Apparatus and method for inserting an intra-aorta catheter through a delivery sheath

• US 20050245892A1
• 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., Valencia, Aurelio, Elkins, Jeffrey M., Goodson, Harry B., Maguire, Mark A.
• Granted Patent: US 6,994,700 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

An introducer system delivers therapy locally to a renal system in a patient. A proximal coupler assembly is coupled to an introducer sheath that delivers multiple devices simultaneously into a location within an abdominal aorta associated with first and second renal artery ostia. The coupler assembly has a network of branch lumens arranged to allow for smooth slideable engagement of multiple coupled devices without substantial interference therebetween. A first branch lumen typically introduces a percutaneous translumenal interventional device such as an angiography or guiding catheter into the introducer sheath and is substantially aligned with a longitudinal axis of the sheath. One or more other branch lumen are off-axis from the longitudinal axis by about 30 degrees or less and introduce components of a bilateral renal delivery assembly into the introducer sheath in conjunction with the other device. Novel insertion devices are provided to coordinate the coupling of the multiple devices.

Claims

1. A method for providing a renal therapy system for use in a local renal therapy procedure in a patient comprising:

selecting an introducer sheath based on a length along a catheter that corresponds with a distance between a percutaneous vascular access site and a renal ostium;

wherein the introducer sheath is chosen from a plurality of introducer sheaths having different lengths.

2. The method recited in claim 1, wherein said catheter is an angiographic catheter.

3. The method recited in claim 1, further comprising:

accessing an abdominal aorta in the patient via the percutaneous access site;

inserting the catheter through the percutaneous vascular access site;

positioning a distal end of the catheter at a location within the abdominal aorta associated with a renal artery ostium;

indicating the relative location of the percutaneous vascular access site on said catheter; and

withdrawing said catheter and measuring the length from the percutaneous access point to the distal end of said catheter.

4. The method recited in claim 3, further comprising:

inserting the chosen introducer sheath through the percutaneous vascular access site;

advancing a distal end of the introducer sheath to a position at the location.

5. The method recited in claim 4, further comprising:

advancing a local injection assembly of a bilateral local renal delivery system through an introducer lumen of the introducer sheath and out a distal port of the introducer sheath at the location; and

infusing a fluid agent through the local injection assembly and into the renal artery.

6. The method of claim 5, further comprising:

isolating a first region of abdominal aortic flow at the location from a second region of abdominal aortic flow at the location; and

injecting the volume of fluid agent into the first region.

7. The method of claim 5, further comprising:

delivering first and second injection members with first and second injection ports, respectively, into first and second renal arteries, also respectively, via corresponding first and second renal ostia at the location; and

injection the volume of fluid agent simultaneously through the first and second injection ports into the first and second renal arteries.

8. The method of claim 1, wherein the introducer sheath is selected from a plurality of introducer sheaths having lengths of about 30 cm, 35 cm, 40 cm, and 45 cm.

9. A local renal therapy system, comprising:

an introducer sheath with a tubular wall with a tubular wall with a proximal end portion, a distal end portion that is adapted to be positioned at a location within an abdominal aorta associated with first and second renal ostia of first and second renal arteries, respectively, while the proximal end portion extends externally from the patient, and an introducer lumen that extends along a longitudinal axis between a proximal port along the proximal end portion and a distal port along the distal end portion;

a bilateral renal delivery assembly with a local injection assembly that is adapted to be delivered to the location in a first condition through the introducer lumen;

wherein the introducer sheath has an adjustable length between a first configuration and a second configuration;

wherein in the first configuration the introducer sheath has a first length that is adapted to deliver the local injection assembly in a first condition to the location;

wherein in the second configuration the introducer sheath has a second length that is shorter than the first length and that corresponds with the local injection assembly extending in a second condition distally from the distal port at the location; and

wherein in the second condition at the location the local injection assembly is adapted to be coupled to a source of fluid agent externally of the patient and to deliver a volume of fluid from the source bilaterally into each of the two renal arteries.

10. The system of claim 9, wherein:

the tubular wall has an adjustable section with an accordion shape with a series of undulations along a length;

wherein in the first configuration the accordion shape has a first shape with a first length and a first amplitude of the undulations transverse to the longitudinal axis;

wherein in the second configuration the according shape has a second length that is shorter than the first length and a second amplitude that is greater than the first amplitude.

11. The system of claim 10, further comprising:

an adjustable member that is coupled to the tubular wall and is adjustable between a first position along the tubular wall relative to the adjustable section and a second position along the tubular wall relative to the adjustable section;

wherein the first position corresponds with the first configuration for the introducer sheath and is located to coincide with the adjustable section so as to limit the undulations to the first amplitude and thus expand the adjustable section to the first length;

wherein the second position corresponds with the second configuration for the introducer sheath and is longitudinally removed from the adjustable section; and

wherein the second shape is a memory shape for the adjustable section.

12. The system of claim 11, wherein the adjustable member is located within the introducer lumen.

13. The system of claim 11, wherein the adjustable member is located externally around the tubular wall and is adapted to radially confine the adjustable section to the first shape in the first position.

14. A system for locally delivering therapy to a renal system in a patient, comprising:

an introducer sheath with an elongate tubular body with a proximal end portion, a distal end portion that is adapted to be placed percutaneously into a patient across a vascular access site when the proximal end portion extends externally from the patient, and a delivery lumen extending along a longitudinal axis between a proximal port along the proximal end portion and a distal port along the distal end portion; and

a proximal coupler assembly with a proximal portion and a distal portion;

wherein the distal portion comprises a distal lumen and is coupled to the proximal port with the distal lumen substantially aligned with the longitudinal axis of the delivery lumen;

wherein the proximal portion comprises a first branch lumen and a second branch lumen extending proximally from the distal lumen and terminating proximally at first and second entry ports, respectively;

the first entry port is adapted to receive a percutaneous translumenal interventional device therethrough into the first branch lumen;

the second entry port is adapted to receive a bilateral renal delivery device assembly therethrough and into the second branch lumen; and

wherein the first and second branch lumens are of sufficient orientation relative to the distal lumen, and the first and second branch lumens and distal and delivery lumens are of sufficient dimension, such that each of the percutaneous translumenal interventional device and the bilateral renal delivery device may be slideably engaged simultaneously within the distal lumen and further within the delivery lumen without substantial mutual interference therebetween.

15. The system of claim 14, further comprising:

an insertion device with a tubular wall with a proximal end and a distal end and an insertion lumen extending between a proximal insertion port along the proximal end and a distal insertion port along the distal end, and also having an outer diameter;

wherein the distal portion comprises a distal section and a proximal section;

wherein the distal lumen along the distal section comprises a distal inner diameter;

wherein the distal lumen along the proximal section comprises a proximal inner diameter that is larger than the distal inner diameter;

wherein an inner diameter transition is located between the proximal and distal sections;

wherein the outer diameter of the insertion device is larger than the distal inner diameter but smaller than the proximal inner diameter;

wherein the insertion device is adapted to be inserted through the second entry port through the second branch lumen into the distal lumen along the proximal section, but the transition provides a stop at a position at which the distal end of the tubular member is prevented from advancing distally into the distal lumen along the distal section;

wherein the outer diameter of the tubular wall of the insertion device is sufficient so as to block entry of the percutaneous translumenal interventional device into the distal lumen along the distal section with the distal end of the insertion device is located at the position.

16. The system of claim 15, wherein:

the tubular wall of the insertion device is frangible and comprises a peel-away transducer;

wherein the insertion device at the position is adapted to insert the bilateral renal delivery device into the distal lumen; and

wherein the insertion device is adapted to be withdrawn over the bilateral renal delivery device introduced into the distal lumen and to be peeled therefrom.

17. The system of claim 15, wherein:

the insertion lumen comprises an insertion diameter;

the insertion diameter is sufficient to slideably engage both the bilateral renal delivery device and the percutaneous translumenal delivery device;

with the distal end of the insertion device at the position the tubular wall of the insertion device substantially blocks entry of the percutaneous translumenal interventional device into the distal lumen via the first branch lumen; and

further comprising a needle that is adapted to be inserted into the first branch lumen via the first entry port and to puncture an aperture in the tubular wall; and

wherein the percutaneous translumenal interventional device is adapted to be inserted into the distal lumen through the aperture via the first branch lumen and while the bilateral renal delivery device is co-dwelling within the insertion lumen.

18. The system of claim 14, wherein:

the first branch lumen comprises a first longitudinal axis that is substantially longitudinally aligned with the longitudinal axis of the delivery lumen;

the second branch lumen comprises a second longitudinal axis that is off-axis from the first longitudinal axis by no more than about thirty degrees.

19. The system of claim 18, wherein the second longitudinal axis is off-axis from the first longitudinal axis by about twenty degrees.

20. The system of claim 14, further comprising:

an insertion device with a tubular wall with a proximal end and a distal end and an insertion lumen within an inner diameter extending between a proximal insertion port along the proximal end and a distal insertion port along the distal end, and also having an outer diameter, and also with at least one side-wall aperture through the tubular wall between the proximal and distal ends;

wherein the outer diameter of the insertion device is adapted to be inserted within the distal lumen via the first entry port and first branch lumen such that the side-wall aperture is registered with the second branch lumen; and

wherein the inner diameter is sufficiently large to slideably engage each of the percutaneous translumenal interventional device and the bilateral renal delivery device therethrough; and

wherein the insertion device is adapted to receive the bilateral renal delivery device inserted via the second entry port and second branch lumen through the side-wall aperture registered with the second branch lumen.

21. The system of claim 20, wherein the tubular wall of the insertion device comprises a substantially rigid material.

22. The system of claim 21, wherein the tubular wall of the insertion device comprises a hypotube.

23. The system of claim 14, further comprising:

wherein the first and second branch lumens are of sufficient orientation relative to the distal lumen, and the first and second branch lumens and distal and delivery lumens are of sufficient dimension, such that each of a percutaneous translumenal interventional device of up to about 6 French in size and a bilateral renal delivery device of between about 1 French and about 3 French in size may be slideably engaged simultaneously within the distal lumen and further within the delivery lumen without substantial mutual interference therebetween.

24. The system of claim 14, further comprising:

a delivery catheter that is up to about 6 French in size; and

a bilateral local renal delivery system with an elongate body with a proximal end portion that is between about 1 French and about 3 French is size and distal end portion with a local injection assembly along the distal end portion;

wherein the local injection assembly is adapted to be inserted into the delivery lumen via the distal lumen and second branch lumen through the second entry port;

wherein the delivery catheter is adapted to be delivered into the delivery lumen via the distal lumen and first branch lumen and first entry port; and

wherein the proximal end portion of the elongate body and the delivery catheter are adapted to be simultaneously slideably engaged within the delivery lumen via the first and second branch lumens, respectively, without substantial interference therebetween.

25. The system of claim 24, wherein:

the delivery catheter comprises an angiography catheter.

26. The system of claim 24, wherein:

the delivery catheter comprises a coronary guiding catheter.

27. The system of claim 24, wherein:

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

the first and second delivery members are adapted to be introduced into the delivery lumen via the distal lumen and second side branch lumen in a first configuration positioned in a radially collapsed orientation relative to each other with respect to the longitudinal axis;

the first and second delivery members are adjustable at the location to a second configuration that is advanced distally from the distal port and having positioned in a radially expanded orientation relative to each other with respect to the longitudinal axis; and

wherein the first and second ports are adapted to be delivered to first and second positions that are adapted to inject a volume of fluid agent bilaterally into the first and second renal arteries, respectively.

28. The system of claim 24, wherein:

the bilateral renal delivery assembly further comprises a flow isolation assembly that is adapted to isolate a first region of abdominal aortic flow from a second region of abdominal aortic flow at the location; and

the local delivery assembly is adapted to inject a volume of fluid agent from a source externally of the patient and into the first region.

29. The system of claim 14, further comprising:

a dilator that is adapted to dilate a percutaneous puncture wound to sufficient diameter so as to receive the introducer sheath therethrough.

30. The system of claim 14, further comprising:

first and second adjustable hemostatic valves coupled to the first and second entry ports, respectively.

31. The system of claim 14, wherein the introducer sheath comprises a length between the proximal port and the distal port that is between about 30 cm to about 45 cm long.

32. The system of claim 14, wherein the introducer sheath comprises a size of about 8 French.

43. The system of claim 14, wherein the introducer sheath comprises a size of about 8 French.

33. A system for locally delivering therapy to a renal system in a patient, comprising:

an introducer sheath with an elongate tubular body with a proximal end portion, a distal end portion that is adapted to be placed percutaneously into a patient across a vascular access site when the proximal end portion extends externally from the patient, and a delivery lumen extending along a longitudinal axis between a proximal port along the proximal end portion and a distal port along the distal end portion; and

a proximal coupler assembly with a proximal portion and a distal portion;

wherein the distal portion comprises a distal lumen assembly and is coupled to the proximal port with the distal lumen assembly substantially aligned with the longitudinal axis of the delivery lumen;

wherein the proximal portion comprises a first branch lumen, a second branch lumen, and a third branch lumen coupled to and extending proximally from the distal lumen assembly and terminating proximally at first, second, and third entry ports, respectively;

the first entry port is adapted to receive a percutaneous translumenal interventional device therethrough into the first branch lumen;

the second entry port is adapted to receive a first delivery member of a bilateral renal delivery system therethrough and into the second branch lumen;

the third entry port is adapted to receive a second delivery member of the bilateral renal delivery system therethrough and into the third branch lumen,

wherein the first, second, branch lumens are of sufficient orientation relative to the distal lumen assembly, and the first, second, and third branch lumens, distal lumen assembly, and delivery lumens are of sufficient dimension, such that each of the first and second delivery members of the bilateral renal delivery system and the percutaneous translumenal interventional device may be slideably engaged simultaneously within the distal lumen assembly and further within the delivery lumen without substantial mutual interference therebetween.

34. The system of claim 33, wherein the distal lumen assembly comprises a common delivery lumen coupled to both of the second and third branch lumens.

35. The system of claim 33, wherein:

the first branch lumen has a first longitudinal axis that is substantially aligned with the longitudinal axis of the introducer sheath;

the second branch lumen has a second longitudinal axis that is off-axis relative to the first longitudinal axis by no more than about 30 degrees; and

the third branch lumen has a third longitudinal axis that is off-axis relative to the first longitudinal axis by no more than about 30 degrees.

36. The system of claim 35, wherein the second and third longitudinal axes are off-axis from the first longitudinal axis by no more than about 20 degrees.

37. The system of claim 33, further comprising:

a delivery catheter that is up to about 6 French in size;

a bilateral local renal delivery system with first and second delivery members that have a size that is between about 1 French and about 3 French;

wherein the first and second delivery members are adapted to be introduced into the delivery lumen via the distal lumen assembly and second and third side branch lumens, respectively, in a first configuration positioned in a radially collapsed orientation relative to each other with respect to the longitudinal axis;

the first and second delivery members are adjustable at the location to a second configuration that is advanced distally from the distal port and having positioned in a radially expanded orientation relative to each other with respect to the longitudinal axis; and

wherein the first and second ports are adapted to be delivered to first and second positions that are adapted to inject a volume of fluid agent bilaterally into the first and second renal arteries, respectively.

38. The system of claim 37, wherein the delivery catheter comprises an angiography catheter.

39. The system of claim 37, wherein the delivery catheter comprises a coronary guiding catheter.

40. The system of claim 33, further comprising:

a dilator that is adapted to dilate a percutaneous puncture wound to sufficient diameter so as to receive the introducer sheath therethrough.

41. The system of claim 33, further comprising:

first, second, and third adjustable hemostatic valves coupled to the first, second, and third entry ports, respectively.

42. The system of claim 33, wherein the introducer sheath comprises a length between the proximal port and the distal port that is between about 30 cm to about 45 cm long.