WO2017053584A1 - Sonde de diagnostic in vivo par voie intraveineuse - Google Patents

Sonde de diagnostic in vivo par voie intraveineuse Download PDF

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Publication number
WO2017053584A1
WO2017053584A1 PCT/US2016/053142 US2016053142W WO2017053584A1 WO 2017053584 A1 WO2017053584 A1 WO 2017053584A1 US 2016053142 W US2016053142 W US 2016053142W WO 2017053584 A1 WO2017053584 A1 WO 2017053584A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
needle
sensors
vein
diagnostic probe
Prior art date
Application number
PCT/US2016/053142
Other languages
English (en)
Inventor
John David Russell
Original Assignee
John David Russell
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 John David Russell filed Critical John David Russell
Publication of WO2017053584A1 publication Critical patent/WO2017053584A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/028—Arrangements to prevent overuse, e.g. by counting the number of uses
    • A61B2560/0285—Apparatus for single use

Definitions

  • the present invention relates to the use of an in vivo intravenous diagnostic probe
  • catheter or cannula containing a sensing component used to measure metabolic and other biomedical characteristics of host organisms and communicate conditional characteristics of interest.
  • IV delivery apparatus that incorporate sensors on them have been used to sense information inside patients' bodies.
  • PCT application WO 1999/039624 describes "Apparatus for intracardiac drug administration, including a catheter (20, 45, 64) which is inserted into a chamber of the heart and brought into engagement with a site in the heart wall (72).
  • the catheter includes at least one position sensor (32), which generates
  • a needle injection catheter includes a delivery tube that slidably surrounds a hypotube that has at least three hollow
  • needle portions connected to and extending outwardly at its distal end.
  • the needle portions are formed of resilient material and curve outwardly from the delivery tube.
  • the ends of the needle portions are shaped to penetrate tissue when the hypotube is urged out of the delivery tube.
  • a first sensor is located adjacent the distal end of the delivery tube and a second sensor is located adjacent the end of the needle portion. The sensors are electrically connected to first and second
  • Radiopaque markers are affixed to the delivery tube to locate the tip using an enhanced imaging system.
  • the markers are sized, shaped, positioned and of different densities to locate the tip both axially and radially within body structures.”
  • a biopsy needle has a central axis and includes one
  • each sensing region formed by a plurality of sensing optical fibers located over a particular extent of said central axis and inside the outer shell of the needle.
  • the sensing optical fibers are coupled to a wavelength interrogator.
  • a steerable catheter has a central axis and outer shell, the outer shell coupled to a plurality of optical fibers in sensing regions and actuation regions, the sensing regions formed over particular extents of the central axis by bonding gratings to the inner surface of the outer shell, and the actuation regions formed by
  • U.S. Patent No. 7699829 describes: "An apparatus and method for catheter-based sensing and injection at a target site within a patient's body.
  • An injection catheter is equipped with electrodes at its distal end which contact the surface of a target site, such as an AV node of the heart. Electrical signals detected at the target site by the electrodes are fed via leads to the target site.
  • proximal end of the catheter where they are received by a monitor, such as an EKG monitor. If the electrical signals satisfy predetermined criteria, a needle within the catheter is extended into the target site, and a therapeutic agent is injected into the target site.” (Abstract.)
  • the plurality of sensor elements comprising an enzyme capable of catalyzing a reaction involving a substrate for the enzyme and a reference electrode, the plurality of sensor elements disposed adjacent the shank distal end, a plurality of connector pads disposed at the shank proximal end where the plurality of connector pads are contained within the hub and the plurality of sensor elements are exposed adjacent the
  • IV line intra venous line
  • fluids, medicines and other agents needed to stabilize and sustain the life of the patients.
  • vital metabolic information provided in a metabolic panel or other tests to accurately diagnose and treat the patient until blood is drawn either from the IV line or an
  • Embodiments of this invention provide an in vivo intravenous diagnostic probe, which enables immediate continuous information to be obtained about the patient's metabolic and other biomedical characteristics such as drug dosage levels etc. in emergency situations where patients are in transit and laboratory services are not available.
  • the in vivo intravenous diagnostic probe eliminates the need for additional pain and suffering from needle sticks for laboratory tests and the opportunities for accidental needle sticks and possible transmission of blood borne pathogens to the phlebotomists.
  • the present invention provides an in vivo intravenous diagnostic probe, which includes: a flexible catheter; a plurality of sensors disposed on the surface of the catheter; a catheter holder body joined to the catheter; retractable intra venous (IV) needle inside the catheter; a retractable IV needle base :0 joined to the needle; electronic signal communication apparatus located inside the body; and signal transmitting conductors disposed inside the flexible catheter and the catheter holder body for conducting signals from the sensors to the signal communication apparatus.
  • IV intra venous
  • the present invention provides a method for using the above in vivo intravenous diagnostic probe, which includes: inserting the IV needle into a vein of a patient; :5 retracting the IV needle from the catheter, leaving the catheter in the vein; delivering a fluid into the vein via the catheter; and receiving signals from the sensors while delivering the fluid.
  • Figure 1 schematically illustrates an in vivo intravenous diagnostic probe according to an embodiment of the present invention, with a needle prior to insertion into the vein.
  • Figure 2 schematically illustrates the in vivo intravenous diagnostic probe of Fig. 1 after insertion into vein with IV bag tube connected.
  • Figure 3 is an enlarged view of area A of Fig. 2.
  • Figure 4 is an enlarged view of area B of Fig. 2.
  • Figure 5 schematically illustrates an in vivo intravenous diagnostic probe according to another embodiment of the present invention.
  • the in vivo intravenous diagnostic probe includes a flexible catheter 1 where sensors 10 are located, and retractable IV needle 2 inside the catheter.
  • the in vivo intravenous diagnostic probe further includes an IV catheter holder body 3, electronic signal communication apparatus 4 located inside the body 3, an IV needle base 5 which is retractable,
  • the signals from the sensor 10 are preferably electrical signals, but can also be optical signals or other suitable types of signals; the signal transmitting conductors 6 may be any suitable conductors that transmit the signal, including electrical conductors, optical fibers, etc.
  • the catheter 1 is for delivering fluids and acting as a substrate to structurally support the microsensors 10.
  • the IV needle 2 provides rigidity and puncture initiation for insertion.
  • the catheter holder body 3 is joined to the catheter and provides structural/mechanical support for catheter and the needle; it also provides connection to rV source and houses the electronic signal communication apparatus 4.
  • the electronic signal communication apparatus 4 receives signals
  • the IV needle base 5 acts as a structural base for the IV needle 2.
  • a plurality of sensors 10 are provided on the outside surface of the catheter 1.
  • the portions of the signal transmitting conductors 6 that are located inside the catheter wall is shown as 11. The specific types of sensors used and their configurations depend
  • the needle 2 with the catheter 1 is inserted into the patient' s vein 8 under the skin 9, and the needle is then retracted from the catheter, leaving the catheter in the vein.
  • the needle has been retracted, and an IV bag tube connection 7 replaces the IV needle base to provide a path for delivery of fluids.
  • the catheter is utilized for fluid injection through the fluid channel which is left when the needle is retracted, as is current practice. As the IV needle is
  • the sensors 10 senses the intravenous environment and communicate electrical signals via the conductors 6 to the signal communication apparatus 4, which in turn communicates information to appropriate external devices able to receive the information.
  • Communication to external devices can be accomplished by a plurality of technologies for this purpose including but not limited to RFID, induction coil potentiometric technologies, Bluetooth
  • the signal communication apparatus 4 may contain certain signal processing functions, or it may function to only transmit the signal to the external device.
  • the in vivo intravenous diagnostic probe is a single-use device, which is not intended to be reused.
  • a RFID (radio frequency) chip 12 may optionally be provided on the :0 outside surface of the catheter 1, e.g. integrated into the sensor array, to provide RFID signals transmitted from inside the vein.
  • Manufacturing of various components of the in vivo intravenous diagnostic probe may employ the use of currently available technologies for IV needle manufacture, micro circuitry deposition on substrate technologies, insert molding technologies, aseptic manufacturing
  • the in vivo intravenous diagnostic probe provides the ability to continuously monitor metabolic and clinical characteristics of organisms; it limits invasive needle sticks in addition to IV needle placement, and allows immediate results in emergency and critical care patient transit.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une sonde de diagnostic in vivo par voie intraveineuse comprenant un cathéter flexible où sont situés des capteurs, et une aiguille pour intraveineuse (IV) rétractable à l'intérieur du cathéter. La sonde comprend en outre un corps support de cathéter IV, un appareil de communication de signaux électroniques situé à l'intérieur du corps, une base d'aiguille IV qui est rétractable, et des conducteurs d'émission de signal disposés à l'intérieur du cathéter flexible et du corps pour diriger des signaux électriques provenant des capteurs vers l'appareil de communication de signaux. En cours de fonctionnement, l'aiguille est insérée avec le cathéter dans la veine du patient, et l'aiguille est ensuite rétractée, laissant le cathéter dans la veine. Le cathéter est destiné à l'injection de fluide dans la pratique actuelle. L'aiguille IV étant correctement placée dans la veine, les capteurs détectent l'environnement intraveineux et communiquent des signaux électriques via les conducteurs à l'appareil de communication de signaux, qui, à son tour, communique des informations à des dispositifs externes appropriés aptes à recevoir les informations.
PCT/US2016/053142 2015-09-24 2016-09-22 Sonde de diagnostic in vivo par voie intraveineuse WO2017053584A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562222850P 2015-09-24 2015-09-24
US62/222,850 2015-09-24

Publications (1)

Publication Number Publication Date
WO2017053584A1 true WO2017053584A1 (fr) 2017-03-30

Family

ID=58387285

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/053142 WO2017053584A1 (fr) 2015-09-24 2016-09-22 Sonde de diagnostic in vivo par voie intraveineuse

Country Status (1)

Country Link
WO (1) WO2017053584A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080249388A1 (en) * 2007-04-06 2008-10-09 Thinkvillage, Llc Systems and methods for cooling of intravenous fluid and monitoring of in vivo characteristics
US20090240121A1 (en) * 2008-03-21 2009-09-24 Nova Biomedical Corporation Intravascular sensor and insertion set combination
US7699829B2 (en) * 2004-03-25 2010-04-20 Boston Scientific Scimed, Inc. Catheter with sensor tip and method of use of same
EP2664293A1 (fr) * 2012-05-18 2013-11-20 Wimed I/S Cathéter électrophysiologique interactif
US20130338480A1 (en) * 2012-06-18 2013-12-19 Energy Management Athletics, Llc Intravenous apparatus and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7699829B2 (en) * 2004-03-25 2010-04-20 Boston Scientific Scimed, Inc. Catheter with sensor tip and method of use of same
US20080249388A1 (en) * 2007-04-06 2008-10-09 Thinkvillage, Llc Systems and methods for cooling of intravenous fluid and monitoring of in vivo characteristics
US20090240121A1 (en) * 2008-03-21 2009-09-24 Nova Biomedical Corporation Intravascular sensor and insertion set combination
EP2664293A1 (fr) * 2012-05-18 2013-11-20 Wimed I/S Cathéter électrophysiologique interactif
US20130338480A1 (en) * 2012-06-18 2013-12-19 Energy Management Athletics, Llc Intravenous apparatus and method

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