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Publication Number

US-11298451-B2

Patent

Publication Date

2022-04-12

Expiration Date


Abstract

A hemodialysis vascular access device includes a proximal end sized and shaped to sealably couple to a hemodialysis catheter, a movable structure coupled to the proximal end, a fixation structure coupled to the movable region and sized and shaped for fixation on a patient, an elongated sleeve coupled to the fixation structure and sized and shaped for insertion into a patient's vasculature, and a valve at a distal end of the internal lumen. When a hemodialysis catheter is inserted into the device and coupled to the proximal end, distal movement of the proximal end relative to the fixation structure biases a distal end of the hemodialysis catheter from a position inside the elongated sleeve through a valve out of the device and into the patient's blood.

Core Innovation

The invention relates to a hemodialysis vascular access device that houses a hemodialysis catheter inside an elongated sleeve between dialysis sessions. The device includes a proximal orifice and a distal orifice, with an elongated catheter body defining a proximal portion and a distal portion, and with proximal and distal lumens configured to receive the catheter through the proximal orifice. The proximal end is configured to be connected to the catheter, while the proximal portion comprises a compressible section that allows axial displacement of the proximal orifice toward the distal portion from a first position to a second position.

When the proximal orifice is displaced toward the distal portion, the distal end of the catheter extends beyond the distal orifice, and the compressible section includes a balloon sized and shaped to at least partially inflate when the proximal orifice is displaced. In use, the device biases the catheter distally through a distal valve into the bloodstream, while during non-use the catheter is retracted back into the sleeve.

The disclosed device also implements distal protection and valving through a distal valve and multiple valve embodiments, including leaflet valves, split valves, balloon-sealed distal tip configurations, and annular balloons. The compressible section and surrounding structures may include air-permeable or antimicrobial membranes, pleated/accordion material, spring-based structures, and protective cover features, and a tube-assembly embodiment that includes a tube with a movable component disposed inside the tube to enable movement of the proximal orifice.

Claims Coverage

The partial claims content includes two independent claims that share a common device architecture: proximal and distal orifices communicating with proximal and distal lumens in an elongated catheter body, and a compressible section that enables axial displacement of the proximal orifice to extend and retract the catheter distal end. Across the two independent claims, the inventive features include the balloon-based compressible section and, in one independent claim, a tube assembly with an internal movable component that enables the proximal orifice movement.

Balloon-based compressible section for axial displacement extending distal catheter end

A proximal portion comprising a compressible section to allow the proximal orifice to be axially displaceable toward the distal portion from a first position to a second position, causing a distal end of the catheter to extend beyond the distal orifice when the proximal orifice is in the second position, wherein the compressible section includes a balloon sized and shaped to at least partially inflate when the proximal orifice is displaced toward the distal portion.

Tube assembly with internal movable component enabling proximal orifice movement

The proximal portion comprising a compressible section to allow the proximal orifice to be axially displaceable toward the distal portion from a first position to a second position, causing a distal end of the catheter to extend beyond the distal orifice when the proximal orifice is in the second position; wherein the compressible section further comprises a tube assembly comprising a tube and a moveable component disposed inside the tube to allow the proximal orifice to move from the first position to the second position.

Overall, the independent claims cover a vascular access device with proximal/distal orifices and lumens in an elongated catheter body, where a compressible section axially displaces the proximal orifice to extend the catheter distal end beyond the distal orifice. The claim set further differentiates implementations by requiring a balloon that at least partially inflates in one independent claim, and by specifying a tube assembly with an internal moveable component in the other independent claim.

Stated Advantages

Protecting against fibrin sheath/thrombus occlusion.

Documented Applications

Hemodialysis vascular access device that houses a hemodialysis catheter inside an elongated sleeve between dialysis sessions, biasing distal extension during use and retracting during non-use.

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