CA2201087A1 - Surgical bone fixation apparatus - Google Patents
Surgical bone fixation apparatusInfo
- Publication number
- CA2201087A1 CA2201087A1 CA002201087A CA2201087A CA2201087A1 CA 2201087 A1 CA2201087 A1 CA 2201087A1 CA 002201087 A CA002201087 A CA 002201087A CA 2201087 A CA2201087 A CA 2201087A CA 2201087 A1 CA2201087 A1 CA 2201087A1
- Authority
- CA
- Canada
- Prior art keywords
- bone
- leg portion
- hole
- plate member
- fixation apparatus
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 249
- 239000000463 material Substances 0.000 claims abstract description 26
- 238000004873 anchoring Methods 0.000 claims abstract description 3
- 238000000034 method Methods 0.000 claims description 11
- 230000035876 healing Effects 0.000 claims description 9
- 238000003780 insertion Methods 0.000 claims description 5
- 230000037431 insertion Effects 0.000 claims description 5
- 230000013011 mating Effects 0.000 claims 2
- 210000004872 soft tissue Anatomy 0.000 abstract description 21
- 238000012986 modification Methods 0.000 description 12
- 230000004048 modification Effects 0.000 description 12
- 230000001815 facial effect Effects 0.000 description 9
- 210000002435 tendon Anatomy 0.000 description 9
- 208000010392 Bone Fractures Diseases 0.000 description 8
- 238000001356 surgical procedure Methods 0.000 description 8
- 210000001519 tissue Anatomy 0.000 description 8
- 229920000642 polymer Polymers 0.000 description 3
- 210000003625 skull Anatomy 0.000 description 3
- 101100345589 Mus musculus Mical1 gene Proteins 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 239000012634 fragment Substances 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000013508 migration Methods 0.000 description 2
- 230000005012 migration Effects 0.000 description 2
- 229910000684 Cobalt-chrome Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000003190 augmentative effect Effects 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 238000002316 cosmetic surgery Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000005553 drilling Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000003054 facial bone Anatomy 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 210000000513 rotator cuff Anatomy 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
Classifications
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/808—Instruments for holding or positioning bone plates, or for adjusting screw-to-plate locking mechanisms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
-
- 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
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/809—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with bone-penetrating elements, e.g. blades or prongs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8085—Cortical 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0403—Dowels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0645—Surgical staples, i.e. penetrating the tissue being elastically deformed for insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Surgical Instruments (AREA)
Abstract
A bone fixation apparatus for anchoring a surgical member to bone for the fixation of bone or soft tissue to bone. The bone fixation apparatus includes a post device having a leg portion slidably insertable into a hole formed in bone. The leg portion is of sufficient length relative to the interior diameter of the hole to resist removal of the leg portion from the hole when forces substantially parallel to the outer surface of the bone are applied to the post device to anchor the surgical member to bone. In one aspect of the invention, the surgical member is a plate section of an elongated sheet of surgical plate material which may be divided into a plurality of plate sections each having an arbitrary shape.
Description
~ 1 ~ ~Q~ ~7 SURGICAL BONE FIXAT~ON APPAR~TUS
Brief Description of the Invention This invention relates in general to a surgical bone fixation apparatus and, more particularly, to an apl)a~ s for the fixation of bone and soft tissue to bone.
Background Qf the Invention Various surgical plates have been employed in the treatment of traumas to facial or cranial bone structure, plastic surgery, reconstructive facial surgery, and the like to hold the bone sections or fragments in place during the healing process. The surgical plates are positioned against the surface of the bone sections which must be held together and fixed to the bone by 10 mP~h~nical r~Le~ such as bone screws, wire sutures or other fasteners which secure the plate to the bone surface. The fasteners are securely pressed or embedded in the bone to prevent the surgical plates from being pulled away from the surface of the bone sections. U.S. Patents 4966,599 and 5,290,281 disclose examples of bone stabilization plates which are secured to the bone structure, for example facial or cranial bones, by bone screws. U.S. Patent 4,655,203 15 discloses a surgical device for immobilization of bone fracture which includes a stiffplate and stiff fixing elements which may be pressed into notches formed in the bone.
In such procedures as rotator cuff surgery and hand tendon surgery, tendons or other soft tissues are fixedly secured to bone. The tendons or other tissue are o~cen secured to bone by feeding the soft tissue through holes formed in the bone and suturing the tissue in place. Another 20 method of securing soft tissue to bone employs a fixation device which essentially tacks the tendon to bone. Unless the tendon or other soft tissue is completely irnmobilized, the fixation device must be securely embedded in the bone to hold the tendon stationary against the bone surface, resisting those forces tending to pull the tendon away from the bone surface, until the tendon has become attached to the bone. Another method of securing tendons and other soft tissue to bone uses a fixation device with an ~t~ched suture. Once again, the fixation device must be securely embedded in bone to resist forces tending to pull the tissue away from the bone surface. In various facial surgery procedures, soft tissue is surgically lifted or moved and then secured to bone by suturing and the like to hold the tissue in the desired position during the S healing process. These tissues are generally subjected only to gravitational forces or other forces parallel to the surface of the bone, they are not exposed to forces tending to pull the tissue outwardly away from the bone.
Surgical plates must be securely affixed to bones which may be exposed to various tensile and bending forces during the healing process to prevent the plate from being pulled outwardly 10 away from the bone. If the fasteners do not securely engage the bone, the applied stresses may have a tendency to pull the fasteners from the bone. Facial and cranial bone sections, on the other hand, are genel~lly not exposed to such tensile and bending stresses. Tn~te~ the bone sections are primarily subjected to forces tending to spread the bone sections apart or to cause lateral slippage of the bone sections along the fracture line. Since the applied forces are subst~nti~lly 15 parallel to the bone surface, the fasteners need only anchor the surgical plates to the facial or cranial bones to hold the bone sections in place. The additional security provided by securely embedding the f.q.stener in bone and actually securing the plate to the bone surface is often not required with facial and cranial bones and of bones at other sites.
Securely embedding screws, nails and the like in bone is a time con~uming and labor 20 intensive process, considerably extending the time required to complete the operation. Even when the fasteners are initially inserted into pre-drilled holes, care must be taken to ensure that the desired o~ ;on ofthe fasteners is /~ e~l Moreover, embedding the fasteners in bone may subject the relatively fragile facial bones to additional unnecessary stress. Surgical fasteners such as screws and the like require expensive m~nllf~cturing techniques because ofthe small size 25 of the fastener. Mi~ g the size of the plate and fastener would ...il~ -i,e the size of the surgical area and the amount of bone which must be exposed. However, the reduced size of the screws and other Ç~lellel~ is limited because the fasteners have sufflcient strength to engage bone and securely attach the plate to the bone. Using a fixation device which anchors the surgical plate ~ 2 ~ 7 to the bone, but does not securely affix the plate to the bone surface, would avoid the disadvantages ~soçi?~ed with embedding the fastener in bone. Such a fixation device would also be particularly useful in other types of procedures where the fixation ~pa~ s may be employed to afflx soft tissue to bone.
The surgical plates and associated fasteners employed for bone fixation have been fabricated of materials such as titanium, stainless steel, vitalium, chrome cobalt, and suitable bio-co,l,l,alible polymeric materials. Unless removed by surgery, the plates and fasteners formed of these materials permanently remain in the patient's body. The surgical plates and internal f~tening IllClllbt;l:i may cause various unpredictable problems if left intact as the bone dynamically reacts to the foreign bodies over time by molding to the shape of the foreign body, forming deposits on the foreign body, and responding to stress. The foreign bodies also provide potential cites for infection. Migration of the foreign body presents another problem if the surgical plate and/or f~tçners are left in the patient's body. This problem is of particular concern when the patient is an infant or young child, where the considerable amount of skull growth has resulted in significant migration offoreign body to the extent where the plate has entered the brain.
Forming the plate and/or r~lei,e,~ of a material which may be absorbed by the body over time would aUow the foreign materials to be removed from the patient's body without requiring a second operation. U.S. Patents 5,655,203,4,905,680, 4,966,599,5,275,601 and 5,290,281 describe rulll~ing ~e surgical plates and/or fasteners of absorbable materials. Fabricating a bone screw or other tner.h~nical fastener out of absorbable polymers is often difficult because the absorbable fastener has a tendency to prematurely slip from the bone. Moreover, because of their reduced size, forming absoll,ablc bone screws for the fixation of plates to facial and cranial bones is even more difficult. To achieve the desired strength, the absorbable screws must be larger in size than a colll~le metal screw. A fixation device for the fixation of surgical plates to bone which may be easily m~m ~f~ct Ired of an absorbable material and reliably used is highly desirable.
Objects and Summary of the Invention It is a primary object ofthis invention to provide a bone fixation apparatus for the surgical fixation of bone or soft tissue to bone.
r -It is another object of this invention to provide a bone fixation appa~ ls for anchoring a surgical plate, suturing element or other surgical member to bone.
It is yet another object ofthis invention to provide a bone fixation al)pal~Lus which may be quickly and easily applied to bone by the surgeon without subjecting the bone to unnecessary 5 stresses.
It is stil~ another object ofthis invention to provide a bone fixation a~pal~ s in which the size ofthe post fixation device may be l~ ed It is a further object of this invention to provide a bone fixation appal al~ls which may be fabricated of materials which are absorbed by the body over time.
A more general object ofthis invention is to provide a bone fixation apparatus which may be economically m~mlf~ctl-red and which may be efficiently and reliably employed in the fixation of surgical plates, suturing elements and other surgical members to bone.
In summa~y, this invention provides a bone fixation apparatus which is particularly suitable for use in the fixation of bone and/or soft tissue to bone. In one modification of the invention, 15 the bone fixation appa.~ s generally includes at least one post device having a leg portion configured for re1easable insertion into a hole formed in bone. The leg portion is of sufflcient length relative to the interior (1i~meter of the hole to resist removal of the leg portion from the hole in the bone when forces substantially parallel to the outer surface of the bone are applied to the post device. The post device anchors a surgical member, such as a surgical plate or suturing 20 element, to bone. In another modification of the invention, the bone fixation device includes a continuous, elongated sheet of surgical plate material which is divisible into a plurality of plate members each having an albiL,~y length. The plate members are mountable to the bone by f~tening devices such as the post device.
Additional objects and features of the invention will be more readily apparenl from the 25 following detailed description and appended claims when taken in conjunction with the drawings.
Brief Description of the Drawin~s Figure 1 is an e~ ,ed, fragmentary, cross sectional view of a bone fixation apparatus in accordance with this invention, shown fixed to two bone sections.
Figure lA is an enlarged, fragmentary view of a modified post device.
Figure 2 is an enlarged, fragmentary, top plan view of the bone fixation appaldl-ls and bone sections of Figure 1.
Figure 3 is an enlargéd, fr~ment~ry, top plan view of a bone fixation appa~allls in S accordance with another embodiment of the invention.
Figure 4 is an enlarged, fragmentary, top plan view of a bone fixation appdldllls in accordance with yet another embodiment of the invention.
Figure 5 is a fr~nçnt~ry, cross sectional view taken along line 5-5 of Fig 4.
Figures 6 and 6A are schematic, top plan views of a bone fixation a~ aldlus in accordance with another embodiment of the invention.
Figure 7 is an enlarged, side elevational view of a bone fixation apparatus in accordance with another e~ ent of the invention.
Figure 8 ~s an enlarged, side elevational view of the bone fixation a~pa~ s of Figure 7, shown during ~p~l;G~ n of the apparatus to the bone sections.
Figures 9 is a schematic, fi~ . y, side elevational view of a bone fixation appaldLus in accold~lce with another embodiment of the invention, shown securing soft tissue to bone.
Figures 1~12 are fra~rnent~ry, side elevational views of other modifications of the bone fixation app~dlus shown in Figure 9.
Detailed Description of the Invention R~rt;l~ncewill now be made in detail to the preferred embodiment of the invention, which is illustrated in the accoml)~lying figures. Turning now to the drawings, wherein like components are de~iig~.~led bylike reference numbers throughout the various figures, attention is directed to Figures 1 and 2.
A bone fixation apparatus 10 incorporating this invention may be used for the fixation of bone or soft tissue to bone. In the modification of Figures 1 and 2, the bone fixation apparatus 10 is shown holding two bone sections 6 and 7 in a desired position about a fracture line or incision, generally design~ted 8. Fixation apparatus 10 may be used with any type of bone structure as for example cancellous bones with marrow 9, bones without marrow such as the walls ofthe sinus, and the skull which includes an outer table, an inner table and marrow between the inner and outer tables. Preferably, the fixation apparatus 10 of the invention is used with bones which are subjected primarily to forces parallel to the bone surface, such as those which tend to sepa ~l~ the bone sections or cause relative lateral movement of the bone sections. The bones are generally isolated from forces transverse to the bone surface and are not required to carry a significant load. Examples of such bones include the facial and cranial bones, although it will be understood that use ofthe bone fixation apparatus may also be used with other suitable bones.
In the embodiment shown in Figure 1, bone fixation apparatus 10 includes a surgical plate member 12 extending across the surface of the bone and post devices 14 ret~inin~; plate member 12 in place. The shape, size and thickness of plate member 12 is subject to considerable modification depending upon the location of bone sections 6 and 7, the size of fracture line 8, the characteristics ofthe material of plate member 12, the characteristics and desired result of the surgical procedure employing the appa~ s and the like. Surgical plate member 12 is anchored 1~ to each bone section by at least one post device 14. In many applications, using one post device 14 per bone section as shown in Figures 1 and 2 will sufficiently retain the bone sections in the desired position. However, using more than one post device for at least one of the bone sections offers the advantage of increased stability and augmented parallelographic force. For example, Figure 3 shows a modification ofthe invention where one post device 14a anchors plate member 12 to bone section 6 and two post devices 14b and 14c anchor the plate to bone section 7. The positioning of post devices 14a, 14b and 14c creates a tri~n~ll~tion effect which substantially resists relative lateral movement of the bone sections along the fracture line. Instead of using three post devices 14 for enhanced stability as shown in Figure 3, a greater number of post devices 14 may be employed if desired.
Eadditional security is desired~ plate member 12 may be secured to bone by replacing one ofthe post devices 14, for example post device 14a shown in Figure 3, with a screw or other suitable fastener which securely engages the walls of hole 24 to attach the plate member to the surface of the bone section. The rem~ining post devices, such as post devices 14b and 14c, ~ 7 anchor the plate member 12 to the other bone section to retain the bone sections in the desired position.
As shown in Figure 1, post device 14 includes an enlarged cap or end portion 16 and a leg portion 18 depending from the underside 20 of end portion 16. The leg portion 18 extends S through an aperture 22 formed in plate member 12 and is positioned in a hole 24 formed in bone sections 6 and 7 to anchor surgical plate 12 to the bone sections. Unlike the fixation devices of the prior art, post device 14 is not intended to prevent the surgical plate 12 fiom being pulled away from the surf~ce ofthe bone sections. Instead, post device 14 substantially resists forces parallel to the surface of the bone, such as those tending to separate the bone sections or cause 10 lateral slippage along the fracture line, to hold surgical plate 12 in place. Leg portion 18 is formed of sufflcient length relative to the interior diameter of the hole 24 to resist those forces parallel to the bone surface. The optimum length for leg portion 18 depends in part on such factors as the stif~ess ofthe material used in the fabrication of post device 14 and the m~gnitucle of the forces applied to the post device. For many applications, a length of at least about two 15 times the interior rli~meter of the hole 24 will be suff~cient to prevent forces parallel to the bone surface from deforming the leg portion and pulling the leg portion 18 from the bone. However, it will be l-n~l~rs~ood that in some applications of the invention it may be desirable to provide leg portion 18 with a lesser or greater length or angle.
Since it is the length ofthe leg portion 18 which holds the post device 14 in the hole and 20 anchors the plate member 12 to the bone sections~ leg portion 18 may be shaped so that only a minimllm amount of pressure is required to slip the leg portion into the hole 24. The leg portion 18 is not securely embedded in place, but is instead movable in a direction parallel to the axis of the hole. The exterior of leg portion 18 may be substantially cylindrical as shown in Figure 1, or, if desired, leg portion 18 may be configured to provide a limited area of engagement between the 25 exterior ofthe leg portion and the walls of hole 24. For example, Figure lA shows a modification of post device 14 having a slightly bowed or spindle-shaped cross section, although it is to be understood that leg portion 18 may have other cross sectional shapes if desired. Moreover, the area of limited enga~ement need not extend around the entire circumference of the leg portion 1~. Tn~te~tl, leg portion 18 may be formed with one or more projections which are configured to slightly engage the interior wall of hole 24.
The m~iml-m ~ .,.ete~- ofthe spindle-shaped leg portion shown in Figure lA is preferably equal to or slightly greater than the interior diameter of the hole 24 so that when the post device 5 14 is initially inserted in the hole, the leg portion will partially engage the wall of the hole.
Although the limited engagement between the leg portion and wall of the bone is generally insufflcient to securely retain the post in the hole 24, the spindle shape of leg portion 18 allows the surgeon to conveniently manipulate the surgical plate relative to the bone sections during the surgical procedure without pulling the post device from the hole 24. Since only a limited area of 10 leg portion 18 engages the walls of the bone, the pressure required to insert the post device 14 into hole 24 is not significantly increased.
As is shown particularly in Figure 1, leg portion 18 is preferably oriented at an angle of about 15 to 55 degrees relative to the underside 20 of the end portion 16. For optimum effectiveness, the angled leg portion 18 is inserted into a hole 24 e~ct~.n-ling into the bone at 15 app-ox;. ~ l~lr3y the same angle as the inclin~tion of leg portion 18 so that the underside 20 of the end portion engages the upper surface of the plate member 12. Aperture 22 may also extend through plate ,llt;"d~er 12 at an angle. When post device 14 is inserted in the bone, the angled leg portion 18 is ~lert;l~bly oriented so that the tip of the leg portion points in a direction opposite the forces applied to the bone section. For example, in Figure 1 the angled leg portion 18 is 20 oriented illw~udly toward the fracture line, extending in a direction opposite those forces tending to pull the bone sections 6 and 7 apart.
Providing post device 14 with a slanted leg portion increases the stability of bone fixation apparatus 10 in resisting forces parallel to the bone sections 6 and 7. When positioned as shown in Figure 1, the slanted leg portions of the post devices 14 on opposite sides of the fracture line 25 may also be used to urge the bone sections 6 and 7 together. Urging the bone sections together with post devices 14 ensures the bone sections are held together, f~çilit~ting the healing process.
Although angled leg portions 18 increase the ability of post device 14 to resist forces substantially ~ 7 parallel to the bone sections, it will be understood that the leg portions 18 may also be perpendicular to the underside of end portion 16 if desired.
The bone ffxation apparatus 10 may be applied to the selected bone sections using a suitable surgical technique. Apertures 22 may be forrned in plate member 12 at predetermined locations or, if desired, the surgeon may select the site of the apertures. If desired, the apertures 22 and holes 24 may be formed simultaneously by locating the plate member 12 on the bone sections 6 and 7 and drilling through the plate and bone. However, rO~ g the apertures 22 separately from the holes 24 isolates the wound or surgical site from unwanted surgical plate fragments. The locations of holes 24 may be selected using a template if desired. Preferably, 10 holes 24 are formed using a drill or other appropriate instrument having a stop or collar limiting the hole depth to avoid excess penetration particularly in the skull. When post devices 14 having angled leg portions 18 are employed, the stop is pl erel ably oriented at an angle relative to the drill bit similar to the angle between the end portion 16 and leg portion 18. Alternatively, the stop may be curved for usage with post devices angled or perpendicular to the end portion 16.
The configuration of surgical plate member 12 is subject to considerable variation depending upon the con~t,~;"ls of a particular application. Figure 2 shows a plate member 12 having a s~ ally rect~n~ r shape. The plate member may also have other shapes such as the tri~n~ r shape shown in Figure 3. Figures 4 and 5 show another embodiment of the invention in whicirplate member 12 includes a flange or rib 30 depending from the underside 31 20 of the plate member 12. In the embodiment shown in Figures 4 and 5, the flange 30 extends contimlously along the entire length ofthe plate member. However, flange member 30 may have other configurations if desired. Flange 30 is positioned in a thin groove or cut 32 forrned in the bone to assist in obl~;n-llg the desired positioning of bone fixation appalalus 10 and bone sections 6 and 7 when the apparatus 10 is initially anchored to the bone. The inter-~n~g~ment of flange 25 30 and groove 32 also provides additional resistance against relative lateral slippage between the bone sections 6 and 7. In the modification shown in Figures 4 and 5, four post devices 14 having a spindle-shaped cross section are employed to anchor plate member 12 to bone. The post devices 14 may have slanted leg portions or leg portions subst~nti~lly perpendicular to the plate member 12.
Although not shown, the plate member may also be formed with a curved or steppedcross-section. The curved or stepped configuration may be prefabricated or the plate member 5 may be formed of a suitable material and manipulated into the desired shape by the surgeon or surgical ~x~ The prefabricated plate member may also be formed of a m~t~ l which allows the shape ofthe plate member to be adjusted during the operation.
Figure 6 illustrates a modification of the invention in which plate member 12 comprises a section of an elongated sheet 36 of surgical plate material. The sheet 36 shown in Figure 6 is 10 of sufficient width to allow the surgeon select any shape desired for the surgical plate.
Alternatively, as is shown in Figure 6A the sheet 36 may be formed as a narrow strip of material which may be s~alaled into plate sections of arbitrary lengths. The ability to divide the sheet 36 of plate material into plate sections each having an arbitrary shape provides the surgeon with immediate access to a plate member 12 of appropriate size. The sheet 36 of surgical plate 15 material may be divided into separate plate sections using the appropliate clipping tools for the particular material of sheet 36. Dependillg upon the material employed for surgical sheet 36, the sheet 36 may be retained in a roll or provided as a planar sheet of material. As with the previously described embotlim~nt~, apertures may be pre-formed in sheet 36 or the apertures may be formed by the surgeon at the desired locations. Alternatively, as will be described in greater 20 detail in relation to Figures 7 and 8, sheet 36 may be integrally formed with a plurality of spaced post devices 14.
Turning to Figures 7 and 8, bone fixation device 10 is a monolithic structure in which post devices 14 are integrally formed with plate member 12. In the modification shown in Figures 7 and 8, the leg portions 18 ofthe post devices 14 are oriented at an angle relative to the underside 25 of plate member 12. The fixation appa~ s is applied to bone by d~;roll-l-ng the edges of plate member 12 upwardly as shown in Figure 8 to position the tips 40 ofthe post device above the open ends of the holes 24. Preferably, the upper surface of the plate 12 is concave to f~cilit~te d~rolm~ion ofthe plate to bring the post devices 14 into a substantially parallel orientation. The post devices 14 are then slipped into the holes and the plate member 12 is moved toward the bone surface. The plate member 12 returns to its original shape shown in Figure 7, with the angled post devices 14 providing addition resistance against separation, when the outer edges of the plate member are released and the plate member is positioned against the bone surface. Preferably, a 5 surgicat instrument 41 is used to bend the plate 14 and hold the plate as shown in Figure 8, allowing a nurse or surg,ical te~' ~iciqn to prepare the plate for insertion and allowing the surgeon to manipulate the plate to the desired position. The surgical instrument may also be used to adjust the position of the fixation apparatus or to remove the fixation appal~LIls from the bone.
The post devices 14 anchor the fixation apparatus to bone to retain the bone sections in 10 the desired position during healing. As previously described, the angled leg portions 18 provide increased rç~ict~n~e to oppose forces substantially parallel to the bone surface and retain the bone sections in place. In the present embodiment, the post devices are preferably oriented at an angle of appro~imately 10-20 degrees to ...;~ e the amount of derolllla~ion of plate 12 which is required to insert the post devices 14 into holes 40.
Although slanted leg portions 18 are preferred for increased stability, post devices 14 may also extend in a direction substantially perpendicular to the underside of the plate member 12.
Wlth the pel~ r post devices 14, upward deformation may not be required to ali~,n the tips 40 of the post devices with the holes 24 formed in the bone sections.
In the previously described embodiments ofthe invention, bone fixation appalalus 10 was 20 particularly suitable for the fixation of bone to bone. Figures 9-1 1 show alternative embodiments of the invention where bone fixation apparatus 10 is employed to affix or anchor soft tissue to bone. Turning to Figure 9, bone fixation device 50 includes a post device 52 having an enlarged end portion 53 and a leg portion ~4 which may be slipped into a hole 55 forrned in bone. The leg portion 54 of the post device 52 is of sufficient length to substantially resist forces substantially 25 parallel to the surface ofthe bone, providing an anchor for securing soft tissue to bone. As with the embodiments of Figures 1-8, leg portion 54 is preferably formed so that it slips into hole 55 with minimal force. If desired, the leg portion 54 be shaped to provide a limited area of ~ 7 -engagement with the walls of the hole 55 to allow the surgeon to conveniently manipulate the bone fixation appa~ s 50 without pulling leg portion 54 from hole 55.
A sutuling element 58 having one end coupled to the post device 52 is used to attach the soft tissue, generally de~ign~ted 56, to the post device 52. The suturing element 58 may be 5 coupled to the post device 52 by tying or wrapping the suturing element around the leg portion below the enlarged end 53. Alternatively, post device 52 may be integrally or monolithically formed with the suturing element 58 as shown in Figure 10 or the post 52 may be formed with ring 60 to which suturing element 58 may be attached as is shown in Figure 11. In the modification shown in Figure 12, post device 52 anchors a surgical plate 62 to the bone and the 10 suturing element 58 is secured to the surgical plate 62. In the modification shown in Figure 11, the suturing element is passed through aperture 64 and tied to the plate 62. It will be understood that other means in accordance with the invention may also be employed to affix the suturing element to the surgical plate or the post. Although not shown, the post device may be inserted through an aperture formed in the suturing plate or other similar surgical member as a tack. The 15 opposite end ofthe suturing element may be attached to the soft tissue 56, as shown in Figure 9.
Alternatively, the opposite end of the suturing element may be secured to a second f~tçning element, with the soft tissue being supported by the loop of the suturing element between the secured ends. The post device and suturing element of the present invention secure the soft tissue to the post device and holding the tissue in the desired position by essentially suspending the 20 tissue from the anchored post device. By adjusting the length of the suturing element and the position ofthe post device, bone fixation apparatus ~0 may be conveniently employed to hold the soft tissue in the desired position during the healing process.
As is app~t;lll from the foregoing description, the bone fixation appa~ s of the present invention is particularly suitable for holding bone sections or soft tissue in the desired position.
25 The post devices anchor the surgical member, such as the surgical plate or suturing element, to bone without securely eng;lging the bone and attaching the surgical member to the bone surface.
Wlth the present invention, the size of the post device may be minimi7:ed. For example, the post device may have a leg diameter on the order of about 1 mm. The bone fixation apparatus of the ~ 7 present invention may be formed of any suitable bic-compatible or absorbable materials.
Examples of suitable materials include, but are not limited to, bio-compatible metals, bio-co"lp~l,l,le ela~lo,l-el~ e~ biling sufficient stiffiless properties and other bio-compatible polymers, and bio-absorbable polymers which are partially or completely absorbed by the body after time S may also be used.
Brief Description of the Invention This invention relates in general to a surgical bone fixation apparatus and, more particularly, to an apl)a~ s for the fixation of bone and soft tissue to bone.
Background Qf the Invention Various surgical plates have been employed in the treatment of traumas to facial or cranial bone structure, plastic surgery, reconstructive facial surgery, and the like to hold the bone sections or fragments in place during the healing process. The surgical plates are positioned against the surface of the bone sections which must be held together and fixed to the bone by 10 mP~h~nical r~Le~ such as bone screws, wire sutures or other fasteners which secure the plate to the bone surface. The fasteners are securely pressed or embedded in the bone to prevent the surgical plates from being pulled away from the surface of the bone sections. U.S. Patents 4966,599 and 5,290,281 disclose examples of bone stabilization plates which are secured to the bone structure, for example facial or cranial bones, by bone screws. U.S. Patent 4,655,203 15 discloses a surgical device for immobilization of bone fracture which includes a stiffplate and stiff fixing elements which may be pressed into notches formed in the bone.
In such procedures as rotator cuff surgery and hand tendon surgery, tendons or other soft tissues are fixedly secured to bone. The tendons or other tissue are o~cen secured to bone by feeding the soft tissue through holes formed in the bone and suturing the tissue in place. Another 20 method of securing soft tissue to bone employs a fixation device which essentially tacks the tendon to bone. Unless the tendon or other soft tissue is completely irnmobilized, the fixation device must be securely embedded in the bone to hold the tendon stationary against the bone surface, resisting those forces tending to pull the tendon away from the bone surface, until the tendon has become attached to the bone. Another method of securing tendons and other soft tissue to bone uses a fixation device with an ~t~ched suture. Once again, the fixation device must be securely embedded in bone to resist forces tending to pull the tissue away from the bone surface. In various facial surgery procedures, soft tissue is surgically lifted or moved and then secured to bone by suturing and the like to hold the tissue in the desired position during the S healing process. These tissues are generally subjected only to gravitational forces or other forces parallel to the surface of the bone, they are not exposed to forces tending to pull the tissue outwardly away from the bone.
Surgical plates must be securely affixed to bones which may be exposed to various tensile and bending forces during the healing process to prevent the plate from being pulled outwardly 10 away from the bone. If the fasteners do not securely engage the bone, the applied stresses may have a tendency to pull the fasteners from the bone. Facial and cranial bone sections, on the other hand, are genel~lly not exposed to such tensile and bending stresses. Tn~te~ the bone sections are primarily subjected to forces tending to spread the bone sections apart or to cause lateral slippage of the bone sections along the fracture line. Since the applied forces are subst~nti~lly 15 parallel to the bone surface, the fasteners need only anchor the surgical plates to the facial or cranial bones to hold the bone sections in place. The additional security provided by securely embedding the f.q.stener in bone and actually securing the plate to the bone surface is often not required with facial and cranial bones and of bones at other sites.
Securely embedding screws, nails and the like in bone is a time con~uming and labor 20 intensive process, considerably extending the time required to complete the operation. Even when the fasteners are initially inserted into pre-drilled holes, care must be taken to ensure that the desired o~ ;on ofthe fasteners is /~ e~l Moreover, embedding the fasteners in bone may subject the relatively fragile facial bones to additional unnecessary stress. Surgical fasteners such as screws and the like require expensive m~nllf~cturing techniques because ofthe small size 25 of the fastener. Mi~ g the size of the plate and fastener would ...il~ -i,e the size of the surgical area and the amount of bone which must be exposed. However, the reduced size of the screws and other Ç~lellel~ is limited because the fasteners have sufflcient strength to engage bone and securely attach the plate to the bone. Using a fixation device which anchors the surgical plate ~ 2 ~ 7 to the bone, but does not securely affix the plate to the bone surface, would avoid the disadvantages ~soçi?~ed with embedding the fastener in bone. Such a fixation device would also be particularly useful in other types of procedures where the fixation ~pa~ s may be employed to afflx soft tissue to bone.
The surgical plates and associated fasteners employed for bone fixation have been fabricated of materials such as titanium, stainless steel, vitalium, chrome cobalt, and suitable bio-co,l,l,alible polymeric materials. Unless removed by surgery, the plates and fasteners formed of these materials permanently remain in the patient's body. The surgical plates and internal f~tening IllClllbt;l:i may cause various unpredictable problems if left intact as the bone dynamically reacts to the foreign bodies over time by molding to the shape of the foreign body, forming deposits on the foreign body, and responding to stress. The foreign bodies also provide potential cites for infection. Migration of the foreign body presents another problem if the surgical plate and/or f~tçners are left in the patient's body. This problem is of particular concern when the patient is an infant or young child, where the considerable amount of skull growth has resulted in significant migration offoreign body to the extent where the plate has entered the brain.
Forming the plate and/or r~lei,e,~ of a material which may be absorbed by the body over time would aUow the foreign materials to be removed from the patient's body without requiring a second operation. U.S. Patents 5,655,203,4,905,680, 4,966,599,5,275,601 and 5,290,281 describe rulll~ing ~e surgical plates and/or fasteners of absorbable materials. Fabricating a bone screw or other tner.h~nical fastener out of absorbable polymers is often difficult because the absorbable fastener has a tendency to prematurely slip from the bone. Moreover, because of their reduced size, forming absoll,ablc bone screws for the fixation of plates to facial and cranial bones is even more difficult. To achieve the desired strength, the absorbable screws must be larger in size than a colll~le metal screw. A fixation device for the fixation of surgical plates to bone which may be easily m~m ~f~ct Ired of an absorbable material and reliably used is highly desirable.
Objects and Summary of the Invention It is a primary object ofthis invention to provide a bone fixation apparatus for the surgical fixation of bone or soft tissue to bone.
r -It is another object of this invention to provide a bone fixation appa~ ls for anchoring a surgical plate, suturing element or other surgical member to bone.
It is yet another object ofthis invention to provide a bone fixation al)pal~Lus which may be quickly and easily applied to bone by the surgeon without subjecting the bone to unnecessary 5 stresses.
It is stil~ another object ofthis invention to provide a bone fixation a~pal~ s in which the size ofthe post fixation device may be l~ ed It is a further object of this invention to provide a bone fixation appal al~ls which may be fabricated of materials which are absorbed by the body over time.
A more general object ofthis invention is to provide a bone fixation apparatus which may be economically m~mlf~ctl-red and which may be efficiently and reliably employed in the fixation of surgical plates, suturing elements and other surgical members to bone.
In summa~y, this invention provides a bone fixation apparatus which is particularly suitable for use in the fixation of bone and/or soft tissue to bone. In one modification of the invention, 15 the bone fixation appa.~ s generally includes at least one post device having a leg portion configured for re1easable insertion into a hole formed in bone. The leg portion is of sufflcient length relative to the interior (1i~meter of the hole to resist removal of the leg portion from the hole in the bone when forces substantially parallel to the outer surface of the bone are applied to the post device. The post device anchors a surgical member, such as a surgical plate or suturing 20 element, to bone. In another modification of the invention, the bone fixation device includes a continuous, elongated sheet of surgical plate material which is divisible into a plurality of plate members each having an albiL,~y length. The plate members are mountable to the bone by f~tening devices such as the post device.
Additional objects and features of the invention will be more readily apparenl from the 25 following detailed description and appended claims when taken in conjunction with the drawings.
Brief Description of the Drawin~s Figure 1 is an e~ ,ed, fragmentary, cross sectional view of a bone fixation apparatus in accordance with this invention, shown fixed to two bone sections.
Figure lA is an enlarged, fragmentary view of a modified post device.
Figure 2 is an enlarged, fragmentary, top plan view of the bone fixation appaldl-ls and bone sections of Figure 1.
Figure 3 is an enlargéd, fr~ment~ry, top plan view of a bone fixation appa~allls in S accordance with another embodiment of the invention.
Figure 4 is an enlarged, fragmentary, top plan view of a bone fixation appdldllls in accordance with yet another embodiment of the invention.
Figure 5 is a fr~nçnt~ry, cross sectional view taken along line 5-5 of Fig 4.
Figures 6 and 6A are schematic, top plan views of a bone fixation a~ aldlus in accordance with another embodiment of the invention.
Figure 7 is an enlarged, side elevational view of a bone fixation apparatus in accordance with another e~ ent of the invention.
Figure 8 ~s an enlarged, side elevational view of the bone fixation a~pa~ s of Figure 7, shown during ~p~l;G~ n of the apparatus to the bone sections.
Figures 9 is a schematic, fi~ . y, side elevational view of a bone fixation appaldLus in accold~lce with another embodiment of the invention, shown securing soft tissue to bone.
Figures 1~12 are fra~rnent~ry, side elevational views of other modifications of the bone fixation app~dlus shown in Figure 9.
Detailed Description of the Invention R~rt;l~ncewill now be made in detail to the preferred embodiment of the invention, which is illustrated in the accoml)~lying figures. Turning now to the drawings, wherein like components are de~iig~.~led bylike reference numbers throughout the various figures, attention is directed to Figures 1 and 2.
A bone fixation apparatus 10 incorporating this invention may be used for the fixation of bone or soft tissue to bone. In the modification of Figures 1 and 2, the bone fixation apparatus 10 is shown holding two bone sections 6 and 7 in a desired position about a fracture line or incision, generally design~ted 8. Fixation apparatus 10 may be used with any type of bone structure as for example cancellous bones with marrow 9, bones without marrow such as the walls ofthe sinus, and the skull which includes an outer table, an inner table and marrow between the inner and outer tables. Preferably, the fixation apparatus 10 of the invention is used with bones which are subjected primarily to forces parallel to the bone surface, such as those which tend to sepa ~l~ the bone sections or cause relative lateral movement of the bone sections. The bones are generally isolated from forces transverse to the bone surface and are not required to carry a significant load. Examples of such bones include the facial and cranial bones, although it will be understood that use ofthe bone fixation apparatus may also be used with other suitable bones.
In the embodiment shown in Figure 1, bone fixation apparatus 10 includes a surgical plate member 12 extending across the surface of the bone and post devices 14 ret~inin~; plate member 12 in place. The shape, size and thickness of plate member 12 is subject to considerable modification depending upon the location of bone sections 6 and 7, the size of fracture line 8, the characteristics ofthe material of plate member 12, the characteristics and desired result of the surgical procedure employing the appa~ s and the like. Surgical plate member 12 is anchored 1~ to each bone section by at least one post device 14. In many applications, using one post device 14 per bone section as shown in Figures 1 and 2 will sufficiently retain the bone sections in the desired position. However, using more than one post device for at least one of the bone sections offers the advantage of increased stability and augmented parallelographic force. For example, Figure 3 shows a modification ofthe invention where one post device 14a anchors plate member 12 to bone section 6 and two post devices 14b and 14c anchor the plate to bone section 7. The positioning of post devices 14a, 14b and 14c creates a tri~n~ll~tion effect which substantially resists relative lateral movement of the bone sections along the fracture line. Instead of using three post devices 14 for enhanced stability as shown in Figure 3, a greater number of post devices 14 may be employed if desired.
Eadditional security is desired~ plate member 12 may be secured to bone by replacing one ofthe post devices 14, for example post device 14a shown in Figure 3, with a screw or other suitable fastener which securely engages the walls of hole 24 to attach the plate member to the surface of the bone section. The rem~ining post devices, such as post devices 14b and 14c, ~ 7 anchor the plate member 12 to the other bone section to retain the bone sections in the desired position.
As shown in Figure 1, post device 14 includes an enlarged cap or end portion 16 and a leg portion 18 depending from the underside 20 of end portion 16. The leg portion 18 extends S through an aperture 22 formed in plate member 12 and is positioned in a hole 24 formed in bone sections 6 and 7 to anchor surgical plate 12 to the bone sections. Unlike the fixation devices of the prior art, post device 14 is not intended to prevent the surgical plate 12 fiom being pulled away from the surf~ce ofthe bone sections. Instead, post device 14 substantially resists forces parallel to the surface of the bone, such as those tending to separate the bone sections or cause 10 lateral slippage along the fracture line, to hold surgical plate 12 in place. Leg portion 18 is formed of sufflcient length relative to the interior diameter of the hole 24 to resist those forces parallel to the bone surface. The optimum length for leg portion 18 depends in part on such factors as the stif~ess ofthe material used in the fabrication of post device 14 and the m~gnitucle of the forces applied to the post device. For many applications, a length of at least about two 15 times the interior rli~meter of the hole 24 will be suff~cient to prevent forces parallel to the bone surface from deforming the leg portion and pulling the leg portion 18 from the bone. However, it will be l-n~l~rs~ood that in some applications of the invention it may be desirable to provide leg portion 18 with a lesser or greater length or angle.
Since it is the length ofthe leg portion 18 which holds the post device 14 in the hole and 20 anchors the plate member 12 to the bone sections~ leg portion 18 may be shaped so that only a minimllm amount of pressure is required to slip the leg portion into the hole 24. The leg portion 18 is not securely embedded in place, but is instead movable in a direction parallel to the axis of the hole. The exterior of leg portion 18 may be substantially cylindrical as shown in Figure 1, or, if desired, leg portion 18 may be configured to provide a limited area of engagement between the 25 exterior ofthe leg portion and the walls of hole 24. For example, Figure lA shows a modification of post device 14 having a slightly bowed or spindle-shaped cross section, although it is to be understood that leg portion 18 may have other cross sectional shapes if desired. Moreover, the area of limited enga~ement need not extend around the entire circumference of the leg portion 1~. Tn~te~tl, leg portion 18 may be formed with one or more projections which are configured to slightly engage the interior wall of hole 24.
The m~iml-m ~ .,.ete~- ofthe spindle-shaped leg portion shown in Figure lA is preferably equal to or slightly greater than the interior diameter of the hole 24 so that when the post device 5 14 is initially inserted in the hole, the leg portion will partially engage the wall of the hole.
Although the limited engagement between the leg portion and wall of the bone is generally insufflcient to securely retain the post in the hole 24, the spindle shape of leg portion 18 allows the surgeon to conveniently manipulate the surgical plate relative to the bone sections during the surgical procedure without pulling the post device from the hole 24. Since only a limited area of 10 leg portion 18 engages the walls of the bone, the pressure required to insert the post device 14 into hole 24 is not significantly increased.
As is shown particularly in Figure 1, leg portion 18 is preferably oriented at an angle of about 15 to 55 degrees relative to the underside 20 of the end portion 16. For optimum effectiveness, the angled leg portion 18 is inserted into a hole 24 e~ct~.n-ling into the bone at 15 app-ox;. ~ l~lr3y the same angle as the inclin~tion of leg portion 18 so that the underside 20 of the end portion engages the upper surface of the plate member 12. Aperture 22 may also extend through plate ,llt;"d~er 12 at an angle. When post device 14 is inserted in the bone, the angled leg portion 18 is ~lert;l~bly oriented so that the tip of the leg portion points in a direction opposite the forces applied to the bone section. For example, in Figure 1 the angled leg portion 18 is 20 oriented illw~udly toward the fracture line, extending in a direction opposite those forces tending to pull the bone sections 6 and 7 apart.
Providing post device 14 with a slanted leg portion increases the stability of bone fixation apparatus 10 in resisting forces parallel to the bone sections 6 and 7. When positioned as shown in Figure 1, the slanted leg portions of the post devices 14 on opposite sides of the fracture line 25 may also be used to urge the bone sections 6 and 7 together. Urging the bone sections together with post devices 14 ensures the bone sections are held together, f~çilit~ting the healing process.
Although angled leg portions 18 increase the ability of post device 14 to resist forces substantially ~ 7 parallel to the bone sections, it will be understood that the leg portions 18 may also be perpendicular to the underside of end portion 16 if desired.
The bone ffxation apparatus 10 may be applied to the selected bone sections using a suitable surgical technique. Apertures 22 may be forrned in plate member 12 at predetermined locations or, if desired, the surgeon may select the site of the apertures. If desired, the apertures 22 and holes 24 may be formed simultaneously by locating the plate member 12 on the bone sections 6 and 7 and drilling through the plate and bone. However, rO~ g the apertures 22 separately from the holes 24 isolates the wound or surgical site from unwanted surgical plate fragments. The locations of holes 24 may be selected using a template if desired. Preferably, 10 holes 24 are formed using a drill or other appropriate instrument having a stop or collar limiting the hole depth to avoid excess penetration particularly in the skull. When post devices 14 having angled leg portions 18 are employed, the stop is pl erel ably oriented at an angle relative to the drill bit similar to the angle between the end portion 16 and leg portion 18. Alternatively, the stop may be curved for usage with post devices angled or perpendicular to the end portion 16.
The configuration of surgical plate member 12 is subject to considerable variation depending upon the con~t,~;"ls of a particular application. Figure 2 shows a plate member 12 having a s~ ally rect~n~ r shape. The plate member may also have other shapes such as the tri~n~ r shape shown in Figure 3. Figures 4 and 5 show another embodiment of the invention in whicirplate member 12 includes a flange or rib 30 depending from the underside 31 20 of the plate member 12. In the embodiment shown in Figures 4 and 5, the flange 30 extends contimlously along the entire length ofthe plate member. However, flange member 30 may have other configurations if desired. Flange 30 is positioned in a thin groove or cut 32 forrned in the bone to assist in obl~;n-llg the desired positioning of bone fixation appalalus 10 and bone sections 6 and 7 when the apparatus 10 is initially anchored to the bone. The inter-~n~g~ment of flange 25 30 and groove 32 also provides additional resistance against relative lateral slippage between the bone sections 6 and 7. In the modification shown in Figures 4 and 5, four post devices 14 having a spindle-shaped cross section are employed to anchor plate member 12 to bone. The post devices 14 may have slanted leg portions or leg portions subst~nti~lly perpendicular to the plate member 12.
Although not shown, the plate member may also be formed with a curved or steppedcross-section. The curved or stepped configuration may be prefabricated or the plate member 5 may be formed of a suitable material and manipulated into the desired shape by the surgeon or surgical ~x~ The prefabricated plate member may also be formed of a m~t~ l which allows the shape ofthe plate member to be adjusted during the operation.
Figure 6 illustrates a modification of the invention in which plate member 12 comprises a section of an elongated sheet 36 of surgical plate material. The sheet 36 shown in Figure 6 is 10 of sufficient width to allow the surgeon select any shape desired for the surgical plate.
Alternatively, as is shown in Figure 6A the sheet 36 may be formed as a narrow strip of material which may be s~alaled into plate sections of arbitrary lengths. The ability to divide the sheet 36 of plate material into plate sections each having an arbitrary shape provides the surgeon with immediate access to a plate member 12 of appropriate size. The sheet 36 of surgical plate 15 material may be divided into separate plate sections using the appropliate clipping tools for the particular material of sheet 36. Dependillg upon the material employed for surgical sheet 36, the sheet 36 may be retained in a roll or provided as a planar sheet of material. As with the previously described embotlim~nt~, apertures may be pre-formed in sheet 36 or the apertures may be formed by the surgeon at the desired locations. Alternatively, as will be described in greater 20 detail in relation to Figures 7 and 8, sheet 36 may be integrally formed with a plurality of spaced post devices 14.
Turning to Figures 7 and 8, bone fixation device 10 is a monolithic structure in which post devices 14 are integrally formed with plate member 12. In the modification shown in Figures 7 and 8, the leg portions 18 ofthe post devices 14 are oriented at an angle relative to the underside 25 of plate member 12. The fixation appa~ s is applied to bone by d~;roll-l-ng the edges of plate member 12 upwardly as shown in Figure 8 to position the tips 40 ofthe post device above the open ends of the holes 24. Preferably, the upper surface of the plate 12 is concave to f~cilit~te d~rolm~ion ofthe plate to bring the post devices 14 into a substantially parallel orientation. The post devices 14 are then slipped into the holes and the plate member 12 is moved toward the bone surface. The plate member 12 returns to its original shape shown in Figure 7, with the angled post devices 14 providing addition resistance against separation, when the outer edges of the plate member are released and the plate member is positioned against the bone surface. Preferably, a 5 surgicat instrument 41 is used to bend the plate 14 and hold the plate as shown in Figure 8, allowing a nurse or surg,ical te~' ~iciqn to prepare the plate for insertion and allowing the surgeon to manipulate the plate to the desired position. The surgical instrument may also be used to adjust the position of the fixation apparatus or to remove the fixation appal~LIls from the bone.
The post devices 14 anchor the fixation apparatus to bone to retain the bone sections in 10 the desired position during healing. As previously described, the angled leg portions 18 provide increased rç~ict~n~e to oppose forces substantially parallel to the bone surface and retain the bone sections in place. In the present embodiment, the post devices are preferably oriented at an angle of appro~imately 10-20 degrees to ...;~ e the amount of derolllla~ion of plate 12 which is required to insert the post devices 14 into holes 40.
Although slanted leg portions 18 are preferred for increased stability, post devices 14 may also extend in a direction substantially perpendicular to the underside of the plate member 12.
Wlth the pel~ r post devices 14, upward deformation may not be required to ali~,n the tips 40 of the post devices with the holes 24 formed in the bone sections.
In the previously described embodiments ofthe invention, bone fixation appalalus 10 was 20 particularly suitable for the fixation of bone to bone. Figures 9-1 1 show alternative embodiments of the invention where bone fixation apparatus 10 is employed to affix or anchor soft tissue to bone. Turning to Figure 9, bone fixation device 50 includes a post device 52 having an enlarged end portion 53 and a leg portion ~4 which may be slipped into a hole 55 forrned in bone. The leg portion 54 of the post device 52 is of sufficient length to substantially resist forces substantially 25 parallel to the surface ofthe bone, providing an anchor for securing soft tissue to bone. As with the embodiments of Figures 1-8, leg portion 54 is preferably formed so that it slips into hole 55 with minimal force. If desired, the leg portion 54 be shaped to provide a limited area of ~ 7 -engagement with the walls of the hole 55 to allow the surgeon to conveniently manipulate the bone fixation appa~ s 50 without pulling leg portion 54 from hole 55.
A sutuling element 58 having one end coupled to the post device 52 is used to attach the soft tissue, generally de~ign~ted 56, to the post device 52. The suturing element 58 may be 5 coupled to the post device 52 by tying or wrapping the suturing element around the leg portion below the enlarged end 53. Alternatively, post device 52 may be integrally or monolithically formed with the suturing element 58 as shown in Figure 10 or the post 52 may be formed with ring 60 to which suturing element 58 may be attached as is shown in Figure 11. In the modification shown in Figure 12, post device 52 anchors a surgical plate 62 to the bone and the 10 suturing element 58 is secured to the surgical plate 62. In the modification shown in Figure 11, the suturing element is passed through aperture 64 and tied to the plate 62. It will be understood that other means in accordance with the invention may also be employed to affix the suturing element to the surgical plate or the post. Although not shown, the post device may be inserted through an aperture formed in the suturing plate or other similar surgical member as a tack. The 15 opposite end ofthe suturing element may be attached to the soft tissue 56, as shown in Figure 9.
Alternatively, the opposite end of the suturing element may be secured to a second f~tçning element, with the soft tissue being supported by the loop of the suturing element between the secured ends. The post device and suturing element of the present invention secure the soft tissue to the post device and holding the tissue in the desired position by essentially suspending the 20 tissue from the anchored post device. By adjusting the length of the suturing element and the position ofthe post device, bone fixation apparatus ~0 may be conveniently employed to hold the soft tissue in the desired position during the healing process.
As is app~t;lll from the foregoing description, the bone fixation appa~ s of the present invention is particularly suitable for holding bone sections or soft tissue in the desired position.
25 The post devices anchor the surgical member, such as the surgical plate or suturing element, to bone without securely eng;lging the bone and attaching the surgical member to the bone surface.
Wlth the present invention, the size of the post device may be minimi7:ed. For example, the post device may have a leg diameter on the order of about 1 mm. The bone fixation apparatus of the ~ 7 present invention may be formed of any suitable bic-compatible or absorbable materials.
Examples of suitable materials include, but are not limited to, bio-compatible metals, bio-co"lp~l,l,le ela~lo,l-el~ e~ biling sufficient stiffiless properties and other bio-compatible polymers, and bio-absorbable polymers which are partially or completely absorbed by the body after time S may also be used.
Claims (22)
1. A method of retaining adjacent bone sections in a desired position during the healing process comprising the steps of:
providing a bone fixation apparatus having a plate member configured to extend across a portion of each of said bone sections and a plurality of said post devices carried by said plate member, each of said post devices having an elongate leg portion with a cylindrical surface having an outer diameter, forming at least one hole in each of said bone sections, said hole having an inner diameter, slipping said leg portion of each of said post devices into one of said holes to mount said plate member to said bone sections, said leg portion being slidable within said hole in a direction parallel to the longitudinal axis of said hole for substantially unrestrained movement of said leg portion into and out of said hole, said leg portion having a length relative to said inner diameter of said hole to resist removal of said leg portion from said hole when forces having an orientation substantially parallel to the outer surface of said bone sections and at an angle relative to the longitudinal axis of said hole are applied to said post devices so that said post devices anchor said plate member to said bone sections and retain said bone sections in said desired position during said healing process.
providing a bone fixation apparatus having a plate member configured to extend across a portion of each of said bone sections and a plurality of said post devices carried by said plate member, each of said post devices having an elongate leg portion with a cylindrical surface having an outer diameter, forming at least one hole in each of said bone sections, said hole having an inner diameter, slipping said leg portion of each of said post devices into one of said holes to mount said plate member to said bone sections, said leg portion being slidable within said hole in a direction parallel to the longitudinal axis of said hole for substantially unrestrained movement of said leg portion into and out of said hole, said leg portion having a length relative to said inner diameter of said hole to resist removal of said leg portion from said hole when forces having an orientation substantially parallel to the outer surface of said bone sections and at an angle relative to the longitudinal axis of said hole are applied to said post devices so that said post devices anchor said plate member to said bone sections and retain said bone sections in said desired position during said healing process.
2. The method of Claim 1 in which said providing step includes providing a resilient plate member, and further comprising the step of resiliently deforming said plate member to substantially align the tips of each of said leg portions with one of said holes.
3. The method of Claim 1 in which said providing step includes providing a post device having an enlarged portion projecting from said cylindrical surface, said enlarged portion defining a maximum diameter of said leg portion, and in which said forming step includes forming said hole with an inner diameter no greater than said maximum diameter so that said enlarged portion defines a limited contact area where said leg portion forms a tight fit with the inner wall of said hole to partially restrain sliding movement of said leg portion within said hole during manual manipulation of said plate member relative to said bone sections.
4. The method of Claim 1 in which said providing step includes providing a continuous, elongated sheet of surgical plate material, and further comprising the steps of determining the configuration of said adjacent bone sections and cutting a plate member from said elongated sheet of surgical plate material having a desired shape for covering said portion of each of said bone sections.
A bone fixation apparatus for anchoring a surgical member to bone having an outer surface and at least one hole formed therein having interior diameter, said bone fixation apparatus comprising:
at least one post device having a leg portion configured for slidable insertion into said hole, said leg portion being of sufficient length relative to said interior diameter of said hole to resist removal of said leg portion from said hole when forces substantially parallel to said outer surface of said bone are applied to said post device to anchor said surgical member to said bone.
at least one post device having a leg portion configured for slidable insertion into said hole, said leg portion being of sufficient length relative to said interior diameter of said hole to resist removal of said leg portion from said hole when forces substantially parallel to said outer surface of said bone are applied to said post device to anchor said surgical member to said bone.
6. The bone fixation apparatus of Claim 1 in which said leg portion has an enlarged portion having a maximum diameter greater than said interior diameter of said hole, said enlarged portion being shaped to engage said bone when said leg portion is inserted in said hole.
7. The bone fixation apparatus of Claim 1 in which said post device has an enlarged end portion opposite said leg portion having a maximum width greater than said first diameter of said hole.
8. The bone fixation apparatus of Claim 7 in which said enlarged end of said post device has a mating surface configured to engage a portion of said bone around said hole and in which the longitudinal axis of said leg portion is oriented at an angle of about 15 to 55degrees relative to said mating surface.
9. The bone fixation apparatus of Claim 1 in which said leg portion has a diameter of about 1 mm.
10. The bone fixation apparatus of Claim 1 in which said post device has a ring-shaped end portion opposite said leg portion, said end portion defining an aperture configured for securement of said surgical member to said post device.
11. The bone fixation apparatus of Claim 1 in which said leg portion has a length of at least about two times said interior diameter of said hole.
12. The bone fixation apparatus of Claim 1 in which said post device is formed of an absorbable material.
13 . A bone fixation apparatus for retaining adjacent bone sections in a desired position during the healing process, said bone sections each having an outer surface and at least one hole formed therein, said hole having an interior diameter, said bone fixation apparatus comprising:
a plate member configured to extend across a portion of each of said bone sections, said plate member having an upper surface and a lower surface positionable on said outer surface of said bone sections, and at least one post device carried by said plate member for each of said bone sections, each said post device having a leg portion configured for slidable insertion into said hole, said leg portion being of sufficient length relative to said interior diameter of said hole to resist removal of said leg portion from said hole when forces substantially parallel to said outer surface of said bone sections are applied to said post device to anchor said plate member to said bone sections and retain said bone sections in said desired position.
a plate member configured to extend across a portion of each of said bone sections, said plate member having an upper surface and a lower surface positionable on said outer surface of said bone sections, and at least one post device carried by said plate member for each of said bone sections, each said post device having a leg portion configured for slidable insertion into said hole, said leg portion being of sufficient length relative to said interior diameter of said hole to resist removal of said leg portion from said hole when forces substantially parallel to said outer surface of said bone sections are applied to said post device to anchor said plate member to said bone sections and retain said bone sections in said desired position.
14. The bone fixation apparatus of Claim 13 in which said leg portion has an enlarged portion having a maximum diameter greater than said interior diameter of said hole, said enlarged portion being shaped to engage said bone when said leg portion is inserted in said hole.
15. The bone fixation apparatus of Claim 13 in which said plate member has a plurality of apertures formed therein, each said post device being positioned in one of said apertures with said leg portion of said post device depending from said lower surface of said plate member.
16. The bone fixation apparatus of Claim 16 in which said post device includes an enlarged end portion shaped to engage a portion of said upper surface of said plate member adjacent said one of said apertures.
17. The bone fixation apparatus of Claim 13 in which said leg portion of said post device is inclined at an angle of about 15 to 55 degrees relative to said lower surface of said plate member.
18. The bone fixation apparatus of Claim 17 in which said plate member is resiliently deformable between a first position with said leg portion of each said post device positioned for insertion of said leg portion into said hole and a second position with said leg portion positioned to bias said bone sections together when said leg portion is positioned in said hole.
19. In combination, the bone fixation apparatus of Claim 18 and an instrument engaging said plate member and retaining said plate member in said first position.
20. The bone fixation apparatus of Claim 13 in which said plate member includes a downward depending flange formed on said lower surface thereof, said flange being insertable in a groove formed in at least one of said bone sections.
21. The bone fixation apparatus of Claim 13, and further comprising a fastener mountable to said plate member and one of said bone sections to secure said plate member to said one of said bone sections, said fastener having a longitudinal axis, said fastener being configured to substantially resist removal of said fastener from said bone upon application of a force substantially parallel to said longitudinal axis.
22. The bone fixation apparatus of Claim 13 in which at least one of said plate member and said post device are formed of an absorbable material.
Priority Applications (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/428,913 US5634926A (en) | 1995-04-25 | 1995-04-25 | Surgical bone fixation apparatus |
| CA002201087A CA2201087A1 (en) | 1995-04-25 | 1997-03-26 | Surgical bone fixation apparatus |
| AU16656/97A AU1665697A (en) | 1995-04-25 | 1997-04-02 | Surgical bone fixation apparatus |
| US08/852,012 US5785713A (en) | 1995-04-25 | 1997-05-06 | Surgical fixation apparatus |
| JP9117818A JPH10314182A (en) | 1995-04-25 | 1997-05-08 | Surgical bone fixing device |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/428,913 US5634926A (en) | 1995-04-25 | 1995-04-25 | Surgical bone fixation apparatus |
| CA002201087A CA2201087A1 (en) | 1995-04-25 | 1997-03-26 | Surgical bone fixation apparatus |
| EP97302163A EP0867149B1 (en) | 1995-04-25 | 1997-03-27 | Surgical bone fixation apparatus |
| AU16656/97A AU1665697A (en) | 1995-04-25 | 1997-04-02 | Surgical bone fixation apparatus |
| JP9117818A JPH10314182A (en) | 1995-04-25 | 1997-05-08 | Surgical bone fixing device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2201087A1 true CA2201087A1 (en) | 1998-09-26 |
Family
ID=27506620
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002201087A Abandoned CA2201087A1 (en) | 1995-04-25 | 1997-03-26 | Surgical bone fixation apparatus |
Country Status (4)
| Country | Link |
|---|---|
| US (2) | US5634926A (en) |
| JP (1) | JPH10314182A (en) |
| AU (1) | AU1665697A (en) |
| CA (1) | CA2201087A1 (en) |
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| US4960420A (en) * | 1988-08-23 | 1990-10-02 | Marlowe Goble E | Channel ligament clamp and system |
| US5053038A (en) * | 1989-08-17 | 1991-10-01 | Tenstaple, Inc. | Compression bone staple |
| US5129906A (en) * | 1989-09-08 | 1992-07-14 | Linvatec Corporation | Bioabsorbable tack for joining bodily tissue and in vivo method and apparatus for deploying same |
| US5037422A (en) * | 1990-07-02 | 1991-08-06 | Acufex Microsurgical, Inc. | Bone anchor and method of anchoring a suture to a bone |
| DE4110123A1 (en) * | 1991-03-27 | 1992-10-01 | Augustin Dr Betz | ELASTIC CLAMP |
| DE4111856C1 (en) * | 1991-04-11 | 1992-07-16 | Oswald Leibinger Gmbh, 7202 Muehlheim, De | |
| US5275601A (en) * | 1991-09-03 | 1994-01-04 | Synthes (U.S.A) | Self-locking resorbable screws and plates for internal fixation of bone fractures and tendon-to-bone attachment |
| US5180381A (en) * | 1991-09-24 | 1993-01-19 | Aust Gilbert M | Anterior lumbar/cervical bicortical compression plate |
| US5139497A (en) * | 1991-11-25 | 1992-08-18 | Timesh, Inc. | Orbital repair implant |
| US5167665A (en) * | 1991-12-31 | 1992-12-01 | Mckinney William W | Method of attaching objects to bone |
| US5201736A (en) * | 1992-01-13 | 1993-04-13 | Strauss Sorrell I | Maxillofacial bone clamp |
| NL9201974A (en) * | 1992-06-11 | 1994-01-03 | Lolke Johan Van Dijk | Attachment means for attaching an implant to bone tissue |
| EP0611567B1 (en) * | 1992-06-12 | 2002-08-28 | Teijin Limited | Ultrafine powder for inhalation and production thereof |
| US5290281A (en) * | 1992-06-15 | 1994-03-01 | Medicon Eg | Surgical system |
| US5370662A (en) * | 1993-06-23 | 1994-12-06 | Kevin R. Stone | Suture anchor assembly |
| US5522843A (en) * | 1994-02-23 | 1996-06-04 | Orthopaedic Biosystems Limited, Inc. | Apparatus for attaching soft tissue to bone |
-
1995
- 1995-04-25 US US08/428,913 patent/US5634926A/en not_active Expired - Fee Related
-
1997
- 1997-03-26 CA CA002201087A patent/CA2201087A1/en not_active Abandoned
- 1997-04-02 AU AU16656/97A patent/AU1665697A/en not_active Abandoned
- 1997-05-06 US US08/852,012 patent/US5785713A/en not_active Expired - Fee Related
- 1997-05-08 JP JP9117818A patent/JPH10314182A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JPH10314182A (en) | 1998-12-02 |
| AU1665697A (en) | 1998-10-08 |
| US5785713A (en) | 1998-07-28 |
| US5634926A (en) | 1997-06-03 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |