Untitled record

ES 2 344 595 T3

DESCRIPTION

Medical system and system parts for spatially fitting a guidance device relative to a body implant.

Field of the invention

The present invention relates to the field of surgical instruments. In particular, the present invention relates to a medical system for removably establishing an orientation between a body implant and a guiding device. More specifically, the present invention relates to a medical system and the parts of the system, which allows a relative spatial orientation to be precisely established between a bone stabilizing implant and a guiding device to anchor the implant to an internal part of the body. .

Background of the invention

To enable reliable stabilization of a broken bone in its normal position, special bone stabilization implants are often used. Such implants are, for example, metal plates, which are made, for example, of surgical steel. Such plates are generally attached to parts of the bone by means of threaded screws, which are inserted into the bone tissue after having pre-drilled or pre-directed holes have been made. These pre-drilled holes enable a reliable screwing procedure, thereby significantly reducing the risk of further destruction of the bone with the screw.

To facilitate the drilling of these pre-drilled holes, so-called guiding devices are known, which function as a drilling template. In this context, a guide device is removably attached to the metal plate at a precise spatial position.

Guiding devices are also used in conjunction with immobilization pins, which are driven into intramedullary tissue. In this way, the position of a transverse hole within the locking nail can be precisely determined. The transverse hole is adapted to accommodate a fixation screw, which is inserted transversely into the corresponding bone section.

US6,224,601B1 discloses the use of a guiding device in an auxiliary osteosynthesis for the treatment of subtrochanteric, peritochanteric and femoral neck fractures.

Document US2004 / 0015174A1 discloses devices according to the preamble of claims 1 and 7.

There may be a need for a medical system and parts of the medical system to spatially adjust a guidance device relative to a body implant, allowing for fast, simple and reliable relative position adjustment.

Summary the invention

To meet the above defined need, an adapter device, a positioning arm and a medical system are provided according to the independent claims.

According to one aspect of the invention, there is provided an adapter device adapted to be connected to a body implant to removably establish a spatial orientation between a body implant and a guiding device, specifically to removably establish a spatial orientation between a bone stabilizing implant and a guiding device to anchor the implant to an internal part of the body. The adapter device comprises a fixing element, which is designed in such a way that such a coupling element of a positioning arm can be hooked to the adapter device. The adapter device further comprises a locking element, which is designed such that a snap mechanism of the positioning arm automatically engages the locking element when the positioning arm, when hooked onto the adapter device, rotates relative to the device. adapter to a final angular position and approaches the final position. The adapter device comprises an additional fixing element, which is designed such that an additional coupling element of the positioning arm can be hooked onto the additional fixing element. This can have the advantage that a mechanically stable three-point bearing is automatically generated when the snap mechanism of the positioning arm engages the locking element.

This aspect of the present invention is based on the idea that a connection can be made both by shape adjustment and by force adjustment between the adapter device and the positioning if the positioning arm oscillates about a predefined center of rotation towards a final angular position.

The shape-fitting connection may be provided by the contour of the adapter device, which contour adjusts complementary to a contour provided on the positioning arm. When the snap mechanism engages the locking member, the contour of the adapter device abuts against the contour of the positioning arm so that a shape-fitting connection is made.

ES 2 344 595 T3

The force fit connection may be provided if the adapter device comprises a slightly different curvature than the corresponding portion of the positioning arm, which portion abuts against the adapter device when the snap mechanism engages the locking element. In this way, the adapter device and / or the positioning arm are made of a material that is at least partially elastic. When the shape-fit connection is established between these two parts, at least one of these two parts is elastically deformed, whereby the deformation force provides the force-fit connection. Such a force fit connection has the advantage that there is practically no spatial tolerance between the adapter device and the positioning arm. Therefore, a very precise spatial positioning can be established between the adapter device and the positioning arm.

The positioning arm snap mechanism automatically engages the locking element when the positioning arm has approached the end position. During the entire movement the adapter device remains engaged in the adapter device. The rotation is carried out around an axis of rotation, which passes through a region in which the fixing element and the coupling element abut each other.

The adapter device is adapted to be connected to a bone stabilizing implant. The adapter device and implant can be made as one piece or as two or more individual pieces. However, it has to be ensured that the adapter device and the implant can be rigidly fixed to each other.

The positioning arm is adapted to be connected to a guide device. The positioning arm and the guide device can be made as a single piece or as two or more individual pieces. In the latter case it must also be ensured that the positioning arm and the guiding device are rigidly fixed to each other, so that the positioning arm is friction and / or shape locked provides a mechanically stable platform for the guiding device. .

According to an embodiment of the present invention, the fixing element is a projection projecting from a body of the adapter device. This can provide the advantage that the adapter device can be easily manufactured from a single piece of material.

It should be noted that the fixation element can be any element that allows the positioning arm to be hooked onto the adapter device. For example, the fixing element can also be a recess, in which a projecting coupling element of the positioning arm engages.

According to a further embodiment of the invention the immobilization element comprises an edge. The edge may be elastic so that a rigid or hard element of the snap mechanism can be engaged. Alternatively, the edge may be rigid so that an elastic and / or flexible member of the snap mechanism can be engaged. An elastic and / or flexible element can be made of a flexible material or by means of a spring-type element, which pre-tensiones the elastic element.

Furthermore, when two fixation elements are involved to provide a mechanical coupling between the adapter device and the positioning arm, the axis of rotation of the positioning arm is precisely defined by the spatial arrangement of two regions in which the two elements clamp and the two coupling elements abut each other, respectively. Thus, an operator, and in particular a surgeon, can simply and effectively fix the positioning arm to the adapter device in a reliable spatial position.

According to a further embodiment of the invention, the additional fixing element is an additional projection projecting from a body of the adapter device. As described above with respect to the fixing element, the additional fixing element can also be a recess, in which an additional projecting coupling element engages.

According to a further embodiment of the invention, the adapter device is integrally formed with the implant. This can provide the advantage that no additional effort is required to provide a rigid and mechanically reliable connection between the adapter device and the implant.

However, it should be noted that, as an alternative, the coupling element can also be formed independently of the implant. In this case, it must be ensured that a rigid and mechanically reliable connection is provided between the adapter device and the implant. This can be done, for example, by using suitable coupling elements such as screws, pins, nails, rivets, etc.

According to a further embodiment of the invention, the adapter device is integrally formed with an internal fixator and, in particular, with a plate, which is used for bone stabilization. Such an internal fixator or such a plate can be used to fix a broken bone in its anatomically correct position. In this way, the plate is fixed to different parts of the bone by means of screws, pins, ties, etc. In particular, when using screws to fix the plate, a guiding device can be very useful, a guiding device comprising a drilling template. Thus, an operator, and in particular a surgeon, is able to precisely drill holes in the bone, whereby each hole is formed in exactly the correct position relative to a corresponding through hole in the plate.

ES 2 344 595 T3

According to a further aspect of the invention, a positioning arm is provided removably establishing a spatial orientation between a body implant and a guiding device, in particular for removably establishing a spatial orientation between a bone stabilizing implant and a device. guide to anchor the implant to an internal part of the body. The positioning arm comprises a coupling element, which is designed so that it can be coupled to a fixation element of an adapter device adapted to be connected to said body implant, so that the positioning arm is hooked on the adapter device . The positioning arm further comprises a snap mechanism, which is designed to automatically engage in the locking element of the adapter device, when the positioning arm, when engaged in the adapter device, rotates relative to the adapter device towards the final angular position. .

The positioning arm comprises an additional coupling element, which is designed so that it can be coupled to a further fixing element of the adapter device. As already mentioned above, the use of an additional coupling element together with a corresponding additional fixing element provides the advantage that the axis of rotation of the positioning arm is precisely defined. In addition, a stable three-point bearing is automatically generated when the positioning arm snap mechanism engages the locking member.

According to an embodiment of the invention, the coupling element is a notch. The notch can be directly formed in the body of the positioning arm. Preferably, the notch is formed in a projection that extends from the body of the positioning arm.

According to a further embodiment of the invention, the snap mechanism comprises a hook-type element, which is adapted to engage with the immobilization element. Preferably, the hook-like element is elastic, so that it is capable of engaging a rigid locking element.

However, it should be clear that the positioning arm should also be made with a rigid or non-flexible hook-like element, which is adapted to engage an elastic locking element or at least one elastic part of the locking element.

An elastic hook-type element can be made of a flexible material or by means of a spring-type element, which pre-tensiones the hook-type element.

According to a further embodiment of the invention, the additional coupling element is an additional notch. As described above with respect to the fixing element, the additional fixing element can also be a recess, in which an additional projecting coupling element engages.

The additional notch may be formed in the same way, similarly or differently from the previously described notch. Therefore, the additional notch can be directly formed in the body of the positioning arm. Preferably, the additional notch is formed in a projection that extends from the body of the positioning arm.

According to a further embodiment of the invention, the positioning arm further comprises a handle to facilitate manual rotation of the positioning arm relative to the adapter device. Preferably, the handle is ergonomically shaped. This has the advantage that easy use of the positioning arm is guaranteed even if the surgeon is in a state of physical and / or mental stress, which often happens, particularly during complicated and lengthy surgical procedures.

According to a further embodiment of the invention, the positioning arm further comprises a locking device, which is adapted to lock the snap mechanism. The locking device has the advantage that accidental opening of the mechanical connection between the snap mechanism and the locking element can be effectively prevented. Of course, the positioning arm can be removed from the adapter device by suitable movement of the locking device after the surgical procedure using the guiding device has been carried out successfully.

According to a further embodiment of the invention, the locking device comprises a rotary lever. Preferably, the rotary lever is integrated into a handle, so that the locking device can be manufactured without requiring additional space.

According to a further embodiment of the invention, the positioning arm is integrally formed with the guide device. This can provide the advantage that no additional effort is required to provide a rigid and mechanically reliable connection between the positioning arm and the guide device. Furthermore, accidentally wrong mounting of the guiding device can also be effectively prevented.

According to a further embodiment of the invention, the positioning arm is adapted to be removably connected to the guide device. This can provide the advantage that the guide device can be formed independently of the positioning arm. It is clear that, in this case, it must be ensured that a rigid and mechanically reliable connection is provided between the positioning arm and the guide device.

ES 2 344 595 T3

A configuration in which the positioning arm and the guiding device are formed as separate objects can provide the advantage that the implant, the adapter device, the positioning arm and the guiding device can be included in a modular construction kit, in which each of these items is included in a number of slightly different dimensions. Therefore, depending on the respective requirements, the best combination of these items can be selected so that optimal surgery can be achieved.

According to a further aspect of the invention, there is provided a medical system for removably establishing a spatial orientation between a body implant and a guiding device, specifically between a bone stabilizing implant and a guiding device for anchoring the implant to a internal part of the body. The medical system comprises an adapter device according to a previously described embodiment. The medical system further comprises a positioning arm according to a previously described embodiment.

Also described is a method for removably establishing a spatial orientation between a body implant and a guiding device, particularly between a bone stabilizing implant and a guiding device for anchoring the implant to an internal part of the body. The method comprises the steps of (a) joining a positioning arm and an adapter device so that a positioning arm coupling element engages a fixing element so that the positioning arm engages the adapter device, (b) rotate the positioning arm relative to the adapter device to a final angular position, and (c) engaging a snap mechanism of the positioning arm on a locking member of the adapter device.

This procedure is based on the idea that a surgeon can establish a stable and mechanically reliable contact between the positioning arm and the adapter device by means of a simple movement of his hand. Therefore, it is only necessary to perform a small turning or oscillating movement of the positioning arm relative to the adapter device to enable a mechanical snap-in connection between the positioning arm and the adapter device.

According to a further method, the latching step occurs automatically when the positioning arm approaches the final angular position. This makes it especially easy for a surgeon to establish stable and mechanically reliable contact between the positioning arm and the adapter device, so that no additional hand movement is necessary to provide a firm mechanical connection between the positioning arm. and the adapter device.

According to a further method, the method further comprises the step of locking the snap mechanism by means of a locking device. This method has the advantage that accidental opening of the mechanical connection between the pressure mechanism and the locking element can be avoided in a simple and effective way.

After the medical procedure has been performed using the guiding device the positioning arm can be easily removed from the adapter device and / or the implant simply by removing or simply opening the locking device. Such a medical procedure may comprise, for example, drilling holes in a bone with the aid of a drilling template provided by the guiding device.

According to a further method, the step of locking the snap mechanism comprises rotating a lever. The rotating lever can be integrated into a handle, so that the locking device can be manufactured without requiring additional space. Therefore, the positioning arm does not include sharp edges or corners, which could lead to the risk of the internal tissue of the patient being damaged.

It should be noted that embodiments of the invention have been described with reference to different contents.

The aspects defined above and additional aspects of the present invention are apparent from the exemplary embodiments that will be described below and which are explained with reference to the exemplary embodiments. The invention will be described in more detail below with reference to exemplary embodiments, but the invention is not limited thereto.

Brief description of the figures figs. 1a to 1e show different views of a bone stabilization plate including an integrally formed adapter device;

figs. 2a to 2d show different views of a medical bone stabilization system according to an exemplary embodiment of the invention;

ES 2 344 595 T3 figs. 3a to 3n illustrate the procedure for establishing a strong mechanical connection between the positioning arm and the adapter device.

Detailed description

The illustration in the figures is schematic. It should be noted that, in the different figures, similar or identical elements are provided with the same reference symbols or with reference symbols that are different from the corresponding reference symbols only in the first digit.

As seen in FIG. La, a bone stabilization plate 110 comprises a lower portion 111 and an upper portion 121. The upper portion represents an adapter device 121, which is designed so that a strong mechanical connection can be established between the plate 110 and a positioning arm very easily.

The bone stabilization plate comprises a plurality of openings 112 and a plurality of through holes 113. Openings are formed in plate 111 to decrease the weight of plate 111. Through holes 113 can be used to insert screws (not shown) to secure plate 111 to a bone or bone fragment so that all parts of the bone are attached to the bone stabilization plate 111.

Figure 1b shows an enlarged view of the adapter device 111. The adapter device 111 also comprises some openings 122 and some through holes 123, which can be used for the same purpose as the openings 112 and as the plurality of through holes 113 shown in Figure la, respectively.

The top 121 of plate 111 is bent so that plate 111 can abut against a broken bone along the entire length of the bone, including the end of the bone, eg, the proximal tibia and the distal femur.

The adapter device 121 comprises two fixing elements, a first fixing element 125a and a second fixing element 125b. The two fastening elements are formed as protrusions protruding from a body 126 of the adapter device 111. The adapter device 121 further comprises a locking element 127 that is in the shape of an edge. As will be described below, the fixing elements 125a and 125b and the locking element 127 can provide both a stable three-point bearing and a secure detachable connection between a positioning arm and the plate 111.

Figure 1c shows the two fixing elements 125a and 125b projecting from the body 126 of the adapter device 111.

Figure 1d shows the locking element 127 which, according to the embodiment shown here, is formed in the almost upper section of the plate 110. The edge of the locking element 127 can be described as a recess that is open towards the surface of the plate. contacting the bone of plate 110 and extending inwardly from the edge of the plate and upward toward the upper surface of the plate.

Figure 1e shows a further view of adapter device 121. The two fixation elements 125a and 125b are formed as protrusions protruding from the body 126. The immobilization element 127 is formed as a more or less sharp edge on the outer circumference of the adapter device 111.

The adapter device 121 comprises an asymmetrical shape in which the immobilization element 127 is formed slightly off-center with respect to a longitudinal axis of the bone stabilization plate 111.

Figure 2a shows an overview of a medical system 200 according to one embodiment of the invention. Medical system 200 enables proper treatment of a broken bone by means of bone stabilization plate 210, which comprises a lower portion 211 and an upper portion 221. The upper portion 221 represents the adapter device, which allows a positioning arm 230 to be removably but firmly connected to the plate 210.

The positioning arm 230 comprises a lower portion 241 and an upper portion 231. The lower portion represents a contact portion 241, which is adapted to be removably and firmly connected to the adapter device 221.

The positioning arm 230 further comprises a handle 290. The handle 290 is ergonomically shaped so that the positioning arm 230 can be easily and conveniently moved manually. The handle is equipped with a rotatable lever 295, which is mechanically coupled to a locking device. The locking device will be described later in connection with Figures 3a to 3g.

The upper portion 231 of the positioning arm 230 represents a support for a guide device 280. The guiding device 280 represents a drilling template comprising through holes 283 for precise and easy pre-drilling of holes in a bone fragment, which is located directly below the upper portion 221 of the bone stabilization plate 210. In this way, a minimally invasive and percutaneous surgical technique can be carried out.

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Figure 2b shows an enlarged view of the connection portion between the positioning arm 230 and the adapter device 221. The contact portion 241 of the positioning arm 230 comprises holes 243. These holes 243 represent openings so that a drilling instrument can be inserted through the contact portion 241 to pre-drill holes in a bone fragment located directly across the body. below the adapter device 221. The holes 243 have a diameter that is greater than the diameter of the through holes 123 of the adapter device 121 (see Figure 1b). This enables the screws, which are used to secure the adapter device 221 to the section of bone below the adapter device 221, to pass through the holes 243 formed in the contact portion 241.

At the lower end of the contact portion 241 two coupling elements are provided, a first coupling element 24 5a and a second coupling element, respectively. The second coupling element cannot be seen in the view shown in Figure 2b. According to the embodiment described herein, the coupling elements are formed as two notches, a first notch 245a and a second notch, respectively. The two notches are shaped such that the contact portion 241 of the positioning arm 230 can engage the two a fixation element, the first fixation element 225a and the second fixation element, respectively.

Figure 2c shows a further enlarged view of the connection portion between the contact portion 241 of the positioning arm 230 and the adapter device 221. In this view, the second engagement member 24 5b (second notch) can be seen as it engages the second attachment member 225b (second projection).

Figure 2d shows a top view of the handle 290. A small lever 295 is provided at the top of the handle 290. The lever 295 can rotate in a clockwise direction 295b to immobilize the detachable connection between the adapter device 221. bone stabilization plate 210 and positioning arm 230 representing a mechanical support for guiding device 280. Lever 295 can also be rotated in a counterclockwise direction 295a to release the immobilization device so that arm 230 can be removed from bone stabilization plate 210.

Figures 3a to 3n show a sequence of views illustrating the procedure of establishing a strong mechanical connection between the contact portion 341 of the positioning arm 330 and the coupling device 321. Figures 3a, 3c, 3e, 3g, 3i, 3k and 3m show a general view of the relative orientation between the contact portion 341 and the coupling device 321. Figures 3b, 3d, 3f, 3h, 3j, 3l and 3n each show a corresponding enlarged view.

As can be seen in Figures 3a and 3b, an operator (not shown) moves the contact portion 341 toward the adapter device 321 in a suitable orientation, such that the first notch 345a and the second notch 345b engage the first boss 325a and second boss 325b, respectively. The two projections 325a and 325b project from the body 326 of the adapter device 321.

The positioning arm 330 is provided with a snap mechanism 350, which can rotate relative to a hinge 352 with small angular limits. The snap mechanism 350 is provided with a spring 353, so that the snap mechanism 350 is held in the initial angular position shown in Figure 3a.

Snap mechanism 350 comprises a hook-type element 351, which is integrally formed with snap mechanism 350. The function of the snap mechanism 350 will be described later.

The positioning arm 330 is further provided with a locking device 360. According to the embodiment described herein, the locking device is a rod 360, which is mechanically coupled to the lever 295 shown in Figure 2d. As can be easily seen, the locking rod 360 is capable of engaging the snap mechanism 350 when the locking rod 360 is moved downwardly in contact with the snap mechanism 350. Lock rod 360 is mechanically coupled to lever 295 such that when lever 295 is moved clockwise, lock rod 360 moves downward. When the lever 2 95 is moved counterclockwise, the locking rod 360 moves upward. A person skilled in the art will find various suitable solutions to carry out the mechanical coupling between the lever 295 and the locking rod 360.

The adapter device 321 is provided with the locking element 327 which is in the shape of an edge. As can be easily seen in FIG. 3a, snap mechanism 350 is adapted to engage locking member 327 when contact portion 341 and adapter member 321 abut each other.

To establish a detachable connection between the contact portion 341 and the adapter element 321, the positioning arm 330 is manually moved toward the adapter element 321. This is depicted in Figures 3c and 3d.

As can be seen in Figures 3e and 3f, the contact portion 341 moves further towards the adapter element 321 so that the two notches 345a and 345b engage the two projections 325a and 325b, respectively.

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As can be seen in Figures 3g and 3h, the positioning arm rotates with respect to the hinge around an axis that is defined by the two regions in which the two fixing elements 325a and 325b and the two fixing elements 345a and 345b. coupling abut each other, respectively. In this way, the snap mechanism 350 and the locking element 327 are brought closer to each other. When the hook element 351 of the snap mechanism 350 abuts against an upper side of the locking element 327, the snap mechanism 350 will be displaced to the side.

Figures 3i and 3j show the contact portion 341 and the adapter element 321 when abutting each other. However, the snap mechanism 350 has not yet moved back to its normal position.

Figures 3k and 3l show the contact portion 341 and the adapter element 321, which are fixed together by means of the snap mechanism 350. Due to an elastic force produced by the spring 353, the snap mechanism 350 has moved back to its normal position. Thus, the contact portion 341 and the adapter member 321 are held together by means of a three-point bearing. The three-point bearing includes the connection between the snap mechanism 350 and the locking element 327 and the two regions in which the two fastening elements and the two coupling elements abut each other, respectively. In this way, a precise orientation can be established between plate 210 and guide device 280 (see FIG. 2a).

Figures 3m and 3n show a locked state of the snap mechanism 350. The locked state is characterized in that accidental and unwanted opening of the snap mechanism 350 can be effectively prevented. In this way, the locking rod 360 moves downward so that the lower end of the rod 360 engages the snap mechanism 350.

When the snap mechanism 350 is in the locked state, the bone stabilization plate relative to the adapter device 321, and the guiding device relative to the positioning arm 330 represent a rigid medical system.Therefore, a surgeon can grasp the middle system by handle 390 and plate a broken bone from a patient. The guiding device allows for precise pre-drilling of holes within bone tissue, in which the pre-drilled holes align with predetermined holes in the bone stabilization plate. In this way, the guiding device functions as a drilling template. After pre-drilling has been performed, threaded screws are inserted into the bone tissue to stabilize the bone in its normal position.

After the plate has been fixed in the broken bone, the positioning arm including the guiding device has to be removed from the fixed plate to allow closure of the surgical trauma. The closure usually ends by suturing the patient's skin.

To remove the positioning arm from the bone stabilization plate, the contact portion 341 must be separated from the adapter element 321. Thus, the locking rod 360 must first be moved upward. The positioning arm is then rotated slightly counterclockwise so that the snap mechanism 350 slides out of the locking member 327. Disassembly of contact portion 341 from adapter element 321 can be completed by performing the above-described procedure in reverse order.

It should be noted that the term "comprise" does not exclude other elements or stages and "one" or "one" does not exclude a plurality. The elements described with respect to different embodiments can also be combined. It should also be noted that the reference symbols in the claims should not be construed as limiting the scope of the claims.

Reference symbols list

110 license plate

111 lower portion

112 openings

113 through holes

121 top portion / adapter device

122 opening

123 through holes

125a first fastener / first projection

125b second fastener / second projection

ES 2 344 595 T3

126 device body 121 adapter

127 immobilization element / edge

200 medical system

210 license plate

211 lower portion

221 top portion / adapter device

225a first protrusion / first fastener

225b second projection / second fastener

230 positioning arm

231 upper portion

241 bottom portion / contact portion

243 orifices of contact portion 241

245a first coupling element / first notch

245b second coupling element / second notch

280 guiding device

283 through holes / drilling template

290 handle

295 rotary lever 295a opening direction

295b closing direction

321 top portion / adapter device

325a first fastener / first projection

325b second fastener / second projection

326 adapter device body

327 immobilization element / edge

330 positioning arm

341 bottom portion / contact portion

350 snap mechanism

351 hook element

352 hinge

353 dock

345a first coupling element / first notch 345b second coupling element / second notch

360 locking device / locking rod

390 handle