Deep Vein Thrombosis Therapeutic Methods Using Therapeutic Inflatable Occlusive Devices 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 method of treating Deep Vein Thrombosis, comprising:
providing a treatment device having 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 system with at least an imaging transducer located at the distal end of the balloon catheter 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 and wherein the imaging system includes virtual histology (VH) technology to help the physician recognize and identify the morphology of tissue, particularly plaque associated with a lesion, in vivo; and
applying the treatment device to an indentified venous outflow obstruction site of a peripheral vein, including visualizing the identified venous outflow obstruction site with the imaging transducer and inflating the balloon adjacent to the identified venous outflow obstruction site to increase a cross-sectional area of a lumen of the peripheral vein.
2 . The method of claim 1 , wherein the provided balloon is a cutting or scoring balloon.
3 . The method of claim 1 , wherein the provided balloon is a non-compliant balloon.
4 . The method of claim 1 , wherein the provided balloon is sized and shaped to occupy at least about 80 % of a healthy cross-sectional area of a vein into which the balloon will be inserted.
5 . The method of claim 1 , wherein the provided balloon is a one-piece balloon.
6 . The method of claim 1 , wherein the provided balloon is porous to a treatment agent to allow the treatment agent contained within the balloon to be exuded from the balloon.
7 . The method of claim 1 , wherein the provided balloon includes a plurality of openings to allow a treatment agent contained within the balloon to be exuded from the balloon.
8 . The method of claim 7 , further comprising providing a treatment agent positioned within the balloon, the treatment agent selected from the group of treatment agents consisting of tissue plasminogen activator, urokinase, streptokinase, collagenace, and hepranoid.
9 . The method of claim 1 , wherein the provided imaging transducer is positioned at the distal tip of the catheter.
10 . The method of claim 1 , wherein the central lumen of the provided catheter body extends to the ultimate distal end of the catheter body.
11 . A Deep Vein Thrombosis therapeutic method, comprising:
providing a treatment device that includes:
a catheter having a proximal portion, a distal portion, a central lumen extending along a length of the catheter between the proximal and distal portions, and an off-set lumen extending along the length of the catheter between the proximal and distal portions;
an occlusive balloon coupled to the distal portion of the catheter such that a distal tip of the occlusive balloon is spaced from a distal tip of the catheter, the occlusive balloon in fluid communication with the off-set lumen of the catheter; and
an imaging element coupled to the distal portion of the catheter, the imaging element being part of an imaging system that allows a user to identify intravascular stenoses and includes a virtual histology (VH) application that provides representations of the detected tissue types based on data received from the imaging element;
applying the treatment device to an indentified venous outflow obstruction site of a peripheral vein, wherein applying the treatment device includes visualizing the identified venous outflow obstruction site with the imaging element and inflating the occlusive balloon adjacent to the identified venous outflow obstruction site to increase a cross-sectional area of a lumen of the peripheral vein.
12 . The method of claim 11 , wherein the provided balloon is a cutting or scoring balloon.
13 . The method of claim 11 , wherein the provided balloon is a non-compliant balloon.
14 . The method of claim 11 , wherein the provided balloon is sized and shaped to occupy at least about 80% of a healthy cross-sectional area of a vein into which the balloon will be inserted.
15 . The method of claim 11 , wherein the provided balloon is a one-piece balloon.
16 . The method of claim 11 , wherein the provided balloon is porous to a treatment agent to allow the treatment agent contained within the balloon to be exuded from the balloon.
17 . The method of claim 11 , wherein the provided balloon includes a plurality of openings to allow a treatment agent contained within the balloon to be exuded from the balloon.
18 . The method of claim 11 , wherein the provided imaging element is at least one ultrasound transducer.
19 . The method of claim 11 , wherein the provided imaging element is at least one optical coherence tomography imaging element.
20 . The method of claim 11 , wherein the provided imaging element is positioned at the distal tip of the catheter.