IP Library › Granted Patent US 12691255
Granted Patent B2
US 12691255 · App. 18/225,810 · Granted Jul 28, 2026

Medical introducer and sheath

Inventors: Georgios T. Hilas (Bloomington, IN); Quentin T. Hillen (Elletsville, IN)
Assignee: Cook Medical Technologies LLC
A61M25/0108
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Quick Facts
Patent No.
US 12691255
App. No.
18/225,810
Granted
Jul 28, 2026
Kind
B2
Abstract

A medical introducer includes a dilator received in an introducer sheath that includes a composite tube extending between a valve and a tip. The composite tube includes a braid with a hollow cylindrical shape sandwiched between an inner polymer tube and outer thermoplastic tube. The tip includes a loaded thermoplastic radiopaque marker, and a crosslinked polymer sleeve with an outer surface that has a flush transition to an outer surface of the composite tube. The radiopaque marker includes a tapered segment, and the crosslinked polymer sleeve extends distally beyond the polymer tube and serves to reinforce, protect and shape the distal introducer sheath tip.

Claims (36)

1 . An introducer comprising:

a sheath and a dilator having a first configuration in which the dilator is received in the sheath, and a second configuration in which the dilator is out of contact with the sheath;

the sheath including a composite tube extending between a valve and a tip, and the composite tube includes a braid with a hollow cylindrical shape sandwiched between, and in contact with, an inner polymer tube and an outer thermoplastic tube;

the tip including a radiopaque marker, which is a loaded thermoplastic, and a crosslinked polymer sleeve that receives a distal segment of the composite tube and at least partially receives the radiopaque marker, and the crosslinked polymer sleeve being longer than the radiopaque marker along an axis of the composite tube;

an outer surface of the crosslinked polymer sleeve has a flush transition to an outer surface of the composite tube at a proximal end of the crosslinked polymer sleeve, and a distal portion of the crosslinked polymer sleeve extends distally beyond a distal end of the inner polymer tube; and

the radiopaque marker having a tapered segment distal to the flush transition.

2 . The introducer of claim 1 wherein the radiopaque marker abuts a distal end of the braid.

3 . The introducer of claim 1 wherein the radiopaque marker abuts the distal end of the inner polymer tube.

4 . The introducer of claim 1 wherein the tapered segment of the radiopaque marker is in contact with a tapered segment of the crosslinked polymer sleeve.

5 . The introducer of claim 1 wherein the tip has a rest inner diameter that is smaller than an outer diameter of the dilator where the tip contacts the dilator in the first configuration.

6 . The introducer of claim 1 wherein the crosslinked polymer sleeve is opaque.

7 . The introducer of claim 1 wherein a distal end segment of the tip includes exactly one layer, which is a portion of the crosslinked polymer sleeve.

8 . The introducer of claim 1 wherein the radiopaque marker is positioned distally of a distal end of the inner polymer tube;

the radiopaque marker has a tapered segment in contact with the tapered segment of the crosslinked polymer sleeve; and

the radiopaque marker is a tungsten loaded material.

9 . An introducer sheath comprising:

a composite tube extending between a valve and a tip, and the composite tube includes a braid with a hollow cylindrical shape sandwiched between, and in contact with, an inner polymer tube and an outer thermoplastic tube;

the tip including a radiopaque marker, which is a loaded thermoplastic, and a crosslinked polymer sleeve that receives a distal segment of the composite tube and at least partially receives the radiopaque marker, and the crosslinked polymer sleeve being longer than the radiopaque marker along an axis of the composite tube;

an outer surface of the crosslinked polymer sleeve has a flush transition to an outer surface of the composite tube at a proximal end of the crosslinked polymer sleeve, and a distal portion of the crosslinked polymer sleeve extends distally beyond a distal end of the inner polymer tube; and

the radiopaque marker having a tapered segment distal to the flush transition.

10 . The introducer sheath of claim 9 wherein the radiopaque marker is entirely positioned distally of a distal end of the inner polymer tube.

11 . The introducer sheath of claim 10 wherein the radiopaque marker abuts a distal end of the inner polymer tube.

12 . The introducer sheath of claim 11 wherein the radiopaque marker is a tungsten loaded material.

13 . The introducer sheath of claim 9 wherein the tapered segment of the radiopaque marker is in mold contact with an inner surface of a tapered segment of the crosslinked polymer sleeve.

14 . The introducer sheath of claim 13 wherein a distal end segment of the tip includes exactly one layer, which is a portion of the crosslinked polymer sleeve.

15 . The introducer sheath of claim 14 wherein the crosslinked polymer sleeve is opaque.

16 . The introducer sheath of claim 9 wherein the tip has a rest inner diameter that is smaller than an outer diameter of a dilator where the tip contacts the dilator in a first configuration.

17 . The introducer sheath of claim 16 wherein the radiopaque marker is positioned distally of a distal end of the inner polymer tube.

18 . The introducer sheath of claim 17 wherein the tapered segment of the radiopaque marker is in mold contact with an inner surface of a tapered segment of the crosslinked polymer sleeve.

19 . A work-in-progress introducer sheath comprising:

a composite tube extending between a proximal end and a tip, and the composite tube includes a braid with a hollow cylindrical shape sandwiched between, and in contact with, an inner polymer tube and an outer thermoplastic tube;

the tip including a radiopaque marker, which is a loaded thermoplastic, and a crosslinked polymer sleeve that receives a distal segment of the composite tube and at least partially receives the radiopaque marker, and the crosslinked polymer sleeve being longer than the radiopaque marker along an axis of the composite tube;

an outer surface of the crosslinked polymer sleeve has a flush transition to an outer surface of the composite tube at a proximal end, and the radiopaque marker having a tapered segment distal to the flush transition;

a peel away tube covering, and in contact with, a distal segment of the composite tube, the flush transition, and the crosslinked polymer sleeve; and

a distal portion of the crosslinked polymer sleeve extends distally beyond a distal end of the inner polymer tube.

20 . The work-in-progress introducer sheath of claim 19 wherein the tip includes a segment with five layers that includes a portion of the inner polymer tube, a portion of the braid, a portion of the thermoplastic tube, a portion of the crosslinked polymer sleeve and a portion of the peel away tube.