Method and device for treatment of hypertension and other maladies
Systems and methods for treating hypertension and other maladies are implemented using an implant device that is configured with one or more coils of ribbon which form ring-like structures when deployed in a patient's vasculature and are interconnected via respective extension arms formed from at least one helical winding. In an illustrative example, the catheter is positioned in the patient's aorta near the right angle junction with renal vasculature so that the axis of the catheter is substantially perpendicular to the axis of the vasculature. Through operation of an implant device delivery system having a pigtail distal end the ribbon emerges from the catheter tip and coils into the ring-like structures which deploy into the renal vasculature so that the longitudinal axes of the device and vasculature are substantially co-linear.
1. A method for treating hypertension in a human patient, the method comprising the steps of:
choosing a size of an implant device for insertion into a renal vasculature of the patient, the implant device comprising a single coiled ribbon wire having a proximal circumferential ring, a distal circumferential ring, and an extension arm connecting the proximal ring to the distal ring, wherein a plane of the proximal and distal circumferential rings are substantially perpendicular to the axis of the implant device;
inserting the ribbon wire into the renal vasculature of the patient in an uncoiled and substantially linear configuration within a delivery catheter;
advancing the uncoiled ribbon wire from a distal tip of the delivery catheter and coiling the proximal and distal circumferential rings within the renal vasculature, the proximal and distal circumferential rings providing radial outward compressive force along a circumference of the renal vasculature at each proximal and distal circumferential ring location along a portion of the renal vasculature; and
abrogating or lessening overactivity of the patient's renal sympathetic nervous system by the outward compressive force of the proximal and distal rings against the renal vasculature.
2. The method of claim 1 , wherein a diameter of the proximal ring is greater than the diameter of the distal ring.
3. The method of claim 1 , wherein a diameter of the proximal ring is substantially the same as the diameter of the distal ring.
4. The method of claim 1 , wherein in an undeployed configuration the diameter of the proximal ring is between about 4 to 60 mm and the diameter of the distal ring is between about 6 to 60 mm.
5. The method of claim 4 , wherein the diameters of the proximal ring and the distal ring are approximately 15 mm.
6. The method of claim 4 , wherein the diameter of the proximal ring is substantially 25 mm and the diameter of the distal ring is substantially 15 mm.
7. The method of claim 1 , wherein in a deployed configuration the diameter of the proximal ring is between about 2 to 40 mm and the diameter of the distal ring is between about 3 to 40 mm.
8. The method of claim 1 , wherein the proximal and distal rings are chosen such that at least one ring is 10-50% oversized compared to a vessel in which the implant device is implanted.
9. The method of claim 1 , wherein the ring is configured to, when deployed, deliver a force against adjacent tissue of between about 0.5 g/mm 2 and 340 g/mm 2 .
10. The method of claim 9 , wherein the ring is configured to, when deployed, deliver a force against adjacent tissue of between about 20 g/mm 2 and 200 g/mm 2 .
11. The method of claim 1 , wherein the proximal ring is configured to deliver a lesser force when deployed against adjacent tissue than the distal ring.
12. The method of claim 1 , wherein the rings are configured to deliver a force against adjacent tissue when the implant device is deployed of between about 5 g/mm 2 and 340 g/mm 2 .
13. The method of claim 1 , wherein the rings configured to deliver a force against adjacent tissue when the implant device is deployed of between about 20 g/mm 2 and 200 g/mm 2 .
14. The method of claim 1 , wherein the force is sufficient to cause necrosis or apoptosis in the adjacent tissue, the necrosis or apoptosis sufficient to block or delay electrical conduction.
15. The method of claim 1 , wherein an extremity of a ring is shaped to increase frictional or mechanical resistance against movement.
16. The method of claim 1 , wherein the implant device is coated with a material composition, surface treatment, coating, or biological agent and/or drug.
17. A method for treating hypertension in a human patient, the method comprising the steps of:
choosing a size of an implant device for insertion into a renal vasculature of the patient, the implant device comprising a single coiled ribbon wire having proximal and distal circumferential rings substantially perpendicular to the axis of the implant device connect by an extension arm, each ring having at least one winding of the ribbon wire;
inserting the ribbon wire into the renal vasculature of the patient in an uncoiled and substantially linear configuration within a delivery catheter;
advancing the uncoiled ribbon wire from a distal tip of the delivery catheter and coiling the proximal and distal circumferential rings within the renal vasculature so that the proximal and distal circumferential rings assume a radially deployed orientation, the proximal and distal circumferential rings providing radial outward compressive force on adjacent tissue of the renal vasculature at each proximal and distal circumferential ring location; and
blocking or delaying electrical signals traveling along the axis of the renal vasculature by the compressive force of the proximal and distal rings against the adjacent tissue to thereby cause one or more renal nerves associated with the renal vasculature to be at least partially denervated.
18. The method of claim 17 further including a step of applying thermal energy through the implant device to adjacent tissue using inductive heating.
19. The method of claim 17 further including a step of ablating surrounding tissue through application of heat or RF emissions.
20. The method of claim 17 further including a step of applying cryothermia therapy.
21. A method for treating hypertension in a human patient, the method comprising the steps of:
inserting an undeployed implant device in an uncoiled and substantially linear configuration within a delivery catheter into the patient through a blood vessel, the implant device having a shape when coiled comprising a single ribbon wire having proximal and distal circumferential rings substantially perpendicular to the axis of the implant device connect be an extension arm, the proximal and distal rings having at least one circumferential winding of the ribbon wire;
positioning the implant device adjacent to a renal nerve of at least one kidney of the patient;
deploying the uncoiled and substantially linear ribbon wire from the distal tip of the delivery catheter and coiling the proximal and distal circumferential rings within the blood vessel so that the proximal and distal circumferential rings exert a radially outward circumferential force to a portion of the blood vessel at each proximal and distal ring location; and
de-stimulating or at least partially denervating the renal nerve by the radially outward circumferential force of the proximal and distal rings against the blood vessel.
22. A method of implementing catheter-based renal denervation in a human patient having a renal artery, the method comprising the steps of:
delivering an undeployed implant device using a catheter inserted in the patient's femoral artery, the undeployed implant device being uncoiled and arranged in the catheter in a substantially linear configuration and having a shape when deployed comprising a single coiled ribbon wire having proximal and distal circumferential rings connect by an extension arm, wherein a plane of the proximal and distal circumferential rings are substantially perpendicular to the axis of the implant device;
advancing the catheter so that the implant device is positioned at a selected location in the renal artery;
deploying the uncoiled and substantially linear ribbon wire from the catheter tip, the proximal and distal circumferential rings coiling so that the proximal and distal circumferential rings exert a radially outward circumferential force along at each proximal and distal ring location; and
denervating portions of efferent sympathetic renal nerves or sensory afferent renal nerves encasing the renal artery by the radially outward circumferential force of the proximal and distal rings against the renal artery so as to cause a reduction in sympathetic nervous system drive.
23. A method of treating a malady, the method comprising the steps of:
delivering an undeployed implant device using a catheter inserted in a patient, the undeployed implant device being uncoiled and arranged in the catheter in a substantially linear configuration and having a shape when deployed comprising a single coiled ribbon wire having proximal and distal contiguous circumferential rings substantially perpendicular to the axis of the implant device connect by an extension arm, the proximal and distal rings having at least one winding of a ribbon wire;
advancing the catheter so that the implant device is positioned at a targeted selected location in the patient's anatomy; and
deploying the uncoiled and substantially linear ribbon wire from the catheter tip, the ribbon wire coiling so that the proximal and distal circumferential rings exert a radially outward circumferential force along at each proximal and distal ring location; and
partially blocking electrical signals traveling along the targeted location or to at least partially denervating along the circumference at the proximal and distal ring locations by the outward compressive force of the proximal and distal rings against the selected location.
24. The method of claim 23 , wherein the targeted location comprises the patient's stomach and the catheter is fed through the patient's esophagus.
25. The method of claim 23 , wherein the targeted location comprises a distal renal artery and the catheter is fed through the patient's femoral artery.