Device and method for perforating compact bone layer

Abstract

A device and method for perforating a compact bone layer (1) are disclosed. The device comprises a vibration generator for generating mechanical vibrations, in particular ultrasonic vibrations, and an instrument having an elongated shaft (12) and a distal end piece including a perforator (13). The distal end piece is arranged at the distal end of the shaft (12), and the proximal end of the shaft is connected or can be connected to the vibration generator. The perforator (13) has the form of a solid or hollow cylinder. The vibration generator, the shaft (12) and the distal end piece are adapted to each other so that the shaft (12) transmits mechanical vibrations from the vibration generator to the distal end piece when connected to the activated vibration generator, and causes the perforator (13) to vibrate in a direction parallel to its cylindrical axis (B).

Description

Technical Field

[0001] The present invention belongs to the field of medical technology and relates to a device suitable for perforating a compact bone layer, the purpose of which is to be able to transport blood, oxygen and / or living cells from trabecular bone tissue and / or bone marrow located on the inner side of the compact bone layer through the compact bone layer to a repair site on the opposite, outer side of the compact bone layer and thereby enhance tissue repair or tissue regeneration and tissue growth at the repair site. The present invention also relates to a method for perforating a compact bone layer by means of the device. Background Art

[0002] The method in the field of the present invention is known as bone marrow stimulation and comprises microdrilling or microfracture of a compact bone layer between vascularized trabecular bone and / or bone marrow (inside of the compact bone layer) and a tissue layer in need of tissue repair, tissue regeneration or tissue growth to compensate for tissue loss or to enhance tissue (outside of the compact bone layer) due to injury, disease, degeneration or surgery. The compact bone layer to be perforated is in particular a subchondral bone plate in a joint of a human or animal patient. The subchondral bone plate is perforated to enhance the repair of cartilage or the growth of cartilage or appropriate repair tissue (e.g., vascularized granulation tissue or fibrous or fibrocartilaginous tissue), or for the growth of bone tissue or the ossification of cartilaginous tissue in conjunction with an appropriately prepared and stabilized joint (arthrodesis).

[0003] The known microdrilling methods generally consist of producing a plurality of holes through the compact bone layer by means of a rotating drill, the diameter of the holes being, for example, 0.5 mm to 2 mm and, depending on the thickness of the compact bone layer, the depth of the holes being, for example, between about 2 mm and about 10 mm. The known microfracture methods consist of producing openings in the compact bone layer by hammering a generally conical awl into the compact bone layer, the purpose of which is not only to produce openings in the compact bone layer, but in particular to produce microfractures in the bone tissue surrounding the openings, wherein these microfractures are considered to be supplementary perforations of the compact bone layer, the depth of the openings produced by microfractures therefore generally being less than the depth of the openings produced by microdrilling. The advantage of the microdrilling process is that it is easy to remove debris from the holes along the grooves of the drill bit, so that the blood flow through the produced holes is not hindered; its disadvantage is the inevitable generation of thermal stresses on the bone tissue and a mechanical weakening of the compact bone plate that may not be negligible. The advantages of the microfracture process are simple operation, possible smaller opening depth, and basically no debris in the opening that will not block the implementation of the opening; its disadvantages are the compaction of the bone tissue near the opening (destruction and sealing of the trabecular bone structure), the friction between the bone tissue and the tool, and especially the dependence of the achievable microfracture on the quality of the bone tissue on hand, which is usually unknown, which makes the perforation quality and mechanical weakening of the dense bone plate difficult to predict.

[0004] Known instruments for micro-drilling and micro-fractures generally include an axis with a distal portion, which is designed as a drill bit for micro-drilling or as a conical thorn for micro-fractures. Depending on the location and method of micro-drilling or micro-fracture, the use of such instruments is substantially perpendicular to the compact bone layer, i.e., in the same direction as the compact bone layer to be perforated ("direct" mode). This mode is particularly feasible in open joint surgery and similar surgical methods. However, more commonly, especially for minimally invasive joint surgery, the mode is substantially parallel to the compact bone layer to be perforated, i.e., substantially angled relative to the perforation to be produced ("indirect" mode). Instruments suitable for the direct mode may include a substantially straight axis with a coaxially arranged distal portion. Instruments suitable for the indirect mode need to be angled, bent or otherwise adjusted so that the main direction in which the distal portion acts on the compact bone layer is not parallel to the main axis of the axis.

[0005] The following briefly reviewed publications constitute the background technology of the present invention, among which:

[0006] EP1698285 discloses a linear instrument for microfracture of a subchondral bone plate, for example in open joint surgery, the tool comprising a distal portion equipped with a plurality of conical spikes to be impacted into the compact bone layer to create a plurality of openings simultaneously.

[0007] US9237894, WO2014 / 150193 and WO2015 / 179646 disclose angled cone instruments suitable for microfracture of subchondral bone in an indirect manner.

[0008] US9072528 discloses a microfracture instrument comprising curved conical spurs on two opposing lateral sides of its distal end portion, the tool being suitable for indirect approach when driven in oscillatory rotation about its longitudinal axis.

[0009] WO2017 / 073970 discloses a microfracture instrument suitable for arthroscopic surgery (indirect approach), which includes a tubular distal end having a cutting edge suitable for punching a compact bone layer, and the tubular distal end is arranged on a shaft at a certain angle.

[0010] US8409230 discloses various microfracture or microdrilling instruments, all of which include a shaft and a distal piece arranged at an angle to each other, the distal piece not being rigidly connected to the shaft but arranged for combined operation (shaft impacting or rotating the distal piece), wherein the impact may be driven or assisted by ultrasonic energy.

[0011] US2004 / 0127925 describes a percutaneous surgical instrument for dissolving stones or boreholes, comprising an actuator for generating vibrations at ultrasonic frequencies and an angular tube for amplifying the actuator vibrations. A fixed probe is used to dissolve stones, which can be aspirated through the lumen of the fixed probe and the angular tube.

[0012] WO2016 / 057576 discloses an instrument comprising a shaft with a conical thorn for microfracture or an annular curette for scraping bone layers at its distal end, the thorn and curette having the axis of the shaft perpendicular to the thorn and the curette. The proximal end of the shaft is connected to an ultrasonic generator, wherein the generator is adapted to the instrument for longitudinal vibration of the shaft so that the vibration of the thorn or curette is parallel to the axis of the shaft, i.e., substantially parallel to the surface of the compact bone layer during operation. Summary of the invention

[0013] The object of the present invention is to improve the known device and method for perforating compact bone layers briefly described above without further reference to the device and method. With the aid of the device and method according to the invention, it is possible to produce precisely defined openings (e.g. by micro-drilling) having a depth sufficient to achieve the stated purpose, wherein these openings are produced in such a way that the majority of the bone tissue adjacent to the openings is unaffected (substantially without thermal damage, nor compaction of the tissue, nor uncontrolled fractures) and the openings are free of bone debris.

[0014] This object is achieved by the device and method according to the invention. In microfracture treatment, it is important to be able to penetrate the compact subchondral bone layer into the trabecular bone, and not just into the interface, which in the knee means for example that the cannula penetrates 7-8 mm into the bone, the aim being to create a channel into the trabecular bone marrow and keep it open as long as possible, in order to avoid creating a small atraumatic defect. Therefore, the cauterizing effect of the instrument should be minimized (thermal minimization).

[0015] The device according to the present invention comprises a perforating instrument with a shaft and a distal end piece, and it also comprises a vibration generator, preferably an ultrasonic vibration generator, such as a piezoelectric vibration generator. The distal end piece is arranged at the distal end of the shaft, and it comprises a solid (non-hollow) or hollow, substantially cylindrical perforator, which is knocked into or through the compact bone layer during the perforation process. The distal end piece can be composed of the perforator alone, or can include additional elements, such as a coupling element for connecting the perforator to the shaft. The cylindrical axis of the perforator (perforator main axis) is parallel or angled relative to the longitudinal main axis. The proximal end of the shaft is directly or indirectly connected or can be connected to the vibration generator. The vibration generator, the shaft and the distal end piece are adapted to each other so that the main vibration direction of the perforator is oriented parallel to the cylindrical axis of the perforator or parallel to the impact direction, respectively. The device of the present invention may further include a cutting tube as a part of the perforator. The cutting tube can be an integrated component of the perforator, and preferably forms the distal end of the perforator. The cutting tube can also be coupled, in particular rigidly coupled, to the distal end of the perforator. The cutting tube can be coupled to the perforator in such a way that the perforator main axis (B) and the cutting tube main axis coincide or are parallel to each other. Another embodiment of the invention relates to a device, wherein the perforator main axis (B) and the cutting tube main axis form an angle. Preferably, the angle is greater than 90° and less than 180°, and particularly preferably between 120° and 150°. The perforator comprising the cutting tube may have a beveled distal end.

[0016] The term "proximal" as used herein refers to the point of attachment closest to the housing of an ultrasonic surgical instrument or a user of the instrument. The term "distal" as used herein refers to the point of attachment away from the housing of an ultrasonic surgical instrument or a user of the instrument. The distal edge is used to punch or cut bone.

[0017] Using the method according to the invention, the distal surface of the perforator is positioned and maintained against the compact bone layer, and is impacted into the compact bone layer by the action of vibration in the impact direction and possibly forced against the compact bone layer in addition. During impact, the solid perforator will compact the bone tissue from the opening formed at the bottom of the opening, and the hollow perforator will occupy the bone tissue inside it, so as to be taken out from the cylindrical opening formed by the hollow perforator or stored in the perforator and removed together with the perforator. Due to the combination of the cylindrical perforator vibrating in the impact direction, at least the compaction of the lateral bone is prevented and the lateral friction between the perforator and the bone tissue is reduced, the opening formed in this way can be substantially cylindrical, and at least its sidewalls are composed of intact and therefore completely viable bone tissue, and because the bone tissue from the inside of the opening is compacted or "automatically" removed at the bottom of the opening, the opening will not be hindered in any case, without the need for other methods or control steps. In the case where the perforator of the device according to the invention is hollow, it is even possible to use an annular opening (an opening in the form of a cylindrical barrel) in the bone, leaving the bone core there (see Fig.24A and 24B ). This method allows for an increased bleeding surface despite the same number of perforations. However, it is important not to damage the bone core by fracturing or heating. Additionally, the device must be designed to separate the bone core from underlying bone tissue, such as trabecular bone, without damaging the bone core.

[0018] Compared to known microfracture methods, the effect of the method according to the invention can be better predicted with respect to the achievable flow through the perforations and with respect to the mechanical weakening of the compact bone layer, and thus can be better optimized, i.e., an optimal flow with minimal mechanical weakening can be better achieved.

[0019] The preferred diameter of the cylindrical opening produced by the device and method according to the present invention is similar to the opening produced by the known device and method, that is, they are in the range of, for example, 0.5 mm to 2 mm. The preferred diameter of the annular opening produced by the device and method according to the present invention is greater than the diameter of the cylindrical opening, that is, they are in the range of, for example, 1.5 mm to 3 mm, wherein the width of the gap between the bone core and the surrounding bone can be between 0.1 mm and 0.5 mm. The depth of the opening depends on the compact bone layer to be perforated, and for example in the case of a subchondral bone plate for an adult patient's knee, the range is 5 mm to 8 mm. In smaller ankle joints, the opening diameter and depth will be smaller. Preferably, a plurality of openings are produced, wherein for the example of the above-mentioned human knee joint, the distance between adjacent openings is, for example, between 5 mm and 10 mm.

[0020] Preferably, the shaft and the distal part (including the perforator) of the device according to the invention are rigidly connected to each other or form a single piece together, wherein the shaft is designed to transfer the vibration energy from its proximal end to the distal part or the perforator, respectively, as fully as possible. However, the shaft and the distal part can also be designed as two separate or only loosely connected parts, so that the vibrating shaft acts on the distal part or the perforator, respectively, in the manner of a hammer (transmitting only half of the vibration).

[0021] Preferably, the material of the shaft and the perforator of the device according to the invention is a metallic material, such as stainless steel or titanium. Preferably, the connection between the shaft and the vibration generator is detachable, and the instrument including the shaft and the distal piece is disposable.

[0022] The device of the invention is, for example, a handheld device, wherein its handle part houses a vibration generator which is supplied with the necessary energy by means of a battery or by means of a corresponding cable connecting the handheld part to a control and supply unit. The preferred frequency of the vibrations is in the ultrasonic range, preferably in the range of 15 kHz to 40 kHz, or in the range of 20 kHz to 30 kHz, and has an energy sufficient to reach an amplitude in the micrometer range (between 20 micrometers and 120 micrometers or preferably between 60 micrometers and 100 micrometers) at the distal end of the perforator.

[0023] In order to achieve a vibration parallel to the perforator axis, the perforator is rigidly fixed to the shaft and the perforator axis substantially coincides with the shaft axis, the vibration system of the generator, shaft and perforator is designed and activated to vibrate mainly longitudinally in a standing wave and vibrate at the antinode position at the far end of the perforator. If the perforator is rigidly connected to the shaft at a certain angle (the perforator axis or the impact direction is not parallel to the main axis), the same effect can be achieved in the following ways, that is, by designing and activating the vibration system of the vibration generator, shaft and perforator so that it vibrates in a tortuous manner and has an antinode position at the far end of the shaft, or by connecting the distal end piece to the shaft that mainly vibrates longitudinally at the node position of the shaft. The same effect (redirection of vibration direction from parallel to the shaft axis to parallel to the perforator axis) can be achieved by a corresponding design of the distal end piece and its connection to the shaft, such as disclosed in the publication WO2007 / 101362, if the perforator is only loosely fixed or not attached to the shaft, the antinode position should be located at the far end of the shaft.

[0024] The present invention relates to a device wherein the shaft and the distal end piece with the perforator are loosely connected or separated and arranged so that the distal end of the shaft can hammer the perforator. Another embodiment of the present invention relates to a device wherein the main axis and the main axis (B) of the perforator coincide with or are parallel to each other. Another embodiment of the present invention relates to a device wherein the shaft is designed to vibrate in a longitudinal mode.

[0025] When perforating bone, there are several possibilities for handling the removed bone fragments. One possibility is to impact the cut compact bone core into the underlying trabecular bone (see Fig.15 ), the trabecular bone is compacted so that bleeding can be reduced. The fragments can be further aspirated by a special device or a device for perforation. This usually leads to clogging of the suction device. Using the device according to the present invention, the bone can be removed as a bone core or fragment rather than as debris. The bone core can be retained in the distal end of the perforator or cutting tube. Next, the bone core can be removed to the outside and flushed from the operating side with blood, etc., or it can be further aspirated into the space of the shaft or perforator and stored until all perforations are completed and the instrument is removed from the operating side. In this case, the perforator can be a disposable item, which is removed from the device and discarded together with the extracted bone particles after each operation. This makes the cumbersome cleaning of the device redundant. There are no bone fragments that may obstruct the liquid supply or suction device and must be removed.

[0026] One object of the present invention is to provide a device suitable for reducing the obstruction of bone debris within the instrument. Therefore, the present invention is directed to a device wherein the perforator or shaft comprises an opening suitable for storing the removed bone fragments. Another embodiment of the present invention is directed to a device wherein the shaft or perforator comprises a conduit suitable for supplying a liquid to the opening or applying a vacuum to the opening. The use of the liquid supply allows the bone core to be removed from the cutting tube or perforator, while the vacuum is suitable for retaining the bone core within the opening.

[0027] There may be some specific elements inside the perforator or its cutting tube that help to break the bone core after cutting into the compact bone. Such elements may be ribs. The cross-threads of the ribs apply force to the bone core to move it out of the lower layer of bone tissue. Therefore, another aspect of the invention relates to a device in which the perforator or cutting tube includes protruding elements, such as ribs, on its inner surface that are suitable for applying torsional forces to the cut bone. After being removed, the chopped bone core may also be useful. Therefore, the perforator or cutting blade may have a slicing element inside.

[0028] Perforator can have the cross section of for example circle, ellipse or regular or irregular polygon.Solid perforator preferably further comprises the tip of point, i.e. it has the form of awl, wherein the maximum cross section of tip is equal to or slightly larger than the cross section of cylinder.Perforator can also have the form of blade or chisel (narrow elongated cross section) and comprise distal edge.Hollow perforator has the form of bone punch with distal edge.Wherein, the edge of perforator in operation with the narrow contact of bone tissue is preferably sharp or serrated, i.e. comprises the saw-like structure of size in visible or sub-visible range.This is particularly suitable for the distal edge of blade-shaped, chisel-shaped and punch-shaped perforator, but also can be suitable for the side edge of any perforator with polygonal cross section and be suitable for the edge of the pyramid-shaped tip of solid perforator.

[0029] A preferred embodiment of the present invention relates to a device, wherein the perforator or its cutting tube is a hollow cylinder and includes a distal edge. The distal edge is preferably formed as a sharp cutting end suitable for cutting compact bone. Therefore, one embodiment relates to a device according to the present invention, wherein the distal edge ends the inner tapered structure and / or the outer tapered structure of the cylindrical wall. It is further preferred that the distal edge includes a groove on the inside or outside. The groove can represent a depression in the side wall of the perforator or its cutting tube. The width of the groove can be 0.3 mm to 1.5 mm. The surrounding groove can have a constant or constant thickness. Preferably, the transition or groove from the groove to the distal edge is smooth. Therefore, it is preferred that the transition between the surface of the groove and the edge is continuous or curved. If the transition is curved, a limited but stable cutting edge can be formed. Alternatively, there may be a step near the distal edge, wherein the thickness of the side wall increases toward the distal end.

[0030] Sharp cutting edge can also be formed by a separate element attached to the far-end of perforator or its cutting tube. Such element can be a ring made of, for example, ceramic material, the same material as perforator or another alloy, which is clamped in the opening of hollow perforator or hollow cutting tube. Ring can also be welded to perforator or cutting tube after being placed on the far-end of perforator or cutting tube. By cutting into the side wall of perforator or its cutting tube, and forming sharp cutting edge by outward or inward alternating bending or folding formed parts is also possible.

[0031] The device according to the present invention may further include a cannula or guide shaft around the axis of the perforating instrument. Therefore, the transmission of vibration energy through the instrument shaft is as effective as possible, and the friction between the shaft and the cannula is as small as possible. This can be achieved by providing a region with the smallest radial clearance between the instrument and the cannula in the axial position where the most distal node position of the shaft is located. This is achieved by having an axis with an increased cross section at least at the most distal node position, and by a through hole of the guide shaft portion extending from the distal portion to the most distal node position of the sonotrode, the most distal node position of the sonotrode comprising a constant cross section. The axis may also include a portion of a larger cross section at other node positions. In addition, the cannula may have a region of a larger cross section at one or more node positions. It is further preferred that the arrangement including the axis and the cannula has a polymer sliding surface to minimize friction losses. These surfaces can be formed by a polymer ring around the distal end of the axis or perforator or its cutting tube. The polymer ring can be made of PEEK. Alternatively, a polymer sleeve can be attached to the inner surface of the cannula, which can also be made of PEEK. Thus, the area of ​​larger cross section may be formed as a polymer attachment to the cannula or shaft.The area of ​​larger cross section may also have a polymer coating. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Embodiments of the device and method of the present invention are further described in detail with reference to the accompanying drawings, wherein:

[0033] Figure 1 and Figure 2 The invention shows direct and indirect ways of perforating the compact bone layer using the device of the invention;

[0034] Figures 3 to 8 An embodiment showing an arrangement of a shaft and a perforator suitable for the device of the present invention;

[0035] Figures 9 to 13 An embodiment of a perforator suitable for the device of the present invention is shown;

[0036] Fig.14 showing the distal end of the shaft with a plurality of perforators;

[0037] Fig.15 is an axial cross-section through an opening in a compact bone layer formed by a solid perforator;

[0038] Fig.16 The formation of an opening in a compact bone layer by means of a hollow perforator and the removal of bone tissue from the opening are shown;

[0039] Fig.17 and Fig.18 An embodiment of an arrangement of a shaft and a perforator suitable for the device of the present invention and suitable for removing a perforated bone awl is shown;

[0040] Fig.19 , Fig. 20A , Fig. 20B , Fig.21 Other embodiments of apparatus suitable for the device of the present invention are shown, the apparatus also comprising a protective cannula;

[0041] Fig. 22 Another embodiment of the arrangement of the shaft and the perforator suitable for the device of the present invention and suitable for removing the perforating bone awl from the operative side is shown;

[0042] Fig.23 An embodiment of a perforator suitable for the device of the present invention is shown in axial section and cross section;

[0043] Fig.24A and 24B Two alternative ways of perforating the compact bone layer using the device of the present invention are shown;

[0044] Figures 25A to 25C An exemplary cross section of a shaft suitable for the device of the present invention and used to reinforce a long shaft is shown;

[0045] Figures 26A to 26E An exemplary distal end of a perforator suitable for the apparatus of the present invention is shown;

[0046] Figures 27A to 27D Another variation of the distal end of a perforator suitable for the device of the present invention is shown;

[0047] Fig.28 An embodiment of an apparatus suitable for use with the device of the present invention is shown;

[0048] Fig.29 Another embodiment of the arrangement of the shaft and the perforator suitable for the device of the present invention is shown;

[0049] Fig.30 Another embodiment of a shaft and perforator arrangement suitable for the device of the present invention is shown. DETAILED DESCRIPTION

[0050] In all drawings, the same reference numerals indicate the same components or similar components that perform the same function.

[0051] Figure 1 A straightforward way of perforating a compact bone layer 1 using the device 10 of the invention is shown in a very schematic manner, wherein: Figure 1The left side of the device 10 for positioning the perforation process is shown, and the right side shows the perforated compact bone layer and shows the expected flow of blood, oxygen and / or cells through the perforation. As mentioned further above, the compact bone layer is located between the repair site 2 (outside of the compact bone layer) and the region 3 or layer (inside of the bone layer) of trabecular bone and / or bone marrow, wherein there is usually a gradual transition between the compact bone layer and the trabecular bone tissue, rather than the clear lines as shown in the figure separating the two. The compact bone layer 1 is, for example, a subchondral bone plate, and the repair site 2 is a position where the cartilage 4 covering the subchondral bone plate 1 is missing or needs to be repaired, strengthened, enlarged or possibly ossified. The perforation process is, for example, a part of an open surgery performed on a human or animal patient.

[0052] like Figure 1 The device 10 shown is in the form of an ultrasonic handpiece and includes a handle 11 that accommodates a vibration generator (not shown), a shaft 12 connected to the vibration generator, and a substantially cylindrical perforator 13 that is substantially coaxially connected to the distal end of the shaft 12. During the perforation process, the distal side of the perforator 13 is positioned and close to the outer surface of the compact bone layer 1 (arrow F) so that the main axis of the perforator forms an angle of, for example, about 90° with the bone surface. In addition, the vibration generator is activated to vibrate the perforator 13 (double-headed arrow V), and the device may be forced against the compact bone layer 1 (direction of arrow F), and then the perforator 13 is driven into and preferably passes through the compact bone layer 1 to form an opening 20, and then the perforator 13 is removed from the opening 20. Preferably, as Figure 1 As shown on the right side of the , a plurality of openings 20 are formed. Once the perforator 13 is removed from the opening 20, the fluid material flows from the inner side of the compact bone layer 1 to the outer side thereof (as shown by the small arrow), especially the blood carrying oxygen and cells, and forms a blood clot 22 on the outer side of the compact bone layer 1, which can achieve and / or enhance tissue growth or tissue repair in the repair site 2.

[0053] Figure 2 With Figure 1 The same schematic method shows an indirect method of perforating the compact bone layer 1 using the device of the present invention. For this perforation process, the perforator 13 is connected to the distal end of the shaft 12 at a certain angle and is positioned against the compact bone layer 1 by approaching the device 10 in the direction indicated by the arrow F (i.e., substantially parallel to the compact bone layer 1). Figure 2 The perforation process shown is, for example, part of a minimally invasive surgical procedure on a joint of a human or animal patient, wherein the compact bone layer to be perforated is one of a pair of subchondral bone plates (1 and 1') that are opposite each other in the joint. Figure 2In another exemplary application of the illustrated procedure, the compact bone layer 1 to be perforated is the cortical bone layer of one of a pair of adjacent vertebrae facing the intervertebral space from which the intervertebral disc and possibly the cartilage tissue covering the subchondral bone plate have been partially or completely removed.

[0054] Figures 3 to 8 Various embodiments of an instrument suitable for the device of the present invention are shown, the instrument comprising a shaft 12 and a distal end member having a perforator 13, wherein only the distal portion of the shaft 12 is shown. To further illustrate the vibration mode required of the instrument, Figures 3 to 5 The corresponding diagram is shown on the right. Figures 3 to 8 In the embodiment, the perforator 13 is provided with Fig. 9 The cylindrical form of the tapered tip is further shown. However, as follows Figures 10 to 14 All other embodiments of the perforator shown are also applicable Figures 3 to 8 The instrument shown. In particular, the perforator can be in the form of a prism.

[0055] according to Figure 3 The device comprises a perforator 13 and a shaft 12, which has, at least in its distal region, a substantially identical cross section to the perforator 13. The shaft 12 and the perforator 13 are made in one piece or in two rigidly connected pieces having the same main axis A, which makes the device suitable for use according to Figure 1 The shaft 12 and the perforator 13 are designed to vibrate mainly longitudinally in a standing wave (double arrows SA and PA) having an antinode position in the distal region of the perforator 13, as shown in the vibration diagram on the right side of the figure.

[0056] Figure 4 The apparatus shown in Figure 3 The present invention relates to an instrument in the present invention, but the perforator 13 is only loosely coupled or not coupled to the shaft 12. Therein, the shaft 12 is designed and activated to vibrate mainly longitudinally in a standing wave (double arrow SA) having an antinode position at the distal side of the shaft, wherein only the half wave pointing distally is transmitted to the perforator 13, resulting in a series of intermittent impacts on the perforator 13 (arrow P1).

[0057] Figure 3 and Figure 4 Both instruments shown may be further equipped for creating an opening with a limited depth. The element for such depth limitation may include a full or partial collar extending radially from the perforator 13 or from the distal shaft end region at a corresponding axial distance from the distal surface of the perforator (see also Fig.10 ). Figure 4 In an embodiment of the present invention, if the shaft 12 has a correspondingly larger cross-section than the perforator 13, an outer ring on the distal side of the shaft 12 can be used as a depth limiting element.

[0058] Figure 5 and Figure 6 An instrument suitable for the device of the present invention is shown, which comprises a shaft 12 and a distal end member having a perforator 13, which is suitable for indirect means ( Figure 2 The punch 13 is arranged relative to the shaft 12 so that the main axis A does not coincide with the main axis B of the punch, but forms an angle with the main axis B of the punch, for example, an angle of 90° as shown in the figure, and the punch 13 is rigidly connected to the shaft 12 ( Figure 5 ), or loosely connected or not connected ( Figure 6 ) to the shaft. The shaft 12 is designed and activated to vibrate mainly in the longitudinal or axial direction or in addition to the longitudinal or axial vibration (double-headed arrow SA) in a transverse or bending vibration mode (double-headed arrow ST), and the node position of the bending vibration ST is located at the antinode position of the axial vibration SA. The perforator 13 is connected to the shaft 12 or the shaft position acting on the perforator is the node position of the axial shaft vibration (SA), that is, the antinode position of its bending vibration (ST), which will generate axial or longitudinal vibration (double-headed arrow PA, Figure 5 ), the perforator 13 is preferably designed for the location of the antinode of the vibration PA in the region of its distal side. In the case where the perforator 13 is not rigidly fixed to the shaft 12 ( Figure 6 ), the vibration of shaft 12 is only combined with Figure 4 The same approach discussed is partly transferred to the perforator 13, ie the shaft 12 will act on the perforator 13 by a series of intermittent hammer blows (arrows PI).

[0059] When using Figure 5 and Figure 6 During perforation of the compact bone layer by the illustrated instrument, the depth of the opening to be created is limited by the shaft 12, i.e. the depth is limited to a maximum equal to the axial length of the perforator 13. However, in order to limit the depth of the opening to be created, e.g. Fig.10 The further depth limiting elements shown may also be provided on the perforator 13 .

[0060] Figure 7 and Figure 8 Very schematically, two further examples of instruments suitable for the device according to the invention are shown, again comprising a shaft 12 and a distal end piece with a perforator 13, wherein the main axis A forms an acute angle ( Figure 7 ) or obtuse angle ( Figure 8 ).and Figure 5 and Figure 6 All comments and explanations related to Figure 7 and Figure 8 .

[0061] Figures 9 to 13An embodiment of a perforator 13 suitable for the device of the present invention is shown, and all perforators shown can be applied to Figures 3 to 8 In any of the devices shown.

[0062] Fig. 9 and Fig.10 A solid punch 13.1 is shown which, in addition to a cylindrical or prismatic main portion, comprises a tapered distal tip 14. If the tip 14 is in the shape of a pyramid, the edges of the pyramid are preferably sharp or serrated and may be flat or concave together with the surface portion between the edges. Instead of comprising a tip 14, the distal side of the solid cylinder may be as Fig. 9 It is shown as being concave, which is indicated in dashed lines with reference numeral 14.1 and includes a sharp or serrated distal edge.

[0063] In accordance with Fig. 9 In the perforator of the invention, the maximum (most proximal) cross section of the tip 14 is the same as the cross section of the cylindrical portion, but in accordance with Fig.10 In the case of the perforator of , it is slightly larger (e.g. at least 0.1 mm larger), which leads to an even further reduction in lateral friction upon impact. Fig.10 The perforator comprises a depth limiting element 15, the cross section of which increases in a step-like manner. Such a symmetrical or asymmetrical depth limiting element can be arranged at Figures 9 to 13 On all perforators shown.

[0064] Fig.11 and Fig.12 A blade-shaped or chisel-shaped solid perforator 13.2 is shown having a narrow elongated cross-section and a distal edge 18 which may be straight ( Fig.11 ), or you can form an intermediate point ( Fig.12 ), but can also be curved or form lateral points.

[0065] Fig.13 A hollow punch 13.3 is shown with a distal wall portion tapering toward the distal edge 18, the tapering preferably being limited to the interior of the hollow cylinder, which results in less lateral bone compaction than an external tapering. As described above for a solid punch, a slight reduction in the diameter of the main proximal cylindrical portion due to a tapering of, for example, 0.02 mm to 0.1 mm can help further reduce lateral friction upon impact.

[0066] As mentioned further above, Fig. 9 , Fig.10 and Fig.13 The perforator shown may have a circular cross section as shown. However, this is not a condition of the present invention. These cross sections may also be elliptical, polygonal or any desired shape.

[0067] As mentioned further above, Figures 11 to 13 The distal edges of the perforators 13.2 and 13.3 shown are preferably sharp or serrated, with the serrations being regular or substantially random and having a size in the visible or sub-visible range.

[0068] Fig.14 Another embodiment of an instrument suitable for the device of the present invention is shown, which comprises a shaft 12 (only the distal portion is shown) having a plurality of perforators 13 on its distal side, wherein these perforators 13 can be, for example, in the form of Figures 9 to 13 The shape of any of the perforators 13.1, 13.2 or 13.3 shown or described herein. The combination of the shaft 12 and the plurality of perforators 13 is used to simultaneously create multiple openings in a compact bone layer, wherein the shaft 12 has a correspondingly larger cross-section than each perforator 13, and wherein the shaft distal surface can serve as a depth limiting element.

[0069] Fig.15 An opening 20 is shown through the compact bone layer 1, which is provided by means of, for example, Fig. 9 or Fig.10 The solid perforator formation shown has, for example, a depth through the compact bone layer 1 into the trabecular bone tissue 3, wherein bone compaction is found only below the bottom of the opening 20 (compacted bone tissue area 21), leaving the side walls 22 of the opening completely unaffected.

[0070] Fig.16 1 is a cross-sectional view of the distal portion of an exemplary angled instrument suitable for the device of the present invention, the instrument comprising a distal end piece with a hollow perforator 13.3 and a shaft 12, both rigidly fixed to each other at an angle of, for example, 90 degrees. The illustrated instrument is shown in the process of forming an opening through a compact bone layer 1, and the distal edge of the perforator 13.3 has reached the trabecular bone tissue 3 below the compact bone layer 1.

[0071] Fig.16The device shown is particularly suitable for forming a series of openings before being removed from the repair site of the compact bone layer to be perforated thereon, and is suitable for removing bone tissue from the opening together with the device. For this reason, the shaft 12 includes a transverse through hole 23 at its distal end portion, which is aligned with the channel of the hollow perforator 13.3 and includes a cross section at least adjacent to the perforator 13.3, which is similar to the cross section of the internal perforator channel. The through hole may further include a portion 23' with a larger cross section. Bone debris 25 that is flushed out from the first opening produced by means of the perforator 13.3 is, for example, retained in the perforator, and the bone debris that will be pushed out of the perforator through the second or third opening created after the first opening enters the through holes 23 and 23' of the shaft 12. Wherein, the vibration of the shaft 12 and the perforator 13.3 promotes the transportation of bone debris through the hollow perforator 13.3.

[0072] If the transverse opening 23 through the shaft 12 does not include Fig.16 As shown in the enlarged portion, bone debris can be removed from the shaft 12 and hollow punch 13.3 after it has been removed from the repair site using a suitable needle. Figure 3 In the illustrated linear instrument including a hollow perforator, bone debris can be collected in the respective hollow distal end of the shaft and can be removed by detaching the perforator from the shaft after the instrument is removed from the repair site. To remove debris, a lateral opening can also be provided in the hollow perforator 13.3, through which the debris is pushed and transported away therefrom together with water used to continuously flush the repair site, especially in arthroscopic surgery.

[0073] Fig.17 and Fig.18 A further embodiment of an apparatus suitable for use with the device of the present invention is shown. Fig.17 and Fig.18 The instrument shown is particularly suitable for forming a series of bone openings before being removed from the surgical site, and is suitable for removing bone tissue (especially the complete bone fragments that are punched out) from the openings produced using the instrument. For this reason, the hollow perforator 13 includes a cutting tube 40 at its distal portion. The cutting tube can terminate at an opening 41 of the perforator, and the cross-section of the opening is larger than the cutting tube. Bone fragments 42 punched out from the opening formed by the perforator 13 can be stored in the opening 41. Therefore, the perforator can include an opening 41, which is suitable for use as a reservoir for bone fragments or bone debris. The perforator 13 can be designed as a disposable item, suitable for forming multiple bone openings in an operating side and storing the bone fragments (pressed out or punched out) produced. After being removed from the operating side, the bone fragments can be used as test samples or allograft materials. The perforator may be discarded (with or without bone fragments) or easy to clean. Fig.17The illustrated embodiment is designed so that vibration of the shaft 12 and punch 13 promotes the passage of bone fragments 42 through the hollow punch and retains them in the opening 41. The shaft 12 may have external threads 25 and the punch internal threads 26 to ensure proper connection of the two elements.

[0074] exist Fig.18 In the illustrated embodiment, hydraulic pressure can be used to further transport bone fragments. Therefore, there may be a channel in the shaft 12 for supplying a liquid such as water from the handle to the perforator. The liquid flow can be stopped or reversed to generate negative pressure. Alternatively, liquid can be used to transport (or spray) bone fragments outside the cutting tube. Bone fragments can be sprayed to the operating side and washed out using a liquid (e.g., from blood) that is usually used to clean the operating side. When using this alternative, the liquid flow into the perforator will not stop, but at the moment when the perforator cuts into the bone, the outflow of liquid stops. Therefore, the pressure in the perforator increases, and this pressure can be used to remove bone fragments from the perforator. If negative pressure is used to transport and store the bone fragments that are flushed out, the bone fragments are sucked out. This supports the process of breaking up the compact bone part that is flushed out. Therefore, it is possible to remove the bone in the cutting tube in one piece, and the damage to the surrounding tissue is less.

[0075] Fluid supplied through the instrument may also be used to cool the instrument and perforator, to fill the connector, and / or to irrigate the operative side. Fig.19 , Fig. 20A , Fig. 20B , Fig.21 ) can be used to aspirate fluid and bone debris away from the operating side.

[0076] Fig.19 , Fig. 20A , Fig. 20B , Fig.21 An embodiment of the device of the present invention is shown which is particularly suitable for arthroscopic or minimally invasive surgery by including an elongated shaft 12 located in a cannula 30, from the distal end of which a perforator 13 extends and is preferably retractable into the cannula before and after the perforation procedure. Fig.19 , Fig. 20A , Fig. 20B , Fig.21 Only the distal portions of the shaft 12 and cannula 30 and the perforator 13 are shown.

[0077] The cannula 30 guides the shaft, which for such minimally invasive applications is typically long (in the range of 50 mm to 100 mm) and as thin as possible, and furthermore the cannula remains substantially dry and free from contamination by tissue components, but it also protects surrounding tissue from undesirable interactions with the vibrating shaft. The guiding function of the cannula can be further improved by designing the combination of the shaft 12 that is activated in the primary longitudinal vibration and the cannula 30 that is used to protect the shaft to have reduced radial play at locations where the longitudinal vibration of the elongated shaft includes a node location (an antinode location of undesirable radial vibration). To achieve this improved guiding function, at specified locations, the cannula can include a reduced internal cross-section or the shaft includes an enlarged cross-section.

[0078] The distal edge of the cannula 30 may be a sharp and / or serrated edge or may include pin-shaped protrusions to adapt the cannula 30 for fixation at a repair site by slightly embedding the distal edge into the tissue.

[0079] Additionally, the cannula may be equipped with fluid conduits for supplying fluid to the repair site (eg, saline solution for flushing the repair site) and / or for removing fluid from the repair site (eg, saline solution or excess blood, and possibly bone debris as mentioned above).

[0080] according to Fig.19 The device includes a rod 12 and a perforator 13 or multiple perforators extending from the distal end of the cannula during, before and / or after the perforation process, and the device can be retracted so that the perforator 13 is protected inside the distal part of the cannula 30 (retracted position shown by the dotted line).

[0081] Fig. 20B The distal portion of the shaft 12 within a cannula 30 (e.g., an arthroscopic tube) is shown in axial section. The instrument can be moved in a distal direction relative to the passage. Within the cannula 30 is a lumen, which is, for example, a lumen for an optical instrument (camera) used in arthroscopy. A perforator 13 is included at the distal end of the instrument. The instrument has at least one portion 18 with a larger cross section at a node position N (λ / 4). The larger cross section may be caused by a ring around the wall of the instrument. The ring may be a polymer ring or a ring made of the same material as the instrument. The portion 18 may also be more precisely at a set site. There may be three or four sites around the instrument.

[0082] Alternatively or additionally, the cannula 30 may include at least one portion 19 of larger cross section at the node position N (λ / 4). The larger cross section may be formed by a protrusion of the cannula wall. The protrusion may be an integral part of the cannula wall and may be formed as a ring with a square cross section. Alternatively, there may be several rectangles forming a circle around the sonotrode with certain spacing between them. These rectangles may be arranged at uniform spacing on the circle. In addition to rectangles, there may be spherical protrusions attached to a circle around the circumference of the sonotrode. The circle is always located at the node position N. This embodiment is Fig. 20A 30 is shown in the cross section of the cannula 30 shown. It can be seen that three or four rectangular protrusions form a larger cross section of the channel. Between these protrusions is a free space, which can be used as a space for liquid (cooling / flushing). A polymer sleeve 31 can be attached at the distal end of the cannula 30, which can reduce friction losses. The sleeve can be made of a polymer such as PEEK and attached to the inner surface of the cannula 30. Alternatively, the shaft 12 or perforator 13 may have a polymer sheath attached to its distal end.

[0083] according to Fig.21 The cross-section of the shaft 12 is larger than the cross-section of the perforator 13, and the cannula 30 has a partially closed distal end, and the cross-section of its distal opening 31 is reduced to be smaller than the cross-section of the shaft 12, thereby limiting the axial movement of the instrument distally in the cannula 30, thereby limiting the depth to which the perforator 13 can hit the compact bone layer, that is, limiting the depth of the opening to be formed.

[0084] Fig. 22 Shows something like Fig.18 and 19 The present invention provides an embodiment of an arrangement of a shaft 12 and a perforator 13, which is suitable for producing a series of bone openings before removal from the surgical site, and for removing bone tissue (particularly complete bone fragments punched out) from the openings produced using the instrument. For this purpose, the hollow perforator 13 comprises a cutting tube 40.1 at its distal end portion. The cutting tube may terminate at an opening of the perforator, which has a larger cross-section than the cutting tube and is suitable for storing bone fragments 42. The perforator 13 can be designed for single use, suitable for forming several bone openings in one operating side and storing the bone fragments (pressed out or punched out) produced.

[0085] Fig. 22The embodiment is designed so that vacuum promotes the transport of bone fragments 42 through the cutting tube 40.1 and keeps it in the perforator. Therefore, there may be a channel 43.1 in the shaft 12 for evacuating air and applying vacuum in the perforator. The channel 43.1 can be formed to extend along the longitudinal axis of the shaft 12. The channel can extend laterally from the shaft 12. This means that the proximal part of the channel 43.1 extends perpendicular to the longitudinal axis and the distal part of the channel. Alternatively, the channel 43.2 can be attached to the flange protruding from the perforator 13. At the height where the flange protrudes from the perforator, the circumferential groove 44 can be located in the perforator wall. The groove extends once around the entire circumference (dashed line). Preferably, the channel 43.1 or 43.2 is attached to the instrument at the node position (λ / 4). After each operation (each patient treatment), the channel 43.1 included in the shaft 12 or in the handle must be cleaned. The passage 43.2 integrated in the perforator 13 has the advantage that it does not have to be cleaned when the perforator is a disposable item, or is easier to clean because it is very short and has no curved structure. On the other hand, it is more expensive to include such a passage in the perforator, particularly when it is a disposable item. The vacuum can also be used to support or promote the breaking up of the part of the compact bone that is punched out. Therefore, it is possible to remove the bone in the cutting tube in one piece, while the damage to the surrounding tissue is less.

[0086] like Fig. 22 As shown, the cutting tube of the perforator can extend into a space within the perforator, such as a siphon tube. Fig. 22 Possible cross sections of the cutting tube are also shown. The cutting tube may have ribs 50 on its inner side. These ribs may be parallel to the longitudinal axis of the cutting tube and extend along the entire length of the cutting tube, or may be arranged only in the distal portion outside the perforator opening. The ribs may alternatively form a spiral or bend on the inner side of the cutting tube. Ribs or protruding spikes or alternative protruding elements attached to the inner side of the cutting tube may help to break up bone fragments after the cutting tube is introduced into compact bone. Therefore, the cutting tube or the entire instrument must be rotated so that torsion is applied to the bone fragments in the cutting tube. These cutting tubes may be manufactured by extrusion or additive manufacturing processes.

[0087] Fig.23 Another embodiment of a cutting tube or perforator is shown. Slicing elements 51 are arranged inside the tube or perforator. These elements are suitable for cutting or breaking up the bone core into small fragments or bone debris that can be sucked out of the perforator. The slicing elements can be formed as thin blades (e.g. two, three, four or five blades) that are arranged in a manner that intersects each other at the central axis of the tube, such as Fig.23 The cutting tube can cut into the compact bone through its distal end, and when cutting deeper into the bone, the slicing element cuts the bone core into smaller fragments. The distal end of the slicing element or blade can be sharp and can be beveled.

[0088] Fig.24A and 24B Two different methods of perforating a compact bone layer 1 using the device of the present invention are shown, in order to be able to transport blood, living cells and / or oxygen from the inner side of the compact bone layer to the opposite outer side of the compact bone layer. Fig.24A In the method, the device used introduces several microscopic holes. The holes may have different cross-sections, such as rectangular, oval or irregular shapes. The cross-section is preferably circular and may have a diameter of 1-2 mm. The perforator used in this method may have a solid distal end and push the compact bone material into the trabecular part of the bone thus compacted. Alternatively, as Fig. 24B As shown, the device used comprises a hollow perforator or at least a hollow cutting tube of a perforator, and the bone awl is not removed. Fig.26B Results are shown of a method of perforating a compact bone layer for the purpose of allowing blood, living cells and / or oxygen to be transported from an inner side of the compact bone layer to an opposite outer side of the compact bone layer, the method comprising:

[0089] A device according to the invention is provided, comprising a vibration generator, a shaft defining a main axis and a distal end piece having a hollow, substantially cylindrical perforator, the perforator defining a main axis of the perforator, the device being positioned such that the main axis of the perforator is oriented substantially vertically relative to the compact bone layer and the distal end of the perforator is positioned against the compact bone layer; activating the vibration generator and holding the perforator against the compact bone layer for a time sufficient to form a substantially cylindrical opening through or at least into the compact bone layer; removing the perforator from the opening, whereby the cross section of the substantially cylindrical opening is substantially annular. This means that a bone core remains within the substantially cylindrical opening. This bone structure is in contact with the underlying trabecular bone and optionally also with a deeper part of the compact bone, but there is a cut in the compact bone with a closed geometry, while in the middle the bone structure has the complete (original) bone thickness to be treated. The annular cross section of the cylindrical opening may have a diameter of 0.1 mm to 0.75 mm, and preferably has a diameter of 0.25 mm to 0.5 mm.

[0090] In order to produce a substantially cylindrical opening with a substantially annular cross section, a larger exudation surface is obtained with the same number of perforations. The periphery of the cylindrical opening is the source of bleeding, with the bone core located in the middle. At the same time, the bone is not fragile, or even so brittle. The device of the present invention is suitable for this method because the geometry of the perforator is optimized to minimize the thermal impact on the bone and minimize the formation of debris.

[0091] Figures 25A to 25CThree alternative cross sections of shaft are shown, which are suitable for increasing the rigidity of shaft. The shaft can have a double T, Z or X-shaped cross section, and of course the cross section can also be oval, circular or rectangular. Similarly, the instrument with a shaft that is not circular can be suitable for being fitted on a circular or oval perforator. This can be completed by the corresponding design of the proximal end of the perforator or the distal end of the shaft. Alternatively, an adapter can be present between two elements that transmit vibration from the shaft to the perforator.

[0092] Figures 26A to 26E An alternative arrangement of the distal end of the perforator suitable for the device of the present invention is shown. Fig.26A In the embodiment of the present invention, the hollow distal end of the perforator or cutting tube can be sharpened to produce a peak or tip. Such a peak can enhance the piercing ability of the perforator according to the present invention. The peak should preferably be located so that it is the first structure to perforate the bone. Therefore, the peak can be located on the outside, inner edge or middle of the perforator wall. Alternatively, the distal portion of the perforator can be formed with different cut surfaces. Each cut surface is a cut surface located at the distal edge. Therefore, three or more peaks may appear on the distal end, and different cut surfaces may collide with each other.

[0093] Fig.26B Also shown is the sharp distal end of the perforator or the cutting tube included by the perforator. The distal end of the perforator or its cutting tube has a groove 52, which defines a sharp distal cutting edge. The groove consists of a groove 16 extending on the inner side of the perforator or its cutting tube and extending parallel to the distal cutting edge. The wall of the perforator in the groove 52 is thinner than the wall of the distal cutting edge. The wall in the groove can be 0.05 mm to 0.5 mm lower than the edge. The minimum depth of the groove is sufficient to fully reduce friction. Preferably, the wall of the perforator or the wall of its cutting tube increases suddenly or gradually toward the proximal end. Alternatively, the distal cutting edge has a thicker wall than the remaining cutting tube or perforator. In this case, 52 refers to a step rather than a groove. Therefore, the distal end of the perforator or its cutting tube may include a step 52, wherein the wall thickness increases in a manner that the distal wall of the step is thicker than the proximal side of the step. The groove or step 52 can also be located on the outside of the perforator or its cutting tube.

[0094] Fig.26C The distal end shown is similar to Fig.26B The distal end shown in FIG. 1 is a piercer or a cutting tube, but there is a groove 52 on the inside of the distal end of the piercer or its cutting tube, and another groove 53 on the outside. Again, 52 and / or 53 may also refer to steps in the wall of the piercer or its cutting tube. Steps 52 and 53 may also be designed to form a curvature.

[0095] exist Fig.26DIn the illustrated embodiment, the distal cutting edge of the perforator or its cutting tube is formed by a ring 54 inserted or pressed into the distal end of the perforator or its cutting edge. The ring can be made of a material different from the perforator or its cutting tube. The ring can be made of metal, alloy or ceramic, or any material that is sufficient to cut bone. The ring can be designed to form a sharp distal edge.

[0096] Similar to Fig.26D Ring 54 in Fig.26E A ring or portion of a ring 55 is shown placed on the distal end of a perforator or its cutting tube and welded (by laser or ultrasound) to the wall of the perforator or its cutting tube. The remaining material 56 after welding is located at the proximal end of the ring 55. The ring 55 can form a sharp cutting edge for introduction into bone, where the wall of the perforator or its cutting tube can be thinner. The minimum thickness of the wall is sufficient to sufficiently reduce friction.

[0097] Figures 27A to 27D Another embodiment of the arrangement of the distal end of the perforator or its cutting tube suitable for the device of the present invention is shown. The distal end is alternately folded. Therefore, the tubular distal end has at least two cuts. The part between the cuts is alternately folded inwards or outwards. Fig.27A The distal end is shown with the cutout prior to folding. Fig.27B The parts 57 and 57' are shown folded outwards, wherein the middle part has been folded inwards. Fig.27C A cross section of the distal end of the fold with four cuts is shown, with portions 57, 57' folded outwardly and portions 58 and 58' folded inwardly. The fold should be formed in such a way as to produce a sharp cutting edge 18, such as Fig.27D Shown is the cut at AA´.

[0098] Fig.28 The apparatus of the present invention is shown, which comprises a shaft 12 and a perforator 13. The perforator has been pressed into the shaft 12 (shown in dotted lines) and is laser welded to be fixed. The perforator can be a hollow tube with a length of 10 to 14 mm, an external cross section of 1 to 1.4 mm, and an internal cross section of 0.6 to 1 mm. The length of the perforator shaft outer part is about 7 mm. The outer diameter of the cross section of the shaft can be 3 mm to 5 mm. The shaft has been press-fitted into a base 61 with a proximal element 60 (thread or plug-in), which is used to be connected to a handle and / or a vibration generator.

[0099] Fig.29 Shows something like Fig.28Embodiments of the arrangement of the shaft 12 and the hollow perforator 13. The angle α and the mass of the element 17 influence the axial amplitude of the vibrations. The mass of the element 17 can be selected in such a way that the maximum amplitude is at the point 62. In the case of an angle α close to 0°, the position 62 is λ / 4. The element 17 can be annular with increasing wall thickness. Alternatively, it can include at least two solid objects 17 and 17´ symmetrically attached to the shaft 12.

[0100] Fig.30 Shows something like Fig.28 Embodiment of an arrangement of a shaft 12 and a hollow perforator 13. The shaft 12 is a hollow tube with an obliquely cut distal end. The distal end may be closed by a plate which may be welded to the tube. The hollow perforator (in tubular form) may be pressed into the plate and welded to the plate (see residue 56.1). The plate may serve as a depth limiting element. The outer diameter of the perforator may be between 6 mm and 10 mm. The angle α may be >90° and <180° and preferably between 120° and 150°. The geometry of the shaft 12 may have any shape described herein, for example there may be a space 42 for storing bone fragments. There may be a supply of cooling liquid from the handle to the inner stroke of the shaft 12 (not shown). In addition, the distal end of the perforator may be as Figures 26A to 26E and Figures 27A to 27D Design as shown.

[0101] Similar to Fig.29 and Fig.30 With the arrangement of the shaft 12 and the hollow perforator 13 shown, the cutting tube 40 can also be attached to the perforator 13 obliquely.

Claims

1. A device (1) for perforating a compact bone layer, the device comprising a vibration generator for generating mechanical vibrations and an instrument having a shaft (12) and a distal end member including a perforator (13), wherein the shaft (12) has a distal end, a proximal end and a main axis (A) extending between the proximal end and the distal end, wherein the distal end member is arranged at the distal end of the shaft (12) and the proximal end of the shaft is connected to the vibration generator, wherein the perforator (13) comprises a solid or hollow cylinder or prism defining a main axis (B) of the perforator, and wherein the vibration generator, the shaft (12) and the distal end member are adapted to each other so that the shaft (12) when connected to an activated vibration generator transmits mechanical vibrations from the vibration generator to the distal end member and causes the perforator (13) to vibrate in a direction parallel to the main axis (B) of the perforator; in, The perforator (13) comprises a cutting tube (40); The cutting tube (40) includes a slicing element (51) in an internal space suitable for bone cutting.

2. The device according to claim 1, wherein: The main axis (A) and the punch main axis (B) form an angle greater than 90° and less than 180°.

3. The device according to claim 1, wherein: The perforator (13) or the shaft (12) comprises an opening (41) adapted to store removed bone fragments (42).

4. The device according to claim 3, wherein: The shaft (12) or the perforator (13) comprises a conduit (43) suitable for supplying a liquid to the opening (41) or applying a vacuum to the opening (41).

5. The device according to claim 1, wherein: The shaft (12) is designed to vibrate in a transverse mode or a bending mode, or wherein the shaft (12) is designed to vibrate in a longitudinal mode, the distal end member with the perforator (13) is designed to deflect the longitudinal shaft vibration into a longitudinal vibration along the direction of the main axis (B) of the perforator.

6. The device according to claim 1, wherein: The punch (13) is a solid cylinder and comprises a concave distal side having a distal edge (18).

7. The device according to claim 1, wherein: The punch (13) is a hollow cylinder and comprises a distal edge (18).

8. The device according to claim 7, wherein: The hollow cylinder includes an inner side and an outer side and a wall thickness therebetween, wherein the wall thickness tapers toward the distal edge (18) to form a cutting end suitable for cutting compact bone.

9. The device according to claim 8, wherein: The tapering is limited to the inner side of the hollow cylinder.

10. The device according to claim 8, wherein: The distal edge (18) comprises an inner groove (52) and / or an outer groove (53).

11. The device according to claim 7, wherein: The distal edge (18) comprises a ring which is clamped in the opening of the perforator (13).

12. The device according to claim 7, wherein: The distal edge (18) is formed by a ring welded to the perforator (13).

13. The device according to claim 7, wherein: The distal edge (18) is formed by alternating outwardly folded portions (57) and inwardly folded portions (58).

14. The device according to claim 7, wherein: The distal edge (18) is sharp or serrated.

15. The device according to claim 1, wherein: The distal end of the shaft (12) or the perforator (13) comprises a depth limiting element.

16. The device according to claim 1, further comprising a cannula (30), wherein The shaft (12) extends in the longitudinal passage of the cannula (30).

17. The device according to claim 16, wherein: The distal edge of the cannula (30) is a sharp or serrated edge.

18. The device according to claim 16, wherein: The distal edge of the cannula (30) includes a pin-shaped protrusion extending therefrom.

19. The device according to claim 16, wherein: The distal piece with the perforator (13) can be retracted into the distal end of the cannula (30).

20. The device according to claim 16, wherein: The cannula (30) also includes at least one conduit for delivering fluid to and / or away from the repair site.

21. The device according to claim 2, wherein: The perforator (13) includes a protruding element (50) on an inner surface adapted to apply a torsional force to the cut bone.

Images