Introducer handle notch design/concept

摘要

An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or introduction of air is described. The introducer assembly is designed with a notch provided at the proximal end of the introducer housing. The notch, which may comprise a multitude of cross-sectional geometries, is designed to reduce the force required to separate the housing and the introducer sheath, thereby minimizing the possibility of unintentional dislodgement during separation. The notch also increases the repeatability and consistency of the amount of force required to separate the introducer housing and sheath.

主权项

1. An introducer, comprising:
a) a sheath comprising a sheath sidewall defining a sheath lumen, the sheath comprising a sheath length extending from a proximal sheath portion having a proximal sheath end to a distal sheath end; b) a housing body comprising a housing sidewall extending along a housing length from a proximal housing portion having a proximal housing end to a distal housing portion having a distal housing end, the housing sidewall defining a housing through-bore extending along a longitudinal axis, wherein the housing sidewall has a thickness spaced from the longitudinal axis, and wherein with the distal housing portion secured to the proximal sheath portion, the housing through-bore provides for passage of a medical device through the housing body and into the sheath lumen; c) at least one stress confining notch that extends through the entire thickness of the housing sidewall from the proximal housing end partway along the housing length to a stress concentration point spaced from the distal housing end; d) a score line having a score line width and a score line length, wherein the score line length extends along a remainder of the housing length of the housing sidewall from the stress concentration point to the distal housing end, wherein the score line width is spaced from and substantially perpendicular to the longitudinal axis, and wherein the notch has a notch width at the proximal housing end that is greater than the score line width; and e) wherein the housing is manipulatable to cause a separation force to be applied to the stress concentration point to thereby separate the housing body and the sheath into two generally equal halved along a first plane aligned with the longitudinal axis.