DEVICES AND METHODS FOR MINIMALLY INVASIVE IMMEDIATE IMPLANT STABILIZATION

Abstract

A system for the amelioration of a recess (56) is disclosed, particularly of a recess in a porous, perforate material having cavities freed by the recess, said system comprising an element (2) for generating or coupling in mechanical energy, and a cylindrical collar (4, 40) having a central recess (44,45) for receiving a guide pin (8), wherein the guide pin (8), having a cannulation (35), is provided to be inserted substantially as far as the bottom of the recess (56) under positioning using a wire (52) before mechanical energy is applied, wherein the guide pin (8), in the area of the end thereof directed toward the bottom of the recess (56), is surrounded by an amelioration sleeve (7), wherein the external cylindrical jacket surface of the amelioration sleeve (7) has substantially the same external diameter as the collar (4, 40), and wherein the guide pin (8) is received movably in the central recess (44,45) such that, when mechanical energy is applied, the collar (4,40) can be moved relative to the guide pin (8) in the direction toward the bottom of the recess (8) while liquefying and laterally and/or longitudinally displacing the material of the amelioration sleeve (7).

Claims

1. A system for the amelioration of a recess (56), particularly of a recess in a porous, perforate material having cavities freed by the recess, said system comprising an element (2) for generating or coupling in mechanical energy, and a cylindrical collar (4, 40) with a cylindrical jacket surface having an external diameter and having a central recess (44,45) for receiving a guide pin (8), wherein the guide pin (8), having an axial central through bore in the form of a cannulation (35), is provided to be inserted substantially as far as the bottom of the recess (56) under positioning using a wire (52) inserted into said cannulation (35) of the guide pin (8), before mechanical energy is applied, wherein the guide pin (8), in the area of the end thereof directed toward the bottom of the recess (56), is surrounded by an amelioration sleeve (7) made from a material that can be liquefied by mechanical energy, wherein the external cylindrical jacket surface of the amelioration sleeve (7) has substantially the same external diameter as the collar (4, 40), and wherein the guide pin (8) is received movably in the central recess (44,45) such that, when mechanical energy is applied, the collar (4,40) can be moved relative to the guide pin (8) in the direction toward the bottom of the recess (8) while liquefying and laterally and/or longitudinally displacing the material of the amelioration sleeve (7) wherein the cylindrical collar (4,40) has a circular cylindrical jacket surface, and the amelioration sleeve (7) has a circular cylindrical jacket surface, and wherein the external diameter of the collar (4,40) and of the amelioration sleeve (7) are substantially the same as the internal diameter of the recess (56) to be ameliorated, and wherein the collar (4,40), at its distal end, has a circumferential distal edge (43) tapering toward said distal end, wherein this distal edge (43) is either straight, and therefore conical, or curved, in particular concave or convex, or has a radially stepped design at the distal end, wherein the circumferential distal edge (43) is arranged at the step transition, and wherein the amelioration sleeve (7) is a simple hollow cylinder (7).

2. System according to claim 1, wherein the guide pin (8), at at least one end thereof, preferably at both ends, has a circumferential edge (36, 38) which is tapering towards the respective end of the guide pin (8), wherein preferably the inclination angle of the tapering surface with respect to the main axes of the guide pin (8) at the circumferential edge (36, 38) is in the range of 20-60°, more preferably in the range of 30-45°.

3. System according to any of the preceding claims, wherein the guide pin (8) is made of synthetic polymer material, preferably of a thermoplastic material, in particular PTFE and/or PFA, and/or wherein the guide pin (8) 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 (35) 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.

4. System according to any of the preceding claims, wherein it further comprises an insertion device (5) for inserting the amelioration sleeve (7) into said recess (56), wherein said insertion device (5) has an axial central through bore in the form of a insertion device cannulation (25,26), and is provided to be inserted substantially as far as the bottom of the recess (56) under positioning using a wire (52) inserted into said insertion device cannulation (25, 26) before said guide pin (8) is to be inserted using the same wire (52), and wherein preferably the diameter of the cannulation (35) of the guide pin (8) is the same as the diameter of the insertion device cannulation (25, 26), wherein preferably at its proximal end the insertion device (5) is provided with a handle (23) and/or at its distal end the insertion device (5), having a cylindrical outer surface at its distal end in as far as inserted into said recess (56), is provided with a narrowed portion (29) with a reduced outer diameter and a step transition (30) towards the proximal end so as to provide a formfitting structure for temporary holding of the amelioration sleeve for insertion, wherein further preferably the cylindrical narrowed portion (29) as well as at least a portion of the cylindrical outer surface (28) of an extension portion (24) of the insertion device (5) adjacent to the narrowed portion (29) is flattened (57, 58), preferably at opposing sides.

5. System according to any of the preceding claims, wherein it further comprises a reamer (6) for smoothing the inner surface of the recess (56) prior to amelioration thereof, wherein said reamer (6) has an axial central through bore in the form of a reamer cannulation (17), and is provided to be inserted substantially as far as the bottom of the recess (56) under positioning using a wire (52) inserted into said reamer cannulation (17) before an insertion device (5) for the insertion of the amelioration sleeve (7) and/or said guide pin (8) is/are to be inserted using the same wire (52), and wherein preferably the diameter of the cannulation (35) of the guide pin (8) is the same as the diameter of the reamer cannulation (17) and, in case of using an insertion device (5) the diameter of the insertion device cannulation (25, 26).

6. The system according to any of the preceding claims, characterized in that the central recess (44, 45) is a circular cylindrical recess which is arranged coaxially with respect to the cylindrical jacket surface, in that the amelioration sleeve (7) has a circular cylindrical recess for receiving the guide pin (8), and in that the guide pin (8) has a circular cylindrical outer surface, wherein the internal diameters of said recesses are substantially the same as the external diameter of the guide pin (8), or in case of the circular cylindrical recess of the amelioration sleeve (7) this circular cylindrical recess is larger than the external diameter of the guide pin (8) to adapt for the amount of material to be liquefied, and/or wherein the guide pin (8) can be pushed into the collar (4,40) at most as far as an abutment position, wherein the guide pin (8), in this abutment position, ends at most flush with the distal end of the collar (4,40), but preferably protrudes beyond this end, wherein the protruding length in the abutment position is preferably at least 1-10 mm, preferably 2-3 mm.

7. The system according to any of the preceding claims, wherein the external diameter of the collar (4, 40) is in the range of 1-80 mm, preferably in the range of 2-10 mm, and in that the external diameter of the guide pin (8) is 0.1-20 mm less, preferably 0.1-2 mm or 0.5-1 mm less, and in that the amelioration sleeve has a thickness such that the external diameter thereof is the same as the external diameter of the collar (4,40), 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.

8. The system as claimed in one of the preceding claims, characterized in that the element (2) 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 30-70 or 50-70 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 (4, 40) and/or guide pin (8) and thus indirectly to the amelioration sleeve (7), wherein the collar (4, 40) is preferably secured on or part of the sonotrode, and the guide pin (8) can be moved therein, or the guide pin (8) is secured on the sonotrode, and the collar (4, 40) can be moved, or collar (4, 40) and guide pin (8) are secured on a sonotrode or coupled thereto.

9. The system as claimed in one of the preceding claims, characterized in that the amelioration sleeve (7) is made from a material that can be liquefied by the mechanical energy, particularly by oscillation energy, and that is selected from the following group: thermoplastic biocompatible polymers such as polyolefins selected from PP, LDPE, HDPE, UHMWPE, polyoxymethylene, polyaryl ether ketones, such as PAEK, PEEK, PEKK, polycarbonates, polyacrylates, such as PMMA, polyamides, polyesters, such as PET, PBT, polysulfones and polyether sulfones, such as PSU, PES and/or biodegradable or resorbable polymers, such as poly(L-lactide) (PLLA), poly(D,L-lactide) (PDLLA) and/or stereocopolymers thereof with a variable ratio of the L and D,L part, polyglycolides (PGA) and/or copolymers, such as polyglycolide-co-trimethylene carbonate (PGA-co-TMC), poly(D,L-lactide-co-glycolide) (PDLLA-co-PGA) and poly(L-lactide-co-glycolide) (PLLA-co-PGA), poly(e-caprolactone), polydioxanones, trimethylene carbonates (TMC), polyorthoesters (POE) and other polyanhydrides, resorbable polymers which are produced from natural raw materials, such as modified polysaccharides (cellulose, chitin, dextran, starch), or a combination or a mixture of these materials, wherein one or more pharmaceutical active substances can preferably also be provided in this material or this material mixture or applied as a layer on this material, wherein these pharmaceutical active substances are preferably released in a controlled manner.

10. The system according to any of the preceding claims, characterized in that it further comprises a handgrip (2) for mounting of a sonotrode or including a sonotrode (4), wherein preferably the handgrip (2) is cannulated through its full axial length to allow for the insertion of a wire (52) for accurate positioning in the hole to be ameliorated, and/or wherein further preferably the handgrip (2) has, mounted thereon in an only axially movable manner, attached a tubular protection sleeve, preferably made of metal or suitable plastic material, surrounding at least partially the sonotrode (4) and preventing contacting of the sonotrode (4) with surrounding soft tissue located above the bone with the hole to be ameliorated, and/or wherein the handgrip further comprises means to activate the ultrasonic energy generator for activation of the sonotrode (4), and/or in that the system further comprises a wire (52), preferably in the form of a preferably sterilized stainless steel pin, preferably having a sharpened tip at least at one end, with preferably circular cross-section over its 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.

11. Guide pin (8) for use in a system according to any of the preceding claims, wherein the guide pin (8), preferably at at least one end thereof, preferably at both ends, has a circumferential edge (36, 38) which is tapering towards the respective end of the guide pin (8), wherein preferably the inclination angle of the tapering surface with respect to the main axes of the guide pin (8) at the circumferential edge (36, 38) is in the range of 20-60°, more preferably in the range of 30-45°, and/or preferably wherein the guide pin (8) is made of synthetic polymer material, preferably of a thermoplastic material, in particular PTFE and/or PFA, and/or wherein the guide pin (8) 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 (35) is in the range of 0.5-3 mm, preferably in the range of 1-2.5 mm, particularly preferably in the range of 1.3-2.0 mm.

12. A sterile package with a guide pin (8) as claimed in claim 11.

13. A method for operating a system as claimed in one of claims 1-10, characterized in that a wire (52) is centrally inserted into a recess (56) and pushed into the very bottom thereof, if needed the inner surface of the recess (56) is prepared for amelioration by using a reamer (6) with a central cannulation (17), which cannulation (17) is pushed over said wire (52) for controlled insertion of the reamer (6) into the recess (56), the reamer (6) being rotated when positioned in the recess (56) until the desired preparation of the recess (56) is terminated, and subsequently the reamer (6) is taken out while keeping the wire (52) in place, if needed an insertion device (5) having an amelioration sleeve (7) mounted at the distal tip portion thereof and having a central cannulation (25, 26) is pushed with said cannulation (25, 26) over said wire (52) for controlled insertion of the insertion device (5) with the amelioration sleeve (7) into the recess (56) and positioning the amelioration sleeve (7) in the bottom region of the recess (56), and subsequently taking out the insertion device (5) while keeping the amelioration sleeve (7) in the recess (56) and keeping the wire (52) in place, the guide pin (8) is pushed with its cannulation (35) over said wire (52) for controlled insertion of the guide pin (8) and for insertion of the distal portion thereof into the positioned amelioration sleeve (7) in the recess (56) if an insertion device (5) has been used, or for inserting the amelioration sleeve (7) together with the guide pin (8), wherein the recess (56) has an internal diameter corresponding substantially to the external diameter of collar (4, 40) and amelioration sleeve (7), until the guide pin (8) abuts against the bottom of the recess (56) and/or engages in a guide taper arranged at the bottom of the recess (56), and then, with simultaneous liquefying of the amelioration sleeve (7) by applied mechanical energy, preferably by applied ultrasound, if needed using a protection sleeve for protecting surrounding soft tissue, and with pushing of the distal end of the collar (4, 40) into the recess (56), liquefied material is introduced into cavities, particularly lateral cavities, adjoining the recess (56).

14. A method according to claim 13, wherein the method is a non-surgical method.

15. A method according to any of the preceding claims 13 and 14, wherein the recess (56) is 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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Preferred embodiments of the invention and are described in the following with reference to the drawings, which are for the purpose of illustrating the present preferred embodiments of the invention and not for the purpose of limiting the same. In the drawings,

[0068] FIG. 1 shows the kit of parts;

[0069] FIGS. 2a)-2c) show in 2a) shows a side view of the reamer, in 2b) a perspective view and in 2c) a detailed view of the tip portion of the reamer,

[0070] FIGS. 3a)-3f) show in 3a) a perspective view of the insertion device, in 3b) an axial cut thereof and in 3c) a front view, in 3d) the details of an axial cut through the tip portion and in 3e) the details of an axial cut through the transition portion of the insertion device, and in 3f) a modified tip design of the insertion device;

[0071] FIG. 4 shows a side view of the guiding pin;

[0072] FIGS. 5a)-5c show in 5a) an axial cut through the sonotrode, in 5b) a front view of the sonotrode, in 5c) the details of an axial cut through the tip portion of the sonotrode;

[0073] FIGS. 6a)-6b) show in 6a) an axial view on the stabilization sleeve and in 6b) an axial cut thereof;

[0074] FIGS. 7a)-71) show the individual steps when using these elements for amelioration of an opening;

[0075] FIG. 8 shows another a modified tip design of the insertion device; and

[0076] FIGS. 9a)-9c) FIG. 9a show how it is possible to provide markings for the insertion depth of the sonotrode, FIG. 9b) shows how it is possible to provide markings for the insertion depth of the reamer and FIG. 9c) shows how it is possible to provide markings for the insertion depth of the insertion device in conjunction with a protective sleeve.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0077] FIG. 1 shows the entire immediate stabilization system with all components required for the immediate stabilization system augmentation process. The ultrasonic (US) generator 1. the handgrip 2 with the covering ring 3, the sonotrode 4 and the ISS sleeve 4 together with the guide pin 8 represent the core-components of the system. The US generator 1 supplies the handgrip 2 (converter) with electrical power, which 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 polylactide ISS sleeve 7 with the power/energy necessary for melting the material and moulding it into the adjacent trabecular bone structure. Pre-clinical test have shown that this leads to an enhanced mechanical stability of the surrounding bone structure.

[0078] Furthermore the system may include an insertion device 5, a reamer 6, the cleaning device 9 and a torque key 10. Furthermore and advantageously 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 transfer to the handgrip 2 and transmitted to the sonotrode 4.

[0079] In FIGS. 2a)-2c) a reamer 6 for use in such a system is shown. The reamer comprises handgrip 12 and the actual extension portion 13. which at the tip of it comprises a threaded portion 14. The very tip 15 of the reamer 6 is illustrated in detail in FIG. 2c), the reamer is shown in a side view in FIG. 2a), and in a perspective view in FIG. 2b). Importantly, the reamer 6 comprises a fully penetrating cannulation 17, so this cannulation 17 also penetrates the handgrip 12 and forms the handgrip opening 16 of the cannulation 17. At the tip of the reamer 6 it is forming a tip opening 18 of the cannulation 17. The tip portion has a stepped design in that it comprises a distal front edge 19 adjacent to the tip opening 18, and then a cylindrical transition portion 21 followed by a proximal step portion 20 of the tip. Using this reamer for preparation of the recess 56 leads to a stepped shape at the bottom of the recess simplifying insertion and also improving positioning of the guide pin. FIGS. 3a)-3f) shows the insertion device 5 in various different representations. As one can see the insertion device also comprises handgrip 23 which, by a transition portion 27. is attached to an extension portion 24 which is a cylindrical tubular structure which also has a cannulation. In the extension 24 there is a distal narrow portion of the cannulation 26, and in the handgrip 23 there is a proximal wider portion of the cannulation 25. The cannulation 26 at the tip of the insertion device (see details in FIG. 3d) forms a tip opening 32, and the tip portion of the extension 24 in this region is provided with a front surface and chamfered edges. Importantly, in the tip region there is provided a reduced outer diameter tip portion 29 which is used as a seat for the amelioration sleeve. The outer diameter of this reduced outer diameter tip portion 29 essentially corresponds to the inner diameter of the amelioration sleeve which is used. This portion 29 towards the proximal end of the insertion device ends at the step 30 between the cylindrical outer surface 28 of the extension 24 and the portion 29. This step 30 acts as a stop for an amelioration sleeve shifted onto the tip portion of the insertion device. Preferably the height of the step 30 is somewhat less than the wall thickness of the amelioration sleeve, so that when drawing the insertion device out of the recess after positioning, the amelioration sleeve remains in the recess and is not drawn out together with the insertion device.

[0080] FIG. 3f) shows a slightly different particularly advantageous tip design for such an insertion device 5. In this particular case, the tip is represented together with the amelioration sleeve 7 mounted on the reduced outer diameter tip portion 29. This reduced outer diameter tip portion 29 is flattened in region 57/58 on both opposing sides. This flattening extends not only in the reduced outer diameter tip portion 29 but the flattening extends partially into the cylindrical outer surface 28 behind the reduced outer diameter tip portion 29. The advantages of this tip design are as follows: the tip design leads to a better release of the amelioration sleeve 7, because the trabecular bone structure “catches” the sleeve 7 at the surface behind the sleeve 7. As a matter of fact, due to the window 60 formed in the region 58 behind the sleeve 7 the rear edge 59 of the sleeve 7 is exposed and after insertion of the insertion tool with the sleeve into the whole to be ameliorated this edge 59 hooks with the hole to be ameliorated and upon withdrawal of the insertion tool automatically the sleeve 7 remains in the hole in the desired position. Furthermore, by bracing the sleeve 7 in a slightly oval shape, one can increase the manufacturing tolerance of the insertion tool tip and get a higher “clamping” force by means of an increased diameter.

[0081] FIG. 4 shows the guide pin for use in such a system. The guide pin 8 is a cylindrical structure of a polymer material that has a central cannulation 35 that is coaxial with the outer surface of the cylinder. Preferably at both ends the guide pin is provided with chamfered portions 38 and 36, the angles of which relative to the main axes may be the same or different. Furthermore the guide pin has a tip opening 37 at I and a backside opening 39 at the other end.

[0082] FIGS. 5a)-5c) show a sonotrode 4 for use in such a system. The sonotrode comprises a holding portion 41 which preferably as, in diameter, flattened portions 46 and which has a central opening. Furthermore there is an extension portion 40 with and enclosing a cylindrical inner opening 44. In the tip portion this cylindrical opening 44 as a smaller inner diameter than in the proximal portion 45. The tip portion of the sonotrode has a chamfered front edge 43 surrounding the tip opening 47, and the angle between the main axes of the sonotrode for and this chamfered surface is 45°.

[0083] FIGS. 6a) and 6b) show an amelioration sleeve 7 for use in such a system. The amelioration sleeve is made of a polylactide material which can be liquefied by ultrasonic energy and which is bio resorbable. It has a cylindrical inner surface 50 the inner diameter of which corresponds to the outer diameter of the guide pin 8. A possible dimensioning of these two devices is that the inner diameter of the amelioration sleeve is 3.65.sup.−0.05/−0.00 mm and the outer diameter of the guiding pin is 3.sup.−0.02/−0.05 mm. So there is a play between the outer diameter of the guiding pin and the inner diameter of the amelioration sleeve. This is desired if only a small amount of material shall be introduced into the porous wall of the hole to be ameliorated. In this case the wall thickness of the amelioration sleeve is 0.3 mm.

[0084] However if more material is to be used for ameliorating the hole, an amelioration sleeve with the same outer diameter but with an inner diameter of e.g. 3.35 mm can be used amounting to about 50% more material. If even more material shall be available an amelioration sleeve with the same outer diameter and an inner parameter of 3.1 mm can also be used, amounting to almost twice the material of the slim sleeve, and all these amelioration sleeves can be handled with the same sonotrode and guiding pin, which is a huge advantage as it allows for adaptation of the amount of material for amelioration by simply choosing adapted amelioration sleeves without having to change the hardware for inserting the amelioration. The cylindrical outer surface 49 corresponds with its outer diameter typically to the outer diameter of the extension portion 40 of the sonotrode 4 or is somewhat larger and the outer diameter of the extension portion of the sonotrode. The wall portion 51 typically has a thickness of 0.2-0.6, or 0.2-0.4 mm preferably of 0.3 mm.

[0085] In the following it shall be illustrated how the proposed method for minimally invasive amelioration can be used in detail in the context of FIGS. 7a)-7l).

[0086] As illustrated in FIG. 7a), 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.

[0087] To enable a guided operation procedure, a K-wire (Kirschner Wire) 52 is introduced into the existing channel 56.

[0088] The method then comprises a step of implant bed preparation as illustrated in FIG. 7b). 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.

[0089] The final depth can be recognized by the depth scale which is provided on the shank of the reamer.

[0090] The next step as illustrated in FIG. 7 c) 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.

[0091] Then, as illustrated in FIG. 7 d), showing the ISS sleeve insertion, the ISS sleeve 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.

[0092] 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).

[0093] In the next step, as illustrated in FIG. 7 e), showing the insertion of the guiding pin, the ISS guiding 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.

[0094] The next step is the step of temporary removal of the K-wire, as illustrated in FIG. 7 f). In order to perform the ISS melting process, the K-wire needs to be removed temporary.

[0095] In the next step as illustrated in FIG. 7 g) showing settling the sonotrode oscillation, before starting the US oscillation, the sonotrode 4 is placed slightly over the ISS sleeve 7 inside the implant bed. At the moment of activation, the sonotrode 4 should be free from any fixation or other external forces for ensuring a successful settling of the sonotrode ultrasound oscillation.

[0096] In the next step as illustrated in FIG. 7 h) of the melting of the ISS sleeve, the ultrasound energy is activated by operating the foot pedal. Simultaneously, 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 is operated but typically not longer than 5 seconds. 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.

[0097] In the next step of removing the sonotrode as illustrated in FIG. 7 i) approximately 5 seconds after the ultrasound energy was deactivated again, the molten polymer is re-solidified. By slightly turning the handgrip, the sonotrode 4 will be detached from the molten ISS sleeve and the sonotrode 4 can be easily removed from the implant bed.

[0098] The next step is a step of re-insertion of the K-wire as illustrated in FIG. 7 j). After the ISS melting process has successfully been completed, the K-wire is re-positioned through the remaining guiding pin 8. Thereafter, the guiding pin 8 is removed from the implant bed via the inserted K-wire 52.

[0099] Then follows the step of pedicle screw implantation as shown in FIG. 7 k). The pedicle screw 55 implantation can now be done, following the usual standard surgical procedure for the corresponding implant system.

[0100] FIG. 7 l) shows the finally augmented pedicle screw. After the K-wire has been removed the implantation including the ISS pedicle screw augmentation is completed.

[0101] In FIG. 8 another possible design of the tip portion of the insertion device is shown. As in FIG. 3f), the tip is represented together with the amelioration sleeve 7 mounted on the reduced outer diameter tip portion 29. This reduced outer diameter tip portion 29 is flattened in region 57/58 on both opposing sides. This flattening extends not only in the reduced outer diameter tip portion 29 but the flattening extends partially into the cylindrical outer surface 28 behind the reduced outer diameter tip portion 29. In this particular case the flattening 57/58 is carried out such that the width of the remaining portion of the tip is smaller than the inner diameter of the cannulation, which means that on both sides slots 61 are formed, and two arms 62 are given.

[0102] The advantages of this tip design are as follows: the tip design leads to a better release of the amelioration sleeve 7, because the trabecular bone structure “catches” the sleeve 7 at the surface behind the sleeve 7. Again, due to the window 60 formed in the region 58 behind the sleeve 7 the rear edge 59 of the sleeve 7 is exposed and after insertion of the insertion tool with the sleeve into the whole to be ameliorated this edge 59 hooks with the hole to be ameliorated and upon withdrawal of the insertion tool automatically the sleeve 7 remains in the hole in the desired position. Furthermore, by bracing the sleeve 7 in a slightly oval shape, one can increase the manufacturing tolerance of the insertion tool tip and get a higher “clamping” force by means of an increased diameter. In this embodiment the elasticity of both the amelioration sleeve 7 as well as of the two fingers 62 can be used for holding the amelioration sleeve with just the retaining force as required.

[0103] As pointed out above, it can be advantageous to provide for insertion depth markings on the individual tools. In FIGS. 9a)-9c) this is illustrated for the sonotrode in 9a), for the reamer in 9b) and for the insertion device in 9c). Also illustrated in this representation is a protective sleeve 63 which can be used to protect the surrounding body portions or tissue portions. This protective sleeve 63 comprises three difference portions, a front portion 64, an intermediate portion 65 and a backside portion 66. These portions have an increasing inner and outer diameter and are adapted to the shape in particular of the sonotrode. The front opening 68 has a small diameter and can have a chamfered front edge 69. and the backside opening 67 has a large diameter to take up the handgrip of the sonotrode if fully inserted. Insertion depth markings can either be provided, as illustrated in FIG. 9 a), with respect to the actual insertion into the body portion. This is illustrated as marking 73 giving the actual millimeter values of the insertion depth.

[0104] Another possibility is to provide insertion depth markings relative to the above mentioned protective sleeve 63 rear side edge 74. For the sonotrode this is illustrated by 70, for the reamer by 71 and for the insertion device by 72.

[0105] This simplifies the handling and makes sure that the insertion depth is always measured relative to the same position, since usually the protective sleeve 63 is not removed between the individual steps. For the surgeon it is then easy to use the corresponding appropriate insertion depth by simply choosing one of the insertion depths A-G as given on the corresponding tool.

TABLE-US-00001 LIST OF REFERENCE SIGNS 1 ultrasound generator 2 handgrip 3 covering flog 4 sonotrode 5 insertion device 6 reamer 7 amelioration sleeve, stabilization sleeve 8 guiding pin 9 cleaning device 10 torque key 11 foot pedal 12 handgrip of 6 13 extension portion of 6 14 threaded portion of 6 15 tip of 6 16 handgrip opening of cannulation of 6 17 cannulation of 6 18 tip opening of cannulation of 6 19 distal front edge of tip of 6 20 proximal step portion of tip of 6 21 cylindrical transition portion between 19 and 20 22 transition portion between 12 and 13 23 handgrip of 5 24 extension portion of 5 25 proximal wide portion of cannulation 26 distal narrow portion of cannulation 27 transition portion between 23 and 24 28 cylindrical outer surface of 24 29 reduced outer diameter tip portion of 5 30 step between 28 and 29 31 front surface or 5 32 tip opening of cannulation of 5 33 inner surface of 26 34 handgrip opening of cannulation of 5 35 cannulation of 8 36 chamfered tip portion of 8 37 tip opening of 8 38 chamfered backside portion of 8 39 backside opening of 8 40 extension portion of 4 41 holding portion of 4 42 tip portion of 4 43 chamfered front edge of 4 44 cylindrical inner opening in 4 in tip portion 45 cylindrical inner opening in proximal portion 46 flattened portion of 41 47 tip opening of 4 48 cylindrical inner opening in 7 49 cylindrical outer surface of 7 50 cylindrical inner surface of 7 51 wall portion of 7 52 K-wire 53 vertebra element 54 stabilization sleeve penetrated into porosity of surrounding cavity and 53 55 implant, screw 56 recess 57 flattened portion of 29 58 flattened portion of 28 59 free rear edge of 7 60 window 61 slot formed in 58 62 arm of 29 63 protection sleeve 64 narrow front portion of 63 65 intermediate portion of 63 66 while backside portion of 63 67 wide back opening of 63 68 narrow front opening of 63 69 chamfered portion of 64 70 insertion depth markings on sonotrode 71 insertion depth markings on reamer 72 insertion depth markings on insertion device 73 insertion depth marking relative to tissue/bone 74 rear side edge of 63 D outer diameter of 8 d inner diameter of 8