Pulmonary Embolism Therapeutic Devices and Associated Methods and Systems
Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Pulmonary Embolism or associated symptoms. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Pulmonary Embolism or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient's internal pulmonary veins. In some instances, stenoses or other flow limiting structures or lesions in the patient's affected veins are identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient's pulmonary veins are provided.
1 . A Pulmonary Embolism therapeutic device comprising:
a computing device configured to perform the steps of:
a. identifying venous outflow obstruction sites in a pulmonary vein; and either of the following steps b or c or both steps b and c performed in any order:
b. assessing the nature of a stenotic lesion associated with at least one of the venous outflow obstruction sites in the pulmonary vein;
c. determining the pressure gradient across the stenotic lesion as compared to the superior vena cava; and
d. applying a desired therapy to treat the stenotic lesion.
2 . The therapeutic device of claim 1 , further comprising an imaging system.
3 . The therapeutic device of claim 2 , wherein the imaging system is chosen from the group consisting of an intravascular ultrasound (IVUS) imaging system and an optical coherence tomography (OCT) system.
4 . The device of claim 1 , wherein the step of identifying venous outflow obstruction sites in pulmonary vessels includes sequentially accessing a pulmonary vein by selective venography at each of these sites to confirm or exclude a significant stenosis or flow disruption.
5 . The device of claim 1 , wherein the step of identifying venous outflow obstruction sites in pulmonary vessels includes both sequentially accessing a pulmonary vein by selective venography at each of these sites to confirm or exclude a significant stenosis or flow disruption and using ultrasonography to identify obstructed outflow sites.
6 . The device of claim 1 , wherein the step of identifying venous outflow obstruction sites in pulmonary vessels includes using transcutaneous echography applied to an accessible section of a pulmonary vein to identify venous outflow obstruction sites and to confirm or exclude a significant stenosis or flow disruption at those sites.
7 . The device of claim 1 , further comprising an angioplasty balloon, wherein the therapy is applying angioplasty to open or enlarge the troubling stenosis, and wherein the angioplasty balloon is a non-compliant balloon that will have a nominal inflated diameter of at least about 80% of the normal proximal non-stenosed vein.
8 . The device of claim 7 , wherein the angioplasty balloon is a one piece balloon.
9 . The device of claim 7 , wherein the angioplasty balloon is coated with or exuding a drug such as tissue plasminogen activator, urokinase, streptokinase, collagenace, hepranoids and any other fibrinolytic or direct anti-thrombin drug.
10 . The device of claim 7 , wherein the balloon is a cutting or scoring balloon.
11 . The device of claim 1 , further comprising an occlusive balloon, wherein the therapy is applying an occlusive balloon to the stenosis.
12 . The device of claim 11 , wherein the occlusive balloon comprises a catheter body with a distal end, an ultimate distal end, a proximal end, a central lumen, a balloon and a balloon lumen wherein the balloon is located a small distance from the ultimate distal end and the central lumen extends from the proximal end of the balloon catheter to the ultimate distal end and wherein the balloon catheter also has an imaging systems with at least a portion located at the distal end of the balloon catheter.
13 . The device of claim 12 , wherein the imaging transducer is selected from an IVUS or OCT imaging transducer that is part of an imaging system that allows the user to identify intravascular stenoses.
14 . The device of claim 1 , further comprising a cutting catheter, wherein the therapy is applying a cutting catheter to open or enlarge the troubling stenosis.
15 . The device of claim 14 , wherein the cutting catheter has a catheter body with a distal end, a proximal end, a central lumen through which a guide wire may be passed and an outer surface wherein the cutting catheter has an imaging transducer as part of an imaging system located at its distal end and wherein the cutting catheter includes cutting blades located on the outer surface near the distal end.
16 . The device of claim 1 , further comprising an ablation catheter, wherein the therapy is applying ablation chosen from the group consisting of laser, RF, cryoablation or other energy sources to open or enlarge the troubling stenosis.
17 . The device of claim 16 , wherein the ablation catheter includes a catheter body with a distal end, a proximal end, a central lumen through which a guide wire may be passed, an outer surface, and ablation system positioned adjacent the distal end.
18 . The device of claim 17 , wherein the ablation catheter further comprises an imaging transducer as part of an imaging system located at its distal end.
19 . The device of claim 1 , further comprising a delivery catheter, wherein the therapy is applying a therapeutic agent to the lesion through the delivery catheter to dissolve fibrin or thrombus present at or causing the lesion or otherwise treat the lesion, wherein the therapeutic agents that may be delivered to the lesion are chosen from the group consisting of tissue plasminogen activator, urokinase, streptokinase, collagenace, hepranoids and any other fibrinolytic or direct anti-thrombin drug.
20 . The device of claim 19 , wherein the delivery catheter further includes an imaging transducer as part of an imaging system located at its distal end.