WO2012129169A1

WO2012129169A1 - Apparatus and method for reducing and fixing bone fractures of the leg

Info

Publication number: WO2012129169A1
Application number: PCT/US2012/029671
Authority: WO
Inventors: Mark A. Reiley; Kurt Vedder
Original assignee: Fixes 4 Kids Inc.
Priority date: 2011-03-18
Filing date: 2012-03-19
Publication date: 2012-09-27

Abstract

Devices, systems, and methods for mechanically reducing bone fractures, simple or complex, in children or adults, and involving all bone types, including, e.g., in the leg, involving the femur and/or tibia and/or fibula; in the arm, involving the humerus and/or forearm and/or wrist; and at, in, or near articulating condyles (also called a condylar fracture), e.g. at, in, or near the elbow, or at, in, or near the knee.

Description

Apparatus and Method for Reducing and

Fixing Bone Fractures of the Leg Field of the Invention

The invention generally relates to systems and methods for treating bone fractures, and in particular, systems and methods for treating fractures of the leg. Background of the Invention

Under some circumstances bone fractures may require more intensive treatment than simple immobilization. For example, certain bone fractures may require surgical fixation including placement of pins or other fixation devices which must be precisely positioned to ensure that the fracture is properly aligned during recovery and healing.

Many different treatment options exist for fractures. Known treatment techniques typically depend upon the severity of the fracture, and include simple immobilization, combination manipulation and immobilization, or various operative treatments whereby the fracture is exposed through an incision, the bone fragments are aligned under vision and then held in place by known suitable means.

Fractures may be classified according to the degree of fracture fragment separation, with the resultant treatment being predicated upon the fracture classification. For example, Type 1 fractures are undisplaced or minimally displaced fractures, such as hairline fractures and are treated with simple immobilization in a cast without any manipulation. Type 2 fractures are partially displaced such that the fragments are nearly aligned, with some bony contact present. This type is typically treated by manipulation followed by immobilization in a cast. Type 3 fractures are completely displaced with fracture fragments far apart from each other. A fracture of this type is repaired first by placing the bone fragments in an anatomically correct, appropriate alignment position (reduction) . Following reduction, the fracture is fixated, meaning that the bone fragments are prevented from moving from the reduced placement during the healing process. Type 3 fractures may ultimately require operative treatment, however initially an attempt may be made to reduce the fracture without exposing the bone fragments through an incision. Various fixation means such as wires, bone screws, and rods may be used for fixation of bone fragments. Following fixation, the fracture is allowed to heal.

While the known treatments for type 3 fractures are effective for many, exposure of the fracture through an open incision is invasive. Further, operative time for these difficult to treat fractures may become lengthy and exceed seven hours. Due to the obvious risks involved, improvement in fracture reduction and fixation is desired.

Summary of the Invention

The invention provides devices, systems, and methods for mechanically reducing bone fractures, simple or complex, in children or adults, and involving all bone types, including, e.g., in the leg, involving the femur and/or tibia and/or fibula; in the arm, involving the humerus and/or forearm and/or wrist; and at, in, or near articulating condyles (also called a condylar fracture) , e.g. at, in, or near the elbow, or at, in, or near the knee.

In one embodiment, the invention provides devices, systems, and methods can be applied for mechanically reducing a fractured tibia or femur. Mechanical force reduction vectors, comprising (i) distal traction; (ii) anterior/superior traction; (iii) medial/lateral translation; (iv) varus/valgus rotation; (v) pronation/supination rotation; and (vi) flexion/extension rotation, can be systematically applied to achieve a complete reduction of the fractured bone.

In one embodiment, the device used to achieve reduction of the bone includes expandable segments to manipulate the position of the fractured bones. The device may further use actuators to carry out reduction of the fracture .

Brief Description of the Drawings

Figure 1 is an anatomic view of a human leg.

Figure 2 is an anterior view of a human leg and showing various bones such as the femur, fibula and tibia.

Figure 3 is a posterior view of a human leg and showing various bones such as the femur, fibula and tibia, among others.

Figure 4 is a view similar to that of Figure 2, but showing a tibia fracture.

Figure 5 is a view similar to that of Figure 3, but showing a tibia fracture.

Figures 6A and 6B are anatomic and partially schematic views of the human leg with a tibia fracture, demonstrating the application of a force reduction vector comprising distal traction.

Figures 7A and 7B are anatomic and partially schematic views of the human leg with a tibia fracture, demonstrating the application of a force reduction vector comprising medial/lateral translation or traction. Figures 8A and 8B are anatomic and partially schematic views of the human leg with a tibia fracture, demonstrating the application of a force reduction vector comprising anterior/superior translation.

Figures 9A and 9B are anatomic and partially schematic views of the human leg with a tibia fracture, demonstrating the application of a force reduction vector comprising varus/valgus rotation.

Figures 10A and 10B are anatomic and partially schematic views of the human leg with a tibia fracture, demonstrating the application of a force reduction vector comprising pronation/supination rotation.

Figures 11A and 11B are anatomic and partially schematic views of the human leg with a tibia fracture, demonstrating the application of a force reduction vector comprising flexion/extension rotation.

Figure 12 is a view similar to that of Figure 2, but showing a femur fracture.

Figure 13 is a view similar to that of Figure 3, but showing a femur fracture.

Figures 14A and 14B are anatomic and partially schematic views of the human leg with a femur fracture, demonstrating the application of a force reduction vector comprising distal traction.

Figures 15A and 15B are anatomic and partially schematic views of the human leg with a femur fracture, demonstrating the application of a force reduction vector comprising medial/lateral translation or traction.

Figures 16A and 16B are anatomic and partially schematic views of the human leg with a femur fracture, demonstrating the application of a force reduction vector comprising anterior/superior translation.

Figures 17A and 17B are anatomic and partially schematic views of the human leg with a femur fracture, demonstrating the application of a force reduction vector comprising varus/valgus rotation. Figures 18A and 18B are anatomic and partially schematic views of the human leg with a femur fracture, demonstrating the application of a force reduction vector comprising pronation/supination rotation.

Figures 19A and 19B are anatomic and partially schematic views of the human leg with a femur fracture, demonstrating the application of a force reduction vector comprising flexion/extension rotation.

Figure 20 is a perspective view of an embodiment of an apparatus according to the present invention, directed to reduction of a tibia fracture.

Figure 21 is a perspective view of the embodiment of Figure 20 showing the various force reduction vectors associated with the apparatus.

Figure 22 is a side view of a portion of the device shown in Figure 20 and showing a human foot in phantom.

Figure 23 is a perspective view of the device shown in Figure 20 and showing a human leg in phantom in treatment position.

Figure 24 is a side view of the device illustrated in Figures 20 - 23 and showing relative movement of the bone structure support members.

Figure 25 is a top view of the apparatus shown in Figures 20 - 24 and showing relative movement of the bone structure support members.

Figure 26 is a side view similar to that of Figure 24, and showing further relative movement of the bone structure support members.

Figure 27 is a side view similar to that of Figure 24, and showing further relative movement of the bone structure support members.

Figure 28 is a top view of a foot support member, and showing relative movement.

Figure 29 is a schematic view showing actuators laterally displacing a bone structure.

Figure 30 is a schematic view showing actuators exerting anterior and posterior displacement of a bone structure .

Figures 31- 35 are schematic views showing relative movement of the bone structure support members along the x, y, and z axes and concurrent bone movement.

Figure 36 is a perspective view of a second embodiment of an apparatus according to the present invention, directed to reduction of a femur fracture.

Figure 37 is a perspective view of the apparatus of Figure 36 showing the various force reduction vectors associated with the apparatus.

Figure 38 is a perspective view of the apparatus of Figure 36 showing a human leg in phantom.

Figures 39-41 depict partial schematic representations of a person wearing an apparatus according to the present invention situated on an operating table.

Description of the Preferred Embodiment

I. ANATOMY OF THE HUMAN LEG

Referring first to the anatomical illustrations of Figures 1 - 3, and particularly to Figures 2 and 3, the human leg 10 may be seen to be formed by three major bones namely, the femur 12, the fibula, 14 and the tibia 16. The tibia is the second longest bone of the skeleton, located at the medial side of the leg 10. It articulates with the fibula laterally, the talus distally, and the femur 12 proximally, forming part of the knee joint 18. As seen in Figure 1, the main joints of the human leg include the hip, knee and ankle.

II. FRACTURES

A. Tibia

The tibia is fractured more frequently than any other long bone. Fractures of the tibia (see Figures 4 and 5) and fibula may occur anywhere along the length of the bone. Fractures may be open (compound) or closed (simple) , displaced or non-displaced, angulated or not angulated, stable or unstable. Depending on the severity of the fracture, posterior displacement of the distal fracture fragment and anterior displacement of the proximal fracture fragment may occur. Reduction and fixation of severe fractures may be difficult and time consuming.

In conventional meaning, a fracture is "reduced" by the application of one or more forces to return the bone regions separated and displaced by the fracture back toward the native state of alignment, i.e., that which existed prior to the fracture. In conventional meaning, a fracture is "fixed" following a reduction, by stabilizing the alignment of the reduction, to prevent the reduced bone regions from moving out of reduction as healing occurs.

Depending upon the native anatomic structure of a given fracture site, and the nature of the fracture itself, reduction and fixation of a given fracture can be difficult, inexact, and time consuming.

The morphology and interrelationship of native anatomic structures in a given region of the body can be generally understood by medical professionals using textbooks of human skeletal anatomy along with their knowledge of the site. The physician is also able to ascertain the nature and extent of the fracture in that region of the body using, for example, plain film x-ray, fluoroscopic x-ray, or MRI or CT scanning. Based upon this information, the physician can ascertain the magnitude and direction of forces that ideally should be applied to achieve a complete reduction of the fracture. In this specification, the magnitude and direction of these forces will be called "force reduction vectors." A force reduction vector represents a reduction force operating in a defined direction and magnitude.

These general principles can be applied for the purpose of illustration to the tibia and femur, joined by knee joint. For illustration and spatial reference purposes, as shown in Figures 6A-11B, the leg fracture reduction systems is represented by a reduction vertical axis (RVA) , shown extending along the femur, a reduction horizontal axis (RHA), extending through the knee joint, and a reduction perpendicular axis (RPA) , extending along the tibia.

With reference to the fracture reduction coordinate system shown in Figures 6A-11B, the force reduction vectors required to achieve a complete reduction of the tibia fracture can be identified. It is understood that the recited force vectors are relative directions and angles dependent to assist one in understanding that the present invention is capable of reduction along various axes and positions within the human body. As will now be described in greater detail, there are a total of six possible force reduction vectors for a tibia fracture. These are (i) distal traction (Figures 6A and 6B) ; (ii) medial/lateral translation (Figures 7A and 7B) ; (iii) anterior/superior traction (Figures 8A and 8B) (iv) varus/valgus rotation (Figures 9A and 9B) ; (v) pronation/supination rotation (Figures 10A and 10B) ; and (vi) flexion/extension rotation (Figures 11A and 11B) .

a. Distal Traction

Figure 6A illustrates a first force reduction vector called distal traction. Distal traction comprises a force vector applied along the RHA. As shown in Figure 6B, distal traction along the RHA separates the distal bone region and the proximal fracture region so that subsequent force reduction vectors can be applied to return the proximal and distal bone regions separated and displaced by the fracture back toward the native state of alignment.

b. Medial/Lateral Translation

Figure 7A illustrates a second force reduction vector called medial/lateral translation. Medial/lateral translation comprises a force vector applied along the RPA. As shown in Figure 7B, medial/lateral translation along the RHA moves the fractured end of the distal bone regions across the fractured end of the proximal bone region. Medial/lateral translation returns proximal and distal bone regions that have been medially displaced left or right due to the fracture back toward the native state of alignment.

c. Anterior/Superior Txanslation Figure 8A illustrates a third force reduction vector called anterior/superior traction. Anterior/superior traction comprises a force vector applied along the RPA. As shown in Figure 8B, anterior/superior traction along the RPA lifts (or, in reserve, lowers) the distal bone region as a unit relative to the proximal bone region. Anterior/superior traction returns proximal and distal bone regions that have been displaced due to the fracture forward or backwards back toward the native state of alignment.

d. Varus/Valgus Rotation

Figure 9A illustrates a fourth force reduction vector called varus/valgus rotation. Varus/valgus rotation comprises a rotational force vector (torque) applied about the RVA. As shown in Figure 9B, varus/valgus rotation about the RVA pivots the fractured end of the distal bone region about the longitudinal axis of the proximal bone region. Varus/valgus rotation returns proximal and distal bone regions that have been rotationally displaced due to the fracture back toward the native state of alignment. Varus/valgus rotation serves to bring back into native alignment the posterior, anterior, and medial cortical surfaces along the fracture line.

e. Pronation/Supination Rotation Figure 10A illustrates a fifth force reduction vector called pronation/supination rotation. Pronation/supination rotation comprises a rotational force vector (torque) applied about the RHA. As shown in Figure 10B, pronation/supination rotation about the RHA pivots the fractured end of the distal bone region about the longitudinal axis of distal bone. Like varus/valgus rotation, pronation/supination rotation returns proximal and distal bone regions that have been rotationally displaced due to the fracture back toward the native state of alignment. Pronation/supination rotation also serves to bring back into native alignment the posterior, anterior, and medial cortical surfaces along the fracture line,

f . Flexion/Extension Rotation

Figure 11A illustrates a sixth force reduction vector called flexion/extension rotation. Flexion/extension rotation comprises a rotational force vector (torque) applied about the RPA. As shown in Figure 11A, flexion/extension rotation about the RPA pivots the fractured end of the distal bone region toward the fractured end of the proximal bone region. Flexion/extension rotation returns the fractured ends of the proximal and distal bone regions that have been separated due to the fracture back toward the native state of alignment.

B. Femur

The femur is one of the largest and strongest bones in the body. A femur fracture is a fracture to the thigh bone, often cause by a high-impact accident, e.g. a car crash, or as the cause of osteoporosis. Fractures of the femur (see Figures 12 and 13) and fibula may occur anywhere along the length of the bone. Fractures may be open (compound) or closed (simple) , displaced or non- displaced, angulated or not angulated, stable or unstable. Depending on the severity of the fracture, posterior displacement of the distal fracture fragment and anterior displacement of the proximal fracture fragment may occur. Reduction and fixation of severe fractures may be difficult and time consuming.

As with the tibia, discussed above, the present invention relates to the same general principles of force reduction can be applied for the purpose of illustration for a femur fracture. The same axes, RVA, RHA, and RPA will be used to demonstrate achievement of a complete reduction of the femur fracture. As will now be described in greater detail, there are a total of six possible force reduction vectors for a tibia fracture. These are (i) distal traction (Figures 14A and 14B) ; (ii) medial/lateral translation (Figures 15A and 15B) ; (iii) anterior/superior traction (Figures 16A and 16B) ; (iv) varus/valgus rotation {Figures 17A and 17B) ; (v) pronation/supination rotation (Figures 18A and 18B) ; and (vi) flexion/extension rotation (Figures 19A and 19B) .

a. Distal Traction

Figure 14A illustrates a first force reduction vector called distal traction. Distal traction comprises a force vector applied along the RVA. As shown in Figure 14B, distal traction along the RVA separates the distal bone region and the proximal fracture region so that subsequent force reduction vectors can be applied to return the proximal and distal bone regions separated and displaced by the fracture back toward the native state of alignment.

b. Medial/Lateral Translation

Figure 15A illustrates a second force reduction vector called medial/lateral translation. Medial/lateral translation comprises a force vector applied along the RPA. As shown in Figure 15B, medial/lateral translation along the RPA moves the fractured end of the distal bone regions across the fractured end of the proximal bone region. Medial/lateral translation returns proximal and distal bone regions that have been medially displaced left or right due to the fracture back toward the native state of alignment.

c. Anterior/Superior Translation Figure 16A illustrates a third force reduction vector called anterior/superior traction or translation. Anterior/superior traction comprises a force vector applied along the RHA. As shown in Figure SB, anterior/superior traction along the RHA lifts (or, in reserve, lowers) the distal bone region as a unit relative to the proximal bone region. Anterior/superior traction returns proximal and distal bone regions that have been displaced due to the fracture forward or backwards back toward the native state of alignment.

d. Varus/Valgus Rotation

Figure 17A illustrates a fourth force reduction vector called varus/valgus rotation. Varus/valgus rotation comprises a rotational force vector (torque) applied about the RVA. As shown in Figure 17B, varus/valgus rotation about the RVA pivots the fractured end of the distal bone region about the longitudinal axis of the proximal bone region. Varus/valgus rotation returns proximal and distal bone regions that have been rotationally displaced due to the fracture back toward the native state of alignment. Varus/valgus rotation serves to bring back into native alignment the posterior, anterior, and medial cortical surfaces along the fracture line.

e. Pronation/Supination Rotation Figure 18A illustrates a fifth force reduction vector called pronation/supination rotation. Pronation/supination rotation comprises a rotational force vector (torque) applied about the RHA. As shown in Figure 18B, pronation/supination rotation about the RHA pivots the fractured end of the distal bone region about the longitudinal axis of distal bone. Like varus/valgus rotation, pronation/supination rotation returns proximal and distal bone regions that have been rotationally displaced due to the fracture back toward the native state of alignment. Pronation/supination rotation also serves to bring back into native alignment the posterior, anterior, and medial cortical surfaces along the fracture line.

f . Flexion/Extension Rotation

Figure 19A illustrates a sixth force reduction vector called flexion/extension rotation. Flexion/extension rotation comprises a rotational force vector (torque) applied about the RVA. As shown in Figure 19B, flexion/extension rotation about the RVA pivots the fractured end of the distal bone region toward the fractured end of the proximal bone region. Flexion/extension rotation returns the fractured ends of the proximal and distal bone regions that have been separated due to the fracture back toward the native state of alignment.

III. TREATMENT DEVICE

A. Tibia Device

Referring to now to Figures 20 - 30, an apparatus 20 according to the present invention may be seen. The apparatus 20 as depicted is preferably designed for reduction of a tibia fracture, as described above. The particular reduction forces are depicted further with respect to the apparatus in Figure 21. As viewed particularly in Figures 20 - 23, the apparatus 20 preferably includes a first bone structure support member 22A and a second bone structure support member 22B. Each of the support members 22A, 22B preferably includes a bracket portion or cuff 24 adapted to receive and secure a selected bone structure. The cuffs 24 may include appropriate means for bone structure restraint, such as the straps 26, shown. The cuffs 24 may be formed of any suitable material, such as plastic and may further include a padded liner for further comfort and additional support. Each bone structure support member 22A, 22B further preferably includes a relatively rigid base assembly 30.

The various components of the apparatus 20, including the base assembly 30 may be seen particularly in Figures 20 and 22. As shown, the bone structure support members 22A, 22B may include a cuff portion 24, a base assembly 30, and means for spatial adjustment, such as the flexion rails 32 illustrated. It is to be noted that various means for spatial adjustment may be used, including but not limited to, slot and key arrangements, rack and pinion, or the flexion rail 32 shown. Each of the base assemblies 30 preferably includes at least one adjustment mechanism by which an individual base assembly 30 may be spatially manipulated for movement along a selected plane. Such movements are illustrated in Figures 30 - 35, wherein the base assemblies 30 are seen as being moveable along x, y, and z axes. This relative movement allows the user to manipulate the attached bone structures to a desired anatomical position and fracture reduction. As seen, the base assemblies 30 may be connected to each other in a manner that allows illustrated relative movement, such as by way of the flexion rails 32, shown.

As may be further seen in the Figures, each flexion rail 32 may be provided with an arcuate portion 34; the arcuate portion 34 further including an arcuate slot 36. The arcuate slot 36 is adapted to slidingly receive an adjustable key member 38. Each key member 38 is preferably adjustable to thereby allow arcuate movement of the components and stationary positioning after the desired position is achieved. Although a flexion rail 32 with arcuate slot 36 arrangement is shown to illustrate means for movement of the components, it is to be understood that alternative means for spatial adjustment may be used, such as a rack and pinion combination, by way of non-limiting example. An example of an alternative adjustment arrangement may be viewed in U.S. Patent No. 4,787,794.

With particular reference to Figures 24-28, is may be seen that the apparatus 20 further preferably includes a foot support structure 40. As seen, the foot support structure 40 may be adjustably supported on one end of bone structure support member 22B by adjustment member 42. As seen, adjustment member 42 may be slidingly engaged in base assembly 30 to permit movement in the direction of arrows seen in Figure 25. The foot support structure 40 may be further adapted for movement in the direction of the arrows depicted in Figure 27. The arrows demonstrate the various reduction forces discussed above, which can be performed individually to carry out a complete fraction reduction.

As seen in Figures 29 and 30, the present device may further include a series of expandable segments 44. The expandable segments 44 are preferably positioned to aid in aligning selected bones, as Figures 14 and 15 illustrate.

The expandable segments 44 may be made from material that assumes a relatively normal lay-flat condition, but allow them to be enlarged or expanded into an enlarged condition that preferentially presses against an adjacent bone structure. Since the base assembly 30 and bracket 24 is less flexible that the material of the expandable segments 44, the expandable segments 44 expand preferentially inward into the interior of the apparatus 20. By pressing against a selected bone structure, the expandable segments 44 preferentially move the position of the selected bone structure to thereby align and reduce the fracture.

To affect preferential enlargement of the expandable segments 44, the apparatus 20 may further include an array of actuators (not shown) that form or are otherwise carried within the expandable segments 44. The actuators 44 comprise structures that can be controllably enlarged, either by conveyance of liquid or air (either of which may be called a "fluid") or by mechanical means, from a normal collapsed condition to an enlarged, expanded condition. It is by operation of the actuators that the expandable segments 44 enlarge to preferentially press against a selected, adjacent bone structure, to thereby move and align the bone structures involved the fracture. Operation of the actuators 46 affects predictable movements of the selected bone structure in desired directions with the objective to reduce the fracture for pinning or other stabilization. The size and configuration of the expandable segments 44 may vary depending on the location of the fracture and size of the effected bone structures. The actuators also may take various forms and configuration, depending upon the size and configuration of the expandable segments 44. In the illustrated embodiment of Figures 29 and 30, the actuators may take the form of inflatable bodies that form or are carried within the expandable segments 44. The expandable bodies can comprise, e.g., balloons made from elastic, non-elastic, or semi-elastic materials. The expandable segments 44 may be coupled to a source of expansion air or liquid so that each expandable body 44 may be selectively enlarged or collapsed in a controlled manner as desired. It is also within the scope of this invention to control expandable body 44 movement by other means, including, but not limited to the use of mechanical jack type lifters or small elevators (not shown) that are carried within the expandable segments 44. Mechanical actuators such as that contemplated may selectively and individually be operated to achieve the desired results, as just described.

It is to be understood that the present device may be used in conjunction with a fixation device, such as a fixation assistance jig having at least one aperture adapted to receive at least one fixation member through the jig and into the aligned fracture.

B. Femur Device

As will be appreciated and reference above, the present invention is also capable of a complete fraction reduction of a femur, as well. As shown in Figures 36-38, an apparatus 120, similar to that of apparatus 20 can be used for such a reduction. The particular reduction forces, as described above, are depicted further with respect to the apparatus in Figure 37. The apparatus 120 preferably includes a first bone structure support member 122A and a second bone structure support member 122B. Each of the support members 22A, 22B preferably includes a bracket portion or cuff 124 adapted to receive and secure a selected bone structure. The cuffs 124 may include appropriate means for bone structure restraint, such as the straps 126, shown. The cuffs 124 may be formed of any suitable material, such as plastic and may further include a padded liner for further comfort and additional support. Each bone structure support member 22A, 22B further preferably includes a relatively rigid base assembly 130.

The various components of the apparatus 120, including the base assembly 30 may be seen particularly in Figures 36 and 38. As shown, the bone structure support members 122A, 122B may include a cuff portion 24, a base assembly 130, and means for spatial adjustment, such as the flexion rails 132 illustrated. It is to be noted that various means for spatial adjustment may be used, including but not limited to, slot and key arrangements, rack and pinion, or the flexion rail 32 shown. Each of the base assemblies 130 preferably includes at least one adjustment mechanism by which an individual base assembly 130 may be spatially manipulated for movement along a selected plane and with respect to a particular force reduction vector, as described above. This relative movement allows the user to manipulate the attached bone structures to a desired anatomical position and fracture reduction. As seen, the base assemblies 130 may be connected to each other in a manner that allows illustrated relative movement, such as by way of the flexion rails 132, shown.

As may be further seen in the Figures, each flexion rail 132 may be provided with an arcuate portion 134; the arcuate portion 34 further including an arcuate slot 136. The arcuate slot 36 is adapted to slidingly receive an adjustable key member 138. Each key member 138 is preferably adjustable to thereby allow arcuate movement of the components and stationary positioning after the desired position is achieved. Although a flexion rail 32 with arcuate slot 136 arrangement is shown to illustrate means for movement of the components, it is to be understood that alternative means for spatial adjustment may be used, such as a rack and pinion combination, by way of non-limiting example.

Still referring to Figures 36-38, the apparatus 120 may further include a series of expandable segments 144. The expandable segments 144 are preferably positioned to aid in aligning selected bones, similar to the segments 44 described with respect to the apparatus 20 illustrated previously in Figures 14 and 15. It is understood that the expandable segments can be arranged and designed in the same fashion as the segments 44, discussed above.

As can be seen with reference to apparatus 20, 120, the devices perform similarly, with the distinction being the arrangement of the support members 22a, 122a and 22b, 122b, respectively being located in a mirror-like arrangement, dependent on the bone of which a reduction is being performed. That is, the support member 22a is located on/around the tibia to reduce and fix a tibia fracture, while the support member 122a is located on/around the femur to reduce and fix a femur fraction. However the general principles with respect to reduction and fixation are the same.

Likewise, as stated with the apparatus 20, it is to be understood that the apparatus 120 may be used in conjunction with a fixation device, such as a fixation assistance jig having at least one aperture adapted to receive at least one fixation member through the jig and into the aligned fracture.

IV. USE OF THE DEVICE

The apparatuses 20 and 120 may be further used to practice a method of reducing a fracture. The method may include the steps of: providing an apparatus sized and shaped to re-align a bone fracture toward a desired anatomic position, the apparatus including at least a first and a second bone structure support member, an optional fixation assistance jig having at least one aperture, and a fixation member sized and configured for engagement with aperture; positioning a first bone structure adjacent a first bone structure support member; securing said first bone structure to said first support member; positioning a second bone structure adjacent a second bone structure support member; securing said second bone structure to said second support member; providing at least one of said first bone structure and said second bone structure with a fracture; manipulating said first and second support members relative to one another in at least two planes or force reduction vectors to thereby re-align the fracture toward a desired anatomic position. The method may further include the step of providing the apparatus with at least one apertured jig member, and fixing the fracture while in aligned position. The step of fixing the fracture may include the step of inserting at least one fixation member through the jig and into the aligned fracture.

The method may further include reduction of the fracture in at least one of the six movements described above.

The device may be further described as a frame for manipulating at least two bone structures that articulate about a joint, at least one bone structure having a fracture, said frame including a first bone structure support member and a second bone structure support member, said first support member being coupled to said second support member for relative movement in at least two different planes to establish a desired orientation of the fracture for fixation. The frame may further include a jig member for guidance of a selected fixation means into the fracture at the desired orientation.

The frame further including a detachable stationary frame having a link to maintain the desired relative bone structure position during ambulation. For example, as shown in Figures 39-41, the apparatus 20, 120 is shown connected to a support table 5. A frame 7 connects the apparatus 20, 120 to the support table 5. The frame 7 can be adjusted to fit the support table 5, determinative on the apparatus 20 (Figure 39) or 120 (Figure 40) being used, or the position of the support table 5 (Figure 41) . The frame 7 will allow the apparatus 20, 120 to have a secure base from which to carry out the mechanical reductions, above.

Claims

1. A bone fracture reduction apparatus comprising a first bone support member; and

a second bone support member;

wherein the first and second bone support members are adjustably connected to allow reduction of the bone fracture in at least one of six possible force reduction vectors, distal traction, medial/lateral translation, anterior/superior traction, varus/valgus rotation, pronation/supination rotation, and flexion/extension rotation.

2. The bone fracture reduction apparatus according to claim further comprising

a series of expandable segments located on at least one of the first and second bone support members for carrying out the bone fracture reduction.

3. The bone fracture reduction apparatus according to claims 1 or 2 further comprising actuators attached to at least one of the first and second bone support members for carrying out the bone fracture reduction.

4. The bone structure apparatus according to any of the preceding claims further comprising a foot support structure attached to one of the first and second bone support members .

5. The bone structure apparatus according to any of the preceding claims further comprising a frame for attaching the apparatus to a patient platform.

6. The bone structure apparatus according to claim 5, wherein the patient platform is selected from a family of patient platforms comprising an operating table, a gurney, a bed, a chair, and a fracture reduction table.

7. The bone structure apparatus according to any of the preceding claims wherein the bone being treated is a femur .

8. The bone structure apparatus according to claims 1 through 6 wherein the bone being treated is a tibia.

9. The bone structure apparatus according to any of the preceding claims further comprising

a first reduction mechanism located on one of the first and second bone support members that is sized and configured to apply to the bone fracture a first mechanical force vector that moves the bone fracture into a first anatomic orientation, including a mechanism that is sized and configured to mechanically interact with the first fracture reduction mechanism to maintain a desired alignment in the first anatomic orientation, and

a second reduction mechanism on one of the first and second bone support members that is sized and configured to apply to the bone fracture, independent of the application of the first mechanical force vector, a second mechanical force vector that moves the bone fracture into alignment in a second anatomic orientation different than the first anatomic orientation, including a mechanism that is sized and configured to mechanically interact with the second reduction mechanism to maintain a desired alignment in the second anatomic orientation.

10. The bone structure apparatus according to any of the preceding claims wherein the series of expandable segments comprise the first and second reduction mechanism.

11. A method for reducing a bone fracture comprising locating a patient platform that is sized and configured to support an individual having a bone fracture, providing a mechanical bone fracture reduction apparatus according to any one of the preceding claims, joining the fixture to the patient platform to support the bone fracture, and

operating the apparatus to apply force vectors to mechanically reduce the bone fracture