Imaging system including an imaging probe and a delivery device

Abstract

To provide an imaging system, especially an optical imaging system of a nervous system and a heart system including an imaging probe and a delivery device.SOLUTION: There is provided a system 10 including an imaging probe 100 and at least one delivery catheter 50. The imaging probe includes a shaft 110, a rotatable optical core, and an optical assembly 130. The shaft includes a lumen extending between a proximal end part 111 and a distal part 118. The optical core is disposed in the lumen of the shaft, and includes a proximal end part and a distal end part. The optical core is configured so as to be connected to an interface unit optically and mechanically. The optical assembly is disposed at the distal part of the shaft and is close to the distal end part of the optical core. The optical assembly is configured so as to guide light to a tissue and collect reflection light from the tissue. The delivery catheter is configured so as to engage slidably with the imaging probe.SELECTED DRAWING: Figure 1

Description

Related Applications

[0001] This application claims priority to U.S. Provisional Application No. 62 / 212,173, entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed August 31, 2015, and U.S. Provisional Application No. 62 / 368,387, entitled "Imaging System Includes Imaging Probe and Delivery Devices," filed July 29, 2016, the entire contents of each of which are incorporated herein by reference.

[0002] This application is related to U.S. Provisional Application No. 62 / 212,173, filed August 31, 2015, entitled "Imaging System Includes Imaging Probe and Delivery Devices," and International PCT Patent Application No. PCT / US2016 / 027764, filed April 15, 2016, entitled "Micro-Optic Probes for Neurology," the contents of each of which are incorporated herein by reference in their entirety. [Technical Field]

[0003] The present concepts relate generally to imaging systems, and more particularly to optical imaging systems for the nervous and cardiac systems, including imaging probes and delivery devices. [Background technology]

[0004] Imaging probes are commercially available for use in imaging various internal locations within a patient, such as intravascular probes for imaging the patient's heart. Current imaging probes are limited in their ability to reach certain body locations due to their size and stiffness. Current imaging probes are inserted using a guidewire, which can compromise the placement of or limit the use of one or more delivery catheters through which the imaging probe is inserted. What is needed is an imaging system that includes a probe with high flexibility and small diameter that can navigate to the patient location to be imaged without a guidewire, and one or more delivery devices that can accommodate the improved imaging probe. Summary of the Invention [Means for solving the problem]

[0005] According to one aspect of the inventive concept, an imaging system includes an elongate shaft having a proximal end, a distal portion, and a lumen (or tube) extending between the proximal end and the distal portion. The imaging probe further includes a rotatable optical core disposed within the lumen of the elongate shaft, the rotatable optical core having a proximal end and a distal end, and an optical assembly disposed within the distal portion of the elongate shaft proximate the distal end of the rotatable optical core, the rotatable optical core configured to be optically and mechanically coupled to the interface unit, and the optical assembly configured to direct light to tissue and collect reflected light from the tissue. The imaging probe is configured and arranged to collect image data from a patient site. The system further includes at least one delivery device (e.g., a first delivery catheter) configured and arranged to slidingly engage (e.g., slidingly receive) the imaging probe. The imaging system may further include a rotation assembly configured and arranged to rotate the optical assembly. The imaging system may further include a retraction assembly constructed and arranged to retract the optical assembly and the elongate shaft (eg, retract the elongate shaft to retract the elongate shaft and the optical assembly together).

[0006] In certain embodiments, the imaging probe is configured and arranged to prevent relative movement between the elongate shaft and the optical assembly. In these embodiments, the elongate shaft may have a transparent segment (e.g., a transparent segment disposed around the optical assembly) that is 15 mm or less, 6 mm or less, or 4 mm or less in length. The imaging probe may further include a connector rotatably attached to the rotatable optical core and fixedly attached to the elongate shaft, the connector configured and arranged to prevent relative movement between the elongate shaft and the rotatable optical core.

[0007] In some embodiments, the imaging system comprises an OCT imaging system.

[0008] In one embodiment, the imaging probe comprises a distal portion of an elongate shaft having an outer diameter (OD) of 0.025 inches or less.

[0009] In one embodiment, the imaging probe comprises a distal portion of an elongated shaft having an outer diameter of 0.022 inches or less.

[0010] In one embodiment, the imaging probe comprises a distal portion of an elongated shaft having an outer diameter of 0.018 inches or less.

[0011] In one embodiment, the imaging probe comprises a distal portion of an elongated shaft having an outer diameter of 0.016 inches or less.

[0012] In one embodiment, the imaging probe comprises a distal portion of an elongated shaft having an outer diameter of 0.015 inches or less.

[0013] In one embodiment, the imaging probe comprises a distal portion of an elongated shaft having an outer diameter of 0.014 inches or less.

[0014] In some embodiments, the elongate shaft of the imaging probe is constructed from PEEK, polyimide, nylon, FEP, PTFE, Pebax, and combinations thereof.

[0015] In some applications, the distal portion of the elongate shaft of the imaging probe has a blade portion.

[0016] In certain embodiments, the at least one delivery device comprises at least one delivery catheter configured and arranged to slidingly receive the imaging probe, and may be a catheter selected from the group consisting of a 5 Fr to 7 Fr guide catheter, an intermediate catheter having an inner diameter (ID) of 0.053 inches to 0.070 inches, a microcatheter having an ID of 0.0165 inches to 0.027 inches, and combinations thereof. The at least one delivery device may further comprise at least a first guidewire. The at least one delivery device may further comprise at least a second guidewire having an outer diameter smaller than the outer diameter of the first guidewire. The at least one delivery catheter may have an inner diameter of about 0.021 inches or an inner diameter of at least 0.0165 inches. The at least one delivery catheter may have an inner diameter of about 0.027 inches. The at least one delivery device may be configured and arranged to receive an optically clear fluid therein. The at least one delivery catheter may have a proximal portion and a Touhy valve disposed therein. The at least one delivery catheter may be a catheter having an outer diameter of about 0.0240 inches and an inner diameter of about 0.0165 inches. The at least one delivery catheter may include a distal end and a marker proximate the distal end. The marker may be a marker selected from the group consisting of a radiopaque marker, an ultrasound visible marker, a magnetic marker, and combinations thereof. The at least one delivery catheter may comprise a shaft having a distal portion including a transparent segment. The transparent segment may have an outer diameter of about 0.022 inches and an inner diameter of about 0.0165 inches. The transparent segment may be up to 50 cm in length. The transparent segment may be up to 10 cm in length. The transparent segment may be up to 5 cm in length. The transparent segment may be configured to advance within the deployed device, and the optical assembly may be configured to retract within the transparent segment.The implanted device may comprise a device selected from the group consisting of a flow diverter, a pipeline flow diverter, a coil, a stent, a covered stent, an aneurysm treatment implant, and combinations thereof.

[0017] In one aspect, At least one delivery device is constructed and arranged to slidingly receive the elongate shaft, and the at least one delivery device includes a transparent distal portion.

[0018] In some embodiments, the at least one delivery device comprises at least one guidewire. The at least one guidewire may be configured and disposed to slidingly engage the imaging probe. The imaging probe may have a rapid exchange lumen in a distal portion of its elongate shaft. The at least one delivery device may further comprise at least one delivery catheter configured and disposed to slidingly receive the at least one guidewire. The at least one guidewire may be a guidewire having an outer diameter of 0.035 inches to 0.038 inches, a guidewire having an outer diameter of 0.010 inches to 0.018 inches, a guidewire having an access length such as a guidewire having a length of about 200 cm, a guidewire having an exchange length such as a guidewire having a length of about 300 cm, a guidewire having a length of 175 cm to 190 cm, a guidewire having a length of 200 cm to 300 cm and / or an outer diameter of 0.014 inches to 0.016 inches, a hydrophilic guidewire, a Stryker Synchro™ guidewire, a Terumo guidewire such as a Terumo Glidewire™, a Terumo The guidewire may be selected from the group consisting of Traxcess™ guidewire, X-Celerator™ guidewire, X-Pedion™ guidewire, X-Pedion™ guidewire, Agility™ guidewire, Bentson™ guidewire, Coon™ guidewire, Amplatz™ guidewire, and combinations thereof.

[0019] In one embodiment, the imaging probe has a diameter (e.g., outer diameter) of 0.014 inches to 0.016 inches, and the at least one delivery device includes a guidewire configured and positioned to access a patient site, the patient site including a nervous system or cardiac site. The at least one delivery device may have an inner diameter of 0.021 inches to 0.027 inches and may further include a first delivery catheter configured and positioned to be advanced over the guidewire to the patient site. The imaging probe is configured and positioned to be advanced within the first delivery catheter after the guidewire is removed from the first delivery catheter, and the first delivery catheter is configured and positioned to retract the imaging probe after advancing it therethrough, and the imaging probe can be configured to be retracted after retraction of the first delivery catheter, and retraction of the imaging probe can be performed while collecting image data. The system may further comprise a flushing medium positioned and configured to be delivered through the first delivery device when retracting the imaging probe to collect image data (e.g., a flushing medium passing between the imaging probe and the first delivery device). The imaging probe may be configured and arranged to be removed from the first delivery catheter after collecting the image data, and the guidewire may be positioned and configured to be inserted into the first delivery catheter after removing the probe. The neural or cardiac site may be at least one aneurysm, stenosis, thrombus, or implant.

[0020] In one embodiment, the at least one delivery device comprises a first guidewire configured to access a patient site (e.g., a neural or cardiac site), a first delivery catheter having an inner diameter of 0.021 inches to 0.027 inches, and a transparent segment having a distal portion configured to be advanced over the guidewire to the patient site. The system is configured to collect image data by retracting the optical assembly with the optical assembly positioned in the transparent portion of the first delivery catheter. The distal portion of the elongate shaft of the imaging probe may have an outer diameter of 0.014 inches to 0.016 inches.

[0021] In some embodiments, the patient site is a neurological site or a cardiac site, and the patient site may be a site selected from the group consisting of an aneurysm, a stenosis, a thrombus, an implant, and combinations thereof.

[0022] In one embodiment, the at least one delivery device comprises a first guidewire configured to access a patient site (e.g., such as when the patient site is a neural or cardiac site), a first delivery catheter having an inner diameter of approximately 0.27 inches and configured to be advanced over the first guidewire, and a second delivery catheter including an outer diameter of approximately 0.025 inches and a distal portion including a transparent segment. The second delivery catheter may be advanced over the first guidewire through the first delivery catheter and configured to slidingly receive an imaging probe. The imaging probe may have a diameter (e.g., outer diameter) of approximately 0.016 inches.

[0023] In one embodiment, the at least one delivery device comprises a first delivery catheter having a proximal portion with a 5 French to 7 French guide catheter and a Touhy valve, and a second delivery catheter configured to be slidably received by the first delivery catheter and configured to slidably receive the imaging probe. The system may further include a third delivery catheter configured to be slidably received by the second delivery catheter and configured to slidably receive the imaging probe. The imaging probe may have a diameter (e.g., outer diameter) of 0.014 inches to 0.016 inches.

[0024] In some embodiments, the at least one delivery device comprises at least one delivery catheter and a probe, and the at least one delivery catheter is constructed and arranged such that the optical assembly resides beyond the distal end of the at least one delivery catheter during collection of image data. The system may be configured to retract the optical assembly during collection of image data. The distal portion of the elongate shaft of the imaging probe may have an outer diameter of approximately 0.014 inches. The at least one delivery catheter may have an outer diameter of approximately 0.022 inches. The distal portion of the elongate shaft of the imaging probe may have an outer diameter between 0.014 inches and 0.016 inches, and the at least one delivery catheter may have an outer diameter of approximately 0.032 inches. The imaging probe may have a length up to 200 cm, and the at least one delivery catheter may have a length at least 2 cm shorter than the length of the imaging probe. The imaging probe may further include a spring tip at the distal end of its elongate shaft. The spring tip may comprise a radiopaque portion. The spring tip may have a length of 2 cm to 3 cm. The at least one delivery device may further comprise a guide catheter having a proximal end including a Touhy valve. The imaging probe may be configured to be removable from the at least one delivery catheter. The system may further comprise a treatment device configured to be inserted through the at least one delivery catheter.

[0025] In some embodiments, the at least one delivery device comprises at least one delivery catheter having a distal portion with a transparent segment, and the probe and at least one delivery catheter are constructed and arranged such that the optical assembly resides within the transparent segment of the at least one delivery catheter during data collection. The elongate shaft of the imaging probe may have an outer diameter of approximately 0.014 inches. The at least one delivery catheter may have an inner diameter of approximately 0.0165 inches. The at least one delivery catheter may have an outer diameter of approximately 0.022 inches. The distal portion of the at least one delivery catheter may comprise a marker. The at least one delivery catheter may comprise a spring tip. The at least one delivery catheter may comprise a rapid exchange tip.

[0026] In one embodiment, the at least one delivery device comprises a first delivery catheter having an introducer, such as a vascular introducer, a second delivery catheter having a guide catheter, such as a 6 Fr guide catheter, including a distal end for placement near the aortic arch, and a third delivery catheter having an inner diameter of 0.021 inches to 0.027 inches and a distal end configured and positioned to be advanced distally, such as in the middle cerebral artery (MCA). The distal end of the third delivery catheter may be configured and positioned proximal to a location selected from the group consisting of the internal ceratoid artery, the intracranial internal carotid artery (from the cervical ICA), the petrous ICA, the proximal cavernous ICA, the distal cavernous / clinoidal ICA, the supraclinoid ICA, the M1 segment V3-4 junction of the vertebral artery, the distal V4, the proximal basilar, the proximal-mid basilar, and the mid-basilar, and combinations thereof.

[0027] In one embodiment, the at least one delivery catheter comprises a first delivery catheter having an introducer with an inner diameter of 7 French to 9 French; a second delivery catheter configured to be slidably received within the first catheter and comprising a guide catheter configured to be slidably received by the first delivery catheter having an inner diameter of 5 French to 7 French, a Touhy valve, and / or a length of about 90 cm; a third delivery catheter configured to be slidably received by the second catheter and comprising an intermediate catheter having an outer diameter less than 7 French and / or a length of about 115 cm; and a fourth delivery catheter having an inner diameter of less than 0.027 inches; a first guidewire configured to be slidingly received by the first, second, third, and / or fourth delivery catheter and having a length of 175 cm to 190 cm; a second guidewire configured to be slidingly received by the first, second, third, and / or fourth delivery catheter and having a length of 175 cm to 190 cm; and combinations thereof. The system may further comprise a power injector. The system may further comprise an implant having a flow diverter. The flow diverter may comprise at least one of a Pipeline™ flow diverter or a Pipeline Flex™ flow diverter.

[0028] In one embodiment, the at least one delivery catheter comprises an element selected from the group consisting of a first delivery catheter having an introducer with an inner diameter of 7 French to 9 French; a second delivery catheter configured to be slidingly received by the first delivery catheter and having an inner diameter of 5 French to 7 French, a Touhy valve, and / or a guide catheter with a length of approximately 90 cm; a third delivery catheter configured to be slidingly received by the second delivery catheter and having an intermediate catheter with an outer diameter less than 7 French and / or a length of approximately 115 cm; a fourth delivery catheter configured to be slidingly received by the third delivery catheter and having a Surpass™ delivery catheter, an outer diameter less than 3.3 French or less than 3.7 French, and / or a length of approximately 135 cm; a first guidewire configured to be slidingly received in the first delivery catheter, the second delivery catheter, the third delivery catheter, and / or the fourth delivery catheter and having an exchange length, and combinations thereof. The system may further comprise an implant having a flow diverter, which may comprise at least one of a Surpass™ flow diverter or a Surpass Future™ flow diverter.

[0029] In one embodiment, the at least one delivery catheter comprises an element selected from the group consisting of: a first delivery catheter having an introducer with an inner diameter of 7 French to 9 French; a second delivery catheter configured to be slidingly received by the first delivery catheter and comprising a guide catheter with an inner diameter of 5 French to 7 French, an inner diameter of approximately 0.088 inches, a length of 80 cm to 90 cm, and / or a distal end configured to be positioned near the aortic arch; a third delivery catheter configured to be slidingly received by the second delivery catheter and comprising a reperfusion catheter with an outer diameter of 3.8 French to 5.4 French and / or a length of 132 cm to 153 cm; a fourth guide catheter configured to be slidingly received by the third delivery catheter and having an outer diameter of approximately 2.6 French and / or a length of approximately 160 cm; and combinations thereof.

[0030] In one embodiment, the at least one delivery catheter comprises: a first delivery catheter having an introducer with an inner diameter of between 7 French and 9 French; a second delivery catheter configured to be slidingly received by the first delivery catheter and comprising a guide catheter with an inner diameter of between 5 French and 7 French, a Touhy valve, and / or a length of about 90 cm; and a third delivery catheter configured to be slidingly received by the second delivery catheter and comprising an intermediate catheter with an outer diameter less than 7 French and / or a length of about 115 cm. a fourth delivery catheter configured to be slidingly received by the third delivery catheter and comprising a microcatheter having an inner diameter of about 0.0165 inches and / or a length of about 150 cm; a first guidewire configured to be slidingly received in the first delivery catheter, the second delivery catheter, the third delivery catheter, and / or the fourth delivery catheter and comprising an element selected from the group consisting of: an outer diameter of about 0.014 inches and / or a length of 175 cm to 190 cm; and combinations thereof. The system may further comprise an automatic injector. The system may further comprise a treatment device comprising a coil deployment catheter. The system may further comprise at least one coil.

[0031] In some embodiments, the system further comprises a treatment device. The collected data may include treatment device data. The treatment device may be selected from the group consisting of a vascular stenosis or other narrowing, a drug-eluting balloon, an aspiration catheter; a clot removal device such as a sonolysis device, an atherectomy device, a stent retriever, a Trevo™ stentriever, a Solitaire™ stentriever, a Revive™ stentriever, an Eric™ stentriever, a Lazarus™ stentriever, a stent delivery catheter, a microblade implant, an embolization system, a WEB™ Embolization System, a Luna™ Embolization System, a Medina™ Embolization System, and combinations thereof. The treatment device may comprise a clot removal device. The clot removal device may comprise a stent retriever device.

[0032] In some embodiments, the system may further comprise an implant. The collected image data may include treatment device data. The implant may comprise a device selected from the group including a flow diverter, a Pipeline™ flow diverter, a Surpass™ flow diverter, an embolization coil, a stent, a Wingspan™ stent, a covered stent, an aneurysm treatment implant, and combinations thereof. The implant may comprise an aneurysm treatment implant. The implant may comprise a flow diverter. The implant may comprise a covered stent. The implant may comprise a stent. The implant may comprise a coil.

[0033] In some embodiments, the system may comprise a console including an assembly selected from the group consisting of a rotation assembly, a retraction assembly, an imaging assembly, a light source, an algorithm, a display, and combinations thereof.

[0034] In some embodiments, the system further comprises an imaging assembly configured to provide light to and collect light from the optical assembly. The imaging assembly may comprise a light source. The light source may comprise at least two light sources. The light source may be configured to provide light having a central wavelength between 800 nm and 1700 nm. The light source may be configured to provide light having a central wavelength of about 1300 nm or about 1380 nm. The light source may be configured to provide light having a bandwidth of 5% to 15% of the central wavelength. The light source may be configured to provide light in a 1.3 μm band. The light source may be configured to provide light at a power level of about 20 mW.

[0035] In some embodiments, the system further includes a rotation assembly configured and arranged to rotate the optical assembly. The rotation assembly may be configured and arranged to rotate the optical assembly at a speed between 40 rps and 1000 rps. The rotation assembly may be configured and arranged to rotate the optical assembly at a speed between 50 rps and 2500 rps or between 150 rps and 2500 rps. The rotation assembly may be configured and arranged to rotate the optical assembly at a speed of approximately 250 rps. The rotation assembly may be configured and arranged to rotate the optical assembly at a speed of approximately 250 rps. The system may be configured to operate in an imaging mode and a preview mode, and the rotation assembly may be configured and arranged to rotate the optical assembly at a first speed during the imaging mode and at a second speed during the preview mode, which may be slower than the first speed. The rotation assembly may be constructed and arranged to rotate the optical assembly at a rate of 40 rps to 1000 rps during imaging mode and at a rate of 30 rps to 140 rps during preview mode. The system may be configured to linearly position the optical assembly during preview mode.

[0036] In certain embodiments, the system further comprises a retraction assembly configured and arranged to retract at least the optical assembly. The retraction assembly can be configured and arranged to retract the elongate shaft of the imaging probe (e.g., retract the elongate shaft and the optical assembly together). The retraction assembly can be configured and arranged to retract the optical assembly at a rate of 5 mm / sec to 60 mm / sec during collection of image data. The retraction assembly can be configured and arranged to retract the optical assembly at a rate of approximately 40 mm / sec during collection of image data. The retraction assembly can be constructed and arranged to retract the optical assembly a distance of 10 mm to 150 mm during collection of image data. The retraction assembly can be constructed and arranged to retract the optical assembly a distance of approximately 40 mm during collection of image data. The retraction assembly can be configured and arranged to retract the optical assembly for a time period of 2 seconds to 15 seconds during collection of image data.

[0037] In some embodiments, the system further comprises an algorithm configured to adjust operational parameters. The operational parameters may include rotation-related parameters, such as the rotational speed of the rotatable optical core and / or optical assembly; pullback parameters of the imaging probe's elongated shaft and / or optical assembly, such as the pullback speed, distance, start position, end position, and / or pullback initiation timing; positional parameters, such as the position of the optical assembly; line spacing parameters, such as the number of lines per frame; image display parameters, such as the scaling of display size relative to the vessel diameter; structural parameters of the imaging probe; injectate parameters, such as the saline-to-contrast ratio, configured to determine the appropriate refractive index; light source-related parameters, such as the delivered power (output) and / or delivered light frequency; and combinations thereof. The algorithm may include pullback parameters selected from the group consisting of: a parameter related to a trigger that initiates pullback of the imaging probe's elongated shaft; pullback parameters adjusted based on the lumen cleanliness; pullback parameters adjusted based on a signal from the injector; pullback parameters adjusted based on collected image data; imaging probe parameters, such as the arm path length; and combinations of one or more thereof.

[0038] In some embodiments, the system further comprises a display configured to display one or more images based on the collected image data. The display may be capable of displaying video based on the collected image data. The display may be configured to display images at a frame rate of 250 frames per second or less.

[0039] In some embodiments, the system (e.g., an imaging probe or other system element) further comprises a functional element. The functional element may comprise at least two functional elements. The functional element may include an element selected from the group consisting of a sensor, a transducer, and combinations thereof. The functional element may comprise a sensor configured to generate a signal. The functional element may comprise a sensor selected from the group consisting of a physiological sensor; a pressure sensor; a strain gauge; a position sensor; a GPS sensor; an accelerometer; a temperature sensor; a magnetic sensor; a chemical sensor; a biochemical sensor; a protein sensor; a flow sensor (e.g., an ultrasonic flow sensor); a gas detection sensor (e.g., an ultrasonic bubble detector); an acoustic sensor (e.g., an ultrasonic sensor); and combinations thereof. The sensor may include a physiological sensor selected from the group consisting of a pressure sensor (e.g., a blood pressure sensor); a blood gas sensor; a flow sensor (e.g., a blood flow sensor); a temperature sensor (e.g., a blood or other tissue temperature sensor); and combinations thereof. The sensor may comprise a position sensor configured to generate a signal related to vascular pathway conditions (e.g., 2D or 3D vascular pathway structure). The sensor may comprise a magnetic sensor. The sensor may comprise a flow sensor. The system may further comprise an algorithm configured to process a signal generated by the sensor. The functional element may comprise a transducer. The functional element may comprise a transducer selected from the group consisting of a heating element, such as a heating element configured to provide heat sufficient to ablate tissue; a cooling element, such as an element configured to provide cryogenic energy to ablate tissue; an acoustic transducer, such as an ultrasound transducer; a vibration transducer; and combinations thereof. The functional element may comprise a pressure relief valve. The functional element may comprise at least one side hole. The functional element may include a visualizeable marker. The functional element may include a deployable functional element. The functional element may include a deployable functional element. The imaging probe may include the functional element. The functional assembly may be proximate to the optical assembly.The system may further comprise a console, the console may comprise the functional elements. The system may further comprise an injector, the injector may comprise the functional elements.

[0040] In some embodiments, the system further comprises an injector configured and positioned to deliver injectate to at least one delivery device. The injector may be configured to deliver fluid to perform a flushing procedure. The flushing procedure may be performed based on parameters selected from the group consisting of a predetermined volume of injectate to be delivered; a predetermined time between delivery of injectate; a predetermined time from the time before retraction of the elongate shaft of the imaging probe until completion of image data collection; and combinations thereof. The system may comprise one or more fluids delivered by the injector. The injectate may include a fluid selected from the group consisting of: an optically transparent material; saline; a visualizeable material; a contrast agent; dextran; an ultrasound-reflective material, a magnetic material; and combinations thereof. The injectate may comprise saline and a contrast agent. The injectate may comprise at least 20% contrast agent. The injector may include a first reservoir and a second reservoir, and the injectate may comprise a first fluid from the first reservoir and a second fluid from the second reservoir. The injectors may be configured to deliver the first and second fluids in various proportions.

[0041] In accordance with another aspect of the inventive concept, an imaging method comprises: (a) selecting an imaging probe according to any claim herein; (b) selecting at least one delivery device; (c) advancing a first delivery device within a blood vessel of the patient, the first delivery device comprising a first delivery catheter having a first distal end; (d) advancing the imaging probe within the first delivery catheter such that an optical assembly of the imaging probe is positioned proximate to the patient site; (e) retracting the elongate shaft of the imaging probe and acquiring image data of the patient site during the retraction; and (f) generating one or more images based on the collected image data; The optical assembly can be disposed within the first delivery catheter during collection of the image data. The first delivery catheter can comprise a transparent segment, and the optical assembly can reside within the transparent segment during collection of the image data. The optical assembly can be disposed distal to the distal end of the first delivery catheter during collection of the image data.

[0042] In some embodiments, the patient site comprises a blood vessel selected from the group consisting of an artery in the patient's neck, a vein in the patient's neck; an artery in the patient's head; a vein in the patient's head; an artery in the patient's brain; a vein in the patient's brain; and combinations thereof.

[0043] In some embodiments, the patient site is one or more locations near the patient's spine.

[0044] In certain embodiments, the image data includes data representing tissue selected from the group consisting of wall tissue of a blood vessel at the patient site; a thrombus near the patient site; occlusive material near the patient site; the extravascular portion of the blood vessel in which the optical assembly is placed; tissue outside the blood vessel in which the optical assembly is placed; extracellular deposits located outside the lumen of the blood vessel in which the optical assembly is placed; and combinations thereof.

[0045] In some embodiments, step (e) further comprises collecting image data of a device to be placed adjacent to the patient site, and the image formed in step (f) comprises one or more images of the placed device. The placed device comprises a device selected from the group consisting of a flow diverter; an aneurysm repair implant; a stent; a covered stent; a coil, and combinations thereof. Step (e) may comprise collecting image data of an implant placement procedure, and the image formed in step (f) may further comprise one or more images of the implant placement procedure. Step (e) may further comprise collecting image data of a treatment device, and the image formed in step (f) may further comprise one or more images of the treatment device. Step (f) may further comprise forming one or more images of the treatment procedure.

[0046] In certain embodiments, the at least one delivery device comprises at least one delivery catheter constructed and arranged to slidingly receive the imaging probe. The at least one delivery catheter may comprise a catheter selected from the group consisting of a 6 French to 8 French guide catheter, a 5 French to 6 French mid-catheter, a microcatheter having an inner diameter of 0.0165 inches to 0.027 inches (e.g., 0.021 inches to 0.027 inches), and combinations thereof. The at least one delivery device may further comprise at least a first guidewire. The at least one delivery device may further comprise at least a second guidewire having an outer diameter smaller than the outer diameter of the first guidewire.

[0047] In one embodiment, the first delivery catheter has a proximal end, a distal end, and a lumen therebetween, and the imaging probe is advanceable within the first delivery catheter. During step (b), the distal end of the first delivery catheter is advanceable to a location at least partially located within the patient site, and during step (d), the first delivery catheter is withdrawn to expose the optical assembly before performing the withdrawing step (e). In step (e), the optical assembly is able to remain distal to the distal end of the first delivery catheter while collecting image data. During step (b), the distal end of the first delivery catheter is advanceable to a location proximal to the patient site, and the optical assembly is able to remain distal to the distal end of the first delivery catheter while collecting image data in step (e). During step (b), the distal end of the first delivery catheter is advanceable to a location at least partially located within the patient site, and the optical assembly is able to remain within the first delivery catheter while collecting image data in step (e). The first delivery catheter may comprise a transparent segment, and the optical assembly may remain within the transparent segment while collecting the image data in step (e).

[0048] In one embodiment, the at least one delivery device comprises a first guidewire and a microcatheter having an inner diameter of 0.0165 inches to 0.027 inches (e.g., 0.021 inches to 0.027 inches), and the method comprises advancing the first guidewire to a location at or distal to the patient site, advancing the microcatheter over the first guidewire to a location at or distal to the patient site, removing the first guidewire and inserting an imaging probe through the microcatheter to a location at or distal to the patient site, withdrawing the microcatheter to expose an optical assembly, and flushing through at least one of the microcatheter or another delivery catheter while withdrawing the optical assembly during image data acquisition in step (e). The method may further include removing the imaging probe from the microcatheter and inserting a second guidewire through the first delivery catheter. The first guidewire may be a second guidewire. The second guidewire may comprise a different guidewire than the first guidewire. The patient site may comprise a site selected from the group consisting of an aneurysm, a stenosis, a thrombus, an implant, and combinations thereof, and the imaging probe is capable of advancing within at least the patient site.

[0049] In one embodiment, the at least one delivery device comprises a first guidewire and a microcatheter having an inner diameter of 0.0165 inches to 0.027 inches (e.g., 0.021 inches to 0.027 inches) and a distal portion comprising a transparent segment, and the method comprises advancing the first guidewire to a location at or distal to the patient site; advancing the microcatheter over the first guidewire to a location at or distal to the patient site; inserting an imaging probe through the microcatheter to a location at or distal to the patient site, excluding the first guidewire; and flushing through at least one of the microcatheter or another delivery catheter while retracting an optical assembly during the image data acquisition in step (e), wherein the optical assembly remains within the transparent segment of the microcatheter. The method may further include removing the imaging probe from the microcatheter and inserting a second guidewire through the first delivery catheter. The first guidewire may be a second guidewire. The second guidewire may be a different guidewire than the first guidewire. The patient site may comprise a site selected from the group consisting of an aneurysm, a stenosis, a thrombus, an implant, and combinations thereof, and the imaging probe is capable of advancing within at least the patient site.

[0050] In some embodiments, the first delivery catheter includes a distal portion including one or more side holes, and the method further includes delivering the infusate in a flushing procedure, passing the infusate through the one or more side holes (e.g., the infusate exits the lumen of the first delivery catheter via the one or more side holes). The first delivery catheter can be a microcatheter having an inner diameter of 0.027 inches or smaller.

[0051] In one embodiment, a first delivery catheter is advanced to a location proximal to the patient site, and the method comprises advancing an optical assembly of the imaging probe beyond the distal end of the first delivery catheter.

[0052] In some embodiments, the method further comprises deploying the deployable device. The deployable device may be a device selected from the group consisting of a flow diverter, a pipeline flow diverter, a Surpass flow diverter, an embolic coil, a stent, a Wingspan™ stent, a covered stent, an aneurysm treatment implant, and combinations thereof. The patient site may comprise the deployed device or may be a site for deploying a device to be deployed, and the method may comprise advancing an optical assembly of an imaging probe to the patient site, acquiring image data of the patient site, analyzing the acquired image data, and deploying the deployable device based on the analysis. The analysis can modify deployment parameters selected from the group consisting of selection of a deployable device, selection of the porosity of the deployable device, selection of the coverage of the deployable device (e.g., the percentage of the surface area of ​​the vascular portion that is covered by the metal or other material of the deployable device), selection of the pore density of the deployable device, selection of the diameter of the deployable device, selection of the length of the deployable device, selection of the location to deploy the deployable device, expansion parameters for expanding the deployable device once deployed, repositioning the deployable device once deployed, selection of a second deployable device to deploy, and combinations thereof.

[0053] In some embodiments, the method includes accessing a patient site with an optical assembly, collecting image data of the deployed device, analyzing the image data to identify at least one deployment problem, and adjusting the deployment of the deployed device. The identified deployment problem may comprise a problem selected from the group consisting of an incorrectly positioned deployed device, improper expansion of the deployed device, the presence of an air bubble, and combinations thereof.

[0054] In certain embodiments, the method further comprises advancing a diagnostic and / or treatment device through the first delivery catheter while the imaging probe remains within the first delivery catheter. The first delivery catheter may have an inner diameter of 0.050 inches to 0.085 inches. The first delivery catheter may have an inner diameter of 0.053 inches to 0.072 inches. The first delivery catheter may have an inner diameter of 0.070 inches to 0.072 inches. The diagnostic and / or treatment device can be advanced within the first delivery catheter prior to step (c). The diagnostic and / or treatment device can be advanced within the first delivery catheter after step (c). The diagnostic and / or treatment device can have an outer diameter of 0.035 inches or less. The diagnostic and / or treatment device can have an outer diameter of 0.030 inches or less. The diagnostic and / or treatment device can have an outer diameter of 0.025 inches or less. The diagnostic and / or treatment device may have an outer diameter of 0.020 inches or less. The method may further include automatically detecting delivery of a flushing material. The diagnostic and / or treatment device may comprise a treatment device configured to deliver one or more coils to treat the aneurysm. The diagnostic and / or treatment device may comprise a treatment device configured to remove a thrombus. The diagnostic and / or treatment device may comprise a treatment device configured to deliver a stent. The treatment device may be configured to deliver a covered stent. The method may further include performing a medical procedure using the diagnostic and / or treatment device, performing an evaluation of the image data, and determining whether an additional medical procedure is advisable based on the image data. Evaluating the image data may include reviewing 2D and / or 3D images of the patient site SP before, during, and / or after the medical procedure. Evaluating the image data may include evaluating 2D and / or 3D images of an implant placed in the patient during the procedure.The evaluation can determine at least one or more of sufficient occlusion, sufficient occlusion of the aneurysm by placement of a coil or covered stent, proper placement of the implant relative to the tissue, proper flow in the native vessel, and combinations thereof. The method can further include performing an additional medical procedure and collecting additional image data related to the additional medical procedure. The additional medical procedure can be a procedure selected from the group consisting of implantation (or placement) of one or more implants, additional expansion of the implant, and combinations thereof. [Brief explanation of the drawings]

[0055] These and other objects, features, and advantages of embodiments based on the concepts of the present invention will be apparent from a more particular description of the preferred embodiments, as illustrated in the accompanying drawings, in which like reference characters represent the same or similar elements. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the preferred embodiments.

[0056] [Figure 1] FIG. 1 is a schematic diagram of an imaging system comprising an imaging probe and one or more delivery devices according to the concepts of the present invention.

[0057] [Figure 1A] FIG. 1A is an enlarged view of the distal portion of the shaft of the imaging probe of FIG. 1 according to the concepts of the present invention.

[0058] [Figure 2] FIG. 2 is a flow chart of a method for forming an image in accordance with the concepts of the present invention.

[0059] [Figure 3] FIG. 3 is a partial side view of a system based on the concepts of the present invention, comprising an imaging probe and a delivery catheter, the imaging probe comprising an optical assembly configured to collect image data while positioned outside the delivery catheter.

[0060] [Figure 4A-B] 4A and 4B are partially cross-sectional side views showing two configurations of a system comprising an imaging probe and a delivery catheter based on the concepts of the present invention, wherein the imaging probe comprises an optical assembly configured to collect image data while positioned within the distal portion of the delivery catheter.

[0061] [Figure 5] FIG. 5 is an anatomical diagram of a system according to the concepts of the present invention inserted percutaneously into a patient.

[0062] [Figure 6A-E] 6A-E are schematic diagrams showing an inside look at the sequence of steps for forming an image based on the concepts of the present invention, including advancing the imaging probe beyond the distal end of the delivery catheter before collecting image data.

[0063] [Figures 7A-E] 7A-E are schematic diagrams showing an inside view of the image formation process based on the concepts of the present invention, including pulling back the delivery catheter to expose the optical assembly of the imaging probe before collecting image data.

[0064] [Figure 8A-D] 8A-D are schematic diagrams showing an inside view of the image formation process based on the concepts of the present invention, including collecting image data while the optical assembly of the imaging probe is positioned within the delivery catheter.

[0065] [Figure 9A-C] 9A-C are schematic diagrams showing an inside view of the image formation process according to the concepts of the present invention, including advancing a delivery catheter over an imaging probe to the patient site to be imaged.

[0066] [Figures 10A-E] 10A-E are schematic diagrams showing an inside view of the imaging sequence based on the concepts of the present invention, including the removal of a smaller delivery catheter from a larger delivery catheter prior to the insertion of an imaging probe.

[0067] [Figure 11] FIG. 11 is a schematic diagram of a system based on the concepts of the present invention, the system comprising an imaging probe and a delivery catheter having a shaft with a transparent segment.

[0068] [Figure 12] FIG. 12 is a schematic diagram showing the inside of a system based on the concept of the present invention, comprising an imaging probe and a delivery catheter with side holes for supplying flushing fluid.

[0069] [Figure 13] FIG. 13 is a schematic diagram of a system based on the concepts of the present invention, the system comprising an imaging probe, a rotation assembly and a pullback assembly.

[0070] [Figure 14] FIG. 14 is a schematic diagram showing an imaging probe based on the concept of the present invention side-by-side with a second device so that the internal structure can be seen.

[0071] [Figure 15] FIG. 15 is a flow chart of a method for forming an image using an imaging probe in side-by-side relationship with a second device according to the concepts of the present invention. Detailed Description of the Embodiments Shown in the Drawings

[0072] The terms used herein are for the purpose of describing particular embodiments and are not intended to limit the inventive concepts. Moreover, embodiments of the inventive concepts may include multiple novel features, and no single such feature contributes to the desirable properties of the inventive concepts or is essential to practicing the concepts described herein. As used herein, terms that can be understood as singular also include the plural as well, unless the context clearly dictates otherwise.

[0073] Furthermore, the terms "comprising" (or similar terms), "having" (or similar terms), "including" (or similar terms), or "contain" (or similar terms), when used herein, will be understood to mean the presence of stated features, numbers, steps, operations, components and / or elements, but not to exclude the presence of one or more other features, numbers, steps, operations, factors, elements and / or groups.

[0074] Furthermore, although terms such as first, second, and third may be used herein to describe various limitations (or features), configurations, elements, regions, layers, and / or sections, it is understood that these limitations, configurations, elements, regions, layers, and / or sections are not limited by such terms. These terms are merely used to distinguish one limitation, configuration, element, region, layer, or section from another such limitation, configuration, element, region, layer, or section. Thus, a first limitation, configuration, element, region, layer, or section described below could be referred to as a second limitation, configuration, element, region, layer, and / or section without departing from the teachings of the present application.

[0075] It will be further understood that when an element is described as "on," "mounted," "connected," or "coupled" to another element, it may be directly "on," "connected," or "coupled" to the other element, or one or more intervening elements may be present. Conversely, when an element is described as "directly on," "directly mounted," "directly connected," or "directly coupled," there are no intervening elements present. Other terms used to describe relationships between elements (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.) should be interpreted similarly.

[0076] It will be further understood that when a first element is described as being "in," "on," and / or "within" a second element, the first element may be located within the interior space of the second element, located within a portion of the second element (e.g., within a wall of the second element), located on the exterior and / or interior surface of the second element; and combinations of one or more of these.

[0077] Spatially relative terms, such as "below," "below," "low," "above," "high," and similar terms, may be used to describe the relationship of an element and / or feature to another element and / or feature, e.g., as illustrated. It will be understood that the spatially relative terms are intended to encompass various orientations of the device in use and / or operation in addition to the orientation as illustrated. For example, if the device is inverted in the drawings, elements described as "below" and / or "below" other elements or features would then be oriented "above" the other elements or features. The elements may be in other orientations (e.g., rotated 90 degrees or at other angles), and the spatially relative language used herein would be interpreted appropriately.

[0078] The term "and / or," as used herein, should be construed as referring to each feature of two specified features or elements together with or apart from the other. For example, "A and / or B" refers to the disclosure of (i) A, (ii) B, and (iii) each of A and B, each of which should be understood as being individually disclosed herein.

[0079] "Room pressure," as described herein, refers to the pressure in the environment surrounding the systems and devices of the inventive concepts. Positive pressure includes a pressure greater than room pressure or greater than another pressure, e.g., a positive pressure differential across an element of the fluid path, such as a valve. Negative pressure includes a pressure less than room pressure or less than another pressure, e.g., a negative pressure differential across an element of the fluid path, such as a valve. Negative pressure may include a vacuum, but does not mean a pressure less than a vacuum. As used herein, the term "vacuum" refers to a full or partial vacuum, or any negative pressure described herein.

[0080] The term "diameter," when used herein to describe non-circular shapes, should be interpreted as the diameter of an imaginary circle that approximates the described shape. For example, when describing a cross-section, e.g., the cross-section of an element, "diameter" should be interpreted to mean the diameter of an imaginary circle having the same cross-sectional area as the cross-sectional area of ​​the described element.

[0081] The terms "major axis" and "minor axis" of an element, as used herein, refer to the length and diameter, respectively, of the smallest volume imaginary cylinder that can completely enclose the element.

[0082] The term "transducer," as used herein, should be interpreted to mean any element or combination of elements that accepts energy or any input and provides an output. For example, a transducer can receive electrical energy and distribute the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as light (e.g., the transducer comprises a light-emitting diode or a light bulb), sound (the transducer comprises a piezoelectric crystal configured to deliver ultrasound energy), pressure, heat energy, cryogenic energy, chemical energy, mechanical energy (e.g., the transducer comprises a motor or solenoid), magnetic energy, and / or various electrical signals (e.g., Bluetooth or other wireless communication elements). Alternatively or additionally, a transducer can convert a physical quantity (e.g., a variation in a physical quantity) into an electrical signal. Transducers may include any element that delivers energy and / or agents to tissue, including, for example, those configured to deliver electrical energy to tissue (e.g., a transducer comprising one or more electrodes), those configured to deliver optical energy to tissue (e.g., a transducer comprising a laser, a light emitting diode, and / or an optical element such as a lens or prism), those configured to deliver mechanical energy to tissue (e.g., a transducer comprising a tissue actuation element), those configured to deliver acoustic energy to tissue (e.g., a transducer comprising a piezoelectric crystal), those configured to deliver chemical energy, those configured to deliver electromagnetic energy, those configured to deliver magnetic energy, and one or more combinations thereof.

[0083] The term "patient site," as used herein, means a location within a patient, for example, a location within a bodily conduit such as a blood vessel (e.g., an artery or vein, such as an artery or vein of the heart), or a segment of the digestive tract (e.g., the esophagus, stomach, or intestines), or a location within an organ. "Patient site" can also refer to a location within the spine, for example, within the epidural space or intrathecal space. Patient sites can include locations containing one or more of an aneurysm, a stenosis, a thrombus, and / or an implant.

[0084] The term "neural site," as used herein, means a patient site proximal to the brain, such as a site within the patient's neck, head, or brain. A neural site can include a site proximal to the brain, for example, one or more of an aneurysm, a stenosis, a thrombus, and / or an implant.

[0085] The term "proximal," as used herein, includes a location relatively close to, on, in, and / or within the element to which it refers or another location.

[0086] The terms "transparent" and "optically transparent," as used herein, refer to the property of a material being relatively transparent (e.g., not opaque) to light provided and / or collected by one or more elements of an imaging system or probe based on the concepts of the present invention (e.g., to collect image data of a patient site).

[0087] Although certain features of the inventive concepts are described in the context of separate embodiments for clarity, it will be understood that they may also be used in combination in a single embodiment. Conversely, various features of the inventive concepts are described in the context of a single embodiment for clarity, but they may also be used independently or in any suitable subcombination. For example, it will be understood that all features recited in the claims (whether independent or dependent) may be combined in any desired manner.

[0088] The present concepts include imaging systems comprising an imaging probe (e.g., an optical imaging probe) and / or one or more delivery devices (e.g., a delivery catheter and / or a guidewire). The imaging probe can be configured to be positioned proximate to a patient site (as defined above) to collect image data from the patient site (e.g., a neural site, a spinal site, a cardiac site, and / or other patient site). The imaging probe comprises an elongate shaft including a lumen. In certain embodiments, a rotatable optical core and a distally disposed optical assembly are disposed within the lumen of the probe shaft. The present concepts further include methods of introducing the imaging probe into a patient site, e.g., a neural site or a cardiac site, using one or more delivery devices, such as a delivery catheter and / or a guidewire. In certain embodiments, the imaging probe is advanced through a delivery catheter to the patient site without advancing the imaging probe using a guidewire.

[0089] Referring to FIG. 1, a schematic diagram of an imaging system according to the concepts of the present invention is shown, comprising an imaging probe and one or more delivery devices. System 10 is constructed and arranged to collect image data and form an image based on the recorded data, such as in the case of an Optical Coherence Tomography (OCT) imaging system. System 10 comprises imaging probe 100 and at least one delivery catheter, e.g., at least one delivery catheter 50 and / or at least one guidewire 60. System 10 may comprise console 200 configured to be operably attached to the imaging probe. System 10 may further comprise a fluid injector, such as injector 300, that can be configured to inject one or more fluids, e.g., flushing fluid, imaging contrast agent (e.g., radiopaque contrast agent, hereinafter referred to as "contrast agent"), and / or other fluids (e.g., injectate 305 as shown). System 10 may further comprise an implant, such as implant 85, that can be placed in the patient via implant delivery device 80. System 10 may further comprise a device configured to treat the patient, treatment device 91, which may be configured to dilate a stenosis, remove stenotic material (e.g., a thrombus), and / or treat a disease or disorder in the patient. System 10 may further comprise a second imaging device, such as imaging device 92, as shown.

[0090] Imaging probe 100 comprises an elongate shaft, shaft 110, having a proximal end 111, a distal end 119, an intermediate section 110, and a distal section 118. Disposed at proximal end 111 of shaft 110 is a connector, connector 102, for example, a connector configured to operably attach probe 100 to console 200. Imaging probe 100 is configured to provide images of a patient (e.g., a three-dimensional image formed upon retraction of shaft 119 of imaging probe 100). In certain embodiments, elements of imaging probe 100 and / or system 10 are similar in construction and arrangement to like elements described in applicant's co-pending U.S. Provisional Application No. 62 / 148,355, filed April 29, 2015, entitled "Micro-Optic Probes for Neurology," the entire contents of which are hereby incorporated by reference.

[0091] The imaging probe 100 is configured and positioned to collect image data from a patient site, such as the patient site PS shown in Figures 5, 6A-E, 7A-E, 8A-D, 9A-C, 10A-E, or 12. In these embodiments, the distal portion 118 can be configured to pass through a patient site, such as a patient site containing occlusive material, such as a thrombus, or a patient site containing an implant. In some embodiments, the probe 100 is configured and positioned to collect image data from a neural site, such as a neural site selected from the group consisting of an artery in the patient's neck; a vein in the patient's neck; an artery in the patient's head; a vein in the patient's head; an artery in the patient's brain; a vein in the patient's brain; and one or more combinations thereof. In some embodiments, the probe 100 is configured and positioned to collect image data from a cardiac site, such as a cardiac site selected from the group consisting of an artery in the heart, a vein in the heart, an atrium in the heart, a ventricle in the heart; and one or more combinations thereof. In some embodiments, the probe 100 is configured and positioned to collect image data from along or near the patient's spine. In certain embodiments, probe 100 is configured and positioned to collect image data from tissue selected from the group consisting of wall tissue of a blood vessel at the patient site, a thrombus near the patient site, occlusive material at the patient site, a blood vessel outside the blood vessel in which optical assembly 130 is placed, tissue outside the blood vessel in which optical assembly 130 is placed, extracellular deposits outside the lumen of the blood vessel in which optical assembly 130 is placed (e.g., inside and / or outside the blood vessel wall), and one or more combinations thereof. Alternatively or additionally, optical assembly 130 can be configured and positioned to collect image data from a placed (or implanted) device (e.g., a temporary or chronically placed device), such as implant 85 described below, or a device pre-placed in the patient. In certain embodiments, optical assembly 130 is configured and positioned to collect image data in connection with a placement procedure in which an implant is placed in a patient (e.g., real-time data collected during placement).The optical assembly 130 is configured and positioned to collect implant data, including position and / or deployment data, regarding the placement of an implant or other treatment device, such as a device selected from the group consisting of a stent retriever (also known as a "stentriever"), an embolic device such as an embolic coil, an occlusion device, a flow diverter, and one or more combinations thereof. In certain embodiments, the optical assembly 130 is configured and positioned to collect data regarding the placement of an implant 85 or other device comprising a stimulation element, such as an electrode or other stimulation element positioned near the brain (e.g., an electrode positioned deep in the brain or at another brain location) or a stimulation element positioned near the spine (e.g., a stimulation element configured to treat the spine by stimulating spinal tissue). The implantation of the implant 85 can be performed based on an analysis of the collected data (e.g., an algorithmic analysis of the collected data). The analysis can be used to modify placement parameters selected from the group consisting of: selection of a deployable device (e.g., selection of implant 85), selection of a porosity of the deployable device, selection of coverage of the deployable device (e.g., the percentage of the vessel surface area covered by the metal or other material of the deployable device), selection of a pore density of the deployable device, selection of a diameter of the deployable device, selection of a length of the deployable device, selection of a location to place the deployable device, expansion parameters of the deployable device once deployed, repositioning of the deployable device once deployed, selection of a second implant to be placed, and combinations thereof. Adjustments to the placement can be made based on one or more factors identified by the analysis, such as one or more factors selected from the group consisting of misplacement of the implant device, improper deployment of the implant device, the presence of air bubbles, and combinations thereof.

[0092] In one embodiment, optical assembly 130 is configured and arranged to collect data regarding the position of a treatment device, such as treatment device 91, described below, during a patient treatment procedure.

[0093] The delivery catheter 50 may comprise one or more delivery catheters, such as the illustrated delivery catheters 50a, 50b, 50c-50n. The delivery catheters 50 are as follows: the delivery catheter 50a shown in FIG. 1 acts as a vascular introducer; INTRO Other delivery catheters 50 may include a vascular introducer, such as one comprising a vascular introducer. After the vascular introducer is placed through the patient's skin, delivery catheter 50 INTRO Two or more delivery catheters 50 may collectively have a set of inner diameters (ID) and outer diameters (OD), such that a first delivery catheter 50 slidingly receives a second delivery catheter (e.g., the outer diameter of the second delivery catheter is less than or equal to the inner diameter of the first delivery catheter), a second delivery catheter 50 slidingly receives a third delivery catheter (e.g., the outer diameter of the third delivery catheter is less than or equal to the inner diameter of the second delivery catheter), etc. In these embodiments, progressively smaller diameter delivery catheters 50 may be used to advance a first delivery catheter 50 to a first anatomical location, advance a second delivery catheter 50 through the first delivery catheter to a second anatomical location or a second anatomical location distal to or remote from the first anatomical location, etc., as appropriate.

[0094] Each delivery catheter 50 comprises a shaft 51 (e.g., shafts 51a, 51b, 51c, and 51n as shown), each shaft having a distal end 59 (e.g., distal ends 59a, 59b, 59c, and 59n as shown). A connector 55 (e.g., connectors 55a, 55b, 55c, and 55n as shown) is disposed at the proximal end of each shaft 51n. Each connector 55 may comprise a Touhy or other valved connector, such as a valved connector configured to prevent fluid from exiting the associated catheter 50 (with or without another shaft disposed within connector 55). Each connector 55 may comprise a port 54, such as ports 54b, 54c, and 54n (e.g., ports 54b, 54c, and 54n as shown disposed on delivery catheters 50b, 50c, and 50n), configured to introduce fluid from and / or remove fluid from the associated catheter 50. In certain embodiments, as described below, flushing fluid is introduced through one or more ports 54, such as to remove blood or other undesirable material from the vicinity of optical assembly 130. Ports 54 may be located to the side of connector 55 and may have a luer fitting and a cap and / or valve. Shaft 51, connector 55, and ports 54 may each be constructed of standard materials and may be similar in structure to commercially available introducers, guide catheters, diagnostic catheters, midpoint catheters, and microcatheters used in interventional procedures.

[0095] Each delivery catheter comprises a lumen 52 (reference number 52 shown on delivery catheter 50a but omitted from the remaining delivery catheters for simplicity) extending from connector 55 to the distal end 59 of shaft 51. The diameter of each lumen 52 defines the inner diameter of the associated delivery catheter 50. Each delivery catheter 50 can be advanced over a guidewire (e.g., guidewire 60) via lumen 52. In some embodiments, delivery catheter 50 is configured for rapid exchange advancement and retraction over a guidewire in a sidecar manner, as described below with reference to FIG. 4B. In some embodiments, the probe 100 and at least one delivery catheter 50 are cooperatively configured and arranged so that the delivery catheter 50 is advanced through a vessel, such as a blood vessel, and the probe 100 is slidingly received by the delivery catheter 50 and advanced through the delivery catheter 50 to a location near the patient site PS to be imaged (e.g., just distal to, within, and / or just proximal to the patient site PS to be imaged). In some embodiments, a second delivery catheter 50 is slidingly received by the first delivery catheter 50, and the probe 100 is advanced through the second delivery catheter 50 to a location near the patient site PS to be imaged. In yet other embodiments, three or more delivery catheters 50 are coaxially inter-inserted, and the probe 100 is advanced through the innermost delivery catheter 50 to the patient site PS to be imaged. In some embodiments, the probe 100 is advanced through (e.g., through and beyond) one or more delivery catheters 50 without the use of a guidewire.

[0096] The delivery catheter 50 may comprise one or more delivery catheters selected from the group consisting of introducers, vascular introducers, delivery catheters (also called guide catheters) for placement through the aortic arch (e.g., with its distal end located just distal or proximal to the aortic arch), such as an introducer having an inner diameter of 7 French to 9 French, a delivery catheter having an inner diameter of 5 French to 7 French or about 6.5 French, a delivery catheter (also called an intermediate catheter) for insertion through a larger, previously placed delivery catheter, such as an intermediate delivery catheter having an inner diameter of 0.053 inches to 0.070 inches, a delivery catheter (also called a microcatheter) having an inner diameter of 0.0165 inches to 0.027 inches, and combinations of one or more of these. In one embodiment, the delivery catheter 50 comprises a first delivery catheter 50 having an introducer, such as an introducer having an inner diameter of 7 French to 9 French or about 8 French. INTRO The delivery catheter 50 is configured for placement through the aortic arch having an inner diameter of 5 Fr to 7 Fr or an inner diameter of approximately 6.5 Fr. GUIDE The delivery catheter 50 may further comprise a second delivery catheter configured and positioned to be inserted within the first delivery catheter, such as a third delivery catheter 50 having an inner diameter of 0.053 inches to 0.070 inches. INTER As shown in the figure, the first delivery catheter 50 INTRO and / or a second delivery catheter 50 GUIDE The delivery catheter 50 may comprise a fourth delivery catheter 50 having an inner diameter of 0.0165 inches to 0.027 inches. MICRO a fourth delivery catheter 50 configured and arranged for insertion through the first delivery catheter, the second delivery catheter, and / or the third delivery catheter 50, as described above; MICROThe imaging probe 100 may be configured and arranged for insertion through the first, second, third, and / or fourth delivery catheters 50 when the imaging probe 100 has an outer diameter less than 0.070 inches, e.g., when at least a distal portion of the imaging probe 100 has an outer diameter equal to or less than 0.025 inches, 0.022 inches, 0.018 inches, 0.016 inches, 0.015 inches, or 0.014 inches. In some embodiments, at least a distal portion of the imaging probe 100 has an inner diameter of about 0.014 inches (e.g., an inner diameter between 0.012 inches and 0.016 inches). In some embodiments, the system 10 comprises the probe 100 and one or more delivery catheters 50, as described below with reference to FIG. 2 or FIG. 5.

[0097] Each delivery catheter 50 may comprise an optically transparent segment, such as a segment relatively transparent to light transmitted and / or received by optical assembly 130, such as transparent segment 57 shown in delivery catheter 55n and described herein. Transparent segment 57 may have a length of up to 50 cm, such as a length of 1 cm to 15 cm, or up to 2 cm, or up to 5 cm.

[0098] Each delivery catheter 50 may comprise a spring tip, not shown, such as spring tip 104 described herein as being attached to shaft 110 of probe 100 .

[0099] Guidewire 60 may comprise one or more guidewires, such as guidewires 60a, 60b, through 60n, configured and positioned to support advancement (e.g., intravascular advancement) of probe 100 (e.g., via a rapid exchange lumen in distal portion 118 of shaft 110) and / or a delivery catheter to a patient site PS, such as a neural site or a cardiac site. The guidewire 60 may be a guidewire having an outer diameter of 0.035 inches to 0.038 inches, a guidewire having an outer diameter of 0.010 inches to 0.018 inches, a guidewire having an access length, such as a guidewire having a length of about 200 cm, a guidewire having an exchange length, such as a guidewire having a length of about 300 cm, a guidewire having a length of 175 cm to 190 cm, a guidewire having a length of 200 cm to 300 cm and / or an outer diameter of 0.014 inches to 0.016 inches, a hydrophilic guidewire, a Stryker Synchro™ guidewire, a Terumo guidewire (e.g., a Terumo Glidewire™ guidewire), a Terumo The system 10 may comprise one or more guidewires selected from the group consisting of a Traxcess™ guidewire, an X-Celerator™ guidewire, an X-Pedion™ guidewire, an Agility™ guidewire, a Bentson™ guidewire, a Coon™ guidewire, an Amplatz™ guidewire, and combinations of one or more of the foregoing. In certain embodiments, the system 10 comprises a probe 100 and one or more guidewires 60, as described below with reference to FIG. 2 or FIG. 5. The guidewire 60 may comprise one or more visualizeable portions, such as a radiopaque or ultrasound reflective portion.

[0100] The system 10 may comprise various combinations and configurations of delivery catheters 50 and guidewires 60. In one embodiment, the delivery catheter 50 comprises a first delivery catheter 50 having an introducer (e.g., a vascular introducer). INRTO and a delivery catheter 50 INTRO The delivery catheter 50 may comprise at least two delivery catheters 50 inserted through the guidewire 60, the catheters having various combinations of inner and outer diameters, each of which may be inserted sequentially through the lumen 52 of a previously placed delivery catheter 50, e.g., as described in detail herein. In some embodiments, a first delivery catheter 50 is advanced over a first guidewire 60, followed by an additional delivery catheter 50 of a smaller outer diameter advanced over the guidewire 60 (e.g., after removing the first guidewire 60 from the first delivery catheter 50 and replacing it with a second guidewire 60). In some embodiments, after image data is collected with an imaging probe 100 positioned within the delivery catheter (e.g., after pullback to collect image data), the imaging probe 100 is removed and replaced with the guidewire 60. Additional devices (e.g., another delivery catheter 50, a treatment device 91, an implant delivery device 80, or other devices) may be placed over the guidewire 60. In one embodiment, the probe 100, one or more delivery catheters 50, and / or one or more guidewires 60 are inserted, advanced, and / or withdrawn as described below with reference to Figures 2, 5, 6A-E, 7A-E, 8A-D, 9A-C, or 10A-E.

[0101] Instead of advancing the probe 100, one or more delivery catheters 50 and / or one or more guidewires 60 through one or more blood vessels (e.g., advancing one or more delivery catheters 50 over a guidewire 60 through one or more arteries or veins), one or more of these devices can be advanced to the patient site PS through a lumen other than a blood vessel (e.g., as can also be done over a guidewire 60), such as the epidural space and / or the intrathecal space of the spine, or through another body lumen or cavity.

[0102] In one embodiment, one or more delivery catheters 50 comprise functional elements 53 (e.g., functional elements 53a, 53b, 53c, and 53n as shown). Each functional element 53 may comprise one or more functional elements, such as one or more sensors, transducers, and / or other functional elements, as described in more detail below.

[0103] 1A, an enlarged view of distal portion 118 is shown in accordance with the concepts of the present invention. Lumen 112 extends from proximal end 111 of shaft 110 to distal portion 118, terminating at a point proximal to distal end 119. Located within lumen 112 is a rotating optical core, core 120. An optical assembly, optical assembly 130, is located at the distal end of core 120. Optical assembly 130 includes a surface 131 located within an optically translucent and / or effectively transparent portion, viewing portion 117, of shaft 110. Optical assembly 130 is configured and arranged to collect image data through at least a portion of shaft 110 (e.g., viewing portion 117). In certain embodiments, optical assembly 130 is further configured and arranged to collect image data through at least a portion of an additional device, for example, through at least a portion of the shaft of delivery catheter 50 (e.g., an optically transparent portion of delivery catheter 50, such as transparent segment 57, as described herein). Connector 102 can be rotatably attached to core 120 (e.g., to allow core 120 to rotate relative to one or more portions of connector 102 while preventing longitudinal movement of core 120 relative to connector 102). In certain embodiments, connector 102 is fixedly attached to shaft 110 to prevent all relative movement between shaft 110 and core 120, such as preventing longitudinal movement between them (e.g., as when shaft 110 and optical assembly 130 are retracted together while collecting image data, as described herein).

[0104] In some embodiments, lumen 112 (e.g., in the space not occupied by core 120 and optical assembly 130) contains fluid 190, such as fluids 190a and 190b shown in FIG. 1A. Fluid 190 (e.g., fluid 190b) can be an optically transparent fluid. In some embodiments, fluid 190a and fluid 190b are similar substances. Alternatively or additionally, fluid 190a and fluid 190b can be dissimilar substances. In some embodiments, fluid 190a is a more viscous fluid than fluid 190b. Fluid 190 can be constructed and arranged to limit undesirable fluctuations in the rotational speed of core 120 and / or optical assembly. In some embodiments, fluid 190 is a non-Newtonian fluid or other fluid whose viscosity changes with shear. In one embodiment, lumen 112 includes a seal, with sealing element 116 configured and arranged to provide a seal between optical core 120 and the wall of shaft 110. Sealing element 116 allows rotation of optical core 120 while preventing mixing and / or movement of fluids 190a and 190b.

[0105] Shaft 110 may be made of one or more materials and may have at least a portion braided. In some embodiments, at least a distal portion 118 of shaft 110 has an outer diameter less than or equal to 0.025 inches, such as less than or equal to 0.022 inches, 0.018 inches, 0.016 inches, 0.015 inches, or 0.014 inches. In some embodiments, shaft 110 is made of a material selected from the group consisting of polyetheretherketone (PEEK), polyimide, nylon, fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyether block amide (Pebax), and combinations of one or more thereof. In some embodiments, shaft 110 has at least a portion comprising a braid comprising stainless steel and / or a nickel-titanium alloy, e.g., shaft 110 comprises a braid disposed on a thin wall of FEP or PTF. The blade portion may be covered with Pebax or other flexible material.

[0106] The viewing portion 117 of the shaft 110 may be made of one or more materials, and may be made of similar or dissimilar materials for different portions of the shaft 110. The viewing portion 117 may have an inner diameter and / or outer diameter similar to one or more other portions of the shaft. In some embodiments, the viewing portion 117 has an inner diameter and / or outer diameter that is larger than the inner diameter and / or outer diameter of the shaft 110 at the intermediate portion 115 of the shaft. The viewing portion 117 may be made of one or more optically transparent materials selected from the group consisting of Pebax, amorphous PEEK, polyimide, glass, sapphire, and combinations of one or more of these.

[0107] In one embodiment, a flexible tip portion, such as spring tip 104 as shown, is disposed at the distal end of shaft 110. Spring tip 104 may have a length of 0.5 cm to 5 cm, such as about 1 cm, 2 cm, or 3 cm. At least a portion of spring tip 104 can be made visible to imaging equipment, for example, by including a radiopaque material, such as platinum, which is visible to x-ray imaging devices.

[0108] The console 200 comprises a rotation assembly 210 configured and arranged to rotate the assembly, at least the rotatable optical core 120. The console 200 may comprise a pullback assembly 220 configured and arranged to pull back the assembly, the shaft 110 and / or the optical assembly 130. In some cases, the pullback assembly 220 and the probe 100 can be configured such that the pullback assembly 220 pulls back the optical assembly 130 and the shaft 110 together during image data acquisition. In these embodiments, because the optical assembly 130 does not move within the shaft 110, the shaft 110 may comprise a relatively short viewing window, the viewing portion 117, surrounding the optical assembly 130. For example, in these embodiments, the viewing portion 117 has a length less than or equal to 20 mm, less than or equal to 15 mm, less than or equal to 6 mm, or less than or equal to 4 mm, such as when the viewing portion 117 has a length of about 3 mm. In those embodiments in which the viewing portion 117 has a relatively short length, the viewing portion 117 may be made of a material that is softer and / or more flexible than the rest of the shaft 110 (e.g., without significantly affecting the column and / or torsional strength of the probe 100). In some embodiments, the viewing portion 117 may have a length of 5 mm to 50 mm, such as a length of about 10 mm or about 12 mm. In those embodiments in which the optical assembly 130 does not move within the shaft 110, the diameter (inner and / or outer diameter) of the shaft 110 may be reduced in a location near the viewing portion 117, such as when (for at least that portion of the shaft 110 surrounding and adjacent the optical assembly) the diameter is less than or equal to 0.025 inches, less than or equal to 0.016 inches, or less than or equal to 0.014 inches.Alternatively or additionally, in those embodiments in which the optical assembly 130 does not move within the shaft 110, a portion of the shaft proximal to the optical assembly 130 (e.g., proximal to the observation portion 117) may have an opaque structure, such as a braided structure or a structure using a material such as a metal tube (e.g., a nitinol or stainless steel hypotube), to, for example, improve the pushability of the probe 100. The rotation assembly 210 and / or the pullback assembly 220 may be similar in configuration and arrangement to those described below with reference to FIG. 13 . The console 200 may comprise an imaging assembly 230 configured to provide light to and collect light from the optical assembly 130 (e.g., via the core 120). The light source 231 may comprise one or more light sources, such as one or more light sources configured to provide light of one or more wavelengths to the optical assembly 130 via the core 120. The light source 231 is configured to provide light to the optical assembly 130 (via the core 120) so that image data can be collected, including cross-sectional, longitudinal, and / or three-dimensional information about the patient site PS to be imaged or the positioned device. The light source 231 can be configured to provide light to quantify, qualify, or otherwise provide information about a patient disease or disorder present within the patient site PS to be imaged, such that the collected image data includes tissue characteristics within the patient site PS to be imaged. The light source 231 can be configured to transmit broadband light having a center wavelength in the range of 800 nm to 1700 nm, in the range of 1280 nm to 1310 nm, or at approximately 1300 nm (e.g., propagating light having a sweep range of 1250 nm to 1350 nm). The bandwidth of the light source 231 can be selected to achieve a desired resolution, which can vary depending on the requirements of the intended use of the system 10. In one embodiment, the bandwidth is approximately 5% to 15% of the center wavelength, thereby enabling a resolution of 5 microns to 20 microns. The light source 231 can be configured to transmit a level of power that meets ANSI Class 1 (eye-safe) standards, although higher power levels can also be used.In one embodiment, light source 231 transmits light in the 1.3 micrometer band at a power level of approximately 20 mA. Increasing the center wavelength of the transmitted light reduces scattering of light by tissue but increases water absorption. Light source 231 can transmit light at a wavelength of approximately 1300 nm to balance these two effects. Light source 231 can be configured to transmit light at a shorter wavelength (e.g., approximately 800 nm) to traverse a patient region to be imaged that contains a large amount of fluid. Alternatively or additionally, light source 231 can be configured to transmit light at a longer wavelength (e.g., approximately 1700 nm) to, for example, reduce high levels of scattering within the patient region to be imaged.

[0109] The rotating assembly 210 can be configured and arranged to rotate the core 120 (and subsequently one or more elements of the optical assembly 130) at a rotational speed of approximately 250 rps, or at a rotational speed of 40 rps to 1000 rps. In certain embodiments, the rotating assembly 210 is configured and arranged to rotate the core 120 at one speed (e.g., at least 50 rps or approximately 250 rps) during image data collection (i.e., "imaging mode") and at a different speed (e.g., a slower speed, e.g., 30 rps to 150 rps) during "preview mode." During preview mode, a "positioning maneuver" can be performed to linearly position the optical assembly 130 and / or initiate a flash procedure. The positioning maneuver can be configured to visualize glare (e.g., through one or more implants, e.g., deployed stents, flow directors, and / or coils). Alternatively, or in addition, the preview mode allows an operator (e.g., a physician) to confirm that the optical assembly 130 has exited the distal end 59 of the surrounding delivery catheter 50. The preview mode can be configured to reduce the time and acceleration forces associated with rotating the core 120 at a speed compatible with collecting image data (e.g., a rotational speed of at least 150 rps or about 250 rps).

[0110] The pullback assembly 220 can be configured and arranged to pull back the optical assembly 130 (e.g., by pulling back the shaft 100) at a pullback rate of about 40 mm / sec, e.g., a pullback rate of 5 mm / sec to 60 mm / sec. The pullback assembly 220 can be configured and arranged to perform a pullback of 20 mm to 100 mm, such as for a pullback time of 1.0 second to 15.0 seconds.

[0111] Console 200 may comprise a display 250, e.g., a display configured to provide one or more images (e.g., videos) based on collected image data. Imaging assembly 230 may be configured to provide images to display 250 at an updated frame rate of up to about 250 frames per second (e.g., similar to the rotational speed of core 120). Display 250 may provide two-dimensional or three-dimensional images of two-dimensional or three-dimensional data.

[0112] Console 200 may comprise one or more functional elements, such as functional element 203 of Figure 1. Functional element 203 may comprise one or more functional elements, such as one or more sensors, transducers, and / or other functional elements, as described in more detail below.

[0113] Console 200 may comprise an algorithm, such as illustrated algorithm 240, that may be configured to adjust (e.g., automatically and / or semi-automatically) one or more operational parameters of system 10, such as the operational parameters of console 200, probe 100, and / or delivery catheter 50. Alternatively or additionally, algorithm 240 may be configured to adjust operational parameters of another device, such as injector 300 or implant delivery device 80, described below. In certain embodiments, algorithm 240 is configured to adjust operational parameters based on one or more sensor signals, such as sensor signals provided by functional elements of a sensor system of the present concepts, described below (e.g., signals provided by one or more functional elements 53, 83, 93, 103, 203, 303). The algorithm 240 can be configured to adjust operating parameters selected from the group consisting of rotational parameters, such as the rotational speed of the core 120 and / or the optical assembly 130; pullback parameters of the shaft 110 and / or the optical assembly 130, such as the pullback speed, distance, start point, end point, and / or pullback initiation timing (e.g., when to start pullback); positional parameters, such as the position of the optical assembly 130; line spacing parameters, such as the number of lines per frame; image display parameters, such as scaling of display size relative to vessel diameter; structural parameters of the probe 100; parameters of the injectate 305, such as a saline-to-saline contrast ratio configured to determine an appropriate refractive index; light source 231 parameters, such as the power of transmitted light and / or the frequency of transmitted light; and combinations of one or more of these.In some embodiments, algorithm 240 is configured to adjust pullback parameters, e.g., parameters that trigger the initiation of pullback, such as based on parameters selected from the group consisting of: lumen cleanliness; an injector 300 signal; a change in collected image data (e.g., a change in the image based on the collected image data that correlates to adequate removal of blood from around optical assembly 130); and one or more combinations thereof. In some embodiments, algorithm 240 adjusts structural parameters of probe 100, such as by identifying (automatically via RF or other embedded ID) the probe 110 to which algorithm 240 is attached and adjusting the arm path length and / or other parameters mentioned above.

[0114] The injector 300 may comprise a power injector, automatic injector, peristaltic pump, or other fluid delivery device configured to inject contrast media, e.g., radiopaque contrast media, and / or other fluids (e.g., contrast media, saline, and / or dextran). In some embodiments, the injector 300 delivers fluids in flushing procedures, as described below. In some embodiments, the injector 300 delivers contrast media or other fluids through a delivery catheter 50 having an inner diameter of 5 French to 9 French, a delivery catheter 50 having an inner diameter of 0.053 inches to 0.070 inches, or a delivery catheter 50 having an inner diameter of 0.0165 inches to 0.027 inches. In some embodiments, the contrast media or other fluids are delivered through a delivery catheter as small as 4 French (e.g., for distal injection). In some embodiments, the injector 300 delivers contrast and / or other fluids through the lumen of one or more larger delivery catheters 50, with one or more delivery catheters 50 present in the lumen. In some embodiments, the injector 300 is configured to deliver two dissimilar fluids simultaneously and / or sequentially, such as delivering a first fluid containing a first concentration of contrast from a first reservoir and a second fluid containing a lesser concentration or no contrast from a second reservoir. The injector 300 may comprise one or more functional elements, such as the functional element 303 shown in FIG. 1. The functional element 303 may comprise one or more functional elements, such as one or more sensors, transducers, and / or other functional elements described in more detail below.

[0115] Implant 85 may be an implant (e.g., a temporary or long-term placement implant) that treats one or more vascular occlusions or aneurysms. In some cases, implant 85 is one or more implants selected from the group consisting of a flow diverter; a Pipeline™ flow diverter; a Surpass™ flow diverter; an embolic coil; a stent; a Wingspan™ stent; a covered stent; an aneurysm treatment implant; and one or more combinations thereof. Delivery device 80 may comprise a catheter or other tool used to deliver implant 85, such as when implant 85 comprises a self-expanding or balloon-expandable portion. Implant delivery device 80 may comprise a functional element, such as functional element 83 shown in FIG. 1 . Functional element 83 may comprise one or more functional elements, such as one or more sensors, transducers, and / or other functional elements, as described in more detail below. In one embodiment, system 10 comprises probe 100, one or more implants, and / or one or more implant delivery devices 80, which are described in more detail below with reference to Figure 5. In one embodiment, probe 100 is configured to collect data regarding implant 85 and / or implant delivery device 80 (e.g., anatomical location, orientation, and / or structural data of implant 85 and / or implant delivery device 80) after inserting implant delivery device 80 into a patient.

[0116] The treatment device 91 may be an occlusion treatment device or other treatment device selected from the group consisting of a balloon catheter configured and positioned to open a stenosis or other narrowed portion of a blood vessel; a drug-eluting balloon; an aspiration catheter; a sonolysis device; an atherectomy device; a thrombus removal device, such as a stent retriever device; a Trevo™ stentreaver; a Solitaire™ stentreaver; a Revive™ stentreaver; an Eric™; a Lazarus™ stentreaver; a stent delivery catheter; a microblade implant; an embolization system; a WEB™ embolization system; a Luna™ embolization system; a Medina™ embolization system; and one or more combinations thereof. In certain embodiments, the probe 100 is configured to collect data regarding the treatment device 91 (e.g., the position, orientation, and / or other structural data of the treatment device 91) after the treatment device 91 is inserted into the patient. Treatment device 91 may comprise functional elements such as functional element 93 shown in FIG.

[0117] The second imaging device 92 may comprise one or more imaging devices selected from the group consisting of: X-ray; fluoroscope, e.g., single- or two-way fluoroscope; CT scanner; MRI; PET scanner; ultrasound imaging device; and combinations of one or more of these.

[0118] Functional elements 53, 83, 93, 103, 113, 203 and / or 303 may each comprise one or more sensors, transducers and / or other functional elements as described in more detail below.

[0119] In some embodiments, functional element 113 is located proximate to optical assembly 130 (e.g., distal to optical assembly 130 as shown in FIG. 1A, coaxial with optical assembly 130, and / or proximal to optical assembly 130). In some embodiments, imaging probe 100 has functional element 103 as shown in FIG. 1. Functional element 103 is shown as being located at a proximal portion of shaft 110, but may be located at another location on probe 100, such as on, in, and / or within connector 102. Functional elements 103 and / or 113 may each be one or more functional elements, such as sensors, transducers, and / or other functional elements, as described in more detail below.

[0120] In certain embodiments, functional elements 53, 83, 93, 103, 113, 203, and / or 303 comprise sensors, such as sensors configured to provide signals related to parameters of elements of system 10 and / or sensors configured to provide signals related to parameters of the patient. Functional elements 53, 83, 93, 103, 113, 203, and / or 303 may comprise one or more sensors selected from the group consisting of: physiological sensors; pressure sensors; strain gauges; position sensors; GPS sensors; accelerometers; temperature sensors; magnetic sensors; chemical sensors; biochemical sensors; protein sensors; flow sensors, e.g., ultrasonic flow sensors; gas detection sensors, e.g., ultrasonic bubble detectors; acoustic sensors, e.g., ultrasonic sensors; and combinations of one or more of these. In some embodiments, functional elements 53, 83, 93, 103, 113, 203, and / or 303 may comprise one or more physiological sensors selected from the group consisting of a pressure sensor, e.g., a blood pressure sensor; a blood gas sensor; a flow sensor, e.g., a blood flow sensor; a temperature sensor, e.g., a blood or other tissue temperature sensor; and one or more combinations thereof. In some embodiments, algorithm 240 is configured to process signals received by the sensors, such as signals provided by sensors described herein. In some embodiments, functional elements 53, 83, 93, 103, and / or 113 comprise position sensors configured to provide signals related to a vascular path (e.g., a vascular lumen path) in three dimensions. In some embodiments, functional elements 53, 83, 93, 103, and / or 113 comprise magnetic sensors configured to provide signals for positioning optical assembly 130 relative to one or more positioned devices (e.g., one or more implants 85 having iron or other magnetic ⊃ described herein). In certain embodiments, functional elements 53, 83, 93, 103 and / or 113 comprise a flow sensor, e.g., a flow sensor configured to provide a signal related to blood flow within a blood vessel at patient site PS (e.g., blood flow through a stenosis or other partially occluded segment of a blood vessel).In these embodiments, algorithm 240 can be configured to assess blood flow (e.g., assess the degree of obstruction), e.g., to provide information to a physician regarding potential treatment for the stenosis. In some embodiments, optical assembly 130 comprises functional element 113, e.g., where optical element 130 is configured and arranged as a sensor to provide a signal related to blood flow. In some embodiments, functional elements 53, 83, 93, 103, and / or 113 comprise a flow sensor configured to provide a signal used to co-register flow data with vascular anatomical data, which can be used to model pre- and post-treatment flow (e.g., aneurysmal flow), assess risk of rupture, and / or provide other assessments of the adequacy of treatment. In some embodiments, functional elements 53, 83, 93, 103, and / or 113 comprise an ultrasound sensor configured to provide a signal (e.g., image or frequency data) that can be co-registered with near-field optics-derived information provided by optical sensor 130. In certain embodiments, functional elements 53, 83, 93, 103, and / or 113 are configured to be deployed by an associated device, such as for deploying a functional element (e.g., a sensor-based functional element) in a patient. The deployable functional elements 53, 83, 93, 103, and / or 113 may comprise microchips and / or MEMS elements. The deployable functional elements 53 may be configured such that at least a portion thereof is visible (e.g., by image data collected by the probe 100 and / or another imaging device, such as the second imaging device 92).

[0121] In certain embodiments, functional elements 53, 83, 93, 103, 113, 203 and / or 303 may comprise one or more transducers selected from the group consisting of a heating element, e.g., a heating element configured to provide sufficient heat to ablate tissue; a cooling element, e.g., a cooling element configured to provide cryogenic energy to ablate tissue; an acoustic transducer, e.g., an ultrasound transducer; a vibration transducer; and combinations of one or more of these.

[0122] In some embodiments, functional elements 53, 83, 93, 103, and / or 113 comprise a pressure relief valve configured to prevent excessive pressure buildup in an associated device. In some embodiments, functional elements 53, 83, 93, 103, and / or 113 have one or more side holes, such as one or more side holes used to deliver fluids in a flushing procedure as described herein.

[0123] In some embodiments, functional elements 53, 83, 93, 103, 113, 203 and / or 303 comprise a visualization marker, such as when functional elements 53, 83, 93, 103 and / or 113 comprise a marker selected from the group consisting of: a radiopaque marker; an ultrasound reflective marker; a magnetic marker; an iron-based material; and combinations of one or more of these.

[0124] The probe 100 is configured to collect image data, such as image data collected during rotation and / or pullback of the optical assembly 130. The optical assembly 130 can be rotated by a rotating core 120. The optical assembly 130 can be pulled back by a pullback shaft 110. The optical assembly 130 can collect image data while surrounded by a portion of the shaft of the delivery catheter 50 (e.g., as within the transparent segment 57 of the delivery catheter) and / or without a segment of the catheter surrounding the optical assembly 130 (e.g., as when the optical assembly 100 is advanced past the distal end 59 of the delivery catheter 50 through which the probe 100 is inserted).

[0125] During collection of image data, a flushing procedure can be performed, e.g., by delivering one or more fluids, infusates 305 (e.g., as pushed by an injector 300 or other fluid delivery device) to remove blood or any other opaque material located near the optical assembly 130 (e.g., removing opaque material between the optical assembly 130 and the delivery catheter and / or between the optical assembly 130 and the vessel wall) so that light delivered from the optical assembly can reach and be reflected back from all tissues or other objects to be imaged. In these flushing embodiments, the infusates 305 can comprise an optically transparent material, e.g., saline. The infusates 305 can be one or more visualizeable materials, as described below. The infusates 305 can be delivered by an injector 300, as previously described.

[0126] Alternatively or in addition to being used in a flushing procedure, the injectate 305 may comprise a substance that is observed by a second imaging device, such as, for example, a contrast agent substance configured to be observed by a second device comprising a fluoroscope or other X-ray device, an ultrasound-reflective substance configured to be observed by a second imaging device 92 comprising an ultrasound imager, and / or a magnetic substance configured to be observed by a second imaging device 92 comprising an MRI.

[0127] Infusate 305 can be delivered by one or more delivery catheters 50 (e.g., in the space between the first delivery catheter and the inserted delivery catheter, or the space between the delivery catheter 50 and the inserted probe 100). Infusate 305 delivered in a flushing procedure (or other infusate delivery procedure) can be delivered out a distal end 59 of a delivery catheter 50 (e.g., a distal end 59 located proximal to the optical assembly 130), as described below with reference to Figures 5, 6A-E, 7A-E, 8A-D, 9A-C, or 10A-E. Alternatively or additionally, any delivery catheter 50 can comprise one or more side holes passing through a portion of the associated shaft 51, such as side hole 58 shown located in the distal portion of the delivery catheter 50. In some embodiments, the delivery catheter 50 comprises a microcatheter with a side hole 58 in its distal portion, such as a microcatheter having an inner diameter smaller than 0.027 inches (e.g., a microcatheter having an inner diameter between 0.016 inches and 0.027 inches, or between 0.021 inches and 0.027 inches). In some embodiments, flushing fluid is supplied from both side holes 58 and from the distal end 59 of the delivery catheter 50 toward the optical assembly 130, as described below with reference to FIG. 12. The side hole 58 can be configured and positioned to allow flushing fluid to pass from within the shaft 51 through the side hole 58, such as when another shaft (e.g., the shaft 110 of the probe 100 or the shaft 51 of an additional delivery catheter 50) is inserted into the delivery catheter 50. The supply of flushing fluid through the side holes 58 and / or the distal end of the delivery catheter 50 can be implemented to remove blood from certain areas of the lumen segment surrounding the optical assembly 130, for example, during acquisition of image data.

[0128] In certain embodiments, the delivery of injectate 305 during the flushing procedure is based on parameters selected from the group consisting of: a predetermined volume of injectate to deliver; a predetermined time for delivering the injectate; a delivery time including a time from a point prior to retraction of shaft 110, continuing until completion of image data acquisition (e.g., completion of shaft retraction); and one or more combinations thereof. In certain embodiments, injector 300 delivers flushing fluid with an approximate flow profile selected from the group consisting of: a 5 ml / sec delivery of contrast (e.g., 20%-100% saline miscible contrast) for 6 seconds (for imaging the carotid artery, involving 4 seconds of image data acquisition); a 4 ml / sec delivery of contrast (e.g., 20%-100% saline miscible contrast) for 6 seconds (for imaging the vertebral artery, involving 4 seconds of image data acquisition); and one or more combinations thereof. In one embodiment, the flushing procedure involves delivering infusate 305 (e.g., via one or more delivery catheters) for 2 to 8 seconds, such as approximately 4 seconds (e.g., to remove blood or other opaque fluid from a lumen segment of a blood vessel or other region surrounding the optical probe while collecting image data from the patient site PS). In a similar flushing procedure, infusate 305 is delivered (e.g., via one or more delivery catheters) at a rate of 3 ml / sec to 6 ml / sec to purge opaque material.

[0129] In these flushing procedures, the infusate 305 may be a clear fluid selected from the group consisting of saline; contrast; Dextran; and one or more combinations thereof. In some embodiments, the volume of infusate 305 delivered and / or the duration of infusate 305 delivery during a flushing procedure is determined by parameters selected from the group consisting of the type of procedure being performed; the diameter of the lumen in which the optical assembly 130 is located; the length of pullback; the time of pullback; and one or more combinations thereof. In some embodiments, the infusate 305 is delivered during a flushing procedure through a delivery catheter having an inner diameter greater than 0.027 inches (e.g., a first delivery catheter positioned proximal to a second delivery catheter 50 into which the distal end 59 of the first delivery catheter 50 is inserted). In some embodiments, the infusate 305 is delivered through multiple lumens 52 of associated multiple delivery catheters 50 (e.g., through the space between two or more pairs of two or more coaxially arranged delivery catheters 50).

[0130] In some embodiments, injectate 305 comprises a first fluid (e.g., saline and / or a fluid with minimal or no contrast) delivered during a first portion of the flushing procedure, e.g., to limit the amount of contrast delivered to the patient during the flushing procedure, and a second fluid that includes contrast (e.g., a second fluid comprising saline and contrast). In these embodiments, injector 300 may have two reservoirs (as described above), e.g., a first reservoir delivering the first fluid and a second reservoir delivering the second fluid. When having two reservoirs, injector 300 may be configured to deliver fluids from each reservoir at different flow rates, e.g., to provide flushing through different catheters having different inner diameters and / or to achieve different pressures.

[0131] As described herein, the optical assembly 130 can be rotated (e.g., by rotation of the core 120) and pulled back (e.g., through pullback of the shaft 110 by the pullback assembly 220), such as rotation combined with pullback, to form a 3D image of the patient portion PS during acquisition of image data. In some embodiments, the optical assembly 130 is rotated at a speed of 40 rps to 1000 rps (e.g., about 250 rps). In some embodiments, the optical assembly 130 is rotated at a first speed during imaging mode and at a second speed during preview mode (imaging mode and preview mode are described above). In some embodiments, the pullback of the optical assembly 130 is over a distance of 1 cm to 15 cm, e.g., about 4 cm. In some embodiments, the optical assembly 130 is pulled back at a speed of 1 mm / s to 60 mm / s. In some embodiments, the pullback of the optical assembly 130 is about 7.5 cm over 4 seconds and / or about 20 mm / s. In some cases, the pullback of the optical assembly 130 provides an axial resolution of 5 μm to 20 μm and / or a longitudinal resolution of 20 μm to 100 μm. The longitudinal resolution is governed by two factors: the spacing between subsequent rotations of the optical assembly during pullback and the spot size (cross-section of the light beam) at the tissue surface being imaged. A rotation speed of 100 rps and a pullback speed of 22 mm / s results in a pitch of 220 μm between rotations. In these cases, image data will be collected that undersamples the object being imaged by a spot size of 20 μm to 40 μm. The system 10 can be configured to more closely match the pitch and spot size, for example, by correlating the spot size with the rotation speed and / or pullback speed.

[0132] In one embodiment, as described below with reference to Figures 14 and / or 15, the imaging probe 100 and a second device (e.g., a diagnostic and / or treatment device), such as an implant delivery device 80 or a treatment device 91, are positioned in a side-by-side arrangement within a single delivery catheter 50.

[0133] Referring to FIG. 2, a flowchart of a method for generating images in accordance with the concepts of the present invention is shown. The method of FIG. 2 is illustrated using the elements and devices of system 10 described above with reference to FIG. 1. In step 2010, an imaging probe 100 is selected for use. In one embodiment, the imaging probe is configured and arranged similarly to similar elements described in Applicant's co-pending U.S. Provisional Patent Application No. 62 / 148,355, entitled "Micro-Optic Probes for Neurology," filed April 29, 2015, the entire contents of which are incorporated herein by reference. In step 2020, at least one delivery device is selected, such as the selection of one or more guidewires 60 and / or delivery catheters 50 described herein.

[0134] In step 2030, the delivery catheter 50 is advanced to a location near the patient site PS, such as a nervous system or cardiac site. Step 2030 may include advancing multiple guidewires and / or delivery catheters 50, each advanced and / or retracted sequentially, e.g., a distal-most guidewire 60 and / or delivery catheter 50 providing access to the patient site PS to be ultimately imaged (e.g., an intracranial location proximal to the patient's brain) from a remote or alternate location, such as from the patient's leg (e.g., via the femoral artery), arm (e.g., via the brachial or radial artery), or neck (e.g., via the carotid artery). In some embodiments, an anticoagulation procedure (e.g., systemic delivery of an anticoagulant such as heparin) is performed prior to inserting one or more delivery catheters 50. In some embodiments, one or more guidewires 60, one or more delivery catheters 50, and / or probe 100 are advanced through one or more veins of the patient. In some embodiments, one or more guidewires 60, one or more delivery catheters 50, and / or probes 100 are advanced in the patient's spine (e.g., the epidural space or the intrathecal space of the spine). In some embodiments, one or more delivery devices (e.g., one or more guidewires 60 and / or one or more delivery catheters 50) are advanced to a location within the patient site PS, as described below with reference to Figures 5, 6A-E, 7A-E, 8A-D, 9A-C, 10A-E, or 12.

[0135] In step 2040, the probe 100 is advanced over the guidewire 60 and / or in the delivery catheter 50 to the patient site PS (e.g., through the smallest diameter delivery catheter 50 of a series of delivery catheters 50 to access beyond the patient site PS as described herein).

[0136] In step 2050, the shaft 110 of the probe 100 is retracted, and image data (e.g., image data used to form a three-dimensional image of tissue adjacent the patient site PS) is collected during retraction. In some embodiments, the optical assembly 130 is positioned distal to the distal end of the delivery catheter 50 (in step 2040) and image data is collected, with the optical assembly 130 positioned distal to the distal end of the delivery catheter 50 (e.g., as described below with reference to FIG. 3). In other embodiments, the optical assembly 130 is positioned proximal to the distal end of the delivery catheter 50 (in step 2040) and image data is collected by the optical assembly 130 through the shaft 51 of the delivery catheter 50 (e.g., as described below with reference to FIG. 4A or 4B). In some embodiments, after the probe 100 is removed from the delivery catheter 50 (e.g., after image data is collected by the system 10 during retraction of the optical assembly 130 of the imaging probe 100), a guidewire 60 is inserted (e.g., reinserted) into the delivery catheter 50. In these embodiments, probe 100 may subsequently be reinserted into delivery catheter 50 (eg, after removing guidewire 60 and / or to collect additional image data).

[0137] In one embodiment, the first delivery catheter 50 INTRO The second delivery catheter 50 may comprise a vascular introducer (e.g., a 7Fr to 9Fr introducer) that can be placed through the patient's skin into a blood vessel (e.g., an artery or vein in the leg, arm, or neck as described herein) or at another body location using standard percutaneous techniques. GUIDE (e.g., a guide catheter or catheter with an outer diameter of 5 Fr to 7 Fr) is inserted into the delivery catheter 50 INTRO and advanced to a first anatomical location, for example, the aortic arch. GUIDE Guidewire 60 L The delivery catheter 50 can be advanced to the first body location over a hydrophilic guidewire having an outer diameter of, for example, 0.035 inches to 0.038 inches.GUIDE The delivery catheter 50 may comprise a guidewire with a straight tip or a curved tip. GUIDE delivery catheter 50, such as when it is a guide catheter with a straight tip. GUIDE Before advancing the delivery catheter 50 DIAG Delivery catheter 50 INTRO For example, the guide wire 60 L In these embodiments, the guidewire 60 is inserted into one or more blood vessels to guide the L After the catheter is advanced into the desired blood vessel, the delivery catheter 50 DIAG Remove the delivery catheter 50 GUIDE may be substituted with

[0138] Delivery catheter 50 GUIDE After the predetermined state is achieved, the probe 100 is inserted into the guide catheter 50. GUIDE and advanced to the patient site PS to be imaged (e.g., guidewire 60 L Advance by guidewire 60 L After removing the guidewire 60, a smaller or different guidewire 60 may be advanced, or the guidewire 60 may be removed. L (After removing the guidewire, the probe 100 is advanced without a guidewire). Image data can then be collected by rotating and / or pulling back the optical assembly 130 as described herein. In this case, instead of inserting the probe 100, a smaller delivery catheter 50 is inserted through the delivery catheter 50. GUIDE (e.g., intermediate catheter and / or delivery catheter 50, such as a catheter having an inner diameter of 0.053 inches to 0.070 inches. INTER ) into and through the delivery catheter 50 INTER delivery catheter 50 GUIDE In some embodiments, the guidewire 60 may be advanced to a point more distal than the distal end 59 of the guidewire. L4. Replace the guidewire with another guidewire, e.g., a smaller guidewire (e.g., having an outer diameter of 0.010 inches to 0.014 inches) 60 S Replace with

[0139] Delivery catheter 50 INTER After the predetermined state is achieved, the probe 100 is inserted into the delivery catheter 50. INTER and advanced to the patient site PS to be imaged (e.g., guidewire 60 L Advance by guidewire 60 L After removing the guidewire 60, a smaller or different guidewire 60 may be advanced, or the guidewire 60 may be removed. L (After removing the guidewire, the probe 100 is advanced without a guidewire). Image data can then be collected by rotating and / or pulling back the optical assembly 130 as described herein. In this case, instead of inserting the probe 100, a smaller delivery catheter 50 is inserted through the delivery catheter 50. INTER (e.g., a delivery catheter 50 comprising a microcatheter and / or a catheter having an inner diameter of 0.0165 inches to 0.027 inches) MICRO ) into and through the delivery catheter 50 MICRO is a delivery catheter 50 INTER In some embodiments, the guidewire 60 may be advanced to a point more distal than the distal end 59 of the guidewire. L Delivery catheter 50 INTER and insert a smaller guidewire 60 S and then the delivery catheter 50 MICRO Advance. Guidewire 60 S may comprise a guidewire having an outer diameter of 0.010 inches to 0.014 inches.

[0140] Delivery catheter 50 MICRO After the predetermined state is achieved, the probe 100 is inserted into the delivery catheter 50. MICRO and advanced to the patient site PS to be imaged (e.g., guidewire 60 Lor 60 S Advance by guidewire 60 L or 60 S After removing the guidewire 60, a smaller or different guidewire 60 may be advanced, or the guidewire 60 may be removed. L or 60 S (After removing the guidewire, the probe 100 is advanced without a guidewire). Image data can then be collected by rotating and / or pulling back the optical assembly 130 as described herein. In this case, instead of inserting the probe 100, the delivery catheter 50 (as described below with reference to FIG. 10) can be inserted. INTER The delivery catheter 50 MICRO (For example, if the guidewire 60 is a delivery catheter 50 MICRO ) and advance the delivery catheter 50 MICRO Any inserted guide wire 60 is removed, and the probe 100 is inserted into the delivery catheter. INTER The optical assembly 130 may be subsequently rotated and / or retracted to collect image data, as described herein.

[0141] Referring to FIG. 3, a partial cross-sectional side view of a system including an imaging probe and a delivery catheter is shown, where the imaging probe includes an optical assembly configured to collect image data while positioned outside the delivery catheter. The system 10 includes a probe 100 and at least one delivery catheter 50 (each of which may be configured and arranged similarly to the elements described above with reference to FIG. 1). The probe 100 includes a proximal connector 102 and a spring tip 104, as described herein. The imaging probe 100 and delivery catheter 50 are configured and arranged such that the optical assembly 130 can be positioned distally relative to the distal end of the shaft 51 of the delivery catheter 50. For example, the probe 100 may have a length (e.g., a longer length shaft 110) that is longer than the length of the delivery catheter 50; for example, the probe 100 may have a length at least 1 cm longer than the length of the delivery catheter 50 (e.g., at least 2 cm, 3 cm, 4 cm, or 5 cm longer). In some embodiments, the shaft 110 of the probe 100 has an insertable length of up to 200 cm and a non-insertable length (i.e., the proximal portion of the shaft 110) of about 7 cm. In some embodiments, at least the distal portion 118 of the shaft 110 has an outer diameter of about 0.014 inches (e.g., when the delivery catheter 50 has an inner diameter of about 0.0165 inches (e.g., an outer diameter of about 0.022 inches)). In some embodiments, at least the distal portion 118 of the shaft 110 has an outer diameter of about 0.014 inches to 0.016 inches (e.g., when the delivery catheter 50 has an outer diameter of 0.032 inches or less). In some embodiments, the probe 100 has a length of up to 200 cm (e.g., when the delivery catheter 50 has a length at least 2 cm shorter than the length of the probe 100). The probe 100 may be retracted during acquisition of image data, such as by retracting the shaft 110 of the probe 100 by at least 1 cm, such as by at least 2 cm, 3 cm, 4 cm, 5 cm, 8 cm, or 10 cm.The system 10 may comprise one or more delivery catheters 50, with the delivery catheter 50 shown being the smallest diameter of the set of delivery catheters 50 positioned in the patient and having a probe 100 inserted therein.

[0142] 4A and 4B, partial cross-sectional side views are shown of two configurations of a system comprising an imaging probe and a delivery catheter, the imaging probe comprising an optical assembly configured to collect image data while positioned within a distal portion of the delivery catheter in accordance with the concepts of the present invention. System 10 comprises a probe 100 and a delivery catheter 50 (each of which may be similar in configuration and arrangement to the elements described above with reference to FIG. 1). Imaging probe 100 and delivery catheter 50 are configured and arranged such that an optical assembly 130 can be positioned within a distal portion of shaft 51 of delivery catheter 50. For example, delivery catheter 50 may have a closed end (as shown in FIG. 4B) and / or optical assembly 130 can be positioned within a distal portion of delivery catheter 50 during pullback for image data collection. In some embodiments, the delivery catheter 50 is first inserted into the patient over the guidewire 60 (and, e.g., through one or more additional, larger diameter delivery catheters 50, not shown, but as described herein), and then the imaging probe 100 is inserted into the delivery catheter to the position shown in FIG. 4A or 4B. In other embodiments, the delivery catheter 50 and the imaging probe 100 are inserted into the patient simultaneously (e.g., together through a second, larger diameter delivery catheter 50 with the guidewire 60 removed). In these embodiments, Imaging probe 100and delivery catheter 50 can be frictionally engaged with one another, e.g., to maintain a relative positional relationship between the shafts of these two devices. Imaging probe 100 can be configured and arranged to be released and slidably removed from delivery catheter 50. System 10 can comprise one or more delivery catheters 50, with the illustrated delivery catheter 50 being the smallest diameter of the set of delivery catheters 50 deployed within the patient, with probe 100 inserted therein.

[0143] In some embodiments, delivery catheter 50 comprises a lumen with a closed end (also known as a blind lumen), such as lumen 52 shown in FIG. 4B. In some embodiments, delivery catheter 50 is configured and arranged to be advanced over a guidewire (e.g., guidewire 60 described herein) in a rapid exchange manner using rapid exchange lumen sidecar 56 shown in FIG. 4B. Delivery catheter 50 may comprise a transparent portion 57, as described above, although not shown.

[0144] Referring to FIG. 5, an anatomical diagram of an imaging system comprising multiple devices percutaneously inserted into a patient in accordance with the concepts of the present invention is shown. System 10 comprises a kit of delivery devices including probe 100, multiple delivery catheters 50, and one or more guidewires 60. In one embodiment, system 10 comprises one or more elements similar to system 10, as described above with reference to FIG. 1. Delivery catheter 50 may comprise one or more delivery catheters, such as introducer 50a, first delivery catheter 50b (e.g., a guide catheter as described herein), second delivery catheter 50c (e.g., an intermediate catheter as described herein), and / or third delivery catheter 50d, each as shown in FIG. 50d (for example Book Explained in the specification MicroThe delivery catheter 50a is inserted into a patient's blood vessel, such as the patient's femoral artery, brachial artery, radial artery, carotid artery, or vein, for example, through the patient's skin using standard percutaneous techniques to place the elongate device in the patient's blood vessel. A guidewire 60 (e.g., A guidewire (e.g., having an outer diameter of 0.035 to 0.038 inches) is placed through delivery catheter 50a. Delivery catheter 50b is inserted (e.g., over guidewire 60) through delivery catheter 50a, e.g., so that its distal end is positioned just distal or proximal to the aortic arch, e.g., near the intracranial artery (ICA) or vertebral artery. Delivery catheter 50c is then inserted (e.g., over guidewire 60) through delivery catheter 50b, and its distal end is advanced to a more distal location within the vessel, such as the middle cerebral artery (MCA). In some embodiments, the distal end of the delivery catheter 50c is positioned within or at least near a location selected from the group consisting of the internal carotid artery, the intracranial internal carotid artery (from the cervical ICA), the petrous ICA, the proximal cavernous ICA, the distal cavernous / clinoid ICA, the supra-clinoid ICA, the M1 segment V3-4 junction of the vertebral artery, the distal V4, the proximal basilar, the proximal-midbasilar, the midbasilar, and one or more combinations thereof. In some embodiments, the guidewire 60 is replaced with a smaller guidewire 60 (e.g., a guidewire having an outer diameter of 0.010 inches to 0.014 inches as described herein). Subsequently, delivery catheter 50d is inserted through second delivery catheter 50c (e.g., over guidewire 60) so that its distal end is positioned near (e.g., immediately distal to, within, and / or immediately proximal to) the patient site, which may be the neural or cardiac site described above.

[0145] As described herein, the guidewire 60 may comprise multiple guidewires, e.g., multiple guidewires having different lengths, diameters, and / or stiffnesses, such as when advancing a subsequent delivery catheter 50 over a guidewire 60 that is more flexible than the previous delivery catheter 50 (e.g., when advancing a smaller delivery catheter to a more distal location using a more flexible guidewire 60). In some embodiments, one or more of the delivery catheters 50a-d each comprise a Touhy valve in a connector 55a-d at its proximal end, e.g., to reduce blood leakage from the proximal end of the associated delivery catheter 50. In some embodiments, one or more of the delivery catheters 50 comprise a port 54 (e.g., port 54b shown at the proximal end of delivery catheter 50b) for connection to a source of contrast, flushing, and / or other fluids to be delivered, e.g., via the lumen 52 (not shown) of the associated delivery catheter 50.

[0146] The distal end 119 of the shaft 110 is advanced adjacent to the distal end of the delivery catheter 50d. In some embodiments, image data is collected while the shaft 110 is retracted, with the optical assembly 130 residing within the shaft of the delivery catheter 50d (as described below with reference to FIGS. 8A-8E). In these embodiments, the distal portion of the delivery catheter 50d may comprise a transparent segment, such as a transparent segment (not shown), as described herein, such that the optical assembly 130 resides within the transparent segment 57 while the image data is collected. In other embodiments, the delivery catheter 50d is retracted, and the optical assembly 130 resides outside the shaft of the delivery catheter 50d while image data is collected (e.g., during retraction of the shaft 110, as described below with reference to FIGS. 7A-E). In yet another embodiment, while collecting image data (e.g., during retraction of the shaft 110 as described below with reference to Figures 6A-D), the probe 100 is advanced so that the optical assembly 130 is positioned distal to the distal end of the delivery catheter 50d, and similarly so that the optical assembly 130 is outside the shaft of the delivery catheter 50d.

[0147] A flushing procedure (e.g., as described herein) may be performed through any delivery catheter 50 before and / or during collection of image data by optical assembly 130. In some embodiments, upon confirmation of adequate removal, for example, by analysis of image data collected by optical assembly 130 (e.g., by an operator's analysis of the images or automated analysis performed by algorithm 240), retraction of shaft 110 begins.

[0148] In one embodiment, system 10 comprises probe 100 and one or more delivery catheters, and / or devices and / or implants configured to treat a disease or disorder such as stroke or to remove a blood clot from a blood vessel. In these embodiments, the system 10 may comprise one or more elements selected from the group consisting of the probe 100 and a delivery catheter 50 comprising an approximately 8 Fr to 9 Fr balloon guide catheter; a treatment device 91 (previously described with reference to FIG. 1 ) comprising a thrombectomy device, e.g., a Penumbra 5 MaxAce (or similar); a delivery catheter 50 having a distal portion having an outer diameter of approximately 5 Fr, an inner diameter of approximately 0.054 inches, and / or a length of approximately 132 cm and / or a Covidien Solitaire FR Retriever (or similar); a delivery catheter 50 configured to deliver the treatment device 91 comprising a thrombectomy device, e.g., a catheter having an inner diameter of approximately 0.021 inches to 0.027 inches; a guidewire, such as a Stryker Synchro guidewire; and combinations of one or more of these.In certain stroke treatment or other thrombus removal applications, the system 10 comprises a probe 100 and one or more elements selected from the group consisting of a delivery catheter 50 comprising an approximately 8 Fr to 9 Fr balloon guide catheter (e.g., a delivery catheter 50 advanced into an adjacent vessel such as the subclavian artery or the adjacent internal carotid artery just proximal to the vertebral artery takeoff, which is inflated to prevent antegrade flow); a delivery catheter 50 such as an approximately 9 Fr Stryker Merci Balloon Guide Catheter; an approximately 8 Fr Stryker Flowgate balloon guide catheter; a treatment device 91 comprising a Penumbra ACE 64 or the like; a delivery catheter 50 comprising a Covidien Marksman microcatheter or the like having a diameter (e.g., outer diameter) of approximately 0.027 inches; a treatment device 91 comprising a Covidien Solitaire FR retriever device or the like; and combinations of one or more of these. In some embodiments, system 10 includes both a treatment device 91 comprising a thrombus removal device (e.g., a Penumbra ACE 64 device or a similar thrombus removal device) and a delivery catheter 50 configured to remove the thrombus. In these embodiments, treatment device 91 comprising the thrombus removal device is used first, and if treatment device 91 is unable to sufficiently remove the thrombus, delivery catheter 50 is used to remove the thrombus.In certain stroke treatment or other thrombectomy device applications involving the deployment of a thrombectomy device (e.g., a Penumbra ACE™ or other stent retriever), the system 10 comprises a probe 100 and one or more elements, including a first delivery catheter 50 comprising an introducer having an inner diameter of 7 French to 9 French; a second delivery catheter 50 configured to be slidingly received by the first delivery catheter 50 and having an inner diameter of 5 French to 7 French, an inner diameter of approximately 0.088 inches, a length of 80 cm to 90 cm, and / or a guide catheter having a distal end configured to be positioned proximal to the aortic arch; a third delivery catheter (50) configured to be slidingly received by the recovery catheter and comprising a reperfusion catheter having an outer diameter of 3.8 Fr to 5.4 Fr and / or a length of 132 cm to 153 cm; a fourth delivery catheter (50) configured to be slidingly received by the third delivery catheter (50) and comprising a microcatheter having an outer diameter of approximately 2.6 Fr and / or a length of approximately 160 cm; an injector (300) comprising an automatic injector; a treatment device comprising a stent retriever and / or other thrombus removal device; a Penumbra ACE™ stent retriever; and combinations of one or more thereof.

[0149] In certain embodiments, system 10 comprises probe 100 and one or more delivery devices and / or implants configured to treat a disease or disorder, such as an aneurysm. In these embodiments, system 10 can be configured to treat an aneurysm by coil delivery, such as when system 10 includes probe 100 and one or more elements selected from the group consisting of: a guide catheter 50 comprising an approximately 6 Fr guide catheter (e.g., a 6 Fr Cordis Envoy catheter (or the like) and / or a 6 Fr Penumbra Neuron catheter (or the like)); a delivery catheter 50 comprising a Stryker SL-10 catheter (or the like); an implant 85 comprising one or more embolic coils (e.g., one or more Target embolic coils (or the like)); an implant delivery device (e.g., a catheter configured to deliver one or more embolic coils); and one or more combinations thereof. In certain aneurysm treatment applications involving coil delivery, the system 10 comprises a probe 100 and one or more elements selected from the following group: a delivery catheter 50 comprising an approximately 6 Fr catheter (e.g., a 6 Fr Cordis Envoy™ catheter and / or a 6 Fr Penumbra Benchmark™ catheter); a delivery catheter 50 comprising a Stryker SL-10™ catheter (or the like); a delivery catheter 50 comprising a Covidien Echelon™ Catheter (e.g., Echelon 14, Echelon 10, or the like), e.g., a catheter approximately 150 cm in length and having a tip angle of 0°, 45°, or 90°; a guidewire 60 comprising a Covidien X-Celerator™ hydrophilic guidewire, a Covidien X-pedion™ guidewire, and / or a Stryker Synchro™ guidewire; one or more occlusion coils; and one or more combinations thereof.In certain aneurysm treatment applications, including coil delivery, system 10 comprises probe 100 and one or more elements selected from the following group: a first delivery catheter 50 comprising an introducer having an inner diameter of 7 French to 9 French; a second delivery catheter 50 comprising a guide catheter having an inner diameter of 5 French to 7 French, a Touhy valve, and / or a length of approximately 90 cm and configured to be slidingly received by the first delivery catheter; and a third delivery catheter comprising an intermediate catheter slidingly received by second delivery catheter 50 and configured to have an outer diameter of less than 7 French and / or a length of approximately 115 cm. a fourth delivery catheter 50 comprising a microcatheter configured to be slidingly received by the third delivery catheter 50 and to have an inner diameter of approximately 0.0165 inches and / or a length of approximately 150 cm; a first guidewire 60 slidingly received by the first delivery catheter 50, the second delivery catheter 50, the third delivery catheter 50 and / or the fourth delivery catheter 50 and to have a diameter (e.g., outer diameter) of approximately 0.014 inches and / or a length of 175 cm to 190 cm; an injector 300 comprising an automatic injector; a treatment device comprising a coil deployment catheter; and combinations of one or more of these.

[0150] Alternatively, or in addition, system 10 may be configured to treat an aneurysm by deploying a flow diverter, for example, where system 10 comprises probe 100 and one or more elements selected from the following group: a delivery catheter 50 comprising a guide catheter, such as a guide catheter having an inner diameter of about 6 French and / or a length of about 110 cm (e.g., configured for delivery beyond the aortic arch); a guidewire 60 (e.g., a guidewire having an outer diameter of about 0.035 inches); a Cook Guidewire (or similar); a delivery catheter 50 comprising a catheter having an inner diameter of about 0.058 inches, an outer diameter less than 7 French, and / or a length of about 115 cm; a delivery catheter 50 having an outer diameter of about 2.7 French, an inner diameter of about 0.027 inches, and / or a length of about 135 cm to 150 cm; a flow diverter, e.g., Covidien EV3 a Pipeline™ flow diverter (or similar); a delivery catheter 50 configured to deliver a flow diverter, such as a Covidien Excelsio™ XT-27 catheter (or similar); or a combination of one or more of these.In certain applications for aneurysm treatment including placement of a flow diverter, system 10 comprises probe 100 and one or more elements selected from the following group: a delivery catheter 50 comprising an approximately 5 Fr or 6 Fr sheath, such as a 6 Fr Cool Flexor Shuttle™ guide catheter (e.g., capable of being delivered across the aortic arch); a delivery catheter 50 having a length of approximately 115 cm and / or an inner diameter of 0.058 inches, such as a Covidien EV3™ 5 Fr catheter; a Covidien EV3™ 5 Fr catheter; a Covidien Marksman™ 0.027 inch catheter; an implant 85 comprising a Covidien EV3 Pipeline™ Flow Diverter (e.g., delivered by a Covidien Marksman™ 0.027 inch catheter); a Cook 0.035 inch guidewire, a Covidien X-Celerator™ hydrophilic guidewire, a Covidien A guidewire 60 comprising an X-pedion™ guidewire and / or a Stryker Synchro™ guidewire; and combinations of one or more of these.In certain applications for aneurysm treatments involving placement of a flow diverter (e.g., a Pipeline™ or Pipeline Flex™ flow diverter), system 10 comprises probe 100 and one or more elements selected from the following group: a first delivery catheter 50 comprising an introducer having an inner diameter of 7 French to 9 French; a second delivery catheter configured to be slidingly received by first delivery catheter 50 and comprising an introducer having an inner diameter of 5 French to 7 French, a Touhy valve, and / or a guide catheter having a length of about 90 cm; a second delivery catheter configured to be slidingly received by second delivery catheter 50 and having an inner diameter less than 7 French and / or a length of about 115 cm. a third delivery catheter 50 comprising an intermediate catheter having a length of 0.027 inches; a fourth delivery catheter 50 configured to be slidingly received by the third delivery catheter 50 and comprising a microcatheter having an inner diameter of less than 0.027 inches; a first guidewire 60 configured to be slidingly received by the first delivery catheter 50, the second delivery catheter 50, the third delivery catheter 50 and / or the fourth delivery catheter and having a length of 175 cm to 190 cm; an injector 300, e.g., an automatic injector; a flow diverter, e.g., a Pipeline™ flow diverter or a Pipeline Flex™ flow diverter; or a combination of one or more of the foregoing.In one application for aneurysm treatment involving placement of a flow diverter (e.g., a Surpass™ or Surpass Future™ flow diverter), system 10 comprises probe 100 and one or more elements selected from the following group: a first delivery catheter 50 comprising an introducer having an inner diameter of 7 French to 9 French; a second delivery catheter 50 configured to be slidingly received by first delivery catheter 50 and comprising a guide catheter having an inner diameter of 5 French to 7 French, a Touhy valve, and / or a length of approximately 90 cm; a third delivery catheter 50 configured to be slidingly received by second delivery catheter 50 and comprising an intermediate catheter having an outer diameter less than 7 French and / or a length of approximately 115 cm. 0; a fourth delivery catheter 50 configured to be slidingly received by the third delivery catheter and comprising a Surpass™ delivery catheter, a microcatheter having an outer diameter of less than 3.3 Fr or less than 3.7 Fr and / or a length of approximately 135 cm; a first guidewire 60 configured to be slidingly received by the first delivery catheter 50, the second delivery catheter 50, the third delivery catheter 50 and / or the fourth delivery catheter and comprising an exchange length guidewire; an injector, e.g., an automatic injector; a flow diverter, e.g., a Surpass flow diverter and / or a Surpass™ flow diverter and / or a Surpass Future flow diverter; and combinations of one or more of these. a second guidewire configured to be slidingly received by the third delivery catheter 50 and / or the fourth delivery catheter and having a length of 175 cm to 190 cm; an injector 300, e.g., an automatic injector; a flow diverter, e.g., a Pipeline™ flow diverter and / or a Pipeline Flex™ flow diverter; and combinations of one or more of these.

[0151] Alternatively, or in addition, system 10 may be configured to treat an aneurysm by delivering a stent-assist coil, for example, where system 10 comprises probe 100 and one or more elements selected from the following group: a delivery catheter 50 comprising an approximately 6 Fr guide catheter, such as a 6 Fr Cordis Envoy™ catheter (or similar) and / or a 6 Fr Penumbra Neuron™ catheter (or similar); a delivery catheter 50 comprising a Cordis Prowler Select Plus™ catheter; an implant 85 comprising an implant delivery device 80 and / or a Cordis Enterprise™ revascularization device; a delivery catheter 50 comprising a Stryker XT27™ catheter; an implant delivery device 80 and / or a Stryker Neuroform™ revascularization device. An implant 85 comprising an EZ Stent System; an implant 85 comprising one or more stents; an implant 85 comprising one or more embolic coils; and any combination of one or more of these.In certain aneurysm treatment applications, including delivery of stent-assist coils, the system 10 comprises a probe 100 and one or more elements selected from the following group: a delivery catheter 50 comprising an approximately 6 Fr guide catheter, such as a 6 Fr Cordis Envoy™ catheter and / or a 6 Fr Penumbra Neuron™ catheter; a delivery catheter 50 comprising a Cordis Prowler Select™ for Enterprise and / or a Covidien Marksman™ for Neuroform; a delivery device 80 comprising an implant 85 and / or a Stryker Neuroform™ stent system; an implant 85 comprising one or more stents; an implant 85 comprising one or more embolic coils; a guidewire 60 comprising a Covidien X-Celerator™ hydrophilic guidewire, a Covidien X-pedion™ guidewire and / or a Stryker Synchro guidewire; and combinations of one or more of these.

[0152] Referring to Figures 6A-E, anatomical schematic diagrams of a sequence of steps for forming an image in accordance with the concepts of the present invention, including advancing an imaging probe beyond the distal end of a delivery catheter prior to collecting image data, are shown. System 10 comprises imaging probe 100 and one or more delivery devices, e.g., at least one delivery catheter 50 and at least one guidewire 60. In one embodiment, system 10 comprises one or more elements 10 similar to system 10 described above with reference to Figure 1. In one embodiment, system 10 has been introduced into a patient as described above with reference to Figures 1, 2, or 5. For example, delivery catheter 50 of Figure 6A may comprise one or more delivery catheters 50, e.g., one or more delivery catheters 50 including at least delivery catheter 50d of Figures 1 or 5. In Figure 6A, guidewire 60 is advanced through a lumen, e.g., a blood vessel, such that its distal end is positioned at or beyond patient site PS. Delivery catheter 50 is advanced partially over guidewire 60. While patient site PS in Figures 6A-E is illustrated as including an aneurysm, patient site PS may alternatively or additionally be the site of another patient disease or disorder, a site including an implant such as implant 85, a site including a patient treatment device, e.g., treatment device 91, and / or any location within the patient's body as described herein.

[0153] In FIG. 6B, the distal end of the delivery catheter 50 is advanced near the patient site PS (e.g., just proximal as shown). In FIG. 6C, the guidewire 60 is removed, and the probe 100 is inserted through the delivery catheter 50 with its distal end, including the spring tip 104, proximal to the distal end of the delivery catheter 50. In FIG. 6D, the probe 100 is advanced so that the optical assembly 130 is positioned outside the delivery catheter 50, distal to and / or within the patient site PS. Subsequently, the shaft 110 of the probe 100 is retracted to the position shown in FIG. 6E while image data is collected. The collected image data includes image data of blood, vessel wall, and other tissues at the patient site PS, and / or image data of an occlusion (e.g., a thrombus or plaque). In certain embodiments, the image data further includes image data of an implant (e.g., an implant 85 described herein), e.g., as described with reference to FIGS. 9A-C, and / or image data of a treatment device, such as treatment device 91.

[0154] A flushing procedure (e.g., as described herein) may be performed during one or more of steps 6A-E via any delivery catheter 50. In some embodiments, a flushing procedure is performed during at least step 6D, e.g., via the illustrated delivery catheter 50 or via a closer delivery catheter 50 (not shown). In some embodiments, adequate cleaning is confirmed by analysis of image data collected by optical assembly 130 (e.g., by an operator or automated analysis performed by algorithm 240) to initiate retraction of shaft 110.

[0155] Referring to Figures 7A-E, schematic anatomical views of a sequence of steps for forming an image, including retracting a delivery catheter to expose an optical assembly including an imaging probe prior to collecting image data, are shown in accordance with the concepts of the present invention. System 10 includes imaging probe 100 and one or more delivery devices, e.g., at least one delivery catheter 50 and at least one guidewire 60. In some embodiments, system 10 comprises one or more elements similar to system 10 as described above with reference to Figure 1. In some embodiments, system 10 is inserted into a patient as described above with reference to Figure 5, e.g., where delivery catheter 50 of Figure 7A comprises one or more delivery catheters 50, e.g., one or more delivery catheters 50 including at least delivery catheter 50d of Figure 5. In Figure 7A, guidewire 60 is advanced through a lumen, e.g., a blood vessel, such that its distal end is positioned at or beyond patient site PS. Delivery catheter 50 is advanced partially over guidewire 60. Although the patient site PS in Figures 7A-E is illustrated as including an aneurysm, the patient site PS may alternatively or additionally be a site of another disease or disorder in the patient, a site including an implant such as implant 85, a site including a treatment device in the patient, e.g., treatment device 91, and / or any location within the patient's body.

[0156] In FIG. 7B, the distal end of the delivery catheter 50 is advanced distal to and / or into the patient site PS. In FIG. 7C, the guidewire 60 is removed, and the probe 100 is inserted through the delivery catheter 50 with its distal end, including the spring tip 104, proximal to the distal end of the delivery catheter 50. In FIG. 7D, the delivery catheter 50 is retracted so that the optical assembly 130 is positioned outside the delivery catheter 50, distal to and / or within the patient site PS. Image data is subsequently collected while the shaft 110 of the probe 100 is retracted to the position shown in FIG. 7E. The collected image data includes image data of blood, vessel walls, and other tissues at the patient site PS, and / or image data of an occlusion (e.g., a thrombus or plaque) at the patient site PS. In certain embodiments, the image data further includes image data of an implant (e.g., implant 85 described herein), e.g., as described below with reference to FIGS. 9A-C, and / or image data of a treatment device, such as treatment device 91.

[0157] A flushing procedure (e.g., as described herein) may be performed during one or more of steps 7A-E via any delivery catheter 50. In some embodiments, a flushing procedure is performed during at least step 7D, e.g., via the illustrated delivery catheter 50 or via a closer delivery catheter 50 (not shown). In some embodiments, adequate cleaning is confirmed by analysis of image data collected by optical assembly 130 (e.g., by an operator analyzing the images or automated analysis performed by algorithm 240) to initiate retraction of shaft 110.

[0158] Referring to Figures 8A-D, anatomical schematic diagrams of a sequence of imaging steps, including collecting image data while an imaging probe optical assembly is positioned within a delivery catheter, in accordance with the concepts of the present invention, are shown. System 10 includes imaging probe 100 and one or more delivery devices, e.g., at least one delivery catheter 50 and at least one guidewire 60. In some embodiments, system 10 comprises one or more elements similar to system 10 as described above with reference to Figure 1. In some embodiments, system 10 is inserted into a patient as described above with reference to Figure 5, e.g., where delivery catheter 50 of Figure 8A comprises one or more delivery catheters 50, e.g., one or more delivery catheters 50 including at least delivery catheter 50d of Figure 5. In Figure 8A, guidewire 60 is advanced through a lumen, e.g., a blood vessel, so that its distal end is positioned at or beyond patient site PS. Delivery catheter 50 is advanced partially over guidewire 60. While the patient site PS in Figures 8A-D is illustrated as including an aneurysm, the patient site PS may alternatively or additionally be a site of another disease or disorder in the patient, a site including an implant such as implant 85, a site including a treatment device in the patient, e.g., treatment device 91, and / or any location within the patient's body.

[0159] In FIG. 8B, the distal end of the delivery catheter 50 is advanced distal to and / or into the patient site PS. In FIG. 8C, the guidewire 60 has been removed, and the probe 100 is inserted through the delivery catheter 50 with its distal end 119 proximal to the distal end of the delivery catheter 50. In certain embodiments, the probe 100 further includes a spring tip 104, as previously described. Image data is subsequently collected while the shaft of the probe 100 is retracted to the position shown in FIG. 8D. In these embodiments, the distal portion of the shaft of the delivery catheter 50 may comprise a transparent segment, as described below with reference to FIG. 9. The collected image data includes image data of blood, vessel walls, and other tissues at the patient site PS, and / or image data of occlusions (e.g., thrombus or plaque) at the patient site PS. In some embodiments, the image data further includes image data of an implant (e.g., implant 85 described herein), such as image data described below with reference to Figures 9A-C, and / or image data of a treatment device, such as treatment device 91.

[0160] A flushing procedure (e.g., as described herein) may be performed during one or more of steps 8A-E via any delivery catheter 50. In some embodiments, a flushing procedure is performed during at least step 8C, e.g., via the illustrated delivery catheter 50 or via a closer delivery catheter 50 (not shown). In some embodiments, adequate cleaning is confirmed by analysis of image data collected by optical assembly 130 (e.g., by an operator analyzing the images or automated analysis performed by algorithm 240) to initiate pullback of shaft 110.

[0161] Referring to Figures 9A-C, an anatomical schematic diagram of an imaging sequence including advancing a delivery catheter over an imaging probe to a patient site to be imaged in accordance with the concepts of the present invention is shown. System 10 includes imaging probe 100 and one or more delivery devices, such as at least one delivery catheter 50 and at least one guidewire 60 (not shown, but as described above with reference to Figure 1), as well as implant 85. In some embodiments, system 10 comprises one or more elements similar to system 10 as described above with reference to Figure 1. In some embodiments, system 10 is inserted into a patient as described above with reference to Figure 5. The delivery catheter 50 of Figure 9A may comprise one or more delivery catheters 50, such as when the one or more delivery catheters 50 comprise at least one delivery catheter 50d of Figure 5. In some embodiments, the delivery catheter 50 comprises a transparent segment 57 and / or a functional element 53 (e.g., a radiopaque marker) in the distal portion of the shaft 51, as described below with reference to Figure 11. The transparent segment 57 may have a length of up to 15 cm, e.g., up to 10 cm, up to 5 cm, up to 2 cm, or up to 1 cm.

[0162] In FIG. 9A , probe 100 is inserted through delivery catheter 50 and beyond the distal end of delivery catheter 50 to be positioned within and / or distal to implant 85 (e.g., an implant for treating an aneurysm and / or stenosis, and / or one or more other implants as described above with reference to FIG. 1 ). In FIG. 9B , delivery catheter 50 can be advanced so that transparent segment 57 is positioned around optical assembly 130 (e.g., optical assembly 130 is positioned proximal to the distal end of transparent segment 57). Image data is subsequently collected while shaft 110 of probe 100 is retracted to the position shown in FIG. 9C . The collected image data includes image data of blood, vessel wall, and other tissue at patient site PS, occlusion (e.g., thrombus or plaque) and / or implant 85 at patient site PS (e.g., aneurysm, stenosis, implant site, treatment device site, and / or other patient site described herein). In one embodiment, probe 100 is withdrawn without advancing delivery catheter 50, as shown in Figure 9B.

[0163] A flushing procedure (e.g., as described herein) may be performed during one or more of steps 9A-E via any delivery catheter 50. In some embodiments, a flushing procedure is performed during at least step 9C, e.g., via the illustrated delivery catheter 50 or a more nearby delivery catheter 50 (not shown). In some embodiments, adequate cleaning is confirmed by analysis of image data collected by optical assembly 130 (e.g., operator analysis of the images or automated analysis performed by algorithm 240) to initiate pullback of shaft 110.

[0164] 10A-E, a delivery catheter 50 is advanced over a smaller delivery catheter 50, which is then removed from the lumen of the larger delivery catheter 50, and a probe 100 is inserted as desired. The system 10 includes an imaging probe 100, one or more delivery devices, such as at least one delivery catheter 50 and at least one guidewire 60. As shown in FIG. 10A, the delivery catheter 50 MICRO may require a larger delivery catheter 50 (e.g., over a guidewire 60 having an outer diameter of 0.010 inches to 0.014 inches). INTER The delivery catheter 50 is inserted into the MICRO has its distal end 59 MICRO Delivery catheter 50 INTER through its distal end 59 INTER (e.g., distal end 59 MICRO 10A-E is illustrated as including an aneurysm, the patient site PS may alternatively or additionally be the site of another patient disease or disorder, a site including an implant such as implant 85, a site including a patient treatment device, e.g., treatment device 91, and / or any internal location of the patient as described herein.

[0165] Delivery catheter 50 INTER For example, a delivery catheter 50 having an introducer (e.g., a vascular introducer) INTRO a larger delivery catheter 50 inserted through the GUIDE through the delivery catheter 50 INTER 10A) through one or more delivery catheters 50, such as when a delivery catheter INTER Subsequently, a smaller delivery catheter, delivery catheter 50, is inserted as shown in FIG. 10B. S (e.g., delivery catheter 50S (as in placing the catheter over the guidewire 60). L Subsequent advancement of the delivery catheter 50 S delivery catheter 50 over guidewire 60 alone (without the benefit of the support provided by L than can be achieved by advancing the delivery catheter 50 L This may result in safer and / or more effective progression of the delivery catheter 50. INTER The distal end 59 of INTER The delivery catheter 50 may be positioned proximal to the patient site PS (as shown), within the patient site PS, and / or distal to the patient PS. MICRO Delivery catheter 50 INTER After advancing the smaller delivery catheter 50 S 10C, and if appropriate, the enclosed guidewire 60 can be removed. Subsequently, as shown in FIG. 10D, the probe 100 is inserted into the delivery catheter. INTER , for example, to a location within and / or just distal to the patient site PS (e.g., the optical assembly 130 is located within and / or just distal to the patient site PS). MICRO By performing this removal, a larger diameter probe 100 can be accommodated and / or the probe 100 and surrounding delivery catheter 50 can be made smaller (e.g., to reduce the resistance encountered during the flushing procedures described herein). INTER In one embodiment, the probe 100 has an outer diameter of 0.014 inches to 0.025 inches, allowing for greater clearance between the surrounding delivery catheter 50. LThe probe 100 has an inner diameter of 0.053 inches to 0.070 inches. The shaft 110 of the probe 100 can be pulled back (e.g., after initiating a flushing procedure) and moved to the proximal end of the patient site PS while collecting image data, as shown in FIG. 10E. Flushing fluid (e.g., injectate 305 via injector 300) is delivered through the probe 100 and delivery catheter 50. INTER Alternatively or additionally, the space between any two delivery catheters (e.g., delivery catheter 50) can be filled with the fluid. GUIDE and delivery catheter 50 INTER and / or the delivery catheter 50 INTRO and 50 GUIDE and the space between them) can be supplied with flushing fluid via one or more ports 54, as described herein above.

[0166] Referring to FIG. 11, a system according to the concepts of the present invention is shown schematically, including an imaging probe and a delivery catheter having a shaft with a transparent segment. System 10 includes imaging probe 100, which may be configured and arranged similarly to imaging probe 100 described with reference to FIG. 1. System 10 further includes one or more delivery devices, such as the illustrated delivery catheter 50. Probe 100 and delivery catheter 50 are configured and arranged, as described herein, so that delivery catheter 50 can slidingly receive probe 100. System 10 may further include other delivery devices, such as one or more additional delivery catheters and / or one or more guidewires (e.g., one or more guidewires configured and arranged to support over-the-wire advancement of delivery catheter 50 and / or probe 100).

[0167] Delivery catheter 50 comprises a shaft 51 having an elongate shaft, a proximal portion 51a, and a distal portion 51b. In some embodiments, distal portion 51b has a smaller diameter than proximal portion 51a. In some embodiments, proximal portion 51a has an outer diameter of about 0.024 inches and / or an inner diameter of about 0.165 inches. In some embodiments, distal end 51b has an outer diameter of about 0.022 inches and / or an inner diameter of about 0.165 inches. In some embodiments, distal portion 51b is more flexible than proximal portion 51a. Distal portion 51b comprises an optically clear portion, transparent segment 57. Distal portion 51b and / or transparent segment 57 may have a length of at least 1 cm, e.g., at least 2 cm, 3 cm, 4 cm, 5 cm, 7 cm, or 10 cm. Delivery catheter 50 may comprise one or more functional elements, such as functional element 53 shown disposed in distal portion 51 b. In some embodiments, functional element 53 comprises a visualization marker, such as a marker selected from the group consisting of a radiopaque marker, an ultrasound reflective marker, a magnetic marker, an ferrous marker, and combinations of one or more of the foregoing.

[0168] In one embodiment, the delivery catheter 50 comprises a connector 55, such as a Touhy or other connector, having a port (e.g., the port 54 described above) at its proximal end, which can be attached to a fluid source (e.g., a syringe, power injector, etc.) as described herein.

[0169] Referring to FIG. 12, an anatomical schematic diagram of a system including a delivery catheter and an imaging probe, including a side hole for supplying flushing fluid, according to the concepts of the present invention is shown. The system 10 includes a probe 100 and at least one delivery catheter 50, which may be configured and arranged similarly to the elements described with reference to FIG. 1. The distal ends of the delivery catheter 50 and probe 100 are shown in enlarged view (to the right of the drawing). The delivery catheter 50 and probe 100 are inserted into a patient (as in an interventional procedure involving one or more delivery catheters 50, as previously described with reference to FIGS. 2, 5, 6A-E, 7A-E, 8A-D, 9A-C, or 10A-E). The shaft 110 of the probe 100 is positioned within or just distal to a patient site PS, which may be an aneurysm, a stenosis, an implant site, a treatment device site, and / or other patient site PS as described herein. In one embodiment, the optical assembly 130 is positioned distal to the distal end 59 of the delivery catheter 50 as shown in FIG. 12 (e.g., to perform pullback for image data collection with the optical assembly 130 outside the shaft 51).

[0170] System 10 further comprises an injector 300, which may be configured to supply one or more fluids to one or more delivery catheters 50 or other elements of system 10. Port 54 of delivery catheter 50 is attached to injector 300 so as to allow fluid to flow through tubing 301 to supply fluid to the space in lumen 52 surrounding shaft 110 of probe 100 (e.g., the space between the outer wall of shaft 110 and the inner wall of shaft 51).

[0171] Immediately prior to collecting image data, delivery of injectant 305 may be initiated by injector 300 forcing fluid into lumen 52 of shaft 51 (e.g., via tube 301) (e.g., to initiate a flushing procedure to remove undesirable material from locations around optical assembly 130 (e.g., blood or other material that may inhibit or at least limit collection of image data by optical assembly 130). Injectant 305 is delivered to these locations via distal end 59 of shaft 51 (the distal end of lumen 52) and / or side holes 58. Delivery of injectant 305 by injector 300 continues during image data collection (e.g., during rotation and retraction of optical assembly 130). In some embodiments, the flushing procedure includes delivering injectant 305 through both the distal end of shaft 51 and side holes 58.

[0172] In some embodiments, the delivery catheter 50 comprises multiple delivery catheters 50, one or more of which may have side holes 58, and may be used to deliver infusate 305 in a flushing procedure or other fluid delivery procedure. The infusate 305 comprises a contrast agent (e.g., a ratio of radiopaque contrast agent and saline), e.g., to deliver the infusate 305 to the patient site and The neighboring area You can take pictures.

[0173] Referring to FIG. 13, a schematic diagram of a system comprising an imaging probe, a rotation assembly, and a retraction assembly in accordance with the concepts of the present invention is shown. The system 10 comprises a probe 100 and a kit of delivery devices including a plurality of delivery catheters 50 and one or more guidewires. In certain embodiments, the system 10 comprises the same or similar elements as the system 10 described above with reference to FIG. 1, such as those shown in FIG. 13. The imaging probe 100 is operably connected to a retraction assembly 220. The retraction assembly 220 may comprise a linear drive assembly configured and arranged to effect movement (e.g., retraction and / or advancement) of the shaft 110 of the probe 100. In certain embodiments, a clamp 221 is removably attached to the shaft 110, and the retraction assembly 220 presses against the clamp 221 to retract the probe 100. The clamp 221 can also be manipulated by an operator, for example, to advance, retract, and / or twist the shaft 110 of the probe 100 (e.g., to assist the user in advancing the probe 100 to a patient site). The clamp 221 can be loosened and / or tightened around the shaft, allowing the clamp 221 to be repositioned along the length of the shaft 220.

[0174] In one embodiment, clamp 221 and retraction assembly 220 are configured and arranged such that during retraction of shaft 110, retraction assembly 220 pushes clamp 221, causing shaft 110 to retract. After retraction is complete, retraction assembly 220 can return to its original starting position without advancing shaft 110 (because clamp 221 is not secured to retraction mechanism 220).

[0175] The imaging probe 100 is also operably connected to a rotation assembly 210. The rotation assembly 210 comprises a motor and / or other rotation mechanism used to rotate the core 120 (and, for example, the optical assembly 130). The rotation assembly 210 and the pullback assembly 220 may be similar in structure and arrangement to assemblies used in commercially available catheter-based OCT systems. One or more elements of the system 10 may be disposable and / or reusable. Reusable elements of the system 10 are configured to be resterilizable.

[0176] Referring to FIG. 14, an anatomical schematic diagram illustrates an imaging probe in a side-by-side configuration with a second device in accordance with the concepts of the present invention. System 10 includes probe 100, one or more delivery devices, such as at least one delivery catheter 50 and at least one guidewire (not shown, but as described above with reference to FIG. 1), and a device for treating and / or diagnosing a patient, such as implant delivery device 80 or treatment device 91, as described above. Device 80 / 91 can be configured to deliver an implant 85 (e.g., a coil, stent, and / or uncovered stent, as shown). In certain embodiments, imaging probe 100, device 80 / 91, and / or other elements of system 10 are configured and arranged similarly to the elements of system 10 described above with reference to FIG. 1 (e.g., when imaging probe 100 includes shaft 110, optical assembly 130, and / or spring tip 104, as shown). In some embodiments, system 10 is introduced into a patient as described above with reference to FIG. 5, such as when delivery catheter 50 of FIG. 14 includes one or more delivery catheters 50 (e.g., one or more delivery catheters 50 including at least delivery catheter 50d of FIG. 5). Delivery catheter 50 comprises a shaft 51 and a lumen 52. In some cases, system 10 is inserted into a patient as described below with reference to FIG. 15, such as when imaging device 100 and device 80 / 91 are configured side-by-side within lumen 52 as shown in FIG. 14. The distal ends of optical assembly 130 and device 80 / 91, respectively, are positioned proximate to a patient site PS so that imaging probe 100 can collect image data before, during, and / or after diagnosis and / or treatment with device 80 / 91, and so that diagnostic procedures (e.g., biopsy) and / or treatment procedures (e.g., placement of a coil or other implant) can be performed using device 80 / 91.

[0177] 15, a flowchart of a method for generating images using an imaging probe in a side-by-side configuration with a second device in accordance with the concepts of the present invention is shown. The method 1500 of FIG. 15 is described using the system 10 and its components as previously described. In step 1505, the delivery catheter 50 MICRO A microcatheter having an inner diameter of, for example, 0.0165 inches to 0.027 inches is advanced over guidewire 60 to a location near the patient site PS (e.g., a neurological or cardiac site as described above). In some embodiments, guidewire 60 is advanced to the location of the patient site PS (e.g., a neurological or cardiac site). In some embodiments, guidewire 60 is delivered distal to the patient site PS, for example, just distal to the stenosis of an aneurysm or just distal to a thrombus or other obstruction. Delivery catheter 50 MICRO and the guide wire 60 is the same as the catheter 50 described above. INTRO The catheter may be inserted through one or more larger delivery catheters, such as through an introducer catheter.

[0178] In step 1510, the delivery catheter 50 MICRO , leaving the guidewire 60 in place (such as when the guidewire 60 is an exchange length guidewire).

[0179] In step 1515, a larger diameter catheter, delivery catheter 50 INTER The catheter 50 is advanced over the guidewire 60 to the patient site PS. INTER may comprise a delivery catheter having an inner diameter of 0.050 inches to 0.085 inches, an inner diameter of 0.053 inches to 0.072 inches, or an inner diameter of 0.070 inches to 0.072 inches.

[0180] In step 1520, catheter 50 INTER Remove the guidewire 60 from the delivery catheter 50 (e.g., INTER (removed from the lumen of the

[0181] In step 1525, a first device (e.g., a device having an outer diameter of less than 0.035 inches) is inserted into delivery catheter 50. INTER and, in step 1530, a second device (e.g., a device having an outer diameter smaller than 0.035 inches) is advanced through the lumen of delivery catheter 50. INTER In some embodiments, the first device comprises a diagnostic and / or treatment device (e.g., device 80 and / or 91, previously described, device 80 / 91), and the second device comprises imaging probe 100 (i.e., imaging probe 100 is advanced after device 80 / 91). Alternatively, the first device comprises imaging probe 100, and the second device comprises a diagnostic and / or treatment device (e.g., device 80 and / or 91). In some embodiments, imaging probe 100 has an outer diameter less than 0.020 inches, e.g., less than but equal to 0.0165 inches. In these embodiments, device 80 / 91 is configured such that imaging probe 100 is inserted into delivery device 50. INTER (e.g., probe 100 is positioned within the same lumen of delivery device 50) INTER (similarly moving within the lumen of the delivery device 50) INTER the outer diameter (e.g., an outer diameter less than or equal to 0.035 inches, an outer diameter less than or equal to 0.030 inches, an outer diameter less than or equal to 0.025 inches, or an outer diameter less than or equal to 0.020 inches) configured to slideably move within the

[0182] In step 1535, the optical assembly 130 of the imaging probe 100 is positioned at or near the desired location, e.g., a position within an occlusion or aneurysm. An implant (e.g., implant 85) and / or diagnostic or treatment portion of device 80 / 91 may be positioned proximate the desired location, as shown in FIG.

[0183] In step 1540, a fluoroscopy procedure is performed to confirm or achieve (e.g., by repositioning) the desired placement of the optical assembly 130. The desired placement of the diagnostic or treatment portion of the device 80 / 91 may be similarly confirmed. In certain embodiments, a small bolus (e.g., 10 ml or less) of fluid containing a contrast agent may be injected (e.g., through the delivery catheter 50) to enhance fluoroscopic visualization of, for example, the patient site PS, the device 80 / 91, and / or the imaging probe 100. INTER (via)

[0184] In step 1545, one or more imaging parameters of system 10 (e.g., as described herein) are set by the physician performing the imaging procedure. In one embodiment, console 200 of system 10 is set in a preview mode, as described herein. Console 200 is configured to be set in automatic, semi-automatic, and / or manual modes (e.g., modes in which one or more imaging parameters are adjusted automatically, semi-automatically, and / or manually). Console 200 can be configured to capture image data relatively continuously or intermittently.

[0185] System 10 may be configured to deliver flushing material while collecting image data, e.g., by delivering injectate 305 via injector 300 as described above with reference to FIG. 1 . In some embodiments, console 200 may be configured for continuous image data collection mode, delivering injectate 305 at a flow rate of 2 ml / sec to 3 ml / sec for approximately 30 seconds. In some embodiments, console 200 may be configured for intermittent image data collection mode, delivering injectate 305 with a delivery profile approximating a 2-second flush every 10 seconds, e.g., delivering injectate 305 at a rate of 3 ml / sec to 4 ml / sec. In some embodiments, console 200 may be configured to automatically detect delivery of injectate 305 and timestamp collected image data (e.g., by providing a timestamp for the timing of delivery of injectate 305). In some embodiments, console 200 may be configured to control delivery of injectate 305 via injector 300 (e.g., automatically, semi-automatically, and / or manually, as described above).

[0186] In some embodiments, console 200 is configured to collect image data in a manual mode. In these embodiments, injectate 305 may be delivered in small boluses, and the delivery of injectate 305 (e.g., by injector 300) is sensed and / or controlled by the console, for example, to timestamp the collected image data as described above.

[0187] In step 1550, a clinical procedure (e.g., a diagnostic and / or therapeutic procedure) is performed using device 80 / 91. Before, during, and / or after the performance of the clinical procedure, system 10 collects image data (e.g., by retracting optical assembly 130 as previously described). In some embodiments, device 80 / 91 is configured to deliver one or more coils (e.g., occlusion coils configured to treat an aneurysm). In some embodiments, device 80 / 91 comprises a stentriever or other thrombus removal device. In some embodiments, device 80 / 91 comprises a stent delivery device, e.g., a covered stent delivery device.

[0188] In step 1555, the image data collected by the system 10 is reviewed, for example, by a physician performing the clinical and / or imaging procedure.

[0189] In step 1560, an evaluation of the image data is performed to determine whether additional diagnosis and / or treatment is necessary, or at least desirable. This evaluation may include reviewing 2D and / or 3D images of the patient site PS before, during, and / or after the clinical procedure. Alternatively or additionally, the evaluation may include reviewing 2D and / or 3D images of any implants (e.g., one or more implants 85) placed in the patient during the procedure, such as to determine sufficient occlusion (e.g., sufficient occlusion of an aneurysm by placement of a coil or covered stent), proper placement and / or apposition of the implant with tissue, adequate flow rate through the native vessel, and one or more combinations thereof.

[0190] If no further diagnosis and / or treatment is required, step 1570 is performed and the device is removed from the patient to complete the procedure.

[0191] If additional diagnosis and / or treatment is desired, step 1565 is performed and the additional diagnosis and / or treatment is performed. For example, steps 1555, 1560, and 1565 are repeated until a desired result is achieved. Additional treatments may include placement of one or more additional implants (e.g., additional coils to be placed), additional deployment of implants (e.g., deployment of a stent to improve apposition to tissue), and other treatments as described herein.

[0192] In some embodiments, in addition to step 1550, image data is collected by system 10 at any one or more of steps 1535-1550. In some embodiments, image data is collected while optical assembly 130 is pulled back approximately 20 mm, after which assembly 130 may be automatically or manually advanced to the starting location or other location proximate the distal portion of patient site PS.

[0193] During one or more steps of method 1500 of FIG. 15 , a flushing procedure (e.g., as described herein) may be performed with any delivery catheter 50. In some embodiments, the flushing procedure may be performed at least while collecting image data (e.g., during rotation and / or retraction of assembly 130), e.g., while the delivery catheter 50 INTER or by a more proximal delivery catheter 50. In one embodiment, retraction of the optical assembly 130 (e.g., retraction of the shaft 110) is initiated when adequate cleaning is confirmed by analysis of the image data collected by the optical assembly 130 (e.g., by an operator analyzing the images or by automated analysis performed by algorithm 240 of the console 200).

[0194] While preferred embodiments of the devices and methods have been described with reference to the context in which they were developed, these are merely illustrative of the principles of the inventive concepts. Modifications and combinations of the above-described assemblies, other embodiments, configurations, and methods embodying the inventive concepts, and variations on the gist of the inventive concepts, will be apparent to those skilled in the art and are intended to be within the scope of the appended claims. Furthermore, if this application recites method or procedure steps in a particular order, it is intended that the order in which certain steps are performed may be varied or may be advantageous in certain circumstances, and that the particular steps of the method or procedure recited in the claims should not be construed as being in a particular order, unless the claims expressly state a particular order. The disclosure of this specification may include the following aspects. (Aspect 1) an imaging probe comprising an elongate shaft, a rotatable optical core, and an optical assembly; a rotation assembly constructed and arranged to rotate the optical assembly; a retraction assembly constructed and arranged to retract the optical assembly and the elongate shaft together; a first delivery catheter constructed and arranged to slidingly receive the imaging probe; An imaging system comprising: The long shaft is a proximal end, a distal portion, and a lumen extending between the proximal end and the distal portion; a rotatable optical core disposed within the lumen of the elongate shaft, the rotatable optical core having a proximal end and a distal end, the rotatable optical core configured to be optically and mechanically coupled to the interface unit; an optical assembly disposed in the distal portion of the elongate shaft and proximate the distal end of the rotatable optical core, the optical assembly configured to deliver light to the tissue and collect reflected light from the tissue; The imaging probe is an imaging system constructed and arranged to collect image data from a patient site. (Aspect 2) the first delivery catheter has a distal portion with a transparent segment; The imaging system of embodiment 1, wherein the probe and first delivery catheter are configured and arranged such that the optical assembly resides within a transparent segment of the at least one delivery catheter while collecting image data. (Aspect 3) 3. The imaging system of embodiment 2, wherein the transparent segment has a length of up to 10 cm. (Aspect 4) The imaging probe has an outer diameter of 0.014 inches to 0.016 inches; The system further comprises a guidewire configured and positioned to access the patient site; the patient site includes a nerve site; the first delivery catheter has an inner diameter of 0.021 inches to 0.027 inches; a first delivery catheter configured and positioned over the guidewire to reach the neural site; an imaging probe configured and positioned for advancement within the first delivery catheter after removing the guidewire from the first delivery catheter; the first delivery catheter is configured to advance the imaging probe within the first delivery catheter and then retract the imaging probe; The imaging system according to any one of Aspects 1 to 3, wherein the imaging probe is constructed and arranged to perform retraction of the imaging probe while collecting image data after retraction of the first delivery catheter. (Aspect 5) The system further comprises a first guidewire configured to access the neural site; the first delivery catheter comprising an inner diameter of 0.021 inches to 0.027 inches and a distal portion including a transparent segment; a first delivery catheter configured and positioned to be advanced over the guidewire to the neural site; The imaging system of any one of aspects 1 to 4, wherein the imaging system is configured to collect image data by retracting the optical assembly while the optical assembly is positioned within the transparent segment of the first delivery catheter. (Aspect 6) 6. The imaging system of embodiment 5, wherein the distal portion of the elongate shaft of the imaging probe has an outer diameter of between 0.014 inches and 0.016 inches. (Aspect 7) The imaging system of any one of aspects 1 to 6, further comprising a flushing medium configured to be delivered through the first delivery catheter when the imaging probe is retracted to collect image data. (Aspect 8) 8. The imaging system of embodiment 7, wherein the imaging system is constructed and arranged to supply a flushing medium between the first delivery catheter and the imaging probe. (Aspect 9) An imaging apparatus according to any one of aspects 1 to 8, further comprising a diagnostic and / or treatment device configured and positioned to advance through the first delivery catheter while the imaging probe is present within the first delivery catheter. (Aspect 10) 10. The imaging system of embodiment 9, wherein the first delivery catheter has an inner diameter of between 0.050 inches and 0.085 inches. (Aspect 11) 11. The imaging system of aspect 10, wherein the first delivery catheter has an inner diameter of 0.053 inches to 0.072 inches. (Aspect 12) The imaging system of embodiment 9, wherein the diagnostic and / or treatment device is configured and arranged to be advanced within the first delivery catheter prior to advancing the first delivery catheter within the patient's blood vessel. (Aspect 13) The imaging system of embodiment 9, wherein the diagnostic and / or treatment device is configured and arranged to be advanced within the first delivery catheter after the first delivery catheter is advanced within the patient's blood vessel. (Aspect 14) The imaging system of embodiment 9, wherein the diagnostic and / or treatment device has an outer diameter of 0.035 inches or less. (Aspect 15) The imaging system of embodiment 9, wherein the diagnostic and / or treatment device apparatus comprises a treatment device configured to deliver one or more coils to treat the aneurysm. (Aspect 16) 10. The imaging system of embodiment 9, wherein the diagnostic and / or treatment device comprises a treatment device configured to remove a thrombus. (Aspect 17) 10. The imaging system of embodiment 9, wherein the diagnostic and / or treatment device comprises a treatment device configured to deliver a stent. (Aspect 18) 18. The imaging system according to any one of aspects 1 to 17, wherein the imaging probe further comprises a functional element. (Aspect 19) 20. The imaging system of embodiment 18, wherein the functional element comprises at least two functional elements. (Aspect 20) 20. The imaging system of embodiment 18, wherein the functional element comprises an element selected from the group consisting of a sensor, a transducer, and combinations thereof. (Aspect 21) 20. The imaging system of embodiment 18, wherein the functional element comprises a sensor configured to generate a signal. (Aspect 22) The imaging system of embodiment 21, wherein the functional element comprises a sensor selected from the group consisting of a physiological sensor, a pressure sensor, a strain gauge, a position sensor, a GPS sensor, an accelerometer, a temperature sensor, a magnetic sensor, a chemical sensor; a biochemical sensor, a protein sensor, a flow sensor such as an ultrasonic flow sensor, a gas detection sensor such as an ultrasonic bubble detector, an acoustic sensor such as an ultrasonic sensor, and combinations thereof. (Aspect 23) 22. The imaging system of embodiment 21, wherein the sensor comprises a position sensor configured to generate a signal related to vascular path placement. (Aspect 24) 24. The imaging system of any one of aspects 1 to 23, further comprising an injector constructed and arranged to supply an injectate to the first delivery catheter. (Aspect 25) 25. The imaging system of embodiment 24, further comprising an injectate comprising one or more fluids delivered by the injector. (Aspect 26) 26. The imaging system of embodiment 25, wherein the injector comprises a first reservoir and a second reservoir, and the injectate comprises a first fluid supplied from the first reservoir and a second fluid supplied from the second reservoir. (Aspect 27) 27. The imaging system of claim 26, wherein the injector is configured to supply the first fluid and the second fluid at different flow rates. (Aspect 28) An imaging system as described in any of aspects 1 to 27, wherein the first delivery catheter has a distal portion including one or more side holes and is configured to deliver injectate in a flushing procedure by passing the injectate through the one or more side holes. (Aspect 29) The imaging system according to any one of aspects 1 to 28, further comprising at least one guide wire. (Aspect 30) 30. The imaging system of embodiment 29, wherein the at least one guidewire is constructed and arranged to slidingly mate with the imaging probe. (Aspect 31) 31. The imaging system of embodiment 30, wherein the imaging probe comprises a rapid exchange lumen in a distal portion of the elongate shaft. (Aspect 32) 32. The imaging system of any one of embodiments 1 to 31, wherein the distal portion of the elongate shaft of the imaging probe has an outer diameter of 0.025 inches or less. (Aspect 33) 33. The imaging system of embodiment 32, wherein the distal portion of the elongate shaft of the imaging probe has an outer diameter of 0.016 inches or less. (Aspect 34) 34. The imaging system according to any one of embodiments 1 to 33, wherein the distal portion of the elongated shaft of the imaging probe comprises a blade portion. (Aspect 35) 35. The imaging system of any of embodiments 1-34, wherein the imaging probe is constructed and arranged to prevent relative movement between the elongate shaft and the optical assembly. (Aspect 36) The imaging system of embodiment 35, wherein the image probe further comprises a connector rotatably attached to the rotatable optical core and fixedly attached to the elongate shaft, the connector configured and arranged to prevent relative movement between the elongate shaft and the rotatable optical core. (Aspect 37) 36. The imaging system of embodiment 35, wherein the elongated shaft comprises a transparent segment having a length of 15 mm or less.

Claims

1. An imaging system comprising a first delivery device, an imaging probe, a rotation assembly, and a retraction assembly, the first delivery device comprises a first elongate shaft having a first proximal end, a first distal end, and a first lumen extending between the first proximal end and the first distal end; the imaging probe comprising a second elongate shaft, a rotatable optical core, and an optical assembly; the second elongate shaft having a second proximal end, a distal portion, and a second lumen extending between the second proximal end and the distal portion; a rotatable optical core located within the second lumen of the second elongate shaft and having a third proximal end and a second distal end; an optical assembly located within the distal portion of the second elongate shaft and proximate the second distal end of the rotatable optical core and configured to deliver light to the tissue and collect light reflected from the tissue; a rotation assembly constructed and arranged to rotate the optical assembly; a retraction assembly constructed and arranged to retract the optical assembly and the second elongate shaft together; An imaging system, wherein the first elongate shaft of the first delivery device and the second elongate shaft of the imaging probe are constructed and arranged to move together.

2. An imaging system as described in claim 1, wherein moving the first long shaft and the second long shaft includes simultaneously inserting the first long shaft and the second long shaft into the patient.

3. Further comprising a second delivery device having a third elongated shaft; 3. The imaging system of claim 2, wherein the third elongate shaft has a fourth proximal end, a third distal end, and a third lumen extending between the fourth proximal end and the third distal end, and the first elongate shaft and the second elongate shaft are constructed and arranged to move within the third lumen.

4. An imaging system as described in claim 3, wherein the first long shaft has a first outer diameter, and the third long shaft has a first inner diameter, the first inner diameter being larger than the first outer diameter.

5. The imaging system of claim 1, wherein the first delivery device and the imaging probe are configured to engage by friction.

6. An imaging system as described in claim 5, wherein the frictional engagement is configured to maintain a relative positional relationship between the first long shaft and the second long shaft.

7. The imaging system of claim 1, wherein the first lumen of the first delivery device has a closed distal end.

8. An imaging system as described in claim 1, wherein the first elongated shaft further comprises a transparent segment.

9. An imaging system as described in claim 8, wherein the transparent segment has a length of up to 1 cm.

10. An imaging system as described in claim 1, wherein the retraction assembly retracts the optical assembly at a retraction speed of 5 mm / sec to 60 mm / sec.

11. An imaging system as described in claim 10, wherein the retraction speed is approximately 40 mm / sec.

12. An imaging system as described in claim 1, wherein the retraction assembly performs a retraction procedure including retracting the optical assembly and the second elongated shaft.

13. The imaging system of claim 12, wherein the retraction procedure comprises moving the first elongated shaft together with the second elongated shaft.

14. The imaging system of claim 12, wherein the retraction procedure comprises a retraction length of 20 mm to 100 mm.

15. An imaging system as described in claim 12, wherein the pullback procedure is performed in a time period of 1 second to 15 seconds.

16. The imaging system of claim 1, wherein the retraction assembly is configured to return to the starting position without advancing the second elongated shaft.

17. An imaging system as described in claim 1, wherein one or more elements of the system are at least one of disposable elements or reusable elements.

18. An imaging system as described in claim 17, wherein one or more elements are sterilizable reusable elements.

19. The imaging system of claim 1, further comprising a display configured and positioned to provide one or more images based on reflected light collected by the optical assembly.

Images