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Publication Number
US-11744591-B2
Publication Date
2023-09-05
Expiration Date
Abstract
A medical device for an anastomosis is provided. The medical device distinguishes an inner tubular layer, an outer tubular layer, and a support element defining a longitudinal axis. It further distinguishes two or more independent C-rings distributed and positioned at an acute orientation angle relative to the longitudinal axis of the support element at one end of the support element. The support element and the two or more C-rings are embedded in between the inner and the outer tubular layers. The types of applications one could envision are e.g. a proximal anastomosis, distal anastomosis, or side-to-side anastomoses, in a customized pre-fabricated graft. Embodiments of the invention could also be incorporated into an anastomotic connector device design. Embodiments of the invention could further be envisioned as vascular grafts applications such as Coronary Artery Bypass Graft (CABG), dialysis access grafts and peripheral vascular applications.
Core Innovation
The invention relates to a medical device for an anastomosis that includes an inner tubular layer, an outer tubular layer, and a support element defining a longitudinal axis. The support element and two or more independent C-rings are embedded between the inner and the outer tubular layers.
The device provides two or more independent C-rings distributed and positioned at an acute orientation angle relative to the longitudinal axis of the support element at one end of the support element. The device further includes an end-ring attached to the one end of the support element, aligned substantially in parallel, adjacent, yet independent to the two or more C-rings.
The C-rings can include closed or open C-rings and may have circular or oval geometry. The document also describes a need for improved anastomosis performance, including resistance to kink and toe-flattening and heel-buckling, while enabling radial expansion to fit an aortotomy and create a funnel inlet effect to optimize flow and reduce intimal hyperplasia.
Claims Coverage
The independent claim defines a medical anastomosis device with a layered tubular structure, an embedded support element, and multiple independent C-rings at an acute angle at one end. Dependent claims refine the inventive concept by adding quantified acute-angle ranges, specifying electrospun tubular layers, enumerating support element types, and adding quantified spacing constraints and related structural limitations.
Embedded two-layer tubular structure with embedded support and C-rings
A medical device for an anastomosis comprising an inner tubular layer, an outer tubular layer, a support element defining a longitudinal axis, and two or more independent C-rings distributed and positioned at an acute orientation angle relative to the longitudinal axis of the support element at one end of the support element, wherein the support element and the two or more C-rings are embedded in between the inner and the outer tubular layers.
Independent C-rings at an acute angle at one end
Two or more independent C-rings distributed and positioned at an acute orientation angle relative to the longitudinal axis of the support element at one end of the support element.
End-ring aligned substantially in parallel adjacent yet independent to C-rings
The support element further comprises an end-ring attached to the one end of the support element, wherein the end-ring is aligned substantially in parallel, adjacent, yet independent to the two or more C-rings.
Quantified acute orientation angle range
The medical device is defined such that its acute orientation angle is between 30 degrees and 60 degrees, alternatively such that an acute orientation angle is between 15 degrees and 90 degrees.
Electrospun inner tubular layer
An inner tubular layer that is an electrospun layer.
Support element selected from stent, SRS, coil, wire, or braid
The support element is a stent, an SRS, a coil, a wire, a braid, or another support structure.
Quantified distance between end-ring and first independent C-ring
The distance between the end-ring attached to the support element and the first independent C-ring is within 0.5 to 1.5 mm.
Overall, the claim set covers a layered anastomosis device in which embedded independent C-rings are oriented at an acute angle at one end of an embedded support element, with an end-ring aligned substantially in parallel but independent relative to the C-rings. The dependents further narrow acute angle ranges, require electrospun tubular layers, specify support element types, and impose quantified spacing between the end-ring and the first C-ring.
Stated Advantages
Improved kink resistance, toe-flattening resistance, and heel-buckling resistance.
Axially cuttable C-rings enabling axial slit creation without cutting through the metal.
Radial expansion to fit an aortotomy.
Creation of a funnel inlet effect to optimize flow and reduce intimal hyperplasia.
Documented Applications
Proximal anastomosis.
Distal anastomosis.
Side-to-side anastomosis.
Vascular graft applications including CABG, dialysis access grafts, and peripheral vascular grafts.
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