IP Library › Granted Patent US 12,318,116
Granted Patent B2
US 12,318,116 · App. 16/641,724 · Granted Jun 3, 2025

Cardiac lead extraction device

Inventors: Benny Rousso (Rishon-LeZion, IL); Rodny Zarini (Moshav Pedaya, IL); David Maier Neustadter (Nof Ayalon, IL); Yonatan Levi (Tel Aviv, IL); Naama Winetraub (Holon, IL); Lior Eshel (Rishon-LeZion, IL); Assaf Erell (Ramat-Gan, IL)
Assignee: Xcardia Innovation Ltd
A61B17/3468A61B17/00234A61B17/32002A61B2017/00243A61B2017/003A61B2017/00358A61B2017/320032A61B2017/32004
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Quick Facts
Patent No.
US 12,318,116
App. No.
16/641,724
Granted
Jun 3, 2025
Kind
B2
Abstract

The invention relates to a cardiac lead extraction device, comprising: a handle; an elongated body having a first proximal end, a first distal end, and a first lumen extending from said first proximal end toward said first distal end, said lumen sized and shaped to fit over a cardiac lead; a controllable bendable flexible portion more flexible that said elongated body and having a second proximal end, a second distal end and a second lumen extending from said second proximal end toward said second distal end, said lumen sized and shaped to fit over a cardiac lead; said second proximal end interconnected to said first distal end; said second distal end interconnected to an operational distal end; wherein said operational distal end comprises at least one lead extraction assistive tool, said lead extraction helping tool is activated by a motor located at said handle or proximally to said handle.

Claims (45)

1. A cardiac lead extraction system, comprising:

a. a handle;

b. an elongated body in communication with said handle;

c. an external bendable flexible portion in communication with said elongated body, said external bendable flexible portion comprising a first lumen sized and shaped to fit over a cardiac lead; said external bendable flexible portion being more flexible than said elongated body;

d. an operational distal end in communication with said external bendable flexible portion;

wherein said external bendable flexible portion is configured to bend to a bending radius of less than 4 cm while keeping said first lumen open;

wherein said operational distal end comprises at least one lead extraction assistive tool, said operational distal end comprising a second lumen sized and shaped to fit over said cardiac lead, said second lumen being in communication with said first lumen, and said first lumen comprises an inner diameter of from about 1 mm to about 5 mm;

wherein said system comprises a pedal in communication with said handle, said pedal configured for activating said operational distal end; and

wherein said operational distal end comprises at least one impact mechanism positioned within said operational distal end, said at least one impact mechanism comprising at least one spring and at least one movable component; said at least one spring configured to provide momentum to said at least one movable component which performs an impact action once said at least one spring is released.

2. The system of claim 1 , wherein said system further comprises a controllable steering mechanism configured to orient said operational distal end.

3. The system of claim 2 , wherein said controllable steering mechanism comprises at least one wire that runs from said handle to said operational distal end, and wherein said at least one wire runs inside a counter sleeve on said elongated body.

4. The system of claim 1 , wherein said external bendable flexible portion is configured to bend to a minimum bending radius of from about 2 mm to about 15 mm.

5. The system of claim 1 , wherein said external bendable flexible portion comprises at least one articulated structure configured to maintain said first lumen open.

6. The system of claim 1 , wherein an outer diameter of said cardiac lead extraction system is from about 5 mm to about 8 mm.

7. The system of claim 1 , wherein said external bendable flexible portion bends to a maximal angle of from about 35 degrees to about 150 degrees.

8. The system of claim 7 , wherein an inner diameter of said external bendable flexible portion changes in length from about 0% to about 10% during said maximal angle.

9. The system of claim 7 , wherein one or more of the following is true:

a. said external bendable flexible portion is capable of bending to said maximal angle during active deflection of the system while withstanding forces up to 3000 gf;

b. said external bendable flexible portion is capable of bending to said maximal angle during passive deflection of the system while withstanding forces up to 500 gf.

10. The system of claim 1 , wherein said external bendable flexible portion is configured to perform a movement from 0 degrees to about 180 degrees.

11. The system of claim 1 , wherein:

a. said elongated body comprises a first proximal end, a first distal end, and a third lumen extending from said first proximal end toward said first distal end, said third lumen sized and shaped to fit over said cardiac lead; and

b. said external bendable flexible portion comprises a second proximal end, a second distal end and said first lumen extending from said second proximal end toward said second distal end, said second lumen sized and shaped to fit over said cardiac lead.

12. The system of claim 1 , further comprising a motor.

13. The system of claim 12 , wherein said motor is located at said handle.

14. The system of claim 12 , wherein said motor is located at said pedal.

15. The system of claim 1 , wherein said pedal is used to activate and control said at least one lead extraction assistive tool.

16. The system of claim 1 , wherein said handle is used to activate and control said at least one lead extraction assistive tool.

17. The system of claim 1 , wherein said at least one lead extraction assistive tool comprises one or more components configured to perform repeatable movement at a repetition rate of from about 1 Hz to about 100 Hz.

18. The system of claim 17 , wherein said repetition rate is from about 5 Hz to about 60 Hz.

19. The system of claim 1 , wherein said at least one lead extraction assistive tool comprises a tissue cutter.

20. The system of claim 19 , wherein said tissue cutter comprises at least one movable blade.

21. The system of claim 20 , wherein said tissue cutter comprises at least one transmission attached to a motor; said at least one transmission adapted to transfer motion from said motor to said at least one movable blade.

22. The system of claim 21 , wherein said motion of said at least one movable blade is linear.

23. The system of claim 21 , wherein said motion of said at least one movable blade is circular.

24. The system of claim 21 , wherein said motion of said at least one transmission is configured to provide said at least one movable blade with a linear motion comprising an impact force to apply on tissue.

25. The system of claim 21 , wherein said motion of said at least one movable blade is a combination of linear movement and circular movement.

26. The system of claim 21 , wherein said motion of said at least one movable blade is characterized by a frequency from about 0.5 Hz to about 100 Hz.

27. The system of claim 21 , wherein said motion of said at least one movable blade is characterized by a frequency from about 1 Hz to about 15 Hz.

28. The system of claim 21 , wherein said at least one movable blade comprises a retracted state where said at least one movable blade is not exposed thereby minimizing said at least one movable blade from damaging tissue.

29. The system of claim 21 , wherein said at least one movable blade exits distally said operational distal end from about 0.15 mm to about 2 mm.

30. The system of claim 19 , wherein said tissue cutter comprises at least two movable blades.

31. The system of claim 30 , wherein a relative movement of said at least two movable blades provides cutting by shearing.

32. The system of claim 1 , wherein said external bendable flexible portion comprises at least one internal structure configured to transmit motion from said handle to said operational distal end through said elongated body.

33. The system of claim 1 , wherein said lead extraction assistive tool comprises a lead cutter.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 1, 2024
From: MDSG INNOVATION LTD.
To: XCARDIA INNOVATION LTD
Reel/Frame 067879/0828 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 15, 2020
From: ROUSSO, BENNY; ZARINI, RODNY; NEUSTADTER, DAVID MAIER; LEVI, YONATAN; WINETRAUB, NAAMA; ESHEL, LIOR; ERELL, ASSAF
To: MDSG INNOVATION LTD.
Reel/Frame 052398/0067 →
Continuity (3)
Provisional Application 62668898 · May 9, 2018
Provisional Application 62549996 · Aug 25, 2017
Related Publication 20200352552A1 · Nov 12, 2020
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