METHODS AND SYSTEMS FOR TREATMENT OF ACUTE ISCHEMIC STROKE

• US 20110087147A1
• Filed: 12/13/2010
• Published: 04/14/2011
• Est. Priority Date: 12/23/2008
• Status: Abandoned Application

• Current Assignee: Neurocorp., Inc
• Original Assignee: Neurocorp., Inc
• Inventors: Garrison, Michi E., Hyde, Gregory M., Chou, Tony M.
• Application Number:
  US12/966,948
• Publication Number:
  US 20110087147A1
• Time in Patent Office: Days
• US Class Current: 604/8
• 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 a cerebral artery to treat acute ischemic stroke, comprising:

forming a transcervical puncture opening through a wall of a common carotid artery;

inserting through the puncture opening an arterial access sheath system configured to be inserted directly into the common carotid artery without previously inserting an introducer sheath through the opening, the arterial access sheath system comprising;

an arterial access sheath having an internal lumen extending between a proximal end region and a distal end region of the arterial access sheath;

a dilator inserted through the internal lumen and extending distal from the distal end region of the arterial access sheath; and

a first occlusion element coupled to a distal region of the arterial access sheath;

providing access to the cerebral artery via the internal lumen of the arterial access sheath; and

expanding the occlusion element of the arterial access sheath to occlude an artery selected from the group consisting of the common carotid artery and an internal carotid artery.

2. A method as in claim 1, wherein forming the transcervical puncture opening comprises making the puncture opening directly into the common carotid artery accessed through a transcervical surgical incision.

3. A method as in claim 1, wherein forming the transcervical puncture opening comprises performing a percutaneous puncture into the common carotid artery.

4. A method as in claim 1, wherein the dilator comprises an outer diameter that approaches an inner diameter of the distal end region of the arterial access sheath.

5. A method as in claim 1, further comprising:

reversing a direction of natural blood flow in the internal carotid artery or common carotid artery; and

shunting blood from the cerebral artery of the patient via the arterial access sheath.

6. A method as in claim 1, wherein the occlusion element is an inflatable balloon.

7. A method as in claim 1, further comprising:

inserting therapeutic device through the internal lumen of the arterial access sheath and into the cerebral artery; and

treating a thrombotic blockage in the cerebral artery.

8. A method as in claim 7, wherein the therapeutic device is a stent delivery catheter and treating the thrombotic blockage comprises deploying a stent using the stent delivery catheter.

9. A method as in claim 7, wherein the therapeutic device includes a device adapted to remove a thrombotic blockage.

10. A method as in claim 9, wherein the device adapted to remove a thrombotic blockage comprises at least one of a coil, a basket, a snare, or a grasper.

11. A method as in claim 7, wherein the therapeutic device includes a device adapted to disrupt a thrombotic blockage.

12. A method as in claim 11, wherein the device adapted to disrupt a thrombotic blockage comprises at least one of a mechanical, hydraulic, vortex, sonic, ultrasonic, or other energy source.

13. A method as in claim 7, wherein the therapeutic device includes a device adapted to aspirate the thrombotic blockage or debris generated from the thrombotic blockage.

14. A method as in claim 7, wherein the therapeutic device includes a device adapted to infuse thrombolytic agents into a thrombotic blockage.

15. A method as in claim 7, wherein the therapeutic device is a device adapted to establish a lumen through the thrombotic blockage.

16. A method as in claim 15, wherein the device adapted to establish a lumen through the thrombotic blockage comprises at least one of a balloon catheter, a temporary stent, or a permanent stent.

17. A method as in claim 1, wherein the distal end region of the sheath is tapered and wherein a distal end region of the dilator is tapered.

18. A system for treating acute ischemic stroke, comprising:

an arterial access sheath comprising an internal lumen extending between a proximal end region and a distal end region, wherein the arterial access sheath is adapted to provide access to a cerebral artery through a puncture opening in a wall of a common carotid artery;

a dilator adapted to be inserted through the internal lumen and extending distal to the distal end region of the arterial access sheath; and

an occlusion element coupled to the arterial access sheath at a distal region of the arterial access sheath, wherein the occlusion element is adapted to expand and occlude an artery selected from the group consisting of the common carotid artery and an internal carotid artery.

19. A system as in claim 18, wherein the arterial access sheath comprises a stepped or tapered configuration wherein the distal end region has a reduced diameter relative to the proximal end region of the arterial access sheath.

20. A system as in claim 18, wherein the arterial access sheath has a hoop strength sufficient to resist buckling of the arterial access sheath as the arterial access sheath is introduced into the common carotid artery.

21. A system as in claim 18, wherein the dilator comprises a tapered distal end and an outer diameter that approaches an inner diameter of the distal end region of the arterial access sheath.

22. A system as in claim 18, further comprising a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site.

23. A system as in claim 22, further comprising a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state, wherein the flow control assembly includes one or more components that interact with the blood flow through the shunt.

24. A system as in claim 18, wherein a distal tip of the arterial access sheath is configured to puncture the common carotid artery such that the arterial access sheath does not require a separate introducer device in order to be introduced into the common carotid artery.

25. A system as in claim 18, wherein the distal end region of the sheath is tapered.