Devices And Methods For Renal Denervation
Devices and methods that produce alterations of renal sympathetic nerve activity by use of tissue modifying implants. Devices for percutaneous delivery of implants into a renal artery or vein wall employing various needle assembly arrangements to modify renal nerve activity.
1 . A method for renal denervation comprising creating a remodeled zone that spans a complete closed loop around a vessel carrying renal nerves.
2 . The method of claim 1 wherein creating a remodeled zone comprises delivering a plurality of bioactive implants in proximity to renal nerves.
3 . The method of claim 2 wherein delivering a plurality of bioactive implants in proximity to renal nerves comprises injecting a plurality of implants into tissue in proximity to renal nerves.
4 . The method of claim 3 wherein injecting a plurality of implants into tissue in proximity to renal nerves comprises:
navigating a catheter to a target site, said catheter carrying at least one flexible needle containing at least one of said implants;
advancing said at least one needle from said catheter into said tissue;
ejecting said implants from said at least one needle.
5 . The method of claim 4 wherein ejecting said implants from said at least one needle comprises retracting said needle while maintaining a position of said implants relative to said tissue.
6 . The method of claim 4 wherein advancing said at least one needle from said catheter into said tissue comprises advancing said at least one needle from said catheter at an outward angle from a longitudinal axis of said catheter.
7 . The method of claim 2 wherein delivering a plurality of bioactive implants comprises delivering a plurality of bioactive implants, each of said implants including a material selected from the group consisting of sclerosants, neurotoxins, polymers, and metals.
8 . A device for use in renal denervation comprising:
a catheter having a plurality of lumens;
a needle contained within each lumen and moveable longitudinally relative to said catheter, each needle defining a needle lumen; and
a holding rod slideably disposed within each needle lumen;
wherein each of said needles may be retracted relative to said holding rods such that one or more implants contained in a distal end of said needle lumen is ejected from said needle lumen by said holding rod when said needle is retracted.
9 . The device of claim 8 wherein each of said plurality of lumens exits a distal end of said catheter at an angle to a longitudinal axis of said catheter such that when said needles are extended from said distal end, said needles radiate outwardly from said catheter.
10 . The device of claim 8 wherein said catheter comprises four lumens radially spaced ninety degrees apart from adjacent lumens.
11 . The device of claim 9 wherein each of said needles comprise a preformed curve such that, upon exiting said lumens, each of said needles curves outwardly.
12 . The device of claim 8 wherein each of said plurality of lumens is parallel to a longitudinal axis of said catheter and wherein each of said needles comprise a preformed curve such that, upon exiting said lumens, each of said needles curves outwardly from said longitudinal axis.
13 . The device of claim 8 wherein each of said needles comprise a preformed spiral shape that is straightened when said needles are contained within said plurality of lumens but resumed when said needles exit distal ends of said lumens.
14 . A device for use in renal denervation comprising:
a catheter defining a catheter lumen;
a plurality of needles slidably disposed within said catheter lumen;
at least one implant contained in a distal end of each of said plurality of needles;
a radiating mechanism for causing said needle to extend at an angle away from a longitudinal axis of said catheter when said needle is deploying said implant.
15 . The device of claim 14 wherein said radiating mechanism comprises:
a coil element assembly disposed within said catheter lumen and moveable from a delivery position wherein said coil element assembly has a constrained configuration within said catheter lumen, to a deployed configuration wherein said coil element assembly extends from a distal end of said catheter lumen and expands to assume a coil shape;
wherein said coil element assembly defines a coil lumen and includes:
said plurality of needle elements slidably contained within said coil lumen;
a plurality of exit holes leading from said coil lumen, wherein each of said needle elements has a distal end that, when said needle element is advanced, extends through one of said exit holes.
16 . The device of claim 14 wherein said radiating mechanism comprises exit holes defined in a sidewall of said catheter, each of said plurality of needles directed out of said exit holes when advanced.
17 . The device of claim 14 wherein said radiating mechanism comprises a balloon disposed between said plurality of needles near a distal end thereof such that, upon inflation, said balloon pushes each of said needles outwardly.
18 . The device of claim 14 wherein said radiating mechanism comprises preformed curves in each of said plurality of needles.
19 . The device of claim 14 wherein said radiating mechanism comprises a malecot element assembly including a plurality of wings, each wing containing one of said plurality of needle elements.
20 . The device of claim 19 wherein said malecot element assembly comprises nitinol.