PREVENTING NON-TARGET EMBOLIZATION
Devices, methods and kits for preventing or reducing non-target microparticles deposition and embolization, in conjunction with delivering microparticles (e.g., embolization material) via a blood vessel to a target bodily part. Applicable for entrapping infiltrated microparticles within heart right atrium. Entrapping device includes: filter; and filter collapsing mechanism sized for positioning in catheter lumen of a filter delivering catheter, and having proximal end actuatable from outside of subject. Filter configured for positioning within heart right atrium, for self-expanding and covering right atrium inlet opening, and configured, when expanded, to collect embolic material delivered to target organ and infiltrated into outflow vessel thereof draining to right atrium. Filter collapsing mechanism configured for collapsing, and being manipulated to form a pocket in filter, to entrap collected embolic material therein, and drawing filter with collected embolic material in pocket, into catheter lumen of filter delivering catheter.
1 . An entrapping device for preventing or reducing non-target deposition of embolic material following embolization therapy in a blood vessel feeding a target organ in a subject, the entrapping device comprising:
a filter; and
a filter collapsing mechanism, sized for being positioned in a catheter lumen of a filter delivering catheter, and having a proximal end actuatable from outside of the subject;
wherein said filter is configured for positioning within a heart right atrium via an inlet opening of said right atrium, and, for self-expanding and covering said right atrium inlet opening from within said right atrium, and is sized and configured such that, when expanded, said filter collects the embolic material delivered to the target organ and infiltrated into an outflow vessel of the target organ draining to said right atrium; and
wherein said filter collapsing mechanism is configured for collapsing, and for being manipulated into forming a pocket in said filter, so as to entrap said collected embolic material in said pocket, and for drawing said filter with said collected embolic material in said pocket, into said catheter lumen of said filter delivering catheter.
2 . The entrapping device according to claim 1 , wherein said filter collapsing mechanism includes: an elongated tubular body connectable with a distal end to said filter; and
a drawstring extendable from an opened proximal perimeter of said filter to outside of the subject, wherein said drawstring is passable within said elongated tubular body;
wherein said filter collapsing mechanism is configured for said collapsing and said being manipulated by pulling said drawstring away from said filter against said elongated tubular body.
3 . The entrapping device according to claim 1 , wherein said filter has a cap-shape structure sized and configured to seal said inlet opening of said heart right atrium.
4 . The entrapping device according to claim 1 , further comprising a hollow circumferential sleeve connected about a proximally opened perimeter of said filter and configured for housing said drawstring at said proximally opened perimeter of said filter.
5 . The entrapping device according to claim 1 , wherein said filter delivering catheter is configured for housing said entrapping device in a collapsed configuration.
6 . The entrapping device according to claim 1 , wherein said filter comprises a fine mesh having strands with a thickness of about 200 micrometers or less, or optionally particularly about 100 micrometers or less.
7 . The entrapping device according to claim 1 , wherein said filter comprises pores configured to block passage therethrough of the embolic material and to allow passage therethrough of incoming blood flow.
8 . The entrapping device according to claim 1 , wherein the embolic material has a diameter equal to or greater than a predetermined size; wherein said predetermined size is within a range of between about 20 micrometers and about 60 micrometers.
9 . (canceled)
10 . The entrapping device according to claim 1 , configured for collecting the embolic material in a form of: beads, foam, or gel; wherein said beads are loaded with a radioactive agent or a chemotherapeutic agent.
11 . (canceled)
12 . A method of applying multi-layered protection from non-target embolization or/and non-target deposition of microparticles in a subject, the method comprising:
positioning an entrapping device in a first anatomical location downstream to a target organ, said entrapping device is configured to filter the microparticles from blood flow and to entrap the microparticles; placing a distal outlet of a microcatheter in a second anatomical location upstream to said target organ;
delivering an infusion suspension including the microparticles via said distal outlet in said second anatomical location upstream to, and towards, said target organ, while allowing a continuous blood flow downstream towards and away from said target organ, by applying a flow disturbance mechanism in said second anatomical location, proximally to said microcatheter distal outlet, thereby creating a local disturbance in blood flow so as to suppress a retrograded flow of the microparticles flowable upstream to said target organ; and
removing said entrapping device from the subject following a chosen time, after ceasing of said delivering, sufficient for allowing said entrapping device to entrap infiltrating microparticles infiltratable upstream through said flow disturbance mechanism or/and downstream to said target organ.
13 . The method according to claim 12 , wherein the microparticles include, or are included in, embolic material, and are configured for forming emboli.
14 . The method according to claim 13 , wherein said chosen time is additionally sufficient for allowing the microparticles to form an embolus in a target blood vessel feeding said target organ, said embolus is sized for occluding said target blood vessel.
15 . A method for performing local embolization in a blood vessel feeding a target organ in a subject, the method comprising:
positioning an entrapping device within a heart right atrium via an inlet opening of said right atrium, said entrapping device is configured to filter embolic material from blood flow, and to entrap said embolic material;
deploying said entrapping device to thereby cover said inlet opening of said right atrium from within said right atrium;
placing a distal outlet of a microcatheter in the blood vessel feeding the target organ;
delivering said embolic material via the distal outlet in the blood vessel towards the target organ; and
removing said entrapping device from the subject following a chosen time after ceasing of said delivering, sufficient for allowing said entrapping device to entrap said embolic material that has passed into said heart right atrium.
16 . The method according to claim 15 , wherein said placing said distal outlet of said microcatheter in the blood vessel is performed concomitantly with, following, or before said positioning said entrapping device in the blood vessel.
17 . The method according to claim 15 , wherein said positioning said entrapping device, comprises: providing a catheter having a proximal end, a distal end, and a lumen extending therebetween said ends, said catheter is configured for housing said entrapping device in a collapsed configuration; and inserting said catheter into said heart right atrium.
18 . A kit for preventing non-target deposition of embolic material, said kit comprising an entrapping device configured for capturing the embolic material within a blood vessel, downstream to a target organ or a non-target organ, and a microcatheter configured for delivering the embolic material into said blood vessel feeding a bodily organ; wherein said entrapping device comprises:
a collapsible filter, an elongated tubular body connected with a distal end to said filter and actuatable with a proximal end thereof from outside the subject body, and a drawstring extended from an opened proximal perimeter of said filter and continuously threaded within an inner lumen of said elongated tubular body;
said filter is configured for positioning within a heart right atrium via an inlet opening of said right atrium, and for self-expanding and covering said right atrium inlet opening from within said right atrium, and is sized and configured for collecting the embolic material delivered to the target organ and infiltrated into an outflow vessel of said target organ draining to said right atrium;
said drawstring is configured for re-collapsing said filter into forming a pocket, by proximally pulling said drawstring, so as to entrap said collected embolic material in said pocket; and
said elongated tubular body is configured for drawing said filter, with said embolic material in said pocket, into a lumen of a catheter.
19 . (canceled)
20 . The kit according to claim 18 , wherein said filter has a cap-shape structure configured to seal said inlet opening of said heart right atrium.
21 . The kit according to claim 18 , further comprising a hollow circumferential sleeve connected about a proximally opened perimeter of said filter and configured for housing said drawstring at said proximally opened perimeter of said filter.
22 . The kit according to claim 18 , wherein said catheter is configured for housing said entrapping device in a collapsed configuration.
23 . The kit according to claim 18 , wherein said filter comprises a fine mesh having strands with a thickness of no more than 200 micrometers.
24 . The kit according to claim 18 , wherein said filter comprises pores configured to block passage therethrough of an embolic material and to allow passage therethrough of incoming blood flow; wherein said embolic material is having a diameter that equals to or greater than a predetermined size within the range of between 20 micrometers and 60 micrometers.
25 . (canceled)
26 . (canceled)
27 . The kit according to 26 , wherein said catheter is an embolization microcatheter configured to reduce reflux of the embolic material, during continuous delivery thereof in a subject; wherein said embolization microcatheter comprises:
a tubular wall having a proximal wall end, a distal wall end, and a lumen extending between said wall ends, said lumen is opened to a distal outlet at said distal wall end and to a plurality of side openings distributed around or/and along a section of said tubular wall proximally to said distal outlet;
said embolization microcatheter is configured to deliver an infusion suspension of the embolic material in an infusion fluid, via said lumen to said distal outlet;
wherein said distal outlet is shaped or/and sized to allow passage therethrough of said infusion suspension of said infusion fluid and the embolic material, and each of said side openings is shaped or/and sized to allow passage therethrough of said infusion fluid without the embolic material and to block passage therethrough of the embolic material; wherein at least one of said side openings comprises a slit with a gap having a maximal cross sectional dimension less than a minimal diameter of the embolic material.
28 . (canceled)
29 . (canceled)
30 . (canceled)
31 . The kit according to claim 18 , further comprising a vial containing the embolic material.