• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to a device (1) for assisting the insertion of an orthopedic instrument (2) intended to be inserted at the level of a receiving bone (3) by impaction, by means of an impactor (10). ) having at least one striking surface (11) adapted to contact an impact surface coupled to said orthopedic instrument for applying an impaction force to said orthopedic instrument (2), said device being characterized in that it comprises a force sensor (12) able to measure, at each impact, said impaction force applied by the impactor (10) on said impact surface and to provide a measurement signal indicative of the temporal variation of said force applied impaction means, said force sensor (12) being connected to processing means (30) designed to determine, from the temporal variation of said impaction force supplied for each impact successively, an indicator representative of the degree of 'in sertion of said orthopedic instrument (2) in the receiving bone (3).
    公开号:FR3019031A1
    申请号:FR1452677
    申请日:2014-03-27
    公开日:2015-10-02
    发明作者:Guillaume Haiat；Vincent Mathieu；Adrien Michel
    申请人:Centre National de la Recherche Scientifique CNRS；
    IPC主号:
    专利说明:

    [0001] The invention relates to a device for assisting the placement of an orthopedic instrument, intended to be inserted at a receptor bone by impaction by means of an orthopedic instrument. a percussion tool, or impactor, capable of applying an impaction force to said orthopedic instrument. The term "orthopedic instrument" denotes the set of implants for orthopedic prostheses intended to be implanted at the level of the bone tissue in order to proceed to the replacement of the deficient joints, but also the ancillary devices used to prepare the receiving bone in order to allow the placement of the definitive implant and, in particular, orthopedic implant surgical graters. Among the orthopedic prostheses, the available implants are multiple. In particular, it is possible to distinguish total hip prostheses, knee prostheses, shoulder prostheses or ankle or spine elbow prostheses. One field of application of the present invention relates primarily, but not exclusively, to the placement of orthopedic instruments for hip prostheses. The vast majority of the proposed models of hip prosthesis have in common a first part, consisting of a femoral stem intended to be implanted in the medullary canal of the femur and a prosthetic head formed of an optionally removable spherical piece replacing the head of the femur, and a second part, consisting of a prosthetic acetabulum, intended to be implanted in the cotyloid cavity located at the lateral face of the iliac bone. The prosthetic acetabulum, which is therefore intended to replace the articular part of the pelvis, is more precisely constituted of an acetabular cup, which is an approximately hemispherical piece, generally made of metal, implanted in the pelvic bone and in which a insert with which the prosthetic head is articulated. In particular, the introduction of the prosthetic acetabulum into the bone cavity can be performed by simple impaction, by means of an ancillary laying provided for this purpose, through which the prosthetic acetabulum is impacted by the surgeon, at the same time. help of an impactor, typically a hammer, coming to strike the ancillary pose. An example of an ancillary prosthetic acetabular prosthesis consists of a rigid manipulation handle, provided in its distal part, with a gripping head, allowing the gripping and then positioning of the acetabulum to the impaction location of the acetabulum. in the bone cavity of the hip and, in its proximal part, an impact surface intended to be impacted by means of an impact face of the impactor provided for this purpose to apply the impaction force necessary to placement of the prosthetic acetabulum in the bone cavity. Surgical success during the placement of the prosthetic acetabulum and, more generally, an orthopedic prosthesis implant intended to be implanted by impaction, is based on a sufficient degree of insertion of this implant into the receiving bone, the Biomechanical stability will depend. This biomechanical stability is actually determined by two distinct phenomena: - the primary stability, which corresponds to the degree of attachment or anchoring of the prosthesis element in the bone just after the operation (immediate postoperative stability) , and which depends on the bone quality and the surgical procedure, which will be detailed below; secondary stability, which corresponds to bone regrowth via osseointegration phenomena, and which depends on the primary stability and the ability of the bone to heal. Following the conventional surgical procedure, the surgeon conducts a hole in the pelvic bone, so as to make a hemispherical cavity allowing holding of the implant, while stimulating the bone remodeling phenomena, which improves the osseointegration phenomena during the healing phase. Once the cavity is completed, the surgeon inserts the prosthetic acetabulum forcefully into the cavity by impaction, using the impactor and the ancillary pose, until he judges that a degree of sufficient insertion of the implant is achieved so as to obtain a good primary stability of the implant and without causing fractures in the bone. Primary stability is indeed an essential element for surgical success. Typically, a good primary stability corresponds to a laying situation in which the degree of insertion of the implant is optimal, resulting in a maximum contact area between the bone and the implant. However, it is now difficult for the surgeon to be able to finely quantify the number and the force of the impacts to be generated by means of the impactor on the installation ancillary, which are necessary to obtain good primary stability. , without damaging the receiving bone. A compromise must thus be found between a sufficiently high impact energy, so as to obtain a good primary stability, which corresponds to a maximum contact area between the bone and the implant, and a sufficiently low impact energy , so as not to risk intraoperative fractures of the receiving bone. Today, however, only empirical methods are used. Typically, during the operation, surgeons rely on their experience and, in particular, on the sound of the impact to determine whether they should hit harder or harder and / or continue to apply hammer blows. However, using this type of method, surgeons can not rely on the absolute certainty that the degree of insertion of the implant into the receiving bone is optimal. In addition, one of the disadvantages residing in the application of this method is that when the implant is insufficiently inserted into the bone, it may result in a separation of the latter to its support. This can result in significant lesions of the cavity dug at the receiving bone. In this case, the surgeon will then for example make a new intervention to expand the bone cavity, which will then allow the positioning of a new implant with appropriate dimensions. Patent document EP1433445 discloses a method for the intraoperative measurement of the mechanical stability of an orthopedic prosthesis intended to be implanted in a bone by forced insertion, intended to help the surgeon to estimate the implant stability. This method consists in measuring a relative sliding of the prosthesis relative to the receiving bone under the action of a suitably predetermined test load, applied to the prosthesis or to the receiving bone. This method relies however on a complex implementation. In addition, this identified need to be able to finely assess the number of impacts necessary to achieve a sufficient degree of insertion without risking causing intraoperative fractures of the receiving bone, is also found during the implementation of the surgical procedure of impacting an orthopedic surgical grater, in particular a femoral graft for a hip prosthesis. Indeed, this type of rasp is conventionally used to make a hole in the medullary canal of the femur by "milling" the bone so as, on the one hand, to prepare the shape of the canal for the implant to adapt to it perfectly and, on the other hand, to stimulate bone regrowth by removing bone tissue superficially. These orthopedic graters are not an element of the implant (such as the acetabulum or the femoral stem) since they are removed after having impacted, so as to allow the installation of the final implant. However, the implementation principle is similar insofar as it involves directly impacting the grater with the impactor (without the intermediary of an ancillary) until reaching a sufficient degree of insertion taking care of not not cause fracture of the receiving bone into which the rasp is inserted. In this context, an aim of the present invention is to propose a device for assisting the placement of an orthopedic instrument in a receiving bone, which makes it possible to provide an accurate evaluation of the degree of insertion of the orthopedic instrument. in the receiving bone during the operation, offering the surgeon a real decision-making tool capable of informing him in real time, in particular on the primary stability of orthopedic implants, while being easy to use and to artwork. To this end, the invention relates to a device for assisting the placement of an orthopedic instrument intended to be inserted at a receiving bone by impaction, said device comprising an impactor comprising at least one adapted striking surface. to impact an impact surface coupled to said orthopedic instrument to apply an impaction force to said orthopedic instrument. According to the invention, said impact surface of said impactor is equipped with a force sensor able to measure, at each impact, said impaction force applied by the impactor on said impact surface and to provide a signal of indicative measure of the temporal variation of said applied impaction force, said force sensor being connected to processing means designed to determine, from the temporal variation of said impaction force provided for each impact successively, a representative indicator the degree of insertion of said orthopedic instrument into the recipient bone.
    [0002] The invention is therefore based on the implementation of a simple force sensor at the impact surface of the impactor, delivering measurement signals able to reflect the temporal variation of the force applied for each impact successively, of which the recording and analysis will make it possible to determine an indicator revealing the rigidity of the bone-orthopedic instrument contact and thus the degree of insertion of the orthopedic instrument into the receiving bone. The device of the invention thus provides information, in real time, the surgeon on the degree of insertion achieved during the insertion of the orthopedic instrument in the receiving bone. In addition, in addition to its reduced cost, the device of the invention is particularly simple to use and advantageously does not modify in any way the surgical procedure of the surgeon. Advantageously, said indicator is determined by said processing means as being the average of said applied impaction force, calculated on a time window of programmable duration positioned on said measurement signal, the start time of said time window being defined by report at a time corresponding to the maximum amplitude of said measurement signal. It could be shown that the indicator thus constructed is correlated with the tearing force, that is to say the force required to apply to pull the orthopedic instrument from its anchorage in the receiving bone. In other words, the indicator thus constructed provides an evaluation of the tearing force, which is a determining factor of implant stability. According to a first embodiment, the start time of said time window coincides with the instant corresponding to the maximum amplitude of said measurement signal. Preferably, according to this first embodiment, said time window has a duration of between 1.2 ms and 2 ms, advantageously between 1.4 ms and 1.8 ms and advantageously still equal to 1.6 ms.
    [0003] According to a second embodiment, the start time of said time window is defined with a predetermined delay with respect to the instant corresponding to the maximum amplitude of said measurement signal. Preferably, according to this second embodiment, said time window has a predefined duration of less than 10 ms.
    [0004] Preferably, said indicator is calculated as follows: t2 / 1 = Ai - (t2 o _ f where: A (t) corresponds to the amplitude of said measurement signal at time t, Al corresponds to the amplitude said t1 and t2 respectively correspond to the start and end times of said time window As a variant, said indicator is determined by said processing means as being the duration of impact measured from said temporal variation. .
    [0005] Advantageously, said processing means comprise means for controlling the convergence of said indicator towards a stationary value of said indicator as a function of the number of impacts so as to evaluate said degree of insertion of said orthopedic instrument into the receiving bone. According to one embodiment, said processing means of the invention are designed to detect when said indicator reaches a saturation plateau, indicating that said degree of insertion is sufficient. Indeed, the attainment by the indicator of a substantially stable bearing from a certain number of impacts, means that the stiffness of the contact between the orthopedic instrument and the receiving bone no longer varies, whereby the degree of insertion is considered optimal or, in any case, sufficient. As a variant, the processing means can also compare the value of the indicator with a threshold value defined using charts. Advantageously, said processing means are coupled to sound and / or visual warning means capable of providing a visual and / or audible indication when the degree of insertion of said orthopedic instrument into the receiving bone evaluated by said processing means is sufficient. Said orthopedic instrument may consist of an implant for an orthopedic prosthesis, said impactor then acting to impact said implant in cooperation with an anchoring instrument consisting of a rigid manipulation handle, provided in its distal portion, with a gripping head of said implant and, in its proximal portion, said impact surface. Said orthopedic instrument may also consist of an orthopedic implant surgical rasp, in particular a hip prosthesis femoral rasp, comprising a gripping portion provided at its upper end with said impact surface. The invention also relates to a method of processing a signal representative of an impaction force applied by means of an impact surface of an impactor on an impact surface coupled to an orthopedic instrument for insertion into a level of a receiver bone by impaction, said method comprising steps in which: by means of a force sensor equipping said striking surface of said impactor, a measurement signal indicative of the temporal variation of said force is collected; impaction applied by the impactor on said impact surface during each impact, from the temporal variation of said impaction force provided for each impact successively, an indicator representative of a degree of insertion of said instrument is determined; orthopedic in the receiving bone.
    [0006] The method advantageously comprises a step of controlling the evolution of said indicator as a function of the number of impacts in which the convergence of said indicator is monitored towards a stationary value of said indicator as a function of the number of impacts so as to evaluate said degree of inserting said orthopedic instrument into the receiving bone.
    [0007] The method preferably comprises a step of controlling audible and / or visual warning means when said indicator reaches said stationary value or a threshold value defined previously by charts. The method described above can be implemented by digital processing means, for example a microprocessor, a microcontroller or other. Other features and advantages of the invention will emerge clearly from the description which is given below of a particular embodiment of the invention presented by way of indication and in no way limiting, with reference to the appended drawings, in which: - Figure 1 is a schematic representation of a device for assisting the establishment of an orthopedic prosthesis implant according to the invention; FIG. 2 is a diagram illustrating an example of six measurement signals corresponding to the variation of the force applied to the anchoring tool as a function of time during different impacts and illustrating the calculation of an indicator representative of the degree of inserting the implant into the receiver bone corresponding to the average of the calculated signal over a predefined integration time window; - Figure 3 is a diagram illustrating another embodiment for the positioning of the integration time window used to calculate the indicator according to the invention; FIG. 4 is a diagram illustrating an example of two measurement signals corresponding to the variation of the force applied to the anchoring tool as a function of time during different impacts and illustrating the calculation of the indicator representative of the degree of inserting the implant into the recipient bone according to an alternative embodiment; - Figure 5 is a diagram illustrating the variation of the indicator according to one or the other of the two variants depending on the number of impacts.
    [0008] FIG. 1 shows a device 1 for assisting the placement of an orthopedic instrument 2, which consists in this example of an implant for an orthopedic prosthesis and in particular a prosthetic acetabulum 2 intended for be inserted progressively by impaction in a receiving bone 3, formed by a bone cavity of the hip 4 of the patient. The device 1 comprises a percussion tool or impactor 10, of the hammer or equivalent type, used by the surgeon to produce an impact on the prosthetic acetabulum 2 by means of an ancillary device 20 for the prosthetic acetabular cup 2. The ancillary laying 20 essentially comprises a handle comprising a rigid rod 21 at the proximal end of which is rigidly fixed a knob having a substantially convex surface 22, forming an impact surface. By traversing the rod 21 from its proximal end towards its distal end, the rod 21 also comprises a handling handle 24 integral with the rod 21, then a section 25 terminating in a head 26 for grasping the prosthetic acetabulum 2, not illustrated in FIG. detail.
    [0009] The impactor 10 comprises a striking surface 11 intended to impact the impact surface 22 of the anchoring device 20, to apply the impaction force necessary for the implementation of the implant 2 in the bone cavity 3. Several impacts of substantially the same intensity are preferably performed by means of the impactor so as to obtain a progressive depression of the orthopedic instrument, in this case the prosthetic acetabulum, in the receiving bone. In addition, the direction of the impaction force is substantially aligned along the axis of the implant. As explained above, the invention also applies to the establishment of an orthopedic instrument-type orthopedic implant surgical rasp, including a femoral rasp for hip prosthesis. In this case, the rasp is intended to be impacted directly by the impactor 10, preferably with substantially the same intensity, without the intermediary of an ancillary laying, and the corresponding impact surface is then constituted by a surface provided for this purpose, arranged at an upper end of a gripping portion of the rasp. According to the embodiment of Figure 1, the impactor 10 is equipped with a force sensor 12, adapted to be positioned on the striking surface 11 intended to come into contact with the impact surface 22 of the This force sensor 12 is intended to convert into an exploitable electrical signal, the impaction force applied to the impact surface 22 of the anchoring device during each strike by means of the impactor 10 for the insertion of the implant 2 into the bone cavity 3. It is for example designed using strain gauges or strain gauges disposed at the striking face 11 of the percussion tool 10 and connected according to a mounting appropriate. According to another embodiment (not shown), the force sensor 12 can be positioned at the impact surface 22 of the anchoring device 20 (or the orthopedic instrument itself, in the case of impaction placement of an orthopedic grater). Furthermore, the device of the invention comprises processing means 30, coupled to the force sensor 12, and arranged, as will be described in more detail later, to evaluate the degree of insertion of the implant 2 to the the level of the receiving bone 3, from the measurement signals delivered by the force sensor 12. These processing means 30, such as a microprocessor, are associated with a memory 31 intended to record the measurement signals supplied by the force sensor 12, the processing means 30 and the memory 31 being for example assembled on a printed circuit. The processing means 30 are for example housed in an outer casing 32. In a variant, the treatment means 30 can also be integrated into the device that is equipped with the force sensor (impactor, ancillary set, or orthopedic instrument in the case of a rasp, according to the different embodiments). Preferably, the connection between the force sensor 12 and the processing means 30 is made wired by means of a cable. In another variant, the transmission of the measurement signals acquired by the force sensor 12 could also be made by means of a wireless link. With reference to FIG. 1, during each strike with substantially the same intensity carried out by means of the impactor 10 on the anchoring tool 20, the force sensor 12 is designed to record the impaction force applied in dynamic mode. . More specifically, during each successive strike required by the introduction of the prosthetic acetabulum, the force sensor 12 is able to provide a measurement signal indicative of the temporal variation of said applied impaction force. Thus, as illustrated in FIG. 2, the processing means 30 have for each impact a signal of the temporal variation of the applied impaction force. FIG. 2 shows, by way of example, six such measurement signals, corresponding to the temporal variation of the applied impaction force, during different impacts, respectively the first, the second, the third, the fourth, the sixth and the tenth impact performed during an insertion test of the prosthetic acetabulum in a recipient bone. This test was carried out using as an impactor, the same mass of 3.5 kg released on the impact surface of the anchoring tool from a height of 4 cm, so as to reproduce impacts of substantially the same intensity for the duration of the insertion test. As shown in Figure 2, the profile of the temporal variation of the impaction force applied by the impactor on the anchoring tool varies greatly depending on the rank of the impact. However, it has been demonstrated that this temporal variation in the impact force applied during an impact with substantially the same intensity depends directly on the rigidity of the contact between the implant and the receiving bone, as well as on the strength of the force. pullout. Also, the invention is based on the measurement of the temporal variation of the impaction force between the impact surface of the anchoring tool and the impact surface of the impactor to determine an indicator capable of qualifying this state of rigidity of the contact between the implant and the receiving bone and thus the degree of insertion of the implant into the receiving bone and the tearing force. Indeed, the increase in the degree of insertion of the implant into the receiving bone is related to the increase of the contact surface between the implant and the receiving bone, which induces an increase in the stiffness of the contact. between the implant and the bone, which can advantageously be revealed by the analysis of the temporal variation of the impaction force between the anchoring tool and the impactor. A first variant making it possible to construct such an indicator by means of the processing means of the invention consists in determining the average of the impaction force applied, at each impact, calculated over a time window of programmable duration positioned on the measurement signal supplied by the sensor, the beginning of this time window being preferentially defined with respect to an instant corresponding to the maximum amplitude of the measurement signal. In other words, the time window makes it possible to integrate the measurement signal corresponding to the temporal variation of the impaction force in a programmable period of time. According to a first embodiment, with reference to FIG. 2, during the processing of the measurement signal resulting from each impact, the start time t1 of the integration time window F, or the low integration limit, is defined in such a way that it coincides with the instant to correspond to the maximum amplitude A1 of the measurement signal. Indeed, the shape and amplitude of the peak corresponding to the maximum amplitude is characteristic for each acquired measurement signal, which makes it a common reference point easily reproducible for the low integration limit of the signal. According to this embodiment, the integration time window therefore starts at the instant corresponding to the maximum amplitude A1 of the measurement signal. According to this first embodiment, the end time t 2 of the time window F for integrating the measurement signal, or the high integration limit, is chosen such that the integration time window F has a duration of between 1.2 ms and 2 ms, advantageously between 1.4 ms and 1.8 ms and preferably equal to 1.6 ms. FIG. 3 illustrates another embodiment for defining the position and the duration of the integration time window allowing the construction of the indicator according to the invention. FIG. 3 illustrates the results of a series of tests for insertion of a prosthetic acetabulum into receiving bones of different diameters, respectively 49, 49.5, 50, 50.5 and 51 mm, again with impacts of substantially the same intensity, and FIG. 3 more precisely illustrates the different temporal variation signals of the impaction force applied by the impactor on the anchoring tool during the last impact of each test series, for the five receiving bones of different diameters, respectively. 49, 49.5, 50, 50.5 and 51 mm. In particular, according to this other embodiment for the positioning of the integration time window F, the start time t i of the integration time window F, in other words the low integration limit of the measurement signal, is defined with a predetermined delay with respect to the instant to correspond to the maximum amplitude A1 of the measurement signal. For example, the limits of the integration time window F are chosen as follows: t1 = to + 0.391ms and t2 = to + 0.527ms. It has been found that the calculation of the average of the signal on such an integration time window was appropriate for obtaining a reliable and relevant indicator of the degree of insertion of the implant and therefore of the stability of that -this. However, the integration time window F may have its duration substantially modified, without substantially affecting the results, and may preferably have a predefined duration of less than or equal to 10 ms. It may for example be between 0.080 ms and 0.2 ms, advantageously between 0.098 ms and 1.175 ms. Once the integration time window F is positioned according to one or other of the embodiments described above, the indicator Ii representative of the degree of insertion of the implant into the receiving bone can be calculated from the following way: 1 t2 Il = Al. (_ ti) f A (t) .dt t2 where: A (t) corresponds to the amplitude of said measurement signal at time t; Al corresponds to the maximum amplitude of said measurement signal; and t1 and t2 correspond respectively to the start and end times of said integration time window F. Advantageously, the value of this indicator is correlated to the tearing force, so that its value thus calculated makes it possible to provide a measurement of the tearing force of the implant and thus of the mechanical stability of the implant. According to a second variant embodiment, an indicator 12 representative of the degree of insertion of the implant into the receiving bone can also be determined by the processing means as being the duration of impact measured from the temporal variation of the impaction force applied for each impact. Indeed, an increase in the contact area between the implant and the bone during the insertion of the implant into the bone induces an increase in the rigidity of the contact between the implant and the bone. which results in a decrease in the duration of impact during successive impacts. In other words, the duration of impact, during which the force is transmitted from the percussion tool to the anchoring instrument, is indicative of the rigidity of the bone-implant contact and therefore the degree of insertion of the implant. in the recipient bone, on which the primary stability of the implant depends.
    [0010] Also, this variant of the calculation of the indicator I2 is based on the observation that the duration of impact, at each impact, is able to constitute relevant information to characterize reliably and accurately the mechanical properties of the bone-implant interface and hence the rigidity of the bone-implant contact.
    [0011] Thus, according to this variant, during each impact during insertion of the implant (with substantially the same intensity), the force sensor 12 provides a measurement signal indicative of the temporal variation of the applied impaction force and the duration of each impact is calculated from the temporal variation of the impaction force applied to construct an indicator 12 representative of the degree of insertion of the implant as explained above. FIG. 4 illustrates two such signals recorded by the force sensor during two different impacts, in the test conditions exposed with reference to FIG. 2. The signal in dashed lines corresponds to the signal collected during the third impact and the signal in solid lines. corresponds to the signal collected during the sixth impact. According to one embodiment, the instants t'1, t "1 (respectively the instants t'2, t" 2) corresponding to the beginning (respectively the end) of the impact for each of these signals, have been calculated by determining the lower time limit (respectively the upper time limit) for each impact where the amplitude of the applied impaction force is greater than a predefined threshold value, for example 30N. This then results in the indicator 12 corresponding to the duration of the time window bounded by these two lower and upper time limits, calculated as follows: 12 = t'2 - t'1, ie 12 = 4.5 ms for the signal corresponding to the third impact and 12 = t "2 - t" 1, ie 12 = 3.5 ms for the signal corresponding to the sixth impact. Whatever the variant embodiment chosen for the construction of the indicator 11 or 12 representative of the degree of insertion of the implant into the receiving bone, the processing means 30 are then designed to control the evolution of the indicator according to the number of impacts, in order to evaluate, from this evolution, the degree of insertion of the implant into the bone and consequently, the primary stability of the implant. The signals shown in FIG. 2 correspond to the signals of rank 1, 2, 3, 4, 6 and 10 collected during the insertion test of the prosthetic acetabulum into a receiving bone under the conditions described above with reference to FIG. 2 Figure 5 shows the corresponding variations of the two indicators Ii and 12 as a function of the number of impacts. It is noted that the indicator Ii increases during the first six strikes and then reaches a plateau from the sixth impact where its value does not change significantly anymore. Regarding the indicator 12 corresponding to the duration of impact, it is noted that it varies only very slightly after the third impact, while the overall shape of the signals continues to evolve until the sixth impact. After the sixth impact, the signals are almost superimposed, leading to substantially constant values for the two indicators, respectively Ii e112.
    [0012] Also, in order to determine the degree of insertion of the implant into the receiving bone, the processing means comprise means for controlling the convergence of the indicator Ii or 12 towards a stationary value as a function of the number of impacts. . Also, the processing means of the invention are for example designed to detect when the indicator reaches a plateau of saturation, where its value does not change significantly anymore, thereby indicating that the degree of insertion of the implant in the receiving bone is sufficient. Indeed, the achievement by the indicator of a substantially stable bearing from a number of impacts means that the rigidity of the contact between the implant and the receiving bone during the insertion process does not vary. plus, whereby the degree of insertion is considered optimal or, in any case, sufficient. The value of the indicator, correlated to the tearing force, is also taken into account by the processing means to determine the implant stability. This behavior can be explained by the fact that the implant gradually sinks into the receiving bone during a first phase of the impacts. Thus, the bone surface in contact with the orthopedic instrument increases, which induces an increase in the rigidity of the contact resulting in an evolution of the indicator, in particular by an increase of the latter according to the variant where it measures from the temporal variation of the applied force, the mean of the force over a predefined integration time window, or by a decrease of the latter according to the variant where it measures, from the temporal variation of the applied force , the duration of impact. After a number of impacts (six in the example of Figure 5), the indicator reaches a plateau because the implant is fully embedded in the bone and the contact surface between the bone and the bone. The orthopedic instrument can therefore no longer increase, which explains the plateau reached by the indicator according to the invention. In other words, the measurement principle of the indicator according to the invention is based on an estimation of the rigidity of the orthopedic bone-instrument contact, whereby the degree of insertion of the implant into the receiving bone can be evaluated. Other approaches than the one just described could also be envisaged to evaluate the degree of insertion from the measurement signals recorded by the force sensor. Nevertheless, whatever the approach chosen, the basic principle of the invention, on which the processing of the measurement signals acquired by the force sensor for the evaluation of the degree of insertion is based, is to use the variation of the impaction force applied as a function of time for each strike or, alternatively, to use the Fourier transform of the variation of the impaction force as a function of time (frequency domain). According to the foregoing, it is therefore considered that the degree of insertion of the implant into the receiving bone is sufficient as soon as the processing means 30 detect that the indicator Ii or 12 has reached a stable saturation plateau, meaning that the rigidity of the bone-implant contact no longer varies.
    [0013] Alternatively, it can also be considered that the degree of insertion of the implant is sufficient when the processing means 30 detect that the indicator has reached a predetermined threshold value, using charts. The processing means may also be coupled to sound and / or visual warning means 33, able to provide a visual and / or audible indication to the surgeon when the primary stability evaluated by the processing means is considered sufficient, in other words as soon as the indicator reaches a plateau. Therefore, the surgeon has real-time reliable information indicating that he has reached a sufficient degree of insertion of the implant into the receiving bone and that it is no longer necessary to continue to impact the implant. implant, thus avoiding any risk of causing a fracture of the receiving bone. An application of the device and the method which have just been described relates to the implantation of hip prosthesis implant, with the particular example of the prosthetic acetabular fitting. Of course, still in the context of the total hip prosthesis, the invention could also apply to the installation of the femoral stem. In addition, other applications of the present invention in the context of orthopedic surgery are also conceivable, which relate to the placement of implants for knee, shoulder or ankle prostheses and, in general, the implementation of place of any type of orthopedic instrument requiring to be inserted in a bone receptor by impaction.
    权利要求:
    Claims (10)
    [0001]
    REVENDICATIONS1. Device (1) for assisting the insertion of an orthopedic instrument (2) intended to be inserted at the level of a receiving bone (3) by impaction, said device comprising an impactor (10) comprising at least one surface impact device (1 1) adapted to impact an impact surface coupled to said orthopedic instrument for applying an impaction force to said orthopedic instrument (2), said device being characterized in that said impact surface of said impactor is equipped with a force sensor (12) able to measure, at each impact, said impaction force applied by the impactor (10) on said impact surface and to provide a measurement signal indicative of the temporal variation of said force applied impaction means, said force sensor (12) being connected to processing means (30) designed to determine, from the temporal variation of said impaction force provided for each impact successively, an indicat eur (Ii) representative of the degree of insertion of said orthopedic instrument (2) in the receiving bone (3).
    [0002]
    2. Device according to claim 1, characterized in that said indicator (Ii) is determined by said processing means as being the average of said applied impaction force, calculated on a time window (F) of programmable duration positioned on said measurement signal, the beginning of said time window being defined with respect to an instant (to) corresponding to the maximum amplitude (Ai) of said measurement signal.
    [0003]
    3. Device according to claim 2, characterized in that the start time (ti) of said time window (F) coincides with the instant (to) corresponding to the maximum amplitude of said measurement signal.
    [0004]
    4. Device according to claim 2 or 3, characterized in that said time window (F) has a duration between 1.2 ms and 2 ms.
    [0005]
    5. Device according to claim 2, characterized in that the start time (t1) of said time window (F) is defined with a predetermined delay with respect to the moment (to) corresponding to the maximum amplitude (Ai). ) of said measurement signal.
    [0006]
    6. Device according to claim 5, characterized in that said time window (F) has a predefined duration less than or equal to 10 ms.
    [0007]
    7. Device according to any one of claims 2 to 6, characterized in that said indicator (Ii) is calculated as follows: 1 t2 Il = - 0 71. A (t) .dt Ap (t2 where: A (t) corresponds to the amplitude of said measurement signal at time t, Al corresponds to the maximum amplitude of said measurement signal, and t1 and t2 correspond respectively to the start and end times of said time window.
    [0008]
    8. Device according to any one of the preceding claims, characterized in that said processing means (30) comprise means for controlling the convergence of said indicator to a stationary value of said indicator as a function of the number of impacts, so as to evaluating said insertion degree of said orthopedic instrument (2) in the receiving bone (3).
    [0009]
    9. Device according to any one of the preceding claims, characterized in that said orthopedic instrument (2) consists of an implant for orthopedic prosthesis, said impactor (10) acting to impact said implant in cooperation with an ancillary application ( 20) consisting of a rigid handle (21) for manipulation, provided in its distal portion, a gripping head (26) of said implant (2) and, in its proximal portion, said impact surface (23).
    [0010]
    10. Device according to any one of claims 1 to 7, characterized in that said orthopedic instrument (2) consists of an orthopedic implant surgical rasp, in particular a femoral rasp for hip prosthesis, comprising a gripping portion. provided at its upper end with said impact surface.
    类似技术:
    公开号 | 公开日 | 专利标题
    EP2923677B1|2016-11-09|Device for assisting with the placement of an orthopaedic instrument
    US10426541B2|2019-10-01|Device for assisting with the placement of an orthopedic instrument
    US20180256343A1|2018-09-13|Method and apparatus for protecting modular implant connection
    US20020116007A1|2002-08-22|Method and apparatus for removing an acetabular cup
    FR2839878A1|2003-11-28|Preparation of a femur bone, for a press fit prosthesis without cement, a modular rasp is used with a standard distal section and a variety of proximal sections for selection, used with a neutral linear gauge and scale markings
    US8348953B2|2013-01-08|Method and apparatus for impacting bone material
    EP3260088A1|2017-12-27|System for monitoring by-impaction assembly between a prosthetic component and a support member, and surgical kits including such a system
    EP1360949A1|2003-11-12|New total hip prosthesis
    FR2770128A1|1999-04-30|Hip joint prosthesis and fitting tool
    EP3687459B1|2021-08-04|Device for inserting a surgical implant
    EP3687458A1|2020-08-05|Device for inserting a surgical implant
    US20140081278A1|2014-03-20|Acetabular cup inserter handle
    FR3016282A1|2015-07-17|PROSTHESIS IMPACTION SYSTEM, IN PARTICULAR FOR PYROCARBON IMPLANTS
    WO2015114244A1|2015-08-06|Device and method for ultrasonic inspection of bone quality
    KR102376082B1|2022-03-18|Tools and methods for removing an acetabular ball from an acetabular cup in a hip replacement prosthesis
    EP2097047B1|2010-05-19|Surgical instrument for simulating, in the intraoperative phase, the functioning instability of acetabular components of hip prostheses
    FR3084464A1|2020-01-31|DEVICE FOR EVALUATING THE STRENGTH OF A MATERIAL
    FR3022766A1|2016-01-01|PACKAGING STRUCTURE OF COTYLOID IMPLANTS AND INSTALLATION INSTRUMENTS THEREOF
    Aguas et al.2013|A Novel Technique to Remove Bone Cement in Reoperative Revision Knee Arthroplasty
    EP1741411A1|2007-01-10|Set of femoral prothesis for the first application and device for preparing the femur.
    同族专利:
    公开号 | 公开日
    FR3019031B1|2016-04-15|
    EP2923677A1|2015-09-30|
    EP2923677B1|2016-11-09|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US20050101962A1|2003-11-10|2005-05-12|Thorsten Schwenke|Servo-controlled impacting device for orthopedic implants|
    WO2007070287A2|2005-12-09|2007-06-21|The General Hospital Corporation|Implant insertion device|
    DE102006030343A1|2006-06-30|2008-04-30|Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.|Device for implantation of prosthesis in bone in type of hand-held unit, has motorized striking unit, which stays in connection with clamping chuck|
    WO2009105817A1|2008-02-29|2009-09-03|Silesco Pty Ltd|An orthopaedic safety system|WO2019063673A1|2017-09-29|2019-04-04|Centre National De La Recherche Scientifique|Device for inserting a surgical implant|
    WO2019063675A1|2017-09-29|2019-04-04|Centre National De La Recherche Scientifique|Device for inserting a surgical implant|EP1433445B1|2002-12-11|2005-05-04|Universita Degli Studi Di Bologna|Apparatus for intraoperative measurement of the mechanical stability of an endoprosthesis implanted in a bone|WO2019100148A1|2017-11-21|2019-05-31|Ossimtech Inc.|Impactor mechanism for virtual reality surgery simulation system and telesurgery|
    FR3084464B1|2018-07-26|2021-02-26|Centre Nat Rech Scient|DEVICE FOR EVALUATING THE STRENGTH OF A MATERIAL|
    法律状态:
    2015-03-19| PLFP| Fee payment|Year of fee payment: 2 |
    2016-02-19| PLFP| Fee payment|Year of fee payment: 3 |
    2017-02-21| PLFP| Fee payment|Year of fee payment: 4 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1452677A|FR3019031B1|2014-03-27|2014-03-27|DEVICE FOR ASSISTING THE PLACEMENT OF AN ORTHOPEDIC INSTRUMENT|FR1452677A| FR3019031B1|2014-03-27|2014-03-27|DEVICE FOR ASSISTING THE PLACEMENT OF AN ORTHOPEDIC INSTRUMENT|
    EP15160422.0A| EP2923677B1|2014-03-27|2015-03-23|Device for assisting with the placement of an orthopaedic instrument|
    [返回顶部]