US20060058796A1 - Compression brace - Google Patents

Compression brace Download PDF

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Publication number
US20060058796A1
US20060058796A1 US10/940,396 US94039604A US2006058796A1 US 20060058796 A1 US20060058796 A1 US 20060058796A1 US 94039604 A US94039604 A US 94039604A US 2006058796 A1 US2006058796 A1 US 2006058796A1
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United States
Prior art keywords
fastener
compression
bone
fasteners
brace
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Abandoned
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US10/940,396
Inventor
Vernon Hartdegen
Kevin Wong
Robert Fencl
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Wright Medical Technology Inc
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Wright Medical Technology Inc
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Priority to US10/940,396 priority Critical patent/US20060058796A1/en
Assigned to WRIGHT MEDICAL TECHNOLOGY INC. reassignment WRIGHT MEDICAL TECHNOLOGY INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FENCI, ROBERT M., HARTDEGEN, VERNON R., WONG, KEVIN
Priority to US11/060,965 priority patent/US8221478B2/en
Publication of US20060058796A1 publication Critical patent/US20060058796A1/en
Application status is Abandoned legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66Alignment, compression or distraction mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1728Guides or aligning means for drills, mills, pins or wires for holes for bone plates or plate screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7059Cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8004Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for extending or compressing the bone or bones
    • A61B17/8014Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for extending or compressing the bone or bones the extension or compression force being caused by interaction of the plate hole and the screws
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8085Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips for craniofacial surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1775Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the foot or ankle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1782Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hand or wrist
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Threaded wires, pins or screws; Nuts therefor
    • A61B17/8605Heads, i.e. proximal ends projecting from bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8872Instruments for putting said fixation devices against or away from the bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875Screwdrivers, spanners or wrenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B2017/681Alignment, compression, or distraction mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter

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
  • Not applicable
  • 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. No. 5,449,359 (Groiso); U.S. Pat. No. 5,660,188 (Groiso); U.S. Pat. No. 5,853,414 (Groiso); U.S. Pat. No. 5,947,999 (Groiso); and U.S. Pat. No. 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, SOB 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, SOB 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 SOA, SOB 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 fasterner 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 m etatarsophalangeal 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 (14)

1-15. (canceled)
16. A surgical device for pressing and retaining adjacent bones against one another, such as to reduce a fracture, comprising:
a compression brace,
said compression brace having at least two fastener retaining portions, each said fastener retaining portion having a fastener hole therethrough for receiving a fastener, said fastener hole having an internal thread,
a pair of bridge members positioned between said fastener retaining portions, said bridge members spaced apart from one another to thereby form a compression opening between said fastener retaining portions, and
at least two fasteners, each said fastener having
a lengthwise shaft sized to pass through said fastener hole and a head portion sized and configured to retain said fastener in said fastener hole,
an upper thread on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole to thereby maintain said fastener in a substantially fixed relation to said fastener retaining portion.
17. The device of claim 16, wherein said substantially fixed relation between said fastener and said fastener retaining portion is substantially perpendicular.
18. The device of claim 16, wherein said upper thread comprises double lead threads, said double-lead threads providing selective locking of said fastener in said fastener hole
19. The device of claim 16, wherein at least one of said fasteners is a screw, said shaft of said screw having a lower thread positioned to engage bone.
20. The device of claim 19, wherein said lower thread is self-drilling in bone.
21. The device of claim 20, further comprising a cutting means along said tip of said screw for facilitating initial engagement of bone by said lower thread.
22. The device of claim 16, wherein at least one of said fasteners is a pin.
23. The device of claim 16, further comprising each said fastener retaining portion having a counterbore formed in an upper surface thereof, said counterbore substantially in axial alignment with said fastener hole, said counterbore sized and configured to provide countersinking of said upper retainer portion of said fastener in said fastener retaining portion.
24. The device of claim 16, wherein each said bridge member is substantially V-shaped.
25. The device of claim 16, wherein said compression brace includes a plurality of fastener retaining portions and a plurality of compression openings.
26. A method of compressing and retaining first and second adjacent bones together, such as to reduce a fracture, comprising:
providing a compression brace, said compression brace having at least two fastener retaining portions, each said fastener retaining portion having a fastener hole therethrough for receiving a fastener, said fastener hole having an internal thread, a pair of bridge members positioned between said fastener retaining portions, said bridge members spaced apart from one another to thereby form a compression opening between said fastener retaining portions;
providing at least two fasteners, each said fastener having a lengthwise shaft sized to pass fastener hole, and an upper thread on said shaft adjacent said head of said fastener for engaging said internal thread in said fastener hole to thereby maintain said fastener in a substantially fixed relation to said fastener retaining portion;
placing the compression brace on the bones such that one of said fastener holes is on the first bone and one of said fastener holes is on the second bone;
securing the compression brace on the first bone by threading one of said fasteners into one of said fastener holes and into the first bone;
securing the compression brace on the second bone by threading one of said fasteners into a second one of said fastener holes and into the second bone; and
spreading the bridge members of the compression brace apart to thereby draw said fasteners and said bones toward one another.
27. The method of claim 1, further comprising, prior to said step of securing the compression bracket on the bones, forming a hole in each of the bones for receiving the fasteners.
28. The method of claim 1, wherein said bridge members are spread until said bones contact one another.
US10/940,396 2004-09-14 2004-09-14 Compression brace Abandoned US20060058796A1 (en)

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US10/940,396 US20060058796A1 (en) 2004-09-14 2004-09-14 Compression brace
US11/060,965 US8221478B2 (en) 2004-09-14 2005-02-18 Snap-off surgical screw

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US10/940,396 US20060058796A1 (en) 2004-09-14 2004-09-14 Compression brace
US11/060,965 US8221478B2 (en) 2004-09-14 2005-02-18 Snap-off surgical screw
PCT/US2005/032333 WO2006031692A2 (en) 2004-09-14 2005-09-09 Snap-off surgical screw
US12/582,210 US20100036430A1 (en) 2004-09-14 2009-10-20 Compression brace
US14/172,547 US20140316470A1 (en) 2004-09-14 2014-02-04 Compression brace
US14/329,429 US20150012004A1 (en) 2004-09-14 2014-07-11 Compression brace

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US11/060,965 Continuation-In-Part US8221478B2 (en) 2004-09-14 2005-02-18 Snap-off surgical screw
US12/582,210 Continuation US20100036430A1 (en) 2004-09-14 2009-10-20 Compression brace

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US11/060,965 Active 2030-01-19 US8221478B2 (en) 2004-09-14 2005-02-18 Snap-off surgical screw
US12/582,210 Abandoned US20100036430A1 (en) 2004-09-14 2009-10-20 Compression brace
US14/172,547 Abandoned US20140316470A1 (en) 2004-09-14 2014-02-04 Compression brace
US14/329,429 Abandoned US20150012004A1 (en) 2004-09-14 2014-07-11 Compression brace

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US12/582,210 Abandoned US20100036430A1 (en) 2004-09-14 2009-10-20 Compression brace
US14/172,547 Abandoned US20140316470A1 (en) 2004-09-14 2014-02-04 Compression brace
US14/329,429 Abandoned US20150012004A1 (en) 2004-09-14 2014-07-11 Compression brace

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US20060081553A1 (en) 2006-04-20
US8221478B2 (en) 2012-07-17

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