Sensor film for endoscopic instruments
11617594 · 2023-04-04
Assignee
Inventors
- Robert Brooks (Toronto, CA)
- Justin Wee (Toronto, CA)
- Justin Gerstle (Toronto, CA)
- Thomas Looi (Markham, CA)
- James Drake (Toronto, CA)
Cpc classification
A61B2017/00221
HUMAN NECESSITIES
A61B2017/2908
HUMAN NECESSITIES
A61B2562/22
HUMAN NECESSITIES
A61B2017/2902
HUMAN NECESSITIES
A61B2562/164
HUMAN NECESSITIES
A61B2562/182
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
A61B2562/0219
HUMAN NECESSITIES
International classification
Abstract
An endoscopic instrument for use with a trocar, said endoscopic instrument comprising an elongate shaft body having a proximal end and a distal end; an end effector assembly at said distal end operable by manipulation of actuator mechanism at said proximal end; a substrate core having a first surface and a second surface; at least one sensing element on said first surface, said at least one sensing element located adjacent to said distal end; an electronics module for receiving sensed signals from said at least one sensing element, said electronics module located adjacent to said proximal end; a first conductive layer residing on said first surface, said first conductive layer having first solder mask coated thereon; a second conductive layer residing on said second surface, second conductive layer having a second solder mask coated thereon, and wherein said second conductive layer coupled to said at least one sensing element relays said sensed signals from said at least one sensing element to said electronics module and said a first conductive layer is grounded.
Claims
1. A medical instrument comprising: an elongate shaft body having a proximal end and a distal end; an end effector assembly at said distal end operable by manipulation of an actuator mechanism at said proximal end; at least one substrate core having a first surface and a second surface, and wherein said at least one substrate core is conformally attached to said elongate shaft body; at least one sensing element; an electronics module coupled to said at least one sensing element, said electronics module located adjacent to said proximal end, and wherein said at least one sensing element relays sensed signals to the said electronics module; a first conductive layer residing on said first surface, said first conductive layer having a first solder mask coated thereon; and a second conductive layer residing on said second surface, second conductive layer having a second solder mask coated thereon, and wherein said second conductive layer coupled to said at least one sensing element relays said sensed signals from said at least one sensing element to said electronics module and said the first conductive layer is grounded, wherein said at least one substrate core comprises an upper portion and a lower portion separated by an intermediate conductive layer; and wherein said first conductive layer on said at least one substrate core is a sheet of grounded ferromagnetic metal.
2. The medical instrument of claim 1, wherein said first solder mask is a low friction, non-conductive layer, and wherein said low friction, non-conductive layer is adhered to first conductive layer via an adhesive to surround edges of said substrate core, second conductive layer and second solder mask.
3. The medical instrument of claim 1, wherein said at least one substrate core and said elongate shaft body is flexible.
4. The medical instrument of claim 1, wherein said at least one substrate core is composed of folds and cuts and materials that exceed the effective elastic limit of said elongate shaft body.
5. The medical instrument of claim 4, wherein said materials comprises at least one of hinges, springs, and spiral cut tubes.
6. The medical instrument of claim 1, wherein said at least one sensing element is placed on said elongate shaft body.
7. The medical instrument of claim 6, wherein said at least one sensing element comprises at least one of a radio frequency antenna, force sensor, accelerometer, gyroscope, magnetometers, piezoelectric sensor, ultrasonic sensor, capacitive sensor, Braggs diffraction grating, thermometer, or any array thereof, or a combination thereof.
8. The medical instrument of claim 1, wherein said at least one substrate core and said elongate shaft body is semi-flexible.
9. The medical instrument of claim 1, wherein said at least one sensing element is placed on said end effector assembly.
10. The medical instrument of claim 1, wherein said at least one sensing element is placed on said actuator mechanism.
11. The medical instrument of claim 1, wherein said at least one sensing element is placed on pull rods and/or cables associated with said actuator mechanism.
12. The medical instrument of claim 1, wherein said at least one sensing element is associated with at least one of galvanic sensing, impedance spectroscopy, image sensing, photoplethysmogram (PPG), blood flow, pulse transit time (PTT), ballistocardiogram (BCG), electromyography (EMG), electrocardiography (ECG or EKG), and an electroencephalogram (EEG).
13. The medical instrument of claim 1, wherein said medical instrument jog is used with a trocar.
14. The medical instrument of claim 1, wherein said medical instrument is useable with a port in a body.
15. A medical instrument comprising: an elongate shaft body having a proximal end and a distal end; an end effector assembly at said distal end operable by manipulation of an actuator mechanism at said proximal end; at least one substrate core having a first surface and a second surface, and wherein said at least one substrate core is conformally attached to said elongate shaft body; at least one sensing element; an electronics module coupled to said at least one sensing element, said electronics module located adjacent to said proximal end, and wherein said at least one sensing element relays sensed signals to the said electronics module; a first conductive layer residing on said first surface, said first conductive layer having a first solder mask coated thereon; and a second conductive layer residing on said second surface, second conductive layer having a second solder mask coated thereon, and wherein said second conductive layer coupled to said at least one sensing element relays said sensed signals from said at least one sensing element to said electronics module and said the first conductive layer is grounded; wherein said first conductive layer on said at least one substrate core is a sheet of grounded ferromagnetic metal.
16. The medical instrument of claim 15, wherein said at least one substrate core is composed of folds and cuts and materials that exceed the effective elastic limit of said elongate shaft body.
17. The medical instrument of claim 16, wherein said first solder mask is a low friction, non-conductive layer, and said low friction, non-conductive layer is adhered to said sheet of grounded ferromagnetic metal via an adhesive and around edges of said substrate core, intermediate conductive layer, second conductive layer and second solder mask.
18. The medical instrument of claim 17, wherein said intermediate conductive layer relays said sensed signals and said second conductive layer is a grounded shield.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Several exemplary embodiments of the present invention will now be described, by way of example only, with reference to the appended drawings in which:
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
(11) The detailed description of exemplary embodiments of the invention herein makes reference to the accompanying block diagrams and schematic diagrams, which show the exemplary embodiment by way of illustration. While these exemplary embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, it should be understood that other embodiments may be realized and that logical and mechanical changes may be made without departing from the spirit and scope of the invention. Thus, the detailed description herein is presented for purposes of illustration only and not of limitation. For example, the steps recited in any of the method or process descriptions may be executed in any order and are not limited to the order presented.
(12) Moreover, it should be appreciated that the particular implementations shown and described herein are illustrative of the invention and its best mode and are not intended to otherwise limit the scope of the present invention in any way. Connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system.
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(14) As shown in
(15) In another exemplary implementation, as shown in
(16) In one exemplary implementation, as shown in
(17) In another exemplary implementation, as shown in
(18) In another exemplary implementation, as shown in
(19) In yet another exemplary implementation, the features in the previous exemplary implementations of
(20) As shown in
(21) In one example, sensing elements 24 are implemented as metal or piezoelectric strain gauges in order to measure forces. As such, strain gauges 24 are configured to output a voltage signal based on a change in resistance when surgical instrument 10 to which they are attached to undergoes tension or compression. The one or more strain gauges 24 are mechanically coupled to the structural shaft 42 of the endoscopic instrument 10. The coupling of the strain gauges 24 is preferably accomplished with as thin an adhesive 48 as possible, with a hardness between that of the strain gauge 24 material and the shaft body 42 material. Adhesive 48 may be, but is not limited to, cyanoacrylate, epoxy, or acrylic. Additionally, the one or more strain gauges 24 may be welded to the structural shaft body 42 without or in addition to adhesive using, but not limited to, ultrasonic welding, solvent welding, melting, or some combination thereof. Also, the strain gauge 24 may comprises more than one strain gauge pattern in each gauge. For example, in one exemplary implementation, a second strain gauge pattern is placed perpendicular to the first strain gauge pattern to provide thermal compensation.
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(23) In another exemplary implementation, one or more strain gauges 62 are placed in a plurality of configurations, as shown in
(24) In another exemplary implementation, two strain gauges 63a, 63b are placed parallel to shaft 60 of instrument 10 and equally spaced from each other, as shown in
(25) In situations where direct contact is required with the tissue, the one or more sensing elements 62a, 62b, 62c, 63a, 63b, 64a, 64b, and 64c may be, but are not limited to, being located beside, located through, or integrated into the end effector 66 or on the outside of the thin substrate 23 where the endoscopic instrument 10 may or may not be modified to accommodate the one or more sensing elements 62a, 62b, 62c, 63a, 63b, 64a, 64b, and 64c.
(26) In another exemplary implementation, electrodes are placed on endoscopic instrument shaft 60, integrated in end effector 66, or both. These electrodes can be used for, but are not limited to, impedance spectroscopy, EMG, ECG, EEG, electrical stimulation, or any combination thereof. In one application, a combination of two or more of impedance spectroscopy, EMG, and electrical stimulation can be used to assess and monitor muscle viability.
(27) As shown in
(28) In one exemplary implementation, one or more strain gauges at the distal portion of the endoscopic instrument 10 is augmented by an accelerometer, gyroscope, tilt sensor, or any combination in order to give both position and force information. In another exemplary implementation where an energy storage device is used, any energy storage device that can be manufactured to a small size and high energy density can be used and may include, but is not limited to, silver oxide, lithium, aluminum ion, zinc, thin film, supercapacitors, or any combination thereof.
(29) In another exemplary implementation, one or more temperature sensors in the electronics module are used to compensate for thermal effects on the sensitive analog components. In another exemplary implementation, the electronics can be selected to be able to withstand steam sterilization known as autoclaving by selecting electrical components that are rated to exceed the typical temperature of autoclaving, which is 121° C., such as, but not limited to, automotive rated components and lithium poly-carbon monofluoride batteries and by protecting the components from direct exposure to steam by, but not limiting to, plating, coating, potting, enclosing in a sealed case, or any combination thereof. As an alternative to the previously mentioned implementation where steam sterilization known as autoclaving is used, the battery and/or electronics can be made removable so that the removable parts do not need to be selected to survive autoclaving.
(30) In one exemplary implementation, sensor readings are relayed to the surgeon to provide visual, tactile, or auditory feedback. In an instance where the feedback is visual, the information can be displayed by, but not limited to, overlaying the information on an endoscope monitor, having a separate device to display the information, or having a software application to display the information on an existing device such as, but not limited to, a phone, tablet, laptop, computer, or display monitor.
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(32) Electronics module 88 measures the sensor readings and transmits the data to feedback device 90 where user 80 receives the feedback and can modify their operation of the endoscopic instrument 86 accordingly. In one exemplary implementation, electronics module 88 communicates the feedback data, via radio transmission, to feedback device 90, such as a mobile device comprising, but not limited to, a smartphone, tablet, or laptop. The wireless communication to mobile device 90 allows medical trainees to quickly setup a feedback system and allows them to keep the gather data for later learning and analysis. Alternatively, electronics module 88 communicates the feedback data via a wired or wireless connection to a display monitor 92.
(33) In another exemplary implementation, as shown in
(34) In another exemplary implementation, the sensorized instruments may, but are not required to, operate with other sensorized instruments or sensors. The sensorized instruments or sensors may or may not have different sensors, sensor arrangements, number of sensors, or combination thereof. These sensorized instruments and/or sensors may, or may not, coordinate. Coordination can include, but is not limited to, sharing sensor data, synchronizing time, synchronizing events, requesting device operation changes, requesting data, requesting sensor readings be taken, or any combination thereof. These sensorized devices or sensors can be networked in any way or configuration. Networking can include, but is not limited to, planning instrument operation to not interfere with one another such that coordination between the devices is minimized, coordinating between sensorized instruments or sensors, coordinating with a central hub, or any combination thereof. Accordingly, two endoscopic needle drivers are used with the sensor-film communicates with strain gauges at the tips of the instruments. This configuration allows a complete assessment of the magnitude of the forces experienced in suture tying. These endoscopic needle drivers may, but are required to, have accelerometers and/or gyroscopes in their electronics modules in order to additionally capture the relative motion of suture tying.
(35) In another exemplary implementation, one endoscopic instrument with a sensor-film communicates with an optical system at the tip of the instrument such as, but not limited to, PPG and an endoscope are used. The endoscope and sensorized instrument coordinate by momentarily turning the light of the endoscope off so that the optical system can perform its reading in darkness. This momentary turning off of endoscopic light can be done quickly enough such that the human eye does not notice and this can be done consistently to provide effectively simultaneous continuous reading in darkness and illumination for endoscopic viewing.
(36) In another exemplary implementation, an endoscopic instrument with a sensor-film communicates with an electrically-based sensor and another endoscopic instrument utilizing electrical or radio-frequency energy such as, but not limited to, electrocautery, radio frequency ablation, or electrical stimulation are coordinated such that the electrical sensor is not reading and/or the electronics module is not connected while the electrical or radio-frequency energy tool is in operation. This coordination helps to ensure accurate sensor reading and protects the electronics module from damage.
(37) In another exemplary implementation, PPG or BCG is used as the sensor and is integrated with the end effector. Most importantly, this allows the surgeon to assess local blood oxygenation during surgery in addition to other metrics. This system can, but does not have to, be combined with another PPG, BCG, or ECG equipped endoscopic instrument or external PPG, BCG, ECG, or other heart monitor to be used as part of PTT in order to assess blood pressure during surgery and/or in real time.
(38) In another exemplary implementation, up to four strain gauges are placed at the distal portion of the endoscopic instrument at different points and direction such that they can capture all forces and torques experienced by the tip of the instrument which consists of two bending moments, torque, and compression or extension. The mechanical coupling to the endoscopic instrument is accomplished by epoxy. These strain gauges are then attached to a polyimide substrate with gold-plated copper electrical traces by conductive adhesive. The thin substrate finally attaches to an electronics module which comprises an analog front end, temperature sensor, Bluetooth transceiver, and battery. This allows the surgeon to see all of the forces experienced at the tip of the endoscopic instrument and record his motions in unison without any wires inhibiting the procedure. The readings from the temperature sensor are used to temperature compensate the readings from the analog front end for additional accuracy. This exemplary implementation makes no modification of the original endoscopic instrument and is completely wireless during surgery.
(39) In another exemplary implementation in which the instrument undergoes steam sterilization known as autoclaving, the battery is a lithium poly-carbonmonofluoride battery, the components are all rated to above 121° C., the electronics module is a sealed case, and the electronics components are conformably coated, gold plated, and/or sealed. This allows the instrument to be sterilized without disassembling the device and prevents humidity-related inaccuracy and degradation of the analog front end but still allows access to the electronics for calibration and easy battery replacement.
(40) In another exemplary implementation in which the endoscopic instrument has an end effector that requires one or more mechanical actuation rods or cables, additional strain gauges may be placed on the exposed proximal section of the pull rods or cables. The one or more additional strain gauges can be used to capture actuation forces as well as differentiate pull rod or cable forces from compression/extension caused by external forces.
(41) While these exemplary implementations are described in sufficient detail to enable those skilled in the art to practice the invention, it should be understood that other exemplary implementations may be realized and that logical and mechanical changes may be made without departing from the spirit and scope of the invention. The preceding detailed description is presented for purposes of illustration only and not of limitation, and the scope of the invention is defined by the preceding description, and with respect to the attached claims.