Abstract
Chronic venous insufficiency is an advanced form of venous disease affecting more than 2.5 million patients in the United States of whom approximately 500,000 have venous leg ulcers. [1-3] A majority of these patients have an obstruction in the deep veins of the pelvis either alone or with venous valve reflux that leads to the development of chronic venous insufficiency. Such obstruction often extends for varying lengths above the groin, at times all the way up to the right atrial chamber of the heart. Pathology of such obstruction could be narrowing of the aforementioned veins or could be a complete blockage (occlusion). Such treatment involves use of stent to open up the obstruction going from an area of good venous blood inflow to an area of good venous blood outflow.
Claims
1. What is claimed are unimodular fenestrated venous stents that extend from the common femoral vein (below groin) to the right atrium (heart). I claim a form of venous stent(s) that maintains normal anatomic venous blood flow following treatment of venous obstruction by use of fenestrae at the same time reducing the number of stents required (and thereby complications) by using a single module. The claims defining the invention are for a unique form of venous stent configuration(s). What is put forth is an alternative to conventional venous stents.
2. While pursuing stenting for pelvic and/or abdominal deep venous obstruction on one side it is important not to block the flow of blood from the opposite side. This is so because the veins that drain the right leg / pelvis and the left leg / pelvis have separate anatomic routes till they fuse to one another to form the inferior vena cava. Any extension of the stent into the inferior vena cava without providing an adequate channel for blood flow from the opposite side leads to obstruction of blood from the latter. Such obstruction can result in development of venous disease on the opposite side including but not limited to blood clots warranting interventions on an otherwise asymptomatic side. These contralateral complications which arise from j ailing of the contralateral blood outflow can be prevented by use of a unimodular stent that has a fenestrum to provide outflow from the opposite side. Such a stent is represented in FIGS. 1 A-C. Given that the vein increases in size as it goes up from the groin all the way up to the iliac confluence (approximately at the level of the umbilicus), such a unimodular fenestrated stent should allow a gradual cranial increase in stent diameter to accommodate for this. Additionally, given that at times stenting has to be extended all the way to the right atrium, two separate modules are available to go along with this limb module. The first is a perirenal module that has two fenestrae for allowing blood flow out of the renal veins into the inferior vena cava, and a second perihepatic module that has a single fenestrum to allow for outflow of blood from the liver. The perirenal caval stent module (FIG. 2) is constructed so that it can be deployed into the upper part of the limb module or as a standalone device. The perihepatic caval stent module (FIG. 3) is also constructed to be deployed into the upper part of the renal module or as a standalone device. Configuration for the different stent modules is considered in Table I. The stent configurations have been arrived at from careful measurements of computed tomographic scans dedicated to look at venous anatomy that patients underwent prior to venous stenting. Comparison of such CT measurements to the current gold standard for imaging of venous obstruction - intravascular ultrasound has been done before and demonstrated to be accurate. Together, these three modules enable coverage of diseased vein all the way from below the groin to the level of the right atrium and enables treatment of the entire complement of obstructive venous disease including pelvic and abdominal deep veins. Such a modular configuration for treatment of obstructive venous disease is currently not available.
Description
8) DETAILED DESCRIPTION OF DRAWINGS
[0010] 9) FIG. 1A. - Prototype of a self-expanding woven unimodular femoroiliocaval stent design that can handle the iliocaval confluence. The stent is made by weaving together multiple wires made of alloy metal. There is a gradual taper in stent diameter from the inferior vena cava (IVC) to the common femoral vein. A side orifice that can be identified by radiopaque markers allows for contralateral outflow or contralateral stent deployment thereby reducing risk of development of contralateral symptoms and/or contralateral deep venous thrombosis (DVT). The left panel is a right sided stent, the middle panel is the undeployed stent within the delivery system with radiopaque markers identified and the right panel is a left sided stent.
[0011] 10) FIG. 1B. - Prototype of a self-expanding woven unimodular femoroiliocaval stent design that can handle the iliocaval confluence. The stent is made by weaving together multiple wires made of alloy metal. There is a gradual taper in stent diameter from the inferior vena cava (IVC) to the common femoral vein. A side orifice that can be identified by radiopaque markers allows for contralateral outflow or contralateral stent deployment thereby reducing risk of development of contralateral symptoms and/or contralateral deep venous thrombosis (DVT). The left panel is a right sided stent and the right panel is a left sided stent.
[0012] 11) FIG. 1C. Prototype of a single self-expanding woven daughter stent. The stent is made by weaving together multiple wires made of alloy metal. There is a gradual taper in stent diameter from the common iliac vein to the common femoral vein. The left panel is a right sided stent, and the right panel is a left sided stent.
[0013] 12) FIG. 1D. Prototype of a single self-expanding woven daughter stent without markings. The stent is made by weaving together multiple wires made of alloy metal. There is a gradual taper in stent diameter from the common iliac vein to the common femoral vein. The left panel is a right sided stent, and the right panel is a left sided stent.
[0014] 13) FIG. 1E. Iliocaval stent configuration post deployment of a right sided self-expanding woven parent iliocaval stent and a left sided self-expanding woven daughter stent. Descriptions of both stent types are noted in FIG. 1A through FIG. 1D.
[0015] 14) FIG. 2. Prototype of the self-expanding woven perirenal caval stent module. The stent is made by weaving together multiple wires made of alloy metal. The fenestrae on the two sides accommodate inflow from the right and left renal veins.
[0016] 15) FIG. 3. Prototype of the self-expanding woven perihepatic caval stent module. The stent is made by weaving together multiple wires made of alloy metal. The fenestrum accommodates inflow from the right, middle and left hepatic veins.
[0017] 16) Table 1. Stent configurations. Types I-II are femoro-ilio- caval configurations that allow for contralateral outflow/stenting. Lengths for femoro-ilio-caval stents allow for ~20 mm between the end of the stent and the original of the lowest renal vein. Stent extensions enable extending stent coverage in scenarios when the standard stent length comes short. Perirenal and perihepatic stent configurations are also depicted
