IP Library Granted Patent US 12,076,555
Granted Patent B2
US 12,076,555 · App. 17/178,099 · Granted Sep 3, 2024

Device and method for positioning an electrode in a body cavity

Inventors: Kurt Sparks (Palo Alto, CA); Ellis Garai (Palo Alto, CA); Aravind Swaminathan (San Mateo, CA); Laura Dietch (Menlo Park, CA); Marcel Sicotte (San Francisco, CA)
Assignee: Merit Medical Systems, Inc.
A61N1/0558A61B5/29A61B6/12A61N1/057A61N1/0573A61B5/0215A61B5/024A61B5/287A61B5/686A61B5/6879A61B2017/22071A61B2090/3966A61B2562/0209A61N2001/0578A61N2001/058A61N1/36017
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Quick Facts
Patent No.
US 12,076,555
App. No.
17/178,099
Granted
Sep 3, 2024
Kind
B2
Abstract

Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.

Claims (38)

1. A method for positioning an electrical sensing or stimulation device within a bodily cavity, the method comprising:

advancing an elongate lead body of the electrical sensing or stimulation device to position the elongate lead body at a target site in the bodily cavity; and

extending a plurality of tissue attachment members from the elongate lead body from a common port and diverge from each other and into or against the target tissue to affix a distal portion of the lead body to target tissue at the target site and contact at least one electrode of the electrical sensing or stimulation device to the target tissue,

wherein extending the plurality of tissue attachment members comprises translating a single wire coupled to the plurality of tissue attachment members within a lumen of the elongate lead body.

2. The method of claim 1 , wherein translating the single wire comprises advancing the single wire relative to the elongate lead body to cause the plurality of tissue attachment members to extend from the elongate lead body.

3. The method of claim 1 , wherein translating the single wire comprises retracting the single wire relative to the elongate lead body to cause the plurality of tissue attachment members to extend from the elongate lead body.

4. The method of claim 1 , wherein the plurality of tissue attachment members comprises a first tissue attachment member and a second tissue attachment member, and wherein the first and second tissue attachment members extend from a common deployment port of the electrical sensing or stimulation device.

5. The method of claim 1 , wherein the plurality of tissue attachment members comprises a first tissue attachment member and a second tissue attachment member, and

wherein the first and second tissue attachment members extend from different deployment ports of the electrical sensing or stimulation device.

6. The method of claim 1 , wherein the plurality of tissue attachment members comprises a first tissue attachment member and a second tissue attachment member, and wherein the first and second tissue attachment members diverge from one another when extended from the elongate lead body.

7. The method of claim 1 , further comprising deploying a displacement member of the electrical sensing or stimulation device to move or bias the elongate lead body against the target tissue.

8. The method of claim 1 , further comprising verifying proper affixation of the distal portion of the elongate lead body to the target tissue.

9. The method of claim 1 , further comprising sensing an electrical signal, conveying electrical stimulation, or both with the at least one electrode of the electrical sensing or stimulation device.

10. The method of claim 1 , wherein the plurality of tissue attachment members are extended from the elongate lead body simultaneously.

11. The method of claim 1 , wherein the at least one electrode comprises a first electrode and a second electrode, and wherein extending the plurality of tissue attachment members from the elongate lead body contacts the first and second electrodes to the target tissue.

12. The method of claim 1 , wherein the bodily cavity is at least a part of a right ventricle, a left ventricle, a right atrium, a left atrium, an aorta, a vena cava, an artery, a vein, a substernal extracardial location, a bladder, a ureter, a uterus, a nasal cavity, an oral cavity, an esophagus, a stomach, an intestine, a gall bladder, a colon, or a rectum.

13. The method of claim 1 , wherein a portion of each tissue attachment member of the plurality of tissue attachment members is attached side by side along the single wire.

14. An electrical sensing or stimulation device for placement within a bodily cavity, the device comprising:

an elongate lead body having a longitudinal axis;

at least one electrode coupled to the elongate lead body; and

a tissue attachment assembly comprising a plurality of tissue attachment members and a single wire coupled to the plurality of tissue attachment members,

wherein the single wire is configured to be translated within a lumen of the elongate lead body to extend the plurality of tissue attachment members from a common port of the elongate lead body and diverge from each other to affix a distal portion of the elongate lead body to target tissue at a target site in the bodily cavity and contact the at least one electrode to the target tissue.

15. The device of claim 14 , wherein the single wire is configured to be advanced relative to the elongate lead body to extend the plurality of tissue attachment members from the elongate lead body.

16. The device of claim 14 , wherein the single wire is configured to be retracted relative to the elongate lead body to extend the plurality of tissue attachment members from the elongate lead body.

17. The device of claim 14 , wherein the elongate lead body comprises a common deployment port and the plurality of tissue attachment members are configured to extend from the common deployment port.

18. The device of claim 14 , wherein the elongate lead body comprises a plurality of deployment ports and the plurality of tissue attachment members are configured to extend from different deployment ports.

19. The device of claim 14 , wherein the first and second tissue attachment members are adapted to diverge from one another when extended from the elongate lead body.

20. The device of claim 14 , further comprising a deployable or retractable displacement member coupled to the elongate lead body and adapted to move or bias the elongate lead body against the target tissue.

21. The device of claim 14 , further comprising a radiopaque marker.

22. The device of claim 14 , wherein the device is configured to sense an electrical signal, convey electrical stimulation, or both with the at least one electrode.

23. The device of claim 14 , wherein the plurality of tissue attachment members are configured to be extended from the elongate lead body simultaneously.

24. The device of claim 14 , wherein the plurality of tissue attachment members comprises a first tissue attachment member coupled to the single wire at a first location and a second tissue attachment member coupled to the single wire at a second location.

25. The device of claim 24 , wherein the first and second locations are different axial locations along the single wire.

26. The device of claim 24 , wherein the first and second locations are the same axial location along the single wire.

27. The device of claim 14 , wherein at least one of the attachment members has the shape of a curved loop when extended from the elongate lead body.

28. The device of claim 14 , further comprising an atraumatic distal tip.

29. The device of claim 14 , further comprising a proximal control handle.

30. The device of claim 14 , wherein a portion of each tissue attachment member of the plurality of tissue attachment members is attached side by side along the single wire.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2022
From: BIOTRACE MEDICAL, INC.
To: MERIT MEDICAL SYSTEMS, INC.
Reel/Frame 061382/0509 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 17, 2021
From: SPARKS, KURT; GARAI, ELLIS; SWAMINATHAN, ARAVIND; DIETCH, LAURA; SICOTTE, MARCEL
To: BIOTRACE MEDICAL, INC.
Reel/Frame 055301/0054 →
Continuity (5)
Continuation 16256473 · Jan 24, 2019
Continuation 15844367 · Dec 15, 2017
Continuation 14707246 · May 8, 2015
Provisional Application 61990998 · May 9, 2014
Related Publication 20210236812A1 · Aug 5, 2021