US20210330552A1 - Sterilization fluid path with barrier removal - Google Patents
Sterilization fluid path with barrier removal Download PDFInfo
- Publication number
- US20210330552A1 US20210330552A1 US17/369,666 US202117369666A US2021330552A1 US 20210330552 A1 US20210330552 A1 US 20210330552A1 US 202117369666 A US202117369666 A US 202117369666A US 2021330552 A1 US2021330552 A1 US 2021330552A1
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- United States
- Prior art keywords
- sterilized
- fluid path
- container holder
- barrier
- needle
- 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.)
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- 230000001954 sterilising effect Effects 0.000 title abstract description 20
- 238000004659 sterilization and disinfection Methods 0.000 title description 16
- 230000035515 penetration Effects 0.000 claims description 43
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1443—Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
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- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
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- 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
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M2005/14573—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for quick connection/disconnection with a driving system
Definitions
- combination patch pumps which include a pump and a solution (e.g., drug)
- the solution while inside the pump, cannot pass a sterilization process for a fluid path that transports the solution.
- Using an unsterilized fluid path can cause adverse effects such as infections and is unacceptable from a risk management perspective
- a device and method for assembling a container holder in a clean environment, aseptically adding a solution to a primary container, inserting the primary container into the container holder, applying a first barrier to the container holder, sterilizing the container holder comprising the primary container and the applied first barrier to provide a sterilized container holder, assembling a fluid path module in a clean environment, the assembling comprising applying a second barrier to a first end of the sterilized fluid path module, sterilizing the fluid path module to provide a sterilized fluid path module and assembling a delivery device comprising the sterilized container holder and the sterilized fluid path module.
- FIG. 1A is a graphic depiction of a patch pump for a user.
- FIG. 1B is a graphic depiction of the outer casing of an example of a patch pump.
- FIG. 1C is a graphic depiction of an example of a patch pump with the outer casing removed.
- FIG. 2A is a graphical depiction of a container holder
- FIG. 2B is a graphical depiction of primary container with solution, inserted into a container holder
- FIG. 2C is a graphical depiction of a sterilized fluid path module
- FIG. 2D is a graphical depiction of barriers associated with a sterilized container holder and fluid path
- FIG. 3 is a graphical depiction of a sterilization process
- FIG. 4A is a graphical depiction of a penetration needle and a user needle penetrating barriers
- FIG. 4B is a graphical depiction of a penetration needle and a user needle penetrating surfaces
- FIG. 5 is a graphical description of assembling a delivery device.
- the apparatus and methods may allow for prescription or standard off-the-shelf drug cartridges, vials, syringes, or other containers (hereinafter generally referred to as a container), to be utilized without compromising the sterility of the solution.
- a container may enable a patient to self-administer a solution in a self-contained wearable patch pump form factor that is cost effective and comfortable to wear.
- the disclosure subject matter provided herein may allow the manufacturing and use of a drug delivery device that includes a sterilized fluid path and container holder.
- FIGS. 1A-1C show an example delivery device is shown via patch pump 100 , which may be used with the sterilized container holder and sterilized fluid path as further described herein.
- a sterilized container holder may be provided in accordance with the subject matter disclosed herein.
- a delivery device may include such a sterilized container holder, which may connect to a sterilized container holder, in accordance with the subject matter disclosed herein.
- patch pump 100 is an example, and other patch pumps or delivery devices may be used to implement a sterilized fluid path and sterilized container holder, as disclosed herein.
- FIG. 1A is a graphic depiction of a patch pump 100 on a patient 115 .
- the patch pump 100 includes a base 125 that contacts the patient's skin.
- the base 125 includes an adhesive liner that affixes the patch pump 100 to the patient 115 .
- the patch pump 100 may further include a user flow control switch 135 .
- the user flow control switch 135 may enable a user to pause and control the flow rate of a solution.
- the patch pump 100 further includes a start button 105 that may be pressed by a user to cause a cannula and/or needle to be inserted into the patient and the solution to flow from a drug container 130 through the cannula and/or needle into the patient.
- the patch pump 100 may further include a drug viewing window 145 .
- This viewing window may enable a user to view the amount of a solution that remains in the drug container 130 .
- the patch pump 100 may also include one or more visual indicators 155 .
- the visual indicators 155 provide feedback on the operational status of the system.
- the operational status of the system may include warnings such as an over/under temperature warning, drug expiration warning and over/under pressure warning.
- the operational status may include information indicating that the drug is being administered, how much time is remaining for the drug dosage to be completed and the current flow rate.
- the visual indicators may include LEDS, LCD displays or other similar display technologies known in the art.
- the information that is displayed by visual indicators may also be wirelessly transmitted to a mobile computing device such as a smart phone utilizing any of the wireless communication methods known in the art.
- the patch pump 100 may further include a removable safety 170 .
- the removable safety mechanically engages the start button 105 and prohibits the start button 105 from being involuntary pressed.
- FIG. 1C shows additional components of a patch pump 100 .
- the patch pump 100 may also include a needle insertion component 185 that is mechanically connected to the start button 105 .
- the patch pump 100 includes an electronic circuit board 140 that includes control circuitry for the visual indicators 155 , user flow control switch 135 and a pressurization system 150 .
- the electronic circuit board 140 may be communicatively connected to one or more sensors. These sensors may include pressure sensor 165 and proximity sensor 175 or any other applicable sensor such as a haptic feedback sensor (not shown) or other indicator.
- the electronic circuit board 140 may also include a memory 190 .
- the memory 190 may store dosing instructions for the administration of the solution.
- the memory 190 may also store information regarding the administration of the solution.
- This information IT may include, time, date, and flow rate when the solution was administered.
- the electronic circuit board 140 may control the visual indicators 155 and the pressurization system 150 based on the information stored in the memory and the feedback from the sensors.
- the electronic circuit board 140 may include a communication module that enables the transmission of information stored in the memory 190 to a wireless computing device. In addition, the communication module may also receive updated dosing instructions that are subsequently stored in the memory 190 .
- a delivery device may be assembled such that a sterilized container holder and a sterilized fluid path are provided to operate the delivery device.
- the sterilized container holder and the sterilized fluid path may be assembled via two separate processes such that they may be provided as separately packaged components.
- a user may be able to use combinations two or more different container holders (e.g., two or more different drugs) with different sterilized fluid path components.
- a first sterilized container holder and a first sterilized fluid path may be used in conjunction with a patch pump at a first time.
- a second sterilized container holder with a different drug than the first sterilized container holder and a second sterilized fluid path that is similar to the first sterilized fluid path may be provided.
- multiple sterilized fluid path components may be bought as a pack of two or more sterilized fluid path components such that they can be used with different drugs via different sterilized container holders.
- a septic process may be used when transferring or handling a solution (e.g., a drug) and a sterilization process may apply to components where the transfer or contamination of a solution is not applicable.
- a solution e.g., a drug
- a sterilized container holder may be assembled such that a non-sterilized container holder may be provided in a clean environment.
- a clean environment may be, for example, an ISO certified clean room.
- the container holder may go through a sterilization process either inside or outside the clean environment.
- a solution, such as a drug may be inserted into a primary container, inside a septic environment.
- the primary container may be a sterilized primary container.
- the solution may be inserted into the primary container via an aseptic filling technique.
- the aseptically filled primary container containing the solution may then be stoppered to seal the solution inside of the primary container, resulting in an overall aseptic insertion of the solution into the primary container.
- the stoppered primary container with the aseptically filled solution may be inserted into the container holder after the container holder is sterilized, resulting in a sterilized container holder with a primary container including a solution.
- the sterilized container holder may include a barrier, as further disclosed herein, that seals the sterilized container holder such that the sterilized container holder maintains its sterilization.
- a sterilized fluid path may be assembled in a clean room.
- the fluid path may include a penetration needle, a channel via which the solution traverses, and a user needle configured to insert into a user or into a cannula to provide the solution to a user.
- the penetration needle may, as further disclosed herein, receive and/or draw solution from a primary container.
- the channel may be a line, pipe, hose, or other mode to transport fluid from at least the penetration needle to the user needle.
- the user needle may be configured to insert into a user or to provide fluid to a cannula or other needle that provides the solution to a user.
- the sterilized fluid path and/or fluid path may also include a drive module.
- the drive module may be configured to cause the solution to be driven from the primary container, through the sterilized fluid path, and to a user.
- the sterilized fluid pathway may include one or two barriers, as further disclosed herein, that seal the sterilized fluid path such that the sterilized fluid path maintains its sterilization.
- a first such barrier may be on the end where the penetration needle is located and a second such barrier may be on the end where the user needle is located.
- a clean environment may be a clean room or other environment that meets a given standard. Clean rooms may be classified according to the cleanliness level of the air inside them.
- the clean room class may correspond to the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air.
- the primary authority in the US and Canada is the ISO classification system ISO 14644-1, though it will be understood that the clean environment disclosed herein is not limited to the ISO classification.
- This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room).
- the most common classes are ISO 7 and ISO 8.
- FIG. 2A shows an empty container holder 211 sterilization process 210 .
- the empty container holder 211 may be assembled, manufactured, prepared or otherwise provided in a clean environment such as an ISO certified clean room (e.g., ISO 8), as disclosed herein.
- the container holder may be handled or otherwise manipulated by a robotic arm or other machine, or may be handled or otherwise manipulated by a user.
- the empty container holder 211 may experience sterilization at 212 such that the container holder may be sterilized to remove particles, dust, bacteria, contaminants, or other components that are not desirable.
- FIG. 2B shows a clean assembly 220 during which solution 221 is aseptically inserted and stored in a primary container 222 , stoppered, and inserted into a sterilized container holder 227 .
- the container holder 227 may be assembled, manufactured, prepared or otherwise provided in a clean environment such as an ISO certified clean room (e.g., ISO 5), as disclosed herein.
- a solution 221 may be inserted into primary container 222 via an aseptic filling 223 .
- Aseptic filling 223 may also include sterilization of the solution 221 , sterilization of the primary container 222 , and conservation of sterility during the filling.
- Equipment and packaging materials used during the aseptic filing 223 may be sterilized with various medium or combination of mediums such as via saturated steam, superheated steam, hydrogen peroxide, heat, and/or other treatments.
- a stopper 226 may be applied to an aseptically filled primary container 224 at the stoppering step 225 .
- the stoppering step 225 may include applying the stopper 226 to the aseptically filled primary container 224 via any applicable technique such as forced or mechanical stoppering such that the stopper 226 seals the solution 221 inside the aseptically filled primary container 224 .
- the sterilized container 211 of FIG. 2A may be provided such that the stoppered aseptically filled primary container 224 is inserted into the empty container holder 211 to provide a sterilized container holder 227 .
- the aseptically filled primary container 224 may be inserted into the empty container holder 211 in a clean environment, which may be the same as or different from the clean environment in which the solution 221 is aseptically filled into the primary container 222 .
- a barrier may be applied to the sterilized container holder 227 .
- FIG. 2C shows a penetration needle 231 , a channel 232 , and a user needle 233 such that the channel 232 connects the penetration needle 231 to the user needle 233 .
- the penetration needle 231 is configured to puncture a primary container (e.g., aseptically filled primary container 224 of FIG. 2B ) inside a container holder (e.g., the sterilized container holder 227 of FIG. 2B ) such that solution (e.g., solution 221 of FIG. 2B ) is provided to the channel 232 and to a user via the user needle 233 .
- a primary container e.g., aseptically filled primary container 224 of FIG. 2B
- a container holder e.g., the sterilized container holder 227 of FIG. 2B
- solution e.g., solution 221 of FIG. 2B
- the fluid path module 230 may include drive module 234 , penetration needle 231 , channel 232 , and user needle 233 that are assembled, manufactured, prepared or otherwise provided in a clean environment such as an ISO certified clean room (e.g., ISO 7), as disclosed herein.
- the drive module 234 may include components that cause a solution to be inserted into and/or traverse through the fluid path module 230 and, specifically, via the penetration needle 231 , channel 232 , and user needle 233 .
- the device module may include on or more electronic components, mechanical components, or a combination of the same. According to an implementation, a drive module 234 may not be provided such that a patch pump, patch pump component(s), or other component may substitute for the functionality provided by the drive module 234 .
- the fluid path module 230 may experience sterilization, to provide a serialized fluid path module 240 , such that the components of the fluid path module 230 including the penetration needle 231 , channel 232 , user needle 233 and drive module 234 are sterilized to remove particles, dust, bacteria, contaminants, or other components that are not desirable.
- the sterilized fluid path module 240 may include a sterilized penetration 241 , a sterilized channel 242 , sterilized user needle 243 and sterilized drive module 244 .
- the sterilized fluid path module 240 may be sealed or otherwise treated to mitigate contamination.
- a delivery device 250 may be assembled and may include the sterilized container holder 227 and a sterilized fluid path 240 including sterilized penetration 241 , a sterilized channel 242 , and sterilized user needle 243 .
- the delivery device 250 may be a standalone device or may be configured to incorporate the sterilized container holder 227 and sterilized fluid path 240 into its operation.
- the delivery device 250 may be patch pump 100 of FIG. 1A - FIG. 1C , a different patch pump or a different device configured to provide a solution.
- one or more barriers may be applied to the sterilized container holder 227 and/or sterilized fluid path 240 .
- a container holder barrier 251 may be applied to the container holder 227 .
- a penetration needle barrier 252 may be applied to a first end of the sterilized fluid path 240 (e.g., on the end closest to the sterilized penetration needle 241 ).
- a user needle barrier 253 may be applied to a second end of the sterilized fluid path 240 .
- the barriers 251 , 252 , and 253 may all be the same or may be similar or, alternatively, may be different from each other.
- the material for barriers 251 , 252 , and 253 may be any applicable single layer or multi layer material configured to provide a seal or barrier between the component that the respective barrier 251 , 252 or 253 is attached to and anything external to the component.
- the material for barriers 251 , 252 , and 253 may be aluminum foil, Tyvek or material with properties the same as or similar to Tyvek (collectively referred to as “Tyvek” herein), or a thermoplastic elastomer (TPE).
- FIG. 3 shows a complete diagram including the components and steps provided in FIG. 2A-D .
- an empty primary container 211 is provided in a clean environment and is sterilized at 212 .
- a solution 221 is aseptically inserted, at 223 , into a primary container 222 .
- the primary container 222 is filled with the solution 221 and is stoppered 225 via stopper 226 .
- the stoppered and aseptically filed primary container 224 is placed inside the container holder (after sterilization 212 ) such that a sterilized container holder 227 includes a primary container 224 including the solution 221 .
- a penetration needle 231 , channel 232 , and user needle 233 is assembled with a drive module 234 and sterilized in a clean environment to result in a sterilized fluid path 240 that includes a sterilized penetration needle 241 , sterilized channel 242 , sterilized user needle 243 and sterilized drive module 244 .
- a delivery device 250 includes the sterilized container holder 227 and sterilized fluid path 240 as well as container holder barrier 251 attached to the sterilized container holder 227 , penetration needle barrier 252 attached to a first end of the sterilized fluid path 240 near the sterilized penetration needle 241 , and a user needle barrier 253 attached to a second end of the sterilized fluid path 240 near the sterilized user needle 243 .
- the barrier(s) may be configured to seal the components that they are attached to and may further be configured to maintain the sterility of a component that they are attached to.
- the container holder barrier 251 may be configured to seal the sterilized container holder 227 such that the sterility of the sterilized container holder 227 is maintained as a result of seal provided by the container holder barrier 251 .
- the sterilized container holder 227 and the sterilized fluid path 240 may be manufactured and/or shipped at the same time or may be manufactured/and or shipped as separately packaged items. Such flexibility may reduce cost and allow separate uses of the sterilized container holder 227 and the sterilized fluid path 240 .
- FIG. 4A shows an implementation of the disclosed subject matter where the penetration needle 241 is configured to penetrate a surface of the sterilized fluid path 240 , penetration needle barrier 252 , and a surface of the sterilized container holder 227 after the container holder barrier 251 is removed.
- the sterilized penetration needle 241 may be inserted through a surface of the fluid path 240 that is adjacent or proximal to the sterilized penetration needle 241 and through the container holder barrier 251 , and into the sterilized container holder 227 .
- the container holder barrier 251 may be removed to avoid contamination associated with the outside of the container holder barrier 251 .
- the penetration by the penetration needle 241 may be a result of an electronic or mechanical force applied to the sterilized penetration needle 241 (e.g., via which the sterilized penetration needle 241 is pushed or pulled towards the sterilized container holder 227 ) and/or an electronic or mechanical force applied to the sterilized container holder 227 (e.g., via which the sterilized container holder is pushed or pulled towards the penetration needle 241 ).
- the sterilized user needle 243 is configured to penetrate a surface of the sterilized fluid path 240 and sterilized user needle barrier 253 .
- the sterilized user needle 243 may be inserted through a surface of the fluid path 240 that is distal from the sterilized penetration needle 241 and through the user needle barrier 253 .
- the penetration by the sterilized user needle 243 may be a result of an electronic or mechanical force applied to the sterilized user needle 243 (e.g., via which the sterilized user needle 243 is pushed or pulled towards user needle barrier 253 ) and/or an electronic or mechanical force applied in the direction from the user needle barrier 253 towards sterilized user needle 243 .
- FIG. 4B shows an implementation of the disclosed subject matter where the barrier(s) (i.e., container holder barrier 251 , penetration needle barrier 252 , and/or user needle barrier 253 ) are removed prior to penetration by the sterilized penetration needle 241 and/or sterilized user needle 243 .
- the barrier(s) may be removed by, for example, a user or may be removed automatically based on an electrical or mechanical movement, which causes removal of the barrier(s).
- a patch pump e.g., such as patch pump 100 of FIG. 1A - FIG. 1C
- One or more barriers may be removed at the same time or each barrier of the multiple barriers may be removed at different times.
- the sterilized penetration needle 241 may penetrate one or more sterilized fluid path 240 surfaces, and one or more surfaces of the sterilized container holder 227 and may be configured to provide solution contained in the sterilized container holder 227 into the sterilized channel 242 .
- the user needle may be configured to penetrate one or more sterilized fluid path 240 surfaces and may be configured to provide solution from the sterilized channel 242 to a user or other component(s) which then provide the solution to a user.
- FIG. 5 shows a process with components in accordance with an implementation disclosed herein.
- a container holder may be assembled at 501 and may include primary container 510 , container holder 511 , and container holder barrier 512 .
- the assembled container holder may be sterilized.
- the assembly 501 and/or sterilization may occur in a clean room, as disclosed herein.
- a solution 514 may be aseptically added to the primary container 510 , at 503 .
- the solution 514 may be sealed via a stopper 513 at 503 .
- components of a fluid path 520 along with a penetration needle barrier 521 may be assembled.
- the fluid path 520 and penetration needle barrier 521 may be sterilized at 505 .
- the assembly 504 and/or sterilization may occur in a clean room, as disclosed herein.
- the sterilized primary container 510 and/or container holder 511 assembled at step 503 may be manufactured and shipped at the same location and time or at a different location and time than the sterilized fluid path assembled at 505 .
- a delivery device 530 may be assembled at 507 and 508 such that a device component 531 , the sterilized primary container 510 , container holder 511 , container holder barrier 512 , fluid path 520 , and penetration needle barrier 521 may be assembled to provide a delivery device 530 .
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Abstract
Description
- This application is a divisional of U.S. patent application Ser. No. 16/295,818, filed on Mar. 7, 2019, which claims the benefit of U.S. Provisional Patent Application No. 62/640,421, filed on Mar. 8, 2018, the contents of which are hereby incorporated by reference herein.
- In medical devices such as combination patch pumps, which include a pump and a solution (e.g., drug), the solution, while inside the pump, cannot pass a sterilization process for a fluid path that transports the solution. Using an unsterilized fluid path can cause adverse effects such as infections and is unacceptable from a risk management perspective
- A device and method is disclosed for assembling a container holder in a clean environment, aseptically adding a solution to a primary container, inserting the primary container into the container holder, applying a first barrier to the container holder, sterilizing the container holder comprising the primary container and the applied first barrier to provide a sterilized container holder, assembling a fluid path module in a clean environment, the assembling comprising applying a second barrier to a first end of the sterilized fluid path module, sterilizing the fluid path module to provide a sterilized fluid path module and assembling a delivery device comprising the sterilized container holder and the sterilized fluid path module.
- A more detailed understanding may be had from the following description, given by way of example in conjunction with the accompanying drawings wherein:
-
FIG. 1A is a graphic depiction of a patch pump for a user. -
FIG. 1B is a graphic depiction of the outer casing of an example of a patch pump. -
FIG. 1C is a graphic depiction of an example of a patch pump with the outer casing removed. -
FIG. 2A is a graphical depiction of a container holder; -
FIG. 2B is a graphical depiction of primary container with solution, inserted into a container holder; -
FIG. 2C is a graphical depiction of a sterilized fluid path module; -
FIG. 2D is a graphical depiction of barriers associated with a sterilized container holder and fluid path; -
FIG. 3 is a graphical depiction of a sterilization process; and -
FIG. 4A is a graphical depiction of a penetration needle and a user needle penetrating barriers; -
FIG. 4B is a graphical depiction of a penetration needle and a user needle penetrating surfaces; and -
FIG. 5 is a graphical description of assembling a delivery device. - Examples of sterilized delivery device implementations will be described more fully hereinafter with reference to the accompanying drawings. These examples are not mutually exclusive, and features found in one example can be combined with features found in one or more other examples to achieve additional implementations. Accordingly, it will be understood that the examples shown in the accompanying drawings are provided for illustrative purposes only and they are not intended to limit the disclosure in any way. Like numbers refer to like elements throughout.
- Below are described an apparatus and methods for delivering solutions such as pharmaceutical drugs and/or biologics to a patient. The apparatus and methods may allow for prescription or standard off-the-shelf drug cartridges, vials, syringes, or other containers (hereinafter generally referred to as a container), to be utilized without compromising the sterility of the solution. This may enable a patient to self-administer a solution in a self-contained wearable patch pump form factor that is cost effective and comfortable to wear. The disclosure subject matter provided herein may allow the manufacturing and use of a drug delivery device that includes a sterilized fluid path and container holder.
-
FIGS. 1A-1C show an example delivery device is shown viapatch pump 100, which may be used with the sterilized container holder and sterilized fluid path as further described herein. A sterilized container holder may be provided in accordance with the subject matter disclosed herein. A delivery device may include such a sterilized container holder, which may connect to a sterilized container holder, in accordance with the subject matter disclosed herein. It will be understood, however, thatpatch pump 100 is an example, and other patch pumps or delivery devices may be used to implement a sterilized fluid path and sterilized container holder, as disclosed herein. -
FIG. 1A is a graphic depiction of apatch pump 100 on apatient 115. Thepatch pump 100 includes a base 125 that contacts the patient's skin. In some embodiments, thebase 125 includes an adhesive liner that affixes thepatch pump 100 to thepatient 115. Thepatch pump 100 may further include a userflow control switch 135. The userflow control switch 135 may enable a user to pause and control the flow rate of a solution. Thepatch pump 100 further includes astart button 105 that may be pressed by a user to cause a cannula and/or needle to be inserted into the patient and the solution to flow from adrug container 130 through the cannula and/or needle into the patient. - As shown in
FIG. 1B , thepatch pump 100 may further include adrug viewing window 145. This viewing window may enable a user to view the amount of a solution that remains in thedrug container 130. Thepatch pump 100 may also include one or morevisual indicators 155. Thevisual indicators 155 provide feedback on the operational status of the system. The operational status of the system may include warnings such as an over/under temperature warning, drug expiration warning and over/under pressure warning. In addition, the operational status may include information indicating that the drug is being administered, how much time is remaining for the drug dosage to be completed and the current flow rate. The visual indicators may include LEDS, LCD displays or other similar display technologies known in the art. The information that is displayed by visual indicators may also be wirelessly transmitted to a mobile computing device such as a smart phone utilizing any of the wireless communication methods known in the art. - The
patch pump 100 may further include aremovable safety 170. The removable safety mechanically engages thestart button 105 and prohibits thestart button 105 from being involuntary pressed. -
FIG. 1C shows additional components of apatch pump 100. Thepatch pump 100 may also include aneedle insertion component 185 that is mechanically connected to thestart button 105. In addition, thepatch pump 100 includes anelectronic circuit board 140 that includes control circuitry for thevisual indicators 155, userflow control switch 135 and apressurization system 150. In addition, theelectronic circuit board 140 may be communicatively connected to one or more sensors. These sensors may includepressure sensor 165 andproximity sensor 175 or any other applicable sensor such as a haptic feedback sensor (not shown) or other indicator. Theelectronic circuit board 140 may also include amemory 190. Thememory 190 may store dosing instructions for the administration of the solution. In addition, thememory 190 may also store information regarding the administration of the solution. This information IT may include, time, date, and flow rate when the solution was administered. Theelectronic circuit board 140 may control thevisual indicators 155 and thepressurization system 150 based on the information stored in the memory and the feedback from the sensors. Theelectronic circuit board 140 may include a communication module that enables the transmission of information stored in thememory 190 to a wireless computing device. In addition, the communication module may also receive updated dosing instructions that are subsequently stored in thememory 190. - According to the implementations disclosed herein, a delivery device may be assembled such that a sterilized container holder and a sterilized fluid path are provided to operate the delivery device. The sterilized container holder and the sterilized fluid path may be assembled via two separate processes such that they may be provided as separately packaged components. By providing the sterilized container holder and the sterilized fluid path as separately packaged components, a user may be able to use combinations two or more different container holders (e.g., two or more different drugs) with different sterilized fluid path components. For example, a first sterilized container holder and a first sterilized fluid path may be used in conjunction with a patch pump at a first time. Subsequently, a second sterilized container holder with a different drug than the first sterilized container holder and a second sterilized fluid path that is similar to the first sterilized fluid path may be provided. For example, multiple sterilized fluid path components may be bought as a pack of two or more sterilized fluid path components such that they can be used with different drugs via different sterilized container holders.
- As disclosed herein, a septic process may be used when transferring or handling a solution (e.g., a drug) and a sterilization process may apply to components where the transfer or contamination of a solution is not applicable.
- A sterilized container holder may be assembled such that a non-sterilized container holder may be provided in a clean environment. A clean environment may be, for example, an ISO certified clean room. The container holder may go through a sterilization process either inside or outside the clean environment. A solution, such as a drug, may be inserted into a primary container, inside a septic environment. The primary container may be a sterilized primary container. The solution may be inserted into the primary container via an aseptic filling technique. The aseptically filled primary container containing the solution may then be stoppered to seal the solution inside of the primary container, resulting in an overall aseptic insertion of the solution into the primary container. The stoppered primary container with the aseptically filled solution may be inserted into the container holder after the container holder is sterilized, resulting in a sterilized container holder with a primary container including a solution. The sterilized container holder may include a barrier, as further disclosed herein, that seals the sterilized container holder such that the sterilized container holder maintains its sterilization.
- A sterilized fluid path may be assembled in a clean room. The fluid path may include a penetration needle, a channel via which the solution traverses, and a user needle configured to insert into a user or into a cannula to provide the solution to a user. The penetration needle may, as further disclosed herein, receive and/or draw solution from a primary container. The channel may be a line, pipe, hose, or other mode to transport fluid from at least the penetration needle to the user needle. The user needle may be configured to insert into a user or to provide fluid to a cannula or other needle that provides the solution to a user. As used herein, the sterilized fluid path and/or fluid path may also include a drive module. The drive module may be configured to cause the solution to be driven from the primary container, through the sterilized fluid path, and to a user. The sterilized fluid pathway may include one or two barriers, as further disclosed herein, that seal the sterilized fluid path such that the sterilized fluid path maintains its sterilization. A first such barrier may be on the end where the penetration needle is located and a second such barrier may be on the end where the user needle is located.
- As described herein, a clean environment may be a clean room or other environment that meets a given standard. Clean rooms may be classified according to the cleanliness level of the air inside them. The clean room class may correspond to the level of cleanliness the room complies with, according to the quantity and size of particles per volume of air. The primary authority in the US and Canada is the ISO classification system ISO 14644-1, though it will be understood that the clean environment disclosed herein is not limited to the ISO classification. This standard includes the cleanroom classes ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9, with ISO 1 being the “cleanest” and ISO 9 the “dirtiest” class (but still cleaner than a regular room). The most common classes are ISO 7 and ISO 8.
-
FIG. 2A shows anempty container holder 211sterilization process 210. Theempty container holder 211 may be assembled, manufactured, prepared or otherwise provided in a clean environment such as an ISO certified clean room (e.g., ISO 8), as disclosed herein. During thesterilization process 210, the container holder may be handled or otherwise manipulated by a robotic arm or other machine, or may be handled or otherwise manipulated by a user. As shown, theempty container holder 211 may experience sterilization at 212 such that the container holder may be sterilized to remove particles, dust, bacteria, contaminants, or other components that are not desirable. -
FIG. 2B shows aclean assembly 220 during whichsolution 221 is aseptically inserted and stored in aprimary container 222, stoppered, and inserted into a sterilizedcontainer holder 227. Thecontainer holder 227 may be assembled, manufactured, prepared or otherwise provided in a clean environment such as an ISO certified clean room (e.g., ISO 5), as disclosed herein. As shown, asolution 221 may be inserted intoprimary container 222 via anaseptic filling 223. Aseptic filling 223 may also include sterilization of thesolution 221, sterilization of theprimary container 222, and conservation of sterility during the filling. Equipment and packaging materials used during theaseptic filing 223 may be sterilized with various medium or combination of mediums such as via saturated steam, superheated steam, hydrogen peroxide, heat, and/or other treatments. - As shown in
FIG. 2B , astopper 226 may be applied to an aseptically filledprimary container 224 at thestoppering step 225. The stopperingstep 225 may include applying thestopper 226 to the aseptically filledprimary container 224 via any applicable technique such as forced or mechanical stoppering such that thestopper 226 seals thesolution 221 inside the aseptically filledprimary container 224. - The sterilized
container 211 ofFIG. 2A may be provided such that the stoppered aseptically filledprimary container 224 is inserted into theempty container holder 211 to provide a sterilizedcontainer holder 227. The aseptically filledprimary container 224 may be inserted into theempty container holder 211 in a clean environment, which may be the same as or different from the clean environment in which thesolution 221 is aseptically filled into theprimary container 222. As further disclosed herein, a barrier may be applied to the sterilizedcontainer holder 227. -
FIG. 2C shows apenetration needle 231, achannel 232, and auser needle 233 such that thechannel 232 connects thepenetration needle 231 to theuser needle 233. As disclosed herein, thepenetration needle 231 is configured to puncture a primary container (e.g., aseptically filledprimary container 224 ofFIG. 2B ) inside a container holder (e.g., the sterilizedcontainer holder 227 ofFIG. 2B ) such that solution (e.g.,solution 221 ofFIG. 2B ) is provided to thechannel 232 and to a user via theuser needle 233. - The
fluid path module 230 may includedrive module 234,penetration needle 231,channel 232, anduser needle 233 that are assembled, manufactured, prepared or otherwise provided in a clean environment such as an ISO certified clean room (e.g., ISO 7), as disclosed herein. Thedrive module 234 may include components that cause a solution to be inserted into and/or traverse through thefluid path module 230 and, specifically, via thepenetration needle 231,channel 232, anduser needle 233. The device module may include on or more electronic components, mechanical components, or a combination of the same. According to an implementation, adrive module 234 may not be provided such that a patch pump, patch pump component(s), or other component may substitute for the functionality provided by thedrive module 234. - The
fluid path module 230 may experience sterilization, to provide a serializedfluid path module 240, such that the components of thefluid path module 230 including thepenetration needle 231,channel 232,user needle 233 and drivemodule 234 are sterilized to remove particles, dust, bacteria, contaminants, or other components that are not desirable. As shown, the sterilizedfluid path module 240 may include a sterilizedpenetration 241, a sterilizedchannel 242, sterilizeduser needle 243 and sterilizeddrive module 244. The sterilizedfluid path module 240 may be sealed or otherwise treated to mitigate contamination. - As shown in
FIG. 2D , adelivery device 250 may be assembled and may include the sterilizedcontainer holder 227 and a sterilizedfluid path 240 including sterilizedpenetration 241, a sterilizedchannel 242, and sterilizeduser needle 243. Thedelivery device 250 may be a standalone device or may be configured to incorporate the sterilizedcontainer holder 227 and sterilizedfluid path 240 into its operation. For example, thedelivery device 250 may bepatch pump 100 ofFIG. 1A -FIG. 1C , a different patch pump or a different device configured to provide a solution. - As shown in
FIG. 2D , one or more barriers may be applied to the sterilizedcontainer holder 227 and/or sterilizedfluid path 240. Acontainer holder barrier 251 may be applied to thecontainer holder 227. Apenetration needle barrier 252 may be applied to a first end of the sterilized fluid path 240 (e.g., on the end closest to the sterilized penetration needle 241). Auser needle barrier 253 may be applied to a second end of the sterilizedfluid path 240. Thebarriers barriers respective barrier barriers -
FIG. 3 shows a complete diagram including the components and steps provided inFIG. 2A-D . As shown, at 210, an emptyprimary container 211 is provided in a clean environment and is sterilized at 212. Asolution 221 is aseptically inserted, at 223, into aprimary container 222. Theprimary container 222 is filled with thesolution 221 and is stoppered 225 viastopper 226. The stoppered and aseptically filedprimary container 224 is placed inside the container holder (after sterilization 212) such that a sterilizedcontainer holder 227 includes aprimary container 224 including thesolution 221. - A
penetration needle 231,channel 232, anduser needle 233 is assembled with adrive module 234 and sterilized in a clean environment to result in a sterilizedfluid path 240 that includes a sterilizedpenetration needle 241, sterilizedchannel 242, sterilizeduser needle 243 and sterilizeddrive module 244. - A
delivery device 250 includes the sterilizedcontainer holder 227 and sterilizedfluid path 240 as well ascontainer holder barrier 251 attached to the sterilizedcontainer holder 227,penetration needle barrier 252 attached to a first end of the sterilizedfluid path 240 near the sterilizedpenetration needle 241, and auser needle barrier 253 attached to a second end of the sterilizedfluid path 240 near the sterilizeduser needle 243. - The barrier(s) (i.e.,
container holder barrier 251,penetration needle barrier 252, and/or user needle barrier 253) may be configured to seal the components that they are attached to and may further be configured to maintain the sterility of a component that they are attached to. For example, thecontainer holder barrier 251 may be configured to seal the sterilizedcontainer holder 227 such that the sterility of the sterilizedcontainer holder 227 is maintained as a result of seal provided by thecontainer holder barrier 251. - It should be noted that the sterilized
container holder 227 and the sterilizedfluid path 240 may be manufactured and/or shipped at the same time or may be manufactured/and or shipped as separately packaged items. Such flexibility may reduce cost and allow separate uses of the sterilizedcontainer holder 227 and the sterilizedfluid path 240. -
FIG. 4A shows an implementation of the disclosed subject matter where thepenetration needle 241 is configured to penetrate a surface of the sterilizedfluid path 240,penetration needle barrier 252, and a surface of the sterilizedcontainer holder 227 after thecontainer holder barrier 251 is removed. As shown, the sterilizedpenetration needle 241 may be inserted through a surface of thefluid path 240 that is adjacent or proximal to the sterilizedpenetration needle 241 and through thecontainer holder barrier 251, and into the sterilizedcontainer holder 227. Note that thecontainer holder barrier 251 may be removed to avoid contamination associated with the outside of thecontainer holder barrier 251. The penetration by thepenetration needle 241 may be a result of an electronic or mechanical force applied to the sterilized penetration needle 241 (e.g., via which the sterilizedpenetration needle 241 is pushed or pulled towards the sterilized container holder 227) and/or an electronic or mechanical force applied to the sterilized container holder 227 (e.g., via which the sterilized container holder is pushed or pulled towards the penetration needle 241). - According to the implementation shown in
FIG. 4A , the sterilizeduser needle 243 is configured to penetrate a surface of the sterilizedfluid path 240 and sterilizeduser needle barrier 253. As shown, the sterilizeduser needle 243 may be inserted through a surface of thefluid path 240 that is distal from the sterilizedpenetration needle 241 and through theuser needle barrier 253. The penetration by the sterilizeduser needle 243 may be a result of an electronic or mechanical force applied to the sterilized user needle 243 (e.g., via which the sterilizeduser needle 243 is pushed or pulled towards user needle barrier 253) and/or an electronic or mechanical force applied in the direction from theuser needle barrier 253 towards sterilizeduser needle 243. -
FIG. 4B shows an implementation of the disclosed subject matter where the barrier(s) (i.e.,container holder barrier 251,penetration needle barrier 252, and/or user needle barrier 253) are removed prior to penetration by the sterilizedpenetration needle 241 and/or sterilizeduser needle 243. The barrier(s) may be removed by, for example, a user or may be removed automatically based on an electrical or mechanical movement, which causes removal of the barrier(s). For example, a patch pump (e.g., such aspatch pump 100 ofFIG. 1A -FIG. 1C ) may include mechanisms to remove barriers such as thecontainer holder barrier 251,penetration needle barrier 252, and/oruser needle barrier 253. One or more barriers may be removed at the same time or each barrier of the multiple barriers may be removed at different times. - According to the implementation shown in
FIG. 4B , the sterilizedpenetration needle 241 may penetrate one or more sterilizedfluid path 240 surfaces, and one or more surfaces of the sterilizedcontainer holder 227 and may be configured to provide solution contained in the sterilizedcontainer holder 227 into the sterilizedchannel 242. The user needle may be configured to penetrate one or more sterilizedfluid path 240 surfaces and may be configured to provide solution from the sterilizedchannel 242 to a user or other component(s) which then provide the solution to a user. -
FIG. 5 shows a process with components in accordance with an implementation disclosed herein. As shown, a container holder may be assembled at 501 and may includeprimary container 510,container holder 511, andcontainer holder barrier 512. At 502, the assembled container holder may be sterilized. Theassembly 501 and/or sterilization may occur in a clean room, as disclosed herein. Asolution 514 may be aseptically added to theprimary container 510, at 503. Thesolution 514 may be sealed via astopper 513 at 503. - As shown at 504 in
FIG. 5 , components of afluid path 520 along with apenetration needle barrier 521 may be assembled. Thefluid path 520 andpenetration needle barrier 521 may be sterilized at 505. Theassembly 504 and/or sterilization may occur in a clean room, as disclosed herein. - As noted herein, the sterilized
primary container 510 and/orcontainer holder 511 assembled atstep 503 may be manufactured and shipped at the same location and time or at a different location and time than the sterilized fluid path assembled at 505. - A
delivery device 530 may be assembled at 507 and 508 such that adevice component 531, the sterilizedprimary container 510,container holder 511,container holder barrier 512,fluid path 520, andpenetration needle barrier 521 may be assembled to provide adelivery device 530. - Although features and elements are described above in particular combinations, one of ordinary skill in the art will appreciate that each feature or element can be used alone or in any combination with the other features and elements.
Claims (8)
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ES2919934T3 (en) | 2017-05-05 | 2022-07-29 | Regeneron Pharma | Autoinjector and related procedures for use |
EP3545997A1 (en) | 2018-03-27 | 2019-10-02 | Tecpharma Licensing AG | Patch delivery device with skin contact sensor |
EP3539592A1 (en) * | 2018-03-15 | 2019-09-18 | Tecpharma Licensing AG | An injection or infusion device comprising an improved housing and release liner for removing sterile barrier films using the release liner |
EP4059539A1 (en) * | 2021-03-15 | 2022-09-21 | Sensile Medical AG | Method of producing a drug delivery device |
USD1007676S1 (en) | 2021-11-16 | 2023-12-12 | Regeneron Pharmaceuticals, Inc. | Wearable autoinjector |
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- 2019-03-08 CN CN201980024247.8A patent/CN112955191A/en active Pending
- 2019-03-08 WO PCT/IB2019/051910 patent/WO2019171348A2/en active Application Filing
- 2019-03-08 EP EP19716557.4A patent/EP3762044A2/en active Pending
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CN112955191A (en) | 2021-06-11 |
US20190274924A1 (en) | 2019-09-12 |
EP3762044A2 (en) | 2021-01-13 |
WO2019171348A3 (en) | 2019-12-05 |
US11058605B2 (en) | 2021-07-13 |
WO2019171348A2 (en) | 2019-09-12 |
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