# US 12,179,030 B2 · Biostimulator having coaxial fixation elements

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- Number: US 12,179,030 B2
- Document ID: US12179030B2
- Status: Granted
- Kind: B2
- Application number: 17/994,988
- Filed: 2022-11-28
- Published: 2023-03-23
- Granted: 2024-12-31
- Earliest claimed: 2019-03-15
- Assignees: Pacesetter, Inc.
- Applicants: Pacesetter, Inc.
- Inventors: Thomas B. Eby; Tyler J. Strang; Keith Victorine; Wesley Alleman
- Web page: https://patentgrep.com/patent/US12179030B2

## CPC

- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 1/37512: {Pacemakers}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61N 1/0573: {chacterised by means penetrating the heart tissue, e.g. helix needle or hook}
- A61N 2001/0578: {having means for removal or extraction}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue, is described. The coaxial fixation elements include an outer fixation element extending along a longitudinal axis and an inner fixation element radially inward from the outer fixation element. One or more of the fixation elements are helical fixation elements that can be screwed into tissue. The outer fixation element has a distal tip that is distal to a distal tip of the inner fixation element, and an axial stiffness of the outer fixation element is lower than an axial stiffness of the inner fixation element. The relative stiffnesses are based on one or more of material or geometric characteristics of the respective fixation elements. Other embodiments are also described and claimed.

## Claims

### Claim 1

A biostimulator, comprising:
a housing containing an electronics compartment and including a flange having a longitudinal axis, wherein the flange includes a distal hub including a first threaded segment having first external threads extending about the longitudinal axis over a first circumferential width, a second threaded segment having second external threads extending about the longitudinal axis over a second circumferential width, and an outward surface extending about the longitudinal axis over a third circumferential width between the first circumferential width and the second circumferential width to circumferentially separate the first threaded segment from the second threaded segment; and
a helix mount mounted on the housing, wherein the helix mount includes an inner surface engaging the plurality of interrupted external threads.

### Claim 2 (depends on 1)

The biostimulator of claim 1, wherein the first threaded segment and the second threaded segment are distributed about the flange and separated from each other by the outward surface.

### Claim 3 (depends on 2)

The biostimulator of claim 2, wherein the outward surface includes one or more external longitudinal slots.

### Claim 4 (depends on 3)

The biostimulator of claim 3, wherein the external longitudinal slots have external slot surfaces on the outward surface that are radially nearer to the longitudinal axis than a minor diameter of the first external threads and the second external threads.

### Claim 5 (depends on 1)

The biostimulator of claim 1, wherein the helix mount includes a plurality of interrupted internal threads on the inner surface engaging the first external threads and the second external threads.

### Claim 6 (depends on 5)

The biostimulator of claim 5, wherein the plurality of interrupted internal threads are disposed on a plurality of blanks distributed about the inner surface of the helix mount and separated from each other by one or more internal thread interruptions.

### Claim 7

A biostimulator, comprising:
a helix mount including a plurality of interrupted internal threads extending about a longitudinal axis; and
a housing containing an electronics compartment and including a flange having a longitudinal axis, wherein the flange includes a distal hub including a first threaded segment having first external threads extending about the longitudinal axis over a first circumferential width, a second threaded segment having second external threads extending about the longitudinal axis over a second circumferential width, and an outward surface extending about the longitudinal axis over a third circumferential width between the first circumferential width and the second circumferential width to circumferentially separate the first threaded segment from the second threaded segment, and wherein the first external threads and the second external threads engage the plurality of interrupted internal threads.

### Claim 8 (depends on 7)

The biostimulator of claim 7, wherein the plurality of interrupted internal threads are disposed on a plurality of blanks distributed about an inner surface of the helix mount and separated from each other by one or more internal thread interruptions.

### Claim 9 (depends on 8)

The biostimulator of claim 8, wherein the one or more internal thread interruptions include one or more internal longitudinal slots.

### Claim 10 (depends on 9)

The biostimulator of claim 9, wherein the internal longitudinal slots have internal slot surfaces that are radially farther from the longitudinal axis than a blank diameter of the plurality of blanks.

### Claim 11 (depends on 7)

The biostimulator of claim 7, wherein a cross-sectional profile of an inner surface of the helix mount matches a cross-sectional profile of the flange.

### Claim 12 (depends on 7)

The biostimulator of claim 7, wherein the plurality of interrupted internal threads of the helix mount are softer than the first external threads and the second external threads of the flange.

### Claim 13 (depends on 7)

The biostimulator of claim 7, wherein an angular width of one of the plurality of interrupted external threads is greater than another one of the first external threads.

### Claim 14 (depends on 7)

The biostimulator of claim 7, wherein the first threaded segment and the second threaded segment are distributed about the flange and separated from each other by the outward surface.

### Claim 15

A method, comprising:
inserting a helix mount over a flange of a housing, wherein the helix mount includes a plurality of slots, wherein the flange includes a distal hub having a longitudinal axis, wherein the flange includes a distal hub including a first threaded segment having first external threads extending about the longitudinal axis over a first circumferential width, a second threaded segment having second external threads extending about the longitudinal axis over a second circumferential width, and an outward surface extending about the longitudinal axis over a third circumferential width between the first circumferential width and the second circumferential width to circumferentially separate the first threaded segment from the second threaded segment, the outward surface separating a plurality of interrupted external threads extending about the longitudinal axis, and wherein the plurality of slots are to receive the first external threads and the second external threads of the flange; and
rotating the helix mount relative to the flange to engage the plurality of interrupted external threads of the flange to a plurality of interrupted internal threads of the helix mount.

### Claim 16 (depends on 15)

The method of claim 15, wherein rotating the helix mount causes the first external threads and the second external threads to cut the plurality of interrupted internal threads into the helix mount.

### Claim 17 (depends on 15)

The method of claim 15, wherein the plurality of interrupted internal threads are pre-formed on an inner surface of the helix mount, and wherein rotating the helix mount causes the first external threads and the second external threads to engage the plurality of interrupted internal threads.

### Claim 18 (depends on 15)

The method of claim 15, wherein the plurality of interrupted internal threads of the helix mount are softer than the first external threads and the second external threads of the flange.

### Claim 19 (depends on 15)

The method of claim 15, wherein a cross-sectional profile of an inner surface of the helix mount matches a cross-sectional profile of the flange.
