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WO2025137664A1 - Système de lithotripsie intravasculaire à durabilité, efficacité et variabilité de sortie de pression améliorées - Google Patents

Système de lithotripsie intravasculaire à durabilité, efficacité et variabilité de sortie de pression améliorées Download PDF

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Publication number
WO2025137664A1
WO2025137664A1 PCT/US2024/061620 US2024061620W WO2025137664A1 WO 2025137664 A1 WO2025137664 A1 WO 2025137664A1 US 2024061620 W US2024061620 W US 2024061620W WO 2025137664 A1 WO2025137664 A1 WO 2025137664A1
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WO
WIPO (PCT)
Prior art keywords
ivl
catheter
catheter assembly
balloon
polymer tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/061620
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English (en)
Inventor
Tim HIDANI
Alex Thome
Daniel Schmitt
Kevin Cornelius
Sam GARDNER
Michelle PETERSON
Khama CHAP
Eric Kasen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiovascular Systems Inc
Original Assignee
Cardiovascular Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/US2023/085868 external-priority patent/WO2024138212A1/fr
Priority claimed from US18/991,527 external-priority patent/US20250195094A1/en
Application filed by Cardiovascular Systems Inc filed Critical Cardiovascular Systems Inc
Publication of WO2025137664A1 publication Critical patent/WO2025137664A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/22022—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement using electric discharge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Definitions

  • a frequent objective of such techniques and instruments is the removal of atherosclerotic plaque in a patient’s arteries.
  • Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (i.e., under the endothelium) of a patient’s blood vessels.
  • the intimal layer i.e., under the endothelium
  • atheromas restrict the flow of blood, cause the vessel to be less compliant than normal, and therefore often are referred to as stenotic lesions or stenoses, the blocking material being referred to as stenotic material.
  • Angioplasty is an endovascular procedure to treat by widening narrowed or obstructed arteries or veins, typically to treat arterial atherosclerosis.
  • a collapsed balloon is typically passed through a pre-positioned catheter and over a guide wire into the narrowed occlusion and then inflated to a fixed pressure. The balloon forces expansion of the occlusion within the vessel and the surrounding muscular wall until the occlusion yields from the radial force applied by the expanding balloon, opening up the blood vessel with an inner diameter that is similar to the native vessel in the occlusion area and, thereby, improving blood flow.
  • IVL devices include a voltage pulse generator in operative communication with one or more pairs of electrodes mounted on a catheter and within an inflatable balloon.
  • Intravascular lithotripsy systems, devices and methods have been described in PCT/2022/074607, filed August 5, 2022, and entitled “INTRAVASCULAR LITHOTRIPSY BALLOON SYSTEMS, DEVICES AND METHODS”, the entire contents of which are hereby incorporated by reference.
  • Figure 1 As illustrated in Figure 1, a diagrammatic layout of portions of an exemplary IVL system 12 is provided.
  • the illustrative IVL system 12 comprises a catheter assembly 114 including an elongate body, embodied as a catheter having guidewire 15, and a fluid-filled member 16 configured to contain conductive fluid therein, exemplified by an inflatable balloon, disposed near one end of the body and arranged to receive fluid for inflation to facilitate IVL therapy.
  • a set of dischargeable spaced-apart electrodes 18 are shown arranged within the exemplary balloon 16, at least some of which are spaced apart by a gap 17 from each other to allow formation of a spark or electrical arc between the spaced-apart electrodes 18 when a voltage potential is provided between the electrodes 18.
  • the IVL system embodiments described herein may be used in connection with electrodes that are within a fluid-filled member 16 configured to contain a fluid, e.g., a conductive fluid, therein.
  • the fluid-filled member 16 embodiments may include an inflatable balloon as shown in Figure 1, which may be compliant or non-compliant and serves to contain the fluid such that the spaced-apart electrodes 18 are submerged within the contained fluid.
  • the fluid-filled member 16 may comprise a fillable member that is at least partially rigid and/or not flexible.
  • the fluid-filled member 16 may contain the fluid therein and wherein the spaced-apart electrodes 18 are located or submerged within the contained fluid.
  • the IVL system control embodiments of the present disclosure may be used in connection with electrodes that are not located or surrounded by a fluid-filled or fillable member 16.
  • the IVL system may comprise spaced-apart electrodes 18 that may be continuously or periodically exposed to saline or other fluid and, during the exposure, the IVL system may generate an electrical arc between the spaced-apart electrodes 18.
  • each of the spaced-apart electrodes in Figure 1 is arranged in communication (as suggested by dashed line conductors) with an electric pulse generation system, or voltage pulse generator, 20 to receive high voltage electrical energy for spark generation to create pressure waves for IVL therapy.
  • one electrode may be grounded and the other provided with high voltage from the electric pulse generation system 20, although in some embodiments, any voltage differential may be applied.
  • the electric pulse generation system 20 includes an IVL control system 22 comprising a processor 24 configured for executing instructions stored on memory 26 and communications signals via circuitry 28 for IVL operations according to the processor governance.
  • the processor 24, memory 26, and circuitry 28 are arranged in communication with each other (as suggested via dashed lines) to facilitate disclosed operations.
  • Adjustable energy delivery can increase efficient power application, which can reduce risk to the patient. For example, beginning with a predetermined starting voltage threshold and defining a predetermined upper voltage threshold to form an acceptable voltage window may be proved.
  • the acceptable voltage window may be coupled with series of generated voltage pulses of magnitudes that are confirmed to be within the acceptable voltage window. If, e.g., the magnitudes of the series of generated voltage pulses are below the predetermined upper voltage threshold, then the target voltage may be increased by a predetermined amount and another series of generated voltage pulses is executed.
  • the embodiments of the IVL systems, devices and methods within the present disclosure includes operation for adjusting the total electrical energy provided to the set of electrodes for a given pulse.
  • Patent Number 6,287,272 (ultrasound), the entire contents of which are hereby incorporated by reference.
  • a portion of an exemplary known competitive IVL device is shown in cross-section in Figure 2, viewed in cross-section along a line cutting through an IVL balloon which surrounds, inter alia, a catheter body.
  • the prior art inflation port is in fluid communication with the fill lumen/ passageway.
  • the fill lumen/ passageway of the competitive IVL device of Figure 2 is formed between the inner surface of the catheter body and an outer surface of a sleeve that encompasses wire conductors (terminating at electrodes that are located along the catheter and within the balloon).
  • the wire conductors of the known device are not exposed to the fluid within the fill lumen/passageway. Electrodes that are located within the balloon and electrically connected with the wire conductors are not covered by the encompassing sleeve and, therefore, are exposed to fluid within the balloon.
  • the known competitive device comprises an angioplasty balloon that is adhered at both the proximal end of the balloon and the distal end of the balloon to an outer surface of the catheter body, with the fill lumen/passageway into the balloon’s interior being formed within the catheter body and defined by a space between the sleeve and the inner surface of the catheter body.
  • the competitive known IVL balloon is adhered at its proximal end and its distal end to one structure, that is, the outer surface of the catheter body.
  • the competitive known IVL device of Figure 2 comprises the catheter body, and the guidewire member (which defines the guidewire lumen) both extending through the balloon. Both of these structures continue distally beyond a distal end of the balloon to a distal tip.
  • the distal tip of the known competitive device comprises a stiffness and deformability that can be improved upon to, in turn, improve the device’s ability to translate tortuous vasculature and reduce the potential of damaging the vasculature during translation.
  • a portion of the competitive known IVL device is shown in cross- section in Figure 2, viewed in cross-section along a line cutting through an IVL balloon which surrounds, inter alia, a catheter body.
  • One manual measurement, using a destructive method to cut a section of the balloon to measure, using a calibrated micrometer has shown that one type of a known competitive IVL device has a single wall thickness of about 0.001".
  • Another measurement of a different known competitive IVL device yielded a single wall thickness result of about 0.0013".
  • Figure 3 graphically illustrates the drop in impedance of a current leader across a spark gap defined between two spaced-apart electrodes in an IVL system such as shown in Figure 1 following application of voltage to one of two spaced-apart electrodes as the current leader develops into an electrical arc between the spaced- apart electrodes. This, in turn, causes the power dissipated in the electrical arc to peak sharply while the voltage and current between the electrodes are both relatively high.
  • the current reaches a peak and the voltage drops, both very rapidly, indicating that an electrical arc between the spaced-apart electrodes is present, or has occurred.
  • the peak of the power dissipated in the electrical arc indicates the relatively short time interval during which all the useful work of heating the growing leader into an arc is performed.
  • the graphic illustration of Figure 3 is exemplary of one aspect of an IVL procedure that produces pressure waves. [0018] It would be advantageous to provide an IVL system and/or device that reduces the risk of trauma during translation of the angioplasty balloon to an anatomical location of interest and that reduces the complexity of construction of a lithotripsy system.
  • Known IVL devices also comprise a spark gap between electrode pairs that, when a sufficiently high voltage is applied to a first electrode, facilitates a spark or electrical arc of current from the first electrode across the spark gap to a second electrode in the electrode pair. This process results in loss of material, or erosion, from each of the electrodes in the electrode pair.
  • Known spark gaps are generally arranged axially, i.e., with terminal faces of wire conductors spaced apart from each other and facing each other in an axial spark gap configuration..
  • the electrical arc involves the terminal or distal face of at least one electrode in the electrode pair.
  • the spark gap continues arcing across the spark gap during an IVL procedure with these known devices results in erosion of material from each electrode involved in the electrical arc.
  • Each of these arcs causes the spark gap to slightly increase in size and/or short, with the full procedural set of arcs resulting in an appreciable increase in spark gap size which may lead to unpredictability in generating an electrical arc.
  • 1st and 2nd electrodes may be arranged concentrically, with the spark gap defined in a radial direction, wherein the 1st and 2nd electrodes are not arranged along a common radial or circumferential plane.
  • known IVL devices produce a resultant pressure output, or “shockwave” or “pressure wave” that over a series of electrical arcs, decreases in magnitude as the IVL procedure is executed.
  • the highly variable pressure outputs produced by the known IVL devices can lead to unpredictable, or undesirable, outcomes and perhaps contributes to balloon instability over time due to the variability of the pressure outputs placing stress on the balloon material.
  • known IVL coronary devices are configured to produce a total maximum number of 120 pulses per catheter at a frequency of 1 Hz.
  • Known IVL peripheral device are configured to produce a total maximum number of 300 pulses per catheter at 1 Hz.
  • an IVL device or system that is designed to maintain a desired spark gap distance between spaced-apart electrodes across the execution of a full IVL procedure and produce tightly controlled output pressures having a much tighter data spread from high to low data points, and lower standard deviation as compared to the known IVL devices.
  • Figure 1 illustrates a schematic view of an exemplary IVL device.
  • Figure 2 illustrates a cutaway view of a known IVL device.
  • Figure 3 illustrates a graphic illustration of a typical timing of applied voltage and current during application of voltage and generation of an electrical arc between spaced-apart electrodes.
  • Figure 4 illustrates one embodiment of the present disclosure.
  • Figure 5 illustrates one embodiment of the present disclosure.
  • Figure 6 illustrates a side, cutaway view of a distal portion of an exemplary embodiment of the present disclosure.
  • Figure 7A illustrates a side, cutaway view of an exemplary embodiment of the present disclosure.
  • Figure 7B illustrates a side, cutaway view of an exemplary embodiment of the present disclosure.
  • Figure 8 illustrates a side, cutaway view of a portion of the distal region of an exemplary embodiment of the present disclosure.
  • Figure 9 illustrates a partial cutaway view of a portion of an exemplary embodiment of the present disclosure.
  • Figure 10 illustrates a side, cutaway view of a portion of Figure 6.
  • Figure 11 illustrates a side, cutaway view of the embodiment of Figure 10.
  • Figure 12A illustrates an embodiment of a portion of a system of the present disclosure.
  • Figure 12B1 illustrates an embodiment of a portion of a system of the present disclosure.
  • Figure 12B2 illustrates an expanded view of a portion of a system of the present disclosure.
  • Figure 12B3 illustrates an expanded view of a portion of a system of the present disclosure.
  • Figure 12C illustrates an embodiment of a portion of a system of the present disclosure.
  • Figure 12D illustrates an embodiment of a portion of a system of the present disclosure.
  • Figure 12E illustrates a cross-sectional view of a portion of a system of the present disclosure.
  • Figure 12F illustrates a cross-sectional view of a portion of a system of one embodiment of the present disclosure.
  • Figure 12G illustrates a cross-sectional view of a portion of a system of one embodiment of the present disclosure.
  • Figure 13A illustrates an embodiment of a portion of a system of the present disclosure.
  • Figure 13B illustrates an embodiment of a portion of a system of the present disclosure.
  • Figure 14A illustrates a side, cutaway view of one embodiment of the present disclosure.
  • Figure 14B illustrates a portion of device illustrated in Figure 14A.
  • Figure 15A illustrates one embodiment of the present disclosure.
  • Figure 15B illustrates one embodiment of the present disclosure.
  • Figure 15C illustrates one embodiment of the present disclosure.
  • Figure 15D illustrates one embodiment of the present disclosure.
  • Figure 19A illustrates one embodiment of the present disclosure.
  • Figure 19B illustrates one embodiment of the present disclosure.
  • Figure 20 illustrates a side view of one embodiment of the present disclosure.
  • Figure 21 illustrates a schematic diagram of one embodiment of the present disclosure.
  • Figure 22 illustrates a top cutaway view of one embodiment of the present disclosure.
  • Figure 23 illustrates a block diagram of one embodiment of the present disclosure.
  • Figure 24 illustrates a pressure plot comparing test and known IVL devices.
  • Figure 25 illustrates a force tracking plot comparing tracking force through a tracking fixture for TEST and KNOWN IVL catheters.
  • Figure 26A illustrates an IVL catheter of one embodiment of the present disclosure.
  • some embodiments may comprise a handle that may comprise an EPROM comprising programmed instructions, for example and without limitation, initiating voltage pulses at a predetermined magnitude and frequency and in a predetermined pattern of pulses and magnitudes.
  • the EPROM may be in operative communication and connection with a console comprising a processor for executing programmed instructions, a memory in operative communication with the processor and, in some embodiments, the EPROM, and a display.
  • the hub 118 may allow for over-the-wire guidewire access through a lumen defined within the catheter.
  • the proximal portion 207 of the cylindrical distal section 206 that surrounds, and is sealed or bonded in a watertight engagement against the outer surface of, the elongate member 220 comprises a length of LS, which is shorter than L4. Accordingly, the distal tip 218 extends distally beyond the distal end of the elongate member 220 for a distance to provide an atraumatic tip and to facilitate translation through the vasculature.
  • the inflatable portion 210 of the balloon 200 comprises the unbonded section (length L3) 203, the tapering proximal section 212 and the tapering distal section 214, and the substantially cylindrical section 216 disposed therebetween.
  • the length of the inflatable section is L6 which includes the unbonded section 203 of the proximal cylindrical section of length L3, the proximal tapering section 212 of length L7, the distal tapering section 214 of length L8, and the substantially cylindrical section 216 of length L9, for an overall inflatable section length of L6.
  • the tapering outer member 230 may taper down to a smallest outer diameter OD2 at its distal end that is smaller than outer diameter OD1 which is the effective outer diameter of the proximal cylindrical section 202 as well as the outer diameter of the non-tapering portion 234 of the tapering outer member 230.
  • an inner diameter of the balloon’s cylindrical proximal section 202 may be substantially equivalent to the outer diameter of the tapering outer member at OD1, which is the non-tapering portion 234 of the tapering outer member to which the proximal cylindrical section is watertight bonded or sealed.
  • an inner diameter of the proximal portion 207 of the balloon’s cylindrical distal section 206 that is watertight bonded or sealed to the elongate member 220 may be substantially equivalent to the outer diameter of the elongate member 220 at OD3.
  • the outer diameter of the outer member to which the balloon’s cylindrical proximal section is sealed or bonded may be greater than the outer diameter of the elongate member with outer diameter OD3.
  • the elongate member 220 is received within tapering outer member 230.
  • the balloon 200 is sealed against two distinct structures. On the proximal side, the balloon 200 is sealed against the non-tapering outer surface 234 of the outer member 230 while on the distal side, the balloon 200 is sealed against the outer surface of the elongate member 220.
  • the balloon’s distal tip 218 is preferably flexible and comprises a conduit defined therethrough and that aligns with a conduit defined through the elongate member to allow for, inter alia, guidewire access.
  • the larger proximal side outer diameter OD1 as compared with smaller distal side outer diameter OD3, may produce a tapering angle ⁇ for the tapered proximal section of the balloon that is different from, e.g., smaller than, the tapering angle ⁇ for the tapered distal section of the balloon.
  • tapering angles are measured with reference to the dashed lines of Figure 7A, which are collinear with the non-tapering outer surface of the outer member (tapering angle ⁇ , and the outer surface of the elongate member (tapering angle ⁇ )).
  • the length L7 of the tapered proximal section may be shorter than the length LS of the tapered distal section.
  • the inflatable section 210 may be longitudinally asymmetric with a smaller tapering angle ⁇ at the proximal tapering section 212 than the tapering angle ⁇ at the distal tapering section 214 of the balloon 200, which may help facilitate access into tight lesions.
  • the tapering angles ⁇ and ⁇ may be substantially the same.
  • embodiments of the distal cylindrical section 206 of the balloon 200 comprise a smaller outer diameter at OD3 than the proximal cylindrical section’s 202 outer diameter, which may also facilitate access into tight lesions.
  • the crossing profile of the device distal of the substantially cylindrical section 216 of the balloon 200 is smaller than the crossing profile of the device proximal of the substantially cylindrical section 216 of the balloon 200.
  • the elongate member 220 to which the balloon 200 is sealed on the distal side comprises a polyimide core, which is lined on an inner surface with polytetrafluorethylene, commonly known as PTFE.
  • the outer surface of the polyimide core is lined with 72D Pebax®. That said, other polymers or metals, or combinations or modifications thereof can be used for the elongate member 220.
  • the electrode support members ES (proximal), ES’ (distal) may be stainless steel and are coated with an insulating material such as a polymer or a blend of polymers or other materials, including but not limited to an adhesive, polyimide or other high temperature resistant flowable non-conductive material.
  • Exemplary dimensions for the balloon 200 region may comprise the length of extension of the distal end of the outer member 230 into the inflatable section 210 a distance.
  • An exemplary distance of extension of the outer member’s distal end into the inflatable section is 0.794 mm, but other extension distances are within the scope of the present disclosure.
  • the balloon wall may have a varying nominal thickness therethrough, e.g., longitudinally, circumferentially, or a combination thereof.
  • on the proximal side 204 and the distal side 206 of the balloon may have a thicker wall than a thickness of the wall in the middle portion of the balloon.
  • a “double-wall thickness” means twice a nominal wall thickness and can be measured non-destructively on a folded balloon by observing a thickness of the folded balloon, for example, by radially collapsing a balloon to bring two opposed layers together and measuring the resulting thickness of the two opposed layers.
  • the balloon may be comprised of nylon or similar material. In some embodiments, the balloon material is uncoated, which may allow for more efficient transfer of energy from the pressure waves therethrough. Alternatively, the balloon can be coated with a hydrophilic coating, a drug coating, or any combinations or modifications thereof. In still other configurations, the balloon can be formed of a polymer, polyesters, thermoplastics, polyamides, modifications and combinations thereof.
  • the balloon may be made of a single material or composite layer of materials. Tensile strength may be optimized for durability purposes.
  • the presence of the tapering outer member 230 which adds stiffness to the device, the unbonded section 203 of the balloon 200, the tapering section 232 of the tapering outer member 230 which provides for a smaller crossing profile in a wrapped balloon configuration all function to provide additional pushability and strength in the region of the outer member, and further works to prevent kinking of the wrapped balloon device during advancement through a patient’s vasculature, both of which are highly advantageous.
  • a proximal marker band BP and a distal marker band BD may be provided within the balloon’s inflatable portion 210 and disposed around the elongate member 220 at or near the transition from, respectively, the proximal and distal tapered sections 212, 214 into the substantially cylindrical section 216.
  • a first proximal electrode support member ES is located along the elongate member 220 within the inflatable portion 210 at a position that may be closer to a proximal side of the balloon 200.
  • a single electrode support member ES may be provided as will be discussed further.
  • a second (distal) electrode support member ES’ may be located along the elongate member 220 within the inflatable portion 210 at a position that is spaced distally from the first (proximal) electrode support member ES and closer to the distal side of the balloon 200.
  • the two electrode support members ES and ES’ are operatively and electrically connected by wire conductors W that are in operative electrical communication with the voltage pulse generator 10 as will be discussed further.
  • Figure 9 illustrates a portion of the elongate member 220 and outer member 230 with the balloon 200 removed.
  • the first and second electrode support members ES, ES’ are shown in closer detail with the wire conductors W connected in a series connection.
  • two or more cutouts and the respective spark gaps may be longitudinally aligned.
  • the electrode support members ES and ES’ may be rotated relative to each other such that the respective cutouts and spark gaps are also rotationally spaced from each other around the elongate member 220.
  • a preferred rotational spacing may comprise a 90 degree rotational spacing between spark gaps along the elongate member 220, though other rotational spacings are within the scope of this disclosure.
  • FIGS 10 and 11 illustrate cutaway views of a proximal side of the balloon 200 and catheter structure, with a 1st (proximal) electrode support member ES shown with an associated wire conductor W.
  • the wire conductors leading back to the positive and negative terminals of the voltage pulse generator occupy the fluid conveying pipe.
  • a proximal end region of the exposed wire region 302 is shown as located within the cutout, proximate to, and laterally or radially spaced from, the tab or arcuate region 250A.
  • This configuration provides a pair of spaced-apart electrodes defining a spark gap between a lateral surface, and preferably not the distal end surface, of the exposed wire region 302 (comprising a first electrode in the illustrated spaced-apart pair of electrodes) and the tab or arcuate region 250 (comprising a second electrode in the spaced-apart pair of electrodes).
  • the distal end surface face of the wire conductor 300 may serve as an electrode in the above configuration.
  • the preferred embodiment comprises the lateral surface of the exposed wire conductor and that is located at a distal region of the wire conductor, serving as one of the electrodes in a spaced-apart electrode pair.
  • the illustrated embodiment of Figure 10 comprises the lateral surface of the exposed wire region 302 of the wire conductor as a first electrode, meaning that current flows to this electrode first, then across the spark gap to the second electrode of the spaced-apart pair of electrodes. As will be discussed, this current flow may be reversed in certain embodiments of the spaced-apart electrodes, wherein the metallic region (in the Figure 10, the embodiment is a tab or arcuate region 250A) comprises the first electrode in the spaced-apart electrode pair.
  • the lateral surface of the wire conductor comprises the second electrode in the pair of spaced-apart electrodes and current flows to the first exemplary tab or arcuate region 250A, then across the spark gap to the second electrode comprising the lateral surface of the exposed wire region 302.
  • a preferred embodiment comprises the surface area of a first electrode and of a second electrode of a spaced-apart electrode pair to be substantially equivalent.
  • the surface area of a second electrode in a spaced- apart electrode pair may be larger than the surface area of a first electrode.
  • the surface area of a first electrode in a spaced-apart electrode pair may be larger than the surface area of a second electrode.
  • Figure 12B2 further illustrates the overlapping bonded section 403 with the exemplary stainless steel hypotube 402, which is initially surrounded by a thin layer of an outer wall polymer 420, which is made of exemplary 72D Pebax® polymer which continues distally, providing an outer layer for at least a length of the catheter.
  • the polyimide tube or conduit PC extends in a distal direction away from a distal end portion of the hypotube 402.
  • the exemplary 72D Pebax® polymer 420 extends from the proximal portion of the bonded section 403 to the distal portion of the bonded section 403.
  • the wall polymer 420 being formed of 72D Pebax® polymer, it will be understood that other materials, polymers, etc.
  • Figure 12B3 provides a close-up view of the distal end portion of the hypotube 402 and the transition to the polyimide tube or conduit PC.
  • the exemplary 72D Pebax® polymer 420’ comprises a relatively thin wall in the overlapping bonded section 403.
  • the 72D Pebax® wall thickness may increase distal to the distal end 404 of the hypotube 402. This wall thickness differential and transition allows for a balance to be achieved between a highly desirable small crossing profile in the overlapping bonded section 403 with retention of sufficient columnar strength and resulting pushability for the distal end of the catheter shaft.
  • Figures 12B2 and 12B3 further illustrate the wall thickness transition of the exemplary 72D Pebax® polymer 420’ forming an outer wall for the catheter shaft. Both Figures 12B2 and 12B3 illustrate the hypotube 402 with the polyimide tube or conduit PC extending distally from the distal tip 404 of the hypotube 402, surrounded by the outer wall polymer 420 and 420’.
  • Figure 12B3 provides a close-up view of the distal end 404 of the hypotube 402 and the relatively thin outer wall or layer of polymer 420 surrounding the hypotube 402, followed distally by a relatively thick outer wall of polymer 420’ surrounding the polyimide tube or conduit PC.
  • the thickness of polymer layer 420’ relative to wall thickness of polymer layer 420 may be formulated as follows: In some embodiments, the polymer layer 420’ may be between 10% and 50% thicker than the thickness of polymer layer 420. In some embodiments, the polymer layer 420’ may be between 50% and 60% thicker than the thickness of polymer layer 420.
  • the polymer layer 420’ may be between 60% and 70% thicker than the thickness of polymer layer 420. In some embodiments, the polymer layer 420’ may be greater than 70% thicker than the thickness of polymer layer 420.
  • Figure 12E shows a cross-section of the catheter shaft proximal to the overlapping bonded section 403 with conductors or wires located within a wall of the catheter shaft, such as within a portion of the hypotube or a polymer tube.
  • Figure 12F shows a cross- section of the catheter shaft within the overlapping bonded section 403 and comprising the outer polymer layer 420, such as 72D Pebax® coating in one configuration, surrounding the hypotube which surrounds the polyimide tube or conduit.
  • Wire conductors 300 are also exemplified within the overlapping bonded section 403.
  • the resulting outer diameter within the overlapping bonded section 403 of the present disclosure is less than about 0.044 inches. More preferably, the outer diameter of the overlapping bonded section 403 is less than about 0.041 inches. Still more preferably, the outer diameter of the overlapping bonded section 403 is equal to or less than 0.0405 inches.
  • a known IVL device comprises an overlapping section including a hypotube located along an IVL catheter shaft with an outer diameter of about 0.0435 inches.
  • the significant reduction in outer diameter, and crossing profile, of 0.003 inches in the presently described IVL catheter, as compared with the known catheter device, is primarily driven by the reduced polymer wall thickness in the region of the overlapping bonded section 403 as described above.
  • the result is that the presently described IVL catheter comprises a maximum outer diameter that is significantly less than the maximum outer diameter of the known IVL catheter device.
  • the presently described IVL catheter comprises a maximum crossing profile that is significantly less than the maximum crossing profile of the known IVL catheter device.
  • Some embodiments of the presently disclosed IVL catheter 100 may comprise a polymer wall 420’, e.g., 72D Pebax®, extending distally away from the hypotube’s distal end with a wall thickness of about 0.009 inches beginning with the thickened polymer wall 420’ as shown in Figures 12B1-12F. Some embodiments may comprise the thickened polymer wall 420’ beginning with a thickness of about 0.009 inches and tapering distally to a wall thickness of about 0.0038 inches at a point just proximal to the balloon or enclosure location.
  • Figure 12G illustrates a known IVL catheter that includes an internal, tapered support mandrel or tube to provide pushability to the system.
  • This support mandrel runs from distally from a mid-catheter position at the overlapping section at a distal end of the known device’s hypotube, as discussed above, to the known device’s IVL balloon.
  • This support mandrel floats within the lumen of the known IVL catheter for most of the support mandrel’s length.
  • the proximal portion of the mandrel support is thicker than distal portions, adding stiffness to the overall catheter in the proximal region with reduced stiffness moving in the tapering and distal direction.
  • This cross-sectional image is located at a point that is distal to the overlapping bonded section 403 discussed above and further distal to the distal end of the hypotube 202.
  • the shaft comprises conductive wires located within the shaft, but does not require a support mandrel in contrast with the known IVL catheter of Figure 12.
  • the thickened wall 206’ also provides a uniform kink resistance in all bending or flexing directions.
  • a hypotube 410 is provided, which may comprise a polymer, along a length of the polyimide tube on the proximal side of the RX port 406 for support.
  • known devices typically employ a support wire instead of the hypotube 410, but the inventors found that the polyimide tube with an outer polymer jacket comprising the elongate member 220 that transitions into the hypotube 410 solution provides greater and necessary stiffness and support in this critical region.
  • Figure 14A illustrates a cross-sectional view of the tapering outer member 230, balloon 200, elongate member 220 with 1st and 2nd electrode support members ES, ES’.
  • the insulating material I flows beneath portions of the electrode support member ES and or ES’ to form a connection or adherence between portions of the lower surface of the electrode support member ES and/or ES’ and the outer surface of the elongate member 220, while retaining the desired air or fluid gap 270.
  • the electrode support member ES may be used in the IVL system embodiments described above.
  • the electrode support member ES comprises a body B which may be cylindrical and configured to at least partially surround the elongate member 220 as discussed above. In some embodiments the electrode support members discussed herein may not be fully circumferential as will be discussed further.
  • the embodiment of Figures 15A-D comprises two radially spaced-apart cutouts, a first cutout C1A and a second cutout C2B.
  • Each cutout C1A, C2B comprises opposing longitudinal sides L1, L2 and a proximal end PE and a distal end DE.
  • the body B also comprises a longitudinally arranged slot or channel 260 that extends all the way along the body and configured to receive a portion of an insulated wire conductor.
  • the first cutout C1A comprises a slot or channel 262 extending longitudinally away in a proximal direction from the proximal end PE of the first cutout C1A.
  • the second cutout C2B comprises a slot or channel 264 that extends longitudinally away in a distal direction from the distal end DE of the second cutout C2B.
  • the electrode support member ES comprises a body formed of a conductive material which is covered with an insulating material I as described above. A region along one of the opposing longitudinal sides comprises exposed conductive material, with the insulating material covering removed.
  • the exposed conductive material e.g., metal, is provided along longitudinal sides L2 at 250A and 250B, respectively, for each the first and second cutouts C1A, C2B.
  • Figures 15A-15E provides the exposed conductive material portion as individual arcuate regions 250A, 250B that extend radially into each cutout C1A and C2B, respectively.
  • Each of the exemplary arcuate regions 250A, 250B defines one electrode of a spaced-apart electrode pair.
  • the longitudinal slot or channel 260 running the entire length of the electrode support member body B is provided and is configured to receive insulated portion of one or more wire conductors.
  • Figure 15E illustrates a cross-sectional view through body B showing that the longitudinal slot or channel 262 may comprise angled sides, with a smaller opening at the outermost portion of the slot or channel 262.
  • This angled retention structure may be used to retain wires in slots 260, 262 and/or 264.
  • the slots or channels 260, 262, 264 are provided to maintain a crossing profile of the electrode support members that is, at maximum, the outer diameter of the electrode support member body.
  • the slots or channels 260, 262, 264 function to retain the wire conductors and associated electrode regions in the proper position within the subject electrode support member.
  • Figure 15D provides an “unrolled” flattened view of the exemplary electrode support member body B.
  • the electrode-defining arcuate regions 250A, 250B of exposed conductive material may be substantially centered along the longitudinal side L1 or L2 defining the arcuate regions 250A, 250B.
  • one or both of the arcuate regions 250A, 250B of exposed conductive material may be shifted away from the center of the longitudinal side.
  • the arcuate regions 250A, 250B may be centered along the subject longitudinal side and/or shifted away from the center.
  • one of the arcuate regions, e.g., 250A may be offset longitudinally from the location of the other arcuate regions, e.g., 250B. This allows the locations of the arcuate regions 250A and 250B that are defined by a single electrode support member body B (and the resulting spaced-apart electrode, and defined spark gap locations) to be tuned and, in some embodiments, offset both radially and longitudinally from each other.
  • the exemplary electrode support member ES of Figures 15A-15E may comprise a proximal electrode support member such as shown in, e.g., Figure 6 that is coupled with a more distally spaced-apart electrode support member ES’ which is discussed below in Figures 16A-16D.
  • one of the electrode support members ES may comprise a proximal-most electrode support member and the remaining electrode support members ES may comprise intermediate electrode support members located between a proximal and a distal electrode support member.
  • a distal electrode support member ES’ embodiment is illustrated in Figures 16A-16D. This embodiment may comprise a more distally located exemplary electrode support member ES’, such as shown in Figure 6, when operatively combined with at least one more proximally-spaced apart electrode support member such as ES described above.
  • this embodiment may be used alone, thus providing a single electrode support member ES’ with two radially spaced- apart electrode pairs when fully assembled.
  • the single electrode support member ES’ may comprise a single pair of spaced-apart electrodes, wherein the spaced apart electrodes are in operative electrical communication with a first wire conductor that is in operative electrical communication with a first electrode of the electrode pair and a positive or high side terminal of a voltage pulse generator.
  • a second wire conductor may be in operative electrical communication with a second electrode of the electrode pair and a ground or low side terminal of the voltage pulse generator.
  • the embodiment of Figures 16A-16D also comprises two radially spaced-apart cutouts, a first cutout C1C and a second cutout C2D.
  • Each cutout C1C and C2D defines two opposing longitudinal sides L1, L2 and a proximal end PE and a distal end DE as well as a slot or channel 266, 268 extending in the proximal direction from the proximal end PE of each of the first and second cutouts C1C and C2D.
  • exemplary arcuate regions of exposed conductive material 250C and 250D are defined along one of the longitudinal sides of cutouts C1C and C2D, respectively.
  • the regions of exposed conductive material, e.g., metal, 250C and 250D are each defined along longitudinal side L2 of the respective cutout C1C and C2D.
  • Each arcuate region 250C and 250D forms and defines one electrode of a space-apart pair of electrodes.
  • the location of one or both of the arcuate regions 250C and 250D (and the defined spark gap when the wire conductors are added, and the location of the pressure wave produced by the resultant spaced-apart electrodes) may be longitudinally shifted from the center of the defining longitudinal side(s) as shown with the dashed lines in Figure 16D.
  • FIG. 17A- 17D An exemplary spaced-apart electrode pair is illustrated in Figures 17A- 17D.
  • An exemplary electrode support member which may be either of the embodiments discussed above in Figures 15A-16D, is provided. We will describe the illustrated embodiment as an electrode support member ES as described above in connection with Figures 14A-14D.
  • a first cutout C1A is shown illustrated with a portion of an insulated wire conductor 300A located or received within the slot or channel 262 extending proximally away from the first cutout C1A.
  • a distal-most region 302A of the wire conductor 300A is stripped of insulation, leaving an exposed distal-most region 302A of exposed conductive wire.
  • the lateral surface, as opposed to the distal end face or surface, of the exposed distal most region 302a of the wire conductor 300A forms a spaced-apart electrode pair, with a spark gap defined therebetween.
  • the exposed wire region 302A at the distal end of the wire conductor may be positioned generally over the arcuate region to form an alternative embodiment of a spaced-apart electrode pair.
  • Figures 17B and 17C illustrate an exemplary starting and ending positions for the electrode comprising the exposed wire region 302A relative to the spaced-apart electrode comprising the exemplary arcuate region 250A.
  • Figures 17B and C also illustrate a general direction of the current flow and electrical arc across the spark gap defined by the spaced-apart electrode pairs with distance A representing a starting spark gap length and distance B an ending spark gap length between the lateral face of the exposed wire conductor (exemplary first electrode) and the exposed conductive material of the arcuate region (exemplary second electrode).
  • the electrode comprising the exposed wire region 302A begins to erode and translate, effectively move axially (in the illustrative embodiment proximally) along the arcuate region 250A and engaging successively different (more proximal) regions of the arcuate region 250A in the electrical arcing process.
  • the insulation initially covering the wire conductor 300A burns away, exposing successively more wire conductor and, as in Figure 17C, with an exemplary ending position with a spark gap of distance B.
  • FIG. 17D illustrates a cross-sectional view through an exemplary electrode support member ES described in connection with Figs 15A-15E to show the relative positions and locations of exemplary first electrode comprising the exposed wire region 302A an exemplary second electrode comprising arcuate region 250A to define a first spaced-apart electrode pair.
  • the relative positions and locations are shown for a second spaced- apart electrode pair, circumferentially or radially spaced away from the first spaced-apart electrode pair.
  • the spaced-apart electrodes formed by 302A, 250 A and 302B, 250B may each be located a distance from the outer surface of the elongate member 220, wherein the distance from a spaced apart electrode 302A and 302B to the outer surface of the elongate member 220, and the distance from spaced-apart electrode 250A and 250B to the outer surface of the elongate member 220 are substantially equal.
  • This arrangement provides an air or fluid gap 270 which is discussed further above.
  • FIG. 18A and 18B are similar to the embodiment of Figure 17A and 17B, wherein the arcuate region electrode is replaced with a cutout C1A’ comprising a raised flattened region that comprises exposed metal and functions as an electrode.
  • FIGS. 19A and 19B are alternative embodiments, similar in function with Figures 18A-18B except that the raised flattened region electrode is replaced with an inner surface of the cutout C1A’’ of the electrode support member body B that is stripped of insulation for a length or distance, wherein the region of exposed conductive material functions as an electrode.
  • spark gap shaping and related distance as the erosion of the wire conductor’s exposed wire lateral surface erodes may be tuned to the magnitude of the voltage pulses generated by the voltage pulse generator. In such embodiments, an initial series of voltage pulses at a predetermined magnitude, tuned to ensure that electrical arcs are produced between the spaced-apart electrodes at the known spark gap distance.
  • the spark gap distance may change at a known rate and within one or more of a plurality of series of voltage pulses and associated arcing as the electrical arcing process is executed.
  • the lateral surface of the wire conductor’s exposed wire is engaged in arcing and the exposed wire region, e.g., 302A, begins to translate and traverse over the electrode (exposed metal) surface of the electrode support member.
  • the spark gap distances may be substantially the same for a period of pulses/arcs and/or may change across the executed pulses/arcs.
  • Changing spark gap distances may be correlated with the known spark gap distances relating to the relative positions of the lateral surface of the exposed wire of the wire conductor and the location range of produced electrical arc engagement along the exposed conductive material region of the electrode support member that comprises an electrode.
  • the controller may correlate the required, or desired, voltage pulse magnitude with the known spark gap distances, or distances ranges, for an initial series of voltage pulses and associated electrical arcs and further through to the maximum allowed number of voltage pulses and/or electrical arcs for a specific device.
  • the known spark gap distances over time and produced arcs allows the controller to modify the voltage magnitude as the pulse numbers progress (and the spark gap distances change) in order to ensure (1) that an electrical arc occurs; and/or (2) that the pressure output resulting from the controller-initiated voltage pulse at a predetermined magnitude is within a relatively tight and controlled window.
  • the controller may determine whether sufficient electrical energy was released by an energy storage element to produce an electrical arc.
  • the pairs of spaced-apart spark gaps may be arranged, and wired, in a variety of ways. [0175] Perhaps the simplest arrangement involves the electrode support member ES’ discussed above in connection with Figures 16A-16D.
  • the electrode support member ES’ comprises a first cutout C1C with a first wire conductor 300A received within slot or channel 266 and with a first exposed wire 302A having a lateral face serving as a first electrode and positioned in a spaced-apart location relative to an exemplary exposed metal arcuate region 250C serving as a second electrode in a first spaced-apart electrode pair.
  • the spaced-apart electrodes in all embodiments described herein be located at positions that are substantially the same relative to the outer surface of the elongate member 220.
  • the second (more distal) electrode support member may comprise ES’ as described above and, like ES, comprises two radially spaced- apart cutouts C2C, C2D, each cutout C2C, C2D defining a pair of spaced- apart electrodes with a spark gap therebetween.
  • the current flow in Figure 21 initiates at the voltage generator producing a voltage pulse of sufficient magnitude. The resulting current flows distally along a first wire conductor 300A to reach a first electrode comprising the first wire conductor’s distal region of exposed wire 302A.
  • the proximal end of the exposed tantalum wire comprises a lateral face at 302B functions as the fourth electrode in this system and which is preferably in spaced-apart relation with the third electrode defined by the second arcuate region 250B.
  • a second electrical arc is formed across the spark gap and a pressure wave results.
  • the current flows along the second wire conductor 300B comprising the tantalum bridge wire to a more distally spaced and located electrode support member ES’.
  • FIG. 26A-26B Various tests have been performed on IVL catheters to examine structural characteristics of the IVL catheters related to pushability and/or deliverability through coronary vessels.
  • FIG 26A-26B illustrated in Figure 26A-26B are testing positions 2610-2650 of several working embodiments of an IVL catheter 2600 that were tested on a testing apparatus 2660 according to aspects of the present disclosure.
  • the catheter 2600 can be any of the catheters described herein and described in relation to Figures 1-25.
  • the portion of the IVL catheter 2600, which is to be inserted into or navigate coronary vessels, is an elongated portion (e.g., the elongate member 220 of Figure 6) of the IVL catheter 2600.
  • hypotube 402 can be formed of stainless steel, it is understood that other metals, alloys, polymers, ceramics, composites, combinations or modifications therefore, whether coated or uncoated with a polymer, ceramic or other coating (e.g., to improve lubricity, hydrophobicity or hydrophilicity, or a combination thereof, relative to an uncoated base material), can form the elongate structure of the hypotube 402. [0219] As illustrated, five positions 2610-2650 are selected.
  • the first position 2610 is positioned at a balloon (e.g., the balloon 200 of Figures 6, 7A, and 7B), which is coupled with, e.g., fixedly bonded to, a distal portion of the polymer tube 430 of the IVL catheter 2600.
  • the first position 2610 may be positioned in a region extending from the distal tip of the IVL catheter 2600 to about 1 cm proximal of the balloon.
  • the polymer tube 430 may be tapering out and is not sealed or bonded against any portion of an elongate member (e.g., the elongate member 220 of Figures 6, 7B, 9-11, 12D, 14A, 14B, and 17A).
  • the balloon length can be equal to or greater than 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40 mm, 42 mm, 44 mm, 46 mm, 48 mm, 50 mm, 52 mm, 54 mm, 56 mm, 58 mm, 60 mm, or is in a range between any two of the foregoing, e.g., from a selected first one of the foregoing to a selected second one of the foregoing.
  • a tapering outer member of the balloon which is positioned near the distal tip of the elongate member, provides stiffness.
  • the tapering section of the tapering outer member provides a relatively smaller crossing profile in a wrapped balloon configuration, thereby providing additional pushability and strength in the region of the outer member of the balloon. Further, kinking of the wrapped balloon may be prevented while the distal tip (e.g., the distal tip 218 of Figure 7A) of the polymer tube 430 advances in the coronary vessel.
  • One or more electrode support members ESs may surround the elongate member as illustrated in Figures 6, 7B, 9, 11, 12D, 14A, 14B, and 15A-15D.
  • the ESs may be stainless steel and are coated with an insulating material such as a polymer or a blend of polymers or other materials, including but not limited to an adhesive, polyimide or other high temperature resistant flowable non-conductive material.
  • an insulating material such as a polymer or a blend of polymers or other materials, including but not limited to an adhesive, polyimide or other high temperature resistant flowable non-conductive material.
  • Other metals or alloys can be used for the electrode support members (ES, ES’).
  • the middle portion (e.g., segments 212, 214 in FIG.7A) of the balloon may be pleated and folded around the elongate member and the ESs, thereby increasing the bending stiffness in the middle portion and providing further deliverability and pushability of the balloon portion, which is positioned near the distal tip of the polymer tube 430.
  • Bending stiffness of each portion of the IVL catheter 2600 was assessed at each of the five positions 2610-2650 based on 3-position bending tests, in compliance with ASTM F2606 – 08 standard (approved and published in August 2021).
  • the testing apparatus 2660 has a first support 2662 and a second support 2664, where the catheter 2600 is placed, and an upper strain (or load) applicator 2670, which applies vertical force to the cathether at a position centered between the supports 2662, 2664 from above in the direction of an arrow 2680 and releases the vertical force in a direction opposite to the direction of arrow 2680.
  • the span between the two supports 2662, 2664 may be one inch and a rate of application of the vertical force by the upper strain applicator may be one inch per minute.
  • a maximum deflection may be limited to five millimeters (mm), in certain test configurations.
  • the IVL catheter 2600 Prior to load tests, the IVL catheter 2600 may have been soaked in 37 °C water for at least about 2 hours. It will be understood that the separation of the supports 2662, 2664 can be greater or lesser than one inch, the application of strain force rate can be faster or slower than one inch per minute, maximum deflection may be limited to five mm or can be greater or lesser than five mm, and the IVL catheter 2600 may have been soaked in water at other (e.g., higher or lower) temperatures and for shorter or longer duration than about 2 hours.
  • each testing position 2610-2650 of the catheter 2600 is centered between the two supports 2662, 2664 and the upper strain applicator 2670 applies vertical strain force to a mid-point of the specimen (or segment thereof) under test following the strain force rate (e.g., 1 in/min). The amount of vertical force applied to the specimen under test by the applicator 2670 was measured as the catheter 2600 deformed.
  • test results e.g., vertical displacement of the simply supported segment of the specimen under test as a result of the strain force, or vertical load, applied in a unit of grams (g) to the segment under test
  • the measured force-displacement curves e.g., observed for each specimen at a respective segment
  • the bending stiffness of a segment under test can be estimated by dividing a total force applied by a vertical displacement of the segment under test.
  • the unit of the bending stiffness can be force-per-unit- displacement, e.g., grams-force per millimeter (gf/mm), as used herein.
  • gf/mm grams-force per millimeter
  • ASTM F2606- 08, Section 8.4 accounts for a modest non-linearity in the substantially linear region of the force-displacement curves 2710-3120 shown in Figures 27-31 by imposing an upper threshold value of R 2 , e.g., R 2 ⁇ 0.9.
  • the first position 2610 of the 12 mm balloon may be different from the first position 2610 of the 20 mm balloon with respect to the distal tip (e.g., the distal tip 218) of the IVL catheter 2600.
  • the force-displacement curve 2720 has a relatively shallow slope (about 3 g/mm and 4 g/mm) than the slope (about 6 g/mm) in the region between 1 to 5 mm according to the force-displacement curve 2720. These slopes are calculated for wider ranges. In consideration of smaller ranges, instantaneous slopes at different points may be calculated to be steeper than or shallower than the average slopes in the whole range.
  • a confidence interval may be considered to have a range of slopes with different confidence levels for the whole range.
  • an effective slope across the whole displacement range may be greater than 5 g/mm based on the force-displacement curve 2720 showing results for IVL catheters with the 20 mm balloons (e.g., balloon 200).
  • the average slope in the whole range may be about 8.7 g/mm for IVL catheters with the 12 mm balloons (e.g., balloon 200).
  • the outer portion of the balloons can be surmised to have more bending stiffness than the middle portion of the balloons, as the end portions of the 12 mm balloons are closer to the upper load applicator 2670 than the end portions of the 20 mm balloons.
  • the outer diameter of the center portion of the balloon can be greater than the outer diameter of the corresponding portion of the elongate member 220.
  • the bending stiffness at the first position 2610 may be higher than the bending stiffness at the two end portions of the balloon without the pleated and folded portions.
  • the average slope may be greater than or equal to ⁇ ⁇ 1.96 ⁇ ⁇ ⁇ ⁇ and less than or equal to ⁇ + 1.96 ⁇ ⁇ , where ⁇ is the mean slope observed among a plurality of sample measurements at a given location, ⁇ is the standard deviation observed among the plurality of sample measurements, and n is the number of sample measurements in the plurality of sample measurements (sometimes referred to in the art as a sample size).
  • the average slope may be greater than or equal to ⁇ ⁇ 2.576 less than or equa ⁇ l to ⁇ + 2.576 ⁇ .
  • the average bending stiffness was observed to be about 8.7 g/mm, and the standard deviation was observed to be about 0.83 g/mm with a sample size of 3.
  • the range of the bending stiffness is from 7.76 g/mm to 9.64 g/mm with the 95 % confidence interval. With the 99% confidence interval, the range of the bending stiffness is from 7.47 g/mm to 9.93 g/mm. In a case where the number of tests is increased, the confidence range may be shortened. Further, when the confidence level increased, the confidence interval may be lengthened.
  • the maximum observed bending stiffness was 9.68 g/mm and the minimum observed bending stiffness was 8.10 g/mm based on the actual test results.
  • the average slope of the approximately linear region of the curves, pursuant to Section 8.4 of ASTM-F2606, shown in the drawings may be identified as a bending stiffness indicating a measure of resistance to bending of the IVL catheter 2600.
  • the bending stiffness may depend on the geometrical structure and the materials of the IVL catheter 2600, and thus provides a suitable means of comparing “bendability” or “stiffness” of one device with another device.
  • Figure 28 illustrates force-displacement curves 2810, 2812, and 2814, which are individual test results for three samples of IVL catheters, each having 12 mm balloons (e.g., balloon 200), and force-displacement curve 2820, which is an average slope of three sample measurements of an IVL catheter having 20 mm balloons (e.g., balloon 200). Since the proximal bonding portion (e.g., proximal portion 204) of the balloons is positioned well less than 3 inches from the distal tip, the second position 2620 is proximally located relative to the balloon.
  • proximal bonding portion e.g., proximal portion 204

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Abstract

L'invention concerne un cathéter et un système de ballonnet segmenté pour un système de lithotripsie intravasculaire ayant un logement amélioré pour des configurations incurvées pour empêcher un endommagement du ballonnet pendant la formation de l'arc entre paires d'électrodes. Le cathéter peut comprendre un élément allongé ayant des régions à flexibilité variable où des régions plus rigides sont configurées pour supporter au moins une paire d'électrodes espacées et des régions plus flexibles sont disposées de chaque côté de chaque région plus rigide. Cette configuration permet à l'élément allongé de s'incurver plus facilement dans la région des électrodes, qui sont situées à l'intérieur d'un ballonnet, ou d'un système de ballonnet segmenté. Le ballonnet peut comprendre des segments de ballonnet avec des sections interposées entre chacun des ballonnets segmentés, le diamètre externe d'un segment de ballonnet gonflé étant supérieur au diamètre externe de la section interposée.
PCT/US2024/061620 2023-12-23 2024-12-22 Système de lithotripsie intravasculaire à durabilité, efficacité et variabilité de sortie de pression améliorées Pending WO2025137664A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
USPCT/US2023/085868 2023-12-23
PCT/US2023/085868 WO2024138212A1 (fr) 2022-12-23 2023-12-23 Système de lithographie intravasculaire à durabilité, efficacité et variabilité de sortie de pression améliorées
US202463654375P 2024-05-31 2024-05-31
US63/654,375 2024-05-31
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US18/991,527 US20250195094A1 (en) 2022-12-23 2024-12-21 Intravascular Lithoplasty System With Improved Durability, Efficiency and Pressure Output Variability

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EP0571306A1 (fr) 1992-05-22 1993-11-24 LASER MEDICAL TECHNOLOGY, Inc. Dispositif et procédé pour enlever des dépôts sur les parois de passages
US6287272B1 (en) 1996-09-05 2001-09-11 Pharmasonics, Inc. Balloon catheters having ultrasonically driven interface surfaces and methods for their use
US10201387B2 (en) 2013-03-13 2019-02-12 The Spectranetics Corporation Laser-induced fluid filled balloon catheter
WO2022074607A1 (fr) 2020-10-08 2022-04-14 3M Innovative Properties Company Matériaux hybrides métal-polymère à indice de réfraction élevé
US11337713B2 (en) * 2015-11-18 2022-05-24 Shockwave Medical, Inc. Shock wave electrodes
US20220338890A1 (en) * 2021-02-26 2022-10-27 Fastwave Medical Inc. Intravascular lithotripsy
WO2023079209A1 (fr) 2021-11-08 2023-05-11 Kone Corporation Câble et ascenseur
US20240016544A1 (en) 2022-07-18 2024-01-18 Bolt Medical, Inc. Emitter selection based on radiopaque emitter stations for intravascular lithotripsy device

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0571306A1 (fr) 1992-05-22 1993-11-24 LASER MEDICAL TECHNOLOGY, Inc. Dispositif et procédé pour enlever des dépôts sur les parois de passages
US6287272B1 (en) 1996-09-05 2001-09-11 Pharmasonics, Inc. Balloon catheters having ultrasonically driven interface surfaces and methods for their use
US10201387B2 (en) 2013-03-13 2019-02-12 The Spectranetics Corporation Laser-induced fluid filled balloon catheter
US11337713B2 (en) * 2015-11-18 2022-05-24 Shockwave Medical, Inc. Shock wave electrodes
WO2022074607A1 (fr) 2020-10-08 2022-04-14 3M Innovative Properties Company Matériaux hybrides métal-polymère à indice de réfraction élevé
US20220338890A1 (en) * 2021-02-26 2022-10-27 Fastwave Medical Inc. Intravascular lithotripsy
WO2023079209A1 (fr) 2021-11-08 2023-05-11 Kone Corporation Câble et ascenseur
US20240016544A1 (en) 2022-07-18 2024-01-18 Bolt Medical, Inc. Emitter selection based on radiopaque emitter stations for intravascular lithotripsy device

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