WO2014145301A1 - Appareil et procédés d'accès au système lymphatique - Google Patents

Appareil et procédés d'accès au système lymphatique Download PDF

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Publication number
WO2014145301A1
WO2014145301A1 PCT/US2014/030039 US2014030039W WO2014145301A1 WO 2014145301 A1 WO2014145301 A1 WO 2014145301A1 US 2014030039 W US2014030039 W US 2014030039W WO 2014145301 A1 WO2014145301 A1 WO 2014145301A1
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WO
WIPO (PCT)
Prior art keywords
patient
fluid
thoracic duct
lymphatic fluid
lymphatic
Prior art date
Application number
PCT/US2014/030039
Other languages
English (en)
Inventor
Matthew John Callaghan
Stephen Arie Leeflang
Christian Scott Eversull
Original Assignee
Matthew John Callaghan
Stephen Arie Leeflang
Christian Scott Eversull
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 Matthew John Callaghan, Stephen Arie Leeflang, Christian Scott Eversull filed Critical Matthew John Callaghan
Publication of WO2014145301A1 publication Critical patent/WO2014145301A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607—Regulation parameters
    • A61M1/3609—Physical characteristics of the blood, e.g. haematocrit, urea
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3496—Plasmapheresis; Leucopheresis; Lymphopheresis
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • 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
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0405—Lymph

Definitions

  • Potential clinical applications may include drainage of lymphatic fluid for treatment of volume overload, for example, in the setting of congestive heart failure, depletion of lymphocytes or other immune system constituents, for example, in the setting of auto-immune disorders, preparation for transplantation procedures, treatment of infections residing primarily in immune-mediating cells, decompression of the lymphatic system to facilitate closure of leaking lymphatic vessels, treatment of lymphatic obstruction, and/or to otherwise remove fluid volume or pathologic constituents of lymphatic fluid.
  • Further clinical applications may include diagnosis and/or monitoring of malignancy or metastatic spread of malignant cells, or treatment of infection or malignancy, for example, by infusion of antibiotic, antiviral, antiparisitic, and/or chemotherapeutic agents directly into the lymphatic system.
  • Other applications may include removal and treatment or
  • a method for performing a medical procedure within a patient's body comprising a thoracic duct including an ostium communicating with the patient's venous system that includes introducing a distal portion of a tubular member through the patient's venous system into a body lumen adjacent the ostium of the thoracic duct, the distal portion biased to a curvilinear configuration; manipulating the tubular member until a distal tip of the distal portion enters the ostium of the thoracic duct; retracting the tubular member to direct the distal portion into the thoracic duct until an expandable member on the distal portion passes through a terminal valve of the thoracic duct; expanding the expandable member within the thoracic duct beyond the terminal valve to substantially isolate the thoracic duct from the body lumen; and performing a medical procedure via the thoracic duct.
  • a system and method for treating a patient via a thoracic duct of the patient's body that include providing a tubular member comprising a proximal end, a distal end sized for introduction into the patient's body, and an expandable member on the distal end; introducing the distal end of the tubular member into the patient's vasculature via a percutaneous access site with the expandable member in a contracted condition; advancing the tubular member until the distal end is disposed within a junction of the patient's left internal jugular vein and left subclavian vein; manipulating the tubular member to direct the distal end into the thoracic duct; expanding an expandable member on the distal portion adjacent the distal tip to substantially isolate the thoracic duct from the left internal jugular vein and left subclavian vein; removing lymphatic fluid from the thoracic duct through the tubular member to a location exterior to the patient's body;
  • FIGS. 2A and 2B are details of a distal portion of the apparatus of FIG. 1, showing a balloon on the distal portion in collapsed and enlarged configurations, respectively.
  • FIG. 4D is a detail of another alternative embodiment of a
  • a balloon or other expandable member 50 may be provided on the distal portion 30, e.g., sized for introduction into a thoracic duct in a collapsed configuration and expandable to an enlarged configuration for substantially sealing and/or isolating the thoracic duct 94, as described further below.
  • the balloon 50 may be formed from elastic material, e.g., such that the balloon 50 may be inflated to multiple diameters to
  • the distal portion 30 may be substantially shorter than the proximal portion 20, e.g., such that the proximal portion 20 may extend from a percutaneous access site (not shown) into the junction of the left internal jugular vein 92b and the left subclavian vein 92c, and the distal portion 30 may simply curve and enter the thoracic duct 94, as described further elsewhere herein.
  • the catheter 10 may include one or more lumens 26, 27 extending therethrough, e.g., from the proximal end 22 of the proximal portion 20 to the distal portion 30.
  • an aspiration or infusion lumen 26 may be provided that communicates with a port 23a in the handle 23 and extends through the entire proximal and distal portions 20, 30 to one or more inlet (or outlet) ports 36 adjacent the distal tip 35.
  • the aspiration lumen 26 may include a relatively large region 26a within the proximal portion 20 and a relatively small region 26b within the distal portion 30.
  • the catheter 10 may include an inflation lumen 27, e.g., extending through the proximal and distal portions 20, 30 and
  • the catheter 10 may be retracted or otherwise manipulated to direct the distal portion 30 further into the thoracic duct 94.
  • the catheter 10 may be introduced into the left internal jugular vein 92b, as shown in FIG. 5, the length of the catheter 10 may be substantially shorter than most catheters, thereby providing a more direct relationship of movement between the proximal end 22 and the distal portion 30 since the catheter 10 is less likely to twist, compress, stretch, and the like between the proximal end 22 and the distal portion 30.
  • fluid may be aspirated into the lumen 26 of the catheter 10 and collected, e.g., as described elsewhere herein, fluid may be delivered into the thoracic duct 94, and/or other desired procedures may be performed via the thoracic duct 94.
  • the catheter 10' may include a movable distal tip 35,' which may be directed axially closer to or away from the balloon 50.
  • the balloon 50' may be attached to the distal end of an outer tubular member 30,' and an inner tubular member 37' may extend through the outer tubular member 30' and the balloon 50,' and terminate in the distal tip 35.
  • movement of the inner tubular member 37' relative to the outer tubular member 30' may move the distal tip 35' relative to the balloon 50.
  • the balloon 50' may serve to substantially center the distal tip 35' relative to the valve(s) 95 within the thoracic duct 94 (not shown in FIG. 4D), e.g., such that the distal tip 35' may be advanced or retracted as desired relative to the valve(s) 95 to facilitate access, removal of fluid, and/or performing other procedures within the thoracic duct 94.
  • the balloons 150 may be slidably disposed relative to one another (not shown) such that they may be brought together or moved apart, e.g., to capture and/or release a valve positioned between them.
  • one or more balloons may include different surface properties, e.g. a lubricious distal surface (e.g., using a hydrophilic coating, lubrication, surface features, and the like), e.g., to facilitate valve crossing and a less lubricious proximal surface to, e.g. to decrease the chance of inadvertent removal.
  • exemplary features may be provided on the catheter, e.g., in addition to or instead of the tines 254 to maintain the distal end of the catheter 210 (or any of the embodiments herein) in a desired position, e.g., within the thoracic duct.
  • Exemplary features may include providing silicone or other anti-slip materials on the distal end, a Nitinol or other expandable anchoring structure, an anchor ring, and the like (not shown).
  • the size of the frame 450 may be sufficient to engage the ostium adjacent the thoracic duct, or may be sized for introduction into the thoracic duct such that the membrane 454 sealingly engages the wall of the thoracic duct, e.g., when the distal portion 430 is introduced into the thoracic duct on either side of one or more valves, similar to other embodiments herein.
  • one or more external devices may be provided that are coupled to the proximal end 22 of the catheter 10, e.g., for detecting, separating, collecting, and/or infusing lymphatic fluid and/or other fluids, as described in U.S. Publication No. 2011/ 0276023.
  • the external components may be provided integrated into a single device or may be provided as separate discrete components that are coupled to one another (e.g., along a fluid path, electrically, and/or otherwise).
  • the external components include a detector or analyzer 60, a controller 62, a separator 64, a waste container 66, a storage container 68, and an infusion device 70.
  • One or more of the components may include a pump or source of vacuum or pressure, e.g., for removing fluid from the patient's body and/or delivering fluid into the patient's body 90 via the catheter 10, or infusing fluids via the infusion device 70, as described further below.
  • one or more of the components may be omitted.
  • the catheter 10 may simply be coupled directly to the storage container 68, e.g., with or without a source of vacuum to facilitate collection of lymphatic fluid.
  • the sensor(s) may include one or more optical sensors (e.g., for detecting the presence of red blood cells by light transmission or reflection characteristics), chemical sensors (e.g., for detecting one or more of pH, oxygen concentration, lactate, leukocyte esterase, and the like), sensors for measuring hematocrit, electrical sensors (e.g., for measuring impedance), temperature sensors, mechanical sensors (e.g., for detecting pressure waves, which may differ between the venous system and the thoracic duct; for flow detection, e.g., by Doppler ultrasound), filter devices sized to constituents of whole blood, and the like.
  • optical sensors e.g., for detecting the presence of red blood cells by light transmission or reflection characteristics
  • chemical sensors e.g., for detecting one or more of pH, oxygen concentration, lactate, leukocyte esterase, and the like
  • sensors for measuring hematocrit e.g., for measuring impedance
  • temperature sensors e.g., for measuring impedance
  • the separator 64 may include one or more devices for separating various components of lymphatic fluid, including various types of cells, proteins, electrolytes, water, and/or other constituent parts of lymphatic fluid.
  • water may be substantially separated from other components in order to selectively remove excess water from a patient.
  • pathologic cells may be selectively separated from other constituents in order to remove pathologic cells from a patient.
  • a filter (not shown) may be provided within the detector 60 or separator 64, which may clog in the presence of a predetermined number or concentration of cells, e.g., red blood cells, to prevent the fluid from being delivered into the storage container 68.
  • coagulation/clotting may be used to prevent flow in the presence of whole blood and its constituents (for example, platelets).
  • a passage through the detector 60 or other external component may be sized to clot spontaneously, a filter may be used where clotting decreases flow, and/or pro-coagulant materials may be used to augment or accelerate a clotting response.
  • the component of the system 6 designed to prevent flow may be cleanable and/or replaceable, e.g., to allow to resumption of flow after isolation of the thoracic duct 94 is reestablished.
  • the aspiration lumen may include an inlet distally beyond the balloon, e.g., for aspirating fluid from the isolated thoracic duct, while the infusion lumen may include an outlet proximal to the balloon, e.g., to provide a fluid channel into the venous system adjacent to the thoracic duct.
  • the catheter 10 may include a working lumen sized for receiving auxiliary devices therethrough (not shown), e.g., larger than the infusion lumen(s) for receiving one or more guidewires, auxiliary catheters, and the like (not shown). If the catheter 10 includes one or more balloons, e.g., balloon 50 shown in FIG.
  • the catheter 10 may also include one or more inflation lumens (not shown), e.g., adjacent the aspiration, infusion, and/or working lumen(s), for inflating and/or collapsing the balloon(s) together or independently of one another, as described elsewhere herein.
  • inflation lumens not shown
  • the balloon(s) may also include one or more inflation lumens (not shown), e.g., adjacent the aspiration, infusion, and/or working lumen(s), for inflating and/or collapsing the balloon(s) together or independently of one another, as described elsewhere herein.
  • lymphatic fluid may be used to perform a variety of procedures within the patient's body, e.g., to diagnose and/or treat a variety of conditions.
  • lymphatic fluid drains interstitial fluid from the patient's body
  • removal of lymphatic fluid may facilitate reduction of interstitial fluid volume without significant alterations in circulating blood volume of the patient.
  • lymphatic fluid contains a much higher concentration of various components (e.g., immune cells, proteins, lipids, externalized RNA (e.g., exosomes), and the like) than are contained in circulating blood.
  • the relative ease of access to these components at relatively higher concentrations directly in lymphatic fluid may be useful in diagnosing and treating certain medical conditions.
  • cell populations, their level of maturity and/or activation, their cell surface markers or other distinguishing features in the lymph may be assayed to diagnose various disease or normal physiologic states, including those discussed below.
  • a patient suffering from sepsis may be diagnosed and/or treated using any of the catheters and/or methods described herein.
  • Sepsis is inflammation throughout a patient's body, e.g., due to severe infection.
  • lymphatic fluid may be removed from the patient's body via a catheter accessing the thoracic duct, treated, and then at least partially returned to the patient's body, e.g., via the catheter 10 back into the thoracic duct or elsewhere in the patient's vasculature.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne des systèmes et procédés pour effectuer une procédure médicale à l'intérieur du corps d'un patient qui implique un canal thoracique comprenant un ostium communiquant avec le système veineux du patient. Une extrémité distale d'un cathéter est introduite à travers le système veineux du patient dans une lumière corporelle adjacente à l'ostium du canal thoracique. Un élément expansible sur l'extrémité distale de l'élément tubulaire peut être élargi de manière adjacente à l'ostium, par exemple, à l'intérieur de la lumière corporelle ou du canal thoracique lui-même, et utilisé pour isoler le canal thoracique de la lumière corporelle, après quoi une procédure médicale peut être effectuée par l'intermédiaire du canal thoracique. Par exemple, du liquide lymphatique peut être retiré du canal thoracique à travers une lumière de l'élément tubulaire et/ou un ou plusieurs agents peuvent être introduits dans le canal thoracique à travers l'élément tubulaire.
PCT/US2014/030039 2013-03-15 2014-03-15 Appareil et procédés d'accès au système lymphatique WO2014145301A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361800161P 2013-03-15 2013-03-15
US61/800,161 2013-03-15
US201361804099P 2013-03-21 2013-03-21
US61/804,099 2013-03-21

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2844331A4 (fr) * 2012-05-03 2016-01-20 Christian Scott Eversull Appareil et méthodes d'accès au système lymphatique

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989004193A1 (fr) * 1987-11-06 1989-05-18 Francis William Arnold Dispositif utilise dans le traitement de lymphocytes
US4957484A (en) * 1988-07-26 1990-09-18 Automedix Sciences, Inc. Lymph access catheters and methods of administration
US5980479A (en) * 1997-07-02 1999-11-09 Idializa Ltd. Method and system for correcting a biological fluid
US20070282382A1 (en) * 2006-06-06 2007-12-06 Shuros Allan C Method and device for lymphatic system monitoring
US20110276023A1 (en) * 2010-05-04 2011-11-10 Leeflang Stephen A Apparatus and Methods for Accessing the Lymphatic System
US20120029466A1 (en) * 2009-01-12 2012-02-02 The Board Of Trustees Of The Leland Stanford Junior University Drainage devices and methods for use

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1989004193A1 (fr) * 1987-11-06 1989-05-18 Francis William Arnold Dispositif utilise dans le traitement de lymphocytes
US4957484A (en) * 1988-07-26 1990-09-18 Automedix Sciences, Inc. Lymph access catheters and methods of administration
US5980479A (en) * 1997-07-02 1999-11-09 Idializa Ltd. Method and system for correcting a biological fluid
US20070282382A1 (en) * 2006-06-06 2007-12-06 Shuros Allan C Method and device for lymphatic system monitoring
US20120029466A1 (en) * 2009-01-12 2012-02-02 The Board Of Trustees Of The Leland Stanford Junior University Drainage devices and methods for use
US20110276023A1 (en) * 2010-05-04 2011-11-10 Leeflang Stephen A Apparatus and Methods for Accessing the Lymphatic System

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2844331A4 (fr) * 2012-05-03 2016-01-20 Christian Scott Eversull Appareil et méthodes d'accès au système lymphatique

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