WO2024097946A1 - Systèmes et procédés de manipulation de propriétés corporelles à l'aide d'un cathéter d'échange de fluide - Google Patents

Systèmes et procédés de manipulation de propriétés corporelles à l'aide d'un cathéter d'échange de fluide Download PDF

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Publication number
WO2024097946A1
WO2024097946A1 PCT/US2023/078617 US2023078617W WO2024097946A1 WO 2024097946 A1 WO2024097946 A1 WO 2024097946A1 US 2023078617 W US2023078617 W US 2023078617W WO 2024097946 A1 WO2024097946 A1 WO 2024097946A1
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WO
WIPO (PCT)
Prior art keywords
fluid
temperature
infusion
body cavity
catheter
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Application number
PCT/US2023/078617
Other languages
English (en)
Inventor
Behnam Rezai JAHROMI
David Robbins Asbury
Mark Mallaby
Adam Sampson
John Unser
Original Assignee
Irras Usa, 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.)
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Publication date
Application filed by Irras Usa, Inc. filed Critical Irras Usa, Inc.
Publication of WO2024097946A1 publication Critical patent/WO2024097946A1/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
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling

Definitions

  • the present disclosure relates generally to methods and systems for manipulating a body property or biomarker, such as temperature or pH, using a fluid exchange catheter system.
  • TH therapeutic hypothermia
  • SBC selective brain cooling
  • Acute brain damage may lead to distal organ damage even in the absence of systemic disease or inflammation. Since this type of injury affects not only the brain but also the whole body, a holistic therapeutic approach may be required. Although systemic TH can help alleviate this type of brain damage, it can cause systemic complications that affect biological survival processes. Induction and maintenance of systemic hypothermia in homeothermic mammals causes physiological side effects, and some side effects may lead to morbidity and death. The side effects of TH can be systemically classified into cardiac, immunologic, and metabolic complications. Common adverse events of TH may include hyperglycemia, shivering, bradycardia, electrolyte abnormalities, acute kidney injury, pneumonia, and hypercoagulability or hypocoagulability syndrome.
  • thermoreceptor-targeted drugs may be an effective strategy for stroke treatment in conscious subjects, even when initiated after a significant period following reperfusion. Combination therapy of pharmacological and physical TH methods may effectively reduce side effects by decreasing the drug dosage and the time required to reach the therapeutic target.
  • SBC can be performed in three approaches to reach the target temperature in patients with acute brain injury.
  • the three main mechanisms of SBC are as follows: (1) direct surface cooling of the scalp; (2) intravascular cooling that enables heat exchange between the internal carotid artery and intracranial venous drainage; and (3) intranasal cooling that enables rapid heat exchange in the upper airway.
  • the present disclosure provides a method for selectively changing a temperature of a body cavity from a baseline temperature to a target temperature that is different than the baseline temperature.
  • the method includes activating an infusion mechanism to infuse a fluid through a first fluid path and an infusion lumen in a catheter component to the body cavity for an infusion time period.
  • the fluid is brought to a target fluid temperature prior to reaching the body cavity.
  • the method also includes periodically or continuously removing at least a portion of the fluid through a second fluid path, monitoring a temperature of the body cavity, and maintaining the target temperature for a predetermined time period.
  • the present disclosure provides a system for modifying a temperature of a body cavity.
  • the system includes a catheter system comprising a fluid set and a catheter component adapted for insertion into the body cavity.
  • the system further includes a fluid source comprising a fluid, an infusion mechanism comprising a pump adapted to pump the fluid from the fluid source to the catheter component, a drainage line adapted for removing at least a portion of the fluid, one or more temperature sensors adapted to measure a temperature in the body cavity, and a heat exchange unit adapted to heat or cool the fluid prior to reaching the body cavity.
  • the present disclosure provides a method of manipulating a state of one or more physiological biomarkers within a target area of a body cavity using a fluid exchange catheter system.
  • the fluid exchange catheter system includes a catheter component with a plurality of fluid paths.
  • a first fluid path is formed by a first lumen having a proximal end, a distal end, and a lumen wall extending between the proximal end and the distal end.
  • a second fluid path is formed by a second lumen having a proximal end, a distal end, and a lumen wall extending between the proximal end and the distal end.
  • the system also includes an aspiration mechanism operably connected to the proximal end of the first lumen and an infusion mechanism operably connected to the proximal end of the second lumen.
  • the method includes (a) activating the infusion mechanism to infuse an infusion fluid through the first fluid path and to the target area of the body cavity of a patient for an infusion time period or volume while the aspiration mechanism is disabled, (b) disabling the infusion mechanism to stop infusion, (c) activating the aspiration mechanism to aspirate fluid from the target area of the patient through the second fluid path for an aspiration time period or volume while the infusion mechanism is disabled, (d) disabling the aspiration mechanism to stop aspiration, and (e) repeating steps (a) through (d). Steps (a) through (d) need not be performed in any particular order.
  • a method for selectively changing a temperature of a body cavity from a baseline temperature to a target temperature that is different than the baseline temperature comprising: (a) activating an infusion mechanism to infuse a fluid through a first fluid path and an infusion lumen in a catheter component to the body cavity for an infusion time period, wherein the fluid is brought to a target fluid temperature prior to reaching the body cavity; (b) periodically or continuously removing at least a portion of the fluid through a second fluid path; (c) monitoring a temperature of the body cavity; and (d) maintaining the target temperature for a predetermined time period.
  • Clause 3 The method of clause 1 or 2, wherein the fluid is a cooling fluid and is brought to the target fluid temperature using a cooling unit selected from the group consisting of: one or more ice packs, one or more ice baths, a freezer, and a refrigerator.
  • a cooling unit selected from the group consisting of: one or more ice packs, one or more ice baths, a freezer, and a refrigerator.
  • Clause 7 The method of any of clauses 1-6, wherein the predetermined time period is between 24 and 72 hours.
  • Clause 8 The method of any of clauses 1-7, wherein the second fluid path is a drainage line disposed in a spinal column.
  • Clause 10 The method of any of clauses 1-9, wherein the second fluid path is an aspiration lumen in the catheter.
  • Clause 11 The method of any of clauses 1-10, wherein the catheter component is a dual lumen catheter or a duplicity of single lumen catheters.
  • Clause 12 The method of any of clauses 1-11, further comprising gradually returning the body cavity to a temperature within 1 to 2°C of the baseline temperature.
  • Clause 13 The method of clause 12, wherein gradually returning the body cavity to the temperature within 1 to 2°C of the baseline temperature comprises raising the temperature of the body cavity by 0.05°C to 0.2°C per hour.
  • Clause 14 The method of any of clauses 1-13, wherein the fluid has a composition that is substantially equivalent to the composition of cerebrospinal fluid.
  • Clause 15 The method of any of clauses 1-14, wherein the fluid is a lactated ringer or saline fluid.
  • Clause 16 The method of any of clauses 1-15, wherein the fluid comprises one or more anti-inflammatory drugs.
  • Clause 17 The method of any of clauses 1-16, further comprising providing a visual or audio indicator if the monitored temperature differs from the target temperature by a threshold amount.
  • Clause 18 The method of any of clauses 1-17, wherein the method is performed on a patient suffering from neuro-inflammation.
  • Clause 19 The method of any of clauses 1-18, wherein the method is performed on a patient at risk of neuronal necrosis and/or ischemic brain damage.
  • a system for modifying a temperature of a body cavity comprising: a catheter system comprising a fluid set and a catheter component adapted for insertion into the body cavity; a fluid source comprising a fluid; an infusion mechanism comprising a pump adapted to pump the fluid from the fluid source to the catheter component; a drainage line adapted for removing at least a portion of the fluid; one or more temperature sensors adapted to measure a temperature in the body cavity; and a heat exchange unit adapted to heat or cool the fluid prior to reaching the body cavity.
  • Clause 21 The system of clause 20, wherein the drainage line is a spinal drainage line adapted for insertion into a spine of a patient.
  • Clause 22 The system of clause 20 or 21, wherein the heat exchange unit is a cooling unit selected from a group consisting of: one or more ice packs, one or more ice baths, a freezer, and a refrigerator.
  • the heat exchange unit is a cooling unit selected from a group consisting of: one or more ice packs, one or more ice baths, a freezer, and a refrigerator.
  • Clause 23 The system of any of clauses 20-22, wherein the catheter component is a dual lumen catheter or a duplicity of single lumen catheters.
  • Clause 24 A method of manipulating a state of one or more physiological biomarkers within a target area of a body cavity using a fluid exchange catheter system, wherein the fluid exchange catheter system comprises: a catheter component comprising a plurality of fluid paths, wherein a first fluid path is formed by a first lumen having a proximal end, a distal end, and a lumen wall extending between the proximal end and the distal end, and wherein a second fluid path is formed by a second lumen having a proximal end, a distal end, and a lumen wall extending between the proximal end and the distal end; an aspiration mechanism operably connected to the proximal end of the first lumen; and an infusion mechanism operably connected to the proximal end of the second lumen, the method
  • Clause 27 The method of any of clauses 24-26, wherein the catheter component is a dual lumen catheter or a duplicity of single lumen catheters.
  • Clause 28 The method of any of clauses 24-27, wherein the one or more physiological biomarkers include temperature, intracranial pressure, pH, oxygen, sodium, glucose, creatinine, carbon dioxide, chlorine, proteins, or similar attributes in blood or cerebrospinal fluid chemistry, and combinations thereof.
  • Clause 29 The method of any of clauses 24-28, wherein the infusion fluid is selected from a group consisting of: saline, lactated ringers, or other physician prescribed fluids.
  • Clause 30 The method of any of clauses 24-29, further comprising: infusing a drug into the body cavity through the one or more of the fluid paths.
  • Clause 32 The method of clause 30, wherein the drug is selected from a group consisting of: thrombolytic s, antibiotics, or other physician prescribed drugs for infusion, or combinations thereof.
  • Clause 33 The method of any of clauses 24-32, wherein the body cavity is a brain.
  • Clause 34 The method of clause 33, wherein the infusion fluid is infused into a ventricular system in the brain.
  • Clause 35 The method of any of clauses 24-34, wherein steps (a) through (d) are repeated until the temperature, pH, and/or other relevant biomarkers within the target area of the body cavity is at a target level.
  • Clause 36 The method of any of clauses 24-35, wherein the patient is suffering from neuro-inflammation.
  • Clause 37 The method of any of clauses 24-36, wherein the patient is at risk of neuronal necrosis and/or ischemic brain damage.
  • Clause 38 The method of any of clauses 24-37, wherein steps (a) through (d) are repeated until inflammation is reduced by a clinically valid amount.
  • FIG. 1 is a perspective view of a fluid exchange system according to an aspect of the present disclosure
  • FIG. 2 is a left perspective view of a control unit of the fluid exchange system of FIG. 1;
  • FIG. 3 is a right perspective view of the control unit of FIG. 2;
  • FIG. 4 is a rear view of the control unit of FIG. 2;
  • FIG. 5 is a front view of a tube set attachment of the fluid exchange system of FIG. 1;
  • FIG. 6 is a schematic diagram of the operating system of the fluid exchange system of FIG. 1;
  • FIG. 7 is a perspective view of a catheter according to one aspect of the present disclosure.
  • FIG. 8 is a cross-sectional view of the catheter of FIG. 7;
  • FIG. 9 is a cross-sectional view of a distal tip of the catheter of FIG. 7 taken along line A-A;
  • FIG. 10 is a perspective view of a distal tip of a catheter according to an aspect of the present disclosure.
  • FIG. 11 is a perspective view of a configuration using a spinal drainage line according to an aspect of the present disclosure.
  • physiological biomarkers that can be manipulated using the fluid exchange catheter system include: temperature, pressure (e.g., intracranial pressure), pH, oxygen, sodium, glucose, creatinine, carbon dioxide, chlorine, proteins, or similar attributes in blood or cerebrospinal fluid chemistry, and combinations thereof.
  • the methods and systems disclosed herein can use a fluid exchange catheter system to deliver and remove (e.g., drain) one or more fluids from a target area in order to manipulate the one or more properties.
  • the fluid exchange catheter system can deliver a cooling fluid to the central nervous system (“CNS”) or portions thereof (e.g., brain or spinal column/cord) in order to modify (e.g., lower or increase) the temperature thereof.
  • CNS central nervous system
  • the fluid exchange catheter system can also remove, such as by draining, fluid from the CNS, such as spent cooling fluid and/or cerebrospinal fluid (“CSF”) of the patient. The removal can ensure that additional fluid can be added without increasing the pressure.
  • CNS central nervous system
  • CSF cerebrospinal fluid
  • the methods and systems described herein can achieve targeted cooling of the brain and/or CNS without subjecting other portions of the body (e.g., other organs, such as the heart or lungs) to the same cooling effect, or at least not subjecting these other portions of the body to the same extent of cooling.
  • Reduction of the temperature in the brain or other body portion can provide various advantages, including reduction of oedema (stretching of tissue and allowing it stay intact in structure) and reduction in the tissue metabolism and inflammation that may be caused by trauma (mechanical disruption) or ischemia (lack of oxygen).
  • selective or targeted cooling of the target area provides added benefits in that it can avoid whole body hypothermia and the issues that may arise from cooling the heart, lungs, arteries, and other body portions.
  • the system 2 includes a control unit 4 connected to an intravenous (“IV”) pole 6 or other support structure, a tube set attachment 8, a fluid source 10, and a drainage receptacle 12.
  • the control unit 4, the drainage receptacle 12, and the fluid source 10 may be connected to the IV pole 6 using any suitable connection means for securing the control unit 4 and the drainage receptacle 12 to the IV pole 6.
  • the fluid source 10 and the drainage receptacle 12 are fluidly connected to the tube set attachment 8.
  • the fluid source 10 is an infusion bag.
  • the drainage receptacle 12 is an aspiration bag.
  • the fluid source 10 can be positioned above the tube set attachment 8 and directs fluid into the tube set attachment 8.
  • the drainage receptacle 12 can be positioned beneath the tube set attachment 8 and receives fluid drained from the patient and through the tube set attachment 8.
  • the system 2 also includes a tube set 36 and cooling unit 88, which will be described below.
  • control unit 4 of the system 2 is shown and described in greater detail.
  • the control unit 4 may be a computer-based management system that utilizes, for example, software and/or firmware to enable pump and sensor control and appropriate delivery of fluid.
  • the software and/or firmware can include algorithms in the form of programming instructions stored in non-transitory, machine-readable media associated with the system 2.
  • the programming instructions can be executed by a processor associated with the control unit 4 to enable the control unit 4 to perform the various tasks and methods discussed herein.
  • the control unit 4 can include a pump 66 that is configured to direct fluid through the tube set attachment 8.
  • the pump 66 can be configured to direct fluid from the fluid source 10 through the tube set attachment 8 to a patient.
  • the pump 66 can also be configured to drain fluid from the patient through the tube set attachment 8 and into the drainage receptacle 12 by generating or creating a negative pressure in the tube set attachment 8.
  • Pumps suitable for use in this disclosure are generally known.
  • the pump 66 is a peristaltic pump.
  • the control unit 4 may also include a pinch valve to control the flow of fluid through the tube set attachment 8.
  • the pump 66 and pinch valve can be held within a housing 14 of the control unit 4.
  • the control unit 4 also can include a connection port 16 to receive the tube set attachment 8.
  • the control unit 4 can further include a graphical user interface (“GUI”) 18 to display control options, alarm indications, and system parameters regarding the system 2 to a patient or medical personnel.
  • GUI 18 includes an LCD touchscreen display to permit medical personnel to operate the control unit 4.
  • the control unit 4 also includes a central processing unit (“CPU”) that is configured to operate the pump 66 housed within the control unit 4. The CPU can also communicate with sensors provided in the system 2 to measure and record system operating parameters and alarm indications for the control unit 4.
  • CPU central processing unit
  • the system 2 may also include flow sensors, algorithms, and related methods for controlling pump motor function, for example, to achieve precise control of infusions, both in volume, rate, duration, post infusion pause period, and pressure measurement intervals in order to deliver fluids, pharmaceutical agents, alter tissue effect and response, achieve the desired therapeutic effect, meet safety requirements, manage unclogging of a catheter 44, and tube set 36, and achieve desired flow properties.
  • Flow sensors may be MEMS-based flow sensors or impeller driven flow meters, for example.
  • control unit 4 can also include a drainage receptacle hanger 32 configured to hold the drainage receptacle 12.
  • the drainage receptacle 12 is an aspiration bag.
  • the drainage receptacle hanger 32 may include a graduated measuring band 34 connected at one end to the control unit 4 and at an opposing end to the drainage receptacle 12.
  • the graduated measuring band 34 permits the drainage receptacle 12 to be vertically adjusted relative to the control unit 4.
  • the graduated measuring band 34 can also indicate the vertical distance between the control unit 4 and the drainage receptacle 12.
  • the graduated measuring band 34 includes measurements provided thereon (such as inches, centimeters, etc.) that identify a vertical distance between the drainage receptacle 12 and the control unit 4.
  • the control unit 4 can be in communication with various data sources, including a keypad and/or touchscreen 46 of the GUI 18, the pressure sensor calibration knob 42, a real-time clock calendar 48, a flash memory 50, a USB host 52, and a service port 54.
  • the control unit 4 is also in communication with at least one pressure sensor 56 configured to record measurements of fluid pressure in the system 2.
  • a pressure sensor 56 may be positioned on at least one of the following: the control unit 4, the tube set attachment 8, and the catheter 44.
  • one or more temperature sensors 76, 78 may be positioned on at least one of the following: the tube set attachment 8, the tube set 36, and the catheter 44.
  • the control unit 4 is also in communication with a safety module 58.
  • the control unit 4 may handle patient treatment, GUI 18 processing, data logging, and external communication.
  • the safety module 58 may monitor the control unit 4 to ensure the control unit 4 is functioning as intended.
  • the safety module 58 may be provided remotely from the control unit 4.
  • the safety module 58 may also be in communication with a pressure sensor 60 provided on at least one of: the control unit 4, the tube set attachment 8, the tube set 36, and the catheter 44.
  • the control unit 4 and the safety module 58 are both in communication with an audible alarm 62, the pinch valve 64, the pump 66, the air sensor 30, and a main battery 68 that provides power to the control unit 4 and the safety module 58.
  • the treatment process performed by the system 2 may include the use of a drug or drug combination.
  • the drug or drug combination is administered to a patient by the catheter 44 or the system 2 of the present disclosure.
  • a drug combination includes at least two drugs.
  • a fluid administered by the system 2 is a physiological fluid. That is, physiological fluids (which are generally not limited, and are well-known to the skilled person), such as NaCl 0.9% or ringer’s lactate fluid, may be administered (and optionally aspirated) by a catheter 44 of the disclosure.
  • the fluid is a nutrient fluid.
  • the system 2 can manage the flow of infused and aspirated fluids through the catheter 44, which may be a multi-lumen catheter or a duplicity of single lumen catheters.
  • the control unit 4 is a software-based management system using certain algorithms to enable pump and sensor control and appropriate delivery of the fluid. Infusion and aspiration flow management can be performed by a valve function capable of alternately restricting and permitting fluid flow, and therefore, fluid pressure to the tubing, catheter, distal lumen, distal ports, targeted tissues, and body cavity.
  • a valve can be used to manage aspirated fluid, while infused fluid is managed by pump function.
  • the valve function is steered by the control unit 4 according to the algorithm and desired therapy, in which the protocol performed by the controller, pump, and valve includes a programmed, alternating series of infusion, aspiration, and pauses, in any therapy-appropriate combination thereof.
  • the control unit 4 operates the pump 66 and valve to determine flow rate, fluid pressures within the system, and body cavity pressures.
  • the valve is constructed in a manner to both act on the tube set 32 as a pinch valve 64 and to allow insertion, threading, or feeding of the tube set 32 into the control unit 4 and through the valve.
  • the valve itself is constructed to function as a pinch valve 64 through axial displacement against the tubing, for example, as a linear solenoid.
  • the valve may also be constructed as a cantilever mechanism, roller mechanism, wedge, or tubing deflection mechanism.
  • the programmed treatment state can be used to infuse and/or aspirate a fluid to and from a body cavity.
  • the control unit 4 can sequence through different treatment parameters selected by the user to move between different infusion and aspiration states.
  • the control unit 4 is configured to supply and direct fluid from the fluid source 10, through the tube set 36, and to the patient, such as to the patient’s intracranial cavity.
  • the control unit 4 is configured to drain fluid from, for example, the intracranial cavity through the tube set 36 and into the drainage receptacle 12.
  • the pump 66 of the control unit 4 can create positive pressure in the tube set 36 or a particular lumen thereof to pump fluid to the patient during the infusion states, and can create negative pressure in the tube set 36 or a particular lumen thereof to drain fluid from the patient during the aspiration states.
  • Exemplary infusion and aspiration programs include those discussed in United States Patent No. 8,398,581 and United States Patent Application Publication No. 2015/0224284, the disclosures of which are incorporated herein by reference.
  • the control unit 4 may be preprogrammed to switch between the infusion and aspiration states based on desired results from the medical personnel.
  • the control unit 4 may switch between the infusion and aspiration states based on pressure readings recorded by the pressure sensors 56, 60.
  • the pressure sensors 56, 60 may send intracranial pressure (“ICP”) readings to the control unit 4, which monitors the ICP levels of the patient.
  • ICP intracranial pressure
  • the control unit 4 continues to run the preprogrammed treatment process.
  • the control unit 4 may be configured to initiate the aspiration state to drain fluid from the patient’s intracranial cavity to reduce the ICP.
  • control unit 4 may be configured to resume the preprogrammed treatment process.
  • the control unit 4 may be configured to initiate the infusion state to direct additional fluid to the patient’s intracranial cavity. After the fluid has been directed to the intracranial cavity and the ICP readings increase above the low ICP level setting, the control unit 4 may be configured to resume the preprogrammed treatment process.
  • a treatment stop event for the control unit 4 will return the system 2 to the ready state. The treatment stop event may be initiated by the medical personnel pressing a start/stop button. It is also contemplated that the control unit 4 may be automatically returned to the ready state in the event an emergency situation occurs with the control unit 4 and/or patient.
  • the control unit 4 may move between the infusion and aspiration states using several different techniques.
  • the pressure sensors 56, 60 may measure a first pressure value in the intracranial cavity and send this measurement to the control unit 4. An infusion of fluid into the intracranial cavity may then be initiated by the control unit 4. After the infusion state, the pressure sensors 56, 60 may measure a second pressure value in the intracranial cavity and send this measurement to the control unit 4.
  • the CPU of the control unit 4 may then compute or determine a difference between the first and second pressure readings from the pressure sensors 56, 60. In the event the difference between the first and second pressures exceeds a high threshold level, the control unit 4 may issue a high pressure signal output.
  • the control unit 4 may then initiate an aspiration state to reduce the ICP. In the event the difference between the first and second pressures is below a low threshold level, the control unit 4 may issue a low pressure signal output. The control unit 4 may then initiate an infusion state to increase the ICP.
  • Example fluid exchange catheter systems that can be used to perform the methods disclosed herein are those disclosed in one or more of United States Patent Nos. 8,398,581, 9,623,177, 10,293,105, and 11,123,483, the entire contents of each of which are herein incorporated by reference.
  • Other examples of fluid exchange catheter systems that can be used to perform the methods disclosed herein are those disclosed in United States Patent Application Publication No. 2020/0237977, the entire contents of which are herein incorporated by reference.
  • Another example of a fluid exchange catheter system that can be used to perform the methods disclosed herein is the IRRAflow® Active Fluid Exchange System (AFES) provided by IRRAS.
  • the AFES is an intracranial fluid exchange system intended for use by medical hospital personnel, such as in neurosurgical medical care.
  • catheter component that can be used in the systems and methods described herein is any multilumen catheter including more than one lumen, wherein one lumen is configured as an aspiration lumen and the second lumen is configured as an infusion lumen.
  • catheter component may be a combination of two or more separate catheters, a first of which is configured as an aspiration/drainage catheter and a second of which is configured as an infusion catheter.
  • the aspiration/drainage catheter may be configured to drain from a distal end of the body cavity and the infusion catheter may be configured to infuse through the proximal (opposite) end of the body cavity.
  • the catheter 44 may include a variety of features that focus on achieving the desired infusion and aspiration functions of the system 2. Several of these features are shown and described in U.S. Patent Application Publication No. 2015/0224284, the disclosure of which is hereby incorporated in its entirety by reference.
  • the tip of a catheter 44 that is inserted in biological material, e.g. the patient’s body is called the distal tip or distal end of the catheter 44 and the tip that stays outside of the biological material is called the proximal tip or proximal end of the catheter 44.
  • the catheter 44 may be a dual lumen catheter.
  • the catheter 44 may include an infusion lumen 104 and an aspiration lumen 106 that are each created by one or more lumen walls that extend generally from a proximal end to a distal tip 108 of the catheter 44.
  • the specific lumina may be switched, i.e., the infusion lumen 104 and the aspiration lumen 106.
  • the infusion lumen 104 may act as the outer catheter body.
  • the infusion and aspiration lumina 104, 106 branch off from one another at an intermediate position on the catheter 44.
  • the aspiration lumen 106 may be defined in the infusion lumen 104 along the length of the catheter 44 in which the infusion and aspiration lumina 104, 106 converge.
  • infusion fluid from the fluid source 10 is directed through the infusion lumen 104.
  • fluid aspirated from the intracranial cavity to the drainage receptacle 12 is directed through the aspiration lumen 106.
  • the infusion lumen 104 and aspiration lumen 106 are each structurally configured to allow for infusion or aspiration to occur therein, depending on the particular direction of flow enabled by the device attached at a proximal end thereof.
  • the distal tip 108 of the catheter 44 may include a plurality of apertures 110 and/or may have a porosity, generally described as openings or ports.
  • These apertures 110 are designed to achieve the desired performance for infusion of therapeutic fluids and evacuation of targeted tissues and fluids and solids of various character, as may occur in relation to treatment of the disease or the delivered therapy.
  • the apertures 110 play a multifaceted role to allow optimal rates of both fluid infusion and fluid aspiration, as well as maintaining free, unhindered flow through the system 2.
  • Specific design elements that affect the performance of the apertures 110 in the distal tip 108 are, for example, the size of the apertures 110, the position of the apertures 110 on the catheter length or tip 108, the position of the apertures 110 relative to the target or surrounding tissue when in use, the position of the apertures 110 relative to the aspiration lumen 106 of the catheter 44, the direction of fluid flow to and from the aspiration lumen 106 relative to the apertures 110, and the cross-sectional flow area of the apertures 110 relative to the flow area of the aspiration lumen 106.
  • the infusion and aspiration function of the catheter 44, tube set 36, and system 2 may also include one or more sensors as part of electronic control systems to achieve the desired function and flow. These may include sensors placed in the catheter tip, on an inner flow surface of the lumina, on the exterior of the lumen (in contact with the body cavity or surrounding tissue), integrated appropriately along the length of the catheter lumen, tubing, cassette, and/or in fluid containers to achieve the desired flow control, bio-physical feedback, and collect bio-chemical information from the patient. These sensors may be arranged to monitor pressure, flow, pump function, pressures within a body cavity, tissue properties, pH- values, among other parameters.
  • pressure sensors can be placed both internally to the catheter 44 and externally on the catheter 44 to measure differential pressure between the body cavity and the infused and/or aspirated fluid.
  • temperature sensors can be placed both internally to the catheter 44 and externally on the catheter 44 to measure differential temperatures between the body cavity and the infused and/or aspirated fluid.
  • one or more MEMS-based sensors may be included to measure fluid velocity within the catheter 44 and determine if higher fluid velocity is needed to break up solids in the aspirated fluid and/or if lower velocities are appropriate for, e.g., aspiration of low viscosity fluids, or the like.
  • the fluid exchange catheter system 2 includes a spinal drainage line 112, such as a drainage catheter, that can be placed in the spinal column of a patient to allow fluid, such as fluid infused into the brain and/or CNS, to drain from the spinal column.
  • the spinal drainage line 112 can be inserted into the spinal column as a “spinal tap.” This spinal drainage line 112 can be in addition to, or in place of, the aspiration function of the catheter 44 described above.
  • the spinal drainage line 112 can be in fluid communication with the drainage receptacle 12 described above such that fluid drained from the spinal column through the spinal drainage line 112 can be collected in the drainage receptacle 12.
  • fluid drained from the spinal drainage line 112 can be collected in a separate drainage location, such as a spinal drainage receptacle 114, that is not attached or connected to the IV pole 6.
  • a spinal drainage receptacle 114 can be in fluid communication, such as through one or more tube sets, with the spinal drainage line 112.
  • the spinal drainage receptacle 114 can be located separate from other aspects of the fluid exchange catheter system 2. Drainage through the spinal drainage line 112 can be aided by a pump that creates negative pressure in the spinal drainage line 112. The pump may be similar to pump 66, and disposed inline with the spinal drainage line 112 or at the drainage receptacle 114. Drainage may also occur through gravity, such as by placing the spinal drainage line 112 at a lower point than the patient’s head, or by other means.
  • the fluid exchange catheter system 2 can be used to manipulate one or more body properties e.g., one or more physiological biomarkers. This manipulation can be achieved through the use of the fluid exchange catheter system 2, and particularly through placement of the catheter 44 into a target area of the body and infusion of fluid to the target area, followed by drainage of fluid from the area either directly through the catheter 44 or instead through a separate drainage mechanism, such as a spinal drainage line 112 placed in the spinal column.
  • the “target area” may be a body cavity or a particular part of a body cavity. In some non-limiting embodiments, the target area is the brain or a particular part of the brain. In other non-limiting embodiments, the target area is the spinal column, abdomen, or lung, or a particular part thereof. The target area can also be a combination of locations and/or body cavities.
  • the present disclosure is directed to a method of facilitating cooling of a target area, such as the brain, using the fluid exchange catheter system 2.
  • the fluid exchange catheter system 2 can deliver a fluid (e.g., a saline or other cooling fluid, including a hypotonic, hypertonic, or isotonic fluid) that facilitates cooling of the target area.
  • a fluid e.g., a saline or other cooling fluid, including a hypotonic, hypertonic, or isotonic fluid
  • one or more sensors e.g., probes
  • ICP ICP
  • temperature e.g., oxygen
  • the fluid exchange catheter system 2 can additionally include a cooling unit 88 that is configured to reduce the temperature of a cooling fluid (e.g., the fluid source 10) to a target value before the fluid reaches the patient.
  • the cooling unit 88 includes one or more ice baths or ice packs.
  • the tube set 36 through which the cooling fluid passes can be immersed in one or more ice baths or surrounded by one or more ice packs along at least a portion of its length, such as at two or three locations along its length. As the cooling fluid passes from the fluid source 10 through the tube set 36, the ice bath/packs cools the fluid contained within tube set 36.
  • the cooling unit 88 includes a heat-exchange device, such as a freezer or refrigerator, within which the fluid source 10 is housed.
  • the heatexchange device can be set to a target temperature, thereby cooling or heating the fluid within fluid source 10 to this target temperature.
  • the tube set 36 may be insulated to limit temperature variation in the cooling fluid as it flows through the tube set 36 after leaving the cooling unit 88.
  • the cooling unit 88 can be at or near the catheter 44.
  • the tube set 36 can enter the heat exchanger where the fluid contained therein can be cooled or heated through heat exchange. The fluid can then exit the heat exchanger and enter the catheter 44 either directly or through another length of the tube set 36.
  • the fluid used for facilitating cooling of a target area can be saline or another cooling fluid.
  • the fluid is a cooling fluid designed to mimic the CSF of a patient.
  • the cooling fluid can include at least 99% water together with various elements such as sodium, potassium, calcium, magnesium, chloride, and glucose at levels that are at or close to typical CSF.
  • the osmolarity and pH can also be adjusted to be at or near the range of CSF, typically an osmolarity of about 300 mOsm/L and a pH in the range of 7.25 to 7.5 (such as 7.33).
  • a sample of CSF of a particular patient can be taken and the cooling fluid contents can be adjusted to more closely align with the CSF of that particular patient.
  • the fluid delivery may additionally provide direct and/or continuous drug delivery of various types and combinations of drugs into the target area.
  • drug delivery can be accomplished by, for example, including the drug with the fluid in the fluid source 10 (e.g., the fluid) that is being delivered in accordance with the methods described herein.
  • the drugs that can be infused are thrombolytic s, antibiotics, other physician prescribed drugs for infusion, and combinations thereof, including drugs and therapeutic agents that can assist with inflammation reduction, such as anti-inflammatory medications (e.g., corticosteroids), or agents that can reduce the metabolism.
  • Other non-limiting examples of drugs can include biological drugs, such as viral or genes.
  • cell metabolism can cause disruption/destruction as a result of injury, and reducing the rate of metabolism within the cell can reduce or limit this disruption/destruction.
  • the target temperature of the fluid at the time of injection into the patient should be below the temperature of the brain and/or CSF of the patient, which is typically around 37°C but may be in the range of 39-40°C if the patient is experiencing a fever or other medical event, such as inflammation.
  • the temperature of the cooling fluid is not necessarily limited to a certain value, the temperature should not be below the crystallization temperature of the fluid itself and/or should not be below a temperature at which the constituents of the fluid begin to phase change or otherwise separate from the fluid.
  • An example temperature target value of the cooling fluid can be between 0°C and 30°C, such as between 10°C and 25°C or between 15°C and 20°C.
  • the temperature target value of the cooling fluid can be around 19°C. However, as mentioned, the target value can be much lower, and can approach 0°C, such as between 0°C than 10°C. As the temperature of the cooling fluid is reduced, the volume of cooling fluid needed to achieve the target cooling level within the body is also reduced since a lower temperature cooling fluid can absorb additional heat per volumetric unit.
  • the target temperature of the body cavity e.g., brain or CNS
  • the target temperature of the body cavity can be achieved more rapidly by utilizing a cooling fluid that is at a low target temperature (e.g., approaching the crystallization temperature) and by controlling the volume of cooling fluid.
  • the body will react by producing a higher volume of CSF that is at an increased temperature (thereby generating additional heat), and the volumetric flow rate of cooling fluid can be selected and/or gradually increased to account for this increase in heat within the brain and CNS.
  • the treatment may begin by preparing the fluid exchange catheter system by installing the tubing system onto a control unit, priming the tubing, calibrating pressure sensors, and entering patient treatment settings.
  • the catheter component can be placed at the correct position in the target area (skull), secured therein with sutures, and tested.
  • Probe(s) can be inserted within the target area near (e.g., next to or integral with) the catheter component to measure temperature and, optionally, oxygen levels, pH, and other biomarkers.
  • the tubing system can then be connected to the catheter component and the height of the control unit can be adjusted to align with the patient’s external auditory meatus (e.g., top of the eyebrow) prior to beginning delivery of the cooling fluid to the brain and/or removal of fluid from the brain.
  • the height of the control unit can be adjusted to align with the patient’s external auditory meatus (e.g., top of the eyebrow) prior to beginning delivery of the cooling fluid to the brain and/or removal of fluid from the brain.
  • excess pressure is an important parameter that requires tight control (e.g. brain)
  • it may be preferred to remove (drain) the fluid before beginning to infuse (irrigate) fluid For other, less sensitive areas, the order of the removal and infusion of fluid may not be as significant.
  • the treatment method can continue until the physiological biomarkers have reached a target value.
  • an example temperature target value of the brain or CNS can be between 25°C and 36°C, such as between 30°C and 35°C or between 32°C and 34°C.
  • the target temperature may also be 2-15°C, such as 3-9°C, 4-8°C, or 4.5-7.5°C, below an initial, or baseline, temperature of the brain.
  • Different sections of the brain may also cool to different levels, which may depend on the location of the injection point. For example, the target temperature in the contralateral brain hemisphere may be higher than the ipsilateral temperature.
  • the target temperature in the contralateral brain hemisphere may be 1.5-4°C, such as 2-3°C, below baseline while the ipsilateral temperature may be 3-9°C, such as 4.5-7.5°C, below baseline.
  • An example pH target value can be between 3.0 and 8.0.
  • the pH of the body cavity can be influenced by the infusion fluid selected.
  • the treatment method can also continue until inflammation is reduced by a clinically valid amount and/or until inflammation reduction is induced.
  • the method can further include control over cytokines and electrolytes which are disrupted when there is a brain injury.
  • the target temperature can be reached in approximately 1 hour, such as 1-2 hours.
  • the treatment method can further include draining spent cooling fluid and/or CSF through the spinal drainage line 112 and into the spinal drainage receptacle 114.
  • This embodiment allows for the cycling of the CSF with cooling fluid through a “volume swap” to thereby rapidly cool the brain and/or CNS of the patient.
  • the total volume of CSF is about 150 mL.
  • the method can involve providing the patient with a near equivalent volume of cooling fluid multiple times over the course of the treatment period.
  • the volumetric flow rate of the cooling fluid is between 100 and 1000 mL/h, such as between 200 and 800 mL/h, during the course of the treatment.
  • the method of treatment may also include returning the temperature of the brain or other body cavity to a temperature at or near the initial/baseline temperature after maintaining the brain or other body cavity at the lower temperature for a period of time, such as a predetermined period of time.
  • the method of treatment can include maintaining the brain or other body cavity at the lower temperature (e.g., 33°C to 34°C) for a set amount of time, such as 24, 48, or 72 hours. This lower temperature can be maintained by continuing to circulate cooling fluid according to the process described above.
  • the temperature can be raised, such as through a steady increase of, for example, 0.05°C to 0.2°C, such as 0.1°C, per hour, until the brain or other body cavity returns to the normal body temperature of 37°C. Raising the temperature can be accomplished by circulating a cooling fluid of an increased temperature.
  • the temperature of the cooling fluid in this step can be at or near (e.g., within 2-3°C) the normal human body temperature.
  • the temperature can be monitored by one or more sensors, including temperature sensors 76, 78, which may be part of the catheter system 2 or may be separate sensors, such as a probe sensor, inserted into the brain or other body area to measure and monitor the temperature and ensure the target temperature is achieved and maintained.
  • the system 2 can also be adapted to automatically provide additional cooling fluid and/or provide the operator with an alarm or other visual or audio indicator, such as audible alarm 62, if the measured temperature exceeds the target temperature by a threshold amount (e.g., by 0.25- 1°C).
  • the objective of an experimental study was to test the hypothesis that by actively exchanging CSF to cooled NaCl and ringer acetate fluid, the brain temperature can be selectively reduced without changes in the core temperature of the porcine body.
  • the method of the study was as follows. A double lumen external ventricular drainage (“EVD”) catheter was inserted into the lateral ventricle of four porcines. A spinal drainage line was added to accelerate CSF exchange to cooled NaCl (one porcine) or ringer acetate (three porcine) fluids. Brain parenchymal temperature was measured from the contralateral brain hemisphere and the ipsilateral brain hemisphere. CSF was exchanged to cooled fluid in four porcine with rates of 180ml-720ml/h. In two porcine, a global stroke was induced globally via endovascular method by closing the main arteries of the brain for 20 minutes.
  • ESD external ventricular drainage

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Abstract

La divulgation concerne un procédé de changement sélectif d'une température d'une cavité corporelle d'une température de base à une température cible qui est différente de la température de base. Le procédé comprend l'activation d'un mécanisme de perfusion pour perfuser un fluide à travers un premier trajet de fluide et une lumière de perfusion dans un composant de cathéter vers la cavité corporelle pendant une période de temps de perfusion. Le fluide est amené à une température de fluide cible avant d'atteindre la cavité corporelle. Le procédé comprend également l'élimination périodique ou continue d'au moins une partie du fluide à travers un second trajet de fluide, la surveillance d'une température de la cavité corporelle, et le maintien de la température cible pendant une période de temps prédéterminée.
PCT/US2023/078617 2022-11-04 2023-11-03 Systèmes et procédés de manipulation de propriétés corporelles à l'aide d'un cathéter d'échange de fluide WO2024097946A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7156867B2 (en) * 2001-12-31 2007-01-02 Medcool, Inc. Uniform selective cerebral hypothermia
US7318834B2 (en) * 2004-02-09 2008-01-15 Philip Chidi Njemanze Apparatus and method for hypothermia and rewarming by altering the temperature of the cerebrospinal fluid in the brain
US8043247B1 (en) * 2005-04-05 2011-10-25 Glenn Bradley J Subarachnoid epidural shunt
US20120095537A1 (en) * 2010-02-08 2012-04-19 Hall Gregory W Method and Apparatus for Inducing Therapeutic Hypothermia
US20160375221A1 (en) * 2012-08-10 2016-12-29 Irras Ab Fluid exchange catheter and process for unblocking a fluid exchange catheter
US20200237977A1 (en) * 2017-03-17 2020-07-30 Irras Ab Fluid Exchange System and Related Methods

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7156867B2 (en) * 2001-12-31 2007-01-02 Medcool, Inc. Uniform selective cerebral hypothermia
US7318834B2 (en) * 2004-02-09 2008-01-15 Philip Chidi Njemanze Apparatus and method for hypothermia and rewarming by altering the temperature of the cerebrospinal fluid in the brain
US8043247B1 (en) * 2005-04-05 2011-10-25 Glenn Bradley J Subarachnoid epidural shunt
US20120095537A1 (en) * 2010-02-08 2012-04-19 Hall Gregory W Method and Apparatus for Inducing Therapeutic Hypothermia
US20160375221A1 (en) * 2012-08-10 2016-12-29 Irras Ab Fluid exchange catheter and process for unblocking a fluid exchange catheter
US20200237977A1 (en) * 2017-03-17 2020-07-30 Irras Ab Fluid Exchange System and Related Methods

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