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EP-4739361-A1 - THREE-DIMENSIONAL IMPLANT WITH HYDROPHILIC SURFACE

EP4739361A1EP 4739361 A1EP4739361 A1EP 4739361A1EP-4739361-A1

Abstract

The disclosure provides a 3D tissue reconstruction implant having a hydrophilic implant surface and consisting of a bio-resorbable material, wherein the implant surface is considered hydrophilic when assessed using an ink test following ISO 8296:2003 and adapted to a 3D surface, wherein said ink test comprises incubating the implant for 1 min in a solution consisting of an ink with a surface tension of 72 mN/m and water and wherein after incubation of the implant in said solution an ink colored implant surface is indicative for a hydrophilic implant surface. The disclosure also provides said implant for use in tissue reconstruction, (soft) tissue support, tissue augmentation and/or implant revision and the use of said implant for reconstructing, augmenting and/or revising a tissue and/or supporting a (soft) tissue, respectively, wherein the implant is inserted into a patient. Further the disclosure provides a method of manufacturing a tissue reconstruction implant with a hydrophilic implant surface.

Inventors

  • Chhaya, Mohit Prashant

Assignees

  • BellaSeno GmbH

Dates

Publication Date
20260513
Application Date
20240703

Claims (17)

  1. 1. A tissue reconstruction implant, the implant having a hydrophilic implant surface, wherein the implant is a three-dimensional (3D) implant consisting of a bio-resorbable material, and wherein the implant surface is considered hydrophilic when assessed using an ink test following ISO 8296:2003 and adapted to a three-dimensional (3D) surface, wherein said ink test comprises incubating the implant for 1 min in a solution consisting of an ink with a surface tension of 72 mN/m and water, and wherein after incubation of the implant in said solution, an ink colored implant surface is indicative for a hydrophilic implant surface; wherein the implant comprises a three-dimensional (3D) lattice structure, wherein the 3D lattice structure i) defines a resting volume of the implant, ii) has a bulk porosity of at least 50%, and iii) is a reversibly compressible 3D lattice structure, wherein the 3D lattice structure is compressible to at least 80% of its resting volume.
  2. 2. The implant of claim 1, wherein i) the bio-resorbable material comprises, or is, a polymer selected from the group consisting of polycaprolactone, poly(l,3-trimethylene carbonate), polylactide, polyglycolide, poly(ester amide), poly(ethylene glycol)/poly(butylene terephthalate), poly(4-hydroxybutyrate), polydiaxanone, poly(glycerol sebacate), poly(l,8- octanediol-co-citric acid), poly(l,10-decanediol-co-D,L-lactic acid), poly(diol citrate), poly(glycolide-co-caprolactone), poly( 1,3 -trimethylene carbonate-co-lactide), poly(l,3- trimethylene carbonate-co-caprolactone) and a copolymer of at least two of said polymers, or ii) the bio-resorbable material comprises polycaprolactone, and/or iii) the bio-resorbable material is capable of being resorbed by a patient, preferably within less than 15 years upon insertion of the implant into said patient.
  3. 3. The implant of claim 1 or 2, wherein i) the implant is an additively manufactured implant, preferably a three-dimensionally (3D) printed implant, and/or ii) the filaments of the 3D printed implant have an average diameter between 25 pm and 7.5 mm, preferably between 50 pm and 5 mm or between 50 pm and 600 pm.
  4. 4. The implant of any one of the preceding claims, wherein the implant has a resting volume between 0.5 cm 3 and 40,000 cm 3 , preferably between 5 cm 3 and 25,000 cm 3 or between 5 cm 3 and 3000 cm 3 or between 5 cm 3 and 800 cm 3 .
  5. 5. The implant of any one of the preceding claims, wherein the porous network has an average pore size from 0.15 mm up to 12 mm or an average pore size from 0.5 mm up to 12 mm.
  6. 6. The implant of any one of the preceding claims, wherein the implant is i) a soft tissue implant and/or a soft tissue support implant, ii) for insertion into a patient, and/or iii) a single-piece reconstruction implant.
  7. 7. The implant of claim 6, wherein the soft tissue is a soft tissue of a) a breast region, pectoral region, malar region, gluteal region or genital region and/or b) a tendon and/or a ligament.
  8. 8. The implant of claim 6 or claim 7, wherein the soft tissue is a soft tissue of a breast region, pectoral region, malar region or gluteal region.
  9. 9. The implant of any one of the preceding claims, wherein the implant is suitable for being folded and/or compressed such that it can be inserted into a patient minimal invasively.
  10. 10. The tissue reconstruction implant of any one of claims 1 to 9 for use in tissue reconstruction, (soft) tissue support, tissue augmentation and/or implant revision, wherein the implant is inserted into a patient.
  11. 11. Use of the tissue reconstruction implant of any one of claims 1 to 9 for reconstructing, augmenting and/or revising a tissue and/or supporting a (soft) tissue, wherein the implant is inserted into a patient.
  12. 12. A method of manufacturing a tissue reconstruction implant with a hydrophilic implant surface, comprising exposing a surface of an implant to a surface treatment, wherein the surface treatment is suitable for making the surface of the implant hydrophilic, whereby a hydrophilic implant surface is obtained, wherein the implant is a three-dimensional (3D) implant consisting of a bio-resorbable material, and 60 wherein the implant surface is considered hydrophilic when assessed using an ink test following ISO 8296:2003 and adapted to a three-dimensional (3D) surface, wherein said ink test comprises incubating the implant for 1 min in a solution consisting of an ink with a surface tension of 72 mN/m and water, and wherein after incubation of the implant in said solution an ink colored implant surface is indicative for a hydrophilic implant surface; wherein the implant is manufactured by sequentially printing layers to form a 3D printed lattice structure comprising a plurality of unit cells, wherein the 3D printed lattice structure defines a resting volume of the implant, wherein a bulk porosity of the 3D lattice structure of the implant is at least 50%, wherein individual unit cells of the plurality of unit cells are reversibly compressible spring-like unit cells, wherein the 3D lattice structure is compressible to at least 80% of its resting volume.
  13. 13. The method of claim 12, wherein the implant is manufactured by sequentially printing layers to form a 3D printed lattice structure comprising a plurality of unit cells, wherein i) each printed layer comprises a lattice arrangement of 2D unit cells, ii) the unit cells are connected to each other, and/or iii) the filaments of the 3D printed lattice structure have an average diameter between 25 pm and 7.5 mm, preferably between 50 pm and 5 mm or between 50 pm and 600 pm.
  14. 14. The method of claim 12 or 13, wherein the surface treatment is i) an etching treatment, preferably an acid or alkaline etching treatment, more preferably a sodium hydroxide treatment, or ii) a plasma treatment, preferably an oxygen plasma treatment.
  15. 15. The method of any one of claims 12 to 14, wherein the plasma treatment i) is a low frequency plasma treatment, preferably at about 40 kHz, ii) is performed for at least 10 sec or at least 15 sec or at least 30 sec and/or for a period of time ranging between 10 sec and 240 min or between 15 sec and 240 min or between 15 sec and 90 min or between 15 sec and 60 min or between 15 sec and 30 min, iii) is performed by applying a used power of less than 70 watts (W) or of less than 40 W, and/or between 20 W and 70 W, preferably between 20 W and 40 W or between 50 W and 70 W, iv) is performed by applying a pressure of about 0.3 mbar, and/or 61 v) is performed by putting the implant on a glass tray in a plasma treatment device.
  16. 16. The method of any one of claims 12 to 15 or the implant of any one of claims 1 to 10, wherein the solution used in the ink test consists of the ink with the surface tension of 72 mN/m and distillate water, preferably in a ratio of ink:distillate water of between (about) 1 : 15 and (about) 1 :75, more preferably in a ratio of ink: distillate water of (about) 1 :60 or of (about) 1 :30.
  17. 17. A kit comprising the tissue reconstruction implant according to any one of claims 1 to 10 and/or obtainable or obtained by the method according to any one of claims 12 to 16 comprised in a packaging, preferably a multiple layer packaging, wherein preferably at least one of the layers is a moisture barrier and/or comprises or consists of polyethylene lined with aluminum. 62

Description

THREE-DIMENSIONAL IMPLANT WITH HYDROPHILIC SURFACE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims the right of priority of European patent application 23183089.4 filed with the European Patent Office on 03 July 2023, the entire content of which is incorporated herein for all purposes. FIELD OF THE INVENTION [0002] The present invention relates to a tissue reconstruction implant, the implant having a hydrophilic implant surface, wherein the implant is a three-dimensional (3D) implant consisting of a bio-resorbable material, and wherein the implant surface is considered hydrophilic when assessed using an ink test following ISO 8296:2003 and adapted to a three- dimensional (3D) surface, wherein said ink test comprises incubating the implant for 1 min in a solution consisting of an ink with a surface tension of 72 mN/m and water and wherein after incubation of the implant in said solution an ink colored implant surface is indicative for a hydrophilic implant surface. The present invention relates further to said tissue reconstruction implant for use in tissue reconstruction, (soft) tissue support, tissue augmentation and/or implant revision, wherein the implant is inserted into a patient, as well as to a use of said tissue reconstruction implant for reconstructing, augmenting and/or revising a tissue and/or supporting a (soft) tissue, wherein the implant is inserted into a patient. Further, the present invention relates to a method of manufacturing a tissue reconstruction implant with a hydrophilic implant surface, comprising exposing a surface of an implant to a surface treatment, wherein the surface treatment is suitable for making the surface of the implant hydrophilic, whereby a hydrophilic implant surface is obtained, wherein the implant is a three-dimensional (3D) implant consisting of a bio-resorbable material, and wherein the implant surface is considered hydrophilic when assessed using an ink test following ISO 8296:2003 and adapted to a three-dimensional (3D) surface, wherein said ink test comprises incubating the implant for 1 min in a solution consisting of an ink with a surface tension of 72 mN/m and water and wherein after incubation of the implant in said solution an ink colored implant surface is indicative for a hydrophilic implant surface. The present invention relates also to a kit comprising the tissue reconstruction implant according to the present invention and/or an implant obtainable or obtained by the method according to the present invention comprised in a packaging, preferably a multiple layer packaging, wherein preferably at least one of the layers is a moisture barrier and/or comprises or consists of polyethylene lined with aluminum. BACKGROUND [0003] Tissue reconstruction, (soft) tissue support, tissue augmentation and implant revision are often realized using an implant. This holds true for various tissues including e.g. soft tissues and bone tissues. [0004] Tissues requiring reconstruction, support, augmentation and/or revision may be soft tissues with breast tissues being a prominent example. For tissue reconstruction, support, augmentation and/or revision of breasts, silicone implants are primarily used. However, silicone implants have several drawbacks including, capsular contracture, delayed and/or chronic seroma, hematoma and implant-associated anaplastic large cell lymphoma. Additionally, silicone implants are subject to potential rupture, displacement and/or deformation. Undesired tissue stretching may be observed due to the implant's heavy load, especially in case of traditional silicone implants that may be filled with an incompressible fluid. Over time, silicone implants may also lead to the requirement of additional (corrective) surgeries or even may cause severe health issues when bursting. In view of the drawbacks of silicone implants, alternatives are currently under development. Some implants may include, e.g., space-occupying structures which may be filled with fluid. For example, International Patent Application WO 2016/038083 and Chhaya et al. (Transformation of Breast Reconstruction via Additive Biomanufacturing. Sci. Rep. 6, 28030; doi: 10.1038/srep28030; 2016) disclose an implant having a three-dimensional (3D) scaffold structure having voids, all of which are filled with space-occupying structures. The space-occupying structures are removable attached to the 3D scaffold structure and are configured to prevent invasion of tissue and/or of individual cells. For example, 6 to 8 weeks after implantation, the space-occupying structures are removed in a further surgery from the residual parts of the implant and the site of implantation. Thus, the use of such implants requires additional surgeries posing a further risk to the patients. Implants that do require the removal of such space-occupying structures have meanwhile also been described, e.g., in International Patent Application WO 2021/043950 and in International Patent Applica