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WO2024151291A1 - Cathéter de lithotritie intravasculaire - Google Patents

Cathéter de lithotritie intravasculaire Download PDF

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Publication number
WO2024151291A1
WO2024151291A1 PCT/US2023/031907 US2023031907W WO2024151291A1 WO 2024151291 A1 WO2024151291 A1 WO 2024151291A1 US 2023031907 W US2023031907 W US 2023031907W WO 2024151291 A1 WO2024151291 A1 WO 2024151291A1
Authority
WO
WIPO (PCT)
Prior art keywords
cavitation
tube
electrode
medical device
distal
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.)
Ceased
Application number
PCT/US2023/031907
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English (en)
Inventor
Bradley Beach
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.)
Covellus LLC
Original Assignee
Covellus LLC
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 US18/095,992 external-priority patent/US20230218309A1/en
Priority claimed from US18/144,208 external-priority patent/US20230270459A1/en
Application filed by Covellus LLC filed Critical Covellus LLC
Publication of WO2024151291A1 publication Critical patent/WO2024151291A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A61B2017/00477—Coupling
    • 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
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • 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
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • A61B2017/22008—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing used or promoted
    • 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
    • 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

Definitions

  • the present disclosure relates generally to a design of a medical device for use in the body, and more specifically to a catheter, such as an intravascular lithotripsy catheter.
  • Catheter type devices are typically long tubular structures with an inner lumen suitable for a guidewire used to navigate the vasculature, inject contrast or therapeutic materials, aspirate thrombus, or provide a means to deliver other devices or therapies to a target site within the vasculature or other body lumen.
  • Catheter type devices are typically inserted through a small opening in the skin or another opening under visual guidance and tracked to the target location within the body.
  • Catheters for minimally invasive procedures are typically one-piece, unitary constructions combining structural, therapeutic and diagnostic elements at the distal end of the catheter.
  • U.S. Patent Application Publication No. 2007/0244440 discloses a medical device including a catheter with an expandable tip for use with at least two different sizes of wire guides.
  • the catheter includes a wire guide lumen sized to receive a first wire guide of a first diameter.
  • the catheter may also include a tip lumen that extends in a distal direction from a first opening in communication with the wire guide lumen to a second opening The first opening is sized to receive the first wire guide, and the second opening is sized to receive a second wire guide of a smaller diameter than the first wire guide.
  • the catheter also includes one or more longitudinal expansion features capable of radially expanding the tip lumen to receive a wire guide of a diameter up to the first diameter through the second opening.
  • U.S. Patent No. 8, 100,884 discloses an adapter assembly for connecting a catheter assembly to a tunneler having a generally tubular body having a first end, a second end and a longitudinal axis extending there through between the first end and the second end.
  • the first end of the adapter is constructed to engage the proximal end of a trocar.
  • the second end of the adapter is constructed to releasably engage at least one catheter lumen.
  • a slider is disposed about the adapter and is longitudinally slidable along the adapter. When the slider is slid towards the second end of the adapter, the slider engages a plurality of legs on the adapter and biases the plurality of legs toward each other and the longitudinal axis of the adapter.
  • U.S. Patent No. 8,523,840 discloses coupler assemblies to be used with a catheter to connect a proximal end of the catheter to extracorporeal medical equipment.
  • An exemplary coupler assembly includes a spherical linkage coupler for a catheter.
  • the coupler comprises a first cylinder portion for connecting to a structure, and a second cylinder portion for connecting to a distal end of a body of the catheter.
  • the coupler also comprises a spherical linkage including at least two link arms. Each of the two link arms are connected on one end to the first cylinder portion and on the other end to the second cylinder portion.
  • the two link arms connect a portion of the structure to the distal end of the catheter and enable the structure to move relative to the distal end of the catheter in response to an external force exerted on the structure.
  • U.S. Patent Nos. 9,282,991; 9,808,276; 7,976,557; and U.S. Publication No. 2006/0259005 describe variations of a method of delivering a therapeutic agent, such as a drug, using a cutting balloon wherein the cutting or scoring members may comprise the therapeutic agent coated thereon.
  • the cutting or scoring members are integral with the construction of the balloon and catheter system itself.
  • connection system to connect catheter tubes together to form a secure and leak resistant connection.
  • connection system includes a threaded connector inserted into an end of a catheter lumen where an inner portion of the catheter lumen is elastically compliant to conform to the threaded structure of the connector.
  • U.S. Patent No. 8,956,371 describes a shockwave balloon catheter system that uses shockwaves generated inside the inflatable balloon of an angioplasty balloon catheter to aid in treating vascular lesions blocking blood vessels.
  • the shockwave can aid in breaking up calcium deposits in these vascular lesions.
  • Similar shockwave technology has been used in lithotripter medical devices to help break up kidney stones in the body, as described in U.S. Patent No. 5,047,685, for example.
  • an improved adapter and modular system designed with features that expand, augment, or modify the configuration or intended use of a medical device or parent module, such as by providing lithotripsy functionality.
  • the adapter including geometry, mechanical and/or thermal properties to expeditiously attach to the medical device, such as a catheter.
  • a medical device catheter comprises a cavitation bubble chamber configured to contain a cavitation solution, and at least two electrodes positioned within the cavitation bubble chamber to be in contact with the cavitation solution and to form an electrode gap.
  • a proximal end of the medical device catheter is adapted to remain outside the body of the patient during use of the catheter, and a first lumen is in fluid communication with the cavitation bubble chamber and the proximal end, configured to deliver the cavitation solution from the proximal end of the medical device catheter to the cavitation bubble chamber.
  • the at least two electrodes are configured to generate sparking or arcs across the electrodes which creates a shockwave and cavitation bubbles when powered by a high voltage pulse generator.
  • a medical device catheter comprises a first tube comprising a first cavitation solution lumen having a distal opening; and a second tube housing the first tube and comprising a cavitation bubble chamber, a second cavitation solution lumen in fluid communication with the first cavitation solution lumen through the distal opening, and a distal plug at a distal end of the cavitation bubble chamber to create a distal boundary of the cavitation bubble chamber.
  • a proximal rapid exchange guidewire exit is positioned distal to the distal boundary of the cavitation bubble chamber and in communication with a guidewire lumen; and a first powered electrode extends through the first tube and the first cavitation solution lumen and cavitation bubble chamber and into the distal plug beyond the distal boundary of the cavitation bubble chamber.
  • FIG. l is a schematic, perspective, view of an adapter according to the present disclosure.
  • FIG. 2 is an enlarged detailed view of FIG. 1, showing part of a distal portion of the adapter, the attachment mechanism, and other features.
  • FIG. 3 is an enlarged detailed view of FIG. 1, showing a proximal end of the adapter, including the electrical connector.
  • FIG. 4 is a partial schematic, transverse, cross-sectional view CS1 of the adapter of FIG.
  • FIG. 5 is a partial schematic, transverse, cross-sectional view CS2 of the adapter of FIG. 1.
  • FIG. 6A is a partial schematic, perspective view of a balloon catheter parent before an adapter is attached to the distal end of the balloon catheter parent, and with the inflatable balloon represented as inflated for the purposes of illustration.
  • FIG. 6B is a partial schematic, perspective view of an adapter according to the present disclosure, attached to the distal end of a balloon catheter, and with the inflatable balloon represented as inflated for the purposes of illustration.
  • FIG. 7 is a schematic, perspective view of an adapter according to the present disclosure, attached to the distal end of a balloon catheter, and with a proximal electrical modular interface attached at the proximal end, forming an electrical modular catheter system.
  • the balloon is represented as inflated for the purposes of illustration.
  • FIG. 8 is a schematic, perspective view of an adapter according to the present disclosure.
  • FIG. 9 is an enlarged detailed view of FIG. 8, showing part of a distal portion of the adapter, the attachment mechanism, and other features.
  • FIG. 10 is an enlarged detailed view of FIG. 8, showing the internal features and elements of a distal portion of the adapter.
  • FIG. 11 is a partial schematic, longitudinal view of an adapter according to the present disclosure. Break line symbols are utilized to reduce the size of the drawing for clarity.
  • FIG. 12 is a partial schematic, transverse, cross-sectional view CS3 of the adapter of FIG. 11.
  • FIG. 13 is a partial schematic, transverse, cross-sectional view CS4 of the adapter of FIG. 11.
  • FIG. 14 is a partial schematic, transverse, cross-sectional view CS5 of the adapter of FIG. 11.
  • FIG. 15 is an enlarged detailed view of FIG. 8, showing the internal features and elements of a distal portion of the adapter.
  • FIG. 16 is a schematic, perspective view of an adapter according to an embodiment of the present disclosure.
  • FIG. 17 is an enlarged detailed view of FIG. 16, showing part of a distal portion of the adapter, the attachment mechanism, and other features.
  • FIG. 18 is a partial schematic, perspective view of an adapter according to the present disclosure, attached to the distal end of a balloon catheter. The balloon is represented as inflated for the purposes of illustration.
  • FIG. 19 is a partial schematic, longitudinal view of an adapter according to the present disclosure. Break line symbols are utilized to reduce the size of the drawing for clarity.
  • FIG. 20 is a partial schematic, transverse, cross-sectional view CS6 of the adapter of FIG. 19.
  • FIG. 21 is a partial schematic, transverse, cross-sectional view CS7 of the adapter of FIG. 19.
  • FIG. 22 is an example of a wiring schematic for use with an adapter according to the present disclosure.
  • FIG. 23 is an example of another wiring schematic for use with an adapter according to the present disclosure.
  • FIG. 24 is an alternate electrode configuration according to the present disclosure.
  • FIG. 25 is a partial schematic, transverse, cross-sectional view CS8 of the adapter of FIG. 24.
  • FIG. 26 is a partial schematic, perspective view of an adapter according to the present disclosure.
  • FIG. 27 is a partial schematic longitudinal view with partial cutaway cross-sections of an alternate electrode configuration according to the present disclosure.
  • FIG. 28 is a partial schematic longitudinal view with partial cutaway cross-sections of an alternate electrode configuration according to the present disclosure.
  • FIG. 29 is a schematic, perspective view of a medical device balloon catheter according to the present disclosure.
  • FIG. 30 is an enlarged detailed view of FIG. 29, showing part of a distal portion of the catheter.
  • FIG. 31 is a partial schematic, longitudinal cross-sectional view of the distal end of a medical device balloon catheter according to the present disclosure.
  • FIG. 32 is a partial schematic, transverse cross-sectional view CS9 of the medical device balloon catheter of FIG. 31.
  • FIG. 33 is a partial schematic, longitudinal cross-sectional view of the distal end of a medical device balloon catheter according to the present disclosure.
  • FIG. 34 is a partial schematic, transverse cross-sectional view CS10 of the medical device balloon catheter of FIG. 33.
  • FIG. 35 is a partial schematic, longitudinal cross-sectional view of the distal end of a medical device balloon catheter according to the present disclosure.
  • FIG. 36 is a partial schematic, transverse cross-sectional view CS11 of the medical device balloon catheter of FIG. 35.
  • FIG. 37 is a schematic, perspective view of a medical device catheter according to the present disclosure.
  • FIG. 38 is a partial schematic, longitudinal cross-sectional view of the distal end of a medical device catheter according to the present disclosure.
  • FIG. 39 is a partial schematic, transverse cross-sectional view CS12 of the medical device catheter of FIG. 38.
  • FIG. 40 is a schematic, perspective view of a medical device catheter according to the present disclosure.
  • FIG. 41 is an enlarged detailed view of FIG. 40, showing part of a distal portion of the catheter and the internal features and elements of a distal portion of the adapter.
  • FIG. 42 is a partial schematic, longitudinal cross-sectional view of the distal end of a medical device catheter according to the present disclosure.
  • FIG. 43a is a partial schematic, transverse cross-sectional view CS13 of the medical device catheter of FIG. 42.
  • FIG. 43b is a partial schematic, transverse cross-sectional view CS13 of the medical device catheter of FIG. 42.
  • FIG. 44 is a partial schematic, longitudinal top view of the distal end of a medical device catheter according to the present disclosure, showing the internal features and elements of a distal portion of the medical device catheter.
  • FIG. 45 is a partial schematic, longitudinal top view of the distal end of a medical device catheter according to the present disclosure, showing the internal features and elements of a distal portion of the medical device catheter.
  • FIG. 46 is a partial schematic, longitudinal cross-sectional view of a cavitation bubble chamber and proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure.
  • FIG. 47 is a partial schematic, longitudinal top view of a medical device catheter according to the present disclosure, showing the internal features and elements of a cavitation bubble chamber and proximal portion of a guidewire lumen of the medical device catheter.
  • FIG. 48 is a partial schematic, longitudinal cross-sectional view of a cavitation bubble chamber and proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure.
  • FIG. 49 is a partial schematic, transverse cross-sectional view CS14 of the medical device catheter of FIG. 48.
  • FIG. 50 is a partial schematic, longitudinal cross-sectional view of a cavitation bubble chamber and proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure.
  • FIG. 51a is a partial schematic, longitudinal cross-sectional view of a cavitation bubble chamber and proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure.
  • FIG. 51b is a partial schematic, longitudinal side view of a cavitation bubble chamber and proximal portion of a guidewire lumen of a medical device catheter according to the present disclosure, showing internal features and elements of the medical device catheter.
  • FIG. 52 is a partial schematic, longitudinal cross-sectional view of a medical device catheter according to the present disclosure.
  • FIG. 53 is a partial schematic, longitudinal cross-sectional view of a tube forming a portion of a cavitation bubble chamber of a medical device catheter according to the present disclosure.
  • FIG. 54 is a partial schematic, longitudinal cross-sectional view of a tube forming a first cavitation solution lumen of a medical device catheter according to the present disclosure.
  • an adapter may be constructed to have a proximal portion that interfaces with a medical device or parent module and a distal portion that modifies, augments, or extends the configuration or intended use of the medical device.
  • the medical device may be a catheter.
  • the adapter or adapter module is also a medical device and can be thought of as an accessory to the parent module medical device, augmenting the performance or functionality.
  • an attachment mechanism of the adapter may secure the adapter to the distal end of the medical device catheter during use.
  • the distal portion of the adapter may extend distally from the distal end of the catheter and is designed with features that expand, augment, or modify the configuration or intended use of the medical device catheter, such as with lithotripsy functionality as described further herein.
  • the proximal portion of the adapter may be designed to couple, such as through an interference fit, with an internal lumen of the medical device such that during subsequent use the adapter remains securely attached.
  • the proximal portion may be additionally designed to be easily inserted into the internal lumen of a medical device.
  • the proximal portion of the adapter may include an attachment mechanism, more completely described below, that provides securement between the adapter and medical device.
  • the adapter and medical device comprise two modules of a modular medical device catheter system.
  • the attachment mechanism allows an adapter module and a medical device module, also referred to as the parent module, to be combined as required by the physician or physician’s staff in the operating room during a medical procedure to create a modular medical device catheter system.
  • Varying combinations of adapter modules, or adapters and parent modules or parents, allows multiple variants of a medical device catheter to be flexibly created according to the dynamic needs and challenges of each patient and procedure.
  • the modular medical device catheter system according to the present disclosure provides the physician with the benefit of flexibility to construct a medical device catheter of their choosing, combining structural, therapeutic, and diagnostic elements at the distal end for a specific procedural need. It also provides the hospital with inventory benefits, i.e. more medical device catheter variants from fewer inventory items or modules.
  • the medical device or parent module typically has a proximal end that remains outside the body of the patient and a distal end that goes inside the body of the patient.
  • parent modules include but are not limited to: balloon catheters, stent delivery system catheters, transcatheter replacement valves and associated delivery catheters, stent graft delivery catheters, dissection repair catheters, atherectomy catheters, ablation catheters, aspiration catheters, and thrombectomy catheters.
  • the adapter module of a modular medical device catheter system includes an internal lumen
  • additional adapter modules can be added using this internal lumen to further add features, creating an enhanced modular medical device catheter, such as a parent plus a plurality of adapters.
  • the modular arrangement allows a parent and adapter combination to become a parent in a new parent and adapter combination.
  • the adapter may also include conductors to transmit electrical signals from outside the patient body to the distal end of the parent device.
  • One application of this may be an adapter with a distal portion that includes electrodes powered or activated in a manner similar to an electrophysiology catheter.
  • the conductor in electrophysiology catheters are sometimes fine scale copper magnet wire, e.g. 35 gauge, or other polymer coated wire conductors, and similar conductors could be used in an electrophysiology adapter.
  • Conductors may be housed inside the central tube, electrically connecting the distal portion of the adapter to outside the patient.
  • the tube, wire or mandrel could extend proximally all the way out the proximal end of the target catheter or device.
  • a medical device catheter having improved functionality, such as through the incorporation of lithotripsy elements and functionality as described further herein.
  • the catheter may either be utilized as part of a modular catheter system as described, for example, with reference to FIGS. 1 - 28, or as a unitary catheter design as described, for example, with reference to FIGS. 29 - 54, among other relevant disclosures.
  • the unitary catheter may be a balloon catheter incorporating lithotripsy elements and functionality.
  • a medical device catheter may comprise a first tube comprising a first cavitation solution lumen having a distal opening; and a second tube housing the first tube and comprising a cavitation bubble chamber, a second cavitation solution lumen in fluid communication with the first cavitation solution lumen through the distal opening, and a distal plug at a distal end of the cavitation bubble chamber to create a distal boundary of the cavitation bubble chamber.
  • a proximal rapid exchange guidewire exit may be positioned distal to the distal boundary of the cavitation bubble chamber and in communication with a guidewire lumen.
  • a first powered electrode may extend through the first tube and the first cavitation solution lumen and cavitation bubble chamber and into the distal plug beyond the distal boundary of the cavitation bubble chamber.
  • a portion of the second tube may overlap a portion of the guidewire lumen.
  • a distal end of the second tube may comprise a distal edge that extends beyond a proximal edge of the second tube and the distal edge may overlap the portion of the guidewire lumen.
  • the first powered electrode may overlap a portion of the guidewire lumen.
  • the distal opening of the first cavitation solution lumen may be proximal to the distal boundary of the cavitation bubble chamber.
  • At least a portion of the second cavitation solution lumen may be disposed around the outside of the first tube.
  • At least a portion of the second tube may form the cavitation bubble chamber and at least a portion of the second cavitation solution lumen.
  • a distal end of the first tube may comprise a distal edge that extends beyond a proximal edge of the tube.
  • the first tube may be biased off-axis relative to the second tube.
  • the first powered electrode may be biased off-axis relative to the first tube or the second tube.
  • a portion of the second tube may be disposed between a portion of the first powered electrode and a portion of the guidewire lumen.
  • a portion of the first powered electrode may be disposed between a portion of the second tube and a portion of the guidewire lumen.
  • a second powered electrode may be disposed outside of the first tube.
  • At least one intermediate electrode may be disposed outside of the first tube to create a first electrode gap between the at least one intermediate electrode and the first powered electrode, and a second electrode gap between the at least one intermediate electrode and the second powered electrode.
  • the at least one intermediate electrode comprises a semi-circular cylinder.
  • the at least one intermediate electrode may be coaxial with the first cavitation solution lumen.
  • the first powered electrode does not comprise an insulative coating in the region of the cavitation bubble chamber.
  • a polymer jacket may form at least a portion of the second tube and the cavitation bubble chamber.
  • an inflatable balloon may be positioned proximal to the cavitation bubble chamber.
  • a portion of the guidewire lumen may comprise a third tube.
  • the second tube may comprise an elongated element of an IVL adapter for use with a modular medical device catheter system, including adapter features described with reference to FIGS. 1 - 28, for example.
  • an elongated element of an IVL adapter for use with a modular medical device catheter system, including adapter features described with reference to FIGS. 1 - 28, for example.
  • the electrodes referenced throughout the present disclosure may be positioned or otherwise configured to create a shockwave and cavitation bubbles in a cavitation solution for intravascular lithotripsy therapies, for example.
  • the positioning, operation and function of the electrodes will be apparent with reference to the figures and description provided further herein.
  • FIG. 1 is a schematic, perspective, view of an electrical adapter 500 according to an aspect of the present disclosure.
  • Electrical adapter 500 includes a distal portion 501, which includes an electrical active element 294 and runway 474.
  • Electrical adapter 500 includes a distal end 477 and a proximal end 478.
  • Electrical adapter 500 includes a proximal portion 504 that incorporates an attachment mechanism 467 and elongate body 460.
  • Electrical adapter 500 also includes a tubular extension 471 and electrical connector 472.
  • FIG. 2 is an enlarged detailed view of the proximal portion 504 of electrical adapter 500, distal portion 501 of electrical adapter 500, attachment mechanism 467, and elongate body 460.
  • Attachment mechanism 467 includes elongated element or central tube 462 and interfacing elements 470.
  • Elongate body 460 includes a tubular extension 471, extending from the proximal end 466 of central tube 462.
  • the distal portion 501 includes a distal exit 468 for a central lumen 465 at the distal end 477 of the adapter 500.
  • FIG. 3 is an enlarged detailed view of the proximal end 478 of electrical adapter 500 showing a proximal exit 469 for a central lumen 465 at the proximal end 478 of adapter 500, tubular extension 471, and electrical connector 472 which includes ring electrical contacts 473.
  • FIG. 4 is a partial schematic, transverse, cross-sectional view of electrical adapter 500 at CS1 as illustrated in FIG. 1 showing electrical conductors 461 and second central tube 464, that creates central lumen 465, within the lumen 463 of elongated element 462, as well as interfacing element 470 bonded to the outside of elongated element 462.
  • FIG. 5 is a partial schematic, transverse, cross-sectional view of electrical adapter 500 at CS2 as illustrated in FIG. 1 showing tubular extension 471 of the elongated body 460 which provides a lumen or conduit for both the electrical conductors 461 and second central tube 464, which creates a central lumen 465.
  • FIGS. 1 - 5 show electrical adapter 500, which includes a distal portion 501 that may comprise, for example, electrically active elements 294 such as intravascular ultrasound (IVUS) transducers, lithotripsy electrodes, pressure sensors, imaging sensors, thermocouples, ablation electrodes, and other features requiring electrical signal transmission or electrical power.
  • Electrical adapter 500 may also include a proximal portion 504 that incorporates an attachment mechanism 467 and elongate body 460.
  • the elongate body 460 of electrical adapter 500 includes electrical conductors 461, for example, to facilitate electrical communication between the electrical connector 472 and electrodes described further herein. In this configuration, the conductors 461 extend proximally from the distal portion 501 of adapter 500 through the lumen
  • the second central tube 464 may be used by a physician as a guidewire lumen using over the wire techniques after the electrical medical device catheter system 600 is assembled.
  • the second central tube 464 may also be omitted from the design, for example, if a guidewire lumen is not necessary, which may be the case for rapid exchange style configurations of the adapter 500.
  • a central tube lumen 463 is not needed for a guidewire, the central tube lumen 463 could be used both as a passageway for conductors as well as an inflation lumen in alternate configurations of the distal portion 501 of the adapter 500, for example, where the adapter 500 includes a balloon to be inflated in-vivo. In either case, the second central tube
  • proximal end 466 of central tube 462 could extend proximal to or past the proximal end 219 of a medical device catheter 201 (shown in FIG. 6 and FIG. 7, for example). It may be advantageous for the proximal end 466 of central tube 462 to only extend far enough for the attachment mechanism 467 to incorporate compressible interfacing elements 470 to ensure secured coupling between the adapter 500 and a medical device catheter 201.
  • the compressible interfacing elements 470 are designed to compress to interface with a lumen 211 at the distal end 213 of medical device catheter 201 to secure the electrical adapter 500 at the distal end 213 of medical device catheter 201.
  • proximal end 466 of central tube 462 could extend to a position proximal to a proximal end 219 of a medical device catheter 201. It may be advantageous when using the adapter 500 to have the conductors 461 bonded or attached to the outer surface of the second central tube 464. Alternatively heat shrink tubing, such as thin-walled polyester heat shrink tubing, could be used to hold the conductors 461 against the outer surface of the second central tube 462 in regions proximal to the proximal end 466 of central tube 462, creating a cohesive structure.
  • Another alternative is to reflow a polymer jacket around the conductor 461 and second central tube 464 configurations in a manner similar to other catheter manufacturing techniques, such as guide catheter manufacturing.
  • Another alternative is to incorporate a metallic or polymer spiral or coil around the length of the conductor 461, second central tube 464, and central tube 462 configuration in a manner similar to a conventional .035” guidewire and provide the buckling stability of a guidewire.
  • FIG. 4 is transverse cross-sectional view at location “CS1” of FIG. 1 and FIG. 2, illustrating an example of a nine (9) conductor 461 configuration.
  • the electrical conductors 461 may comprise standard round 42 AWG magnet wire, for example. It can be appreciated that the configuration, geometry, and number of electrical conductors can be tailored to the requirements of the electrically active elements of the adapter 500.
  • FIG. 5 is a transverse cross-sectional view at location “CS2” of FIG. 1, illustrating elongate body 460 for adapter 500 which includes a tubular extension 471, extending from the proximal end 466 of central tube 462.
  • Tubular extension 471 provides a conduit for both the electrical conductors 461 and second central tube 464.
  • the electrical conductors 461 can extend proximally from any electrically active elements 294 at distal portion 501 to a position proximal to the proximal end 219 of a medical device catheter 201, with or without central tube 462, second central tube 464, or tubular extension 471 also extending to a position proximal to the proximal end 219 of a medical device catheter 201.
  • electrically active elements could be positioned proximal to the attachment mechanism 467 instead of at the distal portion 501.
  • the proximal end 478 of adapter 500 may comprise electrical connector 472 in electrical communication with the electrodes described further in the present disclosure.
  • Connector 472 may comprise a ring electrical contact 473 for each conductor 461 used, for example, nine (9) ring electrical contacts 473 for each of the nine (9) electrical conductors 461.
  • Second central tube 464 may include a distal exit 468 for lumen 465 at the distal end 477 of the adapter 500 and a proximal exit 469 at the proximal end 478 of adapter 500.
  • FIG. 6A is a partial schematic, perspective view of a balloon catheter or parent module 201, which is a medical device catheter, which includes a lumen 211 at the distal end 213, before electrical adapter 500 is attached to the distal end 213 of the balloon catheter 201, and with inflatable balloon 202 represented as inflated for the purposes of illustration.
  • a balloon catheter or parent module 201 which is a medical device catheter, which includes a lumen 211 at the distal end 213, before electrical adapter 500 is attached to the distal end 213 of the balloon catheter 201, and with inflatable balloon 202 represented as inflated for the purposes of illustration.
  • FIG. 6B is a partial schematic, perspective view of electrical adapter 500, according to an aspect of the present disclosure, attached to the distal end 213 of a balloon catheter 201, and with the inflatable balloon 202 represented as inflated for the purposes of illustration.
  • the electrically active element 294 of distal portion 501 is distal to the distal end 213 of balloon catheter 201.
  • the proximal end 478 of electrical adapter 500 and electrical connector 472 are proximal to the proximal end 219 of balloon catheter 201.
  • Balloon catheter 201 includes a catheter shaft 203 to connect inflatable balloon 202 to a fitting assembly 215.
  • FIG. 7 is a schematic, perspective view of an assembled electrical modular catheter system 600 according to an aspect of the present disclosure.
  • Assembled electrical modular catheter system 600 is a combination of medical device catheter 201 (also known as the parent module), electrical adapter 500, and proximal module 502.
  • Proximal module 502 includes an electrical connector interface 503 and is attached to the proximal end 219 of fitting assembly 215 at the proximal end of the balloon catheter 201.
  • the inflatable balloon 202 of balloon catheter 201 is represented as inflated for the purposes of illustration.
  • FIG. 6A and FIG. 6B illustrate the features of medical device balloon catheter 201 which includes a distal end 213 and proximal end 219.
  • the balloon catheter 201 includes an inflatable balloon 202 positioned near the distal end 213.
  • the inflatable balloon 202 is connected to a fitting assembly 215 near the proximal end 219 of medical device balloon catheter 201 by a catheter shaft 203.
  • the catheter shaft 203 is typically a long tube with one or more lumens, at least one lumen 211 has an opening near the distal end 213.
  • FIG. 6B also illustrates electrical adapter 500 after it has been secured to medical device balloon catheter 201.
  • Electrical adapter 500 is attached to medical device balloon catheter 201 by inserting the proximal end of adapter 478 into the distal end 213 of a lumen 211 of balloon catheter 201 until the attachment mechanism 467 has secured the adapter 500 to the balloon catheter 201.
  • Interfacing elements 470, of the attachment mechanism 467, are attached or otherwise bonded to the elongated element 462 and configured to secure the electrical adapter 500 to a medical device catheter.
  • Balloon catheter 201 is shown with the inflatable balloon 202 in an inflated state for illustration purposes but would normally be in a deflated state during the attachment of adapter 500 to balloon catheter 201.
  • electrical adapter 500 could be attached to any other appropriate medical device catheter 201, for example a stent delivery system.
  • Balloon catheter 201 may also include a fitting assembly 215 near the proximal end 219 of medical device balloon catheter 201 that includes a port to inflate the balloon and a port for “over-the-wire” guidewire access.
  • the lumen 211 of a balloon catheter 201 is typically available to be used with a guidewire during a minimally invasive medical procedure.
  • electrical adapter 500 distal portion 501 may comprise, for example, electrically active elements 294, near the distal end 213 of the parent medical device catheter 201.
  • FIG. 7 illustrates the electrical adapter 500 after it has been secured to a medical device balloon catheter 201 and after a proximal module 502 has been attached to the proximal end 219 of the balloon catheter 201 and the proximal end 478 of electrical adapter 500.
  • Proximal module 502 may include an electrical connector interface 503 to provide an electrical connection between the ring electrical contacts 473 of electrical connector 472 and a user interface or equipment for the electrically active adapter 500.
  • FIG. 8 is a schematic, perspective view of an over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505 according to an aspect of the present disclosure.
  • OTW IVL adapter 505 includes a distal portion 506, which includes a distal exit 468 for a central lumen 465 at a distal end 480.
  • OTW IVL adapter 505 also includes an attachment mechanism 467, elongate body 482, proximal end 479, proximal electrical connector 481, which includes ring electrical contacts 47.
  • OTW IVL adapter 505 also includes proximal exit 469 at the proximal end 478 of OTW IVL adapter 505.
  • FIG. 9 is an enlarged detailed view, showing distal portion 506 of over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505, the attachment mechanism 467, and tubular extension 471 among other features.
  • Distal portion 506 has a distal end 480 and includes runway 474, an outer tube 484, and the proximal and distal jacket or coverings 492 and 493 at the ends of outer tube 484.
  • Attachment mechanism 467 includes elongated element 462 and interfacing elements 470.
  • Elongated element 462 has a proximal end 466.
  • FIG. 9 also shows elongate body 482.
  • FIG. 10 is an enlarged detailed view, showing distal portion 506 of over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505, like FIG. 9, but with outer tube 484 not shown to illustrate a cavitation bubble chamber 491, first electrode 486, second electrode 487, intermediate electrode 485, chamber separator 490, proximal plug 488, and distal plug 489.
  • OW over-the-wire
  • IVL intravascular lithotripsy
  • FIG. 11 is a partial schematic, longitudinal view of over-the-wire (OTW) intravascular lithotripsy (IVL) adapter 505 according to an aspect of the present disclosure.
  • OTW IVL adapter 505 includes a distal portion 506, which includes a distal exit 468 for a central lumen 465 at a distal end 480 and includes runway 474, an outer tube 484, and the proximal and distal jacket or coverings 492 and 493 at the ends of outer tube 484.
  • OTW IVL adapter 505 also includes an attachment mechanism 467 and elongate body 482.
  • FIG. 11 also illustrates long or longitudinal axis 498 of the adapter 505 and cavitation bubble chamber 491.
  • FIG. 13 is a partial schematic, transverse, cross-sectional view of OTW IVL adapter 505 at CS4 as illustrated in FIG. 11 showing outer tube 484, first electrode 486, second electrode 487, intermediate electrode 485, second central tube 464, cavitation bubble chamber 491, proximal plug 488, and proximal jacket or covering 492.
  • FIG. 14 is a partial schematic, transverse, cross-sectional view of OTW IVL adapter 505 at CS5 as illustrated in FIG. 11 showing outer tube 484, second electrode 487, intermediate electrode 485, second central tube 464, cavitation bubble chamber 491, chamber separator 490, and proximal jacket or covering 492
  • FIG. 15 is an enlarged detailed view of distal portion 506 of OTW IVL adapter 505 like FIG. 9, but with outer tube 484, proximal jacket or covering 492, and distal jacket or covering 493 not shown to illustrate a cavitation bubble chamber 491, chamber separator 490, proximal plug 488, and distal plug 489.
  • FIG. 15 also illustrates two needles 494A and B, which may be used to puncture the proximal plug 488 and distal plug 489, forming the boundary of the cavitation bubble chamber 491 along with the outer tube 484 (not shown), with the sharp tip of the needles 494At and/or 494Bt, penetrating and entering the cavitation bubble chamber 491.
  • the lumen 463 of the central tube 462 of the elongate body 482 could be used to fill the cavitation bubble chamber 491 with an appropriate solution during a procedure.
  • the cavitation bubble chamber 491 is formed by an outer tube 484 located at distal portion 506 (note FIG. 10 illustrates distal portion 506 of adapter 505 without the outer tube 484 to show the internal features and elements relating to the cavitation bubble chamber 491). Additionally, the outer tube 484 is enclosed by a proximal plug 488 and a distal plug 489.
  • the proximal plug 488 and distal plug 489 can be made from a polymer, typically through a molding manufacturing process or an extrusion process, with secondary reflow or bonding processes to enclose the proximal and distal ends of the outer tube 484 thereby creating the cavitation bubble chamber 491.
  • a center chamber separator 490 to separate the chamber into two spaces where a cavitation bubble can be created between two distinct electrode sets, first electrode 486 and intermediate electrode 485, and second electrode 487 and intermediate electrode 485.
  • the chamber separator 490 can also serve to support the center of the intermediate electrode 485, while the proximal plug 488 and distal plug 489 support the ends of the intermediate electrode 485.
  • first electrode 486 and intermediate electrode 485, and second electrode 487 are illustrated as wires of various cross sections running parallel to each other along the long or longitudinal axis 498 of the adapter 505 and cavitation bubble chamber 491.
  • the second electrode 487 and first electrode 486 may be configured as flat wires with a rectangular cross section, where the intermediate electrode 485 may be configured as a round wire, with a circular cross section.
  • Other cross-sectional shapes could be useful, such as electrode wire with triangular cross sections.
  • Electrodes can happen anywhere along the parallel lengths where the electrodes are mutually exposed (do not have electrical insulating coatings or covering). This may allow more cycles of arcing or spark generation because as the electrode wears with repeated arcing cycles the arcing can migrate to a fresh wire location farther along the parallel electrode wire set length.
  • These electrodes may suitably be manufactured from copper, graphite, tungsten, stainless steel or other appropriate conducting materials.
  • the cavitation bubble chamber 491 is filled with the cavitation solution during the manufacturing process and will be in contact with the electrodes 487, 486 or 485, it may be advantageous to coat the conducting material with gold or other protective coating to minimize oxidation during an extended period of storage, such as during the shelf life of the product.
  • conductive wire is used as electrode 487 and 486, this wire can extend through the elongated body 482 to the ring electrical contacts 473 in electrical connector 481 of electrical adapter 505, to provide electrical continuity for communication with high voltage pulse generator 457 (such as shown with respect to FIG. 22).
  • the electrodes 487 and 486 can be electrically connected to other electrical conductors 461 within or proximal to the cavitation bubble chamber 491 which are then electrically connected to the appropriate ring electrical contacts 473 in electrical connector 481 of adapter 505, such as shown in FIG. 8.
  • FIG. 15 illustrates distal portion 506 of OTW IVL adapter 505 without the outer tube 484, or the proximal and distal jacket or coverings 492 and 493 such as shown in FIG. 10. This is done to show the internal features and elements related to the cavitation bubble chamber 491.
  • two needles 494A and B may be used to puncture the proximal plug 488 and distal plug 489 that form the boundary of the cavitation bubble chamber 491 along with the outer tube 484 (not shown), with the sharp tip of the needles 494At and/or 494Bt, penetrating and entering the cavitation bubble chamber 491.
  • the cavitation solution may then be injected through the lumen of one or both of the needles 494A, B to fill the cavitation bubble chamber 491. It may be advantageous to inject the cavitation solution through one of the lumens of the needles 494A or B, while the other needle allows entrapped air to escape to enable a more complete filling of the cavitation bubble chamber 491.
  • proximal jacket 492 and distal jacket 493 could be formed from a polymer and bonded, welded or attached to the distal portion 506. Alternatively, it may be advantageous to laser weld the puncture sites to seal the cavitation bubble chamber 491, among other techniques as may be appreciated in the art.
  • FIG. 16 is a schematic, perspective view of a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to an aspect of the present disclosure.
  • RX IVL adapter 510 includes a distal portion 511.
  • RX IVL adapter 510 includes a distal end 475 and a proximal end 476.
  • RX IVL Adapter 510 incorporates an attachment mechanism 467 and elongate body 495.
  • RX IVL Adapter 510 also includes a tubular extension 471 and electrical connector 496, which includes tab electrical contacts 497.
  • FIG. 17 is an enlarged detailed view of a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to an aspect of the present disclosure illustrated in FIG. 16, showing distal portion 511 of RX IVL adapter 510, the attachment mechanism 467, elongate body 495, distal end 475, and proximal end 466 of elongated element, also known as central tube 462.
  • Distal portion 511 includes rapid exchange lumen 513 with a distal end 514 and a proximal end 515, and runway 474.
  • Attachment mechanism 467 includes interfacing elements 470 and elongated element 462.
  • FIG. 18 is a partial schematic, perspective view of a rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to an aspect of the present disclosure, attached to a distal end 213 of a balloon catheter 201, where the inflatable balloon 202 is represented as inflated for the purposes of illustration, and a guidewire 516 is passing through distal end 514 and proximal end 515 of rapid exchange lumen 513 (illustrated in FIG. 17 and FIG. 21). Also illustrated in FIG. 18 is junction 524 between the distal portion 511 and distal end 213 of balloon catheter also known as parent module 201.
  • Distal portion 51 1 of RX IVL adapter 510 includes cavitation bubble chamber 520 (illustrated in FIG. 21) which has a distal end 528 and a proximal end 527.
  • FIG. 19 is a partial schematic, longitudinal view of rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 according to an aspect of the present disclosure illustrated in FIG. 16, showing distal portion 511 of RX IVL adapter 510, Distal portion 511 includes rapid exchange lumen 513 (illustrated in FIG. 17 and FIG. 21) with a distal end 514 and a proximal end 515, runway 474, cavitation bubble chamber 520 (illustrated in FIG. 21) which has a distal end 528 and a proximal end 527.
  • FIG. 19 also shows longitudinal or long axis 509 of the RX IVL adapter 510.
  • FIG. 21 is a partial schematic, transverse, cross-sectional view of RX IVL adapter 510 at CS7 as illustrated in FIG. 19 showing cavitation bubble chamber 520, which is also the lumen of a cavitation bubble tube 521, a first powered electrode 518, a second powered electrode 519, a ground electrode 517, electrode gap 522 between electrodes, rapid exchange lumen 513 formed by a rapid exchange tube 512 surrounded by a polymer body 523. Also shown is interfacing element 470.
  • FIGS. 16 - 21 illustrate another example intravascular lithotripsy (IVL) adapter 510 according to the present disclosure.
  • Adapter 510 comprises a distal portion 511, an elongate body 495 similar to 460 described previously, attachment mechanism 467 and electrical connector 496 with tab electrical contacts 497.
  • Electrical conductors 461 electrically connect the three (3) tab contacts 497 on electrical connector 496 with the three (3) electrodes in the cavitation bubble chamber 520, a first powered electrode 518, a second powered electrode 519, and a ground electrode 517.
  • Rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 has a distal end 475 and a proximal end 476.
  • Distal portion 511 of RX IVL adapter 510 includes a rapid exchange lumen 513 (shown in FIG. 21) with a distal end 514 and a proximal end 515, the proximal end 515 is distal to the distal end 213 of the parent medical device catheter 201 (such as shown in FIG. 18), after the RX IVL adapter 510 has been attached to the distal end of the medical device catheter 201 by inserting the proximal end 476 of adapter 510 into a lumen 211 at the distal end 213 of medical device catheter 201.
  • the distal portion 511 of RX IVL adapter 510 includes a runway 474 (also shown with reference to FIG 9 - 1 1 and 17-19).
  • runway 474 After attaching the RX IVL adapter 510 to parent module (balloon catheter) 201 a portion of the runway 474 fits within a lumen 211 at the distal end 213 of parent module 201.
  • runway 474 is smaller than the lumen 211 at the distal end 213 of parent module 201 and is comprised of a polymer bonded or attached to the central tube 462.
  • a purpose of the runway 474 is to provide a robust transition or junction 524 between the distal portion 511 of RX IVL adapter 510 and distal end 213 of parent module (balloon catheter) 201.
  • the runway 474 would be designed to minimize kinking or buckling at the junction 524 between the distal portion 511 and distal end 213 of the parent module 201.
  • the design of the runway 474 could include stainless steel braiding or higher durometer polymers to aid in providing a stable junction 524, for example.
  • the rapid exchange lumen 513 is designed through the choice of geometry and material to function as a rapid exchange lumen 513 for a guidewire 516 (shown in FIG. 18) to be used during a medical procedure.
  • the rapid exchange lumen 513 could be formed by a separate rapid exchange tube 512 surrounded by a polymer body 523 (shown, for example, in FIG 21).
  • a suitable rapid exchange tube 512 could be a thin walled, approximately .002” to .001”, polyimide tube.
  • the distal portion 511 of RX IVL adapter 510 also comprises a cavitation bubble chamber 520, which is also the lumen of a cavitation bubble tube 521.
  • the cavitation bubble chamber 520 can be filled with a cavitation solution similar to cavitation bubble chamber 491 described previously.
  • Cavitation bubble chamber 520 has a distal end 528 and a proximal end 527. Cavitation bubble chamber 520 can also include an opening at the distal end 528 to facilitate filling the cavitation bubble chamber 520 with a cavitation solution by allowing any entrapped air bubbles or vapor bubbles to escape.
  • the cavitation bubble chamber 520 Within the cavitation bubble chamber 520 are three (3) electrodes, including a first powered electrode 518, a second powered electrode 519, and a ground electrode 517.
  • the three (3) electrodes 517, 518, and 519 are illustrated as wires of round cross sections running parallel to each other along the longitudinal or long axis 509 of the adapter 510 and cavitation bubble chamber 520.
  • the proximal end 515 of the rapid exchange lumen 513 is just proximal to the proximal end 527 of the cavitation bubble chamber 520.
  • the proximal end 515 of the rapid exchange lumen 513 could be located anywhere between the distal end 528 of the cavitation bubble chamber 520 and the proximal end 527 of the cavitation bubble chamber 520.
  • the distal portion 511 of RX IVL adapter 510 configured with the proximal end 515 of the rapid exchange lumen 513 distal to the distal end 528 of the cavitation bubble chamber 520.
  • the rapid exchange lumen 513 would not have a portion running parallel to, or side by side with, the cavitation bubble chamber 520, as shown in FIG. 21, but could be characterized as a serial configuration, meaning the rapid exchange lumen 513 is more in line with cavitation bubble chamber 520.
  • An advantage of the serial configuration would be a lower profile distal portion 511 with the drawback or tradeoff of a potentially longer distal portion 511.
  • the first powered electrode 518 and the second powered electrode 519 may also have an insulated coating that has been selectively removed or selectively applied such that a spark that generates a shockwave and cavitation plasma bubble 526 will be created across the electrode gap 522 at particular, or controlled uninsulated portions or locations along the length of the cavitation bubble chamber 520.
  • FIG. 24 illustrates a tubular electrode assembly 540 that could be incorporated into intravascular lithotripsy adapters according to an aspect of the present disclosure.
  • Tubular electrode assembly 540 includes a series of tubular electrode elements 541 having a proximal end 544 and distal end 545 arranged in an end-to-end fashion, where the tubular electrode assembly 540 has a distal end 543 and proximal end 542.
  • FIG. 25 is a partial schematic, transverse, cross-sectional view of a RX IVL adapter similar to RX IVL adapter 510.
  • the cross-sectional view is like that of FIG. 21 showing section CS7 as illustrated in FIG. 19, but showing a cross-sectional view of a RX IVL adapter with tubular electrode assembly 540 at a location CS8 of FIG. 24.
  • FIG. 25 illustrates tubular electrode elements 541 assembled in a cavitation bubble tube 521 forming cavitation bubble chamber 520, and electrode gap 546 between adjacent tubular electrode elements 541.
  • FIG. 25 illustrates the other features, rapid exchange lumen 513 formed by a rapid exchange tube 512 surrounded by a polymer body 523, and interfacing element 470.
  • FIG. 24 and FIG. 25 illustrate an example of a suitable electrode configuration according to the present disclosure.
  • a series of tubular electrode elements 541 are arranged end to end, into a tubular electrode assembly 540.
  • nine (9) tubular electrode elements 541 are arranged in a series forming the tubular electrode assembly 540 having eight (8) electrode gaps 546.
  • the tubular electrode element 541 can be manufactured by laser cutting the spiral shape from tubular stock of an appropriate material with the required diameter and wall thickness.
  • the electrode gap 546 is formed between the proximal end 544 of a tubular electrode element 541 and the distal end 545 of an adjacent tubular electrode element.
  • the shape could be a circumferential ring, where an appropriate electrode gap is configured between adjacent circumferential ring electrode elements.
  • the tubular electrode element 541 at the proximal end 542 of the tubular electrode assembly 540 is electrically connected to one side of a high voltage pulse generator 457 (such as shown in FIG. 22) and the other electrical side of the high voltage pulse generator is electrically connected to the tubular electrode element 541 at the distal end 543 of the tubular electrode assembly 540.
  • a high voltage pulse generator 457 such as shown in FIG. 22
  • the other electrical side of the high voltage pulse generator is electrically connected to the tubular electrode element 541 at the distal end 543 of the tubular electrode assembly 540.
  • the tubular electrode assembly 540 could be incorporated into a distal portion of an adapter similar to distal portion 511 of adapter 510 described previously, but wherein the tubular electrode assembly 540 forms the cavitation bubble chamber 520.
  • Cross- sectional view CS8 of FIG. 25 illustrates the adapter incorporating tubular electrode assembly 540 similar to RX IVL adapter 510 and the cross sectional view CS7 of FIG. 21 previously described, where the section arrows of FIG. 24 show approximate location of section CS8 of adapter 510 incorporating tubular electrode assembly 540.
  • Electrode pair configurations, or electrode sets could include pairing a tubular electrode element with a wire or other electrode element.
  • electrodes 517, 518, and 519 are positioned at the proximal portion 529, just proximal to the attachment mechanism 467 and just distal to the tubular extension 471.
  • the shockwave generating electrodes can be positioned in the location of the inflatable balloon 202 of an angioplasty balloon catheter parent module 201, instead of in the distal portion 531, distal to the balloon of an angioplasty balloon catheter parent module.
  • the cavitation bubble chamber region in this case the region of the lumen 211 of the balloon catheter 201 where the electrode set 517, 518, and 519 are positioned, can be filled with a cavitation solution similar to cavitation bubble chamber 520 described previously.
  • Distal portion 531 can also include an opening 539 at the distal end to facilitate filling with a cavitation solution by allowing any entrapped air bubbles or vapor bubbles to escape.
  • FIG. 27 is partial schematic view of an intravascular lithotripsy (IVL) adapter according to an aspect of the present disclosure, showing cutaway section view of distal portion 532A.
  • Distal portion 532A includes a cavitation bubble chamber 520 with a distal end 528 and proximal end 527, runway 474, and codinear, end-to-end electrodes, 536 and 537, within cavitation bubble chamber 520.
  • FIG. 28 is partial schematic view of an intravascular lithotripsy (IVL) adapter according to an aspect of the present disclosure, showing cutaway section view of distal portion 532B.
  • Distal portion 532B includes a cavitation bubble chamber 520 with a distal end 528 and proximal end 527, runway 474, and parallel, end-to-end electrodes, 533 and 534, within cavitation bubble chamber 520.
  • the electrodes in the distal portions 506 and 511, respectively can be configured in an end-to-end configuration of distal portion 532A and distal portion 532B as shown in FIG. 27 and FIG. 28.
  • FIG. 27 and FIG. 28 are longitudinal views with partial cutaway cross-sections of distal portions 532A and 532B to illustrate the interior of a cavitation bubble chamber 520 and alternate electrode configurations.
  • FIG. 27, illustrates a pair of co-linear, end-to-end electrodes, 536 and 537, within cavitation bubble chamber 520.
  • FIG. 28 illustrates a pair of parallel, end- to-end electrodes, 533 and 534, within cavitation bubble chamber 520. Applying a sufficiently high voltage potential difference between the set of electrodes 533 and 534 will induce arcing or sparking, generating a shockwave, at the electrode gap 535 between the ends of electrodes 534 and 533 within the cavitation solution, and associated cavitation bubble.
  • FIG. 29 and FIG. 30 illustrate the features of a medical device balloon catheter 700 which includes a distal end 713 and proximal end 719.
  • the balloon catheter 700 includes an inflatable balloon 702 positioned near the distal end 713.
  • the inflatable balloon 702 is connected to a fitting assembly 715 near the proximal end 719 of medical device balloon catheter 700 by a catheter shaft 703.
  • the catheter shaft 703 is typically a long tube with one or more lumens, and at least one lumen is used to inflate inflatable balloon 702. This inflation lumen is typically connected to an inflation device to pressurize the inflatable balloon 702, typically with saline solution, at inflation fitting 716, for example.
  • Fitting assembly 715 also includes a first cavitation solution fitting 717, and a second cavitation solution fitting 718 that are connected to a first cavitation solution lumen or cavity and a second cavitation solution lumen or cavity which creates fluid flow paths, or connections, extending between the cavitation bubble chamber and first and second cavitation solution fittings, 717 and 718.
  • Fitting assembly 715 also includes an electrical connector 714 that includes at least two electrical connector pins, a first electrical connector pin 707 and a second electrical connector pin 708. Electrical connector 714 and the first and second electrical connector pins 707 and 708 respectively are adapted to electrically couple, or connect, a high voltage pulse generator to electrode pairs in the cavitation bubble chamber.
  • the medical device balloon catheter 700 of FIGS. 29 - 36 is a balloon catheter that may also be conceptualized as an integrated, unitary or “one-piece” design version of the assembled modular catheter system, comprising an intravascular lithotripsy (IVL) adapter attached to a medical device balloon catheter described with reference to FIGS. 1 - 28.
  • IVL intravascular lithotripsy
  • medical device balloon catheter 700 may integrate the IVL features and inflatable balloon features in a “non-modular” or unitary design.
  • the distal end 713 of medical device catheter 700 is intended to be inserted into a body lumen, such as a vessel, artery, vein, or duct to deliver the shockwave energy and angioplasty in the form of an inflatable and pressurized balloon 702.
  • the proximal end 719 is intended to stay outside the body of the patient and is where the user interfaces with the medical device catheter 700, such as connecting a high voltage pulse generator, pressurizing the inflatable balloon 702, and circulating cavitation solution to the distal end 713.
  • FIG. 31 is partial schematic, longitudinal cross-sectional view of a medical device balloon catheter 700 according to an aspect of the present disclosure, showing a sectional view of a portion of medical device catheter 700, including the features at the distal end 713.
  • Medical device balloon catheter 700 includes a guidewire lumen 711 formed by a guidewire tube 704, which extends coaxially through a cavitation bubble chamber 720, an intermediate electrode 725, and the inflatable balloon 702.
  • Cavitation bubble chamber 720 is formed by a tube, cavitation bubble chamber tube 721.
  • Medical device balloon catheter 700 may also include a first electrode 726, a second electrode 727, and a single cavitation solution cavity 722 that extends from the cavitation bubble chamber 720 at the distal end 713 through the inflatable balloon 702 to a location outside the body of the patient, for example at the fitting assembly 715 near the proximal end 719 of medical device balloon catheter 700.
  • a single cavitation solution cavity 722 When only a single cavitation solution cavity 722 is required, only one of the cavitation solution fittings, for example first cavitation solution fitting 717 as shown in FIG. 29, is needed. In this case, the single cavitation solution cavity 722 creates fluid flow paths, or connections, extending between the cavitation bubble chamber 725 and first cavitation solution fittings, 717.
  • Medical device balloon catheter 700 may also include an inflatable balloon 702 that transitions to a distal balloon tail 705 that seals the distal end of the inflatable balloon 702 near the distal end 713.
  • the distal balloon tail 705 may be composed of a polymer that is the same as the inflatable balloon 702 and forms the outer surface of this portion of the balloon catheter 700, where a similar or compatible polymer may typically be formed into a taper at the distal end 713 where the distal exit of the guidewire lumen 711 is located.
  • FIG. 31 also shows the electrode gap 728 between first electrode 726 and intermediate electrode 725 and electrode gap 729 between second electrode 727 and intermediate electrode 725.
  • the medical device balloon catheter 700 may also include an opening 723, such as a hole, slit, or passage near the cavitation bubble chamber 720 through the distal balloon tail 705 and cavitation bubble chamber tube 721.
  • a suitable cavitation solution such as saline solution, can be moved to create a one-way flow of solution from the first cavitation solution fitting 717, through the cavitation solution cavity 722, exiting the cavitation bubble chamber 725 at opening 723.
  • a syringe or similar device can be connected to the cavitation solution fitting 717 to inject cavitation solution to accomplish said one-way fluid movement.
  • FIG. 32 is a partial schematic, transverse cross-sectional view of medical device balloon catheter 700 at cavitation bubble chamber 720, or CS9 as illustrated in FIG. 31, and showing guidewire tube 704, guidewire lumen 711, first electrode 726, second electrode 727, cavitation bubble chamber tube 721, distal balloon tail 705, and cavitation solution cavity 722 which is a single lumen cavity.
  • the electrode configuration of intermediate electrode 725, first electrode 726, and second electrode 727 shown in FIGS. 31 and 32 are like the configuration of intermediate electrode 485, first electrode 486, and second electrode 487 as shown in FIG. 22, where a high voltage pulse generator 457 can be used to generate sparks and associated shockwaves by serially applying a high voltage potential difference between the first electrode 726 and intermediate electrode 725, and between intermediate electrode 725 and second electrode 727.
  • Electrical communication or electrical connection between the first electrode 726 and second electrode 727, and the high voltage pulse generator 457 may be established by electrically coupling or electrically connecting the first electrode 726 to the first electrical connector pin 707 and the second electrode 727 to the second electrical connector pin 708 at the electrical connector 714.
  • Electrical connector 714 may be adapted to be electrically connected to the pulse generator 457 to deliver the required high voltage pulses at electrode gaps 728 and 729.
  • the intermediate electrode 725 may comprise a metallic or conductive tube, such as a radiopaque marker band composed of platinum alloy, platinum iridium alloy, or tungsten alloy, as non-limiting examples.
  • the intermediate electrode 725 provides both the electrical path for the required sparks or arcing between electrodes as well as visible landmarks under x-ray fluoroscopy.
  • the intermediate electrode could be made of a conductive material that is not as radiopaque, such as stainless steel or copper.
  • the cavitation solution cavity 722 provides a lumen to add or refresh an appropriate cavitation solution, such as phosphate buffered saline solution, to the cavitation bubble chamber 720.
  • the slit, hole, or passage 723 may be effective at venting, allowing entrapped gases and liquids to escape, and new cavitation solution to be added to the cavitation bubble chamber 720 by way of the cavitation solution cavity lumen 722. This is similar to flushing the catheter 700 with saline solution to remove entrapped air prior to a procedure and pre-loading the cavitation bubble chamber 725 with a cavitation solution.
  • FIG. 33 is partial schematic, longitudinal cross-sectional view of a medical device balloon catheter 701 according to an aspect of the present disclosure, showing a sectional view of a portion of medical device balloon catheter 701, including features at the distal end 713.
  • Medical device catheter 701 is similar to medical device catheter 700 and includes a guidewire lumen 711 formed by a guidewire tube 704, which extends coaxially through a cavitation bubble chamber 730, an intermediate electrode 725, and the inflatable balloon 702. Cavitation bubble chamber 730 is formed by a polymer body 731.
  • Medical device catheter 701 may also include a first electrode 726, a second electrode 727, and a two cavitation solution cavities or lumens 734 and 736 that extend from the cavitation bubble chamber 730 at the distal end 713 through the inflatable balloon 702 to a location outside the body of the patient, for example at the fitting assembly 715 near the proximal end 719 of medical device balloon catheter 701.
  • Cavitation solution cavities or lumens 734 and 736 are formed by cavitation solution tubes 735 and 737 also included in medical device balloon catheter 701.
  • Medical device balloon catheter 701 may also include an inflatable balloon 702 that transitions to a distal balloon tail 705 that seals the distal end of the inflatable balloon 702 near the distal end 713.
  • the distal balloon tail 705 may typically comprise of a polymer that is the same as the inflatable balloon 702 and forms the outer surface of this portion of the balloon catheter 701, where a similar or compatible polymer is typically formed into a taper at the distal end 713 where the distal exit of the guidewire lumen 711 is located.
  • FIG. 33 also shows the electrode gap 728 between first electrode 726 and intermediate electrode 725 and electrode gap 729 between second electrode 727 and intermediate electrode 725.
  • the electrode configuration of intermediate electrode 725, first electrode 726, and second electrode 727 shown in FIGS. 33 and 34 are the same as shown in FIGS. 31 and 32.
  • the cavitation solution cavities or lumens 734 and 736 may extend to the proximal end 719 of the medical device catheter 701 to enable the user to add an appropriate cavitation solution to the cavitation bubble chamber 730.
  • the cavitation solution lumens 734 and 736 provide a way to add or refresh an appropriate cavitation solution, such as phosphate buffered saline solution, to the cavitation bubble chamber 730.
  • An advantage of two cavitation solution lumens, such as 734 and 736, is that one of the two lumens can be used to add fresh cavitation solution, while the other may allow cavitation solution liquid or gaseous components to be removed from the closed fluid circuit.
  • the user can pressurize first cavitation solution lumen 734 at the first cavitation solution fitting 717 at the proximal end 719 with a syringe filled with fresh cavitation solution, and discharge cavitation solution that has been circulated through the cavitation bubble chamber 730 by way of the second cavitation solution lumen 736 at the second cavitation solution fitting 718 at the proximal end 719.
  • First and second cavitation lumens 734 and 736 create a fluid flow path between the cavitation bubble chamber 730 and proximal end 719 of medical device balloon catheter 701, enabling fluid communication or fluid connection therebetween.
  • This set of features and implementation can remove the need for an opening 723, such as a hole, slit, or passage, at the distal end 713 near the cavitation bubble chamber 720 to remove or add cavitation solution, such as described with reference to FIG. 31.
  • first electrode 726 and second electrode 727 terminate at the proximal end of, or within the cavitation bubble chambers 720 and 730.
  • the intermediate electrode 725 which can be a tubular metallic band coaxial with the guidewire tube 704, is spaced a distance away from the distal end of the first and second electrodes, 726 and 727, at an appropriate distance to ensure consistent sparking across the electrode gaps, 728 and 729, and generation of the required shockwave energy.
  • the spacing of this gap may typically range from between about 100 to about 500 microns.
  • Cavitation solution cavities or lumens 742 and 744 are formed in part by conductive tubes of oval cross-section that also serve as first electrode 741 and second electrode 743.
  • Medical device balloon catheter 740 may also include an inflatable balloon 702 that transitions to a distal balloon tail 705 that seals the distal end of the inflatable balloon 702 near the distal end 713.
  • the distal balloon tail 705 may typically comprise of a polymer that is the same as the inflatable balloon 702 and forms the outer surface of this portion of the balloon catheter 740, where a similar or compatible polymer is typically formed into a taper at the distal end 713 where the distal exit of the guidewire lumen 711 is located.
  • FIG. 35 also shows the electrode gap 728 between first electrode 741 and intermediate electrode 725 and electrode gap 729 between second electrode 743 and intermediate electrode 725.
  • FIG. 36 is a partial schematic, transverse cross-sectional view of medical device catheter 740 at cavitation bubble chamber 745, or CS11 as illustrated in FIG. 35, showing guidewire tube 704, guidewire lumen 711, first electrode tube 741, second electrode tube 743, cavitation bubble tube 721, distal balloon tail 705, and cavitation solution cavities or lumens 742 and 744 formed by electrode tubes 741 and 743.
  • the tubes 741 and 743 may suitably comprise a conductive material, such as copper or stainless steel, where the tubes 741 and 743 may fulfill dual functions of serving as the electrodes and creating the cavitation solution lumens 742 and 744.
  • a conductive material such as copper or stainless steel
  • the tubes 741 and 743 may fulfill dual functions of serving as the electrodes and creating the cavitation solution lumens 742 and 744.
  • FIG. 38 is partial schematic, longitudinal cross-sectional view of a medical device catheter 750 according to an aspect of the present disclosure, showing a sectional view of a portion of medical device catheter 750, including features at the distal end 713.
  • Medical device catheter 750 is similar to medical device catheter 740 described previously, and includes a guidewire lumen 711 formed by a guidewire tube 704, which extends coaxially through a cavitation bubble chamber 745, an intermediate electrode 725, but excludes the inflatable balloon 702 features.
  • Catheter shaft 751 includes lumens and conductors connecting the distal end 713 and cavitation bubble chamber 745 to the proximal end 719 therebetween.
  • Cavitation bubble chamber 745 is formed by a tube, cavitation bubble chamber tube 721.
  • the tubes 741 and 743 may suitably comprise a conductive material, such as copper or stainless steel, where the tubes 741 and 743 may fulfill dual functions of serving as the electrodes and creating the cavitation solution lumens 742 and 744.
  • a conductive material such as copper or stainless steel
  • the tubes 741 and 743 may fulfill dual functions of serving as the electrodes and creating the cavitation solution lumens 742 and 744.
  • Cavitation solution lumens 742 and 744 create a fluid flow path between the cavitation bubble chamber 745 and proximal end 719 of medical device catheter 750, enabling fluid communication or fluid connection therebetween, in the same way as cavitation solution lumens 734 and 736 function in reference to FIG. 33 and FIG. 34 describing medical device balloon catheter 701.
  • Electrode tubes 741 and 743 are shown as an oval shape in cross-section instead of round such that the profile of the medical device catheter can be further decreased, however, round tubes may also be suitable depending on the needs of the medical device and procedure.
  • FIG. 40 illustrates the features of medical device catheter 760 which includes a distal end 713 and proximal end 719 with a catheter shaft 761 therebetween. Medical device catheter 760 also includes a proximal fitting assembly 753 near the proximal end 719 of medical device catheter 760.
  • Catheter shaft 761 is typically a long tube comprising one or more lumens and one or more electrical conductors.
  • FIG. 41 is an enlarged detailed view of the distal portion of medical device catheter 760 and catheter shaft 761, illustrating the distal end 713 with the outer tube 766 and tapered transition 759 hidden as dotted lines such that the internal features of distal end 713 of catheter shaft 761 can be illustrated.
  • Medical device catheter 760 and catheter shaft 761 include a guidewire tube 756 which has a distal end 758 and a lumen 757 sized to accommodate a guidewire for use during an interventional procedure.
  • Medical device catheter 760 and catheter shaft 761 also include first cavitation solution tube 764 that has a distal end 778 and forms a first cavitation solution lumen or cavity 763.
  • Catheter shaft 761 also includes a series of electrodes for the purposes of creating a series of shockwave producing sparks, arcs, or plasma channels across the electrode gaps formed therein.
  • FIG. 41 illustrates a second powered electrode 769, which includes an insulated covering or coating 782 such that an exposed or uninsulated portion 783 is at the distal end of electrode 769.
  • a fourth intermediate electrode 772 is illustrated and includes an insulated covering or coating 790 such that the proximal end 792 and distal end 791 are exposed or uninsulated.
  • a third intermediate electrode 771 is illustrated and includes an insulated covering or coating 787 such that the proximal end 789 and distal end 788 are exposed or uninsulated.
  • FIG. 41 illustrates third electrode gap 775 formed between the second intermediate electrode 762 and the distal uninsulated end 788 of third intermediate electrode 771, fourth electrode gap 776 formed between the proximal uninsulated end 789 of third intermediate electrode 771 and distal uninsulated end 791 of fourth intermediate electrode 772, and fifth electrode gap 777 formed between the proximal uninsulated end 792 of fourth intermediate electrode 772 and distal uninsulated end 783 of second powered electrode 769.
  • the first electrode gap 773 and second electrode gap 774 are shown and described with respect to FIG. 44 below.
  • FIG. 42 is partial schematic, longitudinal cross-sectional view of a medical device catheter 760 according to an aspect of the present disclosure, showing a sectional view of a portion of medical device catheter 760 and catheter shaft 761, including the features at the distal end 713 as well as second intermediate electrode 762.
  • Catheter shaft 761 includes a guidewire lumen 757 formed by a guidewire tube 756 and a cavity 754 within a tapered transition 759 to a smaller diameter at distal end 713, where cavity 754 is distal to the distal end 758 of guidewire tube 756.
  • Guidewire tube 756 extends through a cavitation bubble chamber 765 and at least a portion of a second cavitation solution lumen or cavity 767.
  • Cavitation bubble chamber 765 and second cavitation solution lumen or cavity 767 are formed by outer tube 766. Within outer tube 766 and cavitation bubble chamber 765 is the distal end 778 of first cavitation solution lumen or cavity 763 formed in part by first cavitation solution tube 764.
  • FIG. 43a is a partial schematic, transverse cross-sectional view of medical device catheter 760 through a portion of cavitation bubble chamber 765, or CS13 as illustrated in FIG. 42, and showing guidewire tube 756, guidewire lumen 757, uninsulated distal end 788 of third intermediate electrode 771 (shown in FIG. 41), second intermediate electrode 762, outer tube 766, cavitation bubble chamber 765, second cavitation solution lumen or cavity 767, and first cavitation solution lumen or cavity 763 formed by a first cavitation solution tube 764.
  • FIG. 44 is a partial schematic longitudinal top view of the distal end 713 of medical device catheter 760 and catheter shaft 761 shown with reference to FIGS. 40 - 43, with the outer tube 766 and tapered transition 759 hidden as dotted lines such that the internal features of distal end 713 of catheter shaft 761, and electrode configuration can be further illustrated.
  • FIG 44 can be conceptualized as a top view projection where, for reference, FIG. 42 is a side cross-sectional view projection.
  • medical device catheter 760 and catheter shaft 761 include a guidewire tube 756 which has a distal end 758 and a lumen 757 sized to accommodate a guidewire for use during an interventional procedure.
  • Medical device catheter 760 and catheter shaft 761 also include first cavitation solution tube 764 that has a distal end 778 and forms a first cavitation solution lumen or cavity 763.
  • Catheter shaft 761 also includes a series of electrodes for the purposes of creating a series of shockwave producing sparks, arcs, or plasma channels across the electrode gaps formed therein.
  • FIG. 44 illustrates a first powered electrode 768, which includes an insulated covering or coating 780 such than an exposed or uninsulated portion 781 is at the distal end of the electrode 768.
  • a first intermediate electrode 770 is illustrated and includes an insulated covering or coating 784 such that the proximal end 786 and distal end 785 are exposed or uninsulated.
  • a cavitation bubble chamber 765 is formed by an outer tube 766 at the distal end 713 of medical device catheter 760 and catheter shaft 761.
  • cavitation bubble chamber 765 may house within it two (2) powered electrodes, a first powered electrode 768 (shown with respect to FIG. 44) and a second powered electrode 769; four (4) intermediate electrodes, including a first intermediate electrode 770, a second intermediate electrode 762, a third intermediate electrode 771, and a fourth intermediate electrode 772; and a first cavitation solution tube 764 forming a first cavitation solution lumen 763, for example.
  • the first powered electrode 768 is connected to a positive channel of a high voltage pulse generator 457 (such as shown and described with respect to FIG. 22) and the second powered electrode 769 is connected to a negative channel of the pulse generator 457, and a sufficiently high voltage pulse is applied between the powered electrodes, then provided the positioning of the electrode gaps are strategically staggered, as illustrated, such that electrical arcing or sparking will occur only at the electrode gaps to complete the high voltage pulse circuit, the electrical arcing or sparking across each electrode gap will create an individual shockwave and may also create an associated cavitation bubble.
  • the second intermediate electrode 762 is the most electrically positive distal electrode in the electrode chain such that it is positioned to only allow electrical arcing at electrode gaps 774 and 775 without requiring selective electrically insulated coverings or coatings. Further, the uninsulated portions of the other electrodes are positioned to be strategically staggered such that electrical arcing will only occur at electrode gaps 773, 776, and 777.
  • the electrodes can be made of electrically conductive materials for example graphite or metals such as copper, stainless steel, tungsten, platinum, platinum alloys, nitinol, or other metal alloys. Examples of insulative coatings or coverings include enamel, polyurethane, polyamide-imide, and polyimide.
  • Suitable electrically conductive wire for electrodes include magnet wire, which includes a copper core with a polymer coating as an insulated covering.
  • the electrodes are shown as round wire but could also be flat wire, or stranded wire, small or fine wire bundled together to form a conductor, as non-limiting examples.
  • the distal end 778 of the first cavitation solution lumen 763 is near or at the distal end of the cavitation bubble chamber 765 such that filling the cavitation bubble chamber 765 with a cavitation solution through the first cavitation solution lumen 763 would help facilitate removing any generated cavitation bubbles by evacuating the cavitation solution through the second cavitation solution lumen 767 and any lumens proximal and fluidly connected to second cavitation solution lumen 767.
  • the uninsulated distal end 788 of third intermediate electrode 771 can extend distally past the distal boundary 752 of cavitation bubble chamber 765 in a manner similar to second intermediate electrode 762.
  • FIG. 45 illustrates a first powered electrode 768, which includes an insulated covering or coating 780 such than an exposed or uninsulated portion 781 is at the distal end of the electrode 768, a first intermediate electrode 794, a second intermediate electrode 795, a third intermediate electrode 796, a fourth intermediate electrode 797, and a second powered electrode 769, which includes an insulated covering or coating 782 such that an exposed or uninsulated portion 783 is at the distal end of electrode 769.
  • FIG. 45 illustrates a first powered electrode 768, which includes an insulated covering or coating 780 such than an exposed or uninsulated portion 781 is at the distal end of the electrode 768, a first intermediate electrode 794, a second intermediate electrode 795, a third intermediate electrode 796, a fourth intermediate electrode 797, and a second powered electrode 769, which includes an insulated covering or coating 782 such that an exposed or uninsulated portion 783 is at the distal end of electrode 769.
  • FIG. 45 illustrates a first powered electrode 768, which includes an
  • the intermediate electrodes are represented as round wires of a given length, however, the intermediate electrodes may also comprise ring electrodes similar to intermediate electrode 725 or tubular electrode elements, such as tubular electrode elements 541 describe previously.
  • the intermediate ring electrodes or tubular electrodes similar to 725 or 541 described previously, would preferably be coaxial with either the guidewire lumen 757 and guidewire tube 756, or coaxial with the first cavitation solution lumen or cavity 763 and first cavitation solution tube 764.
  • intermediate electrodes coaxial with guidewire tube 756 and first cavitation solution tube 764 there may be advantages to a combination of intermediate electrodes coaxial with guidewire tube 756 and first cavitation solution tube 764, for example, the distal most intermediate electrode could be coaxial with the guidewire tube 756 and comprised of a radiopaque material such as tungsten or a platinum alloy to provide a marker of location under fluoroscopy during an interventional procedure, and the more proximal intermediate electrodes could be smaller and coaxial with the first cavitation solution tube 764 and comprised of a material that is less expensive such as stainless steel.
  • Intermediate electrodes may suitably comprise partial rings, such as a semi-circular cylinders, or even flat wire that is coiled in a spiral to facilitate positioning the intermediate electrodes during manufacturing.
  • the features would be positioned near the distal end (not shown) of the medical device catheter 810 and catheter shaft 811, such as the distal end 713 shown with reference to FIG. 40 for medical device catheter 760.
  • a distal exit (not shown) for the rapid exchange guidewire lumen 828 is also positioned at the distal end (not shown) of medical device catheter 810.
  • a suitable example of such RX guidewire features is also shown and described with reference to FIGS. 17 - 21 describing a rapid exchange lumen 513 with a distal end 514 functioning as a distal exit for the guidewire, for example.
  • FIG. 47 is a partial schematic longitudinal top view of the distal end of medical device catheter 810 and catheter shaft 811, with the outer jacket 818 hidden as dotted lines and tube 816 not shown such that the internal features of medical device catheter 810 and catheter shaft 811 and electrode configuration can be further illustrated.
  • FIG 47 can be conceptualized as a top view projection where, for reference, FIG. 46 is a side cross-sectional view projection.
  • FIG. 47 illustrates the distal opening 814 of a first tube 813, a portion of first powered electrode 819, a portion of second powered electrode 820, a first intermediate electrode 821, a second intermediate electrode 822, a first electrode gap 823, a second electrode gap 824, a third electrode gap 825, a portion of distal plug 826, rapid exchange guidewire tube 827, and reinforcing element 830.
  • FIG. 46 and FIG. 47 is a rapid exchange medical device catheter 810 capable of delivering electrohydraulic lithotripsy generated shockwaves to a target calcified artery in a manner like described with reference to medical device catheter 760 previously.
  • Medical device catheter 810 also incorporates features similar to medical device catheter 760 including fitting assembly 715 which includes a first cavitation solution fitting 717, and a second cavitation solution fitting 718 that are connected to a first cavitation solution lumen or cavity 812 and a second cavitation solution lumen or cavity 817 which creates fluid flow paths, or connections, extending between the cavitation bubble chamber 815 and first and second cavitation solution fittings, 717 and 718.
  • Fitting assembly 715 also includes an electrical connector 714 that includes at least two electrical connector pins, a first electrical connector pin 707 and a second electrical connector pin 708. Electrical connector 714 and the first and second electrical connector pins 707 and 708 respectively are adapted to electrically couple, or connect, a high voltage pulse generator to first powered electrode 819 and a second powered electrode 820 in the cavitation bubble chamber 815.
  • the rapid exchange guidewire lumen 828 formed in part by rapid exchange guidewire tube 827 is similar to rapid exchange guidewire lumen 513 of rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 described previously.
  • the rapid exchange guidewire lumen 828 has advantages as the profile of non-overlapping configurations are smaller and lower profile for improved tracking through a tight stenotic arterial segment during a procedure.
  • proximal exit 829 through openings in the side wall of the RX guidewire tube 827, reinforcing element 830, and jacket 818 which covers the distal end of the catheter shaft 811.
  • the jacket 818 also covers at least a portion of tube 816 forming cavitation bubble chamber 815 and at least a portion of second cavitation solution lumen 817.
  • the opening in the side wall of the catheter shaft 811 forming proximal exit 829 may create a weak point where kinking may occur in use.
  • the reinforcing element 830 is coaxial with a portion of the catheter shaft 811 and reinforces catheter shaft 811 in the region of the proximal exit 829 to minimize the likelihood of kinking during use.
  • Reinforcing element 830 may be manufactured from a metal alloy, such as Stainless Steel or Nitinol, laser cut from a tube to form an opening in the sidewall in the region of the proximal exit 829.
  • the tube 816 forming cavitation bubble chamber 815 and at least a portion of second cavitation solution lumen 817 may be manufactured at a known diameter or size and is preferably not otherwise inflatable.
  • tube 816 could be manufactured from a thermoset plastic, such as polyimide with a thin wall, on the order of about .001” to .003” in thickness.
  • tube 816 could be manufactured from common thermoplastic catheter materials, such PEBAX or nylon, to create a sufficiently rigid tubular substrate necessary to form a cavitation bubble chamber 815.
  • Tube 816 may also comprise a composite or laminated structure, including a combination of polymer substrates and braided or coiled metallic or polymer wire or fiber as further reinforcement.
  • Jacket 818 could comprise a polymer, such as PEBAX or nylon, and be manufactured to cover the distal end of the catheter shaft 811 using a thermal reflow process common in catheter manufacturing.
  • the features of medical device catheter 810 could be incorporated into an adapter design similar to rapid exchange (RX) intravascular lithotripsy (IVL) adapter 510 described previously by further utilizing the tube 816 forming cavitation bubble chamber 815 and at least a portion of second cavitation solution lumen 817 as an elongated element or central tube, such as central tube 462 of attachment mechanism 467 of adapter 510.
  • RX rapid exchange
  • IVL intravascular lithotripsy
  • FIG. 46 and FIG. 47 further illustrate a distal plug 826 which occludes the lumen of tube 816 to form a distal boundary 752 of the cavitation bubble chamber 815.
  • Distal plug 826 also secures a distal end of the first powered electrode 819, which extends beyond the distal boundary 752 of cavitation bubble chamber 815.
  • the rapid exchange guidewire lumen 828 proximal exit 829 and associated features are positioned distal to the distal boundary 752 of cavitation bubble chamber 815, which may allow for a smaller overall profile of medical device catheter 810 in contrast with designs that require the guidewire lumen to extend through the cavitation bubble chamber 815 and associated electrodes and other IVL features.
  • FIG. 49 also illustrates the first powered electrode 819 with a round cross-section but could also have a rectangular, oblong, square or other geometric cross-section as desired, for example, to reduce the overall profile of the catheter shaft 841.
  • FIG. 48 also illustrates how biasing or positioning the first powered electrode 819 to one side of the cavitation bubble chamber 815 enables lowering the overall profile or transverse cross-sectional size of the catheter shaft 841.
  • Second powered electrode 820, tube 813 forming first cavitation solution lumen 812, and intermediate electrodes 821 and 822 may also likewise be biased to one side as shown to achieve the lower overall profile of catheter shaft 841.
  • FIG. 50 is partial schematic, longitudinal cross-sectional view of a medical device catheter 845 according to an aspect of the present disclosure, showing a sectional view of a portion of medical device catheter 845 and catheter shaft 846, illustrating features of a cavitation bubble chamber 815 having distal boundary 752, a first cavitation solution lumen 812, a first tube 813 forming first cavitation solution lumen 812, a distal opening 814 of first cavitation solution lumen 812, a second cavitation solution lumen 817, a tube 833 forming cavitation bubble chamber 815 and at least a portion of second cavitation solution lumen 817, a first powered electrode 819, a second powered electrode 820, a first intermediate electrode 821, a second intermediate electrode 822, a first electrode gap 823, a second electrode gap 824, a third electrode gap 825, a distal cavitation bubble chamber plug 826, a rapid exchange (RX) guidewire tube 827, a rapid exchange (RX) guide
  • the tube 833 has been cut, notched, or otherwise manufactured with an edge 831 that extends distally past the distal end 809 of first powered electrode 81 , such that tube 833 also has an edge 832 that is proximal to the proximal edge 835 of rapid exchange guidewire tube 827 and proximal guidewire exit 829.
  • Overlapping a portion of the tube 833, first powered electrode 819 and rapid exchange guidewire tube 827 in the region between the proximal end 835 of the rapid exchange guidewire tube 827 and edge 832 of tube 833 where a proximal guidewire exit 829 is formed, provides extra structural support in this region while maintaining a low transfer cross-sectional profile.
  • cavitation bubble chamber 815 and associated electrodes and IVL features being positioned proximal to the separate guidewire lumen 828 and proximal exit 829, such that the guidewire 834 and lumen do not have to pass through those IVL features.
  • rapid exchange guidewire lumen 828 is formed by a tube 827, but as an alternate example, the lumen 828 could be formed by the jacket or polymer body 818 of the catheter shaft 851 in that portion, without the need for a separate tube.
  • FIG 51a and FIG 51b also illustrate the bottom distal edge 831 of tube 852 that extends distally beyond top proximal edge 832, such that edge 832 of tube 852 is proximal to the edge 831 of tube 852, electrode gap 825 and cavitation bubble chamber 815, likewise, first tube 813 forming at least a portion of a first cavitation solution lumen 812 includes a top proximal edge 805 at the distal opening 814 of a first cavitation solution lumen 812 and a bottom distal edge 804 which extends distally past the distal boundary 752 of cavitation bubble chamber 815.
  • FIG. 51a and 51b illustrate another suitable configuration where both the first powered electrode 819, and a portion of tube 852 forming a bottom portion of cavitation bubble chamber 815 overlap rapid exchange guidewire tube 827 in a portion distal to the proximal guidewire exit 829 and proximal end 835 of rapid exchange guidewire tube 827.
  • This can be conceptualized where in this overlapped region, the first powered electrode 819 is positioned or located next to a portion of the inside surface of tube 852 and a portion of the outside surface of rapid exchange guidewire tube 827 is positioned next to or adjacent the outside surface of tube 852.
  • first powered electrode 819, a portion of tube 852, and a portion of rapid exchange guidewire tube 827 form a structure where a portion of the tube 852 is disposed between a portion of the first powered electrode 819 and a portion of the rapid exchange guidewire tube 827.
  • the tube 852 has been cut, notched, or otherwise manufactured with an edge 831 that extends distally past the distal end 809 of first powered electrode 819, such that tube 852 also has an edge 832 that is proximal to third electrode gap 825.
  • cavitation bubble chamber 815 is formed by a portion of tube 852 and outer jacket 818.
  • FIG. 51a and 51b further illustrate first and second intermediate electrodes 821 and 822 as rings or portions of a tube that do not form a complete circle.
  • the first and second intermediate electrodes 821 and 822 may be half cylinders, having a transverse cross-sectional arc of 180 degrees. This configuration would bias the arcing to the top side of the cavitation bubble chamber 815 as illustrated.
  • first powered electrode 819 does not require any insulative coating in the region of the cavitation bubble chamber 815 or in the first cavitation solution lumen 812 because first cavitation solution tube 813 functions as an electrical barrier separating first powered electrode 819 from the intermediate 821, 822 and second powered electrodes 820.
  • FIG. 51a and 51b also illustrates first cavitation solution tube 813 has been cut, notched, or otherwise manufactured with a distal edge 804 that extends distally past the distal boundary 752 of the cavitation bubble chamber 815 and a proximal edge 805 at the distal opening 814 of first cavitation solution lumen 812.
  • distal edge 804 of first cavitation solution tube 813 is secured to and oriented relative to first powered electrode by way of the distal plug 826.
  • This configuration ensures the desired orientation of the intermediate electrodes 821 and 822 relative to the first powered electrode 819, including to bias the spark gap 823 to occur between the top of the first powered electrode 819 as illustrated and the nearest intermediate electrode 822 where there is more cavitation solution volume present.
  • tube 857 is coaxial and overlaps with tube 813.
  • an electrical continuity configuration of a second powered electrode circuit which includes the second powered electrode 820 beginning at the proximal end of the cavitation bubble chamber 815, transitioning to an intermediate second powered electrical conductor 854 and further transitioning to a proximal second powered electrical conductor 855.
  • a proximal end of second powered electrode 820 may be welded, soldered, brazed or otherwise electrically connected to a distal end of electrical conductor 854 where the proximal end of electrical conductor 854 may also be welded, soldered, brazed or otherwise electrically connected to a distal end of electrical conductor 855.
  • Electrical conductor 854 is illustrated as a coil or spiral coaxial with tube 813.
  • FIG. 54 is partial schematic, longitudinal cross-sectional view of a tube 813 suitable for use in the medical device catheter 850 configuration shown and described with reference to FIG. 51a and 51b, for example, and forming a first cavitation solution lumen 812 having a distal opening 814 according to another aspect of the present disclosure.
  • FIG. 54 illustrates a notch or cut 806 formed or created at the distal end of tube 813 forming a distal edge 804 at the bottom of the tube 813 extending beyond a proximal edge 805 at the top of the tube 813 around distal opening 814.
  • Sufficient cavitation solution circulation may be accomplished by simultaneously pressurizing first cavitation solution fitting 717 and suctioning at second cavitation solution fitting 718 as well as pressurizing solely or suctioning solely provided there is a sufficient reservoir of cavitation solution connected to the first cavitation solution fitting 717.

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Abstract

Un cathéter de dispositif médical comprend un premier tube comprenant une première lumière de solution de cavitation ayant une ouverture distale ; et un second tube logeant le premier tube et comprenant une chambre de bulles de cavitation, une seconde lumière de solution de cavitation en communication fluidique avec la première lumière de solution de cavitation à travers l'ouverture distale, et un bouchon distal au niveau d'une extrémité distale de la chambre de bulles de cavitation pour créer une limite distale de la chambre de bulles de cavitation. Une sortie proximale de fil-guide à échange rapide est positionnée de manière distale par rapport à la limite distale de la chambre de bulles de cavitation et en communication avec une lumière de fil-guide ; et une première électrode alimentée s'étend à travers le premier tube et la première lumière de solution de cavitation et la chambre de bulles de cavitation et dans le bouchon distal au-delà de la limite distale de la chambre de bulles de cavitation.
PCT/US2023/031907 2023-01-11 2023-09-01 Cathéter de lithotritie intravasculaire Ceased WO2024151291A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US18/095,992 US20230218309A1 (en) 2022-01-11 2023-01-11 Adapter for an electrical modular catheter system
US18/095,992 2023-01-11
US18/144,208 2023-05-07
US18/144,208 US20230270459A1 (en) 2022-01-11 2023-05-07 Intravascular lithotripsy catheter

Publications (1)

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WO2024151291A1 true WO2024151291A1 (fr) 2024-07-18

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7229431B2 (en) * 2001-11-08 2007-06-12 Russell A. Houser Rapid exchange catheter with stent deployment, therapeutic infusion, and lesion sampling features
US10898213B2 (en) * 2014-12-30 2021-01-26 The Spectranetics Corporation Electrically-induced pressure wave emitting catheter sheath
US20220265295A1 (en) * 2018-10-25 2022-08-25 Medtronic Vascular, Inc. Cavitation catheter
US11478261B2 (en) * 2019-09-24 2022-10-25 Shockwave Medical, Inc. System for treating thrombus in body lumens
US20220338890A1 (en) * 2021-02-26 2022-10-27 Fastwave Medical Inc. Intravascular lithotripsy
US20230270459A1 (en) * 2022-01-11 2023-08-31 Covellus Llc Intravascular lithotripsy catheter

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7229431B2 (en) * 2001-11-08 2007-06-12 Russell A. Houser Rapid exchange catheter with stent deployment, therapeutic infusion, and lesion sampling features
US10898213B2 (en) * 2014-12-30 2021-01-26 The Spectranetics Corporation Electrically-induced pressure wave emitting catheter sheath
US20220265295A1 (en) * 2018-10-25 2022-08-25 Medtronic Vascular, Inc. Cavitation catheter
US11478261B2 (en) * 2019-09-24 2022-10-25 Shockwave Medical, Inc. System for treating thrombus in body lumens
US20220338890A1 (en) * 2021-02-26 2022-10-27 Fastwave Medical Inc. Intravascular lithotripsy
US20230270459A1 (en) * 2022-01-11 2023-08-31 Covellus Llc Intravascular lithotripsy catheter

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