Enhanced introducer assembly
View Patent ↗Provided is a sheath assembly comprising a dilator hub and sheath hub, configured for coupling by a first movement that combines simultaneous longitudinal and radial movements, followed by a second movement that is substantially radial, and what is also provided is a sheath assembly that comprising a hemostasis valve with a W-slit.
1. A sheath assembly, comprising:
a sheath member comprising:
a sheath tubular member that defines a first longitudinal axis and that has a sheath inner diameter and a sheath outer diameter, and
a sheath hub proximal of the tubular member; and
a tubular member comprising:
a dilator, cannula or catheter that defines a second longitudinal axis and has a first outer diameter,
a dilator hub proximal of the dilator, and
a grip connected to the dilator hub to be grasped by a practitioner,
wherein:
the dilator hub comprises at least one dilator protrusion that extends radially outwards with respect to the second longitudinal axis, and the sheath hub comprises at least one sheath channel, the at least one dilator protrusion and the at least one sheath channel being configured to reversibly and rotatingly couple to one another, wherein the at least one sheath channel extends in a sheath arc having a predetermined number of degrees, the at least one sheath channel being configured to guide the dilator hub to move rotatably in said sheath arc, and to guide the at least one dilator protrusion of the dilator hub to move in a proximal to distal direction along the second longitudinal axis by holding the sheath hub in a stationary position and concurrently rotating the dilator hub, or
the sheath hub comprises at least one sheath protrusion that extends radially inwards with respect to the first longitudinal axis, and the dilator hub comprises at least one dilator channel, the at least one sheath protrusion and at least one dilator channel being configured to reversibly and rotatingly couple to one another, wherein the at least one dilator channel extends in a dilator arc having a predetermined number of degrees, the at least one dilator channel being configured to guide the at least one sheath protrusion of the sheath hub to move rotatably in said dilator arc, and to guide the sheath hub to move in a distal to proximal direction along the first longitudinal axis by holding the dilator hub in a stationary position and concurrently rotating the sheath hub.
2. The sheath assembly of claim 1 , wherein the at least one dilator protrusion or the at least one sheath protrusion comprises at least one ridge, at least one fin, at least one panel, or at least one male thread.
3. The sheath assembly of claim 1 , wherein the at least one dilator protrusion or the at least one sheath protrusion comprises only one ridge, only one fin, only one panel, or only one male thread.
4. The sheath assembly of claim 1 , wherein the sheath member and the tubular member are not coupled to each other when contained by a package.
5. The sheath assembly of claim 1 ,
wherein maximal insertion of the dilator, cannula or catheter into the sheath tubular member is accomplished by transit of the at least one dilator protrusion through the at least one sheath channel by a relative rotation of X degrees between the dilator hub and the sheath hub.
6. The sheath assembly of claim 5 , wherein the transit comprises a sequential first transit and second transit,
wherein an inflection point or central location of an inflection region is between the first transit and the second transit, and
wherein rotation during the first transit is about 0.5 X degrees and rotation during the second transit is about 0.5 X degrees.
7. The sheath assembly of claim 5 , wherein longitudinal movement of the dilator hub towards the sheath hub during the first transit is greater than longitudinal movement of the dilator hub towards the sheath hub during the second transit.
8. The sheath assembly of claim 5 ,
wherein the relative rotation of X degrees to achieve maximal insertion is less than 180 degrees.
9. The sheath assembly of claim 1 , wherein rotational movement of the dilator hub relative to the sheath hub results in longitudinal movement of the dilator hub relative to the sheath hub.
10. The sheath assembly of claim 1 , wherein the sheath hub comprises a hemostasis valve, and wherein the hemostasis valve comprises a W slit.
11. The sheath assembly of claim 1 , wherein:
the sheath tubular member is a peel away sheath comprising a first longitudinal half and a second longitudinal half, the first longitudinal half being separable from the second longitudinal half,
the sheath hub further comprises two opposing tear away wings, one tear-away wing on the side of the first longitudinal half, the other tear-away wing on the side of the second longitudinal half, and
wherein simultaneous application of axial force on the first tear-away wing in opposite vector direction as axial force on the second tear-away wing results in separation of the first longitudinal half from the second longitudinal half.
12. The sheath assembly of claim 1 , wherein the sheath member further comprises a hemostasis valve that has a plurality of holes configured to reduce surface tension when inserting the dilator, cannula or catheter, the hemostasis valve comprising:
an inner seal configured to provide a circumferential seal around the dilator, cannula or catheter,
an outer seal valve configured to seal the sheath member when the dilator, cannula or catheter is not inserted,
a secondary seal configured to pivot up and down,
a middle cavity configured to allow the secondary seal to pivot up and down, as the dilator, cannula or catheter is inserted or retracted, and
a through-hole configured to allow passing of the dilator, cannula or catheter, where the through-hole is defined by the secondary seal.