Device and method for positioning an electrode in a body cavity

• US 10,232,170 B2
• Filed: 12/15/2017
• Issued: 03/19/2019
• Est. Priority Date: 05/09/2014
• Status: Active Grant

• Current Assignee: BioTrace Medical, Inc. (Merit Medical Systems, Inc.)
• Original Assignee: BioTrace Medical, Inc. (Merit Medical Systems, Inc.)
• Inventors: Sparks, Kurt, Garai, Ellis, Swaminathan, Aravind, Dietch, Laura, Sicotte, Marcel
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/844,367
• Publication Number:
  US 20180126156A1
• Time in Patent Office: 459 Days
• Field of Search: None
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6879 Means for maintaining contact with the body A61B5/6847 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/058 Fixing tools

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

1. An electrical sensing/stimulation apparatus for positioning at least one electrode within body tissue, the electrical sensing/stimulation apparatus comprising:

an elongate lead body having a longitudinal axis and at least one internal lumen;

at least one sensing/stimulation electrode coupled to the elongate lead body;

a deployable/retractable displacement member coupled to the elongate lead body and adapted to move or bias the at least one electrode towards a prescribed direction by a user; and

a tissue attachment mechanism adapted to affix a distal segment of the elongate lead body to body tissue, the tissue attachment mechanism having a retracted configuration and a deployed configuration,

wherein in the retracted configuration the tissue attachment mechanism is positioned substantially within the at least one internal lumen, and in the deployed

configuration the tissue attachment mechanism extends from the longitudinal axis of the elongate lead body to engage body tissue, and

wherein the deployable/retractable displacement member comprises an expandable member having a collapsed configuration and an expanded configuration, and

wherein the expandable member in the collapsed configuration has an outer perimeter greater than an outer circumference of the elongate lead body, and

wherein the expandable member in the collapsed configuration does not extend from an outer surface of the elongate lead body.

2. The electrical sensing/stimulation apparatus of claim 1, wherein the at least one sensing/stimulation electrode comprises a first electrode and a second electrode.

3. The electrical sensing/stimulation apparatus of claim 2, wherein the first electrode and second electrode are axially separated from one another.

4. The electrical sensing/stimulation apparatus of claim 2, wherein the deployable/retractable displacement member is disposed between the first and second electrodes.

5. The electrical sensing/stimulation apparatus of claim 1, wherein the expandable member is adapted to deploy out of a lateral side of the elongate lead body.

6. The electrical sensing/stimulation apparatus of claim 1, wherein the expandable member is at least partially folded onto itself in the collapsed configuration.

7. The electrical sensing/stimulation apparatus of claim 6, wherein the expandable member in the collapsed configuration has a C-shaped, E-shaped, spiral shaped, serpentine shaped, or star shaped cross-section.

8. The electrical sensing/stimulation apparatus of claim 1, further comprising a radiopaque marker mounted on an outer surface of the expandable member.

9. The electrical sensing/stimulation apparatus of claim 8, wherein the radiopaque marker is expandable in conjunction with the expandable member.

10. The electrical sensing/stimulation apparatus of claim 8, wherein the expandable member is inflatable.

11. The electrical sensing/stimulation apparatus of claim 10, wherein the elongate lead body has an inflation lumen to provide an inflation medium to inflate the expandable member.

12. The electrical sensing/stimulation apparatus of claim 8, wherein the expandable member comprises a malecot or expandable cage.

13. The electrical sensing/stimulation apparatus of claim 8, wherein the expandable member in the expanded configuration is shaped to match the cavity of a bodily organ or space.

14. A method for positioning an electrical sensing/stimulation device within body tissue, the method comprising:

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

torqueing the elongate lead body to align at least one tissue attachment member of the electrical sensing/stimulation device with a target tissue in the target site;

deploying a displacement member to bias the elongate lead body and the at least one tissue attachment member against the target tissue, wherein the displacement member comprises an expandable member having a collapsed configuration and an expanded configuration, and wherein the expandable member in the collapsed configuration has an outer perimeter greater than an outer circumference of the elongate lead body, and wherein deploying the displacement member comprises expanding the displacement member to a shape matching a shape of the bodily cavity; and

actuating the at least one tissue attachment member to extend from at least one tissue anchor deployment port on the elongate lead body and into the target tissue to affix a distal portion of the elongate lead body and at least one electrode of the electrical sensing/stimulation device to the target tissue.

15. The method of claim 14, 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 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.

16. The method of claim 14, wherein the displacement member comprises an expandable element and deploying the displacement member comprises inflating the expandable member.

17. The method of claim 14, wherein the expandable member in the collapsed configuration does not extend from an outer surface of the elongate lead body.

18. The method of claim 14, wherein the expandable member is at least partially folded onto itself in the collapsed configuration.

19. An electrical sensing/stimulation apparatus for positioning at least one electrode within body tissue, the electrical sensing/stimulation apparatus comprising:

an elongate lead body having a longitudinal axis and at least one internal lumen;

at least one sensing/stimulation electrode coupled to the elongate lead body;

an expandable displacement member coupled to the elongate lead body and adapted to move or bias the at least one electrode towards a prescribed direction by a user, the expandable displacement member having a shape matching a cavity of a bodily organ or space when expanded, and wherein the expandable member when collapsed has an outer perimeter greater than an outer circumference of the elongate lead body; and

a tissue attachment mechanism adapted to affix a distal segment of the elongate lead body to body tissue, the tissue attachment mechanism having a retracted configuration and a deployed configuration,

wherein in the retracted configuration the tissue attachment mechanism is positioned substantially within the at least one internal lumen, and in the deployed configuration the tissue attachment mechanism extends from the longitudinal axis of the elongate lead body to engage body tissue.

20. The electrical sensing/stimulation apparatus of claim 19, wherein the at least one sensing/stimulation electrode comprises a first electrode and a second electrode.

21. The electrical sensing/stimulation apparatus of claim 20, wherein the first electrode and second electrode are axially separated from one another.

22. The electrical sensing/stimulation apparatus of claim 21, wherein the expandable displacement member is disposed between the first and second electrodes.

23. The electrical sensing/stimulation apparatus of claim 19, wherein the expandable member when collapsed does not extend from an outer surface of the elongate lead body.

24. The electrical sensing/stimulation apparatus of claim 19, wherein the expandable displacement member is at least partially folded onto itself in the collapsed configuration.

25. The electrical sensing/stimulation apparatus of claim 24, wherein the expandable member in the collapsed configuration has a C-shaped, E-shaped, spiral shaped, serpentine shaped, or star shaped cross-section.

26. The electrical sensing/stimulation apparatus of claim 19, further comprising a radiopaque marker mounted on an outer surface of the expandable displacement member.

27. The electrical sensing/stimulation apparatus of claim 26, wherein the radiopaque marker is expandable in conjunction with the expandable displacement member.

28. The electrical sensing/stimulation apparatus of claim 27, wherein the expandable displacement member is inflatable.

29. The electrical sensing/stimulation apparatus of claim 28, wherein the elongate lead body has an inflation lumen to provide an inflation medium to inflate the expandable displacement member.