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Publication Number
US-11730943-B2
Publication Date
2023-08-22
Expiration Date
Abstract
Aspects herein relate to a low-friction septum for providing a leak-resistant seal for use in a vascular access device. In an embodiment, a device for vascular access hemostasis is included having an enclosure defining a cavity and configured to at least partially receive a medical device. The device can include a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The device can include a barrel in structural communication with the second seal portion, the second seal portion including a septum seal. The second seal portion can define two or more discrete portions, each separated by one or more split lines. The discrete portions can include a mating surface to interface with mating surfaces of other discrete portions. The mating surface can include a surface topology including raised portions and depressions. Other embodiments are also included herein.
Core Innovation
A low-friction device for vascular access hemostasis includes an enclosure configured to at least partially receive a medical device. The enclosure defines a cavity with a first seal portion and a second seal portion, and the second seal portion comprises a septum seal with a barrel in structural communication with the second seal portion.
The second seal portion defines three or more discrete portions separated by one or more split lines or a split along a split plane. Each discrete portion includes a mating surface configured to interface with mating surfaces of other discrete portions, and the mating surfaces include a surface topology comprising a plurality of raised portions and depressions, including peaks and valleys, intended to reduce contact area and insertion force.
The split septum architecture is complemented by compressive interfacing with a housing, such that the second seal portion can be held in compression to maintain alignment. Structural support features include support ribs configured for compressive interfacing with a housing, with ribs optionally offset from the split and/or substantially symmetrical about the split. Hydrophilic coatings are described as being applied to seal regions and/or mating surfaces to provide lubricious properties.
Claims Coverage
The document includes three independent claims covering a device for vascular access hemostasis with a split septum seal and raised/depressed mating topology, a sealing device with a compressively interfaced enclosure and split-plane discrete mating portions having raised/depressed topology, and a method for making such a sealing device. Across the independent claims, the inventive features emphasize the split second seal into three or more discrete portions with mating surfaces having a raised-portion/depression topology, and compressive interfacing/support relationships with a housing and barrel.
Vascular enclosure with first seal portion and split septum seal discrete portions
An enclosure configured to at least partially receive a medical device, defining a cavity between a first seal portion and a second seal portion that comprises a septum seal, with a barrel in structural communication with the second seal portion; the second seal portion defining three or more discrete portions separated by one or more split lines, the discrete portions each comprising a mating surface including a surface topology with a plurality of raised portions and depressions.
Compressively interfacing enclosure with split-plane discrete mating portions
A device enclosure defining a cavity configured to compressively interface with a housing, including a first seal portion defining an opening and a second seal portion; the second seal portion defining three or more discrete portions separated from one another by a split along a split plane, where the discrete portions each comprise a mating surface to interface with mating surfaces of other discrete portions, the mating surface comprising a surface topology including a plurality of raised portions and depressions.
Forming a split creating discrete mating portions with raised/depressed topology
Obtaining an enclosure configured to at least partially receive a medical device, the enclosure defining a cavity between a first seal portion and a second septum seal portion; forming a split in the second septum seal portion defining three or more discrete portions, each discrete portion comprising a mating surface to interface with mating surfaces of other discrete portions, where the mating surface includes a surface topology having a plurality of raised portions and depressions.
The claim set protects a sealing and hemostasis architecture in which a septum-like second seal portion is divided into three or more discrete portions by split lines or a split plane, and the discrete portions interface via mating surfaces that include raised portions and depressions. Additional claim coverage further specifies compressive interfacing and support structure, as well as hydrophilic layering on seal regions and mating surfaces.
Stated Advantages
Low-friction vascular hemostasis sealing via reduced contact area and reduced insertion force.
Leak-resistant sealing in the low-friction vascular hemostasis sealing device.
Lubricious properties provided by hydrophilic coatings on seal regions and/or mating surfaces.
Documented Applications
Vascular access hemostasis for a medical device, using a low-friction septum seal and sealing device enclosure.
Sealing device use that involves a medical device received by an enclosure defining a cavity bounded by a first seal portion and a second septum seal portion.
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