US20040127908A1 - Cranial clamp with torque-limiting feature - Google Patents
Cranial clamp with torque-limiting feature Download PDFInfo
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- US20040127908A1 US20040127908A1 US10/735,449 US73544903A US2004127908A1 US 20040127908 A1 US20040127908 A1 US 20040127908A1 US 73544903 A US73544903 A US 73544903A US 2004127908 A1 US2004127908 A1 US 2004127908A1
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- Prior art keywords
- cap
- post
- base
- clamp assembly
- bone plate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical 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
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/688—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for reattaching pieces of the skull
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical 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
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8875—Screwdrivers, spanners or wrenches
- A61B17/8877—Screwdrivers, spanners or wrenches characterised by the cross-section of the driver bit
- A61B17/8883—Screwdrivers, spanners or wrenches characterised by the cross-section of the driver bit the driver bit acting on the periphery of the screw head
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/031—Automatic limiting or abutting means, e.g. for safety torque limiting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, 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
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
- Y10S606/908—Bioabsorbable material
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Surgical Instruments (AREA)
Abstract
Description
- This case is a continuation of U.S. patent application Ser. No. 10/255,146, filed Sep. 25, 2002, which claims priority on U.S. provisional patent application Serial No. 60/324,658, filed Sep. 25, 2001.
- This invention relates to a fastener for quickly and securely fastening a bone plate to surrounding bone. In one embodiment, the fastener contains a torque-limiting feature to prevent over tightening when in the fastening position. In another embodiment, the invention relates to an instrument for applying the fastener to a bone plate and surrounding bone.
- When performing surgery on the brain, it is often necessary to perform a craniotomy to provide access to portions of the brain. A craniotomy is a surgical procedure in which a portion of the cranium is removed to permit access to the brain. To perform the craniotomy, one or more holes are initially drilled through the skull. These holes, known as “burr holes,” may be located, for example, at the corners of a triangular region of bone that is to be temporarily removed. A saw, i.e., a craniotome, is then used to cut the skull along the line of separation connecting the adjoining burr holes. The resulting bone cover or bone plug is subsequently lifted from the underlying dura matter to expose the brain. The bone cover may either be completely removed from the cranium, or folded back in a flap along an uncut edge of the flap.
- After completion of the procedure on the brain, the bone cover must be re-attached to the skull. Several devices have been developed that are used to facilitate securing the bone cover to the skull. These devices suffer from the disadvantage that they are cumbersome or inefficient to apply to the bone flap and surrounding bone. Further, prior designs are relatively rigid, thus decreasing conformance to the curvature of the skull. Moreover, prior designs often required significant instrumentation to apply and/or adjust the device used to secure the bone cover to the skull. Finally, prior designs may require removal of the fastening device after sufficient healing along the line of separation.
- The Cranial Clamp And Method For Fixating A Bone Plate according to the invention generally includes a cap and base adjustably joined by a post for threadably bringing the opposing cap and base closer together, thereby tightening them against the internal and external surfaces of the bone plate and surrounding cranium. The base and cap securely fix the bone plate to the surrounding bone. In one embodiment, at least one of the base, cap and post include resorbable material.
- The clamp according to the invention may further include an applier interacting with the post to position the cap and base to securely fix the bone plate to the surrounding bone. Once appropriately secured, the applier is removed from the post while leaving the cap and base interconnected. In one embodiment, the applier includes a keyed bore and the post includes a key for engaging the keyed bore of the applier.
- The clamp according to the invention may also include a torque-limiting feature on the post. The torque-limiting feature prevents stripping of the threaded interconnection between the post and cap or overtightening of the cap relative the base. In one embodiment, the torque-limiting feature is disposed at a junction between an elongated body portion and a keyed portion of the post.
- The method for fixating a bone plate in a bony defect according to the invention allows a bone plate to be fixed in apposition against a transverse face of surrounding bone along the border of junction between the bone plate and surrounding bone. A base connected to an elongated externally threaded post projecting from the base, and a cap with an internally threaded collar for mating and threaded engagement with the threaded post connected to the base, is provided. In one embodiment, at least one of the base, cap, and post include resorbable material. The base and cap are placed on opposing internal and external surfaces of the bone plate, with a portion of each of the base and cap overlapping the border of junction. The post is rotated into the collar to bring the base and cap to a fastening position having the base and cap in tight engagement against the opposing internal and external surfaces of the bone plate. At least one of the base, cap, and post include resorbable material, which is resorbed by the body.
- The method according to the invention may further include providing an applier, wherein the applier rotates the post through inter-engagement of the applier with the post. The method according to the invention may also include removing a distal portion of the post projecting from the cap and leaving a proximal portion of the post projecting from the cap. Moreover, the proximal portion of the post projecting from the cap may be deformed to secure the base and cap in the fastening position.
- Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
- The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
- FIG. 1 is a partial perspective view of a clamp and applier according to the invention securing a bone plate to surrounding cranium;
- FIG. 2 is a partial sectional view of a clamp and applier cut along line2-2 of FIG. 1;
- FIG. 3 is a partially sectioned side view of an assembled clamp and applier according to the invention;
- FIG. 4 is a top view of a base of a clamp according to the invention;
- FIG. 5 is a sectional view cut along line5-5 of FIG. 4;
- FIG. 6 is a side view of a post of the clamp according to the invention;
- FIG. 7 is an end view of the post of FIG. 6;
- FIG. 8 is a top view of a cap of the clamp according to the invention;
- FIG. 9 is a side view of the cap of FIG. 8;
- FIG. 10 is a bottom view of the cap of FIG. 8;
- FIG. 11 is a sectional view cut along line11-11 of FIG. 8;
- FIG. 12 is a sectional view of an applier according to the invention cut along line12-12 of FIG. 3;
- FIG. 13 is an end view of the applier of FIG. 12;
- FIG. 14 is a top view of an alternative embodiment of the clamp according to the invention;
- FIG. 15 is an exploded perspective view with an alternative embodiment of the clamp according to the invention;
- FIG. 16 is a sectional side view of the assembled clamp of FIG. 15; and
- FIG. 17 is a sectional side view of an assembled clamp according to another embodiment of the invention.
- The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. While the present invention is shown securing a bone plate to a surrounding cranium, the fastener of the present invention may be used in other surgical and non-surgical applications as well.
- The present invention includes fasteners for securing flat or curved plate structures to each other. The invention also includes a positioning and applying instrument that is particularly useful for positioning and applying the fasteners in a surgical wound and for securing the fasteners to each other.
- As shown in the drawings, the fastener according to the invention is a
clamp 10 for closing a craniotomy. A craniotomy is performed by incising pericranium and muscle with cutting diathermy in the line of an intended bone flap. An incision is not made interiorly where a pedicle of pericranium or temporalis muscle is often left uncut to allow some blood supply to the bone and overlying tissue to remain intact. Alternatively, the pericranium and muscle may be detached completely from the intended bone flap. - As illustrated in FIGS. 1 and 2, the craniotomy is performed by making a series of burr holes12 through the
cranium 28 about six or seven centimeters apart with a cranial perforator. Alternatively, a trephine can be used. The underlying dura matter is separated from the bone covering the osteotomy site (“the bone cover”) using a periosteal elevator.Osteotomies 14 between the burr holes 12 are then made using a craniotome that is passed between adjacent burr holes 12 and moved back and forth to make theosteotomies 14 from the internal to the external surfaces of thecranium 28. Alternatively, a Gigli flexible saw can be used to make theosteotomies 14. Abase 16 is not cut with the saw. A bone forceps (such as a deVilbis forceps) is used to ply a bone plate 18 until the bridge breaks at the base 16 when the bone plate 18 is elevated. - The bone plate18 is separated from the surrounding
cranium osteotomies 14. Eachburr hole 12 has a plate portion 12(a) and a complimentary cranial portion 12(b), which together form the completedburr hole 12. Trephines come in graduated sizes, for example, between 0.5 and 2 inches (13-51 millimeters) diameter for drilling burr holes 12 of sizes varying across this usual range. - The bone plate18 may be completely removed if osteotomies connect all of the burr holes 12. It is often preferred, however, to leave an intact edge of the craniotomy (such as base 16) to preserve the blood supplied to the bone. In either case, the bone plate 18 is typically referred to as the cranial cover.
- After the neurosurgical procedure is performed, the bone defect must be repaired by placing the bone plate18 back in the defect with opposing
internal surface 20 and external surface 22 substantially coplanar or aligned with theinternal surface 24 andexternal surface 26 of surroundingcranium 28. Atransverse face 30 of bone plate 18 must also be fixed in opposition with atransverse face 32 ofcranium 28 along a border of junction defined by theosteotomy 14 between bone plate 18 and surroundingcranium 28. - In an embodiment shown in FIG. 3, the
clamp 10 includes a first member orbase 100 selectively connected to a second member orcap 150 via apost 120. Thecap 150 andbase 120 are brought toward one another by an instrument orapplier 170. In one embodiment, thebase 100,post 120,cap 150 andapplier 170 are assembled prior to use in securing the bone plate 18. In another embodiment, thebase 100,post 120 andcap 150 are assembled prior to use in securing the bone plate 18. Yet another embodiment include an assembledbase 100 and post 120, and thecap 150 andapplier 170 are assembled after positioning thebase 100 and post 120 to secure the bone plate 18. - As shown in FIGS. 4 and 5, the
base 100 is formed by a generally solid disk having acentral aperture 102, an annularinner face 104 surrounding theaperture 102, and anouter face 108 except for acentral recess 106 disposed coaxial with theaperture 102. Theouter face 108 surrounds thecentral recess 106 and generally accommodates the annularinner face 104. Theinner face 104 andouter face 108 circumscribe acollar 110 projecting inwardly from theinner face 104 coaxially aboutcentral aperture 102. In this embodiment,aperture 102 extends throughbase 100 and is adapted to receive thepost 120, whereby thepost 120 is able to rotate relative thebase 100. In other embodiments,aperture 102 may only have an opening at the inner side ofcollar 110 and not extend through thebase 100. - As shown in FIGS. 6 and 7, the
post 120 includes ahead 122 at a first end and a key 124 at a second end. A substantially cylindrical,elongated body 126 extends between thehead 122 and key 124, and generally includes ribs orthreads 128 along its length.Threads 128 will be used in the following description, but ribs are within the scope of the invention. At the head Attorney Docket No. 5490-000259/COB end of thepost 120, thethreads 128 taper or run out from a minor to major diameter of thebody 126 over 360 to 720 degree revolutions. In one embodiment, the junction of thebody 126 and key 124 provides a torque-limitingfeature 130 to allow the key 124 to break from thebody 126 to prevent stripping the threaded interface between thepost 120 andcap 150 or over-tightening theclamp 10. In one embodiment, the ribs orthreads 128 alongpost 120 are pliable and resilient due to material elasticity. Such pliable, resilient ribs orthreads 128 allow thecap 150 to be quickly secured by ratchetingcap 150 along thethreads 128 on thepost 150 to quickly position thecap 150 relative thebase 100 alongpost 120. Due to the elasticity in engagement of the ribs or threads, however, once thecap 150 is ratcheted in position alongpost 120, it can be further adjusted towardbase 100 by threaded rotation or further ratcheting. Further, in one embodiment,threads 128 can extend partially along theelongated body 126 of thepost 120. In this manner, thecap 150 can be slid along a portion of theelongated body 126, which may include ribs, prior to engaging thethreads 128. - The
head 122 is preferably a rounded disk shape disposed coaxially with theelongated body 126, which flares outwardly at the junction with thehead 122. In one embodiment, the key 124 is a generally D-shaped cross section formed at the second end of thepost 120. In other embodiments, the shape or cross section of the key 124 may differ. Whenclamp 10 is assembled for use, thepost 126 is received coaxially through theaperture 102 of the base 100 such thathead 122 seats in thecentral recess 106, as best shown in FIG. 3. - The
cap 150 fastens to the base 100 to secure the bone plate 18 in place and occlude the burr holes 12. As shown in FIGS. 6-9, thecap 150 is a generally solid disk with anouter face 152 except for acentral recess 154 disposed coaxially about acentral aperture 156 extending therethrough. Thecap 150 has an annularinner face 160 including acollar 158 surrounding theaperture 156. Theinner face 160 comprises an arcuate channel coaxially surrounding thecollar 158 andaperture 156. Further, theinner face 160 includes a series ofradial teeth 162 radiating circumferentially toward the outer diameter of theinner face 160. Theteeth 162 form aserrated edge 164 about the periphery ofcap 150. Theteeth 162 are disposed at an angle I and height H along theserrated edge 164. For example, in an approximately 14millimeter cap 150, theteeth 162 are separated by an angle I approximating 53 degrees at a height H approximating 0.047 inches. In the embodiment shown, theaperture 156 ofcollar 158 includesinternal threads 166. For this embodiment, the threads are left-handed, but should compliment thethreads 128 of thepost 120 in other embodiments. - As shown in FIGS. 1, 3,12 and 13, the
applier 170 is used to position and fasten theclamp 10. Theapplier 170 includes a generally hexagonalelongated body 172 including abore 174 extending generally coaxially therethrough along its length. At a first end, thebore 174 extends to anopening 176. At an opposite end, thebore 174 extends to akeyed bore 178. In one embodiment, keyed bore 178 has a generally D-shaped cross section to compliment the cross section ofkey 124. When key 124 is inserted into keyedbore 178, rotation ofbody 172 rotates thepost 120. In one embodiment, theapplier 170 is secured to thepost 120 prior to use in securing a bone plate 18 by deforming a portion of thepost 120 extending through thekeyed bore 178 and into thebore 174. This deformation, indicated as 132 in the drawings, secures thepost 120 andapplier 170 to one another. As shown, thebody 172 of the applier has a generally hexagonal cross section, but in other embodiments can have other shapes and cross sections. Further, bore 174 tapers tokeyed bore 178 at an angle θ. In this embodiment, angle θ approximates 118 degrees. Also in this embodiment, bore 174 extends approximately 90 percent of the length ofapplier 170, while keyed bore 178 extends approximately ten percent thereof. - In one embodiment, clamp10 includes resorbable materials. In one variation of this embodiment, the
base 100,post 120, and cap 150 are all comprised of resorbable materials. In another variation, thebase 100 andcap 150 are comprised of resorbable material, while thepost 120 is comprised of a suitable biocompatible material. In yet another variation, either the base 100 orcap 150 is comprised of resorbable material, and thepost 120 may be comprised of resorbable and/or biocompatible material. Alternatively, only thepost 120 comprises resorbable material. The main benefit of using resorbable material is that theclamp 10, or components thereof, will resorb into the body over a generally predictable time period once a sufficient level of healing has occurred, for example, at the junction of a bone fracture, thus negating need for subsequent removal of theclamp 10. - One resorbable material is used in products marketed by Biomet, Inc. (Warsaw, Ind.) under the trademark LACTOSORB®. LACTOSORB® is an absorbable co-polymer synthesized from all natural ingredients: 82 percent L-lactic acid and 18 percent glycolic acid. Unlike the homopolymers in common use, such as 100 percent poly-L-lactic acid (PLLA) or 100 percent poly-glycolic acid (PGA), LACTOSORB® co-polymer is substantially amorphous (i.e., without crystallinity), meaning that its degradation is uniform, precluding the crystalline release most often associated with degrading homopolymers that have been associated with inflammatory reactions. Furthermore, the LACTOSORB® co-polymer ratio permits the polymer to retain most of its strength for six to eight weeks, which is appropriate for healing, but not so long as to raise concerns about long-term stress shielding. It should also be understood that any other type of resorbable material may also be used herein.
- In an alternate embodiment, the
clamp 10 includes of non-resorbable, biocompatible materials. In one variation of this embodiment, thebase 100,post 120 andcap 150 are all comprised of non-resorbable, biocompatible materials. In another variation, thebase 100 andcap 150 are comprised of resorbable material, while thepost 120 is comprised of a suitable non-resorbable, biocompatible material. In yet another embodiment, either the base 100 orcap 150 is comprised of resorbable material, while the other of thebase 100 andcap 150 and thepost 120 may be comprised of a suitable non-resorbable, biocompatible material. Alternatively, both thebase 100 andcap 150 comprise non-resorbable, biocompatible material and thepost 120 comprises resorbable material. - One non-resorbable, biocompatible material is titanium. Titanium and its alloys are high strength, durable and corrosion resistant materials. A titanium containing alloy such as, for example, Ti6Al4V is commonly used in surgical applications. Ti6Al4V is inert to human body fluids thus its resistance in bodies is very high. Furthermore, Ti6Al4V has been shown to have a high resistance to abrasion and also has a high fatigue resistance. It should be understood that any other suitable type of non-resorbable, biocompatible material may also be used herein and should be considered within the scope of the present invention, including other metals having a layer of biocompatible cement to line the metal in order to prevent the body's immune system from rejecting the implanted material.
- The
clamp 10 according to the invention can be assembled in various ways for use in replacing the bone plate 18 following a craniotomy. For example, theclamp 10 can be provided unassembled for use in securing the bone plate 18, in which case a user would begin assembly ofclamp 10 by inserting thepost 120 into thebase 10. In another embodiment, theclamp 10 may be provided to the user at least partially assembled, for example with thepost 120 assembled to thebase 100, or otherwise affixed thereto. In another embodiment, theclamp 10 would be assembled further by not only assembling thepost 120 andbase 100 to one another, but also connecting thepost 120 to thecap 150. In this way, once theclamp 10 is in position to secure a bone plate 18, theapplier 170 is connected to thepost 120 for securing the bone plate 18 to the surroundingcranium 28. In yet another embodiment, theclamp 10 includes assembling thepost 120 to thebase 100 andcap 150, as well as securing theapplier 170 to thepost 120. Thepost 120 may be secured to theapplier 170 in various ways; as shown, an end portion of thepost 120 extending through the key shapedbore 178 and into thebore 174 is deformed after assembly of thepost 120 to both thebase 100 andcap 150, whereby the entire assembly of thebase 100,post 120,cap 150, andapplier 170 is provided assembled for use in replacing the bone plate 18 following the craniotomy. - The
clamp 10 is used to replace the bone plate 18 following a craniotomy, as shown in FIG. 1. The craniotomy is performed by providing at least one craniotomy hole or multiple holes, such as burr holes 12, through the skull. The burr holes 12 are subsequently connected byosteotomies 14 to create a separation border for the bone plate 18, which may be a plate that is removed or a flap that is folded back along one edge. Alternatively, a circular bone plate 18 can be formed by providing oneburr hole 12 and a circular osteotomy beginning and ending at the oneburr hole 12. In each case, the craniotomy opening includes aportion 12a of at least oneburr hole 12 formed in the bone plate 18 and acomplimentary portion 12b of the hole formed in the surroundingcranium 28. The subsequent description employs the example of multiple burr holes 12 andosteotomies 14 connecting theholes 12, as shown in FIG. 1. - As shown in FIG. 2, the bone plate18 has the
internal surface 20 and external surface 22 respectively placed in substantially coplanar relationship with theinternal surface 24 andexternal surface 26 of the surroundingcranium 28 when a craniotomy is closed. Opposing transverse faces 30, 32 of the bone plate 18 and surroundingcranium 28 appose along the separation border when the bone plate 18 is replaced. Faces 30, 32 are generally parallel to each other when in apposition. - In a method of the present invention, the bone plate18 is folded back along a base 16 or completely removed to expose the underlying dura matter and brain. In one embodiment, following the intracranial procedure, and prior to replacing the bone plate 18 into its original orientation within the craniotomy opening, the assembled
base 100 and post 120 is placed below eachburr hole 12 with theinner face 104 of the base 100 against theinternal surface 24 of thecranium 28 and thepost 120 extending through thehole 12. The base 100 overlaps the margins ofhole 12 and the separation border between the bone plate 18 and surroundingcranium 28. Thecollar 110 projects upwardly toward thehole 12 and thepost 120 extends upwardly and through thehole 12. In another embodiment, the assembledbase 100,post 120, and cap 150 are positioned with theinner face 104 and the base 100 against theinternal surface 24 of thecranium 28, thepost 120 extending through thehole 12, and thecap 150 positioned above thehole 12 with theinner face 160 of thecap 150 facing theexternal surface 26 of thecranium 28. In yet another embodiment, theapplier 170 is connected to thekeyed end 124 of thepost 120 such that the assembledbase 100,post 120,cap 150, andapplier 170 are positioned relative each borehole 12 with theinner face 104 of the base 100 against theinternal surface 24 of thecranium 28, thepost 120 extending through thehole 12, and theinner face 160 of thecap 150 facing theexternal surface 26 of thecranium 28. The bone plate 18 is then replaced into the craniotomy opening, for example, by folding the bone plate 18 alongbase 16 back down into the craniotomy opening. - After the bone plate18 is restored to its original position in the craniotomy opening,
complimentary portions reform hole 12. Thepost 120 is positioned withinhole 12 with theinner face 104 of the base 100 engaging theinternal surfaces cranium 28, respectively. If not already assembled to thepost 120, thecap 150 is positioned over the reformedhole 12 to engage thepost 120 above thehole 12. Thepost 120 is introduced into thecollar 158 ofcap 150 through theaperture 156. In one variation of this embodiment, wherein thethreads 128 extend generally along the length of theelongated body 126 of thepost 120, the threads of internally threadedcollar 158 engage thethreads 128 of externally threadedelongated body 126 and thecap 150 is threaded into engagement with bone plate 18 and surroundingcranium 28. In another variation of this embodiment, wherein a portion of theelongated body 126 is externally threaded, thecap 150 is slid along an unthreaded leading portion of theelongated body 126 until it engages an externally threaded portion of theelongated body 126. In any embodiment, the ribs orthreads 128 may be pliable and resilient, whereby thecap 150 is ratcheted along the externally ribbed or threadedelongated body 126 into contact with the external surface of thecranium 28 and bone plate 18. - In one embodiment, once the
cap 150 is in position to be threadably driven, theapplier 170 is attached to thepost 120 by inserting the key 124 of thepost 120 into the keyed bore 178 of theapplier 170. In another embodiment, theapplier 170 is connected to thepost 120 prior to positioning thepost 120 on theburr hole 12. In each embodiment, thecap 150 is held in place with one hand while theapplier 170 is rotated with the other hand, causing thepost 120 to rotate relative thebase 100 and threadedly engage thecap 150 to diminish the distance between the base 100 and thecap 150 and tighten respectiveinner faces base 100 andcap 150 against the respective internal and external surfaces of thecranium 28 and bone plate 18. Thecap 150 andbase 100 are brought together in frictional engagement against opposing faces of the bone plate 18 and surroundingcranium 28, thereby clamping the bone plate 18 and surroundingcranium 28 to each other. Theteeth 162 of thecap 150 anchor thecap 150 to both the bone plate 18 and surroundingcranium 28, thereby preventing rotation of thecap 150 while thebase 100 is secured thereto. Thecap 150 is attached to the bone of the bone plate 18 andcranium 28 as theteeth 162 become progressively advanced into the bone by rotating theclamp 10. - The torque-limiting
feature 130 disposed at the junction of thebody 126 andkey 124 of thepost 120 allows the key 124 to break from thebody 126 to prevent stripping the threaded interface of thepost 120 andcap 150 or overtightening thecap 150 relative thebase 100. The key 124 will separate from thebody 126 of thepost 120 before the threaded interface between thecap 150 and post 120 strips. In this manner, the time and expense of replacing a strippedclamp 10 is avoided, and a proper amount of frictional engagement of thecap 150 andbase 100 against opposing faces of the bone plate 18 and surroundingcranium 28 is provided. The torque-limitingfeature 130 of thepost 120 could be provided in other ways within the scope of this invention, such as by notching thepost 120 at a portion other than the junction of the key 124 andbody 126, or narrowing the diameter of thepost 120 at any point along thebody 126 and key 124, among other ways. - After the
cap 150 andbase 100 are suitably brought together against the opposing faces of the bone plate 18 and surroundingcranium 28 to clamp the bone plate 18 and surroundingcranium 28 to each other, a distal portion of thepost 120 is cut a distance D above thecap 150, as best shown in FIG. 2. The distance D is a distance suitable to provide aproximal portion 140 of thepost 120 with enough material to secure thecap 150 to thepost 120 upon deformation of theproximal portion 140 ofpost 120. In one embodiment, the distance D is approximately two millimeters for a 14millimeter diameter cap 150. The remaining distance D of thepost 120 is flattened or otherwise deformed to prevent thecap 150 from backing off thepost 120 and away from thebase 100. Preferably, opthalmic cautery or a heat pen is used to cut the post a distance D above thecap 150, and further used to deform the remaining distance D of thepost 120 to secure thecap 150 relative thebase 100, as best shown in FIG. 1. A heat pen, such as the LACTOSORB® Heat/Contouring Pen, is available from W. Lorenz Surgical of Jacksonville, Fla. - The
clamp 10 is used to clamp the bone plate 18 to the surroundingcranium 28 at one or more of the burr holes 12, and preferably all of the burr holes 12 as shown in FIG. 1. Theclamp 10 can also clamp the bone plate 18 to the surrounding cranium along anosteotomy 14. That is, use of theclamp 10 is not limited to occluding burr holes 12, but is useful for supporting a bone plate 18 in a circular orcurved osteotomy 14 as well. Abase 100 and post 120 is therefore positioned below eachburr hole 12 or at discrete points along an osteotomy with thepost 120 projecting up into and through thehole 12 on the line of separation prior to replacement of the bone plate 18. Acap 150 is then threaded along each externally threadedpost 120 until thecap 150 andbase 100 clamp the bone plate 18 and surroundingcranium 28 securely to each other. Thecap 150 andbase 100 are in a fixed relationship determined by the degree of advancement of the externally threadedpost 120 into the internally threadedcollar 158 of thecap 150, so that the movement of the bone plate 18 is substantially prevented. The bone plate 18 and surroundingcranium 28 are held firmly in place with respect to each other, which avoids inadvertent depression of the bone plate 18 and attendant catastrophic neurological consequences. - The outer face of the
cap 150 diminishes the aesthetic problem of visible indentations on the skull or face overlying the craniotomy burr holes 12. Further, by employing a malleable material with high ductility for thecap 150, aesthetic problems are further reduced. Theclosed base 100 tightly engages the internal surfaces of the bone plate 18 and surrounding cranium providing ideal occlusion of thehole 12 to held avoid infection or trauma. Theclamp 10 also clamps the bone plate 18 in place quickly, thereby diminishing the period of time the brain must be exposed and also reduces medical expenses associated with prolonged time in the operating room. In one embodiment, as explained previously, theclamp 10 is made partially or wholly of resorbable material so that the body can resorb the clamp after suitable bone growth across the osteotomies. Beside the biocompatibility of such materials, such aclamp 10 need not be removed by a follow-up neurosurgical procedure. - The
clamp 10 may be made in many different sizes. For purposes of illustration, the diameter of thepost 120 can be 1.8 millimeters (the same diameter as theapertures 156 and 102), the diameter ofbase 100 can be 14 millimeters, and the diameter of thecap 150 may be 14 millimeters. In one embodiment, thepost 120 is 35.6 millimeters long, withkey 124 extending approximately 5 millimeters from a leading end of thepost 120. - The
clamp 10 is adjustable for use in repairing craniotomies through bone of varying thickness. The pterion (in the temporal-parietal region), for example, is quite thin and would conventionally require a shorter fastener. Because the unused portion of thepost 120 is simply removed once the base 100 andcap 150 are appropriately positioned, different-sized fasteners are not necessary. For example, the parietal or frontal bone may be 10 to 20 millimeters thick, wherein the present invention would work properly with both bone thicknesses, as well as smaller or larger thicknesses. - Other variations of the disclosed fastener are possible. The relative positions of the cap and base can be reversed, for example, by disposing the
cap 150 on the interior surface of the cranium and bone plate 18 while thebase 100 is disposed along the external surfaces thereof by simply threading thecollar 110 of thebase 100 and leaving thecollar 158 of thecap 150 unthreaded. Thecap 150 andbase 100 may assume many shapes other than circular, and may, for example, be square or triangular. Bone plates other than in the skull may be secured to surrounding bone, for example, a relatively flat top bone such as the trapezium, mandible, maxilla or bones of the orbit. The outer face of thecap 150 may also be flat, particularly in areas of the skull, such as the temporal bone, with relatively flat external surfaces. The fastener may also be used to fix adjacent members together, even where the members are curved. A malleable material may be used to accommodate differing surface shapes. Such materials include LACTOSORB® copolymer, VHMN polyethylene, polyethyl ketone, silicone, nylon, etc. - In one embodiment, the base and cap may include
flexible struts 200 to provide more flexibility than a solid member, as shown in FIG. 14 forexemplary base 100′. Thestruts 200 are preferably made of a high-density polyethylene. In the disclosed embodiment, eachstrut 200 does not occupy more than about a 20 to 30 degree sector of the base or cap. Thestruts 200 radiate from the center of the cap or base to a peripheral ring, but they can alternatively taper, flair, or assume other shapes that sufficiently reduce the solid areas of the base and cap to increase the flexibility such that it conforms to the curvature of the skull when the clamp is tightened to such an extent that the bone in the skull is not fractured or damages. For example, the modulus of flexibility of the cap or base, or each individual strut, is 300,000 to 700,000 PSI. - In yet another embodiment shown in FIGS.15-17, the
clamp 10 includes a first member orbase 100″ selectively connected to a second member orcap 150″ via apost 120″. As before, thecap 150″ andbase 100″ are brought toward one another by an instrument orapplier 170. The base 100″ is formed by a generally solid disk having acentral aperture 102″ for rotatably receiving thepost 120″. Similar reference numbers are used in this description to note features similar to those described for the prior embodiments. - The
post 120″ includes ahead 122″ at a first end and a key 124 at a second end. A substantially cylindricalelongated body 126 extends between thehead 122″ and the key 124, and generally includes ribs orthreads 128 along its length. As before,threads 128 are used in the description, but ribs are within the scope of the invention. Thehead 122″ of thepost 120″ includes achannel 121 for receiving aperiphery 103 of theaperture 102″ in order to rotatably secure the base 100″ to thepost 120″.Slots 105 allow deflection of the base 100″ at theperiphery 103 to facilitate insertion of thehead 122″ in theaperture 102″, whereby theperiphery 103 is received in thechannel 121. In this manner, as described in prior embodiments, thepost 120″ is able to rotate relative the base 100″. - The
cap 150″ is a generally solid disk having a central aperture disposed coaxially therethrough for receiving thecollar 110″. Thecollar 110″ includes acentral aperture 156″ extending therethrough and includinginternal threads 166 that mate with thethreads 128 on thepost 120″. Thecollar 110″ includes aflange 157 to prevent pulling thecollar 110″ through thecap 150″ during assembly or use. Thecollar 110″ is press fit into the aperture 159 of thecap 150″, whereby thecollar 110″ andcap 150″ rotate together. Alternatively, thecollar 110″ andcap 150″ could be threaded together where the threaded engagement between thecollar 110″ andcap 150″ is an opposite thread to that of the engagement between theinternal thread 166 of thecollar 110″ and thethread 128 of thepost 120″. - In a variation of this latter embodiment, the
collar 110″ can be acollar 110″ that is formed integral with acap 150″, as shown in FIG. 17. The operation and use of this variation of the invention is similar to that described for the previous embodiment of the invention, and the inventions shown in FIGS. 15-17 are used and assembled in manners similar to that described above for the prior embodiments. - As used in this specification, conformance to a curved member does not require identical curvature of the conforming member at the surface to which it conforms. Substantial conformity of the members is all that is required, and that includes surfaces between flat planes and curves that precisely conforms to the curved member against which the conforming member seats.
- The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.
Claims (27)
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Also Published As
Publication number | Publication date |
---|---|
US6685707B2 (en) | 2004-02-03 |
US20030125743A1 (en) | 2003-07-03 |
JP2006500156A (en) | 2006-01-05 |
WO2004028384A1 (en) | 2004-04-08 |
AU2003236498A1 (en) | 2004-04-19 |
EP1549236A1 (en) | 2005-07-06 |
EP1549236A4 (en) | 2006-07-26 |
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