WO2023230343A1

WO2023230343A1 - System for immobilizing bone and methods of using the same

Info

Publication number: WO2023230343A1
Application number: PCT/US2023/023723
Authority: WO
Inventors: Dankward HÖNTZSCH; Andrew DEAGON; Kiran AGARWAL-HARDING
Original assignee: Sona Global Limited
Priority date: 2022-05-27
Filing date: 2023-05-26
Publication date: 2023-11-30

Abstract

Systems and methods for immobilizing bone, the system including, a plurality of rods to provide a framework for immobilizing a fractured bone; a plurality of clamps, each of the plurality of clamps having at least two opposing portions between which at least one rod can be accommodated; and a plurality of pins, at least one of the plurality of pins received within one of the plurality of clamps and to engage the fractured bone to immobilize the framework about the fractured bone.

Description

SYSTEM FOR IMMOBILIZING BONE AND METHODS OF USING THE SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63/346,630, filed May 27, 2022, for all subject matter common to both applications and is hereby incorporated by reference in its entirety.

FIELD OF INVENTION

[0002] The present disclosure relates to orthopedic and trauma procedures. In particular, external fixation of the skeletal system to temporarily stabilize fractures.

BACKGROUND

[0003] External fixation of the skeletal system includes methods, and procedures, which can be used by orthopedic and trauma surgeons for temporary as well as definitive stabilization of fractures and/or dislocations of the skeleton. These techniques can be used, for example, in open fracture when methods of fracture internal fixation are not possible due to severe soft tissue injury or limited resources. External fixation works by placing pins, e.g., schanz pins, through the patient’s skin and threaded into the broken bone, and then constructing an external frame by connecting the pins to rods on the outside of the body. Specialized clamps can secure the pins to the rods, or as the case may be from rods to other rods, to create a highly customizable, modular assembly. The assembly can fixate the bones in an adequate position to initially stabilize the fracture.

[0004] However, current fixation assemblies suffer from high costs. The most expensive component of the external fixation modular assembly is the clamp, which in the American market the industry standard versions can cost between $400 and $600 each. For example, the highest burden of musculoskeletal trauma is so often borne by poor and economically vulnerable populations that have inadequate access to essential orthopedic trauma care. As a result, external fixation is often unavailable to many who desperately need it due to limited resources and unaffordable cost of these devices. [0005] Therefore, there is a need for inexpensive and robust skeletal immobilization systems and methods. For example, the instant disclosure provides affordable external fixator clamp systems and methods of use which can cost less than about $5 to manufacture and assemble. Rather than attempting to replicate the designs of more expensive clamps, the instant system uses a novel approach the clamp designs. The instant system can provide a clamp and an external fixator assembly with rods and pins held together by the instant clamp.

SUMMARY

[0006] In an embodiment, a system for immobilizing bone is provided herein. The system includes a plurality of rods to provide a framework for immobilizing a fractured bone; a plurality of clamps, each of the plurality of clamps having at least two opposing portions between which at least one rod can be accommodated; and a plurality of pins, at least one of the plurality of pins received within one of the plurality of clamps and to engage the fractured bone to immobilize the framework about the fractured bone.

[0007] In some embodiments, the at least two opposing portions each can include a through hole. The clamp can further include a bolt arranged within the respective through hole and retained by a nut. The at least two opposing portions can be generally rectangular. At least two body portions can each include at least one additional cutout sized to retain the at least one pin. The at least two opposing portions can be substantially identical. The at least two opposing portions can include respective troughs, the troughs can be arc shaped. The at least two opposing portions can include respective troughs that contact at least one of the plurality of rods at four points of contact. The at least one pin can be at least two pins.

[0008] In an embodiment, a method of immobilizing a bone is provided herein. The method includes, inserting a first pin partially within fractured bone on one side of the fracture and a second pin partially within the fracture bone on the other side of the fracture; inserting a first clamp on the first pin and a second clamp on the second pin, the first clamp and the second clamp respectively including at least two opposing portions having cutouts sized to receive the respective one of the first and second pins when the at least two opposing portions are arranged in face to face contact; and creating a framework for immobilizing about the fractured bone including inserting at least one rod into the first and second clamps. [0009] In some embodiments, the at least two opposing portions, of the respective first and second clamps, can each include a through hole. The first clamp and second clamp can each further include a bolt arranged within the respective through hole and retained by a nut. The method can further include hand tightening the respective nut onto the respective bolt. The nuts can be hand tightened to allow free rotation and sliding of the first and second pins and rod within the first and second clamp. The nuts can be maximally tightened to fix the framework. The at least two opposing portions can be generally rectangular. The at least two opposing portions can be substantially identical. The cutouts can be arc shaped. The cutouts can be defined by a right angle. The cutouts can contact the respective first and second pin at four points of contact each.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] These and other characteristics of the present disclosure will be more fully understood by reference to the following detailed description in conjunction with the attached drawings, in which:

[0011] FIG. 1 is a perspective view of a clamp system according to another embodiment;

[0012] FIGS. 2A-2D are perspective views of a clamp of the clamp system of FIG. 1.

[0013] FIG. 3A is a front side view of a body portion of the clamp of FIG. 1.

[0014] FIG. 3B is a right-side view of a body portion of the clamp of FIG. 1.

[0015] FIG. 3C is a top side view of a body portion of the clamp of FIG. 1.

[0016] FIG. 3D is a perspective view of a body portion of the clamp of FIG. 2.

[0017] FIG. 4 is a perspective view of a clamp according to an embodiment.

[0018] FIGS. 5A-5N illustrate a method of installing a clamp system according to an embodiment.

[0019] FIG. 6 illustrates alternative arrangement of a clamp system according to an embodiment.

[0020] While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.

DETAILED DESCRIPTION

[0021] Wherein like parts are designated by like reference numerals throughout, illustrate an example embodiment or embodiments of the device of dispensing liquid to an eye, according to the present disclosure. Although the present disclosure will be described with reference to the example embodiment or embodiments illustrated in the figures, it should be understood that many alternative forms can embody the present disclosure. One of skill in the art will additionally appreciate different ways to alter the parameters of the embodiment s) disclosed, such as the size, shape, or type of elements or materials, in a manner still in keeping with the spirit and scope of the present disclosure.

[0022] Turning to FIG. 1, a modular external fixator assembly, or system, 100 is illustrated. In general, the instant disclosure provides for a simple to manufacture and skeletal fixation system 100. The instant system 100 can make use of, generally, geometrically consistent clamps 3 that are able to clamp together bone fixation pins 2 to at least one rod 1. The design of the instant clamps 3 can allow for consistent volume scale manufacturing using a number of alternative manufacturing options without complex assemblies. As a result, the instant system can be produced for a relatively low cost while maintaining safety and health standards to open bone fixation procedures up to a larger pool of patients who otherwise could not afford such a procedure.

[0023] The external fixator assembly 100 can generally include any number of rods 1, pins 2, and clamps 3. In some embodiments, the assembly 100 can include at least two pins 2 which can each be fixed within at least a portion of a bone, extending outward through a portion of the skin of the patient, as seen in FIGS. 5A-5N. As shown in FIG. 1, a modular external fixator assembly 100 can be constructed using at least one rod 1, a plurality of pins 2, and at least one clamp 3. In some embodiments, a plurality of rods 1, pins 2, and clamps 3 can be used, depending on the complexity and needs of the procedure. In general, the clamp 3 functions to fix the pins 2 and the rod 1 relative to one another once the clamp 3 is locked. In an unlocked configuration, the clamp 3 can rotate about, and along, both the pins 2 and rod 1, providing a number of degrees of freedom to ensure that the bone, in which the pins 2 are disposed in, can be fixed in the correct orientation to ensure proper healing.

[0024] As shown in FIGS. 2A, 2B, 2C, and 2D, the instant clamp 3 can include a plurality of pieces. In some embodiments, the clamp 3 can, in general, include at least two clamp body portions 10, a bolt 20, and a nut 30. In addition, in some embodiments, metal washers, lock washers, or rubber washers may be added to the assembly between the head of the bolt 20 and the body portion 10, between the nut 30 and the body portion 10, or both. In accordance with an embodiment, the bolt 20 can be partially or fully threaded. The diameter of the bolt 20 may vary depending on the size of body portion 10, as well as the intended rods 1 and pins 2. In an embodiment, the bolt can be 6 mm in diameter with a hexagonal head. A standard, off-the-shelf stainless steel M6 bolt may be used. In accordance with an embodiment, the nut 30 may be a hex nut, or any other nut, including a lock nut.

[0025] In some embodiments, the clamp 3 can include four simple, substantially identical, body portions 10a, 10b, 10c, lOd. Each body portion 10 can include one or more troughs 12, 14, as shown in FIG. 3A that can accommodate a rod 1 or a pin 2. The troughs 12, 14 can be cut to specific depths and widths according to the intended pins 2 or rods 1 they are meant to grip. The body portion 10 can additionally include a through hole 16 which can be drilled in the center of each body portion 10, generally perpendicular to the troughs 12, 14. Alternatively, the through hole 16 can extend through the body 10 at any location or any orientation.

[0026] The thickness of body portion 10, as seen in at least FIGS. 3 A and 3B, can be determined by the depth required for the largest trough 12, 14, for the rod 1 or pin 2 which has the largest diameter. The body portion 10 can have a thickness T. In some embodiments, the thickness T can be about 5 mm to about 15 mm, and in some embodiments, the thickness T can be about 10.2 mm. As seen in FIG. 3C, body portion 10 can have a generally rectangular shape which can allow for easy alignment of the multiple body portion lOa-d pieces arranged in series on the bolt 20. The width W of the body portion 10, in an embodiment, can be about 10 mm to about 30 mm, in some embodiments the width can be about 20 mm. In some embodiments, the length L can be about 30 mm to about 40 mm, and in some embodiments the length can be about 35.5 mm. Other geometric shapes and dimensions are considered to be within the scope of this disclosure. In some embodiments, edges of body portion 10 can be rounded to prevent crack propagation in the metal, or left as sharp edges.

[0027] In some embodiments, the through hole 16 can be drilled between a pin trough 12 and a rod trough 14. The through hole 16 can have a generally circular cross-sectional shape to accommodate a round bolt 20. In an embodiment, the through hole 16 can have a diameter of about 5 mm to about 8 mm, in an embodiment the diameter can be about 6.5 mm. The generally circular cross-sectional shape of hole 16 can allow for free rotation of the clamp 3 components about the axis of the bolt 20 for easier handling and a highly customizable assembly of the external fixator construct.

[0028] In an embodiment, the pin trough 12 can extend into the same surface of body portion 10 as the rod trough 14 and can be oriented in the same direction as the pin trough 12. The pin trough 12 can be designed such that the pin troughs 12 on two opposite facing body portions 10 create a pin slot that accommodates the pin 2. The pin slot can grip the pin 2 when the clamp is tightened with the bolt 20 and nut 30. To that end the pin trough 12 can be provided with a profile, or geometry, which can complement the shape of the pin 2, and can be cut to varying depths to accommodate different diameters of pins 2. FIG. 3A illustrates one embodiment of the body portion 10 having a pin trough 12 that can be round, or have an arc, which can accommodate a pin 2, e.g., a 5 mm pin 2. In some embodiments, the pin trough 12 can be cut at a right angle as shown in FIG. 4. In the alternative embodiment, the pin trough 12 may be smoothened to prevent crack propagation in the metal. Further, the pin trough can have any geometric shape that can be used to clamp the pin 2. As illustrated in FIG. 2C, in some embodiments, the pin trough 12 can be shaped so that there are four points of contact on the pin 2 in the clamp’s slot, created between two body portions 10 facing each other. This can be further enhanced by adding crush ribs or notches (not shown) at the contact points.

[0029] In an embodiment, the rod trough 14 can extend into the same surface of body portion 10 as the pin trough 12 and can be oriented in the same direction as the pin trough 12. The rod trough 14 can be designed such that the pin troughs 14 on two opposite facing body portions 10 can create a rod slot that can accommodate a rod 1 and can grip the rod 1 when the clamp is tightened with the bolt 20 and nut 30. To that end the rod trough 14 can be provided with a profile, or geometry, which can complement the shape of the rod 1, and can be cut to varying depths to accommodate different diameters of rods 1. FIG. 3 A illustrates one embodiment of the body portion 10 having a rod trough 14 that can be round, or having an arc, which can accommodate a rod 1, e.g., an 11 mm rod. Alternatively, the rod trough 14 can be cut at a right angle as shown in FIG. 5, and the apex of this angled rod trough 14 may be smoothened to prevent crack propagation in the metal. Further, the rod trough 14 can have any geometric shape that can be used to clamp the rod 1. As illustrated in FIG. 3C, in some embodiments, the rod trough 14 can be shaped so that there are four points of contact on the rod in the clamp’s slot, created between two Part A pieces facing each other. This can be further enhanced by adding crush ribs or notches (not shown) at the contact points.

[0030] In one embodiment, the instant clamps 3 are designed for use fixator rods 1. In some embodiments the rods 1 can be standard, or conventional external fixator rods 1. Such rods 1 can be used by multiple manufacturers and producers of external fixators. In general, the rods 1 can be circular in cross section which can allow for free rotation of the clamp 3 around the axis of the rod 1. Such rotation of the clamp 3 around the rod 1 can allow for highly customizable assembly of the external fixator assembly 100. The rods 1 can come in a variety of lengths for various clinical applications and the size of the patient intended for treatment. In some embodiments, the length of the rod 1, used in modular assemblies, can be between about 100 mm and about 600 mm, though the rod 1 can be shorter and longer than this range. The rods 1 can come in a variety of diameters for various clinical applications and the size of the patient or bone intended for treatment. In some embodiments, the diameter of the rod 1 can be between about 8 mm and about 12 mm. In some embodiments, the most diameter can be about 11 mm for external fixation of femurs, tibias, and pelvises. The rods 1, in some embodiments, can be made of carbon fiber, stainless steel, aluminum, or any other metal with sufficient rigidity to prevent bending. Stainless steel rods 1 can be tubes with an outer wall thickness of about 1.0 mm to about 2.0 mm. While exemplary embodiments of rods 1 are discussed herein, the rod 1 can have other lengths, diameters, materials, or cross-sectional shapes (e g , square, diamond, triangle, etc ).

[0031] In an embodiment, the pins 2 used with a clamp 1. The pins 2 can have a fluted tip with screw threads to allow the pin 2 to be self-drilling into a bone. Alternatively, in place of the screw threads, the pin 2 may include other fixation structure arranged on a distal portion of the pin 2 to retain the pin in the bone, once inserted. In the illustrated embodiment, the pins 2 can have a generally circular cross section. The generally circular cross section can allow for free rotation of the clamp 3 around an axis of the pin for highly customizable assembly of the external fixator construct. The free rotation of the clamp 3 about the pin 2 can, additionally, facilitate driving the pin 2 into the bone without rotation of the clamp 3 during the insertion. The pins 2 can come in a variety of lengths for various clinical applications and the size of the patient intended for treatment. The pins 2 can come in a variety of diameters for various clinical applications and the size of the patient or bone intended for treatment. In some embodiments, the pin 2 can have a diameter between about 2 mm to about 6 mm. In some embodiments, for example when used for external fixation of femurs, tibias, and pelvises, the pin 2 can have a diameter between about 5 mm to about 6 mm. The pins 2 can be made of stainless steel, but the material may vary. While exemplary embodiments of pins 2 are discussed herein, the pin 2 can have other lengths, diameters, materials, or cross-sectional shapes (e.g., square, diamond, triangle, etc.) so long as they can be at least partially fixated into a bone. In some embodiments, the pins 2 can be standard Shantz pins. Shantz pins can commonly be used by multiple manufacturers and producers of external fixators and pins 2. Alternatively, other commercially available pins 2 can be used in the instant system, so long as the pin 2 can function as a bone penetrating element, adapted to pass through, or into, bone.

[0032] In embodiments where four body portions lOa-d are used, the four body portions lOa-d can be assembled, in series, along a bolt 20 and retained together with a nut 30, with the bolt 20 extending through respective through holes 16 of the body portions lOa-d. Free motion between 1) the body portions lOa-d and the bolt, 2) the pins 2 and the body portions lOa-d, and 3) the rods 1 and the body portions lOa-d, can allow for highly versatile adjustment of the assembly 100 with at least five degrees of freedom. The five degrees of freedom of the assembly can include, but are not limited to: 1) position of the body portions lOa-d along the rod 1, 2) the position of the body portions lOa-d along a respective pin 2, 3) rotation of the body portions lOa-d on rod 1, 4) rotation of the body portions lOa-d on respective pins 2, and 5) rotation between clamp 3 components about the bolt 20.

[0033] The clamp 3 can be ideal for the resource-limited setting, as the clamp 3 can be produced cheaply, and can even be produced locally. In an embodiment, the body portions lOa-d can be manufactured from metal bar stock. For example, the metal bar stock can be aluminum, stainless steel, or any other hard metal resistant to high stresses. Then subtractive manufacturing processes can be used to create the various features of the body portions lOa-d, including milling and drilling.

In some cases, some forms of plastic may be used to mold the body portions lOa-d.

[0034] In some embodiments, body portion 10 can be designed for extrusion mold manufacturing. In some embodiments where the body portion 10 may have right-angled troughs 12, 14 cut for the pin and the rod, as shown in FIG. 4. In such an embodiment, the troughs 12, 14 can be cut to accommodate an 11 mm rod and 5 mm pin, but the depth can be adjusted to accommodate different sizes of the pin and the rod. The through hole 16 can be drilled in the middle of the body portion 10, perpendicular to the troughs 12, 14, and can be designed to accommodate an M6 bolt, though other sizes could be used and the hole drilled at a different diameter accordingly. The through hole 16 can be upsized slightly (e.g., about 0.5 mm) to allow some tilting of the pieces in the final assembly 100 for ease of use, but without too much tilting that would cause the pieces to catch on the bolt threads. In some cases, the bases of the right-angle troughs can be rounded to prevent crack propagation, and the edges can be rounded for ease of handling and improved aesthetics. The smooth surfaces may be sand blasted or roughened to increase friction between the pieces in the final assembly.

[0035] The clamp 3 can be designed to be used in modular external fixation assemblies 100, for example. The design depicted in the figures above can be used with 5 mm pins (Item #2) and 11 mm rods (Item #1), however it can except 6 mm pins (Item #2) and 12 mm rods (Item #1), or other sizes as needed. The clamp 3 can be designed both for pin-to-rod and rod-to-rod connections. In combination with the pins and rods, the clamp 3 can be designed for modular assembly and be highly customizable depending on the fracture for which it is used to stabilize. In some embodiments, troughs 12, 14 can be cut for, e.g., 5 mm pins 2 and for, e.g., 11 mm rods 1. The clamp 3 can be suited for management of unstable pelvic fractures; diaphyseal humerus, femur, and tibia fractures; as well as periarticular fractures with application in hip spanning, knee spanning, and ankle spanning external fixation.

[0036] In an embodiment, a method of use can include the assembly of a clamp 3 with, for example, four body portions lOa-d, a bolt 20, and a nut 30 as shown in FIGS. 1, 2A, and 2B. The clamp 3 components can be autoclaved for sterilization prior to or after assembly. The clamp 3 may also be used without sterilization, depending on the clinical scenario and according to the surgeon’s discretion. In some embodiments, pins 2 can be placed into a patient’s bones 60a, 60b as needed to control fracture fragments in standard external fixation construct, as seen for example in FIG. 5A. In some embodiments, at least two or more pins 2 can be used to construct the assembly 100. In some embodiments, four pins 2 can be used, depending on the clinical situation and the surgeon’s discretion. The step of inserting pins can usually be done in the operating room under sterile conditions, with the aid of fluoroscopy to aid in positioning of the pins 2 and fracture reduction. The pins 2 can be secured within the bones 60a, 60b and clamps 3 can be threaded there on through the pin trough 12. The pins 2 can be connected to rods 1 using the clamp 3. For example, as illustrated in FIG. 5B, a rod 1 can be inserted into a clamp 3 by offsetting one body portion 10a from the remainder of the clamp 3 to allow the rod 1 to be inserted into the rod trough 14. Once the rod 1 or pin 2 is seated in the appropriate trough 12, 14 in one body portion 10a of a clamp 3, the other half of the clamp component can be rotated into place, then the clamp tightened. In some embodiments, the clamps 3 can be designed with a bolt 20 of appropriate length to allow the clamp 3 to be opened wide enough for insertion of the rod 1. Each clamp 3 can have four body portions lOa-d to create two halves - each comprised of two body portion 10 pieces. The four body portions lOa-d can be threaded onto a bolt 20. In some embodiments, the fractured bone 60a, 60b can be set once confirming adequate bone purchase by the pins 2, preferably with two cortices of fixation, by connecting one rod 1 of an appropriate length to both pins 2 with two clamps 3, as shown in FIGS. 3C and 3D. The fracture can be reduced, then the nut 30 can be fully tighten onto the bolt 20, as shown in FIG. 3D. In some embodiments, the respective bolts 20 and respective nuts 30 can all be provisionally tightened by hand to allow free rotation and sliding of the pins 2 and rods 1 within the clamp 3 to allow for free rotation of the two clamp halves on the bolt 20.

[0037] As needed, the clamp 3 may be used to connect rods 1 to other rods 1. Each half of the clamp 3 can accept either a pin 2 or a rod 1, and thus one full clamp 3 can grip both a pin 2 and a rod 1, or the clamp 3 can accept a rod 1 and a rod 1. For example, as shown in FIGS. 5E and 5F, an additional clamp 3 can be arranged on the rod 1 at the approximate position where a medical professional may plan to place an additional pin and orient the clamp 3 in such a way that the second clamp faces the anticipated drilling site and the bolts of the additional clamp 3 can be provisionally finger-tightened. Using the pin trough 12 defined hole on a free side of the clamp 3 as a drill guide, as shown in FIG. 5G, the medical professional can predrill a path for an additional pin 2 defining a hole 62, as seen in FIG. 5H. In some embodiments, the various pins 3 may not be parallel to one another to increase the stability and pull-out strength of the final assembly 100. In some embodiments, a pin 2 can be inserted into the newly drilled hole 62 and the clamp can be fully tightened with a wrench, as shown in FIG. 51.

[0038] In some embodiments, a fourth clamp 3 can be arranged via side loading onto the rod 1, as shown in FIG. 5J. The process of FIGS. 5J-5L, for drilling an additional hole in the bone and securing an additional pin 2 into the bone can be accomplished via the same method described with respect to FIGS. 5C-5H, and will not be repeated for the sake of brevity. In an embodiment, a second rod 1 can be inserted into the third and fourth clamps, shown in FIG. 5M, to span the fracture site and the medical professional can ensure that all the clamps 3 are fully tightened with the wrench. In some embodiments, the second rod 1 can increase stability and safety of the assembly 100, for example in cases of comminuted fractures and fractures of the femur. FIG. 5M illustrates a longer second rod 1 which can be inserted into the first and second clamps 3. Alternatively, the second rod 1 can be inserted into the inner third and fourth clamps 3, as shown in FIG. 5N. It is contemplated that other arrangements of rods 1, pins 2, and clamps 3 can be implimented depending on the medical case, as shown in FIG. 6.

[0039] In some embodiments, once the fracture is reduced with arrangement of the assembly 100, usually with the assistance of intraoperative fluoroscopy, and then held in a reduced position, the bolts 20 and nuts 30 on all the clamps 3 can be maximally tightened. Additional rods 1 and clamps 3 may be added to the assembly to neutralize any weakness in the construct and provide further stiffness and rigidity. The clamp 3 may not have interdigitating teeth to lock torsion between the two clamp components, so the clamps may only be used in a frame, with neutralization rods to minimize torsional strain placed on any individual clamp.

[0040] As utilized herein, the terms “comprises” and “comprising” are intended to be construed as being inclusive, not exclusive. As utilized herein, the terms “exemplary”, “example”, and “illustrative”, are intended to mean “serving as an example, instance, or illustration” and should not be construed as indicating, or not indicating, a preferred or advantageous configuration relative to other configurations. As utilized herein, the terms “about”, “generally”, and “approximately” are intended to cover variations that may existing in the upper and lower limits of the ranges of subjective or objective values, such as variations in properties, parameters, sizes, and dimensions. In one non-limiting example, the terms “about”, “generally”, and “approximately” mean at, or plus 10 percent or less, or minus 10 percent or less. In one non-limiting example, the terms “about”, “generally”, and “approximately” mean sufficiently close to be deemed by one of skill in the art in the relevant field to be included. As utilized herein, the term “substantially” refers to the complete or nearly complete extend or degree of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art. For example, an object that is “substantially” circular would mean that the object is either completely a circle to mathematically determinable limits, or nearly a circle as would be recognized or understood by one of skill in the art. The exact allowable degree of deviation from absolute completeness may in some instances depend on the specific context. However, in general, the nearness of completion will be so as to have the same overall result as if absolute and total completion were achieved or obtained. The use of “substantially” is equally applicable when utilized in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art.

[0041] Numerous modifications and alternative embodiments of the present disclosure will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present disclosure. Details of the structure may vary substantially without departing from the spirit of the present disclosure, and exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention. It is intended that the present disclosure be limited only to the extent required by the appended claims and the applicable rules of law.

Claims

What is claimed:

1. A system for immobilizing bone, the system comprising, a plurality of rods to provide a framework for immobilizing a fractured bone; a plurality of clamps, each of the plurality of clamps having at least two opposing portions between which at least one rod can be accommodated; and a plurality of pins, at least one of the plurality of pins received within one of the plurality of clamps and to engage the fractured bone to immobilize the framework about the fractured bone.

2. The system of claim 1, wherein the at least two opposing portions each include a through hole.

3. The system of claim 2, the clamp further including a bolt arranged within the respective through hole and retained by a nut.

4. The system of claim 1, wherein the at least two opposing portions are generally rectangular.

5. The system of claim 1, wherein at least two body portions each include at least one additional cutout sized to retain the at least one pin.

6. The system of claim 1, wherein the at least two opposing portions are substantially identical.

7. The system of claim 1, wherein the at least two opposing portions include respective troughs, the troughs being arc shaped.

8. The system of claim 1, wherein the at least two opposing portions include respective troughs that contact at least one of the plurality of rods at four points of contact.

9. The system of claim 1, wherein the at least one pin is at least two pins.

10. A method of immobilizing a bone, the method comprising, inserting a first pin partially within fractured bone on one side of the fracture and a second pin partially within the fracture bone on the other side of the fracture; inserting a first clamp on the first pin and a second clamp on the second pin, the first clamp and the second clamp respectively including at least two opposing portions having cutouts sized to receive the respective one of the first and second pins when the at least two opposing portions are arranged in face to face contact; and creating a framework for immobilizing about the fractured bone including inserting at least one rod into the first and second clamps.

11. The method of claim 10, wherein the at least two opposing portions, of the respective first and second clamps, each include a through hole.

12. The method of claim 11, the first clamp and second clamp each further including a bolt arranged within the respective through hole and retained by a nut.

13. The method of claim 12, the method further including hand tightening the respective nut onto the respective bolt.

14. The method of claim 13, wherein the nuts are hand tightened to allow free rotation and sliding of the first and second pins and rod within the first and second clamp.

15. The method of claim 14, wherein the nuts are maximally tightened to fix the framework.

16. The method of claim 10, wherein the at least two opposing portions are generally rectangular.

17. The method of claim 10, wherein the at least two opposing portions are substantially identical.

18. The method of claim 10, wherein the cutouts are arc shaped.

19. The method of claim 10, wherein the cutouts are defined by a right angle.

20. The method of claim 10, wherein the cutouts contact the respective first and second pin at four points of contact each.