WO2024121848A1 - Dispositif, système et méthode de fixation d'os fracturés - Google Patents

Dispositif, système et méthode de fixation d'os fracturés Download PDF

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Publication number
WO2024121848A1
WO2024121848A1 PCT/IL2023/051245 IL2023051245W WO2024121848A1 WO 2024121848 A1 WO2024121848 A1 WO 2024121848A1 IL 2023051245 W IL2023051245 W IL 2023051245W WO 2024121848 A1 WO2024121848 A1 WO 2024121848A1
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WO
WIPO (PCT)
Prior art keywords
connector
bone
implant plate
aiming device
screw
Prior art date
Application number
PCT/IL2023/051245
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English (en)
Inventor
Roiy Jacob SALTI
Original Assignee
Medical Research & Development Fund for Health Services Bnai Zion Medical Center
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 Medical Research & Development Fund for Health Services Bnai Zion Medical Center filed Critical Medical Research & Development Fund for Health Services Bnai Zion Medical Center
Publication of WO2024121848A1 publication Critical patent/WO2024121848A1/fr

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Definitions

  • the present disclosure relates generally to device, system and method for fixation of bones, and, in particular, for fixation of long bone fractures and proximal femoral fractures.
  • Bone fraction fixation is a method for stabilization and support of injured or fractured bones, aimed to facilitate healing and restore the function and mobility thereof.
  • Bone fraction fixation typically includes external or internal fixation methods.
  • the internal fixation technique includes aligning and fixating the fractured bone by using various means, such as implant plates, screws, wires, pins, nails, rods and the like.
  • One of the promising internal fixation methods is the percutaneous compression plating (PCCP).
  • PCCP method is a minimally invasive technique which reduces blood loss and haematomas, minimizes soft tissue damage, thereby minimizing the recovery time.
  • the PCCP method is of a particular importance in elderly subjects.
  • currently implemented PCCP method requires experienced personnel accustomed performing such procedure in order to reduce the relative long operation time and avoid increasing the invasiveness of the surgery.
  • systems, devices and methods for fixation of bones including, long bone fractures and proximal femoral fractures, which are minimally invasive, cost efficient, safe and customizable.
  • the systems, devices and methods disclosed herein allow implanting a bone-connector plate in a relatively simple, fast and safe manner, with minimal surgical intervention.
  • devices, systems and methods and kits for fixation of a bone are provided herein.
  • the disclosed devices, systems and methods reduce occurrence of complications during and after the medical procedure, thereby facilitating healing, and reducing rehabilitation and recovery time of a subject by reducing nonunion and/or malunion (i.e., healing in improper position) of the bone segments/fractures.
  • the disclosed devices, systems and methods teach a modified PCCP method for fixation of fractures bones, thereby reducing the medical procedure time.
  • the disclosed devices, systems and methods require no or minimal modification to the currently implemented PCCP implant plate, thereby increasing the applicability thereof.
  • the disclosed herein methods, devices and systems for fractured bone fixation include a simplified PCCP method, thereby reducing the learning time of the medical personal required for learning and practicing the procedure, thereby increasing the costeffectiveness of the procedure.
  • a detachable aiming device for fixation of a fractured bone
  • the aiming device includes a shaft, the shaft including: a distal portion including an alignment mechanism configured to align the aiming device with a first surface of a connector/implant plate, a proximal portion including a grip bar, and a first and a second angular sleeve extending from a first and a second opening of the shaft, respectively, the first and the second angular sleeves are configured to facilitate introducing a first and a second neck screw into the fractured bone through the connector/implant plate, thereby attaching a second surface of the connector plate to the fractured bone.
  • the distal portion of the shaft includes a distal opening
  • the proximal portion of the shaft includes a proximal opening, thereby defining a lumen extending along a longitudinal axis of the shaft.
  • the device may further include an alignment screw and/or an alignment pin corresponding to an opening and/or grooves of the connector/implant plate.
  • the alignment pin may be concave, so as to to facilitate engaging with a corresponding groove of the connector/implant plate.
  • the alignment screw is configured to be inserted via the lumen of the aiming device.
  • the proximal portion of the shaft may include a reinforcement bar.
  • an angle between each of the first and the second angular sleeves and the shaft may be about 135°.
  • an angle between each of the first and the second angular sleeves and the shaft may be about 130°.
  • the fractured bone may be a long bone.
  • the fractured bone may include proximal femoral fractures.
  • the fractured bone the fractured bone may include one or more bone fragments.
  • a kit for fixation of a fractured bone including: a first and a second screw-in drill sleeve configured to be inserted into a first and a second angular sleeve of an aiming device, respectively, a first and a second guide wires configured to guide drilling through the first and the second angular sleeves, a first and a second drill bit configured for drilling over the first and the second guide wires, a first and a second neck screw, configured to be inserted through the first and the second drill bits, thereby allowing inserting the first and the second neck screws through the aiming device and the connector/implant plate and into the fractured bone, and a screwdriver configured for locking the first and the second neck screws.
  • the kit may include a locking screw and a cortical screw configured to secure a connector/implant plate to the fractured bone of a subject, wherein the locking and the cortical screws are configured to be introduced via one or more corresponding drill sleeves.
  • the kit may include an alignment screw, configured to align the aiming device with the connector/implant plate.
  • the first and the second guide wires may be Kirschner wires.
  • a system for fixation of a broken/injured bone includes an aiming device and a connector/implant plate
  • the connector/implant plate includes: a first surface configured to face the aiming device, a second surface configured to be attached to the broken/injured bone, a distal portion including a sharpened end configured to be percutaneously inserted into a subject, a proximal portion configured to contour with the bone, a plurality of locking holes extending between the first surface and the second surface configured to receive a cortical screw and a locking screw configured to fixate the distal portion of the connector/implant plate to the fractured bone, and a first hole and a second hole extending between the first surface and the second surface configured to receive a first and a second neck screws, the first and the second neck screws are configured to fixate the proximal portion of the connector/implant plate to the bone.
  • the connector/implant plate may be a PCCP plate.
  • a kit for fixation of a fractured bone including: a first and a second screw-in drill sleeve configured to be inserted into a first and a second angular sleeve of an aiming device, respectively, a first and a second guide wires configured to guide drilling through the first and the second angular sleeves, a first and a second drill bit configured for drilling over the first and the second guide wires, a first and a second neck screw, configured to be inserted through a first and a second channels formed by the first and the second drill bits, thereby allowing inserting the first and the second neck screws through the aiming device and the connector/implant plate and into the fractured bone, a screwdriver configured for locking the first and the second neck screws.
  • the kit may include a locking screw and a cortical screw configured to secure a connector/implant plate to a bone of a subject, wherein the locking screw includes one or more drill sleeves configured for introducing and locking the locking screw and the cortical screw into the fractured bone.
  • the first and the second guide wires are Kirschner wires (K-wires).
  • a system for fixation of a broken bone the system includes the disclosed aiming device and the disclosed kit.
  • a method for fixation of a fractured bone of a subject including aligning and associating an aiming device with a first surface of a connector/implant plate, wherein the first surface is configured to face the aiming device; introducing the connector/implant plate associated with the aiming device into the subject via a skin incision, such that a second surface of the connector/implant plate faces the bone; positioning, under medical imaging, the connector/implant plate in a suitable anatomical location, such that the plate contacts the bone at the fraction region, wherein the positioning is facilitated using the aiming device; performing fixation of the connector/implant plate to a bone of a subject, using one or more screws inserted through corresponding openings in the aiming device; detaching/removing the aiming device from the connector/implant plate; and closing the skin incision.
  • aligning may include inserting a first and a second screw-in drill sleeves into a first and a second angular sleeves of the aiming device, respectively.
  • aligning may include inserting an anchoring screw via a shaft of the aiming device.
  • the intraoperative medical imaging may include fluoroscopy.
  • the fluoroscopy may include antero-posterior, true lateral and oblique views.
  • Figure 1 schematically illustrates a cross-sectional side view of a connector/implant plate, according to some embodiments
  • Figure 2A schematically illustrates a cross-sectional side view of an aiming device, according to some embodiments, according to some embodiments;
  • Figure 2B schematically illustrates a cross-sectional side view the aiming device of Figure 2A attached to a connector/implant plate, according to some embodiments;
  • Figure 3 schematically illustrates a surgical instruments kit used for fixation of a fractured bone, according to some embodiments
  • Figure 4 shows a flowchart of a method for fixation of a fractured bone of a subject, according to some embodiments.
  • FIGS 5A-5I schematically illustrate a system for fixation of a fractured bone, during various steps/stages of the method of Figure 4, according to some embodiments.
  • the words “include” and “have”, and forms thereof, are not limited to members in a list with which the words may be associated.
  • the term “about” may be used to specify a value of a quantity or parameter (e.g., the length of an element) to within a continuous range of values in the neighborhood of (and including) a given (stated) value. According to some embodiments, “about” may specify the value of a parameter to be between 80 % and 120 % of the given value. For example, the statement “the length of the element is equal to about 1 m” is equivalent to the statement “the length of the element is between 0.8 m and 1.2 m”. According to some embodiments, “about” may specify the value of a parameter to be between 90% and 110% of the given value. According to some embodiments, “about” may specify the value of a parameter to be between 95% and 105% of the given value.
  • the terms “substantially” and “about” may be interchangeable.
  • the disclosed devices, systems and methods may be used for treating a long bone fracture.
  • the disclosed devices, systems and methods may be used for treating proximal femoral fractures with an intact lateral wall.
  • the fractures may include pertrochanteric femoral fractures.
  • the fractures may include intertrochanteric hip fractures.
  • the disclosed devices, systems and methods simplify and improve currently implemented operative methods of treating fractured bones by minimally invasive techniques.
  • the disclosed devices, systems and methods reduce occurrence of complications during and after the medical procedure, thereby facilitating healing, and reducing rehabilitation and recovery time of a subject by reducing nonunion and/or malunion (i.e., healing in improper position) of the bone segments/fractures.
  • the disclosed devices, systems and methods teach a modified PCCP method for fixation of fractures bones, thereby reducing the medical procedure time.
  • the disclosed devices, systems and methods require no or minimal modification to the currently implemented PCCP implant plate, thereby increasing the applicability thereof.
  • the disclosed herein method, device and system for fractured bone fixation include a simplified PCCP method, thereby reducing the learning time of the medical personal required for learning and practicing the procedure, thereby reducing time and increasing the cost-effectiveness of the procedure.
  • an aiming device configured to facilitate attaching a connector/implant plate to a bone and securing the connector/implant plate by inserting a corresponding set of screws into the bone, such as described in greater detail elsewhere herein.
  • the device facilitates properly assessing the position and orientation of the set of screws, while simplifying the operative method.
  • the aiming device may be used with a plurality of surgical approaches.
  • the aiming device may be used in a percutaneous surgical approach, wherein a small skin incision is performed for inserting/implanting a connector plate.
  • the aiming device may be used in a percutaneous compression plating (PCCP) for intra-operative fixation of fractures, such as, among others, long bone fractures and proximal femoral fractures.
  • PCCP percutaneous compression plating
  • the aiming device is detachably coupled to a connector/implant plate.
  • FIG. 1 schematically illustrates a cross-sectional side view of a connector/implant plate 100, according to some embodiments.
  • connector/implant plate 100 is configured to be attached to a fractured/injured bone of a subject.
  • connector/implant plate 100 may be similar or identical to a standard PCCP plate.
  • connector/implant plate 100 may include a modification of the previous PCCP plate.
  • connector/implant plate 100 includes a distal portion 112, a proximal portion 114, a first surface 116, and a second surface 118.
  • second surface 118 is configured to be attached to the bone.
  • distal portion 112 is configured to penetrate a soft tissue covering the bone surface.
  • distal portion 112 of the connector/implant plate 100 may include a sharpened end 122 to facilitate penetrating the soft tissue through a small skin incision.
  • distal portion 112 may include an angular structure. As a non-limiting example, distal portion 112 may include a beveled end to facilitate penetrating the soft tissue.
  • proximal portion 114 of the connector/implant plate 100 includes an angular/bent portion 120 to conform to a contour of the bone surface/structure.
  • second surface 118 is configured to conform to the contour of the bone surface/structure.
  • the bone surface/structure may include one or more bone segments/fractures.
  • second surface 118 may include a two-dimensional structure to conform to the contour of the bone surface/structure.
  • second surface 118 may include a three-dimensional structure to conform to the contour of the bone surface/structure.
  • second surface 118 may include a varying topography to conform to the contour of the bone surface/structure.
  • the topography may include, among others, different protuberances or grooves across the bone, angular displacements, and the like, or any combination thereof.
  • second surface 118 may include geometrically complementary grooves and/or protuberances.
  • connector/implant plate 100 is made of or includes biocompatible materials. According to some embodiments, connector/implant plate 100 may include radiopaque materials. According to some embodiments, connector/implant plate 100 may be made of or include, among others, metals (e.g., titanium), alloys (e.g., stainless steel, nitinol, aluminum alloys), composite materials (e.g., carbon fiber composites), polymers, or any combination thereof. Each possibility is a separate embodiment.
  • connector/implant plate 100 includes a plurality of holes extending between first surface 116 and second surface 118.
  • the plurality of holes may include two types of holes.
  • the plurality of holes may include three types of holes. Each possibility is a separate embodiment.
  • the plurality of holes may include a first and a second plurality of holes.
  • the first plurality of holes includes a first tapered hole 102 sized to receive a first screw-in drill sleeve and a first neck screw, and a second tapered hole 104 sized to receive a second screw-in drill sleeve and a second neck screw, as described in FIG. 3.
  • first and second tapered holes 102 and 104 may point in a parallel direction.
  • first and second tapered holes 102 and 104 may extend through first and second surfaces 116 and 118 at an angle of about 130°.
  • first and second tapered holes 102 and 104 may extend through first and second surfaces 116 and 118 at an angle of about 135°.
  • Each possibility is a separate embodiment.
  • the second plurality of holes includes a plurality of cortical/locking holes 106, 108 and 110 sized to receive a locking screw and cortical screw, as described in greater detail elsewhere herein.
  • the second plurality of holes includes two cortical holes (e.g., cortical/locking holes 106, 108).
  • the second plurality of holes includes three cortical holes.
  • the second plurality of holes includes four cortical holes.
  • the number of the second plurality of holes may vary. Each possibility is a separate embodiment.
  • cortical/locking hole 110 is configured to receive an alignment/anchoring screw administered therein through a guiding sleeve of an aiming device, e.g., as depicted in FIG. 2A and FIG. 2B.
  • connector/implant plate 100 includes a groove (not shown) sized to receive an alignment mechanism of the aiming device (e.g., as further depicted in FIG. 2A), configured to align the aiming device with connector/implant plate 100.
  • FIG. 2A schematically illustrates a cross-sectional side view of an aiming device 200
  • FIG. 2B schematically illustrates aiming device 200 attached to a connector/implant plate 250, according to some embodiments.
  • aiming device 200 includes a shaft 202 having a distal portion 212 and a proximal portion 214.
  • distal portion 212 is configured to be detachably attached to connector/implant plate 250.
  • connector/implant plate 250 may be identical, similar or different from the disclosed connector/implant plate 100 in FIG. 1. Each possibility is a separate embodiment.
  • shaft 202 includes a first angular sleeve 222 extending from a first opening 226a, and a second angular sleeve 224 extending from a second opening 228a.
  • first and second angular sleeves 222 and 224 configured to guide a first and a second neck screw (e.g., as depicted in FIG. 3), respectively, through aiming device 200, through connector/implant plate 250 and into a fractured bone of a subject.
  • first and second angular sleeves 222 and 224 are configured to define an angle of insertion of each of the first and second neck screws into the bone of the subject, thereby facilitating accurately positioning thereof.
  • the angle of insertion may be about 130°.
  • the angle of insertion may be about 135°.
  • first and second angular sleeves 222 and 224 may be designed to facilitate deployment of the first and the second neck screws into the fractured bone.
  • the first neck screw in operation, is inserted into first opening 226a of first angular sleeve 222, exits from a first exit hole 226b, passes through a first tapered hole (e.g., first tapered hole 102 of connector/implant plate 100, as depicted in FIG. 1) and penetrates into a bone of a subject at a predefined insertion angle dictated by the aiming device 200.
  • a first tapered hole e.g., first tapered hole 102 of connector/implant plate 100, as depicted in FIG.
  • the second neck screw is inserted into second opening 228a of second angular sleeve 224, exits from a second exit hole 228b, passes through a second tapered hole (e.g., second tapered hole 104 of connector/implant plate 100, as depicted in FIG. 1) and penetrates a bone of a subject at a predefined insertion angle dictated by the aiming device 200.
  • a second tapered hole e.g., second tapered hole 104 of connector/implant plate 100, as depicted in FIG. 1
  • first exit hole 226b of first angular sleeve 222 may be geometrically complementary with the first tapered hole of the connector/implant device.
  • second exit hole 228b of second angular sleeve 224 may be geometrically complementary with the second tapered hole of the connector/implant device.
  • proximal portion 214 of shaft 202 includes a grip bar 208 configured to facilitate gripping of aiming device 200.
  • grip bar 208 may be perpendicular to shaft 202. Alternatively, or additionally, in some embodiments, grip bar 208 may include an angular structure.
  • proximal portion 214 includes a reinforcement bar 210a/210b.
  • the structure and size of the reinforcement bar 210a/210b may vary.
  • reinforcement bar 210a/210b may include a bent, circular, semi-circular, oval, conus-line, rectangular, or any other structure.
  • reinforcement bar 210a/210b may include an angled structure. Each possibility is a separate embodiment.
  • shaft 202 includes an alignment mechanism 230 configured to align the aiming device 200 with connector/implant plate 250.
  • alignment mechanism 230 optionally includes an alignment pin 232 geometrically complementary with a groove (not shown) of connector/implant plate 250.
  • alignment pin 232 may include a concave distal end (not shown) to facilitate engaging with connector/implant plate 250.
  • alignment mechanism 230 may include various locking mechanisms, such as but not limited to, mechanical quick release mechanisms, configured to detachably attach aiming device 250 to connector/implant plate 250.
  • alignment mechanism 230 may include one or more circumferential teeth (e.g., mounted in vicinity to a distal opening 206) and a plurality of corresponding slots (e.g., formed on connector/implant plate 250), thereby allowing coupling aiming device 200 with connector/implant plate 250.
  • the plurality of teeth may be asymmetrically positioned and/or differ, e.g., in size, structure, orientation, and the like, such that each of the plurality of teeth may be inserted into each of the plurality of slots, allowing coupling at a preferred orientation only.
  • alignment mechanism 230 may include positioning a first and a second screw-in drill sleeves (as further elaborated elsewhere herein) via first and second angular sleeves 222 and 224 and into connector/implant plate.
  • shaft 202 may optionally include a proximal opening 204 and a distal opening 206 defining a guiding sleeve extending across a longitudinal axis of the shaft (i.e., extending between proximal opening 204 and distal opening 206).
  • the guiding sleeve may be cannulated.
  • proximal opening 204 is configured to receive a screwdriver (e.g., as further depicted in FIG. 3) therethrough and into distal opening 206 configured to operate an alignment/anchoring screw 218.
  • the guiding sleeve may be designed to receive alignment/anchoring screw 218 configured to facilitate securing aiming device 200 to connector/implant plate 250.
  • a secured configuration 240 of alignment/anchoring screw 218 includes at least partially positioning thereof into a respective groove of connector/implant plate 250.
  • kit 300 includes a first and a second screw-in drill sleeve 302a and 302b configured to be inserted into a first and a second angular sleeve of an aiming device (e.g., as further depicted in FIG. 6), respectively.
  • the first screw-in drill sleeve 302a may be identical, similar or different from the second screw-in drill sleeve 302a. Each possibility is a separate embodiment.
  • first and second screw-in drill sleeves 302a and 302b may be cannulated.
  • each of first and second screw-in drill sleeves 302a and 302b may be in a form of centred screw-in drill sleeves used for each of a first and a second neck screws 312a and 312b.
  • first and second neck screws 312a and 312b are configured to be inserted into the fractured bone of the subject.
  • the first neck screw 312a may be identical, similar or different from the second neck screw 312b. Each possibility is a separate embodiment.
  • kit 300 includes a first and a second Kirschner wire (K- wire) 304a and 304b.
  • first Kirschner wire 304a may be identical, similar or different from second Kirschner wire 304b.
  • first and second Kirschner wires 304a and 304b are configured to guide drilling through first and second screw-in drill sleeves 302a and 302b.
  • first and second Kirschner wires 304a and 304b may be smooth.
  • kit 300 includes a first and a second drill bit 306a and 306b.
  • the first drill bit 306a may be identical, similar or different from the second drill bit 306a.
  • drill bits 306a and 306b may be canulated.
  • each of drill bits 306a and 306b is sized to form holes geometrically complementary with the size of each of first and second neck screws 312a and 312b.
  • kit 300 includes one or more drill sleeves (not depicted) adapted for a locking screw 308a and/or for a cortical screw 308b.
  • the one or more drill sleeves designed for introducing locking screw 308a include a first drill sleeve.
  • the first drill sleeve may be in a form of a trocar configured for penetrating tissue.
  • the one or more drill sleeves may include a first drill bit configured for introducing locking screw 308a.
  • the one or more drill sleeves may include a torque screwdriver configured for locking and securing locking screw 308 into a bone through a connector/implant plate.
  • the first drill sleeve may be used for introducing cortical screw 308b.
  • the one or more drill sleeves may include a second drill sleeve configured for introduction of cortical screw 308b.
  • the first drill bit may also be used for introducing cortical screw 308b.
  • the one or more drill sleeves may include a second drill bit configured for introduction of cortical screw 308b.
  • the torque screwdriver is not required for securing cortical screw 308b.
  • locking screw 308a and/or cortical screw 308b are introduced into the bone by screwing thereof with a hexagonal screwdriver (e.g., screwdriver 314, as elaborated elsewhere herein).
  • a hexagonal screwdriver e.g., screwdriver 314, as elaborated elsewhere herein.
  • each of the one or more drill sleeves may be grouped in a combined form, such that in operation, each of the components of the one or more drill sleeves is pulled/removed therefrom, according to predefined order of the performed step.
  • locking screw 308a includes one or more locking screws configured to be inserted into the bone of the subject through connector/implant plate 250.
  • cortical screw 308b includes one or more cortical screws configured to be inserted into the bone of the subject through connector/implant plate 250.
  • kit 300 includes a screwdriver 314 having a grip 317.
  • screwdriver 314 may be a designated screwdriver.
  • screwdriver 314 may be a cannulated screwdriver.
  • screwdriver 314 may include a hexagonal end 315 adapted to engage with a first bore of first neck screw 312a and with a second bore of second screw neck 312b, thereby allowing rotation of first neck screw 312a and second neck screw 312b by rotating grip 317.
  • screwdriver 314 may be used for locking and securing an alignment/anchoring screw (e.g., as depicted in FIG. 2A and FIG. 2B).
  • screwdriver 314 is used for locking and securing locking screw 308a and cortical screw 308b.
  • each component of kit 300 may include different designs (e.g., size, form, composition, and the like) based, among others, on the type of the fractured bone, the bone fractures/segments, the surgical indications, and the like, or any combination thereof.
  • kit 300 may be disposable.
  • kit 300 may be partially reusable (e.g., screwdriver 314) and partially disposable (e.g., include single use components, such as neck screw with are inserted into the bone).
  • the reusable portion of kit 300 may be sterizable.
  • FIG. 4 is a flowchart 400 of an operative method for fixation of a fractured bone of a subject, according to some embodiments, as well as to FIGs. 5A-5I which illustratively depict certain steps of the operative method. It is understood by one of ordinary skill in the art that the steps, as outlined below, may not necessarily be carried out in the indicated order. The order of at least some of the steps may be changed or be carried out simultaneously, as readily understood by one of ordinary skill in the art. It may further be understood that at least one of the steps may be carried out separately from the procedure (e.g., the day before).
  • the following components depicted in FIGs. 5A-I including components 500, 550, 502a, 502b, 504a, 504b, 506a, 506b, 508a, 508b, 512a, 512b correspond to and may have the same structure and configuration as the previously described components 200, 250, 302a, 302b, 304a, 304b, 306a, 306b, 308a, 308b, 312a, 312b.
  • surgical planning is performed in order to properly assess the state of a fractured bone (e.g., a bone 501 as depicted in FIGs. 5A-I) of a subject.
  • the surgical planning may include characterizing the fractured bone (e.g., fractures size, number of the fractures, position/orientation of fractures/bone segments, and the like).
  • the surgical planning may include imaging (such as but not limited to X-ray imaging) of the fractured bone.
  • the surgical planning may include assessment of surgical indications.
  • the surgical indications may include, among others, assessing the state of a lateral trochanteric wall of the bone, thereby enabling tailoring a connector/implant plate and/or an aiming device for the bone of the subject.
  • the surgical indications may include assessing a per-trochanteric fracture (e.g., stable or unstable fracture).
  • the surgical indications may include assessing/characterizing a base of a neck fracture.
  • the surgical indications may include assessing/characterizing trans-cervical fractures.
  • the surgical indications may include assessing/characterizing an inter-trochanteric fracture.
  • the inter- trochanteric fracture may include an intact lateral wall.
  • the surgical indications may include assessing a stable sub-capital fracture, e.g., in adults up to 60 years of age.
  • the surgical planning may include measuring the lateral wall thickness in intertrochanteric fractures.
  • the surgical planning may include designing a patient- specific connector/implant plate, based, at least partially, on the surgical indications.
  • the disclosed herein aiming device, kit, and system for fixation of a fractured bone may include different dimensions, structures, and/or combination of components.
  • the subject may be positioned on a fracture table, according to some embodiments.
  • the subject is positioned such that an injured limb patella is facing the sky (i.e., upwards).
  • an anatomical reduction is achieved, to facilitate healing and promote correct function of the fractured bone, according to some embodiments.
  • the anatomical reduction may include repositioning and aligning segments/fragments of the fractured bone.
  • the anatomical reduction may include repositioning and aligning segments/fragments of the fractured bone according to their natural/normal alignment.
  • the anatomical reduction may be performed under live fluoroscopy, such as in antero-posterior (AP), true lateral, and oblique studies/views/images.
  • AP tero-posterior
  • a surgeon must achieve an acceptable anatomical reduction of the fracture, namely posterior sagging is unacceptable.
  • a calcar-referenced tip apex distance (CalTAD) value of less than about 20 mm may be needed for the prevention of implant "cut-out”.
  • a posterior reduction device may be optionally used to prevent the posterior sagging.
  • a first skin incision is performed in a target area/anatomical location of the subject, according to some embodiments.
  • the incision is performed under medical imaging, such as but not limited to fluoroscopy.
  • step 408 includes drawing anatomical skin marks on the target area/anatomical location under fluoroscopy control.
  • the skin marks may include a first oblique line drawn 2 mm proximal and parallel to the calcar femoral drawn under an AP view, and a second line drawn under a true lateral view, such that the second line is in line with the femoral shaft.
  • step 408 includes making a skin incision of about 5 cm, such that the approximate middle of the incision includes a crossing point of the anatomical skin marks.
  • step 408 includes making a skin incision of about 6 cm, such that the approximate middle of the incision includes a crossing point of the anatomical skin marks.
  • step 408 includes making a skin incision of about 5 to 6 cm, such that the approximate middle of the incision includes a crossing point of the anatomical skin marks.
  • step 408 includes dissecting the tensor fasciae latae (TFL) by using scissors followed by introducing the plate under the TFL, by using a distal sharp pole (e.g., sharpened end 122 as depicted in FIG. 1) of the connector/implant plate for a blunt dissection of the vastus lateralis until the connector/implant plate is approximated to the posterior lateral aspect of the proximal femur.
  • a distal sharp pole e.g., sharpened end 122 as depicted in FIG. 1
  • stripping of the periosteum (not shown) that covers an outer surface of fractured bone 501 may not be required.
  • step 410 a connector/implant plate associated with the aiming device is introduced into the subject, according to some embodiments.
  • step 410 includes attaching the connector/implant plate to an aiming device, as schematically illustrated in FIG. 5A.
  • the connector/implant plate may be attached to a 130° aiming device (i.e., an aiming device wherein the angle between each of angular sleeves and a shaft is about 130°).
  • the connector/implant plate may be attached to a 135° aiming device (i.e., an aiming device wherein the angle between each of angular sleeves and a shaft is about 135°).
  • step 410 includes inserting a first and a second screw- in drill sleeve (e.g., a first and a second screw-in drill sleeve 502a and 502b, as depicted in FIG. 6) through a first and a second opening of aiming device 500 and into a first and a second tapered hole of connector/implant plate 550, forming an assembled/single construction.
  • a first and a second screw- in drill sleeve e.g., a first and a second screw-in drill sleeve 502a and 502b, as depicted in FIG. 6
  • step 410 may optionally include connecting a distal locking sleeve to the most distal hole of connector/implant plate 550.
  • step 410 includes aligning the aiming device with a first surface of the connector/implant plate.
  • step 410 includes aligning of the first and the second screw-in drill sleeves with the first and the second tapered holes of the connector/implant plate.
  • the alignment may be performed by an alignment mechanism (e.g., alignment mechanism 230, as depicted in FIG. 2A and FIG. 2B).
  • the alignment mechanism may include any mechanical mechanism configured to align, and optionally secure, the first and second screw-in drill sleeves with the first and the second tapered holes of the connector/implant plate, respectively.
  • the alignment mechanism may include a quick connection/alignment mechanism.
  • the alignment mechanism may include an alignment pin configured to be secured in a geometrically complementary groove of the connector/implant plate.
  • the alignment mechanism may include one or more teeth (e.g., mounted on shaft of the aiming device) and one or more of corresponding slots (e.g., formed on the connector/implant plate), thereby allowing aligning, and optionally coupling, the aiming device with the connector/implant plate at a preferred orientation.
  • the alignment mechanism may include a snap fit mechanism.
  • the alignment mechanism may include positioning (e.g., screwing) a first and a second screw-in drill sleeves via a first and a second angular sleeve of the aiming device and into the connector/implant plate.
  • step 410 no skin incision is performed in step 410.
  • step 410 does not include performing a second skin incision.
  • a second skin incision may be performed.
  • the length of the second skin incision depends on the connector/implant plate size, locking screw hole location and fracture height.
  • the length of the second skin incision may be about 1 cm (for distal locking screw access).
  • the length of the second skin incision may be in the approximate range of 1 cm to 42 cm from the proximal portion of the connector/implant plate.
  • the length of the second skin incision is in the approximate range of 1 cm to 2 cm. Each possibly is separate embodiment.
  • the second skin incision is performed according to the anatomical skin marks of the subject.
  • the second skin incision includes dissecting the subcutaneous tissue, the TFL and muscles to expose about 1/3 of the proximal portion of the lateral femur.
  • step 410 includes positioning the attached/aligned connector/implant plate and the aiming device into the correct anatomical location under medical imaging (e.g., live imaging).
  • the medical imaging may include, among others, fluoroscopy (e.g., AP, true lateral and oblique studies/views), as depicted in FIG. 5B.
  • minor manual adjustments may be performed to facilitate placing the attached connector/implant plate and the aiming device into the correct anatomical location.
  • a transparent template may be utilized to facilitate positioning of the attached/aligned connector/implant plate and the aiming device into the correct anatomical location.
  • step 412 an initial fixation of the connector/implant plate is performed, according to some embodiments.
  • the initial fixation is performed under fluoroscopy.
  • step 412 includes positioning a second (distal) Kirschner wire 504b through second screw-in drill sleeve 502b.
  • step 412 includes drilling, by using a power tool, under the guidance of second Kirschner wire 504b through the second screw-in drill sleeve 502b until subchondral bone of the femoral head of bone 501 is reached.
  • step 412 includes positioning a first (proximal) Kirschner wire 504a and drilling through a first screw-in drill sleeve 502a until the subchondral bone of the femoral head is reached, as depicted in FIG. 5C.
  • step 412 includes maintaining a good tip apex distance.
  • a definitive fixation of the connector/implant plate is performed, according to some embodiments.
  • the definitive fixation is performed medical imaging, such as but not limited to under fluoroscopy.
  • step 414 includes forming a distal bone neck channel configured to house a second (distal) neck screw 512b.
  • the distal bone neck channel is formed by using a second drill bit 506b with a power tool and drilling over second Kirschner wire 504b, as depicted in FIG. 5D.
  • second (distal) neck screw 512b is fixated to the connector/implant plate by using a screwdriver (e.g., as depicted in FIG. 3).
  • second Kirschner wire 504b is used to facilitate guiding second neck screw 512b through aiming device 500, through connector/implant plate 550 and into bone 501, as depicted in FIG. 5E.
  • the alignment of connector/implant plate 550 with the femur shaft of bone 501 may be verified.
  • the alignment of connector/implant plate 550 with the femur shaft may be verified under medical imaging, such as but not limited to fluoroscopy.
  • drilling and positioning locking and/or cortical screw(s) is performed to fixate a distal portion of connector/implant plate 550 to bone 501.
  • the locking screw may include three locking screws.
  • a proximal portion of connector/implant plate 550 may be completed before fixating the distal portion thereof.
  • step 414 further includes forming a proximal bone neck channel configured to house a first (proximal) neck screw 512a.
  • the proximal bone neck channel is formed by using a first drill bit 506a with a power tool and drilling over first Kirschner wire 504a, as depicted in FIG. 5F.
  • first (proximal) neck screw 512a is fixated to connector/implant plate 550 by using the screwdriver (e.g., as depicted in FIG. 3).
  • first Kirschner wire 504a is used to facilitate guiding first neck screw 512a through aiming device 500, through connector/implant plate 550 and into bone 501, as depicted in FIG. 5G and FIG. 5H.
  • aiming device 500 is detached from connector/implant plate 500, according to some embodiments and as illustrated in FIG. 51. According to some embodiments, aiming device 500 may be detached from connector/implant plate 500 be releasing the alignment mechanism.
  • step 418 suturing the TFL and the corresponding subcutaneous and skin is performed.
  • the suturing is performed such that essentially no “dead” space is left within the subject.
  • the method may further include post operative observations and medical examinations.
  • full weight bearing e.g., on the operated limb of the subject
  • full weight bearing may be allowed.
  • aiming device 500 is made of or includes biocompatible materials.
  • connector/implant plate 100 may include radiopaque materials.
  • connector/implant plate 100 may be made of or include, among others, metals (e.g., titanium), alloys (e.g., stainless steel, nitinol, aluminum alloys), composite materials (e.g., carbon fiber composites), polymers, or any combination thereof. Each possibility is a separate embodiment.
  • aiming device 500 may be disposable (i.e., disposed following a single medical procedure). Alternatively, in some embodiments, aiming device 500 may be reusable. Put differently, aiming device 500 may be used in several medical procedures. According to some embodiments, aiming device 500 may be sterilizable.
  • stages of methods may be described in a specific sequence, the methods of the disclosure may include some or all of the described stages carried out in a different order.
  • the order of stages and sub-stages of any of the described methods may be reordered unless the context clearly dictates otherwise, for example, when a later stage requires as input and output of a former stage or when a later stage requires a product of a former stage.
  • a method of the disclosure may include a few of the stages described or all of the stages described. No particular stage in a disclosed method is to be considered an essential stage of that method, unless explicitly specified as such.

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  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de visée détachable pour la fixation d'un os fracturé, le dispositif de visée comprenant une tige dont la partie distale comporte un mécanisme d'alignement configuré pour aligner le dispositif de visée avec une première surface d'une plaque de raccord/d'implant, une partie proximale comportant une barre de préhension, et des premier et second manchons angulaires s'étendant respectivement à partir d'une première et d'une seconde ouverture de la tige, configurés pour faciliter l'introduction d'une première et d'une seconde vis à col dans l'os fracturé à travers la plaque de raccord/d'implant, attachant ainsi une seconde surface de la plaque de raccord à l'os fracturé. L'invention concerne en outre des systèmes et des trousses comprenant le dispositif de visée, ainsi que leurs méthodes d'utilisation.
PCT/IL2023/051245 2022-12-06 2023-12-05 Dispositif, système et méthode de fixation d'os fracturés WO2024121848A1 (fr)

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US202263430403P 2022-12-06 2022-12-06
US63/430,403 2022-12-06

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4465065A (en) * 1983-01-07 1984-08-14 Yechiel Gotfried Surgical device for connection of fractured bones
US5429641A (en) * 1993-03-28 1995-07-04 Gotfried; Yechiel Surgical device for connection of fractured bones
WO2009013568A1 (fr) * 2007-07-20 2009-01-29 Nilli Del Medico Dispositif chirurgical pour la connexion d'os fracturés
US20190290298A1 (en) * 2014-09-12 2019-09-26 Innovision, Inc. Bone drill guides and methods of use thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4465065A (en) * 1983-01-07 1984-08-14 Yechiel Gotfried Surgical device for connection of fractured bones
US5429641A (en) * 1993-03-28 1995-07-04 Gotfried; Yechiel Surgical device for connection of fractured bones
WO2009013568A1 (fr) * 2007-07-20 2009-01-29 Nilli Del Medico Dispositif chirurgical pour la connexion d'os fracturés
US20190290298A1 (en) * 2014-09-12 2019-09-26 Innovision, Inc. Bone drill guides and methods of use thereof

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