Sheath for use in peripheral interventions

• US 20050197624A1
• Filed: 03/04/2005
• Published: 09/08/2005
• Est. Priority Date: 03/04/2004
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: FlowMedica, Inc. (AngioDynamics, Inc.)
• Inventors: Goodson, Harry B. IV, Ball, Craig A., Elkins, Jeffrey M.
• Application Number:
  US11/073,421
• Publication Number:
  US 20050197624A1
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A dual lumen introducer sheath provides access to at least one renal artery and at least one peripheral blood vessel of a patient. The introducer sheath includes a proximal hub comprising first and second ports, a first lumen, and a second lumen. The first lumen extends from the first port to a first distal aperture and has sufficient length such that when the first port is positioned outside the patient the first distal aperture is positionable in the abdominal aorta at or near origins of the patient'"'"'s renal arteries. The second lumen extends from the second port to a second distal aperture, has a shorter length than the length of the first lumen, and is configured to allow passage of a catheter device through the second lumen and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient.

Claims

1. A single lumen introducer sheath for accessing at least one renal artery and at least one peripheral blood vessel of a patient, the introducer sheath comprising:

a proximal hub comprising first and second ports;

a lumen extending from the first and second ports and having sufficient length such that when the ports are positioned outside the patient a distal end of the lumen is positionable in an abdominal aorta at or near origins of the patient'"'"'s renal arteries;

a proximal aperture in the lumen, configured to allow passage of a vascular catheter device through the proximal aperture and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient; and

a distal aperture at the distal end of the lumen, configured to allow passage of a bifurcated renal catheter device out of the distal aperture to enter at least one of the renal arteries.

2. An introducer sheath as in claim 1, wherein the proximal aperture comprises a side aperture in the lumen.

3. A dual lumen introducer sheath for accessing at least one renal artery and at least one peripheral blood vessel of a patient, the introducer sheath comprising:

a proximal hub comprising first and second ports;

a first lumen extending from the first port to a first distal aperture and having sufficient length such that when the first port is positioned outside the patient the first distal aperture is positionable in an abdominal aorta at or near origins of the patient'"'"'s renal arteries; and

a second lumen extending from the second port to a second distal aperture and having a shorter length than the length of the first lumen,

wherein the second lumen is configured to allow passage of a catheter device through the second lumen and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient.

4. An introducer sheath as in claim 3, wherein the first and second lumens are disposed side-by-side in a proximal portion of the introducer sheath, and wherein the first lumen extends beyond the proximal portion.

5. An introducer sheath as in claim 3, wherein the first lumen is configured to accept a bifurcated catheter for delivering one or more substances into the renal arteries.

6. An introducer sheath as in claim 3, wherein the second lumen is configured to accept a balloon angioplasty catheter device for performing an angioplasty procedure in one or more peripheral arteries.

7. A method for advancing at least two catheter devices into vasculature of a patient, the method comprising:

positioning a single lumen introducer sheath in the patient such that the sheath extends from a proximal, two-port hub outside the patient into one of the patient'"'"'s iliac arteries, and thus to a distal end in an abdominal aorta at or near origins of renal arteries of the patient;

advancing a bifurcated renal artery catheter device through the distal end of the sheath'"'"'s lumen to extend into the renal arteries; and

advancing a vascular catheter device through a proximal aperture in the lumen into at least one peripheral vessel of the patient on a contralateral side of the patient relative to an insertion point of the sheath.

8. A method as in claim 7, further comprising delivering at least one substance into at least one of the renal arteries through the bifurcated renal artery catheter device.

9. A method as in claim 8, wherein the at least one substance is selected from the group consisting of vasodilators, saline, diuretics, hyper-oxygenated blood, hyper-oxygenated blood substitutes and filtered blood.

10. A method as in claim 8, further comprising delivering at least one additional substance into peripheral vessel(s) of the patient through the vascular catheter device.

11. A method as in claim 10, wherein the additional substance comprises a radiocontrast agent.

12. A method as in claim 10, further comprising performing an interventional procedure in at least one peripheral vessel of the patient, using the vascular catheter device.

13. A method as in claim 12, wherein the interventional procedure comprises an angioplasty procedure.

14. A method for advancing at least two catheter devices into vasculature of a patient, the method comprising:

positioning a dual lumen introducer sheath in the patient such that the sheath extends from a proximal hub outside the patient into one of the patient'"'"'s iliac arteries, and thus to a first distal aperture of a first lumen in an abdominal aorta at or near origins of renal arteries of the patient and to a second distal aperture of a second lumen in or near the iliac artery in which the sheath is positioned;

advancing a bifurcated renal artery catheter device through the first lumen and first distal aperture to extend into the renal arteries; and

advancing a vascular catheter device through the second lumen and second distal aperture into at least one peripheral vessel of the patient on a contralateral side of the patient relative to an insertion point of the sheath.

15. A method as in claim 14, further comprising delivering at least one substance into at least one of the renal arteries through the bifurcated renal artery catheter device.

16. A method as in claim 15, wherein the at least one substance is selected from the group consisting of vasodilators, saline, diuretics, hyper-oxygenated blood, hyper-oxygenated blood substitutes and filtered blood.

17. A method as in claim 15, further comprising delivering at least one additional substance into peripheral vessel(s) of the patient through the vascular catheter device.

18. A method as in claim 17, wherein the additional substance comprises a radiocontrast agent.

19. A method as in claim 17, further comprising performing an interventional procedure in at least one peripheral vessel of the patient, using the vascular catheter device.

20. A method as in claim 19, wherein the interventional procedure comprises an angioplasty procedure.

21. A system for accessing at least one renal artery and at least one peripheral blood vessel of a patient, the system comprising:

a single lumen introducer sheath comprising;

a proximal hub comprising first and second ports;

a lumen extending from the first and second ports and having sufficient length such that when the ports are positioned outside the patient a distal end of the lumen is positionable in an abdominal aorta at or near origins of the patient'"'"'s renal arteries;

a proximal aperture in the lumen, configured to allow passage of a vascular catheter device through the proximal aperture and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient; and

a distal aperture at the distal end of the lumen, configured to allow passage of a bifurcated renal catheter device out of the distal aperture to enter at least one of the renal arteries.

a bifurcated renal artery catheter device for advancing through the first lumen to access the renal arteries; and

a vascular catheter device for advancing through the second lumen and into or through the contralateral iliac artery.

22. A system as in claim 21, wherein the bifurcated renal artery catheter device is configured to expand from a constrained configuration within the introducer sheath to a deployed configuration in which two oppositely directed distal ends are positioned within the two renal arteries or the patient.

23. A system as in claim 22, wherein one of the two distal ends includes an aperture for allowing passage of fluid from the bifurcated renal artery catheter into one of the renal arteries.

24. A system as in claim 22, wherein each of the two distal ends includes an aperture for allowing passage of fluid from the bifurcated renal artery catheter into each of the renal arteries.

25. A system as in claim 21, wherein the vascular catheter device comprises a balloon angioplasty catheter.

26. A system for accessing at least one renal artery and at least one peripheral blood vessel of a patient, the system comprising:

a dual lumen introducer sheath comprising;

a proximal hub comprising first and second ports;

a first lumen extending from the first port to a first distal aperture and having sufficient length such that when the first port is positioned outside the patient the first distal aperture is positionable in the abdominal aorta at or near origins of the patient'"'"'s renal arteries; and

a second lumen extending from the second port to a second distal aperture and having a shorter length than the length of the first lumen,

wherein the second lumen is configured to allow passage of a catheter device through the second lumen and into or through an iliac artery contralateral to an insertion point of the introducer sheath into the patient;

a bifurcated renal artery catheter device for advancing through the first lumen to access the renal arteries; and

a vascular catheter device for advancing through the second lumen and into or through the contralateral iliac artery.

27. A system as in claim 26, wherein the first and second lumens of the sheath are disposed side-by-side in a proximal portion of the introducer sheath, and wherein the first lumen extends beyond the proximal portion.

28. A system as in claim 26, wherein the bifurcated renal artery catheter device is configured to expand from a constrained configuration within the introducer sheath to a deployed configuration in which two oppositely directed distal ends are positioned within the two renal arteries or the patient.

29. A system as in claim 28, wherein one of the two distal ends includes an aperture for allowing passage of fluid from the bifurcated renal artery catheter into one of the renal arteries.

30. A system as in claim 28, wherein each of the two distal ends includes an aperture for allowing passage of fluid from the bifurcated renal artery catheter into each of the renal arteries.

31. A system as in claim 26, wherein the vascular catheter device comprises a balloon angioplasty catheter.