Method for Transfemoral Percutaneous Establishment of Retrograde Blood Flow

Abstract

A method for transfemoral percutaneous establishment of retrograde blood flow. More particularly, a transfemoral percutaneous approach to an interventional procedure on the neurovasculature performed through a transfemoral access while retrograde blood flow is established from the internal vessel artery to a second vessel.

Claims

1. A method for establishing retrograde blood flow using a transfemoral percutaneous procedure, comprising the steps of: First, obtaining endovascular access of a common target vessel via percutaneous procedural technique, optionally transfemoral, said access being located at distance of about 2 to 3 inches below a bifurcation location where the patient's common target vessel bifurcates into an internal target vessel and an external target vessel; Second, positioning a vessel-access sheath through the transfemoral percutaneous procedural incision into the common target vessel, wherein the vessel-access sheath includes an expandable element at some point along its distal 6 inches; Third, expanding said expandable element so that said expandable element blocks blood flow through the common target vessel past the sheath, and establish a reverse blood flow through the internal target vessel, and into said sheath, wherein blood flows into a shunt of said sheath while the common target vessel remains blocked; Fourth, actively assisting blood flow from the common target vessel into said sheath and into said shunt.

2. The method of claim 1, further including in said First step, obtaining endovascular access of a common target vessel via transfemoral percutaneous procedural technique, said access being located at distance of about 2 to 3 inches below a bifurcation location where the patient's common target vessel bifurcates into an internal target vessel and an external target vessel.

3. The method of claim 1, further including in said Fourth step filtering any debris from the blood within said shunt; flowing the blood from said shunt to a return location.

Description

DETAILED DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1 depicts the vasculature in a patient's neck, including the common target vessel CTV, the internal target vessel ITV, and the external target vessel ETV; labeling ITV as 1, ETV as 2, and CTV as 3.

[0034] FIG. 2 depicts the hardware's relative positions during the implementation of the present invention's method for transfemoral percutaneous establishment of retrograde blood flow; labeling ITV as 1, RGC as 10, and Silk Road Enroute Neuroprotection circuit as 20, optical sheath as 30, additional sheath in collateral jugular vein for blood return as 40, IVC as 50, filter tip BGC as 60, iliac vein thrombus as 70, rotating, irrigating macerator as 80

DETAILED DESCRIPTION OF THE INVENTION

[0035] The present invention is a method for transfemoral percutaneous establishment of retrograde blood flow during a medical procedure. While all embodiments of said method are designed to implement a single idea (transfemoral percutaneous establishment blood flow), the embodiment may contain a variety of step which depend upon the medical procedure for which they are used.

[0036] Angioplasty and/or stenting from proximal approach, with upstream arterial access: Nonlimiting example: Carotid stenosis. Via standard percutaneous approaches (preferentially but optionally transfemoral) a balloon guide catheter (BGC) such as the Stryker Flowgate(https://www.strykerneurovascular.com/products/ais/flowgate-balloon-guide-catheter) or Medtronic Cello can be introduced into the common carotid artery under fluoroscopic guidance, using standard interventional/angiographic techniques. In select difficult arch anatomy cases, various difficult angle access catheters previously described by Walzman (patents pending) can optionally be used to help position the BCG 10. The balloon guide can then be used instead of the Silk Road custom short sheath and clamp/tourniquet described for use in their original procedure. Inflating the balloon on the BCG 10 has the same flow arrest properties as the clamp/tourniquet in standard open technique, and the Silk Road Enroute Neuroprotection circuit 20 or a similar filter pump system can be attached to the proximal end of the BCG 10 (instead of the standard practice of attaching the filter pump system to the proximal end of the custom short sheath). The balloon guide catheter sheath is attached to the filter pump system, and the other side of the pump is attached to another sheath that was inserted in the femoral vein. After both catheters/sheaths are in place and the circuit is attached, the balloon on the BCG 10 is inflated to arrest normal antegrade flow in the carotid artery. The pump is then turned on, which reverses flow in the carotid artery. The blood flows out into the circuit, through the filter, and back into the patient through the femoral vein sheath, for a net of minimal blood loss. Under x-ray guidance a wire is then passed through the balloon guide catheter, typically but not exclusively via the transfemoral approach, across the plaque further up in the carotid artery. Then an angioplasty balloon is advanced over the wire and dilated, to widen the narrowing in the artery at the plaque. The angioplasty balloon is deflated and removed over the wire, which is left in place. A stent is then advanced over the wire and deployed across the narrowing. After removing the stent delivery system additional angiographic images are done. Additional balloon angioplasties can then optionally be done as needed. Then the wire is removed. At the end of the procedure the balloon is deflated and the pump is turned off. The BCG 10 is then removed. Femoral arterial hemostasis can be achieved with manual compression or with a standard closure device (such as Angioseal). The venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (such as Mynx, off-label). Alternatively, for smaller vessels where less blood loss may be anticipated, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood.

[0037] Angioplasty and/or stenting with Downstream arterial access: nonlimiting exampleaxillary artery stenosispercutaneous transradial or transbrachial access can be obtained in standard fashion, and utilizing standard endovascular techniques a BCG 10 can be advanced into the axillary artery distal to the stenosis. The balloon guide and Enroute Neuroprotection 20 filter pump can then be used instead of typical filter wire._The Silk Road Enroute Neuroprotection 20 circuit or a similar filter pump system can be attached to the proximal end of the BCG 10. The balloon guide catheter sheath is attached to the filter pump system, and the other side of the pump is attached to another sheath 40 that was inserted in the femoral vein (or any large enough vessel). After both catheters/sheaths are in place and the circuit is attached, the balloon on the BCG 10 is inflated to arrest normal antegrade flow in the artery. The pump (Enroute Neuroprotection System 20) is then turned on, which reroutes flow from the artery. The blood flows out into the circuit, through the filter, and back into the patient through the femoral vein sheath, for a net of minimal blood loss. Under x-ray guidance a wire is then passed through the balloon guide catheter across the plaque further proximally in the artery. Then an angioplasty balloon is advanced over the wire and dilated, to widen the narrowing in the artery at the plaque. The angioplasty balloon is deflated and removed over the wire, which is left in place. A stent is then advanced over the wire and deployed across the narrowing. After removing the stent delivery system additional angiographic images are done. Additional balloon angioplasties can then optionally be done as needed. Then the wire is removed. At the end of the procedure the balloon is deflated and the pump is turned off. The BCG 10 is then removed. Arterial hemostasis can be achieved manually or with a standard closure device (off-label). The venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (off-label).

[0038] Alternatively, for smaller vessels where less blood loss may be anticipated, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood.)

[0039] Arterial thrombectomy from proximal to clotupstream approachnon-limiting examplemca embolic stroke in distal Right M1 segment: percutaneous transfemoral or other access can be obtained in standard fashion, and utilizing standard endovascular techniques a large long sheath/catheter is placed into the right internal carotid artery. Through that sheath/catheter an appropriately sized BCG 10 can be advanced over a wire (or over a smaller catheter and a wire) into distal ICA or preferentially into the proximal mca, where a sump of blood from unaffected brain territory can be limited, and the potential for emboli to other vascular territories eliminated. A new, more flexible BCG 10 will need to be made for many applications, especially intracranial. The balloon guide catheter and Enroute Neuroprotection 20 filter pump can then be used to reverse flow in the mca. First the balloon is inflated to arrest flow. Then an irrigating and macerating element, such as that described by Walzman elsewhere, or Angiojet, or similar, would be advanced through the thrombus. (Alternatively, a small irrigation catheter alone can be used, without maceration). (Alternatively the simultaneous active irrigation and aspiration can be supplemented with the use of a stent-triever or similar clot retrieval device.) The balloon guide catheter/sheath is attached to the filter pump system, and the other side of the pump is attached to another sheath that was inserted in the femoral vein (or any large enough vessel). After both sheaths are in place and the circuit (Enroute Neuroprotection System 20) is attached. the pump is turned on, which reroutes flow from the artery. This is combined with simultaneous irrigation into and distal to the thrombus, which reverses flow in the mca. Additional simultaneous rotational maceration or jet maceration or similar is also added as needed to break the thrombus into smaller pieces and release its adhesion to the arterial walls. The blood, clots, and irrigant flows out into the circuit, through the filter, and back into the patient through the femoral vein sheath, for a net of minimal blood loss. Injections of contrast through the aspiration catheter or BCG 10 (after adequate back-bleeding) can confirm effective removal of the embolus/thrombus. Then the pump is turned off and the balloon is deflated,and antegrade flow in the mca is restored. Additional angiography can confirm the efficacy of the thrombectomy. The BCG 10 is then removed. The large long carotid sheath/catheter is removed, and arterial hemostasis can be achieved manually or with a standard closure device (off-label). The venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (off-label).

[0040] Alternatively, for smaller vessels such as the mca, where acceptable amounts of blood loss may be anticipated, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood.

[0041] Arterial Thrombectomy from distal to clot,downstream approachas above in C, but because the BCG 10 is introduced from downstream to the thrombus/embolus, the flow is never reversed.

[0042] Nonlimiting exampleipsilateral percutaneous transfemoral access for an ipsilateral iliac artery thrombus 70: Percutaneous transfemoral access can be obtained in standard fashion, and a BCG 10 can be advanced into the proximal femoral artery or distal iliac artery, distal to the thrombus. The balloon on the BCG 10 is inflated to arrest normal antegrade flow in the artery. An irrigating and macerating element, such as that described by Walzman elsewhere, or Angiojet, or similar, would first be advanced through the thrombus. (Alternatively, a small irrigation catheter alone can be used, without maceration). (Alternatively, the flow circuit created by the vessel occlusion with the balloon, and the simultaneous aspiration and optional active irrigation, can be supplemented with the use of a stent-triever or similar clot retrieval device.) The balloon guide catheter sheath is attached to the filter pump system, and the other side of the pump is attached to another sheath that was inserted in the femoral vein (or any large enough vessel). After both catheters/sheaths are in place and the circuit is attached the pump is then turned on, which reroutes flow from the artery. (Note, in all examples the circuit can alternatively optionally be turned on before crossing the pathological lesion as well). This is combined with simultaneous rotational maceration or jet maceration or similar across the thrombus to break the thrombus into smaller pieces and release its adhesion to the arterial walls. The blood flows out into the circuit (Enroute Neuroprotection System 20), through the filter, and back into the patient through the femoral vein sheath, for a net of minimal blood loss. All thrombi, emboli, and other debris are diverted into the pump circuit and filter, which prevents distal embolic showering and its attendant risks of ischemic injury to tissue. Injections of contrast through the aspiration catheter or other devices can confirm effective removal of the embolus/thrombus. Then the balloon is deflated and the pump is turned off, and antegrade flow in the artery is restored. Additional angiography can confirm the efficacy of the thrombectomy. The BCG 10 is then removed. The arterial sheath hemostasis can be achieved manually or with a standard closure device (off-label). The venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (off-label).

[0043] Alternatively, for procedures where acceptable amounts of blood loss may be anticipated, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood.

[0044] Alternatively, for procedures where acceptable amounts of blood loss may be anticipated, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood. Venous thrombectomy from downstream only: Nonlimiting example (now referring to FIG. 2 wherein): Iliac clot (or iliofemoral) 70 extending to the junction of the iliac vein with the Inferior Vena cava, with Pertcutaneous Approach from Internal Jugular Vein: Using Standard techniques a large BCG 10 can be advanced into the proximal inferior vena cava (IVC) 50. The balloon guide catheter sheath is attached to the filter pump system (Enroute Neuroprotection System 20), and the other side of the pump is attached to another sheath that was inserted in additional venous sheath in a vein that does not flow downstream to the BGC 10/Filter-tip catheter (iecontralateral internal jugular vein). After both catheters/sheaths are in place and the circuit is attached, the balloon on the BCG 10 is inflated to arrest normal antegrade flow in the vessel, and/or the filter is deployed (if not yet deployed). The pump is then turned on, which reroutes flow from the vein. Additional simultaneous rotational maceration or jet maceration or similar is also added as needed to break the thrombus into smaller pieces and release its adhesion to the vein's walls. This is combined with simultaneous optional irrigation into and proximal to the thrombus. The blood flows out into the circuit (Enroute Neuroprotection System 20), through the filter, and back into the patient through an additional venous sheath, for a net of minimal blood loss. A macerating element, with optional additional irrigation, such as that described by Walzman elsewhere, or Angiojet, or Argon Cleaner XT or similar is through the thrombus. With flow reversed by aspiration, simultaneous maceration and/or irrigation are added to break up and free up the clot, and promote flow into the BCG 10 and the Enroute Neuroprotection System 20. Emboli to the lungs and/or heart are avoided. Injections of contrast through the BCG 10 or other devices can confirm effective removal of the embolus/thrombus. Then the balloon is deflated and the pump is turned off, and antegrade flow in the vein is restored. Additional angiography can confirm the efficacy of the thrombectomy. The BCG 10 is then removed. Venous hemostasis can be achieved manually or with a standard closure device (off-label). The second venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (off-label).

[0045] Alternatively, if using the semipermeable filter tip aspiration catheter, where acceptable amounts of blood loss may be anticipated because only intermittent aspiration can sometimes be used, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood.

[0046] Non-limiting example 2: Dialysis Arm AV fistula clot, with Pertcutaneous Approach from Femoral Vein: Using Standard techniques an appropriately sized BCG 10 can be advanced over a wire (or over a smaller catheter and a wire) into axillary vein, brachial vein, or subclavian vein (downstream from the clot). The BGC 10 may optionally have a filter tip 60. For this application the filter can be semipermeable or impermeable. Alternatively, a filter tip aspiration catheter previously described by Walzman (patent pending) alone can be used (without a balloon, since the filter will prevent downstream emboli. Furthermore, since in this example the positioning is downstream, so there is no need for induced flow-reversal). The balloon guide catheter sheath is attached to the filter pump system (Enroute Neuroprotection System 20), and the other side of the pump is attached to another sheath that was inserted in additional venous sheath in a vein that does not flow downstream to the BGC/Filter-tip catheter (ieinternal jugular vein, or contralateral femoral vein). After both catheters/sheaths are in place and the circuit is attached, the balloon on the BCG 10 is inflated to arrest normal antegrade flow in the vessel, and/or the filter is deployed (if not yet deployed). A macerating element, with optional additional irrigation, such as that described by Walzman elsewhere, or Angiojet, or Argon Cleaner, or angioplasty balloon, or similar, would first be advanced through the thrombus. The pump is then turned on, which reroutes flow from the vein. Additional simultaneous rotational maceration or jet maceration or angioplasty or similar is performed as needed to break the thrombus into smaller pieces and release its adhesion to the AV fistula vessel walls. This is combined with simultaneous optional irrigation into and proximal to the thrombus. The blood flows out into the circuit (Enroute Neuroprotection System 20), through the filter, and back into the patient through an additional venous sheath, for a net of minimal blood loss. Emboli to the lungs and/or heart are avoided. Injections of contrast through the aspiration catheter or the BCG 10 or other devicesvcan confirm effective removal of the embolus/thrombus. Then the balloon is deflated and the pump is turned off, and antegrade flow in the vein is restored. Additional angiography can confirm the efficacy of the thrombectomy. The BCG 10 is then removed. Venous hemostasis can be achieved manually or with a standard closure device (off-label). The second venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (off-label). {Alternatively, if using the semipermeable filter tip aspiration catheter, and/or where acceptable amounts of blood loss may be anticipated, sometimes because only intermittent aspiration can sometimes be used, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood. Venous Thrombectomy from upstream only:

[0047] Non-limiting example: Iliac clot, with Pertcutaneous Approach from ipsilateral Femoral Vein: Using Standard techniques an appropriately sized BCG 10 can be advanced into the femoral vein or proximal iliac vein (upstream from the clot). The balloon guide catheter sheath is attached to the filter pump system (Enroute Neuroprotection System 20), and the other side of the pump is attached to another sheath that was inserted in additional venous sheath in another vein that does not flow downstream to the BCG 10/Filter-tip 60 catheter (ieinternal jugular vein, or contralateral femoral vein). After both catheters/sheaths are in place and the circuit is attached, the balloon on the BCG 10 is inflated to arrest normal ante-grade flow in the vessel. The pump is then turned on, which reroutes flow from the vessel. A macerating element, with optional additional irrigation, such as that described by Walzman elsewhere, or Angiojet, or Argon Cleaner, or angioplasty balloon, or similar, would be advanced through the thrombus. Then additional simultaneous rotational maceration or jet maceration or angioplasty or similar is performed as needed to break the thrombus into smaller pieces and release its adhesion to the AV fistula vessel walls. This is combined with simultaneous optional irrigation into and proximal and distal to the thrombus. The blood flows out into the circuit (Enroute Neuroprotection System 20), through the filter, and back into the patient through an additional venous sheath, for a net of minimal blood loss. Emboli to the lungs and/or heart are avoided. Injections of contrast through the BCG 10 or other devices can confirm effective removal of the embolus/thrombus. Then the balloon is deflated and the pump is turned off, and ante-grade flow in the vein is restored. Additional angiography can confirm the efficacy of the thrombectomy. The BCG 10 is then removed. Venous hemostasis can be achieved manually or with a standard closure device (off-label). The second venous sheath can also be removed, and hemostasis can be achieved with manual compression or with a standard closure device (off-label). {Alternatively, where acceptable amounts of blood loss may be anticipated, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System 20, without a venous sheath and return of removed blood.

[0048] Venous thrombectomy with combined approachsimilar steps to other venous thrombectomy methods described above, optionally using Enroute Neuroprotection System 20 to aspirate, filter and return the blood, but where the macerating element or similar is introduced from the opposite approach. As a non-limiting examplefor a femoral vein thrombusthe filter-tip aspiration catheter (or filter tip BGC 60) can be introduced through either IJV into the mid-IVC 50, where the filter is deployed. An additional sheath/catheter 40 is placed in the other IJV for blood return via the Enroute Neuroprotection System 20. The circuit is hooked up. A second catheter/sheath is placed via the popliteal vein ipsilateral to the clot, and through that the irrigating macerator, BS Angiojet, Argon Cleaner, or similar is advanced into and across the clot. Maceration is performed with continuous or intermittent aspiration through the Enroute Neuroprotection System. Intermittent contrast injections can be performed to monitor thrombus removal, with or with put supplemental external ultrasound or IVUS (These can optionally be used in all examples as well). Once adequate clot removal is achieved, the pump is turned off Any balloons are deflated and all devices are removed, with appropriate hemostasis. the semipermeable filter tip aspiration catheter, and/or where acceptable amounts of blood loss may be anticipated, sometimes because only intermittent aspiration can sometimes be used, a blood removal pump such as the Penumbra vacuum system can be optionally used instead of the Enroute Neuroprotection System, without a venous sheath and return of removed blood.

[0049] In sum, the present invention also teaches a method using of the Enroute Neuroprotection System; also novel uses of Balloon Guide catheters and B.S. Angiojet, Argon Cleaner, and similar devices (using these protective modalities is the novelty); also novel uses of Penumbra aspiration and similar, as well as

[0050] Although the invention has been described in detail in the foregoing embodiments for the purpose of illustration, it is to be understood that such detail is solely for that purpose, and that variations can be made therein by those skilled in the art without departing from the spirit and scope of the invention, except as it may be described by the following claims.