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WO2022187155A1 - Système intelligent de distribution ou de collecte pour cathéter central inséré par voie périphérique (ccip) - Google Patents

Système intelligent de distribution ou de collecte pour cathéter central inséré par voie périphérique (ccip) Download PDF

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Publication number
WO2022187155A1
WO2022187155A1 PCT/US2022/018179 US2022018179W WO2022187155A1 WO 2022187155 A1 WO2022187155 A1 WO 2022187155A1 US 2022018179 W US2022018179 W US 2022018179W WO 2022187155 A1 WO2022187155 A1 WO 2022187155A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
pump
support
fluid
control unit
Prior art date
Application number
PCT/US2022/018179
Other languages
English (en)
Inventor
Carlo Ratti
Original Assignee
Carlo Ratti
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
Application filed by Carlo Ratti filed Critical Carlo Ratti
Publication of WO2022187155A1 publication Critical patent/WO2022187155A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • 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
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • 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
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • 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
    • 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
    • A61M5/16881—Regulating valves

Definitions

  • the present invention relates in general to drug delivery or blood-collection systems for medical use or therapy and more specifically to the device Peripherally Inserted Central Catheter (hereafter referred to as PICC).
  • PICC Peripherally Inserted Central Catheter
  • the present invention further relates to an integrated, unobtrusive and connected system for domestic or other use outside of hospital long term administration of therapeutic substances.
  • Background to the Invention PICC is a standard medical device developed in 1975 by doctor V. L. Hoshal.
  • PICC consists of a central venous catheter with a silicone elastomer attached to it.
  • the device enters the body of a patient through the skin at a peripheral site. Consequently, it extends to the superior vena cava and dwells within the cavoatrial junction for a prolonged amount of time that usually exceeds two weeks.
  • PICC is being deployed for a continuous drug delivery therapy in the following cases: . prolonged antibiotics therapy; . chemotherapy regimen; . parenteral nutrition; and . in general, therapies that should not be delivered at a peripheral site. Since its introduction, PICC has been used primarily in hospital care. In recent years, out of hospital usage of PICC has become increasingly common, for instance when long term drug administration, e.g. while working or travelling is needed.
  • the present invention provides a personal wearable device comprising: at least one fluid container; a fluid circuit fluidly attached to said at least one container; a delivery tube connected to the container via the circuit; and a releasable fluid connector attached to the delivery tube downstream of the containers and at least one of the following: i) a UV light source to prevent bacterial contamination of at least a portion of the circuit; ii) a flexible sleeve support to be worn by a user, for example around a user’s arm and having a releasable connection to adjust the sleeve around the arm; and iii) a peristaltic or other type of pump connected to the fluid circuit for delivery control and metering of a bio-compatible fluid from the container to the delivery tube; and an electronic control unit connected in data exchange to the pump.
  • a UV light source to prevent bacterial contamination of at least a portion of the circuit
  • a flexible sleeve support to be worn by a user, for example around a user’s
  • the invention provides a control system comprising a server, a first intelligent user interface device connected in data exchange with the server and a device as described above with an antenna connected to the control unit the device being connected in data exchange to the server via the antenna, the server, the intelligent user interface device and the control unit being programmed to be capable of showing on the intelligent user interface, data from the pressure sensor so that a patient’s condition and/or the drug delivery can be remotely monitored.
  • the invention provides a control method of a device as described above, wherein the device comprises a further fluid container and comprising the step of activating the pump to extract saline solution from one of the containers based on a signal from the pressure sensor in order to keep the circuit free of clogs.
  • the present invention permits the transformation of PICC into an effective device for multiple IV drug delivery out of hospital.
  • Advantages of the invention are as follows: Control over drug delivery 1. Precise drug delivery over time through drug pulsing, allowed through a reversible peristaltic or other type of reverse pump. The reverse pump will also allow the extraction of blood samples that could be analyzed locally or collected and shipped elsewhere for further analysis; 2.
  • Fig.1 is a schematic representation of a combination of a power and control unit, a fluids delivery unit with safety management and smart connectivity according to the invention.
  • Fig.2 depicts a sleeve support showing the location of support members enabling other components of the system to be attached to it.
  • Fig.3 depicts the sleeve support with components of the system attached to it.
  • Fig.4 is an exploded view of a device according to the invention.
  • Fig.5 shows the device in a partially assembled condition.
  • Fig.6 shows an assembled device according to the invention.
  • Power & control unit comprehends a specifically manufactured electronic control unit or board, that is equipped with a Wi-Fi connectivity module. Furthermore, the unit accommodates for a rechargeable battery. The battery powers the motors, the pressure sensor to monitor line clogging, the UV light, the controller and the Wi-Fi module.
  • Fluids delivery The process of continuous administration of a substance is controlled and monitored via the control unit.
  • a bag containing a specific fluid is connected to peristaltic pump that releases a medication at precise intervals and flux frequency. What stated above recurs three times, where two fluid bags or pouches contain the medication and the saline solution is located within the third bag or pouch.
  • Safety management In order to prevent the delivery system from sending clogs to the vena cava (with potentially negative consequences for the patient), a pressure sensor is installed before the PICC line.
  • a UV light e.g. a LED UV light, help disinfect the connection between the PICC and the bags and hence reduce the risk of bacterial contamination.
  • the doctor will be equipped with user interface for connection to a web platform.
  • a web platform Through the platform access via the interface e.g. a PC or a tablet or a mobile phone or the like, the doctor will be able to start, monitor and interrupt the administration of substances. Similarly, the patient will be able to get information about the therapy via a personal app loaded in a memory of a PC or a tablet of a mobile phone or the like.
  • devices according to the invention may usefully include one or more of the following features, which can be utilized by themselves or in combination with any one or more of these features:
  • Two or more containers wherein at least one is for containing a medicament and at least one for containing a saline solution that can be used to clean the device and prevent clogging
  • any one or more of the containers may be, collapsible, for example in the form of bags or pouches.
  • collapsible containers may be particularly useful when the device comprises a flexible sleeve support;
  • a battery-driven pump carried by a support, such as a sleeve support as described above, to control delivery and metering of a bio-compatible fluid from the containers to the delivery tube; and an electronic control unit connected in data exchange to the pump, preferably with an antenna connected to the control unit, the control unit being programmed to transfer data generated by the pump via the antenna;
  • a phase-changing device to cool the first and second container for example effecting cooling by absorbing heat as a result of change of state of a solid into a liquid.
  • Suitable phase change materials for use include those used in domestic coolers such organic PCMs such as paraffins having from 14 to 19 carbon atoms and glycerin and inorganic PCMs such as a sodium chloride/sodium sulfate mixture; and A pressure sensor configured to sense the pressure of the delivery tube and wherein the control unit is connected in data exchange to the pressure sensor to enable control of the flow of medicament through the delivery tube.
  • organic PCMs such as paraffins having from 14 to 19 carbon atoms and glycerin
  • inorganic PCMs such as a sodium chloride/sodium sulfate mixture
  • a pressure sensor configured to sense the pressure of the delivery tube and wherein the control unit is connected in data exchange to the pressure sensor to enable control of the flow of medicament through the delivery tube.
  • multiple components of a system may be mounted on a flexible sleeve support.
  • Such sleeve may comprise a sterile bandage 1 provided with one or more hook and loop strips 2 to enable the support to be
  • the support also includes a battery connector 3 which can in use be covered by a connector cover 4, that can for example be in the form of a clear skin bandage and mountings 5 on which one or more containers of saline 6 and container of medicament 7 can be mounted.
  • a battery connector 3 which can in use be covered by a connector cover 4, that can for example be in the form of a clear skin bandage and mountings 5 on which one or more containers of saline 6 and container of medicament 7 can be mounted.
  • collapsible containers such as bags or pouches may be mounted on the mountings 5.
  • rechargeable batteries 8 such as lithium polymer batteries may be mounted on the support and electrically connected to the battery connector 3.
  • the battery or batteries 8 are also connected to a micro-controller 9, one or more peristaltic pumps 10 and a UV light 11.
  • the peristaltic or other type of pumps are configured to pump medicament or saline from the containers 6 and 7 to piping 12 that can, when the device is in use for administering a medication, be connected to a catheter (not shown) for infusing medicament into a patient.
  • the same pump can also be operated in reverse, in order to extract blood samples.
  • a pressure sensor 13 may monitor pressure in the tubing and supply this information to the microcontroller 9, such as a printed circuit board, that may be connected to an antenna 15 for Wi-Fi communication, for example with a hospital web platform or the patient’s or a health care provider’s personal app.
  • the whole assembly may be encompassed by an outer sleeve 14 of flexible impermeable material such as neoprene.
  • a lab-on-chip may be incorporated to obtain real-time blood analysis and relay the results to the patient, a health care provider or a hospital platform through the microprocessor and antenna.
  • the lab-on chip will typically be located close to the pump to take readings on blood passing through the tubing to one or more of the containers.
  • a lab-on-chip may be located in one or more of the containers.
  • Such lab-on-chips may be used to detect viral and bacterial materials in the blood as well as providing information on biomarkers such as glucose levels.
  • the patient installs the fluids delivery sleeve at a convenient location, for example on top of his arm, which has been prepared by a pharmacy according to the prescribed therapy.
  • the sleeve is equipped with a connector which links to the PICC.
  • the personal application and the web platform of health care provider such as a hospital, will send an input to the power and control unit so to start the therapy.
  • the frequency of substance administration can be customized for each patient.
  • medication is alternated with saline solution in order to avoid clogging of the PICC.
  • the therapy begins and the user performs the daily activities. While operating, the pressure sensor in the safety management block assures that there are no clogs.
  • the sleeve uses a strap system to adhere firmly to the patient’s arm.
  • a user interface to monitor and control the pump(s), the UV- light and the sensor(s) via the web is a personal portable intelligent device such as a smartphone, so as that also controlling and/or monitoring can be performed by a single hand.
  • pump(s) are powered by replaceable and/or rechargeable batteries.
  • a single pump is provided and the bio-compatible fluids, e.g. drugs and saline solution, from the bags are extracted via suitable valves controlled by the control unit. Via the peristaltic or other type of pump(s) metering/dosing of the bio- compatible fluids is obtained in order to ensure that the preferred quantity is delivered to the patient.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'administration de médicament portable personnel comprenant : un support souple destiné à être porté par un utilisateur, ledit support présentant une liaison libérable pour permettre le réglage du support ; au moins un récipient de fluide monté sur ledit support ; un circuit de fluide fixé de manière fluidique audit au moins un récipient ; un tube de distribution relié au récipient par l'intermédiaire du circuit ; un raccord de fluide libérable fixé au tube de distribution en aval du ou des récipients et au moins l'un des éléments suivants montés sur ledit support : une source de lumière UV pour empêcher la contamination bactérienne d'au moins une partie du circuit, et une pompe péristaltique réversible ou un autre type de pompe reliée au circuit de fluide pour la commande de distribution et le dosage d'un fluide du récipient au tube de distribution ou du tube au récipient ; et une unité de commande électronique connectée à la pompe.
PCT/US2022/018179 2021-03-01 2022-02-28 Système intelligent de distribution ou de collecte pour cathéter central inséré par voie périphérique (ccip) WO2022187155A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163154907P 2021-03-01 2021-03-01
US63/154,907 2021-03-01

Publications (1)

Publication Number Publication Date
WO2022187155A1 true WO2022187155A1 (fr) 2022-09-09

Family

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Application Number Title Priority Date Filing Date
PCT/US2022/018179 WO2022187155A1 (fr) 2021-03-01 2022-02-28 Système intelligent de distribution ou de collecte pour cathéter central inséré par voie périphérique (ccip)

Country Status (1)

Country Link
WO (1) WO2022187155A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120245565A1 (en) * 2011-03-21 2012-09-27 Pharmaco-Kinesis Corporation Method for delivering gene and cell therapy to a tumor or targeted site using an implanted metronomic biofeedback pump
US20150157788A1 (en) * 2012-08-20 2015-06-11 Roche Diagnostics Operations, Inc. Therapeutic System with an Adaptor for An Infusion Set
US20160199576A1 (en) * 2013-09-03 2016-07-14 Jacqueline Sarah Savage Wearable intravenous fluid delivery system
US20170173261A1 (en) * 2015-11-24 2017-06-22 Jason O'Connor Wearable automated medication delivery system
US20180207368A1 (en) * 2014-07-15 2018-07-26 Ron Nagar Devices, systems and methods for controlling conditions and delivery of substances
US20190134295A1 (en) * 2017-11-06 2019-05-09 Sorrel Medical Ltd Local disinfection for prefilled drug delivery system
US20190282751A1 (en) * 2016-11-28 2019-09-19 Simona DELLA BIDIA Articular administration device
US20200261648A1 (en) * 2017-11-06 2020-08-20 Amgen Inc. Drug delivery device with placement and flow sensing
US20200316291A1 (en) * 2016-04-08 2020-10-08 Amgen Inc. Drug delivery device, method of manufacture, and method of use
US20200338264A1 (en) * 2016-09-23 2020-10-29 Insulet Corporation Fluid delivery device with sensor

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120245565A1 (en) * 2011-03-21 2012-09-27 Pharmaco-Kinesis Corporation Method for delivering gene and cell therapy to a tumor or targeted site using an implanted metronomic biofeedback pump
US20150157788A1 (en) * 2012-08-20 2015-06-11 Roche Diagnostics Operations, Inc. Therapeutic System with an Adaptor for An Infusion Set
US20160199576A1 (en) * 2013-09-03 2016-07-14 Jacqueline Sarah Savage Wearable intravenous fluid delivery system
US20180207368A1 (en) * 2014-07-15 2018-07-26 Ron Nagar Devices, systems and methods for controlling conditions and delivery of substances
US20170173261A1 (en) * 2015-11-24 2017-06-22 Jason O'Connor Wearable automated medication delivery system
US20200316291A1 (en) * 2016-04-08 2020-10-08 Amgen Inc. Drug delivery device, method of manufacture, and method of use
US20200338264A1 (en) * 2016-09-23 2020-10-29 Insulet Corporation Fluid delivery device with sensor
US20190282751A1 (en) * 2016-11-28 2019-09-19 Simona DELLA BIDIA Articular administration device
US20190134295A1 (en) * 2017-11-06 2019-05-09 Sorrel Medical Ltd Local disinfection for prefilled drug delivery system
US20200261648A1 (en) * 2017-11-06 2020-08-20 Amgen Inc. Drug delivery device with placement and flow sensing

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