Systems for treating and/or preventing fractures and related devices and methods

Patent metadata

Field	Value
Publication number	US-12471972-B2
Application number	US-202017636454-A
Country	US
Kind code	B2
Filing date	Aug 27, 2020
Priority date	Aug 28, 2019
Publication date	Nov 18, 2025
Grant date	Nov 18, 2025

Abstract

Systems for treating and/or preventing fractures include at least one needle sized and configured to be placed into target bone and at least one implantable pin configured to be releasably held in a first needle of the at least one needle. The systems also include at least one delivery device of injectable material configured to couple to the first needle while the first implantable pin is held in the first needle whereby the at least one delivery device and a respective needle cooperate to serially provide an external column of the injectable material about the at least one implantable pin.

First claim

That which is claimed:

1 . A medical implant system for structurally augmenting bone or treating a fracture, comprising:
at least one needle sized and configured to be placed into target bone; at least one implantable pin, a first implantable pin of the at least one implantable pin configured to be releasably held in a first needle of the at least one needle; and at least one delivery device comprising injectable material configured to couple to the first needle while the first implantable pin is held in the first needle whereby the at least one delivery device and the first needle cooperate to provide an external column of the injectable material about the first implantable pin.

2 . The system of claim 1 , wherein the at least one implantable pin has one or more of:
(a) a solid body with a maximal cross-sectional area in a range of 1-5 mm; (b) a maximal outer diameter of 5 mm; (c) at least one spirally extending rib on an outer surface thereof; (d) an open longitudinally extending channel in fluid communication with a plurality of spaced apart fluid ports positioned in a spiral pattern along a length of the at least one implantable pin; (e) a body with an outer diameter that is in a range of about a 7 gauge-9 gauge size; or (f) a curved body with a radius of curvature extending over a length dimension with the curvature provided by the radius of curvature extending at least along a middle segment thereof.

3 . The system of claim 1 , further comprising a stylet sized and configured to slidably and releasably couple to the at least one needle with the stylet surrounding at least part of the needle, wherein the stylet is configured with rigidity sufficient to form a bone channel in cancellous bone to thereby place the at least one needle into the target bone directly using the stylet without reaming a bone channel with a drill.

4 . The system of claim 1 , wherein the injectable material is configured to solidify in vivo to define a solid external column of material that is coupled to and extends over at least a major portion of a length of the first implantable pin as the external column of the injectable material about the first implantable pin.

5 . The system of claim 1 , wherein the first needle is curvilinear, and wherein the first implantable pin is configured so that when implanted it has a radius of curvature over a length dimension including at least a middle segment thereof that defines a curved elongate body.

6 . The system of claim 1 , further comprising a second implantable pin configured to serially releasably couple to the first needle of the at least one needle in place of the first implantable pin or couple to a second needle of the at least one needle to be releasably held in the first needle or the second needle and with the first needle or the second needle coupled to the at least one delivery device comprising injectable material whereby the at least one delivery device and the first needle or the second needle cooperate therewith to provide an external column of the injectable material about the second implantable pin, and wherein the external column of injectable material of the first implantable pin is configured to solidify in vivo to define a solidified external column of material about the first implantable pin and the external column of injectable material of the second implantable pin is configured to solidify in vivo to define a solidified external column of material about the second implantable pin.

7 . The system of claim 6 , wherein, in position, the first implantable pin with the solidified external column of material has opposing first and second end portions and is configured to curve outward in a direction toward a proximal end of a femur as the target bone and, wherein the second implantable pin with the solidified external column of material has opposing first and second end portions and curves outward in a direction opposite the first implantable pin.

8 . The system of claim 7 , wherein, the first end portion of the first implantable pin is coupled to the first end portion of the second implantable pin and the second end portion of the first implantable pin is coupled to the second end portion of the second implantable pin whereby the first implantable pin with the external column of injectable material and the second implantable pin with the external column of injectable material are interlocked and configured to provide load bearing beams adapted to form an internal truss within the target bone.

9 . The system of claim 1 , further comprising a second implantable pin configured to serially releasably couple to the first needle of the at least one needle in place of the first implantable pin or couple to a second needle of the at least one needle to cooperate with the at least one delivery device comprising injectable material to provide an external column of the injectable material about the second implantable pin, wherein the first implantable pin with the external column of injectable material and the second implantable pin with the external column of injectable material are configured to laterally extend over an entire lateral extent or substantially the entire lateral extent of a proximal end portion of a femur as the target bone between a femoral head and greater trochanter to thereby define load bearing beams that are adapted to form an internal truss within the proximal end portion of the femur.

10 . The system of claim 9 , further comprising a third implantable pin with an external column of injectable material, wherein the third implantable pin is configured to extend in a different plane and across a medial segment of one or both of the first implantable pin with the external column of injectable material and the second implantable pin with the external column of injectable material and is adapted to be positioned from a location under a lesser trochanter to a location proximate the proximal end of the femur between a femoral head and greater trochanter.

11 . The system of claim 1 , wherein the needle is cylindrical with an open longitudinally extending channel and a wall surrounding the open channel with the open channel sized to receive the first implantable pin.

12 . The system of claim 11 , wherein the needle comprises at least one fluid delivery port extending through the wall.

13 . The system of claim 1 , wherein the at least one implantable pin is configured to have a straight linear shape outside the first needle when not exposed to compressive forces and is configured to have a curvilinear shape when in the first needle and when implanted with a curvature of the curvilinear shape extending along at least a middle segment thereof.

14 . The system of claim 1 , wherein the first implantable pin has a maximal lateral extent in a range of about 1 mm to about 4 mm and has a longitudinally extending center axis and, is configured so that, at least when implanted, it also has a radius of curvature that corresponds to a curvature of a trabecular bone load path of a normal trabecular bone as the target bone.

15 . The system of claim 1 , wherein the first implantable pin has a solid body and comprises at least one rib that extends over at least a major portion of a length thereof, and wherein a lateral cross-sectional shape of the first implantable pin has a perimeter with a plurality of valleys and projections.

16 . The system of claim 15 , wherein the at least one rib comprises at least one spirally extending rib.

17 . The system of claim 15 , wherein the at least one rib comprises at least one longitudin

Assignees

• Univ Wake Forest Health Sciences

Inventors

• Brown Philip Jayson
• Roller Brandon Lee

Classifications

• A61B17/742 Primary

  having one or more longitudinal elements oriented along or parallel to the axis of the neck · CPC title

• A61F2002/2825

  Femur · CPC title

• A61B17/7258

  with laterally expanding parts, e.g. for gripping the bone · CPC title

• A61F2/28

  Bones · CPC title

• A61B17/86

  Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)} · CPC title