Deep Vein Thrombosis Diagnostic Devices and Associated Methods and Systems
Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Deep Vein Thrombosis or associated symptoms. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Deep Vein Thrombosis or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient's internal peripheral 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 peripheral veins are provided.
1 . A Deep Vein Thrombosis diagnostic device comprising:
a computing device configured to perform the steps of:
identifying venous outflow obstruction sites in a peripheral vein;
assessing the nature of a stenotic lesion associated with at least one of the identified venous outflow obstruction sites in the peripheral vein; and
determining a pressure gradient across the stenosis as compared to the superior vena cava.
2 . The device of claim 1 wherein the computing device includes an imaging system selected from the group consisting of an intravascular ultrasound (IVUS) imaging system and an optical coherence tomography (OCT) system.
3 . The device of claim 1 wherein the step of identifying venous outflow obstruction sites in a peripheral vein includes sequentially accessing peripheral veins by selective venography at each of these sites to confirm or exclude a significant stenosis or flow disruption.
4 . The device of claim 1 wherein the step of identifying venous outflow obstruction sites includes using ultrasonography to identify obstructed outflow sites.
5 . The device of claim 4 wherein the step of identifying venous outflow obstruction sites includes using ultrasonography includes using duplex ultrasonography.
6 . The device of claim 1 wherein the step of identifying venous outflow obstruction sites in a peripheral vein includes both sequentially accessing peripheral veins 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.
7 . The device of claim 1 wherein the step of identifying venous outflow obstruction sites in a peripheral vein includes using transcutaneous echography applied to an accessible section of a peripheral vein to identify venous outflow obstruction sites and to confirm or exclude a significant stenosis or flow disruption at those sites.
8 . The device of claim 1 wherein the step of identifying venous outflow obstruction sites includes the steps of:
a) applying radionuclides that bind to proteins specific to fibrin, such as radionuclides bound to insulin-like growth factor (IGF) binding proteins (IGFBPs), preferably near where an obstruction is believed to be located;
b) detecting radiation emitted by the radionuclides that are bound to the proteins of the fibrin; and
c) forming an image from the detected radiation.
9 . The device of claim 1 wherein the step of identifying venous outflow obstruction sites includes the steps of:
a) applying radionuclides that bind to proteins specific to fibrin, such as radionuclides bound to plasmin, other plasmids or any like substance that dissolves fibrin is bound to insulin-like growth factor (IGF) binding proteins (IGFBPs), preferably near where an obstruction is believed to be located;
b) detecting radiation emitted by the radionuclides that are bound to the proteins of the fibrin; and
c) forming an image from the detected radiation.
10 . The device of claim 9 wherein the plasmin, plasmid or other substance that dissolves fibrin is self-activated.
11 . The device of claim 9 wherein the plasmin, plasmid or other substance that dissolves fibrin is activated by the exposure to either a specific light frequency or by ultrasound at a specific frequency or any like energy source delivered either intravascularly or noninvasively.
12 . The device of claim 11 wherein the light or ultrasound or both is via the distal optics or transducer, respectively.
13 . The device of claim 1 wherein the step of assessing the nature of the stenotic lesion includes applying an imaging system to suspected areas of narrowing or flow disruption to identify intraluminal abnormalities including webs, flaps, inverted or incompetent valves and membranes as well as stenoses caused by plaque or the buildup of fibrin or thrombus.
14 . The device of claim 13 wherein the imaging system is selected from the group consisting of an IVUS system, an OCT system, and a combination IVUS and OCT system.
15 . The device of claim 14 wherein the step of determining the pressure gradient across the stenosis as compared to the superior vena cava is performed using either a manometer, pressure wire or any other blood pressure measuring device if the suspected significant venous stenosis/intraluminal abnormality is confirmed by any of the methods of step b.
16 . The device of claim 15 further including the step of communicating information on the pressure gradient to a healthcare provider.
17 . A Deep Vein Thrombosis diagnostic device comprising:
a pressure sensing device sized and shaped for insertion into a patient's veins;
a computing device in communication with the pressure sensing device, the computing device configured to perform the steps of:
identifying venous outflow obstruction sites in a peripheral vein;
assessing the nature of a stenotic lesion associated with at least one of the identified venous outflow obstruction sites in the peripheral vein; and
determining a pressure gradient across the stenosis as compared to the superior vena cava based on pressure measurements obtained by the pressure sensing device.
18 . The device of claim 17 , wherein the pressure sensing device is a guidewire.
19 . The device of claim 18 , wherein the step of identifying venous outflow obstruction sites in a peripheral vein includes sequentially accessing peripheral veins by selective venography at each of these sites to confirm or exclude a significant stenosis or flow disruption.
20 . The device of claim 18 , wherein the step of identifying venous outflow obstruction sites in a peripheral vein includes using transcutaneous echography applied to an accessible section of a peripheral vein to identify venous outflow obstruction sites and to confirm or exclude a significant stenosis or flow disruption at those sites.