Patent Grant
11160664
The present technology is generally related to devices and methods for arthroplasty procedures. In particular, several embodiments of the present technology are directed to devices and methods for arthroplasty of the metatarsophalangeal joint.
Osteoarthritis (“OA”), particularly OA in the main joint of the great toe (i.e., the first metatarsophalangeal joint (“MTPJ1”), is a significant public health problem. According to one study, by 60 years of age radiographically-confirmed MTPJ1 OA is present in approximately 46% of women and 32% of men. Typical presentations include hallux rigidus or hallux limitus with a painful joint, hallux-sesamoid arthritis, hallux valgus, and inflammatory arthritis. Pathology of this small joint can have a major effect on quality of life because patient mobility is compromised by pain and lack of motion.
The present disclosure relates generally to devices and methods for arthroplasty of a metatarsophalangeal joint. In particular, the disclosed technology is directed to devices and associated techniques for use during an arthroplasty procedure of the metatarsophalangeal joint. As noted above, osteoarthritis (OA), particularly in the main joint of the great toe (the first metatarsophalangeal joint (MTPJ1)) is a challenging joint to treat. The goals of treatment for OA of the MTPJ1 are to reduce pain and restore mobility of the MTPJ1. When conservative treatment has failed, the two most common surgical options for treatment of OA are removal of damaged articular cartilage and bone (cheilectomy) and, for more severe cases, complete fixation of the joint with trans-articular screws or plates (arthrodesis). Neither of these approaches have high rates of patient satisfaction—particularly among women, who find footwear choices limited after the main toe joint is fixed.
The MTPJ1 is also a challenging joint to replace. The presently available devices to replace all or part of MTPJ1 can be classified into three groups: (1) Single hemi-arthroplasty (e.g., a Futura™ metal hemi toe device); (2) Unconstrained modular arthroplasty for both joint components (e.g., a Medin™ MTP Toe Joint replacement device); or (3) Flexible hinge joints (e.g., a Swanson™ Flexible Hinge Toe). None of these devices, however, have received widespread acceptance from the foot and ankle surgical community; arthrodesis remains the treatment of choice for most surgeons.
Further challenges with replacing the MTPJ1 often arise because there is typically insufficient bone available for fixation using conventional methods, and the loads on the joint are large. At least one study indicates that the median failure/complication rate is 15%, but the upper end of the range is an alarming 93%. In a recent systematic review of outcomes, one author concluded that: “arthrodesis achieves better functional outcomes than total joint replacement” and that “advances still need to be achieved to produce a more successful and anatomical prosthesis that could be functionally superior to an arthrodesis.” Brewster, Mark. “Does total joint replacement or arthrodesis of the first metatarsophalangeal joint yield better functional results? A systematic review of the literature.” The Journal of Foot and Ankle Surgery 49.6 (2010): 546-552.
An examination of the failure patterns in conventional MTPJ1 joint replacements shows that the most common reported causes of failure are loosening, misalignment, or migration. This is not surprising when the usual techniques of fixation are considered—the components are press- or screw-fitted into the medullary cavity of at least one bone abutting the joint of interest, with or without a polyethylene insert, after reaming of the bone.
Devices configured in accordance with the present technology for use during an arthroplasty procedure of a metatarsophalangeal joint of a patient are expected to address the shortcomings of conventional devices. In one embodiment, for example, a device for use during an arthroplasty procedure of a metatarsophalangeal joint includes an (i) end plate coupled configured and arranged for disposing over a first joint end of a first bone, (ii) a longitudinal plate coupled to the end plate and configured and arranged for disposing along a medial, longitudinal surface of the first bone, and (iii) a stem coupled to the end plate and suitable for extending along an intra-medullary canal of the first bone. At least one fastener couples the longitudinal plate to the stem, the at least one fastener extending at least partially through a longitudinal surface of the first bone.
Further embodiments of the present technology are also directed to methods of performing an arthroplasty procedure on a joint of a human patient. One method can include, for example, removing a portion of a first joint end of a first bone and coupling an implant to the first joint end of the first bone. The implant is coupled such that (a) a stem of the implant is disposed within an intra-medullary canal of the first bone, (b) an end plate of the implant is disposed over the first joint end of the first bone, and (c) a longitudinal plate of the implant is disposed along a medial, longitudinal surface of the first bone. The method can further include extending a fastener between the longitudinal plate and the stem, with the fastener passing through the longitudinal surface of the first bone.
Further specific details of several embodiments of the present technology are described below with reference to
For ease of reference, throughout this disclosure identical reference numbers are used to identify similar or analogous components or features, but the use of the same reference number does not imply that the parts should be construed to be identical. Indeed, in many examples described herein, the identically numbered parts are distinct in structure and/or function.
As used herein, the terms “distal” and “proximal” refer to the location of the referenced element with respect to the tarsal bones of the patient's foot near the ankle. “Proximal” refers to a location closer to the tarsal bones/ankle, and “distal” refers to a location farther away from the tarsal bones/ankle toward the phalanges (the bones of the toes).
Selected Embodiments of Devices and Methods for Arthroplasty Procedures
The first arthroplasty device 101 includes an end plate 103 disposed over the distal end region 193 of the metatarsal bone 195. A longitudinal plate 105 extends from the end plate 103 proximally away from the end plate 103 along a medial surface of the metatarsal bone 195. A stem 107 (shown in broken lines) also extends proximally from the end plate 103 along the intramedullary canal of the metatarsal bone 195. Fasteners 109a and 109b (shown in broken lines) can be inserted through holes (
The second arthroplasty device 151 can be configured similarly to the first arthroplasty device 101. For example, the second arthroplasty device 151 includes an end plate 153 disposed over the proximal end region 197 of the proximal phalanx bone 199. The end plate 153 of the second arthroplasty device 151 is configured to engage with the end plate 103 of the first arthroplasty device 101. A longitudinal plate 155 extends distally away from the end plate 153 along a medial surface of the proximal phalanx bone 199. A stem 157 extends distally from the end plate 153 along the intramedullary canal of the proximal phalanx bone 199. Fasteners 159a and 159b (shown in broken lines) extend through the longitudinal plate 155 and the stem 157 and couple the longitudinal plate 155 to the proximal phalanx bone 199. For example, the fasteners 159a and 159b can be inserted through holes (not shown) in the longitudinal plate 155 and the stem 157 and gain purchase in the lateral cortex of the proximal phalanx bone 199.
The surfaces of the end plates 103 and 153 are complementary to allow for the surfaces to mate with one another while allowing the two to articulate with respect to one another. In some embodiments, for example, the surface of the end plate 103 of the first arthroplasty device 101 is convex and the surface of the end plate 153 of the second arthroplasty device 151 is concave. In other embodiments, however, the shapes of the end surfaces can be reversed (i.e., the surface of end plate 103 may be concave and surface of end plate 153 may be convex). In another embodiment, the surface of the end plate 103 of the first arthroplasty device 101 has a shape corresponding to the natural shape of the metatarsal bone 195 and the surface of the end plate 153 of the second arthroplasty device 151 has a shape corresponding to the natural shape of the proximal phalanx bone 199. In some embodiments, the complementary shapes for the articular surfaces may be patient-specific surfaces based on previously obtained information from a CT scan or other imaging technique. While such personalization may be attractive in some cases, in other embodiments generic articular surface shapes over an anticipated size range are used.
It will be appreciated that although
The longitudinal plate 105 includes one or more holes or apertures 110 (two are shown) for receiving fastener(s), such as fasteners 109a-b, to secure the first arthroplasty device 101 in place relative to the bone 195. The stem 107 can also include one or more corresponding holes or apertures 111 aligned with the holes 110 to receive the fastener(s) and allow the fastener(s) to pass through to obtain purchase in the opposite bone cortex. In some embodiments, the holes 111 in the stem 107 may be oversized relative to the holes 110 and fasteners 109a-b. Although the holes 110 are shown with a raised profile in the illustrated embodiment, in other embodiments the holes 110 may be countersunk relative to the surface of the longitudinal plate 105 such that when the fasteners 109a-b are installed therethrough, the fastener heads are flush with the surface of the longitudinal plate 105.
As best seen in
Guide hole(s) 206 for fastener insertion may also be formed in the metatarsal bone 195 substantially perpendicular to the long axis of the bone 195, and configured to intersect with the void 204. In the illustrated embodiment, two guide holes 206 have been formed and shaped/sized to correspond to holes 110 when the first arthroplasty device 101 is installed.
During installation, the first arthroplasty device 101 is mated with the prepared metatarsal bone 195. In at least some embodiments, the first arthroplasty device 101 may tapped into place. When the first arthroplasty device 101 in in place relative to the bone 195, the fasteners 109a and 109b are inserted through the holes 110 in the longitudinal plate 105 and through the guide holes 206 in the metatarsal bone 195. As best seen in
One feature of the first arthroplasty device 101 is that, when installed, the stem 107 and longitudinal plate 105 are coupled together via at least one fastener 109. This feature is expected to reduce or inhibit the problems experienced by many conventional devices associated with loosening, misalignment, and/or migration of the implant. Further, because the fasteners 109a-b gain purchase though a relatively significant portion of the bone 195, the first arthroplasty device 101 is expected to be able to handle the large loads on the MTPJ1 joint with less complications/failures than conventional devices.
The longitudinal plate 155 includes one or more holes or apertures 158 (two are shown) for receiving fastener(s), such as fasteners 159a-b, to secure the second arthroplasty device 151 in place relative to the bone 199 (
As best seen in
As with the first arthroplasty device 101 described above, the fasteners 159a and 159b gain purchase in the lateral cortex of the proximal phalanx bone 199 and help reduce/inhibit loosening, misalignment, and/or migration of the device after implantation.
Selected Embodiments of Dual-Component Devices and Methods for Arthroplasty Procedures
The arthroplasty devices described above with respect to
Embodiments of arthroplasty devices described below with respect to
The first component 501 includes an attachment fitting 507 and a stem 509 extending away from the attachment fitting 507. The second component 503 includes an end plate 511 and a longitudinal plate 513 extending away from the end plate 511. In the coupled configuration, the attachment fitting 507 is slidably mated with a recess 515 within the end plate 511. In the illustrated embodiment, the attachment fitting 507 has a generally trapezoidal prism shape, and the recess 515 has a corresponding shape sized and configured to receive the attachment fitting 507 therein. This configuration can provide a mortise and tenon joint in which the attachment fitting is the mortise and the end plate with the recess is the tenon. In some embodiments, the mortise and tenon joint can taper. In other embodiments, the shape and dimensions of the attachment fitting 507 and the recess 515 can take a variety of forms, for example the attachment fitting 507 can be a protrusion having a rectangular, elliptical, circular, irregular polygonal, or any other cross-sectional shape, and the recess 515 can assume a corresponding shape configured to slidably receive the attachment fitting 507 therein. Although the illustrated embodiment facilitates sliding engagement of the attachment fitting 507 and the recess 515, in other embodiments the mating can be a snap-fit, rotatable coupling, or any other configuration that permits removable mating of the attachment fitting 507 and the recess 515.
The stem 509 can have a tapered profile such that a proximal portion closest to the attachment fitting 507 has a larger cross-sectional dimension than a distal portion furthest from the attachment fitting 507. This tapered profile can facilitate insertion of the stem 509 within a prepared intramedullary canal of a target bone. In the illustrated embodiment, for example, the stem 509 has a tiered profile that includes three sections 516a-c having distinct cross-sectional sizes. The first section 516a is directly adjacent to the attachment fitting 507 and has the largest cross-sectional dimension. The second section 516b adjacent to the first section 516a has a smaller cross-sectional dimension than the first section 516a, and the third and distalmost section 516c has a yet smaller cross-sectional dimension, so that the overall profile of the stem 509 tapers inwardly as it extends way from the attachment fitting 507. In the illustrated embodiment, each section 516a-c has a substantially uniform cross-sectional dimension. However, in other embodiments, each section can itself taper or have any other non-uniform cross-sectional dimension, with defined steps disposed between adjacent sections. In some embodiments, the number of sections of the tiered stem 509 can vary, for example two, three, four, five, or more discrete sections. This tiered profile can provide improved purchase of the stem 509 with respect to the intramedullary canal of the target bone, and can facilitate tapping the stem 509 into position.
As described in more detail below with respect to
The end plate 511 of the second component 503 can include a hole or aperture 517 therein that intersects with the recess 515, and the attachment fitting 507 can include a corresponding hole or aperture 519 configured to align with the hole 517 of the end plate 511 when the attachment fitting 507 is received within the recess 515. In use, the first component 501 can be coupled to the second component 503 by sliding the end plate 511 over the attachment fitting 507 such that the attachment fitting 507 is fully received within the recess 515. Once in position, a fastener 518 can be inserted through both the hole 517 in the end plate 511 and through the hole 519 in the attachment fitting 507. This fastener serves to lock the attachment fitting 507 and the end plate 511 together, thereby preventing sliding movement and decoupling of the first component 501 and the second component 503 after implantation. In some embodiments, an additional fixation mechanism can be employed. The additional fixation mechanism can include, for example, an adhesive disposed in or around the recess 515 and/or the attachment fitting 507 or another suitable fixation mechanism.
The longitudinal plate 513 can have a contoured shape configured to be flush with an outer surface of the target bone after implantation of the device 500. In the illustrated embodiment, the longitudinal plate 513 has a length that extends beyond the length of the stem 509. Additionally, the longitudinal plate 513 tapers inwardly towards the stem 509 when the first component 501 and the second component 503 are coupled together. This tapering can provide a better correspondence between the longitudinal plate 513 and the outer surface (e.g., the medial aspect) of the target bone, which can enable the increased length of the longitudinal plate 513 as compared to embodiments in which the longitudinal plate is parallel to the stem.
Similar to the embodiments described above with respect to
The component 601 includes an end plate 603 and a longitudinal plate 605 extending away from the end plate 603. The end plate 603 includes a recess 607 formed therein. The recess 607 can be sized and configured to removably receive a corresponding attachment fitting therein. In the illustrated embodiment, the recess 607 is sized to receive an attachment fitting having a generally trapezoidal prism shape, though the shape and dimensions of the recess 607 can vary in other embodiments. The end plate 603 can include a hole or aperture 609 therein that intersects with the recess 607. As described above with respect to
The longitudinal plate 605 includes a plurality of holes or apertures 611a-b (collectively “holes 611”) for receiving fasteners (not shown) therethrough. Inserting fasteners through the holes 611 secures the component 601 to the bone. Additionally, when used with a corresponding component having a stem with aligned holes therein, the fasteners can be inserted through the holes 611 in the longitudinal plate 605 and through holes in the stem to secure the components together. In the illustrated embodiment, the longitudinal plate 605 is shorter than that of
As described above with respect to
The arthroplasty devices 101/151/401/500/600/800, including the fasteners 109/159 and other referenced fasteners described herein, can be made of a variety of materials including, for example, biocompatible materials such as stainless steel, titanium, and other biocompatible and rigid materials suitable for use in surgical implants.
Further, although the description above refers to the MTPJ1 joint for illustrative purposes, embodiments of the first and second arthroplasty devices and described herein can be suitable for use along any suitable patient joint, for example other metatarsophalangeal joints of the foot, metacarpophalangeal joints of the hand, and any other suitable joint. Moreover, it will be appreciated that the disclosed arthroplasty devices can be modified in many different ways to better accommodate different joints and different anatomies within individual patients. Additionally, although the longitudinal plate is shown on the medial side in the embodiments describe above with reference to
1. A device for use during an arthroplasty procedure of a joint of a patient, the joint extending between a first joint end of a first bone and an abutting second joint end of a second bone of the patient, the device comprising:
2. The device of example 1 wherein:
3. The device of example 1 wherein:
4. The device of any one of examples 1-3, further comprising a first hole in the longitudinal plate and a second hole in the stem, wherein, when the device is installed, the fastener extends through the first and second holes.
5. The device of example 4, further comprising:
6. The device of any one of examples 1-5 wherein the fastener is a locking screw.
7. The device of any one of examples 1-6, further comprising a second longitudinal plate coupled to the end plate and configured and arranged for disposing along the medial, longitudinal surface of the first bone circumferentially opposite to the first longitudinal plate along the medial, longitudinal surface of the first bone, and wherein, when the device is installed, the fastener couples the first and second longitudinal plates to the first bone.
8. The device of any one of examples 1-7 wherein end plate, the longitudinal plate, and the stem comprise at least one of titanium or stainless steel.
9. The device of any one of examples 1-8 wherein the end plate, the longitudinal plate, and the stem are integrally formed.
10. The device of any one of examples 1-9 wherein the stem is tapered.
11. A device for use during an arthroplasty procedure of a joint of a patient, the joint extending between a first joint end of a first bone and an abutting second joint end of a second bone of the patient, the device comprising:
an end plate configured to be disposed over the first joint end of the first bone;
a longitudinal plate extending from the end plate and configured to be disposed along a medial, longitudinal surface of the metatarsus bone, the longitudinal plate having a hole formed therein; and
a stem extending from the end plate and suitable for extending along an intra-medullary canal of the first bone, the stem having a second hole formed therein, and wherein the first hole and the second hole are aligned.
12. The device of example 11, further comprising a fastener for coupling the longitudinal plate to the first bone, and wherein, when the device is installed, the fastener extends through the first hole and the second hole, passing at least partially through the longitudinal surface of the first bone.
13. The device of example 11 wherein:
14. The device of example 11 wherein:
15. A method of performing an arthroplasty procedure on a joint of a human patient, the joint extending between a first joint end of a first bone and an abutting second joint end of a second bone of the patient, the method comprising:
16. The method of example 15, further comprising reaming the intra-medullary canal of the first bone prior to coupling the implant to the first joint end of the first bone.
17. The method of example 15 or example 16 wherein removing the portion of the first joint end of the first bone comprises cutting the portion of the first joint end of the first bone using a surgical template.
18. The method of example 15 wherein the joint is a metatarsophalangeal joint, the first bone is a metatarsus bone, and the second bone is an abutting proximal phalanx bone.
19. The method of example 15 wherein the joint is a metatarsophalangeal joint, the first bone is a proximal phalanx bone of a foot, and the second bone is an abutting metatarsal bone.
20. The method of any one of examples 15-19, further comprising:
21. A device for use during an arthroplasty procedure of a joint of a patient, the joint extending between a first joint end of a first bone and an abutting second joint end of a second bone of the patient, the device comprising:
22. The device of example 21 wherein the attachment fitting comprises a protrusion configured to be received within a recess in the end plate.
23. The device of any one of examples 21-22 wherein the end plate is slidable over the attachment fitting.
24. The device of any one of examples 21-23 wherein, when the attachment fitting and the end plate are mated together, the longitudinal plate converges towards the stem as it extends away from the end plate.
25. The device of any one of examples 21-24 wherein, when the attachment fitting and the end plate are mated together, the longitudinal plate extends further in a longitudinal direction than the stem.
26. The device of any one of examples 21-25 wherein the end plate comprises a first hole and the attachment fitting comprises a second hole configured such that when the attachment fitting and the end plate are mated together, the first hole and the second hole are substantially aligned.
27. The device of example 26, further comprising a second fastener configured to be inserted into both the first hole and the second hole to secure the attachment fitting and the end plate together.
28. The device of any one of examples 21-27, further comprising:
29. The device of example 28, further comprising a fifth hole in the longitudinal plate; and a third fastener configured to extend through the fifth hole and into the first bone without passing through the stem.
30. The device of any one of examples 21-29 wherein the stem is tiered such that a first portion of the stem nearest to the attachment fitting has a larger cross-sectional dimension than a second portion of the stem.
31. A device for use during an arthroplasty procedure of a joint of a patient, the joint extending between a first joint end of a first bone and an abutting second joint end of a second bone of the patient, the device comprising:
32. The device of example 31, further comprising a fastener for coupling the longitudinal plate to the first bone, and wherein, when the device is installed, the fastener extends through the first hole and the second hole, passing at least partially through the longitudinal surface of the first bone.
33. The device of any one of examples 31-32 wherein:
34. The device of any one of examples 31-32 wherein:
35. A method of performing an arthroplasty procedure on a joint of a human patient, the joint extending between a first joint end of a first bone and an abutting second joint end of a second bone of the patient, the method comprising:
36. The method of example 35 wherein coupling the second component of the implant to the first component comprises slidably mating the end plate of the second component to the attachment fitting of the first component.
37. The method of example 36 wherein coupling the second component of the implant to the first component further comprises extending a second fastener through the end plate and the attachment fitting.
38. The method of any one of examples 35-37 wherein the joint is a metatarsophalangeal joint, the first bone is a metatarsus bone, and the second bone is an abutting proximal phalanx bone.
39. The method of any one of examples 35-37 wherein the joint is a metatarsophalangeal joint, the first bone is a proximal phalanx bone of a foot, and the second bone is an abutting metatarsal bone.
40. The method of any one of examples 35-39, further comprising:
The above detailed descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
From the foregoing, it will be appreciated that specific embodiments of the invention have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
This invention was made with government support under Grant No. R21 AR069283, awarded by the National Institutes of Health. The government has certain rights in the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/043639 | 7/25/2017 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
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| WO2019/022712 | 1/31/2019 | WO | A |
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| Number | Date | Country | |
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| 20200197188 A1 | Jun 2020 | US |
