Patent Grant
12295654
Vascular lesions within vessels in the body can be associated with an increased risk for major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, and the like. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult to treat and achieve patency for a physician in a clinical setting.
Vascular lesions may be treated using interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, vascular graft bypass, to name a few. Such interventions may not always be ideal or may require subsequent treatment to address the lesion.
Intravascular lithotripsy is one method that has been recently used with some success for breaking up vascular lesions within vessels in the body. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics that are generated intravascularly in a fluid-filled balloon catheter. In particular, during a intravascular lithotripsy treatment, a high energy source is used to generate plasma and ultimately pressure waves as well as a rapid bubble expansion within a fluid-filled balloon to crack calcification at a lesion site within the vasculature. The associated rapid bubble formation from the plasma initiation and resulting localized fluid velocity within the balloon transfers mechanical energy through the incompressible fluid to impart a fracture force on the intravascular calcium, which is opposed to the balloon wall. The rapid change in fluid momentum upon hitting the balloon wall is known as hydraulic shock, or water hammer.
The generation of the plasma within the balloon interior can create a risk of rupture of the balloon due to the extremely high temperatures of the plasma. For example, plasma temperature can be greater than 4000° K, which is significantly higher than the melt temperature of traditional balloon materials. One limitation of creating a plasma within an angioplasty balloon, is risk of balloon rupture if the plasma is in close proximity to the balloon material, as the temperature of the plasma generated within the balloon is typically significantly greater than the melt temperature of traditional balloon materials. This is especially true in tortuous anatomy with severely calcified lesions of minimal lumen diameter such that before therapy, the catheter shaft is in very close proximity or touching the vessel wall. Thus, it is desired to develop means to minimize the possibility of balloon rupture due to the high temperatures of the plasma that is generated within the fluid-filled balloon so as to more effectively maintain catheter integrity.
The present invention is directed toward a catheter system for placement within a blood vessel or a heart valve. The catheter system can be used for treating a treatment site within or adjacent to the vessel wall or the heart valve. In various embodiments, the catheter system includes an energy source, a balloon, an energy guide, and a balloon integrity protection system. The energy source generates energy. The balloon is positionable substantially adjacent to the treatment site. The balloon has a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior. The energy guide is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior. The balloon integrity protection system is operatively coupled to the balloon. The balloon integrity protection system is configured to inhibit rupture of the balloon due to the plasma formed in the balloon fluid within the balloon interior during use of the catheter system.
In some embodiments, the catheter system further includes a plasma generator that is positioned at a guide distal end of the energy guide, the plasma generator being configured to generate the plasma in the balloon fluid within the balloon interior. In some embodiments, the plasma formation causes rapid bubble formation and imparts pressure waves upon the balloon wall adjacent to the treatment site.
In certain embodiments, the energy source generates pulses of energy that are guided along the energy guide into the balloon interior to induce the plasma formation in the balloon fluid within the balloon interior.
In some embodiments, the energy source is a laser source that provides pulses of laser energy. In such embodiments, the energy guide can include an optical fiber.
In certain embodiments, the energy source is a high voltage energy source that provides pulses of high voltage. In such embodiments, the energy guide can include an electrode pair including spaced apart electrodes that extend into the balloon interior; and pulses of high voltage from the energy source can be applied to the electrodes and form an electrical arc across the electrodes.
The present invention is also directed toward a method for treating a treatment site within or adjacent to a vessel wall utilizing the catheter system as described above.
In certain applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and a second balloon that is positioned to substantially completely encircle the balloon, the second balloon including a second balloon wall that is positioned such that a majority of the second balloon wall is positioned spaced apart from the balloon wall.
In some embodiments, the catheter system further includes a cooling fluid that is positioned substantially between the balloon wall and the second balloon wall. In such embodiments, the cooling fluid can be circulated between the balloon wall and the second balloon wall to maintain a balloon temperature of the second balloon wall below a melting temperature of the second balloon. In certain embodiments, the cooling fluid is formed from a mixture of saline and contrast medium. Alternatively, in other embodiments, the cooling fluid is formed from one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, and carbon dioxide.
In some applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and a second balloon that is positioned to substantially completely encircle the balloon, the second balloon including a second balloon wall that is positioned such that the second balloon wall is positioned substantially directly adjacent to the balloon wall.
In certain embodiments, the balloon is made from a first material and the second balloon is made from a second material that is different than the first material. In some such embodiments, the first material that is used to form the balloon has a higher melting temperature than the second material that is used to form the second balloon. For example, in such embodiments, the first material that is used to form the balloon can have a melting temperature that is at least approximately 10 degrees Kelvin higher than a second melting temperature of the second material that is used to form the second balloon. Further in such embodiments, the first material can be a silicone-based material.
In various embodiments, the first material that is used to form the balloon has a lower melting temperature than the second material that is used to form the second balloon. For example, in such embodiments, the first material that is used to form the balloon can have a melting temperature that is at least approximately 10 degrees Kelvin lower than a second melting temperature of the second material that is used to form the second balloon. Further, in such embodiments, the second material can be a silicone-based material.
The first material can be an open cell foam material. In some embodiments, at least one void formed within the open cell foam material is filled with an inflation material.
In certain embodiments, the catheter system further includes a third balloon that is positioned to substantially completely encircle the balloon, the third balloon being positioned substantially directly adjacent to the second balloon. In some such embodiments, the balloon is made from a first material, the second balloon is made from a second material, and the third balloon is made from a third material; and wherein at least one of the first material, the second material and the third material is different than the other materials. For example, in one such embodiment, the second material is different than each of the first material and the third material. In particular, in such embodiment, the second material can be configured to one of reflect and absorb light and heat. In certain such alternative embodiments, the second material is formed from one or more of a metallic foil, a carbon foil, and a closed-cell membrane filled with a fluid.
In certain applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and a composite material that is added onto a surface of the balloon.
In some embodiments, the composite material is added onto an inner surface of the balloon.
The catheter system can also include a plasma generator that is positioned at a guide distal end of the energy guide, the plasma generator being configured to generate the plasma in the balloon fluid within the balloon interior. In such embodiment, the composite material can be added onto an inner surface of the balloon near the plasma generator. Additionally, the composite material can be configured to one of reflect and absorb light and heat. In certain such embodiments, the composite material is formed from one or more of a metallic foil, a carbon foil, and a closed-cell membrane filled with a fluid.
In some applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and a braided material layer that is wrapped around a surface of the balloon to provide a braided balloon composite.
In certain embodiments, the braided material layer is wrapped around an outer surface of the balloon. Additionally, in some embodiments, the braided material layer is wrapped around the surface of the balloon to provide increased hoop and axial strength.
In some embodiments, the braided material layer is wrapped around the surface of the balloon in a manner so as to shorten the balloon upon inflation of the balloon. In another such embodiment, the braided material layer is configured to inhibit propagation of tears in the balloon.
In some embodiments, the braided material layer is formed from a high strength fiber such as nitinol, stainless steel, carbon, aramid, rayon, polyester, aromatic polyester (such as Vectran), nylon, natural (silk, wool, cotton and linen) fibers, and/or any other suitable materials.
In certain applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; and an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and wherein the balloon is formed as an electro-spun balloon. In such embodiments, the balloon is formed as an electro-spun balloon to increase a melting temperature of the balloon.
In some applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; and an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and wherein the balloon is formed from electrically conductive balloon material.
In certain applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; and an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and wherein the balloon is formed from thermally conductive balloon material.
In some applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; a catheter shaft that extends into the balloon interior, the balloon being coupled to the catheter shaft, the catheter shaft including a shaft recess; an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior; and a plasma generator that is positioned at a guide distal end of the energy guide, the plasma generator being configured to generate the plasma in the balloon fluid within the balloon interior; and wherein the energy guide is positioned such that the plasma generator is positioned substantially within the shaft recess.
In certain embodiments, the catheter shaft further includes at least one shaft projection that is positioned along the catheter shaft and about the plasma generator. In one such embodiment, the at least one shaft projection is positioned about the shaft recess.
In some embodiments, the catheter system further includes a protection cage that is fitted over the plasma generator. In such embodiments, the protection cage can be formed from one or more of a polymeric material and a metallic material.
In certain embodiments, the catheter system further includes a pair of separator balloons that are positioned about the catheter shaft at either end of the shaft recess. In some such embodiments, the separator balloons are configured to extend substantially completely from the catheter shaft to the balloon wall of the balloon on either side of the plasma generator when the separator balloons are inflated.
In some embodiments, the catheter system further includes one or more raised features that are molded onto a surface of the balloon. For example, in such embodiments, the one or more raised features can be molded onto an inner surface of the balloon. In certain such embodiments, the one or more raised features includes one or more circumferential raised features that extend about a circumference of the balloon. Additionally, or in the alternative, the one or more raised features includes one or more axial raised features that extend axial along the surface of the balloon.
In certain applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a catheter shaft that extends into the blood vessel, the catheter shaft including a shaft recess; an energy guide that is configured to receive energy from the energy source and guide the energy into the blood vessel; and a plasma generator that is positioned at a guide distal end of the energy guide, the plasma generator being configured to generate the plasma in a fluid within the blood vessel; and wherein the energy guide is positioned such that the plasma generator is positioned substantially within the shaft recess.
In some such embodiments, the catheter system further includes a pair of separator balloons that are positioned about the catheter shaft at either end of the shaft recess. Additionally, in such embodiments, the separator balloons can be configured to extend substantially completely from the catheter shaft to the vessel wall of the blood vessel on either side of the plasma generator when the separator balloons are inflated.
In some applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and leak plugging material that is distributed within the balloon interior, the leak plugging material being configured to plug leaks in the balloon if any leaks develop in the balloon during use of the catheter system.
In certain such embodiments, the leak plugging material is provided in the form of beads that are between approximately one μm and 100 μm in diameter. Additionally, in some embodiments, the leak plugging material is non-absorbable. Alternatively, in other embodiments, the leak plugging material is bio-absorbable.
In certain applications, the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve, the catheter system including an energy source that generates energy; a balloon that is positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; and an energy guide that is configured to receive energy from the energy source and guide the energy into the balloon interior so that plasma is formed in the balloon fluid within the balloon interior; and wherein the balloon is optically opaque.
The present invention is also directed toward a method for treating a treatment site within or adjacent to a vessel wall or heart valve, utilizing any of the catheter systems as described above.
The present invention is also directed toward a method for treating a treatment site within or adjacent to a vessel wall or heart valve, the method including the steps of generating energy with an energy source; positioning a balloon substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior; retaining a balloon fluid within the balloon interior; receiving energy from the energy source with an energy guide; guiding the energy into the balloon interior with the energy guide to form plasma in the balloon fluid within the balloon interior; and operatively coupling a balloon integrity protection system to the balloon, the balloon integrity protection system being configured to inhibit rupture of the balloon due to the plasma formed in the balloon fluid within the balloon interior during use of the catheter system.
This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
While embodiments of the present invention are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and are described in detail herein. It is understood, however, that the scope herein is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope herein.
Treatment of vascular lesions (also sometimes referred to herein as “treatment sites”) can reduce major adverse events or death in affected subjects. As referred to herein, a major adverse event is one that can occur anywhere within the body due to the presence of a vascular lesion. Major adverse events can include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vasculature, major adverse events in the brain, major adverse events in the musculature, or major adverse events in any of the internal organs.
The catheter systems and related methods disclosed herein are configured to minimize the possibility of balloon rupture and maintain catheter integrity when performing intravascular lithotripsy with a plasma generator. In various embodiments, the catheter systems and related methods of the present invention utilize a high energy source, e.g., in some embodiments, a light source such as a high energy laser source or another suitable high energy source, which provides energy that is guided by an energy guide, e.g., in some embodiments, a light guide, to create a localized plasma in the balloon fluid that is retained within a balloon interior of an inflatable balloon of the catheter. As such, the energy guide can sometimes be referred to as, or can be said to incorporate a “plasma generator” at or near a guide distal end of the energy guide that is positioned within the balloon interior. The creation of the localized plasma, in turn, induces a high energy bubble inside the balloon interior to create pressure waves to impart pressure onto and induce fractures in a vascular lesion, such as a calcified vascular lesion or a fibrous vascular lesion, at a treatment site within or adjacent to a blood vessel wall within a body of a patient. As used herein, the treatment site can include a vascular lesion such as a calcified vascular lesion or a fibrous vascular lesion, typically found in a blood vessel and/or a heart valve.
As used herein, the terms “intravascular lesion” and “vascular lesion” are used interchangeably unless otherwise noted. As such, the intravascular lesions and/or the vascular lesions are sometimes referred to herein simply as “lesions”.
Those of ordinary skill in the art will realize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations of the present invention as illustrated in the accompanying drawings.
In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it is appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.
It is appreciated that the catheter systems disclosed herein can include many different forms. Referring now to
The catheter 102 is configured to move to a treatment site 106 within or adjacent to a blood vessel 108 within a body 107 of a patient 109. The treatment site 106 can include one or more vascular lesions such as calcified vascular lesions, for example. Additionally, or in the alternative, the treatment site 106 can include vascular lesions such as fibrous vascular lesions.
The catheter 102 can include a balloon assembly 103 including an inflatable balloon 104 (sometimes referred to herein simply as a “balloon”), a catheter shaft 110 and a guidewire 112. The balloon 104 can be coupled to the catheter shaft 110. The balloon 104 can include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 can extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 can include a longitudinal axis 144. The catheter shaft 110 can also include a guidewire lumen 118 which is configured to move over the guidewire 112. As utilized herein, the guidewire lumen 118 is intended to define the structure that provides a conduit through which the guidewire extends. The catheter shaft 110 can further include an inflation lumen (not shown). In some embodiments, the catheter 102 can have a distal end opening 120 and can accommodate and be tracked over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106.
Importantly, as described in detail in various non-exclusive alternative embodiments herein below, the catheter system 100, the catheter 102 and/or the balloon assembly 103 can further include the balloon integrity protection system 142 that is operatively coupled to the balloon 104, the balloon integrity protection system 142 being configured to inhibit rupture or other damage to the balloon 104 during use of the catheter system 100. More particularly, in various embodiments, such as described in detail herein below, the balloon integrity protection system 142 can be incorporated into the balloon assembly 103 in order to more effectively protect the integrity of the balloon 104.
The catheter shaft 110 of the catheter 102 can be coupled to the one or more light guides 122A of the light guide bundle 122 that are in optical communication with the light source 124. The light guide(s) 122A can be disposed along the catheter shaft 110 and within the balloon 104. In some embodiments, each light guide 122A can be an optical fiber and the light source 124 can be a laser. The light source 124 can be in optical communication with the light guides 122A at the proximal portion 114 of the catheter system 100.
In some embodiments, the catheter shaft 110 can be coupled to multiple light guides 122A such as a first light guide, a second light guide, a third light guide, etc., which can be disposed at any suitable positions about the guidewire lumen 118 and/or the catheter shaft 110. For example, in certain non-exclusive embodiments, two light guides 122A can be spaced apart by approximately 180 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; three light guides 122A can be spaced apart by approximately 120 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; or four light guides 122A can be spaced apart by approximately 90 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110. Still alternatively, multiple light guides 122A need not be uniformly spaced apart from one another about the circumference of the guidewire lumen 118 and/or the catheter shaft 110. More particularly, it is further appreciated that the light guides 122A described herein can be disposed uniformly or non-uniformly about the guidewire lumen 118 and/or the catheter shaft 110 to achieve the desired effect in the desired locations.
The balloon 104 can include a balloon wall 130 that defines a balloon interior 146, and can be inflated with a balloon fluid 132 to expand from a deflated configuration suitable for advancing the catheter 102 through a patient's vasculature, to an inflated configuration suitable for anchoring the catheter 102 in position relative to the treatment site 106. Stated in another manner, when the balloon 104 is in the inflated configuration, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106, i.e. to the vascular lesion(s). It is appreciated that although
In some embodiments, the light source 124 of the catheter system 100 can be configured to provide sub-millisecond pulses of light from the light source 124, along the light guides 122A, to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the balloon fluid 132 within the balloon interior 146 of the balloon 104, i.e. via a plasma generator 133 located at a guide distal end 122D of the light guide 122A. The plasma formation causes rapid bubble formation, and imparts pressure waves upon the treatment site 106. Exemplary plasma-induced bubbles are shown as bubbles 134 in
It is appreciated that although the catheter systems 100 illustrated herein are generally described as including a light source 124 and one or more light guides 122A, the catheter system 100 can alternatively include any suitable energy source and energy guides for purposes of generating the desired plasma in the balloon fluid 132 within the balloon interior 146. For example, in one non-exclusive alternative embodiment, the energy source 124 can be configured to provide high voltage pulses, and each energy guide 122A can include an electrode pair including spaced apart electrodes that extend into the balloon interior 146. In such embodiment, each pulse of high voltage is applied to the electrodes and forms an electrical arc across the electrodes, which, in turn, generates the plasma and forms the pressure waves within the balloon fluid 132 that are utilized to provide the fracture force onto the vascular lesions at the treatment site 106. Still alternatively, the energy source 124 and/or the energy guides 122A can have another suitable design and/or configuration.
The balloons 104 suitable for use in the catheter systems 100 described in detail herein include those that can be passed through the vasculature of a patient when in the deflated configuration. In some embodiments, the balloons 104 herein are made from silicone. In other embodiments, the balloons 104 herein are made from polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX™ material available from Arkema, which has a location at King of Prussia, Pennsylvania, USA, nylon, and the like. In some embodiments, the balloons 104 can include those having diameters ranging from one millimeter (mm) to 25 mm in diameter. In some embodiments, the balloons 104 can include those having diameters ranging from at least 1.5 mm to 14 mm in diameter. In some embodiments, the balloons 104 can include those having diameters ranging from at least one mm to five mm in diameter.
Additionally, in some embodiments, the balloons 104 herein can include those having a length ranging from at least three mm to 300 mm. More particularly, in some embodiments, the balloons 104 herein can include those having a length ranging from at least eight mm to 200 mm. It is appreciated that balloons 104 of greater length can be positioned adjacent to larger treatment sites 106, and, thus, may be usable for imparting pressure onto and inducing fractures in larger vascular lesions or multiple vascular lesions at precise locations within the treatment site 106. It is further appreciated that such longer balloons 104 can also be positioned adjacent to multiple treatment sites 106 at any given time.
Further, the balloons 104 herein can be inflated to inflation pressures of between approximately one atmosphere (atm) and 70 atm. In some embodiments, the balloons 104 herein can be inflated to inflation pressures of from at least 20 atm to 70 atm. In other embodiments, the balloons 104 herein can be inflated to inflation pressures of from at least six atm to 20 atm. In still other embodiments, the balloons 104 herein can be inflated to inflation pressures of from at least three atm to 20 atm. In yet other embodiments, the balloons 104 herein can be inflated to inflation pressures of from at least two atm to ten atm.
Still further, the balloons 104 herein can include those having various shapes, including, but not to be 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 oval shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloons 104 herein can include a drug eluting coating or a drug eluting stent structure. The drug elution coating or drug eluting stent can include one or more therapeutic agents including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.
The balloon fluid 132 can be a liquid or a gas. Exemplary balloon fluids 132 suitable for use herein can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, and the like. In some embodiments, the balloon fluids 132 described can be used as base inflation fluids. In some embodiments, the balloon fluids 132 include a mixture of saline to contrast medium in a volume ratio of 50:50. In other embodiments, the balloon fluids 132 include a mixture of saline to contrast medium in a volume ratio of 25:75. In still other embodiments, the balloon fluids 132 include a mixture of saline to contrast medium in a volume ratio of 75:25. Additionally, the balloon fluids 132 suitable for use herein can be tailored on the basis of composition, viscosity, and the like in order to manipulate the rate of travel of the pressure waves therein. In certain embodiments, the balloon fluids 132 suitable for use herein are biocompatible. A volume of balloon fluid 132 can be tailored by the chosen light source 124 and the type of balloon fluid 132 used.
In some embodiments, the contrast agents used in the contrast media herein can include, but are not to be limited to, iodine-based contrast agents, such as ionic or non-ionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine based contrast agents can be used. Suitable non-iodine containing contrast agents can include gadolinium (III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents can include, but are not to be limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).
Additionally, the balloon fluids 132 herein can include those that include absorptive agents that can selectively absorb light in the ultraviolet region (e.g., at least ten 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 absorptive agents can include those with absorption maxima along the spectrum from at least ten nm to 2.5 μm. Alternatively, the balloon fluids 132 can include those that include absorptive agents 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 one mm) of the electromagnetic spectrum. In various embodiments, the absorptive agent can be those that have an absorption maximum matched with the emission maximum of the laser used in the catheter system 100. By way of non-limiting examples, various lasers described herein can 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 absorptive agents used herein can be water soluble. In other embodiments, the absorptive agents used herein are not water soluble. In some embodiments, the absorptive agents used in the balloon fluids 132 herein can be tailored to match the peak emission of the light source 124. Various light sources 124 having emission wavelengths of at least ten nanometers to one millimeter are discussed elsewhere herein.
It is appreciated that the catheter system 100 and/or the light guide bundle 122 disclosed herein can include any number of light guides 122A in optical communication with the light source 124 at the proximal portion 114, and with the balloon 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 light guide bundle 122 can include from one light guide 122A to five light guides 122A. In other embodiments, the catheter system 100 and/or the light guide bundle 122 can include from five light guides 122A to fifteen light guides 122A. In yet other embodiments, the catheter system 100 and/or the light guide bundle 122 can include from ten light guides 122A to thirty light guides 122A. Alternatively, in still other embodiments, the catheter system 100 and/or the light guide bundle 122 can include greater than thirty light guides 122A.
The light guides 122A herein can include an optical fiber or flexible light pipe. The light guides 122A herein can be thin and flexible and can allow light signals to be sent with very little loss of strength. The light guides 122A herein can include a core surrounded by a cladding about its circumference. In some embodiments, the core can be a cylindrical core or a partially cylindrical core. The core and cladding of the light guides 122A can be formed from one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers. The light guides 122A may also include a protective coating, such as a polymer. It is appreciated that the index of refraction of the core will be greater than the index of refraction of the cladding.
Each light guide 122A can guide light along its length from a proximal portion, i.e. a guide proximal end 122P, to a distal portion, i.e. the guide distal end 122D, having at least one optical window (not shown) that is positioned within the balloon interior 146. The light guides 122A can create a light path as a portion of an optical network including the light source 124. The light path within the optical network allows light to travel from one part of the network to another. Both the optical fiber and the flexible light pipe can provide a light path within the optical networks herein.
Further, the light guides 122A herein can assume many configurations about and/or relative to the catheter shaft 110 of the catheters 102 described herein. In some embodiments, the light guides 122A can run parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the light guides 122A can be physically coupled to the catheter shaft 110. In other embodiments, the light guides 122A can be disposed along a length of an outer diameter of the catheter shaft 110. In yet other embodiments, the light guides 122A herein can be disposed within one or more light guide lumens within the catheter shaft 110.
Additionally, it is further appreciated that the light guides 122A can be disposed at any suitable positions about the circumference of the guidewire lumen 118 and/or the catheter shaft 110, and the guide distal end 122D of each of the light guides 122A can be disposed at any suitable longitudinal position relative to the length of the balloon 104 and/or relative to the length of the guidewire lumen 118.
Further, the light guides 122A herein can include one or more photoacoustic transducers 154, where each photoacoustic transducer 154 can be in optical communication with the light guide 122A within which it is disposed. In some embodiments, the photoacoustic transducers 154 can be in optical communication with the guide distal end 122D of the light guide 122A. Additionally, in such embodiments, the photoacoustic transducers 154 can have a shape that corresponds with and/or conforms to the guide distal end 122D of the light guide 122A.
The photoacoustic transducer 154 is configured to convert light energy into an acoustic wave at or near the guide distal end 122D of the light guide 122A. It is appreciated that the direction of the acoustic wave can be tailored by changing an angle of the guide distal end 122D of the light guide 122A.
It is further appreciated that the photoacoustic transducers 154 disposed at the guide distal end 122D of the light guide 122A herein can assume the same shape as the guide distal end 122D of the light guide 122A. For example, in certain 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 half-circle shape, an ovoid shape, and the like. It is also appreciated that the light guide 122A can further include additional photoacoustic transducers 154 disposed along one or more side surfaces of the length of the light guide 122A.
The light guides 122A described herein can further include one or more diverting features or “diverters” (not shown in
Examples of the diverting features suitable for use herein include a reflecting element, a refracting element, and a fiber diffuser. Additionally, the diverting features suitable for focusing light away from the tip of the light guides 122A herein can include, but are not to be limited to, those having a convex surface, a gradient-index (GRIN) lens, and a mirror focus lens. Upon contact with the diverting feature, the light is diverted within the light guide 122A to the plasma generator 133 and/or the photoacoustic transducer(s) 154 that are in optical communication with a side surface of the light guide 122A. As noted, the plasma generator 133 and/or the photoacoustic transducer(s) 154 then convert light energy into an acoustic pressure wave and bubble that extend away from the side surface of the light guide 122A.
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 end openings that can receive the plurality of light guides 122A of the light guide bundle 122, the guidewire 112, and/or an inflation conduit 140 that is coupled in fluid communication with the fluid pump 138. The catheter system 100 can also include the fluid pump 138 that is configured to inflate the balloon 104 with the balloon fluid 132, i.e. via the inflation conduit 140, as needed.
As noted above, in the embodiment illustrated in
Additionally, as shown, the system console 123, and the components included therewith, is operatively coupled to the catheter 102, the light guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as illustrated in
Further, the light guide bundle 122 can also include a guide bundler 152 (or “shell”) that brings each of the individual light guides 122A closer together so that the light guides 122A and/or the light guide bundle 122 can be in a more compact form as it extends with the catheter 102 into the blood vessel 108 during use of the catheter system 100.
As provided herein, the light source 124 can be selectively and/or alternatively coupled in optical communication with each of the light guides 122A, i.e. to the guide proximal end 122P of each of the light guides 122A, in the light guide bundle 122. In particular, the light source 124 is configured to generate light energy in the form of a source beam 124A, e.g., a pulsed source beam, that can be selectively and/or alternatively directed to and received by each of the light guides 122A in the light guide bundle 122 as an individual guide beam 1248. Alternatively, the catheter system 100 can include more than one light source 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate light source 124 for each of the light guides 122A in the light guide bundle 122.
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 that are focused onto a small spot in order to couple it into the guide proximal end 122P of the light guide 122A. Such pulses of light energy are then directed along the light guides 122A to a location within the balloon 104, thereby inducing plasma formation in the balloon fluid 132 within the balloon interior 146 of the balloon 104. In particular, the light energy emitted at the guide distal end 122D of the light guide 122A energizes the plasma generator 133 to form the plasma within the balloon fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation, and imparts pressure waves upon 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 of between approximately one hertz (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 of 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 of between approximately ten Hz and 100 Hz. In yet other embodiments, the sub-millisecond pulses of light from the light source 124 can be delivered to the treatment site 106 at a frequency of between approximately one Hz and 30 Hz. Alternatively, the sub-millisecond pulses of light can be delivered to the treatment site 106 at a frequency that can be greater than 5000 Hz.
It is appreciated that although the light source 124 is typically utilized to provide pulses of light energy, the light source 124 can still be described as providing a single source beam 124A, i.e. a single pulsed source beam.
The light sources 124 suitable for use herein can include various types of light sources including lasers and lamps. Alternatively, as noted above, the light sources 124, as referred to herein, can include any suitable type of energy source.
Suitable lasers can include short pulse lasers on the sub-millisecond timescale. In some embodiments, the light source 124 can include lasers on the nanosecond (ns) timescale. The lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is appreciated that there are many combinations of laser wavelengths, pulse widths and energy levels that can be employed to achieve plasma in the balloon fluid 132 of the catheters 102 described herein. In various embodiments, the pulse widths can include those falling within a range including from at least ten ns to 2000 ns. In some embodiments, the pulse widths can include those falling within a range including from at least 20 ns to 100 ns. In other embodiments, the pulse widths can include those falling within a range including from at least one ns to 500 ns.
Additionally, exemplary nanosecond lasers can include those within the UV to IR spectrum, spanning wavelengths of about ten nanometers (nm) to one millimeter (mm). In some embodiments, the light sources 124 suitable for use in the catheter systems 100 herein can include those capable of producing light at wavelengths of from at least 750 nm to 2000 nm. In other embodiments, the light sources 124 can include those capable of producing light at wavelengths of from at least 700 nm to 3000 nm. In still other embodiments, the light sources 124 can include those capable of producing light at wavelengths of from at least 100 nm to ten micrometers (μm). Nanosecond lasers can include those having repetition rates of up to 200 kHz. In some embodiments, the laser can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser. In other embodiments, the laser can include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, holmium:yttrium-aluminum-garnet (Ho:YAG) laser, erbium:yttrium-aluminum-garnet (Er:YAG) laser, excimer laser, helium-neon laser, carbon dioxide laser, as well as doped, pulsed, fiber lasers.
The catheter systems 100 disclosed herein can generate pressure waves having maximum pressures in the range of at least one megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 will depend 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 systems 100 herein can generate pressure waves having maximum pressures in the range of at least two MPa to 50 MPa. In other embodiments, the catheter systems 100 herein can generate pressure waves having maximum pressures in the range of at least two MPa to 30 MPa. In yet other embodiments, the catheter systems 100 herein can generate pressure waves having maximum pressures in the range of at least 15 MPa to 25 MPa.
The pressure waves described herein can be imparted upon the treatment site 106 from a distance within a range from at least 0.1 millimeters (mm) to 25 mm extending radially from the light guides 122A when the catheter 102 is placed at the treatment site 106. In some embodiments, the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least ten mm to 20 mm extending radially from the light guides 122A when the catheter 102 is placed at the treatment site 106. In other embodiments, the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least one mm to ten mm extending radially from the light guides 122A when the catheter 102 is placed at the treatment site 106. In yet other embodiments, the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least 1.5 mm to four mm extending radially from the light guides 122A when the catheter 102 is placed at the treatment site 106. In some embodiments, the pressure waves can be imparted upon the treatment site 106 from a range of at least two MPa to 30 MPa at a distance from 0.1 mm to ten mm. In some embodiments, the pressure waves can be imparted upon the treatment site 106 from a range of at least two MPa to 25 MPa at a distance from 0.1 mm to ten mm.
The power source 125 is electrically coupled to and is configured to provide necessary power to each of the light source 124, the system controller 126, the GUI 127, and the handle assembly 128. The power source 125 can have any suitable design for such purposes.
As noted, the system controller 126 is electrically coupled to and receives power from the power source 125. Additionally, the system controller 126 is coupled to and is configured to control operation of each of the light source 124 and the GUI 127. The system controller 126 can include one or more processors or circuits for purposes of controlling the operation of at least the light source 124 and the GUI 127. For example, the system controller 126 can control the light source 124 for generating pulses of light energy as desired, e.g., at any desired firing rate.
Additionally, the system controller 126 can further be configured to control operation of other components of the catheter system 100, e.g., the positioning of the catheter 102 adjacent to the treatment site 106, the inflation of the balloon 104 with the balloon fluid 132, etc. Further, or in the alternative, the catheter system 100 can include one or more additional controllers that can be positioned in any suitable manner for purposes of controlling the various operations of the catheter system 100. For example, in certain embodiments, an additional controller and/or a portion of the system controller 126 can be positioned and/or incorporated within the handle assembly 128.
The GUI 127 is accessible by the user or operator of the catheter system 100. Additionally, the GUI 127 is electrically connected to the system controller 126. With such design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is employed as desired to impart pressure onto and induce fractures into the vascular lesions at the treatment site 106. 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 static visual data and/or information to the user or operator. In addition, or in the alternative, the GUI 127 can provide dynamic visual data and/or information to the user or operator, such as video data or any other data that changes over time, e.g., during use of the catheter system 100. Further, in various embodiments, the GUI 127 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the user or operator. Additionally, or in the alternative, the GUI 127 can provide audio data or information to the user or operator. It is appreciated that the specifics of the GUI 127 can vary depending upon the design requirements of the catheter system 100, or the specific needs, specifications and/or desires of the user or operator.
As shown in
The handle assembly 128 is handled and used by the user or operator to operate, position and control the catheter 102. The design and specific features of the handle assembly 128 can vary to suit the design requirements of the catheter system 100. In the embodiment illustrated in
In one embodiment, the circuitry 156 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In an alternative embodiment, the circuitry 156 can be omitted, or can be included within the system controller 126, which in various embodiments can be positioned outside of the handle assembly 128, e.g., within the system console 123. It is understood that the handle assembly 128 can include fewer or additional components than those specifically illustrated and described herein.
As noted above, in various embodiments, the balloon integrity protection system 142 can be included with and/or incorporated into the catheter system 100, the catheter 102 and/or the balloon assembly 103 in order to inhibit rupture or other damage to the balloon 104 during use of the catheter system 100 in order to more effectively protect the integrity of the balloon 104. Various embodiments of the balloon integrity protection system 142 are described in greater detail herein below in relation to
The catheter 202, including the catheter shaft 210, the balloon 204, and the guidewire lumen 218, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 204 is selectively movable between a deflated configuration suitable for advancing the catheter 202 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 202 in position relative to the treatment site 106 (illustrated in
As provided herein, the balloon integrity protection system 242 can have any suitable design for purposes of inhibiting rupture or other damage to the balloon 204 or otherwise protecting the integrity of the balloon 204 during use of the catheter system 200. For example, as shown in the embodiment illustrated in
As illustrated in
Additionally, as shown, the cooling fluid 262 is positioned substantially between the balloon wall 230 of the balloon 204 and the second balloon wall 260W of the second balloon 260. In this embodiment, the cooling fluid 262 is circulated between the balloon wall 230 and the second balloon wall 260W to maintain a balloon temperature, e.g., at the second balloon wall 260W, which is below a melting temperature of the second balloon 260. More particularly, with such design, the second balloon 260 is better protected from any increases in temperature in the event that the balloon 204 may rupture or otherwise become damaged during use of the catheter system 200.
The cooling fluid 262 can be formed from any suitable fluid materials. In certain embodiments, the cooling fluid 262 can be formed from the same or similar materials that are used for the balloon fluid 232. For example, in one non-exclusive embodiment, the cooling fluid 262 is formed from a mixture of saline and contrast medium. Alternatively, in other non-exclusive embodiments, the cooling fluid 262 can be formed from water, saline, contrast medium, fluorocarbons, perfluorocarbons, and/or gases, such as carbon dioxide, and the like. Still alternatively, the cooling fluid 262 can be formed from other suitable materials.
The catheter 302, including the catheter shaft 310, the balloon 304, and the guidewire lumen 318, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 304 is selectively movable between a deflated configuration suitable for advancing the catheter 302 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 302 in position relative to the treatment site 106 (illustrated in
Further, in this embodiment, the balloon integrity protection system 342 is substantially similar to the embodiment illustrated and described in relation to
The catheter 402, including the catheter shaft 410, the balloon 404, and the guidewire lumen 418, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 404 is selectively movable between a deflated configuration suitable for advancing the catheter 402 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 402 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 442 is somewhat different than in the previous embodiments. In particular, as shown in
In this embodiment, the balloon 404 and the second balloon 460 are formed from different materials from one another. More particularly, in this embodiment, the balloon 404 has a higher melting temperature than the second balloon 460. It is appreciated, however, that the balloon 404 may require the semi-compliance of the second balloon 460 for strength purposes. With such design, the balloon 404 can function to provide desired insulation for the balloon assembly 403, while the second balloon 460 can be utilized to provide pressure containment for the balloon assembly 403.
In one non-exclusive alternative embodiment, the balloon 404 can be formed from a silicone-based material, which has a high melt temperature (e.g., in certain applications around 1700K or similar), and the second balloon 460 can be formed from a more traditional balloon material such as PEBAX™, which has a lower melt temperature (e.g., around 450K or similar). Alternatively, the balloon 404 and/or the second balloon 460 can be formed from other suitable materials, so long as the balloon 404 has a higher melt temperature than the second balloon 460. In certain non-exclusive embodiments, the melt temperature of the balloon 404 can be at least approximately 10, 25, 50, 75, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, or 1500 degrees Kelvin higher than the melt temperature of the second balloon 460.
The catheter 502, including the catheter shaft 510, the balloon 504, and the guidewire lumen 518, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 504 is selectively movable between a deflated configuration suitable for advancing the catheter 502 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 502 in position relative to the treatment site 106 (illustrated in
Further, in this embodiment, the balloon integrity protection system 542 is substantially similar to the embodiment illustrated and described in relation to
In this embodiment, the balloon 504 and the second balloon 560 are again formed from different materials from one another. However, in this embodiment, the balloon 504 has a lower melting temperature than the second balloon 560. With such design, the balloon 504 is configured to provide the required semi-compliant strength, while the second balloon 560 serves to maintain pressure in the event of the plasma melting or otherwise damaging the balloon 504.
In one non-exclusive alternative embodiment, the balloon 504 can be formed from a more traditional balloon material such as PEBAX™, which has a lower melt temperature (e.g., around 450K or similar), and the second balloon 560 can be formed from a silicone-based material, which has a high melt temperature (e.g., in certain applications around 1700K or similar). Alternatively, the balloon 504 and/or the second balloon 560 can be formed from other suitable materials, so long as the balloon 504 has a lower melt temperature than the second balloon 560. In certain non-exclusive embodiments, the melt temperature of the balloon 504 can be at least approximately 10, 25, 50, 75, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, or 1500 degrees Kelvin lower than the melt temperature of the second balloon 560.
The catheter 602, including the catheter shaft 610, the balloon 604, and the guidewire lumen 618, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 604 is selectively movable between a deflated configuration suitable for advancing the catheter 602 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 602 in position relative to the treatment site 106 (illustrated in
Further, in this embodiment, the balloon integrity protection system 642 is somewhat similar to the embodiments illustrated and described in relation to
In this embodiment, the balloon 604 and the second balloon 660 are again formed from different materials from one another. More particularly, in this embodiment, the balloon 604 can be formed from an open cell foam material and the second balloon 660 can be formed from a more traditional balloon material, e.g., PEBAX™. As described in this embodiment, the open cell foam material of the balloon 604 serves to separate the balloon material of the second balloon 660 from the plasma that is being formed within the balloon fluid 632 within the balloon interior 646. Additionally, in one such embodiment, voids that are formed within the open cell foam material of the balloon 604 can be filled with an inflation media that serves as an additional insulation layer between the plasma and the balloon material of the second balloon 660.
The catheter 702, including the catheter shaft 710, the balloon 704, and the guidewire lumen 718, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 704 is selectively movable between a deflated configuration suitable for advancing the catheter 702 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 702 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 742 is somewhat different than in the previous embodiments. In particular, as shown in
In this embodiment, the balloon 704 and the third balloon 764 can be formed from more traditional balloon materials, e.g., PEBAX™ or another suitable balloon material, and the second balloon 760 can be formed from a non-traditional balloon material. In such embodiment, the non-traditional balloon material of the second balloon 760 (i.e. the middle balloon) can be configured to reflect and/or absorb light and heat that may be generated in the balloon assembly 703. In certain non-exclusive alternative embodiments, the second balloon 760 can be formed from one or more of a metallic foil, a carbon foil, a closed cell membrane filled with gas or liquid, or another suitable material that can reflect/absorb light and heat.
The catheter 802, including the catheter shaft 810, the balloon 804, and the guidewire lumen 818, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 804 is selectively movable between a deflated configuration suitable for advancing the catheter 802 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 802 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 842 is somewhat different than in the previous embodiments. In particular, as shown in
The material for the composite material 866 can be varied to suit the specific requirements of the catheter system 800, the balloon assembly 803 and/or the balloon integrity protection system 842. In certain embodiments, the composite material 866 may be formed from a material having a higher melt temperature and/or having the ability to absorb/reflect light and heat substantially better than the native balloon material that is used to form the balloon 804. In certain non-exclusive alternative embodiments, the composite material 866 can be formed from one or more of a metallic foil, a carbon foil, a closed cell membrane filled with gas or liquid, or another suitable material that can reflect/absorb light and heat.
Additionally, it is appreciated that the composite material 866 can be added onto the surface 804S of the balloon 804 using any appropriate methods and/or machinery. For example, one non-exclusive machine capable of such operation is a PLA Giken Extruder, available from PLA Giken Co., Ltd., of Osaka, Japan. Alternatively, the composite material 866 can be added onto the surface 804S of the balloon 804 using another appropriate method or machine.
The catheter 902, including the catheter shaft 910, the balloon 904, and the guidewire lumen 918, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 904 is selectively movable between a deflated configuration suitable for advancing the catheter 902 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 902 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 942 is somewhat different than in the previous embodiments. In particular, as shown in
Additionally, in this embodiment, the braid pattern for the braided material layer 968 can be wrapped in such a manner such that it is specifically configured to shorten the balloon 904 upon inflation of the balloon 904. More particularly, in such embodiment, as the balloon 904 shortens during inflation, the catheter shaft 910 is flexed away from the wall of the blood vessel 108 (illustrated in
It is appreciated that the braided material layer 968 can be formed from any suitable materials. For example, in certain non-exclusive alternative embodiments, the braided material layer 968 can be formed from one or more of nitinol, stainless steel, carbon, aramid, rayon, polyester, aromatic polyester (such as Vectran), nylon, and natural (silk, wool, cotton and linen) fibers and/or other suitable materials.
The catheter 1002, including the catheter shaft 1010, the balloon 1004, and the guidewire lumen 1018, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1004 is selectively movable between a deflated configuration suitable for advancing the catheter 1002 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1002 in position relative to the treatment site 106 (illustrated in
Further, in this embodiment, the balloon integrity protection system 1042 is somewhat similar to the embodiment illustrated and described in relation to
Additionally, in this embodiment, the braided material layer 1068 may further be wrapped in such a manner so as to cause the catheter shaft 1010 to flex away from the wall of the blood vessel 108 (illustrated in
It is appreciated that the braided material layer 1068 can be formed from any suitable materials. For example, in certain non-exclusive alternative embodiments, the braided material layer 1068 can be formed from one or more of nitinol, stainless steel, carbon, aramid, rayon, polyester, aromatic polyester (such as Vectran), nylon, and natural (silk, wool, cotton and linen) fibers and/or other suitable materials.
The catheter 1102, including the catheter shaft 1110, the balloon 1104, and the guidewire lumen 1118, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1104 is selectively movable between a deflated configuration suitable for advancing the catheter 1102 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1102 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1142 is somewhat different than in the previous embodiments. In particular, as shown in
In such embodiment, it is appreciated that the balloon 1104 can be formed as a gas-tight braided balloon, i.e. with a melt temperature that is significantly higher than the melt temperature for traditional balloon materials. As such, the electro-spun balloon material provides greater temperature protection against plasma than traditional balloon materials. Additionally, it is further appreciated that in different embodiments, the electro-spun balloon material can be used alone or as a composite with traditional balloon materials.
The catheter 1202, including the catheter shaft 1210, the balloon 1204, and the guidewire lumen 1218, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1204 is selectively movable between a deflated configuration suitable for advancing the catheter 1202 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1202 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1242 is somewhat different than in the previous embodiments. In particular, as shown in
With such design, in the event that an arc plasma contacts the balloon 1204, the material used for the balloon 1204 can function to spread the distribution of charge to thus minimize focused electrocution or electrocautery.
The catheter 1302, including the catheter shaft 1310, the balloon 1304, and the guidewire lumen 1318, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1304 is selectively movable between a deflated configuration suitable for advancing the catheter 1302 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1302 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1342 is somewhat different than in the previous embodiments. In particular, as shown in
It is appreciated that the balloon 1304 can be formed from any suitable thermally conductive balloon materials. For example, in certain non-exclusive alternative embodiments, the balloon 1304 can be formed from one or more of graphite, aluminum nitride and/or boron nitride mixed with polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX™, nylon and/or other suitable thermally conductive balloon materials.
The catheter 1402, including the catheter shaft 1410, the balloon 1404, and the guidewire lumen, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1404 is selectively movable between a deflated configuration suitable for advancing the catheter 1402 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1402 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1442 is somewhat different than in the previous embodiments. In particular, as shown in
In this embodiment, the shaft recess 1470 entails removing material from the catheter shaft 1410 and positioning the light guide 1422A such that the plasma generator 1433 is positioned substantially within the shaft recess 1470. With such design, the plasma generator 1433, and thus the plasma that is generated in the balloon fluid 1432 within the balloon interior 1446, is maintained a greater distance separated from the balloon 1404.
Additionally, as shown, the at least one shaft projection 1472 can be positioned along the catheter shaft 1410 and about the plasma generator 1433, e.g., about the shaft recess 1470, to better separate the plasma generator 1433, and thus the plasma that is generated in the balloon fluid 1432 within the balloon interior 1446, from at least certain portions of the balloon 1404.
It is appreciated that with an increased separation between the plasma generator 1433, and thus the plasma, from the balloon 1404, the balloon 1404 will be less susceptible to potential rupture or other damage due to the heat generated by the formation of the plasma in the balloon fluid 1432.
The catheter 1502, including the catheter shaft 1510, the balloon 1504, and the guidewire lumen, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1504 is selectively movable between a deflated configuration suitable for advancing the catheter 1502 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1502 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1542 is somewhat different than in the previous embodiments. In particular, similar to the embodiment illustrated in
Additionally, as also shown in
The protection cage 1574 can be formed from any suitable materials. For example, in certain non-exclusive alternative embodiments, the protection cage 1574 can be formed from one or more of a polymeric material, a metallic material (e.g., nitinol), or other suitable materials.
As with the previous embodiment, it is appreciated that with an increased separation between the plasma generator 1533, and thus the plasma, from the balloon 1504, the balloon 1504 will be less susceptible to potential rupture or other damage due to the heat generated by the formation of the plasma in the balloon fluid 1532.
The catheter 1602, including the catheter shaft 1610, the balloon 1604, and the guidewire lumen, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1604 is selectively movable between a deflated configuration suitable for advancing the catheter 1602 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1602 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1642 is somewhat different than in the previous embodiments. In particular, similar to the embodiments illustrated in
Additionally, in the embodiment illustrated in
As noted herein, any additional separation between the plasma and the balloon 1604 can result in the balloon 1604 being less susceptible to potential rupture or other damage due to the heat generated by the formation of the plasma in the balloon fluid 1632.
The catheter 1702, including the catheter shaft 1710, and the guidewire lumen, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
Additionally, the balloon fluid 1732, e.g., from the fluid pump 138 (illustrated in
As illustrated in this embodiment, the vessel integrity protection system 1778 is substantially similar to the balloon integrity protection system 1642 illustrated and described in relation to
As shown, the shaft recess 1770 is again formed into the catheter shaft 1710, e.g., about a circumference of the catheter shaft 1710. With such design, the energy guides 1722A can be positioned within the shaft recess 1770 so that the energy guides 1722A are positioned with a greater separation distance relative to the blood vessel 108.
Additionally, in this embodiment, the separator balloons 1776 are again positioned about the catheter shaft 1710 at either end of the shaft recess 1770. The separator balloons 1776 are configured to, when inflated, extend substantially completely from the catheter shaft 1710 to the wall of the blood vessel 108 on either side of the plasma generator 1733. With such design, the plasma that is generated in the balloon fluid 1732 will be effectively restrained within the area between the separator balloons 1776. As such, the separator balloons 1776 effectively provide a recess for the plasma and further provide a seal against the wall of the blood vessel 108 creating a volume to perform intravascular lithotripsy. Thus, the plasma and the resulting pressure waves can be more restricted to be directed toward intravascular lesions to be treated.
Further, the separator balloons 1776 may additionally serve to shift the catheter shaft 1710 away from the wall of the blood vessel 108. It is appreciated that any additional separation between the plasma and the wall of the blood vessel 108 will help protect the blood vessel 108 from being potentially damaged by the plasma.
The catheter 1802, including the catheter shaft 1810, the balloon 1804, and the guidewire lumen, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1804 is selectively movable between a deflated configuration suitable for advancing the catheter 1802 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1802 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1842 is somewhat different than in the previous embodiments. In particular, similar to the embodiments illustrated in
Additionally, in the embodiment illustrated in
The material for the raised features 1880 can be varied to suit the specific requirements of the catheter system 1800, the balloon assembly 1803 and/or the balloon integrity protection system 1842. For example, in certain non-exclusive alternative embodiments, the raised features 1880 can be formed from standard balloon materials such as polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX™ or nylon. Still alternatively, the raised features 1880 can be formed from one or more of Nitinol, stainless steel, carbon, aramid, rayon, polyester, nylon, and natural (silk, wool, cotton and linen) fibers, Polyacetylene, polypyrrole, polyindole, polyaniline, poly(p-phenylene vinylene), poly(thiophene), poly(3,4-ethylenedioxythiophene), poly(p-phenylene sulfide), or other suitable materials.
As noted herein, any additional separation between the plasma and the balloon 1804 can result in the balloon 1804 being less susceptible to potential rupture or other damage due to the heat generated by the formation of the plasma in the balloon fluid 1832.
The catheter 1902, including the catheter shaft 1910, the balloon 1904, and the guidewire lumen 1918, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 1904 is selectively movable between a deflated configuration suitable for advancing the catheter 1902 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 1902 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 1942 is somewhat different than in the previous embodiments. In particular, as shown in
During use of the catheter system 1900, if the plasma melts a hole in the balloon wall 1930, the leak plugging material 1982 will migrate through the hole to plug the leak in order to inhibit propagation of the holes and/or rupture of the balloon 1904. It is appreciated that the leak plugging material 1982 can be formed to be any suitable size in order to effectively plug any holes that may develop in the balloon wall 1930 during use of the catheter system 1900. For example, in certain embodiments, the leak plugging material 1982 can be provided in the form of “corks” or beads that are between approximately one μm and 100 μm in diameter. More particularly, in some such embodiments, the leak plugging material 1982 can be provided in the form of “corks” or beads that are approximately 1 μm, 2 μm, 5 μm, 7 μm, 10 μm, 15 μm, 20 μm, 25 μm, 30 μm, 35 μm, 40 μm, 45 μm, 50 μm, 55 μm, 60 μm, 65 μm, 70 μm, 75 μm, 80 μm, 85 μm, 90 μm, 95 μm, or 100 μm in diameter. Alternatively, the leak plugging material 1982 can be provided in the form of “corks” or beads that are greater than 100 μm or less than one μm in diameter.
Additionally, the leak plugging material 1982 can be formed from any suitable materials. For example, in alternative embodiments, the leak plugging material 1982 can be non-absorbable or bio-absorbable. It is appreciated that bio-absorbable material has the advantage that such leak plugging material 1982 smaller than the hole size that escape the balloon 1904 before being plugged will metabolize within the microvascular before causing blockage that could lead to ischemia. Further, in certain non-exclusive alternative embodiments, the leak plugging material 1982 can be formed from gelatin, collagen, fibrin, polylactic acid, polyglycolic acid, poly(lactic-co-glycolic) acid, and polycaprolactone or other suitable materials used in closure devices.
The catheter 2002, including the catheter shaft 2010, the balloon 2004, and the guidewire lumen 2018, is generally similar in design and operation to what has been described in detail herein above. Thus, such components will not be described in detail again in relation to the embodiment shown in
As above, the balloon 2004 is selectively movable between a deflated configuration suitable for advancing the catheter 2002 through a patient's vasculature, and an inflated configuration suitable for anchoring the catheter 2002 in position relative to the treatment site 106 (illustrated in
However, in this embodiment, the balloon integrity protection system 2042 is somewhat different than in the previous embodiments. In particular, as shown in
It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content and/or context clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content or context clearly dictates otherwise.
It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase “configured” can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like.
The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or otherwise to provide organizational cues. These headings shall not be viewed to limit or characterize the invention(s) set out 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 technology is prior art to any invention(s) in this disclosure. Neither is the “Summary” or “Abstract” to be considered as a characterization of the invention(s) set forth in issued claims.
The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the present detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. As such, 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 herein.
It is understood that although a number of different embodiments of the catheter systems have been illustrated and described herein, one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments, provided that such combination satisfies the intent of the present invention.
While a number of exemplary aspects and embodiments of the catheter systems have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are 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 herein shown.
This application claims priority on U.S. Provisional Application Ser. No. 63/033,929, filed on Jun. 3, 2020. To the extent permitted, the contents of U.S. Provisional Application Ser. No. 63/033,929 are incorporated in their entirety herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20210378743 A1 | Dec 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 63033929 | Jun 2020 | US |
