ELECTROCAUTERY APPARATUS AND METHOD FEATURING ULTRASOUND GUIDANCE
20220241000 · 2022-08-04
Inventors
Cpc classification
A61B2017/00221
HUMAN NECESSITIES
A61B34/20
HUMAN NECESSITIES
A61B2018/00607
HUMAN NECESSITIES
A61B2034/107
HUMAN NECESSITIES
A61B2018/00898
HUMAN NECESSITIES
A61B2018/00994
HUMAN NECESSITIES
A61B2034/105
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
A61B34/10
HUMAN NECESSITIES
International classification
Abstract
The present invention includes electrocautery devices and methods for surgery. The present invention includes an electrocautery device (or other surgical cutting and dissecting tool; harmonic scalpel; scissors capable of cutting, dissecting and obtaining hemostasis) comprising: (a) a handle portion; (b) an electrocautery unit integrated into said handle portion, and comprising a surgical electrode extending from said distal end thereof; (c) an ultrasonic transponder integrated into said handle portion and extending from said distal end thereof and disposed adjacent to said surgical electrode and so as to be adapted to detect differences in anatomical tissue types distally of said surgical electrode; (d) a source of current to said surgical electrode; (e) a feedback module adapted to either (1) signal the user of the electrocautery device or (2) change or interrupt the current provided by said source of current; and (f) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module. The present invention may be adapted to be used in conjunction with other types of scalpels, scissors, etc.; i.e., cutting and dissecting devices.
Claims
1. An electrocautery device, the device comprising: (a) a handle portion; (b) an electrocautery unit integrated into said handle portion, and comprising a surgical electrode extending from said distal end thereof; (c) an ultrasonic transponder integrated into said handle portion and extending from said distal end thereof and disposed adjacent to said surgical electrode and so as to be adapted to detect differences in anatomical tissue types distally of said surgical electrode; (d) a source of current to said surgical electrode; (e) a feedback module adapted to either (1) signal the user of the electrocautery device or (2) change the current provided by said source of current; and (f) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module.
2. The electrocautery device of claim 1, additionally comprising: (g) an accelerometer and a short-range wireless or wired data transmission module adapted to transmit position and acceleration data from the electrocautery unit, as well as to transmit electrocautery unit status data.
3. The electrocautery device of claim 2, wherein said data transmission module also contains a microprocessor and RAM/ROM memory for managing the short-range wireless or wired interface and converting voltage data from the accelerometer into digitized data.
4. The electrocautery device of claim 1, additionally comprising: (h) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system.
5. The electrocautery device of claim 1, additionally comprising a system that includes a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the electrocautery unit.
6. The electrocautery device of claim 4, additionally comprising: (h) a three-dimensional spatial detection system and associated tactile feedback system contained within the electrocautery device and the associated computer system. Electrocautery Device with Electrocautery Unit, Ultrasonic Transponder and Accelerometer and a Short-Range Wireless or wired Data Transmission Module
7. An electrocautery device, the device comprising: (a) a handle portion; (b) an electrocautery unit integrated into said handle portion, and comprising a surgical electrode extending from said distal end thereof; (c) an ultrasonic transponder integrated into said handle portion and extending from said distal end thereof and disposed adjacent to said surgical electrode and so as to be adapted to detect differences in anatomical tissue types distally of said surgical electrode; (d) a source of current to said surgical electrode; (e) a feedback module adapted to either (1) signal the user of the electrocautery device or (2) change the current provided by said source of current; (f) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module; and (g) an accelerometer and a short-range wireless or wired data transmission module adapted to transmit position and acceleration data from the electrocautery unit, as well as to transmit electrocautery unit status data.
8. The electrocautery device of claim 7, wherein said (f) data transmission module also contains a microprocessor and RAM/ROM memory for managing the short-range wireless or wired interface and converting voltage data from the accelerometer into digitized data.
9. The electrocautery device of claim 7, additionally comprising: (h) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system.
10. The electrocautery device of claim 7, additionally comprising a system that includes (i) a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the electrocautery unit.
11. The electrocautery device of claim 10, additionally comprising: (h) a three-dimensional spatial detection system and associated tactile feedback system contained within the electrocautery device and the associated computer system. Electrocautery System with Electrocautery Unit and Ultrasonic Transponder and Accelerometer and a Short-Range Wireless or Wired Data Transmission Module and Three-Dimensional Spatial Data Module
12. An electrocautery system and device, the system and device comprising: (a) a handle portion; (b) an electrocautery unit integrated into said handle portion, and comprising a surgical electrode extending from said distal end thereof; (c) an ultrasonic transponder integrated into said handle portion and extending from said distal end thereof and disposed adjacent to said surgical electrode and so as to be adapted to detect differences in anatomical tissue types distally of said surgical electrode; (d) a source of current to said surgical electrode; (e) a feedback module adapted to either (1) signal the user of the electrocautery device or (2) change the current provided by said source of current; (f) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module; (g) a computer adapted to accept data from said ultrasonic transponder through said data transmission module and to process said data and signal said feedback module so as to cause said feedback module to either (1) signal the user of the electrocautery device or (2) change the current provided by said source of current; (h) an accelerometer and a short-range wireless or wired data transmission module adapted to transmit position and acceleration data from the electrocautery unit, as well as to transmit electrocautery unit status data; (i) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system; and (j) a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the electrocautery device. Electrocautery System with Electrocautery Unit and Ultrasonic Transponder and Accelerometer and a Short-Range Wireless or Wired Data Transmission Module and Three-Dimensional Spatial Data Module
13. An electrocautery system and device, the system and device comprising: (a) a handle portion; (b) an electrocautery unit integrated into said handle portion, and comprising a surgical electrode extending from said distal end thereof; (c) an ultrasonic transponder integrated into said handle portion and extending from said distal end thereof and disposed adjacent to said surgical electrode and so as to be adapted to detect differences in anatomical tissue types distally of said surgical electrode; (d) a source of current to said surgical electrode; (e) a feedback module adapted to either (1) signal the user of the electrocautery device or (2) change the current provided by said source of current; (f) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module; and (g) a computer adapted to accept data from said ultrasonic transponder through said data transmission module and to process said data and signal said feedback module so as to cause said feedback module to either (1) signal the user of the electrocautery device or (2) change the current provided by said source of current; (h) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system, and (i) a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the electrocautery device. Surgical Cutting Device with Ultrasonic Transponder
14. A surgical cutting device, the device comprising: (a) a handle portion; (b) a surgical cutting blade integrated into said handle portion; (c) an ultrasonic transponder integrated into said handle portion and extending from said proximal end thereof and disposed adjacent to said surgical cutting blade and so as to be adapted to detect differences in anatomical tissue types proximally of said surgical cutting blade; (d) a feedback module adapted to signal the user of the surgical cutting device; and (e) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module.
15. The surgical cutting device of claim 14, additionally comprising: (g) an accelerometer and a short-range wireless data transmission module adapted to transmit position and acceleration data from the surgical cutting device.
16. The surgical cutting device of claim 15, wherein said data transmission module also contains a microprocessor and RAM/ROM memory for managing the short-range wireless interface and converting voltage data from the accelerometer into digitized data.
17. The surgical cutting device of claim 14, additionally comprising: (h) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system.
18. The surgical cutting device of claim 14, additionally comprising a system that includes a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the electrocautery unit.
19. The surgical cutting device of claim 17, additionally comprising: (h) a three-dimensional spatial detection system and associated tactile feedback system contained within the electrocautery device and the associated computer system. Electrocautery Device with Electrocautery Unit, Ultrasonic Transponder and Accelerometer and a Short-Range Wireless Data Transmission Module
20. A surgical cutting device, the device comprising: (a) a handle portion; (b) a surgical cutting blade integrated into said handle portion; (c) an ultrasonic transponder integrated into said handle portion and extending from said proximal end thereof and disposed adjacent to said surgical cutting blade and so as to be adapted to detect differences in anatomical tissue types proximally of said surgical cutting blade; (d) a feedback module adapted to signal the user of the surgical cutting device; (e) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module; and (f) an accelerometer and a short-range wireless data transmission module adapted to transmit position and acceleration data from the surgical cutting device.
21. The surgical cutting device of claim 20, wherein said (f) data transmission module also contains a microprocessor and RAM/ROM memory for managing the short-range wireless interface and converting voltage data from the accelerometer into digitized data.
22. The electrocautery device of claim 20, additionally comprising: (h) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system.
23. The surgical cutting device of claim 20, additionally comprising a system that includes (i) a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the surgical cutting device.
24. The electrocautery device of claim 23, additionally comprising: (h) a three-dimensional spatial detection system and associated tactile feedback system contained within the surgical cutting device and the associated computer system. Electrocautery System with Electrocautery Unit and Ultrasonic Transponder and Accelerometer and a Short-Range Wireless Data Transmission Module and Three-Dimensional Spatial Data Module
25. A surgical cutting system and device, the system and device comprising: (a) a handle portion; (b) a surgical cutting blade integrated into said handle portion, and comprising a surgical cutting blade extending from said distal end thereof; (c) an ultrasonic transponder integrated into said handle portion and extending from said proximal end thereof and disposed adjacent to said surgical cutting blade and so as to be adapted to detect differences in anatomical tissue types proximally of said surgical cutting blade; (d) a feedback module adapted to signal the user of the surgical cutting device; (e) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module; (f) a computer adapted to accept data from said ultrasonic transponder through said data transmission module and to process said data and signal said feedback module so as to cause said feedback module to signal the user of the surgical cutting device; (g) an accelerometer and a short-range wireless data transmission module adapted to transmit position and acceleration data from the surgical cutting device; (h) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system; and (i) a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the surgical cutting device. Electrocautery System with Electrocautery Unit and Ultrasonic Transponder and Accelerometer and a Short-Range Wireless Data Transmission Module and Three-Dimensional Spatial Data Module
26. A surgical cutting system and device, the system and device comprising: (a) a handle portion; (b) a surgical cutting blade integrated into said handle portion; (c) an ultrasonic transponder integrated into said handle portion and extending from said distal end thereof and disposed adjacent to said surgical cutting and so as to be adapted to detect differences in anatomical tissue types proximally of said surgical cutting blade; (d) a feedback module adapted to signal the user of the surgical cutting device; (e) data transmission module for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module; (f) a computer adapted to accept data from said ultrasonic transponder through said data transmission module and to process said data and signal said feedback module so as to cause said feedback module to signal the user of the surgical cutting device; (g) a three-dimensional spatial data module adapted to transmit three-dimensional spatial data to a computer system, and (h) a microprocessor and display adapted to display the surgical site and further incorporate position and acceleration data from the surgical cutting device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0047] In accordance with the foregoing summary, the following provides a detailed description of the preferred embodiments, which are presently considered to be the respective best modes thereof.
[0048] As used herein the distal end refers to the working end or patient end, while the proximal end refers to the operator end or actuator end from which the device of the present invention may be operated. The side opposite the bottom side is referred to as the top side or dorsal aspect. The right side is the side on the right hand when looking from the operator end, end-on. Conversely, the left side is the side on the left hand when looking from the operator end, end-on.
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[0054] The electrocautery attachment 7 may include electrosurgery electrodes and pencils such as those commercially available from Bovie Medical Corporation (commonly referred to as “Bovie tips” regardless of commercial source), or equivalent stainless steel electrodes.
[0055] Examples may include the Resistick II™ line of coated electrodes, including coated blades, balls, or needles made for many different uses, such as those bearing a polytetrafluoroethylene (PTFE) coating.
[0056] The electrocautery attachment 7 may include suction coagulators that can be used with hand or foot control, that may offer suction with or without coagulation at the same time, such as those in diameter sizes of 08, 10, and 12 in French Size.
[0057] The electrocautery attachment 7 may include standard electrocautery pencils that may be controlled with a button, rocker or footswitch. They are also available in models that can be either reused or disposable depending on the needs of the surgeon or facility. Common accessories for these pencils may include a multitude of disposable and reusable electrodes, disposable scratch pads and pencil holsters.
[0058] Two other common alternative electrosurgery attachments are disposable and reusable loops that may be made of tungsten wire with a standard 2.3 mm shaft for use in most electrosurgical pencils.
[0059] The alternative electrocautery attachments may include high temperature, low temperature, and change-a-tip battery operated cauteries.
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[0068] As to the procedure for using the device of the present invention and otherwise to practice its method, the following steps may be used:
[0069] In order to prepare and use the device of the present invention as exemplified by the embodiment shown in
Ultrasound
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[0071] By contrast, an indirect approach may be used whereby the nerve location can be deduced from location of arteries and veins, which are located alongside it in a tightly formed “bundle,” as axillary artery and vein have a distinct size relative to surrounding vessels as well as different anatomical position, either of these parameters may be used for facilitating differentiation.
[0072] The electrocautery device and system of the present invention may in some embodiments incorporate high-resolution ultrasound coupled with a cutting instrument to facilitate real-time detection of target tissue (vessel or nerve), permitting the surgeon to make a judgement during surgery based on tissue detection, and the electrocautery device and system may further be automated such that automatic shut-off occurs when within a certain proximity of target tissue is reached.
[0073] The electrocautery device and system of the present invention may be used in accordance with a stimulus probe to integrate with the electrocautery cutting tool.
[0074] In other embodiments of the present invention, as an alternative to or supplement of the use of high-resolution ultrasound coupled with a cutting instrument to facilitate real-time detection of target tissue (vessel or nerve), such embodiments of the present invention may include the use of a Doppler ultrasound imaging module that may be used to further detect and elucidate blood vessels within proximity of target tissue, including detecting blood flow, blood clots or blocked or narrowed blood vessels.
Neuromonitoring
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[0077] This embodiment of the electrocautery device and system of the present invention may detect muscle activity using needle probes in muscles (electromyography—EMG). Needles may be placed in easily located muscles that are enervated by the neural pathway of interest. Separate stimulus via other needles or movable probe may apply variable charge to area of the nerve. Proximity to the nerve is deduced from how much charge is needed to trigger muscle movement. This may be used for real-time location of nerves.
[0078] This embodiment of the present invention also permits sensory nerve pathways to be monitored directly. Needle probes may be placed at proximal sensory points for direct stimulation, and monitoring needle probes may be placed along known neural pathways for the sensory nerve signal as they ascend to and along the spinal cord. The neural pathway may be monitored for neural activity related to the stimulus, and signals are at a relatively very low level, so averaging over time is used to separate nerve signals from noise.
[0079] This embodiment of the present invention may be used in accordance with known electromyography techniques, as well as those used in common spine surgery to detect proximity to nerve root in the spinal cord area.
[0080] The electrocautery device and system of the present invention may be tuned to identify the long thoracic nerve with needle EMG.
[0081] The electrocautery device and system of the present invention may be tuned to determine basic reliable correlations between stimulus and response, and to determine pathways for monitoring of motor and sensory nerves.
[0082] In some embodiments to the electrocautery device and system of the present invention, the needle EMG signal and the electrocautery device are coordinated in order to permit the system to check for interference and artifacts between instruments, and to attenuate settings to optimize real time, accurate tissue detection, and to provide resultant feedback to the operator to assist in the avoidance of nerve tissue injury.
Biomarkers
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[0084] Biomarker tools are generally in the form of an injectable or lavage suspension of particles that attach to specific tissue in the body. The particles contain a label such as a magnetic or fluorescent compound, which is detected intraoperatively to locate target tissue.
[0085] As an example, nanoparticles with neurotargeting features such as cell surface receptor ligands have been used to label nerves.
[0086] These embodiments of the electrocautery device and system of the present invention may use biomarkers to permit direct imaging of nerve and nerve tissues.
[0087] Biomarker embodiments of the present invention permit the leveraging of axillary vein and artery imaging and identification to target nerve and nerve tissues, such as the long thoracic nerve.
[0088] Biomarker suspension may be administered systemically with intravenous infusion approximately 24 hours prior to surgery. Alternatively, a biomarker suspension may be administered locally with a vascular catheter approximately 2 hours prior to surgery.
[0089] The biomarker signal may be detected with magnetic particle imaging (MPI) or near infrared imaging (NIR), and such techniques may be used for real-time location of nerves and nerve tissues.
[0090] Nerve size and location may be irrelevant with regard to magnetic and fluorescent markers. Typically, vasculature follows nerves for efficient circulatory delivery to nerves. Biomarker sensors are normally sufficiently sensitive and selective to pick up the emitted signals.
[0091] Accordingly, in these embodiments of the electrocautery device and system of the present invention, biomarker detection and associated signaling may be incorporated in order to provide real time, accurate tissue detection, and to provide resultant feedback to the operator to assist in the avoidance of nerve tissue injury.
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[0093] From this schematic, it will be appreciated that the various ultrasound data, neuromonitoring electrical stimulus, and biomarker signals, as well as three-dimensional spatial detection data, may provide visual and tactile feedback to and through the computer system to the electrocautery device in its many embodiments.
[0094] It will be appreciated that the mechanical and electromechanical arrangements in the device, the nature and distribution of the associated software, and the logical order of the steps in the described methods are used for purposes of illustration only, and that the device and the method steps may be varied where not otherwise inconsistent with the purpose and result obtained in the practice of the invention.
[0095] It will be also be appreciated that the mechanical and electromechanical arrangements in the device and the nature and distribution of the associated software within the electrocautery device and system of the present invention may be varied, as may be their individual subassemblies and elements thereof, and the steps of the method may include individual steps and series of steps within subroutines of the methods as described.
[0096] The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. The scope of the invention is thus indicated by the appended claims rather than by the foregoing description of which the claims are to be read as a portion thereof, and all changes that come within the meaning and range of equivalency of the claims are intended to be embraced therein.
[0097] The present invention may be used in accordance with other systems and devices relating to electrocautery surgery or surgery without electrocautery cutting, such as those described in the following references that are hereby incorporated herein by reference:
REFERENCES
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Electrocautery Device with Electrocautery Unit and Ultrasonic Transponder