Rapid aspiration thrombectomy system and method
An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath. The system includes an aspiration or support catheter having a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion. The catheter has a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom. The system includes a dilator having a flexible, distal dilator portion sized to be received within the lumen of the luminal portion. Associated systems, devices, and methods of use are also described.
1 . A method of performing a medical procedure in a cerebral vessel of a patient, the method comprising:
advancing, while assembled, a catheter system, as a single unit over a guidewire distal to a petrous portion of an internal carotid artery to a cerebral vessel, the catheter system comprising:
a catheter comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end; and
a catheter advancement element comprising a proximal end region, a distal tip having a taper, and a lumen that communicates with a distal opening in fluid communication with the cerebral vessel, wherein the proximal end region extends proximally outside of the body of the patient,
wherein, when assembled, at least a portion of the catheter advancement element is located within the lumen of the catheter, at least a portion of the distal tip is located distal to the distal end of the catheter, and a proximal end of the catheter advancement element is locked with the proximal end of the catheter by a mechanical locking element,
wherein the distal tip of the catheter advancement element is more flexible than the distal end of the catheter to form a smooth transition in flexibility between (1) a flexibility of the distal end of the catheter and (2) a flexibility of the guidewire extending outside the distal opening;
reaching a target site within the cerebral vessel with the distal end of the catheter;
unlocking the catheter advancement element from the proximal end of the catheter;
withdrawing the catheter advancement element from the lumen of the catheter; and
removing occlusive material while applying a negative pressure to the lumen of the catheter to capture the occlusive material at, within, or through the distal end of the catheter.
2 . The method of claim 1 , wherein an outer diameter of the catheter advancement element is about 0.070″.
3 . The method of claim 2 , wherein an inner diameter of the catheter is about 0.072″.
4 . The method of claim 1 , wherein the catheter advancement element has an inner diameter of between 0.020″ and about 0.024″ and is sized to receive the guidewire, wherein the guidewire has an outer diameter of between 0.014″ and about 0.018″.
5 . The method of claim 1 , wherein the taper of the distal tip is between 1.5 cm and 3 cm.
6 . The method of claim 1 , wherein the mechanical locking element is configured to be placed in a locked configuration to maintain a fixed position between the catheter and the catheter advancement element and in an unlocked configuration to allow for withdrawing the catheter advancement element from the lumen of the catheter.
7 . The method of claim 6 , wherein, when the distal end of the catheter reaches the target site, the mechanical locking element is placed in the unlocked configuration to withdraw the catheter advancement element from the lumen of the catheter.
8 . The method of claim 1 , wherein the cerebral vessel is an intracranial vessel and wherein the target site is an occlusion or a region near a face of an occlusion within the intracranial vessel.
9 . The method of claim 1 , further comprising a step of:
inserting a guide sheath into a blood vessel, the guide sheath comprising a lumen of the guide sheath extending between a proximal end region of the guide sheath and a distal end region of the guide sheath, the distal end region of the guide sheath having at least one opening in communication with the lumen of the guide sheath;
advancing the guide sheath toward the target site; and
inserting the catheter system while assembled through the guide sheath and advancing the catheter system while assembled so that at least a portion of the catheter extends out of the at least one opening of the guide sheath and the distal end of the catheter reaches the target site.
10 . The method of claim 9 , wherein advancing the guide sheath toward the target site comprises advancing the guide sheath to a common carotid artery.
11 . The method of claim 1 , further comprising:
inserting a guide sheath into a blood vessel, the guide sheath comprising a lumen of the guide sheath extending between a proximal end region of the guide sheath and a distal end region of the guide sheath, the distal end region of the guide sheath having at least one opening in communication with the lumen of the guide sheath;
assembling the guidewire through the catheter advancement element forming a coaxial system of devices including the catheter, the catheter advancement element, and the guidewire;
inserting the coaxial system of devices into the lumen of the guide sheath; and
advancing the coaxial system of devices through the guide sheath until at least a portion of the catheter extends out of the at least one opening of the guide sheath and the distal end of the catheter reaches the target site.
12 . The method of claim 1 , wherein the step of removing occlusive material further comprises:
inserting a retrievable stent device through the catheter;
capturing the occlusive material with the retrievable stent device; and
removing the occlusive material and the retrievable stent device from the target site.
13 . The method of claim 1 , further comprising using an aspiration pump to apply the negative pressure to the lumen of the catheter.
14 . The method of claim 1 , wherein the lumen of the catheter advancement element is the only lumen in the catheter advancement element, and wherein the distal opening is at a distal-most end of the catheter advancement element.
15 . The method of claim 1 , wherein, when the proximal end of the catheter advancement element is locked with the proximal end of the catheter by the mechanical locking element, a proximal end of the taper is positioned adjacent the distal end of the catheter.
16 . A method of performing a medical procedure at a treatment site in a cerebral vessel of a patient, the method comprising:
advancing an assembled system of devices distal to a petrous portion of an internal carotid artery, the assembled system of devices comprising:
an aspiration catheter having a flexible tubular portion defining a single catheter lumen; and
an inner member comprising a proximal portion having sufficient rigidity to push the assembled system of devices distally towards the treatment site and a distal end having a taper,
wherein, when assembled, the aspiration catheter and the inner member are locked into a fixed position relative to one another so that the inner member extends through the single catheter lumen and the distal end of the inner member extends distal to a distal end of the aspiration catheter and a proximal end of the inner member is locked with a proximal end of the aspiration catheter by a mechanical locking element;
reaching the treatment site within the cerebral vessel with the distal end of the aspiration catheter;
removing the inner member from the single catheter lumen; and
removing occlusive material while applying a negative pressure to the single catheter lumen to capture the occlusive material at, within, or through the distal end of the aspiration catheter.
17 . The method of claim 16 , further comprising unlocking the aspiration catheter and the inner member before removing the inner member from the single catheter lumen.
18 . The method of claim 16 , wherein the cerebral vessel is an intracranial vessel and wherein the treatment site is an occlusion or a region near a face of an occlusion within the intracranial vessel.
19 . The method of claim 16 , wherein the taper of the distal end of the inner member tapers distally from a first outer diameter to a second outer diameter that is smaller than the first outer diameter.
20 . The method of claim 19 , wherein the taper of the distal end of the inner member tapers over a length between 1.5 cm and 3 cm.
21 . The method of claim 19 , wherein the proximal portion extends proximally to outside the body of the patient.
22 . The method of claim 21 , wherein the proximal portion is a stiff wire or a hypotube.
23 . The method of claim 21 , wherein the first outer diameter is between about 0.003″ and about 0.010″ smaller than an inner diameter of the catheter lumen.
24 . The method of claim 23 , wherein the inner diameter of the catheter lumen is between about 0.040″ to about 0.088″.
25 . The method of claim 19 , wherein the proximal portion of the inner member has a third outer diameter that is smaller than the first outer diameter.
26 . The method of claim 16 , wherein the inner member further includes a single lumen.
27 . The method of claim 16 , further comprising a step of:
inserting a guide sheath into a blood vessel, the guide sheath comprising a lumen of the guide sheath extending between a proximal end region of the guide sheath and a distal end region of the guide sheath, the distal end region of the guide sheath having at least one opening in communication with the lumen of the guide sheath;
advancing the guide sheath toward the treatment site to a common carotid artery; and
inserting the assembled system of devices through the guide sheath and advancing the assembled system of devices so that at least a portion of the aspiration catheter extends out of the at least one opening of the guide sheath and the distal end of the aspiration catheter reaches the treatment site.
28 . The method of claim 16 , further comprising:
inserting a guide sheath into a blood vessel, the guide sheath comprising a lumen of the guide sheath extending between a proximal end region of the guide sheath and a distal end region of the guide sheath, the distal end region of the guide sheath having at least one opening in communication with the lumen of the guide sheath;
assembling a guidewire through a single lumen of the inner member forming a coaxial system of devices including the aspiration catheter, the inner member, and the guidewire;
inserting the coaxial system of devices into the lumen of the guide sheath; and
advancing the coaxial system of devices through the guide sheath until at least a portion of the aspiration catheter extends out of the at least one opening of the guide sheath and the distal end of the aspiration catheter reaches the treatment site.
29 . The method of claim 16 , wherein the step of removing occlusive material further comprises:
inserting a retrievable stent device through the aspiration catheter;
capturing the occlusive material with the retrievable stent device; and
removing the occlusive material and the retrievable stent device from the target site.
30 . The method of claim 16 , further comprising using an aspiration pump to apply the negative pressure through the aspiration catheter.
31 . The method of claim 16 , wherein, when the proximal end of the inner member is locked with the proximal end of the aspiration catheter by the mechanical locking element, a proximal end of the taper is positioned adjacent the distal end of the aspiration catheter.