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WO2025230817A1 - Systèmes pour procédures minimalement invasives dans des espaces extravasculaires - Google Patents

Systèmes pour procédures minimalement invasives dans des espaces extravasculaires

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Publication number
WO2025230817A1
WO2025230817A1 PCT/US2025/026277 US2025026277W WO2025230817A1 WO 2025230817 A1 WO2025230817 A1 WO 2025230817A1 US 2025026277 W US2025026277 W US 2025026277W WO 2025230817 A1 WO2025230817 A1 WO 2025230817A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
endovascular
delivery catheter
shunt device
catheter
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2025/026277
Other languages
English (en)
Inventor
Adel M. Malek
Carl Heilman
Travis CARBONNEAU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cerevasc Inc
Original Assignee
Cerevasc 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 Cerevasc Inc filed Critical Cerevasc Inc
Publication of WO2025230817A1 publication Critical patent/WO2025230817A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3401—Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00876—Material properties magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00982—General structural features
    • A61B2017/00986—Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1139—Side-to-side connections, e.g. shunt or X-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • 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

Definitions

  • the inventions disclosed herein relate to systems and methods for endovascularly accessing extravascular spaces, such as the subarachnoid or subdural spaces, and performing additional therapeutic procedures in the extravascular spaces, such as draining cerebrospinal fluid (CSF) to treat hydrocephalus, pseudotumor cerebri, or intracranial hypertension.
  • CSF cerebrospinal fluid
  • minimally invasive refers to the use of surgical devices and implants that access the vasculature of the body via arterial or venous access in the groin, arm or neck area, as opposed to more invasive traditional procedures that access the body more directly through percutaneous/solid tissue incisions and cutting and/or boring through bones, as needed to access the internal area of the body on which the procedure is performed.
  • minimally invasive can also refer to the to the use of surgical devices and implants that access the body via other natural body orifices, cavities and tubular structures, such as the esophagus, intestines, bronchial passageways, etc.
  • Percutaneous access through the skin into solid tissue, e.g., for accessing the liver, prostate or lungs, e.g., using a trocar and stylet, can also be considered minimally invasive.
  • One minimally invasive surgical technique involves treating hydrocephalus, pseudotumor cerebri, and/or intracranial hypertension by endovascularly creating an anastomosis between the lumen of the inferior petrosal sinus (IPS) and the subarachnoid space (SAS) of the patient, implanting an endovascular shunt device within the anastomosis, and draining excess cerebral spinal fluid (CSF) from the CSF-filled SAS into the venous system of the patient via the implanted shunt device, where the excess CSF is reabsorbed into the body of the patient.
  • endovascular devices and procedures to drain CSF from the CSF-filled SAS into the venous system of a patient are described in U.S. Patent Nos.
  • an anastomosis between the CSF-filled SAS and the IPS is created by piercing the wall of the IPS with a penetrating element (e.g., a needle, surgical tool, radio frequency (RF) stylet, or the like) associated with an endovascular catheter to access the CSF-filled SAS, and then installing a endovascular shunt device through the wall of the IPS between the CSF-filled SAS and the lumen of the IPS.
  • a penetrating element e.g., a needle, surgical tool, radio frequency (RF) stylet, or the like
  • these critical anatomical structures provide unobstructed access to the CSF-filled SAS to accommodate the penetrating element and the endovascular shunt device.
  • one or more of the critical anatomical structures are close enough to the IPS to obstruct safe access to the CSF- filled SAS.
  • these adjacent critical anatomical structures can complicate or increase the time surgical time of the endovascular procedure, and at worst, can exclude such patients from being endovascularly treated, thereby requiring them to undergo more invasive procedures to treat the hydrocephalus, pseudotumor cerebri, intracranial hypertension, and/or chronic subdural hematoma.
  • a shunting system comprises an endovascular shunt device, a shunt delivery catheter comprising a lumen configured for housing the endovascular shunt device, a penetrating element configured for piercing or penetrating through a wall of a vessel into an extravascular space (e.g., a subarachnoid space (SAS)) to create an anastomosis with the blood vessel wall, and an atraumatic distal protective element configured for deflecting a critical anatomical structure (CAS) residing within the extravascular space away from the penetrating element.
  • the shunting system can optionally comprise a delivery wire to which the endovascular shunt device is releasably secured.
  • the penetrating element is disposed on a distal tip of the shunt delivery catheter.
  • the atraumatic distal protective element can be affixed to a distal end of the endovascular shunt device or a distal end of the shunt delivery catheter.
  • the shunting system further comprises a stylet having a distal tip on which the penetrating element is disposed, and the shunt delivery catheter is configured for interchangeably housing the stylet and the endovascular shunt device.
  • the atraumatic distal protective element can be affixed to a distal end of the stylet.
  • the atraumatic distal protective element is configured for physically deflecting the CAS residing within the extravascular space away from the penetrating element.
  • the atraumatic distal protective element can have elastic and/or compressible properties and be configured for transitioning from a compressed configuration when advanced through the wall of the vessel to an expanded configuration when disposed in the extravascular space.
  • the atraumatic distal protective element can be composed of an elastomeric polymer or one of a spring or coil, solid elastic material, flexible hypotube, and compressed foam.
  • the atraumatic distal protective element can optionally comprise a radiopaque material.
  • the atraumatic distal protective element can be configured for magnetically deflecting the CAS residing within the extravascular space away from the penetrating element.
  • the atraumatic distal protective element can comprise one or more magnetic elements
  • the shunting system can further comprise a magnetized insert comprising an elongate shaft and a magnetic element affixed to a distal end of the elongate shaft, and another delivery catheter comprising a lumen configured for housing the magnetized insert.
  • the magnetic element(s) of the atraumatic distal protective element and the magnetic element of the magnetized insert can be configured for repelling each other when the magnetic element of the magnetized insert is disposed in the CAS, thereby deflecting the CAS residing within the extravascular space away from the penetrating element.
  • the endovascular shunt device comprises a proximal portion having one or more proximal openings configured for residing in the lumen of the vessel, a distal portion having one or more distal openings configured for residing in the extravascular space, a shunt lumen in fluid communication with the proximal opening(s) and the distal opening(s), and a distal anchoring mechanism affixed to the distal portion and configured for anchoring the distal portion of the endovascular shunt device within the extravascular space.
  • the protective element can extend distally relative to the distal anchoring mechanism and can be affixed to the distal anchoring mechanism.
  • the atraumatic distal protective element can optionally be configured for maintaining the distal opening(s) unobstructed from the extravascular space.
  • the distal anchoring mechanism can be configured for residing within the extravascular space.
  • a method for endovascularly accessing an extravascular space e.g., a subarachnoid space (SAS) of a patient.
  • the method comprises advancing an endovascular delivery catheter within a vessel (e.g., a dural venous sinus, such as an inferior petrosal sinus (IPS)) to a target penetration site, penetrating a wall of the vessel with a penetrating element at the target penetration site, such that the penetrating element, at least partially, resides within the extravascular space, and deflecting a critical anatomical structure (CAS) (e.g., a basilar artery, an anterior inferior cerebellar artery, or a brainstem) residing within the extravascular space away from the penetrating element.
  • the CAS can be, e.g., physically deflected or magnetically deflected away from the penetrating element.
  • the penetrating element is disposed on a distal tip of the delivery catheter, in which case, the wall can be penetrated by the penetrating element at the target penetration site by advancing the distal tip of the delivery catheter through the wall of the vessel.
  • penetrating the wall of the vessel creates an anastomosis, in which case, the method can further comprise advancing a distal end of an endovascular shunt device from a lumen of the delivery catheter, through the anastomosis, and into the extravascular space.
  • the penetrating element can be disposed on the distal tip of the delivery catheter or a distal tip of a stylet disposed within a lumen of the delivery catheter, in which case, the wall can be penetrated by the penetrating element at the target penetration site by advancing the distal tip of the delivery catheter through the wall of the vessel, such that the CAS is deflected away from the penetrating element by a distal protective element affixed to one of the distal end of the endovascular shunt device, a distal end of the delivery catheter, and a distal end of the stylet.
  • the distal protective element can be affixed to the distal end of the endovascular shunt device, in which case, the CAS can be deflected away from the penetrating element by the distal protective element as the distal end of the endovascular shunt device is distally advanced into the extravascular space.
  • the distal protective element can be affixed to the distal end of the delivery catheter or the distal end of the stylet, in which case, the CAS can be deflected away from the penetrating element by the distal protective element as the distal tip of the delivery catheter is advanced through the wall of the vessel into the extravascular space.
  • the distal protective element can transition from a compressed configuration when advanced through the wall of the vessel to an expanded configuration in the extravascular space as the distal end of the endovascular shunt device is advanced through the wall of the vessel into the extravascular space.
  • the distal protective element can maintain an opening in the distal end of the endovascular shunt device unobstructed by the CAS.
  • an endovascular shunt device is configured for being disposed in an anastomosis between an subarachnoid space (SAS) and a lumen of the vessel.
  • the endovascular shunt device comprises a proximal portion having one or more proximal openings configured for residing in the lumen of the vessel, a distal portion having one or more distal openings configured for residing in the SAS, a shunt lumen in fluid communication with the one or more proximal openings and the one or more distal openings, a distal anchoring mechanism affixed to the distal portion, the distal anchoring mechanism configured for anchoring the distal portion of the endovascular shunt device within the SAS, and an atraumatic distal protective element extending distally relative to the distal anchoring mechanism, the distal protective element configured for deflecting a CAS when the endovascular shunt device is disposed in the anastomosis.
  • the distal anchoring mechanism is configured for residing within the SAS.
  • the atraumatic distal protective element is affixed to the distal anchoring mechanism.
  • the atraumatic distal protective element can have compressible properties and be configured for transitioning from a compressed configuration when advanced through a wall of the vessel to an expanded configuration when disposed in the SAS.
  • the atraumatic distal protective element can be composed of an elastomeric polymer, or one of a spring or coil, solid elastic material, flexible hypotube, and compressed foam.
  • the atraumatic distal protective element can optionally comprise a radiopaque material
  • the atraumatic distal protective element comprises one or more magnetic elements.
  • a medical system comprises a medical tool configured for accessing an internal region of a patient, the medical tool comprising an elongate member, a first magnetic element physically associated with a distal end of the elongate member (e.g., affixed to the distal tip of the elongate member), and a magnetized insert comprising an elongate shaft and a second magnetic element affixed to a distal end of the elongate shaft, the magnetized insert configured for intraluminally accessing an anatomical structure of the patient.
  • the medical system can optionally comprise a delivery catheter having a lumen configured for housing the magnetized insert.
  • the medical tool further comprises a penetrating element disposed on a distal tip of the elongate member.
  • the medical tool can, e.g., comprise a percutaneous needle or an intravascular catheter. In the latter case, the medical tool can further comprise a stylet configured for being housed within the intravascular catheter.
  • the intravascular catheter can be, e.g., a delivery catheter having a lumen, in which case, the medical system can further comprise an endovascular shunt device configured for being housed within the lumen.
  • the first magnetic element can be affixed to a distal end of the endovascular shunt device.
  • the anatomical structure can be a blood vessel, in which case, the magnetized insert can be configured for intraluminally accessing the blood vessel via a vasculature of the patient.
  • the anatomical structure is a gastrointestinal anatomical structure, in which case, the magnetized insert can be configured for intraluminally accessing the gastrointestinal anatomical structure via the gastrointestinal tract of the patient.
  • the first magnetic element and the second magnetic element are configured for magnetically interacting with each other, such that the anatomical structure is deflected relative to a distal tip of the medical tool.
  • the same poles of the first magnetic element and the second magnetic element can be configured for magnetically repelling each other, such that the anatomical structure is deflected away from the distal tip of the medical tool.
  • different poles of the first magnetic element and the second magnetic element can be configured for magnetically attracting each other, such that the anatomical structure is deflected toward the distal tip of the medical tool.
  • a method of performing a medical procedure comprises accessing an internal region of a patient with a medical tool, and disposing a first magnetic element (which can be affixed to a distal tip of the medical tool) within the internal region.
  • the internal region of the patient can, be intraluminally or endoluminally accessed by the medical tool.
  • the internal region of the patient can be an extravascular space, in which case, accessing the extravascular space can comprise endovascularly accessing the extravascular space.
  • the medical procedure can comprises implanting an endovascular shunt device into the extravascular space.
  • the internal region of the patient can be percutaneously accessed by the medical tool.
  • the method further comprises intraluminally accessing an anatomical structure, and disposing a second magnetic element within the anatomical structure.
  • the anatomical structure is a blood vessel, in which case, the blood vessel can be intravascularly accessed.
  • the anatomical structure can be a gastrointestinal anatomical structure that is intraluminally accessed via the gastrointestinal tract.
  • the method further comprises magnetically deflecting the anatomical structure relative to a distal tip of the medical tool while accessing the internal region of the patient via interaction between the first magnetic element and the second magnetic element.
  • the anatomical structure is magnetically deflected away from the distal tip of the medical tool via a magnetic repelling force between the first magnetic element and the second magnetic element.
  • the anatomical structure is magnetically deflected toward the distal tip of the medical tool via a magnetic attraction force between the first magnetic element and the second magnetic element.
  • the method comprises operating the medical tool to perform the medical procedure.
  • the medical tool is operated to perform the medical procedure on the patient while the anatomical structure continues to be magnetically deflected relative to the distal tip of the medical tool.
  • a method for endovascular treatment of a chronic subdural hematoma (CSH) in a patient comprises advancing an access catheter to a target penetration site in a wall of a dural venous sinus.
  • the access catheter comprises a penetrating element on a distal end portion of the catheter, and the target penetration site is adjacent or proximate to the CSH.
  • the method further comprises penetrating the wall at the target penetration site with the delivery catheter so that the penetrating element is disposed within the CSH, and aspirating the CSH through a lumen in the access catheter.
  • One method further comprises occluding the CSH, e.g., by delivering a vasoocclusive device through the catheter lumen to the CSH, or delivering a liquid embolic agent through the catheter lumen to the CSH.
  • another method for endovascular treatment of CSH) in a patient comprises advancing an access catheter to a target penetration site in a wall of a dural venous sinus.
  • the access catheter comprises a penetrating element on a distal end portion of the catheter and wherein the target penetration site is adjacent or proximate to the CSH, penetrating the wall at the target penetration site with the delivery catheter so that the penetrating element is disposed within the CSH, and advancing a second catheter through a lumen in the access catheter until a distal end portion of the second catheter is disposed with the CSH.
  • the second catheter has a lumen extending from the distal end portion to a proximal end portion.
  • the method further comprises aspirating the CSH through the second catheter lumen.
  • One method further comprises occluding the CSH, e.g, by delivering a vaso-occlusive device through the second catheter lumen to the CSH, or delivering a liquid embolic agent through the second catheter lumen to the CSH.
  • FIG. 1 is an anterior view of a head of a human patient, particularly showing relevant vascular structures of the head;
  • FIG. 2 is a median sagittal view of a head of the human patient, particularly showing relevant vascular structures of the head;
  • FIG. 3 is a plan view of one embodiment of an endovascular delivery assembly constructed in accordance with the present inventions
  • FIGS. 4A-4C are plan views of one embodiment of an endovascular cerebrospinal fluid (CSF) shunt device constructed in accordance with the present inventions;
  • CSF cerebrospinal fluid
  • FIGS. 5A-5C are plan views of variations of the endovascular CSF shunt device of FIGS. 4A-4B constructed in accordance with the present inventions;
  • FIG. 5D is a plan view of an alternative embodiment a shunt delivery catheter for use with the endovascular delivery system of FIG. 3 constructed in accordance with present inventions;
  • FIG. 6 is a flowchart of one method of implanting the endovascular CSF shunt device of FIGS. 4A-4B within a cerebellopointine (CP) angle cistern of the human patient using the endovascular delivery system of FIG. 3 in accordance with the present inventions;
  • CP cerebellopointine
  • FIGS. 7A-7F are median sagittal views of the head of the human patient, particularly showing the arrangement of the endovascular CSF shunt device of FIGS. 4A-4B and the endovascular delivery system of FIG. 3 during the method performed in FIG. 6;
  • FIG. 8 is a flowchart of one method of implanting an endovascular CSF shunt device within a CP angle cistern of the human patient using the endovascular delivery system of FIG. 3 with the alternative embodiment of the shunt delivery catheter of FIG. 5D in accordance with the present inventions;
  • FIGS. 9A-9G are median sagittal views of the head of the human patient, particularly showing the arrangement of an endovascular CSF shunt device and the delivery catheter FIG. 3 with the alternative embodiment of the shunt delivery catheter of FIG. 5D in accordance with the present inventions;
  • FIG. 10 is a plan view of another embodiment of an endovascular delivery assembly constructed in accordance with the present inventions.
  • FIGS. 11A-11B are plan views of another embodiment of an endovascular CSF shunt device constructed in accordance with the present inventions.
  • FIG. 12 is a flowchart of one method of implanting an endovascular CSF shunt device (or alternatively, the endovascular CSF shunt device of FIGS. 11A-11 B) within the CP angle cistern of the human patient using the endovascular delivery system of FIG. 10 in accordance with the present inventions;
  • FIGS. 13A-13G are median sagittal views of the head of the human patient, particularly showing the arrangement of an endovascular CSF shunt device (or alternatively, the endovascular CSF shunt device of FIGS. 11A-11 B) and the endovascular delivery system of FIG. 10 during the method performed in FIG. 12;
  • FIG. 14 is a plan view of an embodiment of a medical system constructed in accordance with the present inventions.
  • FIG. 15 is a flowchart of one method of performing a medical procedure on a patient using the medical system of FIG. 14;
  • FIGS. 16A-16B are schematic diagrams of one method of treating an internal region of a patient using the medical system of FIG. 14 without damaging an anatomical structure of the patient;
  • FIG. 17A-17C are schematic diagrams of one method of treating an anatomical structure of a patient using the medical system of FIG. 14;
  • FIGS. 18A-18B are schematic diagrams of methods of treating a subdural hematoma in accordance with the present inventions.
  • FIGS. 19A-19D are perspective views of fasten members of an alternative embodiment of a delivery catheter in accordance with the present inventions.
  • Disclosed and depicted herein are systems, devices and methods for use in performing minimally invasive surgical procedures in extravascular spaces, including the subarachnoid space (SAS) and subdural space (SDS).
  • the disclosed devices can be used in the venous or arterial vasculature to pass through a vessel wall and/or other tissue to access a location outside the vasculature.
  • Non-limiting examples include transvenous or transarterial neurosurgery.
  • the disclosed systems and devices advantageously avoid the need for drilling a hole in the patient’s skull in order to access areas surrounding the brain, as well as brain tissue during a surgical procedure.
  • an inferior petrosal sinus (IPS) 102 connects a cavernous sinus (CS) 104 to a jugular vein 106 and/or a jugular bulb 108.
  • IPS cavernous sinus
  • CS cavernous sinus
  • IPS is used herein to refer generally to the inferior petrosal sinus and more particularly to the interior space (or lumen) of the inferior petrosal sinus.
  • the IPS 102 is a relatively small diameter intracranial venous sinus that facilitates drainage of cerebral venous blood into the jugular veins 106. In some patients, the junction of the IPS 102 and the jugular vein 106 occurs within the jugular bulb 108.
  • this junction can occur at other locations in the jugular vein 106.
  • the IPS 102 is illustrated in FIGS. 1 and 2 as a single sinus passageway, in some patients, the IPS can be a plexus of separate channels that connect the CS 104 to the jugular vein 106 (not shown) and/or the jugular bulb 108.
  • a superior petrosal sinus (SPS) 122 also connects the CS 104 to a sigmoid sinus (distally located to jugular bulb 108).
  • the IPS 102 is formed by a cylindrical layer of dura mater 114, which creates a hollow lumen through which blood flows.
  • a cross-section of the IPS 102 orthogonal to the plane depicted in FIG. 2 would show that the cylindrical layer of dura mater 114 forming the IPS 102 is surrounded by bone for about 270° of its circumference with the remaining portion of the circumference of the IPS 102 (i.e., the IPS wall 114) covered by a delicate and avascular layer of arachnoid matter 115 (also referred to herein as the arachnoid layer).
  • the IPS wall 114 can be topological divided between an upper IPS wall 114a outside of which a portion of the intracranial subarachnoid space (SAS) 116, and in particular, the cerebellopointine (CP) angle cistern 138, resides, and an lower IPS wall 114b that sits in a channel in the clivus bone (not shown).
  • SAS intracranial subarachnoid space
  • CP cerebellopointine
  • a suprasellar cistern 148 exists above the upper portion or roof of the CS 104.
  • the CP angle cistern 138 and suprasellar cistern 148 are both filled with cerebrospinal fluid (CSF).
  • CSF cerebrospinal fluid
  • Critical anatomical structures CASs including, but not limited to, arterial structures 110 (e.g., a basilar artery or anterior inferior cerebellar artery), brain stem 112, and cranial nerves (not shown) reside within the CP angle cistern 138 and/or suprasellar cistern 148.
  • Embodiments of the disclosed inventions are described with respect to an exemplary target penetration site in the IPS 102 to access the CSF-filled CP angle cistern 138 for delivering an implant at a target implantation site within an anastomosis between the IPS 102 and the CP angle cistern 138, while avoiding contact or injury to an arterial structure 110 within the CP angle cistern 138.
  • embodiments of the delivery assemblies, catheters and other endovascular components disclosed herein can penetrate, for example, the IPS wall 114 and the arachnoid layer 115 to access the CP angle cistern 138 from within the IPS 102 for delivery of an endovascular CSF shunt device 250 (illustrated in FIGS.
  • the CSF-filled CP angle cistern 138 can be accessed from a target penetration site in the SPS 122 for implantation of the endovascular CSF shunt device 250 at the target implantation site within an anastomosis between the SPS 122 and the CP angle cistern 138, or the CSF-filled suprasellar cistern 148 can be accessed from a target penetration site in the upper portion or roof of the CS 104 (via the IPS 102) for implantation of the endovascular CSF shunt device 250 at a target implantation site within an anastomosis between the CS 104 and the suprasellar cistern 148.
  • a shunt delivery assembly 200 for creating an anastomosis via an endovascular approach between a venous sinus (such as the IPS 102) and the SAS 116 (such as the CP angle cistern 138), and implanting an endovascular CSF shunt device 250 at a target implantation site within the anastomosis will now be described.
  • the combination of the shunt delivery assembly 200 and the endovascular CSF shunt device 250 constitutes a CSF shunting system.
  • the shunt delivery assembly 200 comprises an assembly having an guide catheter 202 and a shunt delivery catheter 204 coaxially disposed within and movable relative to a lumen (not shown) of the guide catheter 202.
  • the shunt delivery catheter 204 facilitates navigation and delivery of the endovascular CSF shunt device 250 through the patient’s vasculature to the target implantation site.
  • the shunt delivery catheter 204 comprises a lumen (not shown) for housing the endovascular CSF shunt device 250.
  • the shunt delivery catheter 204 is dimensioned to percutaneously reach the CP angle cistern 138 from a venous access location in the patient (e.g., femoral vein, cephalic vein, brachial vein, subclavian vein, internal jugular vein).
  • a venous access location in the patient e.g., femoral vein, cephalic vein, brachial vein, subclavian vein, internal jugular vein.
  • the shunt delivery assembly 200 can include a guidewire 206 coaxially disposed within the lumens of the guide catheter 202 and/or the shunt delivery catheter 204.
  • the guidewire 206 can be, for example, 0.035" (0.889 mm) in diameter.
  • the shunt delivery assembly 200 can include a delivery wire 208 disposed within the shunt delivery catheter 204 for delivery of the endovascular CSF shunt device 250.
  • the delivery wire 208 has a smaller diameter (e.g., approximately 0.010” (0.254 mm) to 0.018” (0.4572 mm) or other suitable dimension to facilitate accessing intracranial venous vasculature with other components of shunt delivery assembly 200) compared to guidewire 206.
  • the guide catheter 202, shunt delivery catheter 204, and wires 206/208 can be formed of suitable biocompatible materials.
  • the shunt delivery assembly 200 further comprises a penetrating element 210 configured for piercing and/or penetrating a venous sinus wall (e.g., IPS wall 114 and arachnoid layer 115 to access the CP angle cistern 138).
  • a venous sinus wall e.g., IPS wall 114 and arachnoid layer 115 to access the CP angle cistern 138.
  • the penetrating element 210 is affixed to the distal tip of the shunt delivery catheter 204.
  • the penetrating element 210 can be affixed to the distal tip of a stylet that is slidably disposed in the lumen of the shunt delivery catheter 204, as described in PCT Publication WO 2016/070147, which is expressly incorporated herein by reference.
  • the shunt delivery assembly 200 can further comprise one or more radiopaque marker bands 212 at a distal portion 214 of the guide catheter 202 to allow viewing of distal portion 214 under fluoroscopy and a Luer assembly 216 for providing access to the wires 206/208 and/or fluids.
  • the endovascular CSF shunt device 250 comprises a cylindrical shunt body 252 having a proximal body portion 254 and a distal body portion 256.
  • the endovascular CSF shunt device 250 further comprises a shunt lumen 258 extending through the shunt body 252.
  • the shunt body 252 can be composed of elastomeric polymer(s) suitable for implant applications including, but not limited to, silicone, polyurethane, polycarbonate urethane, thermoplastic polyurethane, aromatic or aliphatic polycarbonate thermoplastic polyurethane, silicone/polyurethane blends (e.g., thermoplastic silicone polycarbonate polyurethane comprising 20% silicone copolymer), or polyurethane silicone blends (e.g., polyurethane silicone copolymer).
  • the materials from which the shunt body 252 is composed can be selected to advantageously resist thrombus formation, particularly on the proximal body portion 254 of the endovascular CSF shunt device 250.
  • the endovascular CSF shunt device 250 includes an anti-thrombotic coating disposed on the shunt body 252 to prevent thrombus formation including, but not limited to, heparin-based or phosphorylcholine-based anti-thrombotic coatings.
  • the endovascular CSF shunt device 250 further comprises a valve 260 affixed to the proximal body portion 254 in fluid communication with the shunt lumen 258.
  • the valve 260 is configured for being in fluid communication with the shunt lumen 258.
  • the valve 260 is a one-way valve comprising one or more slits 262.
  • the endovascular CSF shunt device 250 further comprises a radiopaque marker 264, which in the illustrated embodiment, takes the form of a cylindrical band embedded in the distal body portion 256 of the endovascular CSF shunt device 250.
  • the marker 264 can be swaged over the distal body portion 256 of the endovascular CSF shunt device 250.
  • the marker 264 is composed of any suitable radiopaque material and comprises a suitable surface area to assist visualization of the endovascular CSF shunt device 250 under fluoroscopy, avoiding or minimizing risks to patient when accessing the CP angle cistern 138.
  • the CSF shunt device 250 further comprises a distal anchoring mechanism 266 (e.g., a malecot) affixed to the distal body portion 256.
  • the distal anchoring mechanism 266 has a compressed configuration (FIG. 4A) for advancement within the lumen of the shunt delivery catheter 204 and an expanded configuration (FIGS. 4B- 4C) for anchoring the endovascular CSF shunt device 250 at the target implantation site in the anastomosis created between a venous sinus and the SAS 116 of the patient, and in this case, between the IPS 102 and the CP angle cistern 138.
  • the distal anchoring mechanism 266 is composed of titanium, stainless steel, Nitinol, or other super-elastic alloys.
  • the distal anchoring mechanism 266 comprises a proximal retainer element or collar 268, a distal radiopaque marker 270, and a plurality of elongated deformable elements 272 (e.g., arms) disposed therebetween.
  • the collar 268 and the distal marker 270 are composed of suitable radiopaque materials and can comprise an annular configuration.
  • the deformable elements 272 are disposed radially outward in the expanded configuration of the distal anchoring mechanism 266.
  • the distal anchoring mechanism 266 transitions (e.g., self-expands) from the compressed configuration (FIG. 4A) within the shunt delivery catheter 204 to its expanded or deployed configuration (FIGS. 4B-4C).
  • the clinician can observe the collar 268 and the distal marker 270 move closer together, confirming that the distal anchoring mechanism 266 has properly transitioned to its the expanded or deployed configuration.
  • the retainer element or collar 268 defines one or more distal end openings 274 at the distal body portion 256 of the endovascular CSF shunt device 250.
  • the distal end openings 274 are in fluid communication with the shunt lumen 258 and the valve 260 at the proximal body portion 254 of the endovascular CSF shunt device 250 (e.g., drain CSF).
  • a target deployment site e.g., anastomosis between a venous sinus and an intracranial SAS 116, shown in FIG. 6C
  • CSF within the SAS 116 drains through the endovascular CSF shunt device 250 into the venous system, via the distal end openings 274, shunt lumen 258 and valve 260 of the endovascular CSF shunt device 250.
  • the endovascular CSF shunt device 250 further comprises a distal protective element 276 designed to deflect one or more CASs, e.g., an arterial structure 110, away from the penetrating element 210 of the shunt delivery catheter 204 after piercing through the I PS wall 114 and arachnoid layer 115 into the CP angle cistern 138.
  • the distal protective element 276 is disposed distally from the distal marker 270 of the distal anchoring mechanism 266, such that the distal protective element 276 is the only portion of the endovascular CSF shunt device 250 that contacts the arterial structure 110, as will be described in further detail below.
  • the distal protective element 276 comprises an atraumatic configuration with elastic and/or compressible properties.
  • the distal protective element 276 is composed of suitable biocompatible materials having elastic properties, for example Nitinol or any of the elastomeric polymers disclosed herein with respect to shunt body 202.
  • the distal protective element 276 can comprise radiopaque material, so that a separate distal marker 270 is optional.
  • the distal protective element 276 takes the form of a spring or coil.
  • the distal protective element 276 can, e.g., take the form of a solid elastic material (FIG. 5A), such as a polymeric elongated portion 278 with an atraumatic end tip 280 (e.g., rounded, semi-spherical), flexible hypotube 282 having a plurality of cuts or slots 284 to increase flexibility and an atraumatic end tip 280 (FIG.
  • hypotube 286 comprising compressed foam having an atraumatic end tip 280 (FIG. 5C), or their like.
  • the distal protective element 276 can take the form of a spring or coil, the inner diameter of which accommodates the penetrating element 210 of the shunt delivery catheter 204’, as shown in FIG. 5D, or the distal protective element 276 can be received within the inner diameter of penetrating element 210.
  • a spring or coil as a distal protective element, instead of being affixed directly to the distal of the shunt delivery catheter 204’, can be affixed to the distal tip of the stylet.
  • an inner diameter of the spring or coil can accommodate the penetrating element of the stylet.
  • the distal protective element 276 is designed to deflect one or more CASs, e.g., an arterial structure 110, away from the penetrating element 210 as it pierces through the IPS wall 114 and arachnoid layer 115 into the CP angle cistern 138.
  • the endovascular CSF shunt device 250 can be advanced within and out of the shunt delivery catheter 204 via the delivery wire 208 and optional shuttle or shroud (not shown), such as those described in U.S. Patent Nos. 10,272,230 and 10,765,846, U.S. Patent Publication No. 2020/0030588, and PCT Publication WO 2023/178077, the entire disclosures of which have been expressly incorporated herein by reference as though set forth in full.
  • the distal protective element 276 can, instead of being affixed directly to the distal anchoring mechanism 266, be affixed to the distal end of the shuttle, shroud or delivery wire 208 configured for delivering the endovascular CSF shunt device 250 from the shunt delivery catheter 204.
  • the endovascular CSF shunt device 250 can include any additional features of the endovascular CSF shunt embodiments disclosed in U.S. Patent Publication Nos. US 2020/0376239, and US 2020/0030588, U.S. Patent No. 1 1 ,951 ,270 and PCT Publication No. WO 2023/178077.
  • the disclosure of each of the foregoing applications is expressly incorporated by reference herein in its entirety.
  • FIGS. 6 and 7A-7F an exemplary method 300 of endovascularly creating an anastomosis between the IPS 102 and the CP angle cistern 138 and implanting an endovascular CSF shunt device within the anastomosis, while avoiding contact or injury to an arterial structure 110 within the CP angle cistern 138 will now be described.
  • the method 300 first comprises evaluating the target implantation site 140 in the IPS 102 using one or more imaging systems (e.g., MRI, CT, cone-beam CT) (step 302), and confirming whether there are any CAS’s 160 (e.g., an arterial structure) proximate to the target implantation site in the IPS wall 114 (step 304).
  • imaging systems e.g., MRI, CT, cone-beam CT
  • CAS’s 160 e.g., an arterial structure
  • suitable imaging methods include biplane fluoroscopy, digital subtraction angiography with road mapping technology, venous angiography with road mapping technology, 3D-rotational angiography or venography (3DRA or 3DRV), and cone-beam computed tomographic angiography or venography (CBCTA or CBCTV).
  • Both 3DRA/V and CBCTAA/ enable volumetric reconstruction showing the relationship between the bony anatomy, the vascular anatomy and the endovascular componentry used in minimally invasive procedures to cross a blood vessel wall (e.g., by penetrating through the vessel wall) to access the subarachnoid space.
  • a 3DRA/V and CBCTA/V volumetric reconstruction can be overlaid, registered, combined and/or matched to real-time fluoroscopy imaging using a 3D roadmap technique (e.g., using Siemens syngo 3D Roadmap and syngo Toolbor, or Phillips Dynamic 3D Roadmap) that facilitates an overlay, registration, combination, and/or matching of a point(s) of interest (e.g., the target penetration site 140, arterial structure 110, etc.) from the 3D or volumetric reconstruction (e.g., DynaCT from Siemens Healthcare, XperCT from Phillips) with real-time 2D fluoroscopy images.
  • Magnetic resonance imaging MRI provides additional valuable information about the anatomy surrounding intended or target access locations to the subarachnoid space, which MRI can also be overlaid, registered, combined and/or matched with real-time fluoroscopy and a 3D reconstruction.
  • the method 300 further comprises selecting an endovascular CSF shunt device having a distal protective element (e.g., any one of the endovascular CSF shunt devices 250 illustrated in FIGS. 4A-4B and 5A-5C), or alternatively, a shunt delivery wire or shroud having a distal protective element) (step 306a).
  • an endovascular CSF shunt device having a distal protective element e.g., any one of the endovascular CSF shunt devices 250 illustrated in FIGS. 4A-4B and 5A-5C
  • a shunt delivery wire or shroud having a distal protective element
  • An anastomosis is then created between the IPS 102 and the CP angle cistern 138 and the selected endovascular CSF shunt device is implanted within the anastomosis, while avoiding contact with a penetrating element or injury to an arterial structure 110 (e.g., the arterial structure 110 illustrated in FIG. 2) within the CP angle cistern 138.
  • an arterial structure 110 e.g., the arterial structure 110 illustrated in FIG. 2
  • the shunt delivery catheter 204 of the shunt delivery assembly 200 of FIG. 3 is navigated within the venous vasculature of patient from a venous access point until the penetrating element 210 is adjacent the target penetration site 140 in the IPS 102 (step 308) (FIG. 7A).
  • the endovascular CSF shunt device 250 is then distally advanced within the lumen of the shunt delivery catheter 204 via manipulation of the delivery wire 208 releasably secured to the endovascular CSF shunt device 250 until the distal protective element 276 is disposed adjacent the penetrating element 210 of the shunt delivery catheter 204 (step 310) (FIG. 7B).
  • the shunt delivery catheter 204 along with the endovascular CSF shunt device 250, is distally advanced, such that the penetrating element 210 pierces or penetrates through the venous sinus dura (in this case, the IPS wall 114) and the arachnoid layer 115 until reaching the CSF-filled SAS (in this case, the CP angle cistern 138), thereby creating an anastomosis 118 between the IPS 102 and the CP angle cistern 138 (step 312) (FIG. 7C).
  • the endovascular CSF shunt device 250 is distally advanced from the lumen of the shunt delivery catheter 204 via manipulation of the delivery wire 208 until the distal anchoring mechanism 266 is disposed within the CP angle cistern 138 (step 314) (FIG. 7D). Significantly, as the endovascular CSF shunt device 250 is deployed (i.e.
  • the distal protective element 276 is associated with the delivery wire 208 or shuttle or shroud, the distal protective element 276 will gently contact and deflect the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204 as the distal end of the delivery wire 208 or the shuttle or shroud enters the CP angle cistern 138.
  • the distal protective element 276 can also serve to maintain the opening(s) 272 at the distal body portion 256 of the endovascular CSF shunt device 250 patient and/or unobstructed from the arterial structure 110, such that the CSF within the CP angle cistern 138 drains through the endovascular CSF shunt device 250 into the venous system, via its openings 274, shunt lumen 258, and valve 260.
  • the distal anchoring mechanism 266 assumes the expanded or deployed configuration, thereby implanting the endovascular CSF shunt device 250 within the anastomosis 118 between the IPS 102 and CP angle cistern 138, while the distal protective element 276 continues to deflect the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204 (step 318) (FIG. 7E).
  • the endovascular CSF shunt device 250 is released from the delivery wire 208 is, and the shunt delivery assembly 200 (i.e., the delivery wire 208, guide catheter 202, and shunt delivery catheter 204) is removed from the patient, leaving the implanted endovascular CSF shunt device 250 in place (step 320) (FIG. 7F).
  • the shunt delivery assembly 200 i.e., the delivery wire 208, guide catheter 202, and shunt delivery catheter 204
  • the endovascular CSF shunt device 250 can be advanced distally within the lumen of the shunt delivery catheter 204 until the distal protective element 276 contacts the IPS wall 114. Upon further distal advancement of the shunt delivery catheter 204 and shunt device 250, the distal protective element 276 will linearly compress to allow the penetrating element 210 to contact and pierce the IPS wall 114.
  • the distal protective element 276 will follow the penetrating element 210 through the IPS wall 114 and arachnoid Iayer 115 (FIG. 7C).
  • the distal protective element 276 will linearly expand, such that the distal protective element 276 is distal to the penetrating element 210 within the CP angle cistern 138, thereby gently contacting and deflecting the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204 (FIG. 7D).
  • the method 300 instead comprises selecting an endovascular CSF shunt device having no distal protective element (step 306b).
  • the shunt delivery assembly 200 of FIG. 3 is then used to conventionally endovascularly create an anastomosis 118 between the IPS 102 and the CP angle cistern 138 and implant the selected endovascular CSF shunt device with no distal protective element within the anastomosis (step 322).
  • the method can be similar to the method described above with respect to FIGS. 7A-7F, with the exception that a distal protective element is not used to deflect an arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204.
  • FIGS. 8 and 9A-9F another exemplary method 300’ of endovascularly creating an anastomosis between the IPS 102 and the CP angle cistern 138 and implanting an endovascular CSF shunt device within the anastomosis, while avoiding contact or injury to an arterial structure 110 within the CP angle cistern 138 will now be described.
  • the method 300’ is similar to the method 300 described above with respect to FIGS.
  • the distal protective element 276 is affixed to the distal end of the shunt delivery catheter 204’ (or to a removable stylet (not shown) disposed within the lumen of the conventional shunt delivery catheter 204).
  • the method 350 first comprises evaluating the target implantation site 140 in the IPS 102 using one or more imaging systems (e.g., MRI, CT, cone-beam CT) (step 352), and confirming whether there are any CAS’s 160 (e.g., an arterial structure) proximate to the target implantation site 140 in the IPS wall 114 (step 354) in the same manner described above with respect to steps 302 and 304 of the method 300 illustrated in FIG. 6.
  • the method 300’ comprises selecting a shunt delivery catheter and/or stylet having a distal protective element 276 (e.g., shunt delivery catheter 204’ illustrated in FIG. 5D) (step 356a).
  • imaging of arterial structure 110, acquired prior to and/or during the index procedure can be used as a roadmap when performing subsequent steps of the method.
  • an anastomosis is then created between the IPS 102 and the CP angle cistern 138 and the selected endovascular CSF shunt device is implanted within the anastomosis, while avoiding contact with a penetrating element or injury to an arterial structure 110 (e.g., the arterial structure 110 illustrated in FIG. 2) within the CP angle cistern 138.
  • an arterial structure 110 e.g., the arterial structure 110 illustrated in FIG. 2
  • the distal protective element 276 is only used during the creation of the anastomosis between the IPS 102 and the CP angle cistern 138, and is then removed once (or even before if a stylet is used, for example, after shunt delivery catheter 204’ accesses CP angle cistern 138) the endovascular CSF shunt device 250 is deployed within anastomosis 118.
  • the shunt delivery catheter 204’ is navigated within the venous vasculature of patient from a venous access point until the penetrating element 210 is adjacent the target penetration site 140 in the IPS 102 (step 358) (FIG. 9A).
  • a microcatheter can be used over guidewire 206 and within the lumen of delivery catheter 204’ for additional support while navigating the delivery catheter to target penetration site 140.
  • a conventional shunt delivery catheter 204 can be navigated within the venous vasculature of the patient from the venous access point until the distal end of the shunt delivery catheter 204 is adjacent the target penetration site 140 in the IPS 102. Then, after removing the guidewire 206 (and, if used, the microcatheter), the stylet can be distally advanced within the lumen of the shunt delivery catheter 204 until the penetrating element 210 of the stylet is adjacent the target penetration site 140 in the IPS 102.
  • the shunt delivery catheter 204’ (or the conventional delivery catheter 204, along with the stylet) is distally advanced, such that the penetrating element 210 pierces or penetrates through the venous sinus dura (in this case, the IPS wall 114) and the arachnoid layer 115 until reaching the CSF- filled SAS (in this case, the CP angle cistern 138), thereby creating an anastomosis 118 between the IPS 102 and the CP angle cistern 138 (step 360).
  • the CSF- filled SAS in this case, the CP angle cistern 138
  • the distal protective element 276 will linearly compress to allow the penetrating element 210 to contact and pierce the IPS wall 114 (FIG. 9B). As the penetrating element 210 passes through the IPS wall 114 and arachnoid layer 115, the distal protective element 276 will follow the penetrating element 210 through the IPS wall 1 14 and arachnoid layer 115 (FIG. 9C).
  • the distal protective element 276 will linearly expand, such that the distal protective element 276 is distal to the penetrating element 210 within the CP angle cistern 138, thereby gently contacting and deflecting the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204’ (step 362) (FIG. 9D)
  • an endovascular CSF shunt device 250’ having no distal protective element e.g., any of the endovascular CSF shunt devices described U.S. Patent Nos. 10,272,230 and 10,765,846 and U.S. Patent Publication No. 2020/0030588
  • distal protective element e.g., any of the endovascular CSF shunt devices described U.S. Patent Nos. 10,272,230 and 10,765,846 and U.S. Patent Publication No. 2020/0030588
  • the stylet will be removed from the lumen of the conventional shunt delivery catheter 204 prior to distal advancement of the CSF shunt device 250’ within the lumen of conventional shunt delivery catheter 204’.
  • the distal anchoring mechanism 266 of the endovascular CSF shunt device 250’ can gently contact and further deflect the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204’ (or alternatively the distal end of the conventional shunt delivery catheter 204).
  • an endovascular CSF shunt device 250 having a distal protective element 276 e.g., any one of the endovascular CSF shunt devices 250 illustrated in FIGS. 4A-4B and 5A-5C), or alternatively, a shunt delivery wire or shroud having a distal protective element
  • a shunt delivery wire or shroud having a distal protective element can be optionally distally advanced through the lumen of the shunt delivery catheter 204’ (or the lumen of the conventional shunt delivery catheter 204 after removal of the stylet) and deployed within the anastomosis 118, with the associated advantages described above with respect to the method 300.
  • the distal anchoring mechanism 266 assumes the expanded or deployed configuration, thereby implanting the endovascular CSF shunt device 250’ within the anastomosis 118 between the IPS 102 and CP angle cistern 138 (step 366) (FIG. 9F). If the distal protective element 276 constrains the distal anchoring mechanism 266, the shunt delivery catheter 204’, along with the distal protection element 276, can be proximally withdrawn somewhat to allow the distal anchoring mechanism 266 to assume the expanded or deployed configuration.
  • the conventional shunt delivery catheter 204 along with the stylet, is used to deliver the endovascular CSF shunt device 250’
  • the distal protective element 276 will have been previously removed with the stylet.
  • the delivery wire 208, guide catheter 202, and shunt delivery catheter 204’ (or conventional shunt delivery catheter 204) is removed from the patient, leaving the implanted endovascular CSF shunt device 250’ in place (step 368) (FIG. 9G).lf at step 354, an arterial structure 110 is not adjacent the target implantation site in the IPS wall 114, the method 300 instead comprises selecting an endovascular CSF shunt device having no distal protective element (step 356b).
  • step 370 is then used to conventionally endovascularly create an anastomosis 1 18 between the IPS 102 and the CP angle cistern 138 and implant an endovascular CSF shunt device within the anastomosis 118 (step 370).
  • the method can be similarto the method described above with respect to FIGS. 9A-9G, with the exception that a distal protective element is not used to deflect an arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204.
  • the shunt delivery assembly 200’ is similar to the shunt delivery assembly 200 illustrated in FIG. 3, with the exception that the shunt delivery assembly 200’ further comprises an additional guide catheter 202’, and an additional delivery catheter 204” coaxially disposed within and movable relative to a lumen (not shown) of the additional guide catheter 202’.
  • the shunt delivery assembly 200’ can also comprise an additional guidewire 206’ coaxially disposed within the additional guide catheter 202’ and/or additional delivery catheter 204”.
  • the additional guide catheter 202’, additional delivery catheter 204”, and additional guidewire 206’ can be similarly constructed as the guide catheter 202, shunt delivery catheter 204, guidewire 206 illustrated in FIG. 3, with the exception that the additional delivery catheter 204” does not include a penetrating element 210.
  • the additional delivery catheter 204” is dimensioned to percutaneously reach the arterial structure 110 from an arterial access location in the patient (e.g., femoral artery, brachial artery, subclavian artery, carotid artery).
  • the shunt deliver assembly 200’ further comprises a magnetized insert 218 coaxially disposed within and movable relative to a lumen (not shown) of the additional delivery catheter 204”.
  • the magnetized insert 218 comprises an elongate shaft 220 (e.g., a wire, catheter, or the like) and a magnetic element 222 affixed to the distal end of the elongate shaft 220.
  • the magnetic element 222 can be, e.g., a permanent magnet or an electromagnet that can be selectively activated/deactivated.
  • the shunt delivery assembly 200’ comprises a shunt delivery catheter 204’” that is similar to the shunt delivery catheter 204 illustrated in FIG.
  • the shunt delivery catheter 204 further comprises a distal magnetic protective element 276’ affixed to the distal end of the shunt delivery catheter 204 adjacent the penetrating element 210.
  • the distal magnetic protective element 276’ can be affixed to the distal end of the shuttle, shroud or delivery wire 208 configured for delivering the endovascular CSF shunt device 250 from the shunt delivery catheter 204.
  • the magnetized insert 218 can be introduced within the arterial structure 110, while the distal magnetic protective element 276’ of the shunt delivery catheter 204’” is introduced in the IPS 102, such that, when the penetrating element 210 pierces or penetrates through the IPS wall 114 and arachnoid layer 115 into the CP angle cistern 138 to create the anastomosis between the IPS 102 and CP angle cistern 138, the same poles of the distal magnetic protective element 276’ of the shunt delivery catheter 204’” and the magnetic element 222 of the magnetized insert 218 disposed within the arterial structure 110 repel each other, such that the arterial structure 1 10 is deflected away from the penetrating element 210.
  • the endovascular CSF shunt device can carry a magnetic element.
  • an endovascular CSF shunt device 250’ is similar to the CSF shunt device 250 illustrated in FIGS.
  • the endovascular CSF shunt device 250’ comprises a distal magnetic protective element 276’ that magnetically deflects the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204.
  • the distal magnetic protective element 276’ takes the form of a magnet, which can be a permanent magnet or an electromagnet that can be selectively activated/deactivated.
  • the distal magnetic protective element 276’ is affixed to the distal end of the distal anchoring mechanism 266, although in alternative embodiments, the distal magnetic protective element 276’ can be located at any distal portion of the endovascular CSF shunt device 250’ that will magnetically react with the magnetic element 222 of the magnetized insert 218 when the endovascular CSF shunt device 250’ is disposed in the IPS 102 and the magnetic element 222 is disposed in the arterial structure 110.
  • the distal magnetic protective element 276’ can be affixed to the shunt body 252 just proximal to the distal anchoring mechanism 266.
  • FIG. 12 and 13A-13G another exemplary method 400 of endovascularly creating an anastomosis between the IPS 102 and the CP angle cistern 138 and implanting an endovascular CSF shunt device within the anastomosis, while avoiding contact or injury to an arterial structure 110 within the CP angle cistern 138 will now be described.
  • the method 400 first comprises evaluating the target implantation site 140 in the IPS 102 using one or more imaging systems (e.g., MRI, CT, cone-beam CT) (step 402), and confirming whether there are any CAS’s 160 (e.g., an arterial structure) proximate to the target implantation site 140 in the IPS wall 114 (step 404) in the same manner described above with respect to steps 302 and 304 of the method 300 illustrated in FIG. 6. If an arterial structure 110 is adjacent the target penetration site 140 in the IPS wall 114, the method 400 further comprises selecting a shunt delivery catheter having a distal magnetic protective element (e.g., the shunt delivery catheter 204”’ illustrated in FIG.
  • a shunt delivery catheter having a distal magnetic protective element e.g., the shunt delivery catheter 204”’ illustrated in FIG.
  • a shunt delivery wire or shroud having a distal magnetic protective element (step 406a).
  • an endovascular CSF shunt device having a distal magnetic protective element e.g., the endovascular CSF shunt device 250’ illustrated in FIGS. 11A-11 B
  • an endovascular CSF shunt device having a distal magnetic protective element can be selected.
  • An anastomosis is then created between the IPS 102 and the CP angle cistern 138 and the selected endovascular CSF shunt device is implanted within the anastomosis, while avoiding contact or injury to an arterial structure 110 (e.g., the arterial structure 1 10 illustrated in FIG. 2) within the CP angle cistern 138.
  • an arterial structure 110 e.g., the arterial structure 1 10 illustrated in FIG. 2
  • the shunt delivery catheter 204’” of the shunt delivery assembly 200’ of FIG. 10 is navigated within the venous vasculature of the patient from a venous access point until the penetrating element 210 and distal magnetic protective element 276’ are adjacent the target penetration site in the IPS 102 (step 408) (FIG. 13A).
  • an endovascular CSF shunt device e.g., an endovascular CSF shunt device 250” with no distal protective element
  • an endovascular CSF shunt device 250 is then distally advanced within the lumen of the shunt delivery catheter 204 via manipulation of the delivery wire 208 releasably secured to the endovascular CSF shunt device 250” until the anchoring mechanism is disposed adjacent the penetrating element 210 of the shunt delivery catheter 204”’ (step 410) (FIG. 13B-1 ).
  • the shunt delivery catheter 204 of the shunt delivery assembly 200 of FIG. 3 instead of the shunt delivery catheter 204’” of the shunt delivery assembly 200’ of FIG. 10, can be navigated within the venous vasculature of the patient from a venous access point until the penetrating element 210 is adjacent the target penetration site in the IPS 102.
  • the endovascular shunt device 250’ with the distal magnetic protective element 276’ can then be distally advanced within the lumen of the shunt delivery catheter 204 via manipulation of the delivery wire 208 until the distal anchoring mechanism 266 and distal magnetic protective element 276’ are disposed adjacent the penetrating element 210 of the shunt delivery catheter 204 (FIG. 13B-2).
  • the magnetic element 222 of the magnetized insert 218 of the shunt delivery assembly 200’ of FIG. 10 is disposed within the arterial structure 110.
  • the additional delivery catheter 204” of the shunt delivery assembly 200’ of FIG. 10 is navigated within the arterial vasculature (in the case where CAS is the arterial structure 110) of the patient from an arterial access point until the distal end of the additional delivery catheter 204” is within the arterial structure 110 (step 412) (not shown).
  • the magnetized insert 218 is distally advanced within the lumen of the additional delivery catheter 204” via manipulation of the elongate shaft 220 coupled to the magnetic element 222 until the magnetic element 222 is adjacent or proximate the intended trajectory of the penetrating element 210, e.g., within the lumen of delivery catheter 204” or deployed outside of the additional delivery catheter 204” within the arterial structure 110’ (step 414) (FIG. 13C).
  • the close proximity between the same poles of the distal magnetic protective element 276’ of the shunt delivery catheter 204’” and the magnetic element 222 of the magnetized insert 218 disposed in the arterial structure 110 creates a repelling force (shown by arrow), thereby deflecting the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204’” (step 418).
  • the shunt delivery catheter 204” and the magnetized insert 218 can be physically oriented relative to each other to ensure that the same poles of the distal magnetic protective element 276’ and the magnetic element 222 create a repelling force by confirming, under medical imaging (e.g., ultrasonography or radiography), that the distal end of the magnetized insert 218 is deflecting away from the distal end of the shunt delivery catheter 204’”.
  • medical imaging e.g., ultrasonography or radiography
  • the penetrating element 210 pierces or penetrates through the venous sinus dura (in this case, the IPS wall 114) and the arachnoid layer 115 until reaching the CSF-filled SAS (in this case, the CP angle cistern 138), thereby creating an anastomosis 118 between the IPS 102 and the CP angle cistern 138 (FIG. 13D-2).
  • the penetrating element 210 pierces or penetrates through the IPS wall 114 and arachnoid layer 115, the close proximity between the distal magnetic protective element 276’ of the endovascular CSF shunt device 250’ and the magnetic element 222 of the magnetized insert 218 disposed in the arterial structure 110 create a repelling force (shown by arrow), thereby deflecting the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204.
  • the repelling force between the distal magnetic protective element 276’ of the shunt delivery catheter 204” and the magnetic element 222 of the magnetized insert 218 will tend to deflect the arterial structure 110 away from the penetrating element 210 during, and perhaps even prior to, the creation of the anastomosis 118, thereby ensuring that the arterial structure 110 is not damaged as the penetrating element 210 pierces or penetrates through the IPS wall 114 and arachnoid layer 115 into the CP angle cistern 138.
  • the endovascular CSF shunt device 250 is deployed within the anastomosis 118 by distally advancing it within the lumen of the shunt delivery catheter 204’” via manipulation of the delivery wire 208 (or alternatively the endovascular CSF shunt device 250’ is deployed within the anastomosis 1 18 by distally advancing it within the lumen of the shunt delivery catheter 204 via manipulation of the delivery wire 208) until the distal anchoring mechanism 266 is disposed within the CP angle cistern 138 (step 420) (FIG. 13E).
  • an endovascular CSF shunt device with a protective element designed to physically contact the arterial structure 1 10 can be selected at step 406a) and distally advanced within the lumen of the of the shunt delivery catheter 204” via manipulation of the delivery wire 208’ until the distal anchoring mechanism 266 is disposed within the CP angle cistern 138.
  • the distal protective element 276 can gently contacts and further deflect the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204.
  • the distal anchoring mechanism 266 assumes the expanded or deployed configuration, thereby anchoring the endovascular CSF shunt device 250” (or alternatively the endovascular CSF shunt device 250 or endovascular CSF shunt device 250’) within the anastomosis 118 between the IPS 102 and CP angle cistern 138, while the magnetic repelling force created between the distal magnetic protective element 276’ of the shunt delivery catheter 204” and the magnetic element 222 of the magnetized insert 218 continues to magnetically deflect the arterial structure 110 away from the penetrating element 210 of the shunt delivery catheter 204” (FIG.
  • the endovascular CSF shunt device 250 (or alternatively the endovascular CSF shunt device 250 or the endovascular CSF shunt device 250’) is firmly implanted within the anastomosis 118 between the IPS 102 and CP angle cistern 138, the endovascular CSF shunt device 250” (or alternatively the endovascular CSF shunt device 250 or the endovascular CSF shunt device 250’) is released from the delivery wire 208 is , the shunt delivery assembly 200’ (i.e., the guide catheter 202, additional guide catheter 202’, shunt delivery catheter 204’”, additional delivery catheter 204”, and magnetized insert 218) is removed from the patient, leaving the implanted endovascular CSF shunt device 250” (or alternatively, the endovascular CSF shunt device 250 or the endovascular CSF shunt device 250’) in place (FIG. 11G)
  • the method 400 instead comprises selecting shunt delivery catheter having no distal magnetic protective element (step 406b of FIG. 12).
  • the shunt delivery assembly 200 of FIG. 3 is then used to conventionally endovascularly create an anastomosis 118 between the IPS 102 and the CP angle cistern 138 and implant an endovascular CSF shunt device within the anastomosis 118 (step 422).
  • the method can be similar to the method described above with respect to FIGS. 11A-11G, with the exception that the magnetic elongate member 218 is not disposed within the arterial structure 110, and thus, not deflected away from the penetrating element of the shunt delivery catheter.
  • a medical system 200 comprises a medical tool 205 and the aforementioned magnetized insert 218 and associated guide catheter 202’, delivery catheter 204”, and optional guidewire 206’.
  • the medical tool 205 can be any tool capable of accessing an internal region of the patient via a target penetration site.
  • the medical tool 205 can be an intravascular catheter (with or without a stylet) or a percutaneous needle.
  • the medical tool 205 comprises an elongate member 207 and an operative element 209 (therapeutic and/or diagnostic) disposed on the distal tip of the elongate member 207.
  • the operative element 209 can be a delivery port associated with a lumen through which a medical element (e.g., the CSF shunt device described above) or substance can be delivered to the internal region of the patient.
  • the operative element 209 can be a biopsy port (with or without a cutting element) through which a tissue sample from the internal region of the patient can be extracted.
  • the operative element 209 can be an imaging element (e.g., ultrasound, optical, etc.), e.g., for providing structural or functional imaging.
  • the medical tool 205 comprises a penetrating element 210.
  • the medical tool 205 comprises an intravascular catheter (with or without a stylet)
  • the penetrating element 210 can be disposed at the distal tip of the intravascular catheter or the distal tip of the stylet.
  • the medical tool 205 comprises a needle
  • the penetrating element 210 can be disposed at the distal tip of the needle.
  • the anatomical structure to be physically manipulated can be, e.g., a blood vessel, in which case, the magnetized insert 218 can be i ntralum inal ly delivered by the delivery catheter 204” within the anatomical structure via the vasculature of the patient, or can be a gastrointestinal anatomical structure, in which case, the magnetized insert 218 can be intraluminally delivered by the delivery catheter 204” via the gastrointestinal tract of the patient.
  • a magnetic element 213 can be physically associated with the distal end of the medical tool 205 (e.g., by being affixed to the distal end of the medical tool 205, itself, or affixed to the distal end of another medical device carried by the medical tool 205 (e.g., a medical device to be delivered by the medical tool 205)), such that, when the medical tool 205 has accessed the internal region of the patient via the target penetration site and the magnetized insert 218 has accessed the anatomical structure, the magnetic element 213 physically associated with the distal end of the medical tool 205 and the magnetic element 222 of the magnetized insert 218 are configured for interacting with each other in a manner that deflects the anatomical structure relative to the distal tip of the medical tool 205.
  • the magnetic element 213 physically associated with the distal end of the medical tool 205 can function as a protective magnetic element.
  • the same poles of the protective magnetic element 213 and the magnetic element 222 of the magnetized insert 218 can repel each other, such that the anatomical structure is deflected away from the distal tip of the medical tool 205 (e.g., away from the penetrating element 210).
  • the magnetic element 213 physically associated with the distal end of the medical tool 205 can function to facilitate such treatment and/or diagnosis of the anatomical structure by the medical tool 205.
  • opposite poles of the magnetic element 213 physically associated with the distal end of the medical tool 205 and the magnetic element 222 of the magnetized insert 218 can attract each other, such that the anatomical structure is deflected toward the distal tip of the medical tool 205 (e.g., toward the penetrating element 210 or operative element 209).
  • FIG. 15 one method 450 of performing a medical procedure (e.g., a therapeutic procedure or a diagnostic procedure) on a patient using the medical system 200” of FIG. 14 will be described.
  • a medical procedure e.g., a therapeutic procedure or a diagnostic procedure
  • the anatomical structure is intraluminally accessed with the delivery catheter 204” (step 452).
  • the delivery catheter 204 with the aid of the guide catheter 202’ and guide wire 206’, can be navigated within the vasculature of the patient from a venous or arterial access point until the distal end of the additional delivery catheter 204” is within the anatomical structure.
  • the delivery catheter 204 (with or without the aid of a guide catheter 202’ and/or guide wire 206’), can be navigated within the gastro-intestinal tract of the patient from an access point via an access point (e.g., mouth or anus).
  • the magnetic element 222 of the magnetized insert 218 is then disposed within the anatomical structure via the delivery catheter 204” (step 454).
  • the magnetized insert 218 can be distally advanced within the lumen of the additional delivery catheter 204” via manipulation of the elongate shaft 220 coupled to the magnetic element 222 until the magnetic element 222 is within the anatomical structure adjacent or proximate the intended trajectory of the distal tip of the medical tool 205.
  • An internal region of the patient is then accessed with the medical tool 205 (step 456).
  • the manner in which the internal region of the patient is accessed will depend on the medical procedure to be performed.
  • the internal region of the patient can be intraluminally or endoluminally accessed, in which case, the medical tool 205 can comprise a flexible catheter.
  • such access can be intravascular or endovascular in nature, in which case, the flexible catheter 205 can be introduced into the vasculature of the patient via a venous or arterial access point.
  • such access can be made through other lumens in the patient, e.g., the gastro-intestinal tract, in which case, the flexible catheter 205 can be introduced into the gastro-intestinal tract of the patient via access point (e.g., mouth or anus).
  • the internal region of the patient can be percutaneously accessed (optionally under guidance of ultrasound), in which case, the medical tool 205 can comprise a percutaneous needle.
  • percutaneous access 205 can be made, e.g., within the abdomen or thorax of the patient.
  • the magnetic element 213 is disposed within the internal region of the patient (step 458). It should be appreciated that, since the magnetic element 213 is affixed to the distal tip of the medical tool 205, the magnetic element 213 will necessarily be disposed within the internal region of the patient as the internal region of the patient is accessed by the medical tool 205. In alternative methods, the magnetic element 213 can be disposed within the internal region of the patient using other means. For example, the magnetic element 213 can be affixed to another medical device delivered by the medical tool 205, in which case, the magnetic element 213 can be disposed within the internal region of the patient once such other medical device is delivered into the interior region of the patient.
  • the anatomical structure is magnetically deflected relative to the distal tip of the medical tool 205 via interaction between the magnetic elements 213, 222 (due to their close proximity) (step 460).
  • the anatomical structure is deflected away from the distal tip of the medical tool 205 or deflected toward the distal tip of the medical tool 205 will depend on the nature of the treatment and/or diagnosis of the patient.
  • the same poles of the magnetic element 213 physically associated with the medical tool 205 and the magnetic element 222 of the magnetized insert 218 can repel each other, such that the anatomical structure is deflected away from the distal tip of the medical tool 205.
  • the medical tool 205 and the magnetized insert 218 can be physically oriented relative to each other to ensure that the same poles of the magnetic elements 213, 222 create a magnetic repelling force by confirming, under medical imaging (e.g., ultrasonography or radiography), that the distal bend of the magnetized insert 218 is deflecting away from the distal end of the medical tool 205.
  • medical imaging e.g., ultrasonography or radiography
  • the different poles of the magnetic element 213 physically associated with the medical tool 205 and the magnetic element 222 of the magnetized insert 218 can attract each other, such that the anatomical structure is deflected toward the distal tip of the medical tool 205.
  • the medical tool 205 and the magnetized insert 218 can be physically oriented relative to each other to ensure that the different poles of the magnetic elements 213, 222 create a magnetic attraction force by confirming, under medical imaging (e.g., ultrasonography or radiography), that the distal end of the magnetized insert 218 is deflecting toward the distal end of the medical tool 205.
  • the medical tool 205 can then be operated to perform a medical procedure on the patient (step 462).
  • the medical tool 205 can deliver a medical device or substance to the interior region and/or anatomical structure, acquire a biopsy from the interior region and/or anatomical structure, image the interior region and/or anatomical structure, etc.
  • the medical procedure can be performed on the patient by the medical tool while the anatomical structure continues to be magnetically deflected relative to the interior region.
  • the medical tool 205 takes the form of a needle having a penetrating element 210.
  • the anatomical structure 219 is adjacent or proximate the intended trajectory of the penetrating element 210 that is to be percutaneously introduced into the interior region 217.
  • FIG. 16A the anatomical structure 219 is adjacent or proximate the intended trajectory of the penetrating element 210 that is to be percutaneously introduced into the interior region 217.
  • the magnetized insert 218, along with the magnetic element 222 can be introduced into the anatomical structure 219, such that the magnetic element 222 of the magnetized insert 218 is also adjacent or proximate the intended trajectory 221 of the penetrating element 210 of the needle 205.
  • the needle 205, along with the magnetic element 213, can be percutaneously introduced into the interior region 217.
  • the same poles of the magnetic elements 213, 222 create a magnetic repelling force that deflects the magnetized insert 218, and thus the anatomical structure 219 in which it is disposed, away from the distal tip of the needle 205.
  • the needle 205 can then be operated to perform a medical procedure within the interior region 217 of the patient.
  • the medical tool 205 takes the form of a needle having a penetrating element 210, and the anatomical structure 219 is adjacent or proximate the intended trajectory of the penetrating element 210 that is to be percutaneously introduced into the interior region 217.
  • anatomical structure 219 e.g., a blood vessel or a gastrointestinal organ
  • the magnetized insert 218, along with the magnetic element 222 can be introduced into the anatomical structure 219, such that the magnetic element 222 of the magnetized insert 218 is also adjacent or proximate the intended trajectory of the penetrating element 210 of the needle 205.
  • the needle 205, along with the magnetic element 213, can be percutaneously introduced into the interior region 217.
  • the magnetic element 213 of the needle 205 comes in close proximity to the magnetic element 222 of the magnetized insert 218, the different poles of the magnetic elements 213, 222 create a magnetic attraction force that deflects the magnetized insert 218, and thus the anatomical structure 219 in which it is disposed, toward the distal tip of the needle 205.
  • FIG. 17A the magnetized insert 218, along with the magnetic element 222, can be introduced into the anatomical structure 219, such that the magnetic element 222 of the magnetized insert 218 is also adjacent or proximate the intended trajectory of the penetrating element 210 of the needle 205.
  • the anatomical structure 219 is now in a more advantageous position (i.e., the depth required to access the anatomical structure 219 by the needle 205 will be substantially decreased) to facilitate introduction of the needle 205 into the anatomical structure 219.
  • the needle 205 can then be operated to perform a medical procedure within the anatomical structure 219 of the patient.
  • FIGS. 18A-18B illustrate exemplary procedures to treat subdural hematomas, according to embodiments of the disclosed inventions.
  • blood collects on the surface of the brain due to a head injury or other cause that burst blood vessels forming a pool of blood (e.g., subdural hematoma 165).
  • the subdural hematoma 165 can press against the brain and damage tissue, which can be symptomatic for patients including a medical emergency and a life-threatening event.
  • the subdural hematoma 165 is disposed near, adjacent or proximate the dural venous sinuses including, but not limited to, the target deployment site of the embodiments previously described (e.g., FIG.
  • the delivery catheter 204 having the penetrating element 210 can pierce or penetrate the upper IPS wall 114a, as shown in FIG. 18A.
  • suction is applied by the delivery catheter 204 to drain the pool of blood or subdural hematoma 165, as shown in FIG. 18A by arrows (ii).
  • the delivery catheter 204 can introduce or deliver vaso-occlusive devices 1 17 (e.g., coils, microspheres), liquid embolic or their like, to occlude the subdural hematoma 165 when the subdural hematoma 165 is drained, as shown in FIG. 18B.
  • FIGS. 19A-19D illustrate an exemplary fastening member of an alternative embodiment of the delivery catheter 204 of the disclosed inventions.
  • FIG. 19C is a down-the-barrel view of the delivery catheter 204, the delivery catheter 204 comprises a delivery catheter lumen 305 and a pair of fastening members or arms 346 disposed at the distal portion 344 of the catheter.
  • the delivery catheter 204 is coaxially disposed within the outer tubular member 202 (i.e., guide catheter) of the delivery assembly 200 (FIG. 3), and the pair of arms 346 of the delivery catheter 204 are in a delivery configuration (e.g., radially constrained by guide catheter 202).
  • the delivery catheter 204 moves relative to the guide catheter 202, such that when the distal portion 344 of the delivery catheter 204 is disposed outside the guide catheter 202 (as shown in FIG. 19B) the pair of arms 346 expand radially outwards into a deployed configuration, so as to engage arachnoid layer 115 and secure the distal end portion of delivery catheter 204 in the SAS 116 (FIG. 19D).
  • the pair of arms 346 When deployed (FIGS. 19B-19D), the pair of arms 346 are biased to exert an outward radial force that engages and secures the delivery catheter 204 within the SAS 116 and against arachnoid layer 115.
  • the pair of arms 346 can include spikes, burrs, barbs or other features to engage the arachnoid layer 115.

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Abstract

Un système de dérivation comprend un dispositif de dérivation endovasculaire, un cathéter de pose de dérivation comprenant une lumière conçue pour loger le dispositif de dérivation endovasculaire, un élément de pénétration conçu pour percer ou pénétrer à travers une paroi d'un récipient dans un espace extravasculaire afin de créer une anastomose à l'intérieur de la paroi du vaisseau, et un élément de protection distal atraumatique conçu pour dévier une structure anatomique critique (CAS) se trouvant à l'intérieur de l'espace extravasculaire à l'opposé de l'élément de pénétration.
PCT/US2025/026277 2024-04-29 2025-04-24 Systèmes pour procédures minimalement invasives dans des espaces extravasculaires Pending WO2025230817A1 (fr)

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