WO2025177040A1 - Antero-medial locking compression plate for distal shaft humerus fracture treatment and its utilization method thereof - Google Patents

Abstract

The present invention discloses a distal humerus anteromedial locking compression plate device for treating fractures of a lower third shaft of a humerus bone in adults. The device comprises a pre-contoured metallic plate (20) made of medical-grade titanium or stainless steel alloy, designed for fixation of the humerus shaft and distal humerus. The plate features a proximal portion, a transitional portion, and a distal portion, with a plurality of holes (110) along its length for accommodating screws, including locking screws (120), non-locking screws, drill guides, and extensions. Notably, the plate exhibits front-to-back and side-to-side curves in the distal portion, enhancing its adaptation to the natural curvature of the distal humerus. The invention further includes distal most anchors (120A) and (120B) for fixation in the distal-most two holes, allowing secure fixation inside the bone in a pre-defined angle of insertion in corresponding screw holes 110A and 110B, ensuring optimal stability for treating fractures.

Description

ANTERO-MEDIAL LOCKING COMPRESSION PLATE FOR DISTAL SHAFT HUMERUS FRACTURE TREATMENT AND ITS UTILIZATION METHOD THEREOF

FIELD OF THE INVENTION

The present disclosure relates generally to surgical devices, systems, and methods for internal fixation of fractures of bones such as the humerus (arm bone). More particularly, the present invention provides a specifically contoured bone plating device for distal(lower) third fractures of the humerus shaft that fit a corresponding specific portion or portions of the distal lower portion of the humerus.

BACKGROUND OF THE INVENTION

The arm bone(humerus) is divided into three parts. The uppermost part is the proximal humerus which forms the shoulder joint by articulating with another bone scapula. The middle part is the shaft humerus and the lowermost part is the distal humerus which helps in forming elbow joints with forearm bones i.e., radius and ulna.

The lower portion of the humerus has a complex three-dimensional anatomy. The distal or lower extremity of the humerus is flattened, and curved slightly forward; it ends below in a broad, articular surface, which is divided into two parts. Projecting on either side are the lateral and medial epicondyles.

The medial end of the articular surface is called as trochlea. Above the back part of the trochlea is a deep triangular depression, the olecranon fossa, in which the summit of the olecranon process of the ulna(one of the forearm bones) is received in an extension of the forearm.

The lateral portion of the articular surface consists of a smooth, rounded eminence, named the capitulum of the humerus; it articulates with the cup-shaped depression on the head of the radius(another bone of the forearm).

The coronoid fossa is the medial hollow part on the anterior (front) surface of the distal humerus. The coronoid fossa (on the front) is smaller than the olecranon fossa(on the back) and receives the coronoid process(a projection on a cup-shaped part) of the ulna during maximum flexion(bending) of the elbow.

The epicondyles are extra-articular (outside the joint) portions above and on the sides of articular surfaces. The lateral epicondyle is a small, tuberculated eminence. The medial epicondyle, larger and more prominent than the lateral, is directed a little backward; it gives attachment to the Pronator teres, and a common tendon of origin of some of the Flexor muscles of the forearm; the ulnar nerve runs in a groove on the back of this epicondyle.

Fractures of the arm that occur just above the olecranon(on the back part) and coronoid fossa(on the front part) and in the lower part of the shaft are called distal shaft humerus fractures. Since this area of bone has many muscles attached to it, the chances of displacement of fracture fragments are high if treated in plaster of Paris cast. Hence most of these fractures in adults are fixed with some sort of plates and screws so that fracture ends are aligned securely till the time fracture healing takes place naturally.

Such bone plates typically comprise small, generally flat, elongated sections of metal. The sections contain round and sometimes elongated screw holes at various points along their lengths for fastening the sections to bone. The sections may be linear or curved for positioning on various portions of the bone. Because no surface of the human skeleton is flat, existing plates must be extensively twisted and bent during surgery to conform to portions of the skeleton on which they are to be affixed. During a two to three-hour surgical procedure, as much as 15 to 30 minutes may be expended shaping and re-shaping metal plates. This additional time increases anesthesia requirements and operating room time and increases the potential for infection. The inevitable over-bending and under-bending of plates during efforts to form the plates during surgery creates crimps and other surface imperfections in the plates and it alters their structural integrity due to metal fatigue.

Surface imperfections can also irritate overlying tissue. Weakened structure due to excessive bending and twisting in the operating room is of paramount importance because it can lead to structural failure later; these plates frequently must remain in patients' bones for the rest of their lives and must undergo tremendous stress.

Many advances have been made in the last three decades in the manner the fracture is fixed with plates and screws to optimize the environment around the fracture which is conducive to fracture healing. One such advancement is minimally invasive plate osteosynthesis (MIPO).

There is a current trend of fixing & treating most long bone fractures with small incisions(cuts) i.e., the MIPO technique. This technique is less commonly employed in the shaft humerus because some important nerves and blood vessels of the arm are nearby. The lower third shaft humerus fractures are even more difficult to treat by small cuts(MIPO) as there is a nerve called as Radial nerve which is at risk of injury if we apply a plate blindly to a small incision(cut). There are devices(plates) available to fix this fracture that can only be applied from the lateral side(outer side of the armjbut they must be applied by long cuts keeping the nerve under vision to avoid injury to this Radial nerve but the advantageous small cuts can’t be utilized with this device.

So, there are two major problems while treating fractures of the distal humerus shaft, the first being the inability to perform MIPO by traditional lateral approach with the plates that are available in the market, and the second there are no pre-contoured plates that can be applied in a MIPO manner if some other route is taken to insert the plate other than the lateral approach.

Medial side plates which are currently available for applying over the distal part of the humerus are intended to be used only in very low articular fractures (fractures inside the joint portion) of the distal humerus and not the distal shaft fractures which are higher up. Another problem is that they cannot be used in MIPO mode as they require long incisions(cuts) for their application. No device is available in the market for lower shaft humerus fractures which can be applied by minimally invasive MIPO mode using small cuts from the medial side (inner side of arm).

In view of the foregoing discussion, it is portrayed that there is a need to have aNovel Distal Humerus Antero-medial Locking Compression Plate (DHAM LCP) for treating fractures of the lower third shaft of the humerus bonein adults. The device deals with the lower third shaft humerus fractures. This device can be inserted from the anteromedial surface (front of the inner side of the arm) of the humerus. The specific pre-contoured design would fit the complex 3D curves of this part of the bone and the pre-designed screw holes would be in such an orientation that they will fix the device to the bone without breaching any nerve, artery, or joint surface. It would be an LCP (locking compression plate) where screws can be locked only in a certain orientation with the plate.

SUMMARY OF THE INVENTION

The present disclosure seeks to provide aDistal Humerus Antero-medial Locking Compression Plate (DHAM LCP) for treating fractures of the lower third shaft of the humerus bone in adults. This pre-contoured device can be inserted from the anteromedial surface(front of the inner side of the arm)of the humerus in a minimally invasive MIPO mode by small incisions(cuts). No pre-contoured plate is available for the lower shaft humerus, which can be applied by small incisionsfrom the medial side(inner side) of the arm. The specific pre-contoured design would fit the complex 3D anatomy of this part of bone and the pre-designed screw holes would be in such an orientation that they will fix the device to the bone without breaching any nerve, artery, or joint surface. It would be an LCP(locking compression plate) where screws can be locked only in a certain orientation with the plate.

In an embodiment, a distal humerus anteromedial locking compression plate (DHAM- LCP) device for treating fractures of thelower third shaft of a humerus bone in adults is disclosed. The device includes a pre-contoured metallic plate made of medical-grade titanium or stainless-steel alloy, the pre-contoured metallic plate having a proximal portion, a transitional portion, and a distal portionfor fixation of a humerus shaft and distal humerus.

The plate features at least three curves, one in a side-to-side direction and two curves from a front-to-back direction. The side-to-side curve situated in the distal portion of the plate, would have an angulation of 15 degrees. There will be two curves from front to back, both in the distal portion of the plate, with first and the distal most being 23 degrees and second, a little proximal being 40 degrees.

The device further includes a plurality of holes fabricated at a user-defined distance from the distal portion of the plate along its entire length, adapted to accommodate plain or threaded screws and configured to accommodate locking screws, non-locking screws, drill guides, and extensions.

The device further includes two anchors in distal-most two holes of the plate that go inside a bone only in a user-defined direction by locking a screw head into a screw hole in a particular direction. The holes further up beyond these two holes would be combi-hole pattern, so that plate can be anchored to the bone with the help of locking screws as well as non-locking screws. The locking screws can be inserted only in a pre-defined fixed direction, while the non-locking holes provide the freedom of putting the screw in a non-fixed direction.

The invention describes a method for utilizing an anteromedial distal humerus-locking compression plate in a minimally invasive fashion. The method includes making two small incisions(cuts), one in a region of themedial condyle (projected inner portion of lower part of the humerus) and another intheupper third of the arm.

The method further includes pushing theplate upwards from the first lower incision, towards theshaft and retrieving the upper end of the plate through the second incision.

The method further includes using the plate in a manner that distal and proximal portions are anchored to a bone with bone screws, leaving middle portion screw holes empty to avoid injury to nerves and vessels passing through that area.

An object of the present disclosure is to develop a device(DHAM LCP) intended to fix fractures of the lower third shaft of the humerus(arm bone) which can be applied in a minimally invasive mode(small cuts) with minimal blood lossless pain after the operation and minimal scar after healing.

Another object of the present disclosure is to provide a new plate and method of using the same, which is of a robust design, as well as be easily and efficiently manufactured.

Yet another object of the present invention is to deliver an expeditious and cost- effective method of manufacturing a pre-contoured plate to best fit the contours of the anteromedial (front of the inner side of the arm near the elbow) distal humerus anatomy.

To further clarify the advantages and features of the present disclosure, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail in the accompanying drawings.

BRIEF DESCRIPTION OF FIGURES

These and other features, aspects, and advantages of the present disclosure will become better understood when the following detailed description is read concerning the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:

Figure 1 illustrates a front-view depiction of distal humerusanteromedial locking compression plate (DHAM-LCP) attached to a humerus;

Figure 2 illustrates a side-view depiction of a preferred embodiment of the invention attached to a humerus; Figure 3 illustrates a back-side view depiction of a preferred embodiment of the invention;

Figure 4 illustrates a side-view depiction of a preferred embodiment of the invention;

Figure 5 illustrates another front-view depiction of a preferred embodiment of the invention;

Figure 6 illustrates another side-view depiction of a preferred embodiment of the invention;

Figure 7 illustrates a preferred embodiment of the incisions(cuts) on the front view of the arm for the insertion of the invention; and

Figure 8 illustrates a flow chart of a method for utilizing distal humerus anteromedial locking compression plate (DHAM-LCP) in a minimally invasive fashion.

Further, skilled artisans will appreciate those elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help to improve understanding of aspects of the present disclosure. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

DETAILED DESCRIPTION:

To promote an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.

It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof.

Reference throughout this specification to “an aspect”, “another aspect” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment. The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises...a" does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.

Embodiments of the present disclosure will be described below in detail concerning the accompanying drawings.

Referring to Figure 1, a front-view depiction of distal humerus anteromedial locking compression plate (DHAMP-LCP) attached to a humerus is illustrated in accordance with an embodiment of the present disclosure. The device 1000 includes a pre-contoured metallic plate (20) made of medical-grade titanium or stainless steel alloy, the pre-contoured metallic plate (20) having a proximal portion (50), a transitional portion (40), and a distal portion (30) for fixation of a humerus shaft and distal humerus.

The humerus bone(130) has a metaphyseal portion (135), distal end (140), a medial condyle (150), a medial trochlea (160), a lateral epicondyle (170), a lateral capitellum (180), an anterior coronoid fossa (190), a posterior aspect or side (200) (Figure 2), a posterior olecranon fossa (210) (Figure 2) and main body or shaft (220), and so forth. It is understood that the articular surface of the lower or distal end (140) of the humerus occupies the anterior trochlea (160) medially, coronoid fossa (190) in the middle, and lateral capitellum (180). Posterior articular surface fossa is the olecranon fossa (210). The trochlea (160) articulates with the corresponding forearm bone ulna and the anterior coronoid fossa (190) accommodates the corresponding projection of the forearm bone ulna ie the coronoid process. The lateral capitellum (180) articulates with the other forearm bone radius (its head).

The plate (20) features at least three curves, one in a side-to-side direction and two curves froma front-to-back direction. The side-to-side curve situated in the distal portion of the plate (30), would have an angulation of 15 degrees. There will be two curves from front to back, both in the distal portion of the plate, with first and the distal most being 23 degrees and second, a little proximal being 40 degrees.

In an embodiment, a plurality of holes (110) are fabricated at a user-defined distance from the distal portion (30) of the plate along its entire length, adapted to accommodate plain or threaded screws (120) and configured to accommodate locking screws (120), non-locking screws, drill guides, and extensions. In another embodiment, the plate (20) contemplates providing with apertures (110A), (HOB), (HOC), (110D) and so on proximally for general positioning bone anchors (120A), (120B), (120C), (120D) and so on, on anteromedial aspect of distal aspect (150) and shaft (220).

In an embodiment, the device further includes two anchors (120) in distal-most two holes of the plate (20) and go inside the bone only in a user-defined direction by locking a screw heads into a screw holes in a particular direction.lt is further contemplated that the last two anchors 120 A and 120B will have fixed pre-defined angles of insertion in corresponding screw holes 110A and l lOB.The holes further up beyond these two holes would be combi- hole pattern, so that plate can be anchored to the bone with the help of locking screws as well as non-locking screws. The locking screws can be inserted only in a pre-defined fixed direction, while the non-locking holes provide the freedom of putting the screw in a nonfixed direction.

In another embodiment, the plate (20) has a constant width of 12 mm along its entire length, having a first (lower/ distal) end (30), a shaft and or middle (40), a second (upper/ proximal) end (50), atop surface (60), a bottom surface (70), a width (80), a length (90), and a thickness (100), wherein the second end 50 may include a tapered portion 55 generally making second end 50 narrower.

In another embodiment, the proximal portion of the plate (50) is designed to fit an anteromedial surface of the humerus shaft, whereas the distal portion of the plate (30) is shaped to match an anteromedial portion of the distal humerus.

In another embodiment, the screw holes along the distal portion of the plate (30) is specifically designed to accommodate screws for fixation of the distal humerus, including the medial condyle (150), trochlea (160), and a metaphyseal portion of the humerus (135). The shaft portion (40)of the plate may be essentially straight in the coronal plane in the upper portion with a slight curve in the sagittal plane in the lower portion to match the natural curve of the distal third humerus bone.

In another embodiment, the length (90) may be about 12 centimeters such that the length (90) may be shorter or longer, wherein the width (80) may be about 12 mm along the whole length of the plate (20) except at the flared upper end 55. In a preferred embodiment, thethickness (100) may be about 3.5 mm such that the thickness (100) may be greater or lesser.

In another embodiment, the plate (20) is to be positioned on an anteromedial humerus such that thelowerend (30) does not extend past medial condyle (150) and theupper end (50) may be positioned on the shaft (220) of the humerus (130) and may have a varying length (90). The middle portion (40) of the plate (20) may be lying underneath a neurovascular structure and not be filled with screws as decided by the surgeon intra-operatively. The screw holes along the shaft portion of the plate may accommodate screws for affixing the plate to the anteromedial surface of the humerus shaft. There may be a transitional portion of the plate that will curve between the shaft portion and the distal portion both in the coronal as well as sagittal plane. The curve of this transitional Zone may contour to the distal antero-medialmetaphyseal portion of the humerus. There may be screw holes or other holes placed along this transitional Zone of the plate.

Figure 2 illustrates a side-view depiction of a preferred embodiment of the invention attached to a humerus.

Figure 3 illustrates a back-side view depiction of a preferred embodiment of the invention. More in particular the figure depicts the bottom surface of the plate (70)„ a width 80, and a length 90. It is understood that plate 20 may have many configurations, including length and side (left vs right) and so forth and the current invention should not be considered limited to the illustrations. It is also contemplated that second end 50 may include a tapered portion 55, generally making second end 50 narrower.

Figure 4 illustrates a side-view depiction of a preferred embodiment of the invention. The thickness 100 maybe about 3.5mm along the whole length of the plate. It is understood that thickness 100 maybe greater or lesser. This figure also illustrates the curvatures of the plate in the sagittal view, i.e. front to back which is further elaborated in the subsequent figures. It is also understood that invention 1000 may utilize bone anchors 120 such as but not limited to known locking or non-locking screws as indicated for certain types of fractures and non-unions of the distal humerus. The bone anchors 120generally cooperate with plate 20 apertures 110 to secure the various bone anchors 120 to the humerus 130 as will also be discussed in greater detail below.

It is contemplated that bone anchors 120 may generally be placed along plate 20 first(distal) end 30, shaft or middle 40, and second (proximal) end 50. It is further contemplated that bone anchors 120 may be pointed in such a trajectory as to gain fixation in the medial condyle 150, and trochlea 160 for the screw 120A, in the metaphyseal region 135 for the screw 120B, while in the opposite cortex of shaft 130 for the screws 120C, 120D, and so on.

Figure 5 illustrates another front-view depiction of a preferred embodiment of the invention. Invention 1000 may include numerous holes or aperture 110 as will be discussed further below.

Bone plate 20 may be made from metal including but not limited to stainless steel, titanium, composite materials, combinations thereof, and so forth. Bone anchors 120 are known in the art and may be of numerous materials.

Invention 1000 contemplates plate 20, which is generally contoured to adapt to humerus 130 distal end 140 anteromedial aspect of medial condyle 150. The distal end plate30 may be generally curved in the coronal plane as depicted in its distal portion, although Invention 1000 contemplates numerous contouring and or curvature. Invention 1000 also contemplates plate 20 to be contoured at its distal portion in the sagittal plane towards the front at two places as depicted in Figure 6.

Holes or apertures HOC, HOD, and so on proximally (Figure 5) will be a combi-hole pattern which is already in common use. The lower portion of these holes HO C, 110 D, and so on, may be threaded, and angled, to cooperate with corresponding bone anchors 120 with locking threads in the head. A preferred embodiment may be where bone anchors 120 head finish generally flush with bone plate 20 top surface 60. The first two holes 110A and 110B in the plate will only be single-threaded locking holes so that the corresponding screws, 120 A, and 120B will lock in the corresponding directions, wiz already explained in figure 1

Referring once again to figure 5, it is understood that plate 20 has generally a curve 230 wherein plate 20 distal end 30 is generally flush and curved along humerus 130 medial condyle 150. Curve 230 may be generally angled as defined as angle 260 (Figure 5) between Line AA which may generally lay along and parallel with plate 20 upper 50 and middle portion 40 and Line BB, which may generally lay along and parallel with distal end 30 (Figure 5). Angle 260 may generally be 15 degrees although it is contemplated that angle 260 may be greater or smaller.

Figure 6 illustrates another side-view depiction of a preferred embodiment of the invention.it is understood that plate 20 generally has curves 240, and 250 slightly anteriorly along the bottom 70 of the plate in the sagittal plane so that distal end 30 is generally flush along the anteromedial surface of humerus 130 with corresponding angles 270 and 280 respectively. Curve 240 may be generally angled as defined as angle 270 between the line CC which is parallel to the upper 50 and middle 40 portion of the plate 20, and line DD, which may generally lay along and parallel with distal end 30 posterior surface 70. Angle 270 may generally be 23 degrees. Curve 250 may be generally angled as defined as angle 280 between the lines CC which is parallel to the upper 50 and middle 40 portion of the plate 20 and line EE, which may generally lay along and parallel with most distal end 30 along the bottom 70. Angle 280 may generally be 40 degrees. Both the angles 270 and 280 may generally be 23 degrees and 40 degrees, respectively, although it is contemplated that angles 270 and 280 may be greater or smaller.

Figure 7 illustrates a preferred embodiment of the incisions(cuts) on the front view of the arm for the insertion of the invention. Once again, referring to the drawings in general and more specifically to Figure 7, invention 1000 may include a method for utilizing plate 20 in a minimally invasive fashion which may already be a known technique. It may utilize two small incisions(cuts), one in the region of medial condyle 150 to push plate 20 upwards towards the shaft 130 and retrieving the upper end of plate 50 in another incision(cut) in the upper 3rd of the arm 130. Importance may be mentioned of the technique of passing the upper tapered end 55 in close approximation to the bone so that it safely negotiates the neurovascular structures. In practice, plate 20 is contemplated to be used in such a manner that the screws 120D, 120E, and so on may not be filled with screws 110, to avoid injury to neurovascular structures. In essence, plate 20 is contemplated to utilize in such a manner that the distal portion 30 and the proximal portion 50 would be anchored to bone with bone screws 120 leaving the middle portion screw holes 110C, HOD, and so on, empty.

Invention 1000 contemplates plate 20 generally to be positioned on the anteromedial humerus such that first end 30 does not extend past medial condyle 150. Second end 50 may generally be positioned on shaft 220 of humerus 130 and may have a varying length of 90. The middle portion 40 of the plate 20 will be lying underneath the neurovascular structures and may not be filled with screws as decided by the surgeon intra-operatively.

Possible indications may be primary fractures of humerus 130 distal end 140, which can be just above the olecranon fossa 210, and other fractures of the metaphyseal region 135 of the humerus 130. The distinct contemplated advantage of this invention 10 is proper fixation and alignment of very low metaphyseal 135 fractures of humerus 130, with a minimally invasive technique, without potential injury to neurovascular structures.

Figure 8 illustrates a flow chart of a method for utilizing an anteromedial distal humerus locking compression plate in a minimally invasive fashion. At step 202, method 200 includes making two small incisions in a region of a medial condyle and an upper third of an arm.

At step 204, method 200 includes pushing a plate upwards towards a shaft and retrieving an upper end of the plate through the second incision.

At step 206, method 200 includes ensuring the upper tapered end closely approximates a bone to safely negotiate neurovascular structures.

At step 208, method 200 includes using the the plate in a manner that distal and proximal portions are anchored to a bone with bone screws, leaving the middle portion screw holes empty.

In another embodiment, the incisions are made using a surgery kit with numerous sizes of bone plates.

The device(DHAM LCP)is intended to fix fractures of the lower third shaft of the humerus(arm bone) and can be applied in a minimally invasive mode(small cuts) with minimal blood loss, less pain after the operation and minimal scar after healing.

The invention provides a method of manufacturing a plate that is pre-contoured to best fit the contours of the anteromedial (front of the inner side of the arm near the elbow) distal humerus anatomy. The invention takes advantage of the fact that human adult humerus structure and shape are highly similar among the population. Accordingly, plates can be precontoured during manufacture to fit a large proportion of the human adult population. It will be fixed to the bone with locking screws thatgo in a predetermined direction in the bone for which holes would be made by drilling the bone through a guide attached with threads to the plate.

Bone stabilization plates made by a method in accordance with the invention are shaped in three dimensions during manufacturing to require less bending and contouring during surgery to save time, minimize surface irregularities in the installed plates, and reduce metal fatigue due to bending and twisting

It is a further object of the present invention to provide a new plate and method of using the same, which is of a robust design, as well as be easily and efficiently manufactured. This new and improved bone plate system provides some of the advantages of the prior art, while simultaneously overcoming some of the disadvantages normally associated there with the foremost being application in a MIPO mode and pre-contoured design. For a better understanding of the invention, its operating advantages, and the specific objects attained by its uses, reference would be made to the accompanying drawings and descriptive matter in which there are illustrated preferred embodiments of the invention.

Existing plates are straight and need to be contoured during operation to fit the 3D anatomy of the distal humerus which is a time-consuming process. This additional time increases anesthesia requirements and operating room time and increases the potential for infection. The inevitable over-bending and under-bending of plates during efforts to form the plates during surgery creates crimps and other surface imperfections in the plates and it alters their structural integrity due to metal fatigue.

The locking holes for the screws in currently available plates in the market can be damaged during contouring and the screws rely upon the chance to get hold in the risk-free zone of the bone.

Both these above problems can be overcome by our invention which is pre-contoured as per the anatomy of the distal humerus and locking holes are designed in a manner for best purchase in bone in a risk-free area.

The device has a limitation in that certain holes in the plate need to be left without the screws as these screws can perforate important nerves and blood vessels in their path. But the locking mechanism of screws in the holes of the plate providesadequate stability even if some holes are left behind without screws filling them.

This invention would be an alternative fixation device for the treatmentof fractures of the distal third humerus shaft fracture. The unique and specific advantage of this invention is that it can be applied by MIPO(minimally invasive mode) and its pre-contoured design would save operation time.

After biomechanical testing, the invention can be manufactured on an industrial scale and then can be supplied to hospitals and Orthopaedic surgeons who can utilize it for the treatment of distal 3rd fractures of the humerus shaft. The drawings and the forgoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples. Numerous variations, whether explicitly given in the specification or not, such as differences in structure, dimension, and use of material, are possible. The scope of embodiments is at least as broad as given by the following claims.

Benefits, other advantages, and solutions to problems have been described above about specific embodiments. However, the benefits, advantages, solutions to problems, and any component(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature or component of any or all the claims.

Claims

1. Adistal humerus anteromedial locking compression plate (DHAM-LCP) device for treating fractures of a lower third shaft of a humerus bone in adults, said device comprises: a pre-contoured metallic plate (20) made of medical-grade titanium or stainless steel alloy, said pre-contoured metallic plate (20) having a proximal portion, a transitional portion, and a distal portionfor fixation of a humerus shaft and distal humerus; a plurality of holes (110) fabricated at a user-defined distance from said distal portion of saidplate (20) along its entire length, adapted to accommodate plain or threaded screws and configured to accommodate locking screws, non-locking screws, drill guides, and extensions; wherein said plate (20)features at least three curves, one in a side-to-side direction and two curves from a front-to-back direction. The side-to-side curve situated in the distal portion of the plate (30), would have an angulation of 15 degrees. There will be two curves from front to back, both in the distal portion of the plate, with the first and the distal-most being 23 degrees and the second, a little proximal being 40 degrees; and twoanchors (120) in distal-most two holes of said plate (20) go inside a bone only in a user-defined direction by locking a screw head into a screw hole in a particular direction.

2. The device, as claimed in claim 1, wherein said plate (20)has a constant width of 12 mm along its entire length having a lower/ distalend (30), a shaft and or middle (40), anupper/ proximalend (50), atop surface (60), a bottom surface (70), a width (80), a length (90), and a thickness (100), wherein said second end 50 may include a tapered portion 55 generally making second end 50 narrower.

3. The device, as claimed in claim 1, wherein said proximal portion of said plate (50) is designed to fit an anteromedial surface of said humerus shaft(220), whereas said distal portion of saidplate (30)is shaped to match an anteromedial portion of the distal humerus.

4. The device as claimed in claim 1, wherein said the screw holes along the distal portion of the plate (30) is specifically designed to accommodate screws for fixation of the distal humerus, including the medial condyle (150), trochlea (160), and a metaphyseal portion of the humerus (135).

5. The device as claimed in claim 1, wherein said shaft portion 40 of the plate may be essentially straight in the coronal plane in the upper portion with a slight curve in the Sagittal plane in the lower portion to match the natural curve of the distal third humerus bone.

6. The device as claimed in claim 2, wherein said length (90) may be about 12 centimeters such that said length (90) may be shorter or longer, wherein said width (80) may be about 12 mm along a whole length of saidplate (20) except at a flared upper end 55, wherein said thickness (100) may be about 3.5 mm such that said thickness (100) may be greater or lesser.

7. The device as claimed in claim 2, wherein said plate (20) is to be positioned on an anteromedial humerus such that said lower/ distalend (30) does not extend past medial condyle (150) and said second end (50) may be positioned on shaft (220) of humerus (130) and may have a varying length (90), wherein said middle portion (40) of saidplate (20) lying underneath a neurovascular structures and not be filled with screws as decided by a surgeon intra-operatively.

8. The device as claimed in claim 2, wherein said plate (20) with apertures (110A), (HOB), (HOC), and (110D) proximally for generally positioning bone anchors (120A), (120B), (120C), and (120D) generally anteromedial aspect of distal aspect (150) and shaft (220), said bone anchors (120) in said proximal portion while last two anchors (120 A) and (120B) have fixed pre-defined angle of insertion in corresponding screw holes (110A) and (HOB).

9. A method for utilizing an anteromedial distal humerus locking compression plate (20) of claim 1 in a minimally invasive fashion, said method comprises: making two small incisions in a region of a medial condyle and an upper third of an arm; pushing a plate upwards towards a shaft and retrieving an upper end of said plate through said second incision; ensuring said upper tapered end closely approximates a bone to safely negotiate neurovascular structures; and using said plate in a manner that distal and proximal portions are anchored to a bone with bone screws, leaving middle portion screw holes empty.

10. The method as claimed in claim 9, wherein said incisions are made using a surgery kit with numerous sizes of bone plate.