The present disclosure relates to a targeting guide to be used in the internal fixation for fractured long bones. Such targeting guides facilitate a correct insertion and alignment of an implant or implant system that serves to stabilize the bone. In particular, said guides foster an assembly of implant systems which are composed of more than one component. Moreover, targeting guides are also used in many cases during preparation of the bone prior to insertion of the implant or implant system or components thereof.

EP 1 344 494 A2 discloses a targeting guide comprising a targeting arm that has a circular cross-section and that is provided with a plurality of first guide passages to receive and guide a tool during surgery. Said targeting arm carries coaxially a sleeve comprising a plurality of second guide passages. Said sleeve is rotatable with respect to said targeting arm and can assume predefined rotational positions. In each of said predefined positions one of said second guide passages is aligned with one of said first guide passages.

Here, a novel targeting guide is suggested that supports a reliable and easy preparation of the bone and/or insertion, alignment and/or assembly of an implant or implant system.

The targeting guide according to claim 1 is provided with an arm which is adapted and configured to be connected to an implant which is adapted and configured to be inserted into a fractured long bone. Further, the targeting guide comprises a first guide member and a second guide member being arranged one inside the other and being displaceable with respect to each other - e.g. by a rotation or a linear relative movement of the first and/ or second guide members - in a displacement direction between a release configuration and a locking configuration. The first guide member is connected to the arm such as to be immobile with respect to the arm. A first guide passage is formed in the first guide member and a second guide passage is formed in the second guide member, the guide passages being adapted and configured to receive a tool and/ or a tool guide, wherein in the release configuration the guide passages are aligned and define an alignment axis along which the tool or tool guide is freely movable with respect to the guide members, and wherein in the locking configuration the guide passages are misaligned and/ or offset such as to clamp the tool or tool guide received in the guide passages. The targeting guide further comprises an actuation mechanism adapted and configured to displace the guide members with respect to each other between the release configuration and the locking

configuration.

Clamping of the tool or the tool guide to the first and second guide members allows - inter alia - temporarily interrupting the process of preparing the bone and/or inserting, aligning or assembling the implant or the implant system if necessary without compromising the success of the surgery, since e.g. specifically selected geometrical settings of the components involved are reliably preserved. As mentioned above, the first guide member is connected to the arm.

Further, the second guide member is received within the first guide member. Thus, the with respect to the arm immobile first guide member shields the e.g. barrel-like and thus compact mobile second guide member to avoid misuse and/or unintentional manipulation. Further, receiving the mobile second guide member within the immobile first guide member allows adapting the outer geometry of the immobile first member freely without being restricted by shape requirements that can be associated with guidance, activation and/ or selection features disposed on the mobile second guide member. Thus, the outer geometry of the first guide member is largely independent from the geometry of the second guide member. In particular, it is not necessary to provide the first guide member with a rotational symmetric cross-section. The first guide member may be shaped such that - in addition to the at least one first guide passage - further functional elements may be provided. The cross-section of the first guide member may be e.g. oblong, in particular in essence oval or rectangular.

The functional elements mentioned above may be openings that receive accessory components, such as stabilization pins that help to establish and/or to maintain a well-defined orientation of bone components that are to be fixed to the fractured long bone during implantation. E.g. these pins are inserted into the head of a femur that has to be fixed to the femur by an implant or implant system. The orientations of the corresponding openings on the first guide member can be chosen such that pins disposed therein penetrate the head obliquely in order to reliably hold the head in the correct anatomical position during insertion of the tool or the implant into the head of the femur.

Additionally or alternatively, one or more openings may be provided that can be used to guide a tool, a tool guide or an implant component - such as a screw - to distally lock the implant in the bone.

Said functional elements such as the various openings mentioned above can be disposed off-centered with respect to a central axis of the first guide member and/or second guide member. In particular, said openings do not intersect said central axis. More particularly, the functional elements, in particular the various openings discussed above, do not intersect or touch the second guide member or an opening or cavity of the first guide member receiving the second guide member.

Further, the first guide member can be provided with relatively large markings that ensure a reliable use of the targeting guide without being obstructed by the movable second guide member. In other words, the concept of an immobile first guide member receiving the mobile second guide member is associated with a great degree of freedom in shaping the first guide member. E.g. the first guide member may have a minimalistic design just providing enough volume to receive the second guide member. However, it is also conceivable to provide the first guide member with a geometric shape and sufficient volume to accommodate further functional elements and features.

According to an embodiment of the targeting guide, the guide passages are coaxially aligned with each other in the release configuration of the guide members, so as to allow the passage of the tool or the tool guide without hindrance.

In another embodiment of the targeting guide, the guide passages are - at least partially - overlapping each other when viewed along the alignment axis in the locking configuration of the guide members. In other words, the guide passages do not fall exactly in line in this configuration but their contours intersect to achieve the desired clamping effect.

In yet another embodiment of the targeting guide, the guide members are movable with respect to each other exclusively in the displacement direction, in particular along a linear displacement axis. In other words, the degree of freedom as regards a relative movement of the guide members is limited to the displacement direction in order to minimize the risk of inadvertent misuse of the targeting guide. In particular, the guide members are displaceable with respect to each other along a linear displacement axis. However, it is also feasible to allow a relative rotational displacement.

According to another embodiment, the guide member which is connected to the arm is formed integrally with the arm such that the guide member and the arm are made in one piece. Exemplarily, the first guide member is a housing arranged over the second guide member. The second guide member may be a barrel.

In yet another embodiment, the guide passages are a first pair of guide passages and the alignment axis defined by the first pair of guide

passages in the release configuration is a first alignment axis, and wherein the guide members have at least one second pair of guide passages which in the release configuration define a second alignment axis, the second alignment axis being non-parallel to the first alignment axis. Providing the first and second alignment axis allows using the targeting guide with different implants that are optimized for different anatomical situations.

According to a simple yet effective embodiment, the guide passages are guide bores.

According to another embodiment of the targeting guide, the actuation mechanism comprises an actuation member connected to one guide member and a transfer mechanism coupling the actuation member to the other guide member to selectively control the displacement of the guide members. Exemplarily, the actuation member is fixedly connected to the guide member with respect to the displacement direction. The transfer mechanism may be adapted and configured to transfer an actuation movement of the actuation member into a displacement of the guide members with respect to each other in the displacement direction between the release configuration and the locking configuration.

According to a further embodiment, the actuation movement of the actuation member is a rotational actuation movement. In particular, the transfer mechanism is adapted and configured to transfer a rotational actuation movement of the actuation member into a linear displacement of the guide members with respect to each other along a linear displacement axis. By way of example, the relative displacement of the guide members is achieved if the transfer mechanism couples the actuation member to the guide member which is connected to the arm. The transfer mechanism comprises in particular a restraint for coupling the actuation member to the other guide member. A restraint in that sense comprises e.g. a ramp- mechanism, a cam/cam-follower-combination, a threaded coupling or a male/female arrangement. It is also conceivable that the restraint comprises at least one pin-slot-arrangement having a pin and a slot, the pin being guided in the slot and the slot extending, in particular by less than 180°, in particular by less than 90°, as a helical segment around a linear displacement axis, such that moving the pin along the slot causes the pin to move or to be displaced along the displacement axis.

In an embodiment, the pin-slot-arrangement comprises two symmetrically arranged slots for the pin, each of the two slots extending, in particular by less than 180°, in particular by less than 90°, as a helical segment around the linear displacement axis, the two helical segments starting from a common point in the same direction as viewed along the linear

displacement axis. Thus, in this embodiment the direction of displacement effected by rotating the actuation member is independent on the rotational direction of the actuation member, thereby making the use of the

actuation mechanism easier. In other words, the actuation member can be rotated either clockwise or anti-clockwise, thereby in both cases effecting a displacement in the same linear direction.

In particular, the pin is connected to the actuation member and the slot is formed in the guide member, or vice versa.

According to another embodiment of the targeting guide, the guide member to which the actuation member is coupled by the transfer mechanism has an extension which extends into the actuation member and which is adapted and configured to receive the other guide member during assembly. In particular, the extension is provided with at least one slot for guiding a pin connected to the actuation member, the pin and the slot being parts of the transfer mechanism. In an embodiment, the extension comprises a hollow cylinder portion connected to an end of the guide member facing the actuation member, the hollow cylinder portion comprising a wall which is provided with a coupling section for coupling the actuation member to the guide member.

To avoid inadvertent disassembly, securing means are provided in another embodiment of the targeting guide, the securing means being adapted and configured to prevent the actuation member from being unintentionally detached from the guide member to which the actuation member is coupled by the transfer mechanism. In particular, the securing means are part of the transfer mechanism. It is also conceivable that the restraint of the transfer mechanism is adapted and configured to form the securing means.

According to a further embodiment, the securing means comprise a thread portion formed at the guide member to which the actuation member is coupled by the transfer mechanism, and a thread portion formed at the actuation member, the thread portions being adapted and configured to cooperate during a first phase of assembly in which the actuation member and the guide member are screwed together before being coupled, and to be disengaged in a second phase of assembly in which the actuation member is coupled to the guide member by the transfer mechanism.

Particularly, the actuation member and the guide member to which the actuation member is coupled by the transfer mechanism each have a coupling portion adjacent the thread portion, the coupling portions forming the transfer mechanism and being arranged with respect to the thread portions such that in the first phase of assembly the coupling portions lie on opposite sides of the cooperating thread portions. It is e.g. possible to form the thread portion and the coupling portion of the guide member at a hollow cylinder portion of an extension of the guide member, the hollow cylinder portion having a longitudinal axis and the thread portion and the coupling portion being arranged one after another along the longitudinal axis. Further, a novel targeting system is suggested that supports a reliable and easy insertion, alignment and/ or assembly of an implant or implant system in fractured long bones or their preparation for the aforementioned procedures.

Said targeting system to be used in the internal fixation for fractured long bones comprises a targeting guide according to any of the embodiments described above, and at least one tool and/or tool guide to be received in the guide passages of the targeting guide. In particular, the tool is a drill or a bone screw and/or the tool guide is a sleeve or a cannula.

The present disclosure also relates to a surgical system to be used in the internal fixation for fractured long bones, comprising at least one implant which is adapted and configured to be inserted into a fractured long bone, wherein the implant has at least one implant passage, a targeting guide according to any of the embodiments described above, wherein the arm of the targeting guide is adapted and configured to be connected to the implant when the implant is inserted into the bone, and wherein at least one alignment axis of the targeting guide is aligned with the implant passage when the arm of the targeting guide is connected to the implant.

In particular, the implant has a longitudinal axis, the implant passage of the implant extending under an angle or oblique with respect to the longitudinal axis of the implant, i.e. non-parallel to the longitudinal axis of the implant.

According to an embodiment of the surgical system, the system comprises at least two implants, each implant having an implant axis and an implant passage which has an orientation with respect to the implant axis, the orientation of the implant passages of the two implants being different from each other, wherein the targeting guide has at least two pairs of guide passages, the respective alignment axis of the two pairs being non-parallel, and wherein for each implant the implant passage is aligned with at least one alignment axis of the targeting guide when the arm of the targeting guide is connected to that implant. In particular, the implant is a nail, more specifically a medullary nail.

The different embodiments of the targeting guide, the targeting system and the surgical system described above in accordance with the scope of the independent claim and the features realized there can naturally be combined with one another.

Further embodiments of the disclosure are also recited in the dependent claims, the description and the drawings.

Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples are intended for the purpose of illustration only and are not intended to limit the scope of the disclosure in any way. The figures are simplified and schematic. Details not necessary for the understanding of the invention are omitted.

The present disclosure will be explained in more detail and become fully understood from the detailed description and the accompanying drawings, wherein

Fig. 1 depicts an embodiment of the targeting guide in accordance with the present disclosure coupled to an implant disposed in a bone during the process of inserting a screw in the bone,

Fig. 2 shows another embodiment of the targeting guide, and

Fig. 3 shows yet another embodiment of the targeting guide. Fig. 1 shows a targeting guide 10 comprising an arm 1 1 and a first guide member 17. Arm 1 1 is coupled to an implant 13 - in the present case a medullary nail - which is disposed in the proximal end of a femur 15. In the present example, the patient requires a fixation of a head 15a of femur 15 to the rest of femur 15. It should be understood, that targeting guide 10 and variants thereof can be used to stabilize other bones, in particular long bones.

To this end, nail 13 has already been fixed in the medullary canal of femur 15. A screw 16 has been inserted in a passage 21 of nail 13 and screwed in head 15a using a sleeve 23. To ensure that an anatomical correct fixation of head 15a to femur 15 can be carried out, it is important that all the components involved are properly aligned and positioned. In

particular, the position and orientation of passage 21 of nail 13 has to be properly aligned with respect to femur 15 to allow the anatomical correct fixation of head 15a to femur 15 using screw 16. Orienting passage 21 can be carried out prior to coupling arm 1 1 to nail 13. However, it is also possible to change the position of nail 13 and/or to orient passage 21 using targeting guide 10.

Once nail 13 is positioned and oriented correctly, screw 16 has to be inserted to provide a coupling between head 15a of femur 15 and nail 13. During the surgery, the view on passage 21 is in most cases obstructed, so that the insertion of screw 16 is rather complicated. Targeting guide 10 is provided to facilitate the process of inserting screw 16. Arm 1 1 of targeting guide 10 provides a fixed geometrical relationship between passage 21 and a first guide passage 19 of first guide member 17. Pushing screw 16 with sleeve 23 through first guide passage 19 leads

automatically to a correct insertion of screw 16 in passage 21 , as first guide passage 19 and passage 21 are aligned along an alignment axis, assuming that arm 1 1 is properly attached to nail 13. Proper attachment of arm 1 1 to nail 13 can be achieved by providing suitable coupling means (not shown).

Sleeve 23 allows not only to insert screw 16 in passage 21 but also facilitates screwing it into head 15a thereby establishing a fixed

relationship between head 15a and bone 15 via nail 13. Fixation of screw 16 to nail 13 can be accomplished by conventional fixation means.

It should be understood that a tool can be inserted in passage 21 using targeting guide 10 in an analogous manner as described above in

connection with screw 16. Such a tool can e.g. be a drill used during a preparatory step before inserting screw 16 connecting head 15a to nail 13.

In order to foster the stability of the orientation of targeting guide 10 relative to femur 15 and its head 15a during the insertion process outlined above, a stabilization pin 24 is provided. Said pin 24 is directed and stabilized by stabilization sleeve 24a which in turn is disposed in a stabilization pin passage 24b that has a known geometrical position and orientation with respect to first guide member 17. Once pin 24 has been inserted in femur 15 and/or its head 15a, pin 24 reliably fixates head 15a inhibiting relative rotations of the components described above. In particular, more than one pin 24 is provided to reliably fix head 15a in the correct anatomical position during insertion of screw 16 and/or the preparatory steps prior to the insertion of screw 16. A reliable fixation may be achieved by selecting an orientation of pin 24 that is not parallel to the drill axis or insertion axis of the screw. If more than one pin 24 is used, their orientation with respect to each other may be non-parallel to improve the fixation of head 15a to femur 16 during surgery.

Specific circumstances may require that the insertion process of screw 16 has to be halted temporarily. To make sure e.g. that screw 16 does not slip from passage 21 - which might happen especially if a threaded portion of screw 16 has not yet bitten into the bone material of head 15a - and/ or to prevent unintentional misalignment of targeting guide 10, a mechanism is provided to fix screw 16 or sleeve 23 temporarily but reliably to first guide member 17.

A fixation of nail 13 in femur 15 can be improved by a distal locking concept comprising the insertion of one or more screw-like elements in corresponding distal locking openings provided on a distal end portion 13a of nail 13. In order to facilitate the insertion of said element(s) targeting guide 10 comprises one or more guide openings 24c provided on the first guide member 17. Advancing a tool, a tool guide or an implant

component through a corresponding guide opening 24c makes sure that the correct distal locking opening is reached automatically thereby facilitating the procedure of fixating nail 13 in femur 15. Hence, targeting guide 10 not only provides a well-defined geometrical relationship between the femur 13 and guide passage 19 for the implantation of screw 16, but it provides also openings 24c that allow to secure nail 13 to femur 15 and passages 24b that can be used to hold head 15a in the correct anatomical position during surgery. Specifically, two pairs of guide openings 2 are provided.

Fig. 2 shows an embodiment 10' of a targeting guide according to the present disclosure in a disassembled state. Its arm 1 1 comprises two arm segments 1 la, 1 lb which can be coupled by pins 14. Arm segment 1 lb is - in an assembled state of targeting guide 10' - coupled via pins 14' to first guide member 17 which in turn is provided with a number of stabilization pin passages 24b with different orientations to allow the use of one or more stabilization pin/sleeve-combinations 24, 24a as needed. Pins 14" are provided for fixing stabilization pin/sleeve-combinations 24, 24a relative to first guide member 17. Further, guide openings 24c can be seen. Like pin passages 24b, the guide openings 24c do not intersect a central axis of first guide member 17. In essence passages 24b and openings 24c are laterally offset from said central axis. First guide member 17 has therefore an oblong cross-section. Further, first guide member 17 is provided with guide passages 19, 19' to receive screw 16 coupled to sleeve 23. Passages 19, 19' are oriented in such a way that they fall in line with passage 21 of a corresponding nail 13 - when arm 1 1 is attached correctly to nail 13 - thereby each defining an alignment axis along which screw 16 is advanced during the insertion process. However, passages 19, 19' do not define parallel alignment axes. Each passage 19, 19' defines - together with a correspondingly oriented passage 21 of a suitable nail 13 - a specific alignment axis that allows taking patient specific anatomical situations into account. In other words, first guide member 17 can be used in combination with at least two different nails 13. It should be understood that first guide member 17 can be provided with an arbitrary number of guide passages 19, 19'.

First guide member 17 is provided with a channel in its interior that receives a second guide member 25 of essentially cylindrical shape. A portion of the channel of first guide member 17 is partly defined by a cylindrical wall 37 which forms a cylindrical extension 35 of first guide member 17 facing the actuation member 29. In an assembled state of targeting guide 10', second guide member 25 is disposed slidably in said channel. Grooves 26 on second guide member 25 cooperating with suitable protrusions in the channel prevent a rotation of second guide member 25 when positioned within the channel of first guide member 17.

Second guide member 25 and first guide member 17 can assume at least two different configurations as regards their relative position: (1) a release configuration and (2) a locking configuration. In the release configuration, guide passages 27, 27' provided on second guide member 25 are aligned with guide passages 19, 19', respectively, of first guide member 17. In other words, passages 27, 19 and 27', 19' are coaxially arranged in the release configuration. Screw 16 or sleeve 23 disposed in said passages 27, 19 or 27', 19' can therefore be moved without hindrance along the respective alignment axis. In case the insertion process of screw 16 and/or sleeve 23 has to be interrupted temporarily, second guide member 25 is moved linearly with respect to first guide member 17 thereby also displacing passages 27, 19 and 27', 19', respectively, relative to each other. Figuratively speaking, passages 27, 19 and 27', 19' then overlap at least partly, since they are no longer coaxially aligned. At a given point, an inner surface of passage 27 or 27' starts to press screw 16 or sleeve 23 against an inner surface of passage 19 or 19', respectively, thereby creating clamping forces that reliably fix the position of screw 16 or sleeve 23 relative to first guide member 17 and in consequence also relative to nail 13, femur 15 and head 15a. Second guide member 25 and first guide member 17 have then reached the locking configuration.

To effect the displacement of the second guide member 25 within first guide member 17, targeting guide 10' is provided with an actuation mechanism comprising actuation member 29. Actuation member 29 is rotatably coupled via connecting pin 29a to second guide member 25. Although a free relative rotation between actuation member 29 and second guide member 25 is allowed, said components 29, 25 are coupled in essence fixedly as regards linear displacements. In the course of the assembly of the targeting guide 10', second guide member 25 is inserted in the channel of first guide member 17. Actuation member 29 is coupled to guide member 25 and transfer pins 29b are disposed in corresponding holes 29c provided on actuation member 29. Then, actuation member 29 is placed over extension 35 which

consequently extends into member 29 in an assembled state. Since actuation member 29 is provided with a threaded portion 41 that matches a complementary threaded portion 39 on wall 37 of extension 35, member 29 can be secured to member 17. The process of screwing member 29 onto extension 35 is continued until threaded portion 41 has been translated beyond threaded portion 39. In this situation, actuation member 29 can be rotated without being automatically translated axially. Axial movements of actuation member 29 are only limited in one direction by threaded portions 39, 41 and in the opposite direction by the surface of the first guide member 17 from which extension 35 protrudes. A transfer mechanism based on restricted guidance is provided to obtain a defined axial movement of second guide member 25 coupled to actuation member 29 in response to a rotational actuation movement of actuation member 29. In order to assemble the transfer mechanism, securing pins 29b are aligned with grooves 37a cutting through threaded portion 39 provided on wall 37. Then, actuation member 29 is pushed in an axial direction until pins 29b reach slots 33 extending helically around the axial displacement axis of second guide member 25. Cooperation of pins 29b with slots 33 translates a rotation of actuation member 29 in a well defined movement of the second guide member 25 along the axial displacement axis.

It should be understood that alternative kinds of transfer mechanisms may be employed to translate an actuation of member 29 into a suitable displacement of second guide member 25 relative to first guide member 17 to cause the desired clamping forces. These clamping forces can in principle also be obtained by rotating second guide member 25 relative to first guide member 17. In general terms, the actuation movement and the displacement provoked thereby can both comprise rotational and/ or translational components depending on the construction of the chosen transfer mechanism. Fig. 3 shows another embodiment 10" of a targeting guide according to the present disclosure in a disassembled state. Many components of targeting guide 10" are similar to those of targeting guide 10'. Differences exist, however, in particular with respect to the actuation mechanism and the transfer mechanism. The perspective of Fig. 3 provides an unobstructed view on details of the connection between second guide member 25 and actuation member 29 via connecting pin 29a placed in a notch 26a of member 25. The

connection described above is essentially the same as that of targeting guide 10'.

Second guide member 25 of targeting guide 10" is not provided with grooves 26. As it can be inferred from the contour of an end face 43 of member 25 visible in Fig. 3, rotational displacements are suppressed by a non-rotational symmetry of - at least parts of - the body of second guide member 25 and a complementary cross-section of the channel within first guide member 17 which receives second guide member 25 in an

assembled state of targeting guide 10".

Although the transfer mechanism of targeting guide 10" is also based on a restricted guidance provided by a pin-slot-cooperation, actuation member 29 is secured to first guide member 17 differently. When assembling targeting guide 10", at first second guide member 25 (already coupled to member 29) is disposed in the channel of first guide member 17. Then, actuation member 29 is placed over extension 35 of first guide member 17. To secure member 29 to member 17, transfer pin 29b' in inserted in holes 29c, thereby passing through slots 33 in wall 37. Transfer pin 29b' therefore secures actuation member 29 to first guide member 17 and at the same time represents a component of the mechanism that translates a rotational actuation movement of member 29 in a translational movement of second guide member 25. All anatomical terms relating to directions and locations, such as anterior, posterior, medial, lateral, proximal, distal and sagittal, refer to an

implanted state of the components and implants described above.

The description of the disclosure is merely exemplary in nature, and, thus, variations that do not depart from the gist of the disclosure are intended to be within the scope of the disclosure. List of reference numerals:

10, 10', 10" targeting guide

1 1 arm

1 1a, l ib arm segment

13 nail

13a distal end portion

14, 14', 14" pin

15 femur

15a head of the femur

16 screw

17 first guide member

19, 19' guide passage of first guide member 21 passage of implant

23 sleeve

25 second guide member

24 stabilization pin

24a stabilization sleeve

24b stabilization pin passage

24c guide opening

26 groove

26a notch

27, 27' guide passage of second guide member 29 actuation member

29a connecting pin

29b, 29b' transfer pin

29c hole

33 slot

35 extension

37 wall

37a groove

39 thread portion of first guide member

41 thread portion of actuation member 43 end face of second guide member