Devices and methods for treating edema

Patent metadata

Field	Value
Publication number	US-2023364412-A1
Application number	US-202318213573-A
Country	US
Kind code	A1
Filing date	Jun 23, 2023
Priority date	Feb 26, 2019
Publication date	Nov 16, 2023
Grant date	—

Abstract

The disclosure relates to devices and methods for the treatment of edema using a purge-free system. The invention provides devices and methods useful for treating edema by means of an indwelling catheter that is placed in a blood vessel of a patient and used to pump blood to cause a decrease in pressure at an outlet of a lymphatic duct. The catheter pumps blood by means of an impeller but is purge-free in that the catheter does not include a system for purging or flushing catheter components with a purge fluid. The purge-free catheter avoids blood-related mechanical complications such as clotting or thrombosis by means of an impermeable sleeve or shroud that protects moving parts of the impeller drive system.

First claim

1 .- 21 . (canceled)

22 . A device comprising:
an indwelling catheter comprising a proximal portion and a distal portion; an impeller assembly mounted at the distal portion of the catheter, the impeller assembly comprising an impeller housing with an impeller disposed therein, and a cuff comprising a distal surface and a proximal surface wherein a proximal end of a core diameter of the impeller rotates in clearance of the distal surface of the cuff; a motor connected to the proximal portion of the catheter; a drive cable extending through the catheter from the motor to the impeller; and an impermeable sleeve extending through the catheter over the drive cable, the sleeve comprising a distal seal at the impeller and a proximal seal at the motor such that a body fluid external to the impermeable sleeve is prevented from entering the impermeable sleeve and contacting the drive cable.

23 . The device of claim 22 , wherein a clearance between the cuff distal surface and the impeller defines a proximal gap.

24 . The device of claim 23 , wherein the proximal gap is configured to define a transition between a static core of the impeller assembly to a rotating core of the impeller.

25 . The device of claim 23 , wherein the proximal gap is configured to remain fixed during operation of the device.

26 . The device of claim 23 , wherein the proximal gap is configured to allow blood to flow across the proximal gap without flow disturbance, flow recirculation, or vortices.

27 . The device of claim 22 , wherein the proximal surface of the cuff comprises a guide surface, and one or more struts extending from the proximal surface of the cuff to the impeller housing.

28 . The device of claim 27 , wherein the impeller assembly further comprises a proximal inlet region and a distal outlet region, wherein the guide surface tapers toward the impeller to change a cross sectional area along a length at the inlet region.

29 . The device of claim 28 , wherein the guide surface, the struts, and the impeller housing define the inlet region such that fluid divergence in the inlet region is minimized.

30 . The device of claim 28 , wherein the guide surface comprises one or more of a curved tapered section, a cylindrical region, and a substantially conical region.

31 . The device of claim 29 , wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlet region and out of the impeller assembly via the outlet region such that flow into the inlet region and into the impeller assembly is achieved without recirculation or vortices.

32 . The device of claim 28 , further comprising an expandable member connected directly to an outer surface of the impeller housing, wherein the expandable member comprises a collapsed configuration and an expanded configuration.

33 . The device of claim 32 , wherein the expandable member is positioned between the proximal inlet region and the distal outlet region.

34 . The device of claim 33 , wherein, when in an expanded configuration, an axial length of the expandable member extends beyond the impeller housing.

35 . The device of claim 32 , wherein the expandable member comprises a toroidal balloon, wherein, when in an expanded configuration, the toroidal balloon surrounds the impeller housing.

36 . The device of claim 23 , wherein the proximal gap is in fluid communication with a catheter lumen.

37 . The device of claim 36 , wherein the fluid lumen is in fluid communication with a fluid reservoir exterior of a patient.

38 . The device of claim 37 , wherein the proximal gap is configured to provide resistive fluid pressure to prevent blood from entering the proximal gap.

39 . The device of claim 37 , wherein the fluid is a purge fluid to flush blood from the proximal gap.

40 . The device of claim 22 , wherein the proximal seal comprises a fitting between the impermeable sleeve and a portion of the impeller, wherein the fitting excludes fluids and allows the impeller and drive cable to rotate within the device.

41 . The device of claim 22 , wherein the distal portion of the catheter is configured for insertion into a vessel of a patient and the proximal portion of the catheter is configured to extend exterior of the patient.

Assignees

• White Swell Medical Ltd

Inventors

• Nitzan Yaacov
• Keating Ronan
• Marmur Shahaf
• Inbar Or
• Brady Eamon
• Mccaffrey Gerry
• Williston Reed
• Raz Sagi

Classifications

• A61M60/414 Primary

  transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter · CPC title

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61M25/10

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title

• A61M2205/0216

  Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking · CPC title

• A61M2205/3331

  Pressure; Flow · CPC title