CATHETER SYSTEM INCLUDING ALIGNMENT ASSEMBLY FOR FIBER OPTIC CONNECTORS IN MEDICAL LASER APPLICATIONS - Patent application

Abstract

A catheter system (100) for treating a vascular lesion (106A) in or adjacent to a vascular wall (108A) within a body (107) of a patient (109). The catheter system (100) includes a light source (124), a receptacle assembly (274), a first light guide (122A) and a second light guide (122A), a multiplexer (128), and an alignment assembly (256). The light source (124) generates a light source beam (124A) of light energy. The first light guide (122A) and the second light guide (122A) are coupled to the receptacle assembly (274), and each light guide (122A) has a guide proximal end (122P). The multiplexer 128 receives the source beam 124A from the light source 124, and the multiplexer 128 directs individual guide beams 124B from the source beam 124A to each of the proximal guide ends 122P of the first light guide 122A and the proximal guide ends 122P of the second light guide 122A. The alignment assembly 256 adjusts the position of the receptacle assembly 274 relative to the individual guide beams 124B.

Description

[Background technology]

[0001] Vascular lesions within the body's blood vessels can be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, etc. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult for physicians to treat and achieve patency in clinical practice.

[0002] Vascular lesions may be treated using procedures such as medical therapy, balloon angioplasty, atherectomy, stent placement, and vascular graft bypass, to name a few, but such procedures may not always be ideal or may require subsequent treatment to address the lesion.

[0003] In modern medicine, lasers are increasingly utilized to treat various medical conditions as interest in minimally invasive treatments grows. The physical properties of lasers allow the same basic principles to be applied to many tissue types using slight modifications of the system. Laser energy can be used safely and effectively for lithotripsy, intravascular lithotripsy, for the treatment of various types of cancer, for many cosmetic and reconstructive procedures, and for the ablation of abnormal conductive pathways. Some applications require access to constricted spaces, so devices with small diameter fibers may be of interest. The high energy required for application may force device designers to find a way to target the laser energy to a small surface area of ​​the fiber while staying below the damage threshold of the optical fiber material (the damage threshold is the highest power / energy density per area that an optical component can withstand without causing damage).

[0004] Optical fiber cores have a much higher damage threshold than the jacket and aligning ferrules that surround the fiber, and therefore if the laser beam energy escapes the core and enters the cladding, the fiber will be damaged, even if the laser beam energy is at a power level such that it can be conducted through the fiber core without damage.

[0005] Since the therapeutic application defines the required energy level, another parameter that the designer can control to reduce density is to increase the incidence area of ​​the laser beam on the face of the fiber, which reduces the power / energy density but reduces the margin between the laser beam incidence area and the fiber core size.

[0006] The commonly used term for ensuring that the beam and fiber are concentric is the alignment of the beam to the fiber. Given the small margins mentioned above, the alignment must be extremely accurate, down to the single micron level.

[0007] Devices that encapsulate multiple fibers (e.g., fiber arrays) and a single laser beam that is diverted to couple to them by mechanisms such as an acousto-optic modulator (AOM) or other multiplexing must fine-tune the alignment of the diverted beam as it will be applied to all fibers in the fiber array. In situations where multiple beams are being directed simultaneously at many fibers, the alignment not only requires that the beam positions align with the fiber positions, but that the lines between the beams and the lines between the targeted fibers overlap each other.

[0008] Traditional alignment methods utilize a laser beam sent through an acousto-optic deflector (AOD) and correct the alignment by adjusting a screw or piezoelectric component that redirects the laser source (or a mirror that reflects the laser source on its path to the AOD), thus affecting the line on the fiber array plane where the AOD directs the beam. Problems with using an AOD for beam deflection include energy loss through the AOD and poor coupling tolerance on the light guide. The incidence angle of the deflected beam (at higher deflection angles) results in an elliptical beam shape, which makes the optical coupling less efficient.

[0009] Medical devices present unique challenges with regard to maintaining accurate alignment. Due to health hazards associated with cross-contamination between patients, in many medical devices it is preferred to design the device such that the parts that come into contact with the patient (application parts) are disposable devices. If the fiber is encapsulated in the application part and the high energy laser is not part of the disposable device, then this alignment must be maintained or re-established each time a new application part device is connected to the laser source. Summary of the Invention

[0010] The present invention is directed to a catheter system for placement within a blood vessel having a vascular wall. The catheter system may be used to treat vascular lesions within or adjacent to a vascular wall within a patient's body. The catheter system includes a light source, a receptacle assembly, a first light guide, a second light guide, a multiplexer, and an alignment assembly. The light source generates a light source beam of light energy. The first light guide and the second light guide are coupled to the receptacle assembly, each light guide having a guide proximal end. The multiplexer receives the light source beam from the light source, and the multiplexer directs individual guide beams from the light source beam to each of the guide proximal end of the first light guide and the guide proximal end of the second light guide. The alignment assembly adjusts the position of the receptacle assembly relative to the individual guide beams.

[0011] In certain embodiments, the proximal guide end of the first light guide and the proximal guide end of the second light guide each have two rotational degrees of freedom.

[0012] In some embodiments, the receptacle assembly has three degrees of freedom.

[0013] In various embodiments, the receptacle assembly has three rotational degrees of freedom.

[0014] In a particular embodiment, the multiplexer has at least one degree of freedom.

[0015] In some embodiments, the alignment assembly adjusts the position of the receptacle assembly relative to the individual guide beams with micrometer level adjustment.

[0016] In various embodiments, the alignment assembly adjusts the position of the receptacle assembly relative to the multiplexer.

[0017] In certain embodiments, the receptacle assembly is coupled to an alignment assembly.

[0018] In some embodiments, the multiplexer is coupled to the alignment assembly.

[0019] In various embodiments, the alignment assembly includes a camera that captures an image of the guide proximal end of each light guide so that the position of the individual guide beams relative to the guide proximal end can be adjusted.

[0020] The present invention is also directed to a catheter system for placement within a blood vessel having a vascular wall. The catheter system may be used to treat vascular lesions within or adjacent to a vascular wall within a patient's body. The catheter system includes a light source, a receptacle assembly, a first light guide and a second light guide, a multiplexer, and an alignment assembly. The light source generates a light source beam of light energy. The first light guide and the second light guide are coupled to the receptacle assembly, each light guide having a guide proximal end. The multiplexer receives the light source beam from the light source, and the multiplexer directs individual guide beams from the light source beam to each of the guide proximal end of the first light guide and the guide proximal end of the second light guide. The alignment assembly adjusts the position of the receptacle assembly relative to the individual guide beams.

[0021] In some embodiments, the alignment assembly adjusts the position of the receptacle assembly relative to the individual guide beams with micrometer level corrections.

[0022] In various embodiments, the alignment assembly adjusts the position of the receptacle assembly relative to the multiplexer.

[0023] In certain embodiments, the receptacle assembly is coupled to an alignment assembly.

[0024] In some embodiments, each of the guide proximal ends is coupled to an alignment assembly such that the guide proximal ends have two rotational degrees of freedom.

[0025] In various embodiments, the receptacle assembly is coupled to the alignment assembly such that the receptacle assembly has three degrees of freedom.

[0026] In a particular embodiment, the receptacle assembly is coupled to the alignment assembly such that the receptacle assembly has three rotational degrees of freedom.

[0027] In some embodiments, the multiplexer is coupled to the alignment assembly such that the multiplexer has at least one degree of freedom.

[0028] In various embodiments, the alignment assembly includes a camera that captures an image of the guide proximal end of each light guide so that the position of the individual guide beams relative to the guide proximal end can be adjusted.

[0029] In certain embodiments, the catheter system further comprises a system controller including a processor configured to control operation of the light source to generate a single light source beam in the form of pulses of light energy that are directed to the multiplexer, the system controller further configured to control operation of the multiplexer such that the first guide beam is directed to the first light guide and the second guide beam is directed to the second light guide.

[0030] In some embodiments, the light source includes a laser.

[0031] In various embodiments, the catheter system further comprises a catheter shaft and a balloon coupled to the catheter shaft, the balloon including a balloon wall defining a balloon interior, the balloon configured to hold a balloon fluid within the balloon interior, and the first light guide and the second light guide are positioned at least partially within the balloon interior.

[0032] In certain embodiments, the balloon is selectively inflatable with a balloon fluid to expand to an inflated state, and when the balloon is in the inflated state, the balloon wall is configured to be positioned substantially adjacent to the vascular lesion.

[0033] In some embodiments, the first light guide and the second light guide receive light energy from the light source and direct the light energy from the light source to the interior of the balloon to generate a plasma in the balloon fluid within the interior of the balloon, the generation of the plasma causing rapid bubble formation and imparting a pressure wave to the balloon wall adjacent the vascular lesion.

[0034] In various embodiments, the multiplexer includes an optical element that splits the source beam into the first guide beam and the second guide beam.

[0035] In certain embodiments, the multiplexer further includes a coupling optic configured to focus the first guide beam onto the first light guide and the second guide beam onto the second light guide.

[0036] In some embodiments, the first guide beam and the second guide beam are incident on the combining optic with an angle between them.

[0037] In various embodiments, the catheter system further comprises a guide bundle that brings the first light guide and the second light guide closer together so that the first light guide and the second light guide are in a more compact form.

[0038] In certain embodiments, the receptacle assembly includes a receptacle assembly housing, a receptacle ferrule receiver, and a receptacle ferrule retainer.

[0039] In some embodiments, the receptacle ferrule retainer selectively locks each of the first light guide and the second light guide in a desired position within the receptacle ferrule receiver.

[0040] In various embodiments, the receptacle ferrule retainer is a plunger ball spring bridge including a plurality of plunger ball springs configured to selectively lock each of the first light guide and the second light guide in a desired position within the receptacle ferrule receiver, respectively.

[0041] In certain embodiments, the alignment assembly includes a first stage selectively secured to the receptacle assembly, the first stage configured to rotate about one of the first axis and the second axis.

[0042] In some embodiments, the alignment assembly further includes a first stage knob that selectively engages the first rotating cam.

[0043] In various embodiments, the first rotating cam is coupled to the first armature.

[0044] In a particular embodiment, the first mover drives a first rotating cam such that the first stage moves in a rotational motion.

[0045] In some embodiments, the alignment assembly includes a second stage selectively secured to the first stage, the second stage configured to raise and lower the first stage on the first axis.

[0046] In various embodiments, the alignment assembly includes a second stage knob that engages the second rotating cam.

[0047] In certain embodiments, the second rotating cam is coupled to the second armature.

[0048] In some embodiments, the second mover drives a second rotating cam such that the second stage raises and lowers the first stage on the first axis.

[0049] The present invention is also directed to a method of aligning a light source in a catheter system for treating a vascular lesion in or adjacent to a vascular wall within a patient's body, the catheter system including a single light source that generates light energy. In various embodiments, the method can include initiating control of a plurality of hardware of the catheter system, the plurality of hardware including at least one of: (i) a light guide configured to selectively receive light energy from the light source, (ii) a camera that captures the alignment of the light source within the light guide, and (iii) a mover configured to selectively adjust the positioning of the light source within the light guide; performing a coarse alignment of the positioning of the light source within the light guide; inspecting at least one of (i) the alignment of the light source within the light guide and (ii) a light energy level of the light source; and performing a fine alignment of the positioning of the light source within the light guide.

[0050] In various embodiments, the method further includes inspecting the alignment of the optical connectors.

[0051] In certain embodiments, the method further includes continuously monitoring the alignment of the light source within the light guide with a camera.

[0052] In some embodiments, the step of performing coarse alignment includes loading hard-coded alignment settings of an alignment algorithm configured to autonomously align the light source with the light guide.

[0053] In various embodiments, the step of performing a coarse alignment includes loading a number of light guide reference positions and coordinates from an alignment algorithm.

[0054] In certain embodiments, the step of performing coarse alignment includes initializing at least one of (i) a camera, (ii) an illumination source configured to illuminate an end face of the light guide, and (iii) a stage coupled to the light guide, the stage configured to adjust a positioning of the light guide relative to the light source.

[0055] In some embodiments, the step of performing a coarse alignment includes moving the stage to a second stage position.

[0056] In various embodiments, the step of performing coarse alignment includes capturing a plurality of captured images with the camera while the stage is at the second stage position.

[0057] In certain embodiments, the step of performing coarse registration includes determining whether multiple reference targets are included in the multiple captured images.

[0058] In some embodiments, when multiple reference targets are included in the multiple captured images, the step of performing coarse alignment includes detecting multiple light guide reference positions and coordinates using an alignment algorithm configured to autonomously align the light source with the light guide.

[0059] In various embodiments, if the multiple reference targets are not included in the multiple captured images, the step of performing coarse alignment includes moving the stage to a second stage position and capturing multiple second captured images using the camera while the stage is in the second stage position.

[0060] In certain embodiments, the step of performing a coarse registration includes checking the catheter system for systematic errors.

[0061] In some embodiments, if the catheter system has one or more system errors, the catheter system is updated and error handling is initiated.

[0062] In various embodiments, if the catheter system does not have one or more systematic errors, the step of performing a coarse alignment includes calculating a first tolerance region for a plurality of light guide reference positions and coordinates.

[0063] In certain embodiments, the step of performing a coarse alignment includes verifying that alignment of the light source within the light guide is within a first tolerance region for a plurality of light guide reference positions and coordinates.

[0064] In some embodiments, the step of performing a coarse alignment is complete when the alignment of the light source within the light guide is within a first tolerance region for a plurality of light guide reference positions and coordinates.

[0065] In various embodiments, if the alignment of the light source within the light guide is not within a first tolerance region for a plurality of light guide reference positions and coordinates, the step of performing a coarse alignment includes verifying a plurality of alignment data.

[0066] In certain embodiments, if the verification of the multiple registration data results in a verification error, the catheter system is updated and error handling is initiated.

[0067] In some embodiments, if verification of the multiple alignment data does not result in a verification error, the step of performing coarse alignment further includes removing the multiple camera offsets and performing a linear regression on the multiple hardware offsets.

[0068] In various embodiments, the hardware offsets include at least one of a tilt offset, a y-axis offset, and an x-axis offset.

[0069] In a particular embodiment, the step of performing the coarse alignment further includes positioning the hardware based on the hardware offsets.

[0070] In some embodiments, the step of performing the coarse alignment further includes moving the stage to a third stage position and capturing a plurality of third captured images using the camera while the stage is at the third stage position.

[0071] The present invention is further directed to a catheter system for treating vascular lesions in or adjacent to a blood vessel wall within a patient's body. In certain embodiments, the catheter system includes a light source generating a source beam of light energy, a receptacle assembly, a first light guide and a second light guide coupled to the receptacle assembly, each light guide having a guide proximal end, a multiplexer receiving the source beam from the light source, the multiplexer directing individual guide beams from the source beam to each of the guide proximal end of the first light guide and the guide proximal end of the second light guide, and an alignment assembly adjusting a position of the receptacle assembly relative to the individual guide beams, the alignment assembly including a first mover that moves the receptacle assembly.

[0072] In various embodiments, the first mover includes at least one of a motor and an actuator.

[0073] In certain embodiments, the first mover includes a rack-and-pinion motor.

[0074] In some embodiments, the alignment assembly further includes a plurality of rollers coupled to the first mover, the plurality of rollers configured to roll the first stage about the first axis.

[0075] In various embodiments, the alignment assembly includes a mechanical flexure that cooperates with the first mover to generate the angular displacement.

[0076] In certain embodiments, the alignment assembly includes a mechanical flexure that cooperates with the first mover to generate the linear displacement.

[0077] In some embodiments, the first mover includes a screw mechanism and a motor.

[0078] In various embodiments, the first mover includes one of a piezoelectric stack and an actuator.

[0079] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part hereof, each of which should not be taken in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0080] The novel features of the present invention, as well as the invention itself, both as to its structure and its operation, will best be understood from the accompanying drawings taken in conjunction with the accompanying description, in which like reference characters refer to like parts, and in which: [Brief description of the drawings]

[0081] [Figure 1] FIG. 1 is a schematic cross-sectional view of one embodiment of a catheter system according to various embodiments herein, the catheter system including multiple light guides, a multiplexer, and a guide bundle. [Diagram 2] FIG. 1 is a partially exploded perspective view of a portion of an embodiment of a catheter system, including an alignment assembly and a receptacle assembly. [Diagram 3]FIG. 13 is a front view of a portion of an embodiment of a catheter system including another embodiment of an alignment assembly and a receptacle assembly. [Figure 4] FIG. 1 is a perspective view of a portion of an embodiment of a catheter system including an embodiment of a guide bundle. [Diagram 5] FIG. 1 is a perspective view of a portion of an embodiment of a catheter system including an embodiment of a receptacle assembly. [Figure 6] FIG. 13 is a perspective view of a portion of an embodiment of a catheter system including yet another embodiment of an alignment assembly, a receptacle assembly, and a guide bundle. [Figure 7] FIG. 1 is a rear view of a portion of an embodiment of a catheter system, including an embodiment of an alignment assembly and a receptacle assembly. [Figure 8] FIG. 1 is a side view of a portion of an embodiment of a catheter system, including an embodiment of an alignment assembly and a receptacle assembly. [Figure 9] FIG. 1 is a top view of a portion of an embodiment of a catheter system, including an embodiment of an alignment assembly and a receptacle assembly. [Figure 10] FIG. 10 is a cross-sectional view of a portion of an embodiment of a catheter system taken along line 10-10 of FIG. [Figure 11] 1 is a flow chart illustrating one embodiment of a method for aligning a light source in a catheter system, in accordance with various embodiments herein. [Figure 12] 1 is a flow chart illustrating an embodiment of a method for performing coarse alignment of a light source in a catheter system. [Figure 13] 10 is a flow chart illustrating yet another embodiment of a method for aligning a light source in a catheter system. [Figure 14] 1 is a diagram of an embodiment of an end face of a light guide captured by a camera during an embodiment of a method for aligning a light source within a catheter system. [Figure 15]1 is another view of an end face of a light guide captured by a camera during one embodiment of a method for aligning a light source within a catheter system. [Figure 16] 13 is yet another view of an end face of a light guide captured by a camera during an embodiment of a method for aligning a light source within a catheter system. [Figure 17] 13 is yet another view of an end face of a light guide captured by a camera during an embodiment of a method for aligning a light source within a catheter system. [Figure 18] 1 is a diagram of a user interface displaying an overlay surface used during one embodiment of a method for aligning a light source within a catheter system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0082] While embodiments of the invention are susceptible to various modifications and alternatives, details thereof have been shown by way of example and drawings and are described in detail herein. It is understood, however, that the scope of the specification is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives that are within the spirit and scope of the specification.

[0083] Treatment of vascular lesions can reduce major adverse events or deaths in affected subjects. As referred to herein, major adverse events are adverse events that may occur anywhere in the body due to the presence of vascular lesions. Major adverse events may include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in the muscular system, or major adverse events in any of the internal organs.

[0084] For the treatment of vascular lesions, such as calcifications in arteries, it is generally beneficial to treat multiple closely spaced areas with a single insertion and positioning of a catheter balloon. To be able to do this in an optical excitation system, such as in a laser-driven intravascular lithotripsy device, it is usually desirable to have several output channels, e.g. optical fibers and targets, for the treatment process, which can be distributed in the balloon. Since the high-power laser source is often the largest and most expensive component in the system, having a dedicated laser source for each optical fiber is unlikely to be feasible for several reasons, including packaging requirements, power consumption, thermal considerations, and economic aspects. For such reasons, it may be advantageous to multiplex a single laser simultaneously and / or sequentially into several different optical fibers for treatment purposes. This allows for the use of all or a specific portion of the laser output from a single laser in each fiber.

[0085] Thus, the catheter system and associated methods are configured to provide a means to use a single light source to power multiple fiber optic channels in a laser-driven pressure wave generator designed to apply pressure to and induce fragmentation of vascular lesions, such as calcified and / or fibrous vascular lesions. More specifically, the present invention includes a multiplexer that multiplexes a single light source, e.g., a single laser source, to one or more of multiple light guide, e.g., fiber optic channels, within a disposable device.

[0086] One of the problems with using optical fibers to transmit high energy light pulses is that there can be significant limitations on the amount of energy that can be carried by an optical fiber due to concerns of physical damage and nonlinear processes such as stimulated Brillouin scattering (SBS). For this reason, it can be advantageous to have the option of simultaneously accessing multiple fibers, or light guides, to increase the amount of energy that can be delivered at one time without directing too much energy through a single fiber. The present technology further allows a single stable light source to be sent sequentially through a variable number of multiple light guides.

[0087] In various embodiments, the catheter systems and associated methods disclosed herein can include a catheter configured to be advanced to a vascular lesion, such as a calcified or fibrous vascular lesion, located at a treatment site within or adjacent to a blood vessel within a patient's body. The catheter can include a catheter shaft and an inflatable balloon coupled and / or secured to the catheter shaft. The balloon can include a balloon wall defining a balloon interior. The balloon can be configured to receive a balloon fluid within the balloon interior to expand from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for securing the catheter in position relative to the treatment site.

[0088] The catheter system also includes a plurality of light guides disposed within the balloon interior of the balloon along the catheter shaft. Each light guide can be configured to generate a pressure wave within the balloon to destroy the vascular lesion. In particular, the catheter system utilizes light energy from the light source to generate a localized plasma in a balloon fluid within the balloon interior of the balloon at or near a guide distal end of the light guide disposed within the balloon located at the treatment site. Thus, the light guide may be referred to as or may incorporate a "plasma generator" at or near a guide distal end of the light guide positioned within the balloon interior of the balloon located at the treatment site. The generation of the localized plasma can initiate a pressure wave and can initiate the rapid formation of one or more high energy bubbles that can rapidly expand to a maximum size and then dissipate via a cavitation event that can emit a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles can generate one or more pressure waves within the balloon fluid held within the balloon interior of the balloon, thereby imparting pressure waves to vascular lesions at the treatment site within or adjacent to a vascular wall within the patient's body, inducing disruption. It will be appreciated that the distal guide end of each of the multiple optical guides may be positioned at any suitable location relative to the length of the balloon to more effectively and precisely deliver pressure waves to destroy vascular lesions at the treatment site.

[0089] In some embodiments, the light source can be configured to provide sub-millisecond pulses of light energy to initiate plasma formation in the balloon fluid within the balloon, causing rapid bubble formation and imparting pressure waves to the balloon wall at the treatment site. The pressure waves can thus transfer mechanical energy through the incompressible balloon fluid to the treatment site to impart a disruptive force to the vascular lesion. Without wishing to be bound by any particular theory, it is believed that rapid changes in balloon fluid momentum on the balloon wall in contact with the intravascular lesion are transferred to the intravascular lesion, inducing disruption to the lesion.

[0090] Importantly, as described above, the catheter system and associated methods include a multiplexer that multiplexes a single light source to one or more of the light guides within a disposable device to enable treatment of multiple closely spaced areas with a single insertion and positioning of the catheter balloon.

[0091] As used herein, the terms "intravascular lesion" and "vascular lesion" are used interchangeably unless otherwise specified. Thus, intravascular lesions and / or vascular lesions may be referred to herein simply as "lesions."

[0092] Those skilled in the art will understand that the following detailed description of the invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the invention will readily suggest themselves to such skilled artisans having the benefit of this disclosure. Reference will now be made in detail to the embodiments of the invention illustrated in the accompanying drawings. Throughout the drawings and the following detailed description, the same or similar names and / or reference indicators will be used to refer to the same or similar parts.

[0093] For clarity, not all of the routine features of the implementations described herein are shown and described. It will be understood that in the development of any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's particular goals, such as compliance with application-related and business-related constraints, and that these particular goals will vary from implementation to implementation and from developer to developer. Moreover, it will be understood that such a development effort may be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0094] The catheter system disclosed herein can include many different configurations. Referring now to FIG. 1, a schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to apply pressure waves to induce disruption of one or more vascular lesions in or adjacent to a vessel wall of a blood vessel within a patient's body. In the embodiment shown in FIG. 1, the catheter system 100 includes a catheter 102, a light guide bundle 122 including one or more (preferably multiple) light guides 122A, a source manifold 136, a fluid pump 138, a system console 123 including one or more of a light source 124, a power supply 125, a system controller 126, a graphic user interface 127 ("GUI"), and a multiplexer 128, and one or more of a handle assembly 129. Alternatively, the catheter system 100 can include more or fewer components than those specifically shown and described in connection with FIG. 1.

[0095] The catheter 102 is configured to navigate to a treatment site 106 within or adjacent to a vascular wall 108A of a blood vessel 108 in a body 107 of a patient 109. The treatment site 106 can include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 can include a vascular lesion 106A, such as a fibrous vascular lesion.

[0096] The catheter 102 may include an inflatable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter shaft 110 may also include a guidewire lumen 118 configured to travel over the guidewire 112. As utilized herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflation lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal end opening 120 to accommodate and pass over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft 110 and the balloon distal end 104D can be coupled to the guidewire lumen 118.

[0097] The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a balloon fluid 132 to expand from a contracted state suitable for advancing the catheter 102 through the patient's vasculature to an inflated state (as shown in FIG. 1 ) suitable for fixing the catheter 102 in a predetermined position relative to the treatment site 106. Stated differently, when the balloon 104 is in an inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106, i.e., the vascular lesion 106A of the treatment site 106. While FIG. 1 illustrates the balloon wall 130 of the balloon 104 shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, it will be understood that this is done merely for ease of illustration. It will be appreciated that the balloon wall 130 of the balloon 104 will typically be substantially directly adjacent and / or abutting the treatment site 106 when the balloon 104 is in the inflated state.

[0098] Balloons 104 suitable for use in the catheter system 100 include those that, when in a deflated state, can pass through the vasculature of a patient 109. In some embodiments, the balloon 104 is made from silicone. In other embodiments, the balloon 104 can be made from polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX™ material, nylon, or any other suitable material.

[0099] The balloon 104 can have any suitable diameter (in an inflated state). In various embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from less than 1 millimeter (mm) to 25 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 1.5 mm to 14 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 2 mm to 5 mm.

[0100] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is understood that a balloon 104 having a relatively long length can be positioned adjacent a larger treatment site 106 and thus can be used to impart pressure waves to induce fragmentation at a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further understood that a longer balloon 104 can also be positioned adjacent multiple treatment sites 106 at any given time.

[0101] The balloon 104 may be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 may be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0102] The balloon 104 can have a variety of shapes, including, but not limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical / square shape, a conical / spherical shape, an elongated spherical shape, an elliptical shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.

[0103] The balloon fluid 132 may be a liquid or a gas. Some examples of balloon fluids 132 suitable for use may include, but are not limited to, one or more of water, saline, contrast medium, a gas such as a fluorocarbon, a perfluorocarbon, carbon dioxide, or any other suitable balloon fluid 132. In some embodiments, the balloon fluid 132 may be used as a base inflation fluid. In some embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 50:50. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 25:75. In yet other embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 75:25. However, it is understood that any suitable ratio of saline to contrast medium may be used. The balloon fluid 132 may be adjusted based on composition, viscosity, etc., such that the speed of travel of the pressure wave is appropriately manipulated. In certain embodiments, the balloon fluid 132 suitable for use herein is biocompatible. The volume of the balloon fluid 132 can be adjusted depending on the light source 124 selected and the type of balloon fluid 132 used.

[0104] In some embodiments, the contrast agent used in the contrast medium may include, but is not limited to, an iodine-based contrast agent, such as an ionic or non-ionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium (III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0105] The balloon fluid 132 can include those containing absorbers capable of selectively absorbing light in the ultraviolet (e.g., at least 10 nanometers (nm) to 400 nm), visible (e.g., at least 400 nm to 780 nm), or near infrared (e.g., at least 780 nm to 2.5 μm) regions of the electromagnetic spectrum. Suitable absorbers can include those having an absorption maximum along a spectrum of at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 can include absorbers capable of selectively absorbing light in the mid-infrared (e.g., at least 2.5 μm to 15 μm) or far-infrared (e.g., at least 15 μm to 1 mm) regions of the electromagnetic spectrum. In various embodiments, the absorbers can be those having an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. As non-limiting examples, various lasers described herein may include a neodymium:yttrium-aluminum-garnet (Nd:YAG-emission maximum=1064 nm) laser, a holmium:YAG (Ho:YAG-emission maximum=2.1 μm) laser, or an erbium:YAG (Er:YAG-emission maximum=2.94 μm) laser. In some embodiments, the absorber may be water soluble. In other embodiments, the absorber is not water soluble. In some embodiments, the absorber used in the balloon fluid 132 may be tailored to match the peak emission of the light source 124. Various light sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0106] The catheter shaft 110 of the catheter 102 may be coupled to one or more light guides 122A of the light guide bundle 122 in optical communication with the light source 124. The light guide(s) 122A may be disposed within the balloon 104 along the catheter shaft 110. Each of the light guides 122A may have a guide distal end 122D at any suitable longitudinal position relative to the length of the balloon 104. In some embodiments, each light guide 122A may be an optical fiber and the light source 124 may be a laser. The light source 124 may be in optical communication with the light guides 122A at the proximal portion 114 of the catheter system 100. More specifically, the light source 124 may be in optical communication selectively, simultaneously, sequentially, and / or alternatively with each of the light guides 122A in any desired combination, order, and / or pattern due to the presence and operation of the multiplexer 128, as described in detail herein.

[0107] In some embodiments, the catheter shaft 110 may be coupled to multiple light guides 122A, such as a first light guide, a second light guide, a third light guide, etc., that may be positioned at any suitable location around the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two light guides 122A may be spaced approximately 180 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, three light guides 122A may be spaced approximately 120 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, or four light guides 122A may be spaced approximately 90 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Additionally alternatively, the multiple light guides 122A need not be uniformly spaced from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, the light guides 122A can be uniformly or non-uniformly positioned about the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0108] The catheter system 100 and / or light guide bundle 122 may include any number of light guides 122A in optical communication with the light source 124 at the proximal portion 114 and the balloon fluid 132 in the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or light guide bundle 122 may include from one light guide 122A to five light guides 122A. In other embodiments, the catheter system 100 and / or light guide bundle 122 may include from five light guides 122A to fifteen light guides 122A. In yet other embodiments, the catheter system 100 and / or light guide bundle 122 may include from ten light guides 122A to thirty light guides 122A. Alternatively, in still other embodiments, the catheter system 100 and / or light guide bundle 122 may include more than thirty light guides 122A.

[0109] The light guide 122A may have any suitable design for the purpose of generating plasma and / or pressure waves in the balloon fluid 132 within the balloon interior 146. In certain embodiments, the light guide 122A may include an optical fiber or a flexible light pipe. The light guide 122A may be thin and flexible, allowing for the transmission of optical signals with little loss of intensity. The light guide 122A may include a core surrounded by a cladding. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the light guide 122A may be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The light guide 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core is greater than the refractive index of the cladding.

[0110] Each light guide 122A can direct light energy along its length from a proximal guide end 122P to a distal guide end 122D having at least one optical window (not shown) positioned within the balloon interior 146.

[0111] The light guide 122A can take on many configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the light guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the light guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the light guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the light guide 122A can be disposed within one or more light guide lumens within the catheter shaft 110.

[0112] The optical guides 122A may also be positioned at any suitable location around the guidewire lumen 118 and / or catheter shaft 110, and the guide distal ends 122D of each of the optical guides 122A may be positioned at any suitable longitudinal position relative to the length of the balloon 104 and / or relative to the length of the guidewire lumen 118 to more effectively and precisely apply pressure waves for the purpose of destroying vascular lesions 106A at the treatment site 106.

[0113] In certain embodiments, the light guide 122A can include one or more optoacoustic transducers 154, and each optoacoustic transducer 154 can be in optical communication with the light guide 122A in which it is disposed. In some embodiments, the optoacoustic transducer 154 can be in optical communication with the guide distal end 122D of the light guide 122A. Furthermore, in such embodiments, the optoacoustic transducer 154 can have a shape that corresponds to and / or matches the guide distal end 122D of the light guide 122A.

[0114] The photoacoustic transducer 154 is configured to convert light energy into acoustic waves at or near the distal guide end 122D of the light guide 122A. The direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the light guide 122A.

[0115] In certain embodiments, the optoacoustic transducer 154 disposed at the guide distal end 122D of the light guide 122A can have the same shape as the guide distal end 122D of the light guide 122A. For example, in certain non-exclusive embodiments, the optoacoustic transducer 154 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The light guide 122A can further include additional optoacoustic transducers 154 disposed along one or more sides of the length of the light guide 122A.

[0116] In some embodiments, the light guide 122A can further include one or more redirecting mechanisms or "diverters" (not shown in FIG. 1) within the light guide 122A configured to direct light to exit the light guide 122A toward a side surface that may be located at or near the guide distal end 122D of the light guide 122A and toward the balloon wall 130. The redirecting mechanism can include any mechanism of the system that redirects light energy from the light guide 122A away from its axial path toward a side surface of the light guide 122A. Additionally, the light guides 122A can each include one or more optical windows disposed along a longitudinal or circumferential surface of each light guide 122A and in optical communication with the redirecting mechanism. Stated another way, the redirecting mechanism can be configured to direct light energy within the light guide 122A toward a side surface that is at or near the guide distal end 122D, the side surface being in optical communication with the optical window. An optical window can include a portion of the light guide 122A that allows light energy to exit the light guide 122A from within the light guide 122A, for example, a portion of the light guide 122A that has no cladding material on or around it.

[0117] Examples of redirecting mechanisms suitable for use include reflective elements, refractive elements, and fiber diffusers. Redirecting mechanisms suitable for focusing the optical energy away from the tip of the light guide 122A can include, but are not limited to, those with convex surfaces, gradient index (GRIN) lenses, and mirror focus lenses. Upon contact with the redirecting mechanism, the optical energy is redirected within the light guide 122A to one or more of the plasma generator 133 and the optoacoustic transducer 154, which is in optical communication with the sides of the light guide 122A. As described above, the optoacoustic transducer 154 converts the optical energy into acoustic waves that extend away from the sides of the light guide 122A.

[0118] The source manifold 136 may be positioned at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal end openings that may receive one or more light guides 122A of the light guide bundle 122, the guidewire 112, and / or an inflation conduit 140 that is coupled in fluid communication with a fluid pump 138. The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132, i.e., via the inflation conduit 140, as needed.

[0119] As mentioned above, in the embodiment shown in FIG. 1, the system console 123 includes one or more of the light source 124, the power source 125, the system controller 126, the GUI 127, and the multiplexer 128. Alternatively, the system console 123 may include more or fewer components than those specifically shown in FIG. 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Further alternatively, one or more of the light source 124, the power source 125, the system controller 126, the GUI 127, and the multiplexer 128 may be provided in the catheter system 100 without the specific need for a system console 123.

[0120] As shown, the system console 123, and the components included therein, are operatively coupled to the catheter 102, the light guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as shown in FIG. 1, the system console 123 can include a console connection opening 148 (sometimes commonly referred to as a "socket") through which the light guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the light guide bundle 122 can include a guide coupling housing 150 (sometimes commonly referred to as a "ferrule") that accommodates a portion of each of the light guides 122A, e.g., the guide proximal end 122P. The guide coupling housing 150 is configured to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the light guide bundle 122 and the system console 123.

[0121] The light guide bundle 122 may also include a guide bundle 152 (or "shell") that brings each of the individual light guides 122A closer together, thereby allowing the light guides 122A and / or the light guide bundle 122 to assume a more compact form when extended into the blood vessel 108 with the catheter 102 during use of the catheter system 100.

[0122] The light source 124 may be in optical communication with each of the light guides 122A within the light guide bundle 122, i.e., selectively and / or alternatively coupled to the guide proximal end 122P of each of the light guides 122A. In particular, the light source 124 is configured to generate light energy in the form of a light source beam 124A, such as a pulsed light source beam, which may be selectively and / or alternatively directed to and received by each of the light guides 122A within the light guide bundle 122 in any desired combination, sequence, order, and / or pattern. More specifically, as described in more detail herein below, the light source beam 124A from the light source 124 is directed through a multiplexer 128 such that individual guide beams 124B (or "multiple beams") may be selectively and / or alternatively directed to and received by each of the light guides 122A within the light guide bundle 122. In particular, each pulse of light source 124, i.e., each pulse of light source beam 124A, can be directed through multiplexer 128 to generate one or more separate guide beams 124B (only one is shown in FIG. 1) that are selectively and / or alternatively directed to one or more of the light guides 122A in the light guide bundle 122.

[0123] The light source 124 may have any suitable design. In certain embodiments, the light source 124 may be configured to provide sub-millisecond pulses of light energy from the light source 124 that are focused onto a small spot for coupling to the proximal guide end 122P of the light guide 122A. Such pulses of light energy are then guided and / or directed along the light guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the balloon fluid 132 within the balloon interior 146 of the balloon 104, for example, via a plasma generator 133 that may be located at the distal guide end 122D of the light guide 122A. In particular, light emitted at the distal guide end 122D of the light guide 122A excites the plasma generator 133 to form plasma within the balloon fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation, imparting a pressure wave to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG. 1.

[0124] In various non-exclusive alternative embodiments, sub-millisecond pulses of light energy from the light source 124 may be delivered to the treatment site 106 at frequencies between about 1 Hertz (Hz) and 5000 Hz, between about 30 Hz and 1000 Hz, between about 10 Hz and 100 Hz, or between about 1 Hz and 30 Hz. Alternatively, sub-millisecond pulses of light energy may be delivered to the treatment site 106 at frequencies that may be greater than 5000 Hz or less than 1 Hz, or any other suitable frequency range.

[0125] Although light source 124 is typically utilized to provide pulses of light energy, it is understood that light source 124 may be described as providing a single light source beam 124A, i.e., a single pulsed light source beam.

[0126] Light sources 124 suitable for use herein can include various types of light sources including lasers and lamps. Suitable lasers can include short pulse lasers on the sub-millisecond timescale. In some embodiments, light sources 124 can include lasers on the nanosecond (ns) timescale. Lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is understood that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be employed to achieve a plasma in the balloon fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, pulse widths can include those in the ranges including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0127] Exemplary nanosecond lasers can include those in the UV to IR spectrum, spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, light source 124 suitable for use in catheter system 100 can include those capable of generating light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, light source 124 can include those capable of generating light with wavelengths of at least 700 nm to 3000 nm. In still other embodiments, light source 124 can include those capable of generating light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having repetition rates up to 200 kHz. In some embodiments, the laser can include a Q-switched Thulium:Yttrium-Aluminum-Garnet (Tm:YAG) laser. In other embodiments, the laser may include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped pulsed fiber laser.

[0128] The catheter system 100 can generate pressure waves having a maximum pressure in the range of at least 1 Megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 depends on the light source 124, the absorbing material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate pressure waves having a maximum pressure in the range of at least about 2 MPa to 50 MPa, at least about 2 MPa to 30 MPa, or at least about 15 MPa to 25 MPa.

[0129] The pressure waves may be applied on the treatment site 106 from a distance ranging from at least about 0.1 millimeters (mm) to greater than about 25 mm extending radially from the energy guide 122A when the catheter 102 is placed on the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves may be applied on the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm extending radially from the energy guide 122A when the catheter 102 is placed on the treatment site 106. In other embodiments, the pressure waves may be applied on the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure waves may be applied on the treatment site 106 in a range of at least about 2 MPa to 30 MPa at a distance of at least about 0.1 mm to 10 mm. In some embodiments, pressure waves may be applied onto the treatment site 106 in the range of at least about 2 MPa to 25 MPa at a distance of at least about 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances may be used.

[0130] The power supply 125 is electrically coupled to each of the light sources 124, the system controller 126, the GUI 127, the multiplexer 128, and the handle assembly 129 and configured to provide the necessary power. The power supply 125 may have any suitable design for such purposes.

[0131] The system controller 126 is electrically coupled to the power source 125 and receives power therefrom. Additionally, the system controller 126 is coupled to each of the light sources 124, the GUI 127, and the multiplexer 128 and configured to control their operation. The system controller 126 may include one or more processors or circuits for the purpose of controlling the operation of at least the light sources 124, the GUI 127, and the multiplexer 128. For example, the system controller 126 may control the light sources 124 to generate pulses of light energy as desired and / or at any desired firing rate. Thereafter, the system controller 126 may then control the multiplexer 128 such that the light energy from the light sources 124, i.e., the light source beams 124A, may be effectively and precisely multiplexed and thereby selectively and / or alternatively directed to each of the light guides 122A in the form of individual guide beams 124B in a desired manner.

[0132] The system controller 126 may be further configured to control the operation of other components of the catheter system 100, such as positioning of the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with balloon fluid 132, etc. Additionally or alternatively, the catheter system 100 may include one or more additional controllers, which may be positioned in any suitable manner to control various operations of the catheter system 100. For example, in certain embodiments, the additional controllers and / or portions of the system controller 126 may be positioned and / or incorporated within the handle assembly 129.

[0133] The GUI 127 is accessible by a user or operator of the catheter system 100. Additionally, the GUI 127 is electrically connected to the system controller 126. With such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure on the vascular lesion 106A of the treatment site 106 to induce fragmentation. The GUI 127 can provide information to the user or operator that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 can provide dynamic visual data and / or information to the user or operator, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, changing brightness, etc., that can serve as an alert to the user or operator. Additionally or alternatively, the GUI 127 can provide audio data or information to the user or operator. The details of the GUI 127 may vary depending on the design requirements of the catheter system 100 or the particular needs, specifications, and / or desires of a user or operator.

[0134] As provided herein, the multiplexer 128 is configured to selectively and / or alternatively direct optical energy from the light source 124 to each of the light guides 122A in the light guide bundle 122. More specifically, the multiplexer 128 is configured to receive optical energy from a single light source 124, such as a single light source beam 124A from a single laser source, and selectively and / or alternatively direct such optical energy in the form of individual guide beams 124B to each of the light guides 122A in the light guide bundle 122 in any desired combination (i.e., simultaneously directing optical energy through multiple light guides 122A), sequence, order, and / or pattern. In this manner, the multiplexer 128 enables the single light source 124 to be sent simultaneously and / or sequentially through multiple light guides 122A such that the catheter system 100 can apply pressure to induce disruption on vascular lesions at the treatment site 106 within or adjacent to the vascular wall 108A of the blood vessel 108 in a desired manner. Additionally, as shown, the catheter system 100 can include one or more optical elements 147 for directing optical energy in the form of source beam 124A from the light source 124 to the multiplexer 128. The multiplexer 128 can have at least a single degree of freedom relative to the axes shown and described herein.

[0135] The multiplexer 128 may have any suitable design for selectively and / or alternatively directing light energy from the light sources 124 to each of the light guides 122A of the light guide bundle 122. In some embodiments, the multiplexer 128 may include a camera 128C. In other embodiments, the camera 128C may be located outside of the multiplexer 128. In certain embodiments, the camera 128C may be included as part of an alignment assembly 256 (shown in FIG. 2).

[0136] The camera 128C may vary depending on the design requirements of the catheter system 100. For example, in some embodiments, the camera 128C may include an illumination source such as a light emitting diode (or the illumination source may be separate from the camera 128C). The camera 128C may capture an image of the guide proximal end 122P of the light guide 122A so that the alignment of the individual guide beams 124B relative to the guide proximal end 122P may be adjusted. The system controller 126 may use the images captured by the camera 128C to generate an XYZ coordinate reference plane. When the alignment hardware is moved to a first position, the camera 128C may be utilized as a machine vision to detect a first picture. One or more cameras 128C may capture an image taken at the first position. The camera 128C may continue to capture images until all reference targets are captured. The system controller 126 may generate a camera offset based on the images generated by the camera 128C.

[0137] 1, the handle assembly 129 can be positioned at or near the proximal portion 114 of the catheter system 100 and / or near the source manifold 136. In this embodiment, the handle assembly 129 is coupled to and positioned spaced apart from the balloon 104. Alternatively, the handle assembly 129 can be positioned in another suitable location.

[0138] The handle assembly 129 is handled and used by a user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 129 can be varied to suit the design requirements of the catheter system 100. In the embodiment shown in FIG. 1, the handle assembly 129 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the light source 124, the fluid pump 138, the GUI 127, and the multiplexer 128. In some embodiments, the handle assembly 129 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 129. For example, as shown, in certain such embodiments, the handle assembly 129 can include circuitry 155 that can form at least a portion of the system controller 126. In one embodiment, the circuitry 155 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In alternative embodiments, the circuitry 155 may be omitted or may be included within the system controller 126, and in various embodiments, the circuitry 155 may be located outside the handle assembly 129, such as in the system console 123. It is understood that the handle assembly 129 may include fewer or additional components than those specifically shown and described herein.

[0139] 2 is a partially exploded perspective view of a portion of one embodiment of a catheter system 200, including a guide bundle 252, an alignment assembly 256, and a receptacle assembly 274. As shown in the embodiment depicted in FIG.

[0140] The design of the catheter system 200 may be substantially similar to the embodiments shown and described herein. It is understood that various components of the catheter system 200 as shown in Figure 1 are not shown in Figure 2 for clarity and ease of illustration, such as the multiplexer 128 (shown in Figure 1). However, it is understood that the catheter system 200 will likely include some, if not all, of such components.

[0141] 2, the catheter system 200 again includes a guide bundle 252 including a guide bundle housing 253 that brings each of the individual light guides 122A (shown in FIG. 1) closer together, thereby allowing the light guides 122A and / or guide bundle 252 to assume a more compact configuration when extended within a blood vessel 108 (shown in FIG. 1) with the catheter 102 (shown in FIG. 1) during use of the catheter system 200. The guide bundle 252 can also include a guide bundle ferrule 270 configured to optically couple a guide beam 124B (shown in FIG. 1) from the multiplexer 128 to a corresponding light guide 122A.

[0142] The alignment assembly 256 may be configured to precisely adjust the alignment and / or positioning between the guide beam 124B exiting the multiplexer 128 and each of the corresponding individual light guides 122A that receive the corresponding guide beam 124B. The alignment assembly 256 may adjust the alignment and / or positioning to within micrometer level adjustments for any of the individual light guides 122A. In other words, the alignment assembly 256 may adjust the position of the individual guide beams 124B relative to the receptacle assembly 274 (or any other suitable component of the catheter system 200) to within single digit micrometers. The alignment assembly 256 may adjust the alignment and / or positioning of the various components of the catheter system 200 at the time of initial connection of the guide bundle 252.

[0143] The alignment assembly 256 can align the light energy from the light sources 124 (shown in FIG. 1 ) such that the light energy in the form of the individual guide beams 124B is aligned within each of the guide proximal ends 122P of the light guide 122A. The alignment assembly 256 can adjust the alignment and / or positioning of the individual guide beams 124B relative to the receptacle assembly 274 and / or the light guide 122A. In some embodiments, the alignment assembly 256 can simultaneously adjust the positioning and / or alignment of the light guide 122A, the individual guide beams 124B, the multiplexer 128, and / or the receptacle assembly 274. The alignment assembly 256 can adjust the positioning of the guide proximal end 122P of the light guide 122A such that the guide proximal end 122P has one, two, or three degrees of freedom (rotation and / or translation). The alignment assembly 256 can adjust the positioning of the receptacle assembly 274 so that the receptacle assembly 274 has one, two, or three degrees of freedom (rotation and / or translation). The alignment assembly 256 can adjust the positioning of the receptacle assembly 274 relative to the multiplexer 128.

[0144] The alignment assembly 256 may vary depending on the design requirements of the catheter system 200, the type, size, and / or configuration of the multiplexer 128, the guide bundle 252, and / or the receptacle assembly 274. It is understood that the alignment assembly 256 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the alignment assembly 256 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, the various components of the alignment assembly 256 may be positioned differently than those specifically illustrated in FIG. 2.

[0145] The alignment assembly 256 can include a stationary base 257, a first stage 258, a first stage knob 259, a second stage 260, a second stage knob 262, a rotating cam 264, and a mover 266. Additionally, as shown in the embodiment depicted in FIG. 2, the alignment assembly 256 can be configured to engage and / or couple to the guide bundle 252 and / or the receptacle assembly 274. The alignment assembly 256 can be coupled to the multiplexer 128. In some embodiments, the alignment assembly 256 can include a camera 128c (e.g., as shown in FIG. 1). The camera 128c can capture an image of the guide proximal end 122P of each light guide 122A such that the position of the individual guide beams 124B relative to the guide proximal end 122P can be adjusted.

[0146] The stationary base 257 may be configured as a base structure to which all the various components of the alignment assembly 256 are attached. For example, as shown in the embodiment depicted in FIG. 2, the second stage 260 may be affixed, coupled, attached, and / or otherwise engaged to the stationary base 257. The stationary base 257 may vary depending on the design requirements of the catheter system 200, the type, size, and / or configuration of the multiplexer 128, the guide bundle 252, the alignment assembly 256, and / or the receptacle assembly 274. It is understood that the stationary base 257 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the stationary base 257 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, the various components of the stationary base 257 may be positioned differently than those specifically illustrated in FIG. 2.

[0147] The first stage 258 may rotate about and / or move along any suitable axis. The first stage 258 may rotate about and / or move along a first axis 470X (shown in FIG. 4), a second axis 470Y (shown in FIG. 4), and a third axis 470Z (shown in FIG. 4). The first stage 258 may rotate and / or move along any number of suitable axes as required by the design requirements of the alignment assembly 256. The first stage 258 may be selectively secured and / or coupled to the receptacle assembly 274.

[0148] In some embodiments, the first stage 258 is rotated by a power train-like system, and the first stage knob 259 is rotated by a mover 266. In other embodiments, the first stage 258 is coupled to a rotating cam 264 that controls the rotational movement of the first stage 258 about the light guide axis. In various embodiments, the first stage 258 can rotate on rollers 263 configured to move in cooperation with the rotational movement of the first stage 258. In some embodiments, the cams described herein (such as the rotating cam 264) can be replaced with linearly moving rods or screws that move the knobs described herein (such as the first stage knob 259) in any suitable direction. The first stage knob 259 can be selectively engaged with the rotating cam 264. The rotating cam 264 can be coupled to the mover 266.

[0149] The first stage 258 may vary depending on the design requirements of the catheter system 200, the type, size, and / or configuration of the multiplexer 128, the guide bundle 252, the alignment assembly 256, and / or the receptacle assembly 274. It is understood that the first stage 258 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the first stage 258 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, various components of the first stage 258 may be positioned differently than those specifically illustrated in FIG. 2.

[0150] The first stage 258 may be configured to receive and / or engage the receptacle assembly 274. In some embodiments, the first stage 258 rotates the receptacle assembly 274 such that both components rotate simultaneously. In other embodiments, the first stage 258 may be integrally formed with the receptacle assembly 274.

[0151] The second stage 260 can raise and lower the first stage 258. In some embodiments, the second stage 260 can move the first stage 258 using a second stage knob 262. The second stage 260 can rotate about and / or move along any suitable axis. The second stage 260 can rotate about and / or move along a first axis 470X (shown in FIG. 4), a second axis 470Y (shown in FIG. 4), and a third axis 470Z (shown in FIG. 4). The second stage 260 can rotate and / or move along any number of suitable axes as required by the design requirements of the alignment assembly 256. In other embodiments, the second stage 260 can be configured to move the first stage 258 horizontally (along the x-axis). The second stage 260 can move about the first axis of the second stage (e.g., the second axis 470Y). The second stage 260 may be selectively secured to the first stage 258 .

[0152] The second stage 260 may vary depending on the design requirements of the catheter system 200, the type, size, and / or configuration of the multiplexer 128, the guide bundle 252, the alignment assembly 256, and / or the receptacle assembly 274. It is understood that the second stage 260 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the second stage 260 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, various components of the second stage 260 may be positioned differently than those specifically illustrated in FIG. 2.

[0153] The second stage 260 may be configured to receive and / or engage the first stage 258 and / or the receptacle assembly 274. In some embodiments, the second stage 260 moves in coordination with the first stage 258 and / or the receptacle assembly 274. In other embodiments, the second stage 260 may be integrally formed with the first stage 258 and / or the receptacle assembly 274.

[0154] The second stage knob 262 may be spring loaded and may engage another cam (not shown). The second stage knob 262 may be driven by a mover 266. Rotational movement of the mover 266 may drive the second stage knob 262 into engagement with the rotating cam 264, resulting in reciprocating movement of the second stage 260.

[0155] The second stage knob 262 may vary depending on the design requirements of the catheter system 200, the type, size, and / or configuration of the alignment assembly 256, the first stage 258, the second stage 260, and / or the receptacle assembly 274. It is understood that the second stage knob 262 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the second stage knob 262 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, various components of the second stage knob 262 may be positioned differently than those specifically illustrated in FIG. 2.

[0156] The receptacle assembly 274 may be configured to align the guide bundle ferrules 270 such that the guide bundle ferrules 270 are arranged in a linear array with a known pitch. In some embodiments, the receptacle assembly 274 may precisely align and / or position the guide proximal end 122P and / or the guide bundle ferrules 270 of the light guide 122A within a single digit micrometer of error. The receptacle assembly 274 may receive the guide proximal end 122P and / or the guide bundle ferrules 270 such that the guide proximal end 122P and / or the guide bundle ferrules 270 are fixed along a receptacle ferrule receiver axis 576X (e.g., as shown in FIG. 5 ). The receptacle assembly 274 may be coupled to the alignment assembly 256.

[0157] The receptacle assembly 274 may vary depending on the design requirements of the catheter system 200, the type, size, and / or configuration of the multiplexer 128, the guide bundle 252, and / or the alignment assembly 256. It is understood that the receptacle assembly 274 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the receptacle assembly 274 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, the various components of the receptacle assembly 274 may be positioned differently than those specifically illustrated in FIG. 2. Further details of the receptacle assembly 274 are shown in FIG. 5 and described further herein.

[0158] 3 is a front view of a portion of an embodiment of a catheter system 300, including an embodiment of an alignment assembly 356 and a receptacle assembly 374. As shown in the embodiment shown in FIG. 3, the catheter system 300 can include an alignment assembly 356, which can include a stationary base 357, a first stage 358, a first stage knob 359, a second stage 360, a second stage knob 362, a roller 363, and a rotating cam 364, and a receptacle assembly 374, which can include a receptacle ferrule receiver 376, a receptacle assembly housing 378, and a receptacle ferrule retainer 380. The receptacle ferrule receiver 376, the receptacle assembly housing 378, and the receptacle ferrule retainer 380 are described in further detail herein.

[0159] 4 is a perspective view of a portion of an embodiment of a catheter system 100, including an embodiment of a guide bundle 452. As shown in the embodiment depicted in FIG. 4, the guide bundle 452 can include a guide bundle housing 453, a guide bundle ferrule 470, and a guide bundle opening 472.

[0160] The guide bundle 452 bundles multiple light guides 122A (shown in FIG. 1 ) into individual corresponding guide bundle ferrules 470. Each of the guide bundle ferrules 470 has at least one degree of freedom. In some embodiments, the guide bundle ferrules 470 have degrees of freedom about a first axis 470X, a second axis 470Y, a third axis 470Z, a first axis of rotation 470P, a second axis of rotation 470Q, a third axis of rotation 470R, and / or any suitable axis. In various embodiments, any axis may be the first axis 470X, the second axis 470Y, and / or the third axis 470Z. In various embodiments, the axes described herein may be substantially orthogonal to one another, as shown in FIG. 4 .

[0161] The guide bundle ferrule 470 can include a spring 470S such that the guide bundle ferrule 470 is spring-biased into the guide bundle 452 from which it projects. In some embodiments, the spring 470S can provide a spring force to urge the ferrule 470 along the first axis 470X, the second axis 470Y, and / or the third axis 470Z. The guide bundle opening 472 through which the ferrule 470 projects is large enough to accommodate small movements applied by an alignment correction mechanism that may be provided by the alignment assembly 256 (shown in FIG. 2). The guide bundle ferrules 470 can each move about the first axis 470X, the second axis 470Y, the third axis 470Z, the first axis of rotation 470P, the second axis of rotation 470Q, and / or the third axis of rotation 470R. The use of first, second, and third with respect to axes and / or stages is merely for clarity, with it being understood that in some embodiments the first, second, and third axes and / or stages are the same axes and / or stages. In other embodiments the first, second, and third axes and / or stages are different axes and / or stages. In some embodiments the first axis 470X, the second axis 470Y, and / or the third axis 470Z are substantially orthogonal to one another.

[0162] 5 is a perspective view of a portion of an embodiment of a catheter system 500, including an embodiment of a receptacle assembly 574. In some embodiments, the receptacle assembly 574 can include a receptacle ferrule receiver 576 having a receptacle ferrule receiver axis 576X, a receptacle block 577, a receptacle assembly housing 578, and a receptacle ferrule retainer 580.

[0163] The receptacle ferrule receiver 576 can receive an individual guide bundle ferrule 470 (shown in FIG. 4). The receptacle ferrule receiver 576 can be formed in a receptacle block 577 of the receptacle assembly 574. The multiple receptacle ferrule receivers 576 can be arranged in an array in any suitable distribution pattern (a linear pattern is shown in FIG. 5). Non-limiting and non-exclusive examples of distribution patterns include linear, circular, hexagonal, or any suitable geometric distribution pattern.

[0164] The receptacle ferrule receiver 576 may vary depending on the design requirements of the catheter system 500, the type, size, and / or configuration of the multiplexer 128 (shown in FIG. 1 ), the guide bundle 252 (shown in FIG. 1 ), and / or the alignment assembly 556. It is understood that the receptacle ferrule receiver 576 may include additional components, systems, subsystems, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the receptacle ferrule receiver 576 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, various components of the receptacle ferrule receiver 576 may be positioned differently than those specifically illustrated in FIG. 5. The receptacle ferrule receiver 576 may include an axial ferrule stopper.

[0165] The receptacle assembly housing 578 houses the individual components of the receptacle assembly 574, such as the receptacle ferrule receiver 576, the receptacle block 577, and the receptacle ferrule retainer 580. The receptacle assembly housing 578 may enable the receptacle assembly 574 to be coupled to the multiplexer 128. The receptacle assembly housing 578 may include guide pins 581 to guide the alignment, positioning, and / or coupling of the receptacle assembly housing 578 with the multiplexer 128. The receptacle assembly housing 578 may vary depending on the design requirements of the catheter system 500, the type, size, and / or configuration of the multiplexer 128 (shown in FIG. 1 ), the guide bundle 252 (shown in the figure), and / or the receptacle assembly 574. In some embodiments, the various components of the receptacle assembly housing 578 may be positioned differently than specifically shown in Figure 5. The receptacle assembly housing 578 may include a v-groove block.

[0166] The receptacle ferrule retainer 580 can selectively retain and / or lock any number of the individual guide bundle ferrules 470 in a desired position within the receptacle ferrule receiver 576. The receptacle ferrule retainer 580 can retain the individual guide bundle ferrules 470 in one or more positions within the receptacle ferrule receiver 576. The receptacle ferrule retainer 580 can vary depending on the design requirements of the catheter system 500, the type, size, and / or configuration of the multiplexer 128 (shown in FIG. 1 ), the guide bundle 252 (shown in the figure), and / or the receptacle assembly 574. It is understood that the receptacle ferrule retainer 580 can include additional components, systems, subsystems, and elements other than those specifically shown and / or described herein.

[0167] Additionally or alternatively, the receptacle ferrule retainer 580 may omit one or more of the components, systems, subsystems, and elements specifically illustrated and / or described herein. In some embodiments, various components of the receptacle ferrule retainer 580 may be positioned differently than specifically illustrated in FIG. 5. The receptacle ferrule retainer 580 may include a plurality of spring-loaded plunger ball springs 580S that hold and / or lock the corresponding respective guide bundle ferrules 470 in one or more positions. In some embodiments, the receptacle ferrule retainer 580 may include plunger ball spring bridges 580B each having a plunger ball spring 580S configured to selectively lock each of the guide bundle ferrules 470 in a desired position within the receptacle ferrule receiver 576.

[0168] 6 is a perspective view of a portion of an embodiment of a catheter system 600 including yet another embodiment of an alignment assembly 656 and a receptacle assembly 674. As shown in FIG. 6, the alignment assembly 656 can include a stationary base 657, a first stage 658, a second stage 660, a third stage 661, a plurality of rollers 663, a first mover 667, and a second mover 668. The receptacle assembly 674 can include a receptacle assembly housing 678. The alignment assembly 656, the stationary base 657, the first stage 658, the second stage 660, the third stage 661, the plurality of rollers 663, the first mover 667, the second mover 668, the receptacle assembly 674, and the receptacle assembly housing 678 can be substantially similar to their counterparts described in other embodiments herein.

[0169] In some embodiments, the first stage 658, the second stage 660, and the third stage 661 may be separate stages. In other embodiments, the first stage 658, the second stage 660, and the third stage 661 may be the same stage or may be combined to form one stage where the first stage 658, the second stage 660, and the third stage 661 move in concert. It is understood that the alignment assembly 656 may include any suitable number of stages to meet the design requirements of the catheter system 600 and / or the alignment assembly 656.

[0170] Each of the plurality of rollers 663 is configured to engage and / or roll one or more stages. For example, the rollers 663 can roll the first stage 658 along and / or about a suitable axis. The rollers 663 can include, as non-limiting and non-exclusive examples, roller bearings with grooved mating surfaces, slotted wheels, gears, and / or pinions.

[0171] In certain embodiments, the first mover 667 and the second mover 668 are separate movers. In other embodiments, the first mover 667 and the second mover 668 may be the same mover or may be configured to move the same component. It is understood that the alignment assembly 656 can include any suitable number of movers to meet the design requirements of the catheter system 600 and / or the alignment assembly 656.

[0172] The first mover 667 and / or the second mover 668 can move the first stage 658, the second stage 660, and / or the third stage 661 along any suitable axis. In other embodiments, the first mover 667 and / or the second mover 668 can move the first stage 658, the second stage 660, and / or the third stage 661 about any suitable axis. Suitable axes include the first axis 470X (shown in FIG. 4), the second axis 470Y (shown in FIG. 4), the third axis 470Z (shown in FIG. 4), the first axis of rotation 470P (shown in FIG. 4), the second axis of rotation 470Q (shown in FIG. 4), and the third axis of rotation 470R (shown in FIG. 4).

[0173] The first mover 667 and / or the second mover 668 may include a motor, an actuator, and / or a bearing. Bearings may be utilized within the mover to stabilize the movement performed by the mover.

[0174] 7 is a rear view of a portion of an embodiment of a catheter system 700 including an embodiment of an alignment assembly 756 and a receptacle assembly 774. As shown in FIG. 7, the alignment assembly 756 can include a stationary base 757, a first stage 758, a second stage 760, a third stage 761, a first mover 767, a second mover 768, and / or a third mover 769. In the embodiment shown in FIG. 7, the first mover 767 can move the first stage 758 about the first axis of rotation 470P (shown in FIG. 4). In other embodiments, the first mover 767 can move the receptacle assembly 774 about the first axis of rotation 470P. The second mover 768 can move the second stage 760 along the first axis 470Z (shown in FIG. 4). The third mover 769 can move the first stage 758 about a second axis of rotation 470Q (shown in FIG. 4).

[0175] 8 is a side view of a portion of an embodiment of a catheter system 800, including an embodiment of an alignment assembly 856 and a receptacle assembly 874. As shown in FIG. 8, the alignment assembly 856 can include a stationary base 857, a first stage 858, a second stage 860, a number of rollers 863, a first mover 867, a second mover 868, and / or a third mover 869.

[0176] The first stage 858 can include a first stage guide 858G. The first stage guide 858G can guide the movement of the first stage 858. For example, in one non-exclusive and non-limiting embodiment, the first stage guide 858G includes a groove that engages with the slot of the roller 863. The first stage guide 858G can guide the movement of the first stage 858 in any suitable direction, including the first axis 470X (shown in FIG. 4), the second axis 470Y (shown in FIG. 4), the third axis 470Z (shown in FIG. 4), the first rotation axis 470P (shown in FIG. 4), the second rotation axis 470Q (shown in FIG. 4), and the third rotation axis 470R (shown in FIG. 4).

[0177] The second stage 860 can include a second stage guide 860G that is substantially similar to the first stage guide 858G. The stages described herein can have any suitable number of stage guides. Non-limiting and non-exclusive examples of stage guides include grooves, tracks, ridges, seams, channels, and slits.

[0178] 9 is a top view of a portion of an embodiment of a catheter system 900, including an embodiment of an alignment assembly 956 and a receptacle assembly 974. As shown in FIG. 9, the alignment assembly 956 can include a stationary base 957, a first stage 958, a second stage 960, a third stage 961, a plurality of rollers 963, a first mover 967, and a second mover 968. The receptacle assembly 974 can include a receptacle assembly housing 978. The alignment assembly 956, the stationary base 957, the first stage 958, the second stage 960, the third stage 961, the plurality of rollers 963, the first mover 967, the second mover 968, the receptacle assembly 974, and the receptacle assembly housing 978 can be substantially similar to their counterparts described in other embodiments herein.

[0179] Figure 10 is a cross-sectional view of a portion of an embodiment of the catheter system 1000 taken along line 10-10 of Figure 6, including an embodiment of an alignment assembly 1056 and a receptacle assembly 1074. As shown in Figure 10, the alignment assembly 1056 can include a stationary base 1057, a first stage 1058, a second stage 1060, a third stage 1061, and a number of rollers 1063. The receptacle assembly 1074 can include a receptacle ferrule receiver 1076 and a receptacle assembly housing 1078. The alignment assembly 1056, the stationary base 1057, the first stage 1058, the second stage 1060, the third stage 1061, the plurality of rollers 1063, the receptacle assembly 1074, the receptacle ferrule receiver 1076, and the receptacle assembly housing 1078 may be substantially similar to their counterparts described in other embodiments herein.

[0180] 11 is a flow chart illustrating one embodiment of a method for aligning a light source within the catheter system 100 (shown in FIG. 1 ). It is understood that the method may include additional steps other than those specifically illustrated and / or described herein. Additionally or alternatively, the method may omit one or more of the steps specifically illustrated and / or described herein. The method for alignment may be implemented in the catheter system 100 or other systems and subsystems not specifically illustrated and / or described herein.

[0181] At step 1182, alignment hardware is initialized. As used herein, "alignment hardware" may include (by way of non-limiting and non-exclusive examples) camera 128c (shown in FIG. 1), lighting device, guide bundle 152 (e.g., shown in FIG. 1), alignment assembly 256 (shown in FIG. 2), stationary base 257 (shown in FIG. 2), first stage 258 (shown in FIG. 2), second stage 260 (shown in FIG. 2), second stage knob 262 (shown in FIG. 2), roller 263 (shown in FIG. 2), rotating cam 264 (shown in FIG. 2), one or more movers 266 (shown in FIG. 2), receptacle assembly 374 (shown in FIG. 3), receptacle ferrule receiver 376 (shown in FIG. 3), receptacle assembly housing 378 (shown in FIG. 3), and / or receptacle ferrule retainer 380 (shown in FIG. 3).

[0182] At step 1183, coarse alignment of the alignment hardware is performed. The coarse alignment may be performed in any suitable manner. One non-limiting, non-exclusive example of a method for performing the coarse alignment is shown in FIG. 12 and described in more detail herein. The coarse alignment of the alignment hardware may include adjusting the x position, height (y position), z position, tilt (pitch), roll, yaw, and / or any suitable position along or about any suitable axis of the alignment hardware using one or more movers and / or adjusters.

[0183] At step 1184, the alignment of the light guide and the light source is checked. In some embodiments, the alignment of the light guide and the light source can be checked using a camera and an illumination source (such as a light emitting diode). The camera can capture an image of the proximal end of the light guide. The system controller can generate an XYZ coordinate reference plane using the image captured by the camera.

[0184] The system controller can detect features of the proximal end of the light guide using one or more reference features from the reference image. The system controller can identify pixels in the captured image. In some embodiments, the system controller can detect features with sub-pixel pitch accuracy. Non-limiting and non-exclusive examples of features and reference features include a light guide end face, a light guide opening, a light guide receiver, a light guide energy dump, a light guide target, and / or a light guide core. The reference features from the reference image can include a wide range of variations in the image, including details such as exposure levels, image resolution, lighting variations, camera imperfections and artifacts, feature sizes, and / or image quality.

[0185] The system controller can calculate an acceptance region for each feature in comparison to a reference feature, and can then use the calculated acceptance regions to verify that the alignment is within a desired tolerance.

[0186] The light energy of the light source is tested at step 1185. In some embodiments, a laser is the light source and the power level of the laser is tested.

[0187] In step 1186, fine alignment of the alignment hardware is performed. The fine alignment may be performed in any suitable manner. In some embodiments, the fine alignment may be performed in some similar manner to the coarse alignment.

[0188] The alignment of the guide bundle is checked at step 1187. In some embodiments, the guide pins of the alignment assembly are checked for proper alignment with the guide bundle.

[0189] At step 1188, the alignment of the light guide and the light source is continuously monitored until treatment is completed. In some embodiments, the continuous monitoring of the alignment of the light guide and the light source may end upon completion of the method of aligning the light source within the catheter system.

[0190] 12 is a flow chart illustrating one embodiment of a method for performing coarse alignment of a light source in a catheter system, according to various embodiments herein. It is understood that the method may include additional steps other than those specifically illustrated and / or described herein. Additionally or alternatively, the method may omit one or more of the steps specifically illustrated and / or described herein. The method for alignment may be implemented in the catheter system or other systems and subsystems not specifically illustrated and / or described herein.

[0191] In step 1289, the control of the alignment hardware is initialized. The control initialization can include detecting light guide bundles and / or connectors, inspecting one or more system modules, powering up the system, installing one or more cameras, installing one or more illuminators, powering up one or more stages, and / or powering up the alignment hardware.

[0192] At step 1290, alignment data is loaded. The loaded alignment data may include one or more of hard-coded settings, calibration settings, parameters, alignment offsets, control settings, error codes, and / or image path settings. In some embodiments, the loaded alignment data may also include a plurality of light guide reference positions and / or a plurality of coordinates in a reference plane. The reference plane may include a 3D grid having a first axis, a second axis, and a third axis. In some embodiments, suitable axes in the reference plane include an x-axis, a y-axis, and a z-axis. The plurality of light guide reference positions may include a light guide end face reference position.

[0193] In step 1291, the alignment hardware is moved to a position. The positioning may include homing to the first stage. The positioning step may include importing a data dictionary and performing system error checking.

[0194] At step 1292, the alignment data is read. Once the alignment hardware is moved to the first position, the cameras can be utilized as machine vision to detect the first picture. One or more cameras can capture images taken at the first position. The cameras can continue to capture images until all reference targets are captured. If the targets are not fully captured, the stage can be moved to a second position, a third position, or any suitable number of positions until all reference targets are captured by the one or more cameras.

[0195] In step 1293, the image data is processed. Once all reference targets are captured by the one or more cameras, the system detects reference features. One or more image processing algorithms can process the image data. The image processing algorithms can utilize feature detection as described herein. The image processing algorithms can work with one or more evaluation matrices to improve the algorithm by training with a wide range of reference image data including exposure levels, image resolution, lighting variations, camera imperfections and artifacts, feature sizes, and / or image quality. In some embodiments, the evaluation matrices can include more than 600 data sets containing more than 10,000 images.

[0196] In step 1294, the system checks for and handles errors. If an error is detected in the system, the system is updated and the error is handled by the error handling. If no error is detected in the system, the method proceeds to step 1295.

[0197] In step 1295, the alignment tolerance is checked. The checking may include calculating one or more tolerance regions for each reference target of the feature. After the tolerance regions are calculated, the alignment is checked to determine that it is within the one or more tolerance regions.

[0198] In step 1296, the alignment data is verified. In this step, one or more alignment coordinates may be verified. Processing of the alignment data may include filtering, averaging, generating statistics, and any other suitable data processing. If there is a data validation error, the system is updated and the error is handled by error processing. Data validation errors may include errors in the system, false negatives, false positives, and feature and / or reference detection errors.

[0199] In step 1297, an alignment offset is determined. In this step, the alignment offset may be adjusted. The adjustment may include removing the camera offset. A linear regression may be performed to calculate one or more axis offset values. The one or more axis offset values ​​may include x-axis offset, y-axis offset, z-axis offset, pitch offset, tilt offset, yaw offset, and / or roll offset. If the coarse alignment is confirmed in step 1297, the method for the coarse alignment ends. If the coarse alignment is not within the tolerance range, the method repeats steps 1291-1296. After the offset determination is completed, the tolerance range may be checked for each individual feature. In some embodiments, the alignment adjustment may be confirmed with three or more retests.

[0200] 13 is a flow chart illustrating yet another embodiment of a method for performing coarse alignment of a light source 124 (shown in FIG. 1 ) in a catheter system (shown in FIG. 1 ), according to various embodiments herein. It is understood that the method may include additional steps other than those specifically illustrated and / or described herein. Additionally or alternatively, the method may omit one or more of the steps specifically illustrated and / or described herein. The method of FIG. 13 may be substantially similar to the method illustrated and described with respect to FIG. 12 , but may also include additional steps and sub-steps, as illustrated.

[0201] FIG. 14 is a view of an end face of light guide 122A (shown in FIG. 1) captured by camera 128c (shown in FIG. 1) during one embodiment of a method for aligning a light source within a catheter system.

[0202] FIG. 15 is another view of the end face of light guide 122A (shown in FIG. 1) captured by camera 128c (shown in FIG. 1) during one embodiment of a method for aligning a light source within a catheter system.

[0203] FIG. 16 is yet another view of an end face of light guide 122A (shown in FIG. 1) captured by camera 128c (shown in FIG. 1) during one embodiment of a method for aligning a light source within a catheter system.

[0204] FIG. 17 is yet another view of an end face of light guide 122A (shown in FIG. 1) captured by camera 128c (shown in FIG. 1) during one embodiment of a method for aligning a light source within a catheter system.

[0205] FIG. 18 is an illustration of a user interface displaying an overlay coordinate plane used during one embodiment of a method for aligning a light source within a catheter system.

[0206] As described in detail herein, in various embodiments, alignment assemblies and receptacle assemblies can be utilized to solve many of the problems present in more traditional catheter systems. For example,

[0207] 1) In some embodiments, the technology allows for micrometer-level correction of the positioning of wires connecting lightguides in a lightguide array using low-cost components with low resolution of movement, low precision, and small tolerances in mechanical dimensions and movements. This is achieved by using adjusters and / or movers that include knobs and cams that are far enough away from the positions of the lightguides whose positions are to be corrected.

[0208] 2) The alignment and receptacle assemblies can be mounted in any suitable orientation. In some embodiments, the axial direction (of the light guides and source beam) determines the alignment of the connector placement with the focal line of the beam, and such a mechanism can be moved in sync with the multiplexer / beam scanner such that each light guide is positioned at the desired focal distance from the coupling optic.

[0209] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content and / or context clearly dictates otherwise. It should also be noted that the term "or" is generally used in its sense including "and / or" unless the content or context clearly dictates otherwise.

[0210] It should also be noted that, as used herein and in the appended claims, the phrase "configured" describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases such as arranged and configured, built and arranged, constructed, manufactured and arranged, etc.

[0211] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or to otherwise provide an organizational cue. These headings should not be considered to limit or characterize the invention(s) recited in any claimed patent that may be issued from this disclosure. As an example, a description of a technology in the "Background" is not an admission that the technology is prior art to any invention(s) in this disclosure. Neither the "Summary" nor the "Abstract" should be considered a feature of the invention(s) recited in the issued claims.

[0212] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that those skilled in the art can appreciate and understand the principles and practices. Thus, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the description.

[0213] Although several different embodiments of the catheter system have been illustrated and described herein, it should be understood that one or more features of any one embodiment may be combined with one or more features of one or more of the other embodiments, provided such combination meets the intent of the invention.

[0214] While several exemplary aspects and embodiments of the catheter system have been described above, those skilled in the art will recognize certain modifications, permutations, additions, and subcombinations thereof, and therefore, the following appended claims and claims introduced below are intended to be construed to include all such modifications, permutations, additions, and subcombinations as are within their true spirit and scope, and are not intended to limit the details of construction or design shown herein.

Claims

1. 1. A catheter system for treating a vascular lesion in or adjacent to a blood vessel wall within a patient's body, the catheter system comprising: a light source generating a light source beam of light energy; a receptacle assembly; a first light guide and a second light guide coupled to the receptacle assembly, each light guide having a guide proximal end; a multiplexer that receives the light source beam from the light source, the multiplexer directing individual guide beams from the light source beam to each of the guide proximal end of the first light guide and the guide proximal end of the second light guide; an alignment assembly for adjusting the position of the receptacle assembly relative to the individual guide beams; A catheter system comprising:

2. The catheter system of claim 1 , wherein the proximal guide end of the first light guide and the proximal guide end of the second light guide each have two rotational degrees of freedom.

3. The catheter system of claim 1 or 2, wherein the receptacle assembly has three degrees of freedom.

4. The catheter system of claim 1 or 2, wherein the receptacle assembly has three rotational degrees of freedom.

5. The catheter system of claim 1 or 2, wherein the multiplexer has at least one degree of freedom.

6. 3. The catheter system of claim 1, wherein the alignment assembly adjusts the receptacle assembly relative to the individual guide beams with micrometer-level adjustment.

7. The catheter system of claim 1 or 2, wherein the alignment assembly adjusts the receptacle assembly relative to the multiplexer.

8. The catheter system of claim 1 or 2, wherein the receptacle assembly is coupled to the alignment assembly.

9. The catheter system of claim 1 or 2, wherein the multiplexer is coupled to the alignment assembly.

10. 3. The catheter system of claim 1, wherein the alignment assembly includes a camera that captures an image of the proximal guide end of each light guide so that alignment of the individual guide beams relative to the proximal guide end can be adjusted.

11. 1. A catheter system for treating vascular lesions in or adjacent to a blood vessel wall within a patient's body, the catheter system comprising: a light source generating a light source beam of light energy; a receptacle assembly; a first light guide and a second light guide coupled to the receptacle assembly, each light guide having a guide proximal end; and a multiplexer receiving the light source beam from the light source, the multiplexer directing individual guide beams from the light source beam to each of the guide proximal end of the first light guide and the guide proximal end of the second light guide, the catheter system comprising: an alignment assembly for adjusting the position of the receptacle assembly relative to the individual guide beams; A catheter system comprising:

12. The catheter system of claim 11 , wherein the alignment assembly includes a camera that captures an image of the proximal guide end of each light guide so that alignment of the individual guide beams relative to the proximal guide end can be adjusted.

13. 13. The catheter system of claim 11 or 12, wherein the alignment assembly includes a first stage selectively secured to the receptacle assembly and a second stage selectively secured to the first stage, the first stage configured to rotate about one of a first axis and a second axis, and the second stage configured to raise and lower the first stage on the first axis.

14. A catheter system as described in claim 13, wherein the alignment assembly includes a second stage knob that engages with a second rotating cam, the second rotating cam being coupled to a second movable element, the second movable element driving the second rotating cam such that the second stage raises and lowers the first stage on the first axis.

15. 1. A method for positioning a light source in a catheter system for treating a vascular lesion in or adjacent to a blood vessel wall within a patient's body, the catheter system including a single light source that generates light energy, the method comprising: Initiating control of a plurality of pieces of hardware of the catheter system, the plurality of pieces of hardware including at least one of: (i) a light guide configured to selectively receive light energy from the light source; (ii) a camera that captures the alignment of the light source within the light guide; and (iii) a mover configured to selectively adjust the positioning of the light source within the light guide; performing a coarse alignment of the positioning of the light source within the light guide; Inspecting at least one of (i) the alignment of the light source within the light guide, and (ii) the light energy level of the light source; performing precision alignment of the positioning of the light source within the light guide; A method comprising:

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