Patent Application
20180220976
The present invention relates to a method and system for providing guidance for medical procedures. In particular, the present invention relates to method and system for performing fluoroscopic surgical procedures with assistance of a guiding laser beam mapped from a plan line overlaid onto a fluoroscopic preview image and onto a surface of a subject patient to improve procedure efficiencies and accuracies for orthopedic surgeons, as well as reduce radiation exposure of the subject patient.
Generally, fluoroscopy is considered indispensable during contemporary orthopedic surgery. However, there is increasing concern regarding occupational safety in the operating room (OR). Orthopedic surgeons are increasingly using X-ray based fluoroscopic techniques in the operation theatre or in the fluoroscopy room. Procedures such as kyphoplasty, vertebroplasty, deformity correction, pelvic fixation, intramedullary inter-locking nails and computerized tomography (CT) guided biopsies require radiation exposure. Vertebroplasty and kyphoplasty are similar medical spinal procedures in which bone cement is injected through a small hole in the skin percutaneously into a fractured vertebra with the goal of relieving back pain caused by vertebral compression fractures. The general philosophy followed by most healthcare facilities is to minimize radiation dosages such that that all radiation exposures must be justified and that the doses must be kept “as low as reasonably achievable” (ALARA). The overall use of radiation in procedures performed by orthopedic surgeons (e.g., fluoroscopy) is not as much as that used by interventional cardiologists. However, there is increasing concern regarding occupational safety in the operating room (OR). In particular, during a course of a career, an orthopedic surgeon and their OR staff could be exposed to potentially dangerous cumulative levels of radiation. This long term exposure can cause substantial cytogenetic and chromosomal damage, potentially increasing cancer risk. Even relatively small doses of radiation should be considered dangerous over the long-term. Therefore, it is accepted within the industry that annual exposure should be kept to an absolute minimum. Additionally, protective measures, including observance of safe working distance from the radiation source and the routine use of protective garments, have been established.
Another common technique used in orthopedic surgeries is the utilization of Kirschner Wires (K-wires) during a medical procedure. In particular, K-wires are one of the mostly widely used tools in fixing bone fractures in orthopedic surgery. K-wire is also often used during the pre-operative and intro-operative planning, such as aligning the nail direction of the surgery through the single or multiple views of X-ray projective imaging. In a conventional procedure, the surgeon inserts a dedicated K-wire guide wire to confirm position under image intensification multiple times before drilling and tapping. This procedure not only adds to expensive operative time, but also inevitably introduces additional dose to both surgeons and patients.
There is a need for improvements for guiding medical procedures, including fluoroscopic-guided procedures, in particular, to reduce an amount of radiation exposure to patients and care providers during procedures that require assisted imaging and guidance. The present invention is directed toward further solutions to address this need, in addition to having other desirable characteristics. Specifically, an automated laser guidance system is provided to reduce overall fluoroscopic radiation, reduce operation time, and increase operative accuracy. In particular, the present invention provides a system and method for a laser guidance system to be used in connection with intra-operative fluoroscopic imaging during procedures that rely on the assistance of imaging devices.
These and other characteristics of the present invention will be more fully understood by reference to the following detailed description in conjunction with the attached drawings, in which:
An illustrative embodiment of the present invention relates to an imaging system and method of operation for use in conjunction with a fluoroscopic imaging procedure implemented as guidance during a medical procedure. In particular, the present invention relates to an automated planetary laser guidance system with one or more rotary laser-diodes for use in conjunction with a fluoroscopic imager. The laser guidance system provides one or more guiding laser beams directed onto a subject to provide guidance during an operation. The guiding laser beams are automatically positioned and aligned after a user (e.g., a surgeon) makes plan lines through fluoroscopic preview images. As a result, the present invention helps surgeons to complete efficient and accurate pre-operative and intra-operative planning and with less exposure to fluoroscopic radiation during the procedure. Use of the present invention reduces an amount of exposure experienced by the patient and the operating staff because the surgeon can rely on the guiding laser beams for guidance rather than having to utilize a radiation causing imager throughout a duration of a procedure.
Specifically, prior to starting the procedure, surgeons utilize imaging to create one or more plan lines to be directed by the guide laser system onto a subject as guiding laser beams. The surgeon creates the plan lines on a fluoroscopic preview image provided on a software interface. The plan lines created by the surgeon are recorded by the laser guidance system to be used for positioning of the guiding laser beams directed onto the subject during the procedure. The directed guiding laser beams are created by one of a plurality of laser diodes. The laser guidance system positions and rotates the laser diodes to provide the guiding laser beams directed onto the subject body during the intra-operative surgery.
Traditionally, fluoroscopic imaging procedures can be implemented utilizing any combination of imaging systems (e.g., C-arm, Bi-plane fluoroscopic imager, etc.).
The radiation detector 104 is configured to electrically transform the x-ray photons 110 into detectable signals. In particular, in accordance with an example embodiment, the radiation detector 104 is a flat panel detector, which is a thin film transistor (TFT) panel with a scintillation material layer configured to receive energy from visible photons to charge capacitors of pixel cells within the TFT panel. The charges for each of the pixel cells are readout as a voltage data value to the processing and display device 106. The control logic 108 is configured to receive input from the processing and display device 106 and transmit signals to control the x-ray source 102. In particular, the control logic 108 provides signals for operating the x-ray source 102 and when to produce x-ray photons 110. As would be appreciated by one skilled in the art, each of the components within the system 100 can include a combination of devices known in the art configured to perform the imaging tasks discussed herein. For example, an image intensifier is an alternative imaging device that can be utilized in place of the radiation detector 104 system discussed herein without departing from the scope of the present invention.
In accordance with an example embodiment of the present invention, each of the laser-diode arrays 202 can be mechanically positioned with an angular coverage (as depicted in
During operation, each of the diodes in the laser-diode arrays 202 is configured to emit a fan guide laser beam that appears as a guiding laser beam 206 on the body of the subject 112 as emitted from the laser-diode array 20. In accordance with an example embodiment of the present invention, the laser-diode arrays 202 can be independently and programmatically rotated mechanically, electronically, and/or optically. In particular, the diodes in the laser-diode arrays 202 are positioned and rotated to create the guiding laser beam 206 that corresponds to a plan line planned on a fluoroscopic preview image device (e.g., the processing and display device 106). Each of laser-diodes itself can be programmatically rotated such that beam direction can be properly aligned according to the user specification (e.g., on the preview image 212). For example, surgeons prescribe plan lines on x-ray images and according these line direction and x-ray imaging geometry parameters, the target position and orientation of laser diodes can be determined, aligned and/or rotated.
In accordance with an example embodiment of the present invention, the processing and display device 106 is further configured to provide surgeons with a planning tool to create one or more plan lines 206a on a preview image 212 for the generation of the placement of the guiding laser beam 206 on a subject 112. In particular, surgeons can create the one or more plan lines 206a on a fluoroscopic preview image 212 through a software interface provided by the processing and display device 106. For example, the surgeons can draw on the preview image 212 using a computer mouse, a touch screen input, drawing tablet, or other input device known in the art. The fluoroscopic preview image 212 is based on an image created by any radiation detector fluoroscopic imager, such as an image intensifier or a flat panel detector (as depicted in
At step 602 the subject 112 and the x-ray sources 102 are positioned for performing an x-ray. In particular, the subject 112 and the x-ray sources 102 are positioned in an arrangement to capture the desired area of the subject 112 and the angles of that area desired to be visualized via the x-ray.
At step 604 the x-ray source 102 is activated. In particular, the x-ray source 102 is activated in response to receiving a user instruction input into the processing and display device 106 and transmitted to the x-ray source 102 via the control logic 108. Upon activation, the x-ray source 102 generates x-ray photons 110 in a direction of the subject 112. At step 606 the x-ray photons 110 are absorbed as charges at the radiation detector 104 to be electrically converted for display by the processing and display device 106.
At step 608 the plurality of pixel cells of the radiation detector 104 read the charges stored in the capacitors and provide a readout signal to the processing and display device 106. Thereafter, the processing and display device 106 receives the readout and converts the readout signal from the radiation detector device 104 (e.g., flat-panel detector, x-ray receptor devices, etc.) into a raw data format. In particular, the processing and display device 106 receives the readout signal and converts the signal into a format for display utilizing any system or method known in the art. During this period of time the x-ray can be implemented to have either a continuous or pulsed exposure.
At step 610 the system 100 processes the raw data produced by the x-ray and transforms the raw data into a preview image 212 and displayed on a display device 106 (e.g., a monitor) for interpretation and pre-planning by a user. The display being an x-ray image of the subject 112. At step 612 the processing and display device 106 receives one or more plan lines 206a from a user as an overlay on the displayed preview image 212.
At step 614 the processing and display device 106 determines a positioning and rotation for one more diodes within the laser diode array 202 need to direct guiding laser beams 206 at the same location on the subject 112 in the real world as the one or more plan lines 206a created on the preview image 212. At step 616 processing and display device 106 transmits a signal to the laser diode array 202 (via the control logic 108) position and rotate the diodes in the laser diode array 202 according to determined positioning and rotation based on one or more plan lines 206a.
At step 618 the laser diode array 202 directs one or more guiding laser beams 206 from the diodes in the direction of the subject 112. The one or more guiding laser beams 206 create visible light lines on a surface of the subject 112. Additionally, the guiding laser beams 206 correspond to the location and angle of the one or more plan lines 206a created by the user on the preview image 212 as they related to the locations on the subject 112. At step 620 the user (e.g., a surgeon) can being performing a fluoroscopic procedure based on the guiding laser beams 206 displayed on the subject 112. As a result of the process 600, the laser guidance system 200 provides improved surgical precision while significantly reducing dependence on intra-operative fluoroscopy (e.g., reducing exposure to radiation).
Any suitable computing device can be used to implement the computing devices 106, 108 and methods/functionality described herein and be converted to a specific system for performing the operations and features described herein through modification of hardware, software, and firmware, in a manner significantly more than mere execution of software on a generic computing device, as would be appreciated by those of skill in the art. One illustrative example of such a computing device 700 is depicted in
The computing device 700 can include a bus 710 that can be coupled to one or more of the following illustrative components, directly or indirectly: a memory 712, one or more processors 714, one or more presentation components 716, input/output ports 718, input/output components 720, and a power supply 724. One of skill in the art will appreciate that the bus 710 can include one or more busses, such as an address bus, a data bus, or any combination thereof. One of skill in the art additionally will appreciate that, depending on the intended applications and uses of a particular embodiment, multiple of these components can be implemented by a single device. Similarly, in some instances, a single component can be implemented by multiple devices. As such,
The computing device 700 can include or interact with a variety of computer-readable media. For example, computer-readable media can include Random Access Memory (RAM); Read Only Memory (ROM); Electronically Erasable Programmable Read Only Memory (EEPROM); flash memory or other memory technologies; CDROM, digital versatile disks (DVD) or other optical or holographic media; magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices that can be used to encode information and can be accessed by the computing device 700.
The memory 712 can include computer-storage media in the form of volatile and/or nonvolatile memory. The memory 712 may be removable, non-removable, or any combination thereof. Exemplary hardware devices are devices such as hard drives, solid-state memory, optical-disc drives, and the like. The computing device 700 can include one or more processors that read data from components such as the memory 712, the various I/O components 716, etc. Presentation component(s) 716 present data indications to a user or other device. Exemplary presentation components include a display device, speaker, printing component, vibrating component, etc.
The I/O ports 718 can enable the computing device 700 to be logically coupled to other devices, such as I/O components 720. Some of the I/O components 720 can be built into the computing device 700. Examples of such I/O components 720 include a microphone, joystick, recording device, game pad, satellite dish, scanner, printer, wireless device, networking device, and the like.
As utilized herein, the terms “comprises” and “comprising” are intended to be construed as being inclusive, not exclusive. As utilized herein, the terms “exemplary”, “example”, and “illustrative”, are intended to mean “serving as an example, instance, or illustration” and should not be construed as indicating, or not indicating, a preferred or advantageous configuration relative to other configurations. As utilized herein, the terms “about” and “approximately” are intended to cover variations that may existing in the upper and lower limits of the ranges of subjective or objective values, such as variations in properties, parameters, sizes, and dimensions. In one non-limiting example, the terms “about” and “approximately” mean at, or plus 10 percent or less, or minus 10 percent or less. In one non-limiting example, the terms “about” and “approximately” mean sufficiently close to be deemed by one of skill in the art in the relevant field to be included. As utilized herein, the term “substantially” refers to the complete or nearly complete extend or degree of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art. For example, an object that is “substantially” circular would mean that the object is either completely a circle to mathematically determinable limits, or nearly a circle as would be recognized or understood by one of skill in the art. The exact allowable degree of deviation from absolute completeness may in some instances depend on the specific context. However, in general, the nearness of completion will be so as to have the same overall result as if absolute and total completion were achieved or obtained. The use of “substantially” is equally applicable when utilized in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result, as would be appreciated by one of skill in the art.
Numerous modifications and alternative embodiments of the present invention will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present invention. Details of the structure may vary substantially without departing from the spirit of the present invention, and exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention. It is intended that the present invention be limited only to the extent required by the appended claims and the applicable rules of law.
It is also to be understood that the following claims are to cover all generic and specific features of the invention described herein, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.
