Compositions including a first soft tissue-derived matrix and a second soft tissue-derived matrix are provided, as well as methods of making such compositions. In some embodiments, the composition comprises delipidated, decellularized adipose tissue-derived matrix and delipidated, decellularized fascial tissue-derived matrix, which may be combined in various proportions. Such adipose-fascia matrix compositions provide improved volume retention when implanted into a patient. The composition may further include exogenous cells or other substances, and/or a carrier. The composition is suitable for use in plastic surgery procedures, including reconstructive or cosmetic surgery procedures, as well as procedures for wound treatment and tissue regeneration. The methods for making the compositions may involve separation of first and second soft tissues from one another, followed by performing one or more treatments on the separated soft tissues, then combining the treated soft tissues and, optionally, performing one or more additional treatments on the combined soft tissues.
Methods for making surgical implants (or grafts) comprising tissue-derived pieces derived from cartilage, dermis, placenta, and combinations thereof, and which are shaped using a container or mold, or by compressing the tissue-derived pieces, into a first shape, including but not limited to a cylinder, a plug, or a sheet, and possibly also a secondary shape such as when the first shape is a sheet. Prior to shaping the tissue-derived pieces have one or more physical forms selected from fibers, flakes, particles, and powder. The implants are at least partially crosslinked by exposure to UV radiation, whereby the implants retain the first shape, as well as the secondary shape when present, when rehydrated, when compressed or subjected to cyclical loading. The implants stay in one piece and do not disperse when subjected to a load, during and after rehydration, during irrigation, or when placed in an aqueous environment.
Decellularized muscle matrices are provided for use as implants and grafts to repair, regenerate, supplement, reinforce and replace muscle tissue. The decellularized muscle matrices are derived from muscle tissue having preserved extracellular matrix components, retained muscle-forming potential, and from which immunogenic components have been removed. The decellularized muscle matrices are produced in various physical forms and combinations. Methods for making and using the decellularized muscle matrices are also provided.
Volumizing grafts useful for plastic and reconstructive surgery, especially those involving replacement or enhancement of tissue mass and volume. The volumizing graft includes a sheet shaped body made of a biocompatible material which forms, or is capable of forming, a shape having a cavity for receiving, holding, containing, etc., one or more additional components. Either or both of the sheet shaped body and additional components may be bioactive. Either or both of the sheet shaped body and additional components may comprise tissue derived matrices. The sheet shaped body of the volumizing graft enables the additional components to be positioned, oriented, affixed, or some combination thereof, in or proximate to a treatment site, either permanently or temporarily. This may allow subsequent removal, repositioning, replacement, supplementing, or a combination thereof, of the additional components, at the treatment site.
A multi-component packaging system capable of holding a graft and fluid therein, and which enables separation and removal of fluid from the graft, hydration of the graft by adding fluid, or both, while the graft is held in the packaging system. The packaging system comprises: a graft holding region for holding the graft and, optionally, a fluid; a reservoir region for receiving and containing fluid separated from the graft; a container configured to hold the graft, prevent contamination, and which defines the reservoir region. The packaging system further comprises: at least one fluid separation feature for enabling separation of fluid from the graft; at least one compression feature for applying compressive force to assist with more efficient separation of fluid from the graft and displacement of separated fluid from the graft holding region and into the reservoir region, and at least one fluid communication means which allows displaced fluid to leave the graft holding region and enter the reservoir region.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A61L 27/36 - Materials for prostheses or for coating prostheses containing ingredients of undetermined constitution or reaction products thereof
9.
SHAPED AMALGAMATED CARTILAGE GRAFTS AND METHODS FOR MAKING AND USING SAME
Shaped amalgamated cartilage grafts having predetermined three-dimensional shapes are provided which are formed from a plurality or population of cartilage derived pieces (e.g., particles, fibers, fragments, etc.) by any one or more manufacturing and processing techniques including additive manufacturing (e.g., 3-D printing), stereolithography, molding, casting, extrusion, molding or shaping followed by dehydration, and any 3-D formation technique capable of converting the plurality of cartilage derived pieces into a shaped amalgamated cartilage graft having a predetermined 3-D shape which is maintained after hydration of the graft. Additional processing techniques and material properties may contribute to or increase cohesiveness of the plurality of cartilage particles to hold or maintain the predetermined 3-D shape including, inherent or enhanced entanglement of elongated cartilage particles or fibers, curing, cross-linking (thermal, chemical, UV, etc.), hydrostatic forces, surface tension, intermolecular forces, and combinations thereof.
Allografts for soft tissue repair, including breast reconstruction and other plastic surgery procedures, are disclosed. In an exemplary embodiment, first and second cuts are made into the reticular layer of a skin sample to separate an improved acellular dermal matrix (ACDM) which forms a dermal tissue form useful as a graft. The dermal tissue form consists essentially of reticular dermis and has a first exposed surface formed by reticular dermis, an opposite second exposed surface formed by reticular dermis, and has substantially uniform density and uniform porosity between the first and second exposed surfaces, which allows and promotes rapid and efficient cellular ingrowth and tissue ingrowth substantially equally from either the first or second exposed surfaces upon implantation.
A cutting device is provided for resizing a tissue sample by enabling a user to make controlled, precise, and consistent cuts into and through the tissue sample. The device includes a body which is assembled from a base plate, a top plate. The base plate has a recess on its surface, and a tissue cavity extending further down within the recess. Tightening thumb screws provided at opposite ends of the body causes the top plate to apply downward pressure on a tissue sample received and held in the tissue cavity. Front and back slots oriented in alignment with one another are provided through front and back walls, respectively, of the base plate. The slots receive a blade therethrough and guide movement of the blade to perform controlled, precise and consistent cutting of the tissue sample placed in the cavity. Methods of using the cutting device are also provided.
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Facilitating and coordinating recovery and transfer of human biological tissue for medical research purposes by communicating needs and criteria between medical research institutions and organ procurement organizations and then arranging for recovery of the matching tissue
Allografts for soft tissue repair, including breast reconstruction and other plastic surgery procedures, are disclosed. In one embodiment, two allografts are produced from the same decellularized dermal tissue, each of which consists essentially of reticular dermis, and comprises a collagen matrix having substantially uniform density and porosity.
Elongated, curled cartilage fibers and shaped implants comprising them are disclosed, as well as methods for making and using them. A cohesive mass of intertwined cartilage fibers may be shaped to provide a shaped implant which conforms to an implant site. The implant may also be reshaped to have a second shape which conforms to an implant site. The implant site may be the cavity of a cartilage defect, or a space or pocket at a treatment site, any of which may have resulted from treatment, injury, or disease. The implant may be shaped or reshaped to conform to, or replace, an anatomical feature or portion thereof, for repair or treatment of the anatomical feature. Shaped implants comprising the cartilage fibers have good shape retention and are capable of completely filling, and resisting migration from, an implant site after administration and hydration.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Human allograft tissue; human allograft tissue comprised of
adipose matrix; human allograft tissue derived from adipose
matrix; adipose cavity filler; soft tissue implant for use
in surgery.
17.
COMPOSITE GRAFT INCLUDING A BIOSTIMULATIVE TISSUE DERIVED COMPONENT AND METHODS FOR MAKING AND USING SAME
A structurally enhanced composite graft is provided which comprises: at least one mechanical reinforcement component ("MRC") and at least one biostimulative tissue derived component ("BTC"). The composite graft may have a desired selected geometry matching the body feature or portion thereof to be treated. The BTC provides biostimulation capable of facilitating or enhancing healing, and endogenous tissue remodeling or new formation. The MRC provides increased mechanical strength for load bearing grafts and applications, increased mechanical strength for shape retaining grafts useful in reconstruction and repair. Production methods comprise one or more reformative manufacturing processes such as, without limitation, molding, reforming, reshaping, additive manufacturing (three dimensional or 3-D printing), coating, and filling, thereby combining the BTC with, on, around, or within the MRC. In an exemplary embodiment, a composite interbody spacer comprising at least one MRC is produced by 3-D printing using bioink comprising a reduced size bulk biostimulative tissue derived material.
A multi-component packaging system comprising at least a first component, e.g., a primary container, which is configured to hold a graft and prevent contamination, enable lyophilization and later rehydration of the graft while in the packaging, as well as enabling and facilitating separation and removal of fluids from the graft and packaging, while the graft remains in the packaging. Exemplary primary containers include: a graft holding region for holding the graft and, optionally, a fluid; a fluid separation feature for enabling separation of fluid from the graft; and a reservoir region for receiving and containing fluid separated from the graft. The primary containers further include a compression feature for applying compressive force to assist with more efficient separation of fluid from the graft and displacement of separated fluid from the graft holding region and into the reservoir region.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Methods are provided for treatment of several conditions of one or more body features, where the method comprises implanting an acellular soft tissue-derived matrix in, on, proximate to, or a combination thereof, the body feature, wherein the acellular soft tissue-derived matrix comprises a delipidated, decellularized adipose matrix. The delipidated, decellularized adipose tissue matrix is produced by delipidating an adipose tissue sample, followed by decellularizing the delipidated adipose tissue sample. The resulting matrix contains a proportion of lipids which is less than the proportion of lipids contained in a matrix produced by decellularizing an adipose tissue sample prior to delipidating. The delipidated, decellularized adipose matrix may be provided as particles, a slurry, a paste, a gel, an injectable form, or in some other form.
Volumizing grafts useful for plastic and reconstructive surgery, especially those involving replacement or enhancement of tissue mass and volume. The volumizing graft includes a sheet shaped body made of a biocompatible material which forms, or is capable of forming, a shape having a cavity for receiving, holding, containing, etc., one or more additional components. Either or both of the sheet shaped body and additional components may be bioactive. Either or both of the sheet shaped body and additional components may comprise tissue derived matrices. The sheet shaped body of the volumizing graft enables the additional components to be positioned, oriented, affixed, or some combination thereof, in or proximate to a treatment site, either permanently or temporarily. This may allow subsequent removal, repositioning, replacement, supplementing, or a combination thereof, of the additional components, at the treatment site.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Grafts modified with one or more bioactive substances are provided, as well as methods to make and use them. More particularly, the present invention relates to modified grafts having characteristics which facilitate tissue generation, repair, and reconstruction, and which are modified with bioactive substances, such as one or more proteins and minerals, whose bioactivity further facilitates tissue generation, repair, and reconstruction. Methods for producing the modified grafts include depositing the one or more bioactive substances onto, into, or both, a substrate material. In certain exemplary embodiments, the substrate material comprises a tissue derived matrix produced by processing one or more tissue samples, and the bioactive materials are precipitated from a solution produced during that processing, such as during demineralization of bone tissue samples or delipidation of adipose tissue samples, wherein the one or more bioactive substances comprise proteins and minerals endogenous to bone or adipose tissue, respectively.
Compositions including a first soft tissue-derived matrix and a second soft tissue-derived matrix are provided, as well as methods of making such compositions. In some embodiments, the composition comprises delipidated, decellularized adipose tissue-derived matrix and delipidated, decellularized fascial tissue-derived matrix, which may be combined in various proportions. Such adipose-fascia matrix compositions provide improved volume retention when implanted into a patient. The composition may further include exogenous cells or other substances, and/or a carrier. The composition is suitable for use in plastic surgery procedures, including reconstructive or cosmetic surgery procedures, as well as procedures for wound treatment and tissue regeneration. The methods for making the compositions may involve separation of first and second soft tissues from one another, followed by performing one or more treatments on the separated soft tissues, then combining the treated soft tissues and, optionally, performing one or more additional treatments on the combined soft tissues.
Diversified grafts suitable for use in repair and reconstruction procedures are provided. Some diversified grafts comprise two or more heterogenous features which form regions having different preferred properties. A diversified graft useful for pre-pectoral breast reconstruction, meshing is provided on an upper pole of the diversified graft and a plurality of slits arranged in particular patterns is provided on a lower pole of the graft, whereby the upper pole has a greater expansion ability and the lower pole has lesser degree of expansion ability but maintains greater load bearing capacity which is necessary to support the lower pole of the breast undergoing reconstruction, while allowing for fluid egress. In other embodiments, the diversified graft comprises two or more components which are combined by attaching them to each other to form a larger graft of the required size. The components may be smaller pieces of the same material or different materials.
Diversified grafts suitable for use in repair and reconstruction procedures are provided. Some diversified grafts (10) comprise two or more heterogenous features (118a, 118b) which form regions having different preferred properties. A diversified graft useful for pre-pectoral breast reconstruction, meshing is provided on an upper pole of the diversified graft and a plurality of slits arranged in particular patterns is provided on a lower pole of the graft, whereby the upper pole has a greater expansion ability and the lower pole has lesser degree of expansion ability but maintains greater load bearing capacity which is necessary to support the lower pole of the breast undergoing reconstruction, while allowing for fluid egress. In other embodiments, the diversified graft comprises two or more components which are combined by attaching them to each other to form a larger graft of the required size. The components may be smaller pieces of the same material or different materials.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
A device for separating a sample of tissue in a controlled and precise manner and, more particularly, to produce a piece of tissue having a generally planar configuration and, optionally, additional desired characteristics, such as a predetermined maximum thickness, and selected tissue type. The device is adjustable to allow for different thicknesses and different operational speeds for application to different types of recovered tissue samples.
Multiple component grafts are provided for treatment of tissue defects and comprise two or more components, each of which is a tissue-derived matrix and at least two of which are derived from different types of tissue. For example, a first component may be a matrix derived from cartilage tissue such as cartilage fibers with or without viable cells, cartilage particles with or without viable cells, or combinations of any two or more such cartilage-derived matrices. A second component may be a matrix derived from bone tissue such as mineralized or demineralized cortical bone fibers, viable cancellous bone matrix (e.g., cryopreserved or lyophilized chips, particulates, powder, sheets, putty, flowable fluid, etc.), demineralized or demineralized cancellous bone matrix (chips, particulates, powder, sheets, putty, flowable fluid, etc.), or combinations of any two or more of such bone-derived matrices. Also provided are methods for making and using such multiple component grafts.
Preserved tissue samples contain endogenous viable cells and retain or promote biological activity after being stored at temperatures above freezing for extended periods of time (e.g., from 14 days to 3 years). The preserved tissue samples are implanted in or on a subject and, after rehydration, they retain beneficial biological activity, promote beneficial biological activity, or both. The beneficial biological activity comprises promoting one or more of tissue healing, tissue growth, and tissue generation. Methods for preparing the preserved tissue samples include contacting a recovered tissue sample with one or more protectants, followed by lyopreservation. Suitable protectants include sugars, polyphenols, carotenoids, and combinations thereof. Preferred protectants include glucose, fructose, sucrose, trehalose, dextran, EGCG, and combinations thereof. The recovered tissue sample may be any of several possible issue types. In preferred embodiments, the recovered tissue samples are selected from bone, placental, cartilage and combinations thereof.
Methods for making surgical implants (or grafts) for the repair of bone defects, and more particularly, surgical implants that include demineralized bone fibers, are disclosed. Also disclosed are methods for increasing the wettability and ensuring uniform density of such implants. The surgical implants have a wettability time of less than 5 minutes and a residual moisture content of less than 6% by weight, and they remain cohesive and retain their shape upon complete rehydration.
A tissue derived implant is provided having a configuration which is sized and shaped to be disposed within a reservoir of a handling or storage device, the implant having one or more liquid dispersion features for enabling effective hydration of the implant when the implant is disposed in the reservoir and contacted with a biocompatible liquid. The liquid dispersion features form at least one liquid pathway which facilitates collecting and distributing the biocompatible liquid to contact the substantially the entire implant. An implant assembly is also provided which comprises a handling or storage device comprising an elongated reservoir with the tissue derived implant disposed therein. Additionally, an implant kit is provided which comprises a handling or storage device with an elongated reservoir and the tissue derived implant having an elongated configuration sized and shaped to allow the implant to be disposed in the elongated reservoir at the time of use.
Tissue derived porous matrices for treating wounds are provided, as well as methods for making and using them. The tissue derived porous matrices comprise processed tissue of any of several types, such as dermis, adipose, etc., and have a plurality of interconnected pores which allow fluid flow through the matrices. The tissue derived matrices are biocompatible resorbable matrices which remodel with native tissue and facilitate and enhance cell infiltration and tissue ingrowth into the matrices during the wound healing process, thereby enhancing wound healing and tissue remodeling when implanted into a patient. The tissue derived matrices are useful with reduced or negative pressure wound healing methods and systems, without the need to repeatedly revisit the treatment site and remove previously implanted matrices.
A61L 27/36 - Materials for prostheses or for coating prostheses containing ingredients of undetermined constitution or reaction products thereof
A61L 15/40 - Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof
A61L 15/42 - Use of materials characterised by their function or physical properties
A61L 27/54 - Biologically active materials, e.g. therapeutic substances
A61M 1/00 - Suction or pumping devices for medical purposesDevices for carrying-off, for treatment of, or for carrying-over, body-liquidsDrainage systems
The disclosure provides implants containing a plurality of particles containing at least one population of viable cells adherent to and resident in soft tissue matrix or at least one viable population of cells caused to be in contact with the soft tissue matrix; methods of fabricating the implants; and use of the implants in tissue repair.
Methods are provided for treatment of several conditions of one or more body features, where the method comprises implanting an acellular soft tissue-derived matrix in, on, proximate to, or a combination thereof, the body feature, wherein the acellular soft tissue-derived matrix comprises a delipidated, decellularized adipose matrix. The delipidated, decellularized adipose tissue matrix is produced by delipidating an adipose tissue sample, followed by decellularizing the delipidated adipose tissue sample. The resulting matrix contains a proportion of lipids which is less than the proportion of lipids contained in a matrix produced by decellularizing an adipose tissue sample prior to delipidating. The delipidated, decellularized adipose matrix may be provided as particles, a slurry, a paste, a gel, an injectable form, or in some other form.
A ligament-derived graft is provided which comprises a portion of a ligament sample recovered from a mammalian donor and which has been cut approximately in half lengthwise, where the ligament derived graft has dimensions suitable for use in a surgical procedure to repair small to mid-sized, or less load bearing joints. Small joints for which the ligament-derived grafts may be used to repair, include, interphalangeal, metacarpophalangeal joint, scapholunate joint, and other joints. In some embodiments, the dimensions of the ligament-derived graft include a length of from about 50 mm to about 150 mm, and a width of from about 3 mm to about 20 mm. In some embodiments, ligament samples used to make the ligament-derived grafts are lateral or medial collateral ligaments. Methods of using such ligament-derived grafts include attaching one or more ligaments, at their ends, to bones on opposite sides of the joint being repaired, so that the ligament(s) extend across the joint. When two grafts are used, they may extend across the joint, either on the same or opposite lateral sides of the joint.
Decellularized muscle matrices are provided for use as implants and grafts to repair, regenerate, supplement, reinforce and replace muscle tissue. The decellularized muscle matrices are derived from muscle tissue having preserved extracellular matrix components, retained muscle-forming potential, and from which immunogenic components have been removed. The decellularized muscle matrices are produced in various physical forms and combinations. Methods for making and using the decellularized muscle matrices are also provided.
Provided herein are compositions and methods for treating heart disease. In particular, provided herein are constructs, devices, and systems, each comprising one or more placenta-derived compositions, and their use in treating disorders involving aberrant cardiac rhythms and promoting repair of damaged cardiac tissue. The method of treatment comprises applying one or more constructs on the surface of all or a portion of the heart and/or adjacent tissues, during or after surgical heart treatment.
A61P 9/10 - Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Human allograft tissue; human allograft tissue for topical use comprised of tissue from placental membranes; human allograft tissue derived from placental tissue; wound dressings; wound dressings derived from placental tissue; wound coverings made from human placental tissue, namely, coverings for damaged integumental tissue; wound coverings derived from human placental membrane tissue, namely, coverings for damaged integumental tissue
A cutting device is provided having multiple evenly-spaced cutting blades and which is useful for producing tissue forms comprising membranous tissue fragments which are relatively uniformly sized and shaped. The present invention also relates to methods for using the cutter device to quickly and efficiently produce such tissue forms which are useful as grafts and can be flowable and easily passable through a luer-slip tip syringe or needle.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Allograft material, namely, processed human bone and tissue
for use in surgical or medical procedures; allograft
material, namely, human bone and tissue processed into
implants, scaffolds, powders, gels, pastes, putty, mats,
films, strips, sheets, molded pieces, surgical patches,
plugs, wound dressings, or wound coverings; growth factors,
namely, proteins for promoting tissue growth and repair,
processed into surgical implants, scaffolds and plugs for
the repair and replacement of human bone and tissue defects;
processed acellular human dermis and fascia tissue intended
for subsequent implantation or for use in cosmetic surgery;
human allograft tissue derived from dermis; human allograft
tissue for topical use comprised of tissue from placental
membranes; human allograft tissue derived from placental
tissue; human allograft tissue derived from adipose matrix;
adipose cavity filler; soft tissue implant for use in
surgery; bone void fillers consisting of biological
materials; bone void fillers consisting of natural
materials; cartilage implants derived from living tissue;
hydrated packaging containers specially designed for
transporting and holding allograft implants made from living
tissue and bone. Allograft transplantation instruments, namely, forceps,
lesion reamers, depth gauges, lesion gauges, surgical saws,
namely, core saws, drivers, graft retrievers, dilators,
tamps, guide bushings, guide pins, graft stations, alignment
guides, mallets, wrenches, and chamfer tools; allograft
fixation devices, namely, pins; autologous systems, namely,
biological material transfer devices, namely, blood transfer
devices for medical purposes having at least one cannula and
kits comprised of a transfer device, container with a
coagulation activator and a container with or without an
anti-coagulant; hydrated packaging containers specially
designed for transporting and holding allograft implants
made from synthetic materials; surgical vise with moveable
cutter clamp. Human allograft tissue processing services, namely,
preparing biological tissue for subsequent implantation in
the human body. Providing on-line non-downloadable computer software used to
obtain organ and tissue procurement and to track organ and
tissue donations and maintain a database of hospitals
participating in organ and tissue donation programs, the
foregoing software for use in the field of organ procurement
and tissue banking; providing temporary use of on-line
non-downloadable computer software that functions as a
screening database for organ and tissue donor referrals in
the field of organ procurement and tissue banking, such
software not used to monitor patient placement, turnover or
procedure status. Human allograft tissue bank donor services; medical services
in the field of human tissue, cells, bone and organ
donations, namely, obtaining donor consent and human donor
referrals, conducting donor screening surveys, collecting
donor medical data, coordinating donor recoveries with
outside entities, and providing statistical donor data to
others.
50.
Cartilage-derived implants and methods of making and using same
Cartilage fibers and implants made therefrom are disclosed, with and without cartilage particles. Methods for making the cartilage fibers and the implants containing them are also disclosed. The implants may be pre-shaped, may be reshapable and, when implanted in a cartilage defect, the implants have good shape retention, little swelling, completely fill the cartilage defect and resist migration from the defect upon irrigation.
Arranging for pickup, delivery, storage and transportation of documents in the nature of letters and notes between tissue recipients and tissue donor families for the purpose of honoring the donation gift via ground and air carriers
Multiple component grafts are provided for treatment of tissue defects and comprise two or more components, each of which is a tissue-derived matrix and at least two of which are derived from different types of tissue. For example, a first component may be a matrix derived from cartilage tissue such as cartilage fibers with or without viable cells, cartilage particles with or without viable cells, or combinations of any two or more such cartilage-derived matrices. A second component may be a matrix derived from bone tissue such as mineralized or demineralized cortical bone fibers, viable cancellous bone matrix (e.g., cryopreserved or lyophilized chips, particulates, powder, sheets, putty, flowable fluid, etc.), demineralized or demineralized cancellous bone matrix (chips, particulates, powder, sheets, putty, flowable fluid, etc.), or combinations of any two or more of such bone-derived matrices. Also provided are methods for making and using such multiple component grafts.
Cartilage fibers and implants made therefrom are disclosed, with and without cartilage particles. Methods for making the cartilage fibers and the implants containing them are also disclosed. The implants may be pre-shaped, may be reshapable and, when implanted in a cartilage defect, the implants have good shape retention, little swelling, completely fill the cartilage defect and resist migration from the defect upon irrigation.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Human allograft tissue; human allograft tissue derived from
dermis; wound dressings; wound dressings derived from
dermis; wound coverings made from dermis, namely, wound care
scaffolds for the replacement of damaged or inadequate
integumental tissue, namely, diabetic foot ulcers, venous
leg ulcers, and pressure ulcers, and for other homologous
use.
Preserved tissue samples contain endogenous viable cells and retain or promote biological activity after being stored at temperatures above freezing for extended periods of time (e.g., from 14 days to 3 years). The preserved tissue samples are implanted in or on a subject and, after rehydration, they retain beneficial biological activity, promote beneficial biological activity, or both. The beneficial biological activity comprises promoting one or more of tissue healing, tissue growth, and tissue generation. Methods for preparing the preserved tissue samples include contacting a recovered tissue sample with one or more protectants, followed by lyopreservation. Suitable protectants include sugars, polyphenols, carotenoids, and combinations thereof. Preferred protectants include glucose, fructose, sucrose, trehalose, dextran, EGCG, and combinations thereof. The recovered tissue sample may be any of several possible issue types. In preferred embodiments, the recovered tissue samples are selected from bone, placental, cartilage and combinations thereof.
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 comprising simulated hypoxia to produce a primed tissue, wherein when grafted to a recipient the primed tissue provides a benefit compared to non-primed tissue.
Provided herein are compositions containing dehydrated placental tissue particulates, methods of making the compositions and methods for treating various musculoskeletal disorders and other conditions using such compositions, including osteoarthritis (OA), degenerative disc disease, tendonitis, plantar fasciitis, and pain associated therewith.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Allograft material, namely, processed human bone and tissue for use in surgical or medical procedures; allograft material, namely, human bone and tissue processed into implants, scaffolds, powders, gels, pastes, putty, mats, films, strips, sheets, molded pieces, surgical patches, plugs, wound dressings, or wound coverings; growth factors, namely, proteins for promoting tissue growth and repair, processed into surgical implants, scaffolds and plugs for the repair and replacement of human bone and tissue defects; processed acellular human dermis and fascia tissue intended for subsequent implantation or for use in cosmetic surgery; human allograft tissue derived from dermis; human allograft tissue for topical use comprised of tissue from placental membranes; human allograft tissue derived from placental tissue; human allograft tissue derived from adipose matrix; adipose cavity filler; soft tissue implant for use in surgery; bone void fillers consisting of biological materials; bone void fillers consisting of natural materials; cartilage implants derived from living tissue; hydrated packaging containers specially designed for transporting and holding allograft implants made from living tissue and bone.
(2) Allograft transplantation instruments, namely, forceps, lesion reamers, depth gauges, lesion gauges, surgical saws, namely, core saws, drivers, graft retrievers, dilators, tamps, guide bushings, guide pins, graft stations, alignment guides, mallets, wrenches, and chamfer tools; allograft fixation devices, namely, pins; autologous systems, namely, biological material transfer devices, namely, blood transfer devices for medical purposes having at least one cannula and kits comprised of a transfer device, container with a coagulation activator and a container with or without an anti-coagulant; hydrated packaging containers specially designed for transporting and holding allograft implants made from synthetic materials; surgical vise with moveable cutter clamp. (1) Human allograft tissue processing services, namely, preparing biological tissue for subsequent implantation in the human body.
(2) Providing on-line non-downloadable computer software used to obtain organ and tissue procurement and to track organ and tissue donations and maintain a database of hospitals participating in organ and tissue donation programs, the foregoing software for use in the field of organ procurement and tissue banking; providing temporary use of on-line non-downloadable computer software that functions as a screening database for organ and tissue donor referrals in the field of organ procurement and tissue banking, such software not used to monitor patient placement, turnover or procedure status.
(3) Human allograft tissue bank donor services; medical services in the field of human tissue, cells, bone and organ donations, namely, obtaining donor consent and human donor referrals, conducting donor screening surveys, collecting donor medical data, coordinating donor recoveries with outside entities, and providing statistical donor data to others.
67.
Acellular soft tissue-derived matrices and methods for preparing same
Compositions including a first soft tissue-derived matrix and a second soft tissue-derived matrix are provided, as well as methods of making such compositions. In some embodiments, the composition comprises dilapidated, decellularized adipose tissue-derived matrix and dilapidated, decellularized fascial tissue-derived matrix, which may be combined in various proportions. Such adipose-fascia matrix compositions provide improved volume retention when implanted into a patient. The composition may further include exogenous cells or other substances, and/or a carrier. The composition is suitable for use in plastic surgery procedures, including reconstructive or cosmetic surgery procedures, as well as procedures for wound treatment and tissue regeneration. The methods for making the compositions may involve separation of first and second soft tissues from one another, followed by performing one or more treatments on the separated soft tissues, then combining the treated soft tissues and, optionally, performing one or more additional treatments on the combined soft tissues.
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.
Allografts for soft tissue repair, including breast reconstruction and other plastic surgery procedures, are disclosed. One allograft is made from decellularized dermal tissue and constitutes a collagen matrix having substantially uniform density and porosity. Another allograft is a hybrid bilayer tissue form that is made from decellularized dermal and adipose tissues. Methods for making both allografts are also disclosed.
Soft tissue repair grafts are provided for supporting, covering, and/or retaining an implant positioned in the body of a subject. The grafts are particularly suitable for use for pre-pectoral breast reconstruction with a breast implant or tissue expander. The grafts include positional notches for more accurate positioning in a subject. The grafts also include at least one cuff element which is folded to form a reinforced folded edge for suturing the graft more securely to adjacent tissues than previously known grafts. The grafts also include a plurality of arcuate slots which form a plurality of circular patterns arranged concentrically about a focal point, thereby enabling the grafts to expand without tearing and to conform more closely to the implant and/or adjacent body tissues such as the breast pocket, than previously known grafts. Acellular dermal matrices are particularly suitable for making the soft tissue repair grafts.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
The present invention relates generally to tissue forms useful as grafts or implants and derived from membranous tissue. The tissue forms may contain viable endogenous cells. The tissue forms may be sheets or mini sheets, each having quadrilateral, circular, polygonal, or irregular shapes. The sheet tissue form may have a generally quadrilateral shape, with an average length of about 1 to about 20 centimeters and an average width of about 1 to about 20 centimeters. The mini sheet tissue form may have a generally quadrilateral shape, with an average length of about 0.5 to about 9 millimeters and an average width of about 0.5 to about 9 millimeters. A mixture of the mini sheet tissue form and a liquid, such as cryopreservation fluid, saline or buffer solution, is flowable, which means the mixture will pass through a luer-slip tip syringe, or a gauge needle.
Tissue derived porous matrices for treating wounds are provided, as well as methods for making and using them. The tissue derived porous matrices comprise processed tissue of any of several types, such as placenta, dermis, etc., and have a plurality of interconnected pores which allow fluid flow through the matrices. The tissue derived matrices are biocompatible resorbable matrices which remodel with native tissue and facilitate and enhance cell infiltration and tissue ingrowth into the matrices during the wound healing process, thereby enhancing wound healing and tissue remodeling when implanted into a patient. The tissue derived matrices are useful with negative pressure wound healing methods and systems, without the need to repeatedly revisit the treatment site and remove previously implanted matrices.
A61L 15/40 - Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof
A61L 15/42 - Use of materials characterised by their function or physical properties
A tissue graft container is provided having an interior space and including a vent which allows fluid (liquid and vapor) to escape from the container during drying of the tissue graft. The vent may be one or more apertures, one or more elongated openings, or a combination thereof, through one or more components of the container. A tissue graft packaging system having a retainer including first and second members with respective first and second pluralities of channels, and configured to removeably interconnect the first and second members in a closed configuration. The first and second pluralities of channels create a continuous interior space. The retainer further includes a vent, such as apertures, slits, etc., through one or both of the first and second retainers, for allowing moisture to escape from the retainer during the drying of a tissue graft contained within the continuous interior space of the retainer.
Decellularized muscle matrices are provided for use as implants and grafts to repair, regenerate, supplement, reinforce and replace muscle tissue. The decellularized muscle matrices are derived from muscle tissue having preserved extracellular matrix components, retained muscle-forming potential, and from which immunogenic components have been removed. The decellularized muscle matrices are produced in various physical forms and combinations. Methods for making and using the decellularized muscle matrices are also provided.
A medical implant packaging assembly having an outer tray, an inner tray and a retainer. An implant which may include a hydrated tissue graft may be positioned within the packaging assembly. The inner tray is formed from a moisture barrier material whereby the implant may be maintained in a hydrated state, even if the implant is not immersed in fluid within the packaging assembly, thereby avoiding need for rehydrating steps that are required for dehydrated and/or cryopreserved implants prior to or during surgery. The outer tray and inner tray and a retainer are also made of transparent materials, enabling medical personnel to view the implant through these packaging components prior to and during surgery.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
B65D 75/32 - Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
A61L 27/36 - Materials for prostheses or for coating prostheses containing ingredients of undetermined constitution or reaction products thereof
A61L 27/54 - Biologically active materials, e.g. therapeutic substances
79.
Acellular soft tissue-derived matrices and methods for preparing same
An acellular soft tissue-derived matrix suitable for use as a medical graft or implant may comprise, for example, a delipidated, decellularized adipose tissue matrix. The delipidated, decellularized adipose tissue matrix is substantially free of substances that pose a significant risk of causing an immunogenic response in a patient receiving the matrix. Methods for producing the delipidated, decellularized adipose tissue matrix include the steps of delipidating an adipose tissue sample, followed by decellularizing the delipidated adipose tissue sample. The resulting delipidated, decellularized adipose tissue matrix contains a proportion of Type IV collagen which is greater than the proportion of Type IV collagen contained in a matrix produced by decellularizing an adipose tissue sample prior to delipidating. Additionally, the delipidated, decellularized adipose tissue matrix contains a proportion of lipids which is less than the proportion of lipids contained in a matrix produced by decellularizing an adipose tissue sample prior to delipidating.
Soft tissue repair grafts are provided for supporting, covering, and/or retaining an implant positioned in the body of a subject. The grafts are particularly suitable for use for pre-pectoral breast reconstruction with a breast implant or tissue expander. The grafts include positional notches for more accurate positioning in a subject. The grafts also include at least one cuff element which is folded to form a reinforced folded edge for suturing the graft more securely to adjacent tissues than previously known grafts. The grafts also include a plurality of arcuate slots which form a plurality of circular patterns arranged concentrically about a focal point, thereby enabling the grafts to expand without tearing and to conform more closely to the implant and/or adjacent body tissues such as the breast pocket, than previously known grafts. Acellular dermal matrices are particularly suitable for making the soft tissue repair grafts.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Methods for making surgical implants (or grafts) for the repair of bone defects, and more particularly, surgical implants that include demineralized bone fibers, are disclosed. Also disclosed are methods for increasing the wettability and ensuring uniform density of such implants. The surgical implants have a wettability time of less than 5 minutes and a residual moisture content of less than 6% by weight, and they remain cohesive and retain their shape upon complete rehydration.
40 - Treatment of materials; recycling, air and water treatment,
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Human allograft tissue processing services, namely, preparing biological tissue for subsequent implantation in the human body Human allograft tissue bank donor services; Maintaining files and records concerning the donation of human tissue between and among the hospital, donor and recipient; Medical services in the field of human tissue, cells, bone and organ donations, namely, obtaining donor consent and human donor referrals, conducting donor screening surveys, collecting donor medical data, coordinating donor recoveries with outside entities, and providing statistical donor data to others
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Human allograft tissue; human allograft tissue comprised of adipose matrix; human allograft tissue derived from adipose matrix; human allograft tissue in the nature of adipose cavity filler
Compositions including a first soft tissue-derived matrix and a second soft tissue-derived matrix are provided, as well as methods of making such compositions. In some embodiments, the composition comprises delipidated, decellularized adipose tissue-derived matrix and delipidated, decellularized fascial tissue-derived matrix, which may be combined in various proportions. Such adipose-fascia matrix compositions provide improved volume retention when implanted into a patient. The composition may further include exogenous cells or other substances, and/or a carrier. The composition is suitable for use inplastic surgery procedures, including reconstructive or cosmetic surgery procedures, as well as procedures for wound treatment and tissue regeneration. The methods for making the compositions may involve separation of first and second soft tissues from one another, followed by performing one or more treatments on the separated soft tissues, then combining the treated soft tissues and, optionally, performing one or more additional treatments on the combined soft tissues.
A medical implant packaging assembly having an outer tray, an inner tray and a retainer The implant may include a tissue graft. The inner tray is formed from a moisture barrier material whereby the implant may be maintained in a hydrated state, thereby avoiding need for rehydrating steps that are required for dehydrated or cryopreserved implants. The outer tray and inner tray and a retainer are also made of transparent materials, enabling medical personnel to view the implant through these packaging components prior to and during surgery.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
B65D 75/32 - Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
A61L 27/36 - Materials for prostheses or for coating prostheses containing ingredients of undetermined constitution or reaction products thereof
A61L 27/54 - Biologically active materials, e.g. therapeutic substances
Promoting public awareness of the need for neonatal organ and tissue donors through a website featuring testimonials and named stars that honor those who have donated organs and tissues for research and medical education
90.
Soft tissue repair allografts and methods for preparing same
Allografts for soft tissue repair, including breast reconstruction and other plastic surgery procedures, are disclosed. One allograft is made from decellularized dermal tissue and constitutes a collagen matrix having substantially uniform density and porosity. Another allograft is a hybrid bilayer tissue form that is made from decellularized dermal and adipose tissues. Methods for making both allografts are also disclosed.
The disclosure provides implants containing a plurality of particles containing at least one population of viable cells adherent to and resident in soft tissue matrix or at least one viable population of cells caused to be in contact with the soft tissue matrix; methods of fabricating the implants; and use of the implants in tissue repair.
40 - Treatment of materials; recycling, air and water treatment,
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Human allograft tissue processing services, namely, preparing biological tissue for subsequent implantation in the human body Human allograft tissue bank donor services; Maintaining files and records concerning the donation of human tissue between and among the hospital, donor and recipient; Medical services in the field of human tissue, cells, bone and organ donations, namely, obtaining donor consent and human donor referrals, conducting donor screening surveys, collecting donor medical data, coordinating donor recoveries with outside entities, and providing statistical donor data to others
An acellular soft tissue-derived matrix includes a collagenous tissue that has been delipidated and decellularized. Adipose tissue is among the soft tissues suitable for manufacturing an acellular soft tissue-derived matrix. Exogenous tissuegenic cells and other biologically-active factors may be added to the acellular matrix. The acellular matrix may be provided as particles, a slurry, a paste, a gel, or in some other form. The acellular matrix may be provided as a three-dimensional scaffold that has been reconstituted from particles of the three-dimensional tissue. The three-dimensional scaffold may have the shape of an anatomical feature and serve as a template for tissue repair or replacement. A method of making an acellular soft tissue-derived matrix includes steps of removing lipid from the soft tissue by solvent extraction and chemical decellularization of the soft tissue.
The disclosure provides implants containing a plurality of particles containing at least one population of viable osteogenic cells adherent to and resident in an osteoconductive matrix or at least one viable population of osteogenic cells caused to be in contact with the osteoconductive matrix; methods of fabricating the implants; and use of the implants in bone repair. The implant further contains an osteoinductive component. An example of an osteoinductive component is a demineralized bone matrix in the form of particles or fibers.
A tissue graft packaging system having a retainer including first and second members with respective first and second pluralities of channel sidewalls that define first and second pluralities of channels, and first and second engagement means configured to removeably interconnect the first and second members. The first and second pluralities of channel sidewalls are configured to create a continuous interior space between the first and second members. A tissue graft, such as a cryopreserved viable tissue graft, is contained within the continuous interior space of the retainer. Processes for packaging, thawing and rinsing the tissue graft using the tissue graft packaging system and its retainer are also disclosed.
A61F 2/00 - Filters implantable into blood vesselsProstheses, i.e. artificial substitutes or replacements for parts of the bodyAppliances for connecting them with the bodyDevices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
B65B 25/00 - Packaging other articles presenting special problems
B65B 9/04 - Enclosing successive articles, or quantities of material, between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material
