Patent Application
20240366401
This invention relates to orthopedic surgery and, more particularly, to novel systems and methods for anchoring to and between bone structures.
Orthopedic surgery has long depended on unique instruments and unique securement arrangements in order to encourage healing of fractures, regrowth of bone structures, and the like. Various securement mechanisms involve combinations of plates and screws, sometimes rods, and various other hardware.
Bones have a structure that is harder around the outside envelope (boundary) thereof, called cortical bone. Meanwhile, enclosed therewithin is medullar bone, sometimes called cancellous bone. Cancellous bone hosts the marrow and vasculature associated therewith. Consequently, the bone itself is quite porous and sparse, sometimes referred to as “spongey.” Cancellous or medullar bone material has less actual structural material forming around vacuoles containing soft tissues (marrow, vasculature, etc.). It has a lower value of maximum allowable shear stress, a reduced ability to maintain embedded rigidly therein a conventional thread of a screw.
Meanwhile, thread pitch is of the same order of magnitude as the height of the threads from the shank (solid shaft) of a screw. Thus, the actual “purchase” (physical engagement or contact between the screw and the structural material of the bone) is much less in the cancellous bone than in the cortical bone. However, the cortical bone is comparatively thin, typically, or a comparatively small fraction of many bones or bone structures and length of screws anchored therein.
That is, just as in wood, threads on a screw or similar hardware may simply shear (core out) the corresponding threads they cut into the receiving bone. Thus, pull-out strength may be severely compromised by the spiraling threads with their intermediate bone material therebetween. It would be an advance in the art to provide a more secure form of anchoring. It would be an advance in the art to provide anchors capable of securing into cortical bone and cancellous bone with reduced risk of simply “coring” out.
Meanwhile, bone regrowth or “through growth” around and through foreign objects such as screws, plates, spacers, or the like is to be promoted. It would be an advance in the art to improve spaces for “through growth” through spacers or frames used with anchors in various types of surgery.
It would be an advance in the art to provide anchors capable of securing one bone structure to another in order to promote joinder therebetween. It would be an advance in the art likewise to provide both spacers and anchors having apertures, porosity, highly textured surfaces, and the like in order to provide more shear strength, as opposed to mere friction securing new bone growth to spacers, anchors, and so forth.
In view of the foregoing, in accordance with the invention as embodied and broadly described herein, a method and apparatus are disclosed in one embodiment of the present invention as including an anchor selected from several types that may be directly driven (malleted) rather than screwed with a driver. Anchors may include a central aperture or channel along a center line, where the center line is itself curved, such as on a radius or arc. The anchors include splines. The splines may parallel the center line (which becomes a center curve in helical axis embodiments) as they extend radially away from a wall (also called a core) surrounding a central channel used to follow down a K-wire guide. Splines progress along the length of the core. Splines may be straight and along a linear central axis, helical with respect to a linear axis, or helical along a helical central axis. Helical splines have extremely long pitch compared to virtually any and all screws. By “long pitch” is meant that the pitch is typically multiple diameters, and most effectively multiple “lengths” long. Pitch represents a distance traversed by a flute (where a flute may be a thread or a spline) per revolution of rotational progress. The twist (angular distance in degrees, radians, or length per revolution) in a conventional screw is typically sufficiently small that a full 360 degree rotation (two pi radians, or 2×π radians) occurs at a fraction of the diameter distance.
For example, a one quarter by 20 (¼×20) bolt or screw has a one quarter inch diameter in which 20 threads or 20 revolutions of the threads occur in every inch of length. This means an inch of axial progress occurs in 20 complete circles or complete spirals of the threads. In contrast, an anchor in accordance with the invention has a pitch that is typically several lengths (even up to dozens of diameters) of the fastener or anchor.
Splines are angled primarily to travel along their length, while progressing along a helical path that will typically not make a full revolution within the entire length, or even a few lengths, but many (e.g., four, six, eight, or more).
Thus, such splines will typically make less than one quarter (usually from one sixth to one tenth) of a revolution or progress about the circumference within the entire length. Meanwhile the aspect ratio of diameter to length is itself less than a fifth to a tenth (1:5 to 1:10). In fact, the progression or the amount of angle traversed circumferentially is typically on the order of only one eighth (⅛) of the circumference or less.
Thus, anchors in accordance with the invention may be malleted (driven axially by impact loading) into place. Spiraling and twisting by the splines moves the anchor through the cortical bone and along both an arcuate centerline and a helical path through the cancellous bone therewithin. The result is that only a small fraction of the spline surface area aligns parallel to the pull-out direction (back toward the head. Thus, the splines resist any force tending to pull out, while they themselves present a significantly greater surface area and less load (pressure, force per unit area) against the cancellous bone than does a conventional screw.
The foregoing features of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding 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 with additional specificity and detail through use of the accompanying drawings in which:
It will be readily understood that the components of the present invention, as generally described and illustrated in the drawings herein, may be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the system and method of the present invention, as represented in the drawings, is not intended to limit the scope of the invention, as claimed, but is merely representative of various embodiments of the invention. The illustrated embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout.
Herein, a number of unique terms are used, and others have unique definitions. Definitions of conventional structures are inadequate to describe certain features of embodiments of certain features in accordance with the invention. Moreover, certain terms will be necessarily terms of art specifically defined herein due to the lack of any suitable definition in prior art or in the art to which this invention pertains. Likewise, sometimes a definition or group of definitions may need to be narrowed down to the specific intent desired in order to adequately describe and claim the invention described herein.
An aperture is basically a hole. An aperture through a thin material may be defined by a virtually two-dimensional plane. An orifice or an exit opening may be thought of as a plane past which a fluid flows. Other apertures may have to pass through a wall, or conduit, and therefore will not only have an area through which to pass, but also a distance through which to passes. However, the point of the use of the word aperture is simply to show that a hole has been created for some purpose. The length of an aperture is insignificant. That is, if a significant distance is involved, then a channel or a path is spoken of. That is not typically defined as an aperture, but a line, path, channel, conduit, or the like, and may even have an entrance, exit (both of which are planes), or both identified.
Orthogonal means two items are oriented at right angles to each other. However, orthogonality applies in all kinds of reference systems. In polar coordinates a radius from an axis is based on circular, planar geometry, while the azimuth or the distance along that axis may be defined either by an angle from an axis or a distance from a reference plane. Similarly, spherical coordinates have a frame of reference in which an angle must be defined from three different axes or with respect at three different axes, and a radius to a location must be defined. Herein, orthogonal means that two items, axes, directions, forces, or anything else capable of being characterized by a directionality are oriented at right angles to one another.
However, effectively orthogonal is used to mean that the two items need not be at the exactly orthogonal angles but they are at an angular orientation that if they were connected rigidly, relative motion would be precluded outside the plan of their intersecting axes. In general, three dimensions can be defined in a set of any three coordinates using radii, axial distances, translating distances along Cartesian coordinate axes (rectangular three axis geometry), and so forth. Therefore, it may be necessary sometimes to refer to items that are effectively orthogonal, effectively parallel, or the like.
One reason for this “effective” adjective is the fact that bones are round not square. They tend to have rounded surfaces, edges, and ends, not sharp points. Thus, in running an anchor into a joint “effectively parallel” to the joint or to the two cortical surfaces that are to be fixed “rigidized” to one another will not necessarily be parallel. A straight object may be parallel to a tangent surface (plane instantaneously parallel at a point of contact) or pass along an undulating surface, and thus be called “effectively parallel.
Similarly, an anchor may pass primarily through a cortical surface of a bone, being “effectively” or “primarily” orthogonal thereto. Likewise, two bones may be spaced apart and extend so for some distance, even though they may be rounded conformally with one another or congruent with one another. Thus, the parallelism or the orthogonality may not be absolute. For that purpose, the term “effectively” may be used with the principal term parallel or orthogonal.
Likewise, principally parallel or principally orthogonal are used herein to mean that a device or a force or the like has an effect (typically its greatest effect) in a parallel direction or an orthogonal direction, even though the exact angle may not be precisely parallel or orthogonal. In general, one may rely on the fact that effectively parallel means that a tangent surface or tangent line may be approximately parallel to another even though both are curving.
Likewise, principally orthogonal means that most of the orientation is in the orthogonal direction, notwithstanding it may also involve angular variation in other dimensions as well or even in the direction that was intended to be orthogonal but cannot be due to curvatures and so forth. One may typically regard principally parallel to mean less than forty five degrees off of parallel. One may consider principally orthogonal to mean less than forty five degrees off of orthogonal. Most typically, the angular discrepancy will be much less than forty five, much less than thirty.
An implant herein is anything that is embedded in the body of a subject by surgery, minor or major. The anchors used are considered to be implants, because they are intended to take a permanent place in the body, in this case between bones. An anchor as used herein may be relied upon to hold a bone in at least one degree, and typically at least two degrees, of freedom with respect to the anchor. It may anchor to another bone in more degrees of freedom.
Typically, an anchor will hold two bones with respect to one another in at least two degrees of freedom. For example, if an anchor has an axis, and that axis passes through two bones effectively orthogonally with respect to their cortical surfaces, then any plane perpendicular or orthogonal to that axis has two dimensions, and the axial orientation of the anchor fixes those two bones with respect to one another in those two degrees of freedom, the two degrees of freedom that can be used to define the plane perpendicular to the axis of the anchor.
However, in some embodiments, an additional degree of freedom or more may be fixed by virtue of the angles, or by virtue of additional anchors. Meanwhile, those anchors, in the case of multiples, may each fix two bones in two degrees of freedom, and yet duplicate restriction in certain of those degrees of freedom. The action of splines tends to fix anchors in a third degree of freedom.
By degrees of freedom is meant one of the six possible degrees of freedom in a three-dimensional, Cartesian space. In a Cartesian space, three axes, orthogonal to one another, and typically called an x, y, and z axis, define the space. Translation (linear motion) in any direction may be defined in terms of motion or displacement along each of those axes. However, in addition to translation, rotation may also occur. Rotation may similarly be defined according to degrees of rotation of any object or thing about any of those three axes.
The vector algebra may be somewhat complicated. Therefore, it is possible and often relied upon, to use a coordinate system centered, that is it has its origin in or on an object itself. This often simplifies the mathematics by fixing the axis system for translation and rotation to the object, rather than some arbitrary location in space, which might otherwise complicate the mathematics.
By fixing two objects or any object in a degree of freedom means that the freedom to move in that particular direction or degree of freedom has been restricted. Thus to restrict in degrees of freedom is to fix against movement in those particular degrees of freedom, where the degrees of freedom involve three axes of translation (linear movement in the directions of the axes) and any rotation about each of those three axes.
Various definitions used herein or terms needing definitions may include medical terms. For example, distract, means to move apart in tension, such as distracting two bones or distracting ligaments. Typically, in the SI joint (sacroiliac joint) the bones may need to be distracted or moved apart from one another resulting in tensioning or stretching ligaments. Both of these are considered distracting. Stretching or stressing a tissue is to distract it. Likewise, to move two items apart is to distract them.
The medical terms for direction may be used, as well as directional terms. Thus, posterior means rear, anterior means front, superior means above, inferior means below, lateral means a side, and typically means laterally from a center plane of the human body. Likewise, medial typically means at or near or toward a center plane of symmetry through the body, so one may speak of laterally or medially as far as positioning or motion. Pronation is rolling or rocking forward. This would be considered pitching in in aeronautic parlance. Pitching forward, that is nosing down is pronation. Pitching upward, nose up or pitching backward nose up is considered to be supination.
By access herein, is typically meant posterior access or a lateral-posterior access. Posterior access means access through tissues behind the sacroiliac joint whereas lateral-posterior means accessing at an angle that will give access from a side of the ilium but toward the rear, as opposed to from a frontal or anterior access.
Herein, anchoring means that the anchors or an anchor crosses both of the cortical surfaces that it is intended to fix with respect to one another. Parallel engagement or within-the-joint engagement means that an anchor is being installed along the two cortical surfaces sharing a joint, thus distracting the ligaments that hold those bones together. An anchor engages both the bones with at least splines on the anchor, thereby forming a stable fixation. The ligaments drawing the bones together and the anchor cutting into the bones with the splines and distracting the ligaments provide a stabilization.
Materials of the anchors may be inert metals, meaning that they will not react nor degenerate in the presence of materials naturally occurring in the body. However, polymers (plastics) and filled (reinforced) polymers, are improving all the time. Certain ones of these materials may be suitable for certain anchors in certain positions. Likewise, bone itself may be machined to form an anchor, and may thus eventually be subsumed within the bone growth fixing permanently a joint.
Typically, these types of grafts are called allografts, or homografts where the bone is from a same species, but not necessarily of a same blood type, and so forth, with autografts being from the subject itself. Meanwhile, it is conceivable that an autograft (from the subject) may be used, but this is less likely. An autograft involves using bone from the very subject of a surgery. Sacroiliac joint fusions or fixations are typically undertaken due to degeneration of the joint. This is typically a function of health and age. Accordingly, limitations on obtaining an autograft and using it, make it a less reliable option.
Force means force, a fundamental parameter of physics. It may be measured in any units of force. Stress means a force applied per unit area. Stress may occur in tension (drawing apart), compression (forcing together) or shear (force tending to slide one portion in an opposite direction from an adjacent portion). The units of stress are force per unit of area. Any units of force and any units of area may be used to define a stress. Strain is a fraction having no dimensions (units) in that it is a measure of stretch (change in length) in compression or tension of any material per (as divided by) the unit length. Thus, strain is inches per inch, microns per micron, meters per meter, or any length over (divided by) length, meaning it is a dimensionless (no units of measurement) value.
“Grow-through” means that a region has a porosity, an aperture, a window, a lattice, or some other vacancy through which bone may grow in order to strengthen the region and the attachment where an anchor or implant has been implanted (installed).
“Grow-on” identifies a characteristic of a material in which a texture includes shapes, convex, concave, some combination, or the like that do not pass through the wall onto which these textures are formed, and thus cannot allow bone to grow-through them, but bone may grow around them, and have strength due to the shear strength (shear being a technical engineering term meaning stress in a material orthogonal to the applied force). A coefficient of friction exists between any two materials.
The coefficient of friction is defined as the amount of force required to slide one material along another in a plane per unit of normal force forcing the two materials together at the plane. This is often defined as a Force equals Mu times N, where N is the normal force pushing the two materials together at their surfaces, Mu is the coefficient of friction (a property of those two materials in contact), and the force is the amount of force required to cause them to slip at that interface surface. Again, the coefficient of friction is dimensionless (unitless) because it is the ratio of two forces acting. One benefit of surface texturing is that it does not permanently rely on a coefficient of friction between surfaces, but rather provides small pillars extending up into the bone as it grows and to which the bone may attach itself.
“Pull-out” resistance or force represents a force required to withdraw a fastener once it has been inserted by pulling on that fastener from the direction in which it was forced into place. Screws are typically problematic in this type of testing. Because screws advance only a small fraction of their diameter with each rotation of the head, the threads act like blades or scrapers. Thus, as those threads thread into a material like bone, they are so close together (axially), and have so compromised the material penetrated, that drawing a screw out of the place where it has been threaded in will often “core out” the bone (literally shear out all the material engaged by the threads) where it had been originally threaded. This may happen intentionally or accidentally.
In an apparatus and method in accordance with the invention, threads are not used. Rather splines that extend helically at a very long pitch, where pitch is the distance between one revolution of a helix about a central axis, and the next revolution to the same circumferential point advanced along the helix. Thus with screws the pitch length is often a small fraction of a diameter of the screw. Certain types of screws in woodwork such as bugle-head screws or sheetrock screws, or the like have a larger pitch compared to machine screws, conventional threads, bolts, and the like with lesser pitch. Both are effectively wedges of a few degrees, about 3 degrees off a plane normal (perpendicular, at a right angle) to the longitudinal axis for a machine screw and about 10 degrees for a bugle head screw.
In contrast, a helical spline in accordance with the invention typically has a wedge angle of about 2 to 15, usually about 3-5 degrees back from an axial direction (75 to 88, usually 85 to 87. This compares to conventional screws having an angle of from about 2 to 15 degrees from a plane normal to an axial direction, almost perpendicular to the advancing angle or wedge angle relied upon in a system according to the invention.
One may think of any helical screw as a wedge that is simply coiled around itself so that the wedge may continue advancing longitudinally throughout multiple revolutions. Each revolution is a wedge having a length of Pi times the outer diameter of the screw. Each rotation of a screw advances axially by the distance of the pitch (crest to crest of each adjacent pair of threads). Even a very short, sheet metal screw must have one full turn of threads on a length of about one diameter.
In systems and methods in accordance with the invention, threads are not used. Instead, helical splines are used. Splines as used herein are helical walls that extend out from a central core or even a central axis. These splines extend radially outward but also extend longitudinally in a helical pattern that rotates around the core as they advance longitudinally along the length of the anchor. In accordance with the invention, the helices are not screw threads because their pitch is multiple lengths of the anchor. This means that a spline never completes a single rotation or a single 360 degree helical path around the core.
Typically, an odd number of splines is preferred, and that odd number of splines may be three, but is typically five, and may be more. Pitch does not depend on the number of splines. Three to seven splines may serve, but five splines have been found suitable in practice for both manufacturing and use. A typical pitch in accordance with the invention is greater than five lengths of the anchor, and may be more.
In general, herein, a long pitch means a pitch greater than the total length of the splined portion of an anchor, wherein the length of the anchor is greater than two of its greatest diameter around the splines, and typically about five diameters or more. Nothing sold as a “screw,” “bolt,” or other “threaded fastener” can qualify as having a “long pitch.” A very long pitch is at least two, and typically three to more than five times the splined length of an anchor of length greater than two diameters. Typical anchors are two to ten, typically about 5 diameters long, and have a pitch of more than five lengths of the anchor. This translates to about three and a half degrees of angle from a longitudinal, axial line drawn at the outer surface of the core from which the splines extend. The rotational (helical) advance along the longitudinal axis of an anchor is an order of magnitude less than that of a screw. When comparing anchors of the invention to advance angle or wedge angle of screws, the screws typically measure less than eight degrees for that angle, and typically closer to three degrees for that “wedge angle”.
Meanwhile, the term spline herein is used to mean a specific structure. Conventional splines typically involve connectors in which lands, extending radially outward as part of a shaft, alternate with grooves machined radially down into the shaft, alternating circumferentially between the lands. Typically, the circumferential distance across a land and an adjacent groove are essentially the same. Even when a spline has a triangular shape that comes to a single ridge, or if it is a “buttressed” trapezoidal shape adjacent a machined groove, the circumferential distance across the middle or the median radius of a land is the same as that of a groove.
Herein, the relative dimensions circumferentially are much more disproportionate. A spline is more like a thin blade compared to other splines and the grooves here. The groove occupies the great majority of the circumferential distance, and the spline occupies a relatively small fraction, typically about a fifth or less. This may be as little as one tenth of the circumference covered by splines, and ninety percent covered by grooves. However, this will depend on whether the spline and anchor are formed of a metal, a polymer, or bone.
Barbs, texturing, and grow-through regions may be used for resistance to sliding of bone with respect to an anchor along the longitudinal and axial direction of an anchor. Barbs and texturing may have an immediate effect against sliding, which is improved as bone growth continues. Grow-through areas initially provide insignificant resistance to axial displacement of bone along an anchor.
St. Venant's principle applies to most solid materials. Especially isotropic materials. Isotropic materials are materials in which the mechanical properties are the same in every direction. Cortical bone is typically isotropic. Cancellous bone, the central or marrow portion of bone is also typically isotropic. However, cancellous bone is much weaker and includes an almost sponge like hard structure filled in a mushy marrow, including vascular material. Thus, cancellous bone does not support force in any direction well. Cortical bone does support forces much better. Nevertheless, cortical bone, being essentially isotropic obeys the conventions of solid materials.
St. Venant's principle observes that stress or load (load being a force or a stress) begins distributing itself immediately from the point of application of the load out at a forty five degree angle. That forty five degree angle is a line, plane, or surface of principal shear stress. Maximum shear stress supportable is typically half the value of maximum compressive stress and maximum tensile stress supportable. Accordingly, driving screws into bone often has the effect of damaging the bone by forcing a shearing failure, flaking off chips of bone along the planes of principal shear. Accordingly, in accordance with the invention, drills, broaches, and the like are used to pilot and thereby reduce the stresses placed by anchors on cortical bone material.
Mohr's circle of stress defines maximum shear with respect to maximum compressive stress and maximum tensile stress. Mohr's circle of stress actually defines the principal stress line (in two dimensions), which moves away from the forty five degree plane depending on whether a second force other than a single direct compression or direction is being applied orthogonally to a first force.
Asymmetric splining herein is used to define and indicate the fact that the grooves are a much different (typically larger, but possibly smaller) portion of the circumference of an anchor than is a spline. Lands and grooves are not of similar dimensions.
Some terms used herein are not necessarily common. The term “pitch advance ratio” is a term coined herein to mean the circumferential distance (at maximum spline diameter) advanced by a single spline of an anchor divided by the overall length of an anchor. Thus, over the length of an anchor, a pitch advance will occur that is much less than the length, because the pitch is itself many times the length. It is typically less than Pi times the maximum diameter divided by five times the length. With fewer splines, it is not necessarily proper to use the number of splines to define pitch advance, because the issue is not dependent on number of splines, but the angle of progression of the spline circumferentially corresponding to advance axially along the length of the anchor, from which the spline radially extends.
The term “pitch length” means exactly the same as pitch length as pitch in screw threads. Pitch is the distance from one peak to the next peak along a threaded shaft, such as a screw or bolt. It is the distance that the screw or threaded rod travels for each rotation of 360 degrees by the head. Herein, the term “pitch advance angle” is a coined term meaning the angle that the helical spline makes with a plane that passes through the center line of an anchor.
In other words the angle made at any point along the length of a spline between two planes passing through that point, one plane through the centerline of the anchor and the other plane passing through that point and tangent to the middle of the spline, or central surface. It measures the angle that the ongoing helical path of that spline makes with the anchor's centerline plane makes at the outermost radius of the spline. Thus both planes extend radially, and pass through that point on the outermost radius. One plane passes through the centerline along the length of the anchor and one passes through the center “plane” tangent to the spline. Both planes may be tangent planes whenever the centerline of the anchor is curved rather than straight.
The term “pitch swept angle” is used to mean the total angular difference between a plane passing through the center line of the anchor and the center line of a spline closest to the head end or base of an anchor, and a plane through that center line of the anchor and the center line of the spline closest to the point end or leading end of the anchor. Thus, on a clock face, the pitch swept angle measures how much circumferential progress the spline makes over the length of that spline in an anchor.
Herein, the term plane will seldom apply to any physical part or location in a bone, other than an imaginary plane through certain points or lines. This is because bones are fundamentally rounded everywhere. They are not sharp and they are not angular. Accordingly, when two bones have curvature, one may pick a location on one bone and a corresponding location on another bone and one may draw a tangent plane to any surface. Any time the “plane” of a bone surface is spoken of, and it is not a plane, one may understand the plane to mean a tangent plane. Any plane through an actual line is exactly the same as in mathematics
Referring to
Typically, the bones 14 may be defined by the body part to which they pertain. The body may be used to define directions 11 with respect thereto (e.g., a human or an animal, but typically a human). In the illustrated embodiment, the direction 11a is a vertical direction 11a, while a lateral direction 11b may be thought of as a left or right direction.
In medical parlance, lateral is an expression meaning toward the left or right side of a subject outward. Meanwhile, medial is used to mean toward a center plane or center of symmetry of a subject. Here, lateral and medial will be used as in medical technology. However, a lateral direction 11b will be either left or right without regard to whether it is traversing in a lateral direction, with respect to the subject, or a medial direction. Finally, a direction 11c covers any forward or backward (anterior or posterior) direction with respect to a subject. Thus, a direction 11c refers to that front and rear, forward and backward, direction. Nevertheless, without a reference number, anterior and posterior maintain their same medical meanings, as do lateral and medial, as well as superior (up) and inferior (down).
An anchor 12 may be used in multiples with or without a frame 30 (see, e.g.,
For example, in certain illustrated embodiment, bones 14 are exemplified by a sacrum 14a and an ilium 14b. The ilium 14b presents several surfaces, edges, and processes (projections). Of particular interest in navigating before and during surgery are the iliac crest 14c and the posterior superior iliac spine 14d (PSIS 14d), typically abbreviated to PSIS 14d. These bones 14 may be referred to generally as bones 14 or by the trailing letters as 14a, 14b, 14c, 14d designating specific instances 14a, 14b and portions 14c, 14d (regions 14c, 14d) of particular items within the classification or type, here identified by the number 14 for bones 14. Herein, a reference numeral will refer to a type or class of items, while that same reference numeral with a trailing letter refers to a particular instance, example, or configuration thereof.
The bones 14a, 14b may meet at a joint 15 or bone interface 15. In certain illustrated embodiments, that joint 15 is known as the sacroiliac joint 15. The joint 15 itself is actually formed of flexible, cartilaginous material between the bones 14a, 14b, while the bones 14a, 14b themselves are drawn into close proximity by ligaments tensioned to put the bones 14a, 14b and intervening cartilage in compression. With age, deterioration, disease, inflammation, or the like, a particular joint 15 may become damaged, partially destroyed, and otherwise subject to excessive motion between the two individual bones 14a, 14b interfacing at the joint 15. Accordingly, a “fixation” (secured in fixed relation in order to grow rigidly together) as that term is understood in orthopedic surgery, may be required. When the flexible joint 15 becomes too flexible due to damage or degradation, movement may cause abrasion and other damage between the bones 14a, 14b resulting in inflammation, pain, and further damage. Bones 14 may fuse or be fused to rigidize and literally grow together across the joint 15. The joint 15 may be scraped to promote active bone healing and growth, and to remove ineffective cartilage and its debris remaining in the joint 15.
In a sacroiliac joint 15 as illustrated, anchors 12 may be inserted in a medial direction 11b through the ilium 14b into the sacrum 14a stopped only by the head 16 of the anchor 12 at the cortical type bone 14 near the outer surface of the bones 14a, 14b. A center line 17 of each anchor 12 is arcuate in shape in certain embodiments, straight in others. It may be or lie within a single plane, or may itself be helical in shape having a curvature circumferentially as well as radial along its length. Such an embodiment would reflect an extremely long pitch (several lengths of the anchor 12 per 360 degrees of revolution or progression of a spline 20 proceeding therealong and therearound). A very long-pitch, centerless screw (or any thread external to a central portion) may be thought of as a coil or wedge in operation. It does not necessarily have to include any actual matter along its center line, yet spirals about a central axis whether that axis is straight, curved, or helical.
Each anchor 12 regardless of its particular type 12a, 12b will typically have a point 18 or a leading edge 18 as its point, respectively. A pointed anchor 12a may have all splines coming together to form a specific point 18. Meanwhile, a hollow (cored) anchor 12b, having a tubular shape inside the splines 20, thereby leaves either a sharpened cutting edge 18 as a leading edge 18 to promote its progress through bone, or a hollow core to follow a K-wire as explained below. A pilot hole may be drilled for starting an anchor 12 and typically need only extend a short distance (typically about three diameters). Inasmuch as the helical splines 20 extend away from the center line 17 (curve 17), each anchor 12 rotates into position following its point 18 or leading edge 18 and the path dictated by the splines 20.
The splines 20 extend radially, and progress axially as well as angling circumferentially about the center line 17 of an anchor 12. In the pointed embodiment 12a, virtually the entire anchor 12a is formed of splines 20 extending radially and axially from and along, respectively, the center line 17. In contrast, the hollow anchor 12b has splines extending away from a lumen 22 or channel 22 defined by a wall 23 spaced from and traversing along the arcuate center line 17. From that wall 23 around the lumen 22, the splines 20 extend radially. Splines 20 have at least one of three possible mechanisms (texture, porosity, apertures) for encouraging securement thereto by the surrounding bone material.
For example, the lumen 22 may actually be accessible by elongated, somewhat rounded, oblong apertures 60. For example, apertures 60a through the splines 20 may permit bone grow-through individual splines 20. Likewise, apertures 60b through the wall 23 may permit bone growth inside and through the lumen 22 and connecting through those apertures 60b to bone growth between adjacent splines 20.
In addition, the splines 20, the wall 23, or both may be formed of a porous material (e.g., sintered metal) provided with a rough texture. Sintering provides particles of a metal that are partially melted at their interfaces in order to provide an atomic bond between adjacent particles, while still leaving small, often microscopic interstices therebetween. Accordingly, fluids, gases, and cellular structures inherent in bone 14 may actually grow into, through, or both, with respect to such splines 60a or walls 60b. Bone will typically grow-through the porosity itself as well as through any larger apertures 60. Thus, one may think of a grow-through-aperture 60 (GTA 60) as a comparatively larger aperture 60, although a porosity of much smaller effective diameter (defined as 4×area÷perimeter) through the solid material itself may also exist.
The texturing on any given component such as a spline 20 or wall 23 may provide resistance against shear. That is, a texturing provides concavities and convexities at the surface itself of a solid, thereby resisting the physical shearing that might otherwise occur between a hard, slick, slippery, smooth, and non-bonded surface of a solid with respect to adjacent material of a bone 14.
Referring to
The individual anchors 12a, 12b, 12c, 12d are instantiations of anchors 12, generally. In the illustrated embodiment of an installation of a plurality of anchors, various options are illustrated. For example, the anchor 12a is positioned high (superior) and posterior from the main hip joint. It may be located by identifying the posterior superior iliac spine (PSIS) which provides not only a navigation aid, but a positive location for positioning an anchor 12a that crosses the SI joint 15.
In order to provide resistance to relative rotation in anything like a vertical plane defining a joint between the sacrum 14a and the ilium 14b, additional anchors 12b, 12c, meaning either one or both, may provide restrictions against rotation about the anchor 12a by either of the bones 14a, 14b being anchored together by the anchor 12a. In certain alternative embodiments, one or more anchors 12d may be placed actually within the joint 15, thereby distracting the ligaments holding the sacrum 14a and ilium 14b together, inducing tension in the connecting ligaments and providing compressive pressure against each of the bones 14a, 14b. These anchors may be discussed in further detail hereinbelow.
Referring to
A surgeon may use a mallet 42 to drive an anchor 12 into bone 14 with or without a frame 30. The mallet 42 provides an impact loading (momentum, impulse, time and force). Impact is a comparatively short event. The mallet 42 transfers momentum of its motion and mass into a handle 46, a cutting edge 18 or leading edge 18, such as a point 18. It will cut into both cortical bone and cancellous bone, subject to circumferential loading on the surfaces of the splines 20.
Momentum has “units” of mass times velocity. Impulse has units of force times time. Energy has units of mass times the square of velocity. The mallet 42 transfers energy and momentum into the handle 46 upon striking. The handle 43 is held by a surgeon to position and optionally to provide a certain rotational (circumferential) force urging the handle 46. The tool 44 will typically be rigidly secure between the handle 46 and shaft 48. The shaft 48 extends from inside the handle 46 to a point 50 that operates as an interface 50 with the head 16 of the anchor 12. The splines 20 are oriented to pass circumferentially 70c simultaneously. They present a much larger surface area (the sides or surfaces of the splines 20). That spline surface area will tend to urge the point 18 (regardless of whether actually pointed or hollow in the direction of the helical path of the splines 20.
The front or leading edge of each spline 20 must effectively cut through bone, but presents comparatively much less surface area. Accordingly, even cancellous bone will tend to rotate the anchor 12 by moving the splines 20 circumferentially as they move axially along their direction of travel.
A surgeon may apply a moderate force in a circumferential direction 70c around the handle 46, in the same direction that the splines 20 angle or drift as they progress from the head 16 toward the point 18. This will assist the slow rotation into local bone that may otherwise tend to absorb more momentum from the splines 20 in rotating the splines 20 moving along their trajectory.
Urging circumferential 70c rotation of the handle 46 is not required, but may result in less trauma to the bone 14 responsible to provide circumferential force rotating the anchor 12 along its path. Of course, the point 18, terminating at the end of the arc that represents the center line 17 (center curve 17) through the anchor 12, will tend to arc along that path. Whether circular or spiral in and of itself, the path is followed by the splines 20. Possible rotational 70c urging of the handle 46 by a surgeon may help.
Again, a frame 30, of any suitable shape for the space to be accommodated, may be used or not. In certain embodiments, the distractors 49a, 49b may be used to move tendon, muscles, or other tissue layers from an area into which a frame 30 is to be placed. Distractors are well known in the surgical art and need not be described in detail here. Suffice it to say that they operate in an opposite direction from forceps to spread tissues apart clearing space for a procedure to take place. Such a procedure inserting a frame 30 past tissues into a joint 15 between bones 14. Thus, the illustration of
The points 50 or interfaces 50 may be made in various configurations. For example, the point 50a has a slot 51a for receiving a crossbar 52 flanked on each side by a key 51b (slot 51a, key 51b, crossbar 52a, and the relief 52b in the illustrated embodiment of a head 16). For installation or insertion of an anchor 12, the point 50a may be suitable. In other embodiments, a square point 50b may be used to fit into the head 16. Alternatively, a hexagonal or other commercially available point 50c may be relied upon. The function of each of the heads 50 is to apply the impact load from the mallet 42 through the tool 44 and into anchor 12 along its axial direction 70a and, optionally apply a slight torque circumferentially 70c.
The engagement by a key 51b in a key way 52b or relief 52b may engage to provide a certain circumferential 70c torque. Torque is a force at a distance and therefore has units of force times distance. Axial force plus torque are suitable for progressing the anchor 12 both axially 70a along the arc of the center line 17 (center curve 17) and circumferentially 70c along the helical path described by the splines 20.
The points 50d, 50e may be used for insertion, but may provide additional features including a threaded stud 53a and a hook 53b. The threaded stud 53a may actually rotate with respect to the hexagonal point 50c in the device 50d, thereby permitting engagement of the female thread inside the head 16, for extraction. The hexagonal head 50c may penetrate into the head 16, after which turning a knurled handle, a T-handle, or another mechanism allows the threaded stud 53a to advance forward with respect thereto out of the hexagonal head 50c.
A polygonal (e.g., hexagonal) head 50c may provide secure engagement for rotation in a circumferential direction 70c. The threaded stud 53a provides secure axial 70a engagement with the head 16 in order to draw back along the center line 17 (center curve 17). The handle 46 may be rotated in an opposite circumferential direction 70c from that of insertion. Accordingly, the anchor 12 may be removed by pulling and rotating. This will be on the same trajectory on which it passes into bone 14 to which it anchors. The significance of the threaded stud 53a and the hooks 5d, 50e is that axial tension is not employed during the insertion process. Insertion needs only force or impact applied in an axial direction 70a, although some torque may assist.
Removal or loosening of the anchor 12 by the bone 14 does not occur readily because the axis 17 is curved not straight and the splines 20 are not aligned with it. That curve 17 has been modified in a helical path driven or guided by the splines 20. Accordingly, a force near the head 16 trying to force apart adjacent bones 14a, 14b is resisted by every spline 20 at its angle. That angle is not aligned with the axial direction 70a at the head 16 itself. Rather, along the entire length of the splines 20 the direction of force is continually changing.
The orientation of each spline 20 surface changes along its entire length to secure the splines 20 and thereby the entire anchor 12 in bone 14, even cancellous bone. Pitch is pitch. Long pitch is a pitch longer than a length, where length is more than twice maximum diameter. Very long pitch or extra-long pitch means pitch is several lengths, typically greater than two and more typically greater than five, with the same or lower ratio of diameter to length. One will note that due to the extra-long (multiple anchor 12 lengths) pitch, the mallet 42 and tool 44 may drive the anchor 12 into the bone 14. After that, the splines 20 provide a comparatively large surface area engaged at a comparatively modest force exactly the opposite effect as a conventional screw which tends to shear any cancellous bone into which it is anchored.
In fact, many conventional screws operate more like a sheet metal screw. A sheet metal screw passes through a single thin layer that is typically considerably less than one inch in thickness. One pitch is the difference in length between the crest of one thread and an adjacent thread. Not only do the splines 20 in accordance with the invention put less pressure on the cancellous bone, that pressure is distributed over a substantially larger area. There is not a location where the shear of a few threads can accumulate in close proximity to one another and at the exact same diameter as one another, in that nearly the same axially 70a location can be pulled through cancellous bones. Thus the coring out by simply stripping the threads cut into the cancellous bone is avoided.
Similarly, the hook type point 50e, similarly to the stud type point 50d, may engage the head 16, this time by a crossbar 52a. Meanwhile, the shaft 48 fits into the head 16 of the anchor 12. For example, the hook point 54b may pass into the head 16, past a crossbar (as in
Referring to
The tool 44 may have any of the engagement mechanisms 50a through 50e for driving, drawing, or both against the head 16. It may urge the point 18 or cutting edge 18 axially along the center curve 17 or center line 17. Progress along the center curve 17 necessarily drives the distal end of the anchor 12 at the leading edge 18 or cutting edge 18 (also called the point 18) along the axial direction 70a, where directions 70 are all with respect to the axis 17 or center line 17 through the anchor 12 along a curve 17.
Like the frames 30, the anchors 12 may be formed of a sintered material providing a porosity that can be penetrated in a straightforward manner by cellular material within a bone 14. Following insertion of the anchor 12, with the leading edge 18 or point 18 advancing first into the bone, and typically terminating when the head 16 abuts the cortical bone 14 or as shoulder countersunk therein. That is, the head 16 may be countersunk into cortical bone 14. There is substantial benefit to leaving the head 16 outside the cortical bone 14 material in order that the splines 20 may be stabilized by the cortical bone 14, and so that the head 16 may secure one portion of bone 14 to another.
To that end, a grow-through-aperture 60 or GTA 60 may be provided in any suitable portion of an anchor 12. For example, in the illustrated embodiments, a GTA 60a provides an opening 60a through a spline 20. It may be dressed or shaped to promote engagement with bone growth therethrough. Similarly, the wall 23 of the spline 20, surrounding the lumen 22 or channel 22, may likewise be perforated with GTA's 60b at some suitable length and width, spaced apart at an effective, intermediate spacing therebetween.
One will note that the helical trajectory of an anchor 12 upon entry into bone 14 is guided by the splines 20, which may in turn be guided or not by apertures 32 in the posterior wall 36a of a frame 30. Regardless, a suitable amount of urging in a circumferential direction 70c while driving or malleting an anchor 12 into place, the point 18 and splines 20 will move the distal end in accordance with the forces applied in a circumferential direction 70c by the splines 20 themselves. Thus, a combination of the splines 20 moving against already penetrated cancellous bone 14, as well as the outer cortical bone 14, will urge the rotation about the center curve 17, even as the arcuate shape of that center curve 17 within the anchor 12 imposes its own arcuate direction on those helical splines 20. That is, moving forward, the arcuate shape of the center curve 17 and consequently the anchor 12 will tend to move in an arc from a point of insertion. Meanwhile, the splines 20 and optional urging on the handle 46 in a circumferential direction 70c will also move that point 18 on a helical path combining the arcuate shape along the center curve 17, and helical shape (and resulting orientation) of the several splines 20.
To a certain extent, the angle 64 between adjacent splines 20 may be selected according to engineering principles. Likewise, the overall radial 70b dimension or height in a radial direction 70b of each spline 20 may be balanced against the diameter across the lumen 22. For example, the embodiments of
In practice, the curvature of the path of leading edge 18 or point 18 is a combination of the center line 17 or center curve 17 and the helical disposition of the splines 20. This results in the adjacent bones 14a, 14b across a joint 15 being held firmly. The force direction across the joint (perpendicular to) a plane of the joint 15 is almost never aligned with the majority of area of the splines 20, especially following installation.
Referring to
For example, a tool may fit between the splines 20 like pieces of a pie divided by the splines. Alternatively, a tool may simply engage a few splines with thin clips leaving the space largely open between splines. All the features and function of this description of
In other embodiments, a distal end of an insertion tool may fit inside the aperture 22, with small fingers or simple interfering stubs extending outside the wall 23 and aperture 22. Those may engage splines to support rotational forces without presenting substantial resistance against the insertion tool following the anchor 20 as the anchor moves a distance longer than its length into or across a joint. Even the insertion tool may be cored (hollow), having a mere rim fitting inside and outside the aperture 22, and having slots to receive splines 20. Such a tool presents little more resistance to movement forward, permitting insertion along a path much longer than the anchor 20 itself. Thus longitudinal positioning of an anchor 20 need not be limited by a head 16 at a proximal end of the anchor 20.
Thus, for example, certain SI joint fusions relying on an anchor 12 passing somewhat parallel to the adjacent faces of the sacrum and the ilium may rely on an insertion path longer than the anchor 12 itself. Neither the cortical bone nor the tool need stop the anchor, lacking a “bulkhead-like” face to stop forward progress of the distal (point 18) end.
In all of the foregoing discussion of surface roughness or “texturing,” one should remember that shear forces along a slick, smooth, hard surface of a spline are going to be comparatively weak (compared to a textured surface having mechanical engagement of interfering projections “sticking out” from the nominal surface). On the contrary, just as apertures 60 engage tissues for through growth, texture provides concavities and convexities for “on growth.”
However, the surface shear forces (slip of any bone tissue with respect to a hard, artificial surface of an anchor 12) are augmented by local compressive and tensile forces on the bone material, supported by mechanical tension, compression, and shear forces in the texturing features themselves. The presence of texturing provides immediate “purchase” or grip. Nevertheless, the adhesion and filling in by “on-growth” tissues engages the structure of the bone and projects or transfers true shear stress away from the anchor 12 and out into the tissues farther away. It may also mechanically bond to the tissues grown onto the concavities and convexities of the texturing features.
Thus, in general, it is contemplated in a system and method in accordance with the invention that sintering, sputtering, casting, forging, printing, or other manufacturing techniques may be relied upon to provide not only through-apertures of any type (through tortuous paths of sintered grains of metal, for example, or formed as large open apertures 60 in walls or splines), or surface texturing along any surface (inside, outside, etc.) of an anchor. The healing by macrophages in the first days after a surgery (and implant) will thus provide additional resistance to pull out, in addition to such compressive loading provided by the nature of the helical splines radiating outward from an arcuate “centerline” of an anchor 12.
In addition to tensioning of the anchor 12 providing compression in the tissue, the anchor provides a friction lock and a fast developing shear-engagement lock of the anchor 12 in place. That is, the tension in the anchor 12 due to its committing to a curvature of its centerline, and then being forced to rotate along the path of its helical splines, results in a compression of tissues behind (considering insertion path direction to be forward) the anchoring splines 20. Meanwhile, those splines 20, or rather their texturing will shear and smear tissues forward, which then engage immediately by friction against pull out.
Healing then immediately begins to engage and lock in all that texturing, splines, and (apertures of every type) by intimate contact and growth filling concavities. Bone is a piezoelectric material. Any stress and consequent strain in the material induces a voltage. Any voltage applied to it induces a corresponding stress and strain. Bone healing occurs best in compression for exactly this reason. The compression maintains two adjoining pieces in intimate contact while the body detects the piezoelectric effect indicating stress and begins to remediate the stress by initiating growth.
Referring to
In
One will note that the illustration of
In
Thus, the cross section taken between the two ends, the point end 18 and the head end 16, shows the effective cross ends of the material in the splines 29, themselves, and the wall 23.
Referring to
Referring to
Comparing now the embodiment of
Referring to
An aspect ratio is simply the ratio of two dimensions. Accordingly, since an aspect ratio is one distance divided by another distance the aspect ratio has no units, that is, no dimensional name. An aspect ratio is a “dimensionless” number as well understood in the engineering arts and the technical arts of manufacturing and fabrication. In the illustrated embodiments, each of the anchors 12 includes or may be characterized by aspect ratios.
For example, the diameter of the lumen 22 compared to the diameter or outer diameter of the wall 23 is an aspect ratio of two diameters. Similarly, the diameter of the lumen 22 or the diameter of the wall 23 may be divided by the outer diameter around the splines 20 to determine yet another aspect ratio of comparative diameters. Similarly, lengths may be compared. For example, any of the foregoing diameters may be compared to the length of a particular anchor 12 thus defining an aspect ratio of diameter to length.
One will note that the aspect ratios may be reversed, such that length is divided by a particular diameter. One use of aspect ratios is to characterize a distance or a proportionality between dimensions of an object in the abstract, rather than specifying any particular set of measurements. In the physical arts of engineering, manufacturing, fabrication, and the like, these aspect ratios may be very useful.
Moreover, performance is often related to aspect ratios, “dimensionless” numbers characterizing an object. It is typically beneficial to define or characterize an object by an aspect ratio that effectively equals a smaller dimension divided by a larger dimension. In this way, the aspect ratio will vary between zero and one. It cannot exceed one where the longest dimension in the object is the deviser.
In
One will also note that certain embodiments illustrate apertures 24 or grow-through areas 24. For the sake of clarity, the lattice work 24 or porosity 24 is not illustrated in any of the
It has been found that support of the wall 23 or core 23 of an anchor 12 militates in favor of a lattice work 24 rather than comparatively larger (of the same order of magnitude as the distance circumferentially between splines), are less mechanically stable. Collapse, twisting closed, and the like may be problematic, depending on other dimensions. It has been found that grow-through areas 24 of the type illustrated in
Referring to
For example,
The image 16B shows a surface roughness that is quite irregular. In this embodiment, the edges tend to still be rounded, but the heights, the widths, and so forth (all dimensions) of the surface roughness 26 or texturing 26 are random. This is typically provided by a manufacturing technique known as sputtering. That is, random globules of molten metal may be attached to a base metal by a throwing by “sputtering” in which the material for texturing 26 is thrown as a liquid toward a heated surface and will secure, after splashing, and cooling. Likewise, such surface texturing may also be provided by sintering. Sintering is a process whereby a granular material may be packed into a mold, as distinct particles. The particles may then be heated until they partially melt, sufficiently to adhere to one another, but yet leaving porosity therebetween.
The image 16C is an alternative embodiment in which larger spaces or gaps may be left along the surface of a wall 23 by one of the foregoing methods, such as centering or sputtering. Typically, these processes result in a somewhat random distribution of texturing 26 of random dimensions.
Referring to
The image for 16E illustrates a smaller dimensionality, similar to the texturing 26 of the image 16A. Similarly,
One may note that the anchor 12 in general, does not necessary need an undercut texturing 26. This is because being surrounded by bone, typically cortical bone, the anchor 12 becomes encased and completely circumnavigated or circumscribed by the bone growth. Thus, any texturing 26 whatsoever becomes sufficient to prevent dislodgement or movement of the anchor 12 with respect to the subsequently grown bone growth.
Referring to image 16H or
For example, the splines 20 will typically have an “interference fit” as that term is used in the engineering, manufacturing, assembly, fabrication, and other technical arts. An interference fit means that the dimension of an outer or receiving cavity, surface, slot, path, or the like is less than the outermost dimensions of the item (e.g., a spline 20 or core 23 of an anchor 12), thus not an actual fit with a tolerance for clearance. Instead, one or both of the materials must provide a certain amount of “give.”
By the word give, is meant that either elastically, plastically, or by abrasion, one of the surfaces must displace in order to make the fit. Again, abrasion means wear, while elastically means still capable of full recovery of dimensions when any distorting force is removed. Plastically means that the material has “yielded.” Yielding means that the molecular structure or atomic structure of a material has permanently shifted, never to return to its former position. The term ‘yielding’ is a term of art that should be understood by any technician in mechanical or manufacturing arts.
Barbs 78 tend to move along a path during insertion or installation of an anchor 12 but will not return out of that path with the same amount of force applied. This is because the barbs 78 are slanted to glide forward in response to force axially applied to an anchor 12, but will immediately dig in to the surrounding material upon application of a force in an opposite direction. Thus, such anchors 12 with splines 20 having barbs 78 become immediately fixative and will not remove or move opposite to their direction of insertion with the same amount of applied force required to insert them. Barbs 78 may be used in other embodiments of surface texturing, but creating undercuts such as barbs 78 is difficult and therefore may limit the utility or availability of barbs 78 generally.
One will note various mechanisms combine to stabilize anchors 12. Texturing 26 may be applied to any particular surface. Those surfaces may be corrugated, shaped, convex, concave, undercut, through holes, blind holes, heavily (deeply) textured, roughened surfaces, regions perforated with grow-through areas 60 (GTA 60), splining, helical splining with very long pitch, and so forth.
Referring to
In accordance with the invention, a trocar 79 extends beyond the needle portion 81 to be the vanguard or phalanx of the Jamshidi needle 80. Thus, in this configuration, the Jamshidi needle 80 does not draw a biopsy, but simply forms an initial penetration for entry of the K-wire 84 of
Referring to
By laying the groove 96 or bed 96 of the gauge 90 against the K-wire 84, one effectively lays the K-wire 84 into the bed 96 leaving the blunt end 88 or base end 88 of the K-wire 84 lying at some point along the gauge 94. By reading the measurement of the gauge 90, one may then determine how much of the K-wire length is still outside the surgical subject, and how much has been inserted within. This provides an indication of the exact location along the path of the K-wire 84 and originally the Jamshidi needle 80 from the surface of the subject or skin of the subject. At this point, the gauge 90 may be set aside and the K-wire 84 may be relied upon as a guide 84 in subsequent procedural steps.
Referring to
However, as tissue stretches around the circumference and outer diameter of the small dilator 100a, although there may be trauma, incisions will not be required to cut through the tissue, unnecessarily severing neighboring tissue. Eventually, any tooling, mallet, or other device used on the shank 106 to drive the small dilator 100 forward will be removed and a large dilator 100b will be slipped over the shank 106 of the small dilator 100a. At this point, by force, pressure, or impact, the shank 106 of the large dilator 100b will be urged along the path now defined by the outer diameter of the small dilator 100a. Again, gauge marks 105 on the barrel 104 of the large dilator 100b provide a direct reading of the depth of penetration by the large dilator 100b. More is explained hereinbelow regarding the use and structure of the large dilator 100b.
Referring to
Thus, another small dilator 100d fixed through a mount 108 securing the shanks 106 of both the small dilator 100c and the small dilator 100d will require that the small dilator 100c penetrate parallel to the small dilator 100c, which is following the path already dilated by the small dilator 100a that was subsequently removed. It may be that a second K-wire 84 may be passed down through the second dilator 100d, but this need not be necessary. In some respects, a K-wire 84 may be used as a trocar 79 inside the lumen 98 of the small dilator 100d in order to assist the small dilator 100d in penetrating tissues that were not addressed by the Jamshidi needle 80.
It is a principal function of the twin dilator 100 of
Referring to
Thus, as the working portal 110 is moved axially along the length of the large dilator 100b, the handle 115 or grip 115 applies axial and circumferential force to the shank 106 or lug 106 of the working portal 110. Points 116 are typically engineered to penetrate into cortical bone in order to secure or fix the working portal 110 to the bone that is the subject of the installation or insertion of an implant 12, also called an anchor 12.
Upon contacting bone 14 of some type, according to the specific surgery, a working portal 110 may advance under a mallet providing an impact load on the shank 106 of the working portal 110 to fix the points 110 and into local bone 14 thereby stabilizing the working portal 110 in all dimensions of consequence. Axially, it abuts the bone 14. Radially, it is held by tissue, as well as by the points 116 against lateral motion in any radial direction. Similarly, the points 116 secure the barrel 114 of the working portal 110 against rotation with respect to the bone 14.
At this point in a procedure in accordance with the invention, the user, medical professional, is prepared to pass various tools 120, 130, 134, 140, and so forth into the working portal 110, and along the guide 84 that is the K-wire 84 still embedded in bone 14 at the center of the working portal 110.
Referring to
In the illustrated embodiment, the shank 124 is provided with a securement 125, here embodied as a groove such as may be used for a quick-connect mechanism for securing the drill 120 in an axial direction to a driver mechanism, well known and not shown. Meanwhile, a flat 125b may provide for engagement by a driver thereby assuring rotary motion by the driver. Thus, the engagement mechanism 125a or securement 125a acts to secure the drill 120 axially, while the flat 125b acts to provide rotary motion driven by a drive mechanism. The drive mechanism is not shown because such are available in the art as hand cranks, electrical motors, and the like.
Of note, are riders 126 on the shaft 121 of the drill 120. These riders 126 act as carriers 126 to center the drill bit 122 within the working portal 110. Meanwhile, the lumen 98 passing axially through the center of the bit 122 and shaft 121 also guides down a K-wire 84 in place for that purpose. The flutes 128 on the bit 122 are designed to cut and carry back any materials drilled out by the bit 122.
Likewise, the drill 120 may be withdrawn from a path, in order that saline or typical flush solution may be injected or introduced to irrigate the opening made by the drill bit 122 and wash away any resulting debris. One will note that the drill bit 122 is sufficiently long that it may drill through both bones in any crossing implementation and may drill along a cartilaginous joint in a parallel implementation. Thus, the flutes 128 may cut into soft tissue, marrow, cartilage, as well as cortical bone as required to establish the path that will eventually be followed by insertion of an anchor 12.
Referring to
The reamer 130 in the illustrated embodiment is sometimes referred to as a paddle reamer 130. It may have two, three, or more flutes 128 extending from it. Its function is to rotate to thereby clean out cartilaginous material soft tissue that may otherwise impede insertion of an anchor 12. Also, the reamer 130 may also tend to scrape against cortical bone in a parallel insertion configuration in order to provide “bleeding bone” for enabling bone growth around an inserted anchor 12 thus permanently fixing the anchor 12 and creating a solid, fixed relationship between the two bones 14a, 14b being anchored together.
Referring to
One will note that the angle or the circumferential progression of the splines 20 on the head 136 exactly match those of an anchor 12. Accordingly, the splines 20 of the head 136 may initially penetrate the diameter of the hole left by the bit 122 passing into or through bone 14. The broach may be instantiated in multiple versions, each broaching slightly more material out of the cortical bone 14. Alternatively, the various diameters of the head 136 may increase such that the cutting edges 132 and the head 138 may cut initially at one diameter, then subsequently at larger diameters until approaching, but typically not meeting the outer diameter of an anchor 12.
Meanwhile, the thickness of each spline 20 in the head 136 is best served by being slightly less than a thickness of a spline 20 in an anchor 12. In this way, an anchor 12 is inserted against the frictional clamping force of the interference fit in which the pathway formed by the broach head 136 is slightly undersized to fit the radial dimensions and circumferential dimensions of the anchor 12 and its splines 20.
Threads 137, along the shaft 121 may provide for adjustment by a grip 139 that acts as a contact surface 138 preventing further axial movement of the shaft 121 and broach 134 into the access portal 110 or working portal 110. Of course the riders 126 maintain centering, as does the K-wire 84 in the lumen 98 of the broach 134. Gauge marks 105 provide an immediate feedback as to the positioning of the contact surface 138 that will eventually contact the shank 106 of the working portal 110, limiting the penetration of the broach 134 and head 136 into the surgical path.
In certain embodiments, the handle 139 may be engaged with an internal spiraling path that instead rotates and advances the shaft 121 at exactly the rate required by the splines 20 of the broach head 136. The broach 134 may typically be operated by a hand tool secured to the shank 124. Thus, a user can work the broach 134, much as a rasp in order to provide forward axial force on the head 136, as well as urging a rotational force along the direction of the splines 20 in order to cut through the bone 14 in a path suitable for receiving the anchor 12 later. Following broaching, the broach 134 is removed, and the path or cavity may be flushed to remove any debris, in preparation for insertion of an anchor 12.
Referring to
Referring to
Insertion 153 of a Jamshidi needle 80 then occurs, followed by removal 154 of the trocar 79. This is followed by inserting 155 a K-wire 84 through the shaft 81 of the Jamshidi needle 80, ultimately securing the point 86 or other portion of the K-wire 84 into bone 14. The K-wire 84 may actually penetrate through and beyond the anchoring site. For example, the K-wire 84 may move past cortical bone, cancellous bone, more cortical bone, and on into soft tissue. The K-wire 84 may define a path that extends beyond the insertion of the point 18 or leading edge 18 of the actual anchor 12 inserted. One reason for this is that bone graft material may be added.
Once the K-wire 84 is properly inserted 155, removal 156 of the Jamshidi needle 80 can be done. Next, inserting 157 the small dilator 100a is done, followed by a decision 167 as to whether a new second, parallel, path is to be created, as described hereinbelow. If not, then insertion 158 of the large dilator 100b follows. The working portal 110 is next inserted 159, sliding over the outer diameter of the shaft 105 of the large dilator 100b. Once the working portal 110 is inserted 159 and anchored as discussed hereinabove, a user may remove 160 both the dilators 100a, 100b and gauge 161 for drilling 162. The gauge 90 with the K-wire 84 laid into the bed 96 may provide a gauging mechanism 94 for determining exactly how deeply into the path the drilling 162 needs to progress.
At this point, the next alternative in the procedure depends on the decision 163, whether the anchoring is across the bones 14a, 14b, or between the bones 14a, 14b (that is, along and inside the joint 15). If the anchoring is to be into the joint 15 (what we will call parallel to cortical surfaces, not parallel anchor paths, although the cortical surfaces are more tangential, not planar). Reaming 164 occurs, in the “inside joint” or “parallel to cortical surfaces” case. In either the cross or the parallel configuration, broaching 165 occurs, both as described hereinabove. Inserting 166 the anchor 12 using the insertion tool 140 results in the anchor 12 being fixed into place. Installation is thereby completed 158
In other words, if the decision 163 indicates a cross orientation across the joint 15 between, that is from one bone 14a to another bone 14b, then broaching 165 may proceed directly after drilling 152, and followed by anchoring 166 or inserting 166 an anchor 12. Note that the anchor 12 rotates as it moves forward into place, as a result of the helical path of the splines passing through the cortical bone as broached 165. The insertion tool may be urged rotationally in order to relieve the load on cortical bone carrying the splines 20 as they helically progress into, through, across, or along the bones 14a, 14b.
Going back now to the decision 167, if a new anchor, 12 parallel to the original K-wire 84 and small dilator 1001, is desired, then one may need to remove 169 the initial small dilator 100a and insert 170 the twin dilators 100c, 100d. Inserting 170 the twin dilators 100c, 100d, a second K-wire 84 may be inserted 171, followed by withdrawing 172 the dilator, and returning to the process 150 at the step of inserting 151 two small dilators 100a down those two parallel paths before proceeding.
Referring to
Subsequently, the drill 120 is employed to drill through the bone 14, followed by a reamer 130 in order to clear out loose cartilage, any other loose materials, as well as scoring or abrading part of the cortical bone if necessary. That is, for example, the reamer 130 may be as important as the drill 120, since the reamer 130 makes the path for the anchor 12 to pass. A broach 134 may be employed to cut a path into cortical bone for passage of the splines 20 of the anchor 12. Ultimately, the insertion tool 140 is employed in the working portal 110 to insert the anchor 12.
At any point before, after, or during insertion of the anchor 12, any significant spaces remaining may be filled with bone graft material, typically allograft, autograft, or homograft. This typically includes small particles of bone to aid in the early healing and growth through any available spaces by natural bone. Following insertion of all anchors 12, the working portal 110 may be withdrawn, and proper suturing may be done to close the wound.
When inserting anchors 12 across through one bone 14 into another bone 14, the Jamshidi needle 80 begins the process, followed by insertion of a K-wire 84. A small dilator 100a may be implemented, but the twin may also be used at this point. However, it is more common that following insertion of the small dilator 100a in the process of
The large dilator 100b is thus passed over the small dilator 100a, followed by the working portal 110 being fitted over and forced into place. Again, the working portal 110 anchors to the bone 14 and the dilators 100a, 100b may be removed.
Accordingly, the drill 120 may be implemented as described hereinabove, followed by the broach 134. It is worth noting that broaching is optional, it is not always required. Nevertheless, due to the comparatively brittle cortical bone, meaning that cortical bone will fracture in response to force much more quickly than will cancellous bone or soft tissues, which may displace and even damage traumatically, but do not necessarily chip away as the general mechanical fracturing of cortical bone. Thus, the broach 134 has a very useful function, but in some instances may be unnecessary.
Of course the processes 150 may be repeated for multiple anchors 12 in multiple locations in an SI-joint fixation. Herein, a diameter of an anchor or any other article or component means the diameter of a circle circumscribing the anchor, other article, or component. Effective diameter means “hydraulic diameter,” which is four times the cross-sectional area divided by the perimeter (typically called “wetted perimeter,” the fluid contact perimeter when applied to a solid-fluid interface, interior or exterior to the solid). One will see that effective diameter becomes the regular diameter for a circular shape, and the length of a side for a square shape. For other shapes, especially irregular shapes, the effective diameter is some other value, but useful in various fluid-related calculations.
Referring to
Referring to
Of course, given the equipment and processes illustrated and described in
For example, rather than requiring both circumferential rotation and axial translation of an anchor 12 as it enters a bone 14a, 14b or joint 15 via an opening broached and drilled for the purpose, straight splines 20 simply translate in a single axial direction of the anchor 12. This results in lower immediate pullout strength upon application or insertion of the anchor 12 into bones 14 across a joint 15 or into (approximately parallel, more or less) a joint 15. However, it is beneficial in that an allograft, autograft, or homograft bone anchor 12 may begin immediately to heal and join surrounding bone tissue.
This stands in contrast to metal, such as titanium, anchors 12, which are typically treated by a body as inert foreign materials. That is, bone material will grow through, on, and around inert (non-reactive) metallic materials of which anchors 12 may be made. So straight anchors 12 with straight axial splines 20 may be formed of metal as described hereinabove. However, metal is much more robust than bone material, both in strength and toughness as those terms are used in mechanical engineering technology. Thus bone material does not serve as well as metal in the various helical configurations discussed hereinabove.
However, one advantage of using bone materials for anchors 12 is the rapid incorporation (e.g., healing) of the anchor 12 into the bones 14 themselves. The various example lengths and proportions of anchors 12 in
In contrast, crossing through a joint 15, where the bones 14 themselves are on opposite sides of the joint 15 in comparatively close proximity (even in contact), an anchor 12 traverses across a comparatively shorter distance. An anchor 12 such as that shown in
Meanwhile,
The procedures illustrated in the processes and equipment of
Referring to
For example, having a tapered (ramp-like) surface along the wall 23 near the base end 16 may urge the anchor 12 axially backward (away from the point 18) out of the space prepared for it. That is, natural bone, in the absence of any helical surfaces to resist any tendency of an anchor 12 to back out, may preferably have a single outer diameter for the wall 23 or core 23 at all locations axially behind the taper at the point end 18.
In certain contemplated embodiments, the splines 20 may be substantially perpendicular to the outer surface of the wall 23 of the anchor 12. On the other hand, filleting is a manufacturing method to reduce stress, stress concentration factors, and susceptibility to fracture (as defined in engineering technology and fracture mechanics usage) by specifying and forming a specific radius to span a corner. Thus, it is currently contemplated as a best practice to provide rounded edges at both internal and external corners in the cross sections of
Meanwhile, fillets may be specified at several thousandths (typically 0.005 to 0.020 in., 0.1 to 0.5 mm) of an inch radius in the corner where each spline 20 meets the surface 23. Of course, allograft, autograft, or homograft bone will be an integral material in the wall 23 or core 23 and all the way throughout the splines 20 extending therefrom. Each anchor 12 must be of suitable size (length, outer diameter of wall 23, outer diameter of splines 20) to accomplish its function. Thus, five splines 20 may be ideal for many reasons from manufacture to installation, especially if buttressed (trapezoidal cross section). For grow-through openings 24, the number of splines 20 should be an even number for symmetry. Thus, four splines 20 as in
In certain embodiments, a more trapezoidal shape for the splines 20 may provide a broader base or thicker base than the thickness of the spline 20 at its outer diameter. Buttressing may thus relieve stress concentrations that might otherwise develop at the junction between the splines 20 and the wall 23 or core 23. Reducing stress concentrations, and thereby stress concentration factors, as those terms are used in engineering technology, can greatly improve the strength in service and especially the strength and resistance to impact loading when an anchor 12 may be malleted into place.
The anchors 12 of
The tendency of the receiving bones 14 to compress under load from a spline 20 but relieve into the undercut portion associated with a barb 78. This allows expansion or relief of the receiving bones 14 into the undercut corresponding to the barb 78. This interference of the base bones 14 into the undercut adjacent the barbs 78 provides a shear support or a shear force into the spline 20 in an axial direction, opposite the direction of insertion.
The configurations of
Buttressed splines 20 may be wider near their connection (transition, since they are machined from a single piece, not assembled) to the core 23 than at their outer perimeter (i.e., outer diameter, outer circumference). In practice, the equipment and processes of
Likewise, while applying a broach 134 to form grooves suitable to receive straight splines 20 (lands 20), rotation of the broach 134 is unnecessary. Thus, the illustrations of
Referring to
Referring to
Meanwhile, the vertical (z) direction or the directions of the superior 11a and inferior 11b illustrations represent the direction perpendicular to a horizontal plane. Each of these directionalities represent a degree of freedom. That is, an object movable in space may move in translation “literal and linear movement in the direction of any of the x, y, z axes.” However, an additional three degrees of freedom are the rotational directions about each of those axes. In the illustrations, an x axis is represented by the directions 11c and 11d. A y axis is illustrated by the directions 11e, 11f. Thus, a z axis or z direction is represented by the directions 11a, 11b, all of which have been described previously hereinabove.
Thus, the anchors 12a above and 12b below or either of those along with an anchor 12c would fix the bones 14a, 14b from translating or rotating in the y-z plane represented by directions 11e, 11f and 11a, 11b, respectively. However, those anchors 12a, 12b, 12c or some combination of any two thereof provide very limited resistance to movement of the bones 14a, 14b axially along any anchors. For example, toward and away from each other in the x direction illustrated by axes or directions 11c, 11d. This additional degree of freedom in the x direction 11c, 11d may be remediated by various methods.
One such method is to provide some fixation in a z direction 11a, 11b passing between the sacrum 14a and ilium 14b. An alternative way to stabilize lateral and medial 11c, 11d motion is to place an anchor 12d in the joint 15 itself.
The anchors 12d, 12e represent a different fixation method or a slightly augmented fixation method. First, either would provide an engagement (think “land and groove” or “tongue and groove” fit) and resulting compression (radially with respect to anchor 12) against the bones 14a, 14b in (within) the joint 15. As discussed hereinabove, the deterioration of the joint 15 typically involves destruction of cartilage, bone, and typically some of both in the joint 15 (making up the joint 15). Ligaments outside and crossing the joint normally pull the bones 14a, 14b together. Deterioration of the joint destroys tissues connecting the bones 14a, 14b therebetween, relieves that necessary tension. Ligaments on the surfaces of the bones 14a, 14b pulling or drawing the joint 15 together can become slack. Thereby, the joint 15 becomes ineffective because the bones 14a, 14b can move uncontrollably (to some degree in all directions 11a-11f) with respect to one another, grating “bone 14a, 14b on bone 14b, 14a.”
The ligaments may therefore need to be re-tensioned by one or more anchors 12 within the joint 15 exerting compressive force (radially outward from the anchors 12) against the bones 14a, 14b on each side of the joint 15. By placing an anchor 12d in the joint 15, it anchors its splines 20 into the bones 14a, 14b, but also forces those bones 14a, 14b apart, thereby tensioning the ligaments holding the bones 14a, 14b together. The combination of the anchor 12d pushing and the ligaments pulling, the positioning of the bones 14a, 14b across the joint 15 (approximately in the lateral-medial directions 11c, 11d) is fixed (rendered effectively rigid).
With multiple anchors 12 (typically two or more of anchors 12a-12e in
Of note also, as seen in
An anchor 12e (shown on the left side of the body, for clarity, although it may be mirror imaged on the right side), is directed along no principal direction 11a-11f, nor any principal plane corresponding thereto. However, any direction, such as that of anchor 12e, may be resolved into components contributing thereto from the principle directions 11a-11f. Thus, any anchor 12 inserted to stabilize or fix the joint 15 may be in any suitable direction resisting and intending to preclude (that is, obstruct, intending to halt), any motion of the bones 14a, 14b with respect to one another in that direction 11a through 11f.
Thus, an anchor 12 inserted “into” a joint 15 means directing it in a suitable direction between the bones 14a, 14b to accomplish a forcing apart of the bones 14a, engagement of the anchor 12 with them (digging into surfaces of bones 14a, 14b), with corresponding tensioning of the ligaments connecting the bones 14a, 14b. Meanwhile, speaking of any anchor 12 across or “through” the joint 15 means crossing (in the axial direction of the anchor 12) from within one of the bones 14a, 14b across the joint 15 into the other bone 14b, 14a.
An anchor may similarly be placed in any direction that has a component direction 11a through 11f suitable for fixing other anchors 12 (thus introducing a significant perpendicularity) against movement along their axial directions (vector combinations of contributions in principal directions 11a-11f and rotations thereabout). Meanwhile, total force contributions in each of those principal directions (11a-11f and rotations therearound) supported by anchors 12 should be sufficient to restrict motion normal (perpendicular) to a centerline 17 of each anchor 12. Restriction should be as close to zero motion as possible or practical, meaning therapeutically necessary to promote permanent fixation by virtue of eventual bone growing together.
The present invention may be embodied in other specific forms without departing from its purposes, functions, structures, or operational characteristics. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
What is claimed and desired to be secured by patent is:
This application: is a continuation-in-part of U.S. patent application Ser. No. 18/222,441, filed Jul. 15, 2023; which is a continuation-in-part of U.S. patent application Ser. No. 16/838,827, filed Apr. 2, 2020 scheduled to issue as U.S. Pat. No. 11,701,238 on Jul. 18, 2023; which is a continuation-in-part of U.S. patent application Ser. No. 16/263,405, filed Jan. 31, 2019, issued as U.S. Pat. No. 10,898,345, issued on Jan. 26, 2021; which is a divisional application of U.S. patent application Ser. No. 15/380,048, filed Dec. 15, 2016, issued as U.S. Pat. No. 10,195,051 on Feb. 5, 2019; which is a divisional application of U.S. patent application Ser. No. 15/001,502, filed Jan. 20, 2016, issued as U.S. Pat. No. 9,539,110 on Jan. 10, 2017; which is a divisional application of U.S. patent application Ser. No. 13/937,208, filed Jul. 8, 2013, issued as U.S. Pat. No. 9,248,029 on Feb. 2, 2016; which is a continuation of PCT Application Serial No. PCT/US2012/020560, filed Jan. 6, 2012; which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/430,296, filed Jan. 6, 2011. This application also claims the benefit of U.S. Provisional Patent Application Ser. No. 63/527,017, filed Jul. 15, 2023 and U.S. Provisional Patent Application Ser. No. 63/559,822, filed Feb. 29, 2024. All the foregoing references are hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61430296 | Jan 2011 | US | |
| 63527017 | Jul 2023 | US | |
| 63559822 | Feb 2024 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15380048 | Dec 2016 | US |
| Child | 16263405 | US | |
| Parent | 15001502 | Jan 2016 | US |
| Child | 15380048 | US | |
| Parent | 13937208 | Jul 2013 | US |
| Child | 15001502 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2012/020560 | Jan 2012 | WO |
| Child | 13937208 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 18222441 | Jul 2023 | US |
| Child | 18771950 | US | |
| Parent | 16838827 | Apr 2020 | US |
| Child | 18222441 | US | |
| Parent | 16263405 | Jan 2019 | US |
| Child | 16838827 | US |
