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WO1999036193A1 - Procede et appareil de formation d'un revetement antiadhesif amorphe et conducteur - Google Patents

Procede et appareil de formation d'un revetement antiadhesif amorphe et conducteur Download PDF

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Publication number
WO1999036193A1
WO1999036193A1 PCT/US1998/008917 US9808917W WO9936193A1 WO 1999036193 A1 WO1999036193 A1 WO 1999036193A1 US 9808917 W US9808917 W US 9808917W WO 9936193 A1 WO9936193 A1 WO 9936193A1
Authority
WO
WIPO (PCT)
Prior art keywords
ceramic coating
coating
wear
compatible
method further
Prior art date
Application number
PCT/US1998/008917
Other languages
English (en)
Inventor
Kumar B. Ajit
Khanwilkar Pratap
B. Olsen Don
Original Assignee
Medquest Products, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Medquest Products, Inc. filed Critical Medquest Products, Inc.
Priority to KR1020007007877A priority Critical patent/KR20010040354A/ko
Priority to EP98944430A priority patent/EP1049544A4/fr
Priority to AU91968/98A priority patent/AU751322B2/en
Priority to CA002318266A priority patent/CA2318266A1/fr
Priority to JP2000539946A priority patent/JP2002509190A/ja
Publication of WO1999036193A1 publication Critical patent/WO1999036193A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C30/00—Coating with metallic material characterised only by the composition of the metallic material, i.e. not characterised by the coating process
    • 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
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • 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
    • A61L29/10—Inorganic materials
    • A61L29/106—Inorganic materials other than carbon
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26B—HAND-HELD CUTTING TOOLS NOT OTHERWISE PROVIDED FOR
    • B26B21/00—Razors of the open or knife type; Safety razors or other shaving implements of the planing type; Hair-trimming devices involving a razor-blade; Equipment therefor
    • B26B21/54—Razor-blades
    • B26B21/58—Razor-blades characterised by the material
    • B26B21/60—Razor-blades characterised by the material by the coating material
    • C—CHEMISTRY; METALLURGY
    • C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
    • C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
    • C23C14/00—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material
    • C23C14/06—Coating by vacuum evaporation, by sputtering or by ion implantation of the coating forming material characterised by the coating material
    • C23C14/0641—Nitrides

Definitions

  • This invention pertains to a method for providing a conductive, non-stick coating at or near room- temperature to many materials which can benefit therefrom. More specifically, the present invention pertains to a method and apparatus for applying the conductive, non-stick coating to different materials, as well as presenting various embodiments which can take advantage of the coating's properties including bio-compatibility, flexibility, radio-opacity, diffusion resistance, wear and corrosion resistance, hardness, ability to be hydrophobic or hydrophilic, adherence to multiple materials, sterilizability, and chemical inertness and stability.
  • the present invention was originally developed as a result to improve electrosurgical instruments used in cauterization and other medical procedures, as well as to provide a bio-compatible coating for long-term implantable blood pumps.
  • prior U.S. patents have been issued for various electrosurgical blades which apply a non-stick coating to a cutting edge thereof. These blades typically suffered from small openings in the non-stick coating which were sometimes intentionally allowed to form in order to ensure electrical conductivity along the cutting edge. Exposing the metallic surface of the blade disadvantageously resulted in charred tissue sticking to these areas. The result was that the blade quickly became non-conductive and consequently unusable.
  • Blanch was granted U.S. Patent No.
  • Teflon (TM) The non-stick coating of the ⁇ 807 patent is also specifically described as Teflon (TM) .
  • Teflon (TM) The nature of Teflon (TM) is such that it requires a high current to be used in cutting and cauterization. This is because electrical current must pass through the Teflon (TM) to the tissue. However, this constant passage of current eventually breaks down the Teflon (TM) , leaving small holes or other imperfections in the Teflon (TM) coating. Charred tissue then begins to adhere to the exposed metal beneath the Teflon (TM) coating. Furthermore, electrical current will no longer be uniform across the blade because the current will tend to concentrate at locations where the metal is exposed.
  • Teflon Teflon
  • stents can cause infection and thrombosis, and have lubricity problems. Stents also clot up after some period of time, and the body can form scar tissue around the stent. A bio-compatible coating having greater lubricity and which is flexible enough to expand with the stent when deployed. Stents also tend to stick to the catheter that is used to insert them.
  • Catheters also have lubricity problems. They can be difficult to insert, especially when they are long. They are also hard to extract because they can become stuck.
  • Present coatings that are used on catheters usually do not remain on the catheter, and either have the property of bio-compatibility or lubricity, but not both.
  • Nonbio-compatible coatings are usually inflexible and cannot be applied to flexing plastics such as catheters . Friction during insertion also removes biological and polymeric coatings, and they also wash off when exposed to flowing fluids, such as blood.
  • the tip of the catheter and the insertions site also tend to be the site of blood clots.
  • radio-opaque metal band to denote the catheter position using X-ray imaging.
  • This band disadvantageously causes crimping of the catheter.
  • the metal band is also known to slip along the length of the catheter, thereby causing false readings of the catheter position in the body.
  • the metal band providing radio-opacity is also typically large. This can result in insertion and extraction problems for the catheter.
  • the metal band can also irritate and damage the inner surface of the vessel through which the catheter is inserted.
  • Guide wires used to install catheters also have problems of lubricity because they provide a frictional surface which resists entry into and passage through tissue.
  • the installation of a shunt is a painful process because of the friction of the tissue.
  • state of the art shunts are also limited in their useful lifespan because they tend to have bio- compatibility problems.
  • Silicone-based medical devices such as inhaler seals, laryngechtomy prostheses, and nasal tampons have several major problems.
  • the solid silicone is sticky and rubbery, and thus these devices are hard to insert and withdraw due to lubricity problems. Some of these devices are also subject to infection and thrombosis .
  • Trocars are also medical devices which would benefit from a bio-compatible coating having a high degree of lubricity. Trocars are used to introduce larger-sized implants and/or surgical tools, especially for minimally invasive surgery. Like needles, they have friction problems and can cause damage at the site of insertion.
  • Soft tissue implants such as breast, penile, and testicular implants, as well as devices such as pulsatile mechanical blood pumps suffer from diffusion problems.
  • breast implants huge liability has been incurred from silicone leaking out and causing potential systemic harm to the body.
  • blood pumps their pumping gases and fluids leak out, with potentially harmful side effects, as well as inconvenience caused by additional implanted hardware to replace lost fluids and added cost and inconvenience to the patient who has to make repeated trips to the hospital.
  • body fluids leak in, causing the corrosion of components which eventually cause device failure.
  • Drug containers also have problems of corrosion and chemical reactions, especially with the newer and more potent drugs, as well as of diffusion of drugs through the container, including the rubber stoppers used as the caps of some drug containers. It is also mentioned that syringe components such as plungers often get stuck or caught while pulling in fluid. Often, excessive force is used while expelling fluids. These situations all combine to reduce patient safety because of increased risk of injury. These are also similar problems to contraceptive and OB/Gyn devices which have problems with infection, thrombosis, tissue growth and friction causing irritation and subsequent trauma to surrounding tissue. Likewise, grafts and cuffs such as vascular grafts and varicose vein cuffs have problems with infection and thrombosis.
  • Electrodes especially those used for esophageal pacing, fetal monitoring, spinal epidural, and for ablation have problems of assuring electrical conductivity to the skin.
  • a different problem is raised by electro medical devices which suffer from failures caused by inadequate electro-magnetic interference (EMI) shielding. Often, this failure relates to the use of plastic and other non-metallic parts in the electrical assembly that cannot be easily shielded.
  • EMI electro-magnetic interference
  • Non-medical devices have other problems as well that could be solved by a coating as described above.
  • magnets have hydrogen embrittlement and subsequent degradation problems . These problems are acute in the new high-strength rare-earth magnets (e.g. Neodymium Iron Boron). This happens because hydrogen diffuses into the material and causes failure. Hydrogen embrittlement is also a problem in the aircraft industry with titanium and other structural materials .
  • Disk drives might also benefit from the present invention. Specifically, EMI problems and friction problems could be eliminated with a coating like the present invention.
  • Integrated circuits suffer from problems of moisture and ion ingress which can result in failure of the circuit.
  • Another problem is the diffusion of gold used in the gold/titanium ohmic contacts. Magnetic media could also substantially benefit from such a coating. The degradation over time is often the result of high humidity conditions and physical wear of the material from contact with a read or write head.
  • Fiber optic conduits could also benefit because they suffer from the diffusion of gases and other fluids which causes their optical properties to degrade.
  • Superconducting and photo diodes also suffer from diffusion barrier problems . Fluid valves and solenoids also having sticking problems. Their moving parts tend to stick to their static components, resulting in intermittent or terminal component failure.
  • a coating which has the characteristics of being conductive, having a high degree of lubricity, providing bio-compatibility, flexibility, radio-opacity, diffusion resistance, wear and corrosion resistance, hardness, ability to be hydrophobic or hydrophilic, adherence to multiple materials, sterilizability, and chemical inertness and stability.
  • RFID radio frequency interference
  • the present invention provides in a preferred embodiment a ceramic coating which is conductive, flexible and provides a surface which functions as if it were lubricated.
  • the manufacturing process produces a coating of titanium nitride on a surface of a desired substrate material.
  • the coating is amorphous, enabling the substrate to bend if desired.
  • One aspect of the invention is the considerably improved durability of the ceramic coating. Unlike other coatings, the present invention does not burn away, flake or scrape off after repeated exposure to heat and abrasion from sharp edges .
  • FIG. 1 is a schematic diagram of a sputtering chamber used in the direct sputtering manufacturing process of the present invention.
  • Figure 2 is a diagram of the components of a pulsatile blood pump, showing where diffusion of gases and liquids occurs which leads to failure or reduced performance of the pump, and possible health consequences to the patient .
  • Figure 3 is a cross-sectional diagram of the presently preferred embodiment for a diffusion barrier in medical devices .
  • the present invention is comprised of a method of applying the conductive, non-stick coating, at or near room temperature, as well as the particular materials which can benefit from the coating in their normal use.
  • devices, instruments and various apparati can take advantage of being coated. These devices include those which can benefit from a conductive wear resistant coating which can also provide the benefits of being conductive and amorphous (and thus flexible) .
  • the conductive, non-stick coating is a ceramic coating.
  • the ceramic coating is composed of titanium nitride (TiN) which is applied over the substrate by any appropriate method, such as those to be discussed later.
  • the ceramic coating of the present invention can be applied in relatively thin layers to substrates, typically on the order of Angstroms .
  • the ceramic coating composed of TiN. It should also be mentioned that while the preferred embodiment uses TiN as the ceramic coating, there are other ceramics from the family of ceramics known as transition metal nitrides which might be used in the present invention. These ceramic coating materials include titanium nitride, among others. These materials are classified in terms of properties of hardness, corrosion resistance, color and high spectral reflectance (smoothness) . What is important to the preferred embodiment of the present invention is that the material selected for the ceramic coating 104 have the desirable characteristics of TiN.
  • the coating (a) be conductive, (b) act amorphous after application to the electrosurgical instrument, and (c) have a high degree of lubricity to thereby flow smoothly through tissue being cut/cauterized.
  • TiN can be used alone or in combination with other materials having desirable characteristics. These other materials might also include other conductive (transition metal nitrides) or non-conductive ceramics.
  • Titanium Nitride is a ceramic whose crystalline form is well known for its advantageous properties of hardness, wear resistance, inertness, lubricity, biocompatibility, diffusion resistance, corrosion resistance and thermal stability in such applications where a low friction interface is needed to protect moving parts from wear. While it is the properties of electrical as well as thermal conductivity jointly with lubricity which make it attractive as a suitable coating for an electrosurgical blade, it is often the case that only one or two of the characteristics of the coating are used by the other embodiments of the present invention.
  • the preferred process of applying the coating to different substrates is the process of sputtering.
  • the TiN can be applied using sputtering at room or near-room temperatures, significantly simplifying the manufacturing process.
  • TiN can also be applied with high dimensional accuracy to obtain an even coating thickness along all surfaces .
  • TiN exhibits a very high load carrying capacity and toughness.
  • TiN also has excellent adhesion qualities so that it does not spall, even under plastic deformation of the surface. The high toughness and excellent adhesion properties are due to a metallurgical bonding between some substrates and the TiN coating.
  • the TiN coating is the process of sputtering.
  • the TiN can be applied using sputtering at room or near-room temperatures, significantly simplifying the manufacturing process.
  • TiN can also be applied with high dimensional accuracy to obtain an even coating thickness along all surfaces .
  • TiN coating bonds well with other metals such as steel and stainless steel.
  • TiN advantageously has high hardness and low friction coefficients (referred to as lubricity) .
  • This property of lubricity enables the conductive, non-stick coating to glide through tissue for extended periods of time between cleaning.
  • Teflon (TM) coatings TiN will not burn off or wear away quickly from repeated use to leave a substrate exposed.
  • the ceramic TiN either has no wear, or wears substantially less than, for example, the Teflon (TM) coating used in the prior art because Teflon (TM) burns away, and peels off the substrate. Consequently, the present invention has a longer useful lifespan.
  • the TiN ceramic coating of the present invention also has great flexibility.
  • the coating process allows the TiN to be applied on surfaces which are not normally able to receive such a coating. This includes surface materials such as plastics, magnets, semiconductors, and other heat- sensitive materials including aluminum.
  • the present invention also has a much stronger bond between a base metal substrate and its ceramic coating. This bond extends down to the molecular level . More specifically, there is a metallurgical bonding between a metallic substrate and the TiN coating. What is created is defined as an interfacial nanometer layer consisting of both the base metal substrate and the TiN ceramic coating. This interfacial zone is created in the first stage of the coating process when TiN is sputtered onto the base metal substrate.
  • the TiN ceramic coating can be referred to as an amorphous bond, having no crystalline structure subject to fracturing.
  • the amorphous TiN ceramic coating can therefore flex integrally with the base metal substrate to which it is attached.
  • Items which can benefit from the ceramic coating of the present invention include scissors, knives, drill bits, reamers, saw blades, pliers, end mills, wire cutters, precision coining dies, rollers, pins, screws, bore gauges, stamp metal forming tools, extrusion dies, spool lips for spinning reels, counter bores, taps broaches, gear cutters, bearings bushings, gears, splines, actuators, push rods, cams, cam shafts, hobs, punches, valve stems, router bits, engine parts, blanking dies, resistance welding electrodes, scrapers, gouges, countersinks, counterbores , silicon wafers and chips, pump plungers, embroidery needles,
  • VLSI semiconductors compressor blades/vanes, jewelry, door hardware, writing instruments, eyeglass frames, shafts and seals, marine hardware, plumbing fixtures, slitters, aerospace components, plastic molds, dental instruments and devices, food processing equipment, key duplicators, forming dies, cutting tools, granulator blades, powdered metal dies, seaming rolls, burnishers, engravers, minting devices, razor blades, toy components, umbrellas, optical fibers, integrated circuits, video/audio heads, video/audio tapes, computer floppy disks, packaging, solar cells, kitchen utensils, window panes, golf clubs, bicycle components, reflectors, spark plugs, lamp shades, key chains, piston rings, fluid pumps, super conducting thin films, photo diodes, light emitting diodes, diode lasers, electrodes, electrochemical cells, thermolytic coolers, nuclear fuel pellets, magnetic recording media and heads, fluid valves, solenoids, disk drives, circuits to provide protection from EMI, circuit boards, belts,
  • the ceramic coating includes biocompatibility, a continuous coating, a smooth coating, a non-stick coating (reduces friction and eliminates galling and seizing) , it is aesthetically appealing, corrosion resistant, wear resistant, fatigue resistant, sterilizable, generally radio opaque, applicable to flexible surfaces, adheres to a variety of surfaces which comprises different materials including composites, is applicable as a room-temperature process, does not introduce residual stresses, is conductive, is conformal and thin, and can act as a diffusion barrier.
  • the potential benefits are increased head life and longevity of the media, improved quality of audio or video reproduction, less wear on the media, and the ability to coat plastics and thereby replace metal heads .
  • the coating can be applied to aluminum, while Teflon (TM) cannot, it will resist scratching and chipping better, it will result in a pot or pan with a longer life, it is non-stick, and metal spoons, spatulas and other metal utensils can be used without fear of damaging the coating.
  • plastic gears the potential benefits are improved wear, less weight, lower costs, maintaining of dimensional accuracy, and longer life.
  • razor blades there should be less skin irritation, lower costs of producing blades, improved quality, and a large marketing advantage.
  • the coating should provide longer life, reduced fouling and improved performance, particularly in the two cycle oil-mix variety.
  • the TiN ceramic coating of the present invention provides many unique advantages over the prior art.
  • the TiN ceramic coating does not significantly wear or burn off, thereby providing improved reliability and durability, and not evolving by-product gases.
  • the TiN ceramic coating can also be repeatedly cleaned so that the device which is coated can be reused many times.
  • many different sterilization techniques can be used without damaging the TiN coating.
  • the substrate can be stainless steel, other materials can also be used. These other materials might also be conductive metals such as titanium, but can also include non- conductive materials such as plastics .
  • the TiN ceramic coating is applied to a stainless steel blade using a room temperature direct sputtering process .
  • Sputtering is a room or relatively low temperature process by which a controlled thin film of Titanium Nitride is uniformly deposited on the stainless steel blade or any other substrate.
  • the sputtering process itself is relatively simple, and has numerous advantages for the present invention.
  • the sputtering process does not change the characteristics of the base metal substrate or the TiN ceramic coating.
  • the other advantages become obvious with an examination of the sputtering process .
  • the first form of sputtering is known as direct sputtering. This means that the sputtering is done directly from a TiN source.
  • TiN sources are available commercially, and pure TiN can be coated onto a base metal substrate using radio frequency sources in a non-reactive atmosphere.
  • Another method of applying TiN to a base metal substrate is through the process of reactive sputtering.
  • the reactive atmosphere must be composed of nitrogen.
  • the titanium reacts with the nitrogen atmosphere to form titanium nitride.
  • the TiN then coats the surface of the stainless steel.
  • the process of both direct and reactive sputtering involves much of the same equipment as shown in FIG. 1.
  • the sputtering takes place in a stainless steel chamber 10.
  • the stainless steel chamber 10 has dimensions of approximately 18 inches in diameter and 12 inches in height.
  • the actual sputtering function is accomplished by sputtering guns 12 which are generally located at the top of the stainless steel chamber 10.
  • the sputtering guns 12 are capable of movement in both the horizontal and vertical directions as desired.
  • the sputtering system described above is accomplished using standard equipment readily available for manufacturing.
  • An example of the direct sputtering process is as follows.
  • the stainless steel chamber 10 is evacuated of ambient air through evacuation port 14.
  • An inert gas such as argon is then fed into the stainless steel chamber 10 through a gas port 16.
  • the argon gas is ionized using the cathode 18 and the anode 20 to generate an ion flux 22 which strikes the Titanium Nitride 24.
  • the impact of the ion flux 22 will eject TiN sputtered flux 26 which travels and adheres to the base substrate 30. It is important to note that there are other sputtering processes well known to those skilled in the art which are also appropriate for applying the TiN ceramic coating 26.
  • the sputtering time is generally 1 to 1.5 hours to generate a TiN ceramic coating 26 on the base metal substrate 30 which is approximately 0.5 microns thick.
  • the sputtering process applies the TiN ceramic coating 26 according to a linear function, so the application time is easily adjusted accordingly to obtain the desired thickness.
  • the 0.5 micrometer thick TiN coating thus corresponds to a TiN deposition rate of approximately 1 angstrom thickness being added every second.
  • sputtering is a momentum transfer process. It is a process wherein constituent atoms of the material are ejected from surface of a target because of momentum exchange associated with bombardment by energetic particles.
  • the bombarding species are generally ions of heavy inert gas, usually argon.
  • Sputtering may be used for both surface etching and/or coating.
  • the flux of sputtered atoms that may collide repeatedly with the working gas atoms before reaching the substrate where they condense to form a coating of the target material.
  • a key difference between coating on metals and coating on plastics is that plasma is used to modify and/or pretreat the surface of the plastic to a greater extent on plastics than on metals.
  • a plasma treatment can be given in a separate chamber or by using the same sputtering machine used for coating at lower energy levels at which plasma forms but no or minimal sputtering occurs. This pre-treatment helps the coating adhere better to the plastic substrate.
  • the plastic surface is in contact with the plasma, and plasma ion bombardment on the surface modifies the plastic surface by plasma etching which is more conducive to receiving the target atoms.
  • plasma ion bombardment on the surface modifies the plastic surface by plasma etching which is more conducive to receiving the target atoms.
  • This promotes a dense, fine-grained amorphous structure on the surface depending on the process conditions such as pressure and power.
  • the bombardment effects will give the target atoms enough energy to get into the surface layers of the plastic, thereby giving excellent bonding of the coating with the substrate.
  • the flux of sputtered material leaving the target will be identical in composition to the target.
  • the quality of the coating depends on the sputter emission directions, the gas phase transport, and the substrate-sticking coefficient of the constituents. Because the coating target material transfers to vapor phase by a mechanical process (momentum transfer) rather than by a chemical or thermal process, the heating of the substrate can be controlled by carefully adjusting the conditions (keeping sputtering energy levels and thus temperatures low) . This adjustment makes it possible to coat plastic surfaces at room or near room temperature without damaging the substrate. While the presently preferred method of application of the ceramic to the substrate is through sputtering, it should be apparent that there are other methods . These include such methods as CVD and plasma deposition. Therefore, the application method of sputtering should not be considered limiting in the present invention.
  • TiN also differs from other state of the art coatings for base metals in that it does not evolve dangerous gases. When heated, TiN does not evolve any gases .
  • mechanical devices which can benefit from the present invention include blood pumps such as Ventricular Assist Devices, Artificial Hearts, Intra- Aortic Balloon Pumps and Impellers.
  • the coating is applied to most plastic, metallic and ceramic components including magnets which can be coated at the room or near room temperature process to thereby not affect the magnetic properties.
  • the coating provides such advantageous features as bio- compatibility including non-toxicity, even when the underlying material might not be bio-compatible.
  • the coating can also function as corrosion resistance, and even as a diffusion barrier.
  • the coating of the present invention be applied to the blood-contacting surfaces, but also to the exterior of implanted device.
  • Such devices include balloons such as epitaxis, catheter, occluder, intra-aortic balloons and angioplasty balloons.
  • the coating can also be disposed on diaphragms, volume displacement chambers, and associated fluid paths in plastic tubes.
  • the coating can also be used on bearings and bearing components .
  • These components include balls, pivots, and inner and outer races used in actuators for medical devices. The result is a reduction in wear and thus increased lifespan of the medical devices.
  • Soft-tissue implants include intravaginal and colostomy pouches, breast implants, penile and testicular implants.
  • Valves of the type used in hearts can also be improved by the coating disposed on disks and struts .
  • Existing stents made from metal, ceramic and plastic and used for an annulplasty ring can be coated to provide the desired flexible and bio-compatible outer covering .
  • Shunts such as a dialysis shunt, an A-V shunt, a central nervous system shunt, an endolymphatic shunt tube, a peritoneal shunt and a hydrocephalys shunt can also be coated.
  • Silicone-based medical devices including inhaler seals, valves for laryngechtomy prostheses, nasal tampons, and tubes can also be coated.
  • the present invention can also serve to coat a plastic sheath covering current-carrying loads, as well as the leads themselves, connectors, feedthroughs for any implanted, electrically powered device such as a pacemaker, defibrillator , cardioverter , bipotential electrodes and leads, neural stimulators such as a cerebellar, brain, cranial, nerve and spinal cord device.
  • a pacemaker defibrillator
  • cardioverter cardioverter
  • bipotential electrodes and leads a neuro stimulators
  • neural stimulators such as a cerebellar, brain, cranial, nerve and spinal cord device.
  • the implanted devices can also be optical or cochlear in nature.
  • Contraceptive and Ob/Gyn devices include a plug prostheses, tubal occlusion devices (band, clip, insert and valve), urethal devices such as a stent, dilator and a catheter, IUDs and diaphragm.
  • Other devices include an angiographic and other guide wire.
  • Sensors and transducers which are of the implantable variety as well as the non-implantable short-term variety can be coated.
  • the coating itself can be used as sensing material which detects changes in its property such as conductivity as a function of the thing being measured.
  • Occluders include those used in patent ductus arteriosus .
  • a tracheotomy tube can also be coated.
  • hermetically sealed cans and other enclosures having a plastic-based substrate can be coated, including those used to encase electronics of any type, for actuators, sensors and fluids.
  • Surgical instruments and devices can also be coated.
  • Such devices include catheters of all types, needles, trocars, feeding/breathing tubes, transfusion tubes, clips, surgical staples, electrosurgical instruments, pumps, as well as knives, scalpels, scissors, clamps, coagulators, dilators, retractors, examination gloves, non-absorbable sutures and ligatures, microtomes, surgical meshes, tonsil dissectors, and vascular clamps, stereotaxis instruments and accessories, and heat exchangers.
  • Measuring and analytical devices include blood measuring and evaluating devices, blood collection systems, containers for blood and other sensitive fluids, linings, tubes and blood-contacting surfaces of laboratory instruments, and coatings for leads used in such things as an EEG, ECG, etc.
  • syringes Other devices that can be coated are syringes, plungers, intra ocular lenses, drug containers and packaging.
  • diffusion barriers One particularly important medical application of the present invention is in diffusion barriers .
  • Many implantable devices such as a blood pump, as well as soft-tissue implants (breast, penile and testicular) have diffusion barriers containing fluids.
  • the diffusion barriers are supposed to prevent the passage of working fluids (such as a lubricating oil) from within the medical device to the body.
  • body fluids blood
  • diffusion barriers are soft membranes which are disadvantageously permeable to gases and fluids.
  • the present invention functions as a diffusion barrier to prevent or at least reduce the passage of gases and fluids through the permeable membranes.
  • FIG. 2 is a blood pump 40.
  • the blood pump 40 has a pumping chamber 42 in which is disposed a polyurethane membrane 44 which functions as a diaphragm. On one side of the membrane 44 is blood 46. On the other side of the membrane 44 is a working fluid 48 of the blood pump 40.
  • the pumping chamber 42 is coupled via an energy converter 50 to a volume displacement chamber 52. Within the volume displacement chamber 52 is the working fluid 48 of the blood pump 40.
  • the arrows 54 indicate that diffusion occurs through the membrane 44 between the blood 46 and the working fluid 48 in the pumping chamber 42, and between the working fluid 48 and tissues 56 which surround the volume displacement chamber 52.
  • the working fluid 48 of the blood pump 40 is typically some of type of lubricating oil such as silicone oil. Obviously, it is desirable to prevent blood 46 and working fluid 48 from passing through the flexible membrane 44.
  • pulsatile pumps accept diffusion of blood and working fluids, and simply try to treat the symptoms of the problem.
  • the pulsatile pumps are often provided with a priming port for receiving gas or working fluids .
  • Allowing diffusion is detrimental to the pulsatile pumps for several reasons.
  • the membranes used in these chambers also allow body fluids into the device. These body fluids contain ions and moisture which cause corrosion and wear of the blood pump's energy converter, thus leading to eventual failure of the pump due to short-circuiting or corrosion.
  • Previous attempts to reduce permeability of the membrane have failed to stop diffusion. For example, multiple membrane layers or different membrane materials have been tried. Unfortunately, none of these attempts have succeeded.
  • the present invention advantageously reduces diffusion of working fluids and blood through the membrane by coating the membrane with a flexible, bio- compatible, corrosion resistant ceramic coating.
  • FIG 3 is a cross-sectional profile view of the presently preferred embodiment of a membrane 60 to be used in a pumping mechanism.
  • a layer of the ceramic coating 62 is disposed between two layers 64 and 66 of the membranes.
  • polyurethane is used for the membranes 64 and 66.
  • the thickness of the ceramic coating 62 has experimentally been determined to be within the range of approximately 5000 to 10,000 angstroms.
  • the ceramic coating 62 is deposited on one of the polyurethane membranes 64 or 66 after vacuum forming or solution casting. During sputtering, the polyurethane surface is energized by the argon plasma. Accordingly, the ions of the ceramic coating material will actively bond with the surface, thus creating a diffusion layer which is amorphous.
  • the second layer of polyurethane will form an active surface while heated during vacuum forming.
  • the polymer will be in a liquid phase, enabling the polyurethane to enter surface micro-irregularities of the ceramic coating.
  • amorphous Titanium Nitride is insert, fatigue resistance, bio-compatible, corrosion resistant and lightweight. Furthermore, TiN is hydrophobic, and thus prevents the diffusion of any liquids through its surface. It is possible to also make the surface hydrophilic by appropriate surface plasma treatments. Diffusion occurs predominantly along grain boundaries . Since the amorphous nature of the TiN coating does not have any grain boundaries, diffusion through the TiN ceramic layer 62 is greatly reduced.
  • gold can also be sputtered.
  • gold is likely to fail due to its low fatigue resistance under continuous flexing and stretching conditions of the membrane in a blood pump.
  • gold is relatively expensive compared to TiN. Silver and copper are corrosive and hence cannot be used in this medical application.
  • Ceramics of the family of TiN can be used as the diffusion barrier. These ceramics include Aluminum Oxide, Titanium Carbide, Silicon Carbide, Silicon Nitride, Boron Nitride and Zirconia.
  • the advantages of these ceramics is that like TiN, they provide an amorphous coating through sputtering, they also inhibit permeability of gases and fluids, they can be deposited at room or near-room temperature, they can be applied to multiple materials to thereby provide a same coating on different parts and materials of the pump, and they are all bio-compatible.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Mechanical Engineering (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Materials Engineering (AREA)
  • Metallurgy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dermatology (AREA)
  • Forests & Forestry (AREA)
  • Medicinal Chemistry (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Laminated Bodies (AREA)
  • Physical Vapour Deposition (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

Cette invention se rapporte à un revêtement antiadhésif conducteur (62), que l'on forme en utilisant un matériau céramique, du type conducteur et flexible, qui forme une surface ayant un pouvoir lubrifiant. Un procédé de fabrication à température ambiante ou à température quasi-ambiante produit un revêtement de nitrure de titane sur un substrat, ce revêtement étant amorphe si le substrat est constitué par un matériau solide, notamment à base de plastics, de composites, de métaux, de matériaux magnétiques et de matériaux céramiques, ce qui permet au substrat de se plier sans endommager le revêtement. Ce revêtement peut également être appliqué sur une grande variété de formes de substrat, comme revêtement épousant ces formes, selon l'application. Ce revêtement est biocompatible et peut être appliquer sur une grande variété de dispositifs médicaux.
PCT/US1998/008917 1998-01-19 1998-07-09 Procede et appareil de formation d'un revetement antiadhesif amorphe et conducteur WO1999036193A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
KR1020007007877A KR20010040354A (ko) 1998-01-19 1998-07-09 전도성, 비정질 비점착성 코팅 제공방법 및 장치
EP98944430A EP1049544A4 (fr) 1998-01-19 1998-07-09 Procede et appareil de formation d'un revetement antiadhesif amorphe et conducteur
AU91968/98A AU751322B2 (en) 1998-01-19 1998-07-09 Method and apparatus for providing a conductive, amorphous non-stick coating
CA002318266A CA2318266A1 (fr) 1998-01-19 1998-07-09 Procede et appareil de formation d'un revetement antiadhesif amorphe et conducteur
JP2000539946A JP2002509190A (ja) 1998-01-19 1998-07-09 伝導性でアモルファスの非粘着性コーティングを提供する方法及び装置

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US7177898P 1998-01-19 1998-01-19
US60/071,778 1998-01-19

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WO1999036193A1 true WO1999036193A1 (fr) 1999-07-22

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PCT/US1998/008917 WO1999036193A1 (fr) 1998-01-19 1998-07-09 Procede et appareil de formation d'un revetement antiadhesif amorphe et conducteur

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EP (1) EP1049544A4 (fr)
JP (1) JP2002509190A (fr)
KR (1) KR20010040354A (fr)
CN (1) CN1310647A (fr)
AU (1) AU751322B2 (fr)
CA (1) CA2318266A1 (fr)
WO (1) WO1999036193A1 (fr)

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WO2004063412A1 (fr) * 2003-01-16 2004-07-29 Daimlerchrysler Ag Composant de moteur
JP2005508728A (ja) * 2001-03-29 2005-04-07 カール − ツァイス − シュティフツング コーティングされたプラスチック物体の製造方法
WO2006096127A1 (fr) * 2005-03-11 2006-09-14 Sandvik Intellectual Property Ab Produit de metal anti-adherant revetu par depot physique en phase vapeur d'un oxyde metallique hydrophobe
EP1685861A3 (fr) * 2005-01-28 2006-09-27 Greatbatch, Inc. Revêtement pour un stent pour la libération de médicaments
WO2008054340A3 (fr) * 2005-08-16 2008-07-24 Honeywell Int Inc Revêtement multicouche résistant à l'érosion pour des turbines à gaz
FR2912659A1 (fr) * 2007-02-21 2008-08-22 Cie Euro Etude Rech Paroscopie Dispositif implantable et procede de fabrication correspondant
US8099174B1 (en) 2004-03-05 2012-01-17 Pacesetter, Inc. Left heart implantable cardiac stimulation system with clot prevention electrode body coating and method
US8170689B2 (en) 2004-03-05 2012-05-01 Pacesetter, Inc. Implantable cardiac defibrillation system with defibrillation electrode entrapment prevention and method
US8565872B2 (en) 2004-07-12 2013-10-22 Medtronic ATS Medical, Inc. Anti-coagulation and demineralization system for conductive medical devices
US8653632B2 (en) 2007-03-28 2014-02-18 Medtronic Ats Medical Inc. System and method for conditioning implantable medical devices
CN103866242A (zh) * 2014-03-20 2014-06-18 常州康鼎医疗器械有限公司 医疗器械物理气相沉积(pvd)表面涂层技术
US8834511B2 (en) 2006-10-23 2014-09-16 GlaxoSmithKline, LLC External nasal dilator and methods of manufacture
US8834514B2 (en) 2006-08-30 2014-09-16 Xennovate Medical Llc Resilient band medical device
WO2015052029A1 (fr) * 2013-10-07 2015-04-16 Koninklijke Philips N.V. Agencement de pistes conductrices souples et procédé de fabrication
US9062384B2 (en) 2012-02-23 2015-06-23 Treadstone Technologies, Inc. Corrosion resistant and electrically conductive surface of metal
US9649499B2 (en) 2007-03-28 2017-05-16 Medtronic ATS Medical, Inc. Method for inhibiting platelet interaction with biomaterial surfaces
US9844667B2 (en) 2006-04-12 2017-12-19 Medtronic Ats Medical Inc. System for conditioning surfaces in vivo
US11560923B2 (en) 2019-06-07 2023-01-24 Schaublin Sa Self-lubricated electrically conductive bushing

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KR100536460B1 (ko) * 2002-12-11 2005-12-14 이호진 지르코니아를 이용한 소결체의 제조방법
JP4620109B2 (ja) * 2004-03-23 2011-01-26 イソフラックス・インコーポレイテッド バイオメディカル装置用の放射線不透過性コーティング
CN102534486A (zh) * 2010-12-29 2012-07-04 鸿富锦精密工业（深圳）有限公司 镀膜件及其制备方法
KR20110027745A (ko) * 2011-02-28 2011-03-16 주식회사 도루코 면도기의 면도날 에지와 면도날 제조방법
CN103469168B (zh) * 2013-08-26 2015-09-30 中国科学院宁波材料技术与工程研究所 一种制备润湿性可控的高光滑高硬TiN薄膜的方法
WO2017130383A1 (fr) * 2016-01-29 2017-08-03 オリンパス株式会社 Instrument de traitement haute fréquence
JPWO2018181335A1 (ja) * 2017-03-28 2019-11-14 ヤマハ発動機株式会社 ゴルフクラブヘッドおよびゴルフクラブ
JP7414529B2 (ja) 2017-06-07 2024-01-16 シファメド・ホールディングス・エルエルシー 血管内流体移動デバイス、システム、および使用方法
CN111556763B (zh) 2017-11-13 2023-09-01 施菲姆德控股有限责任公司 血管内流体运动装置、系统
EP4628147A2 (fr) 2018-02-01 2025-10-08 Shifamed Holdings, LLC Pompes à sang intravasculaires
US12161857B2 (en) 2018-07-31 2024-12-10 Shifamed Holdings, Llc Intravascular blood pumps and methods of use
EP3616800B1 (fr) * 2018-08-31 2022-11-09 BIC Violex Single Member S.A. Amincissement de revêtements de lame de rasoir
EP3860675A4 (fr) 2018-10-05 2022-07-13 Shifamed Holdings, LLC Pompes à sang intravasculaires et procédés d'utilisation
WO2021011473A1 (fr) 2019-07-12 2021-01-21 Shifamed Holdings, Llc Pompes à sang intravasculaires et méthode d'utilisation et procédé de fabrication
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US12102815B2 (en) 2019-09-25 2024-10-01 Shifamed Holdings, Llc Catheter blood pumps and collapsible pump housings
EP4034192A4 (fr) 2019-09-25 2023-11-29 Shifamed Holdings, LLC Dispositifs et systèmes de pompes à sang intravasculaires et leurs procédés d'utilisation et de commande
WO2021062260A1 (fr) 2019-09-25 2021-04-01 Shifamed Holdings, Llc Pompes à sang de cathéter et conduits sanguins pliables
EP4072650A4 (fr) 2019-12-11 2024-01-10 Shifamed Holdings, LLC Pompes à sang d'aorte descendante et de veine cave
CN111785952B (zh) * 2020-01-19 2021-10-29 成都拓米电子装备制造有限公司 一种二次电池负极材料用纳米硅粒子的制造方法
CN119040849A (zh) * 2023-05-29 2024-11-29 中国石油天然气集团有限公司 一种表面涂覆耐磨涂层的电磁纯铁材料及热处理方法

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Cited By (31)

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Publication number Priority date Publication date Assignee Title
JP2005508728A (ja) * 2001-03-29 2005-04-07 カール − ツァイス − シュティフツング コーティングされたプラスチック物体の製造方法
WO2004063412A1 (fr) * 2003-01-16 2004-07-29 Daimlerchrysler Ag Composant de moteur
US8099174B1 (en) 2004-03-05 2012-01-17 Pacesetter, Inc. Left heart implantable cardiac stimulation system with clot prevention electrode body coating and method
US8170689B2 (en) 2004-03-05 2012-05-01 Pacesetter, Inc. Implantable cardiac defibrillation system with defibrillation electrode entrapment prevention and method
US8565872B2 (en) 2004-07-12 2013-10-22 Medtronic ATS Medical, Inc. Anti-coagulation and demineralization system for conductive medical devices
EP1685861A3 (fr) * 2005-01-28 2006-09-27 Greatbatch, Inc. Revêtement pour un stent pour la libération de médicaments
US8367151B2 (en) 2005-01-28 2013-02-05 Greatbatch Ltd. Stent coating for eluting medication
US8048151B2 (en) 2005-01-28 2011-11-01 Greatbatch Ltd. Stent coating for eluting medication
US8057543B2 (en) 2005-01-28 2011-11-15 Greatbatch Ltd. Stent coating for eluting medication
US8066764B2 (en) 2005-01-28 2011-11-29 Greatbatch Ltd. Stent coating for eluting medication
WO2006096127A1 (fr) * 2005-03-11 2006-09-14 Sandvik Intellectual Property Ab Produit de metal anti-adherant revetu par depot physique en phase vapeur d'un oxyde metallique hydrophobe
US7744986B2 (en) 2005-08-16 2010-06-29 Honeywell International Inc. Multilayered erosion resistant coating for gas turbines
WO2008054340A3 (fr) * 2005-08-16 2008-07-24 Honeywell Int Inc Revêtement multicouche résistant à l'érosion pour des turbines à gaz
US10406355B2 (en) 2006-04-12 2019-09-10 Medtronic Vascular, Inc. System for conditioning surfaces in vivo
US9844667B2 (en) 2006-04-12 2017-12-19 Medtronic Ats Medical Inc. System for conditioning surfaces in vivo
US8834514B2 (en) 2006-08-30 2014-09-16 Xennovate Medical Llc Resilient band medical device
US9901479B2 (en) 2006-10-23 2018-02-27 GlaxoSmithKline, LLC External nasal dilator and methods
US8834511B2 (en) 2006-10-23 2014-09-16 GlaxoSmithKline, LLC External nasal dilator and methods of manufacture
FR2912659A1 (fr) * 2007-02-21 2008-08-22 Cie Euro Etude Rech Paroscopie Dispositif implantable et procede de fabrication correspondant
WO2008122713A3 (fr) * 2007-02-21 2009-02-05 Cie Euro Etude Rech Paroscopie Ballon intra-gastrique avec revetement en metal et/ou ceramique et procede de fabrication correspondant
US8653632B2 (en) 2007-03-28 2014-02-18 Medtronic Ats Medical Inc. System and method for conditioning implantable medical devices
US11850335B2 (en) 2007-03-28 2023-12-26 Medtronic ATS Medical, Inc. Method for inhibiting platelet interaction with biomaterial surfaces
US11020515B2 (en) 2007-03-28 2021-06-01 Medtronic ATS Medical, Inc. Method for inhibiting platelet interaction with biomaterial surfaces
US9649499B2 (en) 2007-03-28 2017-05-16 Medtronic ATS Medical, Inc. Method for inhibiting platelet interaction with biomaterial surfaces
US9062384B2 (en) 2012-02-23 2015-06-23 Treadstone Technologies, Inc. Corrosion resistant and electrically conductive surface of metal
US9493883B2 (en) 2012-02-23 2016-11-15 Treadstone Technologies, Inc. Corrosion resistant and electrically conductive surface of metal
RU2678637C2 (ru) * 2013-10-07 2019-01-30 Конинклейке Филипс Н.В. Структура на основе гибких токопроводящих дорожек и способ ее изготовления
US10492701B2 (en) 2013-10-07 2019-12-03 Koninklijke Philips N.V. Flexible conductive track arrangement and manufacturing method
WO2015052029A1 (fr) * 2013-10-07 2015-04-16 Koninklijke Philips N.V. Agencement de pistes conductrices souples et procédé de fabrication
CN103866242A (zh) * 2014-03-20 2014-06-18 常州康鼎医疗器械有限公司 医疗器械物理气相沉积(pvd)表面涂层技术
US11560923B2 (en) 2019-06-07 2023-01-24 Schaublin Sa Self-lubricated electrically conductive bushing

Also Published As

Publication number Publication date
KR20010040354A (ko) 2001-05-15
EP1049544A4 (fr) 2004-08-25
AU9196898A (en) 1999-08-02
AU751322B2 (en) 2002-08-15
EP1049544A1 (fr) 2000-11-08
JP2002509190A (ja) 2002-03-26
CA2318266A1 (fr) 1999-07-22
CN1310647A (zh) 2001-08-29

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