Devices, systems and methods for bone repair or implant fixation
Patent Information
- Application Number
- JP2024518797
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-09-28
- Filing Date
- 2022-09-28
- Publication Date
- 2025-10-06
AI Technical Summary
Existing bone repair and implant fixation technologies face challenges in achieving uniform distribution and effective adhesion of biomaterials, leading to implant failure and bone fracture complications.
A device with a proximal, central, and distal region, featuring an internal channel and expandable wings, allows for controlled delivery and fixation of biomaterials by expanding radially within the bone, enhancing adhesion and stability.
The device ensures uniform distribution and fixation of biomaterials, reducing implant failure and promoting bone repair by improving adhesion to surgical implants and bone.
Smart Images

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Abstract
Description
[Technical field]
[0001] background Fixation and repair of damaged bones are frequently compromised by fractures resulting in bone loss, compression, or fragility due to injury or disease. Metals, ceramics, and other biostable materials have been used for over a century to treat bone injuries and diseases. New biomaterials with bone replacement and regeneration capabilities have been developed for use in combination with biostable implants to promote fracture repair, but the interface between the injectable fluid biomaterial and the biostable implant cannot be adequately controlled with most commercially available devices. In many cases, implant failure leads to fracture collapse and nonunion, as well as long-term devastating disability for the patient.
[0002] Thus, a need exists for devices and methods for effective biomaterial injection, placement, and fixation with robust adhesion to surgical implants and bone. Summary of the Invention
[0003] The presently disclosed devices, systems, and methods provide implants and methods of use for repairing bone defects (e.g., fractures), stabilizing bone, or providing or improving implant fixation. The implants disclosed herein can be used to achieve uniform distribution and delivery of biomaterials to the bone being repaired or to the implant fixation site.
[0004] In a first aspect, the present disclosure discloses 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, the central region joining the proximal region to the distal region, where 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 arranged, compressible wings, c) the central region includes an expandable body configured to expand radially, and d) the distal region includes an opening to the internal channel and an internal thread.
[0005] In some embodiments, the proximal region of the device has an inner diameter of about 3 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm, the central region has an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm, or c) the distal region has an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm.
[0006] In some embodiments, a) the proximal region of the device has an inner diameter of 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 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 1 mm to about 20 mm and an outer diameter of 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), and c) the distal region has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 20 mm), and an outer diameter of 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). or d) the proximal region, central region, and distal region have an inner diameter of 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 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) the proximal region, central region, and distal region have an inner diameter of 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 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).
[0007] In some embodiments, the outer diameter of the proximal and distal regions is greater than the outer diameter of the central region. In some embodiments, the outer diameter of the proximal and / or distal regions is less 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.
[0008] 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 of the device from the proximal end to the distal end is the same. In some embodiments, the inner diameter of the device from the proximal end to the distal end is the same.
[0009] In some embodiments, the device has a length of about 9 mm to about 110 mm, e.g., 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, the proximal region has a length of about 2 mm to about 30 mm. In some embodiments, the central region has a length of about 5 mm to about 50 mm. In some embodiments, the distal region has a length of about 2 mm to about 30 mm.
[0010] In some embodiments, the proximal region has a wall thickness of about 0.6 mm to about 2.5 mm (e.g., about 0.6 mm to about 1 mm, about 1 mm to about 2 mm, about 1.25 mm to about 1.75 mm, or about 1.5 mm to about 2.5 mm), optionally with a wall thickness of about 1.5 mm. In some embodiments, the central region has a wall thickness of about 0.15 mm to about 2 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 1 mm to about 2 mm, or about 1.5 mm to about 2 mm), optionally with a wall thickness of about 0.25 mm. In some embodiments, the proximal region has a wall thickness of about 0.6 mm to about 2.5 mm, and optionally, the wall thickness of the proximal region is about 1.5 mm (e.g., about 0.6 mm to about 1 mm, about 1 mm to about 2 mm, about 1.25 mm to about 1.75 mm, or about 1.5 mm to about 2.5 mm).
[0011] In some embodiments, each of the wings of the device includes: a) a rectangular shape having a length and a width; b) a proximal end separate 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.
[0012] In some embodiments, the proximal end of each of the wings of the device is configured to a) protrude outwardly from the proximal region at an angle of about 2° to 10°, and b) reversibly flex toward the proximal region upon compression to substantially eliminate outward protrusion of the proximal end.
[0013] In some embodiments, the wings of the device have a length of about 5 mm to about 20 mm (e.g., about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, such as about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, and 20 mm) and / or a width of 1 mm to 15 mm (e.g., about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, and 15 mm).
[0014] In some embodiments, the device comprises between 3 and 20 wings, for example between 4 and 8 wings, for example 6 wings.
[0015] In some embodiments, the expandable body of the device includes a plurality of openings (e.g., about 2-20 openings), optionally the plurality of openings includes spiral slits, segmented slits, longitudinal slits, or perforations. In some embodiments, the expandable body of the device includes a plurality of openings (e.g., about 2-5000 openings), optionally the plurality of openings includes slits or perforations, optionally the plurality of openings includes spiral slits, segmented slits, longitudinal slits, circumferential slits, circular perforations, elliptical perforations, triangular perforations, polygonal perforations, or irregular perforations. In some embodiments, the expandable body can have between 2 and about 5000 (e.g., between about 2 and about 100, between about 2 and about 200, between about 2 and about 300, between about 2 and about 400, between about 2 and about 500, between about 2 and about 750, between about 2 and about 1000, between about 2 and about 1500, between about 2 and about 2000, between about 2 and about 3000, between about 2 and about 4000, between about 10 and about 50, between about 1 0 to about 100, about 50 to about 100, about 50 to about 250, about 50 to about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, or about 2500 to about 5000 openings.
[0016] In some embodiments, the opening extends into the proximal region and / or the distal region.
[0017] In some embodiments, the opening has a width of about 0.1 mm to about 2 mm and a length of about 1 mm to about 20 mm.
[0018] In some embodiments, the perforations of the device have a circular or elliptical shape with a diameter of about 1 mm to about 5 mm. In some embodiments, the openings include perforations having, for example, a circular, elliptical, triangular, polygonal, or irregular shape, and optionally a diameter of about 0.1 mm to about 5 mm.
[0019] In some embodiments, the opening comprises a perforation, and the plurality of perforations are connected by at least one slit, optionally the slit is a spiral slit, a segmented slit, a longitudinal slit, or a circumferential slit. In some embodiments, the slit connects 2-100 (e.g., 2-10, 2-20, 10-20, 10-30, 10-50, 20-40, 20-60, 40-80, 50-100, 60-80, or 80-100) perforations.
[0020] In some embodiments, the openings include perforations, and the perforations form a mesh or mesh-life structure. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure includes a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure comprises a wire gauge of 5 to 50 (eg, 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0021] In some embodiments, the expandable body includes 1-70 (e.g., 1-2, 1-3, 1-4, 2-4, 2-5, 2-6, 4-8, 5-10, 6-12, 5-15, 10-20, 20-40, 30-60, or 50-70) longitudinal grooves. In some embodiments, the expandable body of the device includes 1-70 (e.g., 1-2, 1-3, 1-4, 2-4, 2-5, 2-6, 4-8, 5-10, 6-12, 5-15, 10-20, 20-40, 30-60, or 50-70) longitudinal grooves. In some embodiments, the longitudinal grooves are about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about In some embodiments, the longitudinal groove extends from a proximal end of the central region to a distal end of the central region.
[0022] In some embodiments, the female threads in the distal region of the device have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm).
[0023] In some embodiments, the distal end of the distal region of the device comprises a blunt edge. In some embodiments, the distal end of the distal region has a tapered edge. In some embodiments, the distal end of the distal region comprises 2-5 milling flutes, optionally the distal region comprises 3 milling flutes. In some embodiments, the distal region comprises 2-4 notches and / or elongated slits, optionally the slits comprise spiral slits, segmented slits, longitudinal slits, or circumferential slits. In some embodiments, the distal region comprises 1-6 openings, optionally each opening has a diameter of about 2 mm to about 5 mm. In some embodiments, the distal region comprises 1-5000 openings, optionally each opening has a diameter of about 0.01 mm to about 5 mm.
[0024] In some embodiments, the distal region includes an external thread. In some embodiments, the external thread has a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the internal or external thread includes a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the external thread is formed of protrusions, grooves, corrugations, or meshes. In some embodiments, the protrusions, grooves, or corrugations are about 1 to about 365 points per 360°. In some embodiments, the male thread comprises a continuous thread or a discontinuous thread. In some embodiments, the male thread is broken by a slit, optionally the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit. In some embodiments, the discontinuous thread comprises a gap, and the gap has a length of about 0.5 mm to about 30 mm.
[0025] In some embodiments, the distal region includes a plurality of bendable tips disposed at the proximal and / or distal end. In some embodiments, the distal region of the device includes a plurality of bendable tips disposed at the distal end. In some embodiments, the proximal region of the device includes an internal thread. In some embodiments, the internal thread of the proximal region has a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm).
[0026] In some embodiments, the proximal region includes an internal or external protrusion. In some embodiments, the internal or external protrusion of the proximal region includes a bump, spike, tab, fin, ridge, or raised surface. In some embodiments, the internal or external protrusion extends from the proximal end to the distal end of the proximal region. In some embodiments, a plurality of internal or external protrusions extend from the proximal end to the distal end of the proximal region. In some embodiments, the device includes 1 to 5000 internal or external protrusions. In some embodiments, the proximal region includes an internal or external thread. In some embodiments, the internal or external thread of the proximal region includes a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the female or male thread is formed from protrusions, grooves, corrugations, or meshes. In some embodiments, the protrusions, grooves, or corrugations are about 1 to about 365 points per 360°. In some embodiments, the female or male thread comprises a continuous thread or a discontinuous thread. In some embodiments, the discontinuous thread comprises a gap, the gap having a length of about 0.5 mm to about 30 mm. In some embodiments, the female or male thread is interrupted by a slit, optionally the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit.
[0027] In some embodiments, the central region includes an internal or external protrusion. In some embodiments, the internal or external protrusion of the central region includes a bump, spike, tab, fin, ridge, or raised surface. In some embodiments, the internal or external protrusion extends from the proximal end to the distal end of the central region. In some embodiments, a plurality of internal or external protrusions extend from the proximal end to the distal end of the central region. In some embodiments, the device includes 1 to 5000 internal or external protrusions. In some embodiments, the central region includes an internal or external thread. In some embodiments, the internal or external thread of the central region includes a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the female or male thread is formed from protrusions, grooves, corrugations, or meshes. In some embodiments, the protrusions, grooves, or corrugations are about 1 to about 365 points per 360°. In some embodiments, the female or male thread comprises a continuous thread or a discontinuous thread. In some embodiments, the discontinuous thread comprises a gap, the gap having a length of about 0.5 mm to about 30 mm. In some embodiments, the female or male thread is interrupted by a slit, optionally the slit is a helical slit, a segmented slit, a longitudinal slit, or a circumferential slit.
[0028] In some embodiments, the one-piece body includes a plurality of longitudinal segments connected by a plurality of expandable arms. In some embodiments, the proximal region, the central region, and / or the distal region include a plurality of segments. In some embodiments, the segments include longitudinal segments. In some embodiments, the plurality of segments extend from the proximal end through the central region to the distal end. In some embodiments, the plurality of segments include a polygonal, circular, triangular, elliptical, cylindrical, or irregular shape, and optionally, the plurality of segments include a rectangular shape. In some embodiments, the one-piece body includes 2-10 segments and the expandable body includes 1-100 expandable arms. In some embodiments, the one-piece body includes 1-50 expandable arms per segment. In some embodiments, each of the segments is the same size. In some embodiments, each of the segments is separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 50 mm. In some embodiments, each of the segments includes a length of about 9 mm to about 110 mm. In some embodiments, each of the segments comprises a width of about 0.1 mm to about 50 mm. In some embodiments, the expandable arms are separated by at least one opening, the opening comprises a maximum width of about 1 mm to about 50 mm. In some embodiments, the unitary body comprises about 1 to 50 pairs of expandable arms. In some embodiments, the pairs of expandable arms are separated by at least one opening, the opening comprises a maximum width of about 0.1 mm to about 50 mm. In some embodiments, the expandable arms are c-shaped, s-shaped, u-shaped, or z-shaped. In some embodiments, the proximal region, the central region, and / or the distal region comprise at least one expandable arm.
[0029] In some embodiments, the central region includes (i) a first section including an expandable body, and (ii) a second section including a plurality of openings. In some embodiments, the central region includes, from the proximal end to the distal end, i) the first section, and ii) the second section. In some embodiments, the first section includes a length of about 5 mm to about 100 mm. In some embodiments, the second section includes a length of about 5 mm to about 100 mm.
[0030] In some embodiments, the device is made of or comprises a material selected from the group consisting of stainless steel or its alloys, titanium or its alloys, magnesium or its alloys, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, xenograft biomaterials, and combinations thereof.
[0031] In some embodiments, the proximal, central, and distal regions of the device are optionally fabricated separately and combined to form a unitary body.
[0032] In a second aspect, the present disclosure features a system including a device as described in the first aspect of the present disclosure, where the device is connected to a connector, a pusher, and / or an insertion tool.
[0033] In some embodiments, the system includes an insertion tool including, from a proximal end to a distal end, a proximal region, a central region, and a distal region, the central region connecting the proximal region to the distal region, a) the proximal region including a handle, b) the central region including a non-threaded shaft having a diameter that terminates in a lip, c) the distal region including a shaft having a reduced diameter relative to the diameter of the shaft in the central region, the distal region further including at least a first set of threads along the shaft and a non-threaded region. In some embodiments, the first set of threads on the distal region of the insertion tool engage the female threads on the proximal and distal regions of the device.
[0034] In some embodiments, the first set of threads on the distal region of the insertion tool have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the distal region of the insertion tool further comprises a second set of threads disposed proximal to the first set of threads. In some embodiments, the second set of threads on the distal region have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the first set of threads and the second set of threads on the distal region of the tool insert are separated by a non-threaded region. In some embodiments, the non-threaded region has a length of about 10 mm to about 100 mm. In some embodiments, the tool insert includes an internal channel extending longitudinally through the proximal region, the central region, and the distal region. In some embodiments, the internal channel of the tool insert is sized to allow a guidewire to pass through the proximal region, the central region, and the distal region of the tool insert.
[0035] In some embodiments, the system includes, or further includes, a connector having a frusto-conical shape having a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region, where a) the proximal region includes a Luer lock thread, b) the distal region of the connector includes a plurality of circumferentially arranged, radially extending wedges, and c) the internal channel of the connector is sized to fit over a non-threaded region of the distal region of an insertion tool.
[0036] In some embodiments, the proximal region of the connector comprises an outer diameter of about 7 mm to about 12 mm and an inner diameter of about 4 mm to about 5 mm.
[0037] In some embodiments, the Luer-lock thread comprises a thread pitch of about 1 mm to about 3 mm (e.g., 2.5 mm). For example, the Luer-lack fitting can comply with an ISO standard (e.g., 80369-7, such as 80369-7-20219).
[0038] In some embodiments, the distal region of the connector comprises a proximal end and a distal end. In some embodiments, the proximal end of the distal region of the connector comprises an outer diameter of about 7 mm to about 26 mm and an inner diameter of about 4 mm to about 24.8 mm. In some embodiments, the distal end of the distal region of the connector comprises an outer diameter of about 1.8 mm to about 18.8 mm and an inner diameter of about 0.6 mm to about 17.6 mm. In some embodiments, the connector comprises a length from proximal region to distal region of about 38 mm to about 120 mm.
[0039] In some embodiments, the connector includes a plurality of wedges, the number of wedges being equal to the number of wings at the proximal region of the device. In some embodiments, the wedges extend from a proximal end to a distal end of the distal region of the connector. In some embodiments, the proximal region of the connector further includes an alignment marker. In some embodiments, the alignment marker includes a colored, textured, or patterned marker. In some embodiments, the connector includes a circumferential groove centrally located in the distal region of the connector. In some embodiments, the circumferential groove is configured to secure the connector to the bone plate. In some embodiments, the wedges of the connector are configured to fasten the distal region of the connector to an internal channel at the proximal region of the device. In some embodiments, the proximal region of the device includes an alignment marker. In some embodiments, the distal region of the connector is configured to be inserted into the internal channel of the device at its proximal region by aligning the alignment marker of the connector with the alignment marker of the device.
[0040] In some embodiments, the system includes, or further includes, a pusher having a proximal region and a distal region, a) the proximal region of the pusher includes a handle, b) the distal region of the pusher includes a cylindrical shape, and c) the pusher further includes an internal channel extending longitudinally through the proximal and distal regions, and the insertion tool includes, in its distal region, a shaft extending through the internal channel of the pusher.
[0041] In some embodiments, the internal channel of the pusher includes an internal thread, and the pusher is rotatable relative to the insertion tool. In some embodiments, the internal thread of the pusher includes a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm).
[0042] In some embodiments, the system includes: a) the insertion tool includes, from a proximal end to a distal end, a proximal region, a central region, and a distal region, the central region connecting the proximal region to the distal region, the proximal region including a handle, the central region including a non-threaded shaft having a diameter terminating in a lip, the distal region including a shaft having a reduced diameter relative to the diameter of the shaft in the central region, the distal region further including a first set of threads disposed distally from a second set of threads and an non-threaded region separating the first and second sets of threads; b) the pusher includes a proximal region and a distal region, the proximal region including a handle, the distal region including a cylindrical shape, the pusher further including an internal channel extending longitudinally through the proximal and distal regions, the internal channel including a set of threads, the pusher being rotatable relative to the insertion tool; and c) the connector includes a proximal region and a distal region. and an internal channel extending from a proximal region to a distal region, the proximal region including luer lock threads and the distal region including a plurality of circumferentially arranged, radially extending wedges, where a) the wedges of the connector secure the distal region of the connector to the internal channel at the proximal region of the device, b) a shaft of the distal region of the insertion tool traverses the internal channel of the pusher from its proximal region to its distal region, a second set of threads of the distal region of the insertion tool engage with a set of threads of the internal channel of the pusher, c) a first set of threads of the distal region of the insertion tool traverse longitudinally the internal channel of the connector and engage with female threads of the distal region of the device, d) the internal channel of the connector fits over the unthreaded region of the distal region of the insertion tool, and e) the proximal region of the connector contacts the distal region of the pusher.
[0043] In a third aspect, the disclosure features a method of bone repair or implant fixation, the method including inserting into bone a device of the first aspect of the disclosure.
[0044] In some embodiments, prior to inserting the device into the bone, the method includes drilling a hole in the bone, and the inserting includes depositing the device in the hole (e.g., screwing the device into the bone at the site of the hole).
[0045] In some embodiments, the method further comprises compressing the device prior to inserting the device into the bone.
[0046] In some embodiments, compression of the device is maintained by a deployment device.
[0047] In some embodiments, the method includes inserting the device into the bone until the proximal end contacts the bone. The method further includes anchoring the proximal region of the device in the bone, such as by friction-fitting wings of the proximal region of the device against the bone. In some embodiments, the method further includes expanding the expandable body. In some embodiments, the method further includes expanding the expandable body by releasing the device from a compressed state. In some embodiments, the method includes expanding the expandable body by rotating the distal region of the device relative to the proximal region (e.g., the distal region rotates while the proximal region remains fixed). In other embodiments, the method includes expanding the expandable body using a balloon. The balloon (e.g., in a deflated or partially expanded state) may be inserted into the internal channel of the device after insertion into the hole in the bone. After insertion, the balloon may be inflated to expand the expandable body of the device.
[0048] In some embodiments, the method further includes introducing a biomaterial into an interior channel of the device after expansion of the expandable body.
[0049] In some embodiments, the method includes distributing the biomaterial evenly throughout the device and into the bone surrounding the device (e.g., by inserting screws or other hardware into internal channels of the device and displacing the biomaterial from the internal channels, e.g., through slits in the helix or other holes, perforations, or slots in the device, and into the bone).
[0050] In some embodiments, upon expansion of the expandable body, the opening in the expandable body expands, hi some embodiments, the delivery of a volume of biomaterial is proportional to the expansion of the opening in the expandable body.
[0051] In some embodiments, the biomaterial hardens, thereby anchoring the device to the bone.
[0052] In some embodiments, the method includes inserting a screw having a length through an internal channel of the device, thereby promoting an even distribution of the biomaterial throughout the device and into the bone surrounding the device. The screw can remain within the device to provide additional stability and fixation support. Alternatively, the screw can be inserted into the internal channel of the device after the biomaterial has hardened.
[0053] In some embodiments, the method further includes aligning the screw with internal protrusions or threads in the proximal region, the central region, and / or the distal region.
[0054] In some embodiments, the length of the screw traverses the length of the internal channel of the device, and the method further includes fastening a distal end of the screw to the distal cortex of the bone, and optionally, fastening the screw within the distal cortex creates bone compression (e.g., when used in combination with a bone plate or washer to apply pressure to the bone cortex opposite the tip of the screw).
[0055] In some embodiments, the screw comprises a thread having a diameter of about 1 mm to about 20 mm, a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm), a non-threaded body, or a material selected from the group consisting of stainless steel or alloys thereof, titanium or alloys thereof, magnesium or alloys thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, and combinations thereof. In some embodiments, the screw comprises a length of about 5 mm to about 300 mm (e.g., about 5 mm to about 125 mm), including any length within this range.
[0056] In some embodiments, the method further includes securing a bone plate to the bone using the device, optionally the bone plate including at least one hole providing access to an interior channel of the device.
[0057] In some embodiments, the method further comprises securing the bone plate to the bone by inserting screws through the bone plate holes and the internal channels of the device and fastening distal ends of the screws to the distal cortex of the bone.
[0058] In some embodiments, the bone plate includes two or more bone plate holes (e.g., three, four, five, six or more holes) and the method can include securing the bone plate to the bone using two or more devices of the first aspect of the disclosure that are placed into the bone through the bone plate holes.
[0059] In some embodiments, the method further includes placing a washer in the internal channel at the proximal region of the device, optionally wherein the washer includes a proximal region, a distal region, and an internal channel extending longitudinally through the proximal and distal regions of the washer.
[0060] In some embodiments, prior to inserting the screw through the internal channel of the device, the method further includes placing a washer within the internal channel at a proximal region of the device, the washer including a proximal region, a distal region, and an internal channel extending longitudinally through the proximal and distal regions of the washer, and inserting the screw through the internal channel of the washer and through the internal channel of the device. The washer can be used to narrow the channel at the proximal region of the device to promote compression and minimize the risk of unintentional penetration of the screw head through the cortical bone during screw insertion.
[0061] In some embodiments, the proximal region of the washer has an outer diameter of about 5 mm to about 30 mm and / or an inner diameter of about 2 mm to about 20 mm, and / or the distal region of the washer has an outer diameter of about 2.8 mm to about 19.8 mm and / or an inner diameter of about 2 mm to about 18 mm, and / or the outer diameter of the proximal region of the washer is greater than the outer diameter of the distal region of the washer.
[0062] In some embodiments, prior to or after insertion of the device into the bone, the method further includes inserting a connector into an internal channel in a proximal region of the device, the connector having a frusto-conical shape having a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region, wherein a) the proximal region includes a Luer lock thread, and b) the distal region of the connector includes a plurality of circumferentially arranged, radially extending wedges.
[0063] In some embodiments, the method includes fastening a connector to an internal channel at a proximal region of the device after the device is inserted into the bone and after the proximal region of the device is anchored in the bone.
[0064] In some embodiments, the connector further comprises an alignment marker.
[0065] In some embodiments, the method includes coupling a biomaterial dispenser having a biomaterial to the connector using a luer lock thread. In some embodiments, the biomaterial dispenser includes a syringe, vial, or reservoir sized to hold a suitable volume of biomaterial (e.g., a volume of about 1 ml to about 20 ml). The syringe, vial, or reservoir may include a tube. In some embodiments, the method includes introducing a volume of biomaterial of about 1 ml to about 20 ml into an interior channel of the device (e.g., from the biomaterial dispenser). In some embodiments, the volume of biomaterial introduced into the device is about 2.5 ml, about 5 ml, or about 10 ml.
[0066] In some embodiments, the biomaterial comprises a polymer adhesive, a bone void filling material, a cement, a phosphoserine-based bioadhesive, a cohesive agent, a bone forming agent, a drug, or a pharmaceutical agent.
[0067] In some embodiments, the biomaterial is a calcium phosphate based bone cement, a non-self-setting calcium phosphate based bone void filler, a flowable xenograft bone void filler, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(alpha-hydroxy acid), a poly(lactone), a poly(amino acid), a poly(anhydride), a poly(orthoester), a poly(anhydride-co-imide), a poly(orthocarbonate), a poly(alpha-hydroxyalkanoate), a poly(dioxanone), a poly(phosphoester), a poly(L-lactide) (PLLA), a poly(D,L-lactide) (PDLLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a poly(L-lactide-co-D,L-lactide), a poly(D,L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(ε-caprolactone), poly(δ-valerolactone), poly(γ-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fiber, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide), block copolymer, poly(ethylene terephthalate) polyamide, potassium acrolein, (meth)acrylamide, homopolymer or copolymer containing one or more monomers selected from the group consisting of (meth)acrylic acid and salts thereof, (meth)acrylate, acrylonitrile, ethylene, ethylene glycol, ethyleneimine, ethylene oxide oxide, styrene sulfonate, vinyl acetate, vinyl alcohol, vinyl chloride, vinyl pyrrolidone, gallotannins, ellagitannins, taragallotannins, caffetannins, proanthocyanidins, catechin, epicatechin, chlorogenic acid, and arbutin, polyphenol complexing agents selected from alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethyl chitosan, de xtran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, cellulose, glucosamine, proteoglycan, starch, lactic acid, pluronic, sodium glycerophosphate, collagen, glycogen, keratin, silk, transforming growth factor-beta (TGF-β), activin, inhibin, bone morphogenetic protein (BMP), antibiotics, enzyme inhibitors, antihistamines, anti-inflammatory agents, muscle relaxants, antispasmodics, analgesics, prostaglandins, antidepressants, nutritional factors, or hormones.
[0068] In some embodiments, the method includes separating the biomaterial dispenser and / or connector from the proximal region of the device after the biomaterial is introduced into the internal channel of the device.
[0069] In some embodiments, the device is inserted into the bone using an insertion tool. The insertion tool can include, from a proximal end to a distal end, a proximal region, a central region, and a distal region, the central region connecting the proximal region to the distal region, the proximal region including a handle, the central region including a non-threaded shaft having a diameter terminating in a lip, the distal region including a shaft having a reduced diameter relative to the diameter of the shaft in the central region, the distal region further including a first set of threads disposed distally from a second set of threads, and an unthreaded region separating the first and second sets of threads, the distal region threads of the insertion tool configured to engage with the female threads of the distal region of the device. When using the insertion tool to place the device of the first aspect into the bone, the method further includes engaging the device with the insertion tool (at the distal region of the insertion tool) and twisting the insertion tool until the device is placed (e.g., screwed) into the bone.
[0070] In some embodiments, during insertion of the device into the bone, the wings of the proximal region of the device compress, e.g., as they contact the bone (e.g., when the device is fully inserted into the bone, the proximal region contacts the bone, which causes the wings of the device to compress). The method further includes rotating the device until the wings are allowed to expand (fully or partially return to their natural expanded state) once inserted into the bone. The expansion of the wings applies pressure against the bone (e.g., by friction fit), thereby anchoring the proximal region of the device in the bone (e.g., anchoring the device in the bone) so that the proximal region of the device can resist rotation, e.g., so that the distal end can be rotated independently from the proximal end.
[0071] In some embodiments, the method further includes assembling a system including the device, the insertion tool, the pusher, and the connector prior to engaging the insertion tool with the device. The pusher includes a proximal region (e.g., including a handle) and a distal region with a cylindrical shape. The pusher further includes a threaded internal channel extending longitudinally through the proximal and / or distal regions. The system can also include a connector having a frusto-conical shape with a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region. The proximal region of the connector includes Luer lock threads, and the distal region of the connector includes a plurality of circumferentially disposed, radially extending wedges (the wedges are configured to mate with the inside of the wings of the device to lock the connector into the device). Assembling includes: a) threading the threaded inner channel of the pusher along the shaft of the distal region of the insertion tool until the threaded inner channel engages the second set of threads of the distal region of the insertion tool and the proximal region of the pusher is adjacent the central region of the insertion tool; b) sliding the inner channel of the connector along the shaft of the distal region of the insertion tool until the connector overlaps with the non-threaded region of the distal region of the insertion tool, the connector being located distal to the pusher; and c) inserting the shaft of the distal region of the insertion tool through the inner channel of the device until the first set of threads of the insertion tool engage the female threads of the distal region of the device.
[0072] In some embodiments, the method further includes a) inserting the device into the bone by twisting a handle of the insertion device until the device is fully inserted into the bone, and b) inserting the connector into an internal channel of the proximal region of the device by twisting a handle of the pusher until a distal region of the pusher engages a proximal region of the connector, whereby twisting translates the connector along the shaft of the insertion tool until the distal region of the connector engages the internal channel of the proximal region of the device. Insertion of the connector into the proximal region of the device causes expansion of the wings of the device (e.g., from a compressed state resulting from insertion of the device into the bone) as wedges of the connector mate with the inside of the proximal region of the device corresponding to the wings. Expansion of the wings of the device upon insertion of the connector secures (e.g., fixes or immobilizes) the proximal region of the device into the bone.
[0073] In some embodiments, the method further includes radially expanding the expandable body of the device by a) immobilizing a proximal region of the device using the pusher and connector; and b) twisting the handle of the insertion tool in a first direction, whereby the distal region of the device twists independently from the fixed proximal region of the device, thereby compressing the device and radially expanding the expandable body.
[0074] In some embodiments, the method further includes, after expanding the expandable body of the device, decoupling the pusher from the connector and removing the insertion tool from the device by twisting the handle of the insertion tool in a second direction opposite the first direction. In some embodiments, the expandable body maintains the expanded configuration after removing the pusher and insertion tool from the device. In some embodiments, the first direction is clockwise and the second direction is counterclockwise. In some embodiments, the first direction is counterclockwise and the second direction is clockwise.
[0075] In some embodiments, the method comprises inserting a device into the bone using the system of the second aspect of the present disclosure.
[0076] In some embodiments, the method includes coupling the connector to the biomaterial dispenser after decoupling the pusher and insertion tool from the device.
[0077] In a fourth aspect, the present disclosure features an extraction tool that can be used to remove a device from a bone after insertion of the device into the bone. The extraction tool includes a proximal region, a central region, and a distal region from a proximal end to a distal end, the proximal region includes a grip handle, the central region includes a pivot joint, and the distal region includes a pair of nubs and two members pivotally coupled by the pivot joint. In some embodiments, the two members each include a nub that forms a pair of nubs. In some embodiments, the pair of nubs are sized to fit into a notch, elongated slit, or opening present in a distal region of a device of the present disclosure (e.g., a device of the first aspect of the present disclosure). In some embodiments, the distal region of the extraction tool is sized to traverse an internal channel of the device from the proximal end to the distal end.
[0078] In a fifth aspect, the disclosure features a method of extracting a device from a bone. The method includes inserting a distal region of an extraction tool into an internal channel of the device, engaging (e.g., fixedly engaging) a pair of nubs of the extraction tool with notches, elongated slits, or openings present in the distal region of the device, and once engaged with the device, twisting the extraction tool to remove the device from the bone. In some embodiments, the method includes twisting the extraction tool clockwise to remove the device from the bone or twisting the extraction tool counterclockwise to remove the device from the bone. In some embodiments, prior to extracting the device, the method includes removing a screw (e.g., a bone screw) from the device.
[0079] In a sixth aspect, the present disclosure features a kit including a device described herein (e.g., the device of the first aspect). The kit can be used for treating bone defects, repairing or stabilizing bone, or attaching an implant to bone. The kit can include instructions for using the kit to treat bone defects, repair or stabilizing bone, or attach an implant to bone. In some embodiments, the kit further includes one or more of an insertion tool, an extraction tool, a pusher, a connector, a screw, a washer, a container containing biomaterial, a biomaterial dispenser, and a bone plate.
[0080] The insertion tool of the kit includes, from a proximal end to a distal end, a proximal region, a central region, and a distal region, the central region connecting the proximal region to the distal region, the proximal region including a handle, the central region including a non-threaded shaft having a diameter that terminates in a lip, the distal region including a shaft having a reduced diameter relative to the diameter of the shaft in the central region, the distal region further including a first set of threads disposed distally from the second set of threads and a non-threaded region separating the first set of threads and the second set of threads.
[0081] The extraction tool of the kit includes, from the proximal end to the distal end, a proximal region, a central region, and a distal region, the proximal region including a grip handle, the central region including a pivot joint, and the distal region including a pair of nubs and two members pivotally connected by the pivot joint.
[0082] The pusher of the kit includes a proximal region and a distal region, the proximal region of the pusher includes a handle and the distal region of the pusher includes a cylindrical shape, the pusher further includes a threaded internal channel extending longitudinally through the proximal and distal regions, The pusher is configured for engagement with an insertion tool such that a second set of threads of the distal region of the insertion tool is configured to engage the threaded internal channel of the pusher.
[0083] The connector of the kit includes a frusto-conical shape having a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region, the proximal region including a Luer lock thread, the distal region of the connector including a plurality of circumferentially disposed, radially extending wedges, and the internal channel of the connector sized to fit over the non-threaded region of the distal region of the insertion tool.
[0084] In some embodiments, the kit further comprises a screw (eg, a bone screw), the screw comprising a sufficient length to traverse the length of the device. The screw may, for example, comprise a screw head, a thread having a diameter of about 1 mm to about 20 mm, a length of about 5 mm to about 300 mm (e.g., about 5 mm to about 50 mm), a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm), a non-threaded body, and / or 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 (registered trademark) 45S5, a ceramic composite, a copper-based material or composite, cobalt chromium, and combinations thereof.
[0085] The washer of the kit includes a proximal region, a distal region, and an internal channel extending longitudinally through the proximal and distal regions of the washer, the washer being sized to fit within the internal channel of the proximal region of the device. The proximal region of the washer may have an outer diameter of about 5 mm to about 30 mm and an inner diameter of about 1 mm to about 20 mm. The distal region of the washer may have an outer diameter of about 2.8 mm to about 19.8 mm and an inner diameter of about 1 mm to about 20 mm. The outer diameter of the proximal region of the washer is preferably greater than the outer diameter of the distal region of the washer.
[0086] In some embodiments, the kit further comprises a biomaterial, which may include a polymer adhesive, a bone void filling material, a cement, a phosphoserine-based bioadhesive, a cohesive agent, a bone forming agent, a drug, or a pharmaceutical agent. In other embodiments, the biomaterial is a calcium phosphate based bone cement, a non-self-setting calcium phosphate based bone void filler, a flowable xenograft bone void filler, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(alpha-hydroxy acid), a poly(lactone), a poly(amino acid), a poly(anhydride), a poly(orthoester), a poly(anhydride-co-imide), a poly(orthocarbonate), a poly(alpha-hydroxyalkanoate), a poly(dioxanone), a poly(phosphoester), a poly(L-lactide) (PLLA), a poly(D,L-lactide) (PDLLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a poly(L-lactide-co-D,L-lactide), a poly(D,L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(ε-caprolactone), poly(δ-valerolactone), poly(γ-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fiber, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide), block copolymer, poly(ethylene terephthalate) polyamide, potassium acrolein, (meth)acrylamide, homopolymer or copolymer containing one or more monomers selected from the group consisting of (meth)acrylic acid and salts thereof, (meth)acrylate, acrylonitrile, ethylene, ethylene glycol, ethyleneimine, ethylene oxide oxide, styrene sulfonate, vinyl acetate, vinyl alcohol, vinyl chloride, vinyl pyrrolidone, gallotannins, ellagitannins, taragallotannins, caffetannins, proanthocyanidins, catechin, epicatechin, chlorogenic acid, and arbutin, polyphenol complexing agents selected from alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethyl chitosan, de xtran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, cellulose, glucosamine, proteoglycan, starch, lactic acid, pluronic, sodium glycerophosphate, collagen, glycogen, keratin, silk, transforming growth factor-beta (TGF-β), activin, inhibin, bone morphogenetic protein (BMP), antibiotics, enzyme inhibitors, antihistamines, anti-inflammatory agents, muscle relaxants, antispasmodics, analgesics, prostaglandins, antidepressants, nutritional factors, or hormones.
[0087] In some embodiments, the kit further includes a biomaterial dispenser, which may include, for example, a syringe, vial, or tube connected to a reservoir sized to hold a volume of biomaterial, hi some embodiments, the biomaterial dispenser contains the biomaterial (i.e., the biomaterial is preloaded into the biomaterial dispenser).
[0088] In some embodiments, the kit further includes a bone plate, which can have one hole or multiple holes (eg, two or more bone plate holes).
[0089] In a seventh aspect, the present disclosure features a device including a unitary body including, from a proximal end to a distal end, a proximal region, a central region, and a distal region, the central region joining the proximal region to the distal region, where a) the device includes an internal channel extending longitudinally through the proximal, central, and distal regions, b) the proximal region includes a compressible body and an opening to the internal channel, c) the central region includes i) a plurality of openings, and ii) an expandable and / or compressible body configured to radially expand or compress, the expandable and / or compressible body including a plurality of longitudinal segments, and d) the distal region includes an opening to the internal channel.
[0090] In some embodiments, a) the proximal region comprises an inner diameter of about 3 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm; b) the central region comprises an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm; c) the distal region comprises an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm; or d) the proximal region, central region, and distal region comprise an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm.
[0091] In some embodiments, the outer diameter of the proximal and distal regions is greater than the outer diameter of the central region.
[0092] In some embodiments, the device further comprises a length of about 9 mm to about 110 mm. In some embodiments, the proximal region comprises a length of about 2 mm to about 30 mm (e.g., about 2 mm to about 5 mm, about 2 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, or about 20 mm to about 30 mm). In some embodiments, the central region comprises a length of about 5 mm to about 100 mm. In some embodiments, the distal region comprises a length of about 2 mm to about 30 mm (e.g., about 2 mm to about 5 mm, about 2 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, or about 20 mm to about 30 mm).
[0093] In some embodiments, the proximal region comprises a wall thickness of about 0.6 mm to about 2.5 mm, optionally the wall thickness of the proximal region is about 1.5 mm, in some embodiments, the central region comprises a wall thickness of about 0.15 mm to about 2 mm, optionally the wall thickness of the central region is about 0.25 mm.
[0094] In some embodiments, the distal region comprises a wall thickness of about 0.6 mm to about 2.5 mm, and optionally, the wall thickness of the distal region is about 1.5 mm.
[0095] In some embodiments, the outer diameter from the proximal end to the distal end is the same, hi some embodiments, the proximal, central, and distal regions comprise an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm.
[0096] In some embodiments, the proximal region, or the compressible body of the proximal region, comprises a mesh or mesh-like structure. In some embodiments, the mesh or mesh-like structure comprises a diamond, square, circular, woven, or elliptical opening pattern. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure comprises a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure comprises a wire gauge of 5 to 50 (eg, 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0097] In some embodiments, the compressible body of the proximal region includes a flared shape.
[0098] In some embodiments, the compressible body of the proximal region includes a plurality of circumferentially arranged compressible wings. In some embodiments, each of the wings includes a) a rectangular, circular, elliptical, triangular, sawtooth, or parabolic shape including a length and a width; b) a proximal end separated from the proximal region and configured to project 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. In some embodiments, the proximal end of each of the wings a) projects outwardly from the proximal region at an angle of about 2° to 10°; and b) is configured to reversibly flex toward the proximal region upon compression to substantially eliminate outward projection of the proximal end. In some embodiments, the wings include a length of about 5 mm to about 20 mm and / or a width of 1 mm to 15 mm. In some embodiments, the device includes 3 to 20 wings, preferably the device includes 4 to 8 wings, e.g., 6 wings.
[0099] In some embodiments, the plurality of openings comprises slits or perforations, and optionally the plurality of openings comprises spiral slits, segmented slits, longitudinal slits, circumferential slits, circular perforations, elliptical perforations, triangular perforations, polygonal perforations, or irregular perforations. In some embodiments, the openings extend into the proximal region and / or the distal region.
[0100] In some embodiments, the expandable and / or compressible body of the central region has from 2 to about 5000 openings (e.g., from about 2 to about 100, from about 2 to about 200, from about 2 to about 300, from about 2 to about 400, from about 2 to about 500, from about 2 to about 750, from about 2 to about 1000, from about 2 to about 1500, from about 2 to about 2000, from about 2 to about 3000, from about 2 to about 4000, , about 10 to about 50, about 10 to about 100, about 50 to about 100, about 50 to about 250, about 50 to about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, or about 2500 to about 5000).
[0101] In some embodiments, the opening comprises a width of about 0.01 mm to about 2 mm (e.g., about 0.01 mm to about 0.1 mm, about 0.01 mm to about 0.3 mm, about 0.01 mm to about 0.5 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 1 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1.5 mm, or about 1.5 mm to about 2 mm) and a length of about 0.01 mm to about 20 mm. In some embodiments, the plurality of openings comprises perforations, and the perforations comprise a circular, elliptical, triangular, polygonal, or irregular shape with a diameter of about 0.01 mm to about 5 mm (e.g., about 0.01 mm to about 0.1 mm, about 0.01 mm to about 0.3 mm, about 0.01 mm to about 0.5 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 1 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1.5 mm, about 1 mm to about 5 mm, about 1.5 mm to about 2 mm, about 2 mm to about 5 mm, about 2 mm to about 8 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, or about 10 mm to about 20 mm).
[0102] In some embodiments, the openings include staggered or linear openings.
[0103] In some embodiments, the plurality of openings comprises perforations, the perforations being connected by slits, optionally comprising spiral, segmented, longitudinal, or circumferential slits. In some embodiments, the slits connect 2-100 perforations (e.g., 2-10, 2-20, 10-20, 10-30, 10-50, 20-40, 20-60, 40-80, 50-100, 60-80, or 80-100).
[0104] In some embodiments, the openings include perforations, and the perforations form a mesh or mesh-like structure. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure includes a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure includes a wire gauge of 5 to 50 (e.g., 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0105] In some embodiments, the expandable and / or compressible body of the central region includes 1 to 70 (e.g., 1 to 2, 1 to 3, 1 to 4, 2 to 4, 2 to 5, 2 to 6, 4 to 8, 5 to 10, 6 to 12, 5 to 15, 10 to 20, 20 to 40, 30 to 60, or 50 to 70) longitudinal grooves. In some embodiments, the longitudinal grooves are about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about In some embodiments, the longitudinal groove extends from a proximal end of the central region to a distal end of the central region.
[0106] In some embodiments, the distal end of the distal region comprises a blunt and / or tapered edge. In some embodiments, the distal end of the distal region comprises 2-5 milling flutes, optionally the distal region comprises 3 milling flutes. In some embodiments, the distal region comprises 2-4 notches and / or elongated slits, optionally the slits comprise helical slits, segmented slits, longitudinal slits, or circumferential slits.
[0107] In some embodiments, the distal region comprises between 1 and 5000 openings, optionally with each opening having a diameter between about 0.01 mm and about 5 mm.
[0108] In some embodiments, the proximal region, the central region, and / or the distal region include internal or external protrusions. In some embodiments, the internal or external protrusions include one or more of bumps, spikes, tabs, fins, ridges, or raised surfaces. In some embodiments, the internal or external protrusions extend from the proximal end of the device to the distal end, the proximal region, the central region, or the distal region. In some embodiments, a plurality of internal or external protrusions extend from the proximal end of the device to the distal end, the proximal region, the central region, or the distal region. In some embodiments, the device includes 1-5000 internal or external protrusions. The internal or external protrusions, which can be molded into a thread-like pattern, can be configured to replicate the function of a screw thread.
[0109] In some embodiments, the proximal region, the central region, and / or the distal region include female or male threads. In some embodiments, the female or male threads have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the female or male threads are formed from protrusions, grooves, corrugations, or meshes. In some embodiments, the protrusions, grooves, or corrugations are about 1 to about 365 points per 360° (e.g., 4 to 20 equidistant points along the circumference of the proximal region, the central region, and / or the distal region). In some embodiments, the female or male threads include continuous or discontinuous threads. In some embodiments, the discontinuous threads include gaps, optionally the gaps having a length of about 0.5 mm to about 30 mm. In some embodiments, the female or male threads are interrupted by slits, optionally the slits are helical slits, segmented slits, longitudinal slits, or circumferential slits.
[0110] In some embodiments, the longitudinal segments are connected by the expandable arms. In some embodiments, the proximal and / or distal regions include a plurality of segments. In some embodiments, the segments include longitudinal segments. In some embodiments, the central region's segments extend into the proximal and / or distal regions. In some embodiments, the segments extend from the proximal end through the central region to the distal end. In some embodiments, the segments are polygonal, circular, triangular, elliptical, cylindrical, or irregular, and optionally, the segments are rectangular. In some embodiments, the device includes 2-20 (e.g., 2-4, 2-6, 2-8, 2-10, 4-8, 4-10, 4-12, 10-16, or 10-20) segments, and the expandable body includes 1-100 expandable arms. In some embodiments, the unitary body includes 1-50 expandable arms per segment. In some embodiments, each of the segments is the same size. In some embodiments, each of the segments is separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 50 mm. In some embodiments, each of the segments comprises a length of about 9 mm to about 110 mm. In some embodiments, each of the segments comprises a width of about 0.1 mm to about 50 mm. In some embodiments, the expandable arms are separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 50 mm. In some embodiments, the unitary body comprises 1 to 50 pairs of expandable arms. In some embodiments, the pairs are separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 20 mm. In some embodiments, the expandable arms are c-shaped, s-shaped, u-shaped, or z-shaped. In some embodiments, the proximal region, the central region, and / or the distal region comprises at least one expandable arm.
[0111] In some embodiments, the central region includes (i) a first section including an expandable and / or compressible body, and (ii) a second section including a plurality of openings. In some embodiments, the central region includes, from the proximal end to the distal end, i) the first section, and ii) the second section. In some embodiments, the first section includes a length of about 5 mm to about 100 mm. In some embodiments, the second section includes a length of about 5 mm to about 100 mm.
[0112] In an eighth aspect, the disclosure features a device including a unitary body including a proximal end and a distal end, a) the unitary body includes an expandable and / or compressible body configured to radially expand or compress, the unitary body includes a rolled surface having an internal channel extending longitudinally from the proximal end to the distal end, b) the unitary body includes a plurality of openings, c) the internal channel includes an internal protrusion and / or internal threads, d) the proximal end includes an opening to the internal channel, and e) the distal end includes an opening to the internal channel.
[0113] In some embodiments, the unitary body includes, from the proximal end to the distal end, a proximal region, a central region, and a distal region, with the central region joining the proximal region to the distal region. In some embodiments, the proximal region includes a length of about 0.5 mm to about 30 mm. In some embodiments, the central region includes a length of about 5 mm to about 50 mm. In some embodiments, the distal region includes a length of about 0.5 mm to about 30 mm. In some embodiments, the proximal region and / or the distal region do not include an opening.
[0114] In some embodiments, a) the one-piece body comprises an inner diameter of about 1.25 mm to about 25 mm, b) the proximal region comprises an inner diameter of about 3 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm, c) the central region comprises an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm, d) the distal region comprises an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm, or e) the proximal region, central region, and distal region comprise an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm.
[0115] In some embodiments, the outer diameter is constant from the proximal end to the distal end.
[0116] In some embodiments, the device comprises a length of about 9 mm to about 110 mm.
[0117] In some embodiments, the unitary body comprises a wall thickness of about 0.6 mm to about 2.5 mm. In some embodiments, the proximal region comprises a wall thickness of about 0.6 mm to about 2.5 mm, optionally the wall thickness of the proximal region is about 1.5 mm. In some embodiments, the central region comprises a wall thickness of about 0.15 mm to about 2 mm, optionally the wall thickness of the central region is about 0.25 mm. In some embodiments, the distal region comprises a wall thickness of about 0.6 mm to about 2.5 mm, optionally the wall thickness of the distal region is about 1.5 mm.
[0118] In some embodiments, the plurality of openings comprises slits or perforations, and optionally the openings comprise spiral slits, segmented slits, longitudinal slits, circumferential slits, circular perforations, elliptical perforations, or polygonal perforations, hi some embodiments, the openings comprise staggered openings or linear openings.
[0119] In some embodiments, the plurality of openings comprises perforations, and the perforations are connected by slits. In some embodiments, 2-100, 2-10, 2-20, 10-20, 10-30, 10-50, 20-40, 20-60, 40-80, 50-100, 60-80, or 80-100 perforations are connected by slits, and optionally the slits comprise spiral slits, segmented slits, longitudinal slits, or circumferential slits.
[0120] In some embodiments, the openings in the unitary body form a mesh or mesh-like structure. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure comprises a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure comprises a wire gauge of 5 to 50 (e.g., 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0121] In some embodiments, the one-piece body has from 2 to 5000 openings (e.g., from about 2 to about 100, from about 2 to about 200, from about 2 to about 300, from about 2 to about 400, from about 2 to about 500, from about 2 to about 750, from about 2 to about 1000, from about 2 to about 1500, from about 2 to about 2000, from about 2 to about 3000, from about 2 to about 4000, from about 10 to about 50, about 10 to about 100, about 50 to about 100, about 50 to about 250, about 50 to about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, or about 2500 to about 5000). In some embodiments, the central region has 2 to 5000 openings (e.g., about 2 to about 100, about 2 to about 200, about 2 to about 300, about 2 to about 400, about 2 to about 500, about 2 to about 750, about 2 to about 1000, about 2 to about 1500, about 2 to about 2000, about 2 to about 3000, about 2 to about 4000, about 10 to about 50, about 10 to about 100, about 50 to about 100, about 50 to about 250, about 50 to about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, or about 2500 to about 5000).
[0122] In some embodiments, the opening comprises a width of about 0.1 mm to about 2 mm and a length of about 0.1 mm to about 20 mm. In some embodiments, the plurality of openings comprises perforations, the perforations comprising a circular or elliptical shape with a diameter of about 0.1 mm to about 5 mm.
[0123] In some embodiments, the expandable and / or compressible body includes 2 to 70 (e.g., 1 to 2, 1 to 3, 1 to 4, 2 to 4, 2 to 5, 2 to 6, 4 to 8, 5 to 10, 6 to 12, 5 to 15, 10 to 20, 20 to 40, 30 to 60, 50 to 70) longitudinal grooves. In some embodiments, the longitudinal grooves are about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, In some embodiments, the longitudinal groove extends from a proximal end of the central region to a distal end of the central region.
[0124] In some embodiments, the proximal region, the central region, and / or the distal region include an internal protrusion. In some embodiments, the unitary body includes an external protrusion, and optionally the proximal region, the central region, and / or the distal region include an external protrusion, or optionally the external protrusion is a bump, spike, tab, fin, ridge, or raised surface. In some embodiments, the internal protrusion is a bump, spike, tab, fin, ridge, or raised surface. In some embodiments, the internal or external protrusion extends from the proximal end to the distal end, proximal region, central region, or distal region of the device. In some embodiments, a plurality of internal or external protrusions extend from the proximal end to the distal end, proximal region, central region, or distal region of the device. In some embodiments, the device includes 1 to 5000 internal or external protrusions. The internal or external protrusions, which can be molded into a thread-like pattern, can be configured to replicate the function of a screw thread.
[0125] In some embodiments, the proximal region, the central region, and / or the distal region include an internal thread. In some embodiments, the unitary body includes an external thread, and optionally the proximal region, the central region, and / or the distal region include an external thread. In some embodiments, the internal or external thread has a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm). In some embodiments, the internal or external thread is formed from protrusions, grooves, corrugations, or meshes. In some embodiments, the protrusions, grooves, or corrugations are about 1 to about 365 points per 360° (e.g., 4 to 20 equidistant points along the circumference of the proximal region, the central region, and / or the distal region). In some embodiments, the female or male thread comprises a continuous thread or a discontinuous thread. In some embodiments, the female or male thread is broken by a slit. In some embodiments, the discontinuous thread comprises a gap, and the gap has a length of about 0.5 mm to about 30 mm.
[0126] In some embodiments, the proximal end comprises a blunt and / or tapered edge. In some embodiments, the distal end comprises a blunt and / or tapered edge. In some embodiments, the distal end comprises a milling flute. In some embodiments, the distal end comprises 2-5 milling flutes, and optionally the distal region comprises 3 milling flutes. In some embodiments, the distal region comprises 2-4 notches and / or elongated slits. In some embodiments, the distal region comprises a plurality of bendable tips disposed at the proximal end and / or the distal end.
[0127] In some embodiments, the rolling surface has a left side and a right side, and when radially expanded, the left side and the right side overlap by about 0.1 mm to about 20 mm. In some embodiments, when radially expanded, the rolling surfaces do not overlap. In some embodiments, the right side is located above the left side. In other embodiments, the left side is located above the right side.
[0128] In some embodiments, the device is made of or comprises a material selected from the group consisting of stainless steel or its alloys, titanium or its alloys, magnesium or its alloys, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, xenograft biomaterials, and combinations thereof.
[0129] In a ninth aspect, the present disclosure features the device of the seventh or eighth aspect preloaded into a funnel.
[0130] In a tenth aspect, the present disclosure features a system including the device of the seventh or eighth aspect connected to a connector. In some embodiments, the device is preloaded into the funnel.
[0131] In an eleventh aspect, the disclosure features a method of bone repair that includes inserting a device of the seventh aspect or the eighth aspect into a bone.
[0132] In some embodiments, prior to inserting the device into the bone, the method includes drilling a hole in the bone, and the inserting includes depositing the device in the hole.
[0133] In some embodiments, the method further comprises expanding or compressing the device.
[0134] In some embodiments, the method further comprises inserting the device into a funnel.
[0135] In some embodiments, the method further comprises compressing the device by inserting the device into a funnel.
[0136] In some embodiments, prior to or after inserting the device into the funnel, the method further comprises aligning the funnel with a hole in the bone.
[0137] In some embodiments, before or after insertion of the device into the funnel, the method further comprises reversibly connecting the funnel to a proximal end of the device.
[0138] In some embodiments, the method further comprises inserting the device through the funnel and into a hole in the bone, the device expanding as or when it exits the funnel.
[0139] In some embodiments, the method further includes introducing a biomaterial into an interior channel of the device after expansion of the expandable body.
[0140] In some embodiments, prior to or after insertion of the device into the bone, the method further includes inserting a connector into an internal channel at a proximal region of the device, the connector comprising a frusto-conical shape having a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region, wherein a) the proximal region comprises a Luer lock thread, and b) the distal region of the connector comprises a plurality of circumferentially arranged, radially extending wedges.
[0141] In some embodiments, the method includes fastening a connector to an internal channel at a proximal region of the device after the device is inserted into the bone and after the proximal region of the device is anchored in the bone.
[0142] In some embodiments, the connector further comprises an alignment marker.
[0143] In some embodiments, the method further includes coupling a biomaterial dispenser containing the biomaterial to the connector using a luer lock thread.
[0144] In some embodiments, the biomaterial dispenser comprises a syringe, vial, or reservoir, and optionally the syringe, vial, or reservoir comprises a tube.
[0145] In some embodiments, the method includes introducing a volume of about 1 ml to about 20 ml (e.g., about 1 ml to about 2 ml, about 1 ml to about 3 ml, about 1 ml to about 4 ml, about 1 ml to about 5 ml, about 1 ml to about 10 ml, about 5 ml to about 10 ml, about 5 ml to about 15 ml, about 10 ml to about 15 ml, about 15 ml to about 20 ml, or about 15 ml to about 20 ml) of the biomaterial into an interior channel of the device.
[0146] In some embodiments, the volume of the biomaterial is about 2.5 ml, about 5 ml, or about 10 ml.
[0147] In some embodiments, the biomaterial comprises a polymer adhesive, a bone void filling material, a cement, a phosphoserine-based bioadhesive, a cohesive agent, a bone forming agent, a drug, or a pharmaceutical agent.
[0148] In some embodiments, the biomaterial is a calcium phosphate based bone cement, a non-self-setting calcium phosphate based bone void filler, a flowable xenograft bone void filler, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(alpha-hydroxy acid), a poly(lactone), a poly(amino acid), a poly(anhydride), a poly(orthoester), a poly(anhydride-co-imide), a poly(orthocarbonate), a poly(alpha-hydroxyalkanoate), a poly(dioxanone), a poly(phosphoester), a poly(L-lactide) (PLLA), a poly(D,L-lactide) (PDLLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a poly(L-lactide-co-D,L-lactide), a poly(D,L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(ε-caprolactone), poly(δ-valerolactone), poly(γ-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fiber, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide), block copolymer, poly(ethylene terephthalate) polyamide, potassium acrolein, (meth)acrylamide, homopolymer or copolymer containing one or more monomers selected from the group consisting of (meth)acrylic acid and salts thereof, (meth)acrylate, acrylonitrile, ethylene, ethylene glycol, ethyleneimine, ethylene oxide oxide, styrene sulfonate, vinyl acetate, vinyl alcohol, vinyl chloride, vinyl pyrrolidone, gallotannins, ellagitannins, taragallotannins, caffetannins, proanthocyanidins, catechin, epicatechin, chlorogenic acid, and arbutin, polyphenol complexing agents selected from alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethyl chitosan, de xtran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, cellulose, glucosamine, proteoglycan, starch, lactic acid, pluronic, sodium glycerophosphate, collagen, glycogen, keratin, silk, transforming growth factor-beta (TGF-β), activin, inhibin, bone morphogenetic protein (BMP), antibiotics, enzyme inhibitors, antihistamines, anti-inflammatory agents, muscle relaxants, antispasmodics, analgesics, prostaglandins, antidepressants, nutritional factors, or hormones.
[0149] In some embodiments, the method further includes separating the biomaterial dispenser and / or connector from the proximal region of the device after the biomaterial is introduced into the internal channel of the device.
[0150] In some embodiments, the method further comprises distributing the biomaterial evenly throughout the device and into the bone surrounding the device.
[0151] In some embodiments, the method further includes separating the biomaterial dispenser and / or connector from the proximal region of the device after the biomaterial is introduced into the internal channel of the device.
[0152] In some embodiments, the biomaterial hardens, thereby anchoring the device to the bone.
[0153] In some embodiments, the method further includes inserting a screw including a length through an internal channel of the device (eg, before or after hardening of the biomaterial).
[0154] In some embodiments, the method further includes aligning the screw with the internal protrusion or thread.
[0155] In some embodiments, the length of the screw traverses the length of the internal channel of the device, and the method further includes fastening a distal end of the screw to a distal cortex of the bone, and optionally, tightening the screw within the distal cortex causes bone compression.
[0156] In some embodiments, tightening the screw in the distal cortex does not cause rotation of the device.
[0157] In a twelfth aspect, the disclosure features a method of extracting the device of the seventh or eighth aspect from a bone, the method including: a) inserting a distal region of an extraction tool into an internal channel of the device, and c) twisting the extraction tool and removing the device from the bone. In some embodiments, twisting the extraction tool causes rotation of the device.
[0158] In some embodiments, the method further comprises: a) twisting the extraction tool clockwise to remove the device from the bone; or b) twisting the extraction tool counterclockwise to remove the device from the bone.
[0159] In some embodiments, prior to extracting the device, the method includes removing the screw from the device.
[0160] In a thirteenth aspect, the disclosure features a kit for treating a bone defect, the kit including the device of the seventh aspect or the eighth aspect.
[0161] In some embodiments, the kit further comprises one or more of a) an insertion tool, b) an extraction tool, c) a funnel, d) a connector, e) a screw or suture anchor, f) a washer, g) a container containing a biomaterial, h) a biomaterial dispenser, and i) a bone plate.
[0162] In some embodiments, the kit further includes a connector, the connector comprising a frusto-conical shape with a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region, wherein a) the proximal region includes a Luer lock thread, and b) the distal region of the connector includes a plurality of circumferentially arranged, radially extending wedges.
[0163] In some embodiments, the kit further comprises a screw, the screw comprising a length sufficient to traverse the length of the device.
[0164] In some embodiments, the screw comprises: a) a screw head; b) a diameter of about 1 mm to about 20 mm; c) a length of about 5 mm to about 300 mm; d) threads having a thread pitch of about 0.25 mm to about 2.5 mm; e) a non-threaded body; or f) a material selected from the group consisting of stainless steel or alloys thereof, titanium or alloys thereof, magnesium or alloys thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, a ceramic composite, a copper-based material or composite, cobalt chromium, and combinations thereof.
[0165] In some embodiments, the kit further includes a washer having a proximal region, a distal region, and an internal channel extending longitudinally through the proximal and distal regions of the washer, the washer being sized to fit within the internal channel of the proximal region of the device.
[0166] In some embodiments, a) the proximal region of the washer comprises an outer diameter of about 5 mm to about 30 mm, b) the proximal region of the washer comprises an inner diameter of about 2 mm to about 20 mm, c) the distal region of the washer comprises an outer diameter of about 2.8 mm to about 19.8 mm, d) the distal region of the washer comprises an inner diameter of about 2 mm to about 20 mm, and / or e) the outer diameter of the proximal region of the washer is greater than the outer diameter of the distal region of the washer.
[0167] In some embodiments, the kit further comprises a biological material.
[0168] In some embodiments, the biomaterial comprises a polymer adhesive, a bone void filling material, a cement, a phosphoserine-based bioadhesive, a cohesive agent, a bone forming agent, a drug, or a pharmaceutical agent.
[0169] In some embodiments, the biomaterial is a calcium phosphate based bone cement, a non-self-setting calcium phosphate based bone void filler, a flowable xenograft bone void filler, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(alpha-hydroxy acid), a poly(lactone), a poly(amino acid), a poly(anhydride), a poly(orthoester), a poly(anhydride-co-imide), a poly(orthocarbonate), a poly(alpha-hydroxyalkanoate), a poly(dioxanone), a poly(phosphoester), a poly(L-lactide) (PLLA), a poly(D,L-lactide) (PDLLA), a polyglycolide (PGA), a poly(lactide-co-glycolide) (PLGA), a poly(L-lactide-co-D,L-lactide), a poly(D,L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(ε-caprolactone), poly(δ-valerolactone), poly(γ-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fiber, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide), block copolymer, poly(ethylene terephthalate) polyamide, potassium acrolein, (meth)acrylamide, homopolymer or copolymer containing one or more monomers selected from the group consisting of (meth)acrylic acid and salts thereof, (meth)acrylate, acrylonitrile, ethylene, ethylene glycol, ethyleneimine, ethylene oxide oxide, styrene sulfonate, vinyl acetate, vinyl alcohol, vinyl chloride, vinyl pyrrolidone, gallotannins, ellagitannins, taragallotannins, caffetannins, proanthocyanidins, catechin, epicatechin, chlorogenic acid, and arbutin, polyphenol complexing agents selected from alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethyl chitosan, de xtran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, cellulose, glucosamine, proteoglycan, starch, lactic acid, pluronic, sodium glycerophosphate, collagen, glycogen, keratin, silk, transforming growth factor-beta (TGF-β), activin, inhibin, bone morphogenetic protein (BMP), antibiotics, enzyme inhibitors, antihistamines, anti-inflammatory agents, muscle relaxants, antispasmodics, analgesics, prostaglandins, antidepressants, nutritional factors, or hormones.
[0170] In some embodiments, the kit further comprises a biomaterial dispenser.
[0171] In some embodiments, the biomaterial dispenser includes a tube connected to a syringe, vial, or reservoir, and optionally the tube further contains the biomaterial.
[0172] In some embodiments, the kit further comprises a bone plate.
[0173] In some embodiments, the bone plate includes two or more bone plate holes.
[0174] In some embodiments, the kit further comprises a suture anchor, optionally the suture anchor is a soft tissue suture anchor. In some embodiments, the kit further comprises an intramedullary nail. In some embodiments, the kit further comprises a nail device. In some embodiments, the kit further comprises a spinal attachment device. The suture anchor, intramedullary nail, nail device, and / or spinal attachment device may be made from a material selected from the group consisting of stainless steel or alloys thereof, titanium or alloys thereof, magnesium or alloys 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. The suture anchor, intramedullary pin, nail device, and / or spinal attachment device may also be 3D printed using these materials or others.
[0175] definition In order to facilitate understanding of the present disclosure, some terms are defined below. Terms defined herein have the meanings generally understood by those skilled in the art to which the present disclosure pertains. Terms such as "a", "an" and "the" are not intended to refer to a singular entity only, but include a general class of which a specific example may be used for illustration. Terms in this specification are used to describe certain embodiments of the present disclosure, but their use does not limit the present disclosure, except as outlined in the claims.
[0176] As used herein, the term "about" refers to a value within 10% above or below the stated value.
[0177] As used herein, any value provided in a range of values includes both the upper and lower limits, as well as any value subsumed within the upper and lower limits.
[0178] The term "biomaterial" as used herein refers to any adhesive biocompatible substance of natural or synthetic origin that is suitable for introduction into living tissue for medical purposes (e.g., therapeutic, diagnostic, or prophylactic applications) and used to fill voids and fix, join, treat, heal, or regenerate bone.
[0179] The term "bone defect" as used herein refers to any bone defect area (e.g., a void, gap, recess, or other discontinuity in bone). Bone defects can be established artificially or naturally and can occur due to, for example, disease or trauma. Thus, bone defects can occur as a result of pathological or inflammatory diseases, the formation and / or removal of bone tumors, surgical intervention, congenital defects, or fractures, etc. For example, in the case of certain diseases such as bone tumors, bone defects can be established artificially by removal of tumor tissue. The screws of the present disclosure can be applied, for example, to the repair of periodontal defects, craniofacial or maxillofacial surgery or reconstruction, hand surgery, joint reconstruction, fracture repair, orthopedic surgery, and spinal fixation. The term "bone defect" is also intended to include anatomical sites where an enhancement to bone features is desired by a patient in the absence of disease or trauma, for example, in elective cosmetic surgery. Thus, a "defect" can be subjectively perceived by a patient, and an enhancement of the bone defect area is desired.
[0180] As used herein, the term "elongated slit" refers to an opening that has a substantially larger size in one dimension (e.g., length, height, or width) compared to the size of the opening in another dimension (e.g., length, height, or width).
[0181] As used herein, the term "milling flute" refers to one or more cutting edges that cut pieces of material (e.g., bone tissue) as the milling flute rotates. The milling flute may be a cutting protrusion integral with the device of the present disclosure.
[0182] As used herein, the term "mesh" refers to a structure characterized by having one or more openings arranged parallel, diagonally, perpendicular, spirally, or helically relative to the longitudinal axis of the device.
[0183] The term "opening" as used herein refers to any orifice, opening, void, gap, or hole that is characterized by the absence of a particular material or structure that defines the area of the device in which it is disposed. An "opening" may be circular or may take on any overall shape or geometric form that is outlined by edges that define the boundaries of the opening.
[0184] "Treating" or "treatment" refers to the medical management of a patient with the intent to result in the improvement, repair, or prevention of an injury or disease, pathological condition, or disorder. The term includes active treatment, i.e., treatment specifically directed to the improvement of the injury or disease, pathological condition, or disorder, and also includes causal treatment, i.e., treatment directed to the removal of the cause of the injury or disease, pathological condition, or disorder. In addition, the term includes symptomatic treatment, i.e., treatment designed for the relief of symptoms rather than a cure of the injury or disease, pathological condition, or disorder, prophylactic treatment, i.e., treatment directed to the prevention of the injury or disease, pathological condition, or disorder, and supportive treatment, i.e., treatment used to supplement another specific therapy directed to the improvement of the injury or disease, pathological condition, or disorder.
[0185] As used herein, the term "one-piece" refers to an undivided body that is of one-piece construction (e.g., a one-piece body that can be 3D printed in its entirety). [Brief description of the drawings]
[0186] [Figure 1] FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100 having a proximal region 101, a central region 126, and a distal region 151. The expandable body 130 of the central region 126 is also shown. [Diagram 2] FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100. The proximal region 101 is shown including wings 105. The distal region 151 is shown including milling flutes 175. Also shown is an expandable body 130 having a plurality of slits 140. [Diagram 3] FIG. 1 is a schematic diagram showing a close-up of the proximal region 101 of the device 100. The proximal region 101 is shown with wings 105. The proximal and distal ends 106, 107 of the proximal region 101 are also shown. The proximal ends 106 of the wings 105 are shown angled outward in the uncompressed state. The proximal opening 103 is also shown. [Figure 4] FIG. 1 is a schematic diagram showing a close-up of a central region 126 of device 100. Slits in central region 126 are also shown circumscribing the periphery of central region 126. Optional longitudinal grooves 150 along the longitudinal axis of device 100 are also shown. [Diagram 5] FIG. 1 is a schematic diagram showing a close-up view of the distal region 151 of the device 100. In this embodiment, four milling flutes 175 are shown with four notches 183 between the flutes. [Figure 6] 1 is a schematic diagram showing a cross-sectional view of the distal region 151 of the device 100. In this embodiment, a notch 183 is shown along with internal threads 160 disposed on the inner surface of the distal region 151. [Figure 7] FIG. 2 is a schematic diagram illustrating an embodiment of a tool insertion 200. A handle 215 is shown disposed on a proximal region 210 of the tool insertion 200. A central region 220 of the tool insertion 200 connects the proximal region 210 to a distal region 240. A lip 230 is positioned on the central region 220. An external thread 250 of the distal region 240 is also shown. [Figure 8A] FIG. 2 is a schematic diagram illustrating a cross-sectional view of an embodiment of a tool insertion 200 that does not have an internal channel. [Figure 8B] FIG. 2 is a schematic diagram illustrating a cross-sectional view of an embodiment of an insertion tool 200 including an internal channel 280 that traverses longitudinally from a proximal region to an insertion into a distal region. [Figure 9A] FIG. 1 is a schematic diagram showing a side view of device 100 engaged with a distal region of insertion tool 200. The distal region of insertion tool 200 is shown traversing the internal channel 190 (not shown) of device 100 from the proximal region 101 to the distal region 151. The male threads 250 of insertion tool 200 are engaged with the female threads 160 of the distal region 151 of device 100. The lip 230 of insertion tool 200 is shown contacting device 100 at the proximal region 101. [Figure 9B] FIG. 9A is a schematic diagram showing a cross-sectional view of the device 100 of FIG. 9A engaged with an insertion tool 200. The insertion tool 200 is shown traversing the internal channel 190 (not shown) of the device 100 from the proximal region 101 to the distal region 151 (label shown in FIG. 9A ). The male threads 250 of the insertion tool 200 are engaged with the female threads 160 of the distal region of the device 100. The lip 230 of the insertion tool 200 is shown contacting the device 100 at the proximal region 101. [Figure 10] FIG. 6 is a schematic diagram showing a side view of the screw 600, bone plate 800, and device 100. [Figure 11] FIG. 1 is a schematic diagram showing a perspective view of a screw 600 being inserted into the device 100, with a bone plate 800 disposed between the screw 600 and the device 100. The screw 600 is configured to be inserted into a hole in the bone plate 800 and then into the internal channel 190 of the device 100 at the proximal opening 103. [Figure 12] FIG. 6 is a schematic diagram illustrating a perspective view of a screw 600 configured to be inserted into a device 100 with a bone plate 800 disposed between the screw 600 and the device 100. [Figure 13A] FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100 in contact with a bone plate 800. [Figure 13B]FIG. 1 is a schematic diagram showing a cross-sectional view of an embodiment of the device 100 in contact with a bone plate 800. The holes in the bone plate 800 are shown to have a conical shape. [Figure 13C] 1 is a schematic diagram showing a side view of an embodiment of a device 100, a screw 600, and a bone plate 800. The screw 600 is inserted through the bone plate 800 and traverses the length of the internal channel 190 of the device 100. [Figure 13D] FIG. 1 is a schematic diagram showing a cross-sectional view of an embodiment of device 100, screw 600, and bone plate 800. Screw 600 is inserted through bone plate 800 and traverses the length of interior channel 190 of device 100. Screw head 675 is shown in contact with bone plate 800. [Figure 14A] FIG. 1 is a schematic diagram showing an enlarged side view showing the distal and central regions of an embodiment of device 100 engaged with screw 600. [Figure 14B] FIG. 14B is a schematic diagram showing a cross-sectional view of the device 100 and screw 600 shown in FIG. 14A. [Figure 14C] FIG. 1 is a schematic diagram showing an enlarged side view showing the distal and proximal regions of an embodiment of the device 100 and screw 600. The screw 600 traverses the length of the internal channel 190 of the device 100 and exits through the distal opening 155 of the device 100. The dashed arrow points in the direction of the bone. [Figure 14D] FIG. 14D is a schematic diagram showing a cross-sectional view of the device 100 and screw 600 shown in FIG. 14C. [Figure 15] FIG. 1 is a schematic diagram showing a side view of an embodiment of the device 100, washer 700, and screw 600. The proximal region 101, expandable body, and distal region 151 of the device 100 are shown. [Figure 16] FIG. 16 is a schematic diagram showing a perspective view of the device 100, washer 700, and screw 600 of FIG. Shown are the proximal region 725, distal region 750, and interior channel 775 of the washer 700. Also shown are the proximal region 101, expandable body 130, and distal region 151 of the device 100. [Figure 17]FIG. 16 is a schematic diagram showing a perspective view of the device 100, washer 700, and screw 600 of FIG. Shown are the proximal region 725, distal region 750, and interior channel 775 of the washer 700. Also shown are the proximal region 101, expandable body 130, and distal region 151 of the device 100. [Figure 18A] FIG. 1 is a schematic diagram showing a side view of a system 1000 of the present disclosure, including a tool insertion 200, a pusher 300, a connector 400, and a device 100. The threads in the distal region 240 of the tool insertion 200 are engaged with the internal threads 160 in the distal region 151 of the device 100. The pusher 300 is shown connected to the tool insertion 200 and in contact with the connector 400. [Figure 18B] 18B is a schematic diagram showing an enlarged cross-sectional view of the system 1000 shown in FIG. The threads at the distal region 240 of the insertion tool 200 are engaged with the internal threads 160 at the distal region 151 of the device 100. The pusher 300 is shown connected to the insertion tool 200 and in contact with the connector 400. [Figure 19A] FIG. 7 is a schematic diagram showing a side view of the distal region 151, the central region 126, and the proximal region 101 of the device 100. A washer 700 is shown inserted into the internal channel 190 of the device 100 in the proximal region 101. [Figure 19B] 19B is a schematic diagram showing a cross-sectional view of the distal region 151, the central region 126, and the proximal region 101 of the device 100 shown in Figure 19A. A washer 700 is shown inserted into the internal channel 190 of the device 100 in the proximal region 101. [Figure 19C] FIG. 1 is a schematic diagram showing a side view of device 100 with screw 600 inserted through internal channel 190 of device 100 and washer 700 residing within internal channel 190 of device 100 at proximal region 101. Screw head 675 contacts washer 700. [Figure 19D]19C is a schematic diagram showing a cross-sectional view of device 100 with screw 600 inserted through internal channel 190 of device 100 and washer 700 inserted into proximal region 101 of device 100. Screw head 675 is shown in contact with washer 700. [Figure 20A] FIG. 1 is a schematic diagram showing a side view of device 100 with screw 600 having a non-threaded body 650 inserted through internal channel 190 of device 100. Screw head 675 is in contact with washer 700. [Figure 20B] 20B is a schematic diagram showing a cross-sectional view of the device 100 of FIG. 20A showing a screw with a non-threaded body 650 inserted through the internal channel 190 of the device 100. The screw head 675 is shown in contact with a washer 700. [Figure 21] FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100 including a proximal region 101, a central region 126, a distal region 151, and a distal region opening 188. [Figure 22] 22 is a schematic diagram showing a perspective view of the distal region 151 of the device 100 of FIG. 21, illustrating a plurality of openings 188 in the distal region 151. FIG. [Diagram 23] 22 is a schematic diagram showing a cross-sectional view of the distal region 151 of the device 100 of FIG. 21, illustrating a plurality of openings 188 in the distal region 151. FIG. [Figure 24A] FIG. 1 is a schematic diagram showing a side view of an embodiment of device 100 engaged with insertion tool 200 (only the distal region of insertion tool 200 is shown). The distal region 240 of insertion tool 200 is shown traversing the internal channel 190 of device 100 from the proximal region 101 to the distal region 151. The male threads 250 of distal region 240 of insertion tool 200 are engaged with the female threads 160 of distal region 151 of device 100. Distal region 151 of device 100 is shown with a plurality of openings 188. [Figure 24B]24A engaged with an insertion tool 200. The insertion tool 200 is shown traversing the internal channel 190 of the device 100 from the proximal region 101 to the distal region 151. The male threads 250 of the insertion tool 200 are engaged with the female threads 160 of the distal region 151 of the device 100. [Figure 25A] 1 is a schematic diagram illustrating an embodiment of device 100 showing the unexpanded expandable body 130. The expandable body 130 is shown with two helical openings 140 with a width of 1.5 mm and a longitudinal groove 150. No torque is applied to device 100 and expandable body 130 is unexpanded. The displacement of expandable body 130 is 0 mm. [Figure 25B] FIG. 25B is a schematic diagram showing the device 100 of FIG. 25A after radial expansion of the expandable body 130 after application of a torque of 0.1 N·m. The expandable body 130 is shown with two helical openings 140 with a width of 1.5 mm. Expansion of the expandable body 130 occurs when the proximal region 101 of the device 100 is fixed to bone, rendering the proximal region 101 non-rotatable, while the distal region 151 is rotatable independently of the proximal region 101. By applying a torque to the distal region 151, the distal region 151 of the device 100 compresses towards the proximal region 101 and the expandable body 130 expands radially. The expandable body 130 is shown to have a displacement of 2.809 mm in response to the applied torque. [Figure 26A]FIG. 1 is a schematic diagram illustrating an embodiment of the device 100 with the expandable body 130 radially expanded. The expandable body 130 is shown without the longitudinal grooves 150. Expansion of the expandable body 130 occurs after a torque of 5 N·m is applied to the device 100 when the proximal region 101 of the device 100 is anchored to bone, rendering the proximal region 101 non-rotatable while the distal region 151 is rotatable independently of the proximal region 101. By applying a torque to the distal region 151, the distal region 151 of the device 100 compresses towards the proximal region 101 and the expandable body 130 expands radially. The expandable body 130 is shown to have a displacement of 5.048 mm in response to the applied torque. [Figure 26B] FIG. 1 is a schematic diagram showing the device 100 with the expandable body 130 radially expanded. The expandable body 130 is shown with longitudinal grooves 150. Expansion of the expandable body 130 occurs after a torque of 5 N·m is applied to the device 100 when the proximal region 101 of the device 100 is anchored to bone, rendering the proximal region 101 non-rotatable while the distal region 151 is rotatable independently of the proximal region 101. By applying a torque to the distal region 151, the distal region 151 of the device 100 compresses towards the proximal region 101 and the expandable body 130 expands radially. The expandable body 130 is shown to have a displacement of 5.092 mm in response to the applied torque. [Figure 27A] 1 is a schematic diagram illustrating an embodiment of a device 100 having an expandable body 130. No torque is applied to the device 100 and the expandable body 130 is not expanded. The displacement of the expandable body 130 is 0 mm. Four spiral openings 140 of the expandable body 130 are present in the central region 126 of the device 100. Each of the spiral openings 140 has a width of 0.75 mm. [Figure 27B]FIG. 27B is a schematic diagram showing the device 100 of FIG. 27A with the expandable body 130 radially expanded after application of a torque of 0.1 N·m to the device 100. Anchoring the proximal region 101 of the device 100 to bone renders the proximal region 101 non-rotatable, while the distal region 151 is rotatable independently of the proximal region 101. By applying a torque to the distal region 151, the distal region 151 of the device 100 compresses toward the proximal region 101 and the expandable body 130 radially expands. The expandable body 130 is shown to have a displacement of 3.894 mm in response to the applied torque. Each of the four helical openings 140 of the expandable body 130 has a width of 0.75 mm. [Figure 28A] 1 is a schematic diagram illustrating an embodiment of a device 100 having an expandable body 130. No torque is applied to the device 100 and the expandable body 130 is not expanded. The displacement of the expandable body 130 is 0 mm. There are six spiral openings 140 of the expandable body 130 in the central region 126 of the device 100. Each of the spiral openings 140 has a width of 0.5 mm. [Figure 28B] FIG. 28B is a schematic diagram showing the device 100 of FIG. 28A with the expandable body 130 radially expanded after application of a torque of 0.1 N·m to the device 100. Anchoring the proximal region 101 of the device 100 to bone renders the proximal region 101 non-rotatable, while the distal region 151 is rotatable independently of the proximal region 101. By applying a torque to the distal region 151, the distal region 151 of the device 100 compresses toward the proximal region 101 and the expandable body 130 radially expands. The expandable body 130 is shown to have a displacement of 3.964 mm in response to the applied torque. Each of the six helical openings 140 of the expandable body 130 has a width of 0.5 mm. [Figure 29A]1 is a schematic diagram illustrating an embodiment of a device 100 having an expandable body 130. No torque is applied to the device 100 and the expandable body 130 is not expanded. The displacement of the expandable body 130 is 0 mm. There are twelve spiral openings 140 of the expandable body 130 in the central region 126 of the device 100. Each of the spiral openings 140 has a width of 0.25 mm. [Figure 29B] FIG. 29B is a schematic diagram showing the device 100 of FIG. 29A with the expandable body 130 radially expanded after application of a torque of 0.1 N·m to the device 100. Anchoring the proximal region 101 of the device 100 to bone renders the proximal region 101 non-rotatable, while the distal region 151 is rotatable independently of the proximal region 101. By applying a torque to the distal region 151, the distal region 151 of the device 100 compresses toward the proximal region 101 and the expandable body 130 radially expands. The expandable body 130 is shown to have a displacement of 4.065 mm in response to the applied torque. Each of the twelve spiral openings 140 of the expandable body 130 has a width of 0.25 mm. [Figure 30A] FIG. 1 is a schematic diagram showing a side view of an embodiment of the device 100 with the expandable body 130 radially expanded, which occurs after applying a torque of 5 N·m to the distal region 151 of the device 100. The two spiral openings 140 of the expandable body 130 have a width of 1.5 mm, and the expandable body 130 is radially displaced by 5.092 mm. [Figure 30B] FIG. 1 is a schematic diagram illustrating a side view of an embodiment of a device 100 with a radially expanded expandable body 130 resulting in response to application of a torque of 5 N·m to a distal region 151 of the device 100. The twelve helical openings 140 of the expandable body 130 have a width of 0.25 mm, and the expandable body 130 is radially displaced by 5.348 mm. [Figure 31A]FIG. 9 is a schematic diagram showing an extraction tool 900 having a proximal region 910, a central region 920, and a distal region 930. The proximal region 910 has a gripping handle 915, the central region 920 includes a pivot joint 925, and the distal region 930 includes a pair of nubs 935, such that the extraction tool 900 is comprised of two members pivotally joined by the pivot joint 925. The proximal regions 910 of the two members form the gripping handle 915. The distal region 930 of each member includes a nub. [Figure 31B] 31A showing a top view of the extraction tool 900 of FIG. 31A, showing the proximal region 910, the central region 920, and the distal region 930. The grip handle 915 and the nub 935 are shown. [Diagram 32] FIG. 1 is a schematic diagram showing a side view of an extraction tool 900 and device 100. The device 100 is shown with a notch 183 in the distal region 151. The grip handle 915 and nub 935 of the extraction tool 900 are shown. [Figure 33A] FIG. 1 is a schematic diagram illustrating an embodiment of device 100 showing proximal region 101, central region 126, and distal region 151 including notch 183. [Figure 33B] 33B is a schematic diagram showing a perspective view of the device 100 of FIG. 33A, showing the proximal region 101, the central region 126, and the distal region 151. Four notches 183 and the internal threads 160 are shown in the distal region 151. [Figure 34A] FIG. 1 is a schematic diagram showing a cross-sectional view of device 100 with an extraction tool 900 partially inserted into the internal channel 190 of device 100. [Figure 34B] FIG. 1 is a schematic diagram showing a cross-sectional view of device 100 having extraction tool 900 inserted into internal channel 190 such that nub 935 is engaged with notch 183 in distal region 151 of device 100. [Diagram 35] FIG. 1 is a schematic diagram illustrating a perspective view of an embodiment of device 100 showing proximal region 101, central region 126, and distal region 151, where distal region 151 is shown with four notches 183. An extraction tool 900 is shown partially inserted into interior channel 190 of device 100. [Diagram 36] FIG. 36 is a schematic diagram showing a perspective view of the device 100 of FIG. The extraction tool 900 is shown fully inserted into the internal channel 190 of the device 100, with the nub 935 engaged with the notch 183 in the distal region 151 of the device 100. [Figure 37] FIG. 1 is a schematic diagram illustrating an embodiment of device 100 showing proximal region 101, central region 126, and distal region 151. The distal region has two notches 183 at the end of distal region 151 and two internal notches 183 in distal region 151. Distal region 151 is shown with two notches 183 disposed at the distal end of distal region 151 and two notches 183 disposed centrally within distal region 151. [Figure 38] FIG. 38 is a schematic diagram illustrating a perspective view of the device 100 of FIG. 37 showing the insertion of an extraction tool 900 into the internal channel 190. As shown, a nub 935 of the extraction tool is engaged with a centrally disposed internal notch 183 in the distal region of the device 100. [Figure 39] FIG. 38 is a schematic diagram illustrating a perspective view of the device 100 of FIG. 37 showing the insertion of an extraction tool 900 into the internal channel 190. As shown, a nub 935 of the extraction tool is engaged with a notch 183 disposed at a distal end in a distal region of the device 100. [Diagram 40] FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100 having a proximal region 101, a central region 126, and a distal region 151 having an external thread 165. [Diagram 41] FIG. 41 is a schematic diagram showing an enlarged perspective view of a portion of the distal and central regions of the device 100 of FIG. [Figure 42A] FIG. 41 is a schematic diagram showing an enlarged side view of a portion of the distal and central regions of the device 100 of FIG. 40, showing the male threads 165 and notch 183 in the distal region 151. [Figure 42B] 42B is a schematic diagram showing a cross-sectional view of the device 100 of Fig. 42A. The internal threads 160 of the device 100 in the distal region 151 are shown. [Diagram 43]FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100 having a proximal region 101, a central region 126, and a distal region 151 with a notch 183 having an elongated slit 185. [Diagram 44] FIG. 44 is a schematic diagram showing an enlarged perspective view of the device 100 of FIG. 43 with a portion of the central region 126 and the distal region 151. The distal region 151 is shown with a notch 183 and an elongated slit 185. The bendable tip 180 of the distal region 151 is also shown. [Diagram 45] FIG. 1 is a schematic diagram showing a side view of an embodiment of a device 100 having a proximal region 101, a central region 126, and a distal region 151. A connector 400 is fastened to an interior channel 190 at a proximal opening 103 of the device 100. The connector 400 is also connected to a tube 525, which is configured to deliver a biomaterial 550 to the interior channel 190 of the device 100. [Figure 46] FIG. 46 is a schematic diagram showing a perspective view of the device 100 of FIG. [Figure 47] 4 is a schematic diagram illustrating a side view of an embodiment of a connector 400. The connector 400 includes a proximal region 410, a distal region 430, a number of wedges 440, and a female luer lock thread disposed on the proximal region 410. [Figure 48] FIG. 48 is a schematic diagram showing a perspective view of the connector 400 of FIG. 47. [Figure 49] FIG. 48 is a schematic diagram showing a perspective view of the connector 400 of FIG. 47 inserted into the proximal opening 103 of the device 100. As shown, the connector 400 and the proximal region 101 are aligned using the alignment marker 125 of the device 100 and the alignment marker 420 of the connector 400. [Figure 50] FIG. 50 is a schematic diagram showing a proximal to distal view of the connector 400 and device 100 of FIG. 49. [Figure 51A] FIG. 4 is a schematic diagram showing a cross-sectional view of an embodiment of a device 100 engaged by a connector 400 and a distal region 240 of an insertion tool 200. The insertion tool 200 has male threads 250 at the distal region 240 that engage with the female threads 160 of the device 100. [Figure 51B] FIG. 2 is a schematic diagram showing a cross-sectional view of an embodiment of a device 100 engaged by a connector 400 and an insertion tool 200. The insertion tool 200 has male threads 240 at a distal region 240 that engage with the female threads 160 of the device 100. A lip 230 of a central region 220 of the lip of the insertion tool 200 is shown pressed against a proximal region 410 of the connector 400 to secure the connector 400 within the proximal opening 103 of the device 100. [Figure 52] 1 is a schematic diagram illustrating an embodiment of a device 100, a connector 400, an insertion tool 200, and a guidewire 290. The insertion tool 200 has an interior channel 280 extending longitudinally therethrough that is configured to direct a guidewire 290 from the proximal region 210 of the insertion tool 200 to a bone distal to the distal region 151 of the device 100. [Figure 53A] 4 is a schematic diagram illustrating a side view of an embodiment of a connector 400 having a proximal region 410 and a distal region 430. The connector 400 includes a circumferential groove 470 disposed in the distal region 430. [Figure 53B] FIG. 53B is a schematic diagram showing a perspective view of the connector 400 of FIG. 53A. [Figure 54] FIG. 1 is a schematic diagram showing a cross-sectional view of an embodiment of the device 100, the insertion tool 200, the connector 400, the bone plate 800, and the pusher 300. The male threads 250 of the insertion tool 200 are shown engaged with the female threads 160 of the device 100 at the distal region 151. The distal region 320 of the pusher 300 is shown in contact with the proximal region of the connector 400. The connector 400 has a circumferential groove 470 that fastens the connector 400 to the bone plate 800. Additionally, the connector 400 also includes a plurality of wedges 440 that secure the distal region 430 of the connector 400 to the internal channel 190 of the device 100 at the proximal region 101. [Figure 55]FIG. 2 is a schematic diagram illustrating an embodiment of a tool insertion 200. The tool insertion 200 is shown with a proximal region 210, a central region 220, and a distal region 240. The distal region 240 includes a first set of external threads 250 and a second set of external threads 260. The external threads 250 and 260 of the distal region 240 are separated by a non-threaded region 270 disposed therebetween. A handle 215 constitutes the proximal region 210 of the tool insertion 200. The central region 220 is an unthreaded shaft 225 having a diameter larger than the diameter of the distal region 240. The difference in diameter between the central region 220 and the distal region 240 creates a lip 230 of the tool insertion 200. [Figure 56] FIG. 3 is a schematic diagram illustrating an embodiment of a pusher 300 having a proximal region 310 and a distal region 320. The proximal region of the pusher 300 includes a handle 315. The distal region 320 of the pusher 300 is a shaft with a blunt end. The pusher 300 also has an internal channel 330 with internal threads 335. [Figure 57] FIG. 57 is a schematic diagram showing the insertion tool 200 of FIG. 55 engaged with the pusher 300 of FIG. 56. The distal region 240 of the insertion tool 200 is shown across the interior channel 330 of the pusher 300. The second set of external threads 260 of the insertion tool 200 are engaged with the internal threads 335 of the pusher 300. [Figure 58]FIG. 55 is a schematic diagram showing the insertion tool 200 of FIG. 55 engaged with the pusher 300 of FIG. 56 and the connector 400 of FIGS. 53A and 53B. The connector 400 is shown inserted onto the distal region 240 of the insertion tool 200 and in contact with the distal region 320 of the pusher 300. The pusher 300 is connected to the insertion tool 200 via engagement of the female threads 335 of the pusher 300 with the second set of male threads 260 of the insertion tool 200. Twisting the handle 315 of the pusher 300 allows the pusher 300 to rotate independently of the insertion tool 200, thereby translating the pusher 300 longitudinally towards the connector 400 and allowing the distal region 320 of the pusher 300 to contact the proximal region 410 of the connector 400. Continued twisting of the handle 315 of the pusher 300 pushes the connector 400 towards the distal end 202 of the insertion tool 200 . [Figure 59] FIG. 1 is a schematic diagram illustrating an embodiment of a system 1000 including an insertion tool 200, a pusher 300, a connector 400, and a device 100. Only the insertion tool 200 and the pusher 300 of the system 1000 are shown engaged. Also shown is a bone plate 800 and a bone with a pre-drilled bone hole. [Figure 60] FIG. 60 is a schematic diagram illustrating the system 1000 of FIG. 59, with the insertion tool 200, pusher 300, connector 400, and device 100 shown assembled. [Figure 61] 61 is a schematic diagram illustrating the use of the system 1000 of FIG. 60 to insert the device 100 into a bone through a hole in a bone plate 800. FIG. [Figure 62]As shown in FIG. 61 , which is a schematic diagram illustrating the use of the system 1000 after insertion of the device 100 into a bone, twisting of the pusher 300 pushes the connector 400 through a hole in the bone plate 800 such that the distal region 430 of the connector 400 enters the internal channel 190 at the proximal region 101 of the device 100 and allows the wedge 440 of the connector 400 to engage with the inside of the wings 105 of the device 100, thereby fixingly engaging the connector 400 to the device 100 and expanding the wings 105 into the bone. The expansion of the wings 105 locks the proximal region 101 of the device into the bone. Additionally, the circumferential groove 470 of the connector 400 engages the bone plate 800, thereby securing the connector 400 to the bone plate 800. [Figure 63] 63 is a schematic diagram showing the use of the system 1000, following the step shown in FIG. 62, in which twisting the handle 215 of the insertion tool 200 while holding the pusher 300 in contact with the connector 400 causes compression of the distal region 151 of the device 100, which causes the expandable body 130 of the central region 126 of the device 100 to radially expand due to the torque applied to the distal region 151 of the device 100 by the insertion tool 200. [Figure 64] FIG. 64 is a schematic diagram illustrating use of the system 1000 following the steps shown in FIG. 63. By twisting the handle 215 of the insertion tool 200 in a direction opposite to that shown in FIG. 63, the insertion tool 200 and pusher 300 are disengaged from the device 100 while the connector 300 remains engaged with the device 100. The expandable body 130 of the device 100 remains in a radially expanded state. [Figure 65] FIG. 65 is a schematic diagram showing the attachment of the tube 525 of the biomaterial dispenser 500 to the connector 400 via the Luer lock threads 415, following the step shown in FIG. 64, such that the biomaterial dispenser 500 is fluidly connected to the connector 400. [Figure 66]66 is a schematic diagram illustrating a step following that shown in Fig. 65, in which biomaterial 550 is introduced from biomaterial dispenser 500 into the internal channel 190 of device 100. Biomaterial 550 is delivered uniformly to the bone due to the radially expanded state of expandable body 130. [Figure 67] FIG. 67 is a schematic diagram showing a step following that shown in FIG. 66, in which the connector 400 and tube 525 of the biomaterial dispenser 500 have been detached from the device 100. [Figure 68] 68 is a schematic diagram illustrating a step subsequent to that shown in FIG. 67 showing the introduction of a screw 600 through a hole in a bone plate 800 and into an internal channel 190 of the device 100. FIG. [Figure 69] 69 is a schematic diagram showing a step following that shown in Fig. 68 where a screw 600 has been inserted into the device 100 and the screw 600 is anchored at its distal tip to bone. As the screw 600 is inserted into the device 100, the biomaterial 550 exits the expandable body 130 and is distributed into the bone around the device 100. [Figure 70A] 1 is a schematic diagram showing the proximal region 101 of the device 100 in an uncompressed state. The arrows indicate the proximal ends 106 of the wings 105 projecting outwardly from the proximal region 101 of the device 100. [Figure 70B] 1 is a schematic diagram showing the proximal region 101 of the device 100 in a compressed state. The arrows indicate the proximal ends 106 of the wings 105 deflected inwardly towards the proximal region 101 of the device 100. [Figure 71] FIG. 1 is a schematic diagram showing device 100 in the process of being inserted through hole 850 of bone plate 800. [Figure 72A] 1 is a schematic diagram showing device 100 in the process of being inserted through hole 850 in bone plate 800, which causes inward deflection (compression) of wings 105 at proximal end 106 of device 100. FIG. [Fig. 72B] FIG. 72B is a schematic diagram showing a cross-sectional view of the bone plate 800 of FIG. 72A. [Figure 73A]FIG. 8 is a schematic diagram showing device 100 after it has been fully inserted through bone plate 800. Once device 100 has passed through bone plate 800, wings 105 may return to an uncompressed / expanded (outwardly protruding) state. Engagement of a connector with proximal region 101 of device 100 can also be used to return wings 105 to an uncompressed / expanded state. [Figure 73B] FIG. 73B is a schematic diagram showing a cross-sectional view of the bone plate 800 of FIG. 73A. [Fig. 74A] FIG. 11 is a schematic diagram showing a side view of an embodiment of a device 1100 having a proximal region 1101, a central region 1126, and a distal region 1151. [Fig. 74B] FIG. 11 is a schematic diagram showing an isometric view of an embodiment of a device 1100 having a proximal region 1101, a central region 1126, and a distal region 1151. [Figure 75] FIG. 11 is a schematic diagram showing a cross-sectional view of an embodiment of a device 1100 having a proximal region 1101, a central region 1126, and a distal region 1151. An internal protrusion 1131 and an external protrusion 1132 are shown. [Figure 76] FIG. 11 is a schematic diagram showing an isometric view of an embodiment of a device 1100 having an internal protrusion 1131, an external protrusion 1132, and wings 1105. [Figure 77] FIG. 11 is a schematic diagram showing a side view of an embodiment of a device 1100 having a proximal region 1101, a central region 1126, and a distal region 1151, where the device 1100 has a screw 600 inserted into an internal channel 1190. [Fig. 78A] FIG. 1 is a schematic diagram showing a cross-sectional view of an embodiment of device 1100 being inserted into a funnel 1400. [Fig. 78B] FIG. 1 is a schematic diagram showing a cross-sectional view of an embodiment of device 1100 inserted into a funnel 1400. Compression of first section 1134 is shown, which is the expandable and / or compressible body of device 1100. [Fig. 78C] FIG. 11 is a schematic diagram showing a side view of an embodiment of a device 1100 having a screw 600 inserted into an internal channel 1190. [Figure 79] FIG. 1 is a schematic diagram showing a cross-sectional view of an embodiment of device 1100 being inserted into a funnel 1400. [Figure 80A] FIG. 15 is a schematic diagram showing a cross-sectional view of an embodiment of device 1100 with an uninflated balloon 1500 inserted therein. [Figure 80B] FIG. 15 is a schematic diagram showing a cross-sectional view of an embodiment of device 1100 with a partial balloon 1500 inserted therein. [Fig. 80C] A schematic diagram showing a cross-sectional view of an embodiment of a device 1100 having an inflated balloon 1500 inserted therein, where the expandable and / or compressible body of a first section 1134 of the device 1100 is expanded by the inflated balloon 1500. [Figure 81] FIG. 11 is a schematic diagram showing a side view of an embodiment of device 1100 with screw 600 inserted into device 1100 and anchored at its distal tip to bone. Upon insertion of screw 600 into device 1100, biomaterial 550 exits device 1100 and is distributed into the bone surrounding device 1100. [Fig. 82A] FIG. 12 is a schematic diagram showing a side view of an embodiment of a device 1200 having a proximal region 1201, a central region 1226, and a distal region 1251. [Fig. 82B] FIG. 12 is a schematic diagram showing an isometric view of an embodiment of a device 1200 having a proximal region 1201, a central region 1226, and a distal region 1251. [Figure 83A] FIG. 12 is a schematic diagram showing a cross-sectional view of an embodiment of a device 1200 having a proximal region 1201, a central region 1226, and a distal region 1251. [Figure 83B] FIG. 82B is a schematic diagram showing a cross-sectional view of an embodiment of the device 1200 of FIG. 82A. [Figure 84] FIG. 82B is a schematic diagram showing a close-up of central region 1226 of device 1200 of FIG. 82A. Opening 1240 and internal protrusion 1231 are shown. [Fig. 85A]FIG. 13 is a schematic diagram showing two cross-sectional views of an embodiment of device 1200 inserted into a funnel 1400 such that the right and left sides of device 1200 overlap. [Fig. 85B] FIG. 12 is a schematic diagram showing a perspective view and a cross-sectional view of an embodiment of device 1200 expanded such that the right and left sides of device 1200 do not overlap. [Fig. 85C] FIG. 12 is a schematic diagram showing a side view and a cross-sectional view of an embodiment of a device 1200 having a screw 600 inserted into an internal channel 1290. [Figure 86A] FIG. 13 is a schematic diagram showing a side view of an embodiment of a device 1300 having a proximal region 1301, a central region 1326, and a distal region 1351. [Figure 86B] FIG. 13 is a schematic diagram showing an isometric view of an embodiment of a device 1300. An external protrusion 1332 is shown. [Fig. 87A] 13 is a schematic diagram showing a cross-sectional view and a close-up view of an embodiment of device 1300. Internal protrusion 1331 is shown. [Fig. 87B] FIG. 13 is a schematic diagram showing a cross-sectional view of an embodiment of a device 1300. An internal protrusion 1331 is shown. [Figure 88] FIG. 13 is a schematic diagram showing an isometric view of an embodiment of a device 1300. An internal protrusion 1331 and an external protrusion 1332 are shown. [Figure 89] FIG. 13 is a schematic diagram showing a cross-sectional view of an embodiment of a device 1300. External protrusions 1332 are shown. [Figure 90A] FIG. 13 is a schematic diagram showing a close-up view of a central region of an embodiment of device 1300. The extendable arms 1392 are shown compressed. [Figure 90B] FIG. 13 is a schematic diagram showing a close-up view of a central region of an embodiment of device 1300. The extendable arm 1392 is shown extended. [Figure 91] FIG. 11 is a schematic diagram showing a cross-sectional view of a device 1100 having an internal protrusion 1131 and an external protrusion 1132. [Figure 92A] FIG. 13 is a schematic diagram showing an embodiment of a thread or protrusion formed from four protrusions per 360°. [Fig. 92B] FIG. 92B is a schematic diagram showing a cross-sectional view of the device of FIG. 92A, illustrating an embodiment of a thread formed from four protrusions per 360°. [Figure 93] FIG. 1 is a schematic diagram showing an embodiment of a thread formed from three grooves per 360°. [Figure 94] FIG. 1 is a schematic diagram showing an embodiment of a thread formed from four corrugations per 360°. [Figure 95] FIG. 13 is a schematic diagram illustrating an embodiment of a thread formed from a mesh. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0187] Detailed Description Featured herein are devices, systems, kits, and methods of use thereof for bone repair, bone stabilization, and / or implant fixation. In some embodiments, the devices, systems, and methods described herein are useful for treating bone defects (e.g., fractures) or for implant fixation, for example, by installing at least one of the devices described herein using the systems, kits, and / or methods described herein. In some embodiments, the devices, systems, kits, and methods can be used to deliver biomaterials to bone. The biomaterials can be used to repair bone defects, stabilize weak or deficient bone, or stabilize implanted hardware. The devices and methods described herein can be used to provide uniform biomaterial delivery to result in strong adhesion between implants (e.g., embedded screws) and bone tissue. Additionally, the devices and methods overcome challenges associated with repairing weak or defective bones and bone augmentation using injected biomaterials (e.g., biomaterials with non-Newtonian hydrodynamic properties).
[0188] Devices for bone repair The device of the present disclosure is an implant that can be used for multiple purposes, including repair of bone defects. The device is configured for insertion into bone (e.g., into a bone hole 875 that is pre-drilled into the bone prior to insertion of the device). Once inserted, the device can be used to uniformly deliver biomaterial to the bone, anchor bone structures, and promote bone repair and / or healing. The device can be used in combination with or to anchor other hardware, such as, for example, bone plates, soft tissue suture anchors, intramedullary nails, nails, screws, or other similar hardware, and spinal attachment devices.
[0189] Device itself The device has a unitary cylindrical body. The device includes an internal channel extending longitudinally through a proximal region, a central region, and a distal region. In some embodiments, the device includes a proximal region, a distal region, and a central region disposed therebetween.
[0190] The internal channel includes an inner surface. The inner surface may be smooth or may be rough, for example, including at least one internal protrusion. The internal channel may be straight, curvilinear, radial, or spiral, depending on the implantable device used with the device.
[0191] In some embodiments, the device has a diameter of about 9 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm, about 9 0mm~110mm, 95mm~110mm, 100mm~110mm, 105mm~110mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19 mm, approximately 20mm, approximately 21mm, approximately 22mm, approximately 23mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38 mm, approx. 39mm, approx. 40mm, approx. 41mm, approx. 42mm, approx. 43mm, approx. 44mm, approx. 45mm, approx. 46mm, approx. 47mm, approx. 48mm, approx. 49mm, approx. mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76 In some embodiments, the endoscopically coupled ...In some embodiments, the device has a length of more than 9 mm (e.g., more than 10 mm, more than 15 mm, more than 20 mm, more than 25 mm, more than 30 mm, more than 40 mm, more than 50 mm, more than 60 mm, more than 70 mm, more than 80 mm, more than 90, more than 100 mm, or more than 110 mm). In some embodiments, the device has a length of less than 110 mm (e.g., less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
[0192] In some embodiments, the device is made from or includes a material selected from the group consisting of stainless steel or its alloys, titanium or its alloys, magnesium or its alloys, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, xenograft biomaterials, and combinations thereof. The device can also be 3D printed using these or other materials.
[0193] Proximal region In some embodiments, the device includes a proximal region having a proximal end, a distal end, and a proximal opening to an internal channel.
[0194] In some embodiments, the proximal region has an outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm to about 8 mm, about 4 mm to about 10 mm, about 4 mm to about 15 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). In certain embodiments, the outer diameter of the proximal region is smaller, larger, or equal to the outer diameter of the central region.
[0195] In some embodiments, the proximal region has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the proximal region is smaller, larger, or equal to the inner diameter of the central region.
[0196] In some embodiments, the proximal region is about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 0.1 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 39 mm, about 30 mm, about 30 mm, about 31 mm, about 32 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 39 mm, about 30 ... m, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm in length.
[0197] In some embodiments, the proximal region is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm). In certain embodiments, the wall thickness of the proximal region is less than, greater than, or equal to the wall thickness of the central region.
[0198] In some embodiments, the proximal region 1301 includes 3 to 20 (e.g., 3 to 15, 4 to 10, 5 to 8, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) wings extending radially around the outer surface of the proximal region.
[0199] In some embodiments, the proximal end of the proximal region has a blunt edge. In some embodiments, the proximal end of the proximal region has a tapered edge. In some embodiments, the proximal end of the proximal region has at least one or more milling flutes, notches, bendable tips, and / or elongated tips.
[0200] In some embodiments, the proximal region has multiple openings (e.g., slits or perforations). In some embodiments, the proximal region has no openings other than the opening to the internal channel. In some embodiments, the device has no proximal region.
[0201] central area The device includes a central region having a proximal end and a distal end. In some embodiments, the central region is disposed between the proximal and distal regions. In some embodiments, the central region of the device includes an expandable and / or compressible body.
[0202] In some embodiments, the central region is about 1.25 mm to about 25 mm (e.g., about 1.25 mm to about 2 mm, about 1.25 mm to about 3 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 4 mm to about 8 mm, about 4 mm to about 10 mm, about 4 mm to about 15 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 25 mm to about 30 ... The central region has an outer diameter of about 20 mm to about 25 mm, about 1.5 mm, about 1.75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. The central region comprises an outer diameter that is less than, greater than, or equal to the outer diameter of the proximal and distal regions.
[0203] In some embodiments, the central region has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). The central region comprises an inner diameter that is smaller, larger, or equal to the inner diameters of the proximal and distal regions.
[0204] In some embodiments, the central region is about 5 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm, about 90mm~110mm, 95mm~110mm, 100mm~110mm, 105mm~110mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 1 9mm, about 20mm, about 21mm, about 22mm, about 23mm, about 24mm, about 25mm, about 26mm, about 27mm, about 28mm, about 29mm, about 30mm, about 31mm, about 32mm, about 33mm, about 34mm, about 35mm, about 36mm, about 37mm, about 3 8mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 5 7mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 7 In some embodiments, the endoscopic catheter has a length of about 6 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm.
[0205] In some embodiments, the central region is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, m, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm). In certain embodiments, the wall thickness of the central region is less than, greater than, or equal to the wall thickness of the proximal and distal regions.
[0206] In some embodiments, the central region includes a plurality of openings (eg, slits or perforations).
[0207] In some embodiments, the central region has between 2 and 20 (e.g., between 2 and 4, between 2 and 6, between 2 and 8, between 2 and 10, between 4 and 8, between 4 and 10, between 4 and 12, between 10 and 16, between 10 and 20, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) segments. In some embodiments, the segments of the central region are connected by multiple expandable arms. In some embodiments, the central region has 2 to 100 (e.g., 2 to 10, 2 to 20, 10 to 20, 10 to 30, 10 to 50, 20 to 40, 20 to 60, 40 to 80, 50 to 100, 60 to 80, 80 to 100, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 extendable arms.
[0208] In some embodiments, the central region includes i) a first section including an expandable and / or compressible body, and (ii) a second section including a plurality of openings. In some embodiments, the central region includes, from the proximal end to the distal end, i) the first section, and ii) the second section.The first section may be about 5 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm, about 90 mm ~110mm, 95mm~110mm, 100mm~110mm, 105mm~110mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm , about 20mm, about 21mm, about 22mm, about 23mm, about 24mm, about 25mm, about 26mm, about 27mm, about 28mm, about 29mm, about 30mm, about 31mm, about 32mm, about 33mm, about 34mm, about 35mm, about 36mm, about 37mm, about 38mm , approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57m m, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76m m, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm.The second section may be about 5 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm, about 90 mm ~110mm, 95mm~110mm, 100mm~110mm, 105mm~110mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm , about 20mm, about 21mm, about 22mm, about 23mm, about 24mm, about 25mm, about 26mm, about 27mm, about 28mm, about 29mm, about 30mm, about 31mm, about 32mm, about 33mm, about 34mm, about 35mm, about 36mm, about 37mm, about 38mm , approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57m m, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm in length.
[0209] Distal region In some embodiments, the device includes a distal region having a proximal end, a distal end, and a distal opening to an internal channel.
[0210] In some embodiments, the distal region has an outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm to about 5 mm, about 5 mm to about 15 mm, about 10 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). In certain embodiments, the outer diameter of the distal region is smaller, larger, or equal to the outer diameter of the central region.
[0211] In some embodiments, the distal region has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 2 mm to about 5 mm, about 4 mm to about 8 mm, about 5 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the distal region is smaller, larger, or equal to the inner diameter of the central region 1126.
[0212] In some embodiments, the distal region is about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 0.1 mm, about 0.5 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 ... m, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm in length.
[0213] In some embodiments, distal region 1251 is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, m, about 0.7 mm, about 0.8 mm, mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm). In certain embodiments, the wall thickness of the distal region is less than, greater than, or equal to the wall thickness of the central region 1126.
[0214] In some embodiments, the distal end of the distal region has a blunt edge. In some embodiments, the distal end of the distal region has a tapered edge. In some embodiments, the distal end of the distal region has at least one or more milling flutes, notches, bendable tips, and / or elongated tips.
[0215] In some embodiments, the distal region has multiple openings (e.g., slits or perforations). In some embodiments, the distal region has no openings other than the opening to the internal channel. In some embodiments, the device has no distal region.
[0216] Expandable and / or compressible body In some embodiments, the device has at least one expandable and / or compressible body configured to radially expand and / or compress, e.g., at least one body configured to both expand and compress, at least one expandable body configured to radially expand, and / or at least one compressible body configured to radially compress. The proximal region, the central region, and / or the distal region may include at least one expandable and / or compressible body. Alternatively, an expandable and / or compressible body may extend through at least two of the proximal region, the central region, and the distal region. For example, in some embodiments, one expandable and / or compressible body extends from the proximal end to the distal end of the device, i.e., the entire device is an expandable and / or compressible body.
[0217] In some embodiments, the expandable and / or compressible body comprises a flared or tapered shape. In some embodiments, the compressible body comprises a plurality of circumferentially disposed compressible wings. In some embodiments, the expandable and / or compressible body comprises a plurality of segments connected by a plurality of expandable arms.
[0218] In some embodiments, the expandable and / or compressible body comprises a mesh or mesh-like structure. In some embodiments, the mesh or mesh-like structure comprises a diamond, square, circular, woven, or elliptical opening pattern. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure comprises a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure comprises a wire gauge of 5 to 50 (eg, 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0219] In some embodiments, the expandable and / or compressible body is configured to expand and / or compress to allow for uniform distribution and delivery of biomaterial to the bone surrounding the device. In some embodiments, the expandable and / or compressible body is configured to expand and / or compress, thereby providing a volume for receiving biomaterial that can be delivered to the bone through the expandable body. In some embodiments, the expandable body has a volume of about 1 ml to about 20 ml (e.g., about 1 ml to about 2 ml, about 1 ml to about 3 ml, about 1 ml to about 4 ml, about 1 ml to about 5 ml, about 1 ml to about 10 ml, about 5 ml to about 10 ml, about 5 ml to about 15 ml, about 10 ml to about 15 ml, about 15 ml to about 20 ml, about 1 ml to about 2 ml, about 1 ml to about 3 ml, about 1 ml to about 4 ml, about 1 ml to about 5 ml, about 1 ml to about 10 ml, about 5 ml to about 10 ml, about 5ml to about 15ml, about 10ml to about 15ml, about 15ml to about 20ml, about 15ml to about 20ml, about 1ml, about 1.1ml, about 1.2ml, about 1.3ml, about 1.4ml, about 1.5ml, about 1.6ml, about 1.7ml, about 1. 8ml, about 1.9ml, about 2ml, about 2.1ml, about 2.2ml, about 2.3ml, about 2.4ml, about 2.5ml, about 2.6ml, about 2.7ml, about 2.8ml, about 2.9ml, about 3ml, about 3.1ml, about 3.2ml, about 3.3m l, about 3.4ml, about 3.5ml, about 3.6ml, about 3.7ml, about 3.8ml, about 3.9ml, about 4ml, about 4.1ml, about 4.2ml, about 4.3ml, about 4.4ml, about 4.5ml, about 4.6ml, about 4.7ml, about 4.8m l, about 4.9ml, about 5ml, about 5.1ml, about 5.2ml, about 5.3ml, about 5.4ml, about 5.5ml, about 5.6ml, about 5.7ml, about 5.8ml, about 5.9ml, about 6ml, about 6.1ml, about 6.2ml, about 6.3ml, Approximately 6.4ml, approximately 6.5ml, approximately 6.6ml, approximately 6.7ml, approximately 6.8ml, approximately 6.9ml, approximately 7ml, approximately 7.1ml, approximately 7.2ml, approximately 7.3ml, approximately 7.4ml, approximately 7.5ml, approximately 7.6ml, approximately 7.7ml, approximately 7.8ml, Approximately 7.9ml, approximately 8ml, approximately 8.1ml, approximately 8.2ml, approximately 8.3ml, approximately 8.4ml, approximately 8.5ml, approximately 8.6ml, approximately 8.7ml, approximately 8.8ml, approximately 8.9ml, approximately 9ml, approximately 9.1ml, approximately 9.2ml, approximately 9.3ml, approximately 9.It can expand to a volume of 4 ml, about 9.5 ml, about 9.6 ml, about 9.7 ml, about 9.8 ml, about 9.9 ml, about 10 ml, about 11 ml, about 11.1 ml, about 11.2 ml, about 11.3 ml, about 11.4 ml, about 11.5 ml, about 11.6 ml, about 11.7 ml, about 11.8 ml, about 11.9 ml, about 12 ml, about 12.1 ml, about 12.2 ml, about 12.3 ml, about 12.4 ml, about 12.5 ml, about 12.6 ml, about 12.7 ml, about 12.8 ml, about 12.9 ml, about 13 ml, about 13.1 ml, about 13.2 ml, about 13.3 ml, about 13.4 ml, about 13.5 ml, about 13.6 ml, about 13.7 ml, about 13.8 ml, about 13.9 ml, about 14 ml, about 14.1 ml, about 14.2 ml, about 14.3 ml, about 14.4 ml, about 14.5 ml, about 14.6 ml, about 14.7 ml, about 14.8 ml, about 14.9 ml, about 15 ml, about 15.1 ml, about 15.2 ml, about 15.3 ml, about 15.4 ml, about 15.5 ml, about 15.6 ml, about 15.7 ml, about 15.8 ml, about 15.9 ml, about 16 ml, about 16.1 ml, about 16.2 ml, about 16.3 ml, about 16.4 ml, about 16.5 ml, about 16.6 ml, about 16.7 ml, about 16.8 ml, about 16.9 ml, about 17 ml, about 17.1 ml, about 17.2 ml, about 17.3 ml, about 17.4 ml, about 17.5 ml, about 17.6 ml, about 17.7 ml, about 17.8 ml, about 17.9 ml, about 18 ml, about 18.1 ml, about 18.2 ml, about 18.3 ml, about 18.4 ml, about 18.5 ml, about 18.6 ml, about 18.7 ml, about 18.8 ml, about 18.9 ml, about 19 ml, about 19.1 ml, about 19.2 ml, about 19.3 ml, about 19.4 ml, about 19.5 ml, about 19.6 ml, about 19.7 ml, about 19.8 ml, about 19.9 ml, or about 20 ml).
[0220] In some embodiments, the expandable and / or compressible body expands and / or compresses to lock the device in a first position. For example, following deployment of the device into a bone hole, the device may expand against the bone, thereby locking the device in a first position. Compression of the device may facilitate insertion of the device into the bone. For example, compression of the compressible body facilitates loading of the device into a delivery device, such as a funnel or equivalent device. The device in a compressed form can be delivered / pushed (e.g., by using a pusher or obturator) through the delivery device until the device is fully inserted into the bone hole. Once the device exits the delivery device and is fully or at least partially inserted into the bone, the device can return to a non-compressed state. If desired, the device can then be expanded in situ, for example, using an expansion tool (e.g., a balloon).
[0221] wing section In some embodiments, the device includes between 3 and 20 (e.g., between 3 and 15, between 4 and 10, between 5 and 8, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) wings extending radially around the outer surface of the device.
[0222] In some embodiments, the wings have a proximal end and a distal end. In some embodiments, the proximal end of the wings is positioned at the same location as the proximal end of the proximal region. In some embodiments, the distal end of the wings is about 2 mm to about 30 mm (e.g., about 2 mm to about 5 mm, about 2 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, about In one embodiment, the endoscopic imaging device is positioned at a distance of about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm.
[0223] In some embodiments, the wings have a rectangular shape having a length and a width. In some embodiments, all of the wings have substantially equal lengths and widths. In some embodiments, the wings have different lengths and widths. In some embodiments, the length of each wing is about 5 mm to about 20 mm (e.g., about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In some embodiments, the width of each wing is about 1 mm to about 15 mm (e.g., about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, or about 15 mm).
[0224] In some embodiments, the proximal ends of the wings are configured to protrude radially outward from the proximal region at an angle of about 2° to about 10° (e.g., about 2°, about 3°, about 4°, about 5°, about 6°, about 7°, about 8°, about 9°, or about 10°) in the uncompressed (expanded) state. In some embodiments, the proximal ends 106 of the wings are separated from the proximal region.
[0225] In some embodiments, a distal end of each wing is connected to the proximal region and configured to pivot the proximal end of the wing away from the proximal region, hi some embodiments, the wings are configured to reversibly flex inwardly toward an internal channel of the proximal region, thereby substantially eliminating outward protrusion of the proximal ends of the wings upon compression.
[0226] Segments and Extendable Arms In some embodiments, the body of the device comprises multiple longitudinal segments connected by multiple expandable arms. In some embodiments, the proximal region, the central region, and / or the distal region comprises at least one expandable arm. In some embodiments, the proximal region, the central region, and / or the distal region comprises multiple segments.
[0227] In some embodiments, the segments of the central region extend into the proximal region and / or the distal region, hi certain embodiments, the segments extend from the proximal end through the central region to the distal end.
[0228] The segments may be of various shapes and sizes, hi some embodiments, the segments comprise longitudinal segments.
[0229] In some embodiments, the segments are polygonal, circular, triangular, elliptical, cylindrical, or irregular, hi some embodiments, the longitudinal segments are rectangular and have a length from the proximal end to the distal end that is greater than their width.
[0230] The device, proximal region, central region, and / or distal region may include 2-20 (e.g., 2-4, 2-6, 2-8, 2-10, 4-8, 4-10, 4-12, 10-16, 10-20, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) segments. The device, proximal region, central region, and / or distal region may include 2-100 (e.g., 2-10, 2-20, 10-20, 10-30, 10-50, 20-40, 20-60, 40-80, 50-100, 60-80, or 80-100) expandable arms connecting the segments. In some embodiments, the device includes 1-50 (e.g., 1-5, 1-10, 4-8, 5-10, 8-12, 8-16, 10-15, 10-20, 20-30, 20-40, 30-40, or 40-50) expandable arms per segment. In some embodiments, the device includes 1-50 pairs of expandable arms.
[0231] In some embodiments, each of the segments are identical, hi some embodiments, each of the segments are separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 50 mm.
[0232] In some embodiments, each of the segments comprises a length of about 9 mm to about 110 mm.
[0233] In some embodiments, each of the segments comprises a width of about 0.1 mm to about 50 mm.
[0234] In some embodiments, the expandable arms are separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 50 mm. In some embodiments, pairs of expandable arms are separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 20 mm.
[0235] The expandable arms may be in a variety of shapes, hi some embodiments, the expandable arms are c-shaped, s-shaped, u-shaped, or z-shaped.
[0236] In some embodiments, the extendable arm may be non-releasably connected to the segment. In some embodiments, the extendable arm is releasably connected to the segment.
[0237] Rolled Surface In some embodiments, the device has a rolled surface with an internal channel extending longitudinally from a proximal end to a distal end, the rolled surface having a proximal side, a distal side, a left side, and a right side, where the left side and right side may or may not overlap when radially expanded.
[0238] In some embodiments, the rolled surface is about 9 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm, about 90mm~110mm, 95mm~110mm, 100mm~110mm, 105mm~110mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 1 9mm, about 20mm, about 21mm, about 22mm, about 23mm, about 24mm, about 25mm, about 26mm, about 27mm, about 28mm, about 29mm, about 30mm, about 31mm, about 32mm, about 33mm, about 34mm, about 35mm, about 36mm, about 37mm, about 3 8mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 5 7mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 7 In some embodiments, the endoscopic catheter has a length of about 6 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm.In some embodiments, the rolling surface has a length of more than 9 mm (e.g., more than 10 mm, more than 15 mm, more than 20 mm, more than 25 mm, more than 30 mm, more than 40 mm, more than 50 mm, more than 60 mm, more than 70 mm, more than 80 mm, more than 90, more than 100 mm, or more than 110 mm). In some embodiments, the rolling surface has a length of less than 110 mm (e.g., less than 100 mm, less than 90 mm, less than 80 mm, less than 70 mm, less than 60 mm, less than 50 mm, less than 40 mm, less than 30 mm, less than 20 mm, or less than 10 mm).
[0239] In some embodiments, the rolled surface may extend from about 9 mm to about 200 mm (e.g., about 10 mm to about 100 mm, about 20 mm to about 100 mm, about 25 mm to about 100 mm, about 30 mm to about 100 mm, about 35 mm to about 100 mm, about 40 mm to about 100 mm, about 45 mm to about 100 mm, about 50 mm to about 100 mm, about 50 mm to about 150 mm, about 50 mm to about 200 mm, about 55 mm to about 100 mm, about 60 mm to about 100 mm, about 65 mm to about 100 mm, about 70 mm to about 100 mm, about 75 mm to about 100 mm, about 80 mm to about 100 mm, about 85mm to about 100mm, about 90mm to about 100mm, about 95mm to about 100mm, about 100mm to about 125mm, about 100mm to about 150mm, about 100mm to about 200mm, about 105mm to about 110mm, about 150mm to about 200mm, about 9mm, about 10mm, about 11mm, Approximately 12mm, approximately 13mm, approximately 14mm, approximately 15mm, approximately 16mm, approximately 17mm, approximately 18mm, approximately 19mm, approximately 20mm, approximately 21mm, approximately 22mm, approximately 23mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm , about 33mm, about 34mm, about 35mm, about 36mm, about 37mm, about 38mm, about 39mm, about 40mm, about 41mm, about 42mm, about 43mm, about 44mm, about 45mm, about 46mm, about 47mm, about 48mm, about 49mm, about 50mm, about 51mm, about 52mm, about 53m m, approx. 54mm, approx. 55mm, approx. 56mm, approx. 57mm, approx. 58mm, approx. 59mm, approx. 60mm, approx. 61mm, approx. 62mm, approx. 63mm, approx. mm, approx. 75mm, approx. 76mm, approx. 77mm, approx. 78mm, approx. 79mm, approx. 80mm, approx. 81mm, approx. 82mm, approx. 83mm, approx. 84mm, approx. 5mm, approximately 96mm, approximately 97mm, approximately 98mm, approximately 99mm, approximately 100mm, approximately 101mm, approximately 102mm, approximately 103mm, approximately 104mm, approximately 105mm, approximately 106mm, approximately 107mm, approximately 108mm, approximately 109mm, approximately 110mm, approximately 120mm, approximately 130mm, approximately 140mm,The width of the casing is about 150 mm, about 160 mm, about 170 mm, about 180 mm, about 190 mm, or about 200 mm.
[0240] In an embodiment, the left and right sides overlap in the compressed (unexpanded) or uncompressed (expanded) state by about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 2 mm, about 0.1 mm to about 20 mm, about 0.5 mm to about 1 mm, 0.5 mm to about 2 mm, about 1 mm to about 2 mm, about 2 mm to about 4 mm, about 2 mm to about 8 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, or about 20 mm to about 30 mm). As a result of rolling, the left side may be above the right side, or vice versa.
[0241] In an embodiment, the left and right sides do not overlap in the uncompressed (expanded) state, there is a groove from left to right, and the groove has a width of about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 2 mm, about 0.1 mm to about 20 mm, about 0.5 mm to about 1 mm, 0.5 mm to about 2 mm, about 1 mm to about 2 mm, about 2 mm to about 4 mm, about 2 mm to about 8 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, or about 20 mm to about 30 mm).
[0242] In embodiments where the rolling surfaces overlap upon expansion, the overlap forms a ridge. The formation of the ridge upon deployment in bone can be advantageous in that the ridge can capture the inner surface of the hole in the bone such that the device can rotate in one direction but not another. In some embodiments, a deployed device with a rolling surface can rotate to the left but not to the right. In some embodiments, a deployed device with a rolling surface can rotate to the right but not to the left. In some embodiments, the device may not rotate in the direction that the screw is twisted, but may rotate in the direction that the screw is extracted so that both the device and the screw are extracted.
[0243] In embodiments where the rolled surfaces do not overlap upon expansion, the left and right sides of the device form a groove. Forming a groove upon deployment in bone can be advantageous in that the groove (e.g., the left and / or right edges of the device) can trap the inner surface of the hole in the bone so that the device cannot rotate.
[0244] Opening The device has multiple openings, including proximal and distal openings to the internal channel, but also multiple openings on the exterior surface of the device. The proximal, central, and / or distal regions may include at least one opening.
[0245] In some embodiments, the openings extend from one region into at least one other region, e.g., an opening in the central region may extend into the proximal region and / or the distal region. In some embodiments, the openings may extend from the proximal end of the device to the distal end of the device. In some embodiments where at least one opening extends from the proximal end to the distal end, a unitary body of the device (e.g., multiple segments separated by multiple openings, e.g., slits) may be connected by at least one expandable arm.
[0246] In some embodiments, the openings are slits or perforations. In some embodiments, the openings include spiral slits, segmented slits, longitudinal slits, or circumferential slits. In some embodiments, the openings include circular perforations, elliptical perforations, triangular perforations, polygonal perforations, or irregular perforations.
[0247] In some embodiments, the device contains from about 2 to about 5,000 (e.g., from about 2 to about 100, from about 2 to about 200, from about 2 to about 300, from about 2 to about 400, from about 2 to about 500, from about 2 to about 750, from about 2 to about 1,000, from about 2 to about 1,500, from about 2 to about 2,000, from about 2 to about 3,000, from about 2 to about 4,000, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 250, from about 50 ~ about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, about 2500 to about 5000, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41, about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51, about 52, about 53, about 54, about 55, about 56, about 57, about 58, about 59, about 60 , about 61, about 62, about 63, about 64, about 65, about 66, about 67, about 68, about 69, about 70, about 75, about 80, about 85, about 90, about 95, about 100, about 125, about 150, about 175, about 200, about 250, about 300, about 350, about 400, about 450, about 500, about 750, about 1000, about 2000, about 3000, about 4000, or about 5000 openings.
[0248] In some embodiments, the opening has a width of about 0.01 mm to about 2 mm (e.g., about 0.01 mm to about 0.1 mm, about 0.01 mm to about 0.3 mm, about 0.01 mm to about 0.5 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 1 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1.5 mm, or about 1.5 mm to about 2 mm) and a length of about 0.01 mm to about 20 mm (e.g., about 0.01 mm to about 0.1 mm, 0.01 mm to about 0.3 mm, about 0.01 mm to about 0.5 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 1 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1.5 mm, about 1 mm to about 5 mm, about 1.5 mm to about 2 mm, about 2 mm to about 5 mm, about 2 mm to about 8 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, or about 10 mm to about 20 mm).
[0249] In some embodiments, the opening has a length of about 1 mm to about 20 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, 8 mm, 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, 18 mm, about 19 mm, or about 20 mm). In some embodiments, the slit has a width of about 0.1 mm to about 2 mm (e.g., about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or about 2 mm).
[0250] In some embodiments, the opening is about 0.01 mm to about 5 mm (e.g., about 0.01 mm to about 0.1 mm, about 0.01 mm to about 0.3 mm, about 0.01 mm to about 0.5 mm, about 0.1 mm to about 0.5 mm, about 0.1 mm to about 1 mm, about 0.5 mm to about 1 mm, about 1 mm to about 1.5 mm, about 1 mm to about 5 mm, about 1.5 mm to about 2 mm, about 2 mm to about 5 mm, about 0.01 mm, about 0.05 In some embodiments, the diameter of the fluororesin is about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm.
[0251] In some embodiments, the openings include staggered or linear openings.
[0252] In some embodiments, the plurality of perforations are connected by at least one slit. In some embodiments, the slit comprises a spiral slit, a segmented slit, a longitudinal slit, or a circumferential slit. In some embodiments, about 2 to about 100 (e.g., about 2 to about 4, about 2 to about 10, 4 to about 10, 5 to about 10, 6 to about 12, 10 to about 20, about 10 to 50, about 20 to about 60, about 50 to about 100, or about 75 to about 100) perforations are connected by at least one slit.
[0253] In some embodiments, the perforations form a mesh or mesh-like structure. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure comprises a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure comprises a wire gauge of 5 to 50 (e.g., 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0254] The openings are configured for distribution and delivery of biomaterial to the periosseous device. The openings may be configured for uniform distribution and delivery of biomaterial or may be configured to distribute and deliver biomaterial at different levels around the exterior surface of the device. The porosity of the device or in regions of the device determines the distribution and delivery of biomaterial.
[0255] Thread In some embodiments, the device includes one or more threads, such as female and / or male threads. The threads may be present in the proximal region, the central region, and / or the distal region.
[0256] The threads can aid in the placement of an implantable device (e.g., a screw or suture anchor) within the device and / or in the use of the device with other components of a delivery system, for example, a component of a delivery system device may be threaded onto the device.
[0257] In some embodiments, the threads have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm to about 0.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm, or about 1.5 mm to about 2.5 mm, about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm).
[0258] In some embodiments, the threads are formed from protrusions (see, e.g., FIG. 92B), grooves (see, e.g., FIG. 93), corrugations (see, e.g., FIG. 94), or mesh (see, e.g., FIG. 95). In some embodiments, the internal channel is lined with a mesh to form the female threads.
[0259] In some embodiments, the protrusions, grooves, or corrugations are about 1 to about 360 points per 360° (e.g., about 1 to about 4, about 1 to about 6, about 1 to about 8, about 1 to about 10, about 2 to about 4, about 2 to about 6, about 2 to about 10, about 4 to about 10, about 10 to about 20, about 10 to about 50, about 10 to about 100, about 40 to about 60, about 50 to about 100, about 90 to about 180, about 100 to about 200, about 200 to about 300, or about 300 to about 360), where the 360 points per 360° define a complete thread.
[0260] In some embodiments, the thread is a continuous thread or a discontinuous thread. In some embodiments, the thread is broken by at least one opening, such as at least one slit or at least one perforation. In some embodiments, the discontinuous thread includes a gap, and the gap has a length of about 0.5 mm to about 30 mm (e.g., about 0.5 mm to about 1 mm, about 1 mm to about 2 mm, about 2 mm to about 4 mm, about 5 mm to about 10 mm, about 10 mm to about 20 mm, or about 20 mm to about 30 mm).
[0261] In some embodiments, the device includes a threaded equivalent, which is a repeating pattern that allows a second device having a thread or threaded equivalent to be screwed in and secured. Examples of threaded equivalents include repeating protrusions, grooves, meshes, or corrugations.
[0262] protrusion In some embodiments, the device includes at least one protrusion, such as an internal protrusion or an external protrusion, hi some embodiments, the proximal region, the central region, and / or the distal region includes at least one internal protrusion or at least one external protrusion.
[0263] In some embodiments, at least one protrusion (eg, a ridge) extends from the proximal end to the distal end, proximal region, central region, and / or distal region of the device.
[0264] The protrusions may aid in placement of an implantable device (e.g., a screw or suture anchor) within the device and / or use of the device with other components of a delivery system. For example, components of a delivery system device may be snapped onto the device using interlocking or friction fit protrusions.
[0265] In some embodiments, the protrusions are bumps, spikes, tabs, fins, ridges, or raised surfaces.
[0266] In some embodiments, the protrusions include a mesh or mesh-like structure. In some embodiments, the internal channel is lined with a mesh to form an internal protrusion. In some embodiments, the mesh or mesh-like structure includes a diamond, square, circular, woven, or elliptical opening pattern. In some embodiments, the mesh or mesh-like structure is woven, perforated, crimped, welded, molded, sintered, or 3D printed. In some embodiments, the mesh or mesh-like structure includes a porosity of about 5% to about 90% (e.g., about 5% to about 10%, about 5% to about 20%, about 10% to about 25%, about 20% to about 40%, about 20% to about 70%, about 30% to about 60%, about 40% to about 60%, about 50% to about 70%, about 50% to about 90%, or about 70% to about 90%). In some embodiments, the mesh or mesh-like structure comprises a wire gauge of 5 to 50 (eg, 5 to 10, 10 to 20, 10 to 30, 20 to 40, or 30 to 40).
[0267] In some embodiments, the device, proximal region, central region, and / or distal region may have a molecular weight of about 1 to about 5000 (e.g., about 1 to about 100, about 1 to about 200, about 1 to about 300, about 1 to about 400, about 1 to about 500, about 1 to about 750, about 1 to about 1000, about 1 to about 1500, about 1 to about 2000, about 1 to about 3000, about 1 to about 4000, about 10 to about 50, about 10 to about 100, about 50 to about 100, about 50 to about 250, about 50 to about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, about 2500 to about 5000, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 1 8, about 19, about 20, about 21, about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41, about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51, about 52, about 53, about 54, about 55, about 56, about 57, about 58, about 59, about about 60, about 61, about 62, about 63, about 64, about 65, about 66, about 67, about 68, about 69, about 70, about 75, about 80, about 85, about 90, about 95, about 100, about 125, about 150, about 175, about 200, about 250, about 300, about 350, about 400, about 450, about 500, about 750, about 1000, about 2000, about 3000, about 4000, or about 5000 internal protrusions.
[0268] In some embodiments, the device, proximal region, central region, and / or distal region may have a molecular weight of about 1 to about 5000 (e.g., about 1 to about 100, about 1 to about 200, about 1 to about 300, about 1 to about 400, about 1 to about 500, about 1 to about 750, about 1 to about 1000, about 1 to about 1500, about 1 to about 2000, about 1 to about 3000, about 1 to about 4000, about 10 to about 50, about 10 to about 100, about 50 to about 100 , about 50 to about 250, about 50 to about 500, about 100 to about 250, about 250 to about 500, about 500 to about 1000, about 1000 to about 2000, about 2000 to about 3000, about 3000 to about 4000, about 4000 to about 5000, about 2500 to about 5000, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41, about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51, about 52 about 53, about 54, about 55, about 56, about 57, about 58, about 59, about about 60, about 61, about 62, about 63, about 64, about 65, about 66, about 67, about 68, about 69, about 70, about 75, about 80, about 85, about 90, about 95, about 100, about 125, about 150, about 175, about 200, about 250, about 300, about 350, about 400, about 450, about 500, about 750, about 1000, about 2000, about 3000, about 4000, or about 5000 external protrusions.
[0269] Device Edge The device includes a proximal end at the proximal end of the proximal region and a distal end at the distal end of the distal region.
[0270] In some embodiments, the proximal and / or distal ends are blunt, hi some embodiments, the proximal and / or distal ends are tapered.
[0271] In some embodiments, the proximal end and / or the distal end includes at least one milling flute. In some embodiments, the milling flute has a sharp edge. In some embodiments, the proximal end and / or the distal end has between 2 and 5 (e.g., between 2 and 4, 2, 3, 4, or 5) milling flutes.
[0272] In some embodiments, the proximal and / or distal end includes at least one notch, hi some embodiments, the proximal and / or distal end has between two and four (e.g., two, three, or four) notches.
[0273] In some embodiments, the proximal and / or distal end includes at least one bendable tip, hi some embodiments, the proximal and / or distal end has between 1 and 5 (e.g., 1, 2, 3, 4, or 5) bendable tips.
[0274] In some embodiments, the proximal and / or distal end includes at least one elongated slit, hi some embodiments, the proximal and / or distal end has between two and four (e.g., two, three, or four) elongated slits.
[0275] groove In some embodiments, the device includes 1 to 70 (e.g., 1 to 2, 1 to 3, 1 to 4, 2 to 4, 2 to 5, 2 to 6, 4 to 8, 5 to 10, 6 to 12, 5 to 15, 10 to 20, 20 to 40, 30 to 60, or 50 to 70) longitudinal grooves. In some embodiments, the longitudinal grooves are about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about In some embodiments, the longitudinal grooves extend from a proximal end of the central region to a distal end, proximal region, central region, or distal region of the device.
[0276] Alignment Markers In some embodiments, the device may include an alignment marker to facilitate insertion of hardware such as a screw through the device. The alignment marker may be any visible indicator and may include, for example, a radiopaque marker. In some embodiments, the shape of the alignment marker is selected from the group consisting of a square, a diamond, a triangle, a cross, a circle, a horseshoe, and a star. In some embodiments, the alignment marker is a bump or a raised surface.
[0277] Device 100 The device 100 of the present disclosure is an implant that can be used for multiple purposes, including repair of bone defects. The device 100 is configured for insertion into bone (e.g., into a bone hole 875 that is pre-drilled into the bone prior to insertion of the device 100). Once inserted, the device 100 can be used to uniformly deliver biomaterial to the bone, anchor bone structures, and promote bone repair and / or healing.
[0278] The device 100 has a unitary cylindrical body including a proximal region 101, a distal region 151, and a central region 126 disposed therebetween (see, e.g., FIGS. 1, 15, 19A, 21, 33A, 37, 40, 43). The device 100 also includes an internal channel 190 (see, e.g., FIG. 19B) extending longitudinally through the proximal, central, and distal regions.In some embodiments, the device 100 has a diameter of about 9 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm). , about 90mm to about 110mm, about 95mm to about 110mm, about 100mm to about 110mm, about 105mm to about 110mm, about 9mm, about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, about 15mm, about 16mm, about 17mm, about 18mm, Approximately 19mm, approximately 20mm, approximately 21mm, approximately 22mm, approximately 23mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, 58mm, 59mm, 60mm, 61mm, 62mm, 63mm, 64mm, 65mm, 66mm, 67mm, 68mm, 69mm, 70mm, 71mm, 72mm, 73mm, 74mm, 75mm, 7 In some embodiments, the endoscopic catheter has a length of about 6 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm.
[0279] In certain embodiments, the device 100 is constructed from a material selected from the group consisting of stainless steel or its alloys, titanium or its alloys, magnesium or its alloys, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, xenograft biomaterials, and combinations thereof.
[0280] Proximal Region of Device 100 The device 100 includes a proximal region 101 having a proximal end 106, a distal end 107, and a proximal opening 103 to an internal channel 190 disposed in the proximal region 101 (see, e.g., FIGS. 1-3). In some embodiments, the proximal region 101 has an outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). In some embodiments, the proximal region 101 has an inner diameter of about 3 mm to about 20 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In some embodiments, the proximal region 101 has a length of about 2 mm to about 30 mm (e.g., about 2 mm to about 5 mm, about 2 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm). In some embodiments, the proximal region 101 has a wall thickness of about 0.6 mm to about 2.5 mm (e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm). In certain embodiments, the outer diameter of the proximal region 101 is greater than the outer diameter of the central region 126.
[0281] The proximal region 101 includes 3-20 (e.g., 3-15, 4-10, 5-8, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) wings 105 extending radially around an outer surface of the proximal region 101 (see, e.g., FIG. 2). In some embodiments, the wings 105 have a proximal end 106 and a distal end 107 (see, e.g., FIG. 3). In some embodiments, the proximal end 106 of the wings 105 is positioned at the same location as the proximal end 106 of the proximal region 101. In some embodiments, the distal end 107 of the wing 105 is located (along the longitudinal axis of the device 100) from the proximal opening 103 by about 2 mm to about 30 mm (e.g., about 2 mm to about 5 mm, about 2 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, The implant is positioned at a distance of about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm.
[0282] In some embodiments, the wings 105 have a rectangular shape having a length and a width. In some embodiments, all of the wings 105 have substantially equal lengths and widths. In some embodiments, the wings 105 have different lengths and widths. In some embodiments, the length of each wing is about 5 mm to about 20 mm (e.g., about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In some embodiments, the width of each wing is about 1 mm to about 15 mm (e.g., about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, or about 15 mm). In some embodiments, the proximal end 106 of the wing 105 is configured to protrude radially outward from the proximal region 101 at an angle of about 2° to about 10° (e.g., about 2°, about 3°, about 4°, about 5°, about 6°, about 7°, about 8°, about 9°, or about 10°) in the uncompressed (expanded) state (see, e.g., FIG. 70A and FIG. 71). In some embodiments, the proximal ends 106 of the wings 105 are separate from the proximal region 101. In some embodiments, the distal end 107 of each wing is connected to the proximal region 101 and configured to pivot the proximal ends 106 of the wings away from the proximal region 101. In some embodiments, the wings 105 are configured to reversibly flex inwardly toward the internal channel 190 of the proximal region 101, thereby substantially eliminating outward protrusion of the proximal ends 106 of the wings 105 upon compression (see, e.g., FIG. 70B).
[0283] In some embodiments, the proximal region 101 includes a second set of internal threads 121 disposed along the channel wall. In some embodiments, the internal threads 121 of the proximal region 101 have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm). In certain embodiments, the proximal region 101 of the device 100 has an alignment marker 125 (eg, a line, an arrowhead, a colored marking, or a textured marking).
[0284] Central area of device 100 The central region 126 of the device 100 includes an expandable body 130 that includes a plurality of openings 140, a proximal end, and a distal end. The openings 140 may be slits, spiral slits, segmented openings, or perforations that form a mesh or mesh-like structure. The expandable body 130 is configured to expand to allow for uniform distribution and delivery of biomaterial 550 to the bone surrounding the device 100 (see, e.g., FIG. 2). In some embodiments, central region 126 has an outer diameter of about 1.25 mm to about 25 mm (e.g., about 1.5 mm, about 1.75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). Central region 126 includes an outer diameter that is smaller than the outer diameters of the proximal and distal regions. In some embodiments, central region 126 has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In some embodiments, central region 126 has an inner diameter of about 5 mm to about 50 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 50 mm, about 50 mm, about 50 mm, about 50 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 In some embodiments, the catheter has a length of about 6 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, or about 50 mm.In some embodiments, central region 126 has a wall thickness of about 0.15 mm to about 2 mm (e.g., about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or about 2 mm). In certain embodiments, the outer diameter of central region 126 is smaller than the outer diameters of the proximal and distal regions.
[0285] The central region 126 includes an expandable body 130 characterized by having a plurality of openings 140 (e.g., slits, spiral slits, segmented openings, or perforations) (see, e.g., FIG. 4). The expandable body 130 may include a spiral pattern having 2-20 openings 140 (e.g., 2-4, 2-6, 2-8, 2-10, 4-8, 4-10, 4-12, 10-16, 10-20, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20). In some embodiments, the openings 140, e.g., spiral openings, wrap around the periphery of the central region 126 and form a spiral pattern from the proximal end to the distal end of the central region 126 (see, e.g., FIGS. 4, 25B, 27A-B, 28A-B, 29A-B, 30A-B). In some embodiments, the slits have a length of about 1 mm to about 20 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, 18 mm, about 19 mm, or about 20 mm). In some embodiments, the slit has a width of about 0.1 mm to about 2 mm (e.g., about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, or about 2 mm). In some embodiments, the expandable body 130 includes an opening 140 having a circular or elliptical shape.In some embodiments, the circular or oval openings 140 or perforations are between about 1 mm and about 5 mm (e.g., about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3.0 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4.0 mm, about 4.0 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, about 5.0 mm, about 5.0 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, about 5.5 mm, about 5.6 mm, about 5.7 mm, about 5.8 mm, about 5.9 mm, about 6.0 mm, about 6.1 mm, about 6.2 mm, about 6.3 mm, about 6.4 mm, about 6.5 mm, about 6.5 mm, about In some embodiments, the diameter of the endoscopic catheter may be about 3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, or about 5 mm.
[0286] In some embodiments, the central region 126 has 2 to 70 (e.g., 2 to 4, 2 to 5, 2 to 6, 4 to 8, 5 to 10, 6 to 12, 5 to 15, 10 to 20, 20 to 40, 30 to 60, or 50 to 70, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 9, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, or 70) longitudinal grooves 150 (see, e.g., FIG. 4 and FIG. 26A-B).
[0287] In some embodiments, the central region 126 of the device 100 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 130. In some embodiments, the expandable body 130 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 130. In some embodiments, the expandable body 130 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 130. In some embodiments, the expandable body 130 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 130. , about 2.2ml, about 2.3ml, about 2.4ml, about 2.5ml, about 2.6ml, about 2.7ml, about 2.8ml, about 2.9ml, about 3ml, about 3.1ml, about 3.2ml, about 3.3ml, about 3.4ml, about 3.5ml, about 3.6ml, about 3.7ml, about 3.8ml, 3.9ml, 4ml, 4.1ml, 4.2ml, 4.3ml, 4.4ml, 4.5ml, 4.6ml, 4.7ml, 4.8ml, 4.9ml, 5ml, 5.1ml, 5.2ml, 5.3ml, 5.4ml , about 5.5ml, about 5.6ml, about 5.7ml, about 5.8ml, about 5.9ml, about 6ml, about 6.1ml, about 6.2ml, about 6.3ml, about 6.4ml, about 6.5ml, about 6.6ml, about 6.7ml, about 6.8ml, about 6.9ml, about 7ml, about 7. 1ml, about 7.2ml, about 7.3ml, about 7.4ml, about 7.5ml, about 7.6ml, about 7.7ml, about 7.8ml, about 7.9ml, about 8ml, about 8.1ml, about 8.2ml, about 8.3ml, about 8.4ml, about 8.5ml, about 8.6ml, about 8.7ml , about 8.8ml, about 8.9ml, about 9ml, about 9.1ml, about 9.2ml, about 9.3ml, about 9.4ml, about 9.5ml, about 9.6ml, about 9.7ml, about 9.8ml, about 9.9ml, about 10ml, about 11ml, about 11.1ml, about 11.2ml, about 11.3ml, about 11.4ml, about 11.5ml, about 11.6ml, about 11.7ml, about 11.8ml, about 11.9ml, about 12ml, about 12.1ml, about 12.2ml, about 12.3ml, about 12.4ml, about 12.5ml, about 12.6ml, about 12.It can expand to a volume of 7 ml, about 12.8 ml, about 12.9 ml, about 13 ml, about 13.1 ml, about 13.2 ml, about 13.3 ml, about 13.4 ml, about 13.5 ml, about 13.6 ml, about 13.7 ml, about 13.8 ml, about 13.9 ml, about 14 ml, about 14.1 ml, about 14.2 ml, about 14.3 ml, about 14.4 ml, about 14.5 ml, about 14.6 ml, about 14.7 ml, about 14.8 ml, about 14.9 ml, about 15 ml, about 15.1 ml, about 15.2 ml, about 15.3 ml, about 15.4 ml, about 15.5 ml, about 15.6 ml, about 15.7 ml, about 15.8 ml, about 15.9 ml, about 16 ml, about 16.1 ml, about 16.2 ml, about 16.3 ml, about 16.4 ml, about 16.5 ml, about 16.6 ml, about 16.7 ml, about 16.8 ml, about 16.9 ml, about 17 ml, about 17.1 ml, about 17.2 ml, about 17.3 ml, about 17.4 ml, about 17.5 ml, about 17.6 ml, about 17.7 ml, about 17.8 ml, about 17.9 ml, about 18 ml, about 18.1 ml, about 18.2 ml, about 18.3 ml, about 18.4 ml, about 18.5 ml, about 18.6 ml, about 18.7 ml, about 18.8 ml, about 18.9 ml, about 19 ml, about 19.1 ml, about 19.2 ml, about 19.3 ml, about 19.4 ml, about 19.5 ml, about 19.6 ml, about 19.7 ml, about 19.8 ml, about 19.9 ml, or about 20 ml).
[0288] The distal region of device 100 Device 100 includes a distal region 151 including a proximal end, a distal end, and a distal opening 155 to a channel disposed at the distal end (see, e.g., FIGS. 5 and 6). In some embodiments, distal region 151 has an outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). In some embodiments, distal region 151 has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In some embodiments, distal region 151 has a length of about 2 mm to about 30 mm (e.g., about 2 mm to about 5 mm, about 2 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm). In some embodiments, distal region 151 has a wall thickness of about 0.6 mm to about 2.5 mm (e.g., about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm). In certain embodiments, the outer diameter of distal region 151 is greater than the outer diameter of central region 126.
[0289] In some embodiments, the distal region 151 includes a first set of internal threads 160 disposed along the channel wall (see, e.g., Figures 6, 9B, 18B, 19B, 24B, 33B, 42B). In some embodiments, the female threads 160 of the distal region 151 have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm).
[0290] The distal end of distal region 151 may have blunt edges 170 (see, e.g., FIGS. 21, 22, and 24-30). In some embodiments, the distal end of distal region 151 has a set of milling flutes 175 (e.g., having sharp edges) (see, e.g., FIGS. 2 and 5). In some embodiments, the distal end of distal region 151 has between two and five (e.g., two, three, four, or five) milling flutes 175. In some embodiments, the distal region 151 has two to four (e.g., two, three, or four) notches 183 (see, e.g., FIGS. 5, 6, 32, 33A-B, 34A-B, 37, 38, 39, 41, and 42A-B) disposed circumferentially around the distal region 151 or disposed centrally in the distal region 151. In some embodiments, the distal region 151 has one to six (e.g., one, two, three, four, five, or six) openings 188, windows, or holes (see, e.g., FIGS. 21, 22, 23, and 24A-B). In some embodiments, the opening 188 has a diameter of about 2 mm to about 5 mm (e.g., about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, or about 5 mm). In some embodiments, the distal region 151 has multiple (eg, two, three, or four) bendable tips 180 disposed at its distal end (see, eg, FIG. 44).
[0291] In some embodiments, distal region 151 includes a set of external threads 165 (see, e.g., FIG. 14A, FIG. 40, FIG. 41, and FIG. 42A-B). In some embodiments, external threads 165 of distal region 151 have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm).
[0292] Device 1100 74-81 and 91, device 1100 of the present disclosure is an implant that may be used for multiple purposes, including repair of bone defects. Device 1100 is configured for insertion into bone (e.g., into bone hole 875 that is pre-drilled into the bone prior to insertion of device 1100). Once inserted, device 1100 can be used to uniformly deliver biomaterial to bone, anchor bone structures, and promote bone repair and / or healing.
[0293] The device 1100 has a unitary body including, from a proximal end to a distal end, a proximal region 1101, a central region 1126, and a distal region 1151, with the central region 1126 joining the proximal region 1101 to the distal region 1151, a) the device includes an internal channel 1190 extending longitudinally through the proximal region 1101, the central region 1126, and the distal region 1151, b) the proximal region 1101 includes a compressible body and an internal channel 1190. 1 and an opening 1103 to the inner channel 1190; c) the central region 1126 includes i) a plurality of openings 1240; and ii) an expandable and / or compressible body 1130 configured to radially expand or compress, the expandable and / or compressible body including a plurality of longitudinal segments 1191; and d) the distal region 1151 includes an opening 1155 to the inner channel 1190.
[0294] In some embodiments, device 1100 includes one or more threads, such as female and / or male threads. In some embodiments, device 1100 includes at least one protrusion, such as internal protrusion 1131 or external protrusion 1132.
[0295] Proximal Region of Device 1100 The device 1100 includes a proximal region 1101 having a proximal end, a distal end, and a proximal opening 1103 to an internal channel 1190 disposed in the proximal region 1101 (see, eg, FIGS. 74-77).
[0296] In some embodiments, the proximal region 1101 has an outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm to about 8 mm, about 4 mm to about 10 mm, about 4 mm to about 15 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm).
[0297] In some embodiments, the proximal region 1101 has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the outer diameter of the proximal region 1101 is smaller, larger, or equal to the outer diameter of the central region 1126.
[0298] In some embodiments, the proximal region 1101 is about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, In certain embodiments, the inner diameter of the proximal region 1101 is less than, greater than, or equal to the inner diameter of the central region 1126.
[0299] In some embodiments, the proximal region 1101 is about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, In certain embodiments, the wall thickness of the proximal region 1101 is less than, greater than, or equal to the wall thickness of the central region 1126.
[0300] In some embodiments, the proximal region 1101 includes 3 to 20 (e.g., 3 to 15, 4 to 10, 5 to 8, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) wings 1105 extending radially around the outer surface of the proximal region 1101 (see, e.g., FIG. 76).
[0301] Central region of device 1100 The central region 1126 of the device 1100 includes: i) a first section 1134 including a plurality of segments 1191 separated by a plurality of openings 1140; ii) a second section 1133 including a plurality of openings 1140; iii) a proximal end; and iv) a distal end. In some embodiments, the openings 1140 may be slits or perforations. The expandable and / or compressible body 1130 is configured to expand and / or compress to allow for uniform distribution and delivery of biomaterial 550 to the bone surrounding the device 1100 (see, e.g., FIG. 81 ).
[0302] In some embodiments, the central region 1126 is about 1.25 mm to about 25 mm (e.g., about 1.25 mm to about 2 mm, about 1.25 mm to about 3 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 4 mm to about 8 mm, about 4 mm to about 10 mm, about 4 mm to about 15 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about The central region 1126 has an outer diameter of about 20 mm to about 25 mm, about 1.5 mm, about 1.75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. The central region 1126 comprises an outer diameter that is less than, greater than, or equal to the outer diameters of the proximal and distal regions.
[0303] In some embodiments, the central region 1126 has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). The central region 1126 includes an inner diameter that is smaller, larger, or equal to the inner diameters of the proximal and distal regions.
[0304] In some embodiments, the central region 1126 is about 5 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm). m, about 90mm to about 110mm, about 95mm to about 110mm, about 100mm to about 110mm, about 105mm to about 110mm, about 9mm, about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, about 15mm, about 16mm, about 17mm, about 18mm , approximately 19mm, approximately 20mm, approximately 21mm, approximately 22mm, approximately 23mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, Approximately 38mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, Approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm).
[0305] In some embodiments, the central region 1126 is between about 0.15 mm and about 3 mm (e.g., between about 0.15 mm and about 0.5 mm, between about 0.15 mm and about 1 mm, between about 0.15 mm and about 1.5 mm, between about 0.5 mm and about 1 mm, between about 0.5 mm and about 1.5 mm, between about 1 mm and about 2 mm, between about 1 mm and about 3 mm, between about 2 mm and about 3 mm, between about 0.15 mm, between about 0.2 mm, between about 0.3 mm, between about 0.4 mm, between about 0.5 mm, between about 0. In certain embodiments, the central region 1126 has a wall thickness of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm. In certain embodiments, the wall thickness of the central region 1126 is less than, greater than, or equal to the wall thickness of the proximal and distal regions.
[0306] In some embodiments, the central region 1126 has 2 to 20 (e.g., 2 to 4, 2 to 6, 2 to 8, 2 to 10, 4 to 8, 4 to 10, 4 to 12, 10 to 16, 10 to 20, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) segments 1191 (see, e.g., Figures 74-75).
[0307] In some embodiments, the central region 1126 includes a first section 1134 characterized by a plurality of segments 1191 separated by a plurality of openings 1140 (e.g., slits, spiral slits, segmented openings, or perforations). As shown in FIG. 74A, the first section 1134 includes the expandable and / or compressible body 1130 of the device 1100.
[0308] In some embodiments, the central region 1126 includes a second section 1133 characterized by a plurality of openings 1140 (eg, slits, spiral slits, segmented openings, or perforations).
[0309] In some embodiments, the central region 1126 of the device 1100 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the first section 1134 and / or the second section 1133. In some embodiments, the first section 1134 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the first section 1134 and / or the second section 1133. In some embodiments, the first section 1134 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the first section 1134 and / or the second section 1133. In some embodiments, the first section 1134 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the first section 1134 and / or the second section 1133. l, about 2.1ml, about 2.2ml, about 2.3ml, about 2.4ml, about 2.5ml, about 2.6ml, about 2.7ml, about 2.8ml, about 2.9ml, about 3ml, about 3.1ml, about 3.2ml, about 3.3ml, about 3.4ml, about 3.5ml, about 3.6m l, about 3.7ml, about 3.8ml, about 3.9ml, about 4ml, about 4.1ml, about 4.2ml, about 4.3ml, about 4.4ml, about 4.5ml, about 4.6ml, about 4.7ml, about 4.8ml, about 4.9ml, about 5ml, about 5.1ml, about 5.2ml, Approximately 5.3ml, approximately 5.4ml, approximately 5.5ml, approximately 5.6ml, approximately 5.7ml, approximately 5.8ml, approximately 5.9ml, approximately 6ml, approximately 6.1ml, approximately 6.2ml, approximately 6.3ml, approximately 6.4ml, approximately 6.5ml, approximately 6.6ml, approximately 6.7ml, approximately 6.8ml , about 6.9ml, about 7ml, about 7.1ml, about 7.2ml, about 7.3ml, about 7.4ml, about 7.5ml, about 7.6ml, about 7.7ml, about 7.8ml, about 7.9ml, about 8ml, about 8.1ml, about 8.2ml, about 8.3ml, about 8.4ml, about 8.5ml, about 8.6ml, about 8.7ml, about 8.8ml, about 8.9ml, about 9ml, about 9.1ml, about 9.2ml, about 9.3ml, about 9.4ml, about 9.5ml, about 9.6ml, about 9.7ml, about 9.8ml, about 9.9ml, about 10ml, about 1 1ml, about 11.1ml, about 11.2ml, about 11.3ml, about 11.4ml, about 11.5ml, about 11.6ml, about 11.7ml, about 11.8ml, about 11.9ml, about 12ml, about 12.1ml, about 12.2ml, about 12.3ml, about 12.4ml, about 12.5ml, about 12.6ml, about 12.7ml, about 12.8ml, about 12.9ml, about 13ml, about 13.1ml, about 13.2ml, about 13.3ml, about 1 3.4ml, approximately 13.5ml, approximately 13.6ml, approximately 13.7ml, approximately 13.8ml, approximately 13.9ml, approximately 14ml, approximately 14.1ml, approximately 14.2ml, approximately 14.3ml, Approximately 14.4ml, approximately 14.5ml, approximately 14.6ml, approximately 14.7ml, approximately 14.8ml, approximately 14.9ml, approximately 15ml, approximately 15.1ml, approximately 15.2ml, approximately 15.3m l, about 15.4ml, about 15.5ml, about 15.6ml, about 15.7ml, about 15.8ml, about 15.9ml, about 16ml, about 16.1ml, about 16.2ml, about 16. 3ml, about 16.4ml, about 16.5ml, about 16.6ml, about 16.7ml, about 16.8ml, about 16.9ml, about 17ml, about 17.1ml, about 17.2ml, about 1 7.3ml, approximately 17.4ml, approximately 17.5ml, approximately 17.6ml, approximately 17.7ml, approximately 17.8ml, approximately 17.9ml, approximately 18ml, approximately 18.1ml, approximately 18.2ml, The container may be expanded to a volume of about 18.3 ml, about 18.4 ml, about 18.5 ml, about 18.6 ml, about 18.7 ml, about 18.8 ml, about 18.9 ml, about 19 ml, about 19.1 ml, about 19.2 ml, about 19.3 ml, about 19.4 ml, about 19.5 ml, about 19.6 ml, about 19.7 ml, about 19.8 ml, about 19.9 ml, or about 20 ml.
[0310] Distal Region of Device 1100 The device 1100 includes a distal region 1151 that includes a proximal end, a distal end, and a distal opening 1155 to a channel disposed at the distal end (see, eg, FIG. 76).
[0311] In some embodiments, the distal region 1151 is about 4 mm to about 25 mm (e.g., about 4 mm to about 5 mm, about 5 mm to about 15 mm, about 10 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm In certain embodiments, the outer diameter of the distal region 1151 is less than, greater than, or equal to the outer diameter of the central region 1126.
[0312] In some embodiments, distal region 1151 has an inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 2 mm to about 5 mm, about 4 mm to about 8 mm, about 5 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the distal region 1151 is smaller than, larger than, or equal to the inner diameter of the central region 1126 .
[0313] In some embodiments, the distal region 1151 is about 1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 ... , about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm in length.
[0314] In some embodiments, the distal region 1151 is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0. In certain embodiments, the wall thickness of the distal region 1151 is less than, greater than, or equal to the wall thickness of the central region 1126.
[0315] The distal end of the distal region 1151 may have a blunt edge. The distal end of the distal region 1151 may have a tapered edge 1171.
[0316] Device 1200 82-85, device 1200 of the present disclosure is an implant that can be used for multiple purposes, including repair of bone defects. Device 1200 is configured for insertion into bone (e.g., into a bone hole 875 that has been pre-drilled into the bone prior to insertion of device 1200). Once inserted, device 1200 can be used to uniformly deliver biomaterial to the bone, anchor bone structures, and promote bone repair and / or healing.
[0317] The device 1200 includes a one-piece body including a proximal end and a distal end, a) the one-piece body includes an expandable and / or compressible body configured to radially expand or compress, b) the one-piece body is configured to radially expand or compress, the one-piece body includes a rolled surface having an internal channel 1290 extending longitudinally from the proximal end to the distal end, b) the one-piece body includes a plurality of openings 1240, c) the internal channel 1290 includes an internal protrusion 1231 and / or an internal thread, d) the proximal end includes an opening 1203 into the internal channel 1290, and e) the distal end includes an opening 1255 into the internal channel 1290.
[0318] In some embodiments, device 1200 includes one or more threads, such as female and / or male threads. In some embodiments, device 1200 includes at least one protrusion, such as internal protrusion 1231 or an external protrusion.
[0319] Proximal Region of Device 1200 In some embodiments, the device 1200 includes a proximal region 1201 having a proximal end, a distal end, and a proximal opening 1203 to an internal channel 1290 disposed in the proximal region 1201 (see, for example, Figures 82-83).
[0320] In some embodiments, proximal region 1201 has an uncompressed (expanded) or compressed (unexpanded) outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm to about 8 mm, about 4 mm to about 10 mm, about 4 mm to about 15 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). In certain embodiments, the outer diameter of the proximal region 1201 is less than, greater than, or equal to the outer diameter of the central region 1226 .
[0321] In some embodiments, proximal region 1201 has an uncompressed (expanded) or compressed (unexpanded) inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the proximal region 1201 is smaller than, larger than, or equal to the inner diameter of the central region 1226 .
[0322] In some embodiments, the proximal region 1201 is about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm in length.
[0323] In some embodiments, the proximal region 1201 is about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, In certain embodiments, the wall thickness of the proximal region 1201 is less than, greater than, or equal to the wall thickness of the central region 1226.
[0324] In some embodiments, the proximal region 1201 does not have any openings other than the opening 1203. In some embodiments, the device 1200 does not have a proximal region 1201.
[0325] Device 1200 central region The central region 1226 of the device 1200 includes an expandable body 1230 that contains a number of openings 1240, a proximal end, and a distal end. In some embodiments, the openings 1240 may be slits or perforations. The expandable body 1230 is configured to expand to allow for uniform distribution and delivery of biomaterial 550 to the bone surrounding the device 1200.
[0326] In some embodiments, the central region 1226 is about 1.25 mm to about 25 mm (e.g., about 1.25 mm to about 2 mm, about 1.25 mm to about 3 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm~5mm, 4mm~8mm, 4mm~10mm, 4mm~15mm, 5mm~10mm, 10mm~15mm, 10mm~20mm, 15mm~25mm, 20mm~25 The central region 1226 has an uncompressed (expanded) or compressed (unexpanded) outer diameter of about 1.25 mm to about 3 mm, about 1.5 mm, about 1.75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. The central region 1226 comprises an outer diameter that is less than, greater than, or equal to the outer diameters of the proximal and distal regions.
[0327] In some embodiments, central region 1226 has an uncompressed (expanded) or compressed (unexpanded) inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). The central region 1226 includes an inner diameter that is smaller than, larger than, or equal to the inner diameters of the proximal and distal regions.
[0328] In some embodiments, the central region 1226 is about 5 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm). m, about 90mm to about 110mm, about 95mm to about 110mm, about 100mm to about 110mm, about 105mm to about 110mm, about 9mm, about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, about 15mm, about 16mm, about 17mm, about 18mm , approximately 19mm, approximately 20mm, approximately 21mm, approximately 22mm, approximately 23mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, Approximately 38mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, Approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm).
[0329] In some embodiments, the central region 1226 is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0. In certain embodiments, the central region 1226 has a wall thickness of about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm. In certain embodiments, the wall thickness of the central region 1226 is less than, greater than, or equal to the wall thickness of the proximal and distal regions.
[0330] In some embodiments, the central region 1226 of the device 1200 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 1230. In some embodiments, the expandable body 1230 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 1230. In some embodiments, the expandable body 1230 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 1230. In some embodiments, the expandable body 1230 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable body 1230. l, about 2.2ml, about 2.3ml, about 2.4ml, about 2.5ml, about 2.6ml, about 2.7ml, about 2.8ml, about 2.9ml, about 3ml, about 3.1ml, about 3.2ml, about 3.3ml, about 3.4ml, about 3.5ml, about 3.6ml, about 3.7ml, Approximately 3.8ml, approximately 3.9ml, approximately 4ml, approximately 4.1ml, approximately 4.2ml, approximately 4.3ml, approximately 4.4ml, approximately 4.5ml, approximately 4.6ml, approximately 4.7ml, approximately 4.8ml, approximately 4.9ml, approximately 5ml, approximately 5.1ml, approximately 5.2ml, approximately 5.3ml, approximately 5.4m l, about 5.5ml, about 5.6ml, about 5.7ml, about 5.8ml, about 5.9ml, about 6ml, about 6.1ml, about 6.2ml, about 6.3ml, about 6.4ml, about 6.5ml, about 6.6ml, about 6.7ml, about 6.8ml, about 6.9ml, about 7ml, about 7 .1ml, about 7.2ml, about 7.3ml, about 7.4ml, about 7.5ml, about 7.6ml, about 7.7ml, about 7.8ml, about 7.9ml, about 8ml, about 8.1ml, about 8.2ml, about 8.3ml, about 8.4ml, about 8.5ml, about 8.6ml, about 8.7m l, about 8.8ml, about 8.9ml, about 9ml, about 9.1ml, about 9.2ml, about 9.3ml, about 9.4ml, about 9.5ml, about 9.6ml, about 9.7ml, about 9.8ml, about 9.9ml, about 10ml, about 11ml, about 11.1ml, about 11.2ml, about 11.3ml, about 11.4ml, about 11.5ml, about 11.6ml, about 11.7ml, about 11.8ml, about 11.9ml, about 12ml, about 12.1ml, about 12.2ml, about 12.3ml, about 12.4ml, about 12.5ml, about 12.6ml, about 12.7ml, approx. 12.8ml, approx. 12.9ml, approx. 13ml, approx. 13.1ml, approx. 13.2ml, approx. 13.3ml, approx. 13.4ml, approx. 13.5ml, approx. 13.6ml , about 13.7ml, about 13.8ml, about 13.9ml, about 14ml, about 14.1ml, about 14.2ml, about 14.3ml, about 14.4ml, about 14.5ml, about 1 4.6ml, approximately 14.7ml, approximately 14.8ml, approximately 14.9ml, approximately 15ml, approximately 15.1ml, approximately 15.2ml, approximately 15.3ml, approximately 15.4ml, approximately 15.5 ml, approx. 15.6ml, approx. 15.7ml, approx. 15.8ml, approx. 15.9ml, approx. 16ml, approx. 16.1ml, approx. 16.2ml, approx. 16.3ml, approx. 16.4ml, Approximately 16.5ml, approximately 16.6ml, approximately 16.7ml, approximately 16.8ml, approximately 16.9ml, approximately 17ml, approximately 17.1ml, approximately 17.2ml, approximately 17.3ml, approximately 17 .4ml, approx. 17.5ml, approx. 17.6ml, approx. 17.7ml, approx. 17.8ml, approx. 17.9ml, approx. 18ml, approx. 18.1ml, approx. 18.2ml, approx. 18.3m 1, about 18.4 ml, about 18.5 ml, about 18.6 ml, about 18.7 ml, about 18.8 ml, about 18.9 ml, about 19 ml, about 19.1 ml, about 19.2 ml, about 19.3 ml, about 19.4 ml, about 19.5 ml, about 19.6 ml, about 19.7 ml, about 19.8 ml, about 19.9 ml, or about 20 ml.
[0331] Distal Region of Device 1200 In some embodiments, the device 1200 includes a distal region 1251 including a proximal end, a distal end, and a distal opening 1255 to a channel disposed at the distal end (see, e.g., FIG. 82).
[0332] In some embodiments, the distal region 1251 is about 4 mm to about 25 mm (e.g., about 4 mm to about 5 mm, about 5 mm to about 15 mm, about 10 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm In certain embodiments, the distal region 1251 has an uncompressed (expanded) or compressed (unexpanded) outer diameter of about 23 mm, about 24 mm, or about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. In certain embodiments, the outer diameter of the distal region 1251 is less than, greater than, or equal to the outer diameter of the central region 1226.
[0333] In some embodiments, distal region 1251 has an uncompressed (expanded) or compressed (unexpanded) inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 2 mm to about 5 mm, about 4 mm to about 8 mm, about 5 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the distal region 1251 is smaller than, larger than, or equal to the inner diameter of the central region 1226 .
[0334] In some embodiments, distal region 1251 is about 1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 15 ... , about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm in length.
[0335] In some embodiments, distal region 1251 is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, m, about 0.7 mm, about 0.8 mm, mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm). In certain embodiments, the wall thickness of the distal region 1251 is less than, greater than, or equal to the wall thickness of the central region 1226.
[0336] In some embodiments, the distal end of the distal region 1251 may have a blunt edge. The distal end of the distal region 1251 may have a tapered edge.
[0337] In some embodiments, distal region 1251 does not have any openings other than opening 1255. In some embodiments, device 1200 does not have distal region 1251.
[0338] Device 1300 86-90, device 1300 of the present disclosure is an implant that can be used for multiple purposes, including repair of bone defects. Device 1300 is configured for insertion into bone (e.g., into a bone hole 875 that has been pre-drilled into the bone prior to insertion of device 1300). Once inserted, device 1300 can be used to uniformly deliver biomaterial to the bone, anchor bone structures, and promote bone repair and / or healing.
[0339] The device 1300 has a unitary body including, from a proximal end to a distal end, a proximal region 1301, a central region 1326, and a distal region 1351, the central region 1326 joining the proximal region 1301 to the distal region 1351, a) the device includes an internal channel 1390 ( FIG. 89 ) extending longitudinally through the proximal region 1301, the central region 1326, and the distal region 1351, b) the proximal region 1301 includes a compressible body and an internal channel 1390; c) central region 1326 includes i) a plurality of openings 1340; ii) an expandable and / or compressible body configured to radially expand or compress, the expandable and / or compressible body including a plurality of longitudinal segments 1391 connected by a plurality of expandable arms 1392; and d) distal region 1351 includes an opening 1355 to internal channel 1390.
[0340] In some embodiments, device 1300 includes one or more threads, such as female and / or male threads. In some embodiments, device 1300 includes at least one protrusion, such as internal protrusion 1331 or external protrusion 1332.
[0341] Proximal Region of Device 1300 The device 1300 includes a proximal region 1301 having a proximal end, a distal end, and a proximal opening 1303 to an internal channel 1390 disposed in the proximal region 1301 (see, eg, FIGS. 86-88).
[0342] In some embodiments, proximal region 1301 has an uncompressed (expanded) or compressed (unexpanded) outer diameter of about 4 mm to about 25 mm (e.g., about 4 mm to about 8 mm, about 4 mm to about 10 mm, about 4 mm to about 15 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 25 mm, about 20 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm). In certain embodiments, the outer diameter of the proximal region 1301 is less than, greater than, or equal to the outer diameter of the central region 1326 .
[0343] In some embodiments, the proximal region 1301 is about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 12 mm, about 16 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 13 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the proximal region 1301 is less than, greater than, or equal to the inner diameter of the central region 1326.
[0344] In some embodiments, the proximal region 1301 is about 0.1 mm to about 30 mm (e.g., about 0.1 mm to about 1 mm, about 0.1 mm to about 5 mm, about 0.1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 5 mm to about 20 mm, about 10 mm to about 20 mm, about 10 mm to about 30 mm, about 15 mm to about 25 mm, about 20 mm to about 30 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm in length.
[0345] In some embodiments, the proximal region 1301 is about 0.15 mm to about 2.5 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, In certain embodiments, the wall thickness of the proximal region 1301 is less than, greater than, or equal to the wall thickness of the central region 1326.
[0346] In some embodiments, the proximal region 1301 includes 3 to 20 (e.g., 3 to 15, 4 to 10, 5 to 8, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) wings 1305 extending radially around the outer surface of the proximal region 1301.
[0347] Device 1300 central region The central region 1326 of the device 1300 includes i) an expandable and / or compressible body 1330 including multiple segments 1391 separated by multiple expandable arms 1392 and openings 1340, ii) a proximal end, and iii) a distal end. The openings 1340 may be slits or perforations. The expandable and / or compressible body 1330 is configured to expand and / or compress to allow for uniform distribution and delivery of biomaterial 550 to the bone surrounding the device 1300.
[0348] In some embodiments, the central region 1326 is about 1.25 mm to about 25 mm (e.g., about 1.25 mm to about 2 mm, about 1.25 mm to about 3 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm). , about 1mm to about 5mm, about 4mm to about 8mm, about 4mm to about 10mm, about 4mm to about 15mm, about 5mm to about 10mm, about 10mm to about 15mm, about 10mm to about 20mm, about 15mm to about 25mm, about 20 The central region 1326 has an uncompressed (expanded) or compressed (unexpanded) outer diameter of about 25 mm, about 1.5 mm, about 1.75 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. The central region 1326 comprises an outer diameter that is less than, greater than, or equal to the outer diameters of the proximal and distal regions.
[0349] In some embodiments, central region 1326 has an uncompressed (expanded) or compressed (unexpanded) inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 1 mm to about 10 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about 10 mm to about 15 mm, about 15 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). The central region 1326 includes an inner diameter that is smaller than, larger than, or equal to the inner diameters of the proximal and distal regions.
[0350] In some embodiments, the central region 1326 is about 5 mm to about 110 mm (e.g., about 10 mm to about 110 mm, about 20 mm to about 110 mm, about 25 mm to about 110 mm, about 30 mm to about 110 mm, about 35 mm to about 110 mm, about 40 mm to about 110 mm, about 45 mm to about 110 mm, about 50 mm to about 110 mm, about 55 mm to about 110 mm, about 60 mm to about 110 mm, about 65 mm to about 110 mm, about 70 mm to about 110 mm, about 75 mm to about 110 mm, about 80 mm to about 110 mm, about 85 mm to about 110 mm). , about 90mm to about 110mm, about 95mm to about 110mm, about 100mm to about 110mm, about 105mm to about 110mm, about 9mm, about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, about 15mm, about 16mm, about 17mm, about 18mm, Approximately 19mm, approximately 20mm, approximately 21mm, approximately 22mm, approximately 23mm, approximately 24mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, 58mm, 59mm, 60mm, 61mm, 62mm, 63mm, 64mm, 65mm, 66mm, 67mm, 68mm, 69mm, 70mm, 71mm, 72mm, 73mm, 74mm, 75mm, 7 In some embodiments, the endoscopic catheter has a length of about 6 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, about 100 mm, about 101 mm, about 102 mm, about 103 mm, about 104 mm, about 105 mm, about 106 mm, about 107 mm, about 108 mm, about 109 mm, or about 110 mm.
[0351] In some embodiments, the central region 1326 is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0. In certain embodiments, the wall thickness of the central region 1326 is less than, greater than, or equal to the wall thickness of the proximal and distal regions.
[0352] The central region 1326 includes an expandable and / or compressible body 1330 characterized by a number of segments 1391 separated by a number of expandable arms 1392 and a number of openings 1340 (eg, slits or perforations).
[0353] In some embodiments, the central region 1326 has 2 to 20 (e.g., 2 to 4, 2 to 6, 2 to 8, 2 to 10, 4 to 8, 4 to 10, 4 to 12, 10 to 16, 10 to 20, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20) segments 1391 (see, e.g., Figures 86-88).
[0354] In some embodiments, the central region 1326 includes 2 to 100 (e.g., 2 to 10, 2 to 20, 10 to 20, 10 to 30, 10 to 50, 20 to 40, 20 to 60, 40 to 80, 50 to 100, 60 to 80, 80 to 100, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 10 2, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100) of extendable arms 1392 (see, e.g., Figures 86-88).
[0355] In some embodiments, the central region 1326 includes 2 to 70 (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, or 70) external protrusions 1332 (see, e.g., Figures 88-89).
[0356] In some embodiments, the central region 1326 of the device 1300 is configured to expand, thereby providing a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable and / or compressible body 1330. In some embodiments, the expandable and / or compressible body 1330 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable and / or compressible body 1330. In some embodiments, the expandable and / or compressible body 1330 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable and / or compressible body 1330. In some embodiments, the expandable and / or compressible body 1330 is configured to provide a volume for receiving biomaterial 550, which can be delivered to the bone through the expandable and / or compressible body 1330. ml, about 2ml, about 2.1ml, about 2.2ml, about 2.3ml, about 2.4ml, about 2.5ml, about 2.6ml, about 2.7ml, about 2.8ml, about 2.9ml, about 3ml, about 3.1ml, about 3.2ml, about 3.3ml, about 3.4ml, about 3.5ml , about 3.6ml, about 3.7ml, about 3.8ml, about 3.9ml, about 4ml, about 4.1ml, about 4.2ml, about 4.3ml, about 4.4ml, about 4.5ml, about 4.6ml, about 4.7ml, about 4.8ml, about 4.9ml, about 5ml, about 5.1ml, about 5 .2ml, about 5.3ml, about 5.4ml, about 5.5ml, about 5.6ml, about 5.7ml, about 5.8ml, about 5.9ml, about 6ml, about 6.1ml, about 6.2ml, about 6.3ml, about 6.4ml, about 6.5ml, about 6.6ml, about 6.7ml, about 6 .8ml, about 6.9ml, about 7ml, about 7.1ml, about 7.2ml, about 7.3ml, about 7.4ml, about 7.5ml, about 7.6ml, about 7.7ml, about 7.8ml, about 7.9ml, about 8ml, about 8.1ml, about 8.2ml, about 8.3ml, about 8.4m l, about 8.5ml, about 8.6ml, about 8.7ml, about 8.8ml, about 8.9ml, about 9ml, about 9.1ml, about 9.2ml, about 9.3ml, about 9.4ml, about 9.5ml, about 9.6ml, about 9.7ml, about 9.8ml, about 9.9ml, about 10ml, Approximately 11ml, approximately 11.1ml, approximately 11.2ml, approximately 11.3ml, approximately 11.4ml, approximately 11.5ml, approximately 11.6ml, approximately 11.7ml, approximately 11.8ml, approximately 11.9ml, approximately 12ml, approximately 12.1ml, approximately 12.2ml, approximately 12.3ml, approximately 12.4ml, about 12.5ml, about 12.6ml, about 12.7ml, about 12.8ml, about 12.9ml, about 13ml, about 13.1ml, about 13.2ml, about 13.3ml, about 1 3.4ml, approximately 13.5ml, approximately 13.6ml, approximately 13.7ml, approximately 13.8ml, approximately 13.9ml, approximately 14ml, approximately 14.1ml, approximately 14.2ml, approximately 14.3ml, Approximately 14.4ml, approximately 14.5ml, approximately 14.6ml, approximately 14.7ml, approximately 14.8ml, approximately 14.9ml, approximately 15ml, approximately 15.1ml, approximately 15.2ml, approximately 15.3m l, about 15.4ml, about 15.5ml, about 15.6ml, about 15.7ml, about 15.8ml, about 15.9ml, about 16ml, about 16.1ml, about 16.2ml, about 16. 3ml, about 16.4ml, about 16.5ml, about 16.6ml, about 16.7ml, about 16.8ml, about 16.9ml, about 17ml, about 17.1ml, about 17.2ml, about 1 7.3ml, approximately 17.4ml, approximately 17.5ml, approximately 17.6ml, approximately 17.7ml, approximately 17.8ml, approximately 17.9ml, approximately 18ml, approximately 18.1ml, approximately 18.2ml, The container may be expanded to a volume of about 18.3 ml, about 18.4 ml, about 18.5 ml, about 18.6 ml, about 18.7 ml, about 18.8 ml, about 18.9 ml, about 19 ml, about 19.1 ml, about 19.2 ml, about 19.3 ml, about 19.4 ml, about 19.5 ml, about 19.6 ml, about 19.7 ml, about 19.8 ml, about 19.9 ml, or about 20 ml.
[0357] Distal Region of Device 1300 The device 1300 includes a distal region 1351 that includes a proximal end, a distal end, and a distal opening 1355 to a channel disposed at the distal end (see, eg, FIG. 86).
[0358] In some embodiments, the distal region 1351 is about 4 mm to about 25 mm (e.g., about 4 mm to about 5 mm, about 5 mm to about 15 mm, about 10 mm to about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm In certain embodiments, the distal region 1351 has an uncompressed (expanded) or compressed (unexpanded) outer diameter of about 23 mm, about 24 mm, or about 25 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm. In certain embodiments, the outer diameter of the distal region 1351 is less than, greater than, or equal to the outer diameter of the central region 1326.
[0359] In some embodiments, distal region 1351 has an uncompressed (expanded) or compressed (unexpanded) inner diameter of about 1 mm to about 20 mm (e.g., about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 1 mm to about 5 mm, about 2 mm to about 5 mm, about 4 mm to about 8 mm, about 5 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 15 mm, about 10 mm to about 20 mm, about 15 mm to about 20 mm, about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, or about 20 mm). In certain embodiments, the inner diameter of the distal region 1351 is smaller than, larger than, or equal to the inner diameter of the central region 1326 .
[0360] In some embodiments, the distal region 1351 has a length of about 1 mm to about 30 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, or about 30 mm).
[0361] In some embodiments, distal region 1351 is about 0.15 mm to about 3 mm (e.g., about 0.15 mm to about 0.5 mm, about 0.15 mm to about 1 mm, about 0.15 mm to about 1.5 mm, about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 3 mm, about 0.15 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, m, about 0.7 mm, about 0.8 mm, mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm. In certain embodiments, the wall thickness of the distal region 1351 is less than, greater than, or equal to the wall thickness of the central region 1326.
[0362] In some embodiments, the distal end of the distal region 1351 may have a blunt edge. The distal end of the distal region 1351 may have a tapered edge.
[0363] Systems for bone repair Also featured is a system 1000 that includes a device as described herein and one or more of an insertion tool 200, a pusher 300, and a connector 400 (see, eg, FIGS. 18A and 59).
[0364] Insert Tool The insertion tool 200 has a proximal region 210, a distal region 240, and a central region 220 that connects the proximal region 210 to the distal region 240 (see, e.g., FIG. 7). The proximal region 210 includes a handle 215 (see, e.g., FIGS. 7, 55, 57, 58). In some embodiments, the handle 215 is shaped (e.g., rectangular, circular, oval, polygonal, or T-shaped) to be grasped by a user's hand.In some embodiments, the handle 215 is about 10 mm to about 100 mm (e.g., about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 73 mm, about 74 mm, about 75 mm, about 76 mm, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about mm, approx. 41mm, approx. 42mm, approx. 43mm, approx. 44mm, approx. 45mm, approx. 46mm, approx. 47mm, approx. 48mm, approx. 49mm, approx. 50mm, approx. , 59mm, 60mm, 61mm, 62mm, 63mm, 64mm, 65mm, 66mm, 67mm, 68mm, 69mm, 70mm, 71mm, 72mm, 73mm, 74mm, 75mm, 76mm, approx. 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, or about 100 mm in length, about 5 mm to about 25 mm (for example, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm , about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm) and a height of about 5 mm to about 25 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm).In some embodiments, the handle 215 has a cylindrical shape and a diameter of about 5 mm to about 25 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, or about 25 mm).
[0365] The central region 220 of the insertion tool 200 connects the proximal region 210 to the distal region 240 of the insertion tool 200. Typically, the central region 220 of the insertion tool 200 is a non-threaded cylindrical shaft having a diameter that terminates in a lip 230 (see, e.g., FIG. 7, 9A-9B, 51A, 52, 55). In some embodiments, the central region 220 is about 5 mm to about 100 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 30 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 ... m, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37mm, approximately 38 mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50mm, approximately 5 1mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63mm, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76mm, The tool insertion 200 has a length of about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, or about 100 mm. In some embodiments, the tool insertion 200 has an interior channel 280 that extends from the proximal end 201 of the proximal region 210 to the distal end 202 of the distal region 240 of the tool insertion 200 (see, e.g., FIGS. 8A-8B and 52). In some embodiments, the central region 220 of the tool insertion 200 has an outer diameter and an inner diameter. In some embodiments, the outer diameter of central region 220 is between about 5 mm and about 10 mm (eg, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, or about 10 mm).In some embodiments, the inner diameter of central region 220 is about 0.5 mm to about 3 mm (e.g., about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm). In some embodiments, central region 220 has a set of threads with a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm).
[0366] Generally, the distal region 240 of the insertion tool 200 is a cylindrical shaft having a reduced diameter relative to the diameter of the central region 220 (see, e.g., FIGS. 7, 52, 55). In some embodiments, the distal region 240 of the insertion tool 200 is between about 5 mm and about 100 mm (e.g., about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm, about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about 41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm, about 47 mm, about 48 mm, about 49 mm, about 50 mm, about 50 mm, about 51 mm, about 52 mm, about 53 mm, about 54 mm, about 55 mm, about 56 mm, about 57 mm, about 58 mm, about 59 mm, about 60 mm, about 61 mm, about 62 mm, about 63 mm, about 64 mm, about 65 mm, about 66 mm, about 67 mm, about 68 mm, about 69 mm, about 70 mm, about 71 mm, about 72 mm, about 75 mm, mm, approximately 25mm, approximately 26mm, approximately 27mm, approximately 28mm, approximately 29mm, approximately 30mm, approximately 31mm, approximately 32mm, approximately 33mm, approximately 34mm, approximately 35mm, approximately 36mm, approximately 37 mm, approximately 38mm, approximately 39mm, approximately 40mm, approximately 41mm, approximately 42mm, approximately 43mm, approximately 44mm, approximately 45mm, approximately 46mm, approximately 47mm, approximately 48mm, approximately 49mm, approximately 50m m, approximately 51mm, approximately 52mm, approximately 53mm, approximately 54mm, approximately 55mm, approximately 56mm, approximately 57mm, approximately 58mm, approximately 59mm, approximately 60mm, approximately 61mm, approximately 62mm, approximately 63m m, approximately 64mm, approximately 65mm, approximately 66mm, approximately 67mm, approximately 68mm, approximately 69mm, approximately 70mm, approximately 71mm, approximately 72mm, approximately 73mm, approximately 74mm, approximately 75mm, approximately 76m m, about 77 mm, about 78 mm, about 79 mm, about 80 mm, about 81 mm, about 82 mm, about 83 mm, about 84 mm, about 85 mm, about 86 mm, about 87 mm, about 88 mm, about 89 mm, about 90 mm, about 91 mm, about 92 mm, about 93 mm, about 94 mm, about 95 mm, about 96 mm, about 97 mm, about 98 mm, about 99 mm, or about 100 mm). In some embodiments, the distal region 240 has an outer diameter and an inner diameter. In some embodiments, the outer diameter of the distal region 240 is about 2 mm to about 5 mm (e.g., about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.1 mm, about 3.2 mm, about 3.3 mm, about 3.4 mm, about 3.5 mm, about 3.6 mm, about 3.7 mm, about 3.8 mm, about 3.9 mm, about 4 mm, about 4.1 mm, about 4.2 mm, about 4.3 mm, about 4.4 mm, about 4.5 mm, about 4.6 mm, about 4.7 mm, about 4.8 mm, about 4.9 mm, or about 5 mm).In some embodiments, the inner diameter of the distal region 240 is about 0.5 mm to about 3 mm (e.g., about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, or about 3 mm). The distal region 240 of the insertion tool 200 may also include at least one set of male threads 250 (see, e.g., FIGS. 7, 9B, 18B, 52, 55, 57-59). In some embodiments, the male threads 250 are configured to engage with the female threads 160 and 121 in the proximal and distal regions of the device 100 (see, e.g., Figures 9B, 18B, 19B, 24B, 33B, 42B). In some embodiments, the first set of distal region threads may have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm). In some embodiments, the second set of distal region threads may have a thread pitch of about 0.25 mm to about 2.5 mm (e.g., about 0.25 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm). In some embodiments, the male threads 250 are separated from the male threads 260 by a non-threaded region 270 of the distal region 240 of the insertion tool 200 (see, e.g., FIG. 55).In some embodiments, the non-threaded region 270 is between about 10 mm and about 100 mm (e.g., about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24 mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about 30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35...
Claims
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, the central region joining the proximal region to the distal region; a) the device comprises an internal channel extending longitudinally through the proximal region, the central region, and the distal region; b) the proximal region includes an opening to the internal channel and a plurality of circumferentially disposed, compressible wings; c) the central region comprises a compressible body configured to be radially compressed during insertion and to return to an uncompressed state when radial pressure is removed; and d) the distal region comprises an opening to the internal channel and an internal thread.
2. 10. The device of claim 1, a) the proximal region comprises an inner diameter of about 1 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm; b) the central region comprises an inner diameter of 1 mm to about 20 mm and an outer diameter of about 1.25 mm to about 25 mm; c) the distal region comprises an inner diameter of 1 mm to about 20 mm and an outer diameter of about 4 mm to about 25 mm; or d) 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. 10. The device of claim 1, wherein the outer diameter of the proximal region and / or the distal region is: a) greater than the outer diameter of the central region; or b) smaller than the outer diameter of the central region.
4. 10. The device of claim 1, A) comprising a length of about 9 mm to about 110 mm; B) comprising 1 to 70 longitudinal grooves; and / or C) The device comprises a plurality of longitudinal segments.
5. The device of claim 1 , wherein the central region comprises internal or external threads.
6. 6. The device of claim 5, wherein the internal or external threads are broken by slits.
7. The device of claim 6 , wherein the slit is a spiral slit, a segmented slit, a longitudinal slit, or a circumferential slit.
8. 5. The device of claim 4, wherein in B), the longitudinal grooves are: a) comprising a depth of about 0.15 mm to about 2.5 mm; and / or b) the device extending from the proximal end of the central region to the distal end of the central region.
9. 5. The device according to claim 4, wherein in C) a) the proximal region, the central region, and / or the distal region comprise a plurality of segments; b) the plurality of segments extend from the proximal end through the central region to the distal end; c) the plurality of segments have a polygonal, circular, triangular, elliptical, cylindrical, or irregular shape; d) the device comprises 2 to 10 segments; e) each of the segments is the same size; f) each of the segments is separated by at least one opening, the opening having a maximum width of about 0.1 mm to about 50 mm; g) each of the segments comprises a length of from about 9 mm to about 110 mm; or h) The device wherein each of said segments comprises a width of from about 0.1 mm to about 50 mm.
10. 10. The device of claim 9, i) In a), the plurality of segments comprises longitudinal segments; or ii) The device of c), wherein the plurality of segments comprises a rectangular shape.
11. 10. The device of claim 1, wherein the proximal region comprises: A) comprising a length of about 2 mm to about 30 mm; B) a wall thickness of about 0.15 mm to about 3.0 mm; C) with internal or external protrusions; and / or D) The device is provided with an internal or external thread.
12. The device of claim 11, wherein in B), the wall thickness of the proximal region is about 0.3 mm to about 0.6 mm.
13. 12. The device according to claim 11, wherein in C) a) the internal or external protrusions comprise one or more of bumps, spikes, tabs, fins, ridges, or raised surfaces; b) the internal or external protrusion extends from the proximal end to the distal end of the proximal region; c) a plurality of internal or external protrusions extending from the proximal end to the distal end of the proximal region; and / or d) The device, wherein the device comprises 1 to 500 internal or external protrusions.
14. 12. The device according to claim 11, wherein in D), the internal or external thread is: a) having a thread pitch of about 0.25 mm to about 2.5 mm; b) formed from protrusions, grooves, corrugations, or meshes; c) comprising a continuous or discontinuous thread; and / or d) The device is broken by a slit.
15. 15. The device of claim 14, i) In b), the protrusions, grooves, or corrugations are about 1 to about 180 points per 360°; ii) in c), the discontinuous threads include gaps, the gaps having a length of about 0.5 mm to about 30 mm; and / or iii) The device of d), wherein the slit is a spiral slit, a segmented slit, a longitudinal slit, or a circumferential slit.
16. 10. The device of claim 1, wherein the central region comprises: A) comprising a length of about 5 mm to about 110 mm; B) comprising a wall thickness of about 0.15 mm to about 2 mm; C) with internal or external protrusions; and / or D) a first section comprising the compressible body, wherein the central region further comprises a second section comprising a plurality of openings.
17. 17. The device of claim 16, wherein in B), the wall thickness of the central region is about 0.8 mm to about 0.9 mm.
18. 17. The device of claim 16, wherein in C) a) the internal or external protrusions of the central region comprise bumps, spikes, tabs, fins, ridges, or raised surfaces; b) the internal or external projection extends from the proximal end to the distal end of the central region; c) a plurality of internal or external protrusions extending from the proximal end to the distal end of said central region; and / or d) The device, wherein the device comprises 1 to 500 internal or external protrusions.
19. The female or male thread is a) having a thread pitch of about 0.25 mm to about 2.5 mm; b) formed from protrusions, grooves, corrugations, or meshes; and / or 17. The device of claim 16, comprising c) a continuous or discontinuous thread.
20. 20. The device of claim 19, i) In b), the protrusions, grooves, or corrugations are about 1 to about 180 points per 360°; and / or ii) The device of c), wherein the discontinuous threads include gaps, the gaps having a length of about 0.5 mm to about 30 mm.
21. 17. The device of claim 16, wherein in 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 about 5 mm to about 100 mm; and / or c) the device, wherein the second section comprises a length of about 5 mm to about 100 mm.
22. 10. The device of claim 1, wherein the distal region comprises: A) comprising a length of about 2 mm to about 30 mm; B) a wall thickness of about 0.15 mm to about 2.5 mm; C) comprising a distal end; D) 2 to 4 notches and / or elongated slits; E) having 1 to 5000 openings; F) having internal or external protrusions; G) provided with an external thread; and / or H) The device comprises a plurality of bendable tips disposed at the proximal end and / or the distal end.
23. 23. The device of claim 22, a) In B), the wall thickness of the distal region is about 0.4 mm to about 0.5 mm; b) In D), the slits include spiral slits, segmented slits, longitudinal slits, or circumferential slits; and / or c) The device of E), wherein the diameter of each opening is from about 0.01 mm to about 5 mm.
24. 23. The device of claim 22, wherein in C), the distal end of the distal region comprises: a) have blunt and / or tapered edges; and / or b) The device comprises 2 to 5 milling flutes, optionally the distal region comprises 3 milling flutes.
25. 23. The device of claim 22, wherein in F) a) the internal or external protrusions comprise one or more of bumps, spikes, tabs, fins, ridges, or raised surfaces; b) the internal or external protrusion extends from the proximal end to the distal end of the distal region; c) a plurality of internal or external protrusions extend from the proximal end to the distal end of the distal region; and / or d) The device, wherein the device comprises 1 to 500 internal or external protrusions.
26. 23. The device of claim 22, wherein in G) the external thread comprises: a) having a thread pitch of about 0.25 mm to about 2.5 mm; b) formed from protrusions, grooves, corrugations, or meshes; c) comprising a continuous or discontinuous thread; and / or d) The device is broken by a slit.
27. 27. The device of claim 26, i) In b), the protrusions, grooves, or corrugations are about 1 to about 180 points per 360°; ii) in c), the discontinuous threads include gaps, the gaps having a length of about 0.5 mm to about 30 mm; and / or iii) The device of d), wherein the slit is a spiral slit, a segmented slit, a longitudinal slit, or a circumferential slit.
28. 10. The device of claim 1, wherein each of the wings comprises: A) having a rectangular, circular, elliptical, triangular, sawtooth, or parabolic shape, including length and width; B) a proximal end separated from the proximal region and configured to project outwardly from the proximal region; and C) the device comprising a distal end connected to the proximal region and configured to pivot the proximal ends of the wings away from the proximal region.
29. 29. The device of claim 28, a) each of said wings comprises a length of about 5 mm to about 20 mm and / or a width of 1 mm to 15 mm; and / or b) The device, wherein the device comprises 3 to 20 wings.
30. 30. The device of claim 29, wherein in b) there are four to eight wings.
31. 31. The device of claim 30, comprising eight wings.
32. 29. The device of claim 28, wherein in B), the proximal end of each of the wings comprises: a) protruding outward from the proximal region at an angle of about 2° to 10°; and b) said device being configured to reversibly flex toward said proximal region upon compression to substantially eliminate said outward protrusion of said proximal end.
33. The device of claim 1 , wherein the compressible body comprises a plurality of openings.
34. 34. The device of claim 33, wherein the plurality of openings comprise slits or perforations.
35. 35. The device of claim 34, wherein the plurality of openings comprise spiral slits, segmented slits, longitudinal slits, circumferential slits, circular perforations, elliptical perforations, triangular perforations, polygonal perforations, or irregular perforations.
36. 36. The device of claim 35, A) the opening extends into the proximal region and / or the distal region; B) the device comprises 2 to 500 openings; C) the opening comprises a width of about 0.01 mm to about 20 mm and a length of about 0.01 mm to about 20 mm; D) the opening comprises a perforation, the perforation comprising a circular, oval, triangular, polygonal, or irregular shape comprising a diameter of about 0.1 mm to about 5 mm; E) the opening comprises perforations, a plurality of the perforations being connected by at least one slit; or F) The device as described above, wherein the openings comprise perforations, the perforations forming a mesh or mesh-like structure.
37. 37. The device of claim 36, wherein in E) a) the slit is a spiral slit, a segmented slit, a longitudinal slit, or a circumferential slit; or b) The device, wherein the slits connect 2 to 100 perforations.
38. 37. The device of claim 36, wherein in F) the mesh or mesh-like structure comprises: a) woven, punched, crimped, welded, molded, sintered or 3D printed; b) comprises a porosity of about 5% to about 90%; or c) The device comprises a wire gauge of 5 to 50.
39. The device of claim 1 , wherein the internal threads of the distal region have a thread pitch of about 0.25 mm to about 2.5 mm.
40. 10. The device of claim 1, wherein the device is made from or comprises a material selected from the group consisting of stainless steel or its alloys, titanium or its alloys, magnesium or its alloys, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, xenograft biomaterials, and combinations thereof.
41. 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.
42. A) the proximal region comprises: a) a length of about 5 mm to about 10 mm, and b) a wall thickness of about 0.3 mm to about 0.5 mm; c) an inner diameter of about 1 mm to about 20 mm; and d) an outer diameter of about 4 mm to about 25 mm; B) the central region is a) a length of about 14 mm to about 26 mm; b) a wall thickness of about 0.8 mm to about 0.9 mm; c) an inner diameter of 1 mm to about 20 mm; and d) an outer diameter of about 1.25 mm to about 25 mm; and C) the distal region comprises: a) a length of about 15 mm to about 30 mm; b) a wall thickness of about 0.4 mm to about 0.5 mm; c) an inner diameter of 1 mm to about 20 mm; and d) an outer diameter of about 4 mm to about 25 mm.
43. A) the proximal region comprises: e) a first plurality of openings, each of the openings comprising: i) a width of about 1.5 mm to about 2 mm, and ii) the first plurality of openings comprising a length of about 2 mm to about 5 mm; f) a second plurality of openings, each of the openings comprising: i) a width of about 1 mm to about 1.5 mm, and ii) the second plurality of openings comprising a length of about 1 mm to about 1.5 mm; B) the central region is e) a plurality of slits, each comprising a width of about 1.4 mm; f) an internal thread having a pitch of about 1.2 mm to about 1.3 mm; and C) the distal region comprises: e) a third plurality of openings, each of the openings comprising: i) a width of about 1.5 mm to about 2 mm, and ii) the third plurality of openings comprising a length of about 2 mm to about 5 mm; D) each of the plurality of circumferentially disposed compressible wings comprises a width of about 1 mm to about 2 mm; E) the outer diameter of the proximal region is about 4 mm to about 5 mm, and the inner diameter of the proximal region is about 3 mm to about 4 mm; F) the outer diameter of the central region is about 5 mm to about 6 mm and the inner diameter of the central region is about 3 mm to about 4 mm; and G) The device of claim 42, wherein the outer diameter of the distal region is about 4 mm to about 5 mm and the inner diameter of the distal region is about 3 mm to about 4 mm.
44. i) the length of the proximal region is about 7 mm; ii) the length of the central region is about 18 mm to about 19 mm; and iii) the length of the distal region is between about 19 mm and about 20 mm.
45. i) the length of the proximal region is about 8 mm to about 9 mm; ii) the length of the central region is from about 21 mm to about 22 mm; and 44. The device of claim 43, wherein iii) the length of the distal region is about 25 mm to about 26 mm.
46. A system comprising a device according to any one of claims 1 to 45, wherein the device is connected to a connector or pre-loaded into a cylinder.
47. A device according to any one of claims 1 to 45 for use in bone repair.
48. A kit for treating bone defects comprising a device according to any one of claims 1 to 45, a) an insertion tool; b) extraction tools; c) funnel; d) a connector; e) a screw or suture anchor; f) a washer; g) a container containing the biomaterial; h) a biomaterial dispenser; and i) a bone plate.
49. 49. The kit of claim 48, i) the connector d), comprising a frusto-conical shape having a proximal region, a distal region, and an internal channel extending from the proximal region to the distal region; a) the proximal region comprises a Luer Lock thread; and b) the distal region of the connector includes a plurality of circumferentially disposed, radially extending wedges. ii) said screw e) comprising a length sufficient to traverse the length of said device; a) screw head, b) a diameter of about 1 mm to about 20 mm; c) a length of about 5 mm to about 300 mm; d) threads having a thread pitch of about 0.25 mm to about 2.5 mm; e) a non-threaded body, or f) the screw comprises a material selected from the group consisting of stainless steel or its alloys, titanium or its alloys, magnesium or its alloys, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chromium, and combinations thereof; iii) said washer f), a) a proximal region, a distal region, and an internal channel extending longitudinally through the proximal and distal regions of the washer, the washer being sized to fit within the internal channel of the proximal region of the device; b) the proximal region of the washer comprises an outer diameter of about 5 mm to about 30 mm; c) the proximal region of the washer comprises an inner diameter of about 2 mm to about 20 mm; d) the distal region of the washer comprises an outer diameter of about 2.8 mm to about 19.8 mm. e) the distal region of the washer comprises an inner diameter of about 2 to about 20 mm; and / or f) a washer wherein the outer diameter of the proximal region of the washer is greater than the outer diameter of the distal region of the washer; iv) a biomaterial, a) a polymer adhesive; b) bone void filling material; c) cement; d) phosphoserine-based bioadhesives; e) flocculants; f) bone forming agents; g) pharmaceutical agents; h) Pharmaceuticals, and i) the following biomaterial compositions: calcium phosphate-based bone cement, non-self-setting calcium phosphate-based bone void filler, flowable xenograft bone void filler, polymethacrylate (PMMA), polymethyl methacrylate (PMMA), calcium sulfate, metal alloys, polysaccharides, nucleic acids, carbohydrates, proteins, polypeptides, poly(α-hydroxy acids), poly(lactones), poly(amino acids), poly(anhydrides), poly(orthoesters), poly(anhydride-co-imides), poly(orthocarbonates), poly(α-hydroxyalkanoates), poly(dioxanone), poly(phosphoesters), poly(L-lactide) (PLLA), poly(D,L-lactide) (PDLLA), polyglycolide (PGA), poly(lactide-co-glycolide) (PLGA), poly(L-lactide-co-D,L-lactide), poly( ...L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(ε-caprolactone), poly(δ-valerolactone), poly(γ-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fiber, poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-poly(propylene oxide), block copolymer, poly(ethylene terephthalate) polyamide, potassium acrolein, (meth)acrylamide, (meth)acrylic acid and salts thereof, (meth)acrylate, acrylonitrile, ethylene, ethylene glycol, ethyleneimine, ethylene oxide, styrene sulfonate, vinyl acetate, vinyl alcohol, vinyl chloride, vinylpyrrolidone a homopolymer or copolymer comprising one or more monomers selected from the group consisting of gallotannins, ellagitannins, taragallotannins, caffetannins, proanthocyanidins, catechins, epicatechins, chlorogenic acid, and arbutin; a polyphenol complexing agent selected from alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,O-carboxymethylchitosan, dextran, and fibrin. the biomaterial comprising one or more of: lau, glycerol, hyaluronic acid, sodium hyaluronate, cellulose, glucosamine, proteoglycan, starch, lactic acid, pluronic, sodium glycerophosphate, collagen, glycogen, keratin, silk, transforming growth factor-beta (TGF-β), activin, inhibin, bone morphogenetic protein (BMP), antibiotic, enzyme inhibitor, antihistamine, anti-inflammatory agent, muscle relaxant, antispasmodic, analgesic, prostaglandin, antidepressant, trophic factor, or hormone, v) the biomaterial dispenser h), a) a tube connected to a syringe; b) a vial or reservoir, optionally the tube further containing the biomaterial; and / or vi) the bone plate i), a) the bone plate comprising two or more bone plate holes; The kit further comprises: