Method and apparatus for selective drug infusion via an intra-aortic flow diverter delivery catheter

• US 20060030814A1
• Filed: 03/18/2005
• Published: 02/09/2006
• Est. Priority Date: 09/20/2002
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Rosenthal, Michael H., Patel, Samir R., Aboytes, Ricardo, Valencia, Aurelio, Payne, Sam G., Ball, Craig A., Pesotchinsky, Sophia, Elkins, Jeffrey M., Kesten, Randy J., Kramer, Andrew K., Goodson, Harry B., Greenan, Trevor M.
• Application Number:
  US11/083,802
• Publication Number:
  US 20060030814A1
• Time in Patent Office: Days
• US Class Current: 604/93.10
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• 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 local renal delivery system includes a flow isolation assembly and a local injection assembly. The flow isolation assembly in one mode is adapted to isolate only a partial flow region along the outer circumference along the aorta wall such that fluids inject there are maintained to flow substantially into the renal arteries. Various types of flow isolation assemblies and local injection assemblies are described.

Claims

1. A local renal infusion system for treating a renal system in a patient from a location within the abdominal aorta associated with abdominal aortic blood flow into first and second renal arteries via respective first and second renal ostia having unique relative locations along the abdominal aorta wall, comprising:

a local injection assembly;

a flow isolation assembly with a tubular wall having a longitudinal axis between a first end and a second end;

wherein the flow isolation assembly is adapted to be delivered to the location in a first condition with the tubular wall in a first configuration with a first diameter transverse to the longitudinal axis, and such that the first end is located upstream of the renal ostia and the second end is located downstream of the first end;

wherein the flow isolation assembly at the location is adjustable from the first condition to a second condition with the tubular wall in a second configuration;

wherein the tubular wall in the second configuration comprises a second diameter that is greater than the first diameter and that is substantially constant between the first and second ends such that a first region of abdominal aortic flow within an exterior flow path between the wall and the abdominal aortic wall is substantially isolated from a second region of abdominal aortic flow located within an interior flow path within the tubular wall, and further such that the first and second regions of abdominal aortic blood flow are not substantially diverted by the tubular shaped wall; and

wherein the local injection assembly is adapted to be fluidly coupled to a source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first region between the abdominal aortic wall and the tubular wall in the second configuration at the location.

2. The system of claim 1, wherein:

the local injection assembly comprises first and second injection ports;

wherein the first and second injection ports are adapted to be delivered to first and second unique respective positions that are fluidly coupled to the first region at the location;

wherein the first and second injection ports at the first and second positions, respectively, are adapted to be fluidly coupled to the source of fluid agent located externally of the patient; and

wherein the first and second injection ports are adapted to simultaneously inject a volume of fluid agent from the source and principally into the first and second renal arteries, respectively, via their respective renal ostia from the first and second positions, also respectively.

3. The system of claim 2, wherein the first region comprises an outer region of abdominal aortic blood flow generally along the abdominal aorta wall at the location.

4. The system of claim 3, wherein the first and second positions are adapted to inject the volume of fluid agent into first and second separate portions of the abdominal aortic flow within the outer region.

5. The system of claim 3, wherein the first and second positions are located at least 90 degrees apart relative to a circumference around a longitudinal axis of the abdominal aorta at the location.

6. The system of claim 3, wherein the first and second positions are located about 120 degrees apart relative to the circumference.

7. The system of claim 3, wherein the first and second positions are located about 180 degrees apart relative to the circumference.

8. The system of claim 1, further comprising:

a flow isolation assembly;

wherein the flow isolation assembly is adjustable between a first condition and a second condition;

wherein the flow isolation assembly in the first condition is adapted to be delivered to the location;

wherein the flow isolation assembly at the location is adjustable from the first condition to the second condition that is adapted to substantially isolate fluid communication between the first region and a second region of abdominal aortic blood flow;

wherein the local injection assembly in the second configuration is adapted to cooperate with the flow isolation assembly in the second condition so as to inject the volume of fluid agent from the source and into the first region such that the injected volume of fluid agent flows substantially into the first and second renal arteries, respectively, via the respective first and second renal ostia.

9. The system of claim 8, wherein:

the flow isolation assembly comprises a wall that is adjustable between first and second configurations corresponding with the first and second conditions, respectively;

in the first configuration the wall is adapted to be delivered to the location;

in the second configuration the wall is adapted to substantially isolate the first region of abdominal aortic blood flow from the second region of abdominal aortic blood flow.

10. The system of claim 9, wherein:

the wall comprises a tubular wall with a first end, a second end, an outer surface, and an inner surface that defines a longitudinal passageway along a longitudinal axis between the first and second ends;

in the first configuration the longitudinal passageway comprises a first inner diameter;

in the second configuration the longitudinal passageway comprises a second inner diameter that is greater than the first inner diameter;

the first region comprises an exterior flow path around the outer surface between the tubular wall and the abdominal aortic wall; and

the second region comprises an interior flow path within the tubular wall and along the longitudinal passageway.

11. The system of claim 10, wherein:

the flow isolation assembly further comprises a support member that is substantially ring-shaped and is coupled to the tubular wall at one of the first and second ends;

wherein in the first configuration the support member is in a radially collapsed condition with a collapsed diameter transverse to the longitudinal axis of the tubular wall;

wherein in the second configuration the support member is in a radially extended condition with an extended diameter that is greater than the collapsed diameter;

wherein the support member in the radially extended condition supports the tubular wall in an expanded tubular shape at least at the one end.

12. The system of claim 11, wherein:

the support member comprises a superelastic metallic wire with two opposite ends and a curved region between the two opposite ends around a circumferential path;

the wire has a memory shape with the two opposite ends at first and second memory positions relative to each other with respect to the circumferential path such that the curved region has a memory diameter that is less than the extended diameter; and

the wire is secured relative to the tubular member in a superelastically deformed condition with the two opposite ends at first and second displaced positions relative to each other such that the support member in the second configuration and with the extended diameter comprises a superelastically deformed condition for the wire.

13. The system of claim 11, wherein the support member comprises a first support member, the collapsed diameter is a first collapsed diameter, and the extended diameter is a first extended diameter, and further comprising:

a second support member that is substantially ring-shaped and is coupled to the tubular wall at the other of the first and second ends;

wherein in the first configuration the second support member is in a radially collapsed condition with a second collapsed diameter transverse to the longitudinal axis;

wherein in the second configuration the second support member is in a radially extended condition with a second extended diameter that is greater than the second collapsed diameter;

wherein the second support member in the radially extended condition supports the tubular wall in a tubular shape at least at the other end.

14. The system of claim 13, further comprising:

a longitudinal spine extending between the first and second support members.

15. The system of claim 14, wherein:

the local injection assembly comprises an injection port located along the longitudinal spline and oriented so as to inject the volume of fluid agent into the first region.

16. The system of claim 14, wherein:

the local injection assembly comprises first and second injection ports located at first and second respective positions on opposite sides transverse to the longitudinal spine and that are adapted to inject the volume of fluid agent in first and second opposite directions transverse to the longitudinal spine.

17. The system of claim 1, wherein the tubular wall comprises a sheet of polytetrafluoroethylene (PTFE) material that is formed in a substantially tubular shape.

18. The system of claim 10, wherein:

the first end of the tubular wall in the second configuration has a first inner diameter;

the second end of the tubular wall in the second configuration has a second inner diameter; and

the first and second inner diameters are different such that the tubular wall comprises a frustroconical shape.

19. The system of claim 12, wherein the superelastic metallic wire comprises a nickel-titanium alloy.

20. The system of claim 1, wherein the retraction member comprises a wire.

21. The system of claim 1, wherein the retraction member comprises a thread.

22. The system of claim 1, further comprising:

an elongate body with a proximal end portion, a distal end portion that is adapted to be positioned at the location with the proximal end portion extending externally of the patient, a first body passageway, and a second body passageway;

a proximal hub assembly with a housing that comprises a first branch passageway and a second branch passageway;

wherein the first branch passageway is coupled to the first body passageway and is adapted to couple to the source of fluid agent externally of the patient;

wherein the first body passageway is coupled to an injection port and forms at least in part the local injection assembly; and

wherein the second branch passageway is coupled to the second body passageway; and

wherein the proximal end portion of the retraction member extends within the second branch passageway, and the distal end portion of the retraction member extends along the second body passageway.

23. The system of claim 1, wherein the distal end portion of the retraction member is coupled to the second end of the tubular wall.

24. The system of claim 23, further comprising:

an elongate body with a proximal end portion and a distal end portion;

a pulley located along the distal end portion;

wherein the tubular wall is located along the distal end portion with the first end located distally from the second end;

wherein the pulley is located distally adjacent to the first end of the tubular wall;

wherein the distal end portion of the retraction member is adapted to extend across the second end and distally beyond the first end of the tubular wall and loop around the pulley over the first end and proximally along and externally of the tubular wall where it is coupled to the second end; and

wherein the distal end portion of the retraction member is adapted to pull the second end of the tubular wall toward the first end of the tubular wall upon proximal retraction of the proximal end portion of the retraction member externally of the patient.

25. The system of claim 23, further comprising:

an elongate body with a proximal end portion and a distal end portion that is adapted to be positioned at the location while the proximal end portion extends externally of the patient;

a circumferential passageway within the tubular wall at the second end;

a ring-shaped support member located within the circumferential passageway;

wherein the tubular wall is located along the distal end portion with the first end located distally of the second end; and

wherein the distal end portion of the retraction member extends along the distal end portion of the elongate body and externally therefrom adjacent to the second end; and

wherein the distal end portion of the retraction member is coupled to support member through an opening in the circumferential passageway and is adapted to retract the support member distally from the second end.

26. The system of claim 23, further comprising:

an elongate body with a proximal end portion and a distal end portion that is adapted to be positioned at the location while the proximal end portion extends externally of the patient;

wherein the tubular wall is located along the distal end portion with the first end located distally of the second end; and

wherein the distal end portion of the retraction member extends along the distal end portion of the elongate body and externally therefrom proximally adjacent to the second end; and

wherein the distal end portion of the retraction member is adapted to retract the second end proximally from the first end upon proximal retraction of the proximal end portion of the retraction member externally of the patient.

27. The system of claim 1, wherein the expandable member is inflatable.

28. The system of claim 27, wherein the expandable member and inflatable member are inflatable together.

29. The system of claim 1, wherein:

the inflatable member in the inflated condition has a first shape;

the tubular wall in the second configuration has a second shape relative to the longitudinal passageway; and

the at least one flow passageway is formed at gaps between the first shape of the inflatable member and the second shape of the tubular wall.

30. The system of claim 29, wherein a plurality of discrete flow passageways are formed along the longitudinal passageway between the first and second ends with the inflatable member in the inflated condition and the tubular wall in the second configuration.

31. The system of claim 1, wherein:

the wall assembly comprises a tubular member coupled to the plurality of arms and that is constructed of a substantially stretchable material; and

the substantially stretchable material is stretched in the radially extended condition relative to the radially collapsed condition.

32. The system of claim 31, wherein:

the elongate body comprises an outer member that is tubular along the longitudinal axis with a proximal end portion and a distal end portion with a distal tip, and an inner member with a proximal end portion and a distal end portion and a distal tip;

the inner member is located within the outer member;

the inner and outer members are moveable longitudinally relative to each other;

the distal end portion of the inner member extends distally from the distal end portion of the outer member such that the distal tip of the inner member is located distally from the distal tip of the outer member;

the proximal positions for the arms are located along the distal end portion of the outer member;

the distal positions for the arms are located along the distal end portion of the inner member;

in the first condition the distal tips of the outer and inner members have first relative positions relative to each other;

in the second condition the distal tips of the outer and inner members have second relative positions relative to each other and that are longitudinally collapsed relative to the first condition; and

the longitudinal collapse of the distal tips from the first condition to the second condition forces the arms to bias radially outward from the elongate body into the radially extended condition.

33. The system of claim 1, wherein:

the vent comprises an aperture through the wall.

34. The system of claim 1, wherein:

the vent comprises a plurality of apertures through the wall.

35. The system of claim 1, wherein:

the first portion is adapted to be positioned along the location so as to correspond at least in part with the respective locations of the renal ostia; and

the second portion is adapted to be positioned downstream from the renal ostia along the location.

36. The system of claim 35, wherein:

the wall comprises a tubular wall with a first end, a second end, an outer surface, and an inner surface that defines a longitudinal passageway between the first and second ends;

in the first configuration the longitudinal passageway comprises a first inner diameter;

in the second configuration the longitudinal passageway comprises a second inner diameter that is greater than the first inner diameter and is tapered between the first end and the second end;

in the second configuration the first end is located upstream from the renal ostia and the second end is located downstream of the renal ostia;

the first region comprises an exterior flow path around the outer surface between the tubular wall and the abdominal aortic wall;

the second region comprises an interior flow path within the tubular wall and along the longitudinal passageway; and

the second portion with the vent is located adjacent the second end.

37. The system of claim 36, wherein:

the second inner diameter has a reducing taper from the second end to the first end.

38. The system of claim 36, wherein:

the second inner diameter has a reducing taper from the first end to the second end.

39. The system of claim 36, wherein:

the vent comprises a plurality of apertures through the tubular wall and spaced around a circumference around the longitudinal passageway.

40. The system of claim 1, wherein

the wall comprises a tubular wall with an outer surface and an inner surface that defines a longitudinal passageway between the first and second ends;

in the first configuration the longitudinal passageway comprises a first inner diameter;

in the second configuration the longitudinal passageway comprises a second inner diameter that is greater than the first inner diameter and has a reducing taper from the first end to the second end;

the first region comprises an exterior flow path around the outer surface between the tubular wall and the abdominal aortic wall; and

the second region comprises an interior flow path within the tubular wall and along the longitudinal passageway.

41. The system of claim 1, wherein:

the flow isolation assembly comprises a wall that extends between a first end and a second end, a longitudinal spine with a longitudinal axis, and a support member that is substantially ring-shaped along a circumference surrounding the longitudinal axis;

in the first condition the support member is in a radially collapsed condition with a collapsed diameter transverse to the longitudinal axis;

in the second condition the support member is in a radially extended condition with an extended diameter transverse to the longitudinal axis and that is greater than the collapsed diameter;

the first end of the wall is secured at a first location along the longitudinal spine;

the support member is secured to the longitudinal spine at a second location that is spaced from the first location;

the second end of the wall is secured to the support member;

the wall has an arced portion that extends between the first and second locations from only a first portion of the circumference of the support member that is less than the whole circumference of the support member;

in the second condition at the location the first end is located upstream from the renal ostia and the second end is located downstream from the first end;

the first region is located between the wall extending between the support member at the first location and the second location along the longitudinal spine; and

the portion of the outer region of abdominal aortic blood flow that is not included in the first region corresponds with a second portion of the circumference of the support member and from which the wall does not extend toward the second location.

42. The system of claim 41, wherein:

the support member comprises a first support member, the collapsed diameter is a first collapsed diameter, the extended diameter is a first extended diameter;

the flow isolation assembly further comprises a second support member that is substantially ring-shaped along a circumference surrounding the longitudinal axis;

in the first condition the second support member is in a radially collapsed condition with a second collapsed diameter transverse to the longitudinal axis;

in the second condition the second support member is in a radially extended condition with a second extended diameter transverse to the longitudinal axis and that is greater than the second collapsed diameter;

the second support member is secured to the longitudinal spine at the first location;

the first end of the wall is secured to the second support member;

the wall extends between the first and second support members from only a portion of the circumference of the second support member that is less than the whole circumference of the second support member; and

the first region is located between the wall extending between the first and second support members.

43. The system of claim 1, wherein:

the first region comprises first and second portions of the outer region that are spaced from each other around the circumference of the abdominal aortic wall.

44. The system of claim 43, wherein:

the local injection assembly comprises first and second injection members and first and second injection ports located on the first and second injection members, respectively;

the flow isolation assembly comprises first and second walls positioned along the first and second injection members, respectively;

the first and second injection members are adjustable to a radially collapsed orientation relative to each other such that the local injection assembly is adapted to be delivered to the location through a lumen of an introducer sheath;

the first and second injection members at the location are adjustable from the radially collapsed orientation to a radially extended orientation wherein they are spaced transverse to a longitudinal axis by a distance such that the first and second injection ports are adapted to be positioned at first and second unique relative positions within the first and second portions, respectively, within the first region at the location;

the first and second walls in the first condition have first configurations, respectively, that are collapsed relative to the first and second injection members, respectively;

the first and second walls in the second condition have extended configurations, respectively, that are extended with a shape relative to the first and second injection members, respectively;

in the respective extended configurations the first and second walls are adapted to substantially isolate the first and second portions, respectively, of the first region from the second region of the abdominal aorta flow; and

the first and second injection ports at the first and second positions are adapted to be fluidly coupled to the source of fluid agent located externally of the patient and to inject a volume of fluid agent from the source and into the first and second portions, respectively, that are isolated from the second region of abdominal aortic flow by the first and second walls, also respectively.

45. The system of claim 43, wherein:

the flow isolation assembly further comprises first and second support members secured to the first and second injection members, respectively;

each support member is secured to the respective injection member at a first location;

the first and second walls are secured to the first and second support members, respectively;

the first and second support members are adapted to impart the shape to the first and second walls in the respectively extended configurations.

46. The system of claim 43, wherein:

the shape of each wall in the extended configuration comprises a partial funnel shape; and

the first and second injection ports are adapted to be fluidly coupled to a region defined by the partial funnel shape.

47. The system of claim 1, wherein:

the flow isolation assembly comprises a tubular wall with a first end, a second end, and a longitudinal passageway extending between the first and second ends;

the local injection assembly further comprises a passageway within the tubular wall with a common channel fluidly coupled to first and second branch channels;

the first and second injection ports are located along the tubular wall;

the common channel is adapted to be fluidly coupled to the source of fluid agent located externally of the patient when the flow isolation assembly is in the second condition at the location; and

the first and second branch channels are fluidly coupled to the first and second injection ports.

48. The system of claim 47, wherein the first and second injection ports comprises apertures through the tubular wall and into the first and second branch channels, respectively.

49. The system of claim 1, further comprising:

at least one marker coupled to the local injection assembly or the flow isolation and that is adapted to indicate to an operator externally of the patient the location of the local injection assembly or flow isolation assembly, respectively, at the location within the patient.

50. The system of claim 49, wherein the at least one marker comprises a radiopaque marker.

51. 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 local injection assembly at the location within the patient.

52. The system of claim 1, further comprising:

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

53. The system of claim 52, wherein the fluid agent comprises a renal protective agent, diuretic, Furosemide or an analog or derivative thereof, Thiazide or an analog or derivative thereof, a vasopressor, Dopamine or an analog or derivative thereof, a vasodilator, a vasoactive agent, Papaverine or an analog or derivative thereof, a Calcium-channel blocker, Nifedipine or an analog or derivative thereof, Verapamil or an analog or derivative thereof, fenoldapam mesylate or an analog or derivative thereof, or a dopamine DA1 agonist.

54. 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 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 and renal flow assembly are at the location; and

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

55. The system of claim 54, wherein the percutaneous translumenal interventional device comprises an angiographic catheter.

56. The system of claim 54, wherein the percutaneous translumenal interventional device comprises a guiding catheter.

57. The system of claim 54, wherein the percutaneous translumenal interventional device is between about 4 French and about 8 French.

58. The system of claim 1, wherein:

the local injection assembly comprises first and second injection ports;

the flow isolation assembly comprises a spine with a longitudinal axis, a radial support member coupled to the spine at a first location along the longitudinal axis, and an adjustable wall comprising a sheet of substantially flexible material;

wherein the adjustable wall has a first end that is coupled to the radial support member at the first location and a second end that is coupled to the spine at a second location that is spaced along the longitudinal axis from the first location;

wherein the radial support member is adjustable from a first configuration to a second configuration that characterize at least in part the first and second conditions;

in the first configuration the radial support member is radially collapsed relative to the longitudinal axis and positions the adjustable wall in a radially collapsed condition relative to the longitudinal axis, wherein the radial support member and adjustable wall are adapted to be delivered with the spine to the location;

the radial support member at the location is adjustable to the second configuration that is radially extended from the longitudinal axis relative to the first configuration and that at least in part positions the adjustable wall in a radially extended condition that is radially extended from the longitudinal axis relative to the radially collapsed condition;

said adjustable wall in the radially extended condition being positionable along the location relative to the first and second injection ports so as to isolate the injected volume of fluid agent to flow substantially within the first region along the location.

59. The system of claim 58, wherein:

the radial support member comprises a ring-shaped member adjustable between a first shape in the first configuration and a second shape in the second configuration;

the first shape has a first diameter; and

the second shape has a second diameter that is larger than the first diameter and is adapted to radially engage the abdominal aortic wall at an anchoring location along the location within the abdominal aorta so as to anchor the radial support member at the anchoring location.

60. The system of claim 59, wherein the radial support member comprises a ring that is constructed from superelastic material.

61. The system of claim 60, wherein the superelastic material comprises a nickel-titanium alloy.

62. The system of claim 67, wherein:

the ring-shaped member has a circumference; and

the adjustable wall is coupled to the ring-shaped member along only a part of the circumference that is less than all of the circumference of the ring-shaped member.

63. The system of claim 67, wherein:

the part of the circumference of the ring-shaped member in the second shape is adapted to substantially correspond with the first region of the outer region.

64. The system of claim 58, wherein the radial support member comprises a first radial support member, and further comprising:

a second radial support member secured to the spine at the second location;

wherein the second radial support member is adjustable between first and second configurations that together with the first and second configurations for the first radial support member characterize first and second conditions for the flow isolation assembly;

in the first configuration the second radial support member is radially collapsed relative to the longitudinal axis and at least in part positions the adjustable wall to the first condition that is radially collapsed relative to the longitudinal axis, wherein the second radial support member and adjustable wall are adapted to be delivered with the spine to the location;

the second radial support member at the location is adjustable to the second configuration that is radially extended from the longitudinal axis relative to the first configuration and that at least in part positions the adjustable wall in the second condition that is radially extended from the longitudinal axis relative to the first condition.

65. The system of claim 58, wherein:

the adjustable wall in the second condition is adapted to divert an interior region of flow along the abdominal aorta located within the outer region to flow toward the first region; and

the diverted region of abdominal aortic flow is adapted to flow substantially into the first and second renal ostia.

66. The system of claim 58, wherein:

the spine between the first and second locations has a shape in the second configuration that is adapted to position the second location a distance away from the abdominal aorta wall.

67. The system of claim 66, wherein the distance extends beyond the outer region and into an inner region of abdominal aortic blood flow.

68. A proximal coupler assembly for concurrent use with a bilateral local renal delivery device and percutaneous translumenal interventional device, wherein the bilateral local renal delivery device comprises an elongate body with a proximal end portion and a distal end portion and a local injection assembly located along the distal end portion, the assembly comprising:

a housing with a distal end and a proximal end;

wherein the distal end comprises a distal coupler that is adapted to be coupled to an introducer sheath that provides percutaneous translumenal access into a vasculature of a patient that leads to a location within an abdominal aorta associated with renal artery ostia;

wherein the proximal end comprises an adjustable hemostatic coupler;

wherein the adjustable hemostatic coupler is adapted to simultaneously receive the bilateral local renal delivery device and the percutaneous translumenal device into the housing and is substantially aligned along a longitudinal axis with the distal end of the housing;

means for securing the proximal end portion of the bilateral local renal delivery device off-axis relative to the longitudinal axis so as to reduce interference between the percutaneous translumenal interventional device and the bilateral local renal delivery device when the percutaneous translumenal interventional device is manipulated within the hemostatic valve.

69. The assembly of claim 68, further comprising:

means for flushing the housing with a volume of fluid when the bilateral local renal delivery device and percutaneous translumenal interventional device are located within the housing through the adjustable hemostatic coupler.