Devices, systems, and methods for bone repair or implant fixation
The devices, systems, and methods herein described provide uniform biomaterial delivery to produce robust adhesion between an implant (e.g., an implantable screw) and a bone tissue. Furthermore, the devices, systems, and methods of the disclosure overcome challenges associated with the repair of weak or deficient bone and augmentation using injected biomaterials.
1 . A device comprising a unitary body comprising from a proximal end to a distal end: a proximal region, a central region, and a distal region, wherein the central region joins the proximal region to the distal region, and wherein:
a) the device comprises an internal channel extending longitudinally through the proximal, central, and distal regions;
b) the proximal region comprises an opening to the internal channel and a plurality of circumferentially disposed and compressible wings;
c) the central region comprises an internal or external thread and a compressible body configured to radially compress during insertion and to return to an uncompressed state upon removal of the radial pressure; and
d) the distal region comprises an opening to the internal channel and internal threads.
2 . The device of claim 1 , wherein:
i) the proximal region comprises an inner diameter of from about 1 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm;
ii) the central region comprises an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 1.25 mm to about 25 mm;
iii) the distal region comprises an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; or
iv) wherein the proximal region, the central region, and the distal region comprise an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 1.25 mm to about 25 mm.
3 . The device of claim 2 , wherein the outer diameter of the proximal and/or distal regions is smaller than the outer diameter of the central region.
4 . The device of claim 1 , wherein the device comprises:
A) a length of from about 9 mm to about 110 mm;
B) 1 to 70 longitudinal grooves; and/or
C) a plurality of longitudinal segments.
5 . The device of claim 1 , wherein the internal or external thread of the central region is broken by a slit.
6 . The device of claim 5 , wherein the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit.
7 . The device of claim 4 , wherein for B), the longitudinal grooves:
a) comprise a depth of from about 0.15 mm to about 2.5 mm; and/or
b) extend from a proximal end of the central region to a distal end of the central region.
8 . The device of claim 4 , wherein for C):
a) the proximal region, central region, and/or distal region comprises the plurality of segments;
b) the plurality of segments extends from the proximal end, through the central region, to the distal end;
c) the plurality of segments comprises a polygonal, circular, triangular, elliptical, cylindrical, or amorphous shape;
d) the device comprises from 2 to 10 segments;
e) each of the segments are the same size;
f) each of the segments is separated by at least one opening, wherein the opening has a maximum width of about 0.1 mm to about 50 mm;
g) each of the segments comprises a length of about 9 mm to about 110 mm; or
h) each of the segments comprises a width of about 0.1 mm to about 50 mm.
9 . The device of claim 8 :
i) wherein for a), the plurality of segments comprises longitudinal segments; or
ii) wherein for c), the plurality of segments comprises a rectangular shape.
10 . The device of claim 1 , wherein the proximal region comprises:
A) a length of from about 2 mm to about 30 mm;
B) a wall thickness of from about 0.15 mm to about 3.0 mm;
C) an internal or external protrusion; or
D) an internal or external thread.
11 . The device of claim 10 , wherein for B), the wall thickness of the proximal region is from about 0.3 mm to about 0.6 mm.
12 . The device of claim 10 , wherein for C):
a) the internal or external protrusion comprises one or more of a bump, a spike, a tab, a fin, a ridge, or a raised surface;
b) the internal or external protrusion extends from a proximal end to a distal end of the proximal region;
c) a plurality of internal or external protrusions extends from a proximal end to a distal end of the proximal region; or
d) the device comprises from 1 to 500 internal or external protrusions.
13 . The device of claim 10 , wherein for D), the internal or external thread:
a) comprises a thread pitch of from about 0.25 mm to about 2.5 mm;
b) is formed from protrusions, grooves, waves, or a mesh;
c) comprises a continuous thread or non-continuous thread; or
d) is broken by a slit.
14 . The device of claim 13 :
i) wherein for b), the protrusions, grooves, or waves are at from about 1 to about 180 points per 360°;
ii) wherein for c), the non-continuous thread comprises a gap, wherein the gap has a length from about 0.5 mm to about 30 mm; or
iii) wherein for d), the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit.
15 . The device of claim 1 , wherein the central region comprises:
A) a length of from about 5 mm to about 110 mm;
B) a wall thickness of from about 0.15 mm to about 2 mm;
C) an internal or external protrusion; or
D) a first section comprising the compressible body, wherein the central region further comprises a second section comprising a plurality of openings.
16 . The device of claim 15 , wherein for B), the wall thickness of the central region is from about 0.8 mm to about 0.9 mm.
17 . The device of claim 15 , wherein for C):
a) the internal or external protrusion of the central region comprises a bump, a spike, a tab, a fin, a ridge, or a raised surface;
b) the internal or external protrusion extends from a proximal end to a distal end of the central region;
c) a plurality of internal or external protrusions extends from a proximal end to a distal end of the central region: or
d) the device comprises from 1 to 500 internal or external protrusions.
18 . The device of claim 1 , wherein the internal or external thread of the central region:
a) comprises a thread pitch of from about 0.25 mm to about 2.5 mm;
b) is formed from protrusions, grooves, waves, or a mesh; or
c) comprises a continuous thread or non-continuous thread.
19 . The device of claim 18 :
i) wherein for b), the protrusions, grooves, or waves are at from about 1 to about 180 points per 360°; or
ii) wherein for c), the non-continuous thread comprises a gap, wherein the gap has a length from about 0.5 mm to about 30 mm.
20 . The device of claim 15 , wherein for D):
a) the central region comprises from a proximal end to a distal end: the first section and the second section;
b) the first section comprises a length of from about 5 mm to about 100 mm; or
c) the second section comprises a length of from about 5 mm to about 100 mm.
21 . The device of claim 1 , wherein the distal region comprises:
A) a length of from about 2 mm to about 30 mm;
B) a wall thickness of from about 0.15 mm to about 2.5 mm;
C) a distal end;
D) from 2 to 4 notches and/or elongated slits;
E) from 1 to 500 openings;
F) an internal or external protrusion;
G) an external thread; or
H) a plurality of bendable tips disposed at the proximal end and/or the distal end.
22 . The device of claim 21 :
a) wherein for B), the wall thickness of the distal region is from about 0.4 mm to about 0.5 mm;
b) wherein for D), the slits comprise a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit; or
c) wherein for E), the diameter of each opening is from about 0.01 mm to about 5 mm.
23 . The device of claim 21 , wherein for C), the distal end of the distal region comprises:
a) a blunt and/or tapered edge; or
b) from 2 to 5 milling flutes, wherein optionally the distal region comprises 3 milling flutes.
24 . The device of claim 21 , wherein for F):
a) the internal or external protrusion comprises one or more of a bump, a spike, a tab, a fin, a ridge, or a raised surface;
b) the internal or external protrusion extends from a proximal end to a distal end of the distal region;
c) a plurality of internal or external protrusions extends from a proximal end to a distal end of the distal region; or
d) the device comprises from 1 to 500 internal or external protrusions.
25 . The device of claim 21 , wherein for G), the external thread:
a) comprises a thread pitch of from about 0.25 mm to about 2.5 mm;
b) is formed from protrusions, grooves, waves, or a mesh;
c) comprises a continuous thread or non-continuous thread; or
d) is broken by a slit.
26 . The device of claim 25 :
i) wherein for b), the protrusions, grooves, or waves are at from about 1 to about 180 points per 360°;
ii) wherein for c), the non-continuous thread comprises a gap, wherein the gap has a length from about 0.5 mm to about 30 mm; or
iii) wherein for d), the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit.
27 . The device of claim 1 , wherein each of the wings comprises:
A) a rectangular, round, elliptical, triangular, jagged, or parabolic shape, comprising a length and a width;
B) a proximal end disconnected from the proximal region and configured to protrude outwardly from the proximal region; and
C) a distal end connected to the proximal region and configured to pivot the proximal end of the wing away from the proximal region.
28 . The device of claim 27 :
a) wherein each of the wings comprises a length of from about 5 mm to about 20 mm and/or a width of from 1 mm to 15 mm; and/or
b) wherein the device comprises 3 to 20 wings.
29 . The device of claim 28 , wherein for b), the device comprises 4 to 8 wings.
30 . The device of claim 29 , wherein the device comprises 8 wings.
31 . The device of claim 27 , wherein for B), the proximal end of each of the wings:
a) protrudes outwardly from the proximal region at an angle of from about 2° to 10°, and
b) is configured to reversibly deflect towards the proximal region to substantially eliminate the outward protrusion of the proximal end upon compression.
32 . The device of claim 1 , wherein the compressible body comprises a plurality of openings.
33 . The device of claim 32 , wherein the plurality of openings comprises slits or perforations.
34 . The device of claim 33 , wherein the plurality of openings comprises helical slits, segmented slits, longitudinal slits, circumferential slits, circular perforations, elliptical perforations, triangular perforations, polygonal perforations, or amorphous perforations.
35 . The device of claim 32 , wherein:
A) the openings extend into the proximal region and/or the distal region;
B) the device comprises 2 to 500 openings;
C) the openings comprise a width of from about 0.01 mm to about 20 mm and a length of from about 0.01 mm to about 20 mm;
D) the openings comprise perforations and wherein the perforations comprise a circular, elliptical, triangular, polygonal, or amorphous shape comprising a diameter of from about 0.1 mm to about 5 mm;
E) the openings comprise perforations, wherein a plurality of the perforations are connected by at least one slit; or
F) the openings comprise perforations, wherein the perforations form a mesh or mesh-like structure.
36 . The device of claim 35 , wherein for E):
a) the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit; or
b) the slit connects 2 to 100 perforations.
37 . The device of claim 35 , wherein for F), the mesh or mesh-like structure:
a) is woven, perforated, crimped, welded, molded, sintered, or 3D-printed;
b) comprises a percent porosity from about 5% to about 90%; or
c) comprises a wire gauge from 5 to 50.
38 . The device of claim 1 , wherein the internal threads of the distal region have a thread pitch of from about 0.25 mm to about 2.5 mm.
39 . The device of claim 1 , wherein the device is made from or comprises a material selected from the group consisting of stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
40 . The device of claim 1 , wherein the proximal region, the central region, and the distal region are fabricated separately and combined to form the unitary body.
41 . The device of claim 1 , wherein:
A) the proximal region comprises:
a) a length of from about 5 mm to about 10 mm; and
b) a wall thickness of from about 0.3 mm to about 0.5 mm;
c) an inner diameter of from about 1 mm to about 20 mm; and
d) an outer diameter of from about 4 mm to about 25 mm;
B) the central region comprises:
a) a length of from about 14 mm to about 26 mm;
b) a wall thickness of from about 0.8 mm to about 0.9 mm;
c) an inner diameter of from 1 mm to about 20 mm; and
d) an outer diameter of from about 1.25 mm to about 25 mm; and
C) the distal region comprises:
a) a length of from about 15 mm to about 30 mm;
b) a wall thickness of from about 0.4 mm to about 0.5 mm;
c) an inner diameter of from 1 mm to about 20 mm; and
d) an outer diameter of from about 4 mm to about 25 mm.
42 . The device of claim 41 , wherein:
A) the proximal region further comprises:
e) a first plurality of openings, wherein each of the openings of the first plurality of openings comprises:
i) a width of from about 1.5 mm to about 2 mm; and
ii) a length of from about 2 mm to about 5 mm;
f) a second plurality of openings, wherein each of the openings of the second plurality of openings comprises:
i) a width of from about 1 mm to about 1.5 mm; and
ii) a length of from about 1 mm to about 1.5 mm;
B) the central region further comprises:
e) a plurality of slits, wherein each of the plurality of slits comprises a width of about 1.4 mm;
f) an internal thread, wherein the internal thread comprises a pitch of from about 1.2 mm to about 1.3 mm; and
C) the distal region further comprises:
e) a third plurality of openings, wherein each of the openings of the third plurality of openings comprises:
i) a width of from about 1.5 mm to about 2 mm; and
ii) a length of from about 2 mm to about 5 mm;
D) each of the wings of the plurality of circumferentially disposed and compressible wings comprises a width of about 1 mm to about 2 mm;
E) the outer diameter of the proximal region is from about 4 mm to about 5 mm, and wherein the inner diameter of the proximal region is from about 3 mm to about 4 mm;
F) the outer diameter of the central region is from about 5 mm to about 6 mm, and wherein the inner diameter of the central region is from about 3 mm to about 4 mm; and
G) the outer diameter of the distal region is from about 4 mm to about 5 mm, and wherein the inner diameter of the distal region is from about 3 mm to about 4 mm.
43 . The device of claim 42 , wherein:
i) the length of the proximal region is about 7 mm;
ii) the length of the central region is from about 18 mm to about 19 mm; and
iii) the length of the distal region is from about 19 mm to about 20 mm.
44 . The device of claim 42 , wherein:
i) the length of the proximal region is from about 8 mm to about 9 mm;
ii) the length of the central region is from about 21 mm to about 22 mm; and
iii) the length of the distal region is from about 25 mm to about 26 mm.
45 . A system comprising the device of claim 1 , wherein the device is connected to a connector or pre-loaded in a cylinder.
46 . A kit comprising the device of claim 1 .
47 . A method of bone repair comprising inserting the device of claim 1 into a bone and, optionally, introducing a biomaterial to the internal channel of the device, whereby hardening of the biomaterial secures the device in the bone.