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US 8,282,912 B2Granted
Compositions for tissue augmentation
AssigneeKuros Biosurgery AG
InventorsAaldert Rens Molenberg, Enrico Zamparo, Laurent Rapillard, Simona Cerritelli
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AssigneeKuros Biosurgery AG
InventorsAaldert Rens Molenberg, Enrico Zamparo, Laurent Rapillard, Simona Cerritelli
Estimating the term…
Methods for making biomaterials for augmentation of soft and hard tissues, kits containing precursors for forming the biomaterials, and the resulting biomaterials are described herein. The biomaterials are formed from at least a first and a second precursor component. The first precursor component contains at least two nucleophilic groups, and the second precursor component contains at least two electrophilic groups. The nucleophilic and electrophilic groups of the first and second precursor components form covalent linkages with each other at physiological temperatures. The precursors are selected based on the desired properties of the biomaterial. In the preferred embodiment, the first precursor is a siloxane. Optionally, the biomaterials contain additives, such as thixotropic agents, radiopaque agents, or bioactive agents. In the preferred embodiment, the biomaterials are used to augment at least one vertebra of the spine (vertebroplasty).
A method for augmenting hard tissue, comprising applying to the tissue a composition comprising at least a first and a second precursor component,
A biomaterial for augmenting hard tissue comprising a polymeric network formed from a composition comprising at least a first and a second precursor component, wherein the first component comprises at least m nucleophilic groups and the second component comprises at least n conjugated unsaturated groups,
A kit for forming in situ crosslinkable composition for augmenting a hard tissue comprising at least a first precursor component and a second precursor component,
Dependencies are inferred from the claim text.
From the US filing history. Foreign family members aren’t listed.
Macromolecular materials: mixtures of macromolecular compounds
Materials characterised by their function or physical properties: flowable or injectable implant compositions
Materials or treatment for tissue regeneration: for reconstruction of the spine, vertebrae or intervertebral discs
Methods or apparatus for sterilising materials or objects in general
Term ended 6 Dec 2023 (estimated)
The present invention relates to biomaterials for tissue augmentation, precursor components capable of forming the biomaterials and, methods of making and using thereof. In particular, the present invention relates to the in situ formation of biomaterials for augmentation of soft and/or hard tissues.
Synthetic materials have been investigated for implantation in the body to assist in surgical reconstruction and repair. Biomaterials of synthetic polymeric origin have been used for tissue related applications, such as tissue regeneration matrices, tissue adhesives, drug delivery matrices, for the prevention of surgical adhesions, as coatings for synthetic implants and as tissue augmentation materials. Depending on the chemical structure of the precursor components and their stoichiometry, the biomaterials have varying physical and chemical properties.
Orthopedic Surgery
FIG. 1A shows a comparison of Young's modulus (MPa) between a control and an augmented group of vertebrae for both low and high volume fractions (VF) (*p<0.05).
FIG. 1B shows a comparison of strength (MPa) between a control and an augmented group of vertebrae for both low and high volume fractions (VF) p<0.05).
FIG. 2 is a graph showing the maximal applied stress (Smax) divided by volume fraction (FV) (MPa) versus the number of cycles to failure (N), which compares the fatigue result of augmented trabecular bone (augmented group) to non-augmented trabecular bone (control group).
I. Definitions
“Biomaterial” or “Pharmaceutical composition” as generally used herein refers to a material intended to interface with biological systems to evaluate, treat, augment, or replace any tissue, organ or function of the body. Biomaterial refers to the complete material (precursor plus all additives, bioactive agents, fillers, initiators (e.g., base) and/or solvents, etc.) at and after having reached and passed its gel-point.
“Mixture of precursor components” as generally used herein refers to the precursor components after being mixed and before the mixture has reached its gel-point.