Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
• • 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
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/02—Inorganic materials
  • A61L27/04—Metals or alloys
• • 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
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/28—Materials for coating prostheses
  • A61L27/34—Macromolecular materials
• • 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
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/02—Inorganic materials
• • 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
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/08—Materials for coatings
  • A61L29/085—Macromolecular materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00831—Material properties
  • A61B2017/00836—Material properties corrosion-resistant
• • 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
  • A61L2400/10—Materials for lubricating medical devices

Definitions

• PPE polyphenyl ether
• Stainless steel and related alloys vary in corrosion resistance based upon their composition and exposure to various environments. Certain medical device alloys require the application of a preservative film to prevent corrosion. Water-based lubricant preservatives are unsuitable for some medical device materials, in particular, articulating instruments that are less corrosion resistant. Straight- chain hydrocarbons and silicone-based lubricants suffer from radiation damage that can render them less effective or toxic. Polytetrafluoroethylene (PTFE) based lubricants cannot withstand gamma radiation at typical sterilizing doses (20-25 kGy) without significant degradation.
• PTFE polytetrafluoroethylene
• PPEs Polyphenyl ethers
• a surgical instrument including a metal surface configured to contact a surgical patient, and a biocompatible polymeric coating over the metal surface, wherein the polymeric coating includes a polyphenyl ether polymer, and wherein the coating slows the rate of corrosion of the metal surface during storage.
• Various embodiments disclosed herein relate to a method of treating a metal surface of a surgical instrument to improve corrosion resistance, wherein the method includes coating the metal surface with a biocompatible polymeric coating, wherein the coating includes a polyphenyl ether polymer.
• the polyphenyl ether polymer is a five-ring polyphenyl ether.
• the metal is a stainless steel or molybdenum alloy.
• the coating is resistant to degradation by gamma radiation.
• the medical device is either sterile or non-sterile.
• FIG. 1 shows the DATR Spectra of Gamma-Sterilized (43-58 kGy) SANTOTUBE® OS-124 Coated Fluted Drums (Anspach Packaged).
• FIG. 2 shows the DATR Spectra of non-sterile SANTOTUBE® OS-124 Coated Fluted Drums (Millstone Packaged).
• FIG. 3 shows the preservation of a non-sterile SANTOTUBE® OS-124 Coated Fluted Drum, 4 weeks post-manufacturing.
• FIG. 4 shows the preservation of a sterile SANTOTUBE® OS-124 Coated Fluted Drum, 4 weeks post-manufacturing.
• the present disclosure provides for the use of polyphenyl ether (PPE)-based polymeric coatings as non-toxic, radiation stable lubricants and corrosion preventatives for medical devices, such as metal surgical instruments configured to contact surgical subjects.
• PPE-based polymeric coatings are formulated to be resistant to degradation by gamma radiation or heat and provides a conformal barrier to corrosion.
• the PPE-based coatings of the present disclosure are biocompatible, can withstand both steam and gamma radiation sterilization and retain biocompatibility following sterilization.
• the PPE-based coatings further exhibit excellent resistance to oxidation, including oxidative resistance above 100°C.
• the present disclosure further provides for surgical instruments which contain at least one metal surface and a biocompatible PPE-based polymeric corrosion resistant coating coated thereon, wherein the coating slows the rate of corrosion during the storage life of the instrument.
• a“polymeric” material is one that contains one or more types of polymers, commonly containing at least 50 wt% to 75 wt%, to 90 wt% to 95 wt% to 99 wt% or even more polymers.
• polymeric materials include those containing a single type of polymer as well as polymer blends.
• polymers are molecules that contain multiple copies of one or more constitutional units, commonly referred to as monomers, and typically contain from 5 to 10 to 25 to 50 to 100 to 500 to 1000 or more constitutional units. Polymers may be, for example, homopolymers, which contain multiple copies of a single constitutional unit, or copolymers, which contain multiple copies of at least two dissimilar constitutional units, which units may be present in any of a variety of distributions including random, statistical, gradient, and periodic (e.g., alternating) distributions.
• the PPE-based polymeric coating of the present disclosure may be used to lubricate surgical instruments or other sterile and non-sterile medical devices.
• Suitable PPE polymers include six-ring polyphenyl ether polymers, five-ring polyphenyl ether polymers, four-ring polyphenyl ether polymers, three- and four-ring oxy- and thioether polymers, three-ring polyphenyl ether polymers, two-ring diphenyl ether polymers, and combinations thereof.
• the PPE-based polymeric coating preferably contains a five-ring polyphenyl ether polymer.
• the PPE-based coating may also contain other polymeric materials selected from: polycarboxylic acid polymers and copolymers including polyacrylic acids; acetal polymers and copolymers; acrylate and methacrylate polymers and copolymers (e.g., n-butyl methacrylate); cellulosic polymers and copolymers, including cellulose acetates, cellulose nitrates, cellulose propionates, cellulose acetate butyrates, cellophanes, rayons, rayon triacetates, and cellulose ethers such as carboxymethyl celluloses and hydroxyalkyl celluloses; polyoxymethylene polymers and copolymers; polyimide polymers and copolymers such as polyether block imides and polyether block amides, polyamidimides, polyesterimides, and polyetherimides; polyamide polymers and copolymers including nylon 6,6, nylon 12, polycaprolactams and polyacrylamides; resins including alkyd resins,
• Preferred polymeric materials of the present disclosure are biocompatible and non-cytotoxic as determined using the MEM Elution subjective scoring method (Grade 0-4), wherein a passing score is Grade 0 or Grade 1. Other tests for biocompatibility and cytotoxicity may also be used and are known to those skilled in the art.
• Preferred polymeric materials also provide corrosion resistance to the coated surgical instrument for at least 4 weeks upon storage of the instrument.
• Preferred polymeric materials further provide gamma-radiation resistance to at least a level of 20 kGy, preferably 40-50 kGy, to the coated surgical instrument so as to prevent degradation of the PPE-based coating that would adversely affect corrosion resistance or biocompatibility of the instrument.
• Specific medical devices that may be lubricated using the PPE-based coating include any surgical instruments having a metal surface.
• Exemplary surgical instruments include surgical scissors and other cutting instruments, electro surgical instruments, cautery instruments, needle holders, osteotomes and periosteotomes, chisels, gouges, rasps, files, saws, reamers, wire twisting forceps, wire cutting forceps, ring handled forceps, tissue forceps, cardiovascular clamps, rongeurs, or any other hard metal instrument having teeth, serrations, a cutting edge or being otherwise susceptible to corrosion.
• Specific hard metals that may be coated with the PPE-based coating of the present disclosure include steel-based materials including stainless steel, titanium or titanium alloy, iron-nickel alloy and molybdenum or molybdenum alloy or combinations thereof.
• Preferred hard metals include stainless steel alloy 15-5PE1, 17-5PE1, 300 series, 400 series; and M series steel molybdenum alloys or combinations thereof.
• Specific examples include high carbon martensitic stainless steel (e.g. Stainless steel Type 440A), high speed tool stainless steels containing molybdenum and tungsten, but not cobalt (e.g. Ml and M2), and high speed tool stainless steel alloys containing molybdenum, chromium, tungsten and vanadium (e.g. M7).
• medical devices that may be lubricated using the PPE-based coating include articulating implantable devices and instruments, including, but not limited to, distractors and adjustable spacers, and softer metallic devices, such as bending templates.
• the polymeric coatings are configured to result in reduced corrosion in certain areas of the instruments relative to other areas.
• some areas of the instrument may be provided with coating materials, while others are not.
• coating materials may be provided which provide differing corrosion protection, for example due to a difference in the composition of the material making up the coating, due to a difference in the thickness of the coating material, and so forth.
• the coating composition and/ or thickness may change abruptly (e.g., in a stepwise fashion) and/ or gradually along the surface of the instrument.
• the PPE-based polymeric coating of the disclosed embodiments may be formed using any of a variety of techniques depending upon the polymer or polymers making up the coatings, including, for example, physical vapor deposition, chemical vapor deposition, electrochemical deposition, layer-by- layer techniques, and coating techniques based on the application of liquid polymer compositions, examples of which include polymer melts, polymer solutions, and curable polymer systems, among other techniques.
• the polymeric coating may be formed using dip-coating, spray coating, web-coating or spin coating.
• the coating may be applied before or after sterilization of the coated instrument and may prevent packaging material from sticking to the instrument.
• the specific polyphenyl ether preservative utilized in the Examples was SANTOTUBE® OS-124 High-Temperature Radiation-resistant Base Fluid, which is a 5-ring polyphenyl ether with exceptionally low volatility and resistance to degradation from heat, oxygen, radiation and chemical attack.
• the hard metal alloy tested in the Examples is M2 steel which contains tungsten and does not contain cobalt.
• polyphenyl ether is as directed in DMR Operating Procedure G01.05.01 Manual Cleaning of Cutters with the exception that instead of the HT-1640-00 oil, the polyphenyl ether SANTOTUBE® OS-124 High-temperature Radiation-resistant Base Fluid is used.
• Cytotoxicity was determined using the MEM Elution subjective scoring method (Grade 0-4) with results reported at 24, 48, and 72 hours post-24-hour extraction. A passing score is Grade 0, Grade 1 or Grade 2. Results of the cytotoxicity study with the above test samples packaged in different packaging are shown in Table 3: [0044] Table 3
• An intracutaneous irritation test was conducted to determine if PPE would leach or be extracted from a test sample and cause local irritation in the dermal tissues of albino rabbits.
• the test sample was diluted at a 1:1 ratio using sesame oil.
• Each animal was weighed and the weight recorded prior to test injection. The fur of the animals was clipped on both sides of the spinal column to expose a sufficient sized area for injection.
• test article and a vehicle control were injected into three rabbits. Each rabbit received five sequential 0.2 mL intracutaneous injections of the test article extract on the right side of the vertebral column and similarly the control vehicle on the left side.
• a test was conducted to evaluate the allergenic potential or sensitizing capacity of a test article containing PPE.
• the test was used as a procedure for the screening of contact allergens in guinea pigs and extrapolating the results to humans.
• mice were treated by the intrap eritoneal route to screen the test article solutions for potential toxic effects as a result of a single-dose systemic injection.
• mice were injected systemically with the test article solution or control sesame oil (SO). The animals were observed for signs of toxicity immediately after injection and at 4, 24, 48 and 72 hours post-injection. The requirements of the test were met if none of the animals treated with the test article had a significantly greater adverse reaction than the animals treated with a vehicle control.
• SO sesame oil
• Molecular stability was determined by observing for changes in the infrared spectra of the neat, non-sterilized and sterilized samples using FTIR-ATR methods.
• the PPE preservative was applied to the internal reflecting element (IRE) directly and the spectrum measured in absorbance mode between 4000 cm 4 and 600 cm 4 in 1 cm 1 increments and 64 co-added scans.
• the butterfly bar was pressed against the IRE and the spectrum obtained using the same wave number range as for the neat sample.
• test devices listed in Tables 5-7 were placed into packaging material and stored under ambient conditions for two weeks (14 days) and then observed for the presence of visible corrosion. If corrosion was observed on the unpreserved samples, then the test was considered completed. Observation of the non-sterile and sterile test devices stored under the same conditions was performed and the presence of visible corrosion reported.
• samples that were cleaned, preserved and packaged by Millstone Medical Outsourcing was implemented as part of the overall evaluation.
• the samples were non-sterile samples.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Epidemiology (AREA)
• Chemical & Material Sciences (AREA)
• Inorganic Chemistry (AREA)
• Transplantation (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Medicinal Chemistry (AREA)
• Dermatology (AREA)
• Surgery (AREA)
• Engineering & Computer Science (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Molecular Biology (AREA)
• Materials For Medical Uses (AREA)
• Prostheses (AREA)
• Surgical Instruments (AREA)

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• 2019
  • 2019-06-05 CN CN201980038872.8A patent/CN112261957A/zh active Pending
  • 2019-06-05 JP JP2020568707A patent/JP7408583B2/ja active Active
  • 2019-06-05 EP EP19744845.9A patent/EP3813898A1/en active Pending
  • 2019-06-05 CA CA3103379A patent/CA3103379A1/en active Pending
  • 2019-06-05 WO PCT/IB2019/054688 patent/WO2019239257A1/en unknown
  • 2019-06-05 BR BR112020025239-5A patent/BR112020025239A2/pt not_active Application Discontinuation
  • 2019-06-05 AU AU2019285470A patent/AU2019285470A1/en not_active Abandoned

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