All-in-one arterial access and closure system (ACS)
The present invention features an all-in-one system for vascular access and closure. In particular, this invention features systems and methods for forming holes in blood vessels and rapidly closing these vessel holes using an all-in-one system. For example, an arterial access and closure port system is disclosed herein to provide fail-safe percutaneous entry and exit into any artery, particularly useful for high flow and high pressure arteries such as the carotid artery. The present invention is a single system that forms and closes vascular holes and can be used for percutaneous arterial access with interventional radiology, interventional cardiology, neuro-intervention, endovascular surgery, and endovascular neurosurgery.
1. A percutaneous blood vessel opening and closure system ( 199 ) comprising:
a) an inner tube ( 100 ) comprising a proximal end ( 102 ) and a distal end ( 104 ), wherein the distal end ( 104 ) is inserted through the skin, disposed on the surface of the vessel ( 200 ), and creates an opening or hole ( 150 ) in a vessel ( 200 ) and enters the vessel ( 200 ) to provide percutaneous access and entry to the vessel ( 200 );
b) an outer tube ( 110 ) that surrounds the inner tube ( 100 ), wherein the outer tube ( 110 ) is positioned relative to the inner tube ( 100 ) so that the distal end of the outer tube ( 114 ) is disposed at or near the vessel opening or hole ( 150 ) and does not enter the vessel ( 200 );
c) a flexible hinge ( 300 ) having a closure holder ( 302 ) and an arm ( 304 ), the arm having a distal end ( 312 ) and a proximal end ( 314 ) such that the closure holder is disposed at the proximal end ( 314 ), the distal end ( 312 ) is pivotally attached to an inner surface ( 116 ) of the outer tube distal end ( 114 ), the inner tube ( 100 ) when extended holds the flexible hinge ( 300 ) in a tension state, and the inner tube ( 100 ) when retracted causes the flexible hinge ( 300 ) to move to a memory state,
d) a detachable closure device ( 120 ) disposed at the flexible hinge ( 300 ) closure holder ( 302 ),
wherein the inner tube ( 100 ) is separable from the outer tube ( 110 ) to allow the flexible hinge ( 300 ) to move from a tension state to a memory state that allows the closure mechanism ( 120 ) to cover the vessel hole ( 150 ) and attach onto the outside of the vessel ( 210 ) in an enclosed position ( 124 ), wherein the closure device ( 120 ) is then detached from the flexible hinge closure holder ( 312 ) and the outer tube ( 110 ) is removed leaving the closure device ( 120 ) in an engaged position ( 126 ) to close the vessel opening ( 150 ),
wherein the system ( 99 ) integrates the opening of the vessel ( 200 ) as well as closing the vessel opening ( 150 ).
2. The system of claim 1 , wherein the flexible hinge ( 300 ) is a memory wire.
3. The system of claim 1 , wherein the vessel ( 200 ) is an artery or a vein.
4. The system of claim 1 , wherein the closure device ( 120 ) is detached from the flexible hinge ( 300 ) closure holder ( 312 ) by a mechanical release, or electrolytic or thermal disconnection.
5. The system of claim 1 , wherein the closure device ( 120 ) comprises a metal clip, a hemostatic foam, a suture, a biodegradable patch, an adhesive gel, and/or a device or a substance that effectively covers, seals, or closes the hole ( 150 ) in the vessel ( 200 ) in a fail-safe manner that prevents re-opening of the vessel hole ( 150 ).
6. The system of claim 1 further comprising a balloon inflation port ( 175 ) connected to a balloon inflation tube ( 176 ) integrated with the inner tube ( 100 ).