Handheld device and method for immediate implant stabilization

Abstract

A handgrip 2 for improving a recess 56 and for generating or coupling mechanical energy. The handgrip 2 comprises a cylindrical collar 4 having a cylindrical jacket surface having an outer diameter and a central cavity 42 for receiving a guide pin 8. The guide pin 8 is movably housed in the central cavity 42. To precisely position within the hole to be improved, the handgrip 2 is cannular along its entire axial length, allowing the guide pin 8 to be inserted and completely penetrated, and a wire 52, if present, to be inserted and completely penetrated into the cannulation 43 of the guide pin 8. The handgrip comprises a housing 13 to which an ultrasonic horn 12 is mounted. The ultrasonic horn 12 is cannular along its entire axial length, allowing the guide pin 8 to be inserted and completely penetrated. The ultrasonic horn 12 is provided with at least one annular piezoelectric element 16 for generating ultrasonic vibrations along at least a portion of its axial length.

Description

Technical Field

[0001] The present invention relates to devices and methods for minimally invasive immediate implant stabilization in concavities, particularly in porous bone structures.

Background Art

[0002] The fixation of implant systems in osteoporotic bone remains a large market that is still under development by medical device companies. Due to demographic changes in Western European countries, the incidence of osteopenia, osteoporosis, and diabetes has increased significantly, and thus the incidence of osteoporotic bone has also increased. Millions of people in Europe, the United States, and Japan suffer from osteopenia and osteoporosis. Implants developed for good bone quality do not work well in damaged bone, making the treatment of fractures significantly more complicated. The increasing incidence of diabetes is a further problem because it affects bone metabolism due to systemic deficiency of vitamin D. Fractures caused by rare diseases such as osteogenesis imperfecta are also very difficult to treat.

[0003] Particularly, in the field of fixing implants in concavities within the body of a human or animal, for example, in holes drilled in bone, it is known to screw an implant provided with self-tapping threads into such a concavity by applying torque, and then mechanically load the implant while the implant is incorporated into the bone during the process of natural healing.

[0004] Particularly, in the case of a concavity provided in a particularly porous bone portion, the primary stability may be insufficient, so it is also known that the stability of the implant in the concavity immediately after screwing in is insufficient before the actual incorporation process ends.

[0005] To address these problems, it has already been proposed to produce implants, at least partially or even entirely, from materials that can be liquefied and / or plasticized by mechanical energy (see, for example, Patent Document 1). The liquefiable material can be liquefied by mechanical shaking after the implant is inserted into the tissue area, and thus, a morphologically compatible connection is created between the bone and the implant by the material that is re-solidified after liquefaction. The disadvantage of such solutions is that very special implants are required to make such methods implementable. A further disadvantage is that the liquefiable material cannot be introduced with sufficient targeting within the desired area, and is often misplaced, for example, disappearing into a large depression located at the bottom of a depression, and ultimately not contributing to actual primary stability.

[0006] The concept of filling cavities within the human body with liquefiable materials has been known in principle for some time, particularly in the dental field. Therefore, Patent Document 2 describes a method for filling and preparing openings using liquefiable materials, in which the liquefiable material is first injected under pressure into the opening and then liquefied using a sonotrode, a device to which mechanical energy in the form of ultrasound can be introduced. The liquefied material then flows into cavities adjacent to the cavities, closing these cavities. Such techniques are similarly known in the broadest sense in other fields where technical materials such as wood, plastics, and foams are processed.

[0007] Furthermore, Patent Document 3 discloses methods and devices for ameliorating recesses, for example, for preparing recesses for implants to be fastened within them, particularly dental implants.

[0008] In general, in the field of implants, Patent Document 4 provides a method for stabilizing fractured bone. This method includes positioning an elongated rod within the medullary canal of the fractured bone and forming a passage through the bone cortex. The passage extends from the outer surface of the bone to the medullary canal. This method also includes creating a joint region on the elongated rod. The joint region is generally aligned with the cortical passage. Furthermore, this method includes positioning a fastener within the cortical passage and on the joint region of the elongated rod, and thermally bonding the fastener to the joint region of the elongated rod while the fastener is positioned within the cortical passage. In particular, this document discloses the use of a guidewire to introduce the implanted structure into a hole in the bone or tissue. However, it does not disclose the use of a guidewire in positioning secondary tools of the implantation process that are removed after the actual implantation process.

[0009] Patent Document 5 discloses a system for improving depressions, particularly depressions in porous perforated materials having cavities created by the depressions. The system comprises elements for generating or combining mechanical energy and a cylindrical collar having a central cavity for receiving a guide pin. A cannulated guide pin is provided to be inserted substantially to the bottom of the depression, with positioning using a wire before mechanical energy is applied. The guide pin is surrounded by an improvement sleeve in the region of the end of the guide pin that is oriented toward the bottom of the depression. The outer surface of the cylindrical jacket of the improvement sleeve has substantially the same outer diameter as the collar. The guide pin is movably housed in the central cavity, so that when mechanical energy is applied, the collar can move relative to the guide pin toward the bottom of the depression, liquefying the material of the improvement sleeve and displacing it laterally and / or longitudinally.

[0010] Patent Document 6 provides a transducer and an ultrasonic bone cutting handle for use with an ultrasonic bone knife. The transducer comprises a main body and an amplitude conversion rod connected to the front end of the main body. The main body comprises a pre-tightening bolt and a front cover plate, a rear cover plate, and a piezoelectric assembly connected to the pre-tightening bolt. The amplitude conversion rod and the front cover plate are sequentially connected to the front end of the pre-tightening bolt, and the piezoelectric assembly is located between the front cover plate and the rear cover plate. The rear cover plate is connected to the rear end of the pre-tightening bolt, and the rear cover plate is provided with a tightening portion having a hexagonal cross-section. According to this utility model, the versatility of removing and assembling the rear cover plate is improved, and the rear cover plate connected to the pre-tightening bolt can be removed and assembled using a commercially available wrench of the corresponding standard size. In addition, there is no need to process and manufacture a dedicated removal tool, which reduces costs.

[0011] Patent Document 7 proposes an ultrasonic nailing and drilling device for various precision applications such as medical or dental surgery. This device comprises a piezoelectric transducer means that provides axial thrust and a motor that provides rotation to the bit. Thus, this ultrasonic nailing and drilling device combines the advantages of ultrasonic nailing or drilling bits with the advantages of rotary drills. The ultrasonic nailing and drilling device further comprises an elongated horn having a working tip, to which a bit can be fixedly attached. The working tip can be any shape designed for ultrasonic equipment, and can be a flathead screwdriver tip, a Phillips screwdriver tip, or even a shape similar to a conventional drill bit.

[0012] Patent Document 8 relates to a waterproof transducer used in ultrasonic scalers and bone knives. This transducer comprises an amplitude conversion rod, a piezoelectric module, a main rod, a water passage pipe, and two O-rings. The tail end of the amplitude conversion rod is tapered into a tubular insertion rod, and the tail end of the insertion rod is inserted into the main rod from the front end and screw-connected to the main rod. The piezoelectric module is fitted onto the insertion rod and is held between the amplitude conversion rod and the main rod. One end of the water passage pipe enters the insertion rod through the tail end of the insertion rod, and the other end of the water passage pipe extends outside the main rod through the inside of the main rod. The O-rings are positioned between the circumferential surface of the water passage pipe and the inner wall of the insertion rod, and between the circumferential surface of the water passage pipe and the inner wall of the main rod. In this amplitude conversion rod, the piezoelectric module is placed in the insertion rod of the amplitude conversion rod rather than the main rod, resulting in simpler installation of the amplitude conversion rod and improved waterproofing performance. [Prior art documents] [Patent Documents]

[0013] [Patent Document 1] European Patent No. 1363543 [Patent Document 2] U.S. Patent No. 3,919,775 [Patent Document 3] International Publication No. 2009 / 141252 [Patent Document 4] U.S. Patent Application Publication No. 2008 / 039845 [Patent Document 5] International Publication No. 2017 / 102433 [Patent Document 6] China Utility Model No. 217310486 [Patent Document 7] U.S. Patent No. 6204592 [Patent Document 8] China Utility Model No. 212307953 [Overview of the project] [Problems that the invention aims to solve]

[0014] The object of the present invention is to provide an improved handgrip for the process of improving depressions. [Means for solving the problem]

[0015] According to a first aspect of the present invention, the present invention relates to a hand grip for improving depressions, particularly depressions in porous perforated materials having cavities created by depressions, and for generating or combining mechanical energy, comprising a cylindrical collar having a cylindrical jacket surface having an outer diameter and a central cavity for receiving a guide pin.

[0016] The guide pin is movably housed within a central cavity such that, when mechanical energy is applied, the cylindrical collar moves relative to the guide pin toward the bottom of the recess, liquefying (including plasticizing) the material of the improvement sleeve, which is made from a material that can be liquefied (including plasticizing) by mechanical energy, and displacing it laterally and / or longitudinally. The material of the improvement sleeve surrounds the guide pin.

[0017] The guide pin has an axial central through bore in the form of a cannulation for receiving a wire inserted into the cannulation of the guide pin, at least before mechanical energy is applied. The cannulation in the guide pin is for wire only, and / or the cannulation in the handgrip is for the guide pin. Therefore, these cannulations preferably have a relatively small diameter (typically in the range of 0.5 mm to 3 mm for wire, especially K-wire, or in the range of 1.5 mm to 10 mm for guide pins) and are generally unsuitable for guiding liquids. Therefore, the cannulation may have internal sidewalls that are not continuous circumferentially along their entire length and / or do not have sealing properties.

[0018] Also, in order to be accurately positioned within the hole to be improved, the hand grip is cannula-shaped over its entire axial length, allowing the guide pin to be inserted and passed through completely, and also allowing the wire to be inserted into the cannulation of the guide pin and passed through completely.

[0019] The cylindrical collar is usually part of the hand grip, and preferably, at least one of the guide pin and the wire and the improvement sleeve are also part of the hand grip.

[0020] The hand grip is provided for improving an opening and is not suitable as a punching device or a suturing device or a nailing device and is not adapted as such. Also preferably, it does not have a connection for such cutting, erosion, or ablation, or impact applications.

[0021] Furthermore, this hand grip includes a housing (which is held by the user) to which an ultrasonic horn is attached. Usually, such a housing is made of a glass fiber reinforced thermoplastic material. Possible materials include polypropylene (PP), polyamide (PA), polycarbonate (PC), polyvinyl chloride (PCV), polyether ether ketone (PEEK), or a mixture thereof. The housing can consist of two or more parts that are fixed to each other by form fit, force fit, material bonding, or a combination thereof, and thus, for example, by clip connection, groove and comb, screw, adhesion, or welding, or a combination thereof. The two halves of the housing can be divided by an axial or radial plane.

[0022] The ultrasonic horn is cannula-shaped over its entire axial length, allowing the guide pin to be inserted and passed through completely, and also allowing the wire to be inserted into the cannulation of the guide pin and passed through completely.

[0023] The ultrasonic horn is provided with at least one annular piezoelectric element for generating ultrasonic vibrations, extending over at least a portion of its axial length.

[0024] According to a preferred embodiment of the proposed handgrip, two or more annular piezoelectric elements for generating ultrasonic vibrations are provided, preferably the annular piezoelectric elements are located adjacent to one another in the axial direction, and preferably at least two or three or exactly two or three, preferably identical annular piezoelectric elements, are arranged in the axial direction.

[0025] According to a preferred embodiment of the proposed handgrip, at least one annular ultrasonic vibration generating piezoelectric element is provided behind the main body of the ultrasonic horn. The annular ultrasonic vibration generating piezoelectric element(s) are surrounded by, or surround, a rear extension of the ultrasonic horn having a smaller diameter than the main body, and are directly adjacent to a shoulder portion that extends radially between the main body and the rear extension. Preferably, at least one sleeve is provided between the cylindrical outer surface of the rear extension and the cylindrical inner surface of the annular ultrasonic vibration generating piezoelectric element, the sleeve containing or consisting of a polymer damping material, and is preferably a heat-shrinkable sleeve.

[0026] According to a preferred embodiment of the proposed handgrip, the ultrasonic horn is made of titanium or a titanium alloy or steel or a steel alloy and preferably comprises a front extension having an external thread or bayonet lock, the front extension preferably at least partially penetrating beyond the front section of the housing and serving as a connector for mounting a cylindrical collar having a corresponding rear recess having an internal thread or bayonet lock.

[0027] According to a preferred embodiment of the proposed handgrip, the ultrasonic horn is mounted to the handgrip in a vibration-damping manner, preferably with an axial or radial gap between it and a preferably cylindrical wall portion of the housing, and within this radial or axial gap, there is provided at least one vibration-damping mounting element, preferably arranged along the axial direction of the handgrip, preferably the vibration-damping mounting element is selected as an elastic O-ring. According to a preferred embodiment of the proposed handgrip, in the rear portion of the handgrip, a rear guide element is provided in the housing or a part thereof, having a through-opening for a guide pin and wire, preferably, this rear guide element can be made from the same material as the ultrasonic horn or housing and / or is mounted by at least one vibration-damping mounting element within the housing or is part of the housing.

[0028] One significant problem identified with such hand grips is that, in terms of cleaning and sterilization, they are typically exposed to high temperatures and pressures for extended periods. Steam treatment is also frequently used. If the interior of the corresponding hand grip is not sealed, cleaning and sterilization typically lead to condensation inside the housing, ultimately resulting in corrosion of metal parts, particularly ultrasonic horns and / or piezoelectric elements. For this reason, sealing is crucial and is preferably combined with filling the interior with an inert gas. An alternative approach in this regard involves providing vents to allow for complete drying at the end of the cleaning and / or sterilization process.

[0029] In a preferred embodiment of the proposed handgrip, a sealing element is provided between the housing and the ultrasonic horn, particularly at the boundary between the front opening of the housing and the front lateral contact portion or the front contact portion or its edge of the ultrasonic horn. In addition, preferably, if a rear guide element is present, a sealing element is provided at the boundary between the rear opening of the housing and the rear or radial surface of the rear guide element.

[0030] According to a preferred embodiment of the proposed handgrip, the cannulation of the ultrasonic horn is provided with a mounting tube, which preferably extends between the tip of the ultrasonic horn and the rear opening of the housing and / or the rear opening of any rear guide element, if such a rear guide element is present, and preferably the mounting tube is made of a polymer material, preferably a partially or fully halogenated polymer material, most preferably a PTFE material.

[0031] This mounting tube has two effects: it can be used to further isolate vibrational energy between the guide pin and / or (K) wire and the ultrasonic horn; and it can also be used to optimally seal not only the inside of the housing but also the through-opening of the ultrasonic horn.

[0032] The mounting tube can be sealed by a circumferential sealing element at least at the front opening of the ultrasonic horn, the mounting tube is essentially flush with the front extension of the ultrasonic horn, and / or, preferably, the mounting tube is sealed by a circumferential sealing element against the housing, or against the rear guide element, if present.

[0033] Furthermore, the housing may be provided with at least one ventilation opening.

[0034] Furthermore, the housing can be sealed, and its cavity can be filled with an inert gas, particularly nitrogen gas.

[0035] According to a preferred embodiment of the proposed handgrip, the handgrip comprises a cylindrical collar and a rod-shaped element essentially coaxial with it, and a gripping extension branching off from the rod-shaped element at an angle preferably in the range of 90° to 60° for the user to hold, wherein the gripping extension is preferably provided with a manual actuation element for controlling the energy transmitted by the cylindrical collar.

[0036] According to a preferred embodiment of the proposed handgrip, the guide pins are made from a synthetic polymer material, preferably a thermoplastic material, particularly PTFE and / or PFA, and can be radiopaque, and / or the guide pins have an outer diameter in the range of 1.5 mm to 10 mm, preferably 2 mm to 4 mm, particularly preferably 2.5 mm to 3.5 mm, and the diameter of the cannulation is in the range of 0.5 mm to 3 mm, preferably 1 mm to 2 mm, particularly preferably 1.3 mm to 1.75 mm.

[0037] The outer diameter of the collar can be in the range of 1 mm to 80 mm, preferably in the range of 2 mm to 10 mm, and the outer diameter of the guide pin can be 0.1 mm to 20 mm smaller than that, preferably 0.1 mm to 2 mm or 0.5 mm to 1 mm smaller.

[0038] The improved sleeve may have a thickness such that its outer diameter is the same as the outer diameter of the collar, and its inner diameter is preferably larger than the outer diameter of the guide pin. The improved sleeve preferably has a wall thickness in the range of 0.1 mm to 1 mm, preferably 0.2 mm to 0.6 mm, in at least some sections.

[0039] According to a preferred embodiment of the proposed handgrip, the handgrip generates mechanical energy in the form of vibrational and / or oscillating energy having a frequency in the range of 1 kHz to 10 GHz, preferably in the form of ultrasonic oscillation in the frequency range of 10 kHz to 100 MHz or 20 kHz to 150 kHz, particularly preferably in the form of 20 kHz to 70 kHz or 20 kHz to 40 kHz, and the mechanical energy is transmitted to the collar (and / or guide pin) and, by extension (indirectly) to the improvement sleeve in the longitudinal, transverse, or rotational direction, or a combination or linear combination thereof, preferably substantially exclusively in the longitudinal direction.

[0040] The wire is typically, preferably, a sterilized stainless steel pin, preferably having a sharpened tip at at least one end, preferably having a circular cross-section along its entire length, and having a diameter in the range of 0.4 mm to 3 mm, preferably 0.9 mm to 1.9 mm, and more preferably 1.25 mm to 1.7 mm.

[0041] In another aspect, the present invention relates to a method for operating the handgrip described in detail above. This method may be surgical or non-surgical.

[0042] More specifically, this method is The wire is inserted into the center of the recess and pushed to the bottom of the recess. If necessary, the inner surface of the recess is prepared for improvement by using a reamer with a central cannulation, the cannulation being pushed along the wire for controlled insertion of the reamer into the recess, the reamer being positioned / advancing into the recess and rotated until the desired preparation of the recess is complete, the reamer then being withdrawn while maintaining the wire in place. If necessary, an insertion device having an improvement sleeve attached to the distal tip portion of the insertion device and having a central cannulation, for controlled insertion of the insertion device having the improvement sleeve into a recess, the wire is pushed by the cannulation, positioning the improvement sleeve in the bottom region of the recess, and then the insertion device is withdrawn while maintaining the improvement sleeve in the recess and the wire in place, The guide pin is pressed along the wire by or using cannulation of the guide pin until it abuts against the bottom of the recess and / or engages with a guide taper located at the bottom of the recess, where the recess has an inner diameter substantially corresponding to the outer diameter of the collar and the improvement sleeve, and thereafter, by the simultaneous liquefaction (including plasticization) of the improvement sleeve by applied mechanical energy, preferably by applied ultrasound, and by pushing the distal end of the collar into the recess, with the use of a protective sleeve to protect the surrounding soft tissue if necessary, the liquefied (including plasticized) material is introduced into cavities adjacent to the recess, particularly lateral cavities.

[0043] This method is preferably a non-surgical method.

[0044] The depressions are typically depressions in wood or wood-like materials, or foamed materials, particularly in at least partially porous technical materials including polymer foams, composite foams, and / or metal foams, or in porous bone portions of at least partially dead or living humans or dead or living animals, particularly in the jawbone or vertebral bone, and the depressions are preferably at least partially created by pre-drilling.

[0045] Further embodiments of the present invention are described in the dependent claims.

[0046] Preferred embodiments of the present invention are described below with reference to the drawings. The drawings are intended to illustrate, but not to limit, current preferred embodiments of the present invention. [Brief explanation of the drawing]

[0047] [Figure 1] Figure 1 shows a parts kit. [Figure 2] Figure 2 shows the individual steps involved in using a device to improve the opening. [Figure 3] Figure 3 is a schematic axial cross-sectional view showing a first embodiment of the handgrip according to the present invention, with the sonotrode and rear guide element attached and the guide pin and K wire inserted. [Figure 4] Figure 4 is a schematic axial cross-sectional view showing a second embodiment of the handgrip according to the present invention, which includes a separate mounting tube and a rear guide element. [Figure 5] Figure 5 is a schematic axial cross-sectional view showing a third embodiment of the handgrip according to the present invention, which includes a separate mounting tube but does not include a rear guide element. [Figure 6] Figure 6 is a schematic axial cross-sectional view showing a fourth embodiment of the hand grip according to the present invention, which is equipped with a ventilation opening. [Modes for carrying out the invention]

[0048] Figure 1a) shows an immediate stabilization system with components for an immediate stabilization enhancement process. The core components of the system are an ISS (immediate stabilization system) sleeve 7 used with an ultrasonic (US) generator 1, a handgrip 2 with a covering 3 (optional), a sonotrode 4 (collar), and a guide pin 8. The US generator 1 supplies power of the required amplitude and frequency to the handgrip 2 (converter) via a cable 1a (e.g., sealed to the housing), which is converted into mechanical oscillations within the handgrip 2. The mechanical oscillations are induced to the sonotrode 4, which oscillates at a specific amplitude, supplying the necessary force / energy to the ISS sleeve 7 (non-absorbable or absorbable, e.g., made of polylactic acid) to melt the material and displace it within the adjacent cancellous bone structure. Preclinical studies have shown that this leads to improved mechanical stability of the surrounding bone structure.

[0049] Furthermore, the system may include an insertion device 5, a reamer 6, a cleaning device 9, and a torque key 10. Also advantageously, the ultrasonic generator can be controlled by an operator using a foot pedal 11 (or alternatively, a control on the handgrip) to control the amount of energy generated by the ultrasonic generator, transmitted to the handgrip 2, and then transmitted to the sonotrode 4.

[0050] Figure 1b) shows a different embodiment, in which, unlike the rod-shaped design in Figure 1a, a handgrip 2 is provided, which has a pistol-grip-shaped gripping extension 2b for the user to grasp by hand during operation, in addition to the rod-shaped element 2a coaxial with the sonotrode 4. The gripping extension 2b is usually aligned with the rod-shaped element 2a of the handgrip 2 at an angle in the range of 60° to 90°, and the gripping extension 2a may have an operating element for controlling the US generator, i.e., controlling the duration and / or amplitude of the ultrasonic vibrations generated in the sonotrode. An advantage of this design is that operation is easier and more intuitive, in particular, because the cable 1a can be routed through the end of this gripping extension 2a. The handgrip 2 may include electronic circuits and even a control unit, enabling control of lights, displays, etc. Also shown in Figure 1b) is a cannula-like structure extending along the entire length of the rod-shaped element 2a for a guide pin 8 and a K-wire 52, which will be detailed below.

[0051] The proposed minimally invasive improvement methods and devices may be used, as described in detail below with reference to Figure 2.

[0052] As shown in Figure 2a), the method includes the steps of opening the pedicle and preparing the channel in the vertebral element 53. After the access to the pedicle is exposed, it is necessary to form a channel through the pedicle by any standard surgical technique. To enable a guided surgical technique, a K-wire (Kirschner wire) 52 is introduced into the existing channel 56.

[0053] Next, the method typically includes an implant bed preparation step as shown in Figure 2b). The existing pedicle channel is enlarged by the ISS reamer 6 to ensure a precise implant bed. Thus, the ISS reamer 6 is guided over the pre-positioned K wire 52. The reamer 6 is pushed slightly forward into the pedicle channel while rotating until it reaches the final placement depth of the pedicle screw.

[0054] The final depth can be determined by a depth scale that can be placed on the shank of the reamer.

[0055] The next optional step, shown in Figure 2c), is the ISS sleeve placement step. The ISS sleeve 7 is attached to the smaller diameter cylinder at the tip of the ISS insertion device 5.

[0056] Next, as shown in Figure 2d) illustrating ISS sleeve insertion, the ISS sleeve 7 is guided over the K wire 52 using the insertion device 6 and positioned at the bottom of the implant bed, with the insertion depth controlled by markings on the insertion device 6. The ISS insertion device 6 can then be easily removed, leaving the ISS sleeve 7 in place.

[0057] The depth scale indicates the depth to which the ISS sleeve should be positioned relative to the implant bed depth prepared (by a reamer), referring to the length of the pedicle screw to be implanted later. Alternatively, a guide pin is positioned, and then the sleeve is manually displaced onto the guide pin.

[0058] In the next step, as shown in Figure 2e) illustrating the insertion of the guide pin, the ISS guide pin 8 is inserted into the implant bed and passed through the ISS sleeve 7 at the end of the pedicle channel. Precise positioning is ensured by the positioning of the K wire 52. Because the handgrip 2 is cannular, the guide pin 8 can be much longer than shown in this figure, resulting in greater penetration into the handgrip 2 and even beyond the handgrip 2 (see also Figure 1a).

[0059] The next step may be the temporary removal of the K-wire, as shown in Figure 2f). However, this step is not mandatory, and since the handgrip 2 is cannula-shaped, the K-wire 52 may remain in place while the ISS melting process is carried out.

[0060] The next step involves initiating the oscillation of the sonotrode, as shown in Figure 2g). Before the initiation of the US oscillation, the sonotrode 4 on the handgrip 2 is positioned slightly above the ISS sleeve 7 in the implant bed. At the moment of activation, it is preferable that the sonotrode 4 is released from fixation or other external forces to ensure that the ultrasonic oscillation of the sonotrode stabilizes successfully. Typically, the sonotrode is already in contact with the sleeve when the ultrasound is activated (the sonotrode is used to push the sleeve down into the implant bed before the ultrasound is activated). A key advantage of the handgrip being fully cannular at this stage is that the K-wire 52 can be kept in place, completely surrounded by the guide pin 8 that penetrates the handgrip 2. This provides optimal positioning, and because the guide pin 8 provides ultrasonic insulation between the handgrip 2 and the K-wire 52, there are no problems in holding the K-wire 52 in place. Insulation in the transducer can also be ensured by the mounting tube described later.

[0061] In the next step of melting the ISS sleeve, as shown in Figure 2h), ultrasonic energy is activated by operating the foot pedal or via an actuator on the handgrip 2. Simultaneously, the sonotrode 4 needs to be slightly pushed down to melt the ISS sleeve 7 into the surrounding cancellous bone structure. The ultrasonic oscillation continues while the foot pedal or the actuator on the handgrip is operated, but is usually within 5 to 8 seconds, depending on the dimensions of the sleeve. A depth scale is provided on the side of the sonotrode 4 to indicate the depth to which integration into the bone is necessary to ensure successful melting of the entire ISS sleeve.

[0062] In the next step to remove the sonotrode, as shown in Figure 2i), the molten polymer solidifies again approximately 5 seconds after the ultrasonic energy is stopped. By slightly rotating the handgrip 2, the sonotrode 4 is separated from the molten ISS sleeve and can be easily removed from the implant bed. At the same time, it is preferable to separate the sonotrode from the solidified polymer by briefly applying ultrasonic energy.

[0063] If the K-wire 52 has been temporarily removed, the next step may be the reinsertion of the K-wire 52 as shown in Figure 2(k). After the ISS melting process is successfully completed, the K-wire can be repositioned through the remaining guide pin 8. The guide pin 8 is then removed from the implant bed via the inserted K-wire 52. Preferably, if the K-wire 52 has not been removed during ultrasonic treatment using the cannula-shaped handgrip 2, this step can be omitted, and simultaneously, in the step shown in Figure 2(i), the sonotrode 4 and guide pin 8 can be removed while moving backward, with the K-wire 52 held in place within the opening to be improved.

[0064] Next, the step of pedicle screw implantation follows, as shown in Figure 2l). Here, the implantation of the pedicle screw 55 can be performed according to the usual standard surgical procedure for the corresponding implant system.

[0065] Figure 2(m) shows the final enhanced pedicle screw. After the K-wire 52 is removed, the implantation, including the ISS pedicle screw enhancement, is complete.

[0066] Figure 3 shows a first embodiment of the handgrip 2 according to the present invention. In this case, the sonotrode 4 is mounted on the handgrip 2. The sonotrode 4 has a tip outer diameter 41 and is provided with a cylindrical central cavity 42 for receiving a guide pin 8. The guide pin 8 itself has an axial central cannulation 43 for the K wire 52. The guide pin 8 and the K wire 52 pass through the sonotrode 4 as well as the entire handgrip 2, as can be seen in Figure 3.

[0067] The sonotrode 4 is attached to the handgrip 2 in such a way as to be securely fixed to the ultrasonic horn 12 located within the housing 13 of the handgrip. The ultrasonic horn 12 is used to amplify the ultrasonic vibrations initially generated by the circular piezoelectric element 16. The circular piezoelectric element 16 is located in and surrounds the rear extension 21 of the ultrasonic horn 12. This rear extension 21 is provided following the main body 22 of the ultrasonic horn 12, which has a larger diameter than the rear extension 21. Between the main body 22 and the rear extension 21 is a radial shoulder portion 23 against which the foremost circular piezoelectric element abuts. In this case, three identical cylindrical annular piezoelectric elements 16 are aligned axially, with their cylindrical inner surfaces 47 in contact with the cylindrical outer surface 46 of the rear extension 21.

[0068] At the front, the ultrasonic horn 12 is provided with a front extension 17 that functions as a connection point to the sonotrode 4. For this purpose, the front extension is provided with an external thread that cooperates with an internal thread provided in a rear recess 18 of the sonotrode 4. The sonotrode 4 is screwed into the ultrasonic horn by this connection point 17 / 18, so that the rear radial surface of the sonotrode 4 is normally in secure contact with the front lateral contact point 20 of the ultrasonic horn 12. In this way, the ultrasonic waves are not only guided by the ultrasonic horn 12 but also amplified within this element, and are also amplified by the corresponding focusing structure of the sonotrode 4 and by the sonotrode 4 itself. The connection point 17 / 18 allows the sonotrode to be replaced and / or repaired and / or replaced relatively easily, depending on the required diameter and other types.

[0069] As described above, the handgrip is completely cannula-shaped, and the ultrasonic horn 12 is also cannula-shaped, including its main portion 22 and rear extension portion 21. A funnel-shaped structure 25, as shown in Figure 3, can be provided on the rear side of the rear extension portion 21 to facilitate the insertion of a guide pin from the rear.

[0070] An additional rear guide element 26 is provided to ensure that the guide pin and K wire are safely guided into the handgrip at the rear of the housing 13. The rear guide element 26 may also be configured as part of the housing 13.

[0071] Both the ultrasonic horn 12 and the rear guide element 26 are mounted such that a gap 14 exists between their outer circumference and the cylindrical wall 48 of the housing. The ultrasonic horn 12 and the rear guide element are attached to the cylindrical wall by the vibration damping mounting element 15 of the ultrasonic horn and an optional vibration damping element 27 of the rear guide element 26, respectively. This ensures that vibrations generated by the ultrasonic horn are optimally dampened against the housing, making operation easier without interfering vibrations in the handgrip.

[0072] Furthermore, a cannulation 43 is provided in the rear guide element 26, allowing the guide pin 8 and K wire 52 to extend and pass through the entire handgrip 2. For this purpose, the housing has a front opening 19 and a rear opening 28.

[0073] Figure 4 shows another embodiment of the proposed handgrip. In this case, the cannulation within the handgrip is not directly on the exposed portion of the ultrasonic horn and / or rear guide element, but rather there is a mounting tube 29 located within the respective openings 43 and 45. One problem associated with this type of handgrip may be corrosion caused by residual moisture from the cleaning and sterilization process. Since this corrosion can affect unprotected metal surfaces, one possibility to address this problem is to provide a mounting tube 29 as shown in Figure 4. The mounting tube extends between the top of the ultrasonic horn 12, i.e., typically abuts against the front surface of the front extension 17, where it is sealed to the ultrasonic horn extension 17 by a sealing element 30, such as an O-ring. On the rear side, the mounting tube 29 abuts against the rear opening 35 of the rear guide element 26, where a seal is also provided in the form of a sealing ring 36. To provide a complete seal of the internal space gap within the actual housing wall 13, an additional sealing element 32 is provided at the boundary between the housing 13 and the radially outer portion of the rear guide element. Alternatively, sealing to the rear of the rear element is also possible. On the front side, an additional sealing element 31 is provided at the boundary between the housing wall 13 and the radially outer edge region of the front lateral contact portion 20 of the ultrasonic horn.

[0074] In this case, a sleeve 40 is further provided between the piezoelectric ring element and the cylindrical outer surface 46 of the rear extension 21. Typically, this sleeve can be a heat-shrinkable sleeve to obtain optimal conditions.

[0075] In this case, the rear extension 21 extends rearward beyond the piezoelectric ring. At this protruding portion, the diameter of the rear extension 21 may increase again, or a ring made of ultrasonic horn material may be attached to the rear portion 24. The corresponding mass can function as a countermast to balance the entire ultrasonic horn in order to obtain optimal resonance conditions.

[0076] In this case, the hollow space of the housing 13 is sealed by a combination of sealing elements 30-32 and 36. Furthermore, to enhance protection, the voids within the housing can also be filled with an inert gas.

[0077] Figure 5 shows another embodiment similar to that shown in Figure 4, except that the rear guide element 26 is omitted. In this case, the mounting tube 29 extends to the small, narrow rear opening 28 of the handgrip, and a sealing element 37 is provided at this end position as well, to ensure the safety of the gap, especially during sterilization and subsequent cooling.

[0078] Another method for addressing sterilization issues is shown in the embodiment in Figure 6. In this case, instead of providing mounting tubes 29 and corresponding sealing elements, ventilation openings 38 are provided in the wall of the housing 13, allowing moisture accumulated or generated during or after cleaning and sterilization to escape, thus preventing corrosion problems. The ventilation openings are preferably designed so that the operator cannot directly contact the internal components, and so as to allow for cleaning of any dirt that may accumulate during operation or use. [Explanation of Symbols]

[0079] 1. Ultrasonic generator 1a Cable between 1 and 2 2 Hand Grips 2a 2 rod-shaped element 2b 2 gripping extension 3 Covering 4 Sonotoro 5 Insertion Devices 6 Reamers 7. Improved sleeves, stabilization sleeves 8 guide pins 9. Cleaning Devices 10 Torque Key 11 Foot pedals 12. Ultrasonic Horn 13 Housing 14 Radial gap between 12 and 13 15 12 vibration damping mounting parts in 13 16 circular piezoelectric elements 17. Connection part to 4, front extension part including screw 18 Connection to 12, rear cavity including internal thread 19 13 Front opening Front lateral contact area between 20 12 and 4 21 Rear extension of 12 22 12 main part 23 Shoulder portion between 22 and 21, reduced diameter portion of 16 24 12 counter spaces 25 12 Rear insertion funnel section 26 Rear guide element 27 13 26 vibration damping mounting parts 28 13 Rear opening 29 Mounting pipe 30 Seal between 12 and 29 31 Seal between 12 and 13 / 19 32 Seal between 26 and 13 / 28 33 26 Rear insertion funnel section 34 29 Front opening 35 29 Rear opening 36 Seal between 29 and 26 Seal between 37 29 and 13 / 28 38 Ventilation openings Through opening passing through 39 26 40 Sleeve between 16 and 24, heat shrink sleeve Outer diameter of 41 4 42 4 central void 8 cannulations for 43 52 Through openings for 8 and 52 in 44 26 45 12 cannulations 46 21 Cylindrical outer surface 47 16 cylindrical inner surface 48 13 cylindrical wall section 52 K wire 53 Vertebral elements 54 Stabilizing sleeve that penetrates the surrounding cavity and the porous portion of 53 55 Implants, Screws 56 depression

Claims

1. A handgrip (2) for improving depressions (56), particularly depressions in porous perforated material having cavities created by the depressions (56), and for generating or combining mechanical energy, comprising a cylindrical collar (4) having a cylindrical jacket surface having an outer diameter and a central cavity (42) for receiving a guide pin (8), The guide pin (8) is movably housed within the central cavity (42) such that when mechanical energy is applied, the cylindrical collar (4) can move relative to the guide pin (8) toward the bottom of the recess (56), while liquefying the material of the improved sleeve (7), which is made of a material that can be liquefied by mechanical energy, and displacing it laterally and / or longitudinally, and the material of the improved sleeve (7) surrounds the guide pin (8). The guide pin (8) preferably has an axial central through bore in the form of a cannulation (43) for receiving a wire (52), wherein the wire (52) is inserted into the cannulation (43) of the guide pin (8) at least before mechanical energy is applied. The handgrip (2) is cannular along its entire axial length to precisely position it within the hole to be improved, allowing the guide pin (8) to be inserted and completely passed through, and also allowing the wire (52), if present, to be inserted into the cannulation (43) of the guide pin (8) and completely passed through. The handgrip comprises a housing (13) to which an ultrasonic horn (12) is attached. The ultrasonic horn (12) is cannular in shape along its entire axial length, allowing the guide pin (8) to be inserted and completely passed through it, and if present, the wire (52) can be inserted into the cannulation (43) of the guide pin (8) and completely passed through it. The ultrasonic horn (12) is provided with at least one annular piezoelectric element (16) for generating ultrasonic vibrations over at least a portion of its axial length. Hand grip.

2. The hand grip according to claim 1, wherein two or more annular piezoelectric elements (16) for generating ultrasonic vibrations are provided, the annular piezoelectric elements (16) are located adjacent to each other in the axial direction, and preferably at least two or at least three or exactly two or exactly three, preferably identical annular piezoelectric elements (16) are arranged in the axial direction.

3. The hand grip according to claim 1 or 2, wherein at least one of the annular ultrasonic vibration generating piezoelectric elements (16) is located behind the main portion (22) of the ultrasonic horn (12), surrounded by or surrounding a rear extension (21) of the ultrasonic horn (12) having a smaller diameter than the main portion (22), and preferably directly adjacent to a shoulder portion (23) that extends radially between the main portion (22) and the rear extension (21), and preferably at least one sleeve is provided between the cylindrical outer surface (46) of the rear extension and the cylindrical inner surface (47) of the annular ultrasonic vibration generating piezoelectric element (16), the sleeve preferably contains or is made of a polymer damping material, and preferably is a heat-shrinkable sleeve.

4. The hand grip according to any one of claims 1 to 3, wherein the ultrasonic horn (12) is made of titanium or a titanium alloy and preferably comprises a front extension (17) having an external thread or bayonet lock, the front extension (17) preferably penetrates at least partially beyond the front section of the housing (13) and functions as a connector for attaching a cylindrical collar (4) having a corresponding rear recess (18) having an internal thread or bayonet lock.

5. The hand grip according to any one of claims 1 to 4, wherein the ultrasonic horn (12) is attached to the hand grip (2) in a vibration damping manner, preferably with respect to an axial or radial gap (14) between the ultrasonic horn (12) and a preferably cylindrical wall portion (48) of the housing (13), and at least one vibration damping mounting element (15), preferably arranged along the axial direction of the hand grip (2), is provided within the axial or radial gap (14), and preferably the vibration damping mounting element (15) is selected as an elastic O-ring (15).

6. The hand grip according to any one of claims 1 to 5, wherein in the rear portion of the hand grip (2), the housing (13) or a part thereof is provided with a rear guide element (26) having a through opening (44) for the guide pin (8) and the wire (52), preferably the rear guide element (26) is made of the same material as the ultrasonic horn, or is part of the housing, and / or is attached by at least one vibration damping mounting element (27) in the housing (13).

7. A hand grip according to any one of claims 1 to 6, wherein a sealing element (31) is provided between the housing (13) and the ultrasonic horn (12), particularly at the boundary between the front opening (19) of the housing (13) and the front lateral contact portion (20) or the front contact portion (20) or its edge, and preferably, if a rear guide element (26) is present, a sealing element (32) is provided at the boundary between the rear opening (28) of the housing (13) and the rear or radial surface of the rear guide element (26).

8. A mounting tube (29) is provided on the cannulation (45) of the ultrasonic horn, the mounting tube (29) preferably extends between the tip of the ultrasonic horn (12) and the rear opening of the housing (28) and / or the rear opening of such rear guide element (26), if such rear guide element (26) is present, and preferably the mounting tube (29) is made of a polymer material, preferably a partially or fully halogenated polymer material, most preferably a PTFE material, the hand grip according to any one of claims 1 to 7.

9. The mounting tube (29) is sealed by a circumferential sealing element (30) at least at the front opening of the ultrasonic horn (12), and the mounting tube (29) is essentially flush with the front extension (17) of the ultrasonic horn (12), and / or Preferably, the mounting tube (29) is sealed against the housing (13) or, if present, against the rear guide element (26) by circumferential sealing elements (36, 37), or the mounting tube (29) is sealed by crimping its end portion in a sealed manner, according to claim 8.

10. The housing (13) is provided with at least one ventilation opening (38), or The hand grip according to any one of claims 1 to 9, wherein the housing (13) is sealed and its cavity is filled with an inert gas, particularly nitrogen gas.

11. The hand grip according to any one of claims 1 to 10, comprising a rod-shaped element (2a) essentially coaxial with the cylindrical collar (4), and a gripping extension (2b) branching from the rod-shaped element (2a) at an angle preferably in the range of 90° to 60° for the user to hold, wherein the gripping extension (2b) is preferably provided with a manual actuation element for controlling the energy transmitted by the cylindrical collar (4).

12. The guide pin (8) is made from a synthetic polymer material, preferably a thermoplastic material, particularly PTFE and / or PFA, and / or the guide pin (8) has an outer diameter in the range of 1.2 mm to 10 mm or 1.5 mm to 10 mm, preferably 2 mm to 4 mm, particularly preferably 2.5 mm to 3.5 mm, and the diameter of the cannulation (43) is in the range of 0.5 mm to 3 mm, preferably 1 mm to 2 mm, particularly preferably 1.3 mm to 1.75 mm, and / or The outer diameter of the collar (4) is in the range of 1 mm to 80 mm, preferably in the range of 2 mm to 10 mm, and the outer diameter of the guide pin (8) is 0.1 mm to 20 mm smaller than that, preferably 0.1 mm to 2 mm or 0.5 mm to 1 mm smaller, and the improved sleeve has a thickness such that its outer diameter is the same as the outer diameter of the collar (4), or is larger or smaller than the outer diameter of the collar (4) by a range not exceeding 0.2 mm, 1.5 mm, or 0.01 mm, and the improved sleeve has a wall thickness in at least some sections, preferably in the range of 0.1 mm to 2 mm or 0.1 mm to 1 mm, preferably in the range of 0.2 mm to 0.6 mm. The hand grip according to any one of claims 1 to 11.

13. The handgrip generates mechanical energy in the form of vibrational energy and / or oscillation energy having a frequency in the range of 1 kHz to 10 GHz, preferably in the form of ultrasonic oscillation in the frequency range of 10 kHz to 100 MHz or 20 kHz to 150 kHz, particularly preferably in the form of ultrasonic oscillation in the range of 20 kHz to 70 kHz or 20 kHz to 40 kHz, and the mechanical energy is transmitted to the collar (4) and, by extension, the improved sleeve (7) in the longitudinal direction, transverse direction, rotational direction, or a combination or linear combination of these directions, preferably substantially exclusively in the longitudinal direction, and / or The wire (52) is preferably a sterilized stainless steel pin, preferably having a rounded or sharpened tip at least at one end, preferably having a circular cross-section along its entire length, and having a diameter in the range of 0.4 mm to 3 mm, preferably 0.9 mm to 1.9 mm, and more preferably 1.25 mm to 1.7 mm. The hand grip according to any one of claims 1 to 12.

14. A method for operating a handgrip according to any one of claims 1 to 13, The wire (52) is centrally inserted into the recess (56) and pushed to the bottom of the recess (56). If necessary, the inner surface of the recess (56) is prepared for improvement by using a reamer (6) having a central cannulation, the cannulation being pushed along the wire (52) for controlled insertion of the reamer (6) into the recess (56), the reamer (6) being positioned / advancing axially within the recess (56) and rotated until the desired preparation of the recess (56) is complete, thereafter the reamer (6) is withdrawn while maintaining the wire (52) in place. If necessary, the insertion device (5) having an improved sleeve (7) attached to the distal tip portion of the insertion device (5) and having a central cannulation, the insertion device (5) having the improved sleeve (7) is pressed by the cannulation on the wire (52) for controlled insertion of the insertion device (5) having the improved sleeve (7) into the recess (56), positioning the improved sleeve (7) in the bottom region of the recess (56), and then the insertion device (5) is removed while maintaining the improved sleeve (7) in the recess (56) and the wire (52) in place. The guide pin (8) is provided for controlled insertion of the guide pin (8), and preferably, when an insertion device (5) is used, for insertion of the distal portion of the guide pin (8) into the positioned improvement sleeve (7) in the recess (56), or for insertion of the improvement sleeve (7) together with or after the guide pin (8), by the cannulation (35) of the guide pin (8) on the wire (52) so that the guide pin (8) contacts the bottom of the recess (56) and / or a guide pin positioned at the bottom of the recess (56). Pressed until it engages with the suppressor, where the recess (56) has an inner diameter substantially corresponding to the outer diameters of the collar (4) and the improvement sleeve (7), and thereafter, using a protective sleeve to protect the surrounding soft tissue if necessary, the liquefied material is introduced into the cavities adjacent to the recess (56), particularly the lateral cavities, by the simultaneous liquefaction of the improvement sleeve (7) by applied mechanical energy, preferably by applied ultrasonic waves, and by the pressing of the distal end of the collar (4) into the recess (56) by the application of manual force to the handgrip (2). A method characterized by the following features.

15. It is a non-surgical method, and / or the depression (56) is a depression in at least partially porous technical material, including wood or wood-like material, or foam material, in particular polymer foam, composite foam, and / or metal foam, or in a porous bone portion of at least partially dead or living human or dead or living animal, in particular the jawbone or vertebral bone, the depression is preferably at least partially produced by pre-drilling. The method according to claim 14.

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