Mounting assembly for mounting a prosthesis
The present invention relates to a mounting assembly for mounting a prosthesis to a pin and/or implant extending from a patient’s body. The invention particularly relates to the medical field of osseointegration in which a direct interface is formed between an implant and bone, without intervening soft tissue.
In the field of osseointegration, a pin or other implant is implanted into a bone of a limb of the patient to which the prosthesis should be connected to. The pin, which is normally made from metals such as Titanium, integrates into the bone structure. After sufficient integration and fixation, a prosthesis can be attached to the pin.
Mounting assemblies used for mounting a prosthesis to the pin are known in the art. An example of such an assembly is the “Endo Exo Click Safety Adapter” marketed by the company Orthopedic Technology Nijmegen (OTN).
The known assembly comprises a female part and a male part, wherein the female part is configured to be coupled to the prosthesis and the male part to the pin. The mounting assembly further comprises axial locking means for releasably and axially locking the male part and female part relative to each other, and rotational locking means for rotationally locking the male part and female part relative to each other.
In the known system, the male part is first connected to the pin extending from the patient’s body whereas the female part is connected to the prosthesis. As a next step, the male part is inserted into the female part allowing the rotational and axial locking to occur.
Safety of these systems is of the utmost importance. For instance, when a torque is exerted between the male part and the female part, for instance due to a fall, the situation should be avoided in which the osseointegrated pin becomes detached, breaks or periprosthetic bone fractures may occur. Such situation would harm the patient and necessitate an operation to replace the pin.
The rotational locking means of the known system are configured such that once a predetermined torque is exceeded, the rotational lock disengages allowing the male part and the female part to rotate with respect to each other. To this end, the male part is provided with a first engaging element and the female part with a second engaging element. Both elements are fixedly connected to the respective parts. The first engaging element comprises a groove whereas the second engaging element comprises a bar. Under normal conditions, the bar is situated in the center of the groove.
When sufficient torque is exerted, the groove and bar become misaligned and the male part is pushed away in the axial direction from the female part by the bar engaging the slanted wall of the groove. Consequently, the rotational locking is removed and the male part and female part can rotate with respect to each other.
In addition to the rotational locking means, axial locking is obtained using axial locking means that are pre-biased towards a locking position.
The known system suffers from the drawback that it is difficult to ensure that the rotational locking means will disengage when excessive torque is applied, while still being able to guarantee sufficient axial locking during normal use. This is, inter alia, related to the fact that patients may vary greatly in weight.
It is an object of the present invention to provide an assembly in which the abovementioned problems do not occur or at least to a lesser extent.
According to the invention, this object is achieved with an assembly that is characterized in that the rotational locking means comprise a breaking device that is configured to break when an externally applied torque between the male part and female part exceeds a predetermined level thereby allowing the female part and the male part to rotate with respect to each other.
The breaking device of the present invention breaks when excessive torque is applied.
Once the breaking device breaks, rotation is possible between the male part and the female part. In the known system, the male part needed to get disengaged from the female part to allow rotation. To that end, the weight of the patient and the pre-biasing force needed to be overcome. According to the present invention, the weight of the patient is no longer so relevant as the breaking of the breaking device mostly depends on the torque that is exerted and the material strength of the breaking device. This allows a more predictable and reliable operation of the assembly.
The axial locking means can be configured to maintain the axial locking after the breakable device has broken. This prevents the situation where a prosthesis becomes detached from the pin altogether.
In an embodiment, the rotational locking means comprise a first engaging element fixedly connected to one of the male part and the female part, and a second engaging element configured to be releasably coupled to the other of the male part and the female part by means of the breakable device in an rotationally locked manner. The first and second engaging elements are configured to engage each other for the rotational locking. The advantage of using a second engaging element that can be releasably coupled by means of the breakable device is that it prevents damage of the assembly or prosthesis or injury to the patient. By replacing the breakable device, the assembly can once again be used. Moreover, once the breaking device is broken, the rotational locking between the second engaging element and the female part or male part is severed. Even though the first and second engaging elements remain mutually engaged, the male part is able to rotate with respect to the female part. The breaking device and the second engaging element are preferably integrally connected and/or form a single body.
The breakable device may comprise at least one pin that extends from the second engaging element to engage at least one opening in a wall of the other of the male part and the female part.
The pin can be made of materials such as stainless steel. The wall in which the at least opening is arranged is preferably the wall of the female part that is perpendicular to the axial direction.
The at least one pin can be slidably arranged in the at least one opening. Such opening and pin are preferably elongated in the axial direction. If it was not for the axial locking means, the pin could for instance move in axial direction.
The assembly may further comprise a bouncing element made of resilient material arranged in between the second engaging element and the wall, wherein the bouncing element is arranged to dampen axial movement between the male part and the female part related to play in the axial locking means. As locking means suffer from play, mechanical vibrations may be excited during activities such as walking or running. These vibrations may be very disturbing to a patient as they penetrate the body. The bouncing element offers resiliency to dampen these vibrations.
The resilient material may comprise at least one opening corresponding to the at least one opening in the wall, allowing the resilient material to be rotationally locked with respect to the second engaging element by the at least one pin extending through the at least one opening in the resilient material and the corresponding opening(s) in the wall. It may therefore be possible to use for instance a disc of resilient material that is provided with two openings to receive two pins at either side of the disc.
Instead of or in addition to openings, the breakable element may comprise at least two pins that can rotationally lock the resilient material with respect to the second engaging element by engaging side recesses arranged in the resilient material.
The first and second engaging elements may comprise toothed structures.
The ability to change the damping offered by the bouncing element is important to optimize the comfort level of the patient. To that end, an adjustment screw may be arranged through the wall, wherein the adjustment screw is configured to exert an adjustable force, preferably an axial force, onto the second engaging element and/or resilient material to adjust the dampening. Such screw may be used to adjust the properties of the assembly according to the weight of the patient and/or the intended use.
In an embodiment, the first engaging element is connected to the male part. In this case, the second engaging element may a separate component that can be placed into the female part.
The axial locking means may comprise a radial recess in one of the male part and the female part, and a third engaging element engaging the recess and the other of said male part and the female part. For instance, a recess may be provided in the male part and the female part may be provided with a guiding structure, such as a channel, to guide the third engaging element into and out of the recess.
In the case where the first engaging element is connected to the male part, which part also comprises the recess, a sleeve may be arranged around the female part. This sleeve can be configured to axially move between a first position, in which the third engaging element can disengage from the recess in the male part, and a second position in which the sleeve pushes the third engaging element to engage the recess. The sleeve may be pre-biased towards the second position.
When a patient wishes to connect the prosthesis, he can click the prosthesis, which is preferably connected to the female part, onto the male part. In the uncoupled situation, the sleeve will be in the second position. However, when the male part is inserted, the third engaging element will be pushed outwardly by the male part. Once the recess becomes aligned with the third engaging element, the latter will move into engagement with the recess under the influence of the pre-biased sleeve thereby axially locking the male part and the female part. To unlock the male and female part, a patient moves the sleeve towards the first position, in which position the third engaging element can be pushed out of the recess by pulling the male part out of the female part.
The third engaging element may be a bead that is arranged in a channel in a side wall of the female part. Furthermore, the sleeve may comprise an edge on an inner side thereof, which edge is configured to urge the third engaging element towards the recess when the sleeve moves from the first position to the second position.
The channel for the beads may be oriented slightly downward. It should be appreciated by the skilled person, that the angle of inclination of the channel, the shape of the third engaging element, the shape of the tip of the male part, and the shape of the recess, all determine the force required to insert and remove the male part. Preferably, these forces are not equal as it should be easy to insert the male part into the female part, but is should be practically impossible for a patient to remove the male part from the female part without operating the sleeve.
Next, the invention will be described under reference to the accompanying drawings, in which:
Figure 1 illustrates an embodiment of the assembly according to the invention;
Figure 2 shows a cross section corresponding to the assembly of figure 1;
Figure 3 shows a further cross section corresponding to the assembly of figure 1;
Figure 4 illustrates an exploded view corresponding to the assembly of figure 1; and
Figure 5 illustrates the assembly of figure 1, wherein the male part and female part are coupled.
The assembly shown in figure 1 comprises a male part 1 that is connected to a pin 2 that extends from a patient’s body. Here, a cover 3 is shown that protects the skin of the patient. A bolt 4, or other well known means, can be used to connect male part 1 to pin 2. Female part 5 is connected to a prosthesis 6, of which only a part is shown, using screws 7 or the like.
It should be noted that implants other than a pin are not excluded from the present invention.
A sleeve 8 is arranged around female part 5. In addition, a first engaging element 9 is illustrated that comprises toothed structures 10. A recess 11 is provided in male part 1 which will serve to axially lock male part 1 and female part 5 as will be described later.
Now referring to figures 2, 3 and 4, a sealing ring 12 is used for sealing pin 2 with respect to male part 1. A similar ring 13 is placed between sleeve 8 and female part 5.
Female part 5 comprises channels 14 in which metal beads 15 are provided. On an inner side of sleeve 8 an edge 16 is provided. Sleeve 8 is pre-biased by a spring 17 to be in the position shown in figure 2, in which beads 15 extend into female part 5.
When male part 1 and female part 5 are coupled, beads 15 are pushed backwards by male part 1 against the pre-biasing force caused by spring 17. Beads 15 will engage edge 16 and cause sleeve 8 to move downwards slightly. When male part 1 is inserted further, recess 11 becomes aligned with beads 15. The latter will be pushed into recess 11 due to the pre-biasing force. When beads 15 are in recess 11, male part 1 and female part 5 are axially locked, as shown in figure 5.
A second engaging element 18 is shown that can engage first engaging element 9 when male part 1 is placed in female part 5, as shown in figure 5. A breaking device 19 is connected to second engaging element 18, see figures 3 and 4. Here, breaking device 19 comprises a pair of pins. At position 20, the pins are weakened by a stepping in the diameter of the pins. Furthermore, breaking device 19 and second engaging element 18 are an integral component.
A bouncing element 21 made of resilient material is provided in female part 5. It comprises two recesses 22 on an outer edge thereof and a central hole 23. Bouncing element 21 dampens vibrations that are caused by play in the axial locking. For instance, when the patient walks, male part 1 and female part 5 will move slightly with respect to each other. Without bouncing element 21, vibrations would be excited that would penetrate the patient’s body, causing discomfort.
The amount of bouncing can be adjusted using an adjustment screw 24. This screw engages a cover plate 25 that is arranged in between the bottom wall of female part 5 and bouncing element 21. It too comprises recesses 26 on the edge thereof to accommodate the pins of breaking device 19. Second engaging element 18 and breaking device 19, bouncing element 21, and cover plate 25 are not fixedly connected to female part 5. Consequently, in case of a trauma due to which breaking device 19 breaks, a patient only needs to replace breaking device 19.
As shown in figure 5, in the coupled situation, first engaging element 9 and second engaging element 18 are mutually engaging thereby rotationally locking male part 1 and female part 5. Rotation between male part 1 and female part 5 is prevented because the pins of breaking device 19 extend into openings in the bottom wall of female part 5.
In the embodiment shown in figure 3, the pins of breaking device 19 extend parallel to male part 1. In other embodiments, the pins could extend perpendicular to male part 1 into openings that are arranged in a radial direction into the side walls of female part 5.
When a predetermined amount of torque is exerted between male part 1 and female part 5, pins of breaking device 19 will break, normally at position 20. This will release the rotational locking, as first engaging element 9 and second engaging element 18 can rotate together as the latter is no longer coupled to the bottom wall of female part 5 by breaking device 19. It is important to note that this rotation is possible while still maintaining the axial locking. When a patient suffers a trauma, causing the predetermined amount of torque to be exceeded, the male part 1 and female part 5 are allowed to rotate with respect to each other, thereby preventing any damage to the osseointegrated pin. Furthermore, the prosthesis will not become detached from the patient’s body due to the axial locking that is still in place.
The amount of torque that is required to break the pins of breaking device 19 is mainly determined by the stepping in diameter at position 20. Consequently, different breaking devices 19 can be used depending on the intended use or other parameters such as a patient’s weight or activity level.
It should be apparent to the skilled person that other embodiments are possible without departing from the scope of the invention which is defined by the appended claims.