IL322787A - Blood draw device - Google Patents

Blood draw device

Info

Publication number
IL322787A
IL322787A IL322787A IL32278725A IL322787A IL 322787 A IL322787 A IL 322787A IL 322787 A IL322787 A IL 322787A IL 32278725 A IL32278725 A IL 32278725A IL 322787 A IL322787 A IL 322787A
Authority
IL
Israel
Prior art keywords
lumen
catheter
liquid
pump
distal end
Prior art date
Application number
IL322787A
Other languages
Hebrew (he)
Inventor
Moshe Ashkenazi
Michal Singer
Original Assignee
Sheba Impact Ltd
Moshe Ashkenazi
Michal Singer
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 Sheba Impact Ltd, Moshe Ashkenazi, Michal Singer filed Critical Sheba Impact Ltd
Publication of IL322787A publication Critical patent/IL322787A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150175Adjustment of penetration depth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229Pumps for assisting the blood sampling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150946Means for varying, regulating, indicating or limiting the speed or time of blood collection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/155Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/157Devices characterised by integrated means for measuring characteristics of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • A61L2/10Ultraviolet radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2065Tracking using image or pattern recognition
    • A61L2103/15
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/14Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Robotics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

BLOOD DRAW DEVICE TECHNICAL FIELD id="p-1" id="p-1"
[0001]The present disclosure relates substantially to the field of intravenous catheters, and in particular to a blood draw device.
BACKGROUND id="p-2" id="p-2"
[0002]Central venous access devices (CVADs) are (intravenous) IV catheters that are inserted into the body through a vein (subclavian, jugular or peripheral) that terminates in the superior Vena Cava just above the right atrium. CVADs are an essential part of safe practices in medicine, especially in oncology and critical care, which enable effective venous access and help in avoiding repeated venipunctures. Furthermore, it enables rapid and large amounts IV administration of fluids or medicines (e.g., chemotherapy) to be infused without damaging the vein walls. The use of CVAD for oncology patients or any other patients (chronic or acute) undergoing treatment is common and universal and can be used for long-term access. The use of CVADs is a common practice in ambulatory settings as well. id="p-3" id="p-3"
[0003]Central venous access is a commonly performed procedure, with approximately percent of hospitalized patients requiring central venous access. More than five million central venous catheters are inserted in the United States each year, whereas peripherally inserted central catheter (PICC) line insertion alone is more than 2.7 million annually. id="p-4" id="p-4"
[0004]Drawing blood via CVAD currently may be performed only manually by RNs or physicians trained in central line blood draw. These procedures include flushing the CVAD with 0.9% sodium chloride and Heparinized saline after blood withdrawal to prevent coagulation and thrombosis. These procedures are done using sterile techniques in order to prevent potential complications of infection, such as infections. id="p-5" id="p-5"
[0005]A typical procedure is as follows:a. Collecting the patient's identification and preparing test tubes, Saline, and Heparin;b. Cleaning the injection cap with antiseptic (30 seconds of cleaning, followed by seconds of drying);c. Flushing the line with 10ml Saline (about 1 ml/press, in a start/stop technique); d. Drawing 5 ml blood;e. Connecting each test tube and filling each of them with the correct amount of blood;f. Mixing the tubes;g. Flushing the line with 10ml Saline (about 1 ml/press, in a start/stop technique);h. Flushing the line with 5ml Heparin; andi. Closing the injection cap. id="p-6" id="p-6"
[0006]Numerous complications are associated with CVAD, the most common (in relationto PICC lines) being detailed in Table 1: Table 1Pediatric AdultCLABSI 8.6% 2.1%Thrombosis 2.1% 0.7%Occlu sion/B lockage 8.2% 8.2%Breakage/Rupture 3.9% 2.6%Local Infection 4.5% 3.6% id="p-7" id="p-7"
[0007]Central line-associated bloodstream infections (CLABSIs) are associated with a high-cost burden, costing tens of thousands of dollars. Most cases are preventable with proper aseptic techniques, surveillance and management strategies. Ruptures shorten the life of the CVAD, and might be caused by inappropriate pressure, generated by human hands.
SUMMARY id="p-8" id="p-8"
[0008]Accordingly, it is a principal object of the present invention to overcome at least some of the disadvantages of prior art blood draw devices. This is provided in one example by device for drawing blood from an IV catheter, the device comprising: an actuator; at least one pump; and a control unit. id="p-9" id="p-9"
[0009]In some examples, the control unit is configured, in a drawing stage, to control the actuator to provide a respective fluid path between a distal end of an IV catheter and at least one blood collection tube. id="p-10" id="p-10"
[0010]In some examples, the control unit is configured, in a first flushing stage, subsequent to the drawing stage, control the actuator to provide a respective fluid path between the distal end of the IV catheter and a first liquid reservoir, and control the at least one pump to pump a predetermined volume of first liquid from the first liquid reservoir into the IV catheter. id="p-11" id="p-11"
[0011]In some examples, the control unit is configured, in a second liquid flushing stage, subsequent to the first liquid flushing stage, to control the actuator to provide a respective fluid path between the distal end of the IV catheter and a second liquid reservoir, and control the at least one pump to pump a predetermined volume of second liquid from the second liquid reservoir into the IV catheter. id="p-12" id="p-12"
[0012]Additional features and advantages of the invention will become apparent from the following drawings and description. id="p-13" id="p-13"
[0013]Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise. As utilized herein, "and/or" means any one or more of the items in the list joined by "and/or". As an example, "x and/or y" means any element of the three-element set {(x), (y), (x, y)}. In other words, "x and/or y" means "x, y or both of x and y". As another example, "x, y, and/or z" means any element of the seven-element set {(x), (y), (z), (x, y), (x, z), (y, z), (x, y, z)}. id="p-14" id="p-14"
[0014]Further, unless expressly stated to the contrary, "or" refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by anyone of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). id="p-15" id="p-15"
[0015]In addition, use of the "a" or "an" are employed to describe elements and components of embodiments of the instant inventive concepts. This is done merely for convenience and to give a general sense of the inventive concepts, and "a" and "an" are intended to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise. id="p-16" id="p-16"
[0016]As used herein, the term "about", when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of +/-10%, more preferably 47-5%, even more preferably +/-!%, and still more preferably +/-0.1% from the specified value, as such variations are appropriate to perform the disclosed devices and/or methods. id="p-17" id="p-17"
[0017]The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, but not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other advantages or improvements.
BRIEF DESCRIPTION OF DRAWINGS id="p-18" id="p-18"
[0018]For a better understanding of the invention and to show how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings in which like numerals designate corresponding sections or elements throughout. id="p-19" id="p-19"
[0019]With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how several forms of the invention may be embodied in practice. In the accompanying drawings: id="p-20" id="p-20"
[0020]FIG. 1A illustrates a high-level perspective view of a device for drawing blood, in accordance with some examples of the disclosure; id="p-21" id="p-21"
[0021]FIG. IB illustrates a high-level illustration of various portions of the device of FIG. 1A, in accordance with some examples of the disclosure; id="p-22" id="p-22"
[0022] FIGs. 2A - 2D illustrate various high-level illustrations of a disinfection mechanismfor the device of FIG. I A, in accordance with some examples of the disclosure; id="p-23" id="p-23"
[0023]FIGs. 3A - 3C illustrate various high-level illustrations of various portion of the device of FIG. 1A, including a multi-channel unit, in accordance with some examples of the disclosure; and id="p-24" id="p-24"
[0024]FIGs. 4A - 4D illustrate various high-level illustrations of an exemplary implementation of the device of FIG. 1A, in accordance with some examples of the disclosure.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS id="p-25" id="p-25"
[0025]In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure. In the figures, like reference numerals refer to like parts throughout. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component. id="p-26" id="p-26"
[0026]FIG. 1A illustrates a high-level perspective view of a device 10 for drawing blood. In some examples, device 10 for drawing blood comprises: a housing 20; and an enclosure situated within housing 20 and exhibiting an opening 35. In some examples, opening 35 is shaped and dimensioned such that an IV catheter can be placed within enclosure 30 via opening 35. Although device 10 is described herein as comprising an enclosure, this is not meant to be limiting in any way, and device 10 may exhibit an open-shaped structure, without exceeding the scope of the disclosure. In some examples, device 10 comprises a power source 32. id="p-27" id="p-27"
[0027]FIG. IB illustrates a high-level schematic diagram of a more detailed example of device 10 (housing 20 not shown for simplicity). In some examples, as illustrated in FIG. IB, device 10 for drawing blood comprises: a disinfection mechanism 40; a robotic arm 50; a control unit 60; a memory 70; and one or more catheter sensors 80. In some examples, control unit 60 comprises one or more processors and/or one or more circuits (e.g., integrated circuits and/or FPGAs). In some examples, memory 70 has stored therein sets of instructions that when read by one or more processors of control unit 60 cause control unit 60 to perform various functions, as will be described below. id="p-28" id="p-28"
[0028]In some examples, as will be described below, disinfection mechanism 40 and robotic arm 50 are not provided. id="p-29" id="p-29"
[0029]In some examples, robotic arm 50 comprises a securing mechanism 51 extending therefrom. In some examples, securing mechanism 51 is implemented as a robotic gripper. In some examples, securing mechanism 51 is situated within enclosure 30. id="p-30" id="p-30"
[0030]In some examples, sensor/s 80 comprise one or more cameras. In some examples, the field of view (FOV) of the camera encompasses the entirety of, or most of, the area of the floor 31 of enclosure 30. In some examples, sensor/s 80 comprise one or more pressure sensors positioned on, or within, floor 31 of enclosure 30. In some examples, sensor/s 80 comprise one or more force sensors positioned on, or within, floor 31 of enclosure 30. id="p-31" id="p-31"
[0031]In some examples, responsive to an output of sensor/s 80, control unit 60 identifies the position a catheter within enclosure 30. In some examples, where sensor/s 80 comprise one or more cameras, control unit 60 analyzes the output pictures of the one or more cameras to identify the location of the catheter. For examples, utilizing predetermined image processing techniques, control unit 60 can identify an object placed on floor 31. In some examples, control unit 60 further analyzes the picture/s to differentiate between an IV catheter and a connector of the IV catheter. In some examples, this is performed by identifying a difference in the diameter of different portions of the detected object. In some examples, the connector of the IV catheter is identified in accordance with the diameter thereof, without identifying the lumen. id="p-32" id="p-32"
[0032]In some examples, where sensor/s 80 comprise one or more pressure sensors or force sensors, control unit 60 analyzes the force and/or pressure values applied to floor 31 to identify an object resting thereon. In some examples, control unit 60 further analyzes the force/pressure values to differentiate between an IV catheter and a connector of the IV catheter. In some examples, this is performed by identifying a difference in the weight of the different portion of the catheter. In some examples, the connector of the IV catheter is identified in accordance with the weight, without identifying the lumen. id="p-33" id="p-33"
[0033]In some examples, control unit 60 controls robotic arm 50 to advance towards the identified position of the connector of the IV catheter and controls securing mechanism 51 to secure the connector of the IV catheter, such as by gripping the connector. id="p-34" id="p-34"
[0034]In some examples, device 10 for drawing blood comprises a disinfection mechanism 40, at least a portion of which is situated within enclosure 30. In some examples, as illustrated in FIG. 2A, disinfection mechanism 40 is implemented as a disinfection mechanism 40A. Particularly, FIG. 2A illustrates a high-level schematic diagram of disinfection mechanism 40A. For simplicity, other parts of device 10 are not shown. id="p-35" id="p-35"
[0035]In some examples, disinfection mechanism 40A comprises an ultraviolet (UV) light source 90. In some examples, UV light source 90 is powered by power source 32. In some examples, UV light source 90 comprises a dedicated power source. In some examples, UV light source 90 is a UV-C light source. In some examples, UV light source 90 outputs light exhibiting a peak wavelength in the range of 100 - 280 nm. In some examples, UV light source outputs light exhibiting a peak wavelength in the range of 250 - 280 nm. In some examples, UV light source 90 comprises an LED light source. id="p-36" id="p-36"
[0036]In operation, control unit 60 controls UV light source 90 to emit UV light for a predetermined time period. In some examples, the UV light is emitted during the whole blood draw procedure described below. Alternatively, control unit 60 shuts off UV light source after the predetermined time period. id="p-37" id="p-37"
[0037]In some examples, as illustrated in FIG. 2B, disinfection mechanism 40 is implemented as a disinfection mechanism 40B. Particularly, FIG. 2B illustrates a high-level schematic diagram of disinfection mechanism 40B. For simplicity, other parts of device 10 are not shown. id="p-38" id="p-38"
[0038]In some examples, disinfection mechanism 40B comprises: a reservoir 1comprising antiseptic liquid 105, such as 70% alcohol; and a spray mechanism 110, such as a spray gun. In some examples, spray mechanism 110 comprises an atomizer configured to atomize the antiseptic liquid 105. In operation, control unit 60 controls spray mechanism 1to spray the connector of the IV catheter with a predetermined amount of antiseptic liquid 105. In some examples, control unit 60 controls robotic arm 50 to move the connector of the IV catheter towards spray mechanism 110 in order to spray the connector with antiseptic liquid 105. Alternatively, robotic arm 50 (or a separate robotic arm) moves spray mechanism 1towards the connector of the IV catheter in order to spray the connector with antiseptic liquid 105. In some examples, after spraying the connector with antiseptic liquid 105, control unit 60 waits a predetermined waiting period before continuing. In some examples, the predetermined waiting period is about 15 seconds. id="p-39" id="p-39"
[0039]In some examples, as illustrated in FIG. 2C, disinfection mechanism 40 is implemented as a disinfection mechanism 40C. Particularly, FIG. 2C illustrates a high-level schematic diagram of disinfection mechanism 40C. For simplicity, other parts of device 10 are not shown. id="p-40" id="p-40"
[0040]In some examples, disinfection mechanism 40C comprises: a wiping mechanism 120, such as a rotating mechanism and/or a robotic arm; and one or more pieces of material 130 soaked in antiseptic liquid 105. In some examples, control unit 60 controls wiping mechanism 120 to wipe the connector of the IV catheter with material 130 soaked with antiseptic liquid 105 in a predetermined pattern. In some examples, after wiping the connector with antiseptic liquid 105, control unit 60 waits a predetermined waiting period before continuing. In some examples, the predetermined waiting period is about 15 seconds. id="p-41" id="p-41"
[0041]In some examples, as illustrated in FIG. 2D, disinfection mechanism 40 is implemented as a disinfection mechanism 40D. Particularly, FIG. 2D illustrates a high-level schematic diagram of disinfection mechanism 40D. For simplicity, other parts of device 10 are not shown. id="p-42" id="p-42"
[0042]In some examples, disinfection mechanism 40D comprises a reservoir 1comprising antiseptic liquid 105. In some examples, control unit 60 controls robotic arm 50 to dip the connector of the IV catheter into antiseptic liquid 105 for a predetermined time period. In some examples, after dipping the connector in antiseptic liquid 105, control unit 60 waits a predetermined waiting period before continuing. In some examples, the predetermined waiting period is about 15 seconds. id="p-43" id="p-43"
[0043]In some examples, disinfection mechanism 40 and/or robotic arm 50 are not provided. In some examples, an IV catheter is manually disinfected and connected to device for drawing blood. id="p-44" id="p-44"
[0044]In some examples, as illustrated in FIG. 3A, device 10 for drawing blood comprises a multi-channel unit 140. Particularly, FIG. 3A illustrates a high-level schematic diagram of multi-channel unit 140. For simplicity, other portions of device 10 are not shown. id="p-45" id="p-45"
[0045]In some examples, multi-channel unit 140 comprises: a connection lumen 1extending from a proximal end 151 to a distal end 152; a blood lumen 160 extending from a proximal end 161 to a distal end 162; a heparin lumen 170 extending from a proximal end 1to a distal end 172; a saline lumen 180 extending from a proximal end 181 to a distal end 182; and a pump lumen 190 extending from a proximal end 191 to a distal end 192. id="p-46" id="p-46"
[0046]In some examples, proximal end 161 of blood lumen 160, proximal end 171 of heparin lumen 170, proximal end 181 of saline lumen 180 and proximal end 191 of pump lumen 190 each extend from distal end 152 of connection lumen 150. Thus, fluid flowing through each of lumens 160, 170, 180 and 190 can flow through lumen 150. In some examples, lumens 150, 160, 170, 180 and 190 form a quadruple Y-connector. id="p-47" id="p-47"
[0047]In some examples, an actuator 195 is provided. In some examples, actuator 1comprises a plurality of fluid path controllers 200. In some examples, each of the plurality of fluid path controllers 200 comprises a clamp or a valve. id="p-48" id="p-48"
[0048]In some examples, each of lumens 150, 160, 170 and 180 has associated therewith a respective fluid path controller 200. In some examples, where each fluid path controller 2comprises a clamp, each clamp 200 is secured to a respective one of lumens 150, 160, 170 and 180, and configured to alternately clamp and unclamp the respective lumen. In a clamped state, fluid cannot flow through the respective lumen. In an unclamped state, fluid can flow through the respective lumen. In some examples, clamps 200 are controlled by control unit 60. id="p-49" id="p-49"
[0049]In some examples (not shown), where each fluid path controller 200 comprises a valve, each valve 200 is secured within a respective one of lumens 150, 160, 170 and 180, and configured to alternately open and close the respective lumen. In a closed state, fluid cannot flow through the respective lumen. In an open state, fluid can flow through the respective lumen. In some examples, valves 200 are controlled by control unit 60. id="p-50" id="p-50"
[0050]In some examples, proximal end 151 of lumen 150 is configured to be detachably coupled to the connector at a distal end 311 of the IV catheter 310, lumen 160 is configured to be detachably coupled to a variety of blood collection tubes, lumen 170 is configured to be coupled to a respective reservoir comprising heparin and lumen 180 is configured to be coupled to a respective reservoir comprising a saline solution. id="p-51" id="p-51"
[0051]In some examples, control unit 60 controls securing mechanism 51 of robotic arm to secure distal end 311 of IV catheter 310 to proximal end 151 of lumen 150. id="p-52" id="p-52"
[0052]In some examples, lumen 190 is configured to be coupled to a pumping device, as will be described below. Although device 10 for drawing blood is described herein as comprising a multi-channel unit 140, optionally implemented as a quadruple Y-connector, this is not meant to be limiting in way. In some examples, as will be described below, other mechanisms can be provided for the operation of the device. id="p-53" id="p-53"
[0053]In some examples, as illustrated in FIG. 3B, device 10 for drawing blood comprises: a collection tube storage unit 210; a plurality of blood collection tubes 220 stored in collection tube storage unit 210; and a translation mechanism 230. In some examples, translation mechanism 230 comprises a robotic arm and/or a track mechanism (not shown for simplicity). In some examples, the track mechanism of translation mechanism 230 comprises a conveyor belt. Particularly, in some examples, the robotic arm of translation mechanism 230 is controlled by control unit 60 to secure a respective blood collection tube to distal end 162 of lumen 160. In some examples, the track mechanism of translation mechanism 230 first translates the respective blood collection tube 220 to a predetermined position in relation to lumen 160, and then the robotic arm secures the respective blood collection tube 220 to distal end 162 of lumen 160. id="p-54" id="p-54"
[0054]In some examples, control unit 60 selects a respective one of the plurality of blood collection tubes 220 responsive to a user input. Particularly, in some examples, control unit is configured to receive a user input from: a console; a wireless signal from an external device, such as a smartphone; and/or a signal from an external server, such as the internet. The user input indicates what type of blood collection tube 220 is required. id="p-55" id="p-55"
[0055]Particularly, in some examples, collection tube storage unit 210 contains different types of blood collection tubes 220, such as: collection tubes containing no anticoagulants or preservatives; collection tubes containing a clot activator and gel for separating serum from cells; collection tubes containing Ethylenediaminetetraacetic acid (EDTA); collection tubes containing sodium fluoride and potassium oxalate; collection tubes containing sodium citrate; collection tubes containing sodium heparin or lithium heparin; and/or collection tubes containing acid citrate dextrose (ACD) solution. In some examples, collection tube storage unit 210 comprises a plurality of the types of blood collection tubes 220 described above, or from additional types not described herein, however this is not meant to be limiting in any way. In some examples, collection tube storage unit 210 comprises only a single type of blood collection tubes 220. id="p-56" id="p-56"
[0056]In some examples, the user input indicates what blood test is required, and control unit 60 determines what type of blood collection tube 220 is required for the particular blood test, such as be comparing the blood test to a look up table stored in memory 70. In some examples, responsive to the selection of the type of blood collection tube 220, a blood collection tube 220 of that type is secured to lumen 160, as described above. In some examples (not shown), collection tube storage unit 210 comprises a plurality of storage sub-units, each sub-unit comprising a respective type of blood collection tubes 220. In some examples, translation mechanism 230 is controlled by control unit 60 to alternately present different sub- units to lumen 160 and/or to a robotic arm in accordance with the determination of the required type of blood collection tube 220. id="p-57" id="p-57"
[0057]In some examples, the user enters their information and/or a dedicated sensor is provided to receive the user information, such as an RFID reader or a barcode scanner. In some examples, the user information is transmitted to an external network, such as a hospital network, and data is received from the external network to indicate which blood test are required. id="p-58" id="p-58"
[0058]Although the above has been described in relation to examples where a blood collection tube 220 is selected in response to a user input, this is not meant to be limiting in any. In some examples, memory 70 has stored therein a preprogrammed blood draw plan, and the blood collection tube 220 is selected in accordance with the preprogrammed blood draw plan. id="p-59" id="p-59"
[0059]Although the above has been described in relation to examples where a blood collection tube 220 is selected by control unit 60, this is not meant to be limiting in any way. In some examples, blood collection tubes 220 are stored in collection tube storage unit 210 in a predetermined order, such as in a row, and for each blood draw the next blood collection tube 220 of the row is used. id="p-60" id="p-60"
[0060]In some examples, as illustrated in FIG. 3B, device 10 for drawing blood further comprises: one or more heparin reservoirs 250, each comprising a predetermined volume of heparin; one or more saline reservoirs 260, each comprising a predetermined volume of saline, such as a solution of 0.90% w/v of NaCI; and a pump 270. In some examples, pump 270 is power by power source 32. In some examples, a heparin reservoir 250 is secured to distal end 182 of lumen 180. In some examples, a saline reservoir 260 is secured to distal end 171 of lumen 170. In some examples, a plurality of heparin reservoirs 250 and a plurality of saline reservoirs 260 are provided and translation mechanism 230 is further configured to alternately attach and replace different heparin reservoirs 250 and different saline reservoirs as required, as described in relation to blood collection tubes 220. id="p-61" id="p-61"
[0061]In some examples, at least one pump 270 is secured to first end 191 of lumen 190. In some examples, pump 270 is a bi-directional pump and control unit 60 can control pump 270 to draw fluid into lumen 190 and expel fluid out of lumen 190. id="p-62" id="p-62"
[0062]Although pump 270 is illustrated herein as being connected directly to lumen 1of the Y-connector, this is not meant to be limiting in any way. In some examples, as illustrated in FIG. 3C, multi-channel unit 140 further comprises a lumen 280 extending from a proximal end 281 to a distal end 282. For simplicity, portions of multi-channel unit 140 are not shown. id="p-63" id="p-63"
[0063]In some examples, proximal end 281 of lumen 280 is secured to distal end 192 of lumen 190 and pump 270 is secured to distal end 282 of lumen 280. In some examples, lumen 280 is generally transparent. In some examples, lumen 280 has predefined markings thereon to indicate the volume of fluid contained therewithin, such as syringe markings. id="p-64" id="p-64"
[0064]In some examples, device 10 for drawing blood further comprises: an optical sensor 290, whose field of view covers lumen 280; and/or a weight sensor 300 situated underneath lumen 280. In some examples, responsive to an output of optical sensor 290, control unit determines the volume of fluid currently contained in lumen 280. In some examples, responsive to the output of optical sensor 290, control unit 60 determines the velocity at which fluid is flowing through lumen 280 and/or lumen 190. id="p-65" id="p-65"
[0065]In some examples, where weight sensor 300 is provided, control unit 60 determines the weight of fluid contained within lumen 280 based on the output of weight sensor 300. In some examples, based at least in part on the determined fluid weight, and the type of fluid, control unit 60 determines the volume of fluid contained within lumen 280. In some examples, based at least in part on the determined volume or weight of fluid contained within lumen 280, and the rate of change of the determined volume or weight, control unit 60 determines the velocity at which fluid is flowing through lumen 280 and/or lumen 190. id="p-66" id="p-66"
[0066]In some examples, control unit 60 controls pump 270 to perform a blood draw, as follows. In a first blood draw step, control unit 60 controls the clamp 200 of lumen 150 to unclamp lumen 150, and further controls pump 270 to draw a predetermined initial volume of blood from the IV catheter 310. In some examples, the predetermined initial volume of blood is 3 - 5 milliliters. In a second blood draw step, control unit 60 controls the fluid path controller 200 of lumen 150 to close lumen 150 and controls the fluid path controller 200 of lumen 1to open lumen 160. Control unit 60 then controls pump 270 to inject the predetermined initial blood volume into a respective blood collection tube 220. In some examples, the initial blood volume will be discarded. id="p-67" id="p-67"
[0067]Thus, in the combination of the first blood draw step and the second blood draw step, control unit 60 controls actuator 195 to provide a respective fluid path between distal end 311 of IV catheter 310 and the respective blood collection tube 220. The term "fluid path", as used herein, means a path where fluid can flow therethrough. However, it is noted that different sections of the fluid path can be provided sequentially. Particularly, in the first blood draw step, the section of the fluid path from IV catheter 310 to lumen 190 is provided. In the second blood draw step, the section of the fluid path from lumen 190 to blood collection tube 220 is provided. id="p-68" id="p-68"
[0068]In a third blood draw step, control unit 60 controls the fluid path controller 200 of lumen 160 to close lumen 160, controls translation mechanism 230 to replace the blood collection tube 220 and controls the fluid path controller 200 of lumen 150 to open lumen 150. Control unit 60 then controls pump 270 to draw a predetermined sample volume of blood from the IV catheter 310. In some examples, the predetermined sample volume of blood is determined responsive to a user input or to a preprogrammed blood draw plan. id="p-69" id="p-69"
[0069]For example, for a coagulation test, 2.7 ±0.2 cc of blood (for adults), or about 1.+0.1 cc of blood (for children) can be drawn. Utilizing device 10, an accurate volume can be drawn. For a chemistry test, blood can be filled until the dedicated mark on the test tube (±20%). Utilizing device 10, an accurate volume can be drawn. For an Ammonia test, 3 ±1.cc of blood can be drawn. Utilizing device 10, an accurate volume can be drawn. For a complete blood count (CBC) test, blood can be filled until the dedicated mark on the test tube (±20%). Utilizing device 10, an accurate volume can be drawn. id="p-70" id="p-70"
[0070]In a fourth blood draw step, control unit 60 controls the clamp 200 of lumen 150 to clamp lumen 150 and controls the clamp 200 of lumen 160 to unclamp lumen 160. Control unit 60 then controls pump 270 to inject the predetermined sample volume of blood into a respective blood collection tube 220. id="p-71" id="p-71"
[0071]If more blood tests need to be performed, the third and fourth blood draw steps are repeated as necessary. id="p-72" id="p-72"
[0072]Although the above has been described in relation to examples where all blood is drawn through the same blood collection tube 220, this is not meant to be limiting in any way. In some examples, in the first blood draw step (to draw the initial blood volume which is discarded), lumen 150 is connected to a respective tube or other receptacle to receive the initial blood volume, and in the third blood draw step lumen 150 is connected to a respective test tube or to pump 270. id="p-73" id="p-73"
[0073]Once the blood draws are completed, control unit 60 continues to the flushing phase. In a first saline flushing step, control unit 60 controls the fluid path controller 200 of lumen 160 to close lumen 160 and controls the fluid path controller 200 of lumen 170 to open lumen 170. Control unit 60 then controls pump 270 to draw a predetermined volume of saline from saline reservoir 260. In some examples, the predetermined volume is about 10 milliliters. In a second saline flushing step, control unit 60 controls the fluid path controller 200 of lumen 1to close lumen 170 and controls the fluid path controller 200 of lumen 150 to open lumen 150. Control unit 60 then controls pump 270 to inject the predetermined volume of saline into the IV catheter 310. In some examples, the saline is injected utilizing a predetermined plurality of pulses. In some examples, the pulses are provided at predetermined fixed intervals. id="p-74" id="p-74"
[0074]Thus, in the combination of the first saline flushing step and the second saline flushing step, a respective fluid path is provided between IV catheter 310 and saline reservoir 260 is provided. Particularly, in the first saline flushing step, the section in the fluid path from saline reservoir 260 to lumen 150 is provided. In the second saline flushing step, the section in the fluid path from lumen 150 to IV catheter 310 is provided. id="p-75" id="p-75"
[0075]In some examples, an input is received indicating the type of connector being used for IV catheter 310. In some examples, the input comprises a user input. In some examples, a sensor is provided (such as an optical sensor) to identify the type of connector being used. In some examples, it is determined whether the connector is a positive pressure connector, a negative pressure connector, a neutral connector or a bi-directional connector. id="p-76" id="p-76"
[0076]In some examples, in the event that a negative pressure connector is provided, control unit 60 controls the fluid path controller 200 of lumen 150 to close lumen 150 before completing the injection of the saline. In some examples, in the event that a positive pressure connector is provided, control unit 60 control the fluid path controller 200 of lumen 150 to close lumen 150 are completing the injection of the saline. id="p-77" id="p-77"
[0077]In a first heparin flushing step, control unit 60 controls the fluid path controller 2of lumen 150 to close lumen 150 and controls the fluid path controller 200 of lumen 180 to open lumen 180. Control unit 60 then controls pump 270 to draw a predetermined volume of heparin from heparin reservoir 250. In some examples, the predetermined volume is about milliliters. In a second heparin flushing step, control unit 60 controls the fluid path controller 200 of lumen 180 to close lumen 180 and controls the fluid path controller 200 of lumen 1to open lumen 150. Control unit 60 then controls pump 270 to inject the predetermined volume of heparin into the IV catheter 310. In some examples, the heparin is injected utilizing a predetermined plurality of pulses. In some examples, the pulses are provided at predetermined fixed intervals. id="p-78" id="p-78"
[0078]Thus, in the combination of the first heparin flushing step and the second heparin flushing step, a respective fluid path is provided between IV catheter 310 and heparin reservoir 250. Particularly, in the first heparin flushing step, the section in the fluid path from heparin reservoir 250 to lumen 150 is provided. In the second heparin flushing step, the section in the fluid path from lumen 150 to IV catheter 310 is provided. id="p-79" id="p-79"
[0079]In some examples, control unit 60 controls the fluid path controller 200 of lumen 150 to clamp lumen 150. The user can then disconnect the IV catheter 310 from lumen 150. id="p-80" id="p-80"
[0080]As described above in relation to the saline flushing stage, in some examples, in the event that a negative pressure connector is provided, control unit 60 controls the fluid path controller 200 of lumen 150 to close lumen 150 before completing the injection of the heparin. In some examples, in the event that a positive pressure connector is provided, control unit control the fluid path controller 200 of lumen 150 to close lumen 150 are completing the injection of the heparin. id="p-81" id="p-81"
[0081]In some examples, as illustrated in FIG. 3B, device 10 further comprises a pressure release valve 320. In some examples, pressure release valve 320 is situated within connection lumen 150, however this is not meant to be limiting in any way. In some examples, pressure release valve 320 limits the pressure provided by pump 270 in the saline flushing stage and the heparin flushing stage to a predetermined maximum value. In some examples, the pressure release valve 320 is designed to mechanically release pressure when reaching the predetermined maximum value. id="p-82" id="p-82"
[0082]In some examples, a pressure sensor 330 is further provided, pressure sensor 3configured to measure fluid pressure values. In some examples, pressure sensor 330 is positioned anywhere along the fluid path, such that the pressure of the fluid flow can be measured. In some examples, pressure sensor 330 senses when the predetermined maximum value is reached, and the pressure is released responsive to an output of the pressure sensor 330. In some examples, pressure release valve 320 can release air that is caught within the system. id="p-83" id="p-83"
[0083]In some examples, a flow sensor 340 is further provided, flow sensor 3configured to measure fluid flow rates. In some examples, flow sensor 340 is positioned anywhere along the fluid path, such that the pressure of the fluid flow can be measured. id="p-84" id="p-84"
[0084]Long-term central venous catheters (CVC) facilitate care for patients with chronic illnesses, but catheter occlusions and catheter-related thrombosis (CRT) are common complications. Thrombotic occlusions usually resolve with thrombolytic therapy, such as alteplase. Prophylaxis with thrombolytic flushes may decrease CVC infections and CRT. id="p-85" id="p-85"
[0085]CVC occlusions can be categorized as mechanical, chemical, or thrombotic. Mechanical occlusions are related to internal or external problems with the catheter. They can be the result of issues such as catheter or tubing kinks, CVC dislodgement or tip migration, a clogged cap or other various mechanical issues. Chemical occlusions are related to medication or drug precipitate and can specifically be the result of precipitate from the mixing of incompatible drugs and solutions or lipid residue. It is estimated that mechanical and chemical occlusions account for 42% of CVC occlusions. Thrombotic occlusions account for the remaining 58% of CVC occlusions and are related to the formation of thrombi within or around the CVC or in a surrounding vessel. The degree of CVC occlusion can be categorized as partial, withdrawal, or complete. id="p-86" id="p-86"
[0086]In addition to causing catheter dysfunction, CVC thrombotic occlusions can lead to catheter-related thrombosis (CRT). This refers to a thrombus that has attached to the catheter and has also adhered to the vessel wall. CRT is associated with catheter-related bloodstream infection (CRBSI), a serious and potentially life-threatening complication. A broad body of literature demonstrates that CRT increases the risk and incidence of CRBSI and (conversely) that the presence of CRBSI can increase the risk and incidence of CRT. id="p-87" id="p-87"
[0087]Catheter salvage is the preferred approach to the management of CVAD occlusions. Restoring patency to the CVAD (rather than device removal) is less time consuming, is more convenient, and ensures limited interruption of therapy, reduced trauma and psychological stress to the patient, reduced risk of complications, and decreased costs. id="p-88" id="p-88"
[0088]Restoration of catheter patency supports the longevity of the device’s lifespan, as many CVADs can have a lifespan of multiple years. The cost of device replacement can be an estimated $200 to $1,500 and far exceeds the cost of thrombolysis (which has a drug cost of approximately $65) as well as the costs of supplies, nursing time, and clinic time. id="p-89" id="p-89"
[0089]However, detection of CVC occlusion in its early stage is difficult as it is based on subjective assessment caregivers and luck needed accuracy. Moreover, once the occlusion is suspected, a successful restoration of catheter patency requires following procedures that are not always implemented. id="p-90" id="p-90"
[0090]In some examples, when fluid is pumped into IV catheter 310, flow sensor 3measures the flow rate of the pumped fluid. In some examples, pressure sensor 330 measures the pressure of the pumped fluid as well. In some examples, control unit 60 compares the measured flow rate, at the particular pressure level (optionally measured by pressure sensor 330), to one or more predetermined values. In some examples, each value represents the expected flow rate, at a given pressure level, for a certain percentage of occlusion in IV catheter 310. In some examples, a model is stored in memory 70, the model representing expected flow rates, at given pressure levels, for one or more percentages of occlusion. In some examples, the model is based on a neural network. In some examples, based at least on the above comparison, control unit 60 determines the percentage of occlusion. In some examples, control unit outputs a signal indicating the percentage of occlusion. In some examples, the indication of the percentage of occlusion is output at a user display. id="p-91" id="p-91"
[0091]In some examples, in the event that control unit 60 detects an occlusion, based at least in part on the above comparison, control unit 60 performs a predetermined occlusion flushing stage. In some examples, in the occlusion flushing stage, control unit 60 controls pump 270 to flush IV catheter 310 with a predetermined volume of saline, at a predetermined flow rate and/or pressure value. In some examples, the occlusion flushing stage is performed for a predetermined time period. In some examples, the occlusion flushing stage is performed unit control unit 60 determines that the occlusion has been removed. In some examples, the occlusion flushing stage is performed in response to a user input. id="p-92" id="p-92"
[0092]In some examples, after the occlusion flushing stage, control unit 60 determines the percentage of occlusion and outputs the determined percentage. This allows the medical team to decide the next course of action (e.g., inject an anti-coagulant, flush IV catheter 310, decide on no intervention, or other). id="p-93" id="p-93"
[0093]In some examples, control unit 60 collects patient data, such as the cumulative volume of blood drawn and/or the volume of fluids administered (e.g., saline and heparin). In some examples, the collected data is stored in a patient file to be added to tracking of the fluid balance of the patient. In some examples, based at least in part on the cumulative volume of blood drawn, and other patient parameters, such as patient weight and/or hemoglobin levels, control unit 60 outputs an alert if too much blood is drawn. id="p-94" id="p-94"
[0094]In some examples, a temperature sensor 350 is provided. In some examples, temperature sensor 350 is placed as close as possible to IV catheter 310. In some examples, temperature sensor 350 measures the temperature of blood being drawn, and control unit can output the measured temperature value. In some examples, the output temperature value is output to a user display and/or stored within a patient file. In some examples, the temperature measurement provides an accurate measurement of the patient's core temperature. id="p-95" id="p-95"
[0095]Although the above has been described in relation to examples where blood is drawn using one or more pumps, this is not meant to be limiting in any way. In some examples (not shown), proximal end 161 of lumen 160 extends from distal end 152 of lumen 150. In such examples, blood collection tubes 220 are vacutainer blood collection tubes, and blood is drawn from IV catheter 310 due to the vacuum of blood collection tube 220 when connected to distal end 162 of lumen 160. id="p-96" id="p-96"
[0096]Although the above has been described in relation to examples where device comprises multi-channel unit 140, this is not meant to be limiting in any way. In some examples (not shown), connection lumen 150 or IV catheter 310 is alternately connected to separate mechanisms for each of the blood draw, the saline flushing and the heparin flushing. id="p-97" id="p-97"
[0097]In some examples, a separate pump (e.g., a peristaltic pump) is provided for each of heparin reservoir 250 and saline reservoir 260, each pump configured to pump the respective liquid through to IV catheter 310. In some examples, a 4 (or 5) way valve is provided at the distal end of connection lumen 150, the valve controlled by control unit 60 such that each path is separately selected. id="p-98" id="p-98"
[0098]Although the above has been described in relation to examples where flushing is performed with saline and heparin, this is not meant to be limiting in any way. In some examples, the saline and/or the heparin are replaced by different liquids. id="p-99" id="p-99"
[0099]Although the above has been described in relation to examples which include drawing blood, this is not meant to be limiting in any way. In some examples, device 10 can provide for periodic maintenance of the CVAD, which is typically required once a week. For example, in such a maintenance setting, device 10 can perform the flushing stage, or stages, without drawing any blood. id="p-100" id="p-100"
[00100]FIGs. 4A - 40 illustrate various views of an exemplary implementation of device 10. For simplicity, not all elements of device 10 are shown in FIGs. 4A - 4D. In some examples, as shown in FIG. 4A, housing 20 contains the elements of device 10. Housing 20 is not shown in FIGs. 4B - 4D. In some examples, as shown in FIGs. 4A - 4B, collection tube storage unit 210 has a housing 400 containing blood collection tubes 220, housing 400 not shown in FIGs. 4C - 4D. id="p-101" id="p-101"
[00101]In some examples, as shown, collection tube storage unit 210 comprises a plurality of translation mechanism 230 comprises a plurality of vertical units 410, each vertical unit 4configured to hold a plurality of blood collection tubes 220. id="p-102" id="p-102"
[00102]In some examples, as shown, translation mechanism 230 comprises a rotatable platform 420 and a mechanical gripper 430. In some examples, rotatable platform 420 is rotated such that mechanical gripper is juxtaposed with collection tube storage unit 210 and grips a blood collection tube 220 that faces it. In some examples, collection tube storage unit 210 is also rotatable, such that a particular blood collection tube 220 (e.g., a particular type) is positioned in relation to mechanical gripper 430. In some examples, once the blood collection tube 220 is gripped, rotatable platform 420 rotates mechanical gripper 430 such that it faces multi-channel unit 140, and is connected to blood lumen 160. As further shown, multi-channel unit 140 comprises collection lumen 150, saline lumen 180 and pump lumen 190. In some examples, an additional lumen 440 is provided in multi-channel unit 140 such that blood collection tubes 220 can be externally connected, not via collection tube storage unit 210. In some examples, multi-channel unit 140 and pump 270 are contained within a housing 435, housing 435 not shown in FIG. 4D. id="p-103" id="p-103"
[00103]In some examples, as shown, saline reservoir 260 is provided, and heparin reservoir 250 is not provided. In some examples, heparin lumen 170 is thus also not provided. In some examples, injection of heparin is not part of the protocol and is thus not provided. In some examples, heparin is mixed together with the saline. id="p-104" id="p-104"
[00104]In some examples, as shown in FIGs. 4A - 4C, device 10 further comprises a barcode scanner 450 and a user display 460. In some examples, barcode scanner 450 can be used for scanning barcodes on blood collection tubes 220 and user display can display information output by control unit 60, as described above. id="p-105" id="p-105"
[00105]In some examples, as described above, device 10 provides one or more of the following advantages:a. Identification of the patient and/or integration with a hospital system;b. A closed sterile system;c. Integrated disinfection;d. Pressure controlled flushing;e. Controlled amount of blood in test tubes.
Some Examples of the Disclosed Technology id="p-106" id="p-106"
[00106]Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application. id="p-107" id="p-107"
[00107]Example 1. A device for drawing blood from an intravenous (IV) catheter, the device comprising: an actuator; at least one pump; and a control unit configured to: in a drawing stage, control the actuator to provide a respective fluid path between a distal end of an IV catheter and at least one blood collection tube, in a first flushing stage, subsequent to the drawing stage, control the actuator to provide a respective fluid path between the distal end of the IV catheter and a first liquid reservoir, and control the at least one pump to pump a predetermined volume of first liquid from the first liquid reservoir into the IV catheter. id="p-108" id="p-108"
[00108]Example 2. The device of any example herein, particularly example 1, wherein the control unit is configured, in a second flushing stage, subsequent to the first flushing stage, to control the actuator to provide a respective fluid path between the distal end of the IV catheter and a second liquid reservoir, and control the at least one pump to pump a predetermined volume of second liquid from the second liquid reservoir into the IV catheter. id="p-109" id="p-109"
[00109]Example 3. The device of any example herein, particularly example 2, wherein the first liquid is saline. id="p-110" id="p-110"
[00110]Example 4. The device of any example herein, particularly example 2, wherein the second liquid is heparin. id="p-111" id="p-111"
[00111]Example 5. The device of any example herein, particularly any one of examples - 4, wherein the predetermined volume of the second liquid is pumped in a predetermined plurality of pulses. id="p-112" id="p-112"
[00112]Example 6. The device of any example herein, particularly any one of examples I - 5, wherein the predetermined volume of the second liquid is pumped in a predetermined plurality of pulses. id="p-113" id="p-113"
[00113]Example 7. The device of any example herein, particularly any one of examples I - 6, further comprising at least one pressure release valve configured to limit the pressure provided by the at least one pump in the first flushing stage. id="p-114" id="p-114"
[00114]Example 8. The device of any example herein, particularly example 7, wherein the at least one pressure release valve is situated within the respective fluid path between the IV catheter and the first liquid reservoir. id="p-115" id="p-115"
[00115]Example 9. The device of any example herein, particularly any one of examples I - 8, wherein, in the drawing stage, the control unit is further configured to control the at least one pump to pump a predetermined volume of blood from the IV catheter into the at least one blood collection tube. id="p-116" id="p-116"
[00116]Example 10. The device of any example herein, particularly example 9, further comprising at least one fluid sensor configured to output information associated with the velocity of blood being pumped by the at least one pump, wherein the control unit is further configured to: based at least in part on the output of the at least one fluid sensor, determine the velocity of flow of the blood being pumped by the at least one pump; and based at least in part on the determined flow velocity, control the at least one pump to limit the velocity of flow to a predetermined maximum value. id="p-117" id="p-117"
[00117]Example 11. The device of any example herein, particularly example 10, wherein the at least one sensor comprises an optical sensor or a weight sensor. id="p-118" id="p-118"
[00118]Example 12. The device of any example herein, particularly any one of examples 1-11, further comprising a tube translation mechanism, wherein, in the drawing stage, the at least one blood collection tube comprises a plurality of blood collection tubes, and wherein, in the drawing stage, the control unit is configured to: control the tube translation mechanism to sequentially translate each of the plurality of blood collection tubes to a predetermined position in relation to the IV catheter. id="p-119" id="p-119"
[00119]Example 13. The device of any example herein, particularly any one of examples -12, further comprising a multi-channel unit, the multi-channel unit comprising: a connection lumen extending from a proximal end to a distal end, the proximal end of the connection lumen configured to be connected to the distal end of the TV catheter such that a respective fluid path is provided between the distal end of the IV catheter and the connection lumen; a blood lumen extending from a proximal end to a distal end, the distal end of the blood lumen configured to be detachably coupled to the at least one blood collection tube, and wherein the proximal end of the blood lumen is in fluid communication with the distal end of the connection lumen; a first liquid lumen extending from a proximal end to a distal end, the distal end of the first liquid lumen in fluid communication with the first liquid reservoir, and wherein the proximal end of the first liquid lumen is in fluid communication with the distal end of the connection lumen; and a pump lumen extending from a proximal end to a distal end, the distal end of the pump lumen in fluid communication with the at least one pump, and wherein the proximal end of the pump lumen is in fluid communication with the distal end of the connection lumen. id="p-120" id="p-120"
[00120]Example 14. The device of any example herein, particularly example 13, wherein the fluid path between the IV catheter and the first liquid reservoir comprises the connection lumen, the first liquid lumen and the pump lumen. id="p-121" id="p-121"
[00121]Example 15. The device of any example herein, particularly any one of examples - 14, wherein the fluid path between the IV catheter and the at least one blood collection tube comprises the connection lumen and the blood lumen. id="p-122" id="p-122"
[00122]Example 16. The device of any example herein, particularly example 15, wherein the fluid path between the IV catheter and the at least one blood collection tube further comprises the pump lumen. id="p-123" id="p-123"
[00123]Example 17. The device of any example herein, particularly any one of examples - 16, wherein the blood lumen, the first liquid lumen and the pump lumen extend from a common point of the distal end of the connection lumen. id="p-124" id="p-124"
[00124]Example 18. The device of any example herein, particularly any one of examples - 17, wherein the actuator comprises a plurality of fluid path controllers, wherein a first of the plurality of fluid path controllers is attached to the connection lumen, a second of the plurality of fluid path controllers is attached to the first liquid lumen, wherein the actuator provides the respective fluid path between the IV catheter and the first liquid reservoir by: in an initial first liquid stage, controlling the first fluid path controller to allow fluid flow through the first liquid lumen and controlling the second fluid path controller to prevent fluid flow through the connection lumen; and in a second first liquid stage, subsequent to the first initial liquid stage, controlling the first fluid path controller to prevent fluid flow through the first liquid lumen and controlling the second fluid path controller to allow fluid flow through the connection lumen. id="p-125" id="p-125"
[00125]Example 19. The device of any example herein, particularly example 18, wherein during the initial first liquid stage the control unit is configured to control the at least one pump to pump the predetermined volume of first liquid from the first liquid reservoir into the pump lumen, and wherein during the second first liquid stage the control unit is configured to control the at least one pump to pump the predetermined volume of first liquid from the pump lumen into the connection lumen. id="p-126" id="p-126"
[00126]Example 20. The device of any example herein, particularly any one of examples - 19, wherein each of the plurality of fluid path controllers comprises a clamp or a valve. id="p-127" id="p-127"
[00127]Example 21. The device of any example herein, particularly any one of examples - 20, further comprising a disinfection mechanism configured to disinfect the distal end of the IV catheter. id="p-128" id="p-128"
[00128]Example 22. The device of any example herein, particularly example 21, wherein the disinfection mechanism comprises an ultraviolet (UV) light source. id="p-129" id="p-129"
[00129]Example 23. The device of any example herein, particularly example 21 or 22, wherein the disinfection mechanism comprises: an antiseptic reservoir comprising antiseptic liquid; and a spray mechanism configured to spray droplets of the antiseptic liquid from the antiseptic reservoir, wherein the control unit is configured to control the spray mechanism to spray the distal end of the IV catheter with a predetermined amount of the antiseptic liquid. id="p-130" id="p-130"
[00130]Example 24. The device of any example herein, particularly example 21 or 22, wherein the disinfection mechanism comprises a wiping mechanism, and wherein the control unit is configured to control the wiping mechanism to wipe the distal end of the IV catheter with material soaked with antiseptic liquid. id="p-131" id="p-131"
[00131]Example 25. The device of any example herein, particularly example 21 or 22, wherein the disinfection mechanism comprises: an antiseptic reservoir comprising antiseptic liquid; and a dipping mechanism, and wherein the control unit is configured to control with dipping mechanism to dip the distal end of the IV catheter into the antiseptic liquid. id="p-132" id="p-132"
[00132]Example 26. The device of any example herein, particularly any one of examples 1-25, further comprising: at least one catheter sensor configured to output an indication of a location of the distal end of the IV catheter; and a robotic arm, wherein, based at least in part on the output indication of the at least one catheter sensor, the control unit is configured to control the robotic arm to grip the distal end of the IV catheter and move the distal end of the IV catheter to a predetermined position. id="p-133" id="p-133"
[00133]Example 27. The device of any example herein, particularly example 26, wherein the at least one catheter sensor comprises an optical sensor. id="p-134" id="p-134"
[00134]Example 28. The device of any example herein, particularly example 26 or 27, further comprising a surface, wherein the at least one catheter sensor comprises a plurality of pressure sensors, each of the plurality of pressure sensors configured to output a respective signal responsive to the distal end of the IV catheter being placed on a respective portion of the surface. id="p-135" id="p-135"
[00135]Example 29. The device of any example herein, particularly example 26 or 27, further comprising a surface, wherein the at least one catheter sensor comprises a plurality of force sensors, each of the plurality of force sensors configured to output a respective signal responsive to the distal end of the IV catheter being placed on a respective portion of the surface. id="p-136" id="p-136"
[00136]Example 30. The device of any example herein, particularly any one of examples - 29, further comprising a flow sensor to measure a flow rate of the first liquid, wherein the control unit is configured, based at least in part on the measured flow rate, to identify an occlusion. id="p-137" id="p-137"
[00137]Example 31. The device of any example herein, particularly example 30, wherein responsive to the detection of an occlusion, the control unit controls the at least one pump to pump an additional volume of first liquid from the first liquid reservoir into the IV catheter. id="p-138" id="p-138"
[00138]Example 32. The device of any example herein, particularly any one of examples 1-33, further comprising a temperature sensor configured to measure temperature of blood the drawing stage. id="p-139" id="p-139"
[00139]It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. id="p-140" id="p-140"
[00140]Unless otherwise defined, all technical and scientific terms used herein have the same meanings as are commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods are described herein. id="p-141" id="p-141"
[00141]All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. id="p-142" id="p-142"
[00142]It will be appreciated by persons skilled in the art that the present invention is notlimited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined by the appended claims and includes both combinations and subcombinations of the various features described hereinabove as well as variations and modifications thereof which would occur to persons skilled in the art upon reading theforegoing description.

Claims (32)

PCT/IL2024/050337 CLAIMS
1. A device for drawing blood from an intravenous (IV) catheter, including central venous access devices, the device comprising:an actuator;at least one pump; anda control unit configured to:in a drawing stage, control the actuator to provide a respective fluid path between a distal end of an IV catheter and at least one blood collection tube,in a first flushing stage, subsequent to the drawing stage, control the actuator to provide a respective fluid path between the distal end of the IV catheter and a first liquid reservoir, and control the at least one pump to pump a predetermined volume of first liquid from the first liquid reservoir into the IV catheter.
2. The device of claim 1 wherein the control unit is configured, in a second flushing stage, subsequent to the first flushing stage, to control the actuator to provide a respective fluid path between the distal end of the IV catheter and a second liquid reservoir, and control the at least one pump to pump a predetermined volume of second liquid from the second liquid reservoir into the IV catheter.
3. The device of claim 2, wherein the first liquid is saline.
4. The device of claim 3, wherein the second liquid is heparin.
5. The device of any one of claims 2-4, wherein the predetermined volume of the second liquid is pumped in a predetermined plurality of pulses.
6. The device of any one of claims 1-5, wherein the predetermined volume of the first liquid is pumped in a predetermined plurality of pulses.
7. The device of any one of claims 1-6, further comprising at least one pressure release valve configured to limit the pressure provided by the at least one pump in the first flushing stage. PCT/IL2024/050337
8. The device of claim 7, wherein the at least one pressure release valve is situated within the respective fluid path between the IV catheter and the first liquid reservoir.
9. The device of any one of claims 1-8, wherein, in the drawing stage, the control unit is further configured to control the at least one pump to pump a predetermined volume of blood from the IV catheter into the at least one blood collection tube.
10. The device of claim 9, further comprising at least one fluid sensor configured to output information associated with the velocity of blood being pumped by the at least one pump, wherein the control unit is further configured to:based at least in part on the output of the at least one fluid sensor, determine the velocity of flow of the blood being pumped by the at least one pump; andbased at least in part on the determined flow velocity, control the at least one pump to limit the velocity of flow to a predetermined maximum value.
11. The device of claim 10, wherein the at least one sensor comprises an optical sensor or a weight sensor.
12. The device of any one of claims 1-11, further comprising a tube translation mechanism, wherein, in the drawing stage, the at least one blood collection tube comprises a plurality of blood collection tubes, andwherein, in the drawing stage, the control unit is configured to:control the tube translation mechanism to sequentially translate each of the plurality of blood collection tubes to a predetermined position in relation to the IV catheter.
13. The device of any one of claims 1 - 12, further comprising a multi-channel unit, the multi- channel unit comprising:a connection lumen extending from a proximal end to a distal end, the proximal end of the connection lumen configured to be connected to the distal end of the IV catheter such that a respective fluid path is provided between the distal end of the IV catheter and the connection lumen;a blood lumen extending from a proximal end to a distal end, the distal end of the blood lumen configured to be detachably coupled to the at least one blood collection tube, and PCT/IL2024/050337 wherein the proximal end of the blood lumen is in fluid communication with the distal end of the connection lumen;a first liquid lumen extending from a proximal end to a distal end, the distal end of the first liquid lumen in fluid communication with the first liquid reservoir, and wherein the proximal end of the first liquid lumen is in fluid communication with the distal end of the connection lumen; anda pump lumen extending from a proximal end to a distal end, the distal end of the pump lumen in fluid communication with the at least one pump, and wherein the proximal end of the pump lumen is in fluid communication with the distal end of the connection lumen.
14. The device of claim 13, wherein the fluid path between the IV catheter and the first liquid reservoir comprises the connection lumen, the first liquid lumen and the pump lumen.
15. The device of any one of claims 13 - 14, wherein the fluid path between the IV catheter and the at least one blood collection tube comprises the connection lumen and the blood lumen.
16. The device of claim 15, wherein the fluid path between the IV catheter and the at least one blood collection tube further comprises the pump lumen.
17. The device of any one of claims 13 - 16, wherein the blood lumen, the first liquid lumen and the pump lumen extend from a common point of the distal end of the connection lumen.
18. The device of any one of claims 13 - 17, wherein the actuator comprises a plurality of fluid path controllers,wherein a first of the plurality of fluid path controllers is attached to the connection lumen, a second of the plurality of fluid path controllers is attached to the first liquid lumen,wherein the actuator provides the respective fluid path between the IV catheter and the first liquid reservoir by:in an initial first liquid stage, controlling the first fluid path controller to allow fluid flow through the first liquid lumen and controlling the second fluid path controller to prevent fluid flow through the connection lumen; andin a second first liquid stage, subsequent to the initial first liquid stage, controlling the first fluid path controller to prevent fluid flow through the first liquid lumen and controlling the second fluid path controller to allow fluid flow through the connection lumen. PCT/IL2024/050337
19. The device of claim 18, wherein during the initial first liquid stage the control unit is configured to control the at least one pump to pump the predetermined volume of first liquid from the first liquid reservoir into the pump lumen, andwherein during the second first liquid stage the control unit is configured to control the at least one pump to pump the predetermined volume of first liquid from the pump lumen into the connection lumen.
20. The device of any one of claims 18 - 19, wherein each of the plurality of fluid path controllers comprises a clamp or a valve.
21. The device of any one of claims 1 - 20, further comprising a disinfection mechanism configured to disinfect the distal end of the IV catheter.
22. The device of claim 21, wherein the disinfection mechanism comprises an ultraviolet (UV) light source.
23. The device of claim 21 or 22, wherein the disinfection mechanism comprises: an antiseptic reservoir comprising antiseptic liquid or gel; anda spray mechanism configured to spray droplets of the antiseptic liquid from the antiseptic reservoir,wherein the control unit is configured to control the spray mechanism to spray the distal end of the IV catheter with a predetermined amount of the antiseptic liquid.
24. The device of claim 21 or 22, wherein the disinfection mechanism comprises a wiping mechanism, andwherein the control unit is configured to control the wiping mechanism to wipe the distal end of the IV catheter with material soaked with antiseptic liquid.
25. The device of claim 21 or 22, wherein the disinfection mechanism comprises:an antiseptic reservoir comprising antiseptic liquid; anda dipping mechanism, andwherein the control unit is configured to control with dipping mechanism to dip the distal end of the IV catheter into the antiseptic liquid. PCT/IL2024/050337
26. The device of any one of claims 1-25, further comprising:at least one catheter sensor configured to output an indication of a location of the distal end of the IV catheter; anda robotic arm,wherein, based at least in part on the output indication of the at least one catheter sensor, the control unit is configured to control the robotic arm to grip the distal end of the IV catheter and move the distal end of the IV catheter to a predetermined position.
27. The device of claim 26, wherein the at least one catheter sensor comprises an optical sensor.
28. The device of claim 26 or 27, further comprising a surface,wherein the at least one catheter sensor comprises a plurality of pressure sensors, each of the plurality of pressure sensors configured to output a respective signal responsive to the distal end of the IV catheter being placed on a respective portion of the surface.
29. The device of claim 26 or 27, further comprising a surface,wherein the at least one catheter sensor comprises a plurality of force sensors, each of the plurality of force sensors configured to output a respective signal responsive to the distal end of the IV catheter being placed on a respective portion of the surface.
30. The device of any one of claims 1 - 29, further comprising a flow sensor to measure a flow rate of the first liquid,wherein the control unit is configured, based at least in part on the measured flow rate, to identify an occlusion.
31. The device of claim 30, wherein responsive to the detection of an occlusion, the control unit controls the at least one pump to pump an additional volume of first liquid from the first liquid reservoir into the IV catheter.
32. The device of any one of claims 1-31, further comprising a temperature sensor configured to measure temperature of blood during the drawing stage.
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WO2007059476A2 (en) * 2005-11-15 2007-05-24 Luminous Medical, Inc. Blood analyte determinations
US20100217154A1 (en) * 2009-02-26 2010-08-26 Catholic Healthcare West (d/b/a) St. Joseph's Hospital and Medical Center Automated blood draw system
WO2021195515A1 (en) * 2020-03-27 2021-09-30 University Of Maryland, Baltimore Device and method for automated blood draw and testing
US11717587B2 (en) * 2020-05-08 2023-08-08 Robust AI, Inc. Ultraviolet cleaning trajectory modeling
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