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US-20260123984-A1 - TISSUE MAPPING AND TREATMENT

US20260123984A1US 20260123984 A1US20260123984 A1US 20260123984A1US-20260123984-A1

Abstract

Methods, systems, and devices are described for mapping and treating tissue during a medical procedure. In some cases, a device includes a mesh of wires with sensors coupled thereto. The mapping device can be coupled to an expandable treatment element. Alternatively, the treatment device can be a separate device, and advanced through an access lumen in the mapping device. The expandable treatment element can include multiple segments. The sensors can be used to map a tissue area and monitor the tissue during a medical procedure

Inventors

  • Brian Schuler
  • David Bernstein
  • Philip J. Simpson
  • David G. Matsuura

Assignees

  • BIOZONAL ID, LLC

Dates

Publication Date
20260507
Application Date
20250513

Claims (20)

  1. 1 .- 37 . (canceled)
  2. 38 . A system for applying and monitoring ablation for treatment of atrial fibrillation, the system comprising: a diagnostic mapping mesh; one or more hardware processors configured to: receive a plurality of electrical signals from the diagnostic mapping mesh, the plurality of electrical signals indicative of ablation of a target tissue site; determine a control parameter based at least in part on (a) a threshold energy (“E1”) to stimulate a protected tissue, (b) a first time (“T1”) corresponding to detected ablation based on the received plurality of electrical signals, and (c) a treatment time (“Tt”) corresponding to an amount of time for application of ablation, the treatment time being a function of a ratio of the threshold energy over a predetermined constant threshold (“E2”) corresponding to a safe distance from the protected tissue; and adjust treatment based on the control parameter.
  3. 39 . The system of claim 38 , comprising a treatment device, and wherein the one or more hardware processors is configured to control the treatment device.
  4. 40 . The system of claim 39 , the treatment device comprising an ablation device.
  5. 41 . The system of claim 40 , the ablation device comprising a cryoablation device.
  6. 42 . The system of claim 40 , the ablation device comprising electrodes capable of transmitting electroporation energy.
  7. 43 . The system of claim 38 , wherein one or more processors is configured to determine the threshold energy E1.
  8. 44 . The system of claim 38 , wherein the one or more hardware processors are configured to predict treatment success based on a first time corresponding to an indication of ablation in the received plurality of electrical signals or a spatial pattern of a change in the received plurality of electrical signals.
  9. 45 . The system of claim 38 , wherein the system is configured to adjust treatment based on the control parameter comprises adjustment of a cryoablation fluid flow.
  10. 46 . The system of claim 38 , wherein the system is configured to adjust treatment based on the control parameter comprises adjustment of an electroablation energy.
  11. 47 . The system of claim 38 , wherein the system is configured to additionally administer further ablation treatment following adjusting treatment.
  12. 48 . The system of claim 47 , wherein the further ablation treatment comprises further administration of cryoablation of an adjusted cryoablation fluid flow.
  13. 49 . The system of claim 47 , wherein the further ablation treatment comprises further administration of adjusted electroablation energy.
  14. 50 . A method for applying and monitoring ablation for treatment of atrial fibrillation, the method comprising: mapping, using a diagnostic mapping mesh, a mapping site proximate a target tissue site and a protected tissue; receiving a plurality of electrical signals from the diagnostic mapping mesh, the plurality of electrical signals indicative of ablation of the target tissue site; determining a control parameter based at least in part on (a) a threshold energy (“E1”) to stimulate a protected tissue, (b) a first time (“T1”) corresponding to detected ablation based on the received plurality of electrical signals, and (c) a treatment time (“Tt”) corresponding to an amount of time of application of ablation, the treatment time being a function of a ratio of the threshold energy over a predetermined constant threshold (“E2”) corresponding to a safe distance from the protected tissue; and adjusting treatment based on the control parameter.
  15. 51 . The method of claim 50 , comprising determining treatment success based on the first time corresponding to the determination of a change in the plurality of received electrical signals.
  16. 52 . The method of claim 50 , comprising determining treatment success based on a spatial pattern of the change in the plurality of received electrical signals.
  17. 53 . The method of claim 52 , comprising applying, using a treatment device, further treatment following the adjusting treatment.
  18. 54 . The method of claim 53 , the treatment device comprising an ablation device.
  19. 55 . The method of claim 54 , the ablation device comprising a cryoablation device.
  20. 56 . The method of claim 55 , wherein the adjustment of treatment based on the control parameter comprises adjustment of a cryoablation fluid flow.

Description

INCORPORATION BY REFERENCE The present application is a continuation of U.S. application Ser. No. 17/119,783, filed Dec. 11, 2020, entitled TISSUE MAPPING AND TREATMENT, which is a continuation-in-part of U.S. application Ser. No. 15/396,309, filed Dec. 30, 2016, entitled TISSUE MAPPING AND TREATMENT, which claims priority benefit to U.S. Prov. App. No. 62/273,268, filed Dec. 30, 2015, entitled PHRENIC NERVE LOCATION AND INJURY PREVENTION. U.S. application Ser. No. 17/119,783 also claims priority benefit to U.S. Prov. App. No. 62/947,471, filed Dec. 12, 2019, entitled TISSUE MAPPING AND TREATMENT, all of which are incorporated herein in their entireties. BACKGROUND In many medical procedures, catheters are used to treat tissue. In some procedures, it may be valuable to map the location of certain extravascular structures, to potentially influence the execution of the index procedure. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagram illustrating an embodiment of a treatment system. FIG. 2 is a diagram illustrating an embodiment of a mapping system. FIG. 3 is a diagram illustrating an embodiment of a cryoablation treatment system. FIG. 4A is a diagram illustrating an embodiment of a mapping device of an intravenous catheter is positioned within the right superior pulmonary vein. FIG. 4B is a diagram illustrating an embodiment of a treatment device positioned within the right superior pulmonary vein. FIGS. 5A, 5B, 5C, 5D are diagrams illustrating embodiments of a complementary mapping device and treatment device in different configurations and positions. FIG. 6 is a diagram illustrative of an embodiment of a complementary mapping device and treatment device positioned within the right superior pulmonary vein. FIG. 7 is a flow diagram illustrating an embodiment of a routine for treating cardiac arrhythmia. FIG. 8 is a flow diagrams illustrating an embodiment of a routine for treating a tissue site. FIGS. 9, 10A and 10B are diagrams illustrating embodiments of treatment elements that include multiple segments. FIGS. 11 and 12 are diagrams illustrating embodiments of a treatment device that includes one or more sensor/electrodes. FIG. 13 is a diagram illustrative of an embodiment of a treatment device positioned within the right superior pulmonary vein. FIG. 14 is a flow diagram illustrating an embodiment of a routine for treating a tissue site. FIGS. 15A-15D are diagrams illustrative of a mapping overlay. FIGS. 16A-16C are diagrams illustrating embodiments of a mapping overlay and a treatment device in different configurations and positions. FIGS. 17A-17B show coaxial introduction of a treatment catheter into the basket of a mapping catheter. FIGS. 18A-18C show coaxial introduction as in FIGS. 17B-17B, into a basket having a circumferential wire spacing stabilizing feature. FIGS. 19A-19B show parallel introduction of the mapping catheter and the treatment catheter, with the treatment element entering the mapping catheter cavity through the wire mesh side wall. FIGS. 20A-20B illustrate filament braid patterns. FIG. 21 shows a cryo balloon inside of a mapping array, with an ice ball. FIGS. 22-26 show electrograms from mapping devices in accordance with the present invention. DETAILED DESCRIPTION During medical procedures using catheters, it can be difficult to identify tissue proximate to the catheter. Furthermore, in some cases, when the tissue is being treated it can be difficult to monitor the effects of the treatment on tissue proximate the tissue that is to be treated. A method and device described herein can be used as part of or in conjunction with a treatment device to map tissue at or near a target site and monitor the tissue at or near the target site during treatment. In same embodiments, the device can be used in conjunction with a treatment device used to treat cardiac arrhythmia. However, it will be understood that the methods and device described herein can be used with many types of treatment devices. Cardiac Arrhythmia Cardiac arrhythmia, a condition in which the heart's normal rhythm is disrupted, includes many different forms. For example, cardiac arrhythmia includes premature atrial contractions (PACs), atrial flutter, accessory pathway tachycardias, atrial fibrillation, atrioventricular (AV) nodal reentrant tachycardia (AVNRT), premature ventricular contractions (PVCs), ventricular tachycardia (VT), ventricular fibrillation, long QT syndrome, and bradyarrhythmias. Certain types of cardiac arrhythmias, including atrial fibrillation (AF), may be treated by ablation (for example, radiofrequency (RF) ablation, cryoablation, ultrasound ablation, laser ablation, and the like), either endocardially or epicardially. As mentioned above, one method of ablating tissue of the heart and pulmonary veins to control atrial fibrillation includes delivering radiofrequency (RF) energy to the tissue to be ablated. In particular, high frequency energy can be employed, for example, to cause ionic agitation and