Granted Patent B2

US 12,514,709 · App. 17/576,924 · Granted Jan 6, 2026

Inventor: Thomas Holton (Winona Lake, IN)

Assignee: MEDARTIS AG

A61F2/30749A61F2/4225A61F2/4606A61F2002/30166A61F2002/30405A61F2002/30622A61F2002/30777

Abstract

Claims (68)

1 . A system for deploying a fixation member into a bone fastener having an aperture, the system comprising:

a guide comprising:

a body having a proximal end and a distal end;

a guide member coupled to the body near the proximal end, wherein the guide member is configured to guide placement of the fixation member to secure the bone fastener; and

an engagement member coupled to the body near the distal end, wherein the engagement member is configured to engage the bone fastener such that the guide member is rotatable, relative to the bone fastener, about an engagement axis to a plurality of relative orientations; and

wherein the engagement member is configured to secure the guide member at any of the plurality of relative orientations about the engagement axis,

the engagement member comprising:

a shaft having a proximal end and a distal end that engages the by ne fastener;

a collar connected to the body, the collar having aperture through the collar, the aperture sized to receive the shaft,

a protrusion coupled to the shaft towards the proximal end, and

wherein the protrusion presses against at least a portion of the collar when the shaft engages the bone fastener

an inserter configured to couple to the bone fastener, the inserter having a proximal end having a coupling member comprising a socket that extends distally into a superior surface of the coupling member; and

wherein the shaft comprises external threads near the distal end of the shaft configured to engage internal threads of the socket, the socket having a depth that accepts distal advancement of the shaft until the protrusion presses against the collar,

wherein a superior surface of the coupling member and an inferior surface of the collar form an engagement interface configured to constrain rotational movement of the inserter and the collar about the engagement axis; and

wherein the engagement interface comprises an interlocking coupling comprising a plurality of both teeth and valleys on each of the superior surface of the coupling member and the inferior surface of the collar, the teeth and valleys of each of the superior surface of the coupling member and the inferior surface of the collar intermesh when the coupling member and the collar abut.

2 . The system of claim 1 , further comprising the bone fastener, wherein the bone fastener comprises:

a first leg having a leading end and a trailing end;

a second leg having a leading end and a trailing end; and

a body connected to the first leg and to the second leg, the body defining the aperture.

3 . The system of claim 1 , wherein the engagement member comprises a lock mechanism comprising:

a handle having a shoulder;

a shaft connected to the handle, the shaft configured to engage a socket; and

wherein the shoulder pinches the body as the shaft advances distally within the socket to secure the guide member at one of the plurality of relative orientations about the engagement axis.

4 . The system of claim 3 , wherein the shaft comprises threads near a distal end of the shaft and the socket comprises a threaded socket configured to engage threads of the shaft, the guide comprising:

an inserter positioned between the engagement member and the bone fastener, the inserter comprising the threaded socket; and

wherein the shoulder pinches the body against the inserter.

5 . The system of claim 1 , wherein the engagement member comprises a pin extending from an inferior surface of the collar, the pin configured to engage a cavity of an inserter connected to the bone fastener.

6 . The system of claim 1 , wherein the engagement member comprises a stop configured to limit the plurality of relative orientations about the engagement axis to a range of angles such that deployment of the fixation member will enter the aperture.

7 . The system of claim 1 , wherein the engagement member comprises a feature configured to limit a range of motion of the guide to a range of relative orientations about the engagement axis, the feature comprising one or more pins configured to contact a surface of an inserter or bone fastener.

8 . A system for deploying a fixation member for a bone fastener, the system comprising:

a bone fastener comprising:

a first leg having a leading end and a trailing end;

a second leg having a leading end and a trailing end;

a body connected to the first leg and to the second leg; and

an aperture through the body, the aperture having an aperture length and an aperture width, the aperture length greater than the aperture width; and

a guide mountable to the bone fastener in a rotating relationship, the guide configured to securely position a fixation member at any of a plurality of relative orientations, in alignment with the aperture about an engagement axis,

wherein the guide comprises:

a cross fixation insertion axis transverse to the engagement axis;

a guide member coupled near a proximal end of the guide the guide member comprising:

a passage through the guide member that aligns with the cross fixation insertion axis;

a first sleeve coaxial with the cross fixation insertion axis and having a cross sectional diameter less than a cross sectional diameter of the passage;

a second sleeve coaxial with the cross fixation insertion axis and having a cross sectional diameter less than a cross sectional diameter of the first sleeve; and

a third sleeve coaxial with the cross fixation insertion axis and having a cross sectional diameter less than a cross sectional diameter of the second sleeve.

9 . The system of claim 8 , further comprising an inserter configured to connect to both the bone fastener and the guide and wherein: the first sleeve is sized to accept the fixation member and a driver coupled to the fixation member; the second sleeve is sized to accept a drill bit; and the third sleeve is sized to accept a temporary fastener.

10 . The system of claim 8 , wherein the guide member comprises a pivot member configured to orient the cross fixation insertion axis from a perpendicular orientation in relation to the engagement axis to one of a superior orientation and an inferior orientation.

11 . The system of claim 10 , wherein the pivot member comprises a lock mechanism configured to secure the pivot member to retain an orientation of the cross fixation insertion axis in relation to the engagement axis.

12 . A method of stabilizing a bone fastener that traverses a first bone portion and a second abutting bone portion, the method comprising:

deploying a bone fastener within a first bone portion and a second abutting bone portion, the bone fastener having:

an insertion axis;

a body having an aperture having an aperture length and an aperture width, the aperture length being greater than the aperture width;

a first leg connected to the body; and

a second leg connected to the body;

coupling a guide to the bone fastener, the guide having:

a body having a proximal end and a distal end;

a guide member coupled to the body near the proximal end, the guide member configured to guide placement of a fixation member to secure the bone fastener; and

an engagement member coupled to the body near the distal end, the engagement member engageable with the bone fastener about an engagement axis at a plurality of relative orientations, the engagement member configured to secure the guide member at one of the plurality of relative orientations about the engagement axis;

rotating the guide about the engagement axis to a desired orientation;

securing the guide member at the desired orientation; and

deploying the fixation member to stabilize the bone fastener;

wherein deploying the fixation member further comprises:

confirming an orientation of a cross fixation insertion axis coaxial with the guide member by way of a temporary fastener passed through a pin sleeve positioned within a drill sleeve which is positioned within a fixation member sleeve which is positioned within a passage of the guide member of the guide;

drilling a hole into one of the first bone portion and the second abutting bone portion by way of a bit within the drill sleeve; and

deploying the fixation member into the hole by way of a driver connected to the fixation member within the fixation member sleeve.

13 . The method of claim 12 wherein securing the guide member further comprises:

engaging a locking mechanism of the engagement member to secure the guide member at the desired orientation;

disengaging the locking mechanism of the engagement member of the guide;

rotating the guide to a new orientation about the engagement axis; and

reengaging the locking mechanism of the engagement member of the guide.

Assignments (2)

Continuity (1)

References Cited (34)