Imaging catheter, imaging system, and method of operating the same

Abstract

An imaging device and method of operation are disclosed. The imaging device includes one or more optically transmissive windows defined along a split layer and a catheter exit port defined along an anterior side of the catheter body. The catheter exit port allows a guidewire to advance out of the second catheter lumen, and the catheter exit port is aligned with at least one of the optically transmissive windows such that the guidewire is within the field of view of the imaging component when the guidewire extends partially through the catheter exit port.

Description

Technical Field

[0001] The present disclosure generally relates to the fields of intravascular imaging, cross-sectioning, and / or ablation, and more specifically to imaging catheters, reentry devices and / or atherectomy devices, systems, and methods of operating the same.

Background Art

[0002] Minimally invasive surgical interventions have consistently been shown to be as effective as or more effective than conventional open surgical interventions and to result in lower mortality rates. For many such minimally invasive procedures, it is of utmost importance for surgeons and other medical professionals performing such interventions to be able to accurately track the positioning of instruments inserted into a patient's vasculature. Most minimally invasive procedures involve the use of a flexible guidewire and a catheter that is directed to a target vascular site using the guidewire. However, properly steering a guidewire to a target vascular site can be difficult, time-consuming, and risky. For example, an inappropriately maneuvered guidewire can cause harmful vascular dissection, perforation, or thrombosis and can cause excessive general anesthesia exposure to the patient. Some of these risks can be mitigated by heparinization, but increased use of such anticoagulants can increase the risk of bleeding due to the procedure.

[0003] Also, most guidewire navigation is currently performed under fluoroscopic imaging. However, fluoroscopic imaging often requires surgeons or other medical professionals and patients to be exposed to radiation for long periods of time.

[0004] Therefore, improved devices, systems, and methods for intravascular imaging are needed to address the challenges faced by currently available devices. Such solutions should reduce the risk of complications for patients and minimize the risk of radiation exposure for operators and patients. Furthermore, such solutions should be compatible with, or readily adaptable for use with, other minimally invasive surgical devices such as atherosclerotic catheters and catheters for stent placement. In addition, such solutions should reduce the complexity of current devices and be cost-effective to manufacture.

[0005] Atherosclerosis is characterized by the accumulation of plaque and other fatty substances in a patient's blood vessels. Initial atheromas, relatively soft and cholesterol-rich deposits, harden into calcified atherosclerotic plaques, which restrict blood flow and can ultimately lead to hypertension, angina, stroke, and myocardial infarction. Atherosclerosis is a minimally invasive endovascular procedure to remove such plaques and other fatty accumulations from arteries.

[0006] Conventional atherosclerotic plaque resection devices often include a catheter designed for lesion resection, having an opening defined along a portion of the catheter. A low-pressure balloon is often attached to the catheter on the side opposite the opening, such that the balloon's inflation biases the opening to occlude the vessel and bring it closer to the atherosclerotic plaque, and a portion of the plaque extends into or is thereby positioned in close proximity to the opening. A cutting tool within the catheter then cuts the plaque, and the crushed or pulverized plaque is collected in a collection chamber attached to the catheter. A flushing medium or other type of fluid can also be delivered into the vessel during the atherosclerotic plaque resection procedure to clear blood from the imaging field, thereby facilitating imaging of the treatment area (e.g., using optical coherent tomography (OCT)). However, all such atherosclerotic plaque resection devices have drawbacks that have not been addressed by the manufacturers of such devices to date.

[0007] For example, balloons attached to such devices are often inflated with air and are prone to rupture, thereby increasing the risk of air embolism, balloon entrapment, or vascular perforation. Furthermore, the flushing medium or other fluids delivered into the blood vessel to facilitate imaging are often delivered through a separate fluid delivery lumen, which adds complexity to the device and hinders the movement of cutting tools. Additionally, balloon inflation is often performed through an inflation lumen separate from the fluid delivery lumen, further congesting the inside of the catheter. Moreover, balloon inflation is often poorly coordinated with the delivery of the flushing medium, and therefore the blood vessel is not occluded in time for the flushing medium to take effect.

[0008] Therefore, improved devices, systems, and methods for intravascular weight loss are needed to address the challenges faced by atherosclerotic devices. In addition, such solutions should reduce the complexity of conventional atherosclerotic devices and be cost-effective to manufacture.

[0009] Blood vessels completely blocked by atherosclerosis are characterized by chronic total occlusion (CTO), which results in a severe lack of blood perfusion and oxygen supply to cardiac tissue, potentially leading to myocardial infarction and heart failure. For example, it is estimated that approximately 15–20% of patients with coronary artery disease have CTO. Potential treatments for CTO include medication, angioplasty, and / or bypass surgery. Medication may be of little effect because the artery is completely blocked, while bypass surgery has significantly higher morbidity and mortality rates.

[0010] Angioplasty and stent placement offer minimally invasive approaches to revascularizing blocked arteries with favorable patient outcomes; however, the procedures require traversing the CTO before angioplasty and stent placement can be performed. The standard for traversing CTOs is the usefulness of multiple arrays of guidewires with varying stiffness, shape, and morphology. Guidewires are typically guided by fluoroscopy, which pushes them up against the CTO within the artery, resulting in a 2D image projection that provides no cross-sectional plane information of the internal structure of the affected artery. The use of guidewires results in a poke-and-hope approach that does not guarantee success, is often time-consuming, involves extensive radiation exposure to the operator and patient, and leads to excessive anesthesia exposure for the patient being treated.

[0011] There is a need to provide a solution for visualizing cross-sectional views of arteries while traversing them, with a clear interpretation of the arteries and disease structures, while having intervention tools that operators can manipulate to remain within the artery or to re-enter after being pushed into a false lumen within the arterial wall.

[0012] For example, a re-entry device consisting of sensory or imaging elements capable of visualizing arterial cross-sections allows for investigation of the surrounding area with high-resolution and clear views of the boundaries between the arterial wall and the surrounding tissue, affected structures, recognition of misentry into the subluminal space, and identification of the true lumen. The re-entry device can then reliably orient and direct the intervention tool toward the true lumen for re-entry and traversal of the CTO. Such a systematic approach would significantly improve usability, reduce procedure time, decrease anesthetic exposure to the patient, and minimize radiation exposure to both the operator and the patient.

[0013] Since attempts at re-entry occupy a significant portion of the procedure time for angioplasty and stent placement, reducing the use of operating rooms means cost savings and increased patient processing capacity for hospitals and treatment centers. [Overview of the Initiative] [Means for solving the problem]

[0014] Improved devices, systems, and methods for intravascular imaging are disclosed. An imaging device is disclosed comprising: an extendable catheter body; a first catheter lumen extending through the catheter body; a second catheter lumen extending through the catheter body and separated from the first catheter lumen by a dividing layer; one or more light-transmitting windows defined along the dividing layer; and a catheter exit port defined along a portion of the catheter body and aligned with at least one of the one or more light-transmitting windows.

[0015] The extension catheter body can be configured to advance through the patient's body cavities, such as blood vessels. The catheter body may have a dorsal side and a ventral side opposite the dorsal side. The catheter exit port may be defined along the ventral side of the catheter body.

[0016] A first catheter lumen may be configured to house at least a portion of the imaging components. A second catheter lumen may be configured to house a guide needle having a hollow core with at least a portion of the guide wire or the option of housing the guide wire therein. One or more light-transmitting windows are configured to allow light to pass through one or more light-transmitting windows. In another embodiment, the light-transmitting windows may extend from behind the nearest exit port of the guide needle or guide wire to the entire length of the guide needle or guide wire to the most distal extension range.

[0017] In some embodiments, one or more light-transmitting windows can be made in part from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene. In these and other embodiments, one or more light-transmitting windows can be made in part from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide. Furthermore, one or more light-transmitting windows can be made in part from at least one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), polyethylene terephthalate (PET), etc.

[0018] The catheter exit port can be in fluid communication with the second catheter lumen, allowing the guide needle or guidewire to advance out of the second catheter lumen into the patient's body cavities, such as the patient's blood vessels.

[0019] The catheter exit port can be aligned with at least one of one or more light-transmitting windows (for example, longitudinally and laterally, such that there is at least partial overlap) so that the needle guide or guidewire is within the field of view of the imaging component in the first catheter lumen when the guide needle or guidewire exits the catheter body through the catheter exit port. For example, the guide needle or guidewire may be within the field of view of the imaging component when the guide needle or guidewire extends at least partially through the catheter exit port. The guide needle or guidewire may also be within the field of view of the imaging component when at least a portion of the guide needle or guidewire intersects with a lateral orientation plane positioned along the edge of the catheter exit port.

[0020] Several additional catheter exit ports may also be defined along the ventral side of the catheter body. These additional catheter exit ports may be configured to allow a guide needle or guidewire to advance or exit the second catheter lumen at various positions or locations along the catheter body.

[0021] In some embodiments, the longitudinal or axial displacement of an imaging component can be correlated with the longitudinal or axial displacement of a guide needle or guide wire. For example, the proximal section of the guide needle or guide wire can be coupled to the proximal portion of the imaging component such that the longitudinal or axial displacement of the imaging component also results in the longitudinal or axial displacement of the guide needle or guide wire, and vice versa. In these or other embodiments, the longitudinal or axial displacement of an imaging component can be tracked by one or more encoders positioned along the proximal portion of the imaging component, and the longitudinal or axial displacement of the guide needle or guide wire can also be tracked by the same or different encoders positioned along or around the proximal section of the guide needle or guide wire. In addition, or alternatively, the rotational motion of an imaging component and the rotational motion of a guide needle or guide wire can be tracked by one or more rotary encoders.

[0022] The imaging component can be configured to swing so that it rotates back and forth with respect to the longitudinal rotation axis at a rotation angle of less than 180 degrees (e.g., about 90 degrees to about 180 degrees). In other embodiments, the imaging component can be configured to swing so that it rotates back and forth with respect to the longitudinal rotation axis at a rotation angle of less than 90 degrees (e.g., about 30 degrees to about 90 degrees). In further embodiments, the imaging component can be configured to swing so that it rotates back and forth with respect to the longitudinal rotation axis at a rotation angle less than 360 degrees but greater than 180 degrees. The imaging component may be part of an optical coherence tomography (OCT) imaging system so that the OCT imaging system is configured to perform image alignment on the image captured by the imaging component.

[0023] The imaging component can be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at a constant speed (or a constant target speed) that can be adjusted from 200 revolutions per minute (rpm) to 2,000 rpm. In another embodiment, the imaging component can be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at a constant speed that can be adjusted from 200 revolutions per minute (rpm) to 1,000 rpm. In yet another embodiment, the imaging component can be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at a constant speed that can be adjusted from 200 revolutions per minute (rpm) to 500 rpm. The imaging component may be part of an optical coherence tomography (OCT) imaging system so that the OCT imaging system is configured to perform image alignment on the image captured by the imaging component.

[0024] The imaging component can be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted during operation between 200 revolutions per minute (rpm) and 2,000 rpm. In another embodiment, the imaging component can be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted during operation between 200 revolutions per minute (rpm) and 1,000 rpm. In yet another embodiment, the imaging component can be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted during operation between 200 revolutions per minute (rpm) and 500 rpm. The imaging component may be part of an optical coherence tomography (OCT) imaging system so that the OCT imaging system is configured to perform image alignment on the image captured by the imaging component.

[0025] In some embodiments, one or more light-transmitting windows may be defined along the ventral side of the catheter body. At least one of such light-transmitting windows (i.e., defined along the ventral side of the catheter body) may be aligned with at least one of one or more light-transmitting windows defined along the split layer, such that a section of a guide needle or guidewire extending outward from the catheter exit port and into the blood vessel is within the field of view of the imaging component through the aligned (e.g., longitudinally aligned, laterally aligned, or a combination thereof) light-transmitting window.

[0026] A method of tracking an induction needle or guide wire is also disclosed. The method includes advancing an elongate catheter body through a patient's vasculature. The catheter body includes a first catheter lumen extending through the catheter body and a second catheter lumen extending through the catheter body and separated from the first catheter lumen by a dividing layer. The first catheter can be configured to house at least a portion of an imaging component, and the second catheter lumen can be configured to house at least a portion of a guide wire.

[0027] The method further includes advancing a section of the induction needle or guide wire out from a catheter exit port defined along the ventral side of the catheter body and imaging the displacement of the induction needle or guide wire using light transmitted from an imaging component extending through the first catheter lumen. The light can be transmitted through one or more light transmissible windows defined along the dividing layer. The catheter exit port can be aligned with at least one of the one or more light transmissible windows such that when the induction needle or guide wire extends partially through the catheter exit port, the induction needle or guide wire is within the field of view of the imaging component.

[0028] The method can further include correlating longitudinal or axial displacement of the imaging component with longitudinal or axial displacement of the induction needle or guide wire. For example, a proximal section of the induction needle or guide wire can be coupled to a proximal portion of the imaging component such that longitudinal or axial displacement of the imaging component also results in longitudinal or axial displacement of the induction needle or guide wire, or vice versa. The method can also include tracking longitudinal or axial displacement of the imaging component using one or more encoders positioned along a proximal portion of the imaging component and tracking longitudinal or axial displacement of the induction needle or guide wire using one or more encoders positioned along a proximal section of the guide wire.

[0029] The method can also include oscillating the imaging component within the catheter body such that the imaging component rotates back and forth with respect to the longitudinal rotation axis at a rotation angle of less than 180 degrees (e.g., from about 90 degrees to about 180 degrees). In other embodiments, the imaging component can be oscillated such that the imaging component rotates back and forth with respect to the longitudinal rotation axis at a rotation angle of less than 90 degrees (e.g., from about 30 degrees to about 90 degrees). In further embodiments, the imaging component can be oscillated such that the imaging component rotates back and forth with respect to the longitudinal rotation axis at a rotation angle that is less than 360 degrees but greater than 180 degrees. The imaging component can be part of an optical coherence tomography (OCT) imaging system. The method can further include performing image alignment on the images captured by the imaging component using the OCT imaging system.

[0030] The method can also include continuously rotating clockwise or counterclockwise with respect to the longitudinal axis at a constant speed (or a preset target speed) that can be adjusted to between 200 revolutions per minute (rpm) and 2,000 rpm. In another embodiment, the imaging component can be configured to continuously rotate clockwise or counterclockwise with respect to the longitudinal axis at a constant speed that can be adjusted to between 200 revolutions per minute (rpm) and 1,000 rpm. In yet another embodiment, the imaging component can be configured to continuously rotate clockwise or counterclockwise with respect to the longitudinal axis at a constant speed that can be adjusted to between 200 revolutions per minute (rpm) and 500 rpm. The imaging component can be part of an optical coherence tomography (OCT) imaging system. The method can further include performing image alignment on the images captured by the imaging component using the OCT imaging system.

[0031] The method may also include continuous rotation clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted during operation between 200 revolutions per minute (rpm) and 2,000 rpm. In another embodiment, the imaging component may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted during operation between 200 revolutions per minute (rpm) and 1,000 rpm. In yet another embodiment, the imaging component may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted during operation between 200 revolutions per minute (rpm) and 500 rpm. The imaging component may be part of an optical coherence tomography (OCT) imaging system. The method may further include performing image alignment on the image captured by the imaging component using the OCT imaging system.

[0032] The method may also include advancing a guide needle or guidewire out of one or more additional catheter exit ports defined along the ventral side of the catheter body. The additional catheter exit ports may allow the guide needle or guidewire to advance out of a second catheter lumen at other locations along the catheter body.

[0033] The method may also include imaging a guide needle or guidewire using light transmitted from an imaging element extending through the lumen of a first catheter. The light can be transmitted through a light-transmitting window defined along a split layer and a light-transmitting window defined along the ventral side of the catheter body. The light-transmitting window defined along the ventral side of the catheter body may be aligned with the light-transmitting window defined along the split layer such that a section of the guidewire extending outward from the catheter exit port and into the blood vessel is within the field of view of the imaging element through the aligned light-transmitting window.

[0034] Improved devices, systems, and methods for intravascular weight loss are disclosed. A plaque removal device for removing atherosclerotic material from a blood vessel may comprise a tubular housing coupled to or extending from the distal end of a catheter, a collection chamber coupled to the tubular housing, and an inflatable balloon coupled to the outside of the tubular housing. The tubular housing may comprise a housing lumen configured to be in fluid communication with the catheter lumen of the catheter. The tubular housing may also comprise a cutting window defined along a portion of the tubular housing.

[0035] The tubular housing may further include a rotatable cutter configured to reduce the amount of atherosclerotic material protruding into the cutting window. The rotatable cutter may be coupled to a drive shaft extending through the catheter and the tubular housing. The rotatable cutter may be longitudinally translatable within the housing lumen via the drive shaft.

[0036] The collection chamber can be configured to collect the atherosclerotic material reduced by the rotatable cutter. The collection chamber can be in fluid communication with the housing lumen. In one embodiment, the collection chamber may be a nose cone coupled to the distal end of the tubular housing.

[0037] An inflatable balloon may have a balloon lumen that communicates with the housing lumen, such that fluid introduced into the housing lumen via a catheter lumen inflates the inflatable balloon. In some embodiments, the balloon and tubular housing can substantially restrict fluid flow through the blood vessel when the balloon is inflated.

[0038] The tubular housing may further comprise a dorsal side and a ventral side opposite the dorsal side. The tubular housing may have multiple housing port openings defined along the dorsal side of the tubular housing.

[0039] In some embodiments, the fluid may be a saline solution. More specifically, the fluid may be a heparinized saline solution. In other embodiments, the fluid may contain a contrast agent.

[0040] The tubular housing may further comprise an imaging catheter and an optical fiber wire extending at least partially through the imaging catheter. The optical fiber wire may be configured to image blood vessels and atherosclerotic material surrounding the tubular housing through optical coherence tomography (OCT).

[0041] An inflatable balloon may be equipped with a valve configured to control the entry of fluid into the balloon lumen. The inflatable balloon may further be equipped with one or more drainage holes configured to allow fluid to seep out of the balloon lumen.

[0042] In some embodiments, the valve may be a one-way valve configured to allow fluid flow only into the balloon lumen. In other embodiments, the valve may be a two-way valve configured to allow fluid flow in and out of the balloon lumen.

[0043] A method for reducing the amount of atherosclerotic material in a blood vessel is also disclosed. This method involves introducing a tubular housing of a plaque resection device into a blood vessel containing atherosclerotic material. The tubular housing may be coupled to or extend from the distal end of a catheter. The tubular housing may comprise a housing lumen configured to be in fluid communication with the catheter lumen of the catheter, a cutting window defined along a portion of the tubular housing, and a rotatable cutter.

[0044] This method may also include inflating a balloon attached to the outside of the tubular housing using a fluid introduced into the housing lumen via a catheter lumen. The balloon lumen can be in fluid communication with the housing lumen. This method may further include flushing a vascular compartment adjacent to the tubular housing using a fluid introduced into the housing lumen. Flushing the vascular compartment adjacent to the tubular housing clears the view adjacent to the tubular housing. This method may also include deflating the balloon to rotate the tubular housing of the atherosclerotic device within a blood vessel.

[0045] The method further includes using a rotatable cutter to cut atherosclerotic material extending within the cutting window. The rotatable cutter can be moved longitudinally by moving a drive shaft coupled to the rotatable cutter. The drive shaft can extend through the catheter and tubular housing.

[0046] The method may also include imaging the blood vessels and atherosclerotic material surrounding the tubular housing via optical coherence tomography (OCT) using an imaging catheter and an optical fiber wire extending at least partially through the imaging catheter. The imaging may be performed after or concurrently with the flushing of the blood vessels.

[0047] The tubular housing may further comprise a dorsal side and a ventral side opposite to the dorsal side, and the tubular housing may comprise a plurality of housing port openings defined along the dorsal side of the tubular housing, and flushing a compartment of blood vessels adjacent to the tubular housing with fluid further comprises directing the fluid through the plurality of housing port openings.

[0048] In one embodiment, an extendable catheter body configured to advance through a patient's blood vessel, the catheter body comprising: a dorsal side and a ventral side opposite the dorsal side; a first catheter lumen extending through the catheter body, the first catheter lumen may be configured to house at least a portion of an imaging component; a second catheter lumen extending through the catheter body, the second catheter lumen may be configured to house at least a portion of a guidewire, the second catheter lumen may be separated from the first catheter lumen; and one or more defined between the first and second catheter lumen. An imaging device is provided comprising one or more windows, one or more of which are configured to allow light to pass through one or more windows, and a catheter exit port defined along the ventral side of the catheter body and in fluid communication with a second catheter lumen, the catheter exit port may be configured to allow a guidewire to advance out of the second catheter lumen, and the catheter exit port may be aligned with at least one of the one or more windows such that when the guidewire extends partially through the catheter exit port, the guidewire may be within the field of view of the imaging component. The device further comprises a guide needle slidably positioned within the second catheter lumen, the guide needle having a needle lumen configured to slidably receive a guidewire. The guide needle may have an oblique distal end with an oblique face. The oblique face may be perpendicular to the longitudinal axis of the elongating catheter body. The device further comprises a needle lock which may be configured to reversibly lock the movement of the OCT image to the movement of the guide needle. The longitudinal or axial displacement of the imaging component may be correlated with the longitudinal or axial displacement of the guidewire. The proximal section of the guidewire may be connected to the proximal portion of the imaging component.The longitudinal or axial displacement of the imaging component may be tracked by one or more encoders positioned along the proximal portion of the imaging component, and the longitudinal or axial displacement of the guidewire may be tracked by one or more encoders positioned along the proximal section of the guidewire. The imaging component may be configured to swing so that it rotates back and forth with respect to a longitudinal rotation axis at a rotation angle of less than 180 degrees. The imaging component may be configured to rotate during operation at a constant speed that may be adjustable with respect to the longitudinal rotation axis at less than 2,000 rpm. The imaging component may be configured to rotate during operation at various speeds with respect to the longitudinal rotation axis at less than 2,000 rpm. The device may further include an additional catheter exit port defined along the ventral side of the catheter body, which is configured to allow the guidewire to advance out of the second catheter lumen at various positions along the catheter body. The device may further include one or more windows defined along the ventral side of the catheter body, at least one of the one or more windows defined along the ventral side of the catheter body may be aligned with at least one of the one or more windows defined along the split layer such that a section of the guidewire extending outward from the catheter exit port and into the blood vessel may be within the field of view of the imaging component through the window. One or more windows may be partially made from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene. One or more windows may be partially made from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide.One or more windows may be made in part from at least one of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET). The apparatus according to claim 1, wherein the imaging component may be part of an optical coherence tomography (OCT) imaging system, and the OCT imaging system may be configured to perform image alignment on the image captured by the imaging component.

[0049] In another embodiment, an extendable catheter body configured to advance through a patient's blood vessel, the catheter body comprising: a dorsal side and a ventral side opposite to the dorsal side; a first catheter lumen extending through the catheter body, the first catheter lumen configured to house at least a portion of an imaging component; a second catheter lumen extending through the catheter body, the second catheter lumen configured to house at least a portion of a guidewire, the second catheter lumen separated from the first catheter lumen; and one or more windows defined between the first and second catheter lumen, the one or more windows allowing light to enter one or more An imaging apparatus is provided comprising a catheter exit port having fluid communication with a second catheter lumen, and having one or more windows configured to allow transmission through a window thereon, wherein the catheter exit port has an orientation perpendicular to the longitudinal axis of the extension catheter body and a longitudinal position that can be spaced proximal to the distal end of the first catheter lumen, and the catheter exit port may be configured to allow a guidewire to advance out of the second catheter lumen, and the catheter exit port may be aligned with at least one of the one or more windows such that when the guidewire extends partially through the catheter exit port, the guidewire may be within the field of view of the imaging component. The apparatus according to claim 18 further comprises a guide needle slidably positioned in the second catheter lumen, the guide needle having a needle lumen configured to slidably receive a guidewire.

[0050] In another embodiment, the extension catheter body is advanced through the patient's blood vessel, the catheter body comprising: a first catheter lumen extending through the catheter body, the first catheter lumen configured to house at least a portion of the imaging components; and a second catheter lumen extending through the catheter body, the second catheter lumen configured to house at least a portion of the guidewire, the second catheter lumen separated from the first catheter lumen by a dividing layer; and the catheter body A method for tracking a guidewire is provided, comprising advancing a section of the guidewire out of a catheter exit port defined along the ventral side of the catheter, and imaging the guidewire using light transmitted from an imaging element extending through the lumen of a first catheter, wherein the light is transmitted through one or more windows defined along a split layer, and the catheter exit port is aligned with at least one of the one or more windows such that the guidewire is in the field of view of the imaging element when the guidewire partially extends through the catheter exit port. The method may further include advancing a guide needle from a second catheter port, and advancing a section of the guidewire out of the catheter exit port includes advancing a section of the guidewire out of the catheter exit port through the lumen of the guide needle and out of the distal opening of the guide needle. The method may further include engaging a guide needle lock to link the movement of the guide needle and the imaging element together. The guide needle lock may provide a 1:1 movement ratio between the guide needle and the imaging element. The guide needle lock may provide a predetermined variable movement ratio between the guide needle and the imaging component. The method may further include correlating the longitudinal or axial displacement of the imaging component with the longitudinal or axial displacement of the guide wire. The proximal section of the guide wire may be connected to the proximal portion of the imaging component.The method may further include tracking the longitudinal or axial displacement of the imaging element using one or more encoders positioned along the proximal portion of the imaging element, and tracking the longitudinal or axial displacement of the guidewire using one or more encoders positioned along the proximal section of the guidewire. The method may further include oscillating the imaging element within the catheter body so that the imaging element rotates back and forth with respect to the longitudinal axis of rotation at a rotation angle of less than 180 degrees, or rotating the imaging element during operation at a constant speed that may be adjustable with respect to the longitudinal axis of rotation at less than 2,000 rpm. The method may further include rotating the imaging element during operation at various speeds with respect to the longitudinal axis of rotation at less than 2,000 rpm. The method may further include advancing the guidewire out of an additional catheter exit port defined along the ventral side of the catheter body, the additional catheter exit port may be configured to allow the guidewire to advance out of a second catheter lumen at a different location along the catheter body. The method may further include one or more windows defined along the ventral side of the catheter body, at least one of the one or more windows defined along the ventral side of the catheter body may be aligned with at least one of the one or more windows defined along the split layer such that a section of the guidewire extending outward from the catheter exit port and into the blood vessel may be within the field of view of the imaging component through the window. One or more light-transmitting windows may be partially made from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene. One or more windows may be partially made from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide.One or more windows are partially made from at least one of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET). The method according to claim 20, wherein the imaging component may be part of an optical coherence tomography (OCT) imaging system, and the method further includes performing image registration on an image captured by the imaging component using the OCT imaging system.

[0051] In another embodiment, a device for removing atherosclerotic material from a blood vessel is provided, comprising: a tubular housing coupled to or extending from the distal end of a catheter, the tubular housing comprising a housing lumen configured to be in fluid communication with the catheter lumen of the catheter, a cutting window defined along a portion of the tubular housing, and a rotatable cutter configured to reduce atherosclerotic material extending into the cutting window; and a collection chamber coupled to the tubular housing, the collection chamber configured to collect the atherosclerotic material reduced by the rotatable cutter, the collection chamber comprising a collection chamber in fluid communication with the housing lumen; and an inflatable balloon coupled to the outside of the tubular housing, the inflatable balloon comprising a balloon lumen in fluid communication with the housing lumen, such that fluid introduced into the housing lumen via the catheter lumen clears the area adjacent to the cutting window and inflates the inflatable balloon. The tubular housing further comprises a dorsal side and a ventral side opposite the dorsal side, and the tubular housing comprises a plurality of housing port openings defined along the dorsal side of the tubular housing. The fluid may be a saline solution or a contrast agent. The saline solution may be a heparinized saline solution. The tubular housing may further comprise an imaging catheter and an optical fiber wire extending at least partially through the imaging catheter, the optical fiber wire may be configured to image blood vessels and atherosclerotic material surrounding the tubular housing through optical coherence tomography (OCT). The inflatable balloon may further comprise a valve configured to control the entry of fluid into the balloon lumen. The valve may be a one-way valve configured to allow fluid flow only into the balloon lumen. The valve may be a two-way valve configured to allow fluid flow in and out of the balloon lumen. The inflatable balloon may further comprise one or more drainage holes configured to allow fluid to seep out of the balloon lumen. The rotatable cutter may be coupled to a drive shaft extending through the catheter and tubular housing, and the rotatable cutter may be able to move longitudinally within the housing lumen via the drive shaft.The balloon and tubular housing may be configured to substantially restrict fluid flow through the blood vessels when the balloon can be inflated.

[0052] In yet another embodiment, a method is provided for reducing intravascular atherosclerotic material, comprising introducing a tubular housing of a plaque resection device into a blood vessel and in close proximity to atherosclerotic material, wherein the tubular housing is coupled to or extends from the distal end of a catheter and comprises a housing lumen configured to be in fluid communication with the catheter lumen of the catheter, a cutting window defined along a portion of the tubular housing, and a rotatable cutter; inflating a balloon coupled to the outside of the tubular housing using fluid introduced into the housing lumen via the catheter lumen, wherein the balloon lumen of the balloon is in fluid communication with the housing lumen; and flushing the area in close proximity to the tubular housing using fluid introduced into the housing lumen. The method may further include deflating the balloon to rotate the tubular housing of the plaque resection device within the blood vessel. The method may further include imaging the blood vessels and atherosclerotic material surrounding the tubular housing through optical coherence tomography (OCT) using an imaging catheter and an optical fiber wire extending at least partially through the imaging catheter. Flushing the area adjacent to the tubular housing may clear the field of view adjacent to the tubular housing, and imaging may be performed after flushing with fluid. The tubular housing may further comprise a dorsal side and a ventral side opposite to the dorsal side, and the tubular housing may comprise a plurality of housing port openings defined along the dorsal side of the tubular housing, and flushing the vascular compartment adjacent to the tubular housing with fluid further comprises directing the fluid through the plurality of housing port openings. The fluid may be a saline solution or a contrast agent, and the saline solution may be a heparinized saline solution. The balloon may further comprise a valve configured to control the entry of fluid into the balloon lumen. The valve may be a one-way valve configured to allow fluid flow only into the balloon lumen. The valve may be a bidirectional valve configured to allow fluid to flow in and out of the balloon lumen. The balloon may further have one or more drainage holes configured to allow fluid to seep out of the balloon lumen.The method may further include translating a drive shaft, which is coupled to the rotatable cutter, into a longitudinal direction within the tubular housing, the drive shaft extending through the catheter and the tubular housing. The method may further include using the rotatable cutter to cut an atherosclerotic material extending into a cutting window. [Brief explanation of the drawing]

[0053] [Figure 1A] Figure 1A shows a partially exploded perspective view of an embodiment of an imaging device or CTO re-entry device.

[0054] [Figure 1B] Figure 1B shows a partially exploded perspective view of another embodiment of the imaging device or CTO re-entry device.

[0055] [Figure 1C] Figure 1C illustrates a partially exploded perspective view of yet another embodiment of the imaging device or CTO re-entry device.

[0056] [Figure 2A] Figure 2A shows a bottom perspective view of an embodiment of an imaging device or CTO re-entry device with a roughly rectangular ventral exit port.

[0057] [Figure 2B] Figure 2B shows a bottom perspective view of an embodiment of an imaging device or CTO re-entry device with a roughly oval ventral exit port.

[0058] [Figure 3A] Figure 3A shows a side cross-sectional view of an embodiment of an imaging device or CTO re-entry device having a slanted feature positioned proximal to the catheter exit port and light-transmitting window.

[0059] [Figure 3B]Figure 3B shows a side cross-sectional view of an embodiment of an imaging device or CTO re-entry device having a tilted feature located distal to the catheter exit port and light-transmitting window.

[0060] [Figure 3C] Figure 3C shows a bottom perspective view of an embodiment of an imaging device or CTO re-entry device that has an inclined feature positioned close to the catheter exit port.

[0061] [Figure 4] Figure 4 illustrates an embodiment of an imaging system or CTO re-entry device that includes an imaging device.

[0062] [Figure 5A] Figure 5A shows a lateral cross-sectional view of an embodiment of an imaging device or CTO re-entry device.

[0063] [Figure 5B] Figure 5B illustrates exemplary oscillating motion performed by the imaging components of an imaging device or CTO re-entry device.

[0064] [Figure 6A] Figure 6A shows a side cross-sectional view of an embodiment of an imaging device or CTO re-entry device that includes a light-transmitting window aligned with a catheter exit port.

[0065] [Figure 6B] Figure 6B shows a side cross-sectional view of an embodiment of an imaging device or CTO re-entry device with a light-permeable fluid being perfused through perfusion ports defined along the compartment of the imaging device.

[0066] [Figure 6C] Figure 6C illustrates a side cross-sectional view of another embodiment of an imaging device or CTO re-entry device, comprising a plurality of catheter exit ports and at least one of the catheter exit ports aligned with a light-transmitting window defined along a segmented layer.

[0067] [Figure 6D] Figure 6D illustrates a side cross-sectional view of another embodiment of an imaging device or CTO re-entry device, comprising a ventral catheter exit port and at least one ventral window.

[0068] [Figure 6E] Figure 6E illustrates a side cross-sectional view of another embodiment of an imaging device or CTO re-entry device, comprising a ventral catheter exit port, at least one light-transmitting window aligned with the ventral catheter exit port, and a dorsal catheter window aligned with the light-transmitting window.

[0069] [Figure 7A] Figure 7A is a side cross-sectional view of another embodiment of an imaging device or CTO re-entry device equipped with an extendable hollow guide needle.

[0070] [Figure 7B] Figure 7B illustrates exemplary oscillating or rotational motion performed by an imaging component of an imaging device or CTO re-entry device, which provides a wide-angle view for monitoring the angular movement range of the guide needle or guide wire as it exits the exit port.

[0071] [Figure 7C] Figures 7C and 7D depict further embodiments of imaging devices or CTO re-entry devices with inflatable balloons. [Figure 7D] Figures 7C and 7D depict further embodiments of imaging devices or CTO re-entry devices with inflatable balloons.

[0072] [Figure 8] Figures 8A-8F illustrate the use of the imaging device or CTO re-entry device shown in Figures 7A and 7B as an example of operation.

[0073] [Figure 9-1]Figures 9A and 9B illustrate various catheter lumen configurations relating to hollow needle guides and / or guidewires, and the orientation and angular range of exit of the guide needle and / or guidewire relative to the imaging element or lumen location.

[0074] [Figure 9-2] Figures 9C-9N illustrate various lumen sizes, shapes, and orientations. [Figure 9-3] Figures 9C-9N illustrate various lumen sizes, shapes, and orientations.

[0075] [Figure 10-1] Figure 10A depicts an alternative embodiment comprising an imaging device with an offset needle guide or guidewire lumen.

[0076] [Figure 10-2] Figures 10B and 10C depict alternative embodiments comprising an imaging device or CTO re-entry device with an offset needle guide or guidewire lumen. Figure 10B depicts a guidewire inserted into a monorail lumen at the distal end of the catheter to guide the catheter to the target location prior to the intervention. In Figure 10C, the guidewire retracts into the guide needle after the catheter is positioned at the target artery immediately before the intervention, and the guide needle is then deployed for the intervention.

[0077] [Figure 11] Figure 11 illustrates an embodiment of a plaque removal system equipped with a plaque removal device.

[0078] [Figure 12] Figure 12 shows a close-up view of the rotatable cutter of the atherosclerotic plaque removal device during operation.

[0079] [Figure 13] Figures 13A, 13B, and 13C illustrate a normal blood vessel, a blood vessel occluded by concentric plaque, and a blood vessel occluded by eccentric plaque, respectively.

[0080] [Figure 14A] Figure 14A illustrates an embodiment of the atherosclerotic plaque resection device with a balloon in a non-inflatable configuration.

[0081] [Figure 14B] Figure 14B illustrates an embodiment of the atherosclerotic plaque resection device with a balloon in an inflatable occlusion configuration.

[0082] [Figure 15A] Figure 15A shows a cross-sectional side view of an embodiment of atherosclerotic cyst resection device, which includes a housing port opening defined along the dorsal side of the cyst resection device.

[0083] [Figure 15B] Figure 15B shows a cross-sectional side view of an embodiment of a plaque excision device, which includes a valve that controls the fluid flow into the balloon of the plaque excision device.

[0084] [Figure 15C] Figure 15C shows a cross-sectional side view of an embodiment of a plaque resection device comprising an inflatable balloon having an opening defined along the surface of the balloon.

[0085] [Figure 15D] Figure 15D shows a cross-sectional side view of an embodiment of a plaque resection device, which comprises an inflatable balloon having multiple openings defined along the surface of the balloon.

[0086] [Figure 15E] Figure 15E shows a cross-sectional side view of an embodiment of atherosclerotic cyst resection device, which includes a housing port opening defined along the dorsal side of the cyst resection device and a plurality of openings defined along the surface of the balloon.

[0087] [Figure 16A]Figure 16A shows longitudinal and transverse cross-sectional views of an embodiment of a plaque resection device comprising a cutting assembly catheter lumen and an imaging catheter lumen.

[0088] [Figure 16B] Figure 16B shows longitudinal and transverse cross-sectional views of an embodiment of a plaque resection device that includes only an imaging catheter lumen.

[0089] [Figure 17] Figure 17 illustrates a plaque resection device comprising another embodiment of an inflatable balloon having micro-sized drainage holes.

[0090] [Figure 18] Figures 18A-18D illustrate various embodiments of an inflatable balloon for atheroma resection devices. [Modes for carrying out the invention]

[0091] Detailed explanation Imaging system and CTO re-entry device

[0092] Figure 1A illustrates a partially exploded perspective view of an embodiment of the imaging device 100. The imaging device 100 may comprise an extension catheter body 102, a first catheter lumen 104 (see also Figures 5A and 6A-6E) or passage extending through the catheter body 102, and a second catheter lumen 106 (see also Figures 5A and 6A-6E) or passage extending through the catheter body 102. The first catheter lumen 104 may be separated from the second catheter lumen 106 by at least one split layer 108 (partially shown in Figures 1A, 1B, 5A, and 6A-6E). The extension catheter body 102 may be configured to advance through a patient's body cavity, such as a patient's blood vessel. In another embodiment, the imaging device 100 may be a CTO re-entry device.

[0093] As will be discussed in more detail in the following sections, the imaging device 100 can be used to safely deliver a guidewire 112 or another minimally invasive surgical tool to a target site within the patient's body cavity under real-time imaging guidance. The imaging device 100 can track the position of the guidewire 112 even after it has left the lumen of the catheter body 102. In some embodiments, the imaging device 100 can be adapted or configured to work with or integrate with an endovascular surgical device, such as atherosclerotic device. In other modifications, the imaging device 100 may be supplied separately from the guidewire 112, either as part of a kit with the guidewire 112, as a separate accessory, or selected by the user from a range of off-the-shelf guidewires from which the imaging device 100 can be used. In further embodiments described below, the imaging device 100 or CTO re-entry device may further include movable hollow guide needles or hollow needle guides 700, 1020 (Figures 7A-7B and 10A-10C) which can be used in conjunction with guide needles, e.g., guidewires 112, 1022, that are integrated with or pre-placed within the second catheter lumen 106. The hollow guide needles or hollow needle guides may also be supplied as separate components in a kit with the imaging device 100 or CTO re-entry device, or as separate optional accessories to the imaging device 100 or CTO re-entry device.

[0094] The catheter body 102 may be a long, flexible hollow tube configured to allow a guidewire 112, a drive shaft, a pusher element, a wire, a cable, an imaging fiber, or a combination thereof to pass through one or more catheter lumens within the catheter body 102. The catheter lumens may also be used to deliver or otherwise introduce a fluid, a pharmaceutical composition, a contrast agent, or a combination thereof to a target site within a body cavity.

[0095] The catheter body 102 and / or catheter nose 124 may be made in part from a biocompatible polymer material, a biocompatible metallic material, or a combination thereof. In some embodiments, the catheter body 102 or its components may be made from polyamide (e.g., nylon 6, 11, 12, etc.) or polyether block amide (e.g., PEBAX). TM They can be made from polytetrafluoroethylene (PTFE), polycarbonate (PC), polyetherketone (PEEK), polyethersulfone (PES), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polyvinylidene fluoride (PVDF), perfluoroalkoxyalkane (PFA), or combinations thereof. In alternative embodiments, the catheter body 102, parts thereof, or components within it can be made in part from stainless steel. In some modifications, the catheter body 102 and nose cone 124 may contain an optically transparent polymer, and a refractive index of less than 1.60 may be used. Such materials include polyethylene terephthalate (PET) (n=1.575), polyamides such as nylon (n=1.565), polydimethylsiloxane (PDMS) (n=1.4118), fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE) (n=1.403), and PFA. In some further embodiments, optically transparent polymers with a refractive index of less than 1.45, including ETFE, PDMS, PTFE, FEP, and PFA, may be used. In other embodiments, optically transparent polymers with a refractive index of less than 1.40 may be used, such as PTFE (n=1.35~1.38), FEP (n=1.344), and PFA (n=1.344).

[0096] The catheter body 102 may have a certain catheter diameter and a certain catheter length. In some embodiments, the catheter diameter may be about 2.0 mm. In other embodiments, the catheter diameter may be about 1.50 mm to about 2.0 mm or about 2.0 mm to about 2.5 mm. The catheter length may be about 30.0 cm to about 170.0 cm.

[0097] In some embodiments, the first catheter lumen 104 may occupy a portion of the internal space within the catheter body 102, and the second catheter lumen 106 may occupy the remaining portion of the internal space. For example, the first catheter lumen 104 may occupy or be able to occupy half of the internal space within the catheter body 102, and the second catheter lumen 106 may occupy or be able to occupy the other half of the internal space within the catheter body 102.

[0098] In alternative embodiments, the first catheter lumen 104 and the second catheter lumen 106 may be lumens of separate catheters or tubes extending through the catheter body 102. In these embodiments, the segmented layer 108 may be one or more layers or portions of such separate catheters.

[0099] The first catheter lumen 104 may be configured to house or contain at least a portion of the imaging component 110. The second catheter lumen 106 may be configured to house or contain at least a portion of the guidewire 112. The imaging component 110 may be part of an optical coherence tomography (OCT) imaging system. The imaging component 110 may include an imaging sensor 111 coupled to or otherwise attached to the distal portion of the sensor cable 113 or wire. In some embodiments, the imaging sensor 111 may include a section of optical fiber, a refractive index distribution lens, and a microprism configured to generate a focused output beam of light (response measurement beam) propagating laterally with respect to the longitudinal axis of the catheter body 102. In some embodiments, the sensor cable 113 or wire may be configured to rotate (e.g., back and forth) with respect to the longitudinal axis of the sensor cable 113 or wire. In other embodiments, only the distal portion of the sensor cable 113 may be configured to rotate back and forth with respect to the longitudinal axis of the sensor cable 113 or wire. As will be discussed in more detail in the following sections, the sensor cable 113, the imaging sensor 111, or a combination thereof may be configured to swing or rotate back and forth with respect to the longitudinal axis of rotation at rotation angles of less than 360 degrees (more specifically, for example, less than 180 degrees, less than 90 degrees, or less than 45 degrees).

[0100] In another embodiment, the sensor cable 113 may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at a constant speed, which can be adjusted from 200 revolutions per minute (rpm) to 2,000 rpm. In yet another embodiment, the imaging component may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at a constant speed, which can be adjusted from 200 revolutions per minute (rpm) to 1,000 rpm. In yet another embodiment, the imaging component may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at a constant speed, which can be adjusted from 200 revolutions per minute (rpm) to 500 rpm.

[0101] In another embodiment, the sensor cable 113 may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted between 200 revolutions per minute (rpm) and 2,000 rpm during operation. In yet another embodiment, the imaging component may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted between 200 revolutions per minute (rpm) and 1,000 rpm during operation. In yet another embodiment, the imaging component may be configured to rotate continuously clockwise or counterclockwise around the longitudinal axis at various speeds, which can be adjusted between 200 revolutions per minute (rpm) and 500 rpm during operation.

[0102] The guidewire 112 may be a steerable guidewire. The guidewire 112 may have a guidewire diameter of about 0.85 mm. In some embodiments, the guidewire 112 may have a guidewire diameter of about 0.35 mm to about 0.85 mm. In other embodiments, the guidewire 112 may have a guidewire diameter greater than 0.85 mm. As previously stated, the imaging device 100 may be supplied separately from the guidewire 112, either in a kit with the guidewire 112, as a separate accessory, or selected by the user from off-the-shelf guidewires that the imaging device 100 can utilize. In other embodiments, the imaging device 100 or the CTO re-entry device may further include a movable hollow guide needle or hollow needle guide 700, 1020 (Figures 7A-7B and 10A-10C) which may be used in conjunction with a guide needle, e.g., guidewires 112, 1022, that is integrated with or pre-placed in the second catheter lumen 106. The hollow guide needle or hollow needle guide may be integrated with the imaging device 100, or pre-installed therein, or may be supplied as a separate component in a kit with the imaging device 100 or CTO re-entry device, or as a separate optional accessory to the imaging device 100 or CTO re-entry device. One or more light-transmitting windows 120 may be defined along the segmented layer 108 so that light (e.g., infrared or near-infrared light waves) emitted by the imaging component 110 in the first catheter lumen 104 can be transmitted through one or more light-transmitting windows 120. The light-transmitting windows 120 may be embedded in or integrated with the segmented layer 108. In other embodiments, one or more ports or openings may be fabricated along the segmented layer 108, and one or more light-transmitting windows 120 may be attached to the ports or openings using adhesives (e.g., light-transmitting epoxy or resin), fasteners, clips, clasps, interlocking fits, or a combination thereof.The vertical length of the light-transmitting window may be between 5 mm and 150 mm or greater, up to the length of the extension catheter body, or within the range of 30 mm to 100 mm, or 60 mm to 90 mm.

[0103] In some embodiments, one or more light-transmitting windows 120 can be partially made from at least one of transparent polymer materials. For example, one or more light-transmitting windows 120 can be partially made from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene. In these and other embodiments, one or more light-transmitting windows 120 can be partially made from ceramic materials such as fused silica or quartz. In some embodiments, one or more light-transmitting windows 120 can be partially made from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide. In other embodiments, one or more light-transmitting windows may be made in part from at least one or more of the following: polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET).

[0104] The catheter body 102 may have a dorsal side 114 and a ventral side 116 opposite the dorsal side 114. A catheter exit port 118 or access port may be defined along the ventral side 116 of the catheter body 102. The catheter exit port 118 may be in fluid communication with a second catheter lumen 106, allowing a guidewire 112 within the second catheter lumen 106 to advance out of the second catheter lumen 106 and into the patient's body cavity (e.g., a blood vessel).

[0105] The catheter exit port 118 may be aligned with or overlap with at least one of the one or more light-transmitting windows 120. The catheter exit port 118 may be aligned with (for example, aligned longitudinally and laterally) or overlap with at least one of the one or more light-transmitting windows 120 such that catheter components extending through the catheter exit port 118 or part of the environment outside the catheter exit port 118 are optically visible when viewed from the first catheter lumen 104.

[0106] For example, the catheter exit port 118 may be aligned (e.g., aligned longitudinally and laterally) or overlap with at least one of one or more light-transmitting windows 120 such that catheter components extending through the catheter exit port 118 or part of the environment outside the catheter exit port 118 are within the field of view 122 of an imaging component 110 positioned across (or in close proximity to) a light-transmitting window 120 aligned with the catheter exit port 118. In this exemplary embodiment, the imaging component 110 may be positioned within the first catheter lumen 104. More specifically, the catheter exit port 118 may be aligned with or overlap with at least one of one or more light-transmitting windows 120 such that the guidewire 112 is within the field of view 122 of an imaging component 110 within the first catheter lumen 104 when the guidewire 112 exits the second catheter lumen 106 through the catheter exit port 118. Furthermore, the guidewire 112 or another catheter component may be within the field of view 122 of the imaging component 110, which is positioned across a light-transmitting window 120 aligned with the catheter exit port 118, when the guidewire 112 or other catheter component intersects with a lateral orientation plane positioned along the edge of the catheter exit port 118.

[0107] The catheter body 102 may also be equipped with a tapered or substantially conical catheter nose 124 at the distal end of the catheter body 102. The tapered or substantially conical catheter nose 124 may converge to a rounded nose end or a blunt tip so that the catheter nose 124 can be translated or migrated through the patient's blood vessels or other body cavities without causing trauma. The catheter nose 124 may be made from a relatively soft or deformable material to allow the catheter nose 124 to bend or flex. In some embodiments, the catheter nose 124 may be made in part from nylon, silicone rubber, polyurethane, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), latex, thermoplastic elastomer, or a combination thereof.

[0108] Figure 1B illustrates a partially exploded perspective view of another embodiment of the imaging device 100, which includes a dorsal catheter window 126 defined along the dorsal wall of the catheter body 102. As shown in Figure 1B, the dorsal catheter window 126 can be aligned (for example, longitudinally and laterally, such that there is partial overlap) with at least one of the light-transmitting window 120 and the catheter exit port 118. The dorsal catheter window 126 can also be a light-transmitting window so that a reaction measurement light beam or an imaging light beam can be transmitted through the dorsal catheter window 126. In some embodiments, the dorsal catheter window 126 can be made from the same material as the light-transmitting window 120.

[0109] For example, the dorsal catheter window 126 can be made in part from at least one of transparent polymer materials. For example, the dorsal catheter window 126 can be made in part from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene. In these and other embodiments, the dorsal catheter window 126 can be made in part from a ceramic material such as fused silica or quartz. In some embodiments, the dorsal catheter window 126 can be made in part from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide. In other embodiments, the dorsal catheter window 126 can be made in part from at least one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET).

[0110] The dorsal catheter window 126 can allow the imaging component 110 to image a portion of the patient's blood vessels outside the dorsal catheter window 126. For example, the dorsal catheter window 126 can allow the imaging component 110 to image atherosclerotic material deposited in the patient's blood vessels adjacent to the dorsal catheter window 126. As discussed above, the sensor cable 113 of the imaging component 110, the imaging sensor 111 coupled to the distal portion of the sensor cable 113, or a combination thereof can be made to rotate around a longitudinal axis of rotation (e.g., rotate forward and backward, or continuously rotate clockwise or counterclockwise) so that both the ventral catheter exit port 118 (and any guidewire 112 extending through the catheter exit port 118) and the body cavity environment outside the dorsal catheter window 126 can be imaged together.

[0111] Figure 1C shows a partially exploded perspective view of yet another embodiment of the imaging device 100, which has a larger dorsal catheter window 126 than that shown in Figure 1B. In this embodiment, the dorsal section of the catheter body 102 can be configured as the dorsal catheter window 126. For example, the section of the dorsal catheter wall of the catheter body 102 can be made from a light-transmitting material, such as either the light-transmitting window 120 in Figure 1B or the material used to make the dorsal catheter window 126.

[0112] The dorsal catheter window 126 in Figure 1C allows the imaging component 110 to be in close proximity to the dorsal catheter window 126 and to more accurately image the patient's vascular environment outside of it. In alternative embodiments envisioned by this disclosure, one or more circumferential sections of the catheter body 102, including portions of the dorsal and ventral catheter walls, may be partially made from or substituted with a light-transmitting material.

[0113] Furthermore, as shown in Figure 1C, the section of the divided layer 108 can be fabricated from a light-transmitting material such that the light-transmitting window 120 expands relative to the light-transmitting window 120 shown in Figures 1A and 1B. In some embodiments, the light-transmitting window 120 shown in Figure 1C can also be used in or adapted to the imaging device 100 shown in Figures 1A and 1B.

[0114] Figure 2A shows a bottom perspective view of an embodiment of the imaging device 100, which includes a substantially rectangular ventral exit port 118 defined along the ventral side 116 of the catheter body 102. The ventral exit port 118 can be sized to allow a guidewire 112 to easily extend through the ventral exit port 118 and out of the second catheter lumen 106. For example, the ventral exit port 118 may have a certain port occupancy area or a certain port external area. The port occupancy area or external area may exceed the window area of ​​a light-transmitting window 120 that is aligned with the ventral exit port 118.

[0115] The ventral catheter exit port 118 may have a certain port length 200. In some embodiments, the port length 200 may be about 2.0 mm to about 5.0 mm. In other embodiments, the port length 200 may be about 5.0 mm to about 10.0 mm. In additional embodiments, the port length 200 may be greater than 10.0 mm. When the ventral catheter exit port 118 is substantially rectangular, the exit port 118 may have a certain port width. The port width may be less than the diameter of the catheter body 102. More specifically, the port width may be less than half the diameter of the catheter body 102.

[0116] Figure 2B shows a bottom perspective view of an embodiment of the imaging device 100, which includes a substantially oval ventral exit port 118 defined along the ventral side 116 of the catheter body 102. In some embodiments, the oval ventral exit port 118 may be substantially elliptical.

[0117] The oval ventral outlet port 118 may have a certain port area or port external area. The port area or external area may exceed the window area of ​​the light-transmitting window 120 that is aligned with the oval ventral outlet port 118.

[0118] The ventral exit port 118 can be fabricated by laser cutting, mechanical drilling, or a combination thereof. The edges defining or surrounding the ventral exit port 118 can be lined or reinforced. In some embodiments, the edges defining or surrounding the ventral exit port 118 may be beveled or rounded to prevent the guidewire 112 from scratching or snagging as it exits through the ventral exit port 118.

[0119] Figures 3A-3B illustrate side cross-sectional views of an embodiment of the second catheter lumen 106, which includes an inclined feature 300 positioned adjacent to the ventral catheter exit port 118. As shown in Figure 3A, the inclined feature 300 can be positioned proximal to the ventral catheter exit port 118, the light-transmitting window 120, or a combination thereof. The inclined feature 300 can project or extend into the second catheter lumen 106 from the dorsal luminal wall 302 of the second catheter lumen 106.

[0120] Figure 3B illustrates that the inclined feature 300 may be positioned distal to the ventral catheter exit port 118, the light-transmitting window 120, or a combination thereof. In this embodiment, the inclined feature 300 may protrude or extend into the second catheter lumen 106 from the ventral lumen wall 304 of the second catheter lumen 106.

[0121] The inclined feature 300 may be an inclined or gradient structure attached to the dorsal lumen wall 302, the ventral lumen wall 304, or a combination thereof. The inclined feature 300 may also be part of the lumen wall of the second catheter lumen 106, or integrated with the lumen wall.

[0122] The inclination feature 300 can act as an obstacle, obstruction, or guide that directs or pushes the guidewire 112 to advance in a different direction. For example, the inclination feature 300 can act as an obstacle or guide that deflects or otherwise biases the guidewire 112 in a different direction when the guidewire 112 is translated or displaced longitudinally in the distal direction. For example, the inclination feature 300 can act as an obstacle or guide that deflects or otherwise biases the guidewire 112 toward the ventral catheter exit port 118 so that the guidewire 112 advances out of the catheter exit port 118.

[0123] Figure 3C shows a bottom perspective view of an embodiment of the imaging device 100, which includes an inclined feature 300 (for example, the inclined feature 300 shown in Figure 3B) positioned close to the ventral catheter exit port 118. Figures 3A-3C show a catheter body 102 having only one ventral catheter exit port 118 and one inclined feature 300, but this disclosure assumes that the catheter body 102 of the imaging device 100 may have multiple catheter exit ports 118 and multiple inclined features 300 positioned close to the catheter exit ports 118.

[0124] In some embodiments, the inclined feature 300 can be replaced by or complemented by a marker defined along the ventral lumen wall 304. For example, the marker may be a reference marker, partially made from at least one of a metallic material, a polymeric material, or a combination thereof. In a more specific embodiment, the marker may be partially made from at least one of gold, platinum, stainless steel, titanium, nitinol, a carbon-coated polymer, or a combination thereof. The marker can be positioned so that it is visible through one or more light-transmitting windows 120. The marker can alert the operator of the device 100 that the guidewire 112 is approaching the catheter exit port 118 or is about to exit through the catheter exit port 118.

[0125] Figure 4 illustrates an embodiment of an imaging system 400 comprising an imaging device 100. As shown in Figure 4, the catheter body 102 of the imaging device 100 may be a long, flexible tube configured to allow a guidewire 112, imaging components 110, drive shaft, sensor wire or fiber, imaging wire or fiber, cable, protective sheath, components therein, or a combination thereof, to extend or pass through the catheter lumen of the catheter body 102.

[0126] The extension catheter body 102 can also be coupled to a control unit 402 at its proximal end 404. In this embodiment, the distal end 406 of the extension catheter body 102 may be part of an imaging device 100.

[0127] The control unit 402 may include several electromechanical devices or sensors that convert the translation or angular / rotational motion of the guide wire 112, the imaging components 110, or a combination thereof into digital signals or data. For example, the control unit 402 may include one or more linear encoders 408, rotary encoders 410, or a combination thereof.

[0128] One or more linear encoders 408 may be optical linear encoders, mechanical linear encoders, magnetic linear encoders, inductive linear encoders, capacitive linear encoders, or a combination thereof. The linear encoders 408 may be absolute encoders, incremental encoders, or a combination thereof. One or more linear encoders 408 may track or encode the longitudinal / translational movement or displacement of the guidewire 112, the imaging component 110, or a combination thereof, through the catheter lumen of the extension catheter body 102. For example, one or more linear encoders 408 may track or encode the longitudinal / translational movement or displacement of the proximal section of the guidewire 112 and the imaging component 110 (or the sensor cable 113 of the imaging component 110).

[0129] When the longitudinal movement or displacement of both the guidewire 112 and the imaging component 110 is encoded or tracked by the same linear encoder 408 or a separate linear encoder 408 connected to the same controller, the longitudinal movement or displacement of the guidewire 112 and the imaging component 110 can be correlated or associated with each other. For example, the imaging component 110 (or the sensor cable 113 of the imaging component 110) can be translated longitudinally (e.g., distally) by a certain distance through the first catheter lumen 104 so as to be tracked or encoded by the linear encoder 408, and the guidewire 112 can subsequently or simultaneously be translated longitudinally (e.g., in the same distal direction) by the same distance through the second catheter lumen 106 so as to be tracked or encoded by the same linear encoder 408 or another linear encoder 408 in the control unit 402. In some embodiments, the guidewire 112 can be translated a certain distance outward from the catheter body 102 (e.g., through the ventral catheter exit port 118) so as to be tracked or encoded by the linear encoder 408, and the imaging component 110 can be translated the same distance longitudinally through the first catheter lumen 104 so as to be tracked or encoded by the same linear encoder 408 or another linear encoder 408, simultaneously or subsequently.

[0130] In these and other embodiments, the control unit 402 may also comprise one or more rotary encoders 410. One or more rotary encoders 410 may be absolute rotary encoders, incremental rotary encoders, or a combination thereof. One or more rotary encoders 410 may be optical rotary encoders, mechanical rotary encoders, magnetic rotary encoders, capacitive rotary encoders, or a combination thereof. One or more rotary encoders 410 may track or encode the rotation or angular position of the guidewire 112, the imaging component 110, or a combination thereof. When the angular position or rotation of both the guidewire 112 and the imaging component 110 is encoded or tracked by the same rotary encoder 410 or separate rotary encoders 410 connected to the same controller, the angular position or rotation of the guidewire 112 and the imaging component 110 may be correlated or associated with each other as the guidewire 112 and the imaging component 110 move through the catheter lumen of the catheter body 102.

[0131] As shown in the inset of Figure 4, the proximal section of the guidewire 112 can also be connected to the proximal section of the imaging component 110 (e.g., the sensor cable 113 of the imaging component 110). For example, the proximal section of the guidewire 112 can be physically connected to the proximal section of the sensor cable 113 using a clamp 412, fastener, clip, or other mechanical fastener. Connecting the guidewire 112 to the imaging component 110 can facilitate correlation between the longitudinal translation of the guidewire 112 and the longitudinal translation of the imaging component 110. Figure 4 shows the guidewire 112 connected to the imaging component 110 within the control unit 402, but it is assumed by this disclosure that the guidewire 112 may be connected to the imaging component 110 outside the control unit 402, or even to an imaging component 110 proximal to the control unit 402.

[0132] In some embodiments, the control unit 402 can be configured as a handle or a handheld unit. In other embodiments, the control unit 402 can be configured as a control box or a desktop unit. The control unit 402 may also include a motor and drive assembly.

[0133] The motor and drive assembly can be configured to translate the guide wire 112, the imaging component 110, or a combination thereof, longitudinally (for example, distally, proximally, or a combination thereof). The motor and drive assembly can provide torque or rotate the proximal section of the imaging component 110 (or the proximal section of the sensor cable 113). For example, the motor and drive assembly can be configured to oscillate the imaging component 110 by partially rotating it back and forth with respect to a longitudinal rotation axis. The motor and drive assembly can also provide torque or rotate the proximal section of the guide wire 112.

[0134] The extension catheter body 102 can also be used to deliver or otherwise introduce fluids, pharmaceutical compositions, contrast agents, or combinations thereof to the imaging device 100, a target treatment site adjacent to the imaging device 100 (e.g., a target vascular site in the patient's body), or a combination thereof.

[0135] In some embodiments, such fluids, pharmaceutical compositions, and / or contrast agents may be introduced through a fluid entry port 414 of a Y-fitting or Y-connector 416 defined along the catheter body 102, coupled to it, or in fluid communication with it. In other embodiments, such fluids, pharmaceutical compositions, and / or contrast agents may be introduced through other connections or ports along the catheter body 102.

[0136] The control unit 402 can also be coupled to a computing device 418. The computing device 418 may be part of the imaging system 400. In some embodiments, the computing device 418 may be a desktop computer, a laptop computer, a tablet device, or a combination thereof. The computing device 418 may comprise a central processing unit (CPU) and several memory units. The CPU may have a 32-bit processor data bus or a 64-bit processor data bus. The CPU may be a dual-core, quad-core, or other multi-core processor. The CPU may operate at a speed of 3 GHz or higher. The memory units may comprise random access memory (RAM) and read-only memory (ROM). More specifically, the memory units may comprise dynamic RAM (DRAM), static RAM (SRAM), synchronous DRAM (SDRAM), double data rate (DDR) SDRAM, double data rate 2 (DDR2) SDRAM, or a combination thereof. The computing device 418 may comprise a graphical processing unit (GPU) to provide additional and supplemental image processing power. The GPU may comprise at least 4GB of frame buffer or memory, a base clock of at least 1GHz, a boost clock of at least 1GHz, more than 250 tensor core accounts, and more than 2,000 Computation Integrated Device Architecture (CUDA) core accounts. In another embodiment, the CPU and / or GPU may further comprise an advanced RISC machine (ARM). In another embodiment, the computing device 418 comprises a data acquisition board having a sampling rate of at least 150 megasamples per second. The computing device 418 may also comprise an FPGA or ASIC in conjunction with or instead of the CPU and / or GPU.

[0137] The computing device 418 can process and store images captured by the imaging component 110. The imaging component 110 and the computing device 418 can be combined with other devices to form part of an OCT imaging system. For example, the OCT imaging system may be a common-path OCT system, a time-domain OCT system, a spectral-domain OCT system, or a combination thereof. The computing device 418 can be coupled to a photodetector configured to detect light reflected back from a target. The photodetector, along with the light source, can be housed in the control unit 402.

[0138] The computing device 418 may also be configured to perform image registration on images captured by the imaging component 110. For example, image registration may involve establishing correspondences between features in a set of images, using one or more transformation models, and inferring correspondences of additional features that are detached from such features. Image registration may also be referred to as image matching. Image registration may also be performed to match or map images acquired from different imaging modalities (e.g., OCT with intravascular ultrasound (IVUS) or OCT with fluoroscopy).

[0139] Figure 5A shows a lateral cross-sectional view of an embodiment of an imaging device 100, which includes an imaging component 110 configured to swing with respect to a vertical rotation axis 500.

[0140] As discussed above, the imaging component 110 may be part of an OCT imaging system. The imaging component 110 may comprise an imaging sensor 111, which is coupled to or otherwise attached to the distal portion or section of a sensor cable 113 or wire. In some embodiments, the imaging sensor 111 may comprise a section of optical fiber, a refractive index distribution lens, and a microprism configured to generate a focused output beam of light (response measurement beam) propagating transversely to the longitudinal axis of the catheter body 102.

[0141] OCT is an infrared-based imaging modality that can be used to generate cross-sectional images of vascular walls and / or deposited plaque with sufficient resolution and contrast to enable clinicians or surgeons to identify features associated with plaque. For example, such features may include fibrous plaque, lipid-rich plaque, calcium deposits, macrophages, cholesterol crystals, red / white thrombi, or a combination thereof. OCT imaging can be performed in situ and in real time.

[0142] Images acquired through OCT can have an axial resolution of approximately 1 μm to 15 μm, which is one to two orders of magnitude higher than conventional ultrasound (e.g., intravascular ultrasound (IVUS)). The imaging component 110 can generate a light response measurement beam and project the beam of light into tissue or onto other objects within the field of view 122 of the imaging component 110. In some embodiments, a technique known as interferometry is used to determine the path length of the light response measurement beam that is incident on the tissue or object to be imaged. A light source (e.g., housed in a control unit 402) can generate near-infrared or infrared light having a wavelength of approximately 800 nm to approximately 1.5 μm. The light source can be connected to the imaging sensor 111 or optical emitter via an optical fiber cable or wire, such as a single-mode optical fiber. In some embodiments, the optical fiber cable can be part of the sensor cable 113, wound around the sensor cable 113, or extend through the lumen of the sensor cable 113. In one embodiment, the interferometer can split light generated by a light source into two beams, then direct one beam into the tissue or object to be imaged, and the other beam to a reference mirror positioned at a known location relative to the beam source. The light returning from both the tissue and the reference mirror is incident on a detector (e.g., located within a control unit 402), where it is combined again, and the interference between the two beams is determined. A property of the light known as the "coherence length" determines the depth resolution of the OCT imaging system.

[0143] Figure 5B illustrates an exemplary oscillating motion 502 performed by the imaging component 110 of the imaging device 100. For example, a sensor cable 113 having an imaging sensor 111 coupled to the distal portion of the sensor cable 113 can be rotated with respect to a longitudinal rotation axis 500. The sensor cable 113 can be oscillated such that the sensor cable 113 and the imaging sensor 111 rotate back and forth at a rotation angle 504 of less than 180 degrees. For example, the sensor cable 113 can be oscillated such that the sensor cable 113 and the imaging sensor 111 rotate back and forth at a rotation angle 504 of about 30 degrees to about 90 degrees. In other embodiments, the sensor cable 113 can be oscillated such that the sensor cable 113 and the imaging sensor 111 rotate back and forth at a rotation angle 504 of about 90 degrees to 180 degrees. In a further embodiment, the sensor cable 113 can be oscillated so that the sensor cable 113 and the imaging sensor 111 rotate back and forth within a rotation angle 504 of approximately 180 to 360 degrees. Oscillating the imaging component 110, rather than rotating it continuously (i.e., 360 degrees), can reduce wear and tear on the imaging component 110 (including wear and tear on the optical fiber wire or cable and other components of the imaging component 110).

[0144] As shown in Figures 5A and 5B, the optical response measurement beam can be directed towards or aimed at the ventral side 116 of the catheter body 102. In these embodiments, the guidewire 112 and catheter exit port 118 may be within the field of view 122 of the imaging component 110 as the optical response measurement beam sweeps across the guidewire 112 and catheter exit port 118. As shown in Figure 5A, the optical response measurement beam can pass through a light-transmitting window 120 defined along the splitting layer 108. In other embodiments (e.g., as shown in Figure 6E), the imaging component 110 (including the sensor cable 113 and the imaging sensor 111) can be rotated 180 degrees or more so that the optical response measurement beam is directed towards or aimed at the dorsal side 114 of the catheter body 102. In these embodiments, the catheter body 102 may have a dorsal catheter window 126 (see Figures 1B, 1C, and 6E) positioned along the dorsal side 114 of the catheter body 102. Once the light response measurement beam is directed or aimed toward the dorsal side 114 of the catheter body 102, the imaging component 110 (including the sensor cable 113 and the imaging sensor 111) may be oscillated so that the sensor cable 113 and the imaging sensor 111 rotate back and forth within a rotation angle 504 of approximately 30 to 180 degrees (wherein the light is generally directed toward the dorsal side 114 of the catheter body 102).

[0145] Figure 6A illustrates a side cross-sectional view of an embodiment of the imaging device 100, which includes a light-transmitting window 120 aligned (for example, longitudinally and laterally, such that there is at least partial overlap) with a ventral catheter exit port 118. As shown in Figure 6A, the imaging device 100 may comprise an extendable catheter body, a first catheter lumen 104 extending through the catheter body 102, and a second catheter lumen 106 extending through the catheter body 102. The second catheter lumen 106 may be separated from the first catheter lumen 104 by a dividing layer 108. The light-transmitting window 120 may be defined along the dividing layer 108. The catheter exit port 118 is defined along the ventral side 116 of the catheter body 102 and can allow a guidewire 112, which is housed (or at least partially housed) within the second catheter lumen 106, to advance through the catheter exit port 118 and exit (at least partially) from the catheter body 102.

[0146] As shown in Figure 6A, the alignment of the light-transmitting window 120 with the ventral catheter exit port 118 (e.g., longitudinal and lateral alignment such that at least partial overlap exists) can allow light emitted by the imaging component 110 (e.g., near-infrared or infrared light) to pass through the light-transmitting window 120 so that the catheter exit port 118 and any components passing through the catheter exit port 118 (e.g., guidewire 112) are within the field of view 122 of the imaging component 110.

[0147] In some embodiments, the imaging component 110 may be configured to swing so that it rotates back and forth with respect to a longitudinal rotation axis 500 at a rotation angle 504 (see Figures 5A and 5B) of less than 180 degrees (e.g., about 30 degrees to about 180 degrees). As discussed above, the imaging component 110 may be part of an optical coherence tomography (OCT) imaging system, and the part of the imaging component 110 that swings or rotates may be a sensor cable 113 of the imaging component 110, such as an optical fiber cable or a cable / wire that protects or houses the optical fiber cable. In some embodiments, the distal end of the sensor cable 113 may be swingable or rotated.

[0148] As discussed above, the light-transmitting window 120 can be made in part from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene. In these and other embodiments, the light-transmitting window 120 can be made in part from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide. In other embodiments, the light-transmitting window can be made in part from at least one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET).

[0149] Figure 6A also illustrates that the imaging device 100 may have a plurality of perfusion ports 600 defined along the length of the catheter body 102. The perfusion ports 600 can be positioned close to the catheter exit port 118. The perfusion ports 600 can also be positioned close to any light-transmitting window defined along the catheter body 102 (e.g., a dorsal catheter window 126 or a ventral catheter window 606, see Figures 6D and 6E).

[0150] Figure 6B shows a side cross-sectional view of an embodiment of the imaging device 100, with a light-permeable fluid 602 being perfused through a plurality of perfusion ports 600 defined along the ventral 116 and dorsal 114 of the catheter body 102.

[0151] The perfusion port 600 can be in fluid communication with one or more lumens within the catheter body 102. For example, the perfusion port 600 can be in fluid communication with a first catheter lumen 104, a second catheter lumen 106, or a combination thereof. In some embodiments, a subset or some of the perfusion ports 600 can be in fluid communication with the first catheter lumen 104, and another subset or the remainder of the perfusion ports 600 can be in fluid communication with the second catheter lumen 106.

[0152] As shown in Figure 6B, the fluid 602 can fill, or at least partially fill, the first catheter lumen 104, the second catheter lumen 106, or a combination thereof, and perfuse out of the catheter body 102 through the perfusion port 600 into the target vascular site surrounding the imaging device 100. The fluid 602 can also exit the catheter body 102 through the catheter exit port 118.

[0153] As discussed above, the imaging component 110 may be part of an OCT imaging system. OCT is an infrared light-based imaging modality. A major challenge faced when performing intravascular OCT is the high light-scattering properties of blood, which causes significant attenuation of the OCT imaging signal and hinders clear imaging of the vessel wall. To overcome this challenge, blood in the imaging field 122 must first be cleared using a light-permeable fluid or medium. Multiple perfusion ports 600 can allow the light-permeable fluid 602 to be distributed more uniformly within the vessel, flushing and removing or otherwise displacing the blood in the imaging field 122. Multiple perfusion ports 600 can also help regulate the pressure within the catheter body 102.

[0154] Imaging of the guidewire 112 or the target vessel site (including atherosclerotic material deposited within the target vessel site) can be performed after flushing the target vessel site with a light-permeable fluid 602. In addition, imaging of the guidewire 112 or the target vessel site (including atherosclerotic material deposited within the target vessel site) can be performed simultaneously with or at the same time as flushing.

[0155] In some embodiments, the light-permeable fluid 602 may be a saline solution. For example, fluid 602 may be a 0.90% sodium chloride (NaCl) solution. Alternatively, fluid 602 may be a 0.45% NaCl solution or a solution containing about 0.45% to about 0.90% NaCl. In other embodiments, fluid 602 may be a heparinized saline solution or a saline solution containing the anticoagulant heparin. Heparinized saline solution may be used to prevent coagulation or to prevent occlusion from forming at or within a target vascular site.

[0156] In further embodiments, fluid 602 is or can contain Ringer's lactate solution (also known as RL or LR solution). Ringer's lactate solution may contain a mixture of sodium chloride, sodium lactate, potassium chloride, and calcium chloride in water. In additional embodiments, fluid 602 may contain a contrast agent or dye. For example, fluid 602 is or can contain 30% or 60% iodixanol in Ringer's lactate solution or another type of saline solution (e.g., 0.90% NaCl solution). Furthermore, fluid 602 is or can contain 30% iohexol in Ringer's lactate solution or another type of saline solution (e.g., 0.90% NaCl solution). In other embodiments, fluid 602 is or can contain 5% dextran in Ringer's lactate solution or another type of saline solution (e.g., 0.90% NaCl solution).

[0157] Figure 6C illustrates a side cross-sectional view of another embodiment of the imaging device 100, which includes a plurality of ventral catheter exit ports 118. At least one of the ventral catheter exit ports 118 can be aligned with at least one of a light-transmitting window 120 defined along the split layer 108. The additional exit ports 118 can allow the guidewire 112 to advance or exit from the second catheter lumen 106 at different locations along the catheter body 102. The operator of the imaging component 110, the guidewire 112, or a combination thereof (e.g., a surgeon or other medical professional) can select the catheter exit port 118 through which the guidewire 112 will advance to exit the catheter body 102.

[0158] Figure 6C also illustrates that the imaging device 100 may include a layer opening 604 defined along the divided layer 108. The layer opening 604 performs the same function as the light-transmitting window 120, but can allow a fluid or other component or wire / cable extending through the first catheter lumen 104 to reach the second catheter lumen 106 (or vice versa).

[0159] Figure 6D illustrates a side cross-sectional view of another embodiment of the imaging device 100, comprising a ventral catheter exit port 118 and at least one ventral catheter window 606. In some embodiments, the ventral catheter window 606 may be fabricated from the same material as the light-transmitting window 120 defined along the divided layer 108. In other embodiments, the ventral catheter window 606 may be fabricated from a different material than the light-transmitting window 120 defined along the divided layer 108. The ventral catheter window 606 may be aligned (longitudinally and laterally, with at least some overlap) with at least one of the light-transmitting window 120 or layer opening 604 defined along the divided layer 108. This allows the imaging component 110 to image the guidewire 112 as it moves out of the catheter body 102 and forward away from the ventral catheter exit port 118.

[0160] Figure 6E illustrates a side cross-sectional view of another embodiment of the imaging device 100 extending into a patient's body cavity (e.g., a blood vessel 608). As shown in Figure 6E, the blood vessel 608 may have atherosclerotic material 610 (e.g., calcified plaque) deposited along the wall of the blood vessel 608.

[0161] The imaging device 100 may include a dorsal catheter window 126 defined along the dorsal side 114 of the catheter body 102. The dorsal catheter window 126 may allow the imaging component 110 to image the vascular wall or atherosclerotic material 610 outside the dorsal catheter window 126. As discussed above, the imaging component 110 (including the sensor cable 113 and the imaging sensor 111) may be rotated 180 degrees or more so that the optical response measurement beam is directed or aimed toward the dorsal side 114 of the catheter body 102. Once the light response measurement beam is directed or aimed towards the dorsal side 114 of the catheter body 102, the imaging component 110 (including the sensor cable 113 and the imaging sensor 111) can be oscillated so that the sensor cable 113 and the imaging sensor 111 rotate back and forth at a rotation angle 504 of approximately 30 to 180 degrees (wherein the light is generally directed towards the dorsal side 114 of the catheter body 102). The imaging component 110 can then be rotated again (for example, 180 degrees), and the light response measurement beam can be directed or aimed again towards the ventral side 116 of the catheter body 102, allowing imaging of the opposite vessel wall and the atherosclerotic material 610 deposited on the opposite vessel wall. In this way, the imaging device 100 can be adapted to image concentric and eccentric plaque accumulations.

[0162] In another embodiment of the imaging device 100, as depicted in Figures 7A and 7B, the imaging device includes a voluntary guide needle 700 which can be used to facilitate the re-entry of a guidewire such as returning to the true lumen of a vascular lumen or other anatomical location. In this embodiment, the imaging device 100 may further include a catheter body 102 similar to the embodiment generally described with respect to Figures 1A-6E, a first catheter lumen 104, and a second catheter lumen 106, except that the imaging device further includes a guide needle 700 slidably positioned within a second catheter lumen 106. The guide needle 700 may have a retracted configuration in which its distal tip 706 is located near or proximal to the catheter exit port 118, and an extended configuration in which its distal tip extends beyond the catheter exit port 118. The guide needle 700 may include a guidewire lumen 702 containing a metal such as stainless steel (SS304 or SS316) or nitinol or a combination thereof, in which the guidewire 112 may be slidably present. The guidewire lumen 702 may have a diameter of 0.10 inches or greater, or 0.014 inches or greater, up to 0.035 inches, ±0.02 inches or ±0.04 inches. The guide needle 700 may have a substantially linear configuration but may include an angled distal compartment 704, which may facilitate the exit of the needle tip 706 from the catheter exit port 118. The angled distal compartment 705 may have an angle in the range of approximately 1 to 90 degrees, 5 to 45 degrees, or 10 to 20 degrees from the longitudinal axis of the needle body. The needle tip 706 may be an oblique needle tip with an oblique surface, which may be oriented either parallel or perpendicular to the longitudinal axis of the catheter body 102. Orthogonal bevels can facilitate penetration of the needle tip 706 into adjacent tissue, while parallel bevels can facilitate blunt dissection through adjacent tissue. The needle tip 706 may also have a blunt end configuration. The guide needle 702 may be configured with a mechanical stopper to limit the distance the guide needle 700 can extend from the catheter exit port 118. The mechanical stopper may be user-adjustable to set a procedure-specific extension limit. A measurement mark may be provided on the proximal end of the guide needle 700 to indicate the extension distance from the catheter exit port 118.In some modifications, the guide needle 700 may be pre-positioned in the second catheter lumen 106 at the time of manufacture or use, while in other embodiments, the guide needle 700 may be inserted into the second catheter lumen 106 after the procedure has commenced and after the imaging device 100 has been inserted. A rigid insertion guidewire may be inserted into the guide needle 700 to straighten the angled distal compartment 704 during loading or insertion into the imaging device 100 and to reduce the risk of damage from the angled distal compartment 704 to the second catheter lumen 106. The angled distal compartment 704 may have a longitudinal length in the range of approximately 3–15 mm, 5–10 mm, or 4–8 mm.

[0163] In some modifications, due to the length of the imaging device 100 and the corresponding length of the guide needle 700, the guide needle 700 may have a tendency to be torqued in a rotatable manner to an angular orientation different from the orientation desired by the user, or to move abruptly. In some further modifications, the guide needle 700 may have a non-circular outer circumference along its catheter body or distal portion, e.g., oval, square, rectangular, triangular, trapezoidal, or other polygonal shape, along with a complementary fitting in the second catheter lumen 106 or catheter exit port 118, to help maintain the guide needle 700 within a predictable angular orientation range. Alternatively, in some modifications, a groove or notch in the second catheter lumen 106 or catheter exit port 118 may be sufficient to maintain the angular orientation of the guide needle 700 within a desired range, while still having a circular cross-sectional shape, in conjunction with the angled distal section 706. The acceptable range of angular orientation 708 of the guide needle 700 as it exits the catheter exit port 118 may be configured such that the range of angular orientation 708 is within the field of view 122 of the imaging component 110, as depicted in Figure 7B.

[0164] In some further modifications, the angled distal section 704 and / or distal tip 706 of the guide needle 700, and optionally, a portion of the main needle body, may be provided with a gold or other radiopaque coating. The gold coating may enhance the visibility of the angled distal section 704 and / or distal tip 706. In some embodiments, the gold coating may have a thickness in the range of 50–5,000 nm, 50–1,000 nm, or 50–100 nm to provide visibility using an OCT imaging system, or in the range of 3–30 microns, 3–10 microns, or 3–5 microns for visibility using fluoroscopy and OCT.

[0165] In some modifications, the proximal end of the guide needle 700 may be configured with a connector so that the guide needle 700 can be flushed with saline or other biocompatible fluid. The fluid selected for flushing may have a refractive index in the range of 1.3 to 1.7, 1.3 to 1.5, or 1.3 to 1.4.

[0166] During the procedure, the guide needle 700 and the imaging component 110 may move forward or backward independently of each other. The guide needle 700 or the imaging component 110 may move forward by converting rotational motion into longitudinal motion via a gear drive system. The gear drive system may be designed so that the longitudinal displacement can differ for each full rotation. For example, the imaging component 110 may be displaced longitudinally by 3 mm to 10 mm for each full rotation, while the guide needle may be displaced longitudinally by 1 mm to 5 mm for each full rotation. The rotational motion may be performed manually using a direction change knob or using a motor. With regard to the motor control approach, forward and reverse switches or buttons may be used to operate the motor. The guide needle 700 and the imaging component 110 may have separate motorized actuators. In one embodiment, the longitudinal speeds for the guide needle and the imaging component may differ. The imaging component 110 may be started at 3 mm / sec to 10 mm / sec, while the guide needle may be started at 1 mm / sec to 5 mm / sec. In another embodiment, when the guide needle is ready to be deployed outside the catheter, as described in Figure 8C, the guide needle 700 and the imaging component 110 may be selectively locked prior to deployment. The locking function allows or commands the imaging component 110 and the guide needle 700 to move forward and backward at a fixed travel ratio. The guide needle 700 and the imaging component 110 may move forward or backward at the same speed. The imaging component 110 may monitor the direction of movement of the tip or body of the guide needle 700. In another variation, to facilitate keeping the needle tip 706 within the field of view of the imaging component 110, a mechanical movement lock, such as a clamp, may be selectively or reversibly engaged at the proximal ends of the guide needle 700 and the imaging component 110 so that the movement of the guide needle 700 will also move the imaging component 110, in order to simplify the alignment of the field of view and the needle. A mechanical movement lock, such as a clamp, may provide a one-to-one correspondence between the movement of the two components, but in another embodiment, gears and a gear path system may be provided to provide a predetermined mechanically variable ratio of movement between the two components.The variable ratio movement lock can further facilitate alignment of the two components when the needle tip 706 moves at a certain angle, for example, when the vertical distance per unit of linear movement is reduced while the imaging component 110 is displaced only in the vertical direction. For example, in some embodiments, the vertical range of the guide needle 700 may be configured to be less than 30 mm, less than 20 mm, or less than 15 mm, while the corresponding movement ranges of the imaging components may be less than 50 mm, less than 40 mm, or less than 35 mm, respectively, while the movement of the guide wire 112 moves freely in the vertical direction without constraint by the imaging device 100. However, in other embodiments, the guide wire 112 may also be reversibly or selectively locked to the guide needle 700 and / or the imaging component 110.

[0167] Referring here to Figures 8A-8F, the use of the imaging device 100 with a guide needle 700 is depicted. The patient is prepared in a standard sterile manner, covered with a drape, and sedated. Percutaneous access is achieved (e.g., femoral or radial artery), the introducer is inserted, and the guidewire is advanced toward the target site. If the guidewire 112 exits the true lumen 800 as a result of a plaque or other obstruction 802 and is in the subluminal space or vessel wall 804, as depicted in Figure 8A, the imaging device 100 is advanced along the guidewire 112 while imaging the surrounding anatomical structures to identify when the true lumen 800 is identified distal to the obstruction 802. In Figure 8B, the guidewire 112 is withdrawn and retracted into the guide needle 700, and in Figure 8C, the guide needle 700 is advanced along the second catheter lumen 106 at an angle outward from the catheter exit port 118, in conjunction with the movement of the imaging component 110 in the first catheter lumen until access to the true lumen 800 is achieved again. As described above, the needle 700 and the imaging component 110 may be selectively locked to provide a fixed movement ratio as the needle 700 is advanced. In Figure 8D, the same or a different guidewire 112 is advanced through the lumen 702 of the guide needle 700 until the desired length of the guidewire 112 is inserted. In Figure 8E, the needle 700 is then withdrawn into the imaging device 100, and the imaging component 110 is also withdrawn along with it, maintaining the needle tip 706 in the field of view to confirm full guide needle withdrawal. Once 700 is fully withdrawn, the movement lock may be engaged or disengaged. As shown in Figure 8F, the imaging device 100 can be withdrawn and removed from the body while holding the guidewire 112 in place. This part of the procedure may be repeated as necessary for any subsequent obstacles 800 encountered. The guidewire 112 may then be advanced further to the target location, and any therapeutic procedures, if present, may then be performed. Upon completion of the procedure, the catheter and guidewire may be withdrawn and hemostasis achieved at the insertion site.

[0168] As described above with respect to Figure 7B, in some embodiments of the imaging device 100, the first catheter lumen 104 and the second catheter lumen 106 will be configured symmetrically along the midline of the catheter body 102. This is also depicted in Figure 9A, where the catheter body 900a comprises a first catheter lumen 902a for the imaging device and a second catheter lumen 904a for the guidewire or guide needle. The catheter exit port 906b between the second catheter lumen 904a and the outer surface 908 and the catheter exit port of the catheter body 900a may also be configured symmetrically along the midline. In other embodiments, as depicted in Figure 9B, the catheter body 900b may also include a second catheter lumen 904b, which is offset from the centerline and / or rotated in orientation relative to the first catheter lumen 902b, such that the catheter exit port 906b is also rotated and moves away from the centerline 908b between the center of the first catheter lumen 902b and the catheter body 900b. In contrast to the centerline exit direction 910a with respect to the guide needle or guidewire configured for the catheter body 900a in Figure 9A, the exit direction 910b for the catheter body 900b is 90 degrees or perpendicular to the centerline. In other embodiments, other exit angles may be configured, for example, in the ranges of 0 to 135 degrees, 0 to 90 degrees, 45 to 90 degrees, or 0 to 45 degrees. Figures 9C–9N depict various alternative configurations of the first and second lumens, including different sizes, shapes, orientations, and positions. [Table 1-1] [Table 1-2]

[0169] Although not depicted in Figures 9C-9N, as described elsewhere, the outer sheath of the imaging device that rapidly rotates inside the guide needle and / or outer sheath may have a shape and size that is partially or completely complementary to the lumen in which it exists.

[0170] In some other exemplary imaging system embodiments, the nose cone of the imaging device may further be configured to reduce the amount of catheter structure that may be within the field of view of the imaging component with respect to visualizing the guidewire and / or guide needle as it exits the catheter exit port of the second catheter lumen. In Figure 10A, for example, the imaging device 1000 comprises a nose cone 1002 with a distal tapered end 1004, and a first catheter lumen 1006 extending therein. The first catheter lumen 1006 may terminate at the distal tapered end 1004 at a distal opening 1008. The nose cone 1002 may be tapered along its overall longitudinal length, or it may comprise a distal tapered region 1004 and a proximal body 1010 with a constant cross-sectional shape and / or size. Proximal to the proximal body 1010 of the nose cone 1002 is the catheter exit port 1012 of the second catheter lumen 1014. The catheter exit port 1012 may also have a distally tapered outer surface 1016. In contrast to the catheter exit port 118 of the imaging device 100 in Figures 5A-6E, the catheter exit port 1012 has an opening 1018 that is more distally oriented rather than laterally oriented. The opening 1018 may be oriented perpendicular to the longitudinal axis of the imaging device 1000 or the second catheter lumen 1014, or with an orientation at an angle to that longitudinal axis, for example, in the range of about 45–135 degrees, 75–105 degrees, or 60–90 degrees. This allows the guide needle 1020 and / or guidewire 1022 to exit the imaging device laterally relative to the proximal body 1012 of the nose cone 1002. Therefore, the imaging component 110 does not image the guide needle 1020 and / or guidewire 1022 through the catheter exit port 1014, but instead has a field of view 1024 that includes only anatomical parts such as the wall of the proximal body 1010 or the true lumen between the imaging device 110 and the guide needle 1020 and / or guidewire 1022. This nose cone configuration can reduce image distortion introduced by additional nose cone structures or materials compared to the embodiments shown in Figures 5A-6E.

[0171] In another modification depicted in Figures 10A and 10B, the nose cone 1032 includes an additional longitudinal or monorail lumen 1034 to allow the guidewire 1022 to exit from the most distal end 1036 of the nose cone 1032. This allows the guidewire 1022 to guide the imaging system or CTO re-entry device 1030 to the target location without interference from the imaging device or suboptimal angle. As depicted in Figure 10B, the monorail lumen 1034 may be in fluid communication with the second catheter lumen 1038 of the catheter body 1040. In certain configurations, the monorail lumen 1034 is longitudinally aligned along the ventral peripheral region of the second catheter lumen 1038. The monorail lumen 1034 may be oriented parallel to at least a portion of the first catheter lumen 1040 containing the imaging device 1042.

[0172] As shown in Figure 10B, the guidewire 1022 is inserted into the monorail lumen 1034, and the guide needle 1044 is withdrawn into the second catheter lumen 1038 so that it can extend outward from the distal end 1036 of the nose cone 1032, and is optionally rotated or oriented (for example, the bent portion or beveled surface 1042 of the guide needle is angled ventrally or toward the imaging device 1042). Once the deployment of the guide needle 1044 reaches the desired location, the guidewire 1022 is withdrawn so that it returns into the guide needle 1044, and then the guide needle 1044 is redeployed through the catheter exit port 1048. This is done using the imaging device 1042, which maintains a continuous view of the guide needle 1040. Once the desired position of the guide needle 1044, for example, the true lumen of a tubular blood vessel, is achieved, the guidewire 1022 is advanced again through the guide needle 1044 and toward the desired position, as depicted in Figure 10C.

[0173] Atherosclerotic plaque removal systems and balloon-based devices

[0174] Figure 11 illustrates an embodiment of a plaque removal system 1102, comprising an embodiment of a plaque removal device 1100 for removing atherosclerotic material from within blood vessels. The plaque removal system 1102 may comprise the plaque removal device 1100, which is coupled to the distal end of a plaque removal catheter 1104. The plaque removal catheter 1104 may be coupled to a handle 1106, which comprises a motor and drive assembly within the handle 1106. The motor and drive assembly can provide torque to a rotatable cutter 1200 (see, for example, Figure 12) of the plaque removal device 1100. The rotatable cutter 1200 may be coupled to the motor and drive assembly via a drive shaft (e.g., a flexible hollow shaft). The drive shaft may extend through the plaque removal catheter 1104 and may be supported by a clamp or bushing to minimize shaft vibration. The rotatable cutter 1200 will be discussed in more detail in the following sections.

[0175] The handle 1106 may also include a battery configured to power the atherosclerotic device 1100 or a motor and one or more sensors within the handle 1106. In other embodiments, the handle 1106 may also include a torque knob or dial and a drive control pusher element.

[0176] The atherosclerotic catheter 1104 may be a long, flexible tube configured to allow a guidewire, drive shaft, control wire, sensor wire, sensor fiber, imaging fiber or wire, or a lumen covering such components, to pass through the catheter lumen. The atherosclerotic catheter 1104 may also be used to deliver or otherwise introduce fluids, pharmaceutical compositions, contrast agents, or combinations thereof to the atherosclerotic device 1100, a targeted therapeutic site in the patient, or a combination thereof.

[0177] In some embodiments, such fluids, pharmaceutical compositions, and / or contrast agents can be introduced through the fluid entry port 1108 of the Y-fitting or Y-connector 1110. In other embodiments, such fluids, pharmaceutical compositions, and / or contrast agents can be introduced through other connections or ports along the atherosclerotic catheter 1104.

[0178] The atherosclerotic catheter 1104 can be partially made from flexible biocompatible polymers such as nylon, silicone rubber, polyurethane, polyethylene terephthalate (PET), latex, thermoplastic elastomer, or combinations thereof.

[0179] Figure 11 also illustrates that the atherosclerotic plaque resection device 1100 may comprise a substantially tubular housing 1112 coupled to or extending from the distal end of the atherosclerotic plaque resection catheter 1104. The atherosclerotic plaque resection device 1100 may further comprise a collection chamber 114 coupled to the distal end of the tubular housing 1112. The collection chamber 1114 may be configured to collect the atherosclerotic material reduced by the rotatable cutter 1200. In some embodiments, the collection chamber 1114 may be a nose cone coupled to the distal end of the tubular housing 1112. The tubular housing 1112 may be fabricated in part from a substantially rigid material. For example, the tubular housing 1112 may be fabricated in part from a biocompatible metallic material, a polymeric material, or a combination thereof. In some embodiments, the tubular housing 1112 or its components can be made from stainless steel, polycarbonate (PC), polyetherketone (PEEK), polyethersulfone (PES), polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC), polyvinylidene fluoride (PVDF), perfluoroalkoxyalkane (PFA), or a combination thereof. In some modifications, materials containing optically transparent polymers with a refractive index of less than 1.60 may be used. Such materials include polyethylene terephthalate (PET), polyamides such as nylon, polydimethylsiloxane (PDMS), fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), and PFA. In some further embodiments, optically transparent polymers with a refractive index of less than 1.45, including ETFE, PDMS, PTFE, FEP, and PFA, may be used. In other embodiments, optically transparent polymers with a refractive index of less than 1.40 may be used, such as PTFE, FEP, and PFA.

[0180] The collection chamber 1114 may be configured to have a tapered or substantially conical shape to ensure that the collection chamber 1114 can be translated or transferred through the patient's blood vessels without causing trauma. The collection chamber 1114 or nose cone may be made from a material that is relatively softer or more deformable than the tubular housing 1112 to allow the collection chamber 1114 or nose cone to bend or flex. In some embodiments, the collection chamber 1114 may be made in part from nylon, silicone rubber, polyurethane, polyethylene terephthalate (PET), latex, thermoplastic elastomer, or a combination thereof.

[0181] As depicted in Figure 1, the tubular housing 1112 may also be provided with a cutting window 116 defined along a portion of the tubular housing 1112. For example, the tubular housing 1112 may be oriented by a dorsal side 1118 and a ventral side 1120 opposite to the dorsal side 1118 (e.g., opposite in the circumferential direction). The cutting window 1116 may be defined along a portion of the dorsal side 1118 of the tubular housing 1112.

[0182] The atherosclerotic plaque resection device 1100 may also include an inflatable balloon 1122 that is partially coupled to the outside of the tubular housing 1112. For example, when the cutting window 1116 is positioned along a portion of the dorsal side 1118 of the tubular housing 1112, the inflatable balloon 1122 can be coupled to the ventral side 1120 of the tubular housing 1112.

[0183] The balloon 1122 can be made in part from polyamide (e.g., nylon or nylon elastomer), polyamide block copolymer, polyethylene terephthalate, polyurethane, polyolefin, polyolefin copolymer, or a compound thereof.

[0184] As will be discussed in more detail in the following sections, when the atherosclerotic plaque resection device 1100 is deployed into the patient's blood vessel, inflating the balloon 1122 can push or bias the cutting window 1116 to be closer to or in contact with the atherosclerotic material in the blood vessel. In this way, the atherosclerotic material (e.g., calcified plaque) can extend at least partially into the cutting window 1116 and be cut or otherwise reduced by the rotatable cutter. In addition, bending or flexing the collection chamber 1114 or nose cone can also assist in pushing or biasing the cutting window 1116 to be closer to or in contact with the atherosclerotic material.

[0185] Figure 12 illustrates a close-up view of the rotatable cutter 1200 of the atherosclerotic device 1100 during operation within the lumen of a blood vessel 1202. As shown in Figure 12, the blood vessel 1202 may be obstructed by atherosclerotic material 1204 deposited along the vessel wall. The balloon 1122 of the atherosclerotic device 1100 can be inflated so that the cutting window 1116 is pushed or biased to be closer to or in contact with the atherosclerotic material 1204. The rotatable cutter 1200, at least in part housed within a tubular housing 1112, can be configured to cut, crush, or otherwise reduce the atherosclerotic material 1204 extending into the cutting window 1116.

[0186] The rotatable cutter 1200 can be coupled to a drive shaft that extends through the catheter lumen and the inside of the tubular housing 1112. A motor (e.g., a turbine motor) in the handle 1106 can rotate the cutter 1200. The rotatable cutter 1200 can also be configured to move longitudinally within the tubular housing 1112 to cut or crush atherosclerotic material 1204 extending into the cutting window 1116.

[0187] The rotatable cutter 1200 may be equipped with multiple rotating blades. For example, the rotatable cutter 1200 may be equipped with four, five, six, seven, eight, or nine or more rotating blades. The rotating blades may be made in part from a rigid, radiopaque material. For example, the rotatable cutter 1200 including rotating blades may be made in part from a biocompatible metal alloy. In a more specific embodiment, the rotatable cutter 1200 including rotating blades may be made in part from tungsten, tantalum, gold, platinum, palladium, iridium, carbide, or a combination thereof. The rotatable cutter 1200 including multiple rotating blades may also be coated or surface-treated with a biocompatible antimicrobial coating such as chromium coating (e.g., ME-92®).

[0188] The rotating blade may have a straight edge, an angled edge, or a combination thereof to prevent damage to the underlying artery wall. The rotatable cutter 1200 can rotate at a rate of approximately 2,000 revolutions per minute (rpm) to approximately 10,000 rpm. For example, the rotatable cutter 1200 can rotate at a rate of approximately 8,000 rpm.

[0189] The rotatable cutter 1200 may have a diameter of approximately 0.50 mm to 1.50 mm. In some embodiments, a portion of the rotatable cutter 1200 may extend beyond the cutting window 1116 of the tubular housing 1112 (for example, by only about 0.01 mm to about 0.50 mm) to allow the rotatable cutter 1200 to cut the atherosclerotic material 1204 that is close to the cutting window 1116.

[0190] In some embodiments, the tubular housing 1112 may have a housing length of about 2.5 mm to about 10.0 mm. In these and other embodiments, the cutting window 1116 may have a window length of about 1.0 mm to about 6.0 mm.

[0191] As shown in the exemplary embodiment depicted in Figure 12, the rotatable cutter 1200 can be longitudinally translated from the proximal end of the tubular housing 1112 toward the distal end of the tubular housing 1112 toward the collection chamber 1114 coupled to the distal end of the tubular housing 1112. Thus, the atherosclerotic device 1100 can be considered an anterior-cutting oriented atherosclerotic device. In other embodiments envisioned by this disclosure, not shown in the figures, the rotatable cutter 1200 can be longitudinally translated from the distal end of the tubular housing to the proximal end of the tubular housing 1112. In these embodiments, the collection chamber 1114 or another collection chamber can be positioned proximal to the tubular housing 1112.

[0192] Figures 13A, 13B, and 13C illustrate a normal blood vessel, a blood vessel occluded by concentric plaque, and a blood vessel occluded by eccentric plaque, respectively. The atherosclerotic devices 1100 and methods disclosed herein can be effectively used to reduce arteries occluded by concentric plaque, eccentric plaque, or a combination thereof.

[0193] Furthermore, the atherosclerotic plaque resection device 1100 and method disclosed herein can be used to reduce the volume of blood vessels having a diameter of approximately 1.5 mm to approximately 7.0 mm. In addition, the atherosclerotic plaque resection device 1100 and method disclosed herein can be used to reduce the volume of atherosclerotic material accumulated in peripheral arteries and coronary arteries. Furthermore, the atherosclerotic plaque resection device 1100 and method disclosed herein can be used to resect plaque associated with the treatment of femoropopliteal artery disease or subpopliteal artery disease of small vessels.

[0194] Figure 14A illustrates an embodiment of the atherosclerotic device 1100 with a balloon 1122 of the device in a non-inflatable configuration 1400. Methods of using the atherosclerotic device 1100 may involve introducing the tubular housing 1112 of the atherosclerotic device 1100 into an occluded vessel 1202 adjacent to a target vessel site 1402. The tubular housing 1112 may comprise a housing lumen 1502 (see, for example, Figures 15A-15E and 16A-16B) that is in fluid communication with the catheter lumen of the atherosclerotic catheter 1104. The balloon 1122 may initially be in the non-inflatable configuration 1400 when the atherosclerotic device 1100 is delivered to the target vessel site 1402 via a delivery catheter / tube or introducer sleeve. Once the atherosclerotic plaque resection device 100 is unloaded or exposed and brought close to the target vessel site 1402, the balloon 1122 is inflated, temporarily occluding the vessel 1202 and pushing or biasing the cutting window 1116 closer to the atherosclerotic material 1204.

[0195] Figure 14B illustrates an embodiment of the atherosclerotic plaque resection device 100 with a balloon 1122 of the device in an inflatable occlusion configuration 1404. The balloon 1122 can be inflated using a fluid 1506 (see, for example, Figures 15A–15E). As will be discussed in more detail in the following sections, the fluid 1506 can be introduced into the balloon lumen 1504 through the housing lumen 1502 of the tubular housing 1112 (see, for example, Figures 15A–15E and 16A–16B). In some embodiments, the balloon lumen 1504 can be in direct fluid communication with the housing lumen 1502. In other embodiments, the balloon lumen 1504 can be in fluid communication with the housing lumen 1502 via a valve 1524 (see, for example, Figures 15B–15E).

[0196] In one embodiment, the balloon 1122 may be configured to inflate as soon as the fluid 506 enters the housing lumen 1502. In another embodiment, the balloon 1122 may be configured to inflate once the fluid pressure in the housing lumen 1502 exceeds a predetermined threshold.

[0197] As shown in Figure 14B, the balloon 1122 and tubular housing 1112 can substantially restrict fluid flow through the blood vessel 1202 when the balloon 1122 is inflated. Obstructing the blood vessel 1202 is necessary for proper imaging of the target blood vessel site 1402, as will be discussed in more detail in the following sections. Once the blood vessel 1202 is temporarily occluded, the blood in the imaging field must be cleared by flushing away or otherwise displacing the blood using an optically transparent medium or fluid. As will be discussed in more detail in the following sections, the same fluid 1506 used to inflate the balloon 1122 can be used to clear the field by flushing away or otherwise displacing the blood in the vicinity of the target blood vessel site 1402. Imaging of the target blood vessel site 1402 (e.g., using OCT) can then be performed after the optically transparent medium or fluid 1506 has flushed away or otherwise displaced the blood.

[0198] Once the rotatable cutter 1200 has reduced or crushed at least a portion of the atherosclerotic material 1204 at the target vessel site 1402, the balloon 1122 can be deflated, and the atherosclerotic device 1100 can be delivered to another target vessel site 1402. When the atherosclerotic device 1100 is used to treat concentric plaque, deflation of the balloon is also necessary to rotate the tubular housing 1112 along its longitudinal axis, positioning the cutting window 1116 in close proximity to additional plaque accumulated around the circumference of the previously treated target vessel site 1402.

[0199] Figure 15A shows a cross-sectional side view of an embodiment of the atherosclerotic plaque resection device 1100, which includes a housing port opening 1500 defined along the dorsal side 1118 of the atherosclerotic plaque resection device 1100. The housing port opening 5100 can be in fluid communication with the housing lumen 1502 of the tubular housing 1112. The housing lumen 1502 of the tubular housing 1112 can be in fluid communication with the catheter lumen of the atherosclerotic plaque resection catheter 1104, the balloon lumen 1504 of the inflatable balloon 1122, and the internal space within the collection chamber 1114. The fluid 1506 introduced into the atherosclerotic catheter 1104 (for example, through the fluid entry port 1108) can fill, or at least partially fill, the housing lumen 1502 and perfuse out of the tubular housing 1112 through the housing port opening 1500 into the target vascular site 1402 surrounding the atherosclerotic device 1100. The fluid 1506 can also exit the tubular housing 1112 through the cutting window 1116.

[0200] The fluid 1506 introduced into the atherosclerotic catheter 1104 and into the housing lumen 1502 can also inflate the balloon 1122. As will be discussed in more detail in the following sections, the fluid 1506 can also exit the balloon lumen 1504 through one or more balloon exit ports 1526 (see Figures 15C, 15D, or 15E) or drainage holes 1700 (see Figure 17).

[0201] As discussed above, inflating the balloon 1122 can be done to temporarily occlude the patient's blood vessel 1202. Once the blood vessel 1202 is temporarily occluded, the blood in the imaging field or field of view 1508 must be cleared by flushing away or otherwise displacing the blood using the (optically transparent) fluid 1506.

[0202] In one exemplary embodiment shown in Figures 15A–15E and 16A–16B, the imaging modality may be optical coherence tomography (OCT). OCT is an infrared-based imaging modality that can be used to generate cross-sectional images of vascular walls and / or deposited plaque with sufficient resolution and contrast to enable a clinician or surgeon to identify features associated with the plaque. For example, such features may include fibrous plaque, lipid-rich plaque, calcium deposits, macrophages, cholesterol crystals, red / white thrombi, or a combination thereof.

[0203] A major challenge encountered when performing intravascular OCT is the high light-scattering properties of blood, which causes significant attenuation of the OCT imaging signal and hinders clear imaging of the vessel wall. To overcome this challenge, blood within the imaging field of view 1508 must first be cleared using an optically transparent fluid or medium.

[0204] As shown in Figures 15A-15E, the same fluid 1506 used to clear the field of view 1508 can also be used to inflate the balloon 1122. For example, as depicted in Figure 15A, the balloon lumen 1504 can be in fluid communication with the housing lumen 1502 via the balloon inlet port 1510 or opening. The balloon inlet port 1510 can be sized or configured to allow the fluid 1506 to enter the balloon lumen 1504 at a controlled fluid flow rate. For example, the opening of the balloon inlet port 1510 can be sized or configured to allow the fluid 1506 to flow out into the balloon lumen 1504. In a more specific embodiment, the balloon inlet port 1510 can have a port diameter of about 100 μm to about 2.0 mm.

[0205] As will be discussed in more detail in the following sections, the balloon inlet port 1510 may have a valve 1524 (see, for example, Figures 15B-15E) positioned between the balloon lumen 1504 and the housing lumen 1502, or otherwise located. In other embodiments, the portion of the balloon 1122 or tubular housing 1112 surrounding the balloon inlet port 1510 may be made of a reinforced, shape-memory material, or a deformable or stretchable material, so that the balloon inlet port 1510 opens only when the fluid pressure exceeds a threshold pressure. In further embodiments, the balloon inlet port 1510 may automatically close once the expansion pressure in the balloon 1122 reaches a predetermined threshold pressure, preventing additional fluid 1506 from entering the balloon lumen 1504.

[0206] As discussed above, the tubular housing 1112 may comprise a dorsal side 1118 and a ventral side 1120 opposite the dorsal side 1118. In the embodiments shown in Figures 15A and 15B, the multiple port openings 1500 may be defined along the dorsal side 1118 of the tubular housing 1112. In other embodiments envisioned by this disclosure, the multiple port openings 1500 may be defined along the ventral side 1120, one or more lateral sides of the tubular housing 1112 between the dorsal side 1118 and the ventral side 1120, or a combination thereof. As shown in Figures 15A, 15B, and 15E, the multiple port openings 1500 may allow the fluid 1506 to be distributed more uniformly within the blood vessels 1202, flushing and removing or otherwise displacing blood within the imaging field of view 1508. The multiple port openings 1500 may also help regulate the pressure within the tubular housing 1112.

[0207] The tubular housing 1112 may also include a rotatable cutter 1200 configured to reduce the amount of atherosclerotic material 1204 extending into or near the cutting window 1116. The rotatable cutter 1200 may be coupled to a drive shaft 1512 connected to a motor and drive assembly in a handle 1106 (see Figure 11). At least a portion of the drive shaft 1512 and the rotatable cutter 1200 may be housed within the cutting assembly catheter lumen 1514 of the cutting assembly catheter 1516. The cutting assembly catheter 1516 can prevent the rotating drive shaft 1512 from becoming entangled with other components within the tubular housing 1112. The cutting assembly catheter lumen 1514 may be a separate lumen from the housing lumen 1502 such that the fluid 1506 introduced into the housing lumen 1502 does not fill, or substantially fill, the cutting assembly catheter lumen 1514.

[0208] Figures 15A-15E also illustrate that the tubular housing 1112 may comprise an imaging catheter 1518 and an optical fiber wire 1520 extending through the imaging catheter lumen 1522. The imaging catheter 1518 may be configured to protect the optical fiber wire 1520 from other components within the tubular housing 1112 and to allow the optical fiber wire 1520 to rotate relative to its longitudinal axis. In addition, the imaging catheter lumen 1522 may be a separate lumen from the housing lumen 1502 such that when the fluid 1506 is introduced into the housing lumen 1502, the fluid 1506 does not fill, or substantially fill, the imaging catheter lumen 1522. Imaging of the target vascular site 1402 or atherosclerotic material 1204 may be performed after flushing the target vascular site 1402 with an optically clear fluid 1506. In addition, imaging of the target vessel site 1402 or the atherosclerotic material 1204 can be performed simultaneously with or at the same time as the flushing. Furthermore, inflation of the balloon 1122 using the fluid 1506 can be performed before, simultaneously with, or at the same time as imaging the target vessel site 1402.

[0209] In some embodiments, fluid 1506 may be a physiological saline solution. For example, fluid 506 may be a 0.90% sodium chloride (NaCl) solution. Alternatively, fluid 1506 may be a 0.45% NaCl solution or a solution containing about 0.45% to about 0.90% NaCl.

[0210] In other embodiments, the fluid 1506 may be a heparinized saline solution or a saline solution containing the anticoagulant heparin. The heparinized saline solution may be used to prevent coagulation or to prevent occlusion from forming at the target vascular site 1402 or within the blood vessel 1202.

[0211] In further embodiments, fluid 1506 is or may contain Ringer's lactate solution (also known as RL or LR solution). Ringer's lactate solution may contain a mixture of sodium chloride, sodium lactate, potassium chloride, and calcium chloride in water. In additional embodiments, fluid 1506 may contain a contrast agent or dye. For example, fluid 1506 is or may contain 30% or 60% iodixanol in Ringer's lactate solution or another type of saline solution (e.g., 0.90% NaCl solution). Furthermore, fluid 1506 is or may contain 30% iohexol in Ringer's lactate solution or another type of saline solution (e.g., 0.90% NaCl solution). In other embodiments, fluid 1506 is or may contain 5% dextran in Ringer's lactate solution or another type of saline solution (e.g., 0.90% NaCl solution).

[0212] Figure 15B illustrates a cross-sectional side view of another embodiment of the atherosclerotic cyst resection device 1100, which includes a valve 1524 configured to control fluid flow into the balloon 1122 of the atherosclerotic cyst resection device 1100. The valve 1524 may be located at the balloon inlet port 1510. The valve 1524 may be coupled to at least one surface of the balloon 1122 and the tubular housing 1112.

[0213] In some embodiments, the valve 1524 may be a one-way valve configured to allow the fluid 1506 to flow only into the balloon lumen 1504. For example, the valve 1524 may be a one-way check valve, a one-way disc valve, a one-way micropump, a one-way umbrella check valve, a one-way ball and cage valve, a one-way inclined disc valve, a one-way bilobed valve, or a one-way trilobed valve.

[0214] In other embodiments, valve 1524 may be a bidirectional valve configured to allow fluid 1506 to flow in and out of the balloon lumen 1504. For example, valve 1524 may be a bidirectional check valve, a bidirectional micropump, or a bidirectional butterfly valve. In further embodiments, valve 1524 may be a pressure-sensitive rupture disc that can rupture when the fluid pressure applied to valve 1524 exceeds a threshold pressure. Valve 1524 may be configured to optimize the rate of fluid flow in and out of the balloon lumen 1504 and to control the expansion and / or contraction of the balloon 1122. For example, valve 1524 may allow fluid 1506 to flow into the balloon lumen 1504 to expand the balloon 1122 until the fluid pressure in the balloon lumen 1504 reaches a threshold pressure level. At that point, valve 1524 may be configured to release fluid 506 out of the balloon lumen 1504 and return it to the housing lumen 1502.

[0215] Figures 15C-15D illustrate cross-sectional side views of an additional embodiment of the atherosclerotic device 1100, comprising an inflatable balloon 1122 having one or more openings or balloon outflow ports 1526 defined along the surface of the balloon 1122. As shown in Figures 15C and 15D, the balloon 1122 may have one balloon outflow port 1526 defined along the surface of the balloon 1122 or two or more balloon outflow ports 1526 defined along the surface of the balloon 1122. When the balloon 1122 has one balloon outflow port 1526, the port 1526 may be located at the distal end of the balloon 1122, at the proximal end of the balloon 1122, or along a surface compartment between the distal and proximal ends (for example, along the ventral or inferior side of the balloon 1122). When the balloon 1122 has multiple balloon outlet ports 1526, the ports 1526 can be spaced apart from each other longitudinally or laterally. In other embodiments, the multiple balloon outlet ports 1526 can be spaced apart longitudinally (for example, one port 1526 at the front of the balloon 1122 and one port 1526 at the rear), laterally (for example, one port 1526 on one side of the balloon 1122 and the other port 1526 on the other side), or a combination thereof. In a more specific embodiment, each balloon outlet port 526 can have a port diameter of about 100 μm to about 2.0 mm.

[0216] As shown in Figure 15D, at least one of the balloon outlet ports 1526 may have a valve 1528 positioned in the balloon outlet port 1526 to control the fluid flow out of the balloon lumen 1504. For example, the valve 1528 may be a one-way valve such as a one-way check valve or a one-way disc valve. The valve 1528 may allow the fluid 1506 to exit or leak out of the balloon 1122 when the fluid pressure inside the balloon 1122 exceeds a predetermined threshold amount (e.g., 4 ATM, 5 ATM, etc.). The valve 1528 and the balloon outlet ports 1526 can prevent accidental rupture of the balloon 1122 or prevent an overinflated balloon 1122 from damaging the blood vessel wall. In addition, the balloon outflow port 1526 may be configured to deliver fluid 1506 into the patient's vascular lumen to temporarily flush or displace blood out of the blood vessel, so that the optical fiber wire 1520 within the atherosclerotic plaque resection device 1100 can more effectively image the blood vessel or the atherosclerotic material 1204 deposited within the blood vessel.

[0217] Figure 15E illustrates a cross-sectional side view of another embodiment of the atherosclerotic device 1100, comprising a housing port opening 1500 defined along the dorsal side 1118 of a tubular housing 1112 and a plurality of openings or balloon outflow ports 1526 defined along the surface of a balloon 1122. As shown in Figure 15E, the atherosclerotic device 1100 may also comprise a valve 1524 located at a balloon inflow port 1510 and a valve 1528 located at one of the balloon outflow ports 1526. Figures 15D and 15E show a valve 1528 located at a balloon outflow port 1526, but it is assumed by this disclosure that the balloon outflow port 1526 may also be left open or sized to allow only fluid 1506 introduced into the balloon lumen 1504 to slowly leak or seep out of the balloon 1122.

[0218] Figure 16A illustrates longitudinal and transverse cross-sectional views of an embodiment of atherosclerotic plaque resection device 1100, which comprises a housing lumen 1502 having a cutting assembly catheter lumen 1514 and an imaging catheter lumen 1522 extending through the housing lumen 1502. The imaging catheter lumen 1522 protects the optical fiber wire 1520 from other components within the housing lumen 1502, preventing the optical fiber wire 1520 from becoming entangled with other wires (e.g., guidewires) or tubes extending through the housing lumen 1502. The cutting assembly catheter lumen 1514 also protects the drive shaft 1512 from other components within the housing lumen 1502, preventing the drive shaft 1512 from becoming entangled with wires (e.g., guidewires) or tubes extending through the housing lumen. As shown in Figure 16A, the balloon lumen 1504 can be in fluid communication with the housing lumen 1502 such that the fluid 1506 entering the housing lumen 1502 also enters the balloon lumen 1504 and inflates the balloon 1122.

[0219] Figure 16B illustrates longitudinal and transverse cross-sectional views of another embodiment of the atherosclerotic device 1100, which comprises a housing lumen 1502 having only an imaging catheter lumen 1522 extending through the housing lumen 1502. The imaging catheter lumen 1522 protects the optical fiber wire 1520 from other components within the housing lumen 1502 and prevents the optical fiber wire 1520 from becoming entangled with other wires (e.g., guide wires) or tubes extending through the housing lumen 1502. In this embodiment, the drive shaft 1512 coupled to the rotatable cutter 1200 can be housed within the housing lumen 1502.

[0220] Figure 17 illustrates a plaque resection device 1100, which includes another embodiment of an inflatable balloon 1122 having a micro-sized drain hole 1700. The drain hole 1700 can allow fluid 1506 to seep out of the balloon lumen 1504 once the balloon 1122 is inflated to a predetermined size or the internal expansion fluid pressure exceeds a certain threshold. For example, the drain hole 1700 can allow fluid 1506 to seep out of the balloon lumen 1504 once the internal expansion fluid pressure reaches 4 ATM. In other embodiments, the drain hole 1700 can allow fluid 1506 to seep out of the balloon lumen 1504 once the internal expansion fluid pressure reaches 5 ATM or 6 ATM.

[0221] Multiple drainage holes 1700 can cover a portion of the balloon 1122, such as the underside or ventral side. In other embodiments, multiple drainage holes 1700 can cover one or both lateral sides of the balloon 1122. In some embodiments, the balloon 1122 may have about 25 to 50 drainage holes 1700. In other embodiments, the balloon 1122 may have about 50 to 100 drainage holes 1700 or more. The drainage holes 1700 can be formed by mechanical puncture, laser cutting, or a combination thereof.

[0222] Each drainage hole 1700 may have a certain diameter. The diameter may be about 1.0 micrometer (μm) to about 10.0 μm (for example, about 5.0 μm). In other embodiments, the diameter may be about 10.0 μm to about 100.0 μm.

[0223] The drainage hole 1700 can allow for more uniform distribution or release of the fluid 1506 into the target vascular site 1402. The drainage hole 1700 can also ensure that the balloon 1122 does not rupture or perforate unintentionally. The drainage hole 1700 may also be a method for controlling the inflation or deflation of the balloon 1122.

[0224] In some embodiments, the balloon 1122 may have drainage holes 1700 of different sizes, positioned or arranged along different parts of the balloon 1122. In other embodiments, the balloon 1122 may comprise multiple layers, each layer having its own set of drainage holes 1700.

[0225] Figures 18A–18D illustrate various embodiments of the inflatable balloon 1122 of the atherosclerotic plaque resection device 1100. For example, Figure 8A illustrates that the inflatable balloon 1122 may have tapered or conical / frustoconical ends on both ends (proximal and distal ends) of the inflatable balloon 1122. The portion of the balloon 1122 between the tapered or conical / frustoconical ends may have a substantially consistent transverse cross-section (for example, formed substantially as a semi-cylindrical or roughly rectangular parallelepiped when inflated).

[0226] Figure 18B illustrates that the inflatable balloon 1122 may have round or bulbous ends at both ends of the inflatable balloon 1122. The portion of the balloon 1122 between the round or bulbous ends may have a substantially consistent transverse cross-section (for example, formed substantially as a semi-cylindrical or roughly rectangular parallelepiped when inflated).

[0227] Figure 18C illustrates that the inflatable balloon 1122 may have a tapered or conical / frustoconical end on one end of the balloon 1122 (e.g., the proximal or distal end) and a round or bulbous end on the other end of the balloon 1122. The portion of the balloon 1122 between the tapered or conical / frustoconical end and the round or bulbous end may have a substantially consistent transverse cross-section (e.g., formed substantially as a semi-cylindrical or roughly rectangular parallelepiped when inflated).

[0228] Figure 18D illustrates that the inflatable balloon 1122 may have a tapered or conical end on one end of the balloon 1122 (e.g., the proximal or distal end) and a round or bulbous end on the other end of the balloon 1122. In this embodiment, the portion of the balloon 1122 between the tapered or conical / frustoconical end and the round or bulbous end can have various lateral cross-sections. For example, the portion of the balloon 1122 between the tapered or conical / frustoconical end and the round or bulbous end can be tapered along the length of the balloon 1122 or can narrow / widen. In other embodiments, the portion of the balloon 1122 between the tapered or conical / frustoconical ends may have a constricted portion in the middle of the balloon 1122.

[0229] An operator or clinician of the atherosclerotic device 1100 may select a version of the device 1100 having one of the balloons 1122 disclosed herein, based on the size of the blood vessel, the extent of occlusion or blockage, the type of occlusion (e.g., concentric or eccentric), or a combination thereof. In addition, any of the balloons 1122 disclosed herein (including any of the balloons 1122 shown in Figures 18A–18D) may include any of the balloon features disclosed herein, including a drain hole 1700 or other type of balloon port or opening, one or more valves located within or on the surface of the balloon 1122, and multiple balloon layers.

[0230] In other embodiments, the inflatable balloon assemblies described herein may also be implemented with any of a variety of diagnostic or therapeutic catheter systems. For example, an imaging device or CTO re-entry device, as described herein, may be adapted with an inflatable balloon. The inflatable balloon may be inflated using a second catheter lumen of the device, or a separate lumen may be provided. In Figures 7C and 7D, for example, an imaging device or CTO re-entry device with a guide needle from Figures 7A and 7B may be further adapted with an inflatable balloon. In the specific embodiments depicted in Figures 7C and 7D, the imaging device or CTO re-entry device 750 includes an inflatable balloon on the dorsal side of the device 750. The cavity 754 of the balloon 750 is in fluid communication with a second catheter lumen 106 via one or more perfusion ports 600 for inflation, although in other embodiments, a separate lumen and other ports are used to inflate the balloon. An inflatable balloon may be provided ventrally on the imaging device and inflated through the first catheter lumen 104 via the ventral perfusion port 600. Other balloon features, such as those described in relation to atherosclerotic resection devices, including one or more drainage holes 756, may also be provided with the imaging device or CTO re-entry device.

[0231] Several embodiments have been described. Nevertheless, it will be understood by those skilled in the art that various modifications can be made without departing from the spirit and scope of the embodiments. In addition, the flowcharts or logical flows depicted in the figures do not require any particular order or sequential sequence shown in order to achieve the desired result. Furthermore, other steps or actions may be provided, or steps or actions may be removed from the described flows, and other components may be added to or removed from the described systems. Thus, other embodiments are also within the scope of the following claims.

[0232] Each of the individual modifications or embodiments described and illustrated herein has discrete components and features that can be readily separated from or combined with any of the features of other modifications or embodiments. Modifications may be made to adapt a particular situation, material, composition, process, process act, or step to the object, spirit, or scope of the invention.

[0233] The methods enumerated herein may be performed in any logically possible order of the enumerated events, and in the order in which the events are enumerated. Additional steps or actions may be provided, or steps or actions may be omitted, in order to achieve the desired result.

[0234] Furthermore, if a range of values ​​is provided, all intervening values ​​between the upper and lower limits of that range, and any other described or intervening values ​​within that range, are included within the present invention. Also, any optional feature of the described inventive modification may be described, independently, or in combination with any one or more of the features described herein.

[0235] All existing subject matter referenced herein (e.g., publications, patents, and patent applications) is incorporated herein by reference in whole, except where such subject matter may conflict with that of the present invention (in which case the material present herein shall prevail). The referenced items are provided only with respect to their disclosure prior to the filing date of this application. Nothing herein shall be construed as admitting that the present invention has no prior rights to such material by prior art.

[0236] Reference to a singular item includes the possibility of multiple identical items existing. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said,” and “the” include plural nouns unless the context clearly indicates otherwise. It should be further noted that claims may be drafted to exclude any optional elements. Thus, the language is intended to serve as an antecedent for the use of exclusive technical terms such as “simply,” “only,” and “equivalences,” or for the use of “negative” limitation, relating to the enumeration of claim elements. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art in which the invention pertains.

[0237] This disclosure is not intended to be limited to the specific forms described herein, but rather to encompass alternatives, modifications, and equivalents of the variations or embodiments described herein. Furthermore, the scope of this disclosure fully encompasses other variations or embodiments that may become apparent to those skilled in the art in light of this disclosure.

[0238] Those skilled in the art will understand that the various methods disclosed herein may be embodied in non-transient-readable, machine-readable, and / or machine-accessible media, comprising instructions that are compatible, readable, and / or executable by the processor or server processor of a machine, device, or computing device. The structures and modules in the figures may be shown as distinctly different, communicating with only some specific structures and not others. Structures may be merged with each other, perform overlapping functions, and communicate with other structures not shown to be connected to the figures. Thus, this specification and / or drawings may be considered illustrative rather than restrictive.

Claims

1. An imaging device, an elongate catheter body configured to be advanced through a patient's vasculature, the catheter body having a dorsal side and a ventral side opposite the dorsal side; a first catheter lumen extending through the catheter body, the first catheter lumen configured to house at least a portion of an imaging component; a second catheter lumen extending through the catheter body, the second catheter lumen configured to house at least a portion of a guidewire, the second catheter lumen being separate from the first catheter lumen; one or more windows defined between the first and second catheter lumens, the one or more windows configured to allow light to be transmitted through the one or more windows; a catheter exit port defined along an anterior side of the catheter body and in fluid communication with the second catheter lumen, the catheter exit port configured to allow the guidewire to advance out of the second catheter lumen, the catheter exit port aligned with at least one of the one or more windows such that the guidewire is within a field of view of the imaging component when the guidewire extends partially through the catheter exit port; An apparatus comprising:

2. The device of claim 1 , further comprising an introducer needle slidably positioned within the second catheter lumen, the introducer needle comprising a needle lumen configured to slidably receive a guidewire.

3. The device of claim 2 , wherein the introducer needle comprises a beveled distal end with a beveled surface.

4. The device of claim 3 , wherein the beveled surface is perpendicular to a longitudinal axis of the elongate catheter body.

5. The device of claim 2 , further comprising a needle lock configured to reversibly lock the movement of the OCT imaging to the movement of the introducer needle.

6. The device of claim 1 , wherein longitudinal or axial displacement of the imaging component is correlated with longitudinal or axial displacement of the guidewire.

7. The device of claim 6 , wherein a proximal section of the guidewire is coupled to a proximal portion of the imaging component.

8. 7. The device of claim 6, wherein longitudinal or axial displacement of the imaging component is tracked by one or more encoders positioned along a proximal portion of the imaging component, and longitudinal or axial displacement of the guidewire is tracked by the one or more encoders positioned along a proximal section of the guidewire.

9. The device of claim 1 , wherein the imaging component is configured to be oscillated such that the imaging component rotates back and forth about a longitudinal axis of rotation at a rotation angle of less than 180 degrees.

10. 10. The apparatus of claim 1, wherein the imaging component is configured to be rotated during operation at a constant speed that may be adjustable relative to a longitudinal axis of rotation at less than 2,000 rpm.

11. The apparatus of claim 1 , wherein the imaging component is configured to be rotated during operation at various speeds about a longitudinal axis of rotation at less than 2,000 rpm.

12. 10. The device of claim 1, further comprising an additional catheter exit port defined along the ventral side of the catheter body, the additional catheter exit port configured to allow the guidewire to be advanced out of the second catheter lumen at various locations along the catheter body.

13. 10. The device of claim 1, further comprising one or more windows defined along the ventral side of the catheter body, wherein at least one of the one or more windows defined along the ventral side of the catheter body is aligned with at least one of the one or more windows defined along a split layer such that a section of the guidewire extending out of the catheter exit port and into the vessel is within a field of view of the imaging component through the window.

14. 10. The device of claim 1, wherein the one or more windows are made in part from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene.

15. 10. The device of claim 1, wherein the one or more windows are fabricated in part from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide.

16. 10. The device of claim 1, wherein the one or more windows are made in part from at least one of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET).

17. The apparatus of claim 1 , wherein the imaging component is part of an optical coherence tomography (OCT) imaging system, the OCT imaging system configured to perform image registration on images captured by the imaging component.

18. An imaging device, an elongate catheter body configured to be advanced through a patient's vasculature, the catheter body having a dorsal side and a ventral side opposite the dorsal side; a first catheter lumen extending through the catheter body, the first catheter lumen configured to house at least a portion of an imaging component; a second catheter lumen extending through the catheter body, the second catheter lumen configured to house at least a portion of a guidewire, the second catheter lumen being separate from the first catheter lumen; one or more windows defined between the first and second catheter lumens, the one or more windows configured to allow light to be transmitted through the one or more windows; a catheter exit port in fluid communication with the second catheter lumen, the catheter exit port having an orthogonal orientation to a longitudinal axis of the elongate catheter body and a longitudinal position spaced proximally from a distal end of the first catheter lumen, the catheter port configured to allow the guidewire to advance out of the second catheter lumen, the catheter exit port aligned with at least one of the one or more windows such that the guidewire is within a field of view of the imaging component when the guidewire extends partially through the catheter exit port; An apparatus comprising:

19. 20. The apparatus of claim 18, further comprising an introducer needle slidably positioned within the second catheter lumen, the introducer needle comprising a needle lumen configured to slidably receive a guidewire.

20. 1. A method for tracking a guidewire, comprising: advancing an elongate catheter body through a patient's vasculature, said catheter body comprising: a first catheter lumen extending through the catheter body, the first catheter lumen configured to house at least a portion of an imaging component; a second catheter lumen extending through the catheter body, the second catheter lumen configured to house at least a portion of the guidewire, the second catheter lumen being separated from the first catheter lumen by a dividing layer; and advancing the guidewire segment out a catheter exit port defined along the ventral side of the catheter body; imaging the guidewire using light transmitted from an imaging component extending through the first catheter lumen, the light transmitted through one or more windows defined along the split layer, the catheter exit port being aligned with at least one of the one or more windows such that the guidewire is within a field of view of the imaging component when the guidewire extends partially through the catheter exit port; A method comprising:

21. further comprising advancing an introducer needle from the second catheter port; 21. The method of claim 20, wherein advancing a section of the guidewire out of the catheter exit port comprises advancing a section of the guidewire through a lumen of the introducer needle, out of the catheter exit port, and out of a distal opening of the introducer needle.

22. 22. The method of claim 21, further comprising engaging an introducer lock to tie together movement of the introducer and the imaging component.

23. 23. The method of claim 22, wherein the introducer lock provides a 1:1 movement ratio between the introducer and the imaging component.

24. 23. The method of claim 22, wherein the introducer lock provides a predetermined variable ratio of movement between the introducer and the imaging component.

25. 21. The method of claim 20, further comprising correlating longitudinal or axial displacement of the imaging component with longitudinal or axial displacement of the guidewire.

26. The method of claim 20 , wherein a proximal section of the guidewire is coupled to a proximal portion of the imaging component.

27. 21. The method of claim 20, further comprising tracking longitudinal or axial displacement of the imaging component using one or more encoders positioned along a proximal portion of the imaging component and tracking longitudinal or axial displacement of the guidewire using the one or more encoders positioned along a proximal section of the guidewire.

28. 21. The method of claim 20, further comprising oscillating the imaging component within the catheter body such that the imaging component rotates back and forth about a longitudinal axis of rotation at a rotation angle of less than 180 degrees.

29. 21. The method of claim 20, further comprising rotating the imaging component during operation at a constant speed that may be adjustable relative to a longitudinal axis of rotation at less than 2,000 rpm.

30. 21. The method of claim 20, further comprising rotating the imaging component during operation at varying speeds about a longitudinal axis of rotation at less than 2,000 rpm.

31. 21. The method of claim 20, further comprising advancing the guidewire out of an additional catheter exit port defined along the ventral side of the catheter body, the additional catheter exit port configured to allow the guidewire to be advanced out of the second catheter lumen at another location along the catheter body.

32. 21. The method of claim 20, further comprising one or more windows defined along the ventral side of the catheter body, wherein at least one of the one or more windows defined along the ventral side of the catheter body is aligned with at least one of the one or more windows defined along the split layer such that a section of the guidewire extending out of the catheter exit port and into the vessel is within a field of view of the imaging component through the window.

33. 21. The method of claim 20, wherein the one or more light-transmittable windows are made in part from at least one of polymethyl methacrylate (PMMA), polypropylene, polycarbonate, and polyethylene.

34. 21. The method of claim 20, wherein the one or more windows are made in part from at least one of calcium fluoride, germanium oxide, silicon dioxide, aluminum oxide, and zinc selenide.

35. 21. The method of claim 20, wherein the one or more windows are made in part from at least one of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), ethylene tetrafluoroethylene (ETFE), polydimethylsiloxane (PDMS), nylon, polyether block amide (PEBAX®), and polyethylene terephthalate (PET).

36. 21. The method of claim 20, wherein the imaging component is part of an optical coherence tomography (OCT) imaging system, and the method further includes performing image registration on images captured by the imaging component using the OCT imaging system.

37. 1. An atherectomy device for removing atherosclerotic material in a blood vessel, comprising: a tubular housing coupled to or extending from a distal end of the catheter, said tubular housing comprising: a housing lumen configured to be in fluid communication with a catheter lumen of the catheter; a cutting window defined along a portion of the tubular housing; a rotatable cutter configured to debulk the atherosclerotic material extending into the cutting window; and a tubular housing comprising: a collection chamber coupled to the tubular housing, the collection chamber configured to collect the atherosclerotic material reduced by the rotatable cutter, the collection chamber in fluid communication with the housing lumen; an inflatable balloon coupled to the exterior of the tubular housing, the inflatable balloon comprising a balloon lumen in fluid communication with the housing lumen such that fluid introduced into the housing lumen via the catheter lumen clears a field adjacent the cutting window and inflates the inflatable balloon; A device comprising:

38. 38. The device of claim 37, wherein the tubular housing further comprises a dorsal side and a ventral side opposite the dorsal side, the tubular housing comprising a plurality of housing port openings defined along the dorsal side of the tubular housing.

39. 38. The device of claim 37, wherein the fluid is a saline solution or a contrast agent.

40. 40. The device of claim 39, wherein the saline solution is a heparinized saline solution.

41. 38. The device of claim 37, wherein the tubular housing further comprises an imaging catheter and a fiber optic cable extending at least partially through the imaging catheter, the fiber optic cable configured to image the blood vessels and the atherosclerotic material surrounding the tubular housing via optical coherence tomography (OCT).

42. 38. The device of claim 37, wherein the inflatable balloon further comprises a valve configured to control fluid ingress into the balloon lumen.

43. 43. The device of claim 42, wherein the valve is a one-way valve configured to allow fluid flow only into the balloon lumen.

44. 43. The device of claim 42, wherein the valve is a two-way valve configured to allow fluid flow into and out of the balloon lumen.

45. 38. The device of claim 37, wherein the inflatable balloon further comprises one or more drainage holes configured to allow fluid to seep out of the balloon lumen.

46. 38. The device of claim 37, wherein the rotatable cutter is coupled to a drive shaft extending through the catheter and the tubular housing, the rotatable cutter being longitudinally translatable within the housing lumen via the drive shaft.

47. 38. The device of claim 37, wherein the balloon and tubular housing are configured to substantially restrict fluid flow through the blood vessel when the balloon is inflated.

48. 1. A method for reducing atherosclerotic material in a blood vessel, comprising: introducing a tubular housing of an atherectomy device into the blood vessel and adjacent to the atherosclerotic material, the tubular housing being coupled to or extending from a distal end of a catheter, the tubular housing comprising: a housing lumen configured to be in fluid communication with a catheter lumen of the catheter; a cutting window defined along a portion of the tubular housing; a rotatable cutter; and inflating a balloon coupled to the exterior of the tubular housing using fluid introduced into the housing lumen via the catheter lumen, the balloon lumen of the balloon being in fluid communication with the housing lumen; flushing a field adjacent to the tubular housing with the fluid introduced into the housing lumen; A method comprising:

49. 49. The method of claim 48, further comprising deflating the balloon to rotate the tubular housing of the atherectomy device within the blood vessel.

50. 49. The method of claim 48, further comprising imaging the blood vessels and the atherosclerotic material surrounding the tubular housing through optical coherence tomography (OCT) using an imaging catheter and a fiber optic wire extending at least partially through the imaging catheter.

51. 49. The method of claim 48, wherein flushing the field proximate the tubular housing sweeps a field of view proximate the tubular housing, and wherein the imaging is performed after flushing with the fluid.

52. 49. The method of claim 48, wherein the tubular housing further comprises a dorsal side and a ventral side opposite the dorsal side, the tubular housing comprising a plurality of housing port openings defined along the dorsal side of the tubular housing, and wherein flushing a section of the blood vessel proximate the tubular housing with the fluid further comprises directing the fluid through the plurality of housing port openings.

53. 49. The method of claim 48, wherein the fluid is a saline solution or a contrast agent.

54. 54. The method of claim 53, wherein the saline solution is a heparinized saline solution.

55. 49. The method of claim 48, wherein the balloon further comprises a valve configured to control fluid ingress into the balloon lumen.

56. 56. The method of claim 55, wherein the valve is a one-way valve configured to allow fluid flow only into the balloon lumen.

57. 56. The method of claim 55, wherein the valve is a two-way valve configured to allow fluid flow into and out of the balloon lumen.

58. 49. The method of claim 48, wherein the balloon further comprises one or more drainage holes configured to allow fluid to seep out of the balloon lumen.

59. 49. The method of claim 48, further comprising longitudinally translating the rotatable cutter within the tubular housing by translating a drive shaft coupled to the rotatable cutter, the drive shaft extending through the catheter and the tubular housing.

60. 49. The method of claim 48, further comprising using the rotatable cutter to cut the atherosclerotic material extending into the cutting window.

Images