阅读说明：本技术 用于术中、术后跟踪外部固定部件或环之间的相对位置的装置、软件、系统和方法 (Devices, software, systems and methods for intraoperative, postoperative tracking of relative position between external fixation components or rings ) 是由 安德鲁·P·诺布利特 约翰尼·梅森 查尔斯·霍蒂斯 于 2019-04-02 设计创作，主要内容包括：本公开提供了一种术中外部固定部件跟踪系统,以使得外科医生能够有效地规划外部固定器的构造。术中外部固定部件跟踪系统还使得能够在术中捕获与手术有关的数据,包括用于确定外部固定器的支柱调整计划的数据以便在术后使用。本公开还提供了一种术后外部固定部件跟踪系统,以使得患者能够有效地调整安装的外部固定器的支柱。术后外部固定部件跟踪系统还使得外科医生能够远程监测患者对支柱调整计划的依从性。(The present disclosure provides an intraoperative external fixation component tracking system to enable a surgeon to effectively plan the configuration of an external fixator. The intraoperative external fixation component tracking system also enables intraoperative capture of data relating to the procedure, including data for determining a strut adjustment plan for the external fixator for use post-operatively. The present disclosure also provides a post-operative external fixation component tracking system to enable a patient to effectively adjust the struts of a mounted external fixator. The post-operative external fixation component tracking system also enables the surgeon to remotely monitor patient compliance with the strut adjustment plan.)

1. An electronic device, comprising:

a storage device;

a display; and

a controller coupled to the storage device and the display, the controller to:

receiving one or more inputs for determining a strut adjustment plan for a patient during a surgical procedure in which an external fixator is installed on the patient;

receiving additional data related to the surgical procedure during the surgical procedure;

storing the one or more inputs and the additional data used to determine the strut adjustment plan in the storage device;

displaying the one or more inputs and the additional data for determining the strut adjustment plan on the display; and

electronically transmitting the one or more inputs and the additional data for determining the strut adjustment plan to a remote device after completion of the surgical procedure.

2. The electronic device of claim 1, wherein the one or more inputs and the additional data for determining the strut adjustment plan are stored organized by patient identification associated with a patient.

3. The electronic device of claim 1, wherein the one or more inputs and the additional data for determining the strut adjustment plan are stored organized by a procedure identification associated with the surgical procedure.

4. The electronic device of claim 1, wherein the one or more inputs and the additional data for determining the strut adjustment plan are automatically transmitted.

5. The electronic device of claim 1, wherein the one or more inputs and the additional data for determining the strut adjustment plan are transmitted upon user consent.

6. The electronic device of claim 1, wherein the one or more inputs for determining the strut adjustment plan include a size of each external fixation component of the external fixator.

7. The electronic device of claim 6, wherein the one or more inputs for determining the strut adjustment plan include a type of each external fixation component of the external fixator.

8. The electronic device of claim 7, wherein the one or more inputs for determining the strut adjustment plan include a mounting position of at least one external fixation component of the external fixator.

9. The electronic device of claim 6, wherein the one or more inputs for determining the strut adjustment plan include a type of strut attached to each external fixation component of the external fixator.

10. The electronic device of claim 9, wherein the one or more inputs for determining the strut adjustment plan include a length of the strut.

11. The electronic device of claim 10, wherein the length of the strut is received by a user manipulating a user interface of the electronic device.

12. The electronic device of claim 10, wherein the length of the strut is automatically received from a tracking system attached to the external fixator.

13. The electronic device of claim 12, wherein the length of the strut is wirelessly received from the tracking system attached to the external fixator.

14. The electronic device of claim 1, wherein the additional data related to the surgical procedure includes at least one of textual data and visual data.

15. A tracking system, comprising:

a first tracking component configured to be coupled to a first external fixation component of an external fixator; and

a second tracking component configured to be coupled to a second external fixation component of the external fixator, wherein the first tracking component includes a controller that determines position data indicative of a relative position between the first and second external fixation components in real-time based on data from the first tracking component, the controller wirelessly transmitting the determined position data to a remote device.

16. The tracking system of claim 15, the first tracking component comprising an optical sensor.

17. The tracking system of claim 16, the optical sensor comprising an optical camera.

18. The tracking system of claim 17, the second tracking component comprising an LED target.

19. The tracking system of claim 15, the controller wirelessly transmitting the determined location data to the remote device during a surgical procedure in which the external fixator is installed on a patient.

20. The tracking system of claim 19, the determined position data being used to determine a position of the second external fixation component during the surgical procedure.

21. The tracking system of claim 19, the determined position data being used to determine a length and type of strut attached to the first and second external fixation components during the surgical procedure.

22. The tracking system of claim 15, the controller determining a length of struts attached to the first and second external fixation components based on the determined position data after completion of the surgical procedure.

23. The tracking system of claim 22, the controller wirelessly transmitting the determined length of the strut to the remote device after completion of the surgical procedure.

24. The tracking system of claim 23, the determined length of the strut is used to verify compliance with a strut adjustment plan associated with the external fixator.

Technical Field

The present disclosure relates generally to medical devices and more particularly, but not exclusively, to devices, systems and methods for intraoperative, postoperative tracking of relative position between external fixation components or rings and to devices, systems and methods for linking intraoperative surgical procedures and postoperative prescription software into a seamless integrated software system.

Background

Orthopedic or skeletal deformity correction devices or skeletal adjustment systems (used interchangeably herein and not intended to be limiting), such as hexapods, external fixators or fixation systems are known. One well-known orthotic device is the Taylor (Taylor) space frame. In use, the orthotic device may utilize first and second external fixation members, frames or rings (used interchangeably herein and not intended to be limiting) and a plurality of adjustable bodies (e.g., typically four or six interconnected bodies or struts). The adjustable body or strut (used interchangeably herein and not intended to be limiting) may take the form of a telescopic rod, such that in use the strut may be shortened or lengthened as required to construct an orthotic device intra-operatively or to adjust the relative position between the first and second fixation members post-operatively, and thus the bone attached thereto. As a result, each individual strut includes a minimum length and a maximum length. During surgery, the surgeon may mount the first fixation component to the patient. Next, the surgeon may install the second fixation component onto the patient. Finally, the surgeon may interconnect the two components using adjustable struts.

Despite the clinical success of such orthotic devices in orthopedic applications, a number of challenges remain. For example, in surgery, the surgeon must carefully plan the application and location of the first and second fixation components because the limited range of struts (e.g., the maximum length and/or minimum length of each strut) limits how close the first and second fixation components can be mounted to each other. If not properly planned, the surgeon may not be able to interconnect the first and second fixation components and the installation process may have to be repeated. Additionally and/or alternatively, the struts may need to be replaced with longer or shorter struts post-operatively during treatment.

Additionally, orthopedic deformity correction devices (e.g., Taylor space frames) may utilize software packages (typically network-based) to substantially align bone segments and help generate prescriptions. For purposes of illustration, as will be described in more detail below, the software used to generate the prescription will be referred to as "prescription software" throughout this document. The prescription may be or may specify a bracing adjustment plan for the installed orthotic. These prescription software packages, applications, components, or modules (used interchangeably herein and not intended to be limiting) require the surgeon to enter a number of parameters to fully treat the surgical case. Some prescription software inputs, such as deformity parameters, may be obtained post-operatively from medical imaging. However, other prescription software inputs must be collected from the orthotic device attached to the patient during surgery, such as the length of each strut.

In use, the orthotic device is typically designed such that the intraoperative surgical procedures of the attached hardware and prescription software are completely separated. Surgeons typically install hardware on the patient and then use software post-operatively. Some software applications allow/require some preoperative planning within the software, and then may make final adjustments in the software post-operatively. In either case, however, the separation of hardware and software means that the surgeon can easily forget to record all necessary inputs for the prescription software during installation. If the necessary software input is not collected during surgery and cannot be obtained from medical images, a follow-up of the patient may be required to obtain the missing information.

In addition, in addition to the required prescription software input, surgeons typically record multiple notes in a case. If the surgeon wishes to obtain notes on a case within the prescription software, these notes must be entered into the software post-operatively.

Post-operative, patient management is also still challenging. Generally, the patient is prescribed (e.g., prescribed a strut adjustment plan) that defines the particular strut adjustments to achieve the final desired bone position, and is responsible for complying with the prescription. Depending on the position and orientation of the orthotic device, visualization of the adjustment scales located on each of the struts and/or making the desired adjustments can be a difficult task for the patient to individually handle. That is, post-operatively, the struts must be extended or shortened according to the prescription during the adjustment phase of the treatment. Therefore, after surgery, the success of the orthotic device is largely dependent on the patient. To achieve good results, the patient must correctly follow the prescription for the strut adjustment. However, as stated above, depending on the manner and location of installing the stanchion, visualizing the stanchion length through physical scales on the frame may be difficult. Additionally, if the maximum or minimum length of the strut is reached, the strut must be removed and replaced with a strut of a different size if additional lengthening or shortening is required so that additional adjustment can be made.

Accordingly, it would be advantageous to provide an improved system that includes an apparatus and method for tracking the position of a stationary component pre-operatively and post-operatively, and that can link pre-operative surgical procedures and post-operative prescription software into a seamless integrated software system. The present disclosure has been made in view of these considerations.

Disclosure of Invention

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

The present disclosure provides an intraoperative external fixation component tracking system to enable a surgeon to effectively plan the configuration of an external fixator. The intraoperative external fixation component tracking system also enables intraoperative capture of data relating to the procedure, including data for determining a strut adjustment plan for the external fixator for use post-operatively. The present disclosure also provides a post-operative external fixation component tracking system to enable a patient to effectively adjust the struts of a mounted external fixator. The post-operative external fixation component tracking system also enables the surgeon to remotely monitor patient compliance with the strut adjustment plan.

In one embodiment, an electronic device is disclosed. The electronic device may include a storage device, a display, and a controller. The controller may be coupled to the storage device and the display. The controller may be configured to: receiving one or more inputs for determining a strut adjustment plan for a patient during a surgical procedure in which an external fixator is installed on the patient; receiving additional data related to the surgical procedure during the surgical procedure; storing the one or more inputs and the additional data used to determine the strut adjustment plan in the storage device organized by patient identification associated with a patient and by procedure identification associated with the surgical procedure; displaying the one or more inputs and the additional data for determining the strut adjustment plan on the display; and automatically transmitting the one or more inputs and the additional data for determining the strut adjustment plan to a remote device after completion of the surgical procedure.

In one embodiment, the one or more inputs for determining a strut adjustment plan may include a size of each external fixation component of the external fixator.

In one embodiment, the one or more inputs for determining a strut adjustment plan may include a type of each external fixation component of the external fixator.

In one embodiment, the one or more inputs for determining a strut adjustment plan may include a mounting position of each external fixation component of the external fixator.

In one embodiment, the one or more inputs for determining a strut adjustment plan may include a type of each strut attached to each external fixation component of the external fixator.

In one embodiment, the one or more inputs for determining the strut adjustment plan include a length of each strut.

In one embodiment, the length of each strut is received by a user manipulating a user interface of the electronic device.

In one embodiment, the length of each strut is automatically received from a tracking system attached to the external fixator.

In one embodiment, the length of each strut is wirelessly received from the tracking system attached to the external fixator.

In one embodiment, the additional data related to the surgical procedure includes at least one of textual data and visual data.

In one embodiment, a tracking system is disclosed. The tracking system may include: a first tracking system component configured to be coupled to a first external fixation component of an external fixator; and a second tracking system component configured to be coupled to a second external fixation component of the external fixator. The first tracking system component may include a controller. The controller may determine, in real time, position data indicative of a relative position between the first and second external fixation components based on data from the first tracking system component. The controller may wirelessly transmit the determined location data to a remote device.

In one embodiment, the first tracking system component may comprise an optical sensor.

In one embodiment, the optical sensor is an optical camera.

In one embodiment, the second tracking system component is an LED target.

In one embodiment, the controller wirelessly transmits the determined location data to the remote device during a surgical procedure in which the external fixator is installed on a patient.

In one embodiment, the determined position data is used to determine an installation position of the second external fixation component relative to a known installation position of the first external fixation component during the surgical procedure.

In one embodiment, the determined position data is used to determine a length and a type of each strut attached to the first and second external fixation components during the surgical procedure.

In one embodiment, after completion of the surgical procedure, the controller determines a length of each strut attached to the first and second external fixation components based on the determined position data.

In one embodiment, the controller wirelessly transmits the determined length of each strut to the remote device after completion of the surgical procedure.

In one embodiment, the determined length of each strut is used to verify compliance of a strut adjustment plan associated with the external fixator.

Embodiments of the present disclosure provide a number of advantages. For example, during surgery, an intraoperative external fixation component tracking system enables a surgeon to effectively plan the configuration of an external fixator, thereby ensuring minimal strut replacement. The intraoperative external fixation component tracking system also enables intraoperative capture of data relating to the procedure, including data for determining a strut adjustment plan for the external fixator for use post-operatively. In addition, the post-operative external fixation component tracking system enables the patient to effectively adjust the struts of the installed external fixator. The post-operative external fixation component tracking system also enables the surgeon to remotely monitor patient compliance with the strut adjustment plan and provide a feedback loop between the surgeon and the patient to ensure proper patient care.

Further features and advantages of at least some of the embodiments of the invention, as well as the structure and operation of the various embodiments of the invention, are described in detail below with reference to the accompanying drawings.

Drawings

Specific embodiments of the apparatus of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 illustrates an embodiment of an intraoperative external fixation component tracking system according to the present disclosure;

FIG. 2 shows an embodiment of the external fixator and tracking system depicted in FIG. 1;

FIG. 3 illustrates an embodiment of a post-operative external fixation component tracking system according to the present disclosure;

FIG. 4 shows an embodiment of a user interface provided by the patient computing device depicted in FIG. 3;

FIG. 5 shows a block diagram of an embodiment of a computing device according to the present disclosure; and

fig. 6 shows a block diagram of an embodiment of the tracking system depicted in fig. 1 and 3.

The figures are not necessarily to scale. The drawings are merely representational and are not intended to portray specific parameters of the disclosure. The drawings are intended to depict example embodiments of the disclosure, and therefore are not to be considered limiting of scope. In the drawings, like numbering represents like elements.

Detailed Description

For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to exemplary embodiments. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the disclosure as described herein are contemplated as would normally occur to one skilled in the art to which the disclosure relates.

The present disclosure relates to a system and method for monitoring and/or tracking the relative position of external fixation components (e.g., first and second external fixation frames or rings) during and after surgery. The relative position data may be transmitted from the tracking system to a software system (including one or more software applications). The position data can be used intra-operatively by the surgeon to help properly install the external fixation components (e.g., the first and second fixation frames or rings) onto the patient, thus eliminating the need for the surgeon to pre-construct the frames and/or to experiment with the installation location during the surgical procedure. After surgery, the software may monitor the relative position data measured by the tracking system to provide a patient-surgeon feedback loop. Additionally, the location data may also be available/visible to the patient to help achieve a prescription that specifies strut adjustments to be made over time.

Fig. 1 illustrates an embodiment of an intraoperative external fixed component tracking system 100. The external fixation component tracking system 100 may be used to track the relative position of the external fixation components of the external fixator during an installation procedure of the external fixator. As a result, the surgeon can install the external fixator more efficiently without the need to pre-construct the external fixator and/or to experiment with the installation location of the external fixation components. In addition, the surgeon can confidently install the external fixator with a strut adjustment plan (e.g., prescription) that enables the external fixator with minimal replacement of the initial strut. Further, the intraoperative external fixation component tracking system 100 enables acquisition of any information relating to the patient, the installed external fixator, or the installation procedure post-operatively for use post-operatively, including for generating a strut adjustment plan.

As shown in fig. 1, the intraoperative external fixation component tracking system 100 may include an external fixator 102, a tracking system 104, a local computing device 106, and a remote computing system 108. The external fixator 102 may be any bone alignment or correction device now known or hereafter developed. The external fixator 102 may include first and second fixation frames or rings connected by one or more struts. The tracking system 104 may be any tracking system now known or hereafter developed. The tracking system 104 may be coupled to the external fixator 102 and may track the relative positions of the first and second fixation frames or rings of the external fixator 102.

The local computing device 106 may be any suitable computing device now known or hereafter developed including, for example, a smartphone, tablet, laptop, notebook, netbook, Personal Computer (PC), etc. The remote computing system 108 may be any suitable remote computing system now known or hereafter developed including, for example, a remote computing device, a remote computer network, or a remote cloud network or platform.

The tracking system 104 may communicate with the local computing device 106 and/or the remote computing system 108 directly or indirectly through any known wireless communication standard or protocol. The local computing device 106 may also communicate with the remote computing system 108 directly or indirectly through any known wireless communication standard or protocol. Exemplary wireless connections and/or protocols may include, for example, Wi-Fi (e.g., any IEEE802.11a/b/g/n network), Bluetooth Low Energy (BLE), Near Field Communication (NFC), any cellular communication standard, any infrared communication protocol, and so forth.

In various embodiments, the relative positions of the first and second fixed frames or rings of the external fixator 102 may be detected by the tracking system 104 and reported to the local computing device 106. The local computing device 106 may be queried during installation of the external fixator 102 to plan and properly position the first and second fixation frames or rings of the external fixator 102. The local computing device 106 may transmit information regarding the installation of the external fixator 102 provided by the tracking system 104 to the remote computing system 108 for post-operative use as described herein.

Fig. 2 shows an embodiment of the external fixator 102 and tracking system 104 depicted in fig. 1. The external fixator 102 may include a first external fixation member 202 (e.g., a first fixation frame or ring) and a second external fixation member 204 (e.g., a second fixation frame or ring). The first external fixation component 202 and the second external fixation component 204 may be connected by one or more struts 206. Six struts 206 are shown connecting the first external fixation component 202 with the second external fixation component 204, but the external fixator 102 is not limited thereto. That is, any number of struts 206 may connect the first and second external fixation components 202, 204.

The tracking system 104 may include a first tracking system component 208 and a second tracking system component 210. The first tracking system component 208 may be connected to the first external fixation component 202 and the second tracking system component 210 may be connected to the second external fixation component 204.

In one embodiment, the first tracking system component 208 may be or may include an optical sensor, e.g., an optical camera, and the second tracking component 210 may be a target, e.g., an LED target. In an alternative embodiment, the first tracking system component 208 may be a non-optical sensor. In general, the first and second tracking- system components 208, 210 may be components of any sensor system now known or hereafter developed that may monitor and/or track the relative positions of the first and second tracking- system components 208, 210, and thus the first and second external fixation components 202, 204 (e.g., indirectly). In one embodiment, the first tracking system component 208 may be or may include a laser-based sensor or an infrared-based sensor.

In use, the first tracking-system component 208 (e.g., an optical camera) tracks the relative position of the second tracking-system component 210 (e.g., a target) in space to provide relative position data (e.g., corresponding to six struts 206) in real-time in all six degrees of freedom. It should be understood that although the present disclosure will be described and illustrated in terms of a fixed frame or ring, it is contemplated that the tracking system 104 may be used in conjunction with other external fixation components (e.g., a linear bone shift frame). The first tracking system component 208 may determine the distance between the first outer fixed component 202 and the second outer fixed component 204 in real time. The distance may be position data of the first and second external fixation components 202, 204 and may be based on any data, signals, or information provided by the sensors of the first tracking system component 208. The first tracking system component 208 may also determine the length of each strut 206. The length of each strut 206 may be based on the determined distance between the first and second outer securing components 202, 204.

The tracking system 104 may include a transceiver to facilitate wireless communication with the local computing device 102 and/or the remote computing system 108. Alternatively, the tracking system 104 may be operatively coupled to any external computing device (e.g., the local computing device 102) by a hardwired connection.

In various embodiments, the tracking system 104 may be a small, lightweight, accurate, and inexpensive optical tracking system. By mounting the tracking system 104 to the external fixator 102, relative position data of the first external fixation element 202 and the second external fixation element 204 may be tracked and monitored. In addition, the relative position data of the first and second external fixation components 202, 204 may be used to determine the length of each strut 206. The relative position data of the first and second external fixation components 202, 204 and the length data of each strut 206 may be provided to a user (e.g., a surgeon) via the local computing device 106 (e.g., provided on a display of the local computing device 106). The relative position data of the first external fixation component 202 and the second external fixation component 204 and the length data of each strut 206 may be provided to the local computing device 106 in real-time and automatically. In turn, the displayed relative position data of the first and second external fixation components 202, 204 and any length data of each stent 206 displayed may be dynamically updated on the local computing device 106 as the first and second external fixation components 202, 204 are moved relative to each other or if any struts 206 are adjusted.

During surgery, the surgeon may initially install the first external fixation component 202 onto the patient with the first tracking system component 208 installed on the patient. Next, the surgeon may position the second external fixation component 204 on the patient with the second tracking system component 210 installed on the patient. Using software associated with the intraoperative external fixation component tracking system 100, the surgeon can properly position the second external fixation component 204 relative to the installed first external fixation component 202 prior to fully installing the second external fixation component 204 to the patient. In general, the first external fixation component 202 and the second external fixation component 204 may be mounted to the patient in any order.

In various embodiments, the tracking system 104 and associated software may enable the surgeon to select component parameters (e.g., fixation component type, fixation component size, etc.) and candidate initial positions of the first and second external fixation components 202, 204 that ensure that the first and second external fixation components 202, 204 may be connected by the available struts 206. Further, the tracking system 104 and associated software may estimate the patient's strut adjustment plan based on the candidate initial positions of the first and second external fixation components 202, 204 and other necessary software inputs. Based on the candidate initial positions and the estimated strut adjustment plan, the tracking system 104 and associated software may predict the likelihood that any of the struts 206 may need to be replaced (e.g., replacing a shorter or longer strut over the length of time that the patient is wearing the external fixator 102 according to the estimated strut adjustment plan). This allows the surgeon to intelligently select the initial mounting locations of the first and second external fixation components 202, 204 and the initial strut 206 in a manner that ensures configurability with minimal replacement of any strut 206.

As previously mentioned, the external fixed component tracking system 100 may, or may be associated with, a software system that includes one or more software applications. The software applications may be provided by the local computing device 106, the remote computing system 108, or the tracking system 104, individually or collectively. The software application may be provided by a remote server and may be network-based or may reside on the local computing device 106, the remote computing system 108, and/or the tracking system 104. In one embodiment, the software system may include an intraoperative software application, a prescription software application (or an orthotic analysis application), and a patient software application, each of which is further described herein.

In an embodiment, the intraoperative software application may be provided by the local computing device 106 (e.g., through a web-based server). A sales representative or surgical personnel may use an intraoperative software application to collect and organize data related to a surgical procedure in real-time during the surgical procedure. For example, the interactive software application may allow notes, photographs, videos, and other surgical parameters to be collected and organized during a surgical procedure. The collected data may then be provided to a remote computer system 108 for storage and further use as described herein.

In one embodiment, intraoperative software may be associated with the tracking system 104 installed on the external fixator 102 and may be used intraoperatively to assist in the procedure of installing the external fixator 102 on the patient as described herein. That is, for example, the tracking system 104 and intraoperative software may be used intraoperatively to display data (e.g., position data of the first and second external fixation components 202, 204 and/or length data of any struts 206) in real time on the local computing device 106. Thus, the intraoperative software may enable a surgeon to effectively plan initial installation positions of the first and second external fixation components 202, 204 as described herein.

For example, in the intraoperative, relative position data between the first tracking system component 208 and the second tracking system component 210 may be transmitted to intraoperative software residing on the local computing device 106. Using intraoperative software, the surgeon can adjust the relative positions of the first and second external fixation components 202, 204 until the surgeon is satisfied that the length of the strut 206 is within the physical constraints of the external fixator 102, ensuring that the external fixator 102 is configurable. Since the length of the strut 206 may be visualized by the intraoperative software, the surgeon may also manipulate the position of the first and second external fixation components 202, 204 to avoid replacing the strut 206 early in the prescription (e.g., replacing an existing strut with a longer or shorter strut). In some cases where the preoperative plan includes the patient's deformity parameters and reference ring position, the tracking system 104 may communicate with intraoperative software to actively resolve the final strut adjustment length during application of the external fixator 102.

That is, in one embodiment, the relative positions of the first and second tracking system components 208, 210 may be used to define the length of the hardware component (e.g., the strut 206) connecting the first and second external fixation components 202, 204. As the first and second external fixation components 202, 204 are manipulated into position, the surgeon may view the length of the struts 206 required to construct the external fixator 102. Thus, the surgeon may avoid building the external fixation device 102 outside the physical constraints of the strut 206 and may optimize its position prior to attaching the first and second external fixation components 202, 204 to the patient.

In addition, the intraoperative software that provides the active final solution may assist the surgeon in positioning the first external fixation component 202 and the second external fixation component 204 with guidelines that may optimize or eliminate replacement of the strut 206 throughout the prescription process. Thus, the intraoperative external fixation component tracking system 100 can improve surgeon confidence during application of the external fixator 102 and can minimize the amount of time it takes to replace the strut 206 in a clinic.

Additionally, in use, the surgeon may use intraoperative software for preoperative planning of the deformity and identify preferred mounting locations for the first and second external fixation components 202, 204. For example, in one embodiment, using intraoperative software, the surgeon may select a preoperative plan or calculate a preoperative prescription to correct the deformity during application of the external fixator 102, if desired. Thereafter, the desired prescription for the length of the strut 206 may be adjusted in real time as the surgeon manipulates the position of the first and second external fixation components 202, 204 intraoperatively. This method allows the surgeon to minimize or possibly eliminate replacement of the strut 206 throughout the post-operative prescription.

In an embodiment, the intraoperative software provided by the local computing device 106 may provide the preoperative and postoperative planning described herein to the surgeon based on the monitoring and/or tracking data provided by the tracking system 104.

Once the position of the first and second external fixation components 202, 204 is fixed, the length of the struts 206 of the external fixator 102 configured may be transmitted or made accessible to the surgeon through software or a web portal facing the surgeon, thereby eliminating the need to manually enter this value into the prescription generation software. Thus, using the tracking system 104 and associated software according to the present disclosure enables more accurate input of the prescription software application. Additionally, at the end of the surgical procedure, the surgeon may complete any remaining steps required to create or finalize the patient's strut adjustment prescription.

In addition, the intraoperative software may allow the surgeon to record additional organized case parameters, notes, and photographs during the procedure. That is, intraoperative, in one embodiment, intraoperative software allows the surgeon to record case parameters during surgery on the local computing device 106. For example, the intra-operative software may allow for recording of any data related to the patient, procedure, or configuration of the external fixator 102, including, for example, the size and/or type of the first and second external fixator members 202, 204, the length of the struts 206, the type of struts 206, the mounting location of the struts 206 and/or the first and second external fixator members 202, 204, and any other parameters that may be used to generate a patient's strut adjustment prescription, etc.

In addition, the intraoperative software can also facilitate storage of photographs, notes, etc. taken during surgery, which can also be organized by case and/or patient. For example, the picture may provide valuable information about the patient's soft tissue as well as valuable information to construct the permanent fixture 102 that may not be readily discernable from the medical image. Generally, any data or information that may be used to generate a post adjustment plan post-operatively may be captured intra-operatively using intra-operative software, and any other data that may be relevant to the procedure of installing the external fixator 102, where at least some of the data or information is provided to the intra-operative software from the tracking system 104 in real-time and/or automatically. Further, the intraoperative software can automatically provide any captured data to the prescription software such that the input for determining the strut adjustment plan is pre-populated based on the provided data.

In various embodiments, the intraoperative software may be interactive software that automatically loads and/or displays captured input that a user can view and manipulate. In various embodiments, the intraoperative software can present the captured input in one or more pre-populated fields, and can provide an interactive PDF file or form. The intraoperative software can provide a visual rendering (e.g., CAD rendering) of the external fixator 102 as it is being constructed.

The prescription software application may be provided by the local computing device 106 or the remote computing system 108. In an embodiment, the prescription software application (or corrective analysis software) is provided by the remote computing system 208. The prescription software application may generate the strut adjustment plan based on an intraoperative software application provided by the local computing device 106 or by direct input of provided information. In an embodiment, after completion of the procedure, data may be uploaded from the intraoperative software to prescription software (e.g., manually or automatically) that may be used by the surgeon to generate a prescription for the patient. The data uploaded to the prescription software application can be organized by case and/or patient. For example, the remote computing system 108 may include a database for storing case parameters for one or more patients organized by patient and/or procedure.

Since the data is organized case/patient basis, the surgeon can easily generate new cases for the patient on the prescription software, with any input from the intra-operative software being pre-filled.

The prescription software may be accessed by any computing device communicatively coupled to the remote computing system 108. After completing the installation procedure of the external fixator 102, the surgeon may complete any remaining steps of the pre-fill prescription software program to create a strut adjustment plan or prescription for the patient. The strut adjustment plan may be stored by the remote computing system 108 and may be made accessible to other computing devices, as described further herein.

Fig. 3 illustrates an embodiment of a post-operative external fixation component tracking system 300. The post-operative external fixation component tracking system 300 can be used to track the relative position of the external fixation components of the external fixator after an installation procedure of the external fixator. Thus, the surgeon can monitor the patient's compliance with the strut adjustment plan and can provide modifications to the strut adjustment plan to the patient. Additionally, the surgeon may be provided with any information from the patient, including, for example, any notes, photographs, or reports, to implement a surgeon-patient feedback system that improves the patient experience and increases the likelihood of patient treatment success. As will be described in greater detail herein, the post-operative external fixation component tracking system 300 includes a tracking system. In use, the tracking system for the post-operative external fixed component tracking system 300 may be the same as or substantially similar to the tracking system 104 used in the post-operative external fixed component tracking system 100. However, as will be understood by those of ordinary skill in the art, the intraoperative external fixation component tracking system 100 and the postoperative external fixation component tracking system 300 may include different components (although they may also share many of the same components).

As shown in fig. 3, the post-operative external fixation component tracking system 300 may include an external fixator 102, a tracking system 104, a patient computing device 302, and a remote computing system 108. The patient computing device 302 may be any suitable computing device now known or hereafter developed including, for example, a smartphone, tablet, laptop, notebook, netbook, Personal Computer (PC), etc.

The tracking system 104 may communicate with the patient computing device 302 directly or indirectly through any known wireless communication standard or protocol. The patient computing device 302 may also communicate with the remote computing system 108 directly or indirectly through any known wireless communication standard or protocol. Exemplary wireless connections and/or protocols may include, for example, Wi-Fi (e.g., any ieee802.11a/b/g/n network), Bluetooth Low Energy (BLE), Near Field Communication (NFC), any cellular communication standard, any infrared communication protocol, and so forth.

In an embodiment, the remote computing system 108 may provide prescription software that determines a strut adjustment plan for the patient based on the installed external fixator 102. Further, the patient computing device 302 may provide a patient software application. The strut adjustment plan generated by the remote computing system 108 for the patient may be provided to a patient software application provided by the patient computing device 108. The strut adjustment plan may specify adjustments to be made to each strut 206 of the external fixator 102 over a period of time in which the external fixator 102 is expected to be worn by the patient.

In an embodiment, the patient software application may present the strut adjustment plan to the patient on a display of the patient computing device 302. Any modifications to the original strut adjustment plan may be provided from the prescription software to the patient software application and may also be presented to any user of the patient computing device 302. Additionally, any notifications related to the strut adjustment plan or any reminders to adjust the strut 206 may be provided from the prescription software to the patient software application. Alternatively, a reminder to adjust the strut 206 may be provided by the patient software application directly based on the stored strut adjustment plan.

In an embodiment, the adjustment to the strut 206 may be detected by the tracking system 104 and provided to a patient software application provided by the patient computing device 302. The patient computing device 302 may upload any detected adjustments to the strut 206 to the prescription software provided by the remote computing system 208. Detected adjustments to the strut 206 may be provided to a surgeon, medical caregiver, or any other authorized individual through the remote computing system 108, directly or through the use of any authorized computing device communicatively coupled to the remote computing system 108. In this manner, a surgeon, medical caregiver, or other authorized individual may monitor and track patient compliance with the strut adjustment plan. Additionally, any information uploaded by the patient to the remote computing system 108 may be reviewed to determine the overall progress or health of the patient with respect to the external fixator 102.

The post-operative external fixation tracking system 300 can display the length of the strut 206 to the patient post-operatively on the patient computing device 302 through the patient software application, thereby making the length value of the strut 206 easier to see and understand. For example, in one embodiment, the length of each strut 206 is displayed on the patient computing device 302 such that the current position of the strut 206 is more easily and better resolved than is available through any other length determining mechanism provided by the strut 206. That is, depending on the type of external fixator 102, it may be difficult for the patient to see the physical scale located on each strut 206 when making adjustments. Thus, it may be difficult for the patient to accurately adjust the relative position of the strut 206 according to the desired prescription. However, with the tracking system 104 and patient software, the patient may adjust the length of the strut 206 while viewing a user-friendly display that enables the adjustments to be made to the strut 206 to be more easily determined. Thus, any accidental and/or incorrect adjustment of any strut 206 may be avoided.

In addition, the incorporation of the tracking system 104 into the external fixator 102 enables a surgeon-patient feedback loop that does not rely on patient compliance with any software system that requires the patient to manually record adjustments to the strut 206. That is, in one embodiment, the tracking system 104 provides a surgeon-patient feedback loop during the adjustment phase of the treatment without requiring additional patient input. For example, the post-operative external fixation component tracking system 300 may actively monitor the position of the first and second external fixation components 202, 204 and/or the length of the strut 206, and may compare this information to the patient's prescription. The position of the first and second external fixation components 202, 204 and/or the length of the strut 206 may be provided directly from the tracking system 104 to the remote computing system 108 or may be provided indirectly through the patient computing device 302.

The detected position data and/or length data may then be monitored by a surgeon or other authorized individual through the remote computing system 108. Thus, the post-operative external fixation component tracking system 300 may directly and actively monitor the position of the first and second external fixation components 202, 204 and/or the length of the strut 206, thus eliminating the need for patient input of the length of the strut 206 or any associated incorrect reporting. In one embodiment, if the strut 206 is adjusted in a manner that matches or does not match the prescription, the surgeon and patient may be immediately notified through the software system described herein.

Thus, at the end of a surgical procedure to install external fixator 102, the patient may return home with the required prescription and instructions to adjust brace 206 according to the prescription. The tracking system 104 may remain coupled to the first and second external fixation components 202, 204, allowing the patient to monitor progress post-operatively. The patient software and/or the patient computing device 302 may store an electronic copy of the patient prescription that may be used to display updated lengths of the struts 206 as the struts 206 are adjusted by the patient. The patient software may also provide feedback to the surgeon through the prescription software and the remote computing system 108 so that the surgeon can post-operatively monitor the status of the patient's external fixator 102. If the adjustment to the strut 206 does not follow the prescription, the surgeon and patient can be immediately notified. Thus, the post-operative external fixation component tracking system 300 provides greater confidence to the patient and surgeon between clinical visits while simplifying the adjustment process.

Fig. 4 illustrates an embodiment of a user interface 400 provided by the patient computing device 302. The user interface 400 may be part of a display provided by the patient software. In one embodiment, the user interface 400 may be provided as patient software as a mobile application (app). The user interface 400 may provide information and/or instructions to the patient to adjust the length of one or more of the struts 206 of the external fixator 102 in a clear and concise manner, thereby improving the length adjustment process of the struts 206, thereby increasing the likelihood that the patient will comply with a prescribed strut adjustment plan.

As shown in fig. 4, the user interface 400 may include a first indicator 402 that indicates to the user interface 400 that a length adjustment to the strut 206 is specified. The user interface 400 may also include a second indicator 404 indicating the timing of the adjustment (e.g., which day the displayed adjustment was made). The user interface may also include a third indicator 406 that indicates that some length adjustment of the strut 206 is to be made. The first indicator 402, the second indicator 404, and the third indicator 406 may include any combination of textual and/or graphical components as shown.

The user interface 400 may include an icon or indicator 408 that indicates each individual strut 206 of the external fixator 102 along with corresponding instructions 410 for adjusting the length of each strut 410, if desired. For example, the first strut indicator 412 is associated with a first corresponding instruction 414 specifying that the second strut 206 is to be extended by 2 millimeters (mm). The second strut indicator 416 is associated with a second corresponding instruction 418 specifying that the third strut 206 is to be shortened by 2 mm. The third strut indicator 420 is associated with an indicator 422 that specifies that the fourth strut 206 is already at the correct length. First strut indicator 412, second strut indicator 416, and third strut indicator 420 may include any combination of numerical and graphical components as shown. The instructions 414 and 418 may include textual descriptions. The indicator 422 may be any graphical icon that indicates the correct length of the strut 206.

The indicators 408 and corresponding instructions 410 may be generated by the patient software based on real-time information provided by the tracking system 104 and based on information provided by the prescription software of the remote computing system 108. Once the struts 206 are appropriately adjusted according to the provided instructions 410, any textual instructions may be dynamically updated to the icon 422 to quickly and efficiently communicate to the patient that the particular strut 206 has been properly adjusted.

Fig. 5 illustrates an embodiment of a computing device 502. The computing device 502 may represent an embodiment of the local computing device 106 or the patient computing device 302. Accordingly, fig. 5 provides a block diagram of exemplary functional components of the local computing device 106 and/or the patient computing device 302.

Computing device 502 may include a wireless communication interface 504. The wireless communication interface 504 may provide an interface for communicating with any local or remote device or network via any wireless communication technology.

Computing device 502 may include a physical input interface 506 for interfacing with one or more physical inputs that may be manipulated by a user. The physical input interface 506 may include or may be coupled to various inputs including a keyboard, mouse, buttons, knobs, or any other type of user input feature or component, such as a touch screen. Physical input interface 506 may provide a way for a user to provide input to computing device 502.

The computing device 502 may include a display 508. The display 508 may include a visual display that may render visual information and a display controller for controlling the rendering of any visual information. The visual information may be any graphical or textual information. The display 508 may include a touch screen or a touch sensitive display. Accordingly, the display 508 may provide visual information to the user and/or may receive input from the user.

The computing device 502 may also include a processor circuit or controller 510 and an associated memory component 512. The memory component 512 may store one or more programs for execution by the processor circuit 510 to implement one or more functions or features implemented by the local computer device 106 and/or the patient computing device 302 as described herein. The processor circuit 510 may be implemented using any processor or logic device. The memory component 512 may be implemented using any machine-readable or computer-readable media capable of storing data, including volatile and non-volatile memory. Each component of the computing device 502 depicted in fig. 5 may be coupled to the processor circuit 510 as well as any other depicted components. The depicted components may be implemented in hardware or software, as appropriate, or any combination thereof.

As previously described, the computing device 502 may represent an embodiment of the local computing device 106. As such, the computing device 502 may implement and/or provide any of the features of the intraoperative software described herein. The computing device 502 may provide the intraoperative software as an application, as part of a network-based interface, or as an application resident on the computing device 502.

As a result of providing features and capabilities of the intraoperative software and/or the local computing 106, the computing device 502 may provide one or more of the following: receiving one or more inputs for determining a strut adjustment plan for a patient during a surgical procedure in which an external fixator is installed on the patient; receiving additional data related to the surgical procedure during the surgical procedure; storing, in a memory storage device, one or more inputs and additional data for determining a strut adjustment plan organized according to a patient identification associated with a patient and according to a procedure identification associated with a surgical procedure; displaying one or more inputs and additional data for determining a strut adjustment plan on the display 508; and transmitting one or more inputs and additional data for determining the strut adjustment plan to the remote device after completion of the surgical procedure.

The one or more inputs for determining a patient's strut adjustment plan may include a size and/or type of each external fixation component of an external fixator (e.g., external fixator 102) and/or a mounting location of each external fixation component of the external fixator. The one or more inputs for determining the strut adjustment plan for the patient may also include the type and/or length of each strut of the external fixation component attached to the external fixator. The length of each strut may be provided manually by user input (e.g., via a user interface provided by physical input interface 506). The length of each leg may also be provided automatically, wirelessly, and/or in real-time from the tracking system 104. The additional data received by the computing device 502 includes any type of textual data (e.g., notes) or visual data (e.g., photos or videos).

Any information received by computing device 502 may be stored by computing device 502 and/or transmitted to remote computing device 108. The remote computing device 108 may use any information from the computing device 502 to determine a strut adjustment plan for the installed external fixator. The computing device 502 and/or the remote computing device 108 may store and/or organize any received information based on a unique identifier of the patient (e.g., patient identification) and/or a unique identifier for the surgical procedure (e.g., surgical procedure identification).

The computing device 502 may use any information received regarding the external fixator's external fixator component positioning to guide the planning of the installation or configuration of the external fixator as described herein, for example, by displaying a visual representation of the planned external fixator on the display 508, displaying any calculated distances between the external fixator components, displaying any strut lengths of the calculated planned or configured external fixator, and/or displaying any indication of whether the planned or configured external fixator may require replacement of struts.

As previously described, the computing device 502 may represent an embodiment of the patient computing device 302. Thus, the computing device 502 may implement and/or provide any of the features of the patient software described herein. The computing device 502 may provide the patient software as an application, as part of a network-based interface, or as an application resident on the computing device 502.

The computing device 502 may receive real-time strut length data from the tracking system 104 due to the features and capabilities of the patient software and/or the patient computing device 302 being provided. The real-time strut length data may be provided on the display 508 for viewing by the patient. The computing device 502 may also provide the user interface 400 depicted in fig. 4.

FIG. 6 shows a block diagram of exemplary functional components of the tracking system 104. As shown, the tracking system 104 may include a first tracking system component 208 and a second tracking system component 210. The first tracking system component 208 may be coupled to a first external fixation component of an external fixator (e.g., external fixator 102). The second tracking system component 210 can be coupled to a second external fixation component of the external fixator. The first tracking system component 208 may include an optical sensor 606. The optical sensor 606 may be an optical camera. The second tracking system component 210 may be an LED target.

The first tracking system component 208 may include a wireless communication interface 608. The wireless communication interface 608 may provide an interface for communicating with any local or remote device or network via any wireless communication technology.

The first tracking system component 208 may also include a processor circuit or controller 610 and an associated memory component 612. The memory component 612 may store one or more programs for execution by the processor circuit 610 to implement any of the functions of the tracking system 104 as described herein. The processor circuit 610 may be implemented using any processor or logic device. The memory component 612 can be implemented using any machine-readable or computer-readable media capable of storing data, including volatile and non-volatile memory. Each of the first tracking system components 208 depicted in fig. 6 may be coupled to the processor circuit 610 as well as any other depicted components. The depicted components may be implemented in hardware or software, as appropriate, or any combination thereof.

The first tracking system component 208 may also include other additional components 614. The additional components 614 may be any type of electrical and/or mechanical component. In various embodiments, additional components 614 may include one or more additional sensors that may be incorporated into tracking system 104 to provide one or more additional measurements or functions, including the following types of sensors or functions that may be incorporated into tracking system 104: a temperature sensor; an RFID tag or reader; an accelerometer; a pedometer; a GPS receiver; a humidity sensor; a force sensor; a pressure sensor; a pH sensor; strain gauges and/or the ability to receive strain gauge data; ultrasonic healing capabilities, etc. may be incorporated. Additionally and/or alternatively, the tracking system 104 can include communication with a wearable device (e.g., Fitbit, etc.).

The first tracking system component 208 may also include a power supply 616. The power source may be any suitable power source for powering any electronic components of the tracking system 104, such as an internal power source, an external power source, an inductive charging system, a disposable battery, a rechargeable battery, a motion/inertial charging, and so forth.

In various embodiments, the tracking system 104 and/or any component thereof may be mounted to the first and/or second external fixation components 202 and 204 (as appropriate) using any suitable mechanism, including, for example, fasteners, adhesives, welding, and the like. Further, the tracking system 104 and/or any of its component parts may be mounted to any other part of the tracking system 104. For example, in one embodiment, the optical sensor 606 may be mounted to the first external fixation component 208 and the corresponding target may be mounted to the second external fixation component 210. Alternatively, the target may be mounted to the first external fixation component 208 and the optical sensor 210 may be mounted to the second external fixation component 210. Alternatively, one or both of the optical system 606 and the corresponding target may be mounted to one or more of the struts 206 or to another component of the external fixator 102. In various embodiments, components of the tracking system 104 may also serve as a fiducial for medical imaging.

The processor circuit 610 is operable to determine, in real time, position data indicative of a relative position between the first and second external fixation components based on data from the first tracking system component 208. For example, the first tracking-system component 208 may generate data indicative of a distance between the first tracking-system component 208 and the second tracking-system component 208. Data may be provided from the first tracking system component 208 to the processor circuit 610, which may in turn determine position data for the first and second external fixation components. The processor circuit 610 may then wirelessly transmit the determined location data to a remote device using the wireless communication interface 608.

As described herein, the tracking system 104 may be used intra-and/or post-operatively. Accordingly, the location data may be transmitted to a first remote device (e.g., local computing device 106) during a surgical procedure for installing an external fixator (e.g., to help guide or plan installation of an external fixator as described herein), and/or may be transmitted to a second remote device (e.g., patient computing device 302) after completion of the surgical procedure (e.g., to verify compliance with a strut adjustment plan associated with the external fixator).

During a surgical procedure, the determined position data may be used to determine a first mounting position of a first external fixation component and to determine a second mounting position of a second external fixation component during the surgical procedure. Further, the determined position data may be used to determine the length and type of each strut attached to the first and second external fixation components. The installation location and post type and length may be used to plan and/or complete the construction of the external fixator while minimizing any post replacement.

After the surgical procedure, the controller may determine a length of each strut attached to the first and second external fixation components. The determined strut lengths may be provided to, for example, the patient computing device 302 to facilitate compliance with a strut adjustment plan as described herein.

Note that while the various software applications (e.g., intraoperative software application, prescription software application, and patient software application) are described as separate software applications, it is contemplated that they may be fully integrated software systems that allow for easy transfer and/or access of data therebetween. Capturing prescription software input with an intraoperative software application significantly reduces the post-operative time required for a surgeon to manually enter the information required by the prescription software.

In one embodiment, in use, the intraoperative software application can link to any system for intraoperative measurement of strut length or loop position, and can include one or more of the following combinations of functions: prescription software input, prescription software input and remarks, prescription software input and photos, prescription software input and connectivity to sensor technology, prescription software input, remarks and photos, prescription software input, remarks, photos and connectivity to sensor technology, and the like.

While the present disclosure sets forth certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claims. Accordingly, it is intended that the disclosure not be limited to the described embodiments, but that it have the full scope defined by the language of the following claims, and equivalents thereof. The discussion of any embodiment is meant to be illustrative only, and is not intended to intimate that the scope of the disclosure, including the claims, is limited to those embodiments. In other words, although illustrative embodiments of the present disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise embodied and used, and that the appended claims are intended to be construed to include such variations unless limited by the prior art.

The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. For example, various features of the disclosure are grouped together in one or more embodiments or configurations for the purpose of streamlining the disclosure. It should be understood, however, that various features of certain embodiments or configurations of the present disclosure may be combined in alternative embodiments or configurations. Furthermore, the following claims are hereby incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the disclosure.

As used herein, an element or step recited in the singular and proceeded with the word "a/an" should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. Furthermore, references to "one embodiment" of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

As used herein, the phrases "at least one," "one or more," and/or "are open-ended expressions that combine and separate in operation. The terms "a" (or "an"), "one or more" and "at least one" are used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, upper, lower, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. Joinder references (e.g., joined, attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members that move between and relative to a collection of elements unless otherwise indicated. Thus, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. All rotational references describe relative movement between various elements. Identifying references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but rather are used to distinguish one feature from another. The drawings are for illustrative purposes only and the dimensions, positions, order, and relative sizes reflected in the drawings of the present invention may vary.