IP Library Granted Patent US 10,667,753
Granted Patent B2
US 10,667,753 · App. 16/012,051 · Granted Jun 2, 2020

Catheter system and methods of medical uses of same, including diagnostic and treatment uses for the heart

Inventors: Randell L. Werneth (Eagle, ID); Graydon E. Beatty (Carlsbad, CA); Timothy J. Corvi (Carlsbad, CA); J. Christopher Flaherty (Auburndale, FL); Marcus Frederick Julian (Vista, CA)
Assignee: ACUTUS MEDICAL, INC.
A61B5/6858A61B5/0205A61B5/042A61B5/0422A61B5/4836A61B5/6852A61B8/12A61B8/445A61B8/4494A61B18/1492A61B5/046A61B5/0464A61B5/0538A61B5/065A61B5/6859A61B17/22012A61B18/02A61B18/1815A61B18/20A61B2017/00318A61B2018/0016A61B2018/00267A61B2018/00351A61B2018/00577A61B2018/00648A61B2018/00839A61B2018/00982A61B2018/1465A61B2018/1467A61B2018/1475A61B2034/301A61B2562/06A61N1/056
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Quick Facts
Patent No.
US 10,667,753
App. No.
16/012,051
Granted
Jun 2, 2020
Kind
B2
Abstract

The present invention includes systems, devices and methods for treating and/or diagnosing a heart arrhythmia, such as atrial fibrillation. Specifically, the present invention provides a system including a diagnostic catheter and an ablation catheter. The diagnostic catheter includes a shaft, multiple dipole mapping electrodes and multiple ultrasound transducers. The ablation catheter is slidingly received by the diagnostic catheter shaft.

Claims (48)

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 emit electric signals and receive electric signals; and

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

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

a processing unit configured to:

measure spacing between two or more of the electrodes based on the received electric signals and to determine a geometric configuration of one or more of the multiple splines based on the measured electrode spacing; and

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,

wherein at least one of:

the electrical information is further based on the determined geometric configuration of the one or more of the multiple splines, and/or

the anatomical geometry data is based on the determined geometric configuration of the one or more of the multiple splines.

2. The catheter system according to claim 1 , wherein:

the electrical information is based on the received electric signals and the determined geometric configuration of the one or more of the multiple splines, and

the anatomical geometry data is based on the determined geometric configuration of the one or more of the multiple splines.

3. The catheter system according to claim 1 , wherein the processing unit is further configured to determine a geometric configuration of the multiple splines based on the measured electrode spacing.

4. 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.

5. The catheter system according to claim 1 , wherein the processing unit is further configured to derive a shape of one or more of the multiple splines.

6. The catheter system according to claim 5 , wherein the processing unit is further configured to derive the shape of the one or more of the multiple splines in real time.

7. The catheter system according to claim 1 , wherein the processing unit is further configured to derive a relative positioning of two or more of the multiple splines.

8. The catheter system according to claim 7 , wherein the processing unit is further configured to derive the relative positioning of the two or more of the multiple splines in real time.

9. The catheter system according to claim 1 , wherein the multiple splines are resiliently biased in an equilibrium state, and wherein the processing unit is further configured to determine a change in a shape of the multiple splines from the equilibrium state.

10. The catheter system according to claim 9 , wherein the change in shape comprises a change in the shape of a single spline.

11. The catheter system according to claim 9 , wherein the multiple splines comprise a first spline and a second spline, and wherein the change in shape comprises a change in the position of the first spline relative to the second spline.

12. The catheter system according to claim 9 , wherein:

the plurality of electrodes comprises a first electrode and a second electrode,

the change in shape comprises a bowing of a first spline,

the first electrode and the second electrode are attached to the first spline, and

the bowing causes the spacing between the first electrode and the second electrode to decrease.

13. The catheter system according to claim 9 , wherein:

the plurality of electrodes comprises a first electrode and a second electrode,

the change in shape comprises a straightening of a first spline, wherein the first electrode and the second electrode are attached to the first spline, and

the straightening causes the spacing between the first electrode and the second electrode to increase.

14. The catheter system according to claim 1 , wherein:

the plurality of electrodes comprises a first electrode and a second electrode, and

the system further comprises a current source that applies a current between the first electrode and the second electrode to determine the spacing between the first electrode and the second electrode.

15. The catheter system according to claim 1 , further comprising an ablation catheter comprising:

an elongate shaft with a distal portion; and

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

wherein the elongate shaft of the diagnostic catheter further comprises a lumen and the ablation catheter is at least partially within the lumen.

16. The catheter system according to claim 15 , wherein the at least one ablation element comprises an ablation element selected from the group consisting of: an electrode; a vessel configured to deliver cryogenic energy; a laser diode; an optical fiber configured to deliver ablative energy; a microwave energy delivery element; an ultrasound energy delivery element; a drug or other agent delivery element; and combinations thereof.

17. 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.

18. 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 Hertz.

19. 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.

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

21. 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.

22. 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)
RELEASE OF SECURITY INTEREST Recorded Jun 3, 2026
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: ACUTUS MEDICAL, INC.
Reel/Frame 075681/0812 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2025
From: ACUTUS MEDICAL, INC.
To: ENCHANNEL MEDICAL, LTD.
Reel/Frame 071698/0777 →
SECURITY INTEREST Recorded May 21, 2019
From: ACUTUS MEDICAL, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINSTRATIVE AGENT
Reel/Frame 049245/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2018
From: WERNETH, RANDELL L.; BEATTY, GRAYDON E.; CORVI, TIMOTHY J.; FLAHERTY, J. CHRISTOPHER; JULIAN, MARCUS FREDERICK
To: ACUTUS MEDICAL INC.
Reel/Frame 046460/0890 →
Continuity (3)
Continuation 14422941
Provisional Application 61695535 · Aug 31, 2012
Related Publication 20190021673A1 · Jan 24, 2019
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