Patent Application
20180338786
Hammertoe is the most common deformity of the lesser toes and is characterized by an abnormal flexion posture of the proximal interphalangeal (PIP) joint of at least one of the lesser toes, which gives the affected toe a bent, claw-like appearance. The factors contributing to hammer toe are difficult to determine. Women are more commonly affected, and the incidence of the deformity increases with age. Though diabetes, connective tissue disease, and trauma are identified as predisposing factors, the long-term use of poorly fitting shoes, especially those with a tight toe box, is generally thought to be a primary cause of the condition. The resulting crowding and overlapping of the toes while wearing the shoes may lead to either flexible deformities, which can be passively corrected to a neutral position, or fixed deformities, which cannot be passively corrected.
In addition to having cosmetic complaints about the hammer toe, patients with the deformity also commonly experience pain on the dorsum, or top side, of the PIP joint, where a corn typically develops from the pressure that the poorly fitting shoe exerts on the toe. Painful calluses may also develop at the distal end of the affected toe or beneath the metatarsal head. Other underlying conditions, such as diabetes, may cause ulceration and possibly infection to develop at these areas of pressure, further complicating treatment and endangering the toe or foot.
Several different treatment options exist for hammer toe, with varying degrees of success. For flexible deformities, a physician may prescribe more conservative passive treatment, such as stretching the toe, taping the toe, soft shoe inserts, or shoes with wider toe boxes. However, these treatments are generally disappointing, with recurrence of the hammer toe likely once the treatment stops. Most patients with symptomatic hammer toe, as well as those with a fixed deformity, will require surgical treatment. Soft-tissue procedures alone, such as flexor-to-extensor tendon transfer, may not lead to permanent correction and are not appropriate for all patients. Thus, bone and joint procedures are more commonly used to surgically correct hammer toe.
Resection and arthrodesis of the PIP joint are among the most common surgical procedures for treating very rigid deformities or when additional joint stability is needed. Arthrodesis alleviates pain by promoting fusion of adjacent bones at the joint. Fusion can be accomplished using K-wires, orthopedic screws, or plates. However, a straight fusion usually looks unnatural, as a degree of flexion is normal at the PIP joint. Better options for PIP fusion are needed to meet patients' needs.
Traditionally, K-wires have been the most common means for completing bone fusion procedures. However, K-wires have several drawbacks. Bone fusion by K-wire involves placing the toe in the correct anatomical position and then driving the K-wire through both bones and the joint to hold them in place. Part of the K-wire protrudes out of the tip of the toe to facilitate removal of the K-wire several weeks later. This aspect of the procedure greatly increases the risk of infection, in addition to requiring multiple dressing changes and limiting ambulation. Other complications that commonly arise with the use of K-wires include K-wire migration, loss of fixation, misalignment, nonunion, swelling, and inflammation.
Recently, hammer toe implant devices have become more popular for fusion procedures. These devices may be composed of various biocompatible metal or thermoplastic materials and remain in the toe, providing increased stability. However, common complications that are associated with these devices include bony regrowth, prolonged edema, limited range of motion, poor toe purchase, and the need to remove the implant in certain situations. Furthermore, these devices typically have a linear shape, leaving the bones fused in an unnatural, straight conformation. Thus, there presently exists a need for fusion devices that avoid these many complications, while providing the patient with a natural degree of flexion in the corrected toe.
Embodiments of the invention are directed to an improved implantable bone fusion apparatus for proximal interphalangeal (“PIP”) fusion. Embodiments of the invention presented herein may be used in flexed or jointed bone fusion applications. In a flexible bone fusion application, an embodiment of the invention is directed to a bone fusion apparatus comprising an anchor portion having an elongated body with screw threads on at least a portion of its exterior, the anchor having a leading tip and an end; a compressor portion having an elongated body with screw threads on at least a portion of its exterior; and a coupler having a first end adapted to rotatably engage the anchor in a first plane, the coupler also having a second end adapted to rotatably engage the compressor through axial rotation.
Driving tools including a delivery tool and a compressor tool are provided for installing and then compressing the bones together, respectively. One embodiment is a two-part tool for driving or compressing a flexible bone fusion apparatus having a coupler portion, an anchor portion and a compressor portion, comprising a shaft portion and a separate handle portion, the shaft portion comprising a delivery shaft and two adjoining loading shafts at each end of the delivery shaft, the loading shafts adapted to couple with the handle portion and at least one driven or compressed component, each loading shaft having a driving pattern on its external surface that is complementary to a driving pattern on an internal surface of a lumen in one end of the driven or compressed component; and the handle portion having at one end a lumen adapted to receive the loading shaft of the shaft portion, the lumen having a driving pattern on its internal surface that is complementary to the driving pattern on the loading shaft.
Another embodiment of the invention is directed to a bone fusion apparatus comprising an anchor portion having an elongated body with screw threads on at least a portion of its exterior, the anchor portion having a leading tip and an end, the anchor end adapted to rotatably engage a compressor portion through axial rotation; and a compressor portion having an elongated body with screw threads on at least a portion of its exterior, the compressor portion having a leading tip and an end, the compressor end adapted to rotatably engage the anchor end through axial rotation. The bone fusion apparatus further comprises a snap-fit interface where the compressor end and anchor end join, thereby eliminating the coupler portion of the first embodiment. The bone fusion apparatus anchor end may also comprise a coupling end, and the compressor end may also comprise a lumen having annular grooves adapted to receive the anchor coupling end. The bone fusion apparatus may also be modified wherein the anchor coupling end is angled relative to the anchor, thereby facilitating the fusion of adjacent bones ends at an angle, without having a flexible coupler between the anchor and compressor.
Embodiments of the invention are further directed to a flexible bone fusion apparatus comprising:
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the coupler has an anchor end and a compressor end, the anchor and coupler sharing an interface at which they may rotate in a first plane, the coupler and compressor sharing a second interface at which they rotate axially.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the compressor portion further comprises a lumen running the entire length of the compressor.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein when assembled the anchor and coupler share separate portions of an attachment assembly comprising an interlocking anchor attachment portion and a compressor attachment portion.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the anchor attachment portion comprises at least one locking wedge, at least one semi-circular conical face and at least one semi-circular annular groove.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the coupler attachment portion comprises at least one locking wedge, at least one semi-circular conical face and at least one semi-circular annular groove.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the compressor lumen is adapted to engage a delivery tool through a driving pattern.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the compressor lumen driving pattern comprises an octagonal cross-section having eight ridges.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the coupler and compressor are joined by a snap-fit interface comprising at least one annular ridge in either the compressor or coupler but not both, and at least one annular groove in either the coupler or compressor but not both, the snap-fit interface adapted to allow relative axial rotation of the compressor and coupler.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the compressor comprises at least one annular groove located in its lumen and the coupler comprises at least one annular ridge located on its external diameter.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the snap-fit interface has at least one expansion slot cut through either the compressor body or coupler body or both.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the screw threads of the anchor and compressor are synchronized to provide a continuous thread pitch from anchor to compressor.
Embodiments of the invention may also be directed to the flexible bone fusion apparatus wherein the first plane rotation direction varies from about 0° to about 30° when fixed in final position.
Embodiments of the invention are also directed to a method of fusing two adjacent bone ends using the flexible bone fusion apparatus by reversing the axial rotation of the compressor until the bones or bone fragments touch.
Embodiments of the invention may also be directed to a bone fusion apparatus comprising:
Embodiments of the invention may also be directed to the bone fusion apparatus further comprising one or more slots cut through the compressor portion thereby allowing for expansion of the compressor as the anchor is being inserted into the compressor lumen.
Embodiments of the invention may also be directed to the bone fusion apparatus wherein the anchor coupling end is angled relative to the anchor body.
Embodiments of the invention may also be directed to the bone fusion apparatus wherein the compressor lumen comprises at least two annular grooves and the anchor coupling end comprises a like number of annular ridges spaced so as to mate with the annular grooves thereby providing a snap-fit interface.
Embodiments of the invention may also be directed to the bone fusion apparatus wherein the compressor lumen driving pattern is adapted to engage a compressor tool through a complementary driving pattern.
Embodiments of the invention may also be directed to the bone fusion apparatus wherein the compressor lumen driving pattern comprises an octagonal cross-section having eight ridges.
The various embodiments of the present invention provide a system, including methods, apparatus and kits for connecting bones and/or bone portions using a multi-part bone connector with one or more rotating joints. One problem in the art being addressed by the embodiments of the present invention is that of fusing two bones or fragments of a single bone that need to be fused in a non-linear manner, e.g., fusion of the proximal and medial phalanges, or of the proximal and medial phalanges in the foot in an aligned but slightly fixed angle. Fusion of the proximal interphalangeal (“PIP”) joint in the hand to alleviate pain associated with Rheumatoid arthritis is a typical application, or to alleviate the condition known as “Hammertoe” in the foot. A first embodiment of a flexible bone fusion apparatus comprises an anchor portion having an elongated body with retaining elements, typically screw threads, on at least a portion of its exterior, the anchor having a leading tip and an end. The anchor is the leading part of the multi-part bone fusion apparatus and in a PIP application the anchor portion of the apparatus is driven into and resides permanently in the medullary cavity or canal of the proximal phalange. The anchor works in combination with a second component called the compressor portion, which similarly has an elongated body with retaining elements that are typically screw threads that may be but are not necessarily of the same pitch and diameter as those of the anchor. In a PIP application, the compressor portion is separately installed into the medial phalange. There are two separate methods of installation. In a first embodiment the anchor-only is installed into the proximal bone, followed by a compressor-coupler combination in the medial bone. In this embodiment of the bone fusion apparatus, the flexible coupler has an interface at each end for interfacing with the anchor and compressor, respectively. In one embodiment the coupler has a first end adapted to rotatably engage the anchor in a first plane with one degree of freedom. The first plane is defined by the two-component rotating attachment assembly shared between the coupler and the anchor. The coupler at its other end (“second end”) engages the compressor which is adapted to rotatably engage the compressor through axial rotation. In one embodiment this is accomplished through a ridge-and-annular groove arrangement wherein the coupler shaft snaps into and is longitudinally retained by the compressor, yet they are free to rotate 360 degrees relative to each other around their mutual axis. This allows axial rotational freedom between the coupler and the compressor body which enables compression of the proximal and medial phalanges when the compressor is rotated in reverse. “Axial rotation” is rotation about a transverse axis of the anchor and/or compressor portions as depicted by the rotating arrow in
An advantage of this embodiment is that the anchor-coupler attachment region allows rotation in a single plane only, and then is locked in flexed position by counterclockwise rotation of the compressor which pulls the anchor and compressor away from each other thereby locking the flexed orientation. This single-plane limitation is an advantage over prior art apparatus that allow for multiple degrees of freedom, thus allowing unwanted flex off the desired axis during the early healing phase.
The terms “anchor,” “anchor portion,” “anchor element” or “anchor component” are used interchangeably to mean the leading component of a two- or three-component bone fusion apparatus described and taught herein. The second or trailing anchoring element is called by the interchangeable terms “compressor, “compressor portion,” “compressor element” or “compressor component.” The anchor portion and compressor portion both function as bone anchoring devices. Bone anchoring devices are well-known in general and can take many forms. The anchor components may include two or more discrete anchor elements that can engage bone to resist removal of each anchor element. Each anchor element may be unitary (one piece) or may be formed of two or more pieces, such as two or more pieces that are affixed to one another. The flexible bone fusion apparatus also may include one or more other discrete components, such as one or more discrete spacer components disposed between the anchor elements and/or one or more end components flanking the anchor elements adjacent one or both opposing ends of the connector.
The anchor elements may have any suitable size and shape. The anchor elements may be about the same length (the characteristic dimension measured parallel to the central axis) or different lengths. For example, the compressor element may be shorter or longer than the anchor element. The anchor elements may have about the same diameter or different diameters. The diameter of each anchor element may be generally constant or may vary along the length of the anchor element. For example, the anchor element may taper distally, proximally, or both. Furthermore, the anchor element may have a distal tapered nose (threaded or nonthreaded) that enters bone first.
The flexible bone fusion apparatus may include a spacer region. The spacer region may have any suitable position(s) in the bone fusion apparatus and/or within an anchor element relative to a retention mechanism of the anchor element. For example, the spacer region may be disposed between a threaded region and a flexible joint of an anchor element. The spacer region may be unitary with an associated threaded region (or other retention structure) of an anchor element or may be formed by a distinct component joined fixedly (e.g., welded, bonded, or threadably coupled) or connected movably (e.g., coupled by a movable joint) to the threaded region (or other retention structure). The spacer region(s) may have any suitable length relative to the threaded region (or other retention structure) of an anchor element, including shorter, longer, or about the same length as the threaded region (or retention structure). Furthermore, the spacer region may have any suitable diameter or width relative to the threaded region (or retention structure) and/or protuberance, including a lesser (or greater) diameter or about the same diameter as that of the diameter of the threaded region. The spacer region may, for example, provide a nonthreaded region (and/or a non-anchoring portion of an anchor element(s)) to be disposed at the interface between bone members in which the flexible bone fusion apparatus is installed and/or may help define a range of bending motion of the flexible joint.
The bone fusion apparatus may define any suitable size and shape of lumen or cavity for any suitable purpose. The lumen may extend the entire length of the flexible bone fusion apparatus, such that the apparatus is cannulated, or may, for example, terminate before or after the lumen reaches the leading anchor element and before it reaches the leading end of the flexible bone fusion apparatus. The lumen may have a constant or varying cross-sectional geometry, which may be constant or vary within or compared between anchor elements. In some examples, the lumen may define a driver or delivery tool pattern in both anchor elements, so that a driver may extend through the trailing compressor element and into the leading anchor element, for concurrent engagement and rotation of both anchor elements. In some examples, the lumen may define a driver or delivery tool pattern in both the compressor element and an intervening flexing joint so that a driver may extend through the trailing compressor element and into the intermediate flexing joint, for concurrent engagement and rotation of both compressor and joint elements. In some examples, the lumen may narrow (or end) as it extends distally into the leading anchor element, to provide a shoulder for a tip of the driver to bear against, to facilitate driving the anchor into bone.
The terms “anchor-coupler interface” and “conical two-part single-plane interface” “attachment assembly 20” are used interchangeably to refer to the flexible joint assembly defined by the coupler-anchor interface of one of the present embodiments. The attachment assembly 20 is defined by the two attachment portions 21 and 22 shown in the figures. The word “flex” is used in the same manner as the term “bend” and is intended to convey a non-linear arrangement of the anchor and compressor portions.
Each anchor element may have any suitable retention mechanism. The anchor element may include a retention mechanism that is actuated by placement into bone and/or after placement into bone. The anchor elements of a flexible bone fusion apparatus may have the same type of retention mechanism (e.g., each having an external thread) or may have different types of retention mechanisms (e.g., one having an external thread and another having a nonthreaded engagement with bone).
A retention mechanism that is actuated by placement into bone may be defined by an anchor element that has a cross-sectional dimension (such as diameter) that is larger than the diameter of a hole into which the anchor element is placed. The anchor element thus may be disposed in a friction fit with bone (and/or may cut into bone) as it is placed into the bone. In some examples, the cross-sectional dimension may be defined in part by one or more projections that extend laterally from the body of the anchor element. Exemplary projections may include an external thread, one or more barbs, one or more circumferential ridges, one or more hooks, and/or the like. The projections may be biased (e.g., angled toward the trailing end of the anchor element), to facilitate insertion and to restrict removal. Alternatively, or in addition, the anchor element may have a cross-sectional dimension that increases toward an end (such as a trailing end) of the anchor element (e.g., a flared (e.g., frustoconical) anchor element). Anchor elements that engage bone and resist removal as they are placed into bone may be driven into bone rotationally (e.g., threaded into bone) and/or translationally (e.g., hammered into bone).
A retention mechanism that can be actuated in situ after placement of an anchor element into bone may be provided by expansion/deformation of the anchor element at a selected time after placement. The expansion/deformation may be any change in the structure of the anchor element that increases a cross-sectional dimension of the anchor element at one or more (or all) positions along the placement axis (e.g., the long axis) of the anchor element.
The flexible bone fusion apparatus may be configured as a bone screw having one or more anchor elements (“screw elements”) with an external thread. The external thread may have any suitable thread structure. Each screw element may include a single thread (e.g., a continuous rib and/or furrow) or a plurality of threads. The plurality of threads may be disposed in discrete axial regions of the screw element (e.g., spaced proximal and distal threaded regions on the screw element) and/or may share the same axial region (e.g., to produce a multi-threaded configuration). The thread (or threaded region) of each screw element may extend over any suitable portion of the screw element's length, including at least substantially the entire length or less than about half the length, among others. The screw elements preferably have a thread of the same pitch to avoid creating more than one thread channel in the bone, thereby potentially weakening the bone or lessening the ability of the threads to be retained by the bone. The thread may have any other suitable features. For example, the thread (and thus the corresponding screw element) may have a constant or varying major and/or minor diameter within a screw element and/or between the screw elements.
In some embodiments of the flexible bone fusion apparatus, the screw elements, and particularly the leading screw element, may be configured to be self-drilling and/or self-tapping as the bone screw is advanced into bone. For example, a leading tip region of the leading anchor element may include a cutting structure(s) to drill bone, and/or a threaded region of either or both screw elements may include a tap region (such as one or more axial flutes, thread notches or tap faces among others) with a cutting edge(s) to tap bone.
The flexible coupler portion has two ends, one of which interfaces with the anchor and one of which interfaces with the compressor. There are two separate and independent interface designs disclosed herein: one is a snap-fit type interface which allows 360 degree axial rotation of one component relative to the other. The other interface is a two-part conical design which only allows rotation through a single plane from approximately 0 to 30 degrees in either direction. In the embodiments disclosed herein, the design choice made was to locate the snap-fit interface at the compressor-coupler interface. Thus by default the two-part conical interface is located at the anchor-coupler interface.
The anchor elements of the flexible bone fusion apparatus may be connected by interfaces or joints suitable to provide the necessary motion. The joints may be movable between the anchor elements, operating by relative sliding motion (pivotal and/or translational) of apposed joint constituents. The joints may also rotate relative to each other. The joints may operate to restrict complete separation of the anchor elements in the absence of bone, while permitting relative rotational and/or translational motion of the anchor elements. The joints may be a composite connection formed collectively by two or more distinct movable joints.
The joints may permit any suitable relative motion. The joints may permit axial translational motion and/or lateral translational motion, or may substantially restrict either or both of these motions. The joints also or alternatively may permit rotational motion about the long axis and/or about one or more transverse axes of the flexible bone fusion apparatus. The rotational motion about the long axis may be unrestricted (allowing full turns) or restricted to less than a full rotation of the anchor elements. The rotational motion about the transverse axes may be determined by the structure of the rotational joint and/or joint constituents, for example, allowing an angular range of motion, about a selected transverse axis, of at least about 0 degrees and/or no more than about 10, 20, 40, or 60 degrees, among others.
The components may be formed of any suitable biocompatible and/or bioresorbable material(s). Exemplary biocompatible materials include (1) metals (for example, titanium or titanium alloys; alloys with cobalt and chromium (cobalt-chrome); stainless steel; etc.); (2) plastics (for example, ultra-high molecular weight polyethylene (UHMWPE), polymethylmethacrylate (PMMA), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), and/or PMMA/polyhydroxyethylmethacrylate (PHEMA)); (3) ceramics (for example, alumina, beryllia, calcium phosphate, and/or zirconia, among others); (4) composites; (5) bioresorbable (bioabsorbable) materials or polymers (for example, polymers of alpha-hydroxy carboxylic acids (e.g., polylactic acid (such as PLLA, PDLLA, and/or PDLA), polyglycolic acid, lactide/glycolide copolymers, etc.), polydioxanones, polycaprolactones, polytrimethylene carbonate, polyethylene oxide, poly-beta-hydroxybutyrate, poly-beta-hydroxypropionate, poly-delta-valerolactone, poly(hydroxyalkanoate)s of the PHB-PHV class, other bioresorbable polyesters, and/or natural polymers (such as collagen or other polypeptides, polysaccharides (e.g., starch, cellulose, and/or chitosan), any copolymers thereof, etc.); (6) bone tissue (e.g., bone powder and/or bone fragments); and/or the like. In some examples, these materials may form the body of an anchor element and/or a coating thereon. The anchor component may be formed of the same material(s) or different materials. Exemplary configurations with different materials may include a coupler formed of metal with leading anchor element formed of a titanium alloy and a compressor made of a polymer; a leading anchor element formed of cobalt-chrome, a coupler formed of metal and a trailing compressor element formed of a bioresorbable material, among others. The choice of materials is generally within the skill of a person having ordinary skill in the art of implantable medical devices.
The flexible bone fusion apparatus of the present teachings may be fabricated by any suitable process(es). For example, the anchor and coupler elements of the apparatus may be formed separately and then connected to one another.
Each anchor element may be formed by any suitable process(es). Exemplary processes include EDM, molding, machining, casting, forming, crimping, milling, and/or the like. Threads or other retention structure on the anchor elements may be formed at the same time as and/or after formation of other portions of the anchor elements.
The anchor elements and coupler may be connected by any suitable process that allows for the necessary movement after connection. Exemplary processes include snap-fitting the coupler into the lumen of the compressor element, to form a rotatable joint. The compressor lumen may have a mouth that is larger than the width of the coupler, so that the coupler, once it is forced past the mouth and engages the annular grooves within the coupler, remains trapped in the lumen. Other exemplary processes include disposing a coupler in a lumen having a lip, and then crimping or otherwise deforming the lip so that the coupler is retained in the lumen.
The flexible bone fusion apparatus may be installed by any suitable methods. Exemplary steps that may be performed are listed below. These steps may be performed in any suitable order, in any suitable combination, and any suitable number of times.
At least two bone members may be selected. The bone members may correspond to different bones or distinct fragments of the same bone, among others. The bone members may be adjacent one another naturally or may be moved so that they are adjacent one another. The bone members may have sustained or be associated with any suitable injury. For example, the bone members may result from an injury to bone (such as a fracture and/or an osteotomy, among others) or may be adjacent and/or connected to injured soft/connective tissue (e.g., ligament, tendon, and/or muscle, among others). In some examples, the bone members may be bones that articulate with one another through an anatomical joint. Any suitable anatomical joints may be selected, including the scapholunate joint, the acromioclavicular joint, DIP or PIP joints, etc. Any suitable adjacent bones may be selected, including bones of the hand (e.g. phalanges), wrist (e.g., carpal bones), arm, foot, ankle, leg, shoulder, etc.
A bone fusion apparatus may be selected. The bone fusion apparatus may have any combination of the features described elsewhere in the present disclosure including having a flexible joint. Furthermore, the bone fusion apparatus may have a size (e.g., length and width) selected according to the size of the bone members into which the bone fusion apparatus is to be placed (e.g., a narrower and/or shorter bone fusion apparatus for smaller bone members and a wider and/or longer bone fusion apparatus for larger bone members).
The flexible bone fusion apparatus may be placed into a pre-formed hole in the bone members. The hole may be formed, for example, by drilling through the proximal bone member and into the distal bone member (or vice versa). In some examples, the hole may be formed by drilling over a wire placed into the bone members, to define a guide path along which a drill and the flexible bone fusion apparatus travel. Accordingly, the drill and/or flexible bone fusion apparatus may be cannulated so that each can slide along the wire. Alternatively, the flexible bone fusion apparatus (and particularly a flexible bone screw) may be self-drilling so that it forms and/or widens its own hole as it advances into bone.
The flexible bone fusion apparatus may be left in place permanently or may be removed at a later time. Removal of the flexible bone fusion apparatus may take place at any suitable time. Exemplary times include at a predefined time or after a predefined amount of healing. In some examples, the flexible bone fusion apparatus (and/or an anchor element thereof) may be bioresorbable, so that the flexible bone fusion apparatus (and/or an anchor element thereof) is broken down by the body over time.
The following examples are illustrations of selected embodiments of the inventions discussed herein, and should not be applied so as to limit the appended claims in any manner.
Anchor portion 60 also features a plurality of facets 69a-d around the circumference of its anchor end 63 (
The end of the anchor portion 60 that engages the coupler 30 is the anchor attachment portion 21, seen best in
The second feature of anchor attachment portion 21 is the anchor annular groove 25, which like the coupler annular groove 28 is designed to accept and retain the locking wedge from the complementary attachment portion. Anchor annular groove 25 is defined by the anchor body 61 on one side, specifically the anchor groove inner wall 70, the anchor groove bottom 71, and the lower portion of the anchor axial face 24 on the side opposing the anchor body 61, the anchor groove se circular conical face 72. It will be noted that anchor groove semi-circular conical face 72 is not parallel to its opposing wall, but declines at approximately a 10 degree angle to provide a means for creating a friction face when the coupler and anchor are pulled apart. The 10 degree angled surface defines a partial cone in three dimensions, and the surface of the anchor groove semi-circular conical face 72 is therefore termed “conical,” although the apex of the cone, if present, would inhabit the empty space immediately above the axial face 24. It should be noted that other surfaces may also serve the function, including a spherical surface.
The third feature of anchor attachment portion 21 is the anchor axial face 24. The anchor axial face is a flat area that defines the rotational axis about which both attachment portions rotate, the center of the axis denoted by the dashed lines in
Complementary coupler attachment portion 22 has the same features with the same overall function and design features as the anchor attachment portion, but the features are reversed to complement or fit within the anchor attachment portion features. In this way they function together as a two-part interface to rotate about the single plane defined by the semi-circular conical faces located at the center of the attachment assembly 20. As previously mentioned, the anchor locking wedge 23 fits within the coupler annular groove 28 because the groove is machined to have a similar shape for receiving and holding the wedge, but in a manner that allows some amount of “slip” along the longitudinal axis of the flexible bone fusion device.
Coupler attachment portion 22 has three main features for facilitating rotating attachment to anchor attachment portion 21 of anchor 60. The first feature is the coupler locking wedge 26. Coupler locking wedge 26 is an irregularly-shaped element that fits into anchor annular groove 25 of anchor attachment portion 21. It has three main functions: to hold the top of the coupler attachment portion 22 within the anchor annular groove 25; when unlocked, to facilitate rotation in a single plane; and when installed to lock the angled configuration of the bone fusion apparatus in place. Coupler locking wedge 26 has a greater thickness at the edge 43 that engages with the opposing anchor groove bottom 71, as shown in
The second feature of coupler attachment portion 22 is the coupler annular groove 28, which like the anchor annular groove 25 is designed to accept and retain the locking wedge from the complementary attachment portion. Coupler annular groove 28 is defined by the coupler body 37 on one side, specifically the coupler groove inner wall 40, the coupler groove bottom 41, and the lower portion of the coupler axial face 27 on the side opposing the coupler body 37, the coupler groove semi-circular conical face 42. It will be noted that coupler groove semi-circular conical face 42 is not parallel to its opposing wall, but inclines at approximately a 10 degree angle to provide a means for creating a friction face when the coupler and anchor are pulled apart. The 10 degree angled surface defines a partial cone in three dimensions, and the surface of the coupler groove semi-circular conical face 42 is therefore termed “conical,” although the apex of the cone, if present, would inhabit the empty space immediately above the axial face 27. It should be noted that other surfaces may also serve the function, including a spherical surface.
The third feature of coupler attachment portion 22 is the coupler axial face 27. Coupler axial face 27 is a flat area that defines the rotational axis about which both attachment portions rotate, the center of the axis denoted by the dashed lines in
With reference to
Now with reference to
Coupler portion 30 also features a plurality of facets 39a-d around the circumference of its first end 31 (
With reference to
Compressor portion 10 also has a compressor lumen 13 having compressor lumen ridges 16 running lengthwise (or longitudinally) that engage the compressor grooves 118 on Compressor Tool 110.
Compressor portion 10 also features a plurality of facets 19a-d around the circumference of the end of compressor portion 10 that attaches to coupler portion 30 (
For a person having ordinary skill in the art, the detailed implementation of a snap-fit interface is well within his or her skill level. In this embodiment compressor portion 10 has one or more slots 15 cut into and through the body to allow for some radial expansion of the body as the coupler is being press-fit into it. Compressor portion 10 has internal compressor annular grooves 14, 17 cut into the lumen surface to accommodate the coupler annular ridges 35, 36. When the coupler second end (facing the compressor) is pressed into the internal diameter of the compressor, the compressor body will expand slightly and then as the ridges reach the grooves the ridges will snap down into the grooves and stop there. The fit of the grooves and ridges is such that axial rotation is allowed, that is, the diameter at the base of the grooves is close to the external diameter of the ridges. In a preferred embodiment this diameter is about 2.5 mm. In this embodiment, the function of the snap-fit interface in the assembled bone fusion apparatus is to allow free rotation of the compressor portion about the coupler portion. In this embodiment the coupler will be fixed and the compressor will rotate axially to adjust the amount of distance between the two bones or bane fragments. The free rotation at the coupler-compressor interface facilitates compression by insertion of the compressor tool into the compressor lumen, then rotating the compressor portion 10 counterclockwise until the bones contact each other.
After the anchor and compressor portions have been driven into position in the medial and proximal phalanges, compression of the bones may be desired. To compress the bones a separate tool called a “Compressor Tool” is used. Compressor tool 110 is best seen in
Generally, a “driving pattern” is a pattern of grooves, splines, blades or similar machined surfaces that mate with a complementary surface. An example is a TORX® drive, which is a machined shaft having a series of longitudinal grooves that engage a TORX screw or other fitting having a six-sided star-shaped pattern that is designed to accept a TORX driver and nothing else. Other drive patterns include a spline, double hexagonal, hexagonal, tri-wing, triple square, etc. These matching patterns allow compressor driving shaft 112 to fit securely within the lumens of compressor handle portion 111 and compressor portion 10. Compressor tool 110, in its coupled configuration, can then be used to rotate the compressor, thereby facilitating compression of the bones to be fused.
Compressor driver shaft 112 includes a shaft 114 with a loading shaft 116 at each end (
A fully assembled flexed bone fusion apparatus 5 is seen in
A further embodiment of the inventive concept described herein is a method of fusing the proximal and medial phalanges of either a toe or a finger. With reference to the figures, this is accomplished using an embodiment of the inventive apparatus comprising an anchor portion 60, a coupler portion 30, and a compressor portion 10, which together comprise a PIP Fusion Screw 5. First, the correct size Fusion Screw is selected using the x-ray template and pre-op x-rays. Screws sized for either the hand or the foot can be used. A 2 cm dorsal incision over the proximal interphalangeal joint (PIP) joint is then created. The surgeon will then release the collateral ligaments off the head of the proximal phalanx and surgically remove the PIP joint by removing all cartilage from both proximal and medial bones.
The joint can then be trimmed in one of two ways. The first method involves trimming the opposing bone faces flat with both faces having a slight angle relative to the centerline of the bones being connected (0° to 10°) to allow for proper alignment. Alternatively, the surgeon can form ball-and-socket shapes on the opposing faces of the middle and proximal phalanges to allow for alignment adjustments during the surgical procedure. Matched reamer tools can be used to accomplish the resurfacing necessary to accomplish this alternative method.
The surgeon will then center the designated diameter K-wire in the middle of the exposed face of the medial phalanx and drill all the way through the distal interphalangeal joint, continuing through and out of the end of the distal phalanx. Approximately 1-cm of the K-wire should be left exposed from the proximal end of the medial phalanx. The surgeon must then detach the drill and re-attach it at the other end of the K-wire that is protruding out the end of the distal phalanx.
After re-aligning the joint in a straightened orientation, the surgeon will drill the K-wire in the opposite direction so that it inserts approximately 1-cm into the proximal phalanx. The correct positioning of the K-wire can be verified via intraoperative fluoroscopy. The finger or toe should be straight and the K-wire should be centered in both planes. Next, the joint is pulled apart enough to remove the 1-cm portion of the K-wire from the proximal phalanx. The other portions of the K-wire are left in place in the medial and distal phalanges, extending through and out the end of the distal phalanx.
The anchor 60 is then installed into the proximal phalanx. First, it must be loaded into the delivery driver tool 100 so that cutting tip 62 extends away from the tool, as shown in
After the anchor is installed, the compressor assembly (compressor 10, coupler 30, and compressor driver shaft 112) is installed into the medial phalanx. First, the assembly must be loaded into the delivery driver 100 with the coupler-compressor loaded first and then the compressor driver shaft. Next, the surgeon aligns the detent 119 at the end of the compressor driver shaft with the tip of the K-wire emerging from the proximal end of the medial phalanx. The surgeon must then press the K-wire towards the end of the distal phalanx with the compressor driver shaft. When the compressor tip engages the medial phalanx, the delivery driver is rotated clockwise, thereby advancing the compressor into the bone until the coupler is located in the correct position relative to the end of the bone. The compressor driver shaft should be left in position, extending through the distal and medial phalanges.
Next, the anchor attachment portion 21 on anchor 60 and the coupler attachment portion 22 on coupler 30 can be hooked together, thereby linking the proximal and medial phalanges. To lock the joint in the desired angular orientation, the surgeon must pull the proximal and medial phalanges apart slightly. If it is necessary to reset the joint angle, the medial and proximal phalanges can be pushed together, thereby unlocking the joint. The phalanges can then be re-aligned for the correct degree of flex. The joint is then re-locked in the desired position by again pulling the proximal and medial phalanges apart. These steps may be repeated until the desired angle is achieved.
Once the device is installed at the correct angle, the proximal and medial phalanges can be compressed to facilitate bone fusion. The surgeon should install the compressor driver handle 111 onto the compressor driver shaft 112 emerging from the distal phalanx, thereby assembling the coupled configuration of compressor driver 110. Then, while holding the distal and medial phalanges, the compressor driver is turned counter-clockwise to draw the proximal and medial phalanges together. The turning of the compressor driver should stop when the resistance increases as the proximal and medial phalanges are compressed together. Intraoperative fluoroscopy can again be used to verify correct positioning of the PIP Fusion Screw 5 and that the bones are in the desired state of compression. Finally, the surgeon should remove the compressor driver shaft and handle, suture the ligament, and close the incisions. An illustration of a Fusion Screw installed in a PIP joint according to this embodiment is shown in
A third embodiment of the inventive concept described herein is an alternate method of fusing the proximal and medial phalanges of either a toe or a finger in which the coupler portion 30 is installed attached first to the anchor portion, rather than to the compressor portion 10 as in Example 2. With reference to the figures, this method also is accomplished using an embodiment of the inventive apparatus comprising an anchor portion 60, a coupler portion 30, and a compressor portion 10, which together comprise a PIP fusion screw or device 5. First, the correct size fusion screw is selected using the x-ray template and pre-op x-rays. Screws sized for either the hand or the foot can be used. A 2 cm dorsal incision over the proximal interphalangeal joint (PIP) joint is then created. The surgeon will then release the collateral ligaments off the head of the proximal phalanx and surgically remove the PIP joint by removing all cartilage from both proximal and medial bones.
The joint can then be trimmed in one of two ways. The first method involves trimming the opposing bone faces flat with both faces having a slight angle relative to the centerline of the bones being connected (0° to 10°) to allow for proper alignment. Alternatively, the surgeon can form ball-and-socket shapes on the opposing faces of the middle and proximal phalanges to allow for alignment adjustments during the surgical procedure. Matched reamer tools can be used to accomplish the resurfacing necessary to accomplish this alternative method.
The surgeon will then center the designated diameter K-wire in the middle of the exposed face of the medial phalanx and drill all the way through the distal interphalangeal joint, continuing through and out of the end of the distal phalanx. Approximately 1 cm of the K-wire should be left exposed from the proximal end of the medial phalanx. The surgeon must then detach the drill and re-attach it at the other end of the K-wire that is protruding out the end of the distal phalanx.
After re-aligning the joint in a straightened orientation, the surgeon will drill the K-wire in the opposite direction so that it inserts approximately 1 cm into the proximal phalanx. The correct positioning of the K-wire can be verified via intraoperative fluoroscopy. The finger or toe should be straight and the K-wire should be centered in both planes. Next, the joint is pulled apart enough to remove the 1 cm portion of the K-wire from the proximal phalanx. The other portions of the K-wire are left in place in the medial and distal phalanges, extending through and out the end of the distal phalanx.
Next, the anchor assembly (anchor 60 and coupler 30) is installed into the proximal phalanx. First, the assembly must be loaded into the delivery driver tool 100 with the anchor extending out of the delivery driver tool, as shown in
After the anchor assembly is installed, the compressor assembly (compressor 10 and compressor driver shaft 112) is installed into the medial phalanx. First, it must be loaded into the delivery driver 100 with the compressor driver shaft extending away from the delivery driver tool, as is shown in
Next, the coupler 30 can be snapped into the compressor assembly, thereby linking the proximal and medial phalanges. To lock the joint in the desired angular orientation, the surgeon must pull the proximal and medial phalanges apart slightly. If it is necessary to reset the joint angle, the medial and proximal phalanges can be pushed together, thereby unlocking the joint. The phalanges can then be re-aligned for the correct degree of flex. The joint is then re-locked in the desired position by again pulling the proximal and medial phalanges apart. These steps may be repeated until the desired angle is achieved.
Once the device is installed at the correct angle, the proximal and medial phalanges can be compressed to facilitate bone fusion. The surgeon should install the compressor driver handle 111 onto the compressor driver shaft 112 emerging from the distal phalanx, thereby assembling the coupled configuration of compressor driver 110. Then, while holding the distal and medial phalanges, the compressor driver is turned counter-clockwise to draw the proximal and medial phalanges together. The turning of the compressor driver should stop when the resistance increases as the proximal and medial phalanges are compressed together. Intraoperative fluoroscopy can again be used to verify correct positioning of the PIP fusion screw 5 and that the bones are in the desired state of compression. Finally, the surgeon should remove the compressor driver shaft and handle, suture the ligament, and close the incisions.
An alternate installation method to those of Examples 2-3 is presented herein. In this embodiment there is no compression driver tool as depicted in
Alternate compressor driver tool 130 is depicted in
A fifth embodiment of the invention, shown in
Coupling end 68 is roughly cylindrical in shape and has an external diameter that is sized to fit within compressor portion 10. At least one annular ridge 64 is disposed upon the surface of coupling end 68 for engaging with mating compressor annular groove 14 in compressor 10 (
Coupling end 68 also includes an alignment groove 67 that runs longitudinally along its length. Thus, alignment groove 67 runs perpendicular to the annular ridges 64 and 66, thereby disrupting their continuity so that the annular ridges 64 and 66 do not span the entire circumference of coupling end 68 (
Delivery tool 200, shown in
Installation of this linear two-part apparatus is similar to the installation procedures described in Examples 2-4. However, because this embodiment does not include a coupler portion, no assembly takes place prior to installation. Rather, the anchor portion and compressor portion are each individually installed, without an accompanying coupler portion, in the manner described in Examples 2 and 3. Delivery tool 200 is used to drive anchor portion 60 into the proximal phalanx, while delivery tool 100 is used to drive compressor portion 10 into the medial phalanx. After both portions are installed, they are coupled by snap-fitting coupling end 68 into compressor lumen 13. Compression of the proximal and medial phalanges can then occur as described in Examples 2-4, using either compressor tool 110 or compressor tool 130, depending on whether compression occurs through the distal phalanx or the medial phalanx.
A sixth embodiment of the invention, shown in
Because of the bent conformation of the anchor portion 60, a slightly modified delivery tool 300, shown in
The installation procedure of this embodiment is identical to that of Example 5. However, delivery tool 300 must be used in place of delivery tool 200 to drive anchor portion 60 into the proximal phalanx. All other steps of the installation process remain the same.
The embodiments of the invention also comprise kits that include one or more of the bone fusion apparatus of varying sizes and diameters to fit the application, delivery and compression tools, K-wires, drills and drill bits and a case for holding the tools and parts. Components of the kit may be sterile and/or sterilizable (e.g., autoclavable). In some examples, components of the kit, such as bone fusion apparatus and/or wires, may be intended for single use. In some examples, components of the kit, such as drills and/or drivers, may be intended or suitable for repeated use. One embodiment of a kit comprises a flexible bone fusion apparatus comprising:
It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications that come within the scope and spirit of the claims appended hereto. All patents and references cited herein are explicitly incorporated by reference in their entirety.
This application is a divisional of U.S. patent application Ser. No. 14/249,193, filed Apr. 9, 2014, which in turn is a divisional of U.S. patent application Ser. No. 13/230,668, filed Sep. 12, 2011, now abandoned, which application in turn claims priority to U.S. Provisional Patent Application Ser. No. 61/381,732, filed Sep. 10, 2010, all incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61381732 | Sep 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14249193 | Apr 2014 | US |
| Child | 16027125 | US | |
| Parent | 13230668 | Sep 2011 | US |
| Child | 14249193 | US |
