Hybrid Bone Plates and Related Systems and Methods
20220323126 · 2022-10-13
Inventors
Cpc classification
A61B17/8028
HUMAN NECESSITIES
A61B17/80
HUMAN NECESSITIES
B33Y80/00
PERFORMING OPERATIONS; TRANSPORTING
A61L31/14
HUMAN NECESSITIES
A61L31/06
HUMAN NECESSITIES
International classification
A61B17/80
HUMAN NECESSITIES
Abstract
A bone plate includes a main body defining one or more openings and a cavity. A support member formed of a different material than the material of the main body is disposed in the cavity and defines one or more openings, each of which is coaxial with an opening of the main body. The support member extends into circumferential recesses defined by the main body. Circumferential projections bounding each main body opening are disposed between circumferential projections of the main body and are disposed entirely within the support member. Bone plate systems, methods of treatment, and methods of manufacturing are also described.
Claims
1. A bone plate, comprising: a main body formed of a first material and having a first surface and a second surface opposite the first surface, the main body defining a plurality of main body openings, a plurality of main body circumferential walls, and a cavity that is continuous with the plurality of main body openings, each main body circumferential wall bounding a main body opening of the plurality of main body openings and defining a first circumferential recess and a second circumferential recess disposed around each main body opening of the plurality of main body openings; and a support member formed of a second, different material and disposed in the cavity of the main body, the support member defining a plurality of support member openings and a plurality of support member circumferential walls, each support member circumferential wall bounding a support member opening of the plurality of support member openings, a portion of the support member disposed in the first circumferential recess and the second circumferential recess of each main body opening of the plurality of main body openings; wherein each main body opening of the plurality of main body openings is coaxial with a support member opening of the plurality of support member openings to form a passageway partially bounded by a main body circumferential wall of the plurality of main body circumferential walls and a support member circumferential wall of the plurality of support member circumferential walls.
2. The bone plate of claim 1, wherein each passageway has an inner diameter; and wherein a support member circumferential wall of the plurality of support member circumferential walls defines the inner diameter of each passageway.
3. The bone plate of claim 1, wherein the main body defines first and second circumferential projections disposed around each main body opening of the plurality of main body openings.
4. The bone plate of claim 3, wherein each of the first and second circumferential projections are disposed between the first circumferential recess and the second circumferential recess of a main body opening of the plurality of main body openings.
5. The bone plate of claim 4, wherein the first and second circumferential projections disposed around each main body opening of the plurality of main body openings are disposed entirely within the support member.
6. The bone plate of claim 1, wherein the first material comprises a metal.
7. The bone fixation plate of claim 6, wherein the first material comprises one or more of Titanium, Magnesium, Ti6Al4V, 316 LVM, 1.4441Ti-13Nb-13Zr, Ti-12Mo-6Zr-2Fe, Ti-15Mo-5Zr-3Al, Ti-15Mo, Ti-35Nb-7Zr-5Ta and Ti-29Nb-13Ta-4.6Zr Ti-6Al-7Nb and Ti-15Sn-4Nb-2Ta-0.2Pd Co—Cr—Mo alloys.
8. The bone plate of claim 1, wherein the second material comprises a polymeric material.
9. The bone fixation plate of claim 8, wherein the second material comprises one or more of PAEK, CFR PAEK, PEKK, CFR PEKK, PEEK, CFR-PEEK, PEEK (90G, 450G, 12, 14), Polyamid, and PA66.
10. The bone fixation plate of claim 1, wherein the first material comprises a Titanium alloy and the second material comprises PEEK.
11. The bone fixation plate of claim 1, wherein the support member comprises an overmolded structure formed on the main body.
12. A bone plate, comprising: a main body formed of a first material and having a first surface and a second surface opposite the first surface, the main body defining a first main body circumferential wall bounding a first main body opening, a second main body circumferential wall bounding a second main body opening, and a cavity that is continuous with the first and second main body openings; and a support member formed of a second, different material and disposed in the cavity of the main body, the support member defining a first support member circumferential wall bounding a first support member opening that is coaxial with the first main body opening and a second support member circumferential wall bounding a second support member opening that is coaxial with the second main body opening.
13. The bone plate of claim 12, wherein the first main body opening has a first main body inner diameter, the second main body opening has a second main body inner diameter, the first support member opening has a first support member inner diameter that is less than the first main body opening inner diameter, and the second support member opening has a second support member inner diameter that is less than the second main body opening inner diameter.
14. The bone plate of claim 12, wherein the first material comprises a metal.
15. The bone fixation plate of claim 14, wherein the first material comprises one or more of Titanium, Magnesium, Ti6Al4V, 316 LVM, 1.4441Ti-13Nb-13Zr, Ti-12Mo-6Zr-2Fe, Ti-15Mo-5Zr-3Al, Ti-15Mo, Ti-35Nb-7Zr-5Ta and Ti-29Nb-13Ta-4.6Zr Ti-6Al-7Nb and Ti-15Sn-4Nb-2Ta-0.2Pd Co—Cr—Mo alloys.
16. The bone plate of claim 12, wherein the second material comprises a polymeric material.
17. The bone fixation plate of claim 16, wherein the second material comprises one or more of PAEK, CFR PAEK, PEKK, CFR PEKK, PEEK, CFR-PEEK, PEEK (90G, 450G, 12, 14), Polyamid, and PA66.
18. The bone fixation plate of claim 17, wherein the first material comprises a Titanium alloy and the second material comprises PEEK.
19. A bone plate, comprising: a main body comprising a metal and having a first surface and a second surface opposite the first surface, the main body defining a first main body circumferential wall bounding a first main body opening, a second main body circumferential wall bounding a second main body opening, a first and second circumferential recesses disposed around the first main body opening, third and fourth circumferential recesses disposed around the second main body opening, first and second circumferential projections disposed between the first and second circumferential recesses, third and fourth circumferential projections disposed between the third and fourth circumferential recesses, and a cavity that is continuous with the first and second main body openings; and a support member comprising a polymeric material and disposed in the cavity of the main body and the first, second, third, and fourth circumferential recesses, the support member defining a first support member circumferential wall bounding a first support member opening that is coaxial with the first main body opening and a second support member circumferential wall bounding a second support member opening that is coaxial with the second main body opening.
20. The bone fixation plate of claim 19, wherein the first material comprises a Titanium alloy and the second material comprises PEEK.
Description
DESCRIPTION OF FIGURES
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[0020]
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DETAILED DESCRIPTION OF SELECTED EXAMPLES
[0036] The following detailed description and the appended drawings describe and illustrate various example bone plates, bone plate systems, methods of treatment, and methods of manufacturing a bone plate. The description and drawings are provided to enable one skilled in the art to make and use one or more example bone plates and bone plate systems, and to perform one or more example methods of treatment and methods of manufacturing a bone plate. They are not intended to limit the scope of the claims in any manner.
[0037] As used herein, the term “porous,” and grammatically related terms, refers to a macro structural configuration of a component or portion of a component in which the material of the component or portion of a component defines a series of passageways into which material, such as a liquid, can enter. The passageways can be randomly distributed throughout the component or portion of a component, or can be distributed throughout the component or portion of a component in an ordered fashion. As an example, a lattice structure created during 3D printing of a metal component or portion of a metal component provides a porous structure consistent with this definition of “porous.” The term does not include micro structural pores that naturally occur in the material that comprises the component or portion of a component.
[0038] As used herein, the term “non-porous,” and grammatically related terms, refers to a macro structural configuration of a component or portion of a component in which the material of the component or portion of a component does not define a series of passageways into which material, such as a liquid, can enter.
[0039]
[0040] The main body 110 defines a circumferential wall 122a, 122b, 122c, 122d, 122e, 122f, 122g for each passageway 120a, 120b, 120c, 120d, 120e, 120f, 120g of the plurality of passageways 120. Each circumferential wall 122a, 122b, 122c, 122d, 122e, 122f, 122g bounds a respective passageway 120a, 120b, 120c, 120d, 120e, 120f, 120g.
[0041] The main body 110 includes a non-porous portion 130 and a porous portion 150. In the illustrated example, the non-porous portion 130 is a continuous portion of the main body 110, while the porous portion 150 comprises a plurality of discrete porous portions 150a, 150b, 150c, 150d, 150e, 150f, 150g. Each circumferential wall 122a, 122b, 122c, 122d, 122e, 122f, 122g is cooperatively formed by the non-porous portion 130 and one of the discrete porous portions 150a, 150b, 150c, 150d, 150e, 150f, 150g. As best illustrated in
[0042] This structural configuration of the circumferential wall 122g is considered advantageous at least because it positions the porous portion 150g of the circumferential wall 122g beneath the non-porous portion 130 of the circumferential wall 122g with respect to the opposing surfaces 116, 118. As best illustrated in
[0043] In the illustrated example, each circumferential wall 122a, 122b, 122c, 122d, 122e, 122f, 122g has a similar structure to that described above for circumferential wall 122g, with porous portion 150a, 150b, 150c, 150d, 150e, 150f, 150g beneath the non-porous portion 130 with respect to the opposing surfaces 116, 118. It is noted, though, that bone plates according to other examples can include circumferential walls having different structures. For example, it may be desirable to include one or more circumferential walls having a thread that is fully formed by the non-porous portion of a bone plate according to an embodiment in addition to a circumferential wall having the structural configuration described above. Inclusion of such a circumferential ensures that at least one thread is available that does not require thread forming action by a screw during placement of the bone plate, which may be desirable. Inclusion of at least one circumferential wall having the structural configuration described and illustrated above is considered advantageous at least because it ensures that at least one screw will be installed with thread forming action, providing desirable securement and bony ingrowth properties for the bone plate.
[0044] A bone plate according to an embodiment can include any suitable number of passageways. A skilled artisan will be able to select an appropriate number of passageways for a bone plate according to a particular embodiment based on various considerations, including the anatomical location at which the bone plate is intended to be used. The inclusion of seven passageways in the bone plate 100 illustrated in
[0045] The porous portion in a bone plate according to a particular embodiment can have any suitable dimensions, and a skilled artisan will be able to select appropriate dimensions for a porous portion in a bone plate according to a particular embodiment based on various considerations, including the function of the porous portion. For example, in embodiments in which the porous portion forms a portion of the circumferential wall bounding a screw passageway and is to deform in response to a screw being driven through the passageway, the inventors have determined that a porous portion having a thickness of between about 1 mm and 2 mm is suitable for a passageway having an inner diameter of 4 mm. In embodiments in which the porous portion forms a boundary for a cavity into which a support member is to be formed, such as by injection molding, the inventors have determined that a porous portion having a thickness of between about 0.5 mm and 1 mm is suitable.
[0046]
[0047] The main body 210 defines a circumferential wall 222a, 222b, 222c for each passageway 220a, 220b, 220c of the plurality of passageways 220. Each circumferential wall 222a, 222b, 222c bounds a respective passageway 220a, 220b, 220c.
[0048] The main body 210 includes a non-porous portion 230 and a porous portion 250. The non-porous portion 230 is a continuous portion of the main body 210. In this example, and in contrast to first example bone plate 100, porous portion 250 is also a continuous portion of the main body 210. Each circumferential wall 222a, 222b, 222c is cooperatively formed by the non-porous portion 230 and the porous portion 250. Each circumferential wall 222a, 222b, 222c is recessed within a respective passageway 220a, 220b, 220c, providing a countersink structure for a bone screw. Non-porous portion 230 of the main body 210 defines the upper portion 224a, 224b, 224c of each circumferential wall 222a, 222b, 222c, while porous portion 250 defines the lower portion 226a, 226b, 226c of each circumferential wall 222a, 222b, 222c. The lower portion 226a, 226b, 226c of each circumferential wall 222a, 222b, 222c is continuous and flush with the lower surface 218 of the main body 210. Lower surface 218 is cooperatively formed by the non-porous portion 230 and the porous portion 250. In this example, non-porous portion 230 forms a perimeter edge 255 of the lower surface 218.
[0049] This structural configuration is considered advantageous at least because it provides the desirable thread forming capability of the porous portion 250 in the passageways while also positioning the porous portion 250 on the majority of the lower surface 218 of the main body 210, which is the bone-contacting surface of the bone plate 200. The porous structure of the porous portion 250 provides structure that is advantageous for bony ingrowth following securement of the bone plate 200 to a bone. Taken together, the thread forming capability provided by the porous portion 250 positioned within the passageways 220a, 220b, 220c and the advantageous bony ingrowth structure provided by the porous portion positioned on the majority of the lower surface 218, the porous portion 250 provides desirable securement properties for the bone plate 200.
[0050] The porous portion can comprise any suitable portion of the lower surface in a bone plate according to a particular embodiment, and a skilled artisan will be able to select a suitable portion, based on percentage of total surface area of the lower surface, for a bone plate according to a specific embodiment based on various considerations, including the anatomical location at which the bone plate is intended to be used. Examples of suitable percentages of total surface area of the lower surface that the porous portion comprises include, but are not limited to, at least about 50% of the total surface area of the lower surface, greater than 50% of the total surface area of the lower surface, between about 60% and about 90% of the total surface area of the lower surface, between about 70% and about 90% of the total surface area of the lower surface, between about 80% and about 90% of the total surface area of the lower surface, and between about 85% and about 90% of the total surface area of the lower surface.
[0051] While the bone plate illustrated in
[0052]
[0053] Main body 310 has a first end 312, a second end 314, and a lengthwise axis 301 extending between the first end 312 and the second end 314. The main body 310 has first 316 and second 318 opposing surfaces. The main body 310 and support member 390 cooperatively define a plurality of passageways 320. Each passageway 320a, 320b, 320c of the plurality of passageways 320 extends through the entire thickness of the bone plate 300, from the first surface 316 to the second surface 318. As such, each passageway 320a, 320b, 320c provides a through opening within which another component can be disposed, such as a bone screw useful in securing the bone plate 300 across a fracture in a bone as part of a fixation procedure.
[0054] The main body 310 and support member 390 cooperatively define a circumferential wall 322a, 322b, 322c for each passageway 320a, 320b, 320c of the plurality of passageways 320. Each circumferential wall 322a, 322b, 322c bounds a respective passageway 320a, 320b, 320c.
[0055] The main body 310 includes a non-porous portion 330 and a porous portion 350. The non-porous portion 330 is a continuous portion of the main body 310 while the porous portion 350 comprises a plurality of discrete porous portions 350a, 350b, 350c. Each circumferential wall 322a, 322b, 322c is cooperatively formed by the non-porous portion 330, one of the discrete porous portions 350a, 350b, 350c, and the support member 390. Each circumferential wall 322a, 322b, 322c is recessed within a respective passageway 320a, 320b, 320c, providing a countersink structure for a bone screw. Non-porous portion 330 of the main body 310 defines the upper portion 324 of each circumferential wall 322c, while the support member 390 defines the lower portion 326 of the circumferential wall 322c. Porous portion 350c provides an intermediate 328c portion of the circumferential wall 322a. In this example, lower surface 318 is cooperatively formed by the non-porous portion 330 of the main body 310, the porous portions 350a, 350b, 350c of the main body 310, and the support member 390.
[0056] In this example, the porous portion 350 provides boundaries for the cavity 360 of the main body 310. This is particularly advantageous for bone plates in which the support member is formed by injection molding, as the porous portion 350 permits polymer to enter the passageways of the porous portion, enhancing fixation between the main body 310 and support member 390. Furthermore, positioning of the porous portion 350 in the circumferential walls 322a, 322b, 322c also provides the thread forming capability described above, providing additional advantage to this structural configuration.
[0057] Alternatively, as illustrated in
[0058]
[0059] In this embodiment, main body 410 defines an upper circumferential recess and a lower circumferential recess around each passageway 420a, 420b, 420c, 420d, 420e, 420f of the plurality of passageways 420.
[0060] In the illustrated example, the upper circumferential recess 442c extends radially inward from the central axis of the passageway 420c and generally in an upward direction toward the upper surface 416 of the main body 410. The lower circumferential recess 444c also extends radially inward from the central axis of the passageway 420c and generally in an upward direction toward the upper surface 416 of the main body 410. The lower circumferential recess 444c extends further radially inward relative to the central axis of the passageway 420c than the upper circumferential recess 442c.
[0061] Main body 410 defines first 446c and second 448c circumferential projections that are disposed between the upper circumferential recess 442c and lower circumferential recess 444c. In this example, first and second projections that are identical to first 446c and second 448c projections are disposed around each of the other passageways 420a, 420b, 420d, 420e, 420f defined by the main body 410, but are not visible in the drawings. As best illustrated in
[0062] As indicated above, support member 490 defines a circumferential wall 422a, 422b, 422c, 422d, 422e, 422f for each passageway 420a, 420b, 420c, 420d, 420e, 420f of the plurality of passageways 420. As best illustrated in
[0063] It is noted that, while not illustrated in
[0064] The porous portion in a bone plate according to a particular embodiment can have any suitable dimensions, and a skilled artisan will be able to select appropriate dimensions for a porous portion in a bone plate according to a particular embodiment based on various considerations, including the function of the porous portion. For example, in embodiments in which the porous portion forms a portion of the circumferential wall bounding a screw passageway and is to deform in response to a screw being driven through the passageway, the inventors have determined that a porous portion having a thickness of between about 1 mm and 2 mm is suitable for a passageway having an inner diameter of 4 mm. In embodiments in which the porous portion forms a boundary for a cavity into which a support member is to be formed, such as by injection molding, the inventors have determined that a porous portion having a thickness of between about 0.5 mm and 1 mm is suitable.
[0065] Bone plates according to embodiments can be made from any material suitable for use in medical devices intended for orthopedic use, including use as a long-term implant. Examples of suitable materials include metals, metal alloys, and polymeric materials. Inclusion of a porous portion is critical to achieving the desired properties of the inventive bone plates. Accordingly, use of a material that enables formation of a porous portion using appropriate techniques is appropriate. Examples of suitable materials for which appropriate porous portions can be formed using conventional techniques, such as 3D printing, include, but are not limited to, Titanium, Magnesium, and other suitable materials. Examples of suitable metal alloys include stainless steel (316L), cobalt alloys, pure titanium, titanium alloys, magnesium alloys, molybdenum alloys, zirconium alloys, Ti6Al4V, 316 LVM, 1.4441Ti-13Nb-13Zr, Ti-12Mo-6Zr-2Fe, Ti-15Mo-5Zr-3Al, Ti15Mo, Ti-35Nb-7Zr-5Ta and Ti-29Nb-13Ta-4.6Zr Ti-6Al-7Nb and Ti-15Sn-4Nb-2Ta-0.2Pd Co—Cr—Mo alloys.
[0066] Non-metal materials are also considered suitable for use in bone plates according to embodiments, both as a main body component and, if included, as a support member component. Examples of suitable non-metal materials include polymeric materials, including plastic metals currently considered suitable for use in medical devices, carbon fiber, polyaryletherketone (PAEK), polyether ether ketone (PEEK), PEEK (90G, 450G, 12, 14), Polyamid, PA66, carbon fiber reinforced polyaryletherketone (CFR PAEK), polyethere ketone ketone (PEKK), carbon fiber reinforced polyether ketone ketone (CFR PEKK), carbon fiber reinforced polyether ether ketone (CFR PEEK), CFR PEEK (90G CA30, 90G CA20, 450G CA30, 450G CA20, 12 CF20, 12 CF30, 14 CF30, 14 CF20), Polyamid CFR, PA66 CFR, and any other materials considered suitable for a bone plate. The inventors have determined that, for embodiments in which the support member includes carbon fiber, it is considered advantageous to include carbon fiber in the material of the support member at an amount that represents a balance between the desirable strength carbon fiber provides and any offsets it contributes to the contourability of the bone plate due to the brittleness of the material. For plates that include a support member comprising carbon fiber reinforced polyether ether ketone (CFR PEEK), it is considered advantageous to include carbon fiber in PEEK at an amount that is less than 5% on a volume basis. It is also considered advantageous to include carbon fiber in PEEK at an amount that is less than 2.5% on a volume basis. It is also considered advantageous to include carbon fiber in PEEK at an amount that is less than 1% on a volume basis. It is also considered advantageous to include carbon fiber in PEEK at an amount that is less than 0.1% on a volume basis. It is also considered advantageous to include carbon fiber in PEEK at an amount that is less than 0.01% on a volume basis.
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[0070]
[0071] A second step 812 comprises disposing a support member in the cavity of the bone plate precursor to form a bone plate intermediate that includes a main body that defines a plurality of passageways, each of which is blocked by a sacrificial wall, and a cavity, and a support member disposed within the cavity such that the support member abuts each of the sacrificial walls.
[0072] A third step 814 comprises removing the sacrificial wall associated with each passageway of the plurality of passageways in the bone plate intermediate to form final passageways that extend through the main body and the support member. In one example, this step 814 is accomplished by drilling through the sacrificial wall and the support member in a bone plate intermediate, such as bone plate intermediate 1000.
[0073] The foregoing detailed description refers to various example bone plates, bone plate systems, methods of treatment, and methods of manufacturing a bone plate. The description and appended drawings illustrating the described bone plates, bone plate systems, methods of treatment, and methods of manufacturing a bone plate are intended only to provide examples and not to limit the scope of the claims in any manner.