US20100036430A1

US20100036430A1 - Compression brace

Info

Publication number: US20100036430A1
Application number: US12/582,210
Authority: US
Inventors: Vernon R. Hartdegen; Kevin Wong; Robert M. Fencl
Original assignee: Wright Medical Technology Inc
Current assignee: Wright Medical Technology Inc
Priority date: 2004-09-14
Filing date: 2009-10-20
Publication date: 2010-02-11
Also published as: US20060081553A1; US20140316470A1; WO2006031692A3; WO2006031692A2; US20060058796A1; US8221478B2; US20150012004A1

Abstract

A surgical device for pressing and retaining adjacent bones against one another comprising a compression brace and separate fasteners. The compression brace has at least two fastener retaining portions. Each fastener retaining portion has a fastener hole therethrough for receiving a fastener, such as a screw or pin. A pair of bridge members are positioned between the fastener retaining portions, and are spaced apart from one another to form a compression opening. The compression bracket can include a plurality of fastener retaining portions and a plurality of compression openings. In some embodiments, the fasteners are maintained in a substantially fixed relation with the fastener retaining portion. The brace is installed on adjacent bones such that a fastener engages each bone. The compression opening is spread apart to draw the fasteners toward one another, and thereby compress the adjacent bones together.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 10/940,396, which was filed on Sep. 14, 2004, the entirety of which is herein incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO A MICROFICHE APPENDIX

Not applicable.

FIELD OF THE INVENTION

The present invention relates generally to orthopedic surgery, and more particularly to devices and methods for reduction of fractures and osteotomies by drawing bones together.

BACKGROUND OF THE INVENTION

U.S. Pat. No. 2,597,342 (Lang) discloses the use of a compressible fastener for joining boards together. The Lang fastener includes a central loop portion and claw members that extend from diametrically opposed sides of the central loop. The loop is preferably a parallelogram. Each claw member has two claws. Each claw has downwardly turned ends with inwardly turned portions which are configured to penetrate and engage boards. In operation, the claw members are set astraddle adjacent board members. The central loop is then expanded outward to draw the opposing arms toward one another and thereby fasten the adjacent boards together.
The earliest use of a compression opening in a surgical application appears to be U.S. Pat. No. 4,887,601 (Richards). Richards discloses an adjustable surgical staple having a slotted spine and downwardly depending legs on opposing ends of the spine. The legs are bent toward or away from the spine. However, a straight leg embodiment is discussed with reference to FIGS. 7 and 8. The Richards staple appears to have been intended for use in ophthalmic surgery.
The use of a compressible bone staples for fracture reduction is disclosed in U.S. Pat. Nos. 5,449,359 (Groiso); 5,660,188 (Groiso); 5,853,414 (Groiso); 5,947,999 (Groiso); and 5,993,476 (Groiso) (collectively, “the Groiso patents”). However, the Groiso patents, which are incorporated herein by reference, disclose the use of staples having downwardly depending legs for engaging adjacent bones. The Groiso compression bone staples suffer from several drawbacks. Staples having opposing spaced-apart bridges can be difficult and therefore expensive to manufacture. See e.g. U.S. Pat. No. 5,947,999 (Col. 1, lines 48-52). Positioning holes in the bones such that they align with the legs of the staple can be challenging, and typically requires specialized instrumentation. Additionally, staple legs tend to splay outward during use in vivo, which may reduce the compressive force of the staple. Staples can pull out of the bones. The configuration of staples also reduces intra-operative choices. In order to accommodate varying inter-axis and leg length requirements, it is necessary to provide a wide array of staple sizes, which requires extra inventory. A staple conventionally has legs of the same length and diameter/cross-section, which may make the staple unsuitable for situations in which it is desirable to have a longer or larger leg on one side of the staple. Thus, even with a large inventory of staple sizes, intra-operative choices may be limited.
One of the Groiso patents, U.S. Pat. No. 5,947,999, discloses a compressible bone staple that has a pair of wing members extending from opposing ends of the staple, each wing member having apertures therein for receiving a screw for fastening the clip member to a bio-organic tissue member. However, the '999 patent does not teach elimination of the downwardly depending leg portions of the staple. In fact, Groiso teaches away from elimination of the leg portions by noting “the aim of attaining a desired spacing between bone fragments could be obtained with connecting elements such as plates and screws, but these are much bulkier, require major surgical procedures for the placing thereof and the possibility of trauma is increased.” U.S. Pat. No. 5,947,999 (Col. 2, lines 55-59). Additionally, the '999 patent is direct toward connecting soft tissues (tendons and ligaments) to bone.
U.S. Pat. No. 4,444,181 (Wevers et al.) discloses a bone clip for repair of bones in vivo including a body having a slot in a central portion thereof and a pair of downwardly depending legs on either end of the body. After the clip is inserted in opposing bones, opposing bridges are compressed toward one another (rather than expanded) to shorten the clip and thereby draw the bones together.
The use of bone screws and bone plates to reduce fractures is well known in the art. However, as far as the applicant is aware, no attempt has been made to provide a brace and screw combination that has the ability to pull bone fragments together in the efficient and highly effective manner described herein. There is thus a need for a surgical device having the following characteristics and advantages over the prior art.

OBJECTS AND SUMMARY OF THE INVENTION

It is an object of the invention to provide an improved means of compressing adjacent bones together in surgical applications.
It is an object of the invention to provide a substitute for surgical compression staples that has superior anchorage in bone.
It is an object of the invention to increase intra-operative choices by allowing a surgeon to select desired lengths and diameters of fasteners.
It is an object of the invention to reduce inventory by allowing a surgeon to mix and match between braces and fasteners.
The foregoing objects and advantages are achieved by providing a surgical device for pressing and retaining adjacent bones against one another comprising a compression brace and separate fasteners. The compression brace has at least two fastener retaining portions. Each fastener retaining portion has a fastener hole therethrough for receiving a fastener. A pair of bridge members are positioned between the fastener retaining portions, and are spaced apart from one another to thereby form a compression opening between the fastener retaining portions. Each bridge member is preferably substantially V-shaped. The fasteners are sized and configured to pass through the fastener hole and retain the compression bracket on bones. The fasteners preferably have a lengthwise shaft sized to pass through the fastener hole and an upper retainer portion sized and configured to retain the fastener in the fastener hole. In one embodiment, the fasteners are screws having a lower thread positioned to engage bone. In an alternative embodiment, the fasteners are pins. The compression bracket can include a plurality of fastener retaining portions and a plurality of compression openings.
The device is preferably provided with a means for selectively locking the fasteners in the fastener holes to maintain the fasteners in a substantially fixed relation with the fastener retaining portion. Alternatively, the fastener hole of the brace member may be substantially smooth. The shaft of at least one of the fasteners can be sized to provide play between the shaft and the fastener hole, such that the fastener can be selectively angled into bone during use of the device.
The foregoing and other objects, features, aspects and advantages of the invention will become more apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of one preferred embodiment of a compression brace of the invention, showing the brace in an uncompressed configuration.

FIG. 2 is a top view of the compression brace of FIG. 1, showing the brace in a compressed configuration and featuring a pair of screws disposed in the brace.

FIG. 3 is a side cross-section of view taken along 3-3 of FIG. 1.

FIG. 4 is a side partial cross-section view illustrating use of the compression brace of the invention to reduce a fracture by drawing adjacent bones together, featuring the brace in an uncompressed configuration prior to reduction of the fracture.

FIG. 5 is a side partial cross-section view illustrating use of the compression brace of the invention to reduce a fracture by drawing adjacent bones together, featuring the brace in a compressed configuration.

FIG. 6 is a top view of a preferred embodiment of the compression brace of the invention, featuring an unthreaded fastener hole.

FIG. 7 is a side cross-section view taken along 7-7 of FIG. 6, and illustrating radial play of a screw within the unthreaded fastener hole.

FIGS. 8A-C show views of one preferred embodiment of the invention, featuring a pair of compression brackets joined end-to-end.

FIG. 9 provides views of one preferred embodiment of the invention, featuring a plurality of clip members radiating from a shared fastener retaining portion.

FIG. 10 provides views of one preferred embodiment of the invention, featuring a plurality of compression brackets joined end-to-end via shared fastener retaining portions, and including a branching compression bracket.

FIG. 11 is a side view of a preferred embodiment of a screw type fastener for use in the invention.

FIG. 12 is a side perspective view of a preferred embodiment of a pin-type fastener for use in the invention.

FIG. 13 provides views of one preferred embodiment of the invention, featuring a pair of compression brackets joined end-to-end via a shared fastener retaining portion.

FIG. 14 provides views of one preferred embodiment of the invention.

FIG. 15 provides views of one preferred embodiment of the invention.

FIG. 16 provides views of one preferred embodiment of the invention.

FIG. 17 provides views of one preferred embodiment of the invention.

FIG. 18 provides views of one preferred embodiment of the invention.

FIG. 19 provides views of one preferred embodiment of the invention.

FIG. 20 is a perspective view of one embodiment of a drill guide instrument for use in installing the compression brackets of the invention.

FIG. 21 provides perspective views of drivers for use with the drill guide instrument of FIG. 20.

FIG. 22 provides views of a snap-off screw for use with the compression brace of the invention.

PREFERRED EMBODIMENTS OF THE INVENTION

In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.
As shown in FIGS. 4 and 5, the invention is a surgical device for pressing and retaining adjacent bones 301, 302 against one another, such as to reduce a fracture. As shown in the uncompressed configuration of FIG. 4, the invention includes, generally, a compression brace 1 and fasteners 100 for securing the brace on bones 301, 302. As indicated in the compressed configuration of FIG. 5, compression of the brace 1 presses the adjacent bone fragments 301, 302 together.
As shown in FIG. 1, in a preferred embodiment the compression brace 1 has at least two fastener retaining portions 10. Each fastener retaining portion 10 has a fastener hole or bore 20 therethrough for receiving a fastener 100. In a preferred embodiment shown in FIG. 3, a thread 22 is provided in the fastener hole 20. As indicated in the side view of FIG. 3, the brace 1 can be considered to have a tissue or osteo side 2, which sits against the bones during use, and an opposing side or outer surface 3. As shown in FIG. 3, the fastener retaining portion 10 preferably has a counterbore 30 formed in the outer surface 3. The counterbore 30 is preferably substantially in axial alignment with the fastener hole 20. The counterbore 30 is preferably spherical. The counterbore 30 is sized and configured to provide countersinking of an upper retainer portion 150 of a fastener 100 in the fastener retaining portion 10 of the compression brace 1.
A pair of bridge members 50A, 50B are positioned between the fastener retaining portions 10. The bridge members 50A, 50B preferably extend directly from the fastener retaining portions 10, but may be spaced from one or both of the fastener retaining portions, such as by a shared extension portion disposed between the bridge members 50A, 50B and fastener retainer portions 10. The bridge members 50A, 50B are spaced apart from one another to form a compression opening 70 between the fastener retaining portions 10. The bridge members 50A, 50B and the compression opening 70 are used to compress the fastener retaining portions 10 and fasteners 100 toward one another, in a manner described in further detail below.
In the preferred embodiment shown in FIG. 1, the bridge members 50A, 50B are substantially V-shaped. The V-shape is preferably formed by generally linear portions 51, 52, which normally join one another at an obtuse angle when the brace 10 is in an uncompressed configuration. When opposing expansion forces are applied to the bridges 50A, 50B substantially along lines of force F in FIG. 1, central portions of the bridge members 50A, 50B expand outward, thus drawing or compressing the fastener retaining portions 10 toward one another. FIG. 2 demonstrates the configuration of the compression brace of FIG. 1 after it has been compressed a selected amount. Note that in FIG. 2, the compression brace 1 has contracted generally along its lengthwise axis, while the opposing bridge members 50A, 50B have expanded in directions generally transverse to the lengthwise axis. Alternatively, the bridge members 50A, 50B can be pinched toward one another. Pinching will tend to force the fastener retaining portions 10 apart, particularly when using a V-shaped opening, which can be useful for certain surgical applications, such as distractions. In this manner, the compression brace 1 can be used both for compression and distraction, as well as to provide for fine-tuning of bone gap sizes and compressive forces. Pinching can also be used to force the fastener retaining portions 10 toward one another, resulting in compression.
Bridge members 50A, 50B may alternatively have curved, arcuate, straight, or other deformable configurations, provided that bridges 50A, 50B are configured to form a deformable compression opening 70. In FIG. 6, the bridge members 50A, 50B are shortened and form a tighter angle along the compression opening 70. FIG. 6 also shows an embodiment in which a chamfer is formed along the upper edge of the compression brace 1.
As shown in FIG. 4, fasteners 100 are used to secure the bracket 1 to adjacent bones 301, 302. Each fastener 100 is sized and configured to pass through a fastener hole 20 and to retain the compression bracket 1 on bones 301, 302. Fasteners 100 of differing diameter can be used. For example, if angulation of the fastener 100 is desired, a smaller diameter may be used. The fasteners 100 may be locking or non-locking. In a preferred embodiment shown in FIG. 11, each fastener 100 has a lengthwise shaft 110 sized to pass through at least one of the fastener holes 20, and an upper retainer portion 150 sized and configured to retain the fastener 100 in the fastener hole 20. As shown in FIG. 11, the retainer portion 150 is preferably a circumferential head of the type used in conventional screws. The head 150 is preferably provided with a self-retaining drive mechanism, such as press-fit drive slots 155.
As shown in FIG. 11, the fastener 100 is preferably a screw 100, in which case the shaft 110 is provided with a lower thread 112 that is positioned to engage bone. The lower thread 112 is preferably self-tapping and self-drilling in bone. To facilitate tapping of the lower thread 112 into bone, a cutting means 115 is preferably provided on or adjacent the tip of the screw 100. Cutting means are well known to those of skill in the art of surgical screws.
As shown in FIG. 12, an alternative preferred fastener 100 is a pin 100. The pin 100 shown in FIG. 12 has an enlarged head or fastener retainer portion 150 configured to retain the pin 100 in the fastener retainer member 10. The shaft 110 of the pin 100 preferably has a substantially smooth outer surface.
In a preferred embodiment shown in FIG. 11, an upper thread 120 is provided on the shaft 110 adjacent the head of the fastener 100 for use in engaging the internal thread 22 in the fastener hole 20. In a preferred embodiment, the upper thread 120 of the fastener 100 and the internal thread 22 of the compression brace 1 serve to maintain the fastener 100 in a substantially fixed relation to the fastener retaining portion 10. For example, in FIG. 5, an upper thread 120 has maintained the fasteners 100 in a substantially perpendicular relation to the fastener retainer portion 10. In the preferred embodiment of FIG. 5, the fasteners 100 have maintained a substantially fixed relation even after the compression bracket 1 has been compressed to draw the bones 301, 302 together. A substantially fixed relationship can also be obtained by providing a snug-fit screw head appropriately sized to the fastener hole 20 and counterbore 30. In the prior art uni-body compression staples disclosed in the Groiso patents, the pins of the staples tend to splay outward significantly during use in vivo, decreasing the compressive strength of the staples.
The invention may be provided with a means 130 for selectively locking the fastener 100 in the fastener hole 20. In the preferred embodiment shown in FIG. 11, the locking means 130 is provided by forming the upper thread 120 from double- lead threads 132, 133. The double- lead threads 132, 133 provide selective locking of the fastener 100 in the fastener hole 20 via locking interaction with the single internal thread 22 of the fastener hole 20. One advantage of a double-lead type of locking means 130 is that the threads can be configured such that the compression bracket 1 can be reused, for example if it becomes necessary to remove and replace or reposition the original fastener 100. Other locking means include mismatched threads.
As shown in FIG. 7, the surgical device may be configured such that there is play between the fastener 100 and the fastener retaining portion 10. In the preferred embodiment shown in FIG. 7, the fastener hole 20 of the brace member is substantially smooth, i.e. unthreaded. Additionally, the shaft 110 of the fastener 100 is sized to provide play between the shaft 100 and the fastener hole 20. As indicated in FIG. 7, this configuration allows the fastener 100 to be selectively angled into bone during use of the device.
Snap-off screws, such as the type shown in FIG. 22, can be used as fasteners 100. The snap-off surgical screw shown in FIG. 22B is similar to the screws described above in that it has a head 150, an upper threaded part 120 providing a locking thread 130 distal to the head, and a bore thread 112 distal to the locking thread 130. Additionally, a shaft extension 160 extends above the poly-axial head for use in rotating and driving the screw. The shaft extension 160 is axially aligned with the screw 100. A distal end of the shaft extension 160 is fixedly connected to the head 150 of the screw by a narrow shaft 161. After the screw 100 is inserted, the shaft 160 is broken off of the screw 100 at the point of the narrow shaft 161.
FIGS. 14-17 provide views of various embodiments of compression brackets 1 of the invention. The bracket shown in FIGS. 14A-14C has an elongated compression opening 70. FIGS. 15A-15C show a compression bracket 1 having a spaced apart bridge members 50A, 50B, such that the opposing ends of the bridge members 50A, 50B are not directly adjacent one another. FIGS. 16A-16C show a compression bracket 1 having spaced apart bridge members 50A, 50B. Additionally, the spaced apart bridge members 50A, 50B of FIG. 16 are straight, and thus lack the V-shaped configuration of other embodiments. The configuration of FIG. 16 is particularly adapted for situations in which it may be desirable to obtain compression by bending the bridge members 50A, 50B toward one another rather than by spreading the bridge members apart, although the bridges 50A, 50B can also be spread. The bracket shown in FIGS. 17A-17C has a straight and generally narrow compression opening 70, but is provided with diametrically opposed distal curved portions for use in engaging the bridge members 50A, 50B during spreading of the compression opening 70.
FIGS. 18A-18C show yet another embodiment in which the opposing bridge, and hence the compression opening 70, are eliminated in favor of a single bridge 50. The single bridge 50 can be bent in order to draw the opposing fastener retaining portions 10 together. Otherwise, the embodiment shown in FIGS. 18A-18C can be provided with the various threaded and unthreaded variations described above.
FIGS. 19A-19D show an embodiment that combines the features of prior art surgical staples with the advantages provided by the compression bracket 1 of the present invention. As shown in FIG. 19A, the combined staple-compression bracket includes opposing bridge members 50A, 50B and a fastener retaining portion 10 having the configuration and characteristics described above. However, the opposing end of the device is provided with a downwardly depending leg 200. The downwardly depending leg 200 is preferably provided with means for securing the leg 200 in bone, such as the proximal 201 and distal 202 teeth or serrations shown in FIG. 19C.
As shown in FIGS. 8-10 and 13, the compression bracket 1 can include a plurality of fastener retaining portions 10 and a plurality of compression openings 70. In the embodiment shown in FIGS. 8A-8C, a pair of compression brackets are joined end-to-end in a unitary or unibody compression bracket structure. FIGS. 13A-C show an end-to-end configuration in which bridge members 50A, 50B are joined by a shared fastener retaining portion 10. In FIGS. 9A-9C, a plurality of bridge members 50A, 50B radiate from a shared fastener retaining portion 10. In FIGS. 10A-10C, a plurality of compression brackets 1 are joined end-to-end via shared fastener retaining portions 10. FIG. 10 also includes a compression bracket that branches off from the main chain via a shared fastener retaining portion 10. Multi-part compression brackets can also be configured to include adjacent compression openings that are not separated by a fastener retaining member 20. Multi-compression brackets such as those shown in FIGS. 8-10 are particularly suited for fixation or distraction of multi-part fractures, such as when a bone fractures into more than two fragments. The multi-compression bracket embodiments shown in FIGS. 8-10 are merely exemplary preferred embodiments of the invention, and are intended to provide those with skill in the art with the building blocks necessary to configure a wide variety of multi-compression bracket configurations, all of which would fall within the scope of the invention.
One of the advantages of the invention over the prior art is that it enables a surgeon to intra-operatively select various combinations of brace and fastener sizes and configurations to accommodate the operative condition of a particular surgical site, thus providing greater options while decreasing staple inventory. To further enhance options, compression braces 1 can be provided with a combination of threaded and unthreaded holes. Such a configuration could be used, for example, in situations where it is desirable to provide a perpendicularly locked fastener on one end of the brace 1, while providing selective angulation of the fastener 100 on the opposing end of the brace. The same effect can be obtained by selecting a fastener 100 sized to permit angulation through a relatively larger threaded hole 20, such that the threads of the hole 20 do not substantially impinge on the selected degree of angulation. Similarly, a combination of locking and non-locking threads can be used.
The compression brace 1 is used primarily for fixation of arthrodeses and osteotomies. The compression brace 1 can also be used in place of conventional plates, such as cuboid plates, hind or mid-foot plates, or calcaneal plates.
In operation, the compression brace 1 is used as follows. After preparation of the surgical site, the compression brace 1 is placed on adjacent bones 301, 302 such that one of the fastener holes is on the first bone or bone fragment 301 and one of the fastener holes 302 is on the second bone or bone fragment (see FIG. 4). The first and second bones 301, 302 may of course be fragments or segments of the same bone, i.e. after fracture. The compression brace 1 is secured on the first bone 301 by inserting a fastener 100 through one of the fastener holes 20 and into the first bone 301. The compression brace 1 is secured to the second bone 302 by inserting a fastener 100 through one of the fastener holes 20 and into the second bone. The bridge members 50A, 50B of the compression brace 1 are then spread apart to draw the fasteners 100 and the bones 301, 302 toward one another. During spreading of the bridge members 50A, 50B during compression, sufficient force can be applied to press adjacent bones 301, 302 against one another to substantially eliminate a gap 300 between the bones 301, 302. Alternatively, sufficient force can be applied to move the bones 301, 302 toward one another a selected distance, but without removing the gap 300. With fractures having more than two bone fragments, more than one compression brace 1 can be used to fix the fracture. Alternatively, a multi-compression bracket such as the embodiments shown in FIGS. 8-10 can be used to fix the various bone fragments. In one embodiment of the method, holes are drilled into the bones 301, 302 through the fastener holes 20, and the fasteners 100 are then installed in the drilled holes. Pre-drilling is unnecessary if self-drilling fasteners 100 are used.
The compression bracket 1 can also be used as a distraction plate, such as for opening osteotomies (e.g. HTO or spine distraction). By applying a force to bridge members 50A, 50B, a space can be created or widened, thus forcing the fasteners 100 apart. The device 1 can be used to open a space to allow insertion of a spacer, and then used to close the space in order to sandwich the spacer between adjacent bones.
The compression bracket 1 can be installed with or without specialized instrumentation. FIG. 20 shows a preferred drill guide instrument 300 for use in installing the compression braces 1. The drill guide 300 includes a handle or mounting arm 310 having an extension portion 312. A stationary guide base 318 is fixedly mounted on an upper end of the extension portion 312. As shown in FIG. 20, an adjustable guide base 328 is slidably and adjustably engaged to the stationary guide base 318 via an adjustment member 320 having a lengthwise opening 321 therethrough. A locking means 312 is provided for selectively locking the adjustable guide base 328 relative to the stationary guide base 318. In the embodiment shown in FIG. 20, the locking means is a ring 330 threaded on the extension portion 312.
A first drill guide 301 is fixedly mounted on the stationary guide base 318, while a second drill guide 302 is fixedly mounted on the adjustable guide base 328. The drill guides 301, 302 are preferably removable from the drill guide instrument in order to accommodate selected sizes and configurations of fasteners 100 and compression braces 1. A distal end of the drill guide 301, 302 is provided with a counter bore having a side slot 304 therethrough for accommodating a compression brace 1, in the manner shown in FIG. 20.
As indicated in FIG. 20, each drill guide 301, 302 has a lengthwise cylindrical sleeve (not shown) passing therethrough. As shown in FIG. 20, the sleeves are sized to receive and provide rotational guidance to driver components such as drill bit 380 (preferred embodiment shown in FIG. 21A) or a screwdriver 390 (preferred embodiment shown in FIG. 21B). As shown in FIGS. 21A and 21B, the driver components 380, 390 have a cylindrical shaft portion 384 sized to permit guided rotation within the drill guides 301, 302. A stop 386 is provided on the shaft 384. The stop 386 is sized and positioned to abut against the drill guide 301, 302, the guide base 318, 328 or another selected portion of the drill guide instrument 300 to prevent over drilling. The drive components 380, 390 are provided with a conventional 388 mount on an upper end for selective engagement with a drive means, in a manner known to those of skill in the art. As shown in FIG. 21A, the drill bit driver component 380 is provided with a drill bit 381. As shown in FIG. 21B, the screw driver component 390 is provided with a screw driver head 391 configured to match the fasteners 100. Various sizes and types of drill bits 381 and screwdrivers 391 can be used with the drill guide instrument 300, depending on intra-operative conditions. A tamping driver (not shown) can be provided for inserting pins 100 with the drill guide instrumentation 300.
As indicated in FIG. 20, the drill guide instrument 300 can be adjusted to the size of a selected compression brace 1 simply by sliding the second drill guide 302 relative to the first drill guide 301 until a suitable position is reached, and then locking the second drill guide 302 in place via the locking means 330. The drill guide instrument 300 aligns the axes of the driver components 380, 390 with those of the fastener holes 20, which enables precise drilling or threading of fastener screws 100.
Spreading of the bridge members 50A, 50B is preferably accomplished using a spreader, such as the type shown in FIG. 10 of U.S. Pat. No. 5,660,188 (Groiso). If crimping of the bridge members 50A, 50B is desired, pliers can be used.
The device and method can be used to join, fix and maintain bones in various procedures, including: LisFranc arthrodesis; mono or bi-cortical osteotomies in the forefoot; first metatarsophalangeal arthrodesis; Akin osteotomy; midfoot and hindfoot arthrodeses or osteotomies; fixation of osteotomies for hallux valgus treatment (Scarf and Chevron); and arthrodeses of the metatarsocuneiform joint to reposition and stabilize the metatarsus primus varus; carpal bone fusion; wrist fusion; elbow fracture; and metacarpal fractures.
The compression brace 1 and fasteners 100 are preferably made of suitable biocompatible materials having sufficient mechanical strength and elasticity for the desired applications of the invention 1. Suitable materials include medical grade titanium alloys, medical grade stainless steel, and cobalt chrome. A memory metal, such as nitinol, can be incorporated into the invention. Suitable non-metallic biocompatible materials can also be used. Further, the brace 1 or fasteners 100 can be made of a suitable bio-absorbable material, such that the components are eventually absorbed by the body after healing of the bone parts.
Unless the context indicates otherwise, the term “bone” as used herein includes whole bones as well as bone fragments (i.e. the two or more fragments of a particular bone that remain after the bone has been fractured, either completely or incompletely).
Although the present invention has been described in terms of specific embodiments, it is anticipated that alterations and modifications thereof will no doubt become apparent to those skilled in the art. It is therefore intended that the following claims be interpreted as covering all alterations and modifications that fall within the true spirit and scope of the invention.

Claims

1. A surgical device, in combination, comprising:

a compression brace having an outer side and a substantially planar osteo side, the osteo side disposed opposite the outer side, the compression brace including

first and second fastener retainers, each of the first and second fastener retainers defining a threaded opening, and

first and second bridge members disposed between the first and second fastener retainers and defining a first compression opening; and

first and second fasteners sized and configured to be received within the threaded openings defined by the first and second fastener retainers, each of the first and second fasteners including an elongate shaft extending from the head, the elongate shafts including a first threaded portion disposed adjacent to the head, the first threaded portion including threads sized and configured to engage the threaded openings defined by the first and second fastener retainers,

wherein the first and second bridge members are formed from a memory metal and are configured to be deformed such that a width of the first compression opening is adjusted to provide compression or distraction to adjacent bone segments when the compression brace is secured to the adjacent bone segments.

2. The surgical device of claim 1, wherein the first and second bridge members are spaced apart from one another in a substantially unbiased relationship.

3. The surgical device of claim 1, wherein the first and second fasteners include a second threaded portion along the elongate shaft, the second threaded portion sized and configured to engage bone.

4. The surgical device of claim 4, wherein the first and second fasteners include a cutting means disposed at end opposite the head.

5. The surgical device claim 1, wherein the first threaded portion of the first and second fasteners includes double lead threads.

6. The surgical device of claim 1, wherein the compression brace includes:

a third fastener retainer, and

third and fourth bridge members disposed between the second and third fastener retainers and defining a second compression opening, the third and fourth bridge members formed from a memory metal.

7. The surgical device of claim 6, wherein the compression brace includes:

a fourth fastener retainer, and

fifth and sixth bridge members disposed between the second and fourth fastener retainers, the fifth and sixth bridge members formed from a memory metal and defining a third compression opening.

8. A method of installing a surgical device, comprising:

inserting a first elongate shaft of a first fastener into a first threaded opening defined by a first fastener retainer of a compression brace, the compression brace including

a second fastener retainer defining a second threaded opening defined by the second threaded opening, and

first and second bridge members disposed between the first and second fastener retainers and defining a first compression opening having a width, the first and second bridge members formed from a memory metal;

engaging a first threaded portion of the first elongate shaft with the threads of the first threaded opening to secure the first fastener to the compression brace and to a first bone segment; inserting a second elongate shaft of a second fastener into the second threaded opening of the compression brace;

engaging a second threaded portion of the second elongate shaft with the threads of the second threaded opening to secure the second fastener to the compression brace and to a second bone segment; and

deforming at least one of the first and second bridge members to adjust the width of the width of the first compression opening thereby providing one of distraction or compression to the first and second bone segments.

9. The method of claim 8, wherein the first and second bridge members are configured to maintain a width of the first compression opening after being deformed.

10. The method of claim 8, wherein the first fastener includes a third threaded portion along the first elongate shaft configured to engage bone.

11. The method of claim 10, wherein the second fastener includes a fourth threaded portion along the second elongate shaft configured to engage bone.

12. The method of claim 8, wherein the first and second threaded portions include double lead threads.

13. The method of claim 8, wherein the compression brace includes an outer side and a substantially planar osteo side disposed opposite the outer side.

14. A compression brace, comprising:

a first fastener retaining portion defining a first threaded opening and including a first countersink that is axially aligned with an axis defined by the first threaded opening, the first countersink inwardly extending from an outer side of the compression brace;

a second fastener retaining portion defining a second threaded opening and including a second countersink that is axially aligned with an axis defined by the second threaded opening, the second countersink inwardly extending from the outer side of the compression brace;

a first bridge member extending from the first fastener retaining portion to the second fastener retaining portion; and

a second bridge member extending from the first fastener retaining portion to the second fastener retaining portion,

wherein the first and second bridge members are formed from a memory metal and define a first compression opening therebetween, the first and second bridge members configured to be deformed to adjust a width of the first compression opening thereby providing one of a compression or distraction force to adjacent bone segments when the compression brace is secured to the adjacent bone segments.

15. The compression brace of claim 14, wherein the first threaded opening is configured to receive a first fastener including a first head and a first elongate shaft extending from the first head, the first elongate shaft having a first threaded portion adjacent to the first head.

16. The compression brace of claim 15, wherein the second threaded opening is configured to receive a second fastener including a second head and a second elongate shaft extending from the second head, the second elongate shaft having a second threaded portion adjacent to the second head.

17. The compression brace of claim 16, wherein the first and second threaded portions are double lead threads configured to respectively lock the first and second fasteners in the first and second threaded openings.

18. The compression brace of claim 14, wherein the compression brace includes a substantially planar osteo side disposed opposite the outer side.

19. The compression brace of claim 14, wherein the first and second bridge members are substantially parallel each other and include diametrically opposed distal curved portions.

20. The compression brace of claim 14, further comprising:

a third fastener retaining portion defining a third threaded opening and including a third countersink that is axially aligned with an axis defined by the third threaded opening, the third countersink inwardly extending from the outer side of the compression brace, the third fastener opening disposed adjacent to the first fastener retaining portion;

a fourth fastener retaining portion defining a fourth threaded opening and including a fourth countersink that is axially aligned with an axis defined by the fourth threaded opening, the fourth countersink inwardly extending from the outer side of the compression brace;

a third bridge member extending from the third fastener retaining portion to the fourth fastener retaining portion; and

a fourth bridge member extending from the third fastener retaining portion to the fourth fastener retaining portion,

wherein the third and fourth bridge members are formed from a memory metal and define a second compression opening therebetween, the third and fourth bridge members configured to be deformed to adjust a width of the second compression opening thereby providing one of a compression or distraction force to adjacent bone segments when the compression brace is secured to the adjacent bone segments.