# US 12,178,722 B2 · Trial insert assembly

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- Number: US 12,178,722 B2
- Document ID: US12178722B2
- Status: Granted
- Kind: B2
- Application number: 17/304,058
- Filed: 2021-06-14
- Published: 2021-09-30
- Granted: 2024-12-31
- Earliest claimed: 2018-12-13
- Assignees: Paragon 28, Inc.
- Applicants: Paragon 28, Inc.
- Inventors: Mark Ray Dalton; Randy Allard
- Web page: https://patentgrep.com/patent/US12178722B2

## CPC

- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61F 2/4684: {Trial or dummy prostheses}
- A61F 2/4202: {for ankles}
- A61F 2002/30537: {adjustable}
- A61F 2002/3055: {for adjusting length}
- A61F 2002/30553: {for adjusting a position by translation along an axis}
- A61F 2002/30617: {Visible markings for adjusting, locating or measuring}
- A61F 2002/4625: {with relative movement between parts of the instrument during use}
- A61F 2002/4627: {with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument}
- A61F 2002/4658: {for measuring dimensions, e.g. length}
- 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)

## Abstract

A trial insert having a first member having an engagement channel extending from a bottom surface towards a top surface and along a first direction that extends from a first end to a second end. The trial insert has a second member having an engagement member extending away from a top surface and along a second direction that extends from a first end to a second end, where the engagement member is received within the engagement channel, and where the first member is translatable relative to the second member along a longitudinal axis of the trial insert.

## Claims

### Claim 1

A trial insert comprising:
a first member comprising:
an engagement channel extending from a bottom surface towards a top surface and along a first direction that extends from a first end to a second end;
at least one transverse bore extending into the first member from at least one of a first side and a second side of the first member; and
at least one front opening; and
wherein the engagement channel comprises:
a plurality of locking grooves recessed into the engagement channel, and wherein at least a portion of the plurality of locking grooves intersects with the at least one transverse bore of the first member; and
a second member comprising:
an engagement member extending away from a top surface and along a second direction that extends from a first end to a second end, wherein said engagement member is received within the engagement channel;
at least one transverse bore extending into the second member from at least one of a first side and a second side of the second member; and
wherein the first member is translatable relative to the second member along a longitudinal axis of the trial insert.

### Claim 2 (depends on 1)

The trial insert of claim 1, further comprising:
a lock screw, said lock screw comprising:
a shaft;
a head positioned at a first end of the shaft; and
a foot positioned at a second end of the shaft and said foot positioned perpendicular to the shaft;
wherein the second member further comprises:
a screw bore extending through the second member along the second direction; and
a second member bore extending from the engagement member towards the bottom surface;
wherein the screw bore intersects with the second member bore; and
wherein the shaft extends through the screw bore and into the second member bore and the foot is positioned within the second member bore.

### Claim 3 (depends on 2)

The trial insert of claim 2, wherein the foot rotatably engages a locking groove of the plurality of locking grooves.

### Claim 4 (depends on 3)

The trial insert of claim 3, wherein the head comprises:
an indicator positioned on the head, and wherein the indicator extends in a direction aligned with the foot.

### Claim 5 (depends on 1)

The trial insert of claim 1, further comprising:
a shim comprising:
an engagement member extending away from a top surface of the shim; and
an engagement channel extending from a bottom surface of the shim towards the top surface;
wherein the top surface of the shim engages the first member, wherein the bottom surface of the shim engages the second member, wherein the engagement member of the second member movably couples with the engagement channel of the shim, and wherein the engagement member of the shim movably couples with the engagement channel of the first member.

### Claim 6 (depends on 5)

The trial insert of claim 5, wherein the shim comprises:
a plurality of locking openings extending through the shim.

### Claim 7 (depends on 6)

The trial insert of claim 6, wherein at least one of the plurality of locking openings aligns with at least one of the plurality of locking grooves of the first member, and
wherein at least a portion of the foot is received within the at least one locking opening and the at least one locking groove.

### Claim 8 (depends on 7)

The trial insert of claim 7, wherein the shim further comprises:
a transverse hole recessed into a bottom surface of the shim, and
wherein the transverse hole aligns with a locking opening of the plurality of locking openings.

### Claim 9 (depends on 1)

The trial insert of claim 1, wherein the first member further comprises:
a first bone trial connector positioned on the top surface of the first member.

### Claim 10 (depends on 9)

The trial insert of claim 9, wherein the first bone trial connector includes:
a top surface; and
a bore, wherein the bore is recessed into the top surface of the first member.

### Claim 11 (depends on 9)

The trial insert of claim 9, wherein the second member further comprises:
a second bone trial connector positioned on a bottom surface of the second member.

### Claim 12

A trial insert comprising:
a first member comprising:
an engagement channel extending from a bottom surface towards a top surface and along a first direction that extends from a first end to a second end;
at least one transverse bore extending into the first member from at least one of a first side and a second side of the first member:
at least one front opening; and
a first bone trial connector positioned on the top surface of the first member, wherein the first bone trial connector comprises:
a first male dovetail positioned towards the first side of the first member;
a second male dovetail positioned towards the second side of the first member; and
a third male dovetail;
wherein the first male dovetail and the second male dovetail extend from the third male dovetail towards the first end; and
a second member comprising:
an engagement member extending away from a top surface and along a second direction that extends from a first end to a second end, wherein said engagement member is received within the engagement channel; and
at least one transverse bore extending into the second member from at least one of a first side and a second side of the second member; and
wherein the first member is translatable relative to the second member along a longitudinal axis of the trial insert.