Abstract: A transcatheter prosthesis includes a stent, a prosthetic valve component, and an anti-paravalvular leakage component. The anti-paravalvular leakage component is coupled to the stent and includes an inner skirt, an outer wrap, a cavity, an opening, and a one-way valve. The inner skirt is disposed on an inner surface of the stent and has an inflow end and a downstream end. The outer wrap is disposed around an outer surface of the stent and has an inflow end coupled to the inflow end of the inner skirt and a downstream end. The cavity is formed between an outer surface of the inner skirt and an inner surface of the outer wrap. An opening is disposed between the inner skirt and the outer wrap. The one-way valve includes a flap at the opening configured to open to allow blood flow into the cavity but prevent blood flow out of the cavity.

Abstract: A transcatheter prosthesis includes a stent, a prosthetic valve component, and an anti-paravalvular leakage component. The anti-paravalvular leakage component is coupled to the stent and includes an inner skirt, an outer wrap, a cavity, an opening, and a one-way valve. The inner skirt is disposed on an inner surface of the stent and has an inflow end and a downstream end. The outer wrap is disposed around an outer surface of the stent and has an inflow end coupled to the inflow end of the inner skirt and a downstream end. The cavity is formed between an outer surface of the inner skirt and an inner surface of the outer wrap. An opening is disposed between the inner skirt and the outer wrap. The one-way valve includes a flap at the opening configured to open to allow blood flow into the cavity but prevent blood flow out of the cavity.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: A transcatheter prosthesis includes a stent, a prosthetic valve component, and an anti-paravalvular leakage component. The anti-paravalvular leakage component is coupled to the stent and includes an inner skirt, an outer wrap, a cavity, an opening, and a one-way valve. The inner skirt is disposed on an inner surface of the stent and has an inflow end and a downstream end. The outer wrap is disposed around an outer surface of the stent and has an inflow end coupled to the inflow end of the inner skirt and a downstream end. The cavity is formed between an outer surface of the inner skirt and an inner surface of the outer wrap. An opening is disposed between the inner skirt and the outer wrap. The one-way valve includes a flap at the opening configured to open to allow blood flow into the cavity but prevent blood flow out of the cavity.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: A capillary tube bundle sub-assembly for use in an extracorporeal heat exchanger includes a continuous capillary tubing wound about a core to define a plurality of capillary layers each including a plurality of capillary segments. The capillary segments each define opposing terminal ends adjacent opposing ends of the core. The capillary segments of each layer are circumferentially aligned relative to an axis of the core, with each successive layer being radially outward of an immediately preceding layer. The capillary segments are non-parallel with the axis, spiraling partially about the axis in extension between the opposing terminal ends. Each capillary segment forms less than one complete revolution (i.e., winds less than 360°). The segments within each layer are substantially parallel with one another; however, an orientation of the segments differs from layer-to-layer such as by pitch or angle.

Abstract: An apparatus for oxygenating blood including a housing and an oxygenator bundle. The housing defines a primary chamber, a blood inlet port open to the primary chamber, and a blood outlet region. The outlet region includes a blood outlet port, an outlet chamber open to the outlet port, and a partition. The partition establishes spaced apart, first and second passageways from the primary chamber to the outlet chamber. The oxygenator bundle is disposed within the primary chamber. A blood flow path is formed from the blood inlet port, through the oxygenator bundle and to the blood outlet port, and includes first and second outlet flow paths within the outlet chamber via the first and second passageways, respectively. The first and second outlet blood flow paths merge at the blood outlet port. A dual port blood outlet is created, increasing mixing of blood immediately upstream of the outlet port.

Abstract: A capillary tube bundle sub-assembly for use in an extracorporeal heat exchanger includes a continuous capillary tubing wound about a core to define a plurality of capillary layers each including a plurality of capillary segments. The capillary segments each define opposing terminal ends adjacent opposing ends of the core. The capillary segments of each layer are circumferentially aligned relative to an axis of the core, with each successive layer being radially outward of an immediately preceding layer. The capillary segments are non-parallel with the axis, spiraling partially about the axis in extension between the opposing terminal ends. Each capillary segment forms less than one complete revolution (i.e., winds less than 360°). The segments within each layer are substantially parallel with one another; however, an orientation of the segments differs from layer-to-layer such as by pitch or angle.

Abstract: An apparatus for oxygenating blood including a housing and an oxygenator bundle. The housing defines a primary chamber, a blood inlet port open to the primary chamber, and a blood outlet region. The outlet region includes a blood outlet port, an outlet chamber open to the outlet port, and a partition. The partition establishes spaced apart, first and second passageways from the primary chamber to the outlet chamber. The oxygenator bundle is disposed within the primary chamber. A blood flow path is formed from the blood inlet port, through the oxygenator bundle and to the blood outlet port, and includes first and second outlet flow paths within the outlet chamber via the first and second passageways, respectively. The first and second outlet blood flow paths merge at the blood outlet port. A dual port blood outlet is created, increasing mixing of blood immediately upstream of the outlet port.

Abstract: A capillary tube bundle sub-assembly for use in an extracorporeal heat exchanger includes a continuous capillary tubing wound about a core to define a plurality of capillary layers each including a plurality of capillary segments. The capillary segments each define opposing terminal ends adjacent opposing ends of the core. The capillary segments of each layer are circumferentially aligned relative to an axis of the core, with each successive layer being radially outward of an immediately preceding layer. The capillary segments are non-parallel with the axis, spiraling partially about the axis in extension between the opposing terminal ends. Each capillary segment forms less than one complete revolution (i.e., winds less than 360°). The segments within each layer are substantially parallel with one another; however, an orientation of the segments differs from layer-to-layer such as by pitch or angle.

Abstract: An apparatus for de-aering, oxygenating and controlling a temperature of blood in an extracorporeal blood circuit. The apparatus includes a housing, a manifold body, a heat exchanger, and an oxygenator. A blood inlet tangentially directs blood into a first chamber of the housing. The manifold body is disposed in a second chamber, and includes a core and a plurality of vanes that define channels. The heat exchanger is arranged around the manifold body, and the oxygenator around the heat exchanger. The channels are open to the heat exchanger. An established blood flow path includes rotational flow within the first chamber to separate air from the blood, generally longitudinal flow from the first chamber and along the channels, and generally radial flow through the heat exchanger and the oxygenator. With this construction, gross air removal occurs prior to the blood passing through the heat exchanger and oxygenator.

Abstract: An apparatus for oxygenating blood including a housing and an oxygenator bundle. The housing defines a primary chamber, a blood inlet port open to the primary chamber, and a blood outlet region. The outlet region includes a blood outlet port, an outlet chamber open to the outlet port, and a partition. The partition establishes spaced apart, first and second passageways from the primary chamber to the outlet chamber. The oxygenator bundle is disposed within the primary chamber. A blood flow path is formed from the blood inlet port, through the oxygenator bundle and to the blood outlet port, and includes first and second outlet flow paths within the outlet chamber via the first and second passageways, respectively. The first and second outlet blood flow paths merge at the blood outlet port. A dual port blood outlet is created, increasing mixing of blood immediately upstream of the outlet port.

Abstract: A capillary tube bundle sub-assembly for use in an extracorporeal heat exchanger includes a continuous capillary tubing wound about a core to define a plurality of capillary layers each including a plurality of capillary segments. The capillary segments each define opposing terminal ends adjacent opposing ends of the core. The capillary segments of each layer are circumferentially aligned relative to an axis of the core, with each successive layer being radially outward of an immediately preceding layer. The capillary segments are non-parallel with the axis, spiraling partially about the axis in extension between the opposing terminal ends. Each capillary segment forms less than one complete revolution (i.e., winds less than 360°). The segments within each layer are substantially parallel with one another; however, an orientation of the segments differs from layer-to-layer such as by pitch or angle.

Abstract: An apparatus for de-aering, oxygenating and controlling a temperature of blood in an extracorporeal blood circuit. The apparatus includes a housing, a manifold body, a heat exchanger, and an oxygenator. A blood inlet tangentially directs blood into a first chamber of the housing. The manifold body is disposed in a second chamber, and includes a core and a plurality of vanes that define channels. The heat exchanger is arranged around the manifold body, and the oxygenator around the heat exchanger. The channels are open to the heat exchanger. An established blood flow path includes rotational flow within the first chamber to separate air from the blood, generally longitudinal flow from the first chamber and along the channels, and generally radial flow through the heat exchanger and the oxygenator. With this construction, gross air removal occurs prior to the blood passing through the heat exchanger and oxygenator.