ACUTE KIDNEY INJURY TREATMENT SYSTEMS AND METHODS

• US 20080221551A1
• Filed: 03/07/2008
• Published: 09/11/2008
• Est. Priority Date: 03/09/2007
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Patel, Samir R., Elkins, Jeffrey M., Goodson, Harry B.
• Application Number:
  US12/044,373
• Publication Number:
  US 20080221551A1
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026

Abstract

Systems and methods for the clinical treatment of individuals susceptible to or suffering from acute kidney injury are provided. Drugs, biologics, or other therapies or treatments are administered by fluid agent delivery directly to the kidneys via their arterial blood supply. Bifurcated renal artery infusion catheter devices and methods can treat kidney injury in patients with locally-delivered drugs, biologics, and other agents, so as to increase the ability of the kidneys to excrete nitrogenous waste products from the blood, and prevent or ameliorate azotemia.

Claims

1. A method for treating a patient suffering from acute kidney injury, comprising:

placing a bifurcated renal artery infusion catheter within the abdominal aorta of the patient, the bifurcated infusion catheter having a first renal delivery member with a first port and a second renal delivery member with a second port;

placing the first renal delivery member within a first renal artery of the patient, and placing the second renal delivery member within a second renal artery of the patient; and

delivering an amount of a therapeutic agent from a therapeutic agent source through the bifurcated renal artery infusion catheter and into the first and second renal arteries via the first and second ports, respectively,

wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an increase in serum creatinine by at least 50% over baseline, an absolute increase in serum creatinine of at least 0.3 mg/dL over baseline, a reduction in glomerular filtration rate of at least 25% compared to baseline, and a decrease in urine output to 0.5 ml per kilogram of body weight or less per hour persisting for at least 6 hours.

2. A method as in claim 1, wherein the therapeutic agent comprises a member selected from the group consisting of a vasodilator and an antioxidant.

3. A method as in claim 1, wherein the kidney injury was caused by a toxic agent selected from the group consisting of a radiocontrast media, a non-steroidal anti-inflammatory drug (NSAID), and a chemotherapy agent.

4. A method as in claim 1, wherein acute kidney injury comprises a pre renal kidney injury caused by a member selected from the group consisting of a reduced cardiac output leading to reduced overall blood flow to the kidneys, trauma, reduced blood oxygenation, systemic toxicity caused by reaction to injury in another organ, systemic hypotension resulting from cardiorenal syndrome or acute decompensated heart failure, a reduction in circulating volume due to hemorrhage, a surgical procedure, and a reduction in local renal blood flow resulting from hepatorenal syndrome.

5. A system as in claim 1, wherein the vasodilator comprises a member selected from the group consisting of fenoldopam mesylate or an analog or derivative thereof, dopamine or an analog or derivative thereof, and a prostaglandin or analog or derivative thereof, and wherein the antioxidant comprises a member selected from the group consisting of ascorbic acid, sodium bicarbonate, and acetylcysteine.

6. A method as in claim 1, wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an increase in serum creatinine by at least 100% over baseline, a reduction in glomerular filtration rate of at least 50% compared to baseline, and a decrease in urine output to 0.5 ml per kilogram of body weight or less per hour persisting for at least 12 hours.

7. A method as in claim 6, wherein the therapeutic agent comprises a member selected from the group consisting of a vasodilator, an antioxidant, an anti inflammatory agent, and an antibiotic agent.

8. A method as in claim 7, wherein the vasodilator comprises a member selected from the group consisting of fenoldopam mesylate or an analog or derivative thereof, dopamine or an analog or derivative thereof, and a prostaglandin or analog or derivative thereof, wherein the antioxidant comprises a member selected from the group consisting of ascorbic acid, sodium bicarbonate, and acetylcysteine, wherein the anti inflammatory agent comprises a P-38 kinase inhibitor, and wherein the antibiotic comprises a member selected from the group consisting of a bactericidal agent and a bacteriostatic agent.

9. A method as in claim 1, wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an increase in serum creatinine by at least 200% over baseline, an absolute serum creatinine rise of at least 0.5 mg/dL to a value of at least 4 mg/dL, a reduction in glomerular filtration rate of at least 75% compared to baseline, a decrease in urine output to 0.3 ml per kilogram of body weight or less per hour persisting for at least 24 hours, and a decrease in total urine output over 12 hours to 200 ml or less.

10. A method as in claim 9, wherein the therapeutic agent comprises a member selected from the group consisting of a vasodilator, an antioxidant, a diuretic, an anti inflammatory agent, an antibiotic, and a neurohormonally active agent.

11. A method as in claim 10, wherein the vasodilator comprises a member selected from the group consisting of fenoldopam mesylate or an analog or derivative thereof, dopamine or an analog or derivative thereof, and a prostaglandin or analog or derivative thereof, wherein the antioxidant comprises a member selected from the group consisting of ascorbic acid, sodium bicarbonate, and acetylcysteine, wherein the diuretic comprises hydrochlorothiazide (HCTZ), spironolactone, and a loop diuretic, wherein the antibiotic comprises a member selected from the group consisting of a bactericidal agent and a bacteriostatic agent, and wherein the neurohormonally active agent comprises a natriuretic peptide or an analog or derivative thereof.

12. A method as in claim 11, wherein the loop diuretic comprises furosemide, and wherein the natriuretic peptide comprises a member selected from the group consisting of A-type natriuretic peptide, B-type natriuretic peptide, C-type natriuretic peptide, a synthetic natriuretic peptide, and a bio-engineered natriuretic peptide.

13. A method as in claim 1, wherein the acute kidney injury is caused at least in part by a kidney tumor or cancer comprising a renal cell carcinoma, and the therapeutic agent comprises a member selected from the group consisting of a vasodilator, an antioxidant, an anti inflammatory agent, a cytokine, and a neurohormonally-active agent.

14. A method as in claim 13, wherein the vasodilator comprises a member selected from the group consisting of fenoldopam mesylate or an analog or derivative thereof, dopamine or an analog or derivative thereof, and a prostaglandin or analog or derivative thereof, wherein the antioxidant comprises a member selected from the group consisting of sodium bicarbonate and acetylcysteine, wherein the cytokine comprises a lymphokine, and wherein the neurohormonally active agent comprises a natriuretic peptide or an analog or derivative thereof.

15. A method as in claim 14, wherein the lymphokine comprises interleukin-2 or a genetically engineered or modified version thereof, and wherein the natriuretic peptide comprises a member selected from the group consisting of A-type natriuretic peptide, B-type natriuretic peptide, C-type natriuretic peptide, a synthetic natriuretic peptide, and a bio-engineered natriuretic peptide.

16. A system for treating a patient suffering from acute kidney injury, comprising:

a. a bifurcated renal artery infusion catheter placed via a percutaneous means, the bifurcated catheter comprising;

i. a distal bifurcated portion and a non-bifurcated proximal tubular portion;

ii. a catheter inner lumen traversing a length of the non-bifurcated proximal tubular portion of the infusion catheter;

iii. a first renal delivery member having a first distal port that is adapted to be delivered to a first delivery position within a first renal artery via a first corresponding renal ostium located at a first location along an abdominal aorta wall of an abdominal aorta in the patient;

iv. a second renal delivery member having a second distal port that is adapted to be delivered to a second delivery position within a second renal artery via a second corresponding renal ostium located at a second location along the abdominal aorta wall that is different than the first location;

v. a bifurcation joining the distal bifurcated portion and non-bifurcated proximal tubular portion of the catheter and providing for fluid communication between the first and second renal delivery members and the catheter inner lumen; and

vi. a proximal coupler assembly that is adapted to be located externally of the patient when the first and second distal ports are positioned at the first and second delivery positions, respectively, wherein the proximal coupler assembly is coupled with the catheter inner lumen so that material can be delivered from outside the patient'"'"'s body via the proximal coupler assembly, through the catheter inner lumen, through the first and second renal delivery members, through the first and second distal ports at the first and second delivery positions, respectively, and into the first and second renal arteries, also respectively;

b. a therapeutic agent source located externally to the patient; and

c. a mechanism that delivers the therapeutic agent through the bifurcated renal artery catheter via the proximal coupler to each of the first and second distal ports within first and second renal arteries,

wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an increase in serum creatinine by at least 50% over baseline, an absolute increase in serum creatinine of at least 0.3 mg/dL over baseline, a reduction in glomerular filtration rate of at least 25% compared to baseline, and a decrease in urine output to 0.5 ml per kilogram of body weight or less per hour persisting for at least 6 hours.

17. A system as in claim 16, wherein the therapeutic agent comprises a member selected from the group consisting of a vasodilator and an antioxidant.

18. A system as in claim 16, wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an increase in serum creatinine by at least 100% over baseline, a reduction in glomerular filtration rate of at least 50% compared to baseline, and a decrease in urine output to 0.5 ml per kilogram of body weight or less per hour persisting for at least 12 hours, and wherein the therapeutic agent comprises a member selected from the group consisting of a vasodilator, an antioxidant, an anti inflammatory agent, and an antibiotic agent.

19. A system as in claim 16, wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an increase in serum creatinine by at least 200% over baseline, an absolute serum creatinine rise of at least 0.5 mg/dL to a value of at least 4 mg/dL, a reduction in glomerular filtration rate of at least 75% compared to baseline, a decrease in urine output to 0.3 ml per kilogram of body weight or less per hour persisting for at least 24 hours, and a decrease in total urine output over 12 hours to 200 ml or less, and wherein the therapeutic agent comprises a member selected from the group consisting of a vasodilator, an antioxidant, an anti inflammatory agent, an antibiotic, and a neurohormonally active agent.

20. A system as in claim 16, wherein the acute kidney injury is caused at least in part by a kidney tumor or cancer comprising a renal cell carcinoma, and the therapeutic agent comprises a member selected from the group consisting of a vasodilator, an antioxidant, an anti inflammatory agent, a cytokine, and a neurohormonally-active agent.

21. A method for treating a patient suffering from acute kidney injury, comprising:

placing a bifurcated renal artery infusion catheter within the abdominal aorta of the patient, the bifurcated infusion catheter having a first renal delivery member with a first port and a second renal delivery member with a second port;

placing the first renal delivery member within a first renal artery of the patient, and placing the second renal delivery member within a second renal artery of the patient; and

delivering an amount of a therapeutic agent from a therapeutic agent source through the bifurcated renal artery infusion catheter and into the first and second renal arteries via the first and second ports, respectively,

wherein the acute kidney injury is characterized by at least one condition selected from the group consisting of an absolute increase in serum creatinine of more than 0.3 mg/dl within 48 hours, an increase in serum creatinine by at least 50% over baseline within 48 hours, and a decrease in urine output to 0.5 ml per kilogram of body weight or less per hour persisting for at least 6 hours.