Expandable polymeric flare tip catheter and methods of fabricating same

Patent metadata

Field	Value
Publication number	US-2022395667-A1
Application number	US-202217838626-A
Country	US
Kind code	A1
Filing date	Jun 13, 2022
Priority date	Jun 14, 2021
Publication date	Dec 15, 2022
Grant date	—

Abstract

The designs herein can be for a clot retrieval catheter with a large bore lumen and a distal tip expandable to a diameter larger than that of the guide or sheath through which it is delivered. The designs can have a polymeric flared tip with atraumatic properties and the ability to flexibly expand when ingesting a clot. The tip can have a plurality of axial ribs giving stiffness to certain circumferential regions of the tip for facilitating repeatable collapse when retracted back into the guide or sheath. The tip can also have a metallic support frame within the flared tip for aiding in more gradual compression of clots during aspiration and retrieval with a stentriever. The catheter frame and tip can be sufficiently flexible to navigate highly tortuous areas of the anatomy and recover to maintain the inner diameter of the lumen when displaced in a vessel.

First claim

What is claimed is:

1 . A catheter for administering intravascular treatments, the catheter comprising:
a longitudinal axis; an elongate body comprising a distal end, a lumen, an inner liner, a reinforcing layer, and one or more outer polymeric jackets; and a polymeric flared tip connected to the distal end of the elongate body, the flared tip comprising a collapsed delivery configuration, and an expanded deployed configuration, and a plurality of axial ribs.

2 . The catheter of claim 1 , the axial ribs comprising internal ribs extending radially inward from the inner surface of the flared tip.

3 . The catheter of claim 1 , the axial ribs comprising external ribs extending radially outward from the outer surface of the flared tip.

4 . The catheter of claim 1 , at least a portion of the flared tip having a wall thickness greater than a wall thickness of at least a portion of the elongate body.

5 . The catheter of claim 1 , the ratio of an inner diameter of the elongate body to a maximum inner diameter of the flared tip in the expanded deployed configuration being in a range from approximately 0.55-0.90.

6 . The catheter of claim 1 , the reinforcing layer of the elongate body terminating axially at the proximal end of the flared tip.

7 . The catheter of claim 1 , the flared tip further comprising one or more radial creases configured to facilitate folding of the flared tip from the expanded deployed configuration to the collapsed delivery configuration.

8 . The catheter of claim 1 , the flared tip further comprising one or more longitudinal creases configured to facilitate folding of the flared tip from the expanded deployed configuration to the collapsed delivery configuration.

9 . The catheter of claim 1 , the flared tip further comprising a maximum inner diameter in the expanded deployed configuration larger than that of an outer sheath through which the catheter is delivered.

10 . The catheter of claim 1 , each of the one or more polymeric jackets comprising at least one of Esthane with 5% Carbosil, PU 80A, Pebax, Neusoft, Chronosil, Chronoprene, Chronoflex, Tecothane, or silicone.

11 . The catheter of claim 1 , further comprising a first wall thickness of at least a portion of the flared tip different than a second wall thickness of a different portion of the flared tip.

12 . The catheter of claim 1 , the flared tip further comprising a maximum inner diameter in a range between approximately 0.088 inches and approximately 0.098 inches in the expanded deployed configuration.

13 . The catheter of claim 1 , the flared tip tapering at the distal end to a final inner diameter less than a maximum inner diameter of the tip.

14 . A catheter for removing a clot from a target blood vessel, the catheter comprising:
a longitudinal axis; a substantially tubular elongate body comprising a distal end, a reinforcing layer, and one or more polymer jackets; a metallic support frame connected to the distal end of the elongate body; and a polymeric flared tip and encapsulating the metallic support frame, the flared tip comprising a collapsed delivery configuration, and an expanded deployed configuration, and a plurality of axial ribs.

15 . The catheter of claim 14 , the axial ribs comprising internal ribs extending radially inward from the inner surface of the flared tip.

16 . The catheter of claim 14 , the axial ribs comprising external ribs extending radially outward from the outer surface of the flared tip.

17 . The catheter of claim 14 , the metallic support frame comprising one or more support arms extending distally from the distal end of the elongate body.

18 . A method for manufacturing a catheter, the method comprising:
positioning an inner liner around a substantially tubular core mandrel; positioning a longitudinal polymeric spine around the inner liner; adding a marker band to the distal end of the inner liner; positioning a braided reinforcing layer around the core mandrel, inner liner, polymeric spine, and marker band; reflowing a series of proximal polymeric jackets of varying stiffness to bond the braided reinforcing layer, inner liner, polymeric spine, and marker band as a composite catheter shaft and removing the core mandrel; loading a molding tool proximally into the distal end of the catheter shaft; forming a distal polymeric jacket and the profile of the flared tip using the molding tool; and removing the molding tool from the catheter assembly.

19 . The method of claim 18 , further comprising the step of forming the flared tip through an injection molding process.

20 . The method of claim 18 , further comprising the step of forming the flared tip through a compression molding process.

Assignees

• Neuravi Ltd

Inventors

• Keating Karl
• Kelly Ronald
• Casey Brendan
• Vale David

Classifications

• A61B17/221

  Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)} · CPC title

• A61M25/0045

  multi-layered, e.g. coated (coating materials A61L29/08) · CPC title

• A61M25/0012

  with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils · CPC title

• A61M25/0068 Primary

  Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure · CPC title

• A61B17/22031

  Gripping instruments, e.g. forceps, for removing or smashing calculi (A61B17/221 takes precedence) · CPC title