WO2017114774A1

WO2017114774A1 - Nail device

Info

Publication number: WO2017114774A1
Application number: PCT/EP2016/082529
Authority: WO
Inventors: Norbert De Jonghe
Original assignee: Jeannor Bvba
Priority date: 2015-12-30
Filing date: 2016-12-23
Publication date: 2017-07-06

Abstract

The current invention concerns a nail device 1, 2 for repairing bone defects 26, suitable to be attached to two main bone fragments 3, 4 and extending over a bone defect 26 located between said bone fragments 3, 4, whereby the length of the device 1, 2 between the main bone fragments 3, 4 is able to increase and/or decrease in a hydraulic way, so that new bone tissue in the caused openings can be formed, the nail device 1, 2 comprising: ‒ a proximal end part 5 comprising one or more proximal locking holes 6 and a hydraulically activatable actuator 22; ‒ a distal end part 7 provided with an axially extendable nail 8, said nail 8 comprising distal locking holes 9; ‒ a housing 10 extending between said proximal end part 5 and said distal end part 7, said housing 10 comprising an internal bore 11 in which the nail 8 is centrally and axially extendable provided; and ‒ a fluid supply assembly for the supply of hydraulic fluid which is connectable with said proximal end part (5), wherein said proximal end part (5) comprises a radially oriented socket (33) which is arranged for the mechanically detachable and reversible engagement of said fluid supply assembly. In another aspect, the invention relates to a targeting jig 35 for the installation of a nail device 1, 2 for repairing bone defects. In still another aspect, the invention relates to a kit for the installation of a nail device 1, 2 for repairing bone defects. The invention further concerns a method for installation of a nail device and a method for adjusting a nail device.

Description

NAI L DEVI CE

TECHNICAL FIELD The invention relates to a nail device for repairing bone defects. The nail device is suitable to be attached to two main bone fragments and extending through the bone defect, whereby the length of the device between the bone fragments can increase and/or decrease in a hydraulic manner causing spaces where bone tissue can be developed and grow to the bone. In another aspect, the invention relates to a targeting jig for the installation of a nail device for repairing bone defects. In still another aspect, the invention relates to a kit for the installation of a nail device for repairing bone defects.

BACKGROUND

In the prior art bone distractors, or also even in the English literature, lengthening nails are known.

A known nail device from Folia Traumatologica Lovaniensia 2007, "The hydraulic lengthening nail for lengthening the lower limb. A prospective cohort trial of thirty- four nails" ISBN 90807978 p.74-82 comprises a proximal end provided with proximal locking holes, a hydraulic active actuator, and a distal end provided with an extendable nail or bar, the nail provided with distal locking holes. The locking apertures are suitable for lifting up the corresponding screws so that the proximal part of the device is attached to the proximal main bone fragment and according to the distal side of the nail to the distal main bone fragment. The nail is axially extendable contained in a cylindrical housing by means of a hydraulic system. After application of the device the pressure in the cylindrical housing is being increased once every day, through the connection of an external hand pump. This pressure increase pushes the lowest nail down. When this shift happens slowly (0.5 to 1.3 mm / 24 h), bone tissue is spontaneously grown in the distraction space, which makes it possible to extend the bone up to 8 cm.

The disadvantages of this known nail are numerous. The supply of hydraulic fluid takes place by means of a rigid metal supply tube, which is connected radially sideways to the actuator. This provides sealing problems and increases the risk of infection. This known device is being fixed into a desired end position of the bar through many of the provided drilling operations, so that the mechanical strength is significantly weakened.

In addition, there are currently three systems globally applicable: a) the ring fixator 5 of Gavriil A. Ilizarov US patent No.4615338, b) the mechanical lengthening nail of J.M. Guichet (also referred to as Albizzia nail) WO 200404531, Grammont Paul CA 1335952, Alexander Bliskunov US patent No 7530981, J. Dean Cole (also referred to as ISKD nail) US patent No. 7 018 380 and 7 041 104 and c) the elektronical lengthening nail of A. Betz (also referred to as fitbone) from US patent No. 6 245 10 075.

With Ilizarov, no matter which device can be applied for compression and lengthening, the limb is being fixed by means of several rings connected to the bone with thin metal pens. To guarantee the stability of the construction, the pens

15 are being put under pressure (100 kg). For each ring two metal pins need to be drilled through the member. The bone is being lengthened through external threaded rods. By replacing a few nuts on the threaded rod, the rings can be separated or brought closer. The advantage of this technique is its reproducibility and robustness. The main complications are a) pain during the lengthening because

20 the metal pins cut through the skin to allow distraction between the rings, b) infections of the skin because of prolonged contact with the skin, c) bending of the bone because the newly formed bone is not always of good quality and inflection of the limb can be induced, d) psychological problems with long-term presence of an external metal frame on the arm or leg.

25

With the mechanical lengthening nails, the limb has to be turned 54 times a day, to activate the double gear system in the nail. With the Albizzia nail, the operated bone should be turned to 20° before the gear system is activated. With the ISKD nail, this torsion is reduced to 3°. An advantage of the mechanical systems is that

30 the whole is built into the patient, which would reduce the risk of infection. A disadvantage of the Albizzia is the large turning angle required to activate the gear system. The latter reduces the patients comfort significantly. With the ISKD nail, the turning angle is smaller (3°), but gives a specific disadvantage that the preprogrammed nail may bolt, with the result of a sudden lengthening of several

35 centimeters in one day. This sudden lengthening of the limb can cause paralysis, necrosis of tissue and delayed bone healing. Both nails have the same disadvantage: the nails are straight which make it more difficult to insert the nail in a, by nature, curved bone. The electromotive nail (also referred to as fitbone) has the same advantage as the mechanical lengthening pen; they can be placed entirely internal. Noted as an important disadvantage: rust and withdrawal of the lengthening. In some cases pseudotumors were determined as consequence of this rusting. Besides, the 5 electromotive nail is very restrictive towards patient movement.

Scientific and experimental implants were also described by Gotz & Schellmann however they were never put into practice in: "Continuous lengthening of the femur with intramedullary stabilisation". Archiv. Orthopadische Unfall-Chirurgie 82: 305- 10 310, J.F. Bergmann Publishing. Munich (1975).

WO 2012003555 describes a nail device that can be performed for combined compression/extension, compression only, as a transport nail for transporting an intermediate bone segment or just for lengthening. WO 201200355 has the 15 advantages that the nail device possesses means to limit rotation of the nail device and to limit undesired return of the nail device towards a former position. WO 201200355 shows the disadvantages that the means to limit rotation involve complicated structural measures and that the parts of the nail device external to a patient's body can be considered rather uncomfortably for the patient.

20

The present invention aims to resolve at least some of the problems mentioned above.

SUMMARY OF THE I NVENTION

25

A first aspect of the present invention provides a nail device 1 , 2 for repairing bone defects 26, suitable to be attached to two main bone fragments 3, 4 and extending over a bone defect 26 located between said bone fragments 3, 4, whereby the length of the device 1, 2 between the main bone fragments 3, 4 is able to increase 30 and/or decrease in a hydraulic way, so that new bone tissue in the caused openings can be formed, the nail device 1, 2 comprising:

- a proximal end part 5 comprising one or more proximal locking holes 6 and a hydraulically activatable actuator 22;

- a distal end part 7 provided with an axially extendable nail 8, said nail 8 35 comprising distal locking holes 9;

- a housing 10 extending between said proximal end part 5 and said distal end part 7, said housing 10 comprising an internal bore 11 in which the nail 8 is centrally and axially extendable provided; and - a fluid supply assembly for the supply of hydraulic fluid which is connectable with said proximal end part 5,

wherein said proximal end part 5 comprises a radially oriented socket 33 which is arranged for the mechanically detachable and reversible engagement of said fluid supply assembly.

Such arrangement for the mechanically detachable and reversible engagement of a fluid supply allows for only a limited inconvenience of a patient which is receiving such nail device 1, 2 with fluid supply assembly.

A second aspect of the present invention provides a targeting jig 35 for the installation of a nail device 1 , 2 for repairing bone defects, said targeting jig 35 comprising one or more screw guiding orifices 38 and one or more nail device 1, 2 guiding orifices 36, whereby said targeting jig 35 further comprises one or more guiding orifices 37 for guiding a fluid supply assembly towards said nail device 1 , 2.

Said guiding orifices 37 for guiding said fluid supply assembly enable a minimally invasive installation of said fluid supply assembly into said nail device 1, 2. The use of such guiding orifices 37 reduces the risk of infection and the discomfort of a patient being treated with such nail device 1 , 2 to a minimum.

A third aspect of the present invention provides a kit for the installation of a nail device 1, 2 for repairing bone defects, whereby said kit comprises a nail device 1, 2 and a targeting jig 35.

A fourth aspect of the present invention provides a method for the installation of a nail device 1 , 2 for repairing bone defects 26 within a bone to be repaired, said method comprising the steps of:

- providing a nail device 1, 2 comprising i) a proximal end part 5 comprising one or more proximal locking holes 6 and provided with a hydraulically activatable actuator 22 ii) a distal end part 7 comprising distal locking holes 9 and provided with an axially extendable nail 8, and iii) a housing 10 in between of said proximal end part 5 and distal end part 7, said housing 10 enveloping said nail 8 partially;

- inserting said nail device 1, 2 substantially paralleled with and within bone fragments 3, 4 of said bone to be repaired;

- the application of screws 27 through said proximal 6 and distal locking holes 9; - the application of a fluid supply assembly in fluid connection with said proximal end part 5,

wherein for the application of said fluid supply assembly, said assembly is applied through skin and bone in a radial orientation with regard to and towards said nail device 1, 2.

Said radially oriented application of a fluid supply assembly enables a minimally invasive application of such fluid supply assembly. In this manner, a patient who is receiving said nail device 1, 2 will experience almost no discomfort of the placed fluid supply assembly. Furthermore, such radially oriented application of the fluid supply assembly reduces the risk for infection substantially.

A fifth aspect of the present invention provides a method for adjusting a nail device 1 , 2 for repairing bone defects 26, comprising the steps of:

- providing a nail device 1, 2 comprising i) a proximal end part 5 provided with a hydraulically activatable actuator 22 ii) a distal end part 7 provided with an axially extendable nail 8, iii) a housing 10 in between of said proximal end part 5 and distal end part 7, said housing 10 enveloping said nail 8 partially, and iv) a supply tube 12 in fluid communication with said actuator 22;

- pressurizing said nail device 1 , 2 by administration of a liquid through said supply tube 12 towards said actuator 22.

Pressurization by administering liquid through a supply tube is a convenient and excellently controllable way of adjusting the position of a nail 8 in a nail device 1 , 2.

DESCRI PTI ON OF Fl GURES

Fig. 1 and Fig. 2 show embodiments of a nail device 1, 2 according to the present invention.

Fig.3 and Fig.4 show embodiments of a nail device 1 , 2 attached to two main bone fragments 3, 4, according to the present invention.

Fig. 5 and Fig. 6 show cross sections of embodiments of a nail device 1,2 according to the present invention.

Fig. 7 shows an embodiment of a targeting jig 35 together with a nail device, according to the present invention. Fig. 8 shows an embodiment of a targeting jig 35 for the installation of a nail device, according to the present invention.

Figs. 9a-9b show an embodiment of a targeting jig 35 for the installation of a nail device, according to the present invention.

Fig. 10 shows an embodiment of a nail device, according to the present invention.

Fig. 11 shows an embodiment of a targeting jig 35 together with a nail device, according to the present invention.

Figs. 12-13 show an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, according to the present invention.

Fig. 14 shows an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and drill guides 53, 54, according to the present invention. Fig. 15 shows an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and a first drill guide 53, according to the present invention.

Fig. 16 shows an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and a first drill guide 53 and a drill bit 70, according to the present invention.

Fig. 17 shows an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and a first drill guide 53 and a screwdriver 74, according to the present invention.

Fig. 18 shows an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and a first drill guide 53, according to the present invention.

Figs. 19-20 show an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and a first drill guide 53 and a fluid supply connecting part 17, according to the present invention.

Fig. 21 shows an embodiment of a targeting jig 35 together with a nail device, next to a positioning shaft 45 for positioning of the targeting jig 35 and nail device, and a fluid supply connecting part 17, according to the present invention.

Fig. 22 shows an embodiment of a nail device 1 with a fluid supply connecting part 17, according to the present invention.

DETAI LED DESCRI PTI ON OF THE I NVENTI ON

A first aspect of the present invention provides a nail device 1 , 2 for repairing bone defects 26, suitable to be attached to two main bone fragments 3, 4 and extending over a bone defect 26 located between said bone fragments 3, 4, whereby the length of the device 1, 2 between the main bone fragments 3, 4 is able to increase and/or decrease in a hydraulic way, so that new bone tissue in the caused openings can be formed, the nail device 1, 2 comprising:

- a distal end part 7 provided with an axially extendable nail 8, said nail 8 comprising distal locking holes 9;

- a housing 10 extending between said proximal end part 5 and said distal end part 7, said housing 10 comprising an internal bore 11 in which the nail 8 is centrally and axially extendable provided; and

- a fluid supply assembly for the supply of hydraulic fluid which is connectable with said proximal end part 5,

Such arrangement for the mechanically detachable and reversible engagement of a fluid supply allows for only a limited inconvenience of a patient which is receiving such nail device 1, 2 with fluid supply assembly. Furthermore, this arrangement is not be regarded as obvious as a person skilled in the art, since such person would rather use or optimize the commonly applied procedures for applying a fluid supply device to a nail device 1 , 2 for repairing bone defects 26, such as welding such fluid supply device to such nail device. Said radial orientation of said socket 33 is to be interpreted as any radial orientation along a circle which is oriented perpendicular with respect to a central longitudinal axis 15 throughout said proximal end part 5, with said longitudinal axis 15 being located in the centre of said circle. In preferred embodiments, said socket 33 is a cavity which is suitable for at least partially encompassing said fluid supply assembly and for mechanically detachable and reversible engagement of said fluid supply assembly. In preferred embodiments, said socket 33 is a cavity within said proximal end part 5, which cavity comprises an open side. Said open side is oriented towards the external surface of said proximal end part 5 and is suitable for receiving said fluid supply assembly. In preferred embodiments, said socket 33 is a cavity which extends radially through at least a part of said proximal end part 5. In preferred embodiments, said socket 33 is provided as a truncated-cone-shaped cavity which extends radially through at least a part of said proximal end part 5, with the broad basis of said truncated- cone-shaped cavity being located at the external surface of said proximal end part 5. In preferred embodiments, the engaging end of said fluid supply assembly may comprise an external screw thread while the internal surface of said radially oriented socket 33 comprises a receiving screw thread. This is especially desirable for the detachable engagement of said fluid supply assembly and proximal end part 5, since these structures can be attached or detached by a simple turning motion, which can be performed manually. In other preferred embodiments, said engaging end and said internal surface are provided with a bajonet-type connection arrangement. In other preferred embodiments, said engaging end and said internal surface are provided with a pressure-knob-type connection arrangement. A nail device according to the invention is designed for repairing bone defects 26 between bone fragments. The nail device is suitable for human applications. The device is normally installed in a long bone and is suitable to extend over one or more bone defects 26. In particular, the nail device is applicable for combined bone compression/lengthening, bone compression only, bone transport, or bone lengthening. The length between the main bone fragments can be increased and/or decreased, because the nail 8 can be hydraulically extended out of the housing 10 and/or can be hydraulically retracted towards the housing 10. This is achieved by respectively conducting a pressure increase or decrease in the nail device 1, 2. When this occurs gradually, it is possible for new bone tissue to form in the caused opening. The pressure increase or decrease can occur continuously or preferably discontinuously. By a firm anchoring of the nail device 1 , 2 to main bone fragments with screws 27, this will result locally in marrow extension and subsequently to an extension of the bone. The space formed between main bone fragments is progressively filled with own bone tissue. Initially, the treating doctor takes out the soft marrow tissue in the defect bone by using cutters that can be installed on a flexible support rod system. The bone is taken through and the nail device 1 , 2 is inserted. The nail device 1 , 2 is being connected proximally and distally to the main bone fragments

1 , 2 with screws 27. Through a fluid supply assembly, hydraulic fluid, usually being oil, will be applied to or retracted from the extension nail device 35 to pressurize or depressurize a compartment 32 comprised between the actuator 22 and the nail 8. In the present text, the so-called compartment 32 is referred to as "pressure room" 32. Preferably, the fluid supply assembly is suitable for transport of the hydraulic fluid in a sterile fashion. The fluid supply assembly can go out of the skin of a patient and connect with a hydraulic fluid reservoir which can also be installed internally or externally. For the pressurization and depressurization, an external pump can be used which can transport hydraulic fluid, manually, electronically or by piezoelectric mechanisms, through a fluid supply assembly in the nail device 1,

2. Internally installed fluid reservoirs under pressure, which can in an autonomous way realize a pressure increase or decrease in the pressure room 32, can also be used.

The fluid supply assembly for supplying a hydraulic fluid is preferably in fluid communication with the hydrau lically activatable actuator 22 in the proximal end part 5. In a preferred embodiment, the fluid supply assembly is in fluid communication with the actuator 22 and is removably attached to the proximal end part 5. In a more preferred embodiment, the fluid supply assembly is screwably connected to the proximal end part 5. In this embodiment, it is easy to screw the flexible fluid supply assembly loose from the proximal end part 5. This can be done by turning the fluid supply assembly; there are no additional tools necessary. When placed inside the skin of a patient, local anesthesia is sufficient in preparation of the removal of said fluid supply assembly. When the fluid supply assembly is placed outside the skin of a patient, no anesthesia is required for removal of said fluid supply assembly. In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein said fluid supply assembly comprises a supply tube 12 and a fluid supply connecting part 17 which is provided intermediate to said proximal end part 5 and said supply tube 12, which fluid supply connecting part 17 describes an angle a of 30° to 105° with respect to the general longitudinal orientation of the proximal end part 5. In preferred embodiments, said fluid supply connecting part 17 comprises first 17a and second 17b interconnected parts, the first part 17a being located closer to the proximal end part 5 than the second part 17b, and the first part 17a describing a first angle a of 30° to 105° with respect to the general longitudinal orientation of the proximal end part 5, and the second part 17b describing an angle β of 45° to 135° with respect to the first part 17a. The fluid supply connecting part 17 and the above mentioned orientation of its interconnected parts 17a, 17b offer possibilities to selectively position the supply tube 12 with regard to the proximal end part 5. By changing the dimensions of said first 17a and/or second parts 17b and/or by selecting a specific angle a and/or β within above mentioned limits, the position of the supply tube 12 can be arranged as desired as possible with regard to the body in which it is intended to be installed. In preferred embodiments, said fluid supply connecting part 17 can comprise a synthetic material or a metal. In a preferred embodiment, the fluid supply connecting part 17 comprises a medical approved steel or plastic. In a preferred embodiment, the fluid supply connecting part 17 comprises stainless steel. In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein at least a portion of said internal bore hole 11 and at least a portion of said nail 8 are provided in a non- circular form . The non-circular forms of internal bore hole 11 and nail 8 guarantee full rotation stability for the axially extendable nail 8. Axial rotation of the nail 8 will therefore be absent when extending the nail 8, entailing the advantages that i) the formation of new bone tissue is left largely undisturbed during nail 8 extension, ii) the risk of infection is decreased, and iii) the discomfort of a patient being treated with such nail 8 is reduced substantially. An absence or deficit of rotational stability of the nail 8 in a nail device 1 , 2 is unwanted for the treatment of a patient with such device 1, 2. The present invention overcomes this problem by providing both nail 8 and the internal bore hole 11 of the housing 10 comprising said nail 8 at least partially in a non-circular form. Providing said internal bore hole 11 and said nail 8 in a non- circular form, in order to guarantee full rotation stability of the nail 8, would not be evident to devise by a person skilled in the art, since such a skilled person would rather employ external means for restriction of the nail 8 instead of modifying the essential structural parts of the housing 10 and nail 8. The nail 8 can comprise a synthetic material or a metal. In a preferred embodiment, the nail 10 comprises a medical approved steel or plastic. In a preferred embodiment, the nail 10 comprises cobalt chrome steel. The housing 10 can be provided in a cylindrical shape, rectangular shape, or any other shape suited for installation in a bone. In a preferred embodiment, the housing 10 is provided as a cylindrical shape. The housing can comprise a synthetic material or a metal. In a preferred embodiment, the housing 10 comprises a medical approved steel or plastic. In a preferred embodiment, the housing comprises cobalt chrome steel.

The internal bore hole 11 is suited for enclosing the nail 8 at least partially. The non-circular forms of said internal bore hole 11 and said nail 8 can be selected from any conceivable non-circular forms, such as, but not limited to triangular, rectangular and hexagonal forms. Preferably, the selected non-circular form for the internal bore hole 11 is identical to the selected non-circular form of the nail 8, since this will contribute to the rotation stability of the nail 8 in the housing 10.

In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein said nail 8 is provided in sealingly contact within said internal bore hole 11.

This measure further increases the rotational stability of the nail 8 within the housing 10.

In a preferred embodiment, the present invention provides a nail device 1 according to the first aspect of the invention, wherein the proximal end part 5 comprises a fluid socket 14 intermediate to said actuator 22 and said fluid supply assembly, said fluid socket 14 being 360° rotatable around a central longitudinal axis 15 through said socket 14.

Rotation of said fluid socket 14 around said axis 15 changes the position of the supply tube 14 relative to the nail device 1. Accordingly, the position of the supply tube 14 can be oriented in such a way that the hindrance of said tube 14 to one or more body parts of a patient, and to the movement of such body parts, is reduced to a minimum. In a preferred embodiment, the present invention provides a nail device 1 according to the first aspect of the invention, comprising releasable fixing means 16 for fixation of said rotatable fluid socket 14. Said fixing means 16 allow for fixation of said rotatable fluid socket 14. As a result, said fixing means 15 also allow for fixation of the position of the supply tube 12. Re-positioning of said fluid socket 14 and supply tube 12 is possible since the fixing means 15 are releasable. Any suitable releasable fixing means 16 as known in the prior art can be selected. In a preferred embodiment, a screw-type connection is selected as releasable fixing means 16.

In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein a first check valve 19 is provided between said supply tube 12 and said proximal end part 5.

The first check valve 19 blocks and thus prevents the backflow of hydraulic fluid from the proximal end part 5 to the supply tube 12.

In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein said hydraulically activatable actuator 22 is provided with a second check valve 21.

The second check valve 21 blocks and thus prevents the backflow of hydraulic fluid towards the actuator 22.

In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein the part of the internal bore hole 11 of the housing 10 adjacent to the proximal end part 5 comprises a pressure room 32 sealed by a piston 20, wherein the piston 20 sealingly contacts said internal bore hole 11. Generally, the proximal end part 5 can comprise a synthetic material or a metal. In a preferred embodiment, the proximal end part 5 comprises a medical approved steel or plastic. In a preferred embodiment, the proximal end part 5 comprises stainless steel.

A perfect sealing between the internal bore hole 11 and the piston 20 is of great importance to maintain the pressure which is built up proximally of the piston 20. In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein the supply tube 12 comprises a rigid and/or flexible material. A supply tube 12 comprising a rigid material shows a reduced risk of entanglement compared to a tube in a less rigid material. Furthermore, a supply tube 12 comprising a rigid material has a limited freedom of movement, which is considered beneficial for the ease of movement of a patient's body part bearing a nail device 1, 2 according to the present invention. Suitable rigid materials include, yet are not limited to, metals, alloys, hard plastics, and plastics reinforced with steel wire. In other embodiments, said supply tube 12 comprises a flexible material. A flexible supply tube 12 shows a high ease of installation and can be preferred when the movement of a patient's body is not a priority, such as for disabled or bedridden persons.

In a preferred embodiment, the present invention provides a nail device 1, 2 according to the first aspect of the invention, wherein the hydraulic fluid comprises a non-synthetic, non-crude oil. Non-synthetic, non-crude oils, like plant oils, are readily available, renewable and environmentally friendly. Moreover, such oils present a very low risk of infection.

In a preferred embodiment, the present invention provides a targeting jig 35 according to the second aspect of the invention, wherein said targeting jig 35 is arranged for the mechanically detachable and reversible engagement of said nail device 1, 2. In such way, said nail device 1, 2 can be thoroughly guided by means of said jig 35. In preferred embodiments, at the position of said jig 35 which is arranged for the mechanically detachable and reversible engagement of said nail device 1, 2, said jig 35 is provided with a structure with a shape which is the negative of the shape of said nail device 1, 2 which is to be engaged. In preferred embodiments, the parts of said jig 35 and said nail device 1, 2 which are to be engaged in a mechanically detachable and reversible manner are provided with a bajonet-type or pressure-knob-type connection arrangement. In other preferred embodiments, the parts of said jig 35 and said nail device 1, 2 which are to be engaged in a mechanically detachable and reversible manner are provided with a screw tread connection arrangement.

In a preferred embodiment, the present invention provides a targeting jig 35 according to the second aspect of the invention, wherein said one or more screw guiding orifices 38 and said one or more guiding orifices 37 for guiding said fluid supply assembly have a parallel orientation with regard to each other, with one or more axes 41 running through each of one or more of said screw guiding orifices 38 being parallel with one or more axes 40 running through each of one or more of said guiding orifices 37 for guiding said fluid supply assembly. Said parallel orientations according to said axes 40, 41 allow easy placement of screws 27 and/or fluid supply assembly through said orifices 37, 38. Furthermore, said orientations according to said axes 40, 41 are compatible with a nail device 1, 2 comprising parallel oriented receiving structures for receiving said screws 27 and/or fluid supply assembly.

In a preferred embodiment, the present invention provides a targeting jig 35 according to the second aspect of the invention, wherein, with regard to the orientation of a nail device 1, 2 which is guidable by said jig 35, two screw guiding orifices 38 are located more distally in said jig 35 than one guiding orifice 37 for guiding said fluid supply assembly in said jig 35. In this way, said nail device 1, 2 can efficiently be provided with two screws 27 for firmly locking said nail device 1, 2 within a bone along bone defects 26 while said fluid supply assembly can be attached to a more proximally located part of said nail device 1 , 2.

In a preferred embodiment, the present invention provides a targeting jig 35 according to the second aspect of the invention, wherein the nail device 1 , 2 is a nail device 1 , 2 according to the first aspect of the present invention.

A third aspect of the present invention provides a kit for the installation of a nail device 1, 2 for repairing bone defects, whereby said kit comprises a nail device 1, 2 and a targeting jig 35. In a preferred embodiment, the present invention provides a kit according to the third aspect of the invention, wherein said kit comprises a nail device 1, 2 according to the first aspect of the present invention and/or a targeting jig 35 according to the second aspect of the present invention.

A fourth aspect of the present invention provides a method for the installation of a nail device 1, 2 for repairing bone defects 26 within a bone to be repaired, said method comprising the steps of:

- the application of screws 27 through said proximal 6 and distal locking holes 9;

- the application of a fluid supply assembly in fluid connection with said proximal end part 5,

In a preferred embodiment, the present invention provides a method according to the fourth aspect of the invention, wherein said fluid supply assembly is guided through a guiding orifice 37 of a targeting jig 35 according to the second aspect of the present invention. The use of said targeting jig 35 ensures a well-directed and optimally guided application of a fluid supply assembly into said nail device 1, 2. A fifth aspect of the present invention provides a method for adjusting a nail device 1 , 2 for repairing bone defects 26, comprising the steps of:

- providing a nail device 1, 2 comprising i) a proximal end part 5 provided with a hydraulically activatable actuator 22 ii) a distal end part 7 provided with an

5 axially extendable nail 8, iii) a housing 10 in between of said proximal end part 5 and distal end part 7, said housing 10 enveloping said nail 8 partially, and iv) a supply tube 12 in fluid communication with said actuator 22;

10

Pressurization by administering liquid in a nail device 1 , 2 for repairing bone defects 15 26 would not readily be considered by a person skilled in the art, since it is generally thought that the liquid could pose risks of infection. This risks are however exaggerated and are in fact virtually non-existent, since infection by a liquid can be prevented by using safe liquids and by including safety mechanisms, such as check valves 19, 21 , in the nail device 1 , 2.

20

In a preferred embodiment, the present invention provides a method according to the fifth aspect of the invention, further comprising the step of rotating at least a part of said proximal end part 5 by an angle of 0° to 360° around a central longitudinal axis 15 through said part 5.

25

By rotating the proximal end part 5, the orientation of the supply tube 12 can be changed. This could be desired for alleviating structural hindrance affected by said supply tube 12.

30 In a preferred embodiment, the present invention provides a method according to the fifth aspect of the invention, wherein said nail device 1 , 2 is pressurized by said liquid at a pressure level of 1 MPa to 25 MPa.

The mentioned pressure levels are ideally fitted to pressurize and consequently 35 move a nail 8 of a nail device 1, 2, and especially for movement of said nail 8 against an external force. For the purpose of moving the nail 8, said nail device 1 , 2 is pressurized by said liquid at a pressure level of 2 MPa to 16 MPa in a more preferred embodiment. In an even more preferred embodiment, said nail device 1, 2 is pressurized by said liquid at a pressure level of 3 MPa to 6 MPa.

EXAMPLES

Specific embodiments of the invention are presented in Figs. 1 to 8. Fig. 1 and Fig. 2 show two different embodiments of a nail device 1, 2. Fig. 3 and Fig. 4 show two different embodiments of a nail device 1, 2, each attached to two main bone fragments 3, 4. Fig. 5 and Fig. 6 show cross sections of two different embodiments of a nail device 1, 2. Fig. 7 shows an embodiment of a targeting jig 35 together with a nail device 1, 2. Fig. 8 shows an embodiment of a targeting jig 35 for the installation of a nail device 1, 2. In the embodiments of the nail device 1, 2 presented in the Figs., the nail device 1, 2 comprises a fluid supply assembly which comprises a supply tube 12 connected to a fluid supply connecting part 17 through a connection piece 18.

Fig. 1 , Fig.3 and Fig. 5 show a nail device 1 with a 360° rotatable fluid socket 14 at the proximal side of the proximal end part 5. The fluid socket 14 is connected to a fluid supply connecting part 17 which in its turn is connected to a supply tube 12 through a connection piece 18, preferably a connection piece 18 comprising stainless steel. The position of the supply tube 12 can be adjusted by rotation of the fluid socket 14 around a central longitudinal axis 15 through said socket 14. The orientation of the fluid socket 14 can be fixed by a screw 16 for tightening the socket 14. Loosening of said screw 16 allows for re-adjustment of the orientation of the socket 14. Fig. 2, Fig. 4 and Fig. 6 show a nail device 2 without such rotatable fluid socket 14. Instead, a cap 31 closing of the proximal end part 5 is provided. While lacking the ability of adjusting the position of the supply tube 12 by a rotational movement around a central longitudinal axis 15, the configuration without a rotatable fluid socket 14 can be preferred in situations where providing such a socket 14 would be difficult due to structural limitations. The nail device 1 shown in Fig. 1, Fig.3 and Fig. 5 is especially fit for implementation in the femur or thigh bone of a patient. The nail device 2 shown in Fig. 2, Fig. 4 and Fig. 6 is especially suited for implementation in the tibia or shinbone of a patient. The positioning of the different parts of the two different embodiments of a nail device 1 , 2 are clearly shown in the cross sections in Fig. 5 and Fig. 6. The proximal part 5 is connected to the housing 10 by a screw connection 25. The nail 8 is provided in sealingly contact within the internal bore hole 11 of the housing 10. Furthermore, both the internal bore hole 11 and the nail 8 are provided in a non- circular form, thereby ruling out rotational movement of the nail 8. Proximally to the nail 8, a piston 20 is provided in sealingly contact within the bore hole 11. The space within the bore hole 11 that is confined by the piston 20 on the one side and the screw connection 25 to the proximal end part 5 on the other side, forms a pressure room 32. The distal end part 7, located distally from the housing 10, equals the part of the nail 8 that is not covered by the housing 10. Besides the rotatable fluid socket 14 and screw 16 of one embodiment and the cap 31 of the other embodiment, the proximal end part 5 comprises a hydrau lically activatable actuator 22 in fluid connection with the connection part 17, which is in its turn in fluid connection with a connection piece 18, the latter which is in fluid connection with the supply tube 12. The supply tube 12 is specifically connected to the connection piece 18 by a screw connection 30. This means that the supply tube 12 is removably attached to the connection piece 18. The supply tube 12 can thus be disconnected when desired. The fluid supply connecting part 17 comprises first 17a and second 17b interconnected parts, the first part 17a being located closer to the proximal end part 5 than the second part 17b, and the first part 17a describing a first angle a of with respect to the general longitudinal orientation of the proximal end part 5, and the second part 17b describing an angle β with respect to the first part 17a. In the specific embodiment presented in Fig. 5, the proximal side of the actuator 22 is connected to the fluid socket 14 by a screw connection 29. For both the embodiments presented in Fig. 5 and Fig 6, the distal side of the actuator 22 is connected to a fluid transport part 23 by a screw connection 24. A fluid channel 28 runs through the actuator 22 and the fluid transport part 23, and eventually exits through the screw connection 25 between the proximal end part 5 and the housing 10. This fluid channel 28 is suited to receive fluid from the supply tube 12 at level of the channel's 28 proximal part and to deliver fluid to the pressure room 32 at level of the channel's 28 distal part. The check valve 21 located in the transition between the actuator 22 and the fluid transport part 23 hinders the backflow of liquid towards the actuator 22. In the connection piece, another check valve 19 is present for preventing the backflow of fluid from the proximal end part 5 to the supply tube 12. The two check valves 19, 21 thus deliver a double protection against backflow of liquid. Fig. 3 and Fig. 4 show the two different embodiments of the nail device 1, 2, each attached to two main bone fragments 3, 4. The nail devices 1 , 2 both extend over a bone defect 26 and are connected to the first bone fragment 3 by screws 27 through proximal locking holes 6 and to the second bone fragment 3 by screws 27 through distal locking holes 9. By delivering fluid through the supply tube 12, pressure can be build up in the pressure room 32, which will cause extension of the nail 8. This is for example desired for bone lengthening applications.

Fig. 7 shows schematically the placement of a nail device 1, 2 into a bone along a bone defect 26 with use of a targeting jig 35. For reasons of clarity, the bone was withheld from the presentation of Fig. 7. Firstly, said jig 35 comprises a nail device 1, 2 guiding orifice 36, which is arranged to guide said nail device 1, 2 throughout a bore in a bone along a bone defect 26, along a direction 39 parallel to said bone. Secondly, said jig 35 comprises screw 27 guiding orifices 38 for guiding screws 27 into locking holes 6 of the nail device 1, 2, along a direction 41 which is radially oriented with respect to said nail device 1, 2. Thirdly, said jig 35 comprises a guiding orifice 37 for guiding a fluid supply assembly towards said nail device 1, 2. Said latter guiding orifice 37 allows for guiding a fluid supply assembly towards said nail device 1, 2 in a direction 40 which is radially oriented with respect to said nail device 1, 2. In the specific embodiment shown in Fig. 7, the fluid supply connecting part 17 of a fluid supply assembly (part of fluid supply assembly is not shown in Fig. 7) is guided towards a radially oriented socket 33 within the proximal end part 5 of said nail device 1, 2. For connection purposes, the engaging end 34 of said fluid supply connecting part 17 and the internal surface of said radially oriented socket 33 are provided with a bajonet-type connection arrangement.

An additional preferred embodiment of the invention is presented in Figs. 9a to 22. This embodiment relates to a nail device 1 for repairing bone defects 26, with a targeting jig 35 for placement of such nail device, and a positioning shaft 45 for easy and precise positioning of the whole of said targeting jig 35 and nail device. In Figs. 9a and Fig. 9b it is shown clearly that the targeting jig 35 according to this embodiment comprises a transverse slot 42, forming a transversely directed opening of a guiding orifice 37 of the targeting jig 35 towards an environment. Such transverse slot 42 is a well-thought means for easy and clean instalment of a nail device 1 with a fluid supply connecting part 17 along one or more bone defects 26. Additionally, said targeting jig 35 comprises two tantalum pins 43, located closely to where the targeting jig 35 is able to contact a cap 31 of a nail device. Fig. 10 shows a nail device according to this embodiment with a screwcap 44 which is reversibly screwed into a radially oriented socket 33 within the proximal end part 5 of said nail device. Said screwcap 44 comprises an external right thread of metric M5 and an internal left thread of metric M3. Such external and internal threads facilitate easy attachment and detachment of said screwcap 44 into or out of said radially oriented socket 33. Additionally, said nail device comprises multiple tantalum pins 80 onto an axially extendable nail 8 of said nail device (of which two pins 80 are visible in Fig. 10) and close to a distal end part 7 of said nail device. The distance between said tantalum pins 80 onto said axially extendable nail 8 is 1 cm. However, other distances may be chosen. Said tantalum pins 43, 80 are helpful for localizing said jig 35 by imaging methods. Any other material other than tantalum which may be used for localization by imaging methods may be used. Yet, tantalum is preferred.

Fig. 11 shows the targeting jig 35 which is connected to the nail device 1. Fig. 12 shows the same configuration as in Fig. 11, with the difference that a positioning shaft 45 is shown next to the targeting jig 35. The positioning shaft is intended for easy and precise positioning of the targeting jig 35 and nail device 1. A mounting end section 46 of said positioning shaft 45 is suited for reversibly engaging said targeting jig 35 and nail device 1. The mounding end section 46 is an end of a first cylindrical part 47 of the positioning shaft 45, located next to an engaging portion 48 of the positioning shaft 45. Oppositely to the first cylindrical part 47 and next to said engaging portion, a second cylindrical part 52 of the positioning shaft 45 is located. The engaging portion 48 is intended for easy and firm grasping of said positioning shaft by external grasping means. For easy and firm grasping, the engaging portion comprises ribs 49, notches 50 and openings 51. In Fig. 13, a configuration is shown wherein said positioning shaft 45 is reversibly connected to said targeting jig 35. In Fig. 14, it is shown that an assembly of first 53 and second hollow drill guides 54 are situated within a guiding orifice 37 of the targeting jig 35. The first hollow drill guide 53 comprises an engaging portion 55 intended for engagement with an engaging tool or by hand, ribs 56 and notches 57 for simplifying said engagement, a cylindrical shaft 58 in extension of the engaging portion 55, a screw-thread 59 of the cylindrical shaft 58 for reversibly and screwably attachment of said first drill guide 53 in the guiding orifice 37 of the targeting jig 35, a cavity 60 throughout the first drill guide 53 for receiving a cylindrical shaft 66 of the second drill guide 54, a first opening 61 for receiving a cylindrical shaft 66 of the second drill guide 54, and a second opening 62 located oppositely with regard to said first opening 61. The second hollow drill guide 54 comprises an engaging portion 63 intended for engagement with an engaging tool or by hand, ribs 64 and notches 65 for simplifying said engagement, a cylindrical shaft 66 in extension of the engaging portion 63, a screw-thread 67 of the cylindrical shaft 66 for reversibly and screwably attachment of said second drill guide 54 in a cavity 60 which runs throughout the first drill guide 53, thus for connecting first 53 and second drill guides 54, and an end section 68 of the cylindrical shaft 66, which end section 68 ends in a point-shaped end 69. As shown in Fig. 14, the second drill guide 54 is reversibly connected to the first drill guide by said screw-thread 67 of the second drill guide 54 which is reversibly connected to said cavity 60 of said first drill guide 53. On its turn, said first drill guide 53 is 5 reversibly connected to the targeting jig 35 by said screw-thread 59 of the first drill guide 53 which is reversibly connected to the guiding orifice 37 of the targeting jig 35. The end section 68 of the cylindrical shaft 66 of the second drill guide 54 extends beyond the cylindrical shaft 58 of the first drill guide 53 in this configuration, enabling a configuration of first 53 and second drill guides 54 which 10 is closed from the environment, thus preventing the risk of spoiling the cavity 60 which runs throughout the first drill guide 53. This is helpful to reduce the risk of infection when using this embodiment of the invention for repairing bone defects 26.

15 Fig. 15 shows the configuration of Fig. 14, yet with second drill guide 54 removed from the first drill guide 53, resulting in the cavity 60 of the first drill guide 53 being in contact with the environment. This enables the insertion of a drill bit 70 (Fig. 16), comprising an engaging portion 71 and drill head 72 ending in a drill thread 73, into said cavity, with said drill head 72 directed to said second opening

20 62 of the first drill guide 53. This enables the formation of a passageway from said cavity 60 towards the radially oriented socket within the proximal end part 5 of said nail device, when using this embodiment of the invention for repairing bone defects 26.

25 Fig. 17 shows a screwdriver 74, comprising a handle 75, cylindrical shaft 76 and screwhead 77, which is directed with its screwhead 77 towards the screwcap 44 which is reversibly screwed into a radially oriented socket 33 within the proximal end part 5 of said nail device 1. Accordingly, said screwcap 44 may be removed from said radially oriented socket 33 when using this embodiment of the invention

30 for repairing bone defects 26.

Fig. 18 shows a configuration wherein said screwcap 44 is removed from said radially oriented socket 33, and wherein the first drill guide 53 is still inserted into the guiding orifice 37 of the targeting jig 35. In Fig. 19, an engaging end 34 of a 35 fluid supply connecting part 17 is present inside said cavity 60 of the first drill guide 53 and directed towards said radially oriented socket 33. Said cavity 60 of the first drill guide 53 allows precise and easy reversible connection of said engaging end 34 inside said radially oriented socket 33, of which a reversibly connected configuration is shown in Fig. 20. As a next step, it is very easy to remove the first drill guide 53, while maintaining the reversible connection of fluid supply connecting part 17 and nail device 1 (Fig. 21). Furthermore, with a simple rotating motion of said positioning shaft 45 (take notice of the arrow drawn in Fig.21), the positioning shaft 45 can be loosened, allowing the jig 35 to be moved away, resulting in the configuration shown in Fig. 22. This configuration shown in Fig. 22 is especially suited when using the nail device 1 of the present invention according to this embodiment for repairing bone defects 26, with optimal precision of installing the nail device 1 and minimum risk of infection.

Claims

CLAI MS

A nail device (1, 2) for repairing bone defects (26), suitable to be attached to two main bone fragments (3, 4) and extending over a bone defect (26) located between said bone fragments (3, 4), whereby the length of the device (1, 2) between the main bone fragments (3,

4) is able to increase and/or decrease in a hydraulic way, so that new bone tissue in the caused openings can be formed, the nail device (1, 2) comprising:

- a proximal end part (5) comprising one or more proximal locking holes (6) and a hydrau lically activatable actuator (22);

- a distal end part (7) provided with an axially extendable nail (8), said nail (8) comprising distal locking holes (9);

- a housing (10) extending between said proximal end part (5) and said distal end part (7), said housing (10) comprising an internal bore (11) in which the nail (8) is centrally and axially extendable provided; and

- a fluid supply assembly for the supply of hydraulic fluid which is connectable with said proximal end part (5),

whereby said proximal end part (5) comprises a radially oriented socket (33) which is arranged for the mechanically detachable and reversible engagement of said fluid supply assembly.

Nail device (1, 2) according to claim 1, wherein said fluid supply assembly comprises a supply tube (12) and a fluid supply connecting part (17) which is provided intermediate to said proximal end part (5) and said supply tube (12), which fluid supply connecting part (17) describes an angle a of 30° to 105° with respect to the general longitudinal orientation of the proximal end part (5).

Nail device (1, 2) according to claim 1 or 2, wherein at least a portion of said internal bore hole (11) and at least a portion of said nail (8) are provided in a non-circular form .

Nail device (1, 2) according to any one of the preceding claims, wherein said nail (8) is provided in sealingly contact within said internal bore hole (11).

Nail device (1) according to any one of the preceding claims, wherein the proximal end part

(5) comprises a fluid socket (14) intermediate to said actuator (22) and said fluid supply assembly, said fluid socket (14) being 360° rotatable around a central longitudinal axis (15) through said socket (14).

6. Nail device (1) according to claim 5, comprising releasable fixing means (16) for fixation of said rotatable fluid socket (14).

7. Nail device (1, 2) according to any one of the claims 2 to 6, wherein a first check valve (19) is provided between said supply tube (12) and said proximal end part (5).

8. Nail device (1, 2) according to any one of the preceding claims, wherein said hydraulically activatable actuator (22) is provided with a second check valve (21).

9. Nail device (1, 2) according to any one of the preceding claims, wherein the part of the internal bore hole (11) of the housing (10) adjacent to the proximal end part (5) comprises a pressure room (32) sealed by a piston (20), wherein the piston (20) sealingly contacts said internal bore hole (11).

10. Nail device (1, 2) according to any one of the claims 2 to 9, wherein the supply tube (12) comprises a rigid and/or flexible material.

11. Nail device (1, 2) according to any one of the preceding claims, wherein the hydraulic fluid comprises a non-synthetic, non-crude oil.

12. Targeting jig (35) for the installation of a nail device (1, 2) for repairing bone defects, said targeting jig (35) comprising one or more screw guiding orifices (38) and one or more nail device (1, 2) guiding orifices (36), characterised in that said targeting jig (35) further comprises one or more guiding orifices (37) for guiding a fluid supply assembly towards said nail device (1 , 2).

13. Targeting jig (35) according to claim 12, wherein said targeting jig (35) is arranged for the mechanically detachable and reversible engagement of said nail device (1 , 2).

14. Targeting jig (35) according to claim 12 or 13, wherein said one or more screw guiding orifices (38) and said one or more guiding orifices (37) for guiding said fluid supply assembly have a parallel orientation with regard to each other, with one or more axes (41) running through each of one or more of said screw guiding orifices (38) being parallel with one or more axes (40) running through each of one or more of said guiding orifices (37) for guiding said fluid supply assembly.

15. Targeting jig (35) according to claim 14, wherein, with regard to the orientation of a nail device (1, 2) which is guidable by said jig (35), two screw guiding orifices (38) are located more distally in said jig (35) than one guiding orifice (37) for guiding said fluid supply assembly in said jig (35).

16. Targeting jig (35) according to any one of the claims 12 to 15, wherein the nail device (1, 2) is a nail device (1, 2) according to any one of the claims 1 to 11.

17. Kit for the installation of a nail device (1, 2) for repairing bone defects, characterised in that said kit comprises a nail device (1, 2) and a targeting jig (35).

18. Kit according to claim 17, wherein said kit comprises a nail device (1, 2) according to any one of the claims 1 to 11 and/or a targeting jig (35) according to any one of the claims 12 to 16.

19. Method for the installation of a nail device (1, 2) for repairing bone defects (26) within a bone to be repaired, said method comprising the steps of: providing a nail device 1, 2 comprising i) a proximal end part 5 comprising one or more proximal locking holes 6 and provided with a hydraulically activatable actuator 22 ii) a distal end part 7 comprising distal locking holes 9 and provided with an axially extendable nail 8, and iii) a housing 10 in between of said proximal end part 5 and distal end part 7, said housing 10 enveloping said nail 8 partially;

inserting said nail device 1, 2 substantially paralleled with and within bone fragments 3, 4 of said bone to be repaired;

the application of screws 27 through said proximal 6 and distal locking holes 9;

the application of a fluid supply assembly in fluid connection with said proximal end part 5, characterised in that for the application of said fluid supply assembly, said assembly is applied through skin and bone in a radial orientation with regard to and towards said nail device 1 , 2.

20. Method according to claim 19, wherein said fluid supply assembly is guided through a guiding orifice (37) of a targeting jig (35) according to any one of the claims 12 to 16.

21. Method for adjusting a nail device (1, 2) for repairing bone defects (26), comprising the steps of:

- providing a nail device (1, 2) comprising i) a proximal end part (5) provided with a hydrau lically activatable actuator (22) ii) a distal end part (7) provided with an axially extendable nail (8), iii) a housing (10) in between of said proximal end part (5) and distal end part (7), said housing (10) enveloping said nail (8) partially, and iv) a supply tube (12) in fluid communication with said actuator (22);

- pressurizing said nail device (1, 2) by administration of a liquid through said supply tube (12) towards said actuator (22).

22. Method according to claim 21, further comprising the step of rotating at least a part of said proximal end part (5) by an angle of 0° to 360° around a central longitudinal axis (15) through said part (5).

23. Method according to claim 21 or 22, wherein said nail device (1, 2) is pressurized by said liquid at a pressure level of 1 MPa to 25 MPa.

24. Method according to any one of the claims 21 to 23, wherein said nail device (1, 2) is a nail device (1, 2) according to any one of the claims 1 to 11.