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WO2025117859A1 - Vis à os pour applications dentaires - Google Patents

Vis à os pour applications dentaires Download PDF

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Publication number
WO2025117859A1
WO2025117859A1 PCT/US2024/057906 US2024057906W WO2025117859A1 WO 2025117859 A1 WO2025117859 A1 WO 2025117859A1 US 2024057906 W US2024057906 W US 2024057906W WO 2025117859 A1 WO2025117859 A1 WO 2025117859A1
Authority
WO
WIPO (PCT)
Prior art keywords
screw
bone
drive
under
dental
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/US2024/057906
Other languages
English (en)
Inventor
Eswar KANDASWAMY
Peter DUPREE
James Dupree
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.)
Louisiana State University
Original Assignee
Louisiana State University
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 Louisiana State University filed Critical Louisiana State University
Publication of WO2025117859A1 publication Critical patent/WO2025117859A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • 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
    • A61B17/8866—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices for gripping or pushing bones, e.g. approximators
    • 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
    • A61B17/8872—Instruments for putting said fixation devices against or away from the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0009—Consolidating prostheses or implants, e.g. by means of stabilising pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive

Definitions

  • Embodiments are described herein involving the development and clinical testing of a novel screw or fixation device that are made of fully resorbable material for dental bone surgery procedures related to dental implants.
  • Figure 1 shows a tack, under an embodiment.
  • Figure 3 show a screw, under an embodiment.
  • Figure 4 shows a mounted tack, under an embodiment.
  • Figure 5 shows a cross-sectional view of a tack (with dimensions in millimeters), under an embodiment.
  • Figure 6 shows a tack (with dimensions in millimeters), under an embodiment.
  • Figure 7 shows a cross-sectional view of a tack, under an embodiment.
  • Figure 8 shows a mounted tack, under an embodiment.
  • Figure 9A and 9B shows a bone screw that can be used in maxillofacial surgery or orthopedics, under an embodiment.
  • Figure 10 shows a titanium screw, under an embodiment.
  • Figure 11 shows a titanium screw, under an embodiment.
  • Figure 12 shows a titanium screw, under an embodiment.
  • Figure 13 shows a titanium screw, under an embodiment.
  • Figure 14 shows delivery device for placing a dental screw in bone, under an embodiment.
  • Figure 15 shows delivery device (with exterior finish) for placing a dental screw in bone, under an embodiment.
  • Figure 16 shows a perspective view (with exterior finish) of a delivery device handle portion, under an embodiment.
  • Figure 17 shows a perspective view (with exterior finish) of a delivery device handle portion, under an embodiment.
  • Figure 18 shows a perspective view (with exterior finish) of a delivery device claw, under an embodiment.
  • Figure 19 shows a a perspective view (with exterior finish) of a delivery device claw, under an embodiment.
  • Figure 20 shows delivery device, under an embodiment.
  • Figure 21 shows a perspective view of a delivery device handle portion, under an embodiment.
  • Figure 22 shows a perspective view of a delivery device handle portion, under an embodiment.
  • Figure 23 shows a perspective view of a delivery device claw, under an embodiment.
  • Figure 24 shows a perspective view of a delivery device claw, under an embodiment.
  • Bone screws are used in orthopedic procedures and dental surgeries to hold bone fragments, fractures, and bone grafts before or during dental implant installation in the proper location during healing. These screws are either left in the body (mostly in orthopedic applications) or removed after fixation. Bone screws are manufactured in various sizes, shapes, and designs to accommodate the increasing demand for dental reconstructive procedures (1, 2). By the type of material, the global market for bone screws is segmented into stainless steel, titanium, and bioabsorbable. Titanium is the most commonly used material and is forecast to continue to dominate the market for the next 5 to 7 years. Its excellent corrosion resistance properties, as well as its high strength-to- weight ratio have driven demand (2, 3, 4).
  • bioabsorbable screws The segment of the market for bioabsorbable screws is forecast to experience robust growth during the next 5 to 7 years.
  • Polyglycolic acid, poly-L-lactic acid, and polylactic acid are the most commonly used bioabsorbable materials.
  • the benefits of bioabsorbable materials include less interference with MRI scans, decreased graft laceration, and reduced need for implant removal; all of these features drive the demand for products made with these materials (2, 3, 5, 6).
  • the development of innovative techniques and technical advancements create new opportunities in the global market for bone screws.
  • bio-composite materials and more affordable bone screw systems are of intense interest. Market trends forecast that an increasing number of plates, screws, pins, interface screws, and possibly joint replacements, will be made with bio-composite materials that will not be removed from the body after healing. This adds structure and stability to the repaired areas.
  • options for a tack/screw for dental bone regeneration applications are made out of titanium, stainless, or Polyglycolic acid, poly-L-lactic acid, and polylactic acid and magnesium screws. Of the options only Polyglycolic acid, poly-L-lactic acid, and polylactic acid and magnesium screws are resorbable but due to the nature of the material, they have the potential to cause significant tissue reaction.
  • the novel screw or fixation device (called bone screw) is made of xenograft, allograft, or alloplastic bone replacement grafts.
  • the creation of a screw out of the same bone materials (xenograft, allograft, or alloplast) similar to what is currently used for bone augmentation procedures eliminates the need for an additional retrieval step.
  • the bone replacement material can be made in the form of a screw or in the shape of a pyramid with a sharp end that allows for piercing and fixation of the membrane or be used as a tenting screw.
  • the screw can be self tapping or the host bone is prepared using a drill that creates a channel that is the same shape as the bone screw” and it can then be tapped or screwed into place.
  • Milling machines may mill a screw shaped device out of the currently available bone replacement materials. The milling is performed with a design and out of target materials that can withstand the torque and force generated during installation of the screws in human bone.
  • the screws are created from materials including allograft cortical bone blocks, xenograft cortical bone blocks, and hydroxyapatite or resorbable ceramic blocks. These blocks are milled to the shape of a screw (or pyramid shape or others, as discussed above). Alternative embodiments cast these materials into differing desired shapes.
  • a drill tap creates a channel in the bone to accept the bone screw.
  • a kit may comprise a drill/tap and screw (and also, a holder for the delivery of the screw into the bone and a mallet for tapping the screw in place (if needed)).
  • strength and performance of the screws are tested relative to the performance of available titanium screws, the gold standard.
  • testing is performed on saw-dust mandibles compared to currently available gold standard tacks and screws made out of titanium. The saw dust mandibles are commonly used for simulation exercises for dental implants and bone grafting in the dental field as they closely mimic the structure of real human bone. Once we evaluate the performance of our invention in this model, further testing is performed on cadavers or pig jaws to measure the time taken as well as the tapping ability of the prototype screw on the jaw bone.
  • in-vitro testing on hydroxyapatite cylinders is performed to determine if strength parameters are sufficient for screw/tack milling.
  • 3D drawings of a tack and screw for milling/ 3D printing applications are generated. For testing purposes, one may manually mill and machine the tack out of hydroxyapatite blocks.
  • Test results in the table directly above correspond to test preformed on HA and Titanium raw material discs. Under an embodiment, tack compressive stress without bone is tested. This test just compresses the screw until breakage or until the screw deforms or the test is stopped. It has two plates, and one plate pushes the screw towards the other and measures the forces. Such test was performed on twelve HA and twelve titanium screws. Results are set forth in table below. HA COMPRESSIVE
  • a resorbable tack made of allograft or alloplastic material is generated for dental applications.
  • pre-made hydroxyapatite blocks and cylinders are procured.
  • Strength testing is performed on the pre-made hydroxyapatite cylinders as a starting point for manual machining. Strength testing parameters were comparable to previously published literature on similar materials.
  • the tacks are manually machined for testing purposes.
  • the manually machined tacks are tested for strength parameters on dental bone models, bovine rib bone and human fresh cadaver mandibular samples with titanium tacks which are considered the gold standard. The results of the test are set forth above. To summarize the results, the manually milled hydroxyapatite tacks performed similarly in all three tests (force, compressive strength parameters) to the gold standard titanium tacks.
  • Maximum load is the maximum force that the screw withstands during the test (this depending on the screw type and can either be in the middle or end of the test in case of screw deformation or breakage).
  • the maximum compressive strength is the same parameter but it measures it in Mega pascal relative to the area of the screw. These parameters are important as the screw needs to be able to withstand the force without breakage or deformation when being driven into the bone. This is especially relevant if the screw is used without prior tapping (which in some cases is possible when the bone density is not too hard). All these strength tests were conducted without a drill tap prior to the screw test. Tf a drill tap is used, it is anticipated that the force required to drive the screw is a lot less.
  • Figure 1 shows an unmounted tack, under an embodiment.
  • Figure 2 shows an unmounted tack, under an embodiment.
  • Figure 3 show a screw, under an embodiment.
  • Figure 4 shows a mounted tack, under an embodiment.
  • Figure 5 shows a cross-sectional view of a tack (with dimensions in millimeters), under an embodiment.
  • Figure 6 shows a tack (with dimensions in millimeters), under an embodiment.
  • Figure 7 shows a cross-sectional view of a tack, under an embodiment.
  • Figure 8 shows a mounted tack, under an embodiment.
  • the milled (or 3D printed) tacks are approximately (with a 0.5mm dimensional tolerance) 3mm diameter at the head, 1 mm diameter of the body and 2-3 mm in length of the tack portion. These dimensions are roughly based on pre-existing screws made out of titanium.
  • Figure 9A and 9B show a bone screw that can be used in maxillofacial surgery or orthopedics, under an embodiment.
  • Figure 10 shows a titanium screw, under an embodiment.
  • Figure 11 shows a titanium screw, under an embodiment.
  • Figure 12 shows a titanium screw, under an embodiment.
  • Figure 13 shows a titanium screw, under an embodiment.
  • Figure 14 shows device 1400 for placing a dental screw in bone, under an embodiment.
  • the device includes a handle portion 1410 comprising a proximal grip 1412 and trigger component 1414.
  • the trigger component is rotatably coupled to a securing pin 1416 laterally disposed through a body 1418 of the device 1400.
  • An upper end of the trigger component 1414 (housed within the body 1418) is attached to a drive component 1420 which threadably engages a drive screw 1422.
  • the drive screw is attached to a connecting rod (not shown) which extends through a barrel portion 1430 and is itself attached to or integrally formed with a claw 1440.
  • the drive component moves in a distal direction.
  • the drive screw is configured such that distal movement of the drive component retracts the drive screw which then retracts the connecting rod and claw. (The drive screw may be configured to provide motion in the opposite direction).
  • the claw features a point of attachment 1442 for securing a bone screw in place. Bone is placed between an attached bone screw and an oppositely disposed base 1444. Retraction of the claw as described above generates force to insert the screw into bone.
  • Figure 15 shows delivery device (with exterior finish) for placing a dental screw in bone, under an embodiment.
  • Figure 16 shows a perspective view (with exterior finish) of a delivery device handle portion, under an embodiment.
  • Figure 17 shows a perspective view (with exterior finish) of a delivery device handle portion, under an embodiment.
  • Figure 18 shows a perspective view (with exterior finish) of a delivery device claw, under an embodiment.
  • Figure 19 shows a a perspective view (with exterior finish) of a delivery device claw, under an embodiment.
  • Figure 20 shows delivery device, under an embodiment.
  • Figure 21 shows a perspective view of a delivery device handle portion, under an embodiment.
  • Figure 22 shows a perspective view of a delivery device handle portion, under an embodiment.
  • Figure 23 shows a perspective view of a delivery device claw, under an embodiment.
  • Figure 24 shows a perspective view of a delivery device claw, under an embodiment.
  • Bone Screw System Market Industry Analysis and Forecast (2021-2027) by Type and Application, Maximize Market Research, 2021.
  • Bone Screw System Market Overview Industry ARC, 2022.

Landscapes

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

Abstract

L'invention concerne un dispositif comprenant une vis dentaire conçue pour être insérée dans un os, la vis dentaire comprenant un matériau bioabsorbable, la vis dentaire comprenant une tête annulaire et un corps, le corps se terminant au niveau d'un point distal pointu conçu pour percer l'os, et le matériau bioabsorbable comprenant un matériau alloplastique.
PCT/US2024/057906 2023-11-28 2024-11-27 Vis à os pour applications dentaires Pending WO2025117859A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363603482P 2023-11-28 2023-11-28
US63/603,482 2023-11-28

Publications (1)

Publication Number Publication Date
WO2025117859A1 true WO2025117859A1 (fr) 2025-06-05

Family

ID=95898076

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/057906 Pending WO2025117859A1 (fr) 2023-11-28 2024-11-27 Vis à os pour applications dentaires

Country Status (1)

Country Link
WO (1) WO2025117859A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6471707B1 (en) * 2001-05-11 2002-10-29 Biomet Bone screw having bioresorbable proximal shaft portion
US20170325914A1 (en) * 2014-10-23 2017-11-16 Universität Bremen Anchor implant
WO2022204774A1 (fr) * 2021-03-31 2022-10-06 M3 Health Indústria E Comércio De Produtos Médicos, Odontológicos E Correlatos S.A. Implant médical partiellement résorbable et procédé de fabrication d'un tel implant

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6471707B1 (en) * 2001-05-11 2002-10-29 Biomet Bone screw having bioresorbable proximal shaft portion
US20170325914A1 (en) * 2014-10-23 2017-11-16 Universität Bremen Anchor implant
WO2022204774A1 (fr) * 2021-03-31 2022-10-06 M3 Health Indústria E Comércio De Produtos Médicos, Odontológicos E Correlatos S.A. Implant médical partiellement résorbable et procédé de fabrication d'un tel implant

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