Non-thrombogenic devices for treating edema

Patent metadata

Field	Value
Publication number	US-12458359-B2
Application number	US-202117341848-A
Country	US
Kind code	B2
Filing date	Jun 8, 2021
Priority date	Jun 8, 2020
Publication date	Nov 4, 2025
Grant date	Nov 4, 2025

Abstract

The invention provides intravascular devices for treating certain medical conditions such as edema without causing thrombosis. The intravascular devices of the disclosure include non-thrombogenic surfaces that improve blood compatibility by reducing device-related thrombus formation and inflammatory reactions. The non-thrombogenic surfaces may include surface topographies (e.g., surface roughness) and modified chemistries (e.g., coatings and/or treatments), which prevent thrombosis by reducing local shear forces and inhibiting adhesion of blood clotting factors.

First claim

What is claimed is:

1 . An intravascular device, the device comprising:
a catheter dimensioned for insertion into a vein, the catheter comprising a proximal portion and a distal portion; and a cage attached to the distal portion of the catheter, the cage housing an impeller rotatably disposed therein, wherein at least a portion of the cage and/or the impeller comprises an interface disposed between a metal substrate of the cage and/or impeller and contact with blood within the vein, the interface comprising at least a surface layer comprising one or more of an oxide coating extending over the metal substrate and a hydrophilic surface coating, wherein the surface layer is configured to allow water molecules present in blood to outcompete one or more blood proteins associated with thrombus for adhesion with the interface when the catheter is inserted into the vein so that, when in contact with blood, the surface layer minimizes or prevents formation of blood clots.

2 . The device of claim 1 , wherein the hydrophilic surface coating comprises a surface film comprising a plurality of hydrophilic groups.

3 . The device of claim 1 , wherein binding between the water molecules present in blood and the surface layer displaces blood proteins associated with thrombus from the surface layer.

4 . The device of claim 1 , wherein the cage and/or the impeller comprises a metal, wherein and the surface layer of the interface of the cage and/or the impeller comprises a modification to an oxide layer of the metal.

5 . The device of claim 4 , wherein the metal comprises a transition metal, wherein the transition metal comprises at least one of scandium, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, or zinc, and the oxide layer comprises an oxide of the transition metal which comprises at least one of scandium, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, or zinc.

6 . The device of claim 1 , wherein the surface layer further comprises an enriched concentration of titanium or chromium.

7 . The device of claim 1 , wherein the surface layer further comprises a surface roughness, wherein the hydrophilic surface coating comprises a coating thickness greater than the surface roughness of the surface layer, wherein the surface roughness is measured by one or more of an average depth of roughness (Rz) of the surface layer of the cage and/or the impeller and an arithmetic average roughness (Ra) of the surface layer of the cage and/or the impeller.

8 . The device of claim 1 , wherein the hydrophilic surface coating comprises at least one of a polysaccharide, a polymer, or a hydrogel.

9 . The device of claim 8 , wherein the polysaccharide comprises heparin.

10 . The device of claim 8 , wherein the hydrophilic surface coating comprises one or more polymer chains comprising a hydrophilic end and a binding end, wherein the binding end is formulated to bond to the interface.

11 . The device of claim 10 , wherein the binding end is formulated as one or more of hydrophobic, formulated to establish strong van der Waals attractive forces with the interface, and formulated to establish strong polar attractive forces with the interface.

12 . The device of claim 1 , wherein the oxide coating comprises an altered oxide layer.

13 . The device of claim 12 , wherein the altered oxide layer is configured, via one or more of electropolishing, heat treatment, or acid passivation, to modify, remove, and/or exclude one or more oxides from the surface layer.

14 . The device of claim 1 , wherein the cage comprises the interface.

15 . The device of claim 1 , wherein substantially all of the cage and/or the impeller that is exposed to blood when the catheter is operating inside the vein comprises the interface.

16 . The device of claim 1 , wherein a distal portion of a shaft of the impeller and a distal portion of the cage defines a gap.

17 . The device of claim 16 , wherein at least one of the distal portion of the shaft or the distal portion of the cage defining the gap comprises the surface layer.

18 . The device of claim 1 , wherein the oxide coating comprises a modification to an oxide layer and the thickness of the modification to the oxide layer is less than 5,000 picometers.

19 . The device of claim 1 , wherein the one or more blood proteins displaced from the interface comprise one or more of fibrinogen, von Willebrand factor, albumin, and globulin.

20 . The device of claim 1 , wherein the impeller rotates in clearance with an inner lumen of the cage so that a blade clearance is from 7 to 110 micrometers inclusive.

21 . The device of claim 20 , wherein the hydrophilic surface coating comprises a polymer layer with a thickness of less than 5000 nanometers.

22 . The device of claim 21 , wherein the thickness of the polymer layer is reduced relative to gaps between the rotating impeller and the cage such that mechanical interference in the gaps is minimized.

Assignees

• White Swell Medical Ltd

Inventors

• Keating Ronan
• Brady Eamon
• Mccaffrey Gerry
• Raz Sagi
• Inbar Or
• Cannon Ann Marie

Classifications

• A61B17/12136

  Balloons · CPC title

• A61B2017/00942

  hydrophilic · CPC title

• A61B2017/0084

  low friction (A61B2017/00853 takes precedence) · CPC title

• A61B2017/00836

  corrosion-resistant (A61B2017/00853 takes precedence; preventing galvanic or electrolytic corrosion in prostheses A61F2210/0009) · CPC title

• A61M2205/0238

  the material being a coating or protective layer · CPC title