Methods and systems for treatment of acute ischemic stroke

• US 10,327,790 B2
• Filed: 08/03/2012
• Issued: 06/25/2019
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Garrison, Michi E., Chou, Tony M., Hyde, Gregory M., Schaer, Alan K.
• Primary Examiner(s): Mensh, Andrew J
• Application Number:
  US13/566,451
• Publication Number:
  US 20130035628A1
• Time in Patent Office: 2,517 Days
• Field of Search: 604 8, 604 9, 604508, 604509, 604523, 606159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• 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 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/82 Membrane pumps, e.g. bulbs
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 60/43 using vacuum at the blood pump, e.g. to accelerate filling

Abstract

Described are methods and systems for transcervical access of the cerebral arterial vasculature and treatment of cerebral occlusions, including ischemic stroke. The methods and devices may include methods and devices which may provide aspiration and passive flow reversal, those which protect the cerebral penumbra during the procedure to minimize injury to brain, as well as distal catheters and devices to remove an occlusion. The methods and devices that provide passive flow reversal may also offer to the user a degree of flow control. Devices and methods which provide a way to securely close the access site in the carotid artery to avoid the potentially devastating consequences of a transcervical hematoma are also described.

Claims

1. A system of devices for treating an occlusion in a cerebral artery of a patient, comprising:

a transcervical access sheath adapted to be introduced into a common carotid artery via an opening directly in the artery, the opening being positioned above the patient'"'"'s clavicle and below a bifurcation location where the patient'"'"'s common carotid artery bifurcates into an internal carotid artery and external carotid artery, wherein the transcervical access sheath has an internal lumen and a portion that splits into a first, proximal, expandable region and a second proximal, expandable region in parallel to the first proximal, expandable region;

a distal catheter sized and shaped to be inserted axially through the internal lumen of the transcervical access sheath such that the distal catheter can be inserted into a cerebral artery via the transcervical access sheath, wherein the distal catheter has an internal lumen defined by an inner diameter, and wherein the distal catheter is longer than the access sheath and wherein the distal catheter has a length sufficient for a distal end of the distal catheter to reach a cerebral artery when a proximal region of the distal catheter is located in the common carotid artery, and wherein a distal region of the distal catheter is more flexible than a proximal region of the distal catheter, and wherein the distal catheter has a total length such that a proximal-most region of the distal catheter can be positioned in the common carotid artery while the distal region of the distal catheter is simultaneously positioned in the cerebral artery;

an elongated inner member sized and shaped to be inserted axially through the lumen of the transcervical access sheath, wherein the inner member has an internal lumen;

a guidewire configured to be inserted into the cerebral artery via internal lumen of the inner member;

wherein the inner member has an outer diameter configured to form a smooth transition between the inner diameter of the distal catheter and the outer diameter of the guidewire; and

a first aspiration pump device fluidly connected to the internal lumen of the access sheath, the pump device including a first outer housing that encloses a first chamber that contains the first proximal, expandable region of the access sheath;

a second aspiration pump device fluidly connected to the internal lumen of the access sheath, the pump device including a second outer housing that encloses a second chamber that contains the second proximal, expandable region of the access sheath, wherein the first aspiration pump device and the second aspiration pump device alternate between expanded and retracted states such that the first aspiration pump device is in in an expanded state while the second aspiration pump device is in in a retracted state such that the first aspiration pump device and the second aspiration pump device collectively drive fluid through the internal lumen of the access sheath;

a vacuum source coupled to the chamber of the aspiration pump device, wherein the vacuum source activates to create a reduced pressure within the chamber relative to the pressure within the internal lumen of the access sheath to cause the proximal, expandable region of the access sheath to expand to an increased volume within the chamber and thereby pull blood into the proximal, expandable region of the access sheath;

a first check valve at an entranceway to the chamber of the aspiration pump device, wherein the first check valve is a one-way check valve that opens to permit fluid to flow only in a direction into the chamber when the proximal, expandable region of the access sheath expands to an increased volume within the chamber; and

a second check valve at an exit way out of the chamber of the aspiration pump device, wherein the second check valve is a one-way check valve that opens to permit fluid to flow only in a direction out of the chamber.

2. The system of claim 1, wherein a distal, tapered region of the inner member has an outer diameter that tapers in size toward the outer diameter of the guidewire.

3. The system of claim 1, wherein the inner member has a first, tapered region having an outer diameter that tapers toward the outer diameter of the guidewire, and a second distal-most region having an outer diameter that is constant, and wherein the guidewire protrudes out of the distal-most region.

4. The system of claim 1, further comprising a flow line connected to the access sheath, wherein the flow line provides a pathway for blood to flow from the access sheath to a return site.

5. The system of claim 4, further comprising a flow controller coupled to the transcervical access sheath and adapted to regulate blood flow through the transcervical access sheath.

6. A system of devices as in claim 1, further comprising a radio-opaque marker at a distal end of the distal catheter.

7. A system of devices as in claim 1, wherein the distal region of the distal catheter is 3 cm to 6 cm in length.

8. A system of devices as in claim 1, wherein the distal catheter has a plurality of sections, and wherein the sections increase in stiffness moving in a proximal direction along the distal catheter.

9. A system of devices as in claim 1, wherein the distal catheter has a length longer than a length of the transcervical access sheath such that a proximal end of the distal catheter can protrude from a proximal end of the transcervical access sheath and a distal end of the distal catheter can protrude from the distal opening of the transcervical access sheath when the distal catheter is positioned inside the transcervical access sheath.

10. A system of devices as in claim 9, wherein the distal end of the distal catheter can protrude from the distal opening of the transcervical access sheath by 15-25 cm.

11. A system of devices as in claim 1, wherein the distal catheter has a working length of 40 to 80 cm.

12. A system of devices as in claim 11, wherein the transcervical access sheath has a working length of 10 to 15 cm.

13. A system of devices as in claim 11, wherein the transcervical access sheath has a working length of 15 to 25 cm.

14. A system of devices as in claim 1, wherein the distal catheter is also connected to the vacuum source.