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WO2024256536A1 - Dispositifs portatifs et procédés de stabilisation immédiate d'implant - Google Patents

Dispositifs portatifs et procédés de stabilisation immédiate d'implant Download PDF

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Publication number
WO2024256536A1
WO2024256536A1 PCT/EP2024/066357 EP2024066357W WO2024256536A1 WO 2024256536 A1 WO2024256536 A1 WO 2024256536A1 EP 2024066357 W EP2024066357 W EP 2024066357W WO 2024256536 A1 WO2024256536 A1 WO 2024256536A1
Authority
WO
WIPO (PCT)
Prior art keywords
recess
handgrip
guide pin
backside
ultrasonic horn
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/EP2024/066357
Other languages
English (en)
Inventor
Pierre Henri Christian PERTHAIN
Samuel KALLMEYER
Christian Paul FREI
Delphine BARD
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.)
Nexilis AG
Original Assignee
Nexilis AG
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 Nexilis AG filed Critical Nexilis AG
Publication of WO2024256536A1 publication Critical patent/WO2024256536A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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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
    • A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
    • 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
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • 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
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • 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
    • A61B17/8897—Guide wires or guide pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • A61B2017/00402—Piezo electric actuators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth

Definitions

  • the present invention relates to devices and methods for minimally invasive immediate implant stabilization in a recess, in particular in a recess of porous bone structure.
  • a further disadvantage is that the liquefiable material cannot be introduced in a sufficiently targeted manner into the desired areas and often is dislocated and disappears, for example, in large recesses arranged at the bottom of the recesses, without in the end contributing to the actual primary stabilization.
  • US 3,919,775 describes a method for filling and preparing openings with the aid of a liquefiable material which is initially pressed into the opening and which is then liquefied with the aid of a sonotrode, that is to say a device with which mechanical energy in the form of ultrasound can be introduced.
  • the liquefied material then flows into cavities adjoining the recess and closes these cavities.
  • technical materials such as wood, plastics, foams, etc. are processed, such techniques are also known in the widest sense.
  • the guide pin is received movably in the central recess such that, when mechanical energy is applied, the cylindrical collar can be moved relative to the guide pin in the direction toward the bottom of the recess while liquefying (including plasticizing) and laterally and/or longitudinally displacing the material of an amelioration sleeve made from a material that can be liquefied (including plasticized) by mechanical energy and which material of the amelioration sleeve is surrounding said guide pin.
  • the ultrasonic horn is mounted in the handgrip in a vibration damping manner, preferably in that there is an axial or radial interspace between a preferably cylindrical wall portion of the housing and there is provided at least one vibration damping mounting element in that radial or axial interspace, preferably a series of vibration damping mounting elements along the axial direction of the handgrip, wherein preferably the vibration damping mounting element is selected as an elastic O-Ring
  • a backside portion of the handgrip there is provided, in the housing or as part thereof, a backside guiding element with a through opening for the guide pin as well as the wire, wherein preferably this backside guiding element can be made from the same material as the ultrasonic horn or the housing and/or is mounted by at least one vibration damping mounting elements in the housing or is part of the housing.
  • sealing elements are provided, in particular at the interface between a front opening of the housing and a lateral front contact portion or an edge portion thereof of the ultrasonic horn, and wherein preferably in addition, in the presence of a backside guiding element , there are provided sealing elements at the interface between a backside opening of the housing and a backside or radial surface of the backside guiding element.
  • the cannulation of the ultrasonic horn is provided with a mounting tube, which preferably extends between a tip portion of the ultrasonic horn and a backside opening of the housing and/or the backside opening, in the presence of a backside guiding element, of such backside guiding element, wherein preferably said mounting tube is made of a polymer material, preferably partly or fully halogenated polymer material, most preferably PTFE material.
  • This mounting tube has the following two effects: it can be used for further decoupling of the vibrational energy between the guide pin and/or the (K-)wire and the ultrasonic horn, but it also can be used for optimum sealing not only of the interior of the housing but also of the through opening of the ultrasonic horn.
  • the mounting tube can be sealed by way of circumferential sealing elements at least at the front opening of the ultrasonic horn, where the mounting tube is essentially flush with a front extension of the ultrasonic horn, and/or preferably the mounting tube is sealed by way of circumferential sealing elements with respect to the housing or, if present, with respect to a backside guiding element.
  • the housing can be provided with at least one venting opening.
  • housing can be sealed and any cavity thereof can be filled with inert gas, in particular nitrogen gas.
  • the proposed handgrip comprises a bar shaped element essentially coaxial with the cylindrical collar as well as, branching off from that bar shaped element, preferably under an angle in the range of 90-60°, a gripping extension to be held by the user, wherein preferably said gripping extension is provided with manual actuating elements for controlling the energy transmitted by the cylindrical collar.
  • the guide pin is made of synthetic polymer material, preferably of a thermoplastic material, in particular PTFE and/or PFA, which optionally can be radio-opaque, and/or wherein the guide pin has an outer diameter in the range of 1.5-10 mm, preferably in the range of 2-4 mm, particularly preferably in the range of 2.5-3.5 mm, and wherein diameter of the cannulation is in the range of 0.5-3 mm, preferably in the range of 1-2 mm, particularly preferably in the range of 1.3-1.75 mm.
  • synthetic polymer material preferably of a thermoplastic material, in particular PTFE and/or PFA, which optionally can be radio-opaque
  • the guide pin has an outer diameter in the range of 1.5-10 mm, preferably in the range of 2-4 mm, particularly preferably in the range of 2.5-3.5 mm, and wherein diameter of the cannulation is in the range of 0.5-3 mm, preferably in the range of 1-2 mm, particularly preferably in the range of 1.3-1
  • the external diameter of the collar can be in the range of 1-80 mm, preferably in the range of 2-10 mm, and the external diameter of the guide pin can be 0.1 - 20 mm less, preferably 0.1-2 mm or 0.5-1 mm less.
  • the amelioration sleeve can have a thickness such that the external diameter thereof is the same as the external diameter of the collar and the internal diameter preferably larger than the external diameter of the guide pin, wherein the amelioration sleeve, at least in some sections, preferably has a wall thickness in the range of 0.1-1 mm, preferably in the range of 0.2-0.6 mm.
  • the proposed handgrip generates mechanical energy in the form of vibration energy and/or oscillation energy with frequencies in the range of 1 kHz - 10 GHz, preferably in the form of ultrasonic oscillations in the frequency range of 10 kHz - 100 MHz or 20-150 kHz, particularly preferably in the range of 20 - 70 or 20-40 kHz, which are transmitted in the longitudinal, transverse or rotational direction, or in a combination or linear combination of these directions, preferably substantially exclusively in the longitudinal direction, to the collar (and/or guide pin) and thus (indirectly) to the amelioration sleeve.
  • the wire is typically a preferably sterilized stainless steel pin, preferably having a sharpened tip at least at one end, with preferably circular cross-section over essentially its full-length, and having a diameter in the range of 0.4-3 mm, preferably in the range of 0.9-1.9 mm, more preferably in the range of 1.25-1.7 mm.
  • the present invention relates to a method for operating a handgrip as detailed above. That method can be a surgical or non-surgical method.
  • the method is characterized in that a wire is centrally inserted into a recess and pushed into the very bottom thereof, if needed the inner surface of the recess is prepared for amelioration by using a reamer with a central cannulation, which cannulation is pushed over said wire for controlled insertion of the reamer into the recess, the reamer being rotated when positioned in/advanced into the recess until the desired preparation of the recess is terminated, and subsequently the reamer is taken out while keeping the wire in place, if needed an insertion device having an amelioration sleeve mounted at the distal tip portion thereof and having a central cannulation is pushed with said cannulation over said wire for controlled insertion of the insertion device with the amelioration sleeve into the recess and positioning the amelioration sleeve in the bottom region of the recess, and subsequently taking out the insertion device while keeping the amelioration sleeve in the recess and keeping the wire in
  • the method is a non-surgical method.
  • the recess is normally a recess in an at least partially porous technical material, including wood or wood-like material, or foam material, particularly a polymer foam, a composite foam and/or a metal foam, or in an at least partially dead or living porous human or dead or living animal bone section, particularly in a jaw bone or a spinal column bone, and in that the recess is preferably generated at least partially by preliminary drilling.
  • Fig. 1 shows the kit of parts
  • Fig. 2 shows the individual steps when using the device for amelioration of an opening
  • Fig. 3 shows a first embodiment of a handgrip according to the invention in a schematic axial cross-section with mounted sonotrode and backside guiding element, with guide pin and K-wire inserted;
  • Fig. 4 shows a second embodiment of a handgrip according to the invention in a schematic axial cross-section with a separate mounting tube and backside guiding element;
  • Fig. 6 shows a fourth embodiment of a handgrip according to the invention in a schematic axial cross-section with venting openings.
  • Fig. 1a shows an immediate stabilization system with the components for the immediate stabilization augmentation process.
  • the ultrasonic (US) generator 1 , the handgrip 2 with a covering ring 3 (optional), the sonotrode 4 (collar) and the ISS (immediate stabilization system) sleeve 7 together with the guide pin 8 represent the core-components of the system.
  • the US generator 1 supplies the handgrip 2 (converter) via cable 1a (e.g. sealed to the housing) with electrical power of the required amplitude and frequency, which then is converted in the handgrip 2 into a mechanical oscillation.
  • the mechanical oscillation is directed to the sonotrode 4 that oscillates with a particular amplitude and supplies the (non- resorbable or resorbable, e.g. polylactide) ISS sleeve 7 with the power/energy necessary for melting the material and displace it into the adjacent trabecular bone structure. Pre- clinical tests have shown that this leads to an enhanced mechanical stability of the surrounding bone structure.
  • the system may include an insertion device 5, a reamer 6, the cleaning device 9 and a torque key 10.
  • the ultrasound generator can be controlled by the operator using a foot pedal 11 (or alternatively a control on the handgrip) controlling the amount of energy generated by the ultrasound generator and transferred to the handgrip 2 and transmitted to the sonotrode 4.
  • Fig. 1 b) shows a different embodiment, where the handgrip 2 as opposed to the bar shaped design in Fig. 1a is provided, apart from the bar shaped element 2a which is axial with the sonotrode 4, with a pistol grip like gripping extension 2b for the user to grip by the hand during operation.
  • That gripping extension 2b is typically aligned relative to the bar shaped 2a element of the handgrip 2 under an angle in the range of 60-90°, and the gripping extension 2a may have manipulation elements to control the US generator, i.e. to control duration and/or amplitude of the ultrasonic vibration generated at the sonotrode.
  • An advantage of this design is inter alia that the cable 1a can be routed via the end of this gripping extension 2a which makes manipulation easier and more intuitive.
  • the handgrip 2 may comprise electronics and even control, to allow for control lights, control displays etc. Also illustrated in that Fig. 1 b) is that the handgrip 2 is cannulated over the full length of the bar shaped 2a element for the guide pin 8 as well as for the K-wire 52 as will be detailed further below.
  • the method comprises a step of pedicle opening in the vertebra element 53 and channel preparation. Once the access to the pedicle has been exposed, a channel has to be created through the pedicle by means of any standard surgical procedure. To enable a guided operation procedure, a K-wire (Kirschner Wire) 52 is introduced into the existing channel 56.
  • the method then typically comprises a step of implant bed preparation as illustrated in Fig. 2b).
  • the existing pedicle channel is expanded in diameter by means of the ISS reamer 6 for ensuring a precise implant bed. Therefore, the ISS reamer 6 is guided over the previously placed K-wire 52.
  • the reamer 6 is slightly pressed forward, into the pedicle channel, while it is rotated until the final placement depth of the pedicle screw is reached. The final depth can be recognized by the depth scale which can be provided on the shank of the reamer.
  • the next optional step as illustrated in Fig. 2c) is the step of ISS sleeve placement.
  • the ISS sleeve 7 is attached to the smaller cylinder at the tip of the ISS insertion device 5.
  • the ISS sleeve 7 is placed at the bottom of the implant bed by means of the insertion device 6, guided over the K-wire 52, controlling the insertion depth by the markings on the insertion device 6. Subsequently, the ISS insertion device 6 can be easily removed, leaving the ISS sleeve 7 on its place.
  • the depth scale indicates at which depth the ISS sleeve should be placed referring to the length of the later implanted pedicle screw and in relation to the prepared implant bed depth (by the reamer). Alternatively, the guide pin is placed and then thereafter manually the sleeve is shifted over the guide pin.
  • the ISS guide pin 8 is inserted into the implant bed and through the ISS sleeve 7 at the end of the pedicle channel.
  • the accurate positioning is ensured by the positioned K-wire 52. Due to the cannulation of the handgrip 2 the guiding pin 8 can also be much longer than illustrated in that figure, such that it penetrates substantially into and even beyond the handgrip 2 (see also Fig. 1a).
  • the next step can be the step of temporary removal of the K-wire, as illustrated in Fig. 2f). However, that step is not necessary, in order to perform the ISS melting process, the K-wire 52 can also stay in place, also due to the cannulation of the handgrip 2.
  • the sonotrode 4 on the handgrip 2 is placed slightly over the ISS sleeve 7 inside the implant bed.
  • the sonotrode 4 should be free from any fixation or other external forces for ensuring a successful settling of the sonotrode ultrasound oscillation.
  • the sonotrode is already in contact with the sleeve when ultrasound is activated (the sonotrode is used to push the sleeve down the implant bed before activating ultrasound).
  • a significant advantage of the full cannulation of the handgrip in this phase is that the K-wire 52 can stay in place fully surrounded by the guide pin 8 penetrating through the handgrip 2, leading to an optimum positioning and without problems keeping the K-wire 52 in place due to the ultrasound insulation between handgrip 2 and K-wire 52 by way of the guide pin 8. Insulation in the transducer can also be ensured by means of the mounting tube discussed below.
  • the ultrasound energy is activated by operating the foot pedal or via an actuator on the handgrip 2.
  • the sonotrode 4 needs to be slightly pressed down for melting the ISS sleeve 7 into the surrounding trabecular bone structure.
  • the ultrasound oscillation will continue as long as the foot pedal/an actuator on the handgrip is operated but typically not longer than 5-8 seconds, depending on the dimensions of the sleeve.
  • a depth scale is provided at the lateral surface of the sonotrode 4, indicating the depth which has to be integrated into the bone for ensuring a successful melting of the entire ISS sleeve.
  • the molten polymer is re-solidified.
  • the sonotrode 4 will be detached from the molten ISS sleeve and the sonotrode 4 can be easily removed from the implant bed.
  • the ultrasound energy is activated shortly to detach the sonotrode from the solidified polymer.
  • the next step can be a step of re-insertion of the K-wire 52 as illustrated in Fig. 2k) if the K-wire 52 has been removed temporarily. After the ISS melting process has successfully been completed, the K-wire in this case can be re-positioned through the remaining guiding pin 8.
  • the guiding pin 8 is removed from the implant bed via the inserted K-wire 52.
  • the K-wire 52 has not been removed during the ultrasonic treatment with a cannulated handgrip 2, this step can be omitted and at the same time the sonotrode 4 and the guide pin 8 can be removed in the step as illustrated in Fig. 2i) in a backwards motion while keeping the K-wire 52 in place in the opening to be ameliorated.
  • the step of pedicle screw implantation as shown in Fig. 2I).
  • the pedicle screw 55 implantation can now be done, following the usual standard surgical procedure for the corresponding implant system.
  • Fig. 2m shows the finally augmented pedicle screw.
  • Fig. 3 shows a first embodiment of a handgrip 2 according to the present invention.
  • the sonotrode 4 is mounted on the handgrip 2.
  • the sonotrode 4 has an outer external tip diameter 41 and is provided with a circular cylindrical central recess 42 for receiving the guiding pin 8.
  • the guiding pin 8 itself has an axial central cannulation 43 for the K-wire 52.
  • the guiding pin 8 and the K-wire 52 extent not only through the sonotrode 4 but also through the whole of the handgrip 2 as can be seen in that illustration.
  • the sonotrode 4 Is mounted on the handgrip 2 in such a way that it is attached and firmly secured to an ultrasonic horn 12, which is located in the housing 13 of the handgrip.
  • This ultrasonic horn 12 is used for amplifying the ultrasonic vibrations which are initially generated by the circular piezoelectric elements 16 which sit on and enclose a backside extension 21 of the ultrasonic horn 12.
  • This backside extension 21 follows on a main portion 22 of the ultrasonic horn 12, which main portion has a larger diameter than the backside extension 21.
  • a radial shoulder 23 on which the frontmost circular piezoelectric element is abutting.
  • the ultrasonic horn 12 is provided with a front extension 17 which acts as an interface to the sonotrode 4.
  • the front extension is provided with an external threading to cooperate with an internal threading provided on a backside recession 18 of the sonotrode 4.
  • the sonotrode 4 is screwed onto the ultrasonic horn by way of this interface 17/18, typically such that the backside radial surface of the sonotrode 4 firmly abuts and contacts a lateral front contact portion 20 of the ultrasonic horn 12.
  • This way the ultrasonic waves are not only guided by the ultrasonic horn 12 but also amplified in that element and also, by way of corresponding converging structuring of the sonotrode 4, also by that sonotrode 4.
  • the sonotrode by way of the interface 17/18 can be replaced and/or repaired and/or exchanged depending on what kind of diameters etc. are needed rather easily.
  • the handgrip is fully cannulated and so is the ultrasonic horn 12 including its main portion 22 and the backside extension 21.
  • the backside extension 21 At the backside of the backside extension 21 to facilitate insertion of the guiding pin from the backside that can be provided a funnel structure 25 as illustrated in that figure.
  • Both the ultrasonic horn 12 as well as the backside guiding element 26 are mounted such that between their outer circumference and the cylindrical wall of the housing 48 there is an interspace 14.
  • the ultrasonic horn 12 and the backside guiding element are mounted in that cylindrical wall by way of vibration damping mounting elements 15 of the ultrasonic horn and optional vibration damping elements 27 of the backside guiding element 26, respectively. Vibrations generated by the ultrasonic horn are thereby optimally damped relative to the housing facilitating manipulation without disturbing vibrations of the handgrip.
  • the backside guiding element 26 is provided with a cannulation 43 such that the guiding pin 8 as well as the K-wire 52 can extend and penetrate through the full handgrip 2.
  • the housing to this and has a front opening 19 and a backside opening 28.
  • Fig. 4 shows another embodiment of the proposed handgrip.
  • the cannulation in the handgrip is not directly an exposed part of the ultrasonic horn and/or the backside guiding element, but there is a mounting tube 29 which is located in the respective openings 43 and 45.
  • a mounting tube 29 is located in the respective openings 43 and 45.
  • One problem with handgrips of this type can be corrosion induced by remnant humidity from cleaning and sterilization processes. This may affect any metal surface which is not protected, and one possibility to tackle that problem is the provision of a mounting tube 29 as illustrated in that Fig. 4.
  • the mounting tube extends between the very top portion of the ultrasonic horn 12, i.e.
  • sealing elements 30 typically abuts with the front surface of the front extension 17, where it is sealingly connected to the ultrasonic horn extension 17 by way of sealing elements 30, for example O-rings.
  • the mounting tube 29 abuts with the backside opening 35 of the backside guiding element 26, and also there sealings are provided in the form of sealing rings 36.
  • further sealing elements 32 are provided at the interface between the housing 13 and the radial outer portion of the backside guiding element.
  • Alternatively, also a sealing to the backside of the backside element is possible.
  • On the front side further sealing elements 31 are provided at the interface between the housing wall 13 and in the region of the radial outer edge of the lateral front contact portion 20 of the ultrasonic horn.
  • a sleeve 40 between the piezoelectric ring elements and the cylindrical outer surface 46 of the backside extension 21 there is provided a sleeve 40 between the piezoelectric ring elements and the cylindrical outer surface 46 of the backside extension 21.
  • this can be a heat shrinking sleeve to provide for optimum conditions.
  • the backside extension 21 extends in a backside direction beyond the piezoelectric rings. It is also possible that in this protruding portion the diameter of the backside extension 21 is increasing again or that a ring of ultrasonic horn material is mounted on that backside portion 24. The corresponding mass can act as a counter mass for balancing of the total ultrasonic horn to provide for optimum resonating conditions.
  • the hollow space in the housing 13 in this case is sealed by the sealing element combination 30-32 as well as 36, and to increase protection also the void space in the housing can be filled with an inert gas.
  • Fig. 5 shows another embodiment similar to the one illustrated in the preceding figure.
  • the backside guiding element 26 is omitted.
  • the mounting tube 29 extends to a small and narrow backside opening 28 of the handgrip, and again at this terminal position sealing elements 37 are provided to make sure that the void space is safe in case of sterilization and subsequent cooling in particular.
  • venting openings 38 are provided in the wall of the housing 13, so that any humidity accumulated or generated during or after cleaning and sterilization can escape and will not generate corrosion problems. Venting openings are preferably designed in such a way that the operator cannot get in direct contact with the inner parts and so that cleaning of pollution from the surgery/during use is possible.

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

Abstract

Une poignée (2) pour l'amélioration d'un évidement (56) et pour générer ou coupler en énergie mécanique un collier cylindrique (4) avec une surface d'enveloppe cylindrique ayant un diamètre externe et ayant un évidement central (42) pour recevoir une broche de guidage (8), la broche de guidage (8) étant reçue de façon mobile dans l'évidement central (42), ladite poignée (2) étant canulée sur toute sa longueur axiale pour permettre l'insertion et la pénétration complète de ladite broche de guidage (8) ainsi que, s'il est présent, un fil (52) dans une canulation (43) de la broche de guidage (8), pour un positionnement précis dans le trou à améliorer, ladite poignée comprenant un boîtier (13) dans lequel est monté une corne à ultrasons (12), ladite corne à ultrasons (12) étant canulée sur toute sa longueur axiale pour permettre l'insertion et la pénétration complète de ladite broche de guidage (8) et la corne à ultrasons (12) au moins sur une partie de sa longueur axiale étant pourvue d'au moins un élément piézoélectrique générant des vibrations ultrasonores en forme d'anneau (16).
PCT/EP2024/066357 2023-06-16 2024-06-13 Dispositifs portatifs et procédés de stabilisation immédiate d'implant Pending WO2024256536A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23179868 2023-06-16
EP23179868.7 2023-06-16

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WO2024256536A1 true WO2024256536A1 (fr) 2024-12-19

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3919775A (en) 1971-12-30 1975-11-18 Oscar Malmin Endodontic sealing system and apparatus
US6204592B1 (en) 1999-10-12 2001-03-20 Ben Hur Ultrasonic nailing and drilling apparatus
EP1363543A1 (fr) 2001-03-02 2003-11-26 Woodwelding AG Implants, dispositif et procede permettant de relier des parties de tissu
US20080039845A1 (en) 2006-02-07 2008-02-14 Bonutti Peter M Methods and devices for intracorporeal bonding of implants with thermal energy
WO2009141252A1 (fr) 2008-05-21 2009-11-26 Nexilis Ag Dispositif et procédé pour apporter des améliorations à des cavités
WO2017102433A1 (fr) 2015-12-15 2017-06-22 Nexilis Ag Dispositifs pour stabilisation d'implant immédiate mini-invasive
CN212307953U (zh) 2020-04-16 2021-01-08 桂林市锐锋医疗器械有限公司 防水换能器
CN217310486U (zh) 2022-03-31 2022-08-30 重庆西山科技股份有限公司 换能器及超声骨刀手柄

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3919775A (en) 1971-12-30 1975-11-18 Oscar Malmin Endodontic sealing system and apparatus
US6204592B1 (en) 1999-10-12 2001-03-20 Ben Hur Ultrasonic nailing and drilling apparatus
EP1363543A1 (fr) 2001-03-02 2003-11-26 Woodwelding AG Implants, dispositif et procede permettant de relier des parties de tissu
US20080039845A1 (en) 2006-02-07 2008-02-14 Bonutti Peter M Methods and devices for intracorporeal bonding of implants with thermal energy
WO2009141252A1 (fr) 2008-05-21 2009-11-26 Nexilis Ag Dispositif et procédé pour apporter des améliorations à des cavités
WO2017102433A1 (fr) 2015-12-15 2017-06-22 Nexilis Ag Dispositifs pour stabilisation d'implant immédiate mini-invasive
CN212307953U (zh) 2020-04-16 2021-01-08 桂林市锐锋医疗器械有限公司 防水换能器
CN217310486U (zh) 2022-03-31 2022-08-30 重庆西山科技股份有限公司 换能器及超声骨刀手柄

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