Electrode fixation in interventional medical systems

• US 10,238,865 B2
• Filed: 10/06/2016
• Issued: 03/26/2019
• Est. Priority Date: 10/06/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonner, Matthew D, Usher, Raymond W, Whitman, Teresa A, Carver, Jean M, Hilpisch, Kathryn
• Primary Examiner(s): Voorhees, Catherine M
• Application Number:
  US15/287,122
• Publication Number:
  US 20180099138A1
• Time in Patent Office: 901 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable medical device assembly includes a mounting structure, an electrode protruding from a surface of the structure, between opposing sides thereof, and tissue-penetrating fixation tines, each extending from a corresponding shoulder of the structure surface, adjacent to the opposing sides. In a relaxed condition, each tine extends away from the surface and then bends toward a proximal end of the structure and back toward the surface. In an extended condition, each tine bends toward a distal end of the structure and extends along the corresponding shoulder. A holding member of a delivery tool has opposing sidewalls defining a cavity, wherein each sidewall includes a rail-like edge that fits in sliding engagement with a corresponding shoulder, to deform a corresponding tine into the extended condition, when an operator passes the assembly into the cavity. Applying a push force, to move the assembly back out form the cavity, releases the tines.

Claims

1. An implantable medical device assembly comprising:

a mounting structure having a length defined from a proximal end thereof to a distal end thereof, a thickness defined from a first surface thereof to a second surface thereof, and a width defined from a first side thereof to a second side thereof, the mounting structure comprising first and second shoulders formed in the first surface of the structure and aligned along the length of the structure, the first shoulder being adjacent to the first side of the structure, and the second shoulder being adjacent to the second side of the structure;

an electrode protruding from the first surface of the mounting structure; and

first and second tissue-penetrating fixation tines, each tine including a pre-formed V-shaped segment that extends away from a corresponding shoulder of the first surface of the mounting structure, being located on either side of the electrode so that the electrode is approximately centered therebetween, each segment including a piercing tip, and each segment being elastically deformable from a relaxed condition to an extended condition, the relaxed condition being that of the pre-formed V-shape, in which each segment bends toward the proximal end and the first surface of the mounting structure so that each piercing tip is located proximal to the electrode and away from the corresponding shoulder of the mounting structure, and the extended condition being that in which each segment bends toward the distal end of the mounting structure and extends along and within the corresponding shoulder of the mounting structure so that each piercing tip is located distal to the electrode.

2. The assembly of claim 1, wherein:

the mounting structure further comprises first and second internal channels located distal to the electrode; and

each fixation tine further includes a second segment extending in a corresponding channel of the first and second internal channels of the mounting structure.

3. The assembly of claim 2, wherein the second segment of each fixation tine comprises an L-shaped segment.

4. The assembly of claim 1, wherein the first surface of the mounting structure includes a conductive area forming another electrode for bipolar function with the electrode that protrudes from the first surface.

5. The assembly of claim 2, wherein:

each fixation tine has a generally rectangular axial cross-section, the axial cross-section being uniform along the both segments of the tine, sans the piercing tips, and longer sides of each axial cross-section being orthogonal to a single plane in which both segments of each tine bend; and

each fixation tine is oriented so that one of the longer sides of the axial cross section thereof faces toward the second surface of the mounting structure when the pre-formed V-shaped segment of each tine is deformed into the extended condition.

6. The assembly of claim 5, wherein the piercing tip of each fixation tine includes an angled surface, the angled surfaces facing generally toward one another.

7. The assembly of claim 1, wherein the mounting structure defines a hermetically sealed enclosure sized to hold an electronic controller and associated power source for coupling to the electrode.

8. The assembly of claim 7, further comprising an elongate electrode subassembly extending from the distal end of the mounting structure.

9. The assembly of claim 1, wherein the first surface of the mounting structure includes a concavity formed therein, the concavity being centered on the structure, and the electrode being located on a centerline of the concavity.

10. An interventional medical system comprising:

an implantable medical device assembly, the assembly comprising;

a mounting structure having a length defined from a proximal end thereof to a distal end thereof, a thickness defined from a first surface thereof to a second surface thereof, and a width defined from a first side thereof to a second side thereof, the mounting structure comprising first and second shoulders formed in the first surface of the structure and aligned along the length of the structure, the first shoulder being adjacent to the first side of the structure, and the second shoulder being adjacent to the second side of the structure;

an electrode protruding from the first surface of the mounting structure; and

first and second tissue-penetrating fixation tines, each tine including a pre-formed V-shaped segment that extends away from a corresponding shoulder of the first surface of the mounting structure, being located on either side of the electrode so that the electrode is approximately centered therebetween, each segment including a piercing tip, and each segment being elastically deformable from a relaxed condition to an extended condition, the relaxed condition being that of the pre-formed V-shape, in which each segment bends toward the proximal end and the first surface of the mounting structure so that each piercing tip is located proximal to the electrode and away from the corresponding shoulder of the mounting structure, and the extended condition being that in which each segment bends toward the distal end of the mounting structure and extends along and within the corresponding shoulder of the mounting structure so that the piercing tip is located distal to the electrode; and

a delivery tool comprising;

an elongate shaft extending from a proximal end thereof to a distal end thereof;

a holding member attached to the distal end of the shaft, the holding member including first and second opposing sidewalls defining a cavity therebetween, the cavity being sized to hold the device assembly therein, the cavity including a distal opening sized to allow passage of the device assembly therethrough, and each sidewall including a rail-like edge configured to fit in sliding engagement with a corresponding shoulder of the device assembly mounting structure; and

means for applying a push force to the device assembly mounting structure, when the device assembly is held in the holding member cavity; and

wherein, when the device assembly is passed into the cavity of the tool holding member through the distal opening thereof, with the rail-like edge of each holding member sidewall engaged with the corresponding shoulder of the mounting structure, the pre-formed V-shaped segment of each fixation tine is deformed into the extended condition by the rail-like edge of the corresponding sidewall.

11. The system of claim 10, wherein the means for applying the push force in the delivery tool comprises an ejector rod slideably engaged within the tool.

12. The system of claim 10, wherein the sidewall rail-like edges of the tool holding member define a longitudinally extending slot therebetween;

and, when the device assembly is held in the cavity of the holding member, the electrode of the device assembly extends through the slot.

13. The system of claim 12, wherein the first surface of the device assembly mounting structure includes a conductive area that forms a second electrode for bipolar function with the device assembly electrode;

and when the device assembly mounting structure is held in the cavity of the tool holding member, the second electrode is exposed through the slot of the holding member.

14. The system of claim 10, wherein the device assembly further comprises an elongate electrode subassembly extending from the distal end of the mounting structure.

15. An interventional medical system comprising:

an implantable medical device assembly, the assembly comprising;

a mounting structure having a length defined from a proximal end thereof to a distal end thereof, a thickness defined from a first surface thereof to a second surface thereof, and a width defined from a first side thereof to a second side thereof, the mounting structure comprising first and second shoulders formed in the first surface of the structure and aligned along the length of the structure, the first shoulder being adjacent to the first side of the structure, and the second shoulder being adjacent to the second side of the structure;

an electrode protruding from the first surface of the mounting structure; and

first and second tissue-penetrating fixation tines, each tine including a pre-formed V-shaped segment that extends away from a corresponding shoulder of the first surface of the mounting structure, being located on either side of the electrode so that the electrode is approximately centered therebetween, each segment including a piercing tip, and each segment being elastically deformable from a relaxed condition to an extended condition, the relaxed condition being that of the pre-formed V-shape, in which each segment bends toward the proximal end and the first surface of the mounting structure so that each piercing tip is located proximal to the electrode, and the extended condition being that in which each segment bends toward the distal end of the mounting structure and extends along the corresponding shoulder of the mounting structure so that the piercing tip is located distal to the electrode; and

a delivery tool comprising;

an elongate shaft extending from a proximal end thereof to a distal end thereof; and

a holding member attached to the distal end of the shaft, the holding member including first and second opposing sidewalls defining a cavity therebetween, the cavity being sized to hold the device assembly therein, the cavity including a distal opening sized to allow passage of the device assembly therethrough, and each sidewall including a rail-like edge configured to fit in sliding engagement with a corresponding shoulder of the device assembly mounting structure, the rail-like edges defining a longitudinally extending slot therebetween; and

wherein, when the device assembly is passed into the cavity of the tool holding member through the distal opening thereof, with the rail-like edge of each holding member sidewall engaged with the corresponding shoulder of the mounting structure, the pre-formed V-shaped segment of each fixation tine is deformed into the extended condition by the rail-like edge of the corresponding sidewall; and

when the device assembly is held in the cavity of the holding member, the electrode of the device assembly extends through the slot defined by the rail-like edges of the holding member sidewalls.

16. The system of claim 15, wherein the first surface of the device assembly mounting structure includes a conductive area that forms a second electrode for bipolar function with the device assembly electrode;

and when the device assembly mounting structure is held in the cavity of the tool holding member, the second electrode is exposed through the slot of the holding member.

17. The system of claim 15, wherein the device assembly further comprises an elongate electrode subassembly extending from the distal end of the mounting structure.