Patent Application
20250082178
Rigidizing devices that may rapidly transition between a compliant and flexible configuration and a more rigid configuration may allow access and treatment options that were previously not possible. For example, dynamically rigidizing overtubes and endoscopes have been described and utilized to reduce risks associated with looping and to facilitate medical procedures, including colonoscopy. In the flexible state, such devices may be soft and pliable, but in the rigid state, may become many times stiffer. In some cases, the transition between flexible and rigid states (“Dynamic Rigidization”) may be actuated by the application of positive and/or negative pressure.
Dynamically rigidizing medical devices may include elongate, sometimes tubular structures that include catheters, sheaths, scopes (e.g., endoscopes), wires, overtubes, cannulas, trocars or laparoscopic instruments. The devices can function as a separate add-on device or can be integrated into the body of devices. The devices are inserted into the body so as to access regions within the body, including in some cases forming passages for additional diagnostic and therapeutic medical devices.
When operating dynamically rigidizing apparatuses, and in particular, pressure-actuated (e.g., positive pressure and/or negative pressure, typically either liquid or in gas phase) apparatuses, it may be particularly beneficial to transition quickly between the flexible and rigid states. Although such tools may provide safe, efficient, and precise access to otherwise difficult to reach anatomical locations, it would be beneficial to provide various improvements to rigidizable devices, including improvements that allow the devices to be safer, faster, offer a wider range of flexibility and stiffness, thinner walls, enhance manufacturability, reduced set-up and tear-down time and complexity, reduced environmental impact and landfill, and the ability to function as higher performance combined systems.
Described herein are apparatuses and methods that may address these needs.
Described herein are methods and apparatuses for improving the operation and safety of dynamically rigidizing devices, and in particular, for improving the operation and safety of pressure-actuated dynamically rigidizing devices. For example, described herein are apparatuses (e.g., systems and devices, including sub-systems) and methods for controlling the applied pressure, apparatuses and methods for reducing or eliminating risks of cross-contamination, apparatuses and methods for pressure relief when using a rigidizing apparatus, and apparatuses and methods for routing pressure tubing that may be integrated with a rigidizing apparatus.
For example, described herein are apparatuses, including sub-systems, for regulating and/or controlling the application of fluid pressure, and in particular air pressure, to rigidize or de-rigidize a device. These apparatuses may be referred to for convenience as rigidizing pressure control systems or sub-systems, and may be configured to be used with a rigidizing device and/or may be configured to be integrated with the rigidizing device. Any of the rigidizing pressure control systems/sub-systems described herein may include a pressure source or may be configured to be coupled to a pressure source. For example, the pressure source may include a pump (pressure pump), cannister or reservoir of pressurized fluid (e.g., pressurized air or other gas), or the like. The pressure source may be a stand-alone pressure source or a facility integrated wall pressure source (e.g., centralize air pressure line). The rigidizing pressure control systems/sub-systems described herein may be configured to apply positive pressure. Alternatively, in some cases these rigidizing pressure control systems/sub-systems may be configured to operate with negative pressure (suction). Alternatively, in some cases these pressure control systems may be configured to operate with both positive and negative pressure.
In general the rigidizing pressure control systems/sub-systems described herein may be configured to be normally closed or normally opened. Normally closed rigidizing pressure control systems/sub-systems may provide a pulse of pressure (e.g., a bolus of pressure), typically positive pressure (but also possibly negative pressure) to the rigidizing device. The pulse of pressure may be a pulse of pressurized fluid (in particular, pressurized air). The pulse of pressure may be relatively high pressure (e.g., between 2-40 atmospheres, e.g., between 2 and 40 atmospheres, between 2-15 atmospheres, between 2-10 atmospheres, etc.). It may be full vacuum or partial vacuum. In order to transition the rigidizing device between the flexible and rigid states, the rigidizing device and rigidizing pressure control system/sub-system may be configured to hold the pressure within the rigidizing device in passive operation, e.g., within a bladder/compression layer(s) or region(s). For example, the pressure pathway from the rigidizing pressure control systems/sub-systems to the rigidizing device may be sealed when engaged, to minimize or prevent leakage. The rigidizing pressure control systems/sub-systems may be configured to controllably release, e.g., open or vent, to de-pressurize the rigidizing device and transition between rigid and flexible configurations. In some examples, the rigidizing pressure control systems/sub-systems may also or alternatively be configured to apply negative pressure. In some examples the rigidizing pressure control system/sub-system may be configured to monitor the pressure within the rigidizing pressure control system/sub-system and/or the rigidizing device in order to apply one or more additional pulses of pressure to maintain the rigidity of the rigidizing device with a predetermined range. Any of these apparatuses may include one or more pressure sensors to determine the pressure within the rigidizing pressure control system/sub-system and/or the rigidizing device (e.g., the bladder or compression layer(s)).
A normally open rigidizing pressure control system/sub-system may be configured to apply pressure at a level (which may be adjustable, and may be based on feedback from one or more pressure sensors) to control the state, e.g., to rigidizing and/or de-rigidize the rigidizing device.
Any of the normally closed rigidizing pressure control system/subsystem may include a pressure reservoir (e.g., a tank) for holding the pressurized fluid to be applied. The rigidizing pressure control systems/sub-systems may be referred to as system for rigidizing an elongate rigidizing device and may include: a pressure line configured to couple at a distal end to a pressure inlet of the elongate rigidizing device; a pressure sensor configured to detect pressure within the pressure line; a vent valve proximal to the pressure sensor and in fluid communication with the pressure line; a supply valve proximal to the vent valve and pressure sensor and in fluid communication with the pressure line; a pressure controller proximal to the supply valve and configured to couple to a source of pressurized fluid and to open the supply valve to apply a pulse of pressurized fluid through the pressure line to rigidize the elongate rigidizing device. The pressure line may include tubing or other channels that may pass the pressurized fluid (e.g., air) from the rigidizing pressure control system/sub-system to the rigidizing device, and may include one or more connectors for coupling to the pressure inlet of the rigidizing device. The connectors may be any appropriate connector (e.g., a pressure fitting) in order to securely couple between the pressure inlet and the pressure line of the rigidizing pressure control system/sub-system.
The pressure sensor may be any appropriate pressure sensor, including mechanical (spring-based, deflection/expansion based, etc.) pressure sensors, piezoelectric pressure sensors, capacitive pressure sensors, bourdon tube pressure sensors, etc. The rigidizing pressure control systems/sub-systems may include multiple pressure sensors, including redundant pressure sensors. The pressure sensor may be fluidly connected at any appropriate region of the pathway in fluid communication with the rigidizing device, including in fluid communication with the pressure line, pressure inlet, etc. The pressure sensor(s) may communicate with (input to) the pressure controller.
The rigidizing pressure control systems/sub-systems described herein may generally include one or more valves, including a vent valve (or valves) for releasing/venting pressure to atmosphere from the rigidizing device and/or pressure line. Any appropriate valve may be used, particularly valves that may be controlled by the pressure controller. Examples of pressure valves may include, but are not limited to solenoid valves, motorized valves, etc. Fast (e.g., high-speed) valves may be preferred.
Any of these apparatuses (e.g., rigidizing pressure control systems/sub-systems) may be configured so that the pressure controller is configured to apply the pulse of pressure for 1 second or less (e.g., for 0.9 seconds or less, 0.8 seconds or less, 0.7 seconds or less, 0.6 seconds or less, 0.5 seconds or less, 0.4 seconds or less, etc.). The pulse may be defined by the on time (the time in which the pulse is applied, e.g., 1 second or less) and the pressure applied by the rigidizing pressure control system/sub-system, which may be controlled by the controller and/or a pressure regulator. In general, the pressure applied during the pulse may be between 1.5 atmospheres and 40 atmospheres (e.g., between 2 atmospheres and 15 atmospheres, between 2 atmospheres and 10 atmospheres, between 2.5 atmospheres and 15 atmospheres, between 3 atmospheres and 40 atmospheres, etc.). For example, the pressure controller may be configured to apply the pulse of pressurized fluid at between 2 atmospheres and 10 atmospheres. In any of these examples, the apparatus may be configured to apply a single pulse of pressure (rigidizing pulse) to rigidize the rigidizing device. The use of a single, relatively high-pressure pulse may rapidly (nearly instantaneously) transition the rigidizing device between flexible and rigid configuration. Alternatively, in some examples multiple pulses of pressure (rigidizing pulses) may be applied to transition the rigidizing device between flexible and rigid configurations. Multiple rigidizing pulses may prevent over-rigidizing of the rigidizing device.
In general, the pressure controller may include a control circuitry. The control circuitry may include one or more processors, one or more memories, one or more clocks/timers, etc. The control circuitry may be redundant, including configurations in which both control circuit elements must ‘agree’ for an operation to take place. Similar redundancies and ‘agreements’ may be applied to other parts of the system, including pressure sensors and valve actuations. The control circuitry may be configured to detect a drop in pressure from the one or more pressure sensors below a threshold and may be configured to apply one or more additional pulses of pressure through the pressure line, e.g., to maintain the pressure within a predetermined range. In some examples these maintenance pressure pulses may be shorter and/or different pressures than the initial pulse(s). For example, the one or more additional pulses of pressure may be less than, e.g., 200 ms (e.g., less than 150 ms, less than 100 ms, less than 75 ms, less than 50 ms, less than 30 ms, etc.) long.
In any of these examples the control circuitry may be configured to open the vent valve(s) to de-rigidize the elongate rigidizing device. In some examples the vent valve may be connected to atmosphere (e.g., the surrounding environment). As described in some examples herein, the vent valve location may be controlled to prevent cross-contamination. In some examples the vent valve may open to a source of negative pressure so that the de-pressurization process is more actively driven.
In general, the control circuitry may be configured to determine a leak rate and to trigger an alert if the leak rate exceeds a leak threshold while in the rigid state. For example, if one or more of the pressure sensors detects the pressure falling below a threshold, the apparatus may be configured to trigger an alert (visible, audible, tactile, etc.). This alert may result in the application of one or more additional pulses of pressure to maintain the pressure. Alternatively, in some cases the alert may lead to other states, including the halting of the procedure. Multiple types of alerts may be emitted depending on the speed with which the pressure is falling, e.g., indicating a “slow” leak or a “fast” leak; a slow leak (e.g., less than 0.3 atm/min, 0.2 atm/min, 0.1 atm/min, 0.05 atm/min, 0.01 atm/min, etc.) may result in additional pressure pulses, whereas more rapid leaks (greater than about 0.01 atm/min, greater than 0.05 atm/min, greater than 0.1 atm/min, greater than 0.2 atm/min, greater than 0.3 atm/min, greater than 0.5 atm/min, etc.) may result in stopping the procedure, and depressurizing the apparatus.
As mentioned, any of the rigidizing pressure control systems/sub-systems described herein may include a source of pressurized fluid and/or a pressurized reservoir. The pressurized reservoir may include a tank, chamber, etc. of pressurized fluid that may be used to apply the pulse(s). The pressure controller may be configured to maintain the pressurized reservoir within a pressure level appropriate for the application of the one or more pressure pulses.
Any appropriate pressurized fluid may be used, including gases and liquids. In particular, the pressurized fluid may be a gas, such as air, nitrogen, carbon dioxide, etc.
The supply valve may be maintained closed and may be configured to be opened by the pressure controller. The supply valve may be in fluid communication with the pressure line and proximal to the vent and pressure sensor. In some examples the supply valve may open/close the fluid communication between the source of pressurized fluid (e.g., the pressure source and/or reservoir) and the fluid line.
Any of the rigidizing pressure control systems/sub-systems described herein may be used with one rigidizing device or may be used with multiple rigidizing devices. In some examples multiple rigidizing pressure control systems/sub-systems may be used together, and may be collectively controlled by a system controller that is separate from, and communicates with/commands the pressure controller of each rigidizing pressure control systems/sub-systems. In some examples a single rigidizing pressure control system/sub-system may be configured to control the pressure to multiple rigidizing devices, including nested rigidizing devices. For example, a rigidizing pressure control system/sub-system may independently control the rigidization/de-rigidization of two or more rigidizing devices. For example, any of these systems may include a second pressure line configured to couple to a second elongate rigidizing device, a second pressure sensor in fluid communication with a distal end region of the second pressure line, a second vent valve proximal to the second pressure sensor, and a second supply valve proximal to the second vent valve and in fluid communication with the second pressure line, wherein the pressure controller comprises a pressure manifold and is configured to selectively apply one or more pulses of pressurized fluid through the pressure line or the second pressurized line.
The rigidizing pressure control systems/sub-systems described herein are particularly effective at rapidly applying a pulse of pressure to rigidizing one (or more) rigidizing devices. Although the pulse of pressure may be applied as a relatively high pressure (e.g., up to 10 atmospheres, up to 12 atmospheres, up to 12.5 atmospheres, up to 14 atmospheres, up to 15 atmospheres, up to 17.5 atmospheres, up to 20 atmospheres, up to 22.5 atmospheres, up to 25 atmospheres, up to 27.5 atmospheres, up to 30 atmospheres, etc.) the final pressure achieved in the rigidizing device will be lower, as this pressure is distributed along the length of the bladder/compression layer(s) within the rigidizing device. However, the application of high pressure (potentially higher than the desired baseline resultant pressure) may result in more rapid rigidization.
For example, a system for rigidizing an elongate rigidizing device may include: a pressure line configured to couple at a distal end to a pressure inlet of an elongate rigidizing device, wherein the elongate rigidizing device is configured to be rigidized from a flexible configuration to a rigid configuration; a pressure sensor configured to detect pressure within the pressure line; a vent valve in fluid communication with the pressure line and proximal to the pressure sensor; a supply valve in fluid communication with the pressure line and proximal to the vent and pressure sensor; a pressure controller in communication with the pressure sensor, proximal to the supply valve, and configured to couple to a source of pressurized fluid and to open the supply valve to apply a pulse of pressurized fluid through the pressure line to rigidize the elongate rigidizing device, wherein the pulse of pressure is applied for less than 1 second, and wherein the pulse of pressurized fluid is pressured to between about 2 and 10 atmospheres.
Also described herein are methods of applying one or more pulses of pressure to control rigidization of a rigidizing device, including using any of these apparatuses to control the rigidization and/or de-rigidization of the rigidizing device. For example, described herein are methods of controlling rigidization of an elongate rigidizing device that may include: applying a pulse of pressurized fluid through a pressure line to rigidize the elongate rigidizing device after receiving a command to rigidize the elongate rigidization device, wherein the pulse of pressure is applied for less than 1 second; maintaining the pressure within the rigidizing device by closing one or more valves; and releasing the pressure within the rigidizing device by opening the one or more valves after receiving a command to de-rigidize the elongate rigidizing device. Thus, any of these methods may include coupling a pressure line to an inlet of the elongate rigidizing device.
The pulse of pressurized fluid may be applied by opening a valve (e.g., supply valve) to allow fluid communication between the source of pressurized fluid, which may be a reservoir, and the pressure inlet of the rigidizing device. The quick-opening (e.g., less than 100 ms, less than 75 ms, less than 50 ms, less than 10 ms) valve may remain open for the pulse duration and then close. The resulting bolus of high-pressure fluid may then pressurize the rigidizing device, driving the bladder/compression layer(s) against the rigidizing layer(s) to rigidize the device. In general, as mentioned above, the pressurized fluid may be pressured to 3 atmospheres or more (e.g., 5 atmospheres or more, 6 atmospheres or more, 7 atmospheres or more, 8 atmospheres or more, 10 atmospheres or more, 12 atmospheres or more, 14 atmospheres or more, 15 atmospheres or more, 16 atmospheres or more, 17 atmospheres or more, 18 atmospheres or more, 20 atmospheres or more, 25 atmospheres or more, 30 atmospheres or more, 40 atmospheres or more, etc.), such as between about 2 and 10 atmospheres, etc. In contrast, in the un-rigidized configuration the bladder/compression layer(s) of the rigidizing device may be relatively unpressurised, and may have been vented to atmosphere to de-rigidize. Thus the rapid, relatively large pressure differential may result in a very rapid rigidization.
Once rigidized, following the application of the pulse of pressure, the normally-closed apparatuses described herein may maintain the pressure within the rigidizing device. In some cases the pressure may be maintained through the pressure line and to the inlet valve. Alternatively or additionally, the pressure may be maintained (e.g., by closing one or more valves) from the inlet valve of the rigidizing device. The sealed pathway may maintain the pressure. Any of these methods and apparatuses may also include detecting a drop in pressure within the elongate rigidizing device and applying one or more additional pulses of pressure through the pressure line. For example, the pressure controller may monitor the pressure within the rigidizing device using one or more sensors within the rigidizing device and/or within the pressure line or in fluid communication with the bladder/compression layers(s). Supplemental pulses of pressure may be of the same pressure and duration as the rigidizing pulse(s) or they may be smaller in pressure and/or duration. For example, the one or more additional pulses of pressure may be less than 30 ms long. The supplemental pressure pulses may be the same pressure as the rigidizing pulse(s).
The methods and apparatuses described herein may be configured to adjust the pressure of the pulse of pressure to adjust the time required to rigidize the elongate rigidizing device. For example, higher pressure pulses may result in faster rigidization. In some cases, slower rigidization may be acceptable, and a lower pressure pulse (e.g., between 2-5 atmospheres) may be acceptable; however, in some cases a faster rigidization may be desired, and/or may be selected and therefore a higher pressure pulse (e.g., greater than 4 atmospheres, greater than 5 atmospheres, greater than 6 atmospheres, greater than 7 atmospheres, etc.) may be used.
The duration of the pulse may be relatively fast (e.g., one second or shorter, 900 ms or shorter, 800 ms or shorter, 700 ms or shorter, 600 ms or shorter, 500 ms or shorter, 400 ms or shorter, 300 ms or shorter, 200 ms or shorter, 100 ms or shorter, 20 ms or shorter, etc. In some cases the duration of the pressure pulse may be adjustable. The duration of the pressure pulse may be adjusted based on the total volume of the pressure pathway, e.g., to achieve a final pressure that is sufficiently high to rigidize the rigidizing device.
As mentioned above, the fluid used to apply the pulse of pressure may be any appropriate fluid, including a liquid and in particular may be gas (e.g., air, nitrogen, CO2, etc.). For example, the pulse of pressurized fluid may comprise a pulse of pressurized air.
Also described herein are methods and apparatuses for reducing, minimizing, or eliminating cross-contamination between the rigidizing device and the rigidizing pressure control systems or sub-systems. The rigidizing apparatuses (devices and systems) described herein may be used as part of a sterile procedure (e.g., within a sterile field), so that the rigidizing device may be kept sterile for use within a sterile field, while the rigidizing pressure control system or sub-system is kept clean and is maintained outside of the sterile field. Alternatively, in some examples both the rigidizing device and the rigidizing pressure control systems or sub-systems may be used in a clean, but non-sterile environment. In either case, the apparatus may be configured to prevent cross-contamination from the rigidizing device to the rigidizing pressure control systems or sub-systems. In particular, material (including fluid used to pressurize the apparatus) may be vented or removed distal from the rigidizing pressure control systems or sub-systems to prevent cross-contamination.
For example, described herein are systems for rigidizing an elongate rigidizing device that prevents cross-contamination. The system may include a reusable pressure controller and an interface sub-system. The reusable pressure controller may include: a pressure line; one or more supply valves in fluid communication with the pressure line; and a pressure controller proximal to the supply valve and configured to couple to a source of pressurized fluid and to open the supply valve to apply pressurized fluid through the pressure line to rigidize the elongate rigidizing device. The interface sub-system may include: a handle body integrated with, or configured to couple to, a proximal end of the elongate rigidizing device; a pressure inlet configured to couple to the pressure line; a check valve in fluid communication with a rigidizing pressure inlet of the elongate rigidizing device, wherein the check valve is configured to prevent back flow from the elongate rigidizing device to the pressure outlet; a vent on the handle body; a vent valve connecting the pressure inlet to the check valve and connecting the vent to the rigidizing pressure inlet, wherein the vent valve has at least two states, a first state in which the pressure inlet is fluidly connected to the check valve and the vent is not fluidly connected to the rigidizing pressure inlet, and a second state in which the vent is fluidly connected to the rigidizing pressure inlet and the pressure inlet is not fluidly connected to the check valve, further wherein the vent valve is configured to transition from the second state to the first state when pressure from the pressure inlet exceeds a threshold.
The reusable pressure controller may be referred to herein as a rigidizing pressure control system or sub-system, and may be any of the rigidizing pressure control systems or sub-systems described herein. The interface sub-system may be a rigidizing device or may be configured to couple to a rigidizing device.
In some examples the interface sub-system may include a housing. The housing may be configured to couple to the rigidizing device, including a handle of the rigidizing device. The housing may be configured as a handle body. For example, the interface sub-system may be configured to be integrated into the proximal end of the elongate rigidizing device.
In any of the interface sub-systems described herein the vent valve may be biased in the second configuration. The vent valve may be biased by a spring.
Any of these apparatuses may also include a de-rigidizing valve on the interface sub-system. The de-rigidizing valve may be configured to open to allow venting of pressure from the rigidizing pressure inlet out of the valve.
The pressure controller may receive input from one or more pressure sensors on the interface sub-system. In some examples the pressure controller is configured to apply a pulse of pressurized fluid through the pressure line. As described above, the pressure controller may be configured to apply the pulse of pressure, e.g., for less than 1 second and/or may be configured to apply the pulse of pressurized fluid at between 2 atmospheres and 10 atmospheres.
Also described herein are methods of controlling rigidization of an elongate rigidizing device. For example, a method may include: coupling an interface sub-system to a reusable pressure controller, wherein the reusable pressure controller is separated from the interface sub-system by a pressure line and wherein the interface sub-system is integral with or coupled to a handle portion of the elongate rigidizing device; applying a pulse of positive pressure from the reusable pressure controller to the elongate rigidizing device to rigidize the elongate rigidization device from a flexible state to a rigid state; venting the pressure from the elongate rigidization device to de-rigidize the elongate rigidization device though a vent on the handle, wherein the pressure is vented within the sterile filed. The reusable pressure controller may be outside of a sterile field and the interface sub-system is within the sterile filed.
Also described herein are apparatuses including an external pressure relief or release. An external pressure relief may include a channel or passage for release of pressure from a region around all or a portion of the rigidizing device when the rigidizing device is inserted into the body, e.g., into a colon or other region of the body. The pressure relief may be a separate element, e.g., tube, catheter, etc. or it may be coupled to or integrated into the rigidizing device. For example, the pressure relief may be a part of a sleeve or overtube that engages with the rigidizing member. In some cases the rigidizing member may include an external channel to engage with the pressure relief member (e.g., tube). In some cases the rigidizing device may include an internal channel having lateral exits or access regions that allow fluid communication between the region of the device outside of the rigidizing device and the pressure relief lumen transporting gas away from the region of the lumen around all or a portion of the rigidizing device when the rigidizing device is inserted into the body.
For example, described herein are rigidizing apparatuses configured to provide a relief path for pressure outside of a rigidizing apparatus, the apparatus comprising: a rigidizing device configured to transition between a flexible configuration and a rigid configuration based on an applied pressure; and a pressure relief channel coupled to the rigidizing device, wherein the pressure relief channel is configured to vent pressure from outside of the rigidizing device and out of a pressure relief valve at a proximal end of the pressure relief channel.
In some examples, the pressure relief channel may include an elongate flexible tube. The rigidizing apparatus may include one or more couplers coupling the pressure relief channel to the rigidizing device.
The pressure relief channel may be configured to slide relative to the rigidizing device. Alternatively in some examples the pressure relief channel may be fixed relative to the rigidizing device. The pressure relief channel may include a stop on an outer surface of the pressure relief channel configured to limit axial movement of the pressure relief channel relative to the elongate rigidizing device. In some examples the pressure relief channel comprises a one-way valve preventing passage from the proximal to the distal end of the pressure relief channel.
A distal end region of the pressure relief channel may include one or more (e.g., a plurality of) openings into a central lumen of the pressure relief channel.
The pressure relief channel may be configured to pass through a portion of the elongate rigidizing device.
Also described herein are apparatuses and method for controlling routing a pressure line to a rigidizing device while allowing roll of the rigidizing device. In some examples the pressuring apparatuses may be configured to controllably roll (rotate, e.g., clockwise and counterclockwise) relative to the proximal end of the rigidizing device. In addition to roll, the rigidizing device may also be configured to be steered by bending in one or more degrees of freedom. Roll in particular may be challenging when routing a pressure line to apply positive and/or negative pressure into one or more bladder/compression layer(s) used for rigidizing these apparatuses. Rolling of the rigidizing device relative to the pressure line and rigidizing pressure control system/sub-system may result in added friction, as the pressure line may pull and may also require additional space in the proximal end region to allow for movement. Thus, described herein are tube router devices that may be included as part of a rigidizing device or for use with an apparatus including a rigidizing device. A tubing router device may be configured to control the routing of a pressure line (e.g., tubing) while allowing rotation of the inlet to which the pressure line is fluidly coupled to rotate relative to the tubing router device.
A tubing router (e.g., a tubing router device) may include: a first spool; an input drivetrain member driving rotation of the first spool; an idler drivetrain member rigidly coupled to the first spool and engaging with the input drivetrain member; a second spool configure to rotate with the first spool; an output drivetrain member rigidly coupled to the second spool and driven by the idler drivetrain member; a tubing line configured to wind around and between the first spool and the second spool as the input drivetrain member is driven in a clockwise or a counterclockwise rotation; a fluid input coupled to the first spool and in fluid communication with a lumen of the tubing line; and a fluid output coupled to the second spool and in fluid communication with the lumen of the tubing line.
In any of these devices, the drivetrain member may be a mechanism (e.g., gears, cable, belt, etc.) that could be used to constrain the spools relative to each other. Thus, the input drivetrain member, the idler drivetrain member and the output drivetrain member may be configured to engage with each other to move the first and second spools and to transfer the tube between the two. For example, the idler drivetrain member, the output drivetrain member and the input drivetrain member may be configured as one or more of: a gear train, a friction wheel mechanism, etc. Although the examples described herein may show the use of gears as part of the tubing router device, it should be understood that these devices may use any appropriate mechanism.
For example a tubing router device may include: a first spool; an input gear driving rotation of the first spool; an idler gear rigidly coupled to the first spool and engaging with the input gear; a second spool configure to rotate with the first spool; an output gear coupled (sometimes rigidly) to the second spool and driven by the idler gear; a tubing line configured to wind around and between the first spool and the second spool as the input gear is driven in a clockwise or a counterclockwise rotation; a fluid input coupled to the first spool and in fluid communication with a lumen of the tubing line; and a fluid output coupled to the second spool and in fluid communication with the lumen of the tubing line.
In general, the spools are configured to rotate relative to each other in opposite directions so that a linear tubing line may alternately wind and unwind as the pressure port (e.g., on a rigidizing device that is rigidly coupled to one of the spools) rolls in either the clockwise or anti-clockwise direction. The spools may be adjacent to each other, and/or arranged in parallel. tubing line may be a length of flexible tubing that is fluidly coupled to the first spool (e.g., to the fluid input port on the first spool) and is also fluidly coupled to the second spool (e.g., to the fluid output port) on the second spool. The spools may each be coupled to gears that engage with each other. For example, the first spool may be coupled to an input gear, while the second spool may be coupled to the idler gear. In this configuration the spools may rotate in opposite directions. In some examples a secondary idler gear may be used between the input gear and the idler gear and the first and second spools may rotate in the same direction. In either case, the tubing may be transferred smoothly between the two spools without interrupting the fluid pathway through the tubing connecting the fluid inlet, which may be coupled in fluid communication with the fluid line of a rigidizing pressure control systems or sub-systems, and the fluid outlet, which may be coupled in fluid communication with the pressure inlet of a rigidizing device.
In any of these examples a first end of the tubing line may be coupled to the first spool so that the fluid input is in fluid communication with the lumen of the tubing line. The second end of the tubing line may be coupled to the fluid output through the second spool. The proximal end of the rigidizing device (e.g., overtube, catheter, etc.) may be rigidly coupled to the second spool so that second spool and the rigidizing device may rotate together and may be automatically (e.g. robotically) and/or manually rotated.
Any of these apparatuses may include a limiter limiting rotation of the first spool and the second spool in the clockwise and the counterclockwise directions. The limiter may limit the roll (either or both clockwise and counterclockwise) of the spools and therefore the rigidizing device.
The rotation of the first and second spools may be coordinated by the gearing and radius of the spools so that the rate that the tubing line unspools from one spool matches the rate at which the tubing line spools onto the other spool. In some cases the gearing ratio of the first spool and the second spool is 1:1. For example, the idler gear and the output gear have a gear ratio of 1:1. In some cases the ratio may be different (e.g., between 5:1 and 1:5) but the pitch of the spooling and/or the diameter of the spools may be adjusted so that the rate of spooling and unspooling between the two spools is equivalent, preventing tension on the tubing line and preventing the tubing line from becoming overly loose. For example, the idler gear and the output gear may have a gear ratio of between 3:1 and 1:3. Any appropriate tubing may be used. In some examples the tubing comprises an elastomeric tubing. Any of these apparatuses may be configured to use multiple lines of tubing, e.g., in parallel, concentrically, or in series. For example, two (e.g., parallel) tubing lines (e.g., lengths of tubing) could have increased utility as compared to a single tubing line. In some examples an additional tubing can be utilized by having a secondary line adjacent, such that it spools on or off in tandem. In some examples an additional length of tubing can be concentrically inside of the main tubing line (‘tube in tube’), such that they move in unison, but are attached separately to their respective fluid paths at their ends, such that two fluid paths can be created instead of one, all within one outer tubing profile.
In any of these examples, the fluid input may comprise a connector configured to couple to a source of pressurized fluid. The fluid output may comprise a connector configured to engage with a pressure inlet of an elongate steerable rigidizing device.
As mentioned, in some examples the second spool may be configured to couple with the elongate steerable rigidizing device so that rotation of the second spool results in roll of the elongate steerable rigidizing device while keeping the connector engaged with the pressure inlet.
The tubing router devices (tubing router assemblies) described herein may be used in other apparatuses as well, not limited to rigidizing devices. Any system in which fluid (pressurized or otherwise) must be delivered to a structure that can roll may incorporate as tubing router assembly as described herein. As described herein, a tubing router device may be particularly well suited for use with the rigidizing devices.
For example, a steerable rigidizing system may include: an elongate body; a rigidizing layer within the elongate body; a compression layer configured to be pushed against the rigidizing layer by a pressure differential to rigidize the rigidizing layer; a pressure inlet in fluid communication with the compression layer; and a tubing router comprising: a first spool; an input gear driving rotation of the first spool; an idler gear coupled to the first spool and engaging with the input gear; a second spool configure to rotate with the first spool; an output gear coupled to the second spool and driven by the idler gear; a tubing line configured to wind around and between the first spool and the second spool as the input gear is driven in a clockwise or a counterclockwise rotation; a fluid input coupled to the first spool and in fluid communication with a lumen of the tubing line; and a fluid output coupled to the second spool and in fluid communication with the lumen of the tubing line, wherein the fluid output if also in fluid communication with the pressure inlet, wherein the second spool is coupled with the elongate body so that rotation of the second spool results in roll of the elongate body while keeping the connector engaged with the pressure inlet.
Any of these apparatuses (e.g., systems) may include a proximal handle at a proximal end of the elongate body, wherein the tubing router is within the proximal handle. For example, these apparatuses may include one or more steering tendons configured to steer a distal end region of the elongate flexible body, which may be part of the rigidizing device. These apparatuses may include one or more tendon drivers configured to drive movement of the one or more steering tendons, wherein the one or more tendon drivers are within the proximal handle.
In general, any of the apparatuses and methods described herein may be configured to rigidize and/or de-rigidize one or more dynamically rigidizing devices using a pulse (or in some examples, pulses) of pressurized fluid, which may be referred to equivalently herein as a rigidization medium. The pressurized fluid may water, saline, etc., although the preferred rigidization medium may be a compressible fluid, including a gas, such as, but not limited to, air, carbon dioxide (CO2), nitrogen, etc. In any of these apparatuses and methods, the pulse of pressure may be configured as a high pressure pulse, having a very rapid on and off time, e.g., achieved by operating a fast valve or valves. The pulse of pressure may have a rise time of 100 milliseconds or faster (e.g., 50 milliseconds or faster, 25 milliseconds or faster, 10 milliseconds or faster, 5 milliseconds or faster, 1 millisecond or faster, etc.). In any of these apparatuses and methods, the pulse of pressure (high pressure pulse) applied to rigidize the device may be configured to have a pressure that is greater than the target rigidizing pressure. Thus, the applied pulse of pressure may be overpressurizing as compared to the target rigidizing pressure. For example, a rigidizing device may have a target rigidization pressure of 4 atmospheres (e.g. 4 atm, 5 atm, 6 atm, 7 atm, 8 atm, etc.), and the rigidizing pulse of pressure may be set to be greater than the target rigidization pressure, e.g., 110% or more, 115% or more, 120% or more, 125% or more, 130% or more, 135% or more, 140% or more, 145% or more, 150% or more, 200% or more, 400% or more, etc. of the target rigidization pressure. The use of a rapid on and/or off (e.g., transient), overpressurizing pulse may result in an extremely fast rigidization of the dynamically rigidizing device that is both safe and effective. The speed with which the rigidizing device is rigidized by the transient (e.g. rapid) pulse may depend on how overpressurized the applied pulse is as compared to the target rigidization pressure; in general, the more overpressurized the applied pulse, the faster the rigidization that may be achieved. In general, the target pressure for rigidizing the device may be the optimal (or highest) safe pressure for rigidizing the device, and/or the target pressure for achieving a desired rigidity. In general, once a pulse (e.g., a “transient pulse”) of pressure is applied from the proximal end of the device using an over-pressurized pulse (e.g., greater than the target pressure) the pressure within the device may normalize to a final working (final) pressure that is approximately equal to the target pressure (e.g., within +/−1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, etc. of the target pressure).
The apparatuses and methods described herein may de-rigidizing by rapidly opening one or more venting valves to release the pressure rigidizing the device. Alternatively or additionally, any of the apparatuses described herein may also or alternatively use one or more de-pressurizing pulses, e.g., applying a pulse of negative evacuation pressure, to convert a rigidizing device from the rigid state to a flexible state. For example, a rapid pulse of negative pressure (suction) may be applied to de-rigidize any of these apparatuses. The pulse of negative pressure may have a rapid on time (e.g., 100 milliseconds or faster, 50 milliseconds or faster, 25 milliseconds or faster, 10 milliseconds or faster, 5 milliseconds or faster), and may be, e.g., −0.25 atm or higher vacuum (e.g., −0.5 atm, −0.75 atm, −1 atm, etc.). Thus, in any of these apparatuses and methods the apparatus (e.g., controller) may be configured to apply one or more pulses of negative pressure. The apparatus may be coupled to or may include a source of negative pressure (e.g., pump, tank, etc.).
Any of the apparatuses and methods described herein may be configured to prevent and/or limit leak of the rigidization medium from the rigidizing device or devices. Any of these apparatuses and methods may include one or more (and preferably redundant) sensors that may be used to detect leak(s). These one or more sensors may be configured to sense pressure within the rigidizing device (e.g., in communication with a compression layer or region (e.g., bladder layer or region), within one or more escape or leak pathways (e.g., in communication with a pressure escape pathway), in communication with one or more region outside of the rigidizing device(s) (e.g., to measure intracolonic pressure in variations configured as an endoscope, etc.), and/or in communication with the handle region and/or in communication with the pressure controller (e.g., rigidizing pressure control system/sub-system). The sensors may include pressure sensors and/or flow sensors and may signals from these sensors may be received, processed, stored and/or transmitted by the apparatus, including by the rigidizing pressure control system/sub-system. The apparatus may adjust the application of pressure using this feedback, and/or it may emit one or more alerts to a user to indicate leak (or non-leak).
For example, the apparatus may be configured to detect leak within the rigidizing apparatus when the apparatus is configured to be rigidized by detecting a change in pressure within the compression layer/region over time. One or more (e.g., redundant) pressure sensors may sense pressure in a continuous, and/or periodic manner. Depending on the rate of the change in pressure detected over time, the apparatus may trigger an alert and/or action; for example if the rate of change of the pressure (when not applying a pulse of pressure to the compression layer/region) is greater than a first threshold valve (e.g., the slow leak threshold value) but less than a second threshold value (e.g., a rapid leak threshold value), the system may optionally indicate a fault, and the controller may automatically provide one or more additional (refill) pulses to increase the pressure to the target rigidized pressure. If the detected rate of change in the pressure of the rigidized device is equal to or greater than the second threshold value, the system may include a leak fault and may vent (e.g., de-rigidize) the one or more rigidizing devices. These apparatuses and methods may also track the amount (volume) of fluid leaked over time, based on the rate of leakage (e.g., the rate of pressure change) over time, and the time (e.g., the duration of the leak).
The apparatuses and methods described herein may also determine the location of the leak, for example if the leak is occurring into a region of the body (e.g., colon, esophagus, etc.) around the rigidizing device(s), by including or using one or more sensors that sense pressure and/or flow outside of the rigidizing device(s). For example, any of these apparatuses may include one or more pressure sensors on or in communication with an external region at a distal end region of the rigidizing device(s), e.g., overtube, endoscope, etc., including at the distal tip region, at or in communication with an external region at a medial portion of the rigidizing device(s), and/or at or in communication with an external region at a proximal end of the rigidizing device(s). Measuring changes in the external pressure may allow the system, e.g., the controller, to determine if the leak is occurring into the external region. The sensed pressure may also be used to determine if there is a risk of damage to the surrounding environment. In some examples the external pressure may be monitoring and may provide an indication if the change in pressure is due to a leak in the apparatus (which may be configured by a corresponding pressure detection from within the apparatus). Alternatively, in some examples the apparatus or method may indicate that a change in external pressure is due to insufflation or other additional instrument.
Any of the methods and apparatuses described herein may include one or more pressure escape pathways to prevent a leak from within the device, e.g., a leak from out of the compression layer (also referred to herein as the bladder layer). The pressure escape pathway may generally be outside of the compression layer, and in some cases may pass though or between the rigidizing layer, or between the compression layer and the rigidizing layer. The pressure escape pathway may provide a continuous fluid pathway from the distal end region of the rigidizing device to the proximal end region and may fluidly connect to a pressure outlet or pressure escape port that may be open at or near the proximal end (e.g., in some examples a handle region. Thus, the pressure escape pathway or port may be open and may vent to the proximal region.
For example, described herein are rigidizing devices comprising: an elongate flexible tube; a rigidizing layer comprising an array of filament lengths crossing over and under each other and configured to move relative to each other; an inlet configured to attach to a source of positive pressure; a compression layer configured to be pushed against the rigidizing layer by a pressure differential from the inlet to rigidize the rigidizing layer, wherein the rigidizing device is configured to change between rigid and flexible states by the application of or release of pressure; a pressure escape port at a proximal end region of the elongate flexible tube; and a pressure escape pathway through the rigidizing layer, wherein the pressure escape layer permits a pressurized fluid leaking from the compression layer pass out of the pressure escape port without leaking through the elongate flexible tube. In some examples the pressure escape pathway is between the compression layer and an inner wall of the elongate flexible tube. In some examples the array of filament lengths comprises a plurality of discrete filaments. For example, at least some of the filament lengths of the array of filament lengths may be part of the same filament. The array of filament lengths may comprise a weave, a braid, a knit, chopped filaments, or randomly oriented filaments. The array of filament lengths may comprise one or more wires. Any of these devices may include a reinforced outer layer.
In general, the pressure escape pathway may be adjacent, or in fluid communication with the region immediately adjacent to, the compression layer (e.g., bladder layer). In any of these examples the pressure escape pathway may include a gap layer between the rigidizing layer and the outer or inner layers. The pressure escape pathway may be between the reinforced outer layer and the compression layer.
In any of these rigidizing devices the elongate flexible tube may include a coil-reinforced tube. The inlet may be coupled to a proximal end of the flexible elongate tube. In some examples the inlet is configured to attach to a source of positive pressure, further wherein the compression layer is configured to be pushed against the rigidizing layer when the positive pressure is applied through the inlet. Alternatively, in some examples the inlet may be configured to attach to a source of negative pressure, further wherein the compression layer is configured to be pushed against the rigidizing layer when the negative pressure is applied through the inlet. In this configuration, the escape pathway may prevent suction of fluid (e.g., gas, liquid, etc.) from within the body adjacent to the rigidizing device, and may instead draw air from the proximal end.
In any of these examples the compression layer may comprise a plastic, a plastomer, a composite, or an elastomeric layer. As mentioned, the compression layer may comprise a bladder. The rigidizing device may be configured to have a rigid configuration when positive pressure or negative pressure is applied through the inlet and a flexible configuration when the pressure is not applied through the inlet.
In general the apparatuses and method described herein may be configured to control the rigidity of the rigidizing device based on one or more sensed pressures, including pressure within the elongate rigidizing device (e.g., within the compression/bladder layer), and/or pressure within a region adjacent to the compression region/bladder layer) and/or pressure outside of the elongate rigidizing device (e.g., within a body region in which the elongate rigidizing device has been inserted, such as, but not limited to, the colon, e.g., intracolonic pressure).
For example, described herein are methods of controlling rigidization of an elongate rigidizing device. In some examples the apparatus (e.g., a controller including one or more processors) may be configured to perform any of these methods. For example, the method may include: sensing a decrease in pressure within a compression region of the elongate rigidizing device while the elongate rigidizing device is in a rigid configuration; sensing a pressure external to the elongate rigidizing device; applying one or more pulses of pressurized fluid through a pressure line to increase the pressure within the compression region of the elongate rigidizing device to maintain the rigidity of the elongate rigidizing device if the pressure external to the rigidizing device does not exceed a threshold; and de-rigidizing the compression region of the elongate rigidizing device and triggering an alert if the pressure external to the rigidizing device exceeds the threshold.
In any of these methods an apparatuses sensing the pressure external to the rigidizing device may comprise sensing the pressure through a lumen of the elongate rigidizing device.
In general these method may include clearing an obstruction from the external sensor, e.g., by applying fluid (e.g., air, nitrogen, water, saline, etc.) through the channel used to detect external pressure. In some examples the external pressure is sensed through a lumen within the elongate rigidizing device and any of these methods may include applying a fluid through the lumen to clear any obstruction immediately prior to (or while) sensing the pressure external to the elongate rigidizing device.
Sensing the pressure external to the elongate rigidizing device may include sensing pressure within a body cavity into which the elongate rigidizing device has been inserted. In any of these methods an apparatuses, sensing the pressure external to the elongate rigidizing device comprise sensing intracolonic pressure.
Also described herein are methods and apparatuses for sensing a rate of change of the pressure within the apparatus (e.g., within the compression region, within the fluid supply lines, within a leak path, including but not limited to an escape path, etc.) and controlling the rigidization state, either to add additional pressurized fluid or to de-rigidize the apparatus (e.g., and halt the procedure) and/or trigger an alert and/or alarm. For example, described herein are methods of controlling rigidization of an elongate rigidizing device, the method comprising: identifying a decrease in pressure within a compression region of the elongate rigidizing device while the elongate rigidizing device is in a rigid configuration; applying one or more pulses of pressurized fluid through a pressure line to increase the pressure within the compression region of the elongate rigidizing device to maintain the rigidity of the elongate rigidizing device if the decrease in pressure does not exceed a first threshold; and de-rigidizing the compression region of the elongate rigidizing device and triggering an alert if the decrease in pressure exceeds a second threshold that is greater than the first threshold.
For example, any of these methods may include de-rigidizing the compression region of the elongate rigidizing device and triggering the alert further comprises sensing a pressure external to the elongate rigidizing device and de-rigidizing the compression region when the decrease in pressure exceeds a second threshold that is greater than the first threshold and when the pressure external to the elongate trivial exceeds a leak threshold.
All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.
A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:
The methods and apparatuses (e.g., systems, sub-systems, device, etc.) described herein may improve the operation and safety of dynamically rigidizing devices. For example, described herein are rigidizing pressure control systems or sub-systems. These rigidizing pressure control systems or sub-systems may control the application of pressure to rigidize/de-rigidize a pressure-rigidized device. Also described herein are apparatuses and methods for reducing or eliminating risks of cross-contamination between a rigidizing pressure control systems or sub-systems and a rigidizing device. Also described herein are apparatuses and methods for releasing pressure (e.g., pressure relief) from a region of the body surrounding a rigidizing device when inserted into a body lumen. In addition, described herein are apparatuses and methods for controlling the routing tubing that may be particularly useful with rigidizing devices that roll relative to the source of fluid (including pressurized fluid). Each of these apparatuses and methods are described in greater detail below; these apparatuses and methods may be combined and may be used with one or more rigidizing devices, and in particular pressure-rigidizing devices. In particular, these methods and apparatuses may be used in combination with, and/or may modify and improve the rigidizable devices and methods of using them described in U.S. Pat. No. 11,135,398 (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), U.S. patent application Ser. No. 17/604,203 (also titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), PCT/US2021/024582 (titled “LAYERED WALLS FOR RIGIDIZING DEVICES”), PCT/US2021/034292 (titled “RIGIDIZING DEVICES”), PCT/US2022/014497, (titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES”) PCT/US2022/019711, (titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), U.S. provisional patent application 63/265,934, (titled “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON”), U.S. provisional patent application 63/296,478, (titled “RECONFIGURABLE STRUCTURES”), U.S. provisional patent application 63/308,044, (titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”), U.S. provisional patent application 63/324,011, (“METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES”), U.S. provisional patent application 63/342,618, (titled “EXTERNAL WORKING CHANNELS FOR ENDOSCOPIC DEVICES”), U.S. provisional patent application 63/335,720, (titled “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY”) and U.S. provisional patent application 63/332,686, (titled “MANAGING AND MANIPULATING A LONG LENGTH ROBOTIC ENDOSCOPE”), each of which is herein incorporated by reference in its entirety.
For example, described herein are apparatuses, including sub-systems, for regulating and/or controlling the application of fluid pressure, and in particular air pressure, to rigidize or de-rigidize a device.
In
In general, the apparatuses and methods described herein may be used with a rigidizing device that is controlled by the application of pressurized fluid. The pressurized fluid may cause one or more bladder layers (also referred to herein a compression layers in some examples) against one or more rigidizing layer or layers. This may compress the rigidizing layer, causing it to stiffen. For example,
Another example of a rigidizable device 2100 is shown in
Both examples of a devices shown in
Further, any of the rigidizable devices described herein may be configured as nested apparatuses that may be nested to provide enhanced performance. For example, a nested apparatus (system) is shown in
The inner rigidizing device (e.g., scope 302) can be, for example, configured to receive pressure between the compression layer 321 and the inner layer 335 to provide rigidization. Any of these rigidizing devices, including the inner rigidizing device shown in
The inner lumen 381 of the first, outer rigidizable device 301 can form a gap or interface 381 into which the second, inner, rigidizable device may be positioned. This gap or interface region 381 can have any appropriate dimensions, so that an annular space (d) remains around the second, inner, rigidizable device when inserted into the first, outer, rigidizable device. In some examples, when the inner rigidizable device is centered in the lumen of the outer rigidizable device, space on either side of the inner rigidizable device, d, may be between about 0.001″-0.050″, such as 0.0020″, 0.005″, or 0.020″ wide. The inner surface of the outer rigidizing device and/or the outer surface of the inner rigidizable device may be a low friction surface and may include, for example, powder, coatings (for example, hydrophilic or hydrophobic), or laminations to reduce the friction. In some examples, a seal may be present between the inner device 302 and the outer rigidizable device 301, and the intervening space can be pressurized, for example, with fluid or water, to create a hydrostatic bearing. In other examples, there can be seals between the inner rigidizable device 302 and outer rigidizable device 301, and the intervening space can be filled with small spheres to reduce friction.
The inner rigidizable device 302 and outer rigidizable device 301 can move relative to one another and alternately rigidize so as to transfer a bend or shape down the length of the nested system 300. For example, the inner device 302 can be inserted into a lumen and bent or steered into the desired shape. Pressure can be applied to the inner rigidizing device 302 to cause the rigidizing layer to rigidize the inner rigidizable device 302 in whatever configuration/curve/bend it had when the pressure was applied. The rigidizable device (for instance, in a flexible state) 301 can then be advanced over the rigid inner rigidizable device 302. When the outer rigidizable device 301 is sufficiently advanced relative to the inner rigidizable device 302, pressure (e.g., negative pressure in this example) can be applied to the outer rigidizable device 301 to cause the rigidizing layers to rigidize to fix the shape of the outer rigidizable device. The inner rigidizable device 302 can be transitioned to a flexible state, advanced, and the process repeated. Although the system 300 is described as including an inner rigidizable device configured as a scope, it should be understood that other configurations are possible. For example, the system might include two overtubes, two catheters, or a combination of overtube, catheter, and scope.
Any of the rigidizing devices described herein may therefor include a rigidizing pressure control system or sub-system. In some cases the pressure control system (or sub-system) is configured as a normally closed architecture in order to rigidize the rigidizing device safely and quickly using pressurized fluid. A normally closed configuration may use a discrete amount of pressurized fluid that is held within the rigidizing device in the rigid configuration. Although some leakage may occur, the apparatus is closed, so that leakage may be minimized. This may minimize the inadvertent release of pressurized fluid (e.g., air) into the patient, should a rupture or break occur. This may minimize the amount and the pressure of the fluid released into the patient's body (e.g., into the colon when used for colonoscopy), which may prevent the build-up of pressure within the body that may otherwise harm a patient. Surprisingly, the use of a normally closed system may also enhance the rigidization speed and stiffness.
For example,
In this example, the controller 613 may be configured to (when receiving an automatically or manually determined command to rigidize the rigidizing device 618), may cause a pulse of pressurized fluid to be delivered through the pressure line 614 to the rigidizing device 618. For example, the controller may open the supply valve 615, and then closed it after a short period of time (e.g., approximately 500 ms). For example, in some cases the controller may apply a pulse of pressurized fluid at approximately 4 atmospheres for 500 ms or less (e.g., approximately 300 ms, between 100 ms and 500 ms) to rigidize, and may de-rigidize over between about 800-500 ms. After the pressure has been delivered, the pressure in the rigidizing device may be maintained (typically at a lower pressure than the applied pressure, as the pressurized fluid pulse duration may be faster than the time to equilibrate the pressure within the rigidizing device, and the pressurized fluid is distributed along the length of the device. If the controller, upon receipt of data from the pressure sensor 622, detects a pressure drop in the device below a threshold, the controller may apply another (supplemental) pulse of pressure by opening the supply valve 615 for a short time (e.g., approximately 10 ms) to “top off” the device pressure. To de-rigidize, the controller may cause the vent valve 630 to open in order to vent the pressure in the rigidizing device.
As mentioned above, the normally closed configuration described herein may advantageous because even if a rupture or bursting of the device occurs, there is a limited volume of fluid (e.g., gas) that may enter the patient. In addition, the pressure sensor(s) may monitor the operation of the device and may prevent excessive pressurization and in some cases may detect premature depressurization (e.g., rupture). For example, if the device is losing pressure (e.g., leaking) too quickly, or the device ruptures, the system may indicate that a fault has occurred and may emit an alert. This configuration may also track the volume of gas that is leaked over time, particularly where the volume of the rigidizing device (e.g., the volume within the bladder/compression layer(s)).
In general, these methods may also adjust and/or increase the rate that the rigidizing device rigidizes. As shown in
In
In the example rigidizing pressure control system/sub-system shown in
In the example shown in
The first fluid path 1192 may include one or more (e.g., a pair of redundant) valves 1175 controlling flow through the first fluid path. These valves may be normally closed. The first fluid path 1192 may also include one or more valves controlling venting output 1176. These valves may be normally opened. As mentioned above, using a pair of valves in series (for the normally closed valves) or in parallel (for the normally open valves) may provide added safety and redundancy in the event of failure of one of the valves. Downstream of the valves and between the valves and the pressure interface 1182 is a second one or more pressure (or alternatively flow) sensors, shown as P5 and P6, configured to sense device pressure 1166.
The second fluid path 1193 is parallel to the first fluid path and may be configured similarly, e.g., including one or more (e.g., a pair of redundant) valves 1175′ controlling flow through the second fluid path. These valves may be normally closed. The second fluid path 1193 may also include one or more valves controlling venting output 1176′. These valves may be normally opened. Downstream of the valves and between the valves and the second pressure interface 1183 is a second one or more pressure (or alternatively flow) sensors, shown as P7 and P8, configured to sense device pressure 1168.
The controller 1180 may receive input from each of the sensors and may control operation of the valves and regulator for the rigidizing pressure control system/sub-system 1100. The controller may include hardware, software and/or firmware, including one or more processors, for controlling rigidization of the first and/or second rigidizing device when coupled to the rigidizing pressure control system/sub-system. As used herein, a processor may include hardware that runs the computer program code. Specifically, the term ‘processor’ may be configured as a controller and may encompass not only computers having different architectures such as single/multi-processor architectures and sequential (Von Neumann)/parallel architectures but also specialized circuits such as field-programmable gate arrays (FPGA), application specific circuits (ASIC), signal processing devices and other devices. The controller may receive input from one or more additional sensors, including force sensors or the like. The controller may include control logic for performing any of the methods or procedures described herein.
In any of the apparatuses described herein one or more features may include redundancy by including multiples of various components. Redundant components may help avoid singe-fault failures. For example, redundant valves and/or sensors and or control logic apparatuses may be used so that no single component can cause pressure venting into the patient and the failure would be detected.
Any of these apparatuses may include a vent for de-rigidizing the device on either or both the proximal portion of the rigidizing device (e.g., handle) and/or on the rigidizing pressure control systems or sub-system. In some cases it may be beneficial to include venting for release of pressure on the proximal end of the device (e.g., handle) for mitigation of possible cross-contamination and/or for increasing the speed of de-rigidization. Testing of an apparatus such as that shown in
As described elsewhere herein, any of these apparatuses may also be configured as push-pull regulators, and described in greater detail below, that may provide positive and negative pressure in various configurations to actively and more quickly control rigidizing/de-rigidizing. This may be done by the application of positive and negative pressure, or by just the application of positive pressure, to different sides of the bladder/compression layer within the rigidizing device(s). The controller may control the application of positive pressure and/or negative pressure to either or both the first side of the bladder layer and the second side of the bladder layer.
For example,
Any of these apparatuses and methods described herein, may use push-pull actuation, to rapidly and efficiently transition from the more rigid/less flexible configuration (e.g., from
Any combination of active/passive venting of the rigidizing layer when rigidizing may be used; similarly any combination of active venting and passive venting may be used while de-rigidizing the device may be used. For example,
Any of these methods an applications may be used with just the application of just positive pressure to either or both sides of the bladder layer in a coordinated manner to more accurately and reliable transition quickly between the rigid and flexible configurations. In
As mentioned above, any of these apparatuses may include a relief valve, or may be configured to operate with a relief valve. The relief valve may be integrated into the rigidizing device, or it may be separable or separate from the rigidizing device. In some examples the relief valve is configured as an accessory component that may be used to provide a relief path if pressure in the body lumen (e.g., colon) exceeds a threshold pressure, such as the pressure used for insufflation.
Any of the rigidizing devices described herein may be adapted for use with a relief valve as shown in
Any of the apparatuses described herein may be configured to prevent, reduce or eliminate cross-contamination between the (reusable) rigidizing pressure control systems or sub-systems and the rigidizing device, which may be single-use or limited use (with cleaning or the use of a protective sheath). For example,
Thus, any of these apparatuses may be configured so that the pressurized air from the robotic rigidizing device(s) vents into the room via a port in the rigidizing device and does not vent near (and contaminate) the capital rigidizing pressure control system/sub-system. In the schematic shown, a check valve 1337 may prevent contaminated fluid (e.g., gas) from contacting (and contaminating) the rigidizing pressure control system/sub-system. In some examples, as shown in
For example,
In
In addition to preventing cross-contamination, in some examples venting into the room from the handle region, rather than from the rigidizing pressure control system/sub-system may speed up the rigidizing/de-rigidizing.
In
Thus, any of these apparatuses may include one or more filters between the rigidizing pressure control system/sub-system and the rigidizing device to filter the vented fluid (e.g., air). Any appropriate filter may be used, such as, but not limited to, a 0.2 micron filter, 0.1 micron filter, etc. Thus, a filter on the pressure line may prevent contamination of the rigidization control box 1603, 1603′, as mentioned. In some cases, although the use of a filter may reduce the speed of the rigidization/de-rigidization, due to increased head loss, the apparatuses described herein, including the control circuitry controlling operation of the rigidization, may account for the effects on the filter on the pressure profile.
Any of the apparatuses and methods described herein may include a fluid line routing assembly, referred to herein as a tubing router or tube router assembly.
In contrast, the tube routing assemblies described herein may minimize the friction in the rotary joint and may therefore minimize the rigidizing/de-rigidizing time. These assemblies may also have a relatively small footprint, which may be helpful when integrating them into a handle of the rigidizing device, as shown in
For example,
In the example shown in
As mentioned, any of these apparatuses may be included in the handle portion of a steerable rigidizing device 1848. For example, the tubing router assembly 1850 may be within a housing of the handle region (proximal end region) of the apparatus. In
In general, any of the apparatuses (and methods of using them) described herein may be used with, or as part of, a catheter, an endoscope (including, but not limited to colonoscopes, bronchoscope, colposcope, cystoscope, esophagoscope, gastroscope, laparoscope, thoracoscope, enteroscope, etc.), overtube, etc. These apparatuses and methods may be used with a robotic system, including a robotically controlled endoscope. Robotic systems may advance, withdrawn/retracted, moved back and forth, and/or steered robotically. In some examples, the robotic system may control the operation (e.g., advancing, retracting, and/or actuating) of one or more tools to be used within an external working channel, including any of the tools or tool pairs described herein. Any of the apparatuses described herein may be used with a robotic system, including a robotic endoscope system.
As mentioned above, the rigidizing apparatuses described herein may be configured as part of a robotic system or for use with robotic apparatuses. In some examples the rigidizing device including any of these features may be configured as an outer tubular member that is robotically controlled, e.g., configured as a robotically controlled overtube and/or endoscope assembly.
In the example shown in
The apparatuses and methods described herein may improve the speed and safety of the operation of dynamically rigidizing devices that may transition between rigid and flexible configurations by applying a positive pressure (or in some examples, negative pressure) to rigidize a rigidizing layer of the rigidizing device. The rate at which a rigidizing device that is made rigid by the application of pressure may be enhanced by the application of a pulse of pressure having a relatively high (as compared to the target pressure for rigidizing the device) pressure with a rapid on and off time, e.g., an overpressure pulse. As described above in reference to
In general, the target pressure for the rigidizing device may be more quickly achieved by overpressurizing the applied pulse of pressure. The target pressure may be set (e.g., preset) and/or may be adjusted or adjustable by the user, either continuously or from a selectable list of pressures. For example the system (e.g., the rigidizing pressure control system/sub-system) may include a user input for receiving or selecting the target pressure for one or more rigidizing devices. The amplitude of the pulse of pressure may generally be set to be greater than the target pressure. For example, the pressure of the pulse of pressure may be 105% or greater, 110% or greater, 115% or greater, 120% or greater, 125% or greater, 130% or greater, 135% or greater, 140% or greater, 145% or greater, 150% or greater, 200% or greater, etc. than the target pressure.
Similarly, the duration of the pulse of pressure may be selected and/or adjusted (e.g., automatically by the system) so that the final pressure within the rigidizing device is approximately the target pressure. As the overpressure pulse is applied to the rigidizing device, the bolus of pressurized fluid is distributed though the compression region (defined by the compression layer/bladder layer) to achieve the final pressure within the rigidizing device; this final pressure may approximate the target pressure and is less than the pulse pressure upon equilibration of the pressure within the rigidizing device. The application of the pulse may be completed before the pressure in rigidizing device is equilibrated. In the examples described herein the rigidizing medium, e.g., the fluid being pressurized, is a compressible fluid, such as air or another gas (e.g., carbon dioxide, nitrogen, etc.).
Any of these apparatuses may include one or more sensors for detecting pressure and/or flow within the rigidizing pressure control system/sub-system and/or within the rigidizing device(s). In some examples the sensed data may be used as feedback to control and/or monitor the operation of the applied pressure. For example, the rigidizing pressure control system/sub-system may monitor the applied pressure and/or the ongoing pressure within the system and/or within the rigidizing device. Pressure may be used to detect and/or respond to potential leaks, as will be described in greater detail below, or it may be used to modulate the applied pressure. In some examples the rigidizing pressure control system/sub-system may confirm that the target pressure has been achieved after applying the pulse of rigidizing pressure and/or that the device has been de-rigidized (if applying pressure in the opposite polarity to de-rigidize the device); the control logic may be configured to apply one or more additional pulses, which may be shorter duration, in order to titrate the final pressure within the rigidizing device. In general, these apparatuses may also coordinate the application of pulses of pressure to rigidize/de-rigidize multiple rigidizing devices, including nested devices.
In general, the application of a pulse of overpressurized rigidizing medium (e.g. fluid) may shorten the time to rigidize significantly. Table 1, below, shows examples of measured time for a rigidizing device (e.g., in this example, a rigidizing overtube) that is fully rigidized with a target pressure (e.g., positive pressure) of 4 atmospheres. A variety of overpressurized pulses having a pulse pressure of between 5-8 atmospheres were applied to rigidize the device. As shown in Table 1, the time to fully rigidize (e.g., the time to achieve the 4 atm target pressure) decreased significantly as the pressure of the applied pulse of pressure increased from 5-8 atm. The applied pressure is referred to as the regulator pressure.
The data in Table 1 was measured by sensing pressure at the vent outlet of the rigidizing pressure control system/sub-system and within the rigidizing device. If the pressure of the applied pressure pulse is applied at approximately the target pressure (e.g., 4.06 atm, the time to fully rigidize the rigidizing device is greater than 1 second. The duration of the pulse must be set to be greater than this time in order to allow the rigidizing device to equilibrate to the target pressure. Rigidization may refer to the time to reach the target pressure (e.g., 4 atm for an overtube in this example). Therefore, in the above case, an over pressurization pressure burst (from the baseline case of 4.06) was able to speed the rigidization time by over four-fold (e.g., 4×).
The speed at which the rigidizing devices rigidize may be particularly important when using multiple rigidizing devices, and in particular when using nested rigidizing devices, such as the robotic system as illustrated in
The methods and apparatuses described may also apply pressure to de-rigidize any of these rigidizing devices. For example, in apparatuses that use positive pressure to rigidize, negative pressure may be used to more quickly de-rigidize the apparatus, e.g., reducing the de-rigidization time. In some examples, de-rigidization may be passive, e.g., by opening or venting the rigidizing device (e.g., the compression region) to atmosphere. Passive de-rigidizing time may be, e.g., around 0.9 to 0.7 seconds (e.g., 0.8 seconds). Any of these apparatuses may be considered de-rigidized when the pressure (e.g., when the difference in pressure between the compression region and the room pressure) drops below 0.05 atm. With active de-rigidization a pressure (e.g., negative pressure/vacuum when positive pressure used to rigidize, positive pressure when negative pressure is used to rigidize) may be applied to more quickly de-rigidize the rigidizing device. In general, active de-rigidization, such as the application of a vacuum may result in an increase in the rate of de-rigidization by greater than 20-50% or more across all scenarios tested, for example, this increase in de-rigidization speed was seen even when the apparatus was vented at the handle rather than just at the rigidizing pressure control system/sub-system.
Active de-rigidization may include the application of an evacuation pulse. This evacuation pulse may be applied to the same inlet as the overpressure rigidizing pulse, or to a different inlet. For example, in rigidizing devices that use positive pressure to rigidize, active de-rigidization may include the application of a brief pulse of negative pressure to more rapidly de-rigidize the device. The same rigidizing pressure control system/sub-system may coordinate both the rigidizing pulse and the evacuation pulse. For example, an evacuation pulse (de-rigidizing pulse) of vacuum may be applied to the rigidizing device in the rigid state. The magnitude of the evacuation pulse may be, e.g., between −0.1 atmosphere and −1 atmospheres (e.g., between −0.2 atmospheres and −1 atmospheres, between −0.3 atmospheres and −0.9 atmospheres, etc.). The negative pressure applied during the pulse may be constant or it may vary; for example the peak negative pressure applied may be between −0.1 atmospheres and −2.0 atmospheres, etc. In some examples, the rigidizing pressure control system/sub-system may include or couple to a source of negative pressure for de-rigidizing the device(s), such as a plenum holding a vacuum. A large plenum may be fluidly connected to the rigidizing pressure inlet, and the evacuation pulse could effectively stay at the minimum vacuum pressure (e.g., −0.82 atm) in order to maximize the pressure differential pulling the rigidization medium (e.g., air) out of the device. In some examples a vacuum pump may be used to apply pressure.
The evacuation pulse may have a duration that is set (e.g., preset) or adjustable. In some cases the evacuation pulse may have a duration that is between 0.2 seconds and 0.8 seconds (e.g., between 0.2 seconds and 0.7 seconds, between 0.2 seconds and 0.6 seconds, between 0.2 seconds and 0.5 seconds, etc.). The evacuation pulse duration may be adjusted based on feedback from one or more sensors (e.g., pressure sensors), including one or more pressure sensors in communication with the compression region of the device.
Thus, the apparatuses and methods described herein may apply pulses of pressure either or both to rigidize and to de-rigidize the rigidizing device. In particular, these apparatus and methods may be configured to coordinate the application of one or more pulses of pressure to coordinate operation of a system having multiple rigidizing devices. For example, the apparatus may include a rigidizing pressure control systems or sub-system that is configured to coordinate, e.g., automatically or semi-automatically, the application of pulse of pressure to alternatively rigidize and de-rigidize a nested pair of rigidizing devices.
In
In some cases it may be preferred to include an intermediate dwell period in which both the outer device (e.g., overtube) and the inner device (e.g., endoscope) are both rigid when alternating between rigid/flexibles states of the overtube and endoscope. Thus, the rigidizing pressure control systems or sub-system may control the application of pressure pulses to rigidize and the release of pressure (active or passive) to achieve a desired intermediate dwell time, as shown in
As mentioned above, in any of these apparatuses and methods active evacuation of a rigidized rigidizing device may be used. For example, the rigidizing pressure control systems or sub-system may apply a pulse of negative pressure to de-rigidize a rigid device more quickly. This is illustrated in the state diagram shown in
In general, the rigidizing pressure control systems or sub-system may coordinate the application of rigidizing pressure pulses and the active or passive evacuation of pressure for one or more (including nested) rigidizing devices with a high degree of accuracy. An intermediate dwell period may be a rigidized dwell period, in which both rigidizing devices are simultaneously rigid. The intermediate dwell period may be a flexible dwell period, in which both rigidizing devices are simultaneously flexible. The rigidizing pressure control systems or sub-system may set or adjust the duration of any dwell periods.
As mentioned above, the profiles shown in
The apparatuses described herein may detect and respond to the loss of rigidizing medium and/or may be configured to protect the patient from a loss of rigidizing medium. In general, these apparatuses may include one or more pressure and/or flow sensors, and in particular may include multiple and/or redundant pressure/flow sensors. As described in reference to
In general, any of the apparatuses described herein may include sensors on or withing the rigidizing device, including one or more pressure sensors in fluid communication with the compression region (e.g., bladder), in fluid communication with a region around or adjacent to the compression region, including the escape pathway, and/or in fluid communication with a region outside of the rigidizing device. Sensors may be included at or near the distal end region, one or more regions along the length of the rigidizing device, and/or at a proximal end region of the device. For example, the apparatuses described herein may include a working channel through the device; the working channel may be in fluid communication with the external environment at the distal end region of the device. Thus any of these apparatuses may include one or more sensors (e.g., pressure sensors) in fluid communication with a distal end region of the device that may be controlled (e.g., by the rigidizing pressure control systems or sub-system) to sense pressure outside of the device. The apparatus (e.g., rigidizing device) may be configured to apply a jut of fluid (e.g., saline, air, etc.) through the working channel for a period before sensing the pressure. For example, the apparatus may include a connection (valved connection) to couple a source of fluid to the working channel and the rigidizing pressure control systems or sub-system may control the application of fluid through the working channel in order to verify that the channel is open and/or to clear the channel so that an accurate pressure measurement may be taken. In some examples the apparatus may apply a jet of fluid (e.g., air) periodically, such as every 30 seconds, to verify that the fluid can flow into colon through the working channel. Pressure readings after fluid is applied may therefore accurately reflect the pressure at the distal end region. The flow of fluid (e.g., air, liquid, etc.) may drive out a blocking material and clear the pathway to the outside region. Pressure measurements may be taken periodically (e.g., every 1-5 seconds, every 4-10 seconds, every 10-20 seconds, every 1-30 seconds, etc.) and thus fluid may be driven through the channel periodically, prior to sensing the pressure. For example, if pressure is sensed periodically, fluid may be flushed through the channel periodically to clear the channel and a pressure may be sensed immediately or shortly thereafter (e.g., after waiting 1 second or some other delay time) and/or while applying the fluid. An uncleared blockage may be detected by the system as a high pressure, which may trigger a fault or alert.
In general, any of these apparatuses may include one or more pressure sensors on the outside of the device, including at the device tip. The pressure sensor may be on or in communication with the outside of the device, including in communication with a working channel, as just described, or a washing channel configured to apply fluid to wash or clear the window of an imaging (e.g., camera) sub-system.
Any of these sensors may communicate with the rigidizing pressure control systems or sub-system, which may use the data provided to identify and respond to a leak of rigidizing medium from the rigidizing device. The sensor and/or the control system may include processing, including filtering (e.g., high frequency filtering) for the sensor data.
These methods and apparatuses may therefore determine and monitor the pressure outside of the device, including in some examples the intracolonic pressure. Thus, the system may be configured to determine if the pressure within the outside environment exceeds a threshold, and may further determine if the high pressure is due to a leak from the rigidizing device or from another source, including an insufflation source.
The rigidizing pressure control systems or sub-system may analyze the data (or may transmit to a separate processor for analysis) and may use this data to determine if the device is leaking or holding pressure, and may determine the extent to which a leak is occurring. This information may be transmitted and/or stored, including alerting a user. The determined leak information may also or alternatively be used in one or more control processes to respond to a sensed leak. For example, the system may determine if it should transmit or emit an alert (audible, visual, etc.) based on the magnitude of the leak and in some cases the pressure of the surrounding region (e.g., patient body region). In some examples, if the sensed leak, which may be detected as a loss of pressure within the compression region of the device when the device is in the rigid state, exceeds a first leak threshold (e.g., comparing the change in pressure over time, or rate of change, with the threshold), but is less than a second (higher) leak threshold, and optionally the rigidizing pressure control systems or sub-system confirms that the pressure outside of the device (e.g., intracolonic pressure) does not exceed a threshold, indicating that the leak is not likely to change the external pressure substantially, then the apparatus may optionally emit an alert, may store the event for later review and may apply one or more supplemental pressure pulses (of relatively lower magnitude and brief duration) to maintain the rigidizing pressure within the device.
In some cases if the rigidizing pressure control systems or sub-system determines that the sensed leak exceeds the first leak threshold and is greater than the second (higher) leak threshold, then the system may emit the alert and optionally may shut down the rigidization components of the apparatus, and may vent all of the rigidizing devices. In cases where the sensed pressure outside of the device (e.g., intracolonic pressure) exceed a threshold, the system may shut down the rigidization components of the apparatus, venting the rigidizing devices.
In any of these apparatuses, the pressure sensed (within the device and/or outside of the device) may be monitored, stored and/or may be displayed to the user.
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Furthermore, it should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.
While various embodiments have been described and/or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.
As described herein, the computing devices and systems described and/or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions, such as those contained within the modules described herein. In their most basic configuration, these computing device(s) may each comprise at least one memory device and at least one physical processor.
The term “memory” or “memory device,” as used herein, generally represents any type or form of volatile or non-volatile storage device or medium capable of storing data and/or computer-readable instructions. In one example, a memory device may store, load, and/or maintain one or more of the modules described herein. Examples of memory devices comprise, without limitation, Random Access Memory (RAM), Read Only Memory (ROM), flash memory, Hard Disk Drives (HDDs), Solid-State Drives (SSDs), optical disk drives, caches, variations or combinations of one or more of the same, or any other suitable storage memory.
In addition, the term “processor” or “physical processor,” as used herein, generally refers to any type or form of hardware-implemented processing unit capable of interpreting and/or executing computer-readable instructions. In one example, a physical processor may access and/or modify one or more modules stored in the above-described memory device. Examples of physical processors comprise, without limitation, microprocessors, microcontrollers, Central Processing Units (CPUs), Field-Programmable Gate Arrays (FPGAs) that implement softcore processors, Application-Specific Integrated Circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor.
Although illustrated as separate elements, the method steps described and/or illustrated herein may represent portions of a single application. In addition, in some embodiments one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as the method step.
In addition, one or more of the devices described herein may transform data, physical devices, and/or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules recited herein may transform a processor, volatile memory, non-volatile memory, and/or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and/or otherwise interacting with the computing device.
The term “computer-readable medium,” as used herein, generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media comprise, without limitation, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic-storage media (e.g., hard disk drives, tape drives, and floppy disks), optical-storage media (e.g., Compact Disks (CDs), Digital Video Disks (DVDs), and BLU-RAY disks), electronic-storage media (e.g., solid-state drives and flash media), and other distribution systems.
A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.
The various exemplary methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.
The processor as described herein can be configured to perform one or more steps of any method disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods as disclosed herein.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under”, or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent application claims priority to U.S. Provisional Patent Application No. 63/581,266, titled “PRESSURE RIGIDIZATION APPARATUSES AND METHODS,” filed on Sep. 7, 2023, and herein incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63581266 | Sep 2023 | US |
