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

• US 7,585,836 B2
• Filed: 05/13/2005
• Issued: 09/08/2009
• Est. Priority Date: 05/14/2004
• Status: Expired due to Fees

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: Elkins, Jeffrey M., Goodson, Harry Burt IV, Patel, Samir R., Ball, Craig A.
• Primary Examiner(s): Kosar; Andrew D
• Assistant Examiner(s): GUDIBANDE, SATYANARAYAN R
• Application Number:
  US11/129,101
• Publication Number:
  US 20050267010A1
• Time in Patent Office: 1,579 Days
• Field of Search: None
• US Class Current: 514/1.1
• 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:

placing a bifurcated renal infusion catheter within a patient, such that a first distal infusion branch of the catheter is disposed within a first renal artery and a second distal infusion branch of the catheter is disposed within a second renal artery; and

locally administering a natriuretic peptide into both renal arteries of the patient via the bifurcated renal infusion catheter,

wherein the patient is at risk of developing or is suffering from 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.

2. The method as in claim 1, wherein the local delivery into both renal arteries occurs simultaneously.

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

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

5. The method as in claim 4, wherein the drug is delivered in bolus form at a dosage of about 1 to 5 mcg/kg.

6. The method as in claim 4, wherein the drug is delivered via continuous administration at a dosage of about 0.005 to 0.05 mcg/kg/min.

7. The method as in claim 4, 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.

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

19. The method as in claim 1, wherein the patient is suffering from acute renal failure.

20. The method as in claim 1, wherein the patient is at risk of developing acute renal failure.

21. The method as in claim 1, wherein the patient has a serum creatinine level above baseline.

9. The method of treating a patient comprising:

bilaterally cannulating both renal arteries of a patient with a bifurcated renal infusion catheter, such that a first distal infusion branch of the infusion catheter is disposed within a first renal artery of the patient and a second distal infusion branch of the infusion catheter is disposed within a second renal artery of the patient; and

locally administering a natriuretic peptide into both renal arteries of the patient via a bifurcated renal infusion catheter,

wherein the patient is at risk of developing or is suffering from 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.

10. The method as in claim 9, 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.

11. The method as in claim 9, 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.

12. The method as in claim 9, wherein the peptide is administered under conditions selected to reduce the risk of systemic side effects including hypotension.

13. The method as in claim 9, wherein the peptide is delivered in form of a drug or pharmaceutical composition.

14. The method as in claim 13, wherein the drug is delivered in bolus form at a dosage of about 1 to 5 mcg/kg.

15. The method as in claim 13, wherein the drug is delivered via continuous administration at a dosage of about 0.005 to 0.05 mcg/kg/min.

16. The method as in claim 13, 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.

17. The method as in claim 9, wherein the natriuretic peptide is selected from the group consisting of BNP, ANP, and CNP.

22. The method as in claim 9, wherein the patient is suffering from acute renal failure.

23. The method as in claim 9, wherein the patient is at risk of developing acute renal failure.

24. The method as in claim 9, wherein the patient presents a percentage rise in serum creatinine of at least 25% or an absolute rise in serum creatinine of at least 0.5 mg/dl, or both, within 72 hours.

18. The method of treating a patient comprising:

locally administering a natriuretic peptide into both renal arteries of the patient via a bifurcated renal infusion catheter,

wherein the patient is at risk of developing or is suffering from 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.

25. The method as in claim 18, wherein the patient is suffering from acute renal failure.

26. The method as in claim 18, wherein the patient is at risk of developing acute renal failure.

27. The method as in claim 18, wherein the patient presents a percentage rise in serum creatinine of at least 25% or an absolute rise in serum creatinine of at least 0.5 mg/dl, or both, within 72 hours.