Abstract: A device for introduction and delivery of a self-adhesive surgical patch during minimally invasive surgery is disclosed. The device comprises a base that can be compressed to fit inside a 5 mm i.d. tubular member. In preferred embodiments of the invention, the base comprises a frame made of a compliant material. The patch is attached to the frame while the frame is in a planar open configuration. Pressure is then applied to opposite sides of the frame, compressing it to a linear closed configuration small enough to pass through a 5 mm i.d. tubular member. After passing through the tubular member, the frame is reopened to its open configuration, enabling delivery and attachment of the patch to a target tissue. A kit for providing the device is also disclosed.

Abstract: A method of production of a tissue sealing patch is disclosed. The method comprises applying a vacuum to a heated work surface; applying a solution of a biocompatible polyurethane polymer to the work surface and spreading it over the work surface with a polymer blade; evaporating the solvent; heating the work surface above the softening temperature of the polymer; spreading powdered tissue sealant material over the polymer film; incorporating the tissue sealant material to a depth of 20-60 ?m in the film by pressing on a release sheet placed over the powder and polymer film; removing the release sheet from the adhesive patch material; releasing the vacuum; cooling said work surface; and removing the adhesive patch material from said work surface. The biocompatible polymer preferably comprises PEG-caprolactone-lactic acid units connected by urethane linkages, the PEG having a molecular weight of 3000-3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Abstract: A method for measuring the adhesive strength of a hemostatic tissue patch. Two patches are attached to facing surfaces with a side that would normally seal tissue exposed. Liquid is placed on one of the patches to activate the hemostatic agent, the patches held together long enough to adhere to one another, and then pulled apart. The force necessary to detach them is measured, thereby providing a determination of the adhesive strength of the patch. In contrast to literature methods, the inventive method provides excellent reproducibility.

Abstract: A method of production of a tissue sealing patch is disclosed. The method comprises casting a polymer film from a biocompatible polyethylene glycol-caprolactone-lactide triblock copolymer (PECALA); softening the polymer film; placing a powdered tissue sealant material on a surface of said polymer film; and, pressing said polymer film to at least partially incorporate the sealant material into said surface of said polymer film. In some embodiments of the invention, the polymer film is created by heating and evacuating a work surface; applying a solution of PECALA to said work surface; adjusting a polymer blade to a predetermined height above said work surface; spreading said solution of PECALA over said work surface with said polymer blade; and evaporating said solvent. The PECALA preferably comprises PEG-CL-LA units connected by urethane linkages, PEG having a molecular weight of between 3000 and 3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Abstract: A method of production of a tissue sealing patch is disclosed. The method comprises applying a vacuum to a heated work surface; applying a solution of a biocompatible polyurethane polymer to the work surface and spreading it over the work surface with a polymer blade; evaporating the solvent; heating the work surface above the softening temperature of the polymer; spreading powdered tissue sealant material over the polymer film; incorporating the tissue sealant material to a depth of 20-60 ?m in the film by pressing on a release sheet placed over the powder and polymer film; removing the release sheet from the adhesive patch material; releasing the vacuum; cooling said work surface; and removing the adhesive patch material from said work surface. The biocompatible polymer preferably comprises PEG-caprolactone-lactic acid units connected by urethane linkages, the PEG having a molecular weight of 3000-3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Abstract: A method for measuring the adhesive strength of a hemostatic tissue patch. Two patches are attached to facing surfaces with a side that would normally seal tissue exposed. Liquid is placed on one of the patches to activate the hemostatic agent, the patches held together long enough to adhere to one another, and then pulled apart. The force necessary to detach them is measured, thereby providing a determination of the adhesive strength of the patch. In contrast to literature methods, the inventive method provides excellent reproducibility.

Abstract: A novel fibrinogen-based tissue adhesive patch is disclosed. The patch comprises a backing made from a non-permeable biocompatible polymer film into which a fibrinogen-based sealant is incorporated. In preferred embodiments of the invention, the biocompatible polymer film comprises units of a biocompatible block copolymer such as a polyethylene glycol-polycaprolactone-DL-lactide copolymer connected by urethane linkages, and the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl2. In contrast to similar patches known in the art, the polymer backing serves to seal the tissue to which the patch is applied, and the sealant acts only to bind the patch to the affected tissue. The patch does not include any mesh, woven, or non-woven component. Methods of production and use of the patch are also disclosed.

Abstract: A method of production of a tissue sealing patch is disclosed. The method comprises casting a polymer film from a biocompatible polyethylene glycol-caprolactone-lactide triblock copolymer (PECALA); softening the polymer film; placing a powdered tissue sealant material on a surface of said polymer film; and, pressing said polymer film to at least partially incorporate the sealant material into said surface of said polymer film. In some embodiments of the invention, the polymer film is created by heating and evacuating a work surface; applying a solution of PECALA to said work surface; adjusting a polymer blade to a predetermined height above said work surface; spreading said solution of PECALA over said work surface with said polymer blade; and evaporating said solvent. The PECALA preferably comprises PEG-CL-LA units connected by urethane linkages, PEG having a molecular weight of between 3000 and 3500 amu, and a CL:LA:PEG ratio of 34:2:1.

Abstract: An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film in which the PEG-CL-LA units are preferably connected by urethane linkages and into a surface of which a fibrinogen-based sealant comprising less than 8 mg/cm2 fibrinogen and less than 10 IU/cm2 thrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.

Abstract: An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film in which the PEG-CL-LA units are preferably connected by urethane linkages and into a surface of which a fibrinogen-based sealant comprising less than 8 mg/cm2 fibrinogen and less than 10 IU/cm2 thrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.

Abstract: A novel fibrinogen-based tissue adhesive patch is disclosed. The patch comprises a backing made from a non-permeable biocompatible polymer film into which a fibrinogen-based sealant is incorporated. In preferred embodiments of the invention, the biocompatible polymer film comprises units of a biocompatible block copolymer such as a polyethylene glycol-polycaprolactone-DL-lactide copolymer connected by urethane linkages, and the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl2. In contrast to similar patches known in the art, the polymer backing serves to seal the tissue to which the patch is applied, and the sealant acts only to bind the patch to the affected tissue. The patch does not include any mesh, woven, or non-woven component. Methods of production and use of the patch are also disclosed.

Abstract: An improved fibrinogen-based tissue sealing patch having a degradation time of less than two weeks is disclosed. The patch comprises a polyethylene glycol-caprolactone-lactide (PEG-CL-LA) triblock copolymer film into which a fibrinogen-based sealant comprising less than 8 mg/cm2 fibrinogen and less than 10 IU/cm2 thrombin has been incorporated. In preferred embodiments, the polymer film comprises PEG having a molecular weight of between 3000 and 3500 and a CL:LA:PEG ratio of 34:2:1. Methods of production and use of the patch are also disclosed.

Abstract: The present application relates to an immunoglobulin preparation comprising anti-hepatitis B antibodies for subcutaneous administration and to uses thereof, including methods for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus.

Abstract: A concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, is made by (a) selecting a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism; (b) identifying very high titer individuals by determining the level of specific antibodies immunoreactive with the pathogenic microorganism in the blood of the individuals; (c) combining blood from the very high titer individuals; and (d) purifying and/or concentrating the product of step (c). A concentrated immunoglobulin composition can include specific antibodies immunoreactive with a pathogenic microorganism, wherein the titer of specific antibodies is at least 5 times higher than the average titer of specific antibodies of a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism. The composition has a relatively high protein concentration and a low percentage of protein aggregates.

Abstract: A novel fibrinogen-based tissue adhesive patch is disclosed. The patch comprises a backing made from a non-permeable biocompatible polymer film into which a fibrinogen-based sealant is incorporated. In preferred embodiments of the invention, the fibrinogen-based sealant comprises fibrinogen, thrombin, and CaCl2. The polymer backing serves to seal the tissue to which the patch is applied, and the sealant acts only to bind the patch to the affected tissue. The patch does not include any mesh or woven component. Methods of production of the patch are also disclosed.

Abstract: The present application relates to an immunoglobulin preparation comprising anti-hepatitis B antibodies for subcutaneous administration and to uses thereof, including methods for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus

Abstract: The present application relates to an immunoglobulin preparation comprising anti-hepatitis B antibodies for subcutaneous administration and to uses thereof, including methods for treating, preventing and/or reducing a disease, disorder or condition associated with hepatitis B virus.

Abstract: Methods for preparation of molecularly imprinted polymers and their use for detection of proteins and/or polypeptides in a sample are disclosed. The methods of preparation are based on selecting from available data bases an amino acid sequence of a protein/polypeptide target molecule; cleaving the sequence in-silico with at least one cleaving agent, producing fragments with known composition; selecting at least one such fragment comprising a unique epitope; preparing a synthetic peptide representing the unique epitope; and preparing a molecularly imprinted polymer comprising specific binding sites for the synthetic peptide. For detection of the target protein in a sample, the same cleaving agent used for the in-silico cleavage is used to cleave the target protein to form the specific peptide fragments to which the MIP is specific.

Abstract: A method for preparing a concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, comprising: (a) selecting a population of individuals previously vaccinated against one or more antigens associated with the pathogenic microorganism; (b) determining the level of specific antibodies immunoreactive with the pathogenic microorganism in a blood or blood component of the individuals to identify very high titre individuals having a very high titre of the specific antibodies; (c) combining blood or blood components comprising immunoglobulins from the very high titre individuals; and (d) purifying and/or concentrating the product of step (c), thereby obtaining a concentrated immunoglobulin composition.

Abstract: A concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, is made by (a) selecting a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism; (b) identifying very high titre individuals by determining the level of specific antibodies immunoreactive with the pathogenic microorganism in the blood of the individuals; (c) combining blood from the very high titre individuals; and (d) purifying and/or concentrating the product of step (c). A concentrated immunoglobulin composition can include specific antibodies immunoreactive with a pathogenic microorganism, wherein the titre of specific antibodies is at least 5 times higher than the average titre of specific antibodies of a population of individuals previously vaccinated against antigens associated with the pathogenic microorganism. The composition has a relatively high protein concentration and a low percentage of protein aggregates.