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: A wound management system (WMS) is provided that includes dressings, bandages, or implantable medical devices that are equipped with filters, environmental controls, and sensors that promote the formation of a natural biologic seal between the skin and the dressing to form a barrier to microbial invasion into the body that accelerates healing and mitigates wound or exit site infection. Percutaneous access devices (PAD) used with the WMS or other devices including peritoneal dialysis (PD) catheters, Steinman pin, Kirschner wires, and chronic indwelling venous access catheters that require skin penetration. The WMS minimizes risk of exit site infection by reducing the bioburden in the exit tunnel environment in the acute and subacute phases of the PD catheter post-implant. Visualization of the wound without taking off the dressing is provided via a window in the wound area or exit-site to visually monitor for signs of infection and the presence of exudate.

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 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: 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 method of modulating oxygen saturation levels can include measuring oxygen saturation levels in a patient, administering inhaled nitric oxide, adjusting the dose of oxygen in real time to a second dose based on the inhaled nitric oxide.

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: A percutaneous access device (PAD) is provided with a reduced likelihood of dislodgment that requires a reduced implantation incision so as to increase the rate of healing and reducing related infection. The PAD has a transdermal anchor in the form of flanged wings that are deployed following the implantation of the device in a patient. A deployment tool is provided to insert the PAD into the subject, and to actuate the flanges. The deployment tool protects the surface of the PAD with an outer cylindrical wall during insertion. The deployment tool has a stabilizer handle that is keyed with a key for insertion into the body or channel of the PAD. The stabilizer key stabilizes the PAD and prevents the PAD from rotating when the outer cylinder is rotated to turn an intermediate disc ring to actuate the flanges outward.

Abstract: Various systems generating nitric oxide are disclosed herein. According to one embodiment, the system includes a first gas source providing nitrogen dioxide mixed in air or oxygen, and a second gas source supplying compressed air and/or compressed oxygen. The system also includes a ventilator coupled to the first and second gas sources, wherein the ventilator is resistant to nitrogen dioxide. The ventilator regulates gas flow and allows for the adjustment of nitrogen dioxide concentration in the gas flow. The system further includes one or more conversion devices operably coupled to the ventilator where the conversion devices convert nitrogen dioxide into nitric oxide. A patient interface delivers nitric oxide to the patient and is operably coupled to the conversion devices. The system allows oxygen and nitric oxide levels to be varied independently.

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: An apparatus for delivering NO includes a nitric oxide-releasing agent, a reactor cartridge containing a reducing agent that coverts a nitric oxide-releasing agent to nitric oxide (NO), a portable console, and a respiratory assist device configured to deliver the NO.

Abstract: The invention relates to a pump-inflow-cannula (1) providing a blood conduit from a heart (2) and/or from an associated vessel to an external blood handling system. The pump-inflow-cannula comprises a body (3), encompassing an essentially axially extending inflow-lumen (4), having a distal-end (5) for an attachment of the inflow-lumen (4) to the blood handling system, and having a proximal-end (6) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at least one projection (7) is provided at the proximal-end (6) to deflect a heart muscle from intruding into the inflow-lumen (4), wherein the body (3) of the pump-inflow-cannula comprises a reinforcement-means (8). The invention is also related to a pump-outflow-cannula (19) and to a blood managing system comprising a pump-inflow-cannula and a pump-outflow-cannula in accordance with the present invention.

Abstract: A method of providing a therapeutic composition includes administering a ROS reducing drug, calcium channel blocker, anti-fibrotic, anti-inflammatory, or anti-hypertensive drug and administering inhaled nitric oxide and reducing symptoms of oxidative stress and/or fibrosis in a patient.

Abstract: A method of improving hemodynamics includes identifying a mammal having or at risk of developing a vascular depletion of nitric oxide due to nitric oxide scavenging by oxyhemoglobin, and introducing nitric oxide into the mammal's circulation.

Abstract: A method of modulating oxygen saturation levels can include measuring oxygen saturation levels in a patient, administering inhaled nitric oxide, adjusting the dose of oxygen in real time to a second dose based on the inhaled nitric oxide.

Abstract: A method of modulating oxygen saturation levels can include measuring oxygen saturation levels in a patient, administering inhaled nitric oxide, adjusting the dose of oxygen in real time to a second dose based on the inhaled nitric oxide.

Abstract: Various systems generating nitric oxide are disclosed herein. According to one embodiment, the system includes a first gas source providing nitrogen dioxide mixed in air or oxygen, and a second gas source supplying compressed air and/or compressed oxygen. The system also includes a ventilator coupled to the first and second gas sources, wherein the ventilator is resistant to nitrogen dioxide. The ventilator regulates gas flow and allows for the adjustment of nitrogen dioxide concentration in the gas flow. The system further includes one or more conversion devices operably coupled to the ventilator where the conversion devices convert nitrogen dioxide into nitric oxide. A patient interface delivers nitric oxide to the patient and is operably coupled to the conversion devices. The system allows oxygen and nitric oxide levels to be varied independently.

Abstract: The invention relates to a pump-inflow-cannula (1) providing a blood conduit from a heart (2) and/or from an associated vessel to an external blood handling system. The pump-inflow-cannula comprises a body (3), encompassing an essentially axially extending inflow-lumen (4), having a distal-end (5) for an attachment of the inflow-lumen (4) to the blood handling system, and having a proximal-end (6) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at least one projection (7) is provided at the proximal-end (6) to deflect a heart muscle from intruding into the inflow-lumen (4), wherein the body (3) of the pump-inflow-cannula comprises a reinforcement-means (8). The invention is also related to a pump-outflow-cannula (19) and to a blood managing system comprising a pump-inflow-cannula and a pump-outflow-cannula in accordance with the present invention.

Abstract: The invention relates to a pump-inflow-cannula (1) providing a blood conduit from a heart (2) and/or from an associated vessel to an external blood handling system. The pump-inflow-cannula comprises a body (3), encompassing an essentially axially extending inflow-lumen (4), having a distal-end (5) for an attachment of the inflow-lumen (4) to the blood handling system, and having a proximal-end (6) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at least one projection (7) is provided at the proximal-end (6) to deflect a heart muscle from intruding into the inflow-lumen (4), wherein the body (3) of the pump-inflow-cannula comprises a reinforcement-means (8). The invention is also related to a pump-outflow-cannula (19) and to a blood managing system comprising a pump-inflow-cannula and a pump-outflow-cannula in accordance with the present invention.