Abstract: Dry cross-linked gelatin compositions are prepared that rapidly re-hydrate to produce gelatin hydrogels suitable as hemostatic sealants. Gelatin is cross-linked in the presence of certain re-hydration aids, such as polyethylene glycol, polyvinylprovidone, and dextran, in order to produce a dry cross-linked gelatin powder. The use of the re-hydration aids has been found to substantially increase the re-hydration rate in the presence of an aqueous re-hydration medium, typically thrombin-containing saline.

Abstract: Dry cross-linked gelatin compositions are prepared that rapidly re-hydrate to produce gelatin hydrogels suitable as hemostatic sealants. Gelatin is cross-linked in the presence of certain re-hydration aids, such as polyethylene glycol, polyvinylprovidone, and dextran, in order to produce a dry cross-linked gelatin powder. The use of the re-hydration aids has been found to substantially increase the re-hydration rate in the presence of an aqueous re-hydration medium, typically thrombin-containing saline.

Abstract: Dried hemoactive materials comprise both a cross-linked biologically compatible polymer and a non-cross-linked biologically compatible polymer. The cross-linked polymer is selected to form a hydrogel when exposed to blood. The non-cross-linked polymer is chosen to solubilize relatively rapidly when exposed to blood. The non-cross-linked polymer serves as a binder for holding the materials in desired geometries, such as sheets, pellets, plugs, or the like. Usually, the cross-linked polymer will be present in a particulate or fragmented form. The materials are particularly suitable for hemostasis and drug delivery.

Abstract: A percutaneous tissue track closure assembly (2) includes a semipermeable barrier (26) mounted to the distal end of a tubular barrier carrier (20). The barrier is passed down a tissue track (12) and into a blood vessel (18) where the barrier is expanded to close off the blood vessel opening (14). A syringe device is used to drive a hemostatic flowable material (30) through a delivery tube (34) and into the tissue track. The semipermeable barrier permits blood to flow therethrough but prevents passage of the hemostatic flowable material therethrough. The hemostatic material includes a material which swells upon contact with blood, and a blood clotting agent. After an appropriate period of time, the barrier is collapsed and the barrier carrier and delivery tube are removed from the tissue track.

Abstract: A percutaneous tissue track closure assembly (2) includes a semipermeable barrier (26) mounted to the distal end of a tubular barrier carrier (20). The barrier is passed down a tissue track (12) and into a blood vessel (18) where the barrier is expanded to close off the blood vessel opening (14). A syringe device is used to drive a hemostatic flowable material (30) through a delivery tube (34) and into the tissue track. The semipermeable barrier permits blood to flow therethrough but prevents passage of the hemostatic flowable material therethrough. The hemostatic material includes a material which swells upon contact with blood, and a blood clotting agent. After an appropriate period of time, the barrier is collapsed and the barrier carrier and delivery tube are removed from the tissue track.

Abstract: A percutaneous tissue track closure assembly (2) includes a semipermeable barrier(26) mounted to the distal end of a tubular barrier carrier (20). The barrier is passed down a tissue track (12) and into a blood vessel (18) where the barrier is expanded to close off the blood vessel opening (14). A syringe device is used to drive a hemostatic flowable material (30) through a delivery tube (34) and into the tissue track. The semipermeable barrier permits blood to flow therethrough but prevents passage of the hemostatic flowable material therethrough. The hemostatic material includes a material which swells upon contact with blood, and a blood clotting agent. After an appropriate period of time, the barrier is collapsed and the barrier carrier and delivery tube are removed from the tissue track.

Abstract: Cross-linked hydrogels comprise a variety of biologic and non-biologic polymers, such as proteins, polysaccharides, and synthetic polymers. Such hydrogels preferably have no free aqueous phase and may be applied to target sites in a patient's body by extruding the hydrogel through an orifice at the target site. Alternatively, the hydrogels may be mechanically disrupted and used in implantable articles, such as breast implants. When used in vivo, the compositions are useful for controlled release drug delivery, for inhibiting post-surgical spinal and other tissue adhesions, for filling tissue divots, tissue tracts, body cavities, surgical defects, and the like.

Abstract: Molecular cross-linked gels comprise a variety of biologic and non-biologic polymers, such as proteins, polysaccharides, and synthetic polymers. Such molecular gels may be applied to target sites in a patient's body by extruding the gel through an orifice at the target site. Alternatively, the gels may be mechanically disrupted and used in implantable articles, such as breast implants. When used in vivo, the compositions are useful for inhibiting post-surgical spinal and other tissue adhesions, for filling tissue divots, tissue tracts, body cavities, surgical defects, and the like.

Abstract: The present invention relates to a bioadhesive that includes at least two constituents that are intended to be combined, for simultaneous, separate, or time-shifted use, i.e.: 1) a semi-liquid constituent (A) that includes, at a minimum, gelatin in an aqueous solution; and 2) A constituent (B), in gel or non-gel form, that includes, at a minimum, an aldehyde, with the exception of non-gel solutions consisting of formaldehyde, glutaraldehyde, or glyceraldehyde. The invention also relates to the use of succinic dialdehyde and of aldehyde solution sin gel form as hardeners in a bioadhesive, and further relates to a procedure for the preparation of the said bioadhesives and to a device for the application of the said bioadhesives.

Abstract: A fluid dispersion and delivery assembly (16) includes first and second syringes (18,20) containing a first, fluid material (32) and a second material (34), fluidly coupled together at their distal ends (22,24) by a fluid transfer assembly (2). The fluid transfer assembly includes a double Luer fitting (4) and an elongated, hollow, perforated tube (6) extending into the interior (26) of the second syringe. This permits the first, fluid material in the first syringe to be properly dispersed into the second material within the second syringe by simply pressing the plunger (28) of the first syringe. The sizing, spacing and positioning of the holes (14) in the tube can be adjusted to provide even or uneven fluid distribution within the second syringe. After dispersion, the fluid transfer assembly is dismounted from the second syringe to permit combined material (36) within the second syringe to be dispensed.

Abstract: Gelatin film compositions are useful for immobilization over tissue, usually by the application of energy to the films. Exemplary films comprise cross-linked and non-cross-linked granular and non-granular gelatin sheets, typically including a plasticizer. The gelatin films are dry, thin, and preferably meet certain pliability, elasticity, melting temperature, and other criteria. Methods are described for producing these films from collagen. Methods are further described for applying these films to tissue.

Abstract: A fluid dispersion and delivery assembly (49) includes first and second syringes (28,50) containing a hemostatic solution (38) and a flowable gel material (58), fluidly coupled together by a fluid transfer assembly (2). The fluid transfer assembly includes a double Luer fitting (4) and a hollow tube (6), having openings (24,22) at its ends (16,18), reciprocally mounted within the fitting. This permits the hemostatic solution in the first syringe to be evenly dispersed into the flowable gel material within the second syringe by simply pressing the plunger (46) of the first syringe. After dispersion, the fluid transfer assembly is dismounted from the second syringe to permit combined material (62) within the second syringe to be dispensed.

Abstract: An apparatus and method for effecting and enhancing wound closure in tissue is disclosed. Wounds and tissue are sealed by heating a sealant material, such as collagen, in an applicator (10) to a temperature sufficient to melt the sealant. The melted sealant is then extruded through a distal tip of an elongate shaft (22) and applied to the target site, where it cools and sets to form bonds with the underlying tissue. The heated sealant flows over the wound to create an effective barrier against further blood leakage and, upon cooling, it readily adheres to the tissue to seal the wound. In addition, since high intensity energy is not applied directly to the wound, damage or destruction of neighboring tissue is minimized.

Abstract: A method for joining or reconstructing biological tissue comprises providing a solid filler material in the form of a preformed sheet, where the sheet comprises collagen, gelatin or a mixture thereof. The filler material is placed over tissue. Radiofrequency energy or optical energy is thereafter applied to the filler material in an amount sufficient to melt or denature the filler material.

Abstract: Tissue adhesions are inhibited by applying and immobilizing a solid preformed matrix material over a target region, such as a surgical site, in a first tissue surface. The matrix material may be any continuous solid material, such as a sheet or film. After applying the material to the target region, the material is immobilized by applying energy over at least a portion of the surface of the matrix material which causes the material to fuse to the underlying tissue. The matrix material is preferably bioabsorbable so that it is resorbed by the body over time. Suitable matrix materials include proteins, polysaccharrides, and synthetic polymers.

Abstract: Biological materials are joined, repaired or fused by heating the material in proximity to a mechanical support. Preferably, the mechanical support comprises a patch or bridge structure. In the most preferred embodiment, the patch is formed from collagen having a thickness from between 2 to 30 mils, and most preferably from 2 to 15 mils thick. Preferably, the patch or support structure contains holes or interlock vias which permit the coagulum to form a mechanical bond therewith, whether preformed or generated by an electrical energy source during welding. The preferred method comprises the steps of: first, placing the patch in contact with the materials to be joined, supplying energy to the tissue in an amount sufficient to form a coagulum at the surface of the patch, and finally, permitting the coagulum to form a mechanical bond with the support or patch.

Abstract: Wounds in lung tissue are closed in a two step method consisting essentially of applying fasteners to a region adjacent to the wound, wherein the fasteners may cause penetrations. The fasteners are present in a preformed layer of collagen, fibrin, fibrinogen, elastin, albumin, or a combination thereof, and energy is applied to the region to fuse the material to the tissue and seal perforations in the tissue.

Abstract: A method for joining or restructuring tissue consists essentially of providing a preformed film or sheet of a solid filler material which fuses to tissue upon the application of energy. The material comprises collagen, gelatin, mixtures thereof, optionally combined with a plasticizer, and the film may be cut prior to placing over the tissue. Radiofrequency energy is then applied at between about 20 and 120 Watts to the filler material and the tissue after the filler material has been placed over the tissue for about 1 to 60 seconds so that about 20 to 1800 joules are delivered to the filler material and tissue.