Abstract: A compliant blood gas exchanger is provided including a housing having a first end cap, a second end cap, and an elastomeric sidewall or sleeve extending there between forming a chamber. A hollow fiber assembly is disposed in the chamber. The hollow fiber assembly has a first mounting collar, a second mounting collar and a plurality of hollow fibers disposed there between. The first end cap is disposed in communication with the first mounting collar and the second end cap is disposed in communication with the second mounting collar. The end caps are connected to a gas inlet and a gas outlet. The chamber is in communication with a blood inlet and a blood outlet. The elastomeric sidewall is responsive to internal and external pressures affecting the chamber. The first chamber can also be placed adjacent to a second chamber and both chambers placed within a rigid outer housing. Thus, a dual-chamber pulsatile blood gas exchanger can be provided.

Abstract: A compliant blood gas exchanger is provided including a housing having a first end cap, a second end cap, and an elastomeric sidewall or sleeve extending there between forming a chamber. A hollow fiber assembly is disposed in the chamber. The hollow fiber assembly has a first mounting collar, a second mounting collar and a plurality of hollow fibers disposed there between. The first end cap is disposed in communication with the first mounting collar and the second end cap is disposed in communication with the second mounting collar. The end caps are connected to a gas inlet and a gas outlet. The chamber is in communication with a blood inlet and a blood outlet. The elastomeric sidewall is responsive to internal and external pressures affecting the chamber. The first chamber can also be placed adjacent to a second chamber and both chambers placed within a rigid outer housing. Thus, a dual-chamber pulsatile blood gas exchanger can be provided.

Abstract: The present invention is directed to multifunctional thrombo-resistant coatings for use with biomedical devices and implants, such as a coating which includes a siloxane surface onto which a plurality of amine functional groups have been bonded. Covalently bonded to the amine functional groups are a plurality of poly(ethylene oxide) chains, such that a single poly(ethylene oxide) chain is bonded to a single amine functional group. A plurality of different bioactive molecules, designed to counteract specific blood-material incompatibility reactions, are covalently bonded to poly(ethylene oxide) chains, such that a single bioactive molecule is coupled to a single polyethylene oxide chain.The methods of manufacturing the present invention include preparing a material having a siloxane surface onto which a plurality of amine functional groups have been bonded. This is achieved by plasma etching with ammonia gas or by plasma polymerization of a siloxane monomer in the presence of ammonia gas.

Abstract: The present invention is directed to multifunctional thrombo-resistant coatings for use with biomedical devices and implants, such as a coating which includes a siloxane surface onto which a plurality of amine functional groups have been bonded. Covalently bonded to the amine functional groups are a plurality of poly(ethylene oxide) chains, such that a single poly(ethylene oxide) chain is bonded to a single amine functional group. A plurality of different bioactive molecules, designed to counteract specific blood-material incompatibility reactions, are covalently bonded to poly(ethylene oxide) chains, such that a single bioactive molecule is coupled to a single polyethylene oxide chain.The methods of manufacturing the present invention include preparing a material having a siloxane surface onto which a plurality of amine functional groups have been bonded. This is achieved by plasma etching with ammonia gas or by plasma polymerization of a siloxane monomer in the presence of ammonia gas.

Abstract: An extracorporeal blood oxygenation device having a sealed casing containing a bundle comprised of a plurality of gas permeable tubes for efficient gas transfer. The bundle is woven from tubes having at least two different sizes, at least the smaller diameter tubes being gas permeable. The tubes are relatively non-thrombogenic and are open at each end to an enclosed annular chamber having attached input and output fittings. Oxygen-rich gas flows into one annular chamber through an input fitting before flowing through the gas permeable tubes. Venous blood to be oxygenated is introduced into the sealed casing directly into the center of the bundle for dispersement radially outward through the bundle and across the gas permeable tubes wherein the blood comes in contact with the membrane surface of the gas permeable tubes and exchanges carbon dioxide for oxygen across that surface before being collected from around the perimeter of the bundle for return to the patient.

Abstract: The present invention is directed to multifunctional thrombo-resistant coatings for use with biomedical devices and implants, such as a coating which includes a siloxane surface onto which a plurality of amine functional groups have been bonded. Covalently bonded to the amine functional groups are a plurality of poly(ethylene oxide) chains, such that a single poly(ethylene oxide) chain is bonded to a single amine functional group. A plurality of different bioactive molecules, designed to counteract specific blood-material incompatibility reactions, are covalently bonded to poly(ethylene oxide) chains, such that a single bioactive molecule is coupled to a single polyethylene oxide chain. The method of manufacturing the present invention include preparing a material having a siloxane surface onto which a plurality of amine functional groups have been bonded. This is achieved by plasma etching with ammonia gas or by plasma polymerization of a siloxane monomer in the presence of ammonia gas.

Abstract: A sheath and obturator is provided for facilitating the insertion of certain medical devices into a patient's vascular system, a vein, or venous system and in particular an in vivo extrapulmonary blood gas exchange device having a bundle comprised of a plurality of elongated gas permeable tubes being potted at each end and enclosed within a respective air tight proximal and distal chamber. The sheath is hollow and substantially tubular with a tapered receiving portion and a nontapered, curved entry portion. The obturator has a tip at the distal end of the obturator and a trip at the proximal end with an elongate member therebetween. The sheath is configured to receive the obturator in sliding engagement such that when the obturator is fully inserted within the sheath, the tip closes the opening at the entry end of the sheath and protrudes slightly therefrom. The obturator has a vent which provides a passage from space exterior to the sheath into the hollow interior of the sheath.

Abstract: An in vivo extrapulmonary blood gas exchange device is disclosed having a hollow fiber bundle in gaseous communication with a coaxial dual lumen tube and having a furling apparatus for twisting one coaxial lumen relative to the other. The furling apparatus enables the outside diameter of the bundle of gas permeable tubes to be selectively adjusted to provide either a furled, small insertion diameter when inserting the apparatus into the venae cavae of a patient or an unfurled, expanded oxygenation diameter after the apparatus is in place within the venae cavae and the bundle of gas permeable tubes is deployed therein. The oxygenator is inserted into the patient through a single incision at one of the right external iliac, common femoral, or internal jugular veins. A novel distal tip configuration permits the oxygenator to be inserted into the patient utilizing an over-the-guidewire intravascular insertion technique.

Abstract: An in vivo extrapulmonary blood gas exchange device having a bundle comprised of a plurality of elongated gas permeable tubes being bound at each end and enclosed within a respective air tight proximal and distal chamber. A dual lumen tube having an outer lumen and an inner lumen is situated relative to the gas permeable tubes such that the outer lumen terminates within the proximal chamber and such that the inner lumen terminates within the distal chamber. The apparatus includes means for selectively adjusting the overall, outside diameter of the bundle of gas permeable tubes to provide either a furled, small insertion diameter when inserting the apparatus into the venae cavae of a patient or an unfurled, expanded oxygenation diameter after the apparatus is in place within the venae cavae and the bundle of gas permeable tubes is deployed therein. The apparatus is inserted into the patient through a single incision at one of the right external iliac, common femoral or internal jugular veins.

Abstract: A fully portable, semi-automatic mechanical heart-lung substitution system and method. The system includes a venous cannula adapted for insertion into the vena cava of the patient and an arterial cannula adapted for insertion into the right and/or left common carotid artery of the patient. The venous cannula is attached to a roller pump used to pump blood from the patient's right heart to a membrane oxygenator. The speed of the roller pump is automatically controlled by means of a pressure sensor that is attached to the outer wall of the venous cannula so as to sense the internal venous blood pressure inside the patient's vena cava. Blood flows from the oxygenator to a compliance reservoir which expands so as to create increasing pressure within the reservoir as the volume of blood filling the reservoir increases.

Abstract: A method and apparatus for the in vivo oxygenation of blood without using or disturbing the patient's lungs. The apparatus comprises a plurality of small diameter gas permeable tubes connected to headers at each end. The headers in turn are connected on one end to a source of oxygen rich gas and on the other end to an exhaust means. The apparatus is positioned within the circulatory system of a patient. Particularly, an incision is made in the patient's femoral or iliac vein and the apparatus is threaded through the venae cavae and eventually out an incision in the patient's jugular vein. Both headers are positioned so that a source of oxygen rich gas can be attached and the gas circulated through the device.

Abstract: A cannula suitable for total bypass procedures in arterial and venous cannulation for extracorporeal perfusion of blood. The cannula has a tapered body of sufficient length for peripheral cannulation and openings through the cannula wall appropriately positioned to provide fluid transfer at various anatomical diversion sites within a patient's circulatory system in accordance with flow requirements necessary to maintain proper circulation is disclosed. The cannula structure can be adapted for bidirectional as well as unidirectional flow to maintain circulation in extremities otherwise ignored by single-directional flow cannulation. Reinforcing structure is disclosed for developing the required strength characteristics for the cannula wall, particularly for arterial applications.