WO2012099984A1 - Stylet détectant le liquide céphalorachidien (csf) - Google Patents

Stylet détectant le liquide céphalorachidien (csf) Download PDF

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Publication number
WO2012099984A1
WO2012099984A1 PCT/US2012/021758 US2012021758W WO2012099984A1 WO 2012099984 A1 WO2012099984 A1 WO 2012099984A1 US 2012021758 W US2012021758 W US 2012021758W WO 2012099984 A1 WO2012099984 A1 WO 2012099984A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal end
cable
conductive cable
light conductive
tube
Prior art date
Application number
PCT/US2012/021758
Other languages
English (en)
Inventor
Donald Eugene BOBO Sr.
Original Assignee
Innerspace, Inc.
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 Innerspace, Inc. filed Critical Innerspace, Inc.
Publication of WO2012099984A1 publication Critical patent/WO2012099984A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/4064—Evaluating the brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • 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
    • 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
    • A61B5/6867—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 specially adapted to be attached or implanted in a specific body part
    • A61B5/6868—Brain
    • 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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006—Cerebrospinal drainage; Accessories therefor, e.g. valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/029—Humidity sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs

Definitions

  • CSF cerebrospinal fluid
  • surgeons attempt to "feel" entry into the ventricle as the catheter pops through the wall of the ventricle.
  • the surgeon may drop the level of the catheter as low as possible to see if a siphon can be created that will pull fluid from the ventricle.
  • the surgeon may have a CRT taken of the patient to know whether or not the catheter is in the ventricle.
  • a fluid sensor for sensing CSF and helping a surgeon to determine if a catheter has entered a ventricle of a brain.
  • the fluid sensor provides an indicator at the device's proximal end that remains illuminated when dry and goes dark when contacting fluid.
  • the senor includes a fiber optic cable having a distal end that is angled to reflect light traveling within the cable when dry, yet allows light to pass out of the distal end when wet.
  • the proximal end of the cable remains illuminated (when used in a well lit room) and turns dark when the distal end contacts fluid.
  • the distal end of the cable is preferably positioned at a predetermined distance from the distal end of the drainage catheter it sits within. This distance is such that when the user enters a ventricle, CSF will rise at least as high as the level of the distal end of the fiber optic cable. If the catheter should alternately enter parenchyma tissue, the small amount of CSF that might enter the catheter is insufficient to cause the level of CSF to reach the fiber optic cable, thereby distinguishing the ventricle from other nearby portions of the brain (e.g., the parenchyma).
  • Figure 1 illustrates a drainage catheter that can be used according to the present invention
  • Figure 2 illustrates a rigid outer tube having at least one aperture near its distal end according to the present invention
  • Figure 3 illustrates a fiber optic cable having an angled distal end according to the present invention
  • Figure 4A illustrates a top view of the fiber optic cable and rigid outer tube according to the present invention
  • Figure 4B illustrates a side cross sectional view of the fiber optic cable, rigid outer tube, and drainage catheter at a relatively low fluid level
  • Figure 5A illustrates a top view of the fiber optic cable and rigid outer tube according to the present invention
  • Figure 5B illustrates a side cross sectional view of the fiber optic cable, rigid outer tube, and drainage catheter at a relatively high fluid level
  • Figure 6 illustrates an exploded view of another fluid sensing device according to the present invention.
  • Figure 7 illustrates the apertures near the distal end of the rigid outer tube of the device of Figure 6;
  • Figure 8 illustrates a proximal end view of the fluid sensor device from Figure 6;
  • Figure 9 illustrates a rigid tube having multiple sets of apertures according to another embodiment of the present invention. DESCRIPTION OF EMBODIMENTS
  • FIGS 1 -5B illustrate an embodiment of a cerebrospinal fluid sensor 100 (i.e., an indicator) which provides a visual indication when fluid levels inside a drainage catheter 1 10 proximally rise to at least a predetermined level characteristic of the CSF in a ventricle. Hence the surgeon can determine if a distal end of a drainage catheter 1 10 has entered a ventricle.
  • a cerebrospinal fluid sensor 100 i.e., an indicator
  • the CFS sensor 100 generally comprises a hollow tube 1 14, seen best in Figure 2, and a fiber optic cable 120 (i.e., a light conductive cable), best seen in Figure 3.
  • the fiber optic cable 120 is located within the tube 1 14 such that a distal end 120A of the cable 120 is located at or near one or more apertures 1 16 (i.e., ports, holes or openings) in the tube 1 14, and more preferably is centered within these apertures 1 16.
  • additional sets of apertures may be included proximally and distally of apertures 1 16, allowing air to flow past the center aperture 1 16 and thereby ensure that an air bubble does not surround the distal end 120A of the fiber optic cable 120.
  • the fiber optic cable 120 has an outer diameter that is slightly smaller than the inner diameter of the tube 1 14, allowing the cable to snugly fit within.
  • the inner diameter of the tube 1 14 may be 0.052 inches and the outer diameter of the cable 120 may be 0.04 inches.
  • Adhesive or other fixture mechanisms can be used between the cable 120 and the tube 1 14 to prevent the cable 120 from longitudinal movement.
  • the apertures 1 16 and the distal end 120A are located at a predetermined distance from the distal end of the tube 1 14. This predetermined distance is such that, at a relatively low ICP pressure, CSF will move up to or proximally past the apertures 1 16, thereby contacting the distal end 120A.
  • the predetermined distance allows CSF to reach the apertures 1 16 and distal end 120A at an ICP of between about 2-3 mm/Hg when within a cranium of a patient.
  • the predetermined distance is between about 0.2 and about 1 inch from the distal end of the tube 1 14.
  • the predetermined distance is between 0.5 and about 0.7 inch from the distal end of the tube 1 14.
  • the predetermined distance is about 0.60 inches from the distal end of the tube 1 14 and the tube 1 14 has an inner diameter of about 0.062 inches. In another example, the predetermined distance is about 0.9 inches from the distal end of the tube 1 14. In this respect, even at relatively low pressures, CSF will reach the apertures and be detected by the fiber optic cable 120.
  • the apertures 1 16 and distal end 120A be located at the same distance from the distal end of the tube 1 14, in other embodiments, these elements may have different distances relative to each other.
  • the apertures 1 16 maybe located at about 0.25 inches and the distal end 120A may be located at about 0.60 inches from the distal end of the tube 1 14.
  • the tube 1 14 includes a longitudinal slit 1 18 towards the distal end of the tube 1 14 (or optionally the proximal end), through which CFS or air bubbles may pass.
  • the fiber optic cable 120 preferably senses or indicates fluid (e.g., CSF) by having a distal tip configured to selectively reflect light at its proximal end 120B ( Figures 4A and 5A). More specifically, the distal end 120A is configured to reflect light when no fluid is contacted and not reflect light when fluid is contacted. In this respect, ambient light enters the fiber optic cable 120 via the proximal end 120B and travels down the fiber optic cable 120 to its distal end 120A. If fluid is not present as the distal end 120A, the light is reflected back up the fiber optic cable 120, causing the proximal end 120B to be somewhat illuminated.
  • fluid e.g., CSF
  • the fluid reflecting functionality of the distal end 120A is achieved by including one or more angled surfaces on the distal end 120A.
  • the angled surfaces are angled such that the critical angle between the fiber optic material and air reflects light back but when contacting fluid (e.g., CSF), no reflection occurs.
  • the distal end 120A may have an angled cone shape, a pyramid shape, or a triangle shape created by two opposing facets. These surfaces are angled at about 45 degrees relative to an axis aligned with the length of the glass fiber of the fiber optic cable 120 (i.e., relatively to the direction of the fiber of the cable 120) or relative to the side surface of the fiber optic cable 120.
  • a surgeon first ensures that no water is located on the distal end 120A of the cable 120 (e.g., from an earlier unsuccessful attempt) by viewing it through aperture 1 16 and optionally cleaning the distal end 120A with a Q-tip or similar instrument.
  • the surgeon places the sensor 100 (e.g., the rigid tube 1 14 containing the fiber optic cable 120) into a drainage catheter 1 10.
  • a solid, rigid stylet rod is used to steer the flexible catheter into place.
  • the sensor 100 can alternately be used, as seen in Figure 4B. In other words, the sensor 100 is a type of stylet.
  • ambient light from the hospital room enters the proximal end of the fiber optic cable 120B, reflects off the distal end 120A (e.g., reflects off one 45 degree surface towards another area of 45 degree surface to ultimately change direction by 180 degrees), and causes the proximal end 120B to appear somewhat or completely illuminated, as seen in Figure 4A.
  • Figures 6-8 illustrate another embodiment of a fluid sensor 140 that is generally similar to the previously described sensor 100, but includes a second, reference fiber optic cable 146. Since the fiber optic cable 120 relies on ambient light from the hospital room to either reflect or pass through, the brightness of the proximal end 120B will similarly vary based on the level of ambient light. Rooms with lower levels of ambient light may result in reduced illumination of the proximal end 120B of the fiber optic cable 120 and therefore may make it difficult for a user to easily determine if the proximal end 120B is illuminated or not.
  • the reference fiber optic cable 146 includes a distal tip 146A that is angled to reflect light back up the cable 146.
  • the length of the cable 146 is relatively short, such that the distal end 146A is enclosed by two housing members 142 that form a proximal housing.
  • the distal end 146A always remains dry and therefore in an illuminated state (as long as there is ambient light in the room).
  • the user can compare the proximal end 120B of the cable 120 with the proximal end 146B of the reference cable 146. If the two have similar a similar brightness, fluid has not reached the distal end 120A of the cable 120. If the proximal end 120B is darker than the reference proximal end 146B, then fluid has likely reached the distal end 120A, indicating that the ventricle has been reached and punctured.
  • Both the cable 120 and cable 146 preferably include sleeves 144 that help position the cables 120, 146 (and tube 1 14) between the housing members 142.
  • These sleeves 144 can be composed of compressible material or relatively non-compressible material.
  • the fiber optic cable 120 is entirely located within said rigid tube 1 14. However, a portion of the cable's proximal end may exit the proximal end of the tube 1 14 and be disposed within a different structure, such as a flexible tube or the housing member 142.
  • Figure 9 illustrates a tube 1 14 with a second set of apertures 1 17 at a location closer to the distal end of the tube 1 14 than apertures 1 16.
  • the apertures 1 17 are located at about 0.25 inches from the distal end of the tube 1 14 while apertures 1 16 are located at about 0.60 inches from the distal end of the tube 1 14.
  • the tube 1 14 has an inner diameter of about 0.062 inches and an outer diameter of about 0.125 inches while the fiber optic cable 120 has an outer diameter of about 0.04 inches.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Psychology (AREA)
  • Neurosurgery (AREA)
  • Physiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Conformément à un mode de réalisation, l'invention porte sur un détecteur de fluide qui permet de détecter du liquide céphalorachidien (CSF) et d'aider un chirurgien à déterminer si un cathéter est ou non entré dans un ventricule du cerveau. Le détecteur de fluide comporte un indicateur, au niveau de l'extrémité proximale du dispositif, qui reste éclairé s'il n'y a pas d'humidité et qui s'assombrit lors d'un contact avec un fluide. Dans un mode de réalisation, le détecteur comprend un câble à fibres optiques présentant une extrémité distale qui est inclinée pour réfléchir la lumière de nouveau vers son extrémité proximale, tout en permettant à la lumière de passer en dehors de l'extrémité distale lorsque celle-ci est mouillée (par exemple telle que des surfaces à 45 degrés opposées au niveau de l'extrémité distale du câble à fibres optiques). Par conséquent, l'extrémité proximale du câble reste éclairée (lorsqu'elle est utilisée dans une pièce bien éclairée) et s'assombrit lorsque l'extrémité distale vient en contact avec un fluide, ce qui indique que le cathéter est passé dans un ventricule.
PCT/US2012/021758 2011-01-18 2012-01-18 Stylet détectant le liquide céphalorachidien (csf) WO2012099984A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161461326P 2011-01-18 2011-01-18
US61/461,326 2011-01-19

Publications (1)

Publication Number Publication Date
WO2012099984A1 true WO2012099984A1 (fr) 2012-07-26

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9895518B2 (en) 2006-10-09 2018-02-20 Neurofluidics, Inc. Cerebrospinal fluid purification system
US10632237B2 (en) 2006-10-09 2020-04-28 Minnetronix, Inc. Tangential flow filter system for the filtration of materials from biologic fluids
US10791990B2 (en) 2016-06-13 2020-10-06 Regents Of The University Of Minnesota Tissue detection system with a polymer needle
US10850235B2 (en) 2006-10-09 2020-12-01 Minnetronix, Inc. Method for filtering cerebrospinal fluid (CSF) including monitoring CSF flow
US11147540B2 (en) 2015-07-01 2021-10-19 Minnetronix, Inc. Introducer sheath and puncture tool for the introduction and placement of a catheter in tissue
US11577060B2 (en) 2015-12-04 2023-02-14 Minnetronix, Inc. Systems and methods for the conditioning of cerebrospinal fluid

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4809551A (en) * 1982-04-08 1989-03-07 S.T. Dupont Device for detecting the liquid level in a tank, particularly a lighter tank and tank provided with such device
US6210346B1 (en) * 1989-10-11 2001-04-03 Edwards Lifesciences Corp. Method for inserting an intracranial catheter and for monitoring intracranial pressure in a mammal
US20040036043A1 (en) * 2002-08-15 2004-02-26 Murshid Syed H. Fiber optic level detector
US20050236591A1 (en) * 2004-04-22 2005-10-27 Wirthlin Alvin R Optical transducer for detecting liquid level
US20080249467A1 (en) * 2007-04-05 2008-10-09 Daniel Rogers Burnett Device and Method for Safe Access to a Body Cavity

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4809551A (en) * 1982-04-08 1989-03-07 S.T. Dupont Device for detecting the liquid level in a tank, particularly a lighter tank and tank provided with such device
US6210346B1 (en) * 1989-10-11 2001-04-03 Edwards Lifesciences Corp. Method for inserting an intracranial catheter and for monitoring intracranial pressure in a mammal
US20040036043A1 (en) * 2002-08-15 2004-02-26 Murshid Syed H. Fiber optic level detector
US20050236591A1 (en) * 2004-04-22 2005-10-27 Wirthlin Alvin R Optical transducer for detecting liquid level
US20080249467A1 (en) * 2007-04-05 2008-10-09 Daniel Rogers Burnett Device and Method for Safe Access to a Body Cavity

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9895518B2 (en) 2006-10-09 2018-02-20 Neurofluidics, Inc. Cerebrospinal fluid purification system
US10398884B2 (en) 2006-10-09 2019-09-03 Neurofluidics, Inc. Cerebrospinal fluid purification system
US20200046954A1 (en) 2006-10-09 2020-02-13 Neurofluidics, Inc. Cerebrospinal fluid purification system
US10632237B2 (en) 2006-10-09 2020-04-28 Minnetronix, Inc. Tangential flow filter system for the filtration of materials from biologic fluids
US10850235B2 (en) 2006-10-09 2020-12-01 Minnetronix, Inc. Method for filtering cerebrospinal fluid (CSF) including monitoring CSF flow
US11065425B2 (en) 2006-10-09 2021-07-20 Neurofluidics, Inc. Cerebrospinal fluid purification system
US11529452B2 (en) 2006-10-09 2022-12-20 Minnetronix, Inc. Tangential flow filter system for the filtration of materials from biologic fluids
US11147540B2 (en) 2015-07-01 2021-10-19 Minnetronix, Inc. Introducer sheath and puncture tool for the introduction and placement of a catheter in tissue
US11577060B2 (en) 2015-12-04 2023-02-14 Minnetronix, Inc. Systems and methods for the conditioning of cerebrospinal fluid
US10791990B2 (en) 2016-06-13 2020-10-06 Regents Of The University Of Minnesota Tissue detection system with a polymer needle

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