Granted Patent B2

US 12,318,225 · App. 16/861,814 · Granted Jun 3, 2025

Inventors: Randell L. Werneth (Rancho Santa Fe, CA); Graydon E. Beatty (Carlsbad, CA); Timothy J. Corvi (Carlsbad, CA); J. Christopher Flaherty (Auburndale, FL); Marcus Frederick Julian (Vista, CA)

Assignee: ACUTUS MEDICAL, INC.

A61B5/6858A61B5/0036A61B5/0205A61B5/283A61B5/287A61B5/6852A61B8/12A61B8/445A61B8/4494A61B18/1492A61B5/0538A61B5/065A61B5/361A61B5/363A61B5/6859A61B2017/00318A61B17/22012A61B2018/0016A61B2018/00267A61B2018/00351A61B2018/00577A61B2018/00648A61B2018/00839A61B2018/00982A61B18/02A61B2018/1465A61B2018/1467A61B2018/1475A61B18/1815A61B18/20A61B2034/301A61B2562/06A61N1/056

Abstract

Claims (32)

1. A catheter system comprising:

a diagnostic catheter comprising:

an elongate shaft comprising a distal end;

an expandable assembly mounted to the elongate shaft, the expandable assembly comprising multiple splines and configured to transition from a compacted state to an expanded state;

a plurality of electrodes coupled to the multiple splines of the expandable assembly, each electrode configured to receive electrical signals; and

a plurality of ultrasound transducers coupled to the multiple splines of the expandable assembly;

an ablation catheter comprising:

an elongate shaft comprising a distal portion;

at least one ablation element positioned on the ablation catheter shaft distal portion and configured to deliver energy to tissue; and

a steerable portion configured to be robotically manipulated;

a distance measurement assembly configured to drive the plurality of ultrasound transducers to produce anatomical geometry data, and to generate data representing a distance between each ultrasound transducer of the plurality of ultrasound transducers and a tissue surface orthogonal to each ultrasound transducer;

a processing unit configured to create a three-dimensional anatomical map based on the produced anatomical geometry data, create electrical information based on the received electric signals, and display the electrical information in relation to the three-dimensional anatomical map; and

a robotic assembly configured to manipulate the steerable portion of the ablation catheter based on the anatomical geometry data produced by the distance measurement assembly.

2. The catheter system according to claim 1 , wherein the ablation element comprises at least one electrode.

3. The catheter system according to claim 2 , wherein the processing unit is configured to determine the position of the at least one electrode of the ablation catheter relative to the plurality of electrodes of the diagnostic catheter.

4. The catheter system according to claim 3 , wherein the robotic assembly is configured to manipulate the steerable portion of the ablation catheter, and wherein the robotic assembly performs the manipulation based on the position of the at least one electrode of the ablation catheter relative to the plurality of electrodes of the diagnostic catheter.

5. The catheter system according to claim 4 , wherein the processing unit is configured to determine the position of the at least one electrode of the ablation catheter and the robotic assembly is configured to perform the manipulation of the steerable portion of the ablation catheter using a feedback loop.

6. The catheter system according to claim 1 , wherein the robotic assembly is configured to manipulate the steerable portion of the ablation catheter, and wherein the manipulation positions the at least one ablation element proximate target tissue to be ablated.

7. The catheter system according to claim 1 , wherein the diagnostic catheter further comprises a steerable portion configured to be robotically manipulated and wherein the steerable portion of the diagnostic catheter is further configured to be manually and/or semi-automatically manipulated.

8. The catheter system according to claim 1 , wherein the steerable portion of the ablation catheter is further configured to be manually and/or semi-automatically manipulated.

9. The catheter system according to claim 1 , wherein the diagnostic catheter further comprises a steerable portion configured to be robotically manipulated and wherein the robotic assembly is further configured to perform the manipulation of the steerable portion of the diagnostic catheter and/or the ablation catheter based on clinician input.

10. The catheter system according to claim 1 , wherein the diagnostic catheter further comprises a steerable portion configured to be robotically manipulated and wherein the robotic assembly is further configured to perform the manipulation of the steerable portion of the diagnostic catheter and/or the ablation catheter based on the electrical information created by the processing unit.

11. The catheter system according to claim 10 , wherein the electrical information comprises dipole mapping information.

12. The catheter system according to claim 1 , wherein the diagnostic catheter further comprises a steerable portion configured to be robotically manipulated and wherein the robotic assembly is configured to manipulate the steerable portions of both the diagnostic catheter and the ablation catheter.

13. The catheter system according to claim 1 , wherein the electrical information displayed comprises information selected from the group consisting of: cardiac or other tissue voltage measurements; cardiac or other tissue bipolar and/or unipolar electrograms; cardiac or other tissue surface charge data; cardiac or other tissue dipole density data; cardiac or other tissue monophasic action potentials;

and combinations thereof.

14. The catheter system according to claim 1 , further comprising a sheath with a distal end, and wherein the expandable assembly is configured to radially expand as it exits the sheath distal end.

15. The catheter system according to claim 1 , wherein the plurality of electrodes comprises at least one electrode with an impedance of less than 10,000 ohms for frequencies above 0.1 Hz.

16. The catheter system according to claim 1 , wherein the plurality of ultrasound transducers comprises an assembly selected from the group consisting of: single or multi-element piezoelectric ceramics; piezoelectric micro-machined ultrasound transducers (pMUT); capacitive micro-machined ultrasound transducers (cMUT); piezoelectric polymers; and combinations thereof.

17. The catheter system according to claim 1 , wherein each of the plurality of ultrasound transducers is disposed between two electrodes.

18. The catheter system according to claim 1 , further comprising at least one body surface electrode, wherein the distance measurement assembly is further configured to deliver a signal to the at least one body surface electrode, record a second generated signal from the at least one body surface electrode, and produce a second set of distance information based on the recording of the second generated signal.

19. The catheter system according to claim 1 , wherein the three-dimensional anatomical map includes at least one of heart wall position information or heart wall thickness information.

Assignments (4)

Continuity (4)

References Cited (400)