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WO2024063738A1 - A disc prosthesis comprising biological material - Google Patents

A disc prosthesis comprising biological material Download PDF

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Publication number
WO2024063738A1
WO2024063738A1 PCT/TR2023/050950 TR2023050950W WO2024063738A1 WO 2024063738 A1 WO2024063738 A1 WO 2024063738A1 TR 2023050950 W TR2023050950 W TR 2023050950W WO 2024063738 A1 WO2024063738 A1 WO 2024063738A1
Authority
WO
WIPO (PCT)
Prior art keywords
plate
disc prosthesis
resilient element
vertebrae
patient
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.)
Ceased
Application number
PCT/TR2023/050950
Other languages
French (fr)
Inventor
Teyfik DEMIR
Rabia CAKIR KOC
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.)
Tobb Ekonomi Ve Teknoloji Universitesi
Original Assignee
Tobb Ekonomi Ve Teknoloji Universitesi
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
Priority claimed from TR2022/014583 external-priority patent/TR2022014583A1/en
Application filed by Tobb Ekonomi Ve Teknoloji Universitesi filed Critical Tobb Ekonomi Ve Teknoloji Universitesi
Publication of WO2024063738A1 publication Critical patent/WO2024063738A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/06—Titanium or titanium alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30014—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30069—Properties of materials and coating materials elastomeric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • A61F2002/30843—Pyramidally-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30879—Ribs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
    • A61F2002/443—Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs

Definitions

  • the present invention relates to a disc prosthesis which is used in spinal surgery and placed between the vertebrae during the operation.
  • Herniated disc and cervical disc hernia result from displacement of the cartilage (disc) between the vertebrae towards the spinal canal, and thus applying pressure on the nerves and the spinal cord.
  • herniated disc and cervical disc hernia surgeries can be performed in smaller spaces than before.
  • a cage into which bone graft is added and which prevents collapse between the vertebrae, is placed.
  • the cage structures used in the state of the art are typically sized by taking the distance between the vertebrae of the patient as an average.
  • the said cages are rigid and do not support the relative angular or rotational movement of the vertebrae.
  • the said prosthesis comprises first and second plates to be fixed to the adjacent cervical vertebrae and a swivel joint between the said two plates that are mounted one above the other;
  • the said joint consists of a spherical cap cooperating with a spherical cup, wherein the spherical cap is arranged on a first insert and the spherical cup is arranged on a second insert;
  • the inserts are made of ceramic material and have a round base with a flat crosssection; one of the inserts is mounted on the first plate, while the other is mounted on the second plate such that the center of rotation of the joint is mounted substantially centered with respect to the edges of the plates, so that the vertebrae are centered both in the frontal plane and in the vertical plane.
  • Turkish patent document TR201202625 an application in the state of the art, discloses an intervertebral disc endoprosthesis for completely replacing the intervertebral disc in the lumbar and cervical spine region, comprising articulating sliding partners, wherein the upper sliding partner comprises means for establishing a firm connection with the upper vertebral body and the lower sliding partner comprises means for establishing a firm connection with the lower vertebral body, and at least one sliding surface is provided between the sliding partners.
  • Functional two-part and three-part prosthesis models are provided in the invention, and for both prostheses only one dorsoventral and rotating motion is possible due to the latero-laterally oriented cylindrical convexities, which are curved in a transversally arched manner toward the ventral region, and to the corresponding concavities, however no inclination of the sliding partners can occur in the lateral direction.
  • the cylindrical articulation surfaces are not curved, whereby the sliding partners are only able to move in the ventrodorsal direction.
  • the inventive intervertebral disc endoprostheses are suited for being implanted laterally and ventrolaterally, in particular, during revision operations.
  • two-part mobile disc prostheses allow angulation and rotation but not axial movement.
  • Tissue grows between the upper and lower plates (endplates) provided in the said mobile disc prostheses and causes the disc prosthesis to be locked. In this case, fusion occurs in the disc prosthesis.
  • Another object of the present invention is to provide a disc prosthesis adapted to facilitate angular movement between the vertebrae.
  • a further object of the present invention is to provide a disc prosthesis adapted to facilitate rotational movement between vertebrae.
  • Another object of the present invention is to provide a disc prosthesis adapted to facilitate axial movement between the vertebrae.
  • Yet another object of the present invention is to provide a disc prosthesis that prevents formation of fusion between the vertebrae.
  • a disc prosthesis which is developed to achieve the objects of the present invention and is defined in the first claim and the other claims dependent thereon, comprises a first plate, a second plate and a resilient element.
  • the first plate and the second plate are rigid plates which contact the vertebrae and are used for maintaining the distance between the vertebrae, and a resilient element is provided between the said first plate and the said second plate.
  • the said resilient element is positioned between the first plate and the second plate to support the axial, angular and rotational movement of the vertebrae.
  • Figure 1 is a perspective view of the disc prosthesis.
  • Figure 2 is a cross-sectional view of the disc prosthesis.
  • a disc prosthesis (1) which is used in spinal surgery, is placed between the vertebrae, and enables to support the relative movement between the vertebrae axially, as well as angularly and rotationally, basically comprises at least one first plate (2) which is adapted to contact one of the two vertebrae and to support the said vertebra, at least one first plate (2) which is adapted to contact the other vertebra that the first plate (2) does not contact and to support the said other vertebra, at least one resilient element (4), which is positioned between the first plate (2) and the second plate (3) such that it can move in more than one degree of freedom depending on the compressive, tensile, bending or rotational forces resulting in different directions between the two vertebrae,
  • • is a biological tissue that is produced by decellularization method in order to enable axial, as well as angular and rotational movements
  • the disc prosthesis (1) in one embodiment of the invention comprises at least one first plate (2).
  • the said first plate (2) preferably has a cylindrical or elliptical geometrical form and is produced from poly etheretherketone (PEEK), titanium or a biocompatible material.
  • PEEK poly etheretherketone
  • the first plate (2) can also be produced in a geometrical form that allows to enter between the vertebrae and provide maximum contact with the vertebral surface.
  • the said first plate (2) forms the part of the disc prosthesis (1) that contacts and supports one of the vertebrae, and the first plate (2) has a plurality of first ribs (2.1) on the side thereof that contacts the vertebra.
  • the said first ribs (2.1) provided in the first plate (2) are inserted into the vertebrae, ensuring a sturdier attachment, and maintaining the position of the first plate (2).
  • the wall thickness of the first plate (2) is calculated according to the forces resulting between the vertebrae in different directions as a result of the patient's movement and it is produced at a thickness that can resist these forces.
  • the disc prosthesis (1) in the said embodiment of the invention comprises at least one second plate (3).
  • the said second plate (3) is similar to the first plate (2) and is adapted to support the other vertebra that is not supported by the first plate (2).
  • the second plate (3) also preferably has a cylindrical or elliptical geometrical form and is produced from poly etheretherketone (PEEK), titanium or a biocompatible material.
  • PEEK poly etheretherketone
  • the form of the second plate (3) can be produced in a geometrical form that allows to enter between the vertebrae and provide maximum contact with the vertebral surface.
  • the second plate (3) forms the part of the disc prosthesis (1) that contacts and supports one of the vertebrae, and there is a plurality of second ribs (3.1) provided on the side of the second plate (3) that contacts the vertebra.
  • the said second ribs (3.1) provided on the second plate (3) similar to the first ribs (2.1) in the first plate (2), are inserted into the vertebrae, ensuring a sturdier attachment, and maintaining the position of the second plate (3).
  • the wall thicknesses and materials of the second plate (3) and the first plate (2) are similar so that they have the same strength and resistance.
  • At least one resilient element (4) is inserted between the first plate (2) and the second plate (3) in order to ensure that the load applied to the first plate (2) and the second plate (3) by the vertebrae of the patient is compensated without the first plate (2) and the second plate (3) coming into contact with each other.
  • the said resilient element (4) creates a distance between the first plate (2) and the second plate (3), enabling a clearance (4.1) to be formed there.
  • the resilient element (4) provided in this embodiment of the invention has almost the same size as the circumference of the first plate (2) and the second plate (3) and has such dimensions that it forms a height between the first plate (2) and the second plate (3) so that the first plate (2) and the second plate (3) do not come into contact with each other.
  • a clearance (4.1) is formed between the first plate (2), the second plate (3) and the resilient element (4), and a resilient material or hydrogel can be injected into or withdrawn from the said clearance (4.1) through an opening (5) provided in the first plate (2) or the second plate (3) or the resilient element (4).
  • the said resilient material or hydrogel is a material whose rigidity can be changed according to the physical characteristics of the patient and is calculated to be of different rigidity levels according to different patient groups (height, age, weight) and is placed or injected into the clearance (4.1) before the disc prosthesis (1) is inserted between the patient's vertebrae, and prevents the first plate (2) and the second plate (3) from contacting each other and also prevents them from acting rigidly according to the force applied by the vertebrae during the patient’ s movement. For example, when the patient is in an upright position, the distance between the first plate (2) and the second plate (3) is the same on all sides.
  • the resilient element (4) can also move rotationally in a similar way, allowing the first plate (2) and the second plate (3) to make relative rotational movements relative to each other.
  • the resilient element (4) provided in this embodiment of the invention is a biological tissue, wherein the said biological tissue is produced by the method of decellularization, in which only the cells are removed, and the scaffold is preserved maintaining the unique architecture of the biological tissue.
  • the resilient element (4) provided in this embodiment of the invention is preferably an aorta.
  • the resilient element (4) in this embodiment of the invention is attached to the first plate (2) and the second plate (3) in a sealed manner via suturing. The suturing is performed with a biocompatible suture thread.
  • the resilient element (4) provided in another embodiment of the invention is closed such that a clearance (4.1) is formed in its interior, and the first plate (2) and the second plate (3) are placed on opposite sides thereof, and the disc prosthesis (1) is formed in this way.
  • the other surfaces of the first plate (2) and the second plate (3), which are not in contact with the vertebrae, are in contact with the resilient element (4).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Vascular Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Inorganic Chemistry (AREA)
  • Prostheses (AREA)

Abstract

The present invention relates to a disc prosthesis (1) which is used in spinal surgery and placed between the vertebrae during the operation.

Description

A DISC PROSTHESIS COMPRISING BIOLOGICAL MATERIAL
Field of the Invention
The present invention relates to a disc prosthesis which is used in spinal surgery and placed between the vertebrae during the operation.
Background of the Invention
Herniated disc and cervical disc hernia result from displacement of the cartilage (disc) between the vertebrae towards the spinal canal, and thus applying pressure on the nerves and the spinal cord.
As a result of herniation, acute pain and loss of sense may occur in the area of the hernia. In some patients, such pain and loss of sense can only be eliminated by surgical intervention. In parallel with the advances in technology, herniated disc and cervical disc hernia surgeries can be performed in smaller spaces than before. In operations for herniated discs and cervical disc hernia, the region between two vertebrae is emptied and the disc between said vertebrae is removed, and subsequent to cleaning the region, a cage, into which bone graft is added and which prevents collapse between the vertebrae, is placed. The cage structures used in the state of the art are typically sized by taking the distance between the vertebrae of the patient as an average. In addition, the said cages are rigid and do not support the relative angular or rotational movement of the vertebrae.
The most important problem in relation to the cage structures currently used in surgical applications is that although the lengths of the cages are adjusted according to the height of the patient, the cages are in a rigid form and therefore make the movements of the vertebrae relative to each other difficult. Turkish patent document TR200500844, an application in the state of the art, discloses a disc prosthesis for cervical vertebrae. The said prosthesis comprises first and second plates to be fixed to the adjacent cervical vertebrae and a swivel joint between the said two plates that are mounted one above the other; the said joint consists of a spherical cap cooperating with a spherical cup, wherein the spherical cap is arranged on a first insert and the spherical cup is arranged on a second insert; the inserts are made of ceramic material and have a round base with a flat crosssection; one of the inserts is mounted on the first plate, while the other is mounted on the second plate such that the center of rotation of the joint is mounted substantially centered with respect to the edges of the plates, so that the vertebrae are centered both in the frontal plane and in the vertical plane.
Turkish patent document TR201202625, an application in the state of the art, discloses an intervertebral disc endoprosthesis for completely replacing the intervertebral disc in the lumbar and cervical spine region, comprising articulating sliding partners, wherein the upper sliding partner comprises means for establishing a firm connection with the upper vertebral body and the lower sliding partner comprises means for establishing a firm connection with the lower vertebral body, and at least one sliding surface is provided between the sliding partners. Functional two-part and three-part prosthesis models are provided in the invention, and for both prostheses only one dorsoventral and rotating motion is possible due to the latero-laterally oriented cylindrical convexities, which are curved in a transversally arched manner toward the ventral region, and to the corresponding concavities, however no inclination of the sliding partners can occur in the lateral direction. In another embodiment, the cylindrical articulation surfaces are not curved, whereby the sliding partners are only able to move in the ventrodorsal direction. The inventive intervertebral disc endoprostheses are suited for being implanted laterally and ventrolaterally, in particular, during revision operations. In the state of the art, two-part mobile disc prostheses allow angulation and rotation but not axial movement. Tissue grows between the upper and lower plates (endplates) provided in the said mobile disc prostheses and causes the disc prosthesis to be locked. In this case, fusion occurs in the disc prosthesis.
In the state of the art, there is no disc prosthesis that supports the movement between two vertebrae axially, as well as angularly and rotationally, and also prevents inward tissue growth with the help of a biological tissue.
Objects of the Invention
It is an object of the present invention to provide a disc prosthesis that creates a distance between the two vertebrae to which it is applied, allowing the patient to resume daily life in a short period of time.
Another object of the present invention is to provide a disc prosthesis adapted to facilitate angular movement between the vertebrae.
A further object of the present invention is to provide a disc prosthesis adapted to facilitate rotational movement between vertebrae.
Another object of the present invention is to provide a disc prosthesis adapted to facilitate axial movement between the vertebrae.
Yet another object of the present invention is to provide a disc prosthesis that prevents formation of fusion between the vertebrae.
Summary of the Invention
A disc prosthesis which is developed to achieve the objects of the present invention and is defined in the first claim and the other claims dependent thereon, comprises a first plate, a second plate and a resilient element. The first plate and the second plate are rigid plates which contact the vertebrae and are used for maintaining the distance between the vertebrae, and a resilient element is provided between the said first plate and the said second plate. The said resilient element is positioned between the first plate and the second plate to support the axial, angular and rotational movement of the vertebrae.
Detailed Description of the Invention
The disc prosthesis developed to achieve the objects of the present invention is illustrated in the accompanying figures in which
Figure 1 is a perspective view of the disc prosthesis.
Figure 2 is a cross-sectional view of the disc prosthesis.
The components in the figures are numbered individually and the reference numbers corresponding thereto are given below:
1. Disc prosthesis
2. First plate
2.1. First rib
3. Second plate
3.1. Second rib
4. Resilient element
4.1. Clearance
5. Opening
A disc prosthesis (1), which is used in spinal surgery, is placed between the vertebrae, and enables to support the relative movement between the vertebrae axially, as well as angularly and rotationally, basically comprises at least one first plate (2) which is adapted to contact one of the two vertebrae and to support the said vertebra, at least one first plate (2) which is adapted to contact the other vertebra that the first plate (2) does not contact and to support the said other vertebra, at least one resilient element (4), which is positioned between the first plate (2) and the second plate (3) such that it can move in more than one degree of freedom depending on the compressive, tensile, bending or rotational forces resulting in different directions between the two vertebrae,
• is adapted to form a clearance (4.1) between the first plate (2) and the second plate (3),
• is a biological tissue that is produced by decellularization method in order to enable axial, as well as angular and rotational movements,
• is designed such that a resilient material can be inserted into and removed out of the clearance (4.1).
The disc prosthesis (1) in one embodiment of the invention comprises at least one first plate (2). The said first plate (2) preferably has a cylindrical or elliptical geometrical form and is produced from poly etheretherketone (PEEK), titanium or a biocompatible material. When preferred, the first plate (2) can also be produced in a geometrical form that allows to enter between the vertebrae and provide maximum contact with the vertebral surface. The said first plate (2) forms the part of the disc prosthesis (1) that contacts and supports one of the vertebrae, and the first plate (2) has a plurality of first ribs (2.1) on the side thereof that contacts the vertebra. The said first ribs (2.1) provided in the first plate (2) are inserted into the vertebrae, ensuring a sturdier attachment, and maintaining the position of the first plate (2). The wall thickness of the first plate (2) is calculated according to the forces resulting between the vertebrae in different directions as a result of the patient's movement and it is produced at a thickness that can resist these forces.
The disc prosthesis (1) in the said embodiment of the invention comprises at least one second plate (3). The said second plate (3) is similar to the first plate (2) and is adapted to support the other vertebra that is not supported by the first plate (2). Similar to the first plate (2), the second plate (3) also preferably has a cylindrical or elliptical geometrical form and is produced from poly etheretherketone (PEEK), titanium or a biocompatible material. Similar to the first plate (2), when preferred, the form of the second plate (3) can be produced in a geometrical form that allows to enter between the vertebrae and provide maximum contact with the vertebral surface. The second plate (3) forms the part of the disc prosthesis (1) that contacts and supports one of the vertebrae, and there is a plurality of second ribs (3.1) provided on the side of the second plate (3) that contacts the vertebra. The said second ribs (3.1) provided on the second plate (3), similar to the first ribs (2.1) in the first plate (2), are inserted into the vertebrae, ensuring a sturdier attachment, and maintaining the position of the second plate (3). The wall thicknesses and materials of the second plate (3) and the first plate (2) are similar so that they have the same strength and resistance.
In the disc prosthesis (1) of the said embodiment of the present invention, at least one resilient element (4) is inserted between the first plate (2) and the second plate (3) in order to ensure that the load applied to the first plate (2) and the second plate (3) by the vertebrae of the patient is compensated without the first plate (2) and the second plate (3) coming into contact with each other. The said resilient element (4) creates a distance between the first plate (2) and the second plate (3), enabling a clearance (4.1) to be formed there. The resilient element (4) provided in this embodiment of the invention has almost the same size as the circumference of the first plate (2) and the second plate (3) and has such dimensions that it forms a height between the first plate (2) and the second plate (3) so that the first plate (2) and the second plate (3) do not come into contact with each other. In this way, a clearance (4.1) is formed between the first plate (2), the second plate (3) and the resilient element (4), and a resilient material or hydrogel can be injected into or withdrawn from the said clearance (4.1) through an opening (5) provided in the first plate (2) or the second plate (3) or the resilient element (4). The said resilient material or hydrogel is a material whose rigidity can be changed according to the physical characteristics of the patient and is calculated to be of different rigidity levels according to different patient groups (height, age, weight) and is placed or injected into the clearance (4.1) before the disc prosthesis (1) is inserted between the patient's vertebrae, and prevents the first plate (2) and the second plate (3) from contacting each other and also prevents them from acting rigidly according to the force applied by the vertebrae during the patient’ s movement. For example, when the patient is in an upright position, the distance between the first plate (2) and the second plate (3) is the same on all sides. However, when the patient leans forward, one side of the first plate (2) and of the second plate (3) are closer to each other than they were in the initial position, while the opposite sides of this part are farther apart from each other compared to the initial position. This allows the patient to move more easily. In addition, the vertebrae tend to make a similar rotational movement when the patient turns left, right, or back. In this case, the resilient element (4) can also move rotationally in a similar way, allowing the first plate (2) and the second plate (3) to make relative rotational movements relative to each other.
The resilient element (4) provided in this embodiment of the invention is a biological tissue, wherein the said biological tissue is produced by the method of decellularization, in which only the cells are removed, and the scaffold is preserved maintaining the unique architecture of the biological tissue. The resilient element (4) provided in this embodiment of the invention is preferably an aorta. The resilient element (4) in this embodiment of the invention is attached to the first plate (2) and the second plate (3) in a sealed manner via suturing. The suturing is performed with a biocompatible suture thread.
The resilient element (4) provided in another embodiment of the invention is closed such that a clearance (4.1) is formed in its interior, and the first plate (2) and the second plate (3) are placed on opposite sides thereof, and the disc prosthesis (1) is formed in this way. In this case, the other surfaces of the first plate (2) and the second plate (3), which are not in contact with the vertebrae, are in contact with the resilient element (4).

Claims

CLAIMS A disc prosthesis (1), which is used in spinal surgery, is placed between the vertebrae, and enables to support the relative movement between the vertebrae axially, as well as angularly and rotationally, basically comprising at least one first plate (2) which is adapted to contact one of the two vertebrae and to support the said vertebra, at least one first plate (2) which is adapted to contact the other vertebra that the first plate (2) does not contact and to support the said other vertebra, and characterized by at least one resilient element (4), which is positioned between the first plate (2) and the second plate (3) such that it can move in more than one degree of freedom depending on the compressive, tensile, bending or rotational forces resulting in different directions between the two vertebrae,
• is adapted to form a clearance (4.1) between the first plate (2) and the second plate (3),
• is a biological tissue that is produced by decellularization method in order to enable axial, as well as angular and rotational movements,
• is designed such that a resilient material can be inserted into and removed out of the clearance (4.1). A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which is inserted between the first plate (2) and the second plate (3) in order to ensure that the load applied to the first plate (2) and the second plate (3) by the vertebrae of the patient is compensated without the first plate (2) and the second plate (3) coming into contact with each other. A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which creates a distance between the first plate (2) and the second plate (3), enabling a clearance (4.1) to be formed there. A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which has almost the same size as the circumference of the first plate (2) and the second plate (3) and has such dimensions that it forms a height between the first plate (2) and the second plate (3) so that the first plate (2) and the second plate (3) do not come into contact with each other. A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) into or out of which can be inserted or removed a resilient material whose rigidity can be changed according to the physical characteristics of the patient and is calculated to be of different rigidity levels according to different patient groups (height, age, weight). A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) into or out of which can be injected or withdrawn a hydrogel whose rigidity can be changed according to the physical characteristics of the patient and is calculated to be of different rigidity levels according to different patient groups (height, age, weight). A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which houses a hydrogel or a resilient material that prevents the first plate (2) and the second plate (3) from contacting each other and also prevents them from acting rigidly according to the force applied by the vertebrae during the patient’s movement A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which is an aorta. A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which is attached to the first plate (2) and the second plate (3) in a sealed manner via suturing. A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which is closed such that a clearance (4.1) is formed in its interior, and the first plate (2) and the second plate (3) are placed on opposite sides thereof. A disc prosthesis (1) according to Claim 1, characterized by the resilient element (4) which is designed such that a hydrogel can be injected into and withdrawn from the clearance (4.1) thereof.
PCT/TR2023/050950 2022-09-22 2023-09-13 A disc prosthesis comprising biological material Ceased WO2024063738A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2022/014583 TR2022014583A1 (en) 2022-09-22 A DISC PROSTHESIS CONTAINING BIOLOGICAL MATERIAL
TR2022014583 2022-09-22

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020077701A1 (en) * 2000-12-15 2002-06-20 Kuslich Stephen D. Annulus-reinforcing band
WO2004016205A2 (en) * 2002-08-15 2004-02-26 Coppes Justin K Intervertebral disc implant
WO2017044570A1 (en) * 2015-09-08 2017-03-16 Clemson University Decellularized biomaterial and method for formation
US20180055622A1 (en) * 2016-08-24 2018-03-01 Arthrex, Inc. Tissue Use for Repair of Injury
CN209847470U (en) * 2018-11-30 2019-12-27 四川大学华西医院 Artificial cervical intervertebral disc bone gap filling device and artificial intervertebral disc prosthesis

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020077701A1 (en) * 2000-12-15 2002-06-20 Kuslich Stephen D. Annulus-reinforcing band
WO2004016205A2 (en) * 2002-08-15 2004-02-26 Coppes Justin K Intervertebral disc implant
WO2017044570A1 (en) * 2015-09-08 2017-03-16 Clemson University Decellularized biomaterial and method for formation
US20180055622A1 (en) * 2016-08-24 2018-03-01 Arthrex, Inc. Tissue Use for Repair of Injury
CN209847470U (en) * 2018-11-30 2019-12-27 四川大学华西医院 Artificial cervical intervertebral disc bone gap filling device and artificial intervertebral disc prosthesis

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