Patent Application
20160310297
During orthopedic procedures such as knee replacement or similar joint reconstruction surgeries, various tools and instruments are used to assist with the various procedures, including the use of force sensors built into provisional or trial implant prosthetics to assist surgeons in balancing soft tissues. For example, during a conventional total knee arthroplasty (TKA) procedure provisional components can be placed on the distal end of the femur and proximal end of the tibia to confirm proper sizing and fit. Provisional components come in a wide variety of sizes and shapes to match the permanent components of the final implant. In some examples, the provisional or trial components can have force sensing components designed in to further assist the surgeon in determining the proper size, orientation, and configuration of the permanent components. The eLIBRA Dynamic Knee Balancing System from Zimmer of Warsaw, IN is an example of knee trialing instrumentation that includes designed in force or pressure sensing capabilities for assisting in balancing soft tissues in the knee. An example of the eLIBRA Dynamic Knee Balancing system is detailed in U.S. Pat. No. 7,442,196.
Assemblies, configurations, and methods of use for a universal force sensor module usable across a wide range of medical device applications. In an example, the universal force sensor module provides a convenient, compact, and self-contained module that can be interchangeably inserted into a range of devices, such as trial prosthetic devices for various joint reconstruction surgeries. The self-contained sensor module is battery operated and wirelessly communicates with an external computing device to provide force information within the trial prosthetic. An external computing device can perform complex calculations, render graphical interfaces, and store surgical information related to force data provided by the self-contained sensor modules. The sensor modules are designed to enable an external computing device to monitor multiple individual sensor modules concurrently, allowing a trial prosthetic to include as many individual sensor modules as necessary to provide the surgeon with useful soft tissue or joint operation information while in place. Obtaining data from multiple locations within a joint can enable an external computing device to perform additional calculations based on known relationships between the sensor locations within the joint. The universal sensor modules provide a simple single device for integration into a wide range of trial or provisional prosthetics or other instrumentation without the need to design specific trials or provisionals with force sensing integrated into the devices. The use of interchangeable universal sensor modules simplifies inventories and use in the surgical setting.
The present inventors have recognized, among other things, that the currently available force sensing devices require a high degree of initial design for each variation of trial or provisional prosthetic and require instrument kits or systems to contain multiple expensive sensor integrated provisionals to accommodate various provisional types (ex: level of implant constraint) or different sizing, which deters use and adoption of force sensing for joint reconstruction and other similar procedures. These problems, and others, are solved by the present invention through the ability to integrate compact universal force sensing modules into a wide variety of provisional prosthetics, while only requiring a limited number of sensor modules to be included within a surgical kit or system. Separating the force sensing circuitry into self-contained modules limits the need to include expensive circuitry across the entire range of provisional prosthetics and may provide greater control and calibration of the individual force sensing components. Use of individual sensor modules also provides a surgeon options for when and how to use force sensing within any given procedure, if force sensing is not needed the surgeon can simply insert a plug in place of the universal sensor module. Additional benefits arising from the present subject matter will be obvious to one of ordinary skill in the art when reading the remainder of the detailed description.
The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
Example 1 can include a universal force sensor module. The universal force sensor module can include an upper module cover including a cover flex section. The universal force sensor module also includes a module base including a sensor support structure, the module base configured to receive a cover perimeter section of the upper module cover. The universal force sensor module further includes a force sensor disposed within the module base and supported by the sensor support structure, and a circuit board electrically coupled to the force sensor and a battery, the circuit board and battery disposed within the module base.
In Example 2, the universal force sensor module of example 1 can optionally include a cover flex section with a reduced thickness portion surrounding a cover instrument contact surface.
In Example 3, the universal force sensor module of example 2 can optionally include a reduced thickness portion of the cover flex section that allows for micron-level defections in the cover instrument contact surface in a direction substantially perpendicular to a plane formed by the outer upper surface of the upper module cover.
In Example 4, the universal force sensor module of any one of Examples 1 and 3 can optionally include an upper module cover that further includes a sensor interface structure disposed on the inside surface and configured to contact the force sensor.
In Example 5, the universal force sensor module of example 4 can optionally include a sensor interface structure with a sensor cover contact for contacting the force sensor.
In Example 6, the universal force sensor module of any one of examples 4 or 5 can optionally include a sensor cover contact that produces an interference fit with the force sensor when the upper module cover is joined with the module base.
In Example 7, the universal force sensor module of any one of examples 1 to 6, can optionally include an upper module cover with an instrument contact surface covering a portion of an outer surface of the upper module cover.
In Example 8, the universal force sensor module of example 7 can optionally include a cover flex section with a thin walled section corresponding to the instrument contact surface.
In Example 9, the universal force sensor module of any one of examples 7 and 8 can optionally include an instrument contact surface with a narrower medial/lateral dimension in comparison to a anterior/posterior dimension.
Example 10 can include a surgical system comprising a universal force sensor module and a trial prosthesis. In this example, the universal force sensor module can include an upper module cover, a module base, a force sensor, and a circuit board. In this example, the module base can include a sensor support structure and be configured to receive a cover perimeter section of the upper module cover. The force sensor can be disposed within the module base and be supported by the sensor support structure. The circuit board electrically can be coupled to the force sensor and a battery, and the circuit board and the battery can be disposed within the module base. The trial prosthesis can include a sensor module cavity adapted to securely retain the universal force sensor module.
In Example 11, the surgical system of example 10 can optionally include a set of trial prosthesis each including a sensor module cavity adapted to securely retain the universal force sensor module.
In Example 11, the surgical system of any one of examples 10 or 11 can optionally include a handling instrument adapted to insert the universal force sensor module into the sensor module cavity in the trial prosthesis.
In Example 13, the surgical system of example 12 can optionally include a handling instrument with a plurality of engagement tabs adapted to engage handling scallops in the module base of the universal force sensor module, and a stabilizer adapted to engage at least a portion of the upper module cover when the plurality of engagement tabs are engaged with the handling scallops.
In Example 14, the surgical system of any one of examples 12 or 13 can optionally include a handling instrument with a locking mechanism to positively capture the universal force sensor module.
In Example 15, the surgical system of example 14 can optionally include a locking mechanism with a ratchet-type mechanism to provide various degrees of pressure on the universal force sensor module.
In Example 16, the surgical system of any one of examples 10 to 15 can optionally include an articular insert adapted to fit over the universal force sensor module within the sensor module cavity to provide a substantially uniform articular surface over a portion of the trial prosthesis.
In Example 17, the surgical system of any one of examples 10 to 16 can optionally include a computing device. In this example, the computing device can include one or more processors for processing data and generating a graphical user-interface, a communication circuit for wirelessly communicating with one or more universal force sensors including the universal force sensor module, and a display device for displaying the graphical user-interface.
In Example 18, the surgical system of example 17 can optionally include a graphical user-interface with numeric and graphical information related to the universal force sensor module.
In Example 19, the surgical system of any one of examples 17 or 18 can optionally include a communication circuit adapted to communicate with the one or more universal force sensors over a Bluetooth communication protocol.
Example 20 can include a surgical instrument for determining forces within a joint. The surgical instrument of this example can include an instrument housing and a universal force sensor module disposed within one of the one or more force sensor module cavities. The instrument housing can include one or more force sensor module cavities, and the instrument housing can be configured to position the one or more force sensor module cavities within the joint. In this example, the universal force sensor module can include an upper module cover, a module base, a force sensor and a circuit board. The module base can include a sensor support structure and be configured to receive a cover perimeter section of the upper module cover. The force sensor can be disposed within the module base and be supported by the sensor support structure. The circuit board can be electrically coupled to the force sensor and a battery, the circuit board and battery disposed within the module base.
This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
Detailed structure, configurations, and methods of use for a universal force sensor module, associated instruments, and provisional components are generally disclosed herein. In one example, a universal force sensor module includes a force sensor, a circuit board, one or more batteries, and a specially designed housing. In another example, provisional components for using universal force sensor modules within knee, hip, or other joint reconstruction surgeries are discussed. For example, during total knee arthroplasty (TKA), a surgeon can use one of the provisional tibial implant assemblies in conjunction with universal force sensors discussed herein to balance soft tissues within a knee before making final resections of the femur and/or tibia. Similarly, universal force sensor modules can be used within an acetabular cup trial component discussed herein verify proper femoral head length or other parameters of a total hip arthroplasty (THA) procedure.
The following definitions are provided solely to assist the reader in understanding the following detailed description of various examples illustrated by the included figures.
Provisional: A provisional component or assembly is a component or assembly that is similar in shape and fit to the actual implant (prosthesis) that will be used to complete the surgical procedure.
Trial component: A provisional type component or assembly typically provided as part of a surgical kit or system and including multiple different sizes or thickness to assist in determining size of a prosthetic implant to be used as part of a joint reconstruction.
In the example illustrated in
Further illustrated in
In an example, the module base 150 includes a cross-beam (sensor support structure) 152 to provide a solid stable structure under the force sensor 120. The module base 150 also includes handling scallops 154 on at least two ends of the module base 150 to ease handling of the relatively small device with handling instruments discussed below in reference to
In an example, the handling forceps 200 include a locking member 215 designed to engage when a sensor module is secured within the engagement tabs 225. In some examples, the locking member 215 is a ratchet-type locking member that can produce progressively higher amounts of force on the engagement tabs 225 as the manipulation grips 205 are squeezed. A ratchet-type locking member includes multiple lock engagement points or ridges.
Prosthesis and Instruments for Use with Universal Force Sensor Module(S):
The sensor switches 710 activate the sensor readouts 720 for the selected sensor. In some examples, the universal force sensor modules can be named as they are connected to the host computing device. In these examples, the GUI 700 can report the names of the individual sensor modules allowing the user to better understand which sensor modules are being controlled or readout.
The Green Zone area of the GUI 700 controls the color of the sensor readouts 720 based on the force or pressure reading received from the corresponding universal force sensor module. When activated via green zone switch 730, the Green Zone controls enable a user to set upper and lower bounds for sensor readings via the green zone range controls 740. The lower bound is controlled via the green zone low control 750 and displayed within a combination of green zone low range 742 and green zone acceptable range 744. Similarly, in this example, the upper bound of the green zone is controlled through manipulation of the green zone high control 755 and displayed through a combination of the green zone high range 746 and the green zone acceptable range 744.
The Difference area of the GUI 700 provides a different control over the behavior of the sensor readouts 720. The Difference area enables a visual indication or other form of alert (pop-up, audible, etc . . . ) based on a detected difference in force readings from enabled universal force sensor modules. When activated via difference switch 760, the difference range controls 770 allow a user to select the desired limits on difference between sensor module readings. In this example, the difference range controls 770 include a difference acceptable range 772, a difference high range 774, and a difference control 780. The difference control 780 in this example is a slider control that allows for setting a maximum acceptable difference between sensor readings. In another example, not illustrated, the difference controls 770 can include controls to select specific universal force sensor modules to include in the difference calculations. Additionally, examples can optionally also include multiple sets of difference controls 770 to enable different difference settings for different pairs of sensors, for example.
In this example, the method 800 optionally begins at 810 with a member of the surgical team sterilizing the force sensor module. As the force sensor modules will typically be pre-sterilized single use devices, operation 810 may be unnecessary in most example procedures. However, as sterilization methods and materials for use in manufacturing a force sensor module, such as the universal force sensor module 100, advance multiple use devices are envisioned. At 820, the method 800 continues with a member of the surgical team using a handling instrument, such as handling forceps 200, to insert the force sensor module into a provisional prosthesis, such as the provisional tibial insert 400A. At 830, the method 800 continues with the inserted force sensor module being communicatively connected to a computing device hosting a GUI for monitoring data sent by the force sensor module. In an example, connecting the force sensor module can involve a Bluetooth or near-field communication (NFC) pairing operation. In another example, the force sensor module can be configured to automatically detect and connect to a host computing device over Bluetooth, NFC, Wifi, or some similar wireless networking protocol.
Once connected, the method 800 continues at 840 with the surgical team performing the intended surgical procedure, or at least the portion of the procedure involving the provisional prosthesis with force sensor module inserted. During the procedure, the method 800 continues at 850 with the surgical team monitoring data transmitted from the force sensor module to the host computing device via the GUI. As described above, the GUI 700 provides both numeric and visual feedback to the surgical team based on forces sensed by the one or more force sensors being monitored. The numeric and visual feedback is used by the surgical team to modify aspects of the procedure to obtain a more favorable outcome for the patient. Finally, method 800 can conclude at 860 with a member of the surgical team removing the force sensor from the provisional prosthesis.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive.
For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/150,968, filed on Apr. 22, 2015, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62150968 | Apr 2015 | US |
