Implant
Inventors
Lavrijsen, Tom • Nandakumar, Anandkumar • Cox, Martijn Antonius Johannes • Baaijens, Franciscus Petrus Thomas • Bouten, Carolina Victoria Catharina • Bosman, Anton • MES, Tristan • Dankers, Patricia Yvonne Wilhelmina
Assignees
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Publication Number
US-11452624-B2
Publication Date
2022-09-27
Expiration Date
Abstract
The disclosure lies in the field of regenerative medicine and relates to an implant having a matrix material, and a method for manufacturing an implant having matrix material. The disclosure further relates to a crimped implant.
Core Innovation
The invention provides an implant for regenerating tissue in vivo that comprises at least one support structure and a fibrous network consisting of one or more supramolecular polymer compounds. The fibrous network has at least 60% porosity with pores having a diameter ranging from 1 to 300 micrometers, and exhibits a linear elastic stiffness ranging from 0.1 to 50 MPa.
The implant is described in regenerative-medicine context with a porous fibrous matrix having at least 60% porosity, preferably in a 70–90% range, and pore diameters in a 1–300 micrometer range, preferably 5–100 micrometers. The fibrous matrix is made from electrospun supramolecular polymers, including PCL-based supramolecular backbones such as PCL and caprolactone, as well as poly lactic acid with lactic acid, UPy, bisurea, PCL-bisurea, and PCL-UPy.
Cardiovascular embodiments further include reinforcement structures and crimpable configurations, with circumferential fiber alignment to impart anisotropic mechanical behavior using a stiffness ratio between fiber direction and perpendicular fiber direction. The described manufacturing approach uses electrospinning onto a mold, in which a fibrous network is applied to the mold by electrospinning of the one or more supramolecular compounds and then the implant and mold are separated.
Claims Coverage
The independent claims cover three inventive feature groups: an implant for in vivo tissue regeneration with specific fibrous-network microstructure, a manufacturing method using electrospinning onto a mold with subsequent separation, and an implant variant with circumferential fiber alignment.
In vivo regenerative implant with supramolecular fibrous network properties
An implant for regenerating tissue in vivo comprising at least one support structure and a fibrous network consisting of one or more supramolecular polymer compounds, wherein the fibrous network has at least 60% porosity, pores with a diameter ranging from 1 to 300 micrometers, and a linear elastic stiffness ranging from 0.1 to 50 MPa.
Manufacturing method by electrospinning onto a mold and separating the implant
A method for manufacturing an implant for regenerating tissue in vivo having at least one support structure and a fibrous network consisting of one or more supramolecular polymer compounds, wherein the fibrous network has at least 60% porosity, pores with a diameter ranging from 1 to 300 micrometers, and a linear elastic stiffness ranging from 0.1 to 50 MPa, comprising providing at least one support structure; providing a mold; applying the fibrous network to the mold by means of electro spinning of the one or more supramolecular compounds to obtain an implant; and separating the implant and mold.
Implant variant with circumferential fiber alignment
An implant for regenerating tissue in vivo comprising at least one support structure and a fibrous network consisting of one or more supramolecular polymer compounds, wherein the fibrous network has at least 60% porosity, pores with a diameter ranging from 1 to 300 micrometers, and a linear elastic stiffness ranging from 0.1 to 50 MPa, and wherein the fiber alignment of the fibrous network is circumferential.
Overall claim coverage is grounded in an in vivo tissue-regenerating implant architecture that combines support structures with a supramolecular polymer fibrous network constrained by porosity, pore diameter, and linear elastic stiffness, together with electrospinning onto a mold and circumferential fiber alignment.
Stated Advantages
Provides improved valve performance and reduced damage/fatigue for PCL-bisurea versus PCL.
Enables cell infiltration in an ovine model.
Documented Applications
Cardiovascular implant embodiments including a crimped cardiovascular implant associated with valve performance testing.
In vivo use in an ovine model with cell infiltration.
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