WO2023141032A1 - Entretoise motorisée destinée à être utilisée dans un cadre spatial motorisé - Google Patents

Entretoise motorisée destinée à être utilisée dans un cadre spatial motorisé Download PDF

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Publication number
WO2023141032A1
WO2023141032A1 PCT/US2023/010393 US2023010393W WO2023141032A1 WO 2023141032 A1 WO2023141032 A1 WO 2023141032A1 US 2023010393 W US2023010393 W US 2023010393W WO 2023141032 A1 WO2023141032 A1 WO 2023141032A1
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WO
WIPO (PCT)
Prior art keywords
motorized
strut
threaded rod
rod
distraction
Prior art date
Application number
PCT/US2023/010393
Other languages
English (en)
Inventor
Paul Bell
Sied W. Janna
Andrew P. NOBLETT
Original Assignee
Smith & Nephew, Inc.
Smith & Nephew Orthopaedics Ag
Smith & Nephew Asia Pacific Pte. Limited
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 Smith & Nephew, Inc., Smith & Nephew Orthopaedics Ag, Smith & Nephew Asia Pacific Pte. Limited filed Critical Smith & Nephew, Inc.
Publication of WO2023141032A1 publication Critical patent/WO2023141032A1/fr

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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
    • A61B17/60Surgical 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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/62Ring frames, i.e. devices extending around the bones to be positioned
    • 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
    • A61B17/60Surgical 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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66Alignment, compression or distraction mechanisms
    • 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
    • A61B17/60Surgical 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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6416Devices extending alongside the bones to be positioned with non-continuous, e.g. hinged, pin-clamp connecting element
    • 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
    • A61B17/60Surgical 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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/645Devices extending alongside the bones to be positioned comprising a framework

Definitions

  • the present disclosure relates generally to orthopedic devices, systems, and methods for facilitating fracture alignment such as the treatment of musculoskeletal conditions, and particularly to motorized struts for use in a bone alignment device, an external fixation system, etc., such as, for example, a spatial frame.
  • the motorized strut may include a secondary telescoping member to provide manual adjustment of the overall length of the motorized strut without requiring actuation of the motor.
  • the motorized strut may include a multi-stage or dual-stage threaded rod assembly to provide an increased working range without substantially increasing the minimum length of the motorized strut.
  • a person that suffers a bone fracture is required to use a bone alignment device, an external fixation system, etc., such as, for example, a spatial frame, a hexapod, etc. (terms used interchangeably herein without the intent to limit or distinguish) to align two or more bones, bone fragments, bone pieces, etc. (terms used interchangeably herein without the intent to limit or distinguish).
  • a spatial frame allow for polyaxial movement of the coupled bones and are typically used to keep fractured bones stabilized and in alignment during a treatment period.
  • the spatial frame may include first and second rings, platforms, frames, bases, etc. (terms used interchangeably herein without the intent to limit or distinguish) intercoupled by a plurality of struts.
  • the struts have adjustable lengths that may be manually adjusted regularly (e.g., daily) in accordance with a prescription or treatment plan (terms used interchangeably herein without the intent to limit or distinguish).
  • a prescription or treatment plan (terms used interchangeably herein without the intent to limit or distinguish).
  • the treatment plan specifies strut length adjustments to be made to each of the struts over time to ensure successful bone alignment.
  • TAYLOR SPATIAL FRAME® manufactured and sold by Smith Nephew, Inc.
  • the TAYLOR SPATIAL FRAME® is based on the general concept of a Stewart platform. Smith & Nephew, Inc. is the owner of U.S. Patent Nos. 5,702,389; 5,728,095; 5,891,143; RE40,914, 5,971,984; 6,030,386; and 6,129,727; and U.S. Published Patent Application Nos.
  • the spatial frame 100 may form a hexapod having a circular, metal frame with a first platform 102 and a second platform 104 connected by six adjustable length struts 106 (labeled as struts 106-1 through 106-6 in FIG. 1). Each strut 106 may be independently lengthened or shortened relative to the rest of the frame, thereby allowing for six different axes of movement.
  • Each strut 106 may include an outer body and an inner body, which may be configured as, or be operatively coupled to, a threaded rod (also referred to as a lead screw).
  • the outer body may be coupled to one of the platforms, such as, the second platform 104 by way of a joint as shown.
  • the inner body may be coupled to the other platform, such as, the first platform 102 by way of a joint as shown.
  • the outer body and the inner body may be moved or translated relative to one another.
  • the spatial frame 100 may be used to treat a variety of skeletal fractures of a patient.
  • the spatial frame 100 is positioned around the patient and is used to align two or more bone portions.
  • a length of each strut 106 may be incrementally adjusted (e.g., shortened or lengthened) in accordance with a treatment plan that specifies adjustments to be made to each strut 106 over time to ensure successful bone alignment.
  • the length of each strut 106 should be adjusted daily to comply with the provided treatment plan. Adjusting the length of each strut 106 adjusts the distance between the first and second platforms 102, 104, and hence the first and second bone portions coupled thereto.
  • patient’s bones are normally adjusted (e.g., lengthened, shortened, etc.) manually, for example, by hand or a wrench at a rate of approximately 1 mm/day, which is then proceeded by a consolidation phase before the spatial frame is removed.
  • the Robotic Hexapod System is the Robotic Hexapod System manufactured by Orthospin Ltd.
  • the Robotic Hexapod System includes an offset motor design that engages custom struts positioned between the first and second platforms. That is, the motor includes a first gear engaged with a second gear associated with the threaded rod of the strut. In use, rotation from the motor drives rotation of the threaded rod via the interaction between the first and second gears.
  • the Robotic Hexapod System however suffers from a number of disadvantages. First, the Robotic Hexapod System is very bulky. Second, while the motorized strut offers a relatively short minimum length, the minimum length could be further improved. Third, the working range of the motorized strut is constrained by the length of the threaded rod.
  • the treatment plan may require multiple daily adjustments to be made to each of the plurality of struts.
  • a patient may be required to manually adjust one or more of the struts, typically two or more times each day, and often over long periods of time with support from either a family member, a clinician, or both.
  • compliance with the treatment plan may be burdensome, painful, and prone to errors, which may rise as the number of manual daily adjustment increases.
  • the number of adjustments dictated by the treatment plan may be limited.
  • treatment plans often limit the required number of daily adjustments to each of the plurality of struts to four per day. During a normal treatment plan, this may equate to approximately 720 adjustments (e.g., turns) over a one-month treatment span (e.g., 6 struts x 4 adjustments per day x 30 days).
  • this may equate to approximately 2,160 adjustments (e.g., turns) over a three-month treatment span (e.g., 6 struts x 4 adjustments per day x 90 days).
  • the patient may require numerous clinical visits to confirm proper strut adjustments to ensure compliance and avoid incorrect adjustment, which has historically been the leading cause of treatment failure.
  • Motorized and/or automated spatial frames could provide numerous advantages over manually adjustable struts.
  • electric motors, motor-drive units, and a control unit e.g., a central control unit
  • a control unit e.g., a central control unit
  • an automated and/or motorized system could eliminate the need for patient compliance and decrease the frequency of postoperative visits for patient supervision given that the spatial frame may only need to be activated at the start of the distraction phase and terminated at the end of the distraction phase without any patient intervention.
  • the burden of manual adjustment can be overcome by automating and/or motorizing the struts, which in turn, enables a more independent lifestyle during treatment.
  • automated and/or motorized spatial frames allow the implementation of more diverse treatment schedules.
  • automatic and/or motorized distraction could enable a higher distraction frequency and result in smaller excursions per activation. Smaller excursions or adjustments have the potential to result in less damage to the distracted tissues, improving bone regeneration and adaptation of the surrounding soft tissues.
  • spatial frames equipped with motorized struts offer the potential to increase the number of daily distraction adjustments by enabling finer (e.g., smaller) adjustments at a controllable rate and frequency of distraction that encourages better quality bone formation.
  • Making finer (e.g., smaller) adjustments during limb lengthening can have significant advantages in terms of reduced soft tissue damage, less pain, and opioid usage and accelerated bone healing.
  • the bone fixation index was only 5-6 days/cm when using motorized and/or automated distraction compared to 22-24 days/cm by manual adjustment.
  • a motorized strut could be programmed to perform anywhere from one adjustment per day to continuous adjustments. Finer adjustments could increase the number of adjustments over a one-month period from approximately 720 adjustments to approximately 3,600 adjustments (e.g., 6 struts x 20 adjustments per day x 30 days). Alternatively, finer adjustments could increase the number of adjustments over a one-month period to approximately 259,200 adjustments (e.g., 6 struts x 1440 adjustments per day x 30 days). Over an extended three-month treatment period, this could increase the number of adjustments from approximately 2,160 adjustments to approximately 10,800 adjustments (e.g., 6 struts x 20 adjustments per day x 90 days). Alternatively, finer adjustments could increase the number of adjustments over a three- month period to approximately 777,600 adjustments (e.g., 6 struts x 1440 adjustments per day x 90 days).
  • each motorized strut may include a motor and may be used in a spatial frame such as, for example, spatial frame 100, to move the first and second platforms 102, 104, respectively, to align two or more bone portions.
  • the spatial frame and/or system architecture may be arranged and configured to automatically adjust the motorized struts according to the prescribed treatment plan (e.g., automatically adjust the plurality of motorized struts without patient intervention).
  • the spatial frame and/or system architecture may be arranged and configured to require patient and/or caregiver activation to begin the process of automatically adjusting the motorized struts according to the prescribed treatment plan.
  • the spatial frame may be arranged to intermittently auto-adjust the motorized struts at predetermined times according to the treatment plan.
  • the spatial frame may be arranged to intermittently auto-adjust the motorized struts at select times when convenient and/or selected by the patient.
  • the spatial frame may be arranged and configured to continuously auto-adjust the motorized struts in small discrete increments.
  • the motorized strut 200 may be coupled to first and second platforms in a spatial frame.
  • the motorized strut 200 may be used in place of the manually adjustable struts 106 shown in FIG. 1.
  • the motorized strut 200 may include an outer body 202 operatively coupled with a first joint 204 for coupling to a first platform, an inner body 210 operatively coupled with a second joint 212 for coupling to a second platform, and a drive mechanism, actuator, etc. 220 (used interchangeably herein without the intent to limit or distinguish).
  • actuation of the drive mechanism 220 moves the inner body 210 relative to the outer body 202 to adjust a length of the motorized strut 200.
  • the drive mechanism 220 may include a motor 222 and a threaded rod or lead screw 224 arranged and configured so that, in use, actuation of the motor 222 rotates the threaded rod 224, which moves the inner body 210 relative to the outer body 202 to adjust an overall length of the motorized strut 200.
  • the drive mechanism 220 may include one or more gears to adjust speed and torque of the motor 222.
  • the motorized strut 200 may include any required circuity.
  • the motorized strut 200 may include one or more position sensors to, for example, monitor absolute position or length of the motorized strut 200.
  • the motorized strut 200 may include other sensors for monitoring various biomechanical parameters such as, for example, a force sensor 230 for monitoring stresses and forces, across the bone gap and/or the soft tissues (muscle, apposing cartilage or peripheral sensory nerves), a sensor motor support 232, etc.
  • the motorized strut 200 may include an encoder such as, for example, a rotary encoder for measuring rotation from the motor 222.
  • the motorized strut 200 may include memory for storing unique identifiers (e.g., addresses) for storing current position, etc.
  • the motorized strut 200 may be arranged and configured with an in-line design, wherein the motor 222 shares a common longitudinal axis as the threaded rod 224 and the telescoping portion (e.g., inner body 210).
  • in-line motorized struts offer a number of design benefits
  • one problem associated with in-line motorized struts is the relatively lengthy minimum length required of the motorized strut. That is, in order for the motor to be positioned in-line with the threaded rod, a longer minimum length is needed compared to off-axis designs where the longitudinal axis of the motor is offset from the longitudinal axis of the threaded rod.
  • the treatment plan may require the spacing of the platforms 102, 104 to have a large workable range including a very small minimum distance apart and a very large maximum distance apart.
  • an in-line motorized strut may be unable to meet the entire workable range specified by the treatment plan.
  • the struts may need to be changed out or swapped by other struts during the treatment period to accommodate the full workable range of the spatial frame. Changing out the struts may be tedious and may be uncomfortable to the patient.
  • the motorized struts could incorporate a quick or manual adjustment feature that enables the length of the motorized struts to be quickly adjusted (e.g., lengthen or shorten).
  • the motorized struts it would be advantageous for the motorized struts to enable manual adjustment of the motorized struts, during, for example, initial setup (e.g., construction, assembly, and/or attachment) of the spatial frame to the patient’s bone (e.g., leg).
  • the motorized strut it would be beneficial to enable the motorized strut to be manually adjustable to enable quicker or faster lengthening or shortening of the motorized struts (e.g., to allow the surgeon to freely telescope the motorized struts to quickly adjust the length of the motorized struts without requiring actuation of the motor, which is designed and configured for smaller and slower adjustments). Thereafter, actuation of the struts can be performed by the motor in order to make discrete, incremental adjustments of the overall length of the strut during, for example, the distraction phase according to the treatment plan.
  • in-line motorized strut having a smaller minimum length in the fully retracted position as compared to conventional inline motorized struts.
  • in-line motorized strut having a quick or manual adjustment mechanism to enable surgeons to selectively enable quicker and/or manual adjustment to the overall length of the motorized struts during initial setup of the spatial frame. It is with respect to these and other considerations that the present disclosure may be useful.
  • a motorized strut is disclosed.
  • the motorized strut may be used in a spatial frame.
  • the motorized strut may be used as a stand-alone device or as part of an external fixation system including, for example, clamps for engaging bone pins, etc.
  • the spatial frame when used in a spatial frame, includes a plurality of motorized struts coupled to first and second platforms. In use, movement of the motorized struts move the first and second platforms, and hence the first and second bone portions coupled thereto.
  • the motorized struts include an outer or first body, an inner or second body, a threaded rod operatively coupled to the inner or second body, a motor operatively coupled to the threaded rod so that actuation of the motor rotates the threaded rod causing the inner or second body to move relative to the outer or first body to adjust an overall length of the motorized strut, and a secondary telescoping member arranged and configured to couple to the outer or first body, the secondary telescoping member being selectively moveable relative to the outer or first body so that the overall length of the motorized strut can be manually adjusted by moving the secondary telescoping member relative to the outer or first body.
  • the motor includes a longitudinal axis
  • the threaded rod includes a longitudinal axis
  • the inner or second body includes a longitudinal axis, the longitudinal axis of the motor being aligned with the longitudinal axis of the threaded rod and the inner or second body.
  • the secondary telescoping member is coupled to the outer or first body at a first end, the inner or second body being positioned along a second end opposite of the first end.
  • the secondary telescoping member includes a first coupling mechanism such as, for example, a first joint for coupling to the first platform and the inner or second body includes a second coupling mechanism such as, for example, a second joint for coupling to the second platform.
  • the secondary telescoping member includes a body having an interior cavity for receiving a portion of the outer or first body so that, in use, the secondary telescoping member can translate relative to the outer or first body.
  • the secondary telescoping member is selectively fixed to the outer or first body via a fastening mechanism.
  • the fastening mechanism includes a threaded bolt, the body of the secondary telescoping member including a slot formed therein so that, in use, the bolt passes through the slot formed in the body and into threaded engagement with the outer or first body.
  • the threaded rod is an inner threaded rod and the motorized strut further includes a second, outer threaded rod, the inner threaded rod being coupled to the motor and includes external threads, the outer threaded rod including internal threads to engage the external threads of the inner threaded rod and external threads to engage the inner or second body.
  • the motorized strut further including an outer distraction rod
  • initial rotation from the motor causes the inner or second body to translate relative to the outer distraction rod and the outer or first body until a stop formed on the inner or second body contacts a second stop formed on the outer distraction rod
  • thereafter continued rotation from the motor causes the outer threaded rod to move relative to the inner threaded rod
  • the outer distraction rod to translate relative to the outer or first body to adjust the overall length of the motorized strut.
  • the inner or second body and the outer distraction rod include an anti-rotation mechanism to prevent relative rotation between the inner or second body and the outer distraction rod.
  • the outer or first body may also include an anti-rotation mechanism to prevent relative rotation with the outer distraction rod.
  • a motorized strut including a multi-stage or dual-stage threaded rod assembly including a first outer body, a second outer body, a chassis arranged and configured to couple the first outer body to the second outer body, an outer distraction rod, an inner distraction rod, an inner threaded rod, an outer threaded rod, and a motor operatively coupled to the inner threaded rod so that actuation of the motor rotates the inner threaded rod.
  • the inner threaded rod including external threads
  • the outer threaded rod including internal threads to engage the external threads of the inner threaded rod and external threads to engage the inner distraction rod.
  • initial rotation from the motor causes the inner distraction rod to translate relative to the outer distraction rod and the second outer body until a stop formed on the inner distraction rod contacts a second stop formed on the outer distraction rod, thereafter continued rotation from the motor causes the outer threaded rod to translate relative to the inner threaded rod, and the outer distraction rod to translate relative to the second outer body to adjust the overall length of the motorized strut.
  • the inner distraction rod and the outer distraction rod include an anti-rotation mechanism to prevent relative rotation between the inner distraction rod and the outer distraction rod.
  • the second outer body may also include an anti-rotation mechanism to prevent relative rotation with the outer distraction rod.
  • the motorized strut further includes a secondary telescoping member arranged and configured to couple to the first outer body, the secondary telescoping member being selectively moveable relative to the first outer body so that the overall length of the motorized strut can be manually adjusted by moving the secondary telescoping member relative to the first outer body.
  • the motor includes a longitudinal axis
  • the inner and outer threaded rods include a longitudinal axis
  • the inner and outer distraction rods include a longitudinal axis, the longitudinal axis of the motor being aligned with the longitudinal axis of the inner and outer threaded rods and the inner and outer distraction rods.
  • the secondary telescoping member is coupled to the first outer body at a first end, the inner distraction rod being positioned along a second end opposite of the first end.
  • the secondary telescoping member includes a first coupling mechanism such as, for example, a first joint for coupling to the first platform and the inner distraction rod includes a second coupling mechanism such as, for example, a second joint for coupling to the second platform.
  • the secondary telescoping member includes a body having an interior cavity for receiving a portion of the first outer body so that, in use, the secondary telescoping member can translate relative to the first outer body.
  • the secondary telescoping member is selectively fixed to the first outer body via a fastening mechanism.
  • the fastening mechanism includes a threaded bolt, the body of the secondary telescoping member including a slot formed therein so that, in use, the bolt passes through the slot formed in the body and into threaded engagement with the first outer body.
  • a motorized strut including a secondary telescoping member or additional outer housing component provides a quick, manual adjustment mechanism for enabling overall length adjustment of the motorized strut without requiring actuation of the motor.
  • the motorized strut can provide an increased working range while not substantially increasing the minimum length of the motorized strut.
  • FIG. 1 illustrates a perspective view of a conventional spatial frame
  • FIG. 2 illustrates a cross-sectional view of an example of a motorized strut that may be used in a spatial frame
  • FIG. 3 illustrates a perspective view of an example of a motorized spatial frame including an integrated control unit and power supply
  • FIG. 4 illustrates a cross-sectional view of an example of a motorized strut in accordance with one or more features of the present disclosure, in use, the motorized strut may be used in, for example, a spatial frame;
  • FIGS. 5A-5C illustrate cross-sectional views of an alternate example of a motorized strut in accordance with one or more features of the present disclosure, in use, the motorized strut may be used in, for example, a spatial frame
  • FIG. 5A illustrates the motorized strut in a fully retracted position
  • FIG. 5B illustrates the motorized strut in a partially extended position
  • FIG. 5C illustrates the motorized strut in a fully extended position
  • FIGS. 6A-6D illustrate cross-sectional views of an alternate example of a motorized strut in accordance with one or more features of the present disclosure, in use, the motorized strut may be used in, for example, a spatial frame
  • FIG. 6A illustrates the motorized strut in a fully retracted position
  • FIGS. 6B and 6C illustrate the motorized strut in partially extended positions
  • FIG. 6D illustrates the motorized strut in a fully extended position
  • FIGS. 7A-7C illustrate various detailed views of the motorized strut shown in FIGS. 5A-5C, the FIGS, illustrating examples of the anti-rotational features and flanges.
  • motorized struts as disclosed herein may be embodied in many different forms and may selectively include one or more concepts, features, or functions described herein. As such, the motorized strut should not be construed as being limited to the specific examples set forth herein. Rather, these examples are provided so that this disclosure will convey certain features of the motorized strut to those skilled in the art.
  • a motorized strut and more preferably an in-line motorized strut, having a multi-stage or dual-stage threaded rod assembly
  • the in-line motorized strut may be arranged and configured with a shorter minimum length (e.g., length of the motorized strut as measured end to end (e.g., coupling mechanism to coupling mechanism or joint to joint) with the threaded rod assembly in the fully retracted position) as compared to conventional in-line motorized struts, while still providing a reasonable working length (e.g., adjustment length of the motorized strut in use - length adjustment, difference, or throw between the minimum length and the maximum length of the motorized strut).
  • a shorter minimum length e.g., length of the motorized strut as measured end to end (e.g., coupling mechanism to coupling mechanism or joint to joint) with the threaded rod assembly in the fully retracted position
  • a reasonable working length e.g., adjustment length of the motorized
  • an in-line motorized strut having a multi-stage or dual- stage threaded rod assembly could be configured to provide, for example, a maximum length of approximately 310mm or more and a minimum length of approximately 90mm with a working length or throw of approximately 30mm, although this is but one configuration and increasing or decreasing the working length or throw could increase or decrease the minimum length of the motorized strut. For example, with a working length or throw of approximately 20mm, the minimum length would be approximately 85mm.
  • the in-line motorized strut may include a quick adjustment mechanism arranged and configured to enable a surgeon to selectively enable quicker and/or manual adjustment to the overall length of the motorized struts during, for example, initial setup of the spatial frame. That is, the motorized strut may be arranged and configured so that actuation of the motor is not required to adjust an overall length of the motorized strut. For example, the overall length of the motorized struts can be adjusted by manually adjusting the position of a secondary member or body relative to the motorized strut.
  • a surgeon can quickly, and more efficiently, manually adjust the plurality of motorized struts to their initial length during, for example, initial construction of the spatial frame (e.g., the surgeon can freely move or adjust the overall lengths of the motorized struts without actuation of the motors, which is useful during, for example, fracture reduction during trauma surgery or initially pre-setting the motorized struts to desirable positions).
  • actuation of the motor is required to move, translate, etc. the inner body relative to the outer body to adjust the overall length of the motorized strut. That is, the threaded rod can be adjusted by actuation of the motor to adjust the overall length of the motorized strut.
  • a patient or caregiver can actuate the motor to more precisely control and adjust the overall length of the plurality of motorized struts (e.g., the motorized struts are arranged and configured to move more slowly and more precisely so that, for example, during the correction phase, precise adjustments can be made to the overall lengths of the motorized struts).
  • the motorized struts are arranged and configured to move more slowly and more precisely so that, for example, during the correction phase, precise adjustments can be made to the overall lengths of the motorized struts).
  • the motorized strut may be used in a spatial frame.
  • the motorized strut may be used in other applications.
  • the motorized strut may be used in connection with an external fixation system wherein the motorized strut may include external fixation clamps including, for example, multi-pin clamps to engage pins coupled to a patient’s bone.
  • the present disclosure should not be limited to a spatial frame unless specifically claimed.
  • the motorized struts when arranged in, for example, a spatial frame, may be arranged and configured to receive power and to exchange data with a control unit (e.g., PCB modules).
  • the motorized struts may be operatively coupled to the control unit via, for example, a hardwired connection, although it is envisioned that the motorized struts may receive power and/or exchange data with the control unit by any other suitable mechanism now known or hereafter developed including, for example, wireless power and/or data transmission.
  • the motorized struts may be arranged and configured to be operatively coupled to the control unit for receiving power, exchanging data, or a combination thereof.
  • the motorized struts need not incorporate individual power supplies (e.g., a battery, etc. as such each motorized strut may be battery-less or devoid of any power supply), although it is envisioned that the motorized struts may incorporate a power supply unit (e.g., battery).
  • a battery-less motorized strut design and manufacture of the motorized struts is simplified thereby minimizing, or at least reducing, motorized strut complexity and thus likelihood that individual motorized struts will fail.
  • the motorized struts may include a communications interface for coupling to the control unit.
  • the communication interface may be used to exchange data with the control unit and/or to receive power from the control unit.
  • the communication interface may be any suitable interface now known or hereafter developed.
  • the communication interface may be configured to exchange data over a wired connection.
  • the communication interface may be configured to exchange data over a wireless connection.
  • the motorized struts may be water-proofed to facilitate the patient, for example, taking a shower or bath.
  • bellows may be coupled to the ends of the motorized struts or the individual external housing components of the motorized strut may be sealed with O-rings.
  • the motorized struts and/or the spatial frame may be covered by, for example, a bag during a shower thus alleviating the necessity for water-proofing each of the motorized struts.
  • the motorized struts may be arranged and configured to be used in a spatial frame.
  • the spatial frame includes a plurality of motorized struts coupled to first and second platforms.
  • movement of the motorized struts move the first and second platforms, and hence the first and second bone portions coupled thereto.
  • FIG. 3 an example of a motorized spatial frame 300 is illustrated.
  • the motorized spatial frame 300 includes a first platform such as, for example, first platform 102, a second platform such as, for example, second platform 104, and a plurality of motorized struts such as, for example, motorized struts 200, coupled to the first and second platforms 102, 104.
  • the motorized spatial frame 300 may include a control unit.
  • the control unit may be arranged and configured to: (i) supply power to the motorized struts; (ii) exchange (e.g., receive and/or transmit) data with the motorized struts such as, for example, exchange positional data and/or instructions with the motorized struts; (iii) control each of the motors of the motorized struts for which it is responsible; and (iv) store and update current positional data associated with each of the motorized struts.
  • the control unit may be arranged and configured to communicate with an external computing system to, for example, receive spatial frame treatment plans and/or updates.
  • control unit may be arranged and configured to exchange data such as, for example, a treatment plan, with the external computing system and to exchange data such as, for example, adjustment instructions, with the plurality of motorized struts.
  • control unit may be arranged and configured to deliver power to the plurality of motorized struts.
  • control unit may be arranged and configured to control and/or power the plurality of motorized struts.
  • control unit may be in the form of one or more PCB modules positioned in the spaces or pockets 109 formed in the platform (illustrated as platform 104 in FIG. 3), the spaces or pockets 109 located between the laterally extending adjacent tabs 108 on, for example, an existing platform.
  • the controlling electronics may be embedded within the spaces or pockets 109 between the tabs 108.
  • the control unit may be provided as a plurality of separate and distinct PCB modules.
  • the control unit may include three separate PCB modules, although alternate configurations are envisioned including, for example, more or less PCB modules such as one, two, four, or more.
  • Each PCB module may be coupled to the platform of the motorized spatial frame 300.
  • the PCB modules control the movement of the motorized struts.
  • each PCB module may be responsible for controlling two motorized struts (e.g., each PCB module may include the needed circuity, power, and connectivity to control two (2) motorized struts).
  • each PCB module may be independently powered and operated as a stand-alone system.
  • each of the PCB modules may communicate with the other PCB modules wirelessly such as, for example, by Bluetooth Low Energy (BLE) or the like.
  • BLE Bluetooth Low Energy
  • each of the PCB modules may communicate with the other PCB modules via a wired connection.
  • each PCB module may include a PCB board and a battery board coupled to each other via a connector.
  • electrical connection between the PCB board and the battery board in each PCB module across the tabs 108 in the platform may be achieved using a flexi/flex-rigid PCB connector positioned in a narrow trench or groove formed in the platform.
  • a groove or recess may be provided in an arc in the perimeter of the platform to accommodate the flex rigid PCB connector.
  • the PCB board may include, for example, the microcontroller and associated electronics.
  • the battery board may include the power supply and associated electronics.
  • each battery board may include a plurality of coin cell batteries such as, for example, 3-coin cells, although this is but one configuration and other numbers and types of batteries may be utilized.
  • the PCB modules include communication interfaces for communicating with the motorized struts.
  • the PCB modules may incorporate integrated connectivity to enable connection to the motorized struts.
  • a wire loom or cable arranged and configured to provide data and/or power to the motorized struts may be provided.
  • the wire loom or cable may be arranged and configured with local terminations or connectors for exchanging data and providing power to the motorized struts.
  • the connectors may be any suitable connector arranged and configured to enable power and/or data transfer between the motorized struts and the PCB modules including, for example, jack plugs and sockets, a header connector, pogo pin connectors and socket assemblies at each of the six tabs 108 formed on the platform, etc.
  • the PCB modules may include a second communication interface for communicating with the external computing system and, in connection with preferred examples where three- separate and distinct PCB modules are provided, a communication interface so that each PCB module can communicate with the other PCB modules.
  • the PCB modules may be arranged and configured to synchronize movements of the motorized struts.
  • the PCB modules may be arranged and configured to control each motorized strut simultaneously or individually.
  • the PCB modules may be arranged and configured to control each motorized strut sequentially (e.g., the PCB modules may be arranged and configured to control (adjust) each of the motorized struts sequentially (e.g., one at a time), or in any combination thereof).
  • the motorized struts may be arranged and configured to transmit data to the PCB modules.
  • the motorized struts may include one or more sensors for transmitting data pertaining to strut position, forces acting upon the motorized struts, motor temperature, motor current, etc. to the PCB modules.
  • motorized spatial frame While a particular motorized spatial frame has been described and illustrated herein, the features of the present disclosure may be used in combination with other motorized spatial frames.
  • motorized struts could also be used in a non-hexapod configurations for pure lengthening or shortening, or even for bone transport.
  • the features of the present disclosure can also be applied to limb lengthening and bone transport intramedullary nails. Incorporation of motorized struts and the benefits of improved regenerative bone quality, elimination of manual adjustments, and possibly shorter time in the frame, makes utilization of motorized struts attractive in all types of applications including simpler frames.
  • the present disclosure should not be limited to the details of the motorized spatial frame disclosed and illustrated herein unless specifically claimed. Rather, it should be understood that the motorized struts of the present disclosure may be used in connection with any motorized spatial frame.
  • the control unit may be provided as a separate and distinct housing, which may be coupled to one of the platforms on the spatial frame. The control unit may then communicate, either wirelessly or via a wire, to each motorized strut within the spatial frame to provide power and/or transfer data.
  • a motorized strut 400 incorporating a secondary telescoping member is shown.
  • the motorized strut 400 may include an additional outer housing component to allow quicker and/or manual length adjustment of the strut without any rotation of the threaded rod that is driven by the motor.
  • the motorized strut 400 may be used in a motorized spatial frame such as, for example, in place of motorized struts 200 in spatial frame 300 or in any other suitable motorized spatial frame, external fixation system, etc. now known or hereafter developed.
  • the quick and/or manual length adjustment feature could be used in the operating room during initial setup of, for example, the spatial frame. That is, in use, the secondary telescoping member or additional outer housing component is arranged and configured to enable manual adjustment of the overall length of the motorized strut so that the surgeon can quickly adjust the length of the motorized strut as needed during initial setup in the operating room.
  • motorized strut 400 may, in some examples, have a similar construction as motorized strut 200 previously described except as provided for herein.
  • motorized strut 400 may have any other suitable configuration.
  • motorized strut 400 includes a first or outer body 402 (terms used interchangeably herein without the intent to limit), a second or inner body 410 (terms used interchangeably herein without the intent to limit) operatively coupled with a second coupling mechanism shown as, for example, a second joint 412 for coupling to a second platform, and a drive mechanism 420 arranged and configured to move the inner body 410 relative to the outer body 402 to adjust a length of the motorized strut 400.
  • the drive mechanism 420 may include a motor 422.
  • the drive mechanism 420 may also include a threaded rod or lead screw 424 arranged and configured so that, in use, actuation of the motor 422 rotates the threaded rod 424, which moves the inner body 410 relative to the outer body 402 to adjust an overall length of the motorized strut 400.
  • the drive mechanism 420 may include one or more gears to adjust speed and torque of the motor 422.
  • the motorized strut 400 is arranged and configured with an in-line design, wherein the motor 422 shares a common longitudinal axis as the threaded rod 424 and the telescoping portion (e.g., inner body 410).
  • the motor 422 shares a common longitudinal axis as the threaded rod 424 and the telescoping portion (e.g., inner body 410).
  • the features of the present disclosure may be used in combination with motorized struts that have an off-axis design.
  • the motorized strut 400 may include any additional required or desired circuity.
  • the motorized strut 400 may include one or more position sensors to, for example, monitor absolute position or length of the motorized strut 400.
  • the motorized strut 400 may include other sensors for monitoring various biomechanical parameters such as, for example, a force sensor for monitoring stresses and forces, across the bone gap and/or the soft tissues (muscle, apposing cartilage or peripheral sensory nerves), a sensor motor support, etc.
  • the motorized strut 400 may include an encoder such as, for example, a rotary encoder for measuring rotation from the motor 422.
  • the motorized strut 400 may include memory for storing unique identifiers (e.g., addresses) for storing current position, etc.
  • the in-line motorized strut 400 includes a secondary telescoping member or additional outer housing component 450 (terms used interchangeably herein without the intent to limit or distinguish) to provide a quick adjustment mechanism for enabling overall length adjustment of the motorized strut 400 without requiring actuation of the motor 422 (e.g., the secondary telescoping member 450 enables manual adjustment of the overall length of the motorized strut 400).
  • the secondary telescoping member 450 may be coupled to the outer body 402 of the motorized strut 400, and more particularly, may be coupled to the outer body 402 on the end or side opposite the telescoping portion (e.g., inner body 410).
  • the secondary telescoping member 450 may include a first coupling mechanism shown as, for example, a first joint 404 for coupling to the first platform.
  • the secondary telescoping member 450 is arranged and configured to be moveable relative to the outer body 402.
  • the secondary telescoping member 450 may be arranged and configured to be cylindrical and include an interior cavity 452 arranged and configured to receive at least a portion of the outer body 402.
  • the secondary telescoping member 450 may be moved (e.g., translate, slide, etc.) relative to the outer body 402 thereby enabling manual adjustment of the secondary telescoping member 450 relative to the outer body 402 and thus manual adjustment of the overall length of the motorized strut 400 as measured by the distance between the first and second coupling mechanisms shown as, for example, first and second joints 404, 412.
  • motorized strut may include any suitable coupling mechanisms now known or hereafter developed including, for example, first and second pin clamps or bar clamps for use in an external fixation system, as will be readily appreciated by one of ordinary skill in the art.
  • the position of the secondary telescoping member 450 may be selectively fixed by the user (e.g., surgeon) by any mechanism now known or hereafter developed.
  • the secondary telescoping member 450 may include a slot 454 formed therein and a bolt or fastener 456 received through the slot 454 and into engagement with the outer body 402.
  • rotation or tightening of the bolt 456 may selectively prevent movement of the secondary telescoping member 450 relative to the outer body 402 while rotation or loosening of the bolt 456 may selectively enable movement of the secondary telescoping member 450 relative to the outer body 402.
  • the slot 454 may be arranged and configured with grooves or serrations 458 across the slot 454 so that the bolt 456 can be tightened down into a threaded hole within the outer body 402 to hold the strut at length (e.g., the bolt 456 is arranged and configured to thread into the outer body 402 of the motorized strut 400, grooves or serrations 458 may be cut into the slot 454 of the outer body 402 along its length to allow tightening the bolt 456 down onto a clamping member that fits into the grooves or serrations 458 anywhere along the length of the slot 454).
  • the secondary telescoping member 450 can translate freely so that the strut length can be changed quickly in the operating room.
  • Geometric features may be incorporated into either the secondary telescoping member 450, the outer body 402, or both to constrain their translation relative to one another.
  • the secondary telescoping member 450 is arranged and configured to move (e.g., slide, translate, etc.) relative to the outer body 402 of the motorized strut 400. Thereafter, once properly positioned, the secondary telescoping member 450 may be fixedly coupled to the outer body 402 of the motorized strut 400 via, for example, the bolt 456.
  • alternate fastening mechanisms may be used to fixedly couple the secondary telescoping member 450 relative to the outer body 402 of the motorized strut 400.
  • a spring-loaded plunger may be used in place of the threaded bolt.
  • the spring-loaded plunger could be spring biased such that the clamping member is held engaged at all times unless the plunger is lifted.
  • a wedge-shaped tool may be used to lift and hold the plunger in a disengaged position to enable the secondary telescoping member 450 to translate relative to the outer body 402 of the motorized strut 400.
  • a locking collar could be utilized to fixedly couple the secondary telescoping member 450 to the outer body 402 of the motorized strut 400.
  • the locking collar could include a cam mechanism. In use, when disengaged or released, the diameter of the locking collar increases, allowing the secondary telescoping member 450 to move relative to the outer body 402 of the motorized strut 400. When the cam mechanism is engaged, the diameter would be tight around the outer body 402 thereby securing the relative position of the secondary telescoping member 450 to the outer body 402 of the motorized strut 400.
  • the locking collar could be rotatable (e.g., user rotates the locking collar to increase/decrease its relative diameter).
  • the motorized strut 500 may be used in a motorized spatial frame such as, for example, in place of motorized struts 200 in spatial frame 300 or in any other suitable motorized spatial frame, external fixation system, etc. now known or hereafter developed.
  • the motorized strut 500 may, in some examples, have a similar construction as motorized strut 200 previously described except as provided for herein.
  • motorized strut 500 may have any other suitable configuration.
  • the motorized strut 500 may include a multi-stage or dual stage lengthening mechanism arranged and configured to provide increased lengthening without increasing the minimum length of the motorized strut. That is, in use, the multistage or dual stage lengthening mechanism is arranged and configured to provide an increased working length, range, or throw by providing the motorized strut with an increased length in the fully extended position (FIG. 5C) without increasing the minimum length of the motorized strut in the fully retracted position (FIG. 5A).
  • the motorized strut 500 includes a first outer body 502 operatively coupled with a first coupling mechanism shown as, for example, a first joint 504 for coupling to a first platform, the first outer body 502 arranged and configured to house the motor 522, as will be described in greater detail below.
  • the motorized strut 500 also includes a second outer body 542 and a chassis 540, the chassis 540 arranged and configured to couple the second outer body 542 to the first outer body 502.
  • the motor 522 may be coupled to the chassis 540 to prevent rotation of the motor 522.
  • the motorized strut 500 may include an inner distraction rod or inner body 510 (terms used interchangeably herein without the intent to limit or distinguish) operatively coupled with a second coupling mechanism shown as, for example, a second joint 512 for coupling to a second platform, an outer distraction rod or body 515, and a drive mechanism 520 arranged and configured to move the inner and outer distraction rods 510, 515 relative to the second outer body 542 to adjust the length of the motorized strut 500.
  • a second coupling mechanism shown as, for example, a second joint 512 for coupling to a second platform
  • an outer distraction rod or body 515 an outer distraction rod or body 515
  • a drive mechanism 520 arranged and configured to move the inner and outer distraction rods 510, 515 relative to the second outer body 542 to adjust the length of the motorized strut 500.
  • the second outer body 542 may be arranged and configured to house at least portions of the inner and outer distractions rods 510, 515, and the multistage or dual-stage threaded rod assembly (e.g., inner and outer threaded rods 524A, 524B) when in the fully retracted position (FIG. 5A).
  • the multistage or dual-stage threaded rod assembly e.g., inner and outer threaded rods 524A, 524B
  • the drive mechanism 520 includes a motor 522 and a threaded rod or lead screw assembly 524 (e.g., a multi-stage or dual-stage threaded rod assembly as will be described in greater detail below) arranged and configured so that, in use, actuation of the motor 522 rotates the threaded rod or lead screw assembly 524, which moves the inner and outer distraction rods 510, 515 relative to each other and relative to the second outer body 542 to adjust an overall length of the motorized strut 500.
  • the drive mechanism 520 may include one or more gears to adjust speed and torque of the motor 522.
  • the outer distraction rod 515 is shown and described as being manufactured as a single, monolithic construction, it should be noted that the outer distraction rod 515 may be manufactured from first and second components since a flange may be incorporate at an end thereof.
  • the motorized strut 500 is arranged and configured with an in-line design, wherein the motor 522 shares a common longitudinal axis as the threaded rod 524 and the telescoping portions (e.g., inner and outer distraction rods 510, 515).
  • the motor 522 shares a common longitudinal axis as the threaded rod 524 and the telescoping portions (e.g., inner and outer distraction rods 510, 515).
  • the features of the present disclosure may be used in combination with motorized struts that have an off-axis design.
  • the motorized strut 500 includes a multi-stage or dual-stage threaded rod assembly 524. That is, the motorized strut 500 includes dual threaded rods 524A, 524B (e.g., the motorized strut 500 includes an inner threaded rod 524A and an outer threaded rod 524B).
  • the inner threaded rod 524A is operatively coupled to the motor 522 and includes external threads.
  • the outer threaded rod 524B includes internal and external threads.
  • the internal threads of the outer threaded rod 524B are arranged and configured to interface with the external threads of the inner threaded rod 524 A so that rotation of the inner threaded rod 524 A via the motor 522 results in movement of the outer threaded rod 524B relative to the inner threaded rod 524A.
  • the external threads of the outer threaded rod 524B are arranged and configured to interface with internal threads within the inner distraction rod 510.
  • the outer distraction rod 515 is devoid of any threads (e.g., the outer distraction rod 515 is not in threaded engagement with any other component, the outer distraction rod 515 is not in threaded engagement with the inner threaded rod 524A or the inner distraction rod 510).
  • the outer threaded rod 524B is threadably coupled to the inner threaded rod 524A and to the inner distraction rod 510 so that in use, as will be described in greater detail herein, rotation of the inner threaded rod 524A causes translation of the outer threaded rod 524B via their corresponding threads, and the inner distraction rod 510 via corresponding threads with the outer threaded rod 524B, and eventually translation of the outer distraction rod 515 (e.g., sufficient translation of the inner distraction rod 510 causes a portion of the inner distraction rod 510 to contact the outer distraction rod 515 causing the outer distraction rod 515 to translate in unison with the inner distraction 510).
  • the motor 522 drives the inner threaded rod 524A for all lengthening and/or shortening.
  • the inner threaded rod 524A interfaces with the outer threaded rod 524B, which interfaces with internal threads within the inner distraction rod 510.
  • actuation of the motor 522 rotates the inner threaded rod 524A and the outer threaded rod 524B together causing translation of the inner distraction rod 510 relative to the second outer body 542.
  • the inner distraction rod 510 includes only a few internal threads.
  • the inner distraction rod 510 may include between 5 and 10 threads, although more or less threads could be used.
  • the number and length of threads on the inner distraction rod 510 may be dependent on the thread pitch of the threads being utilized.
  • the internal threads of the inner distraction rod 510 are configured so that the total surface area of thread contact between the inner distraction rod 510 and the outer threaded rod 524B is less than the surface area of contact between the inner threaded rod 524A and the outer threaded rod 524B.
  • initial translation or lengthening occurs at the threaded interface between the outer threaded rod 524B and the inner distraction rod 510 (e.g., rotation from the motor 522 (e.g., the output shaft of the motor 522) rotates the inner threaded rod 524A, which rotates the outer threaded rod 524B causing the inner distraction rod 510 to move (e.g., translate) relative to the second outer body 542.
  • the inner threaded rod 524A and the outer threaded rod 524B rotate together while the inner distraction rod 510 does not rotate, which causes the inner distraction rod 510 to translate, resulting in lengthening of the motorized strut 500.
  • the inner distraction rod 510 and/or the outer distraction rod 515 is prevented from rotating via an anti-rotational mechanism such as, for example, corresponding flat surfaces, keyed surfaces, etc. as will be described in greater detail below.
  • the first stage of lengthening continues until a stop such as, for example, a flange 530 (FIGS. 7A-7C) on the inner distraction rod 510 contacts a stop such as, for example, a flange 531 (FIGS. 7B and 7C) formed at a first end of the outer distraction rod 515. Once contact occurs, continued rotation of the inner threaded rod
  • the outer distraction rod 515 via the motor 522 causes the outer distraction rod 515 to translate with the inner distraction rod 510 and the outer threaded rod 524B. As will be described in greater detail below, this occurs because, for example, a flange on the outer distraction rod 515 contacts or catches the outer threaded rod 524B and ensures it is pulled along, although other mechanisms for coupling the outer distraction rod and the outer threaded rod are envisioned.
  • the second stage of lengthening sees both the inner and outer distraction rods 510, 515 and the outer threaded rod 524B all translating as the inner threaded rod 524A continues to rotate via the motor 522.
  • the outer distraction rod 515 begins to translate (e.g., the inner distraction rod 510 pulls the outer distraction rod 515 along).
  • the outer distraction rod 515 contains no threads and thus is pulled/pushed by the corresponding flanges.
  • the outer distraction rod 515 is not subjected to axial loading, the load of weightbearing is transferred from the inner distraction rod 510 to the outer threaded rod 524B to the inner threaded rod 524 A.
  • the outer distraction rod 515 includes, for example, an internal flange 531 on both ends thereof (e.g., first and second flanges 531).
  • the inner distraction rod 510 includes an external flange 530.
  • the external flange 530 on the inner distraction rod 510 contacts the first flange 531 on the outer distraction rod 515 (e.g., the external flange 530 of the inner distraction rod 510 being positioned towards the right side of the inner distraction rod 510 in FIGS.
  • the first flange 531 on the outer distraction rod 515 positioned towards the left side of the outer distraction rod 515 in FIGS. 5A-5C, 7B, and 7C).
  • the inner distraction rod 510 cannot translate beyond contact with the outer distraction rod 515 thereby ensuring that the inner and outer distraction rods 510, 515 cannot decouple or separate.
  • contact of the flanges 530, 531 ensures that the outer distraction rod 515 translates with (e.g., is pulled by) the inner distraction rod 510.
  • the outer distraction rod 515 may include a second internal flange, positioned at the right side of the outer distraction rod 515 in FIGS. 5A-5C and 7C. In use, the second internal flange contacts or interacts with the outer threaded rod 524B.
  • the second flange contacts the outer threaded rod 524B and since the first flange 531 on the outer distraction rod 515 is being pulled by the inner distraction rod 510, the second flange on the outer distraction rod 515 begins to push on the outer threaded rod 524B causing the outer threaded rod 524B to no longer freely rotate with the inner threaded rod 524A thereby causing the outer threaded rod 524B to translate resulting in a second stage lengthening. This lengthening can continue until an external flange 532 of the outer distraction rod 515 contacts an internal flange 533 on the outer body (e.g., second outer body 542).
  • the motorized strut 500 incorporates an anti- rotational mechanism associated with the telescoping members (e.g., inner and outer distraction rods 510, 515).
  • the anti-rotational mechanism may be provided by incorporating flat surfaces or flats 513, 516 (FIGS.
  • the inner distraction rod 510 may include first and second parallel flats or flat surfaces 513 (FIGS. 7A-7C) cut into its outer diameter.
  • the outer distraction rod 515 may include first and second parallel flats or flat surfaces 516 (FIGS.
  • the outer body 502 may include first and second parallel flats or flat surfaces 517 (FIGS. 7A-7C) cut into its inner diameter.
  • the outer body 502 may be coupled to the chassis 540 of the motorized strut 500 so that the outer body 502 is prevented from rotating. Incorporation of the flat surfaces 513, 516, 517 prevent the distraction rods 510, 515 from rotating. Since rotation of these components cannot occur, as will be readily appreciated by one of ordinary skill in the art, translation occurs resulting in shortening/lengthening of the motorized strut 500 depending on the direction of rotation from the motor 522 and threaded rod assembly 524.
  • stops may have any suitable form now known or hereafter developed.
  • the stops could be provided in the form of set-screws or by any other means to keep the telescoping members (e.g., inner and outer distraction rods 510, 515) from lengthening to the point that they fully disengage from one another (no longer having any overlap).
  • a motorized strut is the elimination, or at least minimization, of errors associated with reading the strut lengths. That is, currently existing manually adjusted struts (e.g., non-motorized struts) with double telescoping functionality may incorporate dual scales for reading the length of the motorized strut. That is, currently, manually actuated struts utilizing double telescoping functionality incorporate a first scale to indicate the position of the outermost housing relative to the inner housing, while a second scale indicates the position of the adjustable threaded rod within the inner housing.
  • the motorized struts may be arranged and configured to monitor how much lengthening or shortening has occurred as treatment progresses and report these values back to the patient and/or health care provider via, for example, some wired or wireless communication through, for example, a smartphone or computer. Patients may still be instructed to monitor the position and/or length of the strut to ensure their struts are moving in the correct direction, but the usability risks associated with adjustments on double telescoping struts may be largely eliminated.
  • indicia other than numbers could be utilized.
  • the quick or manual adjustment mechanism could use letters while the threaded rod assembly could use numbers to reduce or minimize the risk of confusion.
  • the motorized strut is arranged and configured to provide increased lengthening from a given length of the strut (e.g., the motorized strut may have a smaller minimum length while providing an increased extended length and thus larger working range).
  • the motorized strut 500 may also include a quick adjustment mechanism.
  • the quick adjustment feature may be any suitable quick adjustment feature now known or hereafter developed.
  • the motorized strut 500 may incorporate the secondary telescoping member 450 as previously described. As illustrated, the secondary telescoping member 450 could be added to the non-lengthening side of the motorized strut 500 thereby facilitating quick intra-op length adjustment.
  • alternate quick adjustment features may be utilized including, for example, the quick adjustment mechanisms illustrated and described in International Patent Application No. PCT/US22/42863, filed on September 8, 2022, entitled “Quick Adjustment Mechanism for a Motorized Strut in a Spatial Frame.”
  • a key way feature could be added to one of the distraction rods 510, 515 that could be disengaged to allow rotation of the distraction rod, causing relatively quick manual lengthening or shortening.
  • a full thread disengagement design e.g., spring-loaded partially threaded jaws
  • the present examples have described one or more features for use in an in-line motorized strut, it is envisioned that the one or more features may be used in a motorized strut having an offset motor design (e.g., longitudinal axis of the motor is offset from the longitudinal axis of the threaded rod).
  • a secondary telescoping mechanism into a motorized strut having an offset motor design, the motorized strut could benefit from having a larger working length, meaning less strut changeouts and less inventory.
  • the present disclosure should not be limited to an in-line design unless specifically claimed.
  • the motorized struts serve to maximize the range (e.g., working range) of a motorized strut, and more preferably an in-line motorized strut.
  • range e.g., working range
  • an independent telescoping member allows quick, manual length adjustment in, for example, the operating room during initial setup, while not using any of the working length associated with rotation of the threaded rod.
  • incorporation of a two-stage telescoping design allows for essentially twice the working length of a motorized strut. If combined, a motorized strut having a larger working length (e.g., 2X working range) and the capability to be manually lengthened in the operating room without using any of the working length can be provided.
  • All directional references e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise
  • Connection references e.g., engaged, attached, coupled, connected, and joined
  • connection references are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. All rotational references describe relative movement between the various elements.

Abstract

Entretoise motorisée. Dans certains exemples, l'entretoise motorisée peut être utilisée dans un cadre spatial automatisé et/ou motorisé. En variante, l'entretoise motorisée peut être utilisée en tant que dispositif autonome dans, par exemple, un système de fixation externe. Dans chaque cas, l'entretoise motorisée peut comprendre un élément télescopique secondaire ou un composant de boîtier externe supplémentaire pour fournir un mécanisme de réglage manuel pour permettre à un chirurgien d'ajuster manuellement la longueur totale de l'entretoise motorisée sans nécessiter l'actionnement du moteur. De plus, et/ou en variante, l'entretoise motorisée peut comprendre un ensemble tige filetée à étages multiples ou à deux étages agencé et configuré pour fournir une plage de travail accrue sans augmenter sensiblement la longueur minimale de l'entretoise motorisée.
PCT/US2023/010393 2022-01-20 2023-01-09 Entretoise motorisée destinée à être utilisée dans un cadre spatial motorisé WO2023141032A1 (fr)

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