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Publication Number
US-11298513-B2
Publication Date
2022-04-12
Expiration Date
Abstract
A serration balloon can have a number of different components and can be made in a number of different manners. One or more longitudinally extending members with periodic raised wedges can be attached to a medical balloon. They can be attached with a fiber coating, a polymer coating, or other methods. A polymer matrix can be used to bond the longitudinally extending member to the surface of the balloon. The fiber coating can be, for example, a thread or mesh that secures the longitudinally extending member to the balloon. The medical balloon can be an angioplasty balloon, such as an off-the-shelf angioplasty balloon.
Core Innovation
The invention relates to serration/cutting angioplasty balloons that use an off-the-shelf medical balloon coated with a polymer matrix over-mold. A plurality of longitudinally extending cutting blades is attached to the surface of the polymer-coated medical balloon in the inflated state. Each cutting blade comprises a strip of material with periodic raised wedges spaced along a length thereof.
A first layer of polymer matrix can form an over mold to the medical balloon, and the cutting blades can be attached while the balloon is in the inflated state, including configurations in which blades are retained between polymer layers. Retention of the plurality of cutting blades is described using a retention layer positioned over the cutting blades. Fiber coatings such as thread or mesh can be used for attachment, and polymer matrix over-molding can bond the cutting blade members to the balloon surface.
The cutting blades are described with blade geometry including a flat, planar piece of material with periodic raised wedges, and a primary plane perpendicular to the balloon surface. Controlled balloon expansion effects are described for controlled tearing of plaque, including an energy departure angle of about 45° or less. The disclosure also mentions optional drug and STEM-cell matrix introduction via surface ionic bonding manipulation and optional protective sheath use for insertion.
Claims Coverage
The independent claims explicitly cover three manufacturing methods for a serration balloon: (i) a method that includes over-molding, attaching cutting blades with periodic raised wedges, and retaining the cutting blades with a retention layer; (ii) a method that includes over-molding and attaching cutting blades with periodic raised wedges; and (iii) a method that includes over-molding and attaching a plurality of wedges along the surface while the balloon is inflated. Across these independent claims, the inventive features number at least three distinct process sets: polymer matrix over-molding while inflated, attachment of cutting blades/wedges with periodic raised wedges while inflated, and retention of blades using a retention layer.
Inflated-state polymer matrix over-molding of a medical balloon
Inflating a medical balloon; dipping the medical balloon in the inflated state in a polymer matrix to form an over mold to the medical balloon.
Attaching cutting blades with periodic raised wedges along a polymer-coated balloon surface while inflated
Attaching a plurality of cutting blades along the surface of the polymer coated medical balloon in the inflated state, each cutting blade comprising a strip of material with periodic raised wedges spaced along a length thereof.
Retaining the cutting blades with a retention layer
Retaining the plurality of cutting blades with retention layer over the plurality of cutting blades.
Attaching a plurality of wedges along the surface of the dipped medical balloon while inflated
Dipping the medical balloon in the inflated state in a polymer matrix to form an over mold to the medical balloon and attaching a plurality of wedges along the surface of the dipped medical balloon in the inflated state.
Claim coverage centers on manufacturing serration balloons by inflating a medical balloon, forming a polymer matrix over mold while inflated, attaching cutting blades or wedges with periodic raised wedges along the balloon surface while inflated, and (in one independent claim) retaining the cutting blades using a retention layer.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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