Patent Application
20230338089
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 can be challenging 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, and vascular graft bypass, to name a few. Such interventions may not always be ideal or may require subsequent treatment intravascular lithotripsy to address the lesion.
Angioplasty catheters used to treat calcified arteries can have a common problem with removing air from the balloon during an intravascular lithotripsy balloon procedure. Techniques, such as a pulling vacuum with a manual pump within the catheter prior to media inflation, can be employed to minimize air volume inside the balloon. Consequently, despite this vacuum method, post-media inflation, there can be a small amount of air inside the balloon. The air inside the balloon is problematic for intravascular lithotripsy balloon catheters because it can impede the catheter's ability to generate a pressure wave, therefore reducing energy delivery.
Additionally, gas bubbles can accumulate throughout the intravascular lithotripsy balloon procedure as more energy applications are delivered inside the balloon. The disadvantage of adding a separate irrigation lumen is that it adds additional diameter to the crossing profile of the balloon. The larger the crossing profile, the more difficult it is for the physician to cross severely calcified vessels. Balloons with crossing profiles larger than the stenosed vessel will not be able to track through the lesion without intervention from devices that can create a pathway big enough for the balloon. It can be challenging to generate enough flow through small ports without high pressure and without making the central lumen large and thereby increasing the crossing profile of the balloon. It can also be difficult to (i) manufacture the extrusion at a small size and (ii) create a seal that can withstand high pressure to achieve flow.
The present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve. In various embodiments, the catheter system includes a balloon and an inflation tube. The balloon has a balloon interior. The inflation tube is configured to guide a flow of an inflation fluid into the balloon interior, The inflation tube has an inflation lumen. The inflation tube is movable between (i) an open configuration wherein the inflation lumen has a first cross-sectional area, and (ii) a collapsed configuration wherein the inflation lumen has a second cross-sectional area that is less than the first cross-sectional area.
In various embodiments, the inflation tube is biased toward the collapsed configuration.
In some embodiments, the inflation tube is configured to be moved to the open configuration using fluid pressure.
In certain embodiments, the inflation tube is biased toward the open configuration.
In various embodiments, the inflation tube is at least partially formed from one of a polymer, a plastic, a synthetic material and a natural material.
In some embodiments, the inflation tube includes a tube wall that varies in thickness.
In certain embodiments, the inflation tube is fully collapsible so that the second cross-sectional area of the inflation lumen is approximately equal to zero.
In various embodiments, in the collapsed configuration, a cross-sectional shape of the inflation tube is substantially elliptical.
In some embodiments, in the open configuration, a cross-sectional shape of the inflation tube is substantially circular.
In certain embodiments, the inflation tube includes a tube adhesive so that the inflation tube is adherable to itself when the inflation tube is in the collapsed configuration.
In various embodiments, the inflation tube has a tube length, and the inflation tube is configured to move to the collapsed configuration along at least a portion of the tube length.
In some embodiments, the inflation tube has a tube length, and the inflation tube is thermally formed along at least a portion of the tube length.
In certain embodiments, the inflation tube is at least partially formed from a first polymer and a second polymer that is different than the first polymer. In some embodiments, the first polymer and the second polymer are thermally bonded to one another.
In various embodiments, the inflation tube includes one or more thermal bonds that are configured to fuse extrusions of varying polymers that at least partially form the inflation tube.
In some embodiments, the second cross-sectional area is less than 90% of the first cross-sectional area.
In certain embodiments, the second cross-sectional area is less than 50% of the first cross-sectional area.
In various embodiments, the second cross-sectional area is less than 25% of the first cross-sectional area.
In some embodiments, the catheter system includes (i) an energy source that generates energy, and (ii) an energy guide that guides the energy into the balloon to generate a plasma to create pressure waves within the balloon interior near the treatment site.
In certain embodiments, the energy source includes a laser, and the energy guide includes an optical fiber.
In various embodiments, the energy guide includes an electrode pair including spaced apart electrodes that extend into the balloon interior. In some embodiments, pulses of high voltage from the energy source are applied to the electrodes and form an electrical arc across the electrodes to generate a plasma within the balloon interior.
The present invention is still further directed toward a method for treating a treatment site within or adjacent to a vessel wall or a heart valve comprising the step of providing any of the catheter systems described herein.
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 are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the scope herein is not limited to the particular aspects 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.
As used herein, the terms “intravascular lesion,” “vascular lesion,” and “treatment site” are used interchangeably unless otherwise noted. The intravascular lesions and/or the vascular lesions are sometimes referred to herein simply as “lesions.” Also, as used herein, the terms “focused location” and “focused spot” can be used interchangeably unless otherwise noted and can refer to any location where the light energy is focused to a small diameter than the initial diameter of the energy source.
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. However, it 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
In various embodiments, the catheter 102 is configured to move to a treatment site 106 within or adjacent to a vessel wall 108A of a blood vessel 108 within a body 107 of a patient 109. The treatment site 106 can include one or more vascular lesions 106A, such as calcified vascular lesions, for example. Additionally, or in the alternative, the treatment site 106 can include vascular lesions 106A, such as fibrous vascular lesions. Still alternatively, in some implementations, the catheter 102 can be used at a treatment site 106 within or adjacent to a heart valve within the body 107 of the patient 109.
The catheter 102 can include 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 defines a conduit through which the guidewire 112 extends. 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. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft 110, and the balloon distal end 104D can be coupled to the guidewire lumen 118.
The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a inflation fluid 132 to expand from a deflated state, suitable for advancing the catheter 102 through a patient's vasculature, to an inflated state (as shown in
The balloon 104 suitable for use in the catheter system 100 includes those that can be passed through the vasculature of a patient 109 when in the deflated state. In some embodiments, the balloon 104 is made from silicone. In other embodiments, the balloon 104 can be made from polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAXTM material, nylon, as non-exclusive examples, or any other suitable material.
The balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from less than one millimeter (mm) up to 25 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least 1.5 mm up to 14 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least two mm up to five mm.
In some embodiments, the balloon 104 can have a length ranging from at least three mm to 300 mm. More particularly, in some embodiments, the balloon 104 can have a length ranging from at least eight mm to 200 mm. It is appreciated that a balloon 104 having a relatively longer length can be positioned adjacent to larger treatment sites 106, and, thus, may be used for imparting pressure waves onto and inducing fractures in larger vascular lesions 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further appreciated that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any one given time.
The balloon 104 can be inflated to inflation pressures of between approximately one atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to inflation pressures of from at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to inflation pressures of from at least six atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to inflation pressures of from at least three atm to 20 atm. In yet other embodiments, the balloon 104 can be inflated to inflation pressures of from at least two atm to ten atm.
The inflation fluid 132 can be a liquid or a gas. Some examples of the inflation fluid 132 suitable for use can include, but are not limited to, one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, or any other suitable inflation fluid 132. In some embodiments, the inflation fluid 132 can be used as a base inflation fluid. In some embodiments, the inflation fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 50:50. In other embodiments, the inflation fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 25:75. In still other embodiments, the inflation fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 75:25. However, it is understood that any suitable ratio of saline to contrast medium can be used. The inflation fluid 132 can be tailored on the basis of composition, viscosity, and the like so that the rate of travel of the pressure waves are appropriately manipulated. In certain embodiments, the inflation fluid 132 suitable for use herein is biocompatible. A volume of inflation fluid 132 can be tailored by the chosen energy source 124 and the type of inflation fluid 132 used.
In some embodiments, the contrast agents used in the contrast media can include but are not 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 limited to, agents such as perfluorocarbon dodecafluoropentane (DDFP, C5F12).
The inflation fluids 132 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 inflation fluid 132 can 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 can be water-soluble. In other embodiments, the absorptive agents are not water-soluble. In some embodiments, the absorptive agents used in the inflation fluids 132 can be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least ten nanometers to one millimeter are discussed elsewhere herein.
The catheter shaft 110 of the catheter 102 can be coupled to the one or more energy guides 122A of the energy guide bundle 122 that are in optical and/or electrical communication with the energy source 124. The energy guide(s) 122A can be disposed along the catheter shaft 110 and within the balloon 104. Each of the energy guides 122A can have a guide distal end 122D that is at any suitable longitudinal position relative to a length of the balloon 104. In some embodiments, each energy guide 122A can include an optical fiber, and the energy source 124 can be a laser. Alternatively, the energy guide 122A can include one or more electrodes, and the energy source 124 can include a high voltage generator. The energy source 124 can be in optical and/or electrical communication with the energy guides 122A at the proximal portion 114 of the catheter system 100. More particularly, the energy source 124 can selectively, simultaneously, and/or sequentially be in optical and/or electrical communication with each of the energy guides 122A in any desired combination, order, and/or pattern.
In some embodiments, the catheter shaft 110 can be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which can be disposed at any suitable position about the guidewire lumen 118 and/or the catheter shaft 110. For example, in certain non-exclusive embodiments, two energy 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 energy 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 energy guides 122A can be spaced apart by approximately 90 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110, etc. Still alternatively, multiple energy 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, the energy guides 122A can be disposed either 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 energy guide bundle 122 can include any number of energy guides 122A in optical communication with the energy source 124 at the proximal portion 114, and with the inflation fluid 132 within the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and/or the energy guide bundle 122 can include from one energy guide 122A to five energy guides 122A. In other embodiments, the catheter system 100 and/or the energy guide bundle 122 can include from five energy guides 122A to fifteen energy guides 122A. In yet other embodiments, the catheter system 100 and/or the energy guide bundle 122 can include from ten energy guides 122A to thirty energy guides 122A. Alternatively, in still other embodiments, the catheter system 100 and/or the energy guide bundle 122 can include greater than 30 energy guides 122A.
The energy guide bundle 122 can also include a guide bundler 152 that brings each of the individual energy guides 122A closer together so that the energy guides 122A and/or the energy guide bundle 122 can be in a more compact form as it extends along or inside the catheter 102 into the blood vessel 108 during use of the catheter system 100. In some embodiments, the energy guides 122A leading to the plasma generator 133 can be organized into the energy guide bundle 122, including a linear block with an array of precision holes forming a multi-channel ferrule. In other embodiments, the energy guide bundle 122 can include a mechanical connector array or block connector that organizes singular ferrules into one of (i) a linear array, (ii) a circular pattern, and (iii) a hexagonal pattern. Alternatively, the energy guide bundle 122 can include a mechanical connector array or block connector that organizes singular ferrules into another suitable array or pattern.
The energy guides 122A can have any suitable design for the purposes of generating plasma and/or pressure waves in the inflation fluid 132 within the balloon interior 146. In certain embodiments, the energy guides 122A can include an optical fiber or flexible light pipe. The energy guides 122A can be thin and flexible and can allow light signals to be sent with very little loss of strength. The energy guides 122A 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 energy 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 energy 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 energy guide 122A can guide light energy along its length from a guide proximal end 122P to the guide distal end 122D, having at least one optical window (not shown) that is positioned within the balloon interior 146.
The energy guides 122A can assume many configurations about and/or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guides 122A can run parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guides 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guides 122A can be disposed along a length of an outer diameter of the catheter shaft 110. In yet other embodiments, the energy guides 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.
The energy guides 122A can also 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 energy 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 to more effectively and precisely impart pressure waves for purposes of disrupting the vascular lesions 106A at the treatment site 106.
In certain embodiments, the energy guides 122A can include one or more photoacoustic transducers 153. Each photoacoustic transducer 153 can be in optical communication with the energy guide 122A within which it is disposed. In some embodiments, the photoacoustic transducers 153 can be in optical communication with the guide distal end 122D of the energy guide 122A. Additionally, in such embodiments, the photoacoustic transducers 153 can have a shape that corresponds with and/or conforms to the guide distal end 122D of the energy guide 122A. Alternatively, no photoacoustic transducers 153 may be included.
The photoacoustic transducer 153 is configured to convert light energy into an acoustic wave at or near the guide distal end 122D of the energy guide 122A. The direction of the acoustic wave can be tailored by changing an angle of the guide distal end 122D of the energy guide 122A.
In certain embodiments, the photoacoustic transducers 153 disposed at the guide distal end 122D of the energy guide 122A can assume the same shape as the guide distal end 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the photoacoustic transducer 153 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. The energy guide 122A can further include additional photoacoustic transducers 153 disposed along one or more side surfaces of the length of the energy guide 122A.
In some embodiments, the energy guides 122A can further include one or more diverting features or “diverters” (not shown in
Examples of the diverting features suitable for use include a reflecting element, a refracting element, and a fiber diffuser. The diverting features suitable for focusing light energy away from the tip of the energy guides 122A 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 energy is diverted within the energy guide 122A to one or more of a plasma generator 133 and the photoacoustic transducer 153 that is in optical communication with a side surface of the energy guide 122A. As noted, the photoacoustic transducer 153 then converts light energy into an acoustic wave that extends away from the side surface of the energy guide 122A.
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 energy guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as illustrated in
The energy source 124 can be selectively and/or alternatively coupled in optical communication with each of the energy guides 122A, i.e., to the guide proximal end 122P of each of the energy guides 122A, in the energy guide bundle 122 so that the guide proximal end 122P is electrically and/or optically coupled to the energy source 124. In particular, the energy source 124 can be configured to generate energy (such as light energy or electrical energy, in certain embodiments) in the form of a source beam 124A, such as a pulsed source beam, that can be selectively and/or alternatively directed to and received by each of the energy guides 122A in the energy guide bundle 122 as an individual guide beam 124B. In certain embodiments, the energy emitted by the energy source 124, such as the source beam 124A and the individual guide beam 124B, can be concentrated to transmit through a long, narrow medium (such as the energy guides 122A) to bring it from the energy source 124 to the plasma generator 133 so that the plasma generator 133 can generate highly localized mechanical effects to treat localized lesions (e.g., the treatment site 106). Various embodiments of the catheter system 100 described herein have improved efficacy for use in narrow human anatomy such as blood vessels 108.
Alternatively, the catheter system 100 can include more than one energy source 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate energy source 124 for each energy guide 122A in the energy guide bundle 122. The energy source 124 can be operated at low energies. In other embodiments, the energy source 124 can be electrical, such as a high-voltage pulse generator.
The energy source 124 can have any suitable design. In certain embodiments, the energy source 124 can be configured to provide sub-millisecond pulses of light energy from the energy source 124 that are focused onto a small spot in order to couple it into the guide proximal end 122P of the energy guide 122A. Such pulses of light energy are then directed and/or guided along the energy guides 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the inflation fluid 132 within the balloon interior 146 of the balloon 104, such as via the plasma generator 133 that can be located at the guide distal end 122D of the energy guide 122A. By locating the plasma generator 133 at the guide distal end 122D, the plasma generator 133 can be routed through torturous human anatomy, such as a constricted artery, for placement adjacent to the treatment site 106. In some embodiments, the plasma generator 133 can be at least partially formed by a metal. In various embodiments, the plasma generator 133 can be configured to be immersed in a liquid (e.g., the inflation fluid 132) that converts the plasma into a mechanical acoustic bubble and transports this energy to the treatment site 106.
In particular, the light emitted at the guide distal end 122D of the energy guide 122A energizes the plasma generator 133 to form the plasma within the inflation fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation and imparts pressure waves upon the treatment site 106. An exemplary plasma-induced bubble 134 is illustrated in
In various non-exclusive alternative embodiments, sub-millisecond pulses of light energy from the energy source 124 can be delivered to the treatment site 106 at a frequency of between approximately one hertz (Hz) and 5000 Hz, between approximately 30 Hz and 1000 Hz, between approximately ten Hz and 100 Hz, or between approximately one Hz and 30 Hz. Alternatively, the sub-millisecond pulses of light energy can be delivered to the treatment site 106 at a frequency that can be greater than 5000 Hz or less than one Hz or any other suitable range of frequencies.
It is appreciated that although the energy source 124 can be utilized to provide pulses of light energy, the energy source 124 can still be described as providing a single source beam 124A, i.e., a single pulsed source beam, or another suitable type of energy source such as a high voltage pulse generator.
Some energy sources 124 suitable for use can include various types of energy sources, including lasers, seed sources, and lamps. For example, in certain non-exclusive embodiments, the energy source 124 can be an infrared laser that emits light energy in the form of pulses of infrared light. Alternatively, as noted above, the energy sources 124, as referred to herein, can include any other suitable type of energy source.
Suitable lasers can include short pulse lasers on the sub-millisecond timescale. In some embodiments, the energy 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 inflation fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse widths can include those falling within a range, including at least ten ns to 3000 ns, at least 20 ns to 100 ns, or at least one ns to 500 ns. Alternatively, any other suitable pulse width range can be used.
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 energy sources 124 suitable for use in the catheter system 100 can include those capable of producing light at wavelengths of from at least 750 nm to 2000 nm. In other embodiments, the energy 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 energy 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. In still further embodiments, the energy source 124 can include SLEDs that have bandwidths ranging from 13.25 GHz to 18.25 GHz at 1064 nm.
The catheter system 100 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 energy source 124, the absorbing material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate pressure waves having maximum pressures in the range of at least approximately two MPa to 50 MPa, at least approximately two MPa to 30 MPa, or at least approximately 15 MPa to 25 MPa.
The pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least approximately 0.1 millimeters (mm) to greater than approximately 25 mm, extending radially from the energy guides 122A when the catheter 102 is placed at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least approximately ten mm to 20 mm, at least approximately one mm to ten mm, at least approximately 1.5 mm to four mm, or at least approximately 0.1 mm to ten mm extending radially from the energy 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 another suitable distance that is different than the foregoing ranges. In some embodiments, the pressure waves can be imparted upon the treatment site 106 within a range of at least approximately two MPa to 30 MPa at a distance from at least approximately 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 approximately two MPa to 25 MPa at a distance from at least approximately 0.1 mm to ten mm. Still alternatively, other suitable pressure ranges and distances can be used.
The power source 125 is electrically coupled to and is configured to provide the necessary power to one or more of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 129. The power source 125 can have any suitable design for such purposes.
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 the operation of each of the energy sources 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 energy source 124, and the GUI 127. For example, the system controller 126 can control the energy source 124 for generating pulses of light energy as desired and/or at any desired firing rate.
The system controller 126 can further be 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, the inflation of the balloon 104 with the inflation 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 the 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 129.
In some embodiments, the multiplexer 128 can include a two-channel splitter design. The guide bundle 122 can include a manual positioning mechanism that is mounted on an optical breadboard and/or platen. This design enables linear positional adjustment and array tilting by rotating about a Channel 1 energy guide 122A axis (not shown in
As shown in
The handle assembly 129 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 129 can vary to suit the design requirements of the catheter system 100. In the embodiment illustrated in
In one embodiment, the circuitry 155 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In an alternative embodiment, the circuitry 155 can be omitted or can be included within the system controller 126 or otherwise within the system console 123, which in various embodiments can be positioned outside of the handle assembly 129.
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 one or more energy guides 122A of the energy guide bundle 122, the guidewire 112, and/or an inflation conduit 140 that is coupled in fluid communication with the fluid pump 138.
The fluid pump 138 is configured to inflate the balloon 104 with the inflation fluid 132 as needed.
The inflation tube 219 can vary depending on the design requirements of the catheter system 200, the balloon 204, the catheter shaft 210, the guidewire 212, the guidewire lumen 218, and/or the energy guides 222A. It is understood that the inflation tube 219 can include additional components, systems, subsystems, and elements other than those specifically shown and/or described herein. Additionally, or alternatively, the inflation tube 219 can omit one or more of the components, systems, subsystems, and elements that are specifically shown and/or described herein. In some embodiments, various components of the inflation tube 219 can be positioned differently than what is specifically illustrated in the figures.
In various embodiments, the inflation tube 219 can be at least partially formed from a synthetic material, a natural material, a plastic, a polymer, a thermal material, and/or a composite material. Suitable polymers can include Pebax, Urethane, and/or Nylon, or any other suitable polymer. In various embodiments, the inflation tube 219 can be formed to have a reduced form factor in a collapsed configuration (e.g., as shown in
As illustrated in
In certain embodiments, the inflation tube 319 can include a tube adhesive 319B that is configured to enable the inflation tube 319 and/or the tube wall 319W to adhere to itself. The tube adhesive 319B can vary depending on the design requirements of the inflation tube 319 and/or the tube wall 319W, but can include any suitable adhesive material that can adhere one portion of the inflation tube 319 to another portion of the inflation tube 319. The tube adhesive 319B is simplified in
In some embodiments, the adherence of the inflation tube 319 relative to itself can be overcome when pressure inside the inflation tube 319 reaches a predetermined threshold level. In one non-exclusive embodiment, a fluid pressure of the inflation fluid 132 (illustrated in
The inflation tube 319 can also be movable between the first configuration 319F and second configuration 319S by other external and/or internal forces. In other embodiments, the inflation tube 319 can be configured so that the inflation lumen 319A at least partially collapses and/or at least partially expands. As non-limiting, non-exclusive examples, external forces that can be used to move the inflation tube 319 between the first configuration 319F and the second configuration 319S can include pressure forces, thermal forces, and/or electrically-induced forces.
In certain embodiments, as non-limiting, non-exclusive examples, internal forces that can be used to move the inflation tube 319 between the first configuration 319F and the second configuration 319S can include pressure forces, thermal forces, and/or electrically-induced forces. In some embodiments, the inflation tube 319 can be moved to the first configuration 319F using one of an inflator (e.g., an inflation hub 458, illustrated in
In various non-exclusive alternative embodiments, the second cross-sectional area can be less than: 90%, 75%, 50%, 40%, 30%, 25%, 20%, 15%, 10% or 5% of the first cross-sectional area.
The inflation hub 458 can control the inflation of the balloon 404, a guidewire lumen 218 (illustrated in
The inflation hub 458 can vary depending on the design requirements of the catheter system 400, the balloon 404, the catheter shaft 410, the guidewire lumen 218, the inflation tube 319, and/or the fluid pump 438. It is understood that the inflation hub 458 can include additional components, systems, subsystems, and elements other than those specifically shown and/or described herein. Additionally, or alternatively, the inflation hub 458 can omit one or more of the components, systems, subsystems, and elements that are specifically shown and/or described herein. In some embodiments, various components of the inflation hub 458 can be positioned differently than what is specifically illustrated in the figures.
While two fluid pumps 438 and two inflation hubs 458 are illustrated in
The first inflation guide 560 can receive inflation from the fluid pump 538 and guide the inflation fluid 132 (illustrated in
The second inflation guide 562 can receive inflation from the fluid pump 538 and guide the inflation toward the guidewire lumen 518 and/or the inflation hub 558. In other embodiments, the first inflation guide 560 can receive fluid from the fluid pump 538 and guide the fluid via the inflation tube 519. The first inflation guide 560 and the second inflation guide 562 can vary depending on their design requirements and/or the design requirements of the catheter system 500.
The inflation director 564 can direct inflation from the fluid pump 538 toward the first inflation guide 560 and/or the second inflation guide 562. The inflation director 564 can control the flow of liquids, gases, and/or inflation through the catheter system 500. The inflation director 564 can also be configured to reduce and/or prevent the flow of liquids, gases, and/or inflation through the catheter system 500. The inflation director 564 can vary depending on its design requirements and/or the design requirements of the catheter system 500. The inflation director 564 can include a directional valve and/or a three-way stopcock valve.
The inflow 668 can guide the flow of inflation, fluids, and/or gases from the circulatory pump 672 to the inflation hub 658. The inflation hub 658 can control the inflation and/or deflation of the guidewire lumen 518 (illustrated in
Following deflation, the outflow 670 can guide the flow of inflation, fluids, and/or gases toward the check valve 676 in one direction (e.g., in the closed loop pump illustrated in
The present invention is also directed toward methods for treating a treatment site within or adjacent to a vessel wall or heart valve, with such methods utilizing the devices disclosed herein.
Lasers
The lasers suitable for use herein can include various types of lasers, including lasers and lamps. Suitable lasers can include short pulse lasers on the sub-millisecond timescale. In some embodiments, the laser 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 inflation fluid of the catheters illustrated and/or described herein. In various embodiments, the pulse widths can include those falling within a range including from at least 10 ns to 200 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 1 ns to 5000 ns.
Exemplary nanosecond lasers can include those within the UV to IR spectrum, spanning wavelengths of about 10 nanometers to 1 millimeter. In some embodiments, the lasers suitable for use in the catheter systems herein can include those capable of producing light at wavelengths of from at least 750 nm to 2000 nm. In some embodiments, the lasers can include those capable of producing light at wavelengths of from at least 700 nm to 3000 nm. In some embodiments, the lasers can include those capable of producing light at wavelengths of from at least 100 nm to 10 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 some embodiments, the laser can include a neodymium:yttrium-aluminum-garnet (Nd:YAG), holmium:yttrium-aluminum-garnet (Ho:YAG), erbium:yttrium-aluminum-garnet (Er:YAG), excimer laser, helium-neon laser, carbon dioxide laser, as well as doped, pulsed, fiber lasers.
Pressure Waves
The catheters illustrated and/or described herein can generate pressure waves having maximum pressures in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter will depend on the laser, the absorbing material, the bubble expansion, the propagation medium, the balloon material, and other factors. In some embodiments, the catheters illustrated and/or described herein can generate pressure waves having maximum pressures in the range of at least 2 MPa to 50 MPa. In other embodiments, the catheters illustrated and/or described herein can generate pressure waves having maximum pressures in the range of at least 2 MPa to 30 MPa. In yet other embodiments, the catheters illustrated and/or described herein can generate pressure waves having maximum pressures in the range of at least 15 MPa to 25 MPa. In some embodiments, the catheters illustrated and/or described herein can generate pressure waves having peak pressures of greater than or equal to 1 MPa, 2 MPa, 3 MPa, 4 MPa, 5 MPa, 6 MPa, 7 MPa, 8 MPa, 9 MPa, 10 MPa, 11 MPa, 12 MPa, 13 MPa, 14 MPa, 15 MPa, 16 MPa, 17 MPa, 18 MPa, 19 MPa, 20 MPa, 21 MPa, 22 MPa, 23 MPa, 24 MPa, or 25 MPa, 26 MPa, 27 MPa, 28 MPa, 29 MPa, 30 MPa, 31 MPa, 32 MPa, 33 MPa, 34 MPa, 35 MPa, 36 MPa, 37 MPa, 38 MPa, 39 MPa, 40 MPa, 41 MPa, 42 MPa, 43 MPa, 44 MPa, 45 MPa, 46 MPa, 47 MPa, 48 MPa, 49 MPa, or 50 MPa. It is appreciated that the catheters illustrated and/or described herein can generate pressure waves having operating pressures or maximum pressures that can fall within a range, wherein any of the foregoing numbers can serve as the lower or upper bound of the range, provided that the lower bound of the range is a value less than the upper bound of the range.
Therapeutic treatment can act via a fatigue mechanism or a brute force mechanism. Pressures between the extreme ends of these two ranges may act upon a treatment site using a combination of a fatigue mechanism and a brute force mechanism. For a fatigue mechanism, operating pressures would be about at least 0.5 MPa to 2 MPa, or about 1 MPa. For a brute force mechanism, operating pressures would be about at least 20 MPa to 30 MPa, or about 25 MPa.
The pressure waves described herein can be imparted upon the treatment site from a distance within a range from at least 0.01 millimeters (mm) to 25 mm, extending radially from a longitudinal axis of a catheter placed at a treatment site. In some embodiments, the pressure waves can be imparted upon the treatment site from a distance within a range from at least 1 mm to 20 mm, extending radially from a longitudinal axis of a catheter placed at a treatment site. In other embodiments, the pressure waves can be imparted upon the treatment site from a distance within a range from at least 0.1 mm to 10 mm, extending radially from a longitudinal axis of a catheter placed at a treatment site. In yet other embodiments, the pressure waves can be imparted upon the treatment site from a distance within a range from at least 1.5 mm to 4 mm, extending radially from a longitudinal axis of a catheter placed at a treatment site. In some embodiments, the pressure waves can be imparted upon the treatment site from a range of at least 2 MPa to 30 MPa at a distance from 0.1 mm to 10 mm. In some embodiments, the pressure waves can be imparted upon the treatment site from a range of at least 2 MPa to 25 MPa at a distance from 0.1 mm to 10 mm. In some embodiments, the pressure waves can be imparted upon the treatment site from a distance that can be greater than or equal to 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, or 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm, or can be an amount falling within a range between, or outside the range of any of the foregoing.
By shaping the temporal form of the optical pulse to have a fast rise time and minimal overshoot (in some embodiments, approaching a square wave), the efficiency for generating the pressure wave can be improved, and the amount of energy that can be delivered in a given time interval can be increased while decreasing the peak laser intensity to remain below the damage threshold of the optical fiber.
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.
As used herein, the recitation of numerical ranges by endpoints shall include all numbers subsumed within that range, inclusive (e.g., 2 to 8 includes 2, 2.1, 2.8, 5.3, 7, 8, etc.).
It is recognized that the figures shown and described are not necessarily drawn to scale, and that they are provided for ease of reference and understanding, and for relative positioning of the structures.
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 following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. 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 is related to and claims priority on U.S. Provisional Patent Application Ser. No. 63/334,553 filed on Apr. 25, 2022, and entitled “ CATHETER INFLATION TUBE FOR USE IN INTRAVASCULAR LITHOTRIPSY.” To the extent permissible, the contents of U.S. Provisional Application Ser. No. 63/334,553 are incorporated in its entirety herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63334553 | Apr 2022 | US |
