IP Library › Granted Patent US 12,678,158
Granted Patent B2
US 12,678,158 · App. 18/131,856 · Granted Jul 14, 2026

Bone staple system

Inventors: Justin Bushko (Clearwater, FL); Giuseppe Lombardo (Trinity, FL); Daniel Riveros (Redington Shores, FL)
Assignee: Concise Engineering, Inc.
A61B17/0642A61B17/10A61B2017/0046A61B2017/00477A61B17/064A61B17/0644A61B2017/0645A61B2017/0646A61B17/068A61B17/0682A61B2017/07214A61B2017/564
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Quick Facts
Patent No.
US 12,678,158
App. No.
18/131,856
Filed
Apr 6, 2023
Granted
Jul 14, 2026
Kind
B2
Art Unit
3775
USPC
606/75
Abstract

A bone staple system configured to secure one or more bone segments and related methods is provided.

Claims (52)

1 . A bone staple system, comprising:

an inserter assembly configured to deliver a staple into a fixation site, the inserter assembly having:

a housing including a leading end, a trailing end opposite the leading end along a longitudinal axis;

an end effector that is moveable along the longitudinal axis relative to the housing between a first position and a second position;

a fulcrum fixed to the housing and that engages the end effector, wherein the fulcrum and the end effector are configured to hold the staple;

a cam assembly coupled to the end effector, the cam assembly including cam members fixedly connected to one another, wherein at least two cam members are positioned eccentrically; and

an actuator coupled to the cam assembly;

wherein actuation of the actuator moves the end effector between the first position and the second position.

2 . The bone staple system of claim 1 , further comprising a drill guide assembly configured to guide one or more instruments for preparation of a fixation site for two adjacent bone segments, the drill guide assembly having a handle, and a plurality of interchangeable drill heads, each of which are configured to be removably coupled to the handle.

3 . The bone staple system of claim 2 , wherein the handle includes a latching member configured to removably couple the handle to the drill head.

4 . The bone staple system of claim 3 , wherein the latching member is configured to engage a notch on the drill head.

5 . The bone staple system of claim 2 , wherein the drill head includes a pair of guide members configured to receive a drill bit for drilling a pair of holes.

6 . The bone staple system of claim 2 , wherein the drill head includes a pair of guide members configured to receive a locating pin.

7 . The bone staple system of claim 2 , wherein the drill head includes a pair of guide members arranged a distance apart, the distance being based on a size of a staple.

8 . The bone staple system of claim 1 , further comprising a staple having a bridge and a pair of legs extending from the bridge.

9 . The bone staple system of claim 8 , wherein the staple is configured to transition between a first state where the legs are biased inwardly toward each other and a second state where the legs are biased away from each other relative to the first state.

10 . The bone staple system of claim 8 , wherein the fulcrum is configured to provide a biasing force capable of causing the staple to move to a flexed state when the end effector is in the second position.

11 . The bone staple system of claim 8 , wherein the staple is adjustably secured to the inserter assembly via a pair of projections.

12 . The bone staple system of claim 1 , wherein the actuator is rotatable about a rotation axis that is perpendicular to the longitudinal axis, wherein rotation of the actuator about the rotation axis causes the end effector to move in a proximal direction along the longitudinal axis toward the trailing end of the housing.

13 . The bone staple system of claim 12 , wherein rotation of the actuator causes actuation of the cam assembly coupled to the end effector.

14 . An inserter assembly configured to deliver a staple into a fixation site, the inserter assembly comprising:

a housing including a leading end, a trailing end opposite the leading end along a longitudinal axis;

an end effector that is moveable along the longitudinal axis relative to the housing between a first position and a second position;

a pin fixed to the housing and that engages the end effector, wherein the pin and the end effector are configured to secure the staple;

a cam assembly coupled to the end effector, the cam assembly including cam members fixedly connected to one another, wherein at least two cam members are positioned eccentrically;

an actuator coupled to the cam assembly; and

wherein actuation of the actuator moves the end effector between the first position and the second position.

15 . The inserter assembly of claim 14 , the cam members including:

an upper cam member fixedly coupled to the actuator,

a central cam member extending through the end effector, and

a lower cam member rotatably secured to the housing.

16 . The inserter assembly of claim 15 , wherein the central cam member extends through a first elongated slot of the end effector.

17 . The inserter assembly of claim 15 , wherein the upper cam member has a first longitudinal axis offset from a second longitudinal axis of the central cam member.

18 . The inserter assembly of claim 15 , wherein the actuator and the cam assembly pivotably rotate about a first longitudinal axis of the upper cam member.

19 . The inserter assembly of claim 18 , wherein rotation of the actuator about the first longitudinal axis causes the central cam member to rotatably move along a first elongated slot of the end effector.

20 . The inserter assembly of claim 19 , wherein the central cam member is configured to bias an inner perimeter of the first elongated slot causing the end effector to translate laterally and outwardly from the first position to the second position.

21 . The inserter assembly of claim 14 , wherein the end effector is movable relative to the housing between the first position and the second position.

22 . The inserter assembly of claim 21 , wherein the second position is anteriorly spaced from the first position.

23 . The inserter assembly of claim 14 , wherein the pin extends through a second elongated slot of the end effector spaced from a first elongated slot of the end effector.

24 . The inserter assembly of claim 23 , wherein the pin slidably moves along the second elongated slot as the end effector moves from the first position to the second position.

25 . The inserter assembly of claim 24 , wherein the pin is configured to bias the staple secured to the inserter assembly when the end effector is in the second position.

26 . The inserter assembly of claim 14 , wherein the end effector includes a pair of projections for adjustably securing the staple to the inserter assembly.

27 . The inserter assembly of claim 14 , wherein the actuator is rotatable about a rotation axis that is perpendicular to the longitudinal axis, wherein rotation of the actuator about the rotation axis causes the end effector to move in a proximal direction along the longitudinal axis toward the trailing end of the housing.

28 . The inserter assembly of claim 27 , wherein rotation of the actuator causes actuation of the cam assembly coupled to the end effector.

29 . A bone staple system, comprising:

an inserter assembly configured to deliver a staple into a fixation site, the inserter assembly having:

a housing including a leading end, a trailing end opposite the leading end along a longitudinal axis;

an end effector that is moveable along the longitudinal axis relative to the housing between a first position and a second position;

a fulcrum fixed to the housing and that engages the end effector, wherein the fulcrum and the end effector are configured to hold the staple;

a cam assembly coupled to the end effector; and

an actuator coupled to the cam assembly;

wherein actuation of the actuator moves the end effector between the first position and the second position, wherein the end effector in the second position is configured to flex the staple such that a distance between legs of the staple remains constant for insertion.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 17, 2023
From: BUSHKO, JUSTIN; LOMBARDO, GIUSEPPE; RIVEROS, DANIEL
To: CONCISE ENGINEERING, INC.
Reel/Frame 063341/0268 →
Continuity (2)
Provisional Application 63337578 · May 2, 2022
Related Publication 20230346369A1 · Nov 2, 2023
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