System and method for monitoring pressure within a catheter system
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- BOSTON SCIENTIFIC SCIMED INC
- Filing Date
- 2021-01-27
- Publication Date
- 2026-08-05
Smart Images
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Abstract
Description
Technical Field
[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 62 / 972,268, filed Feb. 10, 2020, entitled "SYSTEM AND METHOD FOR PRESSURE MONITORING WITHIN LITHOPLASTY DEVICE"; U.S. Provisional Patent Application No. 62 / 985,452, filed Mar. 5, 2020, entitled "SYSTEM AND METHOD FOR PRESSURE MONITORING WITHIN LITHOPLASTY DEVICE"; and U.S. Patent Application No. 17 / 154,453, filed Jan. 21, 2021, entitled "SYSTEM AND METHOD FOR PRESSURE MONITORING WITHIN A CATHETER SYSTEM". To the extent permitted, the contents of U.S. Provisional Patent Application No. 62 / 972,268, U.S. Provisional Patent Application No. 62 / 985,452, and U.S. Patent Application No. 17 / 154,453 are hereby incorporated by reference in their entirety.
Background Art
[0002] Vascular lesions within blood vessels in the body can be associated with an increased risk of major adverse events such as myocardial infarction, embolism, deep vein thrombosis, and stroke. Severe vascular lesions can be difficult to treat and achieve patency for physicians in the clinical setting.
[0003] Vascular lesions can be treated using interventions such as, by way of example, drug therapy, balloon angioplasty, atherectomy, stent placement, vascular graft bypass, and the like. Such interventions may not always be ideal or may require subsequent treatment to address the lesion.
Summary of the Invention
[0004] The present invention relates to a catheter system for placement within a blood vessel having a vascular wall. The catheter system can be used to treat a treatment site within or adjacent to the vascular wall. In various embodiments, the catheter system includes an energy source, a balloon, an energy guide, and a pressure sensor. The energy source generates energy. The balloon can be positioned substantially adjacent to the treatment site. The balloon has a balloon wall that defines the interior of the balloon, which receives balloon fluid. The energy guide can be configured to receive energy from the energy source and guide that energy into the interior of the balloon. The pressure sensor is configured to sense the balloon pressure of the balloon fluid inside the balloon.
[0005] In some embodiments, the pressure sensor is in fluid communication with the balloon fluid inside the balloon.
[0006] In certain embodiments, the pressure sensor is located inside the balloon.
[0007] In various embodiments, the catheter system may further include a handle assembly coupled to a balloon, the handle assembly being positioned spaced apart from the balloon, and the handle assembly being available for use by a user to operate the catheter system.
[0008] In certain embodiments, the pressure sensor may be located within the handle assembly.
[0009] In another embodiment, the pressure sensor can be positioned between the handle assembly and the inside of the balloon.
[0010] In some embodiments, the catheter system may further include a tubular member that enables fluid communication between the inside of the balloon and a pressure sensor. Furthermore, the tubular member may extend into the inside of the balloon.
[0011] In certain embodiments, the pressure sensor generates a sensor signal based at least partially on the sensed balloon pressure of the balloon fluid inside the balloon.
[0012] In some embodiments, the catheter system further includes a system controller that receives sensor signals from a pressure sensor. The system controller can be configured to control the operation of the catheter system based at least in part on the sensor signals. For example, in one application, the system controller can be configured to detect balloon rupture based at least in part on the sensor signals.
[0013] In some embodiments, the system controller may be configured to detect, at least partially, that the energy source is unable to generate energy, based on the sensor signal.
[0014] In various embodiments, the system controller can be configured to detect the proper operation of the energy source based at least partially on the sensor signal.
[0015] In certain embodiments, the system controller may be configured to determine therapeutic effectiveness based at least partially on sensor signals.
[0016] In some embodiments, at least a portion of the system controller can be located within the handle assembly.
[0017] In various embodiments, balloon fluid can be provided inside the balloon so that the balloon can expand from a folded configuration to an extended configuration.
[0018] In certain embodiments, an energy source generates energy pulses that are guided into the balloon along an energy guide to induce plasma formation within the balloon fluid inside the balloon. Plasma formation can cause rapid bubble formation and can impart pressure waves to the balloon wall adjacent to the treatment site.
[0019] In some embodiments, the pressure sensor can be one of the following: an optical fiber sensor, a diaphragm sensor, a MEMS sensor, or any other suitable type of pressure sensor.
[0020] In various embodiments, the energy source can include a laser.
[0021] In certain embodiments, the energy source may include a high-voltage energy source that provides high-voltage pulses.
[0022] In various embodiments, the energy guide may include one or more optical guides, each of which may contain an optical fiber.
[0023] In some embodiments, the energy guide may include a pair of electrodes having spaced-out electrodes extending into the balloon. A high-voltage pulse from an energy source can be applied to the electrodes to form an electric arc on them.
[0024] In certain embodiments, the present invention further relates to a method for treating a treatment site within or adjacent to a vascular wall, comprising the steps of: generating energy with an energy source; positioning a balloon substantially adjacent to the treatment site, wherein the balloon has a balloon wall defining the interior of the balloon that receives balloon fluid; receiving energy from the energy source with an energy guide and guiding the energy into the interior of the balloon with the energy guide; and sensing the balloon pressure of the balloon fluid inside the balloon with a pressure sensor.
[0025] In various embodiments, the generating step can include that the energy source is a high-voltage energy source that provides high-voltage pulses.
[0026] In certain embodiments, the receiving step can include that the energy guide includes spaced electrodes that extend inside the balloon.
[0027] In some embodiments, the method can include applying a high-voltage pulse from the energy source to the electrodes to form an electric arc on the electrodes.
[0028] As used herein, "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions "at least one of A, B, and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and / or C" means only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. Each of A, B, and C in the above expressions refers to an element such as X, Y, and Z, or a class of elements such as X1~X n 、Y1~Y m 、and Z1~Z o When referring to a class of elements such as, etc., this phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., X1 and X2), and a combination of elements selected from two or more classes (e.g., Y1 and Z o ).
[0029] Note that the terms “one (a)” or “one (an)” refer to one or more of those entities. Thus, the terms “one (a)” (or “one (an)”), “one or more” and “at least one” are interchangeable in this specification. Note also that the terms “equip,” “include,” and “have” are interchangeable.
[0030] It should be understood that any maximum numerical limitation provided through this disclosure is intended to include, as if expressly provided herein, any lower numerical limitation. Any minimum numerical limitation provided through this disclosure is intended to include, as if expressly provided herein, any higher numerical limitation. All numerical ranges provided through this disclosure are intended to include, as if expressly provided herein, any narrower numerical ranges that fall within such a wider range.
[0031] The above is a simplified overview of the Disclosure to provide an understanding of some aspects of the Disclosure. This overview is not a broad or exhaustive overview of the Disclosure or its various aspects, embodiments, and configurations. It is not intended to identify key or important elements of the Disclosure or to describe the scope of the Disclosure, but rather to present selected concepts of the Disclosure in a simplified form as an introduction to the more detailed descriptions presented below. As will be understood, other aspects, embodiments, and configurations of the Disclosure are possible, either alone or in combination, by utilizing one or more of the features described above or in detail below.
[0032] This summary is an overview of some of the teachings of this 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 be apparent to those skilled in the art by reading and understanding the following detailed description and by looking at the drawings which form part thereof, and each of them is not to be construed as restrictive. The scope of this specification is defined by the appended claims and their legal equivalents.
[0033] The novel features of the present invention, as well as the invention itself, will be best understood from the accompanying drawings in conjunction with the accompanying description, both in terms of its structure and operation. In the accompanying drawings, similar reference numerals indicate similar parts. [Brief explanation of the drawing]
[0034] [Figure 1] This is a schematic cross-sectional view of one embodiment of a catheter system according to various embodiments of this specification, the catheter system including a pressure sensor assembly. [Figure 2] This is a schematic cross-sectional view of a portion of an embodiment of a catheter system, including one embodiment of a pressure sensor assembly. [Figure 3] This is a schematic cross-sectional view of a portion of an embodiment of a catheter system, including another embodiment of a pressure sensor assembly. [Modes for carrying out the invention]
[0035] While various modifications and alternative forms are possible for the embodiments of the present invention, their specifics are shown by examples and figures and described in detail herein. However, it should be understood that the scope of this specification is not limited to the specific embodiments described. On the contrary, the intent is to cover modifications, equivalents, and alternatives that fall within the spirit and scope of this specification.
[0036] Treatment of vascular lesions can reduce major adverse events or mortality in affected patients. As referred to herein, major adverse events are any adverse events that may occur anywhere in the body as a result of the presence of vascular lesions. Major adverse events may include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in the muscular system, or major adverse events in any of the internal organs.
[0037] The catheter systems and related methods disclosed herein are configured to monitor the performance, reliability, and safety of the catheter. In various embodiments, the catheter systems of the present invention utilize an energy source that provides energy guided by an energy guide to generate a localized plasma within the balloon fluid inside the inflatable balloon of the catheter, such as a light source, for example, a laser source in certain embodiments, or another suitable energy source. This localized plasma then induces high-energy bubbles inside the balloon, generating pressure waves and / or pressure waves that apply pressure to a treatment site, such as a calcified vascular lesion or a fibrous vascular lesion, within or adjacent to the vessel wall, inducing fragmentation within it. When used herein, the treatment site may, in non-exclusive examples, typically include vascular lesions such as calcified vascular lesions or fibrous vascular lesions found inside and / or near heart valves, such as the mitral valve or aortic valve.
[0038] Importantly, as described in detail herein, the catheter system of the present invention includes a pressure sensor configured to monitor the pressure of the balloon fluid held inside the balloon of the balloon. Specific examples of problems addressed by the present invention, but not limited to, include (1) detection of balloon rupture or burst, (2) detection of successful firing of a plasma generator, i.e., an energy source, (3) detection of plasma generator failure, and (4) monitoring of the progress of the procedure and the effectiveness of the treatment.
[0039] In particular, in various embodiments, the catheter system may include a catheter configured to advance into a treatment site within or adjacent to a blood vessel or heart valve. The catheter includes a catheter shaft and a balloon coupled to and / or fixed to the catheter shaft. The balloon herein may include a balloon wall defining the interior of the balloon and may be configured to receive balloon fluid into the balloon to expand from a folded configuration suitable for advancing the catheter through the patient's vascular system to an expanded configuration suitable for fixing the catheter in place relative to the treatment site. The catheter system also includes one or more energy guides, for example, a light guide in certain embodiments, positioned within the balloon along the catheter shaft. Each energy guide may be configured to generate a pressure wave within the balloon to disrupt a vascular lesion. The catheter system utilizes energy from an energy source, for example, light energy from a light source in certain embodiments, to generate plasma within the balloon fluid at or near the distal end of the guide of an energy guide positioned within the balloon at the treatment site. Plasma formation may initiate a pressure wave and initiate the rapid formation of one or more bubbles, which may be dissipated by cavitation events that rapidly expand to their maximum size and then emit a pressure wave upon collapse. The rapid expansion of plasma-induced bubbles can generate one or more pressure waves within the balloon fluid held inside the balloon, thereby applying pressure waves to the treatment site. In some embodiments, the energy source can be configured to provide sub-millisecond pulses of energy from the energy source to initiate plasma formation within the balloon fluid inside the balloon in order to induce rapid bubble formation and apply pressure waves to the balloon wall at the treatment site. Thus, the pressure waves can transfer mechanical energy to the treatment site via the incompressible balloon fluid, thereby applying fragmentation force to vascular lesions.
[0040] Furthermore, the catheter system further includes a pressure sensor that can be placed at any suitable location within the catheter system. As described in detail herein, the pressure sensor is configured to sense and / or monitor the fluid pressure of the balloon fluid inside the balloon (sometimes referred to herein as “balloon pressure”) during the operation of the catheter system. The pressure sensor generates a sensor output related to the sensed fluid pressure and can provide such a sensor output to a system controller configured to control various operations of the catheter system. This sensing and / or monitoring of fluid pressure by the pressure sensor provides the user or operator with useful information regarding the performance, reliability, and safety of the catheter system.
[0041] As used herein, the terms “intravascular lesion,” “vascular lesion,” and / or “treatment site” are interchangeable unless otherwise specified. Therefore, intravascular lesions and / or vascular lesions may be referred to simply as “lesions” in this specification.
[0042] Those skilled in the art will recognize that the following detailed description of the invention is illustrative and not intended to limit it in any way. Other embodiments of the invention will be readily proposed to such skilled in the art who are interested in this disclosure. Hereinafter, embodiments of the invention shown in the accompanying drawings will be referenced in detail.
[0043] For clarity, not all common features of the implementations described herein are shown or explained. Naturally, the development of such actual implementations requires numerous implementation-specific decisions to achieve the developer's specific goals, such as compliance with application- and business-related constraints, and these specific goals will differ from embodiment to embodiment and from developer to developer. Furthermore, while such development efforts can be complex and time-consuming, they are nevertheless considered routine engineering work for those skilled in the art who are interested in this disclosure.
[0044] It will be understood that the catheter systems disclosed herein can include many different forms. Referring here to Figure 1, schematic cross-sectional views of catheter systems 100 according to various embodiments herein are shown. As described herein, catheter systems 100 are suitable for applying pressure to induce fragmentation within the vessel wall of a blood vessel or within one or more treatment sites 106 adjacent to the vessel wall. In the embodiment shown in Figure 1, catheter systems 100 may include a catheter 102, an energy guide bundle 122 (sometimes referred to herein as the “optical guide bundle”) including one or more energy guides 122A (sometimes referred to herein as “optical guides”), a system console 123 including one or more of a source manifold 136, a fluid pump 138, a light source 124 (sometimes referred to herein as the “energy source”), a power supply 125, a system controller 126, and a system console 123 including one or more of a graphical user interface 127 (“GUI”), a handle assembly 128, and a pressure sensor assembly 142.
[0045] The catheter 102 is configured to move into or adjacent to a treatment site 106 within a blood vessel 108. The treatment site 106 may include one or more vascular lesions, such as calcified vascular lesions. Additionally, or alternatively, the treatment site 106 may include vascular lesions such as fibrovascular lesions.
[0046] The catheter 102 may include an inflatable balloon 104 (sometimes simply referred to herein as the “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 proximal end 104P and a 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 shaft 110 may also include a guidewire lumen 118 configured to move along the guidewire 112. The catheter shaft 110 may further include an inflation lumen (not shown). In some embodiments, the catheter 102 may have a distal end opening 120 that can accommodate and track the guidewire 112 as the catheter 102 moves and is positioned near the treatment site 106.
[0047] In various embodiments, the catheter shaft 110 of the catheter 102 can be coupled to one or more optical guides 122A of an optical guide bundle 122 that optically communicates with a light source 124. The optical guides 122A can be arranged within the balloon 104 along the catheter shaft 110. In some embodiments, each optical guide 122A can be an optical fiber, and the light source 124 can be a laser. The light source 124 can optically communicate with the optical guides 122A in the proximal portion 114 of the catheter system 100.
[0048] In some embodiments, the catheter shaft 110 can be coupled to multiple optical guides 122A, such as a first optical guide, a second optical guide, a third optical guide, etc., which can be positioned at any suitable location around the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two optical guides 122A can be spaced about 180 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Three optical guides 122A can be spaced about 120 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Or, four optical guides 122A can be spaced about 90 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Further alternatively, the multiple optical guides 122A do not need to be uniformly spaced apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, it will be further understood that the optical guides 122A described herein can be uniformly or non-uniformly arranged around the guidewire lumen 118 and / or catheter shaft 110 to achieve the desired effect at the desired location.
[0049] The balloon 104 may include a balloon wall 130 defining the balloon interior 146 and can be inflated by the balloon fluid 132 to expand from a folded configuration suitable for advancing the catheter 102 through the patient's vascular system to an expanded configuration suitable for securing the catheter 102 in place relative to the treatment site 106. In other words, when the balloon 104 is in the expanded configuration, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. In some embodiments, the light source 124 of the catheter system 100 may be configured to provide sub-millisecond pulses of light from the light source 124 along the optical guide 122A to the location of the balloon interior 146 of the balloon 104, thereby inducing plasma formation within the balloon fluid 132 of the balloon interior 146 of the balloon 104. Plasma formation causes rapid bubble formation, imparting a pressure wave to the treatment site 106. An exemplary plasma-induced bubble is shown as bubble 134 in Figure 1.
[0050] While the catheter system 100 described herein is generally described as comprising a light source 124 and one or more optical guides 122A, it is understood that the catheter system 100 may alternatively and equally include and / or utilize any suitable energy source and energy guide for the purpose of generating a desired plasma within the balloon fluid 132 inside the balloon 146. For example, in one non-exclusive alternative embodiment, the energy source 124 may be configured to provide high-voltage pulses, and each energy guide 122A may include a pair of electrodes, each spaced apart, extending into the balloon interior 146. In such an embodiment, each high-voltage pulse is applied to the electrodes, forming an electric arc on the electrodes, and then a pressure wave within the balloon fluid 132, which is utilized to provide a fracturing force to the treatment site 106. Further alternatively, the energy source 124 and / or energy guides 122A may have another suitable design. Thus, while the specific embodiments shown and described herein focus on “light source” and “optical guide,” etc., it is understood that this is not intended to limit the disclosure herein to optical systems. Rather, it should be noted that other types of energy sources and energy guides can be used in the systems and methods provided herein, and that “light sources” and “light guides,” etc., are provided as examples, not as limitations, to facilitate understanding of this disclosure.
[0051] A balloon 104 suitable for use in the catheter system 100 described in detail herein includes a balloon that can pass through the patient's vascular system when in a folded configuration. In some embodiments, the balloon 104 herein is made from silicone. In other embodiments, the balloon 104 herein is made from polymers such as polydimethylsiloxane (PDMS), polyurethane, PEBAX® material available from Arkema, King of Prussia, Pennsylvania, USA, nylon, etc. In some embodiments, the balloon 104 may have a diameter ranging from 1 millimeter (mm) to 25 mm. In some embodiments, the balloon 104 may have a diameter ranging from at least 1.5 millimeters (mm) to 12 mm. In some embodiments, the balloon 104 may have a diameter ranging from at least 1 millimeter to 5 mm.
[0052] In some embodiments, the balloon 104 herein may include having a length in the range of at least 5 mm to 300 mm. More specifically, in some embodiments, the balloon 104 herein may include having a length in the range of at least 8 mm to 200 mm. It is understood that longer balloons 104 can be placed adjacent to larger treatment sites 106 and thus may be used to apply pressure to a larger treatment site 106 or multiple treatment sites 106 and induce rupture therein.
[0053] The balloon 104 described herein can be inflated to an inflation pressure (also called “fluid pressure” and / or “balloon pressure”) from approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 described herein can be inflated to an inflation pressure of at least 20 atm to 70 atm. In other embodiments, the balloon 104 described herein can be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet another embodiment, the balloon 104 described herein can be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet another embodiment, the balloon 104 described herein can be inflated to an inflation pressure of at least 2 atm to 10 atm.
[0054] The balloon 104 herein may have a variety of shapes, including, but is not limited to, conical, square, rectangular, spherical, conical / square, conical / spherical, elongated spherical, elliptical, tapered, bony, stepped diameter, offset, or conical offset. In some embodiments, the balloon 104 herein may include a drug-eluting coating or a drug-eluting stent structure. The drug-eluting coating or drug-eluting stent may contain one or more therapeutic agents, such as anti-inflammatory agents, antineoplastic agents, or anti-angiogenic agents.
[0055] The balloon fluid 132 can be a liquid or a gas. Exemplary balloon fluids 132 suitable for use herein, but not limited to, may include one or more of the following: water, saline, contrast agents, fluorocarbons, perfluorocarbons, carbon dioxide, and other gases. In some embodiments, the balloon fluid 132 described can be used as a base inflation fluid. In some embodiments, the balloon fluid 132 contains a mixture of saline and contrast agent in a 50:50 volume ratio. In other embodiments, the balloon fluid 132 contains a mixture of saline and contrast agent in a 25:75 volume ratio. In yet another embodiment, the balloon fluid 132 contains a mixture of saline and contrast agent in a 75:25 volume ratio. Furthermore, the balloon fluid 132 suitable for use herein can be adjusted based on composition, viscosity, etc., to manipulate the velocity of the pressure wave within it. In certain embodiments, the balloon fluid 132 suitable for use herein is biocompatible. The volume of the balloon fluid 132 can be adjusted depending on the selected light source 124 and the type of balloon fluid 132 used.
[0056] In some embodiments, the contrast agents used herein may include, but are not limited to, iodine-based contrast agents such as ionic or nonionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoates, metrizoates, iotalamates, and ioxagrates. Some non-limiting examples of nonionic iodine-based contrast agents include iopamidol, iohexol, ioxiran, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium(III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as perfluorocarbon dodecafluoropentane (DDFP, C5F12).
[0057] The balloon fluid 132 described herein may include an absorbent capable of selectively absorbing 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. A suitable absorbent may include one having a maximum absorption value along the spectrum at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 may include an absorbent capable of selectively absorbing 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 absorbent may have a maximum absorption value that coincides with the emission maximum of a laser used in a catheter system. As non-limiting examples, the various lasers described herein may include neodymium:yttrium-aluminum-garnet (Nd:YAG - emission maximum = 1064 nm) lasers, holmium:YAG (Ho:YAG - emission maximum = 2.1 μm) lasers, or erbium:YAG (Er:YAG - emission maximum = 2.94 μm) lasers. In some embodiments, the absorbers used herein may be water-soluble. In other embodiments, the absorbers used herein may not be water-soluble. In some embodiments, the absorbers used herein in the balloon fluid 132 may be adjusted to match the peak emission of the light source 124. Various light sources 124 having emission wavelengths from at least 10 nanometers to 1 millimeter are discussed elsewhere in this specification.
[0058] It is understood that the catheter system 100 and / or optical guide bundle 122 disclosed herein may include any number of optical guides 122A that optically communicate with a light source 124 at the proximal portion 114 and with the balloon fluid 132 inside the balloon 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or optical guide bundle 122 may include one to five optical guides 122A. In other embodiments, the catheter system 100 and / or optical guide bundle 122 may include five to fifteen optical guides 122A. In yet another embodiment, the catheter system 100 and / or optical guide bundle 122 may include ten to thirty optical guides 122A. Or, in yet another embodiment, the catheter system 100 and / or optical guide bundle 122 may include more than 30 optical guides 122A.
[0059] It is further understood that the optical guide 122A can be positioned at any suitable location on the circumference of the guidewire lumen 118 and / or the catheter shaft 110, and that each distal end of the optical guide 122A can be positioned at any suitable longitudinal location relative to the length of the balloon 104 and / or the length of the guidewire lumen 118.
[0060] The optical guide 122A described herein can take many configurations around and / or relative to the catheter shaft 110 of the catheter 102 described herein. In some embodiments, the optical guide 122A can pass parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the optical guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the optical guide 122A can be arranged along the length of the outer diameter of the catheter shaft 110. In yet another embodiment, the optical guide 122A described herein can be arranged in one or more optical guide lumens within the catheter shaft 110.
[0061] The supply manifold 136 may be located in or near the proximal portion 114 of the catheter system 100. The supply manifold 136 may include one or more proximal end openings that can receive multiple optical guides 122A of the optical guide bundle 122, guide wires 112, and / or an expansion conduit 140 coupled in fluid communication with the fluid pump 138. The catheter system 100 may also include the fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132, if necessary.
[0062] As noted above, in the embodiment shown in Figure 1, the system console 123 may include one or more of the light source 124, power supply 125, system controller 126, and GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically shown in Figure 1. For example, in certain non-exclusive alternative embodiments, the system console 123 can be designed without the GUI 127. Further alternatively, one or more of the light source 124, power supply 125, system controller 126, and GUI 127 can be provided within the catheter system 100 without specifically requiring the system console 123.
[0063] The system console 123 and its components are operably coupled to the catheter 102, the optical guide bundle 122, and the rest of the catheter system 100. For example, in some embodiments, as shown in Figure 1, the system console 123 may include a console connection opening 148 (sometimes commonly referred to as a “socket”) into which the optical guide bundle 122 is mechanically coupled. In such embodiments, the optical guide bundle 122 may include a guide coupling housing 150 (sometimes commonly referred to as a “ferrule”) that accommodates each portion of the optical guide 122A, for example, the proximal end of the guide. The guide coupling housing 150 is configured to fit into and selectively hold within the console connection opening 148 to provide the desired mechanical coupling between the optical guide bundle 122 and the system console 123.
[0064] The optical guide bundle 122 may also include a guide bundler 152 (or "shell") that brings each of the individual optical guides 122A closer together, thereby allowing the optical guides 122A and / or the optical guide bundle 122 to be in a more compact form, as they extend into the blood vessel 108 together with the catheter 102 during use of the catheter system 100.
[0065] As provided herein, the light source 124 can be selectively and / or alternatively optically connected and coupled to each of the optical guides 122A in the optical guide bundle 122. In particular, the light source 124 is configured to generate light energy in the form of a light source beam 124A, for example, a pulsed light source beam, which can be selectively and / or alternatively directed and received to each of the optical guides 122A in the optical guide bundle 122 as individual guide beams 124B. Alternatively, the catheter system 100 may include two or more light sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 may include a separate light source 124 for each of the optical guides 122A in the optical guide bundle 122.
[0066] The light source 124 can have any suitable design. In certain embodiments, as noted above, the light source 124 can be configured to provide sub-millisecond pulses of light from the light source 124, which are directed along the optical guide 122A to a location within the balloon 104, thereby inducing plasma formation within the balloon fluid 132 within the balloon 104. Plasma formation causes rapid bubble formation, which imparts a pressure wave to the treatment site 106. In such embodiments, the sub-millisecond pulses of light from the light source 124 can be delivered to the treatment site 106 at a frequency between approximately 1 Hz and 5000 Hz. In some embodiments, the sub-millisecond pulses of light from the light source 124 can be delivered to the treatment site 106 at a frequency between approximately 30 Hz and 1000 Hz. In other embodiments, the sub-millisecond pulses of light from the light source 124 can be delivered to the treatment site 106 at a frequency between approximately 10 Hz and 100 Hz. In yet another embodiment, sub-millisecond pulsed light from the light source 124 can be delivered to the treatment site 106 at a frequency of approximately 1 Hz to 30 Hz. Alternatively, sub-millisecond pulsed light can be delivered to the treatment site 106 at a frequency that may be greater than 5000 Hz.
[0067] While the light source 124 is typically used to provide pulses of light energy, it is understood that the light source 124 can also be described as providing a single light source beam 124A, i.e., a single pulsed light source beam.
[0068] The light source 124 suitable for use in this specification may include various types of light sources, including lasers and lamps. Alternatively, as noted above, the light source 124 referred to herein may include any suitable type of energy source, such as a high-voltage energy source that provides high-voltage pulses of energy.
[0069] A suitable laser may include a short-pulse laser with a sub-millisecond timescale. In some embodiments, the light source 124 may include a laser with a nanosecond (ns) timescale. Lasers may also include short-pulse lasers with picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is understood that there are many combinations of laser wavelength, pulse width, and energy level that can be used to achieve plasma within the balloon fluid 132 of the catheter 102 described herein. In various embodiments, the pulse width may include a range of at least 10 ns to 200 ns. In some embodiments, the pulse width may include a range of at least 20 ns to 100 ns. In other embodiments, the pulse width may include a range of at least 1 ns to 500 ns.
[0070] Exemplary nanosecond lasers may include those in the UV to IR spectrum spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, a light source 124 suitable for use in the catheter system 100 herein may be capable of generating light with wavelengths from at least 750 nm to 2000 nm. In other embodiments, the light source 124 may be capable of generating light with wavelengths from at least 700 nm to 3000 nm. In yet another embodiment, the light source 124 may be capable of generating light with wavelengths from at least 100 nm to 10 micrometers (μm). Nanosecond lasers may have repetition rates up to 200 kHz. In some embodiments, the laser may include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser. In other embodiments, the laser may include neodymium:yttrium-aluminum-garnet (Nd:YAG), holmium:yttrium-aluminum-garnet (Ho:YAG), erbium:yttrium-aluminum-garnet (Er:YAG), excimer lasers, helium-neon lasers, carbon dioxide lasers, and doped pulsed fiber lasers.
[0071] The catheter system 100 disclosed herein can generate pressure waves having a maximum pressure in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 depends on the light source 124, the absorbing material, the bubble expansion, the propagation medium, the balloon material, and other factors. In some embodiments, the catheter system 100 herein can generate pressure waves having a maximum pressure in the range of at least 2 MPa to 50 MPa. In some embodiments, the catheter system 100 herein can generate pressure waves having a maximum pressure in the range of at least 2 MPa to 30 MPa. In some embodiments, the catheter system 100 herein can generate pressure waves having a maximum pressure in the range of at least 15 MPa to 25 MPa.
[0072] The pressure waves described herein can be applied to the treatment site 106 from a distance of at least 0.1 mm to 25 mm extending radially from the optical guide 122A when the catheter 102 is placed in the treatment site 106. In some embodiments, the pressure waves can be applied to the treatment site 106 from a distance of at least 10 mm to 20 mm extending radially from the optical guide 122A when the catheter 102 is placed in the treatment site 106. In other embodiments, the pressure waves can be applied to the treatment site 106 from a distance of at least 1 mm to 10 mm extending radially from the optical guide 122A when the catheter 102 is placed in the treatment site 106. In yet another embodiment, the pressure waves can be applied to the treatment site 106 from a distance of at least 1.5 mm to 4 mm extending radially from the optical guide 122A when the catheter 102 is placed in the treatment site 106. In some embodiments, a pressure wave may be applied to the treatment site 106 from a range of at least 2 MPa to 30 MPa at a distance of 0.1 mm to 10 mm. In some embodiments, a pressure wave may be applied to the treatment site 106 from a range of at least 2 MPa to 25 MPa at a distance of 0.1 mm to 10 mm.
[0073] The power supply 125 is electrically coupled to each of the light source 124, system controller 126, GUI 127, handle assembly 128, and pressure sensor assembly 142, and is configured to supply the necessary power. The power supply 125 can have any suitable design for such purposes.
[0074] The system controller 126 is electrically coupled to the power supply 125 and receives power from the power supply. Furthermore, the system controller 126 is coupled to each of the light source 124, GUI 127, and pressure sensor assembly 142 and configured to control their operation. The system controller 126 may include one or more processors or circuits for the purpose of controlling the operation of at least the light source 124, GUI 127, and pressure sensor assembly 142. For example, the system controller 126 can, if desired, control the energy source 124, e.g., the light source, to generate pulses of energy, e.g., light energy, at any desired firing rate. Furthermore, the system controller 126 can control the pressure sensor assembly 142 to effectively sense and / or monitor the fluid pressure (or balloon pressure) of the balloon fluid 132 inside the balloon 146 of the balloon, i.e., to more effectively monitor the performance, reliability, and safety of the catheter 102 and catheter system 100. Furthermore, in certain embodiments, the system controller 126 is configured to receive, process, and integrate sensor outputs from the pressure sensor assembly 142 in order to determine and / or adjust the proper functioning of the catheter system 100. In other words, based at least in part on the sensor outputs from the pressure sensor assembly 142, the system controller 126 may determine that a particular modification to the functioning of the catheter system 100 is necessary. In addition, the system controller 126 may also be configured to detect, determine, or otherwise recognize various situations. For example, the system controller 126 may also be configured to detect, determine, or otherwise recognize evidence of balloon rupture or light source malfunction or failure, and / or when the catheter system 100 is functioning properly and effectively.The system controller 126 can then provide the user with an appropriate signal via the GUI 137 in such specific situations, for example, when the pressure sensor assembly 142 provides evidence of balloon rupture or light source malfunction or failure, and / or when the catheter system 100 is operating properly and effectively, or in any other relatively important situation or state of the catheter system 100. Furthermore, in some embodiments, the system controller 126 can be configured to automatically stop the operation of the catheter system 100, in which case the sensor output indicates that such action is appropriate.
[0075] The system controller 126 may be further configured to control the operation of other components of the catheter system 100, such as the positioning of the catheter 102 adjacent to the treatment site 106, or the inflation of the balloon 104 by the balloon fluid 132. Furthermore, or alternatively, the catheter system 100 may include one or more additional controllers that can be arranged in any suitable manner for the purpose of controlling various operations of the catheter system 100. For example, in certain embodiments, additional controllers and / or parts of the system controller 126 may be located and / or incorporated within the handle assembly 128.
[0076] The GUI 127 is accessible to the user or operator of the catheter system 100. Furthermore, the GUI 127 is electrically connected to the system controller 126. In such a design, the GUI 127 is available to the user or operator to ensure that the catheter system 100 is used as desired to apply pressure to the treatment site 106 and induce internal fragmentation. Additionally, the GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. In addition, or alternatively, the GUI 127 can provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. Furthermore, in various embodiments, the GUI 127 may include one or more colors, different sizes, changing brightness, etc., which can act as a warning to the user or operator. Additionally, or alternatively, the GUI 127 can provide the user or operator with audio data or information. It should be understood that the details of GUI127 may vary depending on the design requirements of the catheter system 100, or the specific needs, specifications, and / or requests of the user or operator.
[0077] As shown in Figure 1, the handle assembly 128 can be positioned near or in the proximal portion 114 of the catheter system 100 and / or near the supply manifold 136. Furthermore, in this embodiment, the handle assembly 128 is coupled to the balloon 104 and positioned at a distance from the balloon 104. Alternatively, the handle assembly 128 can be positioned at another suitable location.
[0078] The handle assembly 128 is handled and used by the user or operator to manipulate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be modified to conform to the design requirements of the catheter system 100. In the embodiment shown in Figure 1, the handle assembly 128 is separated from one or more of the system controller 126, light source 124, fluid pump 138, GUI 127, and pressure sensor assembly 142, but is in electrical and / or fluid communication with them. 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. It will be understood that the handle assembly 128 may include fewer or additional components than those specifically shown and described herein.
[0079] In summary, and as will be provided in more detail herein, the pressure sensor assembly 142 can sense and / or monitor the balloon pressure inside the balloon 146 of the balloon 104. More specifically, the pressure sensor assembly 142, in conjunction with electronic or optical equipment that can be included in the handle assembly 128 and / or the system console 123, can provide real-time continuous monitoring of the balloon pressure inside the balloon 146. Furthermore, the pressure sensor assembly 142 can generate a sensor signal or sensor output based at least partially on the balloon pressure, which is provided to other structures within the catheter system 100, such as the system controller 126. The system controller 126 processes and arranges the sensor signal from the pressure sensor assembly 142 to observe changes in different time regimes. The system controller 126 can then control various functions of the catheter system 100 described herein, based at least partially on the sensor signal or sensor output, i.e., at least partially on the balloon pressure inside the balloon 146 of the balloon 104.
[0080] As described in detail herein, the pressure sensor assembly 142 can be positioned at any suitable location within the catheter system 100 so as to communicate with the balloon fluid 132 inside the balloon 146. For example, in certain embodiments, at least a portion of the pressure sensor assembly 142 can be substantially positioned inside the balloon 146 of the balloon 104. Additionally, or alternatively, at least a portion of the pressure sensor assembly 142 can be substantially positioned within the handle assembly 128. Furthermore, or alternatively, at least a portion of the pressure sensor assembly 125 can be substantially positioned between the handle assembly 128 and inside the balloon 146 of the balloon 104. Furthermore, or alternatively, at least a portion of the pressure sensor assembly 142 can be positioned at another suitable location within the catheter system 100.
[0081] As noted above, the pressure sensor assembly 142 of the present invention addresses several important issues relating to the performance, reliability, and safety of a catheter, particularly a catheter that uses an energy source, such as a light source 124, to generate localized plasma that induces high-energy bubbles inside the balloon 104. For example, as noted above, the issues addressed by the present invention include, but are not limited to, (1) detection of balloon rupture or burst, (2) detection of successful firing of the plasma generator, i.e., the light source or other suitable energy source, (3) detection of failure of the plasma generator, i.e., the light source or other suitable energy source, and (4) monitoring of the progress of the procedure and the effectiveness of the treatment.
[0082] In particular, during use of the catheter system 100, the pressure sensor assembly 142 is configured to continuously monitor the average static internal balloon pressure of the balloon fluid 132 inside the balloon 146.
[0083] In the first sensed condition, if the monitored balloon pressure changes rapidly from a high level to zero or near zero, it may indicate that the balloon 104 has ruptured. In such a situation, the catheter system 100, i.e., the system controller 126, filters the sensor signal from the pressure sensor assembly 142 to examine the duty cycle or slowly changing signal. Such a sensor signal indicating a rapid decrease in balloon pressure can be used to automatically lock out the energy source 124 and / or to provide the operator with an indicator to stop the procedure and remove the catheter 102. During use of the catheter system 100, it is understood that if the balloon 104 ruptures, the procedure must be stopped as quickly as possible. The devices and methods described herein can rapidly and successfully detect the rupture of the balloon 104 and provide an indicator or signal that can be used to stop or rapidly decelerate the energy source 124. This feature can provide a safety interlock against a potentially dangerous condition in which balloon fluid 132 may leak into the patient.
[0084] In another sensed condition, the pressure sensor assembly 142 may sense and / or detect relatively small dynamic changes relative to a larger average static balloon pressure. These short-duration acoustic pulses are understood to be generated when the plasma-driven bubbles expand and collapse. The catheter system 100 and / or system controller 126 filter the sensor signals from the pressure sensor assembly to remove duty cycle or slowly changing signals and isolate high-frequency signals or transient events. Such sensed conditions correlate with the firing of the plasma-generating energy source 124. If an acoustic transient balloon pressure is detected within a predetermined time interval from the firing of the energy source 124, this provides an indication that the catheter system 100 is functioning correctly and thus enables the next event in the sequence.
[0085] In yet another sensed condition, if a transient balloon pressure change sensed by the pressure sensor assembly 142 is not detected within a specific time interval after the firing of the energy source 124, this provides an indication of a malfunction in the catheter system 100, for example, that the energy source 124 is unable to fire properly. Such a sensor signal can be used to automatically lock out the energy source 124 and / or to provide the operator with an indicator to stop the procedure and remove the catheter 102.
[0086] In another perceived condition, it is understood that the cross-section of the vessel under treatment should change as the procedure progresses. In particular, the vessel wall relaxes and expands as the calcification is broken down. Such disintegration of the lesion allows the balloon 104 to expand slightly. Thus, the internal balloon pressure 146 inside the balloon 104 should decrease gradually and not drop rapidly to zero. The catheter system 100 and / or system controller 126 filters the sensor signal from the pressure sensor assembly 142 to monitor the duty cycle and slowly changing signal as well as burst detection. Such small incremental changes in balloon pressure, rather than a rapid drop to zero, provide an indication of acceptable progress of the procedure and thus provide an indicator of the effectiveness of the procedure.
[0087] It is understood that the aforementioned sensed states are not intended to include, and in no way to limit, all such situations detectable by the system controller 126. These sensed states are provided for ease of understanding and represent only a few states for which one may benefit from the devices and / or methods provided herein.
[0088] Figure 2 is a schematic cross-sectional view of a portion of one embodiment of the catheter system 200, including one embodiment of the pressure sensor assembly 242. The design of the catheter system 200 can be modified as described in detail herein. In various embodiments, as shown in Figure 2, the catheter system 200 may include a catheter shaft 210, a catheter 202 including a balloon 204 having a balloon wall 230 defining the balloon interior 246, a proximal balloon end 204P, and a distal balloon end 204D, balloon fluid 232 substantially held in the balloon interior 246, and a guidewire lumen 218 extending into the balloon interior 246; an energy guide 222 (sometimes referred to herein as an “optical guide”); a handle assembly 228; and a pressure sensor assembly 242. Alternatively, in other embodiments, the catheter system 200 may include more or fewer components than those specifically shown and described herein. For example, certain components shown in Figure 1, such as the guidewire 112, energy source 124 (sometimes referred to herein as the “light source”), system controller 126, GUI 127, supply source manifold 136, and fluid pump 138, are likely to be included in any embodiment of the catheter system 200, although they are not specifically shown in Figure 2 for clarity.
[0089] The catheter 202, including the catheter shaft 210, the balloon 204, and the guidewire lumen 218, is typically similar in design and operation to those described in detail above herein. Therefore, such components will not be described again in detail in relation to the embodiment shown in Figure 2.
[0090] As described above, the balloon 204 is selectively movable between a folded configuration suitable for advancing the catheter 202 through the patient's vascular system and an extended configuration suitable for securing the catheter 202 in place relative to the treatment site 106 (shown in Figure 1). In some embodiments, the proximal end 204P of the balloon can be coupled to the catheter shaft 210, and the distal end 204D of the balloon can be coupled to the guidewire lumen 218. Furthermore, the balloon 204 can be inflated with balloon fluid 232 from a fluid pump 138 (shown in Figure 1), which is guided into the balloon interior 246 of the balloon 204, for example, via an inflation conduit 140 (shown in Figure 1).
[0091] The energy guide 222 may have any suitable design for the purpose of generating plasma and / or pressure waves within the balloon fluid 232 inside the balloon interior 246. Therefore, the specific description of the optical guide 222 herein is not intended to limit it in any way.
[0092] In certain embodiments, the optical guide 222 herein may include an optical fiber or a flexible optical pipe. The optical guide 222 herein may be thin and flexible and may allow the transmission of optical signals with little to no loss of intensity. The optical guide 222 herein may include a core surrounded by cladding. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the optical guide 222 may be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The optical guide 222 may also include a protective coating, such as a polymer. It is understood that the refractive index of the core is greater than that of the cladding.
[0093] Each optical guide 222 can guide light along its length to a distal end 222D of the guide, which has at least one optical window (not shown) located inside the balloon 246. The optical guides 222 can generate optical paths as part of an optical network including a light source 124 (shown in Figure 1). Optical paths in an optical network allow light to travel from one part of the network to another. Both optical fibers and flexible optical pipes can provide optical paths in the optical network described herein.
[0094] The optical guide 222 described herein can take many configurations around and / or relative to the catheter shaft 210 of the catheter 202 described herein. In some embodiments, the optical guide 222 can pass parallel to the longitudinal axis 144 (shown in Figure 1) of the catheter shaft 210 of the catheter 202. In some embodiments, the optical guide 222 can be physically coupled to the catheter shaft 210. In other embodiments, the optical guide 222 can be positioned along the length of the outer diameter of the catheter shaft 210. In yet another embodiment, the optical guide 222 described herein can be disposed within one or more optical guide lumens within the catheter shaft 210.
[0095] The optical guide 222 described herein may include one or more photoacoustic transducers 254, each photoacoustic transducer 254 capable of optically communicating with the optical guide 222 in which it is disposed. In some embodiments, the photoacoustic transducer 254 can optically communicate with the guide distal end 222D of the optical guide 222. Furthermore, in such embodiments, the photoacoustic transducer 254 may have a shape corresponding to and / or conforming to the guide distal end 222D of the optical guide 222.
[0096] The photoacoustic transducer 254 is configured to convert light energy into acoustic waves at or near the guide distal end 222D of the optical guide 222. It is understood that the direction of the acoustic waves can be adjusted by changing the angle of the guide distal end 222D of the optical guide 222.
[0097] It is further understood that the photoacoustic transducer 254 disposed at the guide distal end 222D of the optical guide 222 according to this specification may have the same shape as the guide distal end 222D of the optical guide 222. For example, in certain non-exclusive embodiments, the photoacoustic transducer 254 and / or the guide distal end 222D may have a conical, convex, concave, bulbous, square, stepped, semicircular, oval shape, and the like. It is also understood that the optical guide 222 may further include additional photoacoustic transducers 254 disposed along one or more sides of the length of the optical guide 222.
[0098] The optical guides 222 described herein may further include one or more diverting features or "divertors" (not shown in Figure 2) within the optical guide 222, which are configured to direct light exiting the optical guide 222 toward, for example, the distal end 222D of the optical guide 222 or a nearby side, and toward the balloon wall 230. The diverting features may include any feature of the system herein that redirects light from the optical guide 222 toward a side of the optical guide 222 away from its axial path. Furthermore, each optical guide 222 may include one or more optical windows disposed along the longitudinal or axial surface of each optical guide 222 and in optical communication with the diverting features. In other words, the diverting features herein may be configured to direct light within the optical guide 222 toward, for example, the distal end 222D of the guide or a nearby side, which is in optical communication with an optical window. The light window may include a portion of the light guide 222 that allows light to exit the light guide 222 from within the light guide 222, for example, a portion of the light guide 222 that does not have cladding material on or around the light guide 222.
[0099] Examples of redirection features suitable for use herein include reflective elements, refractive elements, and fiber diffusers. Furthermore, redirection features suitable for focusing light away from the tip of the optical guide 222 herein may include, but are not limited to, those having convex surfaces, gradient index (GRIN) lenses, and mirror focus lenses. Upon contact with the redirection feature, the light is redirected within the optical guide 222 to a photoacoustic transducer 254 that is in optical communication with the side of the optical guide 222. As noted above, the photoacoustic transducer 254 then converts the light energy into acoustic waves that extend away from the side of the optical guide 222.
[0100] The handle assembly 228 is handled and used by the user or operator to manipulate, position, and control the catheter 202. The design of the handle assembly 228 can be modified to conform to the design requirements of the catheter system 200. In the embodiment shown in Figure 2, the handle assembly 228 may include a circuit 256 that can form part of the system controller 126 (shown in Figure 1). Alternatively, the circuit 256 may transmit electrical signals, such as sensor signals or sensor outputs, to the system controller 126, or provide data in another form, as described herein. Additionally or alternatively, the circuit 256 may receive electrical signals or data from the pressure sensor assembly 242, for example, in the form of sensor signals or sensor outputs. In one embodiment, the circuit 256 may include one or more integrated circuits or a printed circuit board having any other suitable circuits. In alternative embodiments, the circuit 256 may be omitted or included within the system controller 126, which in various embodiments may be located outside the handle assembly 228, for example, inside the system console 123 (shown in Figure 1).
[0101] The pressure sensor assembly 242 is configured to sense and / or monitor the balloon pressure inside the balloon 246 of the balloon 204. As used herein, “balloon pressure” means the pressure inside the balloon 246 of the balloon 204 at the time, or substantially simultaneously with, the measurement of the pressure inside the balloon 246 of the balloon 204. In the embodiment shown in Figure 2, the pressure sensor assembly 242 can transmit an electrical signal to a circuit 256 in the handle assembly 228, which is then processed and transmitted to the system controller 126. In an alternative embodiment, the pressure sensor assembly 242 can transmit the electrical signal directly to the system controller 126. The design of the pressure sensor assembly 242 can be modified. In the embodiment shown in Figure 2, the pressure sensor assembly 242 includes a pressure sensor 258 and a transmission line 260. Alternatively, the pressure sensor assembly 242 may include more or fewer components than those specifically shown and described in relation to Figure 2.
[0102] The pressure sensor 258 can be positioned at any suitable location within the catheter system 200 to communicate with the balloon fluid 232 located inside the balloon 246 of the balloon 204. Thus, the pressure sensor 258, in conjunction with the electronics or optics in the handle assembly 242 and / or the system controller 126, is configured to provide real-time continuous monitoring of the balloon pressure inside the balloon 246.
[0103] In the embodiments shown in Figure 2 and in specific embodiments, the pressure sensor 258 can be substantially located inside the balloon 246 of the balloon 204. Such a design allows the pressure sensor 258 to directly sense, measure and / or monitor the balloon pressure inside the balloon 246 of the balloon 204. The pressure sensor 258 can then generate a sensor signal or sensor output, for example an electrical signal relating to the balloon pressure, and transmit it to the circuit 256 and / or system controller 126 via the transmission line 260. As will be described in more detail herein, the system controller 126 can then provide the user or operator with appropriate information regarding the operating status of the catheter system 200, for example, the success or failure of the energy source 124 firing, the possible rupture of the balloon 204, and / or the effectiveness of the treatment process by the catheter system 200, at least in part, based on the sensor signal received from the pressure sensor 258, for example via the GUI 127 (shown in Figure 1). Additionally, or alternatively, in some embodiments, if the sensor signal indicates a balloon rupture or that the energy source 124 is unable to fire as desired, the system controller 126 may be configured to automatically lock out the energy source 124 and thus cease the normal operation of the catheter system 200. Furthermore, or alternatively, the system controller 126 may be configured to process and integrate the sensor signal to determine and / or adjust the appropriate function of the catheter system 200 based at least in part on the sensor signal.
[0104] It is understood that the specific type of pressure sensor 258 included in the pressure sensor assembly 242 may vary. For example, in one non-exclusive embodiment, the pressure sensor 258 may be an optical fiber sensor directly incorporated into the balloon interior 246 of the balloon 204. Such an optical fiber sensor uses an optical fiber base or a "MEMS" interferometer attached to the distal end of the optical fiber. The cavity length of the interferometer is designed to vary with local pressure. The proximal end of the optical fiber may be connected to a laser controller, which has an optical system and a low-power laser to monitor changes in the fringe pattern in the interferometer. Changes in the fringe count directly correlate with pressure. Alternatively, another suitable type of pressure sensor 258 may be used.
[0105] Figure 3 is a schematic cross-sectional view of a portion of one embodiment of the catheter system 300, including another embodiment of the pressure sensor assembly 342. The design of the catheter system 300 is somewhat similar to the embodiments shown and described herein. In particular, in the embodiment shown in Figure 3, the catheter system 300 may again include a catheter shaft 310, a catheter 302 including a balloon 304 having a balloon wall 330 defining the balloon interior 346, a proximal balloon end 304P, and a distal balloon end 304D, balloon fluid 332 substantially held in the balloon interior 346, and a guidewire lumen 318 extending into the balloon interior 346; an energy guide 322 (sometimes referred to herein as an “optical guide”); a handle assembly 328; and a pressure sensor assembly 342. Alternatively, in other embodiments, the catheter system 300 may include more or fewer components than those specifically shown and described herein. For example, certain components shown in Figure 1, such as the guidewire 112, energy source 124 (sometimes referred to herein as the “light source”), system controller 126, GUI 127, supply source manifold 136, and fluid pump 138, are likely to be included in any embodiment of the catheter system 300, although they are not specifically shown in Figure 3 for clarity.
[0106] The catheter 302, including the catheter shaft 310, the balloon 304, and the guidewire lumen 318, is generally similar in design and operation to those described in detail above herein. Therefore, such components will not be described again in detail in relation to the embodiment shown in Figure 3. Furthermore, the optical guide 322 is also generally similar in design and function to those described above herein. Therefore, the optical guide 322 will also not be described again in detail in relation to the embodiment shown in Figure 3.
[0107] The balloon 304 is selectively movable between a folded configuration suitable for advancing the catheter 302 through the patient's vascular system and an extended configuration suitable for securing the catheter 302 in place relative to the treatment site 106 (shown in Figure 1). In some embodiments, the proximal end of the balloon 304P can be coupled here as well to the catheter shaft 310, and the distal end of the balloon 304D can be coupled here as well to the guidewire lumen 318. Furthermore, the balloon 304 can be inflated with balloon fluid 332 from a fluid pump 138 (shown in Figure 1), which is introduced into the balloon interior 346 of the balloon 304, for example, via an inflation conduit 140 (shown in Figure 1).
[0108] The handle assembly 328 is handled and used by the user or operator to manipulate, position, and control the catheter 302. The design of the handle assembly 328 can be modified to conform to the design requirements of the catheter system 300. In the embodiment shown in Figure 3, the handle assembly 328 may include a circuit 356 that can form part of the system controller 126 (shown in Figure 1). In this embodiment, the circuit 356 may be substantially similar in design and function to those described in previous embodiments. In alternative embodiments, the circuit 356 may be omitted or, in various embodiments, may be included within the system controller 126, which can be located outside the handle assembly 328, for example, inside the system console 123 (shown in Figure 1).
[0109] The pressure sensor assembly 342 is configured to sense and / or monitor the balloon pressure inside the balloon 346 of the balloon 304. Similar to the embodiments described above, the pressure sensor assembly 342 can transmit an electrical signal, such as a sensor signal or sensor output, to a circuit 356 in the handle assembly 328, which is then processed and sent to the system controller 126. Alternatively, the pressure sensor assembly 342 can transmit an electrical signal directly to the system controller 126.
[0110] The design of the pressure sensor assembly 342 can be modified. In the embodiment shown in Figure 3, the pressure sensor assembly 342 includes a pressure sensor 358, a transmission line 360, and a tubular member 362 that defines the sensor lumen (inside the tubular member 362). Alternatively, the pressure sensor assembly 342 may include more or fewer components than those specifically shown and described in relation to Figure 3. For example, in one non-exclusive alternative embodiment, the pressure sensor assembly 342 can be designed without the tubular member 362.
[0111] The pressure sensor 358 can be positioned at any suitable location within the catheter system 300 to communicate with the balloon fluid 332 located inside the balloon 346 of the balloon 304. Thus, the pressure sensor 358, in conjunction with the electronics or optics in the handle assembly 342 and / or the system controller 126, is configured to provide real-time continuous monitoring of the balloon pressure inside the balloon 346.
[0112] In certain embodiments, the pressure sensor 358 is located outside the balloon interior 346 of the balloon 304. In such embodiments, the pressure sensor 358 may be located inside the fluid channel of the catheter system 300, which includes the handle assembly 328 of the catheter 302, the end flattener, the irrigation tube, or the catheter shaft 310. Since the balloon fluid 332 in the balloon interior 346 is incompressible and communicates with the handle assembly 328 via the catheter shaft 310, the static fluid pressures in the catheter shaft 310, the balloon interior 346, and the handle assembly 328 are equal.
[0113] In the embodiment shown in Figure 3, the pressure sensor 358 is located within the handle assembly 328. Alternatively, the pressure sensor 358 can be located anywhere between the balloon 304 and the handle assembly 328. Even more alternatively, the pressure sensor 358 can be located between the handle assembly 328 and the system controller 126.
[0114] In various embodiments, the pressure sensor 358 is in fluid communication with the balloon fluid 332 inside the balloon 304, in the balloon interior 346. In the embodiment shown in Figure 3, the tubular member 362 extends from the pressure sensor 358 to the balloon interior 346. Thus, the pressure sensor 358 is in fluid communication with the balloon interior 346 via the tubular member 362. The tubular member 362 can be a relatively small diameter tube that can directly transmit the balloon pressure inside the balloon interior 346 to the pressure sensor 358. Alternatively, in embodiments that do not include the tubular member 362, the pressure sensor 358 can be in fluid communication with the balloon interior 346 via the catheter shaft 310.
[0115] Next, the pressure sensor 258 can generate a sensor signal or sensor output, such as an electrical signal relating to balloon pressure, and transmit it via the transmission line 260 to the circuit 256 and / or system controller 126. As described herein, the system controller 126 can then, at least in part, provide the user or operator with appropriate information regarding the operating status of the catheter system 300, such as the success or failure of the energy source 124 firing, the possible rupture of the balloon 304, and / or the effectiveness of the treatment process by the catheter system 300, via, for example, the GUI 127 (shown in Figure 1), based on the sensor signal received from the pressure sensor 358. Additionally, or alternatively, in some embodiments, if the sensor signal indicates a balloon rupture or that the energy source 124 cannot fire as desired, the system controller 126 can be configured to automatically lock out the energy source 124 and thus stop the normal operation of the catheter system 300. Furthermore, or as an alternative, the system controller 126 may be configured to process and integrate sensor signals to determine and / or adjust the appropriate function of the catheter system 300 based at least partially on the sensor signals.
[0116] The specific type of pressure sensor 358 included in the pressure sensor assembly 342 can vary. For example, in one non-exclusive embodiment, the pressure sensor 358 can be a conventional diaphragm or "MEMS" sensor that can be located inside the fluid channel from the handle assembly 328 to the balloon interior 346. As noted above, as a result of the incompressibility of the balloon fluid 332, the pressures in the catheter shaft 310, the balloon interior 346, and the handle assembly 328 are equal. Therefore, in some embodiments, the pressure sensor 358 can directly monitor and / or sense the fluid pressure at its location, which is considered to be substantially equal to the balloon pressure in the balloon interior 346. Thus, the pressure sensor assembly 342 can be designed without the tubular member 362, even when the pressure sensor 358 is located outside the balloon interior 346. Furthermore, the viscosity of the balloon fluid 332 moving through a narrow cross-section generates a time delay in the transmission of short-duration or transient events, such as pulses from pressure wave events. Alternatively, a fiber optic sensor, a diaphragm sensor, or any other suitable type of pressure sensor 358 can be used within the pressure sensor assembly 342.
[0117] Where used herein and in the appended claims, the singular forms “a,” “an,” and “it” refer to a plurality of objects unless the content and / or context clearly indicates otherwise. Also note that the term “or” is usually used in its sense to include “and / or” unless the content or context clearly indicates otherwise.
[0118] Where used herein and in the appended claims, the phrase “configured” should also be noted to describe a system, apparatus, or other structure that is built or configured to perform a particular task or to adopt a particular configuration. The phrase “configured” may be used interchangeably with other similar phrases such as arrangement and configuration, build and arrangement, build, manufacture and arrangement.
[0119] The headings used herein are provided for consistency with the proposals of 37 CFR 1.77 or to provide structural clues. These headings should not be considered to limit or characterize the invention as described in any claims that may be issued from this disclosure. For example, the description of the technology in “Background Art” does not constitute an acknowledgment that the technology to any invention in this disclosure is prior art. Nor should the “Summary” or “Abstract” be considered to characterize the invention as described in any issued claims.
[0120] The foregoing discussions of this disclosure are presented for illustrative and explanatory purposes only. The foregoing is not intended to limit this disclosure to any or any of the forms disclosed herein. For example, in the foregoing description, various features of this disclosure are grouped into one or more aspects, embodiments, and configurations for the purpose of simplifying the disclosure. Features of the aspects, embodiments, and configurations of this disclosure can be combined in alternative aspects, embodiments, and configurations other than those discussed above. This method of disclosure should not be interpreted as reflecting an intention that the claimed disclosure requires more features than expressly described in each claim. Rather, as reflected in the following claims, aspects of the invention are fewer than all the features of a single aforementioned disclosed aspect, embodiment, and configuration. Therefore, the following claims are incorporated herein, and each claim stands independently as a distinct preferred embodiment of this disclosure.
[0121] Furthermore, while the descriptions in this disclosure include descriptions of one or more aspects, embodiments, or configurations, as well as specific variations and modifications, other variations, combinations, and modifications are within the scope of this disclosure, for example, as they may be within the scope of the art and knowledge of those skilled in the art after understanding this disclosure. It is intended to obtain rights to a permissible range of alternative aspects, embodiments, and configurations, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps, whether or not such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and without intending to publicly monopolize the patentable subject matter.
[0122] The embodiments described herein are not intended to be exhaustive or to limit the invention to the exact forms disclosed in the detailed description provided herein. Rather, the embodiments are selected and described so that those skilled in the art can recognize and understand the principles and practices. Accordingly, the embodiments are described with reference to various specific preferred embodiments and techniques. However, it should be understood that many modifications and alterations are possible while remaining within the spirit and scope of this specification.
[0123] Although several different embodiments of the catheter system have been illustrated and described herein, it should be understood that one or more features of any one embodiment can be combined with one or more features of other embodiments, provided that such combinations satisfy the intent of the present invention.
[0124] While several exemplary embodiments and designs of catheter systems have been discussed above, those skilled in the art will recognize specific modifications, substitutions, additions, and subcombinations thereof. Therefore, the appended claims below and the claims introduced below are intended to be construed as including all such modifications, substitutions, additions, and subcombinations as they are in their true spirit and scope, and are not intended to limit the details of the configurations or designs shown herein.
Claims
1. A catheter system for destroying calcification in the wall of a blood vessel or a heart valve or in a treatment site adjacent to the wall of the blood vessel or the heart valve, An energy source that generates energy, comprising one of (i) a laser and (ii) a high-voltage energy source that provides high-voltage pulses, A balloon that can be positioned substantially adjacent to the treatment site, wherein the balloon has a balloon wall defining the interior of the balloon, and the interior of the balloon is configured to receive balloon fluid, An energy guide configured to receive energy from the energy source, configured to guide the energy into the balloon, and comprising (iii) an optical fiber and (iv) a pair of electrodes having spaced-out electrodes extending into the balloon, A pressure sensor configured to sense the balloon pressure of the balloon fluid inside the balloon, A handle assembly coupled to the balloon, positioned spaced apart from the balloon, usable by a user to operate the catheter system, and having the pressure sensor located within the handle assembly; A tubular member that enables fluid communication between the inside of the balloon and the pressure sensor, and which directly transmits the balloon pressure of the balloon fluid inside the balloon to the pressure sensor, A system controller is included, The pressure sensor is configured to generate a sensor signal based at least partially on the balloon pressure of the balloon fluid inside the balloon, the sensor signal is received by the system controller, and the system controller controls the operation of the catheter system based at least partially on the sensor signal. The aforementioned system controller The system is configured to detect the rupture of the balloon and to determine the effectiveness of the treatment based at least partially on the sensor signal. The energy includes an energy pulse that is guided along the energy guide into the balloon and induces plasma formation in the balloon fluid inside the balloon, A catheter system wherein the plasma formation causes rapid bubble formation, and a pressure wave is applied to the balloon wall adjacent to the treatment site.
2. The catheter system according to claim 1, wherein the pressure sensor is in fluid communication with the balloon fluid inside the balloon.
3. The catheter system according to claim 1 or 2, wherein the tubular member extends into the inside of the balloon.
4. The catheter system according to any one of claims 1 to 3, further comprising a graphic user interface, wherein the graphic user interface is configured to display one of static visual information and dynamic visual information based on the sensor signal.
5. The catheter system according to claim 4, wherein the graphic user interface is configured to provide a warning to stop using the catheter system.
6. A catheter system for destroying calcification in the wall of a blood vessel or a heart valve or in a treatment site adjacent to the wall of the blood vessel or the heart valve, Energy sources that generate energy, A balloon that can be positioned substantially adjacent to the treatment site, wherein the balloon has a balloon wall defining the interior of the balloon, and the interior of the balloon is configured to receive balloon fluid, An energy guide configured to receive energy from the energy source, and configured to guide the energy into the balloon, A pressure sensor configured to sense the balloon pressure of the balloon fluid inside the balloon, A handle assembly coupled to the balloon, positioned spaced apart from the balloon, and usable by a user to operate the catheter system, A tubular member that enables fluid communication between the inside of the balloon and the pressure sensor, and which directly transmits the balloon pressure of the balloon fluid inside the balloon to the pressure sensor, A system controller is included, The pressure sensor is configured to generate a sensor signal based at least partially on the balloon pressure of the balloon fluid inside the balloon, the sensor signal is received by the system controller, and the system controller controls the operation of the catheter system based at least partially on the sensor signal. The aforementioned system controller The system is configured to detect the rupture of the balloon and to determine the effectiveness of the treatment based at least partially on the sensor signal. The energy includes an energy pulse that is guided along the energy guide into the balloon and induces plasma formation in the balloon fluid inside the balloon, A catheter system wherein the plasma formation causes rapid bubble formation, and a pressure wave is applied to the balloon wall adjacent to the treatment site.
7. The catheter system according to claim 6, wherein the pressure sensor is in fluid communication with the balloon fluid inside the balloon.
8. The catheter system according to claim 6 or 7, wherein the tubular member extends into the inside of the balloon.
9. The catheter system according to any one of claims 6 to 8, further comprising a graphic user interface, wherein the graphic user interface is configured to display one of static visual information and dynamic visual information based on the sensor signal.
10. The catheter system according to claim 9, wherein the graphic user interface is configured to provide a warning to stop using the catheter system.
11. The catheter system according to any one of claims 6 to 10, wherein the energy source includes one of (i) a laser and (ii) a high-voltage energy source that provides high-voltage pulses.
12. The catheter system according to any one of claims 6 to 11, wherein the energy guide includes (iii) an optical fiber and (iv) a pair of electrodes having spaced-out electrodes extending into the balloon.
13. The catheter system according to any one of claims 6 to 12, wherein the pressure sensor is selected from the group consisting of an optical fiber sensor, a diaphragm sensor, and a MEMS sensor.
14. A catheter system for destroying calcification in the wall of a blood vessel or a heart valve or in a treatment site adjacent to the wall of the blood vessel or the heart valve, A light source that generates light energy, A balloon that can be positioned substantially adjacent to the treatment site, having a balloon wall that defines the inside of the balloon, and configured such that the inside of the balloon receives balloon fluid, and An optical guide configured to receive the light energy from the light source, comprising an optical guide that guides the light energy into the balloon, A handle assembly connected to the balloon, wherein the handle assembly is positioned spaced apart from the balloon, A pressure sensor disposed within the handle assembly, configured to sense the balloon pressure of the balloon fluid inside the balloon, and to generate a sensor signal based at least partially on the sensed balloon pressure of the balloon fluid inside the balloon, A system controller that receives the sensor signal and controls the operation of the catheter system based at least partially on the sensor signal, A tubular member extending into the balloon, configured to enable fluid communication between the inside of the balloon and the pressure sensor, and directly transmitting the balloon pressure of the balloon fluid inside the balloon to the pressure sensor, Equipped with, The aforementioned system controller The system is configured to detect the rupture of the balloon and to determine the effectiveness of the treatment based at least partially on the sensor signal. The light energy includes a light energy pulse that is guided along the light guide into the inside of the balloon and induces plasma formation in the balloon fluid inside the balloon, A catheter system wherein the plasma formation causes rapid bubble formation, and a pressure wave is applied to the balloon wall adjacent to the treatment site.