Mechanical circulatory support system with insertion tool

Patent metadata

Field	Value
Publication number	US-2022161021-A1
Application number	US-202117530409-A
Country	US
Kind code	A1
Filing date	Nov 18, 2021
Priority date	Nov 20, 2020
Publication date	May 26, 2022
Grant date	—

Abstract

A minimally invasive miniaturized percutaneous mechanical circulatory support system for transcatheter delivery of a pump to the heart that actively unloads the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation. The pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor. The impeller may be rotated by the motor, via a shaft with an annular polymeric seal around the shaft, or via a magnetic drive. The system may have an insertion tool having a tubular body and configured to axially movably receive the circulatory support device, and an introducer sheath configured to axially movably receive the insertion tool.

First claim

What is claimed is:

1 . A mechanical circulatory support system, comprising:
a circulatory support catheter, comprising a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor; an insertion tool having a tubular body and configured to axially movably receive the circulatory support device; and an introducer sheath, having a tubular body and configured to axially movably receive the insertion tool.

2 . The system of claim 1 , wherein the impeller is configured to be rotated by the motor via a shaft.

3 . The system of claim 2 , wherein the circulatory support device comprises an annular polymeric seal around the shaft.

4 . The system of claim 2 , wherein the circulatory support device comprises a seal around the shaft, the seal comprising a distal radial shaft seal having a distal side configured to face distally toward the impeller and a radially inner lip configured to contact the shaft and to extend from the distal side in a proximal direction toward the motor.

5 . The system of claim 4 , further comprising a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a radially inner lip configured to contact the shaft and to extend from the proximal side in a distal direction toward the impeller.

6 . The system of claim 1 , wherein the impeller is configured to be rotated by the motor via a magnetic coupling.

7 . The system of claim 1 , wherein the introducer sheath comprises a hub on a proximal end of the introducer sheath, the hub having a feature for preventing axial and optionally rotational movement of the insertion tool.

8 . The system of claim 7 , the hub comprising one or more hemostatic valves.

9 . The system of claim 8 , wherein the tubular body of the insertion tool has sufficient collapse resistance to maintain patency when passed through the one or more hemostatic valves of the introducer sheath.

10 . The system of claim 7 , wherein the hub and a relief bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool.

11 . The system of claim 1 , wherein the insertion tool comprises a tube with a valve in fluid communication with an inner lumen of the tubular body of the insertion tool configured for flushing with saline.

12 . The system of claim 1 , the catheter shaft comprising a visual marker spaced proximally from the circulatory support device such that visibility of the visual marker on a proximal side of the introducer sheath indicates the circulatory support device is located within the tubular body of the insertion tool.

13 . The system of claim 1 , further comprising a first guidewire port on a distal end of the tubular housing of the circulatory support device, a second guidewire port on a sidewall of the tubular housing of the circulatory support device and distal to the impeller, and a third guidewire port on a proximal side of the impeller.

14 . The system of claim 13 , wherein a distal end of the tubular body of the insertion tool detachably connects to a guidewire aid configured to facilitate entry of a guidewire through the first guidewire port.

15 . The system of claim 13 , wherein a removable guidewire guide tube enters the first guidewire port on the distal end of the tubular housing, exits the tubular housing via the second guidewire port on the sidewall of the tubular housing distal to the impeller, reenters the tubular housing via the third guidewire port on the proximal side of the impeller, and extends proximally into the catheter shaft.

16 . The system of claim 15 , wherein the tubular body of the insertion tool is configured to receive the circulatory support device with the removable guidewire guide tube.

17 . The system of claim 16 , wherein the tubular body of the insertion tool and the guidewire guide tube are transparent.

18 . The system of claim 1 , wherein the tubular body of the insertion tool has a length within a range of from about 85 mm to about 160 mm and an inside diameter within a range of from about 4.5 mm to about 6.5 mm.

19 . The system of claim 1 , the tubular housing of the circulatory support device comprising an inlet tube coupled with a motor housing, the inlet tube having one or more distal pump inlets and one or more proximal pump outlets, and the impeller adjacent the one or more proximal pump outlets.

20 . The system of claim 1 , wherein the system does not require purging.

21 . The system of claim 1 , wherein the introducer sheath is a 16 French (Fr) sheath.

22 . The system of claim 1 , wherein the circulatory support device is configured to provide a flow rate of blood of about 4.0 liters per minute (l/min) for about 6 hours.

23 . The system of claim 1 , wherein the insertion tool comprises a hemostatic valve.

24 . The system of claim 1 , wherein the insertion tool comprises a plug disposed at a proximal end of the insertion tool configured to connect to a sterile shield sleeve.

25 . The system of claim 1 , wherein the insertion tool comprises a locking mechanism, the locking mechanism comprising a recess configured to accept a locking pad configured to releasably lock with the circulatory support catheter.

26 . The system of claim 25 , wherein the insertion tool comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced farther than opposing second inner surface walls, wherein the at least a portion of the locking mechanism comprises radially outwardly extending tabs, and wherein the housing is configured to rotate to inwardly compress the tabs to prevent axial movement of the circulatory support catheter.

27 . The system of claim 26 , wherein inward compression of the tabs of the locking mechanism compresses the locking pad against the circulatory support catheter.

28 . A mechanical circulatory support system, comprising:
an elongate flexible catheter shaft, having a proximal end and a distal end; a circulatory support device carried by the distal end of the catheter shaft, the circulatory support device comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor; wherein the circulatory support device is configured to provide a flow rate of blood of up to about 4.0 liters per minute (l/min) for about 6 hours without purging of the system.

29 . The system of claim 28 , wherein the impeller is configured to be rotated by the motor via a shaft.

30 . The system of claim 29 , wherein the circulatory support device comprises an annular polymeric seal around the shaft.

31 . The system of claim 29 , wherein the circulatory support device comprises a seal around the shaft, the seal comprising a distal radial shaft seal having a distal side configured to face distally toward the impeller and a radially inner lip configured to contact the shaft and to extend from the distal side in a proximal direction toward the motor.

32 . The system of claim 31 , further comprising a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a

Assignees

• Kardion Gmbh

Inventors

• Mitze Marvin
• Christof Hans
• Popov Vladimir
• Schwarz Martin
• Wenning Leon
• Bette Johannes
• Fabiunke Attila
• Görries Julian
• Schöfer Jan
• Rex Valentin
• Berner Johannes
• Ferch Johannes
• Luley Hans-Baldung
• Döhring Tom
• Burghaus Jens
• Schellenberg Inga
• Baumbach Hardy
• Bach Annika
• Stotz Ingo
• Kassel Julian
• Schuelke Armin
• Henneck Stefan
• Minzenmay David
• Schlebusch Thomas Alexander
• Schmid Tobias
• Pirk Tjalf
• Budde Martina
• Ehrenpfordt Ricardo
• Schmid Marc
• Mansour Ahmad
• Baeuerle Niko
• Wassermann Peter
• Eiberger Fabian
• Martin Kenneth M
• Friedrich Thomas
• Heintze Mario

Classifications

• A61M60/865

  Devices for guiding or inserting pumps or pumping devices into the patient's body · CPC title

• A61M60/812

  Vanes or blades, e.g. static flow guides · CPC title

• A61M60/419

  the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets · CPC title

• A61M60/221

  the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps · CPC title

• A61M60/827

  Sealings between moving parts · CPC title