
- the invention in another aspect, relates to a patch pump kit.
- the patch pump kit includes a patch pump device with a filling port and a shutter movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position.
- the patch pump kit also includes a filling pump device adapted to mate with the filling port and move the shutter to the open position.
- the filling pump device includes an inlet for receiving a medicament container, an outlet for mating with the filling port, and a pump for transferring medicament from the inlet to the outlet.
- the patch pump kit also includes an adapter for mating the medicament container to the inlet.
- FIG. 1A shows a perspective view of an illustrative embodiment of an adapter key in accordance with the present invention
- FIG. 1B shows a cross-sectional view of the adapter key of FIG. 1A in accordance with some embodiments of the present invention
- FIG. 1C shows a perspective view of an illustrative embodiment of a socket in accordance with the present invention
- FIG. 1D shows a top view of an illustrative embodiment of a shutter in accordance with the present invention
- FIG. 2A shows a cross-sectional view of the adapter key of FIG. 1A coupled to a medicament container in accordance with some embodiments of the present invention
- FIGS. 2B and 2C show perspective views of a medicament delivery system with the adapter key of FIG. 1A in accordance with some embodiments of the present invention
- FIG. 3A shows a perspective view of a medicament delivery system coupled to a patch pump system in accordance with some embodiments of the present invention
- FIG. 3B shows a bottom view of the coupled medicament delivery system of FIG. 3A in which the shutter is in a first closed position in accordance with some embodiments of the present invention
- FIG. 3C shows a cross-sectional detail of the coupled medicament delivery system of FIG. 3A in which the shutter is in an open position in accordance with some embodiments of the present invention
- FIG. 3D shows a bottom view of the coupled medicament delivery system of FIG. 3A in which the shutter is in the open position in accordance with some embodiments of the present invention
- FIG. 3E shows cross-sectional detail of the coupled medicament delivery system of FIG. 3A in which the shutter is in the open position in accordance with some embodiments of the present invention and the needle has pierced a septum fluidically coupled to a reservoir in the patch pump system in accordance with some embodiments of the present invention;
- FIG. 3F shows a cross-sectional detail of the coupled medicament delivery system of FIG. 3A in which the needle has been retracted and the shutter has been re-closed to a second position in accordance with some embodiments of the present invention
- FIG. 3G shows a bottom view of the medicament delivery system and patch pump system of FIG. 3A with the shutter re-closed to the second position in accordance with some embodiments of the present invention
- FIGS. 4A and 4B show perspective views of a second adapter key in accordance with some embodiments of the present invention.
- FIG. 5A shows a perspective views of an illustrative embodiment of a valve-type shutter for use with the adapter key of FIGS. 4A and 4B in accordance with the present invention
- FIG. 5B shows a cross-sectional view of the valve-type shutter of FIG. 5A in accordance with the present invention
- FIG. 5C shows a cross-sectional view of an embodiment of a valve-type shutter having two fluid outlet paths in an open state for use with the adapter key of FIGS. 4A and 4B in accordance with the present invention
- FIG. 6A shows a bottom perspective view of the valve-type shutter disposed at a first location within a ratchet-type system within the patch pump system for use with the adapter key of FIGS. 4A and 4B in accordance with some embodiments of the present invention
- FIG. 6B shows a bottom perspective view of the valve-type shutter disposed at a second location within the ratchet-type system within the patch pump system for use with the adapter key of FIGS. 4A and 4B in accordance with some embodiments of the present invention
- FIG. 7A shows a cross-sectional view of the second adapter key of FIGS. 4A and 4B mounted in the valve-type shutter of FIGS. 5A and 5B in a dosed position in accordance with some embodiments of the present invention
- FIG. 7B shows a bottom view of the coupled valve-type shutter and adapter key of FIG. 7A with a resilient tab disposed at a first location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention
- FIG. 7C shows a cross-sectional view of the second adapter key of FIGS. 4A and 4B mounted in the valve-type shutter of FIGS. 5A and 5B in an open position accordance with some embodiments of the present invention
- FIG. 7D shows a bottom view of the coupled valve-type shutter and adapter key of FIG. 7C with a resilient tab disposed at a second location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention
- FIG. 7E shows a bottom view of the coupled valve-type shutter and adapter key of FIG. 7A with a resilient tab disposed at a third location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention
- FIG. 8A shows a perspective view of an adapter key for use with a syringe in accordance with some embodiments of the present invention
- FIG. 8B shows a cross-sectional view of the adapter key of FIG. 8A in accordance with some embodiments of the present invention
- FIGS. 9A and 9B show perspective views of an illustrative embodiment of a syringe-type medicament delivery system having the adapter key of FIG. 8A in accordance with the present invention
- FIGS. 9C and 9D show perspective views of the syringe-type medicament delivery system of FIGS. 9A and 9B and a medicament vial in accordance with the present invention
- FIG. 9E shows a cross-sectional view of the adapter key of FIG. 8A coupled to a medicament vial of FIG. 9D in accordance with some embodiments of the present invention
- FIG. 10A shows a cross-sectional detail of the medicament delivery system of FIG. 9B and patch pump system with a closed shutter in accordance with some embodiments of the present invention
- FIG. 10B shows a cross-sectional detail of the medicament delivery system of FIG. 9B and patch pump system with an open shutter in accordance with some embodiments of the present invention
- FIG. 10C shows a cross-sectional detail of the medicament delivery system of FIG. 9B in which the needle has pierced the septum of the patch pump system in accordance with some embodiments of the present invention
- FIG. 10D shows a cross-sectional detail of the medicament delivery system of FIG. 9B and patch pump system in which the shutter is re-closed in accordance with some embodiments of the present invention
- FIG. 11A shows a perspective view of an adapter key with a safety tab for use with a syringe in accordance with some embodiments of the present invention
- FIG. 11B shows a cross-sectional view of the adapter key of FIG. 11A in accordance with some embodiments of the present invention
- FIGS. 12A and 12B show perspective views of an illustrative embodiment of a syringe-type medicament delivery system having the adapter key of FIG. 11A in accordance with the present invention
- FIG. 12C shows a perspective view of the safety-tabbed syringe-type medicament delivery system of FIGS. 11A and 11B and a medicament vial in accordance with the present invention
- FIG. 12D shows a cross-sectional view of the safety-tabbed adapter key of FIG. 11A coupled to a medicament vial in accordance with some embodiments of the present invention
- FIG. 13A shows a perspective view of an arcuate shutter for use with another medicament delivery system in accordance with some embodiments of the present invention
- FIG. 13B shows a perspective view of a socket in accordance with some embodiments of the present invention.
- FIG. 13C shows a perspective view of an adapter key for use with another medicament delivery system in accordance with some embodiments of the present invention.
- FIG. 13D shows a perspective view of a cap for a medicament vial for use with another medicament delivery system in accordance with some embodiments of the present invention
- FIG. 14 a shows a perspective view of a medicament delivery system with the adapter key of FIG. 13C in accordance with some embodiments of the present invention
- FIG. 14 b shows a perspective view of the medicament delivery system of FIG. 14 a coupled to a medicament vial in accordance with some embodiments of the present invention
- FIG. 14C shows a cross-sectional view of the adapter key of FIG. 13C coupled to a medicament vial in accordance with some embodiments of the present invention
- FIG. 15A shows a perspective view of the medicament delivery system of FIG. 14 a aligned over the socket of a patch pump system in accordance with some embodiments of the present invention
- FIG. 15B shows a perspective view of the medicament delivery system of 14 a coupled with the socket of a patch pump system in accordance with some embodiments of the present invention
- FIG. 16A shows a cross-sectional detail of the coupled medicament delivery system of FIG. 15B with the arcuate shutter in a closed position in accordance with some embodiments of the present invention
- FIG. 16B shows a bottom view of the coupled shutter and adapter key of FIG. 16A in accordance with some embodiments of the present invention
- FIG. 16C shows cross-sectional detail of the coupled medicament delivery system of FIG. 15B with the arcuate shutter in an open position in accordance with some embodiments of the present invention
- FIG. 16D shows a bottom view of the coupled shutter and adapter key of FIG. 16C in accordance with some embodiments of the present invention
- FIG. 16E shows cross-sectional detail of the coupled medicament delivery system of FIG. 15B with the hollow needle piercing the septum of the patch pump system in accordance with some embodiments of the present invention
- FIG. 16F shows a bottom view of the coupled shutter and adapter key of FIG. 16E in accordance with some embodiments of the present invention.
- FIG. 17 shows a perspective view of a contained medicament delivery system coupled with a patch pump system in accordance with some embodiments of the present invention
- FIG. 18 shows a cross-sectional view of the coupled medicament delivery system of FIG. 17 in a closed position and having a medicament vial attached in accordance with some embodiments of the present invention.
- FIG. 19 shows a cross-sectional detail of an activating pin of the contained medicament delivery system of FIG. 17 in accordance with some embodiments of the present invention.
- FIGS. 1A-3G A patch pump system 30 and uniquely-keyed medicament delivery system 40 in accordance with one embodiment of the present invention are depicted in FIGS. 1A-3G .
- the patch pump system 30 and keyed medicament delivery system 40 are structured and arranged to mate or couple with a guiding socket 13 to provide a lock-and-key-type filling interface.
- access for filling a medicament reservoir or pump 17 of the patch pump system 30 is limited to individuals possessing the filling adapter or adapter key 20 a, the manufacture and distribution of which may be suitably controlled to prevent coupling with and/or filling the patch pump system 30 using unauthorized or improper medicaments, or by unauthorized individuals.
- the patch pump system 30 includes a guiding socket 13 , a key-lock filling port 32 , and a movable, e.g., rotatable, shutter 14 a that are integrated on or into the user contact side 31 of the patch pump system 30 .
- the socket 13 which may be disposed on the surface of the user contact side 31 , is provided as an initial guide for the adapter key 20 a.
- the socket 13 may define an opening 15 and may be shaped and dimensioned to accommodate the outer peripheral surface and/or a rim 25 of the adapter key 20 a.
- the socket 13 may also include one or more elastic expansion elements 12 that are structured and arranged to displace radially when the adapter key 20 a is inserted into and rotated within the socket opening 15 and oriented to position the shutter 14 a in an open (uncovered) state.
- the shutter 14 a may be configured to cover and uncover a septum 16 that seals the reservoir or pump 17 .
- the shutter 14 a may have a rounded T-shape having a central portion 19 and two wing portions 18 .
- a central, elongate opening 11 adapted to receive a protrusion 26 of the adapter key 20 a and a pin 29 about which the shutter 14 a may rotate, may be provided in the central portion 19 of the shutter 14 a.
- the shutter 14 a is disposed beneath the user contact side 31 of the patch pump system 30 ( FIG. 3B ), such that the pin 29 is disposed within a distal end of the elongate opening 11 .
- the shutter 14 a is configured to rotate about the pin 29 upon application of a rotating force or torque to the protrusion 26 of the adapter key 20 a.
- the shutter 14 a has been described as having a rounded T-shape, those of ordinary skill in the art can appreciate that a myriad of, for example, rounded and polygonal shapes may be used to effect the purpose and function of the shutter 14 a.
- the shutter may be L-shaped, I-shaped, rectangular, triangular, and so forth.
- the key-lock filling port 32 includes an opening in the user contact side 31 of the patch pump system 30 and the septum 16 , which may be pierced, e.g., by a hollow needle 22 , before the reservoir or pump 17 can be filled with a measured amount of medicament.
- the shutter 14 a covers and uncovers the filling port 32 , respectively, to protect the septum 16 from and to expose the septum 16 to the needle 22 of the adapter key 20 a in addition to the shutter 14 a, the patch pump system 30 may also include a receptacle 33 to provide another degree of security from improper medicament containers 35 .
- the receptacle 33 may be adapted to position the medicament delivery system 35 in a desired location before enabling delivery of a measured amount of medicament and, moreover, may be dimensioned to receive a safety protrusion 24 that may be formed in the adapter key 20 a.
- the safety protrusion 24 and receptacle 33 are structured and arranged to mate or couple, so that, only when a proper medicament container 35 is being used can the safety protrusion 24 advance into the receptacle 33 , enabling the hollow needle 22 to penetrate the septum 16 .
- the keyed medicament delivery system 40 includes a medicament container 35 , e.g., a pen and/or a cartridge pre-filled with a measured amount of insulin, and an adapter key 20 a that provides a fluidic connection between the medicament container 35 and a reservoir 17 in the patch pump device 30 , e.g., for the purpose of filling the reservoir 17 with a measured amount of a medicament.
- the adapter key 20 a includes a first end 21 and a second end 23 , each of which includes a hollow, cylindrical or substantially cylindrical portion.
- the hollow portions of the first end 21 and second end 23 are separated by a wall 28 through which a hollow needle 22 passes.
- the hollow needle 22 may be contained or recessed within the adapter key 20 a or, more particularly, within the hollow portions at the first 21 and second ends 23 of the adapter key 20 a.
- the first end 21 and the second end 23 of the adapter key 20 a may be movable with respect to each other, such that the medicament container 35 can be urged to force the hollow needle 22 through the septum 16 of the filling port 32 , e.g., by sliding, e.g., in an axial direction, the first end 21 of the adapter key 20 a relative to the second end 23 of the adapter key 20 a.
- the first end 21 may include a raised, alignment device 111 formed on the outer, peripheral surface of the first end 21 .
- the alignment device 111 can be structured and arranged to mate or couple with a receiving groove or track defined by the inner surface of the second end 23 .
- the groove or track may be dimensioned to receive the alignment device 111 .
- the alignment device 111 and groove combination position and guide the first end 21 with respect to the second end 23 while the first end 21 slidingly translates into and within the second end 23 during the septum piercing process and medicament delivery.
- the first end 21 of the adapter key 20 a is further configured to receive and to pierce a septum or seal 37 of the medicament container, e.g., by axial pressing and/or twisting, while the second end 23 of the adapter key 20 a may be coupled to the socket 13 of the patch pump device 30 .
- the first end 21 is adapted to mate with a medicament container 35 at a first end 39 thereof.
- the first end 39 of the medicament container 35 includes a fitting 38 for releasably connecting, e.g., by close sliding fit, with threadings, or the like, the medicament container 35 to the first end of 21 the adapter key 20 a.
- the hollow needle 22 of the adapter key 20 a is located to pierce the septum 37 of the medicament container 35 , during attachment.
- the first end 21 of the adapter key 20 a may also include an additional safety feature, e.g., a safety protrusion 24 , that is cantilevered axially from the wall 28 .
- the safety protrusion 24 is configured to prevent the premature deployment of the needle 22 , e.g., until the filling port shutter 14 a is opened and the needle 22 and the septum 16 are properly aligned. Once mated in a receptacle 33 in the patch pump system 30 , the safety protrusion 24 aligns with the receptacle 33 ( FIG. 3C ) to enable advancement of the needle 22 into and through the septum 16 .
- the second end 23 of the adapter key 20 a may include a rim 25 having a desired shaped and dimensions and on which a protrusion 26 is formed.
- the shape and dimension of the rim 25 can be selected to mate with the opening 15 of the socket 13 on the user contact side 31 of the patch pump system 30 .
- FIGS. 3A-3G illustrate an embodiment of a method of filling the reservoir 17 of a patch pump system 30 using the medicament delivery system 40 described above.
- a first step FIGS. 3A and 3B
- the adapter key 20 a is inserted into the socket 13 of the patch pump system 30 .
- the shutter 14 a is in a closed position, hence, the septum 16 of the reservoir 17 is covered by one of the wings 18 of the T-shaped shutter 14 a.
- FIGS. 3A and 3B illustrates an embodiment of a method of filling the reservoir 17 of a patch pump system 30 using the medicament delivery system 40 described above.
- a second step FIGS.
- the medicament container 35 and the patch pump system 30 and, more specifically, the needle 22 is aligned with the septum 16 , in preparation for piercing the septum 16 and for delivery of the medicament.
- alignment can be achieved, for example, by rotation of the medicament container 35 and the adapter key 20 a within the socket 13 .
- the protrusion 26 on the rim 25 of the adapter key 20 a slides along the peripheral wall of the elongate opening 11 of the shutter 14 a, urging the shutter 14 a such that the proximal end of the elongate opening 11 is aligned with the filling port 32 and the septum 16 .
- Neither wing 18 of the shutter 14 a covers the port 32 or septum 16 .
- the socket 13 guides and controls rotation and, advantageously, locks the adapter 20 a in place. e.g., using the elastic expansion elements 12 and/or a resilient detent, when in the proper position for piercing the septum 16 and for filling the reservoir 17 .
- the first end 21 slides in an axial direction within the second end 23 .
- the needle 22 is advanced to the delivery position, piercing the septum 16 and allowing for the delivery of medicament to the reservoir 17 in the patch pump device 30 .
- the medicament delivery system 40 can be retracted, e.g., by twisting and lifting the medicament container 35 ( FIGS. 3F and 3G ), to remove and disengage the adapter 20 a and medicament container 35 from the patch pump device 30 and to re-close the shutter 14 a.
- the container 35 and adapter 20 a are twisted past the shutter open position, to cover the port 32 and septum 16 with the second lobe or wing 18 of the shutter 14 a.
- the system 10 could be rotated in the opposite direction to cover the port 32 and septum 16 with the first lobe or wing 18 of the shutter 14 a.
- certain features, such as the safety protrusion 24 may be frangible so as to break off after filling has been completed, e.g., through twisting while the safety protrusion 24 is contained within the receptacle 33 to the second, re-closed position.
- a medicament container 35 e.g., a pen, a cartridge, and/or a vial
- a medicament container 35 can be coupled to a first end 21 of a second embodiment of an unique adapter key 20 b, which is adapted to receive the medicament container 35
- a second end 23 of the unique adapter key 20 b is adapted to mate or couple to a patch pump device 30 via a valve-type shutter 14 b.
- the shutter 14 b may be a valve that is axially rotatable to open or close a fluid path between the needle 22 and the reservoir 17 of the patch pump device 30 when the adapter key 20 b and shutter 14 b properly aligned.
- the shutter 14 b may have one or more resilient tabs 57 , 58 that are designed to deflect more easily in one direction of rotation than another, e.g., for use within a patch pump device 30 having a surrounding ratchet-type configuration 72 ( FIGS. 5A, 6A, and 6B ).
- rotation of the shutter 14 b may occur in only one direction, e.g. clockwise, and such rotation, in combination with a ratchet-type configuration, locks or secures the shutter 14 b in a desired orientation.
- the adapter key 20 b ( FIGS. 4A and 4B ) for the valve-type shutter 14 b includes a hollow needle 22 and first end 21 that serve similar purposes as those described in connection with the first embodiment of an adapter key 20 a.
- the second end 23 of the adapter key 20 b is more convex than concave and includes any number of unique interface elements, such as mating male 51 , 52 and female portions 54 and openings 56 .
- the interface elements enable the adapter key 20 b to mate or couple discretely with a valve-type shutter 14 b and/or with a patch pump device 30 that has an integrated valve-type shutter 14 b feature, so as to allow the valve-type shutter 14 b to be rotated within the patch pump device 30 , e.g., to align the fluid outlet path 59 with fluid channels leading to the reservoir 17 , only when the unique adapter key 20 b is used.
- the adapter key 20 b may also have locking tabs 55 for seeming a connection with the patch pump device 30 .
- locking tabs 55 may be used in combination with a bayonet connection 53 ( FIG. 7A ) formed in the patch pump device 30 .
- these locking tabs 55 may be frangible, so as to break away, e.g., within and while in contact with the bayonet connection 53 , after a first use to prevent reuse of the adapter key 20 b, e.g., by preventing, upon an attempted reuse, a seal for sufficiently pressurizing the medicament for filling the patch pump device 30 .
- FIGS. 5A and 5B An illustrative embodiment of a valve-type shutter 14 b, which may be manufactured from a metal, plastic, and the like, is shown in FIGS. 5A and 5B .
- the shutter 14 b includes a distal portion 60 , a proximal portion 62 , and a central portion 61 .
- the distal portion 60 includes, e.g., a cylindrical or substantially cylindrical nose 67 that is configured to fit snugly into a first recessed portion 10 in the patch pump device 30 to align the shutter 14 b and needle 22 properly and to provide an axis about which to rotate the medicament delivery system 40 .
- the proximal portion 62 includes a first opening 36 that is dimensioned for receiving, inter alia, a male portion 52 of the adapter key 20 b, e.g., in a tight, sliding fit, to provide an air- and fluid-tight seal.
- a plurality of tabs 57 , 58 may be formed on the outer surface of the proximal portion 62 .
- the longer tab 57 is configured to fit into a plurality of locations 71 , 73 , and 74 for the purposes described in detail below.
- the central portion 61 of the shutter 14 b includes a recessed portion 27 , which is adjacent to and coaxial with the first opening 36 and in fluid communication with a fluid outlet channel 59 , and an outer seal 64 , e.g., an elastomeric material, silicone, thermoplastic elastomer (TPE), and the like, that is disposed or formed about the periphery of the central portion 61 .
- the recessed portion 27 is dimensioned for receiving, inter alia, the needle 22 and for channeling or communicating medicament from the medicament container 35 into the fluid outlet channel 59 .
- the outer seal 64 which includes an opening 65 that surrounds the fluid outlet channel 59 , is adapted to fit snugly against a second recessed portion 34 in the patch pump system 30 to provide an air- and fluid-tight seal around the opening 65 during the filling operation.
- FIG. 5C shows a variation of the valve-type embodiment, in which the recessed portion 27 is adjacent to and coaxial with the first opening 36 and in fluid communication with multiple fluid outlet channels 59 a, 59 b .
- the shutter 14 b In use, when the shutter 14 b is in a closed configuration ( FIG. 7A ), a portion of the outer seal 64 other than the opening 65 is disposed between the fluid outlet channel 59 and a fluid port 63 in the patch pump system 30 to prevent premature delivery of the medicament into the patch pump system 30 .
- the opening 65 is disposed about and aligned with the fluid outlet channel 59 and the fluid port 63 , to provide a fluid path and an air- and fluid-tight seal at the fluid port 63 during the filling operation.
- FIGS. 7A-7E illustrate an embodiment of a method of filling the reservoir 17 of a patch pump system 30 using the medicament delivery system 40 having the adapter key 20 b and shutter 14 b described above.
- steps of attaching the adapter key 20 b to the medicament container 35 may be similar to those described above in connection with FIGS. 2A-2C and, moreover, that the steps of installing the medicament delivery system 40 on the patch pump system 30 may be similar to those described above in connection with FIG. 3A .
- Other attachment systems can alternatively be used, if desired.
- the adapter key 20 b may be inserted into an opening 66 in the patch pump system 30 and rotated, so that the locking tabs 55 engage the bayonet connection 53 formed in the patch pump system 30 at the opening 66 .
- FIGS. 6A, 7A and 7B shown the system in a closed position, which is to say, the longer tab 57 may be disposed at a first location 71 of the ratchet-type configuration 72 .
- the longer tab 57 prevents the medicament delivery system 40 from being rotated in a counter direction, e.g., counterclockwise, to the rotation direction, e.g., clockwise, used to lock the locking tabs 55 within the bayonet connection 53 .
- the outer seal 64 of the shutter 14 b may be positioned between the fluid outlet channel 59 and the fluid port 63 . Hence, no fluid path exists for communicating medicament into the reservoir 17 of the patch pump system 30 .
- the medicament delivery system 40 may be further rotated until the longer tab 57 reaches the second location 73 of the ratchet-type configuration 72 .
- the longer tab 57 reaches the second location 73
- the system is in an open position.
- the longer tab 57 again prevents the medicament delivery system 40 from being rotated in a counter direction.
- the fluid outlet channel 59 and the fluid port 63 are in fluid communication and the outer seal 64 of the shutter 14 b is positioned, such that opening 65 in the outer seal 64 is disposed about the fluid outlet channel 59 and the fluid port 63 , to provide an air- and fluid-tight connection.
- a fluid path is now open for transferring medicament from the medicament delivery system 40 into the reservoir 17 of the patch pump system 30 .
- the medicament delivery system 40 may be further rotated until the longer tab 57 reaches the third location 74 of the ratchet-type configuration 72 .
- the longer tab 57 reaches the third location 74
- the system again is in a closed position.
- the longer tab 57 again prevents the medicament delivery system 40 from being rotated in a counter direction.
- the outer seal 64 of the shutter 14 b is again positioned, such that outer seal 64 is disposed between the fluid channel 59 and the fluid port 35 .
- the fluid paths are closed to transferring medicament into the reservoir 17 of the patch pump system 30 .
- certain features e.g., the locking tabs 55 , may be frangible so as to break off after filling has been completed, e.g., through further twisting.
- the valve-type shutter 14 b may be reused and can be properly sanitized to remove any trace of the transferred medicament or contamination.
- the medicament delivery system 45 may include a syringe 95 as a medicament container instead of a pen, a vial, and/or a cartridge.
- the adapter key 20 c for use with a syringe 95 , includes a first portion 80 and a second portion 85 that are coaxially arranged with respect to each other, such that first portion 80 may displace co-axially and slidingly within the plenum 96 of the second portion 85 .
- the outer diameter of the first portion 80 may be slightly smaller than the inner diameter of the second portion 85 to facilitate the axial displacement.
- the first portion 80 of the adapter key 20 c may be configured receive and retain a syringe 95 , e.g., by axial pressing and/or twisting, while the second portion 85 of the adapter key 20 c may be adapted, first, to receive and retain a medicament vial 99 while filing the reservoir of the syringe 95 with a measured amount of a medicament and, subsequently, may he coupled to the patch pump device 30 , e.g., by axial pressing and/or twisting, for filling the reservoir 17 of the patch pump system 30 .
- the first portion 80 and a second portion 85 may be manufactured of metal, an elastomeric material, plastic, rubber, and the like.
- the first portion 80 may be cylindrical or substantially cylindrical in shape and may include an open first end 21 and a second end that is closed by a wall 84 , defining a plenum 82 within the wall 84 and the circumferential walls of the first portion 80 .
- the wall 84 includes an aperture through which a hollow needle 22 , extending into both the plenum 82 of the first portion 80 and the plenum 96 of the second portion 85 , is disposed.
- a reinforced area 83 is provided in the vicinity of a needle aperture to provide greater support to the cantilevered needle 22 and to ensure that the needle 22 remains centered and normal or substantially normal to the surface of the wall 84 .
- the wall 84 may disk-shaped and dimensioned to have a diameter that is slightly larger than the outer diameter of the first portion 80 to provide a shoulder 94 .
- the shoulder 94 of the first portion 80 is configured to abut an annular ring 97 of the second portion 85 and to support a cantilevered safety protrusion 88 , the purpose of which will be described in detail below.
- An alignment device 81 which is dimensioned to fit into a groove to track in the second portion 85 and structured and arranged to control the axial sliding of the first portion 80 with respect to the second portion 85 , may also be formed on the outer peripheral surface of the first portion 80 .
- the second portion 85 may be hollow and cylindrical or substantially cylindrical in shape, including an open first and second ends 23 , such that, once the first portion 80 of the adapter key 20 c has been properly inserted into the hollow second portion 85 , the wall 84 of the first portion 80 and the circumferential walls of the second portion 85 produce a plenum 96 within in the second portion 85 .
- a continuous, uninterrupted annular ring 97 may be formed about the entire circumference of the second portion 85 at the open first end. The outer diameter of the annular ring may be dimensioned to be flush with the outer peripheral surface of the circumferential wall of the second portion 85 .
- the thickness and inner diameter of the annular ring 97 are dimensioned to abut the shoulder 94 of the wall 84 of the first portion 80 , while allowing the circumferential wall of the first portion 80 to slidingly and axially translate within the plenum 96 of the second portion 85 .
- a groove or track that is dimensioned to receive the alignment device 81 formed on the outer, peripheral surface of the first portion 80 may be included in the annular ring 97 and/or the inner surficial wall of the second portion 85 .
- the groove or track and the alignment device 81 retain the concentric and coaxial first 80 and second portion 85 at a desired orientation with respect to each other during translation of the first portion 80 within the second portion 85 .
- the circumferential wall 106 of the second portion 85 includes a plurality of, e.g., two, locking tabs 86 and a first opening 104 , which is dimensioned to receive the safety protrusion 88 of the first portion 80 .
- the locking tabs 86 are cantilevered sections in the circumferential wall 106 of the second portion 85 and include keyed ends 90 .
- the cantilevered nature of the locking tabs 86 which allows the locking tabs 86 to displace, e.g., elastically, in a radial direction, is provided by forming axially-oriented slits 87 on either side of the locking tab 86 .
- the keyed ends 90 include a projection that protrudes radially inward of the locking tab 86 .
- the safety protrusion 88 is supported by the wall 84 of the first portion 80 and cantilevered to allow the protrusion 88 to displace, e.g., elastically, in a radial direction.
- the safety protrusion 88 includes a keyed end 89 that includes a projection that protrudes radially inward of the protrusion 88 .
- the second end 23 of the adapter key 20 c may include a rim 25 having a desired shaped and dimensions and on which a protrusion 26 is formed.
- the shape and dimension of the rim 25 can be selected to mate or couple with the opening 15 of the socket 13 on the user contact side 31 of the patch pump system 30 .
- the first end 21 and the first portion 80 of an adapter key 20 c may be structured and arranged to receive a syringe 95
- a second end 23 and the second portion 85 of the adapter key 20 c may be structured and arranged to receive a medicament vial 99 to fill the reservoir of the syringe 95 with a measured amount of a medicament, as well as to mate with the socket 13 of the patch pump system 30 to provide a lock and key type filling interface.
- access for filling the medicament reservoir or pump 17 of the patch pump system 30 is limited to individuals possessing the adapter key 20 c, the manufacture and distribution of which may be suitably controlled to prevent filling the patch pump system 30 with unauthorized or improper medicaments or by unauthorized individuals.
- the embodied keyed medicament delivery system 45 includes a syringe 95 that may be filled with a measured amount of insulin and the unique adapter key 20 c previously described.
- the unique adapter key 20 c initially provides a fluidic connection between the syringe 95 and a medicament vial 99 for the purpose of filling the syringe 95 with a measured amount of medicament and, subsequently, provides a fluidic connection between the syringe 95 and the socket 13 of the patch pump device 30 for the purpose of filling the reservoir 17 with the measured amount of a medicament.
- the hollow needle 22 extending axially in opposing directions about the wall 84 , may be contained within the adapter key 20 c and may be disposed within the plenums 82 , 96 of the first portion 80 and the second portion 85 to protect a user against inadvertent sticking.
- the first portion 80 and the second portion 85 of the adapter key 20 c may be movable with respect to each other, so that the first portion 80 , including the needle 22 and the safety protrusion 88 may translate axially within the plenum 96 of the second portion 85 .
- Such relative translation forces the hollow needle 22 through the septum 16 of the filling port 32 .
- the first portion 80 of the adapter key 20 c is adapted to mate or couple with a syringe 95 at a first end 92 thereof.
- the first end 92 of the syringe 95 includes a fitting 91 for releasably connecting, e.g., by tight sliding fit, with thread hags, and the like, the syringe 95 within the plenum 82 of the first portion 80 at the first end of 21 the adapter key 20 c.
- the coupling between the first portion 80 and the first end 92 of the syringe 95 provides an air- and fluid-tight seal, such that, when a syringe piston 93 is retracted from the reservoir of the syringe 95 , suction or a negative pressure is produced to draw a measured amount of medicament from a vial 99 through the needle 22 into the reservoir of the syringe 95 .
- the second portion 85 of the adapter key 20 c is adapted to mate or couple with a medicament vial 99 .
- the medicament vial 99 includes a fitting 98 for releasably connecting with the second portion 85 of the adapter key 20 c. More specifically, as shown in FIGS. 9D and 9E , as the second portion 85 of the adapter key 20 c is urged over the fitting 98 , the protrusions 90 of the locking tabs 86 and the protrusion 89 of the safety protrusion 88 are displaced radially outward away from the needle 22 until the protrusions 89 , 90 reach the end of the fitting 98 .
- the hollow needle 22 has established fluidic communication between the medicament vial 99 and the syringe 95 .
- the protrusions 89 , 90 have been allowed to return, e.g., elastically, at least partially toward their normal or original position.
- the protrusions 89 , 90 are able to engage and retain the rim of the fitting 98 during the syringe-filling operation.
- the syringe piston 93 may then be retracted from the reservoir of the syringe 95 , drawing a measured amount of medicament from the medicament vial 99 into the syringe reservoir.
- the medicament delivery system 45 is ready to fill the reservoir 17 of the patch pump system 30 and may be removed from the medicament vial 99 .
- the patch pump system 30 includes a guiding socket 13 , a key-lock filling port 32 , and a rotatable shutter 14 c that are integrated on or into the user contact side 31 of the patch pump system 30 .
- the socket 13 which may be disposed on the surface of the user contact side 31 , is provided as an initial guide for the adapter key 20 c.
- an opening 15 may be formed in the socket 13 and may be shaped and dimensioned to accommodate the outer peripheral surface and/or a rim 25 of the adapter key 20 c.
- the socket 13 may also include one or more elastic expansion elements 12 that are structured and arranged to displace radially when the adapter key 20 c is inserted into and rotated within the socket opening 15 and oriented to position the shutter 14 c in an open or uncovered state.
- the shutter 14 c is provided to cover and uncover a septum 16 that seals the reservoir or pump 17 .
- the shutter 14 c may be configured to include a rounded T-shape having a central portion 19 and two wing portions 18 .
- a central, elongate opening 11 adapted to receive a protrusion 26 of the adapter key 20 c and a pin 29 about which the shutter 14 c may rotate, may be provided in the central portion 19 of the shutter 14 c.
- the shutter 14 c is disposed beneath the user contact side 31 of the patch pump system 30 ( FIGS. 10A-10D ), such that the pin 29 is disposed within a distal end of the elongate opening 11 .
- the shutter 14 c is configured to rotate about the pin 29 upon application of a rotating force or torque to the protrusion 26 of the adapter key 20 c.
- the shutter 14 c has been described as having a rounded T-shape, those of ordinary skill in the art can appreciate that a myriad of, for example, rounded and polygonal shapes may be used to effect the purpose and function of the shutter 14 c.
- the shutter may be L-shaped, I-shaped, rectangular, triangular, and so forth.
- the key-lock filling port 32 includes an opening in the user contact side 31 of the patch pump system 30 and the septum 16 which may be pierced, e.g., by a hollow needle 22 , before the reservoir or pump 17 can be filled with a measured amount of medicament.
- the shutter 14 c covers and uncovers the filling port 32 , respectively, to protect the septum 16 from and to expose the septum 16 to the needle 22 of the adapter key 20 c.
- the patch pump system 30 may also include a receptacle 33 to provide another degree of security from improper medicament containers 45 .
- the receptacle 33 may be adapted to position the medicament delivery system 45 in a desired location before enabling delivery of a measured amount of medicament and, moreover, is dimensioned to receive a safety protrusion 88 that may be formed in the adapter key 20 c.
- the safety protrusion 88 and receptacle 33 are structured and arranged to mate or couple, so that, only when a proper medicament container 45 is being used can the safety protrusion 88 advance into the receptacle 33 , enabling the hollow needle 22 to penetrate the septum 16 .
- FIGS. 10A-10D illustrate an embodiment of a method of filling the reservoir 17 of a patch pump system 30 using the medicament delivery system 45 described above.
- the adapter key 20 c is inserted into the socket 13 of the patch pump system 30 .
- the shutter 14 c is in a closed position, hence, the septum 16 of the reservoir 17 is covered by one of the wings 18 of the T-shaped shutter 14 c.
- the syringe 95 and the patch pump system 30 are aligned for piercing the septum 16 and delivery of the medicament.
- Such alignment can be achieved, for example, by rotation of the syringe 95 and the adapter key 20 c within the socket 13 .
- the protrusion 26 on the rim 25 of the adapter key 20 c slides along the peripheral wall of the elongate opening 11 of the shutter 14 c, urging the T-shaped shutter 14 c, such that the proximal end of the elongate opening 11 is aligned with the filling port 32 and/or the septum 16 .
- Neither wing 18 of the shutter 14 c covers the port 32 or septum 16 .
- the socket 13 guides and controls the rotation and, advantageously, locks the adapter 20 c in place, e.g., using the elastic expansion elements 12 and/or a resilient decent, when in the proper position for filing the reservoir 17 .
- the syringe 95 and the patch pump system 30 the needle 22 and the septum 16 as well as the safety protrusion 88 and the receptacle 33 are properly aligned.
- the needle 22 can be advanced, e.g., axially, to the delivery position, piercing the septum 16 and allowing for the delivery of medicament to the reservoir 17 in the patch pump device 30 .
- the medicament delivery system 45 can be retracted, e.g., by twisting and lifting the syringe 95 , to remove and disengage the adapter 20 c and syringe 95 from the patch pump device 30 and to re-close the shutter 14 c.
- the syringe 95 and adapter 20 c are twisted past the shutter open position, to cover the port 32 and septum 16 with the second wing 18 of the shutter 14 c.
- the system could be rotated in the opposite direction to cover the port 32 and septum 16 with the first wing 18 .
- certain features, such as the safety protrusion 88 may be frangible so as to break off after filling has been completed, e.g., through twisting while the safety protrusion 88 is contained within the receptacle 33 to the second, re-closed position.
- FIGS. 11A through 12D A further variation to the adapter key 20 c and medicament delivery system 45 shown in FIGS. 8A through 9B is depicted in FIGS. 11A through 12D .
- Several of the components and their functional relationships are common to the embodiments of FIGS. 8A through 9B and FIGS. 11A through 12F , and may be used in a similar manner.
- One difference to the second portion 85 of the adapter key 20 d is the inclusion of a removable safety tab 110 that is structured and arranged to prevent premature deployment of the needle 22 and, thus, exposing the sharp end of the needle 22 while filling the syringe 95 from a medicament vial 99 .
- the removable safety tab 110 is formed on the outer, circumferential wall 106 of the second portion 85 of the adapter key 20 d, e.g., diametrically opposed to the aperture 104 .
- the safety tab 110 ( FIGS. 11A and 11B ) includes a paddle or grip portion 101 and plurality of, e.g., two, elongate legs 100 .
- the paddle portion 101 is perpendicularly or substantially perpendicularly attached to each of the elongate legs 100 at a juncture 102 to form an L shape.
- the elongate legs 100 are removably attached to the circumferential wall 106 of the second portion 85 of the adapter key 20 d and pivotable about corresponding weakened areas 103 in the second portion 85 .
- the elongate legs 100 which extend from the circumferential wall 106 of the second portion 85 , are configured to run axially along the peripheral surface of the first portion 80 of the adapter key 20 d. More particularly, the elongate legs 100 are axially (longitudinally) dimensioned such that when the first portion 80 of the adapter key 20 d is attached to the syringe 95 ( FIGS. 12A-12D ), the juncture 102 abuts the lip 105 of the syringe 95 .
- such an abutment retains the sharp end of the needle 22 within the plenum 96 of the second portion 85 , preventing exposing the needle 22 prematurely.
- the safety tab 110 prevents exposing the needle 22 , the abutment afforded by the safety tab 110 does not prevent or hinder the needle 22 from piercing the vial 99 septum or interfere with filling the syringe 95 with a measured amount of medicament.
- the tab 110 may be removed from the adapter key 20 d, e.g., by rotating the paddle portion 101 about the juncture 102 and/or by pulling the paddle portion 102 towards the weakened sections 103 . With some manual twisting and wiggling, the tab 110 should break away from the circumferential wall 106 of the second portion 85 of the adapter key 20 d. With the tab 110 removed, as previously describe in connection with FIGS.
- the adapter key 20 d which is now substantially the same as the adapter key 20 c, may be mated with or coupled to the socket 13 of the patch pump device 30 and longitudinal advancement of the needle 22 to pierce the septum 16 at the filling port 32 to the medicament delivery position is possible.
- FIGS. 13A through 16F Yet another illustrative embodiment of the present invention is depicted in FIGS. 13A through 16F .
- the patch pump system 30 ( FIGS. 15A and 15B ) includes a guiding cap 130 ( FIG. 13B ) that is integrated on or into the user contact side 31 of the patch pump system 30 and an arcuate shutter 14 e ( FIG. 13A ) that also is integrated on or into the patch pump system 30 .
- the arcuate shutter 14 e may be disposed beneath the user contact side 31 of the patch pump system 30 , so as to open and close the key-lock filling port 32 , respectively, to expose and cover the septum 16 to the reservoir 17 .
- a biasing system e.g., comprising one or more springs, may bias the arcuate shutter(s) 14 e toward the closed position ( FIG. 16A ). Accordingly, the shutter(s) 14 e would require a constant, greater opposing force to remain in the open position ( FIG. 16C ), which can be provided by the adapter key 20 e.
- the cap 130 ( FIG. 13B ), which may be disposed on or integrated into the surface of the user contact side 31 , is provided as an initial guide for the adapter key 20 e ( FIG. 13C ).
- the cap 130 e.g., made of a hard plastic and the like, may be shaped and dimensioned to accommodate a plurality of resilient tabs 48 that are formed on a second portion 150 of the adapter key 20 e.
- the cap 130 is hollow with a conical or frusto-conical shape that includes a plurality of raised portions 136 that project, e.g., in an axial direction, from a base portion 138 and a plurality of cut-out portions 137 that cut into the base portion 138 .
- the cut-out portion 137 and the raised portion 136 alternate about the periphery of the cap 130 .
- the cap 130 is being described as having a conical or frusto-conical shape, that is done for illustrative purposes only, as the cap 130 could assume any practical shape.
- the cap 130 includes a centrally located opening 139 that passes through the entire cap 130 and that enables the needle 22 to access the septum 16 , as will be described in greater detail below.
- Each of the cut-out portions 137 is dimensioned to receive and to accommodate a corresponding resilient tab 48 formed in the adapter key 20 e. More particularly, each of the cut-out portions 137 is configured to align with a corresponding opening 119 ( FIGS. 16C and 16E ) formed in the user contact side 31 of the patch pump system 30 .
- the openings 119 are adapted to position the medicament delivery system 45 in a desired location before delivering the measured amount of medicament.
- the medicament delivery system 45 includes a medicament container, e.g., a syringe 95 that can be filled with a measured amount of insulin, and an adapter key 20 e that is structured and arranged to mate or couple with the guide cap 130 and to provide a fluidic connection between the syringe 95 and a reservoir 17 in the patch pump device 30 , for the purpose of filling the reservoir 17 with a measured amount of a medicament.
- the adapter key 20 e includes a first portion 143 and a second portion 150 , which are separated by a wall 128 through which an aperture for a needle 22 is formed.
- a built-up portion 121 may be provided on at least one side of the aperture, e.g., on the first portion 143 side or the second portion 150 side of the wall 128 .
- the hollow needle 22 which is disposed in the aperture in the wall 128 and extends axially in opposing directions, may be surrounded by a plurality of resilient tabs 48 in the second portion 150 and by a circumferential wall 140 in the first portion 143 of the adapter key 20 e to protect a user against inadvertent sticking.
- the first portion 143 of the adapter key 20 e is structured and arranged to mate or couple with a medicament container, e.g., a syringe 95 , while filling the syringe 95 from a vial 99 and While delivering a measured amount of medicament to the reservoir 17 in the patch pump system 30 .
- the first portion 143 includes a circumferential wall 140 that, with the wall 128 , defines a plenum space in the first portion 143 .
- the plenum space and the circumferential wall 140 enable releasably connecting, e.g., by sliding fit, with threadings and the like, the adapter key 20 e to the syringe 95 .
- the second portion 150 of the adapter key 20 e is structured and arranged to mate or couple with a medicament container 99 , e.g., a medicament vial., for the purpose of filling the syringe 95 with a measured volume of medicament; to mate or couple with the guide cap 130 of the patch pump system 30 ; and to move the arcuate shutter(s) 14 e, so as to expose the septum 16 to the reservoir 17 to the needle 22 .
- rotation of the medicament delivery device 45 once it has been properly mated with the guide cap 130 on the patch pump system 30 , is not necessary.
- a special vial cap 41 ( FIG. 13D ) for connecting the medicament delivery system 45 to the medicament vial 99 is needed.
- the cap 41 resembles the guide cap 130 , while the other end includes a skirt 42 that is dimensioned to accommodate the syringe 95 .
- the vial cap 41 is hollow having, at the first end, a conical or frusto-conical shape that includes a plurality of raised portion 44 and a plurality of cut-out portions 46 that alternate about the periphery of the cap 130 .
- each of the cut-out portions 46 is dimensioned to receive and to accommodate a corresponding resilient tab 48 .
- one end of each cut-out portion 46 includes a wedge 141 that is structured and arranged to temporarily catch and hold, e.g., along a stop 142 , the locking tabs 49 formed on the end of each of the resilient tabs 48 .
- the resilient tabs 48 of the adapter key 20 e are aligned with the cut-out portions 46 of the vial cap 41 before the adapter key 20 e is urged in an axial direction towards the medicament vial 99 .
- the tabs 48 ride along the cut-out portions 46 , the tabs 48 are displaced radially outward, until the resilient tabs 48 reach the end of the wedge 141 , at which point the locking tabs 49 engage or abut the stop 142 .
- the needle 22 With the locking tabs 49 abutting the stop 142 , the needle 22 will have pierced the septum of the medicament vial 99 , to provide fluid communication between the medicament vial 99 and the syringe 95 .
- Refraction of the plunger 93 of the syringe 95 creates a suction or negative pressure, drawing a measured amount of the medicament into the syringe 95 .
- the arcuate shutter 14 e is provided to cover and uncover the septum 16 , which, respectively, interrupts and provides a fluid communication with the reservoir or pump 17 .
- the arcuate shutter 14 e may be configured to include an L-shaped end 132 at one, e.g., a distal, end; a U-shaped, e.g., proximal, end; and an arcuate central portion 131 therebetween.
- the U-shaped end includes a pair of legs 133 separated by an opening 134 .
- the shutter 14 e is disposed beneath the user contact side 31 of the patch pump system 30 , such that in an at rest state, the arcuate central portion 131 of the arcuate shutter 14 e is beneath the filling port 32 , covering the septum 16 .
- FIGS. 15A and 15B illustrate an embodiment of a method of mating or coupling a medicament delivery system 45 having adapter key 20 e with the guide cap 130 of a patch pump system 30
- FIGS. 16A through 16F illustrate an embodiment of a method of filling the reservoir 17 of the patch pump system 30 , using the medicament delivery system 45 having adapter key 20 e.
- the adapter key 20 e is inserted into the guide cap 130 of the patch pump system 30 , such that each of the resilient tabs 48 of the adapter key 20 e are aligned with a corresponding cut-out portion 137 in the guide cap 130 , as well as with the openings 119 in user contact surface 31 of the patch pump system 30 .
- FIGS. 16A and 16B when the adapter key 20 e is first inserted and properly mated in the guide cap 130 , one or more of the resilient tabs 48 is positioned above a corresponding opening 119 , as well as above the L-shaped end 132 of the arcuate shutter 14 e. In this position, the arcuate shutter 14 e is in a closed position, such that the central portion 131 of the arcuate shutter 14 e covers the septum 16 of the reservoir 17 . The needle 22 and the covered septum 16 are properly aligned for delivery of the medicament. In a second step ( FIGS.
- the medicament delivery system 45 may be urged further into the patch pump system 30 , such that each resilient tab 48 passes through a corresponding opening 119 and, at least one of the resilient tabs 48 contacts the L-shaped end 132 of the arcuate shutter 14 e. Further urging of the medicament delivery system 45 displaces the arcuate shutter 14 e to an open position, aligning the U-shaped opening 134 and the filling port 32 and exposing the septum 16 to the needle 22 .
- the needle 22 can be advanced, e.g., with further urging of the medicament delivery system 45 , to the delivery position in a next step ( FIGS. 16E and 16F ), that pierces the septum 16 and enables delivery of medicament into the reservoir 17 in the patch pump device 30 .
- the medicament delivery system 45 can be retracted, e.g., by lifting the syringe 95 , to remove and disengage the adapter 20 e from the guide cap 130 of the patch pump device 30 and to re-close the arcuate shutter 14 e.
- certain features e.g., the resilient tabs 48
- the resilient tabs 48 may be frangible so as to break off after filling has been completed, e.g., by twisting the medicament delivery system 45 to cause the resilient tabs 48 to break against the peripheral surface of openings 119 .
- FIGS. 17 through 19 an implementation of a self-contained medicament delivery system 170 is depicted in FIGS. 17 through 19 .
- the self-contained medicament delivery system 170 includes a unique adapter key 20 f that is disposed at an outlet 160 of the system 170 and adapted to mate or couple with the socket on the user contact side 31 of the patch pump system 30 .
- the adapter key 20 f and socket, as well as the corresponding shutter 14 f integrated into the patch pump system 30 may be of a type discussed hereinabove and, as a result will not be discussed in further detail.
- the medicament delivery system 170 ( FIG. 17 ) further includes a housing 171 , an inlet 174 , for receiving a medicament container, e.g., a medicament vial 99 ; an outlet 160 that includes a removable or replaceable adapter key 12 f; a latch 172 , for selectively coupling the medicament container 99 to a second needle 181 , and a pump actuation button 177 .
- the system 170 includes at least one conduit 180 , e.g., sterile tubing and the like, and a pump, e.g., a peristaltic pump, mechanism 165 for delivering a measured amount of a medicament, e.g., about 0.2 mL of insulin per actuation of the button 177 , into the reservoir 17 of the patch pump system 30 .
- a pump e.g., a peristaltic pump
- the conduit 180 is arranged in a serpentine configuration having a looped portion.
- the embodied pump mechanism 165 includes a gear-driven rotor 179 having a plurality of, e.g., three, rollers 189 disposed at the ends of a corresponding plurality of rotor arms, and an elongate rack 178 having a plurality of teeth. As shown in FIG. 18 , when a user presses down on the pump activation button 177 , e.g., using her thumb or other digit, the rack 178 translates linearly in the same direction as the applied force, causing the rotor 179 to rotate.
- a peristaltic pump 165 The operation of a peristaltic pump 165 is well known to those skilled in the art; accordingly, it will only be described briefly in the context of the present invention and use.
- a leading (in the direction of rotation) roller 189 pinches off a leading portion of the flexible, fluid-filled conduit 180 .
- a trailing roller 189 pinches off a second, trailing portion of the flexible, fluid-filled conduit 180 , confining or trapping a measured volume of the fluid, e.g., 2 mL, between the leading and trailing rollers 189 .
- leading and trailing rollers 189 continue to rotate with a measured volume of fluid trapped between therebetween. Once the leading roller 189 reaches a pre-determined location 166 , it no longer pinches the flexible, conduit 180 and the trailing roller 189 forces the fluid out of the conduit 180 and into the needle 22 and the reservoir 17 .
- Each pump event initiated by depressing the pump actuation button 177 delivers a pre-determined amount of medicament to the reservoir 17 , e.g., with about 0.2 mL of insulin.
- Needle-carrying fixtures 182 a, 182 b are removably attached at either end of the conduit 180 , e.g., to provide an air- and fluid-tight sliding fit with the conduit 180 .
- a first fixture 182 a is translatably disposed within the adapter key 20 f and configured, upon activation of the needle deployment device 173 , to introduce a needle through the filling port 32 and the septum 16 to provide a fluid communication to the reservoir 17 of the patch pump system 30 .
- a second fixture 182 b is disposed in the vicinity of the inlet 174 and latch 172 and configured, upon activation of the latch 172 , to urge the septum covering the medicament vial 99 around the needle 181 to provide a fluid communication.
- activation of the latch 172 causes the toggle 175 to rotate about a pin 188 , such that a distal tip 186 of the toggle 175 clears a shelf 176 that otherwise retains the distal tip 186 , preventing the medicament vial 99 from moving.
- the distal tip 186 of the toggle 175 clears a shelf 176 , the medicament container 99 is able to slide into contact with a second needle 181 .
- the filling pump device 170 is shipped attached to the patch pump device 30 , including sterile tubing connecting to the patch pump device 30 at the outlet 160 and to a medicament container 99 at the inlet 174 .
- a counter can also be included to keep track of the filling amount.
- the counter may count the number of rotations of the rotor 179 of the gear-driven peristaltic pump 165 , realizing that the volume of medicament contained within the sterile tubing, between the leading and trailing rollers 189 rotates, is substantially constant, e.g., 2 mL.
- one rotation of the rotor 179 would deliver three measured quantities of the medicament or 6 mL to the reservoir 17 of the patch pump device 30 .
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Abstract
A disposable patch pump may be provided with a filling adapter, to ensure filling by an authorized user. The adapter mates with the pump and a source of medicament, such as an insulin vial, to prevent filling the pump directly with a conventional syringe. The adapter and/or pump filling port may be configured with a frangible element, to limit the system to single use.
Description
- This application is a divisional of and claims priority to and the benefit of U.S. patent application Ser. No. 14/717,697, filed May 20, 2015, which claims priority to and the benefit of U.S. Provisional Patent Application No. 62/000,771, filed May 20, 2014, which are incorporated by reference herein in their entireties.
- The invention relates generally to wearable infusion pump devices (e.g., patch pumps) and other medical delivery devices having a filling port for filling the device with medicament and, more particularly, to systems and methods for preventing unauthorized filling of the device.
- Infusion devices (e.g., the infusion device described in U.S. Pat. No. 8,547,239, the contents of which are incorporated by reference as if set forth herein in their entirety) are often used to deliver medicament (e.g., insulin) to a user. With many insulin infusion devices, there is no physical restriction on the types of substances that can be used to fill the devices. Typically, an exposed septum on the device can be pierced by a hollow needle, allowing for the transfer of any substance that can move through the hollow needle into the device. This can lead to unintended uses and pose a risk to the user.
- It is therefore desirable to provide systems and methods to restrict access to a filling port of an infusion device, for safety and other reasons. An objective of the invention is to provide a lock and key type filling interface, in which the pump body includes one or more components forming a portion of the lock and an adapter forms corresponding mating key components. In this manner, access to fill the pump is limited to individuals possessing the adapter key, the manufacture and distribution of which may be suitably controlled. In one embodiment, a shutter and/or a valve may only be opened with the key, which key may have a specific mechanical shape, a specific distance between a needle and a coupling feature, and/or a specific length of the coupling feature. One or more components of the lock and key may be made sterile as necessary, and single use features may be incorporated in the pump and/or adapter components to preclude unauthorized reuse of single-use components.
- Another objective of the invention to prevent user error. One type of user error occurs when an incorrect type of medicament is used. By limiting delivery of the adapter with a specific type(s) of insulin, it is unlikely the adapter would be used with another, unauthorized medicament container. Another form of user error can occur through needle injury, such as “sticking” Certain features (e.g., the key) can be designed to protect against needle injury, such as by recessing the needle relative to another surface or covering the needle. User error may also occur when a user injects medicament into any other soft element (e.g., soft control buttons) on the patch pump device and not the filling port septum. Protecting the septum may make it difficult, if not impossible, to fill the device through any access other than the filling port, which filling port may only be accessed with the key. This configuration is especially useful in patch pumps and other medical delivery devices with a single port, although this configuration can also be used with multiple port pumps.
- Embodiments of insulin and other medicament infusion devices, such as disposable patch pumps that adhere to a patients skin include a restricted insulin filling port. In one embodiment, the filling port includes a movable cover mechanism (e.g., a shutter) that obstructs access to the filling port or a portion of the port, such as a needle piercing septum. The shutter can be automatically retracted to expose the septum when a unique adapter is mated with the filling port.
- Some embodiments have a sliding, rotating, or cantilevered shutter that is retracted, moved, or displaced with an adapter to provide access to the septum for filling the device with insulin. The adapter may uniquely interface with a housing of the device, so that the shutter may only be opened with a specific matching adapter, e.g., through a unique mating configuration or design. In some embodiments, the adapter is inserted into the patch pump base and rotated to shift or retract the shutter. A medicament container (e.g., a syringe, a pen, a cartridge, or a vial containing insulin or other medicament) may be coupled to the adapter and used to fill the patch pump. Embodiments of the system advantageously prevent filling of the patch pump directly with a conventional syringe.
- In one embodiment, the adapter is disposed at the end of an insulin delivery apparatus (or a medicament container) and provided with a standard 3 mL cartridge of insulin. To couple the medicament container to the device, the adapter is pushed into the pump base and rotated to open the shutter and expose the septum. The delivery apparatus is pushed further and then the cartridge is emptied into the pump reservoir. In another embodiment, the vehicle is preloaded with insulin instead of using a removable cartridge. In still another embodiment, the adapter may be used to secure a vial for withdrawing fluid into the delivery apparatus syringe, and the same adapter may be used to couple the device to the pump and fill the pump with insulin. In yet another embodiment, a vial may be coupled directly to the adapter which couples directly to the device. Various combinations of elements and kits can be delivered together, including pump(s), adapters, syringes, and medicament containers (e.g., vials, cartridges, pens, etc.).
- In one aspect, the invention relates to a patch pump system. The patch pump system has a patch pump device with a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position. The patch pump system also has a filling adapter adapted to be coupled to the filling port and move the shutter from the closed position to the open position.
- In one embodiment of the above aspect, the filling port has a septum. The filling port may be accessible from a user contact side of the patch pump device. In some embodiments, the shutter is accessible from a user contact side of the patch pump device. The shutter may be disposed within the patch pump device, and the shutter may be disposed within the filling port. The shutter can define a shutter opening, such that the shutter is in the open position when the shutter opening is aligned with a septum of the filling port. In some embodiments, the shutter is a valve or further includes a valve.
- In some embodiments of the above aspect, the patch pump device defines a device opening for coupling the filling adapter to the filling port and enabling controlled movement of the shutter. The filling adapter may have a mating surface adapted to fit in the device opening. The mating surface may have a protrusion and/or the mating surface may be adapted to contact the shutter. In certain embodiments, the filling adapter has a hollow needle. The needle may be exposed on two sides and be adapted to pierce two septa simultaneously. A first end of the filling adapter may be adapted to mate with a medicament container, which may be medicament container may be a syringe, a pen, a cartridge, and/or a vial. In some embodiments the patch pump system also has a socket adapted to receive the filling adapter, which socket may be adapted to support rotation of the filling adapter.
- In another aspect, the invention relates to a filling adapter for use with a patch pump device. The filling adapter has a first end adapted to mate with a medicament container and a second end adapted to couple to a filling port of a patch pump device and to move a shutter of the patch pump device from a closed position to an open position.
- In some embodiments of the above aspect, the first end defines a recess for receiving the medicament container. The first end may have a needle for piercing the medicament container. The medicament container may be a syringe, a pen, a cartridge, and/or a vial. The second end may have a needle. In certain embodiments, the second end has a protrusion adapted to extend into the patch pump device, such as a resilient tab. At least one of the first end and the second end may have a frangible component adapted to break after a single use.
- In another aspect, the invention relates to a method of filling a patch pump device. The method includes coupling a first end of a filling adapter to a medicament container, coupling a second end of the filling adapter to a filling port on a patch pump device to move a shutter proximate the filling port from a closed position preventing access to the filing port to an open position allowing access to the filling port, and filling a reservoir of the patch pump device with medicament from the medicament container via the filling port.
- In some embodiments of the above aspect, coupling the first end of the filling adapter to the medicament container includes receiving at least a portion of the medicament container in a recess of the filling adapter. Coupling the first end of the filling adapter to the medicament container may include piercing the medicament container with a needle. Coupling the second end of the filling adapter to the filling port on the patch pump device may include inserting a mating surface of the second end into the patch pump device, and may include rotating the filling adapter to move the shutter. In certain embodiments, the inserting step moves the shutter to the open position. The medicament container may be a syringe, a pen, a cartridge, and/or a vial. Filling the reservoir can include transferring medicament from the medicament container under pressure. The method may also include, after coupling the first end of the filling adapter to the medicament container, drawing medicament into the medicament container. The medicament may be drawn from a vial coupled to the second end.
- In another aspect, the invention relates to a patch pump device. The patch pump device has a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port when in the closed position, wherein the shutter comprises at least one mating surface adapted to couple to a filling adapter to move the shutter to the open position.
- In another aspect, the invention relates to a filling system adapted for use with a patch pump device. The filling system includes a filling adapter having a first end adapted to receive a medicament container and a second end adapted to mate with a filling port of a patch pump device and move a shutter of the patch pump device from a closed position to an open position. The filling system also includes a medicament container.
- In another aspect, the invention relates to a patch pump kit. The patch pump kit includes a patch pump device with a filling port and a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port when in the closed position. The patch pump kit also includes a filling adapter with a first end adapted to receive a medicament container and a second end adapted to mate with the filling port and move from the closed position to the open position. The patch pump kit also includes a medicament container.
- In another aspect, the invention relates to a filling adapter kit. The filling adapter kit includes a medicament container adapter, a syringe adapter, and a pump device filling port adapter.
- In some embodiments of the above aspect, at least a portion of the syringe adapter is adapted to actuate a shutter disposed in a pump device to move the shutter from a closed position to an open position.
- In another aspect, the invention relates to a patch pump kit. The patch pump kit includes a patch pump device with a filling port and a shutter movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position. The patch pump kit also includes a filling pump device adapted to mate with the filling port and move the shutter to the open position. The filling pump device includes an inlet for receiving a medicament container, an outlet for mating with the filling port, and a pump for transferring medicament from the inlet to the outlet. The patch pump kit also includes an adapter for mating the medicament container to the inlet.
- In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:
-
FIG. 1A shows a perspective view of an illustrative embodiment of an adapter key in accordance with the present invention; -
FIG. 1B shows a cross-sectional view of the adapter key ofFIG. 1A in accordance with some embodiments of the present invention; -
FIG. 1C shows a perspective view of an illustrative embodiment of a socket in accordance with the present invention; -
FIG. 1D shows a top view of an illustrative embodiment of a shutter in accordance with the present invention; -
FIG. 2A shows a cross-sectional view of the adapter key ofFIG. 1A coupled to a medicament container in accordance with some embodiments of the present invention; -
FIGS. 2B and 2C show perspective views of a medicament delivery system with the adapter key ofFIG. 1A in accordance with some embodiments of the present invention; -
FIG. 3A shows a perspective view of a medicament delivery system coupled to a patch pump system in accordance with some embodiments of the present invention; -
FIG. 3B shows a bottom view of the coupled medicament delivery system ofFIG. 3A in which the shutter is in a first closed position in accordance with some embodiments of the present invention; -
FIG. 3C shows a cross-sectional detail of the coupled medicament delivery system ofFIG. 3A in which the shutter is in an open position in accordance with some embodiments of the present invention; -
FIG. 3D shows a bottom view of the coupled medicament delivery system ofFIG. 3A in which the shutter is in the open position in accordance with some embodiments of the present invention; -
FIG. 3E shows cross-sectional detail of the coupled medicament delivery system ofFIG. 3A in which the shutter is in the open position in accordance with some embodiments of the present invention and the needle has pierced a septum fluidically coupled to a reservoir in the patch pump system in accordance with some embodiments of the present invention; -
FIG. 3F shows a cross-sectional detail of the coupled medicament delivery system ofFIG. 3A in which the needle has been retracted and the shutter has been re-closed to a second position in accordance with some embodiments of the present invention; -
FIG. 3G shows a bottom view of the medicament delivery system and patch pump system ofFIG. 3A with the shutter re-closed to the second position in accordance with some embodiments of the present invention; -
FIGS. 4A and 4B show perspective views of a second adapter key in accordance with some embodiments of the present invention; -
FIG. 5A shows a perspective views of an illustrative embodiment of a valve-type shutter for use with the adapter key ofFIGS. 4A and 4B in accordance with the present invention; -
FIG. 5B shows a cross-sectional view of the valve-type shutter ofFIG. 5A in accordance with the present invention; -
FIG. 5C shows a cross-sectional view of an embodiment of a valve-type shutter having two fluid outlet paths in an open state for use with the adapter key ofFIGS. 4A and 4B in accordance with the present invention; -
FIG. 6A shows a bottom perspective view of the valve-type shutter disposed at a first location within a ratchet-type system within the patch pump system for use with the adapter key ofFIGS. 4A and 4B in accordance with some embodiments of the present invention; -
FIG. 6B shows a bottom perspective view of the valve-type shutter disposed at a second location within the ratchet-type system within the patch pump system for use with the adapter key ofFIGS. 4A and 4B in accordance with some embodiments of the present invention; -
FIG. 7A shows a cross-sectional view of the second adapter key ofFIGS. 4A and 4B mounted in the valve-type shutter ofFIGS. 5A and 5B in a dosed position in accordance with some embodiments of the present invention; -
FIG. 7B shows a bottom view of the coupled valve-type shutter and adapter key ofFIG. 7A with a resilient tab disposed at a first location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention; -
FIG. 7C shows a cross-sectional view of the second adapter key ofFIGS. 4A and 4B mounted in the valve-type shutter ofFIGS. 5A and 5B in an open position accordance with some embodiments of the present invention; -
FIG. 7D shows a bottom view of the coupled valve-type shutter and adapter key ofFIG. 7C with a resilient tab disposed at a second location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention; -
FIG. 7E shows a bottom view of the coupled valve-type shutter and adapter key ofFIG. 7A with a resilient tab disposed at a third location within a ratchet-type system of the patch pump system in accordance with some embodiments of the present invention; -
FIG. 8A shows a perspective view of an adapter key for use with a syringe in accordance with some embodiments of the present invention; -
FIG. 8B shows a cross-sectional view of the adapter key ofFIG. 8A in accordance with some embodiments of the present invention; -
FIGS. 9A and 9B show perspective views of an illustrative embodiment of a syringe-type medicament delivery system having the adapter key ofFIG. 8A in accordance with the present invention; -
FIGS. 9C and 9D show perspective views of the syringe-type medicament delivery system ofFIGS. 9A and 9B and a medicament vial in accordance with the present invention; -
FIG. 9E shows a cross-sectional view of the adapter key ofFIG. 8A coupled to a medicament vial ofFIG. 9D in accordance with some embodiments of the present invention; -
FIG. 10A shows a cross-sectional detail of the medicament delivery system ofFIG. 9B and patch pump system with a closed shutter in accordance with some embodiments of the present invention; -
FIG. 10B shows a cross-sectional detail of the medicament delivery system ofFIG. 9B and patch pump system with an open shutter in accordance with some embodiments of the present invention; -
FIG. 10C shows a cross-sectional detail of the medicament delivery system ofFIG. 9B in which the needle has pierced the septum of the patch pump system in accordance with some embodiments of the present invention; -
FIG. 10D shows a cross-sectional detail of the medicament delivery system ofFIG. 9B and patch pump system in which the shutter is re-closed in accordance with some embodiments of the present invention; -
FIG. 11A shows a perspective view of an adapter key with a safety tab for use with a syringe in accordance with some embodiments of the present invention; -
FIG. 11B shows a cross-sectional view of the adapter key ofFIG. 11A in accordance with some embodiments of the present invention; -
FIGS. 12A and 12B show perspective views of an illustrative embodiment of a syringe-type medicament delivery system having the adapter key ofFIG. 11A in accordance with the present invention; -
FIG. 12C shows a perspective view of the safety-tabbed syringe-type medicament delivery system ofFIGS. 11A and 11B and a medicament vial in accordance with the present invention; -
FIG. 12D shows a cross-sectional view of the safety-tabbed adapter key ofFIG. 11A coupled to a medicament vial in accordance with some embodiments of the present invention; -
FIG. 13A shows a perspective view of an arcuate shutter for use with another medicament delivery system in accordance with some embodiments of the present invention; -
FIG. 13B shows a perspective view of a socket in accordance with some embodiments of the present invention; -
FIG. 13C shows a perspective view of an adapter key for use with another medicament delivery system in accordance with some embodiments of the present invention; -
FIG. 13D shows a perspective view of a cap for a medicament vial for use with another medicament delivery system in accordance with some embodiments of the present invention; -
FIG. 14a shows a perspective view of a medicament delivery system with the adapter key ofFIG. 13C in accordance with some embodiments of the present invention; -
FIG. 14b shows a perspective view of the medicament delivery system ofFIG. 14a coupled to a medicament vial in accordance with some embodiments of the present invention; -
FIG. 14C shows a cross-sectional view of the adapter key ofFIG. 13C coupled to a medicament vial in accordance with some embodiments of the present invention; -
FIG. 15A shows a perspective view of the medicament delivery system ofFIG. 14a aligned over the socket of a patch pump system in accordance with some embodiments of the present invention; -
FIG. 15B shows a perspective view of the medicament delivery system of 14 a coupled with the socket of a patch pump system in accordance with some embodiments of the present invention; -
FIG. 16A shows a cross-sectional detail of the coupled medicament delivery system ofFIG. 15B with the arcuate shutter in a closed position in accordance with some embodiments of the present invention; -
FIG. 16B shows a bottom view of the coupled shutter and adapter key ofFIG. 16A in accordance with some embodiments of the present invention; -
FIG. 16C shows cross-sectional detail of the coupled medicament delivery system ofFIG. 15B with the arcuate shutter in an open position in accordance with some embodiments of the present invention; -
FIG. 16D shows a bottom view of the coupled shutter and adapter key ofFIG. 16C in accordance with some embodiments of the present invention; -
FIG. 16E shows cross-sectional detail of the coupled medicament delivery system ofFIG. 15B with the hollow needle piercing the septum of the patch pump system in accordance with some embodiments of the present invention; -
FIG. 16F shows a bottom view of the coupled shutter and adapter key ofFIG. 16E in accordance with some embodiments of the present invention; -
FIG. 17 shows a perspective view of a contained medicament delivery system coupled with a patch pump system in accordance with some embodiments of the present invention; -
FIG. 18 shows a cross-sectional view of the coupled medicament delivery system ofFIG. 17 in a closed position and having a medicament vial attached in accordance with some embodiments of the present invention; and -
FIG. 19 shows a cross-sectional detail of an activating pin of the contained medicament delivery system ofFIG. 17 in accordance with some embodiments of the present invention. - A
patch pump system 30 and uniquely-keyedmedicament delivery system 40 in accordance with one embodiment of the present invention are depicted inFIGS. 1A-3G . Advantageously, thepatch pump system 30 and keyedmedicament delivery system 40 are structured and arranged to mate or couple with a guidingsocket 13 to provide a lock-and-key-type filling interface. In this manner, access for filling a medicament reservoir or pump 17 of thepatch pump system 30 is limited to individuals possessing the filling adapter or adapter key 20 a, the manufacture and distribution of which may be suitably controlled to prevent coupling with and/or filling thepatch pump system 30 using unauthorized or improper medicaments, or by unauthorized individuals. - In some implementations of the embodiment, the
patch pump system 30 includes a guidingsocket 13, a key-lock filling port 32, and a movable, e.g., rotatable, shutter 14 a that are integrated on or into theuser contact side 31 of thepatch pump system 30. Thesocket 13, which may be disposed on the surface of theuser contact side 31, is provided as an initial guide for the adapter key 20 a. For example, thesocket 13 may define anopening 15 and may be shaped and dimensioned to accommodate the outer peripheral surface and/or arim 25 of the adapter key 20 a. In some variations, thesocket 13 may also include one or moreelastic expansion elements 12 that are structured and arranged to displace radially when the adapter key 20 a is inserted into and rotated within thesocket opening 15 and oriented to position theshutter 14 a in an open (uncovered) state. - The
shutter 14 a may be configured to cover and uncover aseptum 16 that seals the reservoir or pump 17. As shown inFIG. 1D , theshutter 14 a may have a rounded T-shape having acentral portion 19 and twowing portions 18. A central,elongate opening 11 adapted to receive aprotrusion 26 of the adapter key 20 a and apin 29 about which theshutter 14 a may rotate, may be provided in thecentral portion 19 of theshutter 14 a. In some implementations, theshutter 14 a is disposed beneath theuser contact side 31 of the patch pump system 30 (FIG. 3B ), such that thepin 29 is disposed within a distal end of theelongate opening 11. In operation, theshutter 14 a is configured to rotate about thepin 29 upon application of a rotating force or torque to theprotrusion 26 of the adapter key 20 a. Although theshutter 14 a has been described as having a rounded T-shape, those of ordinary skill in the art can appreciate that a myriad of, for example, rounded and polygonal shapes may be used to effect the purpose and function of theshutter 14 a. For example, the shutter may be L-shaped, I-shaped, rectangular, triangular, and so forth. - The key-
lock filling port 32 includes an opening in theuser contact side 31 of thepatch pump system 30 and theseptum 16, which may be pierced, e.g., by ahollow needle 22, before the reservoir or pump 17 can be filled with a measured amount of medicament. Theshutter 14 a covers and uncovers the fillingport 32, respectively, to protect theseptum 16 from and to expose theseptum 16 to theneedle 22 of the adapter key 20 a in addition to theshutter 14 a, thepatch pump system 30 may also include areceptacle 33 to provide another degree of security fromimproper medicament containers 35. For example, thereceptacle 33 may be adapted to position themedicament delivery system 35 in a desired location before enabling delivery of a measured amount of medicament and, moreover, may be dimensioned to receive asafety protrusion 24 that may be formed in the adapter key 20 a. Advantageously, thesafety protrusion 24 andreceptacle 33 are structured and arranged to mate or couple, so that, only when aproper medicament container 35 is being used can thesafety protrusion 24 advance into thereceptacle 33, enabling thehollow needle 22 to penetrate theseptum 16. - As shown in
FIGS. 2A-2C , the keyedmedicament delivery system 40 includes amedicament container 35, e.g., a pen and/or a cartridge pre-filled with a measured amount of insulin, and an adapter key 20 a that provides a fluidic connection between themedicament container 35 and areservoir 17 in thepatch pump device 30, e.g., for the purpose of filling thereservoir 17 with a measured amount of a medicament. As shown inFIGS. 1A and 1B , in some implementations, the adapter key 20 a includes afirst end 21 and asecond end 23, each of which includes a hollow, cylindrical or substantially cylindrical portion. The hollow portions of the first end 21andsecond end 23 are separated by awall 28 through which ahollow needle 22 passes. To protect a user against inadvertently sticking the user or another, thehollow needle 22 may be contained or recessed within the adapter key 20 a or, more particularly, within the hollow portions at the first 21 and second ends 23 of the adapter key 20 a. - The
first end 21 and thesecond end 23 of the adapter key 20 a may be movable with respect to each other, such that themedicament container 35 can be urged to force thehollow needle 22 through theseptum 16 of the fillingport 32, e.g., by sliding, e.g., in an axial direction, the first end 21of the adapter key 20 a relative to thesecond end 23 of the adapter key 20 a. Thefirst end 21 may include a raised,alignment device 111 formed on the outer, peripheral surface of thefirst end 21. Thealignment device 111 can be structured and arranged to mate or couple with a receiving groove or track defined by the inner surface of thesecond end 23. The groove or track may be dimensioned to receive thealignment device 111. Thealignment device 111 and groove combination position and guide thefirst end 21 with respect to thesecond end 23 while thefirst end 21 slidingly translates into and within thesecond end 23 during the septum piercing process and medicament delivery. Thefirst end 21 of the adapter key 20 a is further configured to receive and to pierce a septum or seal 37 of the medicament container, e.g., by axial pressing and/or twisting, while thesecond end 23 of the adapter key 20 a may be coupled to thesocket 13 of thepatch pump device 30. - As shown in
FIGS. 2A-2C , thefirst end 21 is adapted to mate with amedicament container 35 at afirst end 39 thereof. In some variations, thefirst end 39 of themedicament container 35 includes a fitting 38 for releasably connecting, e.g., by close sliding fit, with threadings, or the like, themedicament container 35 to the first end of 21 the adapter key 20 a. When the adapter key 20 a is properly attached to themedicament container 35, thehollow needle 22 of the adapter key 20 a is located to pierce theseptum 37 of themedicament container 35, during attachment. Referring also toFIG. 1B , thefirst end 21 of the adapter key 20 a may also include an additional safety feature, e.g., asafety protrusion 24, that is cantilevered axially from thewall 28. Thesafety protrusion 24 is configured to prevent the premature deployment of theneedle 22, e.g., until the fillingport shutter 14 a is opened and theneedle 22 and theseptum 16 are properly aligned. Once mated in areceptacle 33 in thepatch pump system 30, thesafety protrusion 24 aligns with the receptacle 33 (FIG. 3C ) to enable advancement of theneedle 22 into and through theseptum 16. - Referring to
FIG. 1A , in some variations, thesecond end 23 of the adapter key 20 a may include arim 25 having a desired shaped and dimensions and on which aprotrusion 26 is formed. Advantageously, the shape and dimension of therim 25 can be selected to mate with theopening 15 of thesocket 13 on theuser contact side 31 of thepatch pump system 30. -
FIGS. 3A-3G illustrate an embodiment of a method of filling thereservoir 17 of apatch pump system 30 using themedicament delivery system 40 described above. In a first step (FIGS. 3A and 3B ), the adapter key 20 a is inserted into thesocket 13 of thepatch pump system 30. As shown inFIG. 3B , when the adapter key 20 a is first inserted, theshutter 14 a is in a closed position, hence, theseptum 16 of thereservoir 17 is covered by one of thewings 18 of the T-shapedshutter 14 a. In a second step (FIGS. 3C and 3D ), themedicament container 35 and thepatch pump system 30 and, more specifically, theneedle 22 is aligned with theseptum 16, in preparation for piercing theseptum 16 and for delivery of the medicament. Such alignment can be achieved, for example, by rotation of themedicament container 35 and the adapter key 20 a within thesocket 13. During rotation, theprotrusion 26 on therim 25 of the adapter key 20 a slides along the peripheral wall of theelongate opening 11 of theshutter 14 a, urging theshutter 14 a such that the proximal end of theelongate opening 11 is aligned with the fillingport 32 and theseptum 16. Neitherwing 18 of theshutter 14 a covers theport 32 orseptum 16. In one variation, thesocket 13 guides and controls rotation and, advantageously, locks theadapter 20 a in place. e.g., using theelastic expansion elements 12 and/or a resilient detent, when in the proper position for piercing theseptum 16 and for filling thereservoir 17. - With the
shutter 14 a in an open state (FIG. 3E ), in a next step, with thesafety protrusion 24 on thefirst end 21 also aligned with thereceptacle 33, thefirst end 21, slides in an axial direction within thesecond end 23. Theneedle 22 is advanced to the delivery position, piercing theseptum 16 and allowing for the delivery of medicament to thereservoir 17 in thepatch pump device 30. Once thereservoir 17 has been filled with a measured amount of the medicament, themedicament delivery system 40 can be retracted, e.g., by twisting and lifting the medicament container 35 (FIGS. 3F and 3G ), to remove and disengage theadapter 20 a andmedicament container 35 from thepatch pump device 30 and to re-close theshutter 14 a. As depicted, thecontainer 35 andadapter 20 a are twisted past the shutter open position, to cover theport 32 andseptum 16 with the second lobe orwing 18 of theshutter 14 a. Alternatively, thesystem 10 could be rotated in the opposite direction to cover theport 32 andseptum 16 with the first lobe orwing 18 of theshutter 14 a. Advantageously, to prevent additional uses of theadapter 20 a, in some variations, certain features, such as thesafety protrusion 24, may be frangible so as to break off after filling has been completed, e.g., through twisting while thesafety protrusion 24 is contained within thereceptacle 33 to the second, re-closed position. - In another embodiment, depicted in
FIGS. 4A-7E , amedicament container 35, e.g., a pen, a cartridge, and/or a vial, can be coupled to afirst end 21 of a second embodiment of an unique adapter key 20 b, which is adapted to receive themedicament container 35, while asecond end 23 of the unique adapter key 20 b is adapted to mate or couple to apatch pump device 30 via a valve-type shutter 14 b. In this embodiment, theshutter 14 b may be a valve that is axially rotatable to open or close a fluid path between theneedle 22 and thereservoir 17 of thepatch pump device 30 when theadapter key 20 b and shutter 14 b properly aligned. In some implementations, theshutter 14 b may have one or moreresilient tabs patch pump device 30 having a surrounding ratchet-type configuration 72 (FIGS. 5A, 6A, and 6B ). As a result, rotation of theshutter 14 b may occur in only one direction, e.g. clockwise, and such rotation, in combination with a ratchet-type configuration, locks or secures theshutter 14 b in a desired orientation. - The
adapter key 20 b (FIGS. 4A and 4B ) for the valve-type shutter 14 b includes ahollow needle 22 andfirst end 21 that serve similar purposes as those described in connection with the first embodiment of an adapter key 20 a. In contrast to the first embodiment, thesecond end 23 of theadapter key 20 b is more convex than concave and includes any number of unique interface elements, such asmating male female portions 54 andopenings 56. The interface elements enable theadapter key 20 b to mate or couple discretely with a valve-type shutter 14 b and/or with apatch pump device 30 that has an integrated valve-type shutter 14 b feature, so as to allow the valve-type shutter 14 b to be rotated within thepatch pump device 30, e.g., to align thefluid outlet path 59 with fluid channels leading to thereservoir 17, only when the unique adapter key 20 b is used. Theadapter key 20 b may also have lockingtabs 55 for seeming a connection with thepatch pump device 30. For example, lockingtabs 55 may be used in combination with a bayonet connection 53 (FIG. 7A ) formed in thepatch pump device 30. Advantageously, these lockingtabs 55 may be frangible, so as to break away, e.g., within and while in contact with thebayonet connection 53, after a first use to prevent reuse of theadapter key 20 b, e.g., by preventing, upon an attempted reuse, a seal for sufficiently pressurizing the medicament for filling thepatch pump device 30. - An illustrative embodiment of a valve-
type shutter 14 b, which may be manufactured from a metal, plastic, and the like, is shown inFIGS. 5A and 5B . Theshutter 14 b includes adistal portion 60, aproximal portion 62, and acentral portion 61. Thedistal portion 60 includes, e.g., a cylindrical or substantiallycylindrical nose 67 that is configured to fit snugly into a first recessedportion 10 in thepatch pump device 30 to align theshutter 14 b andneedle 22 properly and to provide an axis about which to rotate themedicament delivery system 40. Theproximal portion 62 includes afirst opening 36 that is dimensioned for receiving, inter alia, amale portion 52 of theadapter key 20 b, e.g., in a tight, sliding fit, to provide an air- and fluid-tight seal. A plurality oftabs proximal portion 62. Thelonger tab 57 is configured to fit into a plurality oflocations - The
central portion 61 of theshutter 14 b includes a recessedportion 27, which is adjacent to and coaxial with thefirst opening 36 and in fluid communication with afluid outlet channel 59, and anouter seal 64, e.g., an elastomeric material, silicone, thermoplastic elastomer (TPE), and the like, that is disposed or formed about the periphery of thecentral portion 61. The recessedportion 27 is dimensioned for receiving, inter alia, theneedle 22 and for channeling or communicating medicament from themedicament container 35 into thefluid outlet channel 59. Theouter seal 64, which includes anopening 65 that surrounds thefluid outlet channel 59, is adapted to fit snugly against a second recessedportion 34 in thepatch pump system 30 to provide an air- and fluid-tight seal around theopening 65 during the filling operation.FIG. 5C shows a variation of the valve-type embodiment, in which the recessedportion 27 is adjacent to and coaxial with thefirst opening 36 and in fluid communication with multiplefluid outlet channels - In use, when the
shutter 14 b is in a closed configuration (FIG. 7A ), a portion of theouter seal 64 other than theopening 65 is disposed between thefluid outlet channel 59 and afluid port 63 in thepatch pump system 30 to prevent premature delivery of the medicament into thepatch pump system 30. When theshutter 14 b is in an open configuration (FIG. 7C ), theopening 65 is disposed about and aligned with thefluid outlet channel 59 and thefluid port 63, to provide a fluid path and an air- and fluid-tight seal at thefluid port 63 during the filling operation. -
FIGS. 7A-7E illustrate an embodiment of a method of filling thereservoir 17 of apatch pump system 30 using themedicament delivery system 40 having theadapter key 20 b and shutter 14 b described above. Those of ordinary skill in the art can appreciate that the steps of attaching theadapter key 20 b to themedicament container 35 may be similar to those described above in connection withFIGS. 2A-2C and, moreover, that the steps of installing themedicament delivery system 40 on thepatch pump system 30 may be similar to those described above in connection withFIG. 3A . Other attachment systems can alternatively be used, if desired. Once theadapter key 20 b andmedicament container 35 have been joined to create a fluid communication between theneedle 22 and themedicament container 35, in a first step (FIGS. 7A and 7B ), theadapter key 20 b may be inserted into anopening 66 in thepatch pump system 30 and rotated, so that the lockingtabs 55 engage thebayonet connection 53 formed in thepatch pump system 30 at theopening 66.FIGS. 6A, 7A and 7B shown the system in a closed position, which is to say, thelonger tab 57 may be disposed at afirst location 71 of the ratchet-type configuration 72. At thefirst location 71, thelonger tab 57 prevents themedicament delivery system 40 from being rotated in a counter direction, e.g., counterclockwise, to the rotation direction, e.g., clockwise, used to lock thelocking tabs 55 within thebayonet connection 53. In this state, theouter seal 64 of theshutter 14 b may be positioned between thefluid outlet channel 59 and thefluid port 63. Hence, no fluid path exists for communicating medicament into thereservoir 17 of thepatch pump system 30. - In a next step (
FIGS. 7C and 7D ), themedicament delivery system 40 may be further rotated until thelonger tab 57 reaches thesecond location 73 of the ratchet-type configuration 72. When thelonger tab 57 reaches thesecond location 73, the system is in an open position. At thesecond location 73, thelonger tab 57 again prevents themedicament delivery system 40 from being rotated in a counter direction. In the open position, thefluid outlet channel 59 and thefluid port 63 are in fluid communication and theouter seal 64 of theshutter 14 b is positioned, such thatopening 65 in theouter seal 64 is disposed about thefluid outlet channel 59 and thefluid port 63, to provide an air- and fluid-tight connection. Thus, a fluid path is now open for transferring medicament from themedicament delivery system 40 into thereservoir 17 of thepatch pump system 30. - Finally, in a next step (
FIGS. 6B, 7A, and 7E ), themedicament delivery system 40 may be further rotated until thelonger tab 57 reaches thethird location 74 of the ratchet-type configuration 72. When thelonger tab 57 reaches thethird location 74, the system again is in a closed position. At thethird location 74, thelonger tab 57 again prevents themedicament delivery system 40 from being rotated in a counter direction. Moreover, theouter seal 64 of theshutter 14 b is again positioned, such thatouter seal 64 is disposed between thefluid channel 59 and thefluid port 35. Hence, the fluid paths are closed to transferring medicament into thereservoir 17 of thepatch pump system 30. - Advantageously, to prevent multiple uses of the
adapter 20 b, in some variations, certain features, e.g., the lockingtabs 55, may be frangible so as to break off after filling has been completed, e.g., through further twisting. The valve-type shutter 14 b, however, may be reused and can be properly sanitized to remove any trace of the transferred medicament or contamination. - In yet another embodiment, the
medicament delivery system 45 may include asyringe 95 as a medicament container instead of a pen, a vial, and/or a cartridge. Referring toFIGS. 8A and 8B , in some implementations, for use with asyringe 95, theadapter key 20 c includes afirst portion 80 and asecond portion 85 that are coaxially arranged with respect to each other, such thatfirst portion 80 may displace co-axially and slidingly within theplenum 96 of thesecond portion 85. Hence, the outer diameter of thefirst portion 80 may be slightly smaller than the inner diameter of thesecond portion 85 to facilitate the axial displacement. Thefirst portion 80 of theadapter key 20 c may be configured receive and retain asyringe 95, e.g., by axial pressing and/or twisting, while thesecond portion 85 of theadapter key 20 c may be adapted, first, to receive and retain amedicament vial 99 while filing the reservoir of thesyringe 95 with a measured amount of a medicament and, subsequently, may he coupled to thepatch pump device 30, e.g., by axial pressing and/or twisting, for filling thereservoir 17 of thepatch pump system 30. Thefirst portion 80 and asecond portion 85 may be manufactured of metal, an elastomeric material, plastic, rubber, and the like. - The
first portion 80 may be cylindrical or substantially cylindrical in shape and may include an openfirst end 21 and a second end that is closed by a wall 84, defining a plenum 82 within the wall 84 and the circumferential walls of thefirst portion 80. The wall 84 includes an aperture through which ahollow needle 22, extending into both the plenum 82 of thefirst portion 80 and theplenum 96 of thesecond portion 85, is disposed. In some variations, a reinforcedarea 83 is provided in the vicinity of a needle aperture to provide greater support to the cantileveredneedle 22 and to ensure that theneedle 22 remains centered and normal or substantially normal to the surface of the wall 84. The wall 84 may disk-shaped and dimensioned to have a diameter that is slightly larger than the outer diameter of thefirst portion 80 to provide ashoulder 94. Theshoulder 94 of thefirst portion 80 is configured to abut anannular ring 97 of thesecond portion 85 and to support a cantileveredsafety protrusion 88, the purpose of which will be described in detail below. Analignment device 81, which is dimensioned to fit into a groove to track in thesecond portion 85 and structured and arranged to control the axial sliding of thefirst portion 80 with respect to thesecond portion 85, may also be formed on the outer peripheral surface of thefirst portion 80. - The
second portion 85 may be hollow and cylindrical or substantially cylindrical in shape, including an open first and second ends 23, such that, once thefirst portion 80 of theadapter key 20 c has been properly inserted into the hollowsecond portion 85, the wall 84 of thefirst portion 80 and the circumferential walls of thesecond portion 85 produce aplenum 96 within in thesecond portion 85. A continuous, uninterruptedannular ring 97 may be formed about the entire circumference of thesecond portion 85 at the open first end. The outer diameter of the annular ring may be dimensioned to be flush with the outer peripheral surface of the circumferential wall of thesecond portion 85. The thickness and inner diameter of theannular ring 97 are dimensioned to abut theshoulder 94 of the wall 84 of thefirst portion 80, while allowing the circumferential wall of thefirst portion 80 to slidingly and axially translate within theplenum 96 of thesecond portion 85. A groove or track that is dimensioned to receive thealignment device 81 formed on the outer, peripheral surface of thefirst portion 80 may be included in theannular ring 97 and/or the inner surficial wall of thesecond portion 85. The groove or track and thealignment device 81 retain the concentric and coaxial first 80 andsecond portion 85 at a desired orientation with respect to each other during translation of thefirst portion 80 within thesecond portion 85. - The
circumferential wall 106 of thesecond portion 85 includes a plurality of, e.g., two, lockingtabs 86 and afirst opening 104, which is dimensioned to receive thesafety protrusion 88 of thefirst portion 80. The lockingtabs 86 are cantilevered sections in thecircumferential wall 106 of thesecond portion 85 and include keyed ends 90. The cantilevered nature of the lockingtabs 86, which allows the lockingtabs 86 to displace, e.g., elastically, in a radial direction, is provided by forming axially-oriented slits 87 on either side of thelocking tab 86. The keyed ends 90 include a projection that protrudes radially inward of thelocking tab 86. Thesafety protrusion 88 is supported by the wall 84 of thefirst portion 80 and cantilevered to allow theprotrusion 88 to displace, e.g., elastically, in a radial direction. Thesafety protrusion 88 includes akeyed end 89 that includes a projection that protrudes radially inward of theprotrusion 88. In some variations, thesecond end 23 of theadapter key 20 c may include arim 25 having a desired shaped and dimensions and on which aprotrusion 26 is formed. Advantageously, the shape and dimension of therim 25 can be selected to mate or couple with theopening 15 of thesocket 13 on theuser contact side 31 of thepatch pump system 30. - The
first end 21 and thefirst portion 80 of anadapter key 20 c may be structured and arranged to receive asyringe 95, while asecond end 23 and thesecond portion 85 of theadapter key 20 c may be structured and arranged to receive amedicament vial 99 to fill the reservoir of thesyringe 95 with a measured amount of a medicament, as well as to mate with thesocket 13 of thepatch pump system 30 to provide a lock and key type filling interface. In this manner, access for filling the medicament reservoir or pump 17 of thepatch pump system 30 is limited to individuals possessing theadapter key 20 c, the manufacture and distribution of which may be suitably controlled to prevent filling thepatch pump system 30 with unauthorized or improper medicaments or by unauthorized individuals. - As shown in
FIGS. 9A-9D , the embodied keyedmedicament delivery system 45 includes asyringe 95 that may be filled with a measured amount of insulin and the unique adapter key 20 c previously described. The unique adapter key 20 c initially provides a fluidic connection between thesyringe 95 and amedicament vial 99 for the purpose of filling thesyringe 95 with a measured amount of medicament and, subsequently, provides a fluidic connection between thesyringe 95 and thesocket 13 of thepatch pump device 30 for the purpose of filling thereservoir 17 with the measured amount of a medicament. - As shown in
FIGS. 8A and 8B , thehollow needle 22, extending axially in opposing directions about the wall 84, may be contained within theadapter key 20 c and may be disposed within theplenums 82, 96 of thefirst portion 80 and thesecond portion 85 to protect a user against inadvertent sticking. Thefirst portion 80 and thesecond portion 85 of theadapter key 20 c may be movable with respect to each other, so that thefirst portion 80, including theneedle 22 and thesafety protrusion 88 may translate axially within theplenum 96 of thesecond portion 85. Such relative translation forces thehollow needle 22 through theseptum 16 of the fillingport 32. - As shown in
FIGS. 9A and 9B , thefirst portion 80 of theadapter key 20 c is adapted to mate or couple with asyringe 95 at afirst end 92 thereof. In some variations, thefirst end 92 of thesyringe 95 includes a fitting 91 for releasably connecting, e.g., by tight sliding fit, with thread hags, and the like, thesyringe 95 within the plenum 82 of thefirst portion 80 at the first end of 21 the adapter key 20c. In some variations, the coupling between thefirst portion 80 and thefirst end 92 of thesyringe 95 provides an air- and fluid-tight seal, such that, when asyringe piston 93 is retracted from the reservoir of thesyringe 95, suction or a negative pressure is produced to draw a measured amount of medicament from avial 99 through theneedle 22 into the reservoir of thesyringe 95. - As shown in
FIGS. 9C and 9D , thesecond portion 85 of theadapter key 20 c is adapted to mate or couple with amedicament vial 99. In some variations, themedicament vial 99 includes a fitting 98 for releasably connecting with thesecond portion 85 of theadapter key 20 c. More specifically, as shown inFIGS. 9D and 9E , as thesecond portion 85 of theadapter key 20 c is urged over the fitting 98, theprotrusions 90 of the lockingtabs 86 and theprotrusion 89 of thesafety protrusion 88 are displaced radially outward away from theneedle 22 until theprotrusions protrusions hollow needle 22 has established fluidic communication between themedicament vial 99 and thesyringe 95. Moreover, theprotrusions protrusions syringe piston 93 may then be retracted from the reservoir of thesyringe 95, drawing a measured amount of medicament from themedicament vial 99 into the syringe reservoir. Once a desired volume of medicament has been drawn into the reservoir of thesyringe 95, themedicament delivery system 45 is ready to fill thereservoir 17 of thepatch pump system 30 and may be removed from themedicament vial 99. - Due to the many similarities of the first unique adapter key 20 a and the
adapter key 20 c ofFIGS. 9A-9E andFIGS. 10A-10D , the arrangement of thepatch pump system 30 and the steps for filling thereservoir 17 of the same may be similar. For example, in some implementations of this embodiment, thepatch pump system 30 includes a guidingsocket 13, a key-lock filling port 32, and arotatable shutter 14 c that are integrated on or into theuser contact side 31 of thepatch pump system 30. Thesocket 13, which may be disposed on the surface of theuser contact side 31, is provided as an initial guide for theadapter key 20 c. For example, anopening 15 may be formed in thesocket 13 and may be shaped and dimensioned to accommodate the outer peripheral surface and/or arim 25 of theadapter key 20 c. In some variations, thesocket 13 may also include one or moreelastic expansion elements 12 that are structured and arranged to displace radially when theadapter key 20 c is inserted into and rotated within thesocket opening 15 and oriented to position theshutter 14 c in an open or uncovered state. - As previously described, the
shutter 14 c is provided to cover and uncover aseptum 16 that seals the reservoir or pump 17. Theshutter 14 c may be configured to include a rounded T-shape having acentral portion 19 and twowing portions 18. A central,elongate opening 11 adapted to receive aprotrusion 26 of theadapter key 20 c and apin 29 about which theshutter 14 c may rotate, may be provided in thecentral portion 19 of theshutter 14 c. In some implementations, theshutter 14 c is disposed beneath theuser contact side 31 of the patch pump system 30 (FIGS. 10A-10D ), such that thepin 29 is disposed within a distal end of theelongate opening 11. In operation, theshutter 14 c is configured to rotate about thepin 29 upon application of a rotating force or torque to theprotrusion 26 of theadapter key 20 c. Although theshutter 14 c has been described as having a rounded T-shape, those of ordinary skill in the art can appreciate that a myriad of, for example, rounded and polygonal shapes may be used to effect the purpose and function of theshutter 14 c. For example, the shutter may be L-shaped, I-shaped, rectangular, triangular, and so forth. - The key-
lock filling port 32 includes an opening in the user contact side 31of thepatch pump system 30 and theseptum 16 which may be pierced, e.g., by ahollow needle 22, before the reservoir or pump 17 can be filled with a measured amount of medicament. Theshutter 14 c covers and uncovers the fillingport 32, respectively, to protect theseptum 16 from and to expose theseptum 16 to theneedle 22 of theadapter key 20 c. In addition to theshutter 14 c thepatch pump system 30 may also include areceptacle 33 to provide another degree of security fromimproper medicament containers 45. For example, thereceptacle 33 may be adapted to position themedicament delivery system 45 in a desired location before enabling delivery of a measured amount of medicament and, moreover, is dimensioned to receive asafety protrusion 88 that may be formed in theadapter key 20 c. Advantageously, thesafety protrusion 88 andreceptacle 33 are structured and arranged to mate or couple, so that, only when aproper medicament container 45 is being used can thesafety protrusion 88 advance into thereceptacle 33, enabling thehollow needle 22 to penetrate theseptum 16. -
FIGS. 10A-10D illustrate an embodiment of a method of filling thereservoir 17 of apatch pump system 30 using themedicament delivery system 45 described above. In a first step, theadapter key 20 c is inserted into thesocket 13 of thepatch pump system 30. As shown inFIG. 10A , when theadapter key 20 c is first inserted, theshutter 14 c is in a closed position, hence, theseptum 16 of thereservoir 17 is covered by one of thewings 18 of the T-shapedshutter 14 c. In a second step (FIG. 10B ), thesyringe 95 and thepatch pump system 30 are aligned for piercing theseptum 16 and delivery of the medicament. Such alignment can be achieved, for example, by rotation of thesyringe 95 and theadapter key 20 c within thesocket 13. During rotation, theprotrusion 26 on therim 25 of theadapter key 20 c slides along the peripheral wall of theelongate opening 11 of theshutter 14 c, urging the T-shapedshutter 14 c, such that the proximal end of theelongate opening 11 is aligned with the fillingport 32 and/or theseptum 16. Neitherwing 18 of theshutter 14 c covers theport 32 orseptum 16. In one variation, thesocket 13 guides and controls the rotation and, advantageously, locks theadapter 20 c in place, e.g., using theelastic expansion elements 12 and/or a resilient decent, when in the proper position for filing thereservoir 17. Advantageously, when thesyringe 95 and thepatch pump system 30 theneedle 22 and theseptum 16 as well as thesafety protrusion 88 and thereceptacle 33 are properly aligned. - With the
shutter 14 c in an open state, in a next step (FIG. 10C ), once thesafety protrusion 88 is aligned with thereceptacle 33, theneedle 22 can be advanced, e.g., axially, to the delivery position, piercing theseptum 16 and allowing for the delivery of medicament to thereservoir 17 in thepatch pump device 30. Once thereservoir 17 has been filled, themedicament delivery system 45 can be retracted, e.g., by twisting and lifting thesyringe 95, to remove and disengage theadapter 20 c andsyringe 95 from thepatch pump device 30 and to re-close theshutter 14 c. As depicted, thesyringe 95 andadapter 20 c are twisted past the shutter open position, to cover theport 32 andseptum 16 with thesecond wing 18 of theshutter 14 c. Alternatively, the system could be rotated in the opposite direction to cover theport 32 andseptum 16 with thefirst wing 18. Advantageously, to prevent additional uses of theadapter 20 c, in some variations, certain features, such as thesafety protrusion 88, may be frangible so as to break off after filling has been completed, e.g., through twisting while thesafety protrusion 88 is contained within thereceptacle 33 to the second, re-closed position. - A further variation to the
adapter key 20 c andmedicament delivery system 45 shown inFIGS. 8A through 9B is depicted inFIGS. 11A through 12D . Several of the components and their functional relationships are common to the embodiments ofFIGS. 8A through 9B andFIGS. 11A through 12F , and may be used in a similar manner. One difference to thesecond portion 85 of theadapter key 20 d is the inclusion of aremovable safety tab 110 that is structured and arranged to prevent premature deployment of theneedle 22 and, thus, exposing the sharp end of theneedle 22 while filling thesyringe 95 from amedicament vial 99. In some implementations, theremovable safety tab 110 is formed on the outer,circumferential wall 106 of thesecond portion 85 of theadapter key 20 d, e.g., diametrically opposed to theaperture 104. In some implementations, the safety tab 110 (FIGS. 11A and 11B ) includes a paddle orgrip portion 101 and plurality of, e.g., two,elongate legs 100. In some implementations, thepaddle portion 101 is perpendicularly or substantially perpendicularly attached to each of theelongate legs 100 at ajuncture 102 to form an L shape. Theelongate legs 100 are removably attached to thecircumferential wall 106 of thesecond portion 85 of theadapter key 20 d and pivotable about corresponding weakenedareas 103 in thesecond portion 85. Theelongate legs 100, which extend from thecircumferential wall 106 of thesecond portion 85, are configured to run axially along the peripheral surface of thefirst portion 80 of theadapter key 20 d. More particularly, theelongate legs 100 are axially (longitudinally) dimensioned such that when thefirst portion 80 of theadapter key 20 d is attached to the syringe 95 (FIGS. 12A-12D ), thejuncture 102 abuts the lip 105 of thesyringe 95. Advantageously, such an abutment, retains the sharp end of theneedle 22 within theplenum 96 of thesecond portion 85, preventing exposing theneedle 22 prematurely. - Advantageously, while the
second portion 85 of theadapter key 20 d is attached to the medicament vial 99 (FIG. 12C ), as previously described in connection withFIGS. 9C through 9E , thesafety tab 110 prevents exposing theneedle 22, the abutment afforded by thesafety tab 110 does not prevent or hinder theneedle 22 from piercing thevial 99 septum or interfere with filling thesyringe 95 with a measured amount of medicament. Thereafter, once themedicament vial 99 is removed from thesecond portion 85 of theadapter key 20 d, and before themedicament delivery system 45 is coupled to thepatch pump system 30, thetab 110 may be removed from theadapter key 20 d, e.g., by rotating thepaddle portion 101 about thejuncture 102 and/or by pulling thepaddle portion 102 towards the weakenedsections 103. With some manual twisting and wiggling, thetab 110 should break away from thecircumferential wall 106 of thesecond portion 85 of theadapter key 20 d. With thetab 110 removed, as previously describe in connection withFIGS. 10A through 10C , theadapter key 20 d, which is now substantially the same as theadapter key 20 c, may be mated with or coupled to thesocket 13 of thepatch pump device 30 and longitudinal advancement of theneedle 22 to pierce theseptum 16 at the fillingport 32 to the medicament delivery position is possible. - Yet another illustrative embodiment of the present invention is depicted in
FIGS. 13A through 16F . The patch pump system 30 (FIGS. 15A and 15B ) includes a guiding cap 130 (FIG. 13B ) that is integrated on or into theuser contact side 31 of thepatch pump system 30 and anarcuate shutter 14 e (FIG. 13A ) that also is integrated on or into thepatch pump system 30. Thearcuate shutter 14 e may be disposed beneath theuser contact side 31 of thepatch pump system 30, so as to open and close the key-lock filling port 32, respectively, to expose and cover theseptum 16 to thereservoir 17. Although the invention will be described as having a singlearcuate shutter 14 e, those of ordinary skill in the art can appreciate that there may be multiplearcuate shutters 14 e, e.g., a number less than or equal to the number ofresilient tabs 48 on the adapter key 20 e. In some implementations, a biasing system, e.g., comprising one or more springs, may bias the arcuate shutter(s) 14 e toward the closed position (FIG. 16A ). Accordingly, the shutter(s) 14 e would require a constant, greater opposing force to remain in the open position (FIG. 16C ), which can be provided by the adapter key 20 e. - The cap 130 (
FIG. 13B ), which may be disposed on or integrated into the surface of theuser contact side 31, is provided as an initial guide for the adapter key 20 e (FIG. 13C ). For example, thecap 130, e.g., made of a hard plastic and the like, may be shaped and dimensioned to accommodate a plurality ofresilient tabs 48 that are formed on asecond portion 150 of the adapter key 20 e. In some variations, thecap 130 is hollow with a conical or frusto-conical shape that includes a plurality of raisedportions 136 that project, e.g., in an axial direction, from abase portion 138 and a plurality of cut-outportions 137 that cut into thebase portion 138. In some variations, the cut-outportion 137 and the raisedportion 136 alternate about the periphery of thecap 130. Although thecap 130 is being described as having a conical or frusto-conical shape, that is done for illustrative purposes only, as thecap 130 could assume any practical shape. Advantageously, thecap 130 includes a centrally located opening 139 that passes through theentire cap 130 and that enables theneedle 22 to access theseptum 16, as will be described in greater detail below. Each of the cut-outportions 137 is dimensioned to receive and to accommodate a correspondingresilient tab 48 formed in the adapter key 20 e. More particularly, each of the cut-outportions 137 is configured to align with a corresponding opening 119 (FIGS. 16C and 16E ) formed in theuser contact side 31 of thepatch pump system 30. Theopenings 119 are adapted to position themedicament delivery system 45 in a desired location before delivering the measured amount of medicament. - As shown in
FIGS. 14a and 14b , themedicament delivery system 45 includes a medicament container, e.g., asyringe 95 that can be filled with a measured amount of insulin, and an adapter key 20 e that is structured and arranged to mate or couple with theguide cap 130 and to provide a fluidic connection between thesyringe 95 and areservoir 17 in thepatch pump device 30, for the purpose of filling thereservoir 17 with a measured amount of a medicament. As shown inFIG. 13C , in some implementations, the adapter key 20 e includes afirst portion 143 and asecond portion 150, which are separated by awall 128 through which an aperture for aneedle 22 is formed. To provide greater stiffness to the cantileveredneedle 22, a built-upportion 121 may be provided on at least one side of the aperture, e.g., on thefirst portion 143 side or thesecond portion 150 side of thewall 128. Thehollow needle 22, which is disposed in the aperture in thewall 128 and extends axially in opposing directions, may be surrounded by a plurality ofresilient tabs 48 in thesecond portion 150 and by acircumferential wall 140 in thefirst portion 143 of the adapter key 20 e to protect a user against inadvertent sticking. - The
first portion 143 of the adapter key 20 e is structured and arranged to mate or couple with a medicament container, e.g., asyringe 95, while filling thesyringe 95 from avial 99 and While delivering a measured amount of medicament to thereservoir 17 in thepatch pump system 30. In some variations, thefirst portion 143 includes acircumferential wall 140 that, with thewall 128, defines a plenum space in thefirst portion 143. The plenum space and thecircumferential wall 140 enable releasably connecting, e.g., by sliding fit, with threadings and the like, the adapter key 20 e to thesyringe 95. Thesecond portion 150 of the adapter key 20 e is structured and arranged to mate or couple with amedicament container 99, e.g., a medicament vial., for the purpose of filling thesyringe 95 with a measured volume of medicament; to mate or couple with theguide cap 130 of thepatch pump system 30; and to move the arcuate shutter(s) 14 e, so as to expose theseptum 16 to thereservoir 17 to theneedle 22. Unlike previous embodiments, rotation of themedicament delivery device 45, once it has been properly mated with theguide cap 130 on thepatch pump system 30, is not necessary. - In some implementations, in order to fill the
syringe 95, a special vial cap 41 (FIG. 13D ) for connecting themedicament delivery system 45 to themedicament vial 99 is needed. At one end, thecap 41 resembles theguide cap 130, while the other end includes askirt 42 that is dimensioned to accommodate thesyringe 95. In some variations, thevial cap 41 is hollow having, at the first end, a conical or frusto-conical shape that includes a plurality of raisedportion 44 and a plurality of cut-outportions 46 that alternate about the periphery of thecap 130. Although thevial cap 41 is being described as having a conical or frusto-conical shape, that is done for illustrative purposes only, as thecap 41 could assume any practical shape. Thevial cap 41 includes a centrally located opening 43 that passes through theentire cap 41 for enabling theneedle 22 to have access to the septum of themedicament vial 99. Each of the cut-outportions 46 is dimensioned to receive and to accommodate a correspondingresilient tab 48. In some variations, one end of each cut-outportion 46 includes awedge 141 that is structured and arranged to temporarily catch and hold, e.g., along astop 142, the lockingtabs 49 formed on the end of each of theresilient tabs 48. - In operation, the
resilient tabs 48 of the adapter key 20 e are aligned with the cut-outportions 46 of thevial cap 41 before the adapter key 20 e is urged in an axial direction towards themedicament vial 99. As theresilient tabs 48 ride along the cut-outportions 46, thetabs 48 are displaced radially outward, until theresilient tabs 48 reach the end of thewedge 141, at which point the lockingtabs 49 engage or abut thestop 142. With the lockingtabs 49 abutting thestop 142, theneedle 22 will have pierced the septum of themedicament vial 99, to provide fluid communication between themedicament vial 99 and thesyringe 95. Refraction of theplunger 93 of thesyringe 95 creates a suction or negative pressure, drawing a measured amount of the medicament into thesyringe 95. - The
arcuate shutter 14 e is provided to cover and uncover theseptum 16, which, respectively, interrupts and provides a fluid communication with the reservoir or pump 17. As shown inFIG. 13A , thearcuate shutter 14 e may be configured to include an L-shapedend 132 at one, e.g., a distal, end; a U-shaped, e.g., proximal, end; and an arcuatecentral portion 131 therebetween. In some variations, the U-shaped end includes a pair oflegs 133 separated by anopening 134. In some implementations, theshutter 14 e is disposed beneath theuser contact side 31 of thepatch pump system 30, such that in an at rest state, the arcuatecentral portion 131 of thearcuate shutter 14 e is beneath the fillingport 32, covering theseptum 16. -
FIGS. 15A and 15B illustrate an embodiment of a method of mating or coupling amedicament delivery system 45 having adapter key 20 e with theguide cap 130 of apatch pump system 30, whileFIGS. 16A through 16F illustrate an embodiment of a method of filling thereservoir 17 of thepatch pump system 30, using themedicament delivery system 45 having adapter key 20 e. in a first step (FIGS. 15A and 15B ), the adapter key 20 e is inserted into theguide cap 130 of thepatch pump system 30, such that each of theresilient tabs 48 of the adapter key 20 e are aligned with a corresponding cut-outportion 137 in theguide cap 130, as well as with theopenings 119 inuser contact surface 31 of thepatch pump system 30. As shown inFIGS. 16A and 16B , when the adapter key 20 e is first inserted and properly mated in theguide cap 130, one or more of theresilient tabs 48 is positioned above acorresponding opening 119, as well as above the L-shapedend 132 of thearcuate shutter 14 e. In this position, thearcuate shutter 14 e is in a closed position, such that thecentral portion 131 of thearcuate shutter 14 e covers theseptum 16 of thereservoir 17. Theneedle 22 and the coveredseptum 16 are properly aligned for delivery of the medicament. In a second step (FIGS. 16C and 16D ), themedicament delivery system 45 may be urged further into thepatch pump system 30, such that eachresilient tab 48 passes through acorresponding opening 119 and, at least one of theresilient tabs 48 contacts the L-shapedend 132 of thearcuate shutter 14 e. Further urging of themedicament delivery system 45 displaces thearcuate shutter 14 e to an open position, aligning theU-shaped opening 134 and the fillingport 32 and exposing theseptum 16 to theneedle 22. - With the
arcuate shutter 14 e now open (FIG. 16C ), theneedle 22 can be advanced, e.g., with further urging of themedicament delivery system 45, to the delivery position in a next step (FIGS. 16E and 16F ), that pierces theseptum 16 and enables delivery of medicament into thereservoir 17 in thepatch pump device 30. Once thereservoir 17 has been filled, themedicament delivery system 45 can be retracted, e.g., by lifting thesyringe 95, to remove and disengage theadapter 20 e from theguide cap 130 of thepatch pump device 30 and to re-close thearcuate shutter 14 e. Advantageously, to prevent additional uses of theadapter 20 e, in some variations, certain features, e.g., theresilient tabs 48, may be frangible so as to break off after filling has been completed, e.g., by twisting themedicament delivery system 45 to cause theresilient tabs 48 to break against the peripheral surface ofopenings 119. - In still another embodiment, an implementation of a self-contained
medicament delivery system 170 is depicted inFIGS. 17 through 19 . The self-containedmedicament delivery system 170 includes a unique adapter key 20 f that is disposed at anoutlet 160 of thesystem 170 and adapted to mate or couple with the socket on theuser contact side 31 of thepatch pump system 30. Theadapter key 20 f and socket, as well as the correspondingshutter 14 f integrated into thepatch pump system 30, may be of a type discussed hereinabove and, as a result will not be discussed in further detail. - In some variations, the medicament delivery system 170 (
FIG. 17 ) further includes ahousing 171, aninlet 174, for receiving a medicament container, e.g., amedicament vial 99; anoutlet 160 that includes a removable or replaceable adapter key 12 f; alatch 172, for selectively coupling themedicament container 99 to asecond needle 181, and apump actuation button 177. - Internally, in some variations, the
system 170 includes at least oneconduit 180, e.g., sterile tubing and the like, and a pump, e.g., a peristaltic pump,mechanism 165 for delivering a measured amount of a medicament, e.g., about 0.2 mL of insulin per actuation of thebutton 177, into thereservoir 17 of thepatch pump system 30. For example, in some applications, theconduit 180 is arranged in a serpentine configuration having a looped portion. The embodiedpump mechanism 165 includes a gear-drivenrotor 179 having a plurality of, e.g., three,rollers 189 disposed at the ends of a corresponding plurality of rotor arms, and anelongate rack 178 having a plurality of teeth. As shown inFIG. 18 , when a user presses down on thepump activation button 177, e.g., using her thumb or other digit, therack 178 translates linearly in the same direction as the applied force, causing therotor 179 to rotate. - The operation of a
peristaltic pump 165 is well known to those skilled in the art; accordingly, it will only be described briefly in the context of the present invention and use. In short, as therotor 179 of the gear-drivenperistaltic pump 165 rotates, a leading (in the direction of rotation)roller 189 pinches off a leading portion of the flexible, fluid-filledconduit 180. As the leadingroller 189 continues to move, a trailingroller 189 pinches off a second, trailing portion of the flexible, fluid-filledconduit 180, confining or trapping a measured volume of the fluid, e.g., 2 mL, between the leading and trailingrollers 189. The leading and trailingrollers 189 continue to rotate with a measured volume of fluid trapped between therebetween. Once the leadingroller 189 reaches apre-determined location 166, it no longer pinches the flexible,conduit 180 and the trailingroller 189 forces the fluid out of theconduit 180 and into theneedle 22 and thereservoir 17. Each pump event initiated by depressing thepump actuation button 177 delivers a pre-determined amount of medicament to thereservoir 17, e.g., with about 0.2 mL of insulin. - Needle-carrying
fixtures conduit 180, e.g., to provide an air- and fluid-tight sliding fit with theconduit 180. Afirst fixture 182 a is translatably disposed within theadapter key 20 f and configured, upon activation of theneedle deployment device 173, to introduce a needle through the fillingport 32 and theseptum 16 to provide a fluid communication to thereservoir 17 of thepatch pump system 30. Asecond fixture 182 b is disposed in the vicinity of theinlet 174 and latch 172 and configured, upon activation of thelatch 172, to urge the septum covering themedicament vial 99 around theneedle 181 to provide a fluid communication. More specifically, activation of the latch 172 (FIG. 19 ) causes thetoggle 175 to rotate about apin 188, such that adistal tip 186 of thetoggle 175 clears ashelf 176 that otherwise retains thedistal tip 186, preventing themedicament vial 99 from moving. Once thedistal tip 186 of thetoggle 175 clears ashelf 176, themedicament container 99 is able to slide into contact with asecond needle 181. - In some embodiments, the filling
pump device 170 is shipped attached to thepatch pump device 30, including sterile tubing connecting to thepatch pump device 30 at theoutlet 160 and to amedicament container 99 at theinlet 174. A counter can also be included to keep track of the filling amount. For example, in one implementation, the counter may count the number of rotations of therotor 179 of the gear-drivenperistaltic pump 165, realizing that the volume of medicament contained within the sterile tubing, between the leading and trailingrollers 189 rotates, is substantially constant, e.g., 2 mL. For the illustrated implementation, one rotation of therotor 179 would deliver three measured quantities of the medicament or 6 mL to thereservoir 17 of thepatch pump device 30. - The terms and expressions employed herein are used as terms and expressions of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described or portions thereof. In addition, having described certain embodiments of the invention, it will be apparent to those of ordinary skill in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The features and functions of the various embodiments may be arranged in various combinations and permutations, and all are considered to be within the scope of the disclosed invention. Accordingly, the described embodiments are to be considered in all respects as only illustrative and not restrictive. Furthermore, the configurations, materials, and dimensions described herein are intended as illustrative and in no way limiting. Similarly, although physical explanations have been provided for explanatory purposes, there is no intent to be bound by any particular theory or mechanism, or to limit the claims in accordance therewith.
Claims (28)
1. A patch pump system comprising:
a patch pump device comprising:
a filling port, and
a shutter proximate the filling port movable between a closed position and an open position and adapted to prevent access to the filling port in the closed position; and
a filling adapter adapted to be coupled to the filling port and move the shutter from the closed position to the open position.
2. The patch pump system of claim 1 , wherein the filling port comprises a septum.
3. The patch pump system of claim 1 , wherein the filling port is accessible from a user contact side of the patch pump device.
4. The patch pump system of claim 1 , wherein the shutter is accessible from a user contact side of the patch pump device.
5. The patch pump device of claim 1 , wherein the shutter is disposed within the patch pump device.
6. The patch pump system of claim 1 , wherein the shutter is disposed within the filling port.
7. The patch pump system of claim 1 , wherein the shutter defines a shutter opening.
8. (canceled)
9. The patch pump system of claim 1 , wherein the shutter comprises a valve.
10. The patch pump system of claim 1 , wherein the patch pump device defines a device opening for coupling the filling adapter to the filling port and enabling controlled movement of the shutter.
11-13. (canceled)
14. The patch pump system of claim 1 , wherein the filling adapter comprises a hollow needle.
15. (canceled)
16. The patch pump system of claim 1 , wherein a first end of the filling adapter is adapted to mate with a medicament container.
17. (canceled)
18. The patch pump system of claim 1 further comprising a socket adapted to receive the filling adapter.
19. (canceled)
20. A filling adapter for use with a patch pump device, the filling adapter comprising:
a first end adapted to mate with a medicament container; and
a second end adapted to couple to a filling port of a patch pump device and to move a shutter of the patch pump device from a closed position to an open position.
21-27. (canceled)
28. A method of filling a patch pump device, the method including the steps of:
coupling a first end of a filling adapter to a medicament container;
coupling a second end of the filling adapter to a filling port on a patch pump device to move a shutter proximate the filling port from a closed position preventing access to the filing port to an open position allowing access to the filling port; and
filling a reservoir of the patch pump device with medicament from the medicament container via the filling port.
29. The method of claim 28 , wherein coupling the first end of the filling adapter to the medicament container comprises receiving at least a portion of the medicament container in a recess of the filling adapter.
30. The method of claim 28 , wherein coupling the first end of the filling adapter to the medicament container comprises piercing the medicament container with a needle.
31. The method of claim 28 , wherein coupling the second end of the filling adapter to the filling port on the patch pump device comprises inserting a mating surface of the second end into the patch pump device.
32-33. (canceled)
34. The method of claim 28 , wherein the medicament container comprises at least one of a syringe, a pen, a cartridge, and a vial.
35. The method of claim 28 , wherein filling the reservoir comprises transferring medicament from the medicament container under pressure.
36. The method of claim 28 further comprising, after coupling the first end of the filling adapter to the medicament container, drawing medicament into the medicament container.
37-43. (canceled)
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US16/425,181 US20190328960A1 (en) | 2014-05-20 | 2019-05-29 | Medicine Delivery Device with Restricted Access Filling Port |
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US16/425,181 US20190328960A1 (en) | 2014-05-20 | 2019-05-29 | Medicine Delivery Device with Restricted Access Filling Port |
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-
2015
- 2015-05-20 WO PCT/IB2015/001592 patent/WO2015177652A1/en active Application Filing
- 2015-05-20 CN CN201580037364.XA patent/CN106659845A/en active Pending
- 2015-05-20 EP EP15770636.7A patent/EP3145561A1/en not_active Withdrawn
- 2015-05-20 US US14/717,697 patent/US10350349B2/en not_active Expired - Fee Related
-
2019
- 2019-05-29 US US16/425,181 patent/US20190328960A1/en not_active Abandoned
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20190358393A1 (en) * | 2016-11-10 | 2019-11-28 | Sensile Medical Ag | Drug delivery device |
US11612687B2 (en) * | 2016-11-10 | 2023-03-28 | Sensile Medical Ag | Drug delivery device |
Also Published As
Publication number | Publication date |
---|---|
WO2015177652A1 (en) | 2015-11-26 |
EP3145561A1 (en) | 2017-03-29 |
US20160008536A1 (en) | 2016-01-14 |
US10350349B2 (en) | 2019-07-16 |
CN106659845A (en) | 2017-05-10 |
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