Abstract: A device comprising a microstructured surface wherein in one aspect, the microstructured surface is arranged hierarchically with dual-functioning textured features. The surface may achieve adhesive properties by varying the parameters of the microstructure features. Additionally, the surface may achieve cellular and/or tissues in-growth functionality by varying the same parameters. Generally, the dual-functional aspect includes at least one surface feature having a varied periodicity which may be imposed on at least one other surface feature.

Abstract: It is described a composite hydrogel containing egg white and alginate (EWA) polymers, and a method of producing same, wherein the alginate is cross-linked using frozen calcium chloride disks, creating a scaffold for cells comprising a slow-rate ions diffusion through the matrix, ensuring a homogenous crosslink and smooth surface.

Abstract: A method of preparing a sterilized heart valve, the method comprising: compressing a compressible frame of a heart valve from an expanded configuration to a crimped configuration; the heart valve comprising the frame and a plurality of leaflets coupled to the frame; wherein each of the plurality of leaflets comprises a dry, unfixed, decellularized, antigen-free biological tissue that has been treated with a solution comprising a polyol or polyhydric alcohol; packaging the heart valve within a sealed packaging system while the heart valve is in the crimped configuration; and sterilizing the heart valve packaged within the sealed packaging system with one or more cycles of electron beam radiation.

Abstract: An implant delivery device for introducing and positioning implants within patients may include a sheath member having a distal end, a proximal end, and a central longitudinal axis, the sheath member defining a lumen along the central longitudinal axis. The implant delivery device may additionally include an implant delivery shaft having a distal end and a proximal end, the implant delivery shaft disposed at least partially within the sheath member and an implant spreader assembly disposed at the distal end of the implant delivery shaft. In some embodiments, the implant delivery device may further include a cap disposed at the distal end of the sheath member, the cap obstructing at least a portion of an opening into the lumen of the sheath member.

Abstract: An implantable and biodegradable polymeric matrix with reduced foreign body response for the regeneration and/or reconstruction and/or creation of soft and connective tissue and/or organs is provided. The matrix has a density equal to or lower than 40 kg/m3, a plurality of local thicknesses of a solid component with an arithmetic mean equal to or lower than 95 ?m, an average size of pores/void spaces equal to or lower than 15,000 ?m, a surface roughness Ra of the solid component with an arithmetic mean equal to or lower than 3 ?m; and a contact angle ? of the solid component lower than 110°, preferably in the range 10° to 90°, and more preferably in the range 30° to 60°.

Abstract: Soft tissue grafts, packaged soft tissue grafts, and methods of making and using soft tissue grafts are disclosed. One soft tissue graft includes processed tissue material having first and second opposed surfaces. The first and second opposed surfaces are bounded by first and second edges. The first edge has a concave shape that curves toward the second edge. The second edge has a convex shape that curves away from the first edge. The first surface comprises a plurality of apertures. At least one of the apertures is formed from a multi-directional separation in the first surface. One method of making a soft tissue graft includes positioning a cutting die on a surface of tissue material, pressing the cutting die into the tissue material to cut the tissue material, and processing the cut tissue material to create processed tissue material.

Abstract: Introduced here are novel techniques for augmenting the lips through superficial linear injection of dermal fillers. At a high level, these techniques are representative of a two-step approach to augmentation. In the first stage, an implement that is appropriately positioned inside a lip can be moved sideways—an action referred to as a “side push.” In the second stage, dermal filler can be ejected from the implement so as to fill the resulting void. These techniques can be used by healthcare professionals to reshape the lips for medical or aesthetic purposes. These techniques were developed in an attempt to permit augmentation of the outer surface of a lip so as to increase its volume by expanding sideways while turning the lip outward. With these techniques, the desired result—namely, a plumper lip—may be readily and consistently achievable.

Abstract: The invention broadly provides an implantable medical device comprising a liquid rope coil scaffold. The implant may consist essentially of the scaffold, where the scaffold is the implant and pores in the scaffold may incorporates one or more agents (i.e. drugs, growth factors), or the scaffold may comprise only part of the medical device, for example an implant that is partly or fully covered with a layer of the scaffold. The porosity of the scaffold may be tailored to suit the application, for example a porosity that is tailored to hold and release drug or biological molecules in vivo, a porosity to provide a surface roughness that is conducive to promotion of in-vivo bio-integration (for example vascularisation) or prevention of fibrosis, or a porosity that provides structural strength. The scaffold may be essentially tubular, or may be provided as a planar structure, or may be any shape and can be used to coat, fully or partially any shape or size of medical implant.

Abstract: A patella implant for knee arthroplasty includes a cap and a base. The cap has an articulating surface and a plurality of first connection members. The base is to be attached to the backside of a patella of a patient. The base includes a cap support mounted to the cap. The cap support includes a plurality of first connection recesses. Each first connection member of the cap is disposed in a corresponding one of the first connection recesses of the cap support to mount the cap to the base.

Abstract: Intervertebral implants for implanting into an intervertebral space are provided. The implants can comprise one or more layers that are operably attached to one another. An implant can comprise a first layer having a first mating surface that mates with a second mating surface of a second layer. The first mating surface and the second mating surface can have features that allow them to complement each other. The implants can include one or more bore holes for receiving a fixation member. The bore holes can be horizontal, vertical or diagonal. In some cases, the bore holes will be blind bore holes.

Abstract: Bioactive porous bone graft implants in various forms suitable for bone tissue regeneration and/or repair, as well as methods of use, are provided. The implants are formed of bioactive glass and have an engineered porosity. The implants may take the form of a putty, foam, fibrous cluster, fibrous matrix, granular matrix, or combinations thereof and allow for enhanced clinical results as well as ease of handling.

Abstract: Materials for soft tissue repair, and in particular, material for hernia repair. These materials may be configured as an implant, such as a graft, that may be implanted into a patient in need thereof, such as a patient having a hernia or undergoing a hernia repair surgical procedure. These grafts may include a first layer comprising a substrate (e.g., mesh) and a second layer comprising a sheet of anti-adhesive material. The layers may be attached with a plurality of relatively small attachment sites that are separated by regions in which the two layers are not attached, to provide a highly compliant graft.

Abstract: Compositions comprising perforated, unseparated amnion/chorion; perforated, separated amnion; and perforated, separated chorion derived from the placenta and methods of preparing and using those compositions are provided. Perforation of placental tissue before or during processing may allow for one or more benefits such as more efficient removal of blood remnants, retention of wound healing and tissue regeneration components, better handling characteristics, or improved healing capacity. The present invention also includes methods of healing a wound of the skin, eye, nerve, tendon, or dura comprising applying the perforated compositions of the invention to the wound.

Abstract: A nasal tissue implant for reconstruction and tissue engineering of nasal tissue in a subject includes a tissue scaffold component comprising a biocompatible polymeric material having a plurality of open pores configured to support cell growth. The tissue scaffold component conforms to a portion of the subject's nasal region and defines at least a portion of the subject's nasal anatomy. A method of making an implantable nasal tissue implant for reconstructing a portion of a nasal anatomy of a human or other animal subject is also provided that includes laser sintering or three-dimensional (3D) printing a biocompatible polymeric material to form a tissue scaffold component comprising a biocompatible polymeric material having a plurality of open pores configured to support cell growth. Again, the tissue scaffold component substantially conforms to a nasal region specific to the human or other animal subject.

Abstract: Implantable tensile load-bearing grafts having synthetic components stitched through biological components are disclosed. The synthetic components can be biodegradable and/or non-biodegradable and of differing tensile strengths from each other and the biological component. Methods of making the grafts are also disclosed.

Abstract: A dissolvable composition is disclosed. The composition includes a first material (e.g., an anode), a second material (e.g., a cathode), and a third material (electrolytic material). The third material is reactive with water to form an electrolyte. The first material and the second material are electrochemically different such that the first material and the second material are capable of galvanic reaction in the presence of water and electrolytes. Also disclosed are tools or other apparatus made from the composition, as well as processes, systems, and apparatus for making and using such compositions, tools, and other apparatus.

Abstract: A coated tubular construct for biological and industrial applications includes a plurality of channels, where each channel is radially surrounded by a wall comprising a first polymer, and a conformal coating comprising a second polymer is disposed on an outer and/or an inner surface of each wall. A method of producing a tubular construct includes 3D printing a template structure comprising a sacrificial material and a photoinitiator, and immersing the template structure in a first prepolymer solution comprising a first prepolymer and a co-initiator. During the immersion, the template structure is exposed to light, and the first prepolymer undergoes radical polymerization to conformally coat the template structure with the first polymer, forming a coated template. The sacrificial material is removed from the coated template, and a tubular construct comprising the first polymer is formed.

Abstract: Provided herein are improved compositions and methods of making and using the same, the composition comprising a polymer and a ceramic present at a ratio of from 3:1 to 1:3 of polymer:ceramic by weight, wherein the composition comprises or is a composite of the polymer and the ceramic having improved printability and/or having an improved elastic modulus and/or improved stress at failure (e.g., as compared to a blend of the polymer and the ceramic). Improved medical implants incorporating the same are also provided.

Abstract: This tissue-joining member comprises non-crosslinked fibrous collagen. A laminate body comprises: a support; a joining member that is layered on one surface of the support; and a first adhesive layer that is layered on said one surface of the support in a region on which the joining member is not layered. The method for using the joining member or the laminate body comprises: a heating step in which the joining member or the laminate body is heated to less than 60° C. and greater than body temperature after having being layered on the tissue; and a cooling step in which the heated joining member or laminate body is cooled to body temperature or lower. A treatment system comprises a heating unit and the joining member or the laminate body.

Abstract: Apparatus for delivering a surgical mesh, the apparatus comprising: a hollow outer tube having a distal end and a proximal end; a distal housing mounted to the distal end of the hollow outer tube; a hollow inner tube having a distal end and a proximal end, wherein the hollow inner tube is slidably disposed within the hollow outer tube; a central rod having a distal end and a proximal end, wherein the central rod is slidably disposed within the hollow inner tube; an actuation element mounted to the proximal end of the central rod; and a surgical mesh carriage comprising a plurality of legs, wherein each of the plurality of legs comprises a first hinged end mounted to the distal end of the hollow inner tube and a second hinged end mounted to the distal end of the central rod.

Abstract: The present invention relates to a mesh or membrane covering (2) based on biological material, for example collagen, or biosynthetic material for prostheses (1), in particular for a breast prosthesis (1), said prosthesis (1) having a rear surface that, when applied, is faced towards the person on whom (1) is applied, said covering (2) being characterized in that it provides a fixing system (4; 3) for fixing to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4) or outer perimeter edge foldable on said rear surface of the prosthesis (1) by means (5). The invention further relates to a method for fixing said covering to a prosthesis, a prosthesis comprising said covering and a process for making said covering.

Abstract: The present disclosure relates to skirted hernia repair devices which includes at least a first mesh layer having a first side, a second side, and an outer peripheral edge, a skirt mesh layer positioned on the first side of the first mesh layer, the skirt mesh layer having an inner peripheral edge defining an opening in the skirt mesh layer, and, at least one reinforcement member that prevents the skirt mesh layer from inverting.

Abstract: A method of preventing or reducing the occurrence and/or development of a hernia within a subject at risk of developing a hernia includes implanting a graft material in contact with an opening in an abdominal wall. The graft material promotes healing of the abdominal wall and includes placental or placental derived tissue.

Abstract: A nerve conduit loaded with adipose-derived stem cells and a preparation method thereof are provided. The preparation method includes: S1, adding polycaprolactone and polyvinylpyrrolidone into a binary organic solvent, performing ultrasonic treatment, and then adding reduced graphene oxide nanoparticles to obtain a spinning solution; S2, electrospinning with the spinning solution and then washing for several times to obtain a semi-finished conduit product; and S3, injecting a cell mixture into the semi-finished conduit product to obtain the nerve conduit. A fiber surface of the nerve conduit has groove structures, and thus a specific surface area and cell adhesion sites are increased, and adhesion and proliferation of cells are facilitated.

Abstract: The disclosure herein relates to isolated and purified mammalian fetal allografts and kits and compositions containing these. Also disclosed are methods of preparing isolated and purified mammalian fetal allografts; methods of contacting a wound of a subject with these, and methods of treating a disease or condition with these.

Abstract: To reduce the risk of a ruptured suture after a surgery or the like, a medical apparatus includes a biodegradable sheet in which a plurality of through-holes are formed, a value of a ratio (D/P) of a hole diameter D to a pitch P of the through-hole is in a range of 0.25 or more and less than 40. Such a medical apparatus is useful as an adhesion promoting device for promoting adhesion of biological tissue.

Abstract: A ceramic guide device includes a columnar ceramic guide including a first portion including a first end, a second portion including a second end and having a smaller diameter than a diameter of the first portion, and a third portion disposed between the first portion and the second portion, the columnar ceramic guide provided with an insertion hole through which a long wire electrode can be inserted from the first end to the second end; and the long wire electrode that penetrates through the insertion hole, the long wire electrode including a first protruding portion projecting from the first end, and a second protruding portion projecting from the second end.

Abstract: The present invention relates to an article fabrication system having a plurality of material deposition tools containing one or more materials useful in fabricating the article, and a material deposition device having a tool interface for receiving one of the material deposition tools. A system controller is operably connected to the material deposition device to control operation of the material deposition device. Also disclosed is a method of fabricating an article using the system of the invention and a method of fabricating a living three-dimensional structure.

Abstract: A graft includes a biological graft. An embroidered textile supports the biological graft. Sutures attach the biological graft and the embroidered textile together.

Abstract: The present invention provides a cell cultivation module comprising a polymer porous film and a casing that has two or more culture medium inflow/outflow ports and accommodates the polymer porous film, wherein the polymer porous film is a polymer porous film with a three-layer structure, having a surface layer A and a surface layer B that have a plurality of holes, and a macrovoid layer that is sandwiched between the surface layer A and the surface layer B, the average hole diameter of the holes present in the surface layer A is smaller than the average hole diameter of the holes present in the surface layer B, the macrovoid layer has dividing walls that are connected to the surface layers A and B, and a plurality of macrovoids that are surrounded by the dividing walls and the surface layers A and B, the holes in the surface layers A and B are in communication with the macrovoids, and the polymer porous film is accommodated within the casing.

Abstract: Implants with fillable reservoirs have been developed that are suitable for rhinoplasty, breast reconstruction, ear reconstruction, and replacement, reconstruction or repair of other soft tissues. The implants can be filled with graft material prior to implantation. The implants are preferably made from resorbable polymers, can be tailored to provide different geometries, mechanical properties and resorption rates in order to provide more consistent surgical outcomes. The implants preferably have an interconnected network of unit cells with microporous outer layers and optionally some or all of the unit cells having at least one macropore in their outer layers. The implants can be loaded by injection with microfat, collagen, DCF, cells, bioactive agents, and other augmentation materials, prior to implantation.

Abstract: The present invention relates to a built-in bio-sleeve and preparation method and use thereof. In order to provide a suitable built-in bio-sleeve material for dorsal nerve isolation surgery and penis enlargement surgery, a novel acellular allogeneic dermal matrix material is prepared in the present invention, which is manufactured into a built-in bio-sleeve for the treatment of premature ejaculation and short and small penis. The acellular allogeneic dermal matrix or the built-in bio-sleeve of the present invention is used for dorsal nerve isolation surgery, penis enlargement or lengthening surgery without cutting off the dorsal nerve, thereby avoiding the probability of psychological erectile dysfunction caused by the patient's worry about cutting off the dorsal nerve.

Abstract: High intensity focused ultrasound systems for treating tissue are disclosed herein. A system of treating tissue in a patient in accordance with an embodiment of the present technology can include, for example, an ultrasound source having a focal region and configured to deliver high intensity focused ultrasound energy to a target site in tissue of the patient. The system can further include a controller operably coupled to the ultrasound source. The controller comprises a pulsing protocol for delivering the high intensity focused ultrasound energy with the ultrasound source to the target site. The controller is configured to cause the ultrasound source to pulse high intensity focused ultrasound waves to lyse cells in a volume of the tissue of the subject while preserving an extracellular matrix in the volume of the tissue exposed to the high intensity focused ultrasound waves.

Abstract: A tissue thickness compensator may generally comprise a compressible core comprising a plurality of movable particles, and a wrap surrounding the compressible core. The plurality of movable particles may comprise at least one medicament. A tissue thickness compensator may generally comprise a compressible core comprising a plurality of crushable particles, and a wrap surrounding the compressible core. The plurality of crushable particles may comprise at least one medicament. The compressible core may comprise a material selected from a group consisting of a biocompatible material. The wrap may comprise a material selected from a group consisting of a biocompatible material. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Abstract: An apparatus for use in a surgical procedure for delivering a prosthetic implant comprises a flexible sleeve configured with a first end and a second end, the flexible sleeve being tapered such that a width of a region at the second end is relatively smaller than a width of a region at the first end, and an interior surface of the flexible sleeve that form an interior cavity, the interior cavity being sized to receive the prosthetic implant; one or more surface active coatings are applied to the interior cavity. The flexible sleeve is manipulatable such that when the prosthetic implant is positioned within the interior cavity, a manually applicable directional pressure in the direction of the second end causes the prosthetic implant to extrude from the second end.

Abstract: A patella implant for knee arthroplasty includes a cap and a base. The cap has an articulating surface and a plurality of first connection members. The base is to be attached to the backside of a patella of a patient. The base includes a cap support mounted to the cap. The cap support includes a plurality of first connection recesses. Each first connection member of the cap is disposed in a corresponding one of the first connection recesses of the cap support to mount the cap to the base.

Abstract: Tissue engineering devices and methods employing scaffolds made of absorbable material for use in the human body for tissue genesis and regenerative and cellular medicine including breast reconstruction and cosmetic and aesthetic procedures and supplementing organ function in vivo.

Abstract: A joint spacer, in particular a knee spacer and a hip spacer is provided which is long-lasting and is sufficiently cushioned and abrasion-resistant and which can also support locally very high loads. A method for treating osteoarthritis by inserting a disk-shaped member into a joint of a patient is also disclosed.

Abstract: The present invention generally relates to nanowires. In one aspect, the present invention is generally directed to systems and methods of individually addressing nanowires on a surface, e.g., that are substantially upstanding or vertically-oriented with respect to the surface. In some cases, one or more nanowires may be individually addressed using various integrated circuit (“IC”) technologies, such as CMOS. For example, the nanowires may form an array on top of an active CMOs integrated circuit.

Abstract: A surgical anvil assembly for use with a circular stapling instrument includes an anvil center rod defining a longitudinal axis and an anvil head pivotally coupled to the anvil center rod and movable between a first operative condition and a second tilted condition. The anvil assembly further includes a locking assembly configured to selectively lock the anvil head in each of the first and second conditions.

Abstract: A method of sealing a resected surface of an organ includes applying a synthetic matrix to a resected surface of an organ, and applying an adhesive on the synthetic matrix so that the adhesive penetrates through interstices of the synthetic matrix for contacting an interface between the synthetic matrix and the resected surface of the organ. The method includes curing the adhesive for bonding the synthetic matrix to the resected surface of the organ. The synthetic matrix is a non-woven mesh made of polyglactin 910 or any other synthetic or non-synthetic fabric having a similar porosity or density. The adhesive is a biosynthetic or a synthetic adhesive. After penetrating through the pores of the synthetic matrix and curing, the cured biosynthetic or synthetic adhesive mechanically interlocks with the synthetic matrix for adhering the synthetic matrix to the tissue for creating a sealing barrier.

Abstract: Non-woven graft materials for use in specialized surgical procedures such as neurosurgical procedures, methods for making the non-woven graft materials, and methods for repairing tissue such as neurological tissue using the non-woven graft materials are disclosed. More particularly, disclosed are non-woven graft materials including at least two distinct fiber compositions composed of different polymeric materials, methods for making the non-woven graft materials and methods for repairing tissue in an individual in need thereof using the non-woven graft materials.

Abstract: Provided herein are biomimetic osteochondral implants that are generally useful for the at least partial resurfacing of damaged cartilage within a joint. The implants are constructed to have a modular, layered structure in which the physical properties (e.g., stiffness and lubricity) or dimensions of each layer can be adjusted (e.g., by using the appropriate material and controlling the thickness thereof) based on the anatomy to be replaced. For example, the material and or thicknesses of the layers can be selected to approximate the physical properties and/or dimensions of cartilage (and, optionally, chondral and subchondral bone). Also provided herein are methods of treatment involving the use of said biomimetic osteochondral implants to repair an osteochondral defect in a joint.

Abstract: A soft tissue device can incorporate a composite material comprising a gel and at least one nanostructure disposed within the gel. A soft tissue device can further incorporate biologically active materials such as cells, tissues. A method for healing a soft tissue defect while promoting soft tissue regeneration can include applying a soft tissue device to a soft tissue defect, wherein the composite material includes a gel and a nanostructure disposed within the gel. A method for manufacturing a soft tissue device for use in healing soft tissue defects can include providing a gel, disposing nanofibers within the gel, and a biologically active material.

Abstract: An implantable article for attaching tendons and/or ligaments to bone and/or cartilage, assemblies thereof, and methods of use thereof are provided. The article is configured for attaching at least one of a tendon and a ligament to at least one of bone and cartilage. The article comprises a membrane comprising a biological material that promotes cell growth. The membrane comprises a first end, a second end, a cavity, and an expandable portion. The second end is configured to be attached to at least one of the bone, the cartilage, the tendon, and the ligament. The cavity extends from the first end to the second end. The cavity is configured to receive the cell growth mixture from the open end. The expandable portion is positioned intermediate the first end and the second end and is configured to increase in size responsive to the cell growth mixture entering the cavity.

Abstract: Tissue engineering devices and methods employing scaffolds made of absorbable material for use in the human body for tissue genesis and regenerative and cellular medicine including breast reconstruction and cosmetic and aesthetic procedures and supplementing organ function in vivo.

Abstract: This invention relates to compositions and methods for promoting and/or accelerating bone regeneration, repair, and/or healing and, in particular, to compositions and methods of promoting bone regeneration, growth, repair, and/or healing using graft or scaffold materials. In exemplary embodiments, the disclosed compositions may be used to promote and/or accelerate bone regeneration by delivering a composition to a bone site, the composition comprising (a) a citrate component, (b) a phosphate component, and, optionally, (c) a particulate inorganic material. The citrate component and/or phosphate component is advantageously released from the composition at the bone site. The released citrate component may function to increase alkaline phosphatase activity and/or expression at the bone site, and the increased alkaline phosphatase activity and/or expression may release the phosphate component. The composition may be delivered in various forms, e.g., as a biodegradable scaffold.

Abstract: A method for removing amorphous regions from a surface of a crystal substrate uses an accelerated neutral beam including reactive gas species for removing or reactively modifying material surfaces without sputtering. Accelerated neutral atom beam enabled surface reactions remove surface contaminants from substrate surfaces to create an interface region with exposed crystal lattice in preparation for next phase processing.

Abstract: A staple cartridge assembly for use with a surgical stapling instrument includes a staple cartridge including a plurality of staples and a cartridge deck. The staple cartridge assembly also includes a compressible adjunct positionable against the cartridge deck, wherein the staples are deployable into tissue captured against the compressible adjunct, and wherein the compressible adjunct comprises a first biocompatible layer comprising a first portion, a second biocompatible layer comprising a second portion, and crossed spacer fibers extending between the first portion and the second portion.

Abstract: A method and apparatus is provided for creating a modified tissue graft, wherein an anatomical site at which the modified tissue graft is to be placed is identified, desired characteristics for the modified tissue graft are identified based at least upon the anatomical site, one or more types of graft modifications and regions of the tissue graft to be modified are identified to achieve the desired characteristics; and at least a first area and a second area of the exterior surface of the tissue graft are modified by compressing, cutting and/or removing one or more portions thereof to create first designed surface features which cause the tissue graft to have first characteristics in the first area and second designed surface features which cause the tissue graft to have second characteristics in the second area.