Foot control device, system and method for surgical instrument control

Abstract

A foot control device, system and method for control of surgical instruments is disclosed. The device attaches to a surgeon, or is otherwise incorporated into footwear worn by a surgeon. The device contains a sensor for detecting specific foot motions (gestures) which are in turn processed by a computer containing a gesture library or data set that correlates specific foot gestures with specific activation commands for control of a number of different surgical instruments.

Description

[0001] FOOT CONTROL DEVICE, SYSTEM AND METHOD FOR SURGICAL INSTRUMENT CONTROL

[0002] CROSS REFERENCE TO RELATED PATENT APPLICATIONS

[0003] This application claims priority to United States Patent Application Serial No. 63 / 529,031 filed July 26, 2023 entitled “Foot Control Device, System and Method For Surgical Instrument Control” by Stone et al., the entire disclosure of which is incorporated herein by reference as permissible by national or regional laws.

[0004] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0005] None

[0006] Docket No. URMC574 23048

[0007] TECHNICAL FIELD

[0008] The present invention relates generally to surgical equipment, and more particularly to a foot control device, system and method for surgical instrument control.

[0009] Docket No. URMC574 23048

[0010] BACKGROUND ART

[0011] The modem day operating room is a hectic environment. Technology has become common place and more advanced with every surgical specialty, with new machines, instruments, and other gadgets surrounding the patient with the hope of providing cutting edge care and more advanced procedures with improved outcome for the patient. This infusion of technology has also resulted in challenges for the surgeon who is now faced with working in an ever-smaller personal space as the lines, tubes, and cords of the various instruments fence in the hallowed space around the patient.

[0012] Many of these numerous and often specialized surgical instruments are now operated with foot control pedals to free up the surgeon’s hands for surgical operations. This, however, results in numerous foot control pedals on the floor of the operating room. To identify the required foot control pedal prior to use, the surgeon oftentimes must break their eyes from the surgical field to look down on the ground in order to identify the appropriate device or pedal. Often the sterile drapes need to be moved to have visualization of the floor where any one of multiple pedals are located, with the correct pedal being physically brought forward so that it can be used. These actions put the sterile environment at risk by way of an unsterile headlight or reliance on a circulating nurse, who in a dehumanizing way gets down on her hands and knees to a blood soaked floor to locate and isolate the correct pedal.

[0013] In place of these activities to locate the correct pedal, some surgeons use the “discovery tap”, where a foot is placed underneath the sterile drapes, and the surgeon lightly taps the floor, mapping it out until the correct pedal is found. This often leads to pulling off the sterile drapes or activating multiple different instruments until the correct one is found.

[0014] What is therefore needed is a way to minimize the number of disparate surgical control pedals in an operating room. Docket No. URMC57423048

[0015] DISCLOSURE OF THE INVENTION

[0016] In accordance with the present invention, there is provided a foot control device, system and method for control of surgical instruments. The foot control device attaches to a surgeon, or is otherwise incorporated into footwear worn by a surgeon. The device contains a sensor for detecting specific foot motions (gestures) which are in turn processed by a system that comprises a computer containing a gesture library or data set that correlates specific foot gestures with specific activation commands for control of a number of different surgical instruments. The foregoing has been provided by way of introduction, and is not intended to limit the scope of the invention as described by this specification and the attached drawings and claims.

[0017] Docket No. URMC574 23048

[0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The invention will be described by reference to the following drawings, in which like numerals refer to like elements, and in which:

[0020] Figure 1 depicts a foot control device for surgical instruments according to an embodiment the present invention;

[0021] Figure 2 depicts a foot control device for surgical instruments according to another embodiment of the present invention;

[0022] Figure 3 depicts a foot control device for surgical instruments according to a further embodiment of the present invention;

[0023] Figure 4 is a block diagram of a system of the present invention;

[0024] Figure 5 depicts a foot control device mechanical interface;

[0025] Figure 6 depicts a further embodiment of the foot control device mechanical interface; and

[0026] Figure 7 is a flowchart depicting a method of the present invention.

[0027] The present invention will be described in connection with a preferred embodiment, however, it will be understood that there is no intent to limit the invention to the embodiment described. On the contrary, the intent is to cover all alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by this specification, drawings and claims attached hereto. Docket No. URMC574 23048

[0028] BEST MODE FOR CARRYING OUT THE INVENTION

[0029] To address the unmet need previously described, the following discloses a foot control device for surgical instruments where a single foot control device can control a plurality of disparate surgical instruments.

[0030] A device that is worn on a surgeon’s footwear or otherwise incorporated therein is disclosed, along with the underlying system and methods therein. The device communicates with surgical instruments in the operating room using stereotyped foot movements by the surgeon. The surgeon employs foot movements that are specific to each instrument used in a surgical procedure. These stereotyped foot movements, also referred to herein as gestures, will activate or deactivate each specified instrument. This will allow the surgeon to have access to instrument control without needing to break attention from the surgical field, utilize operating room staff, or perform “discovery taps” to locate the specific foot control needed.

[0031] The device has a housing that is configured with a geometry and attachment attributes that are specific to the way in which the device is worn. For example, a foot control device that is worn on footwear may contain hook and loop fasteners, eyelets or other such features to attach to laces of a shoe, magnetic fasteners, clips, or the like. Internally, the foot control device contains a movement sensor such as a pedal, switch, sensor, gyroscope, accelerometer or the like which in turn activates a specified surgical instrument once a specific foot movement occurs, such as tapping or moving the foot in a certain direction or pattern. The same or another foot movement in turn deactivates the specified surgical instrument or causes the instrument to enter another operating mode (i.e., reverse, lower speed / power, higher speed / power, or the like). Given the current low cost state of accelerometers due to the proliferation of these devices in smart phones, an accelerometer may be a preferred choice, but the present invention as described herein is not limited to an accelerometer as a means of movement detection. The movement sensor is capable of providing not only a binary signal, but also duration, frequency and direction of foot motion. In some embodiments, multiple movement sensors may be employed to provide further information regarding foot movement, as foot movement by the user (the medical practitioner in some cases) serves as a language of sorts, allowing specific foot movements to be interpreted as instructions for activation and control of the surgical instruments that are Docket No. URMC574 23048 connected with or otherwise associated with the foot control device and system of the present invention.

[0032] A controller provides the interface between the foot control device and the surgical instruments that are being controlled by the foot control device. In addition, a receiver that receives a wireless signal from the foot control device is connected with the controller or integrated therewith.

[0033] In some embodiments of the present invention, voice activation / voice recognition is used in conjunction with foot control to activate, deactivate and control surgical instruments.

[0034] In some embodiments, the controller controls mechanical actuators that interface with the foot control for each surgical instrument under the control of the foot control device, providing a mechanical interface between the foot control device and the control pedals that are currently being used with the various surgical instruments in the operating room. In other embodiments, the interface between the foot control device and each surgical instrument is an electrical interface where foot motion and gestures emulate control pedal actions. Further, in some embodiments of the present invention the signals from the foot control device are received by a surgical instrument that has an internal controller or interface contained therewith.

[0035] Turning now to the drawings, Figure 1 depicts a foot control device for surgical instruments 101 in use (100) and attached to footwear 103, in this example a shoe of a surgeon. The foot control device is preferably of a compact geometry, and has a housing made from a preferably lightweight material such as a plastic or a thin or lightweight metal such as aluminum. Within the foot control device is a movement sensor for detecting motion preferably along all three axis of motion. The movement sensor may be a gyroscope, an accelerometer, an infrared sensor, a proximity sensor, an RF tomographic motion sensor, a light sensor, an ultrasonic sensor, a machine learning gesture sensor, or the like. The output of the movement sensor may be analog or digital. In the case of an analog output, an appropriate analog to digital converter is employed to convert axis specific motions to a digital signal where the digital signal is then sent to a computer processor. Motion specific information may include axis of motion, acceleration, velocity, repetition or pattern of motion(s), and the like such that a motion specific data set can be used to identify an intended control action by the surgeon. An intended control action may include, but is not limited to, control of a surgical instrument. Other control actions, without intending to limit the applications by which the present invention may be used, may include, for Docket No. URMC574 23048 example, control of a video input or output, control of a light source, control of a voice recording function, control of computer equipment, and the like.

[0036] A computer processor is digitally connected to the movement sensor either through a direct hardwired connection or through a wireless connection in cases where the computer processor is not contained within the foot control device. An appropriate analog to digital converter may also be employed as necessary to translate any analog outputs from the movement sensor into digital outputs that may be read and understood by the computer processor. It should be noted that in some embodiments, a microprocessor or microcontroller is contained in the housing of the foot control device with an outboard computer wirelessly connected to the microprocessor or microcontroller. The wireless connection may be a transmitter configured to transmit information about movement of the device to a receiver that may in turn be connected to another computer, computer system, or network. Such an arrangement would allow for storing, categorizing and processing received foot gestures to improve the accuracy of identifying a received foot gesture with a known foot gesture.

[0037] Figure 2 depicts a foot control device for surgical instruments 201 in use according to another embodiment of the present invention where the device is attached to a sole of a shoe 103 rather than the laces of the shoe. It should be noted that there are numerous ways to attach the foot control device to footwear, and in some embodiments the foot control device may be built in, integrated with or otherwise attached to the footwear. In the embodiment depicted in Figure 2, the foot control device for surgical instruments 201 operates by sensing foot movement, in this embodiment including contact of the shoe 103 to a floor or other surface. Contact may be determined by way of a switch, a button, a proximity sensor, a capacitive sensor, an accelerometer, a gyroscope, a pressure sensor, or the like. As such, the system of the present invention may determine and count taps of the foot onto the floor or other such surface where the number of taps translate to specific surgical instrument control actions.

[0038] Figure 3 depicts a foot control device for surgical instruments 301 in use according to another embodiment of the present invention where the device is attached to a leg or ankle of a surgeon or other medical practitioner rather than a surgical shoe. The foot control device for surgical instruments 301 is attached to the leg or ankle of a surgeon or other medical practitioner by way of a strap or similar apparatus. In this embodiment, the foot control device for surgical instruments 301 senses foot or leg movement as previously described herein, but also may, in Docket No. URMC574 23048 some embodiments, monitor vital signs of the surgeon or other medical practitioner such as heart rate, blood pressure, body temperature, and the like.

[0039] The foot control device of the present invention may, in some embodiments, be part of a system and may include method steps that allow for further novel functionality as described and envisioned herein.

[0040] While Figures 1-3 depict several exemplary embodiments of the foot control device of the present invention, other means of attaching the foot control device of the present invention to footwear or anatomy of a medical practitioner to allow for the action of foot gestures by the medical practitioner and associated control of a surgical instrument can be readily envisioned after reading this specification, and are considered to be included in the scope and content of the present invention.

[0041] Figure 4 is a block diagram of a system of the present invention 400 showing the various components that make up a typical system for controlling surgical instruments in accordance with the present invention. The foot control device 401 (similar to 101, 201 or 301) can be seen in wireless communication with a receiver 403. The wireless connection between the foot control device 401 and the receiver 403 may include any known transmission frequency, band, modulation, power, or the like. A close range communication protocol such as Bluetooth may, for example, be employed. In some embodiments of the present invention, the wireless connection may be radio frequency or may be optically based. A computer 405 can be seen in digital communication with the receiver 403. The computer 405 has a processor, memory, and access to computer readable media and is capable of executing software that comprises the steps of receiving a foot gesture on a foot control device, processing the received foot gesture, comparing on the computer the received foot gesture with a known set of foot gestures, and providing with a controller 409 a gesture specific control action to a surgical instrument. The known set of foot gestures may be contained in a gesture library where surgical instruments and their related control actions are mapped to foot gestures. The library or libraries may be contained within, or a subset of, a database or other data structure. The foot gestures include, but are not limited to, axis of motion, acceleration, velocity, repetition or pattern of motion(s), and the like, and are translated to surgical instrument control actions. The controller 409 provides a signal or signals to each control device 411, 415 that is associated with a surgical instrument 413, 417. At least one control device and one surgical instrument makes up a typical system. In Docket No. URMC574 23048

[0042] Figure 4, two control elements and two surgical instruments are depicted. Often, there are more than two control devices and two surgical instruments in a typical system. The control device may be digital or analog. A digital control device converts gesture specific commands, as sent by the controller 409, into commands that can be understood by the specific surgical instrument that it is connected with. These commands are often commands that would otherwise be received from a foot control pedal associated with that surgical instrument. The controller 409 may, in some embodiments, include multiple controllers or a controller for each surgical instrument.

[0043] In some embodiments, voice recognition (VR) 407 or speech recognition is employed to direct control of the surgical instruments either in place of, or to supplement, control from the foot control device. Such functionality is resident on a computer or computer networks either inside our outside of the system described herein.

[0044] In some embodiments, a safety filter is employed to differentiate between valid foot gestures and extraneous foot gestures. The safety filter may be software based, and may be produced and updated through a gesture library that collects, analyzes and improves upon gesture reception, mapping and translation. This improvement process may be continuous, and may, in some embodiments, be networked or otherwise collectively processed to allow for a larger population size and resulting greater improvements. Such safety filter software may contain foot gesture parameter upper and lower boundaries, and may be continuously improved through the processes previously described. Artificial Intelligence (Al) functionality may contribute to the operation of the safety filter in some embodiments of the present invention.

[0045] In some embodiments, a feedback device is provided. The feedback device is configured to provide feedback to a user of the system for controlling surgical instruments, wherein the feedback device may include a haptic device, an optical device, an audible device, a sensory device, a voice prompt device, a computer display device, or the like. A haptic device, for example, may further include an attachment member for attaching the haptic device to clothing or equipment of a surgeon. The feedback device gives return communication to the medical practitioner that an action has been performed in accordance with the foot gesture delivered to the system. For example, if a medical practitioner performs a foot gesture to request that a specific surgical instrument is turned on, the feedback device would provide confirmation that Docket No. URMC574 23048 such an action was taken. For example, if the feedback device were a haptic device worn by the medical practitioner, feedback would be in the form of a vibration or other indicator.

[0046] While the feedback device may be a visual or audible indicator such as a light, readings on a computer display, or an audible indicator such as a tone generator, in some embodiments feedback that does not otherwise disturb the operating room environment is desired. Such a feedback device may include a haptic device such as a vibrating device that the medical practitioner wears. Such vibrating devices are known, for example, in the field of smart phones where a small motor and an offset cam are employed to cause vibration.

[0047] In some embodiments of a system of the present invention, an analog control device is employed that utilizes a mechanical interface to operate a surgical instrument through the surgical instruments existing control interface. Examples of such an interface are depicted in Figures 5 and 6. The analog control device receives commands that have been generated from the conversion of foot gestures to electrical signals, as previously described herein. The analog control device interfaces with a foot control device mechanical interface 500 as depicted in Figure 5. The foot control device mechanical interface 500 comprises a cabinet with a first device enclosure 501, and often additional device enclosures such as the second device enclosure 503 depicted in Figure 5. The existing foot control device pedal 505 is still connected to the surgical instrument in this embodiment, and a mechanical actuator 507 such as a solenoid, linear actuator, hydraulic or pneumatic actuator, or the like is located in a device enclosure and positioned such that the mechanical actuator 507 makes contact with and operates the existing foot control device pedal 505. In some embodiments, an optional visual display indicator 509 provides the status of each device under control. Such an arrangement allows the foot control device of the present invention to control and operate surgical instruments without the need for the development of an electrical interface between the present invention and an existing surgical instrument control arrangement.

[0048] Figure 6 depicts a further embodiment of the foot control device mechanical interface 600 showing a first device enclosure 601 with an existing foot control device pedal 603 and a mechanical actuator 605 positioned above the foot control device pedal 603. In some embodiments, there may be a plurality of actuators to control either various instruments or multiple control points on the same instrument. Docket No. URMC574 23048

[0049] A visual indicator 607 can also be seen that optionally displays the status of each surgical instrument under control. Such a visual indicator may be, for example, a flat panel display such as an LED or OLED display.

[0050] Actuators 609 can also be seen that engage with and move control elements on a surgical instrument. For example, a solenoid, linear actuator, hydraulic or pneumatic actuator may be employed to engage with and control the surgical instrument. In some embodiments, additional fixturing may be employed to facilitate a proper mechanical connection between the actuators 609 and the surgical instruments under control.

[0051] Figure 7 is a flowchart depicting a method of the present invention. The method may, in some embodiments, be computer based, and comprises the steps of receiving a foot gesture on a foot control device (701), processing on a computer the received foot gesture which includes accessing a gesture library (707) where the gesture library 709 has been previously described herein and contains a known set of foot gestures, comparing on the computer the received foot gesture with a known set of foot gestures and providing with a controller a gesture specific control action to a surgical instrument (711). The gesture specific control action may include turning a surgical instrument on or off, increasing or decreasing the speed of the surgical instrument, increasing or decreasing the power of the surgical instrument, switching the instrument to be controlled, and the like.

[0052] Once the gesture specific control action has been provided to the surgical instrument, feedback is provided (705). Feedback may be simply the operation of the surgical instrument, or may include audible, visual, haptic, sensory, voice, or computer based feedback. In some embodiments, an optional safety filter (703) is configured to differentiate between valid foot gestures and extraneous foot gestures. Such a filter 703 contains validation rules to provide for such differentiation.

[0053] In some embodiments of the present invention, the received foot gesture is categorized and processed on the computer to improve the accuracy of identifying a received foot gesture with a known foot gesture. Such an advanced learning or artificial intelligence arrangement allows for storing, categorizing and processing received foot gestures to improve the accuracy of identifying a received foot gesture with a known foot gesture. For example, a simple foot tap may have a spectrum of acceleration or force attributes that are somewhat unique to a user. By collecting data on the variety of attributes that may be encountered from various users and Docket No. URMC574 23048 setting accept and reject parameters based on the collected data allows the system of the present invention to filter out unintentional foot gestures that were either not performed or were inadvertent or unintentional foot movements not performed with the intention of controlling a surgical instrument.

[0054] The foot gesture, as previously described herein, may include motion of the foot in any of a plurality of directions or forms such as, but not limited to, tapping of the foot, side to side motion of the foot, shaking of the foot, and the like. The optional safety step 703 provides for the comparison of a received foot gesture to a known set of parameters for that foot gesture, and may, in some embodiments, be performed in parallel with, or out of sequence with, accessing a gesture library in step 707 and mapping the received foot gesture with entries in the gesture library to determine what gesture specific action to take in step 711. The gesture specific actions are typically control actions such as on / off, increase / decrease speed, increase / decrease power, and the like and are typically performed in the feedback step 705.

[0055] Further, in some embodiments, foot gestures may be used for security purposes such as logging on to a system or identifying a user or a particular piece of equipment or even identifying a medical procedure or a patient. Further, in some embodiments, some surgical instruments or equipment can only be accessed or operated by authorized users. As such, foot gestures may be employed as a way to securely activate and use a specific surgical instrument or piece of equipment.

[0056] The ability to control surgical instruments and equipment without using hands and without the need for a tangled mess of wires and foot control pedals under the operating table has been described herein, and addresses a previously unmet need in the operating room.

[0057] It is, therefore, apparent that there has been provided, in accordance with the various objects of the present invention, a foot control device, system and method for surgical instrument control.

[0058] While the various objects of this invention have been described in conjunction with preferred embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of this specification, drawings and claims appended herein.

Claims

Docket No. URMC574 23048What is claimed is:

1. A foot control device for surgical instruments comprising: a housing, an attachment member for retaining the foot control device to a foot or an ankle of a medical practitioner, a movement sensor contained in the housing for detecting movement of the device, a computer processor connected to a direct or an indirect digital output of the movement sensor, and a transmitter contained in the housing and connected to the computer processor, wherein the transmitter is configured to transmit information about movement of the device to a receiver, and wherein the receiver is configured to receive the information about movement of the device from the transmitter and is operatively coupled to at least one surgical instrument for control of the at least one surgical instrument.

2. The foot control device for surgical instruments as recited in claim 1, wherein the sensor is selected from the group consisting of a gyroscope, an accelerometer, a switch, an infrared sensor, a proximity sensor, an RF tomographic motion sensor, a light sensor, an ultrasonic sensor, a machine learning gesture sensor.

3. The foot control device for surgical instruments as recited in claim 1, wherein the receiver and the at least one surgical instrument are wirelessly coupled.

4. A system for controlling surgical instruments comprising: a foot control device for surgical instruments comprising a housing, an attachment member for retaining the foot control device to a foot or an ankle of a medical practitioner, a movement sensor contained in the housing for detecting movement of the device, a computer processor connected to a direct or an indirect digital output of the movement sensor, and a transmitter contained in the housing and connected to the computer processor, wherein the transmitter is configured to transmit information about movement of the footwear to a receiver;Docket No. URMC574 23048 the receiver configured to receive the information about movement of the device from the transmitter; a computer in digital communication with the receiver; a controller in digital communication with the computer; at least one control device in communication with the controller; and at least one surgical instrument in communication with the at least one control device.

5. The system of claim 4, further comprising a voice recognition device.

6. The system of claim 4, wherein the at least one control device comprises a mechanical actuator in physical interaction with the at least one surgical instrument.

7. The system of claim 6, further comprising a cabinet that contains the at least one control device and the at least one surgical instrument.

8. The system of claim 4, wherein the at least one control device comprises a digital interface with the at least one surgical instrument.

9. The system of claim 4, wherein the at least one control device comprises an analog interface with the at least one surgical instrument.

10. The system of claim 4, wherein the computer has access to a database of foot gestures and their corresponding gesture specific surgical instrument action.

11. The system of claim 4, wherein the gesture specific instrument action comprises turning a surgical instrument on or off.

12. The system of claim 4, wherein the gesture specific instrument action comprises increasing or decreasing the speed of the surgical instrument.Docket No. URMC574 2304813. The system of claim 4, wherein the gesture specific instrument action comprises increasing or decreasing the power of the surgical instrument.

14. The system of claim 4, further comprising a safety filter configured to differentiate between valid foot gestures and extraneous foot gestures.

15. The system of claim 4, further comprising a feedback device configured to provide feedback to a user of the system for controlling surgical instruments, wherein the feedback device is selected from the group consisting of a haptic device, an optical device, an audible device, a sensory device, a voice prompt device, a computer display device.

16. A method for controlling a surgical instrument comprising the steps of: receiving a foot gesture on a foot control device; processing on a computer the received foot gesture; comparing on the computer the received foot gesture with a known set of foot gestures; and providing with a controller a gesture specific control action to a surgical instrument.

17. The method of claim 16, further comprising the step of safety filtering on the computer the received foot gesture to differentiate between valid foot gestures and extraneous foot gestures.

18. The method of claim 16, wherein the known set of foot gestures is contained in a gesture library.

19. The method of claim 16, wherein the gesture specific control action is selected from the group consisting of turning a surgical instrument on or off, increasing or decreasing the speed of the surgical instrument, increasing or decreasing the power of the surgical instrument.

20. The method of claim 17, wherein the received foot gesture is categorized and processed on the computer to improve the accuracy of identifying a received foot gesture with a known foot gesture.

Images