Abstract: A small diameter delivery device capable of delivering a tissue loaded scaffold arthroscopically to a tissue defect or injury site without reducing the pressure at the injury site is provided. The scaffold delivery device of the present invention comprises a plunger system that includes two main components: an insertion tube and an insertion rod. The insertion tube has a flared proximal end for holding a tissue scaffold prior to delivery. An elongate, hollow body extends from the flared proximal end to a distal end of the insertion tube, and defines a passageway that extends through the body for delivery of the tissue scaffold. The insertion rod has an elongate body that extends into a handle at a proximal end and a tip at a distal end. The insertion rod is configured to be removably disposed within the insertion tube for sliding along the passageway to effect delivery of the tissue scaffold through the insertion tube.

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 generally relates to nanoscale wires and tissue engineering. In various embodiments, cell scaffolds for growing cells or tissues can be formed that include nanoscale wires that can be connected to electronic circuits extending externally of the cell scaffold. The nanoscale wires may form an integral part of cells or tissues grown from the cell scaffold, and can even be determined or controlled, e.g., using various electronic circuits. This approach allows for the creation of fundamentally new types of functionalized cells and tissues, due to the high degree of electronic control offered by the nanoscale wires and electronic circuits. Accordingly, such cell scaffolds can be used to grow cells or tissues which can be determined and/or controlled at very high resolutions, due to the presence of the nanoscale wires, and such cell scaffolds will find use in a wide variety of novel applications, including applications in tissue engineering, prosthetics, pacemakers, implants, or the like.

Abstract: A modification to allow delivery of a two port medical flow restrictor over a guidewire, and a means to mechanically collapse the new device. A thin walled, foil-like shell, is compacted for delivery. The invention includes the device, delivery assemblies, and methods of placing, and using, the device. A device with an aneurysm lobe and an artery lobe self-aligns its waist at the neck of an aneurysm as the device shell is pressure expanded. Mechanical force collapses both the aneurysm lobe and the artery lobe, captivating the neck of the aneurysm and securing the device. The device works for aneurysms at bifurcations and aneurysms near side-branch arteries. The device, unlike endovascular coiling, excludes the weak neck of the aneurysm from circulation, while leaving the aneurysm relatively empty. Unlike stent-based exclusion, the device does not block perforator arteries. This exclusion device can also limit flow through body lumens or orifices.

Abstract: A modification to allow delivery of a two port medical flow restrictor over a guidewire, and a means to mechanically collapse the new device. A thin walled, foil-like shell, is compacted for delivery. The invention includes the device, delivery assemblies, and methods of placing, and using, the device. A device with an aneurysm lobe and an artery lobe self-aligns its waist at the neck of an aneurysm as the device shell is pressure expanded. Mechanical force collapses both the aneurysm lobe and the artery lobe, captivating the neck of the aneurysm and securing the device. The device works for aneurysms at bifurcations and aneurysms near side-branch arteries. The device, unlike endovascular coiling, excludes the weak neck of the aneurysm from circulation, while leaving the aneurysm relatively empty. Unlike stent-based exclusion, the device does not block perforator arteries. This exclusion device can also limit flow through body lumens or orifices.

Abstract: Described herein are tissue grafts derived from the placental tissue that are reinforced with at least one biocompatible mesh. The tissue grafts possess good adhesion to biological tissues and are useful in wound healing applications. Also described herein are methods for making and using the tissue grafts.

Abstract: Methods, devices and systems facilitate intermittent and/or partial obstruction of a pyloric valve. Devices generally include a support portion for preventing the device from passing through the pyloric valve and a tissue engagement portion for contacting tissue adjacent the pyloric valve to obstruct the valve. Some embodiments also include a positioning member extending from the tissue engagement portion for helping position the device for obstructing the valve. A retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

Abstract: An expandable substantially spherical structure for deployment in a blood vessel or other body lumen, comprising: an open frame formed out of a closed loop of filament and configured to assume (i) a collapsed configuration in the form of a substantially two-dimensional elongated loop structure so as to facilitate insertion into the blood vessel or other body lumen, and (ii) an expanded configuration in the form of a three-dimensional substantially spherical structure so as to facilitate retention at a site in the blood vessel or other body lumen; and a flow-restricting face carried by the open frame; wherein the open frame is configured so as to permit substantially normal flow therethrough when the open frame is in its expanded configuration, and further wherein the flow-restricting face is configured so as to restrict flow therethrough.

Abstract: Methods, devices and systems facilitate intermittent and/or partial obstruction of a pyloric valve. Devices generally include a support portion for preventing the device from passing through the pyloric valve and a tissue engagement portion for contacting tissue adjacent the pyloric valve to obstruct the valve. Some embodiments also include a positioning member extending from the tissue engagement portion for helping position the device for obstructing the valve. A retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

Abstract: Described herein are tissue grafts derived from the placenta that possess good adhesion to biological tissues and are useful in would healing applications. In one aspect, the tissue graft includes (1) two or more layers of amnion, wherein at least one layer of amnion is cross-linked, (2) two or more layers of chorion, wherein at least one layer of chorion is cross-linked, or (3) one or more layers of amnion and chorion, wherein at least one layer of amnion and/or chorion is cross-linked. In another aspect, the grafts are composed of amnion and chorion cross-linked with one another. In a further aspect, the grafts have one or more layers sandwiched between the amnion and chorion membranes. The amnion and/or the chorion are treated with a cross-linking agent prior to the formation of the graft. The presence of the cross-linking agent present on the graft also enhances adhesion to the biological tissue of interest. Also described herein are methods for making and using the tissue grafts.

Abstract: The present invention relates to a filler for removing wrinkles, which comprises: a thin and long tubular main body to be placed so as to penetrate through subcutaneous tissue; and through-holes for guiding tissue cells surrounding the main body into the main body, so as to form fibrous tissue, wherein the through-holes are formed so as to communicate with a hollow portion formed in said main body in the lengthwise direction from the outer surface of said main body. The filler for removing wrinkles according to the present invention is prevented from being deformed or moved by pressure on the skin or by an external force arising after being inserted into the subcutaneous tissue, and can be applied to various body parts having wrinkles, including deep wrinkles. Furthermore, the wrinkle-removing effects of the filler of the present invention may last (semi)permanently.

Abstract: A scaffold for tissue regeneration is provided. In a preferred embodiment, the scaffold is implantable in a patient in need of nerve or other tissue regeneration and includes a structure which has a plurality of uniaxially oriented nanofibers made of at least one synthetic polymer. Preferably, at least 75% of the nanofibers are oriented within 20 degrees of the uniaxial orientation. The scaffold beneficially provides directional cues for cell and tissue regeneration, presumably by mimicking the natural strategy using filamentous structures during development and regeneration.

Abstract: Described, in certain inventive embodiments, are unique devices and methods for introducing implants into soft tissue of a patient. One of these devices includes a tissue-penetrating member that is configured to pass in its entirety through a volume of patient tissue. The tissue-penetrating member has a leading end and a trailing end, and provides a receiving space for receipt of an implant body portion for carrying the implant body portion into the volume of patient tissue. The device also includes an implant that has an implant body portion removably received in the receiving space of the tissue-penetrating member. The implant body portion is configured for deployment from the receiving space in the volume of patient tissue so as to remain deployed there along a passageway traversed by the tissue-penetrating member.

Abstract: A surgical stapler includes first and second tissue clamping members and a knife member. The first tissue clamping member is configured to receive a plurality of staples. The second tissue clamping member comprises an anvil configured to form the staples. A tissue treatment member is positionable between the first and second tissue clamping members. The tissue treatment member comprises a rupturable pouch or baffle that is configured to receive a medical fluid including at least one tissue cell. The tissue treatment member may have a spiral shape, an annular disc shape, or an elongate sleeve shape. The tissue treatment member may also include outwardly extending tabs. The tissue treatment member may also include an injection port. In use, the staples and/or the knife pierce the tissue treatment member to release at least a portion of the medical fluid held by the tissue treatment member.

Abstract: Biocompatible tissue implants are provided for repairing a tissue injury or defect. The tissue implants comprise a biological tissue slice that serves as a source of viable cells capable of tissue regeneration and/or repair. The biological tissue slice can be harvested from healthy tissue to have a geometry that is suitable for implantation at the site of the injury or defect. The harvested tissue slice is dimensioned to allow the viable cells contained within the tissue slice to migrate out and proliferate and integrate with tissue surrounding the injury or defect site. Methods for repairing a tissue injury or defect using the tissue implants are also provided.

Abstract: An osteochondral composite including a hydrogel with implanted biological cells joined to a porous supportive base at a mechanically-interlocked interface is disclosed. A method of fabricating the osteochondral composite and a method of treating damaged or diseased articular cartilage by implanting an osteochondral composite are also disclosed.

Abstract: A parent artery occlusion (PAO) device which provides for immediate occlusion of a cerebral artery to isolate a defect. The PAO device includes a self-expanding wire-frame prolate structure which is partially covered with an ePTFE membrane.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: A tissue-derived hydrogel, as well as methods of making and using such hydrogels, are provided.

Abstract: The drug eluting rolled stent and a stent delivery system, which includes a catheter; a balloon operably attached to the catheter; and a stent disposed on the balloon. The stent includes a rectangular metal foil sheet having a first side and a second side, the rectangular metal foil sheet being rolled to form a cylindrical tube having a central axis and a spiral cross section perpendicular to the central axis; a polymer drug coating disposed between and adhering the first side and the second side; and at least one opening formed through the cylindrical tube generally perpendicular to the central axis, the at least one opening being shaped to form at least one strut having in cross section polymer drug layers between metal foil layers, polymer drug layer edges of the polymer drug layers being in communication with the at least one opening.

Abstract: An implant for repairing a joint between a first bone and a second bone includes a first section constructed of a substantially rigid material and a graft constructed of soft tissue having a first end and a second end. The first section has a first end surface configured for positioning against the first bone. The graft is configured for stabilizing the first section relative to the first bone. A first fastener is configured for mounting to the graft and the first section to anchor the graft to the first section. A second fastener is configured for mounting to the graft and the first bone to anchor the graft to the first bone.

Abstract: A non-absorbable surgical implant for use in the treatment of a vaginal prolapse is provided. The implant includes a knitted mesh having a mass density of less than 25 g/m2. The knitted mesh includes a monofilament, strands formed of the monofilament, major spaces located between adjacent strands and pores located within the strands. A method of treating a vaginal prolapse with a surgical implant is also provided.

Abstract: Macroporous 3-D tissue engineering scaffold comprising elastomeric cross-linked polymer units and interconnected macropores containing living cells are produced by step of: in a mixture of the cells and elastomeric polymer units comprising activatable crosslinking groups, activating the crosslinking groups to form the scaffold.

Abstract: The present invention relates to methods of tissue grafting and microvascular free flap transfer that involve administering a phosphodiesterase type-5 inhibitor to the tissue graft or microvascular free flap to produce a treated graft or flap, and implanting the treated graft or flap into a recipient site of a host subject.

Abstract: Disclosed are tissue graft compositions made of materials having different densities, methods of making, and methods of treatment for restoring tissues in a patient.

Abstract: A method of mending a groinal defect such as an indirect inguinal hernia, a direct inguinal hernia, and/or a femoral hernia. A space between the external oblique aponeurosis and the internal oblique aponeurosis is dissected superiorly and laterally to create a site for receiving a lateral portion of a prosthetic repair patch. Dissection medially and inferiorly between the two aponeuroses leads to a transversalis fascia, which is explored downwardly and, at the pubic bone, dissected to reach the preperitoneal space of Retzius. A medial portion of a prosthetic repair patch may be positioned in the space of Retzius with a lateral portion of the prosthetic repair patch positioned in the dissected space between the two aponeuroses. So positioned, the prosthetic repair patch protects the myopectineal orifice that is susceptible to each of the indirect inguinal hernia, direct inguinal hernia, and femoral hernia.

Abstract: A soft tissue repair implant includes a body having a base section and at least one appendage extending outwardly from the base section. The body is flexible such that the at least one appendage is movable relative to the base section. More particularly, the body is collapsible to a substantially planar configuration, in which the at least one appendage is positioned substantially co-planar relative to the base section. The body is also expandable to a substantially three-dimensional configuration, in which the at least one appendage extends at an angle from the base section. The body is constructed from a single, one-piece sheet such that the at least one appendage is connected to the base section seamlessly without any joint therebetween. A method for making the implant includes the steps of providing a flexible one-piece sheet, making a plurality of cuts in the sheet so as to form the body, and removing portions of the sheet beyond an outer periphery of the body.

Abstract: Disclosed are a gradient bioceramic coating comprising a rare earth oxide, a broadband laser method for preparing the bioceramic coating, and the use of the bioceramic coating in the field of medical materials.

Abstract: A prosthesis for the treatment of hernias and/or laparoceles via an intraperitoneal route, having a mesh of filaments of non-resorbable and biocompatible polymer material having interstices permitting tissue growth and a sheet of polymer material having barrier properties and low adhesion to sensitive organs and tissues. The sheet is superimposed upon and joined to the mesh so as to form a stratified structure. In particular, the sheet is joined to mesh through a plurality of filaments located alongside each other at a spacing of not more than 5 mm. Each filament has a plurality of attachment sites to the mesh which are not more than 15 mm apart, and each length of filament between two successive attachment sites projects from the surface of the mesh facing sheet and is fused to the sheet.

Abstract: A three-dimensional porous scaffold and a preparation method thereof. The three-dimensional porous scaffold comprises a biodegradable multifilament draw-textured yarn on the inside of a tubular knitted fabric made of a biodegradable polymer. The three-dimensional porous scaffold has a porosity formed by the network mesh structure of the tubular knitted fabric and the 10-150 ?m pores formed in the biodegradable multifilament draw-textured yarn, while it has a bulkiness of 150-1000% due to the biodegradable multifilament drawn textured yarn inserted in the tubular knitted fabric. Thus, the scaffold has a high degree of interconnection between pores, so that cell culture, cell delivery or drug delivery on the stable three-dimensional scaffold structure is performed in an optimized manner.

Abstract: Custom moldable cushions for covering medical implants fastened to a bone are provided. Such cushions inhibit irritation of the surrounding soft tissue by covering the bone-implant interface and by reducing friction caused by movement of soft tissue adjacent the implant. Such cushions may also be employed to spread and absorb forces reducing patient discomfort and risk of injury and infection associated with such implants.

Abstract: A method and apparatus for closing a vascular wound includes an apparatus that can be threaded over a guidewire into place at or adjacent the wound. The apparatus includes a chamber that encloses a hemostatic material therein. When the apparatus is positioned adjacent the wound as desired, the hemostatic material is deployed from the chamber. A blocking member distal of the hemostatic material functions as a barrier to prevent the hemostatic material from entering the wound. Blood contacts the hemostatic material, and blood clotting preferably is facilitated by a hemostatic agent within the material. Thus, the vascular puncture wound is sealed by blood clot formation.

Abstract: A pre-rolled surgical mesh which allows its insertion to the abdominal cavity and having a comfortable lead and spread to a proper location. The pre-rolled mesh is double rolled from two opposite directions one toward the other. There is a device that holds, leads, releases and spreads the mesh in its proper location, related to the Hernia defect, and includes an element holds the double-rolled mesh, and allows its releasing; another element allows the spreading of the double-rolled mesh; additional element allows the leading and locating of the double-rolled mesh. A second shape assumed when spreading the mesh, as the center of the mesh matches the desired location, while the elements, which held and spread each side of the double rolled mesh had been released.

Abstract: An extracellular matrix (ECM)-based scaffold suitable for artificial skin as well as other structures can be formed using a bioreactor fabricated with a pattern that introduces desired structural features, on the microscale and/or nanoscale, to ECM-precursors gelled in the bioreactor. The bioreactor can produce a finely patterned scaffold—over clinically relevant size scales—sufficiently robust for routine handling. Preformed ECM-based scaffolds can also have microscale and/or nano-scale structural features introduced into a surface thereof. ECM-based scaffolds may be formed with well-defined structural features via microetching and/or remodeling via ‘contact degradation.’ A surface-activated pattern can be used to degrade the ECM-based scaffold at contact regions between the pattern and the ECM. The produced ECM-based scaffolds can have structures of dimensions conducive to host tissue ingrowth while preserving the fibrous structure and ligand density of natural ECMs.

Abstract: The present invention provides biocompatible composite materials that can be fabricated into a scaffold having properties suitable for bone repair and regeneration. These scaffolds have sufficient mechanical strength to be useful for the repair and regeneration of cortical bone.

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: 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: The invention concerns a method for obtaining a metal implant for open porosity tissue support and/or replacement, characterized in that it comprises the following steps: (i) selecting a mould, (ii) arranging in the mould a solid metal core (7), (iii) filling the volume of the mould (1) still available with a powder of microspheres (3), (iv) consolidating the microspheres (3) with each other as well as with said at least one solid core (7) by electrical discharge sintering.

Abstract: A surgical implant adapted to treat a prolapse in a patient is provided. The implant comprises a knitted mesh having a mass density of less than 25 g/m2. The knitted mesh includes at least one biocompatible polypropylene filament and openings. The implant is configured to be implanted in a region of the prolapse, wherein the prolapse is selected from the group consisting of urethrocoele prolapse, cystocoele prolapse, vault prolapse, uterine prolapse, enterocoele prolapse, and rectocoele prolapse. Methods of using a surgical implant are also provided.

Abstract: An implantable prosthetic mesh for repair of an inguinal hernia. The prosthetic mesh includes a conforming soft mesh portion and two displaced portions each having a three dimensional shape and constructed of a stiffer mesh material. The soft mesh portion can be draped over the tissue and spermatic cords, and the two three-dimensional portions formed from the stiffer mesh material are adapted to enter into and be received deep within the respective space defined in the anatomy at each of direct and indirect spaces surrounding the inferior epigastric vessels.

Abstract: A surgical implant adapted to treat a prolapse is provided. The implant includes a knitted mesh having at least one monofilament, strands formed of the at least one monofilament, major spaces located between the strands and pores located within the strands. Methods of treating a vaginal prolapse with a surgical implant are also provided.

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: An articular cartilage fixation device and method for repairing and regenerating diseased or injured soft tissue such as articular cartilage of the knee, hip, shoulder, and the like. A cartilage flap or cartilage repair device is retained within the chondral or osteochondral defect for a sufficient amount of time such that the cartilage repair device can perform its function and facilitate an appropriate healing response. A plurality of biocompatible anchors are attached to a plurality of flexible members and are shaped to seat into the tissue beneath or near the defect such that the cartilage flap is retained within the defect.

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.

Abstract: A method for making a lightweight surgical mesh, having the steps of applying a first set of filaments in a first wale direction and forming a first series of loops at each of a plurality of courses. Applying a second set of filaments in the first wale direction and forming a second series of loops at a first adjacent wale to the first wale direction and a third series of loops at a second adjacent wale opposite the first adjacent wale along the plurality of courses. Further, applying a third set of filaments in the first wale direction so that the second series of loops are formed at the second adjacent wale and the third series of loops are formed at first adjacent wale along the plurality of courses. Additionally, applying a fourth set of filaments that interlace repeatedly with the first set of filaments along the first wale direction.

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: Described herein are tissue grafts derived from the placenta. The grafts are composed of at least one layer of amnion tissue where the epithelium layer has been substantially removed in order to expose the basement layer to host cells. By removing the epithelium layer, cells from the host can more readily interact with the cell-adhesion bio-active factors located onto top and within of the basement membrane. Also described herein are methods for making and using the tissue grafts. The laminin structure of amnion tissue is nearly identical to that of native human tissue such as, for example, oral mucosa tissue. This includes high level of laminin-5, a cell adhesion bio-active factor show to bind gingival epithelia-cells, found throughout upper portions of the basement membrane.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect including a first composite structure including at least one layer of a non-absorbable material, wherein the first composite structure has a central portion sized and shaped to cover at least a portion of the tissue or muscle wall defect, and has an outer periphery. The prosthesis further includes a second structure having a reinforced central region and an outer peripheral edge, a reinforcing element positioned between the first and second structures, and having an outer periphery and a stiffness greater than that of the first and second structures, and at least one pulling element coupled to the reinforced central region of the second structure. The second structure is coupled to the first structure substantially only at their respective peripheries.

Abstract: Absorbable/biodegradable composite yarns contain at least two types of fibrous components having distinctly different absorption and strength retention profiles and are useful in constructing surgical implants, such as sutures and meshes with integrated physicochemical and biological properties, wherein these properties are modulated through varying the individual yarn content and controlling the geometry of these constructs.

Abstract: Methods and devices for prepping and delivering a biologic construct repair for shoulder and joint surgery into an arthroscopic workspace.