Abstract: Systems and methods for a multi-layered peel-away sheath assembly for insertion of a blood pump, the peel-away sheath assembly including a sheath hub and a sheath body having a proximal end that is connected to the sheath hub, and a distal end. The sheath body comprises multiple layers including a reinforcing layer. The reinforcing layer improves flexibility and kink resistance of the assembly The reinforcing layer can comprise LCP, PEBAX, stainless steel, Nitinol, or Kevlar. The reinforcing layer may be a laser-cut hypotube or a braided or coiled filament. A first layer material and a third layer material are thermoplastics, including PEBAX or TPU. The reinforcing layer has at least one discontinuity, which is aligned with peel-away lines in the sheath body to allow an operator to peel-away the assembly. The peel-away lines are formed of inner notches, outer notches, or both. The sheath hub also includes a discontinuity to allow the sheath hub to peel-away.

Abstract: Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

Abstract: A positioning device for maintaining positioning of an introducer hub relative to a repositioning sheath or catheter may be provided. The positioning devices may include a first coupler, a second coupler configured to be removably coupled to a portion of a repositioning sheath or catheter that is proximal to the first coupler, and a portion extending between the first coupler and the second coupler, the extension bridge configured to maintain a fixed axial distance between the introducer hub and a proximal end of the repositioning sheath or catheter. A flexible hinge may be incorporated, where a medical device would be configured to pass through the second coupler, the flexible hinge, and the first coupler.

Abstract: A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.

Abstract: A device and method are provided for minimizing and/or preventing limb ischemia, such as when a medical device inserted into a patient's vasculature occludes the vessel. The device may include a tubular member and a first anchor configured to hold a position of the tubular member relative to a vessel. The first anchor is configured to appose an internal wall of the vessel. A second anchor may cooperate with the first anchor to hold the position of the tubular member relative to the vessel.

Abstract: A device and method are provided for minimizing and/or preventing limb ischemia, such as when a medical device inserted into a patient’s vasculature occludes the vessel. The device may include a tubular member and one or more expandable features having metal wires disposed around the tubular member, the one or more wires disposed around the tubular member configured to be expanded at a target site, allowing blood to flow around and past any potentially occluding medical device.

Abstract: Systems and methods for a multi-layered peel-away sheath assembly for insertion of a blood pump, the peel-away sheath assembly including a sheath hub and a sheath body having a proximal end that is connected to the sheath hub, and a distal end. The sheath body comprises multiple layers including a reinforcing layer. The reinforcing layer improves flexibility and kink resistance of the assembly. The reinforcing layer can comprise LCP, PEBAX, stainless steel, Nitinol, or Kevlar. The reinforcing layer may be a laser-cut hypotube or a braided or coiled filament. A first layer material and a third layer material are thermoplastics, including PEBAX or TPU. The reinforcing layer has at least one discontinuity, which is aligned with peel-away lines in the sheath body to allow an operator to peel-away the assembly. The peel-away lines are formed of inner notches, outer notches, or both inner notches and outer notches. The sheath hub also includes a discontinuity to allow the sheath hub to peel-away.

Abstract: Support devices and/or support blocks are provided that support medical devices, such as access devices, at an desired orientation relative to a patient's body. Support blocks may include a bottom surface and a top surface, where the top surface may be configured to be substantially at an angle (such as 5-30 degrees) relative to the bottom surface. The top and/or bottom surface may have a connection mechanism configured to allow the support block to connect with at least one additional support block. The connection mechanism may be, e.g.

Abstract: A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.

Abstract: An access device may be provided that includes a hub configured to improve the flow of blood within a lumen, in order to prevent, e.g., thrombus formation, while also avoiding hemolysis. The hub may have a removably attachable second arm, protrusions/depressions with the lumens of the hub or system, and/or plugs or plug analogs may be used to prevent flow from entering certain regions of the lumens within the hub. These hubs may be used, e.g., as part of an access device, which may have a modular configuration.

Abstract: The present disclosure is drawn to an access device that includes a cannula with a joint lumen therethrough, and a hub coupled to a proximal end of the cannula. The hub includes at least two arms. The first arm may have a first lumen and a first hemostatic valve, the first lumen operably connected to the joint lumen, where the first lumen and the first hemostatic valve are configured for passage of a medical device, and the second arm may be coupled to the first arm and have a second lumen, the second lumen operable connected to the joint lumen, the second arm configured to be operably coupled to an external medical device, such as an extracorporeal membrane oxygenation (ECMO) device.

Abstract: A system for insertion into a vasculature of a patient is disclosed. The system utilizes a primary tubular sheath body coupled to a distal portion of an intermediate tubular sheath body, and a hub coupled to a proximal portion of the intermediate tubular sheath. The hub may be couplable to a dilator via an interaction between a dilator cap and the hub, and the hub may contain a hemostatic valve with a foam member having one or more visibly identifiably regions.

Abstract: A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.

Abstract: A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.

Abstract: A system for providing vascular access in a patient's body may comprise at least one hemostatic valve and at least one clamp to be used with a vascular graft. The vascular graft comprises a tubular body having a proximal end and a distal end, the proximal end being configured to be attached to a vessel in a patient's body. The at least one valve is configured to be attached to the distal end of the graft's tubular body and comprises a housing including a flexible membrane that allows a medical device to be inserted through the membrane into said vascular graft. The valve further comprises an introducer sheath configured to be inserted into the distal end of the graft's tubular body.

Abstract: A system for providing vascular access in a patient's body may comprise at least one hemostatic valve (610) and at least one clamp (210) to be used with a vascular graft (110). The vascular graft (110) comprises a tubular body having a proximal end (110A) and a distal end (110B), the proximal end (110A) being configured to be attached to a vessel in a patient's body. The at least one valve (610) is configured to be attached to the distal end (110B) of the graft's tubular body and comprises a housing (616) including a flexible membrane (611) that allows a medical device (810) to be inserted through the membrane (611) into said vascular graft (110). The valve (610) further comprises an introducer sheath (615) configured to be inserted into the distal end (110B) of the graft's tubular body.

Abstract: Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

Abstract: A sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Abstract: Systems and methods for a multi-layered peel-away sheath assembly for insertion of a blood pump including a sheath hub and a sheath body having a proximal end that is connected to the sheath hub, and a distal end. The sheath body comprises multiple layers including a reinforcing layer. The reinforcing layer improves flexibility and kink resistance of the assembly The reinforcing layer can comprise LCP, PEBAX, stainless steel, Nitinol, or Kevlar. The reinforcing layer may be a laser-cut hypotube or a braided or coiled filament. The first layer material and the third layer material are thermoplastics, including PEBAX or TPU. The reinforcing layer has at least one discontinuity, which is aligned with peel-away lines in the sheath body to allow an operator to peel-away the assembly. The peel-away lines are formed of inner, outer notches, or both. The sheath hub also includes a discontinuity to allow the sheath hub to peel-away.

Abstract: A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.