METHOD AND DEVICE FOR TREATMENT OF ARRHYTHMIAS AND OTHER MALADIES
Devices and methods are described for treating maladies such as atrial fibrillation. The devices and methods, in some implementations, include one or more rings formed of one or more windings. The rings provide mechanical pressure against an adjacent tissue, e.g., the tissue of a vessel, and the pressure works to inhibit the propagation of electrical signals along the vessel. The windings may be formed of a ribbon. Delivery systems are also provided.
1 . An implant device for treating atrial fibrillation, comprising:
a. a ring formed of at least one winding of a ribbon, wherein the width of the ribbon is between about 0.5 and 2.5 mm;
b. wherein in an undeployed configuration the diameter of the ring is between about 10 to 60 mm and wherein in a deployed configuration the diameter of the proximal ring is between about 10 to 30 mm;
c. and wherein the ring is configured to deliver a pressure against adjacent tissue when deployed of between about 0.01 N/mm 2 and 1.4 N/mm 2 .
2 . The implant device of claim 1 , wherein the ring includes at least 1.5 windings of the ribbon.
3 . The implant device of claim 1 , wherein the ring is configured to deliver a force against adjacent tissue when deployed of between about 0.02 N/mm 2 and 0.4 N/mm 2 .
4 . The implant device of claim 1 , wherein the width of the ribbon is between about 0.25 and 2 mm.
5 . The implant device of claim 1 , wherein the implant device is coated with a material composition, surface treatment, coating, or biological agent and/or drug.
6 . The implant device of claim 1 , wherein two rings are provided, each ring formed of at least one winding of a ribbon, wherein the width of the ribbon is between about 0.5 and 2.5 mm, wherein in an undeployed configuration the diameter of the ring is between about 10 to 60 mm and wherein in a deployed configuration the diameter of the proximal ring is between about 10 to 30 mm, and wherein the ring is configured to deliver a pressure against adjacent tissue when deployed of between about 0.01 N/mm 2 and 1.4 N/mm 2 , and wherein between the rings and extension arm is provided.
7 . The implant device of claim 1 , wherein a total force provided against adjacent tissue is between about 0.2 N and 10 N.
8 . The implant device of claim 7 , wherein a total force provided against adjacent tissue is between about 0.2 N and 6 N.
9 . The implant device of claim 1 , wherein the ribbon has a proximal end and a distal end, and wherein the proximal end and the distal end each define a hole therein.
10 . The implant device of claim 1 , wherein the ribbon has a rectangular cross-section.
11 . The implant device of claim 1 , wherein the ribbon has a curved rectangular cross-section.
12 . The implant device of claim 1 , further comprising a micro circuit disposed on the ribbon.
13 . The implant device of claim 12 , wherein the micro circuit is configured to wirelessly transmit a signal corresponding to a detected heart signal.
14 . The implant device of claim 13 , wherein the heart signal is indicative of heart rhythm.
15 . The implant device of claim 14 , wherein the heart signal is an EKG.
16 . A kit for treating a malady by deploying an implant device in a vessel, comprising
a. the implant device of claim 1 ; and
b. a delivery system.
17 . The kit of claim 16 , wherein the delivery system includes one or more electrodes on a distal end, the one or more electrodes for mapping, pacing, or ablating.
18 . The kit of claim 16 , wherein the delivery system comprises:
a. first means for attaching a proximal end of a ribbon to a first shaft;
b. second means for attaching a distal end of the ribbon to a second shaft, the second shaft movable with respect to the first shaft;
c. third means for releasing the proximal end; and
d. fourth means for releasing the distal end.
19 . The kit of claim 16 , wherein the kit includes at least four implant devices, each according to claim 1 .
20 . A method for treating a malady, comprising:
a. choosing a size of an implant device for insertion into a vein of a patient, the implant device including a ring formed of one or more windings of a ribbon, the ribbon having a width of between about 0.1 and 2.5 mm, and a diameter of between about 12 and 50 mm; and
b. inserting the implant device into the vein of the patient,
c. such that the choosing includes selecting the size of the implant device such that the implant device applies a pressure against in adjacent tissue, the pressure between about 0.01 N/mm 2 and 1.4 N/mm 2 .
21 . The method of claim 20 , wherein the malady is atrial fibrillation.
22 . The method of claim 20 , wherein the choosing includes selecting the size of the implant device such that the implant device applies a pressure against in adjacent tissue, the pressure between about 0.02 N/mm 2 and 0.4 N/mm 2 .
23 . A delivery device, comprising:
a. first means for attaching a proximal end of a ribbon to a first shaft;
b. second means for attaching a distal end of the ribbon to a second shaft, the second shaft movable with respect to the first shaft;
c. third means for releasing the proximal end; and
d. fourth means for releasing the distal end.
24 . The delivery device of claim 23 , wherein the second means includes a shaft and a cap and wherein a frictional fit is provided between the distal end of the ribbon and the shaft and the cap.
25 . The delivery device of claim 23 , wherein the first and second means are wires that engage holes defined in the proximal and distal ends of the ribbon.
26 . The delivery device of claim 24 , wherein the third and fourth means are sliders that engage the wires.
27 . The delivery device of claim 23 , further comprising a shaft defining a guide wire and delivery lumen.
28 . The delivery device of claim 23 , wherein the delivery device further comprises a distal tip, and further comprising electrodes disposed on the distal tip.
29 . The delivery device of claim 28 , wherein the electrodes are configured for mapping or ablating.
30 . The delivery device of claim 23 , wherein the third and fourth means are coupled, such that the proximal end and the distal end are released at substantially the same time.