Percutaneous access devices (PAD) or other implantable medical devices formed with chain mail are provided. The use of chain mail allows for a flexible PAD that promotes the formation of natural biologic seals between the skin and the device to form a barrier to microbial invasion into the body. Percutaneous access devices may be used for cardiac assist systems, peritoneal dialysis catheters, Steinman pin, Kirschner wires, chronic indwelling venous access catheters that require skin penetration, and osseo-integrated percutaneous medical appliances. Unlike conventional chain mail that is only formed in two dimensional sheets, chain mail is formed in elongated linear chains with occasional interlinks, two dimensional sheets, and in other configurations and combinations including three dimensional structures, pendant petals, elongated linear chains, combined fractal structures having a non-integer dimensionality intermediate between 1 and 3, and combinations thereof. Chain mail may be formed of combinations of simpler structures to form higher-order structures.

An intraosseous access system can include a hub coupled to a cannula that can be introduced into a bone of a patient. The system further includes a securement device that can couple with the hub when transitioned from an open orientation to a closed orientation. The securement device includes a first segment and a second segment that are spaced apart from each other when the securement device is in the open orientation and are approximated and secured to each other when the securement device is in the closed orientation. The first segment includes a first receptacle that receives a portion of the hub therein and contacts the hub to restrain movement of the hub relative to the securement device when the securement device is coupled with the hub in the closed orientation. The first segment also includes a first arm coupled to the first receptacle, the first arm biasing the first receptacle toward the hub when the securement device is coupled with the hub in the closed orientation.

This invention concerns improved single use caps or covers for vascular access devices such as needlefree connectors that are used, for example, in intravenous administration sets and extension sets. Removal of a single use cap or cover according to the invention from a vascular access device destroys the cap such that it cannot be reused. Such single use caps and covers will help ensure compliance with infection prevention protocols in healthcare settings, which will assist in reducing the incidence of healthcare-associated infections (HAIs), particularly catheter-related blood stream infections. Assemblies and kits its including such caps and covers, for example, IV administration and extension sets that include one or more needlefree connectors, as well as methods for using such caps and covers, are also described.

An interface device for implantation in a subject includes a tissue integration layer and a crowning element. The tissue integration layer has a porous structure adapted for ingress of tissue to anchor the device when implanted. The crowning element is adapted for epidermal attachment when the device is implanted and is configured such that once implanted, part of the crowning element extends through the epidermis and is accessible from outside the subject's body. The porous structure of the tissue integration layer is interconnected for tissue ingress during implantation.

An interface device for implantation in a subject includes a tissue integration layer and a crowning element. The tissue integration layer has a porous structure adapted for ingress of tissue to anchor the device when implanted. The crowning element is adapted for epidermal attachment when the device is implanted and is configured such that once implanted, part of the crowning element extends through the epidermis and is accessible from outside the subject's body. The porous structure of the tissue integration layer is interconnected for tissue ingress during implantation.

An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises an access pathway and attachment device. The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

Tissue access devices and methods of using and making the same are disclosed. The devices can have a sensor configured to occlude a flow path by deflecting a membrane into the flow path when the devices become dislodged from tissue. The sensor can be configured to partially or fully occlude the flow path. The sensor can have a spring, can be a spring, or may not have a spring. The sensor can be static or can be moved from a sensor first configuration to a sensor second configuration. The membrane can be deflected into the flow path when the sensor is in the sensor second configuration.

This invention provides sterilized vascular access assemblies that include a sterilized needleless access connector (NAC) and a sterilized removable protective cap or cover capping or covering one or both of the NAC's fluid inlet and/or fluid outlet, and methods of making and using such assemblies, advantageously in the context of providing fluids, medication, and/or nutrition to patients in acute or long-term healthcare settings.

A feeding tube aperture supported and aligned with a feeding tube opening in an abdominal wall of a patient, including a base having a first end surface transverse to an axis of the base and a feeding tube, a second opposed end surface, a central feeding tube passage extending between the first and second end surfaces, a plurality of vent passages around the feeding tube passage and extending between the first and second end surfaces, a hollow, cylindrical feeding tube support extension centered on and extending outwardly from the feeding tube passage to support and align the feeding tube aperture, and a plurality of spaced apart resilient spacers extending outwards from the second end surface. The plurality of spaced apart resilient spacers resiliently space the second end surface from the abdominal wall and form a plurality of air passages to allow a flow of air around the abdominal wall and the feeding tube opening.

A therapeutic delivery device that provides a controlled release of high doses of a therapeutic agent in a local area, sustains the high dose controlled release with a percutaneous port for refilling the device, and is versatile for use with multiple types of therapeutic agents and/or implant systems. A rate determining/controlled release membrane is used to decrease the molecular mobility of the therapeutic compounds thereby controlling the therapeutic release profile. The therapeutic delivery device includes a body defining an internal reservoir for receiving a therapeutic agent and including a first membrane for providing a controlled release of the therapeutic agent to the surgical site, a port in fluid communication with the reservoir, a sleeve configured to encapsulate the body, and a rigid housing configured to support the body and a portion of the sleeve, the rigid housing configured to release the body and the sleeve after the body and the sleeve are anchored position relative to the surgical site.