Patent Application
20240207570
The present application relates to neurovascular procedures, and more particularly, to catheter assemblies and robotic control systems for neurovascular site access.
A variety of neurovascular procedures can be accomplished via a transvascular access, including thrombectomy, diagnostic angiography, embolic coil deployment and stent placement. However, the delivery of neurovascular care is limited or delayed by a variety of challenges. For example, there are not enough trained interventionalists and centers to meet the current demand for neurointerventions. Neurointerventions are difficult, with complex set up requirements and demands on the surgeon's dexterity. With two hands, the surgeon must exert precise control over 3-4 coaxial catheters plus manage the fluoroscopy system and patient position. Long, tortuous anatomy, requires delicate, precise maneuvers. Inadvertent catheter motion can occur due to energy storage and release caused by frictional interplay between coaxial shafts and the patient's vasculature. Supra-aortic access necessary to reach the neurovascular is challenging to achieve, especially Type III arches. For example, during current neurothrombectomy procedures physicians must remove the guidewire from the catheter to perform dye injections. Many dye injections are needed to navigate through the complex vasculature up to the brain, so guidewires must be removed over 10 times a procedure. The extra step of removing the guidewire increases the duration of the procedure increasing costs time and induces risk of introducing an air bubble to the patient. Even once supra-aortic access is achieved, adapting the system for neurovascular treatments remains time consuming, and requires guidewire and access catheter removal and addition of a procedure catheter (and possibly one or more additional catheters) to the stack.
Thus, there remains a need for a supra-aortic access and neurovascular site access system that addresses some or all these challenges and increases the availability of neurovascular procedures. Preferably, the system is additionally capable of driving devices further distally through the supra-aortic access to accomplish procedures in the intracranial vessels.
There is provided in accordance with one aspect of the present disclosure a supra-aortic access robotic control system. The supra-aortic robotic control system may deliver a fluid to a target site of a patient's vasculature. The system may include a catheter comprising a tubular shaft, a lumen extending longitudinally through the shaft, proximal and distal ends, and a guiding element, which is often a guidewire, but it can be another elongated medical device including but not limited to a catheter. The guiding element and the catheter are sized such that the guiding element can be positioned in the lumen of the catheter. For case of reference in describing aspects of providing fluid through the lumen of the catheter to a target site while a guiding element is positioned inside the lumen, the “guiding element” is often referred to herein simply as a “guidewire” and in many uses the guiding element is a guidewire. Accordingly, unless context of the description indicates otherwise, a reference to a “guidewire” or a “guiding element” can be referring to a guidewire, a catheter, or another elongated medical device. The guidewire may be configured to remain inside the lumen of the catheter creating a space with an annular cross-section, and the guidewire may be navigated to the target site within a vasculature of a patient by the user, such that the distal end of the catheter is also advanced to the target site. A guiding element can include surfaces having different properties, for example, a hydrophilic coating on its distal end and a hydrophobic coating on its proximal end. In an example, the hydrophobic coating is polytetrafluoroethylene (PTFE) or comprises a PTFE-based composition. The system may also include a pump, syringe or injector configured to deliver the fluid through the proximal end of the catheter at a pressure to achieve a desired flow rate such that the fluid is propelled through the annular lumen and out of the distal end at the target site. In some embodiments, the lumen of the catheter communicating fluid may have an inside diameter (ID) of at least about 0.045″. For example, the ID may be between about 0.045″ and about 0.048″. The catheter and the guidewire are configured to allow sufficient fluid to flow through the lumen even when the guidewire is positioned all of partially in the lumen, which reduces an effective cross-sectional area of the lumen. “Effective cross-sectional area” refers to a cross-sectional area of a catheter lumen that is available to communicate fluid. In an example, an effective cross-sectional area of a catheter lumen can be determined by subtracting a cross-sectional area of a guiding element in the lumen from the cross-sectional area of the lumen. In some embodiments, the catheter and the guidewire are structured such that the lumen has an effective cross-sectional area greater than about 0.001257 square inches (when the guidewire is positioned in the lumen). In some embodiments, the catheter and the guidewire are structured such that the lumen has an effective cross-sectional area greater than about 0.001407 square inches (i.e., when the guidewire is positioned in the lumen). In some embodiments, the fluid may be a contrast media. In some embodiments, the guidewire may have a diameter of 0.014 inches, 0.018 inches, or between 0.014 inches and 0.018 inches. In some embodiments, the guidewire may have a diameter of 0.018 inches, 0.020 inches, or between 0.018 inches and 0.020 inches. In some embodiments, the guidewire may have a diameter of 0.024 inches, or between 0.020 inches and 0.024 inches. It is to be understood that although some of the embodiments disclosed herein are described as comprising a guidewire, any suitable guiding element (for example, a guidewire, a catheter, etc.) that is able to aid in navigating a catheter through human anatomy may also be used, where the cross-sectional shape (e.g., circular) and size (e.g., diameter) of the guiding element relative to the cross-sectional shape and size of the lumen of the catheter, when the guiding element is positioned in the lumen, provides a space in the lumen sufficient for the flow of a liquid at a desired flow rate. The desired flow rate of the fluid can be provided for a predetermined amount of time to provides a desired amount of fluid. The desired flow rate can be a predetermined rate. For example, such that a sufficient space in the lumen of a catheter exists for a contrast media to flow at a certain volume when under a certain amount of pressure (e.g., less than or equal to about 400 psi) through the lumen of the catheter and out the distal end of the catheter even when the guiding element positioned in the lumen. Accordingly, the term guidewire and guiding element may be used interchangeably unless the context and/or the specific use of the term indicates otherwise. In some embodiments, the distal end of the catheter may be heat shaped. In some embodiments, the distal end of the catheter may comprise a hypotube. In some embodiments, the hypotube may be laser cut. In some embodiments, the catheter wall may include a braided reinforcement layer of stainless steel wire surrounding part or all of the lumen. In some embodiments, the guidewire may have a hydrophilic coating.
There is further provided in accordance with another aspect of the present disclosure a method for delivering a fluid to a target site of a patient's vasculature, comprising navigating a guidewire to the target site, navigating an lumen of a catheter over the guidewire until a distal end of the catheter is positioned at the target site, coupling a proximal end of the catheter to a fluid pump or injector, and pumping the fluid through proximal end of the catheter, along the annular lumen, and out of the distal end to the target site. In some embodiments, the lumen may have an inside diameter of at least 0.046 inches. In some embodiments, the lumen may have an effective cross-sectional area greater than 0.001257 square inches. In some embodiments, the fluid may be a contrast media. In some embodiments, the guidewire may have a diameter of 0.018 inches, 0.020 inches, or between 0.018 inches and 0.020 inches. In some embodiments, the guidewire may have a diameter of 0.024 inches, or between 0.020 inches and 0.024 inches. In some embodiments, the guidewire may have a diameter of 0.014 inches, 0.018 inches, or between 0.014 inches and 0.018 inches. In some embodiments, the distal end may be heat shaped. In some embodiments, the distal end may comprise a hypotube. In some embodiments, the hypotube may be laser cut. In some embodiments, the lumen may further comprise a braided reinforcement layer of stainless steel wire. In some embodiments, the guidewire may have a hydrophilic coating.
Another innovation includes a system for delivering a fluid to a target site of a patient's vasculature, the system comprising a catheter including a tubular catheter shaft having a proximal end, a distal end, and a lumen defined by an interior surface of the catheter shaft extending longitudinally through the catheter shaft between the proximal end and the distal end; a guiding element having a distal end, a proximal end, and an exterior surface, the guiding element configured to be positioned in the lumen creating an area, between the exterior surface of the guiding element and the interior surface of the catheter, having an effective cross-sectional area greater than or equal to about 0.001257 square inches for fluid communication, the system configured to move the catheter and guiding element such that the distal ends of the guiding element and the catheter advance towards the target site while the guiding element is at least partially in the lumen of the catheter; and a contrast pump coupled to the catheter in fluid communication with the lumen, the system configured to actuate the contrast pump to provide contrast media into the proximal end of the catheter at a pump pressure of less than or equal to about 400 psi while the guiding element is positioned at least partially in the lumen of the catheter such that the provided contrast media propagates through the lumen of the catheter along the exterior surface of the guiding element and flows out of the distal end of the catheter, wherein the effective cross-sectional area allows a predetermined flow rate of the contrast media out of the distal end of the catheter. In some examples, the fluid is a some fluid other than contrast media. In some embodiments, the predetermined flow rate is 3 cc's per second, or about 3 cc's per second. In some embodiments, the predetermined flow rate is at least 3 cc's per second. In some embodiments, the effective cross-sectional area (in the lumen when the guiding element is positioned at least partially in the catheter) can be annular shaped or eccentrically annular shaped. In some embodiments, the effective cross-sectional area can be greater than or equal to about 0.001257 square inches which provides a channel in the lumen to communicate the fluid (e.g., contrast media) through the catheter and out of the distal end of the catheter at the desired rate of flow. In some embodiments, the effective cross-sectional area can be greater than or equal to about 0.001407 square inches which provides a channel in the lumen to communicate fluid (e.g., contrast media) through the catheter and out of the distal end of the catheter at the desired rate of flow. In an example, the desired flow rate is at least about 2 cc's per second. In another example, the desired flow rate is at least about 3 cc's per second. The guiding element can be, for example, a guidewire, a catheter, or another elongated medical device. In some examples, the guiding element has a diameter of about 0.014 inches or about 0.020 inches. In some examples, the guiding element has a diameter of between about 0.014 inches and about 0.020 inches. In some examples, the diameter of the lumen of the catheter (i.e., the inside diameter of the catheter) is about 0.045 inches or about 0.049 inches, or the diameter of the lumen of the catheter is between about 0.045 inches and about 0.049 inches. In some examples, the distal end of the catheter is heat shaped. In some examples, the distal end of the catheter comprises a hypotube, and the hypotube can be a laser cut hypotube. In some examples, the catheter comprises a braided reinforcement layer of stainless steel wire around at least part of the lumen. In some embodiments of a system with multiple catheters, the catheter is a first catheter and the system further comprises a second catheter and a third catheter positioned such that the guiding element, the first catheter, the second catheter and the third catheter are arranged concentrically such that at least a portion of the guiding element, first catheter, and the second catheter are inside the third catheter when providing the contrast media through the lumen of the first catheter. In some embodiments, the guiding element comprises a hydrophilic coating.
Another innovation includes a method for delivering a fluid to a target site of a patient's vasculature using a robotic catheter system, the method comprising moving a distal end of a guiding element towards the target site; moving a distal end of a catheter to the target site while at least a portion of the guiding element is positioned in a lumen of the catheter; and providing contrast media into a proximal end of the catheter while at least a portion of the guiding element is positioned in the lumen of the catheter such that the provided contrast media propagates through the lumen along an exterior surface of the guiding element and out of the distal end of the catheter, wherein the lumen and the guiding element are dimensioned to create an area, between an exterior surface of the guiding element and an interior surface of the catheter, that provides a predetermined flow rate of the contrast media out of the distal end of the catheter at a pump pressure of less than or equal to 400 psi. The flow rate of the fluid is affected by the pump pressure and the effective cross-sectional area. Accordingly, with a pump pressure of less than or equal to 400 psi, the effective cross-sectional area is sized such that the flow rate is, or about, 3 cc's per second. In some embodiments, the effective cross-sectional area is sized such that the predetermined flow rate is at least about 3 cc's per second. In an example, the desired flow rate is at least about 2 cc's per second. In some embodiments, the is annular shaped, or the effective cross-sectional area is eccentrically annular shaped. In some embodiments, the effective cross-sectional area is greater than, or equal to, 0.001257 square inches, or the effective cross-sectional area is greater than, or equal to, about 0.001257 square inches. In some embodiments, the effective cross-sectional area is greater than, or equal to, 0.001407 square inches, or the effective cross-sectional area is greater than, or equal to, about 0.001407 square inches. In some examples, the guiding element has a diameter of about 0.014 inches or about 0.020 inches, or the guiding element has a diameter of between about 0.014 inches and 0.about 0.020 inches. In some examples, the diameter of the lumen (an inner diameter) of the catheter is about 0.045 inches or about 0.049 inches, or the diameter of the lumen (an inner diameter) of the catheter is between about 0.045 inches and about 0.049 inches. In some embodiments, the distal end of the catheter is heat shaped. The method can further comprise providing the contrast media while moving at least one of the guiding element or the catheter towards the target site. In some embodiments, the catheter is a first catheter and a second catheter and a third catheter positioned such that the guiding element, the first catheter, the second catheter and the third catheter are arranged concentrically such that at least a portion of the guiding element, first catheter, and the second catheter are inside the third catheter when providing the contrast media through the lumen of the first catheter. In some embodiments, the guiding element is coupled to a first hub and the catheter is coupled to a second hub, the first hub magnetically coupled to a first carriage of drive assembly through a sterile barrier, the second hub is magnetically coupled to a second carriage of the drive assembly through the sterile barrier, and wherein moving the distal end of the guiding element and the distal end of the catheter comprises moving the first carriage and moving the second carriage.
In certain embodiments, a system is provided for advancing a guide catheter from a femoral artery or radial artery access into the ostium of one of the great vessels at the top of the aortic arch, thereby achieving supra-aortic access. A surgeon can then take over and advance interventional devices into the cerebral vasculature via the robotically placed guide catheter.
In some implementations, the system may additionally be configured to robotically gain intra-cranial vascular access and to perform an aspiration thrombectomy or other neuro vascular procedure.
A drive table can be positioned over or alongside the patient, and configured to axially advance, retract, and in some cases rotate and/or laterally deflect two or three or more different (e.g., concentrically or side by side oriented) intravascular devices. The hub is moveable along a path along the surface of the drive table to advance or retract the interventional device as desired. Each hub may also contain mechanisms to rotate or deflect the device as desired and is connected to fluid delivery tubes (not shown) of the type conventionally attached to a catheter hub. Each hub can be in electrical communication with an electronic control system, either via hard wired connection, RF wireless connection or a combination of both.
Each hub is independently movable across the surface of a sterile field barrier membrane carried by the drive table. In some embodiments, each hub is releasably magnetically coupled to a unique drive carriage on the table side of the sterile field barrier. The drive system independently moves each hub in a proximal or distal direction across the surface of the barrier, to move the corresponding interventional device proximally or distally within the patient's vasculature.
The carriages on the drive table, which magnetically couple with the hubs to provide linear motion actuation, are universal. Functionality of the catheters/guidewire are provided based on what is contained in the hub and the shaft designs. This allows flexibility to configure the system to do a wide range of procedures using a wide variety of interventional devices on the same drive table. Additionally, the interventional devices and methods disclosed herein can be readily adapted for use with any of a wide variety of other drive systems (e.g., any of a wide variety of robotic surgery drive systems).
The drive system 18 may include a support table 20 for supporting, for example, a guidewire hub 26, an access catheter hub 28 and a guide catheter hub 30. In the present context, the term ‘access’ catheter can be any catheter having a lumen with at least one distally facing or laterally facing distal opening, which may be utilized to aspirate thrombus, provide access for an additional device to be advanced therethrough or therealong, or to inject saline or contrast media or therapeutic agents.
More or fewer interventional device hubs may be provided depending upon the desired clinical procedure. For example, in certain embodiments, a diagnostic angiogram procedure may be performed using only a guidewire hub 26 and an access catheter hub 28 for driving a guidewire and an access catheter (in the form of a diagnostic angiographic catheter), respectively. Multiple interventional devices 22 extend between the support table 20 and (in the illustrated example) a femoral access point 24 on the patient 14. Depending upon the desired procedure, access may be achieved by percutaneous or cut down access to any of a variety of arteries or veins, such as the femoral artery or radial artery. Although disclosed herein primarily in the context of neuro vascular access and procedures, the robotic drive system and associated interventional devices can readily be configured for use in a wide variety of additional medical interventions, in the peripheral and coronary arterial and venous vasculature, gastrointestinal system, lymphatic system, cerebral spinal fluid lumens or spaces (such as the spinal canal, ventricles, and subarachnoid space), pulmonary airways, treatment sites reached via trans ureteral or urethral or fallopian tube navigation, or other hollow organs or structures in the body (for example, in intra-cardiac or structural heart applications, such as valve repair or replacement, or in any endoluminal procedures).
A display 23 such as for viewing fluoroscopic images, catheter data (e.g., fiber Bragg grating fiber optics sensor data or other force or shape sensing data) or other patient data may be carried by the support table 20 and or patient support 12. Alternatively, the physician input/output interface including display 23 may be remote from the patient, such as behind radiation shielding, in a different room from the patient, or in a different facility than the patient.
In the illustrated example, a guidewire hub 26 is carried by the support table 20 and is moveable along the table to advance a guidewire into and out of the patient 14. An access catheter hub 28 is also carried by the support table 20 and is movable along the table to advance the access catheter into and out of the patient 14. The access catheter hub may also be configured to rotate the access catheter in response to manipulation of a rotation control and may also be configured to laterally deflect a deflectable portion of the access catheter, in response to manipulation of a deflection control.
Referring to
Alternatively, a proximal segment of one or more of the device shafts may be configured with enhanced stiffness to reduce buckling under compression. For example, a proximal reinforced segment may extend distally from the hub through a distance of at least about 5 centimeters or 10 centimeters but typically no more than about 120 centimeters or 100 centimeters to support the device between the hub and the access point 24 on the patient. Reinforcement may be accomplished by using metal or polymer tubing or embedding at least one or two or more axially extending elements into the wall of the device shafts, such as elongate wires or ribbons. In some implementations, the extending element may be hollow and protect from abrasion, buckling, or damage at the inputs and outputs of the hubs. In some embodiments, the hollow extending element may be a hollow and flexible coating attached to a hub. The hollow, extending element (e.g., a hollow and flexible coating) may cover a portion of the device shaft when threaded through the hubs. In some embodiments, the hollow extending element is a set of telescoping portions that nest inside each other and enclose a shaft between the hubs. In some embodiments, the hollow extending element has a proximal (closest to insertion point) and distal end (farthest from insertion point) and each end is coupled to a hub. In some embodiments, the extending element is releasably coupled to a hub on at least one end. In some embodiments in which the hollow extending element is a coating, the coating may be attached to a portion of a hub such that threading the catheter device through the hub 26, 28, or 30 threads the catheter device through the coating as well. In some implementations, an anti-buckling device may be installed on or about or surrounding a device shaft to avoid misalignment or insertion angle errors between hubs or between a hub and an insertion point. The anti-buckling device may be a laser cut hypotube, a spring, telescoping tubes, tensioned split tubing, or the like.
In some implementations, a number of deflection sensors may be placed along a catheter length to identify buckling. Identifying buckling may be performed by sensing that a hub is advancing distally, while the distal tip of the catheter or interventional device has not moved. In some implementations, the buckling may be detected by sensing that an energy load (e.g., due to friction) has occurred between catheter shafts.
Alternatively, thin tubular stiffening structures can be embedded within or carried over the outside of the device wall, such as a tubular polymeric extrusion or length of hypo-tube. Alternatively, a removable stiffening mandrel may be placed within a lumen in the proximal segment of the device, and proximally removed following distal advance of the hub towards the patient access site, to prevent buckling of the proximal shafts during distal advance of the hub. Alternatively, a proximal segment of one or more of the device shafts may be constructed as a tubular hypo tube, which may be machined (e.g., with a laser) so that its mechanical properties vary along its length. This proximal segment may be formed of stainless steel, nitinol, and/or cobalt chrome alloys, optionally in combination with polymer components which may provide for lubricity and hydraulic sealing. In some embodiments, this proximal segment may be formed of a polymer, such as polyether ether ketone (PEEK). Alternatively, the wall thickness or diameter of the interventional device can be increased in the anti-buckling zone.
In certain embodiments, a device shaft having advanced stiffness (e.g., axially and torsionally) may provide improved transmission of motion from the proximal end of the device shaft to the distal end of the device shaft. For example, the device shafts may be more responsive to motion applied at the proximal end. Such embodiments may be advantageous for robotic driving in the absence of haptic feedback to a user.
In some embodiments, a flexible coating can be applied to a device shaft and/or hub to reduce frictional forces between the device shaft and/or hub and a second device shaft when the second device shaft passes therethrough.
The interventional device hubs may be separated from the support table 20 by sterile barrier 32. Sterile barrier 32 may comprise a thin plastic membrane such as polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polyethylene terephthalate (PETE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS), or styrene. This allows the support table 20 and associated drive system to reside on a non-sterile (lower) side of sterile barrier 32. The guidewire hub 26, access catheter hub 28, guide catheter hub 30 and the associated interventional devices are all on a sterile (top) side of the sterile barrier 32. The sterile barrier is preferably waterproof and can also serve as a tray used in the packaging of the interventional devices, discussed further below. The interventional devices can be provided individually or as a coaxially preassembled kit that is shipped and stored in the tray and enclosed within a sterile packaging.
Referring to
The length of support surface 104 will typically be at least about 100 centimeters and within the range of from about 100 centimeters to about 2.7 meters. Shorter lengths may be utilized in a system configured to advance the drive couplers along an arcuate path. In some embodiments, two or more support surfaces may be used instead of a single support surface 104. The two or more support surfaces may have a combined length between 100 centimeters to about 2.7 meters. The width of the linear drive table is preferably no more than about 30 to about 80 centimeters.
At least a first channel 106 may be provided, extending axially at least a portion of the length of the support table 20. In the illustrated implementation, first channel 106 extends the entire length of the support table 20. Preferably, the first channel 106 has a sufficient length to hold the interventional devices, and sufficient width and depth to hold the corresponding hubs (for example, by providing lateral support to prevent dislodgment of the hubs when forces are applied to the hubs). First channel 106 is defined within a floor 108, outer side wall 110 and inner side wall 111, forming an upwardly facing concavity. Optionally, a second channel 112 may be provided. Second channel 112 may be located on the same side or the opposite side of the upper support surface 104 from the first channel 106. Two or three or more additional recesses such as additional channels or wells may be provided, to hold additional medical devices or supplies that may be useful during the interventional procedure as well as to collect fluids and function as wash basins for catheters and related devices.
Referring to
The interventional devices may be positioned within the channel 106 and enclosed in a sterile barrier for shipping. At the clinical site, an upper panel of the sterile barrier may be removed, or a tubular sterile barrier packaging may be opened and axially removed from the support table 20 and sterile barrier 32 assembly, exposing the sterile top side of the sterile barrier tray and any included interventional devices. The interventional devices may be separately carried in the channel, or preassembled into an access assembly or procedure assembly, discussed in additional detail below.
A procedure assembly is illustrated in
As is discussed in greater detail in connection with
In certain embodiments, the catheter 31 may be a ‘large bore’ access catheter or guide catheter having an inner diameter of at least about 0.075 inches or at least an inner diameter of about 0.080 inches. The catheter 120 may be an aspiration catheter having an inner diameter within the range of from about 0.060 to about 0.075 inches. The catheter 124 may be a steerable catheter with a deflectable distal tip, having an inner diameter within the range of from about 0.025 to about 0.050 inches. The guidewire (or guiding element) 27 may have an outer diameter within the range of from about 0.014 to about 0.020 inches. In one example, the catheter 31 may have an inner diameter of about 0.088 inches, the catheter 120 an inner diameter of about 0.071 inches, the catheter 124 an inner diameter of about 0.035 inches, and the guidewire 27 may have an outer diameter of about 0.018 inches. In another example, the catheter 31 may have an inner diameter of about 0.088 inches, the catheter 120 an inner diameter of about 0.071 inches, the catheter 124 an inner diameter of about 0.045 inches, and the guidewire 27 may have an outer diameter of about 0.018 inches.
In one commercial execution, a preassembled access assembly (guide catheter, access catheter and guidewire) may be carried within a first channel on the sterile barrier tray and a preassembled procedure assembly (one or two procedure catheters and a guidewire) may be carried within the same or a different, second channel on the sterile barrier tray. One or two or more additional catheters or interventional tools may also be provided, depending upon potential needs during the interventional procedure.
The trough 240 can include a drain hole 242. The trough 240 can be shaped, dimensioned, and/or otherwise configured so that fluid within the trough 240 empties to the drain hole 242. The drain hole 242 can include tubing, a barb fitting, and/or an on-off valve for removal of fluids from the trough 240. As shown in
A first channel 206 may extend axially at least a portion of the length of the sterile barrier 232. The channel 206 can have a sufficient length to hold the interventional devices, and sufficient width and depth to hold the corresponding hubs (for example, by providing support to prevent dislodgement of the hubs when forces are applied to the hubs). Optionally, a second channel 212 may be provided. The second channel 212 may be located on the same side or the opposite side of the upper support surface 204 from the first channel 206.
As shown in
Two or three or more additional recesses such as additional channels or wells may be provided, to hold additional medical devices or supplies that may be useful during the interventional procedure as well as to collect fluids and function as wash basins for catheters and related devices.
In some embodiments, the sterile barrier 232 can include one or more structural ribs 236. The sterile barrier 232 can further include one or more frame support bosses 228 and 238.
In the embodiment of the sterile barrier 232 shown in
In some embodiments, a top surface of the support table can include surface features that generally correspond to those of the sterile barrier 232. For example, the support table can include a convex surface configured to correspond to the shape, size, and location of the support surface 204 and/or one or more recesses configured to correspond to the shape, size, and location of the channels 205 and 207.
In alternate embodiments, a planar support surface (for example, support surface 104 of sterile barrier 32) can be positioned at an angle to a horizontal plane to facilitate the draining of fluids. In some embodiments, the sterile barrier and/or support table may be positioned, during part of or the entirety of an interventional procedure, at an angle to a horizontal plane to facilitate the draining of fluids. For example, the sterile barrier and/or support table may be constructed or arranged in an angled arrangement (for example, so that one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate the drainage of fluids. Alternatively, or additionally, a drive mechanism may temporarily tilt the sterile barrier and/or support table (for example, so that one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate the drainage of fluids. For example, the drive mechanism may raise or lower one lateral side of the sterile barrier and/or support table, the proximal end of the sterile barrier and/or support table, and/or the distal end of the sterile barrier and/or support table.
In certain embodiments, a support surface (for example, support surface 104 of sterile barrier 32) can be positioned in a vertical configuration instead in the horizontal configuration shown, for example, in
In some embodiments, the drive system 18 may be positioned, during part of, or the entirety of, an interventional procedure, at an angle to a horizontal plane to facilitate the draining of fluids. For example, the drive system 18 may be constructed or arranged in an angled arrangement (for example, so that one lateral side of the planar support surface is positioned higher than the other lateral side of the planar support surface, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate the drainage of fluids. Alternatively, or additionally, a drive mechanism may temporarily tilt the drive system 18 (for example, so that one lateral side of the drive system 18 is positioned higher than the other lateral side of the drive system 18, the proximal end is higher than the distal end, or the distal end is higher than the proximal end) to facilitate the drainage of fluids. For example, the drive mechanism may raise or lower one lateral side of the system 18, the proximal end of the drive system 18, and/or the distal end of the drive system 18. In some embodiments, the drive system 18 may be angled so that it extends at an angle away from axis point 24 (for example, so that the proximal end is higher than the distal end), for example, to allow for clearance of a patient's feet.
Referring to
To reduce friction in the system, the hub 36 may be provided with at least a first roller 53 and a second roller 55 which may be in the form of wheels or rotatable balls or drums. The rollers space the sterile barrier apart from the surface of the driven magnet 69 by at least about 0.02 centimeters (about 0.008 inches) and generally no more than about 0.08 centimeters (about 0.03 inches). In some implementations, the space is within the range of from about 0.03 centimeters (about 0.010 inches) and about 0.041 centimeters (about 0.016 inches). The space between the drive magnet 67 and driven magnet 69 is generally no more than about 0.38 centimeters (about 0.15 inches) and in some implementations is no more than about 0.254 centimeters (about 0.10 inches) such as within the range of from about 0.216 centimeters (about 0.085 inches) to about 0.229 centimeters (about 0.090 inches). The hub adapter 48 may similarly be provided with at least a first hub adapter roller 59 and the second hub adapter roller 63, which may be positioned opposite the respective first roller 53 and second roller 55 as illustrated in
Referring to
One example of a linear drive table 20 illustrated in
A second drive pulley 64 may engage a second drive belt 66 configured to axially move a second carriage bracket 68 along an axial path on the support table 20. A third drive pulley 70 may be configured to drive a third drive belt 72, to advance a third carriage bracket 73 axially along the support table 20. Each of the carriage brackets may be provided with a drive magnet assembly discussed previously but not illustrated in
A detailed view of a drive system is shown schematically in
Referring to
As seen in
Any of the catheters illustrated, for example, in
Any of the catheters disclosed herein may be provided with an inclined distal tip. Referring to
A reinforcing element 1162 such as a braid and/or spring coil is embedded in an outer jacket 1164 which may extend the entire length of the catheter.
The advance segment 1154 terminates distally in an angled face 1166, to provide a leading side wall portion 1168 having a length measured between the distal end 130 of the marker band 1156 and a distal tip 1172. In some embodiments, the entire distal tip may be shaped to avoid snagging the tip in areas of arterial bifurcation. A trailing side wall portion 1174 of the advance segment 1154, has an axial length in the illustrated embodiment of approximately equal to the axial length of the leading side wall portion 1168 as measured at approximately 180 degrees around the catheter from the leading side wall portion 1168. The leading side wall portion 1168 may have an axial length within the range of from about 0.1 millimeters to about 5 millimeters and generally within the range of from about 1 to 3 millimeters. The trailing side wall portion 1174 may be equal to or at least about 0.1 or 0.5 or 1 millimeter or 2 millimeters or more shorter than the axial length of the leading side wall portion 1168, depending upon the desired performance.
The angled face 1166 inclines at an angle A within the range of from about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. For certain implementations, the angle is within the range of from about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In one implementation, the angle A is about 60 degrees. One consequence of an angle A of less than 90 degrees is an elongation of a major axis of the area of the distal port which increases the surface area of the port and may enhance clot aspiration or retention. Compared to the surface area of the circular port (angle A is 90 degrees), the area of the angled port is generally at least about 105 percent, and no more than about 130 percent, in some implementations within the range of from about 110 percent and about 125 percent, and in one example is about 115 percent of the area of the corresponding circular port (angle A is 90 degrees).
In the illustrated embodiment, the axial length of the advance segment is substantially constant around the circumference of the catheter, so that the angled face 1166 is approximately parallel to the distal surface 1176 of the marker band 1156. The marker band 1156 has a proximal surface approximately transverse to the longitudinal axis of the catheter, producing a marker band 1156 having a right trapezoid configuration inside elevational view. A short sidewall 1178 is rotationally aligned with the trailing side wall portion 1174 and has an axial length within the range of from about 0.2 millimeters to about 4 millimeters, and typically from about 0.5 millimeters to about 2 millimeters. An opposing long sidewall 1180 is rotationally aligned with the leading side wall portion 1168. Long sidewall 1180 of the marker band 1156 is generally at least about 10 percent or 20 percent longer than short sidewall 1178 and may be at least about 50 percent or 70 percent or 90 percent or more longer than short sidewall 1178, depending upon desired performance. Generally, the long sidewall 1180 will have a length of at least about 0.5 millimeters or 1 millimeter and less than about 5 millimeters or 4 millimeters.
The marker band may be a continuous annular structure, or may have at least one and optionally two or three or more axially extending slits throughout its length. The slit may be located on the short sidewall 1178 or the long sidewall 1180 or in between, depending upon desired bending characteristics. The marker band may comprise any of a variety of radiopaque materials, such as a platinum/iridium alloy, with a wall thickness preferably no more than about 0.003 inches and in one implementation is about 0.001 inches.
The fluoroscopic appearance of the marker bands may be unique or distinct for each catheter size or type when a plurality of catheters is utilized so that the marker bands can be distinguishable from one another by a software algorithm. Distinguishing the marker bands of a plurality of catheters may be advantageous when the multiple catheters are used together, for example, in a multi catheter assembly or stack as described herein. In some embodiments, the marker band of a catheter may be configured so that a software algorithm can detect motion of the catheter tip.
The marker band zone of the assembled catheter may have a relatively high bending stiffness and high crush strength, such as at least about 50 percent or at least about 100 percent less than proximal segment 18 but generally no more than about 200 percent less than proximal segment 1158. The high crush strength may provide radial support to the adjacent advance segment 1154 and particularly to the leading side wall portion 1168, to facilitate the functioning of distal tip 1172 as an atraumatic bumper during transluminal advance and to resist collapse under vacuum. The proximal segment 1158 preferably has a lower bending stiffness than the marker band zone, and the advance segment 1154 preferably has even a lower bending stiffness and crush strength than the proximal segment 1158.
The advance segment 1154 may comprise a distal extension of the outer tubular jacket 1164 and optionally the inner liner 1160, without other internal supporting structures distally of the marker band 1156. Outer jacket 1164 may comprise extruded polyurethane, such as Tecothane® or NEUsoft™. The advance segment 1154 may have a bending stiffness and radial crush stiffness that is no more than about 50 percent, and in some implementations no more than about 25 percent or 15 percent or 5 percent or less than the corresponding value for the proximal segment 1158.
The catheter may further comprise an axial tension element or support such as a ribbon or one or more filaments or fibers for increasing the tension resistance and/or influencing the bending characteristics in the distal zone. The tension support may comprise one or more axially extending mono strand or multi strand filaments. The one or more tension element 1182 may be axially placed inside the catheter wall near the distal end of the catheter. The one or more tension element 1182 may serve as a tension support and resist tip detachment or elongation of the catheter wall under tension (e.g., when the catheter is being proximally retracted through a kinked outer catheter or tortuous or narrowed vasculature).
At least one of the one or more tension element 1182 may proximally extend along the length of the catheter wall from within about 1.0 centimeters from the distal end of the catheter to less than about 10 centimeters from the distal end of the catheter, less than about 20 centimeters from the distal end of the catheter, less than about 30 centimeters from the distal end of the catheter, less than about 40 centimeters from the distal end of the catheter, or less than about 50 centimeters from the distal end of the catheter.
The one or more tension element 1182 may have a length greater than or equal to about 40 centimeters, greater than or equal to about 30 centimeters, greater than or equal to about 20 centimeters, greater than or equal to about 10 centimeters, or greater than or equal to about 5 centimeters.
At least one of the one or more tension element 1182 may extend at least about the most distal 50 centimeters of the length of the catheter, at least about the most distal 40 centimeters of the length of the catheter, at least about the most distal 30 centimeters or 20 centimeters or 10 centimeters of the length of the catheter.
In some implementations, the tension element extends proximally from the distal end of the catheter along the length of the coil 24 and ends proximally within about 5 centimeters or 2 centimeters or less either side of a transition between a distal coil and a proximal braid. The tension element may end at the transition without overlapping with the braid.
The one or more tension element 1182 may be placed near or radially outside the inner liner 1160. The one or more tension element 1182 may be placed near or radially inside the braid and/or the coil. The one or more tension element 1182 may be carried between the inner liner 1160 and the helical coil and may be secured to the inner liner or other underlying surface by an adhesive prior to addition of the next outer adjacent layer such as the coil. Preferably, the tension element 1182 is secured to the marker band 1156 such as by adhesives or by mechanical interference. In one implementation, the tension element 1182 extends distally beyond the marker band on a first (e.g., inside) surface of the marker band, then wraps around the distal end of the marker band and extends along a second (e.g., outside) surface in either, or both, a proximal inclined or circumferential direction to wrap completely around the marker band.
When more than one tension element 1182 or filament bundles are spaced circumferentially apart in the catheter wall, the tension elements 1182 may be placed in a radially symmetrical manner. For example, the angle between two tension elements 1182 with respect to the radial center of the catheter may be about 180 degrees. Alternatively, depending on desired clinical performances (e.g., flexibility, trackability), the tension elements 1182 may be placed in a radially asymmetrical manner. The angle between any two tension elements 1182 with respect to the radial center of the catheter may be less than about 180 degrees, less than or equal to about 165 degrees, less than or equal to about 135 degrees, less than or equal to about 120 degrees, less than or equal to about 90 degrees, less than or equal to about 45 degrees or, less than or equal to about 15 degrees.
The one or more tension element 1182 may comprise materials such as Vectran®, Kevlar®, Polyester®, Spectra®, Dyneema®, Meta-Para-Aramide®, or any combinations thereof. At least one of the one or more tension element 1182 may comprise a single fiber or a multi-fiber bundle, and the fiber or bundle may have a round or rectangular (e.g., ribbon) cross section. The terms fiber or filament do not convey composition, and they may comprise any of a variety of high tensile strength polymers, metals or alloys depending upon design considerations such as the desired tensile failure limit and wall thickness. The cross-sectional dimension of the one or more tension element 1182, as measured in the radial direction, may be no more than about 2 percent, 5 percent, 8 percent, 15 percent, or 20 percent of that of the catheter 10.
The cross-sectional dimension of the one or more tension element 1182, as measured in the radial direction, may be no more than about 0.03 millimeters (about 0.001 inches), no more than about 0.0508 millimeters (about 0.002 inches), no more than about 0.1 millimeters (about 0.004 inches), no more than about 0.15 millimeters (about 0.006 inches), no more than about 0.2 millimeters (about 0.008 inches), or about 0.38 millimeters (about 0.015 inches).
The one or more tension element 1182 may increase the tensile strength of the distal zone of the catheter before failure under tension (e.g., marker band detachment) to at least about 1 pound, at least about 2 pounds, at least about 3 pounds, at least about 4 pounds, at least about 5 pounds, at least about 6 pounds, at least about 7 pounds, at least about 8 pounds, or at least about 10 pounds or more.
Any of a variety of sensors may be provided on any of the catheters, hubs, carriages, or table, depending upon the desired data. For example, in some implementations, it may be desirable to measure axial tension or compression force applied to the catheter such as along a force sensing zone. The distal end of the catheter would be built with a similar construction as illustrated in
This construction of double, electrically isolated helical coils creates a capacitor. This is roughly equivalent to two plates of nitinol with a plastic layer between them, illustrated in
At least a first helical capacitor may have at least one or five or ten or more complete revolutions of each wire. A capacitor may be located within the distal most 5 or 10 or 20 centimeters of the catheter body to sense forces experienced at the distal end. At least a second capacitor may be provided within the proximal most 5 or 10 or 20 centimeters of the catheter body, to sense forces experienced at the proximal end of the catheter.
It may also be desirable to measure clastic forces across the magnetic coupling between the hub and corresponding carriage, using the natural springiness (compliance) of the magnetic coupling to measure the force applied to the hub. The magnetic coupling between the hubs and carriages creates a spring. When a force is applied to the hub, the hub will move a small amount relative to the carriage. See
The relative distance could be measured in multiple different ways. One method for measuring the relative distance between the hub and carriage is a magnetic sensor (e.g., a Hall effect Sensor between hub and carriage). A magnet is mounted to either the hub or carriage, and a corresponding magnetic sensor is mounted on the other device (carriage or hub). The magnetic sensor might be a hall effect sensor, a magneto-resistive sensor, or another type of magnetic field sensor. Generally, multiple sensors may be used to increase the reliability of the measurement. This reduces noise and reduces interference from external magnetic fields.
Other non-contact distance sensors can also be used. These include optical sensors, inductance sensors, and capacitance sensors. Optical sensors would preferably be configured in a manner that avoids accumulation of blood or other fluid in the interface between the hubs carriages. In some implementations, wireless (i.e., inductive) power may be used to translate movement and/or transfer information across the sterile barrier between a drive carriage and a hub, for example.
The magnetic coupling between the hub and the carriage has a shear or axial break away threshold which may be about 300 grams or 1000 grams or more. The processor can be configured to compare the axial force applied to the catheter to a preset axial trigger force which if applied to the catheter is perceived to create a risk to the patient. If the trigger force is reached, the processor may be configured to generate a response such as a visual, auditory, or tactile feedback to the physician, and/or intervene and shut down further advance of the catheter until a reset is accomplished. An override feature may be provided so the physician can elect to continue to advance the catheter at forces higher than the trigger force, in a situation where the physician believes the incremental force is warranted.
Force and or torque sensing fiber optics (e.g., Fiber Bragg Grating (FBG) sensors) may be built into the catheter side wall to measure the force and/or torque at various locations along the shaft of a catheter or alternatively may be integrated into a guidewire. The fiber measures axial strain, which can be converted into axial force or torque (when wound helically). At least a first FBG sensor can be integrated into a distal sensing zone, proximal sensing zone and/or intermediate sensing zone on the catheter or guidewire, to measure force and or torque in the vicinity of the sensor.
It may also be desirable to understand the three-dimensional configuration of the catheter or guidewire during and/or following transvascular placement. Shape sensing fiber optics such as an array of FBG fibers to sense the shape of catheters and guidewires. By using multiple force sensing fibers that are a known distance from each other, the shape along the length of the catheter/guidewire can be determined.
A strain gauge may be integrated into the body of the catheter or guidewire to measure force or torque. In an example, the string gauge is a resistive strain gauge. In some embodiments, the strain gauge is incorporated in the distal tip of the catheter, or incorporated in the proximal end of the catheter, and/or incorporated in the proximal end of the catheter and the proximal end of the catheter. In some embodiments, a strain gauge could be deposited on a wall of the catheter via thin film deposition technologies.
Measurements of force and/or torque applied to the catheter or guidewire shafts can be used to determine applied force and/or torque above a safety threshold. When an applied force and/or torque exceeds a safety threshold, a warning may be provided to a user. Applied force and/or torque measurements may also be used to provide feedback related to better catheter manipulation and control. Applied force and/or torque measurements may also be used with processed fluoroscopic imaging information to determine or characterize distal tip motion.
Absolute position of the hubs (and corresponding catheters) along the length of the table may be determined in a variety of ways. For example, a non-contact magnetic sensor may be configured to directly measure the position of the hubs through the sterile barrier. The same type of sensor can also be configured to measure the position of the carriages. Each hub may have at least one magnet attached to it. The robotic table would have a linear array of corresponding magnetic sensors going the entire length of the table. A processor can be configured to determine the location of the magnet along the length of the linear sensor array and display axial position information to the physician.
The foregoing may alternatively be accomplished using a non-contact inductive sensor to directly measure the position of the hubs through the sterile barrier. Each hub or carriage may be provided with an inductive “target” in it. The robotic table may be provided with an inductive sensing array over the entire working length of the table. As a further alternative, an absolute linear encoder may be used to directly measure the linear position of the hubs or carriages. The encoder could use any of a variety of different technologies, including optical, magnetic, inductive, and capacitive methods.
In one implementation, a passive (no electrical connections) target coil may be carried by each hub. A linear printed circuit board (PCB) may run the entire working length of the table (e.g., at least about 1.5 meters to about 1.9 meters) configured to ping an interrogator signal which stimulates a return signal from the passive coil. The PCB is configured to identify the return signal and its location.
Axial position of the carriages may be determined using a multi-turn rotary encoder to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage. Direct measurement of the location of the carriage may alternatively be accomplished by recording the number of steps commanded to the stepper motor to measure the rotational position of the pulley, which directly correlates to the linear position of the carriage.
The location of the catheters and guidewires within the anatomy may also be determined by processing the fluoroscopic image with machine vision, such as to determine the distal tip position, distal tip orientation, and/or guidewire shape. Comparing distal tip position or movement or lack thereof to commanded or actual proximal catheter or guidewire movement at the hub, may be used to detect a loss of relative motion, which may be indicative of a device shaft buckling, prolapse, kinking, or a similar outcome (for example, along the device shaft length inside the body (e.g., in the aorta) or outside the body between hubs. The processing may be done in real time to provide position/orientation data at up to 30 Hertz, although this technique would only provide data while the fluoroscopic imaging is turned on. In some embodiments, machine vision algorithms can be used to generate and suggest optimal catheter manipulations to access or reach anatomical landmarks, similar to driver assist. The machine vision algorithms may utilize data to automatically drive the catheters depending on the anatomy presented by fluoroscopy. Machine vision could also be used to analyze catheter straightness relative to build up tension. As tension builds up in the catheter due to navigating anatomical tortuosity, the catheter will begin to bow and buckle in a sinusoidal manner thus becoming less straight. This tension build can lead to more severe prolapse if built up enough. Measuring the loss of straightness could be a signal to stop before prolapse can happen. This can be particularly helpful when the area of prolapse is outside of the current x-ray view.
Proximal torque applied to the catheter or guidewire shaft may be determined using a dual encoder torque sensor. Referring to
Confirming the absence of bubbles in fluid lines may also be accomplished using bubble sensors, particularly where the physician is remote from the patient. This may be accomplished using a non-contact ultrasonic sensor that measures the intensity and doppler shift of the reflected ultrasound through the sidewall of fluid tubing to detect bubbles and measure fluid flow rate or fluid level. An ultrasonic or optical sensor may be positioned adjacent an incoming fluid flow path within the hub, or in a supply line leading to the hub. To detect the presence of air bubbles in the infusion line (that is formed of ultrasonically or optically transmissive material) the sensor may include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure transmission through the liquid passing through the tube to detect bubbles. Alternatively, a reflected ultrasound signal may be detected from the same side of the flow path as the source due to the relatively high echogenicity of bubbles.
Preferably, a bubble removal system is automatically activated upon detection of in line bubbles. A processor may be configured to activate a valve positioned in the flow path downstream of the bubble detector, upon the detection of bubbles. The valve diverts a column of fluid out of the flow path to the patient and into a reservoir. Once bubbles are no longer detected in the flow path and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve may be activated to reconnect the source of fluid with the patient through the flow path. In some embodiments, bubbles could be dislodged from the catheter wall via a beam ultrasonic energy coming from an ultrasound transducer. In other embodiments, the bubble removal system can include a pump and control system upstream of the bubble detector for removal of in line bubbles. A processor may be configured to activate the pump upon detection of bubbles to reverse the fluid flow and clear the bubbles into a waste reservoir before reestablishing bubble free forward flow.
It may additionally be desirable for the physician to be able to view aspirated clot at a location within the sterile field and preferably as close to the patient as practical for fluid management purposes. This may be accomplished by providing a clot retrieval device mounted on the hub, or in an aspiration line leading away from the hub in the direction of the pump. Referring to
In some embodiments, the body 380 includes a housing having a top portion 382 and a bottom portion 384. The body 380 may include a filter 330 positioned in the chamber 381 between the top portion 382, and the bottom portion 384. In some examples, the first port 310 is configured to connect to a first end of a first tube 340 that is fluidly connected to a proximal end of an aspiration catheter.
In an embodiment that is configured to be connected downstream from the hub, the first tube 340 includes a connector 342 positioned at a second end of the first tube 340 that is configured to engage or mate with a corresponding connector on or in communication with the hub. The first port 310 directly communicates with the chamber on the upstream (e.g., top side) of the filter, and the second port 320 directly communicates with the chamber on the downstream (e.g., bottom side) of the filter to facilitate direct visualization of material caught on the upstream side of the filter.
In an implementation configured for remote operation, any of a variety of sensors may be provided to detect clot passing through the aspiration line and/or trapped in the filter, such as an optical sensor, pressure sensor, flow rate sensor, ultrasound sensor or others known in the art.
In some embodiments, the second port 320 is configured to connect to a first end of a second tube 350 that is fluidly connected to an aspiration source (e.g., a pump). In some embodiments, the second tube 350 includes a connector 352 positioned at a second end of the second tube 350 that is configured to engage or mate with a corresponding connector on the pump.
In some examples, the system 300 can include an on-off valve 360 such as a clamp 360. The clamp 360 can be positioned in between the filter 330 and the patient, such as over the first tube 340 to allow the user to engage the clamp and provide flow control by isolating the patient from the clot retrieval device 370. Closing the valve 360 and operating the remote vacuum pump (not illustrated) causes the canister associated with the vacuum pump and the chamber 381 to reach the same low pressure. Due to the short distance and small line volume of the lumen between the chamber 381 end the distal end of the catheter, a sharp negative pressure spike is experienced at the distal end of the catheter rapidly following opening of the valve 360. Additional details are disclosed in U.S. Pat. No. 11,259,821 issued Mar. 1, 2022, to Buck et al., entitled Aspiration System with Accelerated Response, the entirety of which is hereby expressly incorporated by reference herein. In some embodiments, a vacuum may be cycled against a clot to retrieve the clot. The vacuum may be automatically and robotically controlled to remove the clot.
The body 380 can have a top surface spaced apart from a bottom surface by a tubular side wall. In the illustrated implementation, the top and bottom surfaces are substantially circular, and spaced apart by a cylindrical side wall. The top surface may have a diameter that is at least about three times, or five times or more than the axial length (transverse to the top and bottom surfaces) of the side wall, to produce a generally disc shaped housing. Preferably at least a portion of the top wall is optically transparent to improve clot visualization once it is trapped in the clot retrieval device 370. Additional details may be found in PCT/US2022/078113, filed on Oct. 14, 2022, the entirety of which is hereby incorporated by reference herein.
In some examples, the body 380 can include a flush port (not illustrated) that is configured to allow the injection of an optically transparent media such as air, saline or other fluid into the chamber 381 to clear an optical path between the window and the filter to improve clot visualization once it is trapped in the filter 330.
The foregoing represents certain specific implementations of a drive table and associated components and catheters. A wide variety of different drive table constructions can be made, for supporting and axially advancing and retracting two or three or four or more drive magnet assemblies to robotically drive interventional devices, fluid elements, and electrical umbilical elements for communicating electrical signals and fluids to the catheter hubs, as will be appreciated by those of skill in the art in view of the disclosure herein. Additional details may be found in U.S. patent application Ser. No. 17/527,393, filed on Nov. 16, 2021, the entirety of which is hereby incorporated by reference herein.
While the foregoing describes robotically driven interventional devices and manually driven interventional devices, the devices may be manually driven, robotically driven, or a combination of both manually and robotically driven interventional devices, as will be appreciated by those of skill in the art in view of the disclosure herein.
As shown in
The control mechanism 2200 may be positioned on or near to a patient support table having a set of hubs and catheters/interventional devices. In some implementations, the control mechanism 2200 may be positioned remote from the support table such as behind a radiation shield or in a different room or different geographical location in a telemedicine implementation.
Each control 2202-2208 may correspond to and drive movement of a hub and/or a hub and interventional device combination. For example, the control 2202 may be configured to drive hub 30 (
Other axes and degrees of freedom may be defined to enable control 2202 to perform movements that may be translated to movement of hubs and/or interventional devices. For example, the control mechanism may be provided with one or more deflection controls configured to initiate a lateral deflection in a deflection zone on the corresponding interventional device.
Axial movement of a control may be configured to move the coupled hub on a 1:1 basis, or on a non 1:1 scaled basis. For example, if the user 2230 advances the control 2022 about 5 millimeters distally along the shaft 2210, then the corresponding hub may responsively move 5 millimeters in the distal direction.
If the user 2230 rotates the control 2022 about its rotational axis by 5 degrees, the coupled hub will cause the corresponding interventional device to rotate on a 1:1 basis or on a non 1:1 scaled basis. The scaled amount may be selected to reduce or increase the amount of distance and rotation that a hub and/or interventional device moves in accordance with the control movement.
In some implementations, the scaled amount described herein may be determined using a scale factor. The scale factor may apply to one or both translational and rotational movement. In some implementations, a first scale factor is selected for translational movement and a second scale factor, different than the first scale factor, is selected for rotational movement. The axial scaling factor may drive proximal catheter movement at a faster speed than distal catheter movement for a given proximal or distal manipulation of the control.
The rotational scale factor may be 1:1 while the axial scale factor may move the hub by a greater distance than movement of the control such that hub travel to control travel is at least about 2:1 or 5:1 or 10:1 or more depending upon the desired axial length of the control assembly.
The control mechanism 2200 may be configured to enable the clinician to adjust the scale factor for different parts of the procedure. For example, distal advance of the procedure catheter and access catheter through the guide catheter and up to the selected ostium may desirably be accomplished in a ‘fast’ mode. But more distal travel into the neuro vasculature may desirably be accomplished in a relatively slow mode by actuation of a speed control.
In another implementation, one or more controls may be configured to progressively drive advance or retraction speeds of the corresponding hub and associated catheter. For example, distal control 2202 may drive the guide catheter. A slight distal movement of the control 2202 may advance the guide catheter distally at a slow speed, while advancing the control 2202 by a greater distance distally increases the rate of distal travel of the guide catheter.
Controlling the speed of the corresponding hubs either axially or both axially and rotationally may enhance the overall speed of the procedure. For example, advance of the various devices from the femoral access point up to the aortic arch may desirably be accomplished at a faster rate than more distal navigation closer to the treatment site. Also, proximal retraction of the various devices, particularly the guidewire, access catheter and procedure catheter may be desirably accomplished at a relatively higher speeds than distal advance.
In some implementations, each control mechanism and/or additional controls (not shown) may be color coded, shaped coded, tactile coded, or other coding to indicate to the user 2230 which color is configured to move which hub or interventional device. In some implementations, the control color coding may also be applied to the hubs and/or interventional devices such that a user may visually match a particular hub/device with a particular control.
In some implementations, other control operations beyond translational movement and rotational movement may be carried out using controls 2202-2208. For example, controls 2202-2208 may be configured to drive a shape change and/or stiffness change of a corresponding interventional device. Controls 2202-2208 may be toggled between different operating modes. For example, controls 2202-2208 may be toggled between movement driven by acceleration and velocity to movement that reflects actual linear displacement or rotation.
In some implementations, the control mechanism 2200 may be provided with a visual display or other indicator of the relative positions of the controls which may correspond the relative positions of the interventional devices. Such displays may depict any or all movement directions, instructions, percentage of movements performed, and/or hub and/or catheter indicators to indicate which device is controlled by a particular control. In some implementations, the display may depict applied force or resistance encountered by the catheter or other measurement being detected or observed by a particular hub or interventional component.
In some implementations, the control mechanism 2200 may include haptic components to provide haptic feedback to a user operating the controls. For example, if the control 2202 is triggering movement of a catheter and the catheter detects a large force at the tip, the control 2202 may generate haptic feedback to indicate to the user to stop or reverse a performed movement. In some implementations, haptic feedback may be generated at the control to indicate to the user to slow or speed a movement using the control. In some implementations, haptics may provide feedback on a large torsional strain buildup that might precede an abrupt rotation, or a large axial force buildup that may be a prelude to buckling of the catheter.
The systems described herein may compare an actual fluoroscopic image position to an input displacement from the controller. A static fluoroscopic image of the patient may be captured in which the patient's vasculature is indexed relative to bony landmarks or one or more implanted soft tissue fiducial markers. Then a real time fluoroscopic image may be displayed as an overlay, aligned with the static image by registration of the fiducial markers. Visual observation of conformance of the real time movement with the static image, assisted by detected force data can help confirm proper navigation of the associated catheter or guidewire. The systems described herein can also display a comparison of an input proximal mechanical translation of a catheter or guidewire and a resulting distal tip output motion or lack thereof. A loss of relative motion at the distal tip may indicate shaft buckling, prolapse, kinking, or a similar outcome, either inside or outside the body. Such a comparison may be beneficial when the shaft buckling, prolapse, kinking, or similar outcome occurs outside of a current fluoroscopic view.
The interventional device assembly 2900 includes an insert or access catheter 2902, a procedure catheter 2904, and a guide catheter 2906. Other components are possible including, but not limited to, one or more guidewires (e.g., optional guidewire 2907), one or more guide catheters, an access sheath and/or one or more other procedure catheters and/or associated catheter (control) hubs. In some embodiments, the assembly 2900 may also be configured with an optional deflection control 2908 for controlling deflection of one or more catheters of assembly 2900.
In operation, the multi-catheter assembly 2900 may be used without having to exchange hub components. For example, in the two-stage procedure disclosed previously, a first stage for achieving supra-aortic access, includes mounting an access catheter, guide catheter and guidewire to the support table. Upon gaining supra-aortic access, the access catheter and guidewire were typically removed from the guide catheter. Then, a second catheter assembly is introduced through the guide catheter after attaching a new guidewire hub and a procedure catheter hub to the corresponding drive carriage on the support table.
The single multi catheter assembly 2900 of
Once access above the aortic arch has been achieved, the insert or access catheter 2902 (associated with insert catheter hub 2910) may be “parked,” for example, in the vicinity of a carotid artery ostia, and the remainder or a subset of the catheter assembly may be guided more distally toward a particular site (e.g., a clot site, a surgical site, a procedure site, etc.).
In some embodiments, other smaller procedure catheters may also be added and used at the site. In some implementations, for catheter assembly 2900, in a robotic configuration of assembly 2900, the catheter 2906 may function as a guide catheter. The catheter 2904 may function as a procedure (e.g., aspiration) catheter. In some embodiments, the catheter 2906 may function to perform aspiration in addition to functioning as a guide catheter, either instead of, or in addition to, the catheter 2904. The access catheter 2902 may have a distal deflection zone and can function to access a desired ostium. One of skill in the art will appreciate from
In some embodiments, the catheter assembly 2900 (or other combined catheter assemblies described herein) may be driven as a unit to a location. However, each catheter (or guidewire) component may instead be operated and driven independent of one another to the same or different locations. Since each catheter will have its own stiffness profile relative to length, the position and superposition of the catheters can be adjusted to find the corresponding optimal stiffness profile to help navigate the catheter stack past various anatomical obstacles.
In a non-limiting example, the catheter assembly 2900 may be used for a diagnostic angiogram procedure. In some embodiments, the assembly 2900 may include only the guidewire 2907 and access catheter 2902 (in the form of a diagnostic angiographic catheter) for performing the diagnostic angiogram procedure or only the guidewire 2907 and the access catheter 2902 may be utilized during the procedure. Alternatively, the guide catheter 2906 and procedure catheter 2904 may be retracted proximally to expose the distal end of the access catheter 2902 (e.g., a few centimeters of the distal end of the access catheter) to perform the diagnostic angiography.
As shown in
In some embodiments, the access catheter 2902 may have an inner diameter 35 of about between 0.046 to 0.047 inches, and the guidewire 2907 may have an outer diameter 33 of less than or equal to 0.024 inches, for example, an outer diameter 33 in the range between about 0.014 and about 0.024 inches. These configuration provides sufficient annular space within the lumen of access catheter 2902 for contrast media to propagate through the lumen of the access catheter 2902 so the guidewire 2907 may remain in place while contrast media is injected into the catheter assembly 2900. This advantageously shortens the time of the overall procedure by eliminating the need to remove the guidewire 2907 each time contrast media is to be injected to create enough annular space within the lumen of the access catheter 2902 for the contrast media to flow through the lumen of the access catheter 2902. For example, these configurations provide allow for contrast to flow inside a catheter at a flow rate of about 3 cc's per second, at a pressure not to exceed 400 psi. In some examples, such a catheter is between about 100 cm and 160 cm in length. Additionally, this configuration lowers the risk of air embolisms associated with the repeated removal and re-insertion of the guidewire 2907 from, and into, the catheter assembly 2900.
As described further in reference to the examples/trails, to provide a desired fluid flow through the access catheter 2902 while the guiding element 2907 is positioned within the access catheter 2902, a certain effective cross-sectional area 41 of the access catheter 2902 should be available to communicate fluid from the proximal end of the catheter to the distal end and out of the access catheter. In reference to
Various dimensions of the outside diameter 33 of the guiding element 2907 and the inside diameter 35 of the access catheter 2902 can be utilized to achieve an effective cross-sectional area of at least about 0.001257 square inches as shown in the table below, which shows examples of determined effective cross-sectional areas of the access catheter for various access catheter inner diameter dimensions and various guiding element (GE) outer diameter dimensions where the shaded cells indicate effective cross-sectional areas that fall below the threshold of 0.001257 square inches. In an example, as illustrated in the table an access catheter ID of 0.045″ and a guiding element OD of 0.020″ provides an effective cross-sectional area of the access catheter of 0.001276 square inches which is acceptable (un-shaded) because it is above the threshold value of 0.001257 square inches. In another example, as illustrated in the table an access catheter ID of 0.045″ and a guiding element OD of 0.021″ provides an effective cross-sectional area of the access catheter of 0.001244 square inches which is unacceptable (shaded) because it is below a (predetermined) threshold value of 0.001257 square inches. Although the table below illustrates some examples, others example configurations are also possible that meet this threshold.
In some embodiments, the length of the access catheter 2902 may be between about 100 and 193 centimeters. In certain embodiments, a wall of the access catheter 2902 surrounding the lumen may include a braided reinforcement layer and an interior liner (e.g., PEBAX). The braided reinforcement layer may include stainless metal ribbon wire in a tight braid pattern. In an example, the metal ribbon wire can have a cross-sectional dimension of about 0.002″ x about 0.005″. In other embodiments, the braided reinforcement layer may include a stainless metal round wire having a 0.002 inch diameter in a tight braid pattern (e.g., a 1:1 braid pattern, or a 2:2 braid pattern). In various examples, the ribbon material could be made from, or include, stainless steel or other materials, including titanium, CoCr alloys, Elgiloy, Hasteloy (Hastelloy alloy), or the like.
The guide catheter 2906 and the access catheter 2902 may each have a proximal end 1810 and a distal end 1812. In some embodiments, the distal ends 1812 of guide catheter 2906 and access catheter 2902 may each have a hypotube tip, 1806 and 1802 respectively, as shown in
While the embodiments disclosed herein are described with respect to the injection of contrast media, those of skill in the art would appreciate that these concepts may be applicable to any fluid injected into the catheter assembly 2900 (e.g., saline, medicament, etc.). The viscosity of the liquid being injected into the catheter assembly 2900 may affect the annular space required in the lumen of the access catheter 2902 to allow for sufficient flow rate. Accordingly, access catheters 2902 of different diameters and/or lengths than those described above may be desirable depending on the viscosity of the liquid being injected into the catheter assembly 2900. Similarly, guidewires of different diameters or having different properties (e.g, having a hydrophilic coating) may be desirable depending on the properties of the liquid being injected into the catheter system to facilitate desired flow characteristics. In some embodiments, a guiding element (e.g., guidewire) can include different surface properties on its proximal end and distal end. In an example, a guiding element can include a hydrophilic coating on its distal end and a hydrophobic coating on its proximal end. In an example, the hydrophobic coating is polytetrafluoroethylene (PTFE). In an example, the hydrophobic coating comprises a PTFE-based composition. In an example, the PTFE-based composition is Teflon™. The examples detailed at the end of this disclosure illustrate different configurations of some embodiments of the catheter assembly 2900 that may be used.
Referring to
Referring to
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The catheter assembly 2900 may be used to perform a neurovascular procedure, as described in
The neurovascular procedure may further include steps of coupling the assembly to a non-robotic or a robotic drive system and driving the assembly to achieve supra-aortic access. The steps may further include driving a subset of the assembly to a neurovascular site and performing the neurovascular procedure using a subset of the assembly. The subset of the assembly may include the guidewire, the guide catheter, and the procedure catheter.
Each of the guidewire 2907, the access catheter 2902, the procedure catheter 2904, and the guide catheter 2906 is configured to be adjusted by a respective hub. For example, the guidewire 2907 may include (or be coupled to) a hub installed on one of the tray assemblies described herein (for example, hub 26,
In general, coupling of the assembly 2900 may include magnetically coupling a first hub 2909, which is coupled to the guidewire 2907, to a first drive magnet; magnetically coupling a second hub 2910, which is coupled to the access catheter 2902, to a second drive magnet; magnetically coupling a third hub 2912, which is coupled to the procedure catheter 2904, to a third drive magnet; and magnetically coupling a fourth hub 2914, which is coupled to the guide catheter 2906, to a fourth drive magnet. In various embodiments, there can be one layer of material, or multiple layers of material (that is, one or more layers of material), between each of the first, second, third, and fourth hubs, and their corresponding first, second, third, and fourth drive magnets, such that the magnetic couplings are through the layer(s) of material. In various embodiments, each layer may be flexible, semi-rigid, or rigid. A layer can be a sterile barrier. When the system is configured for use, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are each independently movable, and movably carried by (or on) a drive table, for example, as described with respect to tray assemblies and controls described herein. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are coupled to their respective catheter hubs through a sterile barrier (e.g., a sterile and fluid barrier). Each of the first, second, third, and fourth drive magnets may be controlled to be independently movable relative to the other drive magnets. Each of the first, second, third, and fourth drive magnets may be incorporated on a drive table having a plurality of drive magnets that are controlled to move along the drive table (for example, along a longitudinal axis of the drive table. In some embodiments, two or more drive magnets can be tethered or otherwise coupled together to move as a unit in response to commands from a single controller. In some examples, the drive magnets can be coupled together to move together (e.g., physically coupled together or configured to move together by a controller). In an example, the first and second drive magnets may be configured to move together along the drive table. In another example, the first, second, third, and fourth drive magnets may be configured to move together. In another example, any two or more of the first, second, third, and fourth drive magnets (and correspondingly, the hubs the first, second, third, and fourth drive magnets are coupled to) may be configured to be moved together along a drive table.
In some implementations, the steps of performing the neurovascular procedure may include driving the assembly in response to movement of hub adapters along a support table until the assembly is positioned to achieve supra-aortic vessel access. The hub adapters may include, for example, a coupler/carriage that acts as a shuttle by advancing proximally or distally along a track in response to operator instructions. The hub adapters described herein may each include at least one drive magnet configured to couple with a magnet (sometimes referred to herein as a “driven magnet”) carried by the respective hub. This provides a magnetic coupling between the drive magnet and driven magnet through the sterile barrier such that the respective hub is moved across the top of the sterile barrier (within the sterile field) in response to movement of the hub adapter which is positioned outside of the sterile field (as described in detail in
Movement of the catheter assembly 2900 during a procedure may include moving including a portion on the catheter assembly 2900. For example, moving the catheter assembly 2900 during a procedure may include driving a subset of the assembly in response to movement of one or more of the hub adapters along the support table until the subset of the assembly is positioned to perform a neurovascular procedure at a neurovascular treatment site. The subset of the assembly may include the guidewire 2907, the guide catheter 2906, and/or the procedure catheter 2904.
In some embodiments, the guidewire 2907, the guide catheter 2906 and the procedure catheter 2904 are advanced as a unit through (with respect to the guidewire 2907) and over (with respect to the guide catheter 2906 and the procedure catheter 2904) at least a portion of a length of the access (e.g., insert) catheter 2902 after supra-aortic access is achieved.
In some embodiments, the catheter assembly 2900 may be part of a robotic control system for achieving supra-aortic access and neurovascular treatment site access, as described in
An example robotic control system may include at least a guidewire hub (e.g., guidewire hub 2909) configured to adjust each of an axial position and a rotational position of a guidewire 2907. The robotic control system may also include an access catheter hub 2910 configured to adjust axial and rotational movement of an access catheter 2902. The robotic control system may also include a guide catheter hub 2914 configured to control axial movement of a guide catheter 2906. The robotic control system may also include a procedure catheter hub 2912 configured to adjust an axial position and a rotational position of a procedure catheter 2904.
In some embodiments, the procedure catheter hub 2912 is further configured to laterally deflect the procedure catheter 2904 through a distal deflection zone.
In some embodiments, the guidewire hub 2909 is configured to couple to a guidewire hub adapter by magnetically coupling the guidewire hub to a first drive magnet. The access catheter hub 2910 is configured to couple to an access catheter hub adapter by magnetically coupling the access catheter hub 2910 to a second drive magnet. The procedure catheter hub 2912 is configured to couple to a procedure catheter hub adapter by magnetically coupling the procedure catheter hub 2912 to a third drive magnet. The guide catheter hub 2914 is configured to couple to a guide catheter hub adapter by magnetically coupling the guide catheter hub 2914 to a fourth drive magnet. In some embodiments, the first drive magnet, the second drive magnet, the third drive magnet, and the fourth drive magnet are independently movably carried by a drive table.
In some embodiments, the robotic control system includes a first driven magnet on the guidewire hub 2909. The first driven magnet may be configured to cooperate with the first drive magnet such that the first driven magnet is configured to move in response to movement of the first drive magnet. In some embodiments, the first drive magnet is configured to move outside of a sterile field separated from the first driven magnet by a barrier while the first driven magnet is within the sterile field. In some embodiments, a position of the first driven magnet is movable in response to manipulation of a procedure drive control on a control console associated with the drive table. Drive magnets and driven magnet interactions are described in detail in
In some embodiments, the robotic control system includes a second driven magnet on the access catheter hub 2910. The second driven magnet may be configured to cooperate with the second drive magnet such that the second driven magnet is configured to move in response to movement of the second drive magnet. In some embodiments, the second drive magnet is configured to move outside of a sterile field separated from the second driven magnet by a barrier while the second driven magnet is within the sterile field.
In some embodiments, the robotic control system includes a third driven magnet on the procedure catheter hub 2912. The third driven magnet may be configured to cooperate with the third drive magnet such that the third driven magnet is configured to move in response to movement of the third drive magnet. In some embodiments, the third drive magnet is configured to move outside of a sterile field separated from the third driven magnet by a barrier while the third driven magnet is within the sterile field.
In some embodiments, the robotic control system includes a fourth driven magnet on the guide catheter hub 2914. The fourth driven magnet may be configured to cooperate with the fourth drive magnet such that the fourth driven magnet is configured to move in response to movement of the fourth drive magnet. In some embodiments, the fourth drive magnet is configured to move outside of a sterile field separated from the fourth driven magnet by a barrier while the fourth driven magnet is within the sterile field. In some embodiments, there may be more than four driven magnets and corresponding catheter hubs for control of additional catheters.
In some embodiments, devices (e.g., hubs, hub adapters, interventional devices, and/or trays) described herein may be used during a robotically driven procedure. For example, in a robotically driven procedure, one or more of the interventional devices may be driven through vasculature and to a procedure site. Robotically driving such devices may include engaging electromechanical components that are controlled by user input. In some implementations, users may provide the input at a control system that interfaces with one or more hubs and hub adapters.
In some embodiments, the hubs, hub adapters, interventional devices, and trays described herein may be used during a non-robotic (e.g., manually driven) procedure. Manually driving such devices may include engaging manually with the hubs to affect movement of the interventional devices.
In some embodiments, the devices described herein may be used to carry out a method of performing an intracranial procedure at an intracranial site. The method of performing the intracranial procedure may include any of the same steps as described herein for performing a neurovascular procedure. The procedure may be robotically performed, manually performed, or a hybridized combination of both.
While the foregoing describes magnetic coupling of hubs to drive magnets, in other embodiments, any of the interventional devices and/or hubs may be mechanically coupled to a drive system. Any of the methods described herein may include steps of mechanically coupling one or more interventional devices (e.g., the guidewire 2907, the access catheter 2902, the procedure catheter 2904, and/or the guide catheter 2906) and/or one or more hubs (e.g., the guidewire hub 2909, the access catheter hub 2910, the procedure catheter hub 2912, and/or the guide catheter hub 2914) with one or more drive mechanisms.
In some embodiments, the structural support can extend through an elongate self-closing seal between two adjacent coaptive edges of flexible material (e.g., similar in shape to a duckbill valve) that extends along an axis. As the structural support advances along the axis between the coaptive edges, the coaptive edges may permit the structural support to advance, and then may be biased back into a sealing engagement with each other as the structural support passes any given point along the axis.
In some embodiments, the drive mechanism may be a splined drive shaft (e.g., a non-sterile splined drive shaft). The mechanical coupling 1654 can include a pulley within a plate that serves as the sterile barrier 1632 and a sterile splined shaft configured to couple to the driven mechanism 1652. The driven mechanism 1652 can be a sterile pulley that receives the sterile splined shaft from the sterile barrier. In some embodiments, one or more splined drive shafts can engage and turn corresponding pulleys in the plate that serves as the sterile barrier. Each hub can have a sterile pulley that is configured to receive a sterile splined shaft from the sterile barrier plate. Rotation of the splined drive shaft can turn the pulley in the sterile barrier plate which can, in turn, turn the sterile pulley in the hub via the sterile splined shaft.
It will be understood by one having skill in the art that any embodiment as described herein may be modified to incorporate a mechanical coupling mechanism, for example, as shown in
The interventional devices described herein may be provided individually, or at least some of the interventional devices can be provided in a preassembled (e.g., nested or stacked) configuration, for example, as part of a sterile kit. In an example, the interventional devices may be provided in the form of an interventional device assembly, such as interventional device assembly 2900, in a concentric nested or stacked configuration. If provided individually, each catheter (and in some embodiments, each corresponding catheter hub) can be unpackaged and primed to remove air from its inner lumen, for example, by flushing the catheter (and in some embodiments, each corresponding catheter hub) to remove air by displacing it with a fluid, such as saline, contrast media, or a mixture of saline and contrast media. After priming, the interventional devices can be manually assembled into a stacked configuration so that they are ready for introduction into the body for a surgical procedure, for example, via an introducer sheath.
Assembling the devices into a stacked configuration can include individually inserting interventional devices into one another by order of size. For example, an interventional device having a second largest diameter can be inserted into the lumen of an interventional device having a largest diameter. An interventional device having a third largest diameter can then be inserted into the interventional device having the second largest diameter and so on.
For example, with respect to
Embodiments in which two or more of the interventional devices are packaged together as a single unit in an assembled (e.g., nested or stacked) configuration may provide efficient unpackaging and preparation prior to use and efficient assembly within a robotic control system. The interventional devices may be pre-mounted to their respective hubs prior to packaging. In certain embodiments, two or three or more interventional devices may be packaged in a fully nested (i.e., fully axially inserted) configuration or nearly fully nested configuration. In a fully nested configuration, each interventional device is inserted as far as possible into an adjacent distal hub and interventional device. Such a fully nested configuration may minimize a total length of the interventional device assembly and minimize the size of the packaging required to house the interventional device assembly.
In some embodiments, the interventional devices may also be sterilized prior to packaging while in the assembled configuration, for example, using ethylene oxide gas. In some embodiments, the interventional devices may be packaged while in the assembled configuration before sterilization with ethylene oxide gas. For interventional devices in a nested or stacked configuration, ethylene oxide gas can be provided in a space between adjacent interventional devices (for example, an annular lumen between an outer diameter of a first interventional device nested within a second interventional device and the inner diameter of the second interventional device) for sterilization. In some embodiments, the interventional device assembly can be packaged in a thermoformed tray and sealed with an HDPE (e.g., Tyvek®) lid. The interventional device assembly can be unpackaged by removal (e.g., opening or peeling off) of the lid by a user in a sterile field. A user in the sterile field can then remove the interventional device assembly and place it on the sterile work surface, for example, of a robotic drive table, as described herein.
Packaging the interventional devices in an assembled configuration and sterilized state can reduce the time associated with unpackaging and assembly of individual interventional devices and facilitate efficient connection to a robotic drive system. Each interventional device and hub combination may further be packaged with a fluidics connection for coupling to a fluid source, or one or more fluid sources, and/or a vacuum source. In some embodiments, each hub, or a hemostasis valve coupled to the hub, may include the fluidics connection.
After the interventional device assembly is unpackaged (e.g., after the interventional device assembly is positioned on the robotic drive table), priming can be performed while the devices are concentrically nested or stacked. This is preferably accomplished in each catheter lumen, for example, the annular lumen between the guide catheter 2906 and the procedure catheter 2904, and in between each of the additional concentric interventional devices in the catheter stack. In certain embodiments, fluid can be introduced in one or more lumens of the catheter stack to prime one or more interventional devices. For example, fluid can be introduced in a lumen between a distal hub and a proximal interventional device. For example, the lumen between the hub 2914 and the catheter 2904. In certain embodiments, priming can be performed while the devices are in the sterile packaging. More typically, priming of one of more of the catheters in the catheter stack can be performed when the catheter assembly has been removed from its packaging.
The fluidics connections of the catheter assembly (for example, the fluidics connection to one or more of the hubs) can be connected to a fluidics system for delivering saline and contrast media to the catheters, and providing aspiration. In some embodiments, one or more of the fluidics connections (e.g., to saline, contrast, or aspiration) may extend from the sterile field to outside the sterile field for connection to the fluidics system. Once connected, the fluidics system can perform a priming sequence to flush each catheter of the interventional device assembly with fluid (e.g., saline, contrast media, or a mixture of saline and contrast media). The priming sequence may also include flushing each corresponding catheter hub with fluid. The fluid may be de-aired or de-gassed by the fluidics system prior to priming. In some embodiments, a vacuum source of the fluidics system can also be used to evacuate air from each catheter while flushing with fluid. In certain embodiments, a tip of the catheter can be placed into a container of fluid, such as saline, contrast media, or a mixture of saline and contrast media, during priming so that the fluid in the container, and not air, is aspirated through the tip of the catheter when the vacuum source is applied. In other embodiments, the tip of the catheter may be blocked (for example, using a plug) so that air is not aspirated from the tip of the catheter when the vacuum source is applied. In certain embodiments, the priming process may be automated such that a user can provide a single command and each catheter (and in some embodiments, each corresponding catheter hub) can be primed, sequentially (for example, as described with respect to
Additional details regarding fluidics systems are disclosed in U.S. patent application Ser. No. 17/879,614, entitled Multi Catheter System With Integrated Fluidics Management, filed Aug. 2, 2022, which is appended hereto (Appendix A) and hereby expressly incorporated in its entirety herein.
Fluid resistance within a lumen may be greater when there is a reduction in cross sectional luminal area for flow, for example, when a second interventional device (e.g., a catheter or guidewire) extends within the lumen of a first interventional device. The amount of fluid resistance can be affected by the length of the cross sectional narrowing, for example, due to a depth of axial insertion of the second interventional device within the first interventional device. A second interventional device extending partially through the lumen of a first interventional device will provide a smaller length of cross-sectional narrowing, and accordingly may result in a lower fluid resistance within the lumen of the first catheter, than if the second interventional device were to extend entirely through the lumen of the first interventional device. Thus, fluid resistance can be lowered by at least partially decreasing a depth of axial insertion (i.e., axial overlap) of a second interventional device into the lumen through which fluid is to be injected (e.g., a length of the second interventional device into its concentrically adjacent lumen).
In some embodiments, over certain depths of insertion of a second interventional device within a first interventional device (for example, when the second interventional device is at or near a maximum insertion depth within the first interventional device), the size of the fluid channel between the devices (e.g., the annular lumen between the first interventional device and the second interventional device) can lead to higher than desirable amounts of fluid resistance during a priming procedure. In some embodiments, the depth of insertion of the second interventional device within the first interventional device can be decreased to reduce the pressure needed to prime the catheter and reduce internal interference.
In some embodiments, a catheter in the interventional device assembly can be separated from the other interventional devices for priming to reduce the pressure needed to prime the catheter and reduce internal interference. The catheter being primed may be separated from the interventional devices within the lumen of the catheter by proximally retracting the interventional devices within the lumen of the catheter. For example, the interventional devices within the lumen of the catheter being primed can be proximally retracted from the catheter being primed as far as possible while still maintaining a nested or stacked relationship (e.g., at least about 2 cm or 5 cm or more axial overlap) in order to minimize the pressure needed to prime the catheter and minimize internal interference. In other words, a catheter can be separated from more proximal interventional devices for priming while a distal tip of an adjacent proximal interventional device is still positioned within the lumen of the catheter. Maintaining at least some of the distal tip of an adjacent proximal interventional device within the lumen of the catheter may allow for easier reinsertion and advancement of the proximal interventional device after priming.
In some embodiments, the axial overlap may be between about 2 cm and about 20 cm, between about 2 cm and 10 cm, between about 2 cm and 5 cm, between about 5 cm and 20 cm, between about 5 cm and 10 cm, or any other suitable range. In some embodiments, the axial overlap may be at least about 2 cm, at least about 5 cm, at least about 10 cm, at least about 20 cm, no more than 2 cm, no more than 5 cm, no more than 10 cm, no more than 20 cm, about 2 cm, about 5 cm, about 10 cm, about 20 cm, or any other suitable amount. For example, in some embodiments the axial overlap may be about 2 cm, 3 cm, 4 cm, 5 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm, 18 cm, 19 cm, or 20 cm, plus or minus ½ cm.
In some embodiments, the robotic drive table can be programed to proximally retract the inner interventional device(s) from the catheter being primed as much as possible while still maintaining a nested or stacked relationship. In other embodiments, the robotic drive table can be programmed to separate inner devices from the catheter being primed to a distance sufficient to optimize the length of the unobstructed lumen and result in an amount of fluid resistance lower than a threshold value. After the catheter being primed is separated from the other interventional devices, the catheter can be primed by flushing the catheter with fluid, such as saline, contrast media, or a mixture of saline and contrast media.
After the catheter is primed, it may be returned to an initial position and a next catheter of the interventional device assembly can be separated from the other interventional devices within its lumen for priming. This sequence can be repeated for each catheter of the interventional device assembly. In other embodiments, after a catheter is primed, it may be advanced to a ready or drive position to begin insertion into the patient. While the foregoing describes separating catheters to be primed by retraction of inner interventional devices, an outer catheter may also be separated from inner interventional devices by distally axially advancing the outer catheter relative to the inner interventional devices. An example of a priming process is described with respect to
After the catheter 2906 is primed and returned to its initial position, the catheter 2904 and hub 2912 can be distally axially advanced relative to the catheter 2902, hub 2910, guidewire 2907 and hub 2909 (also distally axially advancing the catheter 2906 and hub 2914 without changing or minimally changing their relative position with respect to catheter 2904), for example, as far as possible while maintaining a distal tip of the catheter 2902 within the lumen of the catheter 2904, as shown in
After the catheter 2904 is primed and returned to its initial position, the catheter 2902 and hub 2910 can be distally axially advanced relative to the guidewire 2907 and hub 2909 (also distally axially advancing the catheter 2906, hub 2914, catheter 2904, and hub 2912 without changing or minimally changing their relative positions with respect to the catheter 2902), for example, as far as possible while maintaining a distal tip of the guidewire 2907 within the lumen of the catheter 2902, or to a distance that will result in a desirable amount of fluid resistance for priming. In some embodiments, the catheter 2902, the catheter 2904, and the catheter 2906 are advanced in response to a control signal from a control system. The catheter 2902 can then be primed by introducing priming fluid using the fluidics system. In some embodiments, priming fluid is introduced in response to a control signal from a control system. Priming the catheter 2902 can include priming the hub 2910. For example, in certain embodiments, the hub 2910 or a hemostasis valve coupled thereto can include fluidics connections to receive priming fluid from the fluidics system. After priming, the catheter 2902 and catheters 2904 and 2906 can be returned to their initial positions (e.g., the fully axially compressed configuration) shown in
In some embodiments, the priming procedure described with respect to
In alternative embodiments, each of the catheters can be distally separated from one another simultaneously for priming. For example, the catheter 2902 can be distally separated from the guidewire 2907 while maintaining the distal tip of the guidewire 2907 in the lumen of the catheter 2902, the catheter 2904 can be distally separated from the catheter 2902 while maintaining the distal tip of the catheter 2902 in the lumen of the catheter 2904, and the catheter 2906 can be distally separated from the catheter 2904 while maintaining the distal tip of the catheter 2904 in the lumen of the catheter 2906 simultaneously. However, an embodiment in which only one set of adjacent hubs is separated at a time, as described with respect to
In alternative embodiments, one or more of the catheter 2902, the catheter 2904, and the catheter 2906 can be advanced to a ready or drive position to begin insertion into the patient after priming (e.g., prior to priming a subsequent catheter). In such embodiments, the catheters may advance to the ready or drive position without returning to their initial position after priming.
As described above, in some embodiments, the catheters 2902, 2904, and 2906 may be assembled into the concentric stack orientation illustrated in
While fluid is being introduced under pressure into the proximal end of the annular lumen (e.g., into a hub of the outer catheter or a hemostasis valve coupled thereto), the inner catheter may be moved with respect to the outer catheter, to disrupt the holding forces between the microbubbles and adjacent wall and allow the bubbles to be carried downstream and out through the distal opening of the lumen or removed via aspiration. The catheters may be moved axially, rotationally or both with respect to each other. In certain embodiments, the catheters may be reciprocated axially, rotationally, or both with respect to each other. In some embodiments, the catheters may be moved intermittently axially, rotationally, or both. In other embodiments, the catheters may be rotated continuously or in a constant direction. In some embodiments, the catheters are moved using a driving mechanism that moves the catheter hubs, for example, a magnetically coupled drive system
In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as axially over a stroke length in a range of from about 1 mm to about 250 mm, from about 10 mm to about 250 mm, from about 5 mm to about 125 mm, from about 25 mm to about 125 mm, from about 10 mm to about 50 mm, from about 15 mm to about 30 mm, from about 5 mm to about 30 mm, from about 15 mm to about 25 mm, from about 20 mm to about 40 mm, or any other suitable range. In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as axially over a stroke length of at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 50 mm, no more than 10 mm, no more than 20 mm, no more than 25 mm, no more than 30 mm, no more than 50 mm, no more tan 125 mm, no more than 150 mm, about 5 mm, about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 50 mm, or any other suitable stroke length.
In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as axially at a reciprocation frequency in a range of from about 0.5 Hz to about 1 Hz, from about 1 Hz to about 5 Hz, from about 1 Hz to about 10 Hz, from about 1 Hz to about 25 Hz, from about 5 Hz to about 10 Hz, from about 10 Hz to about 25 Hz, or any other suitable range of frequencies. In some implementations, the first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as axially at a reciprocation frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz or any other suitable frequency.
In one implementation, a first catheter is moved reciprocally with respect to the adjacent catheter or guidewire such as axially over a stroke length in a range of from about 0.5 inches to about 10 inches, or from about one inch to about 5 inches at a reciprocation frequency of no more than about 5 cycles per second or two cycles per second or less.
In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as rotationally over an angle of rotation per stroke in a range of from about 5 degrees to about 180 degrees, from about 5 degrees to about 360 degrees, from about 15 degrees to about 180 degrees, from about 15 degrees to about 150 degrees, from about 15 degrees to about 120 degrees, from about 15 degrees to about 90 degrees, form about 15 degrees to about 60 degrees, from about 15 degrees to about 30 degrees, from about 30 degrees to about 180 degrees, from about 30 degrees to about 150 degrees, from about 30 degrees to about 120 degrees, from about 30 degrees to about 90 degrees, form about 30 degrees to about 60 degrees, from about 60 degrees to about 180 degrees, from about 60 degrees to about 150 degrees, from about 60 degrees to about 120 degrees, from about 60 degrees to about 90 degrees, from about 90 degrees to about 180 degrees, from about 90 degrees to about 150 degrees, from about 90 degrees to about 120 degrees, from about 120 degrees to about 180 degrees, from about 120 degrees to about 150 degrees, from about 150 degrees to about 180 degrees or any other suitable range. In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as rotationally over an angle of rotation per stroke of at least 5 degrees, at least 15 degrees, at least 30 degrees, at least 60 degrees, at least 90 degrees, at least 120 degrees, at least 150 degrees, at least 180 degrees, at least 360 degrees, no more than 5 degrees, no more than 15 degrees, no more than 30 degrees, no more than 60 degrees, no more than 90 degrees, no more than 120 degrees, no more than 150 degrees, no more than 180 degrees, no more than 360 degrees, about 5 degrees, about 15 degrees, about 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees, about 150 degrees, about 180 degrees, about 360 degrees, or any other suitable angle.
In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as rotationally at a reciprocation frequency in a range of from about 0.5 Hz to about 1 Hz, from about 1 Hz to about 5 Hz, from about 1 Hz to about 10 Hz, from about 1 Hz to about 25 Hz, from about 5 Hz to about 10 Hz, from about 10 Hz to about 25 Hz, or any other suitable range of frequencies. In some implementations, the first catheter is moved reciprocally with respect to an adjacent catheter or guidewire such as rotationally at a reciprocation frequency of at least 0.5 Hz, at least 1 Hz, at least 2 Hz, at least 5 Hz, at least 10 Hz, at least 25 Hz, no more than 0.5 Hz, no more than 1 Hz, no more than 2 Hz, no more than 5 Hz, no more than 10 Hz, no more than 25 Hz, about 0.5 Hz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 25 Hz or any other suitable frequency.
In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire for a number of reciprocations between 1 and 200, between 1 and 100, between 1 and 50, between 1 and 25, between 1 and 15, between 1 and 10, between 1 and 5, between 5 and 25, between 5 and 15, between 5 and 10, or any other suitable range. In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire for at least 1 reciprocation, at least 2 reciprocations, at least 5 reciprocations, at least 10 reciprocations, at least 15 reciprocations, at least 25 reciprocations, at least 50 reciprocations, no more than 5 reciprocations, no more than 10 reciprocations, no more than 15 reciprocations, no more than 25 reciprocations, no more 50 than reciprocations, no more than 100 reciprocations, no more than 200 reciprocations, about 1 reciprocation, about 2 reciprocations, about 5 reciprocations, about 10 reciprocations, about 25 reciprocations, about 50 reciprocations, about 100 reciprocations, about 200 reciprocations, or any other suitable number. One reciprocation can include a movement (axially or rotationally) from a first position to a second position followed by a return from the second position to the first position.
In some implementations, a first catheter is moved reciprocally or rotationally with respect to an adjacent catheter or guidewire over a length of time in a range of from 1 about second to about 60 seconds, from about 1 second to about 45 seconds, from about 1 second to about 30 seconds, from about 1 second to about 20 seconds, from about 1 second to about 15 seconds, from about 1 second to about 10 seconds, from about 5 seconds to about 45 seconds, from about 5 seconds to about 30 seconds, from about 5 seconds to about 20 seconds, from about 5 seconds to about 15 seconds, from about 5 seconds to about 10 seconds, from about 10 seconds to about 30 seconds, form about 10 seconds to about 20 seconds, or any other suitable range. In some implementations, a first catheter is moved reciprocally with respect to an adjacent catheter or guidewire over a length of time of at least 1 second, at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, no more than 5 seconds, no more than 10 seconds, no more than 15 seconds, no more than 20 seconds, no more than 30 seconds, no more than 45 seconds, no more than 60 seconds, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 30 seconds, about 45 seconds, about 60 seconds, or any other suitable length of time.
Reciprocation of adjacent catheters to disrupt microbubbles may be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally with respect to each other while delivering pressurized fluid (e.g., saline, contrast media, or a mixture of saline and contrast media). Alternatively, such as in a robotically driven system, a processor may be configured to robotically drive at least one of two adjacent catheter hubs (for example, at least one of hub 2914 and hub 2912) to achieve relative movement between the adjacent catheters thereby disrupting and expelling microbubbles, such as in response to user activation of a flush control. For example, in certain embodiments, two adjacent interventional devices may be moved relative to one another in response to a control signal from a control system. In certain embodiments, delivery of pressurized fluid may be performed in response to a control signal from a control system.
The reciprocation of adjacent catheters may generate shear forces that dislodge the air bubbles. For example, relative movement of the inner and outer surfaces of adjacent catheters may increase the fluid shear rate between the adjacent catheters during priming in comparison to static surfaces. In some embodiments, the shear force can be increased by increasing the flow rate of the solution (e.g., saline, contrast media, or a mixture of saline and contrast media) being provided by the fluidics system. In certain embodiments, both flow rate and relative movement between adjacent catheters are controlled to dislodge air bubbles.
In some embodiments, after each catheter is primed by the fluidics system, an ultrasound bubble detector may be used to confirm that the catheters are substantially free of air bubbles. For example, an ultrasound chip (such as mounted within a hub adjacent a catheter receiving lumen) may be run along the length of the catheters to confirm that no air bubbles remain in the system.
An example of a priming process including reciprocal movement of adjacent catheters is described with respect to
A priming sequence may begin by priming the catheter 2906. In some embodiments, the catheter 2906 can be primed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2906 while generating reciprocal movement of catheter 2906 and/or hub 2914, axially, rotationally or both, relative to the catheter 2904. Priming the catheter 2906 can include priming the hub 2914. For example, in certain embodiments, the hub 2914 or a hemostasis valve coupled thereto can include fluidics connections to receive priming fluid from the fluidics system. In certain embodiments, the catheter 2906 and/or hub 2914 can be axially agitated back and forth along a longitudinal axis of the catheter 2906 (e.g., between the position of
In some embodiments, priming of the catheter 2906 may be performed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2906 while generating reciprocal movement of the catheter 2904 and/or hub 2912, axially, rotationally, or both, relative to the catheter 2906. Axial and/or rotational reciprocal motion of the catheter 2904 and/or hub 2912 can be performed manually or by a robotic drive table. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, priming of the catheter 2906 may be performed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2906 while generating reciprocal movement of both the catheter 2906 (and/or hub 2914) and the catheter 2904 (and/or hub 2912), axially, rotationally, or both, relative to one another. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, after priming the catheter 2906, the catheter 2906 can be returned to an initial position as shown in
In some embodiments, after the catheter 2906 is primed, the catheter 2904 can be primed. Priming the catheter 2904 can include priming the hub 2912. For example, in certain embodiments, the hub 2912 or a hemostasis valve coupled thereto can include fluidics connections to receive priming fluid from the fluidics system. In some embodiments, the catheter 2904 can be primed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2904 while generating reciprocal movement of the catheter 2904 and/or hub 2912, axially, rotationally or both, relative to the catheter 2902. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, priming of the catheter 2904 may be performed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2904 while generating reciprocal movement of the catheter 2902 and/or hub 2910, axially, rotationally, or both, relative to the catheter 2904. Axial and/or rotational reciprocal motion of the catheter 2902 and/or hub 2910 can be performed manually or by a robotic drive table. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, priming of the catheter 2904 may be performed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2904 while generating reciprocal movement of both the catheter 2904 (and/or hub 2912) and the catheter 2902 (and/or hub 2910), axially, rotationally, or both, relative to one another. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, after priming the catheter 2904, the catheter 2904 can be returned to an initial position as shown in
In some embodiments, after the catheter 2904 is primed, the catheter 2902 can be primed. Priming the catheter 2902 can include priming the hub 2910. For example, in certain embodiments, the hub 2910 or a hemostasis valve, a three-way valve, or other fluid control valve coupled thereto can include fluidics connections to receive priming fluid from the fluidics system. In some embodiments, the catheter 2902 can be primed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2902 while generating reciprocal movement of the catheter 2902 and/or hub 2910, axially, rotationally or both, relative to the guidewire 2907. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, priming of the catheter 2902 may be performed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2902 while generating reciprocal movement of the guidewire 2907 and/or hub 2909, axially, rotationally or both, relative to the catheter 2902. Axial and/or rotational reciprocal motion of the guidewire 2907 and/or hub 2909 can be performed manually or by a robotic drive table. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, priming of the catheter 2902 may be performed by introducing fluid (e.g., saline, contrast media, or a mixture of saline and contrast media) under pressure into the lumen of the catheter 2902 while generating reciprocal movement of both the catheter 2902 (and/or hub 2910) and the guidewire 2907 (and/or hub 2909), axially, rotationally or both, relative to one another. Reciprocal movement may be generated in response to a control signal from a control system. Introducing fluid under pressure may be performed in response to a control signal from a control system.
In some embodiments, after priming the catheter 2902, the catheter 2902 can be returned to an initial position as shown in
In some embodiments, the priming procedure described with respect to
In the priming sequence described herein with respect to
In certain embodiments, priming the catheters can include decreasing a depth of axial insertion (i.e., axial overlap) of a second interventional device into the lumen of a first interventional device through which fluid is to be injected (e.g., a length of the second interventional device into its concentrically adjacent lumen), as described with respect to
In some embodiments, the fluid source and/or sink 2612 includes both a reservoir of fluid volume and a means of propelling such fluid to another component of the system 2600 or a means of retrieving fluid back to the source. Example propelling means may include one or more propellers, impellers, syringes, and/or pumps to circulate and/or retrieve fluid throughout system 2600. In some embodiments, the propelling means can be used to control the volume, flow rate, and/or pressure. In certain embodiments, the propelling means can be activated to propel fluid to another component of the system or retrieve fluid from the system or deactivated to stop the movement of fluid.
In some embodiments, the fluidics management channel is substantially duplicated for each catheter configured for use in a particular medical procedure. Different channels may differ in sensors, pumps, and/or valves employed based on the interventional device that is connected to each fluidics channel. For example, a fluidics system for a procedure catheter (e.g., for aspiration) may include an inline vacuum pump and filter. Further for example, a fluidics system for a guide, access, or insert catheter may include an inline drip rate sensor, air bubble sensor, pressure sensor, and/or air bubble filter.
The source and/or sink 2612 represents either a fluid source or a fluid sink (e.g., waste canister). For example, a fluid source may include a container adapted to house a fluid (e.g., saline, contrast, pharmaceuticals, blood, plasma, or other fluid) for use with the fluidics management system 2600. The container may be configured to release fluid into a fluid delivery line (e.g., fluid delivery tube) using active means (e.g., pumps, vacuums, etc.) or passive (e.g., gravity). The fluid sink may include a container adapted to receive fluids (e.g., aspirate, thrombus, particulate, saline, contrast, pharmaceuticals, blood, or other fluid or combination thereof) from the patient and/or from other fluidics infrastructure within the fluidics management system 2600.
The valve 2614 represents one or more valves that are coupled to the source and/or sink 2612 at a first side of the valve 2614 and coupled to the manifold 2616 at a second side of the valve 2614. The manifold 2616 is configured to connect each valve 2614 to a particular hub 2618. In some embodiments, the valve 2614 may instead couple directly to the hub 2618 to avoid the use of a separate manifold 2616. In some embodiments, the manifold 2616 may be integrated into the hub. In some embodiments, a second valve 2614 may connect the manifold 2616 to the hub 2618. For example, the second valve 2614 can be coupled to the manifold 2616 at a first side and coupled to the hub 2618 at the second side.
The hub 2618 is configured to releasably or non-releasably couple to an interventional device (catheter, guidewire, guiding element, or other medical device). For example, a catheter 120 has a proximal end attached to a unique hub 2618, sometimes referred to as a “puck.” In some embodiments, the hub 2618 is moveable along a path along the surface of a robotic drive table to advance or retract the catheter 120 (or other medical and/or interventional device). Each hub 2618 may also contain mechanisms to rotate or deflect the catheter 120 or guidewire as desired. The hub 2618 may be connected to fluid delivery tubes (e.g., source/sink line 2116) to provide fluid release or fluid capture. Each hub 2618 may be in electrical communication with an electronic control system, either via hard wired connection, RF wireless connection, or a combination of both. Additional details of the hubs, drive table and related systems are found in U.S. patent application Ser. No. 17/816,669, entitled Method of Supra-Aortic Access for a Neurovascular Procedure, filed Aug. 1, 2022, which is hereby expressly incorporated in its entirety herein.
Any of the hubs disclosed herein may further comprise one or more fluid injection ports and/or a wireless RF transceiver for communications and/or power transfer. In some embodiments, the hub 2618 may also comprise a wired electrical communications port and a power port.
In some embodiments, the hub 2618 or line 2116 leading to the hub 2618 may include a visual indicator, for indicating the presence of an aspirated clot. The visual indicator may comprise a clot chamber having a transparent window. A filter may be provided in the clot chamber. Additional details of the clot capture filter and related features may be found in U.S. Provisional Patent Application Ser. No. 63/256,743, entitled Device for Clot Retrieval, filed Oct. 18, 2021, which is hereby expressly incorporated in its entirety herein.
Any of the hubs or interventional devices disclosed herein may further comprise a sensor for detecting a parameter of interest such as a location or orientation of a distal tip or a status of the distal tip of an interventional device. The status of the distal tip may include, but not be limited to: detection of an interaction between a vessel wall and the distal tip, detection of an interaction between a vessel wall and a clot, or detection of an unobstructed distal tip. The sensor, in some instances, may be positioned on a flexible body of an interventional device. The sensor may comprise a pressure sensor to capture arterial blood pressure waveform at the distal end of the catheter, or an optical sensor to determine captured clot or air bubbles. In some embodiments, the sensor may comprise one or more of: a force sensor, a positioning sensor, a temperature sensor, a torque sensor, a strain sensor, and/or an oxygen sensor. In some embodiments, the sensor may comprise a Fiber Bragg grating sensor. For example, a Fiber Bragg grating sensor (e.g., an optical fiber) may detect strain locally that can facilitate the detection and/or determination of force being applied.
In certain embodiments, the first source 2612a can be a source of heparinized saline. The source 2612b can be a source of contrast solution. In certain embodiments, one or more of the source 2612a, the source 2612b, and the source 2612c can couple to a plurality of manifolds 2616, each coupled to a unique interventional device 2618.
The valve manifold 2616 as shown herein may be utilized in any of the systems described herein.
The components of fluid management portion 2702 may be located outside of the sterile field or within the sterile field. In some embodiments, the fluid management portion 2702 is located outside of the sterile field, but is coupled to the interventional portion 2704, which is located within the sterile field, by flexible tubing and flexible electrical conductors.
The fluid management portion 2702 may include at least two or three or more channels (e.g., parallel channels) of the type shown in
Each of the two or more fluid channels may be primed by completely degassing and filling with a respective fluid in order to be ready for transport into the catheter and into the bodily lumen. In some embodiments, fluid lines, catheters, and/or catheter lumens can be simultaneously flushed and primed with a fluid (e.g., saline).
In some embodiments, the systems 2700, 2800 may be configured to backfill each sink connection to each catheter with fluid (e.g., saline) at procedure initialization and/or between fluidics step. This may provide a backfilled column of saline downstream of the sink connection, for example, to ensure that contrast injections flow to a distal tip of a particular catheter rather than to the sink. In some embodiments, the systems 2600, 2700 may be configured to provide a backfilled column of saline upstream of a saline valve at the hub, for example, to ensure that contrast injections flow to the distal tip of a particular catheter or the sink rather than through the saline valve.
As shown in
A number of valves (and/or valve arrays) are provided to stop and start flow of each respective fluid to or through one or more fluid lines, and/or hubs within the portions 2702 and/or 2704. In the illustrated implementation, a first valve array 2716a (e.g., with three valves) is carried by a first manifold 2718a, a second valve array 2716b (e.g., with three valves) is carried by a second manifold 2718b, and a third valve array 2716c (e.g., with three valves) is carried by a third manifold 2718c. Although valve arrays with three valves are shown, any number of valves are possible and may correspond to the number of catheters and/or fluid sources being used in the procedure or a subset of the interventional devices being used in the procedure. For example, in some situations, each valve array may include at least one valve, two valves, three valves, or four or more valves.
In some embodiments, each valve in a valve array (e.g., valve array 2716a) may be configured to independently control and/or adjust fluid resistance, flow rate, and/or pressure of fluid flowing through the valve and corresponding tubing. In some embodiments, each valve in a valve array can be independently and/or simultaneously adjusted for a respective catheter and/or for more than one catheter.
In the illustrated implementation, the fluidics channel is duplicated for each catheter and will therefore be described only in connection with source 2710a below. A first outflow valve 2717a is in communication with a first catheter 2726 by a unique source line 2720a. A second outflow valve 2717b is in communication with a second catheter 2728 by a unique source line 2720b. A third outflow valve 2717c is in communication with a third catheter 2730 by a unique source line 2720c. Each valve 2717a-2717c is preferably electronically actuated in response to signals from the control system, between a fully closed, fully open, or partially open positions. Any of a variety of valve mechanisms maybe utilized, such as a ball valve driven by a stepper motor, solenoid, a stopcock valve (e.g., a rotating stopcock valve), a rotary valve, or other drive mechanism known in the art. The drive mechanisms may provide for automated control and sequencing of the valves. For example, valve actuation may be achieved using stepper motors with in-built encoding to provide consistent switching and sequencing. The drive mechanisms may be controlled using motor controllers of a user control interface (for example, or a computer system). The control system may include modules that read values from sensors (e.g., flow, bubble, pressure, etc.) and display the values to control the behavior of the fluid system.
In some embodiments, a stopcock valve mechanism (e.g., a rotating stopcock valve) may be used in the manifolds described herein. For example, one or more stopcock valves may be placed adjacent to (or integrated into) a hub to avoid management of a column of fluid in particular tubing. Such tubing may be sterile disposable tubing that may offer a one time use. Placing a manifold with stop cock valves near or integrated into the hub has the advantage of simplicity without the need to manage a column of fluid in the tubing. Having the manifold and stopcock valves away from the hub(s) may allow the manifold and the stopcock valves to both be used outside of a sterile field in conjunction with non-sterile equipment. Such a configuration may provide an advantage of preserving sterility of the components in the sterile field.
In some embodiments, the fluidics control system may further include a drive mechanism configured to adjust the sealing strength of the hemostatic valve in response to a signal from the control system, for example, from a processor of the control system. The control system (e.g., the processor) may be configured to increase the sealing strength of the hemostatic valve in response to the manipulation of the contrast control to introduce contrast into the catheter. The control system (e.g., the processor) may additionally be configured to decrease the scaling strength of the hemostatic valve in response to the manipulation of the contrast control to stop introducing contrast into the catheter. In some embodiments, the control system (e.g., the processor) may be configured to decrease the sealing strength of the hemostatic valve in response to a signal received to drive a catheter or guidewire through the hemostatic valve. Such a feature may provide the advantage of reducing friction between the hemostatic valve and a moving catheter shaft, for example.
In operation, all three valves 2717a-2717c maybe in an open configuration to flow saline through each of the three catheters. Forward flow (in the direction of arrow 2722a) of saline may be driven by a pump 2714 such as an electronically controlled peristaltic infusion pump or a rotary piston pump. Alternatively, any one of the valves may be open with the other two closed depending upon the desired performance. Alternatively or additionally, other sources of volume and/or pressure (for example, pump 2714) can be deactivated or disconnected to prevent flow.
In the concentric catheter stack illustrated in
The available lumen in the first catheter 2726 is the difference between the inner diameter (ID) of first catheter 126 and the outer diameter (OD) of second catheter 2728. That may be different than the available lumen in the second catheter 2728 (which may be the difference between the ID of second catheter 2728 and the OD of third catheter 130), which may be different than the available lumen of the third catheter 2739 (which may be the ID of the third catheter 2730 or the difference between the ID of the third catheter 130 and the OD of the guidewire 2732). In order to produce the same delivered infusion flow rate through each of the catheters, the control system may be configured to adjust the pump 2714 and/or each of the valves 2717a-2717c to compensate for differences in the effective cross sections of each respective flow path in order to achieve the same delivered flow rate through each catheter. The system can use parameter files associated with the attached devices (catheters and guidewire), the parameter files having dimension information (e.g., ID's, OD, length) of the devices. The system can adjust a pump based on the dimension information as well as information relating to the fluid being communicated inside the catheter (e.g., the density and/or the viscosity of contrast media being communicated through a catheter lumen).
In one implementation of the invention, the catheters may be assembled into the concentric stack orientation illustrated in
While saline is being introduced under pressure into the proximal end of the annular lumen between two interventional devices (for example, the annular lumen between the first catheter 2726 and the second catheter 2728), the inner catheter may be moved with respect to the outer catheter (for example, the second catheter 2728 may be moved with respect to the outer catheter), to disrupt the holding forces between the microbubbles and adjacent wall and allow the bubbles to be carried downstream and out through the distal opening of the lumen. The catheters may be moved axially, rotationally or both with respect to each other. In one implementation, a first catheter is moved reciprocally with respect to the adjacent catheter or guidewire, such as axially through a range of from about 0.5 inches to about 10 inches, or from about 1 inch to about 5 inches at a reciprocation frequency of no more than about 5 cycles per second or two cycles per second or less.
Reciprocation of adjacent catheters to disrupt microbubbles may be accomplished manually by grasping the corresponding catheter hubs and manually moving the catheters axially or rotationally with respect to each other while delivering pressurized saline. Alternatively, such as in a robotically driven system, a processor maybe configured to robotically drive at least one hub of two adjacent catheters (for example, at least one of hub 2724a and hub 2724b) to achieve relative movement between the adjacent catheters thereby disrupting and expelling microbubbles, such as in response to user activation of a flush control.
The source 2710b is in fluid communication with manifold 2718b, allowing fluid to flow as shown by arrow 2722b to any number of valves (e.g., three) within valve array 2716b. Forward flow (in the direction of arrow 2722b) of contrast may be driven by a pump 2736 such as a syringe pump, high pressure positive displacement pump, contrast injection pump, etc. Any one of the valves of the valve array 2716b may be open with the other two closed depending upon the desired performance. Alternatively or additionally, other sources of volume and/or pressure (for example, pump 2736) can be deactivated or disconnected to prevent flow. A proximal opening of each source line 2721a, 2721b, 2721c may be coupled to a respective output port on the corresponding valve within the valve array 2716b. A distal opening of each source line 2721a, 2721b, 2721c may be coupled to each respective hub 124a, 2724b, 2724c, and thus to the corresponding catheter 2726, catheter 2728, and/or catheter 2730. The respective catheter 2726, catheter 2728, catheter 2730, and/or guidewire 2732 may be guided into a patient (not shown). Additional hubs and/or catheters may be added to system 2700 and corresponding fluidics management system components (e.g., system 2600) may be added to system 2700. In other embodiments, the system 2700 may include less hubs and/or catheters, for example two hubs and/or catheters.
The sink 2712 is coupled to a manifold 2718c to receive fluid from aspiration lines 2723a, 2723b, 2723c in the direction shown by arrow 2722c. The aspiration lines are configured to receive fluid and embolic material from one or two or all three respective catheters 126, 128 and 130 depending upon input from the physician into the control system. Once the physician has determined which catheter(s) will be placed into aspiration mode, and actuated the corresponding aspiration control(s) the corresponding valve(s) within the valve array 2716c may be opened to allow the fluid to flow through the corresponding catheter and into the sink 2712, in response to the control system activating an aspiration pump 2715. Any one of the valves of the valve array 2716c may be open with the other two closed depending upon the desired performance. Alternatively or additionally, other sources of volume and/or pressure (for example, pump 2715) can be deactivated or disconnected to prevent flow.
In an example embodiment, the fluidics system 2700 represents an aspiration configuration in which the source 2710a contains heparinized saline and the source 2710b contains contrast solution. The sink 2712 in this example may contain waste blood/saline/embolic material that has been aspirated from a patient (not shown). Other additional sources and/or sinks may be used in combination with respective fluids.
Similarly, the contrast solution contained by source 2710b may flow in the direction of arrow 2722b and may flow into manifold 2718b. In a given procedure, the physician may determine to inject contrast through any of the three catheters, and typically through the most distal catheter at a given injection time. In response to an inject contrast command, the control system will open the valve corresponding to the selected catheter and typically maintain the other two valves closed. In some embodiments, the physician may inject contrast concurrently into two or more catheters. In some embodiments, for example, while driving catheters or guidewires, contrast or aspiration may be applied concurrently.
In some embodiments, each valve (or valve array) can be housed inside or carried by a respective hub 2724a, 2724b, 2724c. In some embodiments, each valve (or valve array) may be housed adjacent to or remote from a respective hub. In such examples, additional fluid lines (e.g., 2720, 2721, 2723) may be added between each manifold and a corresponding valve. The fluid lines 2720a-c, 2721a-c, and 2723a-c may be tubes. In some embodiments, any of the fluid lines 2720a-c, 2721a-c, and 2723a-c may be removably coupled to their respective hubs. Alternatively, any of the fluid lines 2720a-c, 2721a-c, and 2723a-c may be inseparably connected to the hubs and removably coupled to other components of the fluid management portion 2702, such as the valve arrays 2716a-c or manifolds 2718a-c.
In some embodiments, the fluidics system 2700 may also include any number of pressure sensors, volume sensors, flow rate sensors, tubing sets, connectors, bubble sensors/detectors as will be discussed. In the illustrated implementation a pressure transducer 2734a is in pressure sensing communication with the first catheter 2726 by way of hub 2724a. Additional pressure transducers 2734b, 2734c may be placed in communication with their corresponding catheters as illustrated.
The control system may be configured to automatically adjust the various manifold valves, pumps and hemostatic valves (discussed below) in response to commands input by the physician. For example, a physician might input a command to infuse contrast through the third catheter 2730. The control system may cause a series of responsive events to automatically occur. At least the saline valve 2717c would close. Valves 2717a and 2717b may be closed or may remain open to provide positive pressure through the first and second catheters, to prevent backflow of contrast.
A control signal will be sent to a hemostasis valve in each of the first catheter hub 2724a and second catheter hub 2724b, to clamp down from a low pressure sliding fit to a high pressure clamp around the second catheter 2728 and third catheter 2730 respectively. This will prevent contrast from escaping proximally through the first catheter 2726 and second catheter 2728. A control signal will additionally be sent to valve 2719c to place the third catheter 2730 in fluid communication with the second source 2710b containing contrast solution.
If the space between the OD of the guidewire 2732 and the ID of the third catheter 2730 is insufficient to allow a desired contrast infusion rate, a further signal will be sent from the control system to the drive system controlling hub 2724d, to proximally retract the guidewire 2732 from the third catheter 2730 a distance sufficient to allow the flow of contrast through catheter 2730. An additional control signal may be sent to a hemostasis valve carried by hub 2724c to clamp in a high pressure mode around a distal portion of the guidewire 2732 or to clamp into a completely closed configuration if the guidewire 2732 was fully retracted. A further control signal may be sent to an electronically activated high pressure pump 2736 such as a syringe pump, high pressure positive displacement pump, contrast injection pump, etc., to deliver contrast solution through the third catheter 2730.
If the physician initiates a command to perform aspiration through, for example, the first catheter 2726, the control system may automatically transmit another series of control signals to execute the command. Signals will be sent to each of the hemostasis valves to move them from the high pressure configuration to the low pressure configuration in which there is less friction generated against a shaft of the catheter or guidewire. Such a configuration may permit relative movement of the various devices and proximal retraction of the second catheter 2728 and third catheter 2730 from first catheter 2726 while still inhibiting proximal blood loss through the hemostasis valves. Signals will be sent to the drive system to proximally retract each of the hubs 2724b, 2724c and 2724d. Valve 2723a will be opened to place the first catheter 2726 into fluid communication with the sink 2712. A signal will be sent to actuate the vacuum pump 2715, thereby aspirating blood and thrombus into the sink 2712. In some embodiments, when performing aspiration of the first catheter 2726, for example, communication between the catheter 2726 and the first fluid source 2710a and the second fluid source 2710b may be obstructed. For example, the corresponding valves of the valve arrays 2716a and 2716b may be closed to obstruct the manifolds 2718a and 2718b. Alternatively, the sources of volume and/or pressure (for example, pumps 2714 and 2736) may be deactivated or disconnected.
All of the fluid lines between the first source 2710a and second source 2710b and each of the catheters, and all of the fluid lines between sink 2712 and each of the catheters are preferably completely flushed free of any bubbles and filled with a fluid such as saline during system preparation before the procedure. This allows seamless transition between infusion, aspiration and manipulation of the catheters and guidewire without the need to disconnect and reconnect any fluid lines between the sources, sink and catheters, eliminating the risk of introducing air emboli during such exchanges.
It may also be desirable to enable confirmation of the absence of bubbles in any of the fluid lines. This may be accomplished placing bubble sensors in bubble sensing proximity to each of the fluid lines, such as in or upstream of each of the hubs, or at the manifolds. This may be particularly desirable in a telemedicine application, where the physician is at a remote work station, and out of direct line of sight from the patient.
This may be accomplished using a non-contact ultrasonic sensor that measures the intensity and doppler shift of the reflected ultrasound through the sidewall of fluid tubing to detect bubbles and measure fluid flow rate or fluid level. An ultrasonic or optical sensor may be positioned adjacent an incoming fluid flow path within the hub, or in a supply line leading to the hub.
For example, to detect the presence of air bubbles in the infusion line (that is formed of ultrasonically or optically transmissive material) the sensor may include a signal source on a first side of the flow path and a receiver on a second side of the flow path to measure transmission through the liquid passing through the tube to detect bubbles. Alternatively, a reflected ultrasound signal may be detected from the same side of the flow path as the source due to the relatively high echogenicity of bubbles.
Alternatively, an optical sensor may be provided to detect changes in optical transmission or reflection due to the presence of bubbles, or to transmit a visual signal to a display at the remote work station where the physician can visually observe the presence of a bubble moving through the tubing. In a system having a bubble detector, the control system can be configured to automatically shut down all fluid flow in response to the detection of a bubble to give personnel an opportunity to plan next steps.
In one implementation, a bubble removal system is automatically activated upon detection of in line bubbles. A processor may be configured to activate a valve positioned in the flow path downstream of the bubble detector, upon the detection of bubbles. The valve diverts a column of fluid containing the detected bubble out of the flow path leading to the patient and instead into a bypass flow path or reservoir. Once bubbles are no longer detected in the flow path and after the volume of fluid in the flow path between the detector and the valve has passed through the valve, the valve may be activated to reconnect the source of fluid with the patient through the flow path. In some embodiments, the flow path may include any number of bubble filters and/or traps to remove bubbles from the flow path.
The robotic system portion 2704 may include a drive table that is configured to receive (e.g., be coupled to) any number of hubs (2724a, 2724b, 2724c, 2724d, etc.). Additional details of the hubs, drive table and related systems are found in U.S. patent application Ser. No. 17/816,669, entitled Method of Supra-Aortic Access for a Neurovascular Procedure, filed Aug. 1, 2022, which is hereby expressly incorporated in its entirety herein. Each hub is configured to be coupled to a catheter, or guidewire, one or more fluidics lines, one or more electrical lines, one or more controls, and/or one or more displays. For example, a drive table may be positioned over or alongside the patient, and configured to support axial advancement, retraction, and in some cases rotation and/or lateral deflection of two or three or more different (e.g., concentrically or side by side oriented) devices (e.g., catheters, guidewires, etc.).
The drive system independently drives movement of each hub independently in a proximal or distal direction across the surface of the table to move the corresponding interventional device (e.g., catheter 2726, catheter 2728, catheter 2730, and/or guidewire 2732) proximally or distally within the patient's vasculature.
The respective catheter 2726, catheter 2728, catheter 2730, and/or guidewire 2732 may be guided into a bodily lumen (not shown) as a single concentric catheter stack, in response to movement of the respective hubs 2724a, 2724b and 2724c as discussed elsewhere herein. The system 2700 may also include a guidewire hub 2724d for controlling the guidewire 2732, which may also be introduced into a bodily lumen along with one or more of catheter 2726, catheter 2728, and/or catheter 2730.
In some embodiments, a driven magnet is provided on each hub. Each driven magnet is configured to cooperate with a drive magnet associated with the table such that the driven magnet(s) move in response to movement of the drive magnet(s). In such examples, the drive magnet(s) may be axially movably carried by the support table.
Because multiple sources and/or sinks are configured to each be coupled (and remain coupled) to each catheter hub (e.g., hubs 2724a, 2724b, and 2724c), the fluidics system 2700 provides the advantage of enabling faster procedures than conventional fluidics systems that utilize manual removal, addition, and/or switching of fluids, catheters, hubs, and the like during the procedure. For example, the fluidics system 2700 enables each fluid line/catheter hub to be connected to each source fluid and/or sink before beginning a procedure. When the interventionalist (or other medical practitioner) performing the procedure is ready to use a particular source fluid or sink, the system 2700 is already configured and ready to allow use of the particular source fluid or sink without having to switch between different fluid lines for particular catheters. In some embodiments, the system 2700 may be used to provide a method of treatment in which fluid sources need not be connected to and/or disconnected from a medical device more than once during a procedure.
Thus, the interventionalist can inject any of the fluids contained in fluid sources 2710a, 2710b and/or collect aspirate from any of the catheters 2726, 2728, and/or 2730 at any point during the procedure because each catheter hub 2724a, 2724b, 2724c is provided access to all fluid lines at all times.
Because the multiple sources that are indicated for a particular procedure are preconfigured to be connected to each catheter/catheter hub, an interventionalist (or other medical practitioner) may be assured that there is no repetitive connecting and disconnecting of syringes or other source fluid containers, fluid lines, etc. during the procedure. This assurance removes the possibility of introducing bubbles into the catheter flow during the procedure because no connecting or disconnecting of fluid sources are needed with the use of system 2700. Instead, each fluid source and sink are connected and tested before the procedure and are not removed until after the procedure is completed. In some embodiments, the constant connection of fluid sources and sinks to catheter hubs associated with operation of system 2700 removes the variability and risk in remote procedures where the interventionalist is in a control room rather than the procedure room.
The valves within valve arrays 2716a, 2716b, and or 2716c of system 2700 are depicted at the respective manifolds 2718a, 118b, and 118c. In such a configuration the valves are near the respective source and/or sinks with about two meters to about three meters (e.g., about six to about ten feet) of fluid line between the valves of valve arrays 2716a, 2716b, and 2716c and the respective catheter hubs 2724a, 2724b, and 2724c. In some embodiments, the valves of valve arrays 2716a, 2716b, and/or 2716c may instead be located at the sources/sinks (e.g., 2710a, 2710b, and/or 2712). In some embodiments, the valve arrays 2716a, 2716b, and/or 2716c are coupled to the fluid lines at a location between the source/sink and the hubs. In some embodiments, the valve arrays 2716a, 2716b, and/or 2716c may be located at the catheter hubs 2724a, 2724b, and/or 2724c. In some embodiments, valves that are located at or near the hubs may be disposable valves. Other components of systems 2700, 2800 may also be disposable and/or re-processable for reuse.
In some embodiments, the system 2800 may additionally include valves 2713a-2713i between the valve arrays 2716a, 2716b, and 2716c and the respective hubs 2724a, 2724b, and 2724c. The valves 2713a-c can be part of a valve manifold (for example, such as the valve manifold 2616 of
Each hub 2724a, 2724b and 2724c may be provided with a hemostasis valve to accommodate introduction of another device therethrough, as illustrated in
The gasket may be actuatable between a first, fully open state; a second partially open state for scaling against low pressure fluid injections from the first fluid source or the second fluid source through a first port (as described herein), for permitting fluid to flow through the first port to the sink, while allowing advancing or retracting an interventional device; and a third tightly closed state for resisting backflow of high pressure fluid (e.g. contrast media) injections from the second fluid source through the first port or for permitting fluid flow through the first port to the sink. The gasket may be manually actuatable or automatically actuatable, for example based on a user input corresponding to manipulation of one or more of the interventional devices of the system.
As shown in
An air bubble filter 2804 may be provided in line between a needle injection port 2806 and catheter 2826. The system 2800 further includes a line branch point 2808 (e.g., a wye) in fluid communication with a first source 2810a and a second source 2810b. The line branch point 2808 may include luer lock connectors or wye connector that interfaces with multiple fluid sources.
The system 2800 may also include a pump such as a peristaltic pump 2834 or rotary piston pump that drives fluid under pressure from the second source 2810b to the line branch point 2808 in the direction of arrow 2822c.
An air bubble sensor may be provided on an upstream or downstream side of the pump 2834. The air bubble sensors 2836a, 2836b may be non-contact ultrasonic sensors that measure an intensity and doppler shift of a reflected ultrasound through a sidewall of fluid tubing to detect bubbles and measure fluid flow rates or fluid levels as has been discussed. In some embodiments, the sensor 2836a may also be a pressure sensor or a separate pressure sensor may be provided.
A valve 2816c such as a ball valve or rotary valve can selectively open or close fluid communication between the second source 2810b and the catheter 2826. A flow rate detector such as a drip rate sensor 2838 enables determination and display of the flow rate from second source 2810b.
Fluid flow from the first source 2810a is directed through a one way check valve 2814 and on to a high pressure pump 2852, which may be a syringe pump, high pressure positive displacement pump, contrast injection pump, etc. High pressure fluid (e.g., contrast solution) is directed through an air bubble sensor 2836a and on to branch point 2808 through valve 2816b. Arrows 2822b indicate the direction of fluid flow.
Resistance to fluid flow through different catheters in a concentric catheter stack differs based upon the available lumen cross sectional area. For example, resistance measurements within an inner catheter with a fully open lumen (e.g., with guidewire removed) may be lower than resistance measurements within an outer catheter having a second catheter (or a guidewire) extending therethrough. Therefore, when performing saline flushing steps, the fluidics system 2800 may be configured to ensure a similar flow rate or a procedure appropriate flow rate through each inner and outer catheter to avoid clotting or other issues within the catheters. To do so, a valve may be adjusted for each catheter to ensure the flow rate remains constant amongst all catheters during saline flushing. The system 2800 may determine such flow rates in real time based on flow rate sensors, and the control system may be configured to automatically adjust valve settings and/or pump parameters to maintain the desired flow rate through each catheter.
In some embodiments, fluid resistance may be altered by adjusting an insertion length of each shaft into its concentrically adjacent lumen. As described herein, fluid resistance within a lumen may be greater when there is a reduction in cross sectional luminal area for flow, for example, when a second catheter (or a guidewire) extends into the lumen. The amount of fluid resistance can be affected by the length of the cross sectional narrowing, for example, due to placement of the second catheter (or guidewire) within the lumen. A second catheter (or guidewire) extending partially through the lumen of a first catheter will provide a smaller length of cross-sectional narrowing, and accordingly may result in a lower fluid resistance within the lumen of the first catheter, than if the second catheter (or guidewire) were to extend entirely through the lumen of the first catheter. Thus, fluid resistance can be lowered by partially retracting a depth of insertion of a second catheter (or guidewire) into the lumen through which fluid is to be injected.
The system 2800 further includes an aspiration canister 2840 coupled to an upstream side of filter 2844. A downstream side of the filter 2844 is coupled to a vacuum pump 2842. The aspiration canister 2840 is connected to a valve 2816a, which may be in communication with a sterile field clot capture container 2802 which has been discussed elsewhere herein. Arrow 2822a indicates the direction of fluid flow.
An optional pressure sensor 2846 is depicted on a proximal end of a catheter 2826 or hub coupled to a hemostatic valve, such as a rotating hemostatic valve (RHV) 2848.
In this example, the RHV 2848 is connected to two different fluid sources. The RHV 2848 may be carried by and at least partially disposed in a hub (e.g., hub 124a of
The RHV 2848 may be configured to enable a catheter or other instrument to be introduced into the body of a living being while precluding unintended back bleeding. In some embodiments, each RHV described herein may be configured with at least a fully closed configuration, a low sealing force state in which devices may be advanced therethrough without leaking, and a high sealing force state (e.g., mode) which prevents escape of fluids under high pressure and may prevent axial movement of devices therethrough.
The RHV 2848 is configured to be concurrently and fluidly connected to a first fluid source (e.g., source 2810a) via the first fluid source connection (e.g., valve 2816b). The RHV 2848 is further configured to be concurrently and fluidly connected to a second fluid source (e.g., source 2810b) via the second fluid source connection (e.g., valve 2816c). In addition, the RHV 2848 is further configured to be concurrently and fluidly connected to the sink (e.g., aspiration canister 2840) via the sink connection (e.g., valve 2816a).
In operation, the system 2800 is configured to automatically switch between introducing fluid into a lumen of the elongate body (e.g., catheter 2826) through the RHV 2848 from the first fluid source (e.g., source 2810a) or from the second fluid source (e.g., source 2810b) or to permit fluid removal from the lumen to be collected in the sink (e.g., aspiration canister/sink 2840).
In some embodiments, the optional pressure sensor 2846 is located at either the upstream side or downstream side of the RHV 2848 (as shown in
For example, if the catheter is misaligned against a vessel wall, then the detected pressure (e.g., waveform) may be blunted. Such a detection may be provided to an algorithm performed by a processor associated with system 2800, for example, to determine the patency of the lumen of the catheter of the patency of the catheter distal tip. Such a pressure sensor and algorithm may provide an improved alternative to conventional determinations of pressure where manual operation of fluidics is occurring and an interventionalist may retract (e.g., pull back) on a syringe coupled to the catheter to verify that blood capture occurs and to assess tactile feedback of the catheter.
Such blood capture and tactile feedback assessments may indicate patency of the lumen or distal tip before an injection or aspiration is performed. However, the pressure sensor 2846 may provide for an automated and improved way to assess lumen or distal tip patency. That is, the addition of a pressure sensor 2846 (e.g., a blood pressure sensor) on the proximal end of a catheter may capture an arterial pressure waveform. The waveform can be used to determine whether the catheter distal tip is pressed against a vessel wall, the catheter tip is pressed against a thrombus, the catheter tip has full patency, or the catheter lumen is in a clogged or fully patent state, without having direct visual or tactile feedback. In some embodiments, the waveform can be used to determine a state of engagement of the catheter distal tip against the clot and/or a consistency of the clot.
In some embodiments, the fluidics systems (e.g., system 2700, system 2800) described herein include a hemostasis valve (e.g., RHV 2848) that includes a first three-way connector having a first fluid source connection (e.g., one-way valve 2716a, 2816b), a second fluid source connection (e.g., one-way valve 2716b, 2816c) and a sink connection (e.g., one-way valve 2816a).
In some embodiments, the fluidics systems described herein (e.g., system 2700, system 2800) utilize a first fluid source that comprises one of saline, heparinized saline, or a pharmaceutical. In some embodiments, the second fluid source (e.g., source 2710b, 2810b) comprises contrast.
The systems 2700, 2800 may further include a second hemostasis valve that is in communication with and may be at least partially disposed in the second hub (e.g., 2724b). The second hemostasis valve may include a third fluid source connection (e.g., valve 2716b), a fourth fluid source connection (valve 2716b), and a second sink connection (e.g., valves 2716c). In this example, the first manifold 2718a may include a second output line that is configured to connect to a third fluid source connection (not shown).
The cassette 3141 may be a self-contained unit comprising a housing having a plurality of valves, tubing and connectors as described below. A first connector array comprises a plurality of releasable connectors such as luer connectors, for placing the cassette in fluid communication with complementary connectors in fluid communication with sources of aspiration and at least one or two or more fluids. A second connector array is configured for releasable connection to a tubing set configured to extend between the cassette and at least one or two or three interventional devices.
The cassette 3141 thus forms a bridge module that when assembled resides between the various fluid and vacuum sources, and the corresponding interventional devices. The cassette 3141 may be configured for a single use, or may be re-sterilizable and reusable.
As shown in
Fluid flow from the syringe pump is directed into a cassette 3141, which may include a plurality of valves, manifolds, and/or connectors. Within the cassette 3141, the fluid flow may split along a plurality of branches 3118b to a plurality of connectors 3117b (for example, four connectors 3117b as shown in
Fluid flow from the second fluid source 3110b may be directed into a plurality of branches 3118c to a plurality of pumps 3134c (for example, four pumps 3134c as shown in
The system further includes an aspiration canister 3140 in communication with an upstream side of a filter 3144. A downstream side of the filter 3144 is in communication with a vacuum pump 3142. The aspiration canister receives fluid from the cassette 3141 which includes a plurality of connectors 3117a each being configured to couple to a unique interventional device. A unique valve 3116a (at least two, and four in the illustrated example) may be positioned upstream of each connector 3117a. Each unique valve 3116a may be positioned along a branch 3118a.
In certain embodiments, one or more connector arrays 3146 may be arranged, each connector array 3146 configured to couple an interventional device. For example, a connector array 3146 is indicated by dashed lines in
The connector array 3146 can releasably couple to a tubing set 3143 including an aspiration tube 3154, a first fluid tube 3155, and a second fluid tube 3156. In some embodiments, the connectors 3117a, 3117b, and 3117c can be luer lock connectors. The aspiration tube 3154 can couple to the connector 3117b of the array 3146 by way of a complementary connector 3117d for aspiration from the interventional device to the aspiration container. The first fluid tube 3155 can couple to the connector 3117b of the array 3146 by way of a complementary connector 3117e to provide fluid flow from the first fluid source 3110a to the interventional device. The second fluid tube 3156 can couple to the connector 3117c of the array 3146 by way of a complementary connector 3117f to provide fluid flow from the second fluid source 3110b to the interventional device. The tubes 3154, 3155, and 3156 may be joined together over a majority of their lengths. The tubes 3154, 3155, and 3156 can each have a length of at least about three or four feet, and in certain embodiments between about 6 feet and about 8 feet.
As shown in
In certain embodiments, the system 3100 (or other systems described herein) can direct the flow of the second fluid (for example, saline) using two different flow modes. In a low flow drip mode, a flow rate of about 1-2 drips per second or 3-6 mL/min may be provided, for example, by the pumps 3134. In some embodiments, a low flow mode rate of 1-8 mL/min may be provided. Each catheter coupled to the system may experience a different fluid resistance as described herein.
The pumps, for example pumps 3134, can be operated to provide the same flow rate in each catheter. In certain embodiments the fluid pressure within the catheter can be at least about 330 mmHg or 6.5 psi. This pressure may be enough to overcome arterial pressure while delivering the desired drip rate. In certain embodiments, the pressure within the catheter can be greater than 330 mmHg. In certain embodiments, the delivered fluid volume can be at least about 1 liter over the length of a procedure. In some embodiments, the fluid volume can be up to 2 liters.
In a high flow flush mode, all of the fluid lines may be flushed to remove air. The flow rate can be between 100-1000 mL/min. The fluid pressure may be between 5-10 psi. The volume delivered can be between 0.5-1 liters per procedure. Volume may depend on tubing length and diameter. In some embodiments, the high flush flow rate is at least about 20 times and in some cases between 30 to 150 times the low flow drip mode flow rate.
In certain embodiments, the first fluid (for example, contrast solution) can be provided at a flow rate of between 3-8 L/s (for example, about 4 mL/s), for example, by the pump 3152. In certain embodiments, the flow rate can be up to about 8 mL/s. In other embodiments, the flow rate can be up to about 20 mL/s. In certain embodiments, the first fluid can be provided with a pressure of about 400 psi for a flow rate of about 4 mL/s. The amount of pressure needed may depend on flow rate and flow restriction of the fluid path. The pressure may increase proportionally with the flow rate for higher flow rates. In certain embodiments, the pressure may be up to 1200 psi.
In certain embodiments, the high pressure pump, such as pump 3152, can provide a delivered volume of between 5-15 mL per high pressure injection. In certain embodiments, the pump can provide the 5-15 mL per high pressure injection in increments of about 1 mL per puff. In certain embodiments, the second fluid source can provide a total volume of about 200 mL per procedure. In certain embodiments, the syringe pump is sized to hold at least about 150 mL or 200 mL so as to provide uninterrupted flow throughout the procedure without the need to add additional contrast solution. In other embodiments, the second fluid source can provide a total volume of between 150-250 mL per procedure.
In certain embodiments, the flow rate may vary depending upon the anatomical location at the distal end of the catheter. For example, within the aortic arch, the flow rate may be about 20 mL/s. A total delivered volume of about 25 mL may be infused in the aortic arch. Within the common carotid artery, the flow rate may be about 20 mL/s. A total delivered volume of 12 mL may be infused in the common carotid artery. Within the subclavian artery, the flow rate may be about 6 mL/s. A total delivered volume of about 15 mL may be infused in the subclavian artery. Within the internal carotid artery, the flow rate may be about 6 mL/s. A total delivered volume of about 8 mL may be infused in the internal carotid artery. Within the external carotid artery, the flow rate may be about 3 mL/s. A total delivered volume of about 6 mL may be infused in the external carotid artery. Within the vertebral artery, the flow rate may be about 6 mL/s. A total delivered volume of 8 mL may be infused in the vertebral artery.
In certain embodiments, a motor may be provided to drive the high pressure pump, such as pump 3152, which can be controlled with a position and velocity control loop using a potentiometer as a measurement to close the loop. In certain embodiments, current control may be applied to provide approximate pressure limiting. In certain embodiments, the second fluid can be a contrast solution such as Omnipaque 300, Omnipaque 350, or Visipaque 320.
In certain embodiments, a vacuum pump, such as pump 3142, can provide a pressure of about −29.5 inHg or up to −29.5 inHg (−999 mbar). In certain embodiments, tubing used for aspiration can have an inner diameter of 0.11 inches (about 2.8 mm). In certain embodiments, the volume of the aspiration container, such as container 3140, can be at least about 0.5 L. In certain embodiments, the volume of the aspiration container can include about 0.5 L for blood and additional volume for a saline flush. In certain embodiments, the aspiration container can have a volume between 0.25-0.75 L. In certain embodiments, the vacuum pump can be configured to operate to additionally provide a low pressure/flow setting to assist a flushing process as it may be desirable that an aspiration line is full of saline at all times (except when aspirating a clot). In certain embodiments, a separate pump may be provided for the low pressure/flow setting.
In some embodiments, the cassette 3204 and the pump station 3202 include corresponding electrical contacts or connections (both referred to as “contacts”) that are connected when the cassette 3204 is coupled to the pump station 3202 to connect electrical components (e.g., sensors) in the cassette 3204 to the pump station 3202. The electrical contacts may include contacts for providing information from a component in the cassette (or the hub coupled to the cassette) to a controller in the pump station or a controller in communication with the pump station that is configured to operate the fluidics system, or another system that utilizes such information. The electrical contacts may include contacts for providing power to a component in the cassette. In some embodiments, the electrical contacts can also electrically connect the pump station 3202 to one or more hubs 3224 via the cassette 3204. Accordingly, the electrical contacts can provide power to a component in a one or more hubs via the cassette (and via electrical connections between the cassette and the one or more hubs). Certain components of the system 3200 can be configured to be disposable and certain components can be configured to be reusable. For example, the one or more hubs 3224 and catheters coupled to the hubs, a tubing set 3216, and/or cassette 3204 can be configured to be disposable. Valves related to controlling providing fluids and providing vacuum in system 3200 can be referred to collectively as a “valve assembly” for ease of reference. The valve assembly can include, but is not limited to, valves in a saline subsystem 3206, contrast subsystem 3208, and vacuum subsystem 3210 that are located in a pump station 3202, cassette 3204, and/or the one or more hubs 3224. As described in examples below, the system 3200 provides saline, contrast, and vacuum, from saline, contrast, and vacuum sources (respectively) through fluid communication channels to the one or more hubs 3224 and catheters coupled to the hubs 3224. The fluid communication channels can include channels, tubes, ports, lines connectors, and other structure to communicate fluid and provide vacuum. Unless otherwise indicated “channels,” “tubes,” and “lines” may be used synonymously herein as referring to a fluid communication channel. For example, the fluid communication channels can include channels in the cassette 3204, one or more tubes that are part of tubing set 3216, and tubes and/or channels located in a hub 3224, and the fluid communication channels can be collectively referred to as a fluid communication system.
Embodiments of a saline subsystem 3206, a contrast subsystem 3208, and a vacuum subsystem 3210 that can be used to perform methods for controlling fluid administration equipment are illustrated in
As indicated above, an example of a fluidics system 3200 configured to provide saline, contrast, and vacuum to the one or more hubs 3224 and provide saline to a femoral sheath 3226 is illustrated in
In various embodiments, the fluidics system 3200 illustrated in
In this example, the fluidics system 3200 includes a saline subsystem 3206, a contrast subsystem 3208, and a vacuum subsystem 3210. In some embodiments, the vacuum subsystem 3210 may be a vacuum/aspiration (“V/A” or simply “vacuum”) subsystem. An example of a saline subsystem 3206 is illustrated in
Also, the contrast subsystem 3208, or a portion thereof, can be in the cassette 3204. For example, a contrast syringe pump, or a portion thereof, can be located in the cassette 3204, and the cassette 3204 may include a contrast port to receive contrast from a contrast container positioned outside of the cassette 3204. Pump station 3202 may include an air column detector configured to detect air in a fluid communication channel (e.g., a tube) between the contrast container and the syringe pump.
Further, the vacuum subsystem 3210, or a portion thereof, can be included in the cassette 3204, and a portion of the vacuum subsystem can be included in the pump station. For example, a vacuum canister and vacuum control valves can be in the cassette 3204, and a vacuum pump and actuators for the vacuum control valves can be located in the pump station 3202. As another example, the cassette 3204 may also include a vacuum port for coupling to a vacuum source of the pump station. Other configurations where certain components of the saline subsystem 3206, the contrast subsystem 3208, and the vacuum subsystem 3210 are located in the pump station 3202, and other components of the saline subsystem 3206, the contrast subsystem 3208, and the vacuum subsystem 3210 are located in the cassette 3204, are also possible.
The saline, contrast, and vacuum ports are part of a fluid communication system which includes fluid communication channels (e.g., channels, tubes, lines, etc.) to couple the catheters to the saline source, contrast source, and vacuum source. The cassette 3204 includes a portion of the fluid communication system that is couplable to the saline, contrast, and vacuum source, and valves in the cassette partially control fluid flowing through channels of the fluid communication system in the cassette. The fluid communication system also includes a tubing set 3216. The tubing set 3216 can include fluid communication channels for communicating saline, contrast, and/or vacuum to hubs 3224a-3224c and/or saline to the femoral sheath 3226. In this example, the tubing set 3216 includes saline tubes 3218, contrast tubes 3219, and vacuum tubes 3220. In preferred embodiments, the tubing set includes flexible tubes for providing saline, contrast and vacuum to the hubs. For example, tubes that may be 4′ to 10′ long, according to some embodiments. As illustrated in the embodiment of
Each of the hubs 3224a-3224c (also referred to herein as a “hub assembly”) may include a plurality of components related to providing saline, contrast, and vacuum to a catheter, and components related to moving the hub and an interventional device attached thereto in an axial direction and rotating the catheter. The tubing set 3216 can also include electrical connections to communicate control information to the one or more hubs 3224 and/or receive information from components of the hubs 3224a-3224c (e.g., sensor information). A proximal end 3234 of the tubing set 3216 may be coupled to the cassette 3204, and a distal end 3232 of the tubing set 3216 may be coupled to the hubs 3224a-3224c and the femoral sheath 3226. In the illustrated example, each of the hubs 3224a-3224c is coupled to the cassette 3204 by an electrical channel 3217, a saline tube 3218, a contrast tube 3219, and a vacuum tube 3220. An example of fluidic components in an embodiment of a hub is illustrated in
In the illustrated embodiment, a saline/contrast valve 3266 is included in line 3264c. The saline/contrast valve 3266 can be moved to be in a first position of a second position by a saline/contrast valve actuator 3267, which may be in the pump station 3202. The saline/contrast valve 3266 is configured such that when it is placed in a first position (shown in
The contrast pump 3310 includes a housing 3311 that encloses a contrast chamber 3313 which receives contrast from the contrast container 3302. The contrast pump 3310 includes a wall or movable portion 3312 that can be moved to increase or decrease the size of the contrast chamber 3313. The movable portion 3312 is coupled to a movable member 3314, which can be moved by a linear contrast pump actuator 3315 which includes a motor.
In some embodiments, the contrast intake valve actuator 3308, the contrast pump actuator 3315, and the air column detector 3306 (run-out sensor) can be located in the pump station 3202, and the contrast intake valve 3307 (between the connection 3304 and the contrast pump 3310), the contrast pump 3310, contrast control valves 3322a, 3322b, 3322c (hereinafter “contrast control valves 3322a-3322c”), and the lines and components that communicate contrast to ports C1, C2, C3 can be located in the cassette 3204, as shown in
Contrast is provided from the contrast pump 3310 to a contrast manifold 3318 by line 3316. The contrast manifold 3318 provides a fluid communication channel to contrast ports C1, C2, and C3 via lines 3320a, 3320b, 3320c (hereinafter “lines 3320a-3320c”), contrast control valves 3322a-3322c, and lines 3326a, 3326b, 3326c (hereinafter “lines 3326a-3326c”). Contrast valve actuators 3324a, 3324b, 3324c (hereinafter “actuators 3324a-3324c”) are coupled to the contrast control valves 3322a-3322c when the cassette 3204 is coupled to the pump station 3202, and are controlled by the system controller 3800 to open and close the contrast control valves 3322a-3322c for performing preparation processes (e.g., priming) or for performing a medical procedure (e.g., injecting contrast). Line 3270 is a fluid communication channel connected to the saline subsystem 3206 connection and allows saline to flow from the saline subsystem 3206 to the contrast manifold 3318 as controlled by the saline/contrast valve 3266.
The vacuum manifold 3375 can be coupled to lines 3379a, 3379b, 3379c (hereinafter “lines 3279a-3379c”) and lines 3378a, 3378b, 3378c (hereinafter “lines 3378a-3378c”) which provide a vacuum channel to hubs/catheters via ports V1-V3. Vacuum control valves 3374a, 3374b, 3374c (hereinafter “vacuum control valves 3374a-3374c”) may be one-way valves and are coupled between lines 3379a-33879c and lines 3378a-3378c to control providing vacuum to ports V1-V3, and the vacuum control valves 3374a-3374c are opened and closed by vacuum control valve actuators 3276a, 876b. 876c (hereinafter “vacuum control valve actuators 3276a-876c”) of the pump station 3202, vacuum control valve actuators 3376a-3376c being controlled by a controller. To provide vacuum to one or more of the ports V1-V3, and hubs and catheters coupled to ports V1-V3, a controller opens the vacuum control valve 3374a-3374c corresponding to the desired port, actuates the vacuum pump 3388, and controls the vacuum regulator 3390 and vacuum regulator valve 3377 to produce the desired vacuum and monitors the vacuum being provided by using the vacuum pressure sensor 3371. Some embodiments can include a flow sensor 3380 that is associated with each port V1-V3 and/or a vacuum pressure sensor 3371 that is associated with each port V1-V3. However, in most procedures, vacuum is provided to one catheter at a time and in such cases multiple flow sensors and pressure sensors do not provide any operational advantage, and having a single flow sensor 3380 and a single vacuum pressure sensor 3371 positioned upstream of the vacuum manifold 3375, as shown in
As illustrated in
In some embodiments, the three-way valve 3423 can be a three-way stopcock. The three-way valve 3423 may be actuated (e.g., rotated) to selectively provide or prevent fluid communication between ports coupled to the saline/contrast tube 3440, the aspiration tube 3435, and the catheter coupling tube 3433. The three-way valve 3423 can be actuated to a first position to open a fluid communication channel between the aspiration tube 3435 and the catheter coupling tube 3433 and a second position to open a fluid communication channel between the saline/contrast tube 3440 and the catheter coupling tube 3433. In some embodiments, the three-way valve 3423 can be actuated to third position in which the aspiration tube 3435, the saline/contrast tube 3440, and the catheter coupling tube 3433 are all in fluid communication. In some embodiments, the three-way valve can be actuated to a fourth position in which the vacuum tube 3435 and the saline/contrast tube 3440 are in fluid communication. In some embodiments, the three-way valve 3423 can be actuated to a fifth position in which none of the aspiration tube 3435, the saline/contrast tube 3440, and the catheter coupling tube 3433 are in fluid communication.
While a three-way valve 3423 is shown in
As shown in
A hemodynamic pressure sensor 3429 may be positioned between the three-way valve 3423 and the catheter 3430, for example, on the catheter coupling tube 3433. The hemodynamic pressure sensor 3429 is configured to sense a hemodynamic pressure of a patient in which the catheter 3430 is inserted, and provide information relating to the sensed pressure to a controller.
The interface 3735 can also be configured to communicate information to the remotely located control system 3710. The communicated information can be related to a received control action, fluidic information, catheter position information, status information, images or video, audio and other communications from the robotic system or users located locally with the patient, and any other information that may be needed to control the robotic catheter system from the control system 3710. The interface 3735 can also be configured to receive inputs from users of the robotic catheter system located with the patient.
The system controller 3800 can include pump station 3740 for performing fluidic-related actions, and a controller 3720 configured for processing user inputs received locally or from the control system 3710, and processing sensor information, and controlling the pump station 3740 and other portion of the robotic control system to perform medical procedures based on the user inputs and the sensed information, including providing saline, contrast, and vacuum to hubs 3224a-3224c, and saline to the femoral sheath, as needed during a medical procedure.
The robotic catheter system illustrated in
A cassette configured to be releasably attached to the pump station can include all or part of the saline subsystem 3206, the contrast subsystem 3208, and the vacuum subsystem 3210. A determination of what is disposable may be based on contact or near contact with patient materials (cells, blood, removed clots, etc.). In some embodiments, the cassette and its components is disposable, and the pump station 3202 and its components are non-disposable (e.g., capital equipment). In an example of a saline subsystem 3206, a pump station 3202 can include saline weight sensor 3250 and a saline drip rate sensor 3259, peristaltic pumps actuators 763a-763d, and a saline/contrast valve actuator 3267, and a cassette 3204 can include a saline level detector 3245, peristaltic pumps 762a-762d, and a saline/contrast valve 3266 (
In
The fluidics system also can include channels and components in the one or more hubs 3224. For example, as illustrated in the embodiments of
In
After executing any of actions represented in blocks 4095, 4096, 4097, the process can proceed back to block 4091 where the system determines if a good hemodynamic waveform exists. If after the system performs one of the actions represented in blocks 4095, 4096, 4097, and a good hemodynamic waveform still does not exist, the system can proceed to another of actions represented in blocks 4095, 4096, 4097, perform that action to proceed back to block 4091 and again determine if a good hemodynamic waveform exists. During this process, the system can provide status, to a remotely located control system 3710 and/or on an interface of the local system controller 3800, indicating an action that has taken. In some embodiments, the system receives input from a user indicating which of the actions represented in blocks 4095, 4096, 4097, or another action, to perform in order to ensure the catheter tip is clear. In some embodiments, the system determines which of the actions represented in blocks 4095, 4096, 4097, or another action, to perform, for example, based on historical data, system information, physician's preference, patient information, or other information. After the system determines a good hemodynamic waveform exists, the process can move to block 4092 with the system determine/verify if it is armed and ready to inject contrast. For example, if the contrast pump 3310 is ready to inject contrast. After the system determines it is armed, the process proceeds to block 4093 where it determines if the catheter is back-bled and/or primed. If not, the process proceeds to block 4094 with the system back-bleeds the selected catheter. After the system determines that the catheter has been back-bled or primed, the process proceeds to block 4098 where contrast injection can continue, and the process proceeds to the seventh block 3982 in
At the seventh block 3982 the system determines if a catheter has been selected for injecting contrast. If a catheter has been selected, the process proceeds to block 3984 where a user (e.g., physician) initiates contrast injection. If a catheter has not been selected, the process proceeds to block 3983 where a catheter is selected for injecting contrast, for example, based on a user input.
The contrast injection process proceeds to block 3985 where the system can determine if the selected catheter volume is greater than a certain predetermined amount (for example, if the volume of the catheter is greater than 2 ml) based on system information. In some instances, the system determines the volume of the selected catheter based at least partially on whether the lumen of selected catheter contains another catheter, or a guidewire, which the system may determine based on information relating to the position of the hubs when contrast injection is being performed. If the volume of the selected catheter is not greater than the predetermined amount, at block 3986 the system injects contrast, for example, up to a requested volume.
If the catheter volume is greater than the predetermined amount, at block 3987 the system injects contrast, for example, up to a requested amount.
Referring again to
Additional embodiments are disclosed in further detail in the following examples, which are not in any way intended to limit the scope of the claims
In a first example, the syringe 2102 (
In a second example, the syringe 2102 (
In a third example, an outer catheter having a inner diameter of about 0.071 inches and an inner catheter having an inner diameter of about 0.035 inches were used in the test system 2100 (
In certain embodiments, the control system 4000 can include one or more processors 4002. The one or more processors 4002 can be configured to automatically adjust the various system components described herein in response to commands input by an operator, for example, using one or more controls 4004 of the control system 4000. A single control 4004 is shown in
In certain embodiments, one or more controls 4004 may control priming functions for one or more interventional devices. For example, one or more controls 4004 can be operated to cause the interventional devices to perform a priming procedure, as described for example, with reference to
In certain embodiments, one or more controls 4004 may be operated to cause the interventional devices to perform a priming procedure, as described for example, with reference to
The processor 4002 may receive signals from the one or more controls 4004 and in response, initiate corresponding actions in the components of the systems described herein. For example, the processor 4002 may be configured to generate output signals that cause responsive actions to be performed by the components of the described herein.
While the foregoing describes robotically driven interventional devices and manually driven interventional devices, the devices may be manually driven, robotically driven, or any combination of manually and robotically driven interventional devices, as will be appreciated by those of skill in the art in view of the disclosure herein.
The foregoing represents one specific implementation of a robotic control system. A wide variety of different robotic control system constructions can be made, for supporting and axially advancing and retracting two or three or four or more assemblies to robotically drive interventional devices, as will be appreciated by those of skill in the art in view of the disclosure herein.
As explained above in connection to
Various trials were performed using trial procedure 4400 to demonstrate the effect of various variables including catheter length, guidewire diameter, guidewire coating, programmed injection volume, the viscosity of the fluid being injected, the presence of a guidewire, and a comparison of the contrast vs glycerin mixture) on the test system. These trials are described in Examples 4-12 below.
In a fourth example, trial procedure 4400 was performed to compare the performance of a traditional insert catheter (e.g., a Cook-brand catheter) and the insert catheter described herein (e.g., a Telos-brand catheter). Both catheters had the same length and injection parameters.
Table I below shows a baseline comparison between the performance of the two catheters. The various settings of the power injector are listed, as well as catheter properties. The “Max Medrad pressure” column lists the maximum pressure reached during a Medrad injection. This pressure is an approximate value. The “Flow Rate Difference” column indicates how much larger the bigger value is compared to the smaller value. Finally, the “T test” column indicates the p-value calculated from performing a T test with the two samples in the trial. Trials with 3 samples show the p-value calculated from an ANOVA test. P-values of less than 0.05 indicate that the differences in samples of the trial are considered statistically significant. Underneath these p-values are values for the sample sizes, signified with “n=”.
As shown by the results in Table I, the Telos insert catheter described herein closely mimicked the injection properties of the traditional Cook insert catheter, while keeping the guidewire in place in the Telos insert catheter during injection. Both the injection pressure and measured flow rates with the Cook catheter and the Telos catheter are very similar. There is only a 1% difference in flow rate between the two catheters, and a T-test yields a p-value of 0.39, indicating that there is not a significant difference in flow rate. This was achieved by designing the effective cross-sectional areas of the two catheters to be very similar. The Telos catheter has an effective cross-sectional area of 0.001407 square inches (exclusive of the guidewire), compared to the Cook catheter, which had an effective cross-sectional area of 0.001257 square inches (based on the lumen diameter of the catheter without a guiding element positioned in the lumen).
In a fifth example, trial procedure 4400 was performed to determine the effect of the length of the access catheter 2902 on the test system's performance. The trials (“Trials 1”, “Trial 2”, “Trial 3”) were conducted using access catheters 2902 with a length of 193 cm and access catheters 2902 with a length of 100 cm. The results of Trials 1, 2 and 3 are shown in Table II below.
Trial 2 was chosen for analysis due to it being performed with Omnipaque 300 contrast fluid, rendering it the most representative of an actual injection. The two data points in the trial had a sample size of 10 each. A T-test of the data yielded a p-value of 1.77 E-11, indicating that there is a significant difference between the two catheter length data.
The relationship between catheter length and flow rate is graphically represented in
In a sixth example, trial procedure 4400 was performed to determine the effect of the guidewire diameter on the test system's performance. These trials (“Trial 4” and “Trial 5”) used an Acist pump, and a guidewire with a length of 193 cm. The results of Trials 4 and 5 are shown in Table III below.
Trials 4 and 5 were conducted using guidewires with core diameters of 0.018 inch, 0.020 inch, and 0.022 inch. The different guidewire diameters were tested using the same injection parameters (e.g., injection rate, injection volume, injection fluid) and insert catheter. The difference in the flow rates was found to be significant, as the F-statistic from an ANOVA test was 0.000001.
An important finding during the guidewire testing occurred during testing for Trial 5. The goal of this testing was to determine the required injection rate to achieve an output flow rate of 2 ml/s for the different guidewire sizes. This was performed at an injection volume of 7.5 ml. The tests with 0.018 inch and 0.020 inch achieved 2 ml/s output flow relatively easily, but the 0.022 inch wire required very high pressures to achieve 2 ml/s.
When the test system used an Acist pump, output flow was limited due to the high required injection pressures of over 1000 psi. This finding led to a hypothesis that a 0.024 inch guidewire would require even higher injection pressures, and therefore would not be desirable.
Therefore, Trials 4 and 5 allowed for the conclusion that guidewires (or more generally guiding elements) with an outer diameter of 0.018 inches and 0.020 inches were ideally suited, or nearly so, for the test system where the guidewire was in place in the access catheter during injection. Accordingly, guiding elements (e.g., guidewires) having an outer diameter equal to between about 0.018 inches and about 0.020 inches (e.g., about 0.019 inches) would also be ideally suitable. Also, guiding elements (e.g., guidewires) having an outer diameter smaller than about 0.018 inches can also be used. For example, guiding elements having an outer diameter of about 0.014 inches, about 0.015 inches, about 0.016 inches, about 0.017 inches, and guiding elements having an outer diameter of about between about 0.017 inches and about 0.018 inches. In some embodiments, guiding elements having an outer diameter of less than about 0.014 inches can also be used. The structure of the guiding element may be determined by stiffness and functional requirements. In some typical examples the guiding element can have an outer diameter are about 0.018 inches or about 0.020 inches, or between about 0.018 inches and 0.020 inches to satisfy functional requirements (e.g., stiffness) and fluid flow requirements while the guiding element is positioned in the access catheter when fluid is provided through the access catheter.
In a seventh example, trial procedure 4400 was performed to determine the effect of a guidewire with a hydrophilic coating on the test system's performance. The trial (“Trial 6”) used a Medrad pump, and a 193 cm long catheter. The same injection rate, injection volume and 56% Glycerin contrast were used. The results of Trial 6 are shown in Table IV below.
A t-test performed on the data yielded a corresponding p-value 0.6, indicating that there was not a significant difference in the flow rates of an insert catheter with a coated vs uncoated guidewire, suggesting that hydrophilic coating of the guidewire has negligible effect on flow rate.
In an eighth example, trial procedure 4400 was performed to determine the effect of raising injection rates on the output flow rate out of the catheter. Each trial was run using an Acist pump, an 0.018 inch-diameter coated guide wire and Omnipaque 300 contrast. The results of are shown in Table VI below.
Due to short supply of contrast, tests were not completed for the 5, 6, and 7 ml/s injection rate trials with the 7.5 volume. It was assumed that the data would be similar enough to draw conclusions with the 8 ml volume instead of 7.5 ml.
Several different factors may account for this phenomenon, one being that there is an inherent ramp up time for the power injectors, and because of the short injection times used in the experiments, the power injectors have difficulty actually achieving the higher injection rates. Another explanation is that the longer lengths of the catheters may introduce some lag into the system so that the injection rate is reached in the correct amount of time, but then the catheter continues to drain for a period of time afterwards. This is verified by the shorter recorded flow times of the 100 cm-length catheter as opposed to the 193 cm-catheter. Air bubbles present in the pressure gauge caused even more lag in preliminary experiments. Finally, the increase in input flow rate causes an increase in pressure, which in turn may cause the catheter to expand, therefore changing the control volume and decreasing output flow.
In a ninth example, trial procedure 4400 was performed to determine the effect of increasing injection volumes on the output flow rate of the test system. These trials (“Trial 7” and “Trial 8”) were both conducted with a Medrad pump. The results from Trials 7 and 8 can be seen in Table VI below.
When testing with larger injection volumes, it was apparent that volume had a positive effect on output flow rate as seen in
While the injection volume is an important part of an injection, it is an easily changeable parameter that can be adjusted as needed. Additionally, it was not realistic to carry out large volume tests with contrast, as it is expensive, and in short supply. While an increased volume did have a large effect on the flow rate when testing with large volumes like 30 ml, these volumes are not realistic for an actual procedure. A hypothesis for why the flow rate is so much higher for the larger volume injections is that the power injector has a ramp up time and increasing the overall injection time reduces the impact of the ramp up time on the overall flow rate. Additionally, any error in measuring the flow rate is mitigated by the longer period of steady state flow.
In a tenth example, trial procedure 4400 was performed to determine the effect of the viscosity of the injection fluid on the output flow rate of the test system. This trial (“Trial 9”) was conducted with a Medrad pump. The results from Trial 9 can be seen in Table VII below.
The viscosity testing was performed with varying viscosities and all the other variables held as controls. This is seen in Trial 9, where the corresponding injection pressures and flow rates are shown. This data can be visualized in
In an eleventh example, trial procedure 4400 was performed to determine the effect of the guidewire's presence within the lumen of the access catheter on the output flow rate of the test system. These trials (“Trial 10” and “Trial 11”) were conducted with a Medrad pump. The results of Trials 10 and 11 can be seen in Table VIII below.
This testing was performed to act as a baseline in determining the effect that the guidewire has on the flow rate of the catheter. As expected, the flow rates were significantly different with injection over a guidewire as opposed to no guidewire. Trial 10 used water as the fluid, which yielded a p-value of 5.182E-06. Water was chosen for this test as it is well established as a Newtonian fluid, whereas the glycerin solution appears to have varied flow properties.
Trial 10 showed a 30 psi increase in pressure when injecting over the 0.018″ guidewire, as well as a flow decrease of 0.52 ml/s. The pressure increase and flow decrease observed would be magnified using a higher viscosity fluid such as contrast.
In a twelfth example, trial procedure 4400 was performed to determine if a glycerin solution could be made to mimic the properties of contrast for testing purposes. This glycerin solution could then be used in lieu of contrast, due to the shortage and expense of contrast. This trial (“Trial 12”) used a Medrad pump. The results of Trial 12 can be seen in Table IX below.
For Trial 12, power injections were performed holding all factors constant except for the fluid being injected and the corresponding pressure and output flow rate. The two fluids used were supposed to have similar viscosities at about 11.9 cP (please reference “Glycerin Viscosity Measurements” document above for how this was done). Performing the injections showed significantly different flow rates and pressures, with a p-value of 0.0235, with the glycerin having a much lower pressure and flow than the Omnipaque 300 contrast. This indicates that a glycerin mixture should not be used as a model for the contrast due to varying flow properties between the two.
An important thing to note is that the glycerin solutions were mixed to achieve the 11.9 cP and 26.6 cP viscosities based off a calculator.
The measured time was then converted into a centistoke viscosity value using a time-to-viscosity calculator. The centistoke value was then multiplied by the specific gravity of the glycerin solution to determine the centipoise (cP) viscosity value of the glycerin solution.
The calculated viscosity value was then checked against the expected viscosity value output by a glycerin viscosity calculator to confirm the accuracy of the method.
Using the manual viscosimeter with a solution of 64% glycerin yielded times of about 35 seconds, translating to a calculated viscosity value of about 7-8 cP. However, the expected viscosity of a 64% glycerin solution (output from the glycerin viscosity calculator) is 20 cP. Although the glycerin viscosity calculator may not be fully accurate, the fact that the percent error was over 100%, suggests that using a manual viscosimeter is not a reliable method for calculating viscosity in present application.
While the manual viscosimeter was not useful for determining exact viscosities, it was useful for relative viscosity measurements between liquids. The recorded time for the solutions to exit the fixed volume of the manual viscosimeter can be seen in Table X below:
These measurements show that the contrast and 56% glycerin mixture behave somewhat similarly, although more testing may be required to confirm whether the two solutions have the same flow properties under a power injection.
While the foregoing describes robotically driven interventional devices and manually driven interventional devices, the devices may be manually driven, robotically driven, or any combination of manually and robotically driven that are driven by a drive table, other suitable robotic drive systems or mechanisms may be used to drive the interventional devices, as will be appreciated by those of skill in the art in view of the disclosure herein.
Various systems and methods are described herein primarily in the context of a neurovascular access or procedure (e.g., neurothrombectomy). However, the catheters, systems (e.g., drive systems), and methods disclosed herein can be readily adapted for any of a wide variety of other diagnostic and therapeutic applications throughout the body, including particularly intravascular procedures such as in the peripheral vasculature (e.g., deep venous thrombosis), central vasculature (pulmonary embolism), and coronary vasculature, as well as procedures in other hollow organs or tubular structures in the body.
The foregoing description details certain embodiments of the systems, devices, and methods disclosed herein. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the systems, devices, and methods can be practiced in many ways. As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects of the invention should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the technology with which that terminology is associated.
Conditional language such as, among others, “can,” “could,” “might” or “may,” unless specifically stated otherwise, are otherwise understood within the context as used in general to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment.
Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts may have applicability throughout the entire specification.
Many variations and modifications may be made to the above-described embodiments, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. The foregoing description details certain embodiments. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the systems and methods can be practiced in many ways. As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects of the systems and methods should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the systems and methods with which that terminology is associated.
It will also be understood that, when a feature or element (for example, a structural feature or element) is referred to as being “connected”, “attached” or “coupled” to another feature or element, it may 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 may be no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown may 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 and implementations only and is not intended to be limiting. For example, as used herein, the singular forms “a,” “an” and “the” may be 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, processes, functions, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, processes, functions, 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 “/.”
In the descriptions above and in the claims, phrases such as “at least one of” or “one or more of” may occur followed by a conjunctive list of elements or features. The term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and/or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.
Spatially relative terms, such as “forward”, “rearward”, “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 due to the inverted state. Thus, the term “under” may encompass both an orientation of over and under, depending on the point of reference or orientation. 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 may be used herein for the purpose of explanation only unless specifically indicated otherwise.
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 numeric values of 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, may represent endpoints or 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” may be 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 may be considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units may be also disclosed. For example, if 10 and 15 may be disclosed, then 11, 12, 13, and 14 may be also disclosed.
Although various illustrative embodiments have been disclosed, any of a number of changes may be made to various embodiments without departing from the teachings herein. For example, the order in which various described method steps are performed may be changed or reconfigured in different or alternative embodiments, and in other embodiments one or more method steps may be skipped altogether. Optional or desirable 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 the purpose of example and should not be interpreted to limit the scope of the claims and specific embodiments or particular details or features disclosed.
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. The present application claims the benefit of U.S. Provisional Application No. 63/477,370, filed Dec. 27, 2022, the entire contents of which is incorporated by reference herein for all purposes and forms a part of this specification.
| Number | Date | Country | |
|---|---|---|---|
| 63477370 | Dec 2022 | US |
