11473 results about "Biocompatibility Testing" patented technology

Devices formed of or including biocompatible polyhydroxyalkanoates are provided with controlled degradation rates, preferably less than one year under physiological conditions. Preferred devices include sutures, suture fasteners, meniscus repair devices, rivets, tacks, staples, screws (including interference screws), bone plates and bone plating systems, surgical mesh, repair patches, slings, cardiovascular patches, orthopedic pins (including bone filling augmentation material), adhesion barriers, stents, guided tissue repair/regeneration devices, articular cartilage repair devices, nerve guides, tendon repair devices, atrial septal defect repair devices, pericardial patches, bulking and filling agents, vein valves, bone marrow scaffolds, meniscus regeneration devices, ligament and tendon grafts, ocular cell implants, spinal fusion cages, skin substitutes, dural substitutes, bone graft substitutes, bone dowels, wound dressings, and hemostats. The polyhydroxyalkanoates can contain additives, be formed of mixtures of monomers or include pendant groups or modifications in their backbones, or can be chemically modified, all to alter the degradation rates. The polyhydroxyalkanoate compositions also provide favorable mechanical properties, biocompatibility, and degradation times within desirable time frames under physiological conditions.

A medical device (10) includes a structure (12) adapted for introduction into a patient, the structure (12) being formed of a preferably non-porous base material (14) having a roughened or textured surface (16). The structure (12) is conveniently configured as a vascular stent with a base material (14) of stainless steel, nitinol or another suitable material. The medical device (10) also includes a layer (18) of a bioactive material posited directly upon the roughened or textured surface (16) of the base material (14) of the structure (12). The surface (16) of the base material (14) is roughened or textured by etching or by abrasion with sodium bicarbonate or another suitable grit. A preferred roughened or textured surface (16) is thought to have a mean surface roughness of about 10 μin. (about 250 nm) and a surface roughness range between about 1 μin. and about 100 μin. (about 25 nm and about 2.5 μm). The particularly preferred use of sodium bicarbonate as the abrasive to provide roughness or texture to the surface (16) of the base material (14) of the structure (12) is additionally advantageous in the low toxicity of the sodium bicarbonate to production workers, the ease of product and waste cleanup, and the biocompatibility of any residual sodium bicarbonate.

Systems and methods are described for implants with composite coatings to promote tissue in-growth and/or on-growth. An implant includes: a substrate; a structured surface formed on at least a portion of the substrate; and a biocompatible coating deposited on at least a fraction of the structured surface. The systems and methods provide advantages in that the implant has good biocompatibility while the biocompatible coating has good strength.

A high strength abrasion resistant surgical suture material with improved tie down characteristics and enhanced tissue remodeling and biocompatibility includes protein polymer fibers blended with synthetic fibers. The suture features a multifilament cover formed of strands of ultra high molecular weight long chain polyethylene braided with polyester, nylon or other nonabsorbable materials, along with fibers of a protein polymer, such as collagen. The cover surrounds a core formed of twisted strands of ultrahigh molecular weight polyethylene. The core also can include collagen fibers. The suture, provided in a #2 size, has the strength of #5 Ethibond, is ideally suited for most orthopedic procedures, and can be attached to a suture anchor or a curved needle. The collagen fiber enhances tissue remodeling into the suture strand, thus improving biocompatibility.

A bone cement comprising an acrylic polymer mixture. The cement is characterized in that it achieves a viscosity of at least 500 Pascal-second within 180 seconds following initiation of mixing of a monomer component and a polymer component and characterized by sufficient biocompatibility to permit in-vivo use.

An intervertebral implant is shaped in the form of a hollow cylinder and has a cover face, a base face, a hollow cylinder wall with an outer lateral area and an inner lateral area, as well as a hollow cylinder central axis. The implant is formed at least 95 percent by volume of a radiolucent material which has a modulus of elasticity of between 1 and 20 GPa. Postsurgical observation is permitted by means of X-rays, and at the same time the implant has a high degree of biocompatibility.

An implantable stimulation electrode for use with an implantable tissue stimulator, especially a pacemaker, a defibrillator, a bone stimulator or a neurostimulator includes a metal base body, optionally one or more intermediate layers disposed on the base body and a coating covering the base body and, optionally, intermediate layers in order to increase tissue compatibility. The coating should prevent tissue irritations after implantation and more particularly increase the stimulus threshold associated therewith, have very high biocompatibility and also has an anti-inflammatory effect. An increase in tissue compatibility is achieved by virtue of the fact that the coating has a polysaccharide layer made of hyaluronic acid and/or hyaluronic acid derivatives.

A wound closure apparatus having a porous pad adapted to be fluidly connected to a vacuum pump. The pad is placed over or within a tissue site, and the vacuum pump may be activated to draw air and exudates from the tissue site. The pad contains multiple pore sizes to prevent granulation tissue from migrating into the pad as reduced pressure treatment is applied. The pad has an outer surface adjacent the wound with pore sizes of a diameter of approximately 100 microns or less to prevent tissue from growing into the pad and is treated for biocompatibility.

There is provided a novel wound dressing material which has biocompatibility and infection controllability as essential properties required for such a material, especially excellent flexibility and water absorption properties, thereby accelerating smooth regeneration of a skin defect without stripping off the regenerating skin while removing the material from the skin. A healing agent is added to the wound dressing material which comprises an amorphous film of a crystallinity below 10% and contains fibroin and sericin as a main component.

The present invention is directed to polymeric materials made of biodegradable, bioabsorbable triblock copolymers and implantable devices (e.g., drug-delivery stents) containing such polymeric materials. The polymeric materials may also contain at least one therapeutic substance. The polymeric materials are formulated so as to improve the mechanical and adhesion properties, degradation, biocompatibility and drug permeability of such materials and, thus, implantable devices formed of such materials.

The invention discloses a method for preparing a medical porous tantalum material. The method comprises the following steps of: mixing a poly ethanol aqueous solution and tantalum powder to obtain slurry, wherein the mass concentration of the poly ethanol aqueous solution is 2 to 8 percent; injecting the slurry into an organic foam by vibrating and pressurizing, wherein the vibrating frequency is 20 to 80 times/min; drying; degreasing; sintering, namely raising temperature to 1,500 to 1,800 DEG C at the speed of 10 to 20 DEG C/min under the vacuum degree of 10<-4> to 10<-3>Pa, preserving heat for 120 to 240 minutes, cooling to 200 to 300 DEG C along with a furnace, raising temperature to 1,500 to 1,800 DEG C at the speed of 10 to 20 DEG C/min again, preserving heat for 180 to 240 minutes, raising temperature to 2,000 to 2,200 DEG C at the speed of 5 to 10 DEG C/min, and preserving heat for 120 to 360 minutes; cooling; and performing thermal treatment, namely raising temperature to 800 to 900 DEG C at the speed of 10 to 20 DEG C/min under the vacuum degree of 10<-4> to 10<-3> Pa, preserving heat for 240 to 480 minutes, cooling to 400 DGE C at the speed of 2 to 5 DGE C/min, preserving heat for 120 to 300 minutes, and cooling to room temperature along with the furnace. The porous tantalum prepared by the method is very suitable to be used for the medical implant material for replacing bearing bone tissues, and biocompatibility and the mechanical property can be guaranteed simultaneously.

A suturable adhesion-preventing membrane has high suture strength, good biocompatibility, decomposition and absorption in a living body, sufficient adhesion-preventing effect, and desirable guided tissue regeneration. The membrane is composed of at least one non-woven fabric layer made of collagen fibers, or a laminated membranous substance consisting of at least one non-woven fabric layer made of collagen fibers and at least one sponge layer made of collagen, and a coating layer of gelatin or hyaluronic acid on the surface or surfaces of the above membrane. Preferably, the membrane comprises one to six compressed cross-linked collagen non-woven fabric layers wherein a layer has a fibers having a fiber diameter of 0.05 mm to 1.0 mm, a bulk density of 5.0×10⁻⁴ to 5 g/cm³ and a thickness of 0.1 mm to 50 mm, and a coating layer containing gelatin or hyaluronic acid and having a thickness of 0.05 mm to 20 mm, wherein the coating layer covers one or both sides or a part or whole of the surface of the membrane.

The present invention relates to a membrane for guided bone tissue regeneration and, more particularly, to a membrane for guided bone tissue regeneration having a structure that silk fibroin nanofibers obtained by removing sericin from silk fibers are formed as a nonwoven, and a manufacturing method thereof. A membrane for guided bone tissue regeneration according to the present invention has a predetermined strength, biocompatibility, and biodegradability, and may maintain a sustained drug release system, when drugs are added in the manufacturing process. Additionally, a membrane for guided bone tissue regeneration according to the present invention may be modified corresponding to the condition of usage, because a thickness of the membrane may be adjusted by controlling fineness of nanofibers, compactness of nanofibers, and pore size of a multiporous structure may be adjusted, in a nonwoven manufacturing process. A nanofibrous membrane for guided bone tissue regeneration according to the present invention is manufactured by freezing rapidly, drying a silk fibroin solution obtained by removing sericin from silk fibers, and by electrospinning after dissolving the dried silk fibroin in an electrospinning solvent. The membrane according to the present invention has excellent adhesion and air permeability, and is thereby effective in regeneration of damaged periodontal tissues.

The invention discloses nano-silver antibacterial hydrogel and a preparation method thereof, wherein the antibacterial hydrogel does not contain a chemical cross-linking agent, a cross-linking sensitizing agent and a cross-linking initiator; the porosity is above 90%; the cross-linking degree is above 50%; by weight, the nano-silver antibacterial hydrogel comprises 3-20% of natural polymer or a derivative thereof, 0-20% of synthetic polymer and 0..005-0.2% of nano-silver; and the nano-silver antibacterial hydrogel is prepared by blending the natural polymer or the derivative thereof, the synthetic polymer, a compound containing silver ions and water and then adopting a radiation cross-linking method. The nano-silver antibacterial hydrogel disclosed by the utility model has good biocompatibility and uniform nano-silver distribution and slow-release capability and is capable of effectively inhibiting bacteria, such as escherichia coli.

An injectable mixture for substituting bone tissue in situ comprises: A) a two-component powder/liquid bone cement which upon mixing forms a self-hardening cement paste; and B) a third component consisting of a liquid which essentially is non-miscible with the cement paste and which is suitable to be washed out after hardening of said mixture in situ, resulting in a porous bone substituting material; and C) an X-ray contrast agent which is an organic substance. The injectable bone substitute material for bone augmentation has adaptable mechanical properties, an optimal radio-opacity without any inorganic X-ray contrast agent and therefore good biocompatibility.

The objective of the present invention is to provide a collagen material that possesses physical properties to an extent that allows suturing while still maintaining the biochemical properties inherently possessed by collagen, and retains its shape for a certain amount of time even after application to the body; its production process; and, a medical material on which it is based, examples of which include a artificial tube for nerve, artificial tube for spinal cord, artificial esophagus, artificial trachea, artificial blood vessel, artificial valve or alternative medical membranes such as artificial endocranium, artificial ligaments, artificial tendons, surgical sutures, surgical prostheses, surgical reinforcement, wound protecting materials, artificial skin and artificial cornea, characterized by filling or having inside a substance having biocompatibility that can be degraded and absorbed in the body into a matrix of a non-woven fabric-like multi-element structure of collagen fibers having ultra-fine fibers of collagen as its basic unit.

The present invention provides a method of fixating a mesh implant to a tissue of a subject comprising attaching said mesh implant to said tissue, covering said mesh implant by an antiadhesive barrier, wherein said antiadhesive barrier is attached to said mesh implant by a biocompatible adhesive.

A vascular stent comprising a drug-eluting outer layer of a porous sputtered columnar metal having each column capped with a biocompatible carbon-containing material is described. This is done by placing the stent over a close-fitting mandrel and rotating the assembly in a sputter flux. The result is a coating that is evenly distributed over the outward-facing side of the stent's wire mesh while preventing the sputtered columnar coating from reaching the inward facing side where a smooth hemocompatible surface is required. The stent is then removed from the mandrel, exposing all surfaces, and finally coated with a layer of carbon such as amorphous carbon or diamond-like carbon. The carbonaceous coating enhances biocompatibility without preventing elutriation of a therapeutic drug provided in the porosity formed between the columnar structures. The result is a stent that is adapted to both the hemodynamic and the immune response requirements of its vascular environment.

The invention provides a method for fabricating an implantable medical device to increase biocompatibility of the device, the method comprising: heat setting a polymer construct, wherein the polymer construct is at a temperature range of from about Tg to about 0.6(Tm−Tg)+Tg such that the set polymer construct comprises a crystalline structure having crystals at a size less than about 2 microns; and fabricating an implantable medical device from the heat set polymer construct.

A hyaluronic acid compound which is a reaction product between hyaluronic acid and a phosphatidyl ethanolamine. This compound has biocompatibility and bio-safety, and can be formed into a hydrogel or molded form having a certain shape. Making use of these properties, it is used to treat a knee joint, prevent the accretion of a tissue after an operation and keep a skin wet.