Optoelectronic connector for intravascular lithotripsy device
By designing a catheter system containing photoelectric connectors, the problems of vascular patency and treatment delivery parameters are solved, and efficient treatment of intravascular lesions are achieved.
Patent Information
- Application Number
- CN202380051647.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-08-03
- Filing Date
- 2023-08-04
- Publication Date
- 2025-02-18
AI Technical Summary
The prior art is difficult to effectively improve vascular patency, and there are challenges in controlling and optimizing therapeutic delivery parameters in the intravascular lithotripsy catheter system.
A catheter system is designed, including a catheter, a system console, an energy source, an energy guide and an optoelectronic connector. The photoelectric connector connects the housing and electrical connector assembly through a guide, ensuring that the energy guide communicates with the light of the energy source and transmits power and data between the system console and the conduit.
Efficient treatment of intravascular lesions is achieved. Through the precise alignment and connection of photoelectric connectors, the energy of the energy source is effectively directed to the treatment site, generating plasma and pressure waves, thereby breaking the vascular lesions.
Smart Images

Figure CN119486676A_ABST
Abstract
Description
[0001] Related Applications
[0002] This application is related to and claims priority to U.S. Provisional Patent Application Serial No. 63 / 395,853, filed on August 7, 2022, entitled “OPTOELECTRICAL CONNECTOR FOR INTRAVASCULAR LITHOTRIPSY DEVICE” and U.S. Patent Application Serial No. 18 / 365,101, filed on August 3, 2023, entitled “OPTOELECTRICAL CONNECTOR FOR INTRAVASCULAR LITHOTRIPSY DEVICE”. To the extent permitted, the contents of U.S. Application Serial No. 63 / 395,853 and U.S. Patent Application Serial No. 18 / 365,101 are incorporated herein by reference in their entirety.
[0003] background
[0004] Vascular lesions within the body's vessels may be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, etc. Severe vascular lesions, such as heavily calcified vascular lesions, may be difficult for physicians in a clinical setting to treat and achieve patency.
[0005] Vascular lesions can be treated using interventions such as medical therapy, balloon angioplasty, atherectomy, stenting, vascular bypass grafting, etc. These interventions may not always be ideal or may require subsequent treatment to resolve the lesion.
[0006] Intravascular lithotripsy is a method recently used to destroy vascular lesions within a blood vessel in the body with some success. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics generated within a fluid-filled balloon catheter. In particular, during intravascular lithotripsy treatment, a high energy source is used to generate plasma and ultimately pressure waves and rapid bubble expansion within a fluid-filled balloon to break up calcification at the treatment site including one or more vascular lesions within the vascular system. The associated rapid bubble formation triggered by the plasma and the resulting local fluid velocity within the balloon transfer mechanical energy through the incompressible fluid to exert a breaking force on the intravascular calcium relative to the balloon wall. The rapid change in fluid momentum when impacting the balloon wall is referred to as hydraulic shock or water hammer.
[0007] It is always desirable to enhance vessel patency and optimize therapy delivery parameters in intravascular lithotripsy catheter systems in a manner that is relatively easily controlled and consistently manufacturable.
[0008] Overview
[0009] 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 directors, and an optoelectronic connector. The system console includes a console connection hole. The energy source is configured to generate energy. One or more energy directors are configured to receive energy from the energy source. The optoelectronic connector is connected to the catheter. The optoelectronic connector includes a director connection housing that holds at least a portion of each of the one or more energy directors. The director connection housing is configured to selectively mechanically connect to the system console, wherein at least a portion of the director connection housing is configured to fit and selectively remain in the console connection hole so that one or more energy directors are in the director connection housing and are adjustably aligned relative to energy from the energy source to receive energy from the energy source. The optoelectronic connector also includes at least a portion of an electrical connector assembly that is positioned adjacent to the director connection housing and that transmits at least one of power and data between the system console and the catheter when the director connection housing is held in the console connection hole.
[0010] In many embodiments, 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 is configured to mate with the first electrical connector when the guide coupling housing is retained within the console connection aperture.
[0011] In some embodiments, the second electrical connector includes a connector base and a plurality of electrical connection pads coupled to the connector base.
[0012] In certain embodiments, the electrical connection assembly further includes an electrical cable electrically connected to the second electrical connector and the conduit.
[0013] In some embodiments, the energy source is located within the system console.
[0014] In some embodiments, the optoelectronic connector further comprises (i) a plurality of ferrules, each of the plurality of ferrules being configured to hold a portion of one of the one or more energy directors, and (ii) a ferrule housing having a plurality of locating holes, each of the plurality of locating holes being configured to hold at least a portion of one of the plurality of ferrules spaced apart from one another. In some embodiments, each of the plurality of locating holes is larger than a diameter of a ferrule held therein to allow the ferrule to move relative to the locating hole.
[0015] In some embodiments, the ferrule housing is adjustably positionable within the introducer coupling housing such that the ferrule housing is moveable relative to the introducer coupling housing.
[0016] In certain embodiments, the introducer coupling housing includes a console-facing side; and the plurality of ferrules are recessed from the console-facing side of the introducer coupling housing.
[0017] In some embodiments, the optoelectronic connector further includes a sealing member that seals a connection between the guide coupling housing and the console connection hole.
[0018] In certain embodiments, the optoelectronic connector further includes a contaminant inhibitor positionable about at least a portion of the director coupling housing, the contaminant inhibitor configured to inhibit dust and particles from contaminating a face of each of the one or more energy directors.
[0019] In some embodiments, the optoelectronic 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 aperture.
[0020] In some embodiments, the system console further comprises an optical sensor and an actuator. In some embodiments, the optical sensor is configured to sense the position of the guide coupling housing relative to the console connection hole, and is also configured to activate the actuator, which mechanically pulls the guide coupling housing into a proper position within the console connection hole.
[0021] In many embodiments, the catheter system also includes a balloon configured to be positioned substantially adjacent to the treatment site. The balloon includes a balloon wall defining an interior of the balloon. The balloon is configured to retain the catheter fluid within the interior of the balloon. In some embodiments, each of the one or more energy directors includes a director distal end configured to be positioned within the interior of the balloon. Each of the one or more energy directors is configured to direct energy from an energy source through the energy director and into the interior of the balloon. In certain embodiments, each of the one or more energy directors that direct energy from the energy source to the interior of the balloon generates plasma in the catheter fluid within the interior of the balloon.
[0022] In various embodiments, at least one of the one or more energy directors comprises an optical fiber; and the energy source comprises a laser.
[0023] The present invention also relates to a method for treating a treatment site within or adjacent to a blood vessel in a patient's body, comprising the following steps: providing a system console including a console connection hole; generating energy using an energy source; receiving energy from the energy source using one or more energy directors; connecting an optoelectronic connector to a catheter, the optoelectronic connector including a director connection housing and at least a portion of an electrical connector assembly; maintaining at least a portion of each of one or more energy directors with the director connection housing of the optoelectronic connector; selectively mechanically connecting the director connection housing to the system console, wherein at least a portion of the director connection housing is configured to fit and selectively remain in the console connection hole so that one or more energy directors are adjustably aligned within the director connection housing and relative to energy from the energy source to receive energy from the energy source; and when the director connection housing is maintained in the console connection hole, transmitting at least one of power and data between the system console and the catheter using the electrical connector assembly.
[0024] The present invention also relates to 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 comprising a console connection hole, an optical sensor and an actuator; an energy source configured to generate energy; one or more energy directors configured to receive energy from the energy source; and an optoelectronic connector connected to the catheter, the optoelectronic connector comprising: (i) a director connection housing, the director connection housing retaining at least a portion of each of the one or more energy directors, the director connection housing being configured to selectively mechanically connect to the system console, wherein at least a portion of the director connection housing is configured to fit and selectively retain within the console connection hole so that the one or more energy directors are within the director connection housing and are adjustably aligned relative to energy from the energy source to receive energy from the energy source, the optical sensor being configured to sense a position of the director connection housing relative to the console connection hole, and further configured to activate an actuator that mechanically pulls the director connection housing into an appropriate position within the console connection hole; and (ii) an electrical connector assembly. The invention relates to a system console and a catheter for transmitting at least one of power and data between a system console and a catheter, wherein the electrical connector assembly is positioned adjacent to the guide coupling housing and transmits at least one of power and data between the system console and the catheter when the guide coupling housing is retained in the console connection hole, the electrical connection assembly comprising a first electrical connector positioned in the system console and a second electrical connector positioned adjacent to the guide coupling housing, the second electrical connector being configured to dock with the first electrical connector when the guide coupling housing is retained in the console connection hole, the second electrical connector comprising a connector base and a plurality of electrical connection pads coupled to the connector base; (iii) a plurality of ferrules, each of the plurality of ferrules being configured to retain a portion of one of the one or more energy directors; and (iv) a ferrule housing having a plurality of locating holes, each of the plurality of locating holes being configured to retain at least a portion of one of the plurality of ferrules spaced apart from each other, each of the plurality of locating holes being larger than a diameter of a ferrule retained therein to allow the ferrule to move relative to the locating holes, the ferrule housing being adjustably positioned in the guide coupling housing so that the ferrule housing can move relative to the guide coupling housing.
[0025] This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and upon viewing the accompanying drawings, which form a part thereof, each of which should not be construed as limiting. The scope of this article is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The novel features of the invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying description, when considered in conjunction with the accompanying drawings, in which like reference characters represent like parts, and in which:
[0028] Figure 1 is a simplified schematic cross-sectional view of an embodiment of a catheter system according to various embodiments;
[0029] Figure 2 is a simplified perspective view of an embodiment of an optoelectronic connector assembly having features of the present invention, which may be included as Figure 1 part of the ductal system;
[0030] Figure 3 yes Figure 2 A simplified top view of a portion of an optoelectronic connector assembly is shown;
[0031] Figure 4 yes Figure 2 A simplified bottom view of the optoelectronic connector assembly is shown;
[0032] Figure 5 yes Figure 2 A simplified end view of an optoelectronic connector assembly is shown;
[0033] Figure 6 is a simplified top view of a portion of another embodiment of an optoelectronic connector assembly;
[0034] Fig. 7A is a simplified top perspective view of a portion of yet another embodiment of an optoelectronic connector assembly; and
[0035] Figure 7B yes Fig. 7A A simplified bottom view schematic diagram of a portion of an optoelectronic connector assembly is shown in FIG.
[0036] Although embodiments of the present invention allow for various modifications and alternative forms, their specific details have been illustrated by way of example and drawings and are described in detail herein. However, it is to be understood that the scope of this article is not limited to the specific embodiments described. On the contrary, the purpose is to cover modifications, equivalents, and alternatives that fall within the spirit and scope of this article.
[0037] describe
[0038] Treatment of vasculopathy can reduce major adverse events or death in affected subjects. As described herein, a major adverse event is a major adverse event that may occur anywhere in the body due to the presence of a vasculopathy. Major adverse events can include, but are not limited to, major adverse cardiac events, major adverse events of the peripheral vasculature or central vasculature, major adverse events of the brain, major adverse events of the muscular system, or major adverse events of any internal organ.
[0039] In various embodiments, the catheter systems and related methods disclosed herein may include a catheter configured to be advanced to a vascular lesion at a treatment site, the treatment site being located within or adjacent to a blood vessel in a patient's body, the vascular lesion being, for example, a calcified vascular lesion or a fibrotic vascular lesion. As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably unless otherwise indicated. Thus, intravascular lesions and / or vascular lesions are sometimes referred to herein simply as "lesions."
[0040] Those of ordinary skill in the art will appreciate that the following detailed description of the present invention is illustrative only and is not intended to be limiting in any way. Other embodiments of the present invention will readily occur to such technicians who benefit from this disclosure. Reference will now be made in detail to the embodiments of the present invention shown in the accompanying drawings. In the accompanying drawings and the following detailed description, the same or similar names and / or reference numerals will be used to refer to the same or similar parts.
[0041] For the sake of clarity, not all conventional features of the embodiments described herein are shown and described. It is to be understood that in the development of any such actual embodiment, many decisions unique to the embodiment must be made to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and these specific goals will vary from one embodiment to another and from one developer to another. In addition, it should be recognized that such development efforts may be complex and time-consuming, however, for those of ordinary skill in the art who benefit from this disclosure, this is nothing more than a routine engineering task.
[0042] The catheter systems disclosed herein may include many different forms. Figure 1 , shows a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments. The catheter system 100 is suitable for applying pressure waves to induce a fracture in one or more vascular lesions in a patient's body, the one or more vascular lesions being in or adjacent to a vessel wall of a blood vessel, or on or adjacent to a heart valve. Figure 1In the illustrated embodiment, the catheter system 100 may include one or more of a catheter 102, an energy guide bundle 122 including one or more energy directors 122A, a source manifold 136, a fluid pump 138, a system console 123, and a handle assembly 128, wherein the system console 123 includes one or more of an energy source 124, a power source 125, a system controller 126, and a graphical user interface 127 ("GUI"). In various embodiments, the catheter system 100 also includes an optoelectronic connector assembly 151 (also referred to herein as an "optoelectronic connector"), which is configured to transmit at least one of power and data between the system console 123 and the catheter 102, and to ensure desired optical connectivity between the energy source 124 and the one or more energy directors 122A of the energy guide bundle 122. Various embodiments of the optoelectronic connector 151 will be described in more detail below. Alternatively, compared to combining Figure 1 Catheter system 100 may include more or fewer components than those specifically shown and described.
[0043] The catheter 102 is configured to be moved to a treatment site 106 within a body 107 of a patient 109 within or adjacent to a vessel wall 108A of a blood vessel 108. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, calcified vascular lesions. Additionally, or alternatively, the treatment site 106 may include a vascular lesion 106A such as a fibrotic vascular lesion. Still alternatively, in some embodiments, the catheter 102 may be used at a treatment site 106 within a body 107 of a patient 109 within or adjacent to a heart valve.
[0044] The catheter 102 may include an expandable 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 the proximal portion 114 of the catheter system 100 to the 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, which is configured to move on the guidewire 112. As used herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may also include an expansion lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal opening 120 and can receive and be tracked by the guidewire 112 when the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the proximal end 104P of the balloon can be coupled to the catheter shaft 110, and the distal end 104D of the balloon can be coupled to the guidewire lumen 118.
[0045] The balloon 104 includes a balloon wall 130 defining a balloon interior 146. The balloon 104 can be selectively inflated using a catheter fluid 132 to expand from a deflated state to an expanded state (eg, Figure 1 ), the deflated state is suitable for advancing the catheter 102 through the patient's vasculature, and the expanded state is suitable for anchoring the catheter 102 in a suitable position relative to the treatment site 106. In another way of stating, when the balloon 104 is in the expanded state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It is to be understood that although Figure 1 The balloon wall 130 of the balloon 104 is shown as being spaced apart from the treatment site 106 of the blood vessel 108 when in the expanded state, but this is done for ease of illustration. It should be appreciated that the balloon wall 130 of the balloon 104 is generally substantially adjacent to and / or abuts the treatment site 106 when the balloon 104 is in the expanded state.
[0046] Balloons 104 suitable for use in the catheter system 100 include those balloons 104 that can pass through the vasculature of the patient 109 when in a deflated state. In some embodiments, the balloon 104 is made of silicone. In other embodiments, the balloon 104 can be made of materials such as polydimethylsiloxane (PDMS), polyurethane, polymers (such as PEBAX™ material), nylon, or any other suitable material.
[0047] The balloon 104 can have any suitable diameter (in the expanded state). In various embodiments, the balloon 104 can have a diameter ranging from less than one millimeter (mm) to up to 25 mm (in the expanded state). Alternatively, the balloon 104 can have another suitable diameter (in the expanded state).
[0048] In various non-exclusive alternative embodiments, the balloon 104 may have a length ranging from at least 3 mm to 300 mm, which may be selected based on the size and / or length of the vascular lesion 106A at the treatment site 106 .
[0049] The balloon 104 can be inflated to an inflation pressure between about one atmosphere (atm) and 70 atm. Alternatively, the balloon 104 can be inflated to other suitable inflation pressures.
[0050] The balloon 104 can have various shapes, including but not limited to a conical shape, a square shape, a rectangular shape, a spherical shape, a conical / square shape, a conical / spherical shape, an extended spherical shape, an elliptical shape, a conical shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or the drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, anti-angiogenic agents, etc.
[0051] The catheter fluid 132 may be a liquid or a gas. Some examples of catheter fluids 132 suitable for use may include, but are not limited to, water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases such as carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 may be used as a base expansion fluid. In some embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium at a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium at a volume ratio of approximately 25:75. In still other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium at a volume ratio of approximately 75:25. However, it is to be understood that any suitable ratio of saline to contrast medium may be used. The catheter fluid 132 may be adjusted in terms of composition, viscosity, etc. so that the propagation rate of the pressure wave is appropriately manipulated. In some embodiments, the catheter fluid 132 suitable for use is biocompatible. The volume of the catheter fluid 132 may be adjusted by the selected energy source 124 and the type of catheter fluid 132 used.
[0052] In some embodiments, the contrast agent used in the contrast media may include, but is not limited to, an iodine-based contrast agent, such as an ionic iodine-based contrast agent or a non-ionic iodine-based contrast agent. In other embodiments, a non-iodine-based contrast agent may be used.
[0053] The catheter fluid 132 may include those catheter fluids that contain absorbents that can selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbents may include those absorbents that have a maximum absorption within the spectrum from at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 may include those fluids that contain absorbents that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbents may be those absorbents that have an absorption maximum that matches the emission maximum of the laser used in the catheter system 100. As non-limiting examples, various lasers that can be used in the catheter system 100 can 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 not water soluble. In some embodiments, the absorber used in the catheter fluid 132 can be adjusted to match the peak emission of the energy source 124.
[0054] The catheter shaft 110 of the catheter 102 can be coupled to one or more energy directors 122A of the energy directing bundle 122, which are in optical communication with the energy source 124 via an optoelectronic connector 151. The energy directors 122A can be disposed along the catheter shaft 110 and within the balloon 104. In some embodiments, each energy director 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 director 122A at the proximal portion 114 of the catheter system 100, such as where the energy director 122A is selectively and mechanically coupled to the system console 123 via the optoelectronic connector 151.
[0055] In some embodiments, the catheter shaft 110 can be coupled to a plurality of energy directors 122A, such as a first energy director, a second energy director, a third energy director, etc., which can be disposed at any suitable location about and / or relative to the guidewire lumen 118 and / or the catheter shaft 110. In certain non-exclusive embodiments, the catheter shaft 110 can be coupled to two energy directors 122A, three energy directors 122A, four energy directors 122A, five energy directors 122A, six energy directors 122A, eight energy directors 122A, or ten energy directors 122A, which can be evenly spaced apart from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Alternatively, the plurality of energy directors 122A need not be evenly spaced apart from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, it will also be appreciated that the energy directors 122A may be disposed uniformly or non-uniformly about the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.
[0056] The catheter system 100 and / or the energy directed bundle 122 may include any number of energy directors 122A in optical communication with the energy source 124 at the proximal portion 114 (via the optoelectronic connector 151) and in optical communication 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 directed bundle 122 may include from one energy director 122A to 30 energy directors 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy directed bundle 122 may include more than 30 energy directors 122A.
[0057] Energy directors 122A may have any suitable design for generating plasma and / or pressure waves in catheter fluid 132 within balloon interior 146. Thus, the general description of energy directors 122A as light directors is not intended to be limiting in any way, except as set forth in the appended claims. More specifically, although catheter system 100 is generally described as energy source 124 being a light source and one or more energy directors 122A being light directors, catheter system 100 may alternatively include any suitable energy source 124 and energy director 122A for generating a desired plasma in catheter fluid 132 within balloon interior 146. For example, in one non-exclusive alternative embodiment, energy source 124 may be configured to provide high voltage pulses, and each energy director 122A may include an electrode pair including spaced apart electrodes extending into balloon interior 146. In such an embodiment, each high voltage pulse is applied to the electrodes and forms an arc across the electrodes, which in turn generates plasma and forms pressure waves in the catheter fluid 132, which are used to provide a disruptive force on the vascular lesion 106A at the treatment site 106. Still alternatively, the energy source 124 and / or the energy director 122A may have another suitable design and / or configuration.
[0058] In some embodiments, energy director 122A may include an optical fiber or a flexible light pipe. Energy director 122A may be thin and flexible and may allow optical signals to be sent with very little intensity loss. Energy director 122A may include a core surrounded by a cladding around its circumference. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of energy director 122A may be formed of one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers. Energy director 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core will be greater than the refractive index of the cladding.
[0059] Each energy director 122A can direct energy along its length from a director proximal end 122P to a director distal end 122D having at least one optical window (not shown) positioned within the balloon interior 146 .
[0060] Energy director 122A can take on many configurations around and / or relative to catheter shaft 110 of catheter 102. In some embodiments, energy director 122A can extend parallel to longitudinal axis 144 of catheter shaft 110. In some embodiments, energy director 122A can be physically coupled to catheter shaft 110. In other embodiments, energy director 122A can be disposed along the length of the outer diameter of catheter shaft 110. In still other embodiments, energy director 122A can be disposed within one or more energy director lumens within catheter shaft 110.
[0061] The energy guides 122A can be positioned at any suitable position about the circumference of 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 relative to the length of the guidewire lumen 118 to more effectively and precisely apply pressure waves for the purpose of destroying vascular lesions 106A at the treatment site 106.
[0062] In some embodiments, energy director 122A may include one or more photoacoustic transducers 154, wherein each photoacoustic transducer 154 may be in optical communication with energy director 122A in which it is disposed. In some embodiments, photoacoustic transducer 154 may be in optical communication with director distal end 122D of energy director 122A. In such embodiments, photoacoustic transducer 154 may have a shape that corresponds to and / or conforms to director distal end 122D of energy director 122A.
[0063] Photoacoustic transducer 154 is configured to convert light energy into acoustic waves at or near distal director end 122D of energy director 122A. The direction of the acoustic waves can be adjusted by changing the angle of distal director end 122D of energy director 122A.
[0064] In some embodiments, the photoacoustic transducer 154 disposed at the guide distal end 122D of the energy guide 122A can take the same shape as the guide distal end 122D of the energy guide 122A. For example, in some non-exclusive embodiments, the photoacoustic transducer 154 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The energy guide 122A can also include additional photoacoustic transducers 154 disposed along one or more side surfaces of the length of the energy guide 122A.
[0065] In some embodiments, energy director 122A may also include one or more steering structures or "diverters" ( Figure 1 The energy guide 122A may be directed toward the balloon wall 130, such as within the energy guide 122A and / or near the guide distal end 122D of the energy guide 122A. Such a steering structure is configured to direct energy from the energy guide 122A away from its axial path and toward a side surface that may be located at or near the guide distal end 122D of the guide 122A before the energy is directed toward the balloon wall 130. Each energy guide 122A may include one or more optical windows disposed along a longitudinal or circumferential surface of each energy guide 122A and in optical communication with the steering structure. The optical window may include a portion of the energy guide 122A that allows energy to exit the energy guide 122A from within the energy guide 122A, such as a portion of the energy guide 122A that is free of cladding material on or around the energy guide 122A.
[0066] Examples of steering structures suitable for use include reflective elements, refractive elements, and fiber optic diffusers. Steering structures suitable for focusing energy away from the tip of energy director 122A may include, but are not limited to, those with convex surfaces, gradient refractive index (GRIN) lenses, and mirror focusing lenses. Upon contact with the steering structure, energy is redirected within energy director 122A to one or more of plasma generator 133 and photoacoustic transducer 154 in optical communication with a side surface and / or optical window of energy director 122A.
[0067] The source manifold 136 can be positioned at or near the proximal portion 114 of the catheter system 100. The source manifold 136 can include one or more proximal openings that can receive the plurality of energy directors 122A of the energy director 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 the catheter fluid 132 as needed.
[0068] As mentioned above, in Figure 1 In the illustrated embodiment, the system console 123 includes one or more of an energy source 124, a power supply 125, a system controller 126, and a GUI 127. Alternatively, the system console 123 may include more Figure 1 127. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Still alternatively, one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 may be disposed at any suitable location within the catheter system 100 without specifically requiring the system console 123.
[0069] As shown, system console 123 and the components it includes are operably coupled to catheter 102, energy directing beam 122, and the rest of catheter system 100. For example, in some embodiments, Figure 1 As shown, system console 123 may include console connection aperture 148 (sometimes also generally referred to as a "socket" or "console socket") through which energy directing beam 122 is mechanically coupled to system console 123. In such embodiments, energy directing beam 122 may include and / or incorporate an optoelectronic connector 151 having a director coupling housing 150 (sometimes also generally referred to as a "connector housing") that houses a portion of each of energy directors 122A, such as director proximal end 122P. At least a portion of director coupling housing 150 is configured to fit and selectively remain within console connection aperture 148 to provide a mechanical coupling between energy directing beam 122 and system console 123.
[0070] As described in more detail below, in various embodiments, optoelectronic connector 151 is configured to ensure proper alignment and coupling of energy directing beam 122 and / or each of one or more energy directors 122A with system console 123, such that energy from energy source 124 is more precisely and accurately directed into director proximal end 122P of each of one or more energy directors 122A before being directed by one or more energy directors 122A into balloon interior 146. In certain embodiments, system console 123 may also be configured to include certain features or components, such as at least one optical sensor 167 (shown in phantom) that may be used in conjunction with at least one actuator 169 (shown in phantom) that further enables precise alignment and coupling of energy beam 122 and / or each of one or more energy directors 122A with system console 123 and / or energy from energy source 124 retained therein.
[0071] As described in further detail below, in many embodiments, the optoelectronic connector 151 is also configured to ensure proper electrical connection between the system console 123 and, therefore, the power supply 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) that is configured to connect to a second electrical connector 465 (e.g., at Figure 4150 and / or adjacent to the guide coupling housing 150, and / or incorporated into the optoelectronic connector 151 to ensure that power and data can be effectively transmitted between the system console 123 and the catheter 102. As described herein, the first electrical connector 163 and the second electrical connector 465 may sometimes be referred to herein individually and / or collectively as an "electrical connection assembly." In some embodiments, the electrical connection assembly may also include a cable 386 (in Figure 3 ), which can be connected to a second electrical connector 465 for further enhancing power and data transmission between the system console 123 and various other components of the catheter system 100.
[0072] It should be understood that referring to 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."
[0073] The energy directing bundle 122 and / or optoelectronic connector 151 may also include a guide bundler 152 (or "cylinder") that provides strain relief as it brings each individual energy director 122A closer together so that the energy directors 122A and / or energy directing bundle 122 may be in a more compact form as it extends into the vessel 108 along with the catheter 102 during use of the catheter system 100.
[0074] Energy source 124 may be selectively and / or alternatively coupled in optical communication with each energy director 122A in energy directed beam 122, such as optically coupled to a director proximal end 122P of each energy director 122A in energy directed beam 122. In particular, energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, which source beam 124A may be selectively and / or alternatively directed to each properly aligned energy director 122A in energy directed beam 122 and received by each properly aligned energy director 122A in energy directed beam 122 as a separate guided beam 124B. Alternatively, catheter system 100 may include more than one energy source 124. For example, in one non-exclusive alternative embodiment, catheter system 100 may include a separate energy source 124 for each energy director 122A in energy directed beam 122.
[0075] Energy source 124 may be of any suitable design. In certain embodiments, energy source 124 may be configured to provide sub-millisecond energy pulses from energy source 124 that are focused onto a small spot so as to couple the energy pulses into guide proximal end 122P of energy guide 122A. Such energy pulses are then directed along energy guide 122A to a location within balloon interior 146 of balloon 104, thereby inducing the formation of plasma in catheter fluid 132 within balloon interior 146 of balloon 104, such as by plasma generator 133, which may be located at or near guide distal end 122D of energy guide 122A. In particular, energy emitted at guide distal end 122D of energy guide 122A is directed toward and incident upon plasma generator 133 and energizes plasma generator 133 to form plasma in catheter fluid 132 within balloon interior 146. The formation of plasma results in rapid formation of bubbles and exerts pressure waves on treatment site 106. Exemplary plasma induced bubbles 134 in Figure 1 is shown in .
[0076] In various non-exclusive embodiments, sub-millisecond energy pulses from energy source 124 may be delivered to treatment site 106 at a frequency 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 energy pulses may be delivered to treatment site 106 at a frequency that may be greater than 5000 Hz or less than 1 Hz, or any suitable frequency range.
[0077] It is to be understood that while the energy source 124 is typically utilized to provide pulses of energy, the energy source 124 may still be described as providing a single source beam 124A, such as a single pulsed source beam.
[0078] Energy sources 124 suitable for use may include various types of light sources, including lasers and lamps. Alternatively, energy source 124 may include any suitable type of energy source.
[0079] Suitable lasers may include short pulse lasers on a sub-millisecond time scale. In some embodiments, energy source 124 may include a laser on a nanosecond (ns) time scale. Lasers may also include short pulse lasers on picosecond (ps), femtosecond (fs) and microsecond (us) time scales. It is to be understood that many combinations of laser wavelength, pulse width and energy level may be used to realize plasma in the conduit fluid 132 of conduit 102. In various non-exclusive alternative embodiments, pulse width may include those pulse widths falling within a range including from at least 10ns to 3000ns, from at least 20ns to 100ns, or from at least 1ns to 500ns. Alternatively, any other suitable pulse width range may be used.
[0080] Exemplary nanosecond lasers may include those with wavelengths ranging from approximately 10 nanometers (nm) to 1 millimeter (mm) within the UV to IR spectrum. In some embodiments, an energy source 124 suitable for use in the catheter system 100 may include a light source capable of generating light with a wavelength from at least 750nm to 2000nm. In other embodiments, the energy source 124 may include a light source capable of generating light with a wavelength from at least 700nm to 3000nm. In still other embodiments, the energy source 124 may include a light source capable of generating light with a wavelength from at least 100nm to 10 micrometers (μm). Nanosecond lasers may include those lasers with a repetition rate of up to 200kHz.
[0081] In some embodiments, the laser may include a Q-switched thulium:yttrium aluminum garnet (Tm:YAG) laser. In other embodiments, the laser may include a neodymium:yttrium aluminum garnet (Nd:YAG) laser, a holmium:yttrium aluminum garnet (Ho:YAG) laser, an erbium:yttrium aluminum garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped laser, a pulsed laser, or a fiber laser.
[0082] In still other embodiments, the energy source 124 may include multiple lasers grouped together in series. In still other embodiments, the energy source 124 may include one or more low energy lasers fed into a high energy amplifier such as a master oscillator power amplifier (MOPA). In still other embodiments, the energy source 124 may include multiple lasers that may be combined in parallel or in series to provide the energy required to generate a plasma bubble 134 in the conduit fluid 132.
[0083] The catheter system 100 can generate pressure waves having a maximum pressure in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 will depend on the energy source 124, the absorbent material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive embodiments, the catheter system 100 can generate pressure waves having a maximum pressure in the range of at least about 2 MPa to 50 MPa, at least about 2 MPa to 30 MPa, or at least about 15 MPa to 25 MPa.
[0084] When catheter 102 is placed at treatment site 106, pressure waves may be applied to treatment site 106 from a distance in the range of at least about 0.1 millimeter (mm) to greater than about 25 mm extending radially from energy director 122A. In various non-exclusive embodiments, when catheter 102 is placed at treatment site 106, pressure waves may be applied to treatment site 106 from a distance in the range of 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 energy director 122A. In other embodiments, pressure waves may be applied to treatment site 106 from another suitable distance different from the foregoing ranges. In some embodiments, pressure waves in the range of at least about 2 MPa to 30 MPa may be applied to treatment site 106 at a distance from at least about 0.1 mm to 10 mm. In some embodiments, pressure waves within a range of at least about 2 MPa to 25 MPa may be applied to treatment site 106 at a distance from at least about 0.1 mm to 10 mm. Still alternatively, other suitable pressure ranges and distances may be used.
[0085] The power supply 125 is electrically coupled to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128, and is configured to provide necessary power to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128. The power supply 125 may have any suitable design for these purposes.
[0086] The system controller 126 is electrically coupled to the power source 125 and receives power from the power source 125. The system controller 126 is coupled to each of the energy source 124 and the GUI 127 and is configured to control the operation of each of the energy source 124 and the GUI 127. The system controller 126 may include one or more processors or circuits for controlling the operation of at least the energy source 124 and the GUI 127. For example, the system controller 126 may control the energy source 124 to generate energy pulses as desired, and / or generate energy pulses at any desired firing rate.
[0087] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as positioning of the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 using the catheter fluid 132, etc. Additionally or alternatively, the catheter system 100 may include one or more additional controllers, which may be positioned in any suitable manner, for controlling various operations of the catheter system 100. For example, in some embodiments, the additional controllers and / or a portion of the system controller 126 may be positioned and / or contained within the handle assembly 128.
[0088] GUI 127 is accessible by a user or operator of catheter system 100. GUI 127 is electrically connected to system controller 126. By such a design, a user or operator can use GUI 127 to ensure that catheter system 100 is effectively utilized to apply pressure to vascular lesions 106A at treatment site 106 and induce fractures in vascular lesions. GUI 127 can provide information to a user or operator that can be used before, during, and after using catheter system 100. In one embodiment, GUI 127 can provide static visual data and / or information to a user or operator. In addition, or alternatively, during the use of catheter system 100, GUI 127 can provide dynamic visual data and / or information to a user or operator, such as video data or any other data that changes over time. In various embodiments, GUI 127 can include one or more colors, different sizes, varying brightness, etc. that can be used as an alarm to a user or operator. In addition, or alternatively, GUI 127 can provide audio data or information to a user or operator. The details of GUI 127 may vary depending on the design requirements of catheter system 100 or the specific needs, specifications, and / or desires of a user or operator.
[0089] like Figure 1 As shown, the handle assembly 128 can be positioned 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 positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be positioned at another suitable location.
[0090] The handle assembly 128 is attached to the catheter shaft 110 and is handled and used by a user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. Figure 1 In the illustrated embodiment, the handle assembly 128 is separate from one or more of the system controller 126 , the energy source 124 , the fluid pump 138 , and the GUI 127 , but is in electrical and / or fluid communication therewith.
[0091] In some embodiments, the handle assembly 128 may integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in some such embodiments, the handle assembly 128 may include a circuit 156 that is electrically coupled between the catheter electronics and the system console 123 and may form at least a portion of the system controller 126. In one embodiment, the circuit 156 may include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In alternative embodiments, the circuit 156 may be omitted, or may be included within the system controller 126, which in various embodiments may be located external to the handle assembly 128, for example, within the system console 123. It is to be understood that the handle assembly 128 may include fewer or more components than specifically shown and described herein.
[0092] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.
[0093] As with all embodiments shown and described herein, various structures may be omitted from the drawings for clarity and ease of understanding. In addition, the drawings may include certain structures that may be omitted without departing from the intent and scope of the present invention.
[0094] Figure 2 is a simplified perspective view of an embodiment of an optoelectronic connector assembly 251 having features of the present invention, which may be included as Figure 1 Part of the catheter system 100.
[0095] The design of the optoelectronic connector 251 can vary. As shown in the figure, Figure 2 Various external components and features are shown that may be included in various embodiments of the optoelectronic connector 251. Specifically, as shown, the optoelectronic connector 251 may include one or more of a guide coupling (or connector) housing 250, a guide strapper 252, a sealing member 260, a contaminant inhibitor 262, and a locking mechanism 264. Alternatively, the optoelectronic connector 251 may include more or fewer external components than those specifically noted.
[0096] One of the main purposes of the optoelectronic connector 251 is to provide a ferrule 366 to be located therein (e.g., Figure 3 ) and thus the energy director 122A (shown in Figure 1 ) is connected to the console connection hole 148 (or "console socket", in Figure 1Thus, the optoelectronic connector 251 and the ferrule 366 and energy director 122A at least partially retained therein are located in the system console 123 (in Figure 1 ) in the console connection hole 148 more precisely connected and aligned, from the energy source 124 (in Figure 1 Energy of the energy director 122A may be effectively and selectively coupled to each of the one or more energy directors 122A.
[0097] Another primary purpose of the optoelectronic connector 251 is to ensure that a proper electrical connection is established between the system console 123 and the rest of the catheter system 100. Specifically, in various embodiments, the system console 123 may include a first electrical connector 163 (at Figure 1 ), and the optoelectronic connector 251 may include a second electrical connector 465 (e.g., Figure 4 ), the first electrical connector and the second electrical connector are configured to dock with each other to ensure that power and data can be connected between the system console 123 and the catheter 102 (in Figure 1 It should be understood that the first electrical connector 163 and the second electrical connector 465 can have any suitable design to effectively ensure that power and data can be effectively transmitted between the system console 123 and the catheter 102.
[0098] In various embodiments, the optoelectronic connector 251 and / or the system console 123 (at Figure 1 ) may include certain features or components to better ensure a more precisely aligned connection therebetween. For example, in some embodiments, the optoelectronic connector 251 may include (i) a ferrule 366 having a positioning hole 576 (in Figure 5 The ferrule housing 370 shown in FIG. Figure 3 (ii) the ferrule housing 370 is allowed to float relative to the guide coupling housing 250 by selectively moving (up and down and / or left and right) relative to the guide coupling housing 250 as needed; and (iii) the position compensator 374 (in Figure 3 ), which is configured to provide a spring force to maintain the ferrule 366 in an aligned position while still allowing play within the ferrule housing 370; and (iv) a resilient plate 372 (in Figure 3 ), which is configured to control the float of the collar housing 370 within the guide coupling housing 250. In some embodiments, the system console 123 may include one or more optical sensors 167 (in Figure 1 ), which is configured to sense the position of the optoelectronic connector 251 and / or the guide coupling housing 250 relative to the system console 123 and / or the console connection hole 148. Based on the sensed position of the optoelectronic connector 251 and / or the guide coupling housing 250 relative to the system console 123 and / or the console connection hole 148, the actuator 169 can then be activated (at Figure 1 ), the actuator 169 mechanically pulls the optoelectronic connector 251 precisely into the appropriate position within the console connection hole 148.
[0099] The guide coupling housing 250 is configured to receive a portion of each of the energy directors 122A, such as the guide proximal end 122P, and is adapted and selectively retained within the console connection aperture 148 to provide energy guide beam 122 (at Figure 1 ) and the system console 123. The design of the introducer coupling housing 250 can be varied to accommodate the requirements of the catheter system 100 and / or the optoelectronic connector 251. In certain embodiments, the introducer coupling housing 250 can be formed of a plurality of housing members (such as a first housing member 250A and a second housing member 250B) that can be selectively coupled together to effectively retain the various internal components of the optoelectronic connector 251 within the housing cavity 368 defined therein (in Figure 3 ). In one embodiment, each of the first shell member 250A and the second shell member 250B can form half of the guide coupling housing 250 (such as an upper half and a corresponding lower half in a non-exclusive embodiment), wherein each half is substantially similar to the other half. It should be understood that the housing members 250A, 250B can be selectively coupled together in any suitable manner. Alternatively, the guide coupling housing 250 can have another suitable design. For example, in certain alternative embodiments, the guide coupling housing 250 can have more than two housing members or only a single housing member.
[0100] It should be understood that the guide coupling housing 250 and / or the individual housing members 250A, 250B may be formed of any suitable material that provides an effective housing to protect the various internal components held therein. Figure 3 Various internal components of optoelectronic connector 251 are shown and described.
[0101] Guide bundle 252 is configured to provide strain relief as it brings each of the individual energy directors 122A closer together so that energy directors 122A and / or energy guiding bundle 122 can be moved more freely as they move through catheter system 100 (at Figure 1 ) during use with the catheter 102 (in Figure 1) together with the blood vessel 108 in a more compact form. Figure 3 Certain internal components that may be included within director strap 252 are shown and described for providing strain relief as director strap 252 brings energy directors 122A closer together within energy directing bundle 122 .
[0102] During use of the catheter system 100, it is desirable to limit the amount of dust and other particles that might otherwise contaminate the proximal end 122P (at the distal end) of each of the one or more energy directors 122A. Figure 1 ) of the guide surface.
[0103] The sealing member 260 is configured to seal the connection between the optoelectronic connector 251 and the system console 123 when the guide coupling housing 250 is inserted into the console connection hole 148 and selectively retained in the console connection hole 148. With this design, the sealing member 260, which can be provided in the form of a face gasket in a non-exclusive embodiment, 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 coupling 252. In some embodiments, the sealing member 260 can be formed of an elastic material that can effectively provide a sealed connection between the guide coupling housing 250 and the console connection hole 148. Alternatively, the sealing member 260 can be formed of another suitable material.
[0104] Contaminant suppressor 262 is similarly configured to limit the amount of dust or other particles that might otherwise contaminate the director face of each of the one or more energy directors 122A. More specifically, as shown, contaminant suppressor 262 can be configured to be positioned around and / or adjacent a portion of director coupling housing 250 within which collar 366, and therefore the director proximal end 122P of each energy director 122A, is retained. Contaminant suppressor 262 can have any suitable design that is configured to inhibit the introduction of dust and other particles into director coupling housing 250 while still allowing energy from energy source 124 to couple to the director proximal end 122P of each of the one or more energy directors 122A.
[0105] In some embodiments, contamination inhibitor 262 can be disposable, such that when it is sufficiently contaminated with dust and other particles, contamination inhibitor 262 can be simply thrown away. In other embodiments, contamination inhibitor 262 can be reusable, such that it can be selectively removed from guide coupling housing 250 and cleaned, and then selectively coupled to guide coupling housing 250 again for additional use.
[0106] The locking mechanism 264 is configured to selectively lock the optoelectronic connector 251 in place when the optoelectronic connector 251 is coupled to the console connection hole 148. More specifically, during use of the catheter system 100, when the optoelectronic connector 251 is inserted into the console connection hole 148 of the system console 123, the optical sensor 167 registers it and activates the actuator 169, which mechanically pulls the optoelectronic connector 251 into place and locks it in place. The locking mechanism 264 provides an effective means to lock the optoelectronic connector 251 in a position where the optoelectronic connector 251 has been inserted into the console connection hole 148 so that it can be selectively and securely retained therein.
[0107] Figure 3 yes Figure 2 A simplified top view of a portion of the optoelectronic connector 251 is shown. More specifically, Figure 3 Various internal components and features that may be included in various embodiments of optoelectronic connector 251 are shown. Figure 3 As shown, in various embodiments, the optoelectronic connector 251 may include one or more of a plurality of ferrules 366, a ferrule housing 370, a portion of one or more energy directors 322A, an elastic plate 372, at least one position compensator 374 (such as a silicone gasket in a non-exclusive embodiment), and at least a portion of the director bundler 252 within the director coupling housing 250. It should be understood that in Figure 3 Only the second housing member 250B of the guide coupling housing 250 is visible, so that the other described components can be clearly seen to be positioned within the housing cavity 368 defined within the guide coupling housing 250 and / or within the guide strapper 252.
[0108] As used herein, a "ferrule" is a component of an optical fiber used to protect and align the stripped end of an energy director 322A (or optical fiber). During use, the energy director 322A can be inserted into a thin structure of a ferrule 366 and can be provided with an adhesive (not shown) to prevent contamination and to impart long-term mechanical strength. The ferrule 366 can be formed of any suitable material in order to provide the desired contamination protection and enhanced long-term mechanical strength to the stripped director proximal end 322P of the energy director 322A.
[0109] According to the optical connection to ( Figure 1 Depending on the number of energy directors 322A of the energy source 124 (shown in FIG. 1 ), the optoelectronic connector 251 may include any suitable number of ferrules 366 within the housing cavity 368 defined by the director coupling housing 250. For example, in one non-exclusive embodiment, as shown in FIG. Figure 3As shown, optoelectronic connector 251 may include ten ferrules 366, each ferrule 366 being configured to hold and protect a portion of one or more energy directors 322A, such as director proximal end 322P. Thus, in such an embodiment, energy directing beam 322 may include up to ten energy directors 322A. Alternatively, optoelectronic connector 251 may include more than ten or less than ten ferrules 366.
[0110] like Figure 3 As further shown in FIG. 2 , in some embodiments, ferrule 366 is positioned within director coupling housing 250 in a manner such that ferrule 366 is recessed relative to console facing side 382 of director coupling housing 250. With ferrule 366 recessed from console facing side 382 of director coupling housing 250, optoelectronic connector 251 is configured to help ensure that fingers or other objects do not contact the face of energy director 322A at director proximal end 322P of energy director 322A, which could otherwise result in undesirable contamination.
[0111] Depending on the specific design requirements of optoelectronic connector 251 and / or catheter system 100 , ferrule 366 may be recessed any desired distance from console-facing side 382 of introducer coupling housing 250 .
[0112] Collar housing 370 is configured to provide a housing for collars 366 so that collars 366 can be collectively moved and positioned relative to energy from energy source 124. Collar housing 370 also enables collars 366 to be maintained at a desired distance from one another so that the director proximal end 322P of each energy director 322A can be properly aligned to accurately receive energy from energy source 124. Figure 1 The console connection hole 148 (shown in Figure 1 ), that is, Figure 3 322A, the face of the collar 366 is exposed. In certain embodiments, the collar 366 is allowed to float significantly within and / or relative to the collar housing 370, and the collar housing 370 is allowed to float within and / or relative to the guide coupling housing 250 to allow the collar 366, and therefore the guide proximal end 322P of the energy director 322A, to be easily and accurately adjusted to more accurately align with the console connection hole 148 of the system console 123.
[0113] The resilient plate 372, such as a spring plate in certain embodiments, is configured to control the floatation of the ferrule housing 370 within and / or relative to the guide coupling housing 250. More specifically, when the ferrule housing 370 is allowed to float within the guide coupling housing 250, it is desirable that the ferrule housing 370 not just loosely float uncontrollably within the guide coupling housing 250. The resilient plate 372 provides a biasing force that allows the ferrule housing 370 to float within the guide coupling housing 250 while enabling the ferrule housing 370 to be resiliently maintained in place within the guide coupling housing 250 once the desired positioning is accurately determined.
[0114] At least one position compensator 374, such as a silicone washer in certain non-exclusive embodiments, is configured to provide a spring force to hold the ferrule 366 in an aligned position while still allowing play within the ferrule housing 370. However, if the ferrule housing 370 needs to be adjusted to accommodate the fit of the ferrule 366 relative to the console connection aperture 148 and / or energy from the energy source 124, the ferrule housing 370 can be moved to accommodate such an adjusted position. Without the at least one position compensator 374, the ferrule 366 may become stuck with the console connection aperture 148 due to mating interference.
[0115] The optoelectronic connector 251 may include any suitable number of position compensators 374. For example, in one non-exclusive embodiment, the optoelectronic connector 251 may include four position compensators 374. Alternatively, in other embodiments, the optoelectronic connector 251 may include more than four or less than four position compensators 374.
[0116] As described above, guide bundle 252 is configured to provide strain relief as it brings each of the individual energy directors 322A closer together so that energy directors 322A and / or energy guiding bundles 322 can be moved more freely as they move through catheter system 100 (at Figure 1 ) during use with the catheter 102 (in Figure 1 ) together with the blood vessel 108 (shown in Figure 1 The design of the guide strapping device 252 can vary. For example, Figure 3 As shown, in some embodiments, the introducer strapping device 252 may include a sleeve 378, when the energy guide beam 322 is directed toward the balloon 104 (such as Figure 1 When the energy directors 322A are extended (as shown), a portion of all energy directors 322A is retained within the sleeve 378. The director bundler 252 may also include a locking crimp 380 configured to tightly gather the energy directors together to form the energy director bundle 322 in a controlled manner.
[0117] As shown in the figure, Figure 3 Also shown is the path of energy director 322A as it extends through director coupling housing 250 of optoelectronic connector 251. More specifically, director proximal end 322P of each of energy directors 322A is positioned proximate console connection aperture 148 of director coupling housing 250 that faces system console 123 (at Figure 1 378) with energy directors 322A positioned at a desired spacing relative to each other. Energy directors 322A then extend through director coupling housing 250 to where they are drawn together or bundled together at director bundler 252. Energy director bundle 322 then extends toward balloon 104 along with catheter 102 with a portion of energy director 322A positioned within sleeve 378.
[0118] In certain embodiments, such as Figure 3 As shown, energy director 322A may include service loop 322L. Movement of energy director 322A throughout catheter system 100 may result in alternating periods of slack and tension on energy director 322A, which may result in axial and longitudinal movement of the director and cable. Such movement may result in undesired squeezing and / or twisting of energy director 322A of catheter system 300, and may result in degradation of energy director 322A. Thus, including service loop 322L may help inhibit any undesired squeezing and / or twisting of energy director 322A, as service loop 322L helps minimize alternating periods of slack and tension on energy director 322A.
[0119] In some embodiments, as shown, service loop 322L may wrap around service loop director 384. For example, in certain non-exclusive embodiments, energy director 322A may wrap around service loop director 384 greater than about 5 degrees and less than about 1080 degrees. More specifically, energy director 322A may surround service loop director 384 by 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, 195 degrees, 200 degrees, 205 degrees, 210 degrees, 215 degrees, 220 degrees, 0 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 5 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, 970 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, energy director 322A may surround service ring director 384 in an annulus less than about 5 degrees or greater than about 1080 degrees.
[0120] The service loop guide 384 can guide at least one of movement and positioning of the energy director 322A within the optoelectronic 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 optoelectronic connector 251. Figure 3 As shown, service loop 322L includes a portion of energy director 322A to reduce mechanical strain and / or mechanical forces that may impact energy director 322A.
[0121] Service loop director 384 may cooperate with director bundle 252 so that a user may service energy director 322A. For example, director bundle 252 may be at least partially removable to expose energy director 322A and / or service loop 322L so that an operator may maintain, repair, and / or remove energy director 322A (or any other component of optoelectronic connector 251).
[0122] Service loop guide 384 and guide bundler 252 can cooperate to (i) provide storage area for energy guides 322A and / or (ii) keep energy guides 322A organized. The details of service loop guide 384 can vary depending on the design requirements of catheter system 100, optoelectronic connector 251, and / or the specific needs, specifications, and / or desires of a user or operator.
[0123] Service loop director 384 may locate components such as energy director 322A and / or service loop 322L. For example, Figure 3 As shown, the service loop guide 384 can position the service loop 322L portion of the energy director 322A in a slightly circular pattern. It should be understood that the service loop guide 384 can take the form of any suitable geometric structure, and the service loop guide 384 is preferably arranged in a circular pattern. Figure 3322A, so that the portion can form a loop (e.g., service loop 322L) around service loop guide 384. Service loop guide 384 can be configured so that the guide distal end 122D (at the end of each energy guide 322A) of each energy guide 322A is Figure 1 ) is capable of moving relative to the optoelectronic connector 251.
[0124] In certain embodiments, service loop director 384 increases the likelihood that a portion of energy director 322A (e.g., service loop 322L) remains in an annular orientation so that tension or axial movement experienced by energy director 322A does not cause energy director 322A to kink or otherwise bend at an undesirable angle. This reduces the likelihood of damaging energy director 322A.
[0125] Service loop guide 384 may include a post or other structure having a width to maintain the spacing or diameter of a portion of energy director 322A located within service loop 322L. The width of service loop guide 384 may be greater than the minimum bend or kink radius of energy director 322A, which may depend on the specific material from which energy director 322A is constructed.
[0126] In some embodiments, service loop guide 384 may include a guide receiver (not shown) for receiving a portion of energy guide 322A to position energy guide 322A toward handle assembly 128. Guide receiver may be displaced from a portion of service loop guide 384 that energy guide 322A surrounds to provide spacing between energy guides 322A within guide strap 252.
[0127] For example, the service loop guide 384 may include a channel, groove, recess, hole, or the like in the body of the service loop guide 384. Although not shown, the service loop guide 384 may include multiple paths for additional energy directors 322A and / or cables 386 coupled to the optoelectronic connector 251 to help manage and locate the length through the catheter system 100, thereby reducing the possibility of tangling, kinking, etc. The cable 386 may connect the various portions of the handle assembly 128 and / or optoelectronic connector 251 to any suitable power source (such as Figure 1 The power supply 125 shown in FIG.
[0128] In other embodiments, catheter system 100 may omit service loop guide 384 and energy director 322A may form one or more loops, such as service loop 322L, to provide additional length at guide distal end 122D only when needed.
[0129] like Figure 3 In the illustrated embodiment, the optoelectronic connector 251 also includes a second electrical connector 465 (shown in dashed lines and in Figure 4 ), which is configured to connect to the first electrical connector 163 (in the system console 123) Figure 1 102) so that power and data can be efficiently transmitted between the system console 123 and the catheter 102. As described above, the electrical connection assembly including the first electrical connector 163 and / or the second electrical connector 465 can also include a cable 386, which is electrically connected to the second electrical connector 465 to more efficiently transmit power and data between the system console 123 and various other components of the catheter system 100 (such as the catheter 102) as needed.
[0130] Figure 4 yes Figure 2 A simplified bottom view of the optoelectronic connector 251 is shown. More specifically, Figure 4 is a simplified bottom view illustration of the optoelectronic connector 251 showing the guide coupling housing 250 , the guide strap 252 , and the second electrical connector 465 positioned within and / or adjacent to the guide coupling housing 250 .
[0131] As shown, the second electrical connector 465 is configured to be connected to the system console 123 ( Figure 1 ) in the first electrical connector 163 ( Figure 1 ) to ensure that when the optoelectronic connector 251 is mechanically coupled to the system console 123, power and / or data are transferred between the system console 123 and the catheter 102 ( Figure 1 ) between them.
[0132] The second electrical connector 465 can have any suitable design for docking with the first electrical connector 163. For example, in a non-exclusive embodiment, Figure 4As shown, the second electrical connector 465 may include a connector base 465A (such as in the form of a printed circuit board), and a plurality of electrical connection (conductive) pads 465B coupled to and / or mounted on the connector base 465A. Each of the plurality of electrical connection pads 465B is configured to dock 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 inhibit unintentional contact with the electrical connection pads 465B, such as by fingers, during use and manipulation of the optoelectronic connector 251. In addition, the size and / or spacing of the electrical connection pads 465B may also be configured so that fingers of typical size are too large to directly approach and contact the electrical connection pads 465B within the recess. In addition, the fingers will typically contact the connector base 465A on either side of the recess instead. Alternatively, the second electrical connector 465 may have another suitable design, which may also be configured to inhibit unintentional contact with the electrical connection pads 465B. Still alternatively, the second electrical connector 465 may be different from Figure 4 Another suitable way of positioning is as specifically shown in FIG.
[0133] 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, Figure 4 As shown, the second electrical connector 465 may include five electrical connection pads 465B that are coupled to, mounted on, and / or recessed in the connector base 465A. Alternatively, the second electrical connector 465 may include more than five or less than five electrical connection pads 465B that are coupled to, mounted on, and / or recessed in the connector base 465A.
[0134] Figure 5 yes Figure 2 A simplified end view of the optoelectronic connector 251 is shown in FIG. More specifically, Figure 5 The face 566F of each ferrule 366 is shown when the ferrule 366 is retained in a generally spaced-apart desired position within the ferrule housing 370. In some embodiments, as shown, the ferrule 366 is positioned within a locating hole 576 formed in the ferrule housing 370. As shown, the locating hole 576 can be sized to have a tolerance that allows the ferrule 366 to fit loosely within the locating hole 576. In other words, in some embodiments, the locating hole 576 is slightly larger than the diameter of the ferrule 366 to allow the ferrule 366 to move relative to the ferrule housing 370. With this design, as noted, the ferrule 366 is allowed to float significantly within the ferrule housing 370 to allow for the optical connector 251 to be positioned within the system console 123 (at Figure 1The console connection hole 148 (shown in Figure 1 ) when the ferrule 366 and thus the energy director 322A (in Figure 3 The guide proximal end 322P (shown in Figure 3 ) more accurately corresponds to the energy source 124 (in Figure 1 Energy alignment of the ).
[0135] As the optoelectronic connector 251 is advanced into the console connection hole 148, the ferrules 366 find their position in the console connection hole 148 due to the chamfered lead-in on the console connection hole 148. This allows the tight tolerance on the console connection hole 148 and the tight tolerance outer diameter of the ferrule 366 to drive fit.
[0136] In various embodiments, the ferrule housing 370 can also be selectively positionable within the guide coupling housing 250 to better achieve a desired alignment between the energy directors 322A and the energy from the energy source 124. In other words, in addition to the loose fit between the ferrule 366 and the locating hole 576 in the ferrule housing 370, the ferrule housing 370 is allowed to float (up and down and / or left and right) within the assembled guide coupling housing 250. With this design, the ability to accurately and precisely position the guide proximal end 322P of each of the energy directors 322A relative to the energy from the energy source 124 is further enhanced.
[0137] Figure 6 6 is a simplified top view of a portion of another embodiment of an optoelectronic connector assembly 651. As shown, the optoelectronic connector 651 is substantially similar to the embodiment of the optoelectronic connector 251 shown and described above. Figure 6 As shown, the optoelectronic connector 651 again includes a guide coupling housing 650, a guide binder 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 above. Therefore, these components will not be described in detail. It should be understood that the optoelectronic connector 651 can and most likely also include a sealing member 260 (at Figure 2 ), contaminant suppressor 262 (in Figure 2 ) and the locking mechanism 264 (shown in Figure 2 ), although these components are Figure 6 Not shown.
[0138] However, in this embodiment, energy director bundle 622 and / or energy director 622A do not include service loop 322L because energy director 622A is routed through director coupling housing 650 and / or director strapping 652 of optoelectronic connector 651. Therefore, the routing of energy director 622A through optoelectronic connector 651 is somewhat different than the routing in the previous embodiment without forming service loop 322L within optoelectronic connector 651. Specifically, as shown, when energy director 622A extends through director coupling housing 650 and director strapping 652 of optoelectronic connector 651, the routing of energy director 622A includes positioning director proximal end 622P of each of energy directors 622A proximate console connection hole 148 of director coupling housing 650 that faces system console 123 (at Figure 1 666 on one side of the guide housing 650, wherein the energy directors 622A are positioned at a desired spacing relative to each other. The energy directors 622A then extend through the guide coupling housing 650 to where they are drawn together or bundled together at the guide bundler 652. The energy directing bundle 622 (with the energy directors 622A positioned within the sleeve 678) is then coupled to the catheter 102 (at Figure 1 ) together toward the balloon 104 (in Figure 1 ) extension.
[0139] Fig. 7A 751 is a simplified top perspective view of a portion of another embodiment of an optoelectronic connector assembly 751. Specifically, Fig. 7A 7 is a simplified top perspective view of an embodiment of a portion of the guide coupling housing 750 (i.e., the second housing member 750B), the guide binder 752, and a second electrical connector 765 positioned within and / or adjacent to the guide coupling housing 750. In this embodiment, the design of the second electrical connector 765 is somewhat different from the embodiments shown and described above.
[0140] As shown, the second electrical connector 765 is again configured to be connected to a second electrical connector located at the system console 123 ( Figure 1 ) in the first electrical connector 163 ( Figure 1 ) to ensure that when the optoelectronic connector 751 is mechanically coupled to the system console 123, power and / or data are transferred between the system console 123 and the catheter 102 ( Figure 1 ) between them.
[0141] like Fig. 7AAs shown, the second electrical connector 765 again includes a connector base 765A (such as in the form of a printed circuit board) and a plurality of electrical connection pads 765B that are coupled to and / or mounted on the connector base 765A and are configured to interface with corresponding electrical connection components included as part of the first electrical connector 163. It should again be understood that the second electrical connector 765 can include any suitable number of electrical connection pads 765B, wherein the number of electrical connection pads 765B again generally corresponds to the number of corresponding electrical connection components included as part of the first electrical connector 163.
[0142] Figure 7B yes Fig. 7A 751 is a simplified bottom view of a portion of the optoelectronic connector assembly 751 shown in FIG. More specifically, Figure 7B yes Fig. 7A 7 is a simplified bottom perspective view of a portion of the guide coupling housing 750 shown in , namely the second housing member 750B, the guide strap 752 and the second electrical connector 765 positioned within and / or adjacent to the guide coupling housing 750 .
[0143] like Figure 7B As shown, the second electrical connector 765 is positioned within a recessed area 790 formed into the second housing member 750B. As further shown, a plurality of spacers 792 are included that extend generally away from the surface of the second housing member 750B within the recessed area 790. The spacers 792 are positioned between the electrical connection pads 765B of the second electrical connector 765. The size and shape of the spacers 792 and the spacing between the electrical connection pads 765B of the second electrical connector 765 are specifically designed to inhibit, for example, the passage of the catheter system 100 (in the case of the optical connector 751) during use and manipulation of the optical connector 751. Figure 1 Thus, with this design, the electrical connection pad 765B of the second electrical connector 765 is effectively recessed relative to the entire surface of the second housing member 750B in a manner that protects the integrity of the electrical connection pad 765B, while still achieving the desired docking between the electrical connection pad 765B of the second electrical connector 765 and a corresponding electrical connection component included as part of the first electrical connector 163.
[0144] The present technology also relates to methods for treating a treatment site within or adjacent to a vessel wall that utilize the devices disclosed herein.
[0145] In summary, based on various embodiments of the present invention shown and described in detail herein, catheter systems and related methods can include a catheter configured to be advanced to a vascular lesion, such as a calcified vascular lesion or a fibrous vascular lesion, at a treatment site within a blood vessel or adjacent to a blood vessel in a patient's body. The catheter includes a catheter shaft and an expandable balloon connected and / or fixed to the catheter shaft. The balloon may include a balloon wall defining an interior of the balloon. The balloon may be configured to receive a catheter fluid within the balloon interior to expand from a contracted state suitable for advancing the catheter through the patient's vascular system to an expanded state suitable for anchoring the catheter in a suitable position relative to the treatment site.
[0146] In certain embodiments, catheter systems and related methods utilize an energy source, such as a light source (such as a laser source or another suitable energy source), that provides energy directed by one or more energy directors (e.g., light directors such as optical fibers) disposed along the catheter shaft and disposed within the balloon interior of the balloon to generate a localized plasma in the catheter fluid retained within the balloon interior of the balloon. The energy directors may be used in conjunction with a plasma generator positioned at or near a director distal end of the energy director, the director distal end of the energy director being within the balloon interior of the balloon at the treatment site. The generation of the localized plasma may induce pressure waves and may induce the rapid formation of one or more bubbles that may rapidly expand to a maximum size and then dissipate through a cavitation event that may emit pressure waves upon collapse. The rapid expansion of the plasma-induced bubbles (sometimes also referred to simply as "plasma bubbles") may generate one or more pressure waves within the catheter fluid retained within the balloon interior of the balloon, thereby applying the pressure waves to and inducing rupture of vascular lesions at the treatment site within or adjacent to the vessel wall within the patient's body. In some embodiments, the energy source can be configured to provide sub-millisecond energy pulses, such as light energy, to induce plasma formation in the catheter fluid within the balloon, thereby causing rapid bubble formation and exerting pressure waves on the balloon wall at the treatment site. Thus, the pressure waves can transfer mechanical energy to the treatment site through the incompressible catheter fluid, thereby exerting a fracture force on the intravascular lesion. Without wishing to be bound by any particular theory, it is believed that the rapid change in momentum of the catheter fluid on the balloon wall in contact with the intravascular lesion is transferred to the intravascular lesion, inducing fracture of the lesion.
[0147] Importantly, the catheter systems and related methods disclosed herein also include: optoelectronic connectors configured to ensure proper alignment and connection of ferrules that each retain a portion of one of the one or more energy directors to a system console that can 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, by using optoelectronic connectors having features of the present invention, one or more energy directors can be properly aligned within a console connection aperture of a system console so that energy from the energy source is more precisely and accurately directed into the proximal end of each of the one or more energy directors before being directed by the one or more energy directors into the interior of the balloon. In various embodiments, the optoelectronic connectors can be further configured to ensure that the director face at the proximal end of the energy director (into which energy from the energy source is directed) is substantially free of dust and particles that might otherwise contaminate the director face.
[0148] In many embodiments, the optoelectronic connector is also configured to ensure that an appropriate electrical connection is established between the system console and the catheter so that power and data can be effectively transmitted between the system console and the catheter. More specifically, an electrical connector integrated as part of the optoelectronic connector is configured to dock with a corresponding electrical connector within the system console to ensure that power and data can be effectively transmitted between the system console and the catheter.
[0149] 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 dictate 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.
[0150] It should also be noted that, as used in this specification and the appended claims, the phrase "configured" describes a system, device, or other structure that is constructed or configured to perform a specific task or adopt a specific configuration. The phrase "configured" may be used interchangeably with other similar phrases, such as arrange and configure, construct and arrange, construct, manufacture, and arrange, etc.
[0151] It is to be appreciated that the drawings shown and described are not necessarily drawn to scale and that they are provided for ease of reference and understanding and for relative positioning of structures.
[0152] The headings used herein are intended to be consistent with the recommendations under 37 CFR § 1.77, or to otherwise provide organizational cues. These headings should not be considered to limit or characterize the invention(s) listed in any claims that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that the technology is prior art to any invention in this disclosure. Nor can an "Overview" or "Abstract" be considered to characterize the invention(s) described in the issued claims.
[0153] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the accompanying detailed description. Instead, the embodiments are selected and described to enable others skilled in the art to recognize and understand the principles and practices. Therefore, various aspects have been described with reference to various specific and 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 this article.
[0154] It is to be understood that although many different embodiments of the catheter system have been illustrated and described herein, one or more features of any one embodiment may be combined with one or more features of one or more other embodiments as long as such combination meets the intent of the present invention.
[0155] Although many exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and the claims introduced below be interpreted to include all such modifications, permutations, additions and sub-combinations as are 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 a treatment site within a blood vessel or adjacent to a blood vessel in a patient's body, the catheter system comprising: catheter; A system console, wherein the system controller includes a console connection hole; an energy source configured to generate energy; one or more energy directors configured to receive energy from the energy source; and an optoelectronic connector coupled to the catheter, the optoelectronic connector comprising (i) an introducer coupling housing retaining at least a portion of each of the one or more energy directors, the introducer coupling housing being configured to selectively mechanically couple to the system console, wherein at least a portion of the introducer coupling housing is configured to fit and selectively retain within the console connection aperture such that the one or more energy directors are adjustably aligned within the introducer coupling housing and relative to energy from the energy source to receive energy from the energy source; and (ii) at least a portion of an electrical connector assembly positioned adjacent to the guide coupling housing and configured to transmit at least one of power and data between the system console and the conduit when the guide coupling housing is retained within the console connection aperture.
2. The catheter system according to claim 1, wherein: The electrical connection assembly includes a first electrical connector positioned within the system console and a second electrical connector positioned adjacent the guide coupling housing, the second electrical connector being configured to mate with the first electrical connector when the guide coupling housing is retained within the console connection aperture.
3. The catheter system of 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 of claim 2, wherein: The electrical connection assembly also includes an electrical cable electrically connected to the second electrical connector and the catheter.
5. The catheter system of claim 1, wherein: The energy source is positioned within the system console.
6. The catheter system of claim 1, wherein: The optoelectronic connector also includes (i) a plurality of ferrules, each of the plurality of ferrules being configured to hold a portion of one of the one or more energy directors, and (ii) a ferrule housing having a plurality of positioning holes, each of the plurality of positioning holes being configured to hold at least a portion of one of the plurality of ferrules spaced apart from one another, each of the plurality of positioning holes being larger than a diameter of the ferrule held therein to allow the ferrule to move relative to the positioning holes.
7. The catheter system of claim 6, wherein: The ferrule housing is adjustably positionable within the guide coupling housing such that the ferrule housing is movable relative to the guide coupling housing.
8. The catheter system of claim 6, wherein: The guide coupling housing includes a console-facing side; and wherein the plurality of ferrules are recessed from the console-facing side of the guide coupling housing.
9. The catheter system of claim 1, wherein: The photoelectric connector further includes a sealing member that seals a connection between the guide coupling housing and the console connection hole.
10. The catheter system of claim 1, wherein: The optoelectronic connector also includes a contaminant inhibitor positionable about at least a portion of the director coupling housing, the contaminant inhibitor configured to inhibit dust and particles from contaminating a face of each of the one or more energy directors.
11. The catheter system of claim 1, wherein: The optoelectronic connector also 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 aperture.
12. The catheter system of claim 1, wherein: The system console also includes an optical sensor and an actuator; the optical sensor is configured to sense the position of the guide coupling housing relative to the console connection hole, and the optical sensor is also configured to activate the actuator, which mechanically pulls the guide coupling housing into an appropriate position within the console connection hole.
13. The catheter system of claim 1 , further comprising a balloon configured to be positioned substantially adjacent to the treatment site, the balloon comprising a balloon wall defining a balloon interior, the balloon being configured to retain a catheter fluid within the balloon interior, each of the one or more energy directors comprising a director distal end configured to be positioned within the balloon interior, each of the one or more energy directors being configured to direct energy from the energy source through the energy director and into the balloon interior, and each of the one or more energy directors directing energy from the energy source into the balloon interior generates plasma in the catheter fluid within the balloon interior.
14. The catheter system of claim 1, wherein: At least one of the one or more energy directors comprises an optical fiber and the energy source comprises a laser.
15. A method for treating a treatment site within a patient's body within or adjacent to a blood vessel, the method comprising the steps of: Providing a system console, the system controller comprising a console connection hole; Generate energy using an energy source; receiving energy from the energy source using one or more energy directors; coupling an optoelectronic connector to the catheter, the optoelectronic connector comprising a guide coupling housing and at least a portion of an electrical connector assembly; retaining at least a portion of each of the one or more energy directors with the director coupling housing of the optoelectronic connector; selectively mechanically coupling the director coupling housing to the system console, wherein at least a portion of the director coupling housing is configured to fit and selectively be retained within the console connection aperture such that the one or more energy directors are adjustably aligned within the director coupling housing and relative to energy from the energy source to receive energy from the energy source; and At least one of power and data is transmitted between the system console and the catheter using the electrical connector assembly when the introducer coupling housing is retained within the console connection aperture.
16. The method according to claim 15, wherein: The transmitting step includes positioning a first electrical connector within the system console and positioning a second electrical connector near the guide coupling housing, the second electrical connector including a connector base and a plurality of electrical connection pads coupled to the connector base, the second electrical connector being configured to dock with the first electrical connector when the guide coupling housing is retained within the console connection hole.
17. The method according to claim 16, wherein: The step of positioning the second electrical connector includes the second electrical connector including a connector base and a plurality of electrical connection pads coupled to the connector base.
18. The method according to claim 15, wherein: The step of connecting the optoelectronic connector includes that the optoelectronic connector also includes a plurality of ferrules and a ferrule shell having a plurality of positioning holes; and the method also includes the following steps: using each of the plurality of ferrules to hold a portion of one of the one or more energy directors, and using each of the plurality of positioning holes 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 holes is larger than the diameter of the ferrule held therein to allow the ferrule to move relative to the positioning holes; and wherein the ferrule shell can be adjustably positioned within the director connecting shell so that the ferrule shell can move relative to the director connecting shell.
19. The method according to claim 15, wherein: The step of providing the system console includes that the system console also includes an optical sensor and an actuator; and the method also includes the following steps: using the optical sensor to sense the position of the guide connecting shell relative to the console connecting hole, and starting the actuator, the actuator mechanically pulling the guide connecting shell into the appropriate position in the console connecting hole based on the sensed position of the guide connecting shell relative to the console connecting hole.
20. A catheter system for treating a treatment site within or adjacent to a blood vessel in a patient's body, the catheter system comprising: catheter; A system console, the system console comprising a console connection hole, an optical sensor and an actuator; an energy source configured to generate energy; one or more energy directors configured to receive energy from the energy source; and An optoelectronic connector coupled to the conduit, the optoelectronic connector comprising: (i) a director coupling housing that retains at least a portion of each of the one or more energy directors, the director coupling housing being configured to be selectively mechanically coupled to the system console, wherein at least a portion of the director coupling housing is configured to fit and selectively retain within the console connection aperture such that the one or more energy directors are adjustably aligned within the director coupling housing and relative to energy from the energy source to receive energy from the energy source, the optical sensor being configured to sense a position of the director coupling housing relative to the console connection aperture and further configured to activate the actuator that mechanically draws the director coupling housing into position within the console connection aperture; (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 retained within the console connection aperture, the electrical connector assembly comprising 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 mate with the first electrical connector when the guide coupling housing is retained within the console connection aperture, the second electrical connector comprising a connector base and a plurality of electrical connection pads coupled to the connector base; (iii) a plurality of collars, each of the plurality of collars being configured to retain a portion of one of the one or more energy directors; and (iv) a ferrule housing having a plurality of positioning holes, each of the plurality of positioning holes being configured to keep at least a portion of one of the plurality of ferrules spaced apart from each other, each of the plurality of positioning holes being larger than a diameter of the ferrule held therein to allow the ferrule to move relative to the positioning holes, the ferrule housing being adjustably positioned within the guide coupling housing so that the ferrule housing is movable relative to the guide coupling housing.