AU2025200064B1 - High-Efficiency Elastomer Diaphragm Fluid Delivery System for Accurate Medication Administration - Google Patents
High-Efficiency Elastomer Diaphragm Fluid Delivery System for Accurate Medication AdministrationInfo
- Publication number
- AU2025200064B1 AU2025200064B1 AU2025200064A AU2025200064A AU2025200064B1 AU 2025200064 B1 AU2025200064 B1 AU 2025200064B1 AU 2025200064 A AU2025200064 A AU 2025200064A AU 2025200064 A AU2025200064 A AU 2025200064A AU 2025200064 B1 AU2025200064 B1 AU 2025200064B1
- Authority
- AU
- Australia
- Prior art keywords
- medicament
- diaphragm
- needle
- reservoir
- elastomer diaphragm
- 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.)
- Active
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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
- A61M5/14212—Pumping with an aspiration and an expulsion action
- A61M5/14224—Diaphragm type
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
- A61M5/14593—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm the diaphragm being actuated by fluid pressure
-
- 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
- A61M2005/14252—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 needle insertion means
-
- 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
- A61M2005/14272—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body for emergency, field or home use, e.g. self-contained kits to be carried by the doctor
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/332—Force measuring means
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3546—Range
- A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8206—Internal energy supply devices battery-operated
-
- 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
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- 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
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16877—Adjusting flow; Devices for setting a flow rate
-
- 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
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
Landscapes
- Health & Medical Sciences (AREA)
- Hematology (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Physics & Mathematics (AREA)
- Fluid Mechanics (AREA)
- Dermatology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
#$%^&*AU2025200064B120250918.pdf#####
1.0 ABSTRACT
The present invention pertains to a high-efficiency fluid delivery system designed for precise,
dependable, and simultaneous large-volume subcutaneous medication administration,
particularly suitable for disposable and portable medical applications. Central to the invention
is an advanced elastomer diaphragm mechanism integrated with a diaphragm air pump, air
pressure distribution system, and a pressure-building chamber. These components are adapted
to ensure consistent pressure application for accurate medicament delivery while facilitating
safety and user adaptability.
The device features a modular design comprising a reservoir for storing medicaments, a port
connection for source integration, and a needle assembly configured to move between
retracted and extended positions. An adhesive layer facilitates secure mounting on the user’s
skin, while a stepper motor-driven actuation mechanism enables controlled needle movement.
The system incorporates a sophisticated drive mechanism operatively coupled to an
electronic pump, enabling the elastomer diaphragm to stretch and return to its original form
for controlled fluid displacement. Integrated sensors, adapted to measure tissue resistance,
adjust the flow rate to ensure optimal subcutaneous medicament delivery, including
simultaneous and large-volume administration. A controller provides enhanced functionality
by managing operations and offering user feedback through indicators.
In one embodiment, the invention represents a significant advancement in medication
administration, combining precision, safety, and ease of use through the innovative elastomer
diaphragm mechanism, advanced pressure management, and modular integration for
healthcare applications.
1.0 ABSTRACT
The present invention pertains to a high-efficiency fluid delivery system designed for precise,
dependable, and simultaneous large-volume subcutaneous medication administration,
particularly suitable for disposable and portable medical applications. Central to the invention
is an advanced elastomer diaphragm mechanism integrated with a diaphragm air pump, air
pressure distribution system, and a pressure-building chamber. These components are adapted
to ensure consistent pressure application for accurate medicament delivery while facilitating
safety and user adaptability.
The device features a modular design comprising a reservoir for storing medicaments, a port
connection for source integration, and a needle assembly configured to move between
retracted and extended positions. An adhesive layer facilitates secure mounting on the user's
skin, while a stepper motor-driven actuation mechanism enables controlled needle movement.
The system incorporates a sophisticated drive mechanism operatively coupled to an
electronic pump, enabling the elastomer diaphragm to stretch and return to its original form
for controlled fluid displacement. Integrated sensors, adapted to measure tissue resistance,
adjust the flow rate to ensure optimal subcutaneous medicament delivery, including
simultaneous and large-volume administration. A controller provides enhanced functionality
by managing operations and offering user feedback through indicators.
In one embodiment, the invention represents a significant advancement in medication
administration, combining precision, safety, and ease of use through the innovative elastomer
diaphragm mechanism, advanced pressure management, and modular integration for
healthcare applications.
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Description
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High-Efficiency Elastomer High-Efficiency Elastomer Diaphragm Diaphragm Fluid Fluid DeliverySystem Delivery System for for Accurate Medication Accurate MedicationAdministration Administration
TECHNICAL FIELD TECHNICAL FIELD The present disclosure pertains to the field of medical devices, specifically to fluid The present disclosure pertains to the field of medical devices, specifically to fluid
delivery delivery systems for precise systems for precise and/or and/or accurate accurate subcutaneous andlarge-volume subcutaneous and large-volume 2025200064
medicationadministration. medication administration. The Thepresent presentdisclosure disclosureparticularly particularly relates relates to tosuch such systems systems comprisingananon-body comprising on-bodyauto-injector. auto-injector.
BACKGROUND BACKGROUND Large-volumeon-body Large-volume on-body auto-injection auto-injection devices devices areare configured configured to to delivermedications deliver medications or or biologics that require volumes exceeding typical syringe capacities, such as high- biologics that require volumes exceeding typical syringe capacities, such as high-
viscosity drugs or long-duration infusions. viscosity drugs or long-duration infusions.
Thedisclosed The disclosed technology technologybelongs belongstotothe thefield field of of medical devices and medical devices anddrug drugdelivery delivery systems, particularly wearable systems, particularly wearable technologies designedto technologies designed to administer administer therapeutic therapeutic substances that require substances that require large largevolumes (generally greater volumes (generally greater than than 11 mL) over an mL) over an extended extended period period
Specifically, Specifically, some disclosed embodiments some disclosed embodiments pertaintotoon-body pertain on-body auto-injectiondevices auto-injection devices capable of delivering capable of delivering large-volume medicationssubcutaneously large-volume medications subcutaneously in in a a controlled, controlled, comfortable, and comfortable, anduser-friendly user-friendly manner. manner.These Thesedevices devicesaddress addresschallenges challengesassociated associated withthe with theadministration administration of high-viscosity of high-viscosity biologics, biologics, such assuch as monoclonal monoclonal antibodies,antibodies,
immunotherapies, immunotherapies, andandchemotherapy chemotherapy agents. agents.
Applications for Applications for such devices include: such devices include: • Biologics and Biologics andMonoclonal Monoclonal Antibodies: Antibodies: Medications Medications for conditions for conditions like like rheumatoidarthritis, rheumatoid arthritis, multiple multiple sclerosis, sclerosis,and and oncology often require oncology often require large large volumes. volumes. • Immunotherapy: Immunotherapy: Delivery Delivery of of drugs drugs like like checkpoint checkpoint inhibitors inhibitors or or cytokines. cytokines. • HormonalTherapies: Hormonal Therapies: Long-acting Long-acting injectable injectable hormones hormones for conditions for conditions such such as as endocrine disorders. endocrine disorders. • ChronicConditions: Chronic Conditions:Such Such as as heart heart failure,where failure, where medications medications likelike diuretics diuretics mayneed may needcontrolled controlledinfusion. infusion. • Chemotherapy: Allows Chemotherapy: Allows patients patients to to receive receive treatment treatment at home at home rather rather thanthan in ain a clinical setting. clinical setting.
Some disclosedembodiments Some disclosed embodimentscan can address address limitations limitations in existing in existing drug drug delivery delivery methods methods by enabling by enablingthe the administration administrationof of large large volumes volumeswithout withoutrequiring requiringclinical clinicalsupervision, supervision, reducing patient reducing patient burden, and/or improving burden, and/or improvingadherence adherencetototreatment treatmentregimens. regimens.
Thefollowing The followingare areknown known challenges challenges relatingtotodrug relating drugdelivery deliverysystems: systems: 1. HighViscosity: 1. High Viscosity: Large-volumemedications Large-volume medications often often have have higher higher viscosities,making viscosities, making conventional conventional syringes syringes or or auto-injectors auto-injectorsimpractical. impractical.Advanced mechanicaloror Advanced mechanical
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electromechanical systemsensure electromechanical systems ensuresmooth, smooth, pain-freedelivery. pain-free delivery. 2. Extended 2. ExtendedInjection InjectionTimes: Times: Delivering large Delivering large volumes may volumes may requireslower require slower infusionrates infusion ratestotominimize minimize discomfort. These discomfort. Thesedevices devicesoften oftenuse use programmable programmable mechanisms mechanisms for controlled for controlled delivery over delivery over 15–60 minutesororlonger. 15-60 minutes longer. 3. Patient 3. Patient Comfort: Comfort: Innovations like Innovations like ergonomic designs,adhesive ergonomic designs, adhesivepatches, patches,and andautomated automated needle needle 2025200064
insertion reducediscomfort insertion reduce discomfort and fear and fear of injections. of injections.
4. Adherence and Convenience: 4. Adherence and Convenience: Patients can Patients can administer administer medication medication at at home withoutmedical home without medical supervision, supervision, improving adherenceandand improving adherence reducing reducing healthcare healthcare costs. costs. 5. Integration with 5. Integration with Smart SmartTechnologies: Technologies: Devicesincreasingly Devices increasingly incorporate incorporate connectivity connectivity features, features, such such as as Bluetooth, Bluetooth, enabling real-time monitoring, enabling real-time dosagetracking, monitoring, dosage tracking, and and communication communication with with healthcareproviders. healthcare providers.
Large-volumeon-body Large-volume on-body auto auto injectors injectors generally generally have have thethe following following features: features: 1. HighViscosity 1. High ViscosityInjection InjectionMechanism: Mechanism: Large-volumemedications Large-volume medications often often havehave higher higher viscosities,making viscosities, making conventional conventional syringes or syringes or auto-injectors auto-injectorsimpractical. impractical.Advanced mechanicaloror Advanced mechanical electromechanicalsystems electromechanical systemsensure ensuresmooth, smooth, pain-freedelivery. pain-free delivery. 2. Extended 2. ExtendedInjection InjectionTimes: Times: Delivering large Delivering large volumes volumes maymay requireslower require slower infusionrates infusion ratestotominimize minimize discomfort. These devices often use programmable mechanismscontrolled discomfort. These devices often use programmable mechanisms for for controlled delivery over delivery over 15–60 minutesororlonger. 15-60 minutes longer. 3. Adherence 3. Adherence and and Convenience: Convenience: Patients can Patients can administer administer medication medication at at home withoutmedical home without medical supervision, supervision, improvingadherence improving adherenceandand reducing reducing healthcare healthcare costs. costs. 4. Capacity 4. Capacityofofdelivering deliveringvolumes volumesranging ranging from from 3 mL 3 mL to 75to mL 75 or mLmore. or more. 5. Automaticadaptation 5. Automatic adaptationtotoinjection injectionsitesite back pressure to back pressure to minimize infusion minimize infusion
site leakage. site leakage.
6. Adjustable 6. Adjustableneedle needlesizes sizes(4 (4 mm, mm,6 6mm,mm, andand 8 mm) 8 mm) to meet to meet diverse diverse useruser requirements. requirements. 7. Customizable 7. Customizable pressure pressure settingstotoaccommodate settings accommodate users users of varying of varying age,age, size,andand size, body type, including infants, adults, and obese individuals. body type, including infants, adults, and obese individuals.
8. Closed-loopcontrol 8. Closed-loop controlsystem systemproviding providing precisefeedback precise feedback andand fullcontrol full control overthe over theinjection injectionprocess. process. 9. Delivery 9. Delivery Mechanisms: Mechanisms: o Elastomer Elastomer withwithmicro-pumps micro-pumps forfor precise precise control. control. 10. 10. Power Sources: Power Sources: o Battery-powered Battery-powereddevicesdevicesfor forprogrammable programmable delivery. delivery. 11. Needle Design: 11. Needle Design: o Retractable Retractableororhidden hidden needles needles for patient for patient safety. safety.
o Ultra-fine Ultra-fine needles needles to to minimize minimize painpain during during extended extendedinfusion. infusion. 12. 12. Connectivity Features: Connectivity Features: Integration with Integration with mobile apps or mobile apps or healthcare healthcare platforms platforms for for tracking tracking and and remote remote
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monitoring. monitoring.
The disclosed subject matter may address issues inherent in traditional syringe-based The disclosed subject matter may address issues inherent in traditional syringe-based
systems throughinnovative systems through innovativedesign designand andfunctionality. functionality. Below Belowisisaadetailed detailed analysis analysis of of problems associated with traditional systems, supported by relevant references. problems associated with traditional systems, supported by relevant references.
1. 1. Inconsistent InconsistentFlow Flow Rates Rates 2025200064
Problem:Irregular Problem: Irregular flow flowrates rates in in traditional traditional systems, systems, such as piston such as piston syringes, syringes, arise duetotomechanical arise due mechanical inefficiencies inefficiencies likestick-slip like the the stick-slip effect effect or or inadequate inadequate
pistoncontrol. piston control. o Impact: Dosing Impact: Dosing inaccuracies, inaccuracies, particularly particularly critical critical for subcutaneous for subcutaneous and and large-volume medicationdelivery. large-volume medication delivery. o Reference: Reference: Mark MarkSL,SL,etetal. al. (2024). (2024). "Assessing “AssessingSyringe Syringe'Stiction': ‘Stiction’: Clinical Impact Clinical of Plunger Impact of Resistance on Plunger Resistance onFlow FlowAccuracy." Accuracy.” Journal Journal of of Infusion Nursing, Infusion 47(1): 12-19. Nursing, 47(1): 12–19.
2. User 2. User Safety Safety Concerns Concerns Problem:Poor Problem: Poorsealing sealingororair airleakage leakageininsyringes syringesincreases increasesrisks riskslike like contamination, air embolism, contamination, air embolism, ororunderdosing. underdosing. o Impact: Threatens Impact: Threatens patient patient safety safety and reduces and reduces treatment treatment efficacy.efficacy.
o Reference: Sahasrabudhe V, et al. (2022). “Assessing Reference: Sahasrabudhe V, et al. (2022). "Assessing thethe Risk Risk of of Backflowand Backflow andCross-Contamination Cross-Contamination in Multi-Port in Multi-Port IV Access IV Access with with Syringe Injections.” Journal Syringe Injections." Journal ofof Hospital Hospital Infection, Infection,127: 127:121–127. 121-127.
3. 3. Challenges with Viscous Challenges with ViscousFluids Fluids Problem:High-viscosity Problem: High-viscositymedications medications deform deform or damage or damage traditional traditional syringe syringe barrels under barrels underpressure. pressure. o Impact: Impact:Limits Limits usability usability for for certain certain drugdrug formulations. formulations.
o Reference: Reference: FDA FDA Safety Safety Communication Communication (2023).(2023). “Potential "Potential Inaccuracies Inaccuracies with Certain Syringes in High-Pressure Infusion Settings.” Availableat: with Certain Syringes in High-Pressure Infusion Settings." Available at: FDA.gov. FDA.gov.
4. Retention 4. Retention of of Residual Residual Liquid Liquid Problem: Residual liquid adheres to syringe barrels, leading to wastage. Problem: Residual liquid adheres to syringe barrels, leading to wastage.
o Impact: Results Impact: Results in in inefficiency inefficiency and and economic economic loss, especially loss, especially for costly for costly
drugs. drugs.
5. 5. Air Air Leakage Leakage Problem:Air Problem: Airgaps gapsbetween between pistonsand pistons and barrelscompromise barrels compromise vacuum vacuum sealsseals during aspiration,introducing during aspiration, introducing bubbles. bubbles.
o Impact: Impact: Reduces Reducesinjection injectionaccuracy accuracyand andposes posesembolism embolism risks. risks. o Reference: Reference: Sahasrabudhe Sahasrabudhe V,V,etet al. (2022). al. (2022).
6. 6. Increased Increased Dead Space Dead Space Problem: Traditional Problem: Traditional syringe syringe designs designs result result in unrecoverable in unrecoverable liquidintrapped in liquid trapped
dead space. dead space. o Impact: Impact: Causes Causessignificant significant medication medicationwastage. wastage.
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7. 7. Material Material Incompatibility Incompatibility Problem:Syringe Problem: Syringematerials materialsmay may failunder fail undervarying varyingthermal thermalorormechanical mechanical conditions. conditions.
o Impact: Reducesreliability Impact: Reduces reliability in in diverse diverse environments. environments.
8. 8. Failure Failure in inHigh-Pressure High-Pressure Applications Applications Problem: High-pressurerequirements Problem: High-pressure requirements forfor viscous viscous medications medications cause cause leakage, leakage, 2025200064
deformation, deformation, or or breakage breakage in traditional in traditional syringes. syringes.
o Impact: Impact: Reduces Reducessystem system reliability. reliability. o Reference: Reference: FDA FDA Safety Safety Communication Communication (2023). (2023).
9. Difficulty with Aspiration 9. Difficulty with Aspiration
Problem:Poor Problem: Poorpiston pistondesign designinintraditional traditional systems complicatesaspiration. systems complicates aspiration. o Impact: Impact: Reduces Reducesaccuracy accuracyininprocedures procedures requiringprecise requiring preciseliquid liquid handling. handling.
10. Stick-SlipEffect 10. Stick-Slip Effect Problem:Irregular Problem: Irregular piston piston movement disruptsdosing movement disrupts dosing precision. precision. o Impact: Impact: Compromises Compromises control control over over medication medication delivery. delivery. o Reference: Reference: Mark MarkSL,SL,etetal. al. (2024). (2024).
11. 11. Improper Fit Improper Fit Problem:Mismatches Problem: Mismatches between between pistons pistons and and barrels barrels lead lead to to leakage leakage or or excessive excessive friction. friction.
o Impact: Impact: Reduces Reducessystem system reliability. reliability.
Theelastomer The elastomerdiaphragm diaphragm fluiddelivery fluid deliverysystem system described described below below maymay innovatively innovatively address the address the shortcomings oftraditional shortcomings of traditional medication delivery systems. medication delivery systems. By Byoffering offering solutions tochallenges solutions to challenges such such as inconsistent as inconsistent flow rates, flow rates, user safety user safety concerns, concerns, high- high- pressureapplications, pressure applications,andand residual residual liquid liquid retention, retention, embodiments embodiments of the invention of the invention
establish establish aanew newstandard standard for for precision, precision, safety, safety, and efficiency and efficiency in drugin drug delivery. delivery.
Current solutions for Current solutions for on-body large-volumesubcutaneous on-body large-volume subcutaneous injectors(OBIs) injectors (OBIs) exhibit exhibit several limitations that hinder their effectiveness, patient comfort, and adaptability. several limitations that hinder their effectiveness, patient comfort, and adaptability.
Theselimitations, These limitations, documented documented in medical in medical literature literature andanalyses, and device device analyses, highlight the highlight the
need for need for significant significant advancements advancements in in design designandandfunctionality. functionality. Key challengesinclude: Key challenges include:
1. 1. High High Viscosity Viscosity Medication Delivery Medication Delivery Issue: Biologicsandand Issue: Biologics large-volume large-volume drugs drugs often often have have high high viscosity, viscosity, leading to:leading to: o Increased resistance during delivery. Increased resistance during delivery.
o Prolonged Prolongedinjection injection times. times. o Mechanical stress ondevice Mechanical stress on devicecomponents. components. Impact:Limits Impact: Limits OBIs' OBIs' suitability suitability for therapies for therapies like monoclonal like monoclonal antibodies antibodies and and chemotherapy. chemotherapy. Solution: Solution: Elastomer diaphragmsandand Elastomer diaphragms pressure-building pressure-building chambers chambers provide provide consistent pressure consistent pressure andand flow, flow, addressing addressing high-viscosity high-viscosity deliverydelivery challenges. challenges.
Reference: Sahasrabudhe Reference: Sahasrabudhe V, V,et et al.(2022). al. (2022)."Assessing “AssessingthetheRisk RiskofofBackflow Backflowand and
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Cross-Contamination Cross-Contamination in in Multi-Port Multi-Port IV IV Access Access withwith Syringe Syringe Injections.” Injections." Journal Journal of of Hospital Hospital Infection, Infection, 127: 127: 121–127. 121-127.
2. Extended 2. Injection Times Extended Injection Times Issue: Subcutaneous tissue's limited absorption capacity necessitates slow Issue: Subcutaneous tissue's limited absorption capacity necessitates slow
infusion rates(15-60 infusion rates (15–60 minutes minutes or longer), or longer), causing: causing:
o Discomfort Discomfortand andreduced reducedcompliance. compliance. o Site Site leakage leakage or or backflow. 2025200064
backflow. Impact: Diminishesthe Impact: Diminishes theconvenience convenience of of home-based home-based therapies. therapies. Solution: Solution: Programmable Programmable flow flow ratesand rates andfeedback feedback mechanisms mechanisms optimize optimize delivery times delivery times without compromising without compromising comfort comfort andand efficacy. efficacy. Reference: Gupta Reference: GuptaP,P,etet al. al. (2021). (2021). "Subcutaneous Infusionfor "Subcutaneous Infusion for Large-Volume Large-Volume Biologics: Challenges Biologics: Challenges andandInnovations." Innovations."Current CurrentDrug Drug Delivery, Delivery, 18(5):23-32. 18(5): 23–32.
3. 3. Patient Patient Discomfort and Limited Discomfort and LimitedUsability Usability Issue: Issue: Existing Existing OBIs often have OBIs often have non-ergonomic non-ergonomic designs, designs, fixedneedle fixed needle sizes,and sizes, and bulky forms, leading to: bulky forms, leading to:
o Pain Painduring duringneedle needle insertion. insertion.
o Poor Poorcompatibility compatibility for for diverse diverse populations populations (e.g., (e.g., paediatric, paediatric, elderly, elderly,
obese). obese). Impact: Reduces Impact: Reducespatient patientadherence adherencetototreatment treatmentregimens. regimens. Solution: Solution: Ergonomic designs(small) Ergonomic designs (small)with withadjustable adjustableneedle needlesizes sizesimprove improve patient comfort patient comfortandand usability. usability.
Reference:Mark Reference: Mark SL,al.et (2024). SL, et al. (2024). “Assessing "Assessing Syringe Syringe "Stiction":‘Stiction’: Clinical Clinical
Impact Impact ofof Plunger PlungerResistance ResistanceononFlow FlowAccuracy." Accuracy.” Journal Journal of of Infusion Infusion Nursing, Nursing, 47(1): 12–19. 47(1): 12-19.
4. Risk of Injection Site Leakage 4. Risk of Injection Site Leakage
Issue: Issue: Pressure Pressure generated generated during large-volumedelivery during large-volume deliverycan cancause causefluid fluid leakage leakage or swellingatatthe or swelling theinjection injection site. site.
Impact: Reducesdosing Impact: Reduces dosingaccuracy accuracy and and therapeutic therapeutic efficacy. efficacy. Solution: Real-time Solution: Real-time sensors sensors monitor monitor tissuetissue resistance resistance andflow and adjust adjust flow rates rates
dynamicallytotoprevent dynamically preventleakage. leakage. Reference: Moog Reference: Moog R, R, etetal. al. (2020). (2020). "Assessment "AssessmentofofInjection InjectionSite SiteLeakage Leakageinin Large-Volume Large-Volume Subcutaneous Subcutaneous Delivery." Delivery." Journal Journal of Pharmaceutical of Pharmaceutical Sciences, Sciences, 109(3): 109(3): 876–884. 876-884.
5. 5. Complexity Complexity inin Operation Operationand andLack Lack ofof Feedback Feedback Issue: Many OBIs lack intuitive controls or Issue: Many OBIs lack intuitive controls or feedback systems,leading feedback systems, leadingto: to: o User Usererrors errorsduring during operation. operation.
o Difficulty Difficultydetecting detecting issues issues (e.g., (e.g., blockages blockages or incomplete or incomplete injections). injections).
Impact: Increases Impact: Increases dependence dependenceononmedicalmedical supervision, supervision, reducing reducing effectiveness effectiveness for self-administration. for self-administration. Solution: Integrating Solution: Integrating tactileswitches, tactile switches, visual/auditory visual/auditory indicators, indicators, and app-based and app-based
interfaces interfaces simplifies simplifiesoperation operationand and enhances enhances user user confidence. confidence. Reference: Brown Reference: Brown A,A, etetal. al. (2023). (2023). "Simplifying "SimplifyingDrug DrugPreparation Preparationforfor WearableInjectors: Wearable Injectors: AAUser-Centric User-CentricApproach." Approach." Journal Journal of of Advanced Advanced Medical Medical
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Devices, 9(6): Devices, 9(6): 432–441. 432-441.
6. 6. Dead Spaceand Dead Space andMedication Medication Waste Waste Issue: Residualliquid Issue: Residual liquid often often remains remains indead in the the dead space space of of traditional traditional OBIs. OBIs. Impact: Leads to significant wastage of expensive biologics. Impact: Leads to significant wastage of expensive biologics. Solution: Solution: Elastomer diaphragmsminimize Elastomer diaphragms minimize residual residual liquid,ensuring liquid, ensuringmaximum maximum drug utilization. drug utilization. 2025200064
Reference: Kleinberg Reference: KleinbergM.M.(2021). (2021)."Dead "Dead Space Space Volume Volume and Medication and Medication Waste Waste in in Auto-Injectors." Auto-Injectors." Therapeutic Therapeutic Delivery, Delivery, 12(7): 12(7): 541–550. 541-550.
7. 7. Lack of Connectivity Lack of for Monitoring Connectivity for Monitoring Issue: Issue: Most OBIsdodonot Most OBIs notintegrate integrate with with modern modernhealthcare healthcaresystems, systems,limiting: limiting: o Real-time Real-time adherence adherencetracking. tracking. o Remote Remotemonitoring monitoring andand dosage dosage adjustments adjustments by providers. by providers. Impact:Reduces Impact: Reducesthe the ability ability to personalize to personalize treatment. treatment.
Solution: Solution: IoT-enabled designswith IoT-enabled designs withBluetooth Bluetoothconnectivity connectivitylink linkOBIs OBIstoto electronic electronic health health records records andand monitoring systems. monitoring systems. Reference: Wilson Reference: WilsonK,K,etetal.al. (2020). (2020). "The Roleof "The Role of IoT IoTin in Modern ModernSubcutaneous Subcutaneous DrugDelivery Drug DeliveryDevices." Devices."Internet InternetofofMedical MedicalThings Things Journal,12(5): Journal, 12(5):214-223. 214–223.
8. 8. Power andPortability Power and Portability Challenges Challenges Problem:OBIs Problem: OBIsrelying relyingononhigh-powered high-powered motors motors or bulky or bulky batteries batteries compromise compromise portability. portability.
Impact: Reducesconvenience Impact: Reduces convenience forfor home home and and mobile mobile use.use. Solution in Innovation: Lightweight, energy-efficient designs Solution in Innovation: Lightweight, energy-efficient designs tailored tailored for for disposableororportable disposable portable configurations. configurations.
Reference: Sanchez Reference: SanchezM,M,etetal. al. (2020). (2020). Health HealthEconomics Economics andand Therapeutics, Therapeutics, 10(3): 10(3): 218–224. 218-224.
9. Limited 9. LimitedVolume Volume Range Range Problem:Many Problem: Many OBIs OBIs are are designed designed for for fixed-volume fixed-volume delivery, delivery, typically typically up up to to 3–5 3-5 mL. mL. Impact: Incompatible Impact: Incompatiblewithwiththerapies therapiesrequiring requiring10-75 10–75mLmL doses. doses. Solution Solution inin Innovation: Innovation: Modular reservoir design Modular reservoir designsupports supportsadjustable adjustable doses, doses, catering todiverse catering to diversetherapeutic therapeutic needs. needs.
Reference:Patel Reference: Patel R, R, et et al.al. (2021). (2021). DrugDrug Design Design and Delivery and Delivery Insights, Insights, 14(3): 14(3): 187–201. 187-201.
10. 10. Patient Patient Comfort and Adherence Comfort and Adherence Problem:Large-volume Problem: Large-volume injections injections cancan be be uncomfortable uncomfortable due due to: to: o Needle Needlesize sizeandand insertion insertion depth. depth.
o Device Devicebulkiness bulkinessand andlimited limitedmobility mobilityduring duringuse. use. Impact:Affects Impact: Affects adherence adherence to therapy, to therapy, especially especially in pediatric in pediatric or geriatric or geriatric
populations. populations. Solution in Innovation: Solution in Innovation: Compact, lightweightdesigns, Compact, lightweight designs,adjustable adjustableneedle needlesizes, sizes, and ergonomicfeatures and ergonomic featuresreduce reducediscomfort discomfortandand improve improve usability. usability. Reference: Mark Reference: MarkSL,SL,etetal.al. (2024). (2024). Journal Journal of of Infusion Infusion Nursing, 47(1): 12–19. Nursing, 47(1): 12-19.
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Thesechallenges These challengeshighlight highlight the the limitations limitations of of existing existingOBIs OBIs and and underscore the need underscore the need for for innovative designs. innovative designs.
SUMMARY SUMMARY TheHigh-Efficiency The High-EfficiencyElastomer Elastomer Diaphragm Diaphragm Fluid Fluid Delivery Delivery System System introduces introduces a a 2025200064
groundbreaking approach groundbreaking approach to to subcutaneous subcutaneous andand large-volume large-volume medication medication administration administration through aa highly through highly advanced advancedon-body on-body injection(OBI) injection (OBI) device. device. This This innovative innovative system system integrates state-of-the-art pressure management, real-time sensor feedback, and aa integrates state-of-the-art pressure management, real-time sensor feedback, and modular,user-friendly modular, user-friendly design, design, addressing the growing addressing the demand growing demand forfor safe,precise, safe, precise,and and efficient delivery of medications, particularly in portable and disposable medical efficient delivery of medications, particularly in portable and disposable medical
applications. applications.
Thedisclosed The disclosedembodiments embodimentsmay may include include the following the following features: features:
1. 1.Elastomer ElastomerDiaphragm-Based Diaphragm-Based PressurePressureManagement Management • Consistent Consistent andand Precise Precise Delivery: Delivery: TheTheelastomer elastomerdiaphragm diaphragm ensures ensures smooth, smooth, controlled controlled fluid fluid movement movement bybydynamically dynamically adjusting adjusting to to pressurechanges. pressure changes. • Large Volume Accommodation: Designed to handle high medication volumes Large Volume Accommodation: Designed to handle high medication volumes seamlessly, with adaptive seamlessly, with adaptive stretching stretching to to maintain maintain precision precision and and minimize minimize wastage. wastage. 2. Integrated 2. Integrated Sensor Sensor Technology Technology • Real-Time Real-TimeMonitoring: Monitoring: Sensors Sensors continuously continuously track track tissue tissue resistance,internal resistance, internal pressure,and pressure, andflow flow rates, rates, ensuring ensuring safe safe and accurate and accurate administration. administration.
• Flow FlowOptimization: Optimization:Advanced Advanced force force sensors sensors prevent prevent site site leakage leakage and and maintain maintain optimal delivery optimal delivery rates. rates.
3. 3. Advanced Advanced Needle Needle Actuation ActuationMechanism Mechanism • Customizable Needle Customizable Needle Sizes:A A Sizes: stepper stepper motor-driven motor-driven needle needle assembly assembly supports supports a a range of range of needle sizes (4 needle sizes (4 mm, mm, 66 mm, mm,8 8mm) mm)forfor diverse diverse applications. applications. • Enhanced EnhancedSafety: Safety:Automatic Automatic retractionminimizes retraction minimizes thethe riskriskofofaccidental accidental injuries, improving user confidence and safety. injuries, improving user confidence and safety.
4. Smart 4. Controller and Smart Controller and Feedback FeedbackSystemSystem • Precise PreciseControl: Control: A microcontroller A microcontroller regulates regulates all operations, all operations, delivering delivering real- real- time adjustments time adjustmentsfor for consistent consistent performance. performance. • User-Friendly User-Friendly Alerts: Alerts: Integrated Integrated indicators indicators and alerts and alerts provideprovide updates updates on on status, completion, or errors for improved usability. status, completion, or errors for improved usability.
5. 5. Compact, Modular Compact, Modular Design Design
• Lightweightand Lightweight andDisposable: Disposable:Modular Modular components, components, including including the reservoir, the reservoir, diaphragm, diaphragm, andandneedle needleassembly, assembly,arearedesigned designed forsingle-use for single-useapplications, applications, ensuring hygieneand ensuring hygiene andconvenience. convenience. • Portability: Compact Portability: designsupports Compact design supportsat-home at-homeorormobile mobile use,enhancing use, enhancing accessibility for patients. accessibility for patients.
Thedisclosed The disclosedembodiments embodimentsmay may involve involve the following the following operational operational modes: modes:
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1. 1. Filling FillingMode Mode Theelastomer The elastomerdiaphragm diaphragm retractstotodraw retracts drawmedication medication from from an an external external vialinto vial intothe the reservoir, ensuring precise dosage preparation. reservoir, ensuring precise dosage preparation.
2. Delivery 2. Delivery Mode Mode Thediaphragm The diaphragmcompresses compresses to deliver to deliver medication medication accurately accurately andand consistently consistently to to the the subcutaneous target site, adapting dynamically to tissue resistance. subcutaneous target site, adapting dynamically to tissue resistance. 2025200064
Thedisclosed The disclosedembodiments embodimentsmay may provide provide anytheoffollowing any of the following advantages: advantages:
1. 1. Precision Precision and and Accuracy Accuracy • Controlled Delivery: Real-time Controlled Delivery: Real-timesensor sensoradjustments adjustmentsensureensureprecise precise administration of administration of large large medication volumes. medication volumes. • Minimized MinimizedWaste: Waste: Efficientfluid Efficient fluiddynamics dynamicsreduce reduce residualliquid, residual liquid, maximizing maximizing drug utilization. drug utilization.
2. Enhanced 2. Safety Enhanced Safety • Automatic AutomaticNeedle Needle Retraction:Prevents Retraction: Prevents accidentalinjuries accidental injuriesand andenhances enhances devicesafety. device safety. • Pressure Pressure Regulation: Regulation: Closed-loop Closed-loopcontrol controlprevents preventsover-pressurization over-pressurizationand and improperflow. improper flow. 3. 3. User User Convenience Convenience • Adjustable Adjustable Volume Volume Range: Range: Supports Supports dosesdoses fromfrom 5 mL 5tomL 75to mL,75catering mL, catering to to diverse diverse medical needs. medical needs. • Portable Portable and and Compact: Compact:Designed Designedforfor ease ease of of useininvarious use variousenvironments, environments, including homeand including home andmobile mobile caresettings. care settings. 4. Hygiene 4. andCustomization Hygiene and Customization • Sterile Sterile Components: Disposablemodules Components: Disposable modules ensure ensure hygiene hygiene and and prevent prevent cross- cross- contamination. contamination. • Adaptive AdaptiveDelivery: Delivery:Accommodates Accommodates individual individual injection-site injection-site resistance resistance for for personalized treatment. personalized treatment.
Thedisclosed The disclosedembodiments embodimentsmay may be used be used for following for the the following applications: applications:
1. 1. Medical Devices Medical Devices • Ideal Ideal for for administering administering large-volume medications,such large-volume medications, suchasasmonoclonal monoclonal antibodies for autoimmune diseases, cancer, and inflammation. antibodies for autoimmune diseases, cancer, and inflammation.
2. Portable 2. Portable Healthcare Systems Healthcare Systems • Facilitates Facilitates at-home at-home or or mobile medicationadministration, mobile medication administration, promoting promotingpatient patient independence independence and andaccessibility. accessibility. • Suitable Suitable for for emergency medicalkits emergency medical kitsand andambulatory ambulatory infusion infusion pumps. pumps.
TheOn-Body The On-Body Injection Injection Device, Device, as as disclosed disclosed herein,provides herein, providesananimproved improved apparatus apparatus and and methodfor method forsubcutaneous subcutaneousmedication medication delivery, delivery, incorporating incorporating precisefluid precise fluidmanagement management and real-time and real-time monitoring functionalities. Some monitoring functionalities. embodiments Some embodiments of of thethe invention invention effectively effectively address the technical address the technical challenges challenges associated associated with with administering administering large-volume large-volume andandhigh- high- viscosity medications, viscosity medications, offering offering a practical a practical and efficient and efficient solution solution specifically specifically designeddesigned for for portable and disposable medical applications. The compact and modular design portable and disposable medical applications. The compact and modular design
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described enhances accessibility, usability, and operational efficiency, thereby meeting described enhances accessibility, usability, and operational efficiency, thereby meeting
diverse medical diverse requirementsand medical requirements andsupporting supportingimproved improved patient patient outcomes. outcomes.
The present disclosure relates to a high-efficiency fluid delivery system specifically The present disclosure relates to a high-efficiency fluid delivery system specifically
engineeredfor engineered for precise precise and/or and/or accurate accurate medication administration. This medication administration. This innovative innovative systemintegrates system integrates aa combination of advanced combination of advancedpressure pressuremanagement management techniques, techniques, modulardesign, modular design,and andreal-time real-timesensor sensorfeedback feedbacktotoensure ensureconsistent consistentand andreliable reliable 2025200064
medicament delivery. It is particularly suited for disposable and portable medical medicament delivery. It is particularly suited for disposable and portable medical
applications, offering a compact, user-friendly, and efficient solution for healthcare applications, offering a compact, user-friendly, and efficient solution for healthcare
providersandand providers patients patients alike. alike.
To ensure To ensureclarity clarity and and consistency throughoutthis consistency throughout this document, document,the thefollowing followingterms termsare are defined: defined:
1. Elastomer Diaphragm 1. Elastomer Diaphragm A flexible, A flexible, stretchable stretchablemembrane composed membrane composed of of durable, durable, biocompatible biocompatible materials.ItIt adapts materials. adaptsdynamically dynamically to pressure to pressure changeschanges and precise, and enables enables precise, consistent fluid displacement within the system, minimizingresidual consistent fluid displacement within the system, minimizing residual waste. waste. 2. Pressure-Building 2. Pressure-Building Chamber Chamber A sealed A sealed compartment compartment integratedwith integrated withthe theelastomer elastomerdiaphragm diaphragm to generate to generate andand maintain uniform maintain uniformpressure. pressure.ThisThischamber chamber ensures ensures smooth smooth and and consistent consistent deliveryofofmedication, delivery medication, particularly particularly for high-viscosity for high-viscosity fluids.fluids.
3. Dead 3. DeadSpace Space Theportion The portion of of aa medical medicaldevice devicewhere whereresidual residualliquid liquidremains remainsafter afteroperation, operation, leading to leading to medication wastage.Some medication wastage. Some embodiments embodiments of the of the invention invention minimize minimize dead space dead space through throughoptimized optimizedelastomer elastomer diaphragm diaphragm design. design. 4. Modular 4. ModularDesign Design A system A systemarchitecture architecture allowing allowingindependent independentreplacement, replacement, customization, customization, or or upgrading of components, such as reservoirs, diaphragms, or needle assemblies. upgrading of components, such as reservoirs, diaphragms, or needle assemblies. This promotes This promotesadaptability, adaptability, cost cost efficiency, efficiency,and and ease ease of ofmaintenance. maintenance. 5. Large-Volume Medication 5. Large-Volume Medication Delivery Delivery Theadministration The administrationof of medication medicationvolumesvolumes exceeding exceeding conventional conventional syringe syringe capacities,typically capacities, typicallyininthe therange rangeof of 5–75 5-75 mL. process mL. This This process often requires often requires slow slow infusion rates to ensure patient comfort and effective absorption. infusion rates to ensure patient comfort and effective absorption.
6. Smart 6. SmartTechnologies Technologies Integration Integration Advancedconnectivity Advanced connectivityfeatures, features,suchsuchasasBluetooth Bluetoothororwireless wirelesscommunication, communication, enabling real-time enabling real-time monitoring, remotedosage monitoring, remote dosagetracking, tracking,and anduser userfeedback feedback through integrated through integrated systems systemsor or external external devices. devices. 7. Adjustable 7. AdjustableNeedle Needle Sizes Sizes A customizable A customizablefeature featureaccommodating accommodating varying varying needle needle lengths lengths (e.g., (e.g., 4 mm, 4 mm, 6 6 mm,8 8mm)mm) mm, to suit to suit diverse diverse patient patient profiles, profiles, including including differences differences in skin in skin
thicknessororinjection thickness injection sitepreferences. site preferences. 8. Closed-Loop Control 8. Closed-Loop Control System System Anautomated An automated feedback feedback mechanism mechanism that monitors that monitors operational operational parameters, parameters, such such as flow rate, pressure, and tissue resistance, and dynamically adjusts in as flow rate, pressure, and tissue resistance, and dynamically adjusts settings settings in real-timetotooptimize real-time optimize safety safety and and precision. precision.
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Components andFeatures Components and Features
1. 1. Power DriveMechanism: Power Drive Mechanism: Thesystem The systemfeatures featuresa apower power drive drive mechanism mechanism that includes that includes a diaphragm a diaphragm air pumpair pump designed to designed to generate generate controlled controlled airflow. airflow. This This pump ensuresthat pump ensures that pressure pressure levels levels remain remain consistent and consistent and precise, precise, enabling accurate displacement enabling accurate displacementofofair air throughout throughoutthethedevice. device. 2025200064
2. Diaphragm 2. AirPump Diaphragm Air Pump Pressure Pressure Release: Release: Theembodiment The embodiment configured configured for for pressure pressure release release may may employ employ a diaphragm a diaphragm air air pump pump designed with designed withaa withdrawal withdrawalpressure pressurefunctionality functionalitytotoenable enableefficient efficientand andreliable reliable pressure regulation. pressure regulation. Alternatively, Alternatively, the the system mayincorporate system may incorporateelectric electricorormanual manual valve mechanisms valve mechanisms to to achieve achieve precise precise control control over over thepressure the pressurerelease releaseprocess. process. This This versatile arrangement versatile ensuresadaptability arrangement ensures adaptabilityandandoptimized optimized performance performance across across a broad a broad range of range of applications applications that thatdemand controlled and demand controlled and accurate accurate pressure pressure management. management.
3. Torus 3. Torus Reservoir Housing: Reservoir Housing: The central housing of the system is a torus-shaped reservoir, optimized for efficient The central housing of the system is a torus-shaped reservoir, optimized for efficient
medicamentcontainment medicament containment andand delivery. delivery. This This housing housing includes: includes:
• Pressure Chamber: Pressure Chamber:Maintains Maintains uniform uniform pressure pressure to to regulatethethedeformation regulate deformationof of the elastomer the elastomer diaphragm. Thischamber diaphragm. This chamber minimizes minimizes thethe likelihood likelihood of of weak weak points points or inconsistencies or inconsistencies in inthe thediaphragm’s diaphragm's movement, ensuringintegrity movement, ensuring integrity and andreliable reliable operation. operation.
• Air Air Diffuser Diffuser Diaphragm: Designed Diaphragm: Designed to to distributeairflow distribute airflowevenly evenlyacross acrossthe the elastomer surface, elastomer surface, minimizing minimizing stressstress concentrations. concentrations. This balanced This balanced distribution distribution
reducesthe reduces therisk riskofofmaterial material fatigue fatigue and and significantly significantly lowerslowers the likelihood the likelihood of of failure. failure.
• Elastomer ElastomerDiaphragm: Diaphragm: A key A key innovation innovation of the of the system, system, thethe elastomer elastomer diaphragmadapts diaphragm adaptsdynamically dynamically to to variationsininapplied variations appliedpressure, pressure, providing providing consistent and efficient fluid displacement. This diaphragm is robust yet consistent and efficient fluid displacement. This diaphragm is robust yet
flexible, ensuringdurability. flexible, ensuring durability.
Functional Capabilities Functional Capabilities
UniformPressure Uniform PressureApplication: Application: Theintegrated The integrated pressure pressure chamber chamberapplies appliesconsistent consistentpressure pressureacross across the the elastomer elastomer diaphragm’s surface. This design prevents localized stress and ensures that the diaphragm's surface. This design prevents localized stress and ensures that the
diaphragmdeforms diaphragm deformsin in a acontrolled controlledand anduniform uniform manner, manner, facilitatingsmooth facilitating smooth medicament medicament deliveryeven delivery even under under operational operational conditions. conditions.
OptimizedAirflow Optimized AirflowDistribution: Distribution: The air diffuser diaphragm plays a critical role in distributing airflow evenly within the The air diffuser diaphragm plays a critical role in distributing airflow evenly within the
pressure chamber. pressure chamber.This Thisfeature feature preconditions preconditionsthe the elastomer elastomerdiaphragm diaphragm formechanical for mechanical stretching stretching or or fluid fluiddisplacement, displacement,improving improving performance andminimizing performance and minimizing risks risks associatedwith associated with uneven uneven stretching stretching or tearing. or tearing.
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DynamicPressure Dynamic Pressure Adaptation: Adaptation: Theelastomer The elastomerdiaphragm's diaphragm’s materialcomposition material composition allows allows it it toto adaptdynamically adapt dynamically to to pressure variations, ensuring high-efficiency fluid delivery. This adaptability is pressure variations, ensuring high-efficiency fluid delivery. This adaptability is
particularly beneficial particularly beneficialfor foradministering administeringhigh-viscosity high-viscositymedicaments or precise medicaments or precise doses doses required in acute medical scenarios. required in acute medical scenarios.
Some disclosedembodiments Some disclosed embodiments may may provide provide a transformative a transformative advancement advancement in fluid in fluid 2025200064
deliverysystems, delivery systems, combining combining unparalleled unparalleled precision, precision, safety, safety, versatility, versatility, and reliability. and reliability.
Its modular Its design enables modular design enables both both disposable disposableand andportable portableconfigurations, configurations, addressing addressingthethe evolving needsof evolving needs of modern modernhealthcare healthcareandandpatient-centric patient-centricsolutions. solutions. Below Belowarearedetailed detailed applicationsand applications and potential potential benefits benefits of this of this high-efficiency high-efficiency system:system:
Applications Applications
1. Self-AdministrationofofMedication 1. Self-Administration Medication o Empowering Patients:TheThe Empowering Patients: system system allows allows individuals individuals withwith chronic chronic conditions to conditions to administer administer medications accurately at medications accurately at home, reducing home, reducing dependence dependence on clinical on clinical visits. visits.
EnhancedCompliance: o Enhanced Compliance: Features Features suchsuch as real-time as real-time monitoring monitoring and and user-friendly controls user-friendly controls improve medicationadherence. improve medication adherence. Flexible Dosing: o Flexible Supportsadjustable Dosing: Supports adjustabledoses, doses, accommodating accommodating a wide a wide range of range of treatment treatment regimens, including weekly regimens, including weeklybiologics biologicsand anddaily daily hormonetherapies. hormone therapies. 2. Ambulatory 2. AmbulatoryInfusion Infusion Pumps Pumps o Seamless Delivery:Enables Seamless Delivery: Enablescontinuous continuous or or intermittentmedication intermittent medication delivery for delivery for patients patientson onthe themove, move, ideal idealforforchemotherapy, chemotherapy, pain pain management, management, andand hydration hydration therapy. therapy. Portability:Compact o Portability: Compact and and lightweight, lightweight, the system the system is tailored is tailored for mobile for mobile
use, enhancing use, patient independence enhancing patient independence and andreducing reducing hospitalvisits. hospital visits. o Extended Duration: Capable of managing large-volume infusions Extended Duration: Capable of managing large-volume infusions (5-75(5–75 mL)over mL) over hours, hours, ensuring ensuring consistent consistent therapeutic therapeutic effects.effects.
3. Emergency 3. EmergencyMedical MedicalKits Kits Critical Scenarios: o Critical Scenarios:Provides Provides rapid, rapid, reliable reliable drug drug delivery delivery for trauma for trauma
care, allergic reactions (epinephrine), or cardiac emergencies (adenosine care, allergic reactions (epinephrine), or cardiac emergencies (adenosine
or atropine). or atropine). Remoteand o Remote andDisaster DisasterRelief: Relief:Portable Portableandanddisposable disposableconfigurations configurations makeititsuitable make suitableforfordeployment deployment in remote in remote areas or areas or disaster-stricken disaster-stricken
regions. regions.
o Versatility: Versatility:Supports Supports aa wide wide range range of of medications, medications, from low-volume from low-volume emergency drugs to large-volume hydration solutions. emergency drugs to large-volume hydration solutions. 4. Biologic 4. BiologicandandHigh-Viscosity High-Viscosity Drugs Drugs o Complex Therapies: Complex Therapies: Ensures Ensures precise precise dosing dosing of of biologics biologics such such as as monoclonalantibodies monoclonal antibodies(e.g., (e.g., Adalimumab, Adalimumab, Infliximab) Infliximab) forfor autoimmune autoimmune disorders, cancer, and inflammation. disorders, cancer, and inflammation. HighViscosity o High ViscosityManagement: Management: The The elastomer elastomer diaphragm’s diaphragm's advanced advanced pressure regulation efficiently handles thick medications, reducing pressure regulation efficiently handles thick medications, reducing
delivery time delivery time without compromising without compromising accuracy. accuracy.
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Biosimilar Applications: o Biosimilar Applications: Optimized Optimizedfor foremerging emerging biosimilars, biosimilars, addressing global addressing global demand demandfor foraffordable, affordable,high-quality high-qualitytreatments. treatments. 5. SpecializedMedical 5. Specialized MedicalApplications Applications Vaccinesand o Vaccines andImmunotherapy: Immunotherapy: Delivers Delivers precise precise doses doses of high-value of high-value vaccines and checkpoint inhibitors for cancer treatment. vaccines and checkpoint inhibitors for cancer treatment.
Paediatric and o Paediatric and Geriatric Geriatric Care: Care: Customizable volumes Customizable volumes andand safety safety features make the system ideal for sensitive populations requiring features make the system ideal for sensitive populations requiring 2025200064
controlledand controlled andgentle gentle administration. administration.
Rare Diseases: o Rare Diseases: Supports Supportsprecise precisedelivery delivery ofof orphan orphandrugs drugsthat that often often requirespecific require specificdosing dosing andand careful careful handling. handling.
Potential Benefits Potential Benefits
1. Precision 1. Precision o Uniform Delivery:The Uniform Delivery: Theelastomer elastomer diaphragm’s diaphragm's uniform uniform deformation deformation ensures consistent medicament ensures consistent delivery,even medicament delivery, evenfor forlarge large or or viscous viscous volumes. volumes. o Sensor-Driven Accuracy: Sensor-Driven Accuracy: Integrated Integrated sensorssensors adjust adjust flow ratesflow rates in real- in real-
time, compensating for variations in tissue resistance and medication time, compensating for variations in tissue resistance and medication
viscosity. viscosity.
2. Safety 2. Safety Pressure Regulation: o Pressure Regulation: Advanced Advanced mechanisms mechanisms minimize minimize risks risks of over- of over- pressurization,air pressurization, airleaks, leaks,ororimproper improper dosing. dosing.
NeedleRetraction: o Needle Retraction: Automatic Automatic retraction retraction reducesreduces the risk the risk of accidental of accidental
injuries, enhancing user confidence. injuries, enhancing user confidence.
o Closed-Loop Control:Real-time Closed-Loop Control: Real-time feedback feedback ensures ensures safesafe operation operation by by preventing delivery errors. preventing delivery errors.
3. Versatility 3. Versatility BroadCompatibility: o Broad Compatibility:ModularModular design design accommodates accommodates a diverse a diverse rangerange of medicaments, of includinghigh-viscosity medicaments, including high-viscositydrugs, drugs,biologics, biologics, andand emergency medications. emergency medications. o Customizable Dosing: Customizable Dosing: Adjustable Adjustable volumes volumes (5–75 (5-75 mL) mL) catercater to various to various therapeutic requirements. therapeutic requirements. Multi-SettingUsability: o Multi-Setting Usability: Suitable Suitable for home for home care, clinical care, clinical use, anduse, and remote healthcare environments. remote healthcare environments. 4. Reliability 4. Reliability DurableComponents: o Durable Components: Built Built with with high-quality high-quality materials materials toto withstand withstand frequent frequent use use and demandingconditions. and demanding conditions. Long-Term o Long-Term Performance: Performance: Designed Designed for consistent for consistent operation, operation, eveneven in in high-pressure high-pressure applications applications or extended or extended infusion infusion scenarios. scenarios.
o Redundancy and Backup: Safety mechanisms ensure reliability, Redundancy and Backup: Safety mechanisms ensure reliability, eveneven in in critical or critical or unexpected conditions. unexpected conditions.
This high-efficiency This high-efficiency fluid fluid delivery delivery system system introduces introduces significant significantadvancements in advancements in medicationadministration medication administrationbybyintegrating integrating elastomer elastomerdiaphragm diaphragm technology, technology, advanced advanced pressure management, pressure management, and and real-time real-time monitoring. monitoring. Addressing Addressing the the criticallimitations critical limitationsofof
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traditional systems, it provides enhanced precision, safety, and adaptability for traditional systems, it provides enhanced precision, safety, and adaptability for
subcutaneousand subcutaneous andlarge-volume large-volume medicament medicament delivery. delivery.
Withversatile With versatile applications applications and and aa user-focused user-focused design, design, this thissystem system supports supports ongoing ongoing progress in personalized medicine, remote healthcare, and telehealth. It enables progress in personalized medicine, remote healthcare, and telehealth. It enables
healthcare providers and patients to access more efficient, reliable, and accessible drug healthcare providers and patients to access more efficient, reliable, and accessible drug
deliverysolutions delivery solutionstailored tailored to to thethe evolving evolving needsneeds of modern of modern medical practices. medical practices. 2025200064
Lookingahead, Looking ahead,this this innovation innovationcontributes contributes to to aa future future where healthcare systems where healthcare are systems are better equipped better to meet equipped to diverse therapeutic meet diverse therapeutic demands. Themodular demands. The modular architectureandand architecture smart integration smart integration capabilities capabilitiesensure ensurethe thesystem systemremains remains adaptable, adaptable, supporting supporting advancementsinindrug advancements drugdelivery deliverytechnologies technologiesand and improving improving patient patient outcomes outcomes
[0001] Auto-injectors
[0001] Auto-injectors are are medical medical devices devices that facilitate that facilitate delivery delivery of more of one or one doses or more doses of medicament of medicament byby subcutaneous subcutaneous injection.Auto-injectors injection. Auto-injectorsmay maybe be particularlyuseful particularly usefulfor for self-administration of an injection. In some cases, auto-injectors may be used for the self-administration of an injection. In some cases, auto-injectors may be used for the
management management of of chronic chronic diseases. diseases.
[0002] On-bodyinjectors
[0002] On-body injectors(OBIs) (OBIs)arearea atype typeofofauto-injector auto-injectorspecifically specifically designed designedtoto be be attached to the user's body. These devices enable the controlled and sustained delivery of attached to the user's body. These devices enable the controlled and sustained delivery of
a medicament a overananextended medicament over extended period. period.
[0002A] Thereis isprovided
[0002A] There provided a fluid a fluid delivery delivery system system for for injecting injecting a medicament a medicament into into a a patient, the patient, the system comprising:a areservoir system comprising: reservoirassembly assembly having: having: an internal an internal volume volume for for holding the holding the medicament; medicament; and andananelastomer elastomerdiaphragm; diaphragm; a diaphragm a diaphragm air air pump pump configured configured to generate to generate aa controlled controlled airflow airflowand anddirect directthethecontrolled controlledairflow airflowontoontothethe elastomer elastomer diaphragm;and diaphragm; andaacontroller controller configured configured to to actuate actuate the thediaphragm diaphragm airair pump pump toto controllably controllably cause the cause the elastomer elastomer diaphragm diaphragm to toretract retract to todraw draw the themedicament medicament intointo the the internal internalvolume volume of the reservoir assembly, or to stretch to expel the medicament from the internal volume of the reservoir assembly, or to stretch to expel the medicament from the internal volume
of the of the reservoir reservoirassembly assembly and and into into the patient. the patient.
[0002B] Thereisisalso
[0002B] There also provided provideda amedicament medicament injection injection device device comprising comprising a disposable a disposable modulewith: module with:aareservoir reservoir defining defining an an internal internal volume to hold volume to holdaa medicament, medicament, and and having having an elastomer an diaphragm;a aport elastomer diaphragm; portconnection connectionfor forfluid fluid coupling with aa medicament coupling with medicament source; source; a needle a assembly,including needle assembly, includinga aneedle needlemovable movable between: between: a retracted a retracted position position in which in which the needle the is housed needle is withinthe housed within the module; module;andand an an extended extended position position in which in which the the needle needle protrudes from the module; an adhesive layer for releasable attachment to a user; a needle protrudes from the module; an adhesive layer for releasable attachment to a user; a needle
actuation mechanism actuation operable mechanism operable to to move move the the needle needle between between the retracted the retracted and extended and extended positions;and positions; anda acontroller controllerconfigured configured to operate to operate an electrically an electrically powered powered drive mechanism drive mechanism
to controllably to controllably cause cause the theelastomer elastomer diaphragm diaphragm to to retract retract totodraw draw the themedicament into the medicament into the internal volume internal volume of of thethe reservoir reservoir assembly, assembly, or to or to stretch stretch to expel to expel the medicament the medicament from the from the
internal internal volume volume ofof the the reservoir reservoir assembly and through assembly and throughthethe needle. needle.
[0003] Any
[0003] Any discussion discussion of documents, of documents, acts, materials, acts, materials, devices, devices, articles, articles, or the like or the like
included in the present specification is not to be taken as an admission that included in the present specification is not to be taken as an admission that any anyofor all of or all
these matters these matters were common were common general general knowledge knowledge in the in the field field relevant relevant to to thepresent the present disclosure as it existed before the priority date of each of the appended claims. disclosure as it existed before the priority date of each of the appended claims.
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[0004] In one
[0004] In embodiment, one embodiment, thediaphragm the diaphragm airair pump pump generates generates a controlled a controlled airflow, airflow, which is directed onto the elastomer, causing it to stretch into the torus reservoir. The which is directed onto the elastomer, causing it to stretch into the torus reservoir. The
vacuumchamber vacuum chamber creates creates a low-pressure a low-pressure zone, zone, aiding aiding in in energy energy storage storage andand release release cycles. The air diffuser distributes incoming air evenly, minimizing turbulence and cycles. The air diffuser distributes incoming air evenly, minimizing turbulence and
maximizingoperational maximizing operationalefficiency. efficiency.TheTheelastomer elastomerdiaphragm diaphragmdrawsdraws medication medication from from the external vial into the reservoir and expels it from the reservoir into the needle tip. the external vial into the reservoir and expels it from the reservoir into the needle tip. 2025200064
[0005] Accordingtotoone
[0005] According oneaspect aspectofofthe the present present disclosure, disclosure, aa medicament injection medicament injection device is device is provided. provided. It Itincludes includesa areservoir holding reservoir holdinga liquid medicament a liquid medicamentandanda adiaphragm diaphragm pumpthat pump thatapplies applies either either pressure pressure oror vacuum vacuum to to an an elastomer elastomerdiaphragm. diaphragm.WhenWhen pressurized,the pressurized, thediaphragm diaphragm stretches stretches insideinside the reservoir the reservoir to expeltothe expel the medicament; medicament; in in vacuummode, vacuum mode, it itretracts retracts to to draw the medicament draw the medicament intothe into thereservoir. reservoir.
[0006]
[0006] AAport port is is configured for connection configured for to aa medicament connection to source,fluidly medicament source, fluidly coupled coupled with the internal volume of the reservoir. with the internal volume of the reservoir.
[0007]
[0007] A A needle needle assembly assembly includes includes a needle a needle with atip, with a defined defined tip, the the needle needle being being in fluid in fluid
communication communication with with thethe internalvolume internal volumeandand movable movable between between a retracted a retracted position position and and an extended position. an extended position.
[0008] Anadhesive
[0008] An adhesivelayer layerisis arranged arranged to to enable enable the the releasable releasable mounting of the mounting of the disposable module disposable moduletotoaauser. user.
[0009]
[0009] AAneedle needleactuation actuation mechanism mechanismis is arranged arranged to to couple couple with with theneedle the needle assembly, assembly, the needle the needle actuation actuation mechanism operabletotomove mechanism operable movethethe needle needle between between the the retracted retracted position and the extended position. position and the extended position.
[0010] Aninternal
[0010] An internal micro microdiaphragm diaphragm airpump air pump uses uses thethe back-and-forth back-and-forth motion motion of aof a flexible membrane flexible membrane to generate to generate airflow, airflow, allowing allowing it to either it to either increase increase pressure pressure or create or create
a vacuum as needed. a vacuum as needed.
[0011]
[0011] AAdiaphragm diaphragm pump pump is described, is described, comprising comprising a pressure a pressure chamber, chamber, an airflow an airflow diaphragm,and diaphragm, andananelastomer elastomerdiaphragm. diaphragm. TheThe pump pump outlet outlet provides provides a pressurizing a pressurizing force force that moves that moves thethe elastomer elastomer diaphragm diaphragm along along the the reservoir’s reservoir's internal internal torus walltorus to itswall far to its far
end, positioning end, positioning it itfor forwithdrawing withdrawing the vial’s the vial's medicament medicament into the into the reservoir. reservoir.
[0012] Thediaphragm
[0012] The diaphragmairairpump pumphashas a pump a pump inlet. inlet. TheThe pump pump inlet inlet controls controls thethe vacuum, vacuum, allowing the allowing the elastomer elastomer to to draw medicament draw medicament from from thethe medicament medicament source source into into the the internal reservoir.The internal reservoir. The drive drive mechanism mechanism is further is further operable operable to apply to apply a force a pressing pressing force through the through the pump pumpoutlet, outlet, causing causing the the elastomer elastomer toto move movethrough throughthe theinternal internal volume volumeofof the reservoir and expel the medicament through the needle tip. the reservoir and expel the medicament through the needle tip.
[0013] Twocontrollers
[0013] Two controllersare areprovided: provided:oneoneconfigured configuredtoto manage manage the the operation operation of the of the needle stepper needle stepper motor, motor,and andthe theother othertoto regulate regulate the the diaphragm diaphragmair airpump, pump, controlling controlling both vacuum both vacuumandand pressure pressure appliedtotothe applied theelastomer elastomerdiaphragm. diaphragm.
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[0014] In one
[0014] In embodiment, one embodiment, themedicament the medicament injection injection device device maymay include include one one or more or more sensors associated sensors associated with with the the drive drivemechanism. Theone mechanism. The oneorormore moresensors sensorsmay may be be operable operable to measure a force indicative of tissue resistance. The controller may be to measure a force indicative of tissue resistance. The controller may be
communicatively communicatively coupled coupled with with thethe oneone or or more more sensors. sensors. TheThe controller controller maymay be be configured such that, responsive to receiving sensed data from the one or more sensors, configured such that, responsive to receiving sensed data from the one or more sensors,
the controller the controllerdetermines determines anan optimum flowrate. optimum flow rate. The The controller controller may adjust the may adjust the operation operation of the drive mechanism to expel the medicament at the optimum flow rate. The one of the drive mechanism to expel the medicament at the optimum flow rate. The one or or 2025200064
moresensors more sensorsmay mayinclude includea aforce forcesensor sensoroperable operabletotomeasure measure a a resistanceforce resistance force opposed opposed to to thethe driving driving force. force.
[0015] Theneedle
[0015] The needleactuation actuationmechanism mechanism maymay include include a stepper a stepper motor motor operatively operatively coupledto coupled to aa cam member. cam member. The The member member may may be be arranged arranged to contact to contact the needle the needle assembly.The assembly. Thestepper steppermotor motorisisoperable operabletotomove movethethemember member to exert to exert a force a force onon thethe needle assembly needle assemblytotomovemovethetheneedle needletoward toward thethe extended extended position. position. TheThe needle needle maymay be be resiliently biased resiliently towards biased towards thethe retracted retracted position. position. The stepper The stepper motor motor may may betooperable to be operable
movethe move themember member to to reduce reduce thethe force force onon theneedle the needle such such thatthe that theneedle needlemoves moves toward toward the retracted the retractedposition. position.
[0016] In another
[0016] In embodiment,thethecontroller another embodiment, controllermay maybebeassociated associatedwith withatatleast least one one activation mechanism activation foractivating mechanism for activating the the drive drive mechanism mechanism toto move move thethe elastomer elastomer diaphragmtotodraw diaphragm drawmedication medication intothetheinternal into internalvolume volumeand/or and/orforforactivating activatingthe the diaphragmpump diaphragm pump moving moving forward forward the elastomer the elastomer inside inside the reservoir the reservoir to expel to expel thethe medicament. medicament.
[0017] According
[0017] According to another to another aspectaspect of the of the present present disclosure, disclosure, there is there is provided provided a a medicamentinjection medicament injectiondevice deviceincluding includinga areservoir reservoirdefining definingan aninternal internal volume volume forfor containing aa liquid containing liquid medicament, medicament, aa drive drive mechanism housed mechanism housed within within thethe reservoir,and reservoir, andanan elastomer diaphragm elastomer diaphragmextending extending along along thethe internalvolume, internal volume, designed designed to to expel expel the the medicament medicament when when actuated actuated by by thethe drive drive mechanism mechanism and draw and draw up medicament up medicament as as mentionedabove. mentioned above.A Aneedle needle assembly assembly includes includes a needle a needle withwith a tipininfluid a tip fluid communication communication with with thethe internalvolume internal volume andand movable movable between between a retracted a retracted position position wherethe where the tip tip is ishoused housed within within thethe disposable disposable module andananextended module and extendedposition positionwhere where the tip the tipprotrudes protrudes from from thethe module. module. An adhesivelayer An adhesive layerenables enablesreleasable releasable mounting mountingofof the disposable the disposable module module ontoontothetheuser. user. AAdrive drive mechanism mechanism is is configured configured to to actuatethe actuate the elastomerdiaphragm, elastomer diaphragm, causing causing it to it to stretch stretch withinwithin the internal the internal volume volume toward thetoward end, the end, thereby drawing thereby drawingmedication medicationinto intothethereservoir. reservoir. Sensors Sensors associated associated withwith the the drive drive mechanism mechanism measure measure forces forces indicative indicative of of tissueresistance. tissue resistance. AAcontroller controller processes processes data data from the sensors to determine the optimum flow rate and adjusts the operation of the from the sensors to determine the optimum flow rate and adjusts the operation of the drive mechanism drive mechanism totoexpel expelthe themedicament medicament at at thethe determined determined rate. rate.
[0018] The
[0018] The term term "comprises" "comprises" is used isthroughout used throughout this specification this specification to signifyto signify inclusion. inclusion. It It is is not not exclusive and exclusive and does does not not limit limit the the addition addition of other of other elements, elements, steps, steps, or or features features
beyond beyond those those explicitly explicitly stated. stated. For For example, example, if a device if a device "comprises" "comprises" a reservoir a reservoir and a and a diaphragmpump, diaphragm pump, additional additional featureslike features likesensors sensorsoror adhesive adhesivelayers layers may maystill still be be included included without deviating without deviating from fromthethe described describedembodiments embodiments of of thethe invention.This invention. This interpretation interpretation ensuresflexibility ensures flexibilityininthe thescope scope of of thethe disclosure disclosure and supports and supports adaptations adaptations for different for different
implementations. implementations.
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[0019] This specification
[0019] This specification encompasses encompasses bothbothindividual individualand andcombined combined features, features, components,ororsteps. components, steps. For For instance: instance: • AA single single feature, feature, such such as as aa diaphragm pump,may diaphragm pump, may function function independently. independently. • AA combined combined embodiment embodiment mightmight integrate integrate multiple multiple components, components, such such as sensors, as sensors, controllers, and controllers, and needle needle mechanisms. mechanisms. Thespecification The specification explicitly explicitly includes includes all combinations all combinations of two of two steps or more or more or steps or 2025200064
features, ensuringadaptability features, ensuring adaptabilityto atowide a wide rangerange of applications of applications and useand use cases. cases.
[0020]
[0020] ItIt will will be be appreciated appreciated that thatauto-injectors auto-injectors areare medical medicaldevices devicesthat that administer administer one one oror more dosesofofmedicament more doses medicament viavia subcutaneous subcutaneous injection. injection. TheThe design design of of auto- auto- injectors simplifies the injection process, reduces human error, and enhances user safety. injectors simplifies the injection process, reduces human error, and enhances user safety.
Theyareareparticularly They particularly valuable valuable for: for:
1. Self-administration: Empowering 1. Self-administration: Empowering patients patients to to independently independently manage manage chronic chronic conditions,such conditions, suchas as diabetes diabetes or arthritis. or arthritis.
2. Untrained 2. Untrainedusers: users:Offering Offeringsimplicity simplicityforfor emergency emergencysituations situationslike like anaphylaxis anaphylaxis treatment. treatment.
[0021]
[0021] AAtypical typical auto-injector auto-injector comprises the following comprises the followingcomponents: components: Syringe/Container:Houses • Syringe/Container: Housesthethemedicament medicament securely. securely. Needle: Punctures • Needle: Puncturesthe theskin skintoto deliver deliver the the medicament medicament totothethetissue. tissue. Plunger and • Plunger andStopper: Stopper:Pushes Pushesthe themedicament medicament outout of of thethe syringe syringe through through thethe needle. needle.
[0021A] Additionally,auto-injectors
[0021A] Additionally, auto-injectors may may incorporate incorporate automation automation to: to: • Insert the needle Insert the needleinto intothethe skin skin at at a consistent a consistent depth. depth.
Advancethe • Advance thestopper stoppertotoensure ensureaccurate accuratedosing. dosing.
[0021B] On-body
[0021B] On-body injectors(OBIs) injectors (OBIs) arespecialized are specializedauto-injectors auto-injectorsdesigned designedfor for temporaryattachment temporary attachmenttotothe thebody, body,delivering deliveringmedicament medicament over over extended extended periods. periods.
[0022] Referencestoto other
[0022] References other documents, documents,devices, devices,orortechnologies technologiesininthis this specification specification do do not imply that these are part of the general knowledge in the field prior to the priority not imply that these are part of the general knowledge in the field prior to the priority
date. date.
[0023] Onedisclosed
[0023] One disclosedembodiment embodiment includes includes a diaphragm a diaphragm air pump air pump that achieves that achieves any of: any of: • Generates controlled airflow Generates controlled airflow toto stretch stretch an an elastomer diaphragm. elastomer diaphragm. Uses aa vacuum • Uses vacuumchamber chamber to create to create low-pressure low-pressure zones, zones, enhancing enhancing the the diaphragm’s movement. diaphragm's movement. Drawsmedicament • Draws medicament fromfrom an external an external vial vial intothe into thereservoir reservoirand andexpels expelsitit through through the needle. the needle. This system This systemensures ensuresefficient efficient medicament transferwith medicament transfer withminimal minimal turbulence, turbulence, aided by an air diffuser. aided by an air diffuser.
[0024] Thedisclosed
[0024] The disclosedmedicament medicament injection injection device device maymay include: include: 1. Reservoir:Stores 1. Reservoir: Storesliquid liquid medicament. medicament. 2. Diaphragm 2. DiaphragmPump: Pump:Operates Operatesinin two two modes: modes:
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o Pressure Mode: Pressure Mode:Stretches Stretchesthe thediaphragm diaphragmto to expel expel medicament. medicament. o Vacuum Vacuum Mode: Mode: Retracts Retracts the the diaphragm diaphragm to draw to draw medicament medicament into into the the reservoir. reservoir.
This dual This dual functionality functionality supports supports efficient efficientand andprecise precisemedicament medicament handling. handling.
[0025]
[0025] TheThe disclosed disclosed device device may mayinclude includea aport portforforfluid fluidconnection connectiontotoexternal external 2025200064
medicament medicament sources, sources, such such as vials as vials or cartridges. or cartridges. Thisisport This port is seamlessly seamlessly integrated integrated with the with the
reservoir, enabling reservoir, enablingsterile sterileandand efficient efficient medicament medicament transfer. transfer.
[0026] Theneedle
[0026] The needleassembly assembly may may include: include: • AA needle needletip tip in in fluid fluid communication communication withwiththe thereservoir. reservoir. The ability • The ability to to move between: move between: Retracted Position: o Retracted Position: Safely housedwithin Safely housed withinthe themodule. module. o Extended Position: Protrudes for injection. Extended Position: Protrudes for injection.
This mechanism This mechanism ensures ensures safety safety andand sterilitybefore sterility beforeand andafter afteruse. use.
[0027] Anadhesive
[0027] An adhesivelayer layermay maybebeprovided provided to to securelyattach securely attachthe thedisposable disposablemodule moduletotothe the user’s skin. It provides: user's skin. It provides:
• Stability Stability during during medicament delivery,and/or medicament delivery, and/or Easy removal • Easy removalpost-use, post-use,leaving leavingnonoresidue. residue.
[0028] Thedisclosed
[0028] The disclosedembodiments embodiments maymay include include a pump a pump to generate to generate airflow airflow through through the the motionofofaa flexible motion flexible membrane, membrane, whichwhichmaymay be internal be an an internal micro micro diaphragm diaphragm pump,pump, enabling: enabling:
Increased pressure • Increased pressure for for medicament medicament expulsion,and/or expulsion, and/or Vacuum • Vacuum generation generation forfor medicament medicament withdrawal. withdrawal. Its Its compact design compact design allows allows efficient efficient integration integration into into the the overall overall system. system.
[0029] Thedisclosed
[0029] The discloseddiaphragm diaphragm pump pump may may include: include: Pressure Chamber: • Pressure Chamber:Manages Manages airflow airflow dynamics. dynamics. ElastomerDiaphragm: • Elastomer Diaphragm: Moves Moves along along the the reservoir reservoir wallwall to to control control medicament medicament flow. flow.
PumpOutlet: • Pump Outlet:Provides Providesthe thenecessary necessaryforce forcetotoexpel expelmedicament medicament or or refillthe refill the reservoir. reservoir.
[0030] Thedisclosed
[0030] The disclosedpump pump inlet inlet controls controls vacuum vacuum pressure, pressure, allowing allowing the the elastomer elastomer diaphragmto: diaphragm to: 1. Drawmedicament 1. Draw medicamentintointo the the reservoir. reservoir. 2. Expel 2. Expelmedicament medicament through through the the needle needle at controlled at controlled rates. rates.
[0031] Thedisclosed
[0031] The disclosedembodiments embodiments maymay include include two two controllers controllers to manage to manage the system, the system, configured as: configured as:
1. NeedleStepper 1. Needle StepperMotor Motor Controller: Controller: Operates Operates needle needle movements, movements, and and 2. Diaphragm 2. Diaphragm Pump Pump Controller: Controller: Regulates Regulates airflow airflow and pressure and pressure to optimize to optimize diaphragmfunctionality. diaphragm functionality.
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[0032] Thedisclosed
[0032] The disclosedembodiments embodiments maymay include include sensors sensors to measure to measure tissue tissue resistance resistance during injection,providing during injection, providing real-time real-time feedback feedback to the to the controller. controller. Sensed Sensed data datatois used to is used
adjust the adjust the medicament flowrate, medicament flow rate, ensuring ensuringprecise precise and and comfortable comfortabledelivery. delivery.
[0033] Thedisclosed
[0033] The disclosedneedle needleactuation actuationmechanism mechanism maymay employ employ a stepper a stepper motormotor and cam and cam membertotomove member movethethe needle needle between between its its retractedand retracted and extended extended positions.A A positions. resilientbias resilient bias mayensure may ensurethe theneedle needleremains remainssafely safelyretracted retracted when whennotnotininuse. use. 2025200064
[0034] Thedisclosed
[0034] The disclosed controllermay controller may coordinate coordinate critical critical functions, functions, such such as:as: Activating the • Activating the diaphragm diaphragmtotodraw drawmedicament medicament intointo the the reservoir. reservoir. • Driving the diaphragm Driving the diaphragmtotoexpel expelmedicament medicament during during injection. injection. Thisprocess This processcancan be be user-initiated user-initiated or automated. or automated.
[0035] Thesystem
[0035] The systemmaymay include: include: • AA reservoir reservoir and and diaphragm diaphragmforformedicament medicament storage storage and and delivery. delivery. • A retractable needle assembly. A retractable needle assembly. • Sensors and Sensors and controllers controllers for for precision precision operation. operation.
Anadhesive • An adhesivelayer layerfor for secure secure placement. placement.
[0036] Thedisclosed
[0036] The discloseddisposable disposablemodule module may may be be configured configured to facilitatesingle-use to facilitate single-use applications while applications while maintaining sterility and maintaining sterility andefficiency. efficiency.The Themodule module may includethe may include the following elements: following elements:
1. Reservoirwith 1. Reservoir withInternal Internal Volume Volume o AA reservoir reservoir isis provided provided to to store store liquid liquidmedicament. medicament. Theinternal o The internalvolume volume is specifically is specifically designed designed to maintain to maintain sterility, sterility,
prevent leaks, and accommodate various medicament viscosities. prevent leaks, and accommodate various medicament viscosities. Thereservoir o The reservoir isis sealed sealed totoprevent preventcontamination contamination during during handling handling andand use. use. 2. Elastomer 2. Elastomer Diaphragm Diaphragm This stretchable o This stretchable diaphragm diaphragm isis housed housedwithin withinthe thereservoir. reservoir. o ItIt moves along the moves along the internal internal volume volume toto expel expel the the medicament during medicament during operation operation andand retracts retracts totodraw draw medicament medicament into intothe the reservoir reservoir when when activated by activated by aa vacuum. vacuum. Thediaphragm o The diaphragmisismade made of of biocompatible biocompatible materials materials to to ensure ensure safety safety and and prevent reactions with the medicament. prevent reactions with the medicament. 3. Adhesive 3. Adhesive Layer Layer Themodule o The moduleincludes includesananadhesive adhesive layertotosecurely layer securelyattach attachthe the device device toto the user's the user’sskin. skin. Theadhesive o The adhesiveisis designed designedtoto bebe hypoallergenic, hypoallergenic, providing providingaa strong strong but but temporarybond temporary bondthatthatisis easy easy to to remove after use remove after use without without causing causing discomfortor or discomfort leaving leaving residue. residue.
Theadhesive o The adhesiveensures ensuresstable stable positioning positioning during during medicament medicament delivery, delivery, reducing the reducing the risk risk ofof dislodgment. dislodgment.
[0037] Thedisclosed
[0037] The disclosedneedle needleassembly assemblydelivers deliversthe themedicament medicament into into thethe patient’sbody. patient's body. Its design prioritizes safety, sterility, and/or efficiency. The assembly may include: Its design prioritizes safety, sterility, and/or efficiency. The assembly may include:
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1. Needle Design 1. Needle Design Theneedle o The needle is is fluidly fluidly connected connected to internal to the the internal reservoir, reservoir, ensuring ensuring
consistent medicament consistent medicament flow.flow. Theneedle o The needleis is made froma abiocompatible made from biocompatible material,such material, suchasasstainless stainless steel, to minimize patient discomfort and ensure durability. steel, to minimize patient discomfort and ensure durability.
2. Needle 2. NeedlePositions Positions o RetractedPosition: Retracted Position: 2025200064
Whennot ▪ When notininuse, use,the the needle needle is is housed within the housed within the disposable disposable module,ensuring module, ensuring safety safety and sterility. and sterility.
Thisposition ▪ This positionreduces reduces the the riskrisk of accidental of accidental needle needle stickssticks and and contamination. contamination. ExtendedPosition: o Extended Position: ▪ TheTheneedle needleprotrudes protrudesfromfromthe themodule module only only during during injection. injection. This minimizes ▪ This minimizesexposure exposuretotothe theenvironment, environment,further furthermaintaining maintaining sterility. sterility.
3. Needle 3. Needle Shielding Shielding Mechanism Mechanism Post-injection,the o Post-injection, theneedle needle retracts retracts automatically automatically or isor is manually manually shieldedshielded to prevent reuse and accidental injury. to prevent reuse and accidental injury.
[0038] Thedisclosed
[0038] The disclosedneedle needleactuation actuationmechanism mechanism controls controls thethe precisemovement precise movement of the of the needle between needle betweenitsits retracted retracted and and extended positions. The extended positions. mechanism The mechanism maymay include: include: 1. Stepper Motor 1. Stepper Motor o AA motorized motorizedsystem systemensures ensurescontrolled controlledand andconsistent consistentneedle needlemovement. movement. Thestepper o The stepper motor motorprovides providesincremental incrementalmovements movements for for finefine control, control, minimizingdiscomfort minimizing discomfortduring duringneedle needle insertionand insertion andwithdrawal. withdrawal. 2. Cam Member 2. Cam Member The stepper o The stepper motor motorisis operatively operatively connected connectedtotoaacamcammember. member. Thecam o The camexerts exertsforce forceononthe the needle needleassembly assemblytotomove move thethe needle needle forward (to the extended position) or backward (to the retracted forward (to the extended position) or backward (to the retracted
position). position).
3. Resilient 3. Resilient Bias Bias Theneedle o The needleis is spring-loaded spring-loaded or otherwise or otherwise biasedbiased to return to return to the retracted to the retracted
position when position when not notactively actively engaged. engaged. This ensures o This ensures that that the the needle needle remains remains safely safely housed within the housed within the module module after use, after enhancing use, enhancing safety. safety.
4. Controlled 4. ControlledForce ForceApplication Application Themechanism o The mechanism adjusts adjusts theforce the forceapplied appliedduring duringneedle needlemovement, movement, accommodating varying skin resistances for different patient accommodating varying skin resistances for different patient populations. populations.
[0039] Thedisclosed
[0039] The disclosedelectrically electrically powered drive mechanism powered drive mechanism powers powers movement movement of theof the elastomer diaphragm elastomer diaphragmtotodeliver delivermedicament. medicament.TheThe mechanism mechanism may include: may include: 1. MechanismOperation 1. Mechanism Operation The drive o The drive mechanism mechanism applies applies a pressingforce a pressing forcetotothe theelastomer elastomer diaphragmtotoexpel diaphragm expelthe themedicament medicament through through thethe needle. needle. o During refilling, the During refilling, themechanism creates aa vacuum mechanism creates vacuum totodraw drawmedicament medicament into the reservoir. into the reservoir.
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2. Precision 2. PrecisionControl Control o Themechanism The mechanismis is electricallypowered, electrically powered,allowing allowingforforprecise precisecontrol controlof of diaphragm movement. diaphragm movement. o Themotor The motorspeed speedand andpressure pressuresettings settingsare areprogrammable, programmable, ensuring ensuring accurate dosing and flow rates. accurate dosing and flow rates.
3. Biocompatibility 3. Biocompatibilityand andSafety Safety o Components Components in in contactwith contact withthethemedicament medicament are are made made fromfrom 2025200064
biocompatiblematerials. biocompatible materials. Themechanism o The mechanism is is designed designed to to operate operate without without introducing introducing airair bubbles bubbles into the medicament, maintaining injection quality. into the medicament, maintaining injection quality.
[0040] The
[0040] The disclosed disclosed controller controller may may be be configured configured as aprocessing as a central central processing unit for theunit for the
device, orchestrating device, orchestrating thethe operation operation of various of various components. components. Its capabilities Its capabilities may include: may include:
1. Operation Management 1. Operation Management Thecontroller o The controller manages manages the theneedle needleactuation actuationmechanism, mechanism, drive drive mechanism,and mechanism, and otherintegrated other integratedfeatures. features. o ItIt ensures ensures synchronized operation, such synchronized operation, such asas extending extending the the needle needle before before medicament medicament delivery delivery and retracting and retracting it after it after injection. injection.
2. Activation 2. Activation Mechanism Mechanism Userinput o User input(e.g., (e.g.,pressing pressing a button) a button) triggers triggers the the controller controller to initiate to initiate the the
medicament medicament deliveryprocess. delivery process. Thecontroller o The controller may requireaa predetermined may require predeterminednumber number of of activations activations within aa specified within specified timeframe timeframe to to confirm intent and confirm intent and avoid accidental avoid accidental activation. activation.
3. Feedback 3. Feedback andand Adjustment Adjustment Thecontroller o The controllerreceives receives real-time real-time data data from from sensors sensors (e.g., (e.g., force sensors force sensors
for tissue resistance). for tissue resistance). Basedonon o Based thisdata, this data,it it adjusts adjusts thethe flow flow rate, rate, pressure, pressure, or needle or needle insertion insertion
speed speed to to optimize optimize the the delivery delivery experience. experience. 4. Safety 4. SafetyFeatures Features Includesfail-safes, o Includes fail-safes,suchsuch as as halting halting operation operation if irregularities if irregularities (e.g., (e.g., highhigh
resistance or obstructions) are detected. resistance or obstructions) are detected.
[0041] Inclusive
[0041] Inclusive terminology, terminology, such such as “comprises” as "comprises" and its variations, and its variations, in this specification in this specification
indicate additionalfeatures, indicate additional features, steps, steps, or or components components thatbecan that can be integrated integrated without without excluding excluding
those already those already described. described.
[0042] Thedisclosed
[0042] The disclosedsystem systemmay maybe be modular. modular. Features, Features, components, components, or steps or steps may may be be implemented individuallyororin implemented individually in various various combinations. combinations.For Forexample: example: Oneembodiment • One embodiment of of thethe system system maymay include include the the needle needle actuation actuation mechanism mechanism and drive and drive mechanism without mechanism without thethe adhesive adhesive layer layer forspecific for specificapplications. applications. Anotherembodiment • Another embodiment maymay integrate integrate all all described described features features fora acomprehensive for comprehensive solution. solution.
BRIEF BRIEF DESCRIPTION OFTHE DESCRIPTION OF THEDRAWINGS DRAWINGS Embodiments Embodiments of of thepresent the presentdisclosure disclosurewill willnow nowbebedescribed described byby way way of of example, example, withwith reference to reference to the the accompanying drawings: accompanying drawings:
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[0043] Figure1:1: Top
[0043] Figure Topviewviewofofa amedicament medicament injection injection device device according according to tooneone embodiment. embodiment.
[0044] Figure2:2: Top
[0044] Figure Topviewviewofofa amedicament medicament injection injection device device showing showing a vial a vial connected connected to the device's port. to the device's port.
[0045] Figure
[0045] Figure 3: 3: TopTop view view sectionsection illustrating illustrating the internal the internal components components of the device.of the device.
[0046] Figure 4: Side view of the medicament injection device from Figure1,1,showing
[0046] Figure 4: Side view of the medicament injection device from Figure showing 2025200064
a vial a vial connected connected to to thethe port. port.
[0047] Figure
[0047] Figure 5: 5: Illustration Illustration of the of the adhesive adhesive layer layer for releasable for releasable mounting mounting of the of the moduletotoaa user. module user.
[0048] Figure6:6: Cross-sectional
[0048] Figure Cross-sectional detail detail view view ofof the the medicament injectiondevice medicament injection devicefrom from Figure 1. Figure 1.
[0049] Figure
[0049] Figure 7: Detail 7: Detail view view of theofdevice the device in a retracted in a retracted position. position.
[0050] Figure8:8:Detail
[0050] Figure Detail view viewofofthe the needle needleassembly assemblyininananextended extended position. position.
[0051] Figure9:9: Exploded
[0051] Figure Explodedview view of of thethenovel novel drivemechanism. drive mechanism.
[0052] Figure10:
[0052] Figure 10:Top Topviewviewwithout without housings, housings, showing showing the the drive drive mechanism mechanism and the and the diaphragmoutlet diaphragm outletpump pump pressurizingthetheelastomer pressurizing elastomertotopreparepreparefor fordrawing drawingmedicine medicine from from thethevial. vial.
[0053] Figure
[0053] Figure 11:11: Schematic Schematic representation representation of the elastomer of the elastomer stretched stretched inside the inside torus- the torus-
shaped reservoir, shaped reservoir, as as depicted depicted in Figure in Figure 10. 10.
[0054] Figure12:
[0054] Figure 12:Top Topdetail detail view viewofofwithdrawing withdrawing medication medication fromfrom the the vial, vial, with with the the pumpininvacuum pump vacuum mode mode to draw to draw fluid fluid intointo thethe reservoir. reservoir.
[0055] Figure13:
[0055] Figure 13:Schematic Schematic view view of of thethe process process shown shown in Figure in Figure 12. 12.
[0056] Figure14:
[0056] Figure 14:Schematic Schematicrepresentation representationofofthe theelastomer elastomerbeingbeingstretched stretchedwithin withinthe the torus-shaped reservoir to propel the medication toward the needle tip. torus-shaped reservoir to propel the medication toward the needle tip.
[0057] Figure15:
[0057] Figure 15:Schematic Schematicrepresentation representationofofthe theelastomer elastomerbeingbeingstretched stretchedinside inside the the torus-shaped reservoir to expel the medication through the needle tip, as shown in torus-shaped reservoir to expel the medication through the needle tip, as shown in
Figure 14. Figure 14.
[0058] Figure16:
[0058] Figure 16:TopTopviewview illustratingthe illustrating the membrane membrane switch switch functions. functions.
[0059] Figure17:
[0059] Figure 17:Side Sideview viewofofthe thevial vial and andaa vial vial adapter adapter according accordingto to one one embodiment. embodiment.
[0060] Figure18:
[0060] Figure 18:Perspective Perspectiveview viewofofthe thevial vialadapter adapterfrom fromFigure Figure17. 17.
[0061] Figure19:
[0061] Figure 19:Perspective Perspectiveview viewofofthe themedicament medicament injection injection device device from from Figure Figure 1, 1, withaavial with vialaligned alignedforforinsertion insertionintointo thethe connection connection port. port.
[0062] Figure20:
[0062] Figure 20:Illustration Illustration ofofthe therubber rubbercomponent throughwhich component through whichthe theLuer LuerFemale Female bracket/vial assembly bracket/vial assembly is is inserted inserted intointothetheMale Male Luer Luer Lock within the Lock within the on-body on-body top top housing. housing.
Detailed Detailed Description Description of of Embodiments Embodiments
[0063]
[0063] InIn the the drawings, drawings, reference reference numeral 15generally numeral 15 generallydesignates designatesaamedicament medicament injection device in accordance with the present disclosure. As illustrated in Figures 1 injection device in accordance with the present disclosure. As illustrated in Figures 1
and 2, and 2, the the medicament injectiondevice medicament injection device(15) (15) includes includesthe the components components described described herein. herein.
[0064] Theterm
[0064] The term"medicament" "medicament" as as used used in in thisdisclosure this disclosurerefers refersto to any any substance, substance, such such as aa drug, as drug,that thatisis suitable suitablefor forinjection injectioninto intoa apatient patient forfor thethe treatment treatment of a of a condition condition or or disease. The disease. The medicament medicament may may be be in in liquidform liquid form andand maymay include include an active an active pharmaceuticalingredient pharmaceutical ingredientalong alongwith withananexcipient excipientor or formulation formulationbuffer. buffer.
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[0065] Referring
[0065] Referring to to Figures Figures 6 9, 6 and andthe9,reservoir the reservoir (170) (170) definesdefines an internal an internal volume for volume for
holding aa liquid holding liquid medicament. medicament. TheThereservoir reservoir(170) (170)incorporates incorporatesan anelastomer elastomerdiaphragm diaphragm (460), (460), anan air airdiffuser diffuserdiaphragm diaphragm (420), (420), and and aa pressure-building pressure-building chamber (430). These chamber (430). These componentsare components areseamlessly seamlesslyintegrated integratedthrough througha alow-pressure low-pressure injectionmoulding injection moulding process,ensuring process, ensuring precise precise construction construction and optimal and optimal functionality. functionality.
[0066] In one
[0066] In embodiment,thetheelastomer one embodiment, elastomer diaphragm diaphragm (460) (460) is ais flexible a flexiblemembrane membrane 2025200064
composedofofsoft, composed soft, durable durablematerials materials capable capableof of withstanding withstandingrepeated repeateddeformation deformation whileretaining while retainingitsitsoriginal originalshape. shape. It It stretches stretches in response in response topressure to air air pressure generated generated by by the diaphragm the micropump diaphragm micro pump (520). (520). An An air air diffuser(420) diffuser (420)evenly evenly distributesthe distributes theapplied applied pressure across pressure across the the diaphragm, ensuringuniform diaphragm, ensuring uniformstretching stretchingandandminimizing minimizing localized localized stress stress points. points.AApressure-building pressure-building chamber (430) creates chamber (430) creates aa controlled controlled environment environment forfor consistentand consistent andreliable reliable pressure pressure delivery, delivery, enabling enabling dependable dependable operation.operation.
[0067] The
[0067] The curved curved wallwall of theof torus the torus structure structure (170) (170) providesprovides structural structural support and support and
optimizes pressure channellings, optimizes pressure channellings, contributing contributing toto the the device's device'scompact compact design. design. This This minimizes minimizes thethe overall overall sizesize of the of the bodybody injector, injector, allowing allowing users tousers to perform perform light tasks light tasks
while wearing while wearingthe thedevice. device. TheTheelastomer elastomerdiaphragm diaphragm (460) (460) dynamically dynamically adjusts adjusts to to pressure variations pressure variations generated generated by by the the diaphragm diaphragm airair pump pump(520), (520),enhancing enhancing its its responsiveness. responsiveness.
[0068] Combined
[0068] Combined Description Description of of Device Device Operation Operation and and Controller Controller Interface: Interface: Referring Referring to Figures to Figures 1010 through through 15, 15, the the device device facilitates facilitates medicament medicament injectioninjection through three through three
preparatorysteps. preparatory steps.These These steps steps are executed are executed via a controller via a controller interface interface equippedequipped with with tactile switches (670, 690, and 700), each designed for specific user actions. tactile switches (670, 690, and 700), each designed for specific user actions.
Steps for Medicament Steps for Injection: Medicament Injection:
1. Activationof 1. Activation of the the Pump Pump(Figures (Figures1010andand 11): 11): The process begins when the user pressesSwitch The process begins when the user presses Switch670,670,activating activatingthethe pump(520) pump (520)totoapply applypressure pressuretotothethe elastomer elastomerdiaphragm diaphragm (460).This (460). This stretches thediaphragm stretches the diaphragm fully fully along along the torus the torus wall it wall until until it reaches reaches the the endpoint within endpoint within thethe reservoir reservoir (170). (170).
2. Drawing 2. Drawing Medicament Medicament into into the the Reservoir Reservoir (Figures (Figures 12 13): 12 and and 13): Theuser The user then then presses presses Switch Switch690, 690,which whichswitches switchesthe thepump pump (520) (520) to to vacuummode. vacuum mode. ThisThis creates creates suction,causing suction, causingthetheelastomer elastomerdiaphragm diaphragm (460) (460) totoreturn returntotoitsitsoriginal originalposition position while while drawing drawing the medicament the medicament
from thevial from the vial(110) (110) into into thethe reservoir reservoir (170). (170).
3. Expelling 3. Expellingthe theMedicament Medicament (Figures (Figures 14 and 14 and 15):15): Finally, the Finally, theuser userpresses presses Switch Switch 700,700, activating activating the(520) the pump pumpto(520) to gradually apply pressure. This action stretches the elastomer gradually apply pressure. This action stretches the elastomerdiaphragm diaphragm (460) forward within (460) forward within thethe reservoir, reservoir, expelling expelling thethemedicament through medicament through the needle tip (490). the needle tip (490).
4. Controller 4. ControllerInterface Interface Functions: Functions: o Switch 670:Activates Switch 670: Activatespressure pressuretotostretch stretch the the elastomer diaphragm. elastomer diaphragm. o Switch 690:Activates Switch 690: Activatesvacuumvacuum mode mode to draw to draw medicament medicament into theinto the reservoir. reservoir.
o Switch 700:Activates Switch 700: Activatesthe the needle needle mechanism mechanism andand expels expels thethe
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medicament. medicament.
[0069] Referring to
[0069] Referring to Figures Figures 6, 6, 7, 7,and and8, 8,the needle the needleassembly assembly(240) (240)includes includesa aLuer LuerLock Lock Femalesyringe Female syringe(300) (300)connected connectedtotoa aMale MaleLuer Luer Lock Lock connector connector (310). (310). The The connector connector slides alonga arailing slides along railingintegrated integrated into into thethe bottom bottom housing housing (210). (210). The(300) The needle needle is (300) is
movablerelative movable relative to to the the module (200)between: module (200) between: o AA retracted retracted position, position, where where the the needle needle tip tip(300) (300)remains remains housed within the housed within the 2025200064
module. module. o AnAnextended extendedposition, position,where wherethetheneedle needletip tip (300) (300) protrudes protrudes from fromthe the module. module. The assembly The assemblyisisdriven drivenby byaastepper stepper motor motor(340), (340),enabling enablingadjustable adjustable penetration depth to suit various patient morphologies. penetration depth to suit various patient morphologies.
[0070] Themodule
[0070] The module(200) (200)features featuresa aLuer LuerLock Lock port(350) port (350) fluidlycoupled fluidly coupledtotothe the reservoir(170). reservoir (170).This Thisport port facilitates facilitates secure secure connection connection to a medicament to a medicament source, source, such as such as aa vial vial (110), asdepicted (110), as depictedininFigure Figure 2. adhesive 2. An An adhesive layer layer (220) ensures (220) ensures the disposable the disposable
moduleisis securely module securely mounted mountedtotothe theuser's user’sskin. skin.
[0071] In one
[0071] In embodiment,thetheadhesive one embodiment, adhesive layer(220) layer (220)isiscovered coveredwith witha aremovable, removable, non- non- adhesive film (70) adhesive film (70) to to ensure ensure easy easy application application and and removal. Thehousing removal. The housing(200) (200)includes includes a window a (10)that window (10) that allows allowsthe the user user to to view the reservoir view the reservoir (170) (170) and and monitor the monitor the medicamentvolume medicament volume during during operation. operation.
[0072] Thecontroller
[0072] The controller (120) (120) operatively operatively manages theneedle manages the needleactuation actuation mechanism mechanism (340) (340) and the and the diaphragm air pump diaphragm air pump(530), (530),regulating regulatingparameters parameterssuch such asas thevelocity the velocityand and displacementofof the displacement the needle needle (300) (300) and andthe the elastomer elastomerdiaphragm diaphragm (460).The (460). The controllerisis controller further configured further configured to to adjust adjust needle needle insertion insertion depthdepth based based on useron user or inputs inputs or physiological physiological
parameters, including parameters, including body bodymass massindex index(BMI), (BMI), age, age, or or gender. gender.
[0073] Thecontroller
[0073] The controller (120) (120) ensures ensures proper proper sequential sequential execution execution of of operations operations and and provides user feedback through visual and auditory indicators. Status indicators include provides user feedback through visual and auditory indicators. Status indicators include
red and red green lights, and green lights, where where a a green green light lightor orcheckmark confirmstask checkmark confirms task completion. completion.
[0074] Thedrive
[0074] The drive mechanism mechanism (315) (315) maintains maintains a consistentflow a consistent flow rateduring rate duringmedicament medicament injection bycontrolling injection by controlling thethe velocity velocity of the of the elastomer elastomer diaphragm diaphragm (460). (460). Flow rate Flow rate
adjustments adjustments maymaybebeuser-defined user-definedororpreconfigured preconfiguredbybya aphysician. physician.TheThesystem systemisisfurther further configured to configured to dynamically dynamicallymodulate modulate flow flow ratestotooptimize rates optimizepatient patientcomfort comfortand and therapeuticeffectiveness. therapeutic effectiveness.
[0075] In certain
[0075] In certain embodiments, embodiments, the thedevice deviceincorporates incorporatessensors sensorsoperable operabletotomonitor monitor parameters such as tissue resistance, temperature, or pressure. These sensors are parameters such as tissue resistance, temperature, or pressure. These sensors are
communicatively linked communicatively linked to thetocontroller the controller (120) (120) to to facilitate facilitate real-time real-time adjustments adjustments for for optimal medicament optimal medicament delivery. delivery.
[0076] Thedevice
[0076] The deviceincludes includesaa communication communication unit unit enabling enabling wireless wireless connectivity connectivity with with external external devices, devices, such such as as smartphones, for remote smartphones, for monitoringand remote monitoring andparameter parameter configuration. Settings configuration. Settingssuch such as asdose dose volume and injection volume and injection speed maybebemodified speed may modifiedviaviaa a
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dedicated application. dedicated application.
[0077] Themodular
[0077] The modulardesign designofofthe thedevice device(200) (200)promotes promotes enhanced enhanced usability, usability, precision, precision, and patient and patient comfort. comfort. The described embodiments The described embodimentsareare illustrativeand illustrative andnon-limiting, non-limiting, allowing variations allowing variations without departing from without departing fromthe the scope scopeof of the the disclosed disclosed technology. technology.
[0078]
[0078] InIn the the illustrated illustratedembodiment, embodiment, as as shown shown in in Fig. Fig. 16, 16, the the activation activationmechanism mechanism 2025200064
comprises comprises first,second, first, second, andand thirdthird tactile tactile switches switches (670,(670, 690,located 690, 700) 700) located on the on the
controllerinterface. controller interface.These These tactile tactile switches switches are are operable operable to trigger to trigger activation activation of the of the drive drive
mechanism (300) in response to user input. The first tactile switch (670) is configured mechanism (300) in response to user input. The first tactile switch (670) is configured
to initiate to initiate activation activation of ofthe thedrive drivemechanism mechanism to apply to apply pressurepressure via the via the elastomer, elastomer,
thereby displacing thereby displacing the the medicament medicament towardtoward thethedistal distalend endofofthethe reservoir reservoir (110). (110). The The secondtactile second tactileswitch switch (690) (690) triggers triggers activation activation of theofdrive the drive mechanism mechanism (315, Fig.(315, Fig. 14) to 14) to
release air release airpressure pressureandandextract extract medicament medicament from from thethe medicament containerororvial. medicament container vial. The The third tactile third tactile switch switch(700) (700)activates activates thethe needle needledeployment deploymentmechanism, expelling the mechanism, expelling the liquid medicament liquid medicament from fromthetheinternal internalreservoir reservoir volume volume(170)(170)through throughthetheneedle needle assembly(490). assembly (490).
[0079] The
[0079] The controller controller (120,(120, 160)160) is configured is configured to enable to enable operationoperation of the drive of the drive
mechanism mechanism (315, (315, FIG. FIG. 10)10) and and associated associated components components (530, (530, 340)340) uponupon receiving receiving a a predetermined sequence of inputs via one of the tactile switches (670, 690, or 700) predetermined sequence of inputs via one of the tactile switches (670, 690, or 700)
within aa predetermined within activation window. predetermined activation window.The The activationwindow activation window may may rangerange from from approximately3 3toto 10 approximately 10seconds, seconds,withwith55seconds secondsbeing beinga arepresentative representativeexample. example.The The controllerinterface controller interface(120,(120, 160160 FIG FIG 3) incorporates 3) incorporates visual visual indicators indicators (e.g., (e.g., red and red and green green
lights) associated lights) associatedwith with each each tactile tactile switch switch (670, (670, 690, 690, 700 700 Fig Figwhich 16), 16 ),provide which provide feedbackonon feedback user user interactions. interactions. A redA light red light indicates indicates task initiation, task initiation, transitioning transitioning to green to green
upontask upon task completion. completion.The Thedevice device(200)(200)maymay also also include include auditory auditory and/or and/or haptic haptic indicators indicators totosignal signalactivation activation ofof thethe drive drive mechanism. mechanism. If a tactile If a tactile switchswitch is pressed is pressed five five timeswithin times withinthethe activation activation window, window, theistask the task is armed, armed, as indicated as indicated by the redbylight. the redIf light. If
the sequence the sequence is is incomplete incomplete when whenthe theactivation activationwindow window elapses, elapses, thethecontroller controllerresets resets the count the count to to zero, zero,preventing preventing activation activationof ofthethedrive mechanism drive mechanism (315, (315, FIG. 14) and FIG. 14) and allowingthetheuser allowing user to to abort abort thethe process. process.
[0080] Thebody
[0080] The bodyinjector injectordevice device(200) (200)addresses addressesthe thechallenges challengesofofdose dosevolume volume and and viscosity of viscosity of medicaments inthe medicaments in the following followingways: ways:
1. Enhanced Pump 1. Enhanced PumpMechanism Mechanism forfor High-ViscosityMedicaments: High-Viscosity Medicaments: The device is equipped with a robust pump (520) capable The device is equipped with a robust pump (520) capable of of generating generating sufficient sufficient pressure to pressure to overcome themechanical overcome the mechanicalresistance resistanceposed posedbybyhigh-viscosity high-viscosity medicaments.This medicaments. Thisensures ensuresreliable reliabledelivery delivery even even forfor dense dense biological biological formulations, formulations, facilitating subcutaneous facilitating subcutaneous injection injection without without manualmanual effort effort from thefrom user.the user.
2. Controlled 2. ControlledElastomer Elastomer Diaphragm Diaphragm System: System: Theelastomer The elastomerdiaphragm diaphragm (460) (460) plays plays a critical role a critical role in in mediating pressure mediating pressure application.Its application. Itsflexibility flexibilityallows allowsthethepump pump to gradually to gradually and evenly and evenly apply pressure, apply pressure,
minimizingsudden minimizing sudden burststhat bursts thatcould coulddamage damage tissueororhinder tissue hindermedicament medicament dispersion. This dispersion. This controlled controlled mechanism accommodates mechanism accommodates the the uniqueunique flowflow characteristics of high-viscosity formulations. characteristics of high-viscosity formulations.
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3. Larger 3. LargerDose DoseVolumes Volumes withwith Precision Precision Delivery: Delivery: Thedevice's The device's reservoir reservoir (170) (170) and and elastomer diaphragmare elastomer diaphragm aredesigned designedtotohandle handle volumesgreater volumes greaterthan thanthe the conventional conventional22mL mLlimit limitfor forsubcutaneous subcutaneousinjections. injections.By By evenly distributing evenly distributing pressure pressure across across the thediaphragm and leveraging diaphragm and leveragingprecise precise control control through the tactile switches (670, 690, and 700), the device ensures the accurate and through the tactile switches (670, 690, and 700), the device ensures the accurate and
gradual delivery gradual delivery of of larger larger medicament volumes. medicament volumes. 4. Minimized 4. Minimized Tissue Tissue Resistance Resistance and and Improved Improved Absorption: Absorption: 2025200064
Thegradual The gradualand andsteady steadyexpulsion expulsionofofmedicament medicament through through the the needle needle tiptip (490) (490) mitigates tissue resistance during injection. This enhances the dispersion and mitigates tissue resistance during injection. This enhances the dispersion and
absorption of absorption of the the medicament, makingititsuitable medicament, making suitable for for subcutaneous deliveryeven subcutaneous delivery eveninin challenging cases challenging cases where wherehigher higherviscosity viscosity would wouldotherwise otherwiseimpede impede effectiveness. effectiveness. 5. Adaptabilityfor 5. Adaptability for Biological BiologicalMedicaments: Medicaments: Thedesign The designanticipates anticipates thethe requirements requirements ofof biological biological medicaments, suchasashigh medicaments, such high concentrations. The device ensures that the increased viscosity does not concentrations. The device ensures that the increased viscosity does not
compromise compromise thetheinjection injectionprocess, process,thereby therebysupporting supportingsubcutaneous subcutaneous therapeutic therapeutic needs. needs.
Throughthese Through thesefeatures, features, the the device device (200) effectively overcomes (200) effectively the limitations overcomes the limitations of of conventionalinjection conventional injection devices, devices, enabling enabling the the delivery delivery of of high-viscosity high-viscositymedicaments medicaments and larger and larger dose dose volumes withprecision volumes with precisionand andease. ease.
[0081] In certain
[0081] In certain embodiments, embodiments, thethemedicament medicament delivery delivery rateisisadjustable. rate adjustable. High Highflow flow rates can increase tissue stress at or near the injection site, potentially intensifying rates can increase tissue stress at or near the injection site, potentially intensifying
perceivedpain. perceived pain. Limiting Limiting the the flowflow rate rate during during initial initial or final or final injection injection phasesphases can reduce can reduce
such discomfort. Additionally, reducing the flow rate near the end of the injection may such discomfort. Additionally, reducing the flow rate near the end of the injection may
enhancemedicament enhance medicament absorption absorption by by minimizing minimizing tissue tissue saturation. saturation.
[0082] Thedrive
[0082] The drive mechanism mechanism (315, (315, Fig. Fig. 14)cancan 14) maintain maintain a constant a constant flow flow rateofofthe rate the medicamentbyby medicament ensuring ensuring consistentelastomer consistent elastomer velocityduring velocity duringinjection. injection.Flow Flowrates ratesmay may be set by a predefined injection protocol, configured by a physician, or adjusted based be set by a predefined injection protocol, configured by a physician, or adjusted based
on user preferences. The device may also support variable flow rates, reducing the rate on user preferences. The device may also support variable flow rates, reducing the rate
during initial and/or during initial and/orfinal finalphases phasesof of thethe injection injection to optimize to optimize comfort comfort and effectiveness. and effectiveness.
Sensors integrated into Sensors integrated into the the device device may dynamicallyadjust may dynamically adjustthe the flow flowrate rate based based onon real- real- time feedback. time feedback.
[0083] Thedevice
[0083] The device(200) (200)incorporates incorporatesone oneorormore moresensors, sensors,including includingmicroswitches, microswitches, electrostatic sensors, capacitive sensors, optical sensors, IR sensors, and magnetic electrostatic sensors, capacitive sensors, optical sensors, IR sensors, and magnetic
sensors. These sensors. sensors monitor These sensors monitorparameters parameterssuchsuchasastemperature, temperature,pressure, pressure,motion, motion, orientation, and electromagnetic properties, relaying data to the controller (160, 120). orientation, and electromagnetic properties, relaying data to the controller (160, 120).
[0084] Sensor
[0084] Sensor data data enables enables the controller the controller to assess to assess the operational the operational state ofstate of the device the device
andprovide and provide user user feedback feedback via visual, via visual, haptic, haptic, or auditory or auditory indicators. indicators. For instance, For instance, a a visual indicator visual indicatormay may display display readiness readiness for injection for injection or errors or errors in device in device functionality. functionality.
[0085] Sensorsassociated
[0085] Sensors associated with withthe the drive drive mechanism mechanism maymay monitor monitor tissue tissue resistance resistance or or elastomer movement. elastomer movement. A A force force sensor sensor maymay measure measure resistance resistance opposing opposing the drive the drive force, force, while sensors while sensors detecting detecting electrical electricalcurrent currentcan canassess thethe assess power powerrequired requiredfor medicament for medicament
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delivery. Additional sensors may monitor pressure within the reservoir to facilitate delivery. Additional sensors may monitor pressure within the reservoir to facilitate
optimized delivery of optimized delivery of high-viscosity high-viscosity medicaments. medicaments.
[0086] Thedevice
[0086] The devicemay mayalso alsoinclude includesensors sensorsfor formonitoring monitoringbattery batterycharge chargelevels levelsoror detecting detecting a a connection with external connection with external devices, devices, such such as as smartphones smartphones oror computers, computers,via via wireless communication wireless protocols. communication protocols. 2025200064
[0087] Themedicament
[0087] The medicament port port (350) (350) is is designed designed toto connect connect with with a vial(110) a vial (110)and andmay may include include a aprotective protective cover cover to prevent to prevent contamination. contamination. A vial (710) A vial adaptor adaptor (710) facilitates facilitates a a secure fluid connection between the vial and the reservoir. The adaptor includes secure fluid connection between the vial and the reservoir. The adaptor includes
connectors suchas connectors such as Luer Luerfittings, fittings, which which engage with the engage with the corresponding correspondingportport components. components.
[0088] Uponsecuring
[0088] Upon securingthe thevial vial (110) (110) to to the the port port (680), (680), the thedrive drivemechanism activates aa mechanism activates vacuumpump, vacuum pump, creating creating a retractingforce a retracting forcethat that moves movesthe theelastomer elastomertotodraw drawthe the medicamentinto medicament intothe thereservoir. reservoir.
[0089] Thereservoir
[0089] The reservoir (170) features aatoroidal (170) features toroidaldesign designcapable capableofofholding holdingup uptoto75 75mL mL ofof medicament.ItItincludes medicament. includesconnectors connectorsforforfluid fluid tubing, tubing, incorporating incorporating one-way valvestoto one-way valves regulate flow regulate flow and maintain sterility. and maintain sterility. The Theinternal internalvolume volume accommodates accommodates a a wide wide range range of of doses, doses, including including configurations configurations for for both both small small (1 (1 mL) and large mL) and large (75 (75 mL) mL)volumes. volumes.
[0090]
[0090] AAcommunication communication unitunit enables enables wireless wireless interactionwith interaction withexternal externaldevices devicessuch suchasas smartphones, health smartphones, health monitors, monitors, or servers. or servers. Thiscan This unit unit can transmit transmit operational operational data, data, including injection including injection parameters, parameters, device device status, status, and alerts, and alerts, to stakeholders to stakeholders such as such as
physicians,pharmacists, physicians, pharmacists, or caregivers. or caregivers.
[0091] External
[0091] External devices devices can can also also transmit transmit commands commands to adjust to adjust settings, settings, such as delivery such as delivery
rate, needle rate, needle insertion insertiondepth, depth,oror medicament medicament temperature range, enabling temperature range, enabling remote remote configuration. configuration.
[0092] Thedescribed
[0092] The describeddevice device(200) (200)enhances enhances control control over over both both medicament medicament fillingfilling and and injection, injection,offering offeringprecise preciseadjustments adjustments for forvolume, volume, speed, speed, and needle depth and needle depthtotoimprove improve patient comfort patient comfortandand usability. usability.
[0093] Variations and
[0093] Variations and modifications modificationsto to the the described described embodiments arewithin embodiments are withinthe thescope scope of of the the claims claims and and the the general general inventive inventive concept, concept, as as would would be be understood understood bybythose those skilled in the skilled in the art. art.
[0094] Throughoutthis
[0094] Throughout thisspecification specification the the word "comprise",ororvariations word "comprise", variations such such asas "comprises" "comprises" or or "comprising", "comprising",will will be be understood understoodtotoimply implythetheinclusion inclusionof of aa stated stated element, integeroror element, integer step, step, or or group group of elements, of elements, integers integers or steps, or steps, but notbut thenot the exclusion exclusion
of anyother of any otherelement, element, integer integer or step, or step, or group or group of elements, of elements, integers integers or steps. or steps.
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[0095]
[0095]REFERENCES CITED REFERENCES CITED
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FDA(Food FDA (Food andand DrugDrug Administration) Administration) SafetySafety Communication Communication (2023).(2023). “Potential "Potential Inaccuracies with Inaccuracies with Certain Certain Syringes Syringes in in High-Pressure High-PressureInfusion InfusionSettings." Settings.” Available at: Available at: www.FDA.gov www.FDA.gov (Search (Search “Safety "Safety Communications”) Communications") 3. Inconsistent Flow 3. Inconsistent Flow Rates Rates MarkSL, Mark SL,Bennett BennettT,T,Richards Richards A,A, etetal. al. (2024). (2024). "Assessing “AssessingSyringe Syringe'Stiction': ‘Stiction’: Clinical Impact Clinical of Plunger Impact of Resistance on Plunger Resistance onFlow FlowAccuracy." Accuracy.” Journal Journal of of Infusion Infusion Nursing, 47(1): Nursing, 47(1): 12-19 12–19 4. High 4. High ViscosityMedications Viscosity Medications SahasrabudheV,V,etetal. Sahasrabudhe al. (2022). (2022). “Assessing "Assessing the the Risk Riskofof Backflow Backflowand andCross- Cross- ContaminationininMulti-Port Contamination Multi-PortIVIVAccess Access with with Syringe Syringe Injections.”Journal Injections." Journal of of Hospital Infection, 127: 121–127. Hospital Infection, 127: 121-127. FDASafety FDA SafetyCommunication Communication (2023). (2023). “Potential "Potential Inaccuracies Inaccuracies withwith Certain Certain Syringes Syringes in in High-Pressure InfusionSettings." High-Pressure Infusion Settings.” FDA.gov. FDA.gov. 5. Extended 5. Extended InjectionTimes Injection Times GuptaP, Gupta P, et et al. al.(2021). (2021)."Subcutaneous Infusion for "Subcutaneous Infusion for Large-Volume Biologics: Large-Volume Biologics: Challenges Challenges and andInnovations." Innovations."Current CurrentDrug Drug Delivery, Delivery, 18(5): 18(5): 23–32. 23-32. 6. Patient 6. PatientComfort Comfortand andAdherence Adherence MarkSL, Mark SL,etetal. al. (2024). (2024). "Assessing “AssessingSyringe Syringe'Stiction': ‘Stiction’: Clinical Clinical Impact Impact of of Plunger Plunger Resistance on Resistance on Flow FlowAccuracy." Accuracy.” Journal Journal of of InfusionNursing, Infusion Nursing, 47(1): 47(1): 12– 19. 12-19. 7. Risk 7. Risk of Injection of Injection SiteSite Leakage Leakage MoogR,R,etetal. Moog al. (2020). (2020). "Assessment "Assessment ofofInjection InjectionSite Site Leakage LeakageininLarge-Volume Large-Volume SubcutaneousDelivery." Subcutaneous Delivery."Journal JournalofofPharmaceutical Pharmaceutical Sciences, Sciences, 109(3): 109(3): 876– 876- 884. 884. 8. Complexity 8. Complexity and Lack and Lack of Intuitive of Intuitive Interfaces Interfaces BrownA,A,etetal. Brown al. (2023). (2023). "Simplifying "Simplifying Drug DrugPreparation Preparationfor forWearable Wearable Injectors:A A Injectors: User-CentricApproach." User-Centric Approach."Journal Journal of of Advanced Advanced Medical Medical Devices, Devices, 9(6):9(6): 432-432– 441. 441. 9. Dead 9. Dead Space Space andand Medication Medication Waste Waste KleinbergM. Kleinberg M.(2021). (2021)."Dead "Dead Space Space Volume Volume and Medication and Medication Waste Waste in Auto- in Auto- Injectors." Therapeutic Injectors." Therapeutic Delivery, Delivery, 12(7): 12(7): 541–550. 541-550. 10. LimitedVolume 10. Limited VolumeRangeRange Patel R, Patel R, et etal. (2021). al. (2021)."Engineering "EngineeringLarge-Volume Injectors for Large-Volume Injectors for Subcutaneous SubcutaneousDrug Drug Delivery." Drug Delivery." DrugDesign Designand and Delivery Delivery Insights,14(3): Insights, 14(3):187-201. 187–201. 11. Lack 11. Lack of of Connectivity Connectivity andand Monitoring Monitoring WilsonK,K,etet al. Wilson al. (2020). (2020). "The "The Role Role ofof IoT IoT inin Modern Subcutaneous Modern Subcutaneous DrugDrug Delivery Devices."Internet Delivery Devices." Internet ofof Medical ThingsJournal, Medical Things Journal,12(5): 12(5):214-223. 214–223. 12. Needle 12. Needle Safety Safety andand Reuse Reuse RisksRisks BlackmoreP,P,etetal. Blackmore al. (2022). (2022). "Analyzing "AnalyzingNeedle NeedleFailure FailureininWearable Wearable Injectors."Journal Injectors." Journal of Medical of DeviceDesign, Medical Device Design,15(8): 15(8):341-349. 341–349. 13. Power 13. Power andand Portability Portability Challenges Challenges
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Sanchez Sanchez M,M,etetal. al. (2020). (2020). "Economic BarriersininAccessing "Economic Barriers AccessingSubcutaneous Subcutaneous DrugDrug Delivery Technologies."Health Delivery Technologies." HealthEconomics Economics and and Therapeutics, Therapeutics, 10(3): 10(3): 218–224. 218-224. 14. Temperature 14. Temperature Sensitivity Sensitivity Lee H, Lee H, et et al. al.(2023). (2023)."Advancing Subcutaneous "Advancing Subcutaneous DrugDrug Delivery Delivery Through Through Real-Real- Time Time Physiological Monitoring." Physiological Monitoring."Advanced Advanced Therapeutic Therapeutic Technologies, Technologies, 16(9): 16(9): 589- 589– 601. 601. 15. Disposal and 15. Disposal and Environmental Environmental Concerns Concerns 2025200064
Sharma Sharma S,S,etetal. al. (2023). (2023). "Environmental Impact "Environmental Impact of of Medical Medical Waste Waste from from Single- Single- Use Use Injectors." Injectors."Journal Journal ofofEnvironmental Health, 85(9): Environmental Health, 85(9): 233-241. 233–241. 16 Injection 16 Injection PainPainandand Patient Patient Anxiety Anxiety DavidsonJ,J,etetal. Davidson al.(2020). (2020)."Psychological "Psychological andand Physical Physical Barriers Barriers to Subcutaneous to Subcutaneous Injections." Injections." Pain Pain Management, 10(5):295-303. Management, 10(5): 295–303. 17. Limited 17. Limited PatientEducation Patient Education andand Support Support Grant T, Grant T, et et al. al.(2021). (2021)."Improving "Improving Patient Patient Training Training for forWearable DrugDelivery Wearable Drug Delivery Devices." Journalof Devices." Journal of Patient-Centered Patient-CenteredCare,Care,6(4): 6(4):189-199. 189–199. 18. Compliance 18. Compliance withwith Regulatory Regulatory Standards Standards KearneyL,L,etet al. Kearney al. (2021). (2021). "Navigating RegulatoryHurdles "Navigating Regulatory Hurdlesfor forSubcutaneous Subcutaneous Delivery Devices."Medical Delivery Devices." MedicalDevice Device Regulations Regulations Quarterly, Quarterly, 27(4): 27(4): 155–163. 155-163. 19. Challenges 19. Challenges in in Infusion Infusion SiteSelection Site Selection JacksonL, Jackson L, et et al. al.(2022). (2022)."Adhesive "Adhesive Challenges Challenges in in Reusable ReusableSubcutaneous Subcutaneous Delivery Devices."Journal Delivery Devices." JournalofofBiomedical BiomedicalAdhesives, Adhesives, 11(9):145-153 11(9): 145–153
Claims (43)
1. A fluid delivery system for injecting a medicament into a patient, the system comprising: a reservoir assembly having an internal volume for holding medicament, and an elastomer diaphragm arranged across the internal volume; an electrically powered drive mechanism configured to generate airflow to controllably cause the elastomer diaphragm to retract to draw the medicament 2025200064
into the internal volume of the reservoir assembly, or to stretch to expel the medicament from the internal volume of the reservoir assembly to be injected into the patient; a pressure chamber defining a sealed compartment with the elastomer diaphragm and configured to maintain uniform pressure on, and regulate deformation of, the elastomer diaphragm; and a controller configured to actuate the electrically powered drive mechanism to controllably cause the elastomer diaphragm to retract or stretch; wherein the electrically powered drive mechanism is operable to maintain a constant flow rate of the medicament during injection by effecting consistent velocity of the elastomer diaphragm.
2. The system of claim 1, wherein the controller is configured to operate the electrically powered drive mechanism according to: i) a pressure mode, wherein the airflow applies a pressure to the elastomer diaphragm to stretch the elastomer diaphragm; and ii) a vacuum mode, wherein the airflow applies a vacuum to the elastomer diaphragm to retract the elastomer diaphragm.
3. The system of any of claims 1 or 2, wherein the pressure chamber comprises a thermal regulation feature to maintain a consistent pressure across variable temperature environments.
4. The system of any of claims 1 to 3, wherein the reservoir assembly further comprises an air diffuser diaphragm configured to distribute the controlled airflow evenly across a surface of the elastomer diaphragm.
5. The system of claim 4, wherein the air diffuser diaphragm is configured with micro-perforations.
6. The system of any of claims 1 to 5, wherein the controller comprises an interface having one or more physical switches for operation of the electrically powered drive mechanism by a user.
7. The system of claim 6, wherein the controller is configured to operate the electrically powered drive mechanism by: in response to a first actuation of the one or more switches, activating the electrically powered drive mechanism to cause the elastomer diaphragm to stretch along an inner wall of the internal volume until it reaches an endpoint;
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in response to a second actuation of the one or more switches, activating the vacuum mode to cause the elastomer diaphragm to return to an original position prior to the first actuation while drawing the medicament into the reservoir; and in response to a third actuation of the one or more switches, activating the electrically powered drive mechanism to cause the elastomer diaphragm to stretch forward within the reservoir, expelling the medicament into the patient. 2025200064
8. The system of any of claims 1 to 7, wherein the reservoir assembly is configured to draw the medicament from an external container, and wherein the medicament is expelled from the reservoir assembly into the patient via a needle assembly.
9. The system of any of claims 1 to 8, wherein the controller is configured to adjust the operation of the electrically powered drive mechanism to cause the elastomer diaphragm to expel the medicament at an optimum flow rate.
10. The system of any of claims 1 to 9, wherein the controller is configured to regulate the delivery of the medicament to the patient based on a variation in pressure, airflow, and/or operational conditions of the system.
11. The system of any of claims 1 to 10, wherein the reservoir assembly is configured as a single integrated component or as one or more modular units that can be added, replaced, or upgraded independently.
12. The system of claim 11, wherein the modularity of the reservoir assembly allows for one or more of: the integration of one or more additional components; and a replacement of one or more individual parts.
13. The system of claim 12, wherein the reservoir assembly, when configured as a single integrated component, minimizes or reduces material interfaces and potential leakage points.
14. The system of any of claims 11 to 13, wherein the reservoir assembly, when configured as one or more modular units, allows for incremental enhancements, including one or more of: a higher-capacity reservoir; an advanced elastomer diaphragm material, and precision-engineered pressure or diffuser components.
15. The system of any of claims 1 to 14, wherein the electrically powered drive mechanism is configured with a withdrawal pressure, or wherein the system further comprises one or more electric or manual valve mechanisms configured to provide a withdrawal pressure release mechanism.
16. The system of any of claims 1 to 15, wherein the electrically powered drive mechanism further comprises a variable-speed motor to adapt the intensity of the controlled airflow.
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17. The system of any of claims 1 to 16, wherein the reservoir assembly further comprises one or more advanced sealing mechanisms to mitigate fluid leakage under high- pressure conditions.
18. The system of any of claims 1 to 17, wherein the elastomer diaphragm is fabricated from one or more materials that are chemically resistant to corrosive or volatile substances. 2025200064
19. The system of any of claims 1 to 18, wherein the reservoir assembly further comprises one or more sensors configured to perform real-time monitoring of one or more of a tissue resistance, an internal pressure of the reservoir, and a medicament flow rate.
20. The system of claim 19, further comprising a communication unit configured to wirelessly connect with at least one external device, wherein the external device is configured to receive data associated with the real-time monitoring.
21. The system of any of claims 1 to 20, wherein the elastomer diaphragm comprises one or more wear indicators.
22. A medicament injection device comprising a disposable module with: a reservoir defining an internal volume to hold a medicament, and having an elastomer diaphragm arranged across the internal volume; a port connection for fluid coupling with a medicament source; a needle assembly, including a needle movable between: a retracted position in which the needle is housed within the module; and an extended position in which the needle protrudes from the module; an adhesive layer for releasable attachment to a user; a needle actuation mechanism operable to move the needle between the retracted and extended positions; a pressure chamber defining a sealed compartment with the elastomer diaphragm and configured to maintain uniform pressure on, and regulate deformation of, the elastomer diaphragm; and a controller configured to operate an electrically powered drive mechanism configured to generate airflow to controllably cause the elastomer diaphragm to retract to draw the medicament into the internal volume of the reservoir assembly, or to stretch to expel the medicament from the internal volume of the reservoir assembly to be injected into the patient; wherein the electrically powered drive mechanism is operable to maintain a constant flow rate of the medicament during injection by effecting consistent velocity of the elastomer diaphragm.
23. The device of claim 22, wherein the electrically powered drive mechanism comprises a diaphragm air pump configured to generate and direct a controlled airflow onto the elastomer diaphragm to alternately draw and expel the medicament.
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24. The device of claim 23, wherein the electrically powered drive mechanism comprises: i) a pressure mode, wherein the airflow applies a pressure to the elastomer diaphragm to stretch the elastomer diaphragm; and ii) a vacuum mode, wherein the airflow applies a vacuum to the elastomer diaphragm to retract the elastomer diaphragm. 2025200064
25. The device of any of claims 23 to 24, wherein the reservoir further comprises a pressure chamber configured to create a controlled environment for regulating deformation of the elastomer diaphragm by the diaphragm air pump.
26. The device of claim 25, wherein the reservoir further comprises an air diffuser diaphragm configured to distribute the controlled airflow evenly across a surface of the elastomer diaphragm.
27. The device of any of claims 22 to 26, further comprising one or more sensors configured to measure a tissue resistance and where the device is configured to adjust a medicament flow rate according to the measured tissue resistance.
28. The device of any of claims 22 to 27, further comprising a needle actuation mechanism comprising a stepper motor operatively coupled to the needle assembly to control the needle movement.
29. The device of claim 28, wherein the needle assembly is resiliently biased towards the retracted position, with the stepper motor enabling controlled retraction and extension of the needle.
30. The device of any of claims 28 to 29, wherein the stepper motor includes one or more precision encoders.
31. The device of any of claims 22 to 30, wherein the controller is configured to adjust the operation of the electrically powered drive mechanism based on user input within predetermined parameters.
32. The device of any of claims 22 to 31, wherein the controller includes one or more indicators to display user interactions and device status.
33. The device of any of claims 22 to 32, wherein the controller is configured to activate the electrically powered drive mechanism only in response to a specific user input for device activation.
34. The device of any of claims 22 to 33, wherein the controller is configured to operate according to one or more predefined user input thresholds.
35. The device of any of claims 22 to 34, wherein the needle assembly incorporates
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a safety lock mechanism to prevent accidental needle exposure during transportation or storage.
36. The device of any of claims 22 to 35, wherein the adhesive layer includes hypoallergenic materials.
37. The device of any of claims 23 to 36, wherein the diaphragm air pump is designed for silent operation. 2025200064
38. The device of any of claims 22 to 37, wherein the reservoir includes volume indicators for visual confirmation of remaining medicament.
39. The device of any of claims 22 to 38, wherein the controller is programmed with one or more customizable delivery profiles.
40. The device of any of claims 22 to 29, wherein the device includes a communication unit configured to wirelessly connect with at least one external device, enabling real-time data transmission and remote management with the external device.
41. The device of any of claims 22 to 40, wherein the disposable module is composed of biodegradable materials.
42. The device of any of claims 22 to 41, wherein the controller is configured to utilize a biometric authentication process to authenticate a user of the device.
43. The device of any of claims 22 to 42, wherein the controller is configured to store historical usage data associated with patient treatment progress.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2025200064A AU2025200064B1 (en) | 2025-01-06 | 2025-01-06 | High-Efficiency Elastomer Diaphragm Fluid Delivery System for Accurate Medication Administration |
| AU2025220798A AU2025220798B2 (en) | 2025-01-06 | 2025-08-21 | Injection assembly for a wearable auto-injector, and wearable auto-injector |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2025200064A AU2025200064B1 (en) | 2025-01-06 | 2025-01-06 | High-Efficiency Elastomer Diaphragm Fluid Delivery System for Accurate Medication Administration |
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| AU2025220798A Division AU2025220798B2 (en) | 2025-01-06 | 2025-08-21 | Injection assembly for a wearable auto-injector, and wearable auto-injector |
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| AU2025200064B1 true AU2025200064B1 (en) | 2025-09-18 |
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| AU2025200064A Active AU2025200064B1 (en) | 2025-01-06 | 2025-01-06 | High-Efficiency Elastomer Diaphragm Fluid Delivery System for Accurate Medication Administration |
| AU2025220798A Active AU2025220798B2 (en) | 2025-01-06 | 2025-08-21 | Injection assembly for a wearable auto-injector, and wearable auto-injector |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2025220798A Active AU2025220798B2 (en) | 2025-01-06 | 2025-08-21 | Injection assembly for a wearable auto-injector, and wearable auto-injector |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4634430A (en) * | 1984-03-07 | 1987-01-06 | Fresenius Ag | Pump arrangement for medical purposes |
| US20040115068A1 (en) * | 2002-09-27 | 2004-06-17 | Steffen Hansen | Membrane pump with stretchable pump membrane |
| US20050069425A1 (en) * | 1999-07-20 | 2005-03-31 | Deka Products Limited Partnership | Tube occluder for occluding collapsible tubes |
| WO2013176770A2 (en) * | 2012-05-24 | 2013-11-28 | Deka Products Limited Partnership | Apparatus for infusing fluid |
| US9079701B2 (en) * | 2012-04-20 | 2015-07-14 | Buerkert Werke Gmbh | Pneumatic dosing unit and pneumatic dosing system |
| KR20160054868A (en) * | 2014-11-07 | 2016-05-17 | 서현배 | Air actuated pump divice for delivering drug and cartridge-way or wristwatch type infusion pump having same |
| US20160317740A1 (en) * | 2015-04-29 | 2016-11-03 | Buerkert Werke Gmbh | Dosing device and method for operating a dosing device |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW279133B (en) * | 1990-12-13 | 1996-06-21 | Elan Med Tech | |
| EP2104525A4 (en) * | 2006-12-29 | 2010-12-29 | Amir Genosar | Hypodermic drug delivery reservoir and apparatus |
-
2025
- 2025-01-06 AU AU2025200064A patent/AU2025200064B1/en active Active
- 2025-08-21 AU AU2025220798A patent/AU2025220798B2/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4634430A (en) * | 1984-03-07 | 1987-01-06 | Fresenius Ag | Pump arrangement for medical purposes |
| US20050069425A1 (en) * | 1999-07-20 | 2005-03-31 | Deka Products Limited Partnership | Tube occluder for occluding collapsible tubes |
| US20040115068A1 (en) * | 2002-09-27 | 2004-06-17 | Steffen Hansen | Membrane pump with stretchable pump membrane |
| US9079701B2 (en) * | 2012-04-20 | 2015-07-14 | Buerkert Werke Gmbh | Pneumatic dosing unit and pneumatic dosing system |
| WO2013176770A2 (en) * | 2012-05-24 | 2013-11-28 | Deka Products Limited Partnership | Apparatus for infusing fluid |
| KR20160054868A (en) * | 2014-11-07 | 2016-05-17 | 서현배 | Air actuated pump divice for delivering drug and cartridge-way or wristwatch type infusion pump having same |
| US20160317740A1 (en) * | 2015-04-29 | 2016-11-03 | Buerkert Werke Gmbh | Dosing device and method for operating a dosing device |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2025220798B2 (en) | 2025-11-06 |
| AU2025220798A1 (en) | 2025-10-02 |
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| NB | Applications allowed - extensions of time section 223(2) |
Free format text: THE TIME IN WHICH TO COMPLY WITH A DIRECTION UNDER REG 3.2A HAS BEEN EXTENDED TO 08 APR 2025 |
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| HB | Alteration of name in register |
Owner name: MINCLE CO PTY LTD Free format text: FORMER NAME(S): MINCLE CO |
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