Methods and systems for treatment of acute ischemic stroke

• US 10,226,563 B2
• Filed: 12/22/2009
• Issued: 03/12/2019
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Chou, Tony M., Hyde, Gregory M.
• Primary Examiner(s): Tanner, Jocelin
• Application Number:
  US12/645,179
• Publication Number:
  US 20100217276A1
• Time in Patent Office: 3,367 Days
• Field of Search: 606159, 606127, 606128, 606213, 606194, 606190-192, 606200, 604 22, 604 8, 604 9, 604131, 60410301, 604 612, 604187, 604509, 604500, 604151, 604 30- 36, 604 43, 60416701-16706, 604245-249, 604 9601
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 2007/0043 : intra-cavitary
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and devices are disclosed that enable safe, rapid and relatively short and straight access to the cerebral arteries for the introduction of interventional devices to treat acute ischemic stroke. In addition, the disclosed methods and devices provide means to securely close the access site to the cerebral arteries to avoid the potentially devastating consequences of a transcervical hematoma.

Claims

1. A method for accessing an intracranial artery pursuant to a procedure to treat acute ischemic stroke, comprising:

forming a penetration in a wall of a common carotid artery or internal carotid artery;

applying a closure device at a very beginning of the procedure at a site of the penetration and before placement of any structure through the penetration including an arterial access sheath, the closure device having sutures;

positioning an arterial access sheath having an occlusion element and an inner diameter that is between 7 Fr and 10 Fr through the penetration such that the occlusion element is positioned within the internal carotid artery;

occluding the internal carotid artery;

establishing retrograde blood flow through the internal carotid artery distal of the occluding element;

inserting a distal catheter having an aspiration lumen into the intracranial artery through the access sheath, the distal catheter further having a distal-most end that defines an opening into the aspiration lumen

treating a thrombotic blockage in the intracranial artery by positioning the distal-most end of the distal catheter so that the distal-most end is located immediately adjacent the thrombotic blockage in the intracranial artery;

aspirating blood and/or material from the thrombotic blockage in the intracranial artery into the opening at the distal-most end of the distal catheter such that the aspiration causes the blood and/or material from the thrombotic blockage to flow into the opening at the distal-most end of the distal catheter;

removing the arterial access sheath from the penetration; and

closing the access site with the sutures of the closure device.

2. A method as in claim 1, wherein establishing retrograde blood flow through the internal carotid artery comprises causing blood to flow into a lumen of the arterial access sheath and into a shunt connected to the access sheath.

3. A method as in claim 2, further comprising regulating the retrograde blood flow.

4. A method as in claim 2, further comprising controlling a state of the retrograde blood flow.

5. A method as in claim 2, further comprising monitoring the retrograde blood flow.

6. A method as in claim 1, wherein treating a thrombotic blockage further comprises inserting a treatment device through the arterial access sheath and positioning at least a portion of the treatment device in the intracranial artery for the purpose of at least removing or disrupting the thrombotic blockage.

7. A method as in claim 6, wherein removing the thrombotic blockage further comprises aspirating the thrombotic blockage or debris generated from the thrombotic blockage.

8. A method as in claim 1, wherein treating a thrombotic blockage further comprises establishing a lumen through the thrombotic blockage.

9. A method as in claim 8, wherein establishing a lumen comprises implanting a temporary or permanent stent in the thrombotic blockage.

10. A method as in claim 1, wherein treating a thrombotic blockage further comprises infusing a bolus of thrombolytic drug through the arterial access sheath to the thrombotic blockage in the intracranial artery.

11. A method as in claim 1, wherein the occlusion element is a balloon.