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Researchers Submit Patent Application, "Three-Dimensional Polymeric Medical Implants", for Approval

August 28, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor MATHISEN, Torbjorn (Alvsjo, SE), filed on February 1, 2013, was made available online on August 14, 2014.

The patent's assignee is Novus Scientific Pte. Ltd.

News editors obtained the following quote from the background information supplied by the inventors: "Three-dimensional medical tissue implants are known. For example, U.S. Pat. No. 5,891,558 to Bell et al. discloses inter alia biopolymer foams as well as biocompatible constructs comprising such biopolymer foams, which can be used in medical implants to replace damaged or diseased tissue, or to provide scaffolds which, when occupied by e.g. host cells, are remodeled to become functional tissue. According to Bell et al. biopolymer foams can be reinforced by winding a biopolymer thread around a foam layer. Further, in U.S. Pat. No. 6,599,323 to Melican et al. it is suggested to reinforce a medical tissue implant, which comprises one or more layers of bioabsorbable polymeric foams, with a preferably bioabsorbable reinforcement component.

"For some medical implantation applications--such as scaffolds used predominantly for soft tissue augmentation in breast reconstruction or revision surgery, nipple regeneration, various facial augmentations like chin augmentation, various hernia applications, rhinoplasty and scaffolds used for various tissue engineering purposes where the scaffold is used as a substrate for proliferation of cells ex-vivo or in-vivo or a combination of both--the implant to be introduced into a human or animal body should possess a certain amount of load-bearing capacity without being too rigid, something which otherwise may cause problems during implantation or increased local tissue reactions due to modulus mismatch, especially in soft tissue. Three-dimensional implants where the porosity is higher than 70%, and especially those which are based on or contain a foam-like structure, will--even if reinforced with other structures, components or materials--have a limited ability to withstand compressing forces unless the implant in question is made from stiff materials and thus becomes stiff and non-compliant for most or all soft tissue applications. In unorganized structures such as foams it may also be difficult to control the load-bearing capacity during manufacture of the structures in question. Unorganized porous structures suffer also from varying pore homogeneity, i.e. the porosity is not necessarily the same for all portions of the unorganized structure. Further, in unorganized porous structures, properties like porosity, bending stiffness and compression stiffness are usually strongly related to each other, i.e. in practice it may be difficult to produce a medical implant having a desired porosity and, at the same time, a desired bending or compression stiffness. It is furthermore difficult or impossible to combine different materials and consequently different material properties into a single porous scaffold, which further augment the difficulties and limitations when it comes to design scaffolds with optimal properties for various clinical needs and indications."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "Consequently, there is a need for a three-dimensional resorbable polymeric medical implant having a structure which allows for rapid tissue in-growth in combination with possessing adequate mechanical properties, especially with regard to its ability to withstand compressing forces but still be easily adaptable to underlying tissue structures at the implant site, and whose mechanical properties are predictable, and easily controllable with high enough strengths as required for the specific clinical need. The medical implant should further have a pore homogeneity which is constant throughout the implant structure. Preferably, it should also be possible to provide the medical implant with a specific porosity and at the same time--and more or less independently of the chosen porosity--with a specific bending stiffness (that is, resistance to force applied in a direction perpendicular to the plane of the implant) by combining different materials or by varying the physical shape or morphology within any chosen material.

"The above objects are achieved by a three-dimensional resorbable polymeric medical implant described herein.

"In one embodiment of the present invention, a three-dimensional resorbable polymeric medical implant is provided, which comprises a porous component and a load-bearing component. The porous component is a substantially two-dimensional structure and is arranged as a layer or sheet. The load-bearing component is arranged on top of the porous component, and is optionally attached to the porous component. The load-bearing component has a height which is larger than the thickness of the porous component, and provides the medical implant with a three-dimensional configuration. The load-bearing component should be strong enough to withstand the compressing forces acting at the implantation site where the medical implant is to be surgically implanted. In accordance with the invention, the load-bearing component therefore comprises an open organized structure, which is a formed two-dimensional structure. The term 'formed two-dimensional structure' is defined below. The term 'open' means not closed.

"In another embodiment of the invention, the medical implant comprises a first porous component, a second porous component, and a load-bearing and volume-creating component, which is arranged between the first porous component and the second porous component such that a sandwiched three-dimensional structure is provided. Also in this embodiment, the load-bearing component comprises an organized structure, which is a formed two-dimensional structure as defined below.

"In further embodiments of the present invention, which can comprise two thin porous components, or only one thin porous component, as well as one load-bearing and volume-creating component, the medical implant has a rolled configuration. Other embodiments of the invention include means for controlling the bending stiffness of the present medical implant.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 illustrates schematically a first embodiment of a medical implant according to the present invention, which comprises a thin porous component and a load-bearing and volume-creating component, which has a corrugated shape and is arranged in connection to the thin porous component.

"FIG. 2 illustrates schematically a second embodiment of a medical implant according to the present invention, in which a medical implant comprising a thin porous component and a load-bearing and volume-creating component has been given a rolled configuration.

"FIG. 3 illustrates schematically a third embodiment of a medical implant according to the present invention, which comprises a first thin porous component, a second thin porous component, and a load-bearing and volume-creating component, which has a corrugated shape and is placed between the first and second thin porous components in a sandwich structure.

"FIG. 4 illustrates schematically a fourth embodiment of a medical implant according to the present invention, which comprises a first thin porous component, a second thin porous component, and a first load-bearing and volume-creating component, which has a corrugated shape and is placed between the first and second thin porous components, and a second load-bearing and volume-creating component, which has a corrugated shape and is arranged in connection to the second thin porous component, such that an aggregate sandwich structure is provided.

"FIG. 5 illustrates schematically a fifth embodiment of a medical implant according to the present invention, which comprises a first thin porous component, a second thin porous component, and a first load-bearing and volume-creating component, which has a corrugated shape and is placed between the first and second thin porous components, and a second load-hearing and volume-creating component, which has a corrugated shape and is arranged in connection to the second thin porous component, and a third thin porous component, which is arranged in connection to the second load-bearing and volume-creating component, such that an aggregate sandwich structure is provided.

"FIG. 6 illustrates schematically a sixth embodiment of a medical implant according to the present invention, which has the features of the embodiment shown in FIG. 1, but additionally provided with cuts, to decrease the bending stiffness of the medical implant in a first direction.

"FIG. 7 illustrates schematically a seventh embodiment of a medical implant according to the present invention, which has the features of the embodiment shown in FIG. 1, but additionally provided with extra connections, to increase the bending stiffness of the medical implant in a second direction.

"FIG. 8 illustrates schematically an eighth embodiment of a medical implant according to the present invention, which essentially has the features of the embodiment shown in FIG. 1, but wherein a corrugated structure has been given a more triangular cross-section.

"FIG. 9 illustrates schematically a ninth embodiment of a medical implant according to the present invention, which has essentially the features shown in FIG. 7, but wherein a corrugated structure has been given the shape of the Greek letter omega (.OMEGA.).

"FIG. 10 illustrates schematically a tenth embodiment of a medical implant according to the present invention, which comprises a thin porous component and a load-bearing and volume-creating component, which has a shape comprising elevations and depressions, and is arranged in connection to the thin porous component.

"FIG. 11 illustrates schematically an eleventh embodiment of a medical implant according to the present invention, which comprises a thin porous component and a load-bearing component and which has been given a pre-formed, curved shape."

For additional information on this patent application, see: MATHISEN, Torbjorn. Three-Dimensional Polymeric Medical Implants. Filed February 1, 2013 and posted August 14, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1467&p=30&f=G&l=50&d=PG01&S1=20140807.PD.&OS=PD/20140807&RS=PD/20140807

Keywords for this news article include: Novus Scientific Pte. Ltd.

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Source: Politics & Government Week


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