TOOLS AND METHODS FOR DIRECTLY ACCESSING THE CAROTID ARTERY

1 . An introducer and flow redirection system for use in carotid angioplasty procedures, the system comprising:

a sheath assembly including;

a stabilizer,

a stabilizer foot coupled to the stabilizer and including a stabilizer eyelet configured to secure a suture,

a gripping mechanism coupled to the stabilizer remote from the stabilizer foot and including a valve eyelet configured to secure the suture,

an introducer sheath extending through the gripping mechanism, the stabilizer, and the stabilizer foot, and

an entry luer coupled to the introducer sheath;

wherein the gripping mechanism selectively locks the introducer sheath in place relative to the stabilizer;

a hemostatic valve including a hemostatic valve entry port coupled to the entry luer, a bypass port, and an access port;

a stopcock including a stopcock entry port, a collection port, and a stopcock valve providing selective communication between the stopcock entry port and the collection port; and

a collection bag connected to the collection port.

2 . The introducer and flow redirection system of claim 1 , wherein the stabilizer includes an elastomeric outer layer, a stainless steel coil, and a Polytetrafluoroethylene (PTFE) liner sized to receive the introducer sheath.

3 . The introducer and flow redirection system of claim 1 , wherein the stabilizer foot comprises silicone.

4 . The introducer and flow redirection system of claim 1 , wherein the introducer sheath includes printed indicators and a radiopaque marker.

5 . The introducer and flow redirection system of claim 1 , wherein the gripping mechanism is a Tuohy Borst valve.

6 . The introducer and flow redirection system of claim 1 , further comprising a flow control handle arranged between the collection port of the stopcock and the collection bag.

7 . The introducer and flow redirection system of claim 6 , wherein the flow control handle includes a flow control switch, a flow restrictor, and a flow visualization chamber.

8 . The introducer and flow redirection system of claim 7 , wherein the flow control switch defines a low flow position configured for use when an artery is unclamped and a high flow position configured for use when the artery is clamped.

9 . The introducer and flow redirection system of claim 1 , wherein the collection bag is non-aspirated.

10 . The introducer and flow redirection system of claim 1 , wherein the collection bag is configured to be positioned vertically below the introducer sheath to provide gravity flow from the collection port of the stopcock to the collection bag.

11 . The introducer and flow redirection system of claim 1 , further comprising an angioplasty device disposed within the introducer sheath.

12 . The introducer and flow redirection system of claim 11 , wherein the angioplasty device includes a self-collapsing filter and a self-expanding stent.

13 . The introducer and flow redirection system of claim 12 , wherein the self-collapsing filter comprises a filter membrane, the filter membrane having a pore size of between forty microns and one hundred microns.

14 . The introducer and flow redirection system of claim 1 , wherein the hemostatic valve is directly coupled to the entry luer, and the stopcock is directly coupled to the hemostatic valve.

15 . The introducer and flow redirection system of claim 1 , configured for introduction to a patient above a clavicle.

16 . A method of performing a carotid angioplasty, comprising:

inserting an introducer sheath through a stabilizer including a stabilizer foot and a gripping mechanism;

inserting the introducer sheath into a first incision made in skin above a patient's clavicle and into a second incision made in a patient's carotid artery;

positioning the stabilizer foot adjacent the first incision and the second incision;

engaging the skin adjacent the first incision with a suture;

securing the suture to an eyelet of the stabilizer foot; and

providing a reverse flow from the introducer sheath to a collection bag via a hemostatic valve and a stopcock.

17 . The method of claim 16 , further comprising locking the introducer sheath in position relative to the stabilizer with the gripping mechanism.

18 . The method of claim 16 , further comprising adjusting a flow control switch arrangement between the collection bag and the stopcock from a low flow position to a high flow position during reverse flow.

19 . The method of claim 16 , further comprising introducing an angioplasty device including a self-collapsing filter and a self-expanding stent through the introducer sheath and expanding the self-collapsing filter at a location distal to a vascular lesion.

20 . A carotid angioplasty kit, comprising:

a stabilizer including a stabilizer foot, a suture eyelet configured to secure a suture and maintain the stabilizer foot in position relative to an incision, and a gripping mechanism;

an introducer sheath sized to be engaged by the gripping mechanism and be received through the stabilizer;

a dilator sized to be received in the introducer sheath;

a hemostatic valve configured to be coupled to the introducer sheath;

a collection bag in fluid communication with the hemostatic valve; and

an angioplasty device sized to be disposed within the introducer sheath.

21 . The carotid angioplasty kit of claim 20 , further comprising a flow control handle configured to control reverse flow to the collection bag.