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WO2019134746A1 - Dispositif d'implant de cathéter pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence - Google Patents

Dispositif d'implant de cathéter pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence Download PDF

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Publication number
WO2019134746A1
WO2019134746A1 PCT/EP2018/050164 EP2018050164W WO2019134746A1 WO 2019134746 A1 WO2019134746 A1 WO 2019134746A1 EP 2018050164 W EP2018050164 W EP 2018050164W WO 2019134746 A1 WO2019134746 A1 WO 2019134746A1
Authority
WO
WIPO (PCT)
Prior art keywords
implantable device
occluder
balloon catheter
annulus fibrosus
nucleus pulposus
Prior art date
Application number
PCT/EP2018/050164
Other languages
English (en)
Inventor
Orkun KAYMAKCI
Celal Vatansever
Ersin Donmez
Husnu Kerpicci
Izzet YILDIZ
Kutay Edis
Mehmet Durmaz
Original Assignee
Arcelik Anonim Sirketi
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 Arcelik Anonim Sirketi filed Critical Arcelik Anonim Sirketi
Priority to PCT/EP2018/050164 priority Critical patent/WO2019134746A1/fr
Priority to TR2018/20233A priority patent/TR201820233A2/tr
Publication of WO2019134746A1 publication Critical patent/WO2019134746A1/fr

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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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00261—Discectomy
    • 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
    • A61F2002/4435—Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
    • 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
    • A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus

Definitions

  • the present invention relates to a woven catheter implant device for restoring a damaged or degenerated intervertebral disc.
  • annulus fibrosis structure of the intervertebral discs can be disrupted due to traumas, or as a result of chronic deterioration.
  • the disruption of the annulus fibrosis structure can lead to disc herniation, rupture of the annulus and/or prolapse of the nucleus pulposus.
  • the currently available treatments for disc problems include invasive surgical procedures such as discectomy, laminectomy, laminotomy and/or spine fusion procedures.
  • alternative methods such as injecting curable materials into the nucleus, disc prosthesis devices and nucleus pulposus augmentation devices are being investigated.
  • the implant should also be easily replaceable by non-invasive methods, in case any complications arise.
  • the implant should maintain its viscoelastic properties during its lifetime.
  • the implant should also be designed so that it will not be forced out of the annulus fibrosis, leading to symptoms relating to hernia.
  • US2005245938 discloses a device for repair of intervertebral discs and cartilages in articular joints comprising a catheter for inserting through a cannula, the catheter having a distal end and a proximal end and a lumen extending longitudinally therethrough.
  • An expandable balloon may optionally be detachably attached to the catheter near the distal end.
  • the proximal end of the catheter is coupled to an injector that holds a supply of a thermoplastic elastomer material at a predetermined elevated temperature sufficiently high to maintain the thermoplastic elastomer at a liquid state.
  • the device allows a thermoplastic elastomer material to be injected into the intervertebral disc space or the articular joint space as a replacement prosthetic for the disc's nucleus pulposus or the joint's cartilage.
  • Other prior art publications may be referred to as WO2005032434 and US2004091540.
  • the present invention provides a catheter device comprising a balloon catheter which can be inserted into the nucleus pulposus in uninflated state via a cannula and which has improved mechanical and elastic properties.
  • the present invention provides a balloon catheter device for restoring a damaged or degenerated intervertebral disc, as provided by the characterizing features defined in Claim 1.
  • Primary object of the present invention is to provide a woven balloon catheter device for restoring a damaged or degenerated intervertebral disc.
  • the present invention proposes an implantable device comprising a balloon catheter introduced into the nucleus pulposus in a first configuration to be expanded in a second configuration.
  • a disrupted region in the annulus fibrosus is closed by an inner occluder in response to retracting movement of the cannula.
  • a stent connects the inner occluder to an outer occluder and comprises notches and micro-channels to improve adhesion to biological tissue.
  • Fig. 1A demonstrates a perspective view of a catheter device in operational position according to the present invention.
  • Fig. 1B demonstrates a side view of a catheter device in operational position according to the present invention.
  • Fig. 2 demonstrates a sectional isometric view of a catheter device in operational position according to the present invention.
  • the present invention proposes an implantable device (1).
  • Said implantable device (1) comprises a balloon catheter (3), a stent (4), an inner occluder (5) and an outer occluder (6).
  • Said balloon catheter (3) has a woven structure comprising flexible polymeric fibers (7) having high tensile strength.
  • the fibers (7) are woven in a biaxial or crisscross fashion, forming a composite structure that is both flexible enough to support inflation and strong enough to carry heavy loads.
  • Said balloon catheter (3) can be inserted into the nucleus pulposus inside annulus fibrosus (2) via a cannula (not shown) in a minimally invasive manner.
  • Balloon catheter (3) is inflated inside the nucleus pulposus by pumping curable elastomeric material or medical grade silicone elastomers thereinto. The material is typically pumped into balloon catheter (3) via an injector.
  • the inflated balloon catheter (3) will increase the distance between the intervertebral discs due to its composite structure. Also the woven structure of balloon catheter (3) ensure that said balloon catheter (3) does not get deformed, ripped or otherwise damaged during the process of inflation.
  • occluder structures When balloon catheter (3) is successfully inserted, the hole in the annulus fibrosus (2) is plugged by occluder structures only activated in response to retracting movement of said cannula.
  • Said occluder structures preferably comprise an inner occluder (5) and an outer occluder (6).
  • Stent (4) structure between said inner occluder (5) and outer occluder (6) provide stabilization and adhesion to the tissue.
  • Said balloon catheter (3) may be filled by silicone elastomer or curable elastomer.
  • Said balloon catheter’s (3) woven structure imparts endurance while preserving flexibility.
  • the viscoelastic property of the balloon catheter also imparts shock absorbing capabilities.
  • the cannula through which the balloon catheter (3) is inserted into the nucleus pulposus contains stents (4) in connection with said balloon catheter (3), by which the system can be stabilized, and the balloon catheter (3) is prevented from being forced out of the annulus fibrosis.
  • the stent (4) also includes notches and micro-channels to improve adhesion to biological tissue.
  • the present invention proposes an implantable device (1) for the closure, sealing and/or repair of an aperture in a human annulus fibrosus, said implantable device (1) comprising a balloon catheter (3) being insertable into nucleus pulposus of said human fibrosus (2) via a cannula in a non-inflated state and inflatable inside the nucleus pulposus.
  • said balloon catheter (3) is viscoelastic and has a woven structure comprising flexible polymeric fibers (7) woven in a biaxial or crisscross fashion.
  • disrupted region in the annulus fibrosus (2) is pluggable by occluder structures connected with said balloon catheter (3) and activated in response to retracting movement of said cannula.
  • said occluder structures incudes an inner occluder (5) and an outer occluder (6) separated by a stent (4) thereinbetween extending along a radial length of the annulus fibrosus (2).
  • said balloon catheter (3) is inflatable inside the nucleus pulposus by delivery of curable elastomeric material or medical grade silicone elastomer.
  • surfaces of said inner and outer occluder (5, 6) structures respectively have at least one dimension larger than a corresponding dimension of a radially innermost portion of the aperture of the annulus fibrosus and radially outermost portion of the aperture of the annulus fibrosus.
  • said stent (4) includes notches and micro-channels to improve adhesion to biological tissue.
  • the mechanical properties of the woven balloon catheter (3) offer protection against being ripped or otherwise damaged during the process of inflation by feeding elastomeric material through the cannula.
  • the inflated balloon catheter (3) can provide the optimum amount of distance between the intervertebral discs. The range of motion of the patient will improve due to the increased flexibility between the discs.

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

Abstract

La présente invention concerne un dispositif d'implant de cathéter tissé pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence. La présente invention concerne plus particulièrement un dispositif implantable (1) pour la fermeture, l'étanchéité et/ou la réparation d'une ouverture dans un anneau fibreux humain, ledit dispositif implantable (1) comprenant un cathéter à ballonnet (3) pouvant être inséré dans le noyau gélatineux dudit fibrosus humain (2) par l'intermédiaire d'une canule dans un état non gonflé et gonflable à l'intérieur du noyau gélatineux.
PCT/EP2018/050164 2018-01-04 2018-01-04 Dispositif d'implant de cathéter pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence WO2019134746A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/EP2018/050164 WO2019134746A1 (fr) 2018-01-04 2018-01-04 Dispositif d'implant de cathéter pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence
TR2018/20233A TR201820233A2 (tr) 2018-01-04 2018-12-24 Hasarli veya bozulmuş bi̇r i̇ntervertebral di̇ski̇n onarilmasi i̇çi̇n kateter i̇mplanti aygiti

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2018/050164 WO2019134746A1 (fr) 2018-01-04 2018-01-04 Dispositif d'implant de cathéter pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence

Publications (1)

Publication Number Publication Date
WO2019134746A1 true WO2019134746A1 (fr) 2019-07-11

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PCT/EP2018/050164 WO2019134746A1 (fr) 2018-01-04 2018-01-04 Dispositif d'implant de cathéter pour restaurer un disque intervertébral endommagé ou présentant une dégénérescence

Country Status (2)

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TR (1) TR201820233A2 (fr)
WO (1) WO2019134746A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114533230A (zh) * 2022-03-17 2022-05-27 中国人民解放军总医院第一医学中心 一种纤维环封堵装置及封堵方法
CN115399855A (zh) * 2022-09-15 2022-11-29 上海交通大学 一种纤维环封堵修复装置

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030074075A1 (en) * 2001-08-27 2003-04-17 Thomas James C. Expandable implant for partial disc replacement and reinforcement of a disc partially removed in a discectomy and for reduction and maintenance of alignment of cancellous bone fractures and methods and apparatuses for same
US20040091540A1 (en) 2000-11-15 2004-05-13 Desrosiers Eric Andre Method for restoring a damaged or degenerated intervertebral disc
WO2005032434A1 (fr) 2003-09-30 2005-04-14 Depuy Acromed, Inc. Procedes et dispositifs pour remplacer le noyau gelatineux des disques vertebraux
US20050245938A1 (en) 2004-04-28 2005-11-03 Kochan Jeffrey P Method and apparatus for minimally invasive repair of intervertebral discs and articular joints
US20070038301A1 (en) * 2005-08-10 2007-02-15 Zimmer Spine, Inc. Devices and methods for disc nucleus replacement
US20070162136A1 (en) * 2005-12-22 2007-07-12 O'neil Michael Nucleus pulposus trial device and technique
US20110282456A1 (en) * 2009-02-05 2011-11-17 Newvert Ltd. Implantable device for sealing a spinal annular fissure tear and method for deploying the same

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040091540A1 (en) 2000-11-15 2004-05-13 Desrosiers Eric Andre Method for restoring a damaged or degenerated intervertebral disc
US20030074075A1 (en) * 2001-08-27 2003-04-17 Thomas James C. Expandable implant for partial disc replacement and reinforcement of a disc partially removed in a discectomy and for reduction and maintenance of alignment of cancellous bone fractures and methods and apparatuses for same
WO2005032434A1 (fr) 2003-09-30 2005-04-14 Depuy Acromed, Inc. Procedes et dispositifs pour remplacer le noyau gelatineux des disques vertebraux
US20050245938A1 (en) 2004-04-28 2005-11-03 Kochan Jeffrey P Method and apparatus for minimally invasive repair of intervertebral discs and articular joints
US20070038301A1 (en) * 2005-08-10 2007-02-15 Zimmer Spine, Inc. Devices and methods for disc nucleus replacement
US20070162136A1 (en) * 2005-12-22 2007-07-12 O'neil Michael Nucleus pulposus trial device and technique
US20110282456A1 (en) * 2009-02-05 2011-11-17 Newvert Ltd. Implantable device for sealing a spinal annular fissure tear and method for deploying the same

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114533230A (zh) * 2022-03-17 2022-05-27 中国人民解放军总医院第一医学中心 一种纤维环封堵装置及封堵方法
CN114533230B (zh) * 2022-03-17 2024-04-02 中国人民解放军总医院第一医学中心 一种纤维环封堵装置及封堵方法
CN115399855A (zh) * 2022-09-15 2022-11-29 上海交通大学 一种纤维环封堵修复装置

Also Published As

Publication number Publication date
TR201820233A2 (tr) 2019-07-22

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