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Publication Number
US-12310621-B2
Publication Date
2025-05-27
Expiration Date
Abstract
An introducer assembly includes an elongate sheath sized for insertion into a blood vessel of a patient and a hub. The hub can be coupled to a proximal portion of the sheath and can include a first hub portion and a second hub portion. The hub can include various features to facilitate breaking apart or separating the introducer assembly from a patient. For example, the first hub portion can have a first notch which can facilitate breaking, splitting, or fracturing the hub. The second hub portion can partially surround the first hub portion and can include two wings and an opening disposed above the first notch. The first hub portion can be formed from a first material and second hub portion can be formed from a second material. In some embodiments, the second material can be stiffer than the first material to facilitate fracturing the hub.
Core Innovation
An introducer assembly is described for percutaneous insertion of a heart pump, including an elongate sheath sized for insertion into a blood vessel and having a longitudinal axis. A hub is coupled to a proximal portion of the elongate sheath and is configured with a multi-material structure to control how the introducer separates during removal.
The hub includes a first hub portion having a first notch and two ridges that define edges of the first notch, with the first ridge and the second ridge extending laterally from the first hub portion. A second hub portion partially surrounds the first hub portion and is over-molded on the first hub portion, the second hub portion comprising two wings and an opening disposed above the first notch.
The first hub portion and the second hub portion use different materials, and the different material properties are used to reduce the break force needed to split or peel away the introducer while minimizing an abrupt release of elastic energy that could jostle or damage the pump. Over-molding is described as optionally forming a hemostatic bond, and additional mechanical interlock features such as ridges and grooves are described to strengthen the bond while an opening disposed above the notch preserves a low break force.
Claims Coverage
The document includes one independent claim (clm-00001). The claim coverage is based on a single inventive framework: a multi-material, over-molded hub on an elongate sheath with notch and wing/opening geometry configured to manage separation behavior during introduction/removal.
Elongate sheath for insertion into a blood vessel with a longitudinal axis
An elongate sheath sized for insertion into a blood vessel of a patient, the elongate sheath having a longitudinal axis.
Multi-feature first hub portion with notch defined by ridges
A hub coupled to a proximal portion of the elongate sheath, the hub comprising a first hub portion having a first notch, a first ridge, and a second ridge, wherein the first ridge and the second ridge define edges of the first notch, and wherein the first ridge and the second ridge extend laterally from the first hub portion.
Over-molded second hub portion partially surrounding the first hub portion
A second hub portion partially surrounding the first hub portion, wherein the second hub portion is over-molded on the first hub portion, and wherein the second hub portion comprises two wings and an opening disposed above the first notch.
Differing first and second materials for the hub portions
Wherein the first hub portion comprises a first material and the second hub portion comprises a second material, the first material differing from the second material.
Across the independent claim, the inventive concept is realized by combining a notched first hub portion with an over-molded, winged second hub portion having an opening disposed above the first notch, where the first and second hub portions comprise differing materials.
Stated Advantages
Reduces the break force needed to split/peel away the introducer.
Minimizes abrupt elastic energy release that could jostle or damage the pump.
Optionally forms a hemostatic bond between hub portions.
Strengthens the bond using ridges/grooves/mechanical interlock features while preserving a low break force through an opening over the notch.
Documented Applications
Percutaneous heart pump insertion using the described introducer assembly having the elongate sheath and multi-layer/multi-material hub.
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