Abstract: Suture delivered patches adapted for interposition, augmentation or repair devices for use in tendon and ligament repair, including rotator cuff repair, have been developed as well as methods for their delivery using suture guided arthroscopic methods. The repair patches may be provided from suitable biocompatible materials. The patches may be delivered using anchored sutures already in use during a surgical repair including, open, minimally invasive, endoscopic, and arthroscopic repair procedures. Additionally, fixation of the suture delivered repair patch is secured along with the normal suture securing workflow of the one or more sutures used to deliver the patch.

Abstract: A bioprinter comprises one or more dispensing units. Each dispensing unit may include (i) a syringe including a hollow body and a plunger dimensioned to translate in the body wherein the body has an exit orifice; (ii) an actuator in contact with a proximal end of the plunger; (iii) a controller for moving the actuator; and (iv) a nozzle having a wall defining a fluid path extending from an inlet of the nozzle to an outlet of the nozzle. The inlet of the nozzle is in fluid communication with the exit orifice of the syringe body. The nozzle includes a fluid passageway in fluid communication with a source of fluid and the fluid path. The bioprinter can be used in a method of preparing microtissue comprising dispensing a bioink from one or more dispensing units of the bioprinter on a plate. The microtissue may comprise cartilage cells or tumor cells or liver cells.

Abstract: The present invention provides a device for occluding an anatomical aperture, such as an atrial septal defect (ASD) or a patent foramen ovale (PFO). The occluder includes two sides connected by a central tube. In some embodiments, the occluder is formed from filaments that are joined together to define a substantially cylindrical form with openings defining struts. Upon the application of force, the struts deform into loops. The loops may be of various shapes, sizes, and configurations, and, in at least some embodiments, the loops have rounded peripheries. The occluder further includes a catch system that maintains its deployed state in vivo. When the occluder is deployed in vivo, the two sides are disposed on opposite sides of the septal tissue surrounding the aperture and the catch system is engaged so that the occluder closes the aperture.

Abstract: Provided is a bioink set for printing a construct that is able to carry cells, including a bioink which contains a biodegradable polyurethane and a biopolymer, and a divalent metal ion solution. The biopolymer is gelatin, agar, alginate salts, hyaluronic acid and salts thereof, chitosan, and any combination thereof. Also provided are a method of preparing a construct for carrying cells by three-dimensional printing with the bioink set, and a method of three-dimensional printing of cells by using an ink composition.

Abstract: Methods of printing a bio-ink on a substrate are provided comprising at least one bio ink layer, said method comprising: i) positioning a printhead comprising a two-dimensional array of print nozzles within proximity of or in contact with a substrate; and ii) ejecting a bio-ink through the print nozzles onto the substrate, forming a bio ink layer, wherein the bio-ink construct comprises at least one bio-ink layer. The methods further encompass methods of printing a live tissue and methods of treating tissue defects.

Abstract: A medical device for repositioning tissue within an animal has a main body with a first end portion, a second end portion, and a middle portion. The first end portion defines a series of passageways and the second end portion defines a bulbous shape, a slot, and a tab portion. Methods of treating obstructive sleep apnea are also described.

Abstract: The present disclosure provides a cell system comprising eukaryotic cells in a hydrogel comprising nanofibrillar cellulose in cell storage medium at a temperature in the range of 0-25° C. The present disclosure also provides a method for storing eukaryotic cells, the method comprising providing eukaryotic cells, providing nanofibrillar cellulose, combining the cells and the nanofibrillar cellulose to form the cell system, and storing the cell system at a temperature in the range of 0-25° C.

Abstract: The present invention relates to the unexpected discovery of 3D printed biomimetics of growth plate cartilage and methods using the same for the treatment of growth plate defects. In certain embodiments, the methods prevent the growth of bony bars at the site of growth plate injury, thereby preventing growth arrest and/or deformity.

Abstract: Aspects of the disclosure relate methods and synthetic scaffolds for regenerating hallow organs present in the respiratory system such as bronchus tissue.

Abstract: A three-dimensional electrospun biomedical patch includes a first polymeric scaffold having a first structure of deposited electrospun fibers extending in a plurality of directions in three dimensions to facilitate cellular migration for a first period of time upon application of the biomedical patch to a tissue, wherein the first period of time is less than twelve months, and a second polymeric scaffold having a second structure of deposited electrospun fibers. The second structure of deposited electrospun fibers includes the plurality of deposited electrospun fibers configured to provide structural reinforcement for a second period of time upon application of the three-dimensional electrospun biomedical patch to the tissue wherein the second period of time is less than twelve months. The three-dimensional electrospun biomedical patch is sufficiently pliable and resistant to tearing to enable movement of the three-dimensional electrospun biomedical patch with the tissue.

Abstract: A hollow fiber that extending along at least a portion of the fiber along a longitudinal axis thereof and is defined by an interior wall is provided. Through selective control over the manner in which it is formed, the present inventors have discovered that the hollow fiber can exhibit a unique combination of a high void fraction and small fiber size that makes it particularly suitable for use in certain applications, such as in nonwoven webs for absorbent articles.

Abstract: Methods of tissue engineering, and more particularly methods and compositions for generating various vascularized 3D tissues, such as 3D vascularized embryoid bodies and organoids are described. Certain embodiments relate to a method of generating functional human tissue, the method comprising embedding an embryoid body or organoid in a tissue construct comprising a first vascular network and a second vascular network, each vascular network comprising one or more interconnected vascular channels; exposing the embryoid body or organoid to one or more biological agents, a biological agent gradient, a pressure, and/or an oxygen tension gradient, thereby inducing angiogenesis of capillary vessels to and/or from the embryoid body or organoid; and vascularizing the embryoid body or organoid, the capillary vessels connecting the first vascular network to the second vascular network, thereby creating a single vascular network and a perfusable tissue structure.

Abstract: An implantable medical device includes an improved tether catch formed by a relatively rigid structure that has a hook surface extending between first and second ends thereof. The second end of the structure is spaced apart from another portion of the device by a gap of a size no greater than a thickness of a tether, for which the tether catch is formed to engage, when the tether is looped within a delivery catheter. The device may be loaded into the catheter by: positioning the looped portion of the tether in close proximity to the gap of the tether catch; creating tension in the positioned tether to bring the looped portion into a perimeter of the hooked surface; and then pulling the tether so that the looped portion thereof bears against the hooked surface, thereby bringing the device into engagement with a distal-most end of the delivery catheter.

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: The present invention provides a pharmaceutical composition for the lubrication of joints, the pharmaceutical composition comprising a non-ionic tonicity agent comprising a polyol, and liposomes comprising at least one membrane comprising at least one phospholipid (PL) selected from a glycerophospholipid (GPL), said GPL having two C12-C18 hydrocarbon chains, being the same or different, and sphingomyelin (SM) having a C12-C18 hydrocarbon chain, the pharmaceutical composition being essentially free of an additional pharmaceutically active agent, wherein the at least one membrane has a phase transition temperature in the range of about 20° C. to about 39° C. and the joint has a joint temperature which is above the phase transition temperature.

Abstract: A composite soft tissue repair material stable in repair area, includes a middle mechanical reinforcement layer containing crosslinked acellular matrix; and upper and lower layers containing non-crosslinked acellular matrix, wherein the upper and lower layers completely encapsulate the middle mechanical reinforcement layer to form a sandwich structure. The present invention combines the advantages of crosslinked acellular matrix and non-crosslinked acellular matrix, including high histocompatibility, no viscera erosion, uniform thickness of the whole material, resistance to infection, long-term mechanical stability of the repair area, et al, which has good application prospects.

Abstract: Provided herein is an isolated decelluarized amniotic membrane (DCM) and methods for using same therapeutically in vivo and in vitro. In one aspect, the isolated DCM is further processed, freezing, freeze drying, lyophilization micronized into powder or treatment with pepsin to create a hydrogel.

Abstract: A method for producing sterile, decellurized bioprosthetic tissue comprising: (a) contacting a human tissue with a hypotonic solution to produce a lysed tissue, (b) contacting the lysed tissue with a first surfactant to produce a surfactant-treated tissue, (c) contacting the surfactant-treated tissue with a nuclease enzyme solution to produce an enzyme-treated tissue, (d) contacting the enzyme-treated tissue with a cleaning solution comprising a second surfactant, a chaotropic agent or a mixture thereof to produce a decellurized tissue and (e) contacting the decellurized tissue with a bioburden reducing agent to produce the final bioprosthetic tissue. Kits to be used in conjunction with said method, as well as, the bioprosthetic tissue produced via said method are also provided.

Abstract: A method for producing a metal nanoparticle-loaded biopolymer microgel involving the reduction of metal ions in a metal ion-loaded biopolymer microgel. The method yields a metal nanoparticle-loaded biopolymer microgel. Also disclosed is a method of catalytically reducing an organic pollutant in water using the metal nanoparticle-loaded biopolymer microgel and a reducing agent.

Abstract: Articles are provided, including a porous elastomeric material having a first major surface and an elastomeric material integrated into the first major surface of the porous elastomeric material. The elastomeric material coating the first major surface, a first portion of the elastomeric material being disposed within a plurality of pores defined by the first major surface of the porous elastomeric material and extending into the plurality of pores to a depth of at least 300 micrometers (?m), wherein the first portion of the elastomeric material provides fluid communication through the porous elastomeric material via holes formed in the elastomeric material extending into the thickness of the porous elastomeric material through the voids of the pores of the elastomeric material. A method of making an article is also provided.

Abstract: Methods and compositions for preparing and priming a tissue graft for an accelerated therapeutic effect are provided herein. In one embodiment, the method includes obtaining a tissue containing viable cells from a donor, wherein the viable cells are endogenous to the tissue and remain resident in the tissue; and priming the viable cells with one or more stimuli to produce a primed tissue, wherein when grafted to a recipient the primed tissue provides a benefit compared to non-primed tissue.

Abstract: Embodiments of the presently disclosed subject matter provide biomimetic cell culture substrates comprising highly tunable patterned polymer nanofiber matrices capable of modulating expression of critical self-renewal factors and markers of cell-cell interaction to maintain stemness of human mesenchymal stem cells in vitro. Embodiments of the presently-disclosed subject matter also provide scalable, highly repeatable methods of making biomimetic cell culture substrates by hot pressing thermoplastic polymer films into femtosecond laser-ablated nanopore molds to form patterned polymer nanofiber matrices on flat thermoplastic substrates.

Abstract: The present disclosure relates to in situ tissue engineering, more specifically in situ vascular tissue engineering with the aim of providing a tissue structure which can be used e.g. as a substitute blood vessel or as a blood vessel functioning as cannulation site in hemodialysis. In particular, the disclosure involves tissue structure formation around a subcutaneously implanted synthetic rod. In addition, the disclosure involves a method for producing said synthetic rod.

Abstract: The present invention provides systems and methods for the decellularization and recellularization of tissue segments. In certain instances the invention comprises coating or sealing decellularized tissue segments with a cross-linked alginate hydrogel. The present invention also provides a decellularization kit, which may be used to generate decellularized tissue segments for high throughput studies. Also included are compositions and methods of tissue sealants comprising methacrylated alginate.

Abstract: An antibiotic-eluting article for implantation into a mammalian subject, produced by an additive manufacturing process wherein a polymeric material is concurrently deposited with a selected antibiotic. The additive manufacturing process may be a fused deposition modeling process, a selective laser sintering process, a selective heat sintering process, a digital light processing process, or a stereolithography process. The antibiotic-eluting article may be temporary or permanent orthopaedic skeletal component, an orthopaedic articulating joint replacement component, and/or an external hard-shell casing for an implantable device. One or more bone-growth-promoting compositions may be concurrently deposited with the polymeric material.

Abstract: A biological construct for the repair and replacement of damaged connective tissue is provided. Methods of repairing or otherwise replacing connective tissue are also provided.

Abstract: A cell-support matrix having narrowly defined uniformly vertically and non-randomly organized porosity and pore density and a method for preparation thereof. The matrix suitable for preparation of cellular or acellular implants for growth and de novo formation of an articular hyaline-like cartilage. A gel-matrix composite system comprising collagen-based matrix having a narrowly defined porosity capable of inducing hyaline-like cartilage production from chondrocytes in vivo and in vitro.

Abstract: A percutaneous transseptal surgical implantation method for replacing a defective atrioventricular (AV) valve with a conical shaped prosthetic valve formed from extracellular matrix (ECM) tissue. When the method is employed to replace a native mitral valve, the method positions the prosthetic tissue valve in the mitral valve region, whereby the valve does not obstruct the outflow tract of the aortic valve and prevents the leaflets of the aortic valve from coapting.

Abstract: Suture delivered patches adapted for interposition, augmentation or repair devices for use in tendon and ligament repair, including rotator cuff repair, have been developed as well as methods for their delivery using suture guided arthroscopic methods. The repair patches may be provided from suitable biocompatible materials. The patches may be delivered using anchored sutures already in use during a surgical repair including, open, minimally invasive, endoscopic, and arthroscopic repair procedures. Additionally, fixation of the suture delivered repair patch is secured along with the normal suture securing workflow of the one or more sutures used to deliver the patch.

Abstract: A tissue adhesive with healing promotion properties formed from a mixture of natural polymers and an activating agent that enhances the adhesive properties of the natural polymer mixture is described. Use of an activating agent and a combination of the natural polymers is unique. The natural polymer tissue adhesive may be useful as a post-operative application for tonsillectomy or adenoidectomy surgery, as an internal tissue adhesive for surgery or wound repair or for application to a burn or skin donor site. For internal use, an optional treatment to improve resistance of the activated adhesive to body fluids is also described. The adhesive described not only functions as an adhesive but would also serve as a protective barrier when applied to surgery or skin sites. In addition, the natural polymers would promote healing due to the inherent properties of the polymers selected.

Abstract: Methods of making tissue fillers are provided. In certain embodiments, the tissue is flake-like and has regenerative properties.

Abstract: In some embodiments, the present disclosure pertains to a method of fabricating an artificial heart muscle (AHM) patch. In some embodiments, the method includes obtaining and/or isolating cells from a subject. In some embodiments, the cells are primary cardiac cells. In some embodiments, the method further includes forming a scaffold. In some embodiments, the method includes seeding the cells in the fibrin gel scaffold. In some embodiments, the method includes culturing the cells seeded in the fibrin gel scaffold under conditions appropriate for the formation of an artificial heart muscle (AHM) patch.

Abstract: A mastopexy implant for maintaining the breast in an elevated and aesthetically pleasing position includes a lower pole support comprising end portions which may be affixed to the chest wall or to a previously installed upper suspension strut. The implant is loaded in an insertion device. The insertion device is inserted through a small incision and into a subcutaneous pocket created in an inferior half of the breast. The lower pole support may have various constructs and in one embodiment includes a unitary conformable mesh having a plurality of arm or band members which are attached across the breast parenchyma and to the chest wall.

Abstract: A laminate useful as a component of a medical implant, for example, useful as a component of an inflatable tissue expander. The laminate includes a base layer, an intermediate layer, and a top layer. When used as a component of a tissue expander, the laminate enables an internal chamber pressure of about 2.5 psi with an expander exterior compressive force of about 40 lbs.

Abstract: A biocompatible tissue graft is provided. The tissue graft includes an extracellular matrix patch and a means for reinforcing the patch.

Abstract: A tissue expansion device with a plurality of lobes made from non-compliant material, each lobe defining a chamber therein. Each chamber is fluidly isolated from every other chamber in the plurality of lobes. Each chamber has an inflation element with a valve to release a pressurized fluid to inflate the lobe to expand a cavity, and a deflation element with a valve to deflate the lobe by compressing the fluid.

Abstract: The present disclosure relates to a three-dimensional, degradable medical implant for regeneration of soft tissue comprising a plurality of volume-building components and a mesh component which is substantially made of monofilament or multifilament fibers, wherein each volume-building component is attached to at least one point on a surface of the mesh component, and wherein the projected surface area of each volume-building component, when projected on the surface of the mesh component, corresponds to a maximum of one tenth of the surface area of the mesh component.

Abstract: The present invention relates to a prosthesis (200) comprising: one mesh (1) delimited by a peripheral exterior edge (1a), a frame (2) fastened to said mesh and adopting the shape of said peripheral exterior edge of the mesh, said frame being set back from said peripheral exterior edge and being provided with two hinge points (3a, 3b), the line passing through said two hinge points also passing through the centre (1b) of the mesh and thus forming a line M for folding the mesh in two, characterized in that said prosthesis further comprises at least two anchor pieces (5) made of suturable material and located on a single face of the mesh (1) on either side of said folding line, each piece having a fixed part (5a) linked to said mesh and a free part (5b), said free part being linked to at least one thread-shaped element (7).

Abstract: Biocompatible biomimetic materials that exhibit desirable mechanical properties while also encouraging cell ingrowth and proliferation are described. The biomaterials include a multi-layer laminate of three or more decellularized aligned collagen tissues. The individual layers are aligned with one another in an angle-ply arrangement, with the collagen of each layer aligned at an angle to the collagen of the adjacent layer. The biomaterials are useful as collagenous graft materials such as a patch for a hernia in an annulus fibrosus or grafting materials for repair of tendons, ligaments, cartilage and other musculoskeletal tissues.

Abstract: Various aspects of the disclosure pertain to blood vessel occlusion devices having a central longitudinal axis and comprising: (a) a hub, (b) a self-expanding support frame comprising a plurality of wire segments forming a plurality of cells, and (c) a covering material covering cells within the transition portion. The support frame may be self-expandable from a constrained shape to an unconstrained shape that comprises (ii) a substantially cylindrical portion having a diameter and an axis that is coincident with the central longitudinal axis, the substantially cylindrical portion comprising a first ring of the cells extending in a 360° rotation around the central longitudinal axis and (ii) a transition portion disposed between the substantially cylindrical portion and the hub. Other aspects for the disclosure pertain to assemblies, kits and methods that employ such devices.

Abstract: The present invention relates to a method for culturing bone marrow cells, in which bone marrow cells are applied to a porous polyimide film and cultured. Moreover, the present invention relates to a porous polyimide film for healing a bone injury site.

Abstract: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Abstract: Methods to produce perforated collagen coated meshes for use as implants have been developed. The method involves positioning needles through the pores of the mesh, coating the mesh with a collagen solution, freezing the coated mesh, removing the needles from the frozen coated mesh, drying the collagen coated mesh, and optionally cross-linking the coated mesh. The method allows perforated collagen coated meshes to be prepared with variable thickness, and without damage to the surface of the mesh. The perforations of the collagen coated meshes may be designed to prevent the formation of fluid pockets when the coated meshes are implanted, and to permit rapid incorporation into host tissue. The perforated collagen coated meshes may be used for soft tissue repair, regeneration or remodeling including, for example, hernia repair, mastopexy, treatment of urinary incontinence, pelvic floor reconstruction, and ligament and tendon repair.

Abstract: The invention is to articles made from extracellular matrix sheets that encase biodegradable polymeric material. Methods of healing wounds or regenerating tissue at sites of defect by placing said articles in mammals are claimed. The biodegradable polymer can change quality upon contact with a physiological parameter such as temperature or pH that causes, for example, a liquid polymer to gel or harden. The degradation of the polymer can be controlled to suit a tissue regeneration or wound healing time course. Additional components such as proteins, cells and drugs can be added to the biopolymer composition.

Abstract: A device for the reconstruction of the rotator cuff including a flat element having at least two opposite ends and adapted to be connected to at least one of the damaged tendons of the rotator cuff of a patient at the ends; the flat element being entirely made of biodegradable and resorbable material.

Abstract: An implantable mesh for use in reconstructing tissue includes a mesh body and one or more extensions extending from the mesh body. Each mesh extension has a first end and a second end, wherein the first end of the mesh extension is integrated into or part of the mesh body. Each mesh extension is configured to permit multiple anchor points with surrounding tissue upon implantation. In one embodiment, a fixation device is at the second end of each mesh extension. Methods of using the implantable mesh are also provided.

Abstract: Disclosed are composite implantable tissue attachment devices comprising a mechanical reinforcing component and a cellular scaffold component. Disclosed devices include a wide, relatively flat portion for supporting long term repair of tissue. Disclosed devices can include a tapered portion at the end of the wide portions that can lead into a narrower elongated extension for aiding in placement of the device during a surgical procedure. The wide portion of the device can provide tensile strength along the longitudinal axis of the device as well as porosity. The wide devices can cover a larger surface area of a delivery site than standard suture. Disclosed materials can be utilized in, e.g., soft tissue repair such as tendon and ligament reconstruction and repair.

Abstract: A staple cartridge assembly is disclosed which comprises a cartridge body and an implantable layer. The implantable layer includes fibers comprised of a first material and a second material. The first material and the second material have different glass transition temperatures. After the fibers comprised of the first material and the second material have been intermixed or interwoven, the layer is exposed to a temperature which exceeds the lower of the two glass transition temperatures. This heating process causes the layer to constrict and increase in thickness. The layer, when implanted, can compensate for variations in tissue thickness within the staples.

Abstract: An implantable prosthesis for mending anatomical defects, including a groin hernia. The prosthesis includes a prosthetic repair patch that may be implanted in different tissue planes to mend a defect. The patch may include a medial portion configured to be positioned in a first tissue plane and a lateral portion configured to be positioned in a second tissue plane offset from the first tissue plane. The patch may include a transition region configured to extend through tissue and/or muscle, such as fascia, separating the tissue planes and transition the patch from one tissue plane to the other tissue plane. The transition region may be configured to inhibit buckling and/or bunching of the patch when implanted through the fascia. The lateral portion of the patch may have a level of stiffness that facilitates implantation of the patch in different tissue planes while inhibiting patient sensation to the implanted patch.

Abstract: Herein disclosed is a tissue supplied in a configuration pre-shaped to the topography of the recipient surface for covering defects in the articulating surfaces of bones. Also discussed herein is a method of preparing a graft for reconstruction of a defect in an articular surface of a bone comprising determining the topography of the native articular surface and the corresponding underside of the cartilage layer; fabricating a pair of mating surfaces having the topography of the native articular surface and the underside of the cartilage layer; harvesting a cartilage graft from a cadaveric donor; and placing said graft between the mating surfaces and subjecting said graft to sufficient pressure for a sufficient duration to cause it to change shape to that of the deforming surfaces.