Devices and methods for accessing the intradural compartment and treating intracranial hematoma

Abstract

Devices and methods are described for a minimally invasive procedure offering immediate relief of brain compression and prevention of subdural hematoma re-accumulation. For example, this disclosure describes devices and methods for embolization of bleeding branch vessels of the middle meningeal artery and subdural hematoma drainage in a single endovascular intervention using multimodal catheter-based technology.

What is claimed is: 
     
         1 . An apparatus, comprising:
 a catheter having a proximal end and a distal end and defining a lumen therebetween, the distal end of the catheter configured to be disposed within an intracranial blood vessel of a subject; and   a shaft slidably disposed within the lumen, the shaft including a distal tip portion configured to be advanced distal to the distal end of the catheter, the distal tip portion including a perforating element configured to penetrate through a wall of the blood vessel and dura to be disposed in an extravascular space,   the distal tip portion of the shaft configured to transition from a radially constrained configuration in which the perforating element is distally positioned to penetrate through the wall of the blood vessel and the dura to a curved configuration when unconstrained in the extravascular space.   
     
     
         2 . The apparatus of  claim 1 , wherein the catheter is configured to be advanced over at least a portion of the shaft and into the extravascular space, the catheter further configured to couple to a vacuum source that can apply a vacuum to the lumen to remove fluids and matter from the extravascular space. 
     
     
         3 . The apparatus of  claim 1 , wherein the atraumatic shape is a J shape or a U shape. 
     
     
         4 . The apparatus of  claim 1 , wherein the perforating element includes an energy element configured to generate ablation energy to penetrate through the wall of the blood vessel and the dura. 
     
     
         5 . The apparatus of  claim 1 , wherein a portion the perforating element has a non-circular cross-sectional shape. 
     
     
         6 . The apparatus of  claim 1 , wherein the perforating element includes a cutting bevel configured to penetrate through the wall of the blood vessel and the dura. 
     
     
         7 . The apparatus of  claim 1 , wherein the blood vessel is the middle meningeal artery, and the penetrating element is configured to penetrate through the wall of the middle meningeal artery (MMA) and the dura and reach the intracranial extravascular space. 
     
     
         8 . The apparatus of  claim 1 , further comprising a hemostatic element configured to close an arteriotomy in the blood vessel formed by the penetrating element,
 the catheter being configured to deliver the hemostatic element to close the arteriotomy.   
     
     
         9 . An apparatus, comprising:
 a catheter having a proximal end and a distal end and defining a lumen therebetween, the distal end of the catheter configured to be disposed within a blood vessel of a subject;   a shaft slidably disposed within the lumen, the shaft including a distal tip portion configured to be advanced distal to the distal end of the catheter; and   an energy element disposed at a distal end of the distal tip portion, the energy element configured to generate radiofrequency (RF) energy to penetrate through a wall of the blood vessel and dura,   after the energy element has penetrated through the wall of the blood vessel and the dura, the distal tip portion of the shaft and the distal end of the catheter configured to be positioned in an intracranial extravascular space,   the proximal end of the catheter being configured to couple to a vacuum source that can apply a vacuum to the lumen to remove fluids and matter from the extravascular space.   
     
     
         10 . The apparatus of  claim 9 , wherein the distal tip portion of the shaft is configured to transition from a radially constrained configuration in which the energy element is distally positioned to generate RF energy to penetrate through the wall of the blood vessel and the dura to a curved configuration in which the energy element is curved back toward the shaft. 
     
     
         11 . The apparatus of  claim 9 , wherein the energy element includes a single electrode configured to generate the RF energy. 
     
     
         12 . The apparatus of  claim 9 , wherein the energy element includes two or more electrodes configured to generate the RF energy in a monopolar or bipolar mode. 
     
     
         13 . The apparatus of  claim 9 , further comprising a temperature sensor disposed on the distal tip portion of the shaft and configured to monitor a temperature of tissue at or near a site of the penetration. 
     
     
         14 . The apparatus of  claim 9 , further comprising one or more electrodes configured to monitor an impedance or a permittivity value of tissue and fluids. 
     
     
         15 . The apparatus of  claim 9 , further comprising a pressure sensor disposed on the distal tip portion of the shaft and configured to monitor at least one of: a contact pressure between the energy element and tissue, or a pressure of fluid surrounding the energy element. 
     
     
         16 . The apparatus of  claim 9 , wherein the blood vessel is the middle meningeal artery, and the energy element is configured to penetrate through the wall of the middle meningeal artery (MMA) and the dura and reach the intracranial extravascular space. 
     
     
         17 . The apparatus of  claim 9 , wherein the blood vessel is the middle meningeal artery, and the energy element is configured to deliver RF energy to close a transvascular passageway and a vascular lumen of the MMA and obtain hemostasis. 
     
     
         18 . The apparatus of  claim 9 , wherein the catheter is further configured to deliver one or more of: a device, a therapeutic agent, or a fluid into the extravascular space. 
     
     
         19 . A system, comprising:
 a radiofrequency (RF) generator configured to generate RF energy;   a RF device including a distal portion including an energy element, the energy element configured to be operatively coupled to the RF generator to receive the RF energy and to apply the RF energy to penetrate through a wall of a blood vessel and dura of a subject, the distal portion of the RF ablation device configured to be advanced extravascularly after the energy element has penetrated through the wall of the blood vessel and the dura; and   an aspiration catheter defining a lumen, the aspiration catheter configured to be advanced over at least a portion of the RF device and into the extravascular intracranial space.   
     
     
         20 . The system of  claim 19 , wherein the proximal end of the catheter is configured to couple to a vacuum source that can apply a vacuum to the lumen to remove the fluids and matter from the extravascular space. 
     
     
         21 . The system of  claim 19 , wherein the RF generator is configured to generate the RF energy in the form of a pulse waveform including a series of RF pulses. 
     
     
         22 . The system of  claim 21 , further comprising a temperature sensor disposed at or near the distal portion of the RF ablation device and configured to monitor a temperature of tissue at or near a site of the penetration,
 the RF generator configured to modulate one or more parameters of the pulse waveform based on a temperature signal received from the temperature sensor.   
     
     
         23 . The system of  claim 21 , further comprising one or more electrodes configured to monitor an impedance or a permittivity value of tissue and fluids,
 the RF generator configured to modulate one or more parameters of the pulse waveform based on the impedance or the permittivity value received from the one or more electrodes.   
     
     
         24 . The system of  claim 23 , wherein the one or more parameters include at least one of: a duration, a voltage magnitude, a duty cycle, or a pulse width of the pulses of RF energy. 
     
     
         25 . The system of  claim 19 , further comprising a pressure sensor disposed at or near the distal portion of the RF ablation device and configured to monitor at least one of: a contact pressure between the energy element and tissue, or a pressure of fluid surrounding the energy element,
 the RF generator configured to activate the generation of the RF energy or to terminate generation of the RF energy based on a pressure signal received from the pressure sensor.   
     
     
         26 . The system of  claim 19 , wherein the energy element includes a single electrode configured to apply the RF energy in a monopolar mode. 
     
     
         27 . The system of  claim 19 , wherein the energy element includes two or more electrodes configured to apply the RF energy in a monopolar or bipolar mode. 
     
     
         28 . A method, comprising:
 extending a distal tip portion of a shaft disposed within a lumen of a catheter distal to a distal end of the catheter, the distal end of the catheter being disposed within an intracranial vessel of a subject;   creating an opening in a wall of the vessel and dura using a penetrating element disposed on the distal tip portion of the shaft;   advancing the distal tip portion of the shaft into the extravascular space and toward a subdural hematoma, the distal tip portion of the shaft acquiring a curve when unconstrained in the extravascular space; and   advancing the catheter over at least a portion of the shaft and into the subdural hematoma; and   applying suction to the lumen of the catheter to remove fluid from the subdural hematoma after the catheter is positioned within the subdural hematoma and the shaft removed.   
     
     
         29 . The method of  claim 28 , further comprising, after applying suction to remove the fluid from the subdural hematoma:
 retracting the catheter back toward the opening created in the wall of the artery; and   delivering, via the lumen of the suction catheter, a hemostatic element or a radiofrequency device to close the opening or vascular lumen.   
     
     
         30 . The method of  claim 28 , further comprising injecting, using the catheter, an embolic material to embolize an artery to prevent further development of the subdural hematoma.