US-12616510-B2 - Devices, systems, and methods for bone repair or implant fixation

Abstract

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.

Inventors

• Thomas A Russell
• Gerard Insley
• Daniel BICHARD
• Ivana IVANKOVIC
• Christophe Geisert
• Tanja LIMBERGER

Assignees

• BIOMIMETIC INNOVATIONS LIMITED

Dates

Publication Date

20260505

Application Date

20220928

Claims (20)

1. 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. 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. 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. 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. 5 . The device of claim 1 , wherein the internal or external thread of the central region is broken by a slit.
6. 6 . The device of claim 5 , wherein the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit.
7. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

Description

BACKGROUND OF THE INVENTION Fixation and repair of damaged bone is frequently compromised due to bone fractures that result in bone loss, compaction, or fragility from injury or disease. Metal, ceramics, and other biostable materials have been used for over a century to treat bone injuries and diseases. Although new biomaterials, with bone substituting and regeneration capabilities, have been developed for use in combination with biostable implants to expedite bone fracture repair, the interface between injectable fluidic biomaterials and the biostable implants cannot be adequately controlled with most devices on the market. Oftentimes implant failure results along with fracture collapse and nonunion with prolonged and disruptive disability for the patient. Thus, there exists a need for devices and methods for effective biomaterial injection, placement, and fixation with robust adherence to surgical implants and bone. SUMMARY OF THE DISCLOSURE The devices, systems, and methods of the disclosure provide implants and uses thereof for repairing bone defects (e.g., bone fractures), stabilizing bone, or providing or improving implant fixation. The implants disclosed herein can be used to achieve uniform distribution and delivery of a biomaterial to the bone to be repaired or to a site of implant fixation. In a first aspect, the disclosure features a device including a unitary body having from a proximal end to a distal end: a proximal region, a central region, and a distal region, in which the central region joins the proximal region to the distal region, and in which: a) the device includes an internal channel extending longitudinally through the proximal, central, and distal regions; b) the proximal region includes an opening to the internal channel and a plurality of circumferentially disposed and compressible wings; c) the central region includes an expandable body configured to radially expand; and d) the distal region includes an opening to the internal channel and internal threads. In some embodiments, the proximal region of the device has an inner diameter of from about 3 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; the central region has 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; or c) the distal region has an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm. In some embodiments, a) the proximal region of the device has an inner diameter of from about 3 mm to about 20 mm (e.g., about 4 mm to about 10 mm, about 5 mm to about 15 mm, or about 10 mm to about 20 mm) and an outer diameter of from about 4 mm to about 25 mm (e.g., about 4 mm to about 10 mm, about 5 mm to about 15 mm, or about 10 mm to about 25 mm); b) the central region has 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 (e.g., about 2 mm to about 5 mm, about 5 mm to about 15 mm, or about 10 mm to about 25 mm); c) the distal region has an inner diameter of from 1 mm to about 20 mm (e.g., about 1 mm to about 5 mm, about 5 mm to about 15 mm, or about 10 mm to about 20 mm) and an outer diameter of from about 4 mm to about 25 mm (e.g., about 4 mm to about 10 mm, about 5 mm to about 15 mm, or about 10 mm to about 25 mm); or d) in which the proximal region, the central region, and the distal region include an inner diameter of from 1 mm to about 20 mm (e.g., about 1 mm to about 5 mm, about 5 mm to about 15 mm, or about 10 mm to about 20 mm) and an outer diameter of from about 1.25 mm to about 25 mm (e.g., about 2 mm to about 5 mm, about 5 mm to about 15 mm, or about 10 mm to about 25 mm). In some embodiments, the outer diameter of the proximal and distal regions is larger than the outer diameter of the central region. In some embodiments, the outer diameter of the proximal and/or distal regions is smaller than the outer diameter of the central region. In some embodiments, the outer diameter of the proximal and/or distal regions is equal to the outer diameter of the central region. In some embodiments, the inner diameter of the proximal and distal regions is larger than the inner diameter of the central region. In some embodiments, the inner diameter of the proximal and/or distal regions is smaller than the inner diameter of the central region. In some embodiments, the inner diameter of the proximal and/or distal regions is equal to the outer diameter of the central region. In some embodiments, the outer diameter from the proximal end to the distal end of the device is the same. In some embodiments, the inner diameter from the proximal end to the distal end of the device is the same. In some embodiments, the device has a length of from about 9 mm to about 110 mm, such as about 9 mm, 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, or 110 mm. In some embodiments, proximal region has a length of from about 2 mm to about 30 mm. In some