Diagnostic vascular catheterization is a classification of invasive procedures in which a catheter and related are passed into a peripheral vein or artery, through the blood vessels, and into the heart or other vasculature. These procedures permit the study of the heart chambers and the arteries supplying the heart or other vasculatures of the body to diagnose illness or disease. Some examples of diagnostic vascular catheterization are, but not limited thereto, are coronary and peripheral vascular (e.g., renal artery, iliofemoral, aortic, cerebrovascular) angiography (or coronary arteriogaphy and angiography).
Therapeutic vascular catheterization (i.e., interventional catheterization) is a classification of invasive procedures in which a catheter and related are passed into a peripheral vein or artery, through the blood vessels, and into the heart or other vasculature. These procedures are intended primarily for the treatment of cardiac illness and disease as well as other vasculature illnesses and diseases. Often the goals of therapeutic vascular catheterization (interventional catheterization) have some similarities to diagnostic catheterization, except the goal is placement of the catheter to treat an underlying condition. Some examples of therapeutic cardiac catheterization are, but not limited thereto, percutaneous transluminal angioplasty (PTA) (alternatively, percutaneous transluminal coronary angioplasty (PTCA)), percutaneous coronary intervention (PCI), and percutaneous transluminal interventions (PTI). Interventional catherization to include, for example, all transluminal mechanisms of vascular lumen enlargement.
Some drawbacks that are associated with the various diagnostic and therapeutic vasculature catheterizations are, but not limited thereto, the unnecessary complications that can occur and restricted operations related to advancing or moving a guide wire. For example, but not limited thereto, when a guide is at the ostium of the coronary artery a 0.014 inch guide wire or any applicable sized guide wire is passed into the artery beyond the lesion or stenosis with the wire tip positioned distal to the lesion or stenosis. The physician then slides a dilatation device, e.g., stent or expandable component, over the guide wire (via a monorail catheter system or an over-the-wire catheter system) to the position of the lesion or stenosis. If the lesion or stenosis is too tight (i.e., smaller diameter than the undeployed stent) the stent cannot be delivered without some degree of leverage. The leverage can be achieved through the use of various guide manipulations and different types of guides. Despite adequate leverage (or extra support from the guide) by pushing the stent or dilation devices (such as expandable component, rotor bladder, stents, atherectomy devices, lasers, thrombectomy devices, etc.) the guide may be pushed backward thus passively pulling the guide wire with it. Further yet, sometimes when the guide is pushed backwards, due to the stored torque, potential energy, the guide can be dislodged more significantly over a greater distance thereby pulling the entire wire not only proximal to the lesion, but potentially completely out of the artery. While the leverage may be achieved by manipulating the guide this may lead to vessel trauma, cardiac trauma, etc. Further, the leveraging manipulation may also be unsuccessful when a device (such as a expandable component or stent) is transmitted on the guide wire that pushes the device against a lesion or stenosis, which in turn imposes a reactive force onto the guide catheter. The reactive force exerted on the guide causes the guide to move backwards with the wire also typically being pulled backwards with the guide, thereby passively pulling the guide wire across and proximally to the lesion or stenosis. If the guide wire moves backward across the lesion or stenosis then potentially the lesion may not be able to be re-crossed again thereby eliminating possible treatment of the lesion or stenosis. Also, when the physician tries to advance the device across a resistant lesion in a back and forth movement the guide wire will also go back and forth in a to and fro type motion and each time the wire tip goes forward it may injure the vessel. It should be appreciated that the to and fro motion of the guide wire leads to the wire tip potentially causing vessel injury with each forward advancement because it can catch onto a plaque, for example, and cause dissection leading to vessel occlusion, plaque disruption leading to thrombosis and vessel occlusion and vessel perforation all of which have a high risk of leading to death, tissue infarction, stroke, hemorrhage and circulatory collapse as well as emergency surgery. It should be appreciated that even if the lesion or stenosis has been pre-dilated the aforementioned risks, such as dissection, are more likely to occur because when re-crossing the lesion or stenosis the guide wire tip may enter a dissection plane.
One should appreciate that in the event that a guide wire is successfully transmitted across a lesion but is then undesirably/unintentionally withdrawn then the guide wire will need to be repositioned forward across the lesion. The second re-crossing (or any subsequent re-crossing thereafter) of the lesion may be significantly more difficult and/or risky compared to the first (or a previous) forward placement.
Further, if the lesion has been pre-dilated with a expandable component or pre-treated with a rotor bladder, atherectomy devices, lasers, thrombectomy devices, etc., dissection planes commonly occur. Therefore, when the physician tries to re-cross the lesion with a 0.014 inch diameter guide wire (or any applicable size guide wire) then the guide wire can easily track between layers of the artery causing a dissection or propagating a previous dissection and thus occluding the artery, causing a myocardial infarction and all of its sequelae. A pre-dilated lesion typically provides a dissection inherently.
There is therefore a need in the art for a more effective and safer method of wire positioning and prevention of wire tip vessel trauma while practicing diagnostic and therapeutic vasculature catheterization. The various aspects of the embodiments of the present invention overcome and/or mitigate the aforementioned problems.