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  • 专利说明
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    • 专利摘要:
    orthopedic clamp device. orthopedic structure that includes a method for forming a threaded fastener with thread geometry and leading edge geometry that provides greater accuracy during installation. specifically, the thread pitch and tooth profiles are independently variable. a forward portion of the fastener advances bone fragments ahead of the fastener to reduce insertion torque and prevent the fragments from becoming located in the upstream tooth profile for better retention.
    公开号:BR112015003930B1
    申请号:R112015003930-8
    申请日:2013-08-22
    公开日:2021-09-08
    发明作者:Gary Jack Reed
    申请人:Rtg Scientific, Llc；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention is generally directed to devices used by surgeons primarily to implant bone and to repair fractures. More specifically, the present invention includes a fastener capable of being rotated about an axis that is adapted, among other things, to resist disengagement and reduce insertion torque, thus providing both tactile feedback to the surgeon and minimizing trauma in place of attachment with the control of heat build-up due to friction. The fastener reduces insertion (cut) pressure and increases fastener control, thereby minimizing problems associated with misalignment. BACKGROUND OF THE INVENTION
    [002] Surgical procedures that involve fasteners in the skeletal structure currently suffer from several weaknesses. One is the inability to accurately orient the fastener during insertion to prevent the fastener from getting lost along the way. Bone interiors have a sponge-like (spongy) texture. Even with a pre-drilled pilot hole, fasteners still often deviate from the pilot hole axis, thus making it difficult to seat the fastener at its distal end with another means.
    [003] Another weakness is the failure to provide a reliable thread portion that engages the patient's bone in order to delay its detachment. Bone is a remarkable structure that varies in both hardness and elasticity as a function of both age and location. Loads on the fastener have to accommodate not only these forces, but also the dynamics of forces generated by the patient in daily activities.
    [004] Sawtooth thread is currently the industry standard. Unfortunately, sawtooth threads are suitable for use only when load forces on the fastener are applied in one direction. (Bhandari, Design of Machine Elements (2007), page 204). When loading forces are multidirectional or non-unidirectional and axial, failures can occur. One manifestation of sawtooth thread failure is "fixation" where the fastener works in the bone and widens the hole in which the fastener is located.
    [005] Yet another weakness related to the high insertion torque is the impossibility of inserting the screw through bone fragments without it getting stuck in the fragment and without it rotating with the screw causing significant trauma to the soft tissues and a failed fixation of the fragment.
    [006] In an attempt to compensate for the multiple problems of sawtooth threads, it is common practice to design the sawtooth thread profile to increase retention with greater friction. Increased friction results in elevated temperatures during insertion, potentially damaging bone tissue. A temperature variation greater than 47 degrees Celsius (116 degrees Fahrenheit) at the insertion site causes osteonecrosis that cannot be repaired and that the body cannot repair. Even worse, the excess heat compromises the fastener's ability to stay in place as the bone has faded away at the screw-thread interface. As a result, some procedures rely on liquid cooling in place during the drill/insert procedure, but even so, the process generates so much heat that the heat generating tool may feel too hot to the touch because the liquid cooling is merely topical.
    [007] Since the only variables (thread pitch, crest and root diameters) in the sawtooth thread design are interrelated, improved retention increases friction and insertion torque, resulting in heat generation and impairing the surgeon's ability to significantly sense fastener insertion torque. This still leaves the fundamental problem of the screw's inability to withstand unaddressed multidirectional forces, while creating many new problems.
    [008] The surgeon will have no tactile feedback when inserting the fastener. The sawtooth fastener is more difficult to set in motion and is prone to wear, especially when used in conjunction with a board. The sawtooth thread induces a radial force, perpendicular to the long axis of the fastener, which increases the probability that the bone will break or crack, making the procedure even more difficult, if not impossible. The sawtooth thread fastener can wander during insertion, making its seating with a means at the distal end of the fastener a recurring problem. Pilot hole drift often results in cutting new threads at an unintentional location or pilot hole wear, which delays re-establishment and effectively induces trauma; and, when there is a temperature variation above 47 degrees Celsius (116 degrees Fahrenheit), this can also cause osteonecrosis of the adjacent bone.
    [009] The thread geometry of the present invention minimizes insertion force. This allows for tactile feedback from the surgeon and reduces the effort required to unfold the fastener. This, in conjunction with a forward chip feeder, a centering pilot, and improved thread cutting features keep friction low, the fastener aligned and strayed from the preferred path.
    [0010] The distal end of many fasteners include a raised area (flute) designed to help cut through bone, defining a "self-tapping" fastener. The self-threading of the sawtooth thread fastener features a flute that is straight or is at least nearly in alignment with the axis of the screw. That is, as the fastener advances, the cut edges send the bone fragments to the fastener head which is in the path of the helical threads. This bone debris accumulates along the threaded teeth and increases insertion torque and friction which therefore generates additional heat. The debris also makes insertion of the fastener difficult and provides a poor interface with the bone and the fastener.
    [0011] In the present invention, the cut fragments are threaded away from the cutting edges and are fed into the pre-drilled pilot hole in front of the fastener because the flute is "left" on a right-hand threaded screw. That is, as the fastener advances, the flute forces the fragments forward into the pilot hole in front of the screw. This results in a precise clearance between the fastener and the portion of bone being formed as "bone teeth" (that portion that engages the threaded fastener). The interface between the bone and the fastener is therefore substantially free of debris and provides healthier bone tissue adjacent to the fastener to prevent further trauma to the bone.
    [0012] Another problem associated with sawtooth type threads is that the area between the fastener threads is the only place of attachment in the bone, and because of the design limitations associated with it, this location is difficult to be optimized. Alternatively, fastener metal is orders of magnitude stronger than remaining bone; thus, when failure occurs, there will always be trauma to the bone.
    [0013] The present invention maximizes the bone that is engaged while minimizing the fastener thread, something impossible to do with a sawtooth thread and other common threads and common manufacturing processes. The result is less trauma to the bone and less bone removed to increase bone strength to better retain the fastener.
    [0014] This invention discards the conventional design and manufacturing processes in the search for new and desirable functions that can be obtained from the thread profile.
    [0015] Until now, manufacturers have adopted a simple and very fast manufacturing process that produces screws that do not perform any better than common wood screws. BRIEF SUMMARY OF THE INVENTION
    [0016] The present invention addresses various skeletal components with fasteners in ways heretofore unfeasible with an improved thread pattern that provides greater retention of the bone structure and minimal damage to bone adjacent to the fastener.
    [0017] This invention produces a bone screw thread design that can be modified in many independent ways to produce different capacities and functions that can contribute to better grip, greater tensile strength, lower cutting and insertion pressure than it reduces the temperature of the site and causes less damage to the bone in the process. These features provide a better feel to the surgeon installing screws to prevent frayed threads, better clamping force, better clamping, and ultimately a shorter healing time.
    [0018] A new manufacturing process is described that uses single-point threading in conjunction with multi-shape cutting tools with different shapes and following different paths to create thread features formed by successive independently programmable cutting movements, each distinct from the other. This means that the tooth height, thickness and spacing can each now be modified independently to produce different characteristics and capabilities to greatly improve both the procedure, when the screw is installed into the bone, and the screw performance. on site.
    [0019] While the method being described forms threads of greater complexity in the process, in a production scenario it is only possible because of CNC machine tools and the ability to program sequential independent cutting movements to create unique features unknown in the prior technique.
    [0020] The fixation of the bone is very complicated because ruptures are found in an infinite variety of shapes and locations. Fasteners embedded in bone need to minimize trauma and bone removal while minimizing retention in a dynamic environment. The benefits derived from these new screw designs and a method to produce them will be very significant for industry and patients. OBJECTIVES OF THE INVENTION
    [0021] Consequently, the main objective of the present invention is to provide an orthopedic fastener structure and a method of manufacturing the fastener.
    [0022] A further objective of the present invention is to provide an improved threaded portion for the same.
    [0023] A further objective of the present invention is to provide an improved threaded portion that minimizes bone trauma, resists failure and is easy to install.
    [0024] A further objective of the present invention is to provide a fastener that can accommodate a plurality of different angles of attack when addressing a skeleton structure.
    [0025] Seen from a vantage point, an objective of the present invention is to provide an orthopedic fastener formed by independently modifying the height, thickness and spacing of the bone, thus changing the characteristics and capabilities of the fastener.
    [0026] Seen from another vantage point, an objective of the present invention is to provide an orthopedic fastener formed by independently modifying the height, thickness and spacing of the tooth, thus changing the characteristics and capabilities of said fastener, by means of than the pitch and major and minor tooth thread diameters are independently variable to facilitate the association of fastener thread profiles with corresponding bone tooth profiles as a function of bone density and fastener deployment location for improve the fastener's support point and increase the resistance to pulling forces.
    [0027] Seen from the above vantage point, an object of the present invention is to provide a fastener that additionally includes the formation of a fragment cutting flute at a distal end thereof, said fragment cutting flute having edges of cutting edges defining a cutting thread pattern disposed on said distal end and spiraling helically in an opposite direction from a thread pattern disposed on the remainder of the fastener, said thread pattern disposed on said remainder of the fastener defining a pattern of substantially non-cut interlock thread, whereby said cutting flute forms the interlock thread pattern in the bone, thus reducing friction with fastener insertion and minimizing heat build-up while provides greater sensitivity during fastener installation, reducing installation torque and possible misalignment that would otherwise cause unneccessary removal. bone stress and thread wear while resisting breakage of loose bone fragments during installation.
    [0028] Seen from the above vantage point, an object of the present invention is to provide an additionally formed fastener with the arrangement of the interlocking thread pattern spirally along the fastener, interrupted by a substantially cylindrical fastener axis, such as so that said fastener axis defines a cylindrical wall that is spiraled along the length of said fastener, and interrupted by said interlocking thread pattern, whereby said interlocking pattern retards fastener attachment and minimizes radial forces while resisting multidirectional forces and bending moments that would otherwise cause the fastener to lift.
    [0029] Seen from the above vantage point, an object of the present invention is to provide a fastener that additionally forms a bearing surface adjacent to a proximal end of said fastener, defining an impediment to further advancement of the fastener and a means for induce the fixation of said brace in an orthopedic environment.
    [0030] Viewed from a previous vantage point, an object of the present invention is to provide a fastener that additionally forms an interference fit adjacent to a proximal end of said fastener, defining an impediment to further advancement of the fastener and a means to induce the fixation of said fastener in an orthopedic environment.
    [0031] Another advantageous point contemplates an orthopedic fastener, which comprises, in combination, an axle having a proximal end provided with a means for advancing said fastener and a means for preventing the advance of the fastener, said axle having a thread pattern providing an interlocking means wrapped around said axis, said thread pattern interrupted by intermediate walls of said axis, a threading means at a distal end of said axis, said threading means having a pattern of opposite thread from said thread pattern having said interlocking means, and a pilot at said distal end of said shaft adjacent to said threading means, said threading means including a means for advancing bone fragments away from said catch.
    [0032] Another vantage point contemplates a process for forming an orthopedic fastener, the steps including: forming an interlock thread on a substantially cylindrical rod of the orthopedic grade substrate, forming a first and second facet of said interlock thread on said structure with a first cutting tool while inducing relative rotation between the substrate and the first cutting tool, forming a third facet on said substrate with a second cutting tool while still inducing rotation, and forming fourth and fifth facets on said substrate with a third cutting tool while inducing counterrotation. BRIEF DESCRIPTION OF THE DRAWINGS
    [0033] These and other objectives will become evident when considering the following detailed specification when taken in conjunction with the figures in the attached drawing.
    [0034] Figure 1 is a side view of the fastener.
    [0035] Figure 2 is a sectional view of a portion of the fastener.
    [0036] Figure 3 is an additional sectional view of the fastener geometry, detailing the thread relationships.
    [0037] Figure 4 shows the fastener in perspective.
    [0038] Figure 5 is a view of a first step in forming the thread.
    [0039] Figure 6 is a view of a second step in forming the thread.
    [0040] Figure 7 is a view of a third step in forming the thread.
    [0041] Figure 8 details the front end of the fastener that initiates insertion.
    [0042] Figure 9 illustrates the amount of bone tissue that is lost with a conventional sawtooth thread, as compared to the present invention, excluding the fact that the present invention does not require uniform spacing of adjacent threads (step) , as in a sawtooth thread. Examples of increasing the thread pitch while maintaining the same thread height are also shown.
    [0043] Figure 10 is a view of the distal end of the fastener, showing details of the pilot and left fragment dispersion flute and improved self-threading characteristics along with an eccentric relief starting at the front cutting edge of each thread formed by a first left flute.
    [0044] Figure 11 illustrates force vectors, one of which will be a reaction force when the fastener has reached the compressive tightening moment.
    [0045] Figure 12 shows a portion of a cutting tool that forms an aspect of the cutting threads in the flute.
    [0046] Figure 13 shows an end view of the cutter and its leading edge in the form of a claw formed by the tool of Figure 12.
    [0047] Figure 14 is a side view of the cutter formed by the tool in Figure 12.
    [0048] Figure 15 is an end perspective of a double-threaded thread fastener.
    [0049] Figure 16 is an end view of the double thrust thread cutting edges defined by the flutes. DESCRIPTION OF PREFERRED EMBODIMENTS
    [0050] In considering the drawings, where similar reference numerals indicate similar parts throughout the various figures of the drawing, reference numeral 100 is directed to the orthopedic stabilization brace according to the present invention.
    [0051] The features of the screw threads in Figure 1 include: the head 2 (defining a proximal end) of the screw is comprised of spokes 9 and 10 that converge at the apex 11 to form the outer diameter of the head 2. The head 2 may include a bottom wall 6 defining a support surface, so that when the fastener 10 is fully installed, the support surface 6 rests against a support surface (e.g., the patient's body or plate) and induce the compressive load 5 shown in Figure 11. As load 5 is induced, centering points 36, Figure 11, of screw tooth 24 are loaded against lower centering points 37 of bone teeth 25, which prevents internal or external radial forces 3 of the screw shaft 16. Likewise, the load vector 1 of Figure 11 includes a screw centering point 38 against the bone centering point 39. If the fastener is countersunk, the shaft 11 diameter of the fastener 100 will approach the larger thread diameter (ridge) 17 and the compressive load 5 will then be caused by the interference fit which has a thread portion immediately adjacent to the head 2.
    [0052] More specifically, the last turn of the thread 12 (the closest head 2) has both a different pitch and/or tooth thickness that provides a resistive fixation. Up to this point of support, the fastener has a substantially free rotation due to the low friction geometry. This provides tactile feedback to the surgeon. Straight threads 12 are helically wound along axis 13 to produce the thread pitch. The distal end 4 of the screw features a pilot 59 which incorporates fragment dispersion flutes 55 having a left spiral orientation.
    [0053] Figure 4 shows the internal Hex drive socket35 at the proximal end of the screw. Figure 2 represents a cross section 9 of the threaded portion of the screw shaft with a shaft 16 passing through the shaft core.
    [0054] The thread 24 extends away from the thread root 18 (outside of shaft 13) defining the larger thread diameter 17. The bone tooth 25 is formed by the limits of the thread root 18, by the screw thread tooth 24 and by screw thread 26. The root thread 18 (outside of shaft 13) defines a substantially continuous cylindrical wall, which is helically spiraled between the shaft threads and interrupted only by the helically wound threads 12.
    [0055] The external bulge of the screw threads 32 (Figure 3) and the thickness of the screw threads 30 coupled with the improved cutting edges of the screw teeth 51 (Figures 8 and 10) created by the left concave spiral fragment dispersion flute 55 (Figures 1, 4, 8 and 10) determine the cutting and insertion torque of the screw. This is an important and significant improvement as it provides the surgeon with a desired tactile interpretation of the bone interface. It also helps the surgeon determine how tight the screw is and how much load is actually being applied for compression. Current technologies require a lot of torque to install a fastener that makes the surgeon barely able to tell what's really going on. This often results in worn threads or loose screws.
    [0056] Another key feature of this new thread profile in Figure 3 is the method of fabrication with the options to easily change the external protrusion 32 of the screw thread teeth, the spacing 34 between adjacent teeth that determines the dimension ("volume ") of the bone tooth 25, and the thickness 30 of the screw thread teeth.
    [0057] The dimension (volume) of the bone tooth 25 is a very important point because the metal screw thread is significantly stronger than bone. With the ability to create a more equal balance of strength between the two, it is now possible to provide a screw-bone interface that can make a much better and more stable grip on the bone.
    [0058] By increasing the screw thread protrusion 32, it is possible to produce a screw thread that can have a greater support point in less dense bone. By reducing the bone tooth 34 width of the bone tooth 25, it is possible to create a smaller step to a better bone fulcrum with a very thin cortical wall, while at the same time increasing the dimensions of the tooth bone. spongy ones that require wider bone teeth 25 and a larger external protrusion of bone teeth 32. options.
    [0059] The step shown in Figure 5 for this new method of manufacturing multiple cutting tools for material removal teaches that a specially shaped cutting tool 40 creates screw thread facets 42, 44, and root 46.
    [0060] The step shown in Figure 6 for this new method of manufacturing multiple cutting tools for material removal teaches that a specially shaped cutting tool 41 creates screw thread facets 43, and additional root 45.
    [0061] The step shown in Figure 7 for this new method of manufacturing multiple cutting tools for material removal teaches that a specially shaped cutting tool 47 creates screw thread facets 48, and additional root 49. The steps in Figures 5 and 6 occur with relative rotation in one direction; the step in Figure 7 is counter-rotated.
    [0062] The importance of the roots 45, 46 and 49 is that these surfaces define a substantially wide cylindrical wall that is helically spiraled along the fastener, interrupted only by the interlocking teeth, so that bending forces experienced by the fastener are distributed along these roots and therefore also along the bone teeth in tangential seating with it to prevent any movement because of the larger surface area which is devoid of any sharp surfaces that would otherwise define pressure points as in prior technique.
    [0063] Figure 9 illustrates the benefits of this three-step cutting process when compared to a sawtooth thread. As shown, two thread profiles are shown with their pitches in settlement. A sawtooth thread is superimposed over a thread of the present invention. As shown, the sawtooth thread removes at least one-third more bone in this representation, but it should be noted that the thickness 30 (Figure 3) of the thread of the present invention could be reduced to the thickness of a thin blade, when appropriate material has been chosen for the fastener. When thickness 30 has been optimized (minimized), a maximum bone tooth volume is available for maximum grip and minimal trauma while reducing frictional and insertion force.
    [0064] Yet another significant feature of this invention is the mechanical interlocking capability of this thread profile. In essence, the bone thread tine 25 is interlocked between the sawtooth threads 24 and 26. This is illustrated in Figures 2 and 11. Reaction forces, which respond to the load 5 induced by tightening, are distributed along the length. of the various facets/flanks of the fastener. As shown, forces are centered, flanks of screws are interlocked with the surfaces of bone teeth 25, and centering points 36, 37, 38, 39 at the juncture of the flanks cooperate to prevent excessive stress and resist dispersion in axial load or torsional loading. Specifically, flanks 19 and 20, 21 and 22, 22 and 23 operate in pairs such that the intersection of the pairs defines centering points for load distribution and force equalization.
    [0065] It is noted that the threaded tooth face 20 is at a smaller angle from the axis 16 than the screw thread facet 21. This means that the bone screw tooth 25 is trapped "inside" ( between apex 36 (Figure 11) formed at the junction of facet 22 and 23 on one side, and thread root 18 and screw thread faces 20 on the other side). This produces an instantaneous mechanical interlock between fastener screw threads 24 and 26 along thread 12, and bone thread tooth 25. The importance of this feature has a far-reaching value. In bone, it is best to produce an interface that is neither radially dispersed nor radially extracted when the screw is tightened to reduce trauma to the bone.
    [0066] Ordinary bone screw threads create harmful compressive loads that can crack bone or at least compress live bone excessively adding trauma. In the present invention, these problems are solved. Here, the relationship of the facets of teeth (flanks) 19 and 20 can be "adjusted" (dimensionally modified) with respect to facets (flanks) 21, 22 and 23 to change the thickness of the tooth of fastener 30 and the separation between the teeth adjacent bones via modification of the bone tooth gap 34, for example, to provide maximum bone engagement and optimize compression pressure for trapped bone located between the teeth of the fastener.
    [0067] This invention with its improved cutting edges, chip removal, a reduced tooth width and less bone removed produces new bone interface characteristics while providing the surgeon with the best possible feel during the initial threading and torque sequence.
    [0068] Figures 8 and 10 show the pilot 59 with the concave spiral fragment-dispersing flute 55 which is angled from the axis of the screw 100 by approximately 45° (reference numeral 52). The fragment dispersion flute has a portion that opens through the outer diameter of the pilot 59 and extends in a left helical transition a short distance (1 or more threads) towards the proximal end of the screw. The chip dispersing flute smoothly transitions to axis 13 and threads 12. Effective chip cutting is caused by sharp front cutting edges 51 formed by the left helical chip dispensing flute 55 and having slightly blunt rear cutting edges 53 The concave radius of the flute 55 thus produces a sharp leading cutting edge 51 at the intersection of the threads 12 and the flute 55 at the major diameter of the threads 12. The eccentric radial relief edges 62 are combined with the sharp edges 51 to approximate each other. a claw-like contour where the larger diameter decreases as it moves away from the edges 51 to provide leading edges that can easily cut the bone which produces fragments that are threaded away from the cut edges and that transition out of the groove of concave fragments dispersion. Said eccentric relief gradually reduces the height of the threads 12 until it is interrupted by a next left flute where, with the eccentric relief, it starts again at the larger diameter of the next helical thread 12, as it continues on the opposite side of the second left flute and ends at a lower height, as it ends again on the left side of the next flute.
    [0069] Figure 12 reveals how the radial eccentric relief 62 is formed by a special cutter 200 that rotates to the right as the screw is rotated to the left as it slowly moves downward 77 to form eccentric reliefs 62. The cutting end of the cutter is formed at an angle 76 to cut a slight taper in the outside diameter of the threads 12 extending from the distal end of the threads upward toward the proximal end to match the length of the fragment dispersing flute 55.
    [0070] This is illustrated in Figure 13 as a cross section of the "claw" thread cutting profile produced with the combination of the flute 55 which creates the sharp cutting tip 51 and the re-levoeccentric 52 with rotation of the rotary cutter 200 as it moves in a downward direction 77 until it reaches the trailing edge of the next flute 55. At this point, the cutter 200 moves up to begin the same process again on the leading edges of the next side of the flute 55 and continuing this process until the cutter has completed a 360° rotation and all distal threads have been treated by cutter 200 with eccentric radial reliefs 62.
    [0071] These features are combined to clean cut threads and move the fragments along the fragment path 57 by pushing them forward through the drilled pilot hole in front of the lead screw as it is helically rotated into the bone. Leading edge 61 of flute 55 and root 13 transition produces a fine fit within the inner diameter of the drilled pilot hole to provide a positive scraping and debris removal action as screw 100 rotates within the drilled pilot hole . This scraping action forces the debris down and out of the pilot's precision fit into the drilled hole. The benefit here is that the leading edges 51 cause the fragments to be threaded forward and follow the contour of the flute 55 forward, and away from the end of the fragment path 57 away from the path of the lead threads.
    [0072] Alternatively, as the fastener is inserted clockwise CW (Figures 4, 8 and 10), the front cutting edges 51 progressively trim thin thin strips of bone, advancing them forward and pushed by the front edge 61 into the direction 57. This creates a genuine self-tapping screw and also prevents fragments from being dragged into the lead screw threads and into the bone. This results in much lower cutting pressure, cleaner threads and less damage to the bone. (If the fragments cannot get out of the way, they will be dragged into the threads' path and will be crushed into the surrounding bone. If this happens, the trapped fragments can give rise to an inflammation process resulting in the immune system attacking the fragments as bodies. strangers with eventual absorption, producing voids near the threads, eventually resulting in loosening of the screw threads. 12.) Figure 16 shows a cutter and pilot for a double-threaded double-thread fastener.
    The pilot 59 has a substantially circular planar distal end 4 interrupted by portions of the fragment dispensing flutes 55 shown in the drawings. More or less shred dispensing flutes 55 may be provided, provided they are symmetrically oriented along the periphery. A marginal periphery 60 provides a rounded transition between the planar distal end 4 and the cylindrical axis 13. This rounded transition forces fastener 100 to remain in the pre-drilled pilot hole, thus ensuring fastener 100 seating with other surgical means ( such as a plate) at the distal end of the fastener.
    [0074] In use, preferably a pilot hole is pre-drilled and fastener 100 is oriented thereon. The radius 60 of the pilot 59 is nested within the pre-drilled pilot hole. Advancing the fastener with clockwise rotation (CW) causes the fragment dispensing flutes 55 and their front (left) cutting edges 51 to incrementally trim bone fragments away from the fastener, with the leading edge 61 pushing the fragments forward to the concavity and forward to the pre-drilled hole along path 57, after they have been eliminated by the rear cutting edges 53. The bone is therefore threaded in accordance with the tooth profile of the fastener. As the fastener advances into the bone, the bone teeth 25 provide positive engagement with the fastener 100 without noticeable friction (damaging heat build-up) or unwanted radial forces experienced by the surgeon who - unlike the prior art - can advance the fastener with very little effort.
    [0075] This gives the surgeon accurate information about the progress of the procedure. The rounded wall 60 on the pilot accurately tracks the pre-drilled hole without damaging wandering and trauma to adjacent bone. The fastener threads are concurrently self-locking with the bone teeth until the fastener approaches full implantation. Then, the bearing surface 6 at the bottom of the fastener head contacts the cortical bone on the outer periphery of the pre-drilled hole producing vector 5, Figure 11.
    [0076] This contact induces a change in force that is noticeable to the surgeon, unlike the prior technique. The surgeon thus has a better "feel" to detect and adjust compression/torque in a more beneficial way for the procedure. As mentioned above, there will be even improved tactile feedback when the fastener does not have a head but is countersunk instead. In addition, an interference thread 71 adjacent to the proximal end 6 provides additional feedback and retention. This is achieved by increasing the width 30 of one or more threaded teeth near the proximal end 6 which creates a clamping load on the bone tooth 25 (with the decrease in dimension 34) against the bone teeth 25 that have been formed. by thread cutting characteristics at the distal end of the screw.
    [0077] An alternative (or supplement to this interference thread) would be to change (increase) the larger diameter of the thread near the proximal end 73 while maintaining the original height 32 at the distal end 72, which provides an interference fit at a different way. This (tapering) is recognized by reference line 74 and provides greater drag along the larger diameter of the threads as the screw is advanced into the bone. In addition, the single-head fastener can benefit from either or both types of interference fit, if desired.
    [0078] Additionally, in the case of lateral loading ("clamping") force, the vectors 3, Figure 11, are pressed by the interlocking capability of the screw threads 24 and 26 which are instantaneously and mechanically interlocked with the bone teeth 25. Unlike the prior art, the loading screw 100 on one side or the other does not create a gap between the screw and the bone on the opposite side. This is commonly referred to as "fixation" and often results in screw-to-bone interface failure.
    [0079] A somewhat similar issue will occur when a bending moment 14 is applied to screw 100, where the resulting force causes a similar screw produced with sawtooth or type V threads to yield to force on the root diameter ( groove) between two threads. When yielding occurs, the root of the thread will act as a radial groove around the circumference of the bolt and the total load will be focused on the weakest point (a single thread groove) near the apex of the bending member resulting in core failure of the screw. Unlike this weakness found in all other thread forms, the present invention features thread roots that are cylindrical in shape and lack thread grooves, thus dispersing the load of a bending moment evenly along the screw axis. This provides a more durable and reliable bolt resistant to bending.
    [0080] Figures 15 and 16 teach the use of a double-thread pattern. A first interlock thread 110 is spiraled along the cylindrical axis as before, but a second interlock thread 120 is also spiraled along axis 13. It is noted that the cutting edges 51 and other details of Figures 8 and 10 appear here, as well as pilot 59. Thus, adjacent threads of the first interlocking thread 110 have a second thread 120 interposed between them. This means that the pitch of this fastener is twice that of the previously described fastener, which results in faster insertion (axial feed) of the double thread design. When time is of the essence, this will be an important feature, and operations such as this will be better completed conveniently for many reasons, such as asepsis, increased productivity and minimal patient anesthesia time.
    [0081] Furthermore, having described the invention, it should be evident that numerous structural modifications and adaptations may be resorted to without departing from the scope and legitimate meaning of the present invention, as shown above and as described below in the claims.
    权利要求:
    Claims (1)
    [0001]
    1. Orthopedic fastener (100), characterized in that it is formed by: independently modifying the height (32), thickness (30) and tooth spacing, thus changing the characteristics and capabilities of said fastener, whereby the pitch and major (17) and minor tooth thread diameters are independently variable to facilitate association of fastener thread profiles with corresponding bone tooth profiles as a function of bone density and fastener deployment location for improve the fastener's support point and increase the resistance to pulling forces; forming a conical spiral fragment cutting flute (55) at a distal end (4) thereof, said fragment cutting flute (55) having front cutting edges (51) defining a cutting thread pattern disposed on the said distal end (4) and which are helically spiraled in an opposite direction from a thread pattern (12) disposed on a remainder of the fastener, said thread pattern (12) disposed on said remainder of the fastener (100) defining a substantially non-cut interlocking thread pattern, whereby said cutting flute (55) is configured to form the interlocking thread pattern in the bone, thus reducing friction when inserting the fastener and minimizing the formation of heat while providing greater sensitivity during fastener installation, reducing installation torque; arranging the interlocking thread pattern spirally along the fastener, interrupted by a substantially cylindrical fastener axis such that said fastener axis (13) defines a cylindrical wall that is spiraled along a length of said fastener ( 100) and interrupted by said interlocking thread pattern, whereby said interlocking pattern and shaft (13) are configured to retard fastening fastener (100) and minimize radial forces while resisting the forces multidirectional and to bending moments that would otherwise cause the fastener to lift; providing a bearing surface (6) adjacent to a proximal end of said fastener (100), defining an impediment to further advancement of the fastener and means for inducing fixation of said fastener in an orthopedic environment, and forming an adjacent interference fit to a proximal end of said fastener, defining an impediment to further advancement of the fastener (100) and means for inducing fixation of the fastener in an orthopedic environment.
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    US10085782B2|2018-10-02|Bone screw
    AU2013266015B2|2017-10-19|Bone fixation device
    EP2373237B1|2013-06-05|Angulated locking plate/screw interface
    EP2401515B1|2015-12-02|Flexible screw
    JP5859965B2|2016-02-16|Components for guided threading of bone
    US8419779B2|2013-04-16|Systematic displacement bone screw
    WO2007016305A2|2007-02-08|Thread on a bone screw
    AU2021106958A4|2021-11-25|A bone fixation system and a plate therefor
    同族专利:
    公开号 | 公开日
    EP2887897B1|2018-07-18|
    US9901379B2|2018-02-27|
    AU2018200716A1|2018-02-22|
    BR112015003930A2|2017-07-04|
    JP2015526201A|2015-09-10|
    HK1210400A1|2016-04-22|
    CA2882980A1|2014-02-27|
    CN104717933A|2015-06-17|
    ES2691275T8|2019-05-22|
    DK2887897T3|2018-11-05|
    AU2013305674A1|2015-03-12|
    EP2887897A4|2016-07-20|
    US20140058460A1|2014-02-27|
    CA2882980C|2021-01-26|
    EP2887897A1|2015-07-01|
    WO2014031884A1|2014-02-27|
    CN109009391B|2022-02-22|
    CN104717933B|2018-04-10|
    ES2691275T3|2018-11-26|
    CN109009391A|2018-12-18|
    AU2013305674B2|2017-11-23|
    JP6326415B2|2018-05-16|
    AU2018200716B2|2019-07-18|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2018-12-18| B25A| Requested transfer of rights approved|Owner name: NSPIRED IDEAS, LLC (US) |
    2019-01-08| B25A| Requested transfer of rights approved|Owner name: RTG SCIENTIFIC, INC. (US) |
    2019-01-29| B25D| Requested change of name of applicant approved|Owner name: RTG SCIENTIFIC, LLC (US) |
    2019-12-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-07-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-09-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/573,128|US9901379B2|2012-08-24|2012-08-24|Orthopedic fastener device|
    US13/573,128|2012-08-24|
    PCT/US2013/056248|WO2014031884A1|2012-08-24|2013-08-22|Orthopedic fastener device|
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