WO2015079283A1 - Dispositif d'injection pour introduire un matériau biocompatible dans des zones anatomiques profondes - Google Patents

Dispositif d'injection pour introduire un matériau biocompatible dans des zones anatomiques profondes Download PDF

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Publication number
WO2015079283A1
WO2015079283A1 PCT/IB2013/055522 IB2013055522W WO2015079283A1 WO 2015079283 A1 WO2015079283 A1 WO 2015079283A1 IB 2013055522 W IB2013055522 W IB 2013055522W WO 2015079283 A1 WO2015079283 A1 WO 2015079283A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannulated body
previous
piston
bone
radiopaque
Prior art date
Application number
PCT/IB2013/055522
Other languages
English (en)
Inventor
Robert Masson
Renzo Soffiatti
Giovanni Faccioli
Original Assignee
Tecres S.P.A.
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 Tecres S.P.A. filed Critical Tecres S.P.A.
Priority to PCT/IB2013/055522 priority Critical patent/WO2015079283A1/fr
Publication of WO2015079283A1 publication Critical patent/WO2015079283A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8811—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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 ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7094—Solid vertebral fillers; devices for inserting such fillers
    • A61B17/7095—Solid vertebral fillers; devices for inserting such fillers the filler comprising unlinked macroscopic particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8825—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by syringe details

Definitions

  • the present invention concerns an injector device for introducing biocompatible material into deep anatomical areas .
  • the present invention concerns an injector device for introducing bone paste or other bone materials or bone cements at the spine, pelvis, rachis, etc. level.
  • injector devices for biocompatible or biological bone materials.
  • injector devices that are able to reach deep or difficult locations, like for example spinal locations.
  • the injector devices conventionally used comprise a tubular duct made from elastically deformable material, capable of easily reaching the injection site, connected to a syringe or to another container filled with the material to be injected and equipped with a piston capable of generating a force that presses the material to be injected to cause it to be delivered into the site of interest.
  • Such devices are often connected to vacuum sources or to external devices capable of generating the force necessary to deliver even relatively fluid and viscous materials .
  • the containers of material are often disconnected from the actual injection cannulas, therefore requiring numerous connection and adaptation portions that must withstand the pressures, which may even be high, to which the material is subjected to cause it to be delivered.
  • the technical task of the present invention is therefore to devise an injector device for introducing biocompatible material into deep anatomical areas.
  • a particular purpose of the present invention is to make an injector device that is simple to make and use and quick to use.
  • a further purpose of the present invention is to devise an injector device that is minimally invasive and that allows easy insertion inside deep anatomical locations. This task and these purposes are accomplished by the injector device for introducing biocompatible material into deep anatomical areas according to the attached claim 1.
  • FIG. 1 is a side view of the injector device for introducing biocompatible material into deep anatomical areas, according to the present invention, in which one of its components is illustrated in an intermediate position;
  • FIG. 2 is a side view of the injector device illustrated in figure 1, in which one of its components is illustrated in an end stop position;
  • FIG. 3 is a side view of a component of the injector device illustrated in figures 1 and 2;
  • - figure 4 is a side view of a further component of the injector device illustrated in figures 1 and 2;
  • - figure 5 is an enlarged side view of a detail of the component of figure 4;
  • FIG. 6 is a perspective view of an element of the component according to figures 4 and 5.
  • an injector device for introducing biocompatible material into deep anatomical areas is wholly indicated with 1.
  • the deep anatomical areas are at the spine, the pelvis, the rachis and at other similar locations .
  • the biocompatible material injected through the device 1 comprises osteoinductive material, biological material, bone paste, bone material, bone substitute material, bone substitutes in general, demineralised bone matrix (DBM) , mixtures thereof and similar materials suitable for the purpose.
  • a biocompatible material can also comprise synthetic bone materials, synthetic biological adduct, bone cement, etc .
  • Such a biocompatible material has a pasty and/or gellike consistency; the consistency of the biocompatible material is viscous.
  • Such a biocompatible material can contain particles or granules of demineralised bone or of synthetic granular material; such particles or granules have dimensions that can reach 15 mm in diameter; in a version of the invention, such particles or granules have dimensions comprised between 1 mm and 5 mm.
  • a surgical technique in which the device according to the present invention is used, foresees to arrange the biocompatible, possibly osseoinductive, material between two adjacent vertebrae.
  • the injector device 1 has a syringe configuration that, due to its dimensions and its operation, satisfies the needs indicated above.
  • the injector device 1 comprises a cannulated body 2.
  • the cannulated body 2 has a distal end 3, facing towards the user, and a proximal end 4, facing towards the injection site.
  • the cannulated body 2 also has an inner lumen 5 and a tubular configuration having a main longitudinal axis 10.
  • the cannulated body 2 has a length such that the injector device 1 is suitable for passing through the soft tissues to reach the deep anatomical location at which the injection has to take place.
  • the injector device 1 is inserted through the same surgical tunnel made to remove the disc residues before the injection of the biocompatible material.
  • the length of the injector device 1 and of its cannulated body 2 is such as to allow the extrusion of the biocompatible material, in a controlled manner, from outside the body of the patient.
  • the injector device 1 comprises a rectilinear section 9 and an end section 6 that is curved and/or bent. Such an end section 6 is foreseen at the proximal end 4 of the cannulated body 2 and/or of the injector device 1.
  • the end section 6 is positioned between the extrusion mouth 40 and the rectilinear section 9.
  • the presence of the end section 6 that is curved and/or bent allows the orientation of the delivery and of the positioning of the biological material.
  • the end section 6 has an angle of curvature 11, with respect to the main longitudinal axis 10 of the rectilinear section 9 of the cannulated body 2.
  • the angle 11 is comprised between 15° and 45° or between 5° and 70° or between 0° and 90°.
  • such an end section 6 has an inclination equal to an angle 11 of 30°.
  • the cannulated body 2 is integral, monolithic and a monoblock. Therefore, the rectilinear section 9, the end section 6 and the extrusion mouth 40 are made in a single continuous piece.
  • connection means that, in the prior art, are used to connect the syringe means for expelling the material to cannulas of various materials and configurations that are used to reach the insertion site, which often has a deep or difficult-to-reach position.
  • the delivery can take place, as explained in greater detail hereafter, by making all of the material contained in the device itself come out, by carrying out the complete emptying of the cannulated body 2 up to its proximal end 4.
  • the device 1 of the present invention optimal delivery conditions are ensured even of fluid and/or granular material.
  • the operator actuates the device 1 from a safety distance, necessary so as not to be subjected to too much radiation .
  • the cannulated body 2 has dimensions and materials that are selected so as to give the device 1 itself a good rigidity. In this way, it is made easier to correctly deliver and arrange the biocompatible material in the anatomical injection site, preventing the end section 6 being able to accidentally straighten or change angle of inclination under the action of the forces that deliver the material itself.
  • the cannulated body 2 does not risk losing the direction of curvature or of varying it during use, ensuring the delivery of the material to the desired site.
  • the cannulated body 2 of the injector device 1 is rigid and is made from a rigid material; once it is made, it has a configuration that cannot be modified or deformed any more by the user.
  • the material with which the cannulated body 2 is made comprises a biocompatible metal, such as titanium, steel, AISI 316, etc., or a neutral or radiopaque plastic resin, or a material suitable for the purpose or a mixture thereof.
  • the injector device 1 also comprises a piston 7 connected to a shaft 8.
  • the piston 7 is made from radiopaque material, so that, during injection, it is always possible to view, through routine viewing techniques, the exact point at which the piston 7 is located.
  • the piston 7 has a diameter corresponding to the internal diameter of the cannulated body 2 and of the inner lumen 5 in order to ensure a hermetic seal between the piston itself and the cannulated body 2.
  • the piston 7, as can be seen in figures 5 and 6, is substantially shaped like a plug and is equipped with a stem 7' .
  • Such a stem 7' can be inserted through a threading, or a snap-coupling, or another known technique, into the shaft 8.
  • the shaft 8 is therefore internally hollow or hollow at least at an end thereof in contact with the piston 7.
  • both the piston 7 and the stem 7' are made from radiopaque material, so that during injection it is always possible to view, through routine viewing techniques, their exact position.
  • the shaft 8 of the piston 7 has a smaller diameter than that of the piston 7 or of the inner lumen 5 of the cannulated body 2.
  • the shaft 8 of the piston 7 is graduated, so as to dose the amount of material inserted into the injector device 1 and thereafter the amount of material extruded .
  • the material from which the piston 7 and/or the shaft 8 and/or the stem 1' is made comprises a biocompatible metal, such as titanium, steel, AISI 316, etc., or a neutral or radiopaque plastic resin, or a material suitable for the purpose or a mixture thereof.
  • the material of the shaft 8 is softer than that of the piston 7 or of the stem 7' or of the cannulated body 2.
  • the material from which the shaft 8 is made is a soft plastic resin or a flexible metal or a sheet of harmonic steel, in other words a material that is flexible but still able to withstand the necessary pressure exerted for delivery.
  • the shaft 8 has a rectilinear but flexible configuration. Therefore, the shaft 8, while the piston 7 pushes the material, flexes and is able to follow the path of the cannulated body 2, even in its end section 6 that is curved and/or bent.
  • the delivery mouth 40 can be made from radiopaque material, in order to view its position during delivery, and thus control the exact injection site.
  • the cannulated body 2 can have, in an embodiment of the invention, an element, for example annular in shape, at its proximal end 4. Also in this way, it is possible to make the delivery mouth of the cannulated body 2 itself visible .
  • the material can be made radiopaque by adding barium and/or tungsten and/or tantalum sulphate and/or other suitable materials to the base material.
  • the radiopaqueness can have various degrees of opaqueness to X-rays. Therefore, it is possible to make a piston 7 that is very radiopaque and a cannulated body 2 having slight radiopaqueness. Moreover, it is possible to add radiopaque substances also to the material to be extruded. In this case, it will be possible to control the insertion of the cannulated body 2, possibly follow the positioning of its extrusion mouth 40 thanks to the radiopaque element positioned at it, and see and distinguish both the piston 7 that advances, and the material that is extruded.
  • the radiopaqueness is additional: in other words the areas of juxtaposition between two radiopaque materials are more radiopaque than the starting materials, with the possibility of making it possible to see a radiopaque material sliding inside a further radiopaque material.
  • the end section 6 that is curved and/or bent of the cannulated body 2 has some critical features. Indeed, maintaining its curvature and/or its bend proved critical over time.
  • the end section 6 of the cannulated body 2 is made by deformation and/or hot- bending of the cannulated body, initially made in straight configuration. Such a deformation and/or bending step takes place at about 160°C for a variable time of between 6 and 12 hours and in the absence of humidity .
  • such a deformation and/or bending step takes place using a template or a metallic shape and stainless steel pins, inserted inside the cannulated body 2, in order to maintain its curvature and/or bend in the end section 6 and its internal diameter.
  • the end section 6 of the cannulated body 2 keeps its curvature and/or bend unchanged over time and also following a test heating to 60°C for a time period of three days. Therefore, the end section (6) is undeformable .
  • the injector device 1 also has handgrip means 12, connected to the distal end 3 of the cannulated body 2. Moreover, at the end of the shaft 8 opposite the piston 7 there are further handgrip means 13, corresponding and complementary to the handgrip means 12 positioned on the cannulated body 2.
  • the injector device 1 contains the biocompatible material to be injected.
  • the loading of the injector device 1 takes place through the proximal end 4 thereof. Such loading takes place through at least one immersion of the injector device 1, in particular of its proximal end 4, in a container containing such a material. Due to the viscous and/or granular nature of the biocompatible material, its loading inside the injector device 1 is very arduous.
  • the proximal end 4,. the extrusion mouth 40 and the cannulated body 2 have predetermined dimensions.
  • the cannulated body 2 has an internal diameter, which corresponds to the diameter of the inner lumen 5, not less than 7.5 mm in the case of corpuscular biological material.
  • a diameter in a version of the invention, corresponds to a volume of at least 1.5 ml of biological material.
  • the cannulated body 2 has an internal diameter that corresponds to the diameter of the inner lumen 5, up to 5 mm in the case of biocompatible material in fluid or gel form but without corpuscles or having small sized corpuscles.
  • the extrusion mouth in a version of the invention, can have a different diameter from that of the rectilinear portion 9 or of the end section 6 of the cannulated body 2, for example in cases in which it is necessary to have a widened section for outlet or inlet of the material during loading of the device 1.
  • reducing means to be applied to the extrusion mouth 40 for those situations in which the diameter thereof must be reduced.
  • the fact of obtaining easy loading of the biocompatible material depends on the dimensions of the granules and on the dimensions of the proximal end 4 and of the extrusion mouth 40 of the device itself.
  • its outer diameter is 9.5 mm or 10 mm.
  • the thickness of the wall of the cannulated body 2 has a size comprised between 1 mm and 2.5 mm.
  • the dimensions of the cannulated body 2 of the injector device 1 are decisive for its function and not mere production choices. Indeed, considering that the material to be extruded can have granules of dimensions up to 5 mm or of also other dimensions, the internal diameter of such a cannulated body 2 must have specific dimensions in order to ensure correct delivery of the material, homogeneous filling of the device 1 and a rigidity such as to prevent the end section 6 being able to undergo changes in orientation or inclination, due to the delivery pressure, with the danger of delivering the material to a location that is not wanted or even not suitable for receiving such a material .
  • the injector device 1 according to the present invention is substantially a monoblock and predetermined. Therefore, it is extremely easy to use, without the need to assemble and disassemble its components during the injection of the biological material. In this way, the operating time is reduced, with lower risks and discomfort for the patient. Moreover, the loading of the injector device 1 is extremely simplified, even in the presence of biological material comprising granules of substantial dimensions or that are particularly viscous.
  • the extrusion of the material can be controlled and actuated by the operator located a considerable distance from the patient, with lower risk of exposure to the rays or radiation to which the patient is subjected during the operation.

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

Abstract

La présente invention concerne un dispositif d'injection (1) conçu pour introduire un matériau biocompatible dans des zones anatomiques profondes, positionnées au niveau de la colonne vertébrale, du pelvis, du rachis et d'autres emplacements similaires, comprenant un corps de type canule (2) et un piston (7) pour distribuer le matériau biologique avec une tige (8), lequel corps de type canule (2) a une extrémité distale (3), orientée vers un utilisateur, et une extrémité proximale (4), orientée vers la zone anatomique, lequel corps de type canule (2) comprend une section rectiligne (9), présentant un axe longitudinal (10), une lumière interne (5), et une extrémité proximale (4) qui comprend une ouverture d'extrusion (40) de la matière biologique, ledit corps de type canule (2) comprenant également une section d'extrémité (6) qui est incurvée et/ou pliée au niveau de l'extrémité proximale (4) et ledit corps de type canule (2) étant formé d'un seul tenant et rigide.
PCT/IB2013/055522 2013-07-05 2013-07-05 Dispositif d'injection pour introduire un matériau biocompatible dans des zones anatomiques profondes WO2015079283A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2013/055522 WO2015079283A1 (fr) 2013-07-05 2013-07-05 Dispositif d'injection pour introduire un matériau biocompatible dans des zones anatomiques profondes

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2013/055522 WO2015079283A1 (fr) 2013-07-05 2013-07-05 Dispositif d'injection pour introduire un matériau biocompatible dans des zones anatomiques profondes

Publications (1)

Publication Number Publication Date
WO2015079283A1 true WO2015079283A1 (fr) 2015-06-04

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PCT/IB2013/055522 WO2015079283A1 (fr) 2013-07-05 2013-07-05 Dispositif d'injection pour introduire un matériau biocompatible dans des zones anatomiques profondes

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10042423A1 (de) * 2000-08-30 2002-03-28 Florian Hoegel Vorrichtung zum Applizieren von Knochenmehl
WO2002100282A1 (fr) * 2000-05-02 2002-12-19 Gross R Michael Procede et moyen de cimentation d'un revetement sur la face de la cavite glenoide d'une omoplate
EP1442718A1 (fr) * 2003-02-03 2004-08-04 Biomet, Inc. Appareil d'administration intramédullaire d'un matériau

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002100282A1 (fr) * 2000-05-02 2002-12-19 Gross R Michael Procede et moyen de cimentation d'un revetement sur la face de la cavite glenoide d'une omoplate
DE10042423A1 (de) * 2000-08-30 2002-03-28 Florian Hoegel Vorrichtung zum Applizieren von Knochenmehl
EP1442718A1 (fr) * 2003-02-03 2004-08-04 Biomet, Inc. Appareil d'administration intramédullaire d'un matériau

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