Multi-plane fixing plate for fracture repair
阅读说明:本技术 用于骨折修复的多平面固定板 (Multi-plane fixing plate for fracture repair ) 是由 辛格·安舒曼 于 2018-12-19 设计创作,主要内容包括:用于骨折外科手术、例如锁骨骨折外科手术的骨外科手术板装置和方法。该系统和方法可以包括具有特定设计特征的板装置,该特定设计特征包括但不限于装置的多个段中的不同设计、几何形状和构造。(Bone surgical plate apparatus and methods for use in fracture surgery, such as clavicle fracture surgery. The system and method may include a plate device having specific design features including, but not limited to, different designs, geometries, and configurations in multiple sections of the device.)
1. A clavicle plate fixation system, the system comprising:
a plate sized for positioning over the clavicle, the plate comprising a first fastening section, a second fastening section, and a truss section;
wherein the truss section connects the first fastening section and the second fastening section.
2. The system of claim 1, wherein the first fastening segment is offset at a first angle relative to the second fastening segment, wherein the first angle is greater than 60 degrees.
3. The system of claim 1, wherein the first fastening segment is orthogonal to the second fastening segment.
4. The system of claim 1, wherein the first and second fastening segments comprise rounded edges.
5. The system of claim 1, wherein the truss sections are curved.
6. The system of claim 1, wherein the first fastening section comprises a first screw hole and the second fastening section comprises a second screw hole.
7. The system of claim 6, further comprising: a first screw and a second screw, and wherein the first screw is configured to be positioned in the first screw hole and the second screw is configured to be positioned in the second screw hole.
8. The system of claim 7, wherein the first screw is configured to be inserted into the bone in a first direction and the second screw is configured to be inserted into the bone in a second direction, and wherein the first direction is offset from the second direction by a second angle, wherein the second angle is greater than 60 degrees.
9. The system of claim 7, wherein the first screw is configured to be inserted into the bone in a first direction and the second screw is configured to be inserted into the bone in a second direction, and wherein the first direction is orthogonal to the second direction.
10. The system of claim 9, wherein the first and second fastening segments are configured to bend or curve along a width of the plate to adjust the second angle of the first screw relative to the second screw.
11. The system of claim 1, wherein the truss section comprises one or more struts connecting the first fastening section to the second fastening section.
12. The system of claim 1, wherein the first fastening section has a different shape than the second fastening section.
13. The system of claim 1, wherein the first fastening section has the same shape as the second fastening section.
14. The system of claim 1, wherein the first fastening segment, the second fastening segment, or the truss segment comprises one or more folds, perforations, gradient curves, depressions, hinge points, or a combination thereof.
15. The system of claim 1, wherein the first fastening section, the second fastening section, or the truss section comprises one or more wires or suture holes.
16. A clavicle plate fixation system, the system comprising:
a plate sized for positioning over the clavicle, the plate comprising a first fastening section, a second fastening section, and a central section;
wherein the central section connects the first and second fastening sections, and the first and second fastening sections include one or more screw holes; and is
Wherein the first fastening section is offset at a first angle relative to the second fastening section, wherein the first angle is greater than 60 degrees.
17. The system of claim 16, wherein the first fastening segment is orthogonal to the second fastening segment.
18. The system of claim 16, wherein the central section comprises one or more screw holes.
19. The system of claim 16, wherein the central section comprises one or more cutouts.
20. The system of claim 16, wherein the central section comprises a tapered edge.
21. The system of claim 16, wherein the first or second fastening section comprises a tapered distal end.
22. The system of claim 16, wherein the first and second fastening segments comprise rounded edges.
23. The system of claim 16, wherein the plate is curved along a length of the plate.
24. The system of claim 16, wherein the plate is curved along a width of the plate.
25. The system of claim 16, wherein the first fastening section comprises a first screw hole and the second fastening section comprises a second screw hole.
26. The system of claim 25, further comprising: a first screw and a second screw, and wherein the first screw is configured to be positioned in the first screw hole and the second screw is configured to be positioned in the second screw hole.
27. The system of claim 26, wherein the first screw is configured to be inserted into the bone in a first direction and the second screw is configured to be inserted into the bone in a second direction, and wherein the first direction is orthogonal to the second direction.
28. The system of claim 26, wherein the first screw is configured to be inserted into the bone in a first direction and the second screw is configured to be inserted into the bone in a second direction, and wherein the first direction is offset from the second direction by a second angle, wherein the second angle is greater than 60 degrees.
29. The system of claim 16, wherein the central segment and the first and second fastening segments have a uniform thickness.
30. The system of claim 16, further comprising: an inter-segment connection connecting the fastening segment to the central segment, wherein the inter-segment connection is thinner than the central segment and the first and second fastening segments.
31. A bone fixation system comprising one or more of the features of the preceding description.
32. A method of securing a plate to a clavicle comprising one or more of the features of the foregoing description.
Technical Field
The embodiments described herein relate to innovative surgical devices and methods that can be used to significantly improve the clinical outcome of a patient while reducing the healing time, reducing the cost, and increasing the accuracy of the surgical procedure for bone fractures. Embodiments of the bone surgical devices and methods may be particularly effective for fracture surgery, including but not limited to clavicle fracture surgery.
Disclosure of Invention
According to one embodiment, a clavicular plate fixation system may include a plate sized for positioning over a clavicle, the plate including a first fastening section, a second fastening section, and a truss section, wherein the truss section connects the first fastening section and the second fastening section.
The clavicular plate fixation system in the previous paragraph or in other embodiments may include one or more of the following features. The first fastening section may be offset from the second fastening section by a first angle, wherein the first angle is greater than 60 degrees. The first fastening section may be orthogonal to the second fastening section. The first and second fastening sections may include rounded edges. The truss sections may be curved. The first fastening section may include a first screw hole and the second fastening section may include a second screw hole. The clavicular plate fixation system may further comprise a first screw and a second screw, and wherein the first screw is configured to be positioned in the first screw hole and the second screw is configured to be positioned in the second screw hole. The first screw may be configured to be inserted into a bone in a first direction and the second screw may be configured to be inserted into a bone in a second direction, and wherein the first direction is offset from the second direction by a second angle, wherein the second angle is greater than 60 degrees. The first screw may be configured to be inserted into a bone in a first direction and the second screw may be configured to be inserted into a bone in a second direction, and wherein the first direction is orthogonal to the second direction. The first and second fastening sections may be configured to bend or curve along the width of the plate to adjust a second angle of the first screw relative to the second screw. The truss section may include one or more struts connecting the first fastening section to the second fastening section. The first fastening section may have a different shape than the second fastening section. The first fastening section may have the same shape as the second fastening section. The first fastening section, the second fastening section, or the truss section may include one or more folds, perforations, gradient curves, depressions, hinge points, or combinations thereof. The first fastening section, the second fastening section, or the truss section may include one or more threads or suture holes.
According to another embodiment, a clavicular plate fixation system may include a plate sized for positioning over a clavicle, the plate including a first fastening section, a second fastening section, and a central section, wherein the central section connects the first fastening section and the second fastening section, and the first fastening section and the second fastening section include one or more screw holes, and wherein the first fastening section is offset from the second fastening section by a first angle, wherein the first angle is greater than 60 degrees.
The clavicular plate fixation system in the previous paragraph or in other embodiments may include one or more of the following features. The first fastening section may be orthogonal to the second fastening section. The central section may include one or more screw holes. The central portion may include one or more cutouts. The central portion may include a tapered edge. The first or second fastening section may comprise a tapered distal end. The first and second fastening sections may include rounded edges. The plate may be curved along the length of the plate. The plate may be curved along the width of the plate. The first fastening section may include a first screw hole and the second fastening section may include a second screw hole. The system may further include a first screw and a second screw, and wherein the first screw is configured to be positioned in the first screw hole and the second screw is configured to be positioned in the second screw hole. The first screw may be configured to be inserted into a bone in a first direction and the second screw may be configured to be inserted into the bone in a second direction, and wherein the first direction is orthogonal to the second direction. The first screw may be configured to be inserted into a bone in a first direction and the second screw may be configured to be inserted into a bone in a second direction, and wherein the first direction is offset from the second direction by a second angle, wherein the second angle is greater than 60 degrees. The central section and the first and second fastening sections may comprise a uniform thickness. The system may further include an intersegment connection connecting the fastening section to the central section, wherein the intersegment connection is thinner than the central section and the first and second fastening sections.
Any features, components, or details of any arrangement or embodiment disclosed in the present application, including but not limited to any of the plate fixation system embodiments disclosed below, may be interchangeably combined with any other feature, component, or details of any embodiment or arrangement disclosed herein to form new arrangements and embodiments.
Drawings
Various embodiments of the apparatus and methods of the present disclosure are described herein with reference to the accompanying drawings, in which:
FIG. 1 shows an embodiment of a fracture system having multiple segments;
2A-2C illustrate embodiments of fracture systems having various geometries;
FIG. 3 shows a view of an embodiment of a fracture system including an orthopedic surgical plate device and a surgical screw;
FIG. 4 illustrates an embodiment of a fracture system shown on a ossicle model;
5A-5B illustrate an embodiment of a multiplanar surgical plate system having three different planes with screw holes;
FIGS. 5C-5H illustrate embodiments of a multiplanar surgical plate system;
6A-6B and 7 illustrate an embodiment of a multi-planar surgical plate system having three different planes with screw holes;
FIG. 8 shows a bone with a linear surgical plate system;
9A-9C illustrate an embodiment of a bone having a multiplanar surgical plating system with a multiplanar plate and six orthogonal screws;
10A-10G illustrate an embodiment of a screw hole pattern of a multi-planar surgical plate;
FIG. 11 illustrates an embodiment of a multiplanar surgical plate system positioned over the clavicle;
FIG. 12 illustrates a cross-sectional view of a bone and multiplanar surgical plate system; and
fig. 13 illustrates an embodiment of a multiplanar surgical plate.
Detailed Description
Embodiments of the bone surgical plate system may be used in fracture surgery, such as clavicle fracture surgery. The disclosed bone surgical plate system may be used in whole or in part, and each element or aspect of the system may be applied independently of the other. The system includes a plate arrangement having specific design features including, but not limited to, different designs, geometries, and configurations in the truss sections and various fastening sections. In some embodiments, the plate device can be made of materials used for surgical implants and surgical plates, including but not limited to stainless steel and titanium and alloys thereof.
Existing surgical devices for small fracture repair can be large, thick, cumbersome, expensive, painful, and have a short life. Current small fracture repair devices on the market cause irritation and damage to surrounding tissue and nerves. These devices must be removed due to irritation or damage, resulting in additional surgery and excessive expense. It may be helpful to use a more stable device that reduces tissue and nerve damage, reduces incision size, and minimizes the necessity of having to remove the device while still maintaining the stability and fixation requirements of fracture repair, including but not limited to small fracture repair.
Specifically, for clavicular fracture repair, existing surgical devices are designed to attach to the clavicle in a substantially single area (e.g., the anterior, superior, or lateral area of the clavicle). These prior devices allow for fixation of bone screws in a single linear plane or multiple planes that are substantially non-orthogonal and confined to a single region. For example, even if multi-planar fixation is allowed, screw hole locations in different planes are typically offset by a maximum of 50 degrees (around the circumference of the bone along the z-axis transverse to the longitudinal axis). In addition, existing devices are designed to have a minimum width (along the z-axis transverse to the longitudinal axis) to remain secured to a single area of the clavicle. Existing devices having a substantially linear and single zone design limit the bone screw fixation arrangement during surgeon's procedure.
Embodiments of the bone surgical plate system are a substantial improvement over existing devices. In some embodiments, the bone surgical plate system may include a bone surgical plate device having a plurality of segments. The bone surgical plate system may have multiple segments as shown in fig. 1 and 2A-2C. As shown in these figures, in some embodiments, the bone
The surgical plate system may include a multi-planar plate. Multiplanar plates include plates in which the locking screw may enter the bone in more than one plane. Multiplanar plates include plates in which the locking screws may enter the bone in substantially orthogonal planes (offset from each other by an angle greater than 60 degrees). Multiplanar plates include plates in which the locking screws may simultaneously enter the bone from substantially different areas of the bone (e.g., the anterior and superior areas of the clavicle). In some embodiments, the surgical plate system may include a pre-curved plate. In some embodiments, the curvature of the pre-curved plate may facilitate multi-planar fixation and/or substantially orthogonal fixation. The surgical plate system may include a central section (also referred to herein as a truss section). In some embodiments, a surgical plate system may include a plate having three or more segments. The segments may be connected at the center by a central segment or truss-like segment. Additionally, the surgical plate system may include a bendable fastening section. The bendable fastening section may include a wing-like fastening section extending from the central section, and the wing-like section is configured to bend more easily during surgery. The bendable fastening section may be bent to adjust the angle of the screw entry and/or fit more snugly along the bone. Given the various design aspects and embodiments, the surgical plate systems disclosed herein may allow surgeons to better repair various fracture modes within a fractured bone (e.g., transverse, butterfly, and comminuted clavicular fractures).
In some embodiments, the surgical plate system may have a pre-curvature along the width of the device.
The bone surgical plate system utilizes device geometries within the device that are designed to optimize the different segments of the surgical procedure. In some embodiments, the plate device may comprise at least three segments as described in embodiments herein. In some embodiments, the device may have one or more truss sections. In some embodiments, the plate means may comprise perforations in one or more truss sections to assist in bending of the device. The plate device may have any number of truss sections and fastening sections that provide a bent or curved device around the bone to allow fixation to the bone at more than one angle. The design of the plate device is based on the individual segments and how each part of the device works relative to each other (thus having an impact on the surgery and healing). Described herein is a device having three or more segments, however, the device may be made of any number of segments greater than one. As used herein, the term "plate" and the term "plate means" are used interchangeably to refer to a multi-segmented implant.
Fig. 3 shows a view of an embodiment of a fracture system including an orthopedic
The clavicle may also have a medial side and a lateral side. The lateral side of the clavicle refers to the portion of the clavicle that points toward the back or posterior side of the patient's body. The medial side of the clavicle refers to the portion of the clavicle that is directed toward the anterior or anterior side of the patient's body. The clavicle exhibits double curvature. The curvature of the clavicle may include a convex inner curve in the medial half of the clavicle and a concave inner curve in the lateral half of the clavicle.
As discussed in more detail below, the surgical plate device may have varying geometries that are easy to insert while limiting incision size, procedure time, material costs, pain, and the need to remove the implant. In some embodiments, the plate means may comprise a flat surface. In some embodiments, a plate device may be placed along the fracture to secure to individual bone fragments.
As shown in fig. 1 and 2A-2C, the plate arrangement may have an
Fig. 2A-2C illustrate various embodiments of a fracture system including
Fig. 3 shows another embodiment of a fracture system comprising an
As shown in fig. 1-3, the geometry of the truss can be utilized to facilitate fixation of the securing segments to the bone with minimal damage to the surrounding bone, minimal interference with tissue surrounding the bone, and once secured, prevention of movement of bone fragments.
Fig. 4 shows an embodiment of the
In some embodiments, the bone surgical plate system can have various geometries to accommodate different bone types and sizes. In some embodiments, the
In some embodiments, the surgical plating system may be arranged to allow enhanced engagement with bone along the length of the plate and to reduce rotational and lateral movement of the fractured segment (and the plating system).
In some embodiments, the truss sections may include a flat inner and/or outer surface. In some embodiments, the truss sections may be curved.
In some embodiments, at least one fastening section may comprise a flat inner and/or outer surface. In some embodiments, at least one fastening section may be curved.
In some embodiments, at least one of the fastening segments and/or the truss segments may include one or more folds, perforations, gradient curves, or combinations thereof.
The clavicle has a gentle S-shaped curve that varies from person to person. The S-shaped curve may make it challenging to form an S-shaped curve for the bone and to facilitate insertion of the device into the bone.
In some embodiments,
The size of the plate may vary depending on the desired outcome and surgical procedure and the fracture being treated as described herein. For example, the shape and size of the human clavicle is variable and the appropriate implant size can be determined.
Fastening section:
In some embodiments, the
Fig. 1 shows a multi-planar panel having three distinct segments. As shown in fig. 1, the two
In some embodiments, the
In some embodiments, the
In some embodiments, the first and/or
The multiple fastening segments may allow the surgical bone plating system to be fastened to a bone or one or more bone fragments through multiple angles and planes. In some embodiments, the
In some embodiments, the
Truss section:
In some embodiments, the surgical plate may have a truss section that connects the plurality of fastening sections of the plate. Surgical plates for bone surgery and clavicle fracture surgery may face challenges with respect to large implant size, damage to surrounding tissue or bone, and short device life.
In some embodiments, the curved configuration may position the
In some embodiments,
In some embodiments,
In some embodiments, the
In some embodiments, devices utilizing truss segments may allow for greater stability compared to existing implants, while using implants of shorter length and smaller thickness. The shorter length and smaller thickness of the device may simplify surgery, reduce incisions and reduce patient discomfort/deformity. In some embodiments, the multi-planar and multi-segmented systems may cover and contact a greater surface area of the bone and/or fracture site.
Fig. 2A-2C illustrate some embodiments of truss sections. As shown in fig. 2A-2C, the truss segments may have different configurations and may interact with the fastener segments in different ways. In some embodiments, two, four, or
Figure 2B shows
The truss design affects the overall panel properties including, but not limited to, strength, stability, and/or tortuosity. In some embodiments, the truss segments may take many other forms that may allow for device customization based on any type of bone, fracture, and/or anatomy. Any truss design that can achieve and/or alter the properties of the plate devices described herein can be used in a surgical plate device. In some embodiments, the design elements of one fastening section and/or truss section may be mixed and matched to each other. The configuration of the segments is interchangeable to create a wide variety of available plate designs, and the design principles described herein can provide the increased functionality and control needed to improve clinical outcomes.
Locking screw:
Over time, the plate and screws may back out, migrate, become damaged, or cause discomfort, thus requiring a secondary procedure to be performed to remove them. To reduce movement of the plate device, threaded screw holes may be used to allow screws to secure the plate device to the bone. In some embodiments, unthreaded screw holes may be used. In some embodiments, the offset angle of the first and second sections of the bone surgical plating system may allow strategic screw placement that may use smaller screws, thinner screws, and/or fewer screws to secure the device. Smaller and fewer screws may be used because the offset angle configuration of the first and second segments provides increased stability.
The plate means may be secured to the bone using all existing, well known plate or implant securing means and/or techniques.
The bone surgical plate system may be used in a variety of bone procedures. For example, the bone surgical plate system may be used in a clavicle fracture surgery.
Although some details, geometries, and configurations of the device and system are described herein with respect to clavicle fracture surgery, the device may be used in other types of bone surgery as well. For example, the devices and systems described herein may be used in ulnar surgery.
As described herein, the bone surgical plate system may provide increased stability, which may reduce the need for removal or a second procedure. In addition, the bone surgical plate systems described herein may be shorter in length than conventional implants, which may allow for smaller incisions and less scarring. In addition, the bone surgical plate system may reduce patient discomfort and allow the patient to recover faster/better. The bone surgical plate system may be less expensive and may reduce the need for multiple surgeries. In some embodiments, the bone surgical plate system may simplify the surgical procedure, thereby reducing the likelihood of error. The bendable features of the bone surgical plate system can help the device adjust to the anatomy and provide a more customized and personalized implant device.
Fig. 5A-5B illustrate another embodiment of a multi-planar board. As shown in fig. 5A-5B, the
The multi-planar surgical plate has a thickness defined as the distance from the
The multi-planar surgical plate may have a length extending from a medial end to a lateral end of the device. The length may be parallel to a longitudinal axis of the device extending through the central section from the medial end to the lateral end of the device.
The multi-planar surgical plate may have a width that is perpendicular to the width of the longitudinal axis of the device and may be measured while the plate is in a linear or non-curved state.
In some embodiments, the fastening section may have a proximal end at the connection between the fastening section and the connecting section and an opposite distal end.
In some embodiments, the multi-planar surgical plate may have a shorter length and a greater width than conventional surgical plates. In some embodiments, the width of the multiplanar surgical plate, measured from the distal-most end of one fastening segment to the widest end of the opposing fastening segment, may be at least 10mm wide (at least about 10mm wide). In some embodiments, the multi-planar surgical plate may have a width, measured from the distal-most end of one fastening segment to the widest end of the opposing fastening segment, of greater than 10 mm.
In some embodiments, the length of the multiplanar surgical plate may be 10-40% shorter than an equivalent linear/non-orthogonal device for most surgical procedures.
In some embodiments, the average thickness of the multi-planar surgical plate on the device may be less than existing devices. In some embodiments, the desired thickness may be adjusted in any segment or portion of a segment to achieve the desired design goals. In some embodiments, the thickness may vary across the multi-planar surgical plate.
It is expected that the additional width of the device will increase the overall bulk of the device, resulting in greater weight, increased implantation difficulty and greater patient discomfort. As a result, current "single size" clavicle plates can be thin (smaller in width), thick and long. In addition, current clavicle plates may be attached only to the front, top, or side of the clavicle. Current clavicle plates are substantially linear, connecting to bone in a single size or in two planes close to each other (approaching in distance and offset angle, functionally similar to a purely linear plate). The multiplanar surgical plate systems described herein are used to simultaneously fix at least two dimensions (e.g., anterior and superior) of a bone. The multiplanar surgical plate system described herein can reduce the length and thickness of the device compared to prior devices. For example, a common conventional clavicle fixation plate for a large adult clavicle is 120mm long, 8mm wide, and 3.5mm thick. In some embodiments, the dimensions of the multiplanar plate system described herein may be 85mm long, 13mm wide, and 2.5mm thick for an equal size patient. The clavicular plate system is available in a variety of sizes to accommodate patients of different sizes. Similar relative differences in size exist between conventional clavicle plates and the multiplanar plates disclosed herein regardless of the size of the patient. In addition, the multiplanar surgical plate systems described herein may be used for lateral clavicle fractures and diaphyseal fractures. At least by allowing orthogonal fixation of the bone (within a 90 degree fixation range), improved fixation may be achieved.
The multiplanar surgical plate system may provide various advantages during and/or after a surgical procedure, as well as provide healing and recovery advantages to the patient. The multiplanar surgical plate systems described herein can provide shorter implant lengths, which can minimize scar size and reduce pain. The multiplanar surgical plate system described herein can be utilized to perform faster and easier procedures for both the patient and the surgeon. Improved fixation may be due to a reduction in micro-movement of the fragments, which will reduce scarring and provide faster bone healing. Shorter healing times may provide patients with shorter post-operative recovery and faster recovery of daily function. In addition, the lower profile and reduction in irritation may reduce the likelihood of the need to remove the device, reduce pain, eliminate possible exposure to secondary surgery and a second round of anesthesia, and/or reduce the time during which the injured site is unusable.
Fig. 5B illustrates a perspective side view of the multi-planar
Fig. 5B shows the offset angles (e.g., 45 degrees) of the three planes and two fastening section planes of the multi-planar plate. Fig. 5B shows a pre-bent design of the plate that forms at least three different planes for bone screw fixation. In some embodiments, the device may include a pre-bend, or bend along the length of the device during implantation. In such embodiments, the length of the device may be curved to match the curvature of the bone (e.g., the clavicle). In some embodiments, the curvature need not be uniform in the transverse axis (transverse to the longitudinal axis). In some embodiments, the multiplanar plates may be pre-bent to act as a better "frame" or "guide" to align the fractured segments.
Fig. 5B shows a
In some embodiments, the first fastening section and/or the second fastening section may be arranged at an angle, wherein the first fastening section and the second fastening section are offset at a 90 degree angle (about 90 degree angle). In some embodiments, the first and second fastening segments may be offset from each other by any angle greater than 60 degrees (about 60 degrees). In some embodiments, the first and second fastening sections may be offset from each other by any angle between 150 degrees and 60 degrees (about 150 degrees to about 60 degrees). In some embodiments, the first and second fastening sections may be offset from each other at any angle between 180 degrees and 60 degrees (about 180 degrees to about 60 degrees). In some embodiments, the first and second fastening segments may be offset from each other by any angle greater than 180 degrees (about 180 degrees).
In some embodiments, the fastening section may have a proximal end at the connection between the fastening section and the connecting section and an opposite distal end. In some embodiments, the
The embodiments described herein illustrate various fastening section and center section designs and screw hole patterns. However, any combination of fastening section and center section designs and screw hole patterns may be used to provide multiplanar orthogonal (substantially orthogonal) or offset angle fixation of greater than 60 degrees, as described herein.
The multiplanar plate system as shown in figures 5A-5B may include a
In some embodiments, the multiplanar plate system may include three sections, each section including six or more screw holes for bone fixation. In some embodiments, the two or more fastening sections comprise six or more screw holes in positions substantially orthogonal to each other. In some embodiments, the two or more fastening segments include screw holes positioned in an alternating pattern with respect to each other to prevent bone screw interference and provide the surgeon with optimal orthogonal bone screw position selection. The number of screw holes, flats or fastening sections is not limited. In the above example with three segments, there are exponentially larger arrangements of bone screws in three separate planes (each containing six screw holes) from which the surgeon can choose. For example, assuming a surgical procedure requires placement of one bone screw in each of the three segments, the surgeon will have 216 (6^3) different 3-bone screw configurations to choose from. In some embodiments, the fastening section or the central section may be tapered along the length of the section to place the thickest portion of the central section over the fracture site. In some embodiments, the fastening section or the central section may be tapered along the width of the section. In some embodiments, the fastening section and the central section may have different thicknesses throughout the device. The outer edges of various thicknesses and tapers may minimize soft tissue irritation and/or aid or hinder the bendability of the segments.
The surgeon has so many options, particularly from multiple areas of substantially orthogonal planes and bone, that the results and patient outcome are improved, the surgery is faster, quicker, more efficient, healing time is faster, and removal rates for the patient are lower. In some cases, using a single device also prevents a surgeon from using multiple implants in an attempt to achieve some of the benefits achieved by the single multi-planar plate disclosed herein. One example is to adapt a multiplanar plating system to the common fracture pattern of a given fracture. For example, some common clavicle fractures are transverse, butterfly, and comminuted fractures.
Fig. 5C-5E illustrate an embodiment of a multiplanar
For the transverse fracture mode shown in fig. 5C, multiplanar
In the case of a short oblique or "butterfly" fracture, shown in fig. 5D, the multiple angling options of the multiplanar
As shown in fig. 5E, multiplanar
Fig. 5F-5G illustrate various views of an embodiment of a multiplanar
Fig. 5H illustrates a cross-sectional view of a multiplanar
In some embodiments, the multiplanar plate system may be used as a guide/support or "bone fragment locator" for the surgeon during surgery. In some embodiments, the stent action may also help the patient to heal and reduce the implant removal rate. In view of the expanded width of the multiplanar plating system (into multiple bone regions), the multiple segments can be designed to place fractured bone fragments in a more optimal position for healing than prior devices. For example, a truss (or central) section adapted to contact a fracture site in combination with a fastening section adapted to contour a significant portion of bone (greater than 60 degrees around the circumference of the bone) may create a scaffolding effect. In some embodiments, pre-bending the plate to match the shape of the clavicle may help create a scaffolding effect. In some embodiments, pre-bending the fastening section in the z-axis (transverse to the longitudinal axis) to a lesser degree than the underlying bone may allow the surgeon to more practically use the scaffolding effect, as the additional space may make it easier for bone fragments to align (before bending the fastening section down against the bone).
In some embodiments, design considerations related to scaffolding may be balanced against the need to reduce device volume and reduce device contact with the bone. Reducing the volume of the device helps keep the device flexible and easy to access smaller incision sites. It may also help to aid patient comfort. Minimizing plate-to-bone contact can help maintain intra-operative intraosseous circulation, which promotes healing of the fracture site. In some embodiments, the use of cuts in some or all of the segments may help reduce bulk and contact with the bone. In some embodiments, the use of a truss design or a web design may help reduce bulk and bone contact. In some embodiments, maximizing the number of screw holes in a given space may achieve these goals while also maximizing screw fixation options.
As previously described with reference to fig. 1-4, the multiplanar surgical plate system of fig. 5A-5B may provide a shorter device length and/or width to reduce incision size. The multi-planar surgical plate system of fig. 5A-5B may also include stronger anchors with multiple planes of straight bone fixation by providing three or more planes for fixation. Multiple fastening segments with unique designs may provide the surgeon or user flexibility in bending the segments to match various fracture types and/or to fit closely to the bone. The flexibility and ability to mount the multiplanar surgical plating system to bone may reduce pain and device distortion and reduce the need to remove the device.
Fig. 6A-6B illustrate another embodiment of a multiplanar surgical plate system 600 having at least three different planes with screw holes 608 for locking screw fasteners. Fig. 6A shows a central section 603, wherein respective fastening sections 601 and 602 are connected to the central section 603. The fastening sections 601 and 602 are aligned along two different planes than the central section 603. Similar to the embodiments described herein, the fastening sections 601 and 602 may be aligned along at least two planes that are offset from each other by 45 degrees to 135 degrees (about 45 degrees to about 135 degrees) different from the central section 603.
Fig. 6B illustrates a perspective view of the multi-planar surgical plate system of fig. 6A. Fig. 6B shows a central portion 603 and fastening portions 601 and 602 forming three planes. The offset angle (approximately 45 degree offset) of the two fastening section planes is shown in fig. 6B. As shown in fig. 6B, the multiplanar surgical plate system may include a pre-bent design of the plate that is bent prior to surgical use. In other embodiments, the clinician or surgeon may bend or bend the multi-planar surgical plate system prior to or during implantation of the device. Additionally, the fastening segments 601 and 602 may be bendable wing-like segments configured to bend during surgery. The fastening sections 601 and 602 may be bent or curved to adjust the angle at which the screw enters and/or fits more closely along the bone. The cuts in any segment (e.g., the space between arms 611 and 612) may be strategically placed to maximize flexibility while reducing the volume of the plate and the bone contacting surface area. For example, as shown in fig. 6A, a notch may be placed in the center of central portion 603 to allow for greater flexibility of intermediate arms 611 and 612. For some fracture types, the middle portion of the placement plate is placed over the fracture site, thereby reducing the functionality of the plate (and screw hole options) in the middle of the device. Similarly, other portions of the central section or fastening section may be strategically cut. Due to the multi-planar design of the device, the plate system herein can maintain strength and durability, improve rotational stability of fractured bones, increase placement and fastening options for the surgeon, increase malleability to bone shapes, while limiting the bulk of the plate system in terms of critical dimensions (e.g., thickness and length).
The multi-planar surgical plate system of fig. 6A-6B is similar to the system described with reference to fig. 5A-5B, but the fastening section is connected to the central section in a different configuration. Fastening section 601 has an arm 611 and fastening section 602 has an arm 612. Arms 611 and 612 have proximal ends connected to central section 603 and distal ends containing screw holes 608. Arms 611 and 612 are connected to the central section at an angle. For example, an axis extending from the proximal end to the distal end of the arm may pass through the longitudinal axis of the central section at a connection angle of between 20 degrees and 160 degrees (about 20 degrees to about 160 degrees). In the configuration shown in fig. 6A-6B, the arms 611 and 612 of the fastening sections 601 and 602 are attached to the central section 603, forming an "X" shape at the edge of the device. However, the fastening segments may be attached in any configuration or along any portion of the central segment.
The central segment 603 has a length from the medial end to the lateral end of the segment. The fastening segments 601 and 602 have lengths measured from the distal-most end of the most medial arm to the distal-most end of the most lateral arm. As shown in fig. 6A-6B, the length of the fastening sections 601 and 602 may be greater than the length of the central section 603. In other embodiments, the lengths of the fastening sections 601 and 602 and the central section 603 may be the same.
As shown in fig. 6A, the central section 603 may have fewer screw holes 608 than the fastening sections 601 and 602. The central section may have a cut-out to affect the flexibility of the device. In some embodiments, as shown in fig. 5A-5B and 6A-6B, the multi-planar surgical plate device can include a winged arm 613 extending from the central portion 603. The winged arm 613 may be similar to the arms 611 and 612 without bone screws. The winged arms 613 may be contoured to the bone and help secure the device to the bone and prevent movement of the device after implantation. In some embodiments, the screw holes 608 may have a smaller diameter (e.g., 2.7mm) in more regions of the plate than existing plate systems. The use of smaller screws, while maintaining bone stabilization and plate system strength, can accelerate healing rates and improve patient comfort.
Fig. 7 illustrates an embodiment of a bone fixation device. The device is similar to the device described with reference to fig. 5A-5B and 6A-6B, but with a different design of the central and fastening sections. The multiplanar
As illustrated and described in the embodiments herein, the first fastening section may be offset relative to the second fastening section by an angle as described herein. The first and second fastening sections are shown offset with respect to each other in fig. 5A-5B, 6A-6B and 7, however, the angle of offset shown in these figures should not be limiting, but merely represent examples of curvature and offset of the device.
Fig. 8 shows a ossicle (e.g., a clavicle) with a linear surgical plate system 800 that utilizes a linear surgical plate 821 and six substantially parallel screws 822. As shown in fig. 8, linear surgical plate 821 has a length X.
Fig. 9A-9C illustrate an embodiment of a multiplanar surgical plate system 900 having a multiplanar plate 921 and six orthogonal screws. As shown in fig. 9A, the multi-plane plate 921 may have a length Y. The length X of linear plate 821 is greater than the length Y of multiplanar plate 921, however, multiplanar surgical plate systems can provide equivalent or substantially equivalent fixation to bone. For example, orthogonal or offset positioning of screws may provide greater fixation over a shorter distance than the linear plate system shown in fig. 8.
As shown in fig. 9A-9C, the multiplanar surgical plate system may utilize a first set of screws 922 implanted in a first direction and a second set of screws 923 implanted in a second direction. The first set of screws 922 as shown in fig. 9B-9C may be inserted or inserted into or out of the page in the z-direction. As shown in fig. 9B-9C, the second set of screws 923 may be inserted orthogonal or perpendicular to the first set of screws 922 in the y-direction. The offset configuration of screw placement in bone may provide more stable fixation and prevent migration of the device after implantation.
Fig. 10A-10G illustrate embodiments of screw hole patterns of a multi-planar surgical plate. Fig. 10A shows a clover pattern of screw holes on the
Fig. 10C and 10D show barrel-shaped designs of the threaded hole patterns shown in the linear plane, however, when the multi-planar plate is contoured or bent for implantation around, the designs of fig. 10C and 10D will form a barrel or semi-circle shape. The plate of fig. 10C and 10D has a
Fig. 10E shows an embodiment of a multiplanar surgical plate having a spiral shape with
Fig. 10F shows an embodiment of a multiplanar surgical plate having
Fig. 10G shows an embodiment of a multiplanar surgical plate having a web shape with
Fig. 11 illustrates an embodiment of a multiplanar surgical plate system positioned over the clavicle. Fig. 11 shows a posterior butterfly fracture in the clavicle. The
Fig. 12 shows a cross-sectional view of the clavicle 1230 and the multi-planar surgical plate system 1200. The multiplanar surgical plate may have fastening sections 1201 and 1202 and a central section 1203. As shown in fig. 12, the fastening segments 1201 and 1202 of a multiplanar surgical plate may be wrapped around at least two different surfaces of the bone. Two different surfaces of a bone may be orthogonal to each other. For example, the first fastening section 1201 may be positioned on or adjacent to an anterior surface 1242 of a bone and the second fastening section 1202 may be positioned on or adjacent to an upper surface 1243 of the bone. In this configuration, screws 1231 and 1232 may be inserted into the bone at the first and second fastening sections, as shown in fig. 12. In this configuration, a first screw 1231 may be inserted at the upper surface 1243 and a second screw 1232 may be inserted at the front surface 1242. The screws 1231 and 1232 may be orthogonal or substantially orthogonal to each other. The orthogonal or substantially orthogonal orientation of the screws may provide a locked fixation to improve rotational control.
In some embodiments, additional screws and screw holes may be used in conjunction with the central section and may be positioned at an angle of 45 degrees or substantially 45 degrees relative to the screws 1231 in the first and second fastening sections. As shown in fig. 12, the multiplanar surgical device may combine anterior clavicle and uplock bone fixation into a single device. This may provide orthogonal fixation of the clavicle or fixation in the "90-90" range. In some embodiments, the fastening section must contain a minimum rotational distance separation to achieve optimal orthogonal fixation. In some embodiments, the edges of the device may be tapered (or the width of the distal edge is less than the width of the more proximal portion of the device) to reduce irritation, as described herein.
Fig. 13 shows an embodiment of a multiplanar surgical plate having fastening sections 1301 and 1302 and a central section 1303. As shown in fig. 13, the edges of the device may be rounded or curved to remove sharp edges from the plate. The multiplanar plate may have various screw holes 1308 to provide various options to sheath the fracture or compress the fracture fragments together and achieve fixation on the diaphysis or bone axis.
In some embodiments, the central section 1303 may include screw holes 1309. Screw holes 1309 may be used with non-locking screws to position the plate to allow for initial compression and contouring of the plate.
In some embodiments, the plate may have cutouts in the central portion and the fastening section to aid in the bending and contouring of the plate. For example, the fastening section may have one or more cutouts 1335 that allow the panel to be contoured to a desired shape.
In some embodiments, the locking or compression screw for fixation may range in diameter from 3.5mm to 2.4 mm. In some embodiments, the plate and/or screw holes may be used to accommodate any type or size of screw. In some embodiments, the drill bit diameter will be in the range of 2.8 to 2.0 mm. In some embodiments, the plates, screws, and/or screw holes may be used to accommodate any type or size of drill diameter. As described herein, multiple screws of many different sizes may be used over a shorter horizontal length. The shorter length of the multiplanar device may allow for a smaller incision for implantation surgery.
All of the features disclosed in this specification (including any accompanying presentation, claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The present disclosure is not limited to the details of any of the foregoing embodiments. The disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
Various modifications to the embodiments described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the disclosure. Thus, the present disclosure is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and features disclosed herein. Certain embodiments of the present disclosure are encompassed by the claims set forth below or presented in the future.
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