Vascular access devices with self-sealing valves
AssigneeIcahn School of Medicine at Mount Sinai
InventorsEvren AZELOGLU, Eric LIMA
Life of this patent
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Abstract
A vascular access device is implanted under the skin directly over a vascular structure, such as a blood vessel that makes up the arteriovenous (AV) fistula. The vascular access device is designed such that insertion of and the travel of a needle, such as a standard dialysis needle, within a needle access channel urges a displaceable valve to an open position and removal of the dialysis needle from the channel results in the valve automatically closing and sealing the wound, thereby preventing back-bleeding.
Claims42
A self-sealing vascular access device comprising:
- an implantable base having a top surface and an opposite bottom surface, the implantable base having a valve compartment defined therein, the implantable base having a needle access channel formed therein and open along the top surface and the bottom surface, the valve compartment being open to the needle access channel;
- and
- a displaceable valve that is disposed within the valve compartment and movable between a lowered position in which the displaceable valve blocks the needle access channel and a raised position in which the displaceable valve is spaced from the needle access channel resulting in opening of the needle access channel.
A self-sealing vascular device comprising:
- an implantable perforated base having a top surface and an opposite bottom surface, the implantable base having a valve compartment defined therein and being open along the top surface of the implantable base, the implantable base having a needle access channel formed therein that is open at a first end along the top surface and is open at a second end along the bottom surface, the valve compartment being open to the needle access channel, wherein the opening at the first end of the needle access channel is spaced from the opening of the valve compartment along the top surface, wherein the needle access channel is defined by a plurality of needle guide rails that are arranged in a circumferential manner to define an open center configured to permit passage of a needle, the plurality of needle guides being spaced apart along a substantial length thereof to define open spaces for tissue ingrowth;
- and
- a displaceable valve that is disposed within the valve compartment and accessible along the top surface of the implantable base and being movable between a lowered position in which the displaceable valve blocks the needle access channel and a raised position in which the displaceable valve is spaced from the needle access channel resulting in the needle access channel being fully open.
A method of delivering a needle to a vascular site comprising the steps of:
- implanting a self-sealing vascular device below subcutaneous tissue above the vascular site, the self-sealing vascular device having an implantable base having a top surface and a valve compartment defined therein and being open along the top surface of the implantable base, the implantable base having a needle access channel formed therein that is open at a first end along the top surface and is open at a second end along the bottom surface, the valve compartment being open to the needle access channel, the self-sealing device having a displaceable valve that is disposed within the valve compartment and accessible along the top surface of the implantable base, whereby pressure exerted by the overlying subcutaneous tissue causes the displaceable valve to assume a lowered position in which the displaceable valve blocks the needle access channel;
- and
- inserting the needle within the needle access channel and advancing the needle to urge the displaceable valve to a raised position which opens up the needle access channel and permits advancement of the needle to the vascular site, whereby removal of the needle from the needle access channel automatically causes the displaceable valve to move to the lowered position to block and seal the needle access channel.
A method of delivering a needle to a vascular site comprising the steps of:
- implanting a self-sealing vascular device below subcutaneous tissue above the vascular site, the self-sealing vascular device having an implantable base having a top surface and a valve compartment defined therein and being open along the top surface of the implantable base, the self-sealing device having a displaceable valve that is disposed within the valve compartment and accessible along the top surface of the implantable base, whereby pressure exerted by the overlying subcutaneous tissue causes the displaceable valve to assume a lowered position in which the displaceable valve blocks seals a needle access channel formed in the implantable base;
- and
- inserting the needle within the needle access channel and advancing the needle to urge the displaceable valve to a raised position which opens up the needle access channel and permits advancement of the needle to the vascular site, whereby removal of the needle from the needle access channel automatically causes the displaceable valve to move to the lowered position to block and seal the needle access channel.
A method of delivering a needle to a vascular site and automatically sealing the vascular site when the needle is removed from the vascular site, the method comprising the steps of:
- positioning and securing a bottom valve seat component to a vessel wall, the bottom valve seat component including a baseplate in which a needle exit opening is formed and through which the needle can exit and a valve seat surrounds the needle exit opening,
- implanting a self-sealing vascular device below subcutaneous tissue above the vascular site by attaching an implantable base of the device to the baseplate, the implantable base having a needle access channel formed for receiving and permitting passage of the needle through the implantable base to the vascular site;
- and
- inserting the needle within the needle access channel and advancing the needle to urge a displaceable valve to a raised position which causes the subcutaneous tissue to locally deform and store energy, whereby removal of the needle from the needle access channel automatically causes the displaceable valve to move to a lowered position to block and seal the needle access channel as a result of downward pressure exerted by the overlying subcutaneous tissue on the displaceable valve as the stored energy is released.
Dependencies are inferred from the claim text.