Patent ID: 12201533

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described herein in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives consistent with the present disclosure and the appended claims.

Terms representing anatomical references, such as anterior, posterior, medial, lateral, superior, inferior, etcetera, may be used throughout the specification in reference to the orthopaedic implants or prostheses and surgical instruments described herein as well as in reference to the patient's natural anatomy. Such terms have well-understood meanings in both the study of anatomy and the field of orthopaedics. Use of such anatomical reference terms in the written description and claims is intended to be consistent with their well-understood meanings unless noted otherwise.

References in the specification to “one embodiment,” “an embodiment,” “an illustrative embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may or may not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. Additionally, it should be appreciated that items included in a list in the form of “at least one A, B, and C” can mean (A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C). Similarly, items listed in the form of “at least one of A, B, or C” can mean (A); (B); (C); (A and B); (A and C); (B and C); or (A, B, and C).

The disclosed embodiments may be implemented, in some cases, in hardware, firmware, software, or any combination thereof. The disclosed embodiments may also be implemented as instructions carried by or stored on a transitory or non-transitory machine-readable (e.g., computer-readable) storage medium, which may be read and executed by one or more processors. A machine-readable storage medium may be embodied as any storage device, mechanism, or other physical structure for storing or transmitting information in a form readable by a machine (e.g., a volatile or non-volatile memory, a media disc, or other media device).

In the drawings, some structural or method features may be shown in specific arrangements and/or orderings. However, it should be appreciated that such specific arrangements and/or orderings may not be required. Rather, in some embodiments, such features may be arranged in a different manner and/or order than shown in the illustrative figures. Additionally, the inclusion of a structural or method feature in a particular figure is not meant to imply that such feature is required in all embodiments and, in some embodiments, may not be included or may be combined with other features.

Referring now toFIG.1, a “smart” orthopaedic mallet100is configured to produce sensor data indicative of an impaction between the orthopaedic mallet100and a surgical tool102and determine whether an orthopaedic implant104is properly or sufficiently seated in a bone106of a patient based on the received impaction sensor data. For example, during some associated orthopaedic procedures such as the hip arthroplasty surgical procedure illustrated shown inFIG.1, an orthopaedic surgeon may be required to impact the orthopaedic implant104(e.g., a cementless acetabular cup shell) into the boney anatomy of the patient (e.g., the patient's acetabulum). To do so, the orthopaedic surgeon impacts or otherwise strikes the surgical tool102, which may be embodied as an implant inserter or impactor, with the orthopaedic mallet100. Typically, the implantation of the orthopedic implant into a patient's bone will require a series of strikes or impactions between the orthopaedic mallet100and the surgical tool102.

It has been noted, however, that each individual impaction between the orthopaedic mallet100and the surgical tool102includes an initial or primary impact and a secondary impact (and, in many cases, further impacts), which occurs subsequently to the initial impact. The secondary impact is generally not intended by the orthopaedic surgeon, but occurs do to the physics of the impaction between the orthopaedic mallet100and the surgical tool102.

For example, as shown inFIG.2, a graph200illustrates multiple impacts between the orthopaedic mallet100and the surgical tool102that occur during a single impaction event (i.e., as a result of a single strike of the orthopaedic mallet100onto the surgical tool102). As shown, the impaction includes an initial or primary impact202, which has a large force magnitude as indicated by the ordinate axis of the graph200. Additionally, the impaction includes a secondary impact204, which has a moderate force magnitude less than the initial impact202, but still noticeably distinct. It should be appreciated that the impaction of the orthopaedic mallet100and the surgical tool102illustrated inFIG.2is the result of an intended single strike (i.e., an impaction event) by the orthopaedic surgeon on the surgical tool102using the orthopaedic mallet100, even though the single strike or impaction event actually includes multiple, distinct impacts or contact events between the orthopaedic mallet100and the surgical tool102. That is, the secondary impact (and other resulting impacts) between by the orthopaedic mallet100and the surgical tool102may not be intended by the orthopedic surgeon, but occur nonetheless.

As shown inFIG.2, the secondary impact204occurs sometime after the initial impact202. That is, the secondary impact204is temporally separated from the initial impact202by a temporal length210. It should be appreciated that the temporal length210changes as the orthopaedic implant104becomes seated into the patient's boney anatomy. In particular, the temporal length210between the initial impact202and the secondary impact204generally decreases as the associated orthopaedic implant104is implanted into the patient's bone106.

Furthermore, in addition to the temporal length210decreasing as the orthopaedic implant104becomes seated into the patient's bone, the difference between temporal lengths210(i.e., the temporal distance between the initial impact202and the secondary impact204of a single strike or impaction event) of sequential strikes or impaction events decreases as the orthopaedic implant104becomes seated. For example, as shown inFIG.3, a graph300illustrates the difference in temporal lengths210of sequential impactions of the orthopaedic mallet100and the surgical tool102decreasing over time during implantation of an acetabular prosthetic cup trial. Similarly, as shown inFIG.4, a graph400illustrates the difference in temporal lengths210of sequential impactions of the orthopaedic mallet100and the surgical tool102decreasing over time during implantation of an acetabular prosthetic cup. That is, the rate of change between temporal lengths210of sequential impaction events decreases over time, as the number of impaction events increases and the orthopaedic implant104becomes seated into the patient's bone106. For example, the difference in temporal lengths between the first impaction/strike and the second impaction/strike is much greater than the difference in temporal lengths between the fourth impaction/strike and the fifth impaction/strike.

As such, the orthopaedic mallet100is configured to determine whether the orthopaedic implant104is sufficiently or properly seated into the patient's bone106by analyzing the temporal length210between the initial impact202and the secondary impact204of an impaction event or by analyzing the difference in temporal lengths of sequential impaction events. To do so, as shown inFIG.5, the illustrative orthopaedic mallet100includes one or more impaction sensors500and an impaction analyzer502configured to analyze impaction sensor data produced by the impaction sensor(s)500. The orthopaedic mallet100also includes a user interface504to provide notifications to the orthopaedic surgeon or other user regarding the seating of the orthopaedic implant104during the performance of the associated orthopaedic surgical procedure.

In use, as discussed in more detail below, the impaction analyzer502analyzes the sensor data produced by the impaction sensor(s)500to detect the initial impact202and the secondary impact204for each impaction of the orthopaedic mallet100. Additionally, the impaction analyzer502determines the temporal length210between the initial impact202and the secondary impact204for the associated impaction event and determines whether the orthopaedic implant104is sufficiently seated into the patient's bone based on the determined temporal length210. For example in some embodiments, the impaction analyzer502may determine that the orthopaedic implant104is properly or sufficiently seated into the patient's bone106in response to a determination that the temporal length210is below a reference threshold value. In some embodiments, for example, the impaction analyzer502may determine that orthopaedic implant104is sufficiently seated when the temporal length210is 1 milliseconds or less. In other embodiments, the impaction analyzer502may determine that the orthopaedic implant104is properly or sufficiently seated into the patient's bone106in response to a determination that a difference between the temporal length210of an individual strike or impaction event of the mallet100and the temporal length210of an immediately prior individual strike or impaction event of the mallet100is less than a reference threshold value (i.e., that the rate of change of temporal lengths210of subsequent impactions is less than a reference threshold). For example, in particular embodiments, the impaction analyzer502may determine that orthopaedic implant104is sufficiently seated when the difference between sequential temporal lengths210is 0.2 milliseconds or less. Of course, other threshold reference values may be used in other embodiments depending on particular criteria, such as the orthopaedic implant being used, the particular orthopaedic surgical procedure being implemented, and/or the particular impactor/inserter being used.

The impactions sensor(s)500may be embodied as any type of sensor capable generating or producing sensor data indicative of a strike or impaction event between the orthopaedic mallet100and the surgical tool102. In the illustrative embodiment, the impaction sensor500is embodied as a force sensor configured to generate force sensor data indicative of an impaction between the orthopaedic mallet100and the surgical tool102. However, in other embodiments, the impaction sensor500may be embodied as a strain gauge, accelerometer, piezoelectric sensor, an audio sensor (e.g., a microphone), or other sensor capable of producing sensor data from which the impaction of the orthopaedic mallet100and the surgical tool102can be determined. Although only one impaction sensor500is shown inFIG.5, it should be appreciated that the orthopaedic mallet100may include additional impaction sensors500in other embodiments. In such embodiments, the multiple impaction sensors500may be similar or of different types.

The impaction analyzer502may be embodied as any type of device or collection of devices capable of performing various compute functions and the functions described herein. In some embodiments, the impaction analyzer502may be embodied as a single device such as an integrated circuit, an embedded system, a field-programmable-array (FPGA), a system-on-a-chip (SOC), or other integrated system or device. In the illustrative embodiment, the impaction analyzer502includes a processor510, a memory512, and an input/output (IO) subsystem514. The processor510may be embodied as any type of processor capable of performing the functions described herein. For example, the processor510may be embodied as a single or multi-core processor(s), a digital signal processor, a microcontroller, discrete compute circuitry, other processor or processing/controlling circuitry. Similarly, the memory512may be embodied as any type of volatile and/or non-volatile memory or data storage capable of storing data, such as the sensor data produced by the impaction sensor500.

The impaction analyzer502is communicatively coupled to other components of the orthopaedic mallet100via the I/O subsystem514, which may be embodied as circuitry and/or components to facilitate input/output operations with impaction analyzer502(e.g., with the processor510and/or memory512) and other components of the orthopaedic mallet100. For example, the I/O subsystem514may be embodied as, or otherwise include, memory controller hubs, input/output control hubs, firmware devices, communication links (i.e., point-to-point links, bus links, wires, cables, light guides, printed circuit board traces, etc.) and/or other components and subsystems to facilitate the input/output operations.

The user interface504may be embodied as a collection of various output and/or input devices to facilitate communication between the orthopaedic mallet100and a user. Illustratively, the user interface504includes one or more output devices520and/or one or more input devices522. Each of the output devices520may be embodied as any type of output device capable of providing a notification or other information to the orthopaedic surgeon or other user. For example, the output devices520may be embodied as visual, audible, or tactile output devices. In the illustrative embodiment, the user interface504includes one or more visual output devices, such as a light emitting diode (LED), a light, a display screen, or the like. Each of the input devices522may be embodied as any type of input device capable of control or activation by the orthopedic surgeon to provide an input, data, or instruction to the impaction analyzer502. For example, the input devices522may be embodied as a button (e.g., an on/off button), a switch, a touchscreen display, or the like.

Referring now toFIG.6, an illustrative embodiment of the orthopaedic mallet100is shown. The illustrative mallet100includes a handle602and a mallet head604connected to the handle602via a shaft606. As with a typical hammer or mallet, the orthopaedic surgeon may grasp the mallet100by the handle602and swing the mallet100to cause impaction of the mallet head604with the surgical tool102(or other structure). The illustrative orthopaedic mallet100also includes an enclosure610coupled to the mallet head604, which houses the impaction analyzer502. The impaction sensor(s) may also be housed in the enclosure610or be located elsewhere in the mallet head604.

The mallet head604also includes the user interface504located on a backside612of the mallet head604. The illustrative user interface504includes a set of LEDs620. In user, as discussed in more detail below, the impaction analyzer502may be configured to activate or illuminate one of the LEDs620depending on how well the orthopaedic implant104is seated into the patient's bone106. For example, the impaction analyzer502may illuminate a yellow LED (or other color) when the temporal length210of an impaction is above a first referenced threshold indicative that the orthopaedic implant104is not sufficiently seated, a green LED (or other color) when the temporal length210of an impaction is below the first reference threshold but above a second reference threshold indicative that the orthopaedic implant104is sufficiently seated (but not overly impacted), and a red LED (or other color) when the temporal length210of an impaction is below the second reference threshold indicative that the orthopaedic implant104is overly impacted and additional impacting may result in the fracturing of the patient's bone.

Referring now toFIG.7, in some embodiments, the orthopaedic mallet100may be embodied as an automated impactor700, rather than a manual mallet. For example, the automated impactor700may be embodied as a Kincise™ surgical automated system component commercially available from DePuy Synthes of Warsaw, Indiana In the illustrative embodiment, the automated impactor700includes a impactor body702and a battery pack704, which provide power to electrical components located with the impactor body702configured to generate an impaction force. In such embodiments, the impaction sensor(s)500, the impaction analyzer502, and the user interface504may be located in or on the impactor body702.

Referring now toFIGS.8-10, in some embodiments, the impaction sensors500, the impaction analyzer502, and/or the user interface504may be distributed across different devices. For example, as shown inFIG.8, the impaction sensor(s)500may be located on the orthopaedic mallet100, while the impaction analyzer502is included in an external compute device800. In such embodiments, the orthopaedic mallet100may also include the user interface504, or the user interface504may be included in the external compute device800(or in both the orthopaedic mallet100and the external compute device800).

In use, the orthopaedic mallet100is configured to transmit the sensor data produced or generated by the impaction sensor(s)500to the external compute device800for analysis by the impaction analyzer502. To do so, the orthopaedic mallet100illustratively includes a communication circuit802configured to communicate with a corresponding communication circuit804of the external compute device800. The communication circuits802,804may be embodied as any type of communication circuits or devices capable of facilitating communications between the orthopaedic mallet100and the external compute device800. To do so, the communication circuits802,804may be configured to use any one or more communication technologies (e.g., wireless or wired communications) and associated protocols (e.g., Ethernet, Bluetooth®, Wi-Fi®, WiMAX, LTE, 5G, etc.) to effect such communication.

The external compute device800may be embodied as any type of compute device capable of performing the functions of the impaction analyzer502, such as a desktop computer, a special-built compute device, a mobile compute device, a laptop computer, a tablet computer, or other computer or compute device. In addition to the impaction analyzer502, the communication circuit804, and, optionally, the user interface504, the external compute device800may include other components commonly found in a compute device, such as a data storage device and various input devices (e.g., a keyboard, mouse, etc.)

As discussed above, the external compute device800is configured to receive the impaction sensor data from the orthopaedic mallet100, and the impaction analyzer502of the external compute device800is configured to analyze the received sensor data to determine whether the orthopaedic implant104is sufficiently seated as discussed above. In embodiments in which the external compute device800includes the user interface504, the impaction analyzer502may be further configured to control the user interface504(e.g., a display) to generate an alert or notification to the orthopaedic surgeon related to the seating of the orthopaedic implant104as discussed above. In those embodiments in which the external compute device800does not include the user interface504, the external compute device800may be configured to transmit the alert or notification back to the orthopaedic mallet100for display or output to the orthopaedic surgeon on the user interface504of the orthopaedic mallet100.

In other embodiments, as shown inFIG.9, the impaction sensor(s)500may be located on the surgical tool102, and the impaction analyzer502and the user interface504may be located on the orthopaedic mallet100. In such embodiments, the surgical tool102also includes a communication circuit906, which may be substantially similar to the communication circuits802,804described above. In use, the surgical tool102is configured to transmit the impaction sensor data sensed, generated, or otherwise produced by the impaction sensor(s)500to the orthopaedic mallet100for analysis by the impaction analyzer502as described above.

Alternatively, the impaction analyzer502and the user interface504may be located in the external compute device800, rather than the orthopaedic mallet100. In such embodiments, the surgical tool102is configured to transmit the impaction sensor data to the external compute device800for analysis by the impaction analyzer502as described above. The external compute device800may subsequently provide any alert or notification generated by the impaction analyzer502to the orthopaedic surgeon via the user interface504located on the external compute device800(or on orthopaedic mallet100, depending on the particular embodiment).

In some embodiments, as shown inFIG.10, the impaction sensor(s)500may be embodied as external impaction sensor(s), which are not located on either the orthopaedic mallet100or the surgical tool102. Furthermore, in such embodiments, the impaction analyzer502and the user interface504may be located on the external compute device800. As such, the orthopaedic mallet100and the surgical tool102may be embodied as typical orthopaedic tools (i.e., not “smart” surgical tools) and include no electrical components.

In such embodiments, the external impaction sensor(s)500may be embodied any type of sensor capable of producing sensor data indicative of impaction between the orthopaedic mallet100and the surgical tool102, even though the sensors500are not in physical contact with either the orthopaedic mallet100or the surgical tool102. For example, in an embodiment, the external impaction sensor(s)500are embodied as audio sensors (e.g., microphones) capable of generating audio sensor data indicative of impaction between the orthopaedic mallet100and the surgical tool102. In such embodiments, the audio sensor data may resemble the sensor data illustrated inFIGS.2-4and, as such, the impaction analyzer502may determine whether the orthopaedic implant104is sufficiently seated by analyzing the audio sensor data as described above. For example, the impaction analyzer502may analyze the audio sensor data to identify the initial and secondary impacts, determine the temporal length between the initial and secondary impacts, and determine whether the orthopaedic implant104is sufficiently seated based on the temporal length (or on a difference between temporal lengths of sequential impactions).

Referring now toFIGS.11-14, in use, the impaction analyzer502may perform a method1100for determining whether an orthopaedic implant is sufficiently seated. The method1100begins with block1102in which the impaction analyzer502determines whether to assist the orthopaedic surgeon in the performance of an orthopaedic surgical procedure. For example, in block1102, the impaction analyzer502may determine whether the orthopaedic mallet100(or external compute device800) has been switched on and/or whether a proper input button or other device (e.g., a “start” button) has been selected by the orthopaedic surgeon. If so, the method1100advances to block1104in which the impaction analyzer502receives the sensor data from the impaction sensor(s)500.

Subsequently, in block1106, the impaction analyzer502analyzes the sensor data to detect or identify the initial impact202of an impaction. To do so, in block1108, the impaction analyzer502may determine whether a magnitude of the sensor data (e.g., a magnitude of force) is greater than a reference threshold. That is, the impaction analyzer502may determine that an initial impact of the orthopaedic mallet100and the surgical tool102(or other structure) has occurred in response to a determination that a peak of the sensor data is greater than a reference threshold force or other measurement. In block1110, if the impaction analyzer502determines that no initial impact has been detected, the method1100loops back to block1104in which the impaction analyzer502receives addition sensor data from the impaction sensor500. In this way, the impaction analyzer502is configured to sample the sensor data. It should be appreciated that the sampling rate of the impaction analyzer502must be sufficiently high enough to detect the initial and secondary impacts. Illustratively, the impaction analyzer502may utilize a sampling rate of 100 kilohertz (kHz), but other sampling rates may be used in other embodiments.

If, however, the impaction analyzer502detects the initial impact of the impaction between the orthopaedic mallet100and the surgical tool102, the method1100advances to block1112ofFIG.12. In block1112, the impaction analyzer502analyzes the sensor data to detect or identify the secondary impact204of an impaction. To do so, in block1114, the impaction analyzer502may determine whether a magnitude of the sensor data is greater than a reference threshold, which may be different (e.g., lower) than the reference threshold used to detect the initial impact.

After the impaction analyzer502has detected the initial and secondary impacts202,204, the impaction analyzer502determines or calculates the temporal length210between the initial impact202and the secondary impact204in block1116. Subsequently, in block1118ofFIG.13, the impaction analyzer502determines whether the orthopaedic implant104is sufficiently seated in the patient's bone106based on the determined temporal length. To do so, in some embodiment as discussed above, the impaction analyzer502may determine whether the calculated temporal length is less than a reference threshold in block1120. Alternatively, in block1122, the impaction analyzer502may determine whether a rate of change of the temporal lengths of sequential impactions between the orthopaedic mallet100and the surgical tool102is less than a reference threshold. For example, as shown in block1124, the impaction analyzer502may determine whether a difference between the temporal length of the most recent impaction and temporal length of the immediately prior impactions is less than a reference threshold as discussed above in regard toFIGS.3and4.

In some embodiments, in block1126ofFIG.14, the impaction analyzer502is configured to activate one or more output devices based on the determined temporal length. To do so, in block1128, the impaction analyzer502may select the output device to be activated. For example, in some embodiments as discussed above, the impaction analyzer502may be configured to active different output devices (e.g., different LEDs) based on whether the determined temporal length (or difference of temporal lengths) is greater than a first referenced threshold indicative that the orthopaedic implant104is not sufficiently seated, less than the first reference threshold but greater than a second reference threshold indicative that the orthopaedic implant104is sufficiently seated (but not overly impacted), or is less than the second reference threshold indicative that the orthopaedic implant104is overly impacted and additional impacting may result in the fracturing of the patient's bone.

Regardless, in block1130, the impaction analyzer502determines whether the orthopaedic implant104is sufficiently seated based on the determined temporal length(s) as discussed above. If not, the method1100loops back to block1104in which the impaction analyzer502receives and analyzes further sensor data. If, however, the impaction analyzer502determines that the orthopaedic implant104is properly seated based on the determined temporal length(s), as discussed above, the method advances to block1132in which the impaction analyzer502actives the appropriate output device520to notify the orthopaedic surgeon or other user that the orthopaedic implant104is sufficiently seated (e.g., by illuminating an LED or displaying a message on a display screen).

While certain illustrative embodiments have been described in detail in the drawings and the foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected.

There are a plurality of advantages of the present disclosure arising from the various features of the method, apparatus, and system described herein. It will be noted that alternative embodiments of the method, apparatus, and system of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the method, apparatus, and system that incorporate one or more of the features of the present invention and fall within the spirit and scope of the present disclosure as defined by the appended claims.