Three-dimensional medical implant for regeneration of soft tissue

Abstract

The present disclosure relates to a three-dimensional, degradable medical implant for regeneration of soft tissue comprising a plurality of volume-building components (20) and a mesh component (22) which is substantially made of monofilament or multifilament fibers, wherein each volume-building component (20) is attached to at least one point on a surface of the mesh component (22), and wherein the projected surface area of each volume-building component (20), when projected on the surface of the mesh component (22), corresponds to a maximum of one tenth of the surface area of the mesh component.

1 .- 26 . (canceled) 
     
     
         27 . A three-dimensional, degradable medical implant for regeneration of soft tissue comprising:
 a first plurality of volume-building components;   a first mesh component which is substantially made of monofilament or multifilament fibers; characterized in   that each volume-building component is attached to at least one point on a surface of the mesh component, and   that the projected surface area of each volume-building component, when projected on the surface of the mesh component, corresponds to a maximum of one tenth of the surface area of the mesh component.   
     
     
         28 . The medical implant according to  claim 27 , wherein each of the volume-building components comprises a scaffold component, which scaffold component comprises a material which is chosen from a group consisting of (i) a hydrogel, (ii) a porous material, or (iii) fibers, or any combination thereof. 
     
     
         29 . The medical implant according to  claim 28 , wherein at least one of the volume-building components further comprises a support structure, which is characterized by having a higher compression modulus than the scaffold component. 
     
     
         30 . The medical implant according to  claim 27 , wherein the plurality of volume-building components comprises at least 5 volume-building components, such as at least 10, 50, 100, or 1000 volume-building components. 
     
     
         31 . The medical implant according to  claim 27 , wherein the volume-building components are spaced apart by a distance including from 0.2 mm to 5.0 mm, preferably including from 0.3 to 3.0 mm. 
     
     
         32 . The medical implant according to  claim 29 , wherein the support structure of each of the volume-building components comprises (i) a frame-shaped structure, (ii) a spring-shaped structure, or (iii) a dome-shaped structure. 
     
     
         33 . The medical implant according to  claim 32 , wherein the support structures of the plurality of volume-building components comprise the same shape chosen from (i)-(iii) or a combination of different shapes chosen from (i)-(iii). 
     
     
         34 . The medical implant according to  claim 29 , wherein the support structure of at least one of the volume-building components has slits, pores or through-holes in its walls. 
     
     
         35 . The medical implant according to  claim 27 , further comprising a second mesh component, which is attached to at least two of the first plurality of volume-building components, to create a sandwich structure. 
     
     
         36 . The medical implant according to  claim 35 , further comprising a second plurality of volume-building components, wherein each of the second plurality of volume-building components is attached to at least one surface of the second mesh component, to create a sandwich structure. 
     
     
         37 . The medical implant according to  claim 35 , wherein the medical implant has a radius of curvature in one direction which is at least 5 cm, such as 10, 15, or 20 cm. 
     
     
         38 . The medical implant according to  claim 36 , further comprising a third mesh component, separated from the second mesh component by volume-building components, wherein the medical implant has a radius of curvature in one direction which is at least 10 cm, such as 15, 20, 25, or 30 cm. 
     
     
         39 . The medical implant according to  claim 27 , wherein the projected surface area of each volume-building component is in an interval including from 0.25 to 3.0 cm 2 , such as 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, or 3.0 cm 2 . 
     
     
         40 . The medical implant according to  claim 27 , wherein the volume of each volume-building component is in an interval including from 0.12 to 3.0 cm 3 , such as 0.28, 0.5, 1.0, 1.5, 2.0, 2.5, or 3.0 cm 3 . 
     
     
         41 . The medical implant according to  claim 28  (i), wherein the hydrogel of the scaffold component is substantially based upon collagen, gelatin, fibrin, hyaluronic acid, alginate, chitosan, chondroitin sulphate, agarose, polyethylene glycol as a block in copolymers with any of the monomers lactide, glycolide, trimethylene carbonate, ε-caprolactone or paradioxanone, or any combination thereof. 
     
     
         42 . The medical implant according to  claim 28  (ii), wherein the porous material of the scaffold component is characterized by being degradable and having a Tg higher than 40° C. or a melting point higher than 50° C. such as homopolymers or copolymers, random or block, or blends of such homopolymers or copolymers which include one or more of the following monomers glycolide, lactide, paradioxanone, trimethylene carbonate, ε-caprolactone or 1,5-dioxepan-2-one, or polymers or copolymers of β-hydroxybutyrate or γ-hydroxybutyrate or copolymers containing ethylene carbonate units, or any combination thereof. 
     
     
         43 . The medical implant according to  claim 28  (iii), wherein the fibers of the scaffold component are substantially made of degradable homopolymers or copolymers, random or block, or blends of such homopolymers or copolymers synthesized from any of the monomers glycolide, lactide, paradioxanone, trimethylene carbonate, ethylene carbonate, ε-caprolactone, 1,5-dioxepan-2-one, polymers or blends mainly based upon poly-γ-butyrolactone or poly-β-butyrolactone, or fibers derived from natural occurring materials, such as chitosan or fibroin, or any combination thereof. 
     
     
         44 . The medical implant according to  claim 29 , wherein the support structure is substantially made from degradable polymers synthesized from lactide, glycolide, paradioxanone, c-caprolactone, trimethylene carbonate or any combination thereof in random or block copolymers, or amorphous variants such as poly-D,L-lactide and certain amorphous copolymers between D,D- and L,L-lactide, or any combination thereof. 
     
     
         45 . The medical implant according to  claim 27 , wherein at least one mesh component is warp-knitted. 
     
     
         46 . The medical implant according to  claim 27 , wherein at least one mesh component is substantially made from degradable homopolymers, or copolymers, random or block, or blends of degradable homopolymers or copolymers which include one or more of the following monomers glycolide, lactide, paradioxanone, trimethylene carbonate, ε-caprolactone or 1,5-dioxepan-2-one, or polymers or copolymers of β-hydroxybutyrate or γ-hydroxybutyrate or copolymers containing ethylene carbonate units, or any combination thereof. 
     
     
         47 . Use of a medical implant according to  claim 27  to stabilize a breast prosthesis and to provide space between flap tissue and the breast prosthesis to allow for tissue regeneration, wherein the medical implant is placed in close apposition to the breast prosthesis. 
     
     
         48 . A method for breast reconstruction in an individual, comprising placing a medical implant according to  claim 27  in close apposition to a breast prosthesis in the individual to stabilize the breast prosthesis and to provide space between flap tissue and the breast prosthesis to allow for tissue regeneration.