Internal ankle fixation systems, foot securement and jig devices, and related methods
11547456 ยท 2023-01-10
Assignee
Inventors
Cpc classification
A61B17/7241
HUMAN NECESSITIES
A61B17/7291
HUMAN NECESSITIES
A61B17/1725
HUMAN NECESSITIES
A61B17/88
HUMAN NECESSITIES
A61B2017/681
HUMAN NECESSITIES
International classification
Abstract
Embodiments described herein provide an implant for rigid intramedullary fixation of the hindfoot complex with the midfoot and/or forefoot and methods of implanting the same. Embodiments described herein can allow for the implant to be adapted to the patient based upon the extent of bone loss and instability. Embodiments herein also provide a jig system to facilitate the shaping of the foot and/or the implantation of the described internal fixation systems.
Claims
1. An internal fixation ankle support system comprising: a first elongated fastener configured to be inserted into bone and having a length that is sufficient to extend between and into a talus and a metatarsal of a patient when implanted; a second elongated fastener configured to be inserted into bone and having a length that is sufficient to extend into a calcaneus, a talus, and optionally a tibia of a patient when implanted; and a third elongated fastener configured to be inserted into bone and having a length that is sufficient to extend between and into a talus and at least one of a cuboid or a cuneiform of a patient when implanted, wherein the second elongated fastener comprises a first hole configured to receive the first elongated fastener along a first axis, whereby the first elongated fastener extending through the first hole is intersecting the second elongated fastener, wherein the second elongated fastener comprises a second hole configured to receive the third elongated fastener along a second axis, whereby the third elongated fastener extending through the second hole is intersecting the second elongated fastener, and wherein one or more of the first elongated fastener member and third elongated fastener member is configured for polyaxial coupling and locking in relation to the second elongated fastener.
2. The internal fixation ankle support system of claim 1 further comprising: a fourth elongated fastener configured to be inserted into bone and having a length that is sufficient to extend between and into a talus and at least one of a cuboid or a cuneiform of a patient when implanted; wherein the second elongated fastener comprises a third hole configured to receive the fourth elongated fastener along a third axis, whereby the fourth elongated fastener extending through the third hole is intersecting the second elongated fastener.
3. The internal fixation ankle support system of claim 2, wherein the first or third elongated fastener comprises an outer elongated body comprising a longitudinal bore and an elongated reinforcing member configured to be inserted into the longitudinal bore.
4. The internal fixation ankle support system of claim 3, wherein the reinforcing member is composed of a material that has a higher elastic modulus than the outer elongated body.
5. The internal fixation ankle support system of claim 2, wherein the second elongated fastener is longer than the first elongated fastener.
6. The internal fixation ankle support system of claim 5, wherein the first elongated fastener is at least 1.5 times the length of the third elongated fastener or fourth elongated fastener and wherein the second elongated fastener is longer than the third elongated fastener or fourth elongated fastener.
7. The internal fixation ankle support system of claim 6, wherein a transverse dimension of the second elongated fastener is greater than a transverse dimension of the first, third and fourth elongated fasteners, individually.
8. The internal fixation ankle support system of claim 7, wherein a transverse dimension of the first elongated fastener is greater than a transverse dimension of the third elongated fastener or fourth elongated fastener.
9. The internal fixation ankle support system of claim 2, wherein one or more of the second axis and the third axis is perpendicular or oblique relative to the longitudinal axis of the second elongated fastener.
10. The internal fixation ankle support system of claim 9, further comprising one or more of: the first axis being skew relative to the second axis, the first axis being skew relative to the third axis, or the second axis being skew relative to the third axis.
11. The internal fixation ankle support system of claim 2, wherein the second hole and the third hole are located between the second end of the second elongated fastener and the first hole.
12. The internal fixation ankle support system of claim 11, wherein the second elongated fastener further comprises a fourth hole that is located between the first end and the first hole.
13. The internal fixation ankle support system of claim 12, wherein the second elongated fastener further comprises a first slot that is located between the fourth hole and the first hole.
14. The internal fixation ankle support system of claim 13, wherein the second elongated fastener further comprises a second slot that is located between the first slot and the first hole.
15. The internal fixation ankle support system of claim 2, wherein the second elongate fastener comprises a longitudinal bore having an internal thread and being accessible at the second end and a compression screw configured to be inserted into the longitudinal bore to move the first, second, and third elongate fasteners in the direction of the longitudinal axis of the fourth elongate fastener.
16. The internal fixation ankle support system of claim 1, wherein the first axis and the longitudinal axis of the second elongated fastener are oblique.
17. The internal fixation ankle support system of claim 1, wherein the first end of the second elongated fastener is tapered.
18. An internal fixation ankle support system comprising: a first elongated fastener configured to be inserted into bone and having a length that is sufficient to extend between and into a talus and a metatarsal of a patient when implanted; a second elongated fastener configured to be inserted into bone and having a length that is sufficient to extend into a calcaneus, a talus, and optionally a tibia of a patient when implanted; and a third elongated fastener configured to be inserted into bone and having a length that is sufficient to extend between and into a talus and at least one of a cuboid or a cuneiform of a patient when implanted, wherein the second elongated fastener comprises a first hole configured to receive the first elongated fastener along a first axis, whereby the first elongated fastener extending through the first hole is intersecting the second elongated fastener, a fourth elongated fastener configured to be inserted into bone and having a length that is sufficient to extend between and into a talus and at least one of a cuboid or a cuneiform of a patient when implanted; wherein the second elongated fastener comprises a third hole configured to receive the fourth elongated fastener along a third axis, whereby the fourth elongated fastener extending through the third hole is intersecting the second elongated fastener, wherein the second elongated fastener comprises a second hole configured to receive the third elongated fastener along a second axis, whereby the third elongated fastener extending through the second hole is intersecting the second elongated fastener, and wherein one or more of the first elongated fastener member, third elongated fastener member or fourth elongated fastener member is configured for polyaxial coupling to couple in fixed and fully-inserted relation to the second elongated fastener at an angle selected from a plurality of angles by a surgeon.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The drawings illustrate only example embodiments of an internal ankle fixation and stabilization system and of a foot securement and jig device and are therefore not to be considered limiting of its scope.
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DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
(19) An embodiment of an internal ankle fixation system according to the invention is illustrated in
(20) Fourth elongated fastener 400 has a longitudinal axis 401 extending between a first end 402 and a second end 403 of the fourth elongated fastener and is configured to intersect with the first, second and third elongated fasteners 100, 200, 300. Fourth elongated fastener 400 comprises a first hole 410 configured to receive the first elongated fastener 100 along a first axis 411, a second hole 420 configured to receive the second elongated fastener 200 along a second axis 421, and a third hole 430 configured to receive the third elongated fastener 300 along a third axis 431. Second hole 420 and third hole 430 are located between the second end 403 of fourth elongated fastener 400 and first hole 410. Each of elongated fasteners 100, 200, 300 when extending through a respective hole 410, 420, 430 is intersecting fourth elongated fastener 400.
(21) Fourth elongated fastener 400 can be configured to be initially inserted into a calcaneus bone and into the talus bone. First end 402 of fourth elongated fastener 400 is more tapered and/or has a smaller transverse dimension than the second end 403, as the first end 402 is the end that will be first inserted. In the embodiment shown, fourth elongated fastener 400 is an intramedullary nail.
(22) Internal ankle fixation system 10 is configured to provide fixation of the midfoot or the midfoot and forefoot coupled to fixation of the hindfoot. In particular, first, second, and third elongated fasteners 100, 200, 300 are configured to have the size (length and dimension) and shape that facilitates insertion into a particular foot bone for purposes of fixation relative to the talus bone. For example, in some embodiments, first elongated fastener 100 has a length that is sufficient to extend between and into a talus and a first metatarsal of a patient when implanted. In addition, first hole 410 is configured such that first axis 411 would intersect with the first metatarsal when fourth elongated fastener 400 is implanted in a patient. In some embodiments, second elongated fastener 200 has a length that is sufficient to extend between and into a calcaneus and a second cuneiform of a patient when implanted, and second hole 420 is configured such that second axis 421 would intersect with the second cuneiform when fourth elongated fastener 400 is implanted in a patient. In some embodiments, third elongated fastener 300 has a length that is sufficient to extend between and into a calcaneus and a cuboid of a patient when implanted, and third hole 430 is configured such that third axis 431 would intersect with the cuboid when fourth elongated fastener 400 is implanted in a patient.
(23) To accommodate the differences in the sizes of bones in the hindfoot relative to the midfoot or forefoot, the first, second; and third elongated fasteners 100, 200, 300 can be tapered along the length or a portion thereof, the smaller outer diameter section being intended for the midfoot or the forefoot.
(24) Moreover, in some embodiments, first elongated fastener 100 can be longer than the second and third elongated fasteners 200, 300. First elongated fastener 100 can be at least 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 210% or 220% the length of the second and/or third elongated fastener 200, 300. Second elongated fastener 200 can be longer than the third elongated fastener 300, such as at least 105%, 108%, 110%, 113%, 115%, 118%, 120%, 123%, 125% or 130% longer.
(25) In some embodiments, fourth elongated fastener 400 has a transverse dimension that is greater than that of each of the other elongated fasteners 100, 200, 300 such that the other elongated fasteners can pass through or intersect with the fourth elongated fastener 400. In some embodiments, a transverse dimension of the first elongated fastener 100 is greater than a transverse dimension of the second elongated fastener 200. In some embodiments, a transverse dimension of the first elongated fastener 100 is greater than a transverse dimension of the third elongated fastener 300.
(26) In some embodiments, first axis 411 and the longitudinal axis 401 of the fourth elongated fastener 400 are oblique. In some embodiments, second axis 421 and the longitudinal axis 401 of the fourth elongated fastener 400 are perpendicular. In some embodiments, third axis 431 and the longitudinal axis 401 of the fourth elongated fastener 400 are perpendicular. In some embodiments, second axis 421 and the third axis 431 are skew. In some embodiments, first axis 411 and the second axis 421 are skew. In some embodiments, first axis and the third axis are skew.
(27) Ankle fixation system 10 can be configured such that movement (e.g., axial, angular, lateral and/or torsional movement) of the first, second and/or third elongated fastener 100, 200, 300 relative to fourth elongated fastener 400 is impeded or prevented. For example,
(28) First, second, third and/or fourth elongated fasteners 100, 200, 300, 400 comprises one or more pure or alloyed metals selected from a group consisting of stainless steel, cobalt, chromium, titanium and tantalum.
(29) Fourth elongated fastener 400, as shown in
(30) In some embodiments, ankle fixation system 10 can be configured for polyaxial coupling of the first, second and/or third elongated fastener 100, 200, 300 to the fourth elongated fastener 400, whereby a single fixation system 10 is compatible with a wide range of foot anatomies. More specifically, the first, second and/or third holes 410, 420, 430 of the fourth elongated fastener 400 and the first, second and/or third elongated fastener 100, 200, 300 can be configured in the manner shown in
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(32) The screw 7 has a head 8 and a shank 9. The head 8 is shaped like a partial sphere and is threaded, e.g., helical grooves on the under surface of the head. In some embodiments, the threading can have a pitch that is different than the pitch of the threaded shank 9, if the shank 9 is also threaded. With such a configuration, the screw 7 can be introduced in alignment with the axis X (
(33) In order to lock, in the embodiment shown, the surface defining each hole 5 can have, for example, a small number of isolated protrusions 6 (such as pegs or spikes), which number is within 2 and 30, designed to lock against the threaded spherical head 8 of the screw 7 when the screw is driven through the hole 5. Once the screw 7 has been driven in, it locks tightly against the protrusions 6 on the surface defining the hole 5. Alternatively, in a variation on the embodiment shown, the surface defining each hole 5 is smooth, and when driving the screw through the hole, the threads of the spherical head 8 of the screw 7 can gall the surface of the hole 5, thereby locking the screw relative to the fourth elongated fastener 400.
(34) In another embodiment configured for polyaxial coupling, as shown in
(35) In yet another embodiment configured for polyaxial coupling, as shown in
(36) In some embodiments, the first, second and/or third elongated fastener 100, 200, 300 have a solid body. In other embodiments, the first, second and/or third elongated fastener 100, 200, 300 can be configured for insertion over a guide wire and for receiving a reinforcing member, e.g., a stiff rod, once positioned and the wire removed. For example, as shown in
(37) The cross-sectional shape of the reinforcing member 12 and the longitudinal bore 11 of the first, second, or third elongated member can be configured for isotropic or anisotropic deformation and support during use. The cross-sectional shape shown in
(38) During insertion of the reinforcing member 12, the fourth elongated member 400 is sufficiently immobilized, either directly or through the jig system, to support the counterforce.
(39) In some embodiments, with reference to
(40) Alternatively, as shown in
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(42) Each press comprises members 701, 751, configured for contacting and applying pressure to the foot (e.g., a padded member). Foot contacting member 751 of second press 750 is spaced apart from the foot contacting member 701 of the first press 700 to facilitate shaping the longitudinal arch 52. The foot contacting member 701 of first press 700 is nearer the distal end than foot contacting member 751 of second press 750.
(43) In the embodiment shown, first press 700 comprises a rigid support 710 that is configured to couple in fixed relation to plate 600 and configured to support one or more members 701. Each member 701 is configured to couple with rigid support 710 such that it can move away and towards plate 600, as selected by a clinician, but not from pressure applied by the foot. For example, member 701 can be threadably coupled to rigid support 710 such that rotation of member 701 causes movement towards or away from plate 600.
(44) Rigid support 710 can be configured so that the location of the rigid support 710 relative to the foot supporting member is adjustable. For example, in the embodiment shown, plate 600 comprises one or more slots 610 and rigid support 710 is configured to slide within the slots at one time and couple in fixed relation to plate 600 at another time.
(45) Each of the members 751 of second press 750 can be configured to couple with the foot supporting member (shown as plate 600) such that the members 751 can move away and towards the foot supporting member, as selected by a clinician, but not from pressure applied by foot 50. For example, member 751 can be threadably coupled to plate 600 such that rotation of member 751 causes movement towards or away from plate 600.
(46) In some embodiments, each foot contacting member 701, 751 of each press 700, 750 can be configured such that the selective movement of each member relative to the plate is independent of the other members 701, 751 (if more than one) of that press 700, 750. Second press 750 in particular can comprise a plurality of members 751 located in close proximity to each other underneath the area of the longitudinal arch 52. Second press 750 can comprise at least 5, 10, 15 or more foot contacting members 751 that can be variably adjusted to define a desired contour of the longitudinal arch 52. The members 751 can define a contour that mimics the contour of the longitudinal arch 52 when under the load of walking or standing.
(47) Foot supporting member, such as plate 600, can function as a jig to guide an elongated fastener (e.g., fourth elongated fastener 400 or 500 as described above) into the calcaneus and talus. For example, in the embodiment shown, plate 600 comprises a hole 606 that is configured to receive an elongated fastener (e.g., fourth elongated fastener 400 or 500, as described above) along an axis 607. Hole 606 is located between proximal end 601 and second press 750. When a foot is properly positioned on plate 600, the hindfoot 54 is disposed above hole 606 and the longitudinal arch 52 is positioned above hole 604 or second press 750. When a foot 50 is properly positioned on plate 600, axis 607 intersects with the calcaneus and talus or with the calcaneus, talus and tibia.
(48) To facilitate fixing the position of the foot relative to the foot supporting member, the foot supporting member can comprise one or more holes 616 located between the proximal end 601 and second press 750 and configured so that an elongated fastener (such as pin 617) can be inserted into the calcaneus of foot 50. Plate 600 is shown comprising a plurality of holes 616. The selection of which to use or how many can depend on the foot. Once procedure is completed, pin 617 is removed.
(49) The foot supporting member, such as plate 600, can also comprise at least one alignment marking 620, configured to inform proper alignment of the foot 50 on the foot supporting member and/or proper alignment on the foot supporting member relative to the jig 800 described below. Alignment marking 620 can be linear and define a line that intersects or bisects hole 606. The line can also be coplanar with axis 609 of jig 800 (described below). The foot would be placed on the foot supporting member and aligned with marking 620 so that the first metatarsal of the foot would intersect with axis 609.
(50) Foot securement and jig device 40 can also comprise jig 800, configured to couple in fixed relation to the foot supporting member, e.g., at proximal end 601 of plate 600. Jig 800 comprises a plurality of holes to serve as guides. The plurality of holes of jig 800 are configured to receive an elongated fastener and guide the elongated fastener (e.g., first, second or third elongated fasteners 100, 200, 300, described above) along a desired axis. For example, hole 608 can be configured to receive an elongated fastener (e.g., first elongated fastener 100, described above) along axis 609. Jig 800 can also comprise hole 612 can be configured to receive another elongated fastener (e.g., second elongated fastener 200, described above) along an axis 612. Jig 800 can also comprise hole 614 configured to receive an elongated fastener (e.g., third elongated fastener 200, described above) along an axis 615. When foot 50 is in proper alignment within device 40, axis 609 can intersect with the talus and first metatarsal of foot 50, axis 612 can intersect with the calcaneus and the second cuneiform of foot 50 and/or axis 615 can intersect with the calcaneus and the cuboid of foot 50.
(51) In addition, axis 607 and axis 612 are perpendicular, and axis 607 and axis 609 are oblique. Axis 607 and axis 615 are perpendicular. Axis 615 and axis 612 are skew. Hole 614 is located between the proximal end 601 of the plate 600 and hole 608. Hole 611 is located between the proximal end 601 of the plate 600 and hole 608.
(52) Foot securement and jig device 40 can also comprise two lower leg supporting members 900, 910 configured such that a lower leg 60 is flanked by the two members 900, 910 when a bottom surface of the foot 50 is in contact with the plate 600 or other foot supporting member. Lower leg supporting members 900, 910 are configured to couple in fixed relation to the foot supporting member, e.g., plate 600.
(53) Each lower leg supporting member 900, 910 is configured to couple with a length adjustable pin 950 such that the length adjustable pin will span the distance between the two lower leg support members 900, 910. For example, in the embodiment shown, each lower leg support member 900, 910 comprises a first slot 908 oriented to extend lengthwise along the lower leg support member 900, 910 and configured to receive the length adjustable pin 950 and permit sliding of the length adjustable pin 950 along the length of the first slot 908.
(54) In addition, each lower leg support member 900, 910 can be configured to couple with a fixed length pin such that the fixed length pin will span the distance between the two lower leg support members 900, 910. For example, in the embodiment shown, each lower leg support member 900, 910 comprises a second slot 909 oriented to extend lengthwise along the lower leg support member 900, 910 and configured to receive the fixed length pin 955 and permit sliding of the fixed length pin 955 along the length of the second slot. Second slot 909 is located between the plate 600 and first slot 908. Pins 950 and 955 facilitate positioning and/or securing the tibia to the device 40.
(55) Other embodiments of the present disclosure include methods for shaping a deformed foot using the jig system described above and methods for implanting an internal ankle fixation system into a patient, which can be done after the foot is secured to the jig system.
(56) In an embodiment, a method of implanting an internal ankle fixation system into a patient or reconstructing the foot can comprise inserting the fourth elongated member into a calcaneus, talus, and optionally a tibia of the patient and inserting a first, second, or third elongated member into a talus and at least one of a cuboid, a cuneiform, or a first metatarsal of the patient, whereby the fourth elongated member intersects with the first, second, or third elongated member. In some embodiments, the first elongated member is inserted into talus and the first metatarsal of the patient, the second elongated member is inserted into talus and the cuboid of the patient, and the third elongated member is inserted into talus and the cuneiform of a patient.
(57) Prior to implanting the elongated members, the foot is secured to a jig system as described above. In some embodiments, securing a foot of the patient to a jig system comprises passing a pin through the plate and into the calcaneus of the patient.
(58) In some embodiments, a method of shaping or reshaping the foot can comprise securing a foot of the patient to the jig system and applying pressure to the foot with the first press, the second press, or both. The pressure is sufficient, for example, to shift the positions of the bones within the midfoot and/or forefoot
(59) In some embodiments, a method of shaping or reshaping the foot can comprise securing a foot of the patient to the jig system and applying pressure to the foot with the first press, the second press, or both. The pressure is sufficient, for example, to shift the positions of the bones within the midfoot and/or forefoot
(60) Although embodiments described herein are made with reference to example embodiments, it should be appreciated by those skilled in the art that various modifications are well within the scope and spirit of this disclosure. Those skilled in the art will appreciate that the example embodiments described herein are not limited to any specifically discussed application and that the embodiments described herein are illustrative and not restrictive. From the description of the example embodiments, equivalents of the elements shown therein will suggest themselves to those skilled in the art, and ways of constructing other embodiments using the present disclosure will suggest themselves to practitioners of the art. Therefore, the scope of the example embodiments is not limited herein.