RENAL ASSESSMENT SYSTEMS AND METHODS

• US 20090105799A1
• Filed: 10/22/2008
• Published: 04/23/2009
• Est. Priority Date: 10/23/2007
• Status: Abandoned Application

• Current Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Valencia, Aurelio, Altamura, Frank, Hekmat, Neema, Elkins, Jeff, Goodson, Burt, Yin, Courtney
• Application Number:
  US12/256,154
• Publication Number:
  US 20090105799A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

Techniques for assessing a physiological profile of a patient include advancing a catheter shaft of a bifurcated renal catheter system into an aorta of the patient, deploying branches of the bifurcated renal catheter system into the renal arteries of the patient, detecting a renal arterial physiological parameter with a sensing mechanism, and assessing the physiological profile of the patient based on the physiological parameter. Related techniques include modifying or initiating pharmacological or surgical treatments for the patient based on the assessment.

Claims

1. A method of assessing a physiological profile of a patient, comprising:

advancing a catheter shaft of a bifurcated renal catheter system into an aorta of the patient;

deploying a first catheter branch of the bifurcated renal catheter system into a first renal artery of the patient, and a second catheter branch of the bifurcated renal catheter system into a second renal artery of the patient;

detecting a physiological parameter of the first renal artery, and optionally detecting a physiological parameter of the second renal artery, with a sensing mechanism of the bifurcated renal catheter system; and

assessing the physiological profile of the patient based on the physiological parameter of the first renal artery, on the physiological parameter of the second renal artery, or on the physiological parameter of the first renal artery and the physiological parameter of the second renal artery.

2. The method according to claim 1, wherein the first catheter branch comprises a first branch sensing element, and the second catheter branch comprises a second branch sensing element, the method further comprising detecting the physiological parameter of the first renal artery with the first branch sensing element, and optionally detecting the physiological parameter of the second renal artery with the second branch sensing element.

3. The method according to claim 1, further comprising:

advancing a catheter shaft of a second bifurcated renal catheter system into an inferior vena cava of the patient;

deploying a first catheter branch of the second bifurcated renal catheter system into a first renal vein of the patient, and a second catheter branch of the second bifurcated renal catheter system into a second renal vein of the patient;

detecting a physiological parameter of the first renal vein, and optionally detecting a physiological parameter of the second renal vein, with a sensing mechanism of the second bifurcated renal catheter system; and

assessing the physiological profile of the patient based on the physiological parameter of the first renal vein, on the physiological parameter of the second renal vein, or on the physiological parameter of the first renal vein and the physiological parameter of the second renal vein.

4. The method according to claim 1, further comprising:

delivering a first amount of a first pharmacological agent to the first renal artery, and optionally delivering a second amount of a second pharmacological agent to the second renal artery, with an agent delivery mechanism of the bifurcated renal catheter system;

detecting a subsequent physiological parameter of the first renal artery, and optionally detecting a subsequent physiological parameter of the second renal artery, with the sensing mechanism of the bifurcated renal catheter system; and

assessing an effect of the first amount of the first pharmacological agent on the physiological profile of the patient based on the subsequent physiological parameter of the first renal artery, and optionally assessing an effect of the of the second amount of the second pharmacological agent on the physiological profile of the patient based on the subsequent physiological parameter of the second renal artery.

5. The method according to claim 6, wherein the first pharmacological agent and the second pharmacological agent each comprise a member selected from the group consisting of a contrast solution, a chemotherapy agent, an antioxidant, sodium bicarbonate, acetylcysteine, a chelation agent, an anti-inflammatory agent, fenoldopam mesylate, a vasodilator, prostaglandin, a diuretic, a loop diuretic, furosemide, an antibiotic agent, a bactericidal agent, a bacteriostatic agent, a neurohormonally active agent, a natriuretic peptide, A-type natriuretic peptide, B-type natriuretic peptide, C-type natriuretic peptide, a synthetic natriuretic peptide, and a bio-engineered natriuretic peptide.

6. The method according to claim 1, further comprising:

performing a surgical procedure on the patient;

detecting a subsequent physiological parameter of the first renal artery, and optionally detecting a subsequent physiological parameter of the second renal artery, with the sensing mechanism of the bifurcated renal catheter system; and

assessing an effect of the surgical procedure on the physiological profile of the patient based on the subsequent physiological parameter of the first renal artery, and optionally assessing the effect of the surgical procedure on the physiological profile of the patient based on the subsequent physiological parameter of the second renal artery.

7. The method according to claim 6, wherein the surgical procedure comprises a member selected from the group consisting of a stenting procedure, a bypass procedure, an angiographic procedure, a percutaneous coronary intervention, and an invasive surgical procedure.

8. The method according to claim 1, wherein the physiological parameter of the first or the second renal artery comprises a blood concentration of a physiological marker selected from the group consisting of aldosterone, renin, angiotensin II, serum creatinine (SrCr), urea, neutrophil gelatinase-associated lipocalin (NGAL), cystanin C, acetylcholine, bradykinin, blood urea nitrogen (BUN), calcium, potassium, sodium, chloride, bicarbonate, oxygen, nitric oxide (NO), nitric oxide synthase (NOS), reactive oxygen species (ROS), iron, an iron-based biochemical derivative, and a blood pH.

9. The method according to claim 1, wherein the physiological parameter of the first or the second renal artery comprises a blood concentration of an inflammatory marker selected from the group consisting of a polymorphonuclear leukocyte (PMN), an interleukin-8 (IL-8), IL-13, and IL-17.

10. The method according to claim 1, wherein the physiological parameter of the first or the second renal artery comprises a blood chemotaxis indicator selected from the group consisting of a chemotaxis protein (MCP), methylesterase, and methyltransferase.

11. The method according to claim 1, wherein the physiological parameter of the first or the second renal artery comprises a blood concentration of a contrast solution.

12. The method according to claim 1, wherein the physiological parameter of the first or the second renal artery comprises a physical marker selected from the group consisting of a renal artery blood flow velocity, a volumetric blood flow rate, a total renal blood flow, an inner arterial wall shear stress, a pressure, a luminal diameter, a stenosis measure, a clot measure, a particle measure, and a temperature.

13. The method according to claim 1, wherein the sensing mechanism comprises a member selected from the group consisting of an ultrasonic transducer sensor, an expandable and retractable frame, a flow guided sensor, a balloon, a mesh umbrella, a flow meter, a shear stress sensor, a pressure sensor, a temperature sensor, a flow velocity sensor, a volumetric flow sensor, a Doppler sensor, and a biochemical sensor.

14. A bifurcated renal catheter system for assessing a physiological profile of a patient, comprising:

a catheter having a shaft coupled with a first catheter branch and a second catheter branch; and

a sensing mechanism having a first sensor coupled with the first catheter branch, and optionally a second sensor coupled with the second catheter branch.

15. The system according to claim 14, wherein the sensing mechanism comprises a member selected from the group consisting of an ultrasonic transducer sensor, an expandable and retractable frame, a flow guided sensor, a balloon, a multi-prong balloon, a mesh umbrella, a flow meter, a shear stress sensor, a pressure sensor, a temperature sensor, a flow velocity sensor, a volumetric flow sensor, a Doppler sensor, a flow rate sensor, a force transducer, a stent, and a biochemical sensor.

16. The system according to claim 14, further comprising a monitoring system coupled with the sensing mechanism.

17. The system according to claim 14, wherein the first catheter branch comprises a first infusion port, and the second catheter branch comprises a second infusion port.

18. The system according to claim 17, further comprising a guide sheath configured to receive the catheter shaft, a system monitor coupled with the sensing mechanism, and an infusion pump coupled with the first and second infusion ports.

19. A method of determining a physiological profile of a patient, comprising:

receiving a physiological parameter of a first renal artery, and optionally receiving a physiological parameter of the second renal artery, at an input module of a monitor and control system, the input module comprising a tangible medium embodying machine-readable code; and

determining the physiological profile of the patient with an assessment module of the monitor and control system, the assessment module comprising a tangible medium embodying machine-readable code.

20. The method according to claim 19, further comprising determining a patient treatment, based on the physiological profile, with a treatment module of the monitor and control system, the treatment module comprising a tangible medium embodying machine-readable code.

21. The method according to claim 20, wherein determining the patient treatment comprises determining a treatment agent and calculating an amount of the treatment agent to be delivered to the first renal artery of the patient.

22. The method according to claim 19, further comprising:

advancing a catheter shaft of a bifurcated renal catheter system into an aorta of the patient;

deploying a first catheter branch of the bifurcated renal catheter system into the first renal artery of the patient, and deploying a second catheter branch of the bifurcated renal catheter system into the second renal artery of the patient;

detecting the physiological parameter of the first renal artery, and optionally detecting the physiological parameter of the second renal artery, with a sensing mechanism of the bifurcated renal catheter system.

23. The method according to claim 19, further comprising administering a treatment to the patient, and determining a subsequent physiological profile of the patient after or while administering the treatment the patient.

24. A bifurcated renal catheter system for assessing a physiological profile of a patient, comprising:

a catheter having a shaft coupled with a first catheter branch and a second catheter branch;

a sensing mechanism having a first sensor coupled with the first catheter branch, and optionally a second sensor coupled with the second catheter branch; and

a monitor and control system comprising an input module having a tangible medium embodying machine-readable code configured to receive an input from the sensing mechanism, and an assessment module having a tangible medium embodying machine-readable code configured to assess the physiological profile of the patient based on the input.

25. A module system for determining a treatment for a patient, comprising:

a catheter having a shaft coupled with a first catheter branch and a second catheter branch;

a sensing mechanism having a first sensor coupled with the first catheter branch, and optionally a second sensor coupled with the second catheter branch; and

a monitor and control system comprising an input module having a tangible medium embodying machine-readable code configured to receive an input from the sensing mechanism, an assessment module having a tangible medium embodying machine-readable code configured to perform an assessment of the physiological profile of the patient based on the input, and a treatment module having a tangible medium embodying machine-readable code configured to determine a patient treatment based on the assessment.