# US 11,998,191 B2 · Bone implant with means for multi directional force and means of insertion

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- Number: US 11,998,191 B2
- Document ID: US11998191B2
- Status: Granted
- Kind: B2
- Application number: 17/700,338
- Filed: 2022-03-21
- Published: 2022-06-30
- Granted: 2024-06-04
- Earliest claimed: 2014-07-10
- Assignees: Crossroads Extremity Systems, LLC
- Applicants: Crossroads Extremity Systems, LLC
- Inventors: Vernon R. Hartdegen; Michael Chad Hollis; Glen Coleman; Daniel Sayger
- Web page: https://patentgrep.com/patent/US11998191B2

## CPC

- A61B 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone}
- A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- A61B 17/1728: {for holes for bone plates or plate screws}
- A61B 17/1775: {for the foot or ankle}
- A61B 17/8004: {with means for distracting or compressing the bone or bones}
- A61B 17/8019: {where the means are a separate tool rather than being part of the plate}
- A61B 17/8052: {immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded}
- A61B 17/8061: {specially adapted for particular bones (A61B17/70 and A61B17/74 take precedence)}
- A61B 17/808: {Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms}
- A61B 17/809: {with bone-penetrating elements, e.g. blades or prongs (bone staples A61B17/0642; intramedullary nails with a plate at an end A61B17/7233)}
- A61B 17/846: {Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface (A61B17/72, A61B17/86 take precedence)}
- A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61B 17/8863: {Apparatus for shaping or cutting osteosynthesis equipment by medical personnel}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0645: {being elastically deformed for insertion}
- A61F 2/0811: {Fixation devices for tendons or ligaments}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

An assembly used in osteosynthesis comprising a delivery instrument in combination with an implant wherein the delivery instrument releasably holds the implant in a first configuration prior to attachment of the implant to bone. The delivery instrument allows the implant to be affixed to bone before the implant is released from the instrument. And the instrument may comprise guide means for drills, depth gauges, screws, pins, pegs, blades and or drivers which are used or implanted when the implant is releasably attached to the instrument. After the implant is affixed to bone and released from the delivery instrument, the implant assumes at least a second configuration which provides compression and or distraction and or control of spatial orientation.

## Claims

### Claim 1

A tissue fixation system comprising:
an implant, wherein the implant is movable between a first configuration and a second configuration; and
an inserter having first and second arms connectable to the implant, the inserter including:
a body having a proximal end and a distal end, and a length from the proximal end to the distal end, the body defining a width along a first direction, and the body including first and second outermost surfaces that extend from the proximal end to the distal end along the length, wherein the first and second outermost surfaces are opposite each other along a second direction so as to define a thickness of the body, the second direction is perpendicular to the first direction, and the width is less than the length and greater than the thickness;
a rod that is elongate along a central axis that is perpendicular to each of the first direction and the second direction, wherein the rod is threadedly mated with the body, and the first and second arms are spaced from each other along the first direction,
open void space that extends entirely through the body from the first outermost surface to the second outermost surface along the second direction, wherein the void space defines a total length along the central axis that is greater than half the length of the body;
a knob that is rotatably coupled to the rod such that rotation of the knob relative to the body in a direction of rotation about the central axis causes the implant to move to the first configuration when the inserter is connected to the implant,
wherein the implant is configured to be fully seatable in a final position against a tissue when the implant is in the first configuration;
wherein the inserter is configured to disconnect from the implant when the implant is fully seated in the final position, such that the implant moves from the first configuration to the second configuration, whereby the implant is configured to apply a compressive force to the tissue when the implant is in the second configuration.

### Claim 2 (depends on 1)

The tissue fixation system of claim 1, wherein the open void space defines an internal window of the body, and the knob is disposed in the internal window.

### Claim 3 (depends on 1)

The tissue fixation system of claim 1, wherein the body defines a width along a width direction that is perpendicular to the central axis and a thickness along a thickness direction that is perpendicular to each of the width direction and the central axis, the width is greater than the thickness, and the open void space extends through the body along the thickness direction.

### Claim 4 (depends on 3)

The tissue fixation system of claim 3, wherein the open void space is defined by first and second windows that have respective widths along the width direction, and the width of the first window is more than double the width of the second window.

### Claim 5 (depends on 4)

The tissue fixation system of claim 4, wherein the rod extends in a distal direction toward the implant, and the second window is distal of the first window.

### Claim 6 (depends on 3)

The tissue fixation system of claim 3, wherein the implant comprises a bridge, first and second bone engaging members that are opposite each other along the width direction when the inserter is coupled to the implant, and first and second tabs that extend out from the bridge and outward with respect to the first and second bone engaging members, respectively.

### Claim 7 (depends on 6)

The tissue fixation system of claim 6, wherein the first and second arms are pivotally attached to the body and configured to engage lower surfaces of the first and second tabs, respectively.

### Claim 8 (depends on 7)

The tissue fixation system of claim 7, wherein the bridge defines an upper surface and a lower surface opposite the upper surface, and the lower surface of the bridge is lower than the lower surfaces of the tabs.

### Claim 9 (depends on 6)

The tissue fixation system of claim 6, wherein the bone engaging members are spaced closer together when the implant is in the second configuration compared to when the implant is in the first configuration.

### Claim 10 (depends on 1)

The tissue fixation system of claim 1, wherein the body comprises a distal slot that receives the implant while the implant is in the first configuration.

### Claim 11 (depends on 1)

The tissue fixation system of claim 1, wherein the knob translates along the central axis as the knob is rotated.

### Claim 12

A tissue fixation system comprising:
an implant, wherein the implant is movable between a first configuration and a second configuration; and
an inserter connectable to the implant, the inserter comprising a body, and first and second arms coupled to the body and pivotable relative to the body between an open position and a closed position, wherein the first and second arms are spring-biased toward the closed position;
wherein when the first and second arms are in the open position, the arms are configured to receive the implant, and moving the first and second arms to the closed position causes the arms to connect to the received implant, such that the inserter is actuatable to move the implant from the first configuration to the second configuration, and the implant is configured to be fully seatable in a final position against a tissue when the implant is in the first configuration,
wherein the first and second arms are configured to move from the closed position to the open position, which causes the first and second arms to disconnect from the implant when the implant is in the final position, such that the implant moves from the first configuration to the second configuration, whereby the implant is configured to apply a compressive force to the tissue when the implant is in the second configuration, and
wherein the inserter further comprises an interlock component that is positionable between the first and second arms so as to prevent the arms from moving from the open configuration to the closed configuration.

### Claim 13 (depends on 12)

The tissue fixation system of claim 12, wherein each of the first and second arms define spring members that bear against the body.

### Claim 14 (depends on 12)

The tissue fixation system of claim 12, wherein the implant comprises a bridge, first and second bone engaging members, and first and second tabs that extend laterally out from the bridge and laterally outward with respect to the first and second bone engaging members, respectively.

### Claim 15 (depends on 14)

The tissue fixation system of claim 14, wherein the first and second arms define first and second hooks that are configured to engage lower surfaces of the first and second tabs, respectively.

### Claim 16 (depends on 15)

The tissue fixation system of claim 15, wherein the bridge defines an upper surface and a lower surface opposite the upper surface, and the lower surface of the bridge is lower than the lower surfaces of the tabs.

### Claim 17 (depends on 12)

The tissue fixation system of claim 12, wherein the inserter comprises a rod that is threadedly mated with the body such that rotation of the rod in a direction of rotation causes the rod to drive a slider against the implant.

### Claim 18 (depends on 17)

The tissue fixation system of claim 17, wherein the rod is coupled to a knob that is disposed in an internal window of the body.
