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WO2025203019A1 - Appareil et procédés de détection de changement de condition osseuse pour prédire des fractures fémorales périprothétiques peropératoires pendant une arthroplastie totale de la hanche - Google Patents

Appareil et procédés de détection de changement de condition osseuse pour prédire des fractures fémorales périprothétiques peropératoires pendant une arthroplastie totale de la hanche

Info

Publication number
WO2025203019A1
WO2025203019A1 PCT/IL2025/050224 IL2025050224W WO2025203019A1 WO 2025203019 A1 WO2025203019 A1 WO 2025203019A1 IL 2025050224 W IL2025050224 W IL 2025050224W WO 2025203019 A1 WO2025203019 A1 WO 2025203019A1
Authority
WO
WIPO (PCT)
Prior art keywords
femur
output
sensor
sensors
processing unit
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/IL2025/050224
Other languages
English (en)
Inventor
Nir Karasikov
James Randolph DICK
Nadav Cohen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Value Forces Ltd
Original Assignee
Value Forces Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Value Forces Ltd filed Critical Value Forces Ltd
Publication of WO2025203019A1 publication Critical patent/WO2025203019A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/92—Impactors or extractors, e.g. for removing intramedullary devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/164—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans intramedullary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1659—Surgical rasps, files, planes, or scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1664—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the hip
    • A61B17/1668—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the hip for the upper femur
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots

Definitions

  • the present invention is in the field of prevention of intraoperative periprosthetic femoral fractures during total hip arthroplasty (THA) surgery.
  • a Total Hip Replacement offers excellent results in patients of all ages.
  • a surgeon implants a femoral stem into the femur. It is very important to be able to estimate the broach/stem position, penetration progress, and the stress condition of the femur during the procedure.
  • US 2022/354594 refers to an Al system to teach good, medium, and bad broach insertion, based on qualitative observations, and reported outcomes.
  • the present invention relates to an apparatus and methods for the sensing of bone condition changes in real-time during broach and stem insertion into the femur during total hip arthroplasty (THA) to indicate the risk level for intraoperative periprosthetic femoral fracture.
  • THA total hip arthroplasty
  • One of the required sensors is a position sensor to measure the broach and stem insertion into the femur. Another sensor senses the impact force. Other sensors are an acoustic emission sensor; a spectral response sensor; and a sensor measuring torsional stiffness/freedom of the inserted implant, replicating a manual procedure performed by the surgeon during total hip arthroplasty (THA).
  • the method includes a real time Finite Element Analysis (FEA) boundary condition analysis and frequency response modeling of the femur, broach, and auto-impactor as a whole. This modeling is based on diagnostic images of the proximal femur geometry from a hospital’s pre-operative planning system, the implant geometry, and the implant insertion level determined by the position sensor.
  • FEA Finite Element Analysis
  • FIG. 1 is a side view of a real-time bone condition change monitoring apparatus, in accordance with the presently disclosed subject matter.
  • FIG. 3 is another side view of a portion of the apparatus, in accordance with the presently disclosed subject matter.
  • Figs. 4A-4C are graphs of a quasi-static load-displacement curve of a broach of the apparatus inserted into the femur, after removing the head of the femur (osteotomy), in accordance with the presently disclosed subject matter.
  • Fig. 5 is a graph of frequency response after impacts into a sheep bone, in accordance with the presently disclosed subject matter.
  • Fig. 7A is a graph showing impact force versus penetration, in accordance with the presently disclosed subject matter.
  • Fig. 7B is a graph showing the broach-bone frequency response and the stabilization of the responses at the proper insertion position, in accordance with the presently disclosed subject matter.
  • Fig. 8 is an algorithmic flow chart of an example of a methodology of the insertion, in accordance with the presently disclosed subject matter.
  • FIG. 9A and 9B show additional examples of the apparatus, in accordance with the presently disclosed subject matter.
  • the present subject matter relates to examples of an apparatus and methods for determining broach/stem propagation in the femur during each impact on the broach interface by the auto-impactor, while monitoring femur stress level and the generation of microcracks during the broach/stem insertion. For each example, a sensing solution is presented.
  • Fig. 1 relates to one example of an apparatus to monitor broach insertion into a femur 10.
  • the apparatus is used in conjunction with a broach 20 or stem for femoral insertion, an interface adapter 30, an auto-impactor 40; and two sensors, an accelerometer sensor 71 on the interface adapter of the autoimpactor, and a distal femur accelerometer sensor 72 attached on the leg/knee area.
  • Double signal integration and subtraction of the two accelerometers yields the amount of insertion and compensates for any movement of the patient.
  • Vibrational and velocity information are also available from the accelerometer sensors 71 , 72, via their original acceleration signals and their single integration and double integration (the velocity and propagation respectively).
  • the interface adapter 30 accelerometer sensor 71 can suffice.
  • Interface adapter accelerometer sensor 71 is attached directly to the auto-impactor interface adapter 30 between the broach or stem 20 and the auto-impactor 40. Alternatively it can be within the internal impacting part (moving mass) of the auto-impactor 40. There are other methods to measure position, by other types of position sensors - resistive, capacitive, optical and more as known in the art. They are all applicable to measure the insertion of the broach 20 into the femur 10 in the invention.
  • Fig. 3 shows an example of the apparatus where the auto-impactor 40 includes a torsional torque generating actuator 80 that automatically generates a minute torsional torque.
  • the actuator is a torque actuator 80 inside the autoimpactor 40 producing a rotational movement after impacts, symmetrical around the impact axis.
  • actuator 80 While actuator 80 is activated, the torsional stiffness or freedom assessment is detected via one of several types of angle sensors 81 , as known in the art, for example a magnetic Hall effect sensor.
  • the apparatus uses acoustic transducer/sensor 73 to detect frequency response and/or to generate a controlled excitation sweep.
  • the acoustic transducer/sensor 73 can be of many types to generate vibration in audible and ultrasonic (US) frequencies. Most common are piezo-ceramic disks but also a polymer acoustic transducer is applicable, such as a PVDF polymer transducer.
  • Piezo transducers are usually thin PZT discs. They are brittle and can break from the impacts, especially if the piezo disc is large.
  • One example uses an electret polymer with piezo properties, such as Polyvinylidene Fluoride (PVDF).
  • PVDF Polyvinylidene Fluoride
  • the benefits are no risk of breakage and a large sensor area in which it is possible to optimize dimensions (increase) for better matching to a lower frequency range.
  • the maximal response to surface waves will be when the dimension of the sensor is equivalent to half of the wavelength.
  • PVDF is flexible and can be extended in dimensions, without the PVDF breaking, to increase sensitivity and matching to the surface waves frequencies.
  • Method A generates a P-Delta load-displacement curve using signals from the insertion position sensor, implemented by an accelerometer as known in the art, 71 (or 71 and 72) or other insertion (position) sensors, and the impact force sensor 41 , and then monitoring the slopes of the P-Delta load-displacement curves throughout the broach and stem insertion process.
  • Provision # 6 - the two AE sensors 51 , 52 are used, as shown in Fig. 9B, symmetrical with respect to the propagation time from the impact surface 32 but not symmetrical in distance to the bone.
  • a differential signal of the two AE sensors 51 , 52 will mostly cancel the impact signal as it appears simultaneously on both sensors due to the equal distances from the impaction surface 32 in Fig. 9B, and will leave only the microcrack’s emission signal from the bone.
  • AE sensors 51 , 52 The position of AE sensors 51 , 52 with respect to the impact surface is shown in Fig. 9B.
  • the microcrack signals are not symmetrical to the acoustic emission sensors 51 , 52 in respect to propagation time while the impact is symmetrical.
  • the invention algorithms for sensing and analyzing can be integrated within the robotic operating platforms and application software of a robotic platform (not shown) and a robotic arm (not shown).
  • Hardware for the auto-impactor 40 can be integrated as part of a robotic platform and robot arm (not shown).

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil et des procédés pour empêcher une fracture fémorale périprothétique peropératoire dans une arthroplastie totale de la hanche (THA), par détermination des changements de position d'implant et d'os fémoral pendant la THA par détection de changements en temps réel. L'appareil fonctionne avec une broche ou une tige, qui est insérée dans le fémur ; un auto-impacteur ; et une diversité de capteurs sur l'adaptateur d'interface entre l'auto-impacteur et la broche/tige. L'appareil et les procédés indiquent la qualité d'insertion d'implant et permettent une détection et un avertissement précoces d'approche de la propension au point de fracture fémorale périprothétique peropératoire en utilisant des données de capteur quantifiables et des tendances et en fournissant des informations en temps réel dans un algorithme d'aide à la décision.
PCT/IL2025/050224 2024-03-28 2025-03-09 Appareil et procédés de détection de changement de condition osseuse pour prédire des fractures fémorales périprothétiques peropératoires pendant une arthroplastie totale de la hanche Pending WO2025203019A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL311825 2024-03-28
IL311825A IL311825A (en) 2024-03-28 2024-03-28 Device and methods for detecting bone status change to predict intraoperative periprosthetic hip fractures during total hip arthroplasty

Publications (1)

Publication Number Publication Date
WO2025203019A1 true WO2025203019A1 (fr) 2025-10-02

Family

ID=97216380

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2025/050224 Pending WO2025203019A1 (fr) 2024-03-28 2025-03-09 Appareil et procédés de détection de changement de condition osseuse pour prédire des fractures fémorales périprothétiques peropératoires pendant une arthroplastie totale de la hanche

Country Status (2)

Country Link
IL (1) IL311825A (fr)
WO (1) WO2025203019A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024023817A1 (fr) * 2022-07-25 2024-02-01 Value Forces Ltd. Appareil et procédés pour procédures orthopédiques telles que remplacement total de la hanche et insertion de la broche et de la tige

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024023817A1 (fr) * 2022-07-25 2024-02-01 Value Forces Ltd. Appareil et procédés pour procédures orthopédiques telles que remplacement total de la hanche et insertion de la broche et de la tige

Also Published As

Publication number Publication date
IL311825A (en) 2025-10-01

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