Devices, systems, and methods for bone repair or reinforcement
Patent Information
- Application Number
- PCT/IB2025/052889
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-21
- Filing Date
- 2025-03-19
- Publication Date
- 2025-12-26
AI Technical Summary
Existing devices fail to effectively control the interface between injectable fluidic biomaterials and biostable implants, leading to implant failure and bone fracture collapse, particularly in cases of bone loss, compaction, or fragility due to injury or disease.
A unitary body device with proximal, central, and distal regions, featuring internal channels and openings such as helical slits or holes, designed to uniformly distribute biomaterials around implants, enhancing fixation and repair.
The device ensures uniform distribution and delivery of biomaterials, improving implant fixation and bone repair by stabilizing bone and preventing fracture collapse.
Smart Images

Figure IB2025052889_26122025_PF_FP_ABST
Abstract
Description
[0001] DEVICES, SYSTEMS, AND METHODS FOR BONE REPAIR OR REINFORCEMENT
[0002] Background of the Invention
[0003] Fixation and repair of damaged bone is frequently compromised due to bone fractures that result in bone loss, compaction, or fragility from injury or disease. Metal, ceramics, and other biostable materials have been used for over a century to treat bone / soft tissue injuries and diseases. Although new biomaterials, with bone substituting and regeneration capabilities, have been developed for use in combination with biostable implants to expedite bone fracture and soft tissue repair, the interface between injectable fluidic biomaterials and the biostable implants cannot be adequately controlled with most devices on the market. Oftentimes implant failure results along with fracture collapse and nonunion with prolonged and disruptive disability for the patient.
[0004] Thus, there exists a need for devices and methods for effective biomaterial injection, placement, and fixation which improve the distribution of biomaterial around the implants.
[0005] Summary of the Disclosure
[0006] The devices, systems, and methods of the disclosure provide implants and uses thereof for repairing bone defects (e.g., bone fractures), stabilizing bone, or providing or improving implant fixation. The implants disclosed herein can be used to achieve uniform distribution and delivery of a biomaterial to the bone to be repaired or to a site of implant fixation.
[0007] In a first aspect, the 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, in which one or two of these regions may be absent. In some embodiments, the device includes a proximal region, central region, and distal region. In some embodiments, the device includes a proximal region and a distal region while the central region is absent. In some embodiments, the device includes a central region while the proximal region and distal region are absent. The device includes an internal channel extending longitudinally through the unitary body. The proximal region, central region, and distal region each comprise a plurality of openings or an external thread. The proximal region, central region, and distal region are stiff (i.e., inflexible, incompressible, and / or non-expandible, e.g., having a Young's modulus of greater than about 100 GPa). The device can be configured as a compression screw component, a fastener, and / or a suture anchor.
[0008] In some embodiments the proximal, central, and distal regions are of substantially equal stiffness (e.g., within ±10% difference or less).
[0009] In some embodiments, the plurality of openings are configured to disperse a biomaterial injected or placed into the internal channel to an area surrounding the unitary body. In some embodiments, the plurality of openings are configured to induce toroidal flow of a biomaterial injected through the internal channel, where such plurality of openings are helical slits.
[0010] In some embodiments, the plurality of openings comprises helical openings. In some embodiments, the helical openings are continuous openings spanning the proximal region or central region from a proximal end to a distal end of the region. In some embodiments, the helical openings have a pitch of between about 10 mm and 100 mm (e.g., about 50 mm, e.g., 51 .5 mm). In some embodiments, the helical openings have a number of turns per unit length of between 0.1 and 5 turns / cm (e.g., about 0.4 turns / cm, e.g., 0.375 turns / cm). In some embodiments, the plurality of openings includes 2-10 helical openings; preferably 4-6 helical openings. In some embodiments, the helical openings are helical slits.
[0011] In some embodiments, the plurality of openings are slits. In some embodiments, the slits are segmented slits, longitudinal slits, or circumferential slits.
[0012] In some embodiments, the plurality of openings are holes. In some embodiments, the holes are dispersed along a length of the central region or the distal region from a proximal end to a distal end of the region. In some embodiments, the plurality of openings has an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. In some embodiments, the plurality of openings are diamond-shaped openings.
[0013] In some embodiments, the plurality of openings includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings or 4 helical slits).
[0014] In some embodiments, the plurality of openings include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about
[0015] 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 .5 mm to about 2 mm, from about
[0016] 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about
[0017] 3 to about 4.5 mm, or from about 4 to about 5 mm e.g., about 2 mm, e.g., about 1 .8 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about
[0018] 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about
[0019] 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
[0020] In some embodiments, a total surface area of the plurality of openings includes are from about
[0021] 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of the proximal region, central region, and / or distal region.
[0022] In some embodiments, the plurality of openings includes a first plurality of openings and a second plurality of openings, where the first plurality of openings has a different shape than the second plurality of openings. In some embodiments, the first plurality of openings are helical openings and the second plurality of openings are non-helical openings.
[0023] In some embodiments, the first plurality of openings are helical slits. In some embodiments, the first plurality of openings are continuous openings spanning or substantially spanning the central region from a proximal end to a distal end. In some embodiments, the helical openings have a pitch of between about 10 mm and 100 mm (e.g., about 50 mm, e.g., 51 .5 mm). In some embodiments, the helical openings have a number of turns per unit length of between 0.1 and 5 turns / cm (e.g., about 0.4 turns / cm, e.g., 0.375 turns / cm). In some embodiments, the first plurality of openings includes 2-10 helical openings; preferably 4-6 helical openings. In some embodiments, the first plurality of openings together encompass from between about 20% to 80% (e.g., from about 30% to about 70%, from about 40% to about 60%, or from about 45% to about 55%, e.g., about 40%, about 45%, about 50%, or about 55%) of a total external surface area of the proximal region or the central region.
[0024] In some embodiments, the first plurality of openings includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100 openings, e.g., about 4 helical openings).
[0025] In some embodiments, the first plurality of openings include a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2.4 mm, about 2.3 mm, about 2 mm, or about 1 .8 mm,,) and a length of from about 0.1 mm to about 150 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm). In some embodiments, the first plurality of openings include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
[0026] In some embodiments, the second plurality of openings are slits. In some embodiments, the second plurality of openings are holes. In other embodiments, the openings (whether as slits or holes) are positioned (e.g., uniformly, randomly, with a dispersion gradient, etc.) along a length of the distal region. In some embodiments, the second plurality of openings have an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. In some embodiments, the second plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes or polygonal holes. In some embodiments, the second plurality of openings together encompass from about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of the proximal region, central region, and / or distal region
[0027] In some embodiments, the second plurality of openings includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings).
[0028] In some embodiments, the second plurality of openings includes a cross-sectional dimension (e.g., a diameter or a width) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.3 mm, about 2.5 mm, about 3 mm, about 4 mm, or about 5 mm).
[0029] In some embodiments, the unitary body includes an external thread configured to engage with a locking screw (e.g., a lag screw). In some embodiments, the proximal region includes the external thread. In some embodiments, the unitary body (e.g., the proximal, distal, and / or central regions) includes a textured surface, e.g., having a roughness average (Ra) of between about 1 micron to about 5 microns (e.g., about 3-4 microns, e.g., about 3.5 microns, e.g., about 3.6 microns). In some embodiments, the textured surface has a roughness that improves interaction with a biomaterial (e.g., adhesion properties).
[0030] In some embodiments, the internal channel includes an internal thread through at least one of the proximal region, central region, or distal region.
[0031] In some embodiments, the device is 3D printed and / or is made from a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
[0032] In a second aspect, the disclosure features a system for reinforcing a bone of a subject. The system includes a device of the first aspect, the device may be, for example, a fastener, and one or more implant components which engage with the device. In some embodiments, the system further includes an intramedullary nail (e.g., a cephalomedullary nail), in which the device engages with (or, e.g., fastens to) the intramedullary nail to reinforce the bone of the subject.
[0033] In some embodiments, the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus. In some embodiments, the intramedullary nail includes a first hole having a diameter, wherein the fastener is configured to insert in the hole, and wherein the hole is disposed at a proximal end of the intramedullary nail. In some embodiments, the intramedullary nail has a second hole at the distal end and the system further includes a screw configured to be inserted in the second hole.
[0034] In some embodiments, the system for reinforcing a bone of a subject includes a device of the first aspect, the device being, for example, a compression screw component and one or more implants which engage with the device. In some embodiments, the system further includes a locking screw (e.g., a lag screw), an intramedullary nail (e.g., a cephalomedullary nail), in which the locking screw and the device (e.g., as a compression screw component) engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
[0035] In some embodiments, the unitary body of the device (e.g., a compression screw component) includes an external thread configured to engage with a locking screw (e.g., a lag screw). In some embodiments, the proximal region of the unitary body includes the external thread configured to engage with the locking screw. In some embodiments, the locking screw is a lag screw. In some embodiments, the compression screw component and lag screw have a complementary pitch, e.g., of between 0.25 and 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about
[0036] 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 11 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about
[0037] 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11 .5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm).
[0038] In some embodiments, the locking screw has a diameter that is greater than a diameter of the device (e.g., a compression screw component) and / or the nail has a curved trapezoidal cross-section. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus. In some embodiments, the intramedullary nail includes a first hole having a diameter and a thread and a second hole distal to and adjacent to the first hole; in which the locking screw is configured to engage with the first hole and the device (e.g., a compression screw component) is configured to engage with the second hole; and where the first hole and second hole are disposed at the proximal end of the intramedullary nail.
[0039] In some embodiments, the first and second holes are spaced and angled such that the device (e.g., a compression screw component) and locking screw fixedly engage when both are fully inserted. In some embodiments, the intramedullary nail has a third hole at distal end and the system further includes a third screw configured to be inserted in the third hole.
[0040] In some embodiments, the one or more implants includes a bone plate with one or more bone plate holes sized to engage with the device. In some embodiments the bone plate includes two or more bone plate holes. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus. In some embodiments, the system includes a plurality of the devices of the first aspect. In some embodiments, the plurality of devices includes from 2-12 devices (e.g., from 2-10 devices, from 2-8 devices, from 2-6 devices, from 2-4 devices, from 4-12 devices, from 4- 10 devices, from 4-6 devices, from 6-12 devices, from 6-10 devices, from 6-8 devices, from 8-12 devices, from 8-10 devices, or from 10-12 devices).
[0041] In a third aspect, the disclosure features a system for reinforcing a soft tissue of a subject. The system includes a device of the first aspect, in which the device may be, for example, a suture anchor. In some embodiments, the device includes a suture, in which the suture and the device (e.g., as a suture anchor) secure the soft tissue to a bone by way of the suture. In some embodiments, the system further includes a plurality of devices (e.g., a plurality of suture anchors, e.g., from 2-6 suture anchors).
[0042] In a fourth aspect, the disclosure features a kit for reinforcing a bone or soft tissue of a subject (e.g., a human subject). The kit includes a device according to the first aspect and a biomaterial and / or hydrating fluid. In some embodiments, the kit further includes a dispenser that is configured to inject a biomaterial and / or a hydrating fluid through the internal channel of the device. In some embodiments, the dispenser includes a tube connected to a syringe, a vial, or a reservoir; wherein optionally, the tube further includes the biomaterial or the hydrating fluid.
[0043] In some embodiments, the kit includes an intramedullary nail (e.g., a cephalomedullary nail) and, for example, the device is, or is configured as, a fastener. The fastener is configured to engage with the intramedullary nail to reinforce the bone.
[0044] In some embodiments, the bone is a long bone and the fastener and intramedullary nail are sized to fit the bone. In some embodiments, the intramedullary nail includes a hole having a diameter, and wherein the fastener is configured for insertion in the hole.
[0045] In some embodiments, the kit includes a locking screw and an intramedullary nail (e.g., a cephalomedullary nail) and, for example, the device is, or is configured as, a compression screw component. The locking screw and compression screw component are configured to engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
[0046] In some embodiments, the bone is a long bone and the compression screw component, intramedullary nail, and the locking screw are sized to fit the bone. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus. In some embodiments, the intramedullary nail includes a first hole having a diameter and a thread and a second hole distal to and adjacent to the first hole, and wherein the locking screw is configured to engage with the first hole and the compression screw component is configured to engage with the second hole. In some embodiments, the first and second holes are spaced and angled such that the compression screw component and locking screw integrate when both are fully inserted.
[0047] In some embodiments, the one or more implants of the kit includes a bone plate with one or more bone plate holes sized to engage with the device.
[0048] In some embodiments, the bone plate includes two or more bone plate holes. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
[0049] In some embodiments, the kit includes the device which is configured as a suture anchor. The suture anchor is configured to secure a soft tissue to a bone of a subject. In some embodiments, the suture anchor includes a suture. In some embodiments, the kit includes a plurality of devices (e.g., a plurality of suture anchors, e.g., from 2-6 suture anchors).
[0050] In some embodiments, the biomaterial includes a polymeric adhesive, a bone void filler material, a cement, a phosphoserine-based bioadhesive, a cohesiveness agent, an osteogenic agent, an osteoconductive agent, a medicinal agent, a solid biomaterial (e.g., a solid dose biomaterial), a pharmaceutical agent, or a combination thereof.
[0051] In some embodiments, the biomaterial includes a calcium phosphate-based bone cement, a non- self-hardening calcium phosphate based bone void filler, a flowable xenograft bone void filler, phosphoserine, phosphocreatine, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a calcium silicate, a calcium phosphate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(a-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(a-hydroxy alkanoate), a poly(dioxanone), a poly(phosphoester), poly(L-lactide) (PLLA), poly(D,L-lactide) (PDLLA), polyglycolide (PGA), poly(lactide-co-glycolide (PLGA), poly(L-lactide-co-D, L-lactide), poly(D,L-lactide-co- trimethylene carbonate), polyhydroxybutyrate (PHB), poly(E-caprolactone), poly(b-valerolactone), poly(y- butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fibers, poly(ethylene glycol), polyethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), polyethylene oxide)-co-poly(propylene oxide), a block copolymer, polyethylene terephthalate)polyamide, a homo-polymer or a co-polymer including one or more monomers selected from the group consisting of acrolein potassium, (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 polyphenolic complexing agent selected from a gallotannin, an ellagitannin, a taragallotannin, a caffetannin, a proanthocyanidin, catechin, epicatechin, chlorogenic acid, and arbutin, alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N.O-carboxymethyl chitosan, a dextran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, a cellulose, a glucosamine, a proteoglycan, a starch, lactic acid, a poloxamer, sodium glycerophosphate, collagen, glycogen, a keratin, silk, transforming growth factors-beta (TGF-p), an activin, an inhibin, a bone morphogenetic proteins (BMP), an antibiotic, an enzyme inhibitor, an antihistamine, an anti-inflammatory agent, a muscle relaxant, an anti-spasmodic, an analgesic, a prostaglandin, an anti-depressant, a trophic factor, a hormone, or combinations thereof.
[0052] In some embodiments, the biomaterial is disposed within the biomaterial dispenser. In some embodiments, the biomaterial dispenser includes a tube connected to a syringe, a vial, or a reservoir; in which, optionally, the tube further includes the biomaterial.
[0053] In other embodiments, the biomaterial is pre-loaded into the internal channel of a device according to the first aspect (e.g., as a solid biomaterial, such as a solid dose biomaterial (e.g., in the form of pellets)). In some embodiments, the plurality of openings are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of pellets of a solid biomaterial (e.g., a solid dose biomaterial) that has been pre-loaded into an internal channel of the device. In some embodiments, the pre-loaded solid dose biomaterial (e.g., in the form of pellets) includes a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof. In some embodiments, the pre-loaded solid dose biomaterial (e.g., in the form of pellets) includes from about 65 to about 85% (e.g., about 65-80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71%, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81%, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight. In some embodiments, the pre-loaded solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., 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%, or about 35%) phosphoserine or phosphocreatine by weight. In some embodiments, the pre-loaded solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1 .8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2-1 .0%, about 0.2-0.8%, about 0.2-0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1 .0-2.0%, about 1 .0-1 .5%, about 1 .5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.1 %, about 1 .2%, about 1 .3%, about 1.4%, about 1 .5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight. In some embodiments, the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10- 100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, or about 150 MPa). In some embodiments, the pre-loaded solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1 .20 to about 1 .80 g / cm3(e.g., about 1 .20-1 .75 g / cm3, about 1 .20-1 .70 g / cm3, about 1 .20-1 .60 g / cm3, about 1 .20-1 .50 g / cm3, about 1 .20-1 .40 g / cm3, about 1 .20-1 .30 g / cm3, about 1 .20-1 .25 g / cm3, about 1 .30-1 .80 g / cm3, about 1 .30-1 .50 g / cm3, about 1 .5-1 .8 g / cm3, e.g., about 1 .20 g / cm3, about 1 .25 g / cm3, about 1 .30 g / cm3, about 1 .35 g / cm3, about 1 .40 g / cm3, about 1 .45 g / cm3, about 1 .5 g / cm3, about 1 .55 g / cm3, about 1 .60 g / cm3, about 1 .65 g / cm3, about 1 .70 g / cm3, about 1 .75 g / cm3, or about 1 .80 g / cm3).
[0054] In a fifth aspect, the disclosure features a method of treating a bone defect in a bone or soft tissue defect in a soft tissue of a subject (e.g., a human). The method includes implanting a device of the first aspect into a bone of the subject and dispersing a biomaterial from the internal channel of the device out of the first plurality of openings and the second plurality of openings into a portion of bone tissue surrounding the device, thereby treating the bone defect. In an embodiment, the biomaterial is, e.g., a solid biomaterial, such as a solid dose biomaterial (e.g., in the form of pellets). In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes from about 65 to about 85% (e.g., about 65-80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71 %, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81 %, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25- 30%, about 22-27%, e.g., 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%, or about 35%) phosphoserine or phosphocreatine by weight. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1 .8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2- 1 .0%, about 0.2-0.8%, about 0.2-0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1 .0-2.0%, about 1 .0-1 .5%, about 1 .5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1 .0%, about 1.1 %, about 1 .2%, about 1 .3%, about 1 .4%, about 1 .5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight. In some embodiments, the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10- 20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 110 MPa, about 120 MPa, about 130 MPa, about 140 MPa, or about 150 MPa). In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1 .20 to about 1 .80 g / cm3(e.g., about 1 .20-1 .75 g / cm3, about 1 .20-1 .70 g / cm3, about 1 .20-1 .60 g / cm3, about 1 .20-1 .50 g / cm3, about 1 .20-1 .40 g / cm3, about 1 .20-1 .30 g / cm3, about 1 .20-1 .25 g / cm3, about 1 .30-1 .80 g / cm3, about 1 .30-1 .50 g / cm3, about 1 .5-1 .8 g / cm3, e.g., about 1 .20 g / cm3, about 1 .25 g / cm3, about 1 .30 g / cm3, about 1 .35 g / cm3, about 1 .40 g / cm3, about 1 .45 g / cm3, about 1 .5 g / cm3, about 1 .55 g / cm3, about 1 .60 g / cm3, about 1 .65 g / cm3, about 1 .70 g / cm3, about 1 .75 g / cm3, or about 1 .80 g / cm3). The biomaterial can convert to a fluid form (e.g., a paste) following exposure to a hydrating fluid (e.g., blood) that hydrates the biomaterial in the body of a subject after implantation, thereby allowing the biomaterial to disperse from the device and harden. In a separate embodiment, the method includes fluidly connecting a source of a biomaterial to the internal channel of the device and injecting the biomaterial into the internal channel so that the biomaterial flows out from the plurality of openings into a portion of bone tissue surrounding the device, thereby treating the bone defect and / or securing the device to the bone.
[0055] In some embodiments, a greater quantity of the biomaterial is delivered to a portion of bone tissue adjacent to the proximal region or the central region than to a portion of bone tissue adjacent to the distal region. In some embodiments, the biomaterial flows out from the plurality of openings in a uniformly radially expanding volume. In some embodiments, the biomaterial flows out from the plurality of openings with toroidal flow. In some embodiments, the plurality of openings that induce toroidal flow of a biomaterial injected through the internal channel are helical slits. In some embodiments, method includes inserting a screw through the internal channel of the device, e.g., to distribute the biomaterial.
[0056] In some embodiments, the method further includes securing a bone plate to the bone by inserting the device through the bone plate hole during implantation. In some embodiments, the method further includes fastening the distal end of the device to the distal cortex of the bone. In some embodiments, the bone plate includes two or more bone plate holes and / or the method includes securing the bone plate to the bone using more than one device of the first aspect (e.g., to form a compression assembly). In some embodiments, the bone defect is outside of a fracture zone. In some embodiments, the implanting includes screwing the device into the bone. In some embodiments, the implanting does not include screwing the device into the bone. In some embodiments, the implanting includes inserting the device through a hole drilled into the bone.
[0057] In some embodiments, the inserting includes providing torque perpendicularly to a long axis of the device and / or pushing in a proximal to distal direction along the long axis of the device.
[0058] In some embodiments, the method further includes implanting an intramedullary nail (e.g., a cephalomedullary nail) into a medullary cavity of the bone. In such embodiments, the device may be configured as a fastener that engages with the intramedullary nail to reinforce the bone.
[0059] In some embodiments, the bone is a long bone. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
[0060] In some embodiments, the intramedullary nail includes a hole, wherein during implantation the fastener is inserted through the hole. In some embodiments, the method further includes implanting a screw into the bone through a second hole in the intramedullary nail that is distal to the fastener.
[0061] In some embodiments, the method further includes implanting an intramedullary nail (e.g., a cephalomedullary nail) into a medullary cavity of the bone and implanting a locking screw (e.g., a lag screw) into the bone. In such embodiments, the device may be configured as a compression screw component and the locking screw and compression screw component engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
[0062] In some embodiments, the bone is a long bone. In some embodiments, the bone is a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus.
[0063] In some embodiments, the intramedullary nail includes a first hole and a second hole distal to and adjacent to the first hole and, during implantation, the lag screw is inserted through the first hole and the compression screw component is inserted through the second hole.
[0064] In some embodiments, the method further includes implanting a support screw into the bone through a hole in the intramedullary nail that is distal to the compression screw component and the lag screw.
[0065] In some embodiments, the method further includes inserting a second of the device, which may be configured as a suture anchor, into bone to secure the soft tissue to the bone, thereby treating the soft tissue. In some embodiments, the second said device (e.g., as a suture anchor) includes a suture. In some embodiments, the method includes implanting a plurality of the devices (e.g., plurality of the devices configured as suture anchors, e.g., from 2-6 suture anchors) into the bone to secure the soft tissue to the bone. In some embodiments, the method further includes attaching the suture of at least one of the suture anchors to the soft tissue. In some embodiments, the method further includes securing at least one of the suture anchors by way of the suture to a different one of the suture anchors to further secure the soft tissue to the bone.
[0066] In embodiments of any preceding aspect, a) the unitary body includes an internal diameter from about 1 .25 mm to about 25 mm; b) the proximal region includes an inner diameter of from about 3 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; c) the central region includes 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; d) the distal region includes an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; and / or e) the proximal region, the central region, and the distal region include 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.
[0067] In some embodiments, the outer diameter from the proximal end to the distal end is constant. Alternatively, the outer diameter of the proximal region is greater than the outer diameter of the central and distal regions.
[0068] In embodiments of any preceding aspect, the device of the first aspect has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, e.g., about 10-150 mm, e.g., about IQ- 20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160- 180 mm, or about 175-180 mm, e.g., about 10 mm, about 20 mm, about 25 mm, about 50 mm, about 75, about 90 mm, about 100 mm, about 125 mm, about 150 mm, or about 180 mm). In some embodiments, the proximal region includes a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 mm to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm). In some embodiments, the central region includes a length of from about 5 mm to about 150 mm (e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm). In some embodiments, e.g., in which the devices include only a central region, the central region has a length from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about 10-20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160- 180 mm, about 175-190 mm, about 175-200 mm, about 180-200 mm, or about 190-200 mm, e.g., about 10 mm, about 20 mm, about 25 mm, about 50 mm, about 75, about 90 mm, about 100 mm, about 125 mm, about 150 mm, about 175 mm, or about 200 mm). In some embodiments, the distal region includes a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0069] In some embodiments, the proximal region includes a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 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, 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 4.0 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of the proximal region is about 2.5 mm, in which, optionally, the wall thickness of the proximal region is about 4.5 mm. In some embodiments, the central region includes a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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
[0070] 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
[0071] 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
[0072] 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
[0073] 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
[0074] 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
[0075] 4.7 mm, about 4.8 mm, about 4.9 mm, about 5.0 mm, about 5.1 mm, about 5.2 mm, about 5.3 mm, about
[0076] 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of the central region is about 0.7 mm. In some embodiments, the distal region includes a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 mm to about 2.0 mm, about 1 .0 mm to about 2.0 mm, about 0.2 mm to 0.80 mm, about
[0077] 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of the distal region is about 0.7 mm. In some embodiments, the central region and the distal region include the same wall thickness.
[0078] In some embodiments, the distal end of the distal region includes a blunt and / or tapered edge. In some embodiments, the distal end of the distal region includes from 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes), in which optionally the distal region includes 3 milling flutes.
[0079] In some embodiments, the proximal region, central region, and / or distal region include an internal thread. In some embodiments, the unitary body includes an external thread; in which, optionally, one or more of the proximal region, central region, and / or distal region, if present, include an external thread. In some embodiments, the internal and / or external thread has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about
[0080] 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about
[0081] 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 11 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about
[0082] 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11 .5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm). In some embodiments, the internal or external thread is formed from protrusions, grooves, waves, or a mesh. In some embodiments, the protrusions, grooves, or waves are at from about 1 to about 360 points per 360° (e.g., at 4-20 equidistant points along the circumference of the proximal, central, and / or distal region). In some embodiments, the internal and / or external thread includes a continuous thread or non- continuous thread. In some embodiments, the internal and / or external thread is broken by an opening. In some embodiments, the non-continuous thread includes a gap, in which optionally the gap has a length from about 0.5 mm to about 30 mm. In some embodiments, the internal and / or external thread is broken by the plurality of openings.
[0083] In some embodiments, the distal end includes a blunt and / or tapered edge. In some embodiments, the distal end includes a milling flute. In some embodiments, the distal end includes from 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes); in which, optionally, the distal end includes 3 milling flutes. In some embodiments, the distal end includes from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the tapered distal end is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting the distal end of the device. In some embodiments, the opening at the distal end to the internal channel may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a solid dose of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, the distal end does not have an opening to the internal channel. In some embodiments, the proximal end includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver.
[0084] In some embodiments, the method includes introducing a volume of the biomaterial of from about 1 ml to about 20 ml (e.g., from about 1 ml to about 2 ml, from about 1 ml to about 3 ml, from about 1 ml to about 4 ml, from about 1 ml to about 5 ml, from about 1 ml to about 10 ml, from about 5 ml to about 10 ml, from about 5 ml to about 15 ml, from about 10 ml to about 15 ml, from about 15 ml to about 20 ml, or from about 15 ml to about 20 ml) to the internal channel at the proximal end of the device.
[0085] In some embodiments, the volume of the biomaterial is about 2.5 ml, about 5 ml, or about 10 ml. In some embodiments, the method includes injecting a volume of hydrating fluid into the internal channel of the device, in which the device has been pre-loaded with biomaterial (e.g., a solid biomaterial) to yield a combined total volume of hydrating fluid and biomaterial of from 1 ml to about 20 ml, wherein optionally the total volume is about 2.5 ml, about 5 ml, or about 10 ml. In some embodiments, the biomaterial is delivered to the bone surrounding both device 100 and a locking screw (e.g., a lag screw) in a compression assembly to secure both device 100 and the locking screw to the bone upon biomaterial hardening.
[0086] In some embodiments, the method further includes inserting a screw including a length through the internal channel at the proximal end of the device (e.g., before or after hardening of the biomaterial).
[0087] In some embodiments, the method further includes aligning the screw with an internal thread.
[0088] In some embodiments, the length of the screw traverses a 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; in which, optionally, tightening the screw in the distal cortex causes bone compression.
[0089] In some embodiments, tightening the screw in the distal cortex does not cause rotation of the device.
[0090] The methods of the disclosure can also include extracting the device of the first aspect from a bone, e.g., by inserting a distal region of an extraction tool into the internal channel of the device and twisting the extraction tool to remove the device from the bone. In some embodiments, twisting the extraction tool does not cause rotation of the device. In some embodiments, twisting of the extraction tool may be clockwise or counterclockwise to remove the device from the bone. In some embodiments, prior to extracting the device, the method includes removing a screw from the device. In some embodiments, the extraction tool threadedly engages with the internal protrusions (e.g., an internal thread) of the device.
[0091] In some embodiments, the kit further includes a suture anchor. Optionally, the suture anchor is a soft tissue suture anchor. In some embodiments, the kit further includes an intramedullary pin. In some embodiments, the kit further includes a nail device. In some embodiments, the kit further includes a spinal attachment device. The suture anchor, intramedullary pin, nail device, and / or spinal attachment device can be made from a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. The suture anchor, intramedullary pin, nail device, and / or spinal attachment device can also be 3D printed using these materials or others.
[0092] Definitions
[0093] To facilitate an understanding of this disclosure, a number of terms are defined below. Terms defined herein have meanings as commonly understood by a person of ordinary skill in the areas relevant to the disclosure. Terms such as “a,” “an,” and “the” are not intended to refer to only a singular entity; but include the general class of which a specific example may be used for illustration. The terminology herein is used to describe specific embodiments of the disclosure, but their usage does not limit the disclosure, except as outlined in the claims.
[0094] As used herein, the term “about” refers to a value that is within 10% above or below the value being described.
[0095] As used herein, any values provided in a range of values include both the upper and lower bounds, and any values contained within the upper and lower bounds.
[0096] The term “biomaterial,” as used herein, refers to any adhesive biocompatible substance, of natural or synthetic origin, suitable for introduction into living tissue for a medical purpose (e.g., therapeutic, diagnostic, or preventative use) and used to fill a void, affix, join, treat, heal or regenerate bone.
[0097] The term “bone defect,” as used herein, refers to any bone deficient region, such as a void, gap, recess, or other discontinuity in a bone. A bone defect can be artificially or naturally established, and can occur, for example, due to disease or trauma. Thus, a bone defect can occur as a consequence of pathologic or inflammatory diseases, formation and / or removal of a bone tumor, a surgical intervention, a congenital defect, or a bone fracture, and the like. For example, in the case of certain diseases, such as bone tumors, the bone defect may be artificially established due to removal of the tumor tissue. A bone defect may be an intertrochanteric fracture. The term “bony defect” is also intended to include anatomical sites where augmentation to a bony feature is desired by the patient in the absence of disease or trauma, such as in elective cosmetic surgery. Thus, the “defect” can be one that is subjectively perceived by the patient, and where augmentation of the bone deficient region is desired.
[0098] As used herein, the term “milling flute” refers to one or more cutting edges that cut a piece of a material (e.g., bone tissue) as the milling flute rotates. A milling flute may be a cutting projection that is integral to the device of the disclosure.
[0099] The term “mesh,” as used herein, refers to a structure characterized by having one or more openings arranged parallel, diagonally, vertically, spirally, helically, relative to the longitudinal direction of the device.
[0100] The term “opening,” as used herein, refers to any orifice, aperture, void, gap, or hole characterized by the absence of a particular material or structure that defines the region of the device in which the opening is disposed. The “opening” may be round or take any overall shape or geometry outlined by edges that bound the opening (e.g., diamond shaped). Alternatively, an “opening” may be helical.
[0101] The term “pellet,” as used herein, refers to any material having a cylindrical, rounded, square, spherical, tubular, or any other shape. The term “pellet” does not impart any specific shape. The “pellet” may be formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-100 MPa, about 25-50 MPa, or about 125-150 MPa).
[0102] The term “region,” as used herein, refers to any section of the unitary body disposed between the proximal end and distal end of the device and that may include an external thread or a plurality of openings having one type of shape (e.g., helical slits or diamond-shaped holes) or a variety of shapes. The bounds of the “region” are defined by the proximal and distal ends. The “region” may include a proximal region, a central region, and / or a distal region, such that the assigned region is referenced from the proximal end of the device. The device may include one, two, or three of the regions. For example, a device without an external protrusion that includes, from a proximal end to a distal end, a first plurality of openings (e.g., helical openings) and a second plurality of openings (e.g., non-helical openings) has two regions: a proximal region including the first plurality of openings and a distal region including the second plurality of openings.
[0103] As used herein, the term “toroidal flow” refers to rotational flow of a fluid material induced as the fluid material (e.g., a biomaterial, e.g., a biomaterial with non-Newtonian fluid dynamic characteristics) moves through and / or around a device of the disclosure. The “toroidal flow” may be a rotational flow along the longitudinal, central axis of the internal channel whose flow pattern resembles the shape of a torus, a toroid, or a donut. The flow pattern directs the fluid from an edge toward the center axis then back toward the edge. The “toroidal flow” may occur along the internal channel of the device and / or as fluid exits the openings of the device.
[0104] By “treating” or “treatment” is meant the medical management of a patient with the intent that an amelioration, repair, or prevention of an injury or disease, pathological condition, or disorder will result. This term includes active treatment, that is, treatment directed specifically toward improvement of the injury or disease, pathological condition, or disorder, and also includes causal treatment, that is, treatment directed toward removal of the cause of the injury or disease, pathological condition, or disorder. In addition, this term includes palliative treatment, that is, treatment designed for the relief of symptoms rather than the curing of the injury or disease, pathological condition, or disorder; preventive treatment, that is, treatment directed to prevention of the injury or disease, pathological condition, or disorder; and supportive treatment, that is, treatment employed to supplement another specific therapy directed toward the improvement of the injury or disease, pathological condition, or disorder.
[0105] As used herein, the term “unitary” refers to an undivided body which is of a one-piece construction (e.g., a unitary body that can be manufactured as a single piece, e.g., 3D printed in its entirety).
[0106] Brief Description of the Drawings
[0107] FIGs. 1A-1H are images showing device 100 of the disclosure with unitary body 101 , proximal end 102, distal end 103, proximal region 104 with thread 110 in the exterior of proximal region 104, central region 105, distal region 106, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region 106. Internal channel 109 runs through the center of unitary body 101. FIGs. 1A-1 H show device 100 in various orientations. FIG 1 A is a frontal view. FIG. 1 B is a back view. FIG. 1C is a left view. FIG. 1 D is a right view. FIG. 1 E is a top view. FIG. 1 F is a bottom view. FIG. 1 G is a front cross-sectional view taken along line A-A as shown in FIGs. 1 C, 1 D, and 1 E. FIG. 1 H is a diametrical view. Internal channel 109 is shown in FIGs. 1 E-1 G, from top, bottom, and front cross-sectional views, respectively. Internal channel 109 is also visible through first plurality of openings 107 and second plurality of openings 108 of FIGs. 1A-1 D and 1 H. Device 100 can include notches 111.
[0108] FIG. 2 is an image showing device 100 of the disclosure with thread 110 in the exterior of proximal region 104. Also shown are proximal 102 and distal ends 103, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region 106. Thread 110 in proximal region 104, which is configured to engage with a locking screw (e.g., a lag screw), as shown in FIG. 3.
[0109] FIG. 3 is an image showing an intertrochanteric antegrade nail system, in which device 100 of the disclosure is used as a compression screw component engaged with a locking screw (e.g., lag screw) to form a compression assembly in conjunction with an intramedullary nail (e.g., a cephalomedullary nail).
[0110] FIGs. 4A-4M are images showing device 400 of the disclosure with unitary body 401 , proximal end 402, distal end 403, proximal region 404 with thread 410 in the exterior of proximal region 404, distal region 406, and plurality of openings 412 in distal region 406. Internal channel 409 runs through the center of unitary body 401 . FIGs. 4A-4M show device 400 in various orientations. FIG 4A is a frontal view. FIG. 4B is a back view. FIG. 4C is a left view. FIG. 4D is a right view. FIG. 4E is a top view. FIG. 4F is a bottom view. FIG. 4G-4K is a front cross-sectional view taken along line A-A as shown in FIGs. 4C, 4D, and 4E. FIG. 4L is a diametrical view. FIG. 4M is an oblique view. Internal channel 409 is shown in FIGs. 4E-4M, from top, bottom, front cross-sectional, front-cross sectional, front-cross sectional, front- cross sectional, front-cross sectional, diametrical, and oblique views, respectively. Internal channel 409 is also visible through plurality of openings 412 of FIGs. 4A-4D. FIGs. 4H-4K and 4M show device 400 with internal protrusion(s) 413 (e.g., internal thread) that is / are located within internal channel 409. FIG. 4I-4K show the front cross-sectional view, and FIG. 4M shows the oblique view, respectively. Device 400 can optionally include notches 411. Device 400 can optionally include pellets of biomaterial 414 pre-loaded into internal channel 409, as shown in FIGs. 4I-4K. Pellets of biomaterial 414 are pictured in FIGs. 4I-4K with a cylindrical shape; however, other shapes can also be used and are envisioned within the scope of the disclosure.
[0111] FIG. 5 is an image showing device 500 of the disclosure with unitary body 501 , proximal end 502, distal end 503, proximal region 504, distal region 506, first plurality of openings 507 in proximal region 504, second plurality of openings 508 in distal region 506, and without a thread in the exterior of proximal region 504. Device 500 also contains internal channel 509 running through unitary body 501 .
[0112] FIGs. 6A-6I are images showing device 600 of the disclosure with unitary body 601 , proximal end 602, distal end 603, central region 605, plurality of openings 612 in central region 605, and without a thread in the exterior of the device. Internal channel 609 runs through the center of unitary body 601 . FIGs. 6A-6I show device 600 in various orientations. FIG 6A is a frontal view. FIG. 6B is a back view. FIG. 6C is a left view. FIG. 6D is a right view. FIG. 6E is a top view. FIG. 6F is a bottom view. FIG. 6G is a front cross-sectional view taken along line A-A as shown in FIGs. 6C, 6D, and 6E. FIG. 6H is a diametrical view. FIG. 6I is an oblique view. Internal channel 609 is shown in FIGs. 6E-6I, from top, bottom, front cross-sectional, diametrical, and oblique views, respectively. Internal channel 609 is also visible through plurality of openings 612 of FIGs. 6A-6D. FIGs. 6G and 6I show device 600 with internal protrusion(s) 613 (e.g., an internal thread) that is / are located within internal channel 609. FIG. 6G shows the front cross-sectional view, and FIG. 6I shows the oblique view. Internal protrusion(s) 613 (e.g., internal thread) is / are also visible through plurality of openings 612 of FIG. 6H. Device 600 can optionally include notches 611 .
[0113] FIG. 7 is an image showing an X-ray radiograph of a pelvis and femur of a subject with a mockup of a sliding hip screw system for treating proximal femur fractures with a representation of device 100 of the disclosure in place of the compression screw component. The sliding hip screw system includes a bone plate including a barrel, a lag screw, device 100, and four bone screws.
[0114] FIGs. 8A-8D are images showing device 800 of the disclosure with unitary body 801 , proximal end 802, distal end 803, central region 805, plurality of openings 812 in central region 805, and without a thread in the exterior of the device. Internal channel 809 runs through the center of unitary body 801 . FIGs. 8A-8D show device 800 in various orientations. FIG. 8A is a frontal view. FIG. 8B is a front cross- sectional view taken along line A-A, as shown in FIG. 8A. FIG. 8C is an oblique view. Device 800 can optionally include pellets of biomaterial 814 pre-loaded into internal channel 809, as shown in FIG. 8B. FIG. 8D shows device 800 next to device 400 to demonstrate size differences.
[0115] FIG. 9 is an image showing an X-ray radiograph of a humerus and glenoid of a subject with a mock-up of a suture anchor system for repair of a rotator cuff with a representation of three of device 800 of the disclosure in place of the suture anchors. Detailed Description
[0116] Featured herein are devices, systems, kits, and methods of use thereof for bone repair, bone stabilization, soft tissue repair, soft tissue stabilization, and / or implant fixation. In some embodiments, the devices, systems, and methods herein described are useful for treating a bone defect (e.g., a bone fracture) or a soft tissue defect (e.g., a strained ligament) or for implant fixation by installing at least one of the devices described herein, e.g., using the systems, kits, and / or methods described herein. In some embodiments, the devices, systems, kits, and methods can be used to deliver a biomaterial to bone. A biomaterial can be used to repair a bone or soft tissue defect, to stabilize weak or insufficient bone or soft tissue, or to stabilize implanted hardware or prosthesis. The devices and methods herein described can be used to provide uniform biomaterial delivery to produce robust adhesion between an implant (e.g., an implantable screw) and a bone tissue. Furthermore, the devices and methods overcome challenges associated with the repair of weak or deficient bone or soft tissue and bone augmentation using injected biomaterials (e.g., biomaterials with non-Newtonian fluid dynamic characteristics).
[0117] Devices for bone and soft tissue repair and reinforcement
[0118] Devices of the disclosure are implants that can be used for multiple purposes, including in the repair of bone and soft tissue defects. The devices are configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of a device). Once inserted, the device can be used to uniformly deliver a biomaterial to the bone, secure the bone structure, and promote bone repair and / or healing. Similarly, once inserted, the device can be used to uniformly deliver a biomaterial to the bone, secure the soft tissue to the bone, and promote soft tissue repair and / or healing. The devices can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate, a soft tissue suture anchor, an intramedullary pin, a nail, screw, or other similar hardware, and a spinal attachment device.
[0119] Device Body
[0120] The device has a unitary cylindrical body. The device includes one or more regions disposed between a proximal end and distal end of the device such that each region includes an external thread and / or a plurality of openings. In some embodiments, the device may include a proximal region, a distal region, and / or a central region disposed therebetween, at least one or two of which may be absent. In some embodiments, the device includes a proximal region, central region, and distal region. In some embodiments, the device includes a proximal region and a distal region while the central region is absent. In some embodiments, the device includes a central region while the proximal region and distal region are absent. The device includes an internal channel that extends longitudinally through the unitary body. The device includes a plurality of openings. The device may include a first plurality of openings and a second plurality of openings, where the first plurality of openings has a different shape than the second plurality of openings. For example, the proximal region may include a first plurality of openings (e.g., helical openings) and the distal region may include a second plurality of openings (e.g., non-helical openings). An external thread may be located at the proximal region of the device. The device may not include an external thread. The device may be configured as a compression screw component to configure together with a lag screw to create compression (e.g., as a compression screw assembly). The device may be configured as a fastener. For example, the device may be configured as a suture anchor. The external surface of the unitary body (e.g., the proximal, distal, and / or central regions) may be textured (i.e., rough), e.g., having a roughness of between Ra = about 1 micron to Ra = about 5 and microns (e.g., about 1-2 microns, about 1 .5-3 microns, about 2-3 microns, about 2.5-5 microns, about 3-4 microns, or about 4-5 microns, e.g., about 1 microns, 1 .5 microns, 2 microns, 2.5 microns, about 3.5 microns, e.g., about 3.6 microns, about 4 microns, 4.5 microns, or about 5 microns). The surface of the device may be textured, or only one or more parts thereof. For example, one or more of the proximal, central, or distal regions may be textured. The rough surface creates a higher surface area which is beneficial for the adhesive properties of the biomaterial. Enhanced interaction with the biomaterial leads to better adhesion with the bone and interdigitation with the implant for better fixation of the implanted device (e.g., improved osseointegration in the area of the implanted device).
[0121] The internal channel includes an internal surface. The internal surface may be smooth or textured (i.e., rough), e.g., including at least one internal protrusion. The internal channel may be straight, curved, radial, or helical, depending on the implantable device to be used with the present device.
[0122] In some embodiments, the device has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, about 10 to about 50 mm, about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from about 160 to about 180 mm, or from about 175 to about 180 mm, from about 10 mm to about 110 mm, from about 20 mm to about 110 mm, from about 25 mm to about 110 mm, from about 30 mm to about 1 10 mm, from about 35 mm to about 110 mm, from about 40 mm to about 1 10 m, from about 45 mm to about 1 10 mm, from about 50 mm to about 1 10 mm, from about 55 mm to about 110 mm, from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 110 mm, from about 90 mm to about 110 mm, from about 95 mm to about 1 10 mm, from about 100 mm to about 1 10 mm, from about 105 mm to about 110 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, 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, about 1 10 mm, about 111 mm, about 1 12 mm, about 1 13 mm, about 114 mm, about 1 15 mm, about 1 16 mm, about 117 mm, about 118 mm, about 119 mm, about 120 mm, about 121 mm, about 122 mm, about 123 mm, about 124 mm, about 125 mm, about 126 mm, about 127 mm, about 128 mm, about 129 mm, about 130 mm, about 131 mm, about 132 mm, about 133 mm, about 134 mm, about 135 mm, about 136 mm, about 137 mm, about 138 mm, about 139 mm, about 140 mm, about 141 mm, about 142 mm, about 143 mm, about 144 mm, about 145 mm, about 146 mm, about 147 mm, about 148 mm, about 149 mm, about 150 mm, about 151 mm, about 152 mm, about 153 mm, about 154 mm, about 155 mm, about 156 mm, about 157 mm, about 158 mm, about 159 mm, about 160 mm, about 161 mm, about 162 mm, about 163 mm, about 164 mm, about 165 mm, about 166 mm, about 167 mm, about 168 mm, about 169 mm, about 170 mm, about 171 mm, about 172 mm, about 173 mm, about 174 mm, about 175 mm, about 176 mm, about 177 mm, about 178 mm, about 179 mm, or about 180 mm). In some embodiments, the device has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm). In some embodiments, the device has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, 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).
[0123] In some embodiments, the device is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. The device can also be 3D printed using these materials or others.
[0124] In some embodiments, the device is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets. In some embodiments, the solid dose of biomaterial is formed by compressing a powder of the biomaterial at a pressure of from about 10 to about 150 MPa (e.g., about 10-140 MPa, about 10-125 MPa, about 10-100 MPa, about 10-75 MPa, about 10-50 MPa, about 10-25 MPa, about 10-20 MPa, about 25-50 MPa, about 50-100 MPa, about 50-150 MPa, about 125-150 MPa, e.g., about 10 MPa, about 20 MPa, about 30 MPa, about 40 MPa, about 50 MPa, about 60 MPa, about 70 MPa, about 80 MPa, about 90 MPa, about 100 MPa, about 1 10 MPa, about 120 MPa, about 130 MPa, about 140 MPa, or about 150 MPa). In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes a calcium phosphate, phosphoserine, phosphocreatine, a calcium silicate, or combinations thereof. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes from about 65 to about 85% (e.g., about 65-80%, about 65-75%, about 65-70%, about 70-85%, about 70-80%, about 75-85%, about 80-85%, e.g., about 65%, about 66%, about 67%, about 68%, about 69%, about 70%, about 71 %, about 72%, about 73%, about 74%, about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81 %, about 82%, about 83%, about 84%, or about 85%) calcium phosphate by weight. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes from about 15 to about 35% (e.g., about 15-30%, about 15-25%, about 15-20%, about 20-35%, about 25-35%, about 30-35%, about 20-30%, about 25-30%, about 22-27%, e.g., 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%, or about 35%) phosphoserine or phosphocreatine by weight. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) includes from about 0.2 to about 2.0% (e.g., about 0.2-1.8%, about 0.2-1 .5%, about 0.2-1 .3%, about 0.2-1 .0%, about 0.2-0.8%, about 0.2- 0.5%, about 0.2-0.3%, about 0.5-2.0%, about 0.5-1 .5%, about 0.5-1 .0%, about 1 .0-2.0%, about 1 .0-1 .5%, about 1.5-2.0%, e.g., about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.1 %, about 1.2%, about 1.3%, about 1.4%, about 1.5%, about 1 .6%, about 1 .7%, about 1 .8%, about 1 .9%, or about 2.0%) calcium silicate by weight. In some embodiments, the solid dose biomaterial (e.g., in the form of pellets) has a density of from about 1.20 to about 1 .80 g / cm3(e.g., about 1 .20-1 .75 g / cm3, about 1 .20-1 .70 g / cm3, about 1 .20-1 .60 g / cm3, about 1 .20- 1 .50 g / cm3, about 1 .20-1 .40 g / cm3, about 1 .20-1 .30 g / cm3, about 1 .20-1 .25 g / cm3, about 1 .30-1 .80 g / cm3, about 1 .30-1 .50 g / cm3, about 1 .5-1 .8 g / cm3, e.g., about 1 .20 g / cm3, about 1 .25 g / cm3, about 1 .30 g / cm3, about 1 .35 g / cm3, about 1 .40 g / cm3, about 1 .45 g / cm3, about 1 .5 g / cm3, about 1 .55 g / cm3, about 1 .60 g / cm3, about 1 .65 g / cm3, about 1 .70 g / cm3, about 1 .75 g / cm3, or about 1 .80 g / cm3). Structural and chemical features of the solid dose biomaterial are described in European Application No. EP24165054.8, herein incorporated by reference in its entirety.
[0125] Proximal Region
[0126] In some embodiments, the device includes a proximal region that has a proximal end, a distal end, and a proximal opening to the internal channel.
[0127] In some embodiments, e.g., embodiments that are preferentially disposed for use as compression assemblies in a system for treating proximal femur defects, the proximal region includes an external thread configured to engage with a locking screw (e.g., a lag screw). In some embodiments, the compression screw component and lag screw have a complementary pitch, e.g., of between 0.25 and 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 1 1 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 1 1 mm, about 11 .5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm). The proximal region not including an external thread may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of the proximal region, e.g., the exterior of the proximal region, an interior of the proximal region, and / or interior walls of the openings of the proximal region.
[0128] In some embodiments, the proximal region has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of proximal region is smaller than, larger than, or equal to the outer diameter of central region.
[0129] In some embodiments, the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 1 1 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 than, larger than, or equal to the inner diameter of the central region and / or distal region.
[0130] In some embodiments, the proximal region has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0131] In some embodiments, the proximal region has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 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, 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 4.0 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of the proximal region is about 2.5 mm, in which, optionally, the wall thickness of the proximal region is about 4.5 mm. In certain embodiments, the wall thickness of the proximal region is smaller than, larger than, or equal to the wall thickness of the central region and / or the distal region.
[0132] In some embodiments, the proximal region has a plurality of openings (e.g., slits or holes). In some embodiments, the proximal region does not have openings other than the opening to the internal channel. In some embodiments, the plurality of openings in the proximal region are configured to disperse a biomaterial placed into or injected into the internal channel to an area surrounding the unitary body.
[0133] In some embodiments, the proximal region includes a plurality of openings (e.g., slits or holes). In some embodiments, the plurality of openings are helical slits. In some embodiments, the helical slits are continuous along a length of the proximal region. In some embodiments, the plurality of openings includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of the proximal region.
[0134] In some embodiments, the plurality of openings are non-helical slits. In some embodiments, the plurality of openings are holes dispersed (e.g., uniformly, with a distribution gradient, randomly, etc.) along a length of the proximal region. In some embodiments, the plurality of openings has an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. In some embodiments, the plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
[0135] Central Region
[0136] The device includes a central region that has a proximal end and a distal end. In some embodiments, the device only includes the central region. In other embodiments, the central region of the device is disposed between a proximal region and a distal region.
[0137] In some embodiments, the central region has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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 includes an outer diameter that is smaller than, larger than, or equal to the outer diameter of the proximal and distal regions.
[0138] In some embodiments, the central region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 1 1 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 includes an inner diameter that is smaller than, larger than, or equal to the inner diameter of the proximal and distal regions.
[0139] In some embodiments, the central region has a length of from about 5 mm to about 150 mm (e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm). In some embodiments, e.g., in which the devices include only a central region, the central region has a length from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about I Q- 20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160-180 mm, about 175-190 mm, about 175-200 mm, about 180-200 mm, or about 190-200 mm, e.g., about 10 mm, about 20 mm, about 25 mm, about 50 mm, about 75, about 90 mm, about 100 mm, about 125 mm, about 150 mm, about 175 mm, or about 200 mm).
[0140] In some embodiments, the central region has a wall thickness of from 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of the central region is about 0.7 mm. In some embodiments, the central region and the distal region include the same wall thickness. The central region may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of the central region, e.g., the exterior of the central region, an interior of the central region, and / or interior walls of the openings of the central region. In some embodiments, the central region has a plurality of openings (e.g., slits or holes). In some embodiments, the central region does not have openings other than the opening to the internal channel. In some embodiments, the plurality of openings in the central region are configured to disperse a biomaterial placed into or injected into the internal channel to an area surrounding the unitary body.
[0141] In some embodiments, the central region includes a plurality of openings (e.g., slits or holes). In some embodiments, the plurality of openings are helical slits. In some embodiments, the helical slits are continuous along a length of the central region. In some embodiments, the plurality of openings includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of the central region.
[0142] In some embodiments, the plurality of openings are non-helical slits. In some embodiments, the plurality of openings are holes dispersed (e.g., uniformly, with a distribution gradient, randomly, etc.) along a length of the central region. In some embodiments, the plurality of openings has an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. In some embodiments, the plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
[0143] Distal Region
[0144] In some embodiments, the device includes a distal region that has a proximal end, a distal end, and a distal opening to the internal channel.
[0145] In some embodiments, distal region has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of distal region is smaller than, larger than, or equal to the outer diameter of central region.
[0146] In some embodiments, distal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from 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 distal region is smaller than, larger than, or equal to the inner diameter of central region.
[0147] In some embodiments, the distal region has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0148] In some embodiments, the distal region has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of the distal region is about 0.7 mm. In some embodiments, the central region and the distal region include the same wall thickness.
[0149] The distal region may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of the distal region, e.g., the exterior of the distal region, an interior of the distal region, and / or interior walls of the openings of the distal region.
[0150] In some embodiments, the distal end of distal region has a blunt edge. In some embodiments, the distal end of distal region has a tapered edge. In some embodiments, the distal end of the distal region has at least one or a plurality of milling flutes, notches, and / or elongated tips.
[0151] In some embodiments, the distal region has a plurality of openings (e.g., slits or holes). In some embodiments, the distal region does not have openings other than the opening to the internal channel. In some embodiments, plurality of openings in the distal region are configured to disperse a biomaterial placed into or injected into the internal channel to an area surrounding the unitary body.
[0152] In some embodiments, the distal region includes a plurality of openings (e.g., slits or holes). In some embodiments, the plurality of openings are helical slits. In some embodiments, the helical slits are continuous along a length of the distal region. In some embodiments, the plurality of openings includes 2- 10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of the distal region. In some embodiments, the plurality of openings are non-helical slits. In some embodiments, the plurality of openings are holes dispersed (e.g., uniformly, with a distribution gradient, randomly, etc.) along a length of the distal region. In some embodiments, the plurality of openings have an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. In some embodiments, the second plurality of openings includes segmented slits, longitudinal slits, circumferential slits, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes.
[0153] Openings
[0154] A device may have multiple pluralities of openings, including proximal and distal openings to the internal channel, but also a plurality of openings in the outer surface of the device. The proximal region, central region, and / or distal region may include at least one opening. In some embodiments, the openings extend from one region into at least one other, for example an opening in the central region may extend into the proximal region and / or the distal region. In some embodiments, an opening may extend from the proximal end of the device to the distal end of the device. In some embodiments in which at least one opening extends from the proximal end to the distal end, the unitary body of the device (e.g., a plurality of segments separated by a plurality of openings, e.g., slits) may be connected by at least one extendable arm. The plurality of openings in a region are of the same shape. In some embodiments, the plurality of openings is dispersed along a length of the region from the proximal end of the region to the distal end of the region. In some embodiments, the device includes a first plurality of openings in one region and a second plurality of openings in a second region, wherein the first plurality of openings is a different shape than the second plurality of openings.
[0155] In some embodiments, the plurality of openings are slits or holes. In some embodiments, the plurality of openings includes helical slits, segmented slits, longitudinal slits, or circumferential slits. In some embodiments, the openings include circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes.
[0156] The proximal, central, and distal regions may have different types of openings, e.g., the first plurality of openings in the central regions may be helical openings (e.g., helical slits) that extend the full length of the central region, while the second plurality of openings in the distal region are closed shaped voids that do not extend from a proximal to a distal end of the distal region, e.g., a plurality of holes dispersed along the length of the distal region. Such a difference in openings in the central and distal regions allows greater volumetric expansion of biomaterial adjacent the central region. Many bone defects being centrally located; such a dispersion profile is advantageous for targeting the defect. Alternatively, there may only be one set of openings between the proximal end and distal end of the device, e.g., the device includes only one region, e.g., the central region, that includes a plurality of openings that extend the full length of the central region.
[0157] The plurality of openings may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20), star-shaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. The plurality of openings may be configured to promote toroidal flow in a biomaterial injected into the internal channel, such openings are helical slits. The plurality of openings in a region may additionally induce toroidal flow in the volume of biomaterial as it flows out of the openings and into the adjacent bone tissue. The toroidal flow can reduce flow resistance in the biomaterial during injection. A helical slit may be a slit that extends a full length of a region, e.g., the central region, where a distal end of the helical slit meets the proximal end of the distal region at a point that is not directly opposite the proximal end of the helical slit.
[0158] The plurality of openings can also contribute to reducing flow resistance in the internal channel. Without wishing to be bound by theory, biomaterial in a fluidic state rotates around the center axis of the internal channel, so less friction in the center of the fluid biomaterial mass arises. Friction of biomaterial at an inner wall of the internal channel would restrict intrusion through the internal channel. The plurality of openings allow a decrease in resistance as material exits and creates a rotational force to facilitate flow of the biomaterial along the longitudinal, central axis of the internal channel.
[0159] In some embodiments, the plurality of openings includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200).
[0160] In some embodiments, the device includes a plurality of openings, wherein the plurality of openings comprises a first plurality of openings and a second plurality of openings, and wherein the first plurality of openings has a different shape than the second plurality of openings. In some embodiments, the first plurality of openings includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13,
[0161] 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100, or, e.g., about 4 helical slits). In some embodiments, the second plurality of openings includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about
[0162] 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings).
[0163] In some embodiments, the openings include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
[0164] In some embodiments, the openings include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
[0165] In some embodiments, the openings include slits, in which the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm). In some embodiments, the plurality of openings are helical slits. In some embodiments, the helical slits are continuous along a length of a region. In some embodiments, the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30- 60 mm, about 50-100 mm, about 40-80 mm, about 50-70 mm, about 75-100 mm, about 80-100 mm, about 80-90 mm, or about 90-100 mm, e.g., 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 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, e.g., 51 .5 mm). In some embodiments, the helical slits have a number of turns per unit length of about 0.1 to 5 turns / cm (e.g., from about 0.1 to 0.2 turns / cm, about 0.1 to 0.3 turns / cm, about 0.1 to 0.4 turns / cm, about 0.1 to 0.5 turns / cm, about 0.25 to 0.5 turns / cm, about 0.3 to 0.6 turns / cm, about 0.4 to 0.5 turns / cm, about 0.4 to 0.6 turns / cm, about 0.5 to 0.6 turns / cm, about 0.5 to 0.9 turns / cm, about 0.6 to 0.8 turns / cm, about 0.7 to 0.9 turns / cm, about 0.75 to 1 turns / cm, about 0.75 to 1 .5 turns / cm, about 0.1 to 1 turns / cm, about 1 .1 to 1 .2 turns / cm, about 1 to 2 turns / cm, about 1 to 1 .5 turns / cm, about 1 .3 to 1 .6 turns / cm, about 1 .4 to 1 .8 turns / cm, about 1 .5 to 2 turns / cm, about 1 .8 to 2.2 turns / cm, about 1 .5 to 2.5 turns / cm, about 2 to 2.5 turns / cm, about 2.2 to 2.8 turns / cm, about 2 to 3 turns / cm, about 2 to 4 turns / cm, about 3 to 4 turns / cm, about 2 to 5 turns / cm, about or about 4 to 5 turns / cm, e.g., about 0.1 turns / cm, about 0.2 turns / cm, about 0.3 turns / cm, about 0.4 turns / cm, about 0.5 turns / cm, about 0.6 turns / cm, about 0.7 turns / cm, about 0.8 turns / cm, about 0.9 turns / cm, about 1 .0 turns / cm, about 1 .1 turns / cm, about 1 .2 turns / cm, about 1 .3 turns / cm, about 1 .4 turns / cm, about 1 .5 turns / cm, about 1 .6 turns / cm, about 1 .7 turns / cm, about 1 .8 turns / cm, about 1 .9, about 2 turns / cm, about
[0166] 2.1 turns / cm, about 2.2 turns / cm, about 2.3 turns / cm, about 2.4 turns / cm, about 2.5 turns / cm, about 2.6 turns / cm, about 2.7 turns / cm, about 2.8 turns / cm, about 2.9, about 3 turns / cm, about 4.1 turns / cm, about
[0167] 4.2 turns / cm, about 4.3 turns / cm, about 4.4 turns / cm, about 4.5 turns / cm, about 4.6 turns / cm, about 4.7 turns / cm, about 4.8 turns / cm, about 4.9, about 5 turns / cm, e.g., 0.375 turns / cm). In some embodiments, the plurality of openings includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, the plurality of openings extends through an entire length of a region.
[0168] In some embodiments, the openings are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of a solid dose of the biomaterial (e.g., in the form of pellets).
[0169] In some embodiments, the openings have a cross-sectional dimension (i.e., a width, e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 3 mm, about 4 mm, or about 5 mm).
[0170] In some embodiments, the openings include staggered or straight openings. In some embodiments, a total surface area of openings in a region are from about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of the region.
[0171] The openings are configured for the distribution and delivery of biomaterial to the bone surrounding device. The openings may be configured for the uniform distribution and delivery of biomaterial or configured to distribute and deliver biomaterial at different levels around the outside surface of the device. The porosity of the device, or at regions of the device, determines the distribution and delivery of the biomaterial.
[0172] Threads
[0173] In some embodiments, the device includes a thread or threads, such as internal and / or external threads. The thread may be present in the proximal region, the central region, and / or distal region.
[0174] The thread may be configured to engage with a lag screw of a nail system for treating an intertrochanteric fracture.
[0175] The thread may aid in the placement of implantable devices (e.g., a screw or suture anchor) in the device and / or the use of the device with other components of a delivery system. For example, a component of a delivery system device may thread onto the device.
[0176] In some embodiments, the thread has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 1 1 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 1 1 mm, about 11 .5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm). In some embodiments, the thread is formed from protrusions, grooves, waves, or a mesh. In some embodiments, the internal channel is lined with a mesh so as to form internal threads.
[0177] In some embodiments, the protrusions, grooves, or waves are at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread.
[0178] In some embodiments, the thread is a continuous thread or non-continuous thread. In some embodiments, the thread is broken by at least one opening, e.g., at least one slit or at least one hole. In some embodiments, the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
[0179] In some embodiments, the device includes a thread-like equivalent. A thread-like equivalent is a repeating pattern which allows a second device with threads or thread equivalents to be screwed on and secured. Examples of thread-like equivalents include protrusions that repeat, grooves, mesh, or waves. A thread may be textured.
[0180] Device Ends
[0181] In some embodiments, the distal end of the device can be blunt and / or can be tapered. In some embodiments, the tapered distal end is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting the distal end of the device. In some embodiments, the opening at the distal end to the internal channel may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a pellet of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, the distal end does not have an opening to the internal channel.
[0182] In some embodiments, the distal end includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, the distal end has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes).
[0183] In some embodiments, the distal end includes at least one notch. In some embodiments, the distal end has from 2 to 4 notches (e.g., 2, 3, or 4 notches).
[0184] In some embodiments, the proximal end includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. In some embodiments, the outer diameter from the proximal end to the distal end is constant.
[0185] Grooves
[0186] In some embodiments, in which the device includes from 1 to 70 longitudinal grooves (e.g., from 1 to 2, from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 2 to 6, from 4 to 8, from 5 to 10, from 6 to 12, from 5 to 15, from 10 to 20, from 20 to 40, from 30 to 60, or from 50 to 70 longitudinal grooves). In some embodiments, the longitudinal grooves include a depth of from about 0.15 mm to about 2.5 mm (e.g., from about 0.15 mm to about 0.5 mm, from about 0.15 mm to about 1 mm, from about 0.15 mm to about 1 .5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm, to about 2 mm, from about 1 mm to about 3 mm, from about 2 mm to about 3mm, 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, about 2 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5). In some embodiments, the longitudinal grooves extend from a proximal end of the central region to a distal end of the device, the proximal region, the central region, or the distal region.
[0187] Device 100
[0188] With reference to FIGs. 1A-1 H and FIG. 2, device 100 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation. Device 100 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 100) and can be used as a compression screw component, fastener, or suture anchor. Device 100 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (e.g., device 100 in sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., device 100 in nail system of FIG. 3), a screw, a suture, a prosthesis, or other similar hardware, and as a spinal attachment device. Once inserted, device 100 can be used to uniformly deliver a biomaterial to the bone, secure the bone and / or soft tissue structure, and promote bone and / or soft tissue repair and / or healing. Advantageously, device 100 promotes improved (e.g., increased) distribution of a biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of a defect in the bone.
[0189] Device 100 has unitary body 101 that includes proximal end 102, distal end 103, proximal region 104 with thread 110 in the exterior of proximal region 104, central region 105, distal region 106, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region 106 (see, e.g., FIGs. 1A-1 H and FIG. 2). Device 100 also includes internal channel 109 (see, e.g., FIGs. 1 E- 1 H) that extends longitudinally through unitary body 101 . Device 100 can include notches 11 1. In some embodiments, device 100 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from about 160 to about 180 mm, or from about 175 to about 180 mm, from about 10 mm to about 110 mm, from about 20 mm to about 110 mm, from about 25 mm to about 110 mm, from about 30 mm to about 1 10 mm, from about 35 mm to about 110 mm, from about 40 mm to about 110 m, from about 45 mm to about 1 10 mm, from about 50 mm to about 1 10 mm, from about 55 mm to about 110 mm, from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 1 10 mm, from about 90 mm to about 110 mm, from about 95 mm to about 110 mm, from about 100 mm to about 1 10 mm, from about 105 mm to about 110 mm, about 9 mm, about 10 mm, about 1 1 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 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, about 1 10 mm, about 111 mm, about 1 12 mm, about 1 13 mm, about 114 mm, about 1 15 mm, about 1 16 mm, about 117 mm, about 118 mm, about 119 mm, about 120 mm, about 121 mm, about 122 mm, about 123 mm, about 124 mm, about 125 mm, about 126 mm, about 127 mm, about 128 mm, about 129 mm, about 130 mm, about 131 mm, about 132 mm, about 133 mm, about 134 mm, about 135 mm, about 136 mm, about 137 mm, about 138 mm, about 139 mm, about 140 mm, about 141 mm, about 142 mm, about 143 mm, about 144 mm, about 145 mm, about 146 mm, about 147 mm, about 148 mm, about 149 mm, about 150 mm, about 151 mm, about 152 mm, about 153 mm, about 154 mm, about 155 mm, about 156 mm, about 157 mm, about 158 mm, about 159 mm, about 160 mm, about 161 mm, about 162 mm, about 163 mm, about 164 mm, about 165 mm, about 166 mm, about 167 mm, about 168 mm, about 169 mm, about 170 mm, about 171 mm, about 172 mm, about 173 mm, about 174 mm, about 175 mm, about 176 mm, about 177 mm, about 178 mm, about 179 mm, or about 180 mm). In some embodiments, device 100 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm). In some embodiments, device 100 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, 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). The internal surface of device 100 may be smooth or textured (e.g., rough). Internal channel 109 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 100.
[0190] In some embodiment, device 100 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200).
[0191] In some embodiments, device 100 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 100 can also be 3D printed using these materials or others.
[0192] In some embodiments, distal end 103 can be blunt and / or can be tapered. In some embodiments, distal end 103 has a blunt edge. In some embodiments, distal end 103 has a tapered edge. In some embodiments, distal end 103 has at least one or a plurality of milling flutes, notches, and / or elongated tips. In some embodiments, distal end 103 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 103 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 103 includes at least one notch. In some embodiments, distal end 103 has from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the opening at distal end 103 to internal channel 109 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a pellet of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, the tapered distal end is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 103 of device 100. In some embodiments, distal end 103 does not have an opening to internal channel 109. In some embodiments, proximal end 102 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. In some embodiments, the outer diameter from proximal end 102 to distal end 103 is constant.
[0193] Proximal region of device 100 Device 100 includes proximal region 104 that includes internal channel 109 and thread 110 in the exterior of proximal region 104 (see, e.g., FIGs. 1A-1 H). In some embodiments, proximal region 104 does not have openings other than the opening to internal channel 109 at proximal end 102.
[0194] In some embodiments, proximal region 104 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of proximal region 104 is smaller than, larger than, or equal to the outer diameter of central region 105. In some embodiments, the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 proximal region 104 is smaller than, larger than, or equal to the inner diameter of central region 105.
[0195] In some embodiments, proximal region 104 has a length of from about 2 mm to 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0196] In some embodiments, proximal region 104 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 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, 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 4.0 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of proximal region 104 is about 2.5 mm, in which, optionally, the wall thickness of proximal region 104 is about 4.5 mm. In certain embodiments, the wall thickness of proximal region 104 is smaller than, larger than, or equal to the wall thickness of central region 105.
[0197] Proximal region 104 not including thread 110 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on the exterior of proximal region 104.
[0198] In some embodiments, thread 1 10 located on the exterior of proximal region 104 has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about
[0199] 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about
[0200] 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 11 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm).
[0201] In some embodiments, thread 1 10 located on the exterior of proximal region 104 is formed from protrusions, grooves, waves, or a mesh. In some embodiments, the protrusions, grooves, or waves of thread 110 is at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread. In some embodiments, thread 110 is a continuous thread or non-continuous thread. In some embodiments, thread 110 is broken by at least one opening, e.g., at least one slit or at least one hole. In some embodiments, the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm). Central region of device 100
[0202] Device 100 includes central region 105 that includes a first plurality of openings 107 and internal channel 109.
[0203] In some embodiments, central region 105 has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). Central region 105 includes an outer diameter that is smaller than, larger than, or equal to the outer diameter of proximal region 104 and distal region 106. In some embodiments, central region 105 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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). Central region 105 includes an inner diameter that is smaller than, larger than, or equal to the inner diameter of proximal region 104 and distal region 106.
[0204] In some embodiments, central region 105 has a length of from about 5 mm to 150 mm (e.g., from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
[0205] In some embodiments, central region 105 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of central region 105 is about 0.7 mm. In some embodiments, central region 105 and distal region 106 have the same wall thickness.
[0206] Central region 105 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of central region 105, e.g., the exterior of central region 105, an interior of central region 105, and / or interior walls of the openings of central region 105.
[0207] In some embodiments, first plurality of openings 107 in central region 105 includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100, or , e.g., about 4 helical slits).
[0208] In some embodiments, first plurality of openings 107 in central region 105 include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 75 to about 100 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
[0209] In some embodiments, first plurality of openings 107 in central region 105 include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
[0210] First plurality of openings 107 in central region 105 may be slits, helical slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes. First plurality of openings 107 in central region 105 may be configured to promote toroidal flow in a biomaterial injected into internal channel 109, such first plurality of openings 107 are helical slits. First plurality of openings 107 in central region 105 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 107 and into the adjacent bone tissue. The toroidal flow can reduce flow resistance in the biomaterial during injection. In some embodiments, the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
[0211] In some embodiments, first plurality of openings 107 in central region 105 are helical slits. In some embodiments, the helical slits are continuous along a length of the central region. In some embodiments, the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-70 mm, about 75-100 mm, about 80-100 mm, about 80-90 mm, or about 90-100 mm, e.g., 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 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, e.g., 51 .5 mm). In some embodiments, the helical slits have a number of turns per unit length of between 0.1 and 5 turns / cm (e.g., from about 0.1 to 0.2 turns / cm, about 0.1 to 0.3 turns / cm, about 0.1 to 0.4 turns / cm, about 0.1 to 0.5 turns / cm, about 0.25 to 0.5 turns / cm, about 0.3 to 0.6 turns / cm, about 0.4 to 0.5 turns / cm, about 0.4 to 0.6 turns / cm, about 0.5 to 0.6 turns / cm, about 0.5 to 0.9 turns / cm, about 0.6 to 0.8 turns / cm, about 0.7 to 0.9 turns / cm, about 0.75 to 1 turns / cm, about 0.75 to 1 .5 turns / cm, about 0.1 to 1 turns / cm, about 1 .1 to 1 .2 turns / cm, about 1 to 2 turns / cm, about 1 to 1 .5 turns / cm, about 1 .3 to 1 .6 turns / cm, about 1 .4 to 1 .8 turns / cm, about 1 .5 to 2 turns / cm, about 1 .8 to 2.2 turns / cm, about 1 .5 to 2.5 turns / cm, about 2 to 2.5 turns / cm, about 2.2 to 2.8 turns / cm, about 2 to 3 turns / cm, about 2 to 4 turns / cm, about 3 to 4 turns / cm, about 2 to 5 turns / cm, about or about 4 to 5 turns / cm, e.g., about 0.1 turns / cm, about 0.2 turns / cm, about 0.3 turns / cm, about 0.4 turns / cm, about 0.5 turns / cm, about 0.6 turns / cm, about 0.7 turns / cm, about 0.8 turns / cm, about 0.9 turns / cm, about 1 .0 turns / cm, about 1 .1 turns / cm, about 1 .2 turns / cm, about 1 .3 turns / cm, about 1 .4 turns / cm, about 1 .5 turns / cm, about 1 .6 turns / cm, about 1 .7 turns / cm, about 1 .8 turns / cm, about 1 .9, about 2 turns / cm, about 2.1 turns / cm, about 2.2 turns / cm, about 2.3 turns / cm, about 2.4 turns / cm, about 2.5 turns / cm, about 2.6 turns / cm, about 2.7 turns / cm, about 2.8 turns / cm, about 2.9, about 3 turns / cm, about 4.1 turns / cm, about 4.2 turns / cm, about 4.3 turns / cm, about 4.4 turns / cm, about 4.5 turns / cm, about 4.6 turns / cm, about 4.7 turns / cm, about 4.8 turns / cm, about 4.9, about 5 turns / cm, e.g., 0.375 turns / cm) . In some embodiments, first plurality of openings 107 in central region 105 includes 2-10 helical slits; preferably 4-6 helical slits.
[0212] In some embodiments, device 100 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets. In this embodiment, first plurality of openings 107 in central region 105 may be sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets).
[0213] In some embodiments, first plurality of openings 107 in central region 105 together encompass from between about 20% to 80% (e.g., from about 20% to about 30%, from about 20% to about 65%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total external surface area of central region 105.
[0214] In some embodiments, first plurality of openings 107 in central region 105 extend from one region into at least one other, for example an opening in central region 105 may extend into proximal region 104 and / or distal region 106. Central region 105 may have different types of openings than distal region 106, e.g., first plurality of openings 107 in central region 105 may be helical openings (e.g., helical slits) that extend the full length of central region 105, while second plurality of openings 108 in distal region 106 are closed shaped voids that do not extend from proximal to distal end of distal region 106, e.g., plurality of openings 108 that are holes dispersed along the length of distal region 106 (see, e.g., FIGs. 1A-1 D, 1 H, and 2). Such a difference in openings in the central and distal regions allows greater volumetric expansion of biomaterial adjacent the central region. Given that many bone defects are centrally located, such a dispersion profile is advantageous for targeting the defect.
[0215] Distal region of device 100
[0216] Device 100 includes distal region 106 that includes second plurality of openings 108 and internal channel 109. In some embodiments, distal region 106 does not have openings other than the opening to internal channel 109 at distal end 103.
[0217] In some embodiments, distal region 106 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of distal region 106 is smaller than, larger than, or equal to the outer diameter of central region 105. In some embodiments, distal region 106 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from 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 distal region 106 is smaller than, larger than, or equal to the inner diameter of central region 105.
[0218] In some embodiments, distal region 106 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm
[0219] In some embodiments, distal region 106 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of distal region 106 is about 0.7 mm. In some embodiments, central region 105 and distal region 106 include the same wall thickness.
[0220] Distal region 106 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of distal region 106, e.g., the exterior of distal region 106, an interior of distal region 106, and / or interior walls of the openings of distal region 106.
[0221] Second plurality of openings 108 may have an internal perimeter that is round, square, diamondshaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. Second plurality of openings 108 in distal region 106 may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15, 16, 17, 18, 19, or 20), star-shaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. Second plurality of openings 108 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes. In some embodiments, second plurality of openings 108 in distal region 106 include staggered or straight openings. In some embodiments, second plurality of openings 108 in distal region 106 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, second plurality of openings 108 extend through an entire length of distal region 106. Second plurality of openings 108 in distal region 106 can also contribute to reducing flow resistance in internal channel 109 in combination with first plurality of openings 107 in central region 105. Without wishing to be bound by theory, biomaterial in a fluidic state rotates around the center axis of internal channel 109, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation. The perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
[0222] In some embodiments, second plurality of openings 108 in distal region 106 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings).
[0223] In some embodiments, second plurality of openings 108 in distal region 106 have a cross- sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 3 mm, about 4 mm, or about 5 mm).
[0224] In some embodiments, second plurality of openings 108 in distal region 106 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets). In some embodiments, the opening to internal channel 109 at distal end 103 has a cross-sectional dimension that is narrower than the cross- sectional dimension of the solid dose of the biomaterial. In some embodiments, the tapered distal end 103 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 103 of device 100.
[0225] In some embodiments, second plurality of openings 108 in distal region 106 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of distal region 106.
[0226] With reference to FIGs. 1A-1 H, a particular device 100 has unitary body 101 that includes proximal end 102, distal end 103, proximal region 104 with thread 1 10 in the exterior of proximal region 104, central region 105, distal region 106, second plurality of openings 108 in distal region 106, and notches 1 11. Device 100 also includes internal channel 109 that extends longitudinally through unitary body 101 (see, e.g., FIGs. 1 E-1 H). Device 100 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 100 can also be 3D printed using these materials or others. Device 100 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, e.g., about 50 mm). Proximal region
[0227] 104 has a length of from about 2 mm to 100 mm (e.g., from about 2 mm to about 10 mm, from about 10 mm to about 20 mm, from about 50 to about 75 mm, or from about 73 mm to about 100 mm). Central region 105 has a length of from about 5 mm to 150 mm (e.g., from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 100 to about 150 mm). Distal region 106 has a length of from about 2 mm to about 100 mm (e.g., about 2 mm to about 10 mm, from about 10 mm to about 20 mm, from about 50 to about 75 mm, or from about 75 mm to about 100 mm). Proximal region 104 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 25 mm). Proximal region 104 has an inner diameter of from about
[0228] 1 mm to about 20 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 20 mm). Central region 105 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 25 mm). Central region 105 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 20 mm). Distal region 106 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 25 mm). Distal region 106 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 5 mm, from about 5 mm to about 10 mm, or, e.g., about 20 mm). Proximal region 104 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 4.0 mm to about 5.0 mm, or, e.g., about 2.5 mm, about 3.5 mm, or about 4.5 mm). Central region 105 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 mm to about 2.0 mm, about 1 .0 mm to about 2.0 mm, or about 4.0 mm to 5.0 mm, or, e.g., about 0.7 mm, about 2 mm, or about 4.5 mm). Distal region 106 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 mm to about 2.0 mm, about 1 .0 mm to about 2.0 mm, or about 4.0 mm to 5.0 mm, or, e.g., about 0.7 mm, about 1 .5 mm, or about 4.5 mm). Central region 105 and / or distal region 106 can include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of central region 105 and / or distal region 106, e.g., the exterior of central region 105, an interior of central region 105, and / or interior walls of the openings of central region 105. The internal surface (of the internal channel 109) of device 100 may be smooth or textured (e.g., rough). Internal channel 109 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 100. Thread 110 has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 5 mm to about 10 mm, or, e.g., about 15 mm). Thread 110 is formed from protrusions, grooves, waves, or a mesh. Internal channel 109 can be lined with a mesh so as to form internal threads. The protrusions, grooves, or waves of thread 110 is at from about 1 to about 360 points per 360° (e.g., from about 1 to about 10, from about 10 to about 100, or from about 300 to about 360), in which 360 points per 360° points defines a full thread. Thread 110 is / are a non-continuous thread or can be a continuous thread. Thread 110 is / are broken by at least one opening, e.g., at least one slit or at least one hole. The non-continuous thread(s) include(s) a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, or from about 20 mm to about 30 mm). First plurality of openings 107 in central region 105 includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 50, from about 2 to about 100, or, e.g., about 50, or, e.g., about 4 helical slits), together encompassing from between about 20% to 80% (e.g., from about 20% to about 30%, from about 50% to about 80%, or, e.g., about 80%) of a total external surface area of central region 105. First plurality of openings 107 in central region 105 extend from one region into at least one other, e.g., an opening in central region 105 may extend into proximal region 104 and / or distal region 106. First plurality of openings 107 in central region 105 include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 1 mm to about 1 .5 mm, or, e.g., about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 10 mm to about 20 mm, from about 75 to about 100 mm, or from about 100 mm to 150 mm). First plurality of openings 107 in central region 105 can be holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 1 .5 mm to about 3 mm, or, e.g., about 2.4 mm). First plurality of openings 107 in central region 105 can be slits, in which the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 1 mm to about 1.5 mm, or, e.g., about 2.4 mm). First plurality of openings 107 in central region 105 may be slits, helical slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes. First plurality of openings107 in central region 105 may be configured to promote toroidal flow in a biomaterial injected into internal channel 109, such first plurality of openings 107 are helical slits. The helical slits are continuous along a length of the central region. The helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, about 40- 80 mm, or, e.g., about 100 mm). The helical slits have a number of turns per unit length of between 0.1 and 5 turns / cm (e.g., about 0.1 to 0.5 turns / cm, about 1 to 2 turns / cm, or about 4 to 5 turns / cm). First plurality of openings 107 in central region 105 can include 2-10 helical slits; preferably 4-6 helical slits. Second plurality of openings 108 in distal region 106 includes from 1 to 200 openings (e.g., from about 4 to about 10, from about 50 to about 200, or, e.g., 32 diamond-shaped openings), together encompassing between about 15% to about 80% (e.g., from about 15% to about 30, from about 30% to about 60%, or e.g., about 70%) of a total surface area of an external surface of distal region 106. Second plurality of openings 108 may have an internal perimeter that is round, square, diamond-shaped, triangular, an n- sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. Second plurality of openings 108 in distal region 106 may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 5, 10, 15, or 20), star-shaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. Second plurality of openings 108 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes. Second plurality of openings 108 in distal region 106 include staggered or straight openings. Second plurality of openings 108 in distal region 106 includes 2-10 helical slits; preferably 4-6 helical slits. Second plurality of openings 108 in distal region 106 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 1 mm to about 1 .5 mm, or, e.g., about 2.4 mm). Device 100 can be pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., pellets of biomaterial 414 of FIGs. 4I- 4K). The loading of the pellets of biomaterial in device 400 would be equivalent for device 100. The solid dose biomaterial can be a compressed powder (e.g., compressed at a pressure of 10 to 150 MPa) and can be a mixture of particles of a calcium phosphate (e.g., 65-85 wt%) and a phosphoserine or phosphocreatine (e.g., 15-35 wt%, such as 20-30 wt% or 22-27 wt%). The biomaterial may further include calcium silicate (e.g., in an amount of 0.2-2 wt%, e.g., 0.5-1 .5 wt%). The biomaterial can also have a density of about 1 .20-1 .80 g / cm3. First plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 may be sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of biomaterial (e.g., in the form of pellets). Distal end 103 can be blunt and / or tapered. Distal end 103 has at least one or a plurality of milling flutes, notches, and / or elongated tips. Distal end 103 includes at least one notch or from 2 to 4 notches (e.g., 3 notches), such as notches 111 in distal end 103. Distal end 103 can include at least one milling flute or 2 to 5 milling flutes (e.g., 3 milling flutes) which can have sharpened edges. Distal end 103 can be sized and tapered to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 103 of device 100. Proximal end 102 can include an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. The outer diameter from proximal end 102 to distal end 103 may be constant.
[0229] Device 400
[0230] With reference to FIGs. 4A-4M, device 400 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation. Device 400 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 400) and can be used as a compression screw component, fastener, or suture anchor. Device 400 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (e.g., sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., nail system of FIG. 3), a screw, a suture, a prosthesis, or other similar hardware, and as a spinal attachment device. Once inserted, device 400 can be used to uniformly deliver a biomaterial to the bone, secure the bone structure and / or soft tissue, and promote bone repair and / or soft tissue and / or healing. Advantageously, device 400 promotes improved (e.g., increased) distribution of a biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of a defect in the bone.
[0231] Device 400 has unitary body 401 that includes proximal end 402, distal end 403, proximal region 404 with thread 410 in the exterior of proximal region 404, distal region 406, and plurality of openings 412 in distal region 406 (see, e.g., FIGs. 4A-4M). Device 400 also include internal channel 409 (see, e.g., FIGs. 4E-4J) that extends longitudinally through unitary body 401 . Device 400 can include internal protrusion(s) (e.g., internal thread) 413 that is / are located within internal channel 409 (see, e.g., FIGs. 4I and 4J). Device 400 can include notches 411 . In some embodiments, device 400 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from about 160 to about 180 mm, or from about 175 to about 180 mm, from about
[0232] 10 mm to about 110 mm, from about 20 mm to about 110 mm, from about 25 mm to about 110 mm, from about 30 mm to about 110 mm, from about 35 mm to about 110 mm, from about 40 mm to about 110 m, from about 45 mm to about 110 mm, from about 50 mm to about 110 mm, from about 55 mm to about
[0233] 110 mm, from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 110 mm, from about 90 mm to about 110 mm, from about 95 mm to about 110 mm, from about 100 mm to about 110 mm, from about 105 mm to about 110 mm, about 9 mm, about 10 mm, about
[0234] 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 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, about 1 10 mm, about 111 mm, about 112 mm, about 1 13 mm, about 1 14 mm, about 115 mm, about 116 mm, about 1 17 mm, about 1 18 mm, about 119 mm, about 120 mm, about 121 mm, about 122 mm, about 123 mm, about 124 mm, about 125 mm, about 126 mm, about 127 mm, about 128 mm, about 129 mm, about 130 mm, about 131 mm, about 132 mm, about 133 mm, about 134 mm, about 135 mm, about 136 mm, about 137 mm, about 138 mm, about 139 mm, about 140 mm, about 141 mm, about 142 mm, about 143 mm, about 144 mm, about 145 mm, about 146 mm, about 147 mm, about 148 mm, about 149 mm, about 150 mm, about 151 mm, about 152 mm, about 153 mm, about 154 mm, about 155 mm, about 156 mm, about 157 mm, about 158 mm, about 159 mm, about 160 mm, about 161 mm, about 162 mm, about 163 mm, about 164 mm, about 165 mm, about 166 mm, about 167 mm, about 168 mm, about 169 mm, about 170 mm, about 171 mm, about 172 mm, about 173 mm, about 174 mm, about 175 mm, about 176 mm, about 177 mm, about 178 mm, about 179 mm, or about 180 mm). In some embodiments, device 400 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm). In some embodiments, device 400 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, 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).
[0235] The internal surface of device 400 may be smooth or textured (e.g., rough), e.g., including at least one internal protrusion 413. Internal channel 409 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 400.
[0236] In some embodiment, device 400 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200).
[0237] In some embodiments, device 400 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 400 can also be 3D printed using these materials or others.
[0238] In some embodiments, distal end 403 can be blunt and / or can be tapered. In some embodiments, distal end 403 has a blunt edge. In some embodiments, distal end 403 has a tapered edge. In some embodiments, distal end 403 has at least one or a plurality of milling flutes, notches, and / or elongated tips. In some embodiments, distal end 403 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 403 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 403 includes at least one notch. In some embodiments, distal end 403 has from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the opening at distal end 403 to internal channel 409 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of pellets of biomaterial 414 (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, tapered distal end 403 is sized to prevent the pre-loaded pellets of biomaterial 414 from exiting distal end 403 of device 400. In some embodiments, proximal end 402 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. In some embodiments, the outer diameter from proximal end 402 to distal end 403 is constant.
[0239] Proximal region of device 400
[0240] Device 400 includes proximal region 404 that includes internal channel 409 and thread 410 in the exterior of proximal region 404 (see, e.g., FIGs. 4A-4M). Proximal region 404 in device 400 can also include internal protrusion(s) 413 (e.g., forming an internal thread) that is / are located in internal channel 409 (see, e.g., FIGs. 4I and 4J). In some embodiments, proximal region 404 does not have openings other than the opening to internal channel 409 at proximal end 402.
[0241] In some embodiments, proximal region 404 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of proximal region 404 is smaller than, larger than, or equal to the outer diameter of distal region 406. In some embodiments, the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 proximal region 404 is smaller than, larger than, or equal to the inner diameter of distal region 406.
[0242] In some embodiments, proximal region 404 has a length of from about 2 mm to 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0243] In some embodiments, proximal region 404 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 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, 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 4.0 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of proximal region 404 is about 2.5 mm, in which, optionally, the wall thickness of proximal region 404 is about 4.5 mm. In certain embodiments, the wall thickness of proximal region 404 is smaller than, larger than, or equal to the wall thickness of distal region 406.
[0244] In some embodiments, internal protrusion(s) (e.g., internal thread) 413 located within internal channel 409 and / or thread 410 located on the exterior of proximal region 404 has / have a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 11 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm).
[0245] In some embodiments, internal protrusion(s) 413 (e.g., forming an internal thread) located within internal channel 409 and / or thread 410 located on the exterior of proximal region 404 is / are formed from protrusions, grooves, waves, or a mesh. In some embodiments, internal channel 409 is lined with a mesh so as to form internal threads. In some embodiments, the protrusions, grooves, or waves of internal protrusion(s) 413 (e.g., internal thread) and / or thread 410 is / are at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread. In some embodiments, internal protrusion(s) 413 (e.g., internal thread) and / or thread 410 is / are a continuous thread or non-continuous thread. In some embodiments, internal protrusion(s) 413 (e.g., internal thread) and / or thread 410 is / are broken by at least one opening, e.g., at least one slit or at least one hole. In some embodiments, the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
[0246] Distal region of device 400
[0247] Device 400 includes distal region 406 that includes plurality of openings 412 and internal channel 409. In some embodiments, distal region 406 does not have openings other than the opening to internal channel 409 at distal end 403.
[0248] In some embodiments, distal region 406 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of distal region 406 is smaller than, larger than, or equal to the outer diameter of proximal region 404. In some embodiments, distal region 406 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from 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 distal region 406 is smaller than, larger than, or equal to the inner diameter of proximal region 404.
[0249] In some embodiments, distal region 406 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0250] In some embodiments, distal region 406 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of distal region 406 is about 0.7 mm.
[0251] Distal region 406 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of distal region 406, e.g., the exterior of distal region 406, an interior of distal region 406, and / or interior walls of the openings of distal region 406.
[0252] Plurality of openings 412 of distal region 406 may have an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. Plurality of openings 412 in distal region 406 may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20), star-shaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. Plurality of openings 412 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes. In some embodiments, plurality of openings 412 in distal region 406 include staggered or straight openings. In some embodiments, plurality of openings 412 in distal region 406 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, plurality of openings 412 extend through an entire length of distal region 406. Plurality of openings 412 in distal region 406 can also contribute to reducing flow resistance in internal channel 409. Without wishing to be bound by theory, biomaterial in a fluidic state rotates around the center axis of internal channel 409, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation. The perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
[0253] In some embodiments, plurality of openings 412 in distal region 406 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings). In some embodiments, plurality of openings 412 in distal region 406 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 3 mm, about 4 mm, or about 5 mm).
[0254] In some embodiments, device 400 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., FIGs. 4I-4K). In some embodiments, plurality of openings 412 in distal region 406 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the pellets of biomaterial 414 (e.g., the solid dose biomaterial, e.g., in the form of pellets) (see, e.g., FIGs. 4I-4K). In some embodiments, the opening to internal channel 409 at distal end 403 has a cross-sectional dimension that is narrower than the cross-sectional dimension of the pellets of biomaterial 414. In some embodiments, tapered distal end 403 is sized to prevent the pre-loaded pellets of biomaterial 414 from exiting distal end 403 of device 400. In some embodiments, plurality of openings 412 in distal region 406 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of distal region 406.
[0255] With reference to FIGs. 4A-4M, device 400 has similar features to device 100 as described previously, including unitary body 401 that includes proximal end 402, distal end 403, proximal region 404, thread 410 in proximal region 404, distal region 406, plurality of openings 412 in distal region 406, and notches 411 . Device 400 also includes internal channel 409 that extends longitudinally through unitary body 401 and can additionally include internal protrusion(s) 413 (e.g., internal thread) (see, e.g., FIGs. 4H-4J and 4M). In contrast to device 100, device 400 does not include a central region and more than one plurality of openings (see, e.g., central region 105, first plurality of openings 107 in central region 105, and second plurality of openings 108 in distal region of FIGs. 1A-1 H and 2).
[0256] Device 500
[0257] With reference to FIG. 5 and, device 500 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation. Device 500 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 500) and can be used as a compression screw component, fastener, or suture anchor. Device 500 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (see, e.g., sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., nail system of FIG. 3), screw, a suture, a prosthesis, or other similar hardware, and a spinal attachment device. Once inserted, device 500 can be used to uniformly deliver a biomaterial to the bone, secure the bone and / or soft tissue structure, and promote bone and / or soft tissue repair and / or healing. Advantageously, device 500 promotes improved (e.g., increased) distribution of biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of the insertion site and / or a defect in the bone.
[0258] Device 500 has unitary body 501 that includes proximal end 502, distal end 504, proximal region 504, distal region 506, first plurality of openings 507 in proximal region 504, and second plurality of openings 508 in distal region 506 (see, e.g., FIG. 5). Device 500 also includes internal channel 509 that extends longitudinally through unitary body 501 . Device 500 can optionally include notches 511. In some embodiments, device 500 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from about 160 to about 180 mm, or from about 175 to about 180 mm, from about 10 mm to about 1 10 mm, from about 20 mm to about 110 mm, from about 25 mm to about 110 mm, from about 30 mm to about 110 mm, from about 35 mm to about 110 mm, from about 40 mm to about 110 mm, from about 45 mm to about 110 mm, from about 50 mm to about 110 mm, from about 55 mm to about 110 mm, from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 1 10 mm, from about 90 mm to about 110 mm, from about 95 mm to about 110 mm, from about 100 mm to about 1 10 mm, from about 105 mm to about 110 mm, about 9 mm, about 10 mm, about 1 1 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 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, about 1 10 mm, about 111 mm, about 1 12 mm, about 1 13 mm, about 114 mm, about 1 15 mm, about 1 16 mm, about 117 mm, about 118 mm, about 119 mm, about 120 mm, about 121 mm, about 122 mm, about 123 mm, about 124 mm, about 125 mm, about 126 mm, about 127 mm, about 128 mm, about 129 mm, about 130 mm, about 131 mm, about 132 mm, about 133 mm, about 134 mm, about 135 mm, about 136 mm, about 137 mm, about 138 mm, about 139 mm, about 140 mm, about 141 mm, about 142 mm, about 143 mm, about 144 mm, about 145 mm, about 146 mm, about 147 mm, about 148 mm, about 149 mm, about 150 mm, about 151 mm, about 152 mm, about 153 mm, about 154 mm, about 155 mm, about 156 mm, about 157 mm, about 158 mm, about 159 mm, about 160 mm, about 161 mm, about 162 mm, about 163 mm, about 164 mm, about 165 mm, about 166 mm, about 167 mm, about 168 mm, about 169 mm, about 170 mm, about 171 mm, about 172 mm, about 173 mm, about 174 mm, about 175 mm, about 176 mm, about 177 mm, about 178 mm, about 179 mm, or about 180 mm). In some embodiments, device 500 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 1 10 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm). In some embodiments, device 500 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, 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).
[0259] The internal surface of device 500 may be smooth or textured (e.g., rough). Internal channel 509 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 500.
[0260] In some embodiments, device 500 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200). In some embodiments, device 500 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 500 can also be 3D printed using these materials or others.
[0261] In some embodiments, distal end 503 can be blunt and / or can be tapered. In some embodiments, distal end 503 has a blunt edge. In some embodiments, distal end 503 has a tapered edge. In some embodiments, distal end 503 has at least one or a plurality of milling flutes, notches, and / or elongated tips. In some embodiments, distal end 503 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 503 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 503 includes at least one notch. In some embodiments, distal end 503 has from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the opening at distal end 503 to internal channel 509 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a solid dose of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, tapered distal end 503 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 503 of device 500. In some embodiments, proximal end 502 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. In some embodiments, the outer diameter from proximal end 502 to distal end 503 is constant.
[0262] Proximal region of device 500
[0263] Device 500 includes proximal region 504 that may not have openings other than the opening to internal channel 509 at proximal end 502. In some embodiments, proximal region 504 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of proximal region 504 is smaller than, larger than, or equal to the outer diameter of distal region 506. In some embodiments, the proximal region has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 proximal region 504 is smaller than, larger than, or equal to the inner diameter of distal region 506.
[0264] In some embodiments, proximal region 504 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0265] In some embodiments, proximal region 504 has a wall thickness of from about 0.6 mm to about 5.5 mm (e.g., about 0.8 mm to about 3.0 mm, about 1 .5 mm to about 2.8 mm, about 2.3 mm to about 2.7 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 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, 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 4.0 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of proximal region 504 is about 2.5 mm, in which, optionally, the wall thickness of proximal region 504 is about 4.5 mm. In certain embodiments, the wall thickness of proximal region 504 is smaller than, larger than, or equal to the wall thickness of distal region 506.
[0266] Proximal region 504 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on the exterior of proximal region 504.
[0267] In some embodiments, first plurality of openings 507 in proximal region 504 includes 1 to 100 openings (e.g., from about 1 to about 10, from about 2 to about 10, from about 3 to about 10, from about 4 to about 10, from about 5 to about 10, from about 6 to about 10, from about 2 to about 20, from about 2 to about 30, from about 2 to about 40, from about 2 to about 50, from about 2 to about 75, from about 2 to about 100, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20 openings, or, e.g., about 10, about 20, about 30, about 40, about 50, about 60, about 70, about 80, about 90, or about 100, or, e.g., about 4 helical slits).
[0268] In some embodiments, first plurality of openings 507 in proximal region 504 include a width of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm) and a length of from about 0.01 mm to about 150 mm (e.g., from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 45 mm to about 75 mm, from about 50 mm to about 80 mm, from about 100 to about 150 mm, from about 125 to about 150 mm, from about 130 to about 140 mm, from about 140 to about 150 mm, or from about 145 to about 150 mm).
[0269] In some embodiments, first plurality of openings 507 in proximal region 504 include holes, in which the holes include a circular or elliptical shape including a diameter of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
[0270] First plurality of openings 507 in proximal region 504 may be slits, helical slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, elliptical holes, triangular holes, polygonal holes, or amorphous holes. First plurality of openings 507 in proximal region 504 may be configured to promote toroidal flow in a biomaterial injected into internal channel 509, such first plurality of openings 507 are helical slits. First plurality of openings 507 in proximal region 504 may additionally induce toroidal flow in the volume of biomaterial as it flows out of first plurality of openings 507 and into the adjacent bone tissue. The toroidal flow can reduce flow resistance in the biomaterial during injection. In some embodiments, the slits have a width of from about 0.1 mm to about 5 mm (e.g., from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, or from about 1 .5 mm to about 2 mm, from about 1 .5 mm to about 3 mm, from about 2 mm to about 2.5 mm, from about 2.5 mm to about 4 mm, from about 3 to about 4.5 mm, from about 4 to about 5 mm, e.g., about 2 mm, e.g., about 1 .8 mm, about 2.3 mm, or about 2.4 mm).
[0271] In some embodiments, first plurality of openings 507 in proximal region 504 are helical slits. In some embodiments, the helical slits are continuous along a length of proximal region 504. In some embodiments, the helical slits have a pitch of between about 10 mm and 100 mm (e.g., a pitch of between about 10-20 mm, 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50-70 mm, about 75-100 mm, about 80-100 mm, about 80-90 mm, or about 90-100 mm, e.g., 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 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, e.g., 51 .5 mm). In some embodiments, the helical slits have a number of turns per unit length of between 0.1 and 5 turns / cm (e.g., from about 0.1 to 0.2 turns / cm, about 0.1 to 0.3 turns / cm, about 0.1 to 0.4 turns / cm, about 0.1 to 0.5 turns / cm, about 0.25 to 0.5 turns / cm, about 0.3 to 0.6 turns / cm, about 0.4 to 0.5 turns / cm, about 0.4 to 0.6 turns / cm, about 0.5 to 0.6 turns / cm, about 0.5 to 0.9 turns / cm, about 0.6 to 0.8 turns / cm, about 0.7 to 0.9 turns / cm, about 0.75 to 1 turns / cm, about 0.75 to 1 .5 turns / cm, about 0.1 to 1 turns / cm, about 1 .1 to 1 .2 turns / cm, about 1 to 2 turns / cm, about 1 to 1 .5 turns / cm, about 1 .3 to 1 .6 turns / cm, about 1 .4 to 1 .8 turns / cm, about 1 .5 to 2 turns / cm, about 1 .8 to 2.2 turns / cm, about 1 .5 to 2.5 turns / cm, about 2 to 2.5 turns / cm, about 2.2 to 2.8 turns / cm, about 2 to 3 turns / cm, about 2 to 4 turns / cm, about 3 to 4 turns / cm, about 2 to 5 turns / cm, about or about 4 to 5 turns / cm, e.g., about 0.1 turns / cm, about 0.2 turns / cm, about 0.3 turns / cm, about 0.4 turns / cm, about 0.5 turns / cm, about 0.6 turns / cm, about 0.7 turns / cm, about 0.8 turns / cm, about 0.9 turns / cm, about 1 .0 turns / cm, about 1 .1 turns / cm, about 1 .2 turns / cm, about 1 .3 turns / cm, about 1 .4 turns / cm, about 1 .5 turns / cm, about 1 .6 turns / cm, about 1 .7 turns / cm, about 1 .8 turns / cm, about 1 .9, about 2 turns / cm, about 2.1 turns / cm, about 2.2 turns / cm, about 2.3 turns / cm, about 2.4 turns / cm, about
[0272] 2.5 turns / cm, about 2.6 turns / cm, about 2.7 turns / cm, about 2.8 turns / cm, about 2.9, about 3 turns / cm, about 4.1 turns / cm, about 4.2 turns / cm, about 4.3 turns / cm, about 4.4 turns / cm, about 4.5 turns / cm, about
[0273] 4.6 turns / cm, about 4.7 turns / cm, about 4.8 turns / cm, about 4.9, about 5 turns / cm, e.g., 0.375 turns / cm). In some embodiments, first plurality of openings 507 in proximal region 504 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, device 500 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets. In this embodiment, first plurality of openings 507 in proximal region 504 may be sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., the solid dose biomaterial, e.g., in the form of pellets).
[0274] In some embodiments, first plurality of openings 507 in proximal region 504 together encompass from between about 20% to 80% (e.g., from about 20% to about 30%, from about 20% to about 65%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total external surface area of proximal region 504.
[0275] In some embodiments, first plurality of openings 507 in proximal region 504 extend through an entire length of proximal region 504. In some embodiments, first plurality of openings 507 in proximal region 504 extend from one region into at least one other, for example an opening in proximal region 504 may extend into distal region 506. Proximal region 504 may have different types of openings than distal region 506, e.g., first plurality of openings 507 in proximal region 504 may be helical openings (e.g., helical slits) that extend the full length of proximal region 504, while second plurality of openings 508 in distal region 506 are closed shaped voids that do not extend from proximal to distal end of distal region 506, e.g., second plurality of openings 508 that are holes dispersed along the length of distal region 506 (see, e.g., FIG. 5). Such a difference in openings in proximal region 504 and distal region 506 allows greater volumetric expansion of biomaterial between the proximal and distal region. Many bone defects are centrally located, and, thus, such a dispersion profile is advantageous for targeting the defect.
[0276] Distal region of device 500
[0277] Device 500 includes distal region 506 that includes second plurality of openings 508 and internal channel 509. In some embodiments, distal region 506 does not have openings other than the opening to internal channel 509 at distal end 503.
[0278] In some embodiments, distal region 506 has an outer diameter of from about 1 .25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In certain embodiments, the outer diameter of distal region 506 is smaller than, larger than, or equal to the outer diameter of proximal region 504. In some embodiments, distal region 506 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 2 mm to about 5 mm, from about 4 mm to about 8 mm, from about 5 mm to about 10 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from 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 distal region 506 is smaller than, larger than, or equal to the inner diameter of proximal region 504.
[0279] In some embodiments, distal region 506 has a length of from about 2 mm to about 100 mm (e.g., from about 2 mm to about 5 mm, from about 2 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from about 20 mm to about 30 mm, from about 25 to about 50 mm, from about 30 to about 40 mm, from about 40 to about 50 mm, from about 45 to about 60 mm, from about 50 to about 60 mm, from about 55 mm to about 65 mm, from about 60 mm to about 70 mm, from about 75 to about 100 mm, from about 70 mm to 80 mm, from about 80 mm to 90 mm, or from about 90 mm to 100 mm).
[0280] In some embodiments, distal region 506 has a wall thickness of from 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of distal region 506 is about 0.7 mm.
[0281] Distal region 506 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of distal region 506, e.g., the exterior of distal region 506, an interior of distal region 506, and / or interior walls of the openings of distal region 506.
[0282] Second plurality of openings 508 may have an internal perimeter that is round, square, diamondshaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. Second plurality of openings 508 in distal region 506 may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15, 16, 17, 18, 19, or 20), star-shaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. Second plurality of openings 508 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes. In some embodiments, second plurality of openings 508 in distal region 506 include staggered or straight openings. In some embodiments, second plurality of openings 508 in distal region 506 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, second plurality of openings 508 extend through an entire length of distal region 506. Second plurality of openings 508 in distal region 506 can also contribute to reducing flow resistance in internal channel 509 in combination with first plurality of openings 507 in proximal region 504. Without wishing to be bound by theory, biomaterial in a fluidic state rotates around the center axis of internal channel 509, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation. The perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
[0283] In some embodiments, second plurality of openings 508 in distal region 506 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings).
[0284] In some embodiments, second plurality of openings 508 in distal region 506 have a cross- sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 3 mm, about 4 mm, or about 5 mm).
[0285] In some embodiments, second plurality of openings 508 in distal region 506 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets). In some embodiments, the opening to internal channel 509 at distal end 503 has a cross-sectional dimension that is narrower than the cross- sectional dimension of the solid dose of the biomaterial. In some embodiments, tapered distal end 503 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 503 of device 500.
[0286] In some embodiments second plurality of openings 508 in distal region 506 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of distal region 506.
[0287] With reference to FIG. 5, device 500 has similar features to device 100 as described previously, including unitary body 501 that includes proximal end 502, distal end 503, proximal region 504, distal region 506, first plurality of openings 507, second plurality of openings 508 in distal region 506, and notches 511 . Device 500 also includes internal channel 509 that extends longitudinally through unitary body 501 and does not include internal protrusion(s) (e.g., internal thread) as device 400 does (see, e.g., internal protrusion(s) 413 of FIGs. 4H-4J and 4M). In contrast to device 100, device 500 does not include an external thread in proximal region 504 and does not include a central region (see, e.g., thread 110 in proximal region 104 and central region 105 of FIGs. 1A-1 H and 2). In contrast to device 100, device 500 includes first plurality of openings 507 that are located in proximal region 504 (see, e.g., FIG. 5) rather than in a central region (see, e.g., first plurality of openings 107 in central region 105 of FIGs. 1A-1 H and 2).
[0288] Device 600
[0289] With reference to FIGs. 6A-6I, device 600 of the disclosure is an implant that can be used for multiple purposes, including repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone, repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, or providing or improving implant fixation. Device 600 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 600) and can be used as a compression screw component, fastener, or suture anchor. Device 600 can be used in combination with, or to secure, other hardware, such as, e.g., a bone plate (e.g., sliding hip screw system of FIG. 7), a soft tissue suture anchor (see, e.g., the suture anchor system of FIG. 9), an intramedullary pin, a nail (see, e.g., nail system of FIG. 3), screw, a suture, a prosthesis, or other similar hardware, and a spinal attachment device. Once inserted, device 600 can be used to uniformly deliver a biomaterial to the bone, secure the bone and / or soft tissue structure, and promote bone and / or soft tissue repair and / or healing. Advantageously, device 600 promotes improved (e.g., increased) distribution of biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of the insertion site and / or a defect in the bone.
[0290] Device 600 has unitary body 601 that includes proximal end 602, distal end 603, central region 605, and plurality of openings 612 in central region 605 (see, e.g., FIGs. 6A-6I). Device 600 also includes internal channel 609 (see, e.g., FIGs. 6E-6I) that extends longitudinally through unitary body 601 . Device 600 can include internal protrusion(s) 613 (e.g., forming an internal thread) that is / are located within internal channel 609 (see, e.g., FIGs. 6G and 6I). Device 600 can include notches 611. In some embodiments, device 600 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from about 160 to about 180 mm, or from about 175 to about 180 mm, from about 10 mm to about 1 10 mm, from about 20 mm to about 110 mm, from about 25 mm to about 110 mm, from about 30 mm to about 110 mm, from about 35 mm to about 110 mm, from about 40 mm to about 110 mm, from about 45 mm to about 110 mm, from about 50 mm to about 110 mm, from about 55 mm to about 110 mm, from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 110 mm, from about 90 mm to about 110 mm, from about 95 mm to about 110 mm, from about 100 mm to about 110 mm, from about 105 mm to about 110 mm, about 9 mm, about 10 mm, about 1 1 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 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, about 1 10 mm, about 111 mm, about 1 12 mm, about 113 mm, about 114 mm, about 1 15 mm, about 116 mm, about 1 17 mm, about 118 mm, about 119 mm, about 120 mm, about 121 mm, about 122 mm, about 123 mm, about 124 mm, about 125 mm, about 126 mm, about 127 mm, about 128 mm, about 129 mm, about 130 mm, about 131 mm, about 132 mm, about 133 mm, about 134 mm, about 135 mm, about 136 mm, about 137 mm, about 138 mm, about 139 mm, about 140 mm, about 141 mm, about 142 mm, about 143 mm, about 144 mm, about 145 mm, about 146 mm, about 147 mm, about 148 mm, about 149 mm, about 150 mm, about 151 mm, about 152 mm, about 153 mm, about 154 mm, about 155 mm, about 156 mm, about 157 mm, about 158 mm, about 159 mm, about 160 mm, about 161 mm, about 162 mm, about 163 mm, about 164 mm, about 165 mm, about 166 mm, about 167 mm, about 168 mm, about 169 mm, about 170 mm, about 171 mm, about 172 mm, about 173 mm, about 174 mm, about 175 mm, about 176 mm, about 177 mm, about 178 mm, about 179 mm, or about 180 mm). In some embodiments, device 600 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 1 10 mm, greater than 120 mm, or greater than 130 mm , or greater than 140 mm). In some embodiments, device 600 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, 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).
[0291] The internal surface of device 600 may be smooth or textured (i.e., rough), e.g., including at least one internal protrusion 613. Internal channel 609 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 600.
[0292] In some embodiments, device 600 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200).
[0293] In some embodiments, device 600 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 600 can also be 3D printed using these materials or others.
[0294] In some embodiments, distal end 603 can be blunt and / or can be tapered. In some embodiments, distal end 603 has a blunt edge. In some embodiments, distal end 603 has a tapered edge. In some embodiments, distal end 603 has at least one or a plurality of milling flutes, notches, and / or elongated tips. In some embodiments, distal end 603 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 603 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 603 includes at least one notch. In some embodiments, distal end 603 has from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the opening at distal end 603 to internal channel 609 may be sized to have a cross-sectional dimension narrower than the cross-sectional dimension of a pellet of biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, tapered distal end 603 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 603 of device 600. In some embodiments, proximal end 602 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. In some embodiments, the outer diameter from proximal end 602 to distal end 603 is constant. Central region of device 600
[0295] Device 600 includes central region 605 that includes plurality of openings 612 and internal channel 609 (see, e.g., FIGs. 6E-6I). Central region 605 in device 600 can also include internal protrusion(s) 613 (e.g., as an internal thread) that is / are located in internal channel 609 (see, e.g., FIGs. 6G and 6I). In some embodiments, central region 605 does not have openings other than the opening to internal channel 609 at proximal end 602.
[0296] In some embodiments, central region 605 has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In some embodiments, central region 605 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 1 1 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).
[0297] In some embodiments, central region 605 has a length from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about 10-20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50- 150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160-180 mm, about 175-190 mm, about 175-200 mm, about 180- 200 mm, or about 190-200 mm, e.g., about 10 mm, about 20 mm, about 25 mm, about 50 mm, about 75, about 90 mm, about 100 mm, about 125 mm, about 150 mm, about 175 mm, or about 200 mm).
[0298] In some embodiments, central region 605 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of central region 605 is about 0.7 mm. Central region 605 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of central region 605, e.g., the exterior of central region 605, an interior of central region 605, and / or interior walls of the openings of central region 605.
[0299] Plurality of openings 612 in central region 605 may have an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. Plurality of openings 612 in central region 605 may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20), star-shaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. Plurality of openings 612 in central region 605 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes. In some embodiments, plurality of openings 612 in central region 605 include staggered or straight openings. In some embodiments, plurality of openings 612 in central region 605 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, plurality of openings 612 extend through an entire length of central region 605. Plurality of openings 612 in central region 605 can also contribute to reducing flow resistance in internal channel 609. Without wishing to be bound by theory, biomaterial in a fluidic state rotates around the center axis of internal channel 609, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation. The perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
[0300] In some embodiments, plurality of openings 612 in central region 605 includes from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings). In some embodiments, plurality of openings 612 in central region 605 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 3 mm, about 4 mm, or about 5 mm).
[0301] In some embodiments, device 600 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., pellets of biomaterial 814 of FIG. 8B). The loading of the pellets of biomaterial in device 800 would be equivalent for device 100. In some embodiments, plurality of openings 612 in central region 605 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of the solid dose of the biomaterial (e.g., in the form of pellets). In some embodiments, the opening to internal channel 609 at distal end 603 has a cross-sectional dimension that is narrower than the cross-sectional dimension of the solid dose of the biomaterial. In some embodiments, tapered distal end 603 is sized to prevent the pre-loaded pellets of solid dose biomaterial from exiting distal end 603 of device 600.
[0302] In some embodiments plurality of openings 612 in central region 605 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of central region 605.
[0303] In some embodiments, internal protrusion(s) 613 (e.g., internal thread) located within internal channel 609 has a thread pitch of from about 0.25 mm to about 15 mm (e.g., from about 0.25 mm to about 0.5 mm, from about 0.5 mm to about 1 mm, from about 0.5 mm to about 1 .5 mm, from about 1 mm to about 2 mm, from about 1 mm to about 2.5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2.5 mm, from about 2.25 mm to about 3 mm, from about 2.5 mm to about 5 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 2.5 mm to about 7.5 mm, from about 5 mm to about 10 mm, from about 4.5 mm to about 9 mm, from about 6 mm to about 12 mm, from about 4 mm to about 8 mm, from about 7.5 mm to about 10.5 mm, from about 7.5 mm to about 12.5 mm, from about 7.5 mm to about 15 mm, from about 8 mm to about 12 mm, from about 10 mm to about 15 mm, from about 9 mm to about 14 mm, from about 10 mm to about 12.5 mm, from about 12 mm to about 14 mm, from about 11 mm to about 13 mm, from about 12 mm to about 15 mm, from about 12.5 mm to about 15 mm, from about 13 mm to about 14.5 mm, from about 14 mm to about 15 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, about 2.5 mm, about 2.6 mm, about 2.7 mm, about 2.8 mm, about 2.9 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 7 mm, about 7.5 mm, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, about 11 .5 mm, about 12 mm, about 12.5 mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, or about 15 mm).
[0304] In some embodiments, internal protrusion(s) 613 (e.g., internal thread) located within internal channel 609 is formed from protrusions, grooves, waves, or a mesh. In some embodiments, internal channel 609 is lined with a mesh so as to form internal threads. In some embodiments, the protrusions, grooves, or waves of internal protrusion(s) 613 (e.g., internal thread) is at from about 1 to about 360 points per 360° (e.g., from about 1 to about 4, from about 1 to about 6, from about 1 to about 8, from about 1 to about 10, from about 2 to about 4, from about 2 to about 6, from about 2 to about 10, from about 4 to about 10, from about 10 to about 20, from about 10 to about 50, from about 10 to about 100, from about 40 to about 60, from about 50 to about 100, from about 90 to about 180, from about 100 to about 200, from about 200 to about 300, or from about 300 to about 360), in which 360 points per 360° points defines a full thread. In some embodiments, internal protrusion(s) 613 (e.g., internal thread) is a continuous thread or non-continuous thread. In some embodiments, internal protrusion(s) 613 (e.g., internal thread) is broken by at least one opening, e.g., at least one slit or at least one hole. In some embodiments, the non-continuous thread includes a gap, in which the gap has a length from about 0.5 mm to about 30 mm (e.g., from about 0.5 mm to about 1 mm, from about 1 mm to about 2 mm, from about 2 mm to about 4 mm, from about 5 mm to about 10 mm, from about 10 mm to about 20 mm, or from about 20 mm to about 30 mm).
[0305] With reference to FIGs. 6A-6I, device 600 has similar features to device 100 as described previously, including unitary body 601 that includes proximal end 602, distal end 603, central region 605, plurality of openings 612, and notches 611. Device 600 also includes internal channel 609 that extends longitudinally through unitary body 601 (see, e.g., FIGs. 6E-6H). In contrast to device 100, device 600 includes internal protrusion(s) 613 (e.g., internal thread) that is / are located within internal channel 609 (see, e.g., FIGs. 6G and 6I). In further contrast to device 100, device 600 does not include more than one type of a plurality of openings, nor does it have a proximal region, a distal region, and an external thread (see, e.g., first plurality of openings 107 in central region 105, second plurality of openings 108 in distal region 106, proximal region 104, distal region 106, and thread 110 in proximal region 104 of FIGs. 1A-1 H and 2). Instead, device 600 includes only one type of a plurality of openings 612 and only a central region 605.
[0306] Device 800
[0307] With reference to FIGs. 8A-8D and FIG. 9, device 800 of the disclosure is an implant that can be used for multiple purposes, including repairing soft tissue (e.g., rotator cuff repair, acromioclavicular joint reconstruction, bicep tenodesis, or other surgical repairment procedures targeted to a ligament, a meniscus, a muscle, a tendon, etc.), supporting soft tissue repair, repairing a bone defect (e.g., a bone fracture, a bone cancer, osteoporosis, a metabolic bone disease, a stress fracture, scoliosis), stabilizing bone or providing or improving implant fixation. Device 800 is configured for insertion into bone (e.g., into a bone hole that is predrilled in the bone prior to insertion of device 800) and can be used as a screw anchor and / or a fastener. Device 800 can be used in combination with, or to secure, other hardware, such as, e.g., a suture, a prosthesis or other similar hardware. Once inserted, device 800 can be used to uniformly deliver a biomaterial to the bone, secure the soft tissue to the bone, and promote soft tissue repair and / or healing. Advantageously, device 800 promotes improved (e.g., increased) distribution of a biomaterial in central portions of the bone, e.g., to maximize biomaterial distribution at the locality of an insertion site in the bone.
[0308] Device 800 has unitary body 801 that includes proximal end 802, distal end 803, central region 805, and plurality of openings 812 in central region 805 (see, e.g., FIGs. 8A-8D). Device 800 also includes internal channel 809 (see, e.g., FIG. 8B) that extends longitudinally through unitary body 801 . In some embodiments, device 800 has a length of from about 9 mm to about 200 mm (e.g., from about 10 mm to about 180 mm, from about 10 to about 150 mm, from about 10 to about 20 mm, from about 10 to about 50 mm, from about 10 to about 25 mm, from about 10 to about 100 mm, from about 15 to about 25 mm, from about 20 to about 50 mm, from about 25 to about 50 mm, from about 30 to about 60 mm, from about 50 to about 100 mm, from about 40 to about 80 mm, from about 50 to about 150 mm, from about 75 to about 100 mm, from about 75 to about 150 mm, from about 80 to about 120 mm, from about 80 to about 160 mm, from about 75 to about 125 mm, from about 90 to about 100 mm, from about 90 to about 180 mm, from about 100 to about 150 mm, from about 120 to about 160 mm, from about 125 to about 175 mm, from about 140 to about 160 mm, from about 150 to about 180 mm, from about 160 to about 180 mm, or from about 175 to about 180 mm, from about 10 mm to about 110 mm, from about 20 mm to about 110 mm, from about 25 mm to about 110 mm, from about 30 mm to about 1 10 mm, from about 35 mm to about 110 mm, from about 40 mm to about 110 m, from about 45 mm to about 1 10 mm, from about 50 mm to about 1 10 mm, from about 55 mm to about 110 mm, from about 60 mm to about 110 mm, from about 65 mm to about 110 mm, from about 70 mm to about 110 mm, from about 75 mm to about 110 mm, from about 80 mm to about 110 mm, from about 85 mm to about 1 10 mm, from about 90 mm to about 110 mm, from about 95 mm to about 110 mm, from about 100 mm to about 1 10 mm, from about 105 mm to about 110 mm, about 9 mm, about 10 mm, about 1 1 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 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, about 1 10 mm, about 111 mm, about 1 12 mm, about 1 13 mm, about 114 mm, about 1 15 mm, about 1 16 mm, about 117 mm, about 118 mm, about 119 mm, about 120 mm, about 121 mm, about 122 mm, about 123 mm, about 124 mm, about 125 mm, about 126 mm, about 127 mm, about 128 mm, about 129 mm, about 130 mm, about 131 mm, about 132 mm, about 133 mm, about 134 mm, about 135 mm, about 136 mm, about 137 mm, about 138 mm, about 139 mm, about 140 mm, about 141 mm, about 142 mm, about 143 mm, about 144 mm, about 145 mm, about 146 mm, about 147 mm, about 148 mm, about 149 mm, about 150 mm, about 151 mm, about 152 mm, about 153 mm, about 154 mm, about 155 mm, about 156 mm, about 157 mm, about 158 mm, about 159 mm, about 160 mm, about 161 mm, about 162 mm, about 163 mm, about 164 mm, about 165 mm, about 166 mm, about 167 mm, about 168 mm, about 169 mm, about 170 mm, about 171 mm, about 172 mm, about 173 mm, about 174 mm, about 175 mm, about 176 mm, about 177 mm, about 178 mm, about 179 mm, or about 180 mm). In some embodiments, device 800 has a length greater than 9 mm (e.g., greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, greater than 80 mm, greater than 90, greater than 100 mm, or greater than 110 mm, greater than 120 mm, or greater than 130 mm, or greater than 140 mm). In some embodiments, device 800 has a length less than 200 mm (e.g., less than 190 mm, less than 180 mm, less than 170 mm, less than 160 mm, less than 150 mm, less than 140 mm, less than 130 mm, less than 120 mm, less than 110 mm, 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).
[0309] The internal surface of device 800 may be smooth or textured (e.g., rough), e.g., including at least one internal protrusion. Internal channel 809 may be straight, curved, radial, or helical, depending on the implantable device to be used with device 800.
[0310] In some embodiment, device 800 includes from about 1 to about 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200).
[0311] In some embodiments, device 800 is made from or includes a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof. Device 800 can also be 3D printed using these materials or others.
[0312] In some embodiments, distal end 803 can be blunt and / or can be tapered. In some embodiments, distal end 803 has a blunt edge. In some embodiments, distal end 803 has a tapered edge. In some embodiments, distal end 803 has at least one or a plurality of milling flutes, notches, and / or elongated tips. In some embodiments, distal end 803 includes at least one milling flute. In some embodiments, the milling flutes have sharpened edges. In some embodiments, distal end 803 has 2 to 5 milling flutes (e.g., from 2 to 4, 2, 3, 4, or 5 milling flutes). In some embodiments, distal end 803 includes at least one notch. In some embodiments, distal end 803 has from 2 to 4 notches (e.g., 2, 3, or 4 notches). In some embodiments, the distal end does not include an opening to internal channel 809. In some embodiments, the opening at distal end 803 to internal channel 809 may be sized to have a cross- sectional dimension narrower than the cross-sectional dimension of pellets of biomaterial 814 (e.g., a solid biomaterial, such as a solid dose biomaterial, e.g., in the form of pellets). In some embodiments, tapered distal end 803 is sized to prevent the pre-loaded pellets of biomaterial 814 from exiting distal end 803 of device 800. In some embodiments, proximal end 802 includes an interface for engagement with standard surgical instruments (e.g., for implantation and explanation). The standard surgical instruments may include, e.g., a standard Torx or hex driver. In some embodiments, the outer diameter from proximal end 802 to distal end 803 is constant.
[0313] Central region of device 800
[0314] Device 800 includes central region 805 that includes plurality of openings 812 and internal channel 809.
[0315] In some embodiments, central region 805 has an outer diameter of from about 1.25 mm to about 25 mm (e.g., from about 1 .25 mm to about 2 mm, from about 1 .25 mm to about 3 mm, from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 4 mm to about 8 mm, from about 4 mm to about 10 mm, from about 4 mm to about 15 mm, from about 4 to about 25 mm, from about 5 mm to about 10 mm, from about 10 mm to about 15 mm, from about 10 mm to about 20 mm, from about 15 mm to about 25 mm, from 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). In some embodiments, central region 805 has an inner diameter of from about 1 mm to about 20 mm (e.g., from about 1 mm to about 2 mm, from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 1 mm to about 5 mm, from about 1 mm to about 10 mm, from about 5 mm to about 10 mm, from about 5 mm to about 15 mm, from about 10 mm to about 15 mm, from about 15 mm to about 20 mm, from 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 1 1 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).
[0316] In some embodiments, central region 805 has a length of from about 5 mm to 200 mm (e.g., from about 10 mm to about 200 mm, e.g., about 5-100 mm, about 5-10 mm, about 5-20 mm, about 5-50 mm, about 10-150 mm, e.g., about 10-20 mm, about 10-50 mm, 10-25 mm, about 10-100 mm, about 15-25 mm, about 20-50 mm, about 25-50 mm, about 30-60 mm, about 50-100 mm, about 40-80 mm, about 50- 150 mm, about 75-100 mm, about 75-150 mm, about 80-120 mm, about 80-160 mm, about 75-125 mm, about 90-100 mm, about 90-180 mm, about 100-150 mm, about 120-160 mm, about 125-175 mm, about 140-160 mm, about 150-180 mm, about 160-180 mm, about 175-190 mm, about 175-200 mm, about 180- 200 mm, or about 190-200 mm, e.g., about 10 mm, about 20 mm, about 25 mm, about 50 mm, about 75, about 90 mm, about 100 mm, about 125 mm, about 150 mm, about 175 mm, or about 200 mm).
[0317] In some embodiments, central region 805 has a wall thickness of from about 0.2 mm to about 5.5 mm (e.g., about 0.2 to about 2.0 mm, about 1 .0 to about 2.0 mm, about 0.2 mm to 0.80 mm, about 1 .0 mm to about 5.0 mm, about 2.0 mm to about 5.5 mm, about 0.6 mm to about 5.0 mm, about 4.0 mm to about 5.0 mm, about 4.4 mm to about 4.6 mm, or about 3.0 mm to about 5.5 mm, e.g., 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 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 4.1 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 5.1 mm, about 5.2 mm, about 5.3 mm, about 5.4 mm, or about 5.5 mm) in which, optionally, the wall thickness of central region 805 is about 0.7 mm.
[0318] Central region 805 may include a textured surface, e.g., having a roughness of between 1 and 5 microns (e.g., between 3 and 4 microns, e.g., about 3.5 microns, e.g., 3.6 microns), for improved biomaterial interaction and fixation. The textured surface may be on any or all surfaces of central region 805, e.g., the exterior of central region 805, an interior of central region 805, and / or interior walls of the openings of central region 805.
[0319] Plurality of openings 812 may have an internal perimeter that is round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20, star-shaped, or a combination thereof. Plurality of openings 812 in central region 805 may be any shape that can be made in the material of the body, e.g., by additive or subtractive manufacturing techniques (e.g., 3D printing), such shapes may have internal perimeter that is, e.g., round, square, diamond-shaped, triangular, an n-sided regular or irregular polygon where n = 5-20 (e.g., where n is 6, 7, 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17, 18, 19, or 20), starshaped, a closed plane curve (e.g., circle, oval, ellipse, etc.), or a combination thereof. Plurality of openings 812 may include slits, segmented slits, longitudinal slits, circumferential slits, holes, circular holes, oval holes, elliptical holes, triangular holes, curvilinear holes, diamond-shaped holes, or polygonal holes. In some embodiments, plurality of openings 812 in central region 805 include staggered or straight openings. In some embodiments, plurality of openings 812 in central region 805 includes 2-10 helical slits; preferably 4-6 helical slits. In some embodiments, plurality of openings 812 extend through an entire length of central region 805. Plurality of openings 812 in central region 805 can also contribute to reducing flow resistance in internal channel 809. Without wishing to be bound by theory, biomaterial in a fluidic state rotates around the center axis of internal channel 809, so less friction in the center of biomaterial mass and friction of material at inner wall would restrict intrusion through the cannulation. The perforations allow a decrease in resistance as material exits lateral walls and creates a rotation force to facilitate progress of the biomaterial along the longitudinal flow axis.
[0320] In some embodiments, plurality of openings 812 in central region 805 include from 1 to 200 openings (e.g., from about 1 to about 25, from about 1 to about 50, from about 1 to about 75, from about 1 to about 100, from about 1 to about 125, from about 1 to about 150, from about 1 to about 175, from about 10 to about 50, from about 10 to about 100, from about 50 to about 100, from about 50 to about 200, from about 150 to about 200, from about 100 to about 200, about 1 , 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, or about 200 openings, or, e.g., 32 diamond-shaped openings).
[0321] In some embodiments, plurality of openings 812 in central region 805 have a cross-sectional dimension (e.g., a diameter) of from about 0.01 mm to about 5 mm (e.g., from about 0.01 mm to about 0.1 mm, from about 0.01 mm to about 0.3 mm, from about 0.01 mm to about 0.5 mm, from about 0.1 mm to about 0.5 mm, from about 0.1 mm to about 1 mm, from about 0.5 mm to about 1 mm, from about 1 mm to about 1 .5 mm, from about 1 mm to about 5 mm, from about 1 .5 mm to about 2 mm, from about 2 mm to about 5 mm, about 0.01 mm, about 0.05 mm, about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about 0.5 mm, about 0.55 mm, about 0.6 mm, about 0.65 mm, about 0.7 mm, about 0.75 mm, about 0.8 mm, about 0.85 mm, about 0.9 mm, about 0.95 mm, about 1 mm, about 2 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, about 3 mm, about 4 mm, or about 5 mm).
[0322] In some embodiments, device 800 is pre-loaded with a biomaterial (e.g., a solid biomaterial, such as a solid dose biomaterial) that may be in the form of pellets (see, e.g., pellets of biomaterial 814 of FIG. 8B). The loading of the pellets of biomaterial in device 800 is equivalent to device 400 (see, e.g., pellets of biomaterial 414 of FIGs. 4I-4K). In some embodiments, plurality of openings 812 in central region 805 are sized to have a cross-sectional dimension (e.g., width) that is narrower than a cross-sectional dimension (e.g., diameter) of pellets of biomaterial 814 (e.g., the solid dose biomaterial, e.g., in the form of pellets). In some embodiments, the opening to internal channel 809 at distal end 803 has a cross- sectional dimension that is narrower than the cross-sectional dimension of pellets of biomaterial 814. In some embodiments, tapered distal end 803 is sized to prevent the pre-loaded pellets of biomaterial 814 from exiting distal end 803 of device 800.
[0323] In some embodiments, plurality of openings 812 in central region 805 together encompass between about 15% to about 80% (e.g., from about 15% to about 30%, from about 15% to about 65%, from about 20% to about 30%, from about 25% to about 50%, from about 30% to about 45%, from about 20% to about 40%, from about 20% to about 70%, from about 30% to about 60%, from about 40% to about 60%, from about 50% to about 70%, from about 50% to about 80%, or from about 70% to about 80%, e.g., about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, or about 80%) of a total surface area of an external or an internal surface of central region 805.
[0324] With reference to FIGs. 8A-8D, device 800 has similar features to device 100 as described previously, including unitary body 801 that includes proximal end 802, distal end 803, central region 805, and plurality of openings 812. Device 800 also includes internal channel 809 that extends longitudinally through unitary body 801 (see, e.g., FIG. 8B). Device 800 does not include internal protrusion(s) (e.g., internal thread) that is / are located within internal channel 809 as device 400 does (see, e.g., internal protrusion(s) 413 of FIGs. 4H-4J and 4M). In contrast to device 100, device 800 does not include more than one plurality of openings, a proximal region, a distal region, an external thread, and notches at the distal end (see, e.g., first plurality of openings 107 in central region 105, second plurality of openings in distal region 106, proximal region 104, distal region 106, thread 110 in proximal region 104, and notches 111 of FIGs. 1 A-1 H and 2). Rather than notches, device 800 includes a tapered distal end that may include an opening to internal channel 809 that has a cross-sectional dimension narrower than the cross- sectional dimension of pellets of biomaterials 814. In some embodiments, device 800 has a shorter length than device 400 (see, e.g., FIG. 8D).
[0325] System for treating bone defects
[0326] Systems of the disclosure include a device of the disclosure (e.g., device 100, device 400, device 500, device 600, and / or device 800) and one or more additional implants with which the device engages to reinforce the bone (e.g., at a defect site, e.g., a fracture, osteoporosis, etc.). Examples of implants include nails (e.g., intramedullary nails, e.g., a cephalomedullary nails) and bone plates (e.g., extramedullary plate). Systems may include multiple devices of the disclosure.
[0327] Long Bones
[0328] The disclosure features a system that is particularly advantageous for reinforcing a long bone (e.g., a proximal femur, distal femur, a periarticular sacroiliac region, or a proximal humerus) of a subject (e.g., a subject with a defect in the bone, e.g., in the proximal femur, e.g., an intertrochanteric fracture, osteoporosis, etc.). The system includes a device as described herein (e.g., device 100, device 400, device 500, or device 600), which can be configured as a compression screw component, a lag screw, and a nail, e.g., as shown in FIG. 3. The three components together integrate as a compression assembly to reinforce the bone (e.g., the femur). The nail is an intramedullary nail (e.g., a cephalomedullary nail), configured to be inserted into the medullary cavity of the femur. A proximal portion of the nail includes two adjacent holes into which the device of the disclosure and the lag screw can be inserted, such that, when inserted, the screws align substantially along a centerline of, e.g., the femoral head and neck. The device acts as a compression screw component in concert with the lag screw to stabilize the nail and the proximal femur. The lag screw and compression screw component engage with each other to form a compression assembly in conjunction with the nail to reinforce the proximal femur of the subject. To describe the device of the disclosure as a compression screw component in this section, device 100 is discussed, but device 400, device 500, and device 600 may also be similarly used. Device 400, device 500, and device 600 include structurally and operationally similar components in comparison to device 100, as previously discussed (see the Detailed Description). Device 100 for use as a compression screw component is shown in FIGs. 1A-1 H and 2. Device 400 for use as a compression screw component is shown in FIGs. 4A-4M. Device 500 for use as a compression screw component is shown in FIG. 5. Device 600 for use as a compression screw component is shown in FIGs. 6A-6I. FIG. 3 highlights a key advantage over existing systems using device 100 for demonstration purposes; first plurality of openings 107 in central region 105 and second plurality of openings 108 in distal region 106 allow biomaterial to be delivered to bone tissue around the implant, providing additional reinforcement, and the possibility for other therapeutic remediation (e.g., promoting growth of new bone tissue). First plurality of openings 107 (e.g., helical slits) create a rotational force that facilitates flow of the biomaterial along the center, longitudinal axis of internal channel 109, while, together with second plurality of openings 108 (e.g., diamond shaped openings), also decreasing resistance in the biomaterial as it exits. Rotation of the biomaterial in the center of internal channel 109 also results in less friction at the wall of internal channel 109, preventing restriction of the flow of the biomaterial. The combination of openings for biomaterial delivery and stiffness affords synergistic improvement over existing systems. For example, increased stability and resistance to collapse and deformity. In addition, the lack of expansion or compression affords a cleaner extraction. For example, a ...
Claims
AMENDED CLAIMS received by the International Bureau on 05 November 2025 (05.11.2025)1 . A device comprising a unitary body comprising from a proximal end to a distal end: a proximal region, a central region, and a distal region, wherein: a) the device comprises an internal channel extending longitudinally through the unitary body and wherein the internal channel comprises an internal thread through at least one of the proximal, central, or distal regions; b) the proximal region comprises an external thread; c) the central region comprises a plurality of openings, wherein the plurality of openings of the central region is a plurality of helical openings; d) the distal region comprises a plurality of openings, wherein the plurality of openings of the distal region is a plurality of diamond-shaped openings; and e) the proximal region, central region, and distal region are stiff.
2. The device of claim 1 , wherein: a) the proximal region comprises an inner diameter of from about 3 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; b) the central region comprises an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 1 .25 mm to about 25 mm; c) the distal region comprises an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 4 mm to about 25 mm; or d) wherein the proximal region, the central region, and the distal region comprise an inner diameter of from 1 mm to about 20 mm and an outer diameter of from about 1 .25 mm to about 25 mm.
3. The device of claim 1 or claim 2, wherein the outer diameter from the proximal end to the distal end is constant.
4. The device of claim 1 or claim 2, wherein the outer diameter of the proximal region is greater than the outer diameters of the central region and the distal region.
5. The device of any one of claims 1 -4, comprising a length of from about 9 mm to about 200 mm.
6. The device of any one of claims 1 -5, wherein the proximal region comprises a length of from about 2 mm to about 100 mm.
7. The device of any one of claims 1 -6, wherein the central region comprises a length of from about 5 mm to about 150 mm.
8. The device of any one of claims 1 -7, wherein the distal region comprises a length of from about 2 mm to 100 mm.
9. The device of any one of claims 1 -8, wherein the proximal region comprises a wall thickness of from about 0.6 mm to about 5.5 mm, wherein optionally the wall thickness of the proximal region is about 2.5 mm.
10. The device of any one of claims 1-9, wherein the central region comprises a wall thickness of from about 0.2 mm to about 5.5 mm, wherein optionally the wall thickness of the distal region is about 0.7 mm.11 . The device of any one of claims 1-10, wherein the distal region comprises a wall thickness of from about 0.2 mm to about 5.5 mm, wherein optionally the wall thickness of the distal region is about 0.7 mm.
12. The device of any one of claims 1-11 , wherein the wall thickness of the central region is the same as the wall thickness of the distal region.
13. The device of any one of claims 1-12, wherein the plurality of openings is configured to disperse a fluid form of a biomaterial through the internal channel and to an area surrounding the unitary body.
14. Cancelled.
15. The device of any one of claims 1-13, wherein the plurality of helical openings are continuous openings spanning the central region from a proximal end to a distal end of the central region.
16. The device of claim 15, wherein the plurality of helical openings have a pitch of between 10 mm and 100 mm.
17. The device of claim 15 or claim 16, wherein the plurality of helical openings have a number of turns per unit length of between 0.1 turns / cm and 5 turns / cm.
18. The device of any one of claims 15-17, wherein the plurality of helical openings comprises from 2 to 10 helical openings, wherein optionally the plurality of helical openings comprises from 4 to 6 helical openings.
19. The device of any one of claims 15-18, wherein the helical openings comprise helical slits.
20. The device of claim 19, wherein the helical slits are configured to induce toroidal flow in the fluid form of the biomaterial through the internal channel and to the area surrounding the unitary body.
21. Cancelled.
22. Cancelled.
23. The device of any one of claims 1-13, wherein the plurality of diamond-shaped openings are dispersed along a length of the distal region from a proximal end to a distal end of the distal region.
24. Cancelled.
25. Cancelled.
26. The device of any one of claims 1-13, 15-20, and 23, wherein the plurality of openings comprise a width of from about 0.01 mm to about 5 mm and a length of from about 0.01 mm to about 150 mm.
27. The device of any one of claims 1-13, 15-20, 23, and 26, wherein the plurality of openings together comprises from between 15% to 80% of a total external surface area of the central region and distal region.
28. Cancelled.
29. Cancelled.
30. Cancelled.31 . The device of any one of claims 1-13, 15-20, 23, 26, and 27, wherein the plurality of openings comprises 1 to 100 openings comprising a width of from about 0.1 mm to about 5 mm and a length of from about 0.1 mm to about 150 mm or a cross-sectional dimension of about 0.1 mm to about 5 mm.
32. The device of any one of claims 1-13, 15-20, 23, 26-27, and 31 , wherein the plurality of openings comprises from 1 to 200 openings comprising a cross-sectional dimension of from about 0.01 mm to about 5 mm.
33. The device of any one of claims 1-13, 15-20, 23, 26-27, and 31 -32, wherein the plurality of openings together comprises from between 20% to 80% of a total external surface area of the central region.
34. The device of any one of claims 1-13, 15-20, 23, 26-27, and 31 -33, wherein the plurality of openings together comprises from between 15% to 80% of a total external surface area of the distal region.
35. The device of any one of claims 1-13, 15-20, 23, 26-27, and 31 -34, wherein the external thread of the proximal region is configured to engage with a locking screw.
36. Cancelled.
37. Cancelled.
38. Cancelled.
39. The device of claim 35, wherein the internal thread and / or external thread comprises a thread pitch of from about 0.25 mm to about 15 mm.
40. The device of claim 35 or claim 39, wherein the internal thread and / or external thread is formed from a plurality of protrusions, a plurality of grooves, a plurality of waves, or a mesh.41 . The device of claim 40, wherein the plurality of protrusions, the plurality of grooves, or the plurality of waves are at from about 1 to 360 points per 360°.
42. The device of claims 35 and 39-41 , wherein the internal and / or external thread comprises a continuous thread or a non-continuous thread.
43. The device of claim 42, wherein the non-continuous thread comprises a gap, wherein optionally the gap has a length from about 0.5 mm to about 30 mm.
44. The device of claims 40-43, wherein the internal and / or external thread is broken by the plurality of openings.
45. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-44 wherein the unitary body comprises a textured surface along at least one of the proximal, central, and distal regions.
46. The device of claim 45, wherein the textured surface has a roughness of between Ra = about 1 micron to Ra = about 5 microns.
47. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-46, wherein the distal end comprises a blunt and / or tapered edge.
48. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-47, wherein the distal end comprises from 2 to 5 milling flutes, wherein optionally the distal end comprises 3 milling flutes.
49. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-48, wherein the distal end comprises from 2 to 4 notches.
50. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-49, wherein the proximal region, central region, and distal region are not expandible or compressible.51 . The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-50, .wherein the device is 3D printed and / or is made from a material selected from stainless steel or an alloy thereof, titanium or an alloy thereof, magnesium or an alloy thereof, polyetheretherketone (PEEK), hydroxyapatite, tricalcium phosphate, tetracalcium phosphate, dicalcium phosphate, BIOGLASS® 45S5, ceramic composites, copper-based materials or composites, cobalt chrome, xenograft biomaterials, and combinations thereof.
52. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-51 , wherein the device comprises a biomaterial that is pre-loaded in the internal channel of the device.
53. The device of claim 52, wherein the biomaterial comprises a plurality of solid dose of biomaterial.
54. The device of claim 53, wherein the plurality of openings in the central region and distal region is sized to have a cross-sectional dimension that is narrower than a cross-sectional dimension of the solid dose of biomaterial.
55. The device of any one of claims 1-13, 15-20, 23, 26-27, 31 -35, and 39-54, wherein the distal end comprises an opening to the internal channel that is tapered.
56. The device of any one of claims 55, wherein the tapered opening of the distal end comprises a cross-sectional dimension that is narrower than the cross-sectional dimension of the solid dose of biomaterial to prevent the solid dose of biomaterial from exiting the distal end.
57. A system for reinforcing a bone of a subject, comprising: a) a device according to any one of claims 1 -13, 15-20, 23, 26-27, 31 -35, and 39-56; and b) one or more implants configured to engage with the device.
58. The system of claim 57, wherein the bone is a long bone and the one or more implants comprises an intramedullary nail having a proximal end and a distal end, wherein the device is a fastener, and wherein the fastener engages with the intramedullary nail to reinforce the bone of the subject.
59. The system of claims 57 or 58, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
60. The system of claims 58 or 59, wherein the intramedullary nail comprises a first hole having a diameter, wherein the fastener is configured to insert in the hole, and wherein the hole is disposed at the proximal end of the intramedullary nail.61 . The system of any one of claims 58-60, wherein the intramedullary nail has a second hole at the distal end and the system further comprises a screw configured to be inserted in the second hole.
62. The system of claim 57, wherein the bone is a long bone and the one or more implants comprises: a) a locking screw; and b) an intramedullary nail having a proximal end and a distal end; wherein the locking screw and the device engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone of the subject.
63. The system of claim 62, wherein the proximal region of the device comprises an external thread configured to engage with the locking screw.
64. The system of claim 62 or claim 63, wherein the locking screw is a lag screw.
65. The system of claim 64, wherein the device and the locking screw have a complementary pitch between 0.25 mm and 15 mm.
66. The system of any one of claims 62-65, wherein the locking screw has a diameter that is greater than a diameter of the device and the intramedullary nail has a curved trapezoidal crosssection.
67. The system of any one of claims 62-66, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
68. The system of any one of claims 62-67, wherein the intramedullary nail comprises a first hole having a diameter and a thread and a second hole distal to and adjacent to the first hole; wherein the locking screw is configured to engage with the first hole and the device is configured to engage with the second hole; and wherein the first hole and second hole are disposed at the proximal end of the intramedullary nail.
69. The system of claim 68, wherein the first and second holes are spaced and angled such that the device and locking screw integrate when both are fully inserted.
70. The system of any one of claims 62-69, wherein the intramedullary nail has a third hole at distal end and the system further comprises a third screw configured to be inserted in the third hole.71 . The system of claim 57, wherein the one or more implants comprises a bone plate with one or more bone plate holes sized to engage with the device.
72. The system of claim 71 , wherein the bone plate comprises two or more bone plate holes.
73. The system of claim 71 or 72, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
74. The system of any one of claims 71 -73, further comprising a plurality of the devices.
75. The system of claim 74, wherein the plurality of devices comprises from 2-12 devices.
76. A system for reinforcing a soft tissue of a subject, comprising a device according to any one of claims 1 -13, 15-20, 23, 26-27, 31 -35, and 39-56, wherein the device is a suture anchor that secures the soft tissue to a bone.
77. The system of claim 76, wherein the device comprises a suture.
78. The system of claim 77, further comprising a plurality of the devices, wherein optionally the plurality of devices comprises from 2-6 devices.
79. A kit comprising: a) a device according to any one of claims 1 -13, 15-20, 23, 26-27, 31 -35, and 39-56, and b) a biomaterial and / or a hydrating fluid.
80. The kit of claim 79, wherein the kit further comprises a dispenser that is configured to inject the biomaterial and / or a hydrating fluid through the internal channel of the device.81 . The kit of claim 80, wherein the dispenser comprises a tube connected to a syringe, a vial, or a reservoir; wherein optionally, the tube further comprises the biomaterial or the hydrating fluid.
82. The kit of any one of claims 79-81 , further comprising an intramedullary nail, wherein the device is a fastener, and wherein the device engages with the intramedullary nail to reinforce a bone of a subject.
83. The kit of claim 82, wherein the bone is a long bone and the device and the intramedullary nail are sized to fit the bone.
84. The kit of claim 82 or claim 83, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
85. The kit of any one of claim 82-84, wherein the intramedullary nail comprises a hole having a diameter, and wherein the device is configured to insert in the hole.
86. The kit of any one of claims 79-81 , further comprising a) a locking screw; and b) an intramedullary nail; wherein the locking screw and the device engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce a bone of a subject.
87. The kit of claim 86, wherein the bone is a long bone and the device, the intramedullary nail, and the locking screw are sized to fit the bone.
88. The kit of claim 86 or claim 87, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
89. The kit of any one of claims 86-88, wherein the intramedullary nail comprises a first hole having a diameter and a thread and a second hole distal to and adjacent to the first hole, and wherein the locking screw is configured to engage with the first hole and the device is configured to engage with the second hole.
90. The kit of claim 89, wherein the first and second holes are spaced and angled such that the device and the locking screw integrate when both are fully inserted.91 . The kit of any one of claims 79-90, further comprising a bone plate with one or more bone plate holes sized to engage with the device.
92. The kit of claim 91 , wherein the bone plate comprises two or more bone plate holes.
93. The kit of claim 91 or claim 92, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
94. The kit of any one of claims 79-81 , wherein the device is a suture anchor that secures a soft tissue to a bone of a subject.
95. The kit of claim 94, wherein the device comprises a suture.
96. The kit of claim 95, further comprising a plurality of the devices, wherein optionally the plurality of suture anchors comprises from 2-6 devices.
97. The kit of any one of claims 79-96, wherein the biomaterial comprises a polymeric adhesive, a bone void filler material, a cement, a phosphoserine-based bioadhesive, a cohesiveness agent, an osteogenic agent, an osteoconductive agent, a solid biomaterial, a solid dose biomaterial, a medicinal agent, a pharmaceutical agent, or a combination thereof.
98. The kit of any one of claims 79-97, wherein the biomaterial comprises a calcium phosphate- based bone cement, a non-self-hardening calcium phosphate based bone void filler, a flowable xenograft bone void filler, phosphoserine, phosphocreatine, polymethacrylate (PMMA), polymethylmethacrylate (PMMA), calcium sulfate, a calcium silicate, a calcium phosphate, a metal alloy, a polysaccharide, a nucleic acid, a carbohydrate, a protein, a polypeptide, a poly(a-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(a-hydroxy alkanoate), a poly(dioxanone), a poly(phosphoester), poly (L-lactide) (PLLA), poly(D,L-lactide) (PDLLA), polyglycolide (PGA), poly(lactide-co-glycolide (PLGA), poly(L-lactide-co-D, L-lactide), poly(D,L-lactide-co-trimethylene carbonate), polyhydroxybutyrate (PHB), poly(E-caprolactone), poly(6-valerolactone), poly(y-butyrolactone), poly(caprolactone), polyacrylic acid, polycarboxylic acid, poly(allylamine hydrochloride), poly(diallyldimethylammonium chloride), poly(ethyleneimine), polypropylene fumarate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene, carbon fibers, polyethylene glycol), polyethylene oxide), poly (vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co- poly(propylene oxide), a block copolymer, poly(ethylene terephthalate)polyamide, a homo-polymer or a co-polymer comprising one or more monomers selected from the group consisting of acrolein potassium, (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 polyphenolic complexing agent selected from a gallotannin, an ellagitannin, a taragallotannin, a caffetannin, a proanthocyanidin, catechin, epicatechin, chlorogenic acid, and arbutin, alginic acid, gum arabic, guar gum, xanthan gum, gelatin, chitin, chitosan, chitosan acetate, chitosan lactate, chondroitin sulfate, N,0-carboxymethyl chitosan, a dextran, fibrin glue, glycerol, hyaluronic acid, sodium hyaluronate, a cellulose, a glucosamine, a proteoglycan, a starch, lactic acid, a poloxamer, sodium glycerophosphate, collagen, glycogen, a keratin, silk, transforming growth factors-beta (TGF- ), an activin, an inhibin, a bone morphogenetic proteins (BMP), an antibiotic, an enzyme inhibitor, an antihistamine, an anti-inflammatory agent, a muscle relaxant, an anti-spasmodic, an analgesic, a prostaglandin, an anti-depressant, a trophic factor, a hormone, or a combination thereof.
99. A method of treating a bone defect in a bone of a subject, comprising implanting the device of any one of claims 1 -13, 15-20, 23, 26-27, 31 -35, and 39-51 into a bone of the subject.
100. The method of claim 99, further comprising fluidly connecting a source of a biomaterial to the internal channel of the device and injecting the biomaterial into the internal channel so that the biomaterial flows out from the plurality of openings into a portion of bone tissue surrounding the device, thereby treating the bone defect.101 . The method of claim 99, wherein the device further comprises a biomaterial pre-loaded into the interior channel of the device.
102. The method of claim 101 , wherein the biomaterial comprises a plurality of solid dose of the biomaterial.
103. The method of claim 102, further comprising fluidly connecting a source of a hydrating fluid to the internal channel of the device and injecting the hydrating fluid into the internal channel of the device to convert the plurality of solid dose of the biomaterial to a fluid form of the biomaterial so that the biomaterial flows out from the plurality of openings in the central region and distal region into a portion of bone tissue surrounding the device, thereby treating the bone defect.
104. The method of claim 100, a volume of biomaterial injected into the internal channel of the device is from about 1 ml to about 20 ml, wherein optionally the volume of the biomaterial is about 2.5 ml, about 5 ml, or about 10 ml.
105. The method of claim 103, wherein injecting a hydrating fluid into the internal channel of the device pre-loaded with biomaterial yields a combined total volume of hydrating fluid and biomaterial of from 1 ml to about 20 ml, wherein optionally the total volume is about 2.5 ml, about 5 ml, or about 10 ml.
106. The method of any one of claims 100 or 103-105, wherein a greater quantity of the biomaterial is delivered to a portion of bone tissue adjacent to the proximal region or the central region than to a portion of bone tissue adjacent to the distal region.
107. The method of any one of claims 100 or 103-105, wherein the biomaterial flows out from the plurality of openings in the central region and distal region in a uniformly radially expanding volume.
108. The method of any one of claims 99-107, wherein the method further comprises inserting a screw or probe through the internal channel of the device.
109. The method of any one of claims 99-108, wherein, prior to inserting the device into the bone, the method further comprises securing a bone plate to the bone by inserting the device through the bone plate hole and into the bone during implantation.
110. The method of claim 109, further comprising fastening the distal end of the device to the distal cortex of the bone.
111. The method of claim 109 or claim 110, wherein the bone plate comprises two or more bone plate holes and / or wherein the method comprises securing the bone plate to the bone using more than one said device.
112. The method of any one of claims 99-111 , wherein the bone defect is outside of a fracture zone.
113. The method of any one of claims 99-11 , wherein the implanting comprises screwing the device into the bone.
114. The method of any one of claims 99-112, wherein the implanting does not comprise screwing the device into the bone.
115. The method of any one of claims 99-114, wherein the implanting comprises inserting the device through a hole drilled into the bone.
116. The method of any one of claims 99-115, wherein the inserting comprises providing torque perpendicularly to a long axis of the device and / or pushing in a proximal to distal direction along the long axis of the device.
117. The method of any one of claims 99-116, further comprising: a) implanting an intramedullary nail into a medullary cavity of the bone; and b) implanting the device into the bone; wherein the device is a fastener that engages with the intramedullary nail to reinforce the bone.
118. The method of claim 117, wherein the bone is a long bone.
119. The method of claim 117 or claim 118, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
120. The method of any one of claims 117-119, wherein the intramedullary nail comprises a hole, and wherein during implantation the device is inserted through the hole.130121 . The method of any one of claims 117-1 0, further comprising implanting a screw into the bone through a second hole in the intramedullary nail that is distal to the device.
122. The method of any one of claims 99-116, further comprising: a) implanting an intramedullary nail into a medullary cavity of the bone; and b) implanting a lag screw into the bone; wherein the lag screw and the device engage with each other to form a compression assembly in conjunction with the intramedullary nail to reinforce the bone.
123. The method of claim 122, wherein the bone is a long bone.
124. The method of claim 122 or claim 123, wherein the bone is a proximal femur, a distal femur, a periarticular sacroiliac region, or a proximal humerus.
125. The method of any one of claims 122-124, wherein the intramedullary nail comprises a first hole and a second hole distal to and adjacent to the first hole, and wherein during implantation the lag screw is inserted through the first hole and the device is inserted through the second hole.
126. The method of any one of claims 122-125, further comprising implanting one or more support screws into the bone through a hole in the intramedullary nail that is distal to the device and the lag screw.
127. A method of treating a soft tissue defect in a soft tissue of a subject, comprising implanting the device of any one of claims 1 -13, 15-20, 23, 26-27, 31 -35, and 39-51 into a bone of the subject to secure the soft tissue to the bone.
128. The method of claim 127, further comprising fluidly connecting a source of a biomaterial to the internal channel of the device and injecting the biomaterial into the internal channel so that the biomaterial flows out from the plurality of openings in the central region and distal region into a portion of bone tissue surrounding the device, thereby securing the device and the soft tissue to the bone.
129. The method of claim 127, wherein the device further comprises a biomaterial pre-loaded into the interior channel of the device.
130. The method of claim 129, wherein the biomaterial comprises a plurality of solid dose of the biomaterial.131 . The method of claim 130, wherein the method further comprises fluidly connecting a source of a hydrating fluid and injecting the hydrating fluid into the internal channel of the device to convert the plurality of solid dose of the biomaterial to a fluid form of the biomaterial so that the biomaterial flows131out from the plurality of openings in the central region and distal region into a portion of bone tissue surrounding the device, thereby securing the device and the soft tissue to the bone.
132. The method of claim 1 8, a volume of biomaterial injected into the internal channel of the device is from about 1 ml to about 20 ml, wherein optionally the volume of the biomaterial is about 2.5 ml, about 5 ml, or about 10 ml.
133. The method of claim 131 , wherein injecting a hydrating fluid into the internal channel of the device pre-loaded with biomaterial yields a combined total volume of hydrating fluid and biomaterial of from 1 ml to about 20 ml, wherein optionally the total volume is about 2.5 ml, about 5 ml, or about 10 ml.
134. The method of any one of claims 128 or 131 -33, wherein a greater quantity of the biomaterial is delivered to a portion of bone tissue adjacent to the proximal region or the central region than to a portion of bone tissue adjacent to the distal region.
135. The method of any one of claims 128 or 131 -33, wherein the biomaterial flows out from the plurality of openings in the central region and distal region in a uniformly radially expanding volume.
136. The method of any one of claims 127-135, wherein the method further comprises inserting a screw or probe through the internal channel of the device.
137. The method of any one of claims 127-136, wherein the implanting comprises screwing the device into the bone.
138. The method of any one of claims 127-136, wherein the implanting does not comprise screwing the device into the bone.
139. The method of any one of claims 127-138, wherein the implanting comprises inserting the device through a hole drilled into the bone.
140. The method of any one of claims 127-139, wherein the inserting comprises providing torque perpendicularly to a long axis of the device and / or pushing in a proximal to distal direction along the long axis of the device.141 . The method of any one of claims 127-140, wherein the device is a suture anchor.
142. The method of claim 141 , wherein the device comprises a suture.
143. The method of claim 142, wherein the method comprises implanting a plurality of the devices into the bone to secure the soft tissue to the bone, wherein optionally the plurality of devices comprises from 2-6 devices.
144. The method of any one of claim 141 -143, further comprising attaching the suture of at least one of the devices to the soft tissue.
145. The method of claim 144, further comprising securing at least one of the devices by way of the suture to a different one of the devices.
146. Cancelled.