IP Library Granted Patent US 11,154,239
Granted Patent B2
US 11,154,239 · App. 15/769,184 · Granted Oct 26, 2021

Controlled and precise treatment of cardiac tissues

Inventors: Landy Toth (Doylestown, PA); Robert S. Schwartz (Inver Grove Heights, MN)
Assignee: Autonomix Medical, Inc.
A61B5/4839A61B5/0215A61B5/282A61B5/4848A61B5/6858A61B5/6869A61B18/1492A61N1/36135A61B5/0059A61B5/0205A61B5/02028A61B5/08A61B5/1473A61B5/201A61B5/287A61B5/316A61B5/352A61B2018/00351A61B2018/00577A61B2018/00702A61B2018/00839A61B2505/05A61B2562/0247A61B2562/0261A61B2576/023
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Quick Facts
Patent No.
US 11,154,239
App. No.
15/769,184
Filed
Apr 18, 2018
Granted
Oct 26, 2021
Kind
B2
Art Unit
3791
USPC
600/585
Abstract

Systems, devices, and methods for performing precise treatment, mapping, and/or testing of tissues are disclosed. Systems, devices, and methods for administering an agent to one or more a precise regions within a tissue mass are disclosed. Systems, devices, and methods for treating targeted regions within a tissue mass are disclosed. Systems, devices, and methods for identifying, localizing, monitoring neural traffic in the vicinity of, quantifying neural traffic in the vicinity of, and mapping neural traffic near targeted regions within a tissue mass are disclosed.

Claims (54)

1. A system for treating a neural site in a body comprising:

a therapeutic substance in a reservoir;

a catheter comprising a lumen coupled to at least one delivery tip and the reservoir;

a controller configured:

to project the at least one delivery tip outwards from the catheter into a treatment site within the body upon deployment; and

to deliver a bolus of the therapeutic substance through the lumen and the at least one delivery tip during use;

wherein the at least one delivery tip comprises at least one of one or more electrodes and one or more sensors configured to monitor a margin of migration of the bolus of the therapeutic substance delivered through the lumen into the treatment site;

wherein the treatment site comprises a thin walled section adjacent a structure in the body; and

wherein the controller is further configured:

to advance the at least one delivery tip at least one of into and against the thin walled section; and

to deliver the bolus of the therapeutic substance into the thin walled section without treating the structure in the body adjacent the thin walled section.

2. The system in accordance with claim 1 , wherein the at least one delivery tip comprises a plurality of openings arranged along a length thereof, the plurality of openings coupled with the lumen.

3. The system in accordance with claim 2 , wherein the openings plurality of openings are sized such that a substantially equal amount of the therapeutic substance is delivered through each of the plurality of openings during delivery.

4. The system in accordance claim 1 , further comprising an adjustable stop with an adjustable distance setting, the adjustable stop configured to prevent the at least one delivery tip from projecting more than the adjustable distance beyond the adjustable stop.

5. The system in accordance with claim 4 , wherein the adjustable stop is configured to abut against a vessel wall during deployment such that the at least one delivery tip is oriented substantially in a direction perpendicular to the vessel wall during deployment.

6. The system in accordance with claim 1 , further comprising a sensing element configured to sense neural traffic in a vicinity of the neural site during deployment, the sensing element being integrated into the at least one delivery tip.

7. The system in accordance with claim 1 , wherein the controller is configured to adjust an injected bolus volume dependent upon pressure and flow characteristics of the bolus during injection.

8. The system in accordance with claim 7 , wherein the controller is configured to compensate for at least one of volume of the lumen and pressure dependent compression of the bolus during injection to deliver an intended bolus volume to the neural site.

9. The system in accordance with claim 1 , wherein the lumen is tapered proximate the at least one delivery tip to reduce pressure loss during injection of the therapeutic substance into the neural site.

10. The system in accordance with claim 1 , wherein the lumen has a first diameter in a region of the catheter closest to the catheter and a second diameter in a region proximate the at least one delivery tip, the first diameter being larger than the second diameter.

11. The system in accordance with claim 1 , further comprising a plurality of therapeutic substances, the system being configured to selectively deliver a particular type and bolus volume of at least one of the plurality of therapeutic substances based at least in part on a selected treatment.

12. The system in accordance with claim 1 , further comprising a bolus staging loader, the bolus staging loader configured to stage a sequence of therapeutic substance and bolus size combinations into the lumen prior to delivery of the therapeutic substance to the treatment site.

13. The system in accordance with claim 1 , wherein at least one of a type, a sequence and a bolus size of one or more boluses of the therapeutic substance is determined based at least in part on neural traffic sensed utilizing the at least one of the one or more electrodes and the one or more sensors.

14. The system in accordance with claim 1 , wherein the catheter comprises a plurality of lumens coupled with the at least one delivery tip, the system being configured to selectively deliver a therapeutic substance from one or more of the plurality of lumens through the at least one delivery tip.

15. The system in accordance with claim 14 , wherein the catheter comprises a manifold to couple the plurality of lumens to the at least one delivery tip to substantially minimize a volume of the therapeutic substance located between the manifold and one or more openings of the at least one delivery tip.

16. The system in accordance with claim 1 , wherein the at least one of the one or more electrodes and the one or more sensors are configured to monitor the margin of migration of the bolus of the therapeutic substance based at least in part on changes in at least one of impedance and local electrophysiological signals.

17. The system in accordance with claim 1 , wherein the lumen comprises a first sensing zone located along a length thereof for interfacing a wall of the lumen proximal to the treatment site and a second sensing zone located at a tip of the lumen for interfacing the lumen distally to the treatment site.

18. The system in accordance with claim 1 , wherein the controller is further configured to advance the at least one delivery tip into the thin walled section without penetrating the adjacent structure.

19. The system in accordance with claim 1 , wherein the controller is further configured to bias the at least one delivery tip against the thin walled section without penetrating the thin walled section.

20. The system of claim 1 , wherein the at least one delivery tip comprises a needle.

21. The system of claim 1 , wherein the at least one delivery tip at least one of comprises one or more radiopaque markers and comprises one or more radiopaque materials.

22. The system of claim 1 , wherein the at least one delivery tip comprises an insulating layer along at least a portion of a length of the at least one delivery tip.

23. A system for treating a neural site in a body comprising:

a therapeutic substance in a reservoir;

a catheter comprising a lumen coupled to at least one delivery tip and the reservoir;

a controller configured:

to project the at least one delivery tip outwards from the catheter into a treatment site within the body upon deployment; and

to deliver a bolus of the therapeutic substance through the lumen and the at least one delivery tip during use;

wherein the at least one delivery tip comprises at least one of one or more electrodes and one or more sensors configured to monitor a margin of migration of the bolus of the therapeutic substance delivered through the lumen into the treatment site;

wherein the controller is further configured:

to bias an end of the lumen against a wall of the treatment site to seal the lumen against the wall of the treatment site;

to apply at least one of a vacuum and suction to the lumen to draw a section of tissue at the treatment site into the end of the lumen;

to penetrate the at least one delivery tip into the section of the tissue drawn into the end of the lumen; and

to deliver the bolus of the therapeutic substance into section of the tissue drawn into the end of the lumen.

24. A system for treating a neural site in a body comprising:

a therapeutic substance in a reservoir;

a catheter comprising a lumen coupled to at least one delivery tip and the reservoir;

a controller configured:

to project the at least one delivery tip outwards from the catheter into a treatment site within the body upon deployment; and

to deliver a bolus of the therapeutic substance through the lumen and the at least one delivery tip during use;

wherein the at least one delivery tip comprises at least one of one or more electrodes and one or more sensors configured to monitor a margin of migration of the bolus of the therapeutic substance delivered through the lumen into the treatment site;

wherein the at least one delivery tip comprises an insulating layer along at least a portion of a length of the at least one delivery tip; and

wherein the insulating layer has a varying thickness along the length of the at least one delivery tip.

25. The system of claim 24 , wherein the varying thickness of the insulating layer along the length of the at least one delivery tip comprises one or more step transitions configured to limit a depth of penetration of the at least one delivery tip into the treatment site.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 18, 2018
From: TOTH, LANDY; SCHWARTZ, ROBERT S.
To: AUTONOMIX MEDICAL, INC.
Reel/Frame 045576/0176 →
Continuity (2)
Provisional Application 62244322 · Oct 21, 2015
Related Publication 20180303414A1 · Oct 25, 2018
Cited By (9)
US 12,232,991 US 12,453,630 US 12,582,520 US 12,588,988 US 12,588,989 US 12,588,998 US 12,594,164 US 12,599,481 US 12,636,146