Patent Description:
Trauma to the mid-hand and mid-foot can have life-changing effects for the victim as a result of loss of function, disfiguration, and even the lengthy and onerous treatment protocols. It's hard and sometimes impossible to do without the use of a foot or hand, and in particular, when one is living "hand to mouth".

Current methods of treatment include internal fixation with surgery, like plating systems and wire fixation or in the case of non-displaced fractures, casting the hand or foot without surgical intervention. These treatments involve a substantial period, i.e., several weeks or months, in which the injured hand or foot is immobilized. However, serious problems with adhesions, loss of muscle, proprioception and nerve health, can result from dis-use for these periods of time. Moreover, beyond the side effects of the treatment protocol, there are problems with compliance and with the issues of daily living that result from not being able to use a hand or foot for these prolonged periods of time.

While it is possible for hand and foot accidents to occur during various activities, including traffic accidents, firearm mis-fire, and extreme sport activities, there is a greater correlation of the risk for such traumatic events in manual and low wage jobs. Thus, the incidence and the effects of such accidents are skewed to jobs on the lower end of the pay-scale and may often involve workers who are already at economic risk. Thus, victims of hand or foot trauma will often either resort to non-compliance involving the early use of the injured limb, or in some instances will suffer the loss of income, including the loss of a job altogether, which sets off a spiraling decline in the ability to "make ends meet", expanding the risk from the injury to the loss of house and home and family stability.

Finally, it should be noted that the hand is paramount to every aspect of our humanity and is instrumental in dictating and defining our relationship to our world. Injury to the hand hinders that relationship and our perception of our role in that world, especially in cases where the hand is disfigured, or appears to be disabled. Our hands are constantly in view to ourselves and to the world, and debilitating scars or irregularities such as scars, and even the Frankenstein-like outlines of surgical hardware on the mid-hand, are visible and painful reminders of a traumatic event and its aftermath.

The prior art orthopedic implants for use in small bones in the arms and legs have a set of criteria that differs from those of the long bones and large joints. These bones, (generally in the elbow and below and the knee and below), tend to be smaller in diameter and present a differing ratio of cortical to cancellous bone, as well as the issues of covering soft tissue and a relatively large nexus of tendons, ligaments and nerves, to complicate surgical techniques. The present invention is intended to answer these issues, and to provide a solution to surgical fixation of broken or fractured small bones through a threaded nail intended for intramedullary fixation and most importantly, allowing a swift return to daily living, and reduced disability, pain, and rehabilitation.

One typical small bone implant location is the hand or foot, and in particular in the metacarpals and metatarsals. The structure of the hand is composed of the scaphoid and other carpal bones which meet with the radius and the ulna at the wrist joint, the metacarpals, and phalanges. The back of the hand includes the metacarpals, and a metacarpal connects each finger and thumb to the hand, while the fingers and thumb are formed of bones called phalanges. The connection of the phalanges to the metacarpals is called a "knuckle" joint or metacarpophalangeal joint (MCP joint), and acts like a hinge when the fingers or thumb are bent. In each finger, there are three phalanges that are separated by two joints called the interphalangeal joints (IP joints). The proximal IP joint (PIP joint) is the one closest to the MCP joint. The other joint closest to the end of the finger is the distal IP joint (DIP joint). The thumb just has one IP joint. The joints are covered on the ends with articular cartilage. The foot has an analogous structure, with the talus interfacing between the tibia and the fibula on the leg, and the calcaneus or the foot, and the mid-foot being comprised of the tarsals, including the cuneiforms, (i.e., the cuboid and the navicular bones,) the metatarsals, and the phalanges.

Damage to these bones of the extremities may occur as a result of a sprain or fracture or trauma and typically following reduction to re-align a damaged bone, it should be stabilized in position to allow it to heal in that position.

in the past, a surgical procedure to stabilize these broken bones has involved drilling a pilot hole and insertion of a k-wire or smooth nail along the length of the bone to hold it in position while the bone heals. An opening is first formed in the metacarpal bone, wherein the opening extends through the fracture and the nail is positioned by wedging it in the opening through the soft cancellous intermediate bone so that the nail provides stability for the parts of the bone on either side of the fracture. After a certain period, a second surgery is required to remove the nail from the bone. Problems with this procedure are that, because it is not anchored in the bone and in fact, mostly interfaces with the spongy central bone pulp, it can migrate through the metacarpal bone and into surrounding tissue. Sometimes this can result in damage to soft tissue, such as a severed or damaged tendon or cartilage, and/or cause pain. Another problem with the nail is that, because it can migrate, a second surgery is required to remove it. Additionally, the proximal end of pins and nails can cause tendon irritation, tendon rupture or skin irritation and infection.

One theoretical solution to this problem is to insert a screw into the bone however, the torque required to place a screw into the length of a metacarpal bone (which is a relatively thin, delicate but brittle bone) is high. Such a procedure would be lengthy, and there would be a possibility of bone damage, or damage to the driving head of the screw, which could prevent complete insertion into the opening formed in the bone. Current screws are not designed specifically for intramedullary placement. For instance, the current screws are frequently not long enough, nor do they account for the narrowed waist of the metacarpal or metatarsal bones.

Document <CIT> discloses an exemplary intramedullary metatarsal implant for fixation of a fracture.

Thus, the present invention is intended for fixation of intra-articular and extra-articular fractures and non-unions of metatarsals and metacarpals, and is preferably intended for intramedullary fixation of metacarpal and phalangeal fractures to provide surgeons with a reliable solution through a simple approach. The robust length offering, (more than <NUM> centimeters, and preferably more than <NUM> centimeters, or <NUM> centimeters +/- <NUM> or <NUM> centimeters, or even up to <NUM> centimeters), with large length to diameter ratio (more than <NUM>:<NUM>, and preferably more than <NUM>:<NUM>), and with a differential diameter (having a leading length at a smaller diameter of <NUM>-<NUM>, and a trailing length towards the nail head, of from <NUM>-<NUM> smaller, with good examples of <NUM>/<NUM> or <NUM>/<NUM>), accurately fits native metacarpal and phalangeal locations to create a strong, stable fixation and precise reduction. Moreover, the invention is intended to fill the intramedullary canal along substantially all its length (i.e., more that <NUM>%, or preferably more than <NUM>%, and preferably more than <NUM>%, or <NUM>% and up to <NUM>% or <NUM>% by length). The design includes a leading, meaning away from the nail end, section having a smaller outer diameter of the root and also of the thread crest at that section, but a relatively constant internal cannulation where the leading section is from <NUM>-<NUM>% of the length. The larger diameter section reinforces the area next to the torque receiving end of the nail so that the greater material allows transmission of the torque through the device, and the cutting flutes in the transition section between the dual diameters helps to keep the smaller leading portion from collapsing on itself. Thus, the device is designed to allow both insertion and removal by screwing or unscrewing the implant into the intermedullary canal.

in addition, the invention is unique as it is designed to capture internal cortical bone so that not only does the nail extend a substantial distance of the length of the shaft (at least <NUM>% including penetration past the isthmus), it also is used so that is achieves "radial" or "circumferential" fixation within the canal, and preferably, achieves <NUM>°internal circumferential cortical fixation. This is novel for the metacarpal application since the metacarpals (and metatarsals) include a narrowed waist area, the "isthmus" of the metacarpal (and metatarsals). Past screws and intermedullary implants are not designed to engage with sufficient length or to grab the internal walls of the canal circumferentially over substantial distance of the length, but the current design includes a stepped diameter with a leading cutting tip and an intermediate cutting feature that allows the invention to ream the canal to size as it is advanced through the canal. Thus, the canal is prepped for circumferential cortical fixation, which is unique to the present invention and refers to the use of an implant that includes a surface that is fixed to the internal cortical wall or of the intermedullary shaft, in particular of the metacarpal of the metatarsal. The nail is intended to avoid applying a compressive force along the length of the nail, and can be used in instances in which there is a void in the bone or missing bone fragments and nail stabilizes the remaining bone fragments with a gap to restore the length of the metacarpal. The nail is dual diameter with both leading-diameter and trailing-diameter sections substantially cylindrical and, importantly, not tapered or conical to permit the device to maintain contact with the hole in the canal during removal and to ease removal by unscrewing the nail.

The present invention can be used in a procedure that lets the patient return to work in a short period of time, from two weeks to the next day, including jobs ranging from manual labor, care-giver, professional musician, artist, and professional athlete. This return to functional living, and the decrease in down-time, and rehabilitation and risk to daily living is a huge societal saving.

The present invention solves the problems associated with repairing a metacarpal or metatarsal fracture or dislocation by providing a device that is a unique combination of a nail and a screw, which can be inserted into the bone without damaging the bone because it is sized and shaped to achieve circumferential intramedullary cortical fixation and to support the bone from the inside, (even when there's a bone gap of from <NUM> up to <NUM>, <NUM>, or even <NUM> along the length of a damaged metacarpal), to fit the narrowed portion of these bones by providing at least one stepped diameter and a fluted transition between the diameters, by providing a headless design with a uniform lead(s) which avoids compression and which can be seated below the surface of the bone to avoid the irritation that can result from a proud portion; by providing for a cannulated surgical technique with an intramedullary implant designed to minimize soft tissue, cartilage and vascular damage upon insertion; and to facilitate early, active mobilization post-operative protocols for accelerated healing and earlier return to work.

Further, as the device achieves radial internal fixation, the device is secured within the bone, which eliminates migration and eliminates the need for a second operation to remove the device. Thus, the device provides a cannulated cylindrical core having an outer exterior surface along its length, (from <NUM> to <NUM>, or even as long as lengths to <NUM> or <NUM>) that defines an inner diameter (minor diameter) relative to the lateral edge of a threaded portion which defines an outer diameter (major diameter). The design includes one or more stepped portion which allow for an increase in the trailing portion of at least the outer diameter or the inner diameter, and more preferably of both the outer diameter and the inner diameter. The transition area also includes longitudinal cutting flutes (<NUM>-<NUM> of <NUM> to <NUM> length) to account for this increase at a length of the nail (i.e., from <NUM>% to <NUM>%, of the distance of the length from the trailing end) which allows a clearance of the narrowed or "waisted" portion of the bone. The cannulation is generally a constant diameter (for ease of manufacture) through the length of the nail, but could include a dual diameter which might include an over grind at the larger diameter or trailing end of the nail which includes the torque driving feature, such as an internal or external hexagon or hexalobe configuration.

The device includes a leading portion that has <NUM>-<NUM> cutting teeth on the beveled leading tip, and along the long side, also includes additional longitudinal flutes, which, as are the other flutes, intended to provide for reaming away of the cancellous intermedullary material and for scoring of the inner surface of the intramedullary channel as well as a place for additional cancellous material to reside during surgery.

The thread defined between the outer diameter and the inner diameter can suitably include a right handed single start thread with a pitch of from <NUM> to <NUM>, and preferably at least <NUM>+/-<NUM>, or a dual lead thread of the same lead value and a pitch value half of the lead value with a secondary thread having a lower height, i.e., from <NUM>% to <NUM>% or <NUM>% +/- <NUM>% of the height of the primary thread. The leading and following flanks of the threads together form an angle of <NUM>° to <NUM>°, and preferably <NUM>° ± <NUM>°, and are connected by a thread crest of length <NUM> to <NUM> which is separated from the root diameter by a thread depth of <NUM> to <NUM>.

At its first end, or trailing end, the device includes a driving recess capable of being driven by a suitable driver into the opening, such as a hexalobe or a T10 drive recess, to generate significant torque to bite into the cortical bone and avoid harm to the lower material narrower leading end of the nail.

<FIG> shows an exemplary embodiment <NUM> of the threaded intramedullary nail of the present invention. The nail <NUM> may be formed of any suitable biocompatible material, such as surgical grade stainless steel, titanium, alloys of nickel and chromium, nitinol, PEEK, hydroxyapatite, bio-glass or other bio compatible materials or combinations of these materials. The nail <NUM> has a first end, or proximal end, <NUM>, a second end, or distal end, <NUM>, a shaft <NUM> with an outer surface <NUM>, and a center portion <NUM> between first end <NUM> and second end <NUM>. A cutting end <NUM> with a bevel and two, three or four teeth 19a is provided at the trailing end <NUM> (which is distal relative to the torque driving recess but is implanted in the proximal portion of the metacarpal) and a driving surface <NUM> in a drive recess <NUM> is formed in the top of first end <NUM>.

The cutting point <NUM> helps to cut through any bone left behind when the bone is drilled to receive device <NUM>, and further include <NUM>-<NUM> equally radially spaced longitudinal cutting flutes <NUM> which extend lengthwise in the exterior surface and through the threads of the nail <NUM>. The driving surface <NUM> in this embodiment has a hexalobe drive configuration, although any suitable driving configuration may be used. Other driving configurations that may be used include slotted, Pozidriv, Robertson, tri-wing, Torq-Set, Spanner Head, Triple Square and hex head.

Extending length wise in outer surface <NUM>, preferably along the longitudinal axis of shaft <NUM>, are grooves or cutting flutes <NUM>. As used herein, "extending length wise" means that each groove <NUM> is elongated and extends along the shaft with one end of the groove nearer the first end <NUM> and the opposite end of the groove nearer the second end <NUM>, but grooves <NUM> may be formed at an angle and not necessarily formed along the longitudinal axis shaft <NUM>, although that is preferred. Grooves <NUM> preferably have edges that assist in boring the device <NUM> into and anchoring device <NUM> in the opening in a bone. Grooves <NUM> also may capture some debris left behind from the bone drilling process to create the opening created when device <NUM> is positioned into the opening.

The shaft <NUM> of the nail <NUM> of the present invention includes at least two sections of differing diameters, for example, a proximal section that extends for a length of from about <NUM>% to <NUM>% of the length of the device, and which is located at from <NUM>% to <NUM>%, and preferably at <NUM>-<NUM>% of the distance of the length from the distal end of the device <NUM>. Further, the device provides a cannulated cylindrical core or shaft <NUM> having an outer exterior surface <NUM> along its length, (which is provided in <NUM> increments from <NUM> to <NUM>) that defines an inner diameter relative to the lateral edge of a threaded portion which defines an outer diameter. The design includes one or more stepped portion which allow for a <NUM>-<NUM> increase in the proximal portion of at least the outer diameter or the inner diameter, and more preferably of both the outer diameter and the inner diameter. The transition area also includes longitudinal cutting flutes (<NUM>-<NUM> of <NUM> to <NUM> length) to account for this increase at a length of the nail (i.e., from <NUM>% to <NUM>%, of the distance of the length from the proximal end) which allows a clearance of the narrowed or "waisted" portion of the bone,.

The device includes a thread <NUM> which is defined between the outer diameter and the inner diameter and can suitably include a right-handed single start thread with a pitch of from <NUM> to <NUM>, and preferably at least <NUM>+/-<NUM> with a similar lead value. Alternatively, as is shown in <FIG>, the device may include a double lead thread <NUM> having a first thread <NUM> and a second thread <NUM> of the same lead value with the second thread <NUM> having a height that is approximately <NUM>% of the height of the first thread <NUM>.

The leading and following flanks of the threads together form an angle of <NUM>° to <NUM>°, and preferably <NUM> ± <NUM>°, and are connected by a thread crest of length. <NUM> which is separated from the root diameter by a thread depth of <NUM> to <NUM>.

<FIG> illustrates a nail <NUM> in accordance with the present invention in position in a fourth metacarpal and securing a reduced fracture.

In <FIG>, in a first step of a surgical technique in accordance with the invention, the size of the metacarpal <NUM> at issue is determined in order to size the implant.

In <FIG>, it is illustrated that the fracture in the bone is aligned and then a guide wire <NUM> is inserted in the intramedullary canal in retrograde.

<FIG> illustrates the optimal position <NUM> for the insertion of the guide wire.

In <FIG> a cannulated drill <NUM>, uses the guide wire as a guide to drill an opening into the metacarpal bone which extends through the fracture and provides enough space on each side of the fracture to properly position device <NUM>.

In <FIG>, the device <NUM> is driven into the opening in the metacarpal bone by means of the drive recess. The outer diameter of the threads <NUM>, is slightly larger than the inner diameter of the opening in the bone. This provides bone material for threads <NUM> to thread into and provides a tight fit for device <NUM>.

Claim 1:
An intramedullary implant (<NUM>) comprising:
a shaft (<NUM>) having a headless first end (<NUM>) with a torque driving recess (<NUM>) which is spaced apart along a longitudinal axis from a second end (<NUM>) including a cutting surface (<NUM>), and
a first threaded section extending from the first end (<NUM>) to an intermediate transition and having an inner diameter and an outer diameter and either the inner diameter or the outer diameter being a first constant value from the first end (<NUM>) to the intermediate transition, and
a second threaded section extending between the intermediate transition and the second end (<NUM>) and having an inner diameter and an outer diameter and either the inner diameter or the outer diameter being a second constant value from the second end (<NUM>) to the intermediate transition, wherein the first constant value is larger than the second constant value,
wherein the thread (<NUM>) of the first threaded section has the same pitch as the thread of the second threaded section;
wherein the thread (<NUM>) of the intermediate transition is contiguous with the thread (<NUM>) of the first threaded section and the thread (<NUM>) of the second threaded section;
wherein the intermediate transition includes a plurality of radially spaced longitudinal cutting flutes (<NUM>) located at from <NUM>% to <NUM>% of the distance of the length from the first end (<NUM>);
wherein the intermediate transition includes a taper; wherein the plurality of radially spaced longitudinal cutting flutes (<NUM>) intersects the taper; and
wherein the implant is configured to be enclosed within an intramedullary canal of a metatarsal or metacarpal for fixation of a fracture.