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-11027100-B2

Patent

Publication Date

2021-06-08

Expiration Date


Abstract

An expandable introducer assembly for use in inserting a medical device into a body vessel of a patient includes an expandable sheath subassembly including a sheath hub and an expandable sheath extending from the sheath hub for initial insertion into the body vessel of the patient. The expandable introducer assembly also includes introducer subassembly including a hemostasis valve and an introducer sheath extending from the hemostasis valve and axial advanceable through the sheath hub and into the expandable sheath for radially expanding the body vessel. A coupler is releasably connected to the sheath hub and disposed in interlocked relationship with the hemostasis valve when the hemostasis valve is axially advanced with the introducer sheath towards the sheath hub for allowing serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient.

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 and an expandable sheath arranged in surrounding and coaxial relationship for concurrent insertion and axial advancement into the body vessel. An introducer subassembly includes a hemostasis valve releasably interconnected to a proximal dilator end and an introducer sheath extending from the hemostasis valve in surrounding and coaxial relationship with the dilator toward adjacent the expandable sheath.

A sheath hub of the expandable sheath is interchangeable between a locked condition and an unlocked condition. In the locked condition the sheath hub prevents axial movement of the dilator and the introducer subassembly relative to the expandable sheath during insertion into the body vessel. After insertion, the sheath hub is switched to the unlocked condition to allow concurrent axial advancement of the introducer subassembly and the dilator relative to the expandable sheath, so the introducer sheath passes through the sheath hub and into the expandable sheath for radially expanding the body vessel.

The invention further provides a coupler that is releasably connected to the sheath hub and disposed in an interlocked relationship with the hemostasis valve during axial advancement of the hemostasis valve towards the sheath hub. This interlocked relationship allows serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient.

Claims Coverage

The provided document includes two independent claims (clm-00001 and clm-00015). Together they define an expandable introducer assembly with two main inventive feature clusters: a locked/unlocked sheath hub enabling concurrent advancement and radial expansion, and a coupler interlocked with the hemostasis valve enabling serial retraction.

Interchangeable sheath hub locked and unlocked conditions for preventing and allowing concurrent axial advancement

The expandable sheath includes a sheath hub interchangeable from a locked condition for preventing axial movement of the dilator and the introducer subassembly relative to the expandable sheath during insertion into the body vessel and an unlocked condition for allowing concurrent axial advancement of the introducer subassembly and the dilator relative to the expandable sheath after insertion, to allow the introducer sheath to pass through the sheath hub and into the expandable sheath for radially expanding the body vessel.

Coupler releasably connected to sheath hub and interlocked with hemostasis valve for serial retraction

A coupler releasably connected to the sheath hub and disposed in interlocked relationship with the hemostasis valve when the hemostasis valve is axially advanced towards the sheath hub for allowing serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient.

Expandable sheath subassembly with sheath hub enabling axial advancement through sheath hub for radial expansion

An expandable sheath subassembly including a sheath hub and an expandable sheath extending from the sheath hub for initial insertion into the body vessel; and an introducer subassembly including a hemostasis valve and an introducer sheath extending from the hemostasis valve and axial advanceable through the sheath hub and into the expandable sheath for radially expanding the body vessel.

Coupler interlocked with hemostasis valve during axial advancement toward sheath hub for serial retraction

A coupler releasably connected to the sheath hub and disposed in interlocked relationship with the hemostasis valve when the hemostasis valve is axially advanced with the introducer sheath towards the sheath hub for allowing serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient.

Across both independent claims, the claim coverage centers on a locked and unlocked sheath hub to control axial movement and enable introducer sheath passage into the expandable sheath for radial expansion, and a coupler releasably connected to the sheath hub and interlocked with the hemostasis valve to enable serial retraction of the introducer sheath and expandable sheath out of the body vessel.

Stated Advantages

Allows serial retraction of the introducer sheath and the expandable sheath out of the body vessel of the patient.

Enables radially expanding the body vessel by allowing the introducer sheath to pass through the sheath hub and into the expandable sheath.

Prevents axial movement of the dilator and the introducer subassembly relative to the expandable sheath during insertion into the body vessel.

Allows concurrent axial advancement of the introducer subassembly and the dilator relative to the expandable sheath after insertion into the body vessel.

Documented Applications

Insertion of a medical device into a body vessel of a patient using the expandable introducer assembly.

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