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WO2018212726A2 - Extenseur de tissu et procédé de production associé - Google Patents

Extenseur de tissu et procédé de production associé Download PDF

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Publication number
WO2018212726A2
WO2018212726A2 PCT/TR2017/000100 TR2017000100W WO2018212726A2 WO 2018212726 A2 WO2018212726 A2 WO 2018212726A2 TR 2017000100 W TR2017000100 W TR 2017000100W WO 2018212726 A2 WO2018212726 A2 WO 2018212726A2
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WO
WIPO (PCT)
Prior art keywords
hydrogels
tissue expander
aam
acrylamide
hema
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/TR2017/000100
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English (en)
Other versions
WO2018212726A3 (fr
Inventor
Menemşe Gümüşdereli̇oğlu
Tuğrul Tolga Demi̇rtaş
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Individual
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Individual
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Publication of WO2018212726A2 publication Critical patent/WO2018212726A2/fr
Publication of WO2018212726A3 publication Critical patent/WO2018212726A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces

Definitions

  • the present invention relates to a hydrogel-based tissue expander which releases controlled antibacterial agent in a controlled way in order to reduce the risk of infection in wound healing period when the tissue is in the weakest condition and a production method of this tissue expander.
  • Tissue expansion is a physiological phenomenon occurring at all stages of life, pregnancy and obesity.
  • Tissue expansion method is based on the principle of covering tissues expand their surface areas to the slowly-growing masses under thereof and comply with them. This method for tissue expansion purpose is used in order to promote growth of skin, bone or other tissues located at any part of the body.
  • Tissue expansion is a quite simple process which enables body to create over skin for reconstruction application at any area of the skin. Tissue expansion method has attained an important place in plastic and reconstructive surgery applications over the last thirty years. Devices being used in this technique are called as tissue expanders.
  • a tissue expansion technique which was defined for ear reconstruction at first in the literature has become an alternative treatment for many clinical problems recently.
  • tissue expanders have become usable in every region -for example skin, muscle, connective tissue and nerves- wherein an expandable tissue resides.
  • tissue expanders When tissue expanders are applied to some regions of the body and swollen at certain intervals, they enable expansion of the skin in the applied region and allow the skin to be used in other regions.
  • Shape and size of the tissue expander to be used are determined according to the damage and the condition of the contiguous healthy tissue. Methods have been considerably developed about this technique being used for many years. Tissue expanders are used in a wide variety of areas of the body; namely, losses in scalp, tissue deficiencies in the chest region, burn treatments, baldness problems, correction of scars, neck, arms and legs.
  • Soft tissue expanders are surgical materials which are used in fields such as dental-maxillofacial surgery, plastic surgery and give quite good results. Particularly, it is of great importance to develop suitable tissue expanders to be used for repair tissue losses resulting from tumor or any trauma.
  • tissue expanders wherein hydrogels are used as tissue expander, are produced in different sizes so as to be used in different applications.
  • some complications such as wound dehiscence, exposition of tissue expander and tissue necrosis in applications of the said soft tissue expanders.
  • hydrogels are formed by reacting a hydrophilic monomer with a first and a second crosslinker.
  • the first crosslinker defines the volume expansion of the hydrogel in an aqueous environment.
  • the second crosslinker which is biodegradable, can modulate the swelling rate of the hydrogel in an aqueous environment.
  • hydrogel xerogel
  • hydrogel is flexible and elastic in its dry state and it can also be cut with a knife or scissors, or molded or shaped by hand.
  • hydrogel xerogel
  • US5941909 discloses a soft tissue implant filling material. It is disclosed that the said filling material is a hydrogel comprising polyacrylamide and derivatives thereof and it comprises an outer shell or membrane. It is disclosed that the hydrogel described in the said document is suitable for use with antibacterials.
  • the International patent document no. WO2015160699 discloses a tissue expander comprising chemically cross-linked and biodegradable hydrogels which are elastic in the dry state.
  • the biodegradable tissue expanders disclosed in the said invention are self-inflating and membrane-free. The said tissue expanders swell slowly and elicit minimal negative tissue responses, while allowing for rapid and easy manipulation at the time of emplacement. It is also disclosed in the said document that the tissue expander hydrogel comprises medicines such as antibiotics.
  • An objective of the present invention is to realize a tissue expander which swells in a slow and controlled way after it is placed under the skin because the fact that it swells quickly causes tissue necrosis or wound dehiscence, no sufficient time can be provided for tissue growth and efficiency of tissue expansion is limited; expands by means of osmotic pressure
  • Another objective of the present invention is to realize a hydrogel-based tissue expander which prevents hydrogel -no water absorbed to its structure- from damaging the tissue during the operation and while placing implant due to the fact that it has a vitreous and rigid structure.
  • Another objective of the present invention is to realize a hydrogel-based tissue expander which releases antibacterial agent in order to prevent infection formation during surgery (intraoperatively) and after surgery (postoperatively).
  • Figure 1 is a flowchart of the inventive method.
  • FIGS. 1 and 2 are SEM images of PCL-AMX (polycaprolactone-amoxicillin) nanofibers obtained at 3% and 5% AMX (amoxicillin) concentrations, after electrospinning transaction of 40 minutes and 80 minutes:
  • Figure 3 is swelling graphic of hydrogels with silicon shell p (AAm-co-
  • HEMA HEMA
  • Figure 4 is swelling graphic of p(AAm-co-HEMA) (poly(acrylamide-co- 2-hydroxyethyl methacrylate)) hydrogels with silicon shell glycerine wherein hole is covered with PCL-AMX (polycaprolactone-amoxicillin) nanofiber electrospun for 40 min and 80 min in an embodiment of the inventive tissue expander.
  • p(AAm-co-HEMA) poly(acrylamide-co- 2-hydroxyethyl methacrylate) hydrogels with silicon shell glycerine wherein hole is covered with PCL-AMX (polycaprolactone-amoxicillin) nanofiber electrospun for 40 min and 80 min in an embodiment of the inventive tissue expander.
  • Figure 5 are FTIR spectra of hydrogels in an embodiment of the inventive tissue expander:
  • Figure 6 is antibacterial agent release profile from PCL (polycaprolactone) nanofibers of 5 mm x 5mm in an embodiment of the inventive tissue expander:
  • the inventive tissue expander used for repairing tissue losses, swells in a controlled way and prevents infection formation essentially comprises:
  • At least one hydrogel which is produced in predetermined sizes according to its region, is self-swellable by means of osmotic pressure and is waited inside glycerine solution;
  • - at least one shell which delays contact of hydrogel with water, surrounds the hydrogel such that it will form a membrane on the exterior surface of the hydrogel in order to control swelling rate of hydrogel, has at least one hole; - at least one nanofiber matrix which covers the hole located on the shell and comprises antibacterial agent.
  • the said hydrogel comprised by the inventive tissue expander is poly(acrylamide- co-2-hydroxyethyl methacrylate) (p(AAm-co-HEMA)) hydrogel.
  • p(AAm-co-HEMA) poly(acrylamide- co-2-hydroxyethyl methacrylate)
  • HEMA 2-hydroxyethyl methacrylate
  • AAm acrylamide
  • hydrogels which comprise the hydroxyl and amide groups included in the inventive tissue expander and which are hydrophilic monomers can be synthesized easily and their mechanical endurance are high. In addition, they have a wide area of usage because they are not absorbed by body.
  • Hydrogels comprised by the inventive tissue expander reach balance swelling values approximately in one day. Due to the fact that they are highly hydrophilic, these hydrogels are quickly absorbed to the water structure as soon as they contact water. Existence of glycerine in the structure of hydrogel waited inside the glycerine solution in the inventive tissue expander, reduces swell ratio values slightly. Glycerine reduces contact of water and hydrogel because it is hydrophobic. Hydrogel starts taking water upon the glycerine exits the structure after being put into aqueous medium, and swelling capacity of hydrogel increases.
  • the hydrogels comprised by the inventive tissue expander penetrate gel structures by means of osmotic pressure.
  • the gel structure which is in contact with water continues swelling until it reaches the swelling balance. Swelling can be slowed by preventing diffusion of the liquid into the hydrogel.
  • a swelling-controlled system can be obtained. It is enabled to control the swelling rate of the shell hydrogels included around the hydrogel in the inventive tissue expander.
  • shells which are biocompatible in medical quality, made of silicone enabling swelling of the hydrogel placed into thereof by means of its elastic feature are used.
  • the part at the end of the shell is preferably adhered by silicone adhesive.
  • the nanobiber matrix which covers the hole located on the shell in the inventive tissue expander and wherein antibacterial agent is loaded in order to avoid infection formation, enables to control diffusion of water into hydrogel and release of the antibacterial loaded to the matrix in a controlled way as well.
  • the inventive tissue expander By reducing the swelling rate of the inventive tissue expander placed under the tissue during the recovery period of first 10 days, it was detected that the balance swelling value by percentage in this period is approximately valued at %35. It was determined that the inventive tissue expander is not cytotoxic and it has antibacterial characteristic.
  • the production method of the inventive tissue expander (1) comprises steps of:
  • acrylamide (AAm) and 2-hydroxyethyl methacrylate (HEMA) monomers are preferably used in the ratio of 94.5:5.5% by mole in order to synthesize poly(acrylamide-co-2-hydroxyethyl methacrylate) hydrogels (2).
  • HEMA 2-hydroxyethyl methacrylate
  • acrylamide (AAm) and 2-hydroxyethyl methacrylate (HEMA) monomers preferably ⁇ , ⁇ '-methylene bisacrylamide (BIS) is used as cross-linker, ammonium persulfate (APS) is used as initiator and ⁇ , ⁇ , ⁇ ', ⁇ '- tetramethylenediamine (TEMED) is used as initiator catalyst.
  • the step of synthesizing poly(acrylamide-co-2- hydroxyethyl methacrylate) (P(AAm-co-HEMA)) hydrogels with free radical polymerization and cross-linking reactions (2) is carried out in glass tubes in 4 mm x 150 mm sizes in one preferred embodiment.
  • a Am is taken to the tube and it is mixed again by adding HEMA monomer on thereof after it is dissolved in distilled water completely.
  • cross-linking agent, initiator and initiator catalyst are added to this mixture quickly and the tube is closed and the solution is mixed in the mixer.
  • the said solution is mixed for 2 minutes, then pipetted and taken into glass tubes of preferably 4 mm.
  • the solution prepared for the said hydrogel synthesis (2) is waited at room temperature for 30 to 60 minutes and it is enabled to continue the polymerization.
  • the solution prepared for completing the polymerization reaction is waited at room temperature for 30 minutes and it is enabled to continue the polymerization.
  • the glass tubes are broken carefully and hydrogels in cylindrical bar form are taken out. Then, the cylindrical hydrogel samples are sliced by means of bistoury and uniform gels are obtained.
  • the hydrogels synthesized in the inventive method (1) are subjected to a washing process of three days in a distilled water in order to remove non-reacting monomers and other components in their structure and then cylindrical hydrogels are dried preferably at 37°C temperature and under 25 mm Hg atmospheric pressure (3). As a result of the drying process, hydrogels in 2mm diameter and 10 mm thickness are obtained.
  • the hydrogels obtained by washing and drying (3) after the synthesizing process (2) in the inventive method (1) are waited inside glycerine solution (4) due to the fact that manipulation of hydrogels -no water absorbed to their structure- is difficult because they have a vitreous and rigid structure and in order to prevent them from damaging the tissue while placing implant during the operation.
  • the hydrogels obtained are waited in glycerine solution of 70 %.
  • the hydrogels synthesized (2), dried upon being washed (3) and then waited inside glycerine solution (4) in the inventive method (1) are placed into a shell which surrounds the hydrogel such that it will form a membrane on the exterior surface of the hydrogel and delays contact of the hydrogel with water in order to control the swelling rate of the hydrogel (5).
  • the balance swelling rate by percentage (on dry basis) of the hydrogels waited inside the glycerine solution (4) and placed into the shell (5) in order to slow the swelling rate of the hydrogels, is approximately between 400 % to 500 % and this value was reached in 1 month.
  • the hole located on the shell in the inventive method (1) is covered with the nanofiber matrix releasing antibacterial agent in order to reduce the risk of infection during surgery and after surgery for use of the inventive tissue expander (1) (6).
  • the nanofiber matrix comprises amoxicillin as the antibacterial agent.
  • the nanofiber matrix comprises amoxicillin in the ratio of 3% to 10, preferably in the ratio of % 3% to 5%.
  • the said nanofiber matrix is of biodegradable nature and in one preferred embodiment of the invention, polycaprolactone-amoxicillin (PCL-AMX) nanofiber matrices are produced by using electrospinning technique.
  • electrospinning solution comprising PCL (polycaprolactone) (molecular weight: 80,000) in the ratio of 10% to 12% (weight/volume) and amoxicillin in the ratio of 3% to 10% by weight is prepared by using 1, 1,1, 3,3,3 -hexfloro-2- propanol (HFIP) as solvent in production of PCL-AMX (polycaprolactone- amoxicillin) nanofiber matrix.
  • PCL polycaprolactone
  • HFIP 1, 1,1, 3,3,3 -hexfloro-2- propanol
  • electrospinning solution comprising PCL (polycaprolactone) (molecular weight: 80,000) in the ratio of 11% and amoxicillin in the ratio of 3% and 5% by weight is prepared.
  • PCL polycaprolactone
  • nanofiber matrices comprising antibacterial agent are produced by using conditions in the production of antibacterial agent free-nanofiber. Collection times are practiced as 40 min to 120 min in production of polycaprolactone (PCL) nanofiber matrices loaded with amoxicillin.
  • collection time of polycaprolactone (PCL) nanofiber matrices loaded with amoxicillin is 40 minutes. In another preferred embodiment of the invention, collection time of polycaprolactone (PCL) nanofiber matrices loaded with amoxicillin is 40 minutes.
  • PCL-AMX polycaprolactone
  • electrospinning transaction is carried out by values of 27.5 kV power and 2 mL h flow rate by fixing the distance between the syringe needle and the collector such that it will be 35 cm.
  • diameters of the PCL-AMX (polycaprolactone-amoxicillin) nanofibers produced are calculated over their SEM images ( Figure 2) thereof.
  • the hole located in the shell is covered with the nanofiber matrix -which is cut from PCL-AMX (polycaprolactone-amoxicillin) nanofiber matrix obtained in preferably 5 mm x 5 mm size and releases antibacterial agent in a controlled way- upon being adhered by silicone adhesive.
  • PCL-AMX polycaprolactone- amoxicillin
  • PBS phosphate buffered saline solution
  • release study was initiated. Cumulative release in PBD medium was assessed by Nanodrop device at 229 nm. To prevent microbial contamination, sodium azide (0.09% w/v) was added to the release medium. Amounts of antibacterial release were assessed by Nanodrop device by taking 2.5 mL sample from the release medium at certain intervals during the release.
  • PCL (polycaprolactone) matrices comprising 5% (by weight) amoxicillin in 2 cm x 2cm and 5 mm x 5 mm sizes and PCL (polycaprolactone) matrices in the same sizes were used in order to create control group. Also, antibacterial efficiency of commercially available amoxicillin disc ⁇ g/6mm disc, Bioanalysis ® , Turkey) was examined as well.
  • PCL-AMX polycaprolactone-amoxicillin
  • PCL polycaprolactone
  • A mg/6 mm paper disc.
  • a suitable antibacterial agent was made in order to avoid formation of infection by the tissue expander obtained with the inventive method (1) and it is ensured that diffusion of water into hydrogel is controlled by loading this agent (amoxicillin, AMX) PCL (polycaprolactone) matrix and covering the hole in 0.5 mm diameter that is located on the shell and also, controlled release of the antibacterial was provided.
  • this agent amoxicillin, AMX
  • PCL polycaprolactone

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un extenseur de tissu à base d'hydrogels qui libère un agent antibactérien de façon régulée afin de réduire le risque d'infection pendant une période de cicatrisation de plaie, lorsque le tissu se trouve dans son état le plus faible, ainsi qu'un procédé de production (1) de cet extenseur de tissu.
PCT/TR2017/000100 2016-10-11 2017-09-22 Extenseur de tissu et procédé de production associé Ceased WO2018212726A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR201614282 2016-10-11
TR2016/14282 2016-10-11

Publications (2)

Publication Number Publication Date
WO2018212726A2 true WO2018212726A2 (fr) 2018-11-22
WO2018212726A3 WO2018212726A3 (fr) 2019-01-03

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5941909A (en) 1995-02-14 1999-08-24 Mentor Corporation Filling material for soft tissue implant prostheses and implants made therewith
WO2007016371A2 (fr) 2005-07-28 2007-02-08 Akina, Inc. Xerogels pouvant etre faconnes et possedant des proprietes de gonflement a retard controlable
WO2015160699A1 (fr) 2014-04-14 2015-10-22 Akina, Inc. (An Indiana (Us) Corp) Nouveaux dilatateurs de tissus de type hydrogel

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5941909A (en) 1995-02-14 1999-08-24 Mentor Corporation Filling material for soft tissue implant prostheses and implants made therewith
WO2007016371A2 (fr) 2005-07-28 2007-02-08 Akina, Inc. Xerogels pouvant etre faconnes et possedant des proprietes de gonflement a retard controlable
WO2015160699A1 (fr) 2014-04-14 2015-10-22 Akina, Inc. (An Indiana (Us) Corp) Nouveaux dilatateurs de tissus de type hydrogel

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