IP Library Granted Patent US 11,786,300
Granted Patent B2
US 11,786,300 · App. 17/931,975 · Granted Oct 17, 2023

Pulsed field ablation device and method

Inventors: Vojt{hacek over (e)}ch Nedv{hacek over (e)}d (Mariánské Lázn{hacek over (e)}, CZ); Ji{hacek over (r)}í Da{hacek over (s)}ek (Sop{hacek over (r)}e{hacek over (c)}— Vápno u P{hacek over (r)}elou{hacek over (, CZ); Martin Hanuliak (Prague, CZ); Ahmad Hijazi (Prague, CZ)
Assignee: BTL Medical Technologies s.r.o.
A61B18/1492A61B18/1206A61B2018/00083A61B2018/00267A61B2018/00577A61B2018/126
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Quick Facts
Patent No.
US 11,786,300
App. No.
17/931,975
Granted
Oct 17, 2023
Kind
B2
Abstract

An ablation device and method for pulsed field ablation, the device comprising a catheter including an expandable basket, a set of electrodes formed on the expandable basket, and a pulse generator suitable for generating electric pulses wherein the pulse generator being in electrical connection with the set of electrodes. The expandable basket is formed of a braided mesh of filaments, wherein the filaments are made of nonconductive material, wherein at least portion of the filaments comprises a lumen, wherein the filaments further include electrodes and conductive wires. The conductive wires at least partially lead inside of the lumen of the filaments and are electrically connected to the electrodes.

Claims (55)

1. An ablation device for pulsed field ablation of a tissue by pulsed electric field, the device comprising:

a catheter configured for insertion into a heart of a patient, the catheter including an expandable basket comprising a plurality of filaments braided into a braided mesh, wherein the expandable basket is configured to be manipulated from a collapsed configuration to at least one expanded configuration, the filaments comprising an electrically non-conductive material;

a set of electrodes positioned on the expandable basket,

a pulse generator configured to generate electric pulses, the pulse generator electrically coupled to the set of electrodes via at least one wire, the wire being at least partially positioned within at least one filament of the plurality of filaments;

wherein distances between electrodes included in the set of electrodes in a fully expanded configuration of the expandable basket are in a range from 0.1 mm to 15 mm;

wherein the set of electrodes is configured to provide pulsed electric fields from the electric pulses causing ablation of a tissue within the heart of the patient; and

wherein the set of electrodes comprises a first electrode configured for operation in a mode of a first polarity, a second electrode configured for operation in a mode of a second polarity different than the first polarity, and a third electrode configured for operation in a mode of a state of impedance higher than 500Ω.

2. The ablation device according to claim 1 , wherein a ratio of a surface area of the first electrode to a surface area of the second electrode is in a range from 2:3 to 1:100.

3. The ablation device according to claim 1 , wherein the set of electrodes comprises at least one electrode configured to be switched between at least two of the modes during an ablation.

4. The ablation device according to claim 1 , wherein the set of electrodes comprises at least two second electrodes configured for operation in the mode of the second polarity different than the first polarity.

5. The ablation device according to claim 4 , wherein the set of electrodes comprises at least two third electrodes configured for operation in the mode of the state of impedance higher than 500Ω.

6. The ablation device according to claim 4 , wherein a ratio of a surface area or sum of the surface areas of the at least one first electrode to a sum of a surface areas of the at least two second electrodes is in a range from 2:3 to 1:100.

7. The ablation device according to claim 1 , wherein the third electrode is spatially adjacent to the first electrode.

8. An ablation device for pulsed field ablation of a tissue by pulsed electric field, the device comprising:

a catheter configured for insertion into a heart of a patient, the catheter including an expandable basket comprising a plurality of filaments braided into a braided mesh, the filaments comprising an electrically non-conductive material;

a set of electrodes positioned on the expandable basket;

a pulse generator configured to generate electric pulses, the pulse generator electrically coupled to the set of electrodes via at least one wire, the wire being at least partially positioned within at least one filament of the plurality of filaments;

wherein the set of electrodes is configured to provide pulsed electric fields from the electric pulses causing ablation of a tissue within the heart of the patient;

wherein the set of electrodes comprises a first electrode configured for operation in a mode of a first polarity, a second electrode configured for operation in a mode of a second polarity different than the first polarity, and a third electrode configured for operation in a mode of a state of high impedance; and

wherein the set of electrodes comprises at least one electrode configured to be switched between at least two of the modes during an ablation.

9. The ablation device according to claim 8 , wherein the third electrode is configured for operation in a mode of a state of impedance higher than 500Ω.

10. The ablation device according to claim 8 , wherein a ratio of a surface area of the first electrode to a surface area of the second electrode is in a range from 2:3 to 1:100.

11. The ablation device according to claim 8 , wherein the set of electrodes comprises at least two second electrodes configured for operation in the mode of the second polarity different than the first polarity.

12. The ablation device according to claim 11 , wherein the set of electrodes comprises at least two third electrodes configured for operation in the mode of the state of high impedance.

13. The ablation device according to claim 11 , wherein a ratio of a surface area or sum of the surface areas of the at least one first electrode to a sum of a surface areas of the at least two second electrodes is in a range from 2:3 to 1:100.

14. The ablation device according to claim 8 , wherein the third electrode is spatially adjacent to the first electrode.

15. An ablation device for pulsed field ablation of a tissue by pulsed electric field, the device comprising:

a catheter configured for insertion into a heart of a patient, the catheter including an expandable basket comprising a plurality of filaments braided into a braided mesh, the filaments comprising an electrically non-conductive material and a lumen;

a set of electrodes positioned on the expandable basket;

a pulse generator configured to generate electric pulses, the pulse generator electrically coupled to the set of electrodes via at least one wire, the wire being at least partially positioned within the lumen of the at least one filament of the plurality of filaments;

wherein the at least one filament is reinforced by a reinforcement strut positioned in the lumen of the at least one filament of the plurality of filaments;

wherein the set of electrodes is configured to provide pulsed electric fields from the electric pulses causing ablation of a tissue within the heart of the patient;

wherein the set of electrodes comprises a first electrode configured for operation in a mode of first polarity, a second electrode configured for operation in a mode of a second polarity different than the first polarity, and a third electrode configured for operation in a mode of a state of high impedance; and

wherein a ratio of a surface area of the first electrode to a surface area of the second electrode is in a range from 2:3 to 1:100.

16. The ablation device according to claim 15 , wherein the third electrode is configured for operation in a mode of a state of impedance higher than 500Ω.

17. The ablation device according to claim 15 , wherein the set of electrodes comprises at least one electrode configured to be switched between at least two of the modes during an ablation.

18. The ablation device according to claim 15 , wherein the set of electrodes comprises at least two second electrodes configured for operation in the mode of the second polarity different than the first polarity.

19. The ablation device according to claim 18 , wherein the set of electrodes comprises at least two third electrodes configured for operation in the mode of the state of high impedance.

20. The ablation device according to claim 18 , wherein a ratio of a surface area or sum of the surface areas of the at least one first electrode to a sum of a surface areas of the at least two second electrodes is in a range from 2:3 to 1:100.

21. The ablation device according to claim 15 , wherein the third electrode is spatially adjacent to the first electrode.

22. The ablation device according to claim 15 , wherein at least one filament of the plurality of filaments includes the wire and the reinforcement strut positioned in the lumen and wherein the reinforcement strut is made of electrically non-conductive material or includes an insulation layer, the wire includes an insulation layer and wherein the reinforcement strut and the wire are electrically insulated from each other.

23. An ablation device for pulsed field ablation of a tissue by pulsed electric field, the device comprising:

a catheter configured for insertion into a heart of a patient, the catheter including an expandable basket comprising a plurality of filaments braided into a braided mesh, the filaments comprising an electrically non-conductive material;

a set of electrodes positioned on the expandable basket;

a pulse generator configured to generate electric pulses, the pulse generator electrically coupled to the set of electrodes via at least one wire, the wire being at least partially positioned within at least one filament of the plurality of filaments;

wherein the set of electrodes is configured to provide pulsed electric fields from the electric pulses causing ablation of a tissue within the heart of the patient;

wherein a magnitude of the pulsed electric field is in a range from 0.1 kV/cm to 10 kV/cm; and

wherein the set of electrodes comprises a first electrode configured for operation in a mode with first polarity, a second electrode configured for operation in a mode with a second polarity different than the first polarity, and a third electrode configured for operation in a mode of a state of high impedance.

24. The ablation device according to claim 23 , wherein the third electrode is configured for operation in a mode of a state of impedance higher than 500Ω.

25. The ablation device according to claim 23 , wherein a ratio of a surface area of the first electrode to a surface area of the second electrode is in a range from 2:3 to 1:100.

26. The ablation device according to claim 23 , wherein the set of electrodes comprises at least one electrode configured to be switched between at least two of the modes during an ablation.

27. The ablation device according to claim 23 , wherein the set of electrodes comprises at least two second electrodes configured for operation in the mode of the second polarity different than the first polarity.

28. The ablation device according to claim 27 , wherein the set of electrodes comprises at least two third electrodes configured for operation in a mode of a state of high impedance.

29. The ablation device according to claim 27 , wherein a ratio of a surface area or sum of the surface areas of the at least one first electrode to a sum of a surface areas of the at least two second electrodes is in a range from 2:3 to 1:100.

30. The ablation device according to claim 23 , wherein the third electrode is spatially adjacent to the first electrode.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2023
From: NEDVED, VOJTECH; DASEK, JIRI; HANULIAK, MARTIN; HIJAZI, AHMAD
To: BTL MEDICAL TECHNOLOGIES S.R.O.
Reel/Frame 065353/0438 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 26, 2023
From: BTL MEDICAL TECHNOLOGIES S.R.O.
To: BTL MEDICAL DEVELOPMENT A.S.
Reel/Frame 065354/0134 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 13, 2023
From: NEDVED, VOJTECH; DASEK, JIRI; HANULIAK, MARTIN; HIJAZI, AHMAD
To: BTL MEDICAL TECHNOLOGIES S.R.O.
Reel/Frame 062669/0969 →
Continuity (5)
Continuation PCTIB2022000189 · Apr 6, 2022
Provisional Application 63249965 · Sep 29, 2021
Provisional Application 63218563 · Jul 6, 2021
Provisional Application 63171832 · Apr 7, 2021
Related Publication 20230000550A1 · Jan 5, 2023