SELECTIVE RENAL CANNULATION AND INFUSION SYSTEMS AND METHODS

• US 20070287967A1
• Filed: 06/05/2007
• Published: 12/13/2007
• Est. Priority Date: 06/08/2006
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Valencia, Aurelio, Hekmat, Neema, Goodson, Harry, Elkins, Jeffrey
• Granted Patent: US 7,771,401 B2
• Time in Patent Office: Days
• US Class Current: 604/284
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• 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
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

Renal infusion systems include an infusion catheter having a bifurcated distal end with a first branch and second branch, the branches being biased to deploy laterally when unconstrained. Systems also include a delivery sheath having a lumen which receives the infusion catheter and constrains the first branch and second branch. A distal opening of the delivery sheath is formed asymmetrically to allow one of the first and second branches to open laterally while the other of the branches remains constrained. Methods of using renal infusion systems are also provided.

Claims

1. A renal infusion system, comprising:

an infusion catheter having a bifurcated distal end with a first branch and second branch, said branches being biased to deploy laterally when unconstrained; and

a delivery sheath having a lumen which receives the infusion catheter and constrains the first branch and second branch;

wherein a distal opening of the delivery sheath is formed asymmetrically to allow one of the first and second branches to open laterally while the other of the branches remains constrained.

2. A renal infusion system as in claim 1, wherein the distal opening comprises an elongate structure on one side of the sheath and is free from a constraining structure on the other side of the sheath.

3. A renal infusion system as in claim 1, wherein the distal opening is chamfered.

4. A renal infusion system as in claim 1, wherein the asymmetric distal opening has an axial deployment window opposite to a solid wall.

5. A renal infusion system as in claim 4, wherein the delivery sheath has a lateral protrusion proximal and diametrically opposite to the axial deployment window, wherein the protrusion can balance a force caused by deployment of a single branch of the infusion catheter.

6. A renal infusion system as in claim 1, wherein the delivery sheath comprises a detectable marker disposed adjacent the distal opening.

7. A renal infusion system as in claim 1, wherein the delivery sheath comprises a first detectable marker disposed proximally adjacent to the distal opening and a second detectable marker disposed laterally adjacent to the distal opening.

8. A renal infusion system as in claim 7, wherein the first detectable marker is disposed on a first side of the sheath and the second detectable marker is disposed on a second side of the sheath that is opposite to the first side.

9. A renal infusion system as in claim 1, wherein the delivery sheath comprises a semi-circular curve disposed proximal to the distal opening, such that an arc of the semi-circular curve projects in a first direction, and the distal opening faces a second direction opposite to the first direction.

10. A renal infusion system as in claim 1, further comprising an attachment means configured to secure the delivery sheath with a vessel access site of a patient.

11. A method of deploying an infusion catheter in a patient, comprising:

positioning a delivery sheath within an aorta of the patient, the delivery sheath having a distal opening;

advancing a first branch of the infusion catheter through the distal opening of the delivery sheath while preventing advancement of the second branch of the infusion catheter through the distal opening;

advancing the second branch of the infusion catheter through the distal opening of the delivery sheath;

directing the first branch of the infusion catheter toward a first renal artery of the patient; and

directing the second branch of the infusion catheter toward a second renal artery of the patient.

12. A method of deploying an infusion catheter as in claim 11, comprising balancing a force caused by advancement of the first branch with a lateral protrusion of the delivery sheath, wherein the distal opening comprises an axial deployment window, and the lateral protrusion is disposed proximal and diametrically opposite to the axial deployment window.

13. A method of deploying an infusion catheter as in claim 11, further comprising visualizing a position of a distal opening marker relative to the patient.

14. A method of deploying an infusion catheter as in claim 11, further comprising securing the delivery sheath with a vessel access site of the patient with an attachment means.

15. An infusion catheter, comprising:

a catheter body having a distal end with a first branch, said branch being biased to deploy laterally when unconstrained; and

a first valve structure disposed between a main lumen in the catheter body and a branch lumen in the first branch, wherein said first valve structure is closed when the first branch is undeployed and opens in response to lateral deployment of the first branch.

16. An infusion catheter as in claim 15, wherein the distal end is bifurcated and further comprises a second branch that is biased to deploy laterally when unconstrained, the infusion catheter further comprising a second valve structure disposed between the main lumen and a branch lumen in the second branch, wherein said second valve structure is closed when the second branch is undeployed and opens in response to lateral deployment of the second branch.

17. An infusion catheter as in claim 15, wherein the first valve comprises a two-way valve.

18. An infusion catheter as in claim 15, wherein the first valve comprises a pressure-regulated valve that remains closed when a distal side fluid pressure is greater than an aortic blood pressure of the patient.

19. An infusion catheter as in claim 16, wherein the first branch is longer than the second branch.

20. A method of deploying an infusion catheter in a patient, comprising:

advancing a catheter body into an aorta of the patient, the catheter body having a distal end with a first branch, said branch being biased to deploy laterally when unconstrained; and

altering flow volume in a first flow path that passes through the first branch by moving the first branch between a constrained configuration and a laterally deployed configuration.

21. A method of deploying an infusion catheter as in claim 20, wherein moving the first branch toward the laterally deployed configuration comprises moving the first branch toward a first renal artery.

22. A method of deploying an infusion catheter as in claim 20, wherein the catheter body is bifurcated and further comprises a second branch that is biased to deploy laterally when unconstrained, the method further comprising altering flow volume in a second flow path that passes through the second branch by moving the second branch between a constrained configuration and a laterally deployed configuration.

23. A method of deploying an infusion catheter as in claim 22, wherein moving the second branch toward the laterally deployed configuration comprises moving the second branch toward a second renal artery.

24. A method of deploying an infusion catheter as in claim 22, comprising moving the first branch toward the laterally deployed configuration prior to moving the second branch toward the laterally deployed configuration.

25. A method of deploying an infusion catheter as in claim 22, comprising moving the first branch toward the laterally deployed configuration concurrently with moving the second branch toward the laterally deployed configuration.

26. A method of deploying a renal infusion system in a patient having offset real arteries, comprising:

positioning a delivery sheath of the infusion system within an aorta of the patient;

advancing a first catheter branch of the infusion system through a deployment window of the delivery sheath toward a first renal artery;

regulating a first valve to alter a first flow path that passes through the first catheter branch toward the first renal artery;

advancing a second catheter branch of the infusion system through the deployment window of the delivery sheath toward a second renal artery; and

regulating a second valve to alter a second flow path that passes through the second catheter branch toward the second renal artery.

27. The method of claim 26, wherein regulating the first valve comprises adjusting the first branch from a constrained configuration toward a released configuration.

28. The method of claim 27, further comprising restraining the first branch in the constrained configuration with the delivery sheath prior to or subsequent to advancing the first branch through the deployment window.

29. The method of claim 27, wherein adjusting the first branch from a constrained configuration toward a released configuration comprises expanding a fluid lumen of the first branch.

30. The method of claim 26, wherein regulating the first valve occurs concurrently with advancing the first branch through the deployment window.

31. The method of claim 26, wherein regulating the first valve comprises adjusting the first branch from a released configuration toward a constrained configuration.

32. A method of deploying a renal infusion system in a patient, comprising:

positioning a delivery sheath of the infusion system within an aorta of the patient such that a deployment window of the delivery sheath is disposed near a first renal artery and a second renal artery of the patient;

advancing a first catheter branch of the infusion system through the deployment window toward the first renal artery;

regulating a first branch valve to alter a first flow path that passes through the first catheter branch toward the first renal artery; and

retaining a second catheter branch of the infusion system within the delivery sheath.

33. The method of claim 32, further comprising:

advancing the second catheter branch of the infusion system through the deployment window toward the second renal artery; and

regulating a second branch valve to alter a second flow path that passes through the second catheter branch toward the second renal artery.

34. The method of claim 33, wherein advancing the first catheter branch and advancing the second catheter branch occur concurrently.

35. The method of claim 32, further comprising visualizing a position of a deployment window marker relative to the patient.

36. A renal infusion system, comprising:

a delivery sheath configured for placement within an aorta of a patient, the delivery sheath comprising a deployment window;

a first catheter branch configured for advancement through the deployment window of the delivery sheath toward a first renal artery of the patient;

a first flow path that passes through the first catheter branch, the first flow path configured to provide a first fluid flow toward the first renal artery;

a first valve that regulates the first flow path;

a second catheter branch configured for advancement through the deployment window of the delivery sheath toward a second renal artery of the patient;

a second flow path that passes through the second catheter branch, the second flow path configured to provide a second fluid flow toward the second renal artery; and

a second valve that regulates the second flow path.

37. The system of claim 36, wherein the delivery sheath comprises a marker disposed near the deployment window.

38. The system of claim 36, wherein the first branch comprises a constrained configuration and a released configuration, and the first fluid flow through the first flow path is greater when the first branch is in the released configuration than when it is in the constrained configuration.

39. The system of claim 36, wherein the first branch is in a constrained configuration when disposed within the delivery sheath, and is in a released configuration when advanced through the deployment window.

40. The system of claim 36, wherein the first valve comprises a first notch valve that constricts the first flow path when the first branch is in a constrained configuration, and that dilates the first flow path when the first branch is in a released configuration.

41. The system of claim 36, wherein the delivery sheath comprises a semi-circular curve disposed proximal to the deployment window, such that an arc of the semi-circular curve projects in a first direction, and the deployment window faces a second direction opposite to the first direction.

42. The system of claim 36, wherein the first branch comprises a marker.

43. The system of claim 36, wherein the first valve comprises a two-way valve.

44. The system of claim 36, wherein the first valve comprises a pressure-regulated valve that remains closed when a distal side fluid pressure is greater than an aortic blood pressure of the patient.

45. The system of claim 36, further comprising an attachment means configured to secure the delivery sheath with a vessel access site of the patient.

46. The system of claim 36, wherein the first catheter branch is longer than the second catheter branch.