US20020164905A1 - Osteotomy guide and method - Google Patents
Osteotomy guide and method Download PDFInfo
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- US20020164905A1 US20020164905A1 US10/180,864 US18086402A US2002164905A1 US 20020164905 A1 US20020164905 A1 US 20020164905A1 US 18086402 A US18086402 A US 18086402A US 2002164905 A1 US2002164905 A1 US 2002164905A1
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- Prior art keywords
- osteotomy
- external fixation
- fixation device
- osteotomy guide
- bone
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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
- A61B17/14—Surgical saws ; Accessories therefor
- A61B17/15—Guides therefor
- A61B17/151—Guides therefor for corrective osteotomy
- A61B17/152—Guides therefor for corrective osteotomy for removing a wedge-shaped piece of bone
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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
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
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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
- A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
- A61B17/64—Devices extending alongside the bones to be positioned
- A61B17/6416—Devices extending alongside the bones to be positioned with non-continuous, e.g. hinged, pin-clamp connecting element
Definitions
- This invention relates in general to the field of medical devices and more particularly to an improved high tibial osteotomy method and apparatus.
- Procedures such as limb lengthening used to address congenital or traumatic conditions may include an orthopedic osteotomical procedure such as a high tibial osteotomy (HTO).
- HTO high tibial osteotomy
- an HTO procedure may be used to treat patients who suffer from a variety of ailments including varus or valgus deformities; that is, abnormal positions of a bone of the leg or foot.
- This procedure may be used to adjust cartilage wear patterns and/or the distribution of stress along the tibial and knee areas.
- Performing valgus or varus correction typically adjusts the angulation of a tibial bone and may, in many cases, delay or eliminate the need to replace a joint such as the knee.
- Proper adjustment of limb angulation desirably includes adjustment of the bone while the bone is healing.
- External stabilization or fixation devices are often used to compress and properly align an osteotomy during the healing process.
- Multiple bone screws, wires and/or pins are often used to provide compression or to attach an external fixation device which provides compression, prevents displacement of bone or tissue fragments, and supports the bone or tissue fragments during healing. These screws, wires and/or pins may be placed through one or both cortices of bone to properly position and align the osteotomy.
- Some conventional fixation devices may be used to adjustably secure a first bone portion above an osteotomy in a position relative to a second bone portion below the osteotomy.
- some of these devices may require physician intervention for adjustment, and/or may not allow functional use of the recovering limb while the limb is healing.
- these devices may impair a patient's ability to walk.
- many of these devices may impair a physician's ability to monitor the healing process and/or access the area surrounding the osteotomy.
- some conventional fixation devices may block or limit radiographic, ultrasonic and/or visual examination of a treatment site.
- some of these devices include a center of rotation that is generally aligned with a center of the tibia. These devices may require additional time for a separate distraction of the bone before the angulation adjustment process may begin, which may result in an extended treatment period. Moreover, these devices may in some cases be used to angulate a tibia with an osteotomy that is not aligned with an adjustment angle of the fixation device Such misalignment may not provide an optimal level of angulation and/or control thereof.
- the apparatus preferably includes a stabilizing portion adapted to be externally coupled to an anterior portion of a tibial bone.
- the apparatus may also include an angulation portion adapted to be externally coupled to another anterior portion of the tibial bone and coupled to the stabilizing portion.
- the angulation portion may be selectively adjustable to angulate a portion of the tibial bone about a center of rotation offset from a center of the tibial bone following an osteotomical procedure on the tibial bone.
- the osteotomy guide for placement of an osteotomy.
- the osteotomy guide has a generally rigid member adapted to be releasably coupled to an external fixation device.
- the osteotomy guide may also include a receptacle disposed in the member.
- the receptacle is preferably adapted to receive a plurality of instruments to be used in an osteotomical procedure on a tibial bone.
- the present invention provides several important advantages. Various embodiments of the invention may have none, some, or all of these advantages.
- the invention may permit a variety of monitoring activities.
- the invention includes a window that allows access and/or visual inspection of the osteotomy.
- the window may include materials that do not obstruct one or more imaging wavelengths.
- the window may include radiolucent material that is relatively transparent to x-rays.
- the invention may be secured to an anterior portion of a tibial bone, permitting functional use of the recovering limb while the limb is healing.
- the invention includes a center of rotation offset from a center of the tibial bone.
- Such an advantage may reduce or eliminate the need for a separate distraction period to avoid bone impingement before beginning the process of angulation adjustment.
- the invention may eliminate the need to wait for lengthening to be performed before angulation commences. That is, angulation may commence without waiting the approximately seven to ten days typically required for a separate lengthening or distraction period.
- the invention may also allow improved control over conventional methods.
- the invention allows a patient to perform incremental angulation adjustments. These incremental adjustments desirably promote angulation while reducing the risk of consolidation or solidification of the bone. Such an advantage also may reduce the overall treatment time and/or improve the control in angulation.
- the invention may also permit adjustments to be performed so that an osteotomy may be properly compressed.
- the invention also provides for flexibility in pin placement.
- the invention may also be used for treatment for both a patient's left and the right limbs.
- the invention may also provide guidance to a physician in performing an osteotomy.
- the invention may allow proper alignment of the osteotomy with a center of rotation. Such an advantage may improve the control and accuracy of the angulation adjustment process.
- FIG. 1 is a schematic drawing showing an isometric view of a high tibial osteotomy device incorporating teachings of the present invention
- FIG. 2 is a side view of a high tibial osteotomy device incorporating teachings of the present invention
- FIG. 3 is a schematic drawing showing another isometric view of a high tibial osteotomy device incorporating teachings of the present invention
- FIG. 4 is a schematic drawing showing an isometric view of a high tibial osteotomy device with an extended window incorporating the teachings of the present invention
- FIG. 5 is a schematic drawing illustrating a cross-sectional view of an adjustment portion of the high tibial osteotomy illustrated in FIG. 3;
- FIG. 6 is a schematic drawing showing an isometric view of an osteotomy guide incorporating teachings of the present invention
- FIG. 7 is a schematic drawing showing a front view of the osteotomy guide of FIG. 6;
- FIG. 8 is a schematic drawing illustrating a cross-sectional view of the osteotomy guide of FIG. 7;
- FIG. 9 is a schematic drawing showing an osteotomy guide that includes an insert
- FIG. 10 is a schematic drawing showing an osteotomy guide with an insert positioned in a slot.
- FIG. 11 is a schematic drawing showing a high tibial osteotomy device with an extended window incorporating an osteotomy guide with an insert.
- FIGS. 1 - 11 of the drawings like numerals being used for like and corresponding parts of the various drawings.
- HTO device 10 may be used in the performance and/or in the treatment of high tibial osteotomical procedures.
- HTO device 10 is operable to attach to an anterior portion of tibia 122 of a patient and, in some applications, a physician may perform the osteotomy after HTO device 10 is attached to tibia 122 .
- a physician may also use an osteotomy guide to perform the osteotomy.
- An osteotomy guide incorporating various features of the present invention is discussed in detail in conjunction with FIGS. 6 - 8 .
- HTO device 10 may be used to control the adjustment in angulation to tibia 122 about a center or axis of rotation offset from longitudinal axis or longitudinal centerline 142 of tibia 122 .
- FIG. 1 illustrates a tibia 122 that includes a generally transverse osteotomy 132 whose penetration through tibia 122 stops short of lateral cortex 124 .
- HTO device 10 may be attached to tibia 122 by means of stabilizing devices or pins 22 .
- HTO device 10 is disposed substantially externally to the body of the patient (not explicitly shown). Each pin 22 penetrates the body of the patient at a desired location and is connected to tibia 122 .
- HTO device 10 may be attached to tibia 122 to both stabilize osteotomy 132 and permit control of angulation of tibia 122 .
- HTO device 10 is operable to control angulation of a medial portion 126 of tibia 122 while callus tissue 128 forms therein.
- FIG. 1 is a schematic drawing showing an isometric view of a high tibial osteotomy device incorporating teachings of the present invention.
- HTO device 10 preferably includes an angulation portion 20 and a stabilizing portion 70 .
- Angulation portion 20 may be used in conjunction with stabilizing portion 70 to apply gradual correction angulation means to and control final limb alignment of tibia 122 .
- angulation portion 20 includes a proximally located first portion 24 , and at least one clamp mechanism 36 that is releasably coupled thereto.
- HTO device 10 is shown with an adjustment angle ⁇ of approximately zero degrees, where adjustment angle ⁇ is formed in an x-y plane formed by a y axis through hinge 28 and relative to an x axis through hinge 28 generally parallel to surface 29 of first portion 24 .
- HTO device 10 is operable to angulate tibia 122 about a center of rotation centered at hinge 28 that is offset from center 142 of tibia 122 .
- Angulation portion 20 also comprises an adjustment portion 40 that is operable to adjustably couple first portion 24 to distally located second portion 26 .
- Adjustment portion 40 may be selectively adjusted to increase or decrease adjustment angle ⁇ . This adjustment pivots about hinge 28 and results in expansion of medial portion 126 of tibia 122 .
- adjustment angle ⁇ may be selectively expanded by rotating hex socket 42 .
- Adjustment portion 40 is disposed on an exterior side of angulation portion 20 relative to the patient in this embodiment. The invention also contemplates an adjustment portion 40 disposed interiorly (relative to the patient) to angulation portion 20 .
- angulation portion 20 includes a second portion 26 that is hingedly coupled to first portion 24 by hinge 28 .
- Hinge 28 may be implemented using a variety of methods.
- hinge 28 may include a cylindrical pin 27 that rotatably couples cylindrically-shaped receptacles in both second portion 26 to first portion 24 .
- the present invention also contemplates the use of other hingeable, pivotable or rotatable means to couple second portion 26 to first portion 24 .
- First portion 24 , second portion 26 , and adjustment portion 40 form and enclose a window 60 .
- Window 60 provides an unobstructed view of tibial bone 122 that desirably allows examination of and/or access to osteotomy 132 .
- the physician and/or the patient may palpitate, visually inspect and/or monitor healing of the wound created by osteotomy 132 through window 60 .
- window 60 permits an unobstructed view of osteotomy 132 and callus portion 128 for a variety of examination and monitoring procedures. Such an advantage allows a variety of examination techniques to be used to observe the healing processes of osteotomy 132 and/or valgus and/or varus correction of bone 122 during treatment.
- procedures including, but not limited to, radiographic imaging (e.g., fluoroscopic, x-ray, magnetic resonance imaging, and computed tomography scanning techniques) and ultrasonic imaging may be used to capture unobstructed views of callus portion 128 at a variety of points during the healing process as tibial bone 122 is angulated.
- radiographic imaging e.g., fluoroscopic, x-ray, magnetic resonance imaging, and computed tomography scanning techniques
- ultrasonic imaging may be used to capture unobstructed views of callus portion 128 at a variety of points during the healing process as tibial bone 122 is angulated.
- stabilizing portion 70 includes a support member 71 that may be releasably coupled to second portion 26 as discussed in further detail in conjunction with FIGS. 2 and 3.
- second portion 26 and stabilizing portion 70 may include a single integrated member.
- Stabilizing portion 70 also includes clamp mechanisms 76 A and 76 B. Clamp mechanism 76 A may include one or more portions and may also be releasably coupled to support member 71 as discussed in conjunction with FIGS. 2 and 3.
- HTO device 10 may be anteriorly mounted on tibia 122 by means of at least four pins 22 as shown in the embodiment illustrated in FIG. 1. Two proximal pins 22 are located above osteotomy 132 , and two distal pins 22 are located below osteotomy 132 a distance D from proximal pins 22 .
- the present invention contemplates the use of more or fewer pins. For example, in some applications it may be desirable to utilize three distal pins 22 .
- the present invention also contemplates the use of other means of attaching HTO device 10 to tibia 122 .
- HTO device 10 may be connected to tibia 122 using stabilizing devices including, but not limited to, bone screws, wires, pins or a combination thereof. Pins 22 may be manufactured using any suitable implantable grade materials.
- stabilizing portion 70 includes at least one clamp mechanism operable to secure HTO device 10 to at least two distal pins 22 .
- stabilizing portion 70 includes clamp mechanisms 76 A and 76 B.
- Clamp mechanism 76 B may be releasably secured to clamp mechanism 76 A by adjusting cap screws 72 .
- a plurality of slots or receptacles 78 may be formed when clamp mechanism 76 A is coupled to clamp mechanism 76 B.
- Receptacles 78 may be generally linearly aligned as illustrated, staggered in other configurations, and/or be disposed in either or both clamp mechanisms 76 A and 76 B. Distal pins 22 may be releasably secured within at least two receptacles 78 .
- each clamp mechanism 36 may be selectively positioned in a slot or track 31 disposed in surface 29 .
- each clamp mechanism 36 may be translated along first portion 24 , and may be releasably fixed using cap screw 32 .
- the present invention also contemplates the use of a single slot 31 in which both clamp mechanisms 36 may be positioned, or other mechanisms for adjusting placement of proximal pins 22 .
- Each of these elements in angulation portion 20 may reside in a volume whose surface generally corresponds with a contour of a patient's lower leg. Such a configuration may be desirable in applications where placement of pins 22 may be selectively adjustable. Alignment and adjustment of distal pins 22 is discussed in conjunction with FIGS. 2 and 3.
- a physician may first align and then stabilize HTO device 10 with respect to tibia 122 by inserting one or more K-wires (not explicitly shown) through receptacles 11 into tibia 122 .
- the physician may also insert one or more K-wires through a receptacle in pin 27 into tibia 122 .
- the physician may then accurately position proximal screws 22 and then distal screws 22 .
- the physician may also releasably couple an osteotomy guide 200 to HTO device 10 .
- Osteotomy guide 200 may be used to assist the physician in performing the osteotomical procedure, and is discussed in further detail in conjunction with FIGS. 4 - 6 .
- FIG. 2 is a side view of a high tibial osteotomy device incorporating teachings of the present invention.
- osteotomy 132 is a medial osteotomy 132 on a right tibial bone 122
- FIG. 2 illustrates a medial view of HTO device 10 .
- first portion 24 is rotatably coupled to a generally u-shaped second portion 26 by hinge 28 (not explicitly shown).
- One of proximal pins 22 is secured by clamp mechanism 36 .
- cap screws 78 are positioned in a slot or track 79 on a side 84 of support member 71 .
- Set screws 78 may be used to adjust and releasably couple clamp mechanism 76 A to side 80 (not explicitly shown) of support member 71 . Such adjustment may be used to position distal pins 22 in tibial bone 122 as desired. In this embodiment, this adjustment may be performed by adjusting and fixing the position of cap screws 78 in slot 79 . Clamp mechanisms 76 A and 76 B are discussed in further detail in conjunction with FIG. 3.
- HTO device 10 is positioned at a distance H from tibial bone 122 and substantially externally to the body of the patient (not explicitly shown).
- Distance H may vary as desired, and/or according to the length of proximal and distal pins 22 .
- distance H may be sized to reduce the profile of HTO device 10 , while remaining sized large enough for palpitating the wound created by osteotomy 132 in a region between HTO device 10 and the patient's body.
- Such an advantage provides an unobstructed view of tibial bone 122 from both a medial and a lateral view that, in addition to window 60 , also desirably allows examination of and/or access to osteotomy 132 .
- Such an advantage allows a variety of examination techniques to observe the healing processes of osteotomy 132 and/or valgus and/or varus correction of bone 122 during treatment, such as radiographic and sonic imaging.
- FIG. 3 is a schematic drawing showing another isometric view of a high tibial osteotomy device incorporating teachings of the present invention.
- clamp mechanism 76 A is releasably coupled to side 80 of support member 71 by cap screws 78 .
- clamp mechanism 76 A may alternatively be releasably coupled to side 84 of support member 71 .
- Second portion 26 and first portion 24 also include surfaces 62 and 64 , respectively.
- Clamp mechanisms 36 may be selectively positioned in slot or track 31 by a variety of methods.
- cap screws 32 may be tightened to a nut 34 that is larger than slot 31 to retain clamp mechanisms 36 .
- other methods and devices may be used to tighten clamp mechanisms 36 to slot 31 including, but not limited to, bolts and threaded devices.
- distal pins 22 may be aligned and adjusted in at least two ways. First, a generally lateral position of stabilizing portion 70 with respect to angulation portion 20 may be adjusted in one or more slots 81 residing in second portion 26 . For example, bolts 82 may be used to position and tighten support member 70 to slot 81 . Second, the positions of distal pins 22 may also be adjusted to, for example, apply compression to osteotomy 132 . For example, the distance D between proximal pins 22 and distal pins 22 may be selectively expanded or contracted in a length and a direction generally parallel to tibia 122 .
- this adjustment may be performed by adjusting the position of clamp mechanisms 76 A and 76 B in slot 79 and fixing the position thereof by using cap screws 78 .
- the invention also contemplates a variety of other methods to releasably couple clamp mechanism 76 A to stabilizing portion 70 .
- adjustment portion 40 is desirably operable to rotatably couple to angulation portion 20 by using upper screw 58 and lower screw 59 to allow for such an increase.
- Upper screw 58 is operable to couple to a threaded boss portion 43 of upper cap 44
- lower screw 59 is operable to couple to a threaded boss portion 47 of body 48 .
- Bosses 43 and 47 may desirably be inserted through receptacles (not explicitly shown) of first portion 24 and second portion 26 , respectively. Such a configuration may distribute any load applied to adjustment portion 40 , thus reducing the possibility of failure by screws 58 or 59 .
- Angulation portion 40 is discussed in further detail in conjunction with FIG. 5.
- HTO device 10 may be manufactured using a variety of materials with suitable tensile properties such as, but not limited to, steel or a polymeric plastic. That is, HTO device 10 may utilize materials suitable to withstand the stresses that may be associated with compression and selective adjustment during treatment of the patient.
- HTO device 10 may be used for a period of time suitable for healing.
- a physician may provide a treatment plan that includes continuous treatment or treatment at various intervals.
- a patient may be instructed to adjust HTO device 10 by operating hex socket 42 in small increments, a number of times daily.
- Hex socket 42 is proximally disposed and easy for a patient to operate by rotating either clockwise or counterclockwise.
- Such an advantage also provides immediate angulation of osteotomy 132 , thus reducing the effective treatment period required. That is, the patient need not wait for a lengthening or distraction period to be completed before angulation begins, as with most conventional anteriorly-placed HTO devices 10 .
- This schedule may provide approximately one millimeter (1 mm) of adjustment per day.
- Such an advantage may prevent or reduce the risk of bone consolidation or solidification, while allowing bone regeneration. This may also permit full desired angulation to be achieved.
- the treatment plan may be changed over the course of healing, and may vary from patient to patient. For example, those patients who are younger and/or healthier may increase the amount of rotation and/or the daily repetition thereof.
- the patient may adjust HTO device 10 to enlarge distance D and length L in accordance with the treatment plan.
- Such enlargement provides valgus and/or varus correction by angulating bone 122 as proximal pins 22 are separated further from distal pins 22 .
- the physician may determine that valgus and/or varus correction requires extension of distance D to a new distance D′, and/or adjustment of adjustment angle ⁇ to a new angle ⁇ ′.
- One example for such an extension is discussed in further detail in conjunction with FIG. 4.
- FIG. 4 is a schematic drawing showing an isometric view of a high tibial osteotomy device with an extended window incorporating the teachings of the present invention.
- Distance D between proximal pins 22 and distal pins 22 has been extended to a new distance D′.
- length L of adjustment portion 40 (as illustrated in FIG. 1) has been extended to a new length L′.
- threaded rod 50 has been rotated by operating hex socket 42 to separate upper cap 44 from body 48 . Rotation of threaded rod 50 rotates adjustment angle ⁇ about the axis of rotation at hinge 28 .
- Adjustment angle ⁇ (as discussed in FIG. 1) has increased to an angle 0′ that is between 0.0 degrees and 90.0 degrees.
- Window 60 has also been enlarged by adjustment of adjustment portion 40 .
- a variety of techniques may be used to accommodate an increase and/or decrease in adjustment angle ⁇ as length L is increased.
- proximal and distal pins 22 maintain positioning of HTO device 10 in tibial bone 122 .
- adjustment portion 40 slightly rotates relative to first portion 24 and second portion 26 .
- Upper screw 58 and lower screw 59 allow slight rotation of adjustment portion 40 relative to first portion 24 and second portion 26 , respectively.
- FIG. 5 is a schematic drawing illustrating a cross-sectional view of an adjustment portion of the high tibial osteotomy illustrated in FIG. 3.
- the invention contemplates a variety of configurations for adjustment portion 40 .
- adjustment portion 40 includes hex socket 42 which is rigidly connected to a threaded rod 50 .
- threaded rod 50 rotates and lifts hex socket 42 a distance from body 48 .
- Threaded rod 48 may in some applications be a lifting rod that is manufactured to provide lifting capability.
- adjustment portion 40 includes upper cap 44 , barrel 46 , and body 48 .
- Threaded rod 50 is also rigidly connected by, for example, pin 53 , to a socket-containing member 52 which rotates within cap 44 .
- a nut 54 is rigidly connected to body 48 .
- Adjustment portion 40 may also include a means to stop or limit the distance that threaded rod 50 may be moved relative to body 48 .
- Other methods and devices may be used to rigidly connect various components including, but not limited to, gluing and/or welding techniques.
- socket-containing member 52 may include one or more grooves (not explicitly shown) disposed in a direction generally parallel to length L. These grooves may extend the entire length of socket-containing member 52 , or some portion thereof.
- a ball plunger assembly 57 may be used in conjunction with these grooves.
- ball plunger assembly 57 includes a threaded rod in which a ball or other protrusion resides. When a patient rotates hex socket 42 , threaded rod 50 and socket-containing member 52 may move relative to ball plunger assembly 57 , depressing the ball or protrusion into the groove of socket-containing member 52 .
- ball plunger assembly 57 may be disposed within upper screw 58 that has been adapted to receive the threaded rod.
- ball plunger assembly 57 may be used to provide such feedback. It may be desirable for the grooves to be disposed in socket-containing member 52 at ninety-degree intervals. Such a configuration may allow tactile and/or audio feedback when threaded rod 50 is rotated in a one-quarter turn increment. For example, as the ball protrudes into the groove, it may make an audible click that may be used to signal the patient that one quarter turn of hex socket 42 has been achieved. In some applications, it may be desirable to use a ball plunger assembly 57 with a ball whose diameter is one-quarter the diameter of threaded rod 50 .
- the present invention may be utilized for both the right and left limbs for both medial and lateral osteotomies. That is, angulation portion 20 may be used in conjunction with stabilizing portion 70 to control final limb alignment and apply gradual correction angulation means to either tibia 122 . Such an advantage may desirably improve the interchangeability of elements for HTO device 10 and may reduce manufacturing costs. In the embodiment illustrated in FIGS. 1 - 4 , HTO device 10 may be used in the correction of a laterally-positioned transverse osteotomy 132 on a left tibia 122 .
- HTO device 10 may be operated in similar fashion for a medially-positioned or laterally-positioned osteotomy 132 for either leg.
- angulation portion 70 may be controlled on either side of the patient's leg by appropriately reversing the center of rotation. To reverse the center of rotation, angulation portion 20 may be rotated and selected elements may be releasably coupled thereto in an alternative configuration.
- stabilizing portion 70 may be coupled to first portion 24 , rather than second portion 26 , of angulation portion 20 .
- second portion 26 would be proximally located and first portion 24 would be distally located.
- Support member 79 may then be coupled to slot 31 of first portion 24 , rather than second portion 26 , of angulation portion 20 .
- Clamp mechanisms 36 may also be coupled to slot 81 of second portion 26 , rather than first portion 24 , of angulation portion 20 so that they are once again proximally located.
- clamp mechanisms 76 A and 76 B may be releasably coupled to side 84 of stabilizing portion 70 .
- Clamp mechanisms 36 , 76 A and 76 B may also be similarly selectively adjusted so that pins 22 may be appropriately positioned, as discussed in conjunction with FIGS. 1 - 3 .
- adjustment portion 40 may also be flipped to proximally locate hex socket 42 . That is, cap 44 would be coupled to second portion 26 , and body 48 would be coupled to first portion 24 .
- a screw 58 including a ball plunger assembly may also be used to couple cap 44 to second portion 26 , if desired.
- FIGS. 6 - 8 illustrate an example of an embodiment for an osteotomy guide.
- Osteotomy guide 200 may be used by a physician to create an osteotomy 132 , and to improve the accuracy of tibial angulation by aligning osteotomy 132 with the center of rotation for HTO device 10 .
- osteotomy 132 may be created in tibia 122 at a location generally even with hinge 28 . Such alignment may improve the angulation of tibia 122 and control thereof.
- Osteotomy guide 200 may desirably be removably inserted between first portion 24 and second portion 26 to perform an osteomatic procedure. After the procedure is complete, the physician may remove and discard osteotomy guide 200 .
- FIG. 6 is a schematic drawing showing an isometric view of an osteotomy guide incorporating teachings of the present invention.
- Osteotomy guide 200 preferably includes an inner surface 202 , an outer surface 204 , first surface 206 , second surface 208 , and two edges 210 .
- Osteotomy guide 200 also preferably includes receptacle 220 , which may be generally parallel with first and second surfaces 206 and 208 .
- Osteotomy guide 200 also preferably includes two receptacles 212 .
- osteotomy guide 200 may reside in a volume whose surface is generally contoured to that of HTO device 10 .
- inner surface 202 and outer surface 202 is generally concavely shaped relative to tibia 122 .
- Osteotomy guide 200 may be formed from any semi-rigid material including, but not limited to, polycarbonate, aluminum, stainless steel, and/or acrylic. In some applications, osteotomy guide 200 may desirably be transparent or clear. Use of such materials may improve a physician's ability to view and/or control the osteotomy procedure.
- FIG. 7 is a schematic drawing showing a front view of the osteotomy guide of FIG. 6.
- FIG. 7 illustrates a scalloped and generally linear receptacle 220 that is generally parallel to first surface 206 and second surface 208 .
- the present invention also contemplates the use of other orientations and/or shapes for receptacle 220 such as an arc shape.
- Receptacle 220 is desirably disposed at a location within osteotomy guide 200 to align with hinge 28 of HTO device 10 .
- receptacle 220 is disposed nearer to first surface 206 than to second surface 208 .
- Such a configuration also provides a separation between receptacle 220 and HTO device 10 suitable for tools such as a drill.
- receptacle 220 includes a plurality of generally circular receptacles that are each adapted to receive a drill bit. This plurality of circular shaped receptacles may be equally spaced from center to center, and may facilitate creation of a generally linear osteotomy that comprises a series of holes that are drilled into tibia 122 .
- An osteotome or chisel may be used to further separate the bone tissue between the drilled holes, completing the osteotomy 132 .
- the present invention contemplates a variety of sizes for any number of receptacles.
- receptacle 220 may include eleven drill receptacles each approximately six millimeters (6 mm) in diameter, spaced approximately 4.8 mm from center to center.
- the present invention also contemplates a variety of receptacles 220 through which a variety of cutting mechanisms such as saw blades may penetrate to form osteotomy 132 .
- FIG. 8 is a schematic drawing illustrating a cross-sectional view of the osteotomy guide of FIG. 7.
- Osteotomy guide 200 may be releasably coupled to HTO device 10 using a variety of methods.
- osteotomy guide 200 may be snugly coupled to HTO device 10 by means of a screw (not explicitly shown).
- osteotomy guide 200 comprises a generally U-shaped notch 214 that generally forms to surfaces 62 or 64 of second portion 26 .
- notch 214 includes an inner portion 214 a that is shorter than an outer portion 214 b .
- Osteotomy guide 200 may be releasably coupled to HTO device 10 by placing notch 214 over surfaces 62 or 64 .
- osteotomy guide 200 may be translated along surface 62 until a desirable position has been reached. Then, screws (not explicitly shown) may be inserted through receptacles 212 to penetrate portion 214 b and snugly couple second portion 26 to inner portion 214 a .
- the physician may unscrew osteotomy guide 200 from HTO device 10 and/or discard osteotomy guide 200 .
- FIGS. 9 - 11 illustrate an alternative embodiment of an osteotomy guide incorporating teachings of the present invention.
- FIG. 9 shows osteotomy guide 250 having a generally rectangular configuration with a generally linear, smooth slot 252 .
- Slot 252 may be used as an instrument insertion slot and extends from the front face of osteotomy guide 250 to the back surface of osteotomy guide 250 .
- Slot 252 allows a drill guide (not expressly shown) to be positioned through slot 252 at different angles as holes are placed in a bone.
- Osteotomy guide 250 includes flat insert 254 with a generally thin smooth slot space 256 . Insert 254 fits into slot 252 that accommodates the drill guide. With insert 254 in osteotomy slot 252 , a surgeon may use either a saggital saw or a thin osteotome to create or complete an osteotomy.
- FIG. 10 shows insert 254 disposed within slot 252 of osteotomy guide 250 .
- FIGS. 9 and 10 illustrate thumbscrews 258 that may be placed into thumbscrew holes 260 of osteotomy guide 250 to secure osteotomy guide 250 to the fixator 10 .
- FIG. 11 shows osteotomy guide 250 attached to fixator 10 by thumbscrews 258 .
Abstract
Description
- This application is a Continuation-in-Part Application of U.S. patent application Ser. No.09/525,991 filed by Richard M. Bryant on Mar. 14, 2000 entitled “Improved High Tibial Osteotomy Method and Apparatus”, now U.S. Pat. No. ______.
- This invention relates in general to the field of medical devices and more particularly to an improved high tibial osteotomy method and apparatus.
- Procedures such as limb lengthening used to address congenital or traumatic conditions may include an orthopedic osteotomical procedure such as a high tibial osteotomy (HTO). For example, an HTO procedure may be used to treat patients who suffer from a variety of ailments including varus or valgus deformities; that is, abnormal positions of a bone of the leg or foot. This procedure may be used to adjust cartilage wear patterns and/or the distribution of stress along the tibial and knee areas. Performing valgus or varus correction typically adjusts the angulation of a tibial bone and may, in many cases, delay or eliminate the need to replace a joint such as the knee.
- Proper adjustment of limb angulation desirably includes adjustment of the bone while the bone is healing. External stabilization or fixation devices are often used to compress and properly align an osteotomy during the healing process. Multiple bone screws, wires and/or pins are often used to provide compression or to attach an external fixation device which provides compression, prevents displacement of bone or tissue fragments, and supports the bone or tissue fragments during healing. These screws, wires and/or pins may be placed through one or both cortices of bone to properly position and align the osteotomy.
- Some conventional fixation devices may be used to adjustably secure a first bone portion above an osteotomy in a position relative to a second bone portion below the osteotomy. Unfortunately, some of these devices may require physician intervention for adjustment, and/or may not allow functional use of the recovering limb while the limb is healing. For example, these devices may impair a patient's ability to walk. Furthermore, many of these devices may impair a physician's ability to monitor the healing process and/or access the area surrounding the osteotomy. For example, some conventional fixation devices may block or limit radiographic, ultrasonic and/or visual examination of a treatment site.
- In addition, some of these devices include a center of rotation that is generally aligned with a center of the tibia. These devices may require additional time for a separate distraction of the bone before the angulation adjustment process may begin, which may result in an extended treatment period. Moreover, these devices may in some cases be used to angulate a tibia with an osteotomy that is not aligned with an adjustment angle of the fixation device Such misalignment may not provide an optimal level of angulation and/or control thereof.
- From the foregoing, it may be appreciated that a need has arisen for providing an improved high tibial osteotomy device. In accordance with the teachings of the present invention, an apparatus and method are provided that substantially reduce or eliminate disadvantages and problems of conventional external fixation devices.
- One aspect of the present invention is represented by a high tibial osteotomy apparatus. The apparatus preferably includes a stabilizing portion adapted to be externally coupled to an anterior portion of a tibial bone. The apparatus may also include an angulation portion adapted to be externally coupled to another anterior portion of the tibial bone and coupled to the stabilizing portion. The angulation portion may be selectively adjustable to angulate a portion of the tibial bone about a center of rotation offset from a center of the tibial bone following an osteotomical procedure on the tibial bone.
- Another aspect of the present invention includes an osteotomy guide for placement of an osteotomy. The osteotomy guide has a generally rigid member adapted to be releasably coupled to an external fixation device. The osteotomy guide may also include a receptacle disposed in the member. The receptacle is preferably adapted to receive a plurality of instruments to be used in an osteotomical procedure on a tibial bone.
- The present invention provides several important advantages. Various embodiments of the invention may have none, some, or all of these advantages. The invention may permit a variety of monitoring activities. For example, the invention includes a window that allows access and/or visual inspection of the osteotomy. In some applications, the window may include materials that do not obstruct one or more imaging wavelengths. For example, the window may include radiolucent material that is relatively transparent to x-rays. The invention may be secured to an anterior portion of a tibial bone, permitting functional use of the recovering limb while the limb is healing. The invention includes a center of rotation offset from a center of the tibial bone. Such an advantage may reduce or eliminate the need for a separate distraction period to avoid bone impingement before beginning the process of angulation adjustment. For example, the invention may eliminate the need to wait for lengthening to be performed before angulation commences. That is, angulation may commence without waiting the approximately seven to ten days typically required for a separate lengthening or distraction period.
- The invention may also allow improved control over conventional methods. For example, the invention allows a patient to perform incremental angulation adjustments. These incremental adjustments desirably promote angulation while reducing the risk of consolidation or solidification of the bone. Such an advantage also may reduce the overall treatment time and/or improve the control in angulation.
- The invention may also permit adjustments to be performed so that an osteotomy may be properly compressed. The invention also provides for flexibility in pin placement. The invention may also be used for treatment for both a patient's left and the right limbs.
- The invention may also provide guidance to a physician in performing an osteotomy. For example, the invention may allow proper alignment of the osteotomy with a center of rotation. Such an advantage may improve the control and accuracy of the angulation adjustment process.
- For a more complete understanding of the present invention, and the advantages thereof, reference is now made to the following written description taken in conjunction with the accompanying drawings, in which:
- FIG. 1 is a schematic drawing showing an isometric view of a high tibial osteotomy device incorporating teachings of the present invention;
- FIG. 2 is a side view of a high tibial osteotomy device incorporating teachings of the present invention;
- FIG. 3 is a schematic drawing showing another isometric view of a high tibial osteotomy device incorporating teachings of the present invention;
- FIG. 4 is a schematic drawing showing an isometric view of a high tibial osteotomy device with an extended window incorporating the teachings of the present invention;
- FIG. 5 is a schematic drawing illustrating a cross-sectional view of an adjustment portion of the high tibial osteotomy illustrated in FIG. 3;
- FIG. 6 is a schematic drawing showing an isometric view of an osteotomy guide incorporating teachings of the present invention;
- FIG. 7 is a schematic drawing showing a front view of the osteotomy guide of FIG. 6;
- FIG. 8 is a schematic drawing illustrating a cross-sectional view of the osteotomy guide of FIG. 7;
- FIG. 9 is a schematic drawing showing an osteotomy guide that includes an insert;
- FIG. 10 is a schematic drawing showing an osteotomy guide with an insert positioned in a slot; and
- FIG. 11 is a schematic drawing showing a high tibial osteotomy device with an extended window incorporating an osteotomy guide with an insert.
- Preferred embodiments of the present invention and its advantages are best understood by referring to the FIGS.1-11 of the drawings, like numerals being used for like and corresponding parts of the various drawings.
- One embodiment for an
HTO device 10 incorporating various features of the present invention is discussed in detail in conjunction with FIGS. 1-5.HTO device 10 may be used in the performance and/or in the treatment of high tibial osteotomical procedures.HTO device 10 is operable to attach to an anterior portion oftibia 122 of a patient and, in some applications, a physician may perform the osteotomy afterHTO device 10 is attached totibia 122. A physician may also use an osteotomy guide to perform the osteotomy. One embodiment of an osteotomy guide incorporating various features of the present invention is discussed in detail in conjunction with FIGS. 6-8. -
HTO device 10 may be used to control the adjustment in angulation totibia 122 about a center or axis of rotation offset from longitudinal axis orlongitudinal centerline 142 oftibia 122. FIG. 1 illustrates atibia 122 that includes a generallytransverse osteotomy 132 whose penetration throughtibia 122 stops short oflateral cortex 124. - Satisfactory healing of the bone generally requires reduction and fixation of
osteotomy 132. For example, immediately after an osteotomical procedure, the osteotomy surfaces are preferably disposed adjacent to each other, and compression preferably provided at the osteotomy site to increase the area of contact between the osteotomy surfaces. Ideally, flexibility in placement and adjustment of fixation devices may improve control of the compression process. In this embodiment,HTO device 10 may be attached totibia 122 by means of stabilizing devices or pins 22.HTO device 10 is disposed substantially externally to the body of the patient (not explicitly shown). Eachpin 22 penetrates the body of the patient at a desired location and is connected totibia 122.HTO device 10 may be attached totibia 122 to both stabilizeosteotomy 132 and permit control of angulation oftibia 122. In the embodiments illustrated in FIGS. 1 and 2,HTO device 10 is operable to control angulation of amedial portion 126 oftibia 122 whilecallus tissue 128 forms therein. - FIG. 1 is a schematic drawing showing an isometric view of a high tibial osteotomy device incorporating teachings of the present invention.
HTO device 10 preferably includes anangulation portion 20 and a stabilizingportion 70.Angulation portion 20 may be used in conjunction with stabilizingportion 70 to apply gradual correction angulation means to and control final limb alignment oftibia 122. - By way of example and not by limitation,
angulation portion 20 includes a proximally locatedfirst portion 24, and at least oneclamp mechanism 36 that is releasably coupled thereto.HTO device 10 is shown with an adjustment angle θ of approximately zero degrees, where adjustment angle θ is formed in an x-y plane formed by a y axis throughhinge 28 and relative to an x axis throughhinge 28 generally parallel to surface 29 offirst portion 24. Thus,HTO device 10 is operable toangulate tibia 122 about a center of rotation centered athinge 28 that is offset fromcenter 142 oftibia 122.Angulation portion 20 also comprises anadjustment portion 40 that is operable to adjustably couplefirst portion 24 to distally locatedsecond portion 26. -
Adjustment portion 40 may be selectively adjusted to increase or decrease adjustment angle θ. This adjustment pivots abouthinge 28 and results in expansion ofmedial portion 126 oftibia 122. By way of example and not by limitation, adjustment angle θ may be selectively expanded by rotatinghex socket 42. One example of such an expansion of adjustment angle θ is illustrated and discussed in further detail in conjunction with FIG. 4.Adjustment portion 40 is disposed on an exterior side ofangulation portion 20 relative to the patient in this embodiment. The invention also contemplates anadjustment portion 40 disposed interiorly (relative to the patient) toangulation portion 20. - Also by way of example and not by limitation,
angulation portion 20 includes asecond portion 26 that is hingedly coupled tofirst portion 24 byhinge 28.Hinge 28 may be implemented using a variety of methods. In this embodiment, hinge 28 may include acylindrical pin 27 that rotatably couples cylindrically-shaped receptacles in bothsecond portion 26 tofirst portion 24. The present invention also contemplates the use of other hingeable, pivotable or rotatable means to couplesecond portion 26 tofirst portion 24. -
First portion 24,second portion 26, andadjustment portion 40 form and enclose awindow 60.Window 60 provides an unobstructed view oftibial bone 122 that desirably allows examination of and/or access toosteotomy 132. For example, the physician and/or the patient may palpitate, visually inspect and/or monitor healing of the wound created byosteotomy 132 throughwindow 60. In addition,window 60 permits an unobstructed view ofosteotomy 132 andcallus portion 128 for a variety of examination and monitoring procedures. Such an advantage allows a variety of examination techniques to be used to observe the healing processes ofosteotomy 132 and/or valgus and/or varus correction ofbone 122 during treatment. For example, procedures including, but not limited to, radiographic imaging (e.g., fluoroscopic, x-ray, magnetic resonance imaging, and computed tomography scanning techniques) and ultrasonic imaging may be used to capture unobstructed views ofcallus portion 128 at a variety of points during the healing process astibial bone 122 is angulated. - In some applications, it may be desirable for some or all of the elements within
angulation portion 20 to be manufactured using a variety of composite materials. For example, those elements forming and enclosingwindow 60 may include radiolucent materials that are transparent to radiographic wavelengths. Such an embodiment provides the advantage of a larger unobstructed imaging area through which a physician may obtain images to analyze the healing process. In this embodiment, stabilizingportion 70 includes asupport member 71 that may be releasably coupled tosecond portion 26 as discussed in further detail in conjunction with FIGS. 2 and 3. In other applications,second portion 26 and stabilizingportion 70 may include a single integrated member. Stabilizingportion 70 also includesclamp mechanisms Clamp mechanism 76A may include one or more portions and may also be releasably coupled to supportmember 71 as discussed in conjunction with FIGS. 2 and 3. -
HTO device 10 may be anteriorly mounted ontibia 122 by means of at least fourpins 22 as shown in the embodiment illustrated in FIG. 1. Twoproximal pins 22 are located aboveosteotomy 132, and twodistal pins 22 are located below osteotomy 132 a distance D fromproximal pins 22. The present invention contemplates the use of more or fewer pins. For example, in some applications it may be desirable to utilize threedistal pins 22. The present invention also contemplates the use of other means of attachingHTO device 10 totibia 122. For example,HTO device 10 may be connected totibia 122 using stabilizing devices including, but not limited to, bone screws, wires, pins or a combination thereof.Pins 22 may be manufactured using any suitable implantable grade materials. - As illustrated in FIG. 1,
proximal pins 22 are releasably secured within a slot orreceptacle 38 formed within each of twoclamp mechanisms 36. Also by way of example and not by limitation, stabilizingportion 70 includes at least one clamp mechanism operable to secureHTO device 10 to at least twodistal pins 22. In this embodiment, stabilizingportion 70 includesclamp mechanisms Clamp mechanism 76B may be releasably secured to clampmechanism 76A by adjusting cap screws 72. A plurality of slots orreceptacles 78 may be formed whenclamp mechanism 76A is coupled to clampmechanism 76B.Receptacles 78 may be generally linearly aligned as illustrated, staggered in other configurations, and/or be disposed in either or bothclamp mechanisms Distal pins 22 may be releasably secured within at least tworeceptacles 78. - A variety of methods may be used to selectably adjust the placement of
pins 22 in, and pressure applied to,tibia 122. In this embodiment, eachclamp mechanism 36 may be selectively positioned in a slot or track 31 disposed insurface 29. By way of example and not by limitation, eachclamp mechanism 36 may be translated alongfirst portion 24, and may be releasably fixed usingcap screw 32. The present invention also contemplates the use of asingle slot 31 in which both clampmechanisms 36 may be positioned, or other mechanisms for adjusting placement of proximal pins 22. Each of these elements inangulation portion 20 may reside in a volume whose surface generally corresponds with a contour of a patient's lower leg. Such a configuration may be desirable in applications where placement ofpins 22 may be selectively adjustable. Alignment and adjustment ofdistal pins 22 is discussed in conjunction with FIGS. 2 and 3. - In operation, a physician may first align and then stabilize
HTO device 10 with respect totibia 122 by inserting one or more K-wires (not explicitly shown) throughreceptacles 11 intotibia 122. In addition, the physician may also insert one or more K-wires through a receptacle inpin 27 intotibia 122. The physician may then accurately positionproximal screws 22 and then distal screws 22. In some embodiments, the physician may also releasably couple anosteotomy guide 200 toHTO device 10.Osteotomy guide 200 may be used to assist the physician in performing the osteotomical procedure, and is discussed in further detail in conjunction with FIGS. 4-6. - FIG. 2 is a side view of a high tibial osteotomy device incorporating teachings of the present invention. Where
osteotomy 132 is amedial osteotomy 132 on aright tibial bone 122, FIG. 2 illustrates a medial view ofHTO device 10. In this embodiment,first portion 24 is rotatably coupled to a generally u-shapedsecond portion 26 by hinge 28 (not explicitly shown). One ofproximal pins 22 is secured byclamp mechanism 36. By way of example and not by limitation, cap screws 78 are positioned in a slot or track 79 on aside 84 ofsupport member 71. Set screws 78 may be used to adjust and releasablycouple clamp mechanism 76A to side 80 (not explicitly shown) ofsupport member 71. Such adjustment may be used to positiondistal pins 22 intibial bone 122 as desired. In this embodiment, this adjustment may be performed by adjusting and fixing the position ofcap screws 78 inslot 79.Clamp mechanisms -
HTO device 10 is positioned at a distance H fromtibial bone 122 and substantially externally to the body of the patient (not explicitly shown). Distance H may vary as desired, and/or according to the length of proximal anddistal pins 22. For example, distance H may sized to reduce the profile ofHTO device 10, while remaining sized large enough for palpitating the wound created byosteotomy 132 in a region betweenHTO device 10 and the patient's body. Such an advantage provides an unobstructed view oftibial bone 122 from both a medial and a lateral view that, in addition towindow 60, also desirably allows examination of and/or access toosteotomy 132. Such an advantage allows a variety of examination techniques to observe the healing processes ofosteotomy 132 and/or valgus and/or varus correction ofbone 122 during treatment, such as radiographic and sonic imaging. - FIG. 3 is a schematic drawing showing another isometric view of a high tibial osteotomy device incorporating teachings of the present invention. By way of example and not by limitation,
clamp mechanism 76A is releasably coupled toside 80 ofsupport member 71 by cap screws 78. In some applications,clamp mechanism 76A may alternatively be releasably coupled toside 84 ofsupport member 71.Second portion 26 andfirst portion 24 also includesurfaces -
Clamp mechanisms 36 may be selectively positioned in slot or track 31 by a variety of methods. In this embodiment, cap screws 32 may be tightened to anut 34 that is larger thanslot 31 to retainclamp mechanisms 36. Alternatively, other methods and devices may be used to tightenclamp mechanisms 36 to slot 31 including, but not limited to, bolts and threaded devices. - In this embodiment,
distal pins 22 may be aligned and adjusted in at least two ways. First, a generally lateral position of stabilizingportion 70 with respect toangulation portion 20 may be adjusted in one ormore slots 81 residing insecond portion 26. For example,bolts 82 may be used to position and tightensupport member 70 to slot 81. Second, the positions ofdistal pins 22 may also be adjusted to, for example, apply compression toosteotomy 132. For example, the distance D betweenproximal pins 22 anddistal pins 22 may be selectively expanded or contracted in a length and a direction generally parallel totibia 122. In this embodiment, this adjustment may be performed by adjusting the position ofclamp mechanisms slot 79 and fixing the position thereof by using cap screws 78. The invention also contemplates a variety of other methods to releasablycouple clamp mechanism 76A to stabilizingportion 70. - As
hex socket 42 is rotated, the length L ofadjustment portion 40 increases. Thus,adjustment portion 40 is desirably operable to rotatably couple toangulation portion 20 by usingupper screw 58 andlower screw 59 to allow for such an increase.Upper screw 58 is operable to couple to a threadedboss portion 43 ofupper cap 44, andlower screw 59 is operable to couple to a threadedboss portion 47 ofbody 48.Bosses first portion 24 andsecond portion 26, respectively. Such a configuration may distribute any load applied toadjustment portion 40, thus reducing the possibility of failure byscrews Angulation portion 40 is discussed in further detail in conjunction with FIG. 5. -
HTO device 10 may be manufactured using a variety of materials with suitable tensile properties such as, but not limited to, steel or a polymeric plastic. That is,HTO device 10 may utilize materials suitable to withstand the stresses that may be associated with compression and selective adjustment during treatment of the patient. - In operation,
HTO device 10 may be used for a period of time suitable for healing. A physician may provide a treatment plan that includes continuous treatment or treatment at various intervals. For example, a patient may be instructed to adjustHTO device 10 by operatinghex socket 42 in small increments, a number of times daily.Hex socket 42 is proximally disposed and easy for a patient to operate by rotating either clockwise or counterclockwise. Such an advantage also provides immediate angulation ofosteotomy 132, thus reducing the effective treatment period required. That is, the patient need not wait for a lengthening or distraction period to be completed before angulation begins, as with most conventional anteriorly-placedHTO devices 10. - It may be particularly advantageous for the patient to rotate
hex socket 42 one-quarter turn four times per day. This schedule may provide approximately one millimeter (1 mm) of adjustment per day. Such an advantage may prevent or reduce the risk of bone consolidation or solidification, while allowing bone regeneration. This may also permit full desired angulation to be achieved. The treatment plan may be changed over the course of healing, and may vary from patient to patient. For example, those patients who are younger and/or healthier may increase the amount of rotation and/or the daily repetition thereof. - The patient may adjust
HTO device 10 to enlarge distance D and length L in accordance with the treatment plan. Such enlargement provides valgus and/or varus correction by angulatingbone 122 asproximal pins 22 are separated further fromdistal pins 22. For example, the physician may determine that valgus and/or varus correction requires extension of distance D to a new distance D′, and/or adjustment of adjustment angle θ to a new angle θ′. One example for such an extension is discussed in further detail in conjunction with FIG. 4. - FIG. 4 is a schematic drawing showing an isometric view of a high tibial osteotomy device with an extended window incorporating the teachings of the present invention. Distance D between
proximal pins 22 and distal pins 22 (as illustrated in FIG. 1) has been extended to a new distance D′. In addition, length L of adjustment portion 40 (as illustrated in FIG. 1) has been extended to a new length L′. In this embodiment, threadedrod 50 has been rotated by operatinghex socket 42 to separateupper cap 44 frombody 48. Rotation of threadedrod 50 rotates adjustment angle θ about the axis of rotation athinge 28. Adjustment angle θ (as discussed in FIG. 1) has increased to anangle 0′ that is between 0.0 degrees and 90.0 degrees. -
Window 60 has also been enlarged by adjustment ofadjustment portion 40. A variety of techniques may be used to accommodate an increase and/or decrease in adjustment angle θ as length L is increased. For example, proximal anddistal pins 22 maintain positioning ofHTO device 10 intibial bone 122. In addition, in this embodiment,adjustment portion 40 slightly rotates relative tofirst portion 24 andsecond portion 26.Upper screw 58 andlower screw 59 allow slight rotation ofadjustment portion 40 relative tofirst portion 24 andsecond portion 26, respectively. - FIG. 5 is a schematic drawing illustrating a cross-sectional view of an adjustment portion of the high tibial osteotomy illustrated in FIG. 3. The invention contemplates a variety of configurations for
adjustment portion 40. For example,adjustment portion 40 includeshex socket 42 which is rigidly connected to a threadedrod 50. In operation, as a patient rotateshex socket 42, threadedrod 50 rotates and lifts hex socket 42 a distance frombody 48. Threadedrod 48 may in some applications be a lifting rod that is manufactured to provide lifting capability. - In this embodiment,
adjustment portion 40 includesupper cap 44,barrel 46, andbody 48. Threadedrod 50 is also rigidly connected by, for example,pin 53, to a socket-containingmember 52 which rotates withincap 44. Anut 54 is rigidly connected tobody 48.Adjustment portion 40 may also include a means to stop or limit the distance that threadedrod 50 may be moved relative tobody 48. For example, it may be desirable in some applications for threadedrod 50 to include apin 56 that protrudes from threadedrod 50. This pin may travel in the threads ofbody 48 and stop the movement of threadedrod 50 throughnut 54. Other methods and devices may be used to rigidly connect various components including, but not limited to, gluing and/or welding techniques. - In some embodiments, it may also be desirable to reduce or prevent slippage of threaded
rod 50. For example, socket-containingmember 52 may include one or more grooves (not explicitly shown) disposed in a direction generally parallel to length L. These grooves may extend the entire length of socket-containingmember 52, or some portion thereof. Aball plunger assembly 57 may be used in conjunction with these grooves. For example,ball plunger assembly 57 includes a threaded rod in which a ball or other protrusion resides. When a patient rotateshex socket 42, threadedrod 50 and socket-containingmember 52 may move relative toball plunger assembly 57, depressing the ball or protrusion into the groove of socket-containingmember 52. When the next groove is reached, the ball protrudes from the threaded rod into the groove, effectively limiting movement of threadedrod 50 by means of friction. In one embodiment of the invention and as illustrated in FIG. 5,ball plunger assembly 57 may be disposed withinupper screw 58 that has been adapted to receive the threaded rod. - In some embodiments, it may also be desirable to provide a patient with tactile and/or audible feedback as the patient operates
hex socket 42. As one example,ball plunger assembly 57 may be used to provide such feedback. It may be desirable for the grooves to be disposed in socket-containingmember 52 at ninety-degree intervals. Such a configuration may allow tactile and/or audio feedback when threadedrod 50 is rotated in a one-quarter turn increment. For example, as the ball protrudes into the groove, it may make an audible click that may be used to signal the patient that one quarter turn ofhex socket 42 has been achieved. In some applications, it may be desirable to use aball plunger assembly 57 with a ball whose diameter is one-quarter the diameter of threadedrod 50. - The present invention may be utilized for both the right and left limbs for both medial and lateral osteotomies. That is,
angulation portion 20 may be used in conjunction with stabilizingportion 70 to control final limb alignment and apply gradual correction angulation means to eithertibia 122. Such an advantage may desirably improve the interchangeability of elements forHTO device 10 and may reduce manufacturing costs. In the embodiment illustrated in FIGS. 1-4,HTO device 10 may be used in the correction of a laterally-positionedtransverse osteotomy 132 on aleft tibia 122. -
HTO device 10 may be operated in similar fashion for a medially-positioned or laterally-positionedosteotomy 132 for either leg. For example,angulation portion 70 may be controlled on either side of the patient's leg by appropriately reversing the center of rotation. To reverse the center of rotation,angulation portion 20 may be rotated and selected elements may be releasably coupled thereto in an alternative configuration. For example, stabilizingportion 70 may be coupled tofirst portion 24, rather thansecond portion 26, ofangulation portion 20. Thus, in this embodiment,second portion 26 would be proximally located andfirst portion 24 would be distally located. -
Support member 79 may then be coupled to slot 31 offirst portion 24, rather thansecond portion 26, ofangulation portion 20.Clamp mechanisms 36 may also be coupled to slot 81 ofsecond portion 26, rather thanfirst portion 24, ofangulation portion 20 so that they are once again proximally located. Similarly,clamp mechanisms side 84 of stabilizingportion 70.Clamp mechanisms - In addition,
adjustment portion 40 may also be flipped to proximally locatehex socket 42. That is,cap 44 would be coupled tosecond portion 26, andbody 48 would be coupled tofirst portion 24. Ascrew 58 including a ball plunger assembly may also be used to couplecap 44 tosecond portion 26, if desired. - FIGS.6-8 illustrate an example of an embodiment for an osteotomy guide.
Osteotomy guide 200 may be used by a physician to create anosteotomy 132, and to improve the accuracy of tibial angulation by aligningosteotomy 132 with the center of rotation forHTO device 10. For example,osteotomy 132 may be created intibia 122 at a location generally even withhinge 28. Such alignment may improve the angulation oftibia 122 and control thereof.Osteotomy guide 200 may desirably be removably inserted betweenfirst portion 24 andsecond portion 26 to perform an osteomatic procedure. After the procedure is complete, the physician may remove and discardosteotomy guide 200. - FIG. 6 is a schematic drawing showing an isometric view of an osteotomy guide incorporating teachings of the present invention.
Osteotomy guide 200 preferably includes aninner surface 202, anouter surface 204,first surface 206,second surface 208, and twoedges 210.Osteotomy guide 200 also preferably includesreceptacle 220, which may be generally parallel with first andsecond surfaces Osteotomy guide 200 also preferably includes tworeceptacles 212. In some applications,osteotomy guide 200 may reside in a volume whose surface is generally contoured to that ofHTO device 10. In this embodiment,inner surface 202 andouter surface 202 is generally concavely shaped relative totibia 122. -
Osteotomy guide 200 may be formed from any semi-rigid material including, but not limited to, polycarbonate, aluminum, stainless steel, and/or acrylic. In some applications,osteotomy guide 200 may desirably be transparent or clear. Use of such materials may improve a physician's ability to view and/or control the osteotomy procedure. - FIG. 7 is a schematic drawing showing a front view of the osteotomy guide of FIG. 6. FIG. 7 illustrates a scalloped and generally
linear receptacle 220 that is generally parallel tofirst surface 206 andsecond surface 208. The present invention also contemplates the use of other orientations and/or shapes forreceptacle 220 such as an arc shape. -
Receptacle 220 is desirably disposed at a location withinosteotomy guide 200 to align withhinge 28 ofHTO device 10. In the embodiment shown,receptacle 220 is disposed nearer tofirst surface 206 than tosecond surface 208. Such a configuration also provides a separation betweenreceptacle 220 andHTO device 10 suitable for tools such as a drill. In this embodiment,receptacle 220 includes a plurality of generally circular receptacles that are each adapted to receive a drill bit. This plurality of circular shaped receptacles may be equally spaced from center to center, and may facilitate creation of a generally linear osteotomy that comprises a series of holes that are drilled intotibia 122. An osteotome or chisel may be used to further separate the bone tissue between the drilled holes, completing theosteotomy 132. The present invention contemplates a variety of sizes for any number of receptacles. For example,receptacle 220 may include eleven drill receptacles each approximately six millimeters (6 mm) in diameter, spaced approximately 4.8 mm from center to center. The present invention also contemplates a variety ofreceptacles 220 through which a variety of cutting mechanisms such as saw blades may penetrate to formosteotomy 132. - FIG. 8 is a schematic drawing illustrating a cross-sectional view of the osteotomy guide of FIG. 7.
Osteotomy guide 200 may be releasably coupled toHTO device 10 using a variety of methods. In this embodiment,osteotomy guide 200 may be snugly coupled toHTO device 10 by means of a screw (not explicitly shown). - By way of example and not by limitation,
osteotomy guide 200 comprises a generallyU-shaped notch 214 that generally forms tosurfaces second portion 26. As illustrated,notch 214 includes an inner portion 214 a that is shorter than an outer portion 214 b.Osteotomy guide 200 may be releasably coupled toHTO device 10 by placingnotch 214 oversurfaces osteotomy guide 200 may be translated alongsurface 62 until a desirable position has been reached. Then, screws (not explicitly shown) may be inserted throughreceptacles 212 to penetrate portion 214 b and snugly couplesecond portion 26 to inner portion 214 a. After the osteotomical procedure has been performed, the physician may unscrewosteotomy guide 200 fromHTO device 10 and/or discardosteotomy guide 200. - FIGS.9-11 illustrate an alternative embodiment of an osteotomy guide incorporating teachings of the present invention. FIG. 9 shows
osteotomy guide 250 having a generally rectangular configuration with a generally linear,smooth slot 252.Slot 252 may be used as an instrument insertion slot and extends from the front face ofosteotomy guide 250 to the back surface ofosteotomy guide 250.Slot 252 allows a drill guide (not expressly shown) to be positioned throughslot 252 at different angles as holes are placed in a bone.Osteotomy guide 250 includesflat insert 254 with a generally thinsmooth slot space 256.Insert 254 fits intoslot 252 that accommodates the drill guide. Withinsert 254 inosteotomy slot 252, a surgeon may use either a saggital saw or a thin osteotome to create or complete an osteotomy. - FIG. 10 shows insert254 disposed within
slot 252 ofosteotomy guide 250. FIGS. 9 and 10 illustratethumbscrews 258 that may be placed intothumbscrew holes 260 ofosteotomy guide 250 to secureosteotomy guide 250 to thefixator 10. FIG. 11shows osteotomy guide 250 attached tofixator 10 bythumbscrews 258. - Although the present invention and its advantages have been described in detail it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the invention as defined by the following claims.
Claims (26)
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US10/180,864 US20020164905A1 (en) | 2000-03-14 | 2002-06-26 | Osteotomy guide and method |
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US09/525,992 US6423061B1 (en) | 2000-03-14 | 2000-03-14 | High tibial osteotomy method and apparatus |
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Also Published As
Publication number | Publication date |
---|---|
US6423061B1 (en) | 2002-07-23 |
CA2340542A1 (en) | 2001-09-14 |
EP1136041A2 (en) | 2001-09-26 |
EP1136041A3 (en) | 2003-10-01 |
JP2001293004A (en) | 2001-10-23 |
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