Abstract: A system and method for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, a membrane configured to transmit air or solvent vapor out of the flexible container, and a membrane frame supporting the membrane and engaged with at least one column member. The at least one column member can be configured to maintain the membrane and the membrane frame a spaced distance from one or more contents received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration. A method can include inserting a biological material, for example, into a flexible container, freeze-drying the biological material, moving the freeze-dried biological material to a portion of the flexible container that includes at least one port, and sealing the biological material within the portion.

Abstract: Embolic materials, suspensions, kits and related methods useful for embolization are disclosed. An embolic material can comprise a resorbable microsphere including cross-linked gelatin as its primary ingredient and having a substantially spherical shape with a diameter of about 50 micrometers to about 1,500 micrometers, inclusive. The microsphere can optionally include one or both of a marker or an active agent. The microsphere can be cross-linked, such as with glutaraldehyde or formaldehyde, which can affect the microsphere's in vivo degradation profile and ability to withstand a sterilization process at certain temperatures. In an embodiment, the microspheres can resorb during an in vivo time period of between about 24 hours and about 15 weeks, inclusive. An embolization suspension can include a plurality of resorbable microspheres and a liquid carrier, and the suspension can be disposed in a syringe, vial or other applicator for administration to a patient.

Abstract: A system and method for freeze-drying a heat-sensitive substance. In some embodiments, the system and method include freeze-drying the heat-sensitive substance in an upright container with a membrane for transmitting air or vapor solvent out of the container.

Abstract: A system and method for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, a membrane configured to transmit air or solvent vapor out of the flexible container, and a membrane frame supporting the membrane and engaged with at least one column member. The at least one column member can be configured to maintain the membrane and the membrane frame a spaced distance from one or more contents received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration. A method can include inserting a biological material, for example, into a flexible container, freeze-drying the biological material, moving the freeze-dried biological material to a portion of the flexible container that includes at least one port, and sealing the biological material within the portion.

Abstract: Systems and methods for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, at least two membranes configured to transmit air or solvent vapor out of the flexible container, and a port to allow for the introduction or withdrawal of a material or substance into or out of the flexible container. The system can optionally further comprise a membrane frame supporting at least one of the membranes and engaged with at least one column member. The at least one column member can be configured to maintain the membranes and the membrane frame a spaced distance from one or more materials received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration.

Abstract: A system and method for freeze-drying a heat-sensitive substance. In some embodiments, the system and method include freeze-drying the heat-sensitive substance in an upright container with a membrane for transmitting air or vapor solvent out of the container.

Abstract: Embolic materials, suspensions, kits and related methods useful for embolization are disclosed. An embolic material can comprise a resorbable microsphere including cross-linked gelatin as its primary ingredient and having a substantially spherical shape with a diameter of about 50 micrometers to about 1,500 micrometers, inclusive. The microsphere can optionally include one or both of a marker or an active agent. The microsphere can be cross-linked, such as with glutaraldehyde or formaldehyde, which can affect the microsphere's in vivo degradation profile and ability to withstand a sterilization process at certain temperatures. In an embodiment, the microspheres can resorb during an in vivo time period of between about 24 hours and about 15 weeks, inclusive. An embolization suspension can include a plurality of resorbable microspheres and a liquid carrier, and the suspension can be disposed in a syringe, vial or other applicator for administration to a patient.

Abstract: Embolic materials, suspensions, kits and related methods useful for embolization are disclosed. An embolic material can comprise a resorbable microsphere including cross-linked gelatin as its primary ingredient and having a substantially spherical shape with a diameter of about 50 micrometers to about 1,500 micrometers, inclusive. The microsphere can optionally include one or both of a marker or an active agent. The microsphere can be cross-linked, such as with glutaraldehyde or formaldehyde, which can affect the microsphere's in vivo degradation profile and ability to withstand a sterilization process at certain temperatures. In an embodiment, the microspheres can resorb during an in vivo time period of between about 24 hours and about 15 weeks, inclusive. An embolization suspension can include a plurality of resorbable microspheres and a liquid carrier, and the suspension can be disposed in a syringe, vial or other applicator for administration to a patient.

Abstract: Assemblies and methods for delivering an implant to a patient are disclosed. A delivery assembly can comprise an elongate tube, an outer magnetic member, and an inner magnetic member. The elongate tube extends from a proximal end portion to a distal end portion and defines a delivery lumen. The outer magnetic member can be movable along an outer surface of the tube; the inner magnetic member can be positioned within the delivery lumen and magnetically coupled to the outer magnetic member through a sidewall of the tube. The inner magnetic member can be movable through the delivery lumen when actuated by relative movement between the outer magnetic member and the tube. The delivery assembly can further comprise a syringe or an inflator/deflator couplable to a hub at the proximal end portion of the tube. The syringe or inflator/deflator can be used to urge fluid against a proximal end portion of the inner magnetic member.

Abstract: Systems and methods for protecting biological or other material from contamination through the steps of filling, freeze-drying, packaging, storing and use are disclosed. A system can include a flexible container, at least two membranes configured to transmit air or solvent vapor out of the flexible container, and a port to allow for the introduction or withdrawal of a material or substance into or out of the flexible container. The system can optionally further comprise a membrane frame supporting at least one of the membranes and engaged with at least one column member. The at least one column member can be configured to maintain the membranes and the membrane frame a spaced distance from one or more materials received within the flexible container. Upon application of a downward force, the at least one column member can assume a collapsed configuration.

Abstract: Assemblies and methods for delivering an implant to a patient are disclosed. A delivery assembly can comprise an elongate tube, an outer magnetic member, and an inner magnetic member. The elongate tube extends from a proximal end portion to a distal end portion and defines a delivery lumen. The outer magnetic member can be movable along an outer surface of the tube; the inner magnetic member can be positioned within the delivery lumen and magnetically coupled to the outer magnetic member through a sidewall of the tube. The inner magnetic member can be movable through the delivery lumen when actuated by relative movement between the outer magnetic member and the tube. The delivery assembly can further comprise a syringe or an inflator/deflator couplable to a hub at the proximal end portion of the tube. The syringe or inflator/deflator can be used to urge fluid against a proximal end portion of the inner magnetic member.

Abstract: Assemblies, kits, and methods for occluding a vascular vessel, such as a varicose vein, are disclosed. An assembly can include a removable inner member, a removable outer member, and an elongated expandable member positioned in a compressed form between portions of the inner and outer members. To facilitate their removal, one or both of the inner and outer members can include a handle coupled to a proximal end. The elongated expandable member can include a gelatin material or a collagen material that is configured, when wetted, to expand from a compressed first diametrical size to a second larger diametrical size within a time period of 5 minutes or less. At the second larger diametrical size, the gelatin or collagen material can occlude a vascular vessel for a period of at least 20 days without degrading.

Abstract: Assemblies, kits, and methods for occluding a vascular vessel, such as a varicose vein, are disclosed. An assembly can include a removable inner member, a removable outer member, and an elongated expandable member positioned in a compressed form between portions of the inner and outer members. To facilitate their removal, one or both of the inner and outer members can include a handle coupled to a proximal end. The elongated expandable member can include a gelatin material or a collagen material that is configured, when wetted, to expand from a compressed first diametrical size to a second larger diametrical size within a time period of 5 minutes or less. At the second larger diametrical size, the gelatin or collagen material can occlude a vascular vessel for a period of at least 20 days without degrading.

Abstract: A hemostatic dressing for applying a hemostatic material such as lyophilized thrombin to a wound. The wound dressing includes an impermeable backing material and a sealing member to provide a seal against the skin. The wound dressing enables the application of pressure in order to seal the sealing member against the patient's skin to the wound without the need for attendance by a health care professional. The seal may be applied by a compressive band or by application of a pressure sensitive adhesive. The wound dressing creates a sealed localized procoagulation environment to facilitate the formation of a clot initiated by the presence of substantial quantities of externally supplied lyophilized thrombin or another dry coagulant.

Abstract: Approaches are described for separating plasma from whole blood samples and include the use of magnetically attractable particles associated with an agglutinating agent. The magnetically attractable particles bind the cellular components in a whole blood sample. Application of a magnetic field gradient to a container with the blood sample and the magnetically attractable particles draws the particles to the surface of the container near the source of the magnetic field gradient. The plasma can be removed and stored or used for monitoring or detecting analytes in the plasma.