Expandable introducer assembly and method of using same

Inventors

Appling, Anthony • Furnish, Simon • Morris, Ben • Wetzel, Cody • Zeis, Timothy S.

Assignees

Freudenberg Medical LLC

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Publication Number

US-10850071-B2

Patent

Publication Date

2020-12-01

Expiration Date


Abstract

An expandable introducer assembly includes a dilator subassembly extending from a proximal end to a distal end. The dilator subassembly includes a dilator having an insertion portion disposed adjacent the distal end, an expansion portion disposed adjacent the distal end, and a tapered transition portion disposed between the insertion and expansion portions. The dilator subassembly includes a distal sheath disposed in overlaying relationship with the insertion portion of the dilator. An introducer subassembly is disposed in coaxial relationship with the expansion portion of the dilator, and includes a valve disposed adjacent the proximal end and an introducer sheath extending from the valve in overlaying relationship with the expansion portion of the dilator. An expandable sheath subassembly is releasably interlocked with the dilator subassembly and includes an expandable sheath disposed in overlaying relationship with the tapered transition portion and in nested relationship between the insertion portion and the distal sheath.

Core Innovation

The invention relates to an expandable introducer assembly for inserting a medical device into a body vessel of a patient. The assembly includes a dilator subassembly extending from a proximal end to a distal end along an axis, with an insertion portion adjacent the distal end, an expansion portion adjacent the proximal end, and a tapered transition portion disposed between the insertion and expansion portions.

The dilator subassembly includes a distal sheath disposed in overlaying and surrounding relationship with the insertion portion from the distal tapered end of the tapered transition portion to a distal tip adjacent the distal end of the dilator. An introducer subassembly is disposed in surrounding and coaxial relationship with the expansion portion and includes a valve releasably interlocked with the dilator subassembly adjacent the proximal end and an introducer sheath extending from the valve in overlaying relationship with the expansion portion.

An expandable sheath subassembly is releasably interlocked with the dilator subassembly and includes an expandable sheath disposed in overlaying relationship with the tapered transition portion and in a nested relationship between the insertion portion and the distal sheath from the distal tapered end of the tapered transition portion to adjacent the distal tip of the dilator. The document also describes a guide tube and elastomeric seal arrangement in which the guide tube has an outer diameter less than an inner diameter of the elastomeric seal in an open condition to eliminate radial compression forces when the assembly is disposed in the locked condition.

Claims Coverage

The consolidated claim coverage contains five inventive features across the independent claims, centered on a tapered dilator transition, a releasably interlocked introducer subassembly, and a nested expandable sheath subassembly. A further feature adds a guide tube and elastomeric seal dimensional relationship to eliminate radial compression forces in the locked condition.

Tapered dilator transition with insertion portion and expansion portion

A dilator subassembly including a dilator having an insertion portion disposed adjacent the distal end, an expansion portion disposed adjacent the proximal end, and a tapered transition portion disposed between the insertion and expansion portions and tapered outwardly from a distal tapered end adjacent the insertion portion to a proximal tapered end adjacent the expansion portion.

Distal sheath overlaying the dilator insertion portion

A distal sheath disposed in overlaying and surrounding relationship with the insertion portion from the distal tapered end of the tapered transition portion to a distal tip adjacent the distal end of the dilator.

Introducer subassembly with valve and introducer sheath

An introducer subassembly disposed in surrounding and coaxial relationship with the expansion portion and including a valve releasably interlocked with the dilator subassembly adjacent the proximal end and an introducer sheath extending from the valve in overlaying relationship with the expansion portion.

Expandable sheath subassembly nested with the dilator

An expandable sheath subassembly releasably interlocked with the dilator subassembly and including an expandable sheath disposed in overlaying relationship with the tapered transition portion and in a nested relationship between the insertion portion and the distal sheath from the distal tapered end of the tapered transition portion to adjacent the distal tip of the dilator.

Guide tube and elastomeric seal in the locked condition

A guide tube extending along the axis between the dilator hub and the expansion portion, with a valve including an elastomeric seal coaxially aligned with the guide tube when the assembly is disposed in the locked condition, and with the guide tube diameter less than the inner diameter of the elastomeric seal in an open condition to eliminate radial compression forces imposed on the elastomeric seal.

The claim coverage is directed to an expandable introducer assembly in which a tapered dilator transition, a distal sheath, a releasably interlocked valve and introducer sheath, and a nested expandable sheath cooperate during insertion. The additional guide tube and elastomeric seal feature further addresses the locked condition by eliminating radial compression forces.

Stated Advantages

Reduced trauma by reducing shear stress, hoop stress, and axial stress imposed on a vessel.

Tactile feedback.

A smaller insertion profile.

Avoiding pushing past calcification.

Improved re-access outcomes.

Documented Applications

Inserting a medical device into a body vessel of a patient.

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