Distal access aspiration guide catheter
Distal access aspiration guide catheter system and methods for delivering implantable devices, catheters, or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens are described. A Distal access aspiration guide catheter having a proximal, medial, and distal possessing high flexibility, high resistance to kinking and a large lumen to wall thickness ratio.
1. A catheter device comprising:
an elongate tubular catheter body having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends,
the elongate tubular catheter body comprising an inner tubular liner of a first liner material in coaxial relationship with an outer tubular cover, a tubular member between the inner tubular liner and the outer tubular cover, and a hydrophilic coating on an outer surface of the outer tubular cover, the tubular member comprising a metal helix defining a helical gap and a polymeric kink resistance member comprising a thermoset polymer positioned within the helical gap of the metal helix, and the catheter body, in the region of the distal end, having an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less.
2. A guide catheter comprising:
an elongate tubular member having a proximal end and a distal end and a passageway defining an inner lumen extending between those ends, the elongate tubular member comprising:
a) a relatively stiff proximal segment, the proximal segment comprising an inner proximal tubular liner comprising a proximal liner material in coaxial relationship with an outer proximal tubular cover comprising a proximal cover material, a metallic braid structure positioned upon the inner proximal tubular liner and covered by the outer proximal tubular cover;
b) a relatively flexible distal segment, the distal segment comprising an inner distal tubular liner comprising a distal liner material in coaxial relationship with an outer distal tubular cover comprising a distal cover material, a distal tubular member between the distal liner material and the distal cover material, the distal tubular member comprising and a metal helix defining a helical gap and a polymeric kink resistance member structure positioned within the helical gap, the elongate tubular member, in the region of the distal end, having an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less; and
c) at least one intermediate segment defining a passageway between the relatively stiff proximal segment and the relatively flexible distal segment, the at least one intermediate segment providing a transition from the metallic braid structure to the distal tubular member.
3. A catheter device comprising:
a catheter body comprising:
a tubular member having an inner lumen and an outer surface, said tubular member comprising a metal structure having a helical gap and a polymeric material disposed within the helical gap;
an inner liner extending through the lumen of the tubular member and defining an inner lumen of the catheter; and
an outer cover on the outer surface of the tubular member,
wherein the polymeric material disposed within the helical gap is different from the materials of the inner liner and the outer cover, and
wherein a distal region of the catheter body has an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less.
4. The catheter device of claim 3 wherein the distal region of the catheter body has an inner diameter to wall thickness ratio in a range of 16:1 to 24:1.
5. The catheter device of claim 3 wherein the distal region of the catheter body has a lateral flexibility of greater than or equal to 1200 degrees of deflection per pound-force inch.
6. The catheter device of claim 3 wherein the distal region of the catheter body has an Ultimate Tensile Strength of 22 Newtons.
7. The catheter device of claim 3 , wherein the tubular member extends to a distal end of the catheter body.
8. The catheter device according to claim 3 wherein the metal structure comprises nickel titanium alloy.
9. The catheter device according to claim 3 wherein the metal structure comprises nickel titanium alloy ribbon.
10. The catheter device according to claim 3 wherein the metal structure is a metal helix having the helical gap.
11. The catheter device according to claim 10 wherein the helical gap is of continuous width.
12. The catheter device according to claim 10 wherein a dimension of the metal helix and/or width of the helical gap varies.
13. The catheter device according to claim 3 wherein the polymeric material comprises an elastomer.
14. The catheter device according to claim 3 wherein the polymeric material comprises a cast elastomer.
15. The catheter device according to claim 3 wherein the polymeric material comprises a cast polyurethane.
16. The catheter device according to claim 15 wherein the cast polyurethane comprises a thermoset polyurethane adhesive.
17. The catheter device according to claim 3 wherein the inner liner comprises at least one material selected from the group consisting of: fluoropolymers; PTFE; PFA; and FEP.
18. The catheter device according to claim 3 wherein the outer cover comprises at least one material selected from the group consisting of: polyesters and polyolefins.
19. The catheter device according to claim 10 wherein the catheter device has a plurality of regions along its length wherein a dimension of the metal helix and/or a width of the helical gap differ between said regions.
20. The catheter device according to claim 3 wherein the catheter device has a proximal region, a medial region and a distal region.
21. The catheter device according to claim 20 wherein the outer cover on the proximal region comprises polyester having a thickness of about 0.001 inch; the outer cover on the medial region comprises polyester having a thickness of about 0.0005 inch and the outer cover on the distal region comprises polyolefin having a thickness of about 0.0005 inch.
22. The catheter device according to claim 3 further comprising a balloon.
23. The catheter device according to claim 22 wherein the balloon comprises a compliant balloon.
24. The catheter device according to claim 3 wherein the polymeric material disposed within the helical gap is a thermoset polymer.
25. A method for manufacturing a catheter, the method comprising:
forming a catheter body, wherein forming the catheter body comprises:
A) forming or obtaining a metal helix defining a helical gap;
B) disposing polymeric material comprising a thermoset polymer within the helical gap such that the polymeric material and the metal helix, in combination, form a tubular member having an outer surface and a lumen;
C) disposing an inner liner within the lumen of the tubular member; and
D) disposing an outer cover on the outer surface of the tubular member,
wherein a distal region of the catheter body has an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch) or less.
26. The method according to claim 25 wherein disposing the inner liner within the lumen of the tubular member comprises disposing the inner liner on a mandrel and positioning the metal helix on top of the inner liner.
27. The method according to claim 26 wherein the metal helix comprises a nickel titanium alloy and disposing the inner liner within the lumen of the tubular member comprises winding the nickel titanium alloy about the inner liner and then heat setting the nickel titanium alloy.
28. The method according to claim 26 wherein disposing the inner liner within the lumen of the tubular member comprises casting a flowable polymer mixture into the helical gap and solidifying the flowable polymer, thereby forming the tubular member with the inner liner disposed therein.
29. The method according to claim 28 wherein the polymer comprises a polymer adhesive.
30. The method according to claim 29 further comprising applying a release agent or barrier to one or more selected areas of the metal helix to deter or interrupt adhesion of the polymer adhesive to the selected areas of the metal helix.
31. The method according to claim 29 wherein the polymer adhesive causes adhesion between the tubular member and the inner liner.
32. The method according to claim 29 further comprising disposing a quantity of the polymer adhesive between the outer surface of the tubular member and the inner surface of the outer cover to cause adhesion between the tubular member and the outer cover.
33. The method according to claim 25 wherein the outer cover comprises a tube that initially has an inner diameter that is larger than the outer diameter of the tubular member and wherein disposing the outer cover on the outer surface of the tubular member comprises advancing the outer cover over the tubular member and causing the outer cover to contact the outer surface of the tubular member.
34. The method according to claim 33 further comprising heat shrinking the outer cover onto the outer surface of the tubular member.
35. The method according to claim 25 further comprising disposing a radiographic marker on or in the catheter body.
36. The method according to claim 25 further comprising applying a hydrophilic coating to an outer surface of the outer cover.
37. A method for treating or diagnosing a disorder in a human or animal subject, said method comprising:
inserting a catheter into the subject's vasculature, the catheter including:
a tubular member having an inner lumen and an outer surface, said tubular member comprising a metal helix having a helical gap and a polymeric material disposed within the helical gap;
an inner liner extending through the lumen of the tubular member and defining an inner lumen of the catheter; and
an outer cover on the outer surface of the tubular member;
wherein the polymeric material disposed within the helical gap is different from the materials of the inner liner and the outer cover and wherein a distal region of the catheter body has an inner diameter to wall thickness ratio greater than or equal to 16:1 and a kink radius of about 4.42 millimeters (mm)+/−0.203 mm (about 0.174 inch+/−0.008 inch or less);
delivering a substance or device through the lumen of the catheter device; and
using the substance or device to treat or diagnose the disorder.
38. The method according to claim 37 wherein inserting the catheter comprises advancing the catheter device into a blood vessel located within the subject's skull.
39. The method according to claim 38 further comprising selecting the blood vessel into which the catheter device is advanced from the group consisting of: carotid artery, cerebral artery, anterior cerebral artery, middle cerebral artery and posterior cerebral artery.