This application is a U.S. national stage filing under 35 U.S.C. 371 of international patent application no. PCT/EP2017/071935, filed on Sep. 1, 2017, which claims priority to Swiss patent application no. CH01138/16, filed on Sep. 2, 2016, the contents of both of which are incorporated herein by reference in their entirety.
The invention relates to a bone clamp, in particular a surgical bone clamp, which is equipped with an adapter for a measurement aid for computer-assisted surgery. The invention also relates to a system comprising a bone clamp and a measurement aid.
Important demands on such bone-mounted bone clamps are that the measurement aid maintains a constant geometric reference to the bone during the surgical procedure and that the attached bone clamp does not interfere with the surgical procedure. In particular, minimally invasive procedures place high demands on the design and ergonomics of a bone clamp and measurement aids.
In each case, a fixed geometric reference of the measurement aid to the bone is sought. Force effects on the measurement aid, such as unintentional abutment by the surgeon, must neither change the position of the measurement aid nor impair its attachment in or on the bone. Acting forces on measurement aids on long lever arms can generate large torques and thus allow large forces to act on the screwed connections in the bone material. Especially with minimally invasive procedures, the space available for the measurement aid is limited, which increases the risk of unintentional collisions. The bone clamp must therefore lie as flat as possible on the bone.
The state of the art for the attachment of a measurement aid to a bone, in particular in the area of the femoral neck bone in a hip joint operation, can be described with reference to the following disclosure and patent documents.
U.S. Pat. No. 5,807,252 [Aesculap AG] describes a bone screw and US 20150038836 A1 [Intellijoint Survivals Inc.] describes a screwed mounting device for a measurement aid, which is screwed to the bone at a suitable location directly or by means of an adapter. A disadvantage of this type of fastening technique is that relatively large forces can act on the screw connection or the bone material that can be generated, for example, in a collision with the measurement aid, for example, by an accidental abutment on the measurement aid. The screw connection must therefore be dimensioned correspondingly massively, which also results in a large altitude with respect to the bone.
US2008/0027471 A1 [Hauri] describes a clamp with at least two mutually movable jaw parts, which is clamped to the bone. The clamping mechanism consists of interlocking sawtooth-shaped surfaces. The necessary force is generated by a pair of pliers. The actual secure fit on the bone is made possible by spikes or other sharp structures on the clamp, which are pressed into the bone surface by the clamping process. In this case too, large forces can act locally on the bone. Minimally invasive interventions may not provide the necessary space. In addition, it is difficult to put this clamp flat on the bone, since the clamp cannot adapt to the bone when contracting.
U.S. Pat. No. 8,002,772 B2 [Kinamed, Inc] describes a clamp with two mutually movable toothed jaw parts, which are clamped to the bone by means of an integrated threaded rod. Thanks to the jaw parts rotatable about axes of rotation, the clamp can adapt to the surface topology of the bone. Spikes or other sharp structures, which are pressed into the bone surface by the clamping process, allow a secure fit of the clamp on the bone. The local force on the bones can be relatively large when clamping.
U.S. Pat. No. 6,711,431 B2 [Kinamed Inc.] describes a stiff collar that is temporarily attached to the large trochanter at the femur by means of strings. The strings are wrapped around the femur. At this collar measuring means are attached. This attachment method protects the bone.
The object of the present invention is to further develop bone-fixed bone clamps for surgery in such a way that firstly, the forces of the clamp acting on the bone are optimally distributed, secondly, the bone clamp can attach well to the bone structure when closing, thirdly, the injury to the bone and the surrounding tissue are limited to a minimum and fourthly, measurement aids do not get in the way of the attending physician when performing the operation. In addition, the attachment and removal of the clamp on the bone should take ergonomic aspects into account and the fastened clamp should not interfere with accessibility during surgery, particularly minimally invasive surgery.
The object is solved by the features of the claims. Advantageous developments are subject of the dependent claims. The advantage of the invention is that the proposed surgical bone clamp comprises a relatively large proportion of the bone circumference, that the bone clamp itself centers around the bone when it is fixed, and that the bone clamp has a small height relative to the bone surface.
When the term “for example” is used in the following description, this term refers to embodiments and/or variants, which is not necessarily to be understood as a more preferred application of the teachings of the invention. Similarly, the terms “preferable”, “preferred” are to be understood by referring to an example of a set of embodiments and/or variants, which is not necessarily to be understood as a preferred application of the teachings of the invention. Accordingly, the terms “for example,” “preferred,” or “preferred,” may refer to a plurality of embodiments and/or variants.
The following detailed description contains various embodiments of the inventive bone clamp. The description of a particular bone clamp is to be considered as exemplary only. In the specification and claims, the terms “contain,” “include,” “comprise” are interpreted as “including, but not limited to.”
A bone clamp for attaching measurement aids to a bone includes a first and a second clip and an adapter. The adapter includes a pulling mechanism and a locking mechanism. By actuating the pulling mechanism, the position of the first clip relative to the second clip is changeable. By operating the pulling mechanism or the locking mechanism, the position of the first clip relative to the second clip can be fixed. The first and second clips each have an inner face which is oriented in the direction of a bone surface of the bone. The first clip contains one or more spikes on the inside. The second clip contains a sliding edge on the inside. By means of a spike, a substantially punctiform support on the bone surface can be realized. By means of a sliding edge, a linear or planar support on the bone surface can be realized.
According to an embodiment, the second clip has a clip axis, wherein the sliding edge is arranged parallel to the clip axis. In particular, the sliding edge can be designed as a cutting edge extending parallel to the clip axis. A sliding edge may be mounted on the first clip at a distance from the spike.
The first clip may have a clip axis, wherein the sliding edge is arranged parallel to the clip axis. According to one embodiment, the two sliding edges can be parallel to the corresponding clip axes. According to an embodiment, the two sliding edges and the spike may lie in the same plane. The sliding edges can enclose an angle smaller than 90° to each other.
In an embodiment, at least one of the first and second clips may be shaped to partially enclose the bone.
According to an embodiment, at least one of the first or second clips may be designed to be at least partially flexible. In particular, the first clip can be connected to the second clip via an adapter which is designed as a flexible clip element. Alternatively, in addition to the adapter, a flexible clip element may be formed on one of the first or second clips.
According to an embodiment, the locking mechanism comprises first and second sawtooth-like structures, which are arranged on the first and second clip and are intended for mutual engagement.
According to an embodiment, the pulling mechanism comprises a gear arranged on the first clip and a rack disposed on the second clip, the rack and the gear being intended for mutual engagement. According to an embodiment, the gear may be removably mounted on the first clip.
According to an embodiment, the adapter includes a fastening device for a measurement aid. The attachment device for the measurement aid may be removable from the first clip. In particular, the measurement aid can be temporarily fixed for measuring purposes on the bone clamp in a geometrically defined manner by means of adapters. At least one eyelet for a bone screw may be provided on at least one of the first and second clips. The eyelet can be designed to receive a head locking screw.
According to an embodiment, the force of the first and second clips can be adjusted to the bone by means of a torque measurement device. The torque measurement device may be attached to the pulling mechanism.
According to an embodiment, a plurality of spikes can form a spike group.
According to any one of the embodiments, at least one of the sliding edges can include a plurality of cutting edges, wherein the cutting edges of the sliding edge form a group of cutting edges.
A system according to any one of the embodiments comprises a bone clamp comprising an adapter containing a measurement aid. The measurement aid may be releasably attached to the adapter and extending at least over the tissue surface of the patient or protruding beyond the tissue surface of the patient. In particular, the measurement aid has a longitudinal dimension which extends from the surface of the first or second clip to the end of the measurement aid and forms a first lever arm. A second lever arm may extend from the surface of the first or second clip to the projection point of the track center of the sliding edge. Advantageously, the ratio of the length dimensions of the first lever arm to the second lever arm is a maximum of five. According to a preferred embodiment, the ratio of the length dimensions of the first lever arm to the second lever arm is a maximum of four. According to a particularly preferred embodiment, the ratio of the length dimensions of the first lever arm to the second lever arm is a maximum of three, thus, the first lever arm is substantially three times longer than the second lever arm.
The proposed bone clamp according to one of the preceding embodiments can in particular encompass a relatively large proportion of the bone circumference. The bone clamp can be stably aligned by the spike and the sliding edge or the sliding edges on the inside of the bone. The bone clamp has a very small height with respect to the bone surface because of the detachable adapter.
The invention will be explained in more detail with reference to an embodiment of a bone clamp on the femur for a hip operation, which is illustrated in the drawings.
It is shown in:
The positioning of the bone clamp 2 is accomplished by a suitable setting instrument, with which the bone clamp 2 can be held and placed in position, which is not shown in the drawing. Preferably, the pulling mechanism 8 or the locking mechanism 13 of the bone clamp 2, as shown in
For example, the measurement aid 7 may comprise a marking element and a rod element. The rod element may for example have a length of about 11 cm. The marking element may for example have a substantially rectangular shape. According to an embodiment, the length of the rectangle is approximately 2.5 cm. The width of the rectangle is approximately 2.5 cm.
The pulling mechanism 8 can be removed as needed from the bone clamp 2, thereby freeing this space for the surgeon.
Instead of the pulling mechanism 8, a device for mounting the measurement aid can be mounted. Depending on the design of the adapter 6 more than one measurement aid can be attached to the device. Also, this adapter 6 or the measurement aid can be temporarily removed as needed. It is important that the adapter 6 can be re-attached to the attached bone clamp 2, so that the same geometric reference of the measurement aid is restored with respect to the bone. The adapter 6 for attaching the measurement aids can simultaneously also contain the pulling mechanism 8 of the bone clamp 2. The adapter 6 for the measurement aids may be mounted at another suitable location, in particular not directly at the pulling mechanism 8.
In the following, the attachment of the bone clamp 2 will be described. The surgeon places the bone clamp 2 on the bone as indicated in
The result is a rigid bone clamp which, due to sufficient anchoring by the spike or spikes 20, or the sliding edges 22, 23 in the bone 1, has a fixed geometrical relation to the bone 1. The shape of the first and second clips 11, 12 is important for a tight clamping seat: the sliding edge 23 must not slide away from the bone during contraction. Therefore, the second clip 12 with the sliding edge 23 must partially surround the bone. The term “partially encompassing” should be understood in particular that at least half of the bone circumference of the first clip 11 and/or the second clip 12 is detected. In particular, the two sliding edges 22, 23, respectively, their associated clip axes 24 and 25, enclose an angle of less than 90°.
A particularly low height of the mounted bone clamp 2 is achieved by a slightly curved clamp shape, which is adapted to the bone surface. In addition, each of the first or second clips 11, 12 may be at least partially flexible. If at least one of the first or second clips 11, 12 contains a flexible material, this flexible material can adapt to the bone surface particularly well.
Thus, whenever the locking mechanism 13 is released, the end of the first clip 11 can move away from the end of the second clip 12 and the sliding edge 22 and the spike 20 can be released. The clips 11, 12 of the bone clamp can be removed. The sleeve element 9 remains according to the illustration of
Since the sleeve element 9 on the second clip 12 is free to move when the locking mechanism is open, this sleeve element can also be used as a pulling mechanism. The sleeve element 9 may be partially screwed onto the second sawtooth-like structure 26 of the second clip before the first sawtooth-like structure 21 is connected to the sleeve element 9. The sawtooth-like structures 21, 26 are thus arranged offset to one another according to this illustration. The more the two sawtooth-like structures overlap in the locked state of the locking mechanism 13, the greater the clamping force, that is, the deeper the sliding edge 23 and the spike 20 penetrate into the bone surface.
By adapting the clamping force, the bone clamp can be used for bones of different consistency, in particular different hardness. For harder bones, a greater clamping force can be selected by increasing the degree of overlap of the sawtooth-like structures. Thus, according to the present configuration, the adapter 6 can also perform the function of a pulling mechanism 8.
The first clip 11 and the second clip 12 are received in the sleeve element. The thread is schematically indicated by a dashed line. The cross sections of the first and second clip 11, 12 are semicircular according to this embodiment. If the first and second clips 11, 12 are arranged opposite one another, a circular cross-sectional area with an external thread results. The external thread of the first and second clip 11, 12 is particularly suitable for engagement with the internal thread of the sleeve element 9.
The penetration of the spike into the bone surface and the rotation about the center of rotation are coupled processes. Two or more spikes 20 forming a spike group may be provided instead of a single spike 20 as shown in
The spike 20 thus remains stationary in the bone 1 during the attachment process of the bone clamp 2 and during the release process of the bone clamp 2. Depending on the bone surface and expected bone hardness, as well as the bone geometry, a flat design, e.g. with a roughened surface may be provided. In addition to the spike 20, the first clip 11 may also have a sliding edge to allow the occlusion of the bone on both sides.
The bone axis 55 is positioned perpendicular to the plane of the drawing, as shown in
If the spike 20 is replaced by a sliding edge 22, 23, for example, an edge or cutting edge, the angle of rotation 58 about the bone axis 55 is less secured, but may be sufficiently secured depending on the bone cross-section. If a sliding edge 22, 23 is replaced by a spike 20 or all sliding edges 22, 23 replaced by spikes 20, the bone surface may be bruised when contracting the bone clamp.
In principle, a spike 20 and the two sliding edges 22 and 23 are sufficient to prevent rotations and translations of the attached bone clamp. The local forces on the bone surface and tissue, such as muscle attachments, can be reduced by increasing the number of spikes or spike groups 20 or the blades or blade combinations 22, 23 or by the curved shape of the sliding edges 22, 23, for example according to the embodiments shown in
The cross section of the bone clamp 2 is increased or widened by increasing the number of spikes 20 and sliding edges 22, 23. Thereby, the ergonomics of the manipulation of the bone clamp can increase.
The bone clamp 2 of
In
The pulling mechanism 8 is not fully shown in
The second clip 12 has a substantially straight clip portion and a curved clip portion. The straight clip portion is provided with a plurality of recesses, which can perform the function of a rack 27. According to the present embodiment, the straight clip portion on the outside has two edges along which the recesses are arranged.
The recesses have the shape of indentations that run along the two outer edges. The indentations are intended, for example, to receive the teeth of a gear 28 of an actuating arrangement 35, which is illustrated in
Each of the recesses has a first and a second recess wall. The recess wall according to this embodiment has a substantially triangular cross-section.
Because two edges of the straight clip portion each include a series of recesses, a gear 28 may be engaged with each of the two rows of recesses. The actuating arrangement 35 can thus be mounted in two different positions on the guide element 31. Depending on the desired application, thus, the actuating arrangement 35 can be placed in the appropriate position. This option can greatly facilitate the operation of the pulling mechanism 8 depending on the installation position of the bone clamp. The guide element 31 is thus symmetrical with respect to a longitudinal center plane.
The guide element 31 is arranged according to this embodiment at the end of a substantially straight clip portion of the first clip 11. In
The substantially straight clip portion of the first clip 11 also includes two projections, each having an eyelet 80 for a bone screw. With bone screws, which are passed through the two eyelets 80, the bone clamp 2 can be additionally attached to the bone. The eyelets 80 include an internal thread. The bone screws are not shown in this illustration.
The function of the first sawtooth-like structure 21 and the slot 39 is best seen in the illustration according to
Therefore, the recesses attached to the edges of the second clip are not visible in this illustration. The substantially straight clip portion of the second clip 12 may also have a slight curvature, which in
When the pulling mechanism 8 is actuated, the substantially straight clip portion of the second clip 12 slides over the substantially straight clip portion of the first clip 11. The feed direction of the substantially straight clip portion of second clip 12 is predetermined by the guide element 31 and the pin 40 sliding in the slot 39.
The second sawtooth-like structure 26 thus engages with the first sawtooth-like structure 21 of the substantially straight clip portion of the first clip 11. The teeth of the second sawtooth-like structure 26 engage the tooth roots of the first sawtooth-like structure 21. The second sawtooth-like structure 26 may comprise a single tooth, but may also have a plurality of teeth to reduce the flank pressure on the tooth flank of the counter tooth of the first sawtooth-like structure 21. Advantageously, the second sawtooth-like structure 26 may have at least 3 teeth, in particular the second sawtooth-like structure 26 may have at least 5 teeth. Each of the teeth may in particular have tooth flanks of different steepness. In particular, for the second sawtooth-like structure 26, the steepness of the flank, which is directed towards the end of the substantially straight clip portion of the second clip 12, may be less than the steepness of the flank, which is oriented towards the pulling mechanism 8.
In particular, for the first sawtooth-like structure 21, the steepness of the flank, which is directed towards the guide element 31, may be less than the steepness of the flank, which is aligned in the direction of the curved clip section of the first clip 11.
Therefore, the first sawtooth-like structure 21 latches with the second sawtooth-like structure 26 in any position set by the pulling mechanism 8.
The locking mechanism 13 thus includes the pin 40 as well as the second sawtooth-like structure 26. The second sawtooth-like structure 26 may be disposed on the end of the substantially straight clip portion of the second clip 12. The pin 40 may be received in a bore disposed in the end of the substantially straight clip portion of the second clip 12.
The pin 40 may be connected to a sliding element 41. The sliding element 41 forms a spring-mounted guide of the second clip 12 on the first clip 11. This spring-mounted guide has the task of making the entire closing path smooth in the loose state of the bone clamp 2. The two sawtooth-like structures 21, 26 are held apart by the sliding element 41 for this purpose.
The sliding element 41 has rails on the side facing the first clip 11. On these rails, the sliding element 41 can slide along the surface of the first clip 11. The pin 40 limits the free path of several centimeters.
In addition, the sliding element 41 may move perpendicularly to the clip surface along the pin 40. The play for this movement amounts in the normal direction to the clip surface a few millimeters, in particular about one millimeter.
The pin may have a nut 42 on the upper side, in which a spring element 43 is held, which rests on the outside of the sliding element 41. The nut 42 may be welded to the pin 40. The spring element 43 pushes the sliding element 41 against the outer surface of the end of the second clip 12. This pressure force is transmitted to the second sawtooth-like structure 26, which thus engages in the first sawtooth-like structure 21 of the first clip 11.
Thus, the substantially straight portion of the first clip 11 is pressed against the end of the second clip 12 by the spring element 43, so that the first sawtooth-like structure 21 engages in the corresponding second sawtooth-like structure 26. When the pulling mechanism 8 is actuated, the two sawtooth-like structures 21, 26 move along their less steep flank and compress the spring element 43. As soon as the next tooth root has been reached, the spring element 43 is released again so that the two sawtooth-like structures lock into one another. The end of the second clip can thus be moved away during the closing operation by the sliding movement of the first clip 11, whereby a progressive irreversible locking takes place, which leads to the desired attachment of the bone clamp 2 on the bone.
If the bone clamp 2 is to be removed from the bone again, the lock must be released with a specially developed unlocking tool. Any accidental unwanted loosening of the bone clamp 2 is thus excluded because the two sawtooth-like structures 21, 26 are held by the spring element 43 in engagement. By means of the unlocking tool, which may be formed as a lever device 61, as shown in
On the inner face 16 of the curved clip portion of the first clip 11, two spikes 20 are arranged. On the inner face 17 of the curved clip portion of the second clip 12, a sliding edge 23 is arranged. On the inner face of the substantially straight clip portion of the first clip 11, a sliding edge 22 is arranged. The spikes 20 and the sliding edge 23 and the sliding edge 22 are located on the bone surface and can also penetrate into the bone surface for better grip, whereby slipping of the bone clamp 2 can be securely prevented when the first and second sawtooth-like structures 21, 26 are in engagement position. When the release mechanism is actuated, the distance between the spikes 20 and the sliding edge 23 or the sliding edge 22 can also increase. The bone clamp 2 can be removed from the bone 1 without further injury to the bone surface. The sliding edge 23 may comprise a pair of sliding edges. The sliding edges of the pair may be arranged parallel to each other. The guide element 31 or the end of the first clip 11 may have a sliding edge 22. When the bone clamp 2 is mirror symmetric with respect to the longitudinal center plane, as shown in
An embodiment of an actuating arrangement 35 associated with a pulling mechanism 8 is shown in
The second coupling element 33 is connectable or connected to the actuating arrangement 35. According to an embodiment, the second coupling element 33 comprises a threaded pin or a locking screw which can be brought into engagement with the first coupling element 32 designed as a threaded bore or seat element according to this exemplary embodiment, in particular, it can be screwed or locked.
The second coupling element 33 may be received in a bore 36 of the actuating arrangement 35. The bore 36 may include a thread which is not visible in FIG. 10. The second coupling element 33 can be actuated with a coupling tool, for example a screwdriver.
The actuating arrangement 35 comprises a gear 28, which engages in the assembled state in the rack 27 mounted on the second clip 12. The gear 28 may be formed as a pinion. The gear 28 may be disposed on a shaft 37 which is rotatably supported in a housing 38. The shaft 37 may have a recess which is suitable for receiving a clamping tool 65. A clamping tool 65 may have a shape that matches the shape of the recess so that the clamping tool 65 can be inserted exactly into the recess of the shaft 37. By rotation of the clamping tool 65, the shaft 37 is rotated, which in turn initiates the rotation of gear 28 which is fastened to the shaft 37. At least a portion of the teeth of the gear 28 is engaged with the teeth on the rack 27, so that upon rotation of the gear 28, the rack 27 is displaced relative to the guide element 31, so that the first clip 11 can be moved relative to the second clip 12.
The openings 46 are advantageously arranged in different orientation to each other on the docking element 45. According to this embodiment, they have a specific position relative to one another, so that the geometric relationship of the openings 46 to one another is defined. This means that the measurement aid can be arranged in different spatial directions and in different orientations. Due to the orientation of the openings, the orientation of the measurement aid 7 is precisely defined, so that their position in space is exactly defined. Of course, according to an embodiment, not shown, only a single opening 46 may be provided. According to another embodiment, not shown, more than two openings 46 may be provided.
According to the present embodiment, the openings 46 have a substantially triangular cross-sectional area. One of the sides of the triangle may have a recess 47, which is intended to receive a correspondingly shaped projection of the plug element 76 (see
The clamping tool and coupling tool may also be the same according to an embodiment, not shown.
It will be apparent to those skilled in the art that many other modifications are possible in addition to the described embodiments without departing from the inventive concept. Of course, it is possible to combine in particular the embodiments of the bone clamp and the system, in particular their first and second clip, adapter, measurement aids, pulling mechanisms or locking mechanisms with each other to achieve optimal properties of the bone clamp or the system for the appropriate application.
The inventive subject matter, therefore, is not to be restricted by the preceding description and encompasses the scope as laid out by the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context of the claims. In particular, the terms “comprise” and “include” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification or the claims refer to at least one of an element or compound selected from the group consisting of A, B, C . . . and N, the text should be interpreted as requiring only one element from the group, not a combination of A plus N, or B plus N, or any other combination of two or more elements or components of this group.
Number | Date | Country | Kind |
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01138/16 | Sep 2016 | CH | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2017/071935 | 9/1/2017 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2018/041984 | 3/8/2018 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5807252 | Hassfeld | Sep 1998 | A |
6711431 | Sarin | Mar 2004 | B2 |
8002772 | Sarin | Aug 2011 | B2 |
20060100638 | Sarin | May 2006 | A1 |
20080027471 | Hauri et al. | Jan 2008 | A1 |
20150038836 | Hladio et al. | Feb 2015 | A1 |
20150327937 | Schuele | Nov 2015 | A1 |
Number | Date | Country |
---|---|---|
102006035602 | Feb 2008 | DE |
1779798 | May 2007 | EP |
1872733 | Jan 2008 | EP |
Entry |
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International Search Report for PCT/EP2017/071935, dated Oct. 27, 2017, 6 pages. |
International Preliminary Report on Patentability Chapter I for PCT/EP2017/071935, dated Mar. 5, 2019, 13 pages. |
Number | Date | Country | |
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20210038276 A1 | Feb 2021 | US |