Abstract: A bone insert is provided that includes a cap having a convex top surface made from a plurality of cap micro struts, an elongated stem made from a plurality of stem micro struts, and a barrier between the cap and the stem. The stem of the bone insert is inserted into a hole formed in a host bone until the barrier is pressed against the exposed bone. The bone implant can be placed against a small focus contact point on the cap. Liquid cement can be injected into a large center hole in the cap and the cement can flow through the fenestrations between all of the cap micro struts as well as the space between the bone implant and the bone. The cement can cure to create a high strength structure that provides a strong bond between the bone implant and the host bone.

Abstract: Nonwoven resorbable pouches that at least partially enclose implantable medical devices and improved methods for producing the implantable medical device pouches are described. The nonwoven pouches may comprise one or more drugs. Implantable medical devices that are placed in the pouches prior to implantation are prevented from migrating from the site of implantation by tissue ingrowth into the pouch. Antibiotics may be incorporated into the pouches to prevent post-operative infections. The pouches may be formed in fewer steps than conventional pouches, and without polymer coatings. Nonwoven pouches can be formed in one step by dry spinning instead of using multiple processing steps. In embodiments, the nonwoven pouches are smoother on the inside than the outside to tightly fit the implantable medical devices internally while encouraging external tissue ingrowth.

Abstract: An intracardiac system has an intracardiac pacemaker and a cover. The cover at least partially surrounds the pacemaker. An inner surface of the cover, which faces the pacemaker, includes an inner layer with bioresorbable material. There are also described methods for implanting and explanting an intracardiac pacemaker.

Abstract: Embodiments of the invention described herein thus provide implants and methods for manufacturing an implant having an outer cortical layer that is porous. The porous outer cortical layer can help encourage tissue ingrowth into the implant. The porous outer cortical layer may be positioned around a core structure this is solid or that has a hollow interior. The core structure may be spherical or any other appropriate shape for a medical implant.

Abstract: An embeddable micro-needle patch for transdermal drug delivery and method of manufacturing the same are disclosed. The embeddable micro-needle patch for transdermal drug delivery comprises a supporting substrate, on which the surface includes a plurality of extruded supporting shafts; a biodegradable carrier, which is formed of biodegradable polymer material and disposed on the supporting shaft; and drugs, which are encapsulated in the biodegradable carrier. When the embeddable micro-needle patch for transdermal drug delivery is attached to the skin for a predetermined time, the biodegradable carrier is separated from the supporting shafts and embedded into the skin, and the biodegradable carrier may swell and then degrade, so as to release the drugs, which are encapsulated in the biodegradable carrier, at a rate of 1%-99% loaded drug per day into the skin. Accordingly, velocity of releasing the drugs may be regulated, so as to sustain the drug efficacy.

Abstract: The present invention relates to a layered fibrous construct for use as a scaffold for repairing or replacing cartilage or cartilage-like tissue, and a process for the production thereof.

Abstract: This invention concerns an in situ biodegradable hydrogel drug delivery system in which the components are assembled in a manner that provides a mechanism for the timed cleavage of a particular amide bond in a covalently linked active agent or of the hydrogel structure.

Abstract: The present disclosure relates to methods of facilitating bone growth. The method may include positioning a device around at least a portion of a bone exhibiting a defect, the device capable of retaining bone segments and micro-structured particles. The method may also include applying micro-structure particles within the device to the defect, wherein each of the micro-structure particles include at least one pore therein. In addition, the method may include aligning at least a portion of the micro-structure particles and applying a polymer to the particles and solidifying the polymer.

Abstract: A holey substrate now is used for constructing a graft product, such as building an auto-graft by 3D printing of living cells. When the autograft built atop the holey substrate is implanted, blood vessels and other patient tissues can grow through the holes.

Abstract: Biodegradable and resorbable polymer pouches are described for use with cardiac rhythm mamagent devices (CRMs) and other implantable medical devices (IMDs), i.e., a pouch, covering, or other receptacle capable of encasing, surrounding and/or holding the CRM or other IMD for the purpose of securing it in position, inhibiting or reducing bacterial growth, providing pain relief and/or inhibiting scarring or fibrosis on or around the CRM or other IMD. Optionally, the biodegradable and resorbable pouches of the invention include one or more drugs in the polymer matrix to provide prophylactic effects and alleviate side effects or complications associated with the surgery or implantation of the CRM or other IMD.

Abstract: A magnesium alloy, implants and method for the production thereof. The magnesium alloy includes 1.5 to 7.0% by weight Zn, 0.5 to 3.5% by weight Al, the remainder being magnesium which contains impurities, which promote electrochemical potential differences and/or the formation of precipitations and/or intermetallic phases, in a total amount of no more than 0.0063% by weight of Fe, Si, Mn, Co, Ni, Cu, Zr, Y, Sc or rare earths having the ordinal numbers 21, 57 to 71 and 89 to 103, Be, Cd, In, Sn and/or Pb as well as P.

Abstract: A medical implant includes a metal composite that contains a cellular nanomatrix having a metallic nanomatrix material and a metal matrix disposed in the cellular nanomatrix, the medical implant being configured to disintegrate in response to contact with a fluid. A method for repairing tissue includes disposing an implant in a patient, the implant including a metal composite which contains: a cellular nanomatrix having a metallic nanomatrix material; and a metal matrix disposed in the cellular nanomatrix; contacting tissue of the patient with the implant, the tissue being in need of repair; and non-operatively removing the implant to repair the tissue.

Abstract: A metal implant for use in a surgical procedure is provided with a surface layer that is integral with the metal substrate, and which incorporates a biocidal material. The surface layer is grown by anodizing at a voltage between 50 and 150 V, and the biocidal material incorporated in it by ion exchange. This produces a significantly harder surface than anodizing at low voltage, and generates pits containing ion-absorbing material.

Abstract: Devices and methods for transplanting cells in a host body are described. The cell comprises a porous scaffold that allows ingrowth of vascular and connective tissues, a plug or plug system configured for placement within the porous scaffold, and a seal configured to enclose a proximal opening in the porous scaffold. The device may further comprise a cell delivery device for delivering cells into the porous scaffold. The method of cell transplantation comprises a two step process. The device is incubated in the host body to form a vascularized collagen matrix around a plug positioned within the porous scaffold. The plug is then retracted from the porous scaffold, and cells are delivered into the vascularized space created within the porous scaffold.

Abstract: Degradable bioprostheses made of collagen-based material having amine-based and ester-based crosslinks are provided, as are methods for their formation and use. Some embodiments of the present invention are directed towards a method of controlling the ratio of amine-based crosslinks to ester-based crosslinks within a collagen-based material to provide a tailorably crosslinked collagen-based material. Some embodiments provide a method of making a degradable bioprosthesis involving controlling crosslinking to afford a degradable bioprosthesis that is partially crosslinked. By controlling the ratio of amine-based to ester-based crosslinks, by controlling the level of crosslinking, or by controlling both of these features, degradable bioprostheses with tailored degradation rates can be synthesized. Some embodiments of degradable bioprostheses have degradation rates that are tailored to allow their use in particular medical applications.

Abstract: Bioactive implant for myocardial regeneration and ventricular chamber support including an elastomeric microporous membrane. The elastomeric microporous membrane being at least one non-degradable polymer and at least one partially degradable polymer. The non-degradable polymer is selected from polyethylacrylate and polyethylacrylate copolymerized with a hydroxyethylacrylate comonomer. The partially degradable polymer is selected from caprolactone 2-(methacryloyloxy)ethyl ester and caprolactone 2-(methacryloyloxy)ethyl ester copolymerized with ethylacrylate. The elastomeric microporous membrane further includes a nanofiber hydrogel, and cells. The bioactive implant, having one or two helical loops, contributes to the restauration of the heart conical shape.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: Improved methods for preparing polyethylene glycol fumarate) are disclosed. Methods for chemically crosslinking or photocross-linking hydrophilic polyethylene glycol fumarate) with hydrophobic polymers such as poly(propylene fumarate) (PPF) and poly(caprolactone fumarate) (PCLF) to form various hydrogels (FIG. 1) with controllable hydrophilicity are also disclosed. The hydrogels are useful in the fabrication of injectable and in-situ hardening scaffolds for application in skeletal reconstruction. An injectable material including the hydrogels may be useful in controlled drug release.

Abstract: The present invention relates to a process for modifying the surface morphology of a medical device. The modified surface has, among other advantageous properties, an improved capacity for sorption or conjugation of a variety of bioactive agents, the addition of which will turn the medical device into a localized drug delivery system.

Abstract: A stent assembly (10) is formed with a plurality of stent rings (12) which have sections (16, 18, 24) which are of a non-biodegradable material and struts and tie bars (20, 14) which are at least partially biodegradable. The stent ring (12) thus partially biodegrades in a patient over time. The structure is such that the apices (16, 18, 24) of the stent ring (12) are of a non-biodegradable material and thus able to behave as a conventional non-biodegradable stent, that is with the same flexibility and expansion force consistent with such stent rings. Parts (34, 44) of the stent ring (12) will degrade in time, thereby reducing the restoring force produced by the stent ring (12) and reducing the amount of foreign material retained within a patient's body. In one embodiment, the stent ring (12) will separate into individual components after a period.

Abstract: A collagenous biomaterial medical device comprising a molded sponge material formed from comminuted submucosa fragments that have not been cross-linked with a cross-linking agent, wherein said submucosa has at least one biotropic agent, and wherein said biotropic agent is a growth factor is disclosed.

Abstract: The invention relates to implants that are implanted into living beings as temporary implants and that disintegrate in the body through biological adsorption over a period of time, in addition to a process for producing aforesaid implants. The implant according to the invention consists of magnesium or a magnesium master alloy. It is formed from fibers of magnesium or a magnesium master alloy that are connected to one another through sintering bridges that are locally spaced vis-à-vis each other and form an open-pored body. The fibers may be produced with the help of the melt extraction process and may subsequently be sintered with one another.

Abstract: The present invention relates to protein matrix materials and devices and the methods of making and using protein matrix materials and devices. More specifically the present invention relates to protein matrix materials and devices that may be utilized for various medical applications including, but not limited to, drug delivery devices for the controlled release of pharmacologically active agents, encapsulated or coated stent devices, vessels, tubular grafts, vascular grafts, wound healing devices including protein matrix suture material and meshes, skin/bone/tissue grafts, biocompatible electricity conducting matrices, clear protein matrices, protein matrix adhesion prevention barriers, cell scaffolding and other biocompatible protein matrix devices. Furthermore, the present invention relates to protein matrix materials and devices made by forming a film comprising one or more biodegradable protein materials, one or more biocompatible solvents and optionally one or more pharmacologically active agents.

Abstract: A radio-opaque marker for medical implants comprising between 10 and 90 weight percent of a biodegradable base component, between 10 and 90 weight percent of one or more radio-opaque elements selected from the consisting of I, Au, Ta, Y, Nb, Mo, Ru, Rh, Ba, La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb, Lu, Hf, Ta, W, Re, Os, Ir and Bi as a marker component and 10 weight percent of residual components, the aforementioned components amounting to 100 weight percent.

Abstract: A tissue engineered construct made totally or in part from biocompatible materials and mammalian cells and/or cell products is provided. These constructs are useful in regenerating complex tissues such as bone, ligament and tendon, which may fabricated into medical devices suitable for use in the treatment of injuries and maladies such as rotator cuff injuries, periodontal disease and hernia.

Abstract: A composite material for positioning in the anatomy to form a selected function therein. The composite may be resorbable over a selected period of time. The composite may allow for selected bone ingrowth as absorption of the composite occurs.

Abstract: An implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. To prevent unintentional displacement of the graft or extrusion of the graft from the fistula of a patient, the graft may be provided with a cap that extends laterally from at least one end of the body of the graft, where the cap may be integral with the body of the graft, attachable to at least one end of the body of the graft, and/or moveable along the body of the graft. The graft may also have a tail that extends from one end of the body of the graft to assist in placement of the graft in a fistula tract. The graft may be an integral unit made of a single material, such as a heterograft material, or may include distinct components made of the same or different materials. Methods for closing a fistula tract are also provided.

Abstract: Bioresorbable wall reinforcement implants include a bioresorbable porous matrix based on a collagen sponge which defines first pores, a bioresorbable porous three-dimensional knit which defines second pores, with the matrix filling the knit and all the first and second pores being at least partially interconnected with one another. Tissue engineering supports including such an implant and uses thereof are also described.

Abstract: An implant with anti-inflammatory or antibacterial effects, or both, for implantation in a human or animal body, the implant having a set of porous grains or granules, wherein at least a plurality of the porous grains or granules include titanium, one or more titanium oxides or titanium alloy and have a titanium oxide layer on their surface and have a mean length from one side to the opposite side, through a geometrical center, of at least 200 ?m and up to 5 mm and a mean specific surface area of at least 0.15 m2/g according to the BET method. Also featured is a population of grains or granules having anti-inflammatory or antibacterial effects, or both. Further featured is a method of producing an implant, a method for deriving a population of grains or granules, and a method for treating a condition with a porous grain or granule.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: A medical implant includes a metal composite that comprises a cellular nanomatrix comprising a metallic nanomatrix material and a metal matrix disposed in the cellular nanomatrix, the medical implant being configured to disintegrate in response to contact with a fluid. A method for repairing tissue includes disposing an implant in a patient, the implant comprising a metal composite which comprises: a cellular nanomatrix comprising a metallic nanomatrix material; and a metal matrix disposed in the cellular nanomatrix; contacting tissue of the patient with the implant, the tissue being in need of repair; and non-operatively removing the implant to repair the tissue.

Abstract: A laminated, bioimplantable dural graft product is configured for use as both an onlay graft and a suturable graft. The dural graft product is sufficiently pliable so as to sufficiently conform to a curvature of a tissue surface to which it is applied, such as the curved surface of a meningeal membrane. The use of the graft product can have improved properties, including suture retention strength and fluid impermeability. To use the dural graft product as an implant to replace, reinforce or strengthen bodily tissue, or to act as an adhesion barrier, the dural graft is placed in contact with bodily tissue and conforms to the curvature of the bodily tissue. Sutures can be used to maintain the contact between the dural graft and the bodily tissue.

Abstract: A biocompatible material may be configured into any number of implantable medical devices including a vascular closure device. The vascular closure device includes a fibrous structure formed from at least one randomly oriented fiber, the randomly oriented fiber comprising at least one polymer, and at least one agent, in therapeutic dosage, incorporated into at least one of the fibrous structure and the at least one randomly oriented fiber.

Abstract: This invention provides aragonite- and calcite-based scaffolds for the repair, regeneration, enhancement of formation or a combination thereof of cartilage and/or bone, which scaffolds comprise at least two phases, wherein each phase differs in terms of its chemical content, or structure, kits comprising the same, processes for producing solid aragonite or calcite scaffolds and methods of use thereof.

Abstract: The present invention provides a nerve regeneration-inducing tube in which collagen having excellent adhesive property, cell growth property and differentiation inducing property to nerve cells is used as a scaffold for the nerve regeneration. The nerve regeneration-inducing tube is characterized in using the collagen which is made the concentration of sodium chloride contained therein not more than 2.0% by weight or, preferably, 0.1 to 1.5% by weight in a dry state. Purification of collagen is carried out by means of an isoelectric precipitation where the pH is 6.0 or higher and is lower than 10.0.

Abstract: A method of implanting a fabric into a body to repair a pelvic floor includes preventing wrinkle formation in the fabric with a bio-absorbable support, and implanting the bio-absorbable support and the fabric into the body.

Abstract: A bioerodible conductive tissue scaffold that can provide, e.g., improved tissue growth.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: Provided herein re a composition and a coating or a device (e.g., absorbable stent) that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: A method for utilizing an implant in a human breast includes forming a breast cavity within the breast at a lumpectomy site, the breast cavity having surrounding tissue; forming a substantially radio-opaque implant constructed of biocompatible and biodegradable material configured to allow for in-growth of fibrous tissue into and replacing the biocompatible and biodegradable material, the biocompatible and biodegradable material being elastically compressible; sizing the substantially radio-opaque implant to occupy the breast cavity; and implanting within the breast cavity the substantially radio-opaque implant to support the tissue surrounding the breast cavity, the step of implanting including compressing the biocompatible and biodegradable material.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: The present invention relates generally to an antibacterial coating which is composed of silver, to medical tools and to implants comprising such a coating and to a method as well to an apparatus for the production of such a coating. The medical tools or the dental or orthopaedic implant comprises a metal or metal alloy having a treated surface wherein the treated surface is at least partially converted to an oxide film by plasma electrolytic oxidation using a colloid-dispersed system and wherein the converted surface is partially covered by islands formed by colloid-dispersed silver-particles of the colloid-dispersed system. An Ag—TiO2 coating shows excellent properties in terms of antibacterial efficacy (even against multi-resistant strains), adhesion and biocompatibility. The life-time of an implant in a human body is increased. The antibacterial coating can be used in the field of traumatology, orthopaedic, osteosynthesis and/or endoprothesis, especially where high infection risk exists.

Abstract: The present invention relates to medical prostheses and methods of manufacturing those devices. In particular, the prostheses are temporarily stiffened meshes with particular coatings to provide initial stiffness and thereby permit easier surgical handling for treatment or reconstruction of soft tissue defects. Preferred embodiments include surgical meshes coated with one or more biodegradable polymers that can act as a stiffening agent by coating the filaments or fibers of the mesh to temporarily immobilize the contact points of those filaments or fibers and/or by increasing the stiffness of the mesh by at least 1.1 times its original stiffness. The devices of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use.

Abstract: The invention relates to a method for producing a preform by means of an electrospinning process. The present invention also relates to the use of the present preform as a substrate for growing human or animal tissue thereon. The present invention furthermore relates to a method for growing human or animal tissue on a substrate, wherein the present preform is used as the substrate.

Abstract: Methods, devices and compositions for fusing adjacent vertebrae, and otherwise localizing bone growth, are provided. In one form of the invention, a method for fusing adjacent vertebrae includes preparing a disc space for receipt of an intervertebral disc implant in an intervertebral disc space between adjacent vertebrae, inserting the implant into the intervertebral disc space and providing an osteoinductive composition that includes an osteoinductive factor in a pharmaceutically acceptable carrier. The carrier is advantageously substantially impermeable to efflux of the osteoinductive factor and is released as the carrier is resorbed or biodegraded. Preferred carriers include a hardened, resorbable carrier, such as a calcium phosphate cement that retains at least about 50% of the osteoinductive factors greater than about 2 days. Preferred osteoinductive factors are growth factors and include bone morphogenetic proteins and LIM mineralization proteins.

Abstract: Embodiments of the invention include a medical device and a method of manufacturing a medical device having a porous scaffold in combination with a bioactive material. In some embodiments, particularly limited thicknesses of the bioactive material are applied within pores of the porous structure.

Abstract: Embodiments of the invention provide compositions comprising bio degradable polymers, medical implants fabricated from these compositions and methods of using such implants. Many embodiments provide medical implants comprising a first polymer backbone having a first rate of biodegradation and a second polymer backbone having a second rate of biodegradation faster than the first rate. In some embodiments, the second backbone is configured to be replaced by a natural tissue layer. The first backbone provides a scaffold for the implant while the second backbone degrades. This scaffold can enhance mechanical properties of the implant including various aspects of mechanical strength such as tensile, bending, hoop and yield strength; and elasticity. The scaffold also serves to maintain a minimum level of structural support of the implant during the period of degradation of the second backbone or for the entire life of the implant so that the implant does not mechanically fail.

Abstract: The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.