# US 12,213,877 B2 · Nasal implants and systems and method of use

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- Number: US 12,213,877 B2
- Document ID: US12213877B2
- Status: Granted
- Kind: B2
- Application number: 17/214,869
- Filed: 2021-03-28
- Published: 2021-07-15
- Granted: 2025-02-04
- Earliest claimed: 2014-08-26
- Assignees: Stryker Corporation
- Applicants: Spirox, Inc.
- Inventors: Michael H. Rosenthal; Scott J. Baron; Donald A. Gonzales; Iyad S. Saidi
- Web page: https://patentgrep.com/patent/US12213877B2

## CPC

- A61F 2/186: {Nose parts}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like}
- A61B 2090/0811: {for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument}
- A61F 5/56: Devices for preventing snoring
- A61F 2210/0004: bioabsorbable
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/006: Y-shaped
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0025: differing in roughness
- A61F 2250/0026: differing in surface structures
- A61F 2250/0029: differing in bending or flexure capacity
- A61F 2250/003: differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F 2250/0039: differing in diameter
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools. A tool may include a hand-held implant delivery device that holds, moves, orients, inserts, or shapes an implant. An implant may be a biodegradable, longitudinal implant that may be oriented for implantation by an implant delivery device.

## Claims

### Claim 1

A system comprising:
a nasal implant delivery tool, the nasal implant delivery tool comprising:
a handle;
a needle extending distally from the handle, wherein the needle has a needle lumen,
a loading chamber communicating with the needle lumen, and
an actuator configured to move a nasal implant along the needle lumen and out of an opening at a distal end of the needle; and
a nasal implant having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end,
wherein the nasal implant includes a first arm and a second arm at the distal end of the nasal implant,
wherein the first arm and the second arm have (i) a contracted configuration in which the first arm and the second arm are contracted toward the central longitudinal axis and (ii) an expanded configuration in which the first arm and the second arm extend away from the central longitudinal axis by a greater extent than when the first arm and the second arm are in the contracted configuration,
wherein the first arm and the second arm are biased toward the expanded configuration, and
wherein the loading chamber of the nasal implant delivery tool is configured to:
receive the nasal implant into the nasal implant delivery tool, and
transition the nasal implant from the expanded configuration to the contracted configuration as the nasal implant moves through the loading chamber and into the needle lumen
wherein the loading chamber comprises a first lateral wall and a second lateral wall,
wherein, along a distal direction, a distance between the first lateral wall and the second lateral wall of the loading chamber narrows toward the central longitudinal axis,
wherein the first arm engages the first lateral wall and the second arm engages the second lateral wall responsive to the nasal implant moving through the loading chamber and into the needle lumen,
wherein the loading chamber further comprises a floor extending between the first lateral wall and the second lateral wall,
wherein the first lateral wall, the second lateral wall, a proximal wall, and a distal wall define an aperture of the loading chamber that opposes the floor,
wherein the aperture of the loading chamber comprises a proximal section, a distal section, and a shaping chamber section between the proximal section and the distal section, and
wherein the first lateral wall and the second lateral wall narrows toward the central longitudinal axis at the shaping chamber section,
wherein a distance between the first lateral wall and the second lateral wall is greater at the proximal section than the shaping chamber section, and
wherein a distance between the first lateral wall and the second lateral wall is greater at the distal section than the shaping chamber section the proximal wall and the distal wall of the loading chamber each comprise an aperture through which the actuator is configured to pass.

### Claim 2 (depends on 1)

The system of claim 1, wherein the loading chamber is configured to receive the nasal implant while the nasal implant is in the expanded configuration.

### Claim 3 (depends on 1)

The system of claim 1, wherein the actuator comprises a plunger that is configured to move the nasal implant in the loading chamber and the needle lumen.

### Claim 4 (depends on 1)

The system of claim 1, further comprising an actuator register configured to indicate a position of the actuator at which the nasal implant is at the distal end of the needle lumen.

### Claim 5 (depends on 4)

The system of claim 4, wherein the actuator register comprises one or more markings on the actuator or on the handle.

### Claim 6 (depends on 1)

The system of claim 1, further comprising an actuator register configured to indicate a position of the actuator at which at least a distal portion of the nasal implant has been moved out of the needle lumen.

### Claim 7 (depends on 6)

The system of claim 6, wherein the actuator register is a stop element preventing further movement of the actuator.

### Claim 8 (depends on 1)

The system of claim 1, wherein the nasal implant delivery tool further includes an indicator configured to provide a signal that the nasal implant has been moved out the needle lumen.

### Claim 9 (depends on 1)

The system of claim 1, wherein the nasal implant further comprises a strain relief section at a proximal end of the nasal implant.

### Claim 10 (depends on 1)

The system of claim 1, wherein the nasal implant includes a bioabsorbable material and a non-bioabsorbable material.

### Claim 11

A system comprising:
a nasal implant delivery tool, the nasal implant delivery tool comprising:
a handle;
a needle extending distally from the handle, wherein the needle has a needle lumen,
a loading chamber communicating with the needle lumen, and
an actuator configured to move a nasal implant along the needle lumen and out of an opening at a distal end of the needle; and
a nasal implant having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end,
wherein the nasal implant includes a first arm and a second arm at the distal end of the nasal implant,
wherein the first arm and the second arm have (i) a contracted configuration in which the first arm and the second arm are contracted toward the central longitudinal axis and (ii) an expanded configuration in which the first arm and the second arm extend away from the central longitudinal axis by a greater extent than when the first arm and the second arm are in the contracted configuration,
wherein the first arm and the second arm are biased toward the expanded configuration, and
wherein the loading chamber of the nasal implant delivery tool is configured to:
receive the nasal implant into the nasal implant delivery tool, and
transition the nasal implant from the expanded configuration to the contracted configuration as the nasal implant moves through the loading chamber and into the needle lumen,
wherein the loading chamber comprises a first lateral wall and a second lateral wall,
wherein, along a distal direction, a distance between the first lateral wall and the second lateral wall of the loading chamber narrows toward the central longitudinal axis,
wherein the first arm engages the first lateral wall and the second arm engages the second lateral wall responsive to the nasal implant moving through the loading chamber and into the needle lumen,
wherein the loading chamber further comprises a floor extending between the first lateral wall and the second lateral wall,
wherein the first lateral wall, the second lateral wall, a proximal wall, and a distal wall define an aperture of the loading chamber that opposes the floor,
wherein the loading chamber further comprises a trough in the floor, and
wherein the trough is configured to receive and guide the actuator through the loading chamber the proximal wall and the distal wall of the loading chamber each comprise an aperture through which the actuator is configured to pass.

### Claim 12

A system comprising:
a nasal implant delivery tool, the nasal implant delivery tool comprising:
a handle;
a needle extending distally from the handle, wherein the needle has a needle lumen,
a loading chamber comprising a proximal wall and a distal wall communicating with the needle lumen, and
an actuator configured to move a nasal implant along the needle lumen and out of an opening at a distal end of the needle; and
a nasal implant having a proximal end, a distal end, and a central longitudinal axis extending between the proximal end and the distal end,
wherein the nasal implant includes a first arm and a second arm at the distal end of the nasal implant,
wherein the first arm and the second arm have (i) a contracted configuration in which the first arm and the second arm are contracted toward the central longitudinal axis and (ii) an expanded configuration in which the first arm and the second arm extend away from the central longitudinal axis by a greater extent than when the first arm and the second arm are in the contracted configuration,
wherein the first arm and the second arm are biased toward the expanded configuration,
wherein the loading chamber of the nasal implant delivery tool is configured to:
receive the nasal implant into the nasal implant delivery tool, and
transition the nasal implant from the expanded configuration to the contracted configuration as the nasal implant moves through the loading chamber and into the needle lumen, the proximal wall and the distal wall of the loading chamber each comprise an aperture through which the actuator is configured to pass and
wherein the nasal implant further comprises a central portion disposed between the proximal end of the nasal implant and the distal end of the nasal implant, the central portion having a flexural rigidity of 50-130 N-mm2.

### Claim 13 (depends on 12)

The system of claim 12, wherein the loading chamber comprises a first lateral wall and a second lateral wall,
wherein, along a distal direction, a distance between the first lateral wall and the second lateral wall of the loading chamber narrows toward the central longitudinal axis.

### Claim 14 (depends on 13)

The system of claim 13, wherein the first arm engages the first lateral wall and the second arm engages the second lateral wall responsive to the nasal implant moving through the loading chamber and into the needle lumen.

### Claim 15 (depends on 14)

The system of claim 14, wherein the first lateral wall and the second lateral wall define an ovoid end of the loading chamber.

### Claim 16 (depends on 14)

The system of claim 14, wherein the loading chamber further comprises a floor extending between the first lateral wall and the second lateral wall,
wherein the first lateral wall, the second lateral wall, the proximal wall, and the distal wall define an aperture of the loading chamber that opposes the floor.

### Claim 17 (depends on 16)

The system of claim 16, wherein the aperture of the loading chamber comprises a proximal section, a distal section, and a shaping chamber section between the proximal section and the distal section, and
wherein the first lateral wall and the second lateral wall narrows toward the central longitudinal axis at the shaping chamber section,
wherein a distance between the first lateral wall and the second lateral wall is greater at the proximal section than the shaping chamber section, and
wherein a distance between the first lateral wall and the second lateral wall is greater at the distal section than the shaping chamber section.

### Claim 18 (depends on 17)

The system of claim 17, wherein a distance between the first lateral wall and the second lateral wall is greater than a diameter of the nasal implant at the proximal section.

### Claim 19 (depends on 17)

The system of claim 17, wherein a distance between the first lateral wall and the second lateral wall is greater than a diameter of the nasal implant at the distal section.