A packaging system is provided. The packaging system may include a packaging body defining a cavity. The packaging system may also include a tissue cradle configured to be disposed within the cavity. The packaging system may also include a seal configured to be joined to the packaging body to fluidly seal the cavity. Such packaging systems may be used in the storage of wet-preserved or dry-preserved human or animal tissue. Also provided are a packaged tissue specimen and a method for packaging tissue.

Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.

An implant-delivery sleeve may comprise an enclosure having at least one opening and at least one vent conduit. The vent conduit may extend along a surface of the enclosure to assist in removing fluids (e.g., blood and air) from the tissue pocket to facilitate implantation of the implant.

Techniques for mesh augmentation and prevention of incisional hernia, including systems and methods for affixing mesh to a fascial incision. A mesh strip can be integrated with one or more uni-directional fasteners. Each fastener can include an anchoring mechanism adapted for affixation to anterior abdominal wall fascia and a mating interface. An applicator can include tension arms adapted to interface with the mating interfaces of the fasteners to maintain a vertical tension of the mesh strip and a handle coupled with the tension arms adapted to spread the tension arms and thereby control a horizontal tension of the mesh strip. The mesh strip can be configured to be aligned over a fascial incision using the applicator and affixed under tension to anterior abdominal wall fascia by tissue penetration of the anchoring mechanisms of the one or more fasteners.

Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize inside of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a shaft seal or formation of multiple seals maintaining sterilizing fluid within the container so that areas underneath the shaft seal(s) can also be sterilized.

The present disclosure describes kits for surgical repair of soft tissue defects, including hernias. The kits include any combination of components selected from an implantable sheet, a central tie, a delivery tool, a delivery tool insert configured to be received within the delivery tool, a rolling device, and an insertion member. Packaging for the kits and/or components and methods of using the kits and/or components are also provided.

Packaging for a medical implant such as a hernia repair prosthetic material includes a carrier and a stiffener. The hernia repair prosthetic material is placed adjacent to the stiffener within the carrier. The carrier assembly is sealed within an outer pouch, such as a foil pouch, and sterilized. When the carrier is being removed from the pouch in preparation for surgery, the stiffener helps prevent the carrier assembly from contacting non-sterile portions of the pouch.

An implant insertion device includes: a tubular body having a distal portion that is insertable into subcutaneous tissue and an insertion hole that extends proximally from the distal portion in an axial direction; an elongated implant configured to promote tissue regeneration by attachment of cells; and an elongated body that is accommodated in the insertion hole of the tubular body and is configured to move along the insertion hole of the tubular body and to protrude from the distal portion of the tubular body. The elongated body is configured to advance with respect to the tubular body and thereby push a distal portion of the implant in a distal direction from the insertion hole of the tubular body.

A system for heart valve repair includes a packaging assembly for storing the replacement heart valve. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism. The retention mechanism includes a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly having a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve. The packaging assembly is designed to hold and transport a replacement heart valve and fits within a shipment jar.

A valved conduit including a bioprosthetic valve, such as a heart valve, and a tubular conduit sealed with a bioresorbable material. The bioprosthetic heart valve includes prosthetic tissue that has been treated such that the tissue may be stored dry for extended periods without degradation of functionality of the valve. The bioprosthetic heart valve may have separate bovine pericardial leaflets or a whole porcine valve. The sealed conduit includes a tubular matrix impregnated with a bioresorbable medium such as gelatin or collagen. The valved conduit is stored dry in packaging in which a desiccant pouch is supplied having a capacity for absorbing moisture within the packaging limited to avoid drying the bioprosthetic tissue out beyond a point where its ability to function in the bioprosthetic heart valve is compromised. The heart valve may be sewn within the sealed conduit or coupled thereto with a snap-fit connection.