Occlusion bypassing apparatus with varying flexibility and methods for bypassing an occlusion in a blood vessel
Inventors
Guala, Carlo • Silvestro, Claudio • Morero, Massimo • Scalvini, Giovanni
Assignees
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Publication Number
US-10456557-B2
Publication Date
2019-10-29
Expiration Date
Abstract
An occlusion bypassing apparatus is disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, an inner shaft component disposed within the outer shaft component, and a needle component slidably disposed within the inner shaft component. The inner shaft component includes a body portion and a needle housing, which is distal to the body portion. The needle housing is less flexible than the body portion. In order to smooth the transition between the body portion and the needle housing, the needle housing includes a transition portion that has a variable flexibility along its length that decreases in a distal direction. A curved distal end of the needle component is distally advanced relative to the inner shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.
Core Innovation
The invention relates to an apparatus for bypassing an occlusion in a blood vessel. The apparatus includes an outer shaft component having a side port proximal to a distal end, and an inner shaft component disposed within the outer shaft component. The inner shaft component defines a continuous lumen through which a needle component is configured to be slidably disposed and removable, and has a body portion extending substantially parallel with a longitudinal axis and a needle housing distally extending from a distal end of the body portion.
The needle housing includes a curved distal portion that bends from the longitudinal axis and terminates at the side port. A transition portion is positioned between the body portion of the inner shaft component and the curved distal portion of the needle housing, and has variable flexibility along its length that decreases in a distal direction. The transition portion includes a plurality of apertures configured to provide the transition portion with the variable flexibility, where the apertures include pairs of apertures that align along a transverse axis, and each aperture in each pair has an hourglass shape.
A needle component is configured to have a curved distal end with the same curvature as the curved distal portion of the needle housing. The curved distal end is held in a straightened form within the needle housing and then extends from the side port and bends from the longitudinal axis in a second configuration. The apparatus further provides for a polymeric tube body portion and a needle housing formed from a tube of a shape memory material, with opposing tabs at a proximal end of the needle housing.
Claims Coverage
The document identifies three independent claims. Across these claims, the coverage centers on an outer shaft with a side port and an inner shaft with a curved needle housing, a transition portion with variable flexibility decreasing in a distal direction provided by hourglass-shaped apertures, and a removable needle component having a curved distal end matching the curved needle housing.
Outer shaft with side port and continuous lumen inner shaft
An outer shaft component having a side port proximal to a distal end, and an inner shaft component disposed within the outer shaft component and defining a continuous lumen there-through, the inner shaft component having a body portion extending substantially parallel with a longitudinal axis and a needle housing distally extending from a distal end of the body portion.
Curved distal needle housing terminating at the side port with a transition portion
A needle housing including a curved distal portion that bends from the longitudinal axis and terminates at the side port, and a transition portion positioned between the body portion and the curved distal portion.
Variable flexibility transition portion with paired hourglass-shaped apertures
The transition portion having variable flexibility along a length thereof that decreases in a distal direction, the transition portion including a plurality of apertures configured to provide the transition portion with the variable flexibility, and the plurality of apertures including pairs of apertures that align along a transverse axis, each aperture in each pair having an hourglass shape.
Slidably disposed removable curved needle component matching needle housing curvature
A needle component configured to be slidably disposed within the continuous lumen of the inner shaft component and removable therefrom, the needle component having a curved distal end with the same curvature as the curved distal portion of the needle housing.
Straightened first configuration and deployed second configuration of the curved needle end
In a first configuration the curved distal end of the needle component is held in a straightened form within the needle housing, and in a second configuration the curved distal end extends from the side port and bends from the longitudinal axis.
Polymeric tube body portion, shape memory needle housing tube, and opposing tabs
The body portion of the inner shaft component includes a polymeric tube and the needle housing is formed from a tube of a shape memory material, a proximal end of the needle housing including two opposing tabs attached to the distal end of the body portion.
Outer shaft with at least one balloon, inflation lumen, and guidewire lumen
The outer shaft component having a side port proximal to the distal end and at least one balloon disposed proximal to the distal end, wherein the outer shaft component defines an inflation lumen in fluid communication with the at least one balloon and a guidewire lumen extending at least along a distal portion thereof.
Hourglass aperture bridge/waist longitudinal alignment in the transition portion
The transition portion includes a plurality of apertures each having an hourglass shape with a waist region positioned between a top region and a bottom region, each hourglass-shaped aperture extending around an outer surface of the needle housing with a bridge area defined between the top region and the bottom region, and adjacent hourglass-shaped apertures positioned such that a bridge area of a first hourglass-shaped aperture longitudinally aligns with a waist region of a second hourglass-shaped aperture.
The independent claims collectively cover an occlusion-bypassing apparatus with an outer shaft side port and inner shaft continuous lumen, a distal needle housing with a curved distal portion terminating at the side port, and a transition portion whose variable flexibility decreases distally via hourglass-shaped apertures. The claims also cover a removable, slidably disposed needle component with a curved distal end matching the curved needle housing curvature, including a straightened-to-deployed configuration, and, depending on the independent claim, balloon(s) with an inflation lumen and a guidewire lumen, as well as polymeric and shape-memory tube construction with opposing tabs.
Stated Advantages
Documented Applications
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