WO2024047399A1 - Distal tibial osteotomy system - Google Patents

Distal tibial osteotomy system Download PDF

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Publication number
WO2024047399A1
WO2024047399A1 PCT/IB2023/000522 IB2023000522W WO2024047399A1 WO 2024047399 A1 WO2024047399 A1 WO 2024047399A1 IB 2023000522 W IB2023000522 W IB 2023000522W WO 2024047399 A1 WO2024047399 A1 WO 2024047399A1
Authority
WO
WIPO (PCT)
Prior art keywords
osteotomy system
distal
tibia
nail
length
Prior art date
Application number
PCT/IB2023/000522
Other languages
French (fr)
Inventor
Robert Flavin
Original Assignee
Rlfa Consultants Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rlfa Consultants Ltd filed Critical Rlfa Consultants Ltd
Publication of WO2024047399A1 publication Critical patent/WO2024047399A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary pins, nails or other devices
    • A61B17/7283Intramedullary pins, nails or other devices with special cross-section of the nail

Definitions

  • the invention relates to a nail for implantation into a tibia to aid in performing an osteotomy or fracture fixation.
  • Tibial fractures often require the use of plates to repair the fracture. Such repairs often lead to poor fusion with non-union of the bone portions and loss of fixation.
  • the present invention is a distal tibia osteotomy system that includes a nail having an elongate body.
  • the body has an oblong cross section and an arcuate length.
  • a plurality of fixation are provided for insertion into the nail.
  • FIG. 1 is a side elevational view of a distal tibial osteotomy system according to an exemplary embodiment of the present invention implanted in a tibia;
  • FIG. 1A is a side elevational view of a distal tibial osteotomy nail according to an alternative exemplary embodiment of the present invention
  • FIG. 2 is a front elevational view of the system and tibia of FIG. 1
  • FIG. 3 is an enlarged view of the system and tibia of FIG. 1, taken along circle 3 of FIG. 1.
  • Provisional Patent Application Serial No. 63/402,967 entitled “Repair Plate System from Inside/Out” ), filed on this date and invented by this inventor (Attorney Docket No. TYB-059); U.S. Provisional Patent Application Serial No. 63/402,964, entitled “Talar Repair Jig”, filed on this date and invented by this inventor (Attorney Docket No. TYB-060); U.S. Provisional Patent Application Serial No. 63/402,971, entitled “Syndesmosis Repair Jig Assembly and Method of Use", filed on this date and invented by this inventor (Attorney Docket No. TYB-061); U.S. Provisional Patent Application Serial No.
  • exemplary is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the word exemplary is intended to present concepts in a concrete fashion.
  • the present invention is a tibial osteotomy system that can be used to repair distal tibial fractures and to perform a distal tibial and supramalleolar osteotomies using a minimally invasive technique.
  • the osteotomies can include the addition of a wedge to correct angulation in a first direction, or the removal of a wedge-shaped portion of the tibia to correct angulation in a second direction, opposite from the first direction.
  • the inventive system also can support a curved osteotomy system to achieve Dome osteotomy (as shown in FIGS. 1 and 2).
  • System 100 includes an elongate nail 110 and a plurality of fixation screws 130, 132 that are inserted through a tibia 50 and nail 110 to support tibia 50 after an osteotomy.
  • Nail 110 has an elongate body 112 having an oblong cross-section.
  • cross-section has a major diameter of about 1 cm and a minor diameter of about 0.5 cm.
  • Body 112 also has an arcuate length so that nail 100 can extend upwardly through tibia 50 from the medial malleolus 52 to a location part way up tibia 50, while remaining totally within the confines of tibia 50.
  • the arcuate length of body 110 can have a constant radius of curvature (FIG. 1) or, alternatively, a body 110' having a varying radius of curvature along its length (FIG. 1A), depending on the particular anatomy of each patient.
  • a malleolar portion 114 of body 112 has a first plurality of through openings 118 through the minor diameter to allow for insertion of fixation screws 132 therethrough. As shown in FIG. 1, three malleolar fixation screws 132 are shown, although those skilled in the art will recognize that more or less than three screws 132 can be used.
  • a proximal portion 116 of body 112 has a second plurality of through openings 120 to allow for insertion of fixation screws 130 therethrough. As shown in FIG. 1, two fixation screws 130 are shown, although those skilled in the art will recognize that more or less than two screws 130 can be used. In an exemplary embodiment, screws 130 are multidirectional and interference locking with body 112. Approximately 40 mm of proximal portion 116 is tapered to aid in insertion and reduce stress risers to terminate as a bullet tip with dimensions of about 2x2 mm.
  • the oblong cross section of body 112 provides more surface area for through openings 118, 120 to be formed through body 112 across the minor diameter, as compared to a nail having an oval or round cross section, which can weaken body 112 sufficiently to reduce the efficacy of system 100.
  • nail 110 has a length of about 150 - 250mm and can be constructed from Titanium, 316L Stainless Steel or Coated Magnesium Alloy. Further, in an exemplary embodiment, fixation screws 132 can have a length of between about 25mm and about 70mm.

Abstract

A distal tibia osteotomy system includes a nail having an elongate body. The body has an oblong cross section and an arcuate length. A plurality of fixation are provided for insertion into the nail.

Description

TITLE OF THE INVENTION
Distal Tibial Osteotomy System BACKGROUND OF THE INVENTION
[0001] Field of the Invention
[0002] The invention relates to a nail for implantation into a tibia to aid in performing an osteotomy or fracture fixation.
[0003] Description of the Related Art
[0004] Tibial fractures often require the use of plates to repair the fracture. Such repairs often lead to poor fusion with non-union of the bone portions and loss of fixation.
[0005] It would be beneficial to provide a distal tibial repair system that can be used to support fracture repair and osteotomies.
SUMMARY OF THE INVENTION
[0006] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
[0007] In one embodiment, the present invention is a distal tibia osteotomy system that includes a nail having an elongate body. The body has an oblong cross section and an arcuate length. A plurality of fixation are provided for insertion into the nail.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
[0009] FIG. 1 is a side elevational view of a distal tibial osteotomy system according to an exemplary embodiment of the present invention implanted in a tibia;
[0010] FIG. 1A is a side elevational view of a distal tibial osteotomy nail according to an alternative exemplary embodiment of the present invention; [0011] FIG. 2 is a front elevational view of the system and tibia of FIG. 1; and [0012] FIG. 3 is an enlarged view of the system and tibia of FIG. 1, taken along circle 3 of FIG. 1.
DETAILED DESCRIPTION
[0013] U.S. Provisional Patent Application Serial No. 63/402,961, entitled "Ligament/Tendon Suture with Paired Anchor System", filed on this date and invented by this inventor (Attorney Docket No. TYB-056); U.S. Provisional Patent Application Serial No. 63/402,962, entitled "Screw Capture System for Calcaneal Fracture", filed on this date and invented by this inventor (Attorney Docket No. TYB-057); U.S. Provisional Patent Application Serial No. 63/402,965, entitled "Screw Blade Capture System", filed on this date and invented by this inventor (Attorney Docket No. TYB-058); U.S. Provisional Patent Application Serial No. 63/402,967, entitled "Repair Plate System from Inside/Out" ), filed on this date and invented by this inventor (Attorney Docket No. TYB-059); U.S. Provisional Patent Application Serial No. 63/402,964, entitled "Talar Repair Jig", filed on this date and invented by this inventor (Attorney Docket No. TYB-060); U.S. Provisional Patent Application Serial No. 63/402,971, entitled "Syndesmosis Repair Jig Assembly and Method of Use", filed on this date and invented by this inventor (Attorney Docket No. TYB-061); U.S. Provisional Patent Application Serial No. 63/402,963, entitled "External Fixation System", filed on this date and invented by this inventor (Attorney Docket No. TYB-063); and U.S. Provisional Patent Application Serial No. 63/02,970, entitled "Achilles Tendon Repair Jig", filed on this date and invented by this inventor (Attorney Docket No. TYB-064), are all incorporated herein by reference in their entireties.
[0014] In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention. [0015] Reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the invention. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term "implementation."
[0016] As used in this application, the word "exemplary" is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the word exemplary is intended to present concepts in a concrete fashion.
[0017] Additionally, the term "or" is intended to mean an inclusive "or" rather than an exclusive "or". That is, unless specified otherwise, or clear from context, "X employs A or B" is intended to mean any of the natural inclusive permutations. That is, if X employs A; X employs B; or X employs both A and B, then "X employs A or B" is satisfied under any of the foregoing instances. In addition, the articles "a" and "an" as used in this application and the appended claims should generally be construed to mean "one or more" unless specified otherwise or clear from context to be directed to a singular form.
[0018] Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word "about" or "approximately" preceded the value of the value or range.
[0019] The use of figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.
[0020] The present invention is a tibial osteotomy system that can be used to repair distal tibial fractures and to perform a distal tibial and supramalleolar osteotomies using a minimally invasive technique. The osteotomies can include the addition of a wedge to correct angulation in a first direction, or the removal of a wedge-shaped portion of the tibia to correct angulation in a second direction, opposite from the first direction. The inventive system also can support a curved osteotomy system to achieve Dome osteotomy (as shown in FIGS. 1 and 2).
[0021] Referring to FIGS. 1-3, a distal tibia osteotomy system 100 ("system 100") is shown. System 100 includes an elongate nail 110 and a plurality of fixation screws 130, 132 that are inserted through a tibia 50 and nail 110 to support tibia 50 after an osteotomy.
[0022] Nail 110 has an elongate body 112 having an oblong cross-section. In an exemplary embodiment, cross-section has a major diameter of about 1 cm and a minor diameter of about 0.5 cm. Body 112 also has an arcuate length so that nail 100 can extend upwardly through tibia 50 from the medial malleolus 52 to a location part way up tibia 50, while remaining totally within the confines of tibia 50. The arcuate length of body 110 can have a constant radius of curvature (FIG. 1) or, alternatively, a body 110' having a varying radius of curvature along its length (FIG. 1A), depending on the particular anatomy of each patient.
[0023] A malleolar portion 114 of body 112 has a first plurality of through openings 118 through the minor diameter to allow for insertion of fixation screws 132 therethrough. As shown in FIG. 1, three malleolar fixation screws 132 are shown, although those skilled in the art will recognize that more or less than three screws 132 can be used.
[0024] A proximal portion 116 of body 112 has a second plurality of through openings 120 to allow for insertion of fixation screws 130 therethrough. As shown in FIG. 1, two fixation screws 130 are shown, although those skilled in the art will recognize that more or less than two screws 130 can be used. In an exemplary embodiment, screws 130 are multidirectional and interference locking with body 112. Approximately 40 mm of proximal portion 116 is tapered to aid in insertion and reduce stress risers to terminate as a bullet tip with dimensions of about 2x2 mm.
[0025] The oblong cross section of body 112 provides more surface area for through openings 118, 120 to be formed through body 112 across the minor diameter, as compared to a nail having an oval or round cross section, which can weaken body 112 sufficiently to reduce the efficacy of system 100.
[0026] In an exemplary embodiment, nail 110 has a length of about 150 - 250mm and can be constructed from Titanium, 316L Stainless Steel or Coated Magnesium Alloy. Further, in an exemplary embodiment, fixation screws 132 can have a length of between about 25mm and about 70mm.
[0027] It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the following claims.

Claims

CLAIMS What is claimed is:
1. A distal tibia osteotomy system comprising: a nail having an elongate body, the body having an oblong cross section and an arcuate length; and a plurality of fixation screws configured for insertion into the nail.
2. The distal tibia osteotomy system according to claim 1, wherein the cross section has a major diameter of about 1 cm.
3. The distal tibia osteotomy system according to claim 1, wherein the cross section has a minor diameter of about 0.5 cm.
4. The distal tibial osteotomy system according to claim 3, wherein the body further comprises a plurality of through openings extending therethrough across the minor diameter, wherein the plurality of through openings are each sized to accept one of the plurality of fixation screws.
5. The distal tibia osteotomy system according to claim 1, wherein the arcuate length is configured such that the nail can extend upwardly through a tibia from a medial malleolus to a location part way up the tibia, while remaining totally within the confines of the tibia.
6. The distal tibia osteotomy system according to claim 1, wherein the arcuate length has a constant radius of curvature.
7. The distal tibia osteotomy system according to claim 1, wherein the arcuate length has a varying radius of curvature along its length, depending on the particular anatomy of each patient.
8. The distal tibia osteotomy system according to claim 1, wherein the body further comprises a malleolar portion having a first plurality of through openings configured to allow for insertion of some of the plurality of fixation screws therethrough.
9. The distal tibia osteotomy system according to claim 1, wherein the body further comprises a proximal portion having a second plurality of through openings configured to allow for insertion of a remainder of the plurality of fixation screws therethrough.
10.The distal tibial osteotomy system according to claim 9, wherein the proximal portion is tapered.
11.The distal tibial osteotomy system according to claim 10, wherein tapered proximal portion ends in a bullet tip. The distal tibia osteotomy system according to claim 1, wherein the body is constructed from the group consisting of Titanium, 316L Stainless Steel and Coated Magnesium Alloy. The distal tibial osteotomy system according to claim 1, wherein the body extends between about 150 mm and 250 mm in length. The distal tibial osteotomy system according to claim 1, wherein each of the plurality of fixation screws has a length of between about 25 mm and about 75 mm.
PCT/IB2023/000522 2022-09-01 2023-08-30 Distal tibial osteotomy system WO2024047399A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263402969P 2022-09-01 2022-09-01
US63/402,969 2022-09-01

Publications (1)

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WO2024047399A1 true WO2024047399A1 (en) 2024-03-07

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1330988A2 (en) * 2002-01-18 2003-07-30 Aesculap AG & Co. KG Intramedullary implant for osteosynthesis
US20130158553A1 (en) * 2011-12-20 2013-06-20 Synthes Usa, Llc Self Centering Feature for an Intramedullary Nail
CN110584764A (en) * 2019-10-25 2019-12-20 大博医疗科技股份有限公司 Tibia fixing device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1330988A2 (en) * 2002-01-18 2003-07-30 Aesculap AG & Co. KG Intramedullary implant for osteosynthesis
US20130158553A1 (en) * 2011-12-20 2013-06-20 Synthes Usa, Llc Self Centering Feature for an Intramedullary Nail
CN110584764A (en) * 2019-10-25 2019-12-20 大博医疗科技股份有限公司 Tibia fixing device

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