Bi-lateral local renal delivery for treating congestive heart failure and for BNP therapy

• US 20050267010A1
• Filed: 05/13/2005
• Published: 12/01/2005
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Patel, Samir R., Ball, Craig A., Elkins, Jeffrey M., Goodson, Harry Burt
• Granted Patent: US 7,585,836 B2
• Time in Patent Office: Days
• US Class Current: 514/12.400
• CPC Class Codes: A61K 38/2242 Atrial natriuretic factor complex: Atriopeptins, atrial natriuretic protein [ANP]; Cardionatrin, Cardiodilatin
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The invention relates to systems and methods for local renal delivery of agents to subjects that are at risk for congestive heart failure and other conditions. The invention encompasses devices for renal drug delivery and methods of use.

Claims

1. A method comprising:

locally administering a natriuretic peptide into at least one renal artery of a patient.

2. A method as in claim 1, wherein the natriuretic peptide is locally delivered into both renal arteries of the patient.

3. A method as in claim 2, wherein the local delivery into both renal arteries occurs simultaneously.

4. A method as in claim 1, wherein the patient is at risk of developing at least one condition selected from the group consisting of congestive heart failure, dyspnea, elevated pulmonary capillary wedge pressure, chronic renal insufficiency, acute renal failure, cardiorenal syndrome, and diabetes mellitus.

5. A method as in claim 1, wherein the patient is suffering from least one condition selected from the group consisting of congestive heart failure, dyspnea, elevated pulmonary capillary wedge pressure, chronic renal insufficiency, acute renal failure, cardiorenal syndrome, and diabetes mellitus.

6. A method as in claim 1, wherein the peptide is administered under conditions selected to reduce the risk of systemic side effects including hypotension.

7. A method as in claim 1, wherein the peptide is delivered in form of a drug or pharmaceutical composition.

8. A method as in claim 7, wherein the drug is delivered in bolus form at a dosage of about 1 to 5 mcg/kg.

9. A method as in claim 7, wherein the drug is delivered via continuous administration at a dosage of about 0.005 to 0.05 mcg/kg/min.

10. A method as in claim 7, wherein the drug is delivered through a bolus form at a dosage of about 1 to 5 mcg/kg in combination with continuous administration at a dosage of about 0.005 to 0.05 mcg/kg/min.

11. A method as in claim 1, wherein the natriuretic peptide is selected from the group consisting of BNP, ANP, and CNP.

12. A method comprising:

positioning an intravascular catheter through an aorta so that at least one delivery port is positioned in at least one renal artery; and

delivering an active substance through said intravascular catheter to said at least one renal artery;

wherein the catheter comprises a compliant region which accommodates tension or compression resulting from patient movement when the catheter is positioned in the aorta and the delivery port is in the at least one renal artery.

13. A method as in claim 12, wherein the compliant region is non-linear and comprises a coil structure, a serpentine structure, or a zig-zag structure.

14. A method as in claim 12, wherein the complaint region has a stiffness less that than of adjacent regions to permit slackness in the region after deployment in the aorta.

15. A method as in claim 14, wherein the positioning comprises:

straightening the compliant region with a stylet disposed within a lumen of the catheter;

advancing the catheter through the aorta while the catheter remains straightened with the stylet; and

withdrawing the stylet from the compliant region to allow the compliant region to assume its non-linear configuration.

16. A method as in claim 15, wherein the active substance comprises a natriuretic peptide.

17. A method as in claim 16, wherein the natriuretic peptide is selected from the group consisting of BNP, ANP, and CNP.

18. A method as in claim 16, wherein the natriuretic peptide is delivered in bolus form at a dosage of about 1 to 5 mcg/kg.

19. A method as in claim 16, wherein the natriuretic peptide is delivered via continuous administration at a dosage of about 0.005 to 0.05 mcg/kg/min.

20. A method as in claim 16, wherein the drug is delivered through a bolus form at a dosage of about 1 to 5 mcg/kg in combination with continuous administration at a dosage of about 0.005 to 0.05 mcg/kg/min.

21. A renal drug delivery catheter, said catheter comprising:

a catheter body having a proximal end, a distal end, and a drug delivery lumen therethrough; and

a hub on the proximal end adapted to deliver drugs to the drug delivery lumen;

wherein the distal end of the catheter body is adapted to enter a renal artery when the catheter body is located in an adjacent aorta; and

wherein a portion of the catheter body is compliant and configured to accommodate tension or compression resulting from patient movement when the catheter body is in the aortic and the distal end is in the renal artery.

22. A renal drug delivery catheter as in claim 21, wherein said portion is non-linear and has a coil, serpentine, or zig-zag geometry over a length.

23. A renal drug delivery catheter as in claim 21, wherein the compliant section has a stiffness that is less than that of adjacent regions of the catheter so that the complaint section is slack and can be loosely deployed to accommodate tension and elongation after placement.

24. A renal drug delivery catheter as in claim 21, further comprising a stylet which can be placed in a lumen during delivery to straighten the compliant portion.