Abstract: A system to optimize the operation of counter pulsatile cardiac assist devices includes a collection of intracorporeal and extracorporeal physiologic sensors that generate data. A control system in electrical communication with the collection of intracorporeal and extracorporeal physiologic sensors generates control signals for the counter pulsatile cardiac assist device based on a counter pulsating aortic pumping element based on the data. A low power transmitter is in electrical communication with the collection of sensors and the control system and sends the generated data and the control signals to an external computer for aggregation and analysis. The analysis is based on a set of inputs from an implanted counter pulsatile cardiac assist devices.

Abstract: A system and method for a modular external interface for a skin penetrating appliance is provided. The modular device prevents internalization of bacteria, other infectious agents, or other unwanted materials from entering the access point for a catheter, Steinman pin, Kirschner wires, or other percutaneous instruments. The modular external interface provides for the hermaticity in the vicinity of the skin-appliance interface with fluid exudate or transudate egressing from the vicinity of the skin-appliance interface. The modular external interface forms a hermetic seal with the external neck of an implanted appliance with a locking feature that joins the main body of the modular external interface together around the neck of the appliance. The modular external interface provides mechanical stability to an implanted appliance so as to speed healing around a semi-permanent implanted appliance, as well as connection points for vacuum lines and drive lines for the insertion of medical devices.

Abstract: A cardiac pump and an assist system is provided that increases blood ejection from a compromised heart. An implantable cardiac pump acting as an assist device provided includes an attachment system and locating features that enable a minimally invasive procedure to implant and deploy one or more aortic blood pumps in a patient. The insertable cardiac pump is replaceable without resort to a conventional open surgical procedure. Monitoring of cardiac pump operation allows for replacement in advance of chamber failure. The dynamics of blood-contacting interface of the cardiac assist device mimic the dynamics of the blood-contacting interface of a naturally occurring left ventricle, thereby minimizing flow-related device-associated pathologic disturbances of intravascular clotting mechanisms.

Abstract: A system for measuring and monitoring wound hermaticity of a patient is provided that includes one or more sensors for measuring parameters that correlate to a degree of wound hermaticity, where the one or more sensors are incorporated into the design of a percutaneous skin access device (PAD), a bone anchor, a wound dressing, or a bandage. The degree of wound hermaticity is related to impedance measurements performed on the patient's skin, via measurements of humidity in a vacuum line to the PAD or the bone anchor, or via measurements of local tissue oxygenation in the immediate vicinity of the PAD or the bone anchor interface with the patient's skin. The hermaticity measurement parameters are communicated by wired or wireless connection to a computing or a communication device for immediate or remote monitoring.

Abstract: An external protective interface is provided for intravenous infusion lines, drive lines, vacuum lines, and monitoring lines for percutaneous access. The interface acts as an airtight seal in concert with a vacuum line to promote accelerated tissue healing to reduce and prevent infection at insertion sites for infusion lines, drive lines, and medical devices. The interface provides additional mechanical stability to an implanted tube or PAD or so as to speed healing around a semi-permanent implanted tube or PAD, as well as connection points for vacuum lines and at least one drive line for the insertion of medical devices. The dense fibroblast ingrowth encouraged by the interface acts to strengthen barriers to infection at the insertion site.

Abstract: An integrated multi-lumen tubing includes two or more lumens. A webbing is provided between each of said two or more lumens and holding the two or more lumens together as a ribbon. A set of terminations are provided at opposing ends of each of the two or more lumens. A sheath can also be provided surrounding the two or more lumens. A system for supply of intravenous fluid and vacuum to a patient includes the aforementioned integrated multi-lumen tubing. An intravenous bag or bottle is provided that is in fluid communication with an infusion pump. The integrated multi-lumen tubing connects the infusion pump and a vacuum pump to a percutaneous access device (PAD). A method of using said integrated multi-lumen tubing to delivery simultaneously two or more inputs into a subject in need thereof is also provided.

Abstract: A luminal access device is provided that includes a luminal graft attached to a patient lumen. A percutaneous access device (PAD) is coupled to the luminal graft and adapted to stabilize a conduit in fluid communication with the luminal graft and an external medical device. A portion of said PAD adapted to be external to the patient and seal around said conduit. Infectious agent penetration at an insertion site of the PAD is reduced by providing a porous inner sleeve fluidly connected to a conduit. A vacuum or hydrodynamic source is fluidly connected to the conduit to create a fluid draw from the subject tissue through the inner sleeve to the conduit. The conduit is readily formed to have a bore and an outer conduit surface, the outer conduit surface being optionally nanotextured. The conduit bore is adapted to accommodate a medical appliance.

Abstract: A device for reducing agent penetration at an insertion site is provided that has a porous inner sleeve fluidly connected to a conduit. A vacuum or hydrodynamic source is fluidly connected to the conduit. The device is stabilized by fibroblast in-growth and inhibits bacterial colonization. A device is also provided that has a conduit having a bore and an outer conduit surface. The outer conduit surface is optionally nanotextured to promote fibroblast adhesion and limit bacterial residency. A sleeve is provided in fluid communication with the bore of the conduit, and is formed from materials characterized by a pore matrix through which vacuum or hydrodynamic draw is achieved in a process to promote stabilization and reducing bacterial colonization by draw fluid from an area around the surrounding the site of the device. The sleeve optionally has a distal nanotextured surface.

Abstract: A device for reducing agent penetration at an insertion site is provided that has a porous inner sleeve fluidly connected to a conduit. A vacuum or hydrodynamic source is fluidly connected to the conduit. The device is stabilized by fibroblast in-growth and inhibits bacterial colonization. A device is also provided that has a conduit having a bore and an outer conduit surface. The outer conduit surface is optionally nanotextured to promote fibroblast adhesion and limit bacterial residency. A sleeve is provided in fluid communication with the bore of the conduit, and is formed from materials characterized by a pore matrix through which vacuum or hydrodynamic draw is achieved in a process to promote stabilization and reducing bacterial colonization by draw fluid from an area around the surrounding the site of the device. The sleeve optionally has a distal nanotextured surface.

Abstract: A cardiac assist device is provided that can be deployed in any region of the aorta by minimally invasive techniques by the way of an inventive fastener that affixes the device to the aorta wall at the site of an aortonomy. The devices and methods described herein allow for improved patient outcome.

Abstract: A biocompatible implantable bone anchor is provided that has a threaded first portion that engages and anchors into a bone. The implant also has a neck region extending from the first portion adapted to promote autologous cell growth thereon at an interface of the bone and one or more epidermal or gum layers, the neck region having a plurality of channels extending about the neck region. The neck region is configured to mechanically engage at least one of an abutment, dental restoration, or osseous device attachment. An in situ bone anchor cell growth assembly includes the bone anchor and a manifold encompassing the neck portion so as to form a seal therebetween and a route of fluid communication between a manifold inlet and at least one of said plurality of channels. A process for growing autologous cells on a neck region of a bone anchor is provided.