Filler material, filler delivery device, and filler delivery method
Inventors
Yamanouchi, Dai • Yoshimori, Takashi
Assignees
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Publication Number
US-11317922-B2
Publication Date
2022-05-03
Expiration Date
Abstract
A filler delivery device is configured to place a filler inside a bulge occurring in a body lumen. The filler delivery device includes a frame member configured to be expandable and compressible, and a tubular member through which a catheter for injecting the filler into the bulge is insertable. The tubular member is provided such that, when the frame member is in an expanded state, an open end of the tubular member is directed in a direction intersecting an extending direction of the body lumen. The filler material includes a base gel having flowability with which the filler material flows inside the catheter, and shape retainability with which the filler material stays inside the bulge after being injected from the catheter into the bulge, and a solidification promoting substance that promotes solidification of blood inside the bulge.
Core Innovation
A filler delivery device is configured to place a filler inside a bulge occurring in a body lumen. The device includes a frame member configured to be expandable and compressible, and a tubular member through which a catheter for injecting the filler into the bulge is insertable. The frame member includes a plurality of main wire elements and a plurality of auxiliary wire elements connecting the main wire elements to each other, and a distal end of the tubular member is joined to an inside surface of the frame member with a joint place between one of the plurality of the main wire elements and the distal end of the tubular member.
When the frame member is in an expanded state, an open end of the tubular member is directed in a direction intersecting an extending direction of the body lumen. A distal end of the catheter is capable of being protruded from and drawn into the open end. This arrangement allows the catheter distal end to access the bulge from the open end while the expanded frame positions and supports the delivery structure.
The described filler includes a base gel with catheter injectability and post-injection retention, and further includes a solidification-promoting substance that promotes blood solidification, including thrombus, organization, and fibrosis. The filler may also include a visualization substance with low X-ray transmittance to reduce CT/MRI imaging artifacts versus metal coils, and the described system is contrasted with conventional materials such as metal coils, gelatin sponge, cyanoacrylate, and DMSO solution of EVOH.
Claims Coverage
The partial content identifies two independent claims: one for a filler delivery device and one for a filler delivery method. Across both independent claims, the coverage centers on an expandable/compressible frame with main and auxiliary wire elements, a tubular member joined to the frame inside surface via a defined joint place, and an expanded-state configuration where the tubular open end is oriented to intersect the body lumen extending direction to enable catheter protrusion and injection into a bulge.
Expandable and compressible frame with main and auxiliary wire elements
A filler delivery device comprising a frame member configured to be expandable and compressible, wherein the frame member includes a plurality of main wire elements and a plurality of auxiliary wire elements connecting the main wire elements to each other.
Tubular member joined to inside surface with joint place
A frame member in which a distal end of the tubular member is joined to an inside surface of the frame member, wherein the inside surface of the frame member includes a joint place between one of the plurality of the main wire elements and the distal end of the tubular member.
Intersecting-direction tubular open end enabling catheter protrusion and retraction
The tubular member being provided such that, when the frame member is in an expanded state, an open end of the tubular member is directed in a direction intersecting an extending direction of the body lumen, and a distal end of the catheter is capable of being protruded from and drawn into the open end.
Expanding to press inner surface of body lumen or tubular indwelling device
Expanding the frame member to cause the frame member to contact and press an inner surface of the body lumen or an inner surface of a tubular indwelling device placed in the body lumen.
Catheter movement through tubular member and injection from portion passed through open end
Moving the catheter toward the open end of the tubular member, the catheter being inserted through the tubular member of the filler delivery device; and injecting the filler into the bulge from a distal end portion of the catheter that has passed through the open end of the tubular member.
Across the independent device and method claims, the core claim coverage requires an expandable/compressible frame formed by main and auxiliary wire elements, a tubular member whose distal end is joined to the frame inside surface at a joint place, and an expanded-state orientation in which the tubular open end intersects the body lumen extending direction to permit catheter protrusion and retraction and catheter injection into the bulge, with the method further requiring expanded-state pressing against an inner surface and injection from the catheter portion that has passed through the open end.
Stated Advantages
Improved imaging compared with metal coils by using a visualization substance with low X-ray transmittance to reduce CT/MRI imaging artifacts.
Ease of handling and compatibility with catheters are stated as advantages versus conventional materials.
Documented Applications
Occluding a blood-vessel bulge, including an aneurysm, by injecting a tailored filler through a catheter delivered by the expandable/compressible frame and tubular member.
Placement concept with or without a pre-placed stent graft, including positioning the frame and injecting filler to fill and occlude the bulge while suppressing endoleak.
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