Method and apparatus for intra-aortic substance delivery to a branch vessel

• US 20050245882A1
• Filed: 03/18/2005
• Published: 11/03/2005
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Patel, Samir R., Aboytes, Ricardo, Valencia, Aurelio, Ball, Craig A., Elkins, Jeffrey M., Goodson, Harry B.
• Granted Patent: US 7,364,566 B2
• Time in Patent Office: Days
• US Class Current: 604/239
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal injection assembly to the location within the abdominal aorta.

Claims

1. A local renal infusion system for treating a renal system in a patient from a location within the abdominal aorta associated with first and second flow paths within an outer region of abdominal aortic blood flow generally along the abdominal aorta wall and into first and second renal arteries, respectively, via their corresponding first and second renal ostia along an abdominal aorta wall in the patient, comprising:

a local injection assembly with first and second injection ports;

wherein the local injection assembly is adapted to be positioned at the location with the first and second injection ports at first and second respective positions, respectively, corresponding with the first and second flow paths;

wherein the local injection assembly is adapted to be fluidly coupled to a source of fluid agent externally of the patient when the local injection assembly is positioned at the location; and

wherein the local injection assembly is adapted to inject a volume of fluid agent from the source, through the first and second injection ports at the first and second positions, respectively, and bi-laterally into the first and second renal arteries, also respectively, via the respective corresponding first and second renal ostia without substantially altering abdominal aorta flow along the location.

2. The system of claim 1, wherein the local injection assembly is adapted to inject the volume of fluid agent into the first and second flow paths such that the injected volume flows substantially only into the first and second renal arteries without substantially diverting one region of aortic blood flow into another region of aortic blood flow.

3. The system of claim 1, wherein the local injection assembly is adapted to inject the volume of fluid agent into the first and second flow paths such that the injected volume flows substantially only into the first and second renal arteries without substantially occluding abdominal aortic blood flow.

4. The system of claim 1, wherein the local injection assembly is adapted to inject the volume of fluid agent into the first and second flow paths such that the injected volume flows substantially only into the first and second renal arteries without substantially isolating the first or second flow paths from adjacent flow paths at the location.

5. The system of claim 1, further comprising:

a delivery member with a proximal end portion and a distal end portion with a longitudinal axis;

wherein the local injection assembly comprises first and second injection members with first and second injection ports, respectively;

wherein the local injection assembly is adapted to extend from the distal end portion of the delivery member and is adjustable between a first configuration and a second configuration;

wherein the local injection assembly in the first configuration is adapted to be delivered by the delivery member to the location; and

wherein the local injection assembly at the location is adjustable from the first configuration to the second configuration such that the first and second first injection members are radially extended from the longitudinal axis with the first and second injection ports located at the first and second positions, respectively, at the first and second flow paths.

6. The system of claim 1, wherein:

the local injection assembly comprises an elongate body that is adapted to be positioned within the outer region; and

the first and second injection ports are spaced at different locations around the circumference of the elongate body such that the first and second injection ports are adapted to inject the volume of fluid agent in first and second different respective directions laterally from the elongate body and generally into the first and second flow paths, respectively.

7. The system of claim 6, further comprising:

a positioner that cooperates with the elongate body and is adapted to position the elongate body within the outer region at the location.

8. The system of claim 7, wherein:

the positioner is coupled to the elongate body and is adjustable from a first configuration to a second configuration;

the positioner in the first configuration is adapted to be delivered to the location with the elongate body; and

the positioner at the location is adapted to be adjusted from the first configuration to the second configuration that is biased to radially extend from the elongate body relative to the first configuration and against the abdominal aorta wall with sufficient force so as to deflect the orientation of the elongate body into the outer region.

9. The system of claim 8, wherein:

the positioner comprises a partial loop-shaped member that extends with first and second legs from the elongate body;

in the first configuration at the location the partial loop-shaped member has a first orientation with respect to the elongate body and is adapted to be delivered to the location; and

in the second configuration at the location the partial loop-shaped member has a second orientation that is radially extended from the elongate body relative to the first orientation.

10. The system of claim 9, wherein:

the partial loop-shaped member has a memory shape;

the partial loop-shaped member is adjusted to the first configuration when subject to deformation force away from the memory shape; and

the partial loop-shaped member is self-adjustable from the first configuration to the second configuration by material recovery of the partial loop-shaped member from the first configuration toward the memory shape.

11. The system of claim 10, wherein

the first and second legs are extendable from the elongate body through first and second extension ports, respectively;

in the first configuration the first and second legs are withdrawn into the elongate body; and

in the second configuration the first and second legs are extended from the elongate body through the first and second extension ports, respectively.

12. The system of claim 9, further comprising:

a control member that is coupled to the partial loop-shaped member and also to the elongate body, and that is adapted to adjust the looped-shape member between the first and second configurations by manipulating the position of the control member.

13. The system of claim 9, wherein the positioner comprises a plurality of said partial loop-shaped members.

14. The system of claim 1, wherein:

the local injection assembly further comprises an elongate body with a longitudinal axis and that is adapted to be positioned at the location;

the first and second injection members in the first configuration have first radial positions relative to the longitudinal axis; and

the first and second injection members in the second configuration have second radial positions that are radially extended from the longitudinal axis relative to the first radial position.

15. The system of claim 14, wherein:

the first and second injection members are located on opposite respective sides of the elongate body around a circumference of the elongate body.

16. The system of claim 15, wherein:

each of the first and second injection members extends between proximal and distal respective locations on each of the opposite respective sides of the elongate body; and

in the second configuration the first and second injection members are biased outward from the elongate body between the respective proximal and distal respective locations.

17. The system of claim 16, wherein:

each of the first and second injection members has a length that is longer than a distance between the respective proximal and distal locations;

each respective proximal location comprises a port;

each of the first and second injection members in the first configuration has a proximal section that extends proximally within the respective port at the respective proximal location and into the elongate body; and

the proximal section of each of the first and second injection members in the second configuration is advanced distally through the port to extend from the elongate body.

18. The system of claim 16, wherein:

each of the first and second injection members adapted to be pressurized with the volume of fluid agent as it is injected through the first and second ports, respectively; and

the first and second injection members are adapted to be adjusted from the first configuration to the second configuration under pressure.

19. The system of claim 16, wherein:

the local injection assembly comprises a generally loop-shaped member;

the first and second injection members comprise first and second regions along the loop-shaped member;

the first and second injection ports are located on each of the first and second regions;

the loop-shaped member in the first configuration has a first diameter between the first and second injection ports such that the loop-shaped member is adapted to be delivered to the location; and

the loop-shaped member in the second configuration has a second diameter between the first and second injection ports that is greater than the first diameter and is sufficient such that the first and second positions generally correspond with first and second flow paths within the outer region, respectively.

20. The system of claim 19, wherein:

the second configuration for the loop-shaped member comprises a memory shape for the local injection assembly;

the loop-shaped member is adjustable from the second configuration to the first configuration within a radially confining outer delivery sheath;

the loop-shaped member is adjustable from the first configuration to the second configuration by removing it from radial confinement outside of the outer delivery sheath.

21. The system of claim 5, wherein:

the local injection assembly comprises a plurality of n injection members, wherein n is an integer that is greater than two;

n injection ports are located on the n injection members, respectively;

each of the n injection members is adapted to be positioned at the location such that the n injection ports are located at n unique respective positions within the outer region;

wherein the local injection assembly is adapted to be oriented at the location such that n minus two of the plurality of injection members are oriented with the corresponding n minus two injection ports against the abdominal aorta wall, and such that the remaining two injection members of the plurality are oriented such that the two corresponding injection ports are at the first and second positions;

wherein the remaining two injection members are the first and second injection members; and

wherein the remaining two injection ports on the two remaining injection members are the first and second injection ports.

22. The system of claim 21, wherein:

each of the plurality of injection ports at its respectively unique position within the outer region is adapted to be fluidly coupled simultaneously with the source of fluid agent externally of the body;

the n minus two injection ports are adapted to be substantially prevented by the abdominal wall from injecting a substantial volume of fluid agent from the source and into the outer region; and

the remaining two injection ports are adapted to inject a substantial volume of fluid agent from the source and into the first and second renal ostia, respectively, such that local injection of fluid agent from the source is substantially isolated to the two injection ports.

23. The system of claim 21, wherein:

in the first configuration at the location the n injection members are positioned at n generally unique radially collapsed positions around a circumference having a first diameter around a longitudinal axis of the abdominal aorta at the location; and

in the second configuration at the location the n injection members are positioned at n generally unique radially expanded positions around a circumference having a second diameter around the longitudinal axis that is greater than the first outer diameter and that is sufficient to position the respective n injection ports at the n respective positions, respectively.

24. The system of claim 21, wherein:

in the first configuration at the location, each of the plurality of local injection members crosses another of the local injection members at an angle relative to a longitudinal axis of the abdominal aorta at the location; and

wherein the angle changes between the first and second configurations, such that the angular adjustment between crossing local injection members allows the local injection assembly to be adjusted from the first configuration corresponding with the first diameter to the second configuration corresponding with the second diameter.

25. The system of claim 5, wherein:

each of the first and second injection members comprises an infusion passageway with an array of n injection regions, wherein n is an integer;

each array of n injection regions is adapted to be coupled to the source of fluid agent outside the body;

the first and second injection members are adapted to be oriented at the location such that x of the n respective injection regions of each array are positioned within the outer region and in fluid communication with the respective renal ostium, and such that y of the respective injection regions of each array are against the abdominal aorta wall such that they are substantially prevented by the abdominal aorta wall from injecting a volume of fluid agent into the outer region; and

wherein the first injection port comprises at least one of the x injection regions along the first injection member; and

wherein the second injection port comprises at least one of the x injection regions along the second injection member; and

wherein x is a positive number that is not greater than n; and

wherein n is equal to x plus y.

26. The system of claim 25, wherein the n injection regions of each array are discretely located along the respective injection member.

27. The system of claim 25, wherein at least two of the n injection regions of each array are continuous with each other along the respective injection member.

28. The system of claim 5, further comprising:

first and second markers located along the first and second injection members, respectively, at locations generally corresponding with the first and second injection ports; and

wherein each of the first and second markers is adapted to indicate to an operator externally of the patient the locations of the first and second injection ports to assist their delivery to the first and second positions, respectively.

29. The system of claim 28, wherein the first and second markers comprise radiopaque markers.

30. The system of claim 28, wherein:

the first and second injection members extend distally from the delivery member from a bifurcation location; and

a proximal marker is located at the bifurcation location.

31. The system of claim 5, wherein:

the delivery member comprises an introducer sheath with a proximal end portion and a distal end portion that is adapted to be positioned at the location with the proximal end portion of the introducer sheath extending externally from the patient, and also with a delivery passageway extending between a proximal port assembly along the proximal end portion of the introducer sheath and a distal port assembly along the distal end portion of the introducer sheath;

the injection assembly is adapted to be slideably engaged within the introducer sheath, and is adjustable between first and second longitudinal positions;

the first and second injection members are located within the delivery passageway in the first longitudinal position; and

the first and second injection members are extended distally through the distal port and from the distal end portion in the second longitudinal position.

32. The system of claim 31, wherein:

the distal end portion comprises a distal tip and a delivery marker at a location corresponding with the distal tip such that the delivery marker is adapted to indicate the relative position of the distal tip within the abdominal aorta at the location.

33. The system of claim 31, wherein:

the distal port assembly comprises a single aperture through which both the first and second injection members extend in adjusting the injection assembly from the first configuration to the second configuration.

34. The system of claim 33, wherein:

the distal port assembly comprises first and second ports;

the first delivery member is extended through the first port when adjusted from the first configuration to the second configuration; and

the second delivery member is extended through the second port when adjusted from the first configuration to the second configuration.

35. The system of claim 34, further comprising:

a catheter body with a proximal end portion and a distal end portion that is adapted to be positioned at the location when the proximal end portion of the catheter body extends externally from the patient;

wherein the first and second injection members are coupled to and extend distally from the distal end portion of the catheter body;

the proximal port assembly of the introducer sheath comprises a single proximal port; and

the first and second injection members and distal end portion of the catheter body are adapted to be inserted into the delivery passageway through the single proximal port.

36. The system of claim 35, further comprising:

a guide sheath that is adapted to introduce the first and second delivery members and distal end portion of the catheter body into the single proximal port.

37. The system of claim 36, wherein the guide sheath is a tear-away sheath.

38. The system of claim 1, further comprising a dilator.

39. The system of claim 1, further comprising:

a proximal coupler assembly that is adapted to be fluidly coupled to a source of fluid agent externally of the patient, and also to the first and second injection ports at the first and second positions, respectively.

40. The system of claim 39, wherein:

the proximal coupler assembly comprises first and second proximal couplers;

the first proximal coupler is fluidly coupled to the first injection port; and

the second proximal coupler is fluidly coupled to the second injection port.

41. The system of claim 40, further comprising:

a first elongate body extending between the first proximal coupler and the first injection member, and with a first fluid passageway coupled to the first proximal coupler and the first injection port; and

a second elongate body extending between the second proximal coupler and the second injection member, and with a second fluid passageway coupled to the second coupler and the second injection port.

42. The system of claim 39, wherein:

the proximal coupler assembly comprises a single common coupler that is fluidly coupled to each of the first and second injection ports via a common fluid passageway.

43. The system of claim 42, further comprising:

an elongate body extending between the single common coupler and the first and second injection members; and

wherein the elongate body has at least one delivery passageway fluidly coupled to the single common coupler and also to the first and second injection ports.

44. The system of claim 1, further comprising:

a source of fluid agent that is adapted to be coupled to the local injection assembly.

45. The system of claim 44, wherein the fluid agent comprises a renal protective agent.

46. The system of claim 44, wherein the fluid agent comprises a diuretic.

47. The system of claim 46, wherein the diuretic comprises Furosemide or an analog or derivative thereof.

48. The system of claim 46, wherein the diuretic comprises Thiazide or an analog or derivative thereof.

49. The system of claim 44, wherein the fluid agent comprises a vasopressor.

50. The system of claim 49, wherein the vasopressor comprises Dopamine or an analog or derivative thereof.

51. The system of claim 44, wherein the fluid agent comprises a vasodilator.

52. The system of claim 44, wherein the fluid agent comprises a vasoactive agent.

53. The system of claim 44, wherein the fluid agent comprises Papaverine or an analog or derivative thereof.

54. The system of claim 44, wherein the fluid agent comprises a Calcium-channel blocker.

55. The system of claim 44, wherein the fluid agent comprises Nifedipine or an analog or derivative thereof.

56. The system of claim 44, wherein the fluid agent comprises Verapamil or an analog or derivative thereof.

57. The system of claim 44, wherein the fluid agent comprises fenoldapam mesylate or an analog or derivative thereof.

58. The system of claim 44, wherein the fluid agent comprises a dopamine DA1 agonist.

59. The system of claim 1, further comprising:

a vascular access system with an elongate tubular body with at least one lumen extending between a proximal port assembly and a distal port that is adapted to be positioned within a vessel having translumenal access to the location;

a percutaneous translumenal interventional device that is adapted to be delivered to an intervention location across the location while the local injection assembly is at the location; and

wherein the local injection assembly and percutaneous translumenal interventional device are adapted to be delivered percutaneously to the location and intervention location, respectively, through the vascular access device, and are also adapted to be simultaneously engaged within the vascular access device.

60. The system of claim 59, wherein the percutaneous translumenal interventional device comprises an angiographic catheter.

61. The system of claim 59, wherein the percutaneous translumenal interventional device comprises a guiding catheter.

62. The system of claim 59, wherein the percutaneous translumenal interventional device is between about 4 French and about 8 French.

63. The system of claim 59, wherein:

the proximal port assembly comprises first and second proximal ports;

the percutaneous translumenal interventional device is adapted to be inserted into the elongate body through the first proximal port; and

the first and second ports of the injection assembly are adapted to be inserted into the elongate body through the second proximal port.

64. The system of claim 1, wherein:

the volume of fluid agent comprises a first volume;

the local injection assembly comprises a fluid reservoir;

the first injection port is fluidly coupled to the fluid reservoir;

the fluid reservoir is adjustable between a first condition, a second condition, and a third condition;

in the first condition the fluid reservoir is adapted to be delivered to the location with the first injection port at the first position at the location;

the fluid reservoir at the location is adapted to be fluidly coupled to a source of fluid agent located externally of the patient;

the fluid reservoir at the location is adjustable from the first condition to the second condition such that the first volume from the source is delivered into the fluid reservoir; and

the local injection assembly at the location is further adjustable from the second condition to the third condition wherein the fluid reservoir discharges the first volume of fluid agent through the injection port at the position; and

wherein the injected first volume of fluid agent is adapted to flow principally into the first flow path.

65. The system of claim 64, wherein:

the reservoir comprises an adjustable wall that forms a chamber;

the first injection port is located on the chamber;

the adjustable wall is adjustable between first and second shapes;

in the first shape the adjustable wall is radially collapsed such that the chamber has a first diameter;

in the second shape the adjustable wall is radially expanded relative to the first shape such that the chamber has a second diameter adapted to house the first volume of fluid agent;

the first shape generally corresponds with the first and third conditions; and

the second shape generally corresponds with the second condition.

66. The system of claim 65, wherein:

the first shape is a memory shape for the adjustable wall;

the adjustable wall is adjusted from the first shape to the second shape by inflation pressure from the first volume of fluid agent injected into the reservoir in the second condition; and

the adjustable wall is self-adjustable from the second shape to the first shape with a memory recovery force upon removal of the inflation pressure; and

the memory recovery force is sufficient to inject the first volume of fluid agent from the reservoir and through the injection port into the first position within the first flow path.

67. The system of claim 65, wherein:

the reservoir comprises a wall that forms at least in part a chamber;

the first injection port is located on the chamber at a first location;

a flow port is located on the chamber at a second location and is fluidly coupled with the first injection port via the chamber;

the flow port is adapted to allow systolic abdominal aortic blood flow to flow into the flow port, through the chamber, and out the first injection port;

the flow port is adapted to substantially prevent diastolic abdominal aortic blood flow from flowing through the chamber;

the fluid reservoir is adjustable from the first condition to the second condition during diastolic abdominal aortic blood flow; and

transition from diastolic to systolic abdominal aortic blood flow adjusts the fluid reservoir from the second condition to the third condition.

68. The system of claim 64, wherein:

the fluid reservoir comprises a first fluid reservoir;

the volume of fluid agent comprises a first volume of fluid agent and a second volume of fluid agent;

the second injection member comprises a second fluid reservoir;

the second fluid reservoir at the location is adapted to be fluidly coupled to a source of fluid agent located externally of the patient;

in the second condition the second volume of fluid agent from the source is delivered into the second fluid reservoir; and

in the third condition wherein the second fluid reservoir discharges the second volume of fluid agent through the injection port at the position.