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Publication Number
US-10702688-B2
Publication Date
2020-07-07
Expiration Date
Abstract
A system and method are provided for vascular access, enabling repetitive vascular access while preventing damage to the blood vessel wall, reducing hematomas, improving flow in a vessel, preventing back-wall perforation, and enabling improved fistula maturation and care. The system includes an implanted conduit that is incorporated into surrounding fibrous tissue that can guide a needle and/or catheter from a puncture site on the skin to a vessel wall, which may be used to provide repetitive vascular access for persons requiring hemodialysis or chemotherapy.
Core Innovation
The invention provides an under skin implanted vascular access device for accessing a blood vessel. The device includes a body with a lumen passing through the body from a first end to a second end opposite the first end, a first opening through the first end to the lumen, and a second opening through the second end to the lumen. The lumen is sized and shaped to direct a tip of a dialysis needle entering through the first opening to exit through the second opening.
The device couples to an outer wall of the blood vessel at a vessel interface surrounding the second opening and to a dermal layer of skin at a skin interface surrounding the first opening. The vessel interface and the skin interface are on opposite ends of the body, establishing an under skin access configuration with the dialysis needle entering and exiting via the two openings aligned by the lumen.
The document describes features to promote tissue ingrowth and device fixation and features to limit undesired fluid leakage. It describes multiple porous or through-hole structures with through-hole dimensions and surface coverage to promote fibrous tissue ingrowth and to help prevent back-wall perforation and back bleeding.
Attachment and stabilization structures include footplates, suturing apertures, and wings to prevent rotation, and functional elements can include a one-way valve or a sealed barrier associated with back bleeding prevention.
Claims Coverage
The partial content includes two independent claims: a device claim and a method claim. Across these independent claims, the coverage centers on the under-skin access device geometry and interfaces that couple to a blood vessel outer wall and to a dermal skin layer, with additional claimed aspects in the method claim focusing on the attaching steps to establish access.
Under-skin vascular access device with lumen-directed dialysis needle path
A vascular access device for accessing a blood vessel, adapted to couple to an outer wall of the blood vessel and a dermal layer of the skin, comprising a body with a lumen passing through the body from a first end to a second end, a first opening through the first end to the lumen, and a second opening through the second end to the lumen, wherein the lumen is sized and shaped to direct a tip of a dialysis needle entering through the first opening to exit through the second opening; a vessel interface surrounding the second opening for attachment to the outer wall of the blood vessel; and a skin interface surrounding the first opening for direct attachment to the dermal layer of the skin underneath the dermal layer of the skin, with the vessel interface and skin interface on opposite ends of the body.
Method using under-skin access device by attaching vessel and skin interfaces
A method of providing access to a blood vessel utilizing an under skin access device including a body and a lumen passing through the body from a first opening at a first end to a second opening at a second end, the first end including a skin interface surrounding the first opening and the second end including a vessel interface surrounding the second opening, comprising attaching the vessel interface to an outer wall of the blood vessel; and directly attaching the skin interface to a dermal layer of a skin underneath the dermal layer of the skin of a subject.
Together, the independent claims define an under-skin implanted vascular access device that couples a lumen-directed dialysis needle path between a skin interface opening and a vessel interface opening, and a corresponding method of providing access by attaching the vessel interface to the vessel outer wall and directly attaching the skin interface to the dermal layer beneath the skin.
Stated Advantages
Promote fibrous tissue ingrowth.
Help prevent back-wall perforation and back bleeding.
Prevent rotation.
Limit undesired fluid leakage.
Documented Applications
Accessing a blood vessel.
Providing access to a blood vessel.
Dialysis needle access through the lumen.
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