Abstract: Vacuum dressings with a guide tube are provided for implantable medical devices that inhibit infection associated with in-dwelling devices while encouraging healing of the incision around the device. The vacuum dressings mitigate pooling of fluids that harbor bacteria from between the outer diameter of an inserted implantable medical device and the inner diameter of a guide tube and also in the cylindrical gap, between the outer diameter of an inserted implantable medical device and the inner wall of the subcutaneous tunnel, which remains in fluid communication with skin microflora. Implantable medical devices may also illustratively include a variety of catheters, such as venous access, peritoneal dialysis, and other indwelling venous access catheters that require skin penetration; cannulas; Steinman pins; Kirschner wires; and cardiac assist device lines.

Abstract: Percutaneous access devices (PAD), bandages, or other implantable medical devices are provided that are equipped with filters, environmental controls, and sensors that promote the formation of a natural biologic seal between the skin and the device to form a barrier to microbial invasion into the body. Levels of humidity and pressure are monitored and dynamically controlled to optimize wound closure about an implanted device or when a PAD is not present a wound itself. Methods and systems for actively assessing wound closure are incorporated into the design of percutaneous skin access devices (PAD), bone anchors, or a wound dressing or bandage alone without at PAD. Pressure and humidity sensors provide active feedback for making changes to the ecology of the wound site or PAD insertion site. A filter is used to aerate the wound while also preventing pathogens in the ambient air from reaching the wound.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of ±1.0 mm and ±1.0°, or better in patient tissue.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of ±1.0 mm and ±1.0°, or better in patient tissue.

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 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: 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.

Abstract: A deployment system and method of use thereof is provided for an interior driveline that mitigates the risk of infections for a variety of implanted medical appliances with a percutaneous conduit. The interior driveline and driveline deployment system allow for the deployment of a driveline and an optional corresponding percutaneous access device (PAD) from within the tissue layers below the dermis, prior to exiting the body of a patient. The interior introduction of the driveline and corresponding PAD precludes entrainment introduction of exogeneous pathogens associated with the traditional approach for insertion of a driveline with an exterior to interior directionality relative to the subject corpus.

Abstract: Medical dressings are provided that minimize the disruptive forces directed at the device-skin interface during the processes of dressing changes. The instantaneous disruptive force, imparted to a healing skin wound by an adhesive dressing as it is being de-adhesed from the vicinity of the skin wound, is determined, in part, by the yield strength (force/unit area) of the adhesive/skin interface and, in part, by that portion of surface area (area) of skin-dressing adhesion participating in traction of the skin at said instant. A method to minimize the disruptive force of a medical dressing is to reduce the surface area of skin-dressing adhesion being de-adhesed at a specific instant by dividing the total surface area of skin-dressing into substantially smaller subareas, each of which, when being de-adhesed, would impart disruptive forces to the healing skin wound which are smaller than the tensile strength of the skin wound.

Abstract: A cardiac pump and an assist system is provided to increase blood ejection from a compromised heart. An implantable cardiac pump acting as an assist device 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 cardiac pumps are replaceable without resort to a surgical procedure. Monitoring of cardiac pump operation allows for replacement in advance of chamber failure. The cardiac pump and assist system do not appreciably sheer blood being accelerated through inflation-deflation cycling so as to limit clot associated side effects of operation of a cardiac assist device.

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: An intra-aortic balloon pump (IABP) is provided that has a series of spiral pleats that function to control the wash of blood associated with an inflation cycle. Additionally, the torsional expansion increases the net efficiency of the IABP relative to a conventional cylindrically shaped balloon. The inflating membrane is textured to promote natural growth of a biologic lining on the surface of the indwelling pump to reduce the need for anticoagulation and the risk of thromboembolic events; promote washing of the surface to minimize stasis and thrombus formation; minimize strain on the IABP; minimize elongation radially and longitudinally to avoid fatigue of the IABP; minimize stretching and stress distribution along a balloon; promote a sweeping effect through the channels in the non-expanded state to wash the surface; or a combination thereof.

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: An inventive digestive tract barrier includes a material defining dimensions of a tube sized to deploy within the digestive tract of a subject. The material or stitches that make up the barrier disintegrate in a controlled manner. The disintegration precludes the need for a surgical procedure to retrieve the barrier and allows for increased nutritional absorption after behavior modification has occurred. Through the inclusion of opening or fenestrations in the barrier, bile flow and nutrition absorption are facilitated. Disintegration is facilitated by formation of the barrier from biodegradable material, stitching non-degradable swatches with disintegrating stitching, or the use of a MEMS cutter. A digestive barrier coated on either the interior or exterior of the tube facilitates management of conditions such as obesity, colitis, and Crohn's disease.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of ±1.0 mm and ±1.0°, or better in patient tissue.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of 1.0 mm and 1.0?, or better in patient tissue.

Abstract: An automated system for medical billing is provided that includes one or more radio frequency identification (RFID) sensors positioned in various rooms or areas of a medical facility. The RFID sensors are in communication with a setS of individually coded radio frequency identification (RFID) tags assigned to each member of a team of healthcare workers, pieces of equipment, and patients seeking medical care in the medical facility. A software platform run on a processor determines probable tasks performed by the members of the healthcare team based on the locations and time spent by the healthcare members with the one or more pieces of equipment and the one or more patients being attended to, and where the determined probable tasks are associated with a corresponding billing codes. A method of system usage is also provided.