The disclosed invention relates in general to orthopedic and dental surgically implanted devices, and in particular to implantable devices which use a plurality of non-threaded anchors with an implant or plate to compress and join boney structures.
Over a hundred years ago surgeons determined that a combination of screws and plates worked as a method of internal fixation of two or more bone structures. In time surgeons empirically learned that placing two or more bones in mechanical compression greatly improved the speed and quality of bone healing. Mechanical compression was then rendered through external devices and internally fixated with the screw plate device.
Many believe that localized bone compression is the orthopaedic standard for bone healing. Current art uses plates with dedicated screw channels or directive apertures that determine the range of screw angulation and the resultant course of the screw's trajectory.
In many orthopedic related procedures, however, such as spinal, sternal chest closure, dental, and numerous orthopedic reconstructions, plates and screws have not been found to follow compressive bone healing principals. Instead, the screw plate configurations stabilize the boney structures, but do not typically compress the bone structures together. Furthermore, threaded anchors such as screws have many disadvantages, including the tendency to back out of a boney structure over time.
Therefore, what is needed is a novel plate anchor system that consistently achieves bone compression or distraction of two boney structures.
In response to these and other problems, in one embodiment, there is a system that includes non-threaded anchors that follow a trajectory into a boney structure and then a non-threaded head of the anchor interacts with the aperture features in an implant to cause the head of the anchor to move transversely which can cause compression or distraction of boney structures coupled to the anchors.
These and other features, and advantages, will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings. It is important to note the drawings are not intended to represent the only aspect of the invention.
For the purposes of promoting an understanding of the principles of the present inventions, reference will now be made to the embodiments, or examples, 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. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the inventions as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
When directions, such as upper, lower, top, bottom, clockwise, counter-clockwise, are discussed in this disclosure, such directions are meant to only supply reference directions for the illustrated figures and for orientation of components in respect to each other or to illustrate the figures. The directions should not be read to imply actual directions used in any resulting invention or actual use. Under no circumstances, should such directions be read to limit or impart any meaning into the claims.
Anchors:
Turning now to
In certain embodiments, a proximal end 116 of the anchor 100 contains an engagement surface 118 that is angled with respect to the normal direction 110 of center axis 106. In certain embodiments, the engagement surface 118 may have engagement features, such as aperture 120 for engaging with various embodiments of insertion instruments. In the illustrative embodiment, the longitudinal axis of the aperture 120 may be parallel with respect to the center axis 106.
As can be best seen in
Although the anchor 100 as illustrated and discussed above uses a tapering horseshoe cross-sectional shape for the body portion 104, any cross-sectional shape could be used and still be within the inventive aspects of the present invention. Such shapes include triangular, diamond, rectangular, circular or equilateral polygon cross-sectional shapes or a combination thereof. For instance, a triangular cross-sectional shape could be used on the body portion 104 while the head portion 102 may be largely circular in cross-sectional shape. If such shapes are used, generally the body portion will taper down from the head portion 102 to the distal end 122. In other words, the cross sectional areas of the body portion 104 will decrease as the distal end is approached.
In certain embodiments, the anchors discussed above may be fabricated from any number of biocompatible implantable materials, including but not limited to Titanium Alloys (Ti 6Al4V ELI, for example), commercially pure titanium, Chromium Cobalt (Cr—Co) and/or stainless steels. In yet other embodiments, the anchors may also be manufactured from polymer, including Carbon Fiber Reinforced Polymer (“CFRP”) with a high carbon mass percentage. Furthermore in some embodiments, as explained below, the anchors may be formed using a shape memory alloy, such as Nitinol®.
An Embodiment of an Implant:
In the illustrated embodiment of
In certain embodiments, the end portions 204a and 204b have apertures 210a and 210b defined therethrough for accepting a non-threaded anchor, such as anchor 100 described above. In certain embodiments, the apertures 210a and 210b have curved engaging surfaces 212a and 212b defined therein which are sized to receive and engage a surface of the non-threaded anchor 100. In certain embodiments, the interaction of the inwardly sloped engaging surfaces 212a and 212b with the longitudinal shape or geometry of the elongated body portion 104 of non-threaded anchor 100 defines an initial insertion trajectory for the non-threaded anchor. For purposes of this disclosure the “initial trajectory” is the path of movement of the elongated body portion 104 of an anchor 100 starting when the elongated body portion 104 is first introduced into the aperture (e.g. either aperture 210a or 210b of
A Method of Use:
In
Similarly,
Simultaneously, a second non-torsional force continues to be applied onto the proximal end 116b as the transition surface 117b of head portion 102b begins to interact with the engaging surface 212b of the aperture 210b. The interaction between the aperture 210b and the transition surface 117b of the head portion 102b forces the head to move in a direction that is generally transverse to the center axis 106 of the anchor 100a (see
Simultaneously, a second non-torsional force continues to be applied onto the proximal end 116b of the head portion 102b as the head portion is pushed farther into the first aperture 210a. The interaction between the inwardly sloped surface 212b of the aperture 210b and the offset portion 114b of the head portion 102b forces the head portion to keep moving in the transverse direction as indicated by arrow 218b. As discussed above, the transverse movement of the head portion 102b also causes additional transverse movement of the elongated body portion 104a, which causes the boney structure 250b to also move in the direction of arrow 218a and towards the boney structure 250a. The relative movement between the boney structure 250a and the boney structure 250b causes the gap 224 to significantly narrow.
Similarly, the head portion 102b has been pushed completely into the aperture 210b. As explained above, the interaction between the inwardly sloped surface 212b of the aperture 210b and the offset portion 114b of the head portion 102b has forced the head portion to move transversely in the direction of the arrow 218b. The transverse movement of the head portion 102b also caused the transverse movement of the elongated body portion 104b, which caused the boney structure 250b to compress against the boney structure 250a. The gap 224 is now closed as the boney structure 250a is pressed against the boney structure 250b. The magnitude or height of the offset of the anchor head portions 102a-102b and the angle of slope of the engagement surfaces 212a and 212b determine the amount of compression achieved.
In certain embodiments, the oversized geometry of the offset portion 114 causes a light press fit between the anchor head portion 114 and an aperture of an implant. Thus, in some embodiments, the offset portion 114 may be an oversized geometric volume which contacts a surface of the aperture of an implant. These are cylindrical surfaces which will largely be concentric in the final position, and in the offset portion 114 they may have an incrementally larger radius than the underside of the surface in the aperture resulting in being wedged together in the final position—which assists in preventing the anchor from “backing out” of the respective aperture. In yet other embodiments, other anti-back methods and techniques may also be employed, such as blocker plates, retaining rings, and locking screws.
For purposes of simplification, the implant embodiments discussed above have illustrated and described with an implant and two anchors. However, the present invention contemplates the use of implant embodiment systems using more than two anchors.
In alternative embodiments, one or more anchors may be a traditional anchor without an offset head portion. For instance in
Although the above discussion focuses on compressing boney structures together or compressing a boney structure against an implant, the above anchors and methods could also be used to cause distraction between a first boney structure and a second boney structure via a modification of the anchors and implants. By reversing or flipping the head geometry (i.e. offset portions 114) of the anchors 100a-100b and reversing or flipping the engagement surfaces and geometries of the respective apertures 210a-210b of the implants 200, distraction of boney structures can be achieved by using the methods described above.
While the above example uses anchors 100 with the two aperture implants 200, implants may have two, four, six or more apertures and the corresponding number of anchors and still be within the scope of this invention.
For instance,
In yet other embodiments, various components, for example the anchors 100 may be made from nickel titanium (also known as Nitinol®) or another shape memory alloy. The anchor would have a very specific shape at a cooler temperature, such as room temperature. Once inserted into a human body, the metal would rise to a body temperature which will cause the anchor to change shape to enhance compression.
For instance, at or below room temperature a straight anchor might be inserted. At body temperature, the straight anchor turns into a curved anchor and applies additional compression or distraction. Similarly, a curved anchor could turn into a straight anchor at body temperature to enhance either compression or distraction.
In yet other embodiments, the implant or parts of the implant may be formed of a shape memory alloy. For example in
The abstract of the disclosure is provided for the sole reason of complying with the rules requiring an abstract, which will allow a searcher to quickly ascertain the subject matter of the technical disclosure of any patent issued from this disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.
Any advantages and benefits described may not apply to all embodiments of the invention. When the word “means” is recited in a claim element, Applicant intends for the claim element to fall under 35 USC 112(f). Often a label of one or more words precedes the word “means”. The word or words preceding the word “means” is a label intended to ease referencing of claims elements and is not intended to convey a structural limitation. Such means-plus-function claims are intended to cover not only the structures described herein for performing the function and their structural equivalents, but also equivalent structures. For example, although a nail and a screw have different structures, they are equivalent structures since they both perform the function of fastening. Claims that do not use the word “means” are not intended to fall under 35 USC 112(f).
The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many combinations, modifications and variations are possible in light of the above teaching. For instance, in certain embodiments, each of the above described components and features may be individually or sequentially combined with other components or features and still be within the scope of the present invention. Undescribed embodiments which have interchanged components are still within the scope of the present invention. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims.
Some embodiments include: a method for joining a first boney structure to a second boney structure, the method comprising: positioning a supra implant adjacent to the first boney structure and to the second boney structure; introducing a first distal end of a first non-threaded anchor into a first non-threaded aperture defined within the supra implant, introducing a second distal end of a second non-threaded anchor into a second non-threaded aperture defined within the supra implant, applying a first non-torsional force onto a first proximal end of a first offset head of the first non-threaded anchor to drive the first distal end through the first aperture, and into the first boney structure along a first trajectory; applying a second non-torsional force onto a second proximal end of a second offset head of the second non-threaded anchor to drive the second distal end through the second aperture, and into the second boney structure along a second trajectory; continuing to apply the first non-torsional force onto the first proximal end of the first offset head as the first offset head reaches a first sloped engagement surface of the first aperture; continuing to apply the second non-torsional force onto the second proximal end of the second offset head as the second offset head reaches a second sloped engagement surface of the second aperture; causing the first offset head to interact with the first engagement surface of first aperture to move the first offset head transversely with respect to the first trajectory to cause the first boney structure to also move transversely with respect to the first trajectory; and causing the second offset head to interact with the second engagement surface of second aperture to move the second offset head transversely with respect to the second trajectory to cause the second boney structure to also move transversely with respect to the first trajectory.
The method above wherein the transverse movement of the first boney structure and a transverse movement of the second boney structure causes compression between the first boney structure and the second boney structure.
The method above wherein a transverse movement of the first boney structure and the transverse movement of the second boney structure causes distraction between the first boney structure and the second boney structure.
The method above and further comprising: introducing a third distal end of a third non-threaded anchor into a third non-threaded aperture defined within the supra implant, applying a third non-torsional force onto a third proximal end of a third offset head of the third non-threaded anchor to drive the third distal end through the third aperture, and into the first boney structure along a third trajectory; continuing to apply the third non-torsional force onto the third proximal end of the third offset head as the third offset head reaches a third sloped engagement surface of the third aperture; and causing the third offset head to interact with the third engagement surface of third aperture to move the third offset head transversely with respect to the third trajectory to cause the first boney structure to also move transversely with respect to the third trajectory.
The method above and further comprising: introducing a fourth distal end of a fourth non-threaded anchor into a fourth non-threaded aperture defined within the supra implant, applying a fourth non-torsional force onto a fourth proximal end of a fourth offset head of the fourth non-threaded anchor to drive the fourth distal end through the fourth aperture, and into the second boney structure along a fourth trajectory; continuing to apply the fourth non-torsional force onto the fourth proximal end of the fourth offset head as the fourth offset head reaches a fourth sloped engagement surface of the fourth aperture; and causing the fourth offset head to interact with the fourth engagement surface of fourth aperture to move the fourth offset head transversely with respect to the fourth trajectory to cause the second boney structure to also move transversely with respect to the fourth trajectory.
The method above wherein the causing the first offset head to interact with the first engagement surface of first aperture to move the first offset head transversely comprises applying a first force from the first engagement surface onto a first offset portion of the first offset head.
The method above wherein the causing the second offset head to interact with the second engagement surface of second aperture to move the second offset head transversely comprises applying a second force from the second engagement surface onto a second offset portion of the second offset head.
The method above wherein a direction of movement of the first offset head is opposite to a direction of the movement of the second offset head.
The method above wherein a direction of movement of the first offset head is linearly aligned with the direction of the movement of the second offset head.
Additionally, there also may be a supra implant system for joining boney structures comprising: a first non-threaded anchor having a first center axis including a first non-threaded elongated body; a first non-threaded head coupled to a proximal end of the elongated body, the first head including, a concentric portion of the first head that is substantially concentric to the center axis, and an offset portion of the first head that is offset from the center axis; a second non-threaded anchor having a second center axis including, a second non-threaded elongated body; a second non-threaded head coupled to a proximal end of the elongated body, the second head including, a concentric portion of the second head that is substantially concentric to the center axis, and an offset portion of the second head that is offset from the center axis; a supra implant including, a first end portion including a first aperture defined therein, the first aperture having a first sloped engagement surface, the first aperture sized and shaped to fully accept the first head only when the first sloped engagement surface engages the offset portion of the first head to force a first transverse movement of the first head; a second end portion including a second aperture defined therein, the second aperture having a second sloped engagement surface, the second aperture sized and shaped to fully accept the second head only when the second sloped engagement surface engages the offset portion of the second head to force a second transverse movement of the second; and a main body portion joining the first end portion to the second end portion.
The above system wherein the first sloped engagement surface is a first force applying surface sized and shaped to assert a first transverse force on the offset portion of the first head as the offset portion of the first head slidingly engages the first force applying surface.
The above system wherein the first aperture incudes a first opposing sloped surface opposing the first sloped engagement surface and the second aperture includes a second opposing sloped surface opposing the second sloped engagement surface.
The above system wherein the first aperture is longitudinally aligned with the second aperture.
The above system, further comprising: a third non-threaded anchor having a third center axis including, a third non-threaded elongated body; a third non-threaded head coupled to a proximal end of the elongated body, the third head including, a concentric portion of the third head that is substantially concentric to the center axis, an offset portion of the third head that is offset from the center axis; and a third aperture defined therein, the third aperture having a third sloped engagement surface, the third aperture shaped to fully accept the third head only when the third sloped engagement surface engages the offset portion of the third head to force a third transverse movement of the third head.
The above system, further comprising: a fourth non-threaded anchor having a fourth center axis including, a fourth non-threaded elongated body; a fourth non-threaded head coupled to a proximal end of the elongated body, the fourth head including, a concentric portion of the fourth head that is substantially concentric to the center axis, an offset portion of the fourth head that is offset from the center axis; and a fourth aperture defined therein, the fourth aperture having a fourth sloped engagement surface, the fourth aperture shaped to fully accept the fourth head only when the fourth sloped engagement surface engages the offset portion of the fourth head to force a fourth transverse movement of the fourth head.
This application claims the benefit of the filing dates of the following U.S. provisional patent applications: U.S. Patent Application Ser. No. 63/081,187, filed on Sep. 21, 2020, entitled SYSTEM AND METHOD FOR JOINING BONEY STRUCTURES; U.S. Patent Application Ser. No. 63/113,886, filed on Nov. 15, 2020, entitled SYSTEM AND METHOD FOR JOINING BONEY STRUCTURES; U.S. Patent Application Ser. No. 63/130,323, filed on Dec. 23, 2020, entitled SYSTEM AND METHOD FOR JOINING BONEY STRUCTURES; the disclosures of all of the above patent applications are hereby incorporated by reference for all purposes. This application also incorporates by reference for all purposes a commonly owned patent application entitled SYSTEM AND METHOD FOR JOINING BONEY STRUCTURES, U.S. patent application Ser. No. 17/248,943, filed on the same date as the present filing.
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