JOINT FUSION SYSTEMS AND DEVICES
20230190351 · 2023-06-22
Assignee
Inventors
- JOSEPH JOHNSTON (Houston, TX, US)
- PEDRO COSCULLUELA (Houston, TX, US)
- TRAVIS BRYAN (Houston, TX, US)
- THOMAS BLACKBURN (Houston, TX, US)
Cpc classification
A61F2002/4233
HUMAN NECESSITIES
A61F2002/30622
HUMAN NECESSITIES
A61B17/8863
HUMAN NECESSITIES
A61F2/4606
HUMAN NECESSITIES
A61B2017/565
HUMAN NECESSITIES
International classification
A61B17/88
HUMAN NECESSITIES
A61B17/80
HUMAN NECESSITIES
Abstract
A device for bending joint fusion plates to a precise degree of bend, and methods of using same. The bender has three pressure points, two that sit under the plate and one above, and compressing the handle will bend the plate to a desired degree as there is a stop point that can be set by the user for the degree of bend. The bender allows the surgeon to bend the plate prior to surgery, thus avoiding having to bend the plate during the surgery as in current practice. Kits and systems are also provided.
Claims
1) A bender for precise bending of a separate joint fusion plate, said bender comprising: a) a main body having a hollow therein and having first and second pressure points protruding from an exterior surface near a top end of said main body and a first slot between said first and second pressure points; b) a stop shaft inside said hollow and means for controlling a height of said stop shaft inside said hollow; c) a travelling jaw having a lower end at least partially inside said hollow, said travelling jaw having a third pressure point at an upper end of said travelling jaw, said third pressure point positioned between said first and second pressure points in said slot; d) said travelling jaw able to travel up to allow placement of a separate joint fusion plate between said first and second pressure points and said third pressure point, and able to travel down to meet said stop shaft; e) a handle operatively connected to said main body and to said travelling jaw, said handle for raising and lowering said travelling jaw and for applying a pressure to said third pressure point when said separate joint fusion plate is positioned in a stable and unmoving position supported by said first and second pressure points, thereby bending said separate joint fusion plate.
2) The bender of claim 1, wherein said means for controlling said height of said stop shaft is a rotating dial at a bottom of said main body that raises and lowers said stop shaft via a threaded region that mates with a threaded region inside said hollow.
3) The bender of claim 2, wherein said dial has markings thereon for indicating a degree of bending.
4) The bender of claim 1, wherein said travelling jaw is biased to return to a lowered position.
5) The bender of claim 1, wherein said travelling jaw is spring biased to return to a lowered position with a spring connected to said main body and to said travelling jaw.
6) The bender of claim 1, wherein said handle is hingedly connected to said main body and to said travelling jaw via a drag link, said main body having a second slot opposite said first slot, said second slot allowing said drag link to travel up and down said main body with said handle.
7) The bender of claim 1, wherein said handle is hingedly connected to said main body and to said travelling jaw via a drag link, said main body having a second slot opposite said first slot, said second slot allowing said travelling jaw to travel up and down with said handle, wherein said travelling jaw is spring biased to return to a lowered position, said spring connected to said main body and to said travelling jaw.
8) The bender of claim 1, wherein said main body, said handle, and said travelling jaw are made of metal.
9) The bender of claim 1, wherein said first and second pressure points are integral to said main body and wherein said third pressure point is integral to said travelling jaw.
10) The bender of claim 1, wherein said first and second pressure points are not integral to said main body, but comprise a first separate attachable component, and wherein said third pressure point is not integral to said travelling jaw but comprises a second separate attachable component.
11) The bender of claim 1, wherein said first and second pressure points have an upper surface that mirrors a lower surface of said separate joint fusion plate and said third pressure point has a lower surface that mirrors a upper surface of said separate joint fusion plate.
12) A kit for joint fusions, said kit being a container comprising: a) the bender of claim 1; and b) a plurality of metal joint fusion plates having a shape, said shape designed to i) fit against two bones to be fused and a plurality of holes for attachment means to travel therethrough and into said two bones and ii) fit into said bender.
13) The kit of claim 12, further comprising one or more of: a) instructions for use; b) at least two known angle bent plates for calibrating said bender; c) said plurality of metal joint fusion plates being in a plurality of sizes; or d) said shape fitting against a phalanx bone and a metatarsal bone.
14) A method for fusing two bones, said method comprising: a) obtaining a radiograph of two bones to be fused, said two bones positioned to have a desired angle therebetween; b) measuring said desired angle from said radiograph; c) bending a joint fusion plate to have said desired angle using the bender of claim 1; and d) surgically installing said bent joint fusion plate onto said two bones.
15) The method of claim 14, wherein said bent joint fusion plate is sterilized after bending and before use.
16) The method of claim 14, wherein said bent joint fusion plate is sterilized before bending and said bending step c) is performed in a sterile manner.
17) The method of claim 14, said method being for fusing a phalanx bone and a metatarsal bone, said method comprising: a) obtaining a radiographic image of a foot having a phalanx bone and a metatarsal bone to be fused by positioning said foot on a ¾-1 inch heel block, applying weight to said foot and taking said radiographic image; b) measuring an angle between said phalanx bone and said metatarsal bone from said radiographic image; c) bending a joint fusion plate to have said angle using the bender of claim 1; and d) surgically installing said bent joint fusion plate onto said phalanx bone and said metatarsal bone.
18) The method of claim 17, wherein steps a-c) occur before step d) is initiated.
19) The method of claim 17, wherein steps a-b) occur before step d) is initiated.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0064] The disclosure provides novel joint fusion plates, as well as a dedicated bender device that allows a very precise and reproducible degree of bending of any plate. We exemplify the invention herein with respect to a hallux MTP plate, but the same principles can be applied to any joint fusion plate, and the shapes adjusted accordingly.
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[0067] In more detail,
[0068] The fasteners themselves are not shown, and can be any known in the art or to be developed, including locking screws, such as those by Flower Orthopedics, or self-compressing screws that have an asymmetrical head and function to pull the joints together as they are tightened and seat in a specially shaped screw head in the plate, such as the general purpose compression bone screw by TST Medical Devices.
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[0071] In the side view of
[0072] In
[0073] As yet another alternative, small inexpensive plastic adaptors for each plate size and style can fit into a depression or receptacle or pin in the bender or on a protruding pin, allowing a large number of plates to all be bent using the same bender. Since the adaptors are mere plastic pieces, each having a front side that mirrors the various plates, and a back side that mirrors the single bender style, this may be a cost effective approach for a custom fit to each plate.
[0074] Shape mirroring is not essential, however, and a marking on the plate may be employed (e.g. a center line to line up with the upper pressure point, or three lines to line up with the three pressure points) instead of dedicated fitting components, allowing a variety of different plates to be bent using the same bender, provided their sizes are compatible with a given bender. With this methodology, e.g., all finger and toe plates may be bent with the same bender, but a larger joint, such as elbow, will probably need a larger bender.
[0075] In use, the handle 402 is lifted to provide a space between posts 420 and travelling jaw 403. Plate 404 is thus inserted into this space to fit on top of posts 420 and when correctly positioned, the travelling jaw 403 directly lines up with bend line 314 (from
[0076] Spring 406 serves to tension the handle 402 so that it fits gently against plate 404, holding it steady until the user is ready to apply pressure. When the user applies a closing pressure to the handle 402, travelling jaw 403 is forced downwards as far as the calibrator and stop shaft 407 will allow and the plate 404 is thereby accurately bent to the designated angle.
[0077] The various additional parts including draglink 405 connecting handle 402 to main body 401, spring 406 tensioning the handle 402 and travelling jaw 403 via drag link 405, and the various couplings holding the parts movably together. Here we have used pin link 413, pin hinge 412, 415 (two sizes), retaining ring 414, 416 (two sizes), but any other fasteners can be used that allow the needed movement between the parts.
[0078] The details of the angle dialing components are shown in the cross section of
[0079] This embodiment of the device has two sets of threaded parts, including calibration threads 422 and dial threads 423. A single set of threads would suffice, but the dual system allows fine calibration of the dial. In more detail, the external threads of calibrator and jaw stop 407 mate with the internal threads of angle set shaft 408 to provide calibration threads 422 allowing fine calibration by turning the distal-most end of calibrator and jaw stop 407, which protrudes beyond dial 409. The external threads of 408 mate with the internal threads of hollow body 401 to form dial threads 423, wherein turning dial 409 moves the combined parts 407 and 408 up and down, thereby setting the bending angle by raising or lowering the stop 407. Some of these details may be better viewed in
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[0083] Just above the square section is an internally threaded section 408.6 which allows threaded coupling to 407. Above to 408.6 is an externally threaded section 408.4 which mates with a threaded area in the hollow inside body 401 (not visible, except in
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[0085] Another embodiment of a dial 409 is shown in
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[0087] In more detail,
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Preoperative Procedure
[0091] The patient typically presents to the clinic for evaluation of pain along the hallux metatarsophalangeal joint with or without deformities. The most common indications for consideration of a fusion are: 1) hallux rigidus—arthritis of the great toe metatarsophalangeal joint, 2) hallux valgus—bunion, and 3) hallux varus—inward turn of the great toe.
[0092] During the typical evaluation, 3 radiographic views of the foot are taken in the office—an anterior-to-posterior view, an oblique view, and a lateral view. These views are typically centered along the mid portion of the foot to have a broad assessment of the foot. If it is determined that a fusion of the hallux metatarsophalangeal joint is the best treatment option, a fourth view of the foot in the lateral plane is performed as follows:
[0093] The foot is placed on the foot board with the heel on the ¾ inch heel simulator and the patients stand with weight on that foot, the other foot pulled up out of the line of the beam. A small footstool can be placed forward of the X-rayed foot to make it easier for the patient to hold the foot out of the line of the beam. Care is taken to ensure that the toes are flat on the footboard and the radiographic beam is centered on the metatarsal head. This final radiograph—the “Templating View”—is used in order to allow for better measuring of the dorsal (top) aspect of the metatarsal shaft and the proximal phalanx.
[0094] Once the templating view radiograph is available, a measurement of the angle between the constant portion of the metatarsal shaft dorsally and the constant portion of the proximal phalanx dorsally is performed as shown in
Intra-Operative Procedure
[0095] A standard dorsal—top of the foot—approach to the hallux metatarsophalangeal joint is carried out according to methods known in the art and described briefly here.
[0096] The dissection is carried down through the skin and the subcutaneous tissue with the scalpel. Scissors are then used to explore the proximal aspect of the incision for the medial branch of the superficial peroneal nerve. With the nerve protected, the extensor hallucis longus tendon is exposed.
[0097] The extensor hallucis longus tendon is then carefully elevated away from the underlying periosteum and capsule and retracted medially or laterally in order to expose the dorsal capsule of the hallux metatarsophalangeal joint.
[0098] The capsule is then incised along the mid portion following the same line of the incision and the tissues are elevated medially and laterally. It is important to release the medial and lateral capsular ligaments to allow for proper plantarflexion of the joint for preparation of the fusion surfaces. The toe is then plantarflexed—bent down—to allow for preparation of the metatarsal head. With the toe bent down, the hallux metatarsal is cannulated—pinned—with a K-wire following the line of the bone.
[0099] With the toe pinned, a cup reamer is then used to prepare the surface of the metatarsal head and remove the main layer of residual cartilage.
[0100] Once the main layer of cartilage is removed, the reamer and the pin are removed, and attention is then directed toward the base of the proximal phalanx. The phalanx is pinned with a K-wire of the same size following the axis of the bone. The base of the proximal phalanx is then reamed using a cone reamer over the above wire.
[0101] After the cartilage is removed, the reamer and the K-wire are removed from the joint. Both sides of the joint are then evaluated for any residual cartilage which, if present, is removed with a key elevator, curette, or rongeur. The wound is then copiously irrigated to remove any debris. The wound is dried with suction and both sides of the joint are drilled with a small drill bit to stimulate bleeding and aid in the fusion of the joint.
[0102] Traditionally, the next step in this procedure involves placing the toe in proper alignment and pinning the toe with a K-wire while holding that alignment. The position of the toe is then evaluated with a foot plate to make sure that it matches the posture of the other toes and allows the patient to use a heel of up to 1″. The problem with this approach is that it is user dependent, not reproducible, and is time consuming. To avoid this, we developed a plate first approach to the fixation.
Plate-First Fixation
[0103] While the surgeon is performing the approach to the toe, the 0 (zero) degree plate is opened in sterile fashion and a sterile bender described herein to give the plate the proper degree of dorsiflexion based on the pre-operative template. Alternatively, this can be done in advance and the plate autoclaved or otherwise sterilized obviating the need for sterile technique.
[0104] Once the toe has been prepared for fusion using the above technique, the plate is brought into the field and positioned over the joint. Care is taken to hold the toe in proper rotation and longitudinal alignment (valgus). The plate is then pinned to the bone on both sides of the joint with threaded olive wires in order to hold the toe in alignment with the plate.
[0105] The position of the toe is confirmed visually in both the front and lateral planes. A ¾″ template, similar to or the same as the one used to measure the angles pre-operatively, is then used to confirm that the toe position matches the templated position.
[0106] After confirmation of proper alignment and position of the plate visually and radiographically, the trans-articular screw is addressed. While the plate is holding the toe in proper alignment, a K-wire from the cannulated screw set is brought into the field and the toe is pinned. Placement of the K-wire is confirmed with fluoroscopy. A small incision is then made at the entry site of the wire into the skin and the wire is drilled with a cannulated drill bit. The screw is then inserted over the wire and across the joint.
[0107] Prior to compressing the joint, the proximal olive wire is removed and only the wire in the oblong wire hole is left in place. This allows for compression of the joint while the plate is still over the joint, the plate can move proximally over the oblong hole without a change in overall position of the plate.
[0108] Once compressed, the only thing left to do is drill the holes on the plate and replace with screws. There is no need to reposition the plate in any way. When all of the hardware has been placed, surgery is completed and final radiographs are taken in the anteroposterior and lateral planes to confirm hardware placement and toe position.
[0109] Done in this manner, the procedure is reproducible in the vast majority of cases without having to depend on eyeballing of the position of the toe or the experience of the surgeon. It is also performed knowing that the position of the toe will allow for the patient to wear a standard heel as that measurement was performed with the patient weightbearing.
[0110] The present invention was exemplified in detail with respect to a hallux plate, bender and foot guide. However, this is exemplary only, and the invention can be broadly applied to other joints, such as e.g., other toes, fingers, elbows, and the like, and the components reshaped as needed for the different joints.
[0111] The following references are incorporated by reference in their entirety for all purposes.
[0112] U.S. Pat. No. 5,564,302 Orthopedic bone plate bending irons
[0113] U.S. Pat. No. 8,167,918 Orthopedic plate for use in the mtp joint
[0114] U.S. Pat. No. 8,419,745 Bone plate bender system
[0115] U.S. Pat. No. 9,615,874 Bone plate shaping system
[0116] The following commercial system are also available:
[0117] Synthes large plate bender
[0118] Arthrex MaxForce MTP compression plate
[0119] Acumed MP fusion plate
[0120] Biomet ALPS MP fusion plate
[0121] In2Bones Neo-fit MP fusion plates
[0122] Medartis Hallux System 2.8
[0123] OrthoSolutions Volition Foot Plating System
[0124] Synthes 2.4/2.7 Variable Angle Forefoot/Midfoot Set
[0125] Wright Medical Ortholoc MTP fusion plate
[0126] Wright Medical Ortholoc 2 Crosscheck MTP fusion plate.