Multi-lumen central access vena cava filter apparatus for clot management and method of using same
A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents and managing the capture of the clot thereafter.
1. A medical device system, comprising:
a. a multi-lumen catheter body having a first open port associated with a first fluid flow lumen and a second open port associated with a second fluid flow lumen;
b. an expandable filter member having a first end immovably coupled to the multi-lumen catheter body and a second end movable relative to the multi-lumen catheter body, the filter member being positioned substantially intermediate the first open port and the second open port such that the first open port is proximal the filter member and the second open port is distal the filter member, the filter member having a diametrically enlarged central opening which opens toward a patient's blood flow, at least one infusion port associated with at least one infusion lumen in the multi-lumen catheter body and positioned within an area of the multi-lumen catheter body bounded by the filter member, wherein the at least one infusion port further comprises a plurality of infusion ports arrayed along a longitudinal axis and a circumferential axis of the multi-lumen catheter body;
c. a compliant outer sheath coaxially disposed over the multi-lumen catheter body, having a circumference that radially expands around the expanded filter member containing a clot as the expanded filter member is contracted and translated into a lumen of the compliant outer sheath;
d. a temporary dilator coaxially disposable through one of the lumens of the multi-lumen catheter body, the temporary dilator being capable of increasing a diameter of a section of at least one of the lumens of the multi-lumen catheter body and the diameter of the compliant outer sheath, thereby accommodating retrieval of the expandable filter having an expanded diameter with a clot burden therein;
e. wherein the compliant outer sheath includes a plurality of longitudinal stripes disposed around the circumference of the compliant outer sheath, wherein the plurality of longitudinal stripes allows the compliant outer sheath to radially expand to a larger diameter as the expanded filter member is translated into the lumen of the compliant outer sheath; and
f. wherein the compliant outer sheath additionally includes a liner to control the expansion of the compliant outer sheath around the expanded filter member containing the clot in a contracted state diameter as the expanded filter member is translated into the lumen of the compliant outer sheath, wherein the liner includes a plurality of perforations that coaxially align with the plurality of longitudinal stripes.
2. The medical device system according to claim 1 , wherein the compliant outer sheath comprises an expandable frame including a plurality of linear slits to form an elastic matrix that expands around the expanded filter member containing the clot in the contracted state diameter as the expanded filter member is translated into the lumen of the compliant outer sheath.
3. The medical device according to claim 1 , further comprising means for filter monitoring.
4. The medical device according to claim 3 , wherein the means for filter monitoring comprises an optical coherence tomography or Doppler measurement device disposed through one of the lumens of the multi-lumen catheter body.