Abstract: A biocompatible resin composition that is used in the manufacture of a dissolvable microneedle that is used for the transdermal delivery of one or more active pharmaceutical ingredients to a subject. The biocompatible resin composition includes lithium phenyl-2,4,6-trimethylbenzoylphospinate, water, and poly(ethylene glycol) diacrylate (molecular weight 550), and may include methacrylated hyaluronic acid, that is capable of forming a structurally stable microneedle patch. The microneedle patch is formulated with the biocompatible resin composition using a continuous, one-step process utilizing additive manufacturing. Once manufactured, the microneedle patches are formulated to adhere to an outer layer of a subject's skin. Once administered to the subject, the microneedle compositions create microscopic pathways into the subject's subdermal layers to deliver one or more active agents to the subject, such as to the subject's bloodstream.

Abstract: Bio-adhesive textured surfaces are described which allow implants to be localized within a living body. Hierarchical levels of texture on an implantable medical device, some capable of establishing a Wenzel state and others a Cassie state, may be employed to interface with living structures to provide resistance to device migration. Since a gaseous state is traditionally required to establish a Cassie or Wenzel state, and gases do not remain long in living tissue, described herein are tissue/device interactions analogous to the above states with the component normally represented by a gas replaced by a bodily constituent, wherein separation of tissue constituents develops and an analogous Cassie, Wenzel, or Cassie-Wenzel state evolves. Further methods of making molds to produce said devices are described herein.

Abstract: The present invention provides tissue scaffolds, methods of generating such scaffolds, and methods of use of such scaffolds to generate aligned and functional neural tissues for use in methods including regenerative medicine, wound repair and transplantation.

Abstract: Medical implants comprising biocompatible materials and having surface features that may assist in biocompatibility upon implantation in the body are described. Methods for manufacturing such implants are also described. The manufacturing process may include applying a biocompatible material to a texturized surface of a mold. The implants may include various features to assist their positioning, fixation, and/or identification during and/or after implantation.

Abstract: This disclosure relates generally to repair of defective hernias by use of a mesh material. However, inaccurate hernia defect measurements can cause ineffective treatment and a waste of mesh material. Therefore, accurate hernia defect measurements can aid in the effective treatment and repair of hernia defects.

Abstract: Methods for texturing surgical implants, for example, breast implants, are provided. The methods include the use of computer controlled 3D printing of a sacrificial material to create a textured surface on an unfinished surface of the implant.

Abstract: The present disclosure relates to implantable medical devices which include a film which includes predetermined folding characteristics via predetermined thicknesses along different areas of the implant.

Abstract: Methods for texturing surgical implants, for example, breast implants, are provided. The methods include the use of computer controlled 3D printing of a sacrificial material to create a textured surface on an unfinished surface of the implant.

Abstract: A tissue engineered model (TEM) structure, an apparatus and method for making a TEM structure, and methods of using a TEM structure are disclosed. In an embodiment, the TEM structure includes at least one TEM segment. Each TEM segment includes a frame defining a bounded area, the frame having a height, a first edge, and a second edge opposite the first edge, each of the first edge and the second edge defining a perimeter of the bounded area, and the height defining a distance between the first edge and the second edge; a membrane affixed to the first edge about a perimeter of the frame; and a solidified gel and cell matrix disposed within the bounded area within the frame, wherein the solidified gel and cell matrix substantially fills a volume defined by the bounded area and the height of the frame.

Abstract: A method is disclosed for changing the spring rate of an implantable layer for use with a surgical instrument which includes the steps of obtaining an implantable layer having a first spring rate, wherein the implantable layer is at least partially comprised of a material having a glass transition temperature and a melting temperature, heating the implantable layer to a temperature higher than the glass transition temperature and lower than the melting temperature, deforming the implantable layer to change the first spring rate to a second spring rate, wherein the second spring rate is different than the first spring rate, allowing the implantable layer to cool below the glass transition temperature, and releasing the implantable layer.

Abstract: The systems and methods described herein related generally to a device that enables the directional control of flow through an anatomical tract of the body. More particularly, the device described herein includes a valve from a plurality of projections. In some implementations, the projections are configured as flaps, posts, or any combination thereof. In some implementations, the device is implanted into a patient's esophagus to prevent gastroesophageal reflux disease. The plurality of projections allow flow into a patient's stomach while substantially preventing a backflow of undesired fluids from the patient's stomach to the patient's esophagus.

Abstract: A method and apparatus are provided for treating cardiac tissue to modulate ischemic heart tissue with topical sub-atmospheric pressure to minimize cell death and damage.

Abstract: A method and apparatus are provided for treating cardiac tissue to modulate ischemic heart tissue with topical sub-atmospheric pressure to minimize cell death and damage.

Abstract: The present invention relates to a prosthesis comprising at least two pieces of knitted fabric and to the method of manufacturing it using a sonotrode to perform ultrasonic welding. The prosthesis comprises at least one first piece of knitted fabric and at least one second piece of knitted fabric, which are welded together by means of a plurality of welds situated in a joining region in which at least a portion of the said first and second pieces of knitted fabric are superposed, the said first and second pieces of knitted fabric each comprising a group of yarns extending respectively in first and second directions A and B, characterized in that the said directions A and B are substantially aligned with one another in the said joining region, and each said weld in the joining region is of elongate shape with its longitudinal axis being aligned with the said directions A and B.

Abstract: A surgical implant (10) comprises an areal, flexible, porous basic structure (12) having a first face and a second face. At least one resorbable dyed film piece (20) is attached to the basic structure (12) and comprises a plurality of solid protrusions emerging from the dyed film piece (20) in a direction away from the basic structure (12). The at least one dyed film piece (20) is arranged in a shape structure which is asymmetric (“E”) in the area of the basic structure (12). Optionally, the implant (10) further comprises an adhesion barrier sheet (16).

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: An artificial tissue including an internal mass transport network having a plurality of channels, wherein the channels are designed to substantially mimic naturally occurring vascular network and a method for creating an internal transport system within a tissue scaffold to improve circulation, diffusion, and mass transport properties by utilizing computer-aided tissue engineering (CATE). The artificial tissue has the internal mass transport network of channels embedded, deposited, or molded within a scaffold, wherein the channels are made from a biodegradable transporting material and the scaffold is made from a scaffold material. The artificial tissue of the invention includes a basic circulatory system embedded within the tissue scaffold. This system provides mass transport throughout the entire scaffold and degrades after the new circulatory system develops.

Abstract: A surgically implantable mesh for covering a tear or rupture in a lining associated with an interior body cavity. A mat shaped polymer body has top and bottom spaced apart surfaces which are communicable at intervals by an interior configuration defined in the body and which promotes tissue in-growth following implantation. An antibacterial additive is intermixed with the polymer in a viscous state prior to formation and can included at least one of silver, gold, copper, bronze, or ground bamboo fibers.

Abstract: The present invention provides tissue scaffolds, methods of generating such scaffolds, and methods of use of such scaffolds to generate aligned and functional tissues for use in methods including regenerative medicine, wound repair, and transplantation.

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: The invention provides a biocompatible silicone implant that can be securely affixed to living tissue through interaction with integral membrane proteins (integrins). A silicone article containing a laser-activated surface is utilized to make the implant. One example is an implantable prosthesis to treat blindness caused by outer retinal degenerative diseases. The device bypasses damaged photoreceptors and electrically stimulates the undamaged neurons of the retina. Electrical stimulation is achieved using a silicone microelectrode array (MEA). A safe, protein adhesive is used in attaching the MEA to the retinal surface and assist in alleviating focal pressure effects. Methods of making and attaching such implants are also provided.

Abstract: A method of manufacturing a tubular medical implant is provided. The method includes forming a hollow first tube with a first diameter and a first plurality of pores formed thereon and a hollow second tube with a second unstretched diameter and a second plurality of pores formed thereon. The second unstretched diameter is greater than the first diameter. At least a portion of the first tube slides within the second tube to create an overlapped area of the first tube and the second tube. The first tube and second tube are then bonded together in the overlapped area.

Abstract: A three-dimensional scaffold for a medical implant includes a plurality of layers bonded to each other. Each layer has a top surface and a bottom surface and a plurality of pores extending from the top surface to the bottom surface. Each layer has a first pore pattern of the pores at the top surface and a different, second pore pattern at the bottom surface. Adjacent surfaces of at least three adjacent layers have a substantially identical pore pattern aligning to interconnect the pores of the at least three adjacent layers to form a continuous porosity through the at least three adjacent said layers.

Abstract: A surgical implant (1) comprises a basic structure (2) having a first face (4) and a resorbable film (6) attached to the first face (4) of the basic structure (2). A plurality of solid protrusions (8) emerges from the film (6) in a direction away from the basic structure (2). The protrusions (8) comprise a shape defined by a respective body and a respective head, the body emerging from the film (6) and terminating in the head, and the head projecting laterally with respect to the body.

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: Bio-selective textured surfaces are described which mediate foreign body response, bacterial adhesion, and tissue adhesion on devices implanted in a mammalian body. Hierarchical levels of texture, some capable of establishing a Wenzel state others a Cassie state, are employed to interface with living structures, either to promote or discourage a particular biological response/interaction. Since a gaseous state is traditionally required to establish a Cassie or Wenzel state, and gases do not remain long in living tissue, described are tissue/device interactions analogous to the above states with the component normally represented by a gas replaced by a bodily constituent, wherein separation of tissue constituents develops and a desired interaction state evolves.

Abstract: Bio-adhesive textured surfaces are described which allow implants to be localized within a living body. Hierarchical levels of texture on an implantable medical device, some capable of establishing a Wenzel state and others a Cassie state, are employed to interface with living structures to provide resistance to device migration. Since a gaseous state is traditionally required to establish a Cassie or Wenzel state, and gases do not remain long in living tissue, described are tissue/device interactions analogous to the above states with the component normally represented by a gas replaced by a bodily constituent, wherein separation of tissue constituents develops and an analogous Cassie, Wenzel or Cassie-Wenzel state evolves.

Abstract: An extracellular matrix (ECM) construct having a biodegradable support scaffold that includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein, and at least a first layer of first ECM material disposed on the top surface of the support scaffold.

Abstract: The implant includes an outer layer of ePTFE which exhibits extensibility normally not associated with ePTFE. The ePTFE is reduced in length by deforming the fibrils between the nodes while maintaining the nodes in a substantially flat configuration. Various implant configurations that can include the outer layer described are also disclosed.

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: 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: This disclosure provides implantable devices coated with microporous surface layers with macrotopographic features that improve bio-integration at the interface of the implantable devices and the surrounding tissue.

Abstract: Biocompatible materials are provided which include various textured surfaces, which when such materials are implanted in a human being, for example, as a component of a breast prosthesis, provide for tissue integration, reduce the linear alignment of collagen fibers around the implant and reduce or eliminate the potential for capsular contracture.

Abstract: A method for preparing placenta membrane tissue grafts for medical use, includes obtaining a placenta from a subject, cleaning the placenta, separating the chorion tissue from the amniotic membrane, mounting a selected layer of either the chorion tissue or the amniotic membrane onto a drying fixture, dehydrating the selected layer on the drying fixture, and cutting the selected layer into a plurality of tissue grafts. Preferably, the drying fixture includes grooves or raised edges that define the outer contours of each desired tissue graft, after they are cut, and further includes raised or indented logos that emboss the middle area of the tissue grafts during dehydration and that enables an end user to distinguish the top from the bottom side of the graft. The grafts are comprised of single layers of amnion or chorion, multiple layers of amnion or chorion, or multiple layers of a combination of amnion and chorion.

Abstract: A surgical implant is made from biocompatible fiber material as a woven textile fabric, in particular in the form of a vascular prosthesis, the woven fabric being so configured that its permeability to blood is so low that the blood impregnates the textile fabric upon implantation and seals it off by coagulating, but does not flow through it.

Abstract: The present invention relates to a novel bone graft and methods for producing said graft. Said bone graft can be used for surgical, plastic and/or cosmetic bone replacement for a patient in need thereof. The bone graft is made of a scaffold or matrix of sheet material having a 3-dimensional pattern of a continuous network of voids and/or indentations for enhancing new bone growth.

Abstract: This disclosure provides implantable devices coated with microporous surface layers with macrotopographic features that improve bio-integration at the interface of the implantable devices and the surrounding tissue.

Abstract: A collagen-coated tissue based membrane that is smooth on both sides so as to inhibit cell and tissue adhesion. Also disclosed are methods for making a collagen-coated tissue-based membrane.

Abstract: Hard-tissue implants are provided that include a bulk implant, a face, pillars, and slots. The pillars are for implantation into a hard tissue. The slots are to be occupied by the hard tissue. The hard-tissue implant has a Young's modulus of elasticity of at least 10 GPa, has a ratio of the sum of (i) the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots of 0.40:1 to 0.90:1, does not comprise any part that is hollow, and does not comprise any non-pillar part extending to or beyond the distal ends of any of the pillars. Methods of making and using hard-tissue implants are also provided.

Abstract: A tissue implant member for implanting in living tissue is provided. The implant is formed of a fibrous mat of tantalum filament having a diameter less than about 10 microns.

Abstract: An implant device for humans or mammals has a body structure having an exposed surface and one or more selected portions of the exposed surface having a bone formation enhancing 3-dimensional pattern. The exposed surface can be on exterior portions of the body structure or internal portions of the body structure or both. The one or more selected portions of the exposed portions having the bone formation enhancing 3-dimensional patterns are in the external exposed surfaces or in the internal exposed surfaces or both internal and external exposed surfaces.

Abstract: The construct described herein allows opposing tissues to form adhesions with either side of the construct, as part of the natural healing process. The construct however is multi-layered, wherein the space between the layers provides the protection from unwanted adhesions forming between and bonding separate tissues. In one embodiment, this space between layers of the construct may be developed spontaneously, that is the multiple layers are released by design after a finite time and the opposing tissues are free to move independent of each other, free of adhesions.

Abstract: A method for preparing placenta membrane tissue grafts for medical use, includes obtaining a placenta from a subject, cleaning the placenta, separating the chorion tissue from the amniotic membrane, mounting a selected layer of either the chorion tissue or the amniotic membrane onto a drying fixture, dehydrating the selected layer on the drying fixture, and cutting the selected layer into a plurality of tissue grafts. Preferably, the drying fixture includes grooves or raised edges that define the outer contours of each desired tissue graft, after they are cut, and further includes raised or indented logos that emboss the middle area of the tissue grafts during dehydration and that enables an end user to distinguish the top from the bottom side of the graft. The grafts are comprised of single layers of amnion or chorion, multiple layers of amnion or chorion, or multiple layers of a combination of amnion and chorion.

Abstract: A method of texturing a soft prosthetic implant shell, such as a silicone breast implant shell. A soft prosthetic implant with a textured external surface layer of silicone elastomer and having an open-cell structure is made by adhering and then dissolving round salt crystals. The resulting roughened surface has enhanced physical properties relative to surfaces formed with angular salt crystals. An implant having such a textured external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.

Abstract: A tissue scaffold fabricated from tantalum fiber forms a rigid three-dimensional porous matrix having a tantalum composition. Porosity in the form of interconnected pore space is provided by the space between the tantalum fiber in the porous matrix. Strength of the porous matrix is provided by tantalum fiber fused and bonded into the rigid three-dimensional matrix having a specific pore size and pore size distribution. The tissue scaffold supports tissue in-growth to provide osteoconductivity as a tissue scaffold, used for the repair of damaged and/or diseased bone tissue.

Abstract: The present invention relates to a prosthetic fabric (5) comprising an arrangement (2) of yarns that define at least first and second opposite faces (2a, 2b) for said fabric, said fabric comprising on at least said first face, one or more barbs (3) that protrude outwards relative to said first face, said fabric being covered, at least partly, on said second face with a microporous layer made of a bioresorbable material, said barbs being covered with a coating made of a water-soluble material. The invention also relates to a process for obtaining such a fabric and to prostheses obtained from such a fabric.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: A method of making a composite prosthetic device, such as a hernia repair device, includes providing a support layer, juxtaposing a layer of an absorbable material with the support layer, and disposing an absorbable adhesive between the support layer and the layer of an absorbable material. The method includes heating the layers for melting the absorbable adhesive so as to bond the support layer with the layer of the absorbable material. Before the heating step, the moisture content of at least one of the layers is increased for improving thermal conductivity between the layers so as to enhance the strength of the bonds formed between the layers. The moisture content may be increased by exposing at least one of the layers to an environment having elevated relative humidity. In one embodiment, the support layer is polypropylene mesh, the layer of the absorbable material is oxidized regenerated cellulose, and the absorbable adhesive is polydioxanone.

Abstract: A method of treating a ligament or tendon according to the present invention can include inserting a tissue-generating implant into the ligament or tendon to thereby treat the defect. The tissue-generating implant has a plurality of microparticles. The microparticles subsequently form a biological scaffold which operates at least as partial connective tissue in the ligament or tendon giving structural support during regrowth.

Abstract: The present invention describes an implantable tissue lifting and fixation device. More particularly, the present invention describes a temporal brow lifting device comprised of a bio-absorbable supportive backing. The device has a shape of a curvilinear end and a tail end region. The curvilinear end region comprises a plurality of attachment points protruding from the supportive backing, and the tail region comprises of a plurality of cavities in order to secure the device at the desired elevated position in the deep temporal fascia. The plurality of attachment points distributes tension in a multi-vector direction over the contact area between the device and the tissue. The attachment points can be manufactured separately and attached, however, preferably, the attachment points are made integral with the temporal brow lifting device.