Dilator and introducer assembly

• US 6,106,540 A
• Filed: 01/13/1999
• Issued: 08/22/2000
• Est. Priority Date: 01/22/1996
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Baxter International Inc.
• Inventors: Yu, Weiyun, White, Geoffrey H.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Goldberg, Jonathan D.
• Application Number:
  US09/117,129
• Time in Patent Office: 587 Days
• Field of Search: 606/190, 606/191, 606/192, 606/185
• US Class Current: 606/191
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A resiliently flexible body vessel or body cavity dilator that tapers toward one end and a transition zone that decreases in flexibility along the dilator away from the one end. The dilator can comprise a dilator arranged to be slid over a guidewire for use in the placement of an intraluminal graft bridging an aortic aneurysm. The dilator can also comprise an inner core of relatively stiff material surrounded by an outer layer of resiliently flexible material.

Claims

1. A resiliently flexible dilator for a bodily vessel, the dilator tapering towards one end to facilitate insertion of the dilator into the vessel and having a transition zone having a first end proximate the said one end and a second end distal the said one end, the physical properties of the dilator in the transition zone being such that the flexibility of the dilator at the second end of the transition zone is less than the flexibility of the dilator at the first end of the transition zone;

wherein the transition zone of the dilator comprises at least one of no more than half the length of the dilator, and no more than one quarter of the length of the dilator;

wherein the flexibility of the transition zone is gradually decreasing between its first and its second end and wherein the flexibility of the dilator apart from the transition zone has a substantially constant flexibility and further comprises an elastomeric material; and

,

wherein the change in flexibility of the transition zone of the dilator is provided by an increase in cross-linking of the elastomeric material comprising the transition zone away from its first end.

2. A resiliently flexible dilator for a bodily vessel, the dilator tapering towards one end to facilitate insertion of the dilator into the vessel and having a transition zone having a first end proximate the said one end and a second end distal the said one end, the physical properties of the dilator in the transition zone being such that the flexibility of the dilator at the second end of the transition zone is less than the flexibility of the dilator at the first end of the transition zone;

wherein the transition zone of the dilator comprises at least one of no more than half the length of the dilator, and no more than one quarter of the length of the dilator;

wherein the flexibility of the transition zone is gradually decreasing between its first and its second end and wherein the flexibility of the dilator apart from the transition zone has a substantially constant flexibility and further comprises an elastomeric material;

wherein the change in flexibility of the transition zone of the dilator is provided by an increase in cross-linking of the elastomeric material comprising the transition zone away from its first end;

wherein the transition zone comprises an inner relatively stiff core of material having a tapering portion with at least the tapering portion being surrounded by a relatively resiliently flexible outer layer that extends beyond the tapering portion of the core material;

wherein the inner core is fabricated from high density polypropylene, and the outer layer is fabricated from an EVA copolymer.

3. A resiliently flexible dilator for a bodily vessel, the dilator tapering towards one end to facilitate insertion of the dilator into the vessel and having a transition zone having a first end proximate the said one end and a second end distal the said one end, the physical properties of the dilator in the transition zone being such that the flexibility of the dilator at the second end of the transition zone is less than the flexibility of the dilator at the first end of the transition zone;

wherein the transition zone of the dilator comprises at least one of no more than half the length of the dilator, and no more than one quarter of the length of the dilator;

wherein the flexibility of the transition zone is gradually decreasing between its first and its second end and wherein the flexibility of the dilator apart from the transition zone has a substantially constant flexibility and further comprises an elastomeric material;

wherein the change in flexibility of the transition zone of the dilator is provided by an increase in cross-linking of the elastomeric material comprising the transition zone away from its first end;

wherein the transition zone comprises an inner relatively stiff core of material having a tapering portion with at least the tapering portion being surrounded by a relatively resiliently flexible outer layer that extends beyond the tapering portion of the core material;

wherein the inner core is fabricated from high-density polypropylene;

the outer layer is fabricated from an EVA copolymer;

wherein the dilator has a longitudinally extending axial bore to receive a guidewire already inserted through the vessel, and has a sheath disposed thereabout so that when the dilator is withdrawn from the vessel the sheath is left in place in the vessel;

wherein the flexibility of the guidewire at said one end and the first end of the transition zone are substantially similar to the flexibility of the guidewire, and;

wherein the flexibility of the second end of the transition zone is substantially similar to the flexibility of the associated sheath.

4. An introducer assembly for introducing a sheath into a bodily vessel comprising a guidewire, a resiliently flexible dilator tapering towards one end of a longitudinally extending axial bore that can receive the guidewire, and a sheath positioned around the dilator, the dilator having a transition zone having a first end proximate the said one end and a second end distal the said one end, the physical properties of the dilator in the transition zone being such that the flexibility of the dilator at the second end of the transition zone is less than the flexibility of the dilator at the at the first end of the transition zone, and;

wherein the one end of the dilator has a flexibility substantially similar to the guidewire.

5. A medical dilator, comprising an elongate shaft that is flexible along its entire length from a proximal end to a distal end, the shaft having a substantially cylindrical outer surface from the proximal end to a tapered portion adjacent the distal end and an axial bore from a proximal end to the distal end, the shaft further including a transition zone having an axial length located adjacent the tapered portion, the transition zone exhibiting a gradual decrease in flexibility along its axial length in the proximal direction, the elongate shaft having a substantially constant flexibility proximal to the transition zone.

6. The dilator of claim 5, wherein the shaft is made of an elastomeric material, and wherein the gradual decrease in flexibility in the transition zone is provided by an increase in cross-linking of the elastomeric material in the proximal direction within the transition zone.

7. The dilator of claim 5, wherein the shaft comprises an inner core having a tapered distal end that terminates at an axial location adjacent the tapered portion of the shaft, and an outer layer surrounding the core along its length and extending beyond the tapered distal end of the core to define the tapered portion of the shaft, the outer layer being relatively more flexible than the inner core, and wherein the gradual decrease in flexibility in the transition zone is provided by the increasing cross-section of the core along its tapered distal end.