WO2022187155A1

WO2022187155A1 - Smart delivery or collection system for picc

Info

Publication number: WO2022187155A1
Application number: PCT/US2022/018179
Authority: WO
Inventors: Carlo Ratti
Original assignee: Carlo Ratti
Priority date: 2021-03-01
Filing date: 2022-02-28
Publication date: 2022-09-09

Abstract

A personal wearable drug delivery device comprising: a flexible support to be worn by a user, said support having a releasable connection to enable adjustment of the support; at least one fluid container mounted on said support; a fluid circuit fluidly attached to said at least one container; a delivery tube connected to the container via the circuit; a releasable fluid connector attached to the delivery tube downstream of the at least one container and at least one of the following mounted on said support: a UV light source to prevent bacterial contamination of at least a portion of the circuit, and a reversible peristaltic or other type of pump connected to the fluid circuit for delivery control and metering of a fluid from the container to the delivery tube or from the tube to the container; and an electronic control unit connected to the pump.

Description

SMART DELIVERY OR COLLECTION SYSTEM FOR PICC Cross-reference to Related Application The present application claims priority from U.S. provisional patent application 63/154,907 filed on 01 March 2021, the contents of which are incorporated herein by reference in their entirety. Field of the Invention 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). 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. However, out of hospital applications are still hampered by the following limits of present day PICC systems. Control over drug delivery 1. Impossibility to plan drug delivery over time apart from continuous drip, which is a limitation for drugs that require particular spikes in delivery over time (for instance, 4 cl every four hours instead of continuous infusion); 2. Ability to deliver only one type of drug at the time; and 3. Impossibility to remotely control effective drug delivery. Maintenance & cleaning 1. Risk that the elastomer can get disconnected and stop delivering treatment; 2. Difficulty to monitor line clogging, which is one of the most serious issues affecting PICC lines; 3. High risk of bacterial contamination during the therapy; and 4. Difficulty to clean the internal line, as that requires special flushing with normal saline and/or "locking" with heparin or normal saline when not in use. Ease of Use 1. Need to carry a separate elastomer with drug, which is attached to another part of the body and not comfortable to carry around; 2. Stigma of carrying around medical equipment and showing pipings through the clothes; and 3. Impossibility to operate with just one hand and need for help from another person beyond the patient. As a consequence of what stated above, patients can hardly be independent when undertaking out of hospital therapies of any kind, resulting in high cost for the healthcare system and difficulties in performing daily activities. The system can also be used “in reverse” to collect blood from a patient when similar advantages apply. Summary of the Present Invention From a first aspect, 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. From a second aspect, 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. From a third aspect, 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. Ability to carry and deliver more than one drug, that is to be administered at pre-set and different intervals, through the design of an innovative cylindrical sleeve; this includes the ability to run automatic flushing with normal saline and/or "locking" with heparin or normal saline when not in use; and 3. Transmitting regular information on drug delivery and PICC clogging via a wireless connection, which can be accessed by medical personnel in remote locations. Maintenance & cleaning 1. Cleaning of the PICC to avoid clogging through pre-set flushing with saline solution at regular intervals; 2. Refrigeration of the drugs through phase-changing material located in the cylindrical sleeve, e.g. in a suitable bag or pouch; and 3. The use of a continuously operating UV light as disinfectant of the connector in order to prevent bacterial infection. Ease of use 1. More comfortable storage of drugs while ambulating, through the design of an innovative cylindrical sleeve to be placed on patient’s arm around the PICC; 2. Ability to insert a new refill by patient using just one hand; and 3. Via the sleeve, cumbersome drug bottles can be substituted by bags or pouches containing the drug(s) and attached to the sleeve itself. As a consequence of what stated above, patients will be able to autonomously use and replace fluid reservoirs, hence becoming independent in daily routines. Doctors will be able to supervision the therapy remotely through the hospital web-based monitoring platform. Brief Description of the Drawings 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. Detailed Description of the Invention As shown Fig.1, the innovative delivery system involves four elements, which are represented schematically in the figures. Power & control unit The 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. Furthermore, 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. Smart connectivity In order to effectively and efficiently execute the therapy from remote, the doctor will be equipped with user interface for connection to 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. In addition to the features noted above, 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 wherein any one or more of the containers may be, collapsible, for example in the form of bags or pouches. Such 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. As shown in Figs 2, 3, 4, 5 and 6, 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 secured to a body part such as the upper arm of the user. 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. When ready for operation, collapsible containers, such as bags or pouches may be mounted on the mountings 5. On or more 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. In one aspect, 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. In another aspect, 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. In operation, the whole assembly may be encompassed by an outer sleeve 14 of flexible impermeable material such as neoprene. When the device is being operated in reverse to collect blood samples 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. Alternatively, 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. Procedure of operating the Sleeve-based Smart Delivery System for PICC 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. Once the fluid delivery system is in place, 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. According to a preferred embodiment, 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. Furthermore, a UV light emitter placed next to the connector to the PICC reduces the risk of infections. According to a preferred embodiment, the sleeve uses a strap system to adhere firmly to the patient’s arm. The combination of such sleeve acting to press the bags on the arm and a bandage shown in the drawings adhering to skin to support a connector for the PICC and one or more of the bags, which may, as an alternative, be attached to the sleeve, helps the user to wear the system on his/her own. This is in particular the case where the sleeve and/or the bandage are adjustable along the circumferential direction via straps, arrays of pressure buttons or the like. Furthermore, 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. Optionally, pump(s) are powered by replaceable and/or rechargeable batteries. As an alternative, it is possible that 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.

Claims

Claims 1. A personal wearable drug delivery device comprising: a flexible support to be worn by a user, said support having a releasable connection to enable adjustment of the support; at least one fluid container mounted on said support; a fluid circuit fluidly attached to said at least one container; a delivery tube connected to the container via the circuit; a releasable fluid connector attached to the delivery tube downstream of the at least one container and at least one of the following mounted on said support: i) a UV light source to prevent bacterial contamination of at least a portion of the circuit and ii) a reversible 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 or from the tube to the container; and an electronic control unit connected in data exchange to the pump 2. Device according to claim 1, comprising of 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 wherein said pump is a rechargeable battery driven pump. 3. Device according to claim 2, comprising an antenna connected to the control unit, the control unit being programmed to transfer data generated by the pump via the antenna. 4. Device according to claim 2, further comprising 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. 5. Device according to claim 3, further comprising 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. 6 Device according to claim 1, 2, or 3 wherein at least one container is collapsible. 7. Device according to claim 6, wherein at least two containers are bags or pouches. 8. Device according to claim 1, 2 or 3, wherein said support comprises a flexible sleeve to be worn around a user’s arm and having a releasable connection to adjust the sleeve around the arm, the pump and the at least one container being carried by the sleeve support. 9. Device according to claim 1, 2 or 3, comprising a UV light source to prevent bacterial contamination of at least a portion of the fluid circuit. 10. Device according to claim 1, 2 or 3, further comprising a phase changing device to cool the at least one container. 11. Device according to claim 1, 2 or 3, further comprising a small lab-on-a-chip unit to carry our analysis of patient blood. 12. Control system comprising a server, a first intelligent user interface device connected in data exchange with the server and a device according to claim 1, 2 or 3 connected in data exchange to the server via an 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. 13. Control method of a device according to claim 1, wherein the device comprises at least two fluid containers 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. 14. Control method of a device according to claim 1, comprising the step of activating the pump to extract blood from tubing and contact it with a lab-on-chip to determine the presence of viral or bacterial material or to determine the level of biomarkers and to pass said information to the patient, a health care provider or a health care facility via a microprocessor and antenna.