EXPANDABLE INTRA-AORTIC BALLOON PUMP SHEATH

• US 20080183136A1
• Filed: 01/28/2008
• Published: 07/31/2008
• Est. Priority Date: 01/29/2007
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Kick, George F., Nance, Edward J., Lenker, Jay A.
• Granted Patent: US 7,722,568 B2
• Time in Patent Office: Days
• US Class Current: 604/164.03
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Claims

1. An endovascular access sheath system adapted for introducing and removing an intra-aortic balloon pump catheter, comprising:

an axially elongate sheath tube with a proximal end, a distal end, and a central through lumen;

an expandable region of the axially elongate sheath tube, which is enlargeable in circumference in response to outward pressure applied therein,

a hub affixed to the proximal end of the sheath tube, the hub adapted to facilitate the passage of instrumentation and substantially seal against the loss of blood;

an intra-aortic balloon counterpulsation catheter slidably disposed within the endovascular access sheath;

a sheath dilator disposed within the sheath; and

a guidewire lumen within the obturator, capable of passing over standard medical guidewires and which will allow the obturator and sheath to track over said guidewires into an arterial access site, wherein the arterial access site is either a femoral or iliac artery, and be routed to a target location within a thoracic aorta of a patient;

wherein the sheath dilator is capable of enlarging the expandable region of the sheath from a first, collapsed configuration to a second, expanded configuration.

2. The endovascular access sheath of claim 1 wherein the sheath tube comprises:

an outer layer, an inner layer, and a reinforcing layer wherein the outer layer and the inner layer are fabricated from polymeric materials.

3. The endovascular access sheath of claim 1 where the sheath tube comprises a reinforcing layer embedded within a membrane layer fabricated from polymeric materials.

4. The endovascular access sheath of claim 2 wherein the reinforcing layer is a coil of metal.

5. The endovascular access sheath of claim 2 wherein the reinforcing layer is a braid.

6. The endovascular access sheath of claim 2 wherein the inner and outer layer are fabricated from different polymers.

7. The endovascular access sheath of claim 1 wherein the length of the sheath is between about 50 and about 250 cm.

8. The endovascular access sheath of claim 1 wherein the inner lumen of the sheath ranges between about 6 and about 30 French when the distal region is fully expanded.

14. The endovascular access sheath of claim 1 wherein the intra-aortic balloon pump catheter is axially movable but radially constrained within a central lumen of the dilator of the sheath.

15. The endovascular access sheath of claim 1 wherein the intra-aortic balloon pump catheter is integral to the dilator of the sheath.

16. The endovascular access sheath of claim 1 further comprising a lead-in sheath of small diameter, wherein the lead-in sheath resides within the arterial access site during the counterpulsation of the intra-aortic balloon pump.

23. The endovascular access sheath of claim 1 further comprising a lead-in sheath of small diameter and a sterile barrier covering substantially the expandable region of the sheath, wherein the sterile barrier remains outside the patient when the expandable region is advanced into the arterial access site.

24. The endovascular access sheath of claim 23 wherein the sterile barrier is collapsible axially, thus facilitating longitudinal advancement of the endovascular access sheath into the body while maintaining the sterile barrier up to an exterior skin surface of the patient.

9. A method of instrumenting the aorta of a patient for the purpose of introducing and removing an intra-aortic balloon pump catheter comprising the steps of:

routing a guidewire into the aorta from a femoral or iliac artery access point on a patient,

inserting a sheath with a pre-inserted dilator into the patient'"'"'s femoral or iliac artery over the guidewire, and advancing the sheath to a treatment or diagnostic site within the aorta, wherein the sheath comprises a distal expandable region which is collapsed in diameter,

introducing an intra-aortic balloon pump catheter into the aorta of the patient through the sheath,

performing counterpulsation with the intra-aortic balloon pump catheter,

expanding a dilator within the sheath, thus expanding the distal region of the sheath, wherein a full-size lumen exists within at least the distal region of the sheath,

collapsing the dilator by an action applied at the proximal end of said dilator,

withdrawing the dilator from the distal, expandable region of the sheath,

withdrawing the deflated intra-aortic balloon pump catheter into the distal, expandable region of the sheath, and

removing the sheath and intra-aortic balloon pump catheter from the patient.

10. The method of claim 9 wherein the expanding a dilator step is performed by inflating a balloon on the dilator.

11. The method of claim 9 wherein the expanding a dilator step is performed by attaching a liquid-filled inflation device to a balloon inflation port at the distal end of the dilator and infusing liquid under pressure into the dilator.

12. The method of claim 9 wherein the step of collapsing the dilator comprises withdrawing a plunger on the inflation device to withdraw liquid from the dilator.

13. The method of claim 9 wherein the intra aortic balloon catheter is withdrawn completely through the sheath and removed from the proximal end of the sheath prior to the sheath being removed from the patient.

17. The method of claim 9 wherein the full-size lumen created in the expandable region of the sheath by the dilator is substantially larger than a lumen of a proximal non-expandable region of the sheath.

18. The method of claim 9 wherein the full-size lumen created in the expandable region by the dilator is substantially smaller than a lumen of the proximal region of the sheath.

19. The method of claim 9 wherein the full-size lumen created in the expandable region by the dilator is substantially the same size as a lumen of the proximal region of the sheath.

20. A sheath adapted for insertion into the aorta of a mammalian patient comprising:

a means for tracking a sheath over an already placed guidewire to a target treatment site within the aorta of a patient,

a means for introducing an intra-aortic balloon pump through the sheath into an aorta for the purpose of counterpulsation,

a means for dilating at least a portion of the distal end of the sheath, wherein the dilating means is operable from the proximal end of the sheath,

a means for withdrawing the deflated intra-aortic balloon pump within the distal region of the sheath such that a pumping balloon on the intra-aortic balloon pump is isolated from the arterial wall, and

a means for removal of the sheath from the patient.

21. The sheath of claim 20 further comprising means for performing instrumentation, infusion of material into the atria of the aorta, or withdrawal of material from the aorta.

22. The sheath of claim 20 further comprising means for readily visualizing, positioning, and orienting said sheath using visualization techniques employing X-rays.