Optical electrical connector for intravascular lithotripsy device.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-08-04
- Publication Date
- 2026-03-13
AI Technical Summary
Existing treatments for vascular lesions, such as severely calcified lesions, are difficult to perform effectively and consistently, posing a risk of major adverse events and requiring subsequent interventions.
A catheter system with an optical-electrical connector that aligns energy guides with an energy source, allowing precise delivery of energy to generate plasma and pressure waves for treating vascular lesions, featuring a guide coupling housing, electrical connectors, and a sealing mechanism to ensure consistent and controlled treatment.
Enhances vascular patency by effectively treating lesions with controlled energy delivery, reducing the risk of adverse events and optimizing treatment parameters.
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Abstract
Description
[Technical Field]
[0001] This application is related to and claims priority to U.S. Provisional Patent Application No. 63 / 395,853, entitled "OPTOELECTRICAL CONNECTOR FOR INTRAVASCULAR LITHOTRIPSY DEVICE," filed August 7, 2022, and U.S. Patent Application No. 18 / 365,101, entitled "OPTOELECTRICAL CONNECTOR FOR INTRAVASCULAR LITHOTRIPSY DEVICE," filed August 3, 2023. To the extent permitted, the contents of U.S. Patent Application Nos. 63 / 395,853 and 18 / 365,101 are incorporated herein by reference in their entireties. [Background technology]
[0002] Vascular lesions in blood vessels within the body can be associated with an increased risk of major adverse events such as myocardial infarction, embolism, deep vein embolism, stroke, etc. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult for physicians to treat and achieve patency in a clinical setting.
[0003] Vascular lesions may be treated using treatments such as drug therapy, balloon angioplasty, atherectomy, stenting, vascular graft bypass surgery, to name a few, but such treatments may not always be ideal or may require subsequent treatment to address the lesion.
[0004] Intravascular lithotripsy is a method that has been used with some success in recent years to destroy vascular lesions within blood vessels within the body. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics generated within a fluid-filled balloon catheter. Specifically, during an intravascular lithotripsy treatment, a high-energy source is used to generate plasma within the fluid-filled balloon, ultimately generating pressure waves and rapid bubble expansion, to destroy calcifications at a treatment site within the vasculature, including one or more vascular lesions. Plasma initiation within the balloon and the associated rapid bubble formation from the resulting localized flow velocity transfer mechanical energy through the incompressible fluid, exerting a disruptive force on intravascular calcium opposed to the balloon wall. The rapid change in fluid momentum upon impact with the balloon wall is known as hydraulic shock, or water hammer.
[0005] There is a continuing desire to enhance vascular patency and optimize treatment delivery parameters within intravascular lithotripsy catheter systems in a format that is relatively easy to control and can be consistently manufactured. Summary of the Invention [Means for solving the problem]
[0006] The present invention relates to a catheter system for treating a treatment site within or adjacent to a blood vessel in a patient's body. In various embodiments, the catheter system includes a catheter, a system console, an energy source, one or more energy guides, and an optical / electrical connector. The system console includes a console connection opening. The energy source is configured to generate energy. The one or more energy guides are configured to receive energy from the energy source. The optical / electrical connector is coupled to the catheter. The optical / electrical connector includes a guide coupling housing that holds at least a portion of each of the one or more energy guides. The guide coupling housing is configured to be selectively mechanically connected to the system console, and at least a portion of the guide coupling housing is configured to mate with and be selectively retained within the console connection opening such that the one or more energy guides are adjustably aligned with respect to energy from the energy source within the guide coupling housing to receive energy from the energy source. The optical-electrical connector also includes at least a portion of an electrical connector assembly positioned adjacent to the guide coupling housing and transmitting at least one of power and data between the system console and the catheter when the guide coupling housing is held within the console connection opening.
[0007] In many embodiments, the electrical connection assembly includes a first electrical connector disposed within the system console and a second electrical connector disposed adjacent to the guide coupling housing, the second electrical connector configured to mate with the first electrical connector when the guide coupling housing is retained within the console coupling opening.
[0008] In some embodiments, the second electrical connector includes a connector base and a plurality of electrical connection pads connected to the connector base.
[0009] In some embodiments, the electrical connection assembly further includes an electrical cable electrically connected to the second electrical connector and the catheter.
[0010] In some embodiments, the energy source is located within the system console.
[0011] In certain embodiments, the optical-electrical connector further includes: (i) a plurality of ferrules, each of the plurality of ferrules configured to hold a portion of one of the one or more energy guides; and (ii) a ferrule housing having a plurality of locating openings, each of the ferrules configured to hold at least a portion of one of the plurality of spaced-apart ferrules. In some embodiments, each of the plurality of locating openings is larger than a diameter of a ferrule to be held therein, such that the ferrule can move relative to the locating opening.
[0012] In some embodiments, the ferrule housing is adjustably disposed within the guide coupling housing such that the ferrule housing is movable relative to the guide coupling housing.
[0013] In one embodiment, the guide coupling housing includes a console-facing side, and the plurality of ferrules are recessed from the console-facing side of the guide coupling housing.
[0014] In some embodiments, the optical-electrical connector further includes a sealing member that seals the connection between the guide coupling housing and the console connection opening.
[0015] In one embodiment, the optical-electrical connector further includes a contaminant inhibitor positionable around at least a portion of the guide coupling housing, the contaminant inhibitor configured to prevent dust and particles from contaminating respective surfaces of the one or more energy guides.
[0016] In certain embodiments, the optical-electrical connector further includes a locking mechanism configured to selectively lock the guide coupling housing in place when the guide coupling housing is retained within the console connection opening.
[0017] In some embodiments, the system console further includes an optical sensor and an actuator. In one embodiment, the optical sensor is configured to sense a position of the guide coupling housing relative to the console connection opening and is further configured to activate an actuator that mechanically draws the guide coupling housing into a predetermined position within the console connection opening.
[0018] In many embodiments, the catheter system further includes a balloon configured to be positioned substantially adjacent to the treatment site. The balloon includes a balloon wall defining a balloon interior. The balloon is configured to hold a catheter fluid within the balloon interior. In some embodiments, each of the one or more energy guides includes a guide distal end configured to be positioned within the balloon interior. Each of the one or more energy guides is configured to guide energy from an energy source through the energy guide to the balloon interior. In some embodiments, each of the one or more energy guides that guide energy from the energy source to the balloon interior generates a plasma in the catheter fluid within the balloon.
[0019] In various embodiments, at least one of the one or more energy guides includes an optical fiber and the energy source includes a laser.
[0020] the one or more energy guides are adjustably aligned with the energy source within the guide coupling housing; and transmitting at least one of power and data between the system console and the catheter via the electrical connector assembly when the guide coupling housing is held within the console connection opening.
[0021] The present invention provides a catheter system for treating a treatment site within or adjacent to a blood vessel in a patient's body, the catheter system comprising: a catheter; a system console including a console connection opening, an optical sensor, and an actuator; an energy source configured to generate energy; one or more energy guides configured to receive energy from the energy source; and an optical electrical connector coupled to the catheter, the optical electrical connector including: (i) a guide coupling housing for holding at least a portion of each of the one or more energy guides, the guide coupling housing configured to be selectively mechanically connected to the system console, at least a portion of the guide coupling housing configured to mate with and be selectively held within the console connection opening such that the one or more energy guides are adjustably aligned with respect to energy from the energy source within the guide coupling housing to receive energy from the energy source; and an optical sensor configured to sense the position of the guide coupling housing relative to the console connection opening. (ii) at least a portion of an electrical connector assembly disposed adjacent to the guide coupling housing and configured to transmit at least one of power and data between the system console and the catheter when the guide coupling housing is held within the console connection opening, the electrical connector assembly including a first electrical connector disposed within the system console and a second electrical connector disposed adjacent to the guide coupling housing, the second electrical connector configured to couple with the first electrical connector when the guide coupling housing is held within the console connection opening, the second electrical connector including a connector base and a plurality of electrical connection pads coupled to the connector base; and (iii) a plurality of ferrules, each of the plurality of ferrules configured to hold a portion of one of the one or more energy guides.(iv) a ferrule housing having a plurality of locating openings, each configured to hold at least a portion of one of a plurality of ferrules spaced apart from one another, each of the plurality of locating openings being larger than a diameter of a ferrule held therein to allow the ferrule to move relative to the locating opening, the ferrule housing being adjustably disposed within the guide coupling housing such that the ferrule housing is movable relative to the guide coupling housing; The present invention also relates to a catheter system comprising an optical-electrical connector including the optical connector.
[0022] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or comprehensive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will become 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 is not to be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.
[0023] The novel features of this invention, and the invention itself, both as to its structure and operation, can best be understood from the accompanying drawings taken in conjunction with the accompanying description, in which like reference numerals refer to like parts. [Brief explanation of the drawings]
[0024] [Figure 1] 1 is a simplified schematic cross-sectional view of an embodiment of a catheter system according to various embodiments. [Figure 2] FIG. 2 is a simplified perspective view of an embodiment of an optical-electrical connector assembly having features of the present invention that may be included as part of the catheter system of FIG. 1. [Figure 3] FIG. 3 is a simplified plan view of a portion of the optical-electrical connector assembly shown in FIG. 2. [Figure 4]FIG. 3 is a simplified bottom view of the optical-electrical connector assembly shown in FIG. 2. [Figure 5] FIG. 3 is a simplified end view of the optical-electrical connector assembly shown in FIG. 2. [Figure 6] FIG. 10 is a simplified plan view of a portion of another embodiment of an optical-electrical connector assembly. [Figure 7A] FIG. 10 is a simplified top perspective view of a portion of yet another embodiment of an optical-electrical connector assembly. [Figure 7B] FIG. 7B is a simplified bottom view of a portion of the optical-electrical connector assembly shown in FIG. 7A. DETAILED DESCRIPTION OF THE INVENTION
[0025] While embodiments of the present invention are susceptible to various modifications and alternative forms, 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 present invention is not limited to the particular embodiments described. On the contrary, the invention covers modifications, equivalents, and alternatives falling within the spirit and scope of the present invention.
[0026] Treatment of vascular lesions can reduce major adverse events or death in affected subjects. As referred to herein, a major adverse event can occur anywhere in the body due to the presence of a vascular lesion. Major adverse events can include, but are not limited to, major cardiac adverse events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in muscle tissue, or major adverse events in any of the internal organs.
[0027] In various embodiments, the catheter systems and related methods disclosed herein can include a catheter configured to advance to a vascular lesion, such as a calcified vascular lesion or a fibrovascular lesion, at a treatment site located within or adjacent to a blood vessel within a patient's body. As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably unless otherwise noted. Thus, an intravascular lesion and / or a vascular lesion is sometimes referred to herein simply as a "lesion."
[0028] Those skilled in the art will understand that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to those skilled in the art having the benefit of this disclosure. Reference will now be made in detail to the embodiments of the present invention that are illustrated in the accompanying drawings. The same or similar nomenclature and / or reference numerals are used throughout the drawings and the following detailed description to refer to the same or similar parts.
[0029] In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will be recognized that in developing any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's particular objectives, such as compliance with application-related and business-related constraints, and that these particular objectives will vary from implementation to implementation and from developer to developer. Moreover, it will be recognized that such a development effort might 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.
[0030] The catheter systems disclosed herein can include many different configurations. Referring now to FIG. 1 , a simplified 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 fracture in one or more vascular lesions within or adjacent to a vessel wall of a blood vessel or at or adjacent to a heart valve within a patient's body. In the embodiment shown in FIG. 1 , the catheter system 100 can include one or more of a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a source manifold 136, a fluid pump 138, a system console 123 including one or more of an energy source 124, a power supply 125, a system controller 126, and a graphic user interface 127 ("GUI"), and a handle assembly 128. In various embodiments, the catheter system 100 further includes an optical-electrical connector assembly 151 (also referred to herein as an "optical-electrical connector") configured to transmit at least one of power and data between the system console 123 and the catheter 102 and ensure desired optical communication between the energy source 124 and one or more energy guides 122A of the energy guide bundle 122. Various embodiments of the optical-electrical connector 151 are described in more detail herein below. Alternatively, the catheter system 100 may include more or fewer components than those specifically illustrated and described with respect to FIG. 1 .
[0031] 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 within the body 107 of a patient 109. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 may include a vascular lesion 106A, such as a fibrovascular lesion. Further alternatively, in some embodiments, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve within the body 107 of the patient 109.
[0032] The catheter 102 may include an inflatable balloon 104 (sometimes referred to herein 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 102 and / or the catheter shaft 110 may also include a guidewire lumen 118 configured to travel over the guidewire 112. As used 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 that can accommodate and follow 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.
[0033] The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a catheter fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through a patient's vasculature to an inflated state (shown in FIG. 1 ) suitable for securing the catheter 102 in place relative to the treatment site 106. In other words, when the balloon 104 is in the inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It should be appreciated that while FIG. 1 shows the balloon wall 130 of the balloon 104 spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, this is done for ease of illustration. It should be appreciated that the balloon wall 130 of the balloon 104 will generally be substantially directly adjacent and / or adjacent to the treatment site 106 when the balloon 104 is in the inflated state.
[0034] Balloons 104 suitable for use in catheter system 100 include those that, when in an inflated state, can be passed through the vascular system of a patient 109. In some embodiments, balloon 104 is formed from silicone. In other embodiments, balloon 104 can be formed from materials such as polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX™ material, nylon, or any other suitable material.
[0035] 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. Alternatively, the balloon 104 can have another suitable diameter (in an inflated state).
[0036] In various non-exclusive alternative embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm, which can be selected based on the size and / or length of the vascular lesion 106A at the treatment site 106.
[0037] The balloon 104 may be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. Alternatively, the balloon 104 may be inflated to other suitable inflation pressures.
[0038] The balloon 104 can have a variety of shapes, including, but not limited to, conical, square, rectangular, spherical, conical / square, conical / spherical, elongated spherical, elliptical, tapered, bone, stepped diameter, offset, or conical offset. 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-tumor agents, angiogenesis inhibitors, etc.
[0039] The catheter fluid 132 can be a liquid or a gas. Some examples of catheter fluids 132 suitable for use include, but are not limited to, one or more of water, saline, contrast media, gases such as fluorocarbons, perfluorocarbons, carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 can be used as a base inflation fluid. In some embodiments, the catheter fluid 132 can include a mixture of saline and contrast media in a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 can include a mixture of saline and contrast media in a volume ratio of approximately 25:75. In yet other embodiments, the catheter fluid 132 can include a mixture of saline and contrast media in a volume ratio of approximately 75:25. However, it should be understood that any suitable ratio of saline to contrast media can be used. The catheter fluid 132 can be adjusted based on its composition, viscosity, etc., to appropriately manipulate the speed of travel of the pressure wave. In certain embodiments, the catheter fluid 132 suitable for use is biocompatible. The volume of catheter fluid 132 can be adjusted depending on the energy source 124 selected and the type of catheter fluid 132 used.
[0040] In some embodiments, the contrast agent used in the contrast medium can include, but is not limited to, an iodinated contrast agent, such as an ionic or non-ionic iodinated contrast agent, while in other embodiments, a non-iodinated contrast agent can be used.
[0041] The catheter fluid 132 can include a catheter fluid containing an absorber 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) region of the electromagnetic spectrum. Alternatively, the catheter fluid 132 can include a catheter fluid containing an absorber 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 μm) region of the electromagnetic spectrum. In various embodiments, the absorber can be an absorber having an absorption maximum that coincides with the emission maximum of a laser used in the catheter system 100. By way of non-limiting example, various lasers that can be used in catheter system 100 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 can be water-soluble. In other embodiments, the absorber is water-insoluble. In some embodiments, the absorber used in catheter fluid 132 can be tailored to match the peak emission of energy source 124.
[0042] The catheter shaft 110 of the catheter 102 can be coupled to one or more energy guides 122A of the energy guide bundle 122, which are in optical communication with the energy source 124 via an optical-electrical connector 151. The energy guides 122A can be disposed along the catheter shaft 110 and within the balloon 104. In some embodiments, each energy guide 122A can be an optical fiber and the energy source 124 can be a laser. The energy source 124 can be in optical communication with the energy guides 122A at a proximal portion 114 of the catheter system 100, such as where the energy guides 122A are selectively mechanically coupled to a system console 123 via the optical-electrical connector 151.
[0043] In some embodiments, the catheter shaft 110 may be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which may be positioned at any suitable location around and / or relative to the guidewire lumen 118 and / or catheter shaft 110. In certain non-exclusive embodiments, the catheter shaft 110 may be coupled to two energy guides 122A, three energy guides 122A, four energy guides 122A, five energy guides 122A, six energy guides 122A, eight energy guides 122A, or ten energy guides 122A, which may be uniformly spaced from one another around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Alternatively, the multiple energy guides 122A need not be equally spaced from one another around the circumference of the guidewire lumen 118 and / or catheter shaft 110. More specifically, it should be further appreciated that the energy guide 122A can be evenly or unevenly positioned around the guidewire lumen 118 and / or catheter shaft 110 to achieve the desired effect at the desired location.
[0044] The catheter system 100 and / or the energy guide bundle 122 can include any number of energy guides 122A in optical communication (via optical-electrical connectors 151) with the energy source 124 at the proximal portion 114 and with the catheter fluid 132 within the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or the energy guide bundle 122 can include from 1 energy guide 122A to 30 energy guides 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy guide bundle 122 can include more than 30 energy guides 122A.
[0045] The energy guide 122A can have any suitable design for generating plasma and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Accordingly, the general description of the energy guide 122A as a light guide is not intended to be limiting in any way, except as set forth in the claims appended hereto. More specifically, although the catheter system 100 is often described with reference to the energy source 124 as a light source and one or more energy guides 122A as light guides, the catheter system 100 can alternatively include any suitable energy source 124 and energy guides 122A for generating the desired plasma in the catheter fluid 132 within the balloon interior 146. For example, in one non-exclusive alternative embodiment, the energy source 124 can be configured to provide high-voltage pulses, and each energy guide 122A can include an electrode pair including spaced-apart electrodes extending into the balloon interior 146. In such an embodiment, pulses of high voltage are applied to the electrodes, forming an electric arc between the electrodes, which in turn generates a plasma, creating pressure waves in the catheter fluid 132, which are utilized to provide a disruptive force to the vascular lesion 106A at the treatment site 106. Further alternatively, the energy source 124 and / or energy guide 122A can have another suitable design and / or configuration.
[0046] In certain embodiments, the energy guide 122A may comprise an optical fiber or a flexible light pipe. The energy guide 122A may be thin and flexible and may transmit optical signals with minimal loss of intensity. The energy guide 122A may comprise a core surrounded by a cladding along its periphery. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the energy 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 energy guide 122A may also include a protective coating, such as a polymer. It should be appreciated that the refractive index of the core is greater than the refractive index of the cladding.
[0047] Each energy guide 122A can guide energy along its length from a guide proximal end 122P to a guide distal end 122D having at least one optical window (not shown) disposed within the balloon interior 146.
[0048] The energy guide 122A can have many configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be positioned along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy guide 122A can be positioned within one or more energy guide lumens within the catheter shaft 110.
[0049] The energy guides 122A can be positioned at any suitable position along the guidewire lumen 118 and / or the catheter shaft 110, and the guide distal end 122D of each energy guide 122A can be positioned at any suitable longitudinal position relative to the length of the balloon 104 and / or the length of the guidewire lumen 118 to more effectively and accurately deliver pressure waves to destroy the vascular lesion 106A at the treatment site 106.
[0050] In certain embodiments, the energy guide 122A can include one or more optoacoustic transducers 154, each of which can be in optical communication with the energy guide 122A in which it is disposed. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the distal guide end 122D of the energy guide 122A. In such embodiments, the optoacoustic transducers 154 can have a shape that corresponds to and / or matches the distal guide end 122D of the energy guide 122A.
[0051] The photoacoustic transducer 154 is configured to convert light energy into acoustic waves at or near the distal guide end 122D of the energy guide 122A, and the direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the energy guide 122A.
[0052] In certain embodiments, the optoacoustic transducer 154 disposed at the distal guide end 122D of the energy guide 122A can have the same shape as the distal guide end 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the optoacoustic transducer 154 and / or the distal guide 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 energy guide 122A can further include additional optoacoustic transducers 154 disposed along one or more sides of the length of the energy guide 122A.
[0053] In some embodiments, the energy guide 122A can further include one or more deflecting structures or “diverters” (not shown in FIG. 1 ), such as within the energy guide 122A and / or near the guide distal end 122D of the energy guide 122A. Such deflecting structures can be configured to direct energy away from the energy guide 122A and toward a side surface, which can be located at or near the guide distal end 122D of the energy guide 122A, before the energy is directed toward the balloon wall 130. The energy guides 122A can each include one or more optical windows located along a longitudinal or circumferential surface of each energy guide 122A and in optical communication with the deflecting structures. The optical windows can include portions of the energy guide 122A that allow energy from within the energy guide 122A to exit the energy guide 122A, such as a portion of the energy guide 122A that lacks cladding material on or around the energy guide 122A.
[0054] Examples of deflecting structures suitable for use include reflective elements, refractive elements, and fiber diffusers. Deflecting structures suitable for focusing energy away from the tip of the energy guide 122A can include, but are not limited to, those having a convex surface, a gradient index (GRIN) lens, or a mirror-focus lens. Upon contact with the deflecting structure, energy is diverted within the energy guide 122A to one or more of the plasma generator 133 and the optoacoustic transducer 154, which is in optical communication with the side and / or optical window of the energy guide 122A.
[0055] The source manifold 136 can be located at or near the proximal portion 114 of the catheter system 100. The source manifold 136 can include one or more proximal end openings that can receive the plurality of energy guides 122A of the energy guide bundle 122, the guidewire 112, and / or an inflation conduit 140 coupled in fluid communication with a fluid pump 138. The catheter system 100 can also include a fluid pump 138 configured to inflate the balloon 104 with catheter fluid 132 as needed.
[0056] As noted above, in the embodiment shown in FIG. 1 , the system console 123 includes one or more of the energy source 124, the power supply 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically shown in FIG. 1 . For example, in one non-exclusive alternative embodiment, the system console 123 may be designed without the GUI 127. Further alternatively, one or more of the energy source 124, the power supply 125, the system controller 126, and the GUI 127 may be provided in any suitable location within the catheter system 100, without the specific need for a system console 123.
[0057] As shown, the system console 123 and the components included therewith are operably coupled to the catheter 102, the energy 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 also commonly referred to as a “socket” or “console receptacle”) by which the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 can include and / or incorporate an optical-electrical connector 151 having a guide coupling housing 150 (sometimes also commonly referred to as a “connector housing”) that houses a portion of each energy guide 122A, such as the guide proximal end 122P. At least a portion of the guide coupling housing 150 is configured to mate with and be selectively retained within the console connection opening 148 to provide a mechanical coupling between the energy guide bundle 122 and the system console 123.
[0058] As described in more detail herein below, in various embodiments, the optical-electrical connector 151 is configured to ensure proper alignment and coupling of the energy guide bundle 122 and / or each of the one or more energy guides 122A to the system console 123 so that energy from the energy source 124 may be more precisely and accurately directed into the proximal guide end 122P of each of the one or more energy guides 122A before such energy is guided by the one or more energy guides 122A to the balloon interior 146. In certain embodiments, the system console 123 may also be configured to include certain features or components, such as at least one optical sensor 167 (shown in phantom) usable in association with at least one actuator 169 (shown in phantom) that further enable precise alignment and coupling of the energy bundle 122 and / or each of the one or more energy guides 122A to the energy from the system console 123 and / or the energy source 124 held therein.
[0059] As will be described in more detail herein below, in many embodiments, the optical-electrical connector 151 is further configured to ensure proper electrical connection between the system console 123, and thus the power source 125, and various other components of the catheter system 100. More specifically, in some embodiments, the system console 123 may include a first electrical connector 163 (shown in phantom) configured to mate with a second electrical connector 465 (e.g., shown in FIG. 4 ) disposed within and / or adjacent to the guide coupling housing 150 and / or incorporated within the optical-electrical connector 151 to ensure effective transmission of power and data between the system console 123 and the catheter 102. As referred to herein, the first electrical connector 163 and the second electrical connector 465 may sometimes be individually and / or collectively referred to herein as an “electrical connection assembly.” In some embodiments, the electrical connection assembly can also include an electrical cable 386 (shown in FIG. 3) that can be coupled to a second electrical connector 465 to further enhance the transmission of power and data between the system console 123 and various other components of the catheter system 100.
[0060] It should be appreciated that the designation of the first electrical connector 163 and the second electrical connector 465 as part of the electrical connection assembly is merely for convenience, and either electrical connector may be referred to as the "first electrical connector" and / or the "second electrical connector."
[0061] The energy guide bundle 122 and / or the optical-electrical connector 151 may also include a guide bundler 152 (or "shell") that provides strain relief while bringing each of the individual energy guides 122A closer together so that the energy guides 122A and / or the energy guide bundle 122 can assume a more compact form when extended into the blood vessel 108 with the catheter 102 during use of the catheter system 100.
[0062] The energy source 124 can be selectively and / or alternatively coupled in optical communication with each energy guide 122A in the energy guide bundle 122, such as to the guide proximal end 122P of each energy guide 122A. In particular, the energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, that can be selectively and / or alternatively directed and received by each appropriately aligned energy guide 122A in the energy guide bundle 122 as an individual guide beam 124B. Alternatively, the catheter system 100 can include two or more energy sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate energy source 124 for each energy guide 122A in the energy guide bundle 122.
[0063] The energy source 124 can have any suitable design. In one embodiment, the energy source 124 can be configured to provide sub-millisecond pulses of energy from the energy source 124 that are focused to a small spot for coupling to the proximal guide end 122P of the energy guide 122A. These pulses of energy are then directed and / or guided along the energy guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the catheter fluid 132 within the balloon interior 146 of the balloon 104, such as via a plasma generator 133 that can be located at or near the distal guide end 122D of the energy guide 122A. In particular, the energy emitted at the distal guide end 122D of the energy guide 122A is directed toward, impinges on, and excites the plasma generator 133 to form plasma in the catheter fluid 132 within the balloon interior 146. The plasma formation results in rapid bubble formation, providing a pressure wave to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.
[0064] In various non-exclusive alternative embodiments, sub-millisecond pulses of energy from energy source 124 can be delivered to 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 energy can be delivered to treatment site 106 at frequencies that may be greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.
[0065] While energy source 124 is generally utilized to provide pulses of energy, it should be appreciated that energy source 124 may further be described as providing a single source beam 124A, such as a single pulsed source beam.
[0066] Suitable energy sources 124 for use may include various types of light sources, including lasers and lamps. Alternatively, the energy source 124 may include any suitable type of energy source.
[0067] Suitable lasers include short-pulse lasers on the sub-millisecond timescale. In some embodiments, the energy source 124 can include a laser on the nanosecond (ns) timescale. Lasers can also include short-pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (μs) timescales. It should be appreciated that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be used to obtain a plasma in the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, pulse widths can include those included in 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.
[0068] 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, the energy source 124 suitable for use in the catheter system 100 can include those capable of generating light at wavelengths from at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include those capable of generating light at wavelengths from at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 can include those capable of generating light at wavelengths from at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having repetition rates of up to 200 kHz.
[0069] In some embodiments, the laser can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser, hi other embodiments, the laser can 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.
[0070] In yet other embodiments, the energy source 124 can include multiple lasers grouped in series. In yet other embodiments, the energy source 124 can include one or more low-energy lasers feeding into a high-energy amplifier, such as a master oscillator power amplifier (MOPA). In yet other embodiments, the energy source 124 can include multiple lasers that can be combined in parallel or series to provide the energy needed to generate plasma bubbles 134 in the catheter fluid 132.
[0071] The catheter system 100 can generate pressure waves having maximum pressures ranging from at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 depends on the energy source 124, the absorber 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 maximum pressures ranging from 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.
[0072] The pressure waves can be provided to 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 positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be provided to 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 positioned at the treatment site 106. In other embodiments, the pressure waves can be provided to the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure waves can be provided to the treatment site 106 at a distance of at least about 0.1 mm to 10 mm, within a range of at least about 2 MPa to 30 MPa. In some embodiments, pressure waves can be provided to the treatment site 106 from a range of at least about 2 MPa to 25 MPa over a distance of at least about 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances can be used.
[0073] Power supply 125 is electrically coupled to and configured to provide the necessary power to each of energy source 124, system controller 126, GUI 127, and handle assembly 128. Power supply 125 may have any suitable design for such purposes.
[0074] System controller 126 is electrically coupled to and receives power from power source 125. System controller 126 is coupled to each of energy source 124 and GUI 127 and configured to control their operation. System controller 126 may include one or more processors or circuitry for controlling the operation of at least energy source 124 and GUI 127. For example, system controller 126 may control energy source 124 to generate pulses of energy as needed and / or at any desired firing rate.
[0075] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as positioning the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with catheter fluid 132, etc. Additionally or alternatively, the catheter system 100 may include one or more additional controllers, which may be arranged in any suitable manner to control various operations of the catheter system 100. For example, in some embodiments, the additional controllers and / or portions of the system controller 126 may be located within and / or incorporated within the handle assembly 128.
[0076] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system console 126. This design allows the GUI 127 to be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to and induce fractures in the vascular lesion 106A at the treatment site 106. The GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. Additionally or alternatively, the GUI 127 can provide the user or operator with dynamic visual data and / or information, 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, varying brightness, etc., which can act as alerts to the user or operator. Additionally or alternatively, the GUI 127 may 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 requirements of the user or operator.
[0077] 1, the handle assembly 128 can be located at or near the proximal portion 114 of the catheter system 100. In this embodiment, the handle assembly 128 is coupled to the balloon 104 and is located separately from the balloon 104. Alternatively, the handle assembly 128 can be located in another suitable location.
[0078] The handle assembly 128 is attached to the catheter shaft 110 and is handled and used by a user or operator to manipulate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. In the embodiment shown in FIG. 1 , the handle assembly 128 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.
[0079] In some embodiments, the handle assembly 128 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in one such embodiment, the handle assembly 128 can include circuitry 156, which can be electrically coupled between the catheter electronics and the system console 123 and form at least a portion of the system controller 126. In one embodiment, the circuitry 156 can include a printed circuit board having one or more integrated circuits or any other suitable circuitry. In alternative embodiments, the circuitry 156 can be omitted or can be included within the system controller 126, which can be located outside the handle assembly 128, such as within the system console 123, in various embodiments. It is understood that the handle assembly 128 can include fewer or additional components than those specifically shown and described herein.
[0080] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with catheter fluid 132 as needed.
[0081] As with all embodiments shown and described herein, various features may be omitted from the drawings for purposes of clarity and ease of understanding. Additionally, the drawings may include features that can be omitted without departing from the spirit and scope of the invention.
[0082] FIG. 2 is a simplified perspective view of an embodiment of an optical-electrical connector assembly 251 having features of the present invention that may be included as part of the catheter system 100 of FIG.
[0083] The design of the optical-electrical connector 251 can vary. As shown, FIG. 2 illustrates various external components and features that may be included in various embodiments of the optical-electrical connector 251. In particular, as shown, the optical-electrical connector 251 can include one or more of a guide coupling (or connector) housing 250, a guide bundler 252, a sealing member 260, a contaminant inhibitor 262, and a locking mechanism 264. Alternatively, the optical-electrical connector 251 can include more or fewer external components than those specifically mentioned.
[0084] One primary purpose of the optical-electrical connector 251 is to provide a means for connecting the ferrule 366 (shown, for example, in FIG. 3) disposed therein, and thus the energy guides 122A disposed at least partially within the ferrule 366, into the console connection opening 148 (or "console receptacle" shown in FIG. 1). Thus, by virtue of the optical-electrical connector 251 and the ferrule 366 and energy guides 122A at least partially held therein and precisely connected and aligned within the console connection opening 148 of the system console 123 (shown in FIG. 1), energy from the energy source 124 (shown in FIG. 1) can be effectively and selectively coupled to each of the one or more energy guides 122A.
[0085] Another primary purpose of the optical-electrical connector 251 is to ensure that a proper electrical connection is established between the system console 123 and the remainder of the catheter system 100. In particular, in various embodiments, the system console 123 can include a first electrical connector 163 (shown in FIG. 1 ), and the optical-electrical connector 251 can include a second electrical connector 465 (shown, for example, in FIG. 4 ) configured to mate with each other to ensure effective transmission of power and data between the system console 123 and the catheter 102 (shown in FIG. 1 ). It should be appreciated that the first electrical connector 163 and the second electrical connector 465 can have any suitable design to effectively ensure effective transmission of power and data between the system console 123 and the catheter 102.
[0086] In various embodiments, the optical-electrical connector 251 and / or the system console 123 (shown in FIG. 1) can include certain features or components to better ensure a more precisely aligned connection therebetween. For example, in some embodiments, the optical-electrical connector 251 may include: (i) a ferrule 366 that can float relative to and / or within a ferrule housing 370 (shown in FIG. 3 ) by virtue of the ferrule housing 370 having a positioning opening 576 (shown in FIG. 5 ) that is slightly larger than the diameter of the ferrule 366 and in which at least a portion of the ferrule 366 is retained; (ii) a ferrule housing 370 that can float relative to the guide coupling housing 250 by selectively moving the ferrule housing 370 (up and down and / or left and right) relative to the guide coupling housing 250 as needed; (iii) a position compensator 374 (shown in FIG. 3 ) configured to provide a spring force to hold the ferrule 366 in an aligned position while still allowing play within the ferrule housing 370; and (iv) a resilient plate 372 (shown in FIG. 3 ) configured to control the floating of the ferrule housing 370 within the guide coupling housing 250. In one embodiment, the system console 123 may include one or more optical sensors 167 (shown in FIG. 1 ) configured to sense the position of the optical-electrical connector 251 and / or the guide coupling housing 250 relative to the system console 123 and / or the console connection opening 148. Based on the sensed position of the optical-electrical connector 251 and / or the guide coupling housing 250 relative to the system console 123 and / or the console connection opening 148, an actuator 169 (shown in FIG. 1 ) may then be actuated, which mechanically pulls the optical-electrical connector 251 precisely into position within the console connection opening 148.
[0087] The guide coupling housing 250 houses a portion of each energy guide 122A, such as the guide proximal end 122P, and is configured to mate with and be selectively retained within the console connection opening 148 to provide a mechanical connection between the energy guide bundle 122 (shown in FIG. 1 ) and the system console 123. The design of the guide coupling housing 250 can be varied to suit the requirements of the catheter system 100 and / or the optical-electrical connector 251. In certain embodiments, the guide coupling housing 250 can be formed from multiple housing members, such as a first housing member 250A and a second housing member 250B, that can be selectively mated to operatively retain various internal components of the optical-electrical connector 251 within a housing cavity 368 (shown in FIG. 3 ) defined therein. In one embodiment, first housing member 250A and second housing member 250B can each form one half of guide coupling housing 250 (such as an upper half and a corresponding lower half in one non-exclusive embodiment), with each half being substantially identical to the other half. It should be appreciated that housing members 250A, 250B can be selectively coupled in any suitable manner. Alternatively, guide coupling housing 250 can have another suitable design. For example, in certain alternative embodiments, guide coupling housing 250 can have three or more housing members or only one housing member.
[0088] It should be appreciated that the guide coupling housing 250 and / or the individual housing members 250A, 250B may be formed from any suitable material that provides an effective housing for protecting the various internal components held therein. The various internal components of the optical-electrical connector 251 are shown and described herein below in connection with FIG.
[0089] The guide bundler 252 is configured to provide strain relief when approximating each of the individual energy guides 122A such that the energy guides 122A and / or the energy guide bundle 122 may become more compact when extended with the catheter 102 (shown in FIG. 1) into the blood vessel 108 (shown in FIG. 1) during use of the catheter system 100. Certain internal components that may be included within the guide bundler 252 to provide strain relief when approximating the energy guides 122A within the energy guide bundle 122 are also shown and described herein below in connection with FIG.
[0090] During use of the catheter system 100, it is desirable to limit the amount of dust and other particles that may otherwise contaminate the guide surface at the proximal guide end 122P (shown in FIG. 1) of each of the one or more energy guides 122A.
[0091] The sealing member 260 is configured to seal the connection between the optical-electrical connector 251 and the system console 123 when the guide coupling housing 250 is inserted into and selectively retained within the console connection opening 148. With such a design, the sealing member 260, which in one non-exclusive example may be provided in the form of a face gasket, can help limit the amount of dust and other particles that might otherwise be introduced into the guide coupling housing 250 and / or the guide coupler 252. In some embodiments, the sealing member 260 can be formed from a resilient material that can effectively provide a sealed connection between the guide coupling housing 250 and the console connection opening 148. Alternatively, the sealing member 260 can be formed from another suitable material.
[0092] Contaminant inhibitor 262 is similarly configured to limit the amount of dust or other particles that could otherwise contaminate the guide surfaces of each of one or more energy guides 122A. More specifically, as shown, contaminant inhibitor 262 can be configured to be disposed around and / or near a portion of guide coupling housing 250 within which ferrule 366, and thus proximal guide end 122P of each energy guide 122A, is retained. Contaminant inhibitor 262 can have any suitable design configured to prevent the introduction of dust and other particles into guide coupling housing 250 while still allowing energy from energy source 124 to be coupled into proximal guide end 122P of each of one or more energy guides 122A.
[0093] In some embodiments, contaminant inhibitor 262 can be disposable such that when contaminant inhibitor 262 becomes sufficiently contaminated with dust and other particles, contaminant inhibitor 262 can simply be discarded. In other embodiments, contaminant inhibitor 262 can be reusable such that it can be selectively removed from guide coupling housing 250, cleaned, and then selectively recoupled to guide coupling housing 250 for additional uses.
[0094] The locking mechanism 264 is configured to selectively lock the optical-electrical connector 251 in place when coupled to the console connection opening 148. More specifically, during use of the catheter system 100, when the optical-electrical connector 251 is inserted into the console connection opening 148 of the system console 123, the optical sensor 167 registers this and activates the actuator 169, which mechanically draws the optical-electrical connector 251 into a predetermined position and locks it in place. The locking mechanism 264 provides an effective means for thus locking the optical-electrical connector 251 in such a position when inserted into the console connection opening 148 such that the optical-electrical connector 251 can be selectively and securely retained in the console connection opening 148.
[0095] FIG. 3 is a simplified plan view of a portion of the optical-electrical connector 251 shown in FIG. 2. More specifically, FIG. 3 illustrates various internal components and features that may be included in various embodiments of the optical-electrical connector 251. As shown in FIG. 3, in various embodiments, the optical-electrical connector 251 may include one or more of the following internally within the guide coupling housing 250: a plurality of ferrules 366, a ferrule housing 370, a portion of one or more energy guides 322A, a resilient plate 372, at least one position compensator 374 (such as a silicone gasket in one non-exclusive example), and at least a portion of the guide bundler 252. It should be appreciated that only the second housing member 250B of the guide coupling housing 250 is visible in FIG. 3 so that the other mentioned components disposed within the housing cavity 368 defined within the guide coupling housing 250 and / or the guide bundler 252 can be clearly seen.
[0096] As used herein, a "ferrule" is a fiber optics component used to protect and align the stripped end of energy guide 322A (or optical fiber). During use, energy guide 322A is inserted into the thin structure of ferrule 366, which may be provided with an adhesive (not shown) to prevent contamination and provide long-term mechanical strength. Ferrule 366 may be formed from any suitable material to provide the desired contamination protection and enhanced long-term mechanical strength for stripped proximal guide end 322P of energy guide 322A.
[0097] The optical-electrical connector 251 may include any suitable number of ferrules 366 within the housing cavity 368 as defined by the guide coupling housing 250, depending on the number of energy guides 322A optically coupled to the energy source 124 (shown in FIG. 1). For example, in one non-exclusive embodiment, as shown in FIG. 3, the optical-electrical connector 251 may include ten ferrules 366, each configured to retain and protect a portion, such as the guide proximal end 322P, of one of the one or more energy guides 322A. Thus, in such an embodiment, the energy guide bundle 322 may include up to ten energy guides 322A. Alternatively, the optical-electrical connector 251 may include more or fewer than ten ferrules 366.
[0098] 3, in some embodiments, the ferrule 366 is positioned within the guide coupling housing 250 such that the ferrule 366 is recessed against the console-facing side 382 of the guide coupling housing 250. Because the ferrule 366 is recessed from the console-facing side 382 of the guide coupling housing 250, the optical-electrical connector 251 is configured to help ensure that fingers or other objects do not come into contact with the surface of the energy guide 322A at the guide proximal end 322P of the energy guide 322A, which could otherwise lead to undesired contamination.
[0099] The ferrule 366 can be recessed to any desired distance from the console-facing side 382 of the guide coupling housing 250 depending on the particular design requirements of the optical-electrical connector 251 and / or catheter system 100 .
[0100] The ferrule housing 370 is configured to provide a housing for the ferrules 366 so that the ferrules 366 can be collectively moved and positioned relative to energy from the energy source 124. The ferrule housing 370 also allows the ferrules 366 to be maintained spaced a desired distance from one another, thereby properly aligning the guide proximal end 322P of each energy guide 322A to correctly receive energy from the energy source 124. On the side of the guide coupling housing 250 facing the console connection opening 148 (shown in FIG. 1) of the system console 123 (shown in FIG. 1), i.e., the left side in FIG. 3, a face of the ferrules 366 is exposed. In certain embodiments, the ferrule 366 can float significantly within and / or relative to the ferrule housing 370, and the ferrule housing 370 can float within and / or relative to the guide coupling housing 250, allowing the ferrule 366, and thus the guide proximal end 322P of the energy guide 322A, to be easily and accurately adjusted for more precise alignment with the console connection opening 148 of the system console 123.
[0101] The resilient plate 372, such as a spring plate in one embodiment, is configured to control the floating of the ferrule housing 370 within and / or relative to the guide coupling housing 250. More specifically, because the ferrule housing 370 can float within the guide coupling housing 250, it is desirable that the ferrule housing 370 not float loosely within the guide coupling housing 250 without control. The resilient plate 372 provides a biasing force that allows the ferrule housing 370 to float within the guide coupling housing 250 while allowing the ferrule housing 370 to be resiliently maintained in place within the guide coupling housing 250 once the desired placement is accurately determined.
[0102] At least one position compensator 374, such as a silicone gasket in one non-exclusive embodiment, is configured to provide a spring force to hold the ferrule 366 in an aligned position while still allowing for play within the ferrule housing 370. However, if the ferrule housing 370 needs to be adjusted to accommodate mating with the ferrule 366 relative to the console connection opening 148 and / or energy from the energy source 124, the ferrule housing 370 can be moved to accommodate such adjusted position. Without the at least one position compensator 374, the ferrule 366 could become stuck in the console connection opening 148 due to mating interference.
[0103] The optical-electrical connector 251 may include any suitable number of position compensators 374. For example, in one non-exclusive embodiment, the optical-electrical connector 251 may include four position compensators 374. Alternatively, in other embodiments, the optical-electrical connector 251 may include more or less than four position compensators 374.
[0104] As described above, the guide bundler 252 is configured to provide strain relief when approximating each of the individual energy guides 322A, allowing the energy guides 322A and / or the energy guide bundle 322 to assume a more compact configuration as they extend with the catheter 102 (shown in FIG. 1) into the blood vessel 108 (shown in FIG. 1) during use of the catheter system 100 (shown in FIG. 1). The design of the guide bundler 252 can vary. For example, as shown in FIG. 3, in one embodiment, the guide bundler 252 can include a shaft jacket 378 within which a portion of all of the energy guides 322A are maintained as the energy guide bundle 322 extends with the catheter 102 toward the balloon 104 (shown in FIG. 1). The guide bundler 252 can further include a locking crimp 380 configured to tightly bundle the energy guides in a controlled manner to form the energy guide bundle 322.
[0105] As shown, FIG. 3 also illustrates the routing of the energy guides 322A as they extend through the guide coupling housing 250 of the optical-electrical connector 251. More specifically, the guide proximal end 322P of each energy guide 322A is positioned within one of the ferrules 366 near the side of the guide coupling housing 250 facing the console connection opening 148 (shown in FIG. 1) of the system console 123, with the energy guides 322A spaced a desired distance apart from one another. The energy guides 322A then extend through the guide coupling housing 250 until they are brought closer together or bundled in the guide bundler 252. The energy guide bundle 322, with portions of the energy guides 322A disposed within the shaft jacket 378, then extends along with the catheter 102 toward the balloon 104.
[0106] In one embodiment, as shown in FIG. 3 , the energy guide 322A can include a service loop 322L. Movement of the energy guide 322A through the catheter system 100 can create alternating periods of slack and tension in the energy guide 322A, which can cause axial and longitudinal movement of the guide and cable. Such movement can cause undesirable binding and / or kinking of the energy guide 322A of the catheter system 300, which can result in degradation of the energy guide 322A. Therefore, the inclusion of the service loop 322L can help prevent any undesirable binding and / or kinking of the energy guide 322A, as the service loop 322L helps minimize the alternating periods of slack and tension in the energy guide 322A.
[0107] In some embodiments, as shown, service loop 322L can be wrapped around service loop guide 384. For example, in one non-exclusive embodiment, energy guide 322A can be wrapped around service loop guide 384 more than about 5 degrees and less than about 1080 degrees. More specifically, energy guide 322A is angled about service loop guide 384 at approximately 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130 degrees, 135 degrees, 140 degrees, 145 degrees, 150 degrees, 155 degrees, 160 degrees, 165 degrees, 170 degrees, 175 degrees, 180 degrees, 185 degrees, 190 degrees, 200 degrees, 210 degrees, 220 degrees, 230 degrees, 240 degrees, 250 degrees, 260 degrees, 270 degrees, 280 degrees, 290 degrees, 300 degrees, 310 degrees, 320 degrees, 330 degrees, 340 degrees, 350 degrees, 360 degrees, 370 degrees, 380 degrees, 390 degrees, 400 degrees, 410 degrees, 420 degrees, 430 degrees, 440 degrees, 450 degrees, 460 degrees, 470 degrees, 480 degrees, 490 degrees, 500 degrees, 510 degrees, 520 degrees, 530 degrees, 540 degrees, 550 degrees, 560 degrees, 570 degrees, 580 degrees, 590 degrees, 600 degrees, 610 degrees, 620 degrees, 630 degrees, 640 degrees, 650 degrees, 660 degrees, 195 degrees, 200 degrees, 205 degrees, 210 degrees, 215 degrees, 220 degrees, 225 degrees, 230 degrees, 235 degrees, 240 degrees, 245 degrees, 250 degrees, 255 degrees, 260 degrees, 265 degrees, 270 degrees, 275 degrees, 280 degrees, 285 degrees, 290 degrees, 295 degrees, 300 degrees, 305 degrees, 310 degrees, 315 degrees, 320 degrees, 325 degrees, 330 degrees, 335 degrees, 340 degrees, 345 degrees, 350 degrees, 355 degrees, 360 degrees, 365 degrees, 370 degrees, 375 degrees, 380 degrees, 385 degrees, 390 degrees, 395 degrees, 400 degrees , 405 degrees, 410 degrees, 415 degrees, 420 degrees, 425 degrees, 430 degrees, 435 degrees, 440 degrees, 445 degrees, 450 degrees, 455 degrees, 460 degrees, 465 degrees, 470 degrees, 475 degrees, 480 degrees, 485 degrees, 490 degrees, 495 degrees, 500 degrees, 505 degrees , 510 degrees, 515 degrees, 520 degrees, 525 degrees, 530 degrees, 535 degrees, 540 degrees, 545 degrees, 550 degrees, 555 degrees, 560 degrees, 565 degrees, 570 degrees, 575 degrees, 580 degrees, 585 degrees, 590 degrees, 595 degrees, 600 degrees, 605 degrees, 610 degrees , 615 degrees, 620 degrees, 625 degrees, 630 degrees, 635 degrees, 640 degrees, 645 degrees, 650 degrees, 655 degrees, 660 degrees, 665 degrees, 670 degrees, 675 degrees, 680 degrees, 685 degrees, 690 degrees, 695 degrees, 700 degrees, 705 degrees, 710 degrees, 715 degrees , 720 degrees, 725 degrees, 730 degrees, 735 degrees, 740 degrees, 745 degrees, 750 degrees, 755 degrees, 760 degrees, 765 degrees, 770 degrees, 775 degrees, 780 degrees, 785 degrees, 790 degrees, 795 degrees, 800 degrees, 805 degrees, 810 degrees, 815 degrees, 820 degrees,825 degrees, 830 degrees, 835 degrees, 840 degrees, 845 degrees, 850 degrees, 855 degrees, 860 degrees, 865 degrees, 870 degrees, 875 degrees, 880 degrees, 885 degrees, 890 degrees, 895 degrees, 900 degrees, 905 degrees, 910 degrees, 915 degrees, 920 degrees, 925 degrees, 930 degrees, 935 degrees, 940 degrees, 945 degrees, 950 degrees, 955 degrees, 960 degrees, 965 degrees, 97 The energy guide 322A can be wrapped by 0 degrees, 975 degrees, 980 degrees, 985 degrees, 990 degrees, 995 degrees, 1000 degrees, 1005 degrees, 1010 degrees, 1015 degrees, 1020 degrees, 1025 degrees, 1030 degrees, 1035 degrees, 1040 degrees, 1045 degrees, 1050 degrees, 1055 degrees, 1060 degrees, 1065 degrees, 1070 degrees, 1075 degrees, or 1080 degrees. In other embodiments, the energy guide 322A can be wrapped less than about 5 degrees or more than about 1080 degrees around the service loop guide 384.
[0108] The service loop guide 384 guides at least one of the movement and positioning of the energy guide 322A within the optical-electrical connector 251. The service loop guide 384 can reduce mechanical strain on the service loop 322L, various cables, guides, and / or other components within the optical-electrical connector 251. As shown in FIG. 3, the service loop 322L includes a portion of the energy guide 322A to reduce mechanical strain and / or mechanical forces that may act on the energy guide 322A.
[0109] The service loop guide 384 can cooperate with the guide bundler 252 to allow a user to service the energy guide 322A. For example, the guide bundler 252 can be at least partially removable to expose the energy guide 322A and / or the service loop 322L, thereby allowing an operator to service, repair, and / or remove the energy guide 322A (or any other component of the optical-electrical connector 251).
[0110] The service loop guide 384 and the guide bundler 252 may cooperate to (i) provide a storage area for the energy guide 322A and / or (ii) maintain the functionality of the energy guide 322A. The details of the service loop guide 384 may vary depending on the design requirements of the catheter system 100, the optical-electrical connector 251, and / or the particular needs, specifications, and / or requirements of the user or operator.
[0111] The service loop guide 384 can position components such as the energy guide 322A and / or the service loop 322L. For example, as shown in FIG. 3 , the service loop guide 384 can position the service loop 322L portion of the energy guide 322A in a somewhat circular pattern. It should be appreciated that the service loop guide 384 can take the form of any suitable geometric structure, and the service loop guide 384 is depicted as a circle in FIG. 3 solely for ease of understanding. The service loop guide 384 can define a path that can accommodate a portion of the energy guide 322A, thereby allowing the portion to form a loop (e.g., service loop 322L) around the service loop guide 384. The service loop guide 384 can be configured to allow movement of the guide distal end 122D (shown in FIG. 1 ) of each energy guide 322A relative to the optical-electrical connector 251.
[0112] In certain embodiments, the service loop guide 384 increases the likelihood that a portion of the energy guide 322A (e.g., the service loop 322L) will remain in a looped orientation such that tension or axial movement experienced by the energy guide 322A will not cause the energy guide 322A to twist or bend at an undesired angle, thereby reducing the likelihood of damage to the energy guide 322A.
[0113] The service loop guide 384 may include a post or other structure having a width that maintains the spacing or diameter of the portion of the energy guide 322A disposed within the service loop 322L. The width of the service loop guide 384 may be greater than the maximum bend or twist radius of the energy guide 322A, which may depend on the particular material from which the energy guide 322A is constructed.
[0114] In some embodiments, the service loop guide 384 may include a guide receiver (not shown) for receiving a portion of the energy guide 322A, thereby positioning the energy guide 322A toward the handle assembly 128. The guide receiver may be offset from the portion of the service loop guide 384 around which the energy guide 322A is wrapped, thereby providing spacing between the energy guides 322A within the guide bundler 252.
[0115] The service loop guide 384 may include, for example, a channel, groove, recess, opening, or similar passageway in the body of the service loop guide 384. Although not shown, the service loop guide 384 may include multiple paths for additional energy guides 322A and / or electrical cables 386 coupled to the optical-electrical connector 251 to aid in managing and positioning the energy guides 322A and / or electrical cables 386 through the length of the catheter system 100 to reduce the possibility of tangling, kinking, etc. The electrical cables 386 may connect various portions of the handle assembly 128 and / or optical-electrical connector 251 to any suitable power source (such as the power source 125 shown in FIG. 1 ).
[0116] In other embodiments, the service loop guide 384 can be omitted for the catheter system 100, and the energy guide 322A can form one or more loops (such as service loop 322L) to provide additional length at the guide distal end 122D only if needed.
[0117] 3, the optical-electrical connector 251 also includes a second electrical connector 465 (shown in phantom and more clearly shown in FIG. 4) configured to mate with the first electrical connector 163 (shown in FIG. 1) on the system console 123 to effectively transfer power and data between the system console 123 and the catheter 102. As noted above, the electrical connection assembly including the first electrical connector 163 and / or the second electrical connector 465 can also include an electrical cable 386 electrically coupled to the second electrical connector 465 to more effectively transfer power and data, as needed, between the system console 123 and various other components of the catheter system 100, such as the catheter 102.
[0118] Figure 4 is a simplified bottom view of the optical-electrical connector 251 shown in Figure 2. More specifically, Figure 4 is a simplified bottom view of the optical-electrical connector 251 showing the guide coupling housing 250, the guide bundler 252, and the second electrical connector 465 disposed within and / or adjacent to the guide coupling housing 250.
[0119] As shown, the second electrical connector 465 is configured to couple with the first electrical connector 163 (shown in FIG. 1) disposed within the system console 123 (shown in FIG. 1) to ensure effective transmission of power and / or data between the system console 123 and the catheter 102 (shown in FIG. 1) when the optical-electrical connector 251 is mechanically coupled to the system console 123.
[0120] The second electrical connector 465 may have any suitable design for mating with the first electrical connector 163. For example, in one non-exclusive embodiment, as shown in FIG. 4 , the second electrical connector 465 may include a connector base 465A in the form of a printed circuit board or the like and a plurality of electrical connection (conductive) pads 465B coupled to and / or attached to the connector base 465A. Each of the plurality of electrical connection pads 465B is configured to interlock with a corresponding electrical connection component included as part of the first electrical connector 163. In some embodiments, the electrical connection pads 465B may be recessed within the connector base 465A to prevent inadvertent contact with the electrical connection pads 465B, such as by fingers, during use and operation of the optical-electrical connector 251. Furthermore, the size and / or spacing of the electrical connection pads 465B may be configured such that a typical-sized finger is too large to directly access and contact the electrical connection pads 465B within the recesses. Rather, fingers generally instead contact connector base 465A on either side of the recess. Alternatively, second electrical connector 465 may have another suitable design that may also be configured to prevent inadvertent contact with electrical connection pads 465B. Further alternatively, second electrical connector 465 may be arranged in another suitable format other than that specifically shown in FIG.
[0121] The second electrical connector 465 may include any suitable number of electrical connection pads 465B to ensure the desired electrical connection between the system console 123 and the catheter 102. For example, in one embodiment, as shown in FIGURE 4, the second electrical connector 465 may include five electrical connection pads 465B coupled to, attached to, and / or recessed into a connector base 465A. Alternatively, the second electrical connector 465 may include more or less than five electrical connection pads 465B coupled to, attached to, and / or recessed into a connector base 465A.
[0122] FIG. 5 is a simplified end view of the optical-electrical connector 251 shown in FIG. 2. More specifically, FIG. 5 illustrates a face 566F of each ferrule 366 when the ferrules 366 are held in a desired, generally spaced apart position within the ferrule housing 370. In some embodiments, as shown, the ferrules 366 are positioned within locating openings 576 formed within the ferrule housing 370. As shown, the locating openings 576 can be sized to have a tolerance that allows for a loose fit of the ferrules 366 within the locating openings 576. In other words, in some embodiments, the locating openings 576 are slightly larger than the diameter of the ferrules 366 to allow movement of the ferrules 366 relative to the ferrule housing 370. This design allows the ferrule 366 to float significantly in the ferrule housing 370, as described above, to allow the ferrule 366, and thus the guide proximal end 322P (shown in FIG. 3) of the energy guide 322A (shown in FIG. 3), to be more precisely aligned with the energy from the energy source 124 (shown in FIG. 1) when the optical-electrical connector 251 is positioned within the console connection opening 148 (shown in FIG. 1) of the system console 123 (shown in FIG. 1).
[0123] When the optical-electrical connector 251 is advanced into the console connection opening 148, the ferrule 366 finds a home in the console connection opening 148 due to the chamfered lead-in at the console connection opening 148. This allows for close tolerances in the console connection opening 148 for driving mating and close tolerances on the outer diameter of the ferrule 366.
[0124] In various embodiments, the ferrule housing 370 may be selectively adjustable to a predetermined position within the guide coupling housing 250 to better enable desired alignment between the energy guides 322A and the energy from the energy source 124. In other words, in addition to a loose fit between the ferrules 366 and the locating openings 576 in the ferrule housing 370, the ferrule housing 370 may also be allowed to float (up and down and / or side to side) within the assembled guide coupling housing 250. Such a design further enhances enabling accurate and precise positioning of the guide proximal end 322P of each energy guide 322A relative to the energy from the energy source 124.
[0125] FIG. 6 is a simplified plan view of a portion of another embodiment of an optical-electrical connector assembly 651. As shown, the optical-electrical connector 651 is substantially similar to the embodiment of the optical-electrical connector 251 shown and described herein above. For example, as shown in FIG. 6, the optical-electrical connector 651 also includes a guide coupling housing 650, a guide bundler 652, a ferrule 666, a ferrule housing 670, a resilient plate 672, and a position compensator 674, which are substantially similar in design and function to the corresponding components shown and described herein above. Accordingly, such components will not be described in further detail. It should be appreciated that the optical-electrical connector 651 can, and likely does, include a sealing member 260 (shown in FIG. 2), a contaminant inhibitor 262 (shown in FIG. 2), and a locking mechanism 264 (shown), although such components are not shown in FIG. 6.
[0126] However, in this embodiment, the energy guide bundle 622 and / or energy guide 622A does not include the service loop 322L when the energy guide 622A is threaded through the guide coupling housing 650 and / or guide bundler 652 of the optical-electrical connector 651. Thus, without the service loop 322L formed in the optical-electrical connector 651, the path of the energy guide 622A through the optical-electrical connector 651 is somewhat different than that of the previous embodiment. In particular, as shown, the path of the energy guides 622A as they extend through the guide coupling housing 650 of the optical-electrical connector 651 and the guide bundler 652 includes the guide proximal end 622P of each energy guide 622A positioned within one of the ferrules 666 near the side of the guide coupling housing 650 facing the console connection opening 148 (shown in FIG. 1) of the system console 123, with the energy guides 622A spaced a desired distance from one another. The energy guides 622A then extend through the guide coupling housing 650 until they are brought closer together or bundled in the guide bundler 652. The energy guide bundle 622, with the energy guides 622A positioned within the shaft jacket 678, then extends with the catheter 102 (shown in FIG. 1) toward the balloon 104 (shown in FIG. 1).
[0127] Figure 7A is a simplified top perspective view of a portion of yet another embodiment of an optical-electrical connector assembly 751. In particular, Figure 7A is a simplified top perspective view of a portion of a guide coupling housing 750, namely, a second housing member 750B, a guide bundler 752, and an embodiment of a second electrical connector 765 disposed within and / or adjacent to the guide coupling housing 750. In this embodiment, the design of the second electrical connector 765 differs somewhat from that shown and described herein above.
[0128] As shown, the second electrical connector 765 is also configured to couple with the first electrical connector 163 (shown in FIG. 1) disposed within the system console 123 (shown in FIG. 1) to ensure effective transmission of power and data between the system console 123 and the catheter 102 (shown in FIG. 1) when the optical-electrical connector 751 is mechanically coupled to the system console 123.
[0129] 7A , the second electrical connector 765 also includes a connector base 765A, such as in the form of a printed circuit board, and a plurality of electrical connection pads 765B coupled and / or attached to the connector base 765A and configured to couple with corresponding electrical connection components included as part of the first electrical connector 163. It will also be appreciated that the second electrical connector 765 can include any suitable number of electrical connection pads 765B, and that the number of electrical connection pads 765B will also generally correspond to the number of corresponding electrical connection components included as part of the first electrical connector 163.
[0130] Figure 7B is a simplified bottom view of a portion of the optical-electrical connector assembly 751 shown in Figure 7A. More specifically, Figure 7B is a simplified bottom perspective view of a portion of the guide coupling housing 750, namely, the second housing member 750B, the guide bundler 752, and the second electrical connector 765 disposed within and / or adjacent to the guide coupling housing 750, as shown in Figure 7A.
[0131] As shown in FIG. 7B , the second electrical connector 765 is disposed within a recessed region 790 formed in the second housing member 750B. As further shown, a plurality of spacers 792 are included within the recessed region 790 and extend generally away from the surface of the second housing member 750B. The spacers 792 are disposed between the electrical connection pads 765B of the second electrical connector 765. The size and shape of the spacers 792, as well as the spacing between the electrical connection pads 765B of the second electrical connector 765, are specifically designed to prevent inadvertent contact with the electrical connection pads 765B, such as by the fingers of a user or operator of the catheter system 100 (shown in FIG. 1 ), during use and operation of the optical-electrical connector 751. Thus, with such a design, the electrical connection pads 765B of the second electrical connector 765 are effectively recessed relative to the entire surface of the second housing member 750B in a manner that protects the integrity of the electrical connection pads 765B while still allowing for the desired coupling between the electrical connection pads 765B of the second electrical connector 765 and the corresponding electrical connection components included as part of the first electrical connector 163.
[0132] The present technology also relates to methods for treating treatment sites within or adjacent to a vessel wall, such methods utilizing the devices disclosed herein.
[0133] In summary, in accordance with various embodiments of the present invention as shown and described in detail herein, a catheter system and associated methods can include a catheter configured to be advanced to a vascular lesion, such as a calcified vascular lesion or a fibrovascular lesion, at a treatment site located 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 catheter fluid therein for expansion from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for securing the catheter in place relative to the treatment site.
[0134] In certain embodiments, the catheter system and related methods utilize an energy source, e.g., a light source such as a laser source or another suitable energy source, that provides energy guided by one or more energy guides, e.g., optical guides such as optical fibers, disposed along the catheter shaft and within the balloon of the balloon to generate localized plasma in the catheter fluid held within the balloon of the balloon. The energy guides can be used in conjunction with a plasma generator disposed at or near the distal end of the energy guide within the balloon of the balloon positioned at the treatment site. The generation of localized plasma can initiate a pressure wave and the rapid formation of one or more bubbles, which can rapidly expand to a maximum size and then dissipate through a cavitation event that can release a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles (sometimes simply referred to as "plasma bubbles") can generate one or more pressure waves in the catheter fluid held within the balloon of the balloon, thereby applying pressure waves to vascular lesions at the treatment site within or adjacent to the vessel wall within the patient's body, inducing disruption therein. In some embodiments, an energy source can be configured to provide sub-millisecond pulses of energy, e.g., light energy, to initiate plasma formation in the catheter fluid within the balloon, causing rapid bubble formation and applying pressure waves to the balloon wall at the treatment site. The pressure waves can thus deliver mechanical energy through the incompressible catheter fluid to the treatment site and apply a spalling force to the intravascular lesion. Without wishing to be bound by any particular theory, it is believed that the rapid change in catheter fluid momentum relative to the balloon wall in contact with the intravascular lesion is transferred to the intravascular lesion, inducing spallation of the lesion.
[0135] Importantly, the catheter systems and related methods disclosed herein further include an optical-electrical connector configured to ensure proper alignment and coupling of the ferrules each holding a portion of one of the one or more energy guides to a system console, which may include various operating components of the catheter system, such as an energy source, a power source, and at least a portion of a system controller. More specifically, use of an optical-electrical connector having features of the present invention allows the one or more energy guides to be properly aligned within the console connection opening of the system console, thereby more precisely and accurately directing energy from the energy source to the proximal ends of each of the one or more energy guides before such energy is guided by the one or more energy guides into the balloon. In various embodiments, the optical-electrical connector can be further configured to ensure that the guide surfaces at the proximal ends of the energy guides, toward which energy from the energy source is directed, are substantially free of dust and particles that may otherwise contaminate the guide surfaces.
[0136] In many embodiments, the optical-electrical connector is further configured to ensure that a proper electrical connection is established between the system console and the catheter to enable effective transmission of power and data between the system console and the catheter. More specifically, an electrical connector integrated as part of the optical-electrical connector is configured to mate with a corresponding electrical connector within the system console to ensure effective transmission of power and data between the system console and the catheter.
[0137] 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.
[0138] It should also be noted that, as used in this specification and the appended claims, the term "configured to" refers to a system, apparatus, or other structure that is constructed or arranged to perform a particular task or adopt a particular configuration. The term "configured to" can be used interchangeably with other similar terms, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.
[0139] It should be appreciated that the drawings shown and described are not necessarily drawn to scale, but are provided for ease of reference and understanding and for the relative placement of structures.
[0140] The headings used herein are provided for consistency with the suggestions of 37 CFR Rule 1.77 or to otherwise provide organizational cues. These headings are not to be viewed as limiting or characterizing the invention(s) set forth in any claim that may arise from this disclosure. By way of illustration, a description of technology in the "Background" section is not an admission that that 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) set forth in the issued claims.
[0141] 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 others skilled in the art can appreciate and understand the principles and practices. Accordingly, aspects have been described in connection with various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the present disclosure.
[0142] While many different embodiments of catheter systems are 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 that such combinations meet the intent of the invention.
[0143] While many exemplary aspects and embodiments of the catheter system have been described above, those skilled in the art will recognize certain modifications, variations, additions, and subcombinations thereof. Accordingly, the following appended claims and the claims hereafter issued are intended to be interpreted to include all such modifications, variations, additions, and subcombinations as fall within their true spirit and scope, and no limitations are intended to the details of construction or design shown herein.
Claims
1. A catheter system for treating treatment sites within or adjacent to blood vessels in a patient's body, Catheter and, System console including console connection opening, An energy source configured to generate energy, One or more energy guides configured to receive the energy from the energy source, An optical-electric connector coupled to the catheter, the optical-electric connector comprising: (i) a guide coupling housing that holds at least a portion of each of the one or more energy guides, the guide coupling housing being configured to be selectively mechanically connected to the system console, and at least a portion of the guide coupling housing being configured to fit into and selectively hold within the console connection opening such that the one or more energy guides are adjustablely aligned with respect to the energy from the energy source within the guide coupling housing to receive the energy from the energy source; and (ii) at least a portion of an electrical connector assembly positioned adjacent to the guide coupling housing and transmitting at least one of power and data between the system console and the catheter when the guide coupling housing is held within the console connection opening; A catheter system equipped with [a specific feature / feature].
2. The catheter system according to claim 1, wherein the electrical connection assembly includes a first electrical connector located within the system console and a second electrical connector located adjacent to the guide coupling housing, the second electrical connector being configured to connect with the first electrical connector when the guide coupling housing is held within the console connection opening.
3. The catheter system according to claim 2, wherein the second electrical connector includes a connector base and a plurality of electrical connection pads coupled to the connector base.
4. The catheter system according to claim 2, wherein the electrical connection assembly further includes the second electrical connector and an electrical cable electrically connected to the catheter.
5. The catheter system according to claim 1, wherein the energy source is located within the system console.
6. The catheter system according to claim 1, wherein the optical-electric connector further comprises (i) a plurality of ferrules, each of which is configured to hold a portion of one of the one or more energy guides, and (ii) a ferrule housing having a plurality of positioning openings, each of which is configured to hold at least a portion of one of the plurality of spaced-apart ferrules, wherein each of the positioning openings is larger than the diameter of the ferrule held within the positioning opening so that the ferrule can move relative to the positioning opening.
7. The catheter system according to claim 6, wherein the ferrule housing is adjustablely positioned within the guide coupling housing such that the ferrule housing is movable relative to the guide coupling housing.
8. The catheter system according to claim 6, wherein the guide coupling housing includes a console-facing side, and the plurality of ferrules are recessed from the console-facing side of the guide coupling housing.
9. The catheter system according to claim 1, wherein the optical-electric connector further includes a sealing member that seals the connection between the guide coupling housing and the console connection opening.
10. The catheter system according to claim 1, wherein the optical-electric connector further comprises a contaminant inhibitor that can be positioned around at least a portion of the guide coupling housing, the contaminant inhibitor being configured to prevent dust and particles from contaminating each of the one or more energy guide surfaces.
11. The catheter system according to claim 1, wherein the optical-electric connector further includes a locking mechanism configured to selectively lock the guide coupling housing in a predetermined position when the guide coupling housing is held within the console connection opening.
12. The catheter system according to claim 1, wherein the system console further includes an optical sensor and an actuator, the optical sensor being configured to sense the position of the guide coupling housing relative to the console connection opening, and the optical sensor being further configured to activate the actuator which mechanically pulls the guide coupling housing into a predetermined position within the console connection opening.
13. The catheter system according to claim 1, further comprising a balloon configured to be substantially adjacent to the treatment site, wherein the balloon includes a balloon wall that defines the interior of the balloon, the balloon is configured to hold catheter fluid inside the balloon, each of the one or more energy guides includes a distal end of the guide configured to be positioned inside the balloon, each of the one or more energy guides is configured to guide the energy from the energy source through the energy guide into the balloon, and each of the one or more energy guides guiding the energy from the energy source into the balloon generates plasma in the catheter fluid inside the balloon.
14. The catheter system according to claim 1, wherein at least one of the one or more energy guides includes an optical fiber, and the energy source includes a laser.
15. A catheter system for treating treatment sites within or adjacent to blood vessels in a patient's body, Catheter and, A system console including a console connection opening, a light sensor and an actuator, An energy source configured to generate energy, One or more energy guides configured to receive the energy from the energy source, A photoelectric connector coupled to the catheter, wherein the photoelectric connector is (i) A guide coupling housing that holds at least a portion of each of the one or more energy guides, the guide coupling housing being configured to be selectively mechanically connected to the system console, and at least a portion of the guide coupling housing being configured to fit into and selectively hold within the console connection opening such that the one or more energy guides are adjustablely aligned with respect to the energy from the energy source within the guide coupling housing to receive the energy from the energy source, and the optical sensor is further configured to activate an actuator that mechanically pulls the guide coupling housing into a predetermined position within the console connection opening, (ii) At least a portion of an electrical connector assembly positioned adjacent to the guide coupling housing and transmitting at least one of power and data between the system console and the catheter when the guide coupling housing is held within the console connection opening, wherein the electrical connection assembly includes a first electrical connector positioned within the system console and a second electrical connector positioned adjacent to the guide coupling housing, the second electrical connector being configured to connect with the first electrical connector when the guide coupling housing is held within the console connection opening, and the second electrical connector includes at least a portion of an electrical connector assembly including a connector base and a plurality of electrical connection pads coupled to the connector base, (iii) A plurality of ferrules, each of which is configured to hold a portion of one of the one or more energy guides, (iv) A ferrule housing having a plurality of positioning openings, each configured to hold at least a portion of one of the plurality of ferrules spaced apart from each other, wherein each of the plurality of positioning openings is larger than the diameter of the ferrule held within the positioning opening so that the ferrule can move relative to the positioning opening, and the ferrule housing is adjustablely positioned within the guide coupling housing so that the ferrule housing is movable relative to the guide coupling housing, A catheter system comprising an optical-electric connector.