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WO2025147450A1 - Dispositif implantable à dose réglable utilisant un capteur de pression pour le suivi du déplacement d'un piston - Google Patents

Dispositif implantable à dose réglable utilisant un capteur de pression pour le suivi du déplacement d'un piston Download PDF

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Publication number
WO2025147450A1
WO2025147450A1 PCT/US2024/062372 US2024062372W WO2025147450A1 WO 2025147450 A1 WO2025147450 A1 WO 2025147450A1 US 2024062372 W US2024062372 W US 2024062372W WO 2025147450 A1 WO2025147450 A1 WO 2025147450A1
Authority
WO
WIPO (PCT)
Prior art keywords
aimd
drug
module
chamber
piston
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.)
Pending
Application number
PCT/US2024/062372
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English (en)
Inventor
Raju S. DAVE
Xing Su
Himanshu Verma
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Manta Pharma LLC
Original Assignee
Manta Pharma LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US18/781,451 external-priority patent/US20250144291A1/en
Application filed by Manta Pharma LLC filed Critical Manta Pharma LLC
Publication of WO2025147450A1 publication Critical patent/WO2025147450A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • 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
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • 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
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Definitions

  • Embodiments relate to an implantable device comprising multiple modules, e.g., (1) permeability module, (2) sensor module, (3) drug chamber module, (4) valve module, (5) electronics module, and (6) battery module.
  • modules e.g., (1) permeability module, (2) sensor module, (3) drug chamber module, (4) valve module, (5) electronics module, and (6) battery module.
  • an active implantable medical device comprising: a) a permeability module to allow ingress of a fluid into an osmotic chamber, b) a drug chamber module comprising an osmotic agent chamber, a drug chamber comprising a drug or being provided to receive a drug, a piston sandwiched between the osmotic agent chamber and the drug chamber; and c) a valve module to allow unidirectional flow of the drug from the drug chamber to outside the AIMD through one or more drug outlet orifices present within the AIMD; wherein: (i) the AIMD is electrically powered; (ii) the permeability module allows ingress of a fluid into the osmotic agent chamber to establish an osmotic pressure; and (iii) the valve module is configured to open and close as per a predetermined program set within the AIMD to regulate flow of the drug from the drug chamber.
  • AIMD active implantable medical device
  • the AIMD is tubular such that the AIMD is configured to be implanted subcutaneously in a mammal.
  • the permeability module allows forward osmosis.
  • the permeability module comprises a semi-permeable membrane.
  • the semi-permeable membrane is a flat membrane.
  • the permeability module comprises a hollow fibre.
  • the AIMD allows one or more flow of the drug to outside of the drug chamber.
  • the AIMD further comprises a sensor module comprising one or more sensors.
  • the sensor module is configured to detect change in an osmotic pressure built within the AIMD.
  • a change in osmotic pressure in the osmotic pressure chamber is configured to measure displacement of the pressure.
  • the osmotic pressure measuring at least equal to a predetermined value is configured to push the piston towards the drug chamber.
  • the AIMD further comprises an electronic module.
  • the AIMD further comprises a power module.
  • the power module is configured to provide a power source for operation of the AIMD.
  • the electronic module configured to control opening and closing of the valve module as per a predetermined program set within the AIMD to regulate flow of the drug from the drug chamber.
  • movement of the piston towards the drug chamber compared to its previous position before discharge of the drug from the drug chamber is configured for each repeated flow of the drug from the drug chamber.
  • a successive dose-to-dose drug ejection variation is ⁇ 25% or less by volume. In an embodiment, a successive dose-to-dose drug ejection variation is ⁇ 10% or less by volume.
  • an amount of drug ejected from the AIMD is proportional to the displacement of the piston. In an embodiment, an amount of drug released in a single shot of the AIMD is about equal to a distance travelled by a piston times cross-sectional area of the AIMD.
  • the AIMD allows repeated flow of the drug to outside of the drug chamber.
  • two or more modules of the AIMD form a communication network with each other.
  • the variable dose of the drug outside the device is in accordance with a change in the osmotic pressure of the device.
  • body fluid may enter through the semi-permeable membrane, that may generate osmotic pressure that drives the movement of the piston.
  • the electronic module may regulate the valve to control the drug flow based on inputs from the electronic module.
  • the device may be designed with a structure that facilitates subcutaneous implantation. It continuously releases the drug, while the sensor monitors relevant parameters, for example temperature, conductivity, and displacement.
  • the swellable hydrophilic polymers are present in suitable amounts such that the polymeric swelling agent exhibits controlled swelling and the desired rate of drug delivery is obtained and the polymeric swelling agent does not contribute significantly to increasing the size of the osmotic system.
  • the polymeric swelling agent can comprise one or more of the above swellable hydrophilic polymers. Often, a mixture of two hydrophilic polymers provides the desired controlled swelling.
  • Illustrative cellulose derivatives that may be used as swellable hydrophilic polymers in the polymeric swelling agent of the present invention include hydroxy Cl -4 alkyl celluloses such as hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose and the like.
  • the ingress of fluid builds osmotic pressure within the device.
  • An actuator 216 is configured to open valve (without limitation such as, relief valve) using the push rod 220.
  • Sensor 202 senses the built of osmotic pressure and communicates with electronics 212.
  • Actuator is controlled by electronics 212 of the device.
  • the push of the piston 204 after a definite osmotic pressure has built release the drug outside through the drug outlet 210.
  • Activation of the implantable device to start the operation is either manually or automatically. Manually signifies with user intervention; and automatically signifies without user intervention.
  • a manual process of activation includes a touch sensor and/or a pressure sensor.
  • a rate of osmotic exchange needs to be assessed to determine the rate of pressure change in the osmotic agent chamber during drug delivery based on the permeability of the semi-permeable membrane.
  • the semi-permeable membrane could be either a cation-exchange membranes (CEMs), anion-exchange membranes (AEMs), alkali anion-exchange membranes (AAEMs) and proton-exchange membranes (PEMs).
  • CEMs cation-exchange membranes
  • AEMs anion-exchange membranes
  • AAEMs alkali anion-exchange membranes
  • PEMs proton-exchange membranes
  • the semi-permeable could be non- ionic membrane.
  • the membrane could be synthetic or biological membrane.
  • the membrane 202 is typically stationary and coupled to an osmotic agent chamber.
  • Exemplary materials further include Neosepta type membranes, C/R, CMB, CMB-2, C66-F, and CCG-F, AM-1, AM-3 AFN and AM-X from Ameridia CM-1, CM-2, CMB, and others, commercially available from AMERIDIA, CMI 7000, Membranes International and PC-200D from PCA GmBH; ome typical resins include copolymers of styrene and di-vinyl benzene having sulfonate ion as the charge group, which have a high selectivity for sodium ions.
  • Such commercial cationic membranes e.g., Nafion type membranes, are available from Dupont.
  • the membrane is a substantially flat membrane. Substantially flat signify that the membrane when viewed from a naked eye over a flat surface seems flat.
  • the membrane 302 as shown in Fig. 3 A could be supported by a plate or a support structure 304. However, in some cases, if the membrane 302 has enough strength of its own to remain stationary without the support, then plate 304 may not be necessary in the permeability module. Plate 304 should be either a porous separator that is at least permeable to H2O and NaCl molecules and enables water and ions from an external source e.g., an inside of a living being's body, to migrate into the device. In some cases, plate 304 could have holes to allow fluid inflow inside the device.
  • the membrane 102 (semi-permeable membrane) is sandwiched between two plates such as a front plate and a back plate (not shown in figure). Sandwiched herein signifies two plates are on either side of the membranes, however other materials could be present between plate and the membrane, if needed.
  • front plate and back plate may have a plurality of holes (not shown in Fig. 3A). Alignment of plurality of holes in the front plate and the back plate could help in adjustment of ingress fluid inside the device. For example: if all holes of the front plate and back plate are aligned together, then the flow of the fluid will be maximum, and if none of the holes are aligned then flow of the fluid into the device is completely stopped. This intermediate configuration allows fine tuning of the ingress rate. This adjustment could be adjusted prior to operation of the device.
  • a device having a sensor to monitor the ingress of the fluid and motor to rotate the plates may perform similar tasks inside the body of the user.
  • the permeability module may have hollow fiber or bundles of hollow fibers arranged together, forming a bridge for entry of fluid into the device as shown in FIG. 3B.
  • the permeability module has an exterior surface 306 with plurality of holes 308.
  • the exterior surface 306 is holding one or more bundles of hollow a hollow fiber 310.
  • One or more hollow fibers are made of a semi-permeable membrane and have a hollow core, allowing water to flow through. Both ends of the fibers, on the right side and the left side of the casing are U shaped.
  • the hollow fibers contain a solute solution such as but not limited to glucose solution (G) as shown in FIG. 3B.
  • a solute solution such as but not limited to glucose solution (G) as shown in FIG. 3B.
  • the high concentration of the glucose solution allows natural osmosis to happen within the device.
  • osmosis is the diffusion of a liquid (most often assumed to be water, but it can be any liquid solvent) through a semi-permeable membrane from a region of high chemical potential to a region of low chemical potential.
  • the selectively permeable membrane must be permeable to the solvent, but not to the solute, resulting in a pressure gradient across the membrane.
  • the force per unit area required to prevent the passage of solvent through a selectively permeable membrane and into a solution of greater concentration is equivalent to the turgor pressure.
  • Osmosis can be controlled or modulated in a number of ways, e.g. by increasing the pressure in the section of high solute concentration with respect to that in the low so
  • concentration of an osmotic agent could vary from 0 to 10 millimolar to 20 millimolar to 50 millimolar to 100 millimolar to 150 millimolar to 200 millimolar.
  • the hollow fibers contain solutes such as but not limited to NaCl.
  • the hollow fiber membrane is a forward osmosis membrane and comprises an inlet end facing the first end of the device towards the first end and an outlet facing internal of the device. These membranes utilize the natural osmosis process, where water moves from a low concentration to a high concentration through the membrane. Natural osmosis requires lower energy compared to traditional reverse osmosis systems that operate under lower pressure conditions, within hollow fibers.
  • the implantable device has a sensor module along with other modules, parts and features as described in different embodiments of this disclosure. An example of a sensor module is shown in FIG. 4.
  • a sensor module without limitation includes at least one sensor.
  • biosensor relates to an analytical device, used for the detection of a chemical substance, that combines a biological component with a physicochemical detector.
  • the sensitive biological element e.g., tissue, microorganisms, organelles, cell receptors, enzymes, antibodies, nucleic acids, etc.
  • the biosensor may include without limitation pulse oximeter, heart rate sensor, ECG sensor, skin sensor(s), body temperature sensor, blood pressure sensor, impedance sensor etc. According to one embodiment, all types of biosensors come under the scope of the present invention. The biosensor helps in detecting physiological parameters of the body.
  • an output from these sensors is utilized to provide real-time feedback to a processor.
  • Real-time feedback allows precise delivery of drugs by responding to variations in conductivity level, osmotic pressure, etc., thereby aligning dose discharge as per the patient's need by operating the valves of the device that regulates flow of drug discharge.
  • the conductivity sensor comprises an integrated Resistance Temperature Detector (RTD) sensor (for example, PtlOOO).
  • RTD Resistance Temperature Detector
  • PtlOOO has a base resistance value of 1000 ohms at 0°C. It is suitable for 2-wire circuit configurations, has less significant impact of lead wire resistance, consumes less power due to high resistance, and is typically available only with thin-film element constructions. Temperature often influences the result of a conductivity sensor. Therefore, it is possible that the conductivity sensor has a temperature compensation mechanism to ensure accuracy in the changing environment.
  • FIG. 6B shows position of ON-OFF state of the valve module.
  • the device has a stepper motor.
  • FIG. 6C shows the use of stepper motor and vibratory motor as actuator for actuating a push rod for opening and closing of the relief valve.
  • a stepper motor may work in the following way: connected to a screw via a coupler, responsible for initiating movement.
  • the stepper motor rotates, it turns the screw, driving a nut threaded onto it.
  • This rotation causes the nut to move linearly along the screw, with the direction of movement determined by the motor’s rotation.
  • the nut will attach to a push rod, and as the nut moves, it will push or pull the rod, creating linear motion.
  • This motion will be directly linked to the relief valve, opening or closing it by applying force to the valve's mechanism. Control of this process could be managed by a stepper motor driver, which will receive signals to control the motor's speed, direction, and movement distance.
  • a processor could send signals to the motor drivers, dictating the motor’s operation and, consequently, the position of the push rod and relief valve. For example, when the processor sends a signal to rotate the motor in a specific direction, the nut and push rod will move, opening the relief valve. Conversely, when the motor’s direction is reversed, the nut and push rod will retract, closing the valve. This system will allow for highly accurate regulation of the valve’s opening and closing providing precise control over the flow or pressure of the liquid in the system.
  • a vibratory motor instead of providing rotational motion, generates oscillating vibrations.
  • a vibratory motor would be connected to the screw or another mechanism capable of converting the vibrations into linear motion.
  • the vibratory motor will generate oscillating motion, which is transferred to a push rod via a mechanical linkage, such as an eccentric cam or lever.
  • the vibratory motion causes the push rod connected to a relief valve to move back and forth, thereby opening and closing the valve.
  • the ball like structure 600 acts as a physical barrier to control the drug's movement.
  • the ball like structure 600 allows drug flow only when a force from the direction opposite to the one-way flow of the drug, such as pressure generated by the vibrating plate 604, displaces the ball like structure 600 momentarily, enabling a precise amount of the drug to enter the needle.
  • the vibrating plate 604 Upon actuation, the vibrating plate 604 generates, connected to the plunger needle like structure 602, generates controlled oscillatory motions (vibrations), which are transmitted to the needle like structure 602.
  • An implantable device of the present disclosure has a power supply module along with other modules, parts, and features.
  • the electronic module and/or the power supply module is/are separated from the rest of the modules of the device by a waterproofing (or another liquid tight barrier).
  • a power module of an implantable drug delivery device comprises at least one power source and a power switch.
  • the power source is a rechargeable power storage, harnessing energy from the environment, for example: energy could be harvested by converting kinetic energy of body movements into electrical power, or by utilizing body heat to generate power, or by capturing energy from the heartbeat, or by using the body’s electromagnetic fields.
  • the device receives power through induction charging from an external source.
  • the power source is a coin battery or button battery.
  • Coin battery is a small battery made of a single electrochemical cell and shaped as a squat cylinder typically 5 to 25 mm (0.197 to 0.984 in) in diameter and 1 to 6 mm (0.039 to 0.236 in) high - resembling a button.
  • Coin battery is adapted to achieve a reduced size AIMD.
  • Stainless steel usually forms the bottom body and positive terminal of the cell; insulated from it, the metallic top cap forms the negative terminal.
  • Batteries employed in the power module could be either primary cells or rechargeable secondary cells. It is also possible that device has a combination of primary and rechargeable secondary cells.
  • the motor may be attached to the vibrating plate using several methods. Some of them are 1) Direct Adhesive Attachment, 2) Clamping, 3) Screw mounting, 4) 3D-Printed Motor Holder, 5) Elastic Bands, 6) Foam or Rubber Dampers.
  • the motor may be attached to the vibrating plate using strong adhesives like epoxy glue, hot glue, or double-sided industrial-grade adhesive tape to secure the motor to the underside of the plate. The adhesive are vibration resistant.
  • the motor may be clamped to the vibrating plate using small brackets or clamps. This is useful for removable designs where you might need to replace the motor. If the motor has mounting holes, the screws or bolts may be used to attach it to the plate. Corresponding holes may be drilled in the plate for precise alignment.
  • a custom motor mount may be 3d printed to hold the motor snugly and can be glued or screwed to the plate.
  • the rubber bands or elastic straps used to tightly hold the motor against the plate.
  • the motor may be placed on a thin foam pad or rubber strip before attaching it to the plate to reduce noise and stress on the motor.
  • FIG. 6F illustrates an arrangement of components of a vibrating plate for 5mm device, according to one or more embodiments.
  • the vibrating plate is attached directly to the motor shaft to achieve compact sized AIMD.
  • the motor adapted to actuate the vibrating plate may be a coin motor.
  • the coin motor is compact and fits snugly within the tube of the AIMD (5mm).
  • the button cell battery may be positioned below the motor to power the system.
  • the switch may be a miniature tactile, or reed switch located at the base.
  • the reed switch may be a magnetic sensing component.
  • the reed switch enables the device to respond to external magnetic fields for activation, deactivation, or control of the vibrating plate mechanism.
  • the reed switch is a small, biocompatible, sealed device consisting of two thin ferromagnetic metal reeds inside a glass tube. When exposed to a magnetic field, the reeds come into contact (or separate, depending on the design), completing, or breaking an electrical circuit.
  • the reed switch acts as an on/off switch for the device. By bringing a magnet near the implant, the switch closes or opens the circuit, activating or deactivating the vibrating plate.
  • the implantable device has an electronic module along with other modules, parts and features.
  • An electronic module has chips, electronics housing and/or electronic components.
  • the electronic module of the implantable drug delivery device comprises without limitation one or more sensors, communication system, power switch, data stores that interact to ensure proper functioning. Sensors may continuously or discontinuously monitor various parameters such as drug levels within a patient’s body and/or within the device, patient vitals, and environmental conditions, etc., to provide real-time data to the processor for processing.
  • the power from the power source module is distributed to one or more components of the device such as sensors, piston, valves etc. Distribution of power to various components of the device is controlled by the electronic module.
  • a processor or simple timer of the electronic module manages the device’s operations, including recording and adjusting medication dosing based on sensor inputs, monitoring fault conditions, processing sensor data for accurate operation, and overseeing battery status and power usage. In an embodiment, it may also store relevant patient medical history for reference. The system ensures that the implantable drug delivery device operates efficiently and effectively, providing necessary treatment while maintaining patient safety.
  • FIG. 7 shows power distribution to various components such as a pressure sensor, conductivity sensor to monitor the internal environment of the device and drug levels.
  • the actuator driver uses this power to control the release mechanism, ensuring precise drug delivery.
  • the power switch controls the device’s power state, allowing it to be turned on or off as needed.
  • an electronic signal from the fourth chamber is transmitted to the first chamber, second chamber and/or third chamber via an electric circuit.
  • the electric circuit is printed on the implantable device.
  • the processor of the electronic module is configured to analyze the medical characteristics of the patient to determine a symptom associated with a medical condition such as without limitation measuring physiological parameters of the host of the device.
  • processor is configured to analyze medical characteristic of the patient to determine a symptom associated within the patient, wherein the symptom corresponds to a decrease in respiratory rate, a decrease in heart rate, a decrease in blood pressure, deviations from normal body temperature, passing out or an unresponsive loss of consciousness, skin color changes, abnormal breathing, fast, slow or irregular breathing, severe chest pain, seizures, severe headaches, difficulty in breathing, delirium, agitation, and/or anxiety.
  • the processor is further configured to send an alert or notification wirelessly upon detection of the symptom.
  • the electronic module is also configured to data logging and storage functionalities. This helps to retain important information such as dosing history, sensor readings, fault conditions, and battery status, which are crucial for monitoring and adjusting treatment.
  • an active implantable medical device comprising: a permeability module to allow ingress of a fluid into an osmotic agent chamber of the AIMD, a piston, a drug chamber comprising a drug or being provided to receive a drug and a valve module to allow flow of the drug from the drug chamber to outside the AIMD through one or more drug outlets present in the AIMD, wherein an electrical actuator is configured to control a dose frequency of the drug released from the drug chamber, and wherein the AIMD is an electrically powered device.
  • AIMD is configured to control a dose size of the drug mechanically without an electrical power supply.
  • the volume of the dose size varies by no more than ⁇ 25% from that of a target volume irrespective of a time duration for which a flow discharge valve.
  • the system enables a single operator to look at multiple patients.
  • the Al engine may receive the time series data or real-time data in a multi-dimensional space.
  • the Al engine may receive the time series data in a representation (for example, in a two or three dimensional space).
  • the datasets are read including patient’s data and/or device data.
  • the Al engine learns, in order to detect anomalies, within what range all of these dataset’s span.
  • the sphere is created, which is the boundary for datasets, which could be a sphere.
  • the Al engine also learns, based on the datasets received, what is the shape within which every dataset falls.
  • the Al engine upon learning the multi-dimensional shape of the cluster, determines an anomaly when a dataset goes outside that shape. The shape drawn is then highlighted for anomaly detection.
  • the Al engine learns the boundary and looks for data within that space and/or the boundary. For example, for a specific patient, the shape could be different. For the patient already having a heart issue, the heart will function differently, and datasets will be different.
  • the pretrained Al engine is implemented, the accuracy of the functioning of the Al engine is not optimized, because the Al engine is initially trained on different devices and different patients (similar in nature, but nevertheless not the same patient).
  • the Al engine needs to be retrained and adjusted.
  • the datasets received and the plot made for that specific patient may have a shape that looks slightly different.
  • the shape of the specific cluster in that multidimensional space, might mostly fit inside the space of a healthy patient.
  • the Al engine may be combined with different inputs e.g., inputs from accelerometer sensor, biometric sensors, and voice modules. For example, when the patient falls and they are shouting for help, a voice input from the voice module and sensor inputs, like heart rate from biometric sensors, are read. The different inputs from different axes get correlated by the Al engine and provides training to the Al engine.
  • an Al engine may undergo two types of training.
  • the first is initial training (pre-training), and subsequent (second) re-training to fine tune the Al for the specific device and specific patient.
  • pre-training the Al engine learns to understand the group of the patient.
  • the patient group may be categorized based on demographics.
  • the Al engine is a trained device initially for different categories, for example, kids, men, women, boys, girls, older people, etc.
  • the Al engine undergoes different types of training in particular categories based on the current state, e.g., sleeping, awake, exercising, eating, etc.
  • the Al engine first detects the state.
  • the Al engine comprises a state detection module which detects what state the person is in.
  • the state detection module depending on time of the day and various other metrics, figures out the current state such as sleeping, or awake.
  • the Al engine instructs the implantable device to provide dosage and/or dynamically adjust dosage at appropriate times.
  • the Al engine comprises a group identification module that determines which group or category the patient falls in.
  • the Al engine may also perform lag detection between the data of the device and the patient.
  • the Al engine may also monitor how the patient is performing over a longer period of time.
  • the Al engine is capable of receiving medical conditions from the patient feedback.
  • the Al engine extracts the medical conditions (e.g., a patient’s undergoing medications) from the previous medical records. There might be different medical conditions, and the Al engine learns more about the medical conditions and the corresponding treatments/medications provided. For example, for a heart patient the Al engine defines medical conditions and determines what the cohort for that patient is.
  • the medical conditions e.g., a patient’s undergoing medications
  • the Al engine also gets trained regarding approvals coming from FDA approvals for specific types of patients having specific conditions and the like.
  • the Al engine also learns about the datasets based on which have been trained for those specific conditions.
  • the Al engine also gets trained in other types of medical conditions that have enough patients.
  • the Al engine gets trained in three types: supervised learning, unsupervised learning, deep networks, and large language models.
  • Supervised Learning comprises labelling.
  • supervised learning is a labor intensive, costly process, where one has to go through the data set, start labeling everything coming from it.
  • the data set has to be read and marked as an anomaly or not an anomaly.
  • the supervised learning happens for a longer period of time for a lot of data sets.
  • the Al engine eventually starts learning and figuring out the labeling.
  • the second one is unsupervised learning. Unsupervised Learning is nothing but clustering which is another option.
  • the third option is deep networks.
  • the Al engine starts using deep networks.
  • the fourth one, within that deep network classification coming in is large language models, which are becoming popular, (for example: ChatGPT®).
  • the Al engine uses large language models in detecting background noise.
  • the large language model can understand the voice data from a microphone and transcribe it to understand content and tone of the voice.
  • the model can also detect unusual noise, calls for help, and sense anxiety, stress or distress in the voice of patient.
  • the voice inputs may be received from the microphone.
  • the Large Language Model can classify background noise with voice inputs and start classifying the background noise and extracting the voice inputs.
  • the Al engine after dosing, monitors some other parameters based on recent case studies or recent medical scenarios.
  • the Al engine monitors certain other parameters, which become more important based on the recent medical scenarios.
  • the Al engine keeps monitoring the regulations and/or recent updates in the medical field and may monitor other parameters dynamically after the dosage is done.
  • the Al engine may communicate with medical databases that keeps track of the recent updates in the field.
  • the Al engine may comprise a natural language processing module that interprets the context and provides recommendation to the Al engine.
  • the mapping also might become fairly important for us down the line.
  • the Al engine tracks and updates the mapping dynamically to keep the changes up to date.
  • the Al engine comprises a system that allows the user to plug in any kind of time series dataset, and then start training the Al engine quickly.
  • the Al engine enables any kind of time series data to be fed into the system.
  • the Al engine comprises visual interfaces for various data points.
  • the visual interface is one where the different data points can be plugged in.
  • the visual interface is also adapted to read all of these datasets, and constantly train the Al engine on a large number of patients.
  • the Al engine can then be specifically customized for a specific patient.
  • the Al engine also works and functions when few data points are removed from that patient. For example, the patient has a sensor on their arm, and while sleeping the oxygen sensor falls off in your sleep. The patient may not want an alarm to go off and notify anyone that the oxygen sensor is off.
  • the Al engine works even in such a scenario when some of these time series datasets flatten out.
  • the Al engine also functions and provides anomaly detection and/or dosage adjustment when the device flattens out or certain device sensors stop functioning.
  • the Al engine functions in a manner where even if certain data sets are not available, or if additional data sets are available, the Al can adjust and continue to make decisions. It can replace one parameter with another strongly co-related parameter/time series.
  • the Al engine is able to deal with certain critical scenarios. For example, the Al engine has certain data points constantly when a patient is on a ventilator. But if there are other sensors plugged into the patient, and if you have that data coming in, the Al engine takes in that data as an additional data feed and incorporates it.
  • the Al engine might work under different conditions.
  • the Al engine is enabled to automatically choose the dosage.
  • the Al engine until it leams the dosage, the patient/the caregiver/the doctor, could start off with medications, like antibiotics which have instructions available via an interface.
  • the Al engine also leams that certain antibiotics have stepped dosage requirements based on recent updates in the external medical database through NLP.
  • the Al engine can incrementally increase the dosage and observe if the patient is reacting or not reacting to the dosage.
  • the Al engine may also receive approval by the doctor before stepping up the dosage requirements.
  • FIG. 9 shows an example flow chart for detecting a device anomaly using a machine learning model.
  • the device anomaly may comprise an implant failure and/or side effects associated with the implantable device.
  • the system may receive data associated with one or more sensors 902 from the implantable device. Data pertaining to the performance of the implantable device can be gathered using any type of sensor, for example, pressure measurement, leakage, infrared measures, temperature measures, or any other information measured or detected by sensors.
  • a sensor output may be the result of one or more sensors capturing environmental information associated with the subject having the device implanted.
  • the system may receive other data 906, for example, from wearable devices, external electronic medical record databases, and attachable monitoring devices.
  • the machine learning model 904 of the system can process the data to generate a score representing likelihood of a device anomaly 908. If the score is sufficiently high 910 the system sends an alert and suggests action 912 via a user device.
  • the user device may comprise a mobile phone or a laptop. In some embodiments, the model is already trained.
  • Patient Sensors measure the patient’s vital signs such as body temperature, heart rate, blood pressure, blood glucose level, etc. This time series data will then be sent to the Time Series Data Collection Unit.
  • the mobile app will take input from the patient on a regular basis, including weight, height, medication, schedule, etc. This data will then be sent to the Time Series Data Collection Unit.
  • Time Series Data Collection Unit reads in and stores real-time data, it will clean the data, look for patterns, identify parameters with a strong correlation and eliminate unnecessary parameters, identify time lag between medication and changes in vital signs, and accordingly recommend drug dosage amounts/times/frequency to best suit the patient.
  • the doctor/device specialist will have access to new data on the web user interface regarding the device operation status, reinforcement training, supervised training, and historical data classification.
  • the patient will also be given an external device to place on the skin, which contains a rechargeable battery and will charge the implantable device. It also contains an accelerometer and voice input module to detect if the patient is falling or in pain.
  • a patient attendant will monitor the patient’s vitals and calibrate the sensors if sensor drift is detected.
  • Couple should be broadly understood and refer to connecting two or more elements mechanically and/or otherwise. Two or more electrical elements may be electrically coupled together, but not be mechanically or otherwise coupled together. Coupling may be for any length of time, e.g., permanent or semi-permanent or only for an instant. “Electrical coupling” and the like should be broadly understood and include electrical coupling of all types. The absence of the word “removably,” “removable,” and the like near the word “coupled,” and the like does not mean that the coupling, etc. in question is or is not removable.
  • the invention measures the value of a physiological parameter of a subject (e.g., state of metabolism, state of lowered metabolism, state of rest, etc.), including obtaining the data using sensors attached to the subject.
  • a time-dependent relationship function could be applied on the value of the obtained physiological parameter of the subject at a particular time-of-day using at least one processor to determine a real-time value and/or predict the future physiological parameter of the subject for the given condition.
  • the term “remote device” refers to a device that receives data from a detector component and/or a monitoring system.
  • the remote device may receive data from a sensor.
  • the remote device comprises a processor, memory, and its own communication circuitry and power source to process the data.
  • adjustable threshold(s) refers to a predefined value at which the application can be set to trigger alerts when chemicals are detected in specific concentrations.
  • the implantable device comprises: a casing that is substantially tubular and has at least a first end and a second end opposite to the first end, a semi-permeable membrane plug at or near the first end, a first chamber comprising an osmotic agent, wherein one wall of the first chamber comprises the semi-permeable plug, a second chamber comprising a drug, a third chamber comprising a flow switch and at least one drug delivery orifice, a piston separating the first chamber and the second chamber, a fourth chamber comprising an electronic control unit and a source of energy, wherein an osmotic pressure is configured to be built on ingress of a liquid into the first chamber through the semi-permeable membrane plug that displaces the piston towards the second chamber; and wherein the flow switch and the osmotic pressure together regulate a release of the drug from the at least one drug orifice, such that the flow switch in its ON state allow the drug to be released from the at least one drug orifice and in its OFF
  • the fourth chamber further comprises a piston position determination module.
  • the piston position determination module is configured to determine a real-time positioning of the piston.
  • the piston determination module is based on pressure measurement, conductance measurement, resistance measurement, pressure measurement, reflection measurement, capacitance measurement, impedance measurement, radical measurement, image-based measurement, laser measurement, SONAR based measurement, ultrasound measurement, time of flight measurement or combinations thereof.
  • the piston position determination module interacts with one or more electro-mechanical actuator to control an ingress flow of the liquid inside the implantable device and an egress flow of the drug outside the implantable device.
  • the implantable device further comprises a sensor.
  • the implantable device further comprises one or more biosensors.
  • one or more biosensors is configured to either detect a biomarker present in a human or an animal body, a concentration of the drug release from the implantable device and/or a bio-chemical parameter of the human or an animal body.
  • the biosensor is a wearable device.
  • the semi-permeable plug comprises cellulose acetate.
  • a rate of ingress of the liquid in the implantable is in a range of about 0.5 pl/min to 2 pl/min.
  • the first chamber comprises the pressure sensor and/or the conductivity sensor.
  • an electric circuit connects a sensor and the actuator to electronic control unit in the fourth chamber to control the flow of the drug from the implantable device.
  • An aspect of the disclosure relates to a system comprising a software implemented module and an implantable device comprising: a casing that is substantially tubular and has at least a first end and a second end opposite to the first end, a semi-permeable membrane plug at or near the first end, a first chamber comprising an osmotic agent, wherein one wall of the first chamber comprises the semi-permeable plug, a second chamber comprising a drug, a third chamber comprising a flow switch and at least one drug delivery orifice, a piston separating the first chamber and the second chamber, a fourth chamber comprising an electronic control unit and a source of energy, and one or more sensors to detect amount of the drug released from the implantable device; wherein an osmotic pressure is configured to be built on ingress of a liquid into the first chamber through the semi-permeable membrane plug that displaces the piston towards the second chamber, which further pushes the drug present in the second chamber to be release from the at least one drug orifice, and where
  • An aspect relates to a method comprising: receiving data from one or more sensors present on an implantable device, transmitting the data to one or more software implemented module, analyzing the data and providing an output, wherein the output regulates ingress of a liquid inside the implantable device through a semi-permeable plug present at or near first end, and egress of a drug stored in the implantable device through one or more drug orifices into a body of a human and an animal.
  • the one or more software implemented module comprises at least one of a data collection unit, a data processing unit, a prediction unit, and/or a dosage recommendation unit.
  • the one or more sensors collects data on a biochemical parameter of the body of the human and the animal in which the implantable device is implanted.
  • the data collection unit is configured to collect the data from the one or more sensors and send the data further to the data processing unit.
  • the data processing unit is configured to analyze a physiological condition of the body of the human and the animal in which the implantable device is implanted.
  • the prediction unit is configured to utilize a machine learning algorithm to provide a drug dosing pattern according to the physiological condition of the body of the human and the animal.
  • the method is configured to provide a personalized drug dosing pattern according to a physiological condition of the body of the human and the animal in which the implantable device is implanted.
  • An aspect relates to a system comprising: a body temperature stable drug formulation that ensures that the drug does not degrade within the body of the subject at a body temperature of the subject for at least 6 months; an implantable biosensor that provides real-time monitoring of a drug level and/or a health-related biomarker; and an artificial intelligence system that integrates and analyzes data to optimize drug delivery in real-time; wherein the system is configured to be an AI- based implantable drug delivery system.
  • the subject comprises a human being and the body temperature of the subject is in a range from 95 °F to 105 °F.
  • the disclosure relates to a device comprising a casing comprising: a first module comprising a semi-permeable membrane plug; a second module comprising a pressure sensor; a third module comprising a piston and a drug reservoir chamber; and a fourth module comprising a flow switch and an electronics chamber comprising a power supply component; wherein the device is configured to be implanted subcutaneously by an injector device in a body of a subject via an incision; wherein the device is configured to deliver multiple doses of a drug within the body of the subject with a dose-to-dose variation of ⁇ 25% or less by volume; and wherein the device is configured to notify in case of anomaly in the device.
  • the device is configured to be located in a subcutaneous region within the body of the subject during delivery of the drug into the body of the subject.
  • the device may have a dual piston assembly configuration.
  • the dual piston assembly comprises a first piston from a first end and with a second piston from a second end.
  • both the pistons may be connected by an object such as a string, spring, etc.
  • the disclosure relates to a system comprising a device comprising a casing further comprising a first module comprising a semi -permeable membrane plug, a second module comprising a pressure sensor, a third module comprising a piston and a drug reservoir chamber, and a fourth module comprising a flow switch and an electronics chamber comprising a power supply component; and a catheter-like tube connected to the drug reservoir of the device to deliver a drug anywhere in a body of a subject away from the device; wherein the system is configured to be implanted subcutaneously; wherein the system is configured to deliver multiple doses of the drug within the body of the subject with a dose-to-dose variation of ⁇ 25% or less by volume; and wherein the system is configured to notify in case of anomaly in the device.
  • the catheter-like tube comprises a secure connector at one end for connecting to the device and wherein the secure connector permanently attaches the catheter- like tube to the device making the catheter-like tube and the device integral with one another.
  • the catheter-like tube detachably attached to the device.
  • the catheterlike tube delivers the drug to a target area of interest in the body.
  • the catheter-like tube comprises a flexible loop along a length of the catheter-like tube to minimize a force generated due to detaching or reattaching the catheter-like tube to the device.
  • a drug delivery end of the catheter-like tube comprises one of a "mist" outlet, a "jet” outlet, and a "rectangular opening" outlet.
  • An aspect of the disclosure relates to a system comprising an implantable device and a patch configured to attach over a human body; wherein the implantable device comprises: a) a permeability module comprising a semi-permeable membrane at one of the device; wherein the permeability module inside the human body allows inflow of a fluid from the semi-permeable membrane into an osmotic agent chamber to establish an osmotic pressure; b) the osmotic agent chamber comprising an osmotic solution; c) a sensor module comprising a sensor configured to monitor a physical parameter; d) a drug chamber comprising a drug; e) a piston assembly comprising a spring and at least one pair of pistons, wherein the piston assembly is sandwiched between the osmotic agent chamber and the drug chamber; f) a valve module to allow unidirectional flow of the drug from the drug chamber to outside the device through one or more drug outlet orifices present within the device; and g) an electronic
  • the drug comprises an opioid antagonist.
  • the opioid antagonist may be Naloxone.
  • the patch further comprises a biosensor to sense a biological parameter of the human body.
  • an opioid overdose detected by the biosensor in the human body directs the patch to send the signal to the electronic module of the device to allow discharge of the drug from the implantable device.
  • a wearable device in communication with the patch.
  • the wearable device is configured to send an emergency signal to a predestined location.
  • the emergency signal from the wearable device and the signal from the implantable device happen simultaneously.
  • the implantable device is implanted subcutaneously within the human body.

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Abstract

Un mode de réalisation concerne un dispositif médical implantable actif (AIMD), comprenant : a) un module de perméabilité permettant l'entrée d'un fluide dans une chambre osmotique, b) un module de chambre à médicament comprenant une chambre à agent osmotique, une chambre à médicament contenant un médicament ou étant destinée à recevoir un médicament, un piston pris en sandwich entre la chambre à agent osmotique et la chambre à médicament ; et c) un module de valve permettant un écoulement unidirectionnel du médicament depuis la chambre à médicament et vers l'extérieur de l'AIMD à travers un ou plusieurs orifices de sortie de médicament présents à l'intérieur de l'AIMD, (i) l'AIMD étant alimenté électriquement ; (ii) le module de perméabilité permettant l'entrée d'un fluide dans la chambre à agent osmotique en vue de l'établissement d'une pression osmotique ; et (iii) le module de valve étant conçu pour s'ouvrir et se fermer selon un programme prédéterminé défini au sein de l'AIMD pour réguler l'écoulement du médicament hors de la chambre à médicament.
PCT/US2024/062372 2024-01-02 2024-12-31 Dispositif implantable à dose réglable utilisant un capteur de pression pour le suivi du déplacement d'un piston Pending WO2025147450A1 (fr)

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US202463617054P 2024-01-02 2024-01-02
US202463617057P 2024-01-02 2024-01-02
US63/617,057 2024-01-02
US63/617,054 2024-01-02
US202463617754P 2024-01-04 2024-01-04
US63/617,754 2024-01-04
US202463566519P 2024-03-18 2024-03-18
US63/566,519 2024-03-18
US202463574330P 2024-04-04 2024-04-04
US63/574,330 2024-04-04
US202463661654P 2024-06-19 2024-06-19
US63/661,654 2024-06-19
US18/781,451 US20250144291A1 (en) 2023-07-23 2024-07-23 Artificial intelligence based implantable drug delivery system
US18/781,451 2024-07-23
US202463689805P 2024-09-02 2024-09-02
US63/689,805 2024-09-02
US202463707896P 2024-10-16 2024-10-16
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PCT/US2024/062372 Pending WO2025147450A1 (fr) 2024-01-02 2024-12-31 Dispositif implantable à dose réglable utilisant un capteur de pression pour le suivi du déplacement d'un piston
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